Delaware | | | 2834 | | | 98-0443284 | | |
| (State or other jurisdiction of incorporation or organization) | | | (Primary Standard Industrial Classification Code Number) | | | (I.R.S. Employer Identification No.) | |
271 Waverley Oaks Road,1371 East 2100 South, Suite 108, Waltham, MA 02452200, Salt Lake City, Utah 84105
(781) 788-9043
Stephen From
President and Chief Executive OfficerEyeGateKiora Pharmaceuticals, Inc.271 Waverley Oaks Road,1371 East 2100 South, Suite 108, Waltham, MA 02452200, Salt Lake City, Utah 84105
(781) 788-9043
Robert A. Petitt, Esq. Burns & Levinson LLP 125 Boston, MA 02110 (617) 345-3000 | | Michael Nertney, Esq. New York, New York (212) | |
Approximate date of commencement of proposed sale to the public
: As soon as practicable after the effective date of this registration statement.☒
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Large Accelerated filer ☐ | | | Accelerated filer ☐ | |
| Non-accelerated filer ☒ | | | Smaller reporting company ☒ |
Emerging growth company ☐ | |
Title of each Class of Securities to be Registered | Proposed Maximum Aggregate Offering Price(1) | Amount of Registration Fee | ||||||
Common Stock(2) | $ | 11,500,000 | $ | 1,333 |
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, as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to Section 8(a), may determine.
For each share of common stock underlying a share of Series E Preferred Stock that we sell, the number of shares of common stock that we are selling will be decreased on a one-for-one basis.
We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012 and, as such, we have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings. See “Prospectus Summary — Implications of Being an Emerging Growth Company.”
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Proceeds, before expenses, to us | | | | $ | | | | | $ | | | |
Prospectus dated2022.
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The EyeGate Ocular Bandage Gelsurface.
Hyaluronic acid is a naturally occurring polymer that is important in many physiological processes, including wound healing, tissue homeostasis, and joint lubrication. To create this hydrogel, the HA is modified to create CMHA that is then crosslinked together through the thiol groups to CMHA-S. Some products employ disulfide crosslinking while others utilize a Polyethylene Glycol Diacrylate, or PEGDA, crosslinker. Crosslinking slows degradation of the HA backbone and provides a matrix for incorporating therapeutic agents. Variations in the number of thiols per molecule, the molecular weight of the polymer, the concentration of the polymer, the type of crosslinking, and incorporation of active ingredients, provides a highly versatile platform that can be tailored to a specific application and formulated as eye drops, gels, or films.
Our first CMHA-S-based product candidate, the EyeGate OBG, is a topically applied 0.75% CMHA-S eye drop formulation that has completed its first-in-man clinical trial. Preclinical studies suggest that the specific CMHA-S chemical modification comprising the EyeGate OBG creates a favorable set of attributes, including prolonged retention time on the ocular surface, and a smooth continuous clear barrier without blur that can minimize mechanical lid friction, reduce repeat injury, and mechanically protect the ocular surface, allowing accelerated corneal re-epithelization. It is intended for the management of corneal epithelial defects and to accelerate re-epithelization of the ocular surface following surgery, infections, and other traumatic and non-traumatic conditions.
EyeGate OBG is being developed pursuant to ade novo 510(k) regulatory pathway for devices submitted for marketing clearance to the U.S. Food and Drug Administration, or FDA. We believe that EyeGate OBG is the first and only eye drop being developedDecember 2019, about 93,700 people in the U.S. to target acceleration of corneal re-epithelization. We anticipate initiatinghave RP. With a second trialworldwide population presently estimated at over 7.05 billion, it can be estimated that approximately 2 million people around the world have RP. Multiple products in development for RP have received Orphan Drug Designation in the second quarterU.S., including KIO-301, as described further below.
