Core Insights - Indaptus Therapeutics, Inc. will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025 [1] - The presentation is scheduled for September 8, 2025, at 3:30 PM ET, and will be accessible via a live webcast [2] Company Overview - Indaptus Therapeutics focuses on immunotherapy, utilizing a multi-targeted approach to activate both innate and adaptive immune responses [3] - The company's patented technology involves non-pathogenic Gram-negative bacteria that produce multiple immune system-activating signals, designed for safe intravenous administration [3] - Decoy product candidates have shown efficacy against various cancers and chronic viral infections in pre-clinical models, demonstrating significant single-agent activity [3] - The Decoy platform has been effective in combination with other therapies, leading to tumor eradication and the induction of immunological memory [3] - IND-enabling studies indicate that intravenous administration of Decoy product candidates does not induce significant cytokine release syndromes, suggesting a favorable safety profile [3]

As filed with the Securities and Exchange Commission on September 2, 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 INDAPTUS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-3158720 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 3 Columbus Ci ...

Core Insights - Pelareorep demonstrates a favorable safety profile across multiple indications and treatment combinations, with over 1,200 patients dosed, including more than 300 gastrointestinal cancer patients [1][3] - The most common adverse events associated with pelareorep are Grade 1 and 2 symptoms such as fever, chills, fatigue, nausea, vomiting, and diarrhea, with no significant modification of Grade 3 or 4 adverse events from chemotherapy when combined with pelareorep [2][3] - Oncolytics Biotech is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors for metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA [5] Company Overview - Oncolytics Biotech Inc. is a clinical-stage biotechnology company focused on developing pelareorep, an intravenously delivered double-stranded RNA immunotherapeutic agent [4] - Pelareorep has shown promising results in various cancer studies, including first-line pancreatic cancer, metastatic breast cancer, and early-phase studies in anal and colorectal cancer [4] - The company is actively pursuing strategic partnerships to enhance development and commercial impact [5]

Core Insights - Akeso has completed patient enrollment in a Phase III study for ivonescimab, targeting advanced biliary tract cancer, comparing it with durvalumab combination therapy [1] - Ivonescimab has shown significant positive results in previous Phase III studies, leading to its approval for PD-L1-positive non-small cell lung cancer [2][3] - The drug targets both PD-1 and VEGF, providing a synergistic anti-tumor effect, establishing it as a leader in immunotherapy [4] Company Overview - Akeso is a biopharmaceutical company focused on innovative biological medicines, with a robust pipeline of over 50 assets in various disease areas [10] - The company utilizes a unique integrated R&D innovation system and has developed a GMP-compliant manufacturing system [10] - Akeso aims to provide affordable therapeutic antibodies globally while creating commercial and social value [10] Development Strategy - Akeso is implementing a dual-path strategy to maximize ivonescimab's value, focusing on domestic commercialization in China and global development partnerships [5] - The company has an extensive clinical foundation with over 20 Phase II studies across more than 10 tumor types, facilitating rapid transition to registrational studies [3]

Core Viewpoint - OSE Immunotherapeutics is reaffirming its strategic priorities and addressing shareholder concerns ahead of its Annual General Meeting (AGM) scheduled for September 30, 2025, amidst shareholder activism and misinformation campaigns [1][3][4] Company Strategy - The company aims to leverage its two main programs, Tedopi® and Lusvertikimab, through strategic partnerships and financing, positioning itself as a leading European biotech in immunotherapy for oncology and inflammation [2][5] - OSE's strategy focuses on maintaining strategic optionality for its lead assets while balancing near-term financing and value creation to avoid premature dilution of shareholder value [5][6] Shareholder Activism - OSE has faced significant shareholder activism, including a misinformation campaign by minority shareholders, which has created confusion ahead of the AGM [3][8] - The company has initiated legal actions to protect all shareholders and ensure a fair debate, as the activist group has allegedly acted against sound governance principles [8][10] AGM and Legal Proceedings - The AGM has been postponed to September 30, 2025, to ensure fair voting conditions based on accurate information regarding the intentions of the activist shareholders [9][11] - Legal proceedings have been initiated to investigate the actions of minority shareholders, with potential implications for their voting rights if irregularities are confirmed [10][11] Financial and Development Plans - Tedopi® is in a pivotal Phase 3 clinical trial for non-small cell lung cancer, with enrollment completion expected in the second half of 2026 and initial readouts anticipated by the end of 2027 [14] - Lusvertikimab's development includes a Phase 2b trial in ulcerative colitis, expected to start in 2026, with readouts in 2027 and 2028 [14] - The company has clarified that the expected cost for the Lusvertikimab trial is in the tens of millions of euros, significantly lower than misleading figures circulated by activist shareholders [14] Governance and Communication - OSE emphasizes its commitment to transparent governance and has published a Shareholder Q&A to counter misinformation and provide clear information on its strategy and financial trajectory [7][12] - The company is dedicated to maintaining open dialogue with shareholders and encourages them to review the Q&A document for accurate information [13]

