Analysis of the optional third open-label treatment cycle (Cycle 3) was completed in October 2020. Cycle 3 was focused on safety and all patients could elect to receive HyBryte™ treatment of all their lesions for an additional 6 weeks or up to 18 weeks in total. Of note, 66% of patients elected to continue with this optional safety cycle of the study. Of the subset of patients that received HyBryte™ throughout all three cycles of treatment (18 weeks), respectively.49% of them demonstrated a treatment response (p=0.046 vs. patients completing 12 weeks of HyBryte™ treatment in Cycle 2; p<0.0001 vs. patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.
In addition, continued analysis of results from the protocol mandated efficacy cycles (Cycles 1 and 2) of the study revealed that 12 weeks of treatment (Cycle 2) with HyBryte™ is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions when compared to Cycle 1 placebo lesion responses, further demonstrating the unique benefits of the more deeply penetrating visible light activation of hypericin.
SGX301HyBryte™ has received Orphan Drug designation as well as Fast Track designation from the U.S. Food and Drug Administration (“FDA”).FDA. The Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven-year term of market exclusivity for SGX301HyBryte™ upon final FDA approval, Orphan Drug designation also positions us to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of FDA user fees for the potential submission of a New Drug Application (“NDA”)NDA for SGX301,HyBryte™, and certain tax credits. In addition, Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast Track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, we will bewere eligible to submit a NDA for SGX301HyBryte™ on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for Fast Track development programs ordinarily will be eligible for priority review. SGX301HyBryte™ for the treatment of CTCL also was granted Orphan Drug designation from the European Medicines Agency (“EMA”)EMA Committee for Orphan Medical Products and Promising Innovative Medicine (“PIM”) designation from the MedicinesMHRA, as well as Innovation Passport under the Innovative Licensing and Healthcare Products Regulatory AgencyAccess Pathway (“MHRA”ILAP”) in the United KingdomUK.
During January 2021, we signed an exclusive Supply, Distribution and Services Agreement with The Daavlin Distributing Co. (“UK”Daavlin”), securing long-term supply and distribution of a commercially ready light device, which is an integral component of the regulatory and commercial strategy for HyBryte™ for the treatment of CTCL. Pursuant to the agreement, Daavlin will exclusively manufacture the proprietary light device for use with HyBryte™ for the treatment of CTCL. Upon approval of HyBryte™ by the FDA, we will promote HyBryte™ and the companion light device, and facilitate the direct purchase of the device from Daavlin. Daavlin will exclusively distribute and sell the HyBryte™ light device to us, physicians and patients.
In April 2021, the FDA conditionally accepted HyBryte™ as the proposed brand name for SGX301 or synthetic hypericin, in the treatment of early stage CTCL. The name HyBryte™ was developed in compliance with the FDA’s Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. The FDA’s conditional approval validates HyBryte™ as a proprietary name that is consistent with the FDA’s goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the HyBryte™ proprietary name is conditioned on FDA approval of the product candidate, SGX301.
In May 2021, HyBryte™ was awarded an "Innovation Passport" for the treatment of early stage CTCL in adults under the UK’s ILAP. The decision to award the Innovation Passport to the HyBryte™ program was made by the Innovative Licensing and Access Pathway Steering Group, which is comprised of representatives from MHRA, the National Institute for Health and Care Excellence (“NICE”), and the Scottish Medicines Consortium (“SMC”). ILAP was launched at the start of 2021 to accelerate the development and access to promising medicines, thereby facilitating patient access to new medicines. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with the MHRA, NICE, and SMC. The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day accelerated assessment, rolling review and a continuous benefit risk assessment.
As a result of discussions with the FDA regarding the HyBryte™ NDA submission and due to disruptions caused by the global COVID-19 pandemic resulting in delays by the commercial active pharmaceutical ingredient (“API”) contract manufacturer affecting the timing of availability of the pre-requisite amount of accrued stability data required to file the NDA,
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we filed the NDA with the FDA in December of 2022. We did not pursue a rolling NDA submission, so that we could provide additional supportive data in the NDA filing.
We initiatedIn June 2021, we received a Paediatric Investigation Plan (“PIP”) waiver from the EMA for HyBryte™. As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a PIP outlining their strategies for investigation of the new medicinal products in the pediatric population. In some instances, a waiver negating the need for a PIP for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate, as is the case for HyBryte™ in CTCL which is extremely rare in children.
In September 2021, we were granted orphan drug designation for the active ingredient hypericin for the treatment of T-cell lymphoma, extending the target population beyond CTCL as previously granted by the FDA.
In July 2022, the results of our pivotalsuccessful Phase 3 clinicalFLASH study of SGX301evaluating HyBryte™ for the treatment of CTCL during December 2015. This trial, referredwere published in the Journal of the American Medical Association (JAMA) Dermatology.
In July 2022, we received agreement from the FDA on an initial pediatric study plan (“iPSP”) for HyBryte™ for the treatment of CTCL. The agreed iPSP stipulates that we intend to asrequest a full waiver of pediatric studies upon submission of the “FLASH”NDA. Agreement with FDA on an iPSP is one of the regulatory requirements that must be met prior to submitting a NDA.
In September 2022, the FDA awarded an Orphan Products Development grant to support the evaluation of HyBryte™ for expanded treatment in patients with early-stage CTCL. The grant, totaling $2.6 million over four years, was awarded to a prestigious academic institution that was a leading enroller in the published positive Phase 3 FLASH study (FluorescentLightActivatedSyntheticHypericin), aims to evaluatein the response to SGX301 as a skin directed therapy to treattreatment of early stage CTCL. We are actively enrolling patients
In December 2022, we submitted the HyBryte™ NDA for the treatment of CTCL with approximately thirty CTCL centers acrossthe FDA.
In February 2023, we received a RTF letter from the FDA for the HyBryte™ NDA. Upon preliminary review, the FDA determined that the NDA was not sufficiently complete to permit substantive review.
In April 2023, the United States Adopted Names (“U.S.”USAN”) participatingCouncil approved the use of the nonproprietary name of “hypericin sodium” for the novel active ingredient in this pivotal trial. Theboth HyBryte™ (research name SGX301) for the treatment of CTCL and SGX302 for the treatment of mild-to-moderate psoriasis.
In April 2023, we had a Type A meeting with the FDA to clarify and respond to the issues identified in the RTF letter received from the FDA and to seek additional guidance concerning information that the FDA would require for a resubmitted NDA to be deemed acceptable to file, in order to advance HyBryte™ towards marketing approval and U.S. commercialization. In order to accept an NDA filing for HyBryte™, the FDA is requiring positive results from a second, Phase 3 protocol is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial and will seekpivotal study in addition to enroll approximately 120 evaluable subjects. The trial will consist of three treatment cycles, each of eight weeks duration. Treatments will be administered twice weekly for the first six weeks and treatment response will be determined at the end of the eighth week. In the first treatment cycle, approximately 80 subjects will receive SGX301 and 40 will receive placebo treatment of their index lesions. In the second cycle, all subjects will receive SGX301 treatment of their index lesions, and in the third cycle all subjects will receive SGX301 treatment of all of their lesions. The majority of subjects enrolled to date have elected to continue into the third optional, open-label cycle of the study. We continue to work closely with the Cutaneous Lymphoma Foundation, as well as the National Organization for Rare Disorders. Subjects will be followed for an additional six months after their last evaluation visit. The primary efficacy endpoint will be assessed on the percentage of patients in each of the two treatment groups (i.e., SGX301 and placebo) achieving a partial or complete response of the treated lesions, defined as a ≥ 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (“CAILS”) score for three index lesions at the Cycle 1 evaluation visit (Week 8) compared to the total CAILS score at baseline. Other secondary measures will assess treatment response including duration, degree of improvement, time to relapse and safety.
During September 2017, the National Cancer Institute (“NCI”), part of the National Institutes of Health (“NIH”) awarded us a Small Business Innovation Research (“SBIR”) grant of approximately $1.5 million over two years to support the conduct of our pivotal, Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication. Based on this feedback, we have decided to collaboratively engage in discussions with the FDA in order to define the protocol and evaluate the feasibility of conducting the additional clinical trial.
In May 2023, we were granted a follow-on Type A meeting with the FDA to initiate formal discussions regarding the protocol design of a second, Phase 3 pivotal study evaluating SGX301 (synthetic hypericin) asHyBryte™ in the treatment of CTCL in support of potential FDA marketing approval. These protocol discussions with the FDA remain ongoing. We will provide further update once final FDA clarity is obtained. Additionally, we are currently also evaluating the potential for HyBryte™ marketing approval in Europe.
In August 2023, patient enrollment was opened for the investigator-initiated study (“IIS”). IIS is supported by an Orphan Products Development grant of $2.6 million over four years awarded by the FDA to a prestigious academic institution that was a leading enroller in the published positive Phase 3 FLASH study in the treatment forof early stage CTCL.
The IIS will evaluate the expanded treatment, including up to 12 months of treatment, with HyBryte™ in patients with early-stage CTCL.
We estimate the potential worldwide market for SGX301HyBryte™ is in excess of $250 million for all applications, including the treatment of CTCL. This potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.
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Cutaneous T-Cell Lymphoma
CTCL is a class of non-Hodgkin’s lymphoma (“NHL”), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs, which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These skin-trafficking malignant T-cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors. Mycosis fungoides (“MF”) is the most common form of CTCL. It generally presents with skin involvement only, manifested as scaly, erythematous patches. Advanced disease with diffuse lymph node and visceral organ involvement is usually associated with a poorer response rate to standard therapies. A relatively uncommon sub-group of CTCL patients present with extensive skin involvement and circulating malignant cerebriform T-cells, referred to as Sézary syndrome. These patients have substantially graver prognoses (expected five-year survival rate of 24%), than those with MF.
MF (expected five-year survival rate of 88%).
CTCL mortality is related to stage of disease, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no FDA-approved drug for front-line treatment of early stage CTCL. Treatment of early-stage disease generally involves skin-directed therapies. One of the most common unapproved therapies used for early-stage disease is oral 5 or 8-methoxypsoralen (“Psoralen”) given with ultraviolet A (“UVA”) light, referred to as PUVA, which is approved for dermatological conditions such as disabling psoriasis not adequately responsive to other forms of therapy, idiopathic vitiligo and skin manifestations of CTCL in persons who have not been responsive to other forms of treatment. Psoralen is a mutagenic chemical that interferes with DNA causing mutations and other malignancies. Moreover, UVA is a carcinogenic light source that when combined with the Psoralen, results in serious adverse effects including secondary skin cancers; therefore, the FDA requires a Black Box warning for PUVA.
CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with NHL. We estimate, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it affects over 20,000 individuals in the U.S., with approximately 2,800 new cases seen annually.
SGX302 – for Treating Mild-to-Moderate Psoriasis
SGX302 (synthetic hypericin) is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the dysregulated T-cells found in psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using UV light associated with more severe potential long-term toxicities. The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin (much more than UV light) potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH study in CTCL. Further, this treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UVA or UVB exposure. The use of SGX302 coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis.
In September 2021, following the validation of synthetic hypericin’s biologic activity in the positive Phase 3 FLASH study in CTCL, as well as positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, we decided to expand this novel therapy into a Phase 2a clinical trial in mild-to-moderate psoriasis.
In June 2022, we received FDA IND clearance for our Phase 2a clinical trial (protocol number HPN-PSR-01) titled, "Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis." In December 2022, we initiated patient enrollment for the Phase 2a study (protocol number HPN-PSR-01) evaluating SGX302 in the treatment of mild-to-moderate psoriasis. The Phase 2a clinical trial (protocol number HPN-PSR-01) will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of the body. In both Parts A and B, all patients will apply the study drug twice per week and activate the drug with visible light 24 ± 6 hours later using the supplied visible light devices and according to the manufacturer's instructions. Patients will undergo treatments for a total of 18 weeks and, on completion, will be followed for a four-week follow-up period in which patients will not receive other psoriasis treatments. In Part A, five to ten patients will be assigned open-label SGX302 (0.25% hypericin) at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment. Active dermatologic
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assessment of treated lesions for adverse events will be performed immediately before and during light treatments. Patients will be assessed for overall disease status through four weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices. Routine safety data also will be collected.
In October 2022, we announced the formation of a Medical Advisory Board to provide medical/clinical strategic guidance to advance the Phase 2a clinical development of SGX302 for the treatment of mild-to-moderate psoriasis.
In July 2023, we expanded the Phase 2a trial of SGX302 after demonstration of biological effect in the initial five subjects (Cohort 1). The study is expected to enroll at least an additional ten subjects, exploring the use of SGX302 in the standard of care psoriasis setting, prior to undertaking the larger phase of the study.
In January 2024, positive preliminary results of clinical success were demonstrated in the Cohort 2 subjects enrolled in the ongoing Phase 2a study. In the four evaluable patients from Cohort 2 (one patient withdrew early in the treatment course for personal reasons unrelated to the study), two reached a disease status of “Almost Clear” represented by an Investigator Global Assessment score of 1, which is considered the standard clinical measure for treatment success in psoriasis. In addition, the Psoriasis Activity and Severity Index score, another well-characterized measure of treatment success, for patients in Cohort 2 had a mean drop of approximately 50% over the 18-week treatment. SGX302 therapy was well tolerated by all patients with no drug related adverse events identified.
We estimate the potential worldwide market for SGX302 is in excess of $1 billion for the treatment of mild-to-moderate psoriasis. This potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.
Psoriasis
Psoriasis is a chronic, non-communicable, itchy and often painful inflammatory skin condition for which there is no cure. Psoriasis has a significantly detrimental impact on patients' quality of life, and is associated with cardiovascular, arthritic, and metabolic diseases, as well as psychological conditions such as anxiety, depression and suicide. Many factors contribute to development of psoriasis including both genetic and environmental factors (e.g., skin trauma, infections, and medications). The lesions develop because of rapidly proliferating skin cells, driven by autoimmune T-cell mediated inflammation. Of the various types of psoriasis, plaque psoriasis is the most common and is characterized by dry, red raised plaques that are covered by silvery-white scales occurring most commonly on the elbows, knees, scalp, and lower back. Approximately 80% of patients have mild-to-moderate disease. Mild psoriasis is generally characterized by the involvement of less than 3% of the body surface area (“BSA”), while moderate psoriasis will typically involve 3-10% BSA and severe psoriasis greater than 10% BSA. Between 20% and 30% of individuals with psoriasis will go on to develop chronic, inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability. Studies have also associated psoriasis, and particularly severe psoriasis, with an increased relative risk of lymphoma, particularly CTCL. Although psoriasis can occur at any age, most patients present with the condition before age 35.
Treatment of psoriasis is based on its severity at the time of presentation with the goal of controlling symptoms. It varies from topical options including PDT to reduce pain and itching, and potentially reduce the inflammation driving plaque formation, to systemic treatments for more severe disease. Most common systemic treatments and even current topical photo/photodynamic therapy such as UV A and B, carry a risk of increased skin cancer.
Psoriasis is the most common immune-mediated inflammatory skin disease. According to the World Health Organization (“WHO”) Global Report on Psoriasis 2016, the prevalence of psoriasis is between 1.5% and 5% in most developed countries, with some suggestions of incidence increasing with time. It is estimated, based upon review of historic published studies and reports and an interpolation of data that psoriasis affects 3% of the U.S. population or more than 7.5 million people. Current estimates have as many as 60-125 million people worldwide living with the condition. The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027.
Dusquetide
Dusquetide (research name: SGX94) is an innate defense regulator (“IDR”)IDR that regulates the innate immune system to simultaneously reduce inflammation, eliminate infection and enhance tissue healing.
Dusquetide is based on a new class of short, synthetic peptides known as IDRs. It has a novel mechanism of action in that it modulates the body’s reaction to both injury and
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infection and is both simultaneously anti-inflammatory and anti-infective. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens including both antibiotic sensitive and resistant strains, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- or radiation-therapy. IDRs represent a novel approach to the control of infection and tissue damage via highly selective binding to an intracellular adaptor protein, sequestosome-1, also known as p62, which has a pivotal function in signal transduction during activation and control of the innate defense system. Preclinical data indicate that IDRs may be active in models of a wide range of therapeutic indications including life-threatening bacterial infections as well as the severe side-effects of chemo- and radiation-therapy. Additionally, due to selective binding to p62, dusquetide may have potential anti-tumor action.
Dusquetide has demonstrated efficacy in numerous animal disease models including mucositis, oncology, colitis, skin infection and other bacterial infections and has been evaluated in a double-blind, placebo-controlled Phase 1 clinical trial in 84 healthy volunteers with both single ascending dose and multiple ascending dose components. Dusquetide was shown to have a good safety profile and be well-tolerated in all dose groups when administered by IV over 7 days and was consistent with safety results seen in pre-clinical studies. We believe that market opportunities for dusquetide include, but are not limited to, oral and gastrointestinal mucositis, oncology (e.g., breast cancer), acute Gram-positive bacterial infections (e.g., methicillin resistantStaphylococcus aureus (MRSA)(“MRSA”)), acute Gram-negative infections (e.g., acinetobacter, melioidosis), and acute radiation syndrome.
SGX942 – for Treating Oral Mucositis in Head and Neck Cancer
SGX942 is our product candidate containing our IDR technology, dusquetide, targeting the treatment of oral mucositis in head and neck cancer patients. Oral mucositis in this patient population is an area of unmet medical need where there are currently no approved drug therapies. Accordingly, we received Fast Track designation for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients from the FDA. In addition, dusquetide has been granted PIM designation in the UK by the MHRA for the treatment of severe oral mucositisSOM in head and neck cancer patients receiving chemoradiation therapy. The U.S. Patent and Trademark Office has granted the patent titled “Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis”. The newly issued patent claims therapeutic use of dusquetide and related IDR analogs, and adds to composition of matter claims for dusquetide and related analogs that have been granted in the U.S. and worldwide.
We initiated a Phase 2 clinical study of SGX942 for the treatment of oral mucositis in head and neck cancer patients in December of 2013. We completed enrollment in this trial in the second half of 2015, and released positive results in December 2015 released positive preliminary results.2015. In this Phase 2 proof-of-concept clinical study that enrolled 111 patients, SGX942, at a dose of 1.5 mg/kg, successfully reduced the median duration of severe oral mucositisSOM by 50%, from 18 days to 9 days (p=0.099) in all patients and by 67%, from 30 days to 10 days (p=0.040) in patients receiving the most aggressive chemoradiation therapy for treatment of their head and neck cancer. The p-values met the prospectively defined statistical threshold of p<0.1 in the study protocol. A less severe occurrence of oral mucositis, ulcerative oral mucositis (defined as oral mucositis with a WHO score ≥2 corresponding to the occurrence of overt ulceration in the mouth), was also monitored during the study. In the patients receiving the most aggressive chemoradiation therapy, the median duration of oral mucositis was found to decrease from 65 days in the placebo treated patients to 51 days in the patients treated with SGX942 1.5 mg/kg (p=0.099).
In addition to identifying the best dose of 1.5 mg/kg, this study achieved all objectives, including increased incidence of “complete response” of tumor at the one month follow-up visit (47% in placebo vs. 63% in SGX942 at 1.5 mg/kg). Decreases in mortality and decreases in infection rate were also observed with SGX942 treatment, consistent with the preclinical results observed in animal models. Data from this Phase 2 trial are published in the Journal of Biotechnology.
SGX942 was found to be generally safe and well tolerated, consistent with the safety profile observed in the prior Phase 1 study conducted in 84 healthy volunteers. The long-term (12 month) follow-up data was consistent with the preliminary positive safety and efficacy findings. While the placebo population experienced the expected 12-month survival rate of approximately 80%, as defined in the Surveillance, Epidemiology, and End Results statistics 1975-2012 from the National Cancer Institute, the SGX942 1.5 mg/kg treatment group reported a 12-month survival rate of 93% (7% mortality in the SGX942 1.5 mg/kg group compared to 19% in the placebo group). Similarly, tumor resolution (complete response) at 12 months was better in the SGX942 1.5 mg/kg treatment group relative to the placebo population (80% in the 1.5 mg/kg group compared to 74% in the placebo group). The long-term follow-up results from the Phase 2 study are reviewed in “Dusquetide: Reduction in Oral Mucositis associated with Enduring Ancillary Benefits in Tumor Resolution and Decreased Mortality in Head and Neck Cancer Patients” published online in Biotechnology Reports and available at the following link:https://doi.org/10.1016/j.btre.2017.05.002. Reports.
In addition to safety, evaluations of other secondary efficacy endpoints, such as the utilization of opioid pain medication, indicated that the SGX942 1.5mg/kg treatment group had a 40% decrease in the use of opioids at the later stage of the treatment phase of the trial, when oral mucositis is usually most severe and expected to increase paid medication use. This was in contrast to the placebo group, which demonstrated a 10% increase in use of opioids over this same period. Data from this Phase 2 trial was published online in the Journal of Biotechnology. The publication also delineates the supportive nonclinical data in this indication, demonstrating consistency in the qualitative and quantitative biological response, including dose response, across the nonclinical and clinical data sets. The results are available at the following link:http://authors.elservier.com/sd/article/S01681656116315668.
On September 9, 2016, we and SciClone Pharmaceuticals, Inc. (“SciClone”) entered into an exclusive license agreement, pursuant to which we granted rights to SciClone to develop, promote, market, distribute and sell SGX942 in defined territories. Under the terms of the license agreement, SciClone will be responsible for all aspects of development, product
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registration and commercialization in the territories, having access to data generated by us. In exchange for exclusive rights, SciClone will pay us royalties on net sales, and we will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights.
We have received clearance from the FDA to advance the pivotal Phase 3 protocol for SGX942 in the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. Additionally, we have received positive Scientific Advice from the EMA for the development of SGX942 as a treatment for oral mucositis in patients with head and neck cancer. The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, multinational, Phase 3 pivotal study, if successful, in conjunction with the Phase 2 dose-ranging study, is generally considered sufficient to support a marketing authorization application (“MAA”) to the EMA for potential licensure in Europe. The advice also provided several suggestions to strengthen the study design and data collection that will be integrated into the final protocol. Scientific Advice is offered by the EMA to stakeholders for clarification of questions arising during development of medicinal products. The scope of Scientific Advice is limited to scientific issues and focuses on development strategies rather than pre-evaluation of data to support an MAA. Scientific Advice is legally non-binding and is based on the current scientific knowledge which may be subject to future changes.
We had been working with leading oncology centers, a number of which participated in the Phase 2 study, to advance this Phase 3 clinical trial referred to as the “DOM–INNATE” study (Dusquetide treatment inOralMucositis – by modulatingINNATE immunity). Based on the positive and previously published Phase 2 results (Study IDR-OM-01), the pivotalin July 2017, we initiated a Phase 3 clinical trial referred to as the “DOM–INNATE” (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) study. Approximately 50 U.S. and European oncology centers participated in this trial. The Phase 3 protocol (Study IDR-OM-02) will bewas a highly powered, double-blind, randomized, placebo-controlled, multinational trial that will seeksought to enroll approximately 190260 subjects with squamous cell carcinoma of the oral cavity and oropharynx who arewere scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects will bewere randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of chemoradiation therapy (“CRT”). The primary endpoint for the study will bewas the median duration of severe oral mucositis,SOM, which will bewas assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis will beis evaluated using the WHO Grading system. Severe oral mucositisSOM is defined as a WHO Grade of ≥3. Subjects will beare followed for an additional 12 months after the completion of treatment.
During July 2017,In April 2019, the Paediatric Committee of the EMA approved our PIP for SGX942, a prerequisite for filing a Marketing Authorization Application (“MAA”) for any new medicinal product in Europe. The EMA also agreed that we initiatedmay defer conducting the PIP until successful completion of our pivotal Phase 3 study with a controlled roll-outclinical trial of U.S. study sites, and will follow withSGX942, which allowed us to file the additionadult indication MAA prior to completion of European centers in 2018. We anticipate that approximately fifty U.S. and European oncology centers will be participating in thisthe PIP.
In June 2020, the pivotal Phase 3 study.
During September 2017,DOM–INNATE study (Study IDR-OM-02) completed enrollment of 268 subjects. In December 2020, the National Institute of Dental and Craniofacial Research (“NIDCR”), part of the NIH, awarded us a SBIR grant of approximately $1.5 million over two years to support the conductresults of our Phase 3 multinational, randomized, double-blind, placebo-controlledclinical trial for SGX942 showed that the primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group. Despite this clinically meaningful improvement, the variability in the distribution of the data yielded a p-value that was not statistically significant. Other secondary endpoints supported the biological activity of dusquetide, including a statistically significant 50% reduction in the median duration of SOM in the per-protocol population, which decreased from 18 days in the placebo group to 9 days in the SGX942 treatment group (p=0.049), consistent with the findings in the Phase 2 trial (Study IDR-OM-01). Similarly, incidence of SOM also followed this biological trend as seen in the Phase 2 study, evaluatingdecreasing by 16% in the SGX942 (dusquetide)treatment group relative to the placebo group in the per-protocol population. The per-protocol population was defined as the population receiving a minimum of 55 Gy radiation and at least 10 doses of study drug (placebo or SGX942) throughout the intended treatment period, with no major protocol deviations (e.g. breaks in study drug administration longer than 8 days between successive doses).
Following analysis of the full dataset, including the 12-month long-term follow-up safety data in late 2021, we held a meeting with the MHRA to review the study results and to obtain further clarity on the future of the oral mucositis development program. The meeting was informative with the outcome being that based on the SGX942 biologic activity observed and the consistency in response between the Phase 2 and Phase 3 trials, the Phase 3 DOM-INNATE study could serve as the first of two Phase 3 studies required to support potential marketing authorization, assuming the second Phase 3 clinical trial achieves the required level of statistical significance in its primary endpoint. With the benefit of a robust preclinical and clinical data package for SGX942, we now will analyze the data to design a second Phase 3 study and will look to identify a potential partner(s) to continue this development program.
In January 2022, dusquetide proved effective at reducing tumor size in nonclinical xenograft models. Recent studies, recapitulating results from previously published studies, have confirmed the efficacy of dusquetide as a treatment for severestand-alone and combination anti-tumor therapy, with radiation, chemotherapy and targeted therapy, in the context of the MCF-7 breast cancer cell line. Of note, these results are consistent with a potential direct anti-tumor effect identified with SGX942 and is another important consideration in the oral mucositis treatment space.
In June 2022, an article was published describing the binding of our IDR, dusquetide, to the p62 protein. Dusquetide binds to p62 or SQSTM-1, a scaffold protein implicated in patientsa number of intracellular signaling networks implicated in tumor cell survival, including autophagy. This publication elaborates on the direct interaction of dusquetide with headp62, as well as some of the direct downstream consequences of that interaction, consistent with its observed anti-infective, anti-tumor and neck cancer receiving CRT.anti-inflammatory activities. This information advances the understanding of dusquetide's novel mechanism of action and supports the development of analogs related to dusquetide.
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We estimate the potential worldwide market for SGX942 is in excess of $500 million for all applications, including the treatment of oral mucositis. This potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.
Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. We estimate, based upon our review of historic studies and reports, and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the U.S. per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The GI damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.
The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.
We estimate, based upon our review of historic studies and reports, and an interpolation of data on the incidence of oral mucositis, that oral mucositis is a subpopulation of approximately 90,000 patients in the U.S., with a comparable number in Europe. Oral mucositis almost always occurs in patients with head and neck cancer treated with radiation therapy (greater than 80% incidence of severe mucositis) and is common in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.
SGX945 – for Treating Aphthous Ulcers in Behçet’s Disease
Oral BDPSGX945 is our product candidate containing our IDR technology, dusquetide, targeting the treatment of aphthous Ulcers in Behçet’s Disease. Behçet’s Disease is an orphan disease and an area of unmet medical need.
Oral BDP (beclomethasone 17,21-dipropionate) representsIn November 2023, the FDA cleared the IND application for a first-Phase 2a clinical trial entitled, “Pilot Study of-its-kind oral, locally acting therapy tailored to treat GI inflammation. BDP has been marketed SGX945 (Dusquetide) in the U.S.Treatment of Aphthous Ulcers in Behçet’s Disease.” The study is designed to evaluate the safety and worldwide sincepotential efficacy of SGX945 (dusquetide) in the early 1970s asresolution of aphthous flares in Behçet’s Disease and is expected to begin patient enrollment in the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhalersecond half of 2024.
In January 2024, SGX945 received Fast Track designation for the treatment of patients with allergic rhinitis and asthma. Oral BDP is specifically formulated for oral administration aslesions of Behçet’s Disease from the FDA.
In February 2024, we announced the formation of a single product consistingMedical Advisory Board to provide medical/clinical strategic guidance to advance the clinical development of two tablets. One tablet is intended to release BDP in the upper sections of the GI tract and the other tablet is intended to release BDP in the lower sections of the GI tract.
Based on its pharmacological characteristics, oral BDP may have utility in treating other conditions of the gastrointestinal tract having an inflammatory component. We are planning to pursue development programsSGX945 for the treatment of pediatric Crohn’s disease, acute radiation enteritis and GI ARS pending further grant funding. We are also exploring the possibility of testing oral BDP for local inflammation associated with ulcerative colitis, among other indications.
Behçet's Disease.
We estimate the potential worldwide market for oral BDPSGX945 is in excess of $500$200 million for all applications, including the treatment of pediatric Crohn’s disease.aphthous ulcers in Behçet’s Disease. This potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.
Behçet’s Disease
SGX203 – for Treating Pediatric Crohn’sBehçet’s Disease
SGX203 (“BD”) is commonly known as an inflammatory disorder of the blood vessels (vasculitis). Often first diagnosed in young adults, its effects and severity will wax and wane over time. Major signs and symptoms usually include mouth sores (approximately 95% of patients), skin rashes and lesions (approximately 50% of patients), genital sores (approximately 50% of patients), leg ulcers (approximately 40% of patients) and eye inflammation (approximately 15% of patients). It is a two tablet delivery systempainful disease, directly impacting the patient’s quality of BDP specifically designed for oral use that allows for administrationlife and ability to productively engage in life activities, including work.
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BD is thought to be an auto-immune disease with both genetic and delayed release BDP throughout the small bowel and the colon. The FDA has given SGX203 Orphan Drug designation as well as Fast Track designation for the treatment of pediatric Crohn’s disease. We will pursue a pivotal Phase 3 clinical trial of SGX203 for the treatment of pediatric Crohn’s disease contingent upon additional funding, such as through partnership funding support.
Pediatric Crohn’s Disease
Crohn’s disease causes inflammation of the GI tract. Crohn’s disease can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine, called the ileum. The swelling caused by the disease extends deep into the lining of the affected organ. The swelling can induce pain and can make the intestines empty frequently, resulting in diarrhea. Because the symptoms of Crohn’s disease are similar to other intestinal disorders, such as irritable bowel syndrome and ulcerative colitis, it can be difficult to diagnose. People of Ashkenazi Jewish heritage have an increased risk of developing Crohn’s disease.
Crohn’s disease can appear at any age, but itenvironmental factors. It is most often diagnosedcommon along the “silk road” in adults in their 20sthe Middle East and 30s. However,East Asia, including Turkey, Iran, Japan and China. There are approximately 30%18,000 known cases of people with Crohn’s disease develop symptoms before 20 years of age. We estimate, based upon our review of historic published studies and reports, and an interpolation of data on the incidence of pediatric Crohn’s disease, that pediatric Crohn’s disease is a subpopulation of approximately 80,000 patientsBD in the U.S. and 80,000 in Europe. There are as many as 1,000,000 people worldwide living with BD.
There is no cure for BD, rather treatments are prescribed to manage symptoms. Treatments may include both maintenance therapies and those specifically addressing mucocutaneous flares (e.g., mouth ulcers, genital ulcers and leg ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side effects that become more concerning with more chronic use. Genital ulcers are often associated with significant genital scarring while leg ulcers can result in a post-thrombotic syndrome. Other treatments for BD flares involve suppressing the immune system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a comparable numberhigher risk of infection, liver and kidney problems, low blood counts and high blood pressure. Finally, anti-inflammatory drugs are also used, including anti-TNF medications. The only approved drug in Europe. Crohn’s disease tendsBD is apremilast, which is used as a maintenance therapy to beprevent formation of oral ulcers. Unfortunately, apremilast is associated with both severehigh cost and extensive in the pediatric population and a relatively high proportion (approximately 40%) of pediatric Crohn’s patients have involvement of their upper gastrointestinal tract.
Crohn’s disease presents special challenges for children and teens. In addition to bothersome and often painful symptoms, the disease can stunt growth, delay puberty, and weaken bones. Crohn’s disease symptoms may sometimes prevent a child from participating in enjoyable activities. The emotional and psychological issues of living with a chronic disease can be especially difficult for young people.
SGX201 – for Preventing Acute Radiation Enteritis
SGX201 is a delayed-release formulation of BDP specifically designed for oral use. In 2012, we completed a Phase 1/2 clinical trial testing SGX201 in prevention of acute radiation enteritis. Patients with rectal cancer scheduled to undergo concurrent radiation and chemotherapy prior to surgery were randomized to one of four dose groups. The objectives of the study were to evaluate the safety and maximal tolerated dose of escalating doses of SGX201, as well as the preliminary efficacy of SGX201 for prevention of signs and symptoms of acute radiation enteritis. The study demonstrated that oral administration of SGX201 was safe and well tolerated across all four dose groups. There was also evidence of a potential dose response with respect toside effects including diarrhea, nausea, upper respiratory tract infection and vomiting and the assessment of enteritis according to National Cancer Institute Common Terminology Criteria for Adverse Events for selected gastrointestinal events. In addition, the incidence of diarrhea was lower than that seen in recent published historical control data in this patient population. This program was supported in part by a $500,000 two-year SBIR grant awarded by the NIH. We continue to work with our Radiation Enteritis medical advisors to identify additional funding opportunities to support the clinical development program.headache.
We have received Fast Track designation from the FDA for SGX201 for acute radiation enteritis.
Acute Radiation Enteritis
External radiation therapy is used to treat most types of cancer, including cancer of the bladder, uterine, cervix, rectum, prostate, and vagina. During delivery of treatment, some level of radiation will also be delivered to healthy tissue, including the bowel, leading to acute and chronic toxicities. The large and small bowels are very sensitive to radiation and the larger the dose of radiation the greater the damage to normal bowel tissue. Radiation enteritis is a condition in which the lining of the bowel becomes swollen and inflamed during or after radiation therapy to the abdomen, pelvis, or rectum. Most tumors in the abdomen and pelvis need large doses, and almost all patients receiving radiation to the abdomen, pelvis, or rectum will show signs of acute enteritis.
Patients with acute enteritis may have nausea, vomiting, abdominal pain and bleeding, among other symptoms. Some patients may develop dehydration and require hospitalization. With diarrhea, the gastrointestinal tract does not function normally, and nutrients such as fat, lactose, bile salts, and vitamin B12 are not well absorbed.
Symptoms will usually resolve within two to six weeks after therapy has ceased. Radiation enteritis is often not a self-limited illness, as over 80% of patients who receive abdominal radiation therapy complain of a persistent change in bowel habits. Moreover, acute radiation injury increases the risk of development of chronic radiation enteropathy, and overall 5% to 15% of the patients who receive abdominal or pelvic irradiation will develop chronic radiation enteritis.
We estimate, based upon our review of historic published studies and reports, and an interpolation of data on the treatment courses and incidence of cancers occurring in the abdominal and pelvic regions, there to be over 100,000 patients annually in the U.S., with a comparable number in Europe, who receive abdominal or pelvic external beam radiation treatment for cancer, and these patients are at risk of developing acute and chronic radiation enteritis.
Vaccines/BioDefensePublic Health Solutions Overview
ThermoVax®– Thermostability Platform Technology
Our thermostability technology, ThermoVax®, is a novel method for thermostabilizing vaccines with a variety of renderingadjuvants, resulting in a single vial which can be reconstituted with water for injection immediately prior to use. One of the adjuvants utilized in ThermoVax® is aluminum salt,salts (known colloquially as Alum), adjuvanted vaccines stable at elevated temperatures.“Alum”). Alum is the most widely employed adjuvant technology in the vaccine industry.
The value of ThermoVax® lies in its potential ability to eliminate the need for cold chain production, transportation, and storage for Alum adjuvantedAlum-adjuvanted vaccines. This would relieve companies of the high costs of producing and maintaining vaccines under refrigerated conditions. Based on historical reports from the World Health OrganizationWHO and other scientific reports, we believe that a meaningful proportion of vaccine doses globally are wasted due to excursions from required cold chain temperature ranges. This is due to the fact that most Alum adjuvantedmany vaccines need to be maintained ateither between 2 and 8 degrees Celsius (“C”), frozen below -20 degrees C, or frozen below -60 degrees C, and even brief excursions from thisthese temperature range (especially below freezing)ranges usually necessitatesnecessitate the destruction of the product or the initiation of costly stability programs specific for the vaccine lots in question. We believe that the savings realized from the elimination of cold chain costs and related product losses would significantly increase the profitability of vaccine products. We believe that elimination of the cold chain could further facilitate the use of these vaccines in the lesser developed parts of the world. ThermoVax® has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines for ricin exposure in emergency settings.
ThermoVax®development, specifically in the context of an Alum adjuvant, was supported pursuant to our $9.4 million NIAID grant enabling development of thermo-stable ricin (RiVax®) and anthrax (VeloThrax®) vaccines. Proof-of-concept preclinical studies with ThermoVax® indicate that it is able to produce stable vaccine formulations using adjuvants, protein immunogens, and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions. These studies were conducted with our aluminum-adjuvantedAlum-adjuvanted ricin toxin vaccine, RiVax® and our aluminum-adjuvantedAlum-adjuvanted anthrax vaccine, VeloThrax®.vaccine. Each vaccine was manufactured under precise lyophilization conditions using excipients that aid in maintaining native protein structure of the key antigen. When RiVax® was kept at 40 degrees C (104 degrees Fahrenheit)Fahrenheit (“F”)) for up to one year, all of the animals vaccinated with the lyophilized RiVax® vaccine developed potent and high titer neutralizing antibodies. In contrast, animals that were vaccinated with the liquid RiVax® vaccine kept at 40 degrees C did not develop neutralizing antibodies and were not protected against ricin exposure. The ricin A chain is extremely sensitive to temperature and rapidly loses the ability to induce neutralizing antibodies when exposed to temperatures higher than 8 degrees C. When VeloThrax®the anthrax vaccine was kept for up to 16 weeks at 70 degrees C, it was able to develop a potent antibody response, unlike the liquid formulation kept at the same temperature. Moreover, we also have demonstrated the compatibility of our thermostabilization technology with other secondary adjuvants such as TLR-4 agonists. Additionally, the University of Colorado conducted a study that demonstrated a heat stable vaccine formulation of a human papillomavirus (“HPV”) vaccine. The work was conducted by Drs. Randolph and Garcea and demonstrated the successful conversion of a commercial virus-like-particle based vaccine requiring cold chain storage to a subunit, alum-adjuvanted, vaccine which is stable at ambient temperatures. This work, funded by a University of Colorado seed grant and the Specialized Program of Research Excellence in cervical cancer, is the first demonstration of the utility of ThermoVax® technology for the development of a subunit based commercial vaccine. The HPV vaccine formulation was found to be stable for at least 12 weeks at 50 degrees C. In the study, mice immunized with the ThermoVax®-stabilized HPV subunit vaccine were also found to achieve immune responses similar to the commercial HPV vaccine, Cervarix®, as measured by either total antibody levels or neutralizing antibody levels. Moreover, whereas the immune responses to Cervarix®were reduced after storage for 12 weeks at 50 degrees C, the ThermoVax® formulated vaccine retained its efficacy. The results were published online in the European Journal of Pharmaceutics and Biopharmaceutics. Seehttp://www.sciencedirect.com/science/article/pii/S0939641115002416).
We also entered into a collaboration agreement with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (“JABSOM”), University of HawaiʻiHawai’i at Manoa (“UH Manoa”) and Hawaii Biotech, Inc. (“HBI”) to develop a heat stable subunit Ebola vaccine. Dr. Lehrer, a co-inventor of the Ebola vaccine with HBI, has shown proof of concept efficacy with subunit Ebola vaccines in non-human primates.primates (“NHP”). The most advanced Ebola vaccines involve the use of vesicular stomatitis virus and adenovirus vectors – live, viral vectors which complicate the manufacturing, stability and storage requirements. Dr. Lehrer’s vaccine candidate is based on highly purified recombinant protein antigens, circumventing many of these manufacturing difficulties. Dr. Lehrer and HBI have developed a robust manufacturing process for the required proteins. Application of ThermoVax® may allow for a product
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that can avoid the need for cold chain distribution and storage, yielding a vaccine ideal for use in both the developed and developing world. Although thisThis agreement has expired in accordance with its terms,terms.
In December 2010, we expectexecuted a worldwide exclusive license agreement with the University of Colorado (“UC”) for certain patents relating to ThermoVax® in all fields of use. In April 2018, the UC delivered a notice of termination of our license agreement based upon our failure to achieve one of the development milestones: initiation of the Phase 1 clinical trial of the heat stabilization technology by March 31, 2018. After negotiating with the UC, we and the UC agreed to extend the periodtermination date to October 31, 2018 in order to allow us time to agree upon a potential agreement that would allow us to keep the rights to, and to continue to develop, the heat stabilization technology or a product candidate containing the heat stabilization technology in our field of the agreement or enter into another agreement with Dr. Lehrer and HBI to replace this agreement.
use.
During September 2017, we announced we will be participating inwere awarded funding of approximately $700,000 over five years under a NIAID Research Project (R01) grant awarded to UH Manoa for the development of a trivalent thermostabilized Ebolafilovirus vaccine with our awarded funding of approximately $700,000 over five years.(including protection against Zaire ebolavirus, Sudan ebolavirus and Marburg Marburgvirus). Previous collaborations demonstrated the feasibility of developing a heat stable subunit Ebola vaccine. Under the terms of the subaward, we will continue to support vaccine formulation development with our proprietary vaccine thermostabilization technology, ThermoVax®. Ultimately, the objective is to produce a thermostable trivalent filovirus vaccine for protection against Ebola and related diseases, allowing worldwide distribution without the need for cold storage. Based on current U.S. government needs, efforts have been expanded to focus on a monovalent or bivalent vaccine to specifically address Marburg marburgvirus.
In October 2018, in a series of related transactions, (a) we and the UC agreed to terminate the original license agreement, (b) the UC and VitriVax, Inc. (“VitriVax”) executed a worldwide exclusive license agreement for the heat stabilization technology for all fields of use, and (c) we and VitriVax executed a worldwide exclusive sublicense agreement, which was amended and restated in October 2020, for the heat stabilization technology for use in the fields of ricin and Ebola vaccines. We paid a $100,000 sublicense fee on the effective date of the sublicense agreement. Under the amended sublicense agreement to maintain the sublicense we are obliged to pay a minimum annual royalty of $20,000 until first commercial sale of a sublicensed product, upon which point, we shall pay an earned royalty of 2% of net sales subject to a minimum royalty of $50,000 each year. We are also required to pay royalty on any sub-sublicense income based on a declining percentage of all sub-sublicense income calculated within the contractual period until reaching a minimum of 15% after two years. In addition, we are required to pay VitriVax milestone fees of: (a) $25,000 upon initiation of a Phase 2 clinical trial of the sublicensed product, (b) $100,000 upon initiation of a Phase 3 clinical trial of the sublicensed product, (c) $100,000 upon regulatory approval of a sublicensed product, and (d) $1 million upon achieving $10 million in aggregate net sales of a sublicensed product in the U.S. or equivalent. To date none of these milestones have been met.
We intendIn March 2020, we entered into a research collaboration with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UH Manoa to seek outfurther expand the filovirus collaboration to investigation of potential partnerships with companies marketing FDA/ex-U.S. health authority approved Alum adjuvantedcoronavirus vaccines, including for SARS-CoV-2 (causing COVID-19). This research collaboration will utilize the technology platform developed in the search for filovirus vaccines and currently developing Alum adjuvanted vaccines thatwill use well-defined surface glycoprotein(s) from one or more coronaviruses, which are interestedexpected to be protective for COVID-19.
During April 2020, we obtained an exclusive worldwide license for CoVaccine HT™, a novel vaccine adjuvant, from SERB Pharmaceuticals (formerly BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation) (“SERB”), for the fields of coronavirus infection (including SARS-CoV-2, the cause of COVID-19), and pandemic flu. CoVaccine HT™ is a novel adjuvant, which has been shown to enhance both cell-mediated and antibody-mediated immunity. We and our collaborators, including UH Manoa and Dr. Axel Lehrer, have successfully demonstrated the utility of CoVaccine HT™ in eliminating the need for cold chain for their products. We believe that ThermoVax® also will enable us to expand our vaccine development expertise beyond biodefense into the infectious disease space and also has the potential to allow for the development of our heat stable filovirus vaccine program, with vaccine candidates against Ebola and Marburg virus disease. Given this previous success, CoVaccine HT™ will potentially be an important component of our vaccine technology platform currently being assessed for use against coronaviruses including SARS-CoV-2, the cause of COVID-19. The license agreement was executed between us and SERB, which owns the CoVaccine HT™ intellectual property.
In September 2020, the Journal of Pharmaceutical Sciences published a scientific article detailing the thermostabilization of the filovirus GP proteins and key assays describing their stability.
During October 2020, Frontiers in Immunology published a scientific article describing CiVax™, a prototype COVID-19 vaccine, using the novel CoVaccine HT™ adjuvant and demonstrating significant immunogenicity, including strong total and neutralizing antibody responses, with a balanced Th1 response, as well as enhancement of cell mediated immunity. These are all considered to be critical attributes of a potential COVID-19 vaccine.
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In December 2020, NIAID awarded us a Direct to Phase II Small Business Innovation Research (“SBIR”) grant of approximately $1.5 million to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 and Ebola Virus Disease (“EVD”) vaccine candidates in conjunction with the CoVaccine HT™ adjuvant. This award also is supporting immune characterization of this novel, emulsified adjuvant that has unique potency and compatibility with lyophilization strategies to enable thermostabilization of subunit vaccines.
During August 2021, positive data demonstrated the efficacy of multiple filovirus vaccine candidates in NHP, including thermostabilized multivalent vaccines (e.g.in a single vial platform presentation. Collaborators at UH Manoa describe the potent efficacy of vaccine candidates protecting against three life-threatening filoviruses, Zaire ebolavirus, combination ricin-anthrax vaccine).Sudan ebolavirus and Marburg Marburgvirus in an article titled "Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques from Ebola, Sudan, and Marburg Viruses", published in Frontiers in Immunology. These vaccine candidates contain highly purified protein antigens combined with the novel CoVaccine HT™ adjuvant, in both monovalent (single antigen) and bivalent (two antigen) formulations. Most recently, efforts to formulate all three antigens and adjuvant into a thermostable single-vial vaccine platform has also been shown to protect 75% of vaccinated NHPs against subsequent Sudan ebolavirus challenge, with further development to test efficacy against other filovirus infections ongoing.
During August 2021, Vaccine published a scientific article describing the formulation of single-vial platform presentations of monovalent (single antigen), bivalent (two antigens) and trivalent (three antigens) combinations of filovirus vaccine candidates.
During September 2021, an accelerated preprint was posted on bioRxiv of pre-clinical immunogenicity studies for CiVax™ (heat stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing antibody responses, including against the Beta, Gamma and Delta variants of concern. The scientific article was subsequently published on March 9, 2022 in ACS Infectious Diseases. The work is part of an ongoing collaboration with Axel Lehrer, PhD, Associate Professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UH Manoa. Development continues under a non-dilutive $1.5M grant from the NIAID awarded to us in December 2020.
In December 2021, 100% protection of NHPs against lethal Sudan ebolavirus challenge was achieved using a bivalent, thermostabilized vaccine formulated in a single vial, reconstituted only with water immediately prior to use. This milestone is part of an ongoing collaboration with UH Manoa and further demonstrates the broad applicability of the vaccine platform, and its potential role in the U.S. government's initiative for pandemic preparedness.
