8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

    Date of Report (Date of earliest event reported): March 7, 2025

   

TUHURA BIOSCIENCES, INC.

(Exact name of Registrant as Specified in Its Charter)


Nevada	001-37823	99-0360497
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

10500 University Center Dr., Suite 110
Tampa, Florida 33612
(Address of Principal Executive Offices, including zip code)
Registrant’s Telephone Number, Including Area Code: (813) 875-6600

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

    
Title of each class

    Trading
Symbol(s)

Name of each exchange on which registered

    Common Stock, $0.001 par value per share
 
    HURA

    The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

    Item 5.02

    Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On March 7, 2025, the Board of Directors (the “Board”) of TuHURA Biosciences, Inc. (the “Company”) increased the size of the Board from five members to six members and appointed Dr. Craig Tendler to the Board, effective as of March 10, 2025, to serve as a director until the Company’s 2025 Annual Meeting of Stockholders and until his successor has been duly elected and qualified or until his earlier death, resignation or removal. The Board expects to appoint Dr. Tendler to one or more Board committees at a later date.

Dr. Tendler, age 66, is an experienced pharmaceutical and biotech industry professional. From January 2010 through December 2024, Dr. Tendler served as the Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs of Johnson & Johnson Innovative Medicine Research & Development where was responsible for creating and overseeing robust development plans, including optimal integration of biomarkers and diagnostics, and comprehensive data generation activities for all products in the oncology portfolio. During his tenure at Johnson & Johnson, Dr. Tendler and his team worked in collaboration with the Federal Drug Administration (“FDA”) and the European Medicines Agency to secure worldwide approvals of transformational treatment in prostate cancer, hematologic malignancies, as well as for lunch and bladder cancer. He played an instrumental role in achieving 13 FDA breakthrough designations for accelerating the early development of promising investigational medicines intended for the treatment of serious oncology conditions.

Prior to joining Johnson & Johnson Innovative Medicine, Dr. Tendler served as the Vice President of Oncology Clinical Research and Chair of the Oncology Licensing Committee at the Schering-Plough Research Institute. In addition to his pharmaceutical industry experience, Dr. Tendler has served as Co-Chair of the Friends of Cancer Research Corporate Council, member of the Bloomberg New Economy International Cancer Coalition, and member of the Admissions Committee, Mount Sinai School of Medicine. Dr. Tendler was an Assistant Professor of Pediatrics/Hematology-Oncology at the Mount Sinai School of Medicine and a NIH physician-scientist grant recipient and research fellow at the National Cancer Institute in Bethesda, Maryland. Dr. Tendler earned his undergraduate degree from Cornell University and graduated from the Mount Sinai School of Medicine, New York City, with high honors and induction into the Alpha Omega Alpha Medical Society.

In connection with Dr. Tendler’s appointment to the Board, Dr. Tendler was granted on March 10, 2025, an option to purchase 151,883 shares of the Company’s common stock, with an exercise price equal to the closing price of the Company’s common stock on the date of the grant pursuant to the Company’s 2024 Equity Incentive Plan. The Company also intends to enter into an indemnification agreement with Dr. Tendler in the same form as the Company’s standard form indemnification agreement with its other directors, which is attached as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on October 21, 2024.

No arrangement or understanding exists between Dr. Tendler and any other person pursuant to which Dr. Tendler was selected as a director of the Company. Dr. Tendler does not have any family relationships with any of the Company’s directors or executive officers. There are no transactions in which Dr. Tendler had an interest requiring disclosure under Item 404(a) of Regulation S-K.

A copy of the press release announcing Dr. Tendler’s appointment is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 7.01 Regulation FD Disclosure.

On March 10, 2025, the Company issued a press release announcing the appointment of Dr. Tendler to the Board, a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information set forth in this Item 7.01 and Exhibit 99.1 shall not be deemed “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No. Document

99.1 Press Release dated March 10, 2025

104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


			TUHURA BIOSCIENCES, INC.

Date:	March 11, 2025	By:	/s/ Dan Dearborn
			Name: Dan Dearborn Title: Chief Financial Officer

TuHURA Biosciences, Inc Appoints Craig L. Tendler M.D., Former Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs, Johnson & Johnson Innovative Medicine Research & Development, to its Board of Directors

Dr. Tendler oversaw 30 Major Drug Approvals, including worldwide approvals for J&J’s transformational treatments in hematologic malignancies, prostate, lung and bladder cancers

Dr. Tendler also oversaw 13 FDA Breakthrough Designations accelerating the early development of promising investigational medicines intended for treatment of serious oncology indications

TAMPA, FL, March 11, 2025 -- TuHURA Biosciences, Inc. (NASDAQ:HURA) (“TuHURA”), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced it has appointed Craig L. Tendler, M.D. to its Board of Directors effective March 10, 2025.

