Filed
pursuant to Section 424(b)(3)
Registration
No. 333-284889
PROSPECTUS

SHUTTLE
PHARMACEUTICALS HOLDINGS, INC.
1,340,921
Shares of Common Stock
17,825,746
Pre-Funded Warrants to Purchase 17,825,746
Shares of Common Stock
17,825,746 Shares
of Common Stock Underlying the Pre-Funded Warrants
This is a firm commitment underwritten offering
of 1,340,921 shares (the “Shares”) of common stock, par value $0.00001 per share (“common stock”) and
17,825,746 pre-funded warrants to purchase shares common stock in lieu thereof (the “Pre-Funded Warrants”).
The public offering price for each share of common
stock or each Pre-Funded Warrant is $0.30.
We
are offering Pre-Funded Warrants to certain purchasers whose purchase of shares of common stock in this offering would otherwise result
in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election
of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering, the opportunity to
purchase, if any such purchaser so chooses, Pre-Funded Warrants, in lieu of shares of common stock.
The public offering price of each Pre-Funded Warrant will be equal to the price at which one
share of common stock is sold to the public in this offering, minus $0.001, and the exercise price of
each Pre-Funded Warrant will be $0.001 per share. The Pre-Funded Warrants will be immediately exercisable and may be exercised at any
time until all of the Pre-Funded Warrants are exercised in full. For each Pre-Funded Warrant we sell, the number of shares of common
stock we are offering will be decreased on a one-for-one basis.
This prospectus also includes the shares of common stock issuable upon exercise
of the Pre-Funded Warrants. See “Description of Securities We Are Offering” in this prospectus for more information.
Our
common stock trades on the Nasdaq Capital Market under the symbol “SHPH.” On March 11, 2025, the last reported sale
price of our common stock was $0.42 per share.
We
have retained WestPark Capital, Inc. as the exclusive underwriter with respect to this offering (the “Underwriter”). We have
agreed to pay the underwriter fees totalling 4.0% of the aggregate gross cash proceeds actually realized by the Company from the
sale of the shares being offered hereby. See “Underwriting” beginning on page 42 of this prospectus for more information
regarding these arrangements.
You
should read this prospectus, together with additional information described under the heading “Where You Can Find More Information,” carefully before you invest in any of our securities.
We
are an “emerging growth company” as defined in Section 2(a) of the Securities Act of 1933, as amended (the “Securities
Act”), and we have elected to comply with certain reduced public company reporting requirements.
You should read this prospectus, together
with the additional information described under the headings “Where You Can Find More Information” and “Incorporation
of Documents by Reference,” carefully before you invest in any of our securities.
An
investment in our securities involves significant risks. You should carefully consider the risk factors beginning on page 13 of this
prospectus and in documents incorporated by reference into this prospectus before you make your decision to invest in our securities.
Neither
the Securities and Exchange Commission, or the SEC, nor any state securities commission has approved or disapproved of these securities
or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
| |
Per Share | | |
Per Pre-Funded Warrant | | |
Total | |
Public offering price | |
$ | 0.30 | | |
| 0.299 | | |
$ | 5,750,000 | |
Underwriting discounts
and commissions(1) | |
$ | 0.012 | | |
| 0.012 | | |
$ | 230,000 | |
Proceeds to us, before expenses | |
$ | 0.288 | | |
| 0.28704 | | |
$ | 5,502,888 | |
(1) |
We
have agreed to pay the Underwriter a cash fee.
In addition, we have agreed to reimburse the Underwriter for certain offering-related
expenses. We refer you to “Underwriting” beginning on page 42 for additional
information regarding compensation to be received by the Underwriter. |
Delivery
of the shares and Pre-Funded Warrants is expected to be made on or about March 12, 2025, subject to satisfaction of customary
closing conditions.
WestPark
Capital, Inc.
The
date of this prospectus is March 12, 2025
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
We
incorporate by reference important information into this prospectus. You may obtain the information incorporated by reference without
charge by following the instructions under “Where You Can Find More Information.” You should carefully read this prospectus
as well as additional information described under “Incorporation of Documents by Reference” before deciding to invest in
our securities.
The
registration statement of which this prospectus forms a part and which we filed with the Securities and Exchange Commission (the “SEC”)
includes exhibits that provide more detail of the matters discussed in this prospectus. You should read this prospectus and the related
exhibits filed with the SEC, together with the additional information described under the heading “Where You Can Find More Information”
before making your investment decision. You should rely only on the information provided in this prospectus or incorporated
by reference in this prospectus, in any prospectus supplement or in a related free writing prospectus, or documents to which we otherwise
refer you. In addition, this prospectus contains summaries of certain provisions contained in some of the documents described herein,
but reference is made to the actual documents for complete information.
This
prospectus includes important information about us, the securities being offered and other information you should know before investing
in our securities. You should not assume that the information contained in this prospectus or incorporated by reference in this prospectus
is accurate on any date subsequent to the date set forth on the front cover of this prospectus, even though this prospectus is delivered
or securities are sold or otherwise disposed of on a later date. It is important for you to read and consider all information contained
in this prospectus in making your investment decision. All of the summaries in this prospectus are qualified in their entirety by the
actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference
as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described
below under the heading “Where You Can Find More Information.”
We
have not, and the Underwriter has not, authorized anyone to provide any information or to make any representations other than those contained
in this prospectus, or incorporated by reference in this prospect, or in any free writing prospectuses prepared by or on behalf
of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other
information that others may give you. The information contained in this prospectus or incorporate by reference in this prospectus
or contained in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any
sale of our securities. Our business, financial condition, results of operations and prospects may have changed since that date.
For
investors outside the United States: We have not done anything that would permit a public offering of the securities or possession or
distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons
outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating
to, the offering of the securities and the distribution of this prospectus outside of the United States. You are required to inform yourselves
about and to observe any restrictions relating to this offering and the distribution of this prospectus outside of the United States.
You
should rely only on the information contained in this prospectus or incorporated by reference in this prospectus, and in any free
writing prospectus prepared by or on behalf of us. We have not authorized anyone to provide you with information different from, or in
addition to, that contained in this prospectus or incorporated by reference herein and therein, or any related free writing prospectus.
This prospectus is an offer to sell only the securities offered hereby but only under circumstances and in jurisdictions where it is
lawful to do so. The information contained in this prospectus and in documents incorporated by reference is current only as of
its date. Our business, financial condition, results of operations and prospects may have changed since that date.
We
are not offering to sell or seeking offers to purchase these securities in any jurisdiction where the offer or sale is not permitted.
We have not done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where
action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this
prospectus and any free writing prospectus related to this offering in jurisdictions outside the United States are required to inform
themselves about and to observe any restrictions relating to this offering and the distribution of this prospectus and any such free
writing prospectus applicable to that jurisdiction.
Unless the context otherwise requires, references
in this prospectus to “Shuttle Pharma,” “Shuttle Pharmaceuticals,” “the Company,” “we,”
“our” and “us” refers to Shuttle Pharmaceuticals Holdings, Inc. and its subsidiaries, Shuttle Pharmaceuticals,
Inc. and Shuttle Diagnostics, Inc.
Industry
and Market Data
Unless
otherwise indicated, information contained in this prospectus or incorporated by reference in this prospectus concerning our industry
and the markets in which we operate or plan to operate, including our general expectations and market position, market opportunity and
market share, is based on information from our own management estimates and research, as well as from industry and general publications
and research, surveys and studies conducted by third parties. Management estimates are derived from publicly available information, our
knowledge of our industry, and assumptions based on such information and knowledge which we believe to be reasonable. Our management
estimates have not been verified by any independent source, and we have not independently verified any third-party information. In addition,
assumptions and estimates of our company’s and our industry’s future performance are necessarily subject to a high degree
of uncertainty and risk due to a variety of factors, including those described in the section entitled “Risk Factors” beginning
on page 13. These and other factors could cause our future performance to differ materially from our assumptions and estimates.
See “Special Note Regarding Forward-Looking Statements” on page 17 below.
Basis
of Presentation
On
August 6, 2024, we filed a Certificate of Amendment to our certificate of incorporation with the Secretary of State of the State
of Delaware to effect a 1-for-8 reverse stock split of our issued and outstanding shares of common stock, par value $0.00001 per share
(the “2024 Reverse Stock Split”), which became effective on August 13, 2024. All historical share and per share amounts reflected
throughout this prospectus have been adjusted to reflect the 2024 Reverse Stock Split. However, our periodic and current reports, and
all other documents that were filed prior to August 13, 2024, do not give effect to the 2024 Reverse Stock Split.
PROSPECTUS
SUMMARY
This
summary highlights information contained in greater detail elsewhere in this prospectus or information incorporated by reference in
this prospectus from our filings with the SEC. This summary is not complete and does not contain all of the information you should
consider in making your investment decision. You should read the entire prospectus and the documents incorporated by reference into
this prospectus carefully before making an investment in our securities. You should carefully consider, among other things, our financial
statements and the related notes and the sections entitled “Risk Factors” included elsewhere in this prospectus and in
the documents incorporated by reference into this prospectus.
Overview
Shuttle
Pharma is a clinical stage pharmaceutical company leveraging our proprietary technology to develop novel therapies designed to cure
cancers. Our goal is to extend the benefits of cancer treatments with surgery, radiation therapy, chemotherapy and immunotherapy.
Radiation therapy (“radiation therapy” or “RT”) is one of the most effective modalities for treating
cancers. We are developing a pipeline of products designed to address the limitations of the current cancer therapies as well as to
extend to the new applications of RT. We believe that our product candidates will enable us to deliver cancer treatments that are
safer, more reliable and at a greater scale than that of the current standard of care.

The
corporate structure is based on Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq SHPH – a Delaware Company) with drug discovery and
development performed in the wholly owned Shuttle Pharmaceuticals, Inc. (a Maryland Company) and diagnostics performed in the wholly
owned Shuttle Diagnostics, Inc. (a Maryland Company). Our product candidates include Ropidoxuridine, a Phase II, clinical-stage radiation
sensitizer, a platform of HDAC inhibitors (SP-1-161, SP-2-225 and SP-1-303) and two preclinical, prostate cancer-oriented diagnostics
assets – the PC-RAD Test, a blood test to predict clinical response to radiation therapy and the PSMA-B ligand for potential use
as a theranostic agent.
In
December 2023, we submitted an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”)
to support the next phase of development of Ropidoxuridine. In January 2024, we received the ‘Safe to Proceed’ letter from
the FDA for our IND application for the 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 us to commence
the Phase II study of Ropidoxuridine (IPdR). Sixteen patients have enrolled in the study as of February 20, 2025 and half of those patients
have now completed all seven courses of treatment with Ropidoxuridine. We have applied for and received FDA approval of “orphan”
designation for Ropidoxuridine and RT for treating brain cancer (glioblastoma). The Phase II clinical trial was also approved by
the Institutional Review Board (“IRB”) on June 21, 2024. We believe our management team’s expertise in radiation
therapy, combined modality cancer treatment and immuno-oncology will help drive the development and, if approved, the commercialization
of these potentially curative therapies for patients with aggressive cancers.
Radiation
Oncology has gone through transformative technological innovation over the last decade to better define tumors, allow improved shaping
of radiation delivery and support dose escalation with shorter, more intensive courses of treatment. Furthermore, achieving higher dose
distributions within tumor volumes has reached a practical plateau, since cancers are frequently integrated with or surrounded by more
sensitive normal tissues and further dose escalation increases risks of tissue necrosis. To increase cancer cures at maximally tolerated
radiation doses, pharmacological and biological modifications of cells are needed to sensitize cancers, protect normal tissues, and stimulate
the immune system to react against antigens produced by irradiated, damaged cancer cells. Drugs that show sensitizing properties, or
the ability to make cancer cells more sensitive to radiation, offer a solution to this problem. Currently, such drugs are chemotherapy
agents used off-label, and many have inherent toxicities since they were designed for direct cancer treatments and not for sensitization.
However, the clinical value of using radiation sensitizing drugs in combination with RT has been accepted in a variety of cancer types,
including gynecological, gastro-intestinal, pulmonary and other malignancies. Hence, there is a critical need for new drugs that preferentially
sensitize cancer cells to radiation therapy and that stimulate the innate immune response against irradiated cancer cells. Furthermore,
to advance precision medicine in radiation oncology, there is a need for imaging and molecular diagnostic tests for determining the extent
of cancer spread in the body and for predicting clinical responses to therapy.
We
are developing our products with the goal of addressing the unmet need in cancer treatment for a commercially marketable radiation response
modifier solution that leads to greater sensitivity of cancer cells to ionizing radiation therapy. The goal of our products is to increase
the therapeutic index for patients receiving radiation and to decrease radiation-related toxicities in patients with solid tumors. Our
products operate across three areas related to the treatment of cancer with RT:
|
1. |
Sensitization
of growing cancer cells, rendering them more susceptible to the effects of radiation therapy. |
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|
|
|
2. |
Activation
of the DNA damage response pathway to kill cancer cells and protect adjacent normal cells. |
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|
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|
3. |
Activation
of the immune system to kill any remaining cells after RT. |
Our
platform technology allows for the creation of an inventory of products for radiation sensitizing, immune modulation, and protection
of healthy tissue.
Operations
to date have focused on continuing our research and development efforts to advance Ropidoxuridine clinical testing and improved drug
formulation, to advance HDAC6 inhibitor (SP-2-225) preclinical development and explore application of the PC-RAD Test, predictive biomarkers
of radiation response. The clinical development of Ropidoxuridine has included completion of a Phase I clinical trial to establish drug
bioavailability and a maximum tolerated dose for use in Phase II clinical trials. TCG GreenChem, Inc. (“TCG GreenChem”),
with whom we have contracted for process research, development and cGMP compliant manufacture of IPdR, has manufactured the active pharmaceutical
ingredient (API) of Ropidoxuridine and the University of Iowa Pharmaceuticals has formulated the drug product for use in the Company’s
upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy. The drug product (capsules) were shipped to contract
research organization (“CRO”) Theradex Oncology and distributed to clinical trial sites that are fully approved to
enroll patients in the trial. Shuttle received approval from the FDA to begin the clinical trial. The FDA made recommendations to expand
the clinical trial to include a randomized dose “optimization” step and we agreed with the recommendation. Meetings with
engaged clinical sites to review the protocol documents have occurred and FDA required IRB approvals have
been received. With FDA recommended changes incorporated into the revised protocol and the completion of site initiation visits, the
Company has commenced its Phase II clinical study. The radiation biomarker project and the health disparities project have been completed
and the Company is proceeding with plans for clinical validation and potential for commercialization of Ropidoxuridine as a radiation
sensitizer.
Our
Pipeline
We
are currently developing a pipeline of small molecule radiation sensitizers and immune response regulating drugs. Our most advanced product
candidate is Ropidoxuridine, an orally available halogenated pyrimidine with strong cancer radiation sensitizing properties is in preclinical
studies. In addition, we have a pipeline of complimentary product candidates that we are developing to address solid tumor cancer indications
by radiation sensitization or immune modification. Our therapeutic pipeline is represented in the diagram below:

Timeline
for clinical phase (Ropidoxuridine) and pre-clinical phase (HDAC inhibitors) pipeline.
Our
lead product candidates include:
|
● |
Ropidoxuridine
(IPdR) is our lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma) and
sarcomas. Phase I clinical trial results supported by a National Institutes of Health, or NIH contract to Shuttle Pharma and the
NCI (CTEP) were reported in the medical journal, Clinical Cancer Research, in July 2019, by our Small Business Innovation Research,
or SBIR, subcontractor. Eighteen patients completed dose escalations to 1,800 mg/day for 30 days, establishing the maximum tolerated
dose (MTD) of 1,200 mg/day in combination with RT. Four partial responses, nine stable disease and one progressive disease in target
lesions were reported. Four patients did not have measurable disease and, as a result, were not evaluable. These Phase I trial results
demonstrate oral bioavailability and an MTD of 1,200 mg per day for 28 days for use in combination with radiation for Phase II clinical
trials that we propose to perform in brain tumors and in sarcomas. The brain tumor, glioblastoma multiforme (GB) is eligible for
“orphan” disease designations. Shuttle Pharma has advanced drug manufacture and formulation and prepared a clinical
protocol of a “Phase 2 Single-Arm Study of IPdR as a Radiation Sensitizing Agent During Radiotherapy in Patients with Newly
Diagnosed IDH-Wildtype MGMT Unmethylated Glioblastoma Multiforme.” In December 2023, we submitted an IND application with the
FDA to support the next phase of development of Ropidoxuridine. In January 2024, we received the ‘Safe to Proceed’ letter
from the FDA for our IND application for the 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 us to commence
the Phase II study of Ropidoxuridine (IPdR). The clinical development of Ropidoxuridine has shown drug bioavailability and a maximum
tolerated dose has been established for use in Phase II clinical trials. TCG GreenChem, with whom we have contracted for process
research, development and cGMP compliant manufacture of IPdR, has successfully completed the 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 also worked with University of Iowa Pharmaceuticals to develop the formulation and
produce the capsules, which have been shipped to CRO Theradex Oncology for distribution to clinical trial sites. Both activities
have now been completed. In addition, Shuttle received approval from the FDA to begin the clinical trial. The FDA made recommendations
that led to an expanded clinical trial to include randomized dose optimization and we agreed with the recommendation. We met with
representatives from six candidate clinical sites to review the protocol documents and FDA required IRB approvals have been obtained.
With FDA recommended changes incorporated into the revised protocol, the Company has now contractually engaged all six of the planned
research centers which have begun performing clinical trials in our Phase II clinical study. Sixteen patients have enrolled
in the study as of February 20, 2025 and half of those patients have already completed all seven courses of treatment with
Ropidoxuridine. |
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● |
The
Phase II clinical study is summarized below:

|
Schema
for the Phase II clinical trial. The initial cohort of 40 patients will be randomized to one of two Ropidoxuridine doses. 20 patients
will receive the 1200 mg dose and 20 patients will receive the 960 mg dose. The optimum dose will be determined by comparing drug bioavailability
and side-effects. The optimum dose will then continue to enroll 14 additional patients to provide the required 34 patients for statistical
significance in comparison to historical controls.
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● |
Ropidoxuridine
and Tipiracil (IPdR/TPI) is a new combination formulation demonstrating extended bioavailability after oral administration
in an animal model system. The IPdR/TPI formulation will undergo preclinical development for use as a radiation sensitizer and represents
a “next generation” drug product for clinical evaluation. |
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● |
SP-2-225
is Shuttle Pharma’s pre-clinical class IIb selective HDAC inhibitor that affects histone deacetylase HDAC6 has been
identified as the candidate lead molecule for development as a post-RT innate immune system activator. The macrophage is a key target
for activating the innate immune system against cancer cells. SP-2-225 has effects on the regulation of the immune system by maintaining
macrophage cells in an inflammatory, anti-cancer polarization. The interactions of RT with the immune response for cancer treatment
are of great current interest, offering insight into potential mechanisms for primary site and metastatic cancer treatment. For this
reason, Shuttle Pharma has selected SP-2-225 as the candidate lead HDAC inhibitor for preclinical development. We have contracted
with investigators at Georgetown University to perform preclinical studies of immune activation after radiation therapy in an animal
tumor model. These data have been published (Noonepalle SKR, Grindrod S, Aghdam N, Li X, Gracia-Hernandez M, Zevallos-Delgado C,
Jung M, Villagra A, Dritschilo A. Radiotherapy-induced Immune Response Enhanced by Selective HDAC6 Inhibition. Mol Cancer Ther. 2023
Dec 1;22(12):1376-1389. doi: 10.1158/1535-7163.MCT-23-0215. PMID: 37586844; PMCID: PMC10878032) and additional preclinical studies
are in progress with our contractors. With the introduction of check-point inhibitors, CAR-T therapies and personalized medicine
in cancer, regulation of the immune response following RT is of significant clinical and commercial interest. |
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● |
SP-1-303
is Shuttle Pharma’s pre-clinical selective Class I HDAC inhibitor that preferentially affects histone deacetylases
HDAC1 and HDAC3 members of the class I HDAC family of enzymes. SP-1-303 data show direct cellular toxicity in ER positive breast
cancer cells. Furthermore, SP-1-303 increases PD-L1 expression. Completed preclinical in vitro studies have been published (Jung
M, Nicholas N, Grindrod S, Dritschilo A. Dual-targeting class I HDAC inhibitor and ATM activator, SP-1-303, preferentially inhibits
estrogen receptor positive breast cancer cell growth. PLoS One. 2024 Jul 15;19(7):e0306168. doi: 10.1371/journal.pone.0306168. PMID:
39008483; PMCID: PMC11249239.). We plan to seek university collaborations to complete SP-1-303 pre-clinical development in 2024. |
Our
Approach
We
believe that we have established a leadership position in radiation sensitizer and response modifier discovery and development. We have
identified a clinical phase product candidate and discovered new pre-clinical phase molecules using our proprietary platform technologies
to increase the therapeutic index for patients receiving radiation for treatment of solid tumors. Our development strategy has four key
pillars: (1) to improve the efficacy of RT by demonstrating improved disease-free survival rates in patients who undergo radiation therapy,
(2) reduce the amount of radiation needed for a favorable tumor response, thereby limiting the potential for radiation related toxicities
to healthy cells, (3) decrease the extent of surgery needed to remove cancers and improve quality of life, and (4) leverage our next
generation technologies to create drugs that regulate the immune response assisting immune checkpoint and CAR-T therapies and other personalized
medicines targeting cancers.