In May 2022, the U.S. Patent and Trademark Office issued a Notice of Allowance for the patent application titled “Composition and Methods of Manufacturing Trivalent Filovirus Vaccines.” The allowed claims are directed to unique, proprietary composition and methods directed to combinations of glycoprotein antigens with nano-emulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization. The described vaccine platform has previously been successfully applied to filovirus vaccines (as mono-, bi- and tri-valent candidates for Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus) as well as SARS-CoV-2 vaccine. No currently licensed lyophilized vaccine that contains an adjuvant is presented in a single vial format and there are few reports of successfully using nano-emulsions in lyophilized formulations. Previous work has demonstrated the use of a single vial platform to co-lyophilize antigen(s) and a nano-emulsion adjuvant, CoVaccine HT™, maintaining key adjuvant stability characteristics including particle size and colloidal stability, as well as maintaining immunogenicity. This most recent milestone confirms that, in the context of lethal challenge with Sudan ebolavirus, complete protection is maintained with the thermostabilized formulation.
In June 2022, 100% protection of NHPs against lethal Marburg marburgvirus challenge was achieved using a bivalent, thermostabilized vaccine formulated in a single vial, reconstituted only with sterile water immediately prior to use. This important milestone is part of an ongoing collaboration with UH Manoa, demonstrating the successful presentation of one or more antigen(s) within the same formulation while maintaining full potency and thermostability. It further demonstrates the broad applicability of the heat stable vaccine platform, and its potential role in the U.S. government's initiative for pandemic preparedness.
In September 2023, positive data demonstrated two-year stability of thermostabilized bivalent and trivalent filovirus vaccine candidates at temperatures of 40 degrees C (104 degrees F) when formulated in a single vial, needing reconstitution only with sterile water immediately prior to use. This important milestone is part of an ongoing collaboration with UH Manoa, demonstrating the successful presentation of one or more antigen(s) within the same formulation while maintaining full potency and thermostability. It further demonstrates the broad applicability of the heat stable vaccine platform, and its potential role in the U.S. government’s initiative for pandemic preparedness.
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In January 2024, Vaccine published the preclinical efficacy results of our novel, single-vial, thermostabilized bivalent filovirus vaccine providing 100% protection against both Sudan ebolavirus (SUDV) and Marburg marburgvirus (MARV) infections. The manuscript was entitled “Thermostable bivalent filovirus vaccine protects against severe and lethal Sudan ebolavirus and marburgvirus infection”.
RiVax® – for Protection Against Ricin Toxin Vaccine
Exposure
RiVax®is our proprietary vaccine candidate being developed to protect against exposure to ricin toxin and if approved, would be the first ricin vaccine. The immunogen in RiVax® induces a protective immune response in animal models of ricin exposure and functionally active antibodies in humans. The immunogen consists of a genetically inactivated ricin A chain subunit that is enzymatically inactive and lacks residual toxicity of the holotoxin. RiVax® has demonstrated statistically significant (p < 0.0001) preclinical survival results, providing 100% protection against acute lethality in an aerosol exposure non-human primate model (Roy et al, 2015, Thermostable ricin vaccine protects rhesus macaques against aerosolized ricin: Epitope-specific neutralizing antibodies correlate with protection, PNAS USA 112:3782-3787), and has also been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Results of the first Phase 1 human trial of RiVax® established that the immunogen was safe and induced antibodies that we believe may protect humans from ricin exposure. The antibodies generated from vaccination, concentrated and purified, were capable of conferring immunity passively to recipient animals, indicating that the vaccine was capable of inducing functionally active antibodies in humans. The outcome of this study was published in the Proceedings of the National Academy of Sciences (Vitetta et al., 2006, A Pilot Clinical Trial of a Recombinant Ricin Vaccine in Normal Humans, PNAS, 103:2268-2273). The second trial whichthat was completed in September 2012 and was sponsored by University of Texas Southwestern Medical Center (“UTSW”), evaluated a more potent formulation of RiVax® that contained an aluminum adjuvant (Alum).Alum adjuvant. The results of the Phase 1b study indicated that Alum-adjuvanted RiVax® was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax®. The outcomes of this second study were published in the Clinical and Vaccine Immunology (Vitetta et al., 2012, Recombinant Ricin Vaccine Phase 1b Clinical Trial, Clin. Vaccine Immunol. 10:1697-1699). Immunology.
We have adapted the original manufacturing process for the immunogen contained in RiVax® for thermostability and large scale manufacturing and recent studies have confirmed that the thermostabilized RiVax® formulation enhances the stability of the RiVax® antigen, enabling storage for at least 1 year at temperatures up to 40°40 degrees C (104 °F)degrees F). The program will pursue approval via the FDA “Animal Rule” since it is not possible to test the efficacy of the vaccine in a clinical study which would expose humans to ricin. Uniform, easily measured and species-neutral immune correlates of protection that can be measured in humans and animals, and are indicative of animal survival to subsequent ricin challenge, are central to the application of the “Animal Rule”.Rule.” Recent work has identified such potential correlates of immune protection in animals and work to qualify and validate these approaches is continuing, with the goal of utilizing these assays in a planned Phase 1/2 clinical trial with the thermostable RiVax® formulation. During September 2018, we published an extended stability study of RiVax®, showing up to 100% protection in mice after 12 months storage at 40 degrees C (104 degrees F) as well as identification of a potential in vitro stability indicating assay, critical to adequately confirming the long-term shelf life of the vaccine. We have entered into a collaboration with IDT Biologika GmbH (“IDT”) to scale-up the formulation/filling process and continue development and validation of analytical methods established at IDT to advance the program. We also have initiated a development agreement with Emergent BioSolutions, Inc. (“EBS”) to implement a commercially viable, scalable production technology for the RiVax® drug substance protein antigen.
The development of RiVax® has been sponsored through a series of overlapping challenge grants, UC1, and cooperative grants, U01, from the NIH, granted to us and to UTSW where the vaccine originated. The second clinical trial was supported by a grant from the FDA’s Office of Orphan Products to UTSW. To date, we and UTSW have collectively received approximately $25 million in grant funding from the NIH for the development of RiVax®. In September 2014, we entered into a contract with the NIH for the development of RiVax® that would provide uppursuant to which we were awarded an additional $24.7$21.2 million of funding in the aggregate if options to extend the contract are exercised by the NIH.aggregate. The development agreements with Emergent BioSolutionsEBS and IDT arewere specifically funded under this NIH contract.
During JuneIn 2017, NIAID exercised an option for the evaluation of RiVax®options to fund additional animal efficacy studies. The exercised option will provide us with approximately $2.0 million in additional funding. Additionally, during August 2017 NIAID exercised an option to fundstudies and good manufacturing practices compliant RiVax®bulk drug substance and finished drug product manufacturing, which is required for the conduct of future preclinical and clinical safety and efficacy studies. The exercised option willoptions provide us with approximately $2.5$4.5 million in additional non-dilutive funding, bringing the total amount awarded to date under this contract to $21.2 million, of which $17.2 million is still available. If all contract options are exercised, theexpired in February 2021. The total award of up to $24.7$21.2 million will supportsupported the preclinical, manufacturing and clinical development activities necessary to advance heat stable RiVax® with the FDA. In addition to the ongoingthis funding of up to $24.7 million for the development of RiVax®, biomarkers for RiVax®testing have been successfully identified, facilitating potential approval under the FDA Animal Rule.
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During December 2019, we initiated a third Phase 1 double-blind, placebo-controlled, randomized study in eight healthy adult volunteer subjects designed to evaluate the safety and immunogenicity of RiVax® utilizing ThermoVax®. During January 2020, we suspended the study after Emergent Manufacturing Operations Baltimore LLC (“EMOB”), the manufacturer of the drug substance, notified us that, after releasing the final drug product to us, EMOB identified that the active drug substance tested outside the established specification parameters. Two subjects had received doses as part of the study before the manufacturer provided this notice. Those two subjects were monitored with no safety issues noted and data was captured in accordance with the study protocol. They did not receive further doses of study drug.
During April 2020, we received notification from NIAID that they would not be exercising the final contract option to support the conduct of a Phase 1/2 clinical study in healthy volunteers. As a result, the total contract award will not exceed $21.2 million. This contract expired in February 2021.
In November 2021, an article was published on pre-clinical immunogenicity studies for RiVax® demonstrating enduring protection for at least 12 months post-vaccination. These results, coupled with the previous demonstration of efficacy in mice and NHPs as well as long-term thermostability (at least 1 year at 40 degrees C or 104 degrees F), reinforce the practicality of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities that arise for vaccines that require stringent cold chain handling.
RiVax®has been granted Orphan Drug designation as well as Fast Track designation by the FDA for the prevention of ricin intoxication.
In addition, RiVax® has also been granted Orphan Drug designation in the European Union (“EU”) from the EMA Committee for Orphan Medical Products.
Assuming development efforts are successful for RiVax®, we believe potential government procurement contract(s) could reach as much as $200 million. This potential procurement contract information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential procurement contract value based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.
As a new chemical entity, an FDA approved RiVax® vaccine has the potential to qualify for a biodefense Priority Review Voucher (“PRV”). Approved under the 21st Century Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context. PRVs are transferable and can be sold, with sales in recent years of up to $350approximately $100 million. When redeemed, PRVs entitle the user to an accelerated review period of nine months, saving a median of seven months review time as calculated in 2009. However, FDA must be advised 90 days in advance of the use of the PRV and the use of a PRV is associated with an additional user fee ($2.71.5 million in 2017)for fiscal year 2023).
In July 2022, we signed a worldwide exclusive agreement to license and supply our ricin antigen, used in our RiVax® vaccine, to SERB, for development of a novel therapeutic treatment against ricin toxin poisoning. In pursuit of a ricin antidote, SERB will leverage its unique broad-spectrum polyclonal antibody platform, gained in its acquisition of BTG Specialty Pharmaceuticals. This specialized manufacturing process generates binding fragments from antibodies that are specific to a given antigen, helping to ensure potency and purity. This platform is currently used to manufacture two of SERB’s currently marketed products, CroFab® and DigiFab®.
In December 2022, we published a paper demonstrating statistically significant correlates of protection predicting survival after lethal aerosolized ricin challenge in non-human primates. The article titled “Serum antibody profiling identifies vaccine-induced correlates of protection against aerosolized ricin toxin in rhesus macaques” was published in the journal npj Vaccines.
Ricin Toxin
Ricin toxin can be cheaply and easily produced, is stable over long periods of time, is toxic by several routes of exposure and thus has the potential to be used as a biological weapon against military and/or civilian targets. As a bioterrorism agent, ricin could be disseminated as an aerosol, by injection, or as a food supply contaminant. The potential use of ricin toxin as a biological weapon of mass destruction has been highlighted in a Federal Bureau of Investigation Bioterror report released in November 2007 titled Terrorism 2002-2005, which states that “Ricin and the bacterial agent anthrax are emerging as the most prevalent agents involved in WMD investigations” (http://www.fbi.gov/stats-services/publications/terrorism-2002-2005/terror02_05.pdf). In recent years,investigations.” Al Qaeda in the Arabian Peninsula hashad threatened the use of ricin toxin to poison food and water supplies and in connection with explosive devices. Domestically, the threat from ricin remains
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a concern for security agencies. As recently asIn April 2013, letters addressed to the U.S. President, of the United States, a U.S. Senator and a judge tested positive for ricin.
As recently as September 2020, ricin-laced letters addressed to the White House and others addressed to Texas law enforcement agencies were intercepted before delivery raising fresh concerns about the deadly toxin.
The Centers for Disease Control and Prevention has classified ricin toxin as a Category B biological agent. Ricin works by first binding to glycoproteins found on the exterior of a cell, and then entering the cell and inhibiting protein synthesis leading to cell death. Once exposed to ricin toxin, there is no effective therapy available to reverse the course of the toxin. The recent ricin threat to government officials has heightened the awareness of this toxic threat. Currently, there is no FDA approved vaccine to protect against the possibility of ricin toxin being used in a terrorist attack, or its use as a weapon on the battlefield nor is there a known antidote for ricin toxin exposure.
OrbeShield® – for Treating GI Acute Radiation Syndrome
OrbeShield®is an oral immediate and delayed release formulation of the topically active corticosteroid BDP and is being developed for the treatment of GI ARS. Corticosteroids are a widely used class of anti-inflammatory drugs. BDP is a corticosteroid with predominantly topical activity that is approved for use in asthma, psoriasis and allergic rhinitis.
OrbeShield®has demonstrated positive preclinical results in a canine GI ARS model which indicate that dogs treated with OrbeShield®demonstrated statistically significant (p=0.04) improvement in survival with dosing at either two hours or 24 hours after exposure to lethal doses of total body irradiation (“TBI”) when compared to control dogs. OrbeShield® appears to significantly mitigate the damage to the GI epithelium caused by exposure to high doses of radiation using a well-established canine model of GI ARS.
The GI tract is highly sensitive to ionizing radiation and the destruction of epithelial tissue is one of the first effects of radiation exposure. The rapid loss of epithelial cells leads to inflammation and infection that are often the primary cause of death in acute radiation injury. This concept of GI damage also applies to the clinical setting of oncology, where high doses of radiation cannot be administered effectively to the abdomen because radiation is very toxic to the intestines. We are seeking to treat the same type of toxicity in our acute radiation enteritis clinical program with SGX201. As a result, we believe that OrbeShield®has the potential to be a “dual use” compound, a desirable characteristic which is a specific priority for ARS and other medical countermeasure indications.
In September 2013, we received two government contracts from BARDA and NIAID for the advanced preclinical and manufacturing development of OrbeShield®leading to FDA approval to treat GI ARS. The BARDA contract contained a two year base period with two contract options, exercisable by BARDA, for a total of five years and up to $26.3 million. The NIAID contract consisted of a one year base period and two contract options, exercisable by NIAID, for a total of three years and up to $6.4 million. We received a combined approximate $18 million in contract funding from both BARDA and NIAID which includes combined supplemental funding of $634,000, extending the programs through the first quarter of 2017. The NIAID contract was completed during the first quarter of 2017 along with the expiration of the base period of the BARDA contract for the development of OrbeShield®, with BARDA electing not to extend the current contract beyond the base period. We will continue to apply for additional government funding. Previously, development of OrbeShield® had been largely supported by a $1 million NIH grant to our academic partner, the Fred Hutchinson Cancer Research Center. In July 2012, we received an SBIR grant from NIAID of approximately $600,000 to support further preclinical development of OrbeShield® for the treatment of acute GI ARS. The FDA has given OrbeShield® Orphan Drug designation and Fast Track designation for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.
Assuming development efforts are successful for OrbeShield®, we believe potential government procurement contracts could reach as much as $450 million. This potential procurement contract information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential procurement contract value based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.
GI Acute Radiation Syndrome
ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the GI tract and later the lungs. In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to greater than 2 grays (“Gy”) of absorbed radiation are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death. The GI tract is highly sensitive due to the continuous need for crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI. Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. As a result, we believe there is an urgent medical need for specific medical counter measures against the lethal pathophysiological manifestations of radiation-induced GI injury.
SGX943 – for Treating Emerging and/or Antibiotic-Resistant Infectious Diseases
SGX943 is an IDR, containing the same active ingredient as SGX942. Dusquetide is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability. Extensivein vivo preclinical studies have demonstrated enhanced clearance of bacterial infection with SGX943 administration. SGX943 has shown efficacy against both Gram-negative and Gram-positive bacterial infections in preclinical models, independent of whether the bacteria is antibiotic-resistant or antibiotic-sensitive.
The innate immune system is responsible for rapid and non-specific responses to combat bacterial infection. Augmenting these responses represents an alternative approach to treating bacterial infections. In animal models, IDRs are efficacious against both antibiotic-sensitive and antibiotic-resistant infections, both Gram-positive and Gram-negative bacteria, and are active irrespective of whether the bacteria occupiesoccupy a primarily extracellular or intracellular niche. IDRs are also effective as stand-alone agents or in conjunction with antibiotics. An IDR for the treatment of serious bacterial infections encompasses a number of clinical advantages including:
| ● | Treatment when antibiotics are contraindicated, such as: | |
o | before the infectious organism and/or its antibiotic susceptibility is known; or | ||
o | in at-risk populations prior to infection. | ||
| ● | An ability to be used as an additive, complementary treatment with antibiotics, thereby: | |
o | enhancing efficacy of sub-optimal antibiotic regimens (e.g., partially antibiotic-resistant infections); | ||
o | enhancing clearance of infection, thereby minimizing the generation of antibiotic resistance (e.g., in treating melioidosis); and | ||
o | reducing the required antibiotic dose, again potentially minimizing the generation of antibiotic resistance. |
| ● | An ability to modulate the deleterious consequences of inflammation in response to the infection, including the inflammation caused by antibiotic-driven bacterial |
| ● | Being unlikely to generate bacterial resistance since the IDR acts on the host, and not the pathogen. |
Importantly, systemic inflammation and multi-organ failure is the ultimate common outcome of not only emerging and/or antibiotic-resistant infectious diseases, but also of most biothreat agents (e.g.,Burkholderia pseudomallei), indicating that dusquetide would be applicable not only to antibiotic-resistant infection, but also to biothreat agents, especially where the pathogen is not known and/or has been engineered for enhanced antibiotic resistance.
In May 2019, we were awarded a DTRA subcontract of approximately $600,000 over three years to participate in a biodefense contract for the development of medical countermeasures against bacterial threat agents. As of December 31, 2023, there was negligible revenue earned or expense incurred related to the DTRA subcontract; the funding for this subcontract has concluded.
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The Drug Approval Process
The FDA and comparable regulatory agencies in state, local and foreign jurisdictions impose substantial requirements on the clinical development, manufacture and marketing of new drug and biologic products. The FDA, through regulations that implement the Federal Food, Drug, and Cosmetic Act, as amended (“FDCA”), and other laws and comparable regulations for other agencies, regulate research and development activities and the testing, manufacture, labeling, storage, shipping, approval, recordkeeping, advertising, promotion, sale, export, import and distribution of such products. The regulatory approval process is generally lengthy, expensive and uncertain. Failure to comply with applicable FDA and other regulatory requirements can result in sanctions being imposed on us or the manufacturers of our products, including holds on clinical research, civil or criminal fines or other penalties, product recalls, or seizures, or total or partial suspension of production or injunctions, refusals to permit products to be imported into or exported out of the United States,U.S., refusals of the FDA to grant approval of drugs or to allow us to enter into government supply contracts, withdrawals of previously approved marketing applications and criminal prosecutions.
Before human clinical testing in the U.S. of a new drug compound or biological product can commence, an Investigational New Drug (“IND”), application is required to be submitted to the FDA. The IND application includes results of pre-clinical animal studies evaluating the safety and efficacy of the drug and a detailed description of the clinical investigations to be undertaken.
Clinical trials are normally done in three phases, although the phases may overlap. Phase 1 trials are smaller trials concerned primarily with metabolism and pharmacologic actions of the drug and with the safety of the product. Phase 2 trials are designed primarily to demonstrate effectiveness and safety in treating the disease or condition for which the product is indicated. These trials typically explore various doses and regimens. Phase 3 trials are expanded clinical trials intended to gather additional information on safety and effectiveness needed to clarify the product’s benefit-risk relationship and generate information for proper labeling of the drug, among other things. The FDA receives reports on the progress of each phase of clinical testing and may require the modification, suspension or termination of clinical trials if an unwarranted risk is presented to patients. When data is required from long-term use of a drug following its approval and initial marketing, the FDA can require Phase 4, or post-marketing, studies to be conducted.
With certain exceptions, once successful clinical testing is completed, the sponsor can submit a New Drug Application (“NDA”),NDA, for approval of a drug, or a Biologic License Application (“BLA”), for biologics such as vaccines, which will be reviewed, and if successful, approved by the FDA, allowing the product to be marketed. The process of completing clinical trials for a new drug is likely to take a number of years and require the expenditure of substantial resources. Furthermore, the FDA or any foreign health authority may not grant an approval on a timely basis, if at all. The FDA may deny the approval of ana NDA or BLA, in its sole discretion, if it determines that its regulatory criteria have not been satisfied or may require additional testing or information. Among the conditions for marketing approval is the requirement that the prospective manufacturer’s quality control and manufacturing procedures conform to good manufacturing practice regulations. In complying with standards contained in these regulations, manufacturers must continue to expend time, money and effort in the area of production, quality control and quality assurance to ensure full technical compliance. Manufacturing facilities, both foreign and domestic, also are subject to inspections by, or under the authority of, the FDA and by other federal, state, local or foreign agencies.
Even after initial FDA or foreign health authority approval has been obtained, further studies, including Phase 4 post-marketing studies, may be required to provide additional data on safety and will be required to gain approval for the marketing of a product as a treatment for clinical indications other than those for which the product was initially tested. For certain drugs intended to treat serious, life-threatening conditions that show great promise in earlier testing, the FDA can also grant conditional approval. However, drug developers are required to study the drug further and verify clinical benefit as part of the conditional approval provision, and the FDA can revoke approval if later testing does not reproduce previous findings. The FDA may also condition approval of a product on the sponsor agreeing to certain mitigation strategies that can limit the unfettered marketing of a drug. Also, the FDA or foreign regulatory authority will require post-marketing reporting to monitor the side effects of the drug. Results of post-marketing programs may limit or expand the further marketing of the product. Further, if there are any modifications to the drug, including any change in indication, manufacturing process, labeling or manufacturing facility, an application seeking approval of such changes will likely be required to be submitted to the FDA or foreign regulatory authority.
In the U.S., the FDCA, the Public Health Service Act, the Federal Trade Commission Act, and other federal and state statutes and regulations govern, or influence the research, testing, manufacture, safety, labeling, storage, record keeping, approval, advertising and promotion of drug, biological, medical device and food products. Noncompliance with applicable
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requirements can result in, among other things, fines, recall or seizure of products, refusal to permit products to be imported into the U.S., refusal of the government to approve product approval applications or to allow the Companyus to enter into government supply contracts, withdrawal of previously approved applications and criminal prosecution. The FDA may also assess civil penalties for violations of the FDCA involving medical devices.
For biodefense development, such as with RiVax® and OrbeShield®, the FDA has instituted policies that are expected to result in shorter pathways to market. This potentially includes approval for commercial use utilizing the results of animal efficacy trials, rather than efficacy trials in humans. However, the Companywe will still have to establish that the vaccine and countermeasures it is developing are safe in humans at doses that are correlated with the beneficial effect in animals. Such clinical trials will also have to be completed in distinct populations that are subject to the countermeasures; for instance, the very young and the very old, and in pregnant women, if the countermeasure is to be licensed for civilian use. Other agencies will have an influence over the benefit-risk scenarios for deploying the countermeasures and in establishing the number of doses utilized in the Strategic National Stockpile. We may not be able to sufficiently demonstrate the animal correlation to the satisfaction of the FDA, as these correlates are difficult to establish and are often unclear. Invocation of the animal rule may raise issues of confidence in the model systems even if the models have been validated. For many of the biological threats, the animal models are not available and the Companywe may have to develop the animal models, a time-consuming research effort. There are few historical precedents, or recent precedents, for the development of new countermeasure for bioterrorism agents. Despite the animal rule, the FDA may require large clinical trials to establish safety and immunogenicity before licensure and it may require safety and immunogenicity trials in additional populations. Approval of biodefense products may be subject to post-marketing studies, and could be restricted in use in only certain populations.
Vaccines are approved under the BLA process that exists under the Public Health Service Act. In addition to the greater technical challenges associated with developing biologics, the potential for generic competition is lower for a BLA product than a small molecule product subject to ana NDA under the Federal Food, Drug and Cosmetic Act. Under the Patient Protection and Affordable Care Act enacted in 2010, a “generic” version of a biologic is known as a biosimilar and the barriers to entry – whether legal, scientific, or logistical – for a biosimilar version of a biologic approved under a BLA are higher.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs or biologics intended to treat a rare disease or condition – generally a disease or condition that affects fewer than 200,000 individuals in the United States.U.S. Orphan drug designation must be requested before submitting ana NDA or BLA. After the FDA grants orphan drug designation, the generic identity of the drug or biologic and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. The first NDA or BLA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the United StatesU.S. for that product, for that indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug or biologic for the same disease, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA or BLA application user fee.
Fast Track Designation and Accelerated Approval
The FDA is required to facilitate the development, and expedite the review, of drugs or biologics that are intended for the treatment of a serious or life-threatening disease or condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for the condition. Under the fast track program, the sponsor of a new drug or biologic candidate may request that the FDA designate the candidate for a specific indication as a fast track drug or biologic concurrent with, or after, the filing of the IND for the candidate. The FDA must determine if the drug or biologic candidate qualifies for fast track designation within 60 days of receipt of the sponsor’s request. Unique to a fast track product, the FDA may initiate review of sections of a fast track product’s NDA or BLA before the application is complete. This rolling review is available if the applicant provides, and the FDA approves, a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA’s time period goal for reviewing an application does not begin until the last section of the NDA or BLA is submitted. Additionally, the fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.
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Any product submitted to the FDA for marketing, including under a fast track program, may be eligible for other types of FDA programs intended to expedite development and review, such as accelerated approval. Drug or biological products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval, which means the FDA may approve the product based upon a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
In clinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that substitutes for a direct measurement of how a patient feels, functions, or survives. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. A drug or biologic candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, will allow the FDA to withdraw the drug or biologic from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA.
Pediatric Information
Under the Pediatric Research Equity Act (“PREA”), NDAs or BLAs or supplements to NDAs or BLAs must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant full or partial waivers, or deferrals, for submission of data. Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation has been granted.
Paediatric Investigation Plan
As part of the regulatory process for the registration of new medicines with the EMA and the MHRA, pharmaceutical companies are required to provide a PIP outlining the Company’s strategy for investigation of the new medicinal products in the paediatric population. In some instances, a waiver negating the need for a PIP for certain conditions may be granted by the EMA or MHRA when development of a medicine for use in children is not feasible or appropriate.
Innovative Licensing and Access Pathway
The ILAP was launched in the UK at the start of 2021 to accelerate the development and access to promising medicines, thereby facilitating patient access to new medicines. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with the MHRA and other stakeholders including the NICE, and the SMC. The decision to award the Innovation Passport is made by an ILAP Steering Group, which is comprised of representatives from MHRA, NICE, and SMC. The Innovation Passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day accelerated assessment, rolling review and a continuous benefit risk assessment.
Early Access to Medicines Scheme
Launched in April 2014 in the United Kingdom by the MHRA, the Early Access to Medicines Scheme (“EAMS”) offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines earlier than they would normally be accessible. PIM designation is the first phase of EAMS and is awarded following an assessment of early nonclinical and clinical data by the MHRA. The criteria product candidates must meet to obtain PIM designation are:
| ● | Criterion 1 – The condition should be life-threatening or seriously debilitating with a high unmet medical need (i.e., there is no method of treatment, diagnosis or prevention available or existing methods have serious limitations). |
| ● | Criterion 2 – The medicinal product is likely to offer major advantage over methods currently used in the UK. |
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| ● | Criterion 3 – The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance. A positive benefit risk balance should be based on preliminary scientific evidence that the safety profile of the medicinal product is likely to be manageable and acceptable in relation to the estimated benefits. |
False Claims Laws
The federal False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to, or approval by, the federal government or knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government.
Anti-Kickback Laws
The federal Anti-Kickback Statute prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term remuneration has been interpreted broadly to include anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, and formulary managers on the other.
United States Healthcare Reform
Federal Physician Payments Sunshine Act and its implementing regulations require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members.
In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. The Health Insurance Portability and Accountability Act (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates” – independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
Third-Party Suppliers and Manufacturers
Drug substance and drug product manufacturing is outsourced to qualified suppliers. We do not have manufacturing capabilities/infrastructure and do not intend to develop the capacity to manufacture drug products substances. We have agreements with third-party manufacturers to supply bulk drug substances for our product candidates and with third parties to formulate, package and distribute our product candidates. Our employees include professionals with expertise in pharmaceutical manufacturing development, quality assurance and third partythird-party supplier management who oversee work conducted by third-party companies. We believe that we have on hand or can easily obtain sufficient amounts of product candidates to complete our currently contemplated clinical trials. All of the drug substances used in our product candidates currently are manufactured by single suppliers. While we have not experienced any supply disruptions, the number of manufacturers of the drug substances is limited. In the event it is necessary or advisable to acquire supplies from alternative suppliers, assuming commercially reasonable terms could be reached, the challenge would be the efficient transfer of technology and know-how from current manufactures to the new supplier. Formulation and distribution of our finished
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product candidates also currently are conducted by single suppliers but we believe that alternative sources for these services are readily available on commercially reasonable terms, subject to the efficient transfer of technology and know-how from current suppliers to the new supplier.
All of the current agreements for the supply of bulk drug substances for our product candidates and for the formulation or distribution of our product candidates relate solely to the development (including preclinical and clinical) of our product candidates. Under these contracts, our product candidates are manufactured upon our order of a specific quantity. In the event that we obtain marketing approval for a product candidate, we will qualify secondary suppliers for all key manufacturing activities supporting the marketing application.
Marketing and Collaboration
We do not currently have any sales and marketing capability, other than to potentially market our biodefense vaccine products directly to government agencies. With respect to other commercialization efforts, we currently intend to seek distribution and other collaboration arrangements for the sales and marketing of any product candidate that is approved, while also evaluating the potential to commercialize on our own in orphan disease indications. From time to time, we have had and are having strategic discussions with potential collaboration partners for our biodefense vaccine product candidates, although no assurance can be given that we will be able to enter into one or more collaboration agreements for our product candidate on acceptable terms, if at all. We believe that both military and civilian health authorities of the U.S. and other countries will increase their stockpiling of therapeutics and vaccines to treat and prevent diseases and conditions that could ensue following a bioterrorism attack.
On December 20, 2012, we re-acquired the North American and European commercial rights to oral BDP through an amendment of our collaboration and supply agreement with Sigma-Tau Pharmaceuticals, Inc., which is now known as Leadiant Biosciences, Inc. (“Leadiant”). The amendment requires us to make certain approval and commercialization milestone payments to Leadiant which could reach up to $6 million. In addition, we have agreed to pay Leadiant: (a) a royalty amount equal to 3% of all net sales of oral BDP made directly by us, and any third-party partner and/or their respective affiliates in the U.S., Canada, Mexico and in each country in the European Territory for the later to occur of: (i) a period of ten years from the first commercial sale of oral BDP in each country, or (ii) the expiration of our patents and patent applications relating to oral BDP in such country (the “Payment Period”); and (b) 15% of all up-front payments, milestone payments and any other consideration (exclusive of equity payments) received by us and/or a potential partner from us and/or potential partner’s licensees, distributors and agents for oral BDP in each relevant country in the territory, which amount will be paid on a product-by-product and a country-by-country basis for the Payment Period.
On August 25, 2013, we entered into an agreement with SciClone, Pharmaceuticals, Inc. (“SciClone”), pursuant to which SciClone provided us with access to its oral mucositis clinical and regulatory data library in exchange for exclusive commercialization rights for SGX942 in the People’s Republic of China, including Hong Kong and Macau, subject to the negotiation of economic terms. SciClone’s data library was generated from two sequential Phase 2 clinical studies conducted in 2010 and 2012 evaluating SciClone’s compound, SCV-07, for the treatment of oral mucositis caused by chemoradiation therapy in head and neck cancer patients, before SciClone terminated its program. By analyzing data available from the placebo subjects in the SciClone trials, we acquired valuable insight into disease progression, along with quantitative understanding of its incidence and severity in the head and neck cancer patient population. This information assisted us with the design of the SGX942 Phase 2 clinical trial, in which positive preliminary results were announced in December 2015.
On September 9, 2016, we and SciClone entered into an exclusive license agreement, pursuant to which we granted rights to SciClone to develop, promote, market, distribute and sell SGX942 in the People’s Republic of China, including Hong Kong and Macau, as well as Taiwan, South Korea and Vietnam. Under the terms of the license agreement, SciClone will be responsible for all aspects of development, product registration and commercialization in the territory,territories, having access to data generated by us. In exchange for exclusive rights, SciClone will pay us royalties on net sales, and we will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights. We also entered into a common stock purchase agreement with SciClone pursuant to which we sold 352,94223,530 shares of our common stock to SciClone for approximately $8.50$127.50 per share, for an aggregate price of $3,000,000.
$3 million.
Competition
Our competitors are pharmaceutical and biotechnology companies, most of whom have considerably greater financial, technical, and marketing resources than we do. Universities and other research institutions, including the U.S. Army Medical Research Institute of Infectious Diseases, also compete in the development of treatment technologies, and we face competition from other companies to acquire rights to those technologies.
SGX301HyBryte™ Competition
There is currently no approved cure for CTCL and treatments are prescribed to manage symptoms. The FDA has approved several treatments for later stages (IIB-IV) of CTCL and/or in conditions that are unresponsive to prior treatment. Three are targeted therapies (Targretin®-caps, Ontak® and Adcetris®), two are histone deacetylases inhibitors (Zolina®and Istodax®) and the remaining two are topical therapies (Valchor® and Targretin®-gel). There are currently no FDA approved therapies for the treatment of front-line, early stage (I-IIA) CTCL; however certain topical chemotherapies and topical, radiation, photophotodynamic and other therapies which are approved for indications other than CTCL are prescribed off-label for the treatment of early stage CTCL. These include narrow-band ultraviolet B (NB-UVB) light therapy and psoralen combined
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with ultraviolet A (UVA)UVA light therapy (“PUVA”); however, PUVA treatments are usually limited to three times per week and 200 times in total due to the potentially carcinogenic side effect.effect, while NB UVB is known to be effective against patches but less so against plaque lesions, common in early stage CTCL. There are other drugs currently in development that may have the potential to be used in early stage (I-IIA) CTCL, – oneprimarily in phaseearly Phase 1 and 2 (vorinostat)clinical studies. Other treatments for later stage disease are not considered direct competitors.
SGX302 Competition
There is currently no approved cure for psoriasis and others in phase 1. Vorinostattreatments are prescribed to manage symptoms. The FDA has been approved by the FDA to treat CTCL patients who have conditions that are unresponsive to other therapies. It currently is being studied in a phase 2 trialseveral topical and systemic treatments for psoriasis. Systemic therapies dominate the treatment of all stagessevere and increasingly the more severe moderate patients, and include biologics aimed at reducing systemic inflammation. Skin directed therapy remains the primary treatment for mild-to-moderate disease. Current therapies for mild-to-moderate disease include psoralen activated by ultraviolet A (“PUVA”, a photodynamic therapy), emollients, topical steroids, vitamin D preparations including retinoids (e.g., Sorilux®, Dovonex®, Cacitrene®), coal tar, salicylic acid, calcineurin inhibitors (e.g., Prograf®, Elidel®, Zorac®, Tazorac®) and dithranols (e.g., Drithocreme®). Other phototherapy approaches include the use of CTCL.both broad-band and narrow-band ultraviolet B light. There are also a number of ongoing Phase 2 and 3 clinical trials in mild to moderate psoriasis.
Compared to PUVA, photoactivated hypericin uses non-carcinogenic and more penetrative visible light (unlike ultraviolet light used with PUVA) and a non-mutagenic compound hypericin (unlike psoralen used with PUVA), and is more highly targeted and more commensurate with long-term treatment. Compared to other skin-directed therapies, photoactivated hypericin has demonstrated a comparatively low local irritancy/adverse event rate with minimal long-term skin effects. Compared to systemic therapies, commonly used in more severe patients only, photoactivated hypericin does not cause immunosuppression.
SGX94/942942/945 Competition
Because SGX94 (dusquetide) uses a novel mechanism of action in combating bacterial infections, there are no direct competitors at this time. Bacterial infections are routinely treated with antibiotics and SGX94 treatment is anticipated to be utilized primarily where antibiotics are insufficient (e.g., due to antibiotic resistance) or contra-indicated (e.g., in situations where the development of antibiotic resistance is a significant concern). Many groups are working on the antibiotic resistance problem and research into the innate immune system is intensifying, making emerging competition likely (from companies such as Celtaxsys Inc., Innaxon Therapeutics and Innate Pharma SA).
There is currently one drug approved for the treatment of oral mucositis in hematological cancer (palifermin). There are currently no approved drugs for treatment of oral mucositis in cancers with solid tumors (e.g., head and neck cancer). There are several drugs in clinical development for oral mucositis – twothree in Phase 3 (an epidermal growth factor under development(brilacidin by Daewoong Pharmaceutical Co. Ltd. andInnovation Pharmaceuticals, Inc., a protease inhibitor under investigation at a Chinese hospital), five in Phase 2 (under developmentmucobuccal tablet by Cellceutix Corporation, Intrexon Corporation, Monopar Therapeutics LLC and GC4419 by Galera Therapeutics, Inc., Moberg Pharma, and Alder Biopharmaceuticals Inc.) and. There are various natural products in small and/or open label studies (including sage, turmeric, honey and olive oil). In addition, there are medical devices approved for the treatment of oral mucositis including MuGard®, GelClair®, Episil®, and Caphosol.Caphosol®. These devices attempt to create a protective barrier around the oral ulceration with no biologic activity in treating the underlying disease.
Oral BDP Competition
There is currently no approved cure for BD and treatments are a number of approvedprescribed to manage symptoms. Treatments may include both maintenance therapies and those specifically addressing mucocutaneous flares (e.g., mouth ulcers, genital ulcers and leg ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side effects that become more concerning with more chronic use. Other treatments for Crohn’s disease and additional compounds are in late-stage development.
Remicade (infliximab) and Humira (adalimumab) are currently approved forBD flares involve suppressing the treatment of pediatric Crohn’s disease; however, both carry significant Black Box warnings in their labeling for increasedimmune system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of seriousinfection, liver and kidney problems, low blood counts and high blood pressure. For skin and mucosal manifestations of BD, anti-inflammatory drugs are also used, including colchicine, azathioprine, anti-TNF, anti-interferon alpha, anti-IL-17 and anti-IL-23 medications. The only approved drug in BD is apremilast, which is used as a maintenance therapy to prevent formation of oral ulcers. Apremilast is associated with both high cost and side effects including diarrhea, nausea, upper respiratory tract infection and malignancy, and therefore are approved for treatmentheadache.
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ThermoVax® Competition
Multiple groups and companies are working to address the unmet need of vaccine thermostability using a variety of technologies. In addition, other organizations, such as the Bill and Melinda Gates Foundation and PATH, have programs designed to advance technologies to address this need.
Several stabilization technologies currently being developed involve mixing vaccine antigen +/- adjuvant with various proprietary excipients or co-factors that either serve to stabilize the vaccine or biological product in a liquid or dried (lyophilized) form. Examples of these approaches include the use of various plant-derived sugars and macromolecules being developed by companies such as Stabilitech Ltd.iosBio. Variation Biotechnologies, Inc. (“VBI”) is developing a lipid system (resembling liposomes) to stabilize viral antigens, including virus-like particles (VLPs)(“VLPs”), and for potential application to a conventional influenza vaccine among others.
Other approaches involve process variations to freeze-dry live virus vaccines. For example, PaxVax, Inc. is seeking to employ a spray drying technology in concert with enteric coating to achieve formulations for room temperature stability of live virus vaccines using adenovirus vectors. VBI is seeking to utilize their proprietary stabilization technology for a number of vaccines (as a co-development service, similar to the business model being developed by Stabilitech Ltd.), whereas PaxVax is applying the technology to their own proprietary vaccine development programs. Stabilitech uses combinations of excipients, which include glassifying sugars similar to the ThermoVax® technology, and variations in drying cycles during lyophilization, as does the ThermoVax® technology.
Additionally, companies like Pharmathene,Altimmune, Inc., and Panacea Biotec Ltd., and Compass Biotech Inc. are developing proprietary vaccines with the application of some form of stabilization technology.
Vaccines/BioDefensePublic Health Solutions Competition
We face competition in the area of biodefense product development from various public and private companies, universities and governmental agencies, such as the U.S. Army, some of whom may have their own proprietary technologies which may directly compete with our technologies.
The U.S. Army Medical Research Institute of Infectious Diseases, the DoD’s lead laboratory for medical research to counter biological threats is also developing a ricin vaccine candidate, RVEc™. RVEc™ has been shown to be fully protective in mice exposed to lethal doses of ricin toxin by the aerosol route. Further studies, in both rabbits and nonhuman primates, were conducted to evaluate RVEc™’s safety as well as its immunogenicity, with positive results observed.
In the area of radiation-protective antidotes such as OrbeShield®, various companies, such as Cleveland Biolabs, No further data has been released in recent years. A monoclonal antibody is also being developed by Mapp Biopharmaceutical Inc., Pluristem Therapeutics, Inc., Aeolus Pharmaceuticals, Inc. Boulder Biotechnology, Inc., RxBio, Inc., Avaxia Biologics, Inc., Exponential Biotherapies, Inc., Osiris Therapeutics, Inc., ImmuneRegen BioSciences, Inc., Neumedicines, Inc., Cellerant Therapeutics, Inc., Onconova Therapeutics, Inc., Araim Pharmaceuticals, Inc., EVA Pharmaceuticals, LLC, Terapio Corporation, Cangene Corporation, Humanetics Corporation and the University of Arkansas Medical Sciences Center are developing biopharmaceutical products that may directly compete with OrbeShield®, even though their approaches to such treatment are different.
RxBio, Avaxia Biologics and the University of Arkansas have programs specifically for GI ARS. RxBio’s Rx100 is a stem cell protectant designed as a single dose (oral ricin therapeutic, with administration 4 hours after exposure demonstrating efficacy while administration 12 hours after ricin exposure was not protective in animal models.
There are no approved vaccines to prevent infection and/or injection) which has shown promise in nonhuman primate studies. Avaxia is developing an orally delivered anti-TNF antibody as a treatment agent formitigate exposure to radiation following a nuclear accident, attackSudan ebolavirus or explosion. Pasireotide, a drugMarburg marburgvirus. There are other vaccine candidates in development, by Novartis for Cushing’s disease, is being developed atprimarily using viral-vectored vaccine platforms. These platforms may be contra-indicated in the University of Arkansas to protect the intestine by reducing pancreatic secretions that exacerbate intestinal inflammation.
immune-compromised, pregnant individuals or children. They may also have limited efficacy on repeat administration.
Patents and Other Proprietary Rights
Our goal is to obtain, maintain and enforce patent protection for our products, formulations, processes, methods and other proprietary technologies, preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the U.S. and in other countries. Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our product candidates, proprietary information and proprietary technology through a combination of contractual arrangements and patents, both in the U.S. and elsewhere in the world.
We also depend upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of our advisors, consultants and other contractors, none of which is patentable. To help protect our proprietary knowledge and experience that is not patentable, and for inventions for which patents may be difficult to enforce, we rely on trade secret protection and confidentiality agreements to protect our interests. To this end, we require all employees, consultants, advisors and other contractors to enter into confidentiality agreements, which prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business.
In 2014, we acquired a novel photodynamic therapyPDT that utilizes safe visible light for activation, which we refer to as SGX301.HyBryte™. The active ingredient in SGX301HyBryte™ is synthetic hypericin, a photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. As part of the acquisition, we acquired a license agreement relating to the use of photo-activated hypericin, composition of matter patent for SGX301HyBryte™ (U.S. patent 8,629,302) and additional issued and pending applications, both in the USU.S. and abroad. U.S. patent 8,629,302 is expected to expire in June 2032.September 2030. In August 2018, we were granted a U.S. patent (No. 10,053,513) titled “Systems and Methods for Producing Synthetic
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Hypericin.” This newly issued patent, expected to expire in 2036, broadens the production around synthetic hypericin. Our proprietary formulation of synthetic hypericin also has been granted a European patent for the treatment of psoriasis, EP 2571507, and complements the method of treatment claims covered by the previously issued USU.S. patent 6001882, Photoactivated hypericin and the use thereof.
Further, on January 7, 2020, we also were granted a U.S. patent (No. 10,526,268) titled “Systems and Methods for Producing Synthetic Hypericin”, which further expanded protection for the composition of purified synthetic hypericin. This patent is also expected to expire in 2036. Patent protection is also pursued worldwide with similar patents and expiry dates.
In addition to issued and pending patents, we also have “Orphan Drug” designations for SGX301HyBryte™ in the U.S. and the EU for CTCL, SGX203 in the U.S. for pediatric Crohn’s disease, and OrbeShield® in the U.S. for GI ARS, as well as for RiVax® in the U.S. and EU. Our Orphan Drug designations provide for seven years of post-approval marketing exclusivity in the U.S. and ten years exclusivity in Europe. We have pending patent applications for this indication that, if granted, may extend our anticipated marketing exclusivity beyond the U.S. seven year or E.U.EU ten year post-approval exclusivity provided by Orphan Drug legislation.
In 2013, we expanded our patent portfolio to include innate defense regulation through the acquisition of the novel drug technology, known as SGX94. By binding to the pivotal regulatory protein p62, also known as sequestosome-1, SGX94 regulates the innate immune system to reduce inflammation, eliminate infection and enhance healing. As part of the acquisition, we acquired all rights, including composition of matter patents for SGX94 as well as other analogs and crystal structures of SGX94 with its protein target p62, including U.S. patent 8,124,721 (expiring 2028), 9,416,157 (expiring 2028) and additional pending applications,8,791,061 (expiring 2029), both in the U.S. and abroad. SGX94 was developed pursuant to discoveries made by Professors B. Brett Finlay and Robert Hancock of University of British Columbia (“UBC”). U.S.We also have rights to the background technology patents (U.S. patent 8,124,721 is expected to expire in April 2028.numbers 7,507,787 [expiring 2024], 7,687,454 [expiring 2026] and 11,311,598 [expiring 2034]). The U.S. Patent Office has also granted the patent entitledpatents titled “Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis”.Mucositis.” The newly issued patents (U.S. patent claimsnumbers 9,850.279 and 10,253,068, both expiring in 2034) claim therapeutic use of dusquetide and related IDR analogs, and adds to composition of matter claims for dusquetide and related analogs that have been granted in the U.S. and worldwide.
We have issued U.S. patents 8,263,582 and 6,096,731 that cover the use of oral BDP for treating inflammatory disorders of the gastrointestinal tract and the prevention and treatment of GI GVHD, respectively. U.S. patent numbers 8,263,582 and 6,096,731 are expected to expire in March 2022 and June 2018, respectively. We also have European patent EP 1392321 claiming the use of topically active corticosteroids in orally administered dosage forms that act concurrently to treat inflammation in the upper and lower gastrointestinal tract, as well as European patent EP 2242477 claiming the use of orally ingested BDP for treatment of interstitial lung disease. European patents EP 1392321 and EP 2242477 are expected to expire in March 2022 and January 2029.
The subject of U.S. patent application number 12/633,631 filed December 8, 2009 and corresponding European patent application number 09836727.9 is the use of topically active BDP in radiation and chemotherapeutics injury. Additionally, we have numerous patent filings currently issued or pending in foreign jurisdictions covering this subject matter, including Australia, Canada, China, Hong Kong, Israel, India, Japan, South Korea and New Zealand.
ThermoVax®is the subject of U.S. patentpatents 8,444,991 (expiring February 2030) and 8,808,710 (expiring March 2028) both issued on May 21, 2013 titled “Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition” and licensed to us by VitriVax, Inc. ThermoVax® is also U.S. patent application number 13/474,66115/694.023 filed MaySeptember 17, 20122017 titled “Thermostable Vaccine Compositions and Methods of Preparing Same.”Same” and jointly invented by the UC and the Company. The patent application and the corresponding foreign filings for both patents are pending and licensed to us by the University of Colorado (“UC”)or granted and they address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation. The license agreement covers thermostable alum-adjuvanted vaccines for biodefense as well as other potential vaccine indications. U.S. patent 8,444,991 is expected to expire in December 2031.
RiVax®is the subject of three issued U.S. patent numbers 6,566,500, 6,960,652, and 7,829,668, all titled “Compositions and methods for modifying toxic effects of proteinaceous compounds.” This patent family includes composition of matter claims for the modified ricin toxin A chain which is the immunogen contained in RiVax®, and issued in 2003, 2005Ebola virus. An additional patent, covering vaccine combinations such as ricin toxin and 2010 respectively. The initial filing date of these patents is March 2000 and they are expected to expire in March 2020. The issued patents contain claims that describe alteration of sequences within the ricin A chain that affect vascular leak, one of the deadly toxicities caused by ricin toxin. Another U.S. patent number 7,175,848 titled “Ricin A chain mutants lacking enzymatic activity as vaccines to protect against aerosolized ricin,”anthrax, was filed in October2015 and granted on May 21, 2019 in the U.S. (No. 10,293,041, titled “Multivalent Stable Vaccine Composition and Methods of 2000Making Same”) and is expected to expire in October 2020.2035. A patent for unique, proprietary compositions and methods directed to combinations of glycoprotein antigens with nano-emulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization was filed in 2020, granted in 2022 and expiring in 2040 (No. 11,433,129 titled “Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines.”) Patent protection is also pursued worldwide with similar patents and expiry dates.
