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ImmunityBio Confirms Statistical Power in Pivotal Randomized BCG-Naïve NMIBC Trial to Detect Clinically Meaningful Differences Between ANKTIVA® Plus BCG Versus BCG Alone; Supplemental BLA Submission on Track for 2026

On March 26, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated, commercial-stage immunotherapy company, reported that based on the Independent Data Monitoring Committee (IDMC) review of the interim data, the committee recommended that the study is adequately powered to detect the pre-specified clinically meaningful difference in complete response (CR) rate between the experimental arm (ANKTIVA + BCG) and the control arm (BCG alone) at the protocol-specified power, in the randomized QUILT-2.005 (NCT02138734) study. The QUILT-2.005 study was designed to detect the pre-specified difference in CR rate between ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) and BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease, based on its review of the planned interim analysis.

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On February 26, 2026, ImmunityBio announced enrollment was complete in the pivotal randomized trial. By March 2026, 50% of enrolled patients were evaluable (N=183) for the primary efficacy endpoint. Upon reaching this pre-specified 50% evaluable threshold, a planned interim analysis by an IDMC was initiated per protocol to verify that the 366 patients enrolled to date provides sufficient statistical power to detect the pre-specified clinically meaningful difference in CR rate between the two arms.

Based on the IDMC review of the interim data, the committee recommended that no additional enrollment beyond N=366 is required and that the study is adequately powered to detect the pre-specified clinically meaningful difference in CR rate at the protocol-specified power.

"Over the past decade, our scientific thesis has been that activating natural killer cells and CD8+ cytotoxic T cells through IL-15 receptor agonism would generate durable immunological memory against bladder cancer. The NCI identified IL-15 as the number one ranked immunostimulatory cytokine nearly two decades ago, and this program has been the clinical validation of that thesis. The IDMC’s confirmation that QUILT-2.005 is adequately powered to detect clinically meaningful differences when ANKTIVA is combined with BCG. Among participants from the QUILT 2.005 Phase 1b study which began in 2014, those patients who enrolled in long-term follow-up (6 of 9 evaluable), all (6 out of 6, 100%) demonstrated a prolonged duration of complete remission with a median survival of 8.8 years with ongoing bladder preservation to date. In addition, the initial interim analysis of QUILT-2.005 performed in the first 43 patients in 2023, further demonstrated a difference in durable complete response when ANKTIVA is combined with BCG in the BCG-naïve setting. The consistency of durable response from the first 9 patients in 2014, to the next 43 patients in 2023 is encouraging and I am pleased that statistical power of the randomized trial requires no further enrollment," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. "The combination of ANKTIVA with BCG is approved for adult patients with BCG-unresponsive NMIBC with CIS with or without papillary disease, and the enrollment of QUILT-2.005 is now complete. ImmunityBio is on track to submit a supplemental Biologics License Application based on the final data analysis in 2026."

"The regulatory and commercial development of ANKTIVA in urologic oncology and across solid tumor indications continues to advance. We are grateful to the patients who participated in this trial and to the ImmunityBio team whose work made this milestone possible," said Richard Adcock, President and CEO of ImmunityBio. "With ANKTIVA approved with BCG for adult patients with BCG-unresponsive NMIBC CIS with or without papillary disease in 34 countries and territories, the opportunity to extend its use earlier in the disease course in the BCG-naïve setting represents a substantial expansion of the addressable patient population."

About QUILT-2.005

QUILT-2.005 (NCT02138734) is a randomized, controlled Phase 2b clinical trial evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC). BCG-naïve patients are those receiving BCG-based therapy for the first time, representing an earlier stage of treatment than the BCG-unresponsive population for whom ANKTIVA is currently FDA approved. The trial is designed to assess whether the addition of ANKTIVA to standard induction BCG improves the complete response (CR) rate in patients with carcinoma in situ (CIS) with or without papillary disease. QUILT-2.005 completed enrollment in February 2026. In March 2026, the Independent Data Monitoring Committee determined that the study was adequately powered to detect a clinically meaningful difference between the control and experimental arms. Supplemental BLA submission is anticipated Q4 2026.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the dendritic cell membrane-bound IL-15 receptor alpha driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, MAR 26, 2026, View Source [SID1234663942])

