TuHURA Biosciences Announces its Release of Kintara's Contingent Value Right (CVR) as Kintara's REM-001 Meets Primary Safety Endpoint Achieving Contractual Milestone

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

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

Market Reality Check

$1.02 Last Close

Volume Volume 563,066 is 1.25x the 20-day average of 450,152 ahead of this CVR milestone news. normal

Technical Shares last traded at $1.03, well below the 200-day MA of $2.76 and 83.22% under the 52-week high of $6.11.

Peers on Argus

Biotech peers showed mixed moves: IO Biotech -6.09%, Pyxis Oncology -2.27%, Avalo -2.11%, Skye Bioscience -5.22%, while Oncolytics Biotech gained 2.25%, suggesting stock-specific rather than broad sector momentum around this HURA CVR milestone.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 11	Corporate update	Positive	+0.5%	Update on IFx-2.0, VISTA antibody, DOR programs and recent financing.
Dec 08	Clinical data	Positive	+2.1%	ASH data showing DOR inhibition reduces myeloid immunosuppressive activity.
Nov 14	Earnings & update	Negative	+0.5%	Q3 loss, higher cash burn, going-concern language and ATM filing.
Nov 03	Conference selection	Positive	-0.4%	DOR research selected for oral talk and posters at ASH 2025.
Aug 20	Investor conference	Neutral	-0.7%	Planned presentation at H.C. Wainwright global investment conference.

Pattern Detected

Recent news catalysts have produced relatively modest price reactions, with 3 aligned and 2 divergent moves, suggesting no consistent pattern of strong trading responses to updates.

Recent Company History

Over the last few months, TuHURA reported Q3 2025 financials with higher R&D spend and liquidity concerns on Nov 14, presented Delta Opioid Receptor data at ASH in early December, and provided a financing-backed corporate update on Dec 11. Earlier, it highlighted DOR research selection for ASH on Nov 3 and an investor conference appearance on Aug 20. Today’s CVR-related share release ties back to the Kintara transaction and ongoing clinical progress milestones.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-03

$250,000,000 registered capacity

An effective mixed Form S-3 shelf filed on Nov 3, 2025 registers up to $250,000,000 of securities and supports an ATM component of up to $50,000,000, providing flexibility for future financings and resales by existing holders under the base shelf.

Market Pulse Summary

This announcement confirms that REM-001 met its primary safety endpoint in 10 metastatic cutaneous breast cancer patients after 8 weeks, triggering release of 1,539,958 TuHURA shares to Kintara CVR holders. Investors may track subsequent REM-001 efficacy updates, overall share count trends, and funding tools such as the $250,000,000 S-3 shelf and ATM program alongside previously disclosed liquidity considerations from recent SEC filings.

Key Terms

contingent value right financial

"Milestone Triggers Release of Shares to Kintara Contingent Value Right (CVR) Holders"

A contingent value right is a special security that gives its holder the right to receive one or more future payments only if specified events happen, such as a product reaching a sales target or getting regulatory approval. It matters to investors because it offers potential extra payout tied to uncertain outcomes—like a bet that a project will succeed—so it can add upside to a deal while also carrying extra risk and valuation uncertainty.

primary endpoint medical

"met its primary endpoint demonstrating safety with signs of clinical efficacy"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

AI-generated analysis. Not financial advice.

Milestone Triggers Release of Shares to Kintara Contingent Value Right (CVR) Holders

TAMPA, Fla., Dec. 15, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that Kintara's REM-001 clinical trial of ten metastatic cutaneous breast cancer patients met its primary endpoint demonstrating safety with signs of clinical efficacy following eight weeks of follow-up for such patients. 

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

What did TuHURA (HURA) announce on December 15, 2025 about Kintara's REM-001 trial?

TuHURA said Kintara's REM-001 met its primary safety endpoint with signs of clinical efficacy after eight weeks, triggering a CVR milestone.

How many TuHURA (HURA) shares will be released to CVR holders and when?

An aggregate of 1,539,958 shares will be released and are expected to be distributed within 10 business days.

What does the CVR milestone mean for TuHURA shareholders (HURA)?

The milestone triggers issuance of 1,539,958 shares to CVR holders, which may cause dilution to existing shareholders.

Are CVR distributions to HURA holders conditional or final?

Distributions are subject to the CVR Agreement and any applicable withholding, per the announcement.

What clinical result triggered the HURA CVR share release for Kintara?

The release was triggered because REM-001 met its primary safety endpoint with signs of clinical efficacy after eight weeks of follow-up.