Curis, Inc. (CRIS) Bundle
As a seasoned investor, when you look at Curis, Inc. (CRIS), a clinical-stage biotechnology company, do you see a high-risk royalty play or a potential oncology breakthrough?
The company operates on a razor's edge, reporting a trailing twelve-month revenue of approximately $11.65 million, largely from Erivedge® royalties, while still posting a Q3 2025 net loss of $7.7 million, which is a common profile for a business focused on drug development.
But the real value hinges on its lead asset, emavusertib, an IRAK4 inhibitor, which recently showed a promising 50% MRD conversion rate in a July 2025 data cut-off for its AML triplet study, a critical clinical milestone that could dramatically change its valuation.
So, how does a biotech with a small $9.1 million cash position (as of September 30, 2025) manage to drive such significant, potentially life-saving clinical progress, and what does this mean for its future ownership and revenue streams?
Curis, Inc. (CRIS) History
Given Company's Founding Timeline
Curis, Inc. has a foundational history rooted in early biotechnology innovation, though its current form reflects a significant evolution over three decades. The company's story begins with an initial focus on drug discovery, long before its current pipeline of oncology therapeutics became the main driver.
Year established
The company was founded in 1991, originally operating under the name Ontogeny.
Original location
Curis, Inc. was first established in Cambridge, Massachusetts, a key hub for biotech and pharmaceutical research.
Founding team members
The initial founding team included Christoph Westphal and Michael Galler.
Initial capital/funding
Initial funding was secured from major venture capital firms, including Polaris Partners and Venrock, providing the capital necessary to start its drug discovery programs.
Given Company's Evolution Milestones
The company's trajectory is a classic biotech narrative: early promise, a major partnership, a key approval, and a necessary pivot to stay relevant. Here's the quick math on their journey, leading to the current focus on Emavusertib.
| Year | Key Event | Significance |
|---|---|---|
| 1991 | Company Founded (as Ontogeny) | Established the foundation as a biotechnology firm focused on drug discovery. |
| 2003 | FDA Approval of Vismodegib (Erivedge) | First FDA-approved drug based on Curis's hedgehog pathway inhibitor platform, licensed to Genentech/Roche, providing a crucial revenue stream via royalties. |
| 2015 | Strategic Pivot to Immuno-Oncology and Aurigene Collaboration | Shifted core focus to developing therapies that harness the immune system; secured the exclusive license for Emavusertib (CA-4948). |
| 2023 | Emavusertib Partial Clinical Hold | FDA placed a partial clinical hold on Emavusertib trials due to safety concerns, forcing a temporary reassessment of the development strategy. |
| 2025 | Q3 Clinical Progress and Financial Update | Reported a nine-month net loss of $26.9 million but announced progress in the TakeAim Lymphoma study, which is expected to support accelerated approval submissions in the US and Europe. |
Given Company's Transformative Moments
Two decisions fundamentally shaped Curis, Inc. into the clinical-stage oncology company you see today. The first was the successful development and licensing of Erivedge, and the second was the strategic shift toward a new class of targeted therapies.
The 2003 FDA approval of Erivedge (Vismodegib) was the initial game-changer. It validated Curis's discovery platform and established a long-term royalty revenue stream from Genentech/Roche, which is still a primary source of the company's revenue, totaling $8.3 million for the first nine months of the 2025 fiscal year.
The second major transformation was the 2015 strategic pivot and collaboration with Aurigene Discovery Technologies Limited. This move shifted the company's pipeline focus from the Hedgehog pathway to novel immuno-oncology and precision oncology targets, most notably the development of Emavusertib (CA-4948), an IRAK4 inhibitor. This is a high-risk, high-reward strategy. To be fair, this focus drives the majority of their spending, with Research and Development expenses reaching $22.4 million for the first nine months of 2025.
The company's current direction is defintely defined by its commitment to Emavusertib, especially after the 2023 clinical hold. They are now focused on enrolling patients in studies like TakeAim Lymphoma, aiming for accelerated regulatory filings. Still, with a market capitalization of only $18.2 million as of early November 2025, the market is pricing in significant risk, and the company has only $9.1 million in cash and equivalents, necessitating a need to raise additional capital soon. You can read more about their current strategic goals here: Mission Statement, Vision, & Core Values of Curis, Inc. (CRIS).
