Entry into a Material Definitive Agreement

On May 5, 2025, TuHURA Biosciences, Inc. ("TuHURA" or the "Company") and Kineta, Inc., a Delaware corporation ("Kineta"), entered into a First Amendment (the "Amendment") to the previously disclosed Agreement and Plan of Merger, dated December 11, 2024 (as amended from time to time, the "Merger Agreement"), by and among TuHURA, Kineta, Hura Merger Sub I, Inc., a Delaware corporation and a direct wholly-owned subsidiary of TuHURA ("Merger Sub I"), Hura Merger Sub II, LLC, a Delaware limited liability company and direct wholly-owned subsidiary of TuHURA ("Merger Sub II," and together with Merger Sub I, the "Merger Subs"), and Craig Philips, solely in his capacity as the representative, agent and attorney-in-fact of the stockholders of Kineta (the "Stockholders Representative") (Filing, TuHURA Biosciences, MAY 5, 2025, View Source [SID1234652653]). Each capitalized term used but not otherwise defined under Item 1.01 of this Current Report on Form 8-K has the meaning given to it in the Merger Agreement.

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As previously disclosed, pursuant to the terms of the Merger Agreement and subject to the terms and conditions set forth therein, Merger Sub I will (a) merge with and into Kineta (the "First Merger"), with Kineta being the surviving corporation of the First Merger, also known as the "Surviving Entity"; and (b) immediately following the First Merger and as part of the same overall transaction as the First Merger, the Surviving Entity will merge with and into Merger Sub II (the "Second Merger" and, together with the First Merger, the "Mergers" ), with Merger Sub II being the surviving company of the Second Merger.

Also, as previously disclosed, subject to the terms and conditions of the Merger Agreement, at the effective time of the First Merger (the "Effective Time"), each share (the "Share") of Kineta’s common stock, par value $0.001 per share ("Kineta Common Stock"), issued and outstanding immediately prior to the Effective Time (other than (i) Shares held in treasury by Kineta or held directly by TuHURA or the Merger Subs, which Shares will be cancelled, or (ii) Shares that are held by any holder who is entitled to demand and properly demands appraisal of such Shares of pursuant to, and in compliance with, Section 262 of the General Corporation Law of the State of Delaware) will thereupon be converted automatically into and will thereafter represent the right to receive, without interest, (x) the number of validly issued, fully paid and non-assessable shares of common stock, $0.001 par value per share, of TuHURA ("TuHURA Common Stock") (rounded down to the nearest whole share subject to the payment of any cash in lieu of fractional shares as set forth in the Merger Agreement) equal to (i) the Initial Per Share Stock Consideration plus (ii) the Delayed Per Share Stock Consideration, (y) plus an amount in cash equal to (i) the Per Share Cash Consideration plus (ii) the Disposed Asset Payment Right (collectively, the Initial Per Share Stock Consideration, the Delayed Per Share Stock Consideration, the Per Share Cash Consideration and the Disposed Asset Payment Right are referred to as the "Merger Consideration").

Among other things, the following terms in the Merger Agreement have been revised pursuant to the Amendment as follows:

As amended, "Initial Per Share Stock Consideration" means the number of shares of TuHURA Common Stock being issued for each share of Kineta Common Stock, determined as follows:


the difference of $16,500,000 and any deductions if the Per Share Cash Consideration (as described below) is less than zero;

such difference in the first bullet, divided by $5.7528, such stock price, the "Parent Share Value"; and

with such resulting quotient from the second bullet, divided by the fully diluted Kineta Common Stock, all rounded down to six (6) decimal places.
As amended, "Delayed Per Share Stock Consideration" means the number of shares of TuHURA Common Stock being issued for each share of Kineta Common Stock, determined as follows:


the difference of $6,500,000 and (i) any liabilities incurred by TuHURA due to a breach of the undisclosed liabilities representation made by Kineta in the Merger Agreement; (ii) any and all losses incurred through the six months after the Closing and those losses estimated to be incurred by TuHURA related to any stockholder litigation; and (iii) any amount to which the closing net working capital deficient is greater than $6,000,000;

such difference in the first bullet, divided by the Parent Share Value; and

with such resulting quotient from the second bullet, divided by the fully diluted Kineta Common Stock, all rounded down to six (6) decimal places.
As amended, "Per Share Cash Consideration" means an amount in cash for each share of Kineta Common Stock, determined as follows:


the difference of $12,000,000 and (i) $5,000,000 (as credit for the exclusivity payment already made by TuHURA to Kineta); (ii) $300,000 (as credit for the extension payment already made by TuHURA to Kineta); (iii) $695,000 (which represents advances already made by TuHURA to Kineta in connection with the exclusivity agreement); (iv) the Loaned Amount, if any; and (v) if the net working capital is less than $0, such difference (and if the net working capital is greater than $0, then such difference will be added to the $12,000,000 base cash consideration); and

such difference in the first bullet, divided by the fully diluted Kineta Common Stock, all rounded down to six (6) decimal places.
As amended, "Loaned Amount" means all principal and interest outstanding under any loan between TuHURA, on the one hand, and Kineta, on the other hand, consisting of (i) $250,000 that was previously advanced by TuHURA to Kineta, (ii) $250,000 to be advanced by TuHURA to Kineta on or before May 15, 2025, and (iii) $250,000 to be advanced by TuHURA to Kineta on or before June 3, 2025 (with the advance in foregoing clause (iii) being contingent upon TuHURA’s receipt of (A) proceeds from the Concurrent Investment or (B) proceeds from TuHURA stockholder warrant exercise payments due on May 30, 2025), in each case, for any expenses incurred by Kineta in the ordinary course of business or expenses incurred in connection with the Program Assets and approved by TuHURA, and such amount shall be paid by TuHURA to Kineta no later than five (5) Business Days after the request is made (and invoice or proof of expense is provided to TuHURA) as long as no event of default has occurred and is continuing under the Merger Agreement as of the date of such request and so long as the parties thereto are then still working in good faith toward a Closing.

In addition to the foregoing, pursuant to the Amendment, the parties have agreed that, as a condition precedent to the obligations of TuHURA and the Merger Subs to effect the Mergers and otherwise consummate the transaction contemplated by the Merger Agreement, the Concurrent Investment shall have been completed and TuHURA shall have received gross proceeds of no less than Twenty Million Dollars ($20,000,000), which gross proceeds shall have been received by TuHURA, or will be received by TuHURA substantially simultaneously with Closing.

Also pursuant to the Amendment, the End Date has been extended from April 30, 2025, to June 30, 2025, subject to possible extension as provided by the Amendment.

Other than as expressly modified by the Amendment, the Merger Agreement, which was filed as Exhibit 2.1 to the Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission (the "SEC") on December 12, 2024, remains in full force and effect. The foregoing description of the Amendment does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Amendment, which is attached as Exhibit 2.1 hereto and incorporated herein by reference.

Additional Information about the Proposed Mergers and Where to Find It

This communication may be deemed to be solicitation material with respect to the proposed Mergers between TuHURA and Kineta. In connection with the proposed Mergers, TuHURA has filed relevant materials with the SEC, including the preliminary joint proxy statement/prospectus filed on February 7, 2025 and subsequently amended on May 6, 2025 (the "Joint Proxy Statement/Prospectus"). TuHURA will mail a definitive Joint Proxy Statement/Prospectus to the TuHURA stockholders when it becomes available. Investors and securityholders of TuHURA and Kineta are urged to read these materials because they contain important information about TuHURA, Kineta and the Mergers. This communication is not a substitute for the definitive Joint Proxy Statement/Prospectus, when it becomes available, or any other documents that TuHURA may file with the SEC or send to securityholders in connection with the proposed transactions.

Investors and securityholders may obtain free copies of the documents filed with the SEC, once available, on TuHURA’s website at www.tuhurabio.com, on the SEC’s website at www.sec.gov or upon written request to: TuHURA, 10500 University Drive, Suite 110, Tampa, FL 33612.

No Offer or Solicitation

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the "Securities Act").

Participants in the Solicitation

Each of TuHURA, Kineta and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of TuHURA in connection with the proposed Mergers. 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 Mergers may be obtained by reading the definitive Joint Proxy Statement/Prospectus when it becomes available. You may obtain free copies of these documents as described above under "Additional Information about the Proposed Mergers and Where to Find It".

Janux Therapeutics Initiates Phase 1b Expansion Studies with JANX007 in Patients with Prostate Cancer and Provides Program Updates

On May 5, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported the initiation of Phase 1b expansion studies in the ongoing ENGAGER-PSMA-01 trial (Press release, Janux Therapeutics, MAY 5, 2025, View Source [SID1234652532]).

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ENGAGER-PSMA-01 is a first-in-human, open-label, multicenter Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 administered as monotherapy or in combination in adult patients with advanced metastatic castration-resistant prostate cancer (mCRPC).

