TuHURA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides a Corporate Update
Anticipates initiating the Company's Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) agreement with
Initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in first-line Merkel cell carcinoma of unknown primary origin (MCCUP)
Targeting to close the acquisition of
"TuHURA has had an impressive start to 2025, and we continue to execute our corporate strategy as we drive towards TuHURA's four major clinical data readouts anticipated over the next 24 months. We recently initiated our Phase 1b/2a study of IFx-Hu2.0 in combination with pembrolizumab in checkpoint-naïve MCCUP patients. Evaluating IFx-Hu2.0 in MCCUP patients is an important component of our overall strategy for the program, as the Phase 1b/2a trial will include patients without skin lesions who present with metastatic deep-seated tumors in the liver, lungs or retroperitoneum (abdomen), who are not eligible to participate in our Phase 3 accelerated approval trial due to the trial's primary lesion enrollment criteria. Approximately 30% of MCC patients have unknown primary lesions, and demonstrating safety and efficacy in the MCCUP patient population would allow us the opportunity to provide IFx-Hu2.0 to more patients with MCC," said
"In addition to our IFx-Hu2.0 drug candidate, we continue to assemble an exciting late-stage pipeline through our pending acquisition of
Corporate Highlights
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Initiation of Phase 1b/2a Study of IFx-Hu2.0 as Adjunctive Therapy to Keytruda in 1L MCCUP. In
May 2025 , TuHURA announced that it initiated its Phase 1b/2a trial of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in MCCUP. This Phase 1b/2a trial is investigating safety and feasibility of IFx-Hu2.0 when administered via interventional radiology to patients with deep-seated tumors who would not be eligible for the Phase 3 trial.
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Presentation of Two Posters at the
American Association of Cancer Research (AACR) Annual Meeting. InApril 2025 , TuHURA presented a poster at the AACR Annual Meeting outlining a greater than 90% VISTA receptor occupancy following treatment with Kineta's VISTA inhibitor mAb as monotherapy and in combination with pembrolizumab in advanced solid tumors. Additionally, theMarkowitz Lab atMoffitt Cancer Center presented a poster of IFx-Hu2.0, demonstrating increased T Cell and B Cell production in peripheral blood relative to tumor tissue following adjunctive administration of IFx-Hu2.0 in combination with pembrolizumab.
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Appointment of Dr. Bertrand Le Bourdonnec as Head of Drug Discovery. In
April 2025 , TuHURA announced the appointment of Dr. Le Bourdonnec as the Company's Executive Vice President, Head of Drug Discovery,Early Development and Program Management. Dr. Le Bourdonnec has extensive experience in the biology and molecular pharmacology of the DOR, TuHURA's core target on MDSCs for the Company's emerging suite of ADC and APC development candidates.
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Appointment of Dr.
Craig L. Tendler to Board of Directors. InMarch 2025 , TuHURA announced the appointment of industry veteran Dr.Craig Tendler to its Board of Directors.Dr. Tendler brings to TuHURA decades of experience in cancer therapeutic development, and most recently served as Johnson & Johnson's Vice President,Oncology Clinical Development . During his tenure at J&J,Dr. Tendler oversaw 30 major drug approvals, and led development planning from proof of concept through registration and life-cycle management, for J&J's treatments in hematological malignancies and more prevalent solid tumor diseases.
Upcoming Anticipated Milestones by Program
IFx-Hu2.0
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Q2 2025: TuHURA anticipates the
FDA's complete response letter lifting the partial clinical hold relating to completion of certain CMC requirements. - Q2 2025: Initiation of Phase 3 accelerated approval trial in first line Merkel cell carcinoma
VISTA Inhibiting Monoclonal Antibody
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Q2 2025: TuHURA expects to close its acquisition of
Kineta, Inc. and Kineta's VISTA inhibiting mAb. - Q3 2025: Initiation of Phase 2 trial of VISTA inhibiting mAb in combination with a menin inhibitor for the treatment of NPM1-mutated AML.
ADC and APC Development Candidates
- TuHURA continues to advance its bi-specific, bi-functional immune modulating ADCs and APCs that target the DOR on MDSCs, inhibiting their immune suppressing effects in the tumor microenvironment while localizing a checkpoint inhibitor like the VISTA inhibiting antibody.
- In 2025, TuHURA anticipates presenting non-clinical data at relevant medical meetings.
Financial Results for the Three Months Ended
Research and development expenses were
General and administrative expenses were
As of
As previously announced, on
About
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.
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
A definitive copy of the Joint Proxy Statement/Prospectus will be mailed to Kineta and TuHURA stockholders when that document is final. Investors and stockholders will be able to obtain free copies of the documents filed or that will be filed with the
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
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 TuHURA's IFx-Hu2.0 product candidate and anticipated Phase 3 trial, its tumor microenvironment modulators development program, its potential acquisition by merger of
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@GilmartinIR.com
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