Curis, Inc. (CRIS) Ownership Structure
Curis, Inc. features a mixed ownership structure, typical for a clinical-stage biotechnology company, where institutional investors hold a significant stake, but the majority of shares are held by retail investors. This structure means the company's strategic direction is influenced by large fund managers, but its stock price can be defintely volatile due to the high retail float.
Curis, Inc.'s Current Status
Curis, Inc. is a publicly traded company, listed on the NASDAQ Capital Market under the ticker symbol CRIS. This status subjects the company to rigorous reporting and transparency requirements from the U.S. Securities and Exchange Commission (SEC), which is good for you as an investor. As of November 2025, the company's market capitalization stands at approximately $17.19 Million USD, reflecting its status as a smaller-cap biotech focused on developing its lead oncology asset, emavusertib. Breaking Down Curis, Inc. (CRIS) Financial Health: Key Insights for Investors
Curis, Inc.'s Ownership Breakdown
The ownership structure shows a clear distribution between professional money managers, company insiders, and the general public. This breakdown is crucial because institutional holders often signal confidence, while insider holdings align management's interests with shareholders'.
Here's the quick math for the ownership split based on the latest filings near November 2025:
| Shareholder Type | Ownership, % | Notes |
|---|---|---|
| Institutional Investors | 29.97% | Includes mutual funds and hedge funds like Bleichroeder LP and Armistice Capital, Llc. |
| Company Insiders | 5.45% | Shares held by officers and directors, which is a relatively small percentage. |
| Retail Investors (Public) | 64.58% | The remaining float held by individual investors (100% minus 29.97% and 5.45%). |
Curis, Inc.'s Leadership
The company is steered by a focused executive team with deep experience in drug development, which is exactly what you want to see in a clinical-stage biotech. The leadership's primary focus is the advancement of their key pipeline candidates, specifically the IRAK4 inhibitor, emavusertib.
The core executive team as of November 2025 includes:
- James Dentzer: President and Chief Executive Officer (CEO)
- Diantha Duvall: Chief Financial Officer (CFO)
- Ahmed Hamdy, MBBCH: Chief Medical Officer (CMO)
- Robert Martell, M.D., Ph.D.: Chief Scientific Officer (CSO)
- Jonathan Zung, Ph.D.: Chief Development Officer (CDO)
This team is currently managing the push for accelerated approval filings for emavusertib in Primary CNS Lymphoma (PCNSL) in both the US and EU, a major near-term catalyst. Their decisions will directly impact the cash runway, which was projected to extend only into the first quarter of 2026 as of September 30, 2025.
Curis, Inc. (CRIS) Mission and Values
Curis, Inc.'s core purpose transcends typical profit motives, focusing instead on developing first-in-class cancer therapeutics to fundamentally improve patient outcomes. This mission is a high-stakes endeavor, as evidenced by the company's research and development (R&D) expenses of $22.4 million for the first nine months of 2025, which dwarfs their $8.3 million in revenue from royalties in the same period.
Curis, Inc.'s Core Purpose
You're looking at a company whose very existence is tied to clinical success, so their mission isn't just a marketing line; it's the engine driving their cash burn. They are a pure-play biotechnology firm, meaning their cultural DNA is built around scientific innovation and patient impact, not just incremental market share. Exploring Curis, Inc. (CRIS) Investor Profile: Who's Buying and Why?
Official Mission Statement
Curis's mission is clearly centered on oncology, aiming to bring innovative drug candidates from the lab to market to transform the lives of cancer patients. This focus is narrow, but defintely deep.
- Develop and commercialize innovative therapeutics in oncology.
- Commit to making a tangible difference in the lives of cancer patients.
- Focus on novel and innovative drug candidates like emavusertib (an IRAK4 inhibitor).
Vision Statement
While a single, formal vision statement isn't always published, Curis's strategic communication paints a clear picture: they aim to disrupt the current standard of care in hematologic malignancies. They are not satisfied with partial responses (PRs) from existing treatments.
