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TuHURA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Corporate Update

On April 1, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported financial results for the Company’s fourth quarter and full year ended December 31, 2025, and provided a corporate update.

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"2025 was a strong year of executing upon our goals, and we continue to move all our programs forward this year. As we progress our clinical development pipeline, we have strategically strengthened our clinical and drug development expertise with Craig Tendler, M.D., providing the strategic and operational services consistent with those of a Chief Medical Officer to oversee clinical development strategy and operations of the company’s pipeline, including our VISTA inhibiting antibody, TBS-2025," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "Craig brings a depth of experience that is invaluable to us as we look forward to several targeted key milestones in our VISTA program this year. Our IFx-2.0 Phase 3 study in front-line Merkel Cell Carcinoma (MCC) continues to enroll, and we now anticipate completing enrollment in mid-2027. Additionally, we continue to make important advancements toward preclinical proof-of-concept in our first-in-class immune modulating antibody drug conjugates (ADC) program and anticipate presenting new data at a scientific conference later this year."

Dr. Bianco continued, "We are grateful to have the unwavering support of our shareholders, who are committed to supporting our programs and realizing the potentially meaningful opportunity each one addresses."

Corporate Highlights

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Initiated a randomized Phase 3 Accelerated Approval Trial for IFx-2.0 in first line treatment of patients with advanced or metastatic Merkel Cell Carcinoma (MCC) as adjunctive therapy to Keytruda (pembrolizumab). Phase 3 study trial being conducted under a Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA). Primary endpoint of Overall Response Rate (ORR) qualifies for accelerated approval process. Key secondary endpoint of Progression Free Survival (PFS) may satisfy the requirement for a post confirmatory trial, converting accelerated approval to regular approval.

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Initiated Phase 1b/2a Study of IFx-2.0 as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP). Trial designed to evaluate the safety and feasibility of IFx-Hu2.0 in combination with Keytruda when administered via Interventional Radiology (IR) in patients with deep- seated tumors without associated cutaneous tumors.

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Closed acquisition of Kineta gaining rights to TBS-2025, a novel VISTA inhibiting antibody, for $10.5 million.

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Raised gross proceeds of $21.2 million in registered direct offerings and private placements

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Presented data demonstrating the Delta Opioid Receptor (DOR) as a new target in overcoming acquired resistance to immune checkpoint inhibitors at ASH (Free ASH Whitepaper). Selected for Oral Presentation by the Scientific Committee of American Society of Hematology (ASH) (Free ASH Whitepaper) new scientific evidence that DOR is expressed on tumor-associated Myeloid-Derived Suppressor Cells (MDSCs), and its inhibition decreases immune suppressing capabilities of MDSCs by downregulating expression of multiple genes associated with MDSC induced immunosuppression. Data also presented in the poster session demonstrated that the DOR is also expressed on tumor associated macrophages (TAMs) and DOR inhibition appears to reverse TAM mediated T cell suppression with the potential to overcome resistance to checkpoint inhibitors and other cancer immunotherapies.

Upcoming Targeted Milestones by Program

IFx-2.0 (Innate immune agonist)

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1H 2026: Anticipate Orphan Drug Designation for IFx-2.0 in MCC
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2H 2026: Anticipate preliminary data from the Phase1b/2a study of IFx-2.0 as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP)
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2H 2027: Anticipate topline results from the Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for advanced or metastatic MCC

TBS-2025 (VISTA inhibiting antibody)

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June 2026: Meeting with the FDA to discuss the development plan for TBS-2025 in NPM1 mut r/r AML

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2H 2026: Anticipate initiation of Phase 1b/2 trial of VISTA in NPM1 mut r/r AML

Lead ADC Selection

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1H 2026: Select lead ADC in AML
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2H 2026: Expect to initiate ADC in vivo proof of concept (POC) studies
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2H 2026: Anticipate POC data in humanized model of AML
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2H 2026: Presentations at key scientific meetings

Summary of Financial Results for the Full Year 2025

Cash and cash equivalents of $3.6 million at December 31, 2025, with an additional $7.5 million received in Q1 2026 from the 2025 registered direct offering. As of December 31, 2025, TuHURA’s total shares outstanding were approximately 52.9 million.

Research and development expenses were $20.5 million and $13.3 million for the 12 months ended December 31, 2025, and 2024, respectively. On a pro forma basis, which includes a full year of Kineta research and development, these expenses were $22.1 million and $18.7 million for the 12 months ended December 31, 2025, and 2024, respectively.

General and administrative (G&A) expenses were $7.6 million and $3.9 million for the 12 months ended December 31, 2025, and 2024, respectively.

Net cash outflows from operating activities were ($27.7) million and ($14.7) million for the 12 months ended December 31, 2025, and 2024, respectively.

Net cash flows from financing activities were $19.9 million and $29.7 million for the 12 months ended December 31, 2025, and 2024, respectively.

