Core Insights - Shuttle Pharmaceuticals is focused on improving outcomes for cancer patients treated with radiation therapy, with significant progress in its Phase 2 clinical trial for Ropidoxuridine in glioblastoma treatment [1][2] - The company is also advancing its Diagnostics subsidiary through a research agreement with UCSF and has filed a provisional patent for PSMA-targeted therapies [1][2] Phase 2 Clinical Trial Highlights - Nearly 50% of patient enrollment achieved in the initial randomized portion of the trial [2] - 84% of enrolled patients completed all seven cycles of treatment [2] - Ropidoxuridine has been well-tolerated, with reported toxicity no greater than 2 on a scale of 1-5 [2] - Analysis of pharmacokinetic and pharmacodynamic samples has begun to optimize dosing and response [2] - Enrollment continues at recognized cancer centers, with the objective to finalize enrollment later this year and data readouts anticipated in 2026 [2] Diagnostics Subsidiary Developments - A sponsored research agreement with UCSF aims to develop a PSMA-targeted ligand for theranostic applications in prostate cancer [1][2] - A provisional patent application for "PSMA-Targeted PARP Inhibitor Conjugates for Precision Cancer Therapy" has been filed in collaboration with Dr. Alan Kozikowski [1][2] Corporate Governance and Financial Position - Three new board members have been appointed to enhance the company's strategic direction [1][2] - The company has strengthened its balance sheet through a recent public offering, with cash and cash equivalents reported at $4.5 million as of March 31, 2025 [2]

