CURIS INC

Curis, Inc. is a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule inhibitor of Interleukin-1 receptor associated kinase (IRAK4) and FMS-like tyrosine kinase 3 (FLT3). The company operates in the highly competitive and rapidly evolving human therapeutics industry, specifically targeting cancers through the inhibition of signaling pathways. The industry is characterized by intense competition from large pharmaceutical and specialized biotechnology firms, with many competitors having substantially greater research, development, manufacturing, marketing, and financial capabilities. The company's position within this landscape is that of a clinical-stage developer with a single lead drug candidate, emavusertib, which is still in early clinical development.

The filing names numerous primary competitors for emavusertib across its target indications. For IRAK4 inhibitors, competitors 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 (AZD2962), Hangzhou Polymed Biopharmaceuticals (HPB-092 – IRAK4 / FLT3), and Eilean Therapeutics (lomonitinib – IRAK4 / FLT3). For frontline CLL in combination with a BTK inhibitor, competitors include BeOne Medicines (zanubrutinib in combination with venetoclax) and AbbVie Inc. together with Johnson & Johnson (ibrutinib in combination with venetoclax). For PCNSL in combination with a BTK inhibitor, competitors include Bayer AG (copanlisib in combination with ibrutinib). For AML with a FLT3 mutation, competitors include Astellas Pharma, Inc. (gilteritinib), Daiichi Sankyo (quizartinib), Jiangsu Hengrui (famitinib malate), and Novartis (midostaurin). The company's stated competitive advantages are not explicitly quantified in the filing, but its moat is implied through its intellectual property portfolio, including 52 issued or allowed U.S. patents as of December 31, 2025 ¹, and its exclusive license to emavusertib through its collaboration with Aurigene.

The company generates revenue through a business model centered on the research and development of drug candidates, with a primary focus on emavusertib. Historically, revenue was derived from royalty payments on net sales of Erivedge under a collaboration with Genentech, but following the sale of Erivedge in November 2025, the company is no longer entitled to revenues under the Genentech License Agreement. The company does not expect to generate any revenues for several years, if ever, and its future revenue generation is entirely dependent on the successful development, regulatory approval, and commercialization of emavusertib. The company has no sales, marketing, or distribution experience or infrastructure and relies on third parties for manufacturing and clinical trial conduct. Its primary customer segments are not yet defined as it has no commercial products, but its clinical focus is on patients with hematologic malignancies such as PCNSL, CLL, and AML.

The company's sole drug candidate is emavusertib (CA-4948), an orally available, small molecule inhibitor of IRAK4 and FLT3. It is currently being evaluated in two clinical studies: the TakeAim Lymphoma Phase 1/2 study (CA-4948-101) in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) in combination with ibrutinib, and the recently initiated TakeAim CLL study, a Phase 2 combination study of emavusertib in chronic lymphocytic leukemia (CLL) with zanubrutinib. The company's monotherapy and combination studies of emavusertib in AML are substantially complete. Emavusertib has received Orphan Drug Designation from the FDA for the treatment of PCNSL, AML and MDS and from the European Commission for the treatment of PCNSL. The company also has licensed programs under its collaboration with Aurigene, including the IRAK4 program (emavusertib), the PD1/TIM3 program (development candidate CA-327), and an immuno-oncology program. For each of these licensed programs, the company has remaining unpaid or unwaived payment obligations of $42.5 million per program ², related to regulatory approval and commercial sales milestones, plus specified additional payments for approvals for additional indications.

In November 2025, the company sold its 100% interest in Curis Royalty LLC to TPC Investments Royalty LLC, which included the Erivedge intellectual property and the Genentech License Agreement, in exchange for upfront consideration of $2.5 million ³ and a release of its liability related to the sale of future royalties to Oberland. In January 2026, the company completed a private placement (January 2026 PIPE Financing) for net proceeds of approximately $18.6 million ⁴. During the fiscal year, the company completed the March 2025 Offerings and the July 2025 Offerings, receiving net proceeds of approximately $8.8 million ⁵ and approximately $6.1 million ⁶, respectively. The company also entered into an amended and restated sales agreement in February 2024 to sell up to $100.0 million ⁷ shares of common stock through an at-the-market offering program, though no shares were sold under this agreement during the year ended December 31, 2025.

For the year ended December 31, 2025, the company reported a net loss of $7.6 million ⁸, 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 ⁹. This compares to a net loss of $43.4 million ¹⁰ for the year ended December 31, 2024. Revenues, net decreased by 13% ¹¹ to $9.4 million ¹² from $10.9 million ¹³ in the prior year, primarily due to the sale of Erivedge. Research and development expenses decreased by 27% ¹⁴ to $28.3 million ¹⁵ from $38.6 million ¹⁶, and general and administrative expenses decreased by 16% ¹⁷ to $14.0 million ¹⁸ from $16.8 million ¹⁹. As of December 31, 2025, the company had an accumulated deficit of $1.2 billion ²⁰ and cash and cash equivalents of $5.1 million ²¹. The company used $27.2 million ²² of cash in operations during the year.