In
addition to private and public investment into our candidate therapeutic technology, we have also competed for non-dilutive funding from
the NIH to support our lead sensitizer and to explore development of complimentary diagnostic products. To date, we have completed three
SBIR contracts awarded to Shuttle Pharma by the NIH to:
|
● |
Develop
IPdR as a radiation sensitizer. This funding provided partial support for the Phase I clinical trial of Ropidoxuridine and RT. |
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● |
Develop
prostate cancer cell cultures from African-American men, with donor matched normal prostate cells, establishing 50 pairs for accelerating
research to reduce prostate cancer health disparities in African-American men. This project was funded under “Moonshot”
designation. Shuttle Pharma is eligible to apply for additional SBIR (Phase IIb) funding to commercialize these cells for research
purposes. Currently, cells from African-American patients are distributed, on request, to investigators who are conducting health
disparities research. We plan to test new small molecules using these cellular reagents for health disparities screening. |
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● |
Develop
a predictive biomarker for determining outcomes for prostate cancer patients following treatment with RT. This SBIR-funded project
for blood test (PC-RAD Test) discovery and analytical validation were completed on March 15, 2022, and Shuttle Pharma intends to
perform a clinical validation study. Shuttle Pharma has licensed the intellectual property for the prostate cancer predictive biomarker
test from Georgetown University and will seek additional investment from the public market to advance clinical development through
its Shuttle Diagnostics entity. |
All
three SBIR funded projects have been completed. The Company is eligible to apply for SBIR Phase IIb funding to advance the “Moonshot”
health disparities or the predictive biomarker project. The NIH SBIR program is designed to encourage small businesses to engage in Federal
Research/Research and Development (“R/R&D”) that has the potential for commercialization.
Shuttle
Pharma’s scientists have also developed collaborations to invent intellectual properties for prostate cancer theranostics. From
a clinical perspective, prostate-specific membrane antigen (PSMA) is a valuable target for diagnosis and therapy of prostate cancer.
In a discovery project to develop a novel, boron-containing PSMA ligand to enhance proton radiation therapy of prostate cancer, we discovered
PSMA-B, a molecule containing boron and demonstrating nanomolar binding activity to PSMA. Preclinical evaluations have been initiated
to explore the PSMA-B ligand as a potential prostate cancer sensitizer in combination with proton therapy, as well as a PET diagnostic
reagent and as a targeted prostate cancer therapeutic. By in-licensing our collaborator’s shares of the intellectual property,
Shuttle Pharma has an exclusive license to the PSMA-B intellectual property and has filed a patent application. Theranostic molecules
are suitable for diagnosis and therapy of cancers. The PSMA ligand is a molecule that binds to the PSMA, an enzyme that is highly expressed
in prostate cancer cells. The PSMA ligand is currently used for imaging and therapy to detect and treat prostate cancer.
|
● | Develop
PSMA-B as a potential diagnostic and therapeutic molecule in pre-clinical models in collaboration
with academic nuclear medicine programs. Shuttle Pharma has licensed the intellectual property
for the prostate cancer predictive biomarker test from inventors and will seek additional
investment from NIH by applying for grant applications and from the public market to advance
pre-clinical development through its Shuttle Diagnostics entity. |
Our
Strategy
Our
goal is to maintain and build upon our leadership position in radiation sensitization. We plan to develop Ropidoxuridine and the HDAC6
inhibitor (SP-2-225) and, if approved by the FDA, commercialize our product candidates for the treatment of cancers. While this process
may require years to complete, we believe achieving this goal could result in new radiation sensitizer and immunotherapy products. Key
elements of our strategy include:
|
● |
Capitalize
on Ropidoxuridine as an orally available, small molecule radiation sensitizer. To date, there is one drug (Cetuximab, a monoclonal
antibody) approved by the FDA specifically as a radiation sensitizer. If we are successful in developing Ropidoxuridine and obtaining
FDA approval, a small molecule sensitizer would then be enabled for clinical applications for radiation sensitization indications. |
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|
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|
● |
Expand
our leadership position within radiation sensitizers. In addition to our traditional radiation sensitizers, we plan to advance
our near-term pipeline to include radiation sensitizers for proton therapy. Proton Therapy is growing worldwide as a form of radiation
therapy due to its unique beam shaping characteristics. As a result, this new technology offers a major opportunity for Shuttle Pharma
to strive to develop an innovative and well-tolerated drug for proton therapy sensitization. |
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● |
Execute
a disciplined business development strategy to strengthen our portfolio of product candidates. We have built our current product
pipeline through in-house discovery, development, partnerships with leading academic institutions and through in-licensing. We will
continue to evaluate new in-licensing opportunities and collaboration agreements with leading academic institutions and other biotechnology
companies around programs that seek to address areas of high unmet need and for which we believe there is a high probability of clinical
success, including programs beyond our target franchise areas and current technology footprint. |
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● |
Invest
in our HDAC platform technology and maximize its utility across cancer therapies. We are initially applying the platform to develop
drugs for cancer radiation sensitization, normal tissue radiation protection and post radiation immune stimulation. Based on the
data we have obtained thus far, these drugs are immune regulatory. We intend to invest to develop other properties of our platform
technology, as well. |
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● |
Enter
into collaborations to realize the full potential of our platform. The breadth of our HDAC technology platform enables other
therapeutic applications, including radiation sensitization and immune therapy. We intend to seek collaborations centered on our
platform to maximize applications for cancer treatment. |
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● |
Establish
Shuttle Diagnostics, Inc. as a subsidiary of SHPH in order to advance development of the predictive biomarker (PC-RAD
Test) and the PSMA ligand (PSMA-B) to advance prostate cancer treatment. |
Management
Team
Our
management team has significant experience in radiation oncology and in progressing products from early-stage research through clinical
trials. Our Chief Executive Officer, or CEO, Anatoly Dritschilo, M.D., is an experienced clinician and researcher who has held senior
academic and management positions including serving as Department Chairman, Hospital Medical Director and Cancer Center Director at Georgetown
University Medical Center. Prior to co-founding our Company, Dr. Dritschilo was a co-founder of Oncomed, Inc., a company that became
public as NeoPharm, Inc. (Nasdaq: NEOL). He has experience in providing care for patients undergoing treatment for cancers of the prostate,
breast, brain, lung, sarcomas and GI systems. Dr. Dritschilo has directed basic science research supported by grants from the National
Cancer Institute (“NCI”) and performed clinical trials using drugs and radiation therapy. In addition, Dr. Dritschilo served
as the principal investigator of pharmaceutical industry sponsored clinical evaluations of human interferon alpha-2 (Bristol-Myers) with
radiation therapy and antisense raf oligonucleotides, LErafAON (NeoPharm) with radiation therapy. He serves as a Radiation Biology and
Radiation Oncology expert on committees of the NIH to review Program Project (P01) grant applications, Specialized Program of Research
Excellence (SPORE) grant applications and investigator-initiated research project (R01) applications.
Dr.
Dritschilo is supported in our clinical development effort by Tyvin Rich, MD, our Chief Clinical Officer and Medical Director. Dr. Rich
is the former Professor and Chairman of the Department of Therapeutic Radiology and Oncology at the University of Virginia Health Sciences
Center and proton radiation therapy specialist at the Hampton Proton Therapy Center in Hampton, Virginia. Dr. Rich has served as principal
investigator on multi-modality clinical trials for the treatment of gastrointestinal (GI) cancers and helped to develop treatment with
5-fluorouracil (5-FU) as a radiation sensitizer for use with RT in the treatment of GI cancers. He has extensive cancer clinical trial
experience in developing radiation sensitizer applications through his participation in the Radiation Therapy Oncology Group (RTOG).
Dr. Rich is a co-inventor with scientists at the University of Virginia of the Proton Activated Atomic Medicine technology.
Our
administrative services are provided by Peter Dritschilo, MBA, who has served as our President and COO since 2012. Mr. Dritschilo’s
experience in hospital administration and management of medical oncology clinical services and radiation therapy facilities, including
management of day-to-day operations, human resources and financial oversight. Peter Dritschilo is the son of our Chairman and CEO, Dr.
Anatoly Dritschilo. Mr. Timothy J. Lorber is our Chief Financial Officer, or CFO, a position he
has served in since June 2024. Mr. Lorber is a CPA with more than 40 years of professional finance experience. We believe his extensive
experience and expertise in the financial industry supports his service as our CFO. Michael Vander Hoek, our former CFO, as Vice
President for Operations and Regulatory expands our capability to provide the level of management needed for the proposed expansion of
clinical trials. Mr. Vander Hoek served as administrative director of the Lombardi Comprehensive Cancer Center (LCC) for 12 years and
has extensive experience in negotiations, management and supervision of CROs and research contracts
in general. As the administrative director of the Lombardi Comprehensive Cancer Center, Mr. Vander Hoek also served as the chief financial
officer. Taken together, we believe our leadership team of highly qualified specialists will help us achieve the proposed milestones
for the development of radiation sensitizer products.
Nasdaq
Deficiency
Our
common stock currently is listed for quotation on the Nasdaq Capital Market. We are required to meet Nasdaq listing rules in order to
maintain such listing, including a requirement that the Company’s stockholders equity remain at or above $2.5 million.
On
September 10, 2024, we received a letter from The Nasdaq notifying the Company that it is no longer in compliance with the minimum stockholders’
equity requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires listed companies to maintain
stockholders’ equity of at least $2.5 million. In the Company’s Quarterly Report on Form 10-Q for the period ended June 30,
2024, the Company reported stockholders’ equity of $801,434, which is below the minimum stockholders’ equity required for
continued listing pursuant to Nasdaq Listing Rule 5550(b)(1). In addition, at present, the Company does not meet the alternatives of
market value of listed securities or net income from continuing operations.
This
Nasdaq notice had no immediate effect on the listing of the Company’s securities on the Nasdaq Capital Market. The Company
subsequently submitted a revised plan of compliance to Nasdaq on November 14, 2024. The Company’s plan to regain compliance was
accepted, and Nasdaq granted an extension of 180 calendar days from September 10, 2024, or until March 10, 2025, for the Company
to regain compliance. Following closing of this Offering, the Company believes it has regained compliance with the Nasdaq minimum
stockholders’ equity requirement. However, such compliance will be subject to ongoing monitoring by Nasdaq, including the requirement
that our stockholders’ equity exceeds $2.5 million in our Quarterly Report on From 10-Q for the period ending March 31, 2025.
On
December 31, 2024, the Company, received a letter from The Nasdaq stating that for the 30 consecutive business day period between November
15, 2024 to December 30, 2024 the Company’s common stock had failed to maintain a minimum closing bid price of $1.00 per share,
as required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price
Requirement”). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has an initial period of 180 calendar days, or until
June 30, 2025 (the “Compliance Period”), to regain compliance with the Minimum Bid Price Requirement. To regain compliance,
the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business
days.
There
can be no assurance that the Company will be able to regain compliance and maintain its listing on the Nasdaq Capital Market. If
the Company fails to satisfy another Nasdaq requirement for continued listing, Nasdaq could provide notice that the Company’s securities
will become subject to delisting. In such event, the Company will have an opportunity to appeal Nasdaq’s decision to a hearings
panel.
2024
Reverse Stock Split
On
August 31, 2023 we received a letter from the Nasdaq Listing Qualifications Staff of the Nasdaq (the “Staff”) stating that
for the 30 consecutive business day period the Company’s common stock had failed to maintain a minimum closing bid price of $1.00
per share, as required for continued listing on The Nasdaq Capital Market pursuant to the Minimum Bid Price Requirement.
In
order to regain compliance with the Minimum Bid Price Requirement, on August 6, 2024, we filed an amendment to our certificate of incorporation
to effect the 2024 Reverse Stock Split. The 2024 Reverse
Stock Split became effective on August 13, 2024, when the Company’s common stock opened for trading on Nasdaq on a post-split basis
under the Company’s existing trading symbol, “SHPH.” Subsequently, on August 27, 2024, we received notice from Nasdaq
that we regained compliance with the Minimum Bid Price Requirement.
All
historical share and per share amounts reflected throughout this prospectus have been adjusted to reflect the 2024 Reverse Stock Split.
However, our periodic and current reports, and all other documents that were filed prior
to August 13, 2024 do not give effect to the 2024 Reverse Stock Split.
Going
Concern Uncertainty
Our consolidated financial
statements are prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and
commitments in the normal course of business. The Company has not generated any revenues, incurred losses since inception and has a net loss of approximately
$9.1 million and no revenues for the fiscal year ended December 31, 2024 and has working capital of approximately
$0.7 million as of December 31, 2024.
The Company does not
expect to generate positive cash flows from operating activities in the near future.
In September 2024,
the Company’s CEO provided $250 thousand to the Company in exchange for a promissory note repayable in equal monthly
installments of principal and interest over a term of one year. In October 2024, the Company completed an offering of senior secured
convertible bridge notes, receiving $790 thousand in cash. The notes have a term of one-year and were accompanied by 329,461
warrants with a weighted-average exercise price of $1.42 per share. Also in October 2024, the Company completed an equity
raise that provided $3.7 million net cash for the issuance of 2.9 million shares of common stock, or pre-funded
warrants in lieu thereof, and 2.9 million warrants with an exercise price of $1.40 per share. Refer to the “Recent Financings” section below for additional information. However, the
Company’s existing cash resources and the cash received from the equity offering and senior convertible note are not expected
to provide sufficient funds to carry out the Company’s operations and clinical trials through the next twelve months.
The Company’s capital
raises have to date supported operations, the manufacture of drug product and FDA approval of the IND for the Phase II clinical trial
of Ropidoxuridine and radiation therapy in glioblastoma and other radiation sensitizer discovery and therapy. The FDA recommended and
the Company agreed to an expansion of the Phase II clinical trial, necessitating additional capital to complete the trial as well as
fund ongoing operations. Additionally, the Phase II clinical trial of Ropidoxuridine has evolved with finalized agreements with all six
of the planned site enrollment locations to administer the Phase II clinical trial of Ropidoxuridine and enrollment of 16 patients as of the date of this prospectus.
The ability of the Company to continue as a going
concern is dependent upon its ability to continue to successfully raise additional equity or debt financing to allow it to fund
ongoing operations, conduct clinical trials and bring a drug candidate to commercialization to generate revenues. These conditions raise
substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued.
If
we fail to obtain additional material financing in the near-term, our clinical trials and targeted FDA submission timeline could be delayed,
and we could be forced to abandon such activities entirely and cease operations, with the possible loss of such properties or assets.
If we are unable to obtain a material quantum of financing in the imminent future or unable to continue to obtain additional financing
over at least the next 12 months as we continue to generate negative cash flow, our board of directors could determine to cause the Company
to undertake a process of liquidation under Chapter 7 of applicable U.S. bankruptcy laws, or otherwise seek other protection under such
laws. In such event, we expect that holders of shares of our common stock would recoup little if
any material value in such process.
Recent
Financings
On
January 11, 2023, we entered into a securities purchase agreement (the “January 2023 SPA”) with Alto Opportunity Master
Fund, SPC – Segregated Master Portfolio B, a Cayman entity (the “January 2023 Investor”), as amended on May
10, 2023 and June 4, 2023, pursuant to which the Company sold to the January 2023 Investor a $4.3 million convertible note (the
“January 2023 Convertible Note”) and warrant (the “January 2023 Warrant”) to purchase 127,260 (post Reverse Split)
shares of common stock of the Company, in exchange for gross proceeds of $4.0 million (the “Investment Amount”). The January
2023 Convertible Note amortizes on a monthly basis and the Company can make such monthly amortization payments in cash or, subject to
certain equity conditions, in registered shares of common stock or a combination thereof. For equity repayment, the January 2023 Convertible
Note is convertible into shares of common stock at price per share equal to the lower of (i) $18.8 (post Reverse Split) (ii) 90% of the
three lowest daily volume-weighted average price (“VWAP”) of the 15 trading days prior to the payment date or (iii)
90% of the VWAP of the trading day prior to payment date. The January 2023 Convertible Note is repayable over 26 months and bears interest
at the rate of 5% per annum. The January 2023 Warrant is exercisable for four years from the date of closing and is exercisable at $0.48
per share (post Reverse Split, and as subsequently adjusted pursuant to the January 2023 SPA, as amended). In the event the January
2023 Investor exercises the January 2023 Warrant in full, such exercise would result in additional gross proceeds to the Company
of approximately $61 thousand. As of September 30, 2024, the January 2023 Convertible Note has been paid in full.
On
September 4, 2024, the Company entered into a loan agreement with our Chief Executive Officer, Dr. Anatoly Dritschilo, pursuant to which
Dr. Dritschilo loaned the Company $250,000 (principal), bearing interest at the rate of 12% per annum and which is repayable in 12 substantially
equal monthly installments over a one year period.
On October 14, 2024, the Company issued an aggregate
of $600,000 (of an up to $1.3 million authorized financing) senior secured convertible notes due in October 2025, which accrue interest
at 14.5% interest per year. The notes include a 5% original issue discount and the Company received $570,000 in proceeds. The notes are
convertible beginning three months after the date of issuance, and the conversion price will be the lower of a 15% discount to (i) the
5-day VWAP immediately prior to Closing or (ii) the price of any offering entered into by the Company during the term of the notes. The
Company has the option to prepay the notes at any time for 107% of total outstanding balance and any outstanding principal will be paid
in conversion of shares of common stock at the end of the term, subject to the Company’s exercise of the optional prepayment right.
Any accrued interest will be repaid quarterly in cash. The Company also issued warrants to the lenders to purchase an aggregate 240,917
shares of common stock, exercisable at $1.40 per share, with such warrants expiring five years from issuance. In addition, the Company’s
Chief Executive Officer, Dr. Anatoly Dritschilo, invested a total of $237,500 in this financing round, in exchange for a $250,000 convertible
note.
On October 21, 2024, the Company issued an additional
$231,579 in senior secured convertible notes due in October 2025, with substantially similar terms as the October 14, 2024, issuance.
The notes include a 5% original issue discount and the Company received $220,000 in proceeds. The Company also issued warrants to the
lenders to purchase an aggregate 88,544 shares of common stock, exercisable at $1.49 per share, with such warrants expiring five years
from issuance. Upon completing this issuance, the Company closed the senior secured convertible note offering after receiving a total
of $790,000 in proceeds.
