0001558370-23-007396.txt : 20230501 0001558370-23-007396.hdr.sgml : 20230501 20230501074538 ACCESSION NUMBER: 0001558370-23-007396 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20230501 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230501 DATE AS OF CHANGE: 20230501 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SOLIGENIX, INC. CENTRAL INDEX KEY: 0000812796 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 411505029 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14778 FILM NUMBER: 23870054 BUSINESS ADDRESS: STREET 1: 29 EMMONS DRIVE STREET 2: SUITE B-10 CITY: PRINCETON STATE: NJ ZIP: 08540 BUSINESS PHONE: 609-538-8200 MAIL ADDRESS: STREET 1: 29 EMMONS DRIVE STREET 2: SUITE B-10 CITY: PRINCETON STATE: NJ ZIP: 08540 FORMER COMPANY: FORMER CONFORMED NAME: DOR BIOPHARMA INC DATE OF NAME CHANGE: 20020329 FORMER COMPANY: FORMER CONFORMED NAME: ENDOREX CORP DATE OF NAME CHANGE: 19960916 FORMER COMPANY: FORMER CONFORMED NAME: IMMUNOTHERAPEUTICS INC DATE OF NAME CHANGE: 19920703 8-K 1 sngx-20230501x8k.htm 8-K
0000812796falseDE00008127962023-05-012023-05-01

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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 1, 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
incorporation or organization)

 

(I.R.S. Employer
Identification Number)

 

 

 

29 Emmons Drive,

Suite B-10

Princeton, NJ

 

08540

(Address of principal executive offices)

 

(Zip Code)

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(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

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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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w

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Item 8.01. Other Events.

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On May 1, 2023, Soligenix, Inc. (the “Company”) issued a press release announcing that it has entered into an exclusive option agreement with Silk Road Therapeutics, Inc. a privately-held company. The option agreement grants the Company the right to acquire 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 (“BD”). BD is a rare multisystem inflammatory vasculitis with no cure, characterized by debilitating recurrent ulcers in the oral mucosa (95%), skin/genitalia (50%), and ocular compartment (15%). An orphan disease and area of unmet medical need affecting approximately 18,000 people in the United States (U.S.) and 80,000 in Europe, there are as many as 1,000,000 people worldwide living with this painful and life altering disease.  A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

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Safe Harbor for Forward-Looking Statements

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Certain statements contained in this report may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the 1934 Act. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “predicts,” “plans,” “expects,” “anticipates,” “believes,” “goal,” “target,” “estimate,” “potential,” “may,” “might,” “could,” “see,” “seek,” “forecast,” and similar words. Forward-looking statements are based on the Company’s current plans and expectations and involve risks and uncertainties which are, in many instances, beyond the Company’s control, and which could cause actual results to differ materially from those included in or contemplated or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks, uncertainties and factors detailed in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including in the Company’s Annual Report for the year ended December 31, 2022 on Form 10-K, which was filed with the SEC. As a result of such risks, uncertainties and factors, the Company’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this report as of the date hereof and assumes no obligations to update the information included in this report or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Item 9.01.Financial Statements and Exhibits.

 

(d)      Exhibits.

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Exhibit No.

 

Description

99.1

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Press Release dated May 1, 2023

104

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Cover Page Interactive Data File (embedded within the Inline XBRL document).

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SIGNATURE

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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.

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Soligenix, Inc. 

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May 1, 2023 

By:

/s/ Christopher J. Schaber 

 

 

Christopher J. Schaber, Ph.D.

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President and Chief Executive Officer

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(Principal Executive Officer)

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 EX-99.1 2 sngx-20230501xex99d1.htm EX-99.1

EXHIBIT 99.1

Graphic

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Soligenix Enters into Exclusive Option Agreement with Silk Road Therapeutics for Rights to Topical Pentoxifylline Designed to Treat Behçet’s Disease

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Phase 2/3-Ready Orphan Disease Program Complements

Company’s Existing Late-Stage Rare Disease Pipeline

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PRINCETON, NJ – May 1, 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, today announced that it has entered into an exclusive option agreement with Silk Road Therapeutics, a privately-held company. The option agreement grants the Company the right to acquire 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 (BD). BD is a rare multisystem inflammatory vasculitis with no cure, characterized by debilitating recurrent ulcers in the oral mucosa (95%), skin/genitalia (50%), and eye compartment (15%). An orphan disease and area of unmet medical need affecting approximately 18,000 people in the United States (U.S.) and 80,000 in Europe, there are as many as 1,000,000 people worldwide living with this painful and life altering disease.  Terms of the deal were not disclosed.

