2915 Commers Drive, Suite 900
Eagan, Minnesota 55121
(651) 389-4800
(Address and telephone number of registrant’s principal executive offices and principal place of business)
Bob Myers Chief Financial Officer Predictive Oncology Inc. 2915 Commers Drive, Suite 900 Eagan, Minnesota 55121 (651) 389-4800 (Name, address and telephone number of agent for service) | Copy to: Martin R. Rosenbaum, Esq. Maslon LLP 3300 Wells Fargo Center 90 South 7th Street Minneapolis, Minnesota 55402 Telephone: (612) 672-8200 Facsimile: (612) 672-8397 |
Approximate date of commencement of proposed sale to the public: From time to time on or after the effective date of this Registration Statement.
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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one)
| Large accelerated filer ☐ | Accelerated filer ☐ |
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Emerging growth company ☐
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CALCULATION OF REGISTRATION FEE
| Title of Each Class of Securities to be Registered | Amount to be Registered(1) | Proposed Maximum Offering Price Per Security (1)(2) | Proposed Maximum Aggregate Offering Price | Amount of Registration Fee (2) |
| Common stock, $0.01 par value per share | 9,713,526 | $1.355 | $ 13,161,827.73 | $1,435.96 |
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
ii
The information in this prospectus is not complete and may be changed. We mayThe selling stockholders not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
PRELIMINARY PROSPECTUS,
SUBJECT TO COMPLETION - DATED JANUARY 29, 2021September 30, 2022
PRELIMINARY PROSPECTUS
PREDICTIVE ONCOLOGY INC.
9,713,526
4,737,280 Shares
Common Stock
This prospectus relates to the offer and resale from time to time by the selling stockholders named in this prospectus of up to 9,713,526an aggregate of 4,737,280 shares of our common stock, par value $0.01 per share,share. These shares consist of (i) 3,837,280 shares of common stock issuable upon the exercise of common stock purchase warrants that were initially issued in a private placement to certain institutional and accredited investors and (ii) 900,000 shares of common stock issuable upon the exercise of placement agent warrants that were initially issued to certain designees of H.C. Wainwright & Co., LLC (“Wainwright”), as part of Wainwright’s compensation for serving as our exclusive placement agent in connection with the private placement and two concurrent registered direct offerings completed on May 18, 2022.
Our registration of the securities covered by Oasis Capital, LLC (“Oasis Capital”),this prospectus does not mean that the selling stockholder. Oasis Capital has agreed to purchase from us pursuant to the terms and conditions of an Equity Purchase Agreement that we entered into with Oasis Capital on October 24, 2019 (the “Equity Purchase Agreement”). Subject to the terms and conditionsstockholders will offer or sell any of the Equity Purchase Agreement, we originally had the right to “put,” or sell, at our discretion, up to $15,000,000 worth of shares of ourcommon stock. The selling stockholders may sell or otherwise dispose of the shares of common stock to Oasis Capital. This arrangement is also sometimes referred to herein as the “Equity Line”publicly or the “Oasis Equity Line.” As of the date of this prospectus, there remains $9,789,419 worth of shares of our common stock available for future sales under the Equity Line.
Forthrough private transactions at prevailing market prices or at negotiated prices. We provide more information about how the selling stockholder, please seestockholders may sell their shares in the section entitled “Plan of this prospectus entitled “Selling Stockholder” beginning on page 21.Distribution.”
The
One or more of the selling stockholderstockholders may sell any shares offered under this prospectus at fixed prices, prevailing market prices at the time of sale, at varying prices or negotiated prices.
Oasis Capital is an “underwriter”be deemed to be “underwriters” within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), in connection with the resale of our common stock understock. We will bear all costs, expenses and fees in connection with the Equity Line, and any broker-dealers or agents that are involved in such resales may be deemed to be “underwriters” within the meaningregistration of the Securities Act in connection therewith. In such event,shares. The selling stockholders will bear all commissions and discounts, if any, commissions received by such broker-dealers or agents and any profit on the resaleattributable to their respective sales of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. For more information, please see the section of this prospectus titled “Plan of Distribution” beginning on page 22.shares.
We will not receive any proceeds from the resalesale of shares of common stock by the selling stockholder.stockholders. We will, however, receive the proceeds from any exercise of the sale of shares directly to Oasis Capital pursuant to the Equity Line. warrants for cash.
Our common stock is listed on the Nasdaq Capital Market under the symbol “POAI.” On January 26, 2021,September 29, 2022, the last reported per share price of our common stock on the Nasdaq Capital Market was $1.33$0.3641 per share.
Investing in our common stock involves a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks that we have described beginning on page 1311 of this prospectus under the caption “Risk Factors” and in the documents incorporated by reference into this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is [•], 2021.
Table of Contents
2022.
Table of Contents
| Page | |
| About this Prospectus | 1 |
| Industry and Market Data | 1 |
| The Company | 2 |
| Offering Summary | 10 |
| Risk Factors | 11 |
| Cautionary Note Regarding Forward Looking Statements | 11 |
| Use of Proceeds | 12 |
| Description of Capital Stock | 12 |
| Selling Stockholders | 15 |
| Plan of Distribution | 17 |
| Legal Matters | 18 |
| Experts | 18 |
| Where You Can Find More Information | 18 |
| Incorporation of Certain Documents by Reference | 18 |
ABOUT THIS PROSPECTUS
We urge you to read carefully this prospectus, together with the information incorporated herein by reference as described under “Incorporation of Certain Documents by Reference” before buying any of the securities offered.
This prospectus is part of a registration statement that we have filed with the Securities and Exchange Commission (the “SEC”) pursuant tounder which the selling stockholders named herein may, from time to time, offer and sell or otherwise dispose of the securities covered by this prospectus. You should not assume that the information contained in this prospectus is accurate on any date subsequent to the date set forth on the front cover of this prospectus or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus is delivered or securities are sold or otherwise disposed of on a later date. It is important for you to read and consider all information contained in this prospectus, including the Information Incorporated by Reference herein, in making your investment decision. You should also read and consider the information in the documents to which we have referred you under the captions “Where You Can Find More Information” and “Incorporation of Information by Reference” in this prospectus.
Neither we nor the selling stockholders have authorized any dealer, salesmanA prospectus supplement may add, update or other person to give anychange information or to make any representation other than those contained or incorporated by referenceincluded in this prospectus. You should not rely upon any information or representation not contained or incorporated by reference in this prospectus. This prospectus does not constitute an offer to sell or the solicitation of an offer to buy any of our securities other than the securities covered hereby, nor doesread both this prospectus constitute an offer to sell orand any applicable prospectus supplement together with additional information described below under the solicitation of an offer to buy any securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about, and to observe, any restrictions as to the offering and the distribution of this prospectus applicable to those jurisdictions.heading “Where You Can Find Additional Information.”
We further note that the representations, warranties and covenants made in any agreement that is filed as an exhibit to any document that is incorporated by reference in the prospectus were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
Unless the context otherwise requires, references in this prospectus to “Predictive,” the “Company,” “we,” “us,” and “our” refer to Predictive Oncology Inc.
You should rely only on the information contained or incorporated by reference in this prospectus and any applicable prospectus supplement. Neither we nor the selling stockholders have authorized anyone to provide you with different information, and if anyone provides, or has provided you, with different or inconsistent information, you should not rely on it. We and the selling stockholders take no responsibility for, and can provide no assurance as applicable,to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the securities offered hereby and only under circumstances and in jurisdictions where it is lawful to do so. This prospectus is not an offer to sell securities, and it is not soliciting an offer to buy securities, in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus, any prospectus supplement or other offering materials related to an offering of securities described in this prospectus. We have not authorized anyone to provide you with different or additional information. If anyone provides you with different or additional information, you should not rely on it.
