CRIS

MKT CAP $815KP/E —DIV YIELD —FCF YIELD —REV TTM $4.3M −62.2%NET INCOME −$21.2MNET CASH $4.2M52W 0.38 – 31.20SEC XBRL · TTM TO Invalid Date

How CRIS rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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As of December 31, 2025, we had $5.1 million in cash and cash equivalents.
In January 2026, we completed the January 2026 PIPE Financing for net proceeds of approximately $18.6 million.
We will require substantial additional funding to fund the development of emavusertib through regulatory approval and commercialization, and to support our continued operations.
We have faced and expect to continue to face substantial difficulties in raising capital.
Our net loss was $7.6 million for the year ended December 31, 2025, inclusive of a one-time non-cash gain on release of liability related to sale of future royalties associated with sale of assets of $27.2 million.
As of December 31, 2025, we had an accumulated deficit of $1.2 billion.
We have not completed the development of any drug candidate on our own and we may never have a drug candidate Table o f Contents approved for commercialization.
We do not expect to generate significant revenues unless and until we are, or any collaborator is, able to obtain marketing approval for, and successfully commercialize emavusertib.
We do not currently have any committed external source of funds.
Our ability to raise additional funds in the future will depend on our ability to enroll patients in the TakeAim CLL study, reaching internal operational milestones, financial, economic and market conditions, many of which are outside of our control, and we may be unable to raise financing when needed, or on terms favorable to us, or at all.
If we are unable to obtain sufficient funding, we may be forced to delay, reduce in scope or eliminate our research and Table o f Contents development program for emavusertib, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, emavusertib.
We sold no shares of common stock under the 2024 Sales Agreement during the twelve months ended December 31, 2025.
As long as our public float is under $75.0 million, we are restricted from selling shares of our common stock under our shelf registration statement on Form S-3, including those sold under the 2024 Sales Agreement to an amount, in aggregate, that is no more than one-third of our public float during the 12 month period immediately prior to, and including, any such sale.
Table o f Contents Our ability to generate drug revenues, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of emavusertib.
Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect of emavusertib that is greater than the actual positive effect, if any; • adverse events or undesirable side effects caused by, or other unexpected properties of, emavusertib could cause us, any collaborators, an institutional review board or regulatory authorities to interrupt, delay or halt clinical trials of emavusertib and could result in a more restrictive label or the delay or denial of marketing approval by the FDA or comparable foreign regulatory authorities; • we cannot be certain that we will not observe safety events in our clinical trials, which may lead to future clinical holds, or necessitate additional or amended trials. • if emavusertib is associated with adverse events or undesirable side effects or has properties that are unexpected, we, or any collaborators, may need to abandon development or limit its development to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. • regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we, or any collaborators, may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites; • clinical trials of emavusertib may produce unfavorable or inconclusive results, including with respect to its safety, tolerability, efficacy, or pharmacodynamic and pharmacokinetic profile; • we, or any collaborators, may decide, or regulators may require us, to conduct additional clinical trials or abandon our drug development program; • the number of patients required for clinical trials of emavusertib may be larger than we anticipate, patient enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; • our estimates of the patient populations available for study may be higher than actual patient numbers and result in our inability to sufficiently enroll our trials; • the cost of ongoing and any future clinical trials of emavusertib may be greater than we anticipate; • our third party contractors, including those manufacturing emavusertib or components or ingredients thereof or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner or at all; Table o f Contents • patients that enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the patients from the clinical trial, increase the needed enrollment size for the clinical trial or extend the clinical trial’s duration; • the FDA or comparable foreign regulatory authorities may disagree with our, or any collaborators', clinical trial designs or our or their interpretation of data from preclinical studies and clinical trials; • the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or facilities of third party manufacturers with which we, or any collaborators, enter into agreements for clinical and commercial supplies; • the supply or quality of raw materials or manufactured emavusertib or other materials necessary to conduct clinical trials of emavusertib may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; • subsequent formulations of emavusertib may require additional testing and may not be comparable to the current formulations; • the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient to obtain marketing approval; • constraints on our, or any collaborators’, ability to conduct or complete clinical trials for emavusertib, including slowdowns in patient enrollment, restrictions on patient monitoring at hospital clinical trial sites, closures of third party facilities, and other disruptions to clinical trial activities; and • any delay in enrolling patients or our inability to continue or complete our clinical trials of emavusertib will delay or may cause us to terminate our clinical development plans for emavusertib, may require us to incur additional clinical development costs, may slow down our drug candidate development and approval process, and could impair our ability to ultimately obtain FDA approval for emavusertib and commence product sales and generate revenue.
