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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
September 10, 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) |
| ☐ | 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 7.01 Regulation FD Disclosure.
Reference is made to the disclosure under Item
8.01 below which is hereby incorporated in this Item 7.01 by reference.
Item 8.01 Other Events.
Silo Pharma, Inc. (the “Company”)
has made available a presentation (the “Presentation”) management intends to use from time to time in presentations about
the Company’s operations and performance, including at the H.C. Wainwright 26th Annual Global Investment Conference on September
10, 2024 and will also be posted to the Company’s website on September 10, 2024. The Presentation is filed as Exhibit 99.1 to this
Current Report on Form 8-K (“Report”) and incorporated herein by reference
The information contained in the Presentation
is summary information that should be considered in the context of the Company’s filings with the Securities and Exchange Commission
and other public announcements the Company may make by press release or otherwise from time to time. The Presentation speaks as of the
date of this Report. While the Company may elect to update the Presentation in the future to reflect events and circumstances occurring
or existing after the date of this Report, the Company specifically disclaims any obligation to do so.
The Presentation contains forward-looking statements,
and as a result, investors should not place undue reliance on these forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
|
Description |
| 99.1 |
|
Presentation |
| 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: September 10, 2024 |
By: |
/s/ Eric Weisblum |
| |
|
Eric Weisblum |
| |
|
Chief Executive Officer |
Exhibit 99.1
NOVEL THERAPEUTICS FOR UNMET MEDICAL NEEDS Investor Presentation September 2024
FORWARD - LOOKING STATEMENTS This presentation 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 document or to reflect the occurrence of unanticipated events except as required by law. Nasdaq: SILO 2
We are a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions. UNMET MEDICAL NEEDS Post - traumatic stress disorder (PTSD) Stress - induced psychiatric disorders Fibromyalgia and chronic pain disorders Central nervous system (CNS) diseases Our focus is on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. Novel Therapeutics for Nasdaq: SILO 3
Clear timeline to first - in - human clinical trials for lead asset SPC - 15 following FDA guidance on pre - IND. Exclusive global licenses granted by Columbia University for two portfolio assets. Streamlined 505(b)(2) regulatory pathway for drug approval planned for priority drug candidates. Diversified pipeline of novel IP - protected technologies and assets. Market potential in central nervous system therapeutics industry. Assets well - protected by strong intellectual property portfolio. Sufficient capital resources to support upcoming catalysts. Accomplished leadership with broad expertise in life sciences. Multiple Levers for VALUE CREATION Nasdaq: SILO 4
Under - Addressed MEDICAL NEEDS Mental Health SPC - 15 | Intranasal PTSD treatment • Selective intranasal drug compound (non - psychedelic) • Patented nose - to - brain delivery bypasses blood - brain barrier • Direct, heightened drug concentration in the brain • Optimized patient safety and therapeutic delivery Chronic Pain SP - 26 | Non - opioid pain solution • Ketamine - based therapeutic implant targeting fibromyalgia • Self - administered treatment • Safely regulated dosage and time release Neurology SPC - 14 | Alzheimer’s Disease • Potential to improve and restore cognitive and memory function SPU - 16 | CNS homing peptide • Directly targets damaged tissue and inflammation in spinal cord Nasdaq: SILO 5
DRUG PIPELINE Our current assets have shown promise in a range of diseases and conditions including PTSD, chronic pain, Alzheimer’s Disease, and multiple sclerosis. Silo Pharma’s Nasdaq: SILO 6
INTRODUCTION Lorem ipsum dolor sit amet, consectetur adipiscing elit, eiusmod tempor incididunt ut labore et dolore magna Ut enim ad minim veniam, quis nostrud exercitation laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Route of nose to brain delivery SPC - 15 : PROPHYLACTIC TREATMENT FOR PTSD Drug: • Novel serotonin 4 (5 - HT4) receptor agonist that utilizes biomarkers for treatment Stage: • Pre - IND submitted for first - in - human trials Unmet need: • No new drug approvals for PTSD in nearly 25 years 1 • Affects estimated 3.9% of world’s population 1 • Cumulative prevalence in young people doubled from 2017 to 2022 to 7.5% 1 Competitive advantages: • Patented, cutting - edge intranasal nose - to - brain drug dispersion • Nose - to - brain method increases drug’s concentration in the brain • Faster onset of therapeutic benefit and optimized safety Blood Brain Barrier Nasdaq: SILO 1 FT Specialist, Endpoints in Focus, Lykos ’ pain is others’ gain as psychedelic biotechs take notes from adcomm vote. June 2024. 7
Drug: • Subcutaneous time - released ketamine - based injectable dissolvable implant Stage: • Preclinical research Unmet need: • Only FDA - approved drugs for fibromyalgia are 2 antidepressants and 1 anti - seizure medicine 1 • Chronic pain treatment market projected growth to $106.3B in 2028 at 7.9% CAGR 2 • Global fibromyalgia treatment market projected growth to $4.1B in 2032 at 4.3% CAGR 3 Competitive advantages: • Innovative non - opioid chronic pain therapeutic • Implant method designed to safely regulate dosage and time release • Attractive alternative to intravenous delivery Nasdaq: SILO SPC - 26 : KETAMINE IMPLANT FOR FIBROMYALGIA 1 WebMD, Fibromyalgia: Treatment and Medications. February 2024. 2 Business Research Company, Chronic Pain Market Growth Analysis With Investment Opportunities For 2024 - 2033. July 2024. 3 Precedence Research, Fibromyalgia Treatment Market Size to Worth USD 4.13 Billion by 2032. June 2024. 8
