Company Overview - Lisata Therapeutics is a clinical stage pharmaceutical company focused on developing innovative therapies for cancer and other serious diseases[8] - The company's mission is to rapidly develop and commercialize innovative treatments that improve outcomes for patients with cancer or other serious diseases[10] - Lisata has a proprietary field-leading technology with global IP protection extending beyond 2040[12] - The company projects multiple product and business milestones over the next 12 months[12] - Lisata has existing partnerships that validate its platform technology, with potential for many others[12] - The company's cash runway extends into 1Q 2027 with no debt[12] Certepetide Development and Clinical Trials - Certepetide is designed to optimize solid tumor treatment by converting tumor stroma, reducing immunosuppression, and inhibiting metastasis[23, 24] - In mPDAC, two Phase 1b/2a trials showed that Certepetide plus SoC chemotherapy improved overall survival[73] - In the ASCEND Phase 2b study, Cohort A showed a median overall survival of 12.68 months with Certepetide + SoC compared to 9.23 months with Standard of Care[87] - In the ASCEND Phase 2b study, Cohort B showed a median PFS of 7.46 months with Certepetide + SoC compared to 5.29 months with Standard of Care, nearing statistical significance (HR 0.61, p=0.09)[91, 92] - The iLSTA Phase 1b/2a trial in locally advanced PDAC with chemo & IO showed an Overall Response Rate of 69% in Cohort 3[110] Financial Position - As of June 30, 2025, Lisata had $22 million in cash and investments[140]

Summary of Lisada Therapeutics Conference Call Company Overview - **Company Name**: Lisada Therapeutics (NasdaqCM:LSTA) - **Industry**: Clinical stage pharmaceutical company focused on solid tumor cancer treatment - **Management Team**: Over 200 years of combined experience in drug development across big pharma and emerging companies [2][3] Core Points and Arguments - **Market Need**: Over 90% of newly diagnosed cancers are solid tumors, with a growing prevalence, particularly pancreatic cancer, which is projected to become the second leading cause of cancer death in the U.S. by the end of the decade [4] - **Product Development**: The company is developing **Sotepatide**, a proprietary cyclic peptide designed to penetrate tumor stroma and reduce immunosuppressive environments, enhancing the efficacy of various anticancer therapies [5][6] - **Intellectual Property**: Strong IP portfolio protecting products until 2040, with several strategic alliances and licenses established [3][9][8] - **Clinical Trials**: - Completed Phase 2B and is Phase 3 ready for metastatic pancreatic ductal adenocarcinoma (MPDAC) [12] - Significant improvement in overall survival by 5-6 months compared to standard care, representing a 150% improvement [14] - Cohort A and B data from trials show promising results in overall survival and progression-free survival (PFS) [18][20] - Positive preliminary data from the I LISTA study combining Sotepatide with chemotherapy and immunotherapy [23] Financial Position - **Cash Reserves**: Approximately $20 million available, with a cash runway extending into early 2027 [30] - **Debt-Free**: The company maintains a clean capital structure [30] Regulatory Status - **Designations**: Fast track designation in the U.S. for pancreatic cancer, orphan designations in both the U.S. and Europe, and rare pediatric disease designation for osteosarcoma [27] - **Phase 3 Protocol**: Approved by the FDA, with ongoing discussions with the EMA for global registration [28] Additional Insights - **Combination Therapy**: Sotepatide can be used with various anticancer modalities, showing improved efficacy without increasing safety risks [21][22] - **Future Studies**: Ongoing studies in other cancers, including cholangiocarcinoma and gastroesophageal adenocarcinoma, with data expected in the near future [29] - **Market Strategy**: Plans to raise capital for further development and potential licensing agreements to enhance product offerings [27] Conclusion Lisada Therapeutics is positioned strongly within the oncology market, with innovative therapies addressing significant unmet medical needs, a solid financial foundation, and a robust pipeline of clinical data supporting its product efficacy and safety. The company is actively pursuing strategic partnerships to enhance its market presence and therapeutic offerings [31]