(Press release, TuHURA Biosciences, APR 1, 2026, View Source [SID1234664128])

Pasithea Therapeutics Announces Grant of Fast Track Designation by FDA to PAS-004 for Treatment of Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) Causing Significant Morbidity

On April 1, 2026 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PAS-004 for the treatment of NF1-associated PN causing significant morbidity.

"We appreciate the FDA’s decision that PAS-004 meets the criteria for Fast Track designation for this indication," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "The ability to have early and frequent interactions with the FDA supports our goal to expeditiously develop PAS-004 for patients with NF1-associated PN causing significant morbidity."

Fast Track designation includes the following opportunities to facilitate Fast Track product development:

Frequent communications with the FDA review team throughout the product development process

Rolling Review, which allows portions of a marketing application to be reviewed and assessed by the FDA before the company submits the complete application

In addition, a Fast Track designation product may potentially be eligible for accelerated approval and/or priority review if relevant criteria are met. For more information, see the FDA’s website at
View Source

The Company is currently conducting a Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004 in adult participants with symptomatic, inoperable, incompletely resected, or recurrent NF1-PN (NCT06961565).

About NF1- PN

Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.

(Press release, Pasithea Therapeutics, APR 1, 2026, View Source [SID1234664127])

Orca Bio Announces FDA Review Extension of BLA for Orca-T for the Treatment of Hematologic Malignancies

On April 1, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that the U.S. Food and Drug Administration (FDA) has extended the review timeline of its Biologics License Application (BLA) for Orca-T for the treatment of patients with hematologic malignancies. The new Prescription Drug User Fee Act (PDUFA) target action date is July 6, 2026.

The extension follows Orca Bio’s recent submission of updated chemistry, manufacturing and controls (CMC) information in response to requests from the FDA as part of the standard review process. The FDA classified the submission as a Major Amendment (MA) to the BLA, which extends the review by three months. Importantly, the FDA has not requested any additional clinical data. Orca Bio believes that the updated information submitted in the amendment does not affect the benefit-risk conclusions of the BLA.

"We appreciate the frequent engagement with the FDA throughout the review process," said Nate Fernhoff, co-founder and chief executive officer at Orca Bio. "Our continued focus is on preparing for the potential approval and commercial launch of Orca-T. We remain committed to working with the Agency, physicians and the broader blood cancer community to deliver this important therapy to patients with hematologic malignancies as quickly as possible."

The BLA for Orca-T was granted Priority Review by the FDA and Orca-T previously received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation.

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified hematopoietic stem cells, regulatory T-cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA).

(Press release, Orca Bio, APR 1, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-announces-fda-review-extension-of-bla-for-orca-t-for-the-treatment-of-hematologic-malignancies [SID1234664126])

Oncolytics Biotech® Completes Domicile Change to the United States

On April 1, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported the completion of the previously announced change in the jurisdiction of incorporation of Oncolytics from the Province of Alberta in Canada to the State of Nevada in the United States (the "Domestication") through a series of transactions in which the Company first continued its existence from the Province of Alberta in Canada to the Province of British Columbia in Canada on March 17, 2026. The Company will retain its office in Calgary, while the San Diego office will become the Company’s new headquarters.

The Domestication was approved by the Company’s shareholders at the Special Meeting of Shareholders held on January 15, 2026. The Company completed the Domestication on March 31, 2026, when necessary filings were submitted to, and made effective by, the Nevada Secretary of State. The Company’s common stock will continue to trade on The Nasdaq Stock Market LLC under the ticker symbol "ONCY." Effective today, the CUSIP number applicable to the Company’s common stock will be 68237V 103, and the ISIN will be US68237V1035.

Today, most of the Company’s investors, management team, and capital markets activity are U.S.-based. We expect this transition to bring several benefits to the Company and its stockholders, including greater operational efficiency, a streamlined regulatory structure, and improved access to U.S. capital markets.

"We are encouraged by the potential benefits that Nevada’s corporate legal environment presents to biotech companies, especially given our focus on operational efficiency across the company," said Jared Kelly, Chief Executive Officer of Oncolytics. "As we no longer qualified as a "foreign private issuer" under applicable U.S. securities laws, it made sense to overhaul our corporate structure and change Oncolytics’ jurisdiction of incorporation to reflect its status as a U.S. domestic issuer. While our clinical data and regulatory strategy will ultimately give us the best opportunity to create long-term value, we believe our new corporate structure will streamline our ability to execute on our goals."

(Press release, Oncolytics Biotech, APR 1, 2026, View Source [SID1234664125])

FORE Biotherapeutics Receives Breakthrough Therapy Designation for Plixorafenib

On April 1, 2026 FORE Biotherapeutics, a registration stage company dedicated to developing targeted therapies to treat patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to plixorafenib for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG). Fore Bio believes this is the first BTD granted to a targeted therapy for HGG. Plixorafenib is a novel BRAF inhibitor that is a dimer breaker with high selectivity for BRAF alterations.