Part I [Item 1. Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Unaudited Q1 2025 financials show no revenue, a widening net loss, and significant cash burn, despite a **$5.0 million** equity raise strengthening the balance sheet, with substantial going concern risk [Unaudited Condensed Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) Total assets grew to **$5.31 million** by March 31, 2025, driven by a **$4.51 million** cash increase from financing, turning stockholders' equity positive to **$3.29 million** from a **$0.71 million** deficit Condensed Consolidated Balance Sheet Data (Unaudited) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $4,959,397 | $2,210,917 | | **Total Assets** | $5,310,190 | $2,506,290 | | **Total Current Liabilities** | $1,782,177 | $1,533,769 | | **Total Liabilities** | $2,024,925 | $1,797,138 | | **Total Stockholders' Equity** | $3,285,265 | $709,152 | - Cash and cash equivalents increased significantly to **$4,512,607** from **$1,920,144** at the end of the previous year[9](index=9&type=chunk) [Unaudited Condensed Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2025 saw no revenue, with net loss widening to **$3.05 million** from **$1.73 million**, primarily due to a significant increase in R&D expenses to **$1.57 million** Statement of Operations Summary (Three Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Revenue | $0 | $0 | | Research and Development | $1,573,928 | $586,104 | | Total Operating Expenses | $2,951,241 | $1,384,847 | | **Net Loss** | **($3,053,007)** | **($1,731,031)** | | Net Loss Per Share | ($0.30) | ($0.83) | [Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity increased to **$3.29 million**, primarily driven by a **$5.0 million** capital raise from common stock and pre-funded warrants, partially offset by the **$3.05 million** net loss - The issuance of common stock and pre-funded warrants, net of issuance costs, added **$5,038,574** to stockholders' equity[15](index=15&type=chunk) - The net loss for the quarter of **$3,053,007** was the primary reduction to stockholders' equity[15](index=15&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 cash and cash equivalents increased by **$2.59 million**, driven by **$5.12 million** from financing activities, offsetting **$2.53 million** used in operations Cash Flow Summary (Three Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,526,924) | ($1,239,083) | | Net cash provided by investing activities | $0 | $101,295 | | Net cash provided by (used in) financing activities | $5,119,387 | ($40,000) | | **Net change in cash and cash equivalents** | **$2,592,463** | **($1,177,788)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight substantial 'going concern' risk due to recurring losses and insufficient cash, despite a **$5.0 million** March 2025 equity raise, with significant future commitments including **$5.3 million** for clinical trials and a **$2.0 million** marketing payment - The company's financial statements are prepared on a going concern basis, but management has identified conditions that raise substantial doubt about its ability to continue as a going concern within one year[24](index=24&type=chunk)[26](index=26&type=chunk) - In March 2025, the company completed a public offering of common stock and pre-funded warrants, resulting in net proceeds of approximately **$5.0 million**[88](index=88&type=chunk)[89](index=89&type=chunk) - The company has significant commitments, including an agreement with its primary CRO for clinical trials with a total cost limit of **$5.3 million**, and a subsequent event in April 2025 where it paid **$2.0 million** for a three-month marketing agreement[114](index=114&type=chunk)[119](index=119&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's development-stage status, Phase II clinical study, Nasdaq non-compliance, and a **76%** increase in net loss driven by **169%** higher R&D expenses, reiterating substantial going concern doubt despite recent financing - The company is a discovery and development stage pharmaceutical firm whose Phase II clinical study for Ropidoxuridine commenced in October 2024[125](index=125&type=chunk)[126](index=126&type=chunk) - The company is not in compliance with Nasdaq's **$1.00** minimum bid price requirement and faces potential delisting if compliance is not regained by June 30, 2025[127](index=127&type=chunk)[128](index=128&type=chunk) - Management concludes there is substantial doubt about the company's ability to continue as a going concern as existing cash resources are not expected to be sufficient to fund operations for the next twelve months[144](index=144&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Q1 2025 net loss increased **76%** to **$3.05 million**, primarily driven by a **169%** rise in Research and Development expenses due to clinical trial initiation Comparison of Operations (Three Months Ended March 31) | Metric | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $1,573,928 | $586,104 | 169% | | General and administrative | $596,886 | $324,609 | 84% | | Legal and professional | $780,427 | $474,134 | 65% | | **Net loss** | **($3,053,007)** | **($1,731,031)** | **76%** | - The **$1.0 million** increase in R&D expense is primarily related to the start of work on clinical trials, including CRO expenses and other regulatory activities[134](index=134&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) Working capital improved to **$3.2 million** due to a **$5.0 million** equity raise, but significant commitments, including a **$2.0 million** marketing payment, mean funds are insufficient for the next 12 months, reiterating going concern risk - Working capital increased by **$2.5 million** to **$3.2 million** as of March 31, 2025, primarily due to the March 2025 equity raise[147](index=147&type=chunk) - In February 2025, the company secured a **$2.0 million** revolving loan facility, which remained undrawn as of the report date[145](index=145&type=chunk) - Subsequent to the quarter end, on April 5, 2025, the company paid **$2.0 million** for a three-month marketing and advertising services agreement[143](index=143&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Critical accounting policies involve significant judgments and estimates, particularly for R&D expenses and fair value measurement of complex financial instruments using Monte Carlo simulations with subjective inputs - The most critical accounting policies are identified as Research and Development Expenses, Fair Value of Convertible Notes, and Fair Value of Warrants and Derivative Financial Instruments[163](index=163&type=chunk) - The valuation of convertible notes and certain warrants utilizes Monte Carlo simulation models, which depend on significant unobservable inputs and management judgment, making them subject to material changes[158](index=158&type=chunk)[164](index=164&type=chunk)[167](index=167&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a 'smaller reporting company,' the company is exempt from providing disclosures on quantitative and qualitative market risk - As a 'smaller reporting company,' the company is exempt from the disclosure requirements of this Item[169](index=169&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were ineffective as of March 31, 2025, due to material weaknesses including inadequate policies, lack of segregation of duties, and IT control deficiencies, despite remediating prior issues - Management concluded that disclosure controls and procedures were ineffective as of March 31, 2025[171](index=171&type=chunk) - Identified material weaknesses include limited written policies, lack of segregation of duties, improper R&D expense classification, and issues with IT general controls[171](index=171&type=chunk)[175](index=175&type=chunk) - The company successfully remediated previously disclosed material weaknesses related to the accounting for significant unusual transactions (debt/equity) and stock-based compensation as of March 31, 2025[173](index=173&type=chunk) Part II. Other Information [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending or threatened legal proceedings that would materially adversely affect its business - There are no legal proceedings pending or threatened against the company[177](index=177&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) As a 'smaller reporting company,' the company is exempt from providing risk factor disclosures - The company is exempt from this disclosure requirement due to its status as a 'smaller reporting company'[178](index=178&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds occurred during the reported period - No unregistered sales of securities occurred during the quarter[179](index=179&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - No directors or executive officers adopted or terminated a Rule 10b5-1 trading plan during the quarter[182](index=182&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed, including forms of warrants, financing agreement amendments, a Revolving Loan Agreement, and executive employment agreements - The report includes several key exhibits, such as the Revolving Loan Agreement with Bowery Consulting Group Inc. and an amendment to the agreement with Alto Opportunity Master Fund[183](index=183&type=chunk) [Signatures](index=35&type=section&id=Signatures)

