Drug Development and Clinical Trials - The company is developing Ropidoxuridine, a Phase II clinical-stage radiation sensitizer, and has established a maximum tolerated dose (MTD) of 1,200 mg/day in combination with radiation therapy[26]. - In December 2023, the company submitted an Investigational New Drug (IND) application to the FDA for Ropidoxuridine, receiving a 'Safe to Proceed' letter in January 2024, allowing the commencement of the Phase II study[16]. - The Phase II clinical trial will involve an initial cohort of 40 patients, randomized to receive either 1,200 mg or 960 mg doses of Ropidoxuridine, with the optimum dose determined by comparing drug bioavailability and side effects[28]. - The clinical development of Ropidoxuridine has shown oral bioavailability and a maximum tolerated dose established for use in Phase II clinical trials, with 17 patients enrolled as of February 2025[26]. - The company aims to complete Phase II clinical trials to present data to the FDA for efficacy determination, which will support efforts to raise additional capital for further trials[49]. - Shuttle Pharma has received FDA orphan drug status for Ropidoxuridine as a clinical radiation sensitizer for glioblastoma, with plans for Phase II efficacy trials in brain tumors, soft tissue sarcomas, and rectal cancers[48]. - The company has received FDA approval for Orphan designation for Ropidoxuridine and radiation therapy for treating glioblastoma[16]. - The company plans to commercialize Ropidoxuridine and HDAC6 inhibitor (SP-2-225) if approved by the FDA, focusing on reducing health disparities in prostate cancer treatment[33]. - The company has completed three SBIR contracts with the NIH to support the development of Ropidoxuridine and other products, including a predictive biomarker test for radiation response[30]. - The HDAC platform technology is being utilized to develop drugs for cancer radiation sensitization, normal tissue radiation protection, and post-radiation immune stimulation[34]. Financial Performance and Capital Needs - The Company reported a net loss of approximately $9.1 million and no revenues for the year ended December 31, 2024, with working capital of approximately $0.7 million[107]. - The Company has incurred significant losses since its inception, with an accumulated deficit of $34.6 million as of December 31, 2024[114]. - The Company completed an equity raise in October 2024, providing $4.0 million in cash, net of placement agent fees, and received $790 thousand from senior secured convertible bridge notes[109]. - The company anticipates needing substantial additional financing to obtain marketing approval and commercialize product candidates, with a potential requirement for additional capital within one year[120]. - The company is reliant on raising additional equity or debt financing to fund its operations and continue as a going concern[106]. - The company currently has no source of product sales revenue and does not anticipate generating revenue from product sales for the foreseeable future[115]. - The company has invested $3,618,796 and $3,517,093 in research and development expenses for the fiscal years ended December 31, 2024 and 2023 respectively[85]. - The company plans to apply for Phase IIb SBIR funding to support the clinical validation trial for a metabolite predictive biomarker panel[83]. Market and Competitive Landscape - The U.S. market for radiation sensitizing agents is experiencing growth, driven by new technologies and an increase in diagnosed cancer patients, with approximately 67% of 1.25 million cancer patients treated with radiation therapy annually[38]. - The company faces intense competition from multinational pharmaceutical companies and specialized biotechnology firms, which may affect its ability to develop and commercialize product candidates[134]. - Competitors may have greater financial and technical resources, which could impact the company's market position and ability to recover development costs[135]. - Market acceptance of product candidates will depend on various factors, including regulatory approvals, safety and efficacy, and reimbursement from third-party payors[121]. Regulatory and Compliance Issues - The company is currently not in compliance with Nasdaq's minimum stockholders' equity requirement of $2.5 million and has until March 10, 2025, to regain compliance[99]. - The Company received a letter from Nasdaq stating it failed to maintain a minimum closing bid price of $1.00 per share, with a compliance period until June 30, 2025[100]. - The company has filed for a reverse stock split to regain compliance with Nasdaq's Minimum Bid Price Requirement[101]. - The company is subject to extensive laws and regulations in the healthcare industry, which may restrict various business arrangements and expose it to liability if noncompliance occurs[142]. - Non-compliance with regulatory requirements could lead to penalties, including withdrawal of marketing approvals, which would adversely affect the company's business[139]. Intellectual Property and Research - The company has filed six patent applications with the U.S. Patent and Trademark Office (USPTO) related to its HDAC inhibitor small molecule delivery platforms and its lead product candidate, Ropidoxuridine[150]. - The company has 20 granted patents, including five core patents from the USPTO related to their HDAC small molecule delivery platform[87]. - The company may face challenges in protecting its trade secrets, which are crucial for maintaining its competitive position[165]. - The company may face costly and time-consuming litigation related to patent infringement claims, which could delay product development and commercialization[158]. Operational Risks - The company has no owned manufacturing facilities and relies on third-party manufacturers for GMP synthesis and drug formulation[62]. - The company relies on third-party collaborators for conducting clinical trials, which may lead to delays or adverse effects on business if these parties do not perform as required[128]. - The manufacturing process is subject to FDA and foreign regulatory authority review, and any failure to comply could negatively impact product development timelines[131]. - The company is dependent on key management and technical personnel, and the loss of such individuals could materially harm its business and operations[136]. Future Outlook and Strategic Plans - The company intends to raise capital through the public market for predictive biomarker development via the Shuttle Diagnostics entity[83]. - The company plans to engage in collaborations to maximize the applications of its HDAC technology platform for cancer treatment[34]. - The company has established strategic agreements with institutions like Georgetown University for access to intellectual property and research collaboration[63]. - The company’s ability to achieve profitability is contingent upon obtaining regulatory approvals and successfully commercializing product candidates[125].
Shuttle Pharmaceuticals (SHPH) - 2024 Q4 - Annual Report