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

On June 3, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported that it has entered into a definitive securities purchase agreement for the issuance and sale in a private placement of an aggregate of $12.5 million of shares of its common stock, for an aggregate of 4.6 million shares, together with warrants to purchase an equal number shares of common stock at an exercise price of $3.3125 per warrant share (Press release, TuHURA Biosciences, JUN 3, 2025, View Source [SID1234653678]). The securities in the offering were sold at a combined purchase price of $2.65 per share and accompanying warrant, which represents a fifteen percent (15%) discount to the NASDAQ closing price of the Company’s common stock on June 2, 2025.

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Under the definitive agreement, approximately $9.0 million of the total offering amount will be purchased in four equal tranches based on the Company’s achievement of certain milestones (the "Initial Funding Amount"), and the remaining $3.5 million is required to be purchased and funded by December 31, 2025. One-fourth of the Initial Funding Amount will be purchased and funded at the initial closing of the offering, which is anticipated to be held on June 4, 2025 (subject to customary closing conditions), with the remaining three tranches of the Initial Funding Amount to be purchased and funded based on the achievement of the following three milestones (the "Funding Milestones") if and when the applicable milestone is achieved:

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 the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement to register the resale of the shares of common stock issuable and shares of common stock underlying the warrants no later than 60 calendar days following the date of the initial closing and to use reasonable efforts to cause such registration statement to become effective within 120 calendar days following the date of the initial closing.

In addition to the offering, the Company secured $3.0 million in additional cash proceeds from the previously disclosed February 2025 cash exercise of approximately 1.0 million warrants to purchase shares of Company common stock. The Company currently expects that the proceeds from the offering, in addition to the cash proceeds from the warrant exercises, will be sufficient to fund the Company’s cash needs for completion of the Company’s proposed merger with Kineta, Inc. contingent on the satisfaction of the Funding Milestones and the satisfaction of all other closing conditions and requirements relating to the completion of the merger.

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.

Olema Oncology Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On June 3, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported that the Company granted stock options to 11 new employees to purchase an aggregate of 322,000 shares of the Company’s common stock, effective as of June 2, 2025 (Press release, Olema Oncology, JUN 3, 2025, View Source [SID1234653677]). These awards were approved by the Compensation Committee of Olema’s Board of Directors and granted under the Company’s 2022 Inducement Plan as an inducement material to the new employees entering into employment with Olema, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options vest over four years, with 25 percent vesting on the first anniversary of the vesting commencement date for such employee and the remainder vesting in 36 equal monthly installments over the following three years, subject to the employee being continuously employed by Olema as of such vesting dates. The stock options have a 10-year term and an exercise price of $4.38 per share, equal to the last reported sale price of the Company’s common stock as reported by Nasdaq on June 2, 2025. The stock options are subject to the terms of the Olema Pharmaceuticals, Inc., 2022 Inducement Plan.

Olema is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

Karyopharm to Present at the Jefferies Global Healthcare Conference

On June 3, 2025 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team is scheduled to present at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025 at 3:10 p.m. ET in New York, NY (Press release, Karyopharm, JUN 3, 2025, View Source [SID1234653676]).

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A live webcast of the presentation along with accompanying slides can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay following the event.

Kairos Pharma Ltd. Announces New Data on Small Molecule GITR Ligand Agonist KROS 101 as Promising Cancer Immunotherapy at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting

On June 3, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical stage biopharmaceutical company, reported its presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting highlighting data on its investigational small molecule GITR ligand agonist KROS101 (Press release, Kairos Pharma, JUN 3, 2025, View Source [SID1234653675]). ASCO (Free ASCO Whitepaper) is being held May 30-June 3, 2025 at McCormick Place in Chicago, Ill.

