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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 15, 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.
Item
2.02 Results of Operations and Financial Condition.
On
August 15, 2023, 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 June 30, 2023.
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:
August 15, 2023 |
|
|
|
|
|
|
By: |
/s/
Anatoly Dritschilo |
|
Name:
|
Anatoly
Dritschilo |
|
Title: |
Chief
Executive Officer |
Exhibit
99.1
Shuttle
Pharmaceuticals Provides Second Quarter 2023 Corporate Update
ROCKVILLE,
Md., August 15, 2023 — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), 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 quarter ended June 30, 2023.
Recent
Highlights
● | On
track to commence Phase II clinical study in the fourth quarter of 2023 for Ropidoxuridine,
Shuttle Pharma’s lead clinical sensitizer drug candidate. |
● | Successfully
completed the initial manufacturing campaign for the active pharmaceutical ingredient (API)
of Ropidoxuridine for use in the Shuttle Pharma’s upcoming Phase II clinical trial. |
● | Received
approval for a Type B pre-IND meeting with the FDA for guidance on the proposed Phase II
clinical trial with a goal of receiving written responses from the FDA by September 18, 2023. |
● | Moved
into new laboratory and office space to assist in furthering the development Shuttle Pharma’s
lead drug candidates and accelerate broader diagnostic capabilities on predictive biomarkers. |
● | Q2
2023 operating expenses (excluding non-cash items) totaled $1.5 million. |
● | At
June 30, 2023, Shuttle Pharma’s cash balance was $8.4 million (including cash, cash
equivalents and marketable securities). |
“We
are making significant progress in the advancement of Ropidoxuridine, our lead clinical sensitizer drug candidate, for treatment in brain
cancer patients undergoing radiation therapy. During the last few months, we successfully completed the initial manufacturing campaign
for the API to be used in the upcoming Phase II clinical trial and received approval from the FDA for a Type B pre-IND meeting to receive
guidance on the trial design,” commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. “We expect to
receive comments from the FDA by mid-September which would put us in position to initiate the clinical trial in the fourth quarter of
this year — a significant inflection point in the development of Ropidoxuridine.”
“The
move into our new laboratory will accommodate not only our Ropidoxuridine research efforts, but also enhance our ability to establish
a CLIA laboratory to advance our diagnostic intellectual property that has been developed with funding from NIH small business innovative
(SBIR) research contracts over the past several years, particularly for our predictive biomarker capabilities for prostate cancer patients.
We are eligible for NIH SBIR ‘bridge’ support to assist in funding the advancements of these efforts. Our recently published
work in premier cancer journals provides insight into the immune response taking place in patients after radiation therapy for cancer
and informs therapeutic strategies for sequencing radiation and immune therapy modalities for cancer treatment,” 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, 2022, filed with the SEC on March 15, 2023, and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2023 and June
30, 2023, filed with the SEC on May 25, 2023 and August 14, 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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