You should not assume that the information contained ordocuments incorporated by reference as applicable, in this prospectus, any prospectus supplement, or other offering materials related to an offering of securities described in this prospectusherein is accurate only as of any date other than the date of that document. Neither the document containing the information, regardless of the time of delivery of this prospectus or any applicable prospectus supplement or other offering materials related to an offeringany sale of securities described in this prospectus, nor any distribution of securities pursuant to this prospectus, any such prospectus supplement, or other offering materials shall, under any circumstances, create any implication that there has been no change in the information set forth or incorporated by reference, as applicable, in this prospectus, any such prospectus supplement or other offering materials since the date of each such document.a security. Our business, financial condition, results of operations and prospects may have changed since those dates.
This prospectus does not constitute, and any prospectus supplement
For investors outside of the United States, neither we nor the selling stockholders have done anything that would permit this offering or other offering materials related to an offeringpossession or distribution of securities described in this prospectus will not constitute, an offer to sell, or a solicitation of an offer to purchase, the offered securities in any jurisdiction where action for that purpose is required, other than in the United States. You are required to or frominform yourselves about, and to observe any personrestrictions relating to, whom or from whom it is unlawful to make such offer or solicitation in such jurisdiction.this offering and the distribution of this prospectus outside of the United States.
INDUSTRY AND MARKET DATA
This prospectus and the information incorporated by reference herein contain market and industry statistics that are based on various sources that we believe is accurate. It is generally based on academic and other publications that are not produced for purposes of securities offerings or economic analysis. We believe the data contained in these reports or publications to be reliable as of the date of this prospectus, but there can be no assurance as to the accuracy or completeness of such information. We have not independently verified the market and industry data obtained from these sources. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and the additional uncertainties accompanying any estimates of future market size, revenue and market acceptance of products and services.
THE COMPANY
This summary contains basic information about us. You should carefully read the entire prospectus carefully, especiallyand the risks of investing in our securities discussed under “Risk Factors.”documents we incorporate by reference herein. Some of the statements contained in this prospectus and the documents incorporated by reference herein, including statements under this summary and “Risk Factors”, are forward-looking statements and may involve a number of risks and uncertainties. We note that our actual results and future events may differ significantly based upon a number of factors. You should not put undue reliance on the these forward-looking statements in this document, which speak only as of the date on the cover of this prospectus.statements. References to “we,” “our,” “us,” the “Company,” or “Predictive” refer to Predictive Oncology Inc., a Delaware corporation.
Business Overview
Predictive Oncology Inc. (NASDAQ: POAI) operates
We operate in twofour primary business areas: first, application of artificial intelligence (“AI”) in our precision medicine business, to provide AI-driven predictive models of tumor drug response to improve clinical outcomes for patients and to assist pharmaceutical, diagnostic, and biotech industries in the development of new personalized drugs and diagnostics; second, tumor-specific 3D cell culture models driving accurate prediction of clinical outcomes; third, contract services and second,research focused on solubility improvements, stability studies, and protein production, and; fourth, production of the United States Food and Drug Administration (“FDA”)-cleared STREAMWAY® System for automated, direct-to-drain medical fluid disposal and associated products.products
We have three operating divisions:four reportable segments: Helomics®, zPREDICTA®, SolubleTM and Skyline®. The Helomics segment includes clinical testing and contract research services that include the application of AI. Our zPREDICTA segment specializes in organ-specific disease models that provide 3D reconstruction of human tissues accurately representing each disease state and mimicking drug response enabling accurate testing of anticancer agents. Our Soluble segment provides services using a self-contained, automated system that conducts high-throughput, self-interaction chromatography screens, using additives and excipients commonly included in protein formulations resulting in soluble and physically stable formulations for biologics. Our Skyline Medical, Helomics and Soluble. Skylinesegment consists of the STREAMWAY System product sales. The Helomics division consists of clinical testingsales, and contract research. Our Soluble Biotech divisionour TumorGenesis® subsidiary (Research and Development) is a provider of soluble and stable formulations for proteins. Our TumorGenesis subsidiary specializes in media’s that help cancer cells grow and retain their DNA/RNA and proteomic signatures providing researchers with a tool to expand and study cancer cell types found in tumors of the blood and organ systems of all mammals, including humans.included within corporate. Going forward, we have determined that we will focus our resources on the Helomics divisionand zPREDICTA segments and our primary mission statements to accelerate patient-centric drug discovery to improve patient outcomes in cancer treatment, harnessing the power of applying AI, and to precision medicine and drug discovery.develop tumor-specific 3D cell culture models that provide accurate 3D reconstruction of human tissues representing each cancer disease state.
On November 24, 2021, we acquired zPREDICTA, Inc. (“zPREDICTA”) in a merger transaction, and at that time we identified zPREDICTA as a reportable segment. zPREDICTA’s business, which involves integration of organ-specific cellular and extracellular elements into 3D culture models for in vitro cancer drug testing, represents a unique segment in the Predictive offerings.
Precision Medicine Business
Our precision medicine business, conducted in our Helomics division, is committed to improving the effectiveness of cancer therapy using our proprietary, multi-omic tumor profiling platform, one-of-a-kind database of historical tumor data, and the power of AI to build predictive models of tumor drug response.
Helomics’ mission is to improve clinical outcomes for patients by partnering with pharmaceutical, diagnostic, and academic organizations to bring innovative clinical products and technologies to the marketplace. In addition toOur Patient-centric Drug Discovery using Active Learning asset (“PeDAL”™) is a unique technology that combines our proprietary, patient-derivedclinically validated patient tumor cell line assay (“PDx”TruTumor”™), a vast knowledgebase of proprietary and public data together (“TumorSpace”™) tumor profiling platform for oncology, Helomics offers: 1) datawith active learning - the active learning allowing the efficient exploration of compound drug responses against a large diverse patient “space”. PeDAL offers researchers the opportunity to efficiently and AI driven contract research organization (“CRO”) services for clinicalcost-effectively bring patient diversity much earlier in the drug discovery process. PeDAL works by iterative cycles of active-learning powered Learn-Predict-Test to guide the testing of patient-specific compound responses using the TruTumor assay and translational researchpatient cell lines to build a comprehensive predictive model of patient responses to compounds. This predictive model can then be used to rank compounds by the fraction of patients of certain profiles that leverage PDx tumor models, 2) a wide rangerespond as well as the set of multi-omics assays (genomics, proteomics, and biochemical), and 3) AI driven predictive models to drivecompounds that provide the discovery of targeted therapies.best coverage across patients. PeDAL will be used in fee-for-service projects with pharmaceutical companies.
Contract Research Organization (CRO)(“CRO”) and AI-Driven Business
We believe leveraging our unique, historical database of the drug responses of over 150,000 patient tumors to build AI and data-driven multi-omic predictive models of tumor drug response and outcome will provide actionable insights critical to both new drug development and individualizing patient treatment. Our large historical databaseThrough the course of over 15 years of clinical testing of the responses of patient tumors to drugs, Helomics has amassed a huge proprietary knowledgebase of 150,000 patient cases. This data has been rigorously de-identified and relatedaggregated to build a unique, proprietary model of tumor drug response that we call TumorSpace. The TumorSpace model and its data plus our ability to obtainprovide a priori knowledge for the associated patient outcome data ismachine learning approaches we employ as part of the PeDAL approach.