Core Points - Quest PharmaTech Inc. held its annual general meeting on August 25, 2025, where four directors were re-elected to the Board of Directors [1] - The company reported that approximately 50,288,000 shares were voted, representing about 29.7% of the eligible shares [2] - Quest granted 1,900,000 stock options to Directors and Officers at an exercise price of $0.05 per share, expiring in 10 years, pending TSX Venture Exchange approval [3] Company Overview - Quest PharmaTech Inc. is a Canadian biopharmaceutical company focused on developing products to enhance quality of life through proprietary technologies and investee companies [4] - The company is developing MAb-AR9.6, a theranostic agent targeting MUC16 for cancer, which is currently in late preclinical stage development [4] - Quest holds a 42.5% interest in OncoQuest Inc., which sold its immunotherapy technology assets in April 2020, and a 23% interest in OncoVent, a joint venture in China focused on antibody-based immunotherapeutic products for cancer [4]

Core Insights - BriaCell Therapeutics Corp. has published research on the mechanism of action of its next-generation personalized off-the-shelf immunotherapy, Bria-OTS+, in collaboration with the National Cancer Institute (NCI) [1][2] - The study highlights that semi-allogeneic dendritic-cell vaccines enhance anti-tumor effects by recruiting alloreactive CD4⁺ T-cells, which strengthens CD8⁺ T-cell responses against tumors [2] - The findings validate the design principle of Bria-OTS+, emphasizing the importance of partial HLA matching for effective tumor-antigen presentation and robust CD4⁺ helper responses [2] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [5] - The lead candidate, Bria-IMT, is currently being evaluated in a Phase 1/2a study for patients with metastatic recurrent breast cancer, which includes both monotherapy and combination therapy cohorts [4] Research and Development - The publication in JCI Insight provides insights into the mechanism of action of Bria-OTS+, aligning with the encouraging clinical results reported in the Phase 1/2a study for metastatic breast cancer [2][4] - Bria-OTS+ is characterized as a novel personalized, off-the-shelf, semi-allogeneic cellular immunotherapy that may address urgent unmet medical needs for cancer patients [7]

Core Insights - BriaCell Therapeutics Corp. has published research on the mechanism of action of its next-generation personalized off-the-shelf immunotherapy, Bria-OTS+, in collaboration with the National Cancer Institute (NCI) [1][2][7] - The study highlights the anti-tumor effects of Bria-OTS+, demonstrating that semi-allogeneic dendritic-cell vaccines enhance CD4⁺ T-cell help and strengthen CD8⁺ T-cell responses against tumors [2][7] - The findings validate the design principle of Bria-OTS+, emphasizing the importance of partial HLA matching for effective tumor-antigen presentation and robust CD4⁺ helper responses [2][7] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [5] - The lead candidate, Bria-IMT, is currently being evaluated in a Phase 1/2a study for patients with metastatic recurrent breast cancer, which includes both monotherapy and combination therapy cohorts [4] Research Publication - The publication titled "Enhancing dendritic cell cancer vaccine by allogeneic MHC class II expression and Treg depletion" has been featured in JCI Insight, a peer-reviewed journal [2] - The research provides insights into the cellular immunotherapy platform technology of BriaCell, aligning with the encouraging clinical results reported in recent studies [2]

Core Insights - PDS Biotechnology Corporation announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial, showing a median overall survival (mOS) of 39.3 months in patients with CPS ≥ 1, significantly outperforming the best published result of 17.9 months with standard care pembrolizumab or pembrolizumab + chemotherapy [1][2][7] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune system responses to cancer, particularly through its lead investigational product PDS0101 (Versamune HPV) [5] - The company is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers, with ongoing pivotal clinical trials [5] Clinical Trial Details - The VERSATILE-002 trial is an open-label, multi-center Phase 2 study evaluating the safety and efficacy of PDS0101 in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive head and neck squamous cell cancer [4] - The trial enrolled 53 patients, with PDS0101 administered via subcutaneous injection alongside IV infusion of pembrolizumab during the first four treatment cycles [7] Survival Data and Efficacy - The mOS of 39.3 months was achieved in patients with CPS ≥ 1, with a 95% confidence interval lower limit of 23.9 months [7] - The durable patient survival is attributed to high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101, consistent across various patient demographics and clinical characteristics [7] Market Position and Future Outlook - PDS Biotech is positioned for leadership in the rapidly growing segment of HPV16-positive head and neck cancer, addressing a significant unmet medical need [3] - The combination therapy of PDS0101 and pembrolizumab is reported to be well tolerated, with no patients discontinuing due to treatment-related adverse events [3]

Core Insights - HCW Biologics has developed a second-generation, pembrolizumab-based immune checkpoint inhibitor that shows promise against solid tumors, particularly pancreatic and ovarian cancer, utilizing its proprietary TRBC product discovery platform [1][3][4] - Immune checkpoint inhibitors (ICIs) have been recognized as a breakthrough in cancer therapy since 2011, but their efficacy is limited, with less than 20% of patients responding durably to treatment [2][3] - The new pembrolizumab-based fusion molecules aim to enhance the immune response by neutralizing immunosuppressive cytokines and promoting immune cell infiltration into tumors, potentially outperforming existing therapies [3][4] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies to combat diseases linked to chronic inflammation, particularly age-related conditions [7] - The company has created over 50 molecules using its TRBC platform, which allows for the construction of various classes of immunotherapeutic compounds targeting cancer and other diseases [7] - The lead product candidate, HCW9302, was developed using the legacy TOBI platform, while the TRBC platform represents a new approach to immunotherapy [7] Market Context - Immune checkpoint inhibitors generated over $40 billion in global sales in 2024, indicating a significant market presence despite their limited efficacy [3] - The ongoing research into second-generation ICIs reflects a broader trend in the industry to improve treatment outcomes for patients with difficult-to-treat solid tumors [4][5]