HOOKIPA Pharma Announces Completion of Sale of Oncology Assets to NeoTrail Therapeutics

On March 26, 2026 HOOKIPA Pharma Inc. (OTCID: HOOK, "HOOKIPA", the "Company") reported the completion of the sale of its immuno-oncology related assets, consisting primarily of the HB-200 (eseba-vec) and HB-700 development programs, to NeoTrail Therapeutics, Inc. ("NeoTrail"). The purchase price remains undisclosed. The asset purchase agreement was signed on January 28, 2026, and the closing of the transaction occurred on March 20, 2026.

About HB-200
Eseba-vec (also known as HB-200) is an investigational immunotherapeutic agent being evaluated for HPV16 positive cancers. HB-200 alternates the administration of both HB-201 (LCMV) and HB-202 (PICV), collectively referred to as "HB-200," attenuated viral vectors, which on their own are replicating-based therapeutics expressing a non-oncogenic, but highly immunogenic, E7E6 fusion protein from HPV16. Positive preliminary data from a Phase 2 trial (NCT04180215) of HB-200 in combination with pembrolizumab in patients with recurrent/metastatic HPV16 positive head and neck cancers in the first line setting was presented in November 2024 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference. Trial close out activities were completed before the end of 2025. HB-200 received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency. HB-200 was developed using HOOKIPA’s proprietary arenavirus platform.

About HB-700
HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most prevalent KRAS mutations (G12D, G12V, G12R, G12C and G13D) and has the potential to benefit more patients than single mutation inhibitors. HB-700 received Investigational New Drug application clearance from the Food and Drug Administration in April 2024 and is Phase 1 ready, with clinical trial material manufacturing completed.

(Press release, Hookipa Pharma, MAR 26, 2026, View Source [SID1234663941])

FoRx Therapeutics Presents Preclinical Data at ACS Spring 2026, Confirming FORX-428’s Potential for Best-in-Class PARG Inhibition

On March 26, 2026 FoRx Therapeutics, a clinical-stage biotechnology company developing precision anti-cancer therapeutics, reported the presentation of the molecular structure, discovery, and preclinical data supporting the potential best-in-class profile of its PARG inhibitor, FORX-428, currently in Phase 1 development, at the American Chemical Society (ACS) Spring 2026 meeting in Atlanta.

This disclosure of the novel molecular structure of FORX-428 represents the first description of the discovery and chemical structure of a clinical-stage PARG inhibitor candidate.

Data presented at ACS Spring 2026 showed FORX-428’s differentiated preclinical profile relative to a competitor reference compound, including superior selectivity and pharmacokinetics (PK), with potency shown to be at least 10-fold higher across multiple solid tumor cell lines. FORX-428 has demonstrated the potential for a best-in-class profile, supported by favorable preclinical safety and toxicology data and a promising predicted human PK profile.

In preclinical studies, FORX-428 showed robust anti-tumor activity in hard-to-treat models across three distinct target populations: HRD-positive, PARP inhibitor-resistant, and high replication stress tumors. By comparison, the reference compound showed activity primarily in highly sensitive models.

Tarig Bashir, CEO of FoRx Therapeutics, said: "The robust preclinical data presented at ACS Spring 2026 support FORX-428’s best-in-class potential and why we believe it has the potential to meaningfully improve treatment options for patients. Our ongoing Phase 1 trial is progressing according to plan toward an initial clinical readout in the coming months."

The discovery that distinct genetic subsets of cancer are exceptionally vulnerable to drugs that interfere with the DNA Damage Response (DDR) led to the approval of PARP inhibitors more than 10 years ago, transforming cancer treatment. FoRx is pursuing PARG as a next-generation DDR target with significant potential as a new treatment approach for patients whose cancers are resistant to, or have become resistant to, PARP inhibitors.

The Phase 1 trial of FORX-428 is progressing as planned, with initial data readout expected in mid- 2026. The open-label study, which began recruitment in August 2025 and is being conducted at leading cancer centers in the United States, is evaluating safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors who have exhausted standard-of-care options.

