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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock SHPH The Nasdaq Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission f ...

GAITHERSBURG, Md., Aug. 14, 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 of the six site locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma. Site initiation visits have been complete ...

SP-1-303, initially discovered and synthesized in Shuttle Pharma's laboratories by Dr. Grindrod, is one of the Company's pre-clinical selective Class I HDAC inhibitors. Histone deacetylase inhibitors sensitize cancers to the effects of radiation, protect normal tissues from radiation injury and activate the immune system. SP-1-303 is a selective Class I HDAC inhibitor that inhibits HDAC1, 3 and 6 and has direct cellular toxicity in ER + BC. Furthermore, SP-1-303 increases the PD-L1 expression level in a tim ...

Core Insights - Shuttle Pharmaceuticals Holdings, Inc. has published a manuscript demonstrating the effectiveness of its HDAC inhibitor SP-1-303 in inhibiting the growth of estrogen receptor positive breast cancer cells [1][6] - The CEO of Shuttle Pharmaceuticals emphasized the potential of SP-1-303 as a promising therapeutic approach for treating estrogen receptor positive breast cancers through combined targeting of Class I HDACs and ATM [2] Company Overview - Founded in 2012 by faculty members of Georgetown University Medical Center, Shuttle Pharmaceuticals focuses on improving outcomes for cancer patients undergoing radiation therapy [5] - The company's mission is to enhance the effectiveness of radiation therapy while minimizing side effects, aiming to increase cancer cure rates and improve patient quality of life [5] Research and Development - The published manuscript titled "Dual-targeting class I HDAC inhibitor and ATM activator, SP-1-303, preferentially inhibits estrogen receptor positive breast cancer cell growth" was authored by Dr. Mira Jung and Dr. Scott Grindrod [6] - SP-1-303 is a selective Class I HDAC inhibitor that shows direct cellular toxicity in estrogen receptor positive breast cancer and enhances PD-L1 expression, suggesting potential for combination with immune checkpoint blockers [7]

Mr. Lorber is a CPA with more than 40 years of professional finance experience, including 15 years with Legg Mason, Inc. ("Legg Mason"), one of the world's larger public global asset management firms where he served as a Managing Director and Chief Accounting Officer until its sale in 2020. More recently, Mr. Lorber has served in leadership roles with several privately held businesses, overseeing finance, IT and HR functions. Prior to Legg Mason, Mr. Lorber served as Internal Audit Director of Freddie Mac a ...