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“The novel muco-adherent topical formulation of PTX has the potential to fill a significant void in the current treatment armamentarium for BD, where a clear unmet medical need exists,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “General agreement amongst treating physicians is that current front-line treatment/management options, such as oral and topical steroids, are largely ineffective and have a number of potentially significant safety issues when used long-term. When transitioning to the more effective therapies, like biologics (e.g., adalimumab) and apremilast, the only approved treatment in BD, these longer-term safety concerns persist and are associated with a much higher financial burden to patients and/or payors in treating this lifelong condition. PTX has the potential to be an efficacious, safe, and more cost-effective treatment in BD. With the positive Phase 2 proof-of-concept (POC) study demonstrating accelerated oral ulcer healing and decreased pain compared to standard of care in patients with BD, we will be working to complete our remaining diligence activities under the exclusive option agreement, including discussion with the U.S. Food and Drug Administration (FDA) on the appropriate Phase 2/3 trial design to advance PTX in this orphan indication.”    

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PTX was found to be superior to colchicine in a Phase 2 POC trial.  This trial enrolled patients with BD randomized to standard of care colchicine therapy (n=21) or colchicine plus topical PTX (n=18). Patients applied the designed PTX mucoadhesive gel four times daily for up to 14 days to treat existing mouth ulcers, in addition to their standard colchicine regimen. Eighty-three percent (83%) of patients receiving PTX had index ulcer area shrinkage by Day 2, compared to 19% of patients receiving colchicine only (p<0.0001). By Day 4, 72% of patients receiving PTX had an undetectable index mouth ulcer, as compared to 29% of patients receiving colchicine only (p<0.0001). In parallel, pain scores were also found to decrease in patients taking PTX. No serious adverse events were reported, consistent with the systemic use of PTX in the published literature.

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About Pentoxifylline

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Pentoxifylline (PTX) is a known drug, administered orally, for the treatment of intermittent claudication (intermittent blockage of blood flow to muscles causing cramps). It has been FDA approved as an oral drug since 1999 and has an extensive safety database. PTX is known to have a number of biological actions. It inhibits erythrocyte phosphodiesterase, modulates neutrophil motility and functions as both an immunomodulator and an anti-inflammatory drug, including reducing TNF-alpha.

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PTX has received both Orphan Drug and Fast Track designation from the FDA. It is being developed under a 505(b)(2) accelerated regulatory pathway in the U.S.  

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About Behçet’s Disease

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Behçet’s Disease (BD) is commonly known as an inflammatory disorder of the blood vessels (vasculitis). Often first diagnosed in young adults, its effects and severity will wax and wane over time. Major signs and symptoms usually include mouth sores (approximately 95% of patients), skin rashes and lesions (approximately 50% of patients), genital sores (approximately 50% of patients) and eye inflammation (approximately 15% of patients). It is a painful disease, directly impacting the patient’s quality of life and ability to productively engage in life activities, including work.

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BD is thought to be an auto-immune disease with both genetic and environmental factors. It is most common along the “Silk Road” in the Middle East and East Asia, including Turkey, Iran, Japan and China. There are approximately 18,000 known cases of BD in the U.S. and 80,000 in Europe.  There are as many as 1,000,000 people worldwide living with BD.

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There is no cure for BD, rather treatments are prescribed to manage symptoms. Treatments may include both maintenance therapies and those specifically addressing flares (e.g., mouth ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce inflammation. Although used frequently, they have limited efficacy over the long term and have significant side effects that become more concerning with more chronic use. Other treatments for BD involve suppressing the immune system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of infection, liver and kidney problems, low blood counts and high blood pressure. Finally, anti-inflammatory drugs are also used, including anti-TNF medications. The only approved drug in BD is apremilast, which is used as a maintenance therapy to prevent formation of oral ulcers. Unfortunately, apremilast is

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associated with both high cost and side effects including diarrhea, nausea, upper respiratory tract infection and headache.

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About Soligenix, Inc.

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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) 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 (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).

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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 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 health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would

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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 it 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.

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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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Document and Entity Information
May 01, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date May 01, 2023
Securities Act File Number 001-14778
Entity Registrant Name Soligenix, Inc.
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 41-1505029
Entity Address, Address Line One 29 Emmons Drive
Entity Address, Address Line Two Suite B-10
Entity Address, City or Town Princeton
Entity Address, State or Province NJ
Entity Address, Postal Zip Code 08540
City Area Code 609
Local Phone Number 538-8200
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $.001 per share
Trading Symbol SNGX
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0000812796
Amendment Flag false
XML 9 R2.htm IDEA: XBRL DOCUMENT v3.23.1
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May 01, 2023
Cover [Abstract]  
Entity Central Index Key 0000812796
Amendment Flag false
Securities Act File Number 001-14778
Document Type 8-K
Entity Registrant Name Soligenix, Inc.
Entity Address, Address Line One 29 Emmons Drive
Entity Address, Address Line Two Suite B-10
Entity Address, City or Town Princeton
Entity Address, State or Province NJ
Entity Address, Postal Zip Code 08540
City Area Code 609
Local Phone Number 538-8200
Entity Emerging Growth Company false
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