ACS Spring 2026 is taking place in Atlanta, Georgia, USA, from March 22 to 26.

FORX-428 is designed to inhibit the poly (ADP-ribose) glycohydrolase (PARG) enzyme to cause tumor cell death. PARG is a key DNA repair enzyme necessary for the survival of certain genetically defined cancers, harboring specific DDR deficiencies or high replication stress. Preclinical studies demonstrated that FORX-428 has robust anti-tumor activity across multiple solid tumor types, underscoring the novel compound’s promising potential in both monotherapy and combination settngs. Importantly, FORX-428 was well tolerated, demonstrating drug-like pharmacology and a favorable safety profile.

(Press release, FoRx Therapeutics, MAR 26, 2026, View Source [SID1234663940])

Can-Fite Reports 2025 Financial Results and Ongoing Clinical Progress Highlighting Positive Data in Phase 2a Pancreatic cancer and 9 Years Cancer-Free Survival in Liver Cancer Patient

On March 26, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported clinical updates and financial results for the year ended December 31, 2025 and early 2026.

Advances in Clinical Programs

Pancreatic Cancer

Phase 2a study in pancreatic cancer met its primary endpoint of safety in heavily pretreated patients. The study continues to follow patients for overall survival, with data maturing over time; currently more than 30% of patients are alive at last data cut-off.

Hepatocellular Carcinoma (HCC)

A patient with advanced HCC, treated with Namodenoson has reached an overall survival of more than 9 years with complete response to treatment. The patient was enrolled into a Phase 2 study and continues to be treated with Namodenoson through a compassionate use program. Nine years following treatment, the patient remains cancer-free and meets the definition of a complete responder based on the disappearance of all tumor lesions and good quality of life. Namodenoson continues to advance in a Phase 3 study for hepatocellular carcinoma, supported by Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, reinforcing its potential as a novel therapeutic option in liver oncology.

Clinical Progress in Decompensated Liver Cirrhosis

The Company observed complete resolution of esophageal varices in a patient with decompensated cirrhosis—an uncommon outcome in this population, along with overall clinical stabilization. The patient subsequently underwent successful liver transplantation following prolonged treatment, supporting the potential role of Namodenoson as a disease-modifying therapy and a bridge to transplant in end-stage liver disease.

Expansion into Metabolic and Obesity Indications

The Company expanded Namodenoson’s therapeutic potential into metabolic diseases, including obesity, supported by new scientific findings and patent allowances. These developments further highlight the versatility of the A3 adenosine receptor (A3AR) platform and its applicability across multiple high-value indications.

Strengthening of Intellectual Property Portfolio

Can-Fite continued to expand its global intellectual property estate with multiple patent allowances across key territories, including Israel, Canada, and Brazil, covering novel therapeutic uses of Namodenoson. These additions further strengthen the Company’s long-term commercial positioning and pipeline value.

Motti Farbstein Can-Fite’s CEO&CFO stated: "The past months have marked a period of significant progress for Can-Fite, highlighted by encouraging clinical signals across multiple indications and continued expansion of our intellectual property portfolio. Notably, clinical observations in advanced liver disease suggest that Namodenoson may have the potential to modify disease course and serve as a bridge to transplantation. Together with our advancing oncology programs and expanding metabolic pipeline, we believe these developments position Can-Fite for meaningful value creation in the near and long term."

Financial Results

Revenues

Revenues for the year ended December 31, 2025 were $0.41 million, a decrease of $0.27 million, or 40% compared to $0.67 million for the year ended December 31, 2024. The decrease in revenues was mainly due to the recognition of a lower portion of advance payments received under the Ewopharma distribution agreement entered in 2021 and a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.

Research and development expenses

Research and development expenses for the year ended December 31, 2025 were $6.69 million, an increase of $0.9 million, or 16.26% compared to $5.75 million for the year ended December 31, 2024. Research and development expenses for the year ended December 31, 2025 comprised primarily of expenses associated with the ongoing of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH. The increase is primarily due to acceleration in expenses associated with both Namodenoson and Piclidenoson.

