Sign in

You're signed outSign in or to get full access.

ST

Serina Therapeutics, Inc. (SER)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered a narrower loss than consensus, with EPS of $-0.45 vs Wall Street at $-0.53, a beat of $0.08; revenues were $0, in line with expectations . EPS consensus and count: $-0.53 (2 estimates)*.
  • Operating expenses rose year over year as R&D ramped for SER-252 and SER-270, while G&A declined slightly; other income was positive but far below the prior-year warrant-related gain .
  • Regulatory trajectory shifted: FDA aligned with a 505(b)(2) NDA path and recognized SER-252 Phase 1b as registrational, but placed a clinical hold on Nov 3 pending excipient information; management expects formal communication within 30 days and is actively addressing questions .
  • Liquidity strengthened via a $5M tranche drawn in October under an up to $20M convertible note program and incremental ATM proceeds; cash ended Q3 at $8.6M, supporting near-term trial initiation plans .

What Went Well and What Went Wrong

What Went Well

  • FDA alignment on the 505(b)(2) path and recognition of Phase 1b as registrational represents a key milestone: “This outcome underscores our regulatory and development strategy, positioning SER-252 for an accelerated path to potential approval” — CEO Steve Ledger .
  • Funding flexibility improved: Company accessed the first $5M tranche under the up to $20M facility to advance SER-252 and added ~$2.8M net via the ATM, bolstering the balance sheet ahead of trial start .
  • Pipeline progress: SER-270 continued toward pre-IND in 2026, broadening neurological focus and optionality across POZ-enabled therapies .

What Went Wrong

  • FDA clinical hold (Nov 3) on the SER-252 IND pending excipient information delays the U.S. start; hold is not related to active drug substance or mechanism, but introduces timing uncertainty .
  • Year-over-year net result deteriorated as the warrant-related other income tailwind in Q3 2024 normalized; other income in Q3 2025 was $1.8M vs $6.7M in Q3 2024, driving a shift from +$1.4M net income to a $4.6M net loss .
  • Operating expenses stepped up with R&D intensity; total OpEx rose to $6.4M (+$1.1M YoY) as outsourced research, CMC consulting, amortization of technology access fees, and clinical-related spend increased .

Financial Results

Income Statement and Liquidity (comparisons vs prior year and prior quarter)

MetricQ3 2024Q2 2025Q3 2025
Total Revenues ($USD Thousands)$14 $130 $0
Research & Development ($USD Thousands)$2,415 $3,152 $3,651
General & Administrative ($USD Thousands)$2,911 $2,543 $2,741
Total Operating Expenses ($USD Thousands)$5,326 $5,695 $6,392
Other Income (Expense), Net ($USD Thousands)$6,695 $(897) $1,797
Net (Loss) Income ($USD Thousands)$1,383 $(6,462) $(4,595)
EPS – Basic ($USD)$0.16 $(0.66) $(0.45)
EPS – Diluted ($USD)$0.13 $(0.66) $(0.45)
Cash and Equivalents (Period End, $USD Thousands)$3,235 $6,041 $8,620

Notes:

  • EPS beat versus consensus: Q3 2025 actual $-0.45 vs $-0.53 consensus, beat of $0.08 (see Estimates Context below) . EPS consensus and counts are from S&P Global*.

Operating Detail and Share Metrics

MetricQ3 2024Q2 2025Q3 2025
Weighted Avg Shares – Basic (Millions)8.851 10.004 10.339
Weighted Avg Shares – Diluted (Millions)10.751 10.004 10.339
Warrant Liability – Current ($USD Thousands)——$1,676
Warrant Liability – Non-Current ($USD Thousands)$3,582 $3,549 $1,882
Net Cash Used in Operating Activities (YTD, $USD Thousands)$(12,548) (9M 2024) $(8,072) (6M 2025) $(11,922) (9M 2025)

KPIs commentary:

  • Other income in Q3 2025 reflects $1,044 change in fair value of warrants and $724 gain on warrants expiration; these non-operating items materially affect quarterly EPS volatility .
  • Cash increased sequentially due to financing inflows (convertible note tranche and ATM sales) despite operating cash burn .

