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].

Core Insights - Shuttle Pharmaceuticals Holdings, Inc. has achieved 25% enrollment in the initial randomized portion of its Phase 2 Clinical Trial for Ropidoxuridine, targeting glioblastoma patients [1][2] - The trial aims to identify an optimal dose of Ropidoxuridine by randomizing 40 patients into two groups, with the goal of demonstrating improved survival compared to historical controls [2][3] - Ropidoxuridine is positioned as a radiation sensitizer to enhance the effectiveness of radiation therapy for glioblastoma, a highly aggressive brain tumor with no known cure [3] Company Overview - Founded in 2012, Shuttle Pharmaceuticals focuses on developing therapies to improve outcomes for cancer patients undergoing radiation therapy [7] - The company aims to increase cancer cure rates, prolong survival, and enhance quality of life through the development of radiation sensitizers [7] Market Opportunity - Approximately 800,000 patients in the US receive radiation therapy annually, with about 50% treated for curative purposes, representing a significant market for radiation sensitizers [5] - The number of patients treated for curative purposes is expected to grow by more than 22% over the next five years, indicating a robust market opportunity for Shuttle Pharmaceuticals [5]

Core Viewpoint - Shuttle Pharmaceuticals Holdings, Inc. is focused on improving outcomes for cancer patients undergoing radiation therapy and will discuss its future plans and clinical trials in an upcoming investor summit [1][3]. Company Overview - Shuttle Pharmaceuticals, founded in 2012 by faculty members of Georgetown University Medical Center, is a specialty pharmaceutical company dedicated to enhancing cancer treatment outcomes through radiation therapy [4]. - The company's mission is to develop therapies that maximize the effectiveness of radiation therapy while minimizing side effects, aiming to increase cancer cure rates and improve patient quality of life [4]. Upcoming Events - CEO Anatoly Dritschilo will participate in a webcasted fireside chat at the Lytham Partners 2025 Investor Healthcare Summit on January 13, 2025, at 3:30 p.m. Eastern time [2][3]. - The webcast will be accessible online, and a replay will be available after the event [2]. Clinical Trials and Developments - Dr. Dritschilo will discuss the progress of the Phase 2 Clinical Trial of Ropidoxuridine for glioblastoma treatment, currently enrolling patients at six cancer centers [3]. - The trial targets patients with IDH wild-type, methylation negative glioblastoma [3]. - Recent developments in Shuttle Diagnostics, particularly the PC-RAD test for predicting outcomes after radiation therapy for localized prostate cancer, will also be addressed [3].

Core Viewpoint - Shuttle Pharmaceuticals Holdings, Inc. has entered into a research agreement with UCSF to advance the pre-clinical development of a novel PSMA ligand for prostate cancer diagnosis and therapy, highlighting the potential of theranostic molecules in improving cancer treatment outcomes [1][2]. Company Overview - Shuttle Pharmaceuticals is a specialty pharmaceutical company founded in 2012, focused on enhancing outcomes for cancer patients undergoing radiation therapy by developing therapies that maximize effectiveness while minimizing side effects [5]. Research Agreement Details - The agreement with UCSF aims to develop a boron-containing PSMA ligand, PSMA-B, which has shown nanomolar binding activity to PSMA and is being evaluated for its potential as a sensitizer in proton therapy for prostate cancer [2]. - UCSF researchers will work on producing a specific probe and investigating its binding properties and diagnostic potential across various prostate cancer phenotypes [2]. Market Opportunity - There is a significant market opportunity for PSMA ligands in prostate cancer diagnosis and treatment, particularly for metastatic castration-resistant prostate cancer, with the global PSMA PET imaging market projected to grow from $1.5 billion in 2022 to $2.0 billion by 2030 [3]. - The targeted radiopharmaceutical treatment Pluvicto® for PSMA-positive metastatic prostate cancer is expected to reach a market size of $2 billion [3]. Future Outlook - The collaboration with UCSF is expected to advance the development of the PSMA-B ligand, which could play a crucial role in the future of prostate cancer diagnosis and treatment [4].

Core Viewpoint - Shuttle Pharmaceuticals is advancing its Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment, with the first patient enrolled at UVA Cancer Center, aiming to improve outcomes for cancer patients undergoing radiation therapy [1][5]. Company Overview - Shuttle Pharmaceuticals is a discovery and development stage specialty pharmaceutical company founded in 2012, focused on enhancing cancer treatment outcomes through radiation sensitizers [7]. - The company's mission is to improve the lives of cancer patients by maximizing the effectiveness of radiation therapy while minimizing side effects [7]. Clinical Trial Details - The Phase 2 trial will initially involve 40 patients randomized into two dosing groups (20 patients at 1,200 mg/day and 20 patients at 960 mg/day) to identify the optimal dose [2]. - Following the determination of the optimal dose, an additional 14 patients will be added to achieve statistical significance, with survival as the primary endpoint compared to historical controls [2]. - The trial targets patients with IDH wild-type, methylation negative glioblastoma, a type of brain tumor with a poor prognosis, where standard care is currently limited to radiation therapy [2]. Market Opportunity - Approximately 800,000 patients in the US receive radiation therapy for cancer annually, with about 50% treated for curative purposes, representing a significant market opportunity for radiation sensitizers [5]. - The number of patients treated for curative purposes is expected to grow by more than 22% over the next five years, indicating a rising demand for effective treatments [5]. Regulatory Status - Ropidoxuridine has received Orphan Drug Designation from the FDA, which may provide marketing exclusivity upon first approval for glioblastoma treatment [3]. Trial Locations - The Phase 2 trial is being conducted at multiple prestigious cancer centers, including UVA Cancer Center, Georgetown University Medical Center, and Miami Cancer Institute, among others [4].

Corporate Update - Shuttle Pharmaceuticals Holdings, Inc. issued a corporate update on November 13, 2024, in connection with its Quarterly Report for the period ended September 30, 2024[2]. - The press release detailing the financial results is attached as Exhibit 99.1[3]. - The report was signed by CEO Anatoly Dritschilo, indicating leadership's involvement in the financial disclosure[6]. Company Classification - The company is classified as an emerging growth company under the Securities Act of 1933[2]. Financial Performance - The report does not include specific financial performance metrics or user data in the provided content[2][4]. - The company has not provided future outlook or performance guidance in the disclosed content[2][4]. Product and Market Strategy - The company has not indicated any new product launches or technological developments in the available information[2][4]. - There is no mention of market expansion or acquisition strategies in the current report[2][4]. Legal and Filing Status - The filing is not considered "filed" for purposes of the Exchange Act, limiting its legal implications[4]. - The report includes an Interactive Data File as part of its exhibits[5].