TumorSpace model provides a significant competitive advantage. Cancer treatments requireadvantage to our business offerings. PeDAL's unique patient and tumor-centric AI-driven approach can rapidly and cost-effectively screen hundreds of compounds in thousands of tumor cell lines, and gain valuable information about off-target effects and deliver:
| · | A ranked list of drug candidates by responsiveness | |
| · | Sets of drug candidates that provide maximum patient coverage | |
| · | Biomarker profiles of patients that respond to specific drug candidates |
PeDAL also can deliver drug candidates targeted at least 5 yearsa specific patient profile as early as the hit-to-lead stage of testingdiscovery, significantly increasing the chance of clinical success, leading to provide sufficient information on progression-free survival rates. While competitors must wait for this data, we can leverage it today. These AI-driven predictive models, coupled witha dramatic improvement in both the PDx platform will create a unique service to drive revenue generating projects with pharma, diagnosticsuccess, time, and biotech companies in areas such as biomarkercost of your oncology discovery drug screening, drug repurposing, and clinical trials.programs. The AI-driven models will, once validated, also provide clinical decision support to help oncologists individualize treatment.
Our CRO/AI business is committed to improving the process of targeted therapy discovery. Our proprietary, TruTumor multi-omic PDxleverages our core competence in profiling and AI platform coupled to our vast multi-omic database of biochemical and clinical information on patients with cancer, uses deep learning to understand the association between the mutational profile of a patient’s tumor and the drug response profile of patient tumors. Our large knowledgebase of tumor drug response and other data, together with proven AI, has created a unique capability for oncology drug discovery that allows for the highly efficient screening of drug responses from thousands of diverse, well-characterized patient primary tumor that is grown in the lab.cell lines. This novel disruptive patient-centric approach is used to build an AI-driven predictive model that offers actionable insights of which mutations in the tumor are associated with drugs to which the tumor is sensitive and which will leadideally suited to the optimal outcomeearly part of drug discovery (especially hit-to-lead, lead optimization, and pre-clinical), resulting in better prioritization of compounds and better coverage of patient diversity. This will dramatically improve the chances of successfully translating discoveries, resulting in lowered costs, shortened timelines, and most importantly enhanced “speed-to-patient” for the patient.new therapies.
Our CRO services business applies these AI-driven predictive models coupled with our unique proprietary TruTumor PDx modelPeDAL to address a range of needs from discovery through clinical and translational research, to clinical trials and diagnostic development and validation as noted below:
Research
| • | Biomarker discovery | |
| • | Drug discovery | |
| • | Drug-repurposing |
Development
| • | Patient enrichment & selection for trials | |
| • | Clinical trial optimization | |
| • | Adaptive trials |
Clinical Decision Support
| • | Patient stratification | |
| • | Treatment selection |
We believe this market segment has significant growth potential and we believe we are differentiated from traditional CRO’s and other precision medicine and AI companies through these unique assets:
• clinically validated PDx platform;
• database of over 150,000 tumor cases;
• experienced AI team and AI platform;
• ability
| · | Clinically validated TruTumor platform; | |
| · | TumorSpace model of over 150,000 tumor cases; | |
| · | Experienced AI team and AI/Core® platform; | |
| · | Ability to access outcome data going back over ten years for over 120,000 of the tumor cases in our database. |
3
Industry and Market Background and Analysis – Precision Medicine Business
Precision medicine is an emerging approach for disease treatment and prevention that considers individual variability in genes, disease, environment, and lifestyle for each case to develop effective therapies. This approach allows doctors and researchers to predict more accurately which treatment, dose, and therapeutic regimen could provide the best possible outcome. The global precision medicine market is estimated to reach $141.7 billion by 2026, up from $43.6 billion in 2016. This growth is supported by the industry’s investment in precision medicine, with leading biopharmaceutical companies doubling their investments in the technology over the last five years, with the potential to increase by an additional 33% over the next five years (Source: BIS Research’s Global Precision Medicine Market to Reach $141.70 Billion by 2026, December 2017).
Precision medicine, precisely targeting drugs based on the genomic profile of the patient, has become the aspiration for cancer therapy. Over the past several decades, researchers have identified molecular patterns that are useful in defining the prognosis of a given cancer, determining the appropriate treatments, and designing targeted treatments to address specific molecular alterations. The objective of this precision medicine as directed towards cancer therapyoncology is to develop treatments tailored to the genetic changes in each person’s cancer, intended to improve the effectiveness of the therapeutic regimen, and minimize the treatment’s effects on healthy cells. However, for a majority of patients the reality is that while many mutations in the patient’s tumor can be identified most are not actionable with current protocols.protocols, due to a lack of research regarding which mutations in a tumor confer a sensitivity to a particular drug. As a result, the impact of targeted therapies is low, and uptake in clinical practice is inconsistent.
There is now a growing realization that genomics alone will not be enough to achieve the promise of personalized therapeutics, especially for cancer. A multi-omic approach (e.g., assessing the genome, transcriptome, epigenome, proteome, responseome, and microbiome) provides researchers and clinicians the comprehensive information necessary for new drug development and individualized therapy. Comparatively, the multi-omic approach provides a three-dimensional, 360-degree view of the cancer, while genomics alone is just a flat, one-dimensional view. However, multi-omic data is difficult to access quickly as it is both costly and time consuming to initiate prospective data collection, and few comprehensive, multi-omic datasets exist, especially specific to cancer. Our Helomics TumorSpace database addresses this need.
Clinical Testing
Via our Helomics subsidiary, we offer a group of clinically relevant, cancer-related tumor profiling and biomarker tests for gynecological cancers that determine how likely the patient is to respond to various types of chemotherapy and which therapies might be indicated by relevant tumor biomarkers.
Clinical testing is comprised of ChemoFxTumor Drug Response Testing (formerly ChemoFx) and BioSpeciFxGenomic Profiling (formerly BioSpeciFx) tests. The ChemoFx testTumor Drug Response Testing determines how a patient’s tumor specimen responds to a panel of various chemotherapy drugs, while the BioSpeciFx testGenomic Profiling evaluates the expression of a specific genes, or biomarkers, in the patient’s tumor. Our proprietary TruTumor™ PDxTruTumor tumor platform provides us with the ability to work with actual live tumor cells to study the unique biology of the patient’s tumor in order to understand how the patient responds to treatment.
Testing involves obtaining tumor tissue during biopsy or surgery which is then sent to our Clinical Laboratory Improvement Amendments (“CLIA”) certified laboratory using a special collection kit. Two samples ofTumor Drug Response Testing is a fresh tissue platform that uses the tumor tissue are obtained, fixed and live. The fixed tumor tissue is tested for a panel of biomarkers using a combination of Immunohistochemistry and Quantitative Polymerase Chain Reactions. Thepatient’s own live tumor tissue is grown in the labcells to help physicians identify effective treatment options for each gynecologic cancer patient.
Genomic Profiling offers a select group of clinically relevant protein expression and used to test the drug response of the tumor to a panel of standard-of-care drugs. When testing is complete a report is provided back to the cliniciangenetic mutation tests associated with recommended therapies based on the drug response and biomarker profiles. Helomics integratesdisease prognosis. Physicians can select biomarkers for testing from carefully chosen panels of relevant tests, intuitively organized by cancer pathway and tumor type. Results for these tests are presented in a clear, easy to understand format, including summaries of the drug response with other genomic and molecular data and compares it with historical data in our database to generate a roadmap that provides additional context to help the oncologist personalize patient treatment.clinical relevance of each marker.
Recently Completed Acquisitions
In May 2020, the Company acquired the businesses of Soluble Therapeutics, Inc. and BioDtech, Inc. via the purchase of substantially all of their assets. The Soluble Therapeutics business offers services to pharmaceutical and biotech companies to screen proteins for both solubility and stability, with possible applications to vaccines, antibodies and other proteins used in disease treatment. The acquired technologies also specialize in removing, identifying, and isolating endotoxins from products that are used by researchers to culture cells and to help identify endotoxins that maybe hidden within a protective matrix.