The same crosslinked HA in EyeGate OBG is presently available commercially as a veterinary device indicated for use in the management of superficial noninfectious corneal ulcers. Manufactured by SentrX Animal Care and sold in the U.S. by Bayer Animal Health as Remend® Corneal Repair, the product has been used successfully for five years in dogs, cats and horses, without adverse effects. The composition of the veterinary product is identical to that of the EyeGate OBG. We have obtained a license from BioTime, Inc. for the exclusive worldwide right to commercialize CMHA-S for ophthalmic treatments in humans. We paid BioTime $50,000, and are required to pay royalties to BioTime based on revenue relating to any product incorporating the CMHA-S technology. Our license agreement expires when patent protection for the CMHA-S technology lapses, which is expected to occur in the U.S. in 2027. We
Our first product candidate from our second platformproliferating cells, such as the expansion of activated B and T-cells, cancer cells, and pathogen infected host cells, is EGP-437,the requirement of an abundance of nucleotide bases. These metabolic activities will predominately utilize the de novo pathway for nucleotide biosynthesis. A key advantage of DHODH inhibition is the selectivity towards metabolically activated cells (with a reformulated topically active corticosteroid, dexamethasone phosphate, delivered into the ocular tissues through our proprietary innovative iontophoresis drug delivery system, the EyeGate® II Delivery System. The EyeGate® II Delivery System features a compacthigh need for RNA and easy-to-use device that we believe has the potential to deliver drugs non-invasively and quickly into the ocular tissuesDNA production), which should mitigate any negative impact on normal cells. Depletion of cellular pyrimidine pools through the useselective inhibition of iontophoresis, which can accelerate the onset of action, dramatically reduce dosing frequency comparedDHODH has been shown to regular eye drops, and sustain the duration ofbe a successful approach for therapeutic effect. Iontophoresis employs the use of a low electrical current that promotes the migration of a charged drug substance across biological membranes. The EyeGate® II Delivery System is easy-to-use, taking only a few minutes to deliver medication. More than 2,400 treatmentsdevelopment.
EGP-437 is being developed pursuant to a new drug application, or NDA, under the Section 505(b)(2) pathway, which enables an applicant to rely, in part, on the FDA’s findings of safety and efficacy for an existing product, or published literature, in support of its NDA. In the case of EGP-437, the existing reference product is dexamethasone eye drops. Based on guidance provided by the FDA, we believe that if the planned confirmatory Phase 3 trial of EGP-437 in anterior uveitis meets non-inferiority criteria, the results of that trial, along with data from our previously completed Phase 3 trial in anterior uveitis, will be sufficient to support a NDA filing in the first half of 2018. We also believe, based on guidance provided by the FDA, that the design of the ongoing confirmatory Phase 3 anterior uveitis trial is acceptable and that the nonclinical work completed to date is sufficient to support a NDA filing.
Medical products containing a combination of new drugs, biological products, or medical devices may be regulated as “combination products” in the U.S. A combination product generally is defined as a product comprised of components from two or more regulatory categories, such as drug/device, device/biologic, or drug/biologic. Each component of a combination product is subjecttrauma to the requirements established by the FDA for that type of component, whether a new drug, biologic, or device. In ordercornea. PCEDs require intervention as they can lead to facilitate premarket review of combination products, the FDA designates one of its centers to have primary jurisdiction for the premarket reviewinfections, stromal ulceration, corneal scarring, and regulation of both components. We expect that the Center for Drug Evaluationopacification and Research will have primary jurisdiction over our EGP-437 combination product. The determination whether a product is a combination product or two separate products is made by the FDA on a case-by-case basis. We have had discussions with the FDA about the status of our EGP-437 combination product as a combination product and we have been advised that the FDA considers our product a combination drug/device.
We have entered into two exclusive global license agreements with subsidiaries of Valeant Pharmaceuticals International, Inc. (“Valeant”), through which we have granted Valeant exclusive, worldwide commercial and manufacturing rights to the combination of our EyeGate® II Delivery System and our EGP-437 product
Ophthalmology is a specialty market with commercial and regulatory dynamics that we believe make it possible for a small or medium sized company like us to develop and commercialize products on our own. We believe that the specialists in the U.S. who treat ocular diseasesdefect.
EyeGate OBG is initially targetingsurface that have long recovery, whereby acceleration of that period would benefit the accelerated re-epithelization of large corneal epithelial defects resulting from PRK.
PRKpatients. Photorefractive keratectomy (“PRK”) surgery is an efficacious alternative to patients seeking surgical correction of refractive errors who are not suitable candidates for laser in situ keratomileusis (“LASIK”)LASIK due to inadequate corneal thickness, larger pupil size, history of keratoconjunctivitis sicca (“KCS”),KCS, or anterior basement membrane disease. PRK surgery involves controlled mechanical removal of corneal epithelium with subsequent excimer laser photoablation of the underlying Bowman’s layer and anterior stroma, including the subepithelial nerve plexus.
risk of corneal infection prior to re-epithelization of the large epithelial defect, corneal haze formation, decreased contrast sensitivity, and slower visual recovery.