- Improve upon the current standard of care in cancer treatment.
- Enable patients to achieve deeper, more durable responses, potentially coming off chronic treatment.
- Change the treatment paradigm for patients with conditions like Chronic Lymphocytic Leukemia (CLL) and Primary Central Nervous System Lymphoma (PCNSL).
Here's the quick math on the risk: as of September 30, 2025, Curis held only $9.1 million in cash and equivalents, so their vision requires significant capital raises to fund the clinical trials necessary to realize it.
Curis, Inc. Tagline/Core Focus
The company's most consistent, action-oriented statement reflects its developmental stage and its ultimate goal for its pipeline drug, emavusertib.
- Developing differentiated therapeutics with the goal of improving the lives of cancer patients.
This focus shows they are not just developing a me-too drug; they are targeting a novel mechanism of action (IRAK4 inhibition) to overcome adaptive resistance to current therapies.
Curis, Inc. (CRIS) How It Works
Curis, Inc. operates as a clinical-stage biotechnology company focused on developing novel cancer therapies by targeting key signaling pathways involved in tumor growth and immune evasion. Their core business model is to discover and advance proprietary drug candidates, primarily emavusertib, through clinical trials for hematologic malignancies and then pursue regulatory approval and commercialization, often through strategic licensing partnerships.
This is a high-stakes, high-reward drug development game.
Curis, Inc.'s Product/Service Portfolio
| Product/Service | Target Market | Key Features |
|---|---|---|
| Emavusertib (CA-4948) | Relapsed/Refractory Hematologic Malignancies (PCNSL, AML, hrMDS) | Orally available, small molecule inhibitor of IRAK4 and FLT3; currently in Phase 1/2 clinical trials (TakeAim Lymphoma/Leukemia); holds U.S. and E.U. Orphan Drug Designation for PCNSL. |
| Erivedge® (vismodegib) | Advanced Basal Cell Carcinoma | Approved, first-in-class Hedgehog pathway inhibitor; licensed to Genentech (a member of the Roche Group); generates royalty revenue for Curis, Inc. |
Curis, Inc.'s Operational Framework
The company's operational framework is centered on a lean, oncology-focused research and development (R&D) model, leveraging external partnerships for discovery and commercialization to manage capital expenditure. For the nine months ended September 30, 2025, Curis, Inc. reported R&D expenses of approximately $22.4 million, a decrease from the prior year, reflecting a disciplined focus on their lead candidate, emavusertib.
- Drug Discovery & Licensing: Curis, Inc. secures exclusive rights to promising compounds, like emavusertib from Aurigene Discovery Technologies Limited, to build its proprietary pipeline.
- Clinical Development: The primary operational focus is executing the Phase 1/2 TakeAim clinical trials for emavusertib across multiple indications, including Primary Central Nervous System Lymphoma (PCNSL) and Acute Myeloid Leukemia (AML).
- Regulatory Strategy: They are actively enrolling patients in the PCNSL cohort of the TakeAim Lymphoma study to generate data that could enable accelerated approval filings in the U.S. and E.U.
- Revenue Generation: Value is realized through milestone payments and royalty revenues from commercialized, licensed assets, such as Erivedge®. Total revenues for the nine months ended September 30, 2025, were $8.3 million, derived entirely from these royalties.
Their model translates scientific breakthroughs into clinical assets, then partners to commercialize.
Curis, Inc.'s Strategic Advantages
Curis, Inc.'s market success hinges on a few clear advantages that differentiate its pipeline and financial structure in the competitive biotech sector. They've built a defintely smart, two-pronged approach.
- First-in-Class IRAK4 Inhibition: Emavusertib is positioned as a first-in-class, orally available inhibitor of Interleukin-1 Receptor-Associated Kinase 4 (IRAK4), a novel oncology target with potential in multiple hematologic and solid tumors.
- Accelerated Regulatory Pathway: The drug has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for PCNSL, AML, and MDS, which can expedite development and review, plus provide market exclusivity upon approval.