On
February 28, 2025, the Company entered into a Revolving Loan Agreement (the “Revolving Loan Agreement”) with Bowery Consulting Group Inc. (an entity for which Adam Chambers serves
as a Principal) (the “Lender”). Pursuant to and under the terms of the Revolving Loan
Agreement, the Company issued to the Lender a revolving note dated February 28, 2025, in the principal amount of $2,000,000 (the
“Revolving Note” and such amount, the “Maximum Outstanding Amount”), which the Company may draw upon at its
discretion from time to time (the “Financing”). Any drawdown on the Revolving Note bears interest at the rate of 18% per
annum calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, and shall accrue daily commencing on
the date of issuance until paid in full. Proceeds from any Financing may be used for general corporate purposes, including but not
limited to finance the expense of a Qualified Public Equity Offering (as defined below). The Underwriter served as financial advisor to the Company with regard
to the Financing. As financial advisor, the Underwriter received a fee of $20,000 following the signing of the Revolving Loan Agreement.
As financial advisor, the Underwriter will be entitled to receive a fee of four percent (4%) with regard to each draw down of the Revolving
Note. Out of the Maximum Outstanding Amount, the
Lender has not disbursed any loan amounts to date.
The
Revolving Loan Agreement contains customary events of default. If an event of default occurs, the Lender may accelerate the
indebtedness under the Revolving Loan Agreement, and an amount equal to 120% of the outstanding principal amount and accrued and
unpaid interest plus other amounts, costs, expenses and/or liquidated damages due under or in respect of the Loan Documents for the
Financing, if any. As a condition for the Lender entering into the Revolving Loan Agreement, on February 28, 2025 (i) each of Milton
Brown, Bette Jacobs, Chris Senanayake and Joshua Schafer resigned as directors of the Company, and (ii) the Company’s
remaining members of the Board of Directors appointed the following three people designated by the Lender as members of the Board of
Directors: George Scorsis, Joseph Tung and Oleh Nabyt. The resigning directors held 840,205 unvested
restricted stock units (“RSUs”) granted under the Company’s 2018 Equity Incentive Plan that became fully vested in
conjunction with their respective resignations on February 28, 2025. The
acceleration of these RSUs resulted in a compensation expense charge of $511,517.
Summary
Risk Factors
Our
business is subject to a number of risks you should be aware of before making an investment decision. These risks are discussed more
fully in the “Risk Factors” section of this prospectus at page 13 immediately following this prospectus summary,
and in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which
is incorporated by reference into this prospectus. These risks include the following:
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Our
ability to continue as a going concern in the near term is dependent upon us successfully raising additional equity or debt financing
to fund our operations. |
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Our
success is primarily dependent on achieving the development, regulatory approval and commercialization of our product candidates,
both of which are in the early stages of development. |
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Our
approach to the discovery and development of innovative radiation oncology drugs based on our HDAC small molecule delivery platform,
which is novel, unproven and may not result in marketable products. |
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We
have no product revenue, have incurred significant losses since inception, may never become profitable and may incur substantial
and increasing net losses for the foreseeable future as we continue the development of, and seek regulatory approvals for our product
candidates. |
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If
clinical trials of our product candidates fail to demonstrate safety and efficacy, which are ongoing determinations that are solely
within the authority of the FDA, we may be unable to obtain regulatory approvals to commercialize our product candidates. |
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We
are subject to regulatory approval processes that are lengthy, time-consuming and unpredictable. We may not obtain approval for any
of our product candidates from the FDA or foreign regulatory authorities. |
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Even
if we obtain regulatory approval, the market may not be receptive to our product candidates. |
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We
may not be able to establish collaborative partnerships with other pharmaceutical companies, through which we expect to complete
development of, obtain marketing approval for and, if approved, manufacture and market our product candidates. |
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We
may encounter difficulties satisfying the requirements of clinical trial protocols, including patient enrollment. |
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We
may face competition from other companies in our field or claims from third parties alleging infringement of their intellectual property. |
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We
may be unable to recruit or retain key employees, including our senior management team. |
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Any
drugs we develop may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform
initiatives, thereby harming our business. |
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We
are a Phase II clinical stage pharmaceutical company with a limited operating history upon which you can evaluate our business
and prospects. Specialty pharmaceutical product development is a highly speculative undertaking and involves a substantial degree
of risk. |
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We
do not currently have any product candidates in advanced clinical trials or approved for sale, and we continue to incur significant
research and development and general and administrative expenses in relation to our operations. In addition, we have not yet demonstrated
an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving
fields, particularly in the specialty pharmaceutical industry. |
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We
have not submitted an application or received marketing approval for any of our product candidates. Regulatory approval of our product
candidates is not guaranteed, and the approval process is expensive and may take several years. |
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It
is difficult and costly to protect our intellectual property rights. |
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If
we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. |
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On
September 4, 2024, we restated our annual report on Form 10-K for the year ended December 31, 2023, as a result of a re-audit of
our 2022 financial statements, and there may be some risk of regulatory, shareholder / investor or other actions or consequences
as a result of the restatement. |
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The
future issuance of equity or of debt securities that are convertible into common stock will
dilute our share capital.
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If
we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. |
Implications
of Being an Emerging Growth Company
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As a smaller reporting company,
and as a company with less than $1.235 billion in revenue during our last fiscal year, we qualify as an “emerging growth
company” as defined in the JOBS Act. For so long as we remain an emerging growth company, we are permitted and intend to rely
on exemptions from specified disclosure and other requirements that are applicable to other public companies that are not emerging
growth companies. These exemptions include: |
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being permitted to provide
only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly
reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure; |
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not being required to comply
with the auditor attestation requirements in the assessment of our internal control over financial reporting; |
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not
being required to comply with any mandatory audit firm rotation or a supplement to the auditor’s report providing additional
information about the audit and the financial statements; |
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reduced
disclosure obligations regarding executive compensation; and |
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exemptions
from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute
payments not previously approved. |
We
may take advantage of the above provisions for up to five years or until such earlier time that we are no longer an emerging growth company.
We would cease to be an emerging growth company if we have more than $1.235 billion in annual revenues, have more than $700 million in
market value of our capital stock held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period.
We may also choose to take advantage of some, but not all, of the available exemptions. We have taken advantage of some reduced reporting
requirements in this prospectus. Accordingly, the information contained in this prospectus or incorporated by reference in this prospectus
may be different than the information you receive from other public companies in which you hold stock.
In
addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with
new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards
until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended
transition period for adopting new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting
standards as other public companies that are not emerging growth companies.
Corporate
Information
The
Company was formed as a limited liability company in the state of Maryland in December 2012 and was converted to a C corporation in August
2016. In June 2018, Shuttle completed a share exchange with Shuttle Pharma Acquisition Corp. Inc. (“Acquisition Corp.”),
pursuant to which Shuttle Pharmaceuticals, Inc. became a subsidiary of Acquisition Corp. and we subsequently changed the name of Acquisition
Corp. to Shuttle Pharmaceuticals Holdings, Inc.
Our
executive offices are located at 401 Professional Drive, Suite 260, Gaithersburg, MD 20879 and our telephone number is (240)
430-4212. Our corporate website is www.shuttlepharma.com. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K, and all amendments to those reports, if any, are available to you free of charge through the “Investor Relations”
section of our website as soon as reasonably practicable after such materials have been electronically filed with or furnished to the
SEC. Information contained on our websites does not form a part of this prospectus.
THE
OFFERING
Common
stock we are offering: |
1,349,921
shares of common stock at a public offering
price of $0.30 per share of common stock. |
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Pre-Funded
Warrants to be offered: |
We
are also offering 17,825,746 Pre-Funded Warrants to purchase 17,825,746 shares of common stock in lieu of shares of common
stock to each purchaser whose purchase of shares of common stock in this offering would otherwise result in the purchaser, together with
its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our
outstanding common stock immediately following the consummation of this offering. The purchase price of each Pre-Funded Warrant will
equal the price at which one share of common stock is being sold to the public in this offering, minus $0.001, and the exercise price
of each Pre-Funded Warrant will be $0.001 per share. The Pre-Funded Warrants will be exercisable immediately and may be exercised at
any time until all of the Pre-Funded Warrants are exercised in full.
This
prospectus also relates to the offering of our common stock issuable upon exercise of the Pre-Funded Warrants. See “Description
of Securities We Are Offering – Pre-Funded Warrants.” |
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Common
stock outstanding before this offering: |
4,916,772
shares of common stock.(1) |
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Common
stock outstanding immediately after this offering: |
6,257,693
shares (assuming no exercise of Pre-Funded
Warrants sold in this offering). |
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Dividend
policy: |
We
have never paid cash dividends on our common stock and we do not anticipate paying any cash dividends in the foreseeable future.
See the section entitled “Dividend Policy.” |
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Use
of proceeds: |
We
estimate that the net proceeds from this offering will be approximately $5,200,000 million, after deducting
the cash fees to be paid to the Underwriter and estimated offering expenses payable by us. |
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We
intend to use the net proceeds from this offering to fund Phase II clinical trials for our lead product candidate radiation
sensitizer Ropidoxuridine, including $2.8 million in payments that will be owed to Theradex Systems, Inc., the CRO supporting
our Phase II clinical trials, along with up to $2.0 million for certain anticipated marketing fees. We anticipate that the
funds raised from this offering will allow us to make substantial progress with the Phase II clinical trial, but we will likely
require additional funds. See “Use of Proceeds” beginning on page 18 below. |
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Nasdaq
trading symbol: |
Our
common stock is listed on Nasdaq under the symbol “SHPH.” There is no established trading market for the Pre-Funded Warrants,
and we do not expect a market to develop. In addition, we do not intend to apply for the listing of the Pre-Funded Warrants on any
national securities exchange or nationally recognized trading system. Without an active trading market, the liquidity
of the Pre-Funded Warrants will be limited. |
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Risk
Factors: |
See
“Risk Factors” beginning on page 13 of this prospectus and other information included in this prospectus for a discussion
of the risk factors you should consider carefully when making an investment decision. |
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(1) |
The number of shares of our common
stock outstanding before this offering is based on 4,916,772 shares of our common stock outstanding
as of March 11, 2025, and, unless otherwise indicated, excludes, as of that date:
(i) 3,464,281 warrants to purchase common stock, exercisable at an average exercise price
of $1.89 per share; (ii) 1,826,000 pre-funded warrants issued in our October 2024 offering;
and (iii) 861,334 shares issuable under the convertible bridge notes issued in the
October 2024 Convertible Note Offering. |
RISK
FACTORS
An investment in our securities involves a
high degree of risk. Prior to making a decision about investing in our securities, you should carefully consider the risk factors described
below and the risk factors discussed in the sections entitled “Risk Factors” contained in our most recent Annual Report on
Form 10-K and Quarterly Reports on Form 10-Q, as may be amended, supplemented or superseded from time to time by other reports we file
with the SEC and incorporated by reference in this prospectus, together with all of the other information contained in this prospectus.
Additional risks and uncertainties not presently known to us, or that we currently view as immaterial, may also impair our business.
If any of the risks or uncertainties described in our SEC filings or this prospectus or any additional risks and uncertainties actually
occur, our business, financial condition and results of operations could be materially and adversely affected. In that case, the trading
price of our common stock could decline, and you might lose all or part of your investment.
Risks
Related to this Offering
Sales
of substantial amounts of our securities in the public market could depress the market price of our common stock.
Our
common stock is listed for trading on the Nasdaq Capital Market. If our stockholders sell substantial amounts of our common stock in
the public market, or the market perceives that such sales may occur, the market price of our securities could fall and we may be unable
to sell our securities in the future.
Our
securities may experience extreme price and volume fluctuations, which could lead to costly litigation for us and make an investment
in us less appealing.
The
market price of our common stock may fluctuate substantially due to a variety of factors, including:
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the
status and results of our clinical trials for our product candidate; |
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our
ability to fund and complete our study and, if such study provides data supporting an FDA submission, our ability to apply for and
obtain clearance from the FDA; |
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our
ability to remain a going concern; |
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our ability to maintain our Nasdaq listing; |
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our
business strategy and plans; |
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the
potential market for our product candidate, if approved for sale in the U.S.; |
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new
regulatory pronouncements and changes in regulatory guidelines and timing of regulatory approvals; |
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general
and industry-specific economic conditions; |
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variations
in our quarterly financial and operating results, including the rate at which we incur negative cash flow in future periods; |
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additions
to or departures of our key personnel; |
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changes
in market valuations of other companies that operate in our business segments or in our industry; |
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lack
of trading liquidity; |
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if
our product is approved and becomes available for us to sell in the U.S., whether we ultimately achieve profitability or not; |
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changes
in accounting principles; and |
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general
market conditions, economic and other external factors. |
The
market prices of the securities of early-stage companies, particularly companies like ours that are seeking to obtain regulatory approval
of their product candidate and do not yet generate operating revenue, have been highly volatile and are likely to remain highly volatile
in the future. This volatility has often been unrelated to the operating performance of particular companies. In the past, companies
that experience volatility in the market price of their securities have often faced securities class action litigation. Whether or not
meritorious, litigation brought against us could result in substantial costs, divert our management’s attention and resources and
harm our financial condition and results of operations.
Although
we have no preferred stock outstanding as of the date hereof and we have currently no intention to issue any preferred stock, our common
stockholders could be adversely affected by the issuance by us of preferred stock in the future, if any.
Our
certificate of incorporation does not restrict our ability to offer one or more series of preferred stock, any or all of which could
rank equally with or have preferences over our common stock as to dividend payments, voting rights, rights upon liquidation or other
types of rights. Our board of directors has the authority, without further action by the stockholders, to issue shares of preferred stock
in one or more series and to fix the rights, preferences and the number of shares constituting any series or the designation of such
series. In the case our board of directors decides to issue any preferred stock, we would have no obligation to consider the specific
interests of the holders of common stock in creating any such series of preferred stock or engaging in any such offering or transaction.
Our creation of any series of preferred stock or our engaging in any such offering or transaction could have a material adverse effect
on holders of our common stock.
We
have broad discretion in how we use the net proceeds of this offering, and we may not use these proceeds effectively or in ways with
which you agree.
Our
management will have broad discretion as to the application of the net proceeds of this offering and could use them for purposes other
than those contemplated at the time of the offering. We currently intend to use the net proceeds from the offering to fund IND-enabling
and Phase I and II clinical trials of product candidates, including radiation sensitizer Ropidoxuridine, IPdR/TPI and the HDAC inhibitor
small molecule technology platform, potential acquisition or in-licensing activities and working capital and general corporate purposes.
Our stockholders may not agree with the manner in which our management chooses to allocate and spend the net proceeds. Moreover, our
management may use the net proceeds for corporate purposes that may not increase the market price of our common stock.
If
we fail to comply with the continued listing requirements of Nasdaq, our common stock could be delisted, which could adversely
affect the market price and liquidity of our securities and could have other adverse effects.
On
September 10, 2024, we received a letter (the “Notification”) from Nasdaq notifying the Company that it is no longer in
compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market. Nasdaq
Listing Rule 5550(b)(1) requires listed companies to maintain stockholders’ equity of at least $2.5 million (the
“Minimum Stockolders’ Equity”). In the Company’s Quarterly Report on Form 10-Q for the period ended June
30, 2024, the Company reported stockholders’ equity of $801,434, which is below the minimum stockholders’ equity
required for continued listing pursuant to Nasdaq Listing Rule 5550(b)(1). Our stockholders’ equity in our Annual Report on
Form 10-K for the year ended December 31, 2024 of $709,152 is still not above the Minimum Stockholders’ Equity requirement,
and Nasdaq requires that we are able to achieve and show we can maintain compliance through June 30, 2025. In addition,
presently, the Company does not meet the alternatives of market value of listed securities or net income from continuing
operations.
The Company submitted a plan
to regain and maintain compliance with the Minimum Stockholders’ Equity requirement to Nasdaq and Nasdaq granted us until March
10, 2025 to raise additional capital to bring us back into compliance. As a result, we will be required to submit certain pro
forma balance sheet information to Nasdaq on or prior to March 10, 2025 to show that our capital raise efforts have brought us back into
compliance and/or will also be required to show compliance upon the filing of our Quarterly Report on Form 10-Q for the period
ending March 31, 2025.
While
we aim to regain compliance with Nasdaq’s stockholders equity requirement, we nonetheless run the risk that our stock may be delisted
if we fail to comply with Nasdaq listing requirements. In the event our common stock is delisted, we may seek to have our common stock
quoted on an over-the-counter marketplace, such as on the OTCQX. The OTCQX is not a stock exchange, and if our common stock trades on
the OTCQX rather than a securities exchange, there may be significantly less trading volume and analyst coverage of, and significantly
less investor interest in, our common stock, which may lead to lower trading prices for our common stock.
Any
potential delisting of our common stock from the Nasdaq may have materially adverse consequences to our stockholders, including:
● |
a
reduced market price and liquidity with respect to our shares of common stock, which could make our ability to raise new investment
capital more difficult; |
● |
limited
dissemination of market price of our common stock; |
● |
limited
news coverage; |
● |
limited
interest by investors in our common stock; |
● |
volatility
of the prices of our common stock, due to low trading volume; |
● |
our
common stock being considered a “penny stock,” which would result in broker-dealers participating in sales of our common
stock being subject to the regulations set forth in Rules 15g-2 through 15g-9 promulgated under the Exchange Act |
● |
increased
difficulty in selling our common stock in certain states due to “blue sky” restrictions; and |
● |
limited
ability to issue additional securities or to secure additional financing. |
If
you purchase our securities in this offering, you may experience future dilution as a result of future equity offerings or other equity
issuances.
We
may offer and issue additional shares of our common stock or other securities convertible into or exchangeable for our common stock in
the future. We are generally not restricted from issuing additional securities, including shares of common stock, securities that are
convertible into or exchangeable for, or that represent the right to receive, common stock or substantially similar securities. The issuance
of securities in future offerings may cause dilution to our stockholders, including investors in this offering. We cannot assure you
that we will be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the
price per share paid by investors in this offering, and investors purchasing other securities in the future could have rights superior
to existing stockholders. The price per share at which we sell additional shares of our common stock or other securities convertible
into or exchangeable for our common stock in future transactions may be higher or lower than the price per share in this offering.
Trading
of our common stock may be limited, making it difficult for our stockholders to sell their shares, and future sales of common stock could
reduce our stock price.
Our
common stock currently trades on Nasdaq under the ticker “SHPH.” The liquidity of our common stock may be limited, including
in terms of the number of shares that can be bought and sold at a given price and reduction in security analysts’ and the media’s
coverage of us, if any. These factors may result in different prices for our common stock than might otherwise be obtained in a more
liquid market and could also result in a larger spread between the bid and asked prices for our common stock. In addition, in the absence
of a large market capitalization, our common stock is less liquid than the stock of companies with broader public ownership, and, as
a result, the trading prices of our common stock may be more volatile. In the absence of an active public trading market, an investor
may be unable to liquidate his/her investment in our common stock. Trading of a relatively small volume of our common stock may have
a greater impact on the trading price of our stock. We cannot predict the prices at which our common stock will trade in the future,
if at all.
We
do not currently intend to pay dividends on our common stock in the foreseeable future and, consequently, your ability to achieve a return
on your investment will depend on appreciation in the price of our common stock.
We
do not anticipate paying any cash dividends to holders of our common stock for the foreseeable future. Consequently, investors must rely
on sales of their common stock after price appreciation, which may never occur, as the only way to realize any future gains on their
investments. There is no guarantee that shares of our common stock will appreciate in value or even maintain the price at which our stockholders
have purchased their shares.
The
offering price of the common stock or Pre-Funded Warrants may not be indicative of the value of our assets or the price at which securities
can be resold. The offering price of the common stock or Pre-Funded Warrants may not be an indication of our actual value.
The
public offering price per common stock or Pre-Funded Warrant is being determined based upon negotiations between the Company and the
Underwriter. Factors taken into consideration include the trading volume of our common stock prior to this offering, the historical
prices at which our shares of common stock have recently traded, the history and prospects of our business, the stage of development
of our business, our business plans for the future and the extent to which they have been implemented, an assessment of our management,
general conditions of the securities markets at the time of the offering, and such other factors as we and the Underwriter deems
relevant. No assurance can be given that our common stock can be resold at the public offering price for the shares. You may not receive
a positive return on your investment when you sell your shares of common stock and you may lose the entire amount of your investment
in the common stock and Pre-Funded Warrants.
The Pre-Funded Warrants are speculative in nature.
