Exhibit 10.1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01 Entry Into A Material Definitive Agreement Definitive Agreement
On March 16, 2023, Shuttle Pharmaceuticals Inc. (“Shuttle Pharma”), a Maryland corporation and the wholly-owned subsidiary of Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company”), entered into a research agreement (the “Research Agreement”) with Georgetown University (“Georgetown”) for testing small molecule radiation sensitizers and immune activation candidates discovered and developed by Shuttle Pharma in cell-based and animal xenograft models. Under the Research Agreement, Georgetown will provide researching and testing services to Shuttle Pharma for a total estimated cost of $128,400. The Research Agreement has a term of one year from April 1, 2023 through March 31, 2024.
In conjunction with the Research Agreement, Shuttle Pharma entered into a material transfer agreement (the “MTA”), dated March 21, 2023, with Georgetown. Under the MTA, Shuttle Pharma agreed to transfer research quantities of candidate drug molecules to Georgetown, which Materials will be used by Georgetown solely to carry out additional research for Shuttle Pharma and which Materials shall at all times remain the property of Shuttle Pharma.
The foregoing summaries of each of the Research Agreement and the MTA do not purport to be complete and is each qualified in its entirety by reference to the Research Agreement and MTA, which are attached as Exhibits 10.1 and 10.2 hereto and incorporated herein by reference.
Item 4.01 Changes in Registrant’s Certifying Accountant.
On March 21, 2023, the Company’s audit committee selected FORVIS LLP (the “New Accountant”) to serve as the Company’s independent registered public accounting firm for the review of its Quarterly Reports on Form 10-Q and Annual Report on Form 10-K for the year ending December 31, 2023. As a result, the audit committee determined that BF Borgers CPA PC (the “Former Accountant”) would no longer serve as the Company’s independent registered public accounting firm, effective as of March 21, 2023.
The Former Accountant’s audit report on our financial statements for the years ended December 31, 2021 and 2022 contained no adverse opinion or disclaimer of opinion, nor was it qualified or modified as to uncertainty, audit scope or accounting principles, except that the audit report on the financial statements of the Company for the year ended December 31, 2021 contained an uncertainty about the Company’s ability to continue as a going concern (the “Going Concern Opinion”). The Former Auditor’s Going Concern Opinion was resolved following the Company’s completion of its approximately $11.4 million initial public offering in September 2022 and subsequent $4.0 million private placement in January 2023.
For the years ended December 31, 2022 and 2021 and through the date of this Current Report on Form 8-K, the Company had no “disagreements” (as defined in Regulation S-K, Item 304(a)(1)(iv) and the related instructions) with the Former Accountant on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedures, which disagreements if not resolved to the satisfaction of the Former Accountant would have caused them to make reference thereto in their reports on the financial statements for such periods.
There were no reportable events for the years ended December 31, 2022 or 2021 and through the date of this Current Report on Form 8-K, there were no reportable events as defined in item 304(a)(1)(v) of Regulation S-K.
Prior to retaining the New Accountant, the Company did not consult with the New Accountant regarding either: (i) the application of accounting principles to a specified transaction, either contemplated or proposed, or the type of audit opinion that might be rendered on the Company’s financial statements; or (ii) any matter that was the subject of a “disagreement” or a “reportable event” (as those terms are defined in Item 304(a)(1)(iv) and (a)(1)(v) of Regulation S-K, respectively).
On March 21 2023, the Company provided the Former Accountant with the disclosures contained in this Current Report on Form 8-K disclosing the dismissal of the Former Accountant and requested in writing that the Former Accountant furnish the Company with a letter addressed to the Securities and Exchange Commission stating whether or not they agree with such disclosures. The Former Accountant’s response is filed as Exhibit 16.1 to this Current Report on Form 8-K.
Item 7.01 Regulation FD Disclosure
On March 22, 2023, the Company posted an updated investor presentation on its website at www.shuttlepharma.com. A copy of the updated investor presentation is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
Item 8.01 Other Events
On March 22, 2023, the Company issued a press release announcing that Shuttle Pharma entered into the Research Agreement set forth in Item 1.01 above. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated by reference herein.