In December 2024, Janux reported positive interim clinical data from the Phase 1a dose escalation portion of the trial in 16 mCRPC patients with a median of four prior lines of therapy. At that time, the median radiographic progression-free survival (rPFS) reported was 7.4 months for all 16 patients.* As of April 21, 2025, updated results** have been achieved in the same 16 patients supporting the initiation of the Phase 1b expansion studies:

Median rPFS of 7.5 months (n=16)
Median rPFS of 7.9 months for patients treated at 6mg and 9mg target doses (n=9)
6-month rPFS of 65% (n=16)
6-month rPFS of 78% for patients treated at 6mg and 9mg target doses (n=9)
Safety data remained consistent with the December 2024 data disclosure (n=16)
*8/16 patients were noted as in-progress in the December 2024 reported results.
**rPFS results based upon Kaplan-Meier estimate.

In addition, Janux has selected a CRS-mitigation strategy to support the initiation of the Phase 1b expansion studies that is designed to maintain the CRS profile reported in December.

The first Phase 1b expansion study will enroll taxane-naïve mCRPC patients and is designed to generate additional safety and efficacy data in this first and second line (1L/2L) patient population. This study will assess JANX007 monotherapy at two dose regimens (0.3/2/6mg and 0.3/2/9mg) with dosing administered once weekly or once every two weeks in mCRPC patients who have progressed on or after novel hormonal therapy (NHT).

"Initiation of the taxane-naïve study marks an important step as we begin to evaluate JANX007 in earlier-line mCRPC patient populations," said Zachariah McIver, D.O., Ph.D., Chief Medical Officer of Janux. "While therapeutic options for mCRPC have expanded, there remains a significant need for novel, non-chemotherapeutic approaches."

Janux plans to initiate three additional Phase 1b expansion studies, evaluating:

JANX007 in combination with an androgen receptor inhibitor in taxane-experienced mCRPC patients
JANX007 monotherapy in PARP inhibitor-resistant mCRPC patients
JANX007 monotherapy in NHT- and taxane-experienced mCRPC patients designed to support OPTIMUS dose selection for registrational studies
"Improved efficacy and durability of responses has been observed by other prostate cancer drugs and TCEs when moving into earlier lines of therapy. There are also indications that safety with TCEs improve in earlier lines of therapy where disease burden is lower. We believe that these observations, coupled with the data seen in our Phase 1a dose escalation in later line patients, strongly support our decision to develop JANX007 in earlier lines of therapy," said David Campbell, Ph.D., President and CEO of Janux.

Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025. Separately, Janux will host an R&D Day in mid-2025 highlighting product candidates identified from its preclinical pipeline to move into clinical trials.

Largest Sarcoma Study to Date with ctDNA Analysis Demonstrates Excellent Performance for Signatera

On May 5, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the results of a study led by Stanford University School of Medicine for the evaluation of Signatera, Natera’s personalized molecular residual disease (MRD) test, in patients with soft tissue and bone sarcomas (Press release, Natera, MAY 5, 2025, View Source [SID1234652531]). Results of the study (Utilizing Circulating Tumor DNA to Monitor Sarcoma Treatment and Recurrence) were presented at the 2025 Society of Surgical Oncology (SSO) Annual Meeting in March.

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With evaluation of approximately 200 patients and more than 2,100 plasma samples across multiple distinct subtypes, this is the largest sarcoma cohort to date using personalized circulating-tumor DNA (ctDNA) monitoring. The study assessed the correlation of Signatera results with imaging, stratified by sarcoma subtype, and followed patients through treatment, disease progression, and surveillance.

Key findings included:

The results demonstrated excellent test performance, with overall sensitivity to recurrence of 89% and specificity of 100%.
In leiomyosarcoma, the most common subtype in the cohort, sensitivity was 93%, with specificity of 100%.
For leiomyosarcoma patients who experienced progression, ctDNA kinetics during subsequent therapy were highly correlated with treatment response (90%).
Sarcomas are a heterogeneous group of rare cancers, with more than 70 distinct histologic subtypes1, making treatment response and recurrence especially difficult to monitor through standard imaging and clinical evaluation. There are approximately 17,000 new cases of sarcoma diagnosed annually in the United States.2

"This data represents a major step forward in understanding how ctDNA monitoring can be applied across a diverse range of sarcoma subtypes," said Beatrice J. Sun, M.D., department of surgery at Stanford University. "With the ability to noninvasively detect disease recurrence and monitor treatment response, Signatera demonstrates the potential to meaningfully improve personalized care for patients with sarcoma."