Per The number of laser vision correction procedures is on the rise, estimated in 2021 at over 2.1 million in the USA, according to the literature. Whilst PRK comprises a fraction of these procedures, there are about 160,000 surgeries performed annually in the USA. These surgeries are heavily consolidated to a few corporate umbrellas, such as TLC Laser Eye Centers, enabling a targeted commercial campaign once a therapeutic is approved.
Large corneal epithelial defects can result from various etiologies such as ocular trauma, surgery, ocular surface disorders, systemic diseases, and epithelial injury due to exposure. We believe EyeGate OBG has the potential to treat a wide variety of ocular diseases and disorders that result from corneal epitheliopathy, and based on statistics from the National Eye Instituteprimary objective of the National Institutesstudy was to assess the safety and tolerability of Health,ascending doses of KIO-101 in patients. The secondary objectives were to assess improvement of intraocular inflammation and to evaluate the Centerspharmacokinetics of KIO-101 in patients. For this study, KIO-101 was formulated as a sterile, aqueous solution for Disease Control,intravitreal injection.
In January 2017, we reported positive topline results from the first-in-human pilotour corneal wound repair pivotal clinical trial of EyeGate OBG,KIO-201 for the acceleration ofcorneal re-epithelialization of large corneal epithelial defects in patients having undergone PRK. PRK surgery. As shown below, this pivotal study demonstrated that KIO-201 accelerates corneal wound healing versus standard of care in post PRK surgical recovery.
an independent masked reading center, using digital slit-lamp photographs of fluorescein staining in all treated eyes, and a protocol-driven method to quantify the outcomes.
The study demonstrated safety and tolerability of EyeGate OBG, with encouraging potential efficacy. 83.3%
# Subjects per arm | Closed Wound: Day 3 | Surface Area (mm2) | ||||||||||||||||||
# | % | Day 1 | Day 3 | |||||||||||||||||
Arm 1: OBG | 12 | 10 | 83.3 | % | 18.5 | 0.02 | ||||||||||||||
Arm 2: OBG + BCL | 14 | 9 | 64.3 | % | 40.7 | 0.10 | ||||||||||||||
Arm 3: BCL + AT1 | 13 | 7 | 53.8 | % | 39.5 | 0.37 | ||||||||||||||
Total Subjects Enrolled | 39 | |||||||||||||||||||
OBG vs BCL: % Superior | 54.8 | % | 53.3 | % | 94.4 | % |
Delivery of therapeutic agents using ocular iontophoresis is a potential means of non-invasively achieving higher drug levels rapidly within the eye by promoting the migration of a charged drug substance across biological membranes with a low electrical current. The EyeGate® II Delivery System applicator utilizes an inert electrode, which stimulates the electrolysis of water to produce ions (hydroxide or hydronium), which via electrorepulsion, drive a like-charged drug substance into the ocular tissues. The EyeGate® II Delivery System is a platform technology that requires customized pharmaceutical formulations to enable delivery efficiency and safety while allowing for potential novel intellectual property.
Many frontcentral region of the eye conditions such as pain and inflammation following cataract surgery and non-infectious anterior uveitis are acute inflammatory conditions. The current standard of care to treat ocular surface and anterior segment inflammation is patient administered corticosteroidscornea in the form of eye drops. Topical corticosteroids suffer from a number of drawbacks including poor patient compliance, low ocular bioavailability, rapid clearance, and steroid-related side effects including elevated intraocular pressure (IOP). We believe that our EGP-437 product candidate has the potential to address these unmet needs by providing in-office treatments given by the eye care provider thereby mitigating patient compliance issues and substantially reducing the burden of care. Also, the data from multiple clinical trials suggests that EGP-437 does not significantly raise IOP, at the time points evaluated during the study period.
