SOLIGENIX, INC.

Previous wording

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.

Current wording

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.

Previous wording

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

Current wording

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).

Previous wording

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 June 30, 2026, our stockholders' equity was approximately $6.6 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 and $6.6 million at June 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.

Current wording

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.

Previous wording

Nasdaq has adopted amendments to its continued listing standards that 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. Under the adopted rules, 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, this new requirement 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.

Current wording

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.

Previous wording

Shareholders may suffer substantial dilution related to issued pre-funded warrants, common stock warrants, options and convertible notes.

Current wording

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