Shuttle Pharmaceuticals Holdings, Inc.

DEF 14A 1 formdef14a.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE 14A

(Rule 14a - 101)

Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934

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SHUTTLE PHARMACEUTICALS HOLDINGS INC.

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SHUTTLE PHARMACEUTICALS HOLdIngS InC.

2024 Annual Meeting of Stockholders

June 20, 2024

Dear Shareholders,

Over the past year, the team at Shuttle Pharmaceuticals Holdings, Inc. (“Shuttle Pharma”) has made significant progress advancing our mission to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of Radiation Therapy while limiting the late effects of radiation in cancer treatment.

As of the writing of this letter, our lead clinical sensitizer drug candidate, Ropidoxuridine, is set to begin its Phase 2 clinical trial in the coming weeks. The results of this trial will be important as we look to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.

Reaching this important milestone of putting drug into patients doesn’t happen overnight. There are a number of critical steps we have executed during this past year to reach this point, including:

● In August 2023, we completed the manufacturing for the active pharmaceutical ingredient (API) of Ropidoxuridine. To accomplish this, we worked concomitantly with TCG GreenChem to manufacture API and University of Iowa Pharmaceuticals to develop the formulation and packaging of the drug product into capsules for clinical use.

● In September 2023, we received written responses to questions submitted for a Type B pre-Investigational New Drug Application (PIND) meeting with the U.S. Food and Drug Administration (FDA). The FDA’s positive feedback and guidance on the Company’s Chemistry, Manufacturing, and Controls (CMC) and clinical protocol design for Ropidoxuridine provided the pathway to our subsequent IND application submission.

● In December 2023, we formally submitted our IND application to the FDA. The submission included detailed information about the drug, its composition, pharmacology, toxicology data from preclinical studies, proposed clinical trial protocols, and information on manufacturing and quality control.

● In January 2024, we were granted approval to commence the Phase 2 clinical trial following our receipt of the FDA’s ‘Safe to Proceed’ letter.

● Through the first half of 2024, we received central institutional review board (“IRB”) approval for the Phase 2 clinical trial and are in the process of finalizing site enrollment with up to six institutions.

As a general overview, the Phase 2 clinical trial will be conducted with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma patients. This particular group of patients at this time only have radiation as the standard of care, with more than half of the patients surviving for less than 12 months after diagnosis . The Phase 2 trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once we determine the optimal dose, we will then add an additional 14 patients on the optimal dose allowing us to achieve statistical significance with the end point being that of survival compared to historical controls. We expect the trial will be completed over a period of 18 to 24 months.

We are excited to be at this important step in the history of the company as we begin dosing patients. This is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies.

Beyond our focus on radiation sensitizers, in the past year we also announced the formation of Shuttle Diagnostics, through which we aim to develop pretreatment diagnostic blood tests for prostate cancer patients. The first is a PC-RAD test for predicting outcomes following RT for localized prostate cancer, while the second, PSMA-B ligand, is a theranostic molecule offering diagnosis and therapeutics for metastatic prostate cancer. There are currently no available tests on the market that are predictive of success for a specific treatment. We intend to develop Shuttle Diagnostics to offer prognosis and guide treatment decisions, with the goal of providing clinicians and patients with a means of measuring the potential for success of RT for their cancer treatment.

Thank you for your continued support of the mission we have set forth. Long-term drug development is never a linear path. It is our belief that as we achieve important clinical development milestones in the years to come, it will create the desired value for our long-term shareholders.

Respectfully,

/s/ Anatoly Dritschilo, MD

Anatoly Dritschilo, MD

Chairman and CEO

Shuttle Pharmaceuticals Holdings, Inc.

Notice of Annual Meeting of Stockholders of Shuttle Pharmaceuticals Holdings, Inc.

This notice, proxy statement and voting instructions are being mailed to stockholders beginning on or about June [*], 2024.

Your vote is important

Regardless of whether you plan to attend the live meeting, we encourage you to vote as soon as possible in one of the following ways:

/s/ Anatoly Dritschilo

Anatoly Dritschilo, MD

CEO & Chairman

Important Notice Regarding the Availability of Proxy Materials for the Stockholder Meeting to Be Held on July 31, 2024. Our Proxy Statement is available online on our website at https://shuttlepharma.com/. For further information about the Company, including copies of our audited financial statements for the periods ended December 31, 2023, please see our annual report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on March 21, 2024, as well as other SEC filings made since that date.

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