In July 2020, the Company entered into an Asset Purchase Agreement with Quantitative Medicine LLC (“QM”), a Delaware limited liability company and its owners and simultaneously completed the acquisition of substantially all of QM’s assets owned by Seller. QM is a biomedical analytics and computational biology company that developed a novel, computational drug discovery platform called CoRE. CoRE is designed to dramatically reduce the time, cost, and financial risk of discovering new therapeutic drugs by predicting the main effects of drugs on target molecules that mediate disease. In exchange for QM’s assets, including CoRE, the Company provided consideration in the form of 954,719 shares of common stock, which, when issued, had a fair value of $1,470,267. One half of the shares issued or 477,359 shares were deposited and held in escrow upon issuance, while 207,144 of the remaining shares were issued to Carnegie Mellon University (“CMU”) in satisfaction of all pre-closing amounts owed to CMU under a technology licensing agreement that was assumed by the Company on the closing date. Half of the shares held in escrow will be released on the six month anniversary of the closing date, and the other half will be released on the one year anniversary of the closing date; provided, however, that all or some of the escrow shares may be released and returned to the Company for reimbursement in the event that the Company suffers a loss against which the Selling Parties have indemnified the Company pursuant to the Agreement.
Business Strategy for Precision Medicine Business
We are a data and AI-driven discovery services company that provides AI-driven predictive models of tumor drug response to improve clinical outcomes for patients by leveraging our two primary unique assets:
| · | TruTumor - a clinically validated tumor-profiling platform
Over 38,000 of the more than 150,000 clinically validated cases in our
Through our Helomics subsidiary, we will utilize both this historical data and the
A key part of our commercialization strategy
Our commercial strategy has identified a portfolio of revenue generating project types that leverage the predictive models, our AI expertise,
The
We completed our Discovery 21 campaign, the proof of concept for PeDAL, which incorporates CoRE™, our active machine learning program, with tumor profile data and human tumor samples, to efficiently determine the most effective drug treatment for a specific cancer type. With each iteration of PeDAL, the program learns, predicts, and then directs the most informative wet lab experimentation, while building the predictive model. Discovery 21 demonstrated that a predictive model was built in an efficient manner using PeDAL and that the model revealed drug response patterns that provide insight into the treatment of ovarian cancer. This was followed by a validation round, with results demonstrating the accuracy of the model that predicted drug response. Within the clinical sector, we will be able to utilize these predictive models (once validated) for new clinical decision support tools for individualizing therapy for patients with cancer. These clinical decision support tools are a longer revenue horizon than the fee-for-service research projects with pharmaceutical companies but, importantly, will provide a steady stream of additional data generation to refine the predictive models for both clinical and research applications. zPREDICTA zPREDICTA develops tumor-specific in vitro models for oncology drug discovery and research by biopharmaceutical companies and other clients and partners. zPREDICTA’s 3D product models accelerate the drug development process for its clients and partners by leveraging the expertise in carcinogenesis, metastasis and the tumor microenvironment. It develops complex in vitro models that recapitulate the physiological environment of human tissue. From target discovery and lead optimization to preclinical evaluation of efficacy and toxicity, the objective is to develop the tools necessary to accurately identify compounds that will have the highest probability of improving human health. Product offerings include preclinical testing services based on our proprietary models directly to clients in the biopharmaceutical industry. zPREDICTA has expertise in creating human, disease-specific tissue microenvironments for testing drug efficacy and safety. Unlike other platforms, the patented 3D models utilize proprietary organ-specific extracellular matrix formulations that match the in vivo milieu of the organ of interest. These models reconstruct both cellular and extracellular compartments of each tissue, which is especially essential for testing of immuno-oncology agents. zPREDICTA technology demonstrates high clinical relevance, enabling its pharma clients to manage pipeline attrition more efficiently by identifying drugs that are effective in patients, from the hundreds, and often thousands, of compounds in development. The tumor-specific models are used by a number of biopharmaceutical companies to evaluate the efficacy and toxicity of their therapeutic pipelines. Our models replicate the extracellular matrix (“ECM”) of individual organs and disease-specific soluble microenvironment mimicking the biology of human disease, and as such, demonstrate high correlation with clinical response. The zPREDICTA 3D tumor-specific models incorporate tissue-specific extracellular matrices and tumor-specific medium supplements allowing for a true reconstruction of tumor microenvironment. Our approach is compatible with multiple classes of immuno-oncology agents from naked antibodies and antibody-drug conjugates, to bi- and tri-specific compounds, and CAR-T cells. The organ-specific disease models provide 3D reconstruction of human tissues accurately representing each disease state and mimicking drug response. Our platform incorporates both cellular and extracellular elements of tissue microenvironment in an organ- and disease-specific manner.
Our platform is designed to evaluate drug candidates and drug combinations within the native microenvironment of human tissues. Our technology is a patient-derived 3D culture platform that recreates the complex human organ microenvironment thereby preserving the critical interactions between a tumor and its surroundings. Our platform supports long-term survival and proliferation of malignant and non-malignant cellular components of tissues. This includes tumor cells, stroma, and immune components. Anticancer cancer compounds tested in our models exhibit high correlation with clinical response when comparing treatment outcomes in the clinic with cellular behavior in response to the therapeutic regimen. Our organ-specific technology is compatible with multiple drug classes, including small molecules, antibodies, antibody-drug conjugates, immunomodulatory agents, CAR-T cells, etc. Our platform is fully customizable to the tumor and tissue of interest. It is compatible with multiple cell types, drug classes, and downstream analysis methods. Applications include providing efficacy screening of anticancer compounds, evaluation of mechanisms of drug resistance, identification of new drug combinations, rescue of failed drug candidates, assessment of off-target toxicity, target discovery and biomarker discovery. Soluble Biotech Our subsidiary, Soluble Biotech Inc. (“Soluble”), focuses on contract services and research for biopharmaceutical company clients and academic collaborators, focused on solubility improvements, stability studies, and protein production. Specifically, Soluble provides optimized FDA-approved formulations for vaccines, antibodies, and other protein therapeutics in a faster and lower cost basis to its customers. In addition, Soluble enables protein degradation studies, which is a new and, based on current projections, potentially substantial line of business for the Company. The primary assets of Soluble are our automated High Throughput Self-Interaction Chromatography (HSC™). HSC is a self-contained, automated system that conducts high-throughput, self-interaction chromatography screens on excipients previously approved by the FDA for protein formulations. Our technology measures second virial coefficient (B22 value) of protein-protein interactions to identify excipients that promote protein solubility in solutions. The data generated from HSC screens are analyzed by a proprietary predictive algorithm to identify the optimal combination(s) of buffers, pH, and excipients, resulting in increased solubility and physical stability of proteins. Several of our clients have seen ten-fold and hundred-fold increases in their protein’s solubility while maintaining physical stability. For biopharmaceutical clients this means faster development times and quicker progression of molecules into the clinic. For academic collaborators, this means further progression of biochemical & biology studies necessary to advance fundamental research in areas of unmet medical need. In addition, Soluble provides comprehensive protein stability analysis. Analysis via time-dependent shelf-life studies and forced degradation studies designed to quickly determine which of the previously FDA approved additives that will improve the solubility and stability of proteins in solutions. Services include pre-formulation development, stability assessment, and biophysical characterization which evaluate variables including pH, temperature, humidity, light, oxidizing agents, and mechanical stress to determine the most promising additives, formulation of B22 values and confirmation on conformation stability. We provide clients with a list of the most promising additives from a set of over 40 different additives that can increase the solubility and stability of protein formulations. Soluble also offers protein solubility kits that allow rapid identification of soluble formulations. We provide four different kits to fulfill customer solubility requirements. The kits are in 96-well format and provide the tools and methods to compare relative solubility across 88 common formulations (with 8 controls). Soluble kits utilize a simple mix and spin protocol that quickly evaluates aggregation behavior as a function of pH, salt, and additives costing significantly less than if manually determined. In addition, we provide innovative technologies for bacterial detection and removal in therapeutic proteins that continue to be a significant issue in the pharmaceutical field. In addition, Soluble supplies proprietary technologies for bacterial endotoxin detection and removal. Endotoxin is an inherent byproduct of bacterial expression of therapeutic proteins. However, therapeutic proteins are required to have extremely low endotoxin levels. Soluble provides a product to remove endotoxin that works through multiple molecular interactions for efficient removal over a wide range of buffer conditions with minimal product loss. The detection of endotoxin can also be adversely affected by the protein therapeutic itself. To address this, Soluble provides sample treatment kits to minimize detection interference while using standard detection assays. Skyline Medical – The STREAMWAY System
Sold through our subsidiary, Skyline Medical
Industry and Market Background and Analysis - Infectious and
There has long been recognition of the collective potential for ill effects to healthcare workers from exposure to infectious/
Most surgical procedures produce potentially infectious materials that must be disposed with the lowest possible risk of cross-contamination to healthcare workers. Current standards of care allow for these fluids to be retained in canisters and located in the operating room where they can be monitored throughout the surgical procedure. Once the procedure is complete these canisters and their contents are disposed using a variety of methods, all of which include manual handling and result in a heightened risk to healthcare workers for exposure to their contents. Canisters are the most prevalent means of collecting and disposing of infectious fluids in hospitals today. Traditional, non-powered canisters and related suction and fluid disposable products are exempt and do not require FDA clearance.
