TuHURA Biosciences, Inc. Enters into $12.5 Million Equity Financing Transaction and Receives Additional $3.0 Million in Warrant Exercise Proceeds to Advance Its Pipeline of Novel Treatments to Overcome Primary Resistance to Cancer Immunotherapy
- Secured total funding of $15.5 million through private placement and warrant exercises
- Strategic milestone-based funding structure ensures capital availability upon achieving key objectives
- Funding supports multiple clinical programs including Phase 3 trial initiation and Phase 2 development
- Company expects to achieve all funding milestones by July 2025, indicating confidence in near-term execution
- 15% discount to market price on private placement indicates dilutive financing terms
- Funding is contingent on achieving specific milestones, creating execution risk
- Additional share issuance and warrants may lead to further dilution
- Company currently under FDA partial clinical hold for planned Phase 3 trial
Insights
TuHURA secures $15.5M funding to advance cancer immunotherapy pipeline with clear milestones for clinical development and merger completion.
TuHURA Biosciences has secured significant financing that strengthens its financial position at a critical stage in its development pipeline. The company has arranged
The structured milestone-based funding approach is particularly noteworthy. Only
The additional
The transaction terms suggest significant dilution for existing shareholders, but with a clear purpose of advancing multiple late-stage assets. For a Phase 3 oncology company, securing this capital without a large pharma partnership indicates both the challenge of current biotech funding markets and management's commitment to maintaining independence through these critical value-creating milestones. The July 2025 timeline for achievement of all funding milestones provides a clear near-term roadmap for investors to track execution.
Secures
Secures an additional
Funding provides capital for:
- Initiation of planned Phase 3 accelerated approval trial of IFx-2.0 targeting
40% enrollment by 2-2025 year end - Acquisition of and initiating a Phase 2 trial in NPM1 mutated AML, a novel VISTA inhibiting antibody through closing of Kineta merger
- Advancing first-in-class immune modulating bi-specific, and bi-functional Antibody Drug Conjugates (ADC) and Antibody Peptide Conjugates (APCs)
Under the definitive agreement, approximately
- One-fourth of the Initial Funding Amount will be purchased and funded after the Company is notified by the Food and Drug Administration (FDA) that the Company is no longer subject to the partial clinical hold set forth in the FDA's Partial Clinical Hold letter dated January 24, 2024, with respect to the Company's planned Phase 3 trial of IFx-2.0;
- One-fourth of the Initial Funding Amount will be purchased and funded after the Company's Phase 3 trial for IFx-Hu2.0 has been initiated; and
- One-fourth of the Initial Funding Amount will be purchased and funded immediately prior to the closing of the Company's proposed merger transaction with Kineta, Inc. (the "Kineta Merger").
The Company currently anticipates that all of the Funding Milestones will be achieved by the end of July 2025.
The warrants issued in the offering will expire on the fifth (5th) anniversary of the initial exercise date, with the initial exercise date being the later of (i) six months from the date of the definitive securities purchase agreement or (ii) the amendment of the Company's articles of incorporation to increase the number of authorized shares of common stock. The exercise price of the warrants is subject to proportional adjustment for stock splits, reverse stock splits, and similar transactions.
The Company currently plans to use the net proceeds from the offering to fund cash requirements for the closing the proposed merger with Kineta, Inc., to fund the initiation of the Phase 3 Trial for IFx-2.0, to fund the advancement of Kineta's KVA12123 novel VISTA-inhibiting antibody to a Phase 2 trial, and for other working capital needs.
Paulson Investment Company, LLC acted as exclusive placement agent for the offering, and Brookline Capital Markets, a division of Arcadia Securities, provided equity market advisory services to the Company.
The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. Accordingly, the shares of the securities may not be offered or sold in
In addition to the offering, the Company secured
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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 is preparing to initiate 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.
Following the proposed merger with Kineta, the Company expects to advance Kineta's novel VISTA inhibiting antibody into a randomized Phase 2 trial in NPM1 Mutated r/r AML in combination with a menin inhibitor.
In addition to its innate immune agonist product candidates, 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.
IMPORTANT ADDITIONAL INFORMATION REGARDING PROPOSED MERGER WITH KINETA
In connection with the proposed acquisition by merger of Kineta, Inc. ("Kineta") by TuHURA (the "Merger"), TuHURA filed with the
A definitive copy of the definitive Joint Proxy Statement/Prospectus was mailed to Kineta and TuHURA stockholders beginning May 23, 2025. Investors and stockholders may obtain free copies of the documents filed or that will be filed with the SEC by TuHURA through the website maintained by the SEC at www.sec.gov. The documents filed by TuHURA with the SEC may also be obtained free of charge at TuHURA's website at www.tuhurabio.com or upon written request to: TuHURA, 10500 University Drive, Suite 110,
NO OFFER OR SOLICITATION
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Merger and is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy the securities of TuHURA or Kineta, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act.
PARTICIPANTS IN THE SOLICITATION
TuHURA and Kineta and their respective directors and officers and other members of management may, under SEC rules, be deemed to be participants in the solicitation of proxies from stockholders in connection with the Merger and other matters that may be set forth in the Joint Proxy Statement/Prospectus. Information about TuHURA's directors and executive officers is set forth in TuHURA's filings with the SEC, including TuHURA's Form 10-K filed on March 31, 2025. Additional information regarding the direct and indirect interests, by security holdings or otherwise, of those persons and other persons who may be deemed participants in the solicitation of proxies in the Merger may be obtained by reading the Joint Proxy Statement/Prospectus. You may obtain free copies of these documents as described above under "IMPORTANT ADDITIONAL INFORMATION REGARDING PROPOSED MERGER WITH KINETA".
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. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding, the satisfaction to the conditions to the completing the offering, the impact of the proceeds from the offering, TuHURA's IFx-Hu2.0 product candidate and anticipated Phase 3 trial, its tumor microenvironment modulators development program, its potential acquisition by merger of Kineta Inc. and the statements about Kineta's VISTA-101 development program and statements regarding the closing conditions for the transaction, TuHURA's needs and expectations regarding its existing capital resources and its need for additional capital (including financing to complete the Kineta merger), and any developments or results in connection therewith and the anticipated regulatory pathway and timing of the foregoing development programs, studies and trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. 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. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.
Investor Contact:
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com
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