SILO Silo Pharma Inc

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

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

 

Date of Report (Date of earliest event reported): January 2, 2025

 

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)

 

☐

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

 

☐

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

 

☐

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

 

Securities registered pursuant to 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 January 2, 2025, Silo Pharma, Inc. (the “Company”) issued a Letter to Shareholders highlighting the Company’s progress and potential for its lead assets SPC-15 and SP-26 as treatments for mental health and chronic pain management, respectively

 

A copy of the January 2025 Letter to Shareholders is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Forward-looking Statements

 

The Company cautions that all statements, other than statements of historical facts, contained in this Current Report on Form 8-K, or furnished herewith, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement, including, but not limited to: (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates. Any forward-looking statement speaks only as of the date on which it was made. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		January 2, 2025 Letter to Shareholders
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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: January 2, 2025	By:	/s/ Eric Weisblum
		Eric Weisblum
		Chief Executive Officer

 

 

-2-

Exhibit 99.1

 

Silo Pharma Issues Letter to Shareholders Detailing Development Progress
and Potential for Lead Assets Targeting PTSD and Chronic Pain

 

	●	IND submission for intranasal SPC-15 treatment expected in 2025; Phase 1 clinical trial to follow upon approval

●

SP-26 ketamine implants nearing first animal studies

 

SARASOTA, FL, January 2, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” “we,” “us,” “our,” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today issued a letter to shareholders highlighting the Company’s progress and potential for its lead assets SPC-15 and SP-26 as treatments for mental health and chronic pain management, respectively. The letter, in its entirety, is reprinted below.

 

Dear fellow Silo Pharma shareholders,

 

Silo Pharma is gaining momentum along its path to first-in-human trials for lead candidate SPC-15, an intranasal prophylactic targeting PTSD and stress induced anxiety disorder. We are currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study and believe this will be the final data required before we submit an investigational new drug (IND) application to the FDA. I’m proud to report that we are getting closer to in-human trials.

 

In addition to SPC-15, we are advancing development of our SP-26 ketamine implant and continuing studies of our other investigational drugs. Each of these novel and potentially transformative therapies are tied to exclusive collaborations with world-class medical research partners, bringing valuable IP, assets and time-to-market advantages for Silo.

 

Through our ongoing commitment to developing novel therapeutics that address underserved conditions, Silo has created a robust platform of innovative solutions for mental health, chronic pain, and neurology.

 

SPC-15 | Intranasal PTSD Treatment

 

For our lead program, SPC-15, we completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) in September 2024 regarding our development plan. The primary purpose of the meeting was to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 as we prepare for an expected IND submission in 2025, followed by a Phase 1 clinical trial in PTSD upon approval of our IND. This would be a significant milestone for Silo.

 

While the initial indications for SPC-15 are PTSD and stress, our pre-clinical data could also support a possible Phase 1 trial of SPC-15 as a treatment for eating disorders and anorexia. Additionally, promising results from another pre-clinical study showed that a dual-action approach of combining SPC-15, a 5-HT4R agonist, with an NMDA receptor (NMDAR) antagonist enhanced efficacy as compared to either agent alone for the treatment of major depressive disorder (MDD) and other severe stress-related conditions.

 

Columbia University, our collaboration partner for pre-clinical development, granted Silo an exclusive global license to further develop, manufacture, and commercialize SPC-15 worldwide.

 

 

SP-26 | Ketamine-Loaded Implants

 

We continued our progress in the development and formulation of our novel SP-26 ketamine implants targeting fibromyalgia and chronic pain during 2024, and animal testing is scheduled to begin in early 2025. The unique design and development of the subcutaneous insertion device is expected to support sustained relief of chronic pain using a viable alternative to highly addictive opioid treatments.

 

Preclinical research to date has focused on ensuring that the safety profile of SP-26 aligns with FDA requirements for potential at-home therapeutic designation. If approved, SP-26 could become the first at-home injectable ketamine-based therapeutic.

 

We have initiated our first animal study to evaluate dosage, time release, and absorption of the drug, and we expect to share these results in early 2025.

 

Approval Pathways

 

If clinically successful, both SCP-15 and SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Under Section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act (FDCA), drug developers can use publicly available data on active ingredients in a compound for a new drug application (NDA). This streamlined pathway allows for significantly shortened clinical timelines and reduced clinical development costs as compared to the conventional full NDA process.

 

We believe this strategy could simplify our clinical plans and allow for a faster approval process, potentially accelerating our delivery of effective solutions for patients with access to few, if any, proven therapeutics.

 

Market Trends

 

The blood-brain barrier (BBB) is a major hurdle for the development of systemically delivered drugs targeting diseases of the central nervous system (CNS). Because of this barrier there is a huge unmet need for the treatment of these diseases, despite years of clinical research efforts across the pharmaceutical industry.¹

 

For PTSD, there have been no new drug approvals in nearly 25 years for a condition that affects an estimated 3.9% of the world’s population.² The Only FDA-approved drugs for fibromyalgia are two antidepressants and one anti-seizure medicine.³

 

Each of our neurology programs, SPC-14 for the treatment of Alzheimer’s disease and SPU-15 for the treatment of multiple sclerosis, address very large and growing markets. The Alzheimer’s disease treatment market shows projected growth to $30.8B in 2033, at 18.8% CAGR,⁴ and the global market for multiple sclerosis drugs is projected to grow to $38.9B by 2032, at a 7.9% CAGR.⁵

 

1

MDPI journals, Pharmaceutics, Novel Developments to Enable Treatment of CNS Diseases with Targeted Drug Delivery, March 2023.

2

FT Specialist, Endpoints in Focus, Lykos’ pain is others’ gain…., June 2024.

3

WebMD, Fibromyalgia: Treatment and Medications. February 2024.

4

Market.us, Alzheimer’s Disease Therapeutics Market Value to Reach USD 30.8 Billion by 2033 | Driven by the Advancements in Neurological Research. January 2024.

5

Fortune Business Insights, Multiple Sclerosis Drugs Market Size, Share & Industry Analysis… July 2024.

 

 

Creating Value

 

In closing, we believe our progress in 2024 sets us up for exciting developments and milestones for Silo in 2025. Our current balance sheet, with cash on hand and minimal debt, offers financial flexibility as we move forward with ongoing research and development of therapies with the potential to transform patient care.

 

Silo Pharma is committed to delivering compelling catalysts for value creation for our existing and future shareholders. We are enthusiastic about the future and grateful for your interest and continued support.

 

Sincerely,

 

Eric Weisblum

Chief Executive Officer

 

December 2024

 

About SPC-15

 

SPC-15 is a serotonin 5-HT4 receptor agonist designed to treat stress-induced disorders such as PTSD and anxiety. Delivered via an intranasal formulation, SPC-15 may qualify for the FDA’s streamlined 505(b)(2) regulatory pathway, potentially accelerating its approval process. Currently, Silo Pharma is collaborating with Columbia University on preclinical studies and holds exclusive rights to develop and commercialize SPC-15 globally.

 

About SP-26

 

SP-26 is a ketamine-based injectable dissolvable polymer implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.

 

 

About 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 universities and independent laboratories. 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 using 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

 

 

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v3.24.4

Cover	Jan. 02, 2025
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Jan. 02, 2025
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
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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

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