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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): January 8, 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)
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
8.01 Other Events.
On
January 8, 2024, Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company”), issued a press release announcing
that the Company had received the “Safe to Proceed” letter from the U.S. Food and Drug Administration for the Company’s
investigational new drug (IND) application for its Phase II study of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy
in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows Shuttle to commence
the Phase II study and, as a result, the Company is currently finalizing site enrollment with “first patient, first dose”
expected in the coming months.
A
copy of the press release is attached as Exhibit 99.1 hereto and incorporated herein by reference.
The
information in this Item 8.01, including Exhibit 99.1, is furnished and 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 liabilities under that
section, and shall not be deemed to be incorporated by reference into the filings of the Company under the Securities Act or the Exchange
Act, regardless of any general incorporation language in such filings. This Current Report on Form 8-K will not be deemed an admission
as to the materiality of any information of the information contained in this Item 8.01, including Exhibit 99.1.
Forward-Looking
Statements
This
Current Report on Form 8-K contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange
Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Forward-looking statements may relate to statements
concerning future results, strategy and plans of the Company (including certain statements which may be identified by the use of the
words “plans,” “expects,” “does not expect,” “estimated,” “is expected,”
“budget,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates,”
“does not anticipate” or “believes,” or variations of such words and phrases, or state that certain actions,
events or results “may,” “could,” “would,” “might,” “projects,” “will,”
“will be taken,” “occur” or “be achieved”). Forward-looking statements are based on the opinions
and estimates of management of the Company, as of the date such statements are made, and they are subject to known and unknown risks,
uncertainties, assumptions and other factors that may cause the actual results, performance or achievements to be materially different
from those expressed or implied by such forward-looking statements. Additional information on these and other factors that may cause
actual results and the Company’s performance to differ materially is included in the Company’s periodic reports filed with
the SEC, including, but not limited to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and subsequent
Quarterly Reports on Form 10-Q. Copies of the Company’s filings with the SEC are available publicly on the SEC’s website
at www.sec.gov. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date
made. These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligations to update or revise
the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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. |
|
|
|
Date:
January 8, 2024 |
|
|
|
|
|
|
By: |
/s/
Anatoly Dritschilo |
|
Name:
|
Anatoly
Dritschilo |
|
Title: |
Chief
Executive Officer |
Exhibit
99.1
Shuttle
Pharmaceuticals Receives FDA approval to Proceed with Phase II Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma
ROCKVILLE,
Md., January 8, 2024 — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”) today announced they
have received the ‘Safe to Proceed’ letter from the U.S. Food and Drug Administration (FDA) for the Company’s investigational
new drug (IND) application for its Phase II study of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy in patients
with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows Shuttle to commence the
Phase II study.
Shuttle
Pharma is currently finalizing site enrollment with ‘first patient, first dose’ expected in the coming months. Ropidoxuridine
is Shuttle Pharma’s lead radiation sensitizer candidate for use in combination with radiation therapy (RT) to treat glioblastoma,
a deadly malignancy of the brain with no known cure.
“We
are excited to have been granted approval to commence Ropidoxuridine’s Phase II clinical trial following the receipt of the FDA’s
‘Safe to Proceed’ letter,” stated Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. “Radiation
therapy is a proven modality for treating cancers. However, there is a significant need in the market to make radiation more effective.
The results of this Phase II clinical 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.”
An
estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society
and the American Society of Radiation Oncologists, about 50% are treated for curative purposes and the balance for therapeutic care.
The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes, with this number expected
to grow by more than 22% over the next five years.
Shuttle
Pharma has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.
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, and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2023, June 30,
2023 and September 30, 2023, filed with the SEC on May 25, 2023, August 14, 2023 and November 13, 2023, respectively, 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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