The
Pre-Funded Warrants offered hereby do not confer any rights of common stock ownership on their holders, such as voting rights or the
right to receive dividends, but rather merely represent the right to acquire shares of common stock at a fixed price. Specifically, commencing
on the date of issuance, holders of the Pre-Funded Warrants may acquire the common stock issuable upon exercise of such warrants at an
exercise price of $0.001 per share. Moreover, following this offering, the market value of the Pre-Funded Warrants will
be uncertain and there can be no assurance that the market value of such Pre-Funded Warrants will equal or exceed their public
offering price.
If
securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price
and trading volume could decline.
The
trading market for our common stock may depend in part on research and reports that securities or industry analysts publish about us
or our business. Securities and industry analysts do not currently, and may never, publish research on us. If securities or industry
analysts do not cover us or commence coverage of us, the trading price for our stock would likely be negatively impacted. In the event
securities or industry analysts initiate coverage, if one or more of the analysts who covers us downgrades our stock or publishes inaccurate
or unfavorable research about our business, our stock price may decline. If one or more of these analysts ceases coverage of us or fails
to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.
FINRA
sales practice requirements may limit a stockholder’s ability to buy and sell our securities.
Effective
June 30, 2020, the SEC implemented Regulation Best Interest requiring that “A broker, dealer, or a natural person who is an associated
person of a broker or dealer, when making a recommendation of any securities transaction or investment strategy involving securities
(including account recommendations) to a retail customer, shall act in the best interest of the retail customer at the time the recommendation
is made, without placing the financial or other interest of the broker, dealer, or natural person who is an associated person of a broker
or dealer making the recommendation ahead of the interest of the retail customer.” This is a significantly higher standard for
broker-dealers to recommend securities to retail customers than before under FINRA “suitability rules.” FINRA suitability
rules do still apply to institutional investors and require that in recommending an investment to a customer, a broker-dealer must have
reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending securities to their customers,
broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment
objectives and other information, and for retail customers determine the investment is in the customer’s “best interest”
and meet other SEC requirements. As a result, fewer broker-dealers may be willing to make a market in our common stock, reducing a stockholder’s
ability to resell shares of our common stock.
This
offering may cause the trading price of our shares of common stock to decrease.
The
price per common stock or Pre-Funded Warrant, may result in an immediate decrease in the market price of our shares. This decrease may
continue after the completion of this offering.
Resales
of our shares of common stock in the public market by the stockholders as a result of this offering may cause the market price of our
shares of common stock to decline.
Sales of substantial amounts of our shares
of common stock in the public market, or the perception that such sales might occur, could adversely affect the market price of our shares
of common stock. The issuance of new shares of common stock could result in resales of our shares of common stock by our current shareholders
concerned about the potential ownership dilution of their holdings. Furthermore, in the future, we may issue additional shares of common
stock or other equity or debt securities exercisable or convertible into shares of common stock. Any such issuance could result in substantial
dilution to our existing shareholders and could cause our stock price to decline.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents included herein contain forward-looking statements that involve risks and uncertainties. All statements
other than statements of historical facts contained in this prospectus or incorporated by reference in this prospectus
and the documents included herein are forward-looking statements. In some cases, you can identify forward-looking statements by terminology
such as “may,” “could,” “will,” “would,” “should,” “expect,”
“plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,”
“seek,” “contemplate,” “project,” “continue,” “potential,” “ongoing”
or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements
about:
|
● |
the
initiation, timing, progress and results of our research and development programs, preclinical studies, any clinical trials and INDs,
NDAs other regulatory submissions; |
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● |
our
expected dependence on third party collaborators for developing, obtaining regulatory approval for and commercializing product candidates; |
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● |
our
receipt and timing of any milestone payments or royalties under any research collaboration and license agreement we enter into; |
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● |
our
ability to identify and develop product candidates; |
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● |
our
or a collaborator’s ability to obtain and maintain regulatory approval of any of our product candidates; |
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● |
the
rate and degree of market acceptance of any approved products candidates; |
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● |
the
commercialization of any approved product candidates; |
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● |
our
ability to establish and maintain additional collaborations and retain commercial rights for our product candidates subject to collaborations; |
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● |
the
implementation of our business model and strategic plans for our business, technologies and product candidates; |
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our
estimates of our expenses, ongoing losses, future revenue and capital requirements; |
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our
ability to obtain additional funds for our operations; |
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our
ability to obtain and maintain intellectual property protection for our technologies and product candidates and our ability to operate
our business without infringing the intellectual property rights of others; |
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our
reliance on third parties to conduct our preclinical studies or any future clinical trials; |
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our
reliance on third party supply and manufacturing partners to supply the materials and components for, and manufacture, our research
and development, preclinical and clinical trial drug supplies; |
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● |
our
ability to attract and retain qualified key management and technical personnel; |
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our
use of net proceeds to us from this offering; |
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● |
our
expectations regarding the time during which we will be an emerging growth company under the JOBS Act; |
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our
financial performance; |
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global political and geopolitical changes, particularly
the transition in the U.S. presidential administration, and their impact on the pharmaceutical industry; and |
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developments
relating to our competitors or our industry. |
These
statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other
factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance
or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially
from current expectations include, among other things, those described in the section entitled “Risk Factors” in this prospectus
and contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which are included in this prospectus,
together with the information included in this prospectus, and in any free writing prospectus that we have authorized for use in connection
with this offering.
Any
forward-looking statement in this prospectus, incorporated by reference into this prospectus, and the documents included herein
reflects our current view with respect to future events and is subject to these and other risks, uncertainties and assumptions relating
to our operations, results of operations, industry, and future growth. Given these uncertainties, you should not place undue reliance
on these forward-looking statements. Except as required by U.S. federal securities law, we assume no obligation to update or revise these
forward-looking statements for any reason, even if new information becomes available in the future.
MARKET
AND INDUSTRY DATA AND FORECASTS
We
obtained the industry and market data used throughout this prospectus from our own internal estimates and research, as well as from independent
market research, industry and general publications and surveys, governmental agencies, publicly available information and research, surveys
and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts
and third- party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data
and our knowledge of our industry and market, which we believe to be reliable and reasonable. In some cases, we do not expressly refer
to the sources from which this data is derived. In addition, while we believe the industry and market data included in this prospectus
or incorporated by reference in this prospectus is reliable and based on reasonable assumptions, such data involve material risks
and other uncertainties and are subject to change based on various factors, including those discussed in the section entitled “Risk
Factors” and “Special Note Regarding Forward-Looking Statements.” These and other factors could cause results
to differ materially from those expressed in the estimates made by the independent parties or by us.
USE
OF PROCEEDS
We
estimate that the net proceeds from this offering, after deducting underwriting fees and estimated offering expenses payable by us, will
be approximately $5.2 million. We intend
to use the net proceeds from this offering to fund our Phase II clinical trial for our lead product candidate, including a revised work
order for $2.8 million in payments to Theradex Systems, Inc., the CROs supporting our Phase II clinical trials for our radiation sensitizer
Ropidoxuridine, and for working capital and general corporate purposes. In addition, we may use up to $2.0 million for marketing and
advertising services to communicate information about the Company to the financial community. We presently work with two IR/PR firms
and are planning to engage an additional firm to bolster the Company’s marketing and advertising outreach.
The
expected use of net proceeds from this offering represents our intentions based upon our current plans and business conditions, which
could change in the future as our plans and business conditions evolve. While we anticipate that the majority of the net proceeds will
be used to support our Phase II clinical trial for Ropidoxuridine, and the general corporate efforts required to support them, we cannot
currently allocate specific percentages of the net proceeds to us from this offering that we may use for the purposes specified above.
Our management will have broad discretion in the application of the net proceeds from this offering and could use them for purposes other
than those contemplated at the time of this offering. Our stockholders may not agree with the manner in which our management chooses
to allocate and spend the net proceeds. Moreover, our management may use the net proceeds for corporate purposes that may not result
in our being profitable or that increases our market value.
Pending
our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments,
including short-term, investment-grade, interest-bearing instruments and U.S. government securities.
MANAGEMENT
Our
directors and executive officers and their respective ages and titles are as follows:
Name |
|
Age |
|
Position(s)
and Office(s) Held |
|
|
|
|
|
Anatoly
Dritschilo, M.D. |
|
80 |
|
Chairman
of the board of directors and Co-Chief Executive Officer |
Christopher Cooper |
|
54 |
|
Interim Co-Chief Executive Officer |
Timothy
J. Lorber |
|
66 |
|
Chief
Financial Officer* |
Michael
Vander Hoek |
|
65 |
|
VP
for Operations and Regulatory, former Chief Financial Officer* |
Peter
Dritschilo |
|
55 |
|
President
and Chief Operating Officer |
Mira
Jung, Ph.D. |
|
74 |
|
Chief
Scientific Officer |
Tyvin
Rich, M.D. |
|
76 |
|
Chief
Clinical Officer |
Steven
Richards |
|
55 |
|
Independent
Director (1)(2) |
George
Scorsis |
|
48 |
|
Independent
Director (1)(2)(3) |
Oleh
Nabyt |
|
31 |
|
Independent
Director (1)(2)(3) |
Joseph
Tung |
|
41 |
|
Independent
Director (3) |
(1) |
Member
of the Audit Committee |
(2) |
Member
of the Compensation Committee |
(3) |
Member
of the Nominating and Corporate Governance Committee |
*Timothy
Lorber became our Chief Financial Officer on June 13, 2024. Prior to that time, Michael Vander Hoek served as our Chief Financial Officer.
Set
forth below is a description of the background and business experience of our directors and executive officers.
Anatoly
Dritschilo, M.D. Dr. Dritschilo is a co-founder of the Company and has served as Chief Executive Officer and Chairman of the Board
of Directors since the Company’s formation in December 2012. Since March 11, 2025, Dr. Dritschilo has served as Co-Chief Executive
Officer, with a focus on scientific research and development and clinical trials. Dr. Dritschilo is a radiation oncologist by training
and has held multiple leadership positions in health care. At Georgetown University Medical School in Washington, D.C., he served principally
as Department Chair from 1980 to 2022; Chief of Radiation Oncology at MedStar-Georgetown University Hospital from 2005 to 2022; Medical
Director of Georgetown University Hospital from 1994 to 1997; and Interim Director of the NCI-funded Lombardi Comprehensive Cancer Center
from 2005 to 2007. He has also served on the boards of directors of MedStar-Georgetown University Hospital, the National Capital Rehabilitation
Hospital, and the MedStar Health Research Institute. Previously, he was a founding director of Oncomed, Inc. and a member of the board
of directors of Neopharm, Inc. His 250+ scientific publications and 12 issued patents have earned him election as a Fellow of the National
Academy of Inventors. Dr. Dritschilo holds a Bachelor of Science degree in Chemical Engineering from the University of Pennsylvania,
a medical degree from the College of Medicine of New Jersey and residency training from the Harvard Joint Center for Radiation Therapy.
His qualifications support his service as our Chief Executive Officer and Chairman of the Board of Directors.
Christopher Cooper serves as
Interim Co-Chief Executive Officer, with a focus on business and capital markets, a position he has held since March 11, 2025. Mr. Cooper
has more than 27 years of experience in management and finance, having work in the oil and gas, telecommunications and technology industries.
In addition to his appointment as Interim Co-CEO of the Company, Mr. Cooper also serves as President, CEO and Founder of First Towers
& Fiber Corp., a telecommunications infrastructure company with operations in Latin America, positions he has held since 2017. From
2010 until 2017, Mr. Cooper served as President and CEO of Aroway Energy, Inc., a Vancouver, British Columbia-based oil and gas company,
where he was responsible for overseeing day to day operations, financial reporting, and oversaw acquisitions and debt and equity financing.
From 1998 until 2010, Mr. Cooper served as a Corporate Consultant to various companies in the technology and resources sectors, oversaw
restructuring activities for several distressed public companies, and was responsible for raising more than $100 million in debt and
equity for his clients. Mr. Cooper received his MBA from Dowling College in 1995 and his BBA in Business Administration from Hofstra
University.
Timothy
J. Lorber, CPA serves as the Company’s Chief Financial Officer, a position he assumed on a part-time basis on June 13,
2024 and on full-time basis on September 9, 2024. Mr. Lorber has more than 40 years of professional
finance experience, including Legg Mason, Inc. (“Legg Mason”), one of the world’s larger public global asset management
firms, where he worked from March 2006 to July 2020 serving in various finance leadership roles, including Managing Director and Chief
Accounting Officer until its sale in 2020. From August 2021 until June 2024, Mr. Lorber has served in leadership roles with several privately
held businesses, overseeing finance, technology and human resources functions. Prior to Legg Mason, Mr. Lorber served as Internal Audit
Director of Freddie Mac from August 2003 to March 2006 and has also worked for several international public accounting firms. Mr. Lorber
has extensive experience with mergers and acquisitions, valuations and complex accounting and financial reporting matters and holds a
Bachelor of Arts in Accounting from Loyola University, Maryland, and is a licensed CPA.
Michael
P. Vander Hoek serves as the Company’s Vice President, Operations and Regulatory, a position he has held since 2019, and served
as the Company’s Chief Financial Officer from 2019 until June 13, 2024. From November 2019 until April 2021, Mr. Vander Hoek served
as Director, Finance and Business Development at Georgetown Lombardi Comprehensive Cancer Center (“LCCC”), where he directed
a new five-year $221.9 million institutional commitment for cancer center research under a new NCI-approved cancer consortium arrangement
and recruited scientists to fulfill strategic objectives with senior leaders to improve cancer research and treatment. From 2007 until
November 2019, Mr. Vander Hoek served as Associate Director, Administration, at Georgetown’s LCCC, where he was responsible for
direct administrative operations for more than 400 faculty and staff in the department of oncology, radiation medicine, pathology and
biostatistics, bioinformatics and biomathematics, including managing $216.9 million in institutional commitments to LCCC from Medstar
Health, John Theurer Cancer Center (“JTCC”), and Georgetown University. and implementing an enterprise-wide clinical trial
management system for Georgetown University and Medstar Health. From 2004 until 2007, Mr. Vander Hoek served as Chief Financial Officer
at Georgetown’s LCCC. During his time at Georgetown, Mr. Vander Hoek negotiated a series of 12 research integration agreements
between LCCC and the JTCC that resulted in the approval of an NCI recognized Consortium in 2019. From 2001 until 2004, Mr. Vander Hoek
served as Vice-Chair, Planning and Administration, at MedStar Georgetown University Hospital, where he was responsible for managing administrative
and financial operations for some 440 staff, physicians, residents and fellows in the departments of Medicine and Neurology. From 1996
until 2001, Mr. Vander Hoek served as Senior Associate Administrator, Finance and Information Systems, for the Department of Medicine,
Georgetown University Medical Center, where he designed and managed the faculty compensation system, while managing the finances and
information systems for the department. His financial management experience in publicly held companies includes Director of Managed Care
Reimbursement for Critical Care America from 1990 to 1993 and Regional Controller for Laboratory Corporation of America (LabCorp) from
1993 to 1996. His responsibilities at both companies included extensive financial management related to mergers, acquisitions, and start-up
operations. Mr. Vander Hoek holds a Master’s in Health Services Administration from The George Washington University and a Bachelor
of Arts in Biology and Psychology from Hope College.
Peter
Dritschilo has served as our President and Chief Operating Officer since Shuttle was formed in December 2012. He also served as our
Chief Financial Officer until 2019. Mr. Dritschilo has more than 25 years of business management experience in medical services and cancer
treatment. He has held administrative positions with Medstar-Rad America from 2001 to 2005, Georgetown University 2005 to 2006, Prince
William Hospital and the Fauquier Hospital Cancer Center 2006 to 2011 and Inova Health System’s Schar Cancer Institute from 2011
to 2018. In 2014, Mr. Dritschilo filed for Chapter 7 bankruptcy protection due to the failure of a personal business venture. Mr. Dritschilo
graduated from Georgetown University and received his MBA from the George Washington University.
Mira
Jung, Ph.D., a co-founder of our company, has served as our Chief Scientific Officer for Biology since December 2012, and was a member
of our board of directors from our formation in December 2012 until 2019. Since 2004, Dr. Jung has served as Professor of Radiation Medicine
and Microbiology at Georgetown University Medical School. With over 30 years of experience in molecular radiation biology research, she
is an expert in mechanisms of radiation resistance and on the roles of HDAC inhibitors in modifying the radiation response. Dr. Jung’s
research has been funded by NIH and the DOD leading to 100+ publications and nine patents granted by the USPTO, including the first reports
of HDAC inhibitor drug classes modifying cancer cell radiation resistance and protecting normal tissues from radiation damage. Dr. Jung
holds an MA degree and a PhD in Microbiology and Molecular Virology from the University of Kansas, Lawrence.
Tyvin
A. Rich, M.D. serves as our company’s Chief Medical Officer and is responsible for the clinical development of novel radiation
sensitizers. Since 2010, Dr. Rich has served as a Staff Radiation Oncologist at the Hampton University Proton Therapy Institute in Hampton
Virginia and Professor Emeritus at University of Virginia Health Sciences Center, Department of Radiation Oncology. From 1995 until 2010,
Dr. Rich was a Professor and Chairman of the Department of Therapeutic Radiology and Oncology at the University of Virginia Health Sciences
Center. Prior to that, from 1984 through 1995, Dr. Rich was a Professor of Radiotherapy and Director of Clinics in the Department of
Radiotherapy of the University of Texas M. D. Anderson Cancer Center. He has served as the protocol chair for RTOG clinical trials that
advanced the use of chemoradiation for the treatment of rectal and pancreatic cancers. He is an expert in the applications of infusional
5-Fluorouracil for chemoradiation therapy of gastro-intestinal cancers and has authored more than 200 scientific articles, reviews and
book chapters. Dr. Rich received his undergraduate degree at Rutgers University, his medical degree at the University of Virginia, and
completed residencies in internal medicine at Georgetown University Medical Center and radiation therapy at Massachusetts General Hospital,
Harvard Medical School.
Steven
Richards. Mr. Richards was appointed to be a member of our Board of Directors in 2019. He is CEO and Founder of Endurance Media,
a media finance company based in Santa Monica, California, that launched in 2014 with a strategic alliance with eOne Entertainment and
a mandate to produce and finance commercially driven feature films. From 2006 to 2014, Mr. Richards served as Co-President and Chief
Operating Officer of Silver Pictures where he oversaw all business activities and managed a team of more than 20 people responsible for
film development, production, and financial information. From 2000 to 2006, he served as Chief Financial Officer at Silver Pictures and
from 1995 to 2000 as Vice President, Finance, at Silver Pictures. Mr. Richards holds an MBA in Finance from UCLA, a BBA in accounting
from Temple University, and holds his CPA license. We believe his experience as a chief financial officer and his knowledge of accounting
will assist in providing guidance and oversight to our Board of Directors as we grow our Company.
George
Scorsis. Mr. Scorsis has served as director of the Company since February 2025. Mr. Scorsis has over 25 years of experience
leading companies in highly regulated industries to rapid growth, including alcohol, energy drinks, medical cannabis, psychedelics
and cell based foods. Mr. Scorsis started his career in alcoholic beverage while attending York University in 2000, completing his
Bachelor in Administrative Studies. From July 2011 to October 2015, Mr. Scorsis served as the President of Red Bull Canada. During
this position, Mr. Scorsis was instrumental in restructuring the organization from a geographical and operational perspective,
growing the business to $150 million in revenue. From October 2015 to July 2017, Mr. Scorsis worked as President at Mettrum Health
Corp., a leading Canadian cannabis distributor. From July 2017 to February 2019, Mr. Scorsis served as the Chief Executive
Officer and Director of Liberty Health Sciences, which was one of the first Canadian companies to expand into the U.S. and was
fundamental in developing the platform which was most recently acquired for $372 million. From January 2015 to April
2018, Mr. Scorsis has served as Chairman of the Board of Directors of SOL Global Investments Corp. (formerly known as Scythian
Biosciences Corp.) Mr. Scorsis also currently serves as the Chairman of Entourage Health Corp.
