8-K
SOLIGENIX, INC. (SNGX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): May 3, 2023
Commission File No. 001-14778
Soligenix, Inc.
(Exact name of small business issuer as specified in its charter)
| DELAWARE | 41-1505029 |
|---|---|
| (State or other jurisdiction of <br>incorporation or organization) | (I.R.S. Employer <br>Identification Number) |
| 29 Emmons Drive ,<br><br>Suite B-10<br><br>Princeton , NJ | 08540 |
| (Address of principal executive offices) | (Zip Code) |
( 609 ) 538-8200
(Issuer’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $.001 per share | SNGX | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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Item 1.01 Entry into a Material Definitive Agreement.
On May 3, 2023, the Board of Directors (the “Board”) of Soligenix, Inc. (the “Company”) approved an amendment to the Company’s Director Compensation Policy (as amended, the “Compensation Policy”) to increase the number of shares of the Company’s common stock issuable upon exercise of the non-qualified stock option granted upon a director’s initial election or appointment to the Board.
Under the Compensation Policy, directors who are compensated as full-time employees receive no additional compensation for Board service. Each director who is not a full-time employee is paid $35,000 annually, on a prorated basis, for service on the Board; the chair of the Audit Committee is paid $15,000 annually, on a prorated basis; and the chairs of the Compensation Committee and the Nominating Committee are paid $10,000 annually, on a prorated basis. Additionally, Audit Committee members are paid $7,500 annually and Compensation Committee and Nominating Committee members are paid $5,000 annually. This compensation is paid quarterly.
The Compensation Policy provides for the directors who are not full-time employees to receive a fully vested non-qualified stock option to purchase 15,000 shares of the Company’s common stock upon initial election or appointment. Upon re-election to the Board, each director receives a non-qualified stock option to purchase up to $30,000 worth of the Company’s common stock, calculated using the closing price of the common stock on the date of grant, which options vest at the rate of 25% per quarter, commencing with the first quarter after each annual meeting of stockholders.
| Item 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
|---|
On May 3, 2023, the Board of Directors (the “Board”) of Soligenix, Inc. (the “Company”) increased the size of the Board from five to six members and appointed Timothy R. Coté, MD, MPH as a director, with an initial term expiring at the Company’s 2023 Annual Meeting of Stockholders. Committee appointments for Dr. Coté have not been determined.
Dr. Coté will receive compensation as provided in the Compensation Policy. Pursuant to the Compensation Policy, upon his appointment to the Board, the Company granted Dr. Coté a fully-vested non-qualified stock option under the Company’s 2015 Equity Incentive Plan to purchase up to 15,000 shares of the Company’s common stock at $1.42 per share (the closing price on the date of grant). Dr. Coté will receive annual cash compensation of $35,000 per year, additional annual cash compensation for committee service and additional equity compensation upon re-election to the Board, as described under Item 1.01 of this Current Report on Form 8-K.
Dr. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal service at the U.S. Food and Drug Administration (“FDA”), National Institutes of Health, and the Centers for Disease Control, Dr. Coté served as the Director of the FDA Office of Orphan Products Development from September 2007 to May 2011. In this role, he implemented the U.S. Orphan Drug Act and personally signed decisions on more than 1,400 orphan drug designation applications. After leaving FDA, Dr. Coté founded Coté Orphan, LLC (with a consultancy of 450 clients), where he served as Chief Executive Officer (“CEO”) until its sale in 2017 to IQVIA Holdings Inc. for $20 million. He is currently CEO of Only Orphans Cote LLC, a regulatory affairs consulting firm leveraging his expertise and commitment to delivering drugs for rare diseases. He also serves as the CEO of Silk Road Therapeutics, Inc., a privately held rare disease company from which the Company recently acquired an exclusive option to purchase a novel topical formulation of Pentoxifylline, a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient’s suffering from Behçet’s Disease.
On May 3, 2023, the Company issued a press release announcing the appointment of Dr. Coté to the Board. A copy of the press release is attached hereto as Exhibit 99.1.
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Item 9.01.Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
|---|---|---|
| 99.1 | | Press Release dated May 3, 2023 |
| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Soligenix, Inc. | ||
|---|---|---|
| | | |
| May 3, 2023 | By: | /s/ Christopher J. Schaber |
| Christopher J. Schaber, Ph.D. | ||
| | | President and Chief Executive Officer |
| | | (Principal Executive Officer) |
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EXHIBIT 99.1
Soligenix Announces Appointment of Timothy R. Coté, M.D.
to its Board of Directors
Strengthens regulatory and orphan drug development expertise
Princeton, NJ – May 3, 2023 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the appointment of Timothy R. Coté, M.D., M.P.H. to its Board of Directors.
Dr. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal service at the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), and the Centers for Disease Control (CDC), Dr. Coté served as the Director of the FDA Office of Orphan Products Development (OOPD) from September 2007 to May 2011. In this role, he implemented the U.S. Orphan Drug Act and personally signed decisions on more than 1,400 orphan drug designation applications. After leaving FDA, Dr. Coté founded Cote Orphan (with a consultancy of 450 clients), where he served as Chief Executive Officer (CEO) until its sale in 2017 to IQVIA for $20 million. He is currently CEO of Only Orphans Cote LLC, a regulatory affairs consulting firm leveraging his expertise and commitment to delivering drugs for rare diseases. He also serves as the CEO of Silk Road Therapeutics, a privately held rare disease company from which Soligenix recently acquired an exclusive option to purchase a novel topical formulation of Pentoxifylline (PTX), a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient’s suffering from Behçet’s Disease.
Dr. Coté received his bachelor's degree from Syracuse University, a medical doctorate from the Howard University College of Medicine and a master's degree in Public Health from Harvard School of Public Health. An anatomic pathologist and medical epidemiologist, he has published 80 peer-reviewed articles on areas as diverse as HIV/AIDS-related malignancies, typhoid fever epidemics, and the impact of bicycle helmet laws on injury statistics.
“I am eager to be joining the Soligenix Board of Directors at such an important time for the Company,” stated Dr. Coté. “Having spent over 20 years at the FDA, NIH, and CDC, I am confident that my experience will assist Soligenix in navigating the path forward for HyBryte™ and their other rare disease programs. I look forward to collaborating with the Board and management team to further this diverse pipeline.”
“We are pleased to welcome Dr. Coté to the Soligenix Board,” stated Christopher J. Schaber, PhD, President and CEO of Soligenix. “As Soligenix works with the FDA to advance its rare disease pipeline, including HyBryte™ (synthetic hypericin sodium) for the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer, where it successfully demonstrated statistically significant results in a Phase 3 clinical trial, we aim to leverage Dr. Coté’s extensive regulatory and orphan drug development expertise. We believe his knowledge will add significantly to our already experienced Board of Directors and management team.”
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. Development programs in this business segment also include expansion of synthetic hypericin sodium (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203).
Our Public Health Solutions business segment includes active development programs for RiVax^®^, our ricin toxin vaccine candidate, and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax^®^. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.
This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research
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and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in healthcare practice, third party reimbursement limitations and Federal and/or state healthcare reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful. Notwithstanding the result in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 1/2 proof-of-concept clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Further, there can be no assurance that RiVax^®^ will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax^®^. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. HyBryte™ potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this information. While the Company has determined this potential market size based on assumptions that its believes are reasonable, there are a number of factors that could cause expectations to change or not be realized. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
Company Contact:
Jonathan Guarino, CPA, CGMA
Senior Vice President and Chief Financial Officer
(609) 538-8200 | www.soligenix.com
Soligenix, Inc.
29 Emmons Drive, Suite B-10
Princeton, NJ 08540
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