The primary route of administration for drugs treating retinal diseases is through intravitreal injection into the vitreous of the eye. These injections must be given as frequently as once per month when treating chronic diseases like macular degeneration. Unfortunately, there are known drawbacks associated with administering intravitreal injections, including safety risks, adverse patient experience and the time and labor to administer. Data from our Phase 1b/2a proof-of-concept trial in macular edema suggests that iontophoresis can non-invasively deliver efficacious levels of EGP-437 to the back of the eye and or retina. The non-invasive delivery of EGP-437both eyes. KIO-201 demonstrated a positive responsetreatment effect as compared to Refresh Plus at both Day 7 and Day 14. The overall improvement (i.e., reduction in some macular edema patientsstaining) at Day 14 was approximately 27% from baseline versus only approximately 9% for the positive control, Refresh Plus eye drops. KIO-201 also showed improvement more quickly than Refresh Plus eye drops with an approximately 10% reduction in staining versus an increase in staining of approximately 7% for the trial.
CataractsRefresh Plus treatment group.
inflammatory processesabroad relating to proprietary technologies that are inducedimportant to the development of our business. We also rely on, and will continue to rely on, trade secrets, know-how, continuing technological innovation and in-licensing opportunities to develop and maintain our proprietary position. We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications filed by phacoemulsification where the eye’s cloudy lens is emulsified with an ultrasonic hand piece and aspirated from the eye. Inflammation is induced in all cataract surgeries by the mechanical transmission of energy into the eye, disruption of cell membranes, and the normal healing process. Postoperative topical corticosteroids are used routinely to reduce inflammation and improve visual outcomes after cataract surgery. Despite their use, transient corneal edema is one of the major factors that can hinder the improvement of visionus in the first days after surgery,future, nor can we be sure that any of our existing patents or any patents that may be granted to us in the future will be commercially useful in protecting our technology.
Uveitis is a general term for inflammation of the uveal tract and encompasses a wide range of etiologies. It may be idiopathic, associated with systemic diseases or result from a variety of infectious agents. An annual estimated 17.6% of active uveitis patients experience transient or permanent loss of vision. Uveitis is responsible for more than 2.8% of cases of blindness in the U.S., making this disorder an important cause of vision loss and impairment. Non-infectious anterior uveitis is a debilitating form of intraocular inflammation of the anterior portion of the uvea, such as the iris and/or ciliary body and is the most common form of uveitis. Incidence in the U.S. ranges from approximately 26.6 to 102 per 100,000 adults annually with recent reports indicating occurrence in all age groups with the highest incidence in those over age 65. Chronic or recurrent, anterior uveitis may lead to complications such as cataracts, glaucoma, and macular edema.
Inflammation can be classified as either acute or chronic. Acute inflammation is the initial response of the body to harmful stimuli and is achieved by the increased movement of plasma and white blood cells from the blood into the injured tissues, in this case the uvea. Sometimes, the inflammation associated with anterior uveitis is in response to a real infection. This is known as infectious anterior uveitis. However, anterior uveitis often occurs for no apparent reason as the result of the immune system malfunctioning and triggering the process of inflammation even though no infection is present. This is known as non-infectious anterior uveitis. Patients that have anterior uveitis exhibit a large number of white blood cells in the anterior chamber of the eye. In order to count these cells in the anterior chamber, the physician uses a slit lamp, an instrument consisting of a high-intensity light source that can be focused to shine a thin sheet of light into the eye. The treatment objective is to eliminate the inflammation of the uvea which can be confirmed by an anterior chamber cell count of zero.
We submitted an IND for EGP-437 to the FDA in April 2008, under which we have completed seven clinical trials. The first two trials were executed in parallel — a Phase 1/2 non-infectious anterior uveitis trial and a Phase 2 dry eye trial. These two trials were followed by a Phase 3 dry eye trial. Subsequently, we completed our first Phase 3 trial for non-infectious anterior uveitis. During the timetechnologies that we executedconsider important to our business, our ability to defend our patents, and our ability to preserve the Phase 3 non-infectious anterior uveitis trial we completed a Phase 2 proof-of-concept cataract surgery trial, with prophylactic treatmentconfidentiality of EGP-437. In December 2016, we completed a Phase 1b/2a dose ranging trial treating inflammationour trade secrets and pain for subjects that have undergone cataract surgeryoperate our business without infringing the patents and in mid-2016 a Phase 1b/2a proof-of-concept macular edema trial, which demonstrated the abilityproprietary rights of the EyeGate® II Delivery Systemthird parties.