(since February 2019) and Chairman of AWAKN Life Sciences (since January 2017) -Position at, both of which are
publicly traded on the TSX Venture Exchange and NEO Exchange. We believe his strong entrepreneurial background, as well as his detailed knowledge and experience working with biotech
and pharmaceutical companies, position him well to serve as an effective member of our board of directors.
Oleh
Nabyt. Mr. Nabyt has served as director of the Company since February 2025. Mr. Nabyt comes with a strong track record of
financial analysis and process improvement across multiple industries, with significant progression in roles and responsibilities.
From June 2017 to September 2018, Mr. Nabyt served as Financial Analyst at Zoetis. At Zoetis, he led data governance, developed KPI
dashboards, enhanced operational visibility, and played a key role in streamlining financial processes during a critical growth
phase. From September 2018 to April 2020, Mr. Nabyt served as a lead Financial Associate on the FP&A team at Hudson Group, a
newly public company. At Hudson Group, he worked directly under the Chief Financial Officer and closely with Investor Relations.
From May 2021 to present, Mr. Nabyt has served as Finance Manager at NCLH, where he oversees a $500M budget, continuing to take on
increasingly complex financial management and leadership responsibilities. Mr. Nabyt received his bachelor’s degree from
Rutgers University in 2016. His diverse experience positions him as a strategic finance professional, adept at driving both
operational excellence and financial efficiency. We believe his detailed knowledge of financial industries and public companies position him well to serve as an effective
member of our board of directors.
Mr.
Joseph Tung, age 41, has served as director of the Company since February 2025. Mr. Tung is a securities and corporate lawyer with
over a decade of experience advising clients across industries such as mining, technology, cryptocurrency, cannabis, and pharmaceuticals.
Mr. Tung became a Partner of Oakridge Law LLP in January 2025. Prior to this, from November 2021 to October 2024, he practiced securities
and corporate law at Garfinkle Biderman LLP, where he advised on stock exchange listings, securities offerings, corporate governance,
and business transactions including reverse takeovers and qualifying transactions. Previously, he worked at CC Corporate Counsel PC from
September 2020 to October 2021, where he handled continuous disclosure documents and stock exchange compliance, and from October 2019
to April 2020, he worked at Beber PC where he focused on secured lending and commercial real estate transactions. Mr. Tung holds dual
Canadian and American Juris Doctor degrees from the University of Windsor and University of Detroit Mercy, which he obtained in 2017,
a Bachelor of Mathematics from the University of Waterloo, which he obtained in 2006, and has completed two levels of the CFA (Chartered
Financial Analyst) exam. We believe his detailed knowledge of corporate and securities law, as well as his CFA and financial knowledge
and experience, position him to serve as an effective member of our board of directors.
Scientific
Advisory Committee
Ralph
R. Weichselbaum, M.D. has served as Scientific Advisor to Shuttle Pharmaceuticals for translational research for the discovery and
development of radiation response modifiers since 2013. Dr. Weichselbaum is the Daniel K. Ludwig Professor and Chairman of the Department
of Radiation and Cellular Oncology, the University of Chicago, a position he has held since 1985. He is also an elected member of the
Institute of Medicine, National Academy of Sciences. He has devoted his career to translational research in cancer with combined radiotherapy
and chemotherapy. Dr. Weichselbaum and his colleagues conceived “genetic radiotherapy” and developed viral constructs for
use in clinical tumor radiation sensitization. These were commercialized as TNFerade (GenVec, Inc.) and tested in a Phase I clinical
trial in prostate cancer and a Phase III clinical trial for pancreatic cancer.
Alejandro
Villagra, Ph.D. has served as a Scientific Advisor to Shuttle Pharmaceuticals with expertise in cellular signaling pathways, epigenetics
and immunology since 2017. Dr. Villagra received his Ph.D. in Molecular Biology from the University of Concepcion, in Chile in 2004 and
completed post-graduate training at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida in Molecular Immunology
in 2009, in the Laboratory of Eduardo Sotomayor, MD. He joined the faculty of the Moffitt Cancer Center and Research Institute, as a
research scientist from 2009 through 2015 and advanced to Assistant Professor of Oncologic Sciences. He became an Assistant Professor
in the Department of Biochemistry and Molecular Medicine at the George Washington University (GWU) School of Medicine and Health Sciences
in 2015, as a member of the GWU Cancer Center. His research is focused on molecular and cellular roles of histone deacetylases (HDACs)
in tumor immunology and as adjuvants for immunotherapy of cancers.
Joseph
Armstrong, III, Ph.D. joined as a Scientific Advisor to Shuttle Pharmaceuticals in 2021, He received his Ph.D. from the University
of Colorado in 1988, completed his post-doctoral work at the University of Virginia at Charlottesville and holds the position of Chief
Operating Officer at and Global Head of Business Development TCG GreenChem. He provides industry experience in chemistry, drug development
and process research, having previously held positions at Merck & Co. Inc. in Rahway, N.J and in the U.K. for two pharmaceutical
companies in the areas of Pharmaceutical Research and Development. His primary areas of focus have been in the design and implementation
of efficient synthesis of drug candidates amenable to large scale production. Dr. Armstrong led the development team that designed, developed
and implemented the manufacturing process for the new treatment for Type II diabetes, Januvia TM. His team was awarded the Solvias Prize
in 2004 (Basel, Switzerland), the IChemE Aztra-Zeneca Award for Green Chemistry and Engineering in 2005 (London, England), Dr. Armstrong
has more than 40 publications and holds 10 patents.
Family
Relationships
Dr.
Anatoly Dritschilo and Peter Dritschilo are father and son. There are no other family relationships among our directors and executive
officers.
Involvement
in Certain Legal Proceedings
During
the past ten years, no director, executive officer, promoter, or control person of the Company has been involved in the following:
|
(1) |
A
petition under the Federal bankruptcy laws or any state insolvency law which was filed by or against, or a receiver, fiscal agent
or similar officer was appointed by a court for the business or property of such person, or any partnership in which he was a general
partner at or within two years before the time of such filing, or any corporation or business association of which he was an executive
officer at or within two years before the time of such filing; |
|
|
|
|
(2) |
Such
person was convicted in a criminal proceeding or is a named subject of a pending criminal proceeding (excluding traffic violations
and other minor offenses); |
|
|
|
|
(3) |
Such
person was the subject of any order, judgment, or decree, not subsequently reversed, suspended, or vacated, of any court of competent
jurisdiction, permanently or temporarily enjoining him from, or otherwise limiting, the following activities: |
|
i. |
Acting
as a futures commission merchant, introducing broker, commodity trading advisor, commodity pool operator, floor broker, leverage
transaction merchant, any other person regulated by the Commodity Futures Trading Commission, or an associated person of any of the
foregoing, or as an investment adviser, underwriter, broker or dealer in securities, or as an affiliated person, director or employee
of any investment company, bank, savings and loan association or insurance company, or engaging in or continuing any conduct or practice
in connection with such activity; |
|
ii. |
Engaging
in any type of business practice; or |
|
|
|
|
iii. |
Engaging
in any activity in connection with the purchase or sale of any security or commodity or in connection with any violation of Federal
or State securities laws or Federal commodities laws; |
|
(4) |
Such
person was the subject of any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any Federal or State
authority barring, suspending or otherwise limiting for more than 60 days the right of such person to engage in any activity described
in paragraph (f)(3)(i) below, or to be associated with persons engaged in any such activity; |
|
|
|
|
(5) |
Such
person was found by a court of competent jurisdiction in a civil action or by the Commission to have violated any Federal or State
securities law, and the judgment in such civil action or finding by the Commission has not been subsequently reversed, suspended,
or vacated; |
|
|
|
|
(6) |
Such
person was found by a court of competent jurisdiction in a civil action or by the Commodity Futures Trading Commission to have violated
any Federal commodities law, and the judgment in such civil action or finding by the Commodity Futures Trading Commission has not
been subsequently reversed, suspended, or vacated; |
|
|
|
|
(7) |
Such
person was the subject of, or a party to, any Federal or State judicial or administrative order, judgment, decree, or finding, not
subsequently reversed, suspended, or vacated, relating to an alleged violation of: |
|
i. |
Any
Federal or State securities or commodities law or regulation; or |
|
|
|
|
ii. |
Any
law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent
injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal
or prohibition order; or |
|
|
|
|
iii. |
Any
law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or |
|
(8) |
Such
person was the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory
organization (as defined in Section 3(a)(26) of the Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section
1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange, association, entity or organization that
has disciplinary authority over its members or persons associated with a member. |
Board
of Directors
Our
board of directors is responsible for overseeing the Company’s business consistent with its fiduciary duty to the stockholders.
This significant responsibility requires highly skilled individuals with various qualities, attributes and professional experience. There
are general requirements for service on the board of directors that are applicable to directors and there are other skills and experience
that should be represented on the board of directors as a whole but not necessarily by each director. Our Corporate Governance and Nominating
Committee, detailed below, considers the qualifications of director candidates individually and in the broader context of the board of
directors’ overall composition and the Company’s current and future needs.
Terms
of Office
All
of our directors are elected to one-year terms to hold office until the next annual meeting of our stockholders and until a successor
is appointed and qualified, or until their removal, resignation, or death. Executive officers serve at the pleasure of the board of directors.
Director
Independence
In
order to qualify for continued listing on Nasdaq, our board of directors must consist of a majority of “independent” directors,
as defined under Nasdaq listing standards and Rule 10A-3(b)(1) under the Exchange Act. At present, four of the five directors
serving on our board of directors qualify as “independent.” Our independent directors consist of Messrs. Richards, Scorsis,
Tung and Nabyt.
Board
Committees
General
Our
board of directors has established three committees consisting of an audit committee, a compensation committee, and a nominating and
corporate governance committee. The members of each committee qualify as “independent” as defined under Nasdaq listing standards
and Rule 10A-3(b)(1). Moreover, at least one member of the audit committee qualifies as an “audit committee financial expert”
as the term is defined under Nasdaq listing standards and applicable rules and regulations of the SEC, based on their respective business
professional experience in the financial and accounting fields.
Audit
Committee
The
audit committee, which consists of Steven Richards, MBA, CPA (Chair), Oleh Nabyt and George Scorsis, assists our board of directors
in its oversight of the Company’s accounting and financial reporting processes and the audits of the Company’s financial
statements, including (a) the quality and integrity of the Company’s financial statements (b) the Company’s compliance with
legal and regulatory requirements, (c) the independent auditors’ qualifications and independence and (d) the performance of the
Company’s internal audit functions and independent auditors, as well as other matters which may come before it as directed by the
board of directors. Further, the audit committee, to the extent it deems necessary or appropriate, among its several other responsibilities,
will:
|
● |
be
responsible for the appointment, compensation, retention, termination and oversight of the work of any independent auditor engaged
for the purpose of preparing or issuing an audit report or performing other audit, review or attest services for the Company; |
|
|
|
|
● |
discuss
the annual audited financial statements and the quarterly unaudited financial statements with management and the independent auditor
prior to their filing with the SEC in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q; |
|
|
|
|
● |
review
with the Company’s management on a periodic basis (i) issues regarding accounting principles and financial statement presentations,
including any significant changes in our company’s selection or application of accounting principles; and (ii) the effect of
any regulatory and accounting initiatives, as well as off-balance sheet structures, on the financial statements of the company; |
|
|
|
|
● |
monitor
the Company’s policies for compliance with federal, state, local and foreign laws and regulations and the Company’s policies
on corporate conduct; |
|
|
|
|
● |
maintain
open, continuing and direct communication between the board of directors, the audit committee and our independent auditors; and |
|
|
|
|
● |
monitor
our compliance with legal and regulatory requirements and will have the authority to initiate any special investigations of conflicts
of interest, and compliance with federal, state and local laws and regulations, including the Foreign Corrupt Practices Act, as may
be warranted. |
Compensation
Committee
The
compensation committee, which consists of George Scorsis (Chair), Steven Richards and Oleh Nabyt, aids our board of directors
in meeting its responsibilities relating to the compensation of the Company’s executive officers and to administer all incentive
compensation plans and equity-based plans of the Company, including the plans under which Company securities may be acquired by directors,
executive officers, employees and consultants. Further, the compensation committee, to the extent it deems necessary or appropriate,
among its several other responsibilities, will:
|
● |
review
periodically our Company’s philosophy regarding executive compensation to (i) ensure the attraction and retention of corporate
officers; (ii) ensure the motivation of corporate officers to achieve the Company’s business objectives; and (iii) align the
interests of key management with the long-term interests of the Company’s stockholders; |
|
● |
review
and approve corporate goals and objectives relating to chief executive officer compensation and other executive officers of Shuttle; |
|
|
|
|
● |
make
recommendations to the board of directors regarding compensation for non-employee directors, and review periodically non- employee
director compensation in relation to other comparable companies and in light of such factors as the compensation committee may deem
appropriate; and |
|
|
|
|
● |
review
periodically reports from management regarding funding the Company’s pension, retirement, long-term disability and other management
welfare and benefit plans. |
Nominating
and Corporate Governance Committee
The
nominating and corporate governance committee, which consists of Joseph Tung (Chair), George Scorsis and Oleh Nabyt, recommends to the
board of directors individuals qualified to serve as directors and on committees of the board of directors to advise the board of directors
with respect to the board of directors composition, procedures and committees to develop and recommend to the board of directors a set
of corporate governance principles applicable to the Company, and to oversee the evaluation of the board of directors and Shuttle’s
management. In addition, the nominating and corporate governance committee will consider diversity of background including diversity
of race, ethnicity, international background, gender and age when evaluating candidates for board of directors membership.
Further,
the nominating and corporate governance committee, to the extent it deems necessary or appropriate, among its several other responsibilities
will:
|
● |
recommend
to the board of directors and for approval by a majority of independent directors for election by stockholders or appointment by
the board of directors as the case may be, pursuant to our by-laws and consistent with the board of director’s evidence
for selecting new directors; |
|
|
|
|
● |
review
the suitability for continued service as a director of each member of the board of directors when his or her term expires or when
he or she has a significant change in status; |
|
|
|
|
● |
review
annually the composition of the board of directors and to review periodically the size of the board of directors; |
|
|
|
|
● |
make
recommendations on the frequency and structure of board of directors meetings or any other aspect of procedures of the board of directors; |
|
|
|
|
● |
make
recommendations regarding the chairmanship and composition of standing committees and monitor their functions; |
|
|
|
|
● |
review
annually committee assignments and chairmanships; |
|
|
|
|
● |
recommend
the establishment of special committees as may be necessary or desirable from time to time; and |
|
|
|
|
● |
develop
and periodically review corporate governance procedures and consider any other corporate governance issue. |
Code
of Ethics
We
have adopted a code of ethics that applies to all of our executive officers, directors and employees. The code of ethics codifies the
business and ethical principles that govern all aspects of our business. This document will be made available in print, free of charge,
to any stockholder requesting a copy in writing from our secretary at our executive offices in Gaithersburg, Maryland. A copy of our
code of ethics is available on our website at www.shuttlepharma.com.
Insider
Trading Policies and Procedures
The
Company has adopted an insider trading policy, as amended and restated on March 10, 2023 (the “Insider Trading Policy”),
overseen by the Company’s corporate secretary, that applies to all (i) directors, (ii) executive officers and (iii) employees who
are exposed to insider information (together, the “Covered Persons”). The Insider Trading Policy prohibits the use of material
non-public information obtained by Covered Persons through their involvement with the Company when making decisions to purchase, sell,
give away or otherwise trade in the Company’s securities or to provide such information to others outside the organization. Under
the Insider Trading Policy, material non-public information includes, among other things, significant changes in the Company’s
prospects, significant write-downs, liquidity problems, changes in management, extraordinary borrowings, changes in debt, planned public
offerings or any other information that may be deemed material to the Company or the Company’s prospects. Further, we have established
black-out periods to which all Covered Persons are subject, including quarterly black-out periods, which commence three weeks before
the end of each quarter and continue until the quarterly results are disclosed by filing the Company’s Quarterly Report on Form
10-Q or Annual Report on Form 10-K. The Company may impose black-out periods from time to time as other types of material non-public
information occur when material non-public events or disclosures are pending. If the Company imposes a special black-out period, the
Company will notify Covered Persons accordingly. Covered Persons are permitted to trade in the Company’s securities only when there
is no black-out period in effect and such trade has been pre-cleared by the Company’s corporate secretary, or when a qualified
10b5-1 plan has been established in accordance with federal securities laws.
Clawback
Policy
While
the Company does not presently have in place any significant incentive compensation agreements or awards related to the Company’s
overall financial performance, the Company’s board of directors has adopted a clawback policy in order to comply with federal securities
laws. As such, we have adopted a clawback policy in which we may seek the recovery or forfeiture of incentive compensation paid by us,
including cash, equity or equity-based compensation, in the event we restate our financial statements under certain circumstances. The
clawback policy applies to our Section 16 officers, any employee who was eligible to receive incentive compensation and whose conduct
contributed to the need for a restatement, and any other former Section 16 officer or other employee who contributed to the need for
such restatement.
Board
of Directors Role in Risk Oversight
Members
of the board of directors have periodic meetings with management and the Company’s independent auditors to perform risk oversight
with respect to the Company’s internal control processes. The Company believes that the board of directors’ role in risk
oversight does not materially affect the leadership structure of the Company. The Company believes that its founders, leadership team
and members of the board of directors exemplify diversity and inclusivity with respect to race, sex and ethnic origin. The board of directors
presently has two diverse directors and is in the process of reviewing and vetting a female candidate to serve as a director. As such,
the Company anticipates being in full compliance with Nasdaq’s newly adopted diversity requirements by the end of its first year
of listing.
EXECUTIVE
AND DIRECTOR COMPENSATION
Summary
Compensation Table
The
table below summarizes all compensation awarded to, earned by, or paid to our Chief Executive Officer and Chief Financial Officer and
certain of our other executive officers for the fiscal years ended December 31, 2024 and 2023.
Name and principal position | |
Year | | |
Salary ($) | | |
Bonus ($) | | |
Stock
Awards ($) | | |
Option
Awards ($) | | |
Non-Equity Incentive Plan Compensation
($) | | |
Nonqualified
Deferred Compensation Earnings ($) | | |
All
Other Compensation ($) | | |
Total ($) | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Anatoly Dritschilo M.D., CEO | |
2024 | | |
| 274,000 | | |
| 0 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 274,000 | |
| |
2023 | | |
| 287,175 | | |
| 112,000 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 399,175 | |
| |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Timothy J. Lorber
CFO* | |
2024 | | |
| 97,641 | | |
| - | | |
| 100,000 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 197,641 | |
| |
2023 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| | |
| |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Michael Vander Hoek, VP, CFO* | |
2024 | | |
| 228,008 | | |
| - | | |
| 41,840 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 269,848 | |
| |
2023 | | |
| 230,530 | | |
| 72,000 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 302,530 | |
| |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Peter Dritschilo, President and COO | |
2024 | | |
| 236,000 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 236,000 | |
| |
2023 | | |
| 242,012 | | |
| 72,000 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 314,012 | |
| |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Tyvin Rich, Chief Medical Officer | |
2024 | | |
| 218,000 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 218,000 | |
| |
2023 | | |
| 220,226 | | |
| 43,000 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 263,226 | |
*
Michael Vander Hoek served as CFO through June 12, 2024, at which time Timothy Lorber assumed the position of CFO on a part-time basis
commencing June 13, 2024 and became full-time CFO on September 9, 2024.
Employment
Agreements
Each
of our executive officers has entered into an employment agreement with us. The employees each will receive compensation on an annual
basis in cash, payable in monthly installments commencing at the completion of our IPO, as well as restricted stock units (“RSUs”)
subject to achieving certain key performance indicators. Certain of our executive officers are entitled to various target bonuses, upon
achievement of certain milestones. The terms of the employment agreements are as follows:
Employment
Agreement with Anatoly Dritschilo, MD
On
June 28, 2019, we entered into an employment agreement with our Co-Chief Executive Officer and Chairman of the board of directors,
Anatoly Dritschilo, M.D. Under Dr. Dritschilo’s employment agreement, Dr. Dritschilo will receive base compensation of $274,000
per year. Dr. Dritschilo also received an initial RSU grant of 22,748 RSUs (2,844 on a post-reverse split basis) issuable under the Company’s
2018 Equity Incentive Plan (the “Plan”), which RSUs vested over three years in substantially equal one-third installments
on each one year anniversary of the agreement. Under his employment agreement, if Dr. Dritschilo terminates his employment for “Good
Reason,” as defined in the agreement, Dr. Dritschilo will be entitled to his then applicable base salary for period of 12 months,
subject to his continued compliance with certain requirements of his employment agreement. Dr. Dritschilo accepted a reduced salary prior
to the Company’s completion of its initial public offering in September 2022.
