Silo Pharma announced a new partnership with Allucent, a global full‑service clinical research organization, to prepare and submit an Investigational New Drug (IND) application for its intranasal prophylactic candidate SPC‑15, a therapy aimed at treating post‑traumatic stress disorder (PTSD). The collaboration will focus on designing dose‑range studies, managing regulatory submissions, and coordinating the 505(b)(2) accelerated pathway, with the company targeting an IND filing in 2026 and a Phase 1 trial upon FDA approval.
The choice of the 505(b)(2) pathway reflects Silo’s strategy to leverage existing data and streamline the approval process. By combining SPC‑15’s preclinical safety profile with Allucent’s regulatory expertise, the company aims to reduce development risk and shorten the time to market. The partnership also signals confidence in the intranasal delivery platform, which could offer a more convenient and potentially better-tolerated option for PTSD patients compared to existing oral or injectable therapies.
Financially, Silo remains a developmental‑stage company with a net loss of $1.11 million in Q3 2025, driven largely by research and development expenses. The company’s dual business model—biopharmaceutical development and a cryptocurrency treasury—adds complexity to its financial profile. While the crypto holdings provide a source of liquidity, they also introduce volatility that can affect cash flow and investor perception.
Silo’s decision to engage Allucent follows encouraging preclinical results that demonstrate SPC‑15’s safety and efficacy in animal models of PTSD. The partnership is intended to accelerate the transition from preclinical to clinical testing, positioning the company ahead of competitors in a market that has seen no new PTSD drug approvals in nearly 25 years. By securing a CRO with neuroscience expertise, Silo seeks to mitigate the typical bottlenecks in IND preparation and early clinical development.
CEO Eric Weisblum emphasized the strategic importance of the collaboration, stating, “Partnering with Allucent is a significant step forward in bringing our novel PTSD therapeutic to the clinic. Their expertise in CNS drug development and regulatory strategy will help us navigate the complex IND process and bring SPC‑15 to patients more efficiently.”
The partnership is expected to strengthen Silo’s competitive standing in the PTSD treatment space, potentially opening the door to earlier market entry and increased investor confidence. However, the company’s ongoing net losses and reliance on a cryptocurrency treasury remain headwinds that could impact long‑term financial stability. Nonetheless, the move positions Silo to capitalize on an unmet medical need and could serve as a catalyst for future funding and partnership opportunities.
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