CEL-SCI Corporation to Present at LD Micro "Main Event" Investor ConferenceOctober 10, 2025 8:00 AM EDT | Source: LD MicroVienna, Virginia--(Newsfile Corp. - October 10, 2025) - CEL-SCI Corporation (NYSE American: CVM), a clinical stage cancer immunotherapy company, today announced that Geert Kersten, Chief Executive Officer, is scheduled to present at the LD Micro "Main Event" Investor Conference on October 21, 2025 at 9:30 a.m. PST. The Conference is taking place at the Hotel Del Coronado in ...

Presenter: Dr. Manish Sharma, MD, Co-Director of Clinical Research, START Midwest, Grand Rapids Date: Friday, November 7, 2025 About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive AI/ML powered computational discovery platform (Unigen) to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has two proprietary product candidates in Phase 1 development: COM701, a potential first-in- ...

Core Viewpoint - Roche's Tecentriq and Tecentriq Hybreza have received FDA approval for maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC), marking a significant advancement in treatment options for this aggressive disease [1][2]. Group 1: FDA Approval and Treatment Significance - The FDA approved Tecentriq and Tecentriq Hybreza in combination with lurbinectedin for adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy [1]. - This approval represents the first and only combination therapy for first-line maintenance treatment of ES-SCLC, addressing a critical need in a disease with limited treatment options [1][6]. - The National Comprehensive Cancer Network (NCCN) has updated its guidelines to include this regimen as a category 2A preferred option for maintenance treatment [1]. Group 2: Clinical Study Results - The approval is based on the phase III IMforte study, which demonstrated that the combination therapy reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to Tecentriq alone [2][4]. - The median overall survival for the combination therapy was 13.2 months, compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio of 0.73 [2][4]. - Median progression-free survival was 5.4 months for the combination versus 2.1 months for Tecentriq alone, with a stratified hazard ratio of 0.54 [2][4]. Group 3: Background and Previous Approvals - Tecentriq was previously approved in 2019 in combination with chemotherapy for first-line treatment of adults with ES-SCLC, based on the IMpower133 study [3]. - The IMforte study enrolled 660 patients in the induction phase and randomized 483 patients in the maintenance phase, focusing on the efficacy and safety of the combination therapy [4][5].

Core Insights - OS Therapies has completed the last patient visit in its Phase 1b clinical trial for OST-504, focusing on biochemically recurrent prostate cancer, with a total of 7 patients enrolled [1][2] - The company is optimistic about the potential of OST-504 in various prostate cancer settings and plans to report study results in Q4 2025 [2] - Prostate cancer represents a significant market opportunity, with 1 in 8 men diagnosed and 1 in 44 men dying from the disease, making it the second leading cause of cancer death among men [2] - The company is also preparing for a rolling submission for a Biologics Licensing Application (BLA) for OST-HER2 in osteosarcoma, which could lead to accelerated market access for OST-504 if successful [2][5] - Updated 2-year overall survival data from the Phase 2b trial of OST-HER2 will be released on October 10, 2025 [4] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with OST-HER2 as its lead asset [3][5] - OST-HER2 has received multiple designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status, and has shown positive results in its Phase 2b clinical trial [3][5] - The company is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [6]

Company Overview - Anixa Biosciences, Inc. is a clinical-stage biotechnology company focused on cancer treatment and prevention [2] - The company has a therapeutic portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center, utilizing a novel CAR-T technology called chimeric endocrine receptor-T cell (CER-T) technology [2] - Anixa's vaccine portfolio includes vaccines for breast and ovarian cancer developed in collaboration with Cleveland Clinic, as well as additional vaccines targeting high incidence malignancies in lung, colon, and prostate cancers [2] Upcoming Event - Anixa will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 10:30 AM ET [1][2] - The presentation will take place at the Lotte New York Palace Hotel, and Mike Catelani, President and CFO, will be available for one-on-one meetings during the conference [2]

Core Insights - OS Therapies has completed a warrant inducement and exchange offer, raising approximately $3.7 million in gross proceeds to accelerate preparations for the commercial launch of OST-HER2 [1][4] - The company aims to bring OST-HER2 to market in early 2026, pending FDA regulatory approval [2] - New warrants have been issued with an exercise price of $3.00 per share, which includes a forced exercise provision when the stock trades above $9.00, potentially bringing in over $20 million in additional funding [2][4] Financial Details - The warrant exchange raised approximately $3.7 million, which will primarily be used for commercial preparations related to OST-HER2 [1][4] - The forced exercise provision of the new warrants could lead to over $20 million in additional funding if triggered [2] Product Development - OST-HER2 is the lead asset of OS Therapies, targeting osteosarcoma and has received multiple designations from the FDA, including Rare Pediatric Disease Designation [3][5] - The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025, which could lead to a Priority Review Voucher if approved [5] - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) technology, known as tunable ADC (tADC) [6]

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].

Core Insights - Anixa Biosciences is conducting a Phase 1 clinical trial for its CAR-T therapy targeting recurrent ovarian cancer, with the second patient in the fourth dose cohort treated successfully [1][3] - The fourth cohort is receiving a dose of three million CAR-positive cells per kilogram, a 30-fold increase from the initial dose, with no dose-limiting toxicities observed to date [2][4] - The CAR-T program targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells and certain cancer cells, indicating a potential for targeted therapy [3][4] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a proprietary CAR-T program developed in collaboration with Moffitt Cancer Center [5] - The CAR-T technology is differentiated by its use of the natural ligand of the FSHR receptor, FSH, which binds directly to tumor cells rather than using an antibody fragment [5] - Anixa's vaccine portfolio includes collaborations with Cleveland Clinic to develop vaccines for breast and ovarian cancer, as well as other cancers, focusing on immunizing against specific proteins expressed in cancer [5]

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]

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]