Cypherpunk's Leap Therapeutics subsidiary aligns with FDA on Phase 3 trial for sirexatamab
Leap says the FDA backed a dual-endpoint Phase 3 design in DKK1-high colorectal cancer as parent Cypherpunk reports a $46 million unrealized gain on its Zcash treasury.
Cypherpunk Technologies Inc. (Nasdaq: CYPH) reported second-quarter 2026 results on August 12, 2026, disclosing that its biotechnology subsidiary Leap Therapeutics, Inc. announced the publication of results from the randomized Phase 2 DeFianCe study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in Clinical Cancer Research.1 The company said the peer-reviewed analyses establish that, while the prespecified primary endpoint was not met in the intent-to-treat population, the benefit of sirexatamab increases as a patient's baseline plasma DKK1 level rises, a relationship confirmed by independent statistical approaches, and that together these findings define DKK1-high metastatic colorectal cancer as a biologically distinct population with high unmet need.1
On the regulatory front, Leap Therapeutics held a Type C meeting with the FDA to discuss the DeFianCe results and proposed registrational path for sirexatamab in DKK1-high, second-line mCRC, and the FDA provided feedback supporting key elements of the proposed Phase 3 design, including a DKK1 biomarker-selected population and a dual-endpoint structure meant to support both accelerated and full approval.1 The planned trial would compare sirexatamab plus investigator's-choice chemotherapy (FOLFIRI or mFOLFOX6) and bevacizumab against chemotherapy and bevacizumab alone, enrolling about 270 DKK1-high mCRC patients randomized 1:1, with accelerated approval potentially based on objective response rate in an initial 160 patients and overall survival assessed in the full population for full approval and global registration.1 A companion diagnostic is also planned, as a blood-based companion diagnostic would be developed in parallel to identify DKK1-high patients in routine clinical practice.1
Separately, in May 2026 the FDA granted Fast Track designation to sirexatamab in combination with fluoropyrimidine plus oxaliplatin- or irinotecan-based chemotherapy and bevacizumab for DKK1-high mCRC patients who progressed after one prior therapy.1 Leap said it has initiated a strategic process to identify the best path forward for sirexatamab and secure resources for Phase 3, considering options including independent financing or a strategic transaction such as a partnership, license, collaboration, or sale.1
On finances, Cypherpunk reported net income of $39.4 million, or $0.18 per diluted share, versus a net loss of $16.6 million a year earlier, driven primarily by a $46.0 million unrealized gain on the fair value of its ZEC treasury holdings.1 Cash and cash equivalents totaled $7.6 million as of June 30, 2026, with ZEC treasury holdings valued at $129.4 million.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.