TuHURA Biosciences Announces its Release of Kintara's Contingent Value Right (CVR) as Kintara's REM-001 Meets Primary Safety Endpoint Achieving Contractual Milestone
TuHURA Biosciences (NASDAQ:HURA) announced that Kintara's REM-001 clinical trial in ten metastatic cutaneous breast cancer patients met its primary safety endpoint with signs of clinical efficacy after eight weeks of follow-up.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
TuHURA Biosciences (NASDAQ:HURA) announced that Kintara's REM-001 clinical trial in ten metastatic cutaneous breast cancer patients met its primary safety endpoint with signs of clinical efficacy after eight weeks of follow-up. Under the Contingent Value Rights Agreement dated October 18, 2024, this milestone triggers the release of an aggregate of 1,539,958 shares of TuHURA common stock to legacy Kintara stockholders. The CVR holders are entitled to receive the shares subject to the CVR terms and applicable withholding. The shares are expected to be distributed to CVR holders within the next ten business days.
Positive
- Primary safety endpoint met in REM-001 trial
- Aggregate 1,539,958 shares set for CVR distribution
- Shares expected to distribute within 10 business days
Negative
- Issuance of 1,539,958 shares may dilute existing shareholders
- Distributions are subject to withholding and CVR terms
Details
News Market Reaction – HURA
On Dec 15, the day this news came out, HURA closed 6.01% below the previous close.
Data tracked by StockTitan Argus for the Dec 15 session.
Key Figures
- Trial patients
- 10 patients
- REM-001 metastatic cutaneous breast cancer clinical trial
- Follow-up duration
- 8 weeks
- Safety and efficacy follow-up for REM-001 trial patients
- CVR share release
- 1,539,958 shares
- TuHURA common stock to legacy Kintara stockholders upon milestone
- CVR agreement date
- October 18, 2024
- Date of Contingent Value Rights Agreement with Kintara holders
- Distribution window
- 10 business days
- Expected timing to distribute TuHURA shares to CVR holders
Historical Context
-
Update on IFx-2.0, VISTA antibody, DOR programs and recent financing.
-
ASH data showing DOR inhibition reduces myeloid immunosuppressive activity.
-
Q3 loss, higher cash burn, going-concern language and ATM filing.
-
DOR research selected for oral talk and posters at ASH 2025.
-
Planned presentation at H.C. Wainwright global investment conference.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
contingent value right financial
primary endpoint medical
clinical efficacy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Milestone Triggers Release of Shares to Kintara Contingent Value Right (CVR) Holders
Pursuant to the terms of the Contingent Value Rights Agreement dated as of October 18, 2024, by and between TuHURA Biosciences, Inc. and the rights agent, Equiniti Trust Company, LLC (the "CVR Agreement"), as a result of the trial and the completion of the follow-up, the milestone required for the release of an aggregate of 1,539,958 shares of TuHURA common stock to legacy Kintara Therapeutics stockholders has been achieved. The holders of CVRs are entitled to receive shares of TuHURA common stock, subject to the terms of the CVR Agreement and any applicable withholding. Pursuant to the CVR Agreement, the shares of TuHURA common stock are expected to be distributed to the CVR holders within the next ten business days.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.
TuHURA'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 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.
In addition to its innate immune agonist product candidates, TuHURA 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. In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at www.sec.gov.
The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
Investor Contact:
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-announces-its-release-of-kintaras-contingent-value-right-cvr-as-kintaras-rem-001-meets-primary-safety-endpoint-achieving-contractual-milestone-302641610.html
SOURCE TuHURA Biosciences, Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.