Serina Therapeutics Reports Q3 2025 Loss of $4.6 Million Amid Liquidity Concerns and FDA Clinical Hold

SER
November 14, 2025

Serina Therapeutics reported a net loss of $4.6 million for the quarter ended September 30 2025, translating to a loss per share of $0.45. Operating expenses climbed to $6.4 million, with research and development costs at $3.6 million and general and administrative expenses at $2.7 million. Other income for the period was $1.8 million, a decline from $6.7 million in the same quarter a year earlier. Cash and cash equivalents stood at $8.6 million as of September 30, underscoring the company’s limited liquidity runway.

The loss reflects a deliberate shift toward heavier investment in the company’s POZ platform and its lead Parkinson’s disease candidate SER‑252. R&D spending rose because of outsourced chemistry, manufacturing, and controls work, amortization of a prepaid technology access fee, and increased clinical‑related expenditures. General and administrative costs fell slightly, partly due to reduced compensation‑related expenses but offset by higher investor‑relations spending. Compared with Q3 2024, when Serina posted a net income of $1.4 million, the current quarter’s loss is a reversal of a profitable year, while the Q2 2025 loss of $6.4 million shows a narrowing of the quarterly deficit.

Liquidity remains a critical concern. The $8.6 million cash balance is insufficient to cover operating expenses for more than a few months, and management has disclosed “substantial doubt about the company’s ability to continue as a going‑concern.” The company has secured up to $20 million in convertible note financing, of which $5 million has been drawn, and an at‑the‑market program has generated $2.8 million in net proceeds as of early November. These measures provide a short‑term buffer but do not eliminate the need for additional capital to fund ongoing clinical development.

On November 3, the FDA placed a clinical hold on the IND for SER‑252, citing a request for additional information regarding a formulation excipient. The hold does not affect the active drug substance but delays the company’s ability to advance the candidate into the clinic. Management has emphasized that the hold is procedural and that the company is working to resolve the issue, but the event adds to the company’s regulatory risk profile and underscores the urgency of securing further funding.

CEO Steve Ledger highlighted both progress and caution in his comments. He noted that the POZ platform continues to enable differentiated, long‑acting therapies across neurological conditions and that the company remains focused on reaching key milestones, including dosing the first patient in the Phase 1b trial of SER‑252 by the fourth quarter. At the same time, he acknowledged the liquidity constraints and the need for additional capital to sustain operations and support the pipeline’s advancement.

The combination of a heavy R&D spend, a regulatory hold, and a limited cash position creates a challenging near‑term environment for Serina. Headwinds include the clinical hold, the company’s going‑concern warning, and the need for substantial capital to maintain operations. Tailwinds are the continued development of SER‑252 and SER‑270, the potential for a 505(b)(2) pathway for SER‑252, and the company’s proprietary POZ platform, which could differentiate its products in a high‑unmet‑need market. Investors will likely focus on the company’s ability to resolve the regulatory hold, secure additional financing, and achieve the next clinical milestones before the cash runway expires.

The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.