Summary of Oncolytics Biotech Key Opinion Leader Webinar Company and Industry - **Company**: Oncolytics Biotech - **Industry**: Oncology, specifically focusing on pancreatic cancer and other gastrointestinal cancers Core Points and Arguments 1. **Introduction of Pelareorep**: Pelareorep is an oncolytic virus that selectively targets cancer cells and is administered intravenously, making it easier for widespread application compared to other oncolytic viruses that require intratumoral administration [6][7][8] 2. **Efficacy in Pancreatic Cancer**: Pelareorep has shown strong efficacy signals in pancreatic cancer, with a 62% overall response rate observed in clinical studies, which is significantly higher than traditional chemotherapy combinations [15][34] 3. **Unmet Need in Pancreatic Cancer**: Pancreatic cancer is the 10th most common cancer but the second leading cause of cancer death, highlighting the urgent need for effective treatments [10][11] 4. **Current Treatment Landscape**: Standard treatments include gemcitabine and FOLFIRINOX, with limited overall survival rates. Pelareorep combined with chemotherapy has shown improved survival rates compared to historical controls [12][13][22] 5. **Safety Profile**: Over 1,100 patients have been treated with Pelareorep, showing a favorable safety profile with mild side effects such as flu-like symptoms, indicating it is well-tolerated [66][70] 6. **Combination Therapy Potential**: Pelareorep can be combined with various chemotherapy regimens and checkpoint inhibitors, enhancing its therapeutic potential across multiple cancer types [86] 7. **Goblet Trial**: The Goblet trial is a significant study evaluating Pelareorep in combination with gemcitabine, nab-paclitaxel, and atezolizumab, showing promising early results [34][35] 8. **Biomarker Insights**: Tumor-infiltrating lymphocyte expansion has been identified as a potential biomarker correlating with treatment response, suggesting a mechanism of action that enhances immune response [40][41] Other Important but Possibly Overlooked Content 1. **Durability of Response**: The durability of responses in patients treated with Pelareorep is a notable characteristic, indicating potential long-term benefits [15] 2. **Mechanism of Action**: Pelareorep induces endoplasmic reticulum stress in pancreatic cancer cells, leading to apoptosis, which supports its mechanism of action [20] 3. **Future Directions**: There is a strong interest in exploring Pelareorep in registration-enabling studies for first-line treatment in pancreatic cancer, given the promising efficacy and safety data [57][69] 4. **Cross-Tumor Potential**: Pelareorep has demonstrated efficacy across various tumor types, including breast and colorectal cancers, indicating its potential as a versatile therapeutic agent [86] This summary encapsulates the key insights and discussions from the Oncolytics Biotech webinar, focusing on the promising role of Pelareorep in treating pancreatic cancer and its potential applications in other cancers.

Core Insights - American Oncology Network (AON) is expanding access to Bispecific T-cell Engager (BiTE) therapy across more than 40 partner clinics in 18 states and Washington, D.C., enhancing treatment options for hard-to-treat cancers [1][4] - Bispecific therapies represent a significant advancement in cancer treatment by engaging the immune system to target cancer cells more effectively [2][7] - AON's commitment to integrating innovative therapies like bispecific antibodies into their offerings aims to improve patient outcomes for challenging cancers [3][9] Company Overview - AON is a rapidly growing network of community oncology practices, founded in 2018, representing over 290 providers across 21 states [11] - The organization focuses on value-based care, aiming to improve patient outcomes while reducing costs and expanding access to quality care [11] - AON is dedicated to promoting health equity and addressing disparities in cancer care, ensuring all patients have access to necessary treatments [11] Treatment Details - Bispecific therapies work by dual targeting, engaging T cells to increase immune activity at tumor sites, and enhancing the immune response while minimizing damage to healthy tissue [7] - Since March 2025, AON has provided bispecific antibody therapy for various cancers, including acute lymphoblastic leukemia and multiple myeloma [3][4] - AON's implementation of BiTE therapies allows patients to receive advanced treatments in community settings, reducing the need for travel to major medical centers [4][9] Clinical Trials and Research - AON actively participates in clinical trials and collaborates with leading researchers to explore new applications of bispecific antibodies in oncology [8]

