Core Insights - Compugen Ltd. is a clinical-stage cancer immunotherapy company that utilizes AI/ML for predictive computational drug target discovery [3][4] - The company will participate in a fireside chat at the Stifel 2025 Healthcare Conference on November 11, 2025 [1] - Compugen has two proprietary product candidates in Phase 1 development: COM701 and COM902, targeting cancer treatment [3] Company Overview - Compugen is headquartered in Israel with additional offices in San Francisco, CA [3] - The company is listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN [3] - Compugen's therapeutic pipeline includes early-stage immuno-oncology programs aimed at activating the immune system against cancer [3] Upcoming Events - A live webcast of the fireside chat will be available on the Investor Relations section of Compugen's website [2] - A replay of the event will also be accessible after the live session [2] Product Development - COM701 is a potential first-in-class anti-PVRIG antibody, while COM902 is a potential best-in-class antibody targeting TIGIT for solid tumors [3] - Rilvegostomig, a PD-1/TIGIT bispecific antibody, is in Phase 3 development by AstraZeneca under a licensing agreement [3] - GS-0321, a high affinity anti-IL-18 binding protein antibody, is also in Phase 1 development and licensed to Gilead [3]

Core Insights - Nxera Pharma reported strong progress in its strategic focus on obesity and metabolic diseases, highlighting the launch of a proprietary pipeline led by an oral GLP-1 agonist and multiple GPCR-targeted programs [2][3] - The company achieved significant milestones in partnered programs, including a US$10 million payment from AbbVie for a multi-target discovery collaboration focused on neurological diseases [3][6] Operational Highlights - Nxera's proprietary pipeline includes an oral small molecule GLP-1 agonist and six additional GPCR-targeted programs aimed at optimizing metabolic efficacy and sustaining weight reduction [7] - The first patient has been dosed in a Phase 2a trial for HTL0039732, an investigational cancer immunotherapy [7] - Manufacturing approval was received for an additional site in Asia for QUVIVIQ, expected to improve profitability through cost reductions [7] Financial Performance - For the nine-month period ended 30 September 2025, revenue totaled JPY 21,848 million (US$147.4 million), a decrease of JPY 135 million compared to the prior period, attributed to smaller individual milestone receipts despite more milestone events [6][12] - R&D expenses increased to JPY 11,200 million (US$75.6 million), reflecting higher investment in R&D and the impact of a weaker Yen [12] - The company reported an operating loss of JPY 5,907 million (US$39.9 million), compared to a loss of JPY 2,846 million (US$18.8 million) in the prior period [12]

Core Insights - CEL-SCI Corporation is scheduled to present its strategic roadmap for Multikine at the LD Micro "Main Event" Investor Conference on October 21, 2025 [1][2] Company Overview - CEL-SCI Corporation is a clinical stage cancer immunotherapy company focused on enhancing the immune system's ability to target tumors before surgical interventions [3] - The company operates in Vienna, Virginia, and near Baltimore, Maryland [5] Product Information - Multikine (Leukocyte Interleukin, Injection) is a first-line cancer therapy that has been administered to over 740 patients and has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck [4] - The FDA has approved CEL-SCI to conduct a confirmatory Registration Study for Multikine, which will enroll 212 patients with newly diagnosed locally advanced resectable head and neck cancer [4] - The target patient population for this study is estimated to represent about 100,000 patients annually [4]

Core Insights - Roche announced positive results from the phase III IMvigor011 study, showing that Tecentriq significantly improves overall survival and disease-free survival in muscle-invasive bladder cancer patients at risk of recurrence after surgery [1][3][6] Study Results - Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared to placebo [1][6] - At a median follow-up of 16.1 months, median disease-free survival (DFS) was 9.9 months for the Tecentriq group versus 4.8 months for the placebo group, with a stratified hazard ratio of 0.64 [3][4] - Median overall survival (OS) was 32.8 months for the Tecentriq group compared to 21.1 months for the placebo group, with a hazard ratio of 0.59 [3][4] Study Design - The IMvigor011 study was a global phase III, randomized, placebo-controlled, double-blind trial involving 761 participants, focusing on those with detectable circulating tumor DNA (ctDNA) [4] - The study utilized Natera's Signatera ctDNA test to guide treatment decisions, currently under FDA review as a companion diagnostic [4] Clinical Implications - The results indicate that ctDNA-guided treatment can help identify patients who would benefit from adjuvant therapy, potentially leading to more personalized treatment approaches [3][4] - More than 150,000 people are diagnosed with muscle-invasive bladder cancer annually, highlighting the need for effective treatment strategies [3]

Core Viewpoint - CEL-SCI Corporation is set to present its strategic roadmap for the development of Multikine at the LD Micro "Main Event" Investor Conference on October 21, 2025 [1][2]. Company Overview - CEL-SCI Corporation is a clinical stage cancer immunotherapy company focused on enhancing the immune system's ability to target tumors before surgical interventions [3]. - The company operates in Vienna, Virginia, and near Baltimore, Maryland [5]. Product Information - Multikine (Leukocyte Interleukin, Injection) is a first-line cancer therapy that has been administered to over 740 patients and has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck [4]. - A completed randomized controlled Phase 3 study involving 928 patients has led to FDA approval for a confirmatory Registration Study, which will enroll 212 patients with newly diagnosed locally advanced resectable head and neck cancer [4]. - The target patient population for this study is approximately 100,000 patients annually, specifically those with no lymph node involvement and low PD-L1 tumor expression [4].

Core Insights - Compugen Ltd. is advancing its clinical-stage cancer immunotherapy with the presentation of a first-in-human trial for the anti-IL18BP antibody, COM503 (GS-0321), at the upcoming SITC Annual Meeting in November 2025 [1][2]. Company Overview - Compugen is a clinical-stage therapeutic discovery and development company that utilizes AI/ML-powered computational discovery to identify new drug targets and biological pathways for cancer immunotherapies [2]. - The company has two proprietary product candidates in Phase 1 development: COM701, an anti-PVRIG antibody, and COM902, an antibody targeting TIGIT for solid tumors [2]. - Rilvegostomig, a PD-1/TIGIT bispecific antibody, is in Phase 3 development by AstraZeneca under a licensing agreement [2]. - GS-0321 (previously COM503) is a high-affinity anti-IL-18 binding protein antibody in Phase 1 development, licensed to Gilead [2]. - Compugen's pipeline includes early-stage immuno-oncology programs aimed at activating the immune system against cancer [2]. - The company is headquartered in Israel with additional offices in San Francisco, CA, and is listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN [2].

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]