Patient enrollment is a significant factor in the timing of clinical trials, and is affected by many factors, including: • our ability to successfully enroll patients with primary central nervous system lymphoma in the TakeAim Lymphoma Phase 1/2 study and/or patients with chronic lymphocytic leukemia in the TakeAim CLL Phase 2 study; • the size and nature of the patient population; • the severity of the disease under investigation; Table o f Contents • the availability of approved therapeutics for the relevant disease; • the proximity of patients to clinical sites; • the eligibility criteria and design for the trial; • efforts to facilitate timely enrollment; • competing clinical trials; and • clinicians’ and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.
For example, the FDA does not accept or approve our NDAs for emavusertib, it may require that we conduct additional clinical Table o f Contents trials, preclinical studies or manufacturing validation studies and submit that data before it will reconsider our application.
The degree of market acceptance of emavusertib, if approved for commercial sale, will depend on a number of factors, including: • the efficacy and safety of the drug; • the potential advantages of the drug compared to competitive therapies; • the prevalence and severity of any side effects; • whether the drug is designated under physician treatment guidelines as a first-, second- or third-line therapy; • our ability, or the ability of any future collaborators, to offer the drug for sale at competitive prices; Table o f Contents • the drug’s convenience and ease of administration compared to alternative treatments; • the willingness of the target patient population to try, and of physicians to prescribe, the drug and patient adherence to the drug’s dosing regimen once prescribed; • limitations or warnings, including distribution or use restrictions, contained in the drug’s approved labeling; • the strength of sales, marketing and distribution support; • changes in the standard of care for the targeted indications for the drug; and • availability and amount of coverage and reimbursement from government payors, managed care plans and other third party payors.
Emavusertib faces competition from existing and new technologies and drugs being developed by biotechnology, medical device, and pharmaceutical companies, as well as universities and other research institutions.
We believe our primary competitors for emavusertib are those companies pursuing oncology indications in IRAK4, CLL, PCNSL, AML with a FLT3 mutation, and frontline AML combinations with azacitidine and venetoclax.
Companies pursuing IRAK 4 inhibitors include a pre-clinical stage company, Kurome Therapeutics (KME-0584 – IRAK1/4 / FLT3) and four clinical and/or commercial stage companies, Rigel Pharmaceuticals, Inc.
(R289), AstraZeneca Table o f Contents (AZD2962), Hangzhou Polymed Biopharmaceuticals (HPB-092 – IRAK4 / FLT3) and Eilean Therapeutics (lomonitinib – IRAK4 / FLT3).
AstraZeneca PLC has an approved BTK inhibitor, acalabrutinib, which is approved for use in combination with venetoclax as a treatment for CLL.
Companies pursuing frontline CLL in combination with a BTK inhibitor include BeOne Medicines (formerly BeiGene Ltd.) (zanubrutinib in combination with venetoclax) and AbbVie Inc. together with Johnson & Johnson (ibrutinib in combination with venetoclax).
Other companies with BTK inhibitor–based combinations or next‑generation BTK‑pathway agents that may be used in combination in frontline CLL include AbbVie Inc. and Johnson & Johnson (ibrutinib‑based regimens), Eli Lilly and Company (pirtobrutinib), and Nurix Therapeutics, Inc.
Companies pursuing PCNSL in combination with a BTK inhibitor include Bayer AG (copanlisib in combination with ibrutinib).
Other companies pursuing PCNSL include Gilead Sciences, Inc.
(tirabrutinib), and BeOne Medicines (zanubrutinib in combination with rituximab and methotrexate).
(gilteritinib) has an approved FLT3 inhibitor as do Daiichi Sankyo (quizartinib), Jiangsu Hengrui (famitinib malate (approved in China), and Novartis (midostaurin).