Estimates vs Actuals (Q3 2025)

MetricConsensusActualSurprise
EPS (Primary, $USD)$-0.53*$-0.45 Beat by $0.08
Revenue ($USD Millions)$0.00*$0.00 In line

Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
SER-252 Regulatory Path2025Prepare for Phase 1b start in Q4 2025 FDA supports 505(b)(2) NDA path; Phase 1b recognized as registrational. IND placed on clinical hold Nov 3 pending excipient info; formal FDA communication expected within 30 days Mixed: Recognition (positive) and clinical hold (delay)
SER-252 Trial InitiationQ4 2025On track for Q4 2025 initiation IND submitted; HREC approval in Australia; global initiation planned in Q4 2025, first dosing targeted before year-end Maintained trajectory ex-U.S.; U.S. timing contingent on resolving hold
Funding Capacity2025-2026$5M equity (Apr 2025); exploring ATM Up to $20M convertible note with $5M first tranche drawn; additional tranches tied to patient milestones; 100% warrant coverage Raised
ATM Program2025ATM capacity up to $13.3M; $1.2M net proceeds through Aug 8 474,712 shares sold at ~$6.00; ~$2.8M net proceeds as of Nov 7 Raised
Cash Runway2025Cash projected to fund operations through Q3 2025 (Q1) and into Q4 2025 (Q2) Cash $8.6M at Q3 end; incremental financing in place; no explicit runway update Maintained flexibility; formal runway not reiterated

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was available in the document catalog; management themes below reflect press releases and 8-Ks.

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
Regulatory/Clinical Path (SER-252)On track for first patient dosing in Phase 1b in Q4 2025 Continued momentum; Phase 1b planned in 2025 FDA supports 505(b)(2) NDA; Phase 1b recognized as registrational; IND on clinical hold pending excipient info Positive strategic alignment; near-term U.S. timing risk
International Trial Execution—Global program design referenced HREC approval in Australia; plan to begin ex-U.S. sites Q4 2025 Advancing outside U.S.
Funding and Capital Strategy$15M equity since late 2024; $5M private placement in April 2025 ATM launched; $1.2M net proceeds by Aug 8 Up to $20M convertible note; $5M drawn; ATM proceeds grew to $2.8M Strengthened
Platform and Pipeline (POZ, SER-270)Presented POZ-lipid immune profile data; broadened modalities Advanced SER-270; board additions to bolster neuroscience expertise SER-270 on track for formulation optimization and pre-IND in 2026 Steady progress
Stakeholder Communications——Corporate communications platform launched to enhance engagement Enhanced outreach

Management Commentary

  • “The FDA's alignment with our plan to advance SER-252 under a 505(b)(2) NDA pathway, and its recognition of the Phase 1b trial as registrational, represents a key milestone for Serina…positioning SER-252 for an accelerated path to potential approval.” — Steve Ledger, CEO .
  • “This financing provides the resources to advance SER-252 through critical clinical milestones…while maintaining flexibility to access additional non-dilutive and strategic funding.” — Steve Ledger, CEO .
  • “We are pleased to have filed the IND and to be progressing on schedule toward initiating the study in the current quarter.” — Steve Ledger, CEO .

Q&A Highlights

  • No Q3 2025 earnings call transcript was available; the company may not have held a call or has not published a transcript in the period searched.
  • Guidance clarifications via press releases: IND submitted; HREC approval obtained; FDA clinical hold specific to excipient information and does not relate to active drug or mechanism .
  • Financing structure details: multi-tranche milestones, convertibility at $5.18, 10% annual interest (after year one), warrant coverage at $5.44 with defined expiry tied to trial milestones .

Estimates Context

  • EPS: Q3 2025 EPS of $-0.45 beat consensus $-0.53; two estimates contributed to consensus.* Actual EPS from filings .
  • Revenue: Consensus was $0.00, matching reported $0.00, reflecting clinical-stage status with no product revenue.*

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • The quarter’s EPS beat was driven by moderate positive other income and controlled G&A, partially offsetting higher R&D; warrant-related mark-to-market remains a key non-operating swing factor .
  • Regulatory risk emerged with the FDA clinical hold on SER-252 IND; near-term U.S. timing depends on resolving excipient questions, but ex-U.S. sites remain positioned to initiate in Q4 .
  • Capital position improved: $5M tranche drawn and ATM proceeds of ~$2.8M; liquidity at $8.6M supports immediate trial initiation needs, with additional tranches contingent on enrollment milestones .
  • Strategic validation: 505(b)(2) path and registrational designation could enable a capital-efficient approval route, a potential valuation inflection if timelines normalize .
  • Watch for catalysts: FDA formal communication on the hold (within ~30 days of Nov 3), first patient dosing (Australia) in Q4, and subsequent tranche unlocks tied to enrollment .
  • Pipeline breadth: SER-270 progressing toward pre-IND in 2026 adds optionality; continued platform partnering (e.g., Pfizer POZ polymer license) provides non-dilutive opportunities .
  • Trading implications: Expect heightened headline sensitivity around hold resolution and trial initiation; funding milestones and ATM activity may influence float and volatility near catalysts .