Core Insights - Immutep Limited announced positive results from the EFTISARC-NEO Phase II trial, demonstrating significant efficacy of eftilagimod alfa (efti) in combination with radiotherapy and KEYTRUDA® for resectable soft tissue sarcoma (STS) [1][5] - The trial met its primary endpoint, achieving a median tumor hyalinization/fibrosis of 51.5%, significantly exceeding the prespecified target of 35% [1][5] - The results indicate a potential for improved overall survival and recurrence-free survival in STS patients, addressing a substantial unmet medical need in this area [2][5] Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, particularly leveraging LAG-3 [7] - The company aims to provide innovative treatment options and maximize shareholder value through its diversified product portfolio [7] Clinical Trial Details - The EFTISARC-NEO Phase II trial was investigator-initiated and involved a diverse population of STS subtypes, showcasing a robust safety profile with minimal severe toxicity [1][2] - The study was primarily funded by a grant from the Polish government through the Polish Medical Research Agency program [2] Eftilagimod Alfa (Efti) Mechanism - Efti is an MHC Class II agonist that activates antigen-presenting cells, stimulating both adaptive and innate immune responses to combat cancer [4][6] - The therapy is under evaluation for various solid tumors, including non-small cell lung cancer and head and neck squamous cell carcinoma, with favorable safety allowing for multiple combination therapies [6]

Core Insights - Immutep Limited is focusing on changing the treatment paradigm for first-line non-small cell lung cancer (1L NSCLC) through innovative immunotherapy approaches [1][5]. Clinical Trial Results - The INSIGHT-003 trial demonstrated strong objective response rates (ORR) and disease control rates (DCR) for the combination of eftilagimod alfa (efti) with KEYTRUDA (pembrolizumab) and chemotherapy in patients with advanced or metastatic non-squamous 1L NSCLC [2][5]. - The ORR for patients with low and no PD-L1 expression (TPS <50%) reached 61.7%, significantly higher than the historical control of 40.8% [3][5]. - The combination therapy showed high ORR and DCR across all PD-L1 expression levels, with specific rates of 54.5% (no PD-L1), 68.0% (low PD-L1), and 75.0% (high PD-L1) [4]. Safety and Efficacy - The combination of efti with KEYTRUDA and chemotherapy has a favorable safety profile and has shown promising clinical responses, particularly in patients with low or absent PD-L1 expression [3][5]. - Efti is expected to set a new standard of care for 1L NSCLC patients, supported by data from multiple clinical trials, including the pivotal TACTI-004 Phase III trial [5][8]. Future Developments - The TACTI-004 Phase III trial is a global study enrolling approximately 756 patients with advanced/metastatic 1L NSCLC, evaluating the same immunotherapy/chemotherapy combination used in INSIGHT-003 [5][6]. - Efti is under evaluation for various solid tumors, including head and neck squamous cell carcinoma and breast cancer, and has received Fast Track designation from the FDA for first-line treatments [8]. Company Overview - Immutep is a late-stage biotechnology company specializing in novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in Lymphocyte Activation Gene-3 (LAG-3) [9].

Full Dose Expansion Data for Solnerstotug in PD-(L)1 Resistant Tumors October 20, 2025 Presenters: Dr. Kyriakos Papadopoulos Co-Director of Clinical Research START, San Antonio Principal Investigator for Ph1 trial of Solnerstotug John Celebi Chief Executive Officer Ron Weitzman Chief Medical Officer Disclaimer This presentation has been prepared by Sensei Biotherapeutics, Inc. (the "Company," "we," "us") and is made for informational purposes only. The information set forth herein does not purport to be com ...

Core Insights - BriaCell Therapeutics Corp. announces positive clinical biomarker data from its ongoing pivotal Phase 3 study of Bria-IMT combined with an immune checkpoint inhibitor for metastatic breast cancer, presented at the ESMO Congress 2025 [1][2] Study Details - The Phase 3 study involves randomizing patients in a 1:1:1 ratio to receive Bria-IMT + CPI, Treatment of Physician's Choice, or Bria-IMT monotherapy, with pooled data available from 113 patients who had a median of 6 prior treatment lines [3] - The study continues to evaluate safety and progression-free survival (PFS) among all patients, with no treatment-related discontinuations reported due to adverse events [5][11] Biomarker Findings - Neutrophil to Lymphocyte Ratio (NLR) is identified as a potential biomarker, showing significantly higher PFS in patients with NLR between 0.7 and 2.3 (4.5 months) compared to those with NLR < 0.7 or > 2.3 (2.5 months) [4] - Similar encouraging trends in biomarkers from the Phase 2 study are observed in the ongoing Phase 3 study [11] Future Prospects - Interim data analysis will occur once 144 patient events (deaths) are recorded, focusing on overall survival as the primary endpoint, with positive results potentially leading to full approval and marketing authorization for Bria-IMT in metastatic breast cancer [7]