"This is the most comprehensive dataset to date on ctDNA monitoring in sarcoma, and it shows excellent performance of Signatera in a difficult-to-monitor cancer," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "The heterogeneity of sarcoma demands a personalized approach, and these results support Signatera’s unique ability to track disease status with precision across a broad spectrum of subtypes."

This retrospective real-world study demonstrates the promise of Signatera as a tool to monitor disease recurrence and treatment response. To build on these findings, the team intends to launch a prospective study to further demonstrate Signatera’s clinical utility and explore its role in informing treatment decisions and improving future sarcoma care.

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

Lantern Advances Drug Candidate LP-184 with IND Clearance for Phase 1b/2 Clinical Trial in Triple Negative Breast Cancer (TNBC)

On May 5, 2025 Lantern Pharma Inc. (Nasdaq: LTRN), an artificial intelligence company developing targeted and transformative cancer therapies using its proprietary AI platform, RADR, reported that it has received clearance of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial for LP-184 in Triple Negative Breast Cancer (Press release, Lantern Pharma, MAY 5, 2025, View Source [SID1234652530]). This achievement builds on the previous regulatory momentum including Orphan Drug Designation in 2023 and Fast Track Designation in 2024.

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Strategic Trial Design to Address Critical Treatment Gap in TNBC

The innovative dual-approach in the clinical trial is designed to evaluate LP-184 in recurrent, advanced-stage TNBC patients through:

Monotherapy Arm: An open-label study involving approximately 30 patients with advanced-stage TNBC, focusing on dose optimization to evaluate, enhance and optimize safety and potential efficacy for TNBC patients.
Combination Therapy: Evaluation of LP-184 in combination with olaparib in second-line settings for patients with advanced-stage TNBC harboring BRCA1 or BRCA2 alterations, with primary endpoints including safety and efficacy parameters that could potentially support a pathway to regulatory approval.
This strategic approach focuses on addressing a significant unmet medical need, with average survival for newly diagnosed metastatic TNBC estimated at 10 to 18 months, representing an annual market opportunity exceeding $4 billion USD.

LP-184 Background in TNBC & Mechanistic Rationale

LP-184 is a synthetically lethal small molecule that induces DNA double strand breaks upon bioactivation by the enzyme prostaglandin reductase 1 (PTGR1) in cancer cells. Preclinical studies and artificial intelligence-driven in silico modeling suggest that cancers with DDR gene alterations may preferentially respond to LP-184.2

Preclinical findings also suggest that LP-184 is particularly well positioned for TNBC with striking data from in vivo models including complete regression seen in several PARP resistant as well as PARP sensitive PDXs (see Figure 1).

Nearly 70% of TNBCs are noted to harbor deficiency in homologous recombination pathways, making them likely to be particularly sensitive tumors for targeting with drug-candidate LP-184. In addition, it is estimated that up to 46% percent of women with TNBC will develop brain metastasis3, and LP-184 has shown blood brain barrier (BBB) penetration, with evidence of activity in preclinical brain metastasis models.

LP-184 Phase 1b/2 TNBC Trial Overview – Monotherapy

The monotherapy phase 1b/2 trial is designed to evaluate LP-184 in patients with advanced-stage TNBC. The study is designed to focus on dose optimization to evaluate and enhance both safety and potential efficacy ultimately aiding in the potential determination of the best clinical position for LP-184 in advanced-stage TNBC patients. The design of the dose optimization phase, provides for evaluation of the safety, efficacy and pharmacokinetics of LP-184 using 2 dose levels in an open-label monotherapy study involving around 30 patients to be dosed with LP-184.

LP-184 Phase 1b/2 TNBC Trial Overview – Combination Therapy with PARP inhibitor

LP-184 has also been shown in preclinical studies to be highly potent in combination with the PARP inhibitor, olaparib, including in tumors that are resistant to PARP inhibitors. In preclinical studies, treatment of a HBCx-28 TNBC PDX model, with BRCA-1 LOH and an HRD score of 63 that was resistant to the PARP inhibitor, showed evidence of re-sensitization in combination with LP-184 (See Figure 2). These data, which were initially presented at the San Antonio Breast Cancer Symposium, support the clinical evaluation of LP-184 in combination with PARPi in an earlier line of treatment. Treating patients in an earlier clinical setting has the potential to reach more patients and potentially generate a more durable and deeper earlier control of the disease.

