Silo Pharma Reports Positive Stability Data for SPC-15 PTSD Treatment, Advancing Program Toward First-in-Human Clinical Trial

Silo Pharma (Nasdaq:SILO) reported positive stability data for its investigational PTSD prophylactic treatment SPC-15, a soft-mist intranasal formulation.

Rhea-AI Summary

Silo Pharma (Nasdaq:SILO) reported positive stability data for its investigational PTSD prophylactic treatment SPC-15, a soft-mist intranasal formulation. Real-time data over nine months and six-month accelerated testing showed physical, chemical and microbiological stability within predefined specifications, supporting IND-enabling CMC requirements and advancement toward a first-in-human Phase 1 clinical trial.

Positive

• Nine-month real-time stability confirmed for SPC-15 formulation and device
• Six-month accelerated stability data aligned with long-term results
• Stability within predefined specs for assay, impurities, pH, microbiological quality
• Key device spray performance remained on trend over nine months
• Data support IND-enabling CMC package for planned Phase 1 trial
• Milestone achieved under cGMP-aligned manufacturing standards

Negative

• None.

Argus Jun 23 session

+3.74% close to close Open Argus

Details

News Market Reaction – SILO

On Jun 23, the day this news came out, SILO closed 3.74% above the previous close.

Data tracked by StockTitan Argus for the Jun 23 session.

Key Figures

Real-time stability duration: 9 months Accelerated stability duration: 6 months Device performance trend: Within predefined specs

Real-time stability duration

9 months

SPC-15 physical, chemical, microbiological stability under long-term conditions

Accelerated stability duration

6 months

SPC-15 stability under accelerated storage conditions

Device performance trend

Within predefined specs

Key spray performance tests for SPC-15 intranasal device

Previous Clinical trial Reports

4 past events · Latest: Dec 30

Same Type 4 events

1. Dec 30

   Phase 1 planning

   24h Move

   +4.7%

   LOI with Allucent to support SPC-15 Phase 1 clinical development.

2. Aug 19

   Preclinical safety data

   24h Move

   -6.5%

   Positive 7-day large animal safety study for SPC-15 under 505(b)(2) path.

3. Jun 11

   Biomarker patent

   24h Move

   +0.5%

   USPTO biomarker patent allowance strengthening SPC-15 PTSD IP position.

4. Jan 08

   PTSD patent award

   24h Move

   +56.9%

   Notice of Allowance for key PTSD prophylactic patent protecting SPC-15.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational new drug (ind), chemistry, manufacturing, and controls (cmc), current good manufacturing practice (cgmp), intranasal

4 terms

investigational new drug (ind) regulatory

"requirements for investigational new drug (IND)-enabling chemistry, manufacturing"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

chemistry, manufacturing, and controls (cmc) regulatory

"IND)-enabling chemistry, manufacturing, and controls (CMC) documentation."

Chemistry, manufacturing, and controls (CMC) is the collection of information and data that describes a drug’s recipe, how it is made at scale, and the quality checks that ensure each batch is consistent and safe. For investors, CMC matters because regulators use it to decide approvals and manufacturing reliability; weak or incomplete CMC can delay launches, raise production costs, or create supply risks much like a flawed recipe or factory process undermines a product’s reliability.

current good manufacturing practice (cgmp) regulatory

"milestone validates our adherence to current Good Manufacturing Practice (cGMP)"

Current good manufacturing practice (cGMP) are regulatory rules that require drug, medical device, and certain food makers to follow up-to-date standards for production, quality control, cleanliness, documentation, and staff training so products are consistently safe and effective. For investors, cGMP compliance is like a company passing routine safety inspections: it lowers the risk of costly recalls, regulatory fines, and production shutdowns, and supports steady revenue and preserved company value.

intranasal medical

"investigational soft-mist intranasal prophylactic, SPC-15, through nine months"