We have completed two trials (Phase 2 prophylacticKIO-101 as composition-of-matter, formulations thereof and Phase 1b/2a dose-ranging) andits therapeutic uses in December 2016 reported positive data for our Phase 1b/2a dose-ranging clinical trial for the treatment of ocular inflammationdisorders and pain in post-surgical cataract patients. The designdiseases and more. In addition, KIO-301 holds a patent portfolio consisting of this trial is basedplatform enabling IP, composition-of-matter, methods of use, and formulations thereof. These issued patents will expire between 2023 and 2036. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. In the future, we intend to apply for restorations of patent term for some of our currently owned or licensed patents to add patent life beyond their current expiration date, depending on treating the patients post-operativelyexpected length of clinical trials and not prophylactically. The Phase 1b/2a clinical trial was a multi-center, open-label trial enrolling 80 subjects who had undergone unilateral cataract extraction and implantation of a monofocal intra-ocular lens. The primary objective of this trial was to assess the safety and efficacy of iontophoretic EGP-437 in these patients following surgery. A positive response was achieved and the 4.5 mA-min iontophoretic dose has been determined as the optimal dose to take forward into a Phase 2 trial, to be initiatedother factors involved in the second quartersubmission of 2017, with the top-line data expectedrelevant new drug application or NDA. See “Government Regulation — Patent Term Restoration and Marketing Exclusivity” below.
Although we have completed two trials (Phase 2 and Phase 3) for dry eye, at this time we are not anticipating any further development for this indication. We have completed a Phase 1/2 for macular edema and at this time we are assessing the next steps for this indication.
Our goal is to become a leading specialty pharmaceutical company focused on developing and commercializing products for treating diseases and disorders of the eye. The key elements of this strategy are to:
As a company with less than $1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, enacted in April 2012. An “emerging growth company” may take advantagecommon stock.
We may take advantage of these provisions until December 31, 2020. However, if certain events occur prior to December 31, 2020, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.07 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company before such date.
We have elected to take advantage of certainstock split and of the reduced disclosure obligationsexercisability of the warrants, and may electwill expire on the five year anniversary of the initial exercise date. We do not have a sufficient number of authorized shares to take advantagepermit exercise of other reduced reporting requirements in future filings. As a result, the informationwarrants. In the event that we provideare unable to effect a reverse split in an amount sufficient to permit the exercise in full of the warrants or the shareholders do not approve the exercise of the warrants, the warrants will not be exercisable and therefore have no value. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the warrants.
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The final public offering price will be determined through negotiations between us and the underwriter in the offering and may be at a discount to the current market price. Therefore, the assumed public offering price used throughout this prospectus may not be indicative of the final public offering price. Furthermore, if the underwriter exercises its option to purchase additional shares of common stock and/or warrants, you will experience further dilution.
On April 12, 2017, we receivedstockholders’ approval of a noticereverse stock split in an amount sufficient to permit the exercise in full of the warrants, contingent upon stockholder approval of such
(“MVLS”) was less than $35 million,the warrants, if any, is uncertain and (iii) we did not have net income from continuing operations inthere can be no assurance that the latest fiscal year or in twomarket value of the last three fiscal years. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), we have a period of 180 calendar days,warrants will equal or until October 2, 2017, to regain compliance. To regain compliance, atexceed their imputed offering price. The warrants will not be listed or quoted for trading on any time duringmarket or exchange. There can be no assurance that the 180 calendar day-compliance period, our MVLS must be $35 million or more for a minimum of 10 consecutive business days or we must have stockholders’ equity of at least $2.5 million.
In the event that we do not regain compliance with these listing requirements prior to the expirationmarket price of the compliance period, wecommon stock will receive written notification that our securities are subject to delisting. At that time, we may appealever equal or exceed the delisting determination to a hearings panel pursuant to NASDAQ’s appeal procedures. We believe that the receiptexercise price of the net proceedswarrants, and consequently, whether it will ever be profitable for holders of this offering will bring us back into compliance with these listing requirements.
the warrants to exercise the warrants.
You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
The following table sets forth, for the periods indicated, the range of high and low sales prices of our common stock as reported by The NASDAQ Capital Market since July 31, 2015 and the high and low bid prices of our common stock quoted on the OTCQB prior to such date. OTCQB quotations reflect inter-dealer prices, without retail mark-up, mark-down or commissions, and may not represent actual transactions.
