Core Insights - Anixa Biosciences has initiated dosing for the first patient in the fourth dosage cohort of its Phase 1 clinical trial for CAR-T therapy targeting recurrent ovarian cancer, marking a significant advancement in the study [1][2] - The fourth cohort will receive a dose of three million CAR-positive cells per kilogram, which is thirty times higher than the initial cohort dose, indicating a strategic escalation in dosage to assess safety and efficacy [2][4] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a specific emphasis on ovarian cancer immunotherapy developed in collaboration with Moffitt Cancer Center [4] - The company's CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which is exclusively expressed on ovarian cells and certain cancer cells, positioning it uniquely in the oncology landscape [3][4] - Anixa's business model involves partnerships with leading research institutions, allowing for the exploration of emerging technologies in cancer treatment [4]

Core Viewpoint - Anixa Biosciences, Inc. is set to host an investor webcast on June 26, 2025, to discuss its business strategy, therapeutic portfolio, market opportunities, and upcoming milestones [1][2]. Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention [4]. - The company is developing an ovarian cancer immunotherapy program in collaboration with Moffitt Cancer Center, utilizing a novel CAR-T technology called chimeric endocrine receptor-T cell (CER-T) technology [4]. - Anixa's vaccine portfolio includes vaccines for breast and ovarian cancer developed with Cleveland Clinic, as well as additional vaccines targeting high incidence malignancies in lung, colon, and prostate cancers [4]. - The company partners with renowned research institutions to explore emerging technologies for development and commercialization [4]. Webcast Details - The webcast will feature an introductory presentation by Dr. Amit Kumar, Anixa's Chairman and CEO, followed by a Q&A session for investors [2]. - Interested participants must pre-register to listen to the webcast and ask questions during the live event [3].

Core Viewpoint - Teva Pharmaceutical Industries Ltd. and Shanghai Fosun Pharmaceutical have formed a strategic partnership to develop TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy, aimed at enhancing cancer treatment efficacy while minimizing toxicity [1][2][3] Company Overview - Teva Pharmaceutical Industries Ltd. is a global biopharmaceutical leader with over 120 years of experience, focusing on innovative drug development and the production of generics and biologics [6] - Shanghai Fosun Pharmaceutical, founded in 1994, is a leading innovation-driven global healthcare company with a strong presence in pharmaceuticals and healthcare services, actively implementing its "4IN" strategy [9][10] Partnership Details - The agreement allows Fosun Pharma exclusive rights to develop, manufacture, and commercialize TEV-56278 in specific regions, while Teva retains rights in the rest of the world, facilitating global data generation [2][8] - This collaboration aims to leverage both companies' strengths, combining Teva's innovative drug development capabilities with Fosun Pharma's oncology expertise and market access in China [4][8] Product Information - TEV-56278 is designed to selectively deliver IL-2 to PD-1+ T cells, enhancing anti-tumor activity and reducing systemic toxicities, and is currently in Phase 1 trials for various cancers [5][8] - Preclinical data indicates that TEV-56278 may lead to tumor regression and improved T-cell responses, showcasing its potential as a novel cancer immunotherapy [5][8]

Core Viewpoint - TuHURA Biosciences, Inc. is set to initiate its Phase 3 accelerated approval trial for IFx-2.0 in combination with Keytruda® for advanced and metastatic Merkel cell carcinoma, following the removal of a partial clinical hold by the FDA [1][3] Group 1: Trial Details - The Phase 3 trial will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks alongside Keytruda®, compared to Keytruda® plus placebo [3] - The trial is expected to enroll 118 participants across approximately 22 to 25 U.S. sites, with a randomization ratio of 1:1 [3] - The primary endpoint is Overall Response Rate (ORR), with a key secondary endpoint of Progression Free Survival (PFS) [3] Group 2: Financial Aspects - The resolution of the partial clinical hold allows the company to unlock the second tranche of funding from a $12.5 million PIPE financing, triggering an additional payment of $2.23 million [1][3] - The company had previously announced this financing on June 3, 2025 [1] Group 3: Company Overview - TuHURA Biosciences focuses on developing novel technologies to overcome resistance to cancer immunotherapy, addressing primary and acquired resistance [4][5] - The lead product candidate, IFx-2.0, is designed to enhance the efficacy of checkpoint inhibitors [5]