General and administrative expenses

General and administrative expenses were $3.66 million for the year ended December 31, 2025, an increase of $0.6 million, or 20.2% compared to $3.04 million for the year ended December 31, 2024. The increase is primarily due to the increase in investors relationship expenses. We expect that general and administrative expenses will remain at the same level through 2026.

Financial income, net

Financial income, net for the year ended December 31, 2025 aggregated $0.12 million compared to $0.25 million for the year ended December 31, 2024. The decrease in financial income, net was mainly due to lower income on short term deposits.

Net loss for the year ended December 31, 2025 was $9.83 million compared with a net loss of $7.88 million for the year ended December 31, 2024. The increase in net loss for the year ended December 31, 2025 was primarily attributable to an increase in research and development expenses and an increase in general and administrative expenses.

As of December 31, 2025, Can-Fite had cash and cash equivalents and short term deposits of $8.54 million as compared to $7.88 million at December 31, 2024. The increase in cash during the year ended December 31, 2025 is mainly due to higher net cash provided by financing activities. On March 4, 2026, the Company received aggregate gross proceeds of approximately $4.3 million from warrant exercises and a warrant inducement.

The Company’s consolidated financial results for the year ended December 31, 2025 are presented in accordance with US GAAP Reporting Standards.

More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2025, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at View Source as well as via the Company’s investor relations website at View Source The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 26 Ben Gurion Street, Ramat Gan, 5257346, Israel or by phone at +972-3-9241114.

(Press release, Can-Fite BioPharma, MAR 26, 2026, View Source [SID1234663938])

Alivexis and Astellas Pharma Inc. to Collaborate on Novel Drug Target

On March 26, 2026 Alivexis, Inc. (Headquartered in Minato-ku, Tokyo; CEO S. Roy Kimura) reported that it has entered into a Research Collaboration Agreement with Astellas Pharma Inc. ("Astellas"), representing the second collaboration program between the two companies. It follows the initial collaboration launched in June 2024, under which Astellas exercised its option in September 2025 to obtain rights to the research outcomes.

The collaboration aims to utilize Alivexis’ computational drug discovery platform, including ModBind, to discover new small molecule compounds which will regulate the function of a novel drug target molecule selected by Astellas. In addition to in silico evaluation using the computational drug discovery platform, Alivexis will be responsible for integrated drug discovery research, including the development of experimental assays and compound evaluation using those assays. Under the terms of the collaboration, Astellas will have the option to acquire rights to the research deliverables.

About ModBind.
ModBind is a proprietary physics-based simulation technology developed by Alivexis that enables high-speed, highly accurate prediction of absolute binding strength between small molecule compounds and target proteins, without the need for experimentally-derived biological activity data. Leveraging ModBind along with other platform technologies, we have already advanced five compounds to clinical candidate status. MDI-0151 program resulted in a licensing agreement with a Swiss company in June 2024, valued at approximately 42.5 billion yen, demonstrating the practical and commercial utility of our technology. In addition, we have conducted multiple joint research projects with pharmaceutical companies, with ModBind serving as the core technology in these collaborations.
In addition, we were selected for the third round of the "GENIAC (Generative AI Accelerator Challenge)" program, a project led by the Ministry of Economy, Trade and Industry (METI) and the New Energy and Industrial Technology Development Organization (NEDO) which aims to strengthen domestic development capabilities in generative AI. By integrating ModBind with AI training, we aim to build and implement a generative AI foundation model for drug discovery that predicts the biological activity of small-molecule compounds with world-leading accuracy. In addition, the company is advancing collaborative research with pharmaceutical companies utilizing these platform technologies and has already generated multiple outcomes.

【CEO S. Roy Kimura’s Comments】
"I am excited to announce the signing of a second drug discovery collaboration with Astellas focused on the use of our proprietary and ground-breaking ModBind simulation technology to accelerate early drug discovery for a selected disease target. Through our collaboration, we look forward to gaining further validation of our technology while contributing to the discovery of novel clinical candidate compounds for diseases with significant unmet medical needs."

(Press release, Alivexis, MAR 26, 2026, View Source [SID1234663937])