High | Low | |||||||
Fiscal Year Ending December 31, 2017 | ||||||||
Second quarter (through April 20, 2017) | $ | 2.53 | $ | 2.00 | ||||
First quarter | $ | 3.90 | $ | 1.42 | ||||
Fiscal Year Ended December 31, 2016 | ||||||||
Fourth quarter | $ | 2.10 | $ | 1.11 | ||||
Third quarter | $ | 3.00 | $ | 1.31 | ||||
Second quarter | $ | 4.00 | $ | 2.42 | ||||
First quarter | $ | 5.10 | $ | 1.38 | ||||
Fiscal Year Ended December 31, 2015 | ||||||||
Fourth Quarter | $ | 5.00 | $ | 2.39 | ||||
Third quarter | $ | 22.68 | $ | 2.78 | ||||
Second quarter | $ | 5.09 | $ | 3.22 | ||||
First quarter (from February 19, 2015) | $ | 6.10 | $ | 3.10 |
On April 20, 2017,15, 2022, the last reported sale price of our common stock as reported by The NASDAQNasdaq Capital Market was $2.11$0.2656 per share. As of such date, we had approximately 89145 stockholders of record.
excluding the proceeds, if any, from the exercise of the warrants issued pursuant to this offering.
Assumed public offering price per share | $ | |||||||
Net tangible book value (deficit) per share as of December 31, 2016 | $ | (0.0017 | ) | |||||
Increase in net tangible book value per share after giving effect to this offering | $ | |||||||
As adjusted net tangible book value per share after giving effect to this offering | $ | |||||||
Dilution per share to new investors | $ |
If the underwriter exercises in full its option to purchase additional shares of our common stock, at the assumed public offering price of $dilution on a per share the last reported sale pricebasis:
| Assumed public offering price per share of common stock and warrant | | | | | | | | | | $ | 0.2656 | | |
| Net tangible book value per share as of March 31, 2022 | | | | $ | 0.0379 | | | | | | | | |
| Increase in net tangible book value per share after giving effect to this offering | | | | $ | 0.1310 | | | | | | | | |
| As adjusted net tangible book value per share after giving effect to this offering | | | | | | | | | | $ | 0.1689 | | |
| Dilution per share to new investors | | | | | | | | | | $ | 0.0967 | | |
determined at pricing.
sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of our common stock, including through the sale of securities convertible into or exchangeable or exercisable for common stock, the issuance of these securities could result in further dilution to our stockholders, including investors purchasing our common stock in this offering.
Outstanding Shares.
company.
resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with respect to transactions not approved in advance by the board of directors.
General. Our certificate of incorporation authorizes our board of directors to issue up to 10,000,000 shares of our preferred stock, par value $0.01 per share.
Subject to the limitations prescribed by our certificate of incorporation, our board of directors is authorized to establish the number of shares constituting each series of preferred stock
The purpose of authorizing our Board to issue preferred stock in one or more series and determine the number of shares in the series and its rights and preferences is to eliminate delays associated with a shareholder vote on specific issuances. Examples of rights and preferences that the Board may fix are:
The existence of authorized but unissued shares of preferred stock may enable our Board to render more difficult or to discourage an attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise. For example, if in the due exercise of its fiduciary obligations, our Board were to determine that a takeover proposal is not in the best interests of us or our stockholders, our Board could cause shares of preferred stock to be issued without stockholder approval in one or more private offerings or other transactions that might dilute the voting or other rights of the proposed acquirer, stockholder or stockholder group. The rights of holders ofregistrar for our common stock described above, will be subject to, and may be adversely affected by, the rights of any preferred stock that we may designate and issue in the future. The issuance of shares of preferred stock could decrease the amount of earnings and assets available for distribution to holders of shares of common stock. The issuance may also adversely affect the rights and powers, including voting rights, of these holders and may have the effect of delaying, deterring or preventing a change in control of us.
We will incorporate by reference as an exhibit to the registration statement, which includes this prospectus, the form of any certificate of designations that describes the terms of the series of preferred stock we are offering. This description and the applicable prospectus supplement will include:
When we issue shares of preferred stock under this prospectus, the shares will fully be paid and nonassessable and will not have, or be subject to, any preemptive or similar rights.