Additional vaccine thermostabilization patents specific for anti-viral vaccines, including filovirus and coronavirus have been filed but are not yet granted. If granted, expiry dates would range from 2040 to 2041. Patent protection is also pursued worldwide with similar patents and expiry dates.
SGX301HyBryte™ License Agreement
In September 2014, we acquired a worldwide exclusive license agreement with New York University and Yeda Research and Development Company Ltd. for the rights to a novel photodynamic therapyPDT that utilizes safe visible light for activation, which we refer to as SGX301.HyBryte™. To maintain this license, we are obligated to pay $25,000 in annual license fees. In addition, we will pay the licensors: (a) a royalty amount equal to 3% of all net sales of SGX301HyBryte™ made directly by us and/or any affiliates; (b) a royalty amount equal to 2.5% of all net sales of SGX301HyBryte™ made by our sublicensees, subject to stated maximums and (c) 20% of all payments, not based on net sales, received by us from our sublicensees. This license may be terminated by either party upon notice of a material breach by the other party that is not cured within the applicable cure period. The exclusive license includes rights to several issued U.S. patents, including U.S. patent numbers 6,867,235 and 7,122,518,
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among other domestic and foreign patent applications. U.S. Patent numbers 6,867,235 and 7,122,518 areexpired in January 2020 and is expected to expire in January 2020 and November 2023, respectively.
We acquired the license agreement for SGX301HyBryte™ and related intangible assets, including U.S. patent 8,629,302, properties and rights pursuant to an asset purchase agreement with Hy Biopharma Inc. (“Hy Biopharma”). As consideration for the assets acquired, we initially paid $275,000 in cash and issued 184,91212,328 shares of common stock with a market value of $3,750,000.$3,750,000, and in March 2020 we issued 130,413 shares of common stock at a value of $5,000,000 (based upon an effective per share price of $38.40) as a result of HyBryte™ demonstrating statistical significant treatment response in the Phase 3 clinical trial. Provided all futurethe final success-orientated milestones aremilestone is attained, we will be required to make paymentsa payment of up to $10.0$5 million, if and when achieved, payable in our common stock of the Company.
stock.
SGX94 License Agreements
On December 18, 2012, we announced the acquisition ofacquired a first in class drug technology, known as SGX94 (dusquetide), representing a novel approach to modulation of the innate immune system. SGX94 is an IDR that regulates the innate immune system to reduce inflammation, eliminate infection and enhance tissue healing by binding to the pivotal regulatory protein p62, also known as sequestosome-1. As part of the acquisition, we acquired all rights, including composition of matter patents, preclinical and Phase 1 clinical study datasets for SGX94. We also assumed a license agreement with UBC to advance the research and development of the SGX94 technology. The license agreement with UBC provides us with exclusive worldwide rights to manufacture, distribute, market sell and/or license or sublicense products derived or developed from this technology. Under the license agreement we are obligated to pay UBC (i) an annual license maintenance fee of CANCAD $1,000, and (ii) milestone payments which could reach up to CANCAD $1.2 million. This license agreement (a) will automatically terminate if we file, or become subject to an involuntary filing, for bankruptcy, and (b) may be terminated by UBC in the event of, among other things, our insolvency, dissolution, grant of a security interest in the technology licensed to us pursuant to the license agreement, or material breach of or failure to perform material obligations under the license agreement or other research agreements between us and UBC.
Oral BDP License Agreement
On November 24, 1998, the Company, known at the time as Enteron Pharmaceuticals, Inc. (“Enteron”) and George B. McDonald (“Dr. McDonald”) entered into an exclusive license agreement for the rights to intellectual property, including know-how, relating to oral BDP. The Company has an exclusive license to commercially exploit the covered products worldwide, subject to Dr. McDonald’s right to make and use the technology for research purposes and the U.S. Government’s right to use the technology for government purposes. Pursuant to the license agreement, as amended, the Company is required to (i) reimburse Dr. McDonald for certain out-of-pocket expenses incurred by Dr. McDonald in connection with the patent applications and issued patents, (ii) pay Dr. McDonald $300,000 upon approval by the FDA of the Company’s first NDA incorporating oral BDP; (iii) pay Dr. McDonald royalty payments equal to 3% of net sales of the covered products and (iv) pay Dr. McDonald $400,000 in cash upon an approval of oral BDP by the European Medicines Agency.
Additionally, in the event that the Company sublicenses its rights under the license agreement, the Company will be required to pay Dr. McDonald 10% of any sublicense fees and royalty payments paid by the sublicense to the Company.
The term of the license agreement expires upon the expiration of the licensed patent applications or patents. Dr. McDonald has the right to terminate the license agreement in its entirety or to terminate exclusivity under the agreement if the Company or its sublicense has not commercialized or are not actively attempting to commercialize a covered product.
Additionally, the agreement terminates: (i) automatically upon the Company becoming insolvent; (ii) upon 30 days’ notice, if the Company breaches any obligation under the agreement without curing such breach during the notice period; and (iii) upon 90 days’ notice by the Company. After any termination, the Company will have the right to sell its inventory for a period not to exceed three months following the date of termination, subject to the payment of the amounts owed under the agreement.
ThermoVax® License Agreement
On December 21, 2010, we executed a worldwide exclusive license agreement with the UC for ThermoVax®ThermoVax®, which is the subject of U.S. patent number 8,444,991 issued on May 21, 2013 titled “Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition.” This patent and its corresponding foreign filings are licensed to us by the UC and they address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation. U.S. Patent 8,444,991 is expected to expire in December 2031. The license agreement also covers thermostable vaccines for biodefense as well as other potential vaccine indications. In addition, we, in conjunction with UC, filed domestic and foreign patent applications claiming priority back to a provisional application filed on May 17, 2011 titled: “Thermostable Vaccine Compositions and Methods of Preparing Same.” To maintain thisIn April 2018, the UC delivered a notice of termination of our license we are obligatedagreement based upon our failure to pay minimum annual license feesachieve one of $15,000 until the development milestones: initiation of clinical trials, $20,000 following the initiation of a Phase 1 clinical trial of the heat stabilization technology by March 31, 2018. After negotiating with the UC, we and $50,000 following the UC agreed to extend the termination date to October 31, 2018 in order to allow us time to agree upon a potential agreement that would allow us to keep the rights to, and to continue to develop, the heat stabilization technology or a product candidate containing the heat stabilization technology in our field of use.
On October 31, 2018, in a series of related transactions, (a) we and the UC agreed to terminate the original license agreement, (b) the UC and VitriVax executed a worldwide exclusive license agreement for the heat stabilization technology for all fields of use, and (c) we and VitriVax executed a worldwide exclusive sublicense agreement, which was amended and restated in October 2020, for the heat stabilization technology for use in the fields of ricin and Ebola vaccines. We paid a $100,000 sublicense fee on the effective date of the sublicense agreement. Under the amended sublicense agreement to maintain the sublicense we are obliged to pay a minimum annual royalty of $20,000 until first commercial sale of a sublicensed product, incorporating ThermoVax®. Under the license agreementupon which point, we are obligatedwill be required to pay the UC (i)an earned royalty payments equal toof 2% of net sales subject to a minimum royalty of $50,000 each year. We are also required to pay royalties on any sub-sublicense income based on a declining percentage of all sub-sublicense income calculated within the contractual period until reaching a minimum of 15% after two years. In addition, we are required to pay VitriVax milestone fees of: (a) $25,000 upon initiation of a Phase 2 clinical trial of the covered products, (ii) 15%sublicensed product, (b) $100,000 upon initiation of all income from sublicensesa Phase 3 clinical trial of the sublicensed product, (c) $100,000 upon regulatory approval of a sublicensed product, and (iii) milestone payments which could reach up to $1.25 million.(d) $1 million upon achieving $10 million in aggregate net sales of a sublicensed product in the U.S. or equivalent. To date none of these milestones have been met.
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RiVax®License Agreement
In June 2003, we executed a worldwide exclusive option to license patent applications with UTSW for the nasal, pulmonary and oral uses of a non-toxic ricin vaccine. In June 2004, we entered into a license agreement with UTSW for the injectable rights to the ricin vaccine and, in October 2004, we negotiated the remaining oral rights to the ricin vaccine. To maintain this license, we are obligated to pay $50,000 in annual license fees. Through this license, we have rights to the issued patent number 7,175,848 titled “Ricin A chain mutants lacking enzymatic activity as vaccines to protect against aerosolized ricin.” This patent includes methods of use and composition claims for RiVax®.
CoVaccine HT™ License Agreement
In April 2020, we executed an agreement for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant, from BTG, a division of Boston Scientific Corporation (NYSE: BSX), for the fields of SARS-CoV-2, the cause of COVID-19 and pandemic flu. The agreement was executed with Protherics Medicines Development, one of the companies that make up the BTG specialty pharmaceuticals business, which owns the CoVaccine HT™ intellectual property.
Research and Development Expenditures
We spent approximately $5.5$3.3 million and $4.3$7.9 million in the years ended December 31, 20172023 and 2016,2022, respectively, on research and development. The amounts we spent on research and development per product during the years ended December 31, 2017,2023 and 20162022 are set forth in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Annual Report on Form 10-K.
Human Capital
Employees
We are committed to a work environment that is welcoming, inclusive and encouraging. To achieve our plans and goals, it is imperative that we attract and retain top talent. In order to do so, we aim to have a safe and encouraging workplace, with opportunities for our employees to grow and develop professionally, supported by strong compensation, benefits, and other incentives. In addition to competitive base salaries, we offer every full-time employee a cash target bonus, a comprehensive benefits package and equity compensation.
As of December 31, 2017,2023, we had 18employed a total of 15 persons, including 2 part-time employees and 13 full-time employees, 7five of whom are MDs/PhDs. In addition to our employees, we contract with third-parties for the conduct of certain clinical development, manufacturing, accounting and administrative activities. We anticipate increasing the number of our employees. We have no collective bargaining agreements with our employees, and none are represented by labor unions. We consider our relationships with our employees to be good.
Throughout the COVID 19 pandemic, many of our employees have worked remotely. In September 2021 our employees returned to the Company’s facilities in-person and have maintained a hybrid work schedule with both in-office and remote hours.
Available Investor Information
We file electronically with the Securities and Exchange Commission (“SEC”) our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) of 15(d) of the Securities Exchange Act of 1934, as amended.amended (the “Exchange Act”). We make available through our website, free of charge, copies of these reports as soon as reasonably practicable after we electronically file or furnish them to the SEC. Our website is located at http://www.soligenix.com. You can also request copies of such documents by contacting the company at (609) 538-8200 or sending an email to info@soligenix.com.
An investment in our securities involves a high degree of risk. You should carefully consider the following information about these risks, together with the other information about these risks contained in this Annual Report, as well as the other information contained in this Annual Report generally, before deciding to buy our securities. Any of the risks we describe below could adversely affect our business, financial condition, operating results or prospects. The market prices for our
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securities could decline if one or more of these risks and uncertainties develop into actual events and you could lose all or part of your investment. Additional risks and uncertainties that we do not yet know of, or that we currently think are immaterial, may also impair our business operations. You should also refer to the other information contained in this Annual Report, including our financial statements and the related notes.
Summary of Risk Factors
Our business is subject to a number of risks and uncertainties that you should understand before making an investment decision. These risks include, but are not limited to, the following:
Risks Related to our Business
| ● | We have had significant losses and anticipate future losses; if additional funding cannot be obtained, we may reduce or discontinue our product development and commercialization efforts or not be able to repay certain convertible notes. |
| ● | Our losses from operations, negative cash flows, and shareholders’ deficit as of December 31, 2023 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings. |
| ● | The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2023 contains an explanatory paragraph relating to our ability to continue as a going concern. |
| ● | If we are unable to develop our product candidates, our ability to generate revenues and viability as a company will be significantly impaired. |
| ● | We have no approved products on the market and therefore do not expect to generate any revenues from product sales in the foreseeable future, if at all. |
| ● | Our business is subject to extensive governmental regulation, which can be costly, time consuming and subjects us to unanticipated delays. |
| ● | There may be unforeseen challenges in developing our biodefense products. |
| ● | We are dependent on government funding, which is inherently uncertain, for the success of our public health business segment operations. |
| ● | The terms of our loan and security agreement with Pontifax Medison Finance require, and any future debt financing may require, us to meet certain operating covenants and place restrictions on our operating and financial flexibility. |
| ● | If the parties we depend on for supplying our drug substance raw materials and certain manufacturing-related services do not timely supply these products and services, it may delay or impair our ability to develop, manufacture and market our products. |
| ● | If we are not able to maintain or secure agreements with third parties for pre-clinical and clinical trials of our product candidates on acceptable terms, if these third parties do not perform their services as required, or if these third parties fail to timely transfer any regulatory information held by them to us, we may not be able to obtain regulatory approval for, or commercialize, our product candidates. |
| ● | The manufacturing of our products is a highly exacting process, and if we or one of our materials suppliers encounter problems manufacturing our products, our business could suffer. |
| ● | We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success. |
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| ● | Even if approved, our products will be subject to extensive post-approval regulation. |
| ● | Even if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market. |
| ● | We do not have extensive sales and marketing experience and our lack of experience may restrict our success in commercializing some of our product candidates. |
| ● | Our products, if approved, may not be commercially viable due to change in health care practice and third party reimbursement limitations. |
| ● | Our product candidates may cause serious adverse events or undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales. |
| ● | If we fail to obtain or maintain orphan drug exclusivity for our product candidates, our competitors may sell products to treat the same conditions and our revenue will be reduced. |
| ● | Federal and/or state health care reform initiatives could negatively affect our business. |
| ● | We may not be able to retain rights licensed to us by third parties to commercialize key products or to develop the third party relationships we need to develop, manufacture and market our products. |
| ● | We may suffer product and other liability claims; we maintain only limited product liability insurance, which may not be sufficient. |
| ● | We may use hazardous chemicals in our business. Potential claims relating to improper handling, storage or disposal of these chemicals could affect us and be time consuming and costly. |
| ● | We may not be able to compete with our larger and better-financed competitors in the biotechnology industry. |
| ● | Competition and technological change may make our product candidates and technologies less attractive or obsolete. |
| ● | Our business could be harmed if we fail to retain our current personnel or if they are unable to effectively run our business. |
| ● | Instability and volatility in the financial markets could have a negative impact on our business, financial condition, results of operations, and cash flows. |
| ● | Adverse developments affecting financial institutions such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity. |
| ● | We may not be able to utilize all of our net operating loss carryforwards. |
| ● | Global pathogens could have an impact on financial markets, materials sourcing, patients, governments and population (e.g. COVID-19). |
Risks Related to our Intellectual Property
| ● | We may be unable to commercialize our products if we are unable to protect our proprietary rights, and we may be liable for significant costs and damages if we face a claim of intellectual property infringement by a third party. |
| ● | We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming. |
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| ● | If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and defend against litigation. |
Risks Related to Technology and Intellectual Property
| ● | Our strategy includes an increasing dependence on technology in our operations. If any of our key technology fails, our business could be adversely affected. |
| ● | A cybersecurity incident could negatively impact our business and our relationships with our employees, service providers, patients, clinical study sites and government agencies. |
Risks Related to our Securities
| ● | The price of our common stock may be highly volatile. |
| ● | If we fail to meet Nasdaq’s listing requirements, we could be removed from The Nasdaq Capital Market, which would limit the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market and negatively impact our ability to raise capital. |
| ● | Shareholders may suffer substantial dilution related to issued stock warrants, options and convertible notes. |
| ● | Our shares of common stock are thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell shares to raise money or otherwise desire to liquidate their shares. |
| ● | Our common stock is deemed to be a “penny stock,” which may make it more difficult for investors to sell their shares due to suitability requirements. |
| ● | We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common stock. |
| ● | Upon our dissolution, our stockholders may not recoup all or any portion of their investment. |
| ● | The issuance of our common stock pursuant to the terms of the asset purchase agreement with Hy Biopharma may cause dilution and the issuance of such shares of common stock, or the perception that such issuances may occur, could cause the price of our common stock to fall. |
| ● | Repayment of certain convertible notes, if they are not otherwise converted, will require a significant amount of cash, and we may not have sufficient cash flow from our business to make payments on our indebtedness. |
| ● | The issuance of shares of common stock upon conversion of certain convertible notes could substantially dilute shareholders’ investments and could impede our ability to obtain additional financing. |
| ● | Our Board of Directors can, without stockholder approval, cause preferred stock to be issued on terms that adversely affect holders of our common stock. |
Risks Related to our Business
We have had significant losses and anticipate future losses; if additional funding cannot be obtained, we may reduce or discontinue our product development and commercialization efforts.
We have experienced significant losses since inception and, at December 31, 2017,2023, had an accumulated deficit of approximately $157$225.7 million. We expect to incur additional operating losses in the future and expect our cumulative losses to increase. As of December 31, 2017,2023, we had approximately $7.8$8.4 million in cash and cash equivalents available, and as of March 8, 2024 we had approximately $7.5 million in cash and cash equivalents available. BasedWithout additional funding,
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based on our projected budgetary needs and funding from existing contracts and grants over the next two years and sales to the purchasers under our existing equity line,year, we expect to be able to maintain the current level of our operations through at least March 31, 2019.
into the fourth quarter of 2024.
In September 2014, we entered into a contract with the National Institutes of Health (“NIH”)NIH for the development of RiVax® to protect against exposure to ricin toxin that would provide up to $24.7 million of funding in the aggregate over six years if options to extend the contract are exercised by the NIH. In September 2013, we entered into contracts with NIAID and BARDA for the development of OrbeShield® that would provide up to $32.7 million of funding in the aggregate if options to extend the contracts are exercised by BARDA and the NIH. We have received approximately $18 million in combined BARDA and NIH contract funding for the development of OrbeShield®. We have completed the contract with NIAID and the BARDA contract base period, with BARDA electing not to extend the contract. In addition, in 2017, we were awarded two separate grants from the NIH of approximately $1.5 million each to support our pivotal Phase 3 trials of SGX301HyBryte™ for the treatment of CTCL and SGX942 for the treatment of oral mucositis in head and neck cancer. In December 2020, we were awarded Direct to Phase II SBIR grant from NIAID of approximately $1.5 million to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 and EVD vaccine candidates in conjunction with the CoVaccine HT™ adjuvant. Our biodefense grants have an overhead component that allows us an agency-approved percentage over our incurred costs. We estimate that the overhead component associated with our existing contracts and grants will fund some fixed costs for direct employees working on these contracts and grants as well as other administrative costs. We haveAs of December 31, 2023, we had approximately $19.6 million$844,000 in awarded contract and grant funding assuming the NIAID options are exercised for the development of RiVax®. BARDA has elected not to fund the additional options remaining under the contract.
available.
Our product candidates are positioned for or are currently in clinical trials, and we have not yet generated any significant revenues from sales or licensing of these product candidates. From inception through December 31, 2017,2023, we have expended approximately $76.0$119 million developing our current product candidates for pre-clinical research and development and clinical trials, and wetrials. We currently expect to spend approximately $10.7$5.5 million overfor the 12 month period fromyear ending December 31, 20172024 in connection with the development of our therapeutic and vaccine products, licenses, employment agreements, and consulting agreements, of which approximately $5.2$0.3 million is expected to be reimbursed through our existing government contracts and grants.
We have no control over the resources and funding NIH, BARDA and NIAIDU.S. government agencies may devote to our programs, which may be subject to periodic renewal and which generally may be terminated by the government at any time for convenience. Any significant reductions in the funding of U.S. government agencies or in the funding areas targeted by our business could materially and adversely affect our biodefense program and our results of operations and financial condition. If we fail to satisfy our obligations under the government contracts, the applicable Federal Acquisition Regulations allow the government to terminate the agreement in whole or in part, and we may be required to perform corrective actions, including but not limited to delivering to the government any incomplete work. If NIH, BARDA or NIAIDU.S. government agencies do not exercise future funding options under the contracts or grants, terminate the funding or fail to perform their responsibilities under the agreements or grants, it could materially impact our biodefense program and our financial results.
Unless and until we are able to generate sales or licensing revenue from one of our product candidates, we will require additional funding to meet these commitments, sustain our research and development efforts, provide for future clinical trials, and continue our operations. There can be no assurance we can raise such funds. If additional funds are raised through the issuance of equity securities, stockholders may experience dilution of their ownership interests, and the newly issued securities may have rights superior to those of the common stock. If additional funds are raised by the issuance of debt, we may be subject to limitations on our operations. If we cannot raise such additional funds, we may have to delay or stop some or all of our drug development programs.
Our losses from operations, negative cash flows, and shareholders' deficit as of December 31, 2023 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings.
We have concluded that substantial doubt exists about our ability to continue as a going concern for the 12 months following the issuance of the financial statements included in this Annual Report on Form 10-K. As of December 31, 2023, we had cash and cash equivalents of approximately $8.4 million and current liabilities of approximately $6.2 million. As of the issuance date of these financial statements, we believe that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations as they come due into the fourth quarter of 2024. We do not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to support our operations for at least the 12 months following the issuance of the financial statements.
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations, securing additional proceeds from government contract and grant programs, and potentially amending the loan agreement with Pontifax Medison Finance to reduce the conversion price in
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order to allow for conversion of a portion of the debt which will reduce our liabilities; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that we will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about our ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce our ability to access capital, which could negatively affect our liquidity and ability to continue as a going concern. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.
The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2023 contains an explanatory paragraph relating to our ability to continue as a going concern.
The auditor’s opinion on our audited financial statements for the year ended December 31, 2023 includes an explanatory paragraph stating that we have incurred recurring losses from operations that raise substantial doubt about our ability to continue as a going concern. While we believe that we will be able to obtain the capital we need to continue our operations, there can be no assurances that we will be successful in these efforts or will be able to resolve our liquidity issues or eliminate our operating losses. If we are unable to obtain sufficient funding, we would need to significantly reduce our operating plans and curtail some or all of our development efforts. Accordingly, our business, prospects, financial condition, and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.
If we are unable to develop our product candidates, our ability to generate revenues and viability as a company will be significantly impaired.
In order to generate revenues and profits, our organization must, along with corporate partners and collaborators, positively research, develop and commercialize our technologies or product candidates. Our current product candidates are in various stages of early clinical and pre-clinical development and will require significant further funding, research, development, pre-clinical and/or clinical testing, regulatory approval and commercialization, and are subject to the risks of failure inherent in the development of products based on innovative or novel technologies. Specifically, each of the following is possible with respect to any of our product candidates:
| ● | we may not be able to maintain our current research and development schedules; |
| ● | we may be unable to secure procurement contracts on beneficial economic terms or at all from the U.S. government or others for our biodefense products; |
| ● | we may encounter problems in clinical trials; or |
| ● | the technology or product may be found to be ineffective or unsafe, or may fail to obtain marketing approval. |
If any of the risks set forth above occur, or if we are unable to obtain the necessary regulatory approvals as discussed below, we may be unable to develop our technologies and product candidates and our business will be seriously harmed. Furthermore, for reasons including those set forth below, we may be unable to commercialize or receive royalties from the sale of any other technology we develop, even if it is shown to be effective, if:
| ● | it is not economical or the market for the product does not develop or diminishes; |
| ● | we are not able to enter into arrangements or collaborations to manufacture and/or market the product; |
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| ● | the product is not eligible for third-party reimbursement from government or private insurers; |
| ● | others hold proprietary rights that preclude us from commercializing the product; |
| ● | we are not able to manufacture the product reliably; |
| ● | others have brought to market similar or superior products; or |
| ● | the product has undesirable or unintended side effects that prevent or limit its commercial use. |
We expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance.
We are a late-stage biopharmaceutical company. Our operations to date have been primarily limited to developing our technology and undertaking pre-clinical studies and clinical trials of our product candidates in our two active business segments, Specialized BioTherapeutics and Vaccines/BioDefense.Public Health Solutions. We have not yet obtained regulatory approvals for any of our product candidates. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had commercialized products. Our financial condition has varied significantly in the past and will continue to fluctuate from quarter-to-quarter or year-to-year due to a variety of factors, many of which are beyond our control. Factors relating to our business that may contribute to these fluctuations include other factors described elsewhere in this Annual Report and also include:
| ● | our ability to obtain additional funding to develop our product candidates; |
| ● | our ability to repay existing debt in accordance with its terms; |
| ● | delays in the commencement, enrollment and timing of clinical trials; |
| ● | the success of our product candidates through all phases of clinical development; |
| ● | any delays in regulatory review and approval of product candidates in clinical development; |
| ● | our ability to obtain and maintain regulatory approval for our product candidates in the |
| ● | potential side effects of our product candidates that could delay or prevent commercialization, limit the indications for any approved drug, require the establishment of risk evaluation and mitigation strategies, or cause an approved drug to be taken off the market; |
| ● | our dependence on third-party contract manufacturing organizations to supply or manufacture our products; |
| ● | our dependence on contract research organizations to conduct our clinical trials; |
| ● | our ability to establish or maintain collaborations, licensing or other arrangements; |
| ● | market acceptance of our product candidates; |
| ● | our ability to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure or through strategic collaborations; |
| ● | competition from existing products or new products that may emerge; |
| ● | the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for our products; |
| ● | our ability to discover and develop additional product candidates; |
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| ● | our ability and our licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights important to our business; |
| ● | our ability to attract and retain key personnel to manage our business effectively; |
| ● | our ability to build our finance infrastructure and improve our accounting systems and controls; |
| ● | potential product liability claims; |
| ● | potential liabilities associated with hazardous materials; and |
| ● | our ability to obtain and maintain adequate insurance policies. |
Accordingly, the results of any quarterly or annual periods should not be relied upon as indications of future operating performance.
We have no approved products on the market and therefore do not expect to generate any revenues from product sales in the foreseeable future, if at all.
To date, we have no approved product on the market and have not generated any significant product revenues. We have funded our operations primarily from sales of our securities and from government contracts and grants. We have not received, and do not expect to receive for at least the next several years, if at all, any revenues from the commercialization of our product candidates. To obtain revenues from sales of our product candidates, we must succeed, either alone or with third parties, in developing, obtaining regulatory approval for, manufacturing and marketing drugs with commercial potential or successfully obtain government procurement or stockpiling agreements. We may never succeed in these activities, and we may not generate sufficient revenues to continue our business operations or achieve profitability.
Our business is subject to extensive governmental regulation, which can be costly, time consuming and subjects us to unanticipated delays.
Our business is subject to very stringent federal, foreign, state and local government laws and regulations, including the Federal Food, Drug and Cosmetic Act, the Environmental Protection Act, the Occupational Safety and Health Act, and state and local counterparts to these acts. These laws and regulations may be amended, additional laws and regulations may be enacted, and the policies of the FDA and other regulatory agencies may change.
The regulatory process applicable to our products requires pre-clinical and clinical testing of any product to establish its safety and efficacy. This testing can take many years, is uncertain as to outcome, and requires the expenditure of substantial capital and other resources. We estimate that the clinical trials of our product candidates that we have planned will take at least several years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. Favorable results in early studies or trials, if any, may not be repeated in later studies or trials. Even if our clinical trials are initiated and completed as planned, we cannot be certain that the results will support our product candidate claims. Success in preclinical testing, Phase 1 and Phase 2 clinical trials does not ensure that later Phase 2 or Phase 3 clinical trials will be successful. In addition, we, the FDA or other regulatory authorities may suspend clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or the FDA or other regulatory authorities find deficiencies in our submissions or conduct of our trials.
We may not be able to obtain, or we may experience difficulties and delays in obtaining, necessary domestic and foreign governmental clearances and approvals to market a product.product (for example, the FDA may not recognize fast track designation upon an NDA submission, resulting in no priority review and subjecting us to longer potential review times than originally anticipated). Also, even if regulatory approval of a product is granted, that approval may entail limitations on the indicated uses for which the product may be marketed.
Following any regulatory approval, a marketed product and its manufacturer are subject to continual regulatory review. Later discovery of problems with a product or manufacturer may result in restrictions on such product or manufacturer. These restrictions may include product recalls and suspension or withdrawal of the marketing approval for the product. Furthermore, the advertising, promotion and export, among other things, of a product are subject to extensive regulation by
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governmental authorities in the U.S. and other countries. If we fail to comply with applicable regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and/or criminal prosecution.
There may be unforeseen challenges in developing our biodefense products.
For development of biodefense vaccines and therapeutics, the FDA has instituted policies that are expected to result in accelerated approval. This includes approval for commercial use using the results of animal efficacy trials, rather than efficacy trials in humans, referred to as the Animal Rule. However, we will still have to establish that the vaccines we are developing are safe in humans at doses that are correlated with the beneficial effect in animals. Such clinical trials will also have to be completed in distinct populations that are subject to the countermeasures; for instance, the very young and the very old, and in pregnant women, if the countermeasure is to be licensed for civilian use. Other agencies will have an influence over the risk benefit scenarios for deploying the countermeasures and in establishing the number of doses utilized in the Strategic National Stockpile. We may not be able to sufficiently demonstrate the animal correlation to the satisfaction of the FDA, as these correlates are difficult to establish and are often unclear. Invocation of the Animal Rule may raise issues of confidence in the model systems even if the models have been validated. For many of the biological threats, the animal models are not available and we may have to develop the animal models, a time-consuming research effort. There are few historical precedents, or recent precedents, for the development of new countermeasurecountermeasures for bioterrorism agents. Despite the Animal Rule, the FDA may require large clinical trials to establish safety and immunogenicity before licensure and it may require safety and immunogenicity trials in additional populations. Approval of biodefense products may be subject to post-marketing studies, and could be restricted in use in only certain populations. The government’s biodefense priorities can change, which could adversely affect the commercial opportunity for the products we are developing. Further, other countries have not, at this time, established criteria for review and approval of these types of products outside their normal review process, i.e., there is no Animal Rule equivalent, and consequently there can be no assurance that we will be able to make a submission for marketing approval in foreign countries based on such animal data.
Additionally, few facilities in the United StatesU.S. and internationally have the capability to test animals with ricin, or otherwise assist us in qualifying the requisite animal models. We have to compete with other biodefense companies for access to this limited pool of highly specialized resources. We therefore may not be able to secure contracts to conduct the testing in a predictable timeframe or at all.
We are dependent on government funding, which is inherently uncertain, for the success of our biodefense operations.
We are subject to risks specifically associated with operating in the biodefense industry, which is a new and unproven business area. We do not anticipate that a significant commercial market will develop for our biodefense products. Because we anticipate that the principal potential purchasers of these products, as well as potential sources of research and development funds, will be the U.S. government and governmental agencies, the success of our biodefense division will be dependent in large part upon government spending decisions. The funding of government programs is dependent on budgetary limitations, congressional appropriations and administrative allotment of funds, all of which are inherently uncertain and may be affected by changes in U.S. government policies resulting from various political and military developments. Our receipt of government funding is also dependent on our ability to adhere to the terms and provisions of the original grant and contract documents and other regulations. We can provide no assurance that we will receive or continue to receive funding for grants and contracts we have been awarded. The loss of government funds could have a material adverse effect on our ability to progress our biodefense business.
The terms of our loan and security agreement with Pontifax Medison Finance require, and any future debt financing may require, us to meet certain operating covenants and place restrictions on our operating and financial flexibility.
In December 2020, we entered into a loan and security agreement with Pontifax Medison Finance (the “Loan and Security Agreement”), that is secured by a lien covering substantially all of our assets, other than our intellectual property and licenses for intellectual property. The Loan and Security Agreement contains customary affirmative and negative covenants and events of default. Affirmative covenants include, among others, covenants requiring us to protect and maintain our intellectual property and comply with all applicable laws, deliver certain financial reports, and maintain insurance coverage. Negative covenants include, among others, covenants restricting us from transferring any material portion of our assets, incurring additional indebtedness, engaging in mergers or acquisitions, changing foreign subsidiary voting rights, repurchasing shares, paying dividends or making other distributions, making certain investments, and creating other liens
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on our assets, including our intellectual property, in each case subject to customary exceptions. If we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility. These restrictions may include, among other things, limitations on borrowing and specific restrictions on the use of our assets, as well as prohibitions on our ability to create liens, pay dividends, redeem capital stock or make investments. If we default under the terms of the Loan and Security Agreement or any future debt facility, the lender may accelerate all of our repayment obligations and take control of our pledged assets, potentially requiring us to renegotiate our agreement on terms less favorable to us or to immediately cease operations. Further, if we are liquidated, the lender’s right to repayment would be senior to the rights of the holders of our common stock. The lender could declare a default upon the occurrence of any event that it interprets as a material adverse effect as defined under the Loan and Security Agreement or based upon our insolvency. Any declaration by the lender of an event of default could significantly harm our business and prospects and could cause the price of our common stock to decline.
If the parties we depend on for supplying our drug substance raw materials and certain manufacturing-related services do not timely supply these products and services, it may delay or impair our ability to develop, manufacture and market our products. We do not have or anticipate having internal manufacturing capabilities.
We rely on suppliers for our drug substance raw materials and third parties for certain manufacturing-related services to produce material that meets appropriate content, quality and stability standards, which material will be used in clinical trials of our products and, after approval, for commercial distribution. To succeed, clinical trials require adequate supplies of drug substance and drug product, which may be difficult or uneconomical to procure or manufacture. We and our suppliers and vendors may not be able to (i) produce our drug substance or drug product to appropriate standards for use in clinical studies, (ii) perform under any definitive manufacturing, supply or service agreements with us or (iii) remain in business for a sufficient time to be able to develop, produce, secure regulatory approval of and market our product candidates. If we do not maintain important manufacturing and service relationships, we may fail to find a replacement supplier or required vendor or develop our own manufacturing capabilities which could delay or impair our ability to obtain regulatory approval for our products and substantially increase our costs or deplete profit margins, if any. If we do find replacement manufacturers and vendors, we may not be able to enter into agreements with them on terms and conditions favorable to us and, there could be a substantial delay before a new facility could be qualified and registered with the FDA and foreign regulatory authorities.
We rely on third parties for pre-clinical and clinical trials of our product candidates and, in some cases, to maintain regulatory files for our product candidates. If we are not able to maintain or secure agreements with such third parties on acceptable terms, if these third parties do not perform their services as required, or if these third parties fail to timely transfer any regulatory information held by them to us, we may not be able to obtain regulatory approval for, or commercialize, our product candidates.
We rely on academic institutions, hospitals, clinics and other third-party collaborators for preclinical and clinical trials of our product candidates. Although we monitor, support, and/or oversee our pre-clinical and clinical trials, because we do not conduct these trials ourselves, we have less control over the timing and cost of these studies and the ability to recruit trial subjects than if we conducted these trials wholly by ourselves. If we are unable to maintain or enter into agreements with these third parties on acceptable terms, or if any such engagement is terminated, we may be unable to enroll patients on a timely basis or otherwise conduct our trials in the manner we anticipate. In addition, there is no guarantee that these third parties will devote adequate time and resources to our studies or perform as required by a contract or in accordance with regulatory requirements, including maintenance of clinical trial information regarding our product candidates. If these third parties fail to meet expected deadlines, fail to timely transfer to us any regulatory information, fail to adhere to protocols or fail to act in accordance with regulatory requirements or our agreements with them, or if they otherwise perform in a substandard manner or in a way that compromises the quality or accuracy of their activities or the data they obtain, then preclinical and/or clinical trials of our product candidates may be extended, delayed or terminated, or our data may be rejected by the FDA or regulatory agencies.
The manufacturing of our products is a highly exacting process, and if we or one of our materials suppliers encounter problems manufacturing our products, our business could suffer.
The FDA and foreign regulators require manufacturers to register manufacturing facilities. The FDA and foreign regulators also inspect these facilities to confirm compliance with current Good Manufacturing Practice (“cGMP”) or similar requirements that the FDA or foreign regulators establish. We, or our materials suppliers, may face manufacturing or quality control problems causing product production and shipment delays or a situation where we or the supplier may not be able
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to maintain compliance with the FDA’s cGMP requirements, or those of foreign regulators, necessary to continue manufacturing our drug substance. Any failure to comply with cGMP requirements or other FDA or foreign regulatory requirements could adversely affect our clinical research activities and our ability to market and develop our products.
We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
Because we have limited financial and human resources, we are currently focusing on the regulatory approval of certain product candidates. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on existing and future product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic alliance, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate in an area in which it would have been more advantageous to enter into a partnering arrangement.
Even if approved, our products will be subject to extensive post-approval regulation.
Once a product is approved, numerous post-approval requirements apply. Among other things, the holder of an approved New Drug Application (“NDA”)NDA is subject to periodic and other FDA monitoring and reporting obligations, including obligations to monitor and report adverse events and instances of the failure of a product to meet the specifications in the NDA. Application holders must submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling, or manufacturing process. Application holders must also submit advertising and other promotional material to the FDA and report on ongoing clinical trials.
Depending on the circumstances, failure to meet these post-approval requirements can result in criminal prosecution, fines, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, or refusal to allow us to enter into supply contracts, including government contracts. In addition, even if we comply with FDA and other requirements, new information regarding the safety or effectiveness of a product could lead the FDA to modify or withdraw product approval.
Even if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market.
Even if the FDA approves one or more of our product candidates, physicians and patients may not accept it or use it. Even if physicians and patients would like to use our products, our products may not gain market acceptance among healthcare payors such as managed care formularies, insurance companies or government programs such as Medicare or Medicaid. Acceptance and use of our products will depend upon a number of factors including: perceptions by members of the health care community, including physicians, about the safety and effectiveness of our drug or device product; cost-effectiveness of our product relative to competing products; availability of reimbursement for our product from government or other healthcare payers; and effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.
The degree of market acceptance of any product that we develop will depend on a number of factors, including:
| ● | cost-effectiveness; |
| ● | the safety and effectiveness of our products, including any significant potential side effects, as compared to alternative products or treatment methods; |
| ● | the timing of market entry as compared to competitive products; |
| ● | the rate of adoption of our products by doctors and nurses; |
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| ● | product labeling or product insert required by the FDA for each of our products; |
| ● | reimbursement policies of government and third-party payors; |
| ● | effectiveness of our sales, marketing and distribution capabilities and the effectiveness of such capabilities of our collaborative partners, if any; and |
| ● | unfavorable publicity concerning our products or any similar products. |
Our product candidates, if successfully developed, will compete with a number of products manufactured and marketed by major pharmaceutical companies, biotechnology companies and manufacturers of generic drugs. Our products may also compete with new products currently under development by others. Physicians, patients, third-party payors and the medical community may not accept and utilize any of our product candidates. If our products do not achieve market acceptance, we will not be able to generate significant revenues or become profitable.
Because we expect sales of our current product candidates, if approved, to generate substantially all of our product revenues for the foreseeable future, the failure of these products to find market acceptance would harm our business and could require us to seek additional financing.
We do not have extensive sales and marketing experience and our lack of experience may restrict our success in commercializing some of our product candidates.
We do not have extensive experience in marketing or selling pharmaceutical products whether in the U.S. or internationally. To obtain the expertise necessary to successfully market and sell any of our products, the development of our own commercial infrastructure and/or collaborative commercial arrangements and partnerships will be required. Our ability to make that investment and also execute our current operating plan is dependent on numerous factors, including, the performance of third party collaborators with whom we may contract.
Our products, if approved, may not be commercially viable due to change in health care practice and third party reimbursement limitations.
Recent initiativesInitiatives to reduce the federal deficit and to change health care delivery are increasing cost-containment efforts. We anticipate that Congress, state legislatures and the private sector will continue to review and assess alternative benefits, controls on health care spending through limitations on the growth of private health insurance premiums and Medicare and Medicaid spending, price controls on pharmaceuticals, and other fundamental changes to the health care delivery system. Any changes of this type could negatively impact the commercial viability of our products, if approved. Our ability to successfully commercialize our product candidates, if they are approved, will depend in part on the extent to which appropriate reimbursement codes and authorized cost reimbursement levels of these products and related treatment are obtained from governmental authorities, private health insurers and other organizations, such as health maintenance organizations. In the absence of national Medicare coverage determination, local contractors that administer the Medicare program may make their own coverage decisions. Any of our product candidates, if approved and when commercially available, may not be included within the then current Medicare coverage determination or the coverage determination of state Medicaid programs, private insurance companies or other health care providers. In addition, third-party payers are increasingly challenging the necessity and prices charged for medical products, treatments and services.
Our product candidates may cause serious adverse events or undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
Serious adverse events or undesirable side effects from any of our product candidates could arise either during clinical development or, if approved, after the approved product has been marketed. The results of future clinical trials may show that our product candidates cause serious adverse events or undesirable side effects, which could interrupt, delay or halt clinical trials, resulting in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities.
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If any of our product candidates cause serious adverse events or undesirable side effects:
| ● | regulatory authorities may impose a clinical hold which could result in substantial delays and adversely impact our ability to continue development of the product; |
| ● | regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies; |
| ● | we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product; |
| ● | we may be required to implement a risk minimization action plan, which could result in substantial cost increases and have a negative impact on our ability to commercialize the product; |
| ● | we may be required to limit the patients who can receive the product; |
| ● | we may be subject to limitations on how we promote the product; |
| ● | sales of the product may decrease significantly; |
| ● | regulatory authorities may require us to take our approved product off the market; |
| ● | we may be subject to litigation or product liability claims; and |
| ● | our reputation may suffer. |
Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from the sale of our products.
If we fail to obtain or maintain orphan drug exclusivity for our product candidates, our competitors may sell products to treat the same conditions and our revenue will be reduced.
Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 in the United States,U.S., or a patient population greater than 200,000 in the United StatesU.S. where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States.U.S. In the European Union,EU, the European Medicines Agency’s Committee for Orphan Medicinal Products grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention, or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the European Union.EU. Additionally, designation is granted for products intended for the diagnosis, prevention, or treatment of a life-threatening, seriously debilitating or serious and chronic condition when, without incentives, it is unlikely that sales of the drug in the European UnionEU would be sufficient to justify the necessary investment in developing the drug or biological product or where there is no satisfactory method of diagnosis, prevention, or treatment, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.
In the United States,U.S., orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. In addition, if a product receives the first FDA approval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity. In the European Union,EU, orphan drug designation entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity following drug or biological product approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.
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Even though we have orphan drug designation for SGX301HyBryte™ in the United StatesU.S. and Europe, and SGX203, RiVax®and OrbeShield®in the United States,U.S., we may not be the first to obtain marketing approval for any particular orphan indication due to the uncertainties associated with developing drugs or biologic products. Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties can be approved for the same condition. Absent patent or other intellectual property protection, even after an orphan drug is approved, the FDA or European Medicines Agency may subsequently approve the same drug with the same active moiety for the same condition if the FDA or European Medicines Agency concludes that the later drug is safer, more effective, or makes a major contribution to patient care.
Federal and/or state health care reform initiatives could negatively affect our business.
The availability of reimbursement by governmental and other third-party payers affects the market for any pharmaceutical product. These third-party payers continually attempt to contain or reduce the costs of healthcare. There have been a number of legislative and regulatory proposals to change the healthcare system and further proposals are likely. Medicare’s policies may decrease the market for our products. Significant uncertainty exists with respect to the reimbursement status of newly approved healthcare products.
In addition, third-partyThird-party payers are increasingly challenging the price and cost-effectiveness of medical products and services. Once approved, we might not be able to sell our products profitably or recoup the value of our investment in product development if reimbursement is unavailable or limited in scope, particularly for product candidates addressing small patient populations. On July 15, 2008, the Medicare Improvements for Patients and Providers Act of 2008 became law with a number of Medicare and Medicaid reforms to establish a bundled Medicare payment rate that includes services and drug/labs that were separately billed at that time. Bundling initiatives that have been implemented in other healthcare settings have occasionally resulted in lower utilization of services that had not previously been a part of the bundled payment.
In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. We expect that there will continue to be a number of U.S. federal and state proposals to implement governmental pricing controls. While we cannot predict whether such legislative or regulatory proposals will be adopted, the adoption of such proposals could have a material adverse effect on our business, financial condition and profitability.
We may not be able to retain rights licensed to us by third parties to commercialize key products or to develop the third party relationships we need to develop, manufacture and market our products.
We currently rely on license agreements from New York University, Yeda Research and Development Company Ltd., the University of Texas Southwestern Medical Center, the University of British Columbia, Harvard University, the University of Colorado, and George B. McDonald, MD as well as sublicense agreement from VitriVax for the rights to commercialize key product candidates. We may not be able to retain the rights granted under these agreements or negotiate additional agreements on reasonable terms, if at all. Our existing license agreements impose, and we expect that future license agreements will impose, various diligence, milestone payment, royalty, and other obligations on us. If we fail to comply with our obligations under these agreements, or we are subject to a bankruptcy, we may be required to make certain payments to the licensor, we may lose the exclusivity of our license, or the licensor may have the right to terminate the license, in which event we would not be able to develop or market products covered by the license.
Additionally, the milestone and other payments associated with these licenses will make it less profitable for us to develop our drug candidates. See “Business -– Patents and Other Proprietary Rights” for a description of our license agreements.
Licensing of intellectual property is of critical importance to our business and involves complex legal, business, and scientific issues. Disputes may arise regarding intellectual property subject to a licensing agreement, including but not limited to:
| ● | the scope of rights granted under the license agreement and other interpretation-related issues; |
| ● | the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
| ● | the sublicensing of patent and other rights; |
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| ● | our diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
| ● | the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our collaborators; and |
| ● | the priority of invention of patented technology. |
If disputes over intellectual property and other rights that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.
Additionally, the research resulting in certain of our licensed patent rights and technology was funded by the U.S. government. As a result, the government may have certain rights, or march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the government to use the invention for non-commercial purposes. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations or to give preference to U.S. industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States.U.S. Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations and prospects.
Furthermore, we currently have very limited product development capabilities and no manufacturing, marketing or sales capabilities. For us to research, develop and test our product candidates, we need to contract or partner with outside researchers, in most cases with or through those parties that did the original research and from whom we have licensed the technologies. If products are successfully developed and approved for commercialization, then we will need to enter into additional collaboration and other agreements with third parties to manufacture and market our products. We may not be able to induce the third parties to enter into these agreements, and, even if we are able to do so, the terms of these agreements may not be favorable to us. Our inability to enter into these agreements could delay or preclude the development, manufacture and/or marketing of some of our product candidates or could significantly increase the costs of doing so. In the future, we may grant to our development partners rights to license and commercialize pharmaceutical and related products developed under the agreements with them, and these rights may limit our flexibility in considering alternatives for the commercialization of these products. Furthermore, third-party manufacturers or suppliers may not be able to meet our needs with respect to timing, quantity and quality for the products.
Additionally, if we do not enter into relationships with additional third parties for the marketing of our products, if and when they are approved and ready for commercialization, we would have to build our own sales force or enter into commercialization agreements with other companies. Development of an effective sales force in any part of the world would require significant financial resources, time and expertise. We may not be able to obtain the financing necessary to establish a sales force in a timely or cost effective manner, if at all, and any sales force we are able to establish may not be capable of generating demand for our product candidates, if they are approved.
We may suffer product and other liability claims; we maintain only limited product liability insurance, which may not be sufficient.
The clinical testing, manufacture and sale of our products involves an inherent risk that human subjects in clinical testing or consumers of our products may suffer serious bodily injury or death due to side effects, allergic reactions or other unintended negative reactions to our products. As a result, product and other liability claims may be brought against us. We currently have clinical trial and product liability insurance with aggregate limits of liability of $10 million, which may not be sufficient to cover our potential liabilities. Because liability insurance is expensive and difficult to obtain, we may not be able to maintain existing insurance or obtain additional liability insurance on acceptable terms or with adequate coverage against potential liabilities. Furthermore, if any claims are brought against us, even if we are fully covered by insurance, we may suffer harm such as adverse publicity.