Administration or delivery of a drug or vaccine through the nose, typically via a spray or drops that are absorbed by the nasal tissues. For investors, intranasal products can matter because they often offer easier, needle-free use, faster onset of effect, and potential cost or compliance advantages that can widen a product’s market and affect regulatory review, manufacturing complexity, and commercial prospects — similar to how a convenient app can outsell a clunky desktop program.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Positive data supports the continued advancement of FDA Investigational New Drug (IND)- enabling development program

SARASOTA, FLA., June 23, 2026 (GLOBE NEWSWIRE) -- Silo Pharma (Nasdaq: SILO) (“Silo” or “the Company”), a developmental-stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has confirmed the physical, chemical and microbiological stability of its investigational soft-mist intranasal prophylactic, SPC-15, through nine months of real-time testing. The stability data demonstrates that SPC-15’s formulation maintains physical, chemical, and microbiological integrity over nine months at long term and six months at accelerated conditions.

The stability program was conducted under long-term and accelerated storage conditions aligned
with requirements for investigational new drug (IND)-enabling chemistry, manufacturing, and controls (CMC) documentation. Data showed that SPC-15’s formulation and device remained within predefined specifications for assay, impurities, pH, and microbiological quality through nine months, and the product remained in trend for predefined key device spray performance tests. Six-month accelerated stability data was consistent and aligned with long term data.

“The positive stability data support continued advancement of our IND-enabling development program and contribute to the manufacturing information required in an IND submission for a first-in-human Phase 1 clinical study,” said Eric Weisblum, CEO of Silo Pharma. “This important milestone validates our adherence to current Good Manufacturing Practice (cGMP) standards.”

About SPC-15

SPC-15 is an investigational intranasal serotonin 5-HT4 receptor agonist being developed by Silo Pharma for stress-induced psychiatric conditions, primarily post-traumatic stress disorder (PTSD) and anxiety, using a special soft mist nasal spray delivery system for fast brain action. It's in preclinical stages, partnering with Columbia University, and aims for an accelerated FDA approval pathway (505(b)(2)) by leveraging biomarkers and novel delivery

About Silo Pharma, Inc.
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. 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 the Company to differ materially from the results expressed or implied by such statements, including statements about the intended use of proceeds from the offering, 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What stability results did Silo Pharma (SILO) report for its SPC-15 PTSD treatment?

Silo Pharma reported that SPC-15 maintained physical, chemical and microbiological stability through nine months of real-time testing. According to Silo Pharma, both formulation and device stayed within predefined specifications, with six-month accelerated data consistent with long-term results, supporting continued development of the program.

How do SPC-15 stability data advance Silo Pharma (SILO) toward a Phase 1 clinical trial?

The stability data provide key chemistry, manufacturing and controls information needed for an IND submission. According to Silo Pharma, these findings support the IND-enabling development program for SPC-15 and help advance the PTSD prophylactic treatment toward a first-in-human Phase 1 clinical study.

What testing conditions were used to evaluate SPC-15 stability at Silo Pharma (SILO)?

SPC-15 was evaluated under long-term and accelerated storage conditions aligned with IND-enabling CMC requirements. According to Silo Pharma, nine-month long-term and six-month accelerated testing confirmed the product stayed within specifications for assay, impurities, pH, microbiological quality and key device spray performance metrics.

Why are the SPC-15 stability results important for Silo Pharma (SILO) investors?

The stability results mark a key development milestone for SPC-15’s clinical path. According to Silo Pharma, these data strengthen the manufacturing package required for an FDA IND application, supporting progression toward a first-in-human Phase 1 trial in PTSD, which may impact future value creation.

How does Silo Pharma (SILO) describe SPC-15 and its intended use?

SPC-15 is described as an investigational soft-mist intranasal prophylactic for PTSD. According to Silo Pharma, the current work focuses on IND-enabling chemistry, manufacturing, and controls, including confirming that the formulation and delivery device meet predefined stability and performance specifications over time.