Shares of our common stock are quoted on The NASDAQNasdaq Capital Market under the symbol “EYEG.“KPRX.”
In connection with our initial public offering in February 2015, we issued warrants to the underwriters for that offering that provide for certain registration rights to the holders thereof. Each of the warrants provide that the holder shall have certain rights to participate in registrations of our common stock that we may decide to do, from time to time.
| Number of Shares of Common Stock (or Common Stock underlying Series E Preferred Stock) | | | Number of Warrants | | ||
| | | | | | | |
Total | | | | | | | |
Subject to the terms and conditions set forth in
The underwriter is offering the shares, subject to prior sale, when, as and if issued to and accepted by it, subject to approval of legal matters by its counsel, including the validity of the shares, and other conditions contained in the underwriting agreement, such as the receipt by the underwriter of officer’s certificates and legal opinions. The underwriter reserves the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.
The following table shows the per share and total underwriting discount to be paid to the underwriter by us at the assumed public offering price set forth on the cover page of this prospectus. Such amounts are shown assuming both no exercise and full exercise of the underwriter’s option to purchase additional shares.
The underwriter has advised us that it proposes to offercommon stock directly to the public the shares purchased pursuant to the underwriting agreement at the public offering price set forth on the cover page of this prospectus andprospectus. Any securities sold by the underwriters to certain securities dealers will be sold at the public offering price less a selling concession not in excess of $ per share. Aftershare of common stock (or per share of common stock underlying Series E Preferred Stock) and $ per warrant to purchase common stock.
| | | Per Share and Warrant(1) | | | Total Without Over-Allotment | | | Total With Full Over-Allotment | | |||
Public offering price | | | | $ | | | | | | | | | |
Underwriting discounts and commissions to be paid to underwriters by us(2)(3) | | | | $ | | | | | | | | | |
Proceeds, before expenses, to us | | | | $ | | | | | | | | |
The expensesunderwriting discount corresponds, in respect of the securities (i) a public offering not includingprice per share of common stock (or per share of common stock underlying Series E Preferred Stock) of $ ($ net of the underwriting discount, are estimated atdiscount) and (ii) a public offering price per warrant of $ and are payable by us.
($ net of the underwriting discount).
a maximum of $80,000.
other securities are being offered.
These lock-up restrictions will not apply to: (1) bona fide gifts, sales or other dispositions made exclusively by the holder to the holder’s family, partners, members, stockholders or affiliates (as applicable),factors and transfers or other dispositions by will, other testamentary documents or intestate succession,providedwe cannot assure you that such transferee agrees to be bound by the terms of the lock-up agreement, the parties agree to not make any filing or public announcement regarding such transfer or disposition prior to the expiration of the lock-up period and the holder notifies the underwriter at least two business days prior to the proposed transfer or disposition; (2) the exercise of warrants or stock options granted pursuant to the Company’s stock option/incentive plans or otherwise, or the conversion of securities, in each case outstanding on the date of this prospectus,providedthat the restrictions shall apply to the shares of common stock issued upon such exercisesold in this offering can be resold at or conversion; (3)above the establishment of any trading plan established pursuant to Rule 10b5-1 under the Exchange Act,providedthat no sales or securities convertible into common stock shall be made pursuant to such plan prior to the expiration of the lock-up period, and the Company does not, and is not required to, report the establishment of such plan in any public report or filing with the SEC under the Exchange Act prior to the expiration of the lock-up period; (4) any forfeiture, sale or other transfer to the company in connection with the termination of the holder’s employment with or services to the company; and (5) the transfer of shares to the company to satisfy withholding taxes for any equity award granted prior to the date of this prospectus.
The underwriter may release the common stock and other securities subject to the lock-up agreements described above in whole or in part at any time. When determining whether or not to release common stock and other securities from lock-up agreements, the underwriter will consider, among other factors, the holder’s reasons for requesting the release, the number of shares of common stock and other securities for which the release is being requested and market conditions at the time.
We have agreed to indemnify the underwriter against certain liabilities, including liabilities under the Securities Act, and to contribute to payments that the underwriter may be required to make for these liabilities.