The design of the combination phase 1b/2 trial provides for LP-184 to be evaluated in a second-line setting in patients with advanced-stage TNBC whose primary tumor harbors alterations in BRCA1 or BRCA2. The primary end points of the study are expected to include safety and efficacy, with the aim of supporting a potential pathway to a regulatory approval process.

Multi-Region Clinical Strategy with Focus on High-Incidence Countries

The trials are planned to be conducted at select centers in the United States as well as academic cancer centers and institutions in India and Nigeria, where TNBC incidence rates are particularly high—comprising nearly 40% of initial breast cancer diagnoses. This strategic site selection is focused on leveraging established collaborative research networks that have a track record of successful collaborative cancer studies with US and European pharma companies. Lantern’s planned objective will be to ensure proper local experience and support for this clinical trial while addressing regions with significant disease burden and high clinical demand.

"This IND clearance for LP-184 in a Phase 1b/2 study represents a pivotal advancement in our mission to bring precisely targeted, AI-developed medicines to patients with aggressive cancers and limited treatment options," said Panna Sharma, CEO and President of Lantern Pharma. "The strategic design of our clinical program reflects both the compelling mechanistic rationale and the encouraging data supporting LP-184’s potential in TNBC."

Expanding Therapeutic Potential Across Multiple Indications

Beyond TNBC, LP-184 shows promise for the potential treatment of other cancers harboring DNA damage repair mutations, including lung, bladder, pancreatic, and ovarian cancers. Additional clinical trials in these targeted indications are in planning stages, with several being considered as Investigator Initiated Trials. LP-184 has received multiple Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the FDA across various solid tumor indications.

The global TNBC market is estimated at $3-5 billion USD annually, with over 300,000 new cases diagnosed worldwide each year. While homologous recombination deficient TNBCs are often initially treated with PARP inhibitors, resistance inevitably develops, underscoring the critical need for novel therapeutic approaches.

AGC Biologics Partners with Novelty Nobility for Cell Line Development and Phase I Preparations of Antibody Drug Candidate

On May 5, 2025 AGC Biologics, your friendly CDMO expert, reported a multiphase partnership with Novelty Nobility Inc., a clinical-stage biotech company based in South Korea (Press release, Novelty Nobility, MAY 5, 2025, View Source [SID1234652529]). Novelty Nobility will leverage AGC Biologics’ expertise and proprietary CHEF1 expression technology for cell line development and prepare for Phase I clinical trials via a multi-site partnership with AGC Biologics’ Copenhagen, Denmark and Chiba, Japan facilities.

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Novelty Nobility develops innovative antibody drugs, including bispecific antibodies and antibody-drug conjugates (ADCs). The company is currently developing two clinical assets in the United States in immunology and oncology, respectively.

AGC Biologics will develop the cell line and create a master cell bank (MCB) for Novelty Nobility’s first-in-class bispecific antibody drug candidate at its Copenhagen facility. After the MCB is created, the second phase of the partnership will focus on expanded process development work and GMP manufacturing preparation at the AGC Biologics Chiba site. The first stage of the project began in March.

"We are very happy with the partnership with Novelty Nobility, where we will apply our CHEF1 platform to a novel bispecific antibody, helping support the advancement of this important candidate towards clinical trials," said Kasper Møller, Chief Technical Officer and Executive Vice President, AGC Biologics. "Our cell line development expertise in Copenhagen is strategically aligned with Novelty Nobility’s objectives, and we believe we can provide a strong foundation for their therapeutic development program."

"Chiba’s partnership with our Copenhagen team gives Novelty Nobility access to world-class cell line development experts while keeping their regional connection strong," noted Susumu Zen-in, Senior Vice President and General Manager, AGC Biologics Chiba. "When clients work with us, they tap into our entire global network – we find the right expertise wherever it exists and bring teams together for a seamless experience, no matter where the work is being done. This approach is already helping us throughout the APAC region and creating wins for both Novelty Nobility and AGC Biologics."

AGC Biologics’ CHEF1 expression technology is a proven platform for cell line development, with a track record of producing stable cell lines for a variety of biologics. With five commercial products on the market and 54 distinct molecules developed, the platform delivers a reliable and efficient path to success. The cell line platform excels in handling complex molecules, providing solutions for challenging biologics that require specialized expression systems. The CHEF1 platform is also royalty-free, eliminating additional costs for clients as their products advance through clinical phases toward commercialization.

AGC Biologics offers a comprehensive suite of services for mammalian-based drug production, from cell line development to commercial manufacturing, enabling partners to accelerate their drug development timelines and bring life-changing therapies to patients. Visit www.agcbio.com/capabilities/mammalian to learn more.