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Soligenix (NASDAQ: SNGX) faces Nasdaq bid-price risk and ends HyBryte program

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Soligenix, Inc. is ending development of its HyBryte™ therapy and has received a Nasdaq warning about its share price. The board decided on June 11, 2026 to terminate the HyBryte™ program after an interim analysis of the Phase 3 FLASH2 trial recommended stopping for futility. The company will wind down the study and related work and expects about $70,000 in close‑out charges. Soligenix also received notice on June 10, 2026 that its stock has traded below Nasdaq’s $1.00 minimum bid price for 30 consecutive business days, triggering a 180‑day grace period, until December 7, 2026, to regain compliance. If needed and other listing conditions are met, Soligenix may seek an additional 180‑day period, potentially via a reverse stock split. In connection with ending HyBryte™, Consulting Chief Medical Officer Dr. Richard Straube’s role will wind down, with responsibilities shifting to Medical Director Dr. Christopher Pullion. The company plans to evaluate strategic options, including mergers and acquisitions, and focus on other pipeline assets such as dusquetide (SGX945) for Behçet’s Disease.

Positive

  • None.

Negative

  • HyBryte™ development terminated: After a Phase 3 interim analysis recommended halting the FLASH2 trial for futility, the board decided on June 11, 2026 to end the HyBryte™ program, removing a late‑stage asset from Soligenix’s pipeline.
  • Nasdaq minimum bid-price noncompliance: Soligenix received a Nasdaq notice on June 10, 2026 that its stock failed to meet the $1.00 minimum bid price for 30 consecutive business days, creating a risk of eventual delisting if compliance is not restored.

Insights

Key HyBryte program halted; Nasdaq compliance risk emerges.

Soligenix is terminating its HyBryte™ development after a Phase 3 interim analysis recommended stopping for futility. This effectively removes a key late‑stage asset and leaves future value more dependent on earlier‑stage programs and potential strategic transactions.

The company also received a Nasdaq notice after its stock stayed below the $1.00 minimum bid price for 30 consecutive business days. It has 180 days, until December 7, 2026, to achieve a closing bid at or above $1.00 for at least ten consecutive business days to regain compliance.

Failure to regain compliance could lead to delisting, although an additional 180‑day period is possible if other listing standards are met and a cure plan, including a potential reverse stock split, is provided. Meanwhile, Soligenix highlights dusquetide (SGX945), which carries multiple regulatory designations, as a remaining pipeline focus.

Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing Securities
The company received a delisting notice or transferred its listing to a different exchange.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers Governance
Key personnel changes including departures, elections, or appointments of directors and executive officers.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Nasdaq minimum bid price $1.00 per share Required under Nasdaq Listing Rule 5550(a)(2)
Consecutive days below minimum 30 business days Period triggering Nasdaq noncompliance notice
Initial compliance period 180 calendar days Time allowed to regain bid-price compliance, until December 7, 2026
HyBryte wind-down charges $70,000 Estimated clinical trial close-out and related costs
Consulting CMO hourly fee $1,000 per hour Rate under Consulting Agreement for up to 10 hours per month
Consulting hours cap 10 hours per month Maximum billable hours under prior Consulting Agreement
Nasdaq Listing Rule 5550(a)(2) regulatory
"not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2)"
Data Monitoring Committee medical
"the Data Monitoring Committee (the “DMC”) completed an interim efficacy analysis"
A data monitoring committee is a group of experts responsible for reviewing and overseeing important information during a project or study to ensure everything is proceeding safely and correctly. For investors, it provides an extra layer of oversight, helping to identify potential issues early and ensuring that decisions are based on accurate, unbiased data. This helps maintain trust and safety throughout the process.
orphan drug designation medical
"dusquetide (SGX945) for the treatment of Behçet’s Disease, which has received orphan drug designation from the U.S. Food and Drug Administration"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
Promising Innovative Medicine designation medical
"Promising Innovative Medicine designation from the UK Medicines and Healthcare products Regulatory Agency"
reverse stock split financial
"intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary"
A reverse stock split is when a company reduces the number of its shares outstanding, making each share more valuable. For example, if you own 100 shares worth $1 each, a 1-for-10 reverse split would turn your 100 shares into 10 shares worth $10 each. Companies often do this to boost their stock price and appear more stable to investors.
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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): June 10, 2026

 

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)

(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 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

On June 10, 2026, Soligenix, Inc. (the “Company”) received a written notice (the “Bid Price Notice”) from the Listing Qualifications department (the “Nasdaq Staff”) of The Nasdaq Stock Market (“Nasdaq”) indicating that the Company is not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. The notification of noncompliance has no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq Capital Market under the symbol “SNGX,” and the Company is currently monitoring the closing bid price of its common stock and evaluating its alternatives, if appropriate, to resolve the deficiency and regain compliance with this rule.

The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price for the last 30 consecutive business days, the Company no longer meets this requirement. The Bid Price Notice indicated that the Company will be provided 180 calendar days, or until December 7, 2026, in which to regain compliance. If at any time during this period the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq Staff will provide the Company with a written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, the Nasdaq Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a Nasdaq Listing Qualifications Panel.

Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, but meets the continued listing requirement for market value of publicly held shares and all of the other applicable standards for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price, and provides written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary, then the Company may be granted an additional 180 calendar days to regain compliance with Rule 5550(a)(2).