We believe that our virtually hands free direct-to-drain technology (1) significantly reduces the risk of healthcare worker exposure to these infectious fluids by replacing canisters, (2) further reduces the risk of worker exposure when compared to powered canister technology that requires transport to and from the operating room, (3) reduces the cost per procedure for handling these fluids, and (4) enhances the surgical team’s ability to collect data to accurately assess the patient’s status during and after procedures. In addition to the traditional canister method of waste fluid disposal, several other powered medical devices have been developed that address some of the deficiencies described above. Most of these competing products continue to utilize some variation on the existing canister technology, and while not directly addressing the canister, most have been successful in eliminating the need for an expensive gel and its associated handling and disposal costs. Our existing competitors with products already on the market have a clear competitive advantage over us in terms of brand recognition and market exposure. In addition, many of our competitors have extensive marketing and development budgets that could overpower an emerging growth company like ours.
We expect the hospital surgery market to continue to increase due to population growth, the aging of the population, and expansion of surgical procedures to new areas (for example, use of the endoscope) which requires more fluid management and new medical technology.
STREAMWAY System Product Sales
Our Skyline Medical division consists primarily of sales of the STREAMWAY System, as well as sales of the proprietary cleaning fluid and filters for use with the STREAMWAY System. We manufacture an environmentally conscious system for the collection and disposal of infectious fluids resulting from surgical and other medical procedures. We have been granted patents for the STREAMWAY System in the United States, Canada, and Europe. We distribute our products to medical facilities where bodily and irrigation fluids produced during medical procedures must be contained, measured, documented, and disposed. Our products minimize the exposure potential to the healthcare workers who handle such fluids.
The STREAMWAY System is a wall-mounted fully automated system that disposes of an unlimited amount of suction fluid providing uninterrupted performance for physicians while virtually eliminating healthcare workers’ exposure to potentially infectious fluids collected during surgical and other patient procedures.
TumorGenesis
Our subsidiary TumorGenesisis is our research and development arm for Helomics and zPREDICTA. TumorGenesis
On On May 18, 2022, we also completed a concurrent registered direct offering in which we issued and sold an aggregate of 8,162,720 shares of our common stock, at a purchase price of $0.60 per share (“Second Offering”). In connection with the Second Offering, we entered into a warrant amendment agreement (the “Warrant Amendment Agreement”) with each of the purchasers in the Second Offering. Under the Warrant Amendment Agreement, we agreed to amend certain existing warrants to purchase up to 16,325,435 shares of common stock that were previously issued in
We received aggregate net proceeds of approximately $6.5 million, after deducting placement agent fees and other offering expenses payable by us, from the First Offering and Second Offering.
Corporate Information
We were originally incorporated on April 23, 2002 and reincorporated in Delaware in 2013. We changed our name from Skyline Medical, Inc. to Precision Therapeutics, Inc. on February 1, 2018 and to Predictive Oncology Inc. on June 13, 2019.
Our address is 2915 Commers Drive, Suite 900, Eagan, Minnesota 55121. Our telephone number is (651) 389-4800, and our website address is www.predictive-oncology.com. The information contained on, or that can be accessed through, our website is not part of this prospectus.
OFFERING SUMMARY
10
RISK FACTORS
An investment in our securities involves a number of risks. Before deciding to invest in our securities, in addition to the risks and uncertainties discussed below under “Cautionary Note Regarding Forward-Looking Statements,” you should carefully consider the specific risks described
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
We discuss many of these and
You should read this prospectus, as well as the documents
USE OF PROCEEDS
We will not receive any proceeds from the sale of
DESCRIPTION OF CAPITAL STOCK
The following description summarizes the material terms of our capital stock. This summary is, however, subject to the provisions of our certificate of incorporation and bylaws. For greater detail about our capital stock, please refer to our certificate of incorporation and bylaws.
General
Our authorized capital stock consists of
Common Stock Voting Rights. The Dividend Rights. Subject to the dividend rights of the holders of any outstanding series of preferred stock, holders of our common stock are entitled to receive ratably such dividends and other distributions of cash or any other right or property as may be declared by our Board of Directors out of our assets or funds legally available for such dividends or distributions. Liquidation Rights. In the event of any voluntary or involuntary liquidation, dissolution or winding up of our affairs, holders of our common stock would be entitled to share ratably in our assets that are legally available for distribution to shareholders after payment of liabilities and after the satisfaction of any liquidation preference owed to the holders of any preferred stock. Conversion, Redemption and Preemptive Rights. Holders of our common stock have no conversion, redemption, preemptive, subscription or similar rights. Preferred Stock
Our Board of Directors is authorized, subject to any limitations prescribed by law, to provide for the issuance of the shares of
Anti-Takeover Provisions
Bylaws. Certain provisions of our Bylaws could have anti-takeover effects. These provisions are intended to enhance the likelihood of continuity and stability in the composition of our corporate policies formulated by our Board of Directors. In addition, these provisions also are intended to ensure that our Board of Directors will have sufficient time to act in what our Board of Directors believes to be in the best interests of our Company and our shareholders. Nevertheless, these provisions could delay or frustrate the removal of incumbent directors or the assumption of control of us by the holder of a large block of Common Stock, and could also discourage or make more difficult a merger, tender offer, or proxy contest, even if such event would be favorable to the interest of our shareholders. These provisions are summarized below. Advance Notice Provisions for Raising Business or Nominating Directors. Sections 2.09 and 2.10 of our Bylaws contain advance-notice provisions relating to the ability of shareholders to raise business at a shareholder meeting and make nominations for directors to serve on our Board of Directors. These advance-notice provisions generally require shareholders to raise business within a specified period of time prior to a meeting in order for the business to be properly brought before the meeting.