(HEC73543), Ellipses Pharma (EP0042), CSPC Pharmaceuticals Group Limited (SKLB1028), Kurome Therapeutics (KME-0584 – IRAK1/4 / FLT3), Hangzhou Polymed Biopharmaceuticals (HPB-092 – IRAK4 / FLT3) and Eilean Therapeutics (lomonitinib – IRAK4 / FLT3).
If we are not able to compete effectively, then we may not be able, either alone or with others, to advance the development and commercialization of emavusertib, which would adversely affect our ability to grow our business and become profitable.
As a result, the coverage determination process is often a time consuming and costly process Table o f Contents that may require us to provide scientific and clinical support for the use of our drugs to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.
RISKS RELATING TO OUR DEPENDENCE ON THIRD PARTIES Table o f Contents We may not be successful in establishing additional strategic collaborations, which could adversely affect our ability to develop and commercialize emavusertib, which we have strategically determined to pursue with a collaborator.
We rely heavily on third parties to conduct clinical trials of emavusertib, and if such third parties perform inadequately, including failing to meet deadlines for the completion of such trials, research or testing, then we may not be able to successfully develop and commercialize emavusertib and grow our business.
Table o f Contents We depend on third parties to produce emavusertib, and if these third parties do not successfully formulate or manufacture the drug candidate, our business could be harmed.
Table o f Contents Because we rely on a limited number of suppliers for the raw materials used in emavusertib, any delay, shortage or interruption in the supply of such raw materials or contamination in our manufacturing process could lead to delays in the manufacture and supply of emavusertib.
Collaborations involving our drug candidates, including our collaboration with Aurigene pose the following risks, among others, to us: • Our collaborators have significant discretion in determining the efforts and resources that they will apply to their collaboration with us.
If our collaborators fail to allocate sufficient time, attention and resources to our collaboration, the successful development and commercialization of drug candidates under such collaboration is likely to be adversely affected. • Our collaborators may develop and commercialize, either alone or with others, drugs that are similar to or competitive with the drug candidates that are the subject of our respective collaborations.
For example, Aurigene has other active cancer-focused discovery programs and has also entered into license agreements with other companies that focus on cancer therapies. • Our collaborators may change the focus of their development and commercialization efforts or pursue higher-priority programs and there can be no assurance that third parties engaged to develop or commercialize our drug candidates or products will succeed in developing or commercializing our products or devote sufficient resources to the development or commercialization of our drug candidates or products.
In addition, potential competitors may have substantially greater financial and other resources and may be able to expend more funds and effort with respect to competing products than third parties engaged by us. • Our collaborators may enter into one or more transactions with third parties, including a merger, consolidation, reorganization, sale of substantial assets, sale of substantial stock or change of control.

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Gone since FY2024

As of December 31, 2024, we had $20.0 million in cash and cash equivalents.
In March 2025, we completed a registered direct offering and concurrent private placement for net proceeds of approximately $9.0 million.
We expect these available cash resources, together with the proceeds from the March 2025 offering, to fund our existing operations into the fourth quarter of 2025.
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.
We will require substantial additional funding in the immediate term to fund the development of emavusertib through regulatory approval and commercialization, and to support our continued operations.
We have faced and expect to continue to face substantial difficulty in raising capital.
Our net loss was $43.4 million for the year ended December 31, 2024.
As of December 31, 2024, we had an accumulated deficit of $1.2 billion.
We have not completed the development of any drug candidate on our own.
Other than Erivedge ® , which is being commercialized and further developed by Genentech and Roche under our collaboration agreement with Genentech, we may never have a drug candidate approved for commercialization.
Our only current source of revenues comprises licensing and royalty revenues that we earn under our collaboration with Genentech related to the development and commercialization of Erivedge.
A significant portion of our royalty and royalty related revenues under our collaboration with Genentech will be paid to TPC Investments I LP and TPC Investments II LP, or the Purchasers, pursuant to the royalty interest purchase agreement we and Curis Royalty entered into with the Purchasers and Lind SA LLC, or Agent, on March 22, 2019, or the Oberland Purchase Agreement.
