Silo Pharma Issues Update on Milestone Achievements in PTSD Drug Development and New Digital Assets Treasury Program

Rhea-AI Summary

Silo Pharma (NASDAQ: SILO) reported progress on its lead PTSD candidate SPC-15 and launched a digital assets treasury program. Key biopharma updates include positive bioanalytical and large-animal safety/toxicology results for a 7-day study, completion of an IND-enabling GLP toxicology/toxicokinetic study (data expected in early 2026), finalizing a drug-device study for a microchip-based nasal spray, and patent expansion in the U.S., Australia and Japan. On the crypto side, Silo began purchases in Sept–Oct 2025 (BTC, ETH, SOL, RSC), appointed a lead crypto advisor, formed a crypto advisory board, and engaged Fireblocks for institutional custody and operations.

Catalysts include FDA follow-up in November 2025 and IND submission planning in 2026.

Positive

• Positive bioanalytical and 7-day large-animal safety/toxicology results
• Completed IND-enabling GLP toxicology and toxicokinetic study
• Patent filings expanded to U.S., Australia, and Japan
• Launched digital assets treasury with initial purchases in Sept–Oct 2025
• Engaged Fireblocks for institutional-grade crypto custody and ops

Negative

• IND-enabling study data pending; results expected in early 2026
• FDA follow-up in November 2025 leaves IND timing uncertain for year-end

Insights

Biopharma and Digital Assets Strategist

Silo reports concrete pre‑IND milestones for SPC-15 and has begun building an institutional crypto treasury.

Silo advances its lead intranasal candidate SPC-15 through IND‑enabling work with reported positive large‑animal safety/toxicology results and completion of a GLP toxicology/toxicokinetic study; the company is finalizing a drug‑device combination delivery and expanding patents across major jurisdictions. These steps form the practical pathway to an IND submission and a first‑in‑human Phase 1 trial, pending FDA acceptance.

Progress depends strictly on FDA feedback and the forthcoming GLP data; management notes follow‑up discussions with the FDA in November 2025 and an IND submission planned in 2026. The announcement contains no clinical efficacy data, and the GLP results are not yet released, so regulatory acceptance and trial start remain conditional.

Near‑term items to watch include the FDA discussion in November 2025, publication of the GLP study data expected in early 2026, formal IND acceptance, and CRO selection for first‑in‑human trials; for the treasury program monitor additional digital asset purchases, the composition of the Crypto Advisory Board, and operational onboarding with Fireblocks. Time horizon for these catalysts spans the next 3–12 months.

Significant milestones are approaching in drug development; additional digital asset purchases expected

Preparation for FDA IND application expected to commence before year-end

SARASOTA, FL, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company), a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company, today announced a comprehensive update detailing progress for lead candidate SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety, and key achievements under Silo’s new digital assets treasury platform launched in August 2025.

Biopharmaceutical Platform:

Silo is advancing SPC-15, its lead therapeutic candidate, through the final preparations required
prior to submitting an investigational new drug application (IND) to the FDA. Recent milestones in its drug discovery program include:

• Positive bioanalytical and safety/toxicology results for an FDA-requested 7-day large animal safety study of SPC-15.
• Finalizing drug-device study of the formulation-specific microchip-based nasal spray system used for SPC-15 drug delivery.
• Completion of an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic study of SPC-15. Data is expected in early 2026.
• Global intellectual property expansion with patents for SPC-15 technology in the U.S., Australia, and Japan. Continuing IP expansion is a core element of Silo’s drug development strategy.

Digital Assets Treasury:

Silo launched a digital assets treasury strategy in early August 2025 to participate in the growth and adoption of cryptocurrency and to expand and strengthen the Company’s capital resources. The strategy combines staking for yield with a hedged overlay to reduce volatility in portfolio positions while maintaining upside potential.