Number of Directors and Vacancies. Our Bylaws provide that the exact number of directors shall be determined from time to time solely by resolution adopted by the affirmative vote of a majority of the entire Board of Directors. The Board of Directors is divided into three classes, as nearly equal in number as possible, designated: Class I, Class II and Class III (each, a Delaware Law. We are subject to Section 203 of the Delaware General Corporation Law. This provision generally prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years following the date the stockholder became an interested stockholder, unless:
Section 203 defines a business combination to include:
In general, Section 203 defines an “interested stockholder” as any entity or person beneficially owning 15% or more of the outstanding voting stock of a corporation, or an affiliate or associate of the corporation and was the owner of 15% or more of the outstanding voting stock of a corporation at any time within three years prior to the time of determination of interested stockholder status; and any entity or person affiliated with or controlling or controlled by such entity or person.
These statutory provisions could delay or frustrate the removal of incumbent directors or a change in control of our company. They could also discourage, impede, or prevent a merger, tender offer, or proxy contest, even if such event would be favorable to the interests of stockholders. In addition, note that while Delaware law permits companies to opt out of its business combination statute, our Certificate of Incorporation does not include this opt-out provision.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is
Listing
The shares of our common stock are listed on The Nasdaq Capital Market under the symbol “POAI.”
SELLING STOCKHOLDERS
The selling
The selling The
The We do not know how long the selling Except as indicated by the footnotes below, we believe, based on the information furnished to us, that each of the selling stockholders has sole voting and investment power with respect to all shares of common stock that the selling stockholder
* Less than 1%
PLAN OF DISTRIBUTION We are registering the resale by the selling stockholders or their permitted transferees of up to 4,737,280 shares of common stock that are issuable upon the exercise of the Warrants. The selling stockholders will act independently of us in making decisions with respect to the timing, manner and size of each sale. We will pay all fees and expenses incident to the registration of the securities to be offered and sold pursuant to this prospectus. The selling stockholders will bear all commissions and discounts, if any, attributable to their sale of securities.
The selling
The selling
Broker-dealers engaged by the selling
In connection with the The selling stockholders and any broker-dealers or agents that are involved in selling the We agreed to keep this prospectus effective until no selling stockholder that was a purchaser in the
Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale of securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the selling
LEGAL MATTERS
The validity of any securities offered from time to time by this prospectus
EXPERTS
Baker Tilly US, LLP, our independent registered public accounting firm, has audited our consolidated financial statements
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the securities we are offering under this prospectus. This prospectus does not contain all of the information set forth in the registration statement and the exhibits to the registration statement. For further information with respect to us and the securities we are offering under this prospectus, we refer you to the registration statement and the exhibits and schedules filed as a part of the registration statement.
We file annual, quarterly and current reports, proxy statements and other information with the SEC. The SEC maintains a website that contains reports, proxy statements and other information regarding issuers that file electronically with the SEC, including us. The address of the SEC website is www.sec.gov.
We maintain a website at www.predictive-oncology.com. Information contained in, or accessible through, our website is not part of this prospectus and you should not rely on that information unless that information is also in this prospectus or incorporated by reference in this prospectus.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to “incorporate by reference” information into this prospectus, which means that we can disclose important information to you by referring you to another document filed separately with the SEC. The documents incorporated by reference into this prospectus contain important information that you should read about us. The following documents are incorporated by reference into this prospectus:
We are allowed to incorporate by reference information contained in documents that we file with the SEC. This means that we can disclose important information to you by referring you to those documents and that the information in this prospectus is not complete and you should read the information incorporated by reference for more detail. We incorporate by reference in two ways. First, we list certain documents that we have already filed with the SEC. The information in these documents is considered part of this prospectus. Second, the information in documents that we file in the future will update and supersede the current information in, and incorporated by reference in, this prospectus until we file a post-effective amendment that indicates the termination of the offering of the common stock made by this prospectus.
We incorporate by reference the documents listed below and any future filings we will make with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act (other than information furnished in Current Reports on Form 8-K filed under Item 2.02 or 7.01 of such form unless such form expressly provides to the contrary), including those made after the date of the initial filing of the registration statement of which this prospectus is a part and prior to effectiveness of such registration statement:
Our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed on March 31, 2022;
Our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed on May 12, 2022;
Our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 filed on August 11, 2022; Our Current Reports on Form 8-K filed on January 4, 2022, February 18, 2022, March 31, 2022, May 12, 2022, May 13, 2022, May 18, 2022, May 23, 2022, July 26, 2022, August 11, 2022, September 14, 2022 and September 16, 2022; Our Current Report on Form 8-K/A filed on February 10, 2022; and The description of the Company’s common stock under the caption “Description of Predictive Capital Stock – Common Stock” in the Company’s Amendment No 2 to Registration Statement on Form S-4 as filed with the SEC on January 24, 2019, as amended by the description filed as Exhibit 4.14 to the Company’s Annual Report on Form 10-K on March 31, 2022.
We will provide to each person, including any beneficial owner, to whom a prospectus is delivered, a copy of any or all of the information that has been incorporated by reference in this prospectus but not delivered with this prospectus. You may request a copy of this information at no cost, by writing or telephoning us at the following address or telephone number:
Predictive Oncology Inc. Attention: Corporate Secretary (651) 389-4800
PREDICTIVE ONCOLOGY INC.
4,737,280 Shares
Common Stock
______________________
PROSPECTUS
______________________
[•], , 2022
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item
The following table sets forth the costs and expenses, payable by the registrant in connection with the sale of common stock being registered. All amounts are estimates except the SEC registration fee and the Nasdaq listing fee.
Item
We are a Delaware corporation and certain provisions of the Delaware Statutes and our bylaws provide for indemnification of our officers and directors against liabilities that they may incur in such capacities. A summary of the circumstances in which indemnification is provided is discussed below, but this description is qualified in its entirety by reference to our bylaws and to the statutory provisions.
Section 145 of the Delaware General Corporation Law provides for, under certain circumstances, the indemnification of our officers, directors, employees and agents against liabilities that they may incur in such capacities. A summary of the circumstances in which such indemnification provided for is contained herein, but that description is qualified in its entirety by reference to the relevant Section of the Delaware General Corporation Law.
In general, the statute provides that any director, officer, employee or agent of a corporation may be indemnified against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement, actually and reasonably incurred in a proceeding (including any civil, criminal, administrative or investigative proceeding) to which the individual was a party by reason of such status. Such indemnity may be provided if the indemnified person’s actions resulting in the liabilities: (i) were taken in good faith; (ii) were reasonably believed to have been in or not opposed to our best interest; and (iii) with respect to any criminal action, such person had no reasonable cause to believe the actions were unlawful. Unless ordered by a court, indemnification generally may be awarded only after a determination of independent members of the Board of Directors or a committee thereof, by independent legal counsel or by vote of the stockholders that the applicable standard of conduct was met by the individual to be indemnified.
The statutory provisions further provide that to the extent a director, officer, employee or agent is wholly successful on the merits or otherwise in defense of any proceeding to which he was a party, he is entitled to receive indemnification against expenses, including attorneys’ fees, actually and reasonably incurred in connection with the proceeding.
Indemnification in connection with a proceeding by or in the right of the Company in which the director, officer, employee or agent is successful is permitted only with respect to expenses, including attorneys’ fees actually and reasonably incurred in connection with the defense. In such actions, the person to be indemnified must have acted in good faith, in a manner believed to have been in our best interest and must not have been adjudged liable to us unless and only to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability, in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expense which the Court of Chancery or such other court shall deem proper. Indemnification is otherwise prohibited in connection with a proceeding brought on behalf of the Company in which a director is adjudged liable to us, or in connection with any proceeding charging improper personal benefit to the director in which the director is adjudged liable for receipt of an improper personal benefit.