We do not expect to generate significant revenues other than those related to Erivedge unless and until we are, or any collaborator is, able to obtain marketing approval for, and successfully commercialize emauvsertib.
Moreover, our agreements with collaborators impose significant potential financial obligations on us.
Based upon our current operating plan, we believe that our existing cash and cash equivalents of $20.0 million as of December 31, 2024, together with the proceeds from the March 2025 offering, should enable us to fund our existing operations into the fourth quarter of 2025.
We have based this assessment on assumptions that may prove to be wrong, and it is possible that we will not achieve the progress that we expect with these funds because the actual costs and timing of clinical development and regulatory and commercial activities are difficult to predict and are subject to substantial risks and delays, and that we will use our capital resources sooner than we currently expect.
This estimate does not reflect any additional expenditures that may result from any further strategic transactions to expand and diversify our product pipeline, including acquisitions of assets, businesses, rights to products, drug candidates or technologies or strategic alliances or collaborations that we may pursue.
Our ability to raise additional funds in the future will depend on financial, economic and market conditions, many of which are outside of our control, and we may be unable to raise financing when needed, or on terms favorable to us, or at all.
If we are unable to obtain sufficient funding, we may be forced to delay, reduce in scope 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.
We sold 188,316 shares of common stock under the 2024 Sales Agreement representing gross proceeds of $1.2 million during the twelve months ended December 31, 2024.
In connection with the Oberland Purchase Agreement, we transferred and encumbered certain royalty and royalty related payments on commercial sales of Erivedge; Curis Royalty granted a first priority lien and security interest in all of its assets, including its rights to the Erivedge royalty payments; and we granted the Purchasers a first priority lien and security interest in our equity interest in Curis Royalty.
As a result, in the event of a default by us or Curis Royalty, Curis Royalty could lose all retained rights to certain future royalty and royalty related payments, Curis Royalty could be required to repurchase the Purchased Receivables at a price that is a multiple of the payments we have received, and our ability to enter into future arrangements may be inhibited, all of which could have a material adverse effect on our business, financial condition and stock price, including our ability to continue as a going concern.
Pursuant to the Oberland Purchase Agreement, the Purchasers acquired the rights to a portion of certain royalty and royalty related payments excluding a portion of non-U.S. royalties retained by Curis Royalty, referred to as the Purchased Receivables, owed by Genentech under our collaboration agreement with Genentech.
In connection with entering into the Oberland Purchase Agreement, Curis Royalty and the Agent entered into a security agreement and Curis and the Purchasers entered into a pledge agreement.
Following an event of default under the security agreement entered into between Curis Royalty and the Agent, the Agent has the right to stop all allocations of payments that would have otherwise been allocated to Curis Royalty pursuant to the Oberland Purchase Agreement and instead retain all such payments.
In addition, the Oberland Purchase Agreement provides that after the occurrence of an event of default by Curis Royalty under the security agreement, as described below, the Purchasers shall have the option, for a period of 180 days, to require Curis Royalty to repurchase the Purchased Receivables at a price, referred to as the Put/Call Price, equal to 250% of the sum of the upfront purchase price and any portion of the milestone payments paid in a lump sum by the Purchasers, if any, minus certain payments previously received by the Purchasers with respect to the Purchased Receivables.
Pursuant to the security agreement, Curis Royalty granted to the Agent a first priority lien and security interest in all of its assets and all real, intangible and personal property, including all of its right, title and interest in and to the Erivedge royalty payments.
The security interest secures the obligations of Curis Royalty arising under the Oberland Purchase Agreement, the security agreement or otherwise with respect to the due and prompt payment of (i) an amount equal to the Put/Call Price and (ii) all fees, costs, expenses, indemnities and other payments of Curis Royalty under or in respect of the Oberland Purchase Agreement and the security agreement.
