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].

Financial Performance - The company reported a net loss of $3,784,082 for the three months ended September 30, 2024, compared to a net loss of $1,792,754 for the same period in 2023, representing an increase of 111%[103] - For the nine months ended September 30, 2024, the company reported a net loss of approximately $7.5 million with no revenues, and a working capital deficit of approximately $1.3 million[115] - Cash used in operating activities for the nine months ended September 30, 2024, was $4.6 million, a 3% increase from $4.5 million in the same period of 2023[122] Expenses - Research and development (R&D) expenses for the three months ended September 30, 2024, were $1,400,564, an increase of 34% from $1,045,177 in the same period in 2023[103] - Legal and professional expenses surged by 358% to $1,322,002 for the three months ended September 30, 2024, compared to $288,416 in the prior year[107] - The company’s total operating expenses for the three months ended September 30, 2024, were $3,051,561, a 91% increase from $1,599,146 in the same period in 2023[103] - For the nine months ended September 30, 2024, legal and professional expenses increased by 117% to $2,323,013 compared to $1,072,728 in the same period in 2023[113] Capital and Funding - The company raised $3.9 million in net cash from an equity offering in October 2024, issuing 2.9 million shares and warrants with an exercise price of $1.40[116] - The company completed an offering of senior secured convertible bridge notes in October 2024, receiving $790,000 in cash, which is not expected to be sufficient to fund operations through the next twelve months[116] - The company has incurred significant expenses related to the Phase II clinical trial of Ropidoxuridine, necessitating additional capital to complete the trial and fund ongoing operations[118] Working Capital and Assets - As of September 30, 2024, total current assets were $0.4 million, a decrease of 94% from $5.6 million as of December 31, 2023, while current liabilities increased by 59% to $1.7 million[121] - The company has a working capital deficiency of $1.3 million as of September 30, 2024, compared to a working capital of $4.6 million as of December 31, 2023, indicating a substantial decline[121] - Cash on hand as of September 30, 2024, was $156,652, a decrease of 96% from $3.9 million at the end of 2023[122] Compliance and Regulatory Matters - The company reported stockholders' equity of $801,434 as of June 30, 2024, which is below the Nasdaq minimum requirement of $2,500,000[100] - The company executed a 1-for-8 reverse stock split on August 13, 2024, to meet Nasdaq listing requirements[98] - The company submitted a plan to Nasdaq on October 15, 2024, to regain compliance with the minimum stockholders' equity standard[102] Clinical Development - The company has commenced its Phase II clinical study of Ropidoxuridine, enrolling the first three patients in October 2024[97] Internal Controls and Legal Matters - The company has identified material weaknesses in its internal controls over financial reporting, leading to the need for restatements of its 2023 and 2022 financial statements[140] - The company has engaged a third-party consulting firm to assist with SEC reporting and technical accounting matters to address identified weaknesses[141] - The company is not currently involved in any legal proceedings that could materially affect its business or financial condition[142] - The company maintains insurance policies deemed adequate based on business risks and historical experience[142]

Core Insights - Shuttle Pharmaceuticals is advancing its Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment, having successfully dosed the first three patients [1][2] - The company has finalized agreements with six clinical trial sites, including major cancer centers, to conduct the trial [1][2] - Shuttle Pharma has improved its financial position by paying off a $4.3 million convertible note and completing a $4.5 million public offering [1][2] Company Developments - The Phase 2 clinical trial will enroll 40 patients with IDH wild-type, methylation negative glioblastoma, aiming to determine the optimal dose of Ropidoxuridine [3] - The trial is expected to take 18 to 24 months to complete, with the primary endpoint being survival compared to historical controls [3] - The company aims to leverage radiation sensitizers to enhance cancer treatment outcomes and improve patient quality of life [6] Market Opportunity - Approximately 800,000 patients in the US receive radiation therapy for cancer annually, with 400,000 treated for curative purposes [4] - The market for radiation sensitizers is projected to grow by over 22% in the next five years, indicating significant potential for Shuttle Pharma's products [4]

GAITHERSBURG, Md., Oct. 28, 2024 (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 it has finalized agreements with all six of the planned site enrollment locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma following the entry into a ...

GAITHERSBURG, Md., Sept. 16, 2024 (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 it has entered into agreements with two additional site locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma. Four of the planned six trial sites are ...

GAITHERSBURG, Md., Sept. 04, 2024 (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), today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the second quarter ended June 30, 2024. Shuttle Pharma's recent highlights include the following: Enrollment of patients in t ...