Core Viewpoint - SAB BIO has successfully raised $175 million in an oversubscribed private placement financing to fund its pivotal Phase 2b SAFEGUARD study for SAB-142, aimed at delaying the progression of autoimmune type 1 diabetes (T1D) in newly diagnosed patients [2][5]. Group 1: Financing Details - The private placement includes participation from strategic investor Sanofi and several new investors such as RA Capital Management, Commodore Capital, and Blackstone Multi-Asset Investing, among others [1][3]. - The financing agreement allows for the issuance of up to 1,000,000 shares of Series B nonvoting convertible preferred stock, convertible into up to 100,000,000 shares of common stock at a price of $1.75 per share [4]. - There is potential for an additional $284 million in gross proceeds if milestone-based warrants are fully exercised [2][4]. Group 2: Use of Proceeds - The net proceeds from the private placement will be used to fully fund the Phase 2b SAFEGUARD study of SAB-142 and for working capital and general corporate purposes [5]. - The combined proceeds from the private placement and the company's current cash are expected to extend the cash runway into the middle of 2028 [5]. Group 3: Company Overview - SAB BIO is a clinical-stage biopharmaceutical company focused on developing human anti-thymocyte immunoglobulin (hIgG) to treat autoimmune T1D [2][9]. - The company's lead asset, SAB-142, aims to change the treatment paradigm for T1D by delaying onset and potentially preventing disease progression [9][10].

Core Viewpoint - BioNTech SE will announce its financial results for the second quarter of 2025 on August 4, 2025, and will host a conference call and webcast for stakeholders to discuss these results and provide a corporate update [1]. Group 1: Financial Results Announcement - The financial results for Q2 2025 will be disclosed on August 4, 2025 [1]. - A conference call and webcast will take place at 8:00 a.m. EDT (2:00 p.m. CEST) on the same day [1]. Group 2: Accessing the Conference Call - Participants can register for the live conference call via a provided link, with dial-in numbers and a PIN sent post-registration [2]. - It is recommended to register at least one day in advance for the call [2]. - The slide presentation and audio of the webcast will be accessible through a specified link [2]. Group 3: Company Overview - BioNTech is a global next-generation immunotherapy company focused on developing novel therapies for cancer and serious diseases [4]. - The company utilizes a variety of computational discovery and therapeutic modalities for rapid biopharmaceutical development [4]. - BioNTech's oncology product candidates include mRNA cancer immunotherapies, immunomodulators, and targeted therapies such as antibody-drug conjugates and CAR T cell therapies [4]. - The company is also developing multiple mRNA vaccine candidates for infectious diseases alongside its oncology pipeline [4]. - BioNTech has established collaborations with various global pharmaceutical companies, including Bristol Myers Squibb, Pfizer, and Genentech [4].

Core Points - BioNTech SE announced the resignation of Ryan Richardson as Chief Strategy Officer effective September 30, 2025, to pursue new professional opportunities [1] - Richardson joined BioNTech in 2018 and has been instrumental in raising over USD 1 billion through various financing activities, including the Initial Public Offering on Nasdaq [2] - His contributions include building Global Strategy and Corporate Development functions, enhancing Capital Markets and Investor Relations, and serving on the Board of Directors of InstaDeep Ltd. since its acquisition in 2023 [2] Company Overview - BioNTech is a global next-generation immunotherapy company focused on developing novel therapies for cancer and other serious diseases [4] - The company has a diversified oncology product portfolio, including mRNA cancer immunotherapies, immunomodulators, and targeted therapies such as antibody-drug conjugates and CAR T cell therapies [4] - BioNTech collaborates with various global pharmaceutical companies, including Bristol Myers Squibb, Pfizer, and Genentech, to advance its research and development efforts [4]

Core Insights - Lisata Therapeutics and WARPNINE have completed patient enrollment in the Phase 1b/2a iLSTA trial, evaluating certepetide in combination with standard-of-care chemotherapy and immunotherapy for locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC) [1][2] - The trial is significant as it targets an earlier stage of PDAC, where immunotherapy has been largely ineffective [2] - Preliminary data from the trial presented at ESMO-GI indicated a 60% overall response rate and a 100% overall disease control rate after four treatment cycles [3][4] Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [7] - Certepetide, the company's proprietary product candidate, is designed to enhance the delivery of anti-cancer drugs to solid tumors and has shown favorable safety and clinical activity in trials [6][7] - The company has received multiple designations for certepetide, including Fast Track and Orphan Drug Designations for pancreatic cancer in the U.S. and E.U. [6] Trial Details - The iLSTA trial is randomized, single-blind, and conducted at St John of God Subiaco Hospital, a leading center for clinical research in Australia [2][3] - Participants were divided into three cohorts, with varying combinations of standard-of-care chemotherapy and immunotherapy [2] - The trial aims to assess the efficacy of certepetide in improving treatment outcomes for patients with locally advanced PDAC [2][4] Preliminary Data Highlights - After four treatment cycles, 13 out of 20 participants showed a partial response, and one participant exhibited a complete response [3] - 16 out of 20 participants experienced a decrease in CA19-9 levels, a tumor marker, with several showing significant reductions [3] - No participants showed an increase in tumor size, indicating a positive response to the treatment [3] Collaboration and Support - The collaboration between Lisata and WARPNINE combines global expertise with local clinical execution to address urgent needs in pancreatic cancer treatment [2] - AstraZeneca is involved in providing drug supply, enhancing the trial's operational capabilities [2] - The successful completion of patient enrollment reflects the commitment of both organizations to advance treatment options for patients with PDAC [4]

