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OS Therapies Terminates Equity Line of Credit
Newsfile· 2025-08-26 01:51
Core Viewpoint - OS Therapies has terminated its Equity Purchase Agreement with Square Gate Capital Master Fund, effective August 26, 2025, and has successfully raised $4.2 million through a warrant exercise inducement and exchange offering to fund operations into mid-2026 [1][2]. Group 1: Financial Developments - The termination of the Equity Purchase Agreement (ELOC) with Square Gate Capital Master Fund is effective August 26, 2025 [1]. - The company raised $4.2 million in gross proceeds from a recent warrant exercise inducement and exchange offering, which will support operations through mid-2026 [2]. Group 2: Clinical Trials and Product Development - The treatment phases of the Phase 2b OST-HER2 clinical trial in osteosarcoma and the Phase 1b OST-504 clinical trial in prostate cancer are now complete, leading to a projected monthly burn rate in the second half of 2025 that is significantly lower than in the first half [3]. - OS Therapies plans to allocate capital primarily to drive towards approval for OST-HER2 in osteosarcoma while analyzing data from OST-504 for future development steps [3]. Group 3: Company Overview and Product Pipeline - OS Therapies is focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset, OST-HER2, leveraging immune-stimulatory effects to target the HER2 protein [4]. - OST-HER2 has received multiple designations from the U.S. FDA, including Rare Pediatric Disease Designation and Fast-Track designation, and the company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025 [4]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced delivery of therapeutic payloads [5].
TuHURA Biosciences, Inc. Reports Second Quarter 2025 Financial Results and Provides a Corporate Update
Prnewswire· 2025-08-14 20:15
Core Insights - TuHURA Biosciences has completed the acquisition of Kineta, Inc. and its VISTA inhibiting monoclonal antibody, now named TBS-2025, with plans to initiate a Phase 2 trial in relapsed/refractory NPM1-mutated Acute Myeloid Leukemia (AML) in the second half of 2025 [1][4] - The company has initiated a Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy with Keytruda® for advanced and metastatic Merkel cell carcinoma (MCC), under a Special Protocol Assessment (SPA) agreement with the FDA [1][3] Corporate Highlights - TuHURA completed a $12.5 million equity financing transaction and received an additional $3 million from warrant exercise proceeds [2][5] - The company was included in the Russell 3000® and Russell 2000® Indexes as of June 27, 2025 [4] Clinical Development - The Phase 3 trial of IFx-2.0 is a single randomized placebo-controlled trial that could potentially meet the requirements for both accelerated and full approval without the need for a post-accelerated approval confirmatory trial [3] - A Phase 1b/2a trial has been initiated for IFx-2.0 as an adjunctive therapy in first-line treatment of checkpoint-naïve patients with MCC of unknown primary origin, targeting newly diagnosed patients with metastatic tumors [3] Financial Performance - Research and development expenses for the second quarter of 2025 were $4.9 million, compared to $2.8 million for the same period in 2024 [7] - Net cash outflows from operating activities for the first half of 2025 were ($10.9) million, compared to ($8.9) million for the same period in 2024 [7] Upcoming Milestones - The company plans to advance TBS-2025 into a randomized Phase 2 trial in the second half of 2025 [6] - TuHURA anticipates providing updates on enrollment progress in its Phase 3 trial of IFx-2.0 by the end of 2025 and topline results from the Phase 1b/2a trial in Q1 2026 [12]
Anixa Biosciences Announces Dr. Robert Wenham will speak about Immunotherapy in surviving Ovarian Cancer at the 13th Annual Ovarcoming Cancer Conference
Prnewswire· 2025-08-08 13:15
Core Insights - Anixa Biosciences, Inc. is advancing its CAR-T therapy for ovarian cancer, with Dr. Robert Wenham as the principal investigator for the ongoing Phase 1 clinical trial [1][4] - Dr. Wenham will present at the 13th Annual Ovarcoming Cancer Conference, discussing advancements in ovarian cancer research and therapies, including Anixa's CAR-T therapy [2] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [4] - The company utilizes a novel CAR-T technology known as chimeric endocrine receptor-T cell (CER-T) technology, which differentiates itself by using the natural ligand of the FSHR receptor [4] - Anixa's vaccine portfolio includes collaborations with Cleveland Clinic to develop vaccines for breast and ovarian cancer, as well as other cancers [4] Conference Details - The Ovarcoming Cancer Conference aims to unite survivors, caregivers, and medical professionals to learn from experts in the ovarian cancer field [3] - Dr. Wenham's presentation is scheduled for September 18, 2025, from 12:05 PM to 12:30 PM CT [2]
BioNTech Announces Second Quarter 2025 Financial Results and Corporate Update
