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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): May 14, 2024
SHUTTLE
PHARMACEUTICALS HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-41488 |
|
82-5089826 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
401
Professional Drive, Suite 260
Gaithersburg,
MD 20879
(Address
of principal executive offices) (Zip Code)
(240)
430-4212
(Registrant’s
telephone number, including area code)
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock $0.00001 per share |
|
SHPH |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
2.02 Results of Operations and Financial Condition.
On
May 14, 2024, Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company”), issued a press release providing
a corporate update in connection with the filing of our Quarterly Report on Form 10-Q for the period ended March 31, 2024.
A
copy of the press release is attached as Exhibit 99.1 hereto and incorporated herein by reference.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject
to the liabilities of that Section. Such information may be incorporated by reference in another filing under the Exchange Act or the
Securities Act of 1933, as amended, only if and to the extent that such subsequent filing specifically references such information.
Item
9.01 Financial Statements and Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
SHUTTLE
PHARMACEUTICALS HOLDINGS, INC. |
|
|
|
Dated:
May 14, 2024 |
|
|
|
|
|
|
By: |
/s/
Anatoly Dritschilo |
|
Name: |
Anatoly
Dritschilo |
|
Title: |
Chief
Executive Officer |
Exhibit 99.1
Shuttle
Pharma Provides First Quarter 2024 Corporate Update
GAITHERSBURG,
Md., May 14, 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 Quarterly Report on Form 10-Q for the first quarter ended March 31, 2024.
Recent
Highlights
Shuttle
Pharma’s recent highlights include the following:
|
● |
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. |
|
● |
Received
central institutional review board (“IRB”) approval for the Phase 2 clinical trial. For multicenter studies, the central
IRB is the IRB that conducts reviews on behalf of all study sites that agree to participate in the centralized review process. For
sites at institutions that have an IRB that would ordinarily review research conducted at the site, the central IRB should reach
agreement with each individual institution participating in centralized review and those institutions’ IRBs about how to apportion
the review responsibilities between local IRBs and the central IRB. |
|
● |
Finalizing
site enrollment with up to six institutions with ‘first patient, first dose’ expected in the second quarter of 2024.
|
|
● |
Created
Shuttle Diagnostics, Inc., a wholly owned subsidiary of Shuttle Pharma, which will focus on developing a diagnostics laboratory to
develop its metabolite discovery platform technology and to support 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. |
|
● |
At
March 31, 2024, Shuttle Pharma’s cash balance was approximately $4.2 million (including cash, cash equivalents and marketable
securities). |
Recent
Presentations
● |
Anatoly
Dritschilo, M.D., Chief Executive Officer of Shuttle Pharma, participated in a presentation at the Planet MicroCap Showcase: VEGAS
2024 on May 1, 2023. A webcast link of the presentation can be found on the investor relations page of the Company’s website
or accessed HERE. |
● |
Dr.
Dritschilo also recently participated in a fireside chat at the Lytham Partners 2024 Investor Select Conference and a webcasted
presentation at the Emerging Growth Conference. |
● |
Posted
updated corporate slide presentation in May 2024 highlighting the opportunity for both the company’s radiation sensitizer
portfolio as well as the diagnostic subsidiary. |
“During
the first quarter, we received the ‘Safe to Proceed’ letter from the U.S. Food and Drug Administration (FDA) to commence
our Phase 2 clinical trial of Ropidoxuridine for treatment of patients with glioblastoma,” stated Shuttle Pharma’s Chairman
and CEO, Anatoly Dritschilo, M.D. “We have since received central IRB approval for the trial, and are in the late stages of finalizing
agreements with six institutions participating in the trial. We expect to have ‘first patient, first dose’ in the second
quarter of 2024.”
“Beyond
our focus on radiation sensitizers through both our Ropidoxuridine and HDAC6 inhibitor development, 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.”
“For
our Phase 2 clinical trial of Ropidoxuridine, we look forward to finalizing site enrollment in the coming weeks and beginning the process
of entering our first patients on protocol. The results of this Phase 2 clinical trial will determine clinical efficacy of Ropidoxuridine
as a radiation sensitizer with the goal of increasing cancer cure rates, prolonging patient survival, and improving the quality of life
for patients suffering from glioblastoma,” Dr. Dritschilo 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, 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.
Shuttle
Pharmaceuticals
Anatoly
Dritschilo, M.D., CEO
240-403-4212
info@shuttlepharma.com
Investor
Contacts
Lytham
Partners, LLC
Robert
Blum
602-889-9700
shph@lythampartners.com
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