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In the presentation titled, "Effect of KROS 101, a small molecule GITR ligand agonist, on T effector cells, T reg cells and intratumoral CD8 T cell cytotoxicity," the study authors presented their findings that demonstrated KROS 101’s capability to act as a potent glucocorticosteroid-induced tumor necrosis factor receptor (GITR) ligand agonist with dual mechanisms of action. The study authors also indicated their study showed KROS 101 enhanced T cell function by promoting proliferation and increasing cytotoxicity, enhancing the immune response by boosting cytokine production and tumor cancer cell killing. In addition, the study found that KROS101 reduced T reg-mediated suppression by reducing T reg populations, which reverses immune system suppression and enhances effector T cell activity. Further, the study showed KROS to be superior to anti-GITR antibody TRX518 in T cell tumor infiltration, T reg decrease, enhancing tumor cell cytotoxicity and preventing T cell exhaustion. TRX518 was previously in clinical trials. The presentation can be accessed here.

John Yu, M.D., Kairos CEO commented, "These results strongly support continued study of KROS101 as a cancer immunotherapy, as they show strong activity in boosting the immune system while targeting and killing tumor cells. Its dual mechanism of action provides significant opportunity to a market that remains in desperate need of new solutions. We continue to believe that KROS 101 has the potential to help optimize cancer treatment and we look forward to discussing these findings with the medical and scientific communities while providing additional progress updates as appropriate."

IMUNON Announces Data Presented at ASCO Reinforces Unprecedented Overall Survival in Ovarian Cancer Phase 2 Study

On June 3, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, reported positive data from the Company’s Phase 2 OVATION 2 Study showing that treatment with IMNN-001 in women with newly diagnosed advanced ovarian cancer resulted in consistent, clinically meaningful improvements in several key endpoints across treatment groups, including overall survival (OS), progression-free survival (PFS), chemotherapy response score and surgical response (Press release, IMUNON, JUN 3, 2025, View Source [SID1234653674]). Treatment with IMNN-001 also showed a favorable safety profile, with no reports of serious immune-related adverse events. The full results are being presented today in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois, and simultaneously published in the peer-reviewed journal Gynecologic Oncology.

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Participants with newly diagnosed advanced epithelial ovarian cancer in the Phase 2 OVATION 2 Study (n=112) were randomized 1:1 to evaluate the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) compared to standard of care (SoC) N/ACT alone, with a median follow-up of 31 months. The data being presented today highlight the consistent results achieved across all treatment groups, demonstrating:

Median 13-month increase in OS (46 vs. 33 months) and median 3-month increase in PFS (14.9 vs. 11.9 months) in IMNN-001 treatment arm compared to standard of care alone.
Better therapeutic effect observed with IMNN-001 treatment compared to the control arm (p=0.0375), as shown by mean 6.5-month extension of time free of progression or death (PFS + OS) captured in totality of treatment effect.
Use of poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy further enhanced outcomes, with median OS not yet reached in IMNN-001 treatment arm after >5 years compared to 37 months on standard of care.
Chemotherapy response score highlights double the response rate of a complete or near complete histopathological response following treatment with 26.1% in the IMNN-001 treatment arm compared to 13.0% in the control arm.
Surgical response rate of no macroscopic residual tumor left after surgery 64.6% in the IMNN-001 treatment arm compared to 52.1% in the control arm.
Hazard ratio of 0.78 in study participants who are homologous recombination proficient (HRP) and hazard ratio of 0.42 in women positive for homologous recombination deficiency (HRD+), including BRCA1 or BRCA2 mutations, suggesting increased therapeutic activity.
IMNN-001 was generally safe and well tolerated, with no reports of cytokine release syndrome, systemic toxicity or serious immune-related adverse events (AEs). The most common AEs primarily included abdominal pain, nausea and vomiting.
"These data highlighting the consistency of results across all treatment groups are a true testament to the power of our TheraPlas technology and the potential of IMNN-001 to transform the treatment paradigm of women who are newly diagnosed with advanced ovarian cancer and in desperate need of new treatment options," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "Results were consistent across a variety of participants, including women who receive PARP inhibitors, who are HRP and HRD positive, and who have BRCA1 and BRCA2 mutations. We are grateful for the continued support and participation of study participants and investigators and look forward to advancing our pivotal Phase 3 OVATION 3 trial of IMNN-001, with the first two trial sites recently initiated."

The OVATION 2 Study oral presentation and journal manuscript will both be available on the "Scientific Presentations" page of IMUNON’s website at View Source

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.