SHERIDAN, WYOMING - December 15, 2025 - TuHURA Biosciences, Inc. (NASDAQ:HURA) announced that Kintara's REM-001 clinical trial in ten metastatic cutaneous breast cancer patients met its primary endpoint demonstrating safety, a contractual milestone that is expected to trigger distribution of TuHURA common stock to eligible contingent value right (CVR) holders.
Clinical milestone activates CVR mechanics for legacy Kintara holders
TuHURA said the REM-001 trial achieved the primary safety endpoint with signs of clinical efficacy following eight weeks of follow-up for the enrolled patients. Under the Contingent Value Rights Agreement dated October 18, 2024-between TuHURA and rights agent Equiniti Trust Company, LLC-the company stated that this milestone enables the release of an aggregate of 1,539,958 shares of TuHURA common stock to legacy Kintara Therapeutics stockholders who hold CVRs. TuHURA added that the shares are expected to be distributed to CVR holders within the next ten business days, subject to the terms of the CVR Agreement and any applicable withholding.
What the REM-001 update means operationally
While the disclosure is framed around a contractual milestone, the underlying driver is trial execution and follow-up completion. For biopharma operators and investors, this type of update is often read as a signal that the program cleared a defined gating requirement-reducing near-term uncertainty around whether the company would satisfy conditions tied to post-merger consideration.
Importantly, the company's language points to safety and early clinical signals after eight weeks, but does not provide detailed efficacy endpoints or response metrics in this release. As a result, the near-term takeaway is more about milestone confirmation and governance execution than a full clinical readout.
TuHURA's lead program and Phase 3 registration pathway
TuHURA describes itself as a Phase 3 immuno-oncology company developing technologies intended to overcome primary and acquired resistance to cancer immunotherapy. The company's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.
From a commercial strategy perspective, pairing an adjunctive candidate with an established checkpoint inhibitor can sharpen the value proposition-if it can demonstrate clinically meaningful benefit in populations where response remains inconsistent or durability is limited.
Pipeline breadth: VISTA inhibition and conjugate approaches
Beyond IFx-2.0, TuHURA noted it acquired TBS-2025 in its merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting mAb moving into Phase 2 development in mutNPM1 r/r AML. The company also highlighted its Delta Opioid Receptor technology as the basis for developing first-in-class bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells, with the aim of inhibiting immune-suppressing effects in the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
Why CVR-trigger events matter in biotech M&A and financing
CVR structures are commonly used to bridge valuation gaps when future outcomes-often clinical or regulatory-are uncertain at deal close. For operators, the operational implication is that program execution, timelines, and follow-up completeness can have direct capital-markets consequences, including share issuance schedules and investor communications. In this case, TuHURA is explicitly tying the milestone to a defined distribution expectation, which can help reduce ambiguity for eligible CVR holders.
For more information about TuHURA Biosciences, visit https://www.tuhurabio.com.