Workflow
Shuttle Pharmaceuticals (SHPH)
icon
Search documents
Shuttle Pharma Provides Second Quarter 2025 Corporate Update
Globenewswire· 2025-08-14 20:05
Core Viewpoint - Shuttle Pharmaceuticals is making significant progress in its Phase 2 clinical trial of Ropidoxuridine for glioblastoma, with 63% enrollment achieved and 72% of enrolled patients completing all treatment cycles, indicating a well-tolerated therapy [1][6]. Recent Activities - The Phase 2 clinical trial is being conducted in collaboration with leading cancer centers across the U.S. and aims to complete enrollment later this year, with data readouts expected in 2026 [1][3]. - Ropidoxuridine is designed as a radiation sensitizer to improve treatment outcomes for glioblastoma patients, a type of brain cancer with no known cure [1][7]. Clinical Trial Design - The trial involves randomizing 40 patients into two dose levels: 20 patients receiving 1,200 mg/day and 20 patients receiving 960 mg/day, to identify the optimal dose for glioblastoma treatment in combination with radiation therapy [2]. Market Opportunity - Approximately 800,000 patients in the U.S. receive radiation therapy for cancer annually, with 50% treated for curative purposes. The market for radiation sensitizers targets the 400,000 patients treated curatively, expected to grow by over 22% in the next five years [4]. Financial Update - The company ended the quarter with $4.8 million in cash after a private placement that raised $4.25 million in June 2025 [6]. - A reverse stock split was completed in June 2025 as part of a strategic initiative for Nasdaq compliance [6]. Leadership Changes - George Scorsis was appointed as the Chairman of the Board, and Christopher Cooper, the current Interim CEO, was appointed to the Board, both bringing extensive experience in management and finance [6].
Shuttle Pharmaceuticals (SHPH) - 2025 Q2 - Quarterly Report
2025-08-12 22:59
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 001-41488 SHUTTLE PHARMACEUTICALS HOLDINGS, INC. (Exact name of registrant as specified in its charter) ...
Shuttle Pharmaceuticals Announces Closing of $4.25 Million Private Placement Priced At-the-Market
Globenewswire· 2025-06-24 20:10
GAITHERSBURG, Md., June 24, 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 that it closed its previously announced private placement pursuant to a securities purchase agreement with an accredited investor for aggregate gross proceeds of $4.25 million, before deducting fees ...
Shuttle Pharmaceuticals Announces Pricing of $4.25 Million Private Placement Priced At-the-Market
Globenewswire· 2025-06-20 19:55
Group 1 - Shuttle Pharmaceuticals Holdings, Inc. has entered into a securities purchase agreement with an accredited investor for gross proceeds of $4.25 million, intended for acquisitions, marketing, and general corporate purposes [1][2]. - The company will issue 1,180,877 shares of common stock at a purchase price of $3.60 per share, with the offering expected to close around June 23, 2025 [2][3]. - WestPark Capital, Inc. is acting as the exclusive placement agent for the offering, with additional details to be filed in a Form 8-K with the SEC [3]. Group 2 - Shuttle Pharmaceuticals is focused on improving outcomes for cancer patients treated with radiation therapy by developing therapies that enhance the effectiveness of radiation while minimizing side effects [6]. - The company's mission includes increasing cancer cure rates, prolonging patient survival, and improving quality of life through the development of radiation sensitizers [6].
Shuttle Pharma Announces Reverse Stock Split will Become Effective on June 16, 2025, at 12:01 a.m., Eastern Time
Globenewswire· 2025-06-12 16:00
Group 1 - Shuttle Pharmaceuticals Holdings, Inc. will implement a reverse stock split effective June 16, 2025, at 12:01 a.m. Eastern Time, with the common stock continuing to trade under the symbol "SHPH" on Nasdaq [1][2] - The reverse stock split will convert every 25 shares of the Company's common stock into 1 share, reducing the total number of outstanding shares from approximately 26,210,037 to about 1,048,401 shares [2] - This action is part of Shuttle's strategic plan to comply with Nasdaq's continued listing requirements and to strengthen the Company's long-term capital structure [3] Group 2 - Shuttle Pharmaceuticals is focused on improving outcomes for cancer patients undergoing radiation therapy by developing therapies that enhance the effectiveness of radiation while minimizing side effects [4] - The Company aims to increase cancer cure rates, prolong patient survival, and improve quality of life through the development of radiation sensitizers, which can be used alone or in combination with other treatments [4]
Shuttle Pharma Announces Proposed Reverse Stock Split as Part of Strategic Nasdaq Compliance Initiative
Globenewswire· 2025-06-12 12:30
Core Viewpoint - Shuttle Pharmaceuticals Holdings, Inc. has announced a proposed reverse stock split of its common stock at a ratio of 25-for-1, subject to Nasdaq approval, aimed at maintaining compliance with listing requirements and strengthening its capital structure [1][3]. Group 1: Reverse Stock Split Details - At the effective time of the reverse stock split, every 25 shares of the Company's common stock will be combined into 1 share, reducing the total number of shares from 26,210,037 to approximately 1,048,401 shares [2]. - The reverse stock split will also apply to common stock issuable upon the exercise of outstanding RSU grants and warrants, with no fractional shares issued; fractional entitlements will be rounded up to the next highest whole number [2]. Group 2: Company Overview - Shuttle Pharmaceuticals is a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy [4]. - The Company's mission is to enhance the effectiveness of radiation therapy while minimizing side effects, aiming to increase cancer cure rates, prolong patient survival, and improve quality of life [4].
Shuttle Pharma Appoints George Scorsis Chairman of the Board of Directors
Globenewswire· 2025-06-04 20:01
Core Viewpoint - Shuttle Pharmaceuticals Holdings, Inc. has appointed George Scorsis as the Chairman of the Board of Directors, bringing extensive experience in leading companies in regulated industries to rapid growth [1][2]. Company Overview - Shuttle Pharmaceuticals is a discovery and development stage specialty pharmaceutical company focused on enhancing outcomes for cancer patients undergoing radiation therapy (RT) [4]. - The company's mission is to develop therapies that maximize the effectiveness of RT while minimizing side effects, aiming to increase cancer cure rates, prolong patient survival, and improve quality of life [4]. Leadership Experience - George Scorsis has over 25 years of experience in various industries, including alcohol, energy drinks, and biotech, with notable positions such as President at Mettrum Health Corp. and CEO of Liberty Health Sciences [2]. - He currently holds chairmanship roles at Entourage Health Corp. and AWAKN Life Sciences, both publicly traded [2]. Strategic Vision - Scorsis expressed his commitment to leveraging the company's radiation sensitizers to improve cancer treatment outcomes, particularly for glioblastoma patients, aiming to enhance cure rates and patient quality of life [3].
Shuttle Pharma Provides Corporate Update
Globenewswire· 2025-05-15 20:45
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]
Shuttle Pharmaceuticals (SHPH) - 2025 Q1 - Quarterly Report
2025-05-08 21:29
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)
Shuttle Pharma FDA Orphan-Drug Nears Patient Enrollment Milestone for Phase 2 Clinical Trial
GlobeNewswire News Room· 2025-05-08 20:01
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]