GAITHERSBURG, Md., May 15, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update. Shuttle Pharma’s recent highlights: Phase 2 clinical trial of Ropidoxuridine for treatment of patients with glioblastoma highlights include: Patient enrollment nears milestone as n ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission File Number 001-41488 SHUTTLE PHARMACEUTICALS HOLDINGS, INC. (Exact name of registrant as specified in its charter ...

GAITHERSBURG, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today that it has nearly achieved 50% enrollment in the initial randomized portion of its Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma, with treatment sites repo ...

Core Viewpoint - Shuttle Pharmaceuticals Holdings, Inc. has filed a provisional patent application for "PSMA-Targeted PARP Inhibitor Conjugates for Precision Cancer Therapy," which is a significant step in advancing its diagnostic and therapeutic programs for prostate cancer [1][7]. Company Overview - Shuttle Pharmaceuticals is a discovery and development stage specialty pharmaceutical company founded in 2012, focused on improving outcomes for cancer patients treated with radiation therapy [8]. - The company aims to develop therapies that maximize the effectiveness of radiation therapy while minimizing side effects, thereby improving cancer cure rates and patient quality of life [8]. Research and Development - The provisional patent application is part of the company's efforts to create highly specific and effective theranostic agents for metastatic castration-resistant prostate cancer, utilizing PSMA ligands for accurate imaging and targeted therapy delivery [1][7]. - The collaboration with Dr. Alan Kozikowski, a pioneer in PSMA targeting, has been instrumental in the development of these therapeutic agents [2][5]. Market Potential - The global PSMA PET imaging market was valued at $1.5 billion in 2022 and is projected to reach $2.0 billion by 2030, indicating significant growth potential in this area [7]. - The targeted radiopharmaceutical treatment Pluvitco® for PSMA-positive metastatic prostate cancer is expected to have a market size of $2 billion [7]. Diagnostic Initiatives - Shuttle Diagnostics, a subsidiary of Shuttle Pharmaceuticals, is focused on developing pretreatment diagnostic blood tests for prostate cancer patients, including the PSMA-B ligand and the PC-Rad test [4]. - Currently, there are no available tests on the market that can predict treatment success for prostate cancer specifically [4]. Scientific Collaboration - The company has collaborated with Dr. Kozikowski and other researchers to discover novel PSMA ligands aimed at enhancing the targeting of prostate cancer cells [5][6]. - The research into antibody-drug conjugates (ADCs) and the advantages of smaller PSMA targeting ligands for drug delivery is a promising area of exploration [3].

GAITHERSBURG, Md., March 13, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today the closing of its previously announced underwritten public offering of 19,166,667 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) at a public offering price of $0.30 pe ...

GAITHERSBURG, Md., March 12, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today the pricing of an underwritten public offering of 19,166,667 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) at a public offering price of $0.30 per share (the “Offering ...

GAITHERSBURG, Md., March 12, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today announced the appointment of Christopher Cooper as interim Co-Chief Executive Officer focused on enhancing the Company’s capital markets and business capabilities. Dr. Anatoly Dritschilo, Chairman of the Com ...

Company Filings - Shuttle Pharmaceuticals Holdings, Inc. filed its Annual Report on Form 10-K for the year ended December 31, 2024, on February 26, 2025[5] - The press release dated February 26, 2025, provides a corporate update, although specific financial metrics are not detailed in the provided content[5] Company Classification - The company is classified as an emerging growth company under the Securities Act of 1933[4]

Core Insights - Shuttle Pharmaceuticals Holdings, Inc. is focused on improving outcomes for cancer patients treated with radiation therapy, with significant developments in their clinical trials and diagnostics [1][2][3] Group 1: Clinical Developments - The company has commenced a Phase 2 clinical trial of Ropidoxuridine for glioblastoma, with over one-third of the initial randomized enrollment completed [2][4] - As of the latest update, 16 out of 40 patients have been enrolled in the trial, with 8 patients completing all seven cycles [4] Group 2: Diagnostic Advancements - Shuttle Diagnostics, a subsidiary of the company, is advancing its diagnostic capabilities, including a PC-Rad test for localized prostate cancer and a PSMA-B ligand for metastatic prostate cancer [2][4] - A sponsored research agreement with the University of California, San Francisco (UCSF) has been established to further develop a theranostic molecule targeting prostate-specific membrane antigen (PSMA) [4] Group 3: Corporate Developments - The company has launched a new corporate website to highlight its dual approach to cancer therapeutics and diagnostics [4] - Significant investments have been made into the business, including a recent financing transaction where the CEO contributed $237,500 [4]

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].