The FDA granted this BTD based on data from approximately 25 patients treated in the completed Phase 1/2a clinical trial and ongoing Phase 2 FORTE basket evaluating plixorafenib in BRAF V600E-mutated central nervous system (CNS) tumors. The CNS tumors treated in FORTE include HGG, low-grade gliomas (LGG), and other primary brain and spinal cord tumors in adults and children. BTD is designed to speed the development and regulatory review of new medicines that are intended to treat a serious or life-threatening condition and that have shown encouraging early results, which demonstrate substantial improvement on one or more clinically significant endpoints (e.g., improved efficacy or improved safety with similar efficacy, etc.), over available therapies.

"High-grade gliomas are aggressive primary brain tumors associated with poor outcomes despite multimodality treatment approaches," said Macarena da la Fuente M.D., Chief, Neuro-Oncology Division, Department of Neurology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine. "In addition to their limited prognosis, patients experience substantial morbidity related to both the disease itself and the toxicities of current therapies. Therefore, there remains a critical need for novel treatments that are not only effective but also better tolerated."

"The granting of Breakthrough Therapy Designation is a significant development milestone for plixorafenib and reinforces our conviction in its unique mechanism of action which, further supported by the tolerability and efficacy profile seen in BRAF-altered tumors, underscores the potential of plixorafenib as a treatment option for patients living with difficult to treat cancers," said Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore. "BRAF alterations are an important actionable driver in the molecularly integrated clinical decision paradigm for the treatment of high-grade gliomas, and plixorafenib has demonstrated a differentiated profile in patients with primary CNS tumors, including glioblastoma and other high-grade gliomas. The maturation of the data from FORTE may help validate these findings, with BTD status further accelerating the delivery of this promising therapy to patients. We look forward to continued collaboration with the FDA to further advance plixorafenib and to advancing our FORTE basket trial in several types of BRAF altered malignancies."

Data from the Phase 1/2a trial, which were previously presented at ASCO (Free ASCO Whitepaper) 2023 and SNO 2023, show that plixorafenib achieved a 67% overall response rate (ORR) in a pre-specified subgroup of patients with refractory MAPK inhibitor naive BRAF V600-mutated primary CNS tumors with robust anti-tumor activity further supported by duration of response (DOR), and clinical benefit rate (CBR) across BRAF-altered tumor types and CNS histologies. As of the last reporting, the BRAF V600E primary CNS basket of the FORTE study met the pre-specified interim analysis, with the Independent Data Monitoring Committee (IDMC) supporting that the study may continue as planned on the basis of responses assessed by blinded independent central review (BICR), in addition to the IDMC’s ongoing oversight for safety.

BTD provides Fore with more frequent and intensive guidance from and dialogue with the FDA, including the involvement of senior reviewers, as well as eligibility for rolling and priority review of the marketing application. These benefits have the potential to accelerate the development and review of plixorafenib.

Plixorafenib previously received Fast Track Designation for the treatment of patients with cancers harboring BRAF Class 1 (V600) and Class 2 (including fusions) alterations who have exhausted prior therapies and Orphan Drug Designation (ODD) for the treatment of primary brain and CNS malignancies. These, in addition to the BTD, continue to support the development of plixorafenib for the treatment of BRAF-altered primary CNS tumors in adults and children as the broader data set from FORTE continues to mature to provide a sufficient number of patients to support a robust benefit-risk profile across refractory high grade and low grade CNS biomarker-selected histologies.

About the Global Phase 2 FORTE Basket Study
The registration-intended FORTE Master Protocol is a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are recurrent or progressive BRAF V600 primary CNS tumors, solid tumors with BRAF fusions and rare BRAF V600 mutated solid tumors. As part of the Bayesian adaptive design of the trial, interim efficacy analyses are conducted in each basket, for which the company reported a positive outcome from the BRAF V600 CNS basket in the third quarter of 2025.

About BRAF Altered Recurrent Primary CNS Tumors
BRAF altered recurrent primary CNS tumors represent a high unmet medical need and a large market opportunity for plixorafenib. In the advanced treatment setting, patients are offered currently approved therapies, but those therapies have significant limitations in efficacy, tolerability, and safety.

About Plixorafenib
Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. In a previously conducted Phase 1/2 study, in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. In patients with V600 alterations who were MAPK inhibitor naïve, plixorafenib achieved a 42% response rate with prolonged duration of response (mDOR 17.8 months), with a clinical benefit rate of >70%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore believes plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors through its unique mechanism of action targeting BRAF, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor.

(Press release, Fore Biotherapeutics, APR 1, 2026, View Source [SID1234664123])