Delaware law authorizes us to reimburse or pay reasonable expenses incurred by a director, officer, employee or agent in connection with a proceeding in advance of a final disposition of the matter. Such advances of expenses are permitted if the person furnishes to us a written agreement to repay such advances if it is determined that he is not entitled to be indemnified by us.
The statutory section cited above further specifies that any provisions for indemnification of or advances for expenses does not exclude other rights under our certificate of incorporation, corporate bylaws, resolutions of our stockholders or disinterested directors, or otherwise. These indemnification provisions continue for a person who has ceased to be a director, officer, employee or agent of the corporation and inure to the benefit of the heirs, executors and administrators of such persons.
The statutory provision cited above also grants the power to the Company to purchase and maintain insurance policies that protect any director, officer, employee or agent against any liability asserted against or incurred by him in such capacity arising out of his status as such. Such policies may provide for indemnification whether or not the corporation would otherwise have the power to provide for it.
Article 8 of our certificate of incorporation provides that we shall indemnify our directors and officers to the fullest extent permitted by the Delaware General Corporation Law.
We have purchased directors’ and officers’ liability insurance in order to limit the exposure to liability for indemnification of directors and officers, including liabilities under the Securities Act of 1933.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted for our directors, officers, and controlling persons pursuant to the foregoing provisions or otherwise, we have been advised that in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. Item 15. Recent Sales of Unregistered Securities. The Registrant has issued the following securities that were not registered under the Securities Act with the past three years: (1) In June through September 2019, we issued and sold to certain accredited investors 258 shares of Series E convertible preferred stock at a purchase price of $10,000 per share, pursuant to a securities purchase agreement. We agreed to pay to Dawson James Securities, Inc., as placement agent, a commission of 8% of the gross proceeds raised from the sale of the Series E convertible preferred stock and warrants to purchase our common stock on a cashless basis based on 5% warrant coverage on the Series E convertible preferred stock sold in the offering. We also agreed to reimburse the placement agent for legal fees equal to $25,000 plus $4,000 per closing, plus other reasonable out-of-pocket expenses not to exceed $5,000. The Series E convertible preferred stock and the warrants were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and Rule 506 promulgated thereunder. (2) On September 27, 2019, we issued to Oasis Capital, LLC (i) a secured promissory note in the original principal amount of $847,500 that accrues interest at a rate of 8% per annum (with six months of interest guaranteed) and that matures six months from September 27, 2019 (“Oasis Note”), and (ii) an aggregate of 8,857 shares of our common stock plus a warrant to acquire up to 68,237 shares of the our common stock at an exercise price of $6.21 per share, in exchange for a cash investment of $700,000, pursuant to a securities purchase agreement. The issuance of the forgoing securities was not registered under the Securities Act in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. II-2 (3) On September 27, 2019, we issued 15,000 shares of common stock to L2 Capital, LLC pursuant to an amendment to the Amended and Restated Senior Secured Promissory Note dated September 28, 2018 and amended restated as of February 7, 2019 (“L2 Note”), under which, among other things, L2 Capital, LLC waived its rights under the L2 Note to have the L2 Note repaid from the proceeds of any financing consummated by us. The shares of common stock were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (4) On October 24, 2019, we issued to Oasis Capital, LLC 104,651 shares of our common stock having an aggregate market value of $450,000, as consideration for its commitment to purchase shares of our common stock having an aggregate value of up to $15.0 million over a period of three years, pursuant to that certain Equity Purchase Agreement dated October 24, 2019. The shares of common stock were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (5) On November 12, 2019, we issued 10,356 shares of common stock valued at $34,923 in payment for investor relations services. The shares of common stock were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (6) On December 12, 2019, we issued 15,000 shares of common stock to L2 Capital, LLC pursuant to a second amendment to the L2 Note, under which, among other things, L2 Capital, LLC waived its rights under the L2 Note to have the L2 Note repaid from the proceeds of any financing consummated by us. The shares of common stock were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (7) On January 31, 2020, we issued to Dr. Carl Schwartz, our CEO and director at that time, (i) a promissory note in the original principal amount of $2,115,000 that bears interest at 12% per annum and matures on September 30, 2020 (“Schwartz Note”) and (ii) 50,000 shares of our common stock, in exchange for, among other things, cancellation by Dr. Schwartz of two existing promissory notes with a total outstanding amount of $1,935,000 and warrants to purchase up to an aggregate of 97,313 shares of our common stock at exercise prices ranging from $7.04 to $11.88 per share, pursuant to an Exchange Agreement dated January 31, 2020. The issuance of the forgoing securities was not registered under the Securities Act in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (8) On February 5, 2020, we issued to Oasis Capital, LLC (i) a secured convertible promissory note in the aggregate principal amount of $1,450,000 that accrues interest at a rate of 8% per annum (with six months of interest guaranteed) and matures six months after February 5, 2020, (ii) five-year warrants to purchase up to an aggregate of 280,031 shares of our common stock at an exercise price equal to $2.992 per share and (iii) 46,875 shares of our common stock, in exchange for a cash investment of $1,200,000 pursuant to a securities purchase agreement dated as of February 5, 2020. The issuance of the forgoing securities was not registered under the Securities Act in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. II-3 (9) On March 19, 2020, pursuant to securities purchase agreement with certain accredited investors, we issued, for aggregate gross proceeds of approximately $3,500,000, (i) an aggregate of 260,000 shares of our common stock; (ii) prefunded warrants to purchase 1,390,166 shares of our common stock at an exercise price of $0.001 per share; (iii) Series A warrants to purchase an aggregate of 1,650,166 shares of our common stock at an exercise price of $1.88 per share; and (iv) Series B warrants to purchase 1,650,166 shares of our common stock at an exercise price of $1.88 per share. Pursuant to a letter agreement dated March 15, 2020, we paid to H.C. Wainwright & Co, LLC (“Wainwright”), which acted as placement agent for the offering, an aggregate fee equal to 7.5% of the aggregate gross proceeds received by us in the offering, a management fee equal to 1% of the aggregate gross proceeds received by us in the offering, $25,000 in non-accountable expenses and up to $40,000 in legal and other out-of-pocket expenses. We also issued to the placement agent warrants to purchase up to 123,762 shares of our common stock at an exercise of $2.65125 (equal to 125% of the offering price). The issuance of the forgoing securities was not registered under the Securities Act in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and Rule 506 promulgated thereunder. (10) On March 19, 2020, we issued 30,000 shares of our common stock to Oasis Capital, LLC pursuant to an amendment to the Oasis Note, under which, among other things, Oasis Capital, LLC waived its rights to have the Oasis Note repaid from the proceeds of any financing consummated by us. The shares of common stock were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (11) On April 21, 2020, we issued to Dr. Carl Schwartz, our CEO and director at that time, 1,533,481 shares of our common stock in exchange for cancellation of the Schwartz Note having a total outstanding balance of $2,192,878 in principal and accrued interest, pursuant to an exchange agreement dated April 21, 2020. The shares of common stock were issued pursuant to an exemption from registration contained in Section 3(a)(9) of the Securities Act. (12) On March 3, 2020, Peter Morawetz, a former Board member, was given 5,000 shares of common stock, valued at $9,800. On March 4, 2020, we issued 150,000 shares of common stock at $2.35 per share in payment for public relations services. The shares of common stock were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (13) On May 27, 2020, we issued 125,000 shares of our common stock to InventaBioTech, Inc. (“IBT”) and its designees pursuant to an asset purchase agreement in exchange for substantially all of the assets owned by and used or useful in the business of certain subsidiaries of IBT. The shares of common stock were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (14) On June 25, 2020, we issued