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We may use hazardous chemicals in our business. Potential claims relating to improper handling, storage or disposal of these chemicals could affect us and be time consuming and costly.
Our research and development processes and/or those of our third party contractors involve the controlled use of hazardous materials and chemicals. These hazardous chemicals are reagents and solvents typically found in a chemistry laboratory. Our operations also may produce hazardous waste products. Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal of hazardous materials. While we attempt to comply with all environmental laws and regulations, including those relating to the outsourcing of the disposal of all hazardous chemicals and waste products, we cannot eliminate the risk of contamination from or discharge of hazardous materials and any resultant injury. In the event of such an accident, we could be held liable for any resulting damages and any liability could materially adversely affect our business, financial condition and results of operations.
Compliance with environmental laws and regulations may be expensive. Current or future environmental regulations may impair our research, development or production efforts. We might have to pay civil damages in the event of an improper or unauthorized release of, or exposure of individuals to, hazardous materials. We are not insured against these environmental risks.
We may agree to indemnify our collaborators in some circumstances against damages and other liabilities arising out of development activities or products produced in connection with these collaborations.
In addition, the federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous or radioactive materials and waste products may require us to incur substantial compliance costs that could materially adversely affect our business, financial condition and results of operations.
We may not be able to compete with our larger and better financed competitors in the biotechnology industry.
The biotechnology industry is intensely competitive, subject to rapid change and sensitive to new product introductions or enhancements. Most of our existing competitors have greater financial resources, larger technical staffs, and larger research budgets than we have, as well as greater experience in developing products and conducting clinical trials. Our competition is particularly intense in the gastroenterology and transplant areas and is also intense in the therapeutic area of inflammatory bowel diseases. We face intense competition in the biodefense area from various public and private companies and universities as well as governmental agencies, such as the U.S. Army, which may have their own proprietary technologies that may directly compete with our technologies. In addition, there may be other companies that are currently developing competitive technologies and products or that may in the future develop technologies and products that are comparable or superior to our technologies and products. We may not be able to compete with our existing and future competitors, which could lead to the failure of our business.
Additionally, if a competitor receives FDA approval before we do for a drug that is similar to one of our product candidates, FDA approval for our product candidate may be precluded or delayed due to periods of non-patent exclusivity and/or the listing with the FDA by the competitor of patents covering its newly-approved drug product. Periods of non-patent exclusivity for new versions of existing drugs such as our current product candidates can extend up to three and one-half years. See “Business -– The Drug Approval Process.”
These competitive factors could require us to conduct substantial new research and development activities to establish new product targets, which would be costly and time consuming. These activities would adversely affect our ability to commercialize products and achieve revenue and profits.
Competition and technological change may make our product candidates and technologies less attractive or obsolete.
We compete with established pharmaceutical and biotechnology companies that are pursuing other forms of treatment for the same indications we are pursuing and that have greater financial and other resources. Other companies may succeed in developing products earlier than us, obtaining FDA approval for products more rapidly, or developing products that are more effective than our product candidates. Research and development by others may render our technology or product candidates obsolete or noncompetitive, or result in treatments or cures superior to any therapy we develop. We face competition from companies that internally develop competing technology or acquire competing technology from universities and other research institutions. As these companies develop their technologies, they may develop competitive positions that may prevent, make futile, or limit our product commercialization efforts, which would result in a decrease in the revenue we would be able to derive from the sale of any products.
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There can be no assurance that any of our product candidates will be accepted by the marketplace as readily as these or other competing treatments. Furthermore, if our competitors’ products are approved before ours, it could be more difficult for us to obtain approval from the FDA. Even if our products are successfully developed and approved for use by all governing regulatory bodies, there can be no assurance that physicians and patients will accept our product(s) as a treatment of choice.
Furthermore, the pharmaceutical research industry is diverse, complex, and rapidly changing. By its nature, the business risks associated therewith are numerous and significant. The effects of competition, intellectual property disputes, market acceptance, and FDA regulations preclude us from forecasting revenues or income with certainty or even confidence.
Our business could be harmed if we fail to retain our current personnel or if they are unable to effectively run our business.
We currently have 15 employees and we depend upon these employees, in particular Dr. Christopher Schaber, our President and Chief Executive Officer, to manage the day-to-day activities of our business. Because we have such limited personnel, the loss of any of them or our inability to attract and retain other qualified employees in a timely manner would likely have a negative impact on our operations. We may be unable to effectively manage and operate our business, and our business may suffer, if we lose the services of our employees.
Instability and volatility in the financial markets could have a negative impact on our business, financial condition, results of operations, and cash flows.
During recent years, there has been substantial volatility in financial markets due at least in part to the uncertainty with regard to the global economic environment. In addition, there has been substantial uncertainty in the capital markets and access to additional financing is uncertain. Moreover, customer spending habits may be adversely affected by current and future economic conditions. These conditions could have an adverse effect on our industry and business, including our financial condition, results of operations, and cash flows.
To the extent that we do not generate sufficient cash from operations, we may need to issue stock or incur indebtedness to finance our plans for growth. Recent turmoil in the credit markets and the potential impact on the liquidity of major financial institutions may have an adverse effect on our ability to fund our business strategy through borrowings, under either existing or newly created instruments in the public or private markets on terms we believe to be reasonable, if at all.
Adverse developments affecting financial institutions such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity.
Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, or concerns or rumors about any events of these kinds, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (the “FDIC”) as receiver. Despite subsequent actions taken by the U.S. Department of the Treasury, the U.S. Federal Reserve and the FDIC to ensure that all depositors of SVB had access to all of their cash deposits following the closure of SVB, uncertainty and liquidity concerns in the broader financial services industry remain.
We maintain cash balances at a third-party financial institution in excess of the FDIC insurance limit. Our access to our cash and cash equivalents in amounts adequate to finance our operations could be significantly impaired to the extent the financial institution with which we maintain cash balances faces liquidity constraints or failures. Any material decline in our ability to access our cash and cash equivalents could adversely impact our ability to meet our operating expenses, result in breaches of our contractual obligations or result in significant disruptions to our business, any of which could have material adverse impacts on our operations and liquidity. There is no guarantee that the U.S. Department of Treasury, the U.S. Federal Reserve and the FDIC will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions in a timely fashion or at all.
We may not be able to utilize all of our net operating loss carryforwards.
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused net operating loss (“NOL”) carryforwards to other New Jersey-based corporate taxpayers. In accordance with this program, during the year ended December 31, 2017, we We
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sold 2022, 2021 and 2020 New Jersey NOL carryforwards, resulting in the recognition of $416,810$1,767,803 and $1,154,935 of income tax benefit.benefit, net of transaction costs during the years ended December 31, 2023 and 2022, respectively. We have not yet sold our 2023 New Jersey NOL carryforwards but may do so in the future. If there is an unfavorable change in the State of New Jersey’s Technology Business Tax Certificate Program (whether as a result of a change in law, policy or otherwise) that terminates the program or eliminates or reduces our ability to use or sell our NOL carryforwards or if we are unable to find a suitable buyer to utilize our New Jersey NOL carryforwards to the extent the NOLs expire before we are able to utilize them against our taxable income, our cash taxes may increase which may have an adverse effect on our financial condition.
Global pathogens that could have an impact on financial markets, materials sourcing, patients, governments and population (e.g. COVID-19).
Global pathogens (e.g., SARS-CoV-2, the pathogen responsible for COVID-19) could cause an impact on financial markets and therefore repercussions to our operating business, including but not limited to, the sourcing of materials for our product candidates, manufacture of supplies for our preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for our trials due to such things as quarantines, our conduct of patient monitoring and clinical trial data retrieval at investigational study sites.
The impacts of outbreaks are highly uncertain and cannot be predicted, and we cannot provide any assurance that any outbreak will not have a material adverse impact on our operations or future results or filings with regulatory health authorities. The extent of the impact to us, if any, will depend on future developments, including actions taken to contain the pathogen.
Risks Related to our Intellectual Property
We may be unable to commercialize our products if we are unable to protect our proprietary rights, and we may be liable for significant costs and damages if we face a claim of intellectual property infringement by a third party.
Our near and long termlong-term prospects depend in part on our ability to obtain and maintain patents, protect trade secrets and operate without infringing upon the proprietary rights of others. In the absence of patent and trade secret protection, competitors may adversely affect our business by independently developing and marketing substantially equivalent or superior products and technology, possibly at lower prices. We could also incur substantial costs in litigation and suffer diversion of attention of technical and management personnel if we are required to defend ourselves in intellectual property infringement suits brought by third parties, with or without merit, or if we are required to initiate litigation against others to protect or assert our intellectual property rights. Moreover, any such litigation may not be resolved in our favor.
Although we and our licensors have filed various patent applications covering the uses of our product candidates, patents may not be issued from the patent applications already filed or from applications that we might file in the future. Moreover, the patent position of companies in the pharmaceutical industry generally involves complex legal and factual questions, and recently has been the subject of much litigation. Any patents we own or license, now or in the future, may be challenged, invalidated or circumvented. To date, no consistent policy has been developed in the U.S. Patent and Trademark Office (the “PTO”) regarding the breadth of claims allowed in biotechnology patents.
In addition, because patent applications in the U.S. are maintained in secrecy until patent applications publish or patents issue, and because publication of discoveries in the scientific or patent literature often lags behind actual discoveries, we cannot be certain that we and our licensors are the first creators of inventions covered by any licensed patent applications or patents or that we or they are the first to file. The PTO may commence interference proceedings involving patents or patent applications, in which the question of first inventorship is contested. Accordingly, the patents owned or licensed to us may not be valid or may not afford us protection against competitors with similar technology, and the patent applications licensed to us may not result in the issuance of patents.
It is also possible that our owned and licensed technologies may infringe on patents or other rights owned by others, and licenses to which may not be available to us. We may be unable to obtain a license under such patent on terms favorable to us, if at all. We may have to alter our products or processes, pay licensing fees or cease activities altogether because of patent rights of third parties.
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In addition to the products for which we have patents or have filed patent applications, we rely upon unpatented proprietary technology and may not be able to meaningfully protect our rights with regard to that unpatented proprietary technology. Furthermore, to the extent that consultants, key employees or other third parties apply technological information developed by them or by others to any of our proposed projects, disputes may arise as to the proprietary rights to this information, which may not be resolved in our favor.
We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming.
The pharmaceutical industry has been characterized by extensive litigation regarding patents and other intellectual property rights, and companies have employed intellectual property litigation to gain a competitive advantage. We may become subject to infringement claims or litigation arising out of patents and pending applications of our competitors, or additional interference proceedings declared by the PTO to determine the priority of inventions. The defense and prosecution of intellectual property suits, PTO proceedings, and related legal and administrative proceedings are costly and time-consuming to pursue, and their outcome is uncertain. Litigation may be necessary to enforce our issued patents, to protect our trade secrets and know-how, or to determine the enforceability, scope, and validity of the proprietary rights of others. An adverse determination in litigation or interference proceedings to which we may become a party could subject us to significant liabilities, require us to obtain licenses from third parties, or restrict or prevent us from selling our products in certain markets. Although patent and intellectual property disputes might be settled through licensing or similar arrangements, the costs associated with such arrangements may be substantial and could include our paying large fixed payments and ongoing royalties. Furthermore, the necessary licenses may not be available on satisfactory terms or at all.
Competitors may infringe our patents, and we may file infringement claims to counter infringement or unauthorized use. This can be expensive, particularly for a company of our size, and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover its technology. An adverse determination of any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly.
Also, a third party may assert that our patents are invalid and/or unenforceable. There are no unresolved communications, allegations, complaints or threats of litigation related to the possibility that our patents are invalid or unenforceable. Any litigation or claims against us, whether or not merited, may result in substantial costs, place a significant strain on our financial resources, divert the attention of management and harm our reputation. An adverse decision in litigation could result in inadequate protection for our product candidates and/or reduce the value of any license agreements we have with third parties.
Interference proceedings brought before the PTO may be necessary to determine priority of invention with respect to our patents or patent applications. During an interference proceeding, it may be determined that we do not have priority of invention for one or more aspects in our patents or patent applications and could result in the invalidation in part or whole of a patent or could put a patent application at risk of not issuing. Even if successful, an interference proceeding may result in substantial costs and distraction to our management.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or interference proceedings, there is a risk that some of our confidential information could be compromised by disclosure. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If investors perceive these results to be negative, the price of our common stock could be adversely affected.
If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and defend against litigation.
If our products, methods, processes and other technologies infringe the proprietary rights of other parties, we could incur substantial costs and we may have to: obtain licenses, which may not be available on commercially reasonable terms, if at all; abandon an infringing product candidate; redesign our products or processes to avoid infringement; stop using the subject matter claimed in the patents held by others; pay damages; and/or defend litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our financial and management resources.
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Risks Related to Technology and Intellectual Property
Our strategy includes an increasing dependence on technology in our operations. If any of our key technology fails, our business could be adversely affected.
Our operations are increasingly dependent on technology. Our information technology systems are critical to our ability to develop our products and otherwise operating our business. Problems with the operation of the information or communication technology systems we use could adversely affect, or temporarily disable, all or a portion of our operations. Further, any systems failures could impede our ability to timely collect and report financial results in accordance with applicable laws.
A cybersecurity incident could negatively impact our business and our relationships with our employees, service providers, patients, clinical study sites and government agencies.
We use information technology and operational technology assets, including computer and information networks, in substantially all aspects of our business operations. We also use mobile devices, social networking and other online activities to connect with our employees, service providers, patients, clinical study sites and government agencies. Such uses give rise to cybersecurity risks, including security breach, espionage, system disruption, theft and inadvertent release of information. Our business involves the storage and transmission of numerous classes of sensitive and/or confidential information and intellectual property, including clinical trial participants’ personal information, private information about employees and financial and strategic information about us and our business partners. If we fail to assess and identify cybersecurity threats, we may become increasingly vulnerable to such threats. Additionally, while we have implemented measures to prevent security breaches and cyber incidents, our preventive measures and incident response efforts may not be entirely effective. Also, the regulatory environment surrounding information security and privacy is increasingly demanding, with the frequent imposition of new and constantly changing requirements. This changing regulatory landscape may cause increasingly complex compliance challenges, which may increase our compliance costs. Any failure to comply with these changing security and privacy laws and regulations could result in significant penalties, fines, legal challenges and reputational harm. The theft, destruction, loss, misappropriation, or release of sensitive and/or confidential information or intellectual property, or interference with our information technology systems or the technology systems of third parties on which we rely, could result in business disruption, negative publicity, brand damage, violation of privacy laws, loss of confidence, potential liability and competitive disadvantage.
Risks Related to our Securities
The price of our common stock and warrants may be highly volatile.
The market price of our securities, like that of many other research and development public pharmaceutical and biotechnology companies, has been highly volatile and the price of our common stock and warrants may be volatile in the future due to a wide variety of factors, including:
| ● | announcements by us or others of results of pre-clinical testing and clinical trials; |
| ● | announcements of technological innovations, more important bio-threats or new commercial therapeutic products by us, our collaborative partners or our present or potential competitors; |
| ● | failure of our common stock to continue to be listed or quoted on a national exchange or market system, such as Nasdaq or the New York Stock Exchange; |
| ● | our quarterly operating results and performance; |
| ● | developments or disputes concerning patents or other proprietary rights; |
| ● | mergers or acquisitions; |
| ● | litigation and government proceedings; |
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| ● | adverse legislation; |
| ● | changes in government regulations; |
| ● | our available working capital; |
| ● | economic and other external factors; and |
| ● | general market conditions. |
Since January 1, 2017,2023, the closing stock price (split adjusted) of our common stock has fluctuated between a high of $5.08$7.65 per share to a low of $1.74$0.40 per share. On March 9, 20188, 2024, the last reported closing salessale price of our common stock on The Nasdaq Capital Market was $2.04$0.77 per share. Since January 1, 2017, the closing price of our common stock warrants has fluctuated between a high of $1.31 per warrant to a low of $0.21 per warrant. The fluctuation in the price of our common stock and warrants has sometimes been unrelated or disproportionate to our operating performance. In addition, potential dilutive effects of future sales of shares of common stock and warrants by us, as well as potential sale of common stock by the holders of warrants, options and options,convertible promissory notes, could have an adverse effect on the market price of our shares.
If we fail to meet Nasdaq’s listing requirements, we could be removed from The Nasdaq Capital Market, which would limit the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market and negatively impact our ability to raise capital.
The warrants do not confer any rightsCompanies trading on Nasdaq, such as our Company, must be reporting issuers under Section 12 of the Exchange Act, and must meet the listing requirements in order to maintain the listing of common stock ownership on The Nasdaq Capital Market. If we do not meet these requirements, the market liquidity for our securities could be severely adversely affected by limiting the ability of broker-dealers to sell our securities and the ability of shareholders to sell their holders, such as voting rights orsecurities in the right to receive dividends, but rather merely representsecondary market.
On June 23, 2023, we received a letter from the right to acquire sharesListing Qualifications Department of common stock at a fixedNasdaq stating that we were not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for a limited period of time. Specifically, commencingcontinued listing on the date of issuance, the holders of the warrants may exercise their right to acquire the common stock and pay $3.95 per share, prior to five years from the date of issuance, after which date any unexercised warrants will expire and have no further value.
The warrants may not have any value
Each warrant has an exercise price of $3.95 per share and will expire on the fifth anniversary of December 13, 2016. In the eventNasdaq Capital Market (the “Minimum Bid Price Rule”) because our common stock failed to maintain a minimum closing bid price of $1.00 for 30 consecutive trading days. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were afforded an initial period of 180 calendar days, or until December 20, 2023, to regain compliance with the Minimum Bid Price Rule. We were unable to regain compliance with the Minimum Bid Price Rule prior to the expiration of the 180 calendar day period.
On December 21, 2023, we received written notice from Nasdaq stating that we had not complied with the Minimum Bid Price Rule and were not eligible for a second 180-day period because we did not comply with the $5,000,000 minimum stockholders’ equity initial listing requirement for The Nasdaq Capital Market. In that regard, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 reported stockholders’ equity of $4,221,155. As a result, the notice indicated that our common stock would be suspended from trading on Nasdaq unless we requested a hearing before a hearings panel by December 28, 2023. Nasdaq has scheduled a hearing for March 26, 2024, which stayed any trading suspension of our common stock until completion of the Nasdaq hearing process and expiration of any additional extension period granted by the panel following the hearing.
There can be no assurance that we will be able to regain compliance with the Minimum Bid Price Rule prior to the hearing date or at all, that Nasdaq will grant us an extension of time to achieve compliance with the Minimum Bid Price Rule or that our common stock will remain listed on The Nasdaq Capital Market. If the hearing does not exceedresult in Nasdaq granting us an extension of time to achieve compliance with the exercise priceMinimum Bid Price Rule, our common stock will be delisted from Nasdaq.
If our common stock is delisted from Nasdaq, it will have material negative impact on the actual and potential liquidity of our securities, as well as material negative impact on our ability to raise future capital. If, for any reason, Nasdaq should delist our common stock from trading on its exchange and we are unable to obtain listing on another national securities exchange
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or take action to restore our compliance with the Nasdaq continued listing requirements, a reduction in some or all of the warrants during the period when the warrants are exercisable, the warrantsfollowing may notoccur, each of which could have any value.a material adverse effect on our shareholders:
| ● | the liquidity of our common stock; |
| ● | the market price of our common stock; |
| ● | our ability to obtain financing for the continuation of our operations; |
| ● | the number of institutional and general investors that will consider investing in our securities; |
| ● | the number of market makers in our common stock; |
| ● | the availability of information concerning the trading prices and volume of our common stock; and |
| ● | the number of broker-dealers willing to execute trades in shares of our common stock. |
Shareholders may suffer substantial dilution related to issued stock warrants, options and options.
convertible notes.
As of December 31, 2017,2023, we had a number of agreements or obligations that may result in dilution to investors. These include:
| ● | warrants to purchase a total of approximately |
| ● | options to purchase approximately |
| ● | convertible promissory notes issued to Pontifax Medison Finance, of which there was $3,000,000 of principal and $63,351 of accrued interest outstanding. The Convertible Notes were convertible at (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 588,599 shares issuable upon conversion at December 31, 2023 and (ii) $1.70 with respect to all shares issuable upon conversion in excess of the first 588,599 shares issued upon conversion at December 31, 2023. |
We also have an incentive compensation plan for our management, employees and consultants. We have granted, and expect to grant in the future, options to purchase shares of our common stock to our directors, employees and consultants. To the extent that warrants, options or optionsconvertible promissory notes are exercised or converted, our stockholders will experience dilution and our stock price may decrease.
Additionally, the sale, or even the possibility of the sale, of the shares of common stock underlying these warrants, options and optionsconvertible promissory notes could have an adverse effect on the market price for our securities or on our ability to obtain future financing.
Our shares of common stock and warrants are thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell shares or warrants to raise money or otherwise desire to liquidate their shares.
Our common stock and warrants havehas from time to time been “thinly-traded,” meaning that the number of persons interested in purchasing our common stock or warrants at or near ask prices at any given time may be relatively small or non-existent. This situation is attributable to a number of factors, including the fact that we are a small company that is relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we become more seasoned and viable. As a consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot give stockholders any assurance that a
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broader or more active public trading market for our common shares and warrants will develop or be sustained, or that current trading levels will be sustained.
Our common stock is deemed to be a “penny stock,” which may make it more difficult for investors to sell their shares due to suitability requirements.
Our common stock is subject to Rule 15g-1 through 15g-9 under the Exchange Act, which imposes certain sales practice requirements on broker-dealers which sell our common stock to persons other than established customers and “accredited investors” (generally, individuals with a net worth in excess of $1,000,000 or annual incomes exceeding $200,000 (or $300,000 together with their spouses)). For transactions covered by this rule, a broker-dealer must make a special suitability determination for the purchaser and have received the purchaser’s written consent to the transaction prior to the sale. This rule adversely affects the ability of broker-dealers to sell our common stock and the ability of our stockholders to sell their shares of common stock.
Additionally, our common stock is subject to SEC regulations for “penny stock.” The regulations require that prior to any non-exempt buy/sell transaction in a penny stock, a disclosure schedule set forth by the SEC relating to the penny stock market must be delivered to the purchaser of such penny stock. This disclosure must include the amount of commissions payable to both the broker-dealer and the registered representative and current price quotations for the common stock. The regulations also require that monthly statements be sent to holders of penny stock that disclose recent price information for the penny stock and information of the limited market for penny stocks. These requirements may adversely affect the market liquidity of our common stock.
We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common stock.
We have never declared or paid cash dividends on our common stock and do not anticipate paying any cash dividends to holders of our common stock in the foreseeable future. Consequently, our stockholders must rely on sales of their common stock and warrants after price appreciation, which may never occur, as the only way to realize any future gains on their investments. There is no guarantee that shares of our common stock or warrants will appreciate in value or even maintain the price at which our stockholders have purchased their shares.
Upon our dissolution, of the Company, our stockholders may not recoup all or any portion of their investment.
In the event of aour liquidation, dissolution or winding-up, of the Company, whether voluntary or involuntary, the proceeds and/or our assets of the Company remaining after giving effect to such transaction, and the payment of all of our debts and liabilities will be distributed to the holders of common stock on a pro rata basis. There can be no assurance that we will have available assets to pay to the holders of common stock, or any amounts, upon such a liquidation, dissolution or winding-up of the Company.winding-up. In this event, our stockholders could lose some or all of their investment.
The sale or issuance of our common stock to Lincoln Park may cause dilution and the sale of the shares of common stock acquired by Lincoln Park, or the perception that such sales may occur, could cause the price of our common stock to fall.
On March 22, 2016, we entered into a purchase agreement (the “2016 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant to the 2016 Purchase Agreement, Lincoln Park has committed to purchase up to $12 million of our common stock, of which approximately $10.2 million worth of our common stock remains issuable as of December 31, 2017. Concurrently with the execution of the 2016 Purchase Agreement, we issued 10,000 shares of our common stock to Lincoln Park as a partial fee for its commitment to purchase shares of our common stock under the 2016 Purchase Agreement. From March 22, 2016 through December 31, 2017, we sold 310,000 shares to Lincoln Park and issued 7,618 additional shares to Lincoln Park as additional commitment shares under the 2016 Purchase Agreement and received proceeds of $1,828,250. The shares that may be sold pursuant to the 2016 Purchase Agreement may be sold by us to Lincoln Park at our sole discretion from time to time over the remaining term of approximately 15 months from December 31, 2017, provided the registration statement registering the resale of shares sold to Lincoln Park under the 2016 Purchase Agreement remains effective. The purchase price for the shares that we may sell to Lincoln Park under the 2016 Purchase Agreement will fluctuate based on the price of our common stock. We have the right to control the timing and amount of any sales of our shares to Lincoln Park, except that, pursuant to the terms of our agreements with Lincoln Park, we would be unable to sell shares to Lincoln Park that would cause Lincoln Park to beneficially own more than 4.99% of our issued and outstanding common stock.
Depending on market liquidity at the time, sales of shares under the 2016 Purchase Agreement may cause the trading price of our common stock to fall. Additionally, further sales of our common stock, if any, to Lincoln Park under the 2016 Purchase Agreement will depend upon market conditions and other factors to be determined by us. Lincoln Park may ultimately purchase all, some or none of the shares of our common stock that may be sold pursuant to the 2016 Purchase Agreement and, after it has acquired shares, Lincoln Park may sell all, some or none of those shares. Therefore, sales to Lincoln Park by us could result in substantial dilution to the interests of other holders of our common stock. Additionally, the sale of a substantial number of shares of our common stock to Lincoln Park, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
The issuance of our common stock pursuant to the terms of the asset purchase agreement with Hy Biopharma Inc. may cause dilution and the issuance of such shares of common stock, or the perception that such issuances may occur, could cause the price of our common stock to fall.
On April 1, 2014, we entered into an option agreement pursuant to which Hy Biopharma granted us an option to purchase certain assets, properties and rights (the “Hypericin Assets”) related to the development of Hy Biopharma’s synthetic hypericin product candidate for the treatment of CTCL, which we refer to as SGX301,HyBryte™, from Hy Biopharma. In exchange for the option, we paid $50,000 in cash and issued 4,307288 shares of common stock in the aggregate to Hy Biopharma and its assignees. We subsequently exercised the option, and on September 3, 2014, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Hy Biopharma, pursuant to which we purchased the Hypericin Assets. Pursuant to the purchase agreement,Asset Purchase Agreement, we initially paid $275,000 in cash and issued 184,91212,328 shares of common stock in the aggregate to Hy Biopharma and its assignees, and the licensors of the license agreement acquired from Hy Biopharma, and may issue up to an aggregate of $10 million worth of our common stock (subject to a cap equal to 19.99% of our issued and outstanding common stock) in the aggregate upon attainment of specified milestones. The next milestone payment will be payable if the Phase 3 clinical trial of SGX301 is successful in demonstrating efficacy and safety in the CTCL patient population.Biopharma. Also, on September 3, 2014, we entered into a Registration Rights Agreement with Hy Biopharma, pursuant to which we have filedmay be required to file a registration statement with the SEC. In March 2020, we issued 130,413 shares of common stock at a value of $5,000,000 (based upon an effective per share price of $38.40 as a result of HyBryte™ demonstrating statistically significant treatment response in the Phase 3 clinical trial. We will be required to issue up to $5.0
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million worth of our common stock (subject to a cap equal to 19.9% of our issued and outstanding common stock) in the aggregate, if HyBryte™ is approved for the treatment of CTCL by either the FDA or the EMA.
The number of shares that we may issue under the purchase agreementAsset Purchase Agreement will fluctuate based on the market price of our common stock. Depending on market liquidity at the time, the issuance of such shares may cause the trading price of our common stock to fall.
We may ultimately issue all, some or none of the additional shares of our common stock that may be issued pursuant to the purchase agreement.Asset Purchase Agreement. We are required to register any shares issued pursuant to the purchase agreement for resale under the Securities Act of 1933, as amended.amended (the “Securities Act”). After any such shares are registered, the holders will be able to sell all, some or none of those shares. Therefore, issuances by us under the purchase agreement could result in substantial dilution to the interests of other holders of our common stock. Additionally, the issuance of a substantial number of shares of our common stock pursuant to the purchase agreement,Asset Purchase Agreement, or the anticipation of such issuances, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
Repayment of certain convertible notes, if they are not otherwise converted, will require a significant amount of cash, and we may not have sufficient cash flow from our business to make payments on our indebtedness.
Our ability to pay the principal of and/or interest on the convertible notes issued pursuant to the Loan and Security Agreement with Pontifax Medison Finance (the “Convertible Notes”) depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. Our business may not generate cash flow from operations in the future sufficient to service the Convertible Notes or other future indebtedness and make necessary capital expenditures. If we are unable to generate such cash flow, we may be required to adopt and implement one or more alternatives, such as selling assets, restructuring indebtedness or obtaining additional debt financing or equity financing on terms that may be onerous or highly dilutive. Our ability to refinance the Convertible Notes or other future indebtedness will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations, including the Convertible Notes.
The issuance of shares of common stock upon conversion of the Convertible Notes could substantially dilute shareholders’ investments and could impede our ability to obtain additional financing.
The Convertible Notes are convertible into shares of our common stock and give the holders an opportunity to profit from a rise in the market price of our common stock such that conversion or exercise thereof could result in dilution of the equity interests of our shareholders. As of March 8, 2024, there was $2,900,858 of principal and $45,840 of accrued interest outstanding under the Convertible Notes. We have no control over whether the holders will exercise their right to convert their Convertible Notes. While the Convertible Notes are convertible at (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 442,400 shares issuable upon conversion as of March 8, 2024 and (ii) $1.70 with respect to all shares issuable upon conversion in excess of the first 442,400 shares issued upon conversion as of March 8, 2024, we cannot predict the market price of our common stock at any future date, and therefore, cannot predict whether the Convertible Notes will be converted. We also may choose to reduce the conversion price of the Convertible Notes, which would likely cause the Convertible Notes to be converted into a significant amount of our common stock and reduce our liabilities. The existence and potentially dilutive impact of the Convertible Notes may prevent us from obtaining additional financing in the future on acceptable terms, or at all.
Our Board of Directors can, without stockholder approval, cause preferred stock to be issued on terms that adversely affect holders of our common stock.
Under our Certificate of Incorporation, our Board of Directors is authorized to issue up to 230,000 shares of preferred stock, of which none are issued and outstanding as of the date of this prospectus. Also, our Board of Directors, without stockholder approval, may determine the price, rights, preferences, privileges and restrictions, including voting rights, of those shares. If our Board of Directors causes shares of preferred stock to be issued, the rights of the holders of our common stock would likely be subordinate to those of preferred holders and therefore could be adversely affected. Our Board of Directors’ ability to determine the terms of preferred stock and to cause its issuance, while providing desirable flexibility in connection with possible acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire a majority of our outstanding common stock. Preferred shares issued by our Board of Directors could include voting
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rights or super voting rights, which could shift the ability to control the Company to the holders of the preferred stock. Preferred stock could also have conversion rights into shares of our common stock at a discount to the market price of our common stock, which could negatively affect the market for our common stock. In addition, preferred stock would have preference in the event of liquidation of the Company, which means that the holders of preferred stock would be entitled to receive the net assets of the Company distributed in liquidation before the holders of our common stock receive any distribution of the liquidated assets.
Item 1B. Unresolved Staff Comments
None.
Item 1C. Cybersecurity
Cybersecurity Risk Management and Strategy
Our technology and cybersecurity programs are crucial to maintaining secure operations, which enable us to deliver on our promise to maintain stakeholder trust. Our Chief Financial Officer is responsible for establishing, implementing and executing our cybersecurity program and strategy. Our CFO has over eight years of information technology, information technology audit, and cybersecurity experience, and is involved in following the latest developments in cybersecurity, including potential threats and innovative risk management techniques.
Our cybersecurity program is a critical component of our enterprise risk management process overseen by our Board of Directors, and we have integrated cybersecurity-related risks into our overall enterprise risk management framework. Additionally, cybersecurity-related risks are included in the risk universe that the risk management function evaluates to assess top risks to the enterprise on an annual basis.
Our personnel responsible for cybersecurity proactively identifies, manages, and mitigates cyber risk in a variety of ways, including but not limited to:
| a. | A formal enterprise-wide cybersecurity policy and related standards; |
| b. | Cybersecurity training and employee phishing simulations; |
| c. | Scheduled and ad hoc internal and external penetration tests; |
| d. | Cyber incident response, IT disaster recovery, and business continuity plans; |
| e. | Cybersecurity assessments and remediation planning as part of our due diligence process; |
| f. | Identity and access management controls; |
| g. | Third-party risk assessment and management for vendors and third-party service providers; and |
| h. | Cyber incident exercises for our Board of Directors and management. |
A primary element of our cybersecurity program is the implementation of controls that are aligned with industry guidelines and applicable regulations to identify threats, deter attacks, and protect our information security assets. We have procedures in place for selecting and managing our relationships with third-party service providers and other business partners, including to monitor compliance with our agreements and regulatory and legal requirements. We also actively engage with industry participants as part of our continuing efforts to evaluate and enhance the effectiveness of our information security policies and procedures.
Our cybersecurity program is designed based on the concepts of control maturity and control efficacy. For control maturity, our cybersecurity program is aligned to the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework (“CSF”) and is assessed annually by an independent third party against our yearly control maturity targets in the context of current cyber threat and industry trends. The NIST CSF assessment results are used to validate the progress made against the current year maturity targets, inform the program’s strategic priorities and establish maturity targets for the following year. These assessment results are provided to our Board of Directors on an annual basis.
For control efficacy, the cybersecurity program leverages a variety of metrics and measurements to demonstrate whether the control objectives are being consistently achieved within the target range. Monthly security operation (“SecOps”) reviews are utilized to monitor metric trends and root causes to determine potential capability improvements. The monthly SecOps reviews and related actions are aggregated into a subset of key metrics reviewed quarterly by the Board of Directors.
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Cybersecurity Governance
Our Board of Directors oversees the management of our cybersecurity risk exposures and the steps management has taken to monitor and control such exposures. At each quarterly meeting, the Board of Directors receives an update from our CFO and other members of management on relevant topics, including cybersecurity program maturity progress, new capabilities implemented, penetration testing results, key cyber risk metrics (e.g., simulated phishing testing and vulnerability management) and notable incidents or events should they occur. On an annual basis, our Board of Directors meets with our CFO and our third-party cybersecurity consultant to review our cybersecurity strategy and the results of our NIST CSF assessment. In accordance with our cybersecurity incident response plan, our Board of Directors is promptly informed of potentially material cybersecurity incidents, including with respect to our third-party service providers.
Although we have experienced cybersecurity incidents from time to time that have not had a material adverse effect on our business, financial condition, or results of operations, there can be no assurance that a cyber-attack, security breach, or other cybersecurity incident will not have a material adverse effect on us in the future. For a discussion regarding risks from cybersecurity threats that have or are reasonably likely to affect us, see our risk factors, including the risk factors titled “Our strategy includes an increasing dependence on technology in our operations. If any of our key technology fails, our business could be adversely affected.” and “A cybersecurity incident could negatively impact our business and our relationships with employees, service providers, patients, clinical study sites and government agencies.” in Item 1A of this Annual Report on Form 10-K.
We currently lease approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey pursuant to a lease that was amended in October 2017 and expires in October 2020.Jersey. This office space currently serves as our corporate headquarters.headquarters, and both of our business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. Pursuant to an amendment on June 21, 2022, the lease has been extended from November 2022 to October 2025. The current rent for the first 12 months is approximately $11,367 per month or approximately $22.00 per square foot.and will remain so through October 2024. The rent will increase tofor the lease period starting November 2024 is approximately $11,625 per month, or approximately $22.50 per square foot, for the next 12 months and increase to approximately $11,883 per month, or approximately $23.00 per square foot for the remainder of the lease.month. Our office space is sufficient to satisfyfor our current needs. We may add new space or expand existing space as we add employees, and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.
None.
From time to time, we are a party to claims and legal proceedings arising in the ordinary course of business. Our management evaluates our exposure to these claims and proceedings individually and in the aggregate and allocates additional monies for potential losses on such litigation if it is possible to estimate the amount of loss and if the amount of the loss is probable.
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PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Our common stock is quotedtraded on theThe Nasdaq Capital Market under the symbol “SNGX.” The following table sets forth as adjusted for the reverse stock split of one-for-ten effective October 7, 2016, for the periods indicated, the high and low sales prices per share of our common stock for the periods indicated, as reported by the OTCQB through December 12, 2016 and theThe Nasdaq Capital Market.
| | | | | | |
|
| Price Range | ||||
Period |
| High |
| Low | ||
Year Ended December 31, 2022: |
| |
|
| |
|
First Quarter | | $ | 13.65 | | $ | 8.70 |
Second Quarter | | $ | 12.00 | | $ | 5.70 |
Third Quarter | | $ | 15.00 | | $ | 6.45 |
Fourth Quarter | | $ | 10.95 | | $ | 5.85 |
Year Ended December 31, 2023: | |
|
| |
|
|
First Quarter | | $ | 8.10 | | $ | 1.75 |
Second Quarter | | $ | 4.20 | | $ | 0.64 |
Third Quarter | | $ | 0.74 | | $ | 0.42 |
Fourth Quarter | | $ | 2.00 | | $ | 0.38 |
Our stock is listed on The Nasdaq Capital Market beginning with our uplisting tounder the symbol “SNGX.” The Nasdaq and trading on December 13, 2016.
| Price Range | ||||||||
| Period | High | Low | ||||||
| Year Ended December 31, 2016: | ||||||||
| First Quarter | $ | 12.50 | $ | 6.20 | ||||
| Second Quarter | $ | 9.00 | $ | 6.20 | ||||
| Third Quarter | $ | 8.50 | $ | 5.60 | ||||
| Fourth Quarter | $ | 8.11 | $ | 2.05 | ||||
| Year Ending December 31, 2017: | ||||||||
| First Quarter | $ | 3.18 | $ | 1.90 | ||||
| Second Quarter | $ | 5.08 | $ | 2.00 | ||||
| Third Quarter | $ | 2.99 | $ | 1.98 | ||||
| Fourth Quarter | $ | 2.61 | $ | 1.74 | ||||
On March 9, 2018, the last reported price of our common stock quoted on the Nasdaq was $2.04 per share. The NasdaqCapital Market prices set forth above represent inter-dealer quotations, without adjustment for retail mark-up, mark-down or commission, and may not represent the prices of actual transactions. Our stock is listed on the Nasdaq capital market under the under the symbol “SNGX.” On December 13, 2016, our common stock warrants began trading on the Nasdaq Capital Market under the symbol “SNGXW”. For the period December 13, 2016 through the fourth quarter ended December 31, 2017, the high and low sales price per warrant as reported by Nasdaq were $1.31 and $0.21 respectively. On March 9, 2018,8, 2024, the last reported price of our common stock warrantsquoted on The Nasdaq Capital Market was $0.63$0.77 per warrant.share.
Unregistered Sales of Equity Securities
Other than as previously reported, we did not issue any unregistered shares during the year ended December 31, 2023. We issued a total of 146,199 shares of common stock to two lenders upon conversion of approximately $100,000 of principal under promissory notes at a conversion price of $0.68 on January 3, 2024. Such promissory notes may be converted at (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 442,400 shares issuable upon conversion as of March 8, 2024 and (ii) $1.70 with respect to all shares issuable upon conversion in excess of the first 442,400 shares issued upon conversion as of March 8, 2024.
The issuance of common stock as described above was exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The recipients are knowledgeable, sophisticated and experienced in making investment decisions of this kind and received adequate information about us or had adequate access to information about us.
Transfer Agent
The transfer agent and registrar forShares of our common stock and warrants is American Stock Transfer &are issued in registered form. Equiniti Trust Company, LLC. The address isLLC, 6201 15th Avenue, Brooklyn, NY 11219 (Telephone: (718) 921-8200; Facsimile: (718) 765-8719) is the registrar and the telephone number is (718) 921-8200.
transfer agent for shares of our common stock.
Holders of Common Stock
As of March 9, 2018,8, 2024, there were 257112 holders of record of our common stock. As of such date, 8,740,72310,524,437 shares of our common stock were issued and outstanding.
Dividends
We have never declared nor paid any cash dividends, and currently intend to retain all our cash and any earnings for use in our business and, therefore, do not anticipate paying any cash dividends in the foreseeable future. Any future determination to pay cash dividends will be at the discretion of the Board of Directors and will be dependent upon our
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consolidated financial condition, results of operations, capital requirements and such other factors as the Board of Directors deems relevant.
Item 6. Selected Financial Data
Not applicable.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Cautionary Note Regarding Forward-Looking Statements
This Annual Report on Form 10-K contains forward-looking statements that reflect our current expectations about our future results, performance, prospects and opportunities. These forward-looking statements are subject to significant risks, uncertainties, and other factors, including those identified in “Risk Factors” above, which may cause actual results to differ materially from those expressed in, or implied by, any forward-looking statements. The forward-looking statements within this Form 10-K may be identified by words such as “believes,” “anticipates,” “expects,” “intends,” “may,” “would,” “will” and other similar expressions. However, these words are not the exclusive means of identifying these statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Except as expressly required by the federal securities laws, we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances occurring subsequent to the filing of this Form 10-K with the SEC or for any other reason. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the SEC that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.
Our Business Overview
We are a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. We maintain two active business segments: Specialized BioTherapeutics and Vaccines/BioDefense.
Public Health Solutions.
Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy (SGX301)(“PDT”), utilizing topical synthetic hypericin activated with safe visible fluorescent light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the Phase 3 FLASH (Fluorescent Light And Synthetic Hypericin) study, regulatory approval is being pursued in the U.S. and Europe. Following submission of a new drug application (“NDA”) for HyBryte™ in the treatment of CTCL, we received a refusal to file (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”). We had a Type A meeting with the FDA to clarify and respond to the issues identified in the RTF letter and to seek additional guidance concerning information that the FDA would require for a resubmitted NDA to be deemed acceptable to file, in order to advance HyBryte™ towards U.S. marketing approval and commercialization. In order to accept an NDA filing for HyBryte™, the FDA is requiring positive results from a second, Phase 3 pivotal study in addition to the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication. Based on this feedback, we are collaboratively engaging in active discussions with both the FDA and the European Medicines Agency (“EMA”) in order to define the protocol and evaluate the feasibility of conducting the additional Phase 3 clinical trial evaluating HyBryte™ in the treatment of CTCL in support of potential marketing approval.
Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulatorInnate Defense Regulator (“IDR”) technology, and dusquetide (SGX942)(SGX942 and SGX945) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and proprietary formulations of oral beclomethasone 17,21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).aphthous ulcers in Behçet’s Disease.
Our Vaccines/BioDefensePublic Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome (“GI ARS”) therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease.disease and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs currently is supported byincorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®, under existing. To date, this business segment has been supported with government grant and on-going government contract funding. With the government contractfunding from the National Institute of Allergy and Infectious Diseases, (“NIAID”), we will attempt to advance the development of RiVax® to protect against exposure to ricin toxin. We have advanced the development of OrbeShield® for the treatment of GI ARS with funds received under our awarded government contracts with the Biomedical Advanced Research and Development Authority (“BARDA”) and grants from NIAID.
the Defense Threat Reduction Agency.
An outline of our business strategy follows:
| ● |
| ● | Expanding development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients. |
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| ● | Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency (“MHRA”) that a second Phase 3 clinical trial of |
| ● | Expanding development of dusquetide under the research name SGX945 into Behçet’s Disease with the conduct of a Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. |
| ● | Continue development of |
| ● | ||
| Continue to apply for and secure additional government funding for each of our Specialized BioTherapeutics and |
| ● | Pursue business development opportunities for |
| ● | Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development. |
Corporate Information
We were incorporated in Delaware in 1987 under the name Biological Therapeutics, Inc. In 1987, we merged with Biological Therapeutics, Inc., a North Dakota corporation, pursuant to which we changed our name to “Immunotherapeutics, Inc.” We changed our name to “Endorex Corp.” in 1996, to “Endorex Corporation” in 1998, to “DOR BioPharma, Inc.” in 2001, and finally to “Soligenix, Inc.” in 2009. Our principal executive offices are located at 29 Emmons Drive, Suite B-10, Princeton, New Jersey 08540 and our telephone number is (609) 538-8200.
Our Product Candidates in Development
The following tables summarize our product candidates under development:
Specialized BioTherapeutics Product Candidates
| | | | |
|---|---|---|---|---|
Soligenix Product Candidate | Therapeutic Indication | Stage of Development | ||
HyBryte™ | | Cutaneous T-Cell Lymphoma | | Phase 2 trial completed; demonstrated significantly higher response rate compared to placebo; Phase 3 trial completed; demonstrated statistical significance in primary endpoint in March 2020 (Cycle 1) and demonstrated continued improvement in treatment response with extended treatment in April 2020 (Cycle 2) and October 2020 (Cycle 3); NDA submitted December 2022; FDA RTF letter received February 2023; Type A meeting with the FDA convened April 2023, in which the FDA determined that a second positive Phase 3 study would be required to support a NDA submission; actively engaged in formal protocol discussions with both the FDA and the EMA to define the protocol for, and evaluate feasibility of conducting, an additional Phase 3 clinical trial (as requested by the FDA); final outcome of |
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| | | | |
|---|---|---|---|---|
Soligenix Product Candidate | Therapeutic Indication | Stage of Development | ||
these discussions anticipated in the first half of 2024 | ||||
| | | | |
SGX302 | | Mild-to-Moderate Psoriasis | | Positive proof-of-concept demonstrated in a small Phase 1/2 pilot study; Phase 2a protocol and Investigation New Drug (“IND”) clearance received from the FDA; Phase 2a study remains ongoing having demonstrated biological effect in Cohort 1 and clinically meaningful benefit in Cohort 2 |
| | | | |
SGX942† | | Oral Mucositis in Head and Neck Cancer | | Phase 2 trial completed; demonstrated significant response compared to placebo with positive long-term (12 month) safety also reported; Phase 3 clinical trial results announced December 2020: The primary endpoint of median duration of severe oral mucositis (“SOM”) did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group; analyzed full dataset from Phase 3 study and designing a second Phase 3 clinical trial; continued development contingent upon identification of partnership |
| | | | |
SGX945 | | Aphthous Ulcers in Behçet’s Disease | | Phase 2a protocol and IND clearance received from the FDA; Phase 2a study to be initiated in the second half of 2024 |
Public Health Solutions†
| | | | | | ||
Soligenix Product Candidate | Indication | Stage of Development | |||||
ThermoVax® | | Thermostability of vaccines for Ricin toxin, Ebola, and Marburg viruses | Pre-clinical | ||||
| | | | | |||
RiVax® | | Vaccine against Ricin Toxin Poisoning | | Phase 1a, 1b and 1c trials completed, safety and neutralizing antibodies for protection demonstrated | |||
| | | | | | ||
SGX943 | | Therapeutic against Emerging Infectious Diseases | | Pre-clinical | |||
† | Contingent upon continued government contract/grant funding or other funding source. |
Critical Accounting Policies
Our management’s discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of theseour financial statements and related disclosures requires us to make estimates and judgmentsassumptions that affect the reported amounts of assets and liabilities, costs and expenses and relatedthe disclosure of contingent assets and liabilities. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and
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assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in the notes to our financial statements appearing at the end of this Annual Report on Form 10-K, we believe that the following accounting policies are those most critical to the assumptions and judgments on an on-going basis.estimates used in the preparation of our financial statements.
Revenue Recognition
Our revenues are primarilyinclude revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when we incur reimbursable internal expenses that are related to the government contracts and grants.
We also record revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as license revenues. Sales-based royalties under our license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, we have not recognized any royalty revenue.
Research and Development Costs
Research and development costsAs part of the process of preparing our financial statements, we are chargedrequired to expense when incurred in accordance with FASB ASC 730,Research and Development. Research and development includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. Purchased in-processestimate our accrued research and development expense representsexpenses. This process involves reviewing open contract and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the value assignedlevel of service performed and the associated costs incurred for the services when we have not yet been invoiced or paidotherwise notified of the actual costs. The majority of our service providers invoice us in arrears for acquiredservices performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development for which there is no alternative future use asexpenses include fees paid to:
| ● | contract research organizations (“CROs”) in connection with performing research activities on our behalf and conducting preclinical studies and clinical trials on our behalf; |
| ● | investigative sites or other service providers in connection with clinical trials; |
| ● | vendors in connection with preclinical and clinical development activities; and |
| ● | vendors related to product manufacturing and distribution of preclinical and clinical supplies. |
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We base our expenses related to preclinical studies and clinical trials on our estimates of the dateservices received and efforts expended pursuant to quotes and contracts with multiple CROs that conduct and manage preclinical studies and clinical trials on our behalf. The financial terms of acquisition.