Employment
Agreement with Timothy J. Lorber
On
June 10, 2024, we entered into an employment agreement with our Chief Financial Officer, Timothy J. Lorber. Under Mr. Lorber’s
employment agreement, he will receive base compensation of $227,000 and is entitled to a target bonus of $72,000 upon achievement of
certain milestones. Mr. Lorber also received an initial RSU grant of $100,000 worth of RSU issuable under the Company’s Plan, which RSUs vest annually in one-third increments commencing on the first anniversary date of the grant of RSU, in accordance
with the terms of the RSUs award agreement.
Employment
Agreement with Michael Vander Hoek
On
September 1, 2019, we entered into an amended employment agreement with our pervious Chief Financial Officer and Vice President for Operations
and Regulatory, Michael Vander Hoek. Under Mr. Vander Hoek’s employment agreement, he will receive base compensation of $227,000
and is entitled to a target bonus of $72,000 upon achievement of certain milestones. Mr. Vander Hoek also received an initial RSU
grant of 6,096 RSUs (762 on a post-reverse split basis) and an additional grant of 12,500 RSUs on a post-reverse split basis on March
8, 2024 which were fully vested on the grant date and issued under the Company’s Plan. The initial RSU grant
vested over three years in substantially equal installments on each one year anniversary of the agreement Under Mr. Vander Hoek’s
employment agreement, if he terminates his employment for “Good Reason,” as defined in the agreement, he will be entitled
to his then applicable base salary for period of 12 months, subject to his continued compliance with certain requirements of his employment
agreement. Mr. Vander Hoek accepted a reduced salary prior to the Company’s completion of its initial public offering in September
2022. Effective September 10, 2024, Mr. Vander Hoek assumes the Vice President, Regulatory position on a full-time basis and stops being
our Chief Financial Officer.
Employment
Agreement with Peter Dritschilo
On
May 30, 2019, we entered into an employment agreement with our President and Chief Operating Officer, Peter Dritschilo. Under Mr. Dritschilo’s
employment agreement, Mr. Dritschilo will receive base compensation of $236,000 and is entitled to a target bonus of $72,000 upon achievement
of certain milestones. Mr. Dritschilo also received an initial RSU grant of 10,380 RSUs (1,298 on a post-reverse split basis)
issuable under the Company’s Plan, which RSUs vest over three years in substantially equal installments on
each one-year anniversary of the agreement. Under Mr. Dritschilo’s employment agreement, if Mr. Dritschilo terminates his employment
for “Good Reason,” as defined in the agreement, he will be entitled to his then applicable base salary for period of 12 months,
subject to his continued compliance with certain requirements of his employment agreement. Mr. Dritschilo accepted a reduced salary prior
to the Company’s completion of its initial public offering in September 2022.
Employment
Agreement with Tyvin Rich, M.D.
On
May 31, 2019, we entered into an employment agreement with our Chief Clinical Officer, Tyvin Rich, M.D. Under Dr. Rich’s employment
agreement, Dr. Rich receives base compensation of $218,000 per year and is entitled to a target bonus of $43,000 upon achievement of
certain milestones. Dr. Rich also received an initial RSU grant of 3,843 RSUs (481 on a post-reverse split basis) issuable
under the Company’s Plan, which RSUs vest over three years in substantially equal installments on each one
year anniversary of the agreement. Under Dr. Rich’s employment agreement, if Dr. Rich terminates his employment for “Good
Reason,” as defined in the agreement, he is entitled to his then applicable base salary for period of 12 months, subject to his
continued compliance with certain provisions of his employment agreement. Dr. Rich accepted a reduced salary prior to the Company’s
completion of its initial public offering in September 2022.
Employment
Agreement with Mira Jung, Ph.D.
Under
Dr. Jung’s employment agreement, entered into on May 1, 2023, Dr. Jung receives base compensation of $46,800 per year (representing
a 20% time commitment) and is entitled to a target bonus of $14,200 upon achievement of certain milestones. She also received an additional
grant worth $20,200 worth of RSUs in May 2023, vesting annually in one-third increments commencing on the first anniversary date of the
grant of RSUs. Dr. Jung also received an initial RSU grant of 892 RSUs (112 on a post-reverse split basis) issuable under the Company’s Plan in May 2019, which RSUs vest over three years in substantially equal installments on each one-year anniversary
of the agreement. Under Dr. Jung’s employment agreement, if Dr. Jung terminates her employment for “Good Reason,” as
defined in the agreement, Dr. Jung is then entitled to her then applicable base salary for period of 12 months, subject to her continued
compliance with certain requirements of her employment agreement. Dr. Jung accepted a reduced salary prior to the Company’s completion
of its initial public offering in September 2022.
Outstanding
Equity Awards at Fiscal Year-End
As
of December 31, 2024, a total of 1,109,741 RSUs have been granted to our executive officers and directors under our Plan, of which
869,468 RSUs have vested and 239,440 remain subject to vesting, after the acceleration of RSUs held by resigning directors
on February 28, 2025. The Company has filed a registration statement on Form S-8 (SEC File No. 333-268758) to register shares granted
under the Plan.
The
following table sets forth information concerning the number of shares of common stock underlying outstanding equity incentive awards
for each of our executive officers as of December 31, 2024:
| |
Option Awards | | |
| | | |
| Stock Awards | |
Name | |
Grant Date | |
| Number
of Securities Underlying Unexercised Options Exercisable
(#) | | |
| Number
of Securities Underlying Unexercised Options Unexercisable
(#) | | |
| Option
Exercise Price
($) | | |
| Option
Expiration Date | | |
| Number
of Shares or Units of Stock not yet Vested
(#)) | | |
| Market
Value of Shares or Units not yet Vested
($) | |
Mira Jung1 | |
5/1/23 | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,194 | | |
$ | 1,026 | |
Timothy Lorber2 | |
6/13/24 | |
| - | | |
| - | | |
| - | | |
| - | | |
| 28,455 | | |
$ | 24,443 | |
(1) |
These RSUs vest in
two installments on the anniversary of the grant date. |
(2) |
These RSUs vest in
three installments on the anniversary of the grant date. |
2018
Equity Incentive Plan
Our Plan provides for equity incentives to be granted to our employees, executive officers or directors and to key
advisers and consultants. Equity incentives may be in the form of stock options with an exercise price of not less than the fair market
value of the underlying shares as determined pursuant to the Plan, restricted stock awards, other stock- based
awards, or any combination of the foregoing. The Plan is administered by the Company’s compensation committee
or, alternatively, if there is no compensation committee, the Company’s board of directors. We have reserved 3,000,000 shares of
our common stock for issuance under the Plan, of which 1,187,189 shares have been granted under the Plan as of the date of this
registration statement.
Director
Compensation
Each
of our non-employee directors, pursuant to the terms of director agreements (the “Director Agreements”), between each of
the directors and the Company, receives compensation on an annual basis consisting of $25,000 in cash, payable in quarterly installments
commencing 90 days after completion of our initial public offering, and received RSUs upon their respective dates of election, one of
whom received $75,000 in RSUs and three of whom will, upon entry into director offer letters with the Company, receive $100,000 in RSUs.
The RSUs vest over a three-year period in one third increments on each of the first, second and third anniversary
following election. In addition, non-employee directors will also be reimbursed for out-of-pocket costs incurred in connection
with attending meetings. The Company provided its newly appointed directors compensation agreements consistent with previously
executed director agreements.
BENEFICIAL
OWNERSHIP OF SECURITIES
The
following table sets forth, as of the date of this registration statement, the beneficial ownership of our common stock by each director
and executive officer, by each person known by us to beneficially own 5% or more of our common stock and by directors and executive officers
as a group. Unless otherwise stated, the address of the persons set forth in the table is c/o Shuttle Pharmaceuticals Holdings, Inc.,
401 Professional Drive, Suite 260, Gaithersburg, MD 20879.
Beneficial
ownership is determined in accordance with SEC rules and generally includes voting or investment power with respect to securities. Unless
otherwise indicated, the stockholders listed in the table below have sole voting and investment power with respect to the shares indicated.
All
share ownership figures set forth in the below table include shares of our commons stock issuable upon securities convertible
or exchangeable into shares of our common stock, whether or not convertible or exchangeable within 60 days of the effective date of this
registration statement. Such shares are deemed outstanding and beneficially owned by such person only for purposes of computing
his or her percentage ownership, but not for purposes of computing the percentage ownership for any other person.
As
of March 3, 2025, there were issued and outstanding 4,916,772 shares of common stock.
Names and addresses | |
Number
of shares
of common
stock beneficially owned
(#) | | |
Percentage
of shares
of common
stock beneficially owned
before offering
(%) | | |
Number
of shares
of common
stock beneficially
owned after
the offering | | |
Percentage
of shares
of common stock
beneficially owned
after offering
(%) (1) | |
Directors and Named Executive Officers: | |
| | | |
| | | |
| | | |
| | |
Anatoly Dritschilo, M.D.(2) | |
| 639,083 | | |
| 13.0 | | |
| 639,083 | | |
| 10.2 | |
Christopher Cooper | |
| - | | |
| - | | |
| - | | |
| - | |
Timothy Lorber(3) | |
| - | | |
| - | | |
| - | | |
| - | |
Mira Jung, Ph.D.(4) | |
| 135,715 | | |
| 2.8 | | |
| 135,715 | | |
| 2.1 | |
Michael Vander Hoek | |
| 12,982 | | |
| 0.3 | | |
| 12,982 | | |
| - | |
Peter Dritschilo | |
| 820 | | |
| - | | |
| 820 | | |
| - | |
Tyvin A. Rich, M.D. | |
| 304 | | |
| - | | |
| 304 | | |
| - | |
Steve Richards(5) | |
| 214 | | |
| - | | |
| 214 | | |
| - | |
George Scorsis(6) | |
| - | | |
| - | | |
| - | | |
| - | |
Joseph Tung(6) | |
| - | | |
| - | | |
| - | | |
| - | |
Oleh Nabyt(6) | |
| - | | |
| - | | |
| - | | |
| - | |
All directors and officers as a group (eleven persons) | |
| 789,118 | | |
| 16.0 | | |
| 789,118 | | |
| 12.6 | |
| |
| | | |
| | | |
| | | |
| | |
Other 5% beneficial owners: | |
| | | |
| | | |
| | | |
| | |
Armistice Capital LLC(7) | |
| 306,057 | | |
| 6.2 | | |
| 306,507 | | |
| 4.9 | |
- |
Denotes
the holder owns less than one percent of the outstanding common stock. |
|
|
± |
The
persons named above have full voting and investment power with respect to the shares indicated. Under the rules of the SEC, a person
(or group of persons) is deemed to be a “beneficial owner” of a security if he or she, directly or indirectly, has or
shares the power to vote or to direct the voting of such security, or the power to dispose of or to direct the disposition of such
security. Accordingly, more than one person may be deemed to be a beneficial owner of the same security. |
|
|
(1) |
Accounts for the sale of 1,340,921 shares
of common stock, resulting in 6,257,693 shares of common stock outstanding following completion of this Offering. This
number does not include any shares from the exercise of
17,825,746 pre-funded warrants that remain subject to exercise. |
|
|
(2) |
Consists
of (i) 135,650 shares of common stock held of record by Dr. Anatoly Dritschilo, (ii) warrants to purchase 100,382 shares of common
stock, exercisable at $1.40 per share, (iii) 138,051 shares of common stock and warrants to purchase 2,500 shares of commons stock,
each held of record by Joy Dritschilo, his spouse, and (iv) 262,500 shares of common stock held by PAL Trust, a trust formed for
the benefit of Dr. and Mrs. Dritschilo’s adult children and for which a third party serves as external trustee and two of their
children serve as co-trustees. The above amounts do not include the potential conversion of a $250,000 convertible note, which may
be paid in cash or subject to conversion. Dr. Dritschilo disclaims beneficial ownership over all securities held by Mrs. Dritschilo
and PAL Trust. |
|
|
(3) |
Does
not include 28,455 RSUs that remain subject to vesting. |
|
|
(4) |
Does not include 1,194 RSUs that remain subject to vesting. |
|
|
(5) |
Does not include 209,791 RSUs that remain subject to
vesting. |
|
|
(6) |
Does not include 184,162 RSUs that remain subject to
vesting. |
|
|
(7) |
Based
on information provided in schedule 13G filed with the SEC on February 14, 2025 by Armistice Capital, LLC (“Armistice Capital”)
and Steven Boyd. Armistice Capital is the investment manager of Armistice Capital Master Fund Ltd. (the “Master Fund”),
the direct holder of the Shares, and pursuant to an Investment Management Agreement, Armistice Capital exercises voting and investment
power over the securities of the Company held by the Master Fund and thus may be deemed to beneficially own the securities
of the Company held by the Master Fund. Mr. Boyd, as the managing member of Armistice Capital, may be deemed to beneficially own
the securities of the Company held by the Master Fund. The Master Fund specifically disclaims beneficial ownership of the securities
of the Company directly held by it by virtue of its inability to vote or dispose of such securities as a result of its Investment
Management Agreement with Armistice Capital. Does not include 1,826,000 pre-funded warrants held by Armistice Capital,
which pre-funded warrants may be exercised from time to time and are subject to a 9.99% ownership limitation, and warrants to purchase
2,885,246 shares of common stock, which warrants remain subject to exercise and are subject to a maximum 9.99% ownership limitation. |
Change
of Control
The
Company is not aware of any arrangements which may at a subsequent date result in a change of control of the Company.
Securities
authorized for issuance under equity compensation plans
2018
Equity Incentive Plan
Our
2018 Equity Incentive Plan provides for equity incentives to be granted to our employees, executive officers or directors and to key
advisers and consultants. Equity incentives may be in the form of stock options with an exercise price of not less than the fair market
value of the underlying shares as determined pursuant to the Plan, restricted stock awards, other stock- based awards, or any combination
of the foregoing. The Plan is administered by the Company’s compensation committee or, alternatively, if there is no compensation
committee, the Company’s board of directors. We have reserved 3,000,000 shares of our common stock for issuance under the Plan,
of which 1,174,683 shares have been granted under the Plan as of the date of this registration statement and 244,439 remain
subject to vesting.
The
following table provides information as of December 31, 2024 about our equity compensation plans and arrangements, as adjusted for the
February 28, 2025 accelerated vesting of grants to resigning board members and the March 5, 2025 grants to new directors.
Plan category | |
Number of securities to be issued upon exercise of
outstanding options, warrants and rights | | |
Weighted- average exercise price of outstanding options,
warrants and rights | | |
Number of securities remaining available for future
issuance under equity compensation plans | |
Equity compensation plans approved by security holders | |
| 796,925 | | |
$ | 0.74 | | |
| 679,424 | |
Equity compensation plans not approved by security holders | |
| | | |
| | | |
| | |
Total | |
| 796,925 | | |
| 0.74 | | |
| 679,424 | |
*Outstanding
equity incentive grants consist entirely of RSUs which automatically vest over time into an equal number of shares of common stock at
no additional cost to the holder.
CERTAIN
RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Unless
described below, during the last two fiscal years, there were no transactions or series of similar transactions to which we were a party
or will be a party, in which:
● |
the
amounts involved exceed or will exceed $120,000; and |
|
|
● |
any
of our directors, executive officers or holders of more than 5% of our capital stock, or any member of the immediate family of any
of the foregoing had, or will have, a direct or indirect material interest. |
On
December 1, 2020, the Company consolidated two loans obtained in 2018 for a total of $350,000 from Joy Dritschilo, the wife our Chief
Executive Officer, which loans accrued interest at 7.5% since the date of inception, into a single loan between Mrs. Dritschilo
and the Company (the “2018 Consolidated Loan”) such that, with accrued interest, the 2018 Consolidated Loan had a principal
balance of $424,005.65, bore interest at a rate of 7.5% per annum, and had a maturity date of December 31, 2021. The 2018 Consolidated
Loan were then extended until June 30, 2022, pursuant to an amendment to the 2018 Consolidated Loan agreement dated January 24, 2022.
On July 29, 2022, the Company and Mrs. Dritschilo entered into an amendment to the 2018 Consolidated Loan, pursuant to which repayment
was extended through June 30, 2023. On January 15, 2023, following closing on the Convertible Note and Warrant offering to Ayrton Capital,
the 2018 Consolidated Loan was paid off in full.
On
December 1, 2020, the Company consolidated the May 2018 Loan and the September 2019 Loan with our Chief Executive Officer (the “2019
Consolidated Loan”), such that, with accrued interest, the 2019 Consolidated Loan had a principal balance of $138,448.20, bears
interest at the rate of 7.5% per annum, and has a maturity date of December 31, 2021. The 2019 Consolidated Loan was extended until June
30, 2022, pursuant to an amendment to the 2019 Consolidated Loan agreement dated January 24, 2022. On July 29, 2022, the Company and
our Chief Executive Officer entered into an amendment to the 2019 Consolidated Loan, pursuant to which repayment was extended through
June 30, 2023.
On
June 21, 2021, the Company entered into a loan agreement with Mrs. Dritschilo in the amount of $120,000 (principal), bearing interest
at the rate of 7.5% per annum, with a single balloon payment due at maturity on June 21, 2022 (the “June 2021 Loan Agreement”).
On July 29, 2022, the Company and Mrs. Dritschilo entered into an amendment to the June 2021 Loan Agreement, pursuant to which repayment
was extended through June 30, 2023.
On
August 1, 2022, in conjunction with our private placement of $125,000 of units consisting of 10% notes and warrants to purchase common
stock, which were sold to three accredited investors in total, Mrs. Dritschilo purchased a $50,000 note and received warrants to purchase
2,500 shares of common stock at $20.00 per share. The notes and warrants were sold pursuant to an exemption from registration pursuant
to Rule 506(b) of Regulation D of the Securities Act.
On
September 14, 2022, we entered into a manufacturing agreement with TCG GreenChem, the U.S. subsidiary
of TCG Lifesciences Pvt Ltd., a global contract research and manufacturing services company located in India. Dr. Chis Senanayake, one
of our independent directors, is CEO and CSO of TCG GreenChem and CSO of TCG Lifesciences Pvt Ltd. TCG GreenChem was contracted for process
research, development and cGMP compliant manufacture of IPdR, The Company paid TCG GreenChem $450,000 during the year ended December
31, 2022 and a total of $1,096,370 during the year ended December 31, 2023, completing the contract.
On September 4, 2024, the Company
entered into a loan agreement with our Chief Executive Officer, Dr. Anatoly Dritschilo, pursuant to which Dr. Dritschilo loaned the Company of $250,000 (principal), bearing
interest at the rate of 12% per annum and which is repayable in 12 substantially equal monthly installments over a one year period.
On
October 14, 2024, we entered into a securities purchase agreement with our Chief Executive Officer (the “Securities
Purchase Agreement”). Pursuant to the Securities Purchase Agreement, we issued a
$250,000 5% original issue discount senior secured convertible note and warrants to purchase up to a total of 100,382 shares
of common stock at an exercise price per share equal to $1.40 per share to Dr. Dritschilo. The convertible note matures one year
from the date of issuance (the “Term”), accrues interest at the rate of 14.5% per annum, and is convertible at a 110%
premium at any time beginning three months after the date of issuance. The Company has the option to prepay the convertible notes at
any time, upon 10 days written notice, for 107% of total outstanding balance (the “Optional Prepayment Right”). Any
outstanding principal will be paid in conversion of shares of common stock at the end of the Term, subject to the Company’s
exercise of the Optional Prepayment Right; any accrued interest will be repaid quarterly in cash. The conversion price of the
convertible notes will be the lower of a 15% discount to (i) $1.12072 per share or (ii) the price of any offering entered into by
the Company during the Term of the convertible notes, including the Company’s planned follow-on offering. The warrants are
immediately exercisable after issuance and will remain exercisable for a period of five years from the date of issuance. The
exercise price is subject to adjustment for any stock split, stock dividend, stock combination, recapitalization or similar event. As
of December 31, 2024, there was outstanding principal and interest balances for the related party note of $250,000 and $7,955,
respectively. Under the fair value option, the senior convertible note is $206,085 as of December 31, 2024.