Core Insights - Shuttle Pharmaceuticals is advancing its Phase 2 clinical trial for Ropidoxuridine, targeting glioblastoma patients, with nearly 50% enrollment achieved and positive early results regarding drug tolerance [1][2][3] - The company aims to finalize enrollment by the end of 2025, with data readout expected in 2026 [1][3] Company Overview - Shuttle Pharmaceuticals is a specialty pharmaceutical company founded in 2012, focused on enhancing outcomes for cancer patients undergoing radiation therapy [8] - The company's mission is to develop therapies that maximize the effectiveness of radiation therapy while minimizing side effects [8] Clinical Trial Details - The Phase 2 trial involves randomizing 40 patients into two dosage groups (1,200 mg/day and 960 mg/day) to identify the optimal dose for glioblastoma treatment [3] - Following the identification of the optimal dose, an additional 14 patients will be enrolled to achieve statistical significance in survival outcomes compared to historical controls [3] Market Opportunity - Approximately 800,000 patients in the US receive radiation therapy annually, with 50% treated for curative purposes, representing a significant market for radiation sensitizers [6] - The market for radiation sensitizers is expected to grow by over 22% in the next five years, driven by the 400,000 patients treated for curative purposes [6] Industry Impact - The trial is seen as critical for the radiation therapy industry, aiming to leverage radiation sensitizers to improve cancer cure rates and patient quality of life [5]

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 ...

Core Viewpoint - Shuttle Pharmaceuticals Holdings, Inc. has announced a public offering of 19,166,667 shares at a price of $0.30 per share, aiming to raise approximately $5.75 million to fund its Phase II clinical trial and other corporate purposes [1][2]. Group 1: Offering Details - The public offering is priced at $0.30 per share, with expected gross proceeds of about $5.75 million before expenses [1]. - The offering is set to close on March 13, 2025, pending customary closing conditions [1]. - WestPark Capital, Inc. is acting as the Sole Book-Runner for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to fund the Phase II clinical trial for the lead product candidate, marketing and advertising services, and general corporate purposes [2]. Group 3: Company Overview - Shuttle Pharmaceuticals, founded in 2012, focuses on improving outcomes for cancer patients undergoing radiation therapy by developing therapies that enhance the effectiveness of radiation while minimizing side effects [5]. - The company aims to increase cancer cure rates and improve patient quality of life through the development of radiation sensitizers [5].

Core Insights - Shuttle Pharmaceuticals Holdings, Inc. has appointed Christopher Cooper as interim Co-Chief Executive Officer to enhance capital markets and business capabilities [1][2] - Dr. Anatoly Dritschilo will continue as Co-CEO, focusing on scientific and clinical trial activities [1][2] - The dual CEO structure aims to improve decision-making, support fundraising, and accelerate key milestones [2] Company Overview - Shuttle Pharmaceuticals, founded in 2012, is a specialty pharmaceutical company focused on improving outcomes for cancer patients undergoing radiation therapy [3] - The company's mission is to develop therapies that maximize the effectiveness of radiation therapy while minimizing side effects [3] - Shuttle Pharma aims to increase cancer cure rates, prolong survival, and improve quality of life through the development of radiation sensitizers [3] Leadership Background - Christopher Cooper has over 27 years of experience in management and finance across various industries, including telecommunications and oil and gas [2] - He has held significant positions such as President and CEO of First Towers & Fiber Corp. and Aroway Energy, Inc. [2] - Cooper has a proven track record in overseeing operations, financial reporting, and raising over $100 million in debt and equity for clients [2]

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].