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CURIS INC

CIK: 11082051 Annual ReportsLatest: 2025-03-31

10-K / March 31, 2025

Company Overview: Curis, Inc.

Business Focus

  • Curis, Inc. is a biotechnology company specializing in the discovery and development of innovative drug candidates for the treatment of human cancers.
  • Main product candidate: emavusertib (CA-4948), an orally available small molecule inhibitor targeting IRAK4 (Interleukin-1 receptor associated kinase 4), a key component in pathways dysregulated in cancers.
  • Emavusertib is in clinical development-stage trials for various hematologic malignancies, including AML, non-Hodgkin's lymphoma, and PCNSL.

Current Products and Collaborations

  • Emavusertib (CA-4948):

    • Undergoing multiple Phase 1/2 clinical trials:
      • TakeAim Lymphoma: Testing in relapsed/refractory PCNSL combined with ibrutinib.
      • TakeAim Leukemia: Testing in AML and high-risk MDS.
      • AML Triplet Study: Add-on to azacitidine and venetoclax in AML in Europe.
    • Clinical data from trials presented in 2022–2025.
    • Received Orphan Drug Designations in 2024 from US and European regulators for PCNSL.
    • Regulatory discussions with FDA and European authorities on accelerated approval pathways.
  • Outlicensed/Partnered Programs:

    • Erivedge (vismodegib): Approved Hedgehog pathway inhibitor for basal cell carcinoma, licensed to Genentech/Roche.
    • Royalties from Erivedge are a major revenue source; paid to Curis Royalty LLC.
    • CA-170: An immune checkpoint program licensed to Aurigene, undergoing Phase 2b/3 trials.

Proprietary Technologies & Patents

  • Focus on patenting innovations related to IRAK4 inhibitors, Hedgehog pathway modulators, and immune checkpoint targets.
  • Owned or licensed numerous patents expiring between 2025 and 2042.

Revenue & Financials

  • 2024 Revenue: Approximately $10.9 million from royalties on Erivedge sales.
  • 2024 Net Loss: about $43.4 million.
  • Total accumulated deficit: $1.2 billion.
  • Cash on hand: $20.0 million as of December 31, 2024.
  • Recent financing:
    • Completed a registered direct offering and private placement in March 2025 with net proceeds of $9.0 million.
    • Planned to fund operations into Q4 2025.
  • Employees: 34 (as of December 31, 2024), with 22 involved in R&D activities.

Key Strategic and Commercial Information

  • No in-house sales or marketing infrastructure; relies on third-party partners for commercialization.
  • Development efforts are primarily funded via collaborations, licensing fees, royalties, and equity financings.
  • The company has significant financial obligations related to licensing agreements, including milestone and royalty payments.
  • Continues to seek additional capital to advance its clinical pipeline and sustain operations.

Summary

Curis, Inc. is a biotech firm primarily focused on developing IRAK4 inhibitors like emavusertib for cancers, with revenue driven mainly by royalties from the approved drug Erivedge licensed to Genentech. It operates with a small team, ongoing clinical development programs, and partnerships, while actively seeking additional funding to support its pipeline.