The information set forth in Item 7.01 and Item 8.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed subject to the requirements of amended Item 10 of Regulation S-K, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits |
| Exhibit No. | Description | |
| 10.1 | Research Agreement, dated March 16, 2023, between Shuttle Pharmaceuticals, Inc. and Georgetown University | |
| 10.2 | Material Transfer Agreement, dated March 21, 2023, between Shuttle Pharmaceuticals, Inc. and Georgetown University | |
| 16.1 | Letter from BF Borgers CPA PC to the Securities and Exchange Commission | |
| 99.1 | Press Release of Shuttle Pharmaceuticals Holdings, Inc. dated March 22, 2023 | |
| 99.2 | Investor Deck, dated March 22, 2023 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| 2 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: March 22, 2023 | ||
| SHUTTLE PHARMACEUTICALS HOLDINGS, INC. | ||
| By: | /s/ Anatoly Dritschilo | |
| Name: | Anatoly Dritschilo | |
| Title: | Chief Executive Officer | |
| 3 |
Exhibit 10.1
Exhibit 10.2
MATERIALS TRANSFER AGREEMENT
This MATERIALS TRANSFER AGREEMENT (the “Agreement”) is made effective as of the last date of signature hereto (the “Effective Date”), by and between Georgetown University (“Georgetown”), a nonprofit institution of higher education organized as a non-stock corporation under federal charter and whose principle place of business is situated at 37th & O Streets, N.W., Washington DC 20057, and Shuttle Pharmaceuticals, Inc. (“SPONSOR”), a for profit corporation under the laws of the State of Maryland, having its principal place of business at One Research Court, Suite 450, Rockville, Maryland 20850. Each of Georgetown and SPONSOR may hereinafter be referred to individually as a “Party” and collectively as the “Parties”.
WHEREAS, SPONSOR possesses certain material described below that it desires to transfer to Georgetown; and
WHEREAS, Georgetown desires to receive from SPONSOR the materials described below to carry out the Research as defined in and according to the sponsored research agreement between the Parties, effective on March 16, 2023 (“Sponsored Research Agreement”) (the “Purpose”), and
WHEREAS, the Parties further agree that this Agreement and all of its terms and conditions are intended to be consistent, and binding.
Now, THEREFORE, in reliance upon and in consideration of the following undertakings, and for other good and valuable consideration, the Parties hereby agree as follows:
1. SPONSOR shall transfer to Georgetown the following (collectively the “Materials”) :
| a. | SP-2-225 | |
| b. | SP-303 | |
| c. | SP-161 |
2. Upon receipt of the Materials, Georgetown may utilize its expertise and facilities to use the Materials provided by SPONSOR solely for the Purpose. Georgetown shall keep SPONSOR reasonably informed of the results of its evaluation, according to the Sponsored Research Agreement.
3. The Materials will remain the sole property of SPONSOR, and Georgetown will not sell, transfer, distribute, disclose or otherwise provide access to the Materials, or any materials that are replicated or derived from the Materials or that could not have been made but for the use of the Materials, to any person, research organization, university, commercial enterprise or other third party without the prior written consent of SPONSOR except that Georgetown may allow access to the Materials by employees and agents under its direct supervision and control for purposes consistent with this Agreement; provided that prior to such disclosure such individuals have been apprised of the proprietary nature of the Materials and are subject to obligations of confidentiality with respect to the Materials. Georgetown shall handle the Material in a manner which will ensure that reasonable steps are taken to remain consistent with this Agreement and the Sponsored Research Agreement. Furthermore, Georgetown shall ensure that no individual or employee will be permitted to take or send the Materials to any location outside of Georgetown’s facilities without the prior written consent of SPONSOR.
4. All other provisions including but not limited record keeping, confidentiality, publication, patents and inventions, use of names, liabilities, indemnification, assignment, governing law, government regulations, reporting requirements, and notices, shall be governed by the Sponsored Research Agreement.
5. In no event will SPONSOR be liable for Georgetown ‘s use of the Materials, except in the event SPONSOR has acted with gross negligence or willful misconduct. Georgetown hereby agrees to indemnify and hold harmless SPONSOR, its officers, employees, shareholders, directors and agents from and against all third-party claims of damages, costs or expenses for any loss, claim, injury or liability of any kind or nature, which may arise from Georgetown ‘s use, handling or storage of the Materials, except to the extent SPONSOR has caused such loss from its gross negligence or willful misconduct.
6. This Agreement shall terminate with termination of the Sponsored Research Agreement. Upon SPONSOR’s request and/or upon the termination of this Agreement, Georgetown shall either return or destroy, any remaining Materials.
7. This Agreement and the Sponsored Research Agreement sets forth all of the agreements and understandings between the Parties with respect to the subject matter hereof and supersedes and terminates all prior agreements and understandings between the Parties with respect to the subject matter hereof. This Agreement may be amended only by a writing duly signed by an authorized representative of each Party.