- De-Risked Revenue Stream: The existing licensing agreement with Genentech for Erivedge® provides a non-dilutive source of funding-the $8.3 million in revenue for the first nine months of 2025-to partially offset the net loss of $26.9 million for the same period.
- Strategic Collaboration Model: Licensing in compounds (like emavusertib from Aurigene) and licensing out approved drugs (like Erivedge® to Genentech) allows Curis, Inc. to focus its limited capital on high-value clinical development while sharing the financial burden and commercial risk.
To understand the company's long-term vision, review the Mission Statement, Vision, & Core Values of Curis, Inc. (CRIS).
Curis, Inc. (CRIS) How It Makes Money
Curis, Inc. has historically generated its revenue primarily as a royalty-based business, collecting payments from its licensed drug, Erivedge (vismodegib), while operating as a development-stage biotechnology company focused on advancing its proprietary oncology pipeline, led by emavusertib (CA-4948). However, this model fundamentally changed in November 2025 with the sale of its core royalty asset, meaning its future revenue will depend entirely on collaboration agreements and milestone payments from its pipeline development.
Curis, Inc.'s Revenue Breakdown
For the first nine months of the 2025 fiscal year, Curis's revenue was almost entirely derived from a single source, but this structure is now obsolete. The company reported total revenue of $8.3 million for the nine months ended September 30, 2025, which was a slight increase from the $7.6 million in the same period in 2024. This revenue came exclusively from royalties.
| Revenue Stream | % of Total (9M 2025) | Growth Trend |
|---|---|---|
| Erivedge Royalty Revenue (Genentech/Roche) | ~100% | Decreasing to Zero (Sold Nov 2025) |
| Collaboration/Milestone Revenue | ~0% | Increasing (Future Model Reliance) |
Business Economics
The economic reality for Curis has just seen a massive pivot. For years, the company's sole, reliable income stream was the Erivedge royalty, which came from its partner Genentech, a member of the Roche Group, for sales of the basal cell carcinoma treatment. That revenue stream, which brought in $3.2 million in Q3 2025 alone, is now gone.
On November 6, 2025, Curis sold its remaining interest in the Erivedge royalty stream for $2.5 million in upfront cash. The real win here wasn't the cash, but the extinguishment of a related liability from a prior sale of future royalties, which stood at $28.6 million as of September 30, 2025. That move significantly shored up the balance sheet to meet NASDAQ listing requirements, but it also made Curis a pure-play, pre-commercial biotech. It's a high-risk, high-reward bet on the pipeline.
- Pure-Play Focus: The entire business now hinges on the clinical success of its lead asset, emavusertib, an oral IRAK4 and FLT3 inhibitor in trials for cancers like Primary Central Nervous System Lymphoma (PCNSL) and Acute Myeloid Leukemia (AML).
- Future Revenue Model: Revenue will shift from predictable royalties to lumpy, high-value payments: upfront payments, milestone payments, and future royalties from new licensing deals if emavusertib or other pipeline candidates are successfully partnered or commercialized.
- Pricing Strategy: As a drug developer, Curis does not set the price for Erivedge; Genentech/Roche does. The future pricing strategy for emavusertib, should it reach market, will be based on its value as a novel oncology agent, likely commanding a premium price typical of specialty cancer therapeutics.
You can find more on the company's long-term goals here: Mission Statement, Vision, & Core Values of Curis, Inc. (CRIS).
Curis, Inc.'s Financial Performance
Curis's financial health is typical of a clinical-stage biotech: high operating burn funded by equity and asset sales, not product revenue. The Q3 2025 results show a company aggressively managing costs while burning cash to fund its critical clinical programs.
- Net Loss: The net loss for the third quarter of 2025 was $7.7 million, an improvement from the $10.1 million loss in Q3 2024. The nine-month net loss was $26.9 million.
- R&D Expense: Research and Development (R&D) expenses are the primary operating cost, reflecting the clinical trial focus. R&D decreased significantly to $6.4 million in Q3 2025, down from $9.7 million in the prior year period, showing a clear focus on cost control.