Accounting for Warrants
We considered FASB ASC 815,Evaluating Whether an Instrument is Considered Indexedthese agreements are subject to an Entity’s Own Stock,negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which provides guidance for determining whether an equity-linked financial instrument (or embedded feature) issued by an entity is indexedpayments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing fees, we estimate the time period over which services will be performed, enrollment of patients, number of sites active and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or amount of prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the entity’s stockactual status and therefore, qualifying for the first parttiming of the scope exceptionservices performed may vary and may result in paragraph 815-10-15. We evaluated the provisions and determinedus reporting amounts that warrants issuedare too high or too low in connection with our June 2013 registered public offering contained provisions that protected holders from a decline in the issue price of our common stock (or “down-round” provisions) and contained net settlement provisions. Consequently, these warrants were recognized as liabilities at their fair value on theany particular period. To date, of grant and remeasured at fair value on each reporting date. During the year ended December 31, 2016, we entered into amendments with the holders of those warrants, and as a result the warrants were then reclassified to equity as the amended terms of the warrants qualified them to be accounted for as equity instruments. All other warrants that have been issued by us were indexednot made any material adjustments to our own stockprior estimates of accrued research and therefore were accounted for as equity instruments.development expenses.
Share-Based Compensation
Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. Stock options vest over each three-month period from the date of issuance to the end of the three year period. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position the options will expire within three months, unless otherwise extended by the Board.
From time to time, we issue restricted shares of common stock to vendors and consultants as compensation for services performed. Typically these instruments vest upon issuance and therefore the entire share-based compensation expense is recognized upon issuance to the vendors and/or consultants.
Share-based compensation expense for options, warrants and shares of common stock granted to non-employees has been determined in accordance with FASB ASC 505-50,Equity-Based Payments to Non-Employees, and represents the fair value of the consideration received, or the fair value of the equity instruments issued, whichever may be more reliably measured. For options that vest over future periods, the fair value of options granted to non-employees is amortized as the options vest. The fair value is remeasured each reporting period until performance is complete.
The fair value of each option grant made during 2017 and 2016 was estimated on the date of each grant using the Black-Scholes option pricing model and amortized ratably over the option vesting periods, which approximates the service period.
Income Taxes
On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the "Tax Act"). The Tax Act significantly revises U.S. corporate income taxation by, among other things, lowering the U.S. corporate income tax rate from 35.0 % to 21.0% effective January 1, 2018. The Company does not anticipate any impact to tax expense due to the full valuation allowance on its deferred tax assets and believes that the most significant impact on its consolidated financial statements will be reduction of approximately $14 million for the deferred tax assets related to net operating losses and other assets. Such reduction is fully offset by changes to the Company’s valuation allowance.
Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. No current or deferred income taxes have been provided through September 30, 2017 due to the net operating losses incurred by the Company since its inception. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for 2017 and 2016. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2017 and December 31, 2016.
Earnings Per Share
Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income (loss) available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented.
Use of Estimates and Assumptions
The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of warrants and stock options and recovery of the useful life of intangiblesto accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates.
Material Changes in Results of Operations
Year Ended December 31, 20172023 Compared to 2016
2022
For the year ended December 31, 2017,2023, we had a net loss of $7,147,083$6,140,730 as compared to a net loss of $3,245,383$13,798,339 for the prior year, representing an increaseddecreased net loss of $3,901,700$7,657,609 or 120%55%. IncludedThe decrease in the net loss for December 31, 2016 is the changeprimarily attributed to decreases in the fair value of the warrant liability related to warrants issued in connection with our June 2013 registered public financing of $1,541,241operating expenses and interest expense as well as an increase in other income. The warrant liability for the unexercised warrants was reclassified to equity in November 2016 as the price protection provision was eliminated through an amendment.
For the year ended December 31, 2017 and 2016, revenues and associated costs related to government contracts and grants awarded in support of our development of OrbeShield® for the treatment of GI ARS and RiVax® and other development programs. For the year ended December 31, 2017,2023, we had revenues of $5,432,472$839,359 as compared to $10,448,794$948,911 for the prior year, representing a decrease of $5,016,322$109,552 or 48%12%. The decrease in revenues was primarily a result of the completionrecognition of the NIAID contract for OrbeShield®during the first quarter of 2017, along with the expiration of the base period of the BARDA contract for the development of OrbeShield®, with BARDA electing not to extend the current contract beyond the base period. This waslicensing revenue in 2022 partially offset by an increase in grant revenues awarded in September 2017 to support the development of SGX301for the treatment of CTCL and SGX942 for the treatment of oral mucositis in head and neck cancer.revenue during 2023.
We incurred costs related to contract and grant revenues in the year ended December 31, 20172023 and 20162022 of $4,310,083$742,048 and $8,433,671,$550,822, respectively, representing a decreasean increase of $4,123,588$191,226 or 49%35%. The decreaseincrease in costs was primarily the result of an increase in costs relating to the decrease in revenues from the completion of the NIAID and BARDA contracts for the development of OrbeShield®.
HyBryte™ investigator-initiated study.
Our gross profit for the year ended December 31, 20172023 was $1,122,389$97,311 or 21%,12% of total revenues as compared to $2,015,123$398,089 or 19%42% of total revenues for the prior year, representing a decrease of $892,734$300,778 or 44%76%. The decrease in gross profit is consistent with our decrease in total revenues. The increase in gross profit percentage of 2% for the year ended December 31, 2017 as compared to December 31, 2016, was primarily attributable tothe result of the recognition of higher amounts of reimbursementmargin licensing revenue in 2017 for certain contractor2022 and employee expenses from contracts and grants, as well as management and administrative fees from the two grants awarded in 2017 in support of our pivotal Phase 3 trials of SGX301 and SGX942.
lower margin grant revenue associated with the HyBryte™ investigator-initiated study during 2023.
Research and development expenses increaseddecreased by $1,211,166$4,631,390 or 28%,58% to $5,507,033$3,312,699 for the year ended December 31, 20172023 as compared to $4,295,867$7,944,089 for the prior year. The increasedecrease in research and development spending for the year ended December 31, 20172023 was primarily related to expenditures incurredthe decrease in manufacturing and regulatory costs associated with the preparation and initiation of the Phase 3 clinical trial of SGX942 as well as the ongoing Phase 3 clinical trial of SGX301.
HyBryte™ NDA filing.
General and administrative expenses decreased $219,683by $2,210,352 or 6%33%, to $3,209,155$4,482,552 for the year ended December 31, 2017,2023, as compared to $3,428,838$6,692,904 for the prior year. This decrease is primarily related to a decreasereduction in professional fees.legal and consulting expenses.
The amendment to the convertible debt financing agreement with Pontifax Medison Finance (“Pontifax”) – see Note 5 –, resulted in the extinguishment of the original convertible debt for accounting purposes. We elected to account for the amended convertible debt using the fair value option, which requires us to record changes in fair value as a component of other income or expense. The fair value of the convertible debt on the date of the amendment was approximately $3,304,000, which resulted in the recognition of a loss on extinguishment of approximately $394,000 on our accompanying consolidated statements of operations during the year ended December 31, 2023. The fair value of the convertible debt as of December 31, 2023 was approximately $3,260,934, which resulted in the recognition of $43,066 of other income from
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the change in the fair value of the convertible debt on our accompanying consolidated statements of operations during the year ended December 31, 2023. The fair value of the convertible debt was estimated using the Monte Carlo valuation method.
Other incomeTotal other expense for the year ended December 31, 20172023 was $29,906$210,593 as compared to $1,934,056$714,370 of total other expense for the prior year, reflecting a decrease of $1,904,150$503,777 or 98%71%. The decrease isin total other expense was primarily due toassociated with the changereduction in interest resulting from the fair valuerepayment of a portion of the warrant liability resulting in $1,541,241 of otherconvertible debt principal balance and higher interest income in 2016. In addition, $390,599 was included in other income in 2016 related to an amount that had previously been accrued. We were notified that the amount was no longer considered outstanding by the counterparty and therefore reversed the amount accrued, resulting in other income.
earned on cash balances.
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused net operating loss (“NOL”)NOL carryforwards to other New Jersey-based corporate taxpayers. In accordance with this program, for the year ended December 31, 2017, weWe sold 2022, 2021 and 2020 New Jersey NOL carryforwards resulting in the recognition of $416,810 of income tax benefit as compared to $530,143benefits, net of transaction costs of $1,767,803 and $1,154,935 during the years ended December 31, 2023 and 2022, respectively. We sold our 2022 New Jersey NOLs and have recorded a receivable of $606,606 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2016. As of December 31, 2017, payment of the $416,810 from the sale of the2023. We have not yet sold our 2023 New Jersey NOL carryforward was outstanding. Accordingly, we recorded this amount as a current income tax receivable, and subsequently received paymentcarryforwards but may do so in January 2018. Therethe future. We will continue to explore opportunities to sell unused NOL carryforwards for the year ended December 31, 2023. However, there can be no assurance as to the continuation or magnitude of this program in future years.
Business Segments
We maintain two active business segments for the years ended December 31, 20172023 and 2016: Vaccines/BioDefense2022: Specialized BioTherapeutics and BioTherapeutics.Public Health Solutions.
The Specialized BioTherapeutics business segment had revenue of $395,124 for the year ended December 31, 2023 as compared to $31,929 for the year ended December 31, 2022, representing an increase of $363,195 or 100%. The increase was due to increased reimbursable development activity under the grant to support the investigator-initiated study of HyBryte™ for expanded treatment in patients with early-stage CTCL.
Revenues for the Vaccines/BioDefensePublic Health Solutions business segment for the year ended December 31, 20172023 were $4,749,294$444,235 as compared to $10,448,794$916,982 for the year ended December 31, 2016,2022, representing a decrease of $5,699,500$472,747 or 55%52%. The decrease in revenues was aprimarily the result of the completionrecognition of licensing revenue in 2022 and the conclusion of the NIAID contract duringgrant associated with the first quarterdevelopment of 2017, along withSGX943.
Loss from operations for the Public Health Solutions business segment for the year ended December 31, 2023 was $36,531 as compared to income from operations of $26,612 for the year ended December 31, 2022, representing a decrease of $63,143 or 237%. The loss for the year ended December 31, 2023 is attributable to the recognition of licensing revenue in 2022 and additional expenses incurred due to the expiration of the base period BARDA contractgrants and contracts. Loss from operations for the development of OrbeShield®, with BARDA electing not to extend the current contract beyond the base period. Revenues for theSpecialized BioTherapeutics business segment for the year ended December 31, 2017 were $683,1782023 was $2,812,303 as compared to $0$7,614,988 for the year ended December 31, 2016, due2022, representing a decreased loss of $4,802,685 or 63%. This decreased loss is primarily attributed to the two grants awarded in 2017 in support of our pivotal Phase 3 trials of SGX301 and SGX942.
Income from operations for the Vaccines/BioDefense business segment for the year ended December 31, 2017 was $232,166 as compared to $1,563,884 for the year ended December 31, 2016. Income from operations is primarily attributable to our gross margins related to our government contracts. Loss from operations for the BioTherapeutics business segment for the year ended December 31, 2017 was $4,181,811 as compared to $3,399,933 for the year ended December 31, 2016, representing an increase of $781,878 or 23%. This increased loss is due primarily to expenses incurred in the preparation and initiation of the pivotal Phase 3 clinical trial of SGX942 as well as the ongoing Phase 3 clinical trial of SGX301.
Amortization and depreciation expense for the Vaccines/BioDefense business segment for the year ended December 31, 2017 was $33,183 as compared to $40,186 for the year ended December 31, 2016. Amortization and depreciation expense for the BioTherapeutics business segment for the year ended December 31, 2017 was $30,614 as compared to $41,395 for the year ended December 31, 2016. The decrease in amortizationmanufacturing and depreciation expense wasregulatory costs associated with the result of patents becoming fully amortized during the year ended December 31, 2017.HyBryte™ NDA filing.
Financial Condition and Liquidity
Cash and Working Capital
As of December 31, 2017,2023, we had cash and cash equivalents of $7,809,487$8,446,158 as compared to $8,772,567$13,359,615 as of December 31, 2016,2022, representing a decrease of $963,080$4,913,457 or 11%37%. As of December 31, 2017,2023, we had working capital of $6,185,863$3,355,212, representing an increase of $6,018,933 as compared to a working capital deficit of $7,243,918, representing a decrease of $1,058,055 or 15%.($2,663,721) for the prior year. The decrease in cash and cash equivalents andwas primarily related to cash used in operating activities. The increase in working capital is primarily relatedthe result of the net proceeds received from financing activities partially offset by the immediate paydown of $5 million of outstanding debt principal balance and any accrued interest resulting from the amendment to expendituresthe convertible debt financing agreement with Pontifax during the year ended December 31, 2023.
We believe that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations as they become due into the pivotal Phase 3 clinical trialfourth quarter of SGX301 for the treatment of CTCL2024. We do not have sufficient cash and expenditures incurred in the preparation and initiationcash equivalents as of the Phase 3 clinical trialdate of SGX942filing this Annual Report on Form 10-K to support our operations for at least the treatment12 months
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following the date the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the date that the financial statements are issued.
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional capital, potentially through a combination of public or private equity offerings and neck cancer.
Based on our current rate of cash outflows, cash on hand,strategic transactions, including potential alliances and drug product collaborations, securing additional proceeds from government contract and grant programs, securing additional proceeds available from the equity linesale of shares of our common stock via an At Market Issuance Sales Agreement and potentially amending the loan agreement with Lincoln Park Capital, LLC, and proceeds fromPontifax to reduce the Stateconversion price in order to allow for conversion of New Jersey Technology Business Tax Certificate Transfer Program, management believesa portion of the debt which will reduce our debt repayments; however, none of these alternatives are committed at this time. There can be no assurance that its current cashwe will be successful in obtaining sufficient funding on terms acceptable to meetus to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the anticipatedcapital that we will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about our ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, we will not have sufficient cash needs for working capitalresources and capital expendituresliquidity to fund our business operations for at least the next twelve12 months from issuance offollowing the date the financial statements.statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce our ability to access capital, which could negatively affect our liquidity and ability to continue as a going concern. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
Our plans with respect to our liquidity management include, but are not limited to, the following:
| ● | We have up to |
| ● | We have continued to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expect to continue to do so for the foreseeable future; |
| ● | We will continue to pursue NOL sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer |
| ● | We plan to pursue potential partnerships for |
| ● | We completed a public offering of 2,301,500 shares of our common stock, pre-funded warrants to purchase 4,237,000 shares of our common stock and common warrants to purchase up to 6,538,500 shares of our common stock at a combined public offering price of $1.30. The pre-funded warrants had an exercise price of $0.001. The common warrants have | |
| other estimated offering expenses. We |
| ● | We are currently evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that we can consummate such a transaction, or consummate a transaction at favorable pricing. |
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Reverse Stock Split
On February 9, 2023, we completed a reverse stock split of our issued and outstanding shares of common stock at a ratio of one-for-fifteen, whereby, every fifteen shares of our issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock without any change in the par value per share. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that would otherwise have resulted from the reverse stock split were rounded up to the next whole number. Our common stock began trading on The NASDAQ Capital Market on a reverse split basis at the market opening on February 10, 2023. All share and per share data have been restated to reflect this reverse stock split.
Expenditures
Under our budget and based upon our existing product development agreements and license agreements pursuant to letters of intent and option agreements, we expect our total research and development expenditures for the next 12 monthsyear ending December 31, 2024 to be approximately $10.7$5.5 million before any contract or grant reimbursements, of which $6.9 millionapproximately all relates to the Specialized BioTherapeutics business and $3.8 million relates to the Vaccines/BioDefense business.segment. We anticipate contractgrant reimbursements infor the next 12 monthssame period of approximately $5.2$0.3 million to offset research and development expenses in the Vaccines/BioDefenseSpecialized BioTherapeutics business segment.
The table below details our costs for research and development by program and amounts reimbursed for the years ended December 31, 20172023 and 2016:2022:
| 2017 | 2016 | |||||||
| Research & Development Expenses | ||||||||
| Oral BDP | $ | - | $ | 184,192 | ||||
| RiVax®& ThermoVax® Vaccines | 607,717 | 447,993 | ||||||
| Dusquetide (SGX942) | 2,774,797 | 1,325,796 | ||||||
| SGX943 | 138 | 1,643 | ||||||
| SGX301 | 1,661,330 | 1,836,974 | ||||||
| Other | 463,051 | 499,269 | ||||||
| Total | $ | 5,507,033 | $ | 4,295,867 | ||||
| Reimbursed under Government Contracts and Grants | ||||||||
| OrbeShield® | $ | 129,376 | $ | 3,797,178 | ||||
| RiVax®& ThermoVax® Vaccines | 3,735,998 | 4,636,493 | ||||||
| SGX942 | 238,358 | - | ||||||
| SGX301 | 206,351 | - | ||||||
| Total | $ | 4,310,083 | $ | 8,433,671 | ||||
| Grand Total | $ | 9,817,116 | $ | 12,729,538 | ||||
| | | | | | |
|
| 2023 |
| 2022 | ||
Research & Development Expenses |
| |
|
| |
|
RiVax® and ThermoVax® Vaccines | | $ | 133,186 | | $ | 346,894 |
SGX942 (Dusquetide) | |
| (28,570) | |
| 295,376 |
CiVax™ | |
| — | |
| 22,901 |
HyBryte™ (SGX301 or synthetic hypericin) | |
| 2,698,609 | |
| 6,831,827 |
Other | |
| 509,474 | |
| 447,091 |
Total | | $ | 3,312,699 | | $ | 7,944,089 |
| | | | | | |
Reimbursed under Government Contracts and Grants | |
|
| |
|
|
RiVax® and ThermoVax® Vaccines | | $ | — | | $ | 22,161 |
CiVax™ | | | 311,495 | | | 398,001 |
SGX943 | |
| 35,429 | |
| 98,731 |
HyBryte™ (investigator-initiated study) | | | 395,124 | | | 31,929 |
Total | | | 742,048 | | | 550,822 |
Grand Total | | $ | 4,054,747 | | $ | 8,494,911 |
Contractual Obligations
We have licensing fee commitments of approximately $500,000 at$230,000 as of December 31, 20172023 over the next five years for several licensing agreements with consultantspartners and universities. Additionally, we have collaboration and license agreements, which upon clinical or commercialization success may require the payment of milestones of up to $7.9approximately $13.2 million, and/or royalties up to 6% ofon net sales of covered products ranging from 2% to 3%, sub-license IND milestones on covered products of up to approximately $200,000, sub-license income royalties on covered products up to 15% and sub-license global net sales royalties on covered products ranging from 1.5% to 2.5%, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur. As of December 31, 2017, we have accrued for approximately $197,000 in milestone payments.
We currently lease approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey pursuant to a lease that was amended in October 2017 and expires in October 2020.Jersey. This office space currently serves as our corporate headquarters.headquarters, and both of our business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. Pursuant to an amendment on June 21, 2022, the lease has been extended to October 2025. The current rent for the first 12 months is approximatelyof $11,367 per month or approximately $22.00 per square foot. The rent will increasebe maintained until November 2024 when it will be increased to approximately $11,625 per month, or approximately $22.50 per square foot, for the next 12 months and increase to approximately $11,883 per month, or approximately $23.00 per square foot for the remainder of the lease.where it will remain until expiration. Our office space is sufficient to satisfyfor our current needs.
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In September 3, 2014, we entered into an asset purchase agreement with Hy Biopharma Inc. (“Hy Biopharma”) pursuant to which we acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, we initially paid $275,000 in cash and issued 184,91212,328 shares of common stock with a fair value based upon our stock price on the date of grant of $3,750,000.$3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in our research and development activities and do not have alternative future use pursuant to generally accepted accounting principles in the United States. Provided all future success-oriented milestones are attained, we will be required to make payments of up to $10.0 million, if and when achieved. Payments will be payable in restricted securities of the Company not to exceed 19.9% ownership of our outstanding stock. As of December 31, 2017, no milestone payments have been made or accrued.
U.S.
In February 2007,January 2020, our Board of Directors authorized an amendment to Dr. Schaber’s employment agreement to increase the issuancenumber of 5,000 shares of our common stock from 334 to 33,334, issuable to Dr. Schaber immediately prior to the completion of a transaction, or series or a combination of related transactions, negotiated by our Board of Directors whereby, directly or indirectly, a majority of our capital stock or a majority of our assets are transferred from us and/or our stockholders to a third party. Dr. Schaber’s amended employment agreement includes
In March 2020, we filed a prospectus supplement covering the offer and sale of up to 130,413 shares of our obligationcommon stock, which were issued to Hy Biopharma. We were required to issue suchthe shares to Hy Biopharma as payment following the achievement of a milestone under the asset purchase agreement, specifically, the Phase 3 clinical trial of HyBryte™ being successful in the treatment of CTCL. The number of shares of our common stock issued to Hy Biopharma was calculated using an effective price of $38.40 per share, based upon a formula set forth in the asset purchase agreement.
Provided the final success-oriented milestone is attained, we will be required to make a payment of up to $5 million, if such event occurs.and when achieved. The potential future payment will be payable in our common stock, not to exceed 19.9% of our outstanding stock.
AsIn December 2020, we entered into a result$20 million convertible debt financing agreement with Pontifax, the healthcare-dedicated venture and debt fund of the above agreements,Pontifax life science funds. Under the terms of the agreement with Pontifax, we had access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and had an interest only period through December 2022 with a rate of 8.47% on borrowed amounts and a 1% rate on amounts available but not borrowed as an unused line of credit fee. After the interest-only period, the outstanding principal was to be repaid in quarterly payments of $1 million each commencing in the first quarter of 2023. The agreement is secured by a lien covering substantially all of our assets, other than intellectual property.
Upon the closing of this transaction, we borrowed the first tranche of $10 million. We did not utilize our option to draw the second or third tranche of $5 million each, which expired on December 15, 2021 and March 15, 2022, respectively.
On April 19, 2023, we entered into an amendment to the convertible debt financing agreement with Pontifax. The amendment required the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The amendment also provided for a new interest only period from the date of the amendment through June 30, 2024, reduced quarterly principal repayments from $1 million to $750,000 and eliminated the minimum cash covenant. Further, the Amendment reduced the conversion price with respect to the remaining principal amount under the agreement to (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 588,599 shares of our common stock issuable upon conversion and to (ii) $1.70 with respect to all shares of our common stock issuable upon conversion in excess of the first 588,599 shares so issued. The remaining terms of the agreement remain in effect without modification.
The amendment to the convertible debt financing agreement with Pontifax resulted in the extinguishment of the original convertible debt for accounting purposes. We elected to account for the amended convertible debt using the fair value option, which requires us to record changes in fair value as a component of other income or expense. The fair value of the convertible debt on the date of the amendment was approximately $3,304,000, which resulted in the recognition of a loss on extinguishment of approximately $394,000 on our accompanying consolidated statements of operations during the year ended December 31, 2023. The fair value of the convertible debt as of December 31, 2023 was approximately $3,260,934, which resulted in the recognition of $43,066 of other income from the change in the fair value of the convertible debt on our accompanying consolidated statements of operations during the year ended December 31, 2023. The fair value of the convertible debt was estimated using the Monte Carlo valuation method.
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Pontifax may elect to convert the outstanding loan drawn under the first tranche into shares of our common stock at any time prior to repayment. We also have the ability to force the conversion of the loan into shares of our common stock, subject to certain conditions.
Contingencies
We follow subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to us but which will only be resolved when one or more future contractual obligations overevents occur or fail to occur. We assess such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable and reasonably estimable.
CARES Act Employee Retention Credit
The Coronavirus Aid, Relief, and Economic Security Act provides for an employee retention credit (“CARES ERC”), which is a refundable tax credit equal to 70% of qualified wages paid to employees during a quarter, capped at $10,000 of qualified wages per employee.
We qualified for the next five yearsCARES ERC for qualified wages through September 30, 2021. We have submitted filings for refunds of the CARES ERC but cannot reasonably estimate when or if we will receive any or all of the requested refunds. We have elected to follow subtopic 450-30 of the FASB Accounting Standards Codification and to account for the CARES ERC only when all uncertainties regarding realization have been resolved. During October 2023, we received a refund of $120,771. The refund was recorded as follows:other income on our accompanying consolidated statements of operations.
COVID-19
Year | Research and Development | Property and Other Leases | Total | |||||||||
| 2018 | $ | 100,000 | $ | 139,765 | $ | 239,765 | ||||||
| 2019 | 100,000 | 148,561 | 248,561 | |||||||||
| 2020 | 100,000 | 127,377 | 227,377 | |||||||||
| 2021 | 100,000 | 5,696 | 105,696 | |||||||||
| 2022 | 100,000 | - | 100,000 | |||||||||
| Total | $ | 500,000 | $ | 421,399 | $ | 921,399 | ||||||
Based on the current outbreak of SARS-CoV-2, the pathogen responsible for COVID-19, which has already had an impact on financial markets, there could be additional repercussions to our operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites.
COVID-19 affected our operations but did not have a material impact on our business, operating results, financial condition or cash flows as of and for the year ended December 31, 2023.
The future impact of the outbreak is highly uncertain and cannot be predicted, and we cannot provide any assurance that the outbreak will not have a material adverse impact on our operations or future results or filings with regulatory health authorities. The extent of the impact to us, if any, will depend on future developments, including actions taken to contain the coronavirus.
Item 8. Financial Statements and Supplementary Data
The information required by this Item 8 is contained on pages F-1 through F-24F-22 of this Annual Report on Form 10-K and is incorporated herein by reference.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
On September 15, 2023, we filed a Form 8-K announcing a change in our independent registered public accounting firm. Subsequent to the filing of our Annual Report on Form 10-K for the year ended December 31, 2022 and the Proxy Statement for our 2023 Annual Meeting of Stockholders, the Audit Committee of our Board of Directors conducted a competitive process to determine our independent registered public accounting firm for the fiscal year ending December 31, 2023. The Audit Committee solicited information from several independent registered public accounting firms, including EisnerAmper LLP (“EisnerAmper”), our former independent registered public accounting firm, in this process.
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Following receipt and review of proposals from the independent registered public accounting firms that participated in the process, the Audit Committee of our Board of Directors recommended and authorized the dismissal of EisnerAmper as our independent registered public accounting firm, and authorized the engagement of Cherry Bekaert LLP (“Cherry Bekaert”) to serve as our independent registered public accounting firm for the fiscal year ending December 31, 2023. The termination of EisnerAmper as our independent registered public accounting firm became effective immediately, with Cherry Bekaert commencing work with respect to our unaudited interim financial statements as of and for the quarter ended September 30, 2023, and the filing of the related Quarterly Report on Form 10-Q.
No audit report of EisnerAmper on our financial statements for either of the past two fiscal years contained an adverse opinion or a disclaimer of opinion, or was qualified or modified as to uncertainty, audit scope, or accounting principles. The report of EisnerAmper on our financial statements for the fiscal year ended December 31, 2022 was prepared assuming that we would continue as a going concern and included an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern as result of recurring losses from operations and an expectation that losses would be incurred for the foreseeable future.
During our two most recent fiscal years and subsequent interim period preceding EisnerAmper’s dismissal, there was no “disagreement” (as described in Item 304(a)(1)(iv) of Regulation S-K and the related instructions) with EisnerAmper on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedures which, if not resolved to the satisfaction of EisnerAmper, would have caused EisnerAmper to make reference to the matter in their report.
During our two most recent fiscal years and subsequent interim period preceding EisnerAmper’s dismissal, there were no “reportable events” requiring disclosure pursuant to Item 304(a)(1)(v) of Regulation S-K. Our principal executive officer and principal financial officer concluded that, as of June 30, 2023, our disclosure controls and procedures were not effective because of material weaknesses in our internal control over financial reporting. Specifically, our management concluded that our processes and procedures around the accounting for complex financial instruments issued by us resulted in a delay in finalizing the financial statements. Inasmuch as such delay caused us to utilize the five-day extension of the original due date of the Quarterly Report on Form 10-Q provided by Rule 12b-25 of the Exchange Act, our management concluded that our disclosure controls and procedures were not effectively designed to ensure that information required to be disclosed by us in reports we file or submit under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
We provided EisnerAmper with a copy of the September 15, 2023 Form 8-K prior to its filing with the SEC and requested EisnerAmper to furnish us with a letter addressed to the SEC stating whether EisnerAmper agreed with the statements made by us in response to Item 304(a) of Regulation S-K and, if not, stating the respects in which it did not agree.
None.In conjunction with the request for proposal and review of information from other independent registered public accounting firms noted above, on September 15, 2023, we engaged Cherry Bekaert to serve as our independent registered public accounting firm to audit our financial statements for the fiscal year ending December 31, 2023, and to perform a review of our interim financial statements for the third fiscal quarter of 2023.
During our two most recent fiscal years and subsequent interim period preceding Cherry Bekaert’s engagement, neither we nor anyone on our behalf consulted Cherry Bekaert regarding (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on our financial statements, and no written report or oral advice was provided by Cherry Bekaert to us that Cherry Bekaert concluded was an important factor considered by us in reaching a decision as to the accounting, auditing or financial reporting issue, or (ii) any matter that was either the subject of a “disagreement” (as described in Item 304(a)(1)(iv) of Regulation S-K and the related instructions) or a “reportable event” (as described in Item 304(a)(1)(v) of Regulation S-K).
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are the Company’sour controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file under the Exchange Act is accumulated and
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communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the possible controls and procedures.
Our management has evaluated, with the participation of our principal executive officer and principal financial officer, the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report. Based upon that evaluation, our management, including our principal executive officer and principal financial officer, has concluded that, as of the end of the period covered by this report, the Company’sour disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Annual Report on Internal Controlover Financial Reporting
Company management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by the Company’sour Board of Directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
| ● | pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of |
| ● | provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures |
| ● | provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of |
Because of inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management assessed the effectiveness of the Company’sour internal control over financial reporting as of December 31, 2017.2023. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) inInternal Control-Integrated Framework, 2013.
Based on our assessment, management has concluded that, as of December 31, 2017, the Company’s2023, our internal control over financial reporting is effective.
Changes in Internal Control over Financial Reporting
There were no changes in the Company’sour internal control over financial reporting identified in connection with the evaluation of such internal control that occurred during the Company’sour last fiscal quarter that have materially affected, or are reasonably likely to materially affect, the Company’sour internal control over financial reporting.
Item 9C Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
Not applicable.
None.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance
The table below contains information regarding the current members of the Board of Directors and executive officers. The ages of individuals are provided as of March 9, 2018:15, 2024.
Name | Age | Position | ||
Christopher J. Schaber, PhD | | 57 | | Chairman of the Board, Chief Executive Officer and President |
Gregg A. Lapointe, CPA, MBA | | 65 | | Director |
Diane L Parks, MBA | | 71 | | Director |
Robert J. Rubin, MD | | 78 | | Director |
Jerome B. Zeldis, MD, PhD | | 73 | | Director |
Jonathan Guarino, CPA, CGMA | | 51 | | |
Chief Financial Officer, Senior Vice President and Corporate Secretary | ||||
Oreola Donini, PhD | | 52 | | Chief Scientific Officer and Senior Vice President |
Richard Straube, MD | | 72 | | Chief Medical Officer and Senior Vice President |
Christopher J. Schaber, PhD has over 2830 years of experience in the pharmaceutical and biotechnology industry. Dr. Schaberhas been our President and Chief Executive Officer and a director since August 2006. He was appointed Chairman of the Board onin October 8, 2009. He also has served on the board of directors of the Biotechnology Council of New Jersey (“BioNJ”) since January 2009 and the Alliance for Biosecurity since October 2014, and has been a member of the corporate councilscouncil of both the National Organization for Rare DiseasesDisorders (“NORD”) and the American Society for Blood and Marrow Transplantation (“ASBMT”) since October 2009 and July 2009, respectively.2009. He also serves on the scientific advisory board for private start-up medical device company, Simphotek, Inc. Prior to joining Soligenix, Dr. Schaber served from 1998 to 2006 as Executive Vice President and Chief Operating Officer of Discovery Laboratories, Inc., where he was responsible for overall pipeline development and key areas of commercial operations, including regulatory affairs, quality control and assurance, manufacturing and distribution, pre-clinical and clinical research, and medical affairs, as well as coordination of commercial launch preparation activities. From 1996 to 1998, Dr. Schaber was a co-founder of Acute Therapeutics, Inc., and served as its Vice President of Regulatory Compliance and Drug Development. From 1994 to 1996, Dr. Schaber was employed by Ohmeda PPD, Inc., as Worldwide Director of Regulatory Affairs and Operations. From 1989 to 1994, Dr. Schaber held a variety of regulatory, development and operations positions with The Liposome Company, Inc., and Elkins-Sinn Inc., a division of Wyeth-Ayerst Laboratories. Dr. Schaber received his BA degree from Western Maryland College, his MS degree in Pharmaceutics from Temple University School of Pharmacy and his PhD degree in Pharmaceutical Sciences from the Union Graduate School. During his career, Dr. Schaber has played a significant role in raising in excess of $350 million through both public offerings and private placements, as well as approximately $100 million in non-dilutive funding awards from state and federal governmental agencies. Dr. Schaber was selected to serve as a member of our Board of Directors because of his extensive experience in drug development and pharmaceutical operations, including his experience as ana senior executive senior officer with our Company and Discovery Laboratories, Inc., and as a member of the board of directors of BioNJ;BioNJ and Simphotek; because of his proven ability to raise funds and provide access to capital; and because of his advanced degrees in science and business.
Keith L. Brownlie, CPA has been a director since June 2011. In June 2017, Mr. Brownlie began serving on the Board of Directors of Celldex Therapeutics, Inc., a publicly traded biotechnology company that is developing targeted therapeutics to address devastating diseases. He also serves on the Board of Directors of Rxi Pharmaceuticals Corporation, a publicly traded biotechnology company involved in the research and development of RNAi products for the diagnosis, prevention and treatment of human diseases, a position he has held since June 2012. From July 2013 until December 2014, Mr. Brownlie served on the Board of Directors of Cancer Genetics, Inc., a publicly traded, early stage diagnostics company. Mr. Brownlie served as a member of the Board of Directors of Epicept Corporation, a publicly traded, specialty pharmaceutical company focused on the clinical development and commercialization of pharmaceutical products for the treatment of cancer and pain, from April 2011 to August 2013 when Epicept Corporation merged with Immune Pharmaceuticals, Inc. From 1974 to 2010, Mr. Brownlie worked with the accounting firm of Ernst & Young LLP where he served as audit partner for numerous public companies and was the Life Sciences Industry Leader for the New York metro area. Mr. Brownlie received a BS in Accounting from Lehigh University and is a Certified Public Accountant in the state of New Jersey. Mr. Brownlie co-founded the New Jersey Entrepreneur of the Year Program and was Vice President and Trustee of the New Jersey Society of CPAs. In addition, he served as accounting advisor to the Board of the Biotechnology Council of New Jersey. Mr. Brownlie was selected to serve as a member of our Board of Directors because of his vast experience as an audit partner for numerous public companies and as a director of publicly traded specialty pharmaceutical and biotechnology companies.
Marco M. Brughera, DVM joined the Board of Directors in October 2013. He is the Global Head Rare Disease of the Leadiant Group, a position he has held since October 2012. Dr. Brughera serves as CEO on the Board of Directors of Leadiant Biosciences SpA and as director on the Board of Directors of Leadiant Biosciences Ltd, Leadiant Biosciences, Inc., and Fennec Pharmaceuticals, Inc. From December 2011 through January 2014, Dr. Brughera served on the Board of Directors of Gentium S.p.A., a publicly traded biopharmaceutical company. From January 2011 through October 2012, Dr. Brughera held several other positions with the Sigma-Tau Group, including Corporate Research and Development Managing Director of Sigma-Tau I ndustrie Farmaceutiche Riuntite S.p.A., President of Sigma-Tau Research Switzerland S.A. and board member of Sigma-Tau Pharmaceuticals, Inc. (now known as Leadiant Biosciences, Inc.), and of Sigma-Tau Rare Diseases S.A. and Sigma-Tau Pharma Ltd. From 2004 to 2010, Dr. Brughera served as the Vice President of Preclinical Development at Nerviano Medical Sciences S.r.l. (“NMS Group”), a pharmaceutical oncology-focused integrated discovery and development company. He also served as the Managing Director at Accelera, S.r.l., an independent contract research organization affiliated with the NMS Group. From 1999 to 2004, Dr. Brughera held several senior level positions in the areas of discovery and development toxicology with Pharmacia Corporation and Pfizer, Inc. Prior to 1999, he held various positions at Pharmacia& Upjohn Company, Inc., and Farmitalia Carlo Erba S.p.A., an Italian pharmaceutical company. Dr. Brughera earned his degree in veterinary medicine from the University of Milan and is a European Registered Toxicologist. Dr. Brughera was selected to serve as a member our Board of Directors because of his background in the areas of drug discovery and development and his experience as an executive officer and a director in the pharmaceutical industry.
Gregg A. Lapointe, CPA, MBAhas been a director since March 2009. Mr. Lapointe is currently CEO of Cerium Pharmaceuticals, Inc. and serves on the Boardboard of Directorsdirectors of Rigel Pharmaceuticals, Inc., and CytoriAstria Therapeutics, Inc. He also currently serves on the Board of Trustees of the Keck Graduate Institute of Applied Life Sciences. Mr. Lapointe has previously served on the Boardboard of Directorsdirectors of ImmunoCellular Therapeutics Ltd., Raptor Pharmaceuticals, Inc., SciClone Pharmaceuticals, Inc., the Pharmaceuticals Research and Manufacturers of America (PhRMA) and, Questcor Pharmaceuticals, Inc. and the board of trustees of the Keck Graduate Institute of Applied Life Sciences. He previously served in varying roles for Sigma-Tau Pharmaceuticals, Inc. (now known as Leadiant Biosciences, Inc.), a private biopharmaceutical company, from September 2001 through February 2012, including Chief Operating Officer from November 2003 to April 2008 and Chief Executive Officer from April 2008 to February 2012. From May, 1996 to August 2001, he served as Vice President of Operations and Vice President, Controller of AstenJohnson, Inc. (formerly JWI Inc.). Prior to that, Mr. Lapointe spent several years in the Canadian medical products industry in both distribution and manufacturing. Mr. Lapointe began his career at Price Waterhouse. Mr. Lapointe received his B.A. degree in Commerce from Concordia University in Montreal, Canada, a graduate diploma in Accountancy from McGill University and his M.B.A. degree from Duke University. He is a C.P.A. in the state of Illinois. Mr. Lapointe was selected to serve as a member of our Board of Directors because of his significant experience in the areas of global strategic planning and implementation, business development, corporate finance, and acquisitions, and his experience as an executive officer and board member in the pharmaceutical and medical products industries.
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Diane L. Parks, MBA has been a director since July 2019. From February 2016 until July 2018, she served as Head of U.S. Commercial and Senior Vice President of Marketing, Sales & Market Research at Kite Pharma, Inc., a privately-held biopharma company developing cancer immunotherapy products with a primary focus on genetically engineered autologous T cell therapy with chimeric antigen receptors. From October 2014 to October 2015, Ms. Parks served as Vice President of Global Marketing at Pharmacyclics LLC, a privately-held biopharmaceutical company primarily focused on the development of cancer therapies. Prior to Pharmacyclics LLC, Ms. Parks held senior leadership roles as Vice President of Sales for Amgen, Inc., a publicly-traded biopharmaceutical company, representing oncology and nephrology products, and Senior Vice President of Specialty Biotherapeutics and Managed Care at Genentech, Inc., a biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions that was acquired by Roche Holding AG in 2009. At Genentech, she led the launches of multiple products as well as commercial development of Lucentis® and Rituxan®. Since May 2019, she has been a member of the board of directors of Calliditas Therapeutics AB, a biopharmaceutical company, the shares of which are traded on the Nasdaq Stockholm Exchange, that is developing and commercializing pharmaceutical products for patients with significant unmet medical needs in niche indications. She is also a member of the board of directors of Kura Oncology, a biopharmaceutical company, the shares of which are traded on US Nasdaq, that is developing a pipeline of precision medicines for the treatment of solid tumors and blood cancers. Since October 2019 Ms. Parks has been a member of the board of directors for TriSalus Life Sciences, an early stage company focused on improving patient outcomes in pancreatic and other highly intractable solid tumors. Ms. Parks holds a BS from Kansas State University and a master’s of business administration in marketing from Georgia State University. She has been a commercial leader in the biotech and pharma industry for over 30 years. Ms. Parks was selected to serve as a member of our Board of Directors because of her over 30 years’ experience as a businesswoman and commercial executive with an extensive record of driving profitable growth for large pharmaceutical and biotech companies.
Robert J. Rubin, MDhas been a director since October 2009. Dr. Rubin was a clinical professor of medicine at Georgetown University from 1995 until 2012 when he was appointed a Distinguished Professor of Medicine. From 1987 to 2001, he was presidentPresident of the Lewin Group (purchased by Quintiles Transnational Corp. in 1996), an international health policy and management consulting firm. From 1994 to 1996, Dr. Rubin served as Medical Director of ValueRx, a pharmaceutical benefits company. From 1992 to 1996, Dr. Rubin served as President of Lewin-VHI, a health care consulting company. From 1987 to 1992, he served as President of Lewin-ICF, a health care consulting company. From 1984 to 1987, Dr. Rubin served as a principal of ICF, Inc., a health care consulting company. From 1981 to 1984, Dr. Rubin served as the Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services and as an Assistant Surgeon General in the United StatesU.S. Public Health Service. Dr. Rubin has served on the Board of BioTelemetry, Inc. (formerly known as CardioNet, Inc.) from 2007 to February 2021. He is currently on the Board of Cerium Pharmaceuticals where he is also the acting Chief Medical Officer since 2007.July 2022. He is a board certified nephrologist and internist. Dr. Rubin received an undergraduate degree in Political Science from Williams College and his medical degree from Cornell University Medical College. Dr. Rubin was selected to serve as a member of our Board of Directors because of his vast experience in the health care industry, including his experience as a nephrologist, internist, clinical professor of medicine and Assistant Surgeon General, and his business experience in the pharmaceutical industry.
Jerome B. Zeldis, MD, PhDhas been a director since June 2011. In March 2023 Dr. Zeldis is currentlyretired as Executive Vice President, Research and Development of Neximmune. He was the Chief Medical Officer and President of Clinical Research, Drug Safety and Regulatory of Sorrento Therapeutics, Inc. He is also Chief Medical Officer and Principal at Celularity, Inc. Previously, Dr. Zeldis was Chief Executive Officer of Celgene Global Health and Chief Medical Officer of Celgene Corporation, a publicly traded, fully integrated biopharmaceutical company. He was employed by CelegeneCelgene from 1997 to 2016. From September 1994 to February 1997, Dr. Zeldis worked at Sandoz Research Institute and the Janssen Research Institute in both clinical research and medical development. He has been a board member of several biotechnology companies and is currently on the boards of Metastat, Inc., PTC Therapeutics Inc., BioSig Technologies, Inc., the Castleman’sCastleman's Disease Organization and Alliqua, Inc. He has previously served on the boards of the NJ Chapter of the Arthritis Foundation and PTC Therapeutics, Inc. Additionally, he has served as Assistant Professor of Medicine at the Harvard Medical School (fromfrom July 1987 to September 1988),1988, Associate Professor of Medicine at University of California, Davis from (SeptemberSeptember 1988 to September 1994),1994, Clinical Associate Professor of Medicine at Cornell Medical School (Januaryfrom January 1995 to December 2003)2003 and Professor of Clinical Medicine at the Robert Wood Johnson Medical School (Julyfrom July 1998 to June 2010).2010. Dr. Zeldis received a BA and an MS from Brown University, and an MD, and a PhD in Molecular Biophysics and Biochemistry from Yale University. Dr. Zeldis trained in Internal Medicine at the UCLA Center for the Health Sciences and in Gastroenterology at the Massachusetts General Hospital and Harvard Medical School. Dr. Zeldis was selected to serve as a member of our Board of Directors because of his experience as an executive officer of a publicly traded biopharmaceutical company and in clinical research and medical
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development, and his experience in the health care industry, including his experience as an internist, gastroenterologist and professor of medicine.
Jonathan Guarino, CPA, CGMA has been with our company since September 2019 and is currently our Senior Vice President and Chief Financial Officer. Mr. Guarino has had significant experience with both development-stage and commercial companies. From September 2016 to July 2019, he served as Corporate Controller for Hepion Pharmaceuticals, Inc. (formerly ContraVir Pharmaceuticals, Inc.), a New Jersey-based public biotechnology company, where he contributed to the establishment of the financial infrastructure, as well as assisted with capital fund-raising and debt financings. He worked as Controller for Suite K Value Added Services LLC from August 2015 to September 2016 and as a senior manager of technical accounting for Covance, Inc., from June 2014 to May 2015. Prior to these positions, he held accounting and finance positions of increasing importance with several companies, including PricewaterhouseCoopers LLP, BlackRock, Inc. and Barnes & Noble, Inc. Mr. Guarino is a CPA (certified public accountant) and CGMA (chartered global management accountant), who received his BS in Business from Montclair State University.
Oreola Donini, PhD, has been with our company since August 15, 2013 and is currently our Chief Scientific Officer and Senior Vice President, a position she has held since December 5, 2014. Dr. Donini served as our Vice President of Preclinical Research and Development from August 15, 2013 until December 4, 2014. She has more than 1520 years’ experience in drug discovery and preclinical development with start-up biotechnology companies. From 2012 to 2013, Dr. Donini worked with ESSA Pharma Inc. as Vice President Research and Development. From 2004 to 2013, Dr. Donini worked with Inimex Pharmaceuticals Inc., (“Inimex”), lastly as Senior Director of Preclinical R&D from 2007-2013.2007 to 2013. Prior to joining Inimex, she worked with Kinetek Pharmaceuticals Inc., developing therapies for infectious disease, cancer and cancer supportive care. Dr. Donini is a co-inventor and leader of the Company’sour SGX94 innate defense regulator technology, developed by Inimex and subsequently acquired by the Company.us. She was responsible for overseeing the manufacturing and preclinical testing of SGX94, which demonstrated efficacy in combating bacterial infections and mitigating the effects of tissue damage due to trauma, infection, radiation and/or chemotherapy treatment. These preclinical studies resulted in a successful Phase 1 clinical study and clearance of Phase 2 protocols for oral mucositis in head and neck cancer and acute bacterial skin and skin structure infections. While with ESSA Pharma Inc. as the Vice President of Research and Development, Dr. Donini led the preclinical testing of a novel N-terminal domain inhibitor of the androgen receptor for the treatment of prostate cancer. While with Kinetek Pharmaceuticals Inc., her work related to the discovery of novel kinase and phosphatase inhibitors for the treatment of cancer. Dr. Donini received her PhD from Queen’s University in Kinston, Ontario, Canada and completed her post-doctoral work at the University of California, San Francisco. Her research has spanned drug discovery, preclinical development, manufacturing and clinical development in infectious disease, cancer and cancer supportive care.
