Silo Pharma’s PTSD Candidate SPC-15 Achieves Positive Safety Milestone, Paving Way for Accelerated Clinical Trials Under 505(b)(2) Pathway

Rhea-AI Summary

Silo Pharma (Nasdaq: SILO) announced positive safety results for its PTSD drug candidate SPC-15 in a FDA-requested 7-day large animal safety study. The intranasal spray formulation demonstrated local and systemic safety with no toxicities at clinical-representative doses, showing comparable systemic exposure to standard oral administration.

The company is pursuing FDA approval through the 505(b)(2) pathway, which could streamline the approval process by leveraging existing safety data. Silo is currently conducting IND-enabling GLP toxicology studies and evaluating clinical trial sites. The PTSD market, valued at $1.8 billion in 2024, is projected to reach $3.2 billion by 2034.

Positive

• None.

Negative

• Still in early developmental stage requiring additional studies
• Multiple steps remaining before human trials can begin
• Faces competition in established PTSD treatment market

News Market Reaction

-6.54%

8 alerts

-6.54% News Effect

+15.7% Peak Tracked

-9.4% Trough Tracked

-$465K Valuation Impact

$7M Market Cap

0.3x Rel. Volume

On the day this news was published, SILO declined 6.54%, reflecting a notable negative market reaction. Argus tracked a peak move of +15.7% during that session. Argus tracked a trough of -9.4% from its starting point during tracking. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $465K from the company's valuation, bringing the market cap to $7M at that time.

Data tracked by StockTitan Argus on the day of publication.

SPC-15’s intranasal spray formulation meets safety standards for clinical trial development

SARASOTA, FL, Aug. 19, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company), a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company, today announced positive bioanalytical and safety/toxicology results for its U.S. Food and Drug Administration (FDA)-requested 7-day large animal safety study of its lead asset SPC-15.

Silo CEO Eric Weisblum commented, “Overall, we believe the positive results of this study confirm that SPC-15’s formulation and spray profile meets the safety standards for clinical trials. While the safety of the oral counterpart to SPC-15 is well documented, our challenge was to develop a viable intranasal therapeutic dose that meets the same safety standards while offering distinct advantages over oral delivery. So far, we believe our intranasal nose-to-brain formulation has met that challenge and supports our potential to bring a safe, easily administered, and rapidly absorbed PTSD therapeutic to market.”

The preclinical study compared the safety and overall exposure of the SPC-15 intranasal spray formulation (intended for clinical use) to oral drug administration. Data showed that SPC-15, administered at clinical-representative doses, demonstrated local and systemic safety with no toxicities identified. The study also showed that systemic exposure of intranasal SPC-15 administered at the anticipated therapeutic range is comparable to standard oral administration, which we believe validates the drug’s potential as a targeted intranasal therapeutic for PTSD and stress-induced anxiety that has a potentially greater safety profile.

In our opinion, the study data further supports Silo’s planned 505(b)(2) regulatory strategy for its SPC-15 program. This regulatory route allows companies to utilize previously established safety and efficacy data (from approved drugs) to potentially streamline the FDA drug approval process and reduce drug development costs.

Silo is currently conducting an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic animal study of SPC-15, and a device study of the formulation-specific microchip-based nasal spray system. The Company is also evaluating potential clinical CRO sites for first-in-human trials.

The post-traumatic stress disorder market size reached a value of $1.8 billion in 2024.¹ Looking forward, the market is expected to reach $3.2 billion by 2034 due to increasing focus on mental health support and the need for personalized treatments and integrated care solutions.²

About Silo Pharma

Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease and multiple sclerosis. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com

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 press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.

Contact

800-705-0120
investors@silopharma.com

¹ IMARC, “Post-Traumatic Stress Disorder Market Size, Epidemiology…”

² BioSpace, “Post-Traumatic Stress Disorder Market Outlook 2024-2034”

FAQ

What were the results of Silo Pharma's (SILO) SPC-15 safety study?

The study showed that SPC-15 intranasal spray demonstrated local and systemic safety with no toxicities at clinical-representative doses, with systemic exposure comparable to standard oral administration.

How is Silo Pharma pursuing FDA approval for SPC-15?

Silo is pursuing approval through the 505(b)(2) pathway, which allows utilization of previously established safety data to potentially streamline the FDA approval process and reduce development costs.

What is the market potential for Silo Pharma's PTSD treatment?

The PTSD market was valued at $1.8 billion in 2024 and is projected to grow to $3.2 billion by 2034, driven by increasing focus on mental health support and personalized treatments.

What are the next steps for Silo Pharma's SPC-15 development?

The company is conducting IND-enabling GLP toxicology studies, performing device studies of the nasal spray system, and evaluating potential clinical CRO sites for first-in-human trials.

What advantages does SPC-15's intranasal delivery offer?

The intranasal nose-to-brain formulation is designed to provide easy administration and rapid absorption while maintaining safety standards comparable to oral delivery.