Core Insights - Medicenna Therapeutics Corp. is a clinical-stage immunotherapy company focused on developing Superkines for cancer and autoimmune diseases, participating in several upcoming conferences to showcase its innovative therapies and engage with the investment community [1][5]. Upcoming Conference Participation - Medicenna will participate in the Planet MicroCap Showcase in Toronto in 2025, BIO-Europe 2025 in Vienna, and the Oppenheimer Miami Oncology Summit [2][3][4]. - The BIO-Europe event is one of the largest life sciences partnering events, providing Medicenna a platform to engage with potential partners and investors [7]. - The Oppenheimer Miami Oncology Summit will focus on oncology advancements, allowing Medicenna to discuss its immunotherapy innovations [7]. Company Overview - Medicenna is developing novel, highly selective versions of IL-2, IL-4, and IL-13 Superkines, including the long-acting IL-2 Superkine, MDNA11, which preferentially stimulates cancer-killing effector T cells and NK cells [5]. - The IL-4 Empowered Superkine, bizaxofusp, has been studied in five clinical trials with over 130 patients, including a Phase 2b trial for recurrent GBM, and has received FastTrack and Orphan Drug status from the FDA and EMA [5]. - Medicenna's early-stage BiSKITs™ and T-MASK™ programs aim to enhance the effectiveness of Superkines in treating immunologically "cold" tumors [5].

Solid Tumor Spotlight: TGFβR2xPD-1 Bi-specific Antibody and KRAS G12D Inhibitor ESMO 2025 October 19, 2025 Forward looking statements Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including any discussion of the potential and opportunities presented by INCA33890 and INCB161734 and plans for further development of the same. These forward-looking statements are based on Incyte's current expecta ...

Core Insights - Ivonescimab combined with chemotherapy demonstrated a 40% reduction in the risk of disease progression or death compared to Tislelizumab plus chemotherapy in the first-line treatment of patients with squamous non-small cell lung cancer (NSCLC) in the HARMONi-6 study [1][5][33] - The median progression-free survival (PFS) was 11.14 months for Ivonescimab plus chemotherapy versus 6.90 months for Tislelizumab plus chemotherapy, with a hazard ratio of 0.60 [1][5][6] - The safety profile of Ivonescimab was comparable to Tislelizumab, with similar rates of serious treatment-related adverse events (TRAEs) and discontinuation due to TRAEs [1][7][9] Study Overview - The HARMONi-6 trial was a Phase III, multi-center study conducted in China, evaluating Ivonescimab in combination with platinum-based chemotherapy against Tislelizumab plus chemotherapy in patients with advanced squamous NSCLC, regardless of PD-L1 expression [2][4][33] - The study was sponsored by Akeso, Inc., with all relevant data generated and analyzed by Akeso [2][4] Efficacy Results - Ivonescimab showed a statistically significant improvement in PFS, with a hazard ratio of 0.60 (95% CI: 0.46, 0.78; p<0.0001) [5][6] - The overall response rate (ORR) was 75.9% for Ivonescimab plus chemotherapy compared to 66.5% for Tislelizumab plus chemotherapy [6] - Duration of response (DoR) was also longer for Ivonescimab at 11.20 months versus 8.38 months for Tislelizumab [6] Safety Profile - The safety profile of Ivonescimab was manageable, with 3.4% of patients discontinuing due to TRAEs compared to 4.2% for Tislelizumab [9][11] - Serious TRAEs occurred in 32.3% of patients receiving Ivonescimab and 30.2% for Tislelizumab [11] - Grade 3 or higher immune-related adverse events were reported in 9.0% of Ivonescimab patients versus 10.2% for Tislelizumab [11] Future Studies - The HARMONi-3 global study will analyze squamous and non-squamous NSCLC cohorts separately, with enrollment completion expected in the first half of 2026 for the squamous cohort and the second half of 2026 for the non-squamous cohort [1][19][20] - An interim analysis for overall survival is planned for both cohorts upon reaching the prespecified number of events [19][20] Publication and Presentation - The results of the HARMONi-6 trial were published in The Lancet and presented at the European Society for Medical Oncology (ESMO) 2025 Congress [1][13][24]

As Filed with the Securities and Exchange Commission on October 17, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Classification Code Number) Delaware 2834 87-0455038 (I.R.S. Employer Identification Number) 1900 Lake Park Drive, Suite 380, Smyrna, Georgia 30080, (678) 384-7220 (Address, incl ...