Core Insights - Roche announced positive results from the Phase III IMforte study of Tecentriq in combination with lurbinectedin for extensive-stage small cell lung cancer, showing a 46% reduction in the risk of disease progression or death and a 27% reduction in the risk of death compared to Tecentriq alone [1][6]. Study Results - The IMforte study demonstrated that the combination therapy significantly extended median overall survival (OS) to 13.2 months compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio (HR) of 0.73 [2][3]. - Median progression-free survival (PFS) was also improved, with 5.4 months for the combination therapy versus 2.1 months for Tecentriq alone, yielding a stratified HR of 0.54 [2][3]. Study Design - The IMforte study was a Phase III, open-label, randomized trial involving 660 patients in the induction phase and 483 patients randomized for maintenance therapy [3][4]. - Patients received four cycles of induction therapy with Tecentriq, carboplatin, and etoposide before being randomized to maintenance therapy [3]. Safety Profile - The safety profile of the combination therapy was consistent with the known safety profiles of both Tecentriq and lurbinectedin, with no new safety signals observed [1][2]. Implications for Treatment - The results from the IMforte study are considered potentially practice-changing, offering a new option for patients with extensive-stage small cell lung cancer, a group with high unmet medical needs [2][6].

Core Insights - Roche announced positive results from the Phase III IMforte study, demonstrating that the combination of Tecentriq and lurbinectedin significantly improves survival outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC) [1][5] - The combination therapy reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to Tecentriq alone [1][5] - The study's findings were presented at the 2025 ASCO Annual Meeting and published in The Lancet, indicating a potential practice-changing option for a disease with high unmet medical needs [1][5] Study Details - The IMforte study is a Phase III, open-label, randomized trial involving 660 patients in the induction phase and 483 patients in the maintenance phase [2] - Patients received induction therapy with Tecentriq, carboplatin, and etoposide for four cycles before being randomized to maintenance therapy with either Tecentriq plus lurbinectedin or Tecentriq alone [2] - The primary endpoints of the study were progression-free survival (PFS) and overall survival (OS) assessed by independent review [2] Treatment Efficacy - The median overall survival for the Tecentriq plus lurbinectedin regimen was 13.2 months compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio of 0.73 [1][2] - Median progression-free survival was 5.4 months for the combination therapy versus 2.1 months for Tecentriq alone, with a stratified hazard ratio of 0.54 [1][2] - No new safety signals were observed, confirming the safety profiles of both Tecentriq and lurbinectedin [1][2] About Tecentriq - Tecentriq is a monoclonal antibody that targets PD-L1, designed to enhance T cell activation against tumors [3] - It is approved for various aggressive cancer types, including small cell lung cancer and hepatocellular carcinoma, and is available in both intravenous and subcutaneous forms [4][6] Roche's Commitment - Roche is a leader in cancer immunotherapy and aims to improve patient outcomes through innovative treatments [7] - The company has a long-standing commitment to sustainability and aims to achieve net zero by 2045 [8]

Core Viewpoint - Coherus Oncology has rebranded itself to emphasize its commitment to innovative immuno-oncology therapies, focusing on combination therapies to enhance cancer treatment outcomes [1][2]. Company Overview - Coherus Oncology is a commercial-stage innovative oncology company with a focus on proprietary immuno-oncology medicines [1][10]. - The company has an approved next-generation PD-1 inhibitor, LOQTORZI, which is the only FDA-approved treatment for recurrent or metastatic nasopharyngeal carcinoma in combination with chemotherapy [5][10]. Pipeline and Development - Coherus is developing a portfolio of novel combination therapies aimed at overcoming immune resistance to existing treatments [4]. - LOQTORZI serves as the foundation of the company's immuno-oncology franchise, with ongoing development for additional tumor types [5][10]. - CHS-114, a selective cytolytic CCR8 antibody, is in Phase 1b studies in combination with toripalimab for advanced solid tumors [6]. - Casdozokitug, an IL-27 antagonist, is being evaluated in a randomized Phase 2 study for advanced metastatic hepatocellular carcinoma [7]. Scientific Expertise - The company is supported by a world-class team with deep expertise in oncology drug development, including members from prestigious institutions and companies [8]. - The Scientific Advisory Board includes experts in Treg immunology and cytokine biology, providing valuable insights for navigating the oncology landscape [8].