warrants to purchase up to an aggregate of 1,396,826 shares of our common stock at an exercise price of $1.80 per share to certain accredited institutional investors holding outstanding warrants to purchase our common stock that were issued on May 8, 2020 (“May 2020 Warrants”). Such investors agreed to exercise their May 2020 Warrants in cash at an exercise price of $1.45 per share plus pay an additional $0.125 for each new warrant, pursuant to a warrant exercise letter agreement. We received approximately $2,200,000 in gross proceeds before deducting placement agent fees and offering expenses payable by us. Pursuant to an engagement letter dated May 6, 2020, we paid to Wainwright, who acted as placement agent, a cash fee equal to 7.5% of the gross proceeds received from the exercise and the sale of the warrants, a management fee equal to 1% of the aggregate gross aggregate gross proceeds received by us in the offering, $25,000 in non-accountable expenses and up to $40,000 in legal and other out-of-pocket expenses. In addition, we issued to the placement agent or its designees warrants to purchase up to an aggregate of 104,763 shares of our common stock at an exercise price of $2.25 per share (equal to 125% of the exercise price of the new warrants). II-4 The warrants were issued pursuant to exemptions from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (15) On July 1, 2020, we issued 954,719 shares of our common stock to Quantitative Medicine LLC (“QM”) and its designees pursuant to an asset purchase agreement in exchange for substantially all of the assets owned by QM. The shares of common stock were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (16) On January 12, 2021 we issued and sold to certain institutional and accredited investors in a registered direct offering an aggregate of 3,655,840 shares of our common stock, at a purchase price of $0.842 per share, for gross proceeds of approximately $3,000,000 before deducting placement agent fees and offering expenses payable by us. In a concurrent private placement, we also issued to such investors warrants to purchase up to an aggregate of 1,825,420 shares of our common stock at an exercise price of $0.80 per share. As partial compensation for Wainwright’s services as placement agent in the registered direct offering, we issued to Wainwright’s designees warrants to purchase up to 273,813 shares of our common stock at an exercise price of $1.0525 per share (equal to 125% of the offering price per share). The warrants issued to the investors and placement agent’s designees were issued pursuant to exemptions from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (17) On January 21, 2021 we issued and sold to certain institutional and accredited investors in a registered direct offering an aggregate of 2,200,000 shares of our common stock, at a purchase price of $1.00 per share, for gross proceeds of $2,200,000 before deducting placement agent fees and offering expenses payable by us. In a concurrent private placement, we also issued to such investors warrants to purchase up to an aggregate of 1,100,000 shares of our common stock at an exercise price of $1.00 per share. As partial compensation for Wainwright’s services as placement agent in the registered direct offering, we issued to Wainwright’s designees warrants to purchase up to 165,000 shares of our common stock at an exercise price of $1.25 per share (equal to 125% of the offering price per share). The warrants issued to the investors and placement agent’s designees were issued pursuant to exemptions from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (18) On January 26, 2021 we issued and sold to certain institutional and accredited investors in a registered direct offering an aggregate of 3,414,970 shares of our common stock, at a purchase price of $1.20 per share, for gross proceeds of approximately $4,000,000 before deducting placement agent fees and offering expenses payable by us. In a concurrent private placement, we also issued to such investors warrants to purchase up to an aggregate of 1,707,485 shares of our common stock at an exercise price of $1.37 per share. As partial compensation for Wainwright’s services as placement agent in the registered direct offering, we issued to Wainwright’s designees warrants to purchase up to 256,123 shares of our common stock at an exercise price of $1.50 per share (equal to 125% of the offering price per share). The warrants issued to the investors and placement agent’s designees were issued pursuant to exemptions from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (19) On February 16, 2021 we issued and sold to certain institutional and accredited investors in a registered direct offering an aggregate of 4,222,288 shares of our common stock, at a purchase price of $1.75 per share, for gross proceeds of approximately $7,400,000 before deducting placement agent fees and offering expenses payable by us. In a concurrent private placement, we also issued to such investors warrants to purchase up to an aggregate of 2,111,144 shares of our common stock at an exercise price of $2.00 per share. As partial compensation for Wainwright’s services as placement agent in the registered direct offering, we issued to Wainwright’s designees warrants to purchase up to 316,672 shares of our common stock at an exercise price of $2.1875 per share (equal to 125% of the offering price per share). II-5 The warrants issued to the investors and placement agent’s designees were issued pursuant to exemptions from registration contained in Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (20) On April 16, 2021, we issued 8,814 shares of common stock for payment of $10,400 for professional research services. On August 30, 2021, we issued 4,505 shares of common stock for payment of $5,000 for professional research services. On October 11, 2021, we issued 3,760 shares of common stock for payment of $5,000 for professional research services. The issuances of the forgoing shares of common stock were not registered under the Securities Act in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. (21) In February 23, 2022, we entered into a securities purchase agreement with certain accredited investors, pursuant to which we issued and sold an aggregate of 9,043,766 shares of our common stock, together with warrants to purchase 4,521,883 shares of our common stock at an exercise price of $2.00 per share. Each share of common stock accompanying warrant to purchase one-half share were sold together at a combined offering price of $1.95. We received approximately $17,600,000 in gross proceeds before deducting placement agent fees and offering expenses payable by us. Pursuant to an engagement letter dated May 6, 2020, we paid to Wainwright, who acted as placement agent, a cash fee equal to 7.5% of the gross proceeds received in the offering, a management fee equal to 1% of the aggregate gross proceeds received by us in the offering, $65,000 in non-accountable and legal expenses, and $15,950 for clearing fees. In addition, we issued to Wainwright or its designees warrants to purchase up to an aggregate of 678,282 shares of our common stock at an exercise price of $2.4375 per share (equal to 125% of the offering price). The shares of common stock and warrants were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and Rule 506 promulgated thereunder. (22) During the six months ended June, 30 2022, we issued an aggregate of 29,346 shares of common stock for an aggregate payment of $25,000 for professional research services. The shares of common stock were issued pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act and Rule 506 promulgated thereunder. (23) On May 18, 2022 we issued and sold to certain institutional and accredited investors in a registered direct offering an aggregate of 3,837,280 shares of our common stock, at a purchase price of $0.60 per share, for gross proceeds of approximately $2,300,000 before deducting placement agent fees and offering expenses payable by us. In a concurrent private placement, we also issued to such investors the May 2022 Warrants to purchase up to an aggregate of 3,837,280 shares of our common stock at an exercise price of $0.70 per share. As partial compensation for Wainwright’s services as placement agent in the registered direct offering and a concurrent registered direct offering of 8,162,720 shares of our common stock, we issued to Wainwright’s designees Placement Agent Warrants to purchase up to an aggregate of 900,000 shares of our common stock at an exercise price of $0.75 per share (equal to 125% of the offering price per share). The May 2022 Warrants and Placement Agent Warrants were issued pursuant to exemptions from registration contained in Section 4(a)(2) of the Securities Act and Rule 506 promulgated thereunder. II-6
Item 16. Exhibits.
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*Filed herewith. **Compensatory Plan or arrangement required to
Item 17. Undertakings.
The undersigned registrant hereby undertakes:
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provided, however, that: Paragraphs (a)(1)(i), (a)(1)(ii), and (a)(1)(iii) of this section do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of the Exchange Act that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Eagan, State of Minnesota, on
Each person whose signature appears below hereby constitutes and appoints
Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed below by the following persons in the capacities and on the dates indicated:
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