SOLIGENIX, INC.

Our business faces significant risks. These risks are disclosed in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our other periodic reports on Form 10-Q and Form 8-K. If any of the events or circumstances described in the referenced risks actually occur, our business, financial condition or results of operations could be materially adversely affected and such events or circumstances could cause our actual results to differ materially from the results contemplated by the “forward-looking” statements contained in this report. Further, additional risks not presently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business, financial condition and results of operations. We do not undertake to update any of the “forward-looking” statements or to announce the results of any revisions to these “forward-looking” statements, except as required by law.

Other than as set forth below, there have been no material changes to the risk factors disclosed in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. The following risks should be read in conjunction with the other information set forth in this Quarterly Report as well as in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our periodic reports on Form 10-Q and Form 8-K.

Risks Related to Our Securities

If we fail to meet Nasdaq's listing requirements, including the minimum bid price requirement, and the minimum stockholders’ equity requirement, we could be removed from The Nasdaq Capital Market, which would limit the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market and negatively impact our ability to raise capital.

On June 10, 2026, 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 10 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).

Additionally, The Nasdaq Capital Market requires listed companies to satisfy at least one of three alternative financial condition standards for continued listing: (i) stockholders' equity of at least $2.5 million, (ii) market value of listed securities of at least $35 million, or (iii) net income from continuing operations of at least $500,000 in the most recently completed fiscal year or in two of the last three fiscal years. As of September 30, 2026, our stockholders' equity was approximately $6.3 million, and we do not currently satisfy either of the two alternative financial condition standards. Given our history of net losses and the fluctuations in our stockholders' equity—from $5.3 million at December 31, 2025 to $3.1 million at March 31, 2026, $6.6 million at June 30, 2026, and $6.3 million at September 30, 2026—we may be unable to maintain stockholders' equity at or above the $2.5 million minimum absent a significant capital raise or other equity-positive transaction. If our stockholders' equity falls below $2.5 million and we are unable to satisfy an alternative financial condition standard, Nasdaq may notify us that we are not in compliance with its continued listing requirements. There can be no assurance that we will be able to regain compliance if we receive such a notification. If we do not meet these requirements, the market liquidity for our securities could be severely adversely affected by limiting the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market.

On July 22, 2026, the U.S. Securities and Exchange Commission (the “SEC”) approved amendments to Nasdaq’s continued listing standards that would require companies listed on The Nasdaq Global Select Market, The Nasdaq Global Market, and The Nasdaq Capital Market to maintain a minimum market value of listed securities (“MVLS”) of at least $5 million (the “MVLS Rule”). Under the MVLS Rule, if a company’s MVLS remains below $5 million for a period of 30 consecutive business days, Nasdaq will issue a staff delisting determination and immediately suspend trading of the company’s securities, without providing a cure or compliance period. In addition, a timely request for a hearing before a Nasdaq Listing Qualifications Hearings Panel will not stay the suspension of trading, and the company’s securities would generally trade in the over-the-counter market pending the outcome of any appeal. The Hearings Panel’s authority to grant relief on appeal is narrower than in most other continued listing matters: the Hearings Panel may reverse a delisting determination only if it finds the determination was made in error, or may grant an exception of up to 180 days for the company to demonstrate that it satisfies Nasdaq’s initial listing requirements, which are generally more stringent than the continued listing standards from which the company fell out of compliance. The Hearings Panel does not otherwise have discretion to excuse a temporary or good-faith shortfall or to grant additional time to regain compliance with the ordinary continued listing standards, as it can for most other continued listing deficiencies. Because the Company’s market value is subject to significant fluctuation and could decline below $5 million for a sustained period, particularly during periods of adverse clinical, regulatory, or market developments, the MVLS Rule, if it becomes operative, could materially increase the risk of immediate suspension and delisting during periods of sustained market capitalization decline, which would likely have a material adverse effect on the Company’s liquidity and the market price of the Company’s common stock and its ability to raise additional capital.

The SEC subsequently received notices of intention to petition for review of the MVLS Rule, which automatically stayed the MVLS Rule effective July 29, 2026. On September 11, 2026, the SEC granted the petitions for review and continued the stay pending further order. On September 25, 2026, Nasdaq filed a proposed rule change, notice of which the SEC published on October 5, 2026, providing that the MVLS Rule will become operative only upon termination of the stay and that the 30-consecutive-business-day measuring period will begin on the business day immediately following termination of the stay. Nasdaq’s proposed rule change was designated as immediately effective, but the SEC may summarily suspend it within 60 days of its filing. As of the date of this report, the stay remains in effect and the MVLS Rule is not operative. There can be no assurance as to whether or when the stay will be lifted, whether the MVLS Rule will become operative in its current or a modified form, or whether the SEC will suspend Nasdaq’s proposed rule change.

If our common stock is delisted from Nasdaq, it will have material negative impact on the actual and potential liquidity of our securities, as well as material negative impact on our ability to raise future capital. If, for any reason, Nasdaq should delist our common stock from trading on its exchange and we are unable to obtain listing on another national securities exchange or take action to restore our compliance with the Nasdaq continued listing requirements, a reduction in some or all of the following may occur, each of which could have a material adverse effect on our shareholders:

Shareholders may suffer substantial dilution related to outstanding common stock warrants and, options.

As of October 30, 2026, we had a number of agreements or obligations that may result in dilution to investors. These include:

We have granted, and expect to grant in the future, options to purchase shares of our common stock to our directors, employees and consultants under our 2025 Equity Incentive Plan. To the extent that common stock warrants or options are exercised, our stockholders will experience dilution and our stock price may decrease.