The obligations of Curis Royalty under the Oberland Purchase Agreement may be accelerated upon the occurrence of an event of default under the security agreement (subject to certain cure periods), which events of default include: • any royalty and royalty related payments to be remitted into a certain Curis Royalty designated account controlled by the Agent pursuant to a control agreement, referred to as the royalty account, into which all royalty and royalty related payments must be paid by Curis or Curis Royalty are not so remitted in accordance with the Oberland Purchase Agreement; • any representation or warranty made by Curis or Curis Royalty in the Oberland Purchase Agreement or any other transaction document proves to be incorrect or misleading in any material respect when made; • a default by Curis or Curis Royalty in the performance of affirmative and negative covenants set forth in the Oberland Purchase Agreement or any other transaction document; • a default by Curis in the performance or observance of its indemnity obligations under the Oberland Purchase Agreement; • the failure by Genentech to pay material amounts owed under the Genentech collaboration agreement because of an actual breach or default by Curis under the Genentech collaboration agreement; • the failure of the security agreement to create a valid and perfected first priority security interest in any of the collateral; • a material breach or default by Curis under our agreement with Curis Royalty pursuant to which we transferred our rights to the royalty revenues under the Genentech collaboration agreement to Curis Royalty; • the voluntary or involuntary commencement of bankruptcy proceedings by either Curis or Curis Royalty and other insolvency related events; • any materially adverse effect on the binding nature of any of the Oberland Purchase Agreement, security agreement, pledge agreement or other transaction documents, the Genentech collaboration agreement or our agreement with Curis Royalty; • any person shall be designated as an independent director of Curis Royalty other than in accordance with Curis Royalty’s limited liability company operating agreement; or • Curis shall at any time cease to own, of record and beneficially, 100% of the equity interests in Curis Royalty.
Upon the occurrence and continuance of an event of default under the security agreement, the Agent may exercise its rights and remedies under the security agreement with respect to Curis Royalty and to the collateral pledged thereunder, including, among other things, acceleration of the obligations under the security agreement, the sale or other realization of the collateral and performance of Curis Royalty’s obligations under the purchase and sale agreement that we entered into in 2012 with Curis Royalty pursuant to which we transferred to Curis Royalty rights to certain royalty and royalty-related payments owed by Genentech to us under our collaboration agreement with Genentech.
Additionally, Curis granted to the Agent a first priority lien and security interest of Curis’ equity interest in Curis Royalty pursuant to a pledge agreement.
Upon the occurrence and continuance of an event of default under the security agreement, the Agent may exercise its rights and remedies under the pledge agreement with respect to the equity interests, including, among other things, the rights to receive distributions and exercise voting rights with respect to the equity interests and to sell or otherwise realize upon the collateral in satisfaction of the obligations.
The exercise by the Agent of the foregoing rights shall be deemed to constitute an exercise by the Purchasers of their put option under the Oberland Purchase Agreement.
If any of the above events of default were to occur, Curis Royalty may not have sufficient funds to pay the Put/Call Price and the Agent could foreclose on the secured royalty and royalty related payment stream and/or our equity interests in Curis Royalty.
In such an event, we could lose our right to royalty and royalty related payments not transferred to the Purchasers pursuant to the Oberland Purchase Agreement and we could lose our rights in Curis Royalty.
In addition, in the event Genentech exercises its set-off rights against royalty payments to Curis Royalty pursuant to our collaboration agreement with Genentech, Curis Royalty may be required to satisfy its royalty-sharing obligations to the Purchasers with amounts from its working capital.
The Oberland Purchase Agreement also contains exculpation and indemnification obligations of Curis and Curis Royalty on behalf of the Agent and the Purchasers.
Further, the encumbrance of all of Curis Royalty’s assets, including the right to royalties from sales of Erivedge, and our equity interests in Curis Royalty pursuant to the security agreement and pledge agreement, respectively, may inhibit us from raising additional funds or entering into other strategic arrangements.
Any of these consequences of an event of default could have a material adverse effect on our business, financial condition and stock price, including our ability to continue as a going concern.
In March 2023, Curis and Curis Royalty received a letter from counsel to Oberland Capital Management, LLC, the Purchasers and the Agent alleging defaults under Sections 4.04 and 6.04(b) of the Oberland Purchase Agreement and demanding cure of the asserted default under Section 6.04(b) of the Oberland Purchase Agreement, which each such alleged default separately entitles the Purchasers to exercise the put option, which would require Curis Royalty to repurchase the Purchased Receivables at the Put/Call Price.

and 163 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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