WINDTREE THERAPEUTICS INC /DE/

ITEM 1A. RISK FACTORS

Investing in our securities involves certain risks. In addition to any risks and uncertainties described elsewhere in this Quarterly Report on Form 10-Q, investors should carefully consider the risks and uncertainties discussed in Part I, Item 1A. "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, as supplemented by risk factors included in our Quarterly Reports on Form 10-Q filed thereafter4. These risks are not the only risks that could materialize. Other than as set forth below, there have been no material changes in our risk factors from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023 or our Quarterly Reports on Form 10-Q filed thereafter4. Additional risks and uncertainties not presently known to us or that we currently consider to be immaterial may also impair our business operations and development activities. Should any of the risks and uncertainties described in our Annual Report on Form 10-K for the year ended December 31, 20234, as supplemented by our subsequent filings with the SEC, actually materialize, our business, financial condition, and/or results of operations could be materially adversely affected, the trading price of our common stock could decline, and an investor could lose all or part of his or her investment. In particular, the readers attention is drawn to the discussion in Part I, Item 2 Managements Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources.

Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations in the near term.

We do not have sufficient resources available to fund our business beyond JanuarMay 2025. To increase our cash runway, management plans to secure additional capital, potentially through a combination of public or private securities offerings, convertible debt financings, and/or strategic transactions, including potential licensing arrangements, alliances, and drug product collaborations focused on specified geographic markets; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding, or that such funding will be available on terms acceptable to us, to fund continuing operations, if at all, or identify and enter into any strategic transactions that will provide the capital that we will require.

Further, under the terms of the Purchase Agreements, we are subject to certain restrictive covenants that may make it difficult to procure additional financing. As a result of these covenants, our ability to respond to changes in business and economic conditions and engage in beneficial transactions, including to obtain additional debt or equity financing as needed in the future, on favorable terms or at all, may be limited, which could adversely affect our business, financial condition, and results of operations.

If we fail to raise sufficient capital, we potentially could be forced to limit or cease our development activities, as well as modify or cease our operations, either of which would have a material adverse effect on our business, financial condition, and results of operations. In addition, sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur, including pursuant to our existing equity line of credit, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. These conditions raise substantial doubt regarding our ability to continue as a going concern.

As a result of our failure to timely file this Quarterly Report with the SEC, we are currently ineligibOur common stock is listed on The Nasdaq Capital Market, or Nasdaq. We can provide no assurance that we will be able to file new regcomply with the continued listration stateing requirements on Form S-3, which may impairver time and that our abilitycommon stock will continue to raise capital in a timely manner or at all.

Because webe listed on Nasdaq.

In May 2020, we successfully listed our common stock on Nasdaq. However, were unable to fil can give no assurance this Quarterly Report withat we will be able to satisfy the SEC on a timely basis, we will continued listing requirements of Nasdaq in the future, including but not be eligiblelimited to register the offer and sale of our securities uthe corporate governance requirements and the minimum closing a registration statbid price requirement on Form S-3 until no earlier thar the minimum equity requirement.

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On December 14, 2025. Should 4, we wish to registereceived a deficiency letter from the Nasdaq Listing Qualifications Department, or the offer and sale of our sNasdaq Staff, notifying the Company that, for the last 30 consecurities totive business days, the public closing bid price for to the time we he Companys common stock had been below the minimum $1.00 per share eligible to use Form S-3, includirequired for continued listing for purposes of raising con The Nasdaq Capital or permittiMarket pursuant to Nasdaq Listing the resale of privately placed securities, we will be Rule 5550(a)(2), or the Minimum Bid Price Requirement. The Company timely required to fileested a registration statement on Form S-1 and have it reviewed and declared effective by the SEC. Doing so would likely take longerhearing before the Hearings Panel, or the Nasdaq Panel. On March 20, 2025, we received written confirmation from Nasdaq notifying us that we had regained compliance with the Minimum Bid Price Requirement. Nasdaq also stated than filt the Nasdaq Panel was imposing a registraDiscretion statement on Form S-3 and increase our transaction costs, making it more difficult to execute any such transaction successfully and poteary Panel Monitor until March 20, 2026, which generally will require the Nasdaq Staff to issue a Delist Determination Letter in the event that we fail to maintain compliance with any contially harminued listing our lirequidity and financial condition. Wrement.

There can be no assurance that we will also needbe able to continue to file a post-effective amendmaintain compliance with Nasdaqs continued listing requirement on Form S-1 to convert our previous Form S-3 regs, the Minimum Bid Price Requirement, or other Nasdaq listration stateing requirement with respect to resales of securities into a Form S-1, whichs. If we are not able to comply with applicable listing standards, our shares of common stock may be reviewed and will need subject to be declared effective by the SEC.

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delisting.