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A primary growth vector is the development of emavusertib for the treatment of relapsed/refractory PCNSL through the ongoing TakeAim Lymphoma Phase 1/2 study. The company has completed productive meetings with both the European Committee for Medicinal Products for Human Use (CHMP) and the FDA on the suitability of using this study to support a potential accelerated regulatory path. For a Conditional Marketing Authorization (CMA) submission in Europe, the CHMP indicated that 45 patients ²³ may be sufficient to support a CMA, assuming compelling and consistent results. For a New Drug Application (NDA) submission in the U.S. for Accelerated Approval, the FDA indicated that the current single-arm study could support a submission, with Overall Response Rate (ORR) supported by adequate duration of response potentially being acceptable. Both regulators encouraged continued discussions to align on the confirmatory study design, which is required prior to submission.

A second major growth vector is the recently initiated TakeAim CLL study, a Phase 2 open label clinical study of emavusertib in combination with zanubrutinib in frontline CLL (CA-4948-203). The company began activating sites during the fourth quarter of 2025 and expects to initiate dosing during the first half of 2026, with initial data expected in the fourth quarter of 2026. This represents an expansion of the clinical program into a new, large indication. The company also plans to continue development of emavusertib in AML with additional funding, as its monotherapy and combination studies in AML are substantially complete.The company expects research and development expenses to increase substantially over the next several years as it conducts larger clinical trials and prepares regulatory filings. General and administrative expenses decreased by 16% ²⁴ in 2025 compared to 2024, primarily due to lower employee-related, legal, insurance, consulting, and facility costs.

The company's operational outlook is focused on executing its clinical development plans for emavusertib. It relies on third parties, including contract research organizations (CROs) and contract manufacturing organizations (CMOs), to conduct clinical trials and manufacture its drug candidate. The company does not have its own manufacturing capabilities and has no plans to develop them. As of February 9, 2026, the company had 24 employees ²⁵, of which 20 are full-time ²⁶ and 14 are involved in research and development ²⁷. The company occupies approximately 21,772 feet ²⁸ of office and laboratory space in Lexington, Massachusetts under a lease that will expire on April 30, 2027.

The company's capital allocation strategy is focused on funding its research and development program for emavusertib. Research and development expenses for the year ended December 31, 2025 were $28.3 million ²⁹. The company does not have a disclosed capital expenditure plan. It has an at-the-market offering program under which it can sell up to $100.0 million ³⁰ shares of common stock, though sales are restricted when its public float is under $75.0 million ³¹. The company has never declared or paid any cash dividends on its common stock and does not anticipate paying cash dividends in the foreseeable future.

A significant headwind is the company's financial condition, which raises substantial doubt about its ability to continue as a going concern. As of December 31, 2025, the company had only $5.1 million ³² in cash and cash equivalents. While the January 2026 PIPE Financing provided net proceeds of approximately $18.6 million ³³, the company concluded it does not have sufficient cash on hand to support current operations beyond the next 12 months from the date of filing. The company has faced and expects to continue to face substantial difficulties in raising capital. If sufficient funds are not available, it will have to delay, reduce the scope of, or eliminate its research and development program for emavusertib.

A key execution risk is the company's dependence on the success of emavusertib, which is still in early clinical development. Clinical trials may not be successful, and the company has never obtained marketing approval for a drug candidate. The company also faces substantial competition from companies with greater resources. Additionally, the company relies on third parties to conduct clinical trials and manufacture its drug candidate, and any failure by these parties could delay development. The company's ability to maintain its listing on the Nasdaq Capital Market is also a constraint, as it has previously received deficiency letters and is subject to a discretionary panel monitor for a period of one-year.

The most material risk is the substantial doubt about the company's ability to continue as a going concern, as it had only $5.1 million ³⁴ in cash as of December 31, 2025, and expects to continue incurring operating losses. A second critical risk is the company's heavy dependence on the success of emavusertib, which is still in early clinical development and may not be successfully commercialized. Third, the company faces intense competition from companies with substantially greater resources, including those developing IRAK4 inhibitors, BTK inhibitor combinations for CLL and PCNSL, and FLT3 inhibitors. Fourth, the company relies on third parties to conduct clinical trials and manufacture its drug candidate, and any failure by these parties could delay development. Finally, the company has never obtained marketing approval for a drug candidate and may be unable to obtain, or may be delayed in obtaining, marketing approval for emavusertib, which would prevent it from generating revenue.

Management's message emphasizes a strategic focus on the development of emavusertib, specifically prioritizing the ongoing combination Phase 1/2 study in relapsed/refractory PCNSL with ibrutinib and the recently initiated Phase 2 combination study in CLL with zanubrutinib. The tone is one of cautious optimism, highlighting productive regulatory meetings with both the CHMP and FDA that support a potential accelerated regulatory path for emavusertib in PCNSL. Key forward-looking statements include the expectation to initiate dosing in the TakeAim CLL study during the first half of 2026, with initial data expected in the fourth quarter of 2026. Management also notes that with additional funding, it plans to continue development of emavusertib in AML. The strategic priorities emphasized are: 1) focusing operations on the PCNSL and CLL clinical programs, 2) pursuing accelerated regulatory pathways for emavusertib in PCNSL, and 3) securing additional financing to fund operations and development, as the company has identified conditions that raise substantial doubt about its ability to continue as a going concern.