- Cash Position and Runway: As of September 30, 2025, cash and cash equivalents totaled $9.1 million. Management expects this cash to fund operations only into the first quarter of 2026, meaning a significant capital raise or partnership is defintely required in the immediate near-term.
- Stockholders' Deficit: The company's stockholders' deficit increased to $14.7 million as of September 30, 2025, compared to $6.0 million at the end of 2024, highlighting the cumulative losses. The November 2025 royalty sale is a direct action to address this deficit and the NASDAQ compliance issue.
Curis, Inc. (CRIS) Market Position & Future Outlook
Curis, Inc. is positioned as a high-risk, high-reward niche player in hematologic oncology, with its future hinged entirely on the clinical success and regulatory path of its lead candidate, emavusertib (CA-4948). The company's near-term goal is to secure a path to accelerated approval for emavusertib in Primary Central Nervous System Lymphoma (PCNSL), a small but high-value market, while simultaneously managing a tight cash position.
Competitive Landscape
In the hematology space, Curis is not competing on volume but on mechanism of action. Emavusertib is a dual IRAK4 and FLT3 inhibitor, targeting specific mutations and resistance pathways where the established players often fail. This is a battle for therapeutic superiority in specific, high-unmet-need patient populations, not a fight for broad market share.
| Company | Market Share, % | Key Advantage |
|---|---|---|
| Curis, Inc. | <1% (Royalty-based) | Dual IRAK4/FLT3 inhibition; Potential for accelerated approval in PCNSL |
| AbbVie/Janssen (Imbruvica) | <38.9% (CLL/SLL segment) | Established first-in-class BTK inhibitor; Broad label and physician familiarity |
| Astellas Pharma (Xospata) | N/A (Dominant FLT3 inhibitor in a $599.3M market) | Approved, targeted therapy for relapsed/refractory FLT3-mutated AML |
Opportunities & Challenges
The opportunity for Curis is clear: a first-mover advantage in a niche indication like PCNSL, plus a potentially superior drug profile in Acute Myeloid Leukemia (AML). But still, the entire biotech model means cash is always a concern until a drug is approved and generating significant revenue.
| Opportunities | Risks |
|---|---|
| Accelerated Approval for Emavusertib in PCNSL: FDA/EMA discussions support potential accelerated submission, creating a path to market. | Cash Runway/Funding: Cash of only $9.1 million (Q3 2025) is expected to fund operations into 2026, requiring a dilutive capital raise before year-end. |
| Superior Clinical Differentiation in AML: Emavusertib shows a 38% composite complete remission (CR) rate in FLT3-mutant AML, significantly higher than Gilteritinib's 21%. | Dose-Limiting Toxicities (DLTs): DLTs observed in the AML triplet study, which could impact the optimal dosing regimen and delay trial progression. |
| Pipeline Expansion in CLL: Initiating a Phase 2 study in Chronic Lymphocytic Leukemia (CLL) to achieve deeper responses with BTKi combination. | Competitive Pressure from Next-Gen Inhibitors: Facing competition from newer BTK and FLT3 inhibitors with potentially better safety or selectivity profiles. |
Industry Position
Curis operates as a pure-play clinical-stage oncology firm, meaning its valuation is defintely tied to binary clinical and regulatory events rather than commercial sales. The company's revenue for the full 2025 fiscal year is projected by analysts to be around $144.9 million, but this is a highly volatile forecast that assumes significant milestones, as Q3 2025 revenue was only $3.2 million from existing Erivedge royalties.
The core of their value is their IRAK4 inhibition platform, which targets a novel pathway in certain hematologic cancers. You should view their position as a potential acquisition target for a larger pharma company looking to quickly enter the IRAK4 space, assuming the clinical data continues to impress.
- Focus efforts on accelerating PCNSL enrollment to meet accelerated approval timelines.
- Initial data from the frontline AML triplet study is expected at the ASH annual meeting in December 2025, which will be a critical near-term catalyst.
- The long-term strategy hinges on successfully translating the IRAK4/FLT3 mechanism into multiple approved indications.
For a deeper dive into the company's foundational principles, you can review their Mission Statement, Vision, & Core Values of Curis, Inc. (CRIS).

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