“We are honored and thrilled to have Craig join our Board of Directors. His extensive experience in creating and overseeing development plans, including integration of biomarkers and diagnostics and overseeing comprehensive data-generation activities for all products in the oncology portfolio while at J&J, from proof of concept through registration and lifecycle management, will be a valuable asset to TuHURA as we advance IFx-2.0 through its registrational Phase 3 clinical trial planned to begin in second quarter 2025 and while we pursue optimal positioning of our pipeline of novel therapeutics focused on overcoming resistance to cancer immunotherapy,” commented James Bianco, M.D., President and Chief Executive Officer of TuHURA. “His experience in overseeing major oncology business development opportunities, culminating in the acquisition/co-development of practice-changing oncology products, will be valuable in assisting the Company in evaluating potential corporate collaborations and potential acquisitions of other novel therapeutics to add to the Company’s pipeline.”

“His impressive track record achieving worldwide approvals for transformational treatments in prostate cancer (ZYTIGA, AKEEGA, and ERLEADA), hematologic malignancies (DARZALEX, CARVYKTI, TECVAYLI, TALVEY, IMBRUVICA), as well as for lung (RYBREVANT) and bladder cancer (BALVERSA), will supplement the Board’s broad expertise with proven results across all aspects of oncology drug development at a critical juncture in TuHURA’s development programs,” noted James Manuso, Ph.D., Chairman of TuHURA’s Board of Directors.

Dr. Tendler added, “TuHURA has established a science-based portfolio of novel complementary technologies and late-stage drug candidates that I believe has the potential to make a significant impact on the immuno-oncology treatment landscape. The data demonstrated to date are promising and underscore the ability of one of their potential therapeutics, IFx-2.0, to overcome resistance to immune checkpoint inhibitor therapy, a much-needed advance to further the

patient benefit of this important class of cancer immuno-therapeutics. With their recent agreement with Kineta to acquire its VISTA inhibiting antibody, leveraging their novel discovery of the critical role the delta opioid receptor may play in controlling the immune suppressing capabilities of myeloid derived suppressor cells (MDSCs) and tumor associated M2 polarized macrophages, I feel this is an optimal time to bring my experience in oncology drug development to the Board and to management. I look forward to contributing to the continued growth and future success of the Company.”

Dr. Tendler previously served as Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs of Johnson & Johnson Innovative Medicine Research & Development (Retired). In this position, he was responsible for creating and overseeing robust development plans, including optimal integration of biomarkers and diagnostics, and comprehensive data generation activities for all products in the oncology portfolio, from proof of concept through registration and lifecycle management. He worked closely with teams in early development and the disease areas of focus to implement a seamless end-to-end oncology clinical research strategy that incorporated compelling science, broad clinical trial access to diverse populations, and addressed areas of high unmet medical need.

During his tenure at Johnson & Johnson, Dr. Tendler and his team worked in collaboration with the FDA and the European Medicines Agency to secure the worldwide approvals of transformational treatments in prostate cancer (ZYTIGA, AKEEGA, and ERLEADA), hematologic malignancies (DARZALEX, CARVYKTI, TECVAYLI, TALVEY, IMBRUVICA), as well as for lung (RYBREVANT) and bladder cancer (BALVERSA). He has played an instrumental role in achieving 13 FDA breakthrough designations for accelerating the early development of promising investigational medicines intended for the treatment of serious oncology conditions.

Prior to joining Johnson & Johnson Innovative Medicine, Craig served as the Vice President of Oncology Clinical Research and Chair of the Oncology Licensing Committee at the Schering-Plough Research Institute. In addition to his pharmaceutical industry experience, Craig has served as Co-Chair of the Friends of Cancer Research Corporate Council, member of the Bloomberg New Economy International Cancer Coalition, and member of the Admissions Committee, Mount Sinai School of Medicine. He was an Assistant Professor of Pediatrics/Hematology-Oncology at the Mount Sinai School of Medicine and a NIH physician-scientist grant recipient and research fellow at the National Cancer Institute in Bethesda, Maryland.

Dr. Tendler earned his undergraduate degree from Cornell University, and graduated from the Mount Sinai School of Medicine, New York City, with high honors and induction into the Alpha Omega Alpha Medical Society.

About TuHURA Biosciences, Inc.

TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 registration-stage 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 drug candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate in the second quarter 2025, a single randomized placebo-controlled Phase 3 registration=directed trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® and placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.

In addition to its innate immune agonist candidates, following the closing of the previously announced proposed merger with Kineta, TuHURA plans to advance its VISTA inhibiting antibody into a phase two trial in combination with a menin inhibitor in NPM1 mutated relapsed or refractory AML. Leveraging its discovery of the central role the Delta Opioid Receptor plays in modulating the immunosuppressive effects of myeloid derived suppressor cells (MDSCs) and tumor associated M2 polarized macrophages on the tumor microenvironment (TME), the Company is also developing non-tumor targeting ADCs and APCs to convert the TME to an immunogenic phenotype, potentially overcoming acquired resistance to checkpoint inhibitors and cellular therapies.

For more information, please visit tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.

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 including, without limitation, statements regarding clinical trials and research and development programs, in particular with respect to TuHURA’s IFx-Hu2.0 product candidate and its ADC and PDC development program, and any developments or results in connection therewith. 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.

You are cautioned that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. 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:

JTC Team, LLC

Jenene Thomas

(908) 824-0775

[email protected]