Globenewswire· 2025-08-04 10:45
Core Insights - BioNTech reported significant advancements in its oncology strategy, including collaborations and acquisitions aimed at enhancing its product pipeline and capabilities [2][6][30] - The company experienced a substantial increase in revenues for the second quarter of 2025, driven primarily by its COVID-19 vaccine collaboration [3][4] - BioNTech's financial position remains strong, with substantial cash reserves and expected cash inflows from strategic partnerships [10][11][14] Financial Performance - Revenues for Q2 2025 reached €260.8 million, up from €128.7 million in Q2 2024, while total revenues for the first half of 2025 were €443.6 million compared to €316.3 million in the prior year [3][4] - The net loss for Q2 2025 was €386.6 million, a significant reduction from a net loss of €807.8 million in Q2 2024, with a total net loss of €802.4 million for the first half of 2025 compared to €1,122.9 million in the same period last year [7][8] - Basic and diluted loss per share improved to €1.60 for Q2 2025 from €3.36 in Q2 2024, and for the first half of 2025, it was €3.33 compared to €4.67 in the prior year [8][41] Research and Development - R&D expenses for Q2 2025 were €509.1 million, down from €584.6 million in Q2 2024, with total R&D expenses for the first half of 2025 at €1,034.7 million compared to €1,092.1 million in the previous year [4][5] - The company is focusing on its oncology pipeline, including the development of BNT327, a bispecific antibody candidate, and has initiated several clinical trials for various cancer treatments [6][23][27] Strategic Developments - BioNTech entered a collaboration with Bristol Myers Squibb (BMS) for the co-development of BNT327, which includes an upfront cash payment of $1.5 billion and potential milestone payments totaling up to $7.6 billion [10][11][12] - The acquisition of CureVac is expected to enhance BioNTech's capabilities in mRNA technology, complementing its existing product offerings [2][6][30] - The company has received approval for a new variant-adapted COVID-19 vaccine, with preparations for launch underway [6][22] Financial Guidance - BioNTech reaffirmed its revenue guidance for the full year 2025, expecting revenues to be between €1,700 million and €2,200 million, with a focus on late-stage development and commercialization in oncology [14][16] - Planned expenses for 2025 include R&D expenses of €2,600 million to €2,800 million and SG&A expenses of €650 million to €750 million [15][16]
Anixa Biosciences Announces Issuance of Additional U.S. Patent for Ovarian Cancer Vaccine Technology
Prnewswire· 2025-07-09 12:00
Core Viewpoint - Anixa Biosciences has announced the issuance of a key patent for its ovarian cancer vaccine technology, which is expected to enhance the company's position in the cancer treatment market [1][4]. Group 1: Patent and Technology - The United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,357,593 on July 15, 2025, covering methods related to eliciting an immune response targeting anti-Müllerian hormone receptor, type II (AMHR2) [1]. - The patent includes methods for administering an immunogenic composition that encodes the AMHR2 polypeptide, specifically targeting the extracellular domain of human AMHR2 [3]. - Anixa holds exclusive worldwide rights to the patent, which was issued to Cleveland Clinic [3]. Group 2: Collaboration and Development - The ovarian cancer vaccine is being developed in collaboration with Cleveland Clinic and the National Cancer Institute, focusing on high-risk populations such as those with BRCA mutations [2]. - Anixa's therapeutic portfolio includes an ovarian cancer immunotherapy program utilizing chimeric endocrine receptor-T cell (CER-T) technology, which is distinct from traditional CAR-T therapies [4]. - The company is also developing additional cancer vaccines in collaboration with Cleveland Clinic to address various cancers, including breast, lung, colon, and prostate cancers [4].
Anixa Biosciences to Host an Investor Webcast on June 26, 2025
Prnewswire· 2025-06-20 11:30
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].
Teva and Fosun Pharma Enter into a Strategic Partnership to Develop Novel Anti-PD1-IL2 Therapy (TEV-56278) in Immuno-Oncology
Globenewswire· 2025-06-16 12:30
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]
Roche’s Tecentriq combined with lurbinectedin shows significant survival benefit in extensive-stage small cell lung cancer
Globenewswire· 2025-06-03 05:00
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].
Roche's Tecentriq combined with lurbinectedin shows significant survival benefit in extensive-stage small cell lung cancer
GlobeNewswire News Room· 2025-06-03 05:00
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]
Coherus Completes Strategic Transformation to Coherus Oncology, Focusing Exclusively on Innovative Cancer Therapeutics
Globenewswire· 2025-05-30 12:00
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].