8. SPONSOR will bear all responsibility and costs associated packaging and shipping the Material to Georgetown.
IN WlTNESS WHEREOF, the Parties have caused this Material Transfer Agreement to be executed by their duly authorized representatives as of the Effective Date.
| Georgetown University | Shuttle Pharmaceuticals, Inc. | |||
| BY: | /s/ Tatiana Litvin-Vechnyak | BY: | /s/ Michael P. Vander Hoek | |
| Name: | Tatiana Litvin-Vechnyak, Ph.D. | Name: | Michael P. Vander Hoek | |
| Title: | Vice President, Technology Commercialization | Title: | CFO and VP Regulatory | |
| Date: | 03/21/2023 | Date: | 03/21/2023 | |
| Read and Acknowledged | ||||
| By: | /s/ Alejandro Villagra | |||
| Name: | Alejandro Villagra, Ph.D. | |||
| Date: | 03/21/2023 | |||
Exhibit 16.1
March 21, 2023
Securities and Exchange Commission
Office of the Chief Accountant
100
F Street N.E.
Washington, D.C. 20549
Re: Shuttle Pharmaceuticals Holdings, Inc.
File Ref. No. 001-41488
We have read the statements made by Shuttle Pharmaceuticals Holdings, Inc., which we understand will be filed with the Commission, pursuant to Item 4.01 of Form 8-K, as part of Shuttle Pharmaceuticals Holdings, Inc. Form 8-K report dated March 21, 2023. We agree with such statements as they pertain to our Firm in such Form 8- K.
We have no basis to agree or disagree with any other statements of the Company contained in Item 4.01.
Sincerely,
BF Borgers CPA PC
Exhibit 99.1
Exhibit 99.2
Shuttle Pharmaceuticals Enter Research Agreement with Georgetown University for Testing of Small Molecule Radiation Sensitizers and Immune Activation Candidates
ROCKVILLE, Md., March 22, 2023 — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), today announced it has entered a research agreement with Georgetown University focused on the evaluation of the Company’s lead HDAC6 inhibitor candidate, SP-2-225, evaluating the anti-tumor effect of the combination of SP-2-225 and RT in a syngeneic breast cancer model. The pre-clinical work outlined in the research agreement with Georgetown will support the Company’s IND-enabling studies in 2023 with a goal to submit an investigational new drug application (IND) for the selective HDAC6 inhibitor and initiation of a Phase I clinical trial in 2024.
Shuttle Pharmaceuticals has a longstanding strategic relationship with Georgetown University having been founded by Georgetown University Medical School faculty members. Alejandro Villagra, Ph.D., an associate professor at Georgetown University and member of the Shuttle scientific advisory board, will lead research efforts under the agreement. Dr. Villagra has expertise in cellular signaling pathways, epigenetics and immunology.
SP-2-225 is Shuttle Pharma’s pre-clinical class IIb selective HDAC inhibitorunder development for regulating the immune system after RT. 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.
Shuttle Pharma’s platform of sensitizers offers a pipeline of product candidates designed to address the urgent clinical need for new radiation sensitizer agents. In addition to the HDAC inhibitor candidates, the Company’s pipeline includes Ropidoxuridine, its lead clinical sensitizer drug candidate, to sensitize rapidly growing cancer cells which is advancing towards Phase II clinical testing in brain cancer patients undergoing radiation therapy.
“We are excited to extend and strengthen our collaboration with Dr. Villagra and Georgetown University to further evaluate our lead HDAC6 inhibitor candidate, SP-2-225,” commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. “Our goal is to build upon our leadership position in radiation sensitization, a market which is experiencing dynamic growth through the development of new radiation technology, the introduction of new agents, and growth in the number of diagnosed patients who may benefit from these treatments.”
About Shuttle Pharmaceuticals
Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharmaceuticals is a discovery and development stage specialty pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy. For more information, please visit our website at www.shuttlepharma.com.
Safe Harbor Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning the drug manufacturing and planned clinical trials for Ropidoxuridine and the development of our company. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the “Risk Factors” section of Shuttle Pharma’s Annual Report on Form 10-K for the year ending December 31, 2022, as filed with the SEC on March 15, 2023, or any subsequent SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Shuttle Pharmaceuticals
Anatoly Dritschilo, M.D., CEO
240-403-4212
info@shuttlepharma.com
Investor Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
shph@lythampartners.com