Shuttle Pharma Provides Corporate Update

Rhea-AI Summary

Shuttle Pharmaceuticals (NASDAQ: SHPH) provided a corporate update on its cancer treatment developments. The company reported significant progress in its Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment, achieving nearly 50% enrollment with 84% of patients completing all seven cycles. The drug is being well-tolerated with toxicity no greater than 2 on a 1-5 scale.

The company has expanded its diagnostic capabilities through a research agreement with UCSF for developing PSMA-targeted ligands for cancer theranostics. Shuttle Pharma also filed a provisional patent for "PSMA-Targeted PARP Inhibitor Conjugates." The company strengthened its board with three new directors and reported $4.5 million in cash as of March 31, 2025. Notable management changes include the resignation of CSO Dr. Anatoly Dritschilo and upcoming retirement of VP Regulatory Michael Vander Hoek.

Positive

• Phase 2 trial of Ropidoxuridine shows positive progress with 50% enrollment and 84% completion rate
• Drug demonstrates good tolerability with low toxicity levels
• Expansion of research capabilities through UCSF partnership for PSMA-targeted therapies
• New patent filing for precision cancer therapy
• Strong institutional presence with trials at major cancer centers

Negative

• Key executive departures with CSO resignation and VP Regulatory retirement
• Limited cash position of $4.5M as of March 2025
• Final trial data readout not expected until 2026

Insights

Pharmaceutical Clinical Trial Expert

Shuttle Pharma shows promising Phase 2 progress for brain cancer drug with good tolerability while advancing diagnostic capabilities.

The Phase 2 trial of Ropidoxuridine for glioblastoma is showing solid progress with 50% enrollment in the randomized portion and 84% completion rate among enrolled patients. This enrollment pace suggests the company is on track to complete recruitment by late 2025, with data readout in 2026 as planned.

The drug's safety profile appears promising, with toxicity reported no greater than grade 2 (on a 1-5 scale). This is particularly significant for glioblastoma treatments, which often struggle with tolerability issues that limit therapeutic efficacy. The initiation of pharmacokinetic/pharmacodynamic (PK/PD) analysis is a critical step that will help establish optimal dosing parameters and potentially enhance the drug's effectiveness.

The trial's execution across multiple prestigious cancer centers (Georgetown, Allegheny, UNC, UVA, Hackensack, and Miami Cancer Institute) strengthens the study's credibility and recruitment capabilities. For glioblastoma—a highly aggressive brain cancer with poor survival rates—completing all seven treatment cycles in 84% of patients suggests good protocol adherence and potentially favorable tolerability.

Parallel to this clinical program, Shuttle's work in PSMA-targeted diagnostics through the UCSF collaboration and the provisional patent filing for PSMA-Targeted PARP Inhibitor Conjugates indicates strategic diversification into the growing theranostics field. This approach could eventually allow for more precise identification and treatment of specific cancer types, particularly prostate cancer where PSMA targeting has shown clinical utility.

Biotech Financial Analyst

Shuttle Pharma demonstrates clinical trial momentum and strategic diversification despite limited cash runway into 2026.

Shuttle Pharmaceuticals' financial position shows $4.5 million cash as of March 31, 2025, following a recent public offering that strengthened their balance sheet. While this provides some operational runway, it's a relatively modest amount considering the company is running a multi-center Phase 2 clinical trial and pursuing diagnostic development programs simultaneously.

The company's strategic focus on radiation sensitizers represents a specialized niche within oncology that addresses the limitations of radiation therapy. This approach could potentially command premium pricing if approved, as it improves the effectiveness of an established treatment modality rather than replacing existing therapies.

The leadership transitions, including the resignation of co-founder Dr. Dritschilo from both board and CSO roles and the retirement of the VP of Regulatory Affairs, represent significant organizational changes that warrant attention. These departures of key scientific and regulatory leadership during an active Phase 2 trial period could potentially impact institutional knowledge and program continuity.

The company's intellectual property strategy appears to be strengthening with their new provisional patent filing for PSMA-Targeted PARP Inhibitor Conjugates. This connection to the medicinal chemistry work behind approved products Pylarify and Pluvitco suggests potential commercial relevance if development is successful.

For a Nasdaq-listed clinical-stage biotech, Shuttle's market position hinges primarily on the success of Ropidoxuridine's Phase 2 results expected in 2026. The addition of three new board members with business and legal backgrounds signals a shift toward more commercially-focused governance as the company approaches potential value inflection points.

GAITHERSBURG, Md., May 15, 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.

