Shuttle Pharma Provides Second Quarter 2025 Corporate Update

Rhea-AI Summary

Shuttle Pharmaceuticals (Nasdaq: SHPH), a specialty pharmaceutical company focused on improving radiation therapy outcomes, provided a Q2 2025 corporate update highlighting significant progress in its clinical trials. The company's Phase 2 trial of Ropidoxuridine for glioblastoma treatment has reached 63% enrollment, with 72% of enrolled patients completing all seven cycles and reporting good tolerability.

Key financial developments include securing $4.25 million through a private placement, ending Q2 with $4.8 million in cash. The company completed a reverse stock split for Nasdaq compliance and strengthened its leadership by appointing George Scorsis as Board Chairman and Christopher Cooper to the Board. The Phase 2 trial completion is expected in late 2025, with data readouts anticipated in 2026.

Positive

• Phase 2 trial of Ropidoxuridine achieved 63% enrollment with 72% completion rate
• Secured $4.25 million in private placement funding
• FDA Orphan Drug Designation provides potential marketing exclusivity
• Large market opportunity with 400,000 potential patients, expected to grow 22% in 5 years

Negative

• Required reverse stock split for Nasdaq compliance, indicating previous stock price challenges
• CEO position currently interim, suggesting leadership transition period
• Final trial data readouts not expected until 2026

Insights

Biotech Analyst

Shuttle Pharma reports solid Phase 2 trial progress for glioblastoma treatment with 63% enrollment and good tolerability amid financial strengthening.

Shuttle Pharmaceuticals' Q2 2025 update reveals encouraging progress in their Phase 2 clinical trial for Ropidoxuridine in glioblastoma patients. The trial has reached 63% enrollment in the initial randomized portion, with 72% of enrolled patients completing all seven treatment cycles. Importantly, treatment centers are reporting the drug as well-tolerated, which is critical for radiation sensitizers where side effect profiles can limit clinical utility.

The company has significantly strengthened its financial position, ending the quarter with $4.8 million in cash following a $4.25 million private placement in June 2025. This funding extension provides runway for the company to potentially reach important clinical milestones. The reverse stock split executed in June represents a strategic move to maintain Nasdaq compliance, which preserves institutional investor access and market liquidity.

The trial design itself shows methodical approach to dose optimization. The initial randomization between 1,200 mg/day and 960 mg/day doses will determine the optimal regimen before enrolling 14 additional patients at that dose to achieve statistical significance. This adaptive design efficiently identifies the most effective dose while minimizing patient exposure to suboptimal treatment.

For glioblastoma—a deadly brain malignancy with no known cure—the Orphan Drug Designation already secured provides potential marketing exclusivity upon FDA approval, enhancing the commercial potential. The broader market opportunity is substantial, with approximately 400,000 US patients annually receiving radiation therapy for curative purposes, a number projected to grow by 22% over five years.

The company's partnership with multiple prestigious cancer centers (Georgetown, UNC, UVA, etc.) adds credibility to the trial and facilitates patient recruitment. The anticipated completion of enrollment later this year positions the company for potential data readouts in 2026, which will be critical valuation catalysts.

GAITHERSBURG, Md., Aug. 14, 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 provided a corporate update.

Recent Activities:

• Patient enrollment in the Company’s Phase 2 clinical trial of Ropidoxuridine for treatment of patients with glioblastoma reached 63% in the initial randomized portion of the trial.
• 72% of the enrolled patients have completed all seven cycles.
• Ropidoxuridine is being reported by treatment sites as well tolerated.
• Ended the quarter with $4.8 million in cash following the closing of a private placement pursuant to a securities purchase agreement with an accredited investor for aggregate gross proceeds of $4.25 million in June 2025.
• Completed a reverse stock split in June 2025 as part of strategic Nasdaq compliance initiative.
• Appointed George Scorsis as the Chairman of the Board of Directors and appointed Christopher Cooper, our current Interim Chief Executive Officer to our Board of Directors. Mr. Scorsis has over 25 years of experience leading companies in highly regulated industries to rapid growth. Mr. Cooper has over 27 years of management and finance experience.

“We are encouraged by the progress in our Phase 2 clinical trial of Ropidoxuridine for glioblastoma, with 63% enrollment having recently been achieved. Importantly, 72% of enrolled patients have completed all seven cycles with treatment reported as being well-tolerated,” commented Shuttle Pharma's interim Chief Executive Officer, Chris Cooper. “We are working closely with our primary third-party CRO, Theradex Systems, to continue execution of the clinical trial in combination with leading cancer centers across the U.S. Our goal continues to remain completion of enrollment later this year, with follow-up and data readouts anticipated in 2026.”

Ropidoxuridine (IPdR) is Shuttle Pharma's lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle Pharma previously received Orphan Drug Designation from the FDA, providing Shuttle Pharma with potential marketing exclusivity upon obtaining FDA approval for treatment of this disease.

The Phase 2 clinical trial design initially randomizes 40 patients into two different dose levels of drug, with 20 patients receiving 1,200 mg/day and 20 patients receiving 960 mg/day, to determine an optimal dose for use in glioblastoma patients in combination with RT. After the optimal dose is identified, 14 additional patients will be enrolled at the optimal dose to reach statistical significance with the end-point demonstrating increased survival as compared to historical controls.

The Phase 2 clinical trial is conducted at Georgetown University Medical Center, Allegheny Health Network (AHN) Cancer Institute, UNC Medical Center, the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, and Miami Cancer Institute, part of Baptist Health South Florida.

An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% are treated for curative purposes and the balance for palliative therapeutic care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes, with this number expected to grow by more than 22% over the next five years.

More information about the Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.

About Shuttle Pharmaceuticals

Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy. For more information, please visit our website at www.shuttlepharma.com.

Safe Harbor Statement

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning the development of our company. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the “Risk Factors” section of Shuttle Pharma’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 26, 2025, as well other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Shuttle Pharmaceuticals
Chris Cooper

Interim Chief Executive Officer
info@shuttlepharma.com

Investor Contacts
Lytham Partners, LLC
602-889-9700
shph@lythampartners.com 

FAQ

What is the current status of Shuttle Pharmaceuticals (SHPH) Phase 2 trial for Ropidoxuridine?

The Phase 2 trial has reached 63% enrollment, with 72% of enrolled patients completing all seven treatment cycles. The drug is being reported as well-tolerated by treatment sites.

How much cash does Shuttle Pharmaceuticals (SHPH) have after Q2 2025?

Shuttle Pharma ended Q2 2025 with $4.8 million in cash, which includes $4.25 million raised through a private placement in June 2025.

What is the market potential for Shuttle Pharmaceuticals' (SHPH) radiation sensitizers?

The market includes 400,000 patients treated with radiation therapy for curative purposes annually in the US, with expected growth of 22% over the next five years.

When will Shuttle Pharmaceuticals (SHPH) complete the Phase 2 trial for glioblastoma treatment?

The company expects to complete enrollment in late 2025, with follow-up and data readouts anticipated in 2026.

What recent management changes has Shuttle Pharmaceuticals (SHPH) made?

SHPH appointed George Scorsis as Chairman of the Board and Christopher Cooper (current Interim CEO) to the Board of Directors.