As filed with the Securities and Exchange Commission on September 20, 2024 Registration No. 333-281834 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 IMUNON, INC. (Exact name of registrant as specified in its charter) DELAWARE 52-1256615 (State or other jurisdiction of incorporation or organization) 997 Lenox Drive, Suite 100 Lawrenceville, New Jersey 08648 (609) 896-9100 (Address, including zip code ...

Incyte (INCY) Update Summary Company Overview - **Company**: Incyte Corporation - **Event**: Investor Event at ESMO 2024 - **Date**: September 14, 2024 Key Points Industry and Company Focus - Incyte is focusing on oncology, specifically targeting gynecological cancers and squamous cell anal cancer with their drug candidates, including retifanlimab and a new CDK2 inhibitor [2][3][4][5][6][9][31][41]. Core Programs and Data Updates - **Retifanlimab**: - Positive pivotal data presented for squamous cell anal cancer, showing a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for placebo, with a hazard ratio of 0.63 [24][30]. - The study design included a combination of retifanlimab with chemotherapy for patients with advanced disease [21][22]. - **CDK2 Inhibitor**: - Focused on ovarian and endometrial cancers, with plans to initiate pivotal trials in 2025 [10][43][60]. - The drug targets cyclin E overexpression, which is prevalent in HRD negative ovarian cancer patients [35][44][63]. - Early data shows a response rate of 31% in heavily pretreated ovarian cancer patients, with a disease control rate of 75% [56][60]. Pipeline and Milestones - Incyte has several near-term milestones, including: - Approval of axatilamab for chronic graft versus host disease [5][71]. - Submission for pediatric atopic dermatitis for OPSILURA [71]. - Potential approval of retifanlimab in new indications, including anal cancer and non-small cell lung cancer [71][72]. - Ongoing discussions for regulatory strategies for the CDK2 inhibitor in platinum-resistant ovarian cancer [66][69]. Market Dynamics and Competitive Landscape - The incidence of anal cancer is increasing by approximately 3% annually, largely due to HPV [14][15]. - Current treatment options for advanced anal cancer are limited, with chemotherapy being the standard of care [18][19]. - In ovarian cancer, there is a significant unmet need for effective treatments, especially in HRD negative patients, where current therapies have limited efficacy [32][34][63]. Safety and Efficacy - Safety data from the CDK2 inhibitor trials indicate manageable adverse events, primarily hematological toxicities, with few discontinuations due to treatment-related issues [50][51]. - The combination of retifanlimab with chemotherapy has shown promising results without compromising the delivery of chemotherapy [30][60]. Future Directions - Incyte aims to position the CDK2 inhibitor as a new standard of care in ovarian cancer, particularly in combination with existing therapies like bevacizumab [38][41][60]. - The company is also exploring the potential of retifanlimab in other cancer types and is preparing for commercial launches in 2025 [71][80]. Additional Insights - The company is leveraging its existing infrastructure from previous drug launches to facilitate the introduction of new therapies [78][80]. - There is a focus on developing companion diagnostics to identify patients who would benefit most from the CDK2 inhibitor [84][86]. This summary encapsulates the critical insights and developments from Incyte's recent investor event, highlighting the company's strategic focus on oncology and the promising data emerging from its clinical trials.

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) As filed with the Securities and Exchange Commission on September 12, 2024 Copies of all communications, including communications sent to agent for service, should be sent to: Peter N. Handrinos, Esq. Latham & Watkins LLP John Hancock Tower 200 Clarendon Street Boston, ...

As filed with the Securities and Exchange Commission on September 6, 2024 Registration No. 333- 1900 Lake Park Drive, Suite 380, Smyrna, Georgia 30080 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) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 87-0455038 (I.R.S ...

As filed with the Securities and Exchange Commission on September 6, 2024 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) (State or other jurisdiction of incorporation or organization) Delaware 2834 87-0455038 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 1900 Lake Park Drive, ...

As filed with the Securities and Exchange Commission on August 29, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 IMUNON, INC. (Exact name of registrant as specified in its charter) (I.R.S. Employer Identification No.) 997 Lenox Drive, Suite 100 Lawrenceville, New Jersey 08648 (609) 896-9100 (Address, including zip code, and telephone number, including area code, of Registrant's principal exe ...

As filed with the Securities and Exchange Commission on August 6, 2024 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) (State or other jurisdiction of incorporation or organization) Delaware 2834 87-0455038 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 1900 Lake Park Drive, Su ...

As filed with the Securities and Exchange Commission on June 27, 2024 Registration No. 333-279156 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2836 81-4182129 (I.R.S. Employer Identifi ...

As filed with the Securities and Exchange Commission on June 21, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Tevogen Bio Holdings Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 98-1597194 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 15 Independence Boul ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on June 14, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 3841 | 85-3009869 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Cl ...