Shuttle Pharma’s recent highlights:

• Phase 2 clinical trial of Ropidoxuridine for treatment of patients with glioblastoma highlights include:
  • Patient enrollment nears milestone as nearly 50% enrollment has been achieved in the initial randomized portion of the trial.
  • 84% of the enrolled patients have completed all seven cycles.
  • Ropidoxuridine is being reported as well tolerated by treatment sites and toxicity is no greater than 2 on a scale of 1-5.
  • Analyzing pharmacokinetic/pharmacodynamic samples to compare the relationship between dose and response in terms of the extent and duration of Ropidoxuridine’s action has begun.
  • Enrollment continues at nationally recognized cancer centers, including 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.
  • Objective is to finalize enrollment later this year with follow up and data read out in 2026.
• Other key activities include:
  • Continued advancement of the Company’s Diagnostics subsidiary through the entry of a sponsored research agreement with the University of California, San Francisco (UCSF) to advance pre-clinical development of a ligand to the prostate-specific membrane antigen (PSMA) as a potential diagnostic and therapeutic, or theranostic, molecule. Theranostic molecules are suitable for diagnosis and therapy of cancers.
  • Filed a key provisional patent application with the United States Patent and Trademark Office (USPTO) entitled “PSMA-Targeted PARP Inhibitor Conjugates for Precision Cancer Therapy.” The filing comes through Shuttle Pharma’s collaboration with internationally renowned medicinal chemist, Dr. Alan Kozikowski. Dr. Kozikowski’s original medicinal chemistry research performed in collaboration with Professor Joseph Neale and conducted at Georgetown University Medical Center were a component in the creation of both Pylarify and Pluvitco.
  • Appointed three new members to the Company’s board of directors (George Scorsis, Oleh Nabyt and Joseph Tung), offering business and legal backgrounds to help guide the Company going forward.
  • Strengthened the Company’s balance sheet through the completion of an underwritten public offering. Cash and cash equivalents at March 31, 2025 were $4.5 million.

“We are thrilled with the progress of our Phase 2 clinical trial for Ropidoxuridine in treating glioblastoma, a devastating brain cancer,” commented Shuttle Pharma's interim Chief Executive Officer, Chris Cooper. “With nearly 50% of patient enrollment achieved in the initial randomized portion and 84% of enrolled patients completing all seven cycles, the trial is advancing steadily at esteemed cancer centers. Ropidoxuridine has been well-tolerated and we have begun analyzing pharmacokinetic and pharmacodynamic samples to optimize dosing and response. Our goal is to complete enrollment later this year, with follow-up and data readouts anticipated in 2026.”

"In parallel, Shuttle Pharma is making significant strides in our Diagnostics subsidiary through a sponsored research agreement with UCSF to develop a PSMA-targeted ligand for potential theranostic applications in prostate cancer. We’ve also filed a provisional patent for 'PSMA-Targeted PARP Inhibitor Conjugates for Precision Cancer Therapy,' in collaboration with Dr. Alan Kozikowski, an internationally renowned medicinal chemist. Additionally, we have enhanced our business focus through the addition of new board members and a strengthened balance sheet through our recent public offering. These actions help prepare us for the accelerated achievement of key milestones in the future.”

On Friday, May 9, 2025, Dr. Anatoly Dritschilo announced his resignation from the Company’s Board of Directors and as Chief Scientific Officer. Additionally, Michael Vander Hoek, the Company’s Vice President, Regulatory, announced his retirement with an effective date of June 10, 2025.

“Finally, I want to thank Dr. Dritschilo and Michael Vander Hoek for their many contributions to Shuttle Pharma since its inception. We look forward to building off the work completed to date to bring us closer to offering hope for patients battling this aggressive disease," Mr. Cooper concluded.

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
Chief Executive Officer
info@shuttlepharma.com

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

FAQ

What is the current status of SHPH's Phase 2 Ropidoxuridine trial for glioblastoma?

The trial has achieved nearly 50% enrollment in its initial randomized portion, with 84% of enrolled patients completing all seven cycles. The drug is well-tolerated with toxicity no greater than 2 on a 1-5 scale. Final enrollment is expected later in 2025 with data readout in 2026.

How much cash does Shuttle Pharmaceuticals (SHPH) have as of March 2025?

Shuttle Pharmaceuticals reported cash and cash equivalents of $4.5 million as of March 31, 2025, following the completion of an underwritten public offering.

What management changes occurred at Shuttle Pharmaceuticals (SHPH) in May 2025?

Dr. Anatoly Dritschilo resigned from his positions as Board Director and Chief Scientific Officer, and Michael Vander Hoek, VP of Regulatory, announced his retirement effective June 10, 2025.

What new partnerships or developments has SHPH announced for cancer diagnostics?

SHPH entered a sponsored research agreement with UCSF to develop PSMA-targeted ligands for cancer theranostics and filed a provisional patent for PSMA-Targeted PARP Inhibitor Conjugates for Precision Cancer Therapy.

Which cancer centers are participating in SHPH's Ropidoxuridine trial?

The trial is being conducted at Georgetown University Medical Center, Allegheny Health Network Cancer Institute, UNC Medical Center, UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, and Miami Cancer Institute.