On May 5, 2025 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of small molecules and their formulations, able to be activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of various cancers, bacteria and viruses, reported that its latest interim clinical data was recently presented at the Canadian Bladder Cancer Forum 2025 and the American Urological Association 2025 Annual Meeting (Press release, Theralase, MAY 5, 2025, View Source [SID1234653900]).

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The interim clinical data from Theralase’s multicenter Phase II Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") study ("Study II") was presented by Dr. Girish Kulkarni in podium presentations. Dr. Kulkarni, M.D., Ph.D., FRCSC is a urologic surgeon in the Department of Surgical Oncology, Princess Margaret Cancer Centre, University Health Network, a professor in the Department of Surgery at the University of Toronto and the lead principal investigator in the Theralase study.

The interim clinical data presented represents world-class safety and efficacy in the treatment of BCG-Unresponsive NMIBC CIS with a light-activated small molecule. Numerous patients have demonstrated durations of response of 3 years or greater, with 1 patient demonstrating a duration of response of over 7 years, after a single treatment.

Study II Interim Clinical Data1:
Theralase has enrolled and treated 79 patients in Study II, who have been provided the primary Study Procedure (therapeutic dose of Theralase’s lead small molecule RuvidarTM light-activated by the TLC-3200 medical laser system), with completion of enrollment expected by mid-2025.

81% (64/79) of treated patients have completed the clinical study or have been prematurely removed by the PI according to the clinical study protocol are used in the efficacy analysis below.

Performance to Primary Objective:
For the primary endpoint, 62.5% (40/64) of patients treated demonstrated a Complete Response ("CR") (negative cystoscopy and negative urine cytology) at any point in time).

Including patients, who demonstrated an Indeterminate Response ("IR") (negative cystoscopy and positive or suspicious urine cytology), the Total Response increases to 68.8% (44/64).

Primary Endpoint Performance (CR at any Point in Time)
# % Confidence Interval (95%)
Complete Response ("CR") 40 62.5% [43.1, 81.9]
Total Response (CR and IR) 44 68.8% [48.5, 89.1]
Performance to Secondary Objective:
For the secondary endpoint, 45.0% (18/40) of patients, who achieved a CR, maintained their CR response for at least 12 months (450 days from date of Study Procedure).

Secondary Endpoint Performance (Duration of CR) (450 Days)
# % Confidence Interval (95%)
Complete Response ("CR") 18 45.0% [24.2, 65.8]
Performance to Tertiary Objective:
For the tertiary endpoint, 100% (64/64) of patients experienced no Serious Adverse Events ("SAEs") directly related to the Study Drug or Study Device.

Tertiary Endpoint Performance (Safety) (450 Days)
# %
Safety 64 100.0%
25.0% (10/40) of patients who achieved a CR, continue to demonstrate a CR at 24 months from the date of the Study Procedure.

20.0% (8/40) of patients who achieved a CR continue to demonstrate a CR at 36 months from the date of the Study Procedure.

33% (1/3) of patients enrolled in the Phase Ib NMIBC clinical study2 treated once with the Study Procedure has demonstrated a sustained CR lasting over 7 years.

Serious Adverse Events

For 79 patients treated in Study II, there have been 15 Serious Adverse Events ("SAEs") reported:

1 – Grade 1 (resolved within 9 days)
3 – Grade 2 (resolved within 1, 1 and 33 days, respectively)
7 – Grade 3 (resolved within 1, 2, 3, 4, 4, 82 and unknown days, respectively)
3 – Grade 4 (resolved within 3, 6 and 8 days, respectively)
1 – Grade 5
Theralase believes all SAEs reported to date are unrelated to the Study II Drug or Study II Device.

Pending regulatory approval, this innovative technology represents a significant opportunity for an advancement in bladder cancer treatment, with only one treatment, by providing a safe and effective therapy for patients, who have exhausted their standard of care therapeutic options and are facing radical cystectomy (bladder removal).

Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase stated, "I am delighted that the interim clinical data of Study II continues to demonstrate both high safety and high efficacy in the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS. Management of BCG-Unresponsive NMIBC CIS is and remains an unmet need and I look forward to the completion of enrollment in the clinical study this summer, which pending regulatory approval could provide an opportunity for patients to receive this treatment as part of routine clinical practice in both Canada and the United States. What we have learned in our research is that Theralase’s light-activated small molecule, Ruvidar, is able to destroy cancer through the production of reactive oxygen species and stimulation of the immune system by blocking multiple immune checkpoints, such as: CD474 (a dominant macrophage checkpoint signal on cancer cells that signals the immune system whether to destroy them or leave them alone), PD-L15 (a protein that acts as a "brake" on the immune system, preventing T cells from attacking cancer cells) and the recently discovered reduction of deubiquitinating enzymes6 (an important class of enzymes, which have been linked to numerous cancers and neurogenerative diseases)."

Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer, Theralase stated, "The presentation of the interim clinical data to the urological community at the major Canadian and American conferences provides the global urologist community and healthcare professionals, an opportunity to see firsthand the strong clinical data that the uro-oncologists involved in the clinical study have been able to deliver with the Theralase technology. RuvidarTM has proven to be a very versatile small molecule, with its ability to destroy cancer, bacteria and viruses, when activated by light, radiation, sound or even other drugs. Pending regulatory approval, the latest clinical data presented supports the use of light-activated Ruvidar by the urology community to safely and effectively treat patients inflicted with BCG-Unresponsive NMIBC CIS, helping to revolutionize the treatment landscape for bladder cancer. As Theralase wraps up the Phase II NMIBC clinical study in 2025 with a Health Canada and FDA regulatory submission planned in late 2026, I look forward to working with our world-class scientists, researchers and medical doctors in the commencement of numerous new clinical studies, focused on hard to treat viral infections, such as herpes simplex virus lesions (cold sores), through to some of the deadliest and most difficult to treat cancers in the world, such as: glioblastoma multiforme, non-small cell lung cancer, pancreatic cancer, leukemia, muscle invasive bladder cancer and colorectal cancer."

About Carcinoma In-Situ:
CIS of the bladder is an aggressive type of NMIBC characterized as a flat, high-grade tumour confined to the urothelial layer. NMIBC comprises approximately 75% to 80% of all bladder cancers, with CIS found in about 10% of cases.7

Management of CIS of the bladder remains a complex and challenging endeavor due to its high rate of recurrence and progression. Although it is typically grouped with other NMIBCs, its higher grade and aggressiveness make it a unique clinical entity. Intravesical BCG is the standard first-line treatment given its superiority to other agents; however, high rates of BCG failure highlight the need for additional therapies.8

CIS in the bladder is associated with a less favourable prognosis. It is more likely to recur after treatment. There is also a greater risk of CIS developing into Muscle Invasive Bladder Cancer ("MIBC").

On May 5, 2025 Corcept Therapeutics reported the first quarter 2025 results (Filing, 3 mnth, MAR 31, Corcept Therapeutics, 2025, MAY 5, 2025, View Source [SID1234653770]).

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On May 5, 2025, IGM Biosciences, Inc. (the "Company") reported to have received a notice of termination of that certain Collaboration and License Agreement (the "Agreement"), dated as of March 28, 2022, by and between the Company and Genzyme Corporation, a corporation organized under the laws of Massachusetts ("Sanofi"), pursuant to which Sanofi has elected to terminate the Agreement, at will, in its entirety (Filing, IGM Biosciences, MAY 5, 2025, View Source [SID1234652744]). The effective date of the termination is thirty (30) days after the date of such notice.

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Under the original terms of the Agreement, the Company had agreed to generate, develop, manufacture and commercialize IgM antibodies directed to six primary targets, three of which were oncology targets and three of which were immunology targets. The parties concluded that conducting further activities under the Agreement was not in the interests of either party.

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".

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.