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

As previously disclosed, Richard C. Straube, MD, retired from his employment as Chief Medical Officer and Senior Vice President of Soligenix, Inc. (the “Company”) effective August 12, 2025 and entered into a one-year consulting agreement (the “Consulting Agreement”), pursuant to which Dr. Straube served as the Company’s Consulting Chief Medical Officer effective August 16, 2025. Under the Consulting Agreement, Dr. Straube served as an independent contractor and received an hourly consulting fee of $1,000 per hour for up to ten hours per month of consulting work.

On June 11, 2026, in connection with the Company’s decision to terminate the HyBryte™ development program as described under Item 8.01 below, Dr. Straube ceased serving as the Company’s Consulting Chief Medical Officer.  The Company and Dr. Straube have agreed that Dr. Straube will continue to be available to consult with the Company on an as-needed, hourly basis. In the interim, Dr. Straube’s responsibilities will be transitioned to Dr. Christopher Pullion, the Company’s Medical Director.

Item 8.01 Other Events.

 

Termination of the HyBryte™ Development Program

As previously reported in the Company’s Current Report on Form 8-K filed on April 28, 2026, the Data Monitoring Committee (the “DMC”) completed an interim efficacy analysis of the Company’s confirmatory Phase 3 FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) clinical trial evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma and recommended that the study be halted for futility.  Following a thorough

2

review of the DMC’s recommendation and evaluation of the program’s path forward, on June 11, 2026, the Company’s Board of Directors determined that it is in the best interest of the Company and its stockholders to terminate the HyBryte™ development program.

The Company will undertake an orderly wind-down of the FLASH2 trial and related HyBryte™ development activities. The Company estimates that it will incur approximately $70,000 in charges in connection with the wind-down of the HyBryte™ program, consisting primarily of clinical trial close-out costs and related expenses.

The Company intends to continue to evaluate all strategic options moving forward, including but not limited to merger and acquisition opportunities, as well as the potential of advancing its other pipeline programs, including dusquetide (SGX945) for the treatment of Behçet’s Disease, which has received orphan drug designation from the U.S. Food and Drug Administration, orphan drug designation from the European Commission, and Promising Innovative Medicine designation from the UK Medicines and Healthcare products Regulatory Agency.

Safe Harbor for Forward-Looking Statements

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 Securities Exchange Act of 1934.  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 Company’s ability to regain compliance with the Nasdaq Listing Rule 5550(a)(2) minimum bid price requirement within the applicable compliance period, the potential delisting of the Company’s common stock from The Nasdaq Capital Market and the potential adverse effects of such delisting on the trading price and liquidity of the Company’s common stock, the Company’s ability to satisfy the requirements for a second compliance period, the uncertainty of identifying, evaluating and completing strategic transactions, including merger and acquisition opportunities, on favorable terms or at all, the ability of the Company to successfully advance its alternative pipeline programs, including dusquetide (SGX945) for the treatment of Behçet’s Disease, the sufficiency of the Company’s capital resources to fund operations and pursue strategic alternatives, and the other 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, 2025 on Form 10-K, which was filed with the SEC, and in other periodic reports on Form 10-Q and Form 8-K. 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.

Item 9.01. Financial Statements and Exhibits.

(d)     Exhibits.

Exhibit No.

  ​ ​ ​

Description

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. 

June 12, 2026

By:

/s/ Christopher J. Schaber 

 

 

Christopher J. Schaber, Ph.D.

President and Chief Executive Officer

(Principal Executive Officer)

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FAQ

What did Soligenix (SNGX) announce about its HyBryte program?

Soligenix decided to terminate its HyBryte™ development program after a Data Monitoring Committee recommended halting the Phase 3 FLASH2 trial for futility. The company will wind down the study and related activities, expecting about $70,000 in clinical close‑out and related charges.

Why did Soligenix (SNGX) receive a Nasdaq bid-price notice?

Soligenix received a Nasdaq notice because its common stock’s closing bid price stayed below $1.00 for 30 consecutive business days. Nasdaq Listing Rule 5550(a)(2) requires a minimum bid of $1.00 per share for continued listing on the Nasdaq Capital Market.

How long does Soligenix (SNGX) have to regain Nasdaq compliance?

Soligenix has 180 calendar days, until December 7, 2026, to regain compliance. If the stock closes at or above $1.00 for at least ten consecutive business days during this period, Nasdaq staff will confirm compliance and close the matter.

Can Soligenix (SNGX) get more time beyond the initial 180 days?

Yes. If Soligenix meets other initial listing standards, except for bid price, and notifies Nasdaq it intends to cure the deficiency, potentially via a reverse stock split, it may receive an additional 180‑day period to regain compliance with Rule 5550(a)(2).

What financial impact does ending HyBryte have on Soligenix (SNGX)?

The company estimates about $70,000 in charges from winding down the HyBryte™ program. These costs mainly relate to clinical trial close‑out and associated development activities, rather than ongoing operating expenses or large restructuring charges.

What is happening with Soligenix’s (SNGX) Chief Medical Officer role?

Consulting Chief Medical Officer Dr. Richard Straube stopped serving in that role on June 11, 2026, tied to the end of HyBryte™ development. His responsibilities will transition to Medical Director Dr. Christopher Pullion, although Dr. Straube may consult on an as‑needed basis.

Which pipeline program is now a focus for Soligenix (SNGX)?

Soligenix highlights dusquetide (SGX945) for Behçet’s Disease as a continuing pipeline opportunity. Dusquetide has orphan drug designation from the U.S. FDA and European Commission, and a Promising Innovative Medicine designation from the UK Medicines and Healthcare products Regulatory Agency.

Filing Exhibits & Attachments

4 documents