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Shuttle Pharma Provides Fourth Quarter 2023 Corporate Update GAITHERSBURG, Md.

Key Takeaway: Shuttle Pharmaceuticals Holdings, Inc. has provided a corporate update, announcing several key developments in its drug and diagnostic efforts. The company received FDA approval to initiate a Phase 2 clinical trial for Ropidoxuridine, targeting glioblastoma, which is expected to start in Q2 2024. Additionally, Shuttle Pharma has established a subsidiary, Shuttle Diagnostics, to focus on predictive diagnostic tests for prostate cancer, and has entered exclusive licensing agreements to enhance its biomarker program. The company also plans to raise up to $4.5 million through a Rights Offering to support its initiatives.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA approval to proceed with Phase 2 clinical trial of Ropidoxuridine for glioblastoma.
  • Creation of Shuttle Diagnostics Inc. to develop a diagnostics laboratory.
  • Exclusive licensing agreements for advancing prostate cancer diagnostics.

Full Press Release Details

Pharma Provides Fourth Quarter 2023 Corporate Update
Md., March 22, 2024 -- 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 Annual Report on Form 10-K for the year ended December 31, 2023.
Received FDA approval to proceed with the Phase 2 Clinical Trial of Ropidoxuridine for treatment of patients with glioblastoma, a deadly malignancy of the brain with no known cure.
Finalizing site enrollment with first patient, first dose' expected in the second quarter of 2024.
Created Shuttle Diagnostics, Inc., a wholly owned subsidiary of Shuttle Pharma, focused on developing a diagnostics laboratory to develop its metabolite discovery platform technology and to perform multi-institutional clinical trials.
Entered into an exclusive agreement to license certain intellectual property from Georgetown University to advance the Company's predictive biomarker program focused on developing a predictive diagnostic test for prostate cancer patients who are considering elective radiation therapy.
Obtained an exclusive license for PSMA-B intellectual property for advancing research into diagnostic and therapeutic applications of metastatic prostate cancer.
Announced intent to commence a Rights Offering where it plans to raise up to $4.5 million through the distribution of subscription rights and the exercise thereof to advance Shuttle Diagnostics, Inc. Details of the Rights Offering can be found here (https://www.prnewswire.com/news-releases/shuttle-pharma-announces-its-intent-to-pursue-a-rights-offering-302060196.html ).
At December 31, 2023, Shuttle Pharma's cash balance was $5.5 million (including cash, cash equivalents and marketable securities).
Anatoly Dritschilo, M.D., Chief Executive Officer of Shuttle Pharma, participated in a fireside chat at the Lytham Partners 2024 Investor Select Conference. The webcast can be accessed HERE (https://www.youtube.com/watch?v=KzjTkqPEuf8&list=PL0eo-Gh54b2kNhhLR4ZKfNMweYkRaqSIh&index=26) .
Shuttle Pharma presented at the Emerging Growth Conference on March 6, 2024. A webcast link of the presentation can be found on the investor relations page of Shuttle Pharma's website or accessed HERE (https://www.youtube.com/watch?v=7JUWtjGqanc) .
Updated corporate slide presentation (https://shuttlepharma.com/wp-content/uploads/2024/03/Shuttle-Pharma-Investor-Presentation-February-2024.pdf) to highlight the opportunity for both Shuttle Pharma's radiation sensitizer portfolio as well as the diagnostic subsidiary.
achieved a significant milestone in January 2024 with the receipt of the Safe to Proceed' letter from the U.S. Food and
Drug Administration (FDA) to commence Ropidoxuridine's Phase 2 clinical trial," stated Shuttle Pharma's Chairman and
CEO, Anatoly Dritschilo, M.D. "We are currently finalizing site enrollment with first patient, first dose' expected
in the second quarter of 2024. The results of this Phase 2 clinical trial will be important as we look to leverage radiation sensitizers
to increase cancer cure rates, prolong patient survival, and improve the quality of life for patients suffering from glioblastoma.
our focus on radiation sensitizers through both our Ropidoxuridine and HDAC6 development, we also announced the formation of Shuttle
Diagnostics, which is focused on developing pretreatment predictive blood tests for prostate cancer patients. These tests will allow
for the assessment of risk for cancer treatment success or failure, while informing therapeutic decision making and follow-up management.
In 2019, the estimated global prostate cancer diagnostic market was $2.83 billion, however, none of the currently available tests are
predictive of success of a specific treatment. We aim to meet this key unmet need for a minimally invasive diagnostic test that provides
the clinician and patient with a measurement of the potential success of RT for their cancer treatment.
expect the coming few months will be filled with key developments and milestones, including the commencement of our Phase 2 clinical
trial for Ropidoxuridine for treatment of patients with glioblastoma and the advancement of our opportunity within diagnostics. Our team
is laser-focused on execution of the key deliverables that we believe will drive value for both patients and shareholders," Dr.
Dritschilo concluded.
Shuttle Pharmaceuticals
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.
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, 2023, filed with the SEC on March 20, 2024, 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.
Dritschilo, M.D., CEO

Frequently Asked Questions

What recent trial did Shuttle Pharma receive FDA approval for?

Shuttle Pharma received FDA approval for the Phase 2 Clinical Trial of Ropidoxuridine for glioblastoma.

When is the first patient expected to begin treatment?

The first patient is expected to receive their first dose in the second quarter of 2024.

What is the focus of Shuttle Diagnostics, Inc.?

Shuttle Diagnostics, Inc. focuses on developing a diagnostics laboratory for metabolite discovery.

How much funding does Shuttle Pharma aim to raise in its Rights Offering?

Shuttle Pharma plans to raise up to $4.5 million through a Rights Offering.

What is the goal of Shuttle Pharma's radiation sensitizers?

The goal is to enhance cancer cure rates and improve quality of life for patients.

Last updated: Mar 22, 2024