In connection with this offering, the underwriter and any selling group members may engage in passive market making transactions in our common stock on The NASDAQ Capital Market in accordance with Rule 103 of Regulation M under the Securities Exchange Act of 1934, as amended, during a period before the commencement of offers or sales of common stock and extending through the completion of the distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker’s bid, that bid must then be lowered when specified purchase limits are exceeded.
Our shares of common stock are listed on The NASDAQ Capital Market under the symbol “EYEG.”
In connection with the offering, the underwriter or certain securities dealers may distribute prospectuses by electronic means, such as e-mail.
The underwriter and its affiliates have provided in the past to us and our affiliates, and may provide from
In relation to each Member State of the European Economic Area which has implemented the Prospectus Directive (each, a “Relevant Member State”) an offer to the public of any securities which are the subject of the offering contemplated by this prospectus supplement and the related prospectus may not be made in that Relevant Member State except that an offer to the public in that Relevant Member State of any such securities may be made at any time under the following exemptions under the Prospectus Directive, if they have been implemented in that Relevant Member State:
For the purposes of this provision, the expression an “offer to the public” in relation to any of the securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any such securities to be offered so as to enable an investor to decide to purchase any such securities, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State and the expression “Prospectus Directive” means Directive 2003/71/EC and includes any relevant implementing measure in each Relevant Member State.
The underwriter has represented, warranted and agreed that:
In particular, this document does not constitute an approved prospectus in accordance with European Commission’s Regulation on Prospectuses no. 809/2004 and no such prospectus is to be prepared and approved in connection with this offering. Accordingly, in relation to each Member State of the European Economic Area which has implemented the Prospectus Directive (being the Directive of the European Parliament and of the Council 2003/71/EC and including any relevant implementing measure in each Relevant Member State) (each, a Relevant Member State), with effect from and including the date on which the Prospectus Directive is implemented in that Relevant Member State (the Relevant Implementation Date) an offer of securities to the public may not be made in that Relevant Member State prior to the publication of a prospectus in relation to such securities which has been approved by the competent authority in that Relevant Member State or, where appropriate, approved in another Relevant Member State and notified to the competent authority in that Relevant Member State, all in accordance with the Prospectus Directive, except that it may, with effect from and including the Relevant Implementation Date, make an offer of securities to the public in that Relevant Member State at any time:
For the purposes of this provision, the expression an “offer of securities to the public” in relation to any of the securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the securities to be offered so as to enable an investor to decide to purchase or subscribe for the securities, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State. For these purposes the shares offered hereby are “securities.”
EyeGate
Securities and Exchange Commission registration fee | $ | 1,333 | ||
Legal fees and expenses | * | |||
Accounting fees and expenses | * | |||
Transfer agent fees and expenses | * | |||
Miscellaneous | * | |||
Total | $ | * |
| Securities and Exchange Commission registration fee | | | | $ | 1,483.20 | | |
| FINRA Filing Fee | | | | | 2,900 | | |
| Legal fees and expenses | | | | | 75,000 | | |
| Accounting fees and expenses | | | | | 60,000 | | |
| Transfer agent fees and expenses | | | | | 3,000 | | |
| Printing expenses | | | | | 15,000 | | |
| Miscellaneous | | | | | 105,000 | | |
| Total | | | | $ | 262,383.20 | | |
II-1
The offer, sale, and issuance of the securities described in paragraphs (1), (2), (5), (6) and (7)this Item 15 were deemed to be exempt from registration under the Securities Act in reliance on Section 4(2)4(a)(2) of the Securities Act in that the issuances of the securities to the accredited investors didand Rule 506 promulgated under Regulation D promulgated thereunder as transactions by an issuer not involveinvolving a public offering. The recipients of the securities in each of these transactions acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were affixed to the securities issued in these transactions.
A list of exhibits filed with this registration statement on Form S-1 is set forth on
II-2
The undersignedcontrolling persons of the registrant hereby undertakes:
provided, however, that paragraphs (a)(l)(i), (a)(l)(ii) and (a)(l)(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 Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
II-4 EXHIBIT INDEX
II-5
II-6 * Previously filed. † Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission. †† Certain confidential portions of this exhibit were omitted because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed. # Management contract or compensatory plan or arrangement. II-7 SIGNATURES Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this Amendment No. 2 to Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of
KIORA PHARMACEUTICALS, INC.
Chief Executive Officer Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.
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