Core Insights - TuHURA Biosciences is advancing its clinical programs, including the initiation of a Phase 3 trial for IFx-Hu2.0 in combination with Keytruda for advanced Merkel cell carcinoma (MCC) [1][3] - The company is targeting the acquisition of Kineta, Inc. and plans to initiate a Phase 2 trial for Kineta's VISTA inhibiting monoclonal antibody in NPM1-mutated acute myeloid leukemia (AML) [2][3] Clinical Development - TuHURA has initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in patients with Merkel cell carcinoma of unknown primary origin (MCCUP) [1][4] - The Phase 3 trial for IFx-Hu2.0 is expected to begin in Q2 2025, pending the lifting of a partial clinical hold by the FDA [3][10] - The Phase 1b/2a trial will include patients with deep-seated tumors who are not eligible for the Phase 3 trial, addressing a significant patient population [3][4] Financial Overview - For the first quarter ended March 31, 2025, research and development expenses were $4.6 million, compared to $3.6 million for the same period in 2024 [6] - General and administrative expenses increased to $2.4 million in Q1 2025 from $1.0 million in Q1 2024 [6] Corporate Updates - TuHURA is in the process of acquiring Kineta, Inc., with the deal expected to close in Q2 2025, subject to financing and other conditions [2][8] - The company appointed Dr. Bertrand Le Bourdonnec as Head of Drug Discovery and Dr. Craig L. Tendler to its Board of Directors, enhancing its leadership team [10] Upcoming Milestones - Q2 2025: Anticipated initiation of the Phase 3 trial for IFx-Hu2.0 and closing of the Kineta acquisition [10] - Q3 2025: Planned initiation of a Phase 2 trial for Kineta's VISTA inhibiting monoclonal antibody in NPM1-mutated AML [10]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported cash and cash equivalents of CAD 15.3 million, providing runway through key value-driving milestones and into the third quarter of 2025 [21] - Net cash used in operating activities for the quarter was CAD 6.5 million, compared to CAD 7.5 million in the same period last year, reflecting lower net operating expenditures [21][22] - The net loss for the quarter was CAD 6.7 million or CAD 0.08 per basic and diluted share, compared to a net loss of CAD 6.9 million or CAD 0.09 per share in Q1 of 2024 [22] Business Line Data and Key Metrics Changes - Research and development expenses totaled CAD 4.1 million, down from CAD 5.7 million in Q1 of 2024, primarily due to reduced manufacturing and clinical trial costs [22] - General and administrative expenses remained consistent at CAD 3 million for the first quarter [22] Market Data and Key Metrics Changes - The company is actively pursuing a CEO search to lead the development of pelareorep, which has potential in various cancer indications, including pancreatic and breast cancer [6][8] - The company showcased the versatility of pelareorep in gastrointestinal cancers at ASCO GI, with promising data presented for pancreatic and anal cancers [9][11] Company Strategy and Development Direction - The company aims to find a leader focused on clinical trial execution for pelareorep, which is seen as a valuable treatment option for difficult-to-treat malignancies [6][8] - There are plans for a registration-enabling study evaluating pelareorep in combination with paclitaxel for advanced metastatic HR positive, HER2 negative breast cancer [6][8] - The company is exploring various pathways for regulatory approval, including studies in different stages of breast cancer treatment [16][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data for pelareorep, which continues to exceed expectations, and highlighted the high unmet medical need in targeted cancer indications [6][8] - The company is optimistic about the potential for pelareorep to fulfill its promise as a treatment option for patients with several malignancies [6][8] Other Important Information - The company announced a USD 20 million share purchase agreement with Alumni Capital, providing access to capital at its discretion [23][44] - The company has received Fast Track approval from the FDA for its pancreatic cancer program, indicating regulatory support for its development efforts [27] Q&A Session All Questions and Answers Question: What can you share about the potential trial design for the breast cancer study? - The primary endpoint for the next breast cancer study is anticipated to be progression-free survival, and discussions with the FDA have been ongoing regarding the study design [26] Question: Have there been any recent interactions with the FDA regarding the pancreatic cancer program? - The FDA is aware of the pancreatic cancer program and has granted Fast Track approval, but there have been no recent discussions [27][28] Question: What areas are being prioritized in business development activities? - The company is looking for partnerships that could maximize the value of pelareorep across multiple indications, with breast and pancreatic cancer as top priorities [30] Question: Are there plans to explore additional combination approaches with immune checkpoint inhibitors? - The company has shown that pelareorep potentiates the activity of checkpoint inhibitors, particularly in pancreatic cancer, and will continue to explore this synergy [32][33] Question: Can you discuss the structure of the share purchase agreement with Alumni Capital? - The agreement provides access to capital at the company's discretion, with a minimum purchase notice set at CAD 750,000, allowing flexibility in capital management [44][45]

Forward-Looking Statements Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such ...