Karen Krumeich has been with our company since June 2016 and is currently our Senior Vice President and Chief Financial Officer. Ms. Krumeich has served as Chief Financial Officer and Vice President of Finance for public and private emerging-growth, start-up and national companies in various sectors of healthcare, including pharmaceuticals, medical devices and healthcare service companies. She has expertise in equity financings, both private and public, Sarbanes-Oxley compliance, acquisitions and integrations, strategic business development and operations analysis. Most recently Ms. Krumeich was the Vice President of Finance for Cerecor Inc., a clinical stage neuroscience company. At Cerecor she was involved in the company’s equity financings and was responsible for all finance and administrative functions. Prior to joining Cerecor she was a CFO Partner with Tatum, LLC, a national consulting firm, and a member of the firm’s National Healthcare Group. As a Partner with Tatum, she served as Interim Chief Financial Officer for drug development and medical device companies. Prior to joining Tatum in 2006, she was the Vice President of Finance and Chief Financial Officer of Strata Skin Sciences, Inc. (formerly Mela Sciences, Inc.), a publicly traded development-stage medical device company. At Mela Sciences, she played a key role in the company’s initial public offering and was responsible for all functional areas of finance and accounting, administration, and investor relations. As Vice President of Finance of Gran Care Pharmacy, Inc., she was responsible for the financial leadership of the pharmacy division and directed an aggressive acquisition program. Ms. Krumeich began her career with a B.S. in Pharmacy from the University of Toledo, subsequently completed an accounting major and transitioned into finance after completing the CPA exam.
Richard Straube, MDhas been with our company since January 2014 and is currently our Senior Vice President and Chief Medical Officer. Dr. Straube is a board-certified pediatrician with over 35 years’ experience in both academia and industry, including clinical research experience in host-response modulation. From 2009 until joining our company, he was Chief Medical Officer of Stealth Peptides Incorporated, a privately-held, clinical stage, biopharmaceutical company. Prior to joining the Company,us, Dr. Straube served from 1988 to 1993 in various capacities, including most recently as Senior Director, Infectious Diseases and Immunology, Clinical Research, for Centocor, Inc., a privately-held biopharmaceutical company focused on developing monoclonal antibody-based diagnostics. While at Centocor, Inc., Dr. Straube was responsible for the initial anti-cytokine and anti-endotoxin programs targeted at ameliorating inappropriate host responses to infectious and immunologic challenges. Programs that he managed at Centocor, Inc. include assessments of immunomodulation using monoclonal removal of inciting molecular triggers, removal of internal immune-messengers, augmentation of normal host defenses, and maintenance of normal sub-cellular function in the face of injury. From 1993 to 1995, Dr. Straube was Director of Medical Affairs at T-cell Sciences, Inc., a privately-held biotechnology company. From 1995 to 1997, he was Director of Clinical Investigations of the Pharmaceutical Products Division of Ohmeda Corp., a privately-held biopharmaceutical company. He served from 1998 to 2007 as Executive Vice President of Research and Development and Chief Scientific Officer at INO Therapeutics LLC, a privately-held biotherapeutics company, where he was responsible for the clinical trials and subsequent approval of inhaled nitric oxide for the treatment of persistent pulmonary hypertension of the newborn. From 2007 to 2009, Dr. Straube was the Chief Medical Officer at Critical Biologics Corporation, a privately-held biotechnology company. Dr. Straube received his medical degree and residency training at the University of Chicago, completed a joint adult and pediatrician infectious diseases fellowship at the University of California, San Diego (“UCSD”), and as a Milbank Scholar completed training in clinical trial design at the London School of Hygiene and Tropical Medicine. While on the faculty at the UCSD Medical Center, his research focused on interventional studies for serious viral infections.
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Board Leadership Structure
Our Board of Directors believes that Dr. Schaber’s service as both the Chairman of our Board of Directors and our Chief Executive Officer is in the best interest of our Company and our stockholders. Dr. Schaber possesses detailed and in-depth knowledge of the issues, opportunities and challenges facing our Company and our business and, therefore, is best positioned to develop agendas that ensure that the Board of Directors’ time and attention are focused on the most important matters. His combined role enables decisive leadership, ensures clear accountability, and enhances our ability to communicate our message and strategy clearly and consistently to our stockholders, employees, and collaborative partners.
Messrs. Brownlie andMr. Lapointe, Dr. Brughera,Ms. Parks, Dr. Rubin, and Dr. Zeldis are independent and the Board of Directors believes that the independent directors provide effective oversight of management. Moreover, in addition to feedback provided during the course of meetings of the Board of Directors, the independent directors hold executive sessions. Following an executive session of independent directors, the independent directors’ report back to the full Board of Directors regarding any specific feedback or issues, provide the Chairman with input regarding agenda items for Board of Directors and Committee meetings, and coordinate with the Chairman regarding information to be provided to the independent directors in performing their duties. The Board of Directors believes that this approach appropriately and effectively complements the combined Chairman/Chief Executive Officer structure.
Although the Company believeswe believe that the combination of the Chairman and Chief Executive Officer roles is appropriate under the current circumstances, our corporate governance guidelines do not establish this approach as a policy, and the Board of Directors may determine that it is more appropriate to separate the roles in the future.
Role of the Board of Directors in Risk Oversight
Section 16(a) Beneficial Ownership Reporting Compliance
We are required to identify each person who was an officer, director or beneficial ownerOne of more than 10%the key functions of our registered equity securities duringBoard of Directors is informed oversight of our most recent fiscal yearrisk management process. Our Board of Directors does not have a standing risk management committee, but rather administers this oversight function directly through the Board of Directors as a whole, as well as through various standing committees of our Board of Directors that address risks inherent in their respective areas of oversight. The Board of Directors is engaged in the oversight of risk through regular updates from Dr. Schaber, in his role as our Chief Executive Officer, and who failedother members of our management team, regarding those risks confronting us (including risks relating to fileregulatory compliance, information technology and cybersecurity, environmental and sustainability, climate change and public health), the actions and strategies necessary to mitigate those risks and the status and effectiveness of those actions and strategies. The updates are provided at regularly scheduled Board of Directors and committee meetings as well as through more frequent informal meetings that include our Board of Directors, our Chief Executive Officer, our Chief Financial Officer, our Chief Medical Officer and our Chief Scientific Officer and other members of our management team. The Board of Directors provides insight into the issues, based on a timely basis reports requiredthe experience of its members, and provides constructive challenges to management’s assumptions and assertions.
In particular, our Board of Directors is responsible for monitoring and assessing strategic risk exposure and our Audit Committee has the responsibility to consider and discuss our major financial risk exposures and the steps our management has taken to monitor and control these exposures, including guidelines and policies to govern the process by Section 16(a)which risk assessment and management is undertaken. The Audit Committee also monitors compliance with legal and regulatory requirements. Our Nominating and Corporate Governance Committee monitors the effectiveness of our corporate governance practices, including whether they are successful in preventing illegal or improper liability-creating conduct. Our compensation committee assesses and monitors whether any of our compensation policies and programs has the Exchange Act.
To our knowledge, based solely on review of these filings and written representations from the certain reporting persons, we believe that during the year ended December 31, 2017, our officers, directors and significant stockholders have timely filed the appropriate form under Section 16(a) of the Exchange Act.
potential to encourage excessive risk-taking.
Committees of the Board of Directors
Our Board of Directors has the following three committees: (1) Compensation, (2) Audit and (3) Nominating and Corporate Governance. Our Board of Directors has adopted a written charter for each of these committees, which are available on our website at www.soligenix.com under the “Investors” section.
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| | | | | | Nominating and |
| |  Audit | | Compensation | |  Corporate Governance |
Director | Committee | Committee | Committee | |||
Gregg A. Lapointe, CPA | |
| | | |
|
Diane L. Parks, MBA | |
| |
| | |
Robert J. Rubin, MD | |
| |
| |
|
Jerome B. Zeldis, MD, PhD | | | |
| |
|
– Committee Chair
– Member
Audit Committee
Our Board of Directors has an Audit Committee, which is comprised of Mr. BrownlieLapointe (Chair), Mr. LapointeMs. Parks and Dr. Rubin. The Audit Committee assists our Board of Directors in monitoring the financial reporting process, the internal control structure and the independent registered public accountants. Its primary duties are to serve as an independent and objective party to monitor the financial reporting process and internal control system, to review and appraise the audit effort of the independent registered public accountants and to provide an open avenue of communication among the independent registered public accountants, financial and senior management, and our Board of Directors. Our Board of Directors has determined that Mr. Brownlie, Mr. Lapointe, Ms. Parks and Dr. Rubin are “independent” directors, within the meaning of applicable listing standards of The Nasdaq Stock Market LLC (“Nasdaq”) and the Exchange Act and the rules and regulations thereunder. Our Board of Directors has also determined that the members of the Audit Committee are qualified to serve on the committee and have the experience and knowledge to perform the duties required of the committee and that Mr. BrownlieLapointe qualifies as an “audit committee financial expert” as that term is defined in the applicable regulations of the Exchange Act.
Compensation Committee
Our Board of Directors has a Compensation Committee, which is comprised of Dr. Rubin (Chair), Dr. BrugheraMs. Parks and Dr. Zeldis. The Compensation Committee is responsible for reviewing and approving the executive compensation program, assessing executive performance, setting salary, making grants of annual incentive compensation and approving certain employment agreements. Our Board of Directors has determined that Dr. Brughera, Dr. Rubin, Mr. Lapointe and Dr. Zeldis are “independent” directors within the meaning of applicable listing standards of Nasdaq and the Exchange Act and the rules and regulations thereunder.
Nominating and Corporate Governance Committee
Our Board of Directors has a Nominating and Corporate Governance Committee (“Nominating Committee”), which is comprised of Dr. Zeldis (Chair), Mr. BrownlieLapointe and Mr. Lapointe.Dr. Rubin. The Nominating Committee makes recommendations to the Board of Directors regarding the size and composition of our Board of Directors, establishes procedures for the nomination process, identifies and recommends candidates for election to our Board of Directors. Our Board of Directors has determined that Dr. Zeldis, Mr. BrownlieLapointe and Mr. LapointeMs. Parks are “independent” directors, as such term is defined by the applicable Nasdaq listing standards.
Code of Ethics
We have adopted a code of ethics that applies to all of our executive officers and senior financial officers (including our chief executive officer, chief financial officer, chief accounting officer and any person performing similar functions). A copy of our code of ethics is publicly available on our website at www.soligenix.com under the “Investors” section. If we make any substantive amendments to our code of ethics or grant any waiver, including any implicit waiver, from a provision of the code to our chief executive officer, chief financial officer or chief accounting officer, we will disclose the nature of such amendment or waiver in a Current Report on Form 8-K.
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Diversity Considerations in Identifying Director Nominees
We do not have a formal diversity policy or set of guidelines in selecting and appointing directors that comprise our Board of Directors. However, when making recommendations to our Board of Directors regarding the size and composition of our Board of Directors, our Nominating Committee does consider each individual director’s qualifications, skills, business experience and capacity to serve as a director and the diversity of these attributes for the Board of Directors as a whole.
Compensation Committee Interlocks and Insider Participation
No member of our Compensation Committee is or has at any time during the past year been one of our officers or employees. None of our executive officers currently serves or in the past year has served as a member of the Board of Directors or Compensation Committee of any entity that has one or more executive officers serving on our Board of Directors or Compensation Committee.
Clawback Policy
In 2023, we adopted a Clawback Policy in compliance with Nasdaq rules. Under our Clawback Policy, if we are required to prepare an accounting restatement due to material noncompliance with the financial reporting requirements under United States securities laws, we will be entitled to recover (and will seek to recover), from our executive officers, any excess incentive-based compensation received by our executive officers during the three-year period prior to the date on which we are required to prepare the restatement. This policy applies to both equity-based and cash compensation awards. The “excess compensation” is the difference between the actual amount that was paid and the amount that would have been paid if the financial statements were prepared properly in the first instance. To ensure that we can enforce the Clawback Policy, we require each executive officer subject to the policy to execute an acknowledgement stating that the executive has received and reviewed the policy and agrees that he or she is fully bound by the policy.
Item 11. Executive Compensation
In 2018, in furtherance of our compensation philosophy and objectives, the Compensation Committee engaged Setren Smallberg & Associates (“SS&A”), an outside executive compensation consulting firm determined to be independent by the Compensation Committee, to conduct a review of, and recommend changes to, our compensation program for our most highly compensated executive officers. A representative of SS&A attended Compensation Committee meetings at the invitation of the Compensation Committee Chairman and was also in direct contact with the Compensation Committee and company management from time to time. SS&A provided the Compensation Committee with assistance and advice in the review of our salary structure, annual and equity incentive awards and other related executive pay issues. In addition, SS&A provided advice regarding marketplace trends and best practices relating to competitive pay levels.
SS&A did not provide any services to us other than its services as the Compensation Committee’s independent compensation consultant, and SS&A did not receive any fees or compensation from us other than the fee it received as the independent compensation consultant. SS&A did not provide any services to us in 2022 or 2023. The Compensation Committee confirmed that SS&A’s work for the Compensation Committee did not create any conflicts of interest.
Summary Compensation
The following table contains information concerning the compensation paid during each of the two years ended December 31, 20172023 and 2022, respectively to our Chief Executive Officer and each of the three other most highly compensated executive officers during 2017 (collectively, the “Named Executive Officers”).
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Summary Compensation
| Name | Position | Year | Salary | Bonus | Option Awards | All Other Compensation | Total | ||||||||||||||||||
| Christopher J. Schaber1 | CEO & | 2017 | $ | 443,668 | $ | 106,480 | $ | 294,300 | $ | 44,529 | $ | 888,977 | |||||||||||||
| President | 2016 | $ | 434,969 | $ | 121,792 | $ | 41,511 | $ | 598,272 | ||||||||||||||||
| Oreola Donini2 | CSO & | 2017 | $ | 220,000 | $ | 44,933 | $ | 123,750 | $ | 4,627 | $ | 393,310 | |||||||||||||
| Senior VP | 2016 | $ | 202,400 | $ | 35,880 | $ | 4,657 | $ | 242.937 | ||||||||||||||||
| Karen Krumeich3 | CFO & | 2017 | $ | 226,440 | $ | 44,835 | $ | 123,750 | $ | 15,184 | $ | 410,209 | |||||||||||||
| Senior VP | 2016 | $ | 120,250 | $ | 23,976 | $ | 74,000 | $ | 7,849 | $ | 226,075 | ||||||||||||||
| Richard C. Straube4 | CMO & | 2017 | $ | 323,060 | $ | 56,213 | $ | 123,750 | $ | 29,560 | $ | 532,583 | |||||||||||||
| Senior VP | 2016 | $ | 316,725 | $ | 68,413 | $ | 27,919 | $ | 413,057 | ||||||||||||||||
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | Option | | All Other | | | | ||
Name |
| Position |
| Year |
| Salary |
| Bonus |
| Awards |
| Compensation |
| Total | |||||
Christopher J. Schaber (1) |
| CEO & |
| 2023 | | $ | 519,476 | | $ | 72,727 | | $ | 75,482 | | $ | 32,800 | | $ | 700,484 |
|
| President |
| 2022 | | $ | 499,496 | | $ | 107,891 | | $ | 73,059 | | $ | 30,740 | | $ | 711,185 |
| | | | | | | | | | | | | | | | | | | |
Jonathan Guarino (2) |
| CFO & |
| 2023 | | $ | 245,000 | | $ | 31,605 | | $ | 45,289 | | $ | 32,800 | | $ | 354,693 |
|
| Senior VP |
| 2022 | | $ | 231,132 | | $ | 42,436 | | $ | 51,042 | | $ | 30,740 | | $ | 355,350 |
| | | | | | | | | | | | | | | | | | | |
Oreola Donini (3) |
| CSO & |
| 2023 | | $ | 300,000 | | $ | 37,800 | | $ | 45,289 | | $ | 4,505 | | $ | 387,594 |
|
| Senior VP |
| 2022 | | $ | 280,800 | | $ | 51,555 | | $ | 27,259 | | $ | 4,628 | | $ | 364,242 |
| | | | | | | | | | | | | | | | | | | |
Richard C. Straube (4) |
| CMO & |
| 2023 | | $ | 189,461 | | $ | 22,736 | | $ | 37,741 | | $ | — | | $ | 249,938 |
|
| Senior VP |
| 2022 | | $ | 182,174 | | $ | 32,901 | | $ | 27,259 | | $ | — | | $ | 242,334 |
| (1) | Dr. Schaber deferred the payment of his 2023 bonus of $72,727 until January 15, 2024. Option awards figure includes the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation represents health insurance costs paid by us. |
| (2) | Mr. Guarino deferred the payment of his 2023 bonus of $31,605 until January 15, 2024. Option awards figure includes the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation represents health insurance costs paid by us. |
| (3) | Dr. Donini deferred the payment of her 2023 bonus of $37,800 until January 15, 2024. Option awards figure includes the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation represents health insurance costs paid by us. |
| (4) | Dr. Straube deferred the payment of his 2023 bonus of $22,736 until January 15, 2024. Option awards figure includes the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation represents health insurance costs paid by us. |
1Dr. Schaber deferred the payment of 2017 bonus of $106,480 until January 15, 2018. Option award figures include the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation represents health insurance costs paid by the Company.
2Dr. Donini deferred the payment of her 2017 bonus of $44,933 until January 15, 2018. Option award figures include the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation represents health insurance costs paid by the Company.
3Ms. Krumeich deferred the payment of her 2017 bonus of $44,835 until January 15, 2018. Option award figures include the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation represents health insurance costs paid by the Company.
4Dr. Straube deferred the payment of his 2017 bonus of $56,213 until January 15, 2018. Option award figures include the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation represents health insurance costs paid by the Company.
Employment and Severance Agreements
In August 2006, we entered into a three-year employment agreement with Christopher J. Schaber, PhD. Pursuant to this employment agreement we agreed to pay Dr. Schaber a base salary of $300,000 per year and a minimum annual bonus of $100,000. Dr. Schaber’s employment agreement automatically renews every three years, unless otherwise terminated, and last was automatically renewed in December 2007, December 2010, December 2013 and December 20162019 for an additional term of three years. We agreed to issue him options to purchase 12,500833 shares of our common stock, with one third immediately vesting and the remainder vesting over three years. Upon termination without “Just Cause” as defined by this agreement, we would pay Dr. Schaber nine months of severance, as well as any accrued bonuses, accrued vacation, and we would provide health insurance and life insurance benefits for Dr. Schaber and his dependents. No unvested options shall vest beyond the termination date. Dr. Schaber’s monetary compensation (base salary of $300,000 and bonus of $100,000) remained unchanged from 2006 with the 2007 renewal. Upon a change in control of the Companycompany due to merger or acquisition, all of Dr. Schaber’s options shall become fully vested, and be exercisable for a period of five years after such change in control (unless they would have expired sooner pursuant to their terms). In the event of his death during the term of the agreement, all of his unvested options shall immediately vest and remain exercisable for the remainder of their term and become the property of Dr. Schaber’s immediate family.
In February 2007,January 2020, our Board of Directors authorized an amendment to Dr. Schaber’s employment agreement to increase the issuancenumber of 5,000 shares of common stock from 334 to 33,334, issuable to Dr. Schaber immediately prior to the completion of a transaction or series or a combination of related transactions negotiated by our Board of Directors whereby, directly or indirectly, a majority of our capital stock or a majority of our assets are transferred from the Companyus and/or our stockholders to a third party. The amended
In December 2020, our Board of Directors authorized an amendment to Dr. Schaber’s employment agreement withto modify the severance terms. Upon termination without “Just Cause” as defined by this agreement, we would pay Dr. Schaber includestwelve months of severance, as well as a pro rata bonus calculated by the average of his prior two year’s annual bonuses,
72
if any, and based on the number of months that he was employed during the year in which his employment was terminated; however, in the case of termination without “Just Cause” within one year following a change in control or the sale or other disposition of all or substantially all of our obligation to issue such shares toassets Dr. Schaber will be entitled 18 months of severance and health insurance and life insurance benefits for him if such event occurs.
and his dependents.
On June 22, 2011, the Compensation Committee eliminated his fixed minimum annual bonus payable and revised it to an annual targeted bonus of 40% of his annual base salary. On December 10, 2015,2021, the Compensation Committee approved an increase in salary for Dr. Schaber to $434,969.$499,496. On December 14, 2016,8, 2022, the Compensation Committee approved an increase in salary for Dr. Schaber to $443,668.$519,476. On December 7, 2017,8, 2023, the Compensation Committee approved an increase in salary for Dr. Schaber to $452,541.
$540,255.
In July 2013, we entered into a one-year employment agreement with Oreola Donini, PhD, our Vice President Preclinical Research & Development. Pursuant to the agreement, we have agreed to pay Dr. Donini $170,000 (CAD) per year and a targeted annual bonus of 20% of base salary. We also agreed to issueissued her options to purchase 40,0002,666 shares of our common stock with one-quarter immediately vesting and the remainder vesting over three years. Dr. Donini’s employment agreement automatically renews each year, unless otherwise terminated, and has automatically renewed each year since execution. Upon termination without “Just Cause”, as defined in Dr. Donini’s employment agreement, we would pay Dr. Donini three months of severance, accrued bonuses and vacation, and health insurance benefits. No unvested options vest beyond the termination date. In December 2014, Dr. Donini was named Chief Scientific Officer and Senior Vice President. Upon Dr. Donini’s promotion to Chief Scientific Officer, the Compensation Committee increased her targeted bonus to 30% of her annual base salary. On December 10, 2015,2021, the Compensation Committee approved an increase in salary for Dr. Donini to $202,400.$280,800. On December 14, 2016,8, 2022, the Compensation Committee approved an increase in salary for Dr. Donini to $220,000.$300,000. On December 7, 2017,8, 2023, the Compensation Committee approved an increase in salary for Dr. Donini to $230,000.
$312,000.
In December 2014, we entered into a one-year employment agreement with Richard C. Straube, MD, our Chief Medical Officer and Senior Vice President. Pursuant to the agreement, we have agreed to pay Dr. Straube $300,000 per year and a targeted annual bonus of 30% of base salary. We also agreed to issueissued him options to purchase 10,000666 shares of our common stock with one-third immediately vesting and the remainder vesting over three years. On March 26, 2019, we entered into an amendment to our employment agreement with Dr. Straube’sStraube. Pursuant to the amended agreement, which amendment becomes effective as of April 1, 2019, Dr. Straube will be required to devote at least 20 hours per week to the performance of his duties and we will pay him $170,000 per year. The amended employment agreement automatically renews each year, unless otherwise terminated, and has automatically renewed each year since execution.terminated. Upon termination without “Just Cause”, as defined in Dr. Straube’sthe amended employment agreement, we would pay Dr. Straube one month of severance. No unvested options vest beyond the termination date. On December 10, 2021, the Compensation Committee approved an increase in salary for Dr. Straube to $182,174. On December 8, 2022, the Compensation Committee approved an increase in salary for Dr. Straube to $189,461. On December 8, 2023, the Compensation Committee approved an increase in salary for Dr. Straube to $197,039.
On September 9, 2019, we entered into a one-year employment agreement with Jonathan Guarino, CPA, CGMA, our Senior Vice President and Chief Financial Officer. Pursuant to the agreement, we agreed to pay Mr. Guarino $220,000 per year and a targeted annual bonus of 30% of base salary. We also issued him options to purchase 2,666 shares of our common stock with one-quarter immediately vesting and the remainder vesting over three years. Mr. Guarino’s employment agreement automatically renews each year, unless otherwise terminated. Upon termination without “Just Cause”, as defined in Mr. Guarino’s employment agreement, we would pay Mr. Guarino three months of severance, accrued salary, bonuses and vacation, and health insurance benefits. No unvested options vest beyond the termination date. On December 10, 2015,2021, the Compensation Committee approved an increase in salary for Dr. StraubeMr. Guarino to $316,725.$231,132. On December 14, 2016,8, 2022, the Compensation Committee approved an increase in salary for Dr. StraubeMr. Guarino to $323,060.$245,000. On December 7, 2017,8, 2023, the Compensation Committee approved an increase in salary for Dr. StraubeMr. Guarino to $329,521.$254,800.
On June 16, 2016, we entered into a one-year employment agreement with Karen Krumeich, our Senior Vice President and Chief Financial Officer. Pursuant to the agreement, we have agreed to pay Ms. Krumeich $222,000 per year and a targeted annual bonus of 30% of base salary. We also agreed to issue her options to purchase 10,000 shares of our common stock with one-quarter immediately vesting and the remainder vesting over three years. Ms. Krumeich’s employment agreement automatically renews each year, unless otherwise terminated. Upon termination without “Just Cause”, as defined in Ms. Krumeich’s employment agreement, we would pay Ms. Krumeich three months of severance, accrued bonuses and vacation, and health insurance benefits. No unvested options vest beyond the termination date. On December 14, 2016, the Compensation Committee approved an increase in salary for Ms. Krumeich to $226,440. On December 7, 2017, the Compensation Committee approved an increase in salary for Ms. Krumeich to $230,969.
73
Outstanding Equity Awards at Fiscal Year-End
The following table contains information concerning unexercised options, stock that has not vested, and equity incentive plan awards for the Named Executive Officers outstanding at December 31, 2017, as adjusted for the reverse stock split of one-for-ten effective October 7, 2016.2023. We have never issued Stock Appreciation Rights.
| | | | | | | | | | | |
|
| |
|
|
| Equity |
|
| |
|
|
| | | | | | Incentive Plan | | | | | |
| | | | | | Awards: | | | | | |
| | | | | | Number of | | | | | |
| | | | | | Securities | | | | | |
| | Number of Securities | | Underlying | | Option | | | |||
| | Underlying Unexercised | | Unexercised | | Exercise | | Option | |||
| | Options (#) | | Unearned | | Price | | Expiration | |||
Name | | Exercisable | | Unexercisable | | Options (#) | | ($) | | Date | |
Christopher J. Schaber |
| 666 |
| — |
| — | | $ | 225.00 |
| 12/04/2024 |
|
| 933 |
| — |
| — | | $ | 169.50 |
| 12/30/2025 |
|
| 4,000 |
| — |
| — | | $ | 30.15 |
| 12/06/2027 |
|
| 4,000 |
| — |
| — | | $ | 14.55 |
| 12/12/2028 |
|
| 4,000 |
| — |
| — | | $ | 14.40 |
| 01/01/2029 |
|
| 4,000 |
| — |
| — | | $ | 18.60 |
| 12/11/2029 |
| | 4,000 | | — | | — | | $ | 21.75 | | 01/01/2030 |
| | 4,000 | | — | | — | | $ | 35.10 | | 12/09/2030 |
|
| 3,750 |
| 250 |
| 250 | | $ | 19.20 |
| 01/03/2031 |
|
| 3,000 |
| 1,000 |
| 1,000 | | $ | 11.70 |
| 12/08/2031 |
| | 845 | | — | | — | | $ | 10.35 | | 01/02/2032 |
| | 1,905 | | 1,249 | | 1,249 | | $ | 10.35 | | 01/02/2032 |
| | 4,670 | | 4,663 | | 4,663 | | $ | 8.10 | | 12/07/2032 |
| | 37,500 | | 112,500 | | 112,500 | | $ | 0.67 | | 12/07/2033 |
| | | | | | | | | | | |
Jonathan Guarino |
| 2,666 |
| — |
| — | | $ | 14.55 |
| 09/08/2029 |
|
| 666 |
| — |
| — | | $ | 18.60 |
| 12/11/2029 |
|
| 2,666 |
| — |
| — | | $ | 35.10 |
| 12/09/2030 |
| | 2,297 | | 1,036 | | 1,036 | | $ | 11.70 | | 12/08/2031 |
| | 2,670 | | 2,663 | | 2,663 | | $ | 8.10 | | 12/07/2032 |
| | 22,500 | | 67,500 | | 67,500 | | $ | 0.67 | | 12/07/2033 |
| | | | | | | | | | | |
Oreola Donini |
| 200 |
| — |
| — | | $ | 225.00 |
| 12/04/2024 |
|
| 466 |
| — |
| — | | $ | 169.50 |
| 12/30/2025 |
|
| 1,333 |
| — |
| — | | $ | 40.05 |
| 03/30/2027 |
|
| 2,333 |
| — |
| — | | $ | 30.15 |
| 12/06/2027 |
|
| 2,666 |
| — |
| — | | $ | 14.55 |
| 12/12/2028 |
|
| 4,000 |
| — |
| — | | $ | 18.60 |
| 12/11/2029 |
|
| 4,666 |
| — |
| — | | $ | 35.10 |
| 12/09/2030 |
| | 3,503 | | 1,163 | | 1,163 | | $ | 11.70 | | 12/08/2031 |
| | 2,670 | | 2,663 | | 2,663 | | $ | 8.10 | | 12/07/2032 |
| | 22,500 | | 67,500 | | 67,500 | | $ | 0.67 | | 12/07/2033 |
| | | | | | | | | | | |
Richard C. Straube |
| 666 |
| — |
| — | | $ | 301.50 |
| 01/06/2024 |
|
| 333 |
| — |
| — | | $ | 225.00 |
| 12/04/2024 |
|
| 466 |
| — |
| — | | $ | 169.50 |
| 12/30/2025 |
|
| 1,333 |
| — |
| — | | $ | 40.05 |
| 03/30/2027 |
|
| 2,333 |
| — |
| — | | $ | 30.15 |
| 12/06/2027 |
|
| 2,666 |
| — |
| — | | $ | 14.55 |
| 12/12/2028 |
|
| 2,000 |
| — |
| — | | $ | 18.60 |
| 12/11/2029 |
| | 2,666 | | — | | — | | $ | 35.10 | | 12/09/2030 |
| | 2,003 |
| 663 |
| 663 | | $ | 11.70 |
| 12/08/2031 |
| | 2,670 | | 2,663 | | 2,663 | | $ | 8.10 | | 12/07/2032 |
| | 18,750 | | 56,250 | | 56,250 | | $ | 0.67 | | 12/07/2033 |
|
| | | | | | | | | | |
74
| Name | Number of Securities (#) | Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned | Option Exercise Price | Option Expiration | ||||||||||||||||
| Exercisable | Unexercisable | Options(#) | ($) | Date | ||||||||||||||||
| Christopher J. Schaber | 2,500 | - | - | $ | 54.00 | 8/9/2017 | ||||||||||||||
| 4,500 | - | - | $ | 94.00 | 8/9/2017 | |||||||||||||||
| 14,000 | - | - | $ | 12.00 | 12/17/2018 | |||||||||||||||
| 11,000 | - | - | $ | 46.40 | 6/30/2020 | |||||||||||||||
| 11,219 | - | - | $ | 6.40 | 11/30/2021 | |||||||||||||||
| 13,000 | - | - | $ | 6.80 | 12/04/2022 | |||||||||||||||
| 10,000 | - | - | $ | 20.10 | 12/04/2023 | |||||||||||||||
| 10,000 | - | - | $ | 15.00 | 12/04/2024 | |||||||||||||||
| 10,500 | 3,500 | 3,500 | $ | 11.30 | 12/30/2025 | |||||||||||||||
| 21,875 | 28,125 | 28,125 | $ | 2.67 | 3/30/2027 | |||||||||||||||
| 20,000 | 60,000 | 60,000 | $ | 2.01 | 12/6/2027 | |||||||||||||||
| Oreola Donini | 4,000 | - | $ | 15.60 | 8/14/2023 | |||||||||||||||
| 2,000 | - | $ | 20.10 | 12/4/2023 | ||||||||||||||||
| 3,000 | - | $ | 15.00 | 12/4/2024 | ||||||||||||||||
| 7,000 | 1,746 | 1,746 | $ | 11.30 | 12/30/2025 | |||||||||||||||
| 20,000 | 11,250 | 11,250 | $ | 2.67 | 3/30/2027 | |||||||||||||||
| 35,000 | 26,250 | 26,250 | $ | 2.01 | 12/6/2027 | |||||||||||||||
| Richard C. Straube | 10,000 | - | - | $ | 20.10 | 1/06/2024 | ||||||||||||||
| 5,000 | - | - | $ | 15.00 | 12/04/2024 | |||||||||||||||
| 5,254 | 1,746 | 1,746 | $ | 11.30 | 12/30/2025 | |||||||||||||||
| 8,750 | 11,250 | 11,250 | $ | 2.67 | 3/30/2027 | |||||||||||||||
| 8,750 | 26,250 | 26,250 | $ | 2.01 | 12/6/2027 | |||||||||||||||
| Karen Krumeich | 6,250 | 3,750 | 3,750 | $ | 7.40 | 6/15/2026 | ||||||||||||||
| 8,750 | 11,250 | 11,250 | $ | 2.67 | 3/30/2027 | |||||||||||||||
| 8,750 | 26,250 | 26,250 | $ | 2.01 | 12/6/2027 | |||||||||||||||
Compensation of Directors
The following table contains information concerning the compensation of the non-employee directors during the fiscal year ended December 31, 2017.2023.
| Name | Fees Earned Paid in Cash1 | Option Awards2 | Total | |||||||||
| Keith L .Brownlie | $ | 55,000 | $ | 30,000 | $ | 85,000 | ||||||
| Marco M. Brughera | $ | 40,000 | $ | 30,000 | $ | 70,000 | ||||||
| Gregg A. Lapointe | $ | 47,500 | $ | 30,000 | $ | 77,500 | ||||||
| Robert J. Rubin | $ | 52,500 | $ | 30,000 | $ | 82,500 | ||||||
| Jerome B. Zeldis | $ | 50,000 | $ | 30,000 | $ | 80,000 | ||||||
| | | | | | | | | |
|
| Fees Earned |
| | |
|
| | |
| | Paid in Cash | | Option | | | | ||
Name | | (1) | | Awards (2) | | Total | |||
Gregg A. Lapointe | | $ | 55,000 | | $ | 22,500 | | $ | 77,500 |
Diane L. Parks | | $ | 47,500 | | $ | 22,500 | | $ | 70,000 |
Robert J. Rubin | | $ | 57,500 | | $ | 22,500 | | $ | 80,000 |
Jerome B. Zeldis | | $ | 50,000 | | $ | 22,500 | | $ | 72,500 |
Timothy Cote (3) | | $ | 6,435 | | $ | 21,300 | | $ | 27,735 |
| (1) | Directors who are compensated as full-time employees receive no additional compensation for service on our Board of Directors. Each independent director who is not a full-time employee is paid $35,000 annually, on a prorated basis, for their service on our Board of Directors, the chairman of our Audit Committee is paid $15,000 annually, on a prorated basis, and the chairmen of our Compensation and Nominating Committees |
| (2) | We maintain a stock option grant program pursuant to the nonqualified stock option plan, whereby members of our Board of Directors or its committees who are not full-time employees receive an initial grant of fully vested options to purchase |
| (3) | Dr.Cote was appointed by our Board of Directors in May2023 and resigned, for personal reasons, as a member of our Board of Directors on July7, 2023. |
Stock Ownership Policy
In April 2012, our Board of Directors adopted a stock ownership policy applicable to our non-employee directors to strengthen the link between director and stockholder interests. Pursuant to the stock ownership policy, each non-employee director is required to hold a minimum ownership position in the common stock equal to the annual cash compensation paid for service on the Board of Directors, exclusive of cash compensation paid for service as a chair or member of any committees of the Board of Directors.
Stock counted toward the ownership requirement includes common stock held by the director, unvested and vested restricted stock, and all shares of common stock beneficially owned by the director held in a trust and by a spouse and/or minor children of the director. The policy provides that the ownership requirement must be attained within three years after the later of June 21, 2012 and the date a director is first elected or appointed to the Board of Directors. To monitor progress toward meeting the requirement, the Nominating Committee will review director ownership levels at the end of March of each year. Non-employee directors are prohibited from selling any shares of common stock unless such director is in compliance with the stock ownership policy. A copy of our director compensation and stock ownership policy is publicly available on our website atwww.soligenix.com under the “Investors” section.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The table below provides information regarding the beneficial ownership of the common stock as of March 9, 2018,8, 2024, of (1) each person or entity who owns beneficially 5% or more of the shares of our outstanding common stock, (2) each of our directors, (3) each of the Named Executive Officers, and (4) our directors and officers as a group. Except as otherwise indicated, and subject to applicable community property laws, we believe the persons named in the table have sole voting and investment power with respect to all shares of common stock held by them.
Beneficial Ownership
| Name of Beneficial Owner | Shares of Common Stock Beneficially Owned | Percent of Class | ||||||
| ACT Capital Management, LLLP(1) | 872,000 | 9.98 | % | |||||
| Knoll Capital Management, LP(2) | 870,000 | 9.95 | % | |||||
| Christopher J. Schaber(3) | 175,940 | 1.98 | % | |||||
| Keith L. Brownlie(4) | 25,899 | * | ||||||
| Marco M. Brughera(5) | 23,237 | * | ||||||
| Gregg A. Lapointe(6) | 29,529 | * | ||||||
| Robert J. Rubin(7) | 32,615 | * | ||||||
| Jerome B. Zeldis(8) | 26,982 | * | ||||||
| Richard Straube(9) | 41,630 | * | ||||||
| Oreola Donini(10) | 35,630 | * | ||||||
| Karen Krumeich(11) | 29,113 | * | ||||||
| All directors and executive officers as a group (9 persons) | 420,575 | 4.62 | % | |||||
| | | | | |
|
| Shares of |
|
|
|
| | Common | | |
|
| | Stock | | |
|
| | Beneficially | | Percent |
|
Name of Beneficial Owner | | Owned ** | | of Class |
|
Christopher J. Schaber (1) |
| 84,863 |
| * | |
Gregg A. Lapointe (2) |
| 20,682 |
| * | |
Diane L. Parks (3) |
| 19,623 |
| * | |
Robert J. Rubin (4) |
| 20,483 |
| * | |
Jerome B. Zeldis (5) |
| 21,718 |
| * | |
Jonathan Guarino (6) |
| 36,149 |
| * | |
Oreola Donini (7) | | 46,370 | | * | |
Richard Straube (8) | | 37,427 | | * | |
All directors and executive officers as a group (8 persons) (9) |
| 287,315 |
| 2.66 | % |
| (1) | |
| Includes |
75
| Includes |
| Includes |
| (4) | Includes 293 shares of common stock and |
| Includes |
| Includes |
| (7) | Includes options to purchase 46,370 shares of common stock exercisable within 60 days of March 8, 2024. The address of Dr. Donini is c/o Soligenix, 29 Emmons Drive, Suite B-10, Princeton, New Jersey 08540. |
| (8) | Includes 534 shares of common stock and options to purchase 36,893 shares of common stock exercisable within 60 days of March 8, 2024. The address of Dr. Straube is c/o Soligenix, 29 Emmons Drive, Suite B-10, Princeton, New Jersey 08540. |
| Includes |
* | Indicates less than 1%. |
** | Beneficial ownership is determined in accordance with the rules of the SEC. Shares of common stock subject to options or warrants currently exercisable or exercisable within 60 days of March |
* Indicates less than 1%.
** Beneficial ownership is determined in accordance with the rules of the SEC. Shares of common stock subject to options or warrants currently exercisable or exercisable within 60 days of March 9, 2018 are deemed outstanding for computing the percentage ownership of the stockholder holding the options or warrants, but are not deemed outstanding for computing the percentage ownership of any other stockholder. Percentage of ownership is based on XX shares of common stock outstanding as of March 9, 2018.
Equity Compensation Plan Information
In December 2005, our Board of Directors approved the 2005 Equity Incentive Plan, which was approved by stockholders on December 29, 2005. In September 2013, our stockholders approved an amendment to the 2005 Equity Incentive Plan to increase theThe maximum number of shares of our common stock available for issuance under the plan by 125,000 shares, bringing the total shares reserved for issuance under the plan to2005 Equity Incentive Plan is 300,000 shares. In April 2015, our Board of Directors approved the 2015 Equity Incentive Plan, which was approved by stockholders on June 18, 2015. AsOn September 22, 2022, the stockholders approved an amendment to the 2015 Plan to increase the maximum numbers of June 8, 2017, a maximum of 600,000 shares of our common stock are available for issuance under the plan from 2,000,000 to 6,000,000 shares. As of December 31, 2023, there are 5,096,447 shares currently available for future grants under the 2015 Equity Incentive Plan.
The following table providessets forth certain information, as of December 31, 20172023, with respect to options outstanding under our 2005 Equity Incentive Plan and our 2015 Equity Incentive Plan. All share numbers in this paragraph and in the following table have been adjustedcompensation plans (including individual compensation arrangements) under which our equity securities are authorized for the one-for-ten reverse stock split effective October 7, 2016.
| Plan Category | Number of Securities to be Issued upon Exercise of Outstanding Options, Warrants and Rights | Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights | Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (excluding securities reflected in the first column) | |||||||||
Equity compensation plans approved by security holders1 | 785,655 | $ | 7.15 | 13,969 | ||||||||
| Equity compensation plans not approved by security holders | - | - | - | |||||||||
| Total | 785,655 | $ | 7.15 | 13,969 | ||||||||
issuance:
| ● |
| ● | all compensation plans not previously approved by our security holders. |
76
| | | | | | | |
|
| |
|
| |
| Number of |
| | | | | | | Securities |
| | | | | | | Remaining |
| | | | | | | Available for |
| | | | | | | Future |
| | Number of | | | | | Issuance |
| | Securities to | | Weighted- | | Under Equity | |
| | be Issued | | Average | | Compensation | |
| | upon Exercise | | Exercise | | Plans | |
| | of | | Price of | | (excluding | |
| | Outstanding | | Outstanding | | securities | |
| | Options, | | Options, | | reflected in | |
| | Warrants and | | Warrants and | | the first | |
Plan Category | | Rights | | Rights | | column) | |
Equity compensation plans approved by security holders (1) |
| 906,892 | | $ | 5.73 |
| 5,096,447 |
Equity compensation plans not approved by security holders |
| — | |
| — |
| — |
Total |
| 906,892 | | $ | 5.73 |
| 5,096,447 |
| (1) | Includes our 2005 Equity Incentive Plan and our 2015 Equity Incentive Plan. Our 2005 Equity Incentive Plan expired in 2015 and thus no securities remain available for future issuance under that plan. |
Item 13. Certain Relationships and Related Transactions and Director Independence
Related Party Transactions
Our audit committee is responsible for the review, approval and ratification of related party transactions. The audit committee reviews these transactions under our Code of Ethics, which governs conflicts of interests, among other matters, and is applicable to our employees, officers and directors.
We are party to a registration rights agreement with certain stockholders, including ACT Capital Management, LLLP, and Knoll Capital Management, LP, each of which beneficially owns 5% or more of the shares of our outstanding common stock.stockholders. The agreement provides that the stockholders have the right to require that we register its shares under the Securities Act of 1933 (the “Securities Act”) for sale to the public, subject to certain conditions. The stockholders also have piggyback registration rights, which means that, if not already registered, they have the right to include their shares in any registration that we effect under the Securities Act, subject to specified exceptions. We must pay all expenses incurred in connection with the exercise of these demand registration rights.
We are unable to estimate the dollar value of the registration rights to the holders of these rights. The amount of reimbursable expenses under the agreements depends on a number of variables, including whether registration rights are exercised incident to a primary offering by us, the form on which we are eligible to register such a transaction, and whether we have a shelf registration in place at the time of a future offering.
On April 27, 2023, we entered into an exclusive option agreement with Silk Road Therapeutics, Inc. ("Silk Road"), pursuant to which Silk Road granted us an exclusive option to purchase all assets and rights, including intellectual property and regulatory documents, related to Silk Road’s PTX product candidate, a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient’s suffering from Behçet’s Disease (“BD”). The option agreement expired on August 25, 2023. In consideration for the option, we paid $50,000 of cash and issued 31,646 shares of common stock with a value of $50,000. The consideration paid for the option was recorded as general and administrative expense on the accompanying consolidated statements of operations. As of August 25, 2023, we concluded our due diligence activities and decided to allow the option to expire. A member of our Board of Directors has an ownership interest in Silk Road.
Other than as described above, the employment agreements and compensation paid to our directors, we did not engage in any other transactions with related parties since January 1, 2017.2022. For a discussion of our employment agreements and compensation paid to our directors, see “Item 11. Executive Compensation”.Compensation.”
Director Independence
The Board of Directors has determined that Messrs. Brownlie andMr. Lapointe, Dr. Brughera,Ms. Parks, Dr. Rubin, and Dr. Zeldis are “independent” as such term is defined by the applicable listing standards of Nasdaq. Our Board of Directors based this determination primarily on a review of the responses of the Directors to questionnaires regarding their employment, affiliations and family and other relationships.
77
Item 14. Principal Accountant Fees and Services
The following table highlights the aggregate fees billed during each of the two years ended December 31, 20172023 and 2022 by EisnerAmperCherry Bekaert LLP.
| 2017 | 2016 | |||||||||||||
| | | | | | | ||||||||
|
| 2023 |
| 2022 | ||||||||||
| Audit fees | $ | 194,975 | $ | 237,563 | | $ | 59,870 | | $ | — | ||||
| Tax fees | 9,660 | 9,660 | ||||||||||||
| Other fees | - | - | ||||||||||||
| Total | $ | 204,635 | $ | 247,223 | | $ | 59,870 | | $ | — | ||||
Audit Fees
This category includes the fees for the examination of our consolidated financial statements, review of our Annual Report on Form 10-K and quarterly reviews of the interim financial statements included in our Quarterly Reports on Form 10-Q.
Tax Fees
Our principal accountants did not bill us for any services for tax compliance, tax advice and tax planning.
Other Fees
Our principal accountants did not bill us for any services or products other than as reported above in this Item 14 during each of the two years.
Pre-Approval Policies and Procedures
The audit committee has adopted a policy that requires advance approval of all audit services and permitted non-audit services to be provided by the independent auditor as required by the Exchange Act. The audit committee must approve the permitted service before the independent auditor is engaged to perform it. The audit committee approved all of the services described above in accordance with its pre-approval policies and procedures.
Item 15. Exhibits and Financial Statements Schedules
| (1)Consolidated Financial Statements: |
The financial statements required to be filed by Item 8 of this Annual Report on Form 10-K and filed in this Item 15, are as follows:
| (2) | Financial Statement Schedules |
Schedules are omitted because they are not applicable, or are not required, or because the information is included in the consolidated financial statements and notes thereto.