On March 5, 2025, the
Company entered into a loan agreement with our Chief Executive Officer, Dr. Anatoly Dritschilo, pursuant to which Dr. Dritschilo loaned
the Company of $75,000 (principal), bearing interest at the rate of 18% per annum and which is repayable with accrued interest in one
month.
Review,
Approval and Ratification of Related Party Transactions
All
related party transactions are subject to the review, approval, or ratification of our board of directors or an appropriate committee
thereof.
CAPITALIZATION
The
following table sets forth our cash and cash equivalents and capitalization as of December 31, 2024:
|
● |
on
an actual basis; |
|
● |
on
a pro forma basis to reflect (i) a $2,000,000 Revolving Loan Agreement entered into on February 28, 2025 under which no loan amounts
have been disbursed and (ii) the acceleration of 840,205 restricted stock units granted under the 2018 Equity Incentive Plan to resigning
directors pursuant to the Revolving Loan Agreement closing. The acceleration of restricted stock units resulted in a compensation
expense charge of $430,084. |
|
● |
on a pro forma as adjusted basis to
reflect the sale of 19,166,667 shares of common stock, or Pre-Funded Warrants in lieu
thereof, in this offering at an offering price of $0.30 per share, resulting in net
proceeds of $5,199,674, after deducting approximately $532,500 in expenses,
but excluding proceeds from any exercise of the Pre-Funded Warrants being offered in this
offering.
|
Our
capitalization following the closing of this offering will depend on the actual public offering price and other terms of this offering
determined at pricing. Cash and cash equivalents are not components of our total capitalization.
| |
As of December 31, 2024 | | |
As of December 31, 2024 | | |
As of December 31,
2024
Pro Forma As | |
| |
Actual | | |
Pro Forma | | |
Adjusted | |
Cash and cash equivalents | |
$ | 1,920,144 | | |
| 1,965,144 | | |
$ | 7,164,818 | |
| |
| | | |
| | | |
| | |
Capitalization: | |
| | | |
| | | |
| | |
Revolving Loan Agreement | |
| - | | |
| - | | |
| - | |
Note payable - Related party | |
| 192,055 | | |
| 267,055 | | |
| 267,055 | |
Convertible Bridge Notes | |
| 684,205 | | |
| 684,205 | | |
| 684,205 | |
Stockholders’ equity: | |
| | | |
| | | |
| | |
Series A convertible preferred stock, $0.00001 par value; $1,000 per share liquidation value; 20,000,000
shares authorized; no shares outstanding | |
| | | |
| | | |
| | |
Common stock, $0.00001 par value; 100,000,000 shares authorized; 4,076,567 shares issued and outstanding at December 31, 2024,
actual; 4,916,772 shares pro forma; and 6,257,693 shares pro forma as adjusted | |
| 41 | | |
| 49
| | |
| 63 | |
Additional paid-in capital | |
| 35,287,212 | | |
| 35,753,042 | | |
| 40,952,703
| |
Accumulated deficit | |
| (34,578,101 | ) | |
| (35,043,940 | ) | |
| (35,043,940
| ) |
Total stockholders’ equity | |
| 709,152 | | |
| 709,152 | | |
| 5,908,826 | |
Total capitalization | |
$ | 1,585,412 | | |
| 1,660,412 | | |
$ | 6,860,086 | |
The
number of shares of common stock issued and outstanding actual, pro forma and pro forma as adjusted in the table above excludes 679,424
shares reserved for issuance under our 2018 Equity Incentive Plan; 3,464,281 warrants which remain subject to exercise; and 19,651,746
pre-existing unexercised pre-funded warrants, including the pre-funded warrants being issued herein.
DILUTION
If
you invest in our common stock in this offering, your ownership interest will be diluted immediately to the extent of the difference
between the public offering price per share of our common stock and the as adjusted net tangible book value per share of our common
stock immediately after this offering. As of December 31, 2024, our historical net tangible book value was $709,152,
or $.12 per share. Our historical net tangible book value is the amount of our total tangible assets less our total
liabilities. Historical net tangible book value per share represents historical net tangible book value divided by 5,902,567
shares (4,076,567 shares of our common stock outstanding and another 1,826,000 shares of common stock issuable under
pre-existing pre-funded warrants) as of December 31, 2024.
After
giving effect to the acceleration of restricted stock units and our issuance and sale of common stock, or Pre-Funded Warrants on lieu
thereof, in this offering at a public offering price of $.30 per share, and after deducting estimated underwriting fees
and estimated transaction expenses payable by us, our pro forma as adjusted net tangible book value as of December 31, 2024 would have
been $5,908,826 million, or $0.23 per share. This represents an immediate increase in as adjusted net tangible book value
per share of $5,199,674 to existing stockholders and immediate dilution of $0.07 in pro forma as adjusted net tangible
book value per share to new investors purchasing common stock in this offering. Dilution per share to new investors is determined by
subtracting as adjusted net tangible book value per share after this offering from the public offering price per share paid by
new investors.
The
following table illustrates this dilution on a per share basis:
Public offering price per share | |
$ | 0.30
| |
Historical net tangible book value per share as of December 31, 2024 | |
$ | 0.12 | |
Increase in as adjusted net tangible book value per share attributable to this offering | |
$ | 0.11
| |
As adjusted net tangible book value per share after giving effect to this offering | |
$ | 0.23
| |
Dilution in as adjusted net tangible book value per share to new investors in this offering | |
$ | 0.07 | |
The
information above is as of December 31, 2024 and excludes:
|
● |
Up
to 861,334 shares of our common stock issuable from time to time upon the conversion of outstanding Convertible Bridge Notes;
|
|
● |
3,464,281
shares of our common stock issuable upon the
exercise of outstanding warrants, with a weighted-average exercise price of $1.89 per share; and |
|
● |
679,424
other shares of our common stock reserved for
future issuance from time to time under our 2018 Equity Incentive Plan. |
DIVIDEND
POLICY
We
have not paid any dividends on our common stock since inception and we currently expect that, in the foreseeable future, all earnings,
if any, will be retained for the development of our business and no dividends will be declared or paid. Any future dividends will be
subject to the discretion of our board of directors and will depend upon, among other things, our earnings, if any, operating results,
financial condition and capital requirements, general business conditions and other pertinent facts.
DESCRIPTION
OF CAPITAL STOCK
Capital
Stock
Our
authorized capital stock consists of 100,000,000 shares of common stock, par value $0.00001 per share, and 20,000,000 shares of preferred
stock, par value $0.00001 per share.
Common
Stock
As
of the date of this prospectus, we had 4,916,772 shares of common stock issued and outstanding. Each holder of common stock is
entitled to one vote for each share owned on all matters voted upon by stockholders, and a majority vote is required for all actions
to be taken by stockholders. In the event we liquidate, dissolve or wind-up our operations, the holders of the common stock are entitled
to share equally and ratably in our assets, if any, remaining after the payment of all our debts and liabilities and the liquidation
preference of any shares of preferred stock that may then be outstanding. The common stock has no preemptive rights, no cumulative voting
rights, and no redemption, sinking fund, or conversion provisions.
Holders
of common stock are entitled to receive dividends, if and when declared by the board of directors, out of funds legally available for
such purpose, subject to the dividend and liquidation rights of any preferred stock that may then be outstanding.
Preferred
Stock
Our
board of directors has the authority, without further action by the stockholders, to issue shares of preferred stock in one or more series
and to fix the rights, preferences and the number of shares constituting any series or the designation of such series. While our certificate
of incorporation and by-laws, each as amended to date, do not contain any provisions that may delay, defer or prevent a change
in control, the issuance of preferred stock may have the effect of delaying or preventing a change in control or make removal of our
management more difficult. At present, our board of directors has authorized the issuance of up to 10,000 shares of Series A convertible
preferred stock, of which 1,212.5 shares were issued and subsequently converted into common stock following completion of our IPO. As
of the date of this prospectus, no preferred stock is issued or outstanding.
Series
A Warrants
In
conjunction with our sale of Series A Convertible Preferred Stock, our board of directors authorized the issuance of warrants to purchase
up to approximately 336,810 shares of common stock (42,113 shares on a post-reverse split basis) (the “Series A Warrants”),
to the holders of Series A Preferred Stock. The Series A Warrants were issued following consummation of our IPO, are exercisable for
a period of three years following issuance and have an exercise price of $32.00 per share.
January
2023 Note and Warrant Offering
On
January 11, 2023, we entered into the January 2023 SPA with the January 2023 Investor and consummated the sale to such
January 2023 Investor of the January 2023 Convertible Note with an initial principal
amount of $4,300,000, bearing interest at 5% per annum, and the January 2023 Warrant to purchase 1,018,079
shares (127,260 shares on a post-2024 Reverse Split Basis) of our common stock at a fixed exercise price of $2.35 per share ($18.80 per
share on a post-2024 Reverse Split Basis, and subsequently reset to $0.48).
The
January 2023 Convertible Note was sold with an original issue discount of $300,000. As such, the January 2023 Investor paid for
the January 2023 Convertible Note by delivering $4,000,000 in cash consideration to the Company. Boustead served as the sole placement
agent for the private placement (the “January 2023 Private Placement”) of the January 2023 Convertible Note and January 2023
Warrant. Boustead received a placement agent fee of $320,000 at the closing of the January 2023 Private Placement, representing 7.0%
of the gross cash proceeds at the closing plus 1% in non-accountable expenses. In addition, Boustead received a placement agent warrant
to purchase 71,266 shares (8,909 shares on a post-2024 Reverse Split basis) of common stock, representing 7.0% of the warrant shares
issued in the January 2023 Private Placement. After deducting the placement agent fee and our estimated expenses associated with the
January 2023 Private Placement, our net cash proceeds at the closing were approximately $3,590,000. As of September 30, 2024, the January
2023 Convertible Note had been paid in full.
The
January 2023 SPA
The
January 2023 SPA contains certain representations and warranties, covenants and indemnities customary for similar transactions.
Under the January 2023 SPA, we also agreed to the following additional covenants:
● |
So
long as the January 2023 Convertible Note remains outstanding, we will not effect or enter into an agreement to effect any variable
rate transaction other than a bona fide at-the-market offering or equity line of credit. |
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We
obtained majority stockholder consent approving the offering and the issuance of common stock upon conversion of the January 2023
Convertible Note and exercise of the January 2023 Warrant, as is required under the rules of the Nasdaq, and subsequently filed an
information statement on Schedule 14C (the “Information Statement”) informing all stockholders of the action and mailed
such Information Statement to all stockholders within 70 days of closing. |
In
addition, we granted the January 2023 Investor participation rights in future equity and equity-linked offerings of securities,
subject to certain limited exceptions, during the two years after the later of (a) the closing or (b) the date the January 2023 Convertible
Note no longer remains outstanding, in an amount of up to 30% of the securities being sold in such offerings. On February 26, 2025,
we entered into an amendment agreement with the Investor pursuant to which, in exchange for our payment of $75,000 to the Investor, the
Investor agreed to waive its participation rights in this Offering, and permanently waive any rights to seek a further investment of
Additional Notes and Additional Warrants (as such term is defined in the May 11, 2023 amendment agreement with the Investor).
January
2023 Convertible Note
General
The
January 2023 Convertible Note was issued to the January 2023 Investor on January 11, 2023 and matures on March 11, 2025 (subject
to extension in certain circumstances, including bankruptcy and outstanding events of default).
Amortization
Starting
on the earlier of (x) the date of a registration statement which registers the shares underlying the January 2023 Convertible Note is
declared effective by the SEC and (y) February 28, 2023, then on the first trading day of the month for each month thereafter, and on
the maturity date (each, an “Installment Date”), subject to certain exceptions and unless deferred as described below, the
Company is required to make monthly amortization payments equal to 1/26th of the unrestricted principal (and related unrestricted
original issue discount) and interest of the January 2023 Convertible Note payable (the “Installment Amount”), which must
be satisfied in cash at a redemption price equal to 105% of such Installment Amount (each, an “Installment Redemption”).
Notwithstanding
the foregoing, the noteholder may, at its sole option, elect to defer any Installment Amount until a subsequent Installment Date selected
by the noteholder, provided that any such deferred amounts shall not continue to accrue interest unless the deferral is at the request
of the Company.
Interest
The
January 2023 Convertible Note bears interest at a rate of 5% per annum and, upon any conversion or redemption, shall include a make-whole
of interest from such date of determination through the maturity date. After the occurrence and during the continuance of an Event of
Default (as defined in the January 2023 Convertible Note), the January 2023 Convertible Note will accrue interest at the rate of 15%
per annum. See “Events of Default” below.
Conversion;
Alternate Conversion upon Event of Default
The
January 2023 Convertible Note is convertible, at the option of the noteholder, into shares of our common stock at the lower of (i) $18.80
per share (post Reverse Split), (ii) 90% of the three lowest VWAPs in the 15 trading days prior to the payment date or (iii) 90% of the
VWAP on the trading day prior to the payment date. The conversion price is subject to full ratchet antidilution protection upon any subsequent
transaction at a fixed price lower than the conversion price then in effect and standard adjustments in the event of any stock split,
stock dividend, stock combination, recapitalization or other similar transaction. If we enter into any agreement to issue (or issue)
any variable rate securities, other than a bona fide at-the-market offering or equity line of credit, the noteholder has the additional
right to substitute such variable price (or formula) for the conversion price.
If
an Event of Default has occurred under the January 2023 Convertible Note, the noteholder may elect to alternatively convert the January
2023 Convertible Note at a redemption premium of 115% of the conversion amount. As of September 30, 2024, the January 2023 Convertible
Note was paid in full.
Subsequent
Placement Optional Redemption and Future Right of Participation
At
any time after the earlier of the date a noteholder becomes aware of any placement by us of equity or equity-linked securities or the
date of consummation of such a placement, subject to certain limited exceptions, the noteholder will have the right to have us redeem
a portion of each January 2023 Convertible Note not in excess of 30% of the net proceeds from such placement at a redemption price of
100% of the portion of the January 2023 Convertible Note subject to redemption. In addition, through March 11, 2026, the noteholder has
the right to be notified of any future offering of securities and to participate in up to 30% of the total offering amount. The subsequent
placement option has been terminated as the January 2023 Convertible Note has been satisfied in full and a one-time waiver of the participation
right has been granted for the purpose of this offering.
Covenants
We
are subject to certain customary affirmative and negative covenants regarding the incurrence of certain indebtedness, the existence of
liens, the repayment of indebtedness, the payment of cash in respect of dividends, distributions or redemptions, and the transfer of
assets, among other matters.
January
2023 Warrant
In
addition to the January 2023 Convertible Note, we issued a January 2023 Warrant exercisable for four (4) years for the purchase of an
aggregate of up to 127,260 shares of common stock, at an adjusted exercise price of $0.48 per share. The number of shares
underlying the January 2023 Warrant and exercise price are each subject to adjustment as provided under the terms of the January
2023 Warrant. If, at the time of exercise of the January 2023 Warrant, there is no effective registration statement registering, or no
current prospectus available for, the issuance of the shares underlying the January 2023 to the January 2023 Investor,
and the registration statement is not subject to SEC review and the Company has otherwise affirmatively failed to maintain such registration
statement’s effectiveness, then the January 2023 Warrant may also be exercised, in whole or in part, by means of a “cashless
exercise.” The January 2023 Warrant may not be exercised if, after giving effect to the exercise the January 2023 Investor,
would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately after giving effect to the
issuance of the shares underlying the January 2023 Warrant. At the January 2023 Investor’s option, the ownership
limitation blocker may be raised or lowered to any other percentage not in excess of 9.99%, as applicable, except that any raise will
only be effective upon 61-days’ prior notice to the Company.
If
the Company issues or sells, or the Company publicly announces the issuance or sale of, any shares of common stock, or convertible securities
or options issuable or exchangeable into common stock (a “New Issuance”), under which such common stock is sold for a consideration
per share less than the exercise price then in effect, the exercise price of the January 2023 Warrant will be adjusted to the New Issuance
price in accordance with the formulas provided in the January 2023 Warrant. Any such adjustment will not apply with respect to the issuance
of Excluded Securities (as defined in the January 2023 Warrant). In addition, if the Company enters into a Fundamental Transaction (as
defined in the January 2023 Warrants) at any time that a January 2023 Warrant is outstanding, then, upon any subsequent exercise of the
January 2023 Warrant, the January 2023 Investor will have the right to receive, for each January 2023 Warrant Share that would
have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, the number of shares of common
stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration
receivable as a result of such Fundamental Transaction by a holder of the number of shares of common stock for which the January 2023
Warrant is exercisable immediately prior to such Fundamental Transaction, provided, further, that if holders of common stock are not
offered or paid any consideration in such Fundamental Transaction, such holder of common stock will be deemed to have received common
stock of the successor entity (which entity may be the Company following such Fundamental Transaction) in such Fundamental Transaction.
Registration
Rights Agreement
Pursuant
to a Registration Rights Agreement, dated as of January 11, 2023, between the January 2023 Investor and the Company, we have granted
certain registration rights to the noteholder and January 2023 Warrant holder. The Registration Rights Agreement requires us to have
a registration statement declared effective by the 60th day following the date of the Registration Rights Agreement (of March
11, 2023), or the 90th day (or April 10, 2023) following the date of the Registration Rights Agreement in the event such registration
statement is subject to SEC review. It also grants the January 2023 Investor customary “piggyback” registration rights.
Additional
Information
The
foregoing is only a summary of the material terms of the January 2023 SPA, the January 2023 Convertible Note, the January 2023
Warrant, the Registration Rights Agreement, and the other ancillary transaction documents, and does not purport to be a complete description
of the rights and obligations of the parties thereunder.
October 2024 Convertible Notes and Warrants Offering
In October 2024, we sold a total of $831,579
of 5% original issue discount senior secured convertible notes, which notes convert into 861,334 shares of common stock,
subject to adjustment, and warrants to purchase 329,469 shares of common stock exercisable at a variable-weighted average of $1.42 per
share. The convertible notes have a term of one year, are may be converted at any time by the holder and are subject to mandatory conversion
at the end of the one-year holding period in the event the convertible notes are registered. The warrants have a term of five years and
contain standard anti-dilution protections.
October 2024 Public Offering Warrants
In conjunction with our October 2024
public offering, we issued pre-funded warrants to purchase 2,555,246 shares of common stock exercisable at $0.001 per share, and
warrants to purchase a total of 2,950,820 shares of common stock exercisable at $1.40 per share. The warrants are exercisable, at the
option of the holder, for a period of five years and are subject to either a 4.99% or 9.99% ownership limitation.
However, any holder may increase or decrease such percentage so long as it does not exceed 9.99%. The pre-funded warrants and
warrants are not transferrable without the consent of the Company and the holders have no voting rights until the warrants are exercised.
Anti-Takeover
Effects of Provisions of our Certificate of Incorporation, our By-laws and Delaware Law
Some
provisions of Delaware law, our certificate of incorporation and our by-laws contain provisions that could make the following
transactions more difficult: acquisition of us by means of a tender offer; acquisition of us by means of a proxy contest or otherwise;
or removal of our incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish or
could deter transactions that stockholders may otherwise consider to be in their best interest or in our best interests, including transactions
that might result in a premium over the market price for our shares.
These
provisions, summarized below, are expected to discourage coercive takeover practices and inadequate takeover bids. These provisions are
also designed to encourage persons seeking to acquire control of us to first negotiate with our Board of Directors. We believe that the
benefits of increased protection of our potential ability to negotiate with the proponent of a non-friendly or unsolicited proposal to
acquire or restructure us outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result
in an improvement of their terms.
