Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 1, 2024

Silo Pharma, Inc.

(Exact name of registrant as specified in its charter)

Nevada		001-41512		27-3046338
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

677 N. Washington Boulevard

Sarasota, FL

34236

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (718) 400-9031

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Rule 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of exchange on which registered
Common Stock, par value $0.0001 per share		SILO		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 – Other Events

On February 1, 2024, Silo Pharma Inc. (the “Company”) issued a press release announcing its pipeline prioritization for 2024 targeting mental health, chronic pain and neurology. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release dated February 1, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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.

	SILO PHARMA, INC.

Date: February 1, 2024	By:	/s/ Eric Weisblum
		Eric Weisblum
		Chief Executive Officer

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Exhibit 99.1

Silo Pharma Announces Pipeline Prioritization for 2024 Targeting Mental Health, Chronic Pain, and Neurology

Preparing Pre-Investigational New Drug Application for lead drug program SPC-15

Company plans to pursue FDA streamlined 505(b)(2) pathway for clinical drug development

SARASOTA, FL, Feb. 1, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced updates for its strategic 2024 focus for its clinical pipeline. The Company is advancing a diversified portfolio of four drugs targeting three health areas: mental health, chronic pain, and neurology.

“This year we are prioritizing clinical development of our post-traumatic stress disorder (PTSD) therapeutic, SPC-15, in collaboration with Columbia University, and we plan to submit a Pre-Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) by the end of the second fiscal quarter in 2024,” said Eric Weisblum, CEO of Silo. “Each of our novel therapeutics target underserved diseases with limited treatment options where we believe we can deliver quality medical care and make an impact.”

Silo’s lead program, SPC-15, is an intranasal prophylactic treatment for the treatment of PTSD and stress-induced anxiety disorder, an underserved market with few approved drugs. A dose-ranging non GLP study of SPC-15 is in progress, with a final validation report expected in the first half of 2024. With PTSD affecting 3.5%¹ of U.S. adults and few approved drugs, SPC-15's method of action could offer a new and much-needed treatment solution.

Silo’s next prioritized program is SP-26, an innovative non-opioid chronic pain solution, developed as an injectable and dissolvable time-release ketamine-loaded implant for fibromyalgia, utilizing the subcutaneous injection method. As a self-administered treatment, SP-26 holds the potential to be the first at-home ketamine treatment approved for chronic pain management.

Silo’s collaboration with Columbia University has also produced SPC-14, a nascent Alzheimer’s disease therapeutic. With initial positive results from animal studies and more data expected in 2024, Silo believes SPC-14 represents an encouraging development in Alzheimer’s disease research.

SPU-16, targeting multiple sclerosis (MS), is being developed in collaboration with the University of Maryland, Baltimore (UMB). The novel homing peptide is designed to cross the blood-brain barrier and target damaged tissue and inflammation.

Silo plans to utilize the FDA’s streamlined 505(b)(2) pathway for drug approval. This approach, allowing the inclusion of external safety and efficacy data in INDs, is expected to expedite the approval process and can reduce development costs significantly. Through its collaborations with Columbia University and UMB, Silo aims to leverage this pathway for each of SPC-15, SP-26, and SPC-14.

Silo Pharma

Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with Columbia University and the University of Maryland, Baltimore. For more information, visit www.silopharma.com and connect on social media at LinkedIn, X, and Facebook.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.

Contact
800-705-0120
investors@silopharma.com

American Psychiatric Association: What is Posttraumatic Stress Disorder?

Cover	Feb. 01, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 01, 2024
Entity File Number	001-41512
Entity Registrant Name	Silo Pharma, Inc.
Entity Central Index Key	0001514183
Entity Tax Identification Number	27-3046338
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	677 N. Washington Boulevard
Entity Address, City or Town	Sarasota
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	34236
City Area Code	718
Local Phone Number	400-9031
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	SILO
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false