SPC - 14 : ALZHEIMER’S DISEASE PROGRAMS SPU - 16 : MULTIPLE SCLEROSIS NEUROLOGY Drug: • Novel drug targeting two receptor molecules Stage: • Preclinical research Unmet need: • Treatment market projected growth to $30.8B in 2033, at 18.8% CAGR 1 Competitive advantages: • Has shown efficacy against luteinizing hormone (LH) in attenuating learned helplessness, preservative behavior, and hyponeophagia (a measure of anxiety) 1 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. Drug: • Central nervous system homing peptide Stage: • Preclinical research Unmet need: • Global MS drugs market size projected growth to $38.9B by 2032, at a 7.9% CAGR 2 Competitive advantages: • Novel homing peptides reduce toxicity and advance payload of therapeutic 2 Fortune Business Insights, Multiple Sclerosis Drugs Market Size, Share & Industry Analysis… July 2024. Nasdaq: SILO 9
JANUARY Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. APRIL FEBRUARY Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. MARCH Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. TIMELINE Nasdaq: SILO 10
VALUE Our strategic business platform supports our ongoing development of novel drugs with the potential to transform patient care. Creating Nasdaq: SILO 11
FDA’s 505(b)(2) ABBREVIATED REGULATORY PATHWAY Silo Pharma intends to utilize the FDA’s streamlined 505(b)(2) pathway for its top two priority drug candidates, SPC - 15 and SP - 26. Section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act (FDCA) • Streamlined pathway to New Drug Application (NDA) approval for novel repurposed drugs • NDA relies upon publicly available data on active ingredient • Can significantly shorten clinical timelines and reduce drug development costs Nasdaq: SILO 12
Eric Weisblum CEO ◉ 20+ years investing, building and managing businesses ◉ Prior president of Sableridge Capital ◉ Former board member of Aikido Pharma., a Nasdaq - listed biotech company focused on the commercialization of oncology therapeutics James Kuo, M.D., MBA Vice President of R&D ◉ Current managing director of Athena Bioventures ◉ Formerly held executive positions in private and listed bioscience companies in the U.S., Canada, and Europe ◉ Chairman of the Board of ImmunoPrecise Antibodies and board director of Tryp Therapeutics ◉ Former CEO of Tryp Therapeutics, Synthetic Biologics, BioMicro Systems, and Discovery Laboratories Nasdaq: SILO MANAGEMENT Daniel Ryweck CFO ◉ Certified Public Accountant ◉ Formerly chief compliance officer of Mill City Ventures III Ltd, interim chief financial officer of Sun BioPharma, Inc., and director of Dala Petroleum Corp. KEY PERSONNEL 13
Charles B. Nemeroff M.D., Ph.D. Nasdaq: SILO ◉ Chair, Department of Psychiatry and Behavioral Sciences, Dell Medical School, University of Texas at Austin; director, Institute for Early Life Adversity Research, Department of Psychiatry and Behavioral Sciences, Mulva Clinic for the Neurosciences ◉ University of North Carolina (UNC) School of Medicine, Duke University ◉ Brain and Behavior Research Foundation; Anxiety and Depression Association of America (ADAA); National Academy of Medicine In addition to our work with world - renowned educational institutions, we engaged a scientific advisory chair for guidance regarding potential acquisitions and product development. ADVISORY 14 SCIENTIFIC
Wayne Linsley Director ◉ 40 years in business management ◉ Wide and varied skillset including sales and sales management, finance (public and private companies), accounting, audit support and financial reporting ◉ Independent director for Hoth Therapeutics Inc. (NASDAQ: HOTH) and DatChat Inc. (NASDAQ: DATS) Kevin Muñoz M.D. Director ◉ Director of Operations at Physical Medicine and Rehabilitation ◉ Former researcher with Harlem Health Promotion Center in New York ◉ Doctor of Medicine from Xavier University School of Medicine, B.S. from University of Michigan with distinction Jeff Pavell D.O. Director ◉ Site proctor for Rusk Institute residents training for Rehabilitation Medicine and Chief of Rehabilitation Medicine at Englewood Hospital and Medical Center in New Jersey ◉ Residency and chief residency at New York University Medical Center’s Rusk Institute of Rehabilitation and Bellevue Hospital, respectively, New York College of Osteopathic Medicine with honors BOARD OF DIRECTORS Nasdaq: SILO 15 Eric Weisblum CEO ◉ 20+ years investing, building and managing businesses ◉ Prior president of Sableridge Capital ◉ Former board member of Aikido Pharma, a Nasdaq - listed biotech company focused on the commercialization of oncology therapeutics
Key Collaborations and Exclusive collaborations with prominent medical research partners provide valuable IP, assets, and time - to - market advantages. INTELLECTUAL PROPERTY Columbia University • Exclusive worldwide rights to develop, manufacture, and commercialize SPC - 15 and SPC - 14 • Extensive issued and pending IP patent applications acquired with license agreement CRO & Manufacturing Partners include… University of Maryland, Baltimore • Exclusive, worldwide, sublicensable, royalty - bearing Master License Agreement • Rights to central nervous system - homing peptides for investigation and treatment of multiple sclerosis and other neuroinflammatory pathology Nasdaq: SILO 16
Pathway to first - in - human trials SPC - 15 SP - 26 502(b)(2) Exclusivity Non - opioid pain relief Streamlined pathway to FDA approval Strong asset protection Large CNS markets Market Size Partners Credentials Capital Prominent collaborations Broad life sciences expertise Sufficient resources, no debt VALUE Creating 17 Nasdaq: SILO
Nasdaq: SILO Thank you. Silo Pharma, Inc. | 677 N. Washington Blvd., Sarasota, FL 34236 Investor Relations Contact: 800 - 705 - 0120 | investors@silopharma.com 18
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