• Initial cryptocurrency purchases made in September and October in Bitcoin (BTC), Ethereum (ETH), Solana (SOL), and ResearchCoin (RSC).
• Lead crypto strategy advisor, Corwin Yu, appointed for active management of Silo’s crypto portfolio targeting multi-chain digital asset growth and decentralized finance (DeFi) integration.
• New Crypto Advisory Board, chaired by Corwin Yu, formed to expand Silo’s expert support for cryptocurrency audit and compliance. Two additional members are expected to join before year-end or in early 2026.
• Engaged Fireblocks, an enterprise platform for building blockchain applications and managing digital asset operations, and for providing custody technology services for the institutional crypto treasury platform.

CEO Commentary:

“Our team recently executed a strategic corporate initiative to diversify our operations as both a biopharmaceutical developer and a cryptocurrency treasury company. This expansion is aimed at creating long-term, sustainable stockholder value through treasury growth, asset diversification, and a stronger capital foundation to advance our ongoing drug development programs,” said Eric Weisblum, CEO of Silo.

“Multiple catalysts are on the horizon as we prepare to submit our SPC-15 IND to the FDA. We believe that SPC-15 is well-positioned to proceed into a Phase 1 clinical trial upon FDA approval of our IND, which we plan to submit in 2026. Positive results from the safety/toxicology large animal study further support that SPC-15’s formulation and spray profile will meet the safety standards for clinical trials

Commenting on Silo’s crypto treasury model, Weisblum continued, “We are pleased with our initial achievements under our new crypto strategy. The four investments we’ve made to date underscore our confidence in the continued growth of blockchain technology and the expanding adoption of cryptocurrency as a store of value and medium of exchange. We believe that our digital asset platform is set for success through our engagement with Fireblocks for highly secure institutional-grade infrastructure and crypto technology.”

“Looking ahead, with significant milestones approaching in drug development and additional purchases of leading digital assets, we believe Silo is strategically positioned to drive innovation and capitalize on emerging opportunities.”

Catalysts:

Set forth below are catalysts expected to further Silo’s strategies for its biopharmaceutic platform and digital asset treasury program:

• Data from IND-enabling GLP study is expected in 2026.
• Follow-up conversations with the FDA expected to occur in November 2025 to confirm what management believes are the final data points needed to open an IND before year-end for SPC-15 in PTSD.
• Identify, evaluate, and select clinical research organization (CRO) sites for first-in-human SPC-15 trials.
• Pursue an additional therapeutic indication for SPC-15 to be included in human clinical trials.
• Secure the FDA’s 505(b)(2) accelerated regulatory pathway for clinical development. 
• Advance SP-26 ketamine implant for chronic pain and fibromyalgia.
• Continue strategic purchases of various leading cryptocurrencies and optimize digital asset infrastructure and compliance platforms.
• Participate in the decentralized science (DeSci) Web3 movement, driving transparent, tokenized scientific research in collaboration with ResearchHub.

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

FAQ

What progress did Silo (SILO) report for SPC-15 on October 23, 2025?

Silo reported positive bioanalytical and 7-day large-animal safety/toxicology results, completion of an IND-enabling GLP toxicology/toxicokinetic study, and patent expansion in the U.S., Australia and Japan.

When does Silo expect IND-enabling study data for SPC-15?

The company expects IND-enabling GLP study data in early 2026.

Will Silo submit an IND for SPC-15 in 2025 or 2026?

Silo plans to submit an IND in 2026, with FDA follow-up discussions expected in November 2025 to confirm final data needs.

What cryptocurrencies did Silo purchase for its treasury in Sept–Oct 2025?

Initial purchases included Bitcoin (BTC), Ethereum (ETH), Solana (SOL), and ResearchCoin (RSC).

Who is managing Silo's crypto strategy and infrastructure?

Silo appointed crypto strategy advisor Corwin Yu, formed a crypto advisory board, and engaged Fireblocks for custody and digital asset operations.

What near-term catalysts should investors watch for Silo (SILO)?

Watch for FDA follow-up in November 2025, IND-enabling study data in early 2026, CRO site selection for first-in-human trials, and continued digital asset purchases.