8-K: Curis Sells Erivedge Royalties, Extends Cash Runway

Curis, Inc. announced the sale of its Erivedge royalty interest for $2.5 million, extinguished a related liability, and provided a Q3 2025 business update, including clinical progress and Nasdaq listing efforts.

Summary

• Curis, Inc. sold its interest in Curis Royalty, including the Erivedge intellectual property and License Agreement, to TPC Investments Royalty LLC (managed by Oberland Capital) on November 6, 2025.
• The sale generated $2.5 million in upfront consideration and released Curis from liability related to the previous sale of future royalties to Oberland.
• Curis will recognize a gain in Q4 2025 and extinguish the liability related to the sale of future royalties, but will no longer receive Erivedge revenues.
• The company believes the Erivedge Business sale helps meet Nasdaq's $2.5 million stockholders' equity requirement, an alternative to the $35 million market value requirement, following a delisting notice received on August 21, 2025.
• Curis reported a net loss of $7.7 million ($0.49 per share) for Q3 2025, an improvement from $10.1 million ($1.70 per share) in Q3 2024.
• Revenues for Q3 2025 were $3.2 million, up from $2.9 million in Q3 2024, primarily from Erivedge royalties.
• Research and development expenses decreased to $6.4 million in Q3 2025 from $9.7 million in Q3 2024, due to lower clinical, employee, manufacturing, research, and consulting costs.
• Cash and cash equivalents totaled $9.1 million as of September 30, 2025, with approximately 12.7 million shares outstanding.
• A registered direct offering and concurrent private placement were completed, extending the cash runway into Q1 2026.
• Clinical progress for emavusertib includes ongoing enrollment in the TakeAim Lymphoma study for PCNSL, initiation of a Phase 2 CLL study (first patient late Q4 2025/early Q1 2026), and initial data from the frontline AML triplet study showing 50% MRD conversion in 4 of 8 patients.

Sentiment

Score: 4

Explanation: While there are positive clinical updates and a strategic asset sale, the immediate need for substantial capital, short cash runway, and ongoing Nasdaq delisting threat create significant financial uncertainty and risk. The clinical data, while promising, is still early-stage and for a small number of patients.

Positives

• Sale of Erivedge Business for $2.5 million upfront consideration and release from a significant liability related to future royalty sales.
• Extinguishment of the liability related to the sale of future royalties, expected to result in a gain in Q4 2025.
• The Erivedge Business sale is believed to help meet Nasdaq's alternative listing requirement of $2.5 million stockholders' equity, potentially preventing delisting.
• Improved net loss for Q3 2025 at $7.7 million, compared to $10.1 million in Q3 2024.
• Increased revenues for Q3 2025 to $3.2 million, up from $2.9 million in Q3 2024.
• Reduced R&D expenses to $6.4 million in Q3 2025 from $9.7 million in Q3 2024, reflecting cost management.
• Successful completion of a registered direct offering and concurrent private placement, extending the cash runway into Q1 2026.
• Positive clinical progress for emavusertib, including ongoing enrollment in PCNSL studies for accelerated approval filings.
• Emavusertib has received Orphan Drug Designation from both the FDA and EMA for PCNSL.
• Initial data from the frontline AML triplet study showed MRD conversion (positive to undetectable) in 4 of 8 patients (50%) and a 40% reduction in MRD in an additional patient, with no progression in MRD+ patients on study.
• Initiation of a Phase 2 clinical study of emavusertib + BTKi in CLL, with the potential for complete remission or undetectable minimal residual disease and time-limited treatment.

Negatives

• The company received a Nasdaq delisting notice on August 21, 2025, for failing to meet the $35,000,000 market value of listed securities requirement.
• The Nasdaq Hearings Panel granted an exception until November 14, 2025, to regain compliance, indicating continued uncertainty regarding listing status.
• Following the sale of the Erivedge Business, Curis will no longer be entitled to revenues under the License Agreement, eliminating a revenue stream.
• Other expense increased to $0.8 million in Q3 2025 from other income of $0.5 million in Q3 2024, primarily due to increased expense related to the sale of future royalties and decreased interest income.
• Cash and cash equivalents decreased to $9.1 million as of September 30, 2025, from $19.997 million as of December 31, 2024.
• The company's existing cash and cash equivalents are only expected to fund operations into Q1 2026, indicating a short cash runway.
• Two dose-limiting toxicities (CPK increase and neutropenia) were observed in the 14-day cohort of the AML triplet study, although both resolved.

Risks

• Adverse results, delays, and/or failures in drug development programs, potentially preventing successful advancement of drug candidates.
• Drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies, or never achieve regulatory approvals.
• Failure to achieve projected timelines for patient enrollment and regulatory filings for emavusertib in PCNSL and other indications.
• Safety and efficacy data from the TakeAim Lymphoma study in PCNSL may not be sufficient for conditional marketing authorization from the EMA or accelerated approval from the FDA.
• Favorable results from preclinical studies and early clinical trials may not be replicated in later trials.
• High dependence on the success of emavusertib, with any delays having a material adverse effect on the business.
• The collaboration agreement with Aurigene may not continue for its full term, and the CRADA with NCI may not be extended.
• Curis or its collaborators may not maintain the financial and other resources necessary to fund research, development, and commercialization costs.
• Regulatory authorities may delay or restrict Genentech's and/or Roche's ability to commercialize Erivedge.
• Development of competing drugs superior to Erivedge or the emergence of generic versions.
• Risks related to the Oberland Capital agreement, including potential loss of retained rights to future royalty payments, requirement to repurchase payments at a multiple, and inhibition of future arrangements.
• The company requires substantial additional capital to fund its business and does not have sufficient cash on hand to support current operations within the next 12 months from the date of the press release.
• Substantial additional funding is immediately required for emavusertib development through regulatory approval and commercialization, and to support continued operations.
• Failure to obtain sufficient funding will force delays, reductions in scope, or elimination of emavusertib development, including clinical trials and operating expenses.
• Substantial competition in the biotechnology industry.
• Risk of potential adverse decisions by the FDA, EMA, other regulatory authorities, investigational review boards, and publication review bodies.
• Inability to obtain or maintain necessary patent protection, leading to expensive and time-consuming patent litigation.
• Unstable market and economic conditions, natural disasters, public health crises, political crises, and other events outside of Curis's control could disrupt operations.
• Uncertainty regarding the ability to regain and maintain listing on the Nasdaq Capital Market.