Delaware
Anti-Takeover Statute
In
general, Delaware corporations are subject to Section 203 of the DGCL, which prohibits a Delaware corporation from engaging in any business
combination with any interested stockholder for a period of three years after the date that such stockholder became an interested stockholder,
with the following exceptions:
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before
such date, the board of directors of the corporation approved either the business combination or the transaction that resulted in
the stockholder becoming an interested holder; |
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|
|
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● |
upon
completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned
at least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining
the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by
persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to
determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; |
|
● |
on
or after such date, the business combination is approved by the board of directors and authorized at an annual or special meeting
of the stockholders, and not by written consent, by the affirmative vote of at least 662/3% of the outstanding
voting stock that is not owned by the interested stockholder; or |
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● |
the
corporation does not have a class of voting stock that is: (i) listed on a national securities exchange; or (ii) held of record by
more than 2,000 stockholders, unless any of the foregoing results from action taken, directly or indirectly, by an interested stockholder
or from a transaction in which a person becomes an interested stockholder |
In
general, Section 203 defines business combination to include the following:
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● |
any
merger or consolidation involving the corporation and the interested stockholder; |
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any
sale, transfer, pledge, or other disposition of 10% or more of the assets of the corporation involving the interested stockholder; |
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subject
to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation
to the interested stockholder; |
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● |
any
transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class or series
of the corporation beneficially owned by the interested stockholder; or |
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the
receipt by the interested stockholder of the benefit of any loss, advances, guarantees, pledges or other financial benefits by or
through the corporation. |
Section
203 defines interested stockholder as an entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation
or any entity or person affiliated with or controlling or controlled by such entity or person.
By-Laws
The
Company recently amended and restated its by-laws (the “Third Amended and Restated By-Laws”) to lower the quorum
requirement for calling a meeting of stockholders from a majority of shares outstanding to one-third or share outstanding. No other changes
were made when adopting the Third Amended and Restated By-Laws.
Nasdaq
Listing
Our
shares of common stock are traded on The Nasdaq Capital Market under the symbol “SHPH.” We do not intend to apply for the
listing of the Pre-Funded Warrants on any national securities exchange or other nationally recognized trading system.
Transfer
Agent
The
transfer agent and registrar of our common stock is VStock Transfer, LLC, of Woodmere, New York. Our transfer agent’s telephone
number is (212) 828-8436.
DESCRIPTION
OF SECURITIES WE ARE OFFERING
We
are offering, on a firm commitment underwritten basis 19,166,667 shares of common stock, or Pre-Funded Warrants in lieu thereof.
Common
Stock
The
material terms and provisions of our common stock are described under the caption “Description of Capital Stock” in this
prospectus.
Pre-Funded
Warrants
The
following summary of certain terms and provisions of the Pre-Funded Warrants that are being offered hereby is not complete and is subject
to and qualified in its entirety by the provisions of the forms of Pre-Funded Warrants which is filed as an exhibit to the registration
statement of which this prospectus is a part. Prospective investors should carefully review the terms and provisions of the form of Pre-Funded
Warrant for a complete description of the terms and conditions of the Pre-Funded Warrants.
The
term “prefunded” refers to the fact that the purchase price of our common stock in this offering includes almost the entire
exercise price that will be paid under the Pre-Funded Warrants, except for a nominal remaining exercise price of $0.001 per share.
The purpose of the Pre-Funded Warrants is to enable investors that may have restrictions on their ability to beneficially own more
than 4.99% (or, upon election of the holder, 9.99%) of our outstanding shares of common stock following the consummation of this offering
the opportunity to make an investment in the Company without triggering their ownership restrictions, by receiving Pre-Funded Warrants
in lieu of our common stock which would result in such ownership of more than 4.99% (or 9.99%), and receive the ability to exercise their
option to purchase the shares underlying the Pre-Funded Warrants at such nominal price at a later date.
Duration
and Exercise Price
Each
Pre-Funded Warrant offered hereby will have an initial exercise price of $0.001 per share. The Pre-Funded Warrants will be immediately
exercisable and may be exercised at any time until the Pre-Funded Warrants are exercised in full. The exercise price and number of shares
of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations
or similar events affecting our common stock and the exercise price.
Exercise
Limitation.
The
Pre-Funded Warrants will be exercisable, at the option of each holder, in whole or in part, by delivering a duly executed exercise notice
accompanied by payment in full for the number of purchased upon such exercise (except in the case of a cashless exercise as discussed
below). A holder (together with its affiliates) may not exercise any portion of the Pre-Funded Warrant to the extent that the holder
would own more than 4.99% (or, at the election of a purchaser, 9.99%) of the outstanding common stock immediately after exercise, except
that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding
stock after exercising the holder’s Pre-Funded Warrants up to 9.99% of the number of shares of common stock outstanding immediately
after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Pre-Funded Warrants.
No fractional shares of common stock will be issued in connection with the exercise of a Pre-Funded Warrant. In lieu of fractional shares,
we will pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price.
Fundamental
Transaction
In
the event of a fundamental transaction, as described in the Pre-Funded Warrants and generally including any reorganization, recapitalization
or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets,
our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding voting securities, the holders
of the Pre-Funded Warrants will be entitled to receive upon exercise of the Pre-Funded Warrants the kind and amount of securities, cash
or other property that the holders would have received had they exercised the Pre-Funded Warrants immediately prior to such fundamental
transaction, other than one in which a successor entity that is a publicly traded corporation (whose stock is quoted or listed for trading
on a national securities exchange, including, but not limited to, the New York Stock Exchange, the NYSE American, the Nasdaq Global Select
Market, the Nasdaq Global Market or the Nasdaq Capital Market) assumes the Pre-Funded Warrants such that the Pre-Funded Warrants
shall be exercisable for the publicly traded common stock of such successor entity.
Transferability
Subject
to applicable laws, a Pre-Funded Warrant may be transferred at the option of the holder upon surrender of the Pre-Funded Warrant to us
together with the appropriate instruments of transfer.
Exchange
Listing
We
do not intend to list the Pre-Funded Warrants on any national securities exchange or nationally recognized trading system.
No
Rights as a Stockholder
Except
as otherwise provided in the Pre-Funded Warrants or by virtue of such holder’s ownership of, the holders of the Pre-Funded Warrants
do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their Pre-Funded
Warrants.
UNDERWRITING
We have entered into an underwriting
agreement with WestPark Capital, Inc., or the Underwriter, with respect to the securities subject to this offering.
Subject
to certain conditions, we have agreed to sell to the Underwriter such securities listed next to their names in the below table at the
public offering price less the underwriting discounts and commissions set forth on the cover page of this prospectus.
We
have agreed to indemnify the Underwriter against specified liabilities, including liabilities under the Securities Act, and to
contribute to payments the Underwriter may be required to make in respect thereof.
Underwriter | |
Number
of Shares
of Common
Stock | |
WestPark Capital, Inc. | |
| 19,166,667 | |
| |
| | |
| |
| | |
Total | |
| 19,166,167 | |
Subject to the terms and conditions set
forth under the underwriting agreement, the underwriter has agreed to purchase 19,166,667 shares of common stock or Pre-Funded
Warrants offered by this prospectus.
The underwriter is offering the shares of common
stock, and Pre-Funded Warrants in lieu thereof, subject to various conditions and may reject all or part of any order. The Underwriter
has advised us that they propose initially to offer the shares of common stock to the public at the public offering price set forth on
the cover page of this prospectus and to dealers at a price less a concession not in excess of $0.288 per share of common stock,
or Pre-Funded Warrant in lieu thereof. After the shares of common stock and Pre-Funded Warrants are released for sale to the public,
the Underwriter may change the offering price, the concession, and other selling terms at various times.
Discounts and Commissions
The following table provides information regarding
the amount of the discounts and commissions to be paid to the Underwriter by us, before expenses.
| |
Per Share | | |
Per Pre-Funded Warrant | | |
Total | |
Public offering price | |
$ | 0.30 | | |
| 0.299 | | |
$ | 5,750,000 | |
Underwriting discounts and commissions (4%) | |
$ | .012 | | |
| .012 | | |
$ | 230,000 | |
Proceeds, before expenses, to us | |
$ | .288 | | |
| 0.28704 | | |
$ | 5,502,888 | |
The Company has agreed to pay
the Underwriter for: (i) reasonable aggregate expense allowance up to $80,000, and (ii) a non-accountable expense allowance equal to one percent (1%) of the gross proceeds received by us from the sale
of the securities in this offering. Prior to the effective date of this prospectus,
we have paid the Underwriter advances of $45,000, including a $25,000 retainer for its legal counsel and a $20,000 retainer for its anticipated
out-of-pocket costs, each of which shall be deducted against legal fees and transaction expenses, respectively. Such advance payments
will be returned to us to the extent such out-of-pocket expenses are not actually incurred in accordance with FINRA Rule 5110(g)(4)(A).
We estimate that our total expenses of the offering,
excluding the estimated underwriting discounts and commissions the fees of Underwriter’s legal counsel and the non-accountable
expense allowance, will be approximately $167,471.
Right
of First Refusal
We
have granted the Underwriter a right of first refusal for a period of three months commencing on the closing of the offering
to act as sole advisor, investment bank, book-running manager and/or placement agent, as applicable, at the Underwriter’s sole
discretion, for each and every public and private equity or debt financing transaction or merger and acquisition transaction by us, a
subsidiary or any successor, on compensation terms customary to the Underwriter. The Underwriter shall have the sole right to determine
whether or not any other broker dealer shall have the right to participate in any such offering and the economic terms of any such participation
and the Underwriter’s decision to not so act for any one or more of such offerings shall not be deemed a waiver of its continuing
rights under the right of first refusal. The Underwriter’s right of first refusal set forth in this paragraph shall
be subject to FINRA Rule 5110(g).
Lock-Up
Agreements
Pursuant
to certain “lock-up” agreements, our executive officers, directors and holders of at least 5% of our common stock and securities
exercisable for or convertible into common stock outstanding immediately upon the closing of this offering, have agreed, subject to certain
exceptions, not to offer, sell, assign, transfer, pledge, contract to sell, or otherwise dispose of or announce the intention to otherwise
dispose of, or enter into any swap, hedge or similar agreement or arrangement that transfers, in whole or in part, the economic risk
of ownership of, directly or indirectly, engage in any short selling of any shares of common stock or securities convertible into or
exchangeable or exercisable for any shares of common stock, whether currently owned or subsequently acquired, without the prior written
consent of the Underwriter, for a period of sixty (60) days after the closing date of the offering.
The Underwriter, in its sole discretion, may release the common stock and other securities subject to the lock-up agreements
described above in whole or in part at any time. When determining whether or not to release common stock and other securities from lock-up
agreements, the Underwriter will consider, among other factors, the holder’s reasons for requesting the release, the
number of shares of common stock and other securities for which the release is being requested and market conditions at the time.
The
Company agrees that, without the prior written consent of the underwriter, it will not, for a period of sixty (60) days after the date
of this prospectus (i) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract
to sell, grant any option, right or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any shares
of capital stock of the Company or any securities convertible into or exercisable or exchangeable for shares of capital stock of the
Company; (ii) file or cause to be filed any registration statement with the Commission relating to the offering of any shares of capital
stock of the Company or any securities convertible into or exercisable or exchangeable for shares of capital stock of the Company except
for a registration statement on Form S-8 in connection with the registration of shares of Common Stock issuable under any employee equity-based
compensation plan, incentive plan, stock plan, dividend reinvestment plan adopted and approved by the Company’s Board of Directors;
or (iii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of
ownership of capital stock of the Company, whether any such transaction described in clause (i), (ii), or (iii) above is to be settled
by delivery of shares of capital stock of the Company or such other securities, in cash or otherwise.
Other
Relationships
On February 28, 2025, the Company
entered into the Revolving Loan Agreement with the Lender. Pursuant to and under the terms of the Revolving Loan Agreement, the Company
issued to the Lender a Revolving Note in the principal amount of the “Maximum Outstanding Amount” which the Company may draw
upon at its discretion from time to time (the “Financing”). The Underwriter served as financial advisor to the Company with
regard to the Financing. As financial advisor, the Underwriter received a fee of $20,000 following the signing of the Revolving Loan
Agreement. As financial advisor, the Underwriter will be entitled to receive a fee of four percent (4%) with regard to each draw down
of the Revolving Note. Out of the Maximum Outstanding Amount, the Lender has not disbursed any loan amounts to date.
The Underwriter is a full-service financial institution engaged in various activities, which may include sales and trading,
commercial and investment banking, advisory, investment management, investment research, principal investment, hedging, market making,
brokerage and other financial and non-financial activities and services. The Underwriter may in the future provide various
investment banking, commercial banking and other financial services for us and our affiliates for which it may in the future
receive customary fees.
In
the ordinary course of their various business activities, the Underwriter and certain of its respective affiliates
may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial
instruments (including bank loans) for their own account and for the accounts of their customers, and such investment and securities
activities may involve securities and/or instruments issued by us and our affiliates. If the Underwriter or its respective
affiliates have a lending relationship with us, they routinely hedge their credit exposure to us consistent with their customary risk
management policies. The Underwriter and its respective affiliates may hedge such exposure by entering into transactions
that consist of either the purchase of credit default swaps or the creation of short positions in our securities or the securities of
our affiliates, including potentially the common stock offered hereby. Any such short positions could adversely affect future trading
prices of the common stock offered hereby. The Underwriter and certain of their respective affiliates may also communicate
independent investment recommendations, market color or trading ideas and/or publish or express independent research views in respect
of such securities or instruments and may at any time hold, or recommend to clients that they acquire, long and/or short positions in
such securities and instruments.
Regulation
M
The
Underwriter may be deemed to be an underwriter
within the meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the resale
of the shares sold by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act.
As an underwriter, each Underwriter would be required to comply with the requirements of the Securities Act and the Exchange Act,
including, without limitation, Rule 415(a)(4) under the Securities Act and Rule 10b-5 and Regulation M under the Exchange Act. These
rules and regulations may limit the timing of purchases and sales of shares by the Underwriter acting as principal. Under these
rules and regulations, the Underwriter:
●
may not engage in any stabilization activity in connection with our securities; and
●
may not bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted
under the Exchange Act, until it has completed its participation in the distribution.
Trading
Market
Our
common stock is listed on the Nasdaq Capital Market under the symbol “SHPH.” We do not intend to apply for listing of the
Pre-Funded Warrants on any securities exchange or other nationally recognized trading system.
LEGAL
MATTERS
The
validity of the securities offered hereby and certain legal matters in connection with this offering relating to U.S. law will be passed
upon for us by Dorsey & Whitney LLP, New York, NY. The Underwriter is represented by Lucosky Brookman LLP, Woodbridge, NJ, in connection with this offering.
EXPERTS
The
consolidated financial statements of Shuttle Pharmaceuticals Holdings, Inc. (the “Company”) as of and for the years
ended December 31, 2024 and 2023 incorporated by reference in this prospectus and in the registration statement of which
this prospectus forms a part, have been so incorporated in reliance on the reports of Forvis Mazars LLP, an independent registered
public accounting firm. Such consolidated financial statements have been incorporated herein in reliance upon such report given
on the authority of such firm as experts in accounting and auditing. The report of Forvis Mazars LLP contains an explanatory paragraph
regarding substantial doubt about the Company’s ability to continue as a going concern.
WHERE
YOU CAN FIND MORE INFORMATION
We
filed with the SEC a registration statement under the Securities Act for the securities offered by this prospectus. This prospectus does
not contain all of the information in the registration statement and the exhibits and schedule that were filed with the registration
statement. For further information with respect to us and our securities, we refer you to the registration statement and the exhibits
and schedule that were filed with the registration statement. Statements contained in this prospectus or incorporated by reference
into this prospectus about the contents of any contract or any other document that is filed as an exhibit to the registration statement
are not necessarily complete, and we refer you to the full text of the contract or other document filed as an exhibit to the registration
statement. The SEC maintains an Internet website at http://www.sec.gov that contains reports, proxy and information statements, and other
information regarding registrants that file electronically with the SEC.
We
file periodic reports and current reports under the Exchange Act, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q
and Current Reports on Form 8-K, and other information with the SEC. These periodic reports and other information are available for inspection
and copying at the SEC regional offices, public reference facilities and on the website of the SEC referred to above.
We
make available free of charge on or through our internet website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon
as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. The registration statement and
the documents referred to below under “Incorporation of Documents By Reference” are also available on our website, www.shuttlepharma.com.
The information found on our website, https://shuttlepharma.com, other than as specifically included in this prospectus, is not
part of this prospectus.
INCORPORATION
OF DOCUMENTS BY REFERENCE
This
prospectus is part of the registration statement but the registration statement includes and incorporates by reference additional information
and exhibits. The SEC permits us to “incorporate by reference” the information contained in documents we file with the SEC,
which means that we can disclose important information to you by referring you to those documents rather than by including them in this
prospectus. Information that is incorporated by reference is considered to be part of this prospectus and you should read it with the
same care that you read this prospectus and any subsequent prospectus supplement. Information that we file later with the SEC will automatically
update and supersede the information that is either contained, or incorporated by reference, in this prospectus, and will be considered
to be a part of this prospectus from the date those documents are filed.
We
incorporate by reference the documents listed below, all filings filed by us pursuant to the Exchange Act after the date of the registration
statement of which this prospectus forms a part, and any future filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d)
of the Exchange Act prior to the time that all securities covered by this prospectus have been sold; provided, however, that we are not
incorporating any information furnished under either Item 2.02 or Item 7.01 of any Current Report on Form 8-K and exhibits furnished
on such form that relate to such items:
|
1. |
The Company’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2024, filed with the SEC on February 26, 2025; |
|
2. |
The Company’s Current
Reports on Form 8-K filed with the SEC on January
7, 2025, January
21, 2025, January
28, 2025, February
26, 2025, February
27, 2025 , February
28, 2025 and March 12, 2025; and |
|
3. |
The description of the Company’s common stock contained
in the registration statement on Form
8-A filed with the SEC on August 29, 2022 pursuant to Section 12 of the Exchange Act, including any amendment or report filed for
the purpose of updating that description. |
We
will provide to each person, including any beneficial holder, to whom a prospectus is delivered, at no cost, upon written or oral request,
a copy of any or all of the information that has been incorporated by reference in the prospectus but not delivered with the prospectus.
Requests for documents should be by writing to or telephoning us at the following address: 401 Professional Drive, Suite 260, Gaithersburg,
MD 20879, (240) 430-4212. Exhibits to these filings will not be sent unless those exhibits have been specifically incorporated by reference
in such filings.
You
also may access these filings on our website at www.shuttlepharma.com. We do not incorporate the information on our website into this
prospectus or any supplement to this prospectus and you should not consider any information on, or that can be accessed through, our
website as part of this prospectus or any supplement to this prospectus (other than those filings with the SEC that we specifically incorporate
by reference into this prospectus or any supplement to this prospectus).
Any
statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus will be deemed modified,
superseded or replaced for purposes of this prospectus to the extent that a statement contained in this prospectus modifies, supersedes
or replaces such statement. Any statement contained herein or in any document incorporated or deemed to be incorporated by reference
shall be deemed to be modified or superseded for purposes of the registration statement of which this prospectus forms a part to the
extent that a statement contained in any other subsequently filed document which also is or is deemed to be incorporated by reference
modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed to constitute a part of the registration
statement of which this prospectus forms a part, except as so modified or superseded.
1,340,921
Shares of Common Stock
17,825,746
Pre-Funded Warrants to Purchase up to
17,825,746 Shares of Common Stock
17,825,746 Shares of Common Stock
Underlying such Pre-Funded Warrants
SHUTTLE
PHARMACEUTICALS HOLDINGS, INC.

WestPark
Capital, Inc.
PROSPECTUS
March
12, 2025
Shuttle Pharmaceuticals (NASDAQ:SHPH)
과거 데이터 주식 차트
부터 2월(2) 2025 으로 3월(3) 2025
Shuttle Pharmaceuticals (NASDAQ:SHPH)
과거 데이터 주식 차트
부터 3월(3) 2024 으로 3월(3) 2025