Core Viewpoint - BriaCell Therapeutics Corp. has successfully closed a public offering of 12 million units, raising gross proceeds of $15 million to support its cancer immunotherapy development [1][3]. Group 1: Offering Details - The offering consisted of 12,000,000 units, each unit priced at $1.25, which includes one common share or one pre-funded warrant and one warrant [1]. - Each pre-funded warrant allows the purchase of one common share at an exercise price of $0.001, while each warrant is exercisable at $1.50 per share for five years [1]. - The offering was conducted without a Canadian prospectus, relying on an exemption under the TSX Company Manual [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital, general corporate purposes, and advancing business objectives [3]. Group 3: Regulatory Information - A registration statement on Form S-1 was filed with the SEC and became effective on July 15, 2025, with the offering made only by means of a prospectus [4].

Core Viewpoint - Akeso, Inc. has initiated a Phase III clinical trial for ivonescimab as a first-line treatment for advanced metastatic colorectal cancer (mCRC), addressing a significant unmet clinical need in this area [1][2][7]. Industry Overview - Colorectal cancer is the third most common cancer globally and the second leading cause of cancer-related deaths, with over 1.9 million new cases and approximately 904,000 deaths reported in 2022 [3]. - About 95% of mCRC cases are classified as microsatellite stable (MSS) or proficient mismatch repair (pMMR), which traditionally show poor responses to immunotherapy [3]. - Current standard treatments for mCRC include chemotherapy combined with targeted therapies, but the overall efficacy remains limited, with a five-year survival rate for advanced patients of less than 20% [4]. Company Initiatives - The Phase III trial (AK112-312/HARMONi-GI6) aims to validate the clinical benefits of ivonescimab, which has shown promising Phase II efficacy data in combination with chemotherapy for MSS/pMMR-type mCRC [5][7]. - The combination of ivonescimab with FOLFOXIRI demonstrated an overall response rate (ORR) of 81.8% and a disease control rate (DCR) of 100%, indicating compelling anti-tumor activity in this difficult-to-treat patient population [6]. Future Prospects - If successful, ivonescimab could provide a novel first-line immunotherapy treatment option for patients with advanced mCRC, potentially improving outcomes compared to existing therapies [7].

Core Insights - Citius Oncology has executed a distribution services agreement with Cencora to enhance its commercial infrastructure for the FDA-approved immunotherapy LYMPHIR [1][2][3] - The agreement aims to expand Citius Oncology's distribution network, ensuring product availability upon launch and supporting long-term scalability [2][3] - LYMPHIR is indicated for relapsed or refractory cutaneous T-cell lymphoma (CTCL) and is a targeted immune therapy that has shown antitumor activity [4][5] Company Overview - Citius Oncology is a majority-owned subsidiary of Citius Pharmaceuticals, focusing on developing and commercializing novel targeted oncology therapies [29][30] - The FDA approved LYMPHIR in August 2024, with an estimated initial market exceeding $400 million, indicating significant growth potential in an underserved market [29][30] - Citius Pharmaceuticals also has a late-stage pipeline that includes other critical care products, demonstrating a diverse portfolio [30] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a recombinant fusion protein that targets IL-2 receptors, leading to cell death in tumors expressing these receptors [4][5] - The product is indicated for adult patients with r/r Stage I-III CTCL after at least one prior systemic therapy [8][29] - The drug has received regulatory approval in Japan for CTCL and peripheral T-cell lymphoma (PTCL) prior to its FDA approval [5]

Core Insights - BriaCell Therapeutics Corp. has added Mayo Clinic as a key clinical site for its ongoing pivotal Phase 3 clinical study in metastatic breast cancer [1][2] - The Phase 3 study now includes 69 active clinical sites across 15 states, enhancing the reach and potential patient enrollment for the trial [2] - The study evaluates BriaCell's lead candidate, Bria-IMT™, in combination with an immune checkpoint inhibitor against physician's choice in advanced metastatic breast cancer [3][4] Study Details - The primary endpoint of the study is overall survival (OS), with interim data analysis planned after 144 patient events (deaths) occur [4] - BriaCell has previously announced positive Phase 2 survival data for a similar patient population treated with the Bria-IMT combination regimen [4] - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential significance in cancer treatment [4] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [6]