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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): August 3, 2023
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)
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.
On
August 3, 2023, Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company”), issued a press release announcing
that the Company, through its manufacturing partner TCG GreenChem, had successfully completed the initial manufacturing campaign for
the active pharmaceutical ingredient of Ropidoxuridine for use in the Company’s upcoming Phase II clinical trial to be conducted
in brain cancer patients undergoing radiation therapy. In addition, the press release announced that the FDA approved the Company’s
requested Type B pre-IND meeting with the FDA for guidance on the Company’s proposed Phase II clinical trial, with the goal of
receiving a written response from the FDA by September 18, 2023. With this, the Company believes it remains on track to commence its
Phase II clinical trials in the fourth quarter of 2023. A copy of the press release is furnished herewith as Exhibit 99.1.
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.
Dated:
|
August
3, 2023 |
|
|
|
|
SHUTTLE
PHARMACEUTICALS HOLDINGS, INC. |
|
|
|
|
By: |
/s/
Anatoly Dritschilo |
|
Name:
|
Anatoly
Dritschilo |
|
Title: |
Chief
Executive Officer |
|
Exhibit
99.1
Shuttle Pharmaceuticals Completes Manufacturing of Active Pharmaceutical Ingredient (API) for Use in Clinical Trial
ROCKVILLE,
Md., Aug. 3, 2023 /PRNewswire/ — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty
pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), today announced that
TCG GreenChem has successfully completed the initial manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine
for use in the Company’s upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy.
“Shuttle
has been working 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. Today’s announcement of successfully completing the API manufacturing
is an important step in the advancement Ropidoxuridine, our lead clinical sensitizer drug candidate, towards the commencement of our
upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy,” commented Shuttle Pharma’s Chairman
and CEO, Anatoly Dritschilo, M.D.
In
addition, Shuttle’s recent request for a Type B pre-IND meeting with the FDA for guidance on the proposed Phase II clinical trial
has been approved with a goal of receiving written responses from the FDA by September 18, 2023. With this, the Company believes it remains
on track to commence its Phase II clinical study in the fourth quarter of 2023.
About
Shuttle Pharmaceuticals
Founded
in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharmaceuticals 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, 2022, filed with the SEC on March 15, 2023, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the
SEC on May 25, 2023, 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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