Future Outlook

The company expects to enroll the first patient in its Phase 2 study of emavusertib + BTKi in CLL in late Q4 2025 or early Q1 2026, with data anticipated at the ASH annual meeting in December 2026. It continues to enroll PCNSL patients in the TakeAim Lymphoma study to support accelerated approval filings in the US and EU. The company's existing cash and cash equivalents are projected to fund operations into the first quarter of 2026. Following the sale of the Erivedge Business, the company will recognize a gain in Q4 2025 and extinguish the related liability.

Management Comments

• "I am very pleased with the progress we have made across multiple ongoing studies in PCNSL, CLL, and AML."

Industry Context

Curis operates in the highly competitive biotechnology sector, focusing on oncology drug development, specifically with its lead candidate emavusertib for various blood cancers and lymphomas. The company's strategy involves combination therapies (e.g., emavusertib + BTKi in CLL, emavusertib + aza-ven in AML) to improve upon existing standards of care, aiming for deeper responses like complete remission or undetectable minimal residual disease and potentially time-limited treatments, which could be a significant differentiator in the market. The sale of its Erivedge royalty stream indicates a strategic shift to fully focus resources on its pipeline development, a common move for smaller biotechs seeking to streamline operations and fund R&D. The ongoing Nasdaq listing challenge highlights the financial pressures faced by many development-stage biotech companies.

Legal Proceedings

• Received a notice from Nasdaq on August 21, 2025, regarding non-compliance with the $35,000,000 market value of listed securities requirement, leading to a delisting determination.
• The company timely appealed this determination and was granted an exception until November 14, 2025, by the Nasdaq Hearings Panel to regain compliance.

Related Party Transactions

• The sale of Curis Royalty (Erivedge Business) was to TPC Investments Royalty LLC, a limited liability company managed by Oberland, which was previously a party to the Royalty Interest Purchase Agreement. This constitutes a related party transaction as Oberland Capital was already involved in the Erivedge royalty stream.

Stakeholder Impact

• Shareholders face uncertainty regarding Nasdaq listing, potential dilution from future capital raises, and the loss of a recurring royalty revenue stream. However, the asset sale provides immediate cash and liability relief, potentially stabilizing the company in the short term. Clinical progress could offer long-term value.
• Employees' continued operations are dependent on successful capital raises, which could impact job security if funding is not secured.
• Customers (Patients) have the potential for new treatment options if emavusertib successfully advances through clinical trials and gains regulatory approval.
• Creditors see an improvement in the balance sheet due to the extinguishment of the liability related to the sale of future royalties, but the short cash runway and need for further funding present ongoing credit risk.

Next Steps

• File unaudited pro forma condensed consolidated financial information by amendment to the 8-K within four business days following November 6, 2025.
• Present updated PCNSL and SCNSL data at the 30th Annual Meeting of the Society for Neuro-Oncology on November 19-23, 2025.
• Regain compliance with Nasdaq's MVLS Requirement by November 14, 2025.
• Present initial clinical data from the frontline AML triplet study at the 67th ASH Annual Meeting on December 6-9, 2025.
• Enroll the first patient in the Phase 2 clinical study of emavusertib + BTKi in CLL in late Q4 2025 or early Q1 2026.
• Present initial clinical data from an Investigator Sponsored Study (IST) in pancreatic ductal adenocarcinoma (PDAC) at the ASCO Gastrointestinal Cancers Symposium on January 8-10, 2026.
• Seek substantial additional capital to fund emavusertib development and continued operations.
• Expect data from the Phase 2 CLL study at the ASH annual meeting in December 2026.

Key Dates

Recommendation

The company faces significant financial challenges, including a short cash runway and Nasdaq delisting concerns, which warrant caution. However, the strategic sale of the Erivedge royalty stream provides immediate capital and liability relief, and the clinical pipeline for emavusertib shows promising early-stage data in multiple indications. The upcoming clinical data presentations and the initiation of new studies could be catalysts. Given the high risk but also the potential for future value creation from the pipeline, a 'hold' recommendation is appropriate for investors who are comfortable with high-risk biotech investments and are awaiting further clarity on funding and clinical milestones.

Keywords

Curis Inc., CRIS, Biotechnology, Emavusertib, CA-4948, IRAK4 inhibitor, FLT3 inhibitor, PCNSL, Primary CNS Lymphoma, CLL, Chronic Lymphocytic Leukemia, AML, Acute Myeloid Leukemia, Erivedge, Vismodegib, Royalty sale, Oberland Capital, Nasdaq listing, Financial results, Clinical trials, Orphan Drug Designation, Oncology, Drug development, Biopharma