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Curis — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Reported a net loss of $8.1 million ($1.94 per share) for the quarter ended September 30, 2026, compared to a net loss of $7.7 million ($9.86 per share) in the same period in 2025.
    • Reported a net loss of $40.9 million ($16.77 per share) for the nine months ended September 30, 2026, compared to a net loss of $26.9 million ($43.82 per share) for the same period in 2025.
    • Reported zero revenue for the quarter and nine months ended September 30, 2026, following the sale of Erivedge royalties in Q4 2025; revenue was $3.2 million and $8.3 million for the quarter and year ended September 30, 2025, respectively.
    • Research and development expenses were $5.6 million for the quarter (down from $6.4 million in 2025) and $18.8 million for the nine months (down from $22.4 million in 2025), driven by lower employee costs offset by higher clinical costs.
    • General and administrative expenses were $3.2 million for the quarter (down from $3.7 million in 2025) and $11.4 million for the nine months (up from $11.2 million in 2025), driven by lower employee costs offset by higher legal costs.
    • Other income was $0.6 million for the quarter, compared to other expense of $0.8 million in 2025; other expense was $10.7 million for the nine months, compared to $1.6 million in 2025.
    • Cash and cash equivalents totaled $5.0 million as of September 30, 2026, with approximately 4.1 million shares of common stock outstanding.
  • Guidance and Future Outlook:

    • Initial data from the TakeAim CLL study is expected in December 2026.
    • The Company believes existing cash of $5.0 million, combined with approximately $7.5 million in net proceeds from the October 2026 Private Placement, will fund operations into the first quarter of 2027.
    • The Company explicitly states it does not have sufficient cash on hand to support current operations for the next 12 months from the date of the press release and will require substantial additional funding to advance emavusertib through regulatory approval and commercialization.
  • Business Segments and Product Lines:

    • Enrolling patients in the TakeAim CLL study (CA-4948-203), an open-label Phase 2 study of emavusertib combined with zanubrutinib in CLL patients who have received zanubrutinib for at least 12 months and have measurable residual disease; 12 patients enrolled to date.
    • Enrolling patients in the TakeAim Lymphoma study (CA-4948-101), a registrational study of emavusertib combined with ibrutinib in Relapsed/Refractory PCNSL.
    • Received FDA and EMA guidance in 2025 that the ongoing registrational study could support regulatory applications for accelerated approval in R/R PCNSL.
    • Updated clinical data (as of July 1, 2026) showed a 100% Objective Response Rate (ORR) for evaluable BTK-naïve patients (5 of 5) and 86% ORR for all BTK-naïve patients (6 of 7).
    • Updated clinical data showed a 33% ORR for evaluable BTKi-experienced patients (10 of 30) and 26% ORR for all BTKi-experienced patients (10 of 39).
    • Monotherapy and combination studies in AML are substantially complete; the Company plans to continue development in AML with additional funding.
    • Emavusertib holds Orphan Drug Designation from the FDA for PCNSL, AML, and MDS, and from the European Commission for PCNSL.
  • Market and Competitive Landscape:

    • The therapeutic strategy targets NF-kB dysregulation driven by BCR and TLR pathways, aiming for dual blockade by combining emavusertib (TLR inhibitor) with BTK inhibitors (BCR pathway blockers).
    • In R/R PCNSL, outcomes for salvage-line patients (those who progressed on BTKi) are generally poor, with many proceeding to hospice; initial data suggests adding emavusertib can reverse progression and achieve objective response.
    • In CLL, while zanubrutinib achieves 93% objective response, only 7% achieve complete response; adding emavusertib aims to enable deeper responses including undetectable minimal residual disease.
  • Risks and Challenges:

    • The Company faces substantial competition and risks related to potential adverse regulatory decisions by the FDA, EMA, and other authorities.
    • There is a risk that drug candidates may cause unexpected toxicities, fail to demonstrate safety and efficacy, or fail to achieve necessary regulatory approvals.
    • The Company is dependent on the success of emavusertib; delays in development could materially adversely affect the business.
    • There is no guarantee that the collaboration with Aurigene or the CRADA with NCI will continue for their full terms or that sufficient financial resources will be maintained.
    • The Company may not obtain or maintain necessary patent protection, potentially leading to litigation.
    • The Company faces risks regarding its ability to regain and maintain its listing on the Nasdaq Capital Market.
  • Management Commentary and Tone:

    • CEO James Dentzer expressed encouragement regarding progress in the TakeAim CLL and TakeAim Lymphoma studies.
    • Management highlighted excitement among clinicians and patients regarding the unmet need in CLL and PCNSL and the potential for emavusertib to change the treatment landscape when combined with approved BTK inhibitors.
  • Other Key Points:

    • Completed a public offering in August 2026 and a private placement in October 2026 to extend cash runway into 2027.
    • Sold Erivedge royalties to Oberland in the fourth quarter of 2025, resulting in zero revenue for the current period.
    • The Company has exclusive license rights to emavusertib (CA-4948) through a 2015 collaboration with Aurigene Discovery Technologies Limited.
    • Conference call and webcast were scheduled for November 12, 2026, at 4:30 p.m. ET.
Company
CURIS INC
Sector
Healthcare
Industry
Biotechnology