78
| (3) | Exhibits: |
| |
| |
10.1 |
79
| |
10.13 |
80
| |
10.22 | |
| |
10.23 | |
| |
10.24 | |
| |
10.25 | |
| |
10.26 | |
| |
10.27 | |
| |
10.28 | |
| |
10.29 | |
| |
10.30 | |
| |
10.31 | |
| |
19.1 | |
| |
21.1 | |
| |
23.1 | |
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23.2 | |
| |
31.1 | |
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31.2 | |
| |
32.1 | |
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81
32.2 | |
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97 | |
| |
101.INS | Inline XBRL Instance Document |
| |
101.SCH | Inline XBRL Taxonomy Extension Schema Document |
| |
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| |
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document |
| |
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document |
| |
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| |
104 | Cover Page Interactive Data File – The cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
*
| Filed herewith. |
** | Indicates management contract or compensatory plan. |
† | Portions of this exhibit have been omitted pursuant to a request for confidential treatment. |
82
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| | |
| SOLIGENIX, INC. | |
| By: | |
/s/ Christopher J. Schaber | ||
| | Christopher J. Schaber, PhD |
| | Chief Executive Officer and President |
| | |
Date: March 15, 2024 | | |
In accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities indicated and on the dates indicated.
| | | | |
Name | Capacity | Date | ||
| | | | |
| | Chairman of the Board, Chief Executive Officer | | |
/s/ Christopher J. Schaber | | and | | March 15, |
Christopher J. Schaber, PhD | | President (principal executive officer) | | |
| | | | |
/s/ Gregg A. Lapointe | | Director | | March 15, |
Gregg A. Lapointe, CPA | | | | |
| | | | |
/s/ Diane L. Parks | | Director | | March 15, 2024 |
Diane L. Parks, MBA | | | | |
| | | | |
/s/ Robert J. Rubin | | Director | | March 15, |
Robert J. Rubin, MD | | | | |
| | | | |
/s/ Jerome B. Zeldis | | Director | | March 15, |
Jerome B. Zeldis, MD, PhD | | | | |
| | | | |
/s/ | | Chief Financial Officer, Senior Vice President, and | | March 15, |
Jonathan Guarino, CPA, CGMA | | Corporate Secretary (principal accounting officer) | | |
83
SOLIGENIX, INC. AND SUBSIDIARIES
CONSOLIDATED FINANCIAL STATEMENTS
Table of Contents
| |
| |
| Page |
Consolidated Balance Sheets as of December 31, | F-2 |
Consolidated Statements of Operations for the Years Ended December 31, | F-3 |
F-4 | |
F-5 | |
Consolidated Statements of Cash Flows for the Years Ended December 31, | |
F-6 | |
F-7 – F-24 | |
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 00677) | F-26 |
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 00274) | F-28 |
F-1
Soligenix, Inc. and Subsidiaries
Consolidated Balance Sheets
As of December 31, 2023 and 2022
| 2017 | 2016 | |||||||
Assets Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,809,487 | $ | 8,772,567 | ||||
| Contracts and grants receivable | 926,251 | 1,206,777 | ||||||
| Prepaid expenses | 263,254 | 134,431 | ||||||
| Income tax receivable | 416,810 | - | ||||||
| Total current assets | 9,415,802 | 10,113,775 | ||||||
| Security deposit | 22,734 | - | ||||||
| Office furniture and equipment, net | 37,163 | 26,702 | ||||||
| Intangible assets, net | 73,952 | 126,628 | ||||||
| Total assets | $ | 9,549,651 | $ | 10,267,105 | ||||
| Liabilities and shareholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,753,614 | $ | 1,708,091 | ||||
| Accrued expenses | 1,143,306 | 806,118 | ||||||
| Accrued compensation | 333,019 | 355,648 | ||||||
| Total current liabilities | 3,229,939 | 2,869,857 | ||||||
| Commitments and contingencies | ||||||||
| Shareholders’ equity: | ||||||||
| Preferred stock: 350,000 shares authorized; none issued or outstanding | - | - | ||||||
| Common stock, $.001 par value; 25,000,000 and 10,000,000 shares authorized at December 31, 2017 and 2016, respectively; 8,730,640 and 5,470,032 shares issued and outstanding in 2017 and 2016, respectively | 8,731 | 5,470 | ||||||
| Additional paid-in capital | 163,581,026 | 157,514,740 | ||||||
| Accumulated deficit | (157,270,045 | ) | (150,122,962 | ) | ||||
| Total shareholders’ equity | 6,319,712 | 7,397,248 | ||||||
| Total liabilities and shareholders’ equity | $ | 9,549,651 | $ | 10,267,105 | ||||
| | | | | | |
| | December 31, | | December 31, | ||
|
| 2023 |
| 2022 | ||
Assets |
| |
| |
| |
Current assets: |
| |
|
| |
|
Cash and cash equivalents | | $ | 8,446,158 | | $ | 13,359,615 |
Contracts and grants receivable | |
| — | |
| 115,130 |
Unbilled revenue | | | 171,254 | | | — |
Research and development incentives receivable, current | |
| 23,894 | |
| 104,198 |
Prepaid expenses and other current assets | |
| 866,014 | |
| 274,209 |
Total current assets | |
| 9,507,320 | |
| 13,853,152 |
Security deposit | |
| 22,777 | |
| 22,777 |
Office furniture and equipment, net of accumulated depreciation of $121,320 and $114,766 | |
| 11,927 | |
| 18,481 |
Deferred issuance cost | |
| — | |
| 20,206 |
Right-of-use lease assets | |
| 229,834 | |
| 340,987 |
Research and development incentives receivable, net of current portion | |
| 25,468 | |
| 24,114 |
Total assets | | $ | 9,797,326 | | $ | 14,279,717 |
| | | | | | |
Liabilities, mezzanine equity and shareholders' equity/(deficit) | |
|
| |
|
|
Current liabilities: | |
|
| |
|
|
Accounts payable | | $ | 1,111,226 | | $ | 3,865,796 |
Accrued expenses | |
| 2,418,002 | |
| 2,307,746 |
Accrued compensation | |
| 251,115 | |
| 336,692 |
Lease liabilities, current | |
| 121,765 | |
| 108,948 |
Convertible debt, net of debt discount of $0 and $102,309 | | | 2,250,000 | | | 9,897,691 |
Total current liabilities | |
| 6,152,108 | |
| 16,516,873 |
Non-current liabilities: | |
|
| |
|
|
Convertible debt | |
| 1,010,934 | |
| — |
Lease liabilities, net of current portion | |
| 111,862 | |
| 233,627 |
Total liabilities | |
| 7,274,904 | |
| 16,750,500 |
| | | | | | |
Commitments and contingencies (Note 10) | |
|
| |
|
|
| | | | | | |
Mezzanine equity: | | | | | | |
Series D preferred stock, $.001 par value; 0 and 50,000 shares authorized, none issued or outstanding as of December 31, 2023 and December 31, 2022, respectively | | | — | | | 43 |
| | | | | | |
Shareholders’ equity/(deficit): | |
|
| |
|
|
Preferred stock, 350,000 and 300,000 shares authorized as of December 31, 2023 and December 31, 2022, respectively; none issued or outstanding | | | — | | | — |
Common stock, $.001 par value; 75,000,000 shares authorized; 10,378,238 and 2,908,578 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | |
| 10,378 | |
| 2,909 |
Additional paid-in capital | |
| 228,193,977 | |
| 217,064,964 |
Accumulated other comprehensive income | |
| 22,243 | |
| 24,747 |
Accumulated deficit | |
| (225,704,176) | |
| (219,563,446) |
Total shareholders’ equity/(deficit) | |
| 2,522,422 | |
| (2,470,826) |
Total liabilities, mezzanine equity and shareholders’ equity/(deficit) | | $ | 9,797,326 | | $ | 14,279,717 |
The accompanying notes are an integral part of these consolidated financial statements.
F-2
Soligenix, Inc. and Subsidiaries
Consolidated Statements of Operations
For the Years Ended December 31, 2023 and 2022
| 2017 | 2016 | |||||||
| Revenues: | ||||||||
| Contract revenue | $ | 4,749,294 | $ | 10,448,794 | ||||
| Grant revenue | 683,178 | - | ||||||
| Total revenues | 5,432,472 | 10,448,794 | ||||||
| Cost of revenues | (4,310,083 | ) | (8,433,671 | ) | ||||
| Gross profit | 1,122,389 | 2,015,123 | ||||||
| Operating expenses: | ||||||||
| Research and development | 5,507,033 | 4,295,867 | ||||||
| General and administrative | 3,209,155 | 3,428,838 | ||||||
| Total operating expenses | 8,716,188 | 7,724,705 | ||||||
| Loss from operations | (7,593,799 | ) | (5,709,582 | ) | ||||
| Other income: | ||||||||
| Change in fair value of warrant liability | - | 1,541,241 | ||||||
| Gain on settlement liability | - | 390,599 | ||||||
| Interest income, net of expense | 29,906 | 2,216 | ||||||
| Total other income | 29,906 | 1,934,056 | ||||||
| Net loss before income taxes | (7,563,893 | ) | (3,775,526 | ) | ||||
| Income tax benefit | 416,810 | 530,143 | ||||||
| Net loss | $ | (7,147,083 | ) | $ | (3,245,383 | ) | ||
| Basic net loss per share | $ | (1.16 | ) | $ | (0.93 | ) | ||
| Diluted net loss per share | $ | (1.16 | ) | $ | (1.34 | ) | ||
| Basic weighted average common shares outstanding | 6,144,237 | 3,481,460 | ||||||
| Diluted weighted average common shares outstanding | 6,144,237 | 3,583,587 | ||||||
| | | | | | |
| | Year Ended | ||||
| | December 31, | ||||
|
| 2023 |
| 2022 | ||
Revenues: |
| |
|
| |
|
Licensing revenue | | $ | — | | $ | 250,000 |
Grant revenue | |
| 839,359 | |
| 698,911 |
Total revenues | |
| 839,359 | |
| 948,911 |
Cost of revenues | |
| (742,048) | |
| (550,822) |
Gross profit | |
| 97,311 | |
| 398,089 |
Operating expenses: | |
|
| |
|
|
Research and development | |
| 3,312,699 | |
| 7,944,089 |
General and administrative | |
| 4,482,552 | |
| 6,692,904 |
Total operating expenses | |
| 7,795,251 | |
| 14,636,993 |
Loss from operations | |
| (7,697,940) | |
| (14,238,904) |
Other income (expense): | |
|
| |
|
|
Foreign currency transaction gain (loss) | |
| 1,483 | |
| (30,549) |
Interest income (expense), net | |
| (49,129) | |
| (822,611) |
Research and development incentives | | | 23,784 | | | 132,869 |
CARES Act Employee Retention Credit | | | 120,771 | | | — |
Other income | | | 43,223 | | | 5,921 |
Loss on extinguishment of debt | |
| (393,791) | |
| — |
Change in fair value of convertible debt | | | 43,066 | | | — |
Total other income (expense) | | | (210,593) | | | (714,370) |
Net loss before income taxes | |
| (7,908,533) | |
| (14,953,274) |
Income tax benefit | |
| 1,767,803 | |
| 1,154,935 |
Net loss applicable to common stockholders | | $ | (6,140,730) | | $ | (13,798,339) |
Basic and diluted net loss per share | | $ | (0.79) | | $ | (4.81) |
Basic and diluted weighted average common shares outstanding | |
| 7,758,036 | |
| 2,871,345 |
The accompanying notes are an integral part of these consolidated financial statements.
F-3
Soligenix, Inc. and Subsidiaries
Consolidated Statements of Changes in Shareholders’ Equity
Comprehensive Loss
For the Years Ended December 31, 20172023 and 20162022
| Common Stock | Additional Paid–In | Accumulated | ||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||||||||||
| Balance, December 31, 2015 | 3,126,952 | $ | 3,127 | $ | 146,856,143 | $ | (146,877,579 | ) | $ | (18,309 | ) | |||||||||
| Issuance of common stock and warrants in public offering | 1,670,000 | 1,670 | 5,277,270 | - | 5,278,940 | |||||||||||||||
| Stock issuance costs associated with public offering | - | - | (809,277 | ) | - | (809,277 | ) | |||||||||||||
| Issuance of common stock pursuant to Lincoln Park Equity Line | 277,135 | 277 | 1,712,043 | - | 1,712,320 | |||||||||||||||
| Cost associated with Lincoln Park Equity Line | - | - | (41,381 | ) | - | (41,381 | ) | |||||||||||||
| Issuance of common stock in reverse stock split | 1,525 | 1 | - | - | 1 | |||||||||||||||
| Issuance of common stock to SciClone | 352,942 | 353 | 2,999,647 | - | 3,000,000 | |||||||||||||||
| Cashless exercise of warrants and reclassification of warrant liability to equity | 33,978 | 34 | 892,826 | - | 892,860 | |||||||||||||||
| Issuance of common stock to vendors | 7,500 | 8 | 52,492 | - | 52,500 | |||||||||||||||
| Share-based compensation expense | - | - | 574,977 | - | 574,977 | |||||||||||||||
| Net loss | - | - | - | (3,245,383 | ) | (3,245,383 | ) | |||||||||||||
Balance, December 31, 2016 | 5,470,032 | $ | 5,470 | $ | 157,514,740 | $ | (150,122,962 | ) | $ | 7,397,248 | ||||||||||
| Issuance of common stock pursuant to Lincoln Park Equity Line | 50,483 | 50 | 115,880 | - | 115,930 | |||||||||||||||
| Issuance of common stock pursuant to FBR At-the-Market Sales Agreement | 450,000 | 450 | 1,014,815 | - | 1,015,265 | |||||||||||||||
| Costs associated with FBR At-the-Market Sales Agreement | - | - | (164,825 | ) | - | (164,825 | ) | |||||||||||||
| Issuance of common stock from cashless exercise of warrants | 200,125 | 200 | (200 | ) | - | - | ||||||||||||||
| Issuance of common stock in concurrent public and private offerings | 2,557,500 | 2,558 | 5,112,443 | - | 5,115,001 | |||||||||||||||
| Costs associated with concurrent public and private offerings | - | - | (507,536 | ) | - | (507,536 | ) | |||||||||||||
| Issuance of common stock to vendors | 2,500 | 3 | 5,922 | - | 5,925 | |||||||||||||||
| Share-based compensation expense | - | - | 489,787 | - | 489,787 | |||||||||||||||
| Net loss | - | - | - | (7,147,083 | ) | (7,147,083 | ) | |||||||||||||
| Balance, December 31, 2017 | 8,730,640 | $ | 8,731 | $ | 163,581,026 | $ | (157,270,045 | ) | $ | 6,319,712 | ||||||||||
| | | | | | |
| | Year Ended | ||||
| | December 31, | ||||
|
| 2023 |
| 2022 | ||
Net loss | | $ | (6,140,730) | | $ | (13,798,339) |
Other comprehensive income (loss): | |
| | |
| |
Foreign currency translation adjustments | | | (2,504) | | | (17,195) |
Comprehensive loss | | $ | (6,143,234) | | $ | (13,815,534) |
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Soligenix, Inc. and Subsidiaries
Consolidated Statements of Cash FlowsChanges in Mezzanine Equity and Shareholders’ Equity (Deficit)
For the Years Ended December 31, 2023 and 2022
| 2017 | 2016 | |||||||
| Operating activities: | ||||||||
| Net loss | $ | (7,147,083 | ) | $ | (3,245,383 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Amortization and depreciation | 68,563 | 89,928 | ||||||
| Amortization of discount on debt | - | 7,281 | ||||||
| Share-based compensation | 489,787 | 574,977 | ||||||
| Gain on settlement of liability | - | (390,599 | ) | |||||
| Issuance of common stock for services | 5,925 | 52,500 | ||||||
| Change in fair value of warrant liability | - | (1,541,241 | ) | |||||
| Change in operating assets and liabilities: | ||||||||
| Contracts and grants receivable | 280,526 | 778,435 | ||||||
| Prepaid expenses | (128,823 | ) | 109,836 | |||||
| Security deposit | (22,734 | ) | - | |||||
| Income tax receivable | (416,810 | ) | - | |||||
| Accounts payable and accrued expenses | 382,711 | (1,475,128 | ) | |||||
| Accrued compensation | (22,629 | ) | 56,973 | |||||
| Total adjustments | 636,516 | (1,737,038 | ) | |||||
| Net cash used in operating activities | (6,510,567 | ) | (4,982,421 | ) | ||||
| Investing activities: | ||||||||
| Purchases of office furniture and equipment | (26,348 | ) | (7,159 | ) | ||||
| Net cash used in investing activities | (26,348 | ) | (7,159 | ) | ||||
| Financing activities: | ||||||||
| Proceeds from issuance of common stock and warrants pursuant to public and private offerings | 5,115,001 | 5,278,940 | ||||||
| Stock issuance costs associated with public and private offerings | (507,536 | ) | (809,277 | ) | ||||
| Proceeds from issuance of common stock pursuant to FBR At-the-Market Sales Agreement | 1,015,265 | - | ||||||
| Costs associated with FBR At-the-Market Sales Agreement | (164,825 | ) | - | |||||
| Proceeds from issuance of common stock pursuant to the equity line | 115,930 | 1,712,320 | ||||||
| Stock issuance cost associated with equity line | - | (41,381 | ) | |||||
| Repayment of notes payable | - | (300,000 | ) | |||||
| Proceeds from issuance of common stock to SciClone | - | 3,000,000 | ||||||
| Net cash provided by financing activities | 5,573,835 | 8,840,602 | ||||||
| Net increase (decrease) in cash and cash equivalents | (963,080 | ) | 3,851,022 | |||||
| Cash and cash equivalents at beginning of year | 8,772,567 | 4,921,545 | ||||||
| Cash and cash equivalents at end of year | $ | 7,809,487 | $ | 8,772,567 | ||||
| Supplemental disclosure of non cash financing activities: | ||||||||
| Reclassification of warrant liability to additional paid-in capital | $ | - | $ | 892,860 | ||||
| Supplemental information: | ||||||||
| Cash paid for state income taxes | $ | 5,077 | $ | 5,030 | ||||
| | | | | | | | | | | | | | | | | | | | | | | |
|
| | | | | | | |
|
| |
|
| |
| Accumulated |
|
| |
|
| | |
| | Mezzanine Equity- | | | | | | | | Additional | | Other | | | | | | | |||||
| | Series D Preferred Stock | | | Common Stock | | Paid–In | | Comprehensive | | Accumulated | | | | |||||||||
| | Shares | | Par Value |
|
| Shares | | Par Value | | Capital | | Income (Loss) | | Deficit | | Total | ||||||
Balance, December 31, 2021 |
| — | | $ | — | | | 2,858,244 | | $ | 2,859 | | $ | 216,442,904 | | $ | 41,942 | | $ | (205,765,107) | | $ | 10,722,598 |
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement |
| | | | | | | 8,542 | |
| 8 | |
| 79,346 | |
| — | |
| — | |
| 79,354 |
Issuance costs associated with B. Riley At Market Issuance Sales Agreement |
| | | | | | | — | | | — | | | (2,593) | |
| — | |
| — | |
| (2,593) |
Declaration of Series D preferred stock for stock dividend | | — | | | 43 | | | — | | | — | | | (43) | | | — | |
| — | | | (43) |
Fractional shares issued in reverse stock split | | | | | | | | 19,544 | | | 20 | | | (20) | | | — | |
| — | | | — |
Issuance of common stock to vendors |
| | | | | | | 22,248 | |
| 22 | |
| 211,981 | |
| — | |
| — | |
| 212,003 |
Share-based compensation expense |
| | | | | | | — | |
| — | |
| 333,389 | |
| — | |
| — | |
| 333,389 |
Foreign currency translation adjustment |
| | | | | | | — | |
| — | |
| — | |
| (17,195) | |
| — | |
| (17,195) |
Net loss |
| | | | | | | — | |
| — | |
| — | |
| — | |
| (13,798,339) | |
| (13,798,339) |
Balance, December 31, 2022 |
| — | | $ | 43 | | | 2,908,578 | | $ | 2,909 | | $ | 217,064,964 | | $ | 24,747 | | $ | (219,563,446) | | $ | (2,470,826) |
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement |
| | | | | | | 851,130 | |
| 851 | |
| 3,090,611 | |
| — | |
| — | |
| 3,091,462 |
Issuance costs associated with B. Riley At Market Issuance Sales Agreement |
| | | | | | | — | | | — | | | (113,217) | |
| — | |
| — | |
| (113,217) |
Redemption of Series D preferred stock | | — | | | (43) | | | — | | | — | | | — | | | — | | | — | | | — |
Issuance of common stock and pre-funded warrants in connection with May 2023 public offering | | | | | | | | 2,301,500 | | | 2,301 | | | 8,493,516 | | | — | | | — | | | 8,495,817 |
Issuance costs associated with May 2023 public offering | | | | | | | | — | | | — | | | (834,061) | | | — | | | — | | | (834,061) |
Issuance of common stock to vendors |
| | | | | | | 50,000 | |
| 50 | |
| 72,950 | |
| — | |
| — | |
| 73,000 |
Issuance of common stock upon exercise of pre-funded warrants | | | | | | | | 4,235,384 | | | 4,235 | | | (936) | | | — | | | — | | | 3,299 |
Issuance of common stock for unexercised purchase option | | | | | | | | 31,646 | | | 32 | | | 49,968 | | | — | | | — | | | 50,000 |
Share-based compensation expense |
| | | | | | | — | |
| — | |
| 370,182 | |
| — | |
| — | |
| 370,182 |
Foreign currency translation adjustment |
| | | | | | | — | |
| — | |
| — | |
| (2,504) | |
| — | |
| (2,504) |
Net loss |
| | | | | | | — | |
| — | |
| — | |
| — | |
| (6,140,730) | |
| (6,140,730) |
Balance, December 31, 2023 |
| — | | $ | — | | | 10,378,238 | | $ | 10,378 | | $ | 228,193,977 | | $ | 22,243 | | $ | (225,704,176) | | $ | 2,522,422 |
The accompanying notes are an integral part of these consolidated financial statements.
F-5
Soligenix, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
For the Years Ended December 31, 2023 and 2022
| | | | | | |
|
| 2023 |
| 2022 | ||
Operating activities: |
| |
|
| |
|
Net loss | | $ | (6,140,730) | | $ | (13,798,339) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
|
| |
|
|
Amortization and depreciation | |
| 6,554 | |
| 24,562 |
Non-cash lease expense | |
| 111,153 | |
| 112,714 |
Share-based compensation | |
| 370,182 | |
| 333,389 |
Issuance of common stock to vendors for services | |
| 73,000 | |
| 212,003 |
Issuance of common stock for unexercised purchase option | | | 50,000 | | | — |
Loss on extinguishment of debt | |
| 393,791 | |
| — |
Change in fair value of convertible debt | | | (43,066) | | | — |
Amortization of deferred issuance costs associated with convertible debt | |
| 12,518 | |
| 41,538 |
Change in operating assets and liabilities: | |
| | |
| |
Licensing, contracts and grants receivable | |
| (56,124) | |
| 23,759 |
Prepaid expenses and other current assets | |
| (591,805) | |
| 8,694 |
Research and development incentives receivable | |
| 90,016 | |
| 73,374 |
Operating lease liability | |
| (108,948) | |
| (111,122) |
Accounts payable and accrued expenses | |
| (2,685,073) | |
| 396,651 |
Accrued compensation | |
| (85,577) | |
| 33,756 |
Net cash used in operating activities | |
| (8,604,109) | |
| (12,649,021) |
| | | | | | |
Investing activities: | |
|
| |
|
|
Purchases of office furniture and equipment | |
| — | |
| (13,073) |
Net cash used in investing activities | |
| — | |
| (13,073) |
| | | | | | |
Financing activities: | |
|
| |
|
|
Proceeds from issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | |
| 3,091,462 | |
| 79,354 |
Costs associated with B. Riley At Market Issuance Sales Agreement | |
| (93,011) | |
| (2,533) |
Proceeds from issuance of common stock and pre-funded warrants pursuant to public offering | | | 8,495,817 | | | — |
Stock issuance costs associated with public offering | | | (834,061) | | | — |
Proceeds from the exercise of pre-funded warrants | | | 3,299 | | | — |
Convertible debt repayments | |
| (7,000,000) | |
| — |
Net cash provided by financing activities | |
| 3,663,506 | |
| 76,821 |
Effect of exchange rate on cash and cash equivalents | |
| 27,146 | |
| (99,009) |
Net decrease in cash and cash equivalents | |
| (4,913,457) | |
| (12,684,282) |
Cash and cash equivalents at beginning of year | |
| 13,359,615 | |
| 26,043,897 |
Cash and cash equivalents at end of year | | $ | 8,446,158 | | $ | 13,359,615 |
Supplemental information: | |
|
| |
|
|
Cash paid for state income taxes | | $ | 20,730 | | $ | 16,043 |
Cash paid for interest | | $ | 552,058 | | $ | 857,411 |
Cash paid for lease liabilities: | |
| | |
|
|
Operating lease | | $ | 133,817 | | $ | 133,300 |
Non-cash investing and financing activities: | |
|
| |
|
|
Right-of-use assets and lease liabilities recorded | | $ | — | | $ | 347,546 |
Deferred issuance cost reclassified to additional paid-in capital | | $ | 20,208 | | $ | 60 |
Declaration of Series D preferred stock for stock dividend | | $ | — | | $ | 43 |
Redemption of Series D preferred stock for stock dividend | | $ | 43 | | $ | — |
The accompanying notes are an integral part of these consolidated financial statements.
F-6
Soligenix, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
Note 1. Nature of Business
Basis of Presentation
Soligenix, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company maintains two active business segments: Specialized BioTherapeutics and Vaccines/BioDefense.
Public Health Solutions.
The Company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy (SGX301)(“PDT”) utilizing topical synthetic hypericin activated with safe visible fluorescent light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the Phase 3 FLASH (Fluorescent Light And Synthetic Hypericin) study, regulatory approval is being pursued in the United States (“U.S.”) and Europe. Following submission of a new drug application (“NDA”) for HyBryte™ in the treatment of CTCL in December 2022, the Company received a refusal to file (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”) in February 2023. In April 2023, the Company had a Type A meeting with the FDA to clarify and respond to the issues identified in the RTF letter and to seek additional guidance concerning information that the FDA would require for a resubmitted NDA to be deemed acceptable to file, in order to advance HyBryte™ towards U.S. marketing approval and commercialization. In order to accept an NDA filing for HyBryte™, itsthe FDA is requiring positive results from a second, Phase 3 pivotal study in addition to the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication. Based on this feedback, the Company is collaboratively engaging in active discussions with both the FDA and the European Medicines Agency (“EMA”) in order to define the protocol and evaluate the feasibility of conducting the additional Phase 3 clinical trial evaluating HyBryte™ in the treatment of CTCL in support of potential marketing approval.
Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, the Company’s first-in-class innate defense regulatorInnate Defense Regulator (“IDR”) technology, and dusquetide (SGX942)(SGX942 and SGX945) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and proprietary formulations of oral beclomethasone 17,21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).aphthous ulcers in Behçet’s Disease.
The Company’s Vaccines/BioDefensePublic Health Solutions business segment includes active development programs for RiVax®, its ricin toxin vaccine candidate OrbeShield®, a GI acute radiation syndrome (“GI ARS”) therapeutic candidate and SGX943, aits therapeutic candidate for antibiotic resistant and emerging infectious disease.disease, and vaccine programs, including a program targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of the vaccine program is currently supported byprograms incorporates the use of the Company’s proprietary heat stabilization platform technology, known as ThermoVax®, under existing. To date, this business segment has been supported with government grant and on-going government contract funding. With the government contractfunding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Company will attempt to advance the development of RiVax® to protect against exposure to ricin toxin. The Company has advanced the development of OrbeShield® for the treatment of GI ARS with funds received under its awarded government contracts with the Biomedical Advanced Research and Development Authority (“BARDA”) and NIAID. the Defense Threat Reduction Agency.
The Company will continue to pursue additional government funding support.
The Companyprimarily generates revenues under government grants primarilyand contracts principally from the National Institutes of Health (“NIH”) and government contracts from BARDA and NIAID.. The Company is currently developing RiVax®underwas awarded a NIH contract of up to $24.7 million over six years, and SGX301 and SGX942 under two separate NIH grants ofsubcontract that originally provided for approximately $1.5 million eachfrom a NIAID grant over two years. The NIAID contractyears for the development of OrbeShield®was completed duringCiVax™ and a subcontract that originally provided for approximately $1.1 million from a FDA Orphan Products Development grant over four years for an expanded study of HyBryte™ in the first quartertreatment of 2017, and the base period of the BARDA contract for the development of OrbeShield®expiring, with BARDA electing not to extend the current contract beyond the base period.CTCL. The Company will continue to apply for additional government funding.
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the United States Food and Drug Administration (the U.S. “FDA”)FDA regulations, and other regulatory authorities, litigation, and product liability.
Liquidity
In accordance with Accounting Standards Codification 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. As of December 31, 2017,2023, the Company had an accumulated deficit of $157,270,045.$225,704,176 and working capital of $3,355,212. During
F-7
the year ended December 31, 2017,2023, the Company incurred a net loss of $7,147,083$6,140,730 and used $6,510,567$8,604,109 of cash in operations.operating activities. The Company expects to continue to generate losses in the foreseeable future. The Company’s liquidity needs will be determined largely determined by the budgeted operational expenditures incurred in regards to the progression of its product candidates. Management believes that the Company has sufficient resources available to support its development activities and business operations and timely satisfy its obligations as they become due into the fourth quarter of 2024. The Company does not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to support its operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about the Company’s ability to continue as a going concern through 12 months after the date the financial statements are issued.
To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, the Company plans to meet its liquidity needs primarily include its ability to control the timingsecure additional capital, potentially through a combination of public or private equity offerings and spending on its researchstrategic transactions, including potential alliances and development programs and raisingdrug product collaborations, securing additional funds through potential partnerships and/or financings. Based on the Company’s approved operating budget, current rate of cash outflows, cash on hand, proceeds from government contract and grant programs, securing additional proceeds available from the equity linesale of shares of the common stock via an At Market Issuance Sales Agreement and potentially amending the loan agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), and proceeds fromPontifax to reduce the Stateconversion price in order to allow for conversion of New Jersey Technology Business Tax Certificate Transfer Program, management believesa portion of the debt which will reduce the Company’s debt repayments; however, none of these alternatives are committed at this time. There can be no assurance that its current cashthe Company will be successful in obtaining sufficient funding on terms acceptable to meetit to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the anticipatedcapital that it will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, the Company will not have sufficient cash needs for working capitalresources and capital expendituresliquidity to fund its business operations for at least the next 12 months from issuance offollowing the date the financial statements.statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require the Company to delay, limit, or eliminate the development of business opportunities and its ability to achieve its business objectives and its competitiveness, and its business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce the Company’s ability to access capital, which could negatively affect its liquidity and ability to continue as a going concern. In addition, the perception that the Company may not be able to continue as a going concern may cause others to choose not to deal with it due to concerns about its ability to meet its contractual obligations.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
As of December 31, 2017,2023, the Company had cash and cash equivalents of $7,809,487$8,446,158 as compared to $8,772,567$13,359,615 as of December 31, 2016,2022, representing a decrease of $963,080$4,913,457 or 11%37%. As of December 31, 2017,2023, the Company had working capital of $6,185,863$3,355,212 as compared to a working capital deficit of $7,243,918,($2,663,721) as of December 31, 2022, representing a decreasean increase of $1,058,055$6,018,933 or 15%.The226%. The decrease in cash and working capitalcash equivalents was primarily related to expenditures to supportcash used in operating activities. The increase in working capital is primarily the pivotal Phase 3 clinical trial of SGX301 for the treatment of CTCL and expenditures incurred in preparation and initiationresult of the Phase 3 clinical trialnet proceeds received from financing activities partially offset by the immediate paydown of SGX942 for$5 million of outstanding debt principal balance and any accrued interest resulting from the treatment of oral mucositis in head and neck cancer.
amendment to the convertible debt financing agreement with Pontifax during the year ended December 31, 2023.
Management’s business strategy can be outlined as follows:
| ● |
| ● | Expanding development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients. |
F-8
| ● | Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency (“MHRA”) that a second Phase 3 clinical trial of |
| ● |
| ● | Continue development of |
| ● | ||
| Continue to apply for and secure additional government funding for |
| ● | Pursue business development opportunities for |
| ● | Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development. |
The Company’s plans with respect to its liquidity management include, but are not limited to, the following:
| ● | The Company has up to |
| ● | The Company has continued to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and |
| ● | The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer |
| ● | The Company plans to pursue potential partnerships for |
| ● | The Company | |
| other estimated offering expenses. The Company |
| ● | The Company is currently evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that |
F-9
Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation.
Operating Segments
Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision makingdecision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: Specialized BioTherapeutics and Vaccines/BioDefense.Public Health Solutions.
Cash and Cash Equivalents
The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents.
Contracts and Grants Receivable
In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326) and subsequently related amendments (ASU 2018-19, ASU 2019-04, ASU 2019-05, ASU 2019-10, ASU 2019-11, and ASU 2022-02). This guidance replaces the existing incurred loss impairment guidance and establishes a single allowance framework for financial assets carried at amortized cost based on expected credit losses. The estimate of expected credit losses requires the incorporation of historical information, current conditions, and reasonable and supportable forecasts. The Company adopted this new accounting standard effective January 1, 2023 and all of the related amendments using the retrospective method. The Company determined there was no effect to its opening balance of shareholders’ equity of initially applying the new credit loss standard to its contracts and grants receivable. There was no significant impact to the Company’s operating results for the current period due to this standard update. Management has evaluated the adoption of ASC Topic 326 and concluded the effect of the adoption was immaterial to the financial statements as a whole.
Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from BARDA and NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for doubtful amountscredit losses has been established. If amounts become uncollectible, they are charged to operations.
Intangible Assets
One of the most significant estimates or judgments that the Company makes is whether to capitalize or expense patent and license costs. The Company makes this judgment based on whether the technology has alternative future uses, as defined in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 730,Research and Development. Based on this consideration, the Company capitalizes payments made to legal firms that are engaged in filing and protecting rights to intellectual property and rights for its current products in both the domestic and international markets. The Company believes that patent rights are one of its most valuable assets. Patents and patent applications are a key component of intellectual property, especially in the early stage of product development, as their purchase and maintenance gives the Company access to key product development rights from Soligenix’s academic and industry partners. These rights can also be sold or sub-licensed as part of its strategy to partner its products at each stage of development as the intangible assets have alternative future use. The legal costs incurred for these patents consist of work associated with filing new patents designed to protect, preserve and maintain the Company’s rights, and perhaps extend the lives of the patents. The Company capitalizes such costs and amortizes intangibles on a straight-line basis over their expected useful life – generally a period of 11 to 16 years.
The Company did not capitalize any patent related costs during the years ended December 31, 2017 or 2016.
These intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable or if the underlying program is no longer being pursued. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and carrying value of the related asset or group of assets. No such write downs have occurred during the years ended December 31, 2017 and 2016.
Impairment of Long-Lived Assets
Office furniture and equipment, right of use assets and intangible assetswebsite development costs with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment.
The Company did not record any impairment of long-lived assets for the years ended December 31, 2017 or 2016.2023 and 2022.
Fair Value of Financial Instruments
FASB ASC 820 —Fair Value Measurements and Disclosures,defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available
F-10
to the Company on December 31, 2017.2023 and 2022. Accordingly, the estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments.
FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).
The three levels of the fair value hierarchy are as follows:
| ● | Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. |
| ● | Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. |
| ● | Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. |
In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability.
The carrying amounts reported in the consolidated balance sheetsheets for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments.
The Company recognizes all derivative financial instruments as assets or liabilitiescarrying amount reported in the financial statements and measures them atconsolidated balance sheet as of December 31, 2023 for the convertible debt is its fair value with changes in– see Note 5. The principal amount of the convertible debt was $3,000,000 at December 31, 2023 and the fair value reflected as current period income or loss unlesswas approximately $3,260,934. The fair value of the derivatives qualify as hedges.debt was estimated using the Monte Carlo valuation method, which utilizes certain unobservable inputs. As a result, the fair value estimate represents a Level 3 measurement.
A roll forward of the carrying value of the convertible debt to December 31, 2023 is as follows:
| | | | | | | | | | | | |
| | Balance | | | | | Adjustment to | | Balance | |||
| | December 31, 2022 | | Issued | | fair value | | December 31, 2023 | ||||
Convertible debt at fair value | | $ | — | | $ | 3,304,000 | | $ | (43,066) | | $ | 3,260,934 |
Deferred Issuance Costs
The Company capitalizes certain warrants issuedlegal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in connection withshareholders’ equity as a reduction of additional paid-in capital generated as a result of the Company’s June 2013 registered public offering were accounted for as derivatives. See Note 6,Warrant Liability.issuance.
Revenue Recognition
The Company’s revenues are primarilyinclude revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered
F-11
by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants.
The Company also records revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue.
Research and Development Costs
Research and development costs are charged to expense when incurred in accordance with FASB ASC 730,Research and Development. Research and development includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. Purchased in-process research and development expense represents the value assigned or paid for acquired research and development for which there is no alternative future use as of the date of acquisition.
Accounting for Warrants
The Company considered FASB ASC 815,Evaluating Whether an Instrument is Considered Indexed to an Entity’s Own Stock, which provides guidance for determining whether an equity-linked financial instrument (or embedded feature) issued by an entity is indexed to the entity’s stock and, therefore, qualifying for the first part of the scope exception in paragraph 815-10-15. The Company evaluated the provisions and determined that the warrants issued in connection with the Company’s June 2013 registered public offering contained provisions that protected holders from a decline in the issue price of the Company’s common stock (or “down-round” provisions) and contain net settlement provisions. Consequently, these warrants were recognized as liabilities at their fair value on the date of grant and remeasured at fair value on each reporting date.
During the year ended December 31, 2016, the Company entered into amendments with the holders of those warrants, and as a result the warrants were reclassified to equity as the amended terms of the warrants qualified them to be accounted for as equity instruments. All other warrants that have been issued by the Company were indexed to the Company’s stock and therefore accounted for as equity instruments.
Share-Based Compensation
Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board.
From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed. Typically these instruments vest upon issuanceperformed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and therefore the entire share-based compensation expense is recognized upon issuanceunrestricted stock to the vendors and/or consultants.
Share-based compensation expense for options, warrantsCompany’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock granted to non-employees has been determined in accordance with and FASB ASC 505-50,Equity-Based Payments to Non-Employees, and representsare not covered by a reoffer prospectus, the fair valuecertificates reflecting such shares reflect a Securities Act of the consideration received, or the fair value of the equity instruments issued, whichever may be more reliably measured. For options that vest over future periods, the fair value of options granted1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is amortized asmeasured on the options vest. The fair valuedate of grant and is remeasured each reporting period until performance is complete.recognized when the services are performed.
For the year ended December 31, 2017, the Company issued 476,100 stock options at a weighted average exercise price of $2.24 per share. The fair value of options issued during the years ended December 31, 20172023 and 20162022 was estimated using the Black-Scholes option-pricing model and the following assumptions:
| ● | a dividend yield of 0%; |
| ● | an expected life of |
F-12
| ● | volatility of |
| ● |
| risk-free interest rates ranging from |
The fair value of each option grant made during 20172023 and 20162022 was estimated on the date of each grant using the Black-Scholes option pricing model and amortizedrecognized as share-based compensation expense ratably over the option vesting periods, which approximates the service period. The expected term of options granted is derived using company history of options exercised. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The Company accounts for forfeitures as they are incurred.
Foreign Currency Transactions and Translation
In 2018, the Company changed the status of a wholly-owned subsidiary in the UK from inactive to active and incurred expenditures in multiple currencies including the U.S. dollar, the British Pound and the Euro to fund its clinical trial operations in the UK and select countries in Europe. In accordance with FASB ASC 830 Foreign Currency Matters, the UK subsidiary expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as a cumulative translation adjustment (“CTA”), which is a component of accumulated other comprehensive loss. In 2023 and 2022, the Company recognized a foreign currency transaction gain of $1,483 and a foreign currency transaction loss of ($30,549), respectively, in the accompanying consolidated statements of operations.
Income Taxes
Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. No current or deferredThe Company sold 2022, 2021 and 2020 New Jersey NOL carryforwards resulting in the recognition of income taxes have been provided throughtax benefits, net of transaction costs of $1,767,803 and $1,154,935 during the years ended December 31, 2017 due to2023 and 2022, respectively. The Company sold its 2022 New Jersey NOLs and has recorded a receivable of $606,606 which is included in prepaid expenses and other current assets on the net operating losses incurred byaccompanying consolidated balance sheet for the Company since its inception.year ended December 31, 2023. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for 20172023 and 2016.2022. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 20172023 or 2022.
Research and 2016.Development Incentive Income and Receivable
The Company recognizes other income from UK research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The small or medium sized enterprise (“SME”) research and development tax relief program supports companies that seek to research and develop an advance in their field and is governed through legislative law by HM Revenue & Customs as long as specific eligibility criteria are met.
EarningsManagement has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the SME research and development tax relief program described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time. As the tax incentives may be received without regard to an entity’s actual tax liability, they are not subject to accounting for income taxes. As a result, amounts realized under the SME research and development tax relief program are recorded as a component of other income.
F-13
The research and development incentive receivable represents an amount due in connection with the above-described tax relief program. The Company has recorded a research and development incentive receivable of approximately $49,000 and $128,000 as of December 31, 2023 and 2022, respectively in the consolidated balance sheets.
The following table shows the change in the UK research and development incentives receivable from December 31, 2022 to December 31, 2023:
| | | | | | | | | |
|
| Current |
| Long-Term |
| Total | |||
Balance at December 31, 2022 |
| $ | 104,198 | | $ | 24,114 | | $ | 128,312 |
UK research and development incentives, transfer |
| | 24,114 | | | (24,114) | |
| — |
UK research and development incentives | | | — | | | 24,897 | | | 24,897 |
Adjustments to 2021 and 2022 incentives earned | | | (1,113) | | | — | | | (1,113) |
UK research and development incentives cash receipt |
| | (104,422) | |
| — | |
| (104,422) |
Foreign currency translation |
| | 1,117 | |
| 571 | |
| 1,688 |
Balance at December 31, 2023 | | $ | 23,894 | | $ | 25,468 | | $ | 49,362 |
Loss Per Share
Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income (loss) availableloss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Included within the Company’s weighted average common shares outstanding for the year ended December 31, 2023, are common shares issuable upon the exercise of the pre-funded warrants associated with the May 2023 public offering, as these pre-funded warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented.
| For the Year Ended | For the Year Ended | |||||||
| December 31, 2017 | December 31, 2016 | |||||||
| Numerator: | ||||||||
| Net loss for basic earnings per share | $ | (7,147,083 | ) | $ | (3,245,383 | ) | ||
| Less change in fair value of warrant liability | - | 1,541,241 | ||||||
| Net loss for diluted earnings per share | $ | (7,147,083 | ) | $ | (4,786,624 | ) | ||
| Denominator: | ||||||||
| Weighted-average basic common shares outstanding | 6,144,237 | 3,481,460 | ||||||
| Assumed conversion of dilutive securities: | ||||||||
| Common stock purchase warrants | - | 102,127 | ||||||
| Denominator for diluted earnings per share – adjusted weighted-average shares | 6,144,237 | 3,583,387 | ||||||
| Basic net loss per share | ($ | 1.16 | ) | ($ | 0.93 | ) | ||
| Diluted net loss per share | ($ | 1.16 | ) | ($ | 1.34 | ) | ||
The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive.anti-dilutive due to the losses in each period:
| For the Year Ended | For the Year Ended | |||||||||||
| December 31, 2017 | December 31, 2016 | |||||||||||
| | | | | ||||||||
| | December 31, | | December 31, | ||||||||
|
| 2023 |
| 2022 | ||||||||
| Common stock purchase warrants | 2,577,238 | 2,853,575 | | 6,538,073 | | 667 | ||||||
| Stock options | 785,655 | 330,605 |
| 906,892 |
| 192,273 | ||||||
Convertible debt |
| 2,114,403 |
| 162,602 | ||||||||
| Total | 3,362,893 | 3,184,180 |
| 9,559,368 |
| 355,542 | ||||||
The weighted average exercise price of the Company’s stock options and warrants outstanding at December 31, 2017 were $7.15 and $4.38 per share, respectively.
Use of Estimates and Assumptions
The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of warrants and stock options and the useful life of intangiblesto accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates.
Recently Issued Accounting PronouncementsNote 3. Leases
In February 2016, the FASB issued ASU No. 2016-02, “Leases” (topic 842). The FASB issued this update to increase transparencyCompany classifies a lease for its office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey as an operating lease, and comparability among organizations by recognizingrecorded a related right-of-use lease assetsasset and lease liability accordingly. Pursuant to an amendment executed on June 21, 2022, the lease has been extended to October 2025. The current rent of $11,367 per month will be maintained until November 2024 when it will be increased to $11,625 where it will remain until expiration. As of December 31, 2023 and 2022, the Company’s consolidated balance sheets included a right-of-use lease asset of $229,834 and $340,987 for the office space, respectively. The Company’s consolidated balance sheets as of December 31, 2023 and 2022 included corresponding lease liabilities onof $233,627 and $342,575 for the balance sheetoffice space, respectively.
F-14
The following represents a reconciliation of contractual lease cash flows to the right-of-use lease asset and disclosing key information about leasing arrangements. The updated guidance is effective for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption of the update is permitted. The Company is evaluating the impact of the adoption of this update on its consolidated financial statements and related disclosures.
In March 2016, the FASB issued ASU No. 2016-09, “Improvements to Employee Share-Based Payment Accounting, which amends ASC Topic 718, and intends to simplify various aspects related to how share-based payments are accounted for and presentedliability recognized in the financial statements. It is effective for annual reporting periods beginning after December 15, 2016, and interim periods within that reporting period. The Company adopted this standard effective January 1, 2017, and elected not to change its accounting policy with respect to the estimation of forfeitures. As a result, there was no material impact to the financial statements.statements:
| | | | |
| | Operating | | |
|
| Lease |
| |
Contractual cash payments for the remaining lease term as of December 31, 2023 | | | | |
2024 |
| $ | 136,917 | |
2025 | | | 116,250 | |
Less implied interest | | | 19,540 | |
Total | | $ | 233,627 | |
Discount rate applied | |
| 8.47 | % |
Remaining lease term (months) as of December 31, 2023 | |
| 22 | |
| | | | |
Right-of-use lease asset: | |
|
| |
Right-of-use lease asset, January 1, 2022 | | $ | 106,155 | |
New lease extension June 21, 2022 | | | 347,546 | |
Less: reduction/amortization | |
| 112,714 | |
Right-of-use lease asset, December 31, 2022 | | | 340,987 | |
Less: reduction/amortization | | | 111,153 | |
Right-of-use lease asset, December 31, 2023 | | $ | 229,834 | |
| | | | |
Lease liability: | |
|
| |
Lease liability, January 1, 2022 | | $ | 106,151 | |
New lease extension June 21, 2022 | | | 347,546 | |
Less: repayments | |
| 111,122 | |
Lease liability, December 31, 2022 | |
| 342,575 | |
Less: repayments | |
| 108,948 | |
Lease liability, December 31, 2023 | | $ | 233,627 | |
| | | | |
Lease expense for the year ended December 31, 2022: | |
|
| |
Lease expense | | $ | 134,892 | |
Total | | $ | 134,892 | |
| | | | |
Lease expense for the year ended December 31, 2023: | | | | |
Lease expense | | $ | 136,022 | |
Total | | $ | 136,022 | |
| | | | |
In July 2017, the FASB issued ASU No. 2017-11,(Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. The new standard applies to issuers of financial instruments with down-round features. A down-round provision is a term in an equity-linked financial instrument (i.e. a freestanding warrant contract or an equity conversion feature embedded within a host debt or equity contract) that triggers a downward adjustment to the instrument’s strike price (or conversion price) if equity shares are issued at a lower price (or equity-linked financial instruments are issued at a lower strike price) than the instrument’s then-current strike price. The purpose of the feature is typically to protect the instrument’s counterparty from future issuances of equity shares at a more favorable price. The ASU amends (1) the classification of such instruments as liabilities or equity by revising the certain guidance relative to evaluating if they must be accounted for as derivative instruments and (2) the guidance on recognition and measurement of freestanding equity-classified instruments. For the Company, this ASU is effective January 1, 2019, with early adoption permitted. The Company is evaluating the impact of the adoption of this update on its consolidated financial statements and related disclosures.
Note 3. Intangible Assets
The following is a summary of intangible assets which consists of licenses and patents:
Cost | Accumulated Amortization | Net Book Value | ||||||||||
| December 31, 2017 | ||||||||||||
| Licenses | $ | 462,234 | $ | 388,282 | $ | 73,952 | ||||||
| Patents | 1,893,185 | 1,893,185 | - | |||||||||
| Total | $ | 2,355,419 | $ | 2,281,467 | $ | 73,952 | ||||||
| December 31, 2016 | ||||||||||||
| Licenses | $ | 462,234 | $ | 361,044 | $ | 101,190 | ||||||
| Patents | 1,893,185 | 1,867,747 | 25,438 | |||||||||
| Total | $ | 2,355,419 | $ | 2,228,791 | $ | 126,628 | ||||||
Amortization expense was $52,676 and $62,104 in 2017 and 2016, respectively.
Based on the balance of licenses and patents at December 31, 2017, future annual amortization expense is expected to be as follows:
| Year | Amortization Expense | |||
| 2018 | $ | 37,300 | ||
| 2019 | $ | 36,652 | ||
License fees and royalty payments are expensed annually as incurred, as the Company does not attribute any future benefits of such payments.
Note 4.Accrued Expenses
The following is a summary of the Company’s accrued expenses:
| For the Years Ended December 31, | ||||||||||||||
| 2017 | 2016 | |||||||||||||
| | | | | | | ||||||||
| | December 31, | ||||||||||||
|
| 2023 |
| 2022 | ||||||||||
| Clinical trial expenses | $ | 1,011,666 | $ | 741,174 | | $ | 1,993,784 | | $ | 1,884,117 | ||||
| Other | 131,640 | 64,944 | |
| 424,218 | |
| 423,629 | ||||||
| Total | $ | 1,143,306 | $ | 806,118 | | $ | 2,418,002 | | $ | 2,307,746 | ||||
Note 5. Notes PayableDebt
On July 29, 2015,In December 2020, the Company entered into equity purchase agreements (the “Equity Line Purchase Agreements”a $20 million convertible debt financing agreement with Pontifax Medison Debt Financing (“Pontifax”), the healthcare-dedicated venture and registration rights agreementsdebt fund of the Pontifax life science funds. Under the terms of the agreement with certain accredited institutional investors. In consideration for entering into the Equity Line Purchase Agreements,Pontifax, the Company issuedhad access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and had an interest-only period for the first two years with a fixed interest rate of 8.47% on borrowed amounts and an interest rate of 1% on amounts available but not borrowed as an unused line of credit fee. After the interest-only period, the outstanding principal is to be repaid in quarterly payments of $1 million each
F-15
commencing in the first quarter of 2023. The agreement is secured by a lien covering substantially all of the Company’s assets, other than intellectual property.
