CURIS INC

We are subject to a number of risks that could materially and adversely affect our business, financial condition, and results of operations and future prospects, including those identified in Item 1A, “Risk Factors” of Part I of our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 24, 2026, as supplemented by the updated risk factors set forth below. Other than the risk factors described below, as of September 30, 2026, there have been no material changes from the risk factors previously disclosed in response to Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2025.

We will require substantial funds to maintain our research and development program and support operations in the near term. We have incurred losses and negative cash flows from operations since our inception. As of September 30, 2026, we had $5.0 million in cash and cash equivalents. In October 2026, we completed the October 2026 Private Placement for net proceeds of approximately $7.5 million, after deducting placement agent fees and offering expenses. Based upon our current operating plan, we believe that our $5.0 million of existing cash and cash equivalents as of September 30, 2026, together with the net proceeds of approximately $7.5 million from the October 2026 Private Placement, should enable us to fund our existing operations into the first quarter of 2027. We have based this assessment on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Based upon our current cash and cash equivalents, recurring losses and cash outflows from operations since inception, an expectation of continuing losses and cash outflows from operations for the foreseeable future and the need to raise additional capital to finance our future operations, we have concluded that we do not have sufficient cash on hand to support current operations beyond the next 12 months from the date of filing this Quarterly Report on Form 10-Q.

We will require substantial additional funding to fund the development of emavusertib through regulatory approval and commercialization, and to support our continued operations. We will need to seek additional funding through several potential avenues, including private or public equity financings, collaborations, or other strategic transactions. We have faced and expect to continue to face substantial difficulties in raising capital. If sufficient funds are not available, we will have to delay, reduce the scope of, or eliminate our research and development program for emavusertib, including related clinical trials and operating expenses, potentially delaying the time to market for or preventing the marketing of emavusertib, which would adversely affect our business prospects and our ability to continue our operations, and would have a negative impact on our financial condition and ability to pursue our business strategies. In addition, we may seek to engage in one or more strategic alternatives, such as a strategic partnership with one or more parties, the licensing, sale or divestiture of some of our assets or proprietary technologies or the sale of our company, but there can be no assurance that we would be able to enter into such a transaction or transactions on a timely basis or on terms favorable to us, or at all. If we are unable to obtain sufficient capital, we would be unable to fund our operations and may be required to evaluate alternatives, which could include dissolving and liquidating our assets or seeking protection under the bankruptcy laws, and a determination to file for bankruptcy could occur at a time that is earlier than when we would otherwise exhaust our cash resources. If we decide to dissolve and liquidate our assets or to seek protection under the bankruptcy laws, it is unclear to what extent we would be able to pay our obligations, and, accordingly, it is further unclear whether and to what extent any resources would be available for distributions to stockholders.

If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried or commence proceedings under Chapter 11 of the U.S. Bankruptcy Code, and it is likely that investors will lose all or a part of their investment. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all. If we were required to commence proceedings under Chapter 11 of the U.S. Bankruptcy Code, our operations and ability to develop and execute our business plan, and our ability to continue as a going concern, would be subject to the risks and uncertainties associated with bankruptcy. As such, filing for Chapter 11 would likely have a material adverse effect on our business, financial condition, results of operations and liquidity.

We are not in compliance with the requirements for continued listing on the Nasdaq Capital Market. If we fail to regain and maintain compliance with Nasdaq’s requirements, our common stock could be delisted from trading, which would decrease the liquidity of our common stock and our ability to raise additional capital.

Our common stock is currently listed on the Nasdaq Capital Market. We are required to meet specified requirements to maintain our listing on the Nasdaq Capital Market.

On November 2, 2026, we received a letter (the “Delist Determination Letter”) from the Listing Qualifications Staff (the “Staff”) of Nasdaq notifying us that, for the last 30 consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued inclusion on Nasdaq Capital Market as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). On July 6, 2026 the Company effected a 1-for-20 reverse stock split. Because we effected a 1-for-20 reverse stock split on July 6, 2026, we are not eligible for any compliance period under Nasdaq Listing Rule 5810(c)(3)(A)(iv). As a result, our common stock was scheduled to be suspended from the Nasdaq Capital Market at the opening of business on November 11, 2026, unless we requested a hearing before a Panel by November 9, 2026. On November 9, 2026, we timely requested a hearing before the Panel, which stayed the suspension of our common stock and further delisting actions.] In addition, in an effort to regain compliance with the Bid Price Rule, we have scheduled a special meeting of stockholders on November 18, 2026 to vote on a reverse stock split at a ratio ranging from 1-for-5 to 1-for-12 (the “November Reverse Stock Split”). However, there can be no assurance that our stockholders will approve the November Reverse Stock Split, that the November Reverse Stock Split will result in a sustained bid price above $1.00 per share, that our appeal will be successful or that we will remain listed on Nasdaq.

Because we are subject to the Discretionary Panel Monitor, notwithstanding Rule 5810(c)(2), we are not permitted to provide Staff with a plan of compliance with respect to this or any other deficiency that arises during the monitor period, and Staff will not be permitted to grant additional time for us to regain compliance with respect to any deficiency. The Hearings Panel will consider our compliance history when rendering its decision. However, there can be no assurance that such appeal will be successful or that the Company will remain listed on Nasdaq.

If we fail to satisfy the Nasdaq Capital Market’s continued listing requirements and we are delisted from Nasdaq, we may transfer to and commence trading on the OTC Markets or another quotation medium. As a result, an investor would likely find it more difficult to trade or obtain accurate price quotations for our shares. Delisting would likely also reduce the visibility, liquidity, and value of our common stock, could have a material adverse effect on our access to capital markets and our ability to raise capital on terms acceptable to us, or at all, to provide stock-based incentives to attract and retain personnel, reduce institutional investor interest in our company, and may increase the volatility of our common stock. Delisting could also be considered a material adverse event or an event of default in certain of our third-party contracts or cause a loss of confidence of potential industry partners, lenders, and employees, which could further harm our business and our future prospects. In addition, our common stock could be deemed to be a “penny stock,” which could result in reduced levels of trading in our common stock, and we would also become subject to additional state securities regulations in connection with any sales of our securities. Some or all of these material adverse consequences may contribute to a further decline in our stock price.

Our 2026 Reverse Stock Splits may decrease the liquidity of our common stock.

On July 6, 2026, we effected a 1-for-20 reverse stock split of our common stock (the “July Reverse Stock Split”). Thereafter, to regain compliance with the Bid Price Rule, we called a shareholder meeting to vote to approve the November Reverse Stock Split (and, together with the July Reverse Stock Split, the “2026 Reverse Stock Splits”). If the November Reverse Stock Split is approved by stockholders and effected by the Company, the liquidity of our common stock may be adversely affected given the reduced number of shares outstanding following such 2026 Reverse Stock Splits, which may lead to reduced trading and a smaller number of market makers for our common stock, particularly if the per-share trading price does not increase as a result of the November Reverse Stock Split. In addition, the July Reverse Stock Split may have increased, and the November Reverse Stock Split, if approved and effected, may increase the number of stockholders who own “odd lots” of less than 100 shares of our common stock. Odd lot shares may be more difficult to sell, and brokerage commissions and other costs of transactions in odd lots may be higher than the costs of transactions in “round lots” of even multiples of 100 shares.

Following the July Reverse Stock Split and the November Reverse Stock Split, if approved and effected, the resulting per-share trading price of our common stock may fail to attract or retain investors and may not satisfy the investing guidelines of institutional investors and, consequently, the trading liquidity of our common stock may be adversely impacted.