Silo Pharma entered into a non‑binding Letter of Intent with Allucent (US) LLC to provide clinical research services for two planned Phase 1 studies of its intranasal serotonin 5‑HT4 agonist SPC‑15. The studies will comprise an Open‑Label, Single Ascending Dose (SAD) and an Open‑Label, Multiple Ascending Dose (MAD) trial in healthy volunteers, covering all safety and pharmacokinetic endpoints required for an IND submission.
The LOI marks the first formal step to move SPC‑15 from pre‑clinical into early human testing, a critical milestone for a company whose lead candidate targets post‑traumatic stress disorder and anxiety. Allucent’s global CRO expertise is expected to accelerate data generation and support an IND filing, which Silo had previously targeted for 2025 but has now shifted to 2026. The agreement will lead to a Master Services Agreement and a project‑specific Work Order covering clinical operations, pharmacovigilance, data management, biostatistics, clinical pharmacology modeling, and medical writing.
The announcement follows a November 17, 2025 disclosure in which Silo selected Allucent to support final IND preparations, indicating continuity in the partnership. The LOI includes proposed payment terms—an upfront fee for direct service fees and pass‑through costs—though specific amounts are not disclosed. The LOI is non‑binding, but it signals that the parties are moving toward a definitive agreement that will formalize the scope and budget of the Phase 1 program.
Investors reacted by a decline in Silo’s share price, falling 8.3% to $0.334, reflecting that the market viewed the LOI as a procedural update rather than a substantive breakthrough. The decline also underscores ongoing concerns about the company’s financial health and its Nasdaq compliance extension through June 2026, as the stock trades near a 52‑week low.
CEO Eric Weisblum said the LOI “could lead to a meaningful step forward in advancing SPC‑15 into Phase 1 clinical development,” emphasizing the company’s focus on efficient data generation and regulatory progress. Weisblum noted that the partnership aligns with Silo’s strategy to leverage external expertise to mitigate development risk and cost.
While the LOI does not provide a definitive IND submission date, it signals that Silo is moving toward regulatory filing and that the company is actively pursuing external CRO partners to support its early‑stage clinical program. The partnership is a strategic move to accelerate the timeline for SPC‑15’s regulatory submission and to strengthen the company’s pipeline amid financial challenges.
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