Upon the closing of this transaction, the Company accessed the first tranche of $10 million, had the option to draw the second tranche of $5 million at any time during the initial 12 months of the loan and the third tranche of $5 million upon filing of the HyBryte™ NDA, subject to certain conditions. The Company elected to let the options to borrow both the second and third tranches expire as of December 15, 2021 and March 15, 2022, respectively.
On April 19, 2023, the Company entered into an amendment to the investors promissory notes havingconvertible debt financing agreement dated December 15, 2020 with Pontifax. The amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an aggregateoutstanding principal balance of $3 million. The amendment also provided for a new interest only period from the date of the amendment through June 30, 2024, reduced quarterly principal repayments from $1 million to $750,000 and eliminated the minimum cash covenant. Further, the amendment reduced the conversion price with respect to the remaining principal amount of $300,000, which were recorded as stock issuance costs. The promissory notes had an issuance date present value of $282,071 and were repaid on April 15, 2016. The promissory notes did not include terms for interest, thereforeunder the interest was imputed at 9%. Total discount amortization of $7,281 was recorded as interest expense for the year ended December 31, 2016. The discount was accreted over the termagreement to (i) 90% of the promissory notes using the effective interest rate method.
Note 6. Warrant Liability
On June 25, 2013, the Company consummated a public offering in which the Company issued shares of common stock, together with warrants to purchase shares of common stock. These warrants contained provisions that protected holders from a decline in the issueclosing price of the Company’s common stock (or “down-round” provision) and contained net settlement provisions. As a result,on the Company accounted for these warrants as liabilities instead of equity instruments. Down-round provisions reduceday before the exercise or conversion price of a warrant if the Company issues equity shares for a price that is lower than the exercise or conversion pricedelivery of the warrants. Net settlement provisions allow the holder of the warrant to surrender shares underlying the warrant equalconversion notice with respect to the exercise price as payment of its exercise price, instead of exercising the warrant by paying cash. The Company evaluates whether warrants to acquire its common stock contain provisions that protect holders from declines in the stock price or otherwise could result in modification of the exercise price and/or the number offirst 588,599 shares to be issued under the respective warrant agreements based on a variable that is not an input to the fair value of a “fixed for fixed” option. As a result of the Company’s December 2014 registered public unit offering, the exercise price of warrants outstanding in connection with the public offering completed in June 2013 was adjusted to $6.10 per share. As a result of the Company’s December 2015 drawings on the Equity Line Purchase Agreements, the exercise price of warrants outstanding in connection with the public offering conducted in June 2013 was adjusted to $5.10 per share. The Company recognized these warrants as liabilities at their fair value on the date of grant and remeasured them to fair value on each reporting date.
The Company recognized an initial warrant liability for the warrants issued in connection with the registered public offering completed in June 2013 totaling $4,827,788, which was based on the June 25, 2013 closing price of a share of the Company’s common stock as reported on OTC Marketsissuable upon conversion and to (ii) $1.70 with respect to all shares of $9.60. During November 2016,the Company’s common stock issuable upon conversion in excess of the first 588,599 shares so issued. The remaining terms of the agreement remain in effect without modification.
The amendment to the convertible debt financing agreement with Pontifax resulted in the extinguishment of the original convertible debt for accounting purposes. The Company concluded that the amended debt instrument has an embedded derivative that requires bifurcation pursuant to ASC 815-15-25-1 and qualifies for the fair value option in accordance with ASC 815-15-25-4 through ASC 815-15-25-6. The Company elected to account for the amended convertible debt using the fair value option, which requires the Company entered into amendments with the holdersto record changes in fair value as a component of those warrants pursuant to which the Company agreed to reduce the exercise price (after giving effect to the one-for-ten reverse stock split effective October 7, 2016) from $5.10 per share to $0.80 per share and permit those warrants to be exercised on a “cashless exercise” basis, and the Company eliminated the “down round” provision of those warrants not immediately exercised. As a resultother income or expense. The fair value of the amendments, the warrant liability was remeasured as ofconvertible debt on the date of the modification,amendment was approximately $3,304,000, which resulted in an approximate $1,541,000 decrease in the carrying valuerecognition of a loss on extinguishment of approximately $394,000 on the warrant liability, which was recognized in the statementCompany’s accompanying consolidated statements of operations for the year ended December 31, 2016.2023. The warrant liability relatedfair value of the convertible debt as of December 31, 2023 was approximately $3,260,934, which resulted in the recognition of $43,066 of other income from the change in the fair value of the convertible debt on the Company’s accompanying consolidated statements of operations for the year ended December 31, 2023. The fair value of the convertible debt was estimated using the Monte Carlo valuation method.
| | | | | | | | | |
Assumptions | | 4/19/2023 | | 9/30/2023 | | 12/31/2023 | |||
Stock price | | $ | 1.72 | | $ | 0.56 | | $ | 0.76 |
Volatility | | | 75.20% | | | 110.50% | | | 141.90% |
Discount rate | | | 16.28% | | | 14.84% | | | 13.62% |
Risk-free rate | | | 4.27% | | | 5.24% | | | 4.65% |
Interest expense incurred during the years ended December 31, 2023 and 2022 was $402,615 and $847,000, respectively. Interest expense paid during the years ended December 31, 2023 and 2022 was $552,058 and $857,411, respectively.
Pontifax may elect to convert the outstanding loan drawn into shares of the Company’s common stock at any time prior to repayment. There was $3,000,000 of principal and $63,351 of accrued interest outstanding as of December 31, 2023.The Convertible Notes were convertible at (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the warrants not immediately exercised was then reclassifiedfirst 588,599 shares issuable upon conversion as of December 31, 2023 and (ii) $1.70 with respect to equity as the amended termsall shares issuable upon conversion in excess of the warrants qualified themfirst 588,599 shares issued upon conversion as of December 31, 2023. The Company also has the ability to be accounted for as equity instruments. Offorce the 303,694conversion of the loan into shares of the Company’s common stock that remained issuable uponat the exercise of such warrants as ofsame conversion price, subject to certain conditions.
Annual principal and interest payments due, according to the amendment date, warrants to purchase a total of 42,444 shares were exercised on a cashless basis and as a result 33,978 shares of common stock were issued on November 9, 2016.
The assumptions used in the valuation of the warrants issued in the June 25, 2013 financing on November 9, 2016 using the Black Scholes model wereagreement’s contractual terms, assuming no conversion is as follows:
| November 9, 2016 | ||||
| Number of shares underlying the warrants | 303,694 | |||
| Exercise price | $ | 0.80 | ||
| Volatility | 93 | % | ||
| Risk-free interest rate | 0.81 | % | ||
| Expected dividend yield | 0 | % | ||
| Expected warrant life (years) | 1.63 | |||
| Stock price | $ | 3.65 | ||
| | | | | | | | | |
Year |
| Principal |
| Interest |
| Total | |||
2024 | | $ | 2,250,000 | | $ | 270,808 | | $ | 2,520,808 |
2025 | |
| 750,000 | |
| 16,012 | |
| 766,012 |
Total | | $ | 3,000,000 | | $ | 286,820 | | $ | 3,286,820 |
Recurring Level 3 Activity and ReconciliationF-16
The table below provides a reconciliationTable of the beginning and ending balances for the liability measured at fair value using significant unobservable inputs (Level 3).Contents
Fair Value Measurements Using Significant Unobservable Inputs (Level 3):
| December 31, 2015 | Reclassification of warrant liability to equity in 2016 | Decrease in Fair Value | December 31, 2016 | |||||||||||||
| Warrant liability | $ | 2,434,101 | $ | (892,860 | ) | $ | (1,541,241 | ) | $ | 0 | ||||||
Note 7.6. Income Taxes
The income tax benefit consisted of the following for the years ended December 31, 20172023 and December 31, 2016:2022:
| 2017 | 2016 | |||||||||||||
| | | | | | | ||||||||
|
| 2023 |
| 2022 | ||||||||||
| Federal | $ | - | $ | - | | $ | — | | $ | — | ||||
| State | (416,810 | ) | (530,143 | ) | ||||||||||
Foreign | |
| — | |
| — | ||||||||
State & Local | |
| (1,767,803) | |
| (1,154,935) | ||||||||
| Income tax benefit | $ | (416,810 | ) | $ | (530,143 | ) | | $ | (1,767,803) | | $ | (1,154,935) | ||
The significant components of the Company’s deferred tax assets and liabilities at December 31, 20172023 and 20162022 are as follows:
| 2017 | 2016 | |||||||||||||
| | | | | | | ||||||||
|
| 2023 |
| 2022 | ||||||||||
| Net operating loss carry forwards | $ | 21,286,000 | $ | 32,028,000 | | $ | 27,522,000 | | $ | 27,252,000 | ||||
| Orphan drug and research and development credit carry forwards | 7,878,000 | 6,374,000 | |
| 8,921,000 | |
| 8,837,000 | ||||||
| Equity based compensation | 1,332,000 | 1,943,000 | |
| 246,000 | |
| 285,000 | ||||||
| Intangibles | 1,289,000 | 1,921,000 | |
| 1,409,000 | |
| 1,696,000 | ||||||
Capitalized research and development (Section 174) | |
| 2,311,000 | |
| 1,832,000 | ||||||||
Lease liability | |
| 66,000 | |
| 96,000 | ||||||||
Other | | | (12,000) | | | — | ||||||||
| Total | 31,785,000 | 42,266,000 | |
| 40,463,000 | |
| 39,998,000 | ||||||
| Valuation allowance | (31,785,000 | ) | (42,266,000 | ) | | | (40,398,000) | | | (39,902,000) | ||||
| Net deferred tax assets | $ | - | $ | - | | | 65,000 | | | 96,000 | ||||
Right of use asset | | | (65,000) | | | (96,000) | ||||||||
Total gross deferred tax liabilities | |
| (65,000) | |
| (96,000) | ||||||||
Net deferred tax assets | | $ | — | | $ | — | ||||||||
The Company had gross NOLs at December 31, 20172023 of approximately $99,402,000$123.0 million for federal tax purposes, approximately $12.9 million for state tax purposes and approximately $5,766,000 of New Jersey NOL$3.7 million for foreign tax purposes. Federal losses generated in 2018 or later will carry forwards remaining after the sale of unused net operating loss carry forwards, portions of which will begin to expire in 2018.forward indefinitely. In addition, the Company has $8,000,000approximately $8.9 million of various tax credits which expire from 2018 to 2035. Thecredit the Company may be able to utilize its NOLs to reduce future federal and state income tax liabilities. However, these NOLs are subject to various limitations under Internal Revenue Code (“IRC”) Section 382. IRC Section 382 limits the use of NOLs to the extent there has been an ownership change of more than 50 percentage points. In addition, the NOL carry forwardscarryforwards are subject to examination by the taxing authority and could be adjusted or disallowed due to such exams. Although the Company has not undergone an IRC Section 382 analysis, it is likely that the utilization of the NOLs may be substantially limited.
The Company and one or more of its subsidiaries files income tax returns in the U.S. Federalfederal jurisdiction, and various state and local jurisdictions. During the years ended December 31, 20172023 and 2016,2022 in accordance with the State of New Jersey’s Technology Business Tax Certificate Program, which allowed certain high technology and biotechnology companies to sell unused NOL carry forwardscarryforwards to other New Jersey-based corporate taxpayers, the Company sold New Jersey NOL carry forwards, resulting in the recognition of $416,810$1,767,803 and $530,143$1,154,935, respectively, of income tax benefit, net of transaction costs, respectively.costs. The Company sold its 2022 New Jersey NOLs and has recorded a receivable of $606,606 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2023. There can be no assurance as to the continuation or magnitude of this program in the future.
The Tax Cuts and Jobs Act of 2017 (“TCJA”) has modified the IRC 174 expenses related to research and development for the tax years beginning after December 31, 2021. Under the TCJA, the Company must now capitalize the expenditures related to research and development activities and amortize over five years for U.S. activities and 15 years for non-U.S. activities using a mid-year convention. Therefore, the capitalization of research and development costs in accordance with IRC 174 resulted in a deferred tax asset of $2,310,677. |
F-17
Reconciliations of the difference between income tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended December 31, 20172023 and 20162022 were as follows:
| 2017 | 2016 | ||||||||||||
| | | | | | ||||||||
|
| 2023 |
| 2022 |
| ||||||||
| Federal tax at statutory rate | (34.0 | )% | (34.0 | )% |
| (21.0) | % | (21.0) | % | ||||
| State tax benefits, plus sale of NJ NOL, net of federal benefit | (11.6 | ) | (7.9 | ) |
| (21.6) |
| (2.4) | | ||||
Foreign tax rate difference |
| 0.1 |
| 0.2 | | ||||||||
Orphan drug and research and development credits |
| (2.0) |
| (3.9) | | ||||||||
| Permanent differences | 5.7 | 10.3 |
| 0.9 |
| 3.1 | | ||||||
| Orphan drug and research and development credits | (13.9 | ) | (38.8 | ) | |||||||||
| Change in statutory rate | 186.9 | - | |||||||||||
Foreign NOL adjustments |
| 0.7 |
| 0.4 | | ||||||||
Expiration of tax attributes |
| 14.2 |
| 9.1 | | ||||||||
| Change in valuation allowance | (138.6 | ) | 56.4 |
| 6.3 |
| 6.8 | | |||||
| Income tax benefit | (5.5 | )% | (14.0 | )% |
| (22.4) | % | (7.7) | % | ||||
On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referredEntities are also required to as the Tax Cutsevaluate, measure, recognize and Jobs Act (the "Tax Act"). The Tax Act significantly revises U.S. corporate income taxation by, among other things, lowering the U.S. corporatedisclose any uncertain income tax rate from 35.0 % to 21.0% effective January 1, 2018.provisions taken on their income tax returns. The Company does not anticipate any impact tohas analyzed its tax expense due to the full valuation allowance on its deferred tax assetspositions and believeshas concluded that the most significant impact on its consolidated financial statements will be reductionas of approximately $14 million for the deferred tax assets related toDecember 31, 2023, there were no uncertain positions. The Company’s U.S. federal and state net operating losses have occurred since its inception and other assets. Such reduction is fully offset by changesas such, tax years subject to potential tax examination could apply from 2011, the Company’s valuation allowance.
In December 2017,earliest year with a net operating loss carryover, because the Securities and Exchange Commission issued Staff Accounting Bulletin 118, which allows a measurement period, not to exceed oneutilization of net operating losses from prior years opens the relevant year to finalizeaudit by the accounting forIRS and/or state taxing authorities. Interest and penalties, if any, as they relate to income taxes assessed, are included in the income tax impacts of the Tax Act. Until the accountingprovision. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for the income tax impacts of the Tax Act is complete, the reported amounts are based on reasonable estimates, are disclosed as provisionalyears ended December 31, 2023 and reflect any adjustments in subsequent periods as they refine their estimates or complete their accounting of such tax effects.2022.
Note 8.7. Shareholders’ Equity (Deficit)
Preferred Stock
The Company has 350,000 shares of preferred stock authorized, none of which are50,000 were designated as Series D preferred stock during the year ended December 31, 2023.
Series D Preferred Stock
On December 21, 2022, the Board of Directors of the Company declared a dividend for the stockholders of record on January 3, 2023. The dividend consists of one one-thousandth of a share of Series D preferred stock, par value $0.001 per share, for each outstanding share of the Company's common stock. The Series D preferred stock has the following rights and restrictions:
General; Transferability - Series D preferred stock shares will be in book-entry form without certificates. Transfers can only happen alongside common stock transfers, with 1/1,000th of a Series D preferred stock share transferred for each common stock share transferred.
Voting Rights - Each Series D preferred stock share gives the holder 1,000,000 votes. If a shareholder owns a fraction of a share, they will have a proportional number of votes.
Series D preferred stock and common stock shares only vote together on two specific matters:
| 1. | Any plan to change the Company's Certificate of Incorporation for a reverse stock split. |
| 2. | Any plan to delay a stockholders' meeting to vote on a reverse stock split (the "Adjournment Proposal"). |
When voting on the reverse stock split or the Adjournment Proposal, each Series D preferred stock share (or fraction of a share) will vote the same way as the common stock share it was issued from.
Dividend Rights - The holders of Series D preferred stock will not be entitled to receive dividends of any kind.
Liquidation Preference - If the Company undergoes liquidation, dissolution, or outstanding.winding up, Series D preferred stock has priority over common stock for asset distribution. In such a situation, Series D preferred stockholders will receive a cash payment of $0.001 per share before any distribution is made to common stockholders.
F-18
Redemption - If Series D preferred stockholders do not attend or vote by proxy at a meeting for the reverse stock split and Adjournment Proposal, their shares will be automatically redeemed by the Company. If any Series D preferred stock remains after this redemption, it can be redeemed in one of two ways:
| 1. | The Board decides to redeem the shares at a time and date of their choosing. |
| 2. | The shares will be automatically redeemed when the Company's stockholders approve the reverse stock split during a meeting for this purpose. |
When Series D preferred stock is redeemed, stockholders receive a cash payment based on the number of shares they own. For every 100 whole shares redeemed, the stockholder will get $0.10 in cash.
The Series D preferred stock shares were classified as mezzanine equity as of December 31, 2022 since they were not mandatorily redeemable but were redeemable based on an event not entirely controlled by the Company. All Series D preferred stock were redeemed in conjunction with the special meeting of the shareholders’ on February 8, 2023.
Common Stock
The following items represent transactions in the Company’s common stock for the year ended December 31, 2017:
2023:
| ● |
| ● |
| ● |
| ● | The Company sold 2,301,500 shares of common stock and 4,237,000 pre-funded warrants pursuant to the May 2023 public offering for $1.30 per share on May 9, 2023. |
| ● | The Company issued 2,023,000 shares of common stock pursuant to the |
| ● |
| ● |
| ● | The Company issued 400,000 shares of common stock |
| ● | The Company issued 536,384 shares of common stock pursuant to the cashless exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.001 on September 6, 2023. |
The following items represent transactions in the Company’s common stock for the year ended December 31, 2016:
2022:
| ● | The Company issued |
| ● | The Company issued a vendor 6,411 shares of fully vested common stock with a fair value of $7.80 per share on May 6, 2022. |
F-19
| ● | The Company issued a vendor 3,664 shares of fully vested common stock with a fair value of $13.65 per share on August 5, 2022. |
| ● | The Company issued a vendor 1,667 shares of fully vested common stock with a fair value of $7.20 per share on October 4, 2022. |
| ● | The Company issued a vendor 5,129 shares of fully vested common stock with a fair value of $9.75 per share on November 7, 2022. |
| ● | The Company issued 8,542 shares of common stock pursuant to the |
Equity Line
In November 2013, the Company entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). The Lincoln Park equity facility allowed the Company to require Lincoln Park to purchase up to $10.6 million of our common stock over a 36-month period depending on certain conditions. During the year ended December 31, 2016, there were no sales of common stock under the Lincoln Park 2013 equity facility. The 2013 Lincoln Park equity facility expired in November 2016 in accordance with the terms of the agreement.
In March 2016, the Company entered into a common stock purchase agreement with Lincoln Park. The 2016 Lincoln Park equity facility allows the Company to require Lincoln Park to purchase up to 10,000 shares (“Regular Purchase”)All issuances of the Company’s common stock every two business days, up to an aggregate of $12.0 million over approximately a 36-month period with such amounts increasing as the quoted stock price increases. The Regular Purchase may be increased up to 15,000 shares of common stock if the closing price of the common shares is not below $10.00, up to 20,000 shares of common stock if the closing price of the common shares is not below $15.00 and up to 25,000 shares of common stock if the closing price of the common shares is not below $20.00. The purchase price for the Regular Purchase shall be equalyears ended December 31, 2023 and 2022 described above, other than shares issued to vendors or issued pursuant to the lesserexclusive option agreement, were registered on a Registration Statement on Form S-8 (SEC File No. 333-208515), a Registration Statement on Form S-1 (333-271049) and a Registration Statement on Form S-3 (SEC File No. 333-239928). The certificates evidencing unregistered shares reflect a Securities Act of (i) the lowest sale price of the common shares during the purchase date, or (ii) the average of the three lowest closing sale prices of the common shares during the twelve business days prior to the purchase date. Each Regular Purchase shall not exceed $750,000. Furthermore, for each purchase by Lincoln Park, additional commitment shares in commensurate amounts up to a total of 50,000 shares will be issued based upon the relative proportion of the aggregate amount of $12.0 million. In addition to the Regular Purchase and provided that the closing price of the common shares is not below $7.50 on the purchase date, the Company in its sole discretion may direct Lincoln Park on each purchase date to purchase on the next stock trading day (Accelerated Purchase Date”) additional shares of Company stock up to the lesser of (i) three times the number of shares purchased following a Regular Purchase or (ii) 30% of the trading volume of shares traded on the Accelerated Purchase Date at a price equal to the lesser of the closing sale price on the Accelerated Purchase Date or 95% of the Accelerated Purchase Date’s volume weighted average price. As of December 31, 2017, the Company had $10.2 million available under the equity facility.1933, as amended, restrictive legend.
Upon entering into the agreement, the Company issued 10,000 shares of common stock as consideration for its commitment to purchase sharesThe issuances of the Company’s common stock to vendors and pursuant to the exclusive option agreement as described above were exempt under Section 4(a)(2) of the purchase agreement.Securities Act of 1933, as amended. The valuerecipients are knowledgeable, sophisticated and experienced in making investment decisions of these shares on the date granted was $81,000, which was accounted for as a stock issuance cost.
During the year ended December 31, 2016,this kind and received adequate information about the Company sold 260,000 shares of common stock and issued 7,135 commitment shares and received proceeds of $1,712,320.or had adequate access to information about the Company. The value of commitment shares on the date granted was $47,244 which was accounted for as a stock issuance cost.
During the year ended December 31, 2017,vendors represented to the Company sold 50,000 sharesthat the vendors are not “consultants” for purposes of common stock and issued 483 commitment shares and received proceeds of $115,930. The value of commitment shares on the date granted was $1,125, which was accounted for as a stock issuance cost.Nasdaq Listing Rule 5635(c).
FBRB. Riley At Market Issuance Sales Agreement and Common Stock Offerings
On August 11, 2017, the Company entered into an At Market Issuancethe B. Riley Sales Agreement with FBR Capital Markets & Co. (“FBR”) to sell shares of the Company’s common stock with aggregate gross proceeds of up to $4,800,000, from time to time, through an “at-the-market” equity offering program under which FBRB. Riley acts as sales agent. Under the B. Riley Sales Agreement, the Company set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales weremay be requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The B. Riley Sales Agreement provided that FBRB. Riley was entitled to compensation for its services in an amount equal to 3% of the gross proceeds from the sale of shares sold under the SalesB. Riley Sale Agreement. The offering costs incurred to register the shares pursuant to theB. Riley Sales Agreement were $164,825. The Company had no obligation to sell any shares under the Sales Agreement, and could suspend solicitation and offers under the Sales Agreement. The shares were issued pursuant to the Company’s shelf registration statement on Form S-3 and the Prospectus Supplement filed August 11, 2017 with the U.S. Securities and Exchange Commission in connection with the offer and sale of the shares pursuant to the Sales Agreement. There are no more shares that can be sold under the Prospectus Supplement filed on August 11, 2017 as a result of the Company’s registered direct offering and private placement on November 3, 2017 (see below).has expired.
On November 3, 2017, the Company issued 1,575,500 shares of common stock at a purchase price of $2.00 per share in a registered direct offering and 982,000 shares of common stock at a purchase price of $2.00 per share in a concurrent private placement. In connection with the concurrent registered public offering and the private placement, warrants to purchase 51,151 shares of the Company’s common stock were issued to representatives of the underwriters of the offering. The warrants are exercisable at $2.50 per share of common stock underlying the warrants for a four-year period commencing six months from the effective date of the offering. Gross proceeds to the Company from these offerings were approximately $5,115,000 before deducting placement agent fees and other estimated offering expenses payable by the Company. The shares were issued pursuant to the Company’s registration statements filed with the U.S. Securities and Exchange Commission on a prospectus supplement on October 31, 2017 and Form S-1 on November 20, 2017.
Note 9.8. Stock Option Plans and Warrants to Purchase Common Stock
Stock Option Plans
The Amended and Restated 2005 Equity Incentive Plan (“2005 Plan”) was replaced by the 2015 Equity Incentive Plan, (“2015 Plan”), which was approved in June 2015. No securities are available for future issuance under the 2005 Plan. In September 2022, the stockholders approved an amendment to the 2015 Plan to increase the maximum number of shares of common stock available for issuance under the plan by 4,000,000 shares. As of December 31, 2017, a maximum of 600,0002023, there are 5,096,447 shares arecurrently available for grants under the 2015 Plan, and arePlan. The plan is divided into four separate equity programs:
| 1) | the Discretionary Option Grant Program, under which eligible persons may, at the discretion of the Plan Administrator, be granted options to purchase shares of common stock, |
| 2) | the Salary Investment Option Grant Program, under which eligible employees may elect to have a portion of their base salary invested each year in options to purchase shares of common stock, |
| 3) | the Automatic Option Grant Program, under which eligible nonemployee Board members will automatically receive options at periodic intervals to purchase shares of common stock, and |
| 4) | the Director Fee Option Grant Program, under which non-employee Board members may elect to have all, or any portion, of their annual retainer fee otherwise payable in cash applied to a special option grant. |
F-20
Shares available for grant under the 2015 Plan were as follows:
The 2005 Equity Incentive Plan (“2005 Plan”) also was divided into four separate equity programs:
| | |
The 2005 Plan expired in 2015 and thus no securities remain available for future issuance under that plan.
The table below accounts only for transactions occurring as part of the 2015 Plan.
Shares available for grant at January 1, | 5,812,991 | |||
Options granted | (731,544) | |||
Options | 15,000 | |||
Options | | — | ||
Shares available for grant at December 31, | 5,096,447 |
The total option activity forActivity under the 2005 Plan and the 2015 Plan for the years ended December 31, 20172023 and 2016 was as follows:2022
| | | | | |
|
|
|
| Weighted | |
| | | | Average | |
| | | | Exercise | |
|
| Options |
| Price | |
Balance outstanding at December 31, 2021 |
| 140,996 | | $ | 37.12 |
Granted |
| 55,730 | |
| 8.85 |
Forfeited |
| (3,908) | |
| 107.83 |
Cancelled | | (545) | | | 11.70 |
Exercised | | — | | | — |
Balance outstanding at December 31, 2022 |
| 192,273 | | $ | 27.56 |
Granted |
| 731,544 | |
| 0.65 |
Forfeited |
| (16,925) | |
| 34.71 |
Cancelled | | — | | | — |
Exercised |
| — | |
| — |
Balance outstanding at December 31, 2023 |
| 906,892 | | $ | 5.73 |
Options | Weighted Average Options Exercise Price | |||||||
| Balance outstanding at December 31, 2015 | 276,861 | $ | 21.30 | |||||
| Granted | 66,875 | 5.30 | ||||||
| Increase post reverse stock split | 1,851 | 17.07 | ||||||
| Exercised | - | - | ||||||
| Forfeited | (14,982 | ) | 48.52 | |||||
| Balance outstanding at December 31, 2016 | 330,605 | $ | 17.07 | |||||
| Granted | 476,100 | 2.24 | ||||||
| Exercised | - | - | ||||||
| Forfeited | (21,050 | ) | 51.62 | |||||
| Balance outstanding at December 31, 2017 | 785,655 | $ | 7.15 | |||||
As of December 31, 2017,2023, there were 439,963306,588 options exercisable with a weighted average exercise price of $10.77$15.01 and a weighted average remaining contractual term of 7.067.99 years. As of December 31, 2017,2023, there were 785,655906,892 options outstanding with a weighted average remaining term of 8.189.25 years.
Options outstanding as of December 31, 2023 had no intrinsic value.
The Company awarded 476,100731,544 and 66,87555,730 stock options during the years ended December 31, 20172023 and 2016,2022, respectively, which had a weighted average grant date fair value per share of $1.54$0.50 and $3.90,$5.57, respectively. The weighted-average exercise price, by price range, for outstanding options to purchase common stock at December 31, 20172023 was:
Price Range | Weighted Average Remaining Contractual Life in Years | Outstanding Options | Exercisable Options | |||||||||||
| $2.01-$19.50 | 8.60 | 705,274 | 359,582 | |||||||||||
| $20.00-$41.00 | 5.28 | 59,581 | 59,581 | |||||||||||
| $46.40-$62.00 | 2.44 | 20,800 | 20,800 | |||||||||||
| Total | 8.18 | 785,655 | 439,963 | |||||||||||
| | | | | | |
|
| Weighted |
|
|
|
|
| | Average | | | | |
| | Remaining | | | | |
| | Contractual | | Outstanding | | Exercisable |
Price Range |
| Life in Years |
| Options |
| Options |
$0.59 - $40.05 |
| 9.31 |
| 899,794 |
| 299,490 |
$111.00- $328.50 |
| 1.52 |
| 7,098 |
| 7,098 |
Total |
| 9.25 |
| 906,892 |
| 306,588 |
The Company’s share-based compensation expense for the years ended December 31, 20172023 and 20162022 was recognized as follows:
| | | | | | | ||||||||
| Share-based compensation | 2017 | 2016 |
| 2023 |
| 2022 | ||||||||
| Research and development | $ | 213,944 | $ | 230,573 | | $ | 150,466 | | $ | 142,879 | ||||
| General and administrative | 275,843 | 344,404 | |
| 219,716 | |
| 190,510 | ||||||
| Total | $ | 489,787 | $ | 574,977 | | $ | 370,182 | | $ | 333,389 | ||||
At December 31, 2017,2023, the total compensation cost for stock options not yet recognized was approximately $512,766$421,000 and will be expensed over the next three years.
F-21
Warrants to Purchase Common Stock
As described in Note 6. Warrant Liability, during November 2016, the Company entered into amendments with the holders of the price protected warrants issued in the June 2013 registered public offering eliminating the “down round” provision and permitting those warrants to be exercised on a “cashless exercise” basis. Of the 303,694 shares of common stock that remained issuable on the date of the amendments upon the exercise of such warrants, warrants to purchase a total of 42,444 shares were exercised on a cashless basis on November 9, 2016. The fair value of the warrant liability of $892,860 related to the remaining 261,250 warrants outstanding after the amendment and exercises was reclassified to equity as the amended terms of the warrants qualified them to be accounted for as equity instruments.
On December 16, 2016, 1,670,000 shares of our common stock and warrants to purchase 2,087,500 shares of the Company’s common stock at a combined offering price of $3.16 were issued in a registered public offering. In addition, the underwriters partially exercised the over-allotment to purchase an additional 282,505 warrants. Commencing on the date of issuance, holders of the warrants may exercise their right to acquire the common stock and pay an exercise price of $3.95 per share, prior to five years from the date of issuance, after which date any unexercised warrants will expire and have no further value. The warrants are traded on the Nasdaq Capital Market under the symbol “SNGXW”.
In connection with the registered public offering, a warrant to purchase 33,400 shares of the Company’s common stock was issued to the representative of the underwriters of the offering. The warrant is exercisable at $3.95 per share of common stock underlying the warrant for a four-year period commencing one year from the effective date of the offering.
On November 3, 2017, 1,575,500 shares of common stock were issued at a purchase price of $2.00 per share and 982,000 shares of common stock were issued at a purchase price of $2.00 per share in a concurrent private placement. In connection with the concurrent registered public offering and the private placement, warrants to purchase 51,151 shares of the Company’s common stock were issued to the representatives of the underwriters of the offering. The warrants are exercisable at $2.50 per share of common stock underlying the warrants for a four-year period commencing six months from the effective date of the offering.
Warrant activity for the years ended December 31, 20172023 and 20162022 was as follows:
| | | | | | |
|
|
| |
| Weighted | |
| | | | | Average | |
| | | | | Exercise | |
|
| Warrants |
| Price | ||
Balance at December 31, 2021 |
| | 221,872 | | $ | 33.79 |
Granted |
| | — | |
| — |
Exercised |
| | — | |
| — |
Expired |
| | (221,205) | |
| 33.81 |
Balance at December 31, 2022 |
| | 667 | | $ | 29.25 |
Granted |
| | 10,775,073 | |
| 0.91 |
Exercised |
| | (4,237,000) | |
| 0.001 |
Expired |
| | (667) | |
| 29.25 |
Balance at December 31, 2023 | | | 6,538,073 | | $ | 1.50 |
| Warrants | Weighted Average Exercise Price | |||||||
| Balance at December 31, 2015 | 492,614 | $ | 7.40 | |||||
| Granted | 2,403,405 | 3.95 | ||||||
| Exercised | (42,444 | ) | 0.80 | |||||
| Balance at December 31, 2016 | 2,853,575 | $ | 4.13 | |||||
| Granted | 51,151 | 2.50 | ||||||
| Exercised | (250,000 | ) | 0.80 | |||||
| Expired | (77,488 | ) | 5.58 | |||||
| Balance at December 31, 2017 | 2,577,238 | $ | 4.38 | |||||
The remaining life, by grant date, for outstanding warrants at December 31, 20172023 was:
Grant Date | Exercise Price | Remaining Contractual Life in Years | Outstanding Warrants | Exercisable Warrants | ||||||||||||
| 6/25/2013 | 0.80 | 0.48 | 11,250 | 11,250 | ||||||||||||
| 12/5/2013 | 20.50 | 0.93 | 500 | 500 | ||||||||||||
| 12/24/2014 | 14.80 | 1.98 | 110,932 | 110,932 | ||||||||||||
| 12/16/2016 | 3.95 | 3.96 | 2,403,405 | 2,403,405 | ||||||||||||
| 11/3/2017 | 2.50 | 4.83 | 51,151 | - | ||||||||||||
| Total | 3.78 | 2,577,238 | 2,526,087 | |||||||||||||
| | | | | | | | | |
|
|
| |
| Remaining |
|
|
|
|
| | Exercise | | Contractual | | Outstanding | | Exercisable | |
Grant Date |
| Price |
| Life in Years |
| Warrants |
| Warrants | |
May 09, 2023 | | $ | 1.50 |
| 4.36 |
| 6,538,073 |
| 6,538,073 |
Note 10.9. Concentrations
At December 31, 20172023 and 2016,2022, the Company had deposits in major financial institutions that exceeded the amount under protection by the Securities Investor Protection Corporation (“SIPC”) and the Federal Deposit Insurance Corporation (“FDIC”). Currently, the Company is covered up to $1,000,000$250,000 by the SIPC and FDIC and at times maintains cash balances in excess of the SIPC coverage.and FDIC coverages.
Note 11.10. Commitments and Contingencies
The Company has commitments of approximately $500,000 at$230,000 as of December 31, 20172023 over the next five years for several licensing agreements with consultantspartners and universities. Additionally, the Company has collaboration and license agreements, which upon clinical or commercialization success, may require the payment of milestones of up to $7.9approximately $13.2 million, and/or royalties up to 6% ofon net sales of covered products ranging from 2% to 3%, sub-license income royalties on covered products up to 15% and sub-license global net sales royalties on covered products ranging from 1.5% to 2.5%, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur. As of December 31, 2017, the Company has accrued for approximately $197,000 in milestone payments.
The Company currently leases approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey pursuant to a lease that was amended in October 2017 and expires in October 2020.Jersey. This office space currently serves as the Company’s corporate headquarters.headquarters, and both of the Company’s business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. Pursuant to an amendment on June 21, 2022, the lease has been extended from November 2022 to October 2025. The current rent for the first 12 months is approximately $11,367 per month or approximately $22.00 per square foot.and will remain so through October 2024. The rent will increase tofor the lease period starting November 2024 is approximately $11,625 per month, or approximately $22.50 per square foot, for the next 12 months and increase to approximately $11,883 per month, or approximately $23.00 per square foot for the remainder of the lease.
month.
On September 3, 2014, the Company entered into an asset purchase agreement with Hy Biopharma, Inc. (“Hy Biopharma”) pursuant to which the Company acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, the Company paid $275,000 in cash and issued 184,91212,328 shares of common stock with a fair value based on the Company’s stock price on the date of grant of $3,750,000.$3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in the Company’s research and development activities and do not have alternative future use pursuant to generally accepted accounting principles in the United States. U.S. In March 2020, the Company issued 130,413 fully vested shares of common stock to Hy Biopharma as payment for achieving a milestone: the Company determining the Phase 3 clinical trial of HyBryte™ to be successful in the treatment of CTCL. The number of shares of common stock issued
F-22
to Hy Biopharma was calculated using an effective price of $38.40 per share, based upon a formula set forth in the purchase agreement.
Provided allthe sole remaining future success-oriented milestones aremilestone of FDA approval is attained, the Company will be required to make an additional paymentspayment of up to $10.0$5 million, if and when achieved. PaymentsSuch payment will be payable in restricted securities of the Company provided they dosuch number of shares does not exceed 19.9% ownership of the Company’s outstanding stock. As of December 31, 2017,2023, no other milestone or royalty payments have been paid or accrued.
In February 2007,January 2020, the Company’s Board of Directors authorized the issuanceamendment of 5,000Dr. Schaber’s employment agreement to increase the number of shares of the Company’s common stock from 334 to 33,334 issuable to Dr. Schaber immediately prior to the completion of a transaction, or series or a combination of related transactions, negotiated by its Board of Directors whereby, directly or indirectly, a majority of its capital stock or a majority of its assets are transferred from the Company and/or its stockholders to a third party. Dr. Schaber’s amended employment agreement includes the Company’s obligation to issue such shares if such event occurs.
As a result of the above agreements, the Company has future contractual obligations over the next five years as follows:
| Year | Research and Development | Property and Other Leases | Total | |||||||||
| 2018 | $ | 100,000 | $ | 139,765 | $ | 239,765 | ||||||
| 2019 | 100,000 | 148,561 | 248,561 | |||||||||
| 2020 | 100,000 | 127,377 | 227,377 | |||||||||
| 2021 | 100,000 | 5,696 | 105,696 | |||||||||
| 2022 | 100,000 | - | 100,000 | |||||||||
| Total | $ | 500,000 | $ | 421,399 | $ | 921,399 | ||||||
| | | | | | | | | |
|
| Research and |
| Property and |
|
| | ||
Year |
| Development |
| Other Leases |
| Total | |||
2024 | | $ | 46,000 | | $ | 136,917 | | $ | 182,917 |
2025 | |
| 46,000 | |
| 116,250 | |
| 162,250 |
2026 | |
| 46,000 | |
| — | |
| 46,000 |
2027 | | | 46,000 | | | — | | | 46,000 |
2028 | | | 46,000 | | | — | | | 46,000 |
Total | | $ | 230,000 | | $ | 253,167 | | $ | 483,167 |
Contingencies
The Company follows subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable and reasonably estimable.
COVID-19
Based on the current outbreak of SARS-CoV-2, the pathogen responsible for COVID-19, which has already had an impact on financial markets, there could be additional repercussions to the Company’s operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites.
COVID-19 affected the Company’s operations but did not have a material impact on the Company’s business, operating results, financial condition or cash flows as of and for the year ended December 31, 2023.
The future impact of the outbreak is highly uncertain and cannot be predicted, and the Company cannot provide any assurance that the outbreak will not have a material adverse impact on the Company’s operations or future results or filings with regulatory health authorities. The extent of the impact to the Company, if any, will depend on future developments, including actions taken to contain the coronavirus.
F-23
Note 12.11. Operating Segments
The Company maintains two active operating segments: Specialized BioTherapeutics and Vaccines/BioDefense.Public Health Solutions. Each segment includes an element of overhead costs specifically associated with its operations, with its corporate shared services group responsible for support functions generic to both operating segments.
| For the Years Ended December 31, | ||||||||||||||
| 2017 | 2016 | |||||||||||||
| | | | | | | ||||||||
| | For the Years Ended | ||||||||||||
| | December 31, | ||||||||||||
| | 2023 |
| 2022 | ||||||||||
| Revenues | | |
|
| |
| ||||||||
| Vaccines/BioDefense | $ | 4,749,294 | $ | 10,448,794 | ||||||||||
| BioTherapeutics | 683,178 | - | ||||||||||||
Specialized BioTherapeutics | | $ | 395,124 | | $ | 31,929 | ||||||||
Public Health Solutions | | | 444,235 | | | 916,982 | ||||||||
| Total | $ | 5,432,472 | $ | 10,448,794 | | $ | 839,359 | | $ | 948,911 | ||||
| Income (Loss) from Operations | ||||||||||||||
| Vaccines/BioDefense | $ | 232,166 | $ | 1,563,884 | ||||||||||
| BioTherapeutics | (4,181,811 | ) | (3,399,933 | ) | ||||||||||
| | | | | | | ||||||||
Income (loss) from Operations | |
|
| |
|
| ||||||||
Specialized BioTherapeutics | | $ | (2,812,303) | | $ | (7,614,988) | ||||||||
Public Health Solutions | | | (36,531) | | | 26,612 | ||||||||
| Corporate | (3,644,154 | ) | (3,873,533 | ) | |
| (4,849,106) | |
| (6,650,528) | ||||
| Total | $ | (7,593,799 | ) | $ | (5,709,582 | ) | | $ | (7,697,940) | | $ | (14,238,904) | ||
| | | | | | | ||||||||
| Amortization and Depreciation Expense | |
|
| |
|
| ||||||||
| Vaccines/BioDefense | $ | 33,183 | $ | 40,186 | ||||||||||
| BioTherapeutics | 30,614 | 41,395 | ||||||||||||
Specialized BioTherapeutics | | $ | 3,932 | | $ | 10,087 | ||||||||
Public Health Solutions | | | 655 | | | 1,681 | ||||||||
| Corporate | 4,766 | 8,347 | |
| 1,967 | |
| 12,794 | ||||||
| Total | $ | 68,563 | $ | 89,928 | | $ | 6,554 | | $ | 24,562 | ||||
| Other Income, Net | ||||||||||||||
| Corporate | $ | 29,906 | $ | 1,934,056 | ||||||||||
| Share-Based Compensation | ||||||||||||||
| Vaccines/BioDefense | $ | 76,625 | $ | 99,410 | ||||||||||
| BioTherapeutics | 137,319 | 131,163 | ||||||||||||
| | | | | | | ||||||||
Other (Expense) Income, Net | |
|
| |
|
| ||||||||
Specialized BioTherapeutics | | $ | 25,267 | | $ | 102,320 | ||||||||
| Corporate | 275,843 | 344,404 | |
| (235,860) | |
| (816,690) | ||||||
| Total | $ | 489,787 | $ | 574,977 | | $ | (210,593) | | $ | (714,370) | ||||
| | | | | | | ||||||||
Share-Based Compensation | |
|
| |
|
| ||||||||
Specialized BioTherapeutics | | $ | 145,683 | | $ | 138,075 | ||||||||
Public Health Solutions | | | 4,782 | | | 4,804 | ||||||||
Corporate | |
| 219,717 | |
| 190,510 | ||||||||
Total | | $ | 370,182 | | $ | 333,389 | ||||||||
| As of December 31, | ||||||||||||||
| 2017 | 2016 | |||||||||||||
| | | | | | | ||||||||
|
| As of December 31, | ||||||||||||
| | | | | | | ||||||||
|
| 2023 |
| 2022 | ||||||||||
| Identifiable Assets |
| |
|
| |
| ||||||||
| Vaccines/BioDefense | $ | 906,416 | $ | 1,297,986 | ||||||||||
| BioTherapeutics | 116,344 | 49,422 | ||||||||||||
Specialized BioTherapeutics | | $ | 272,099 | | $ | 103,742 | ||||||||
Public Health Solutions | |
| 3,976 | |
| 121,290 | ||||||||
| Corporate | 8,526,891 | 8,919,698 | |
| 9,521,251 | |
| 14,054,685 | ||||||
| Total | $ | 9,549,651 | $ | 10,267,105 | | $ | 9,797,326 | | $ | 14,279,717 | ||||
Note 12. Subsequent Event
Convertible Debt Financing Agreement
On April 19, 2023, the Company entered into an amendment to the convertible debt financing agreement with Pontifax (See Note 5). The amendment reduced the conversion price with respect to the remaining principal amount outstanding under the agreement. The conversion price was amended to be (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 588,599 shares of our common stock issuable upon conversion and (ii) $1.70 with respect to all shares of our common stock issuable upon conversion in excess of the first 588,599 shares so issued.
F-24
Conversion of Promissory Notes
On January 3, 2024, the Company issued an aggregate of 146,199 shares of common stock to two lenders upon conversion of approximately $100,000 of principal under promissory notes at a conversion price of $0.68 per share.
Remaining Convertible Debt
As of March 8, 2024, $2,900,585 of principal and $45,840 of accrued interest remain outstanding under the agreement. The conversion price for the remaining principal amount as of March 8, 2024 is (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 442,400 shares of common stock issuable upon conversion and (ii) $1.70 with respect to all shares issuable upon conversion in excess of the first 442,400 shares so issued.
F-25
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
TheTo the Board of Directors and Stockholders of
Soligenix, Inc.
Princeton, New Jersey
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheetssheet of Soligenix, Inc. and Subsidiaries (the ‘‘Company’’“Company”) as of December 31, 2017 and 2016,2023, and the related consolidated statements of operations, shareholders’stockholders’ equity (deficit) and cash flows for each of the years thenyear ended December 31, 2023, and the related notes (collectively referred to as the ‘‘financial statements’’“financial statements”). In our opinion, the financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2017 and 2016,2023, and the consolidated results of theirits operations and theirits cash flows for each of the years thenyear ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has recurring losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management’s evaluations of the events and conditions and management’s plans regarding those matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Prior Period Financial Statements
The financial statements of the Company as of December 31, 2022 were audited by other auditors whose report dated March 31, 2023 expressed an unqualified opinion on those statements.
Basis for Opinion
These financial statements are the responsibility of the Company’sCompany's management. Our responsibility is to express an opinion on the Company’sthese financial statements based on our audits.audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (‘‘PCAOB’’(“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our auditsaudit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our auditsaudit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our auditsaudit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our auditsaudit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provideaudit provides a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on the financial statements,
F-26
taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.
Critical Audit Matter Description
As disclosed in Note 5 to the financial statements, on April 19, 2023, the Company amended the convertible debt financing agreement dated December 15, 2020 with Pontifax. The Company has elected the fair value option and has accounted for the Pontifax note at fair value.
There is no current observable market for the Pontifax note and, as such, the Company determined the fair value using the Monte Carlo pricing model. As a result, a high degree of auditor judgment and effort was required in performing audit procedures to evaluate the valuation technique and the significant unobservable inputs.
How the Critical Audit Matter was Addressed in the Audit
Our principal audit procedures performed to address this critical audit matter included the following:
| ● | We obtained an understanding and evaluated the Company’s election of accounting policy related to the Pontifax note. |
| ● | We obtained an understanding and evaluated the Company’s process and methodology used in the valuation of the Pontifax note. |
| ● | We reviewed the fair value model used, significant assumptions, and underlying data used in the model and evaluated whether the estimates and assumptions were consistent with audit evidence obtained. |
| ● | We evaluated the disclosures surrounding the fair value election with respect to the Pontifax note and ensured that these were disclosed in accordance with the relevant accounting guidance. |
/s/ EisnerAmperCherry Bekaert LLP
We have served as the Company’s auditor since 2010.2023.
Tampa, Florida
March 15, 2024
F-27
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Soligenix, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of Soligenix, Inc and Subsidiaries (the “Company”) as of December 31, 2022, and the related consolidated statements of operations, comprehensive loss, changes in mezzanine equity and shareholders’ equity (deficit), and cash flows for the year then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2022, and the consolidated results of their operations and their cash flows for the year then ended, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations and expects to incur losses for the foreseeable future, that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ EisnerAmper LLP
We have served as the Company’s auditor from 2010 to 2022.
EISNERAMPER LLP
Iselin, New JerseyYork, New York
March 15, 201831, 2023
F-24F-28