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Theriva Biologics, Inc. (TOVX)·Q3 2025 Earnings Summary

Executive Summary

  • EPS materially beat consensus: Q3 2025 Diluted EPS was ($0.45) versus S&P Global consensus of ($1.13); revenue remains $0.00. This reflects lower-than-expected operating loss in the quarter. Values retrieved from S&P Global.* Actual EPS source *
  • Cash runway extended: Cash and cash equivalents were $7.5M at 9/30/25, increasing to ~$15.5M by early November via ATM sales and a warrant inducement; management now guides runway into Q1 2027 .
  • Clinical momentum: Expanded VIRAGE Phase 2b mPDAC data presented at ESMO showed OS/PFS and DoR improvements for VCN-01 + SoC vs SoC, with greater benefit after two VCN-01 doses; Phase 3 protocol discussions planned with EMA/FDA .
  • Operating discipline: G&A fell 18% YoY in Q3 to $1.9M and R&D fell 7% YoY to $2.6M; a 32% workforce reduction was implemented to focus on regulatory and BD activities .
  • Potential stock catalysts: Upcoming regulatory interactions on Phase 3 PDAC and retinoblastoma programs and partnership efforts for late-stage development and manufacturing scale-up (THERICEL) .

What Went Well and What Went Wrong

What Went Well

  • “Having successully completed the VIRAGE Phase 2b clinical trial, we are now pursuing interactions with the European Medicines Agency and the US FDA to seek alignment on a protocol for a proposed Phase 3 study…” (CEO Steven A. Shallcross) .
  • ESMO expanded mPDAC data showed improved OS, PFS, and DoR for VCN-01 + SoC vs SoC, with persistent bioactivity after repeated dosing; benefits were greater among patients receiving two VCN-01 doses .
  • Cash runway extended into Q1 2027 after ~$6.1M net ATM proceeds in October and ~$4.4M gross warrant-exercise proceeds; runway guidance supported by cost actions and capital raises .

What Went Wrong

  • Ongoing need for additional funding to initiate new VCN-01 clinical trials despite extended runway; management explicitly notes requirement for external capital to start Phase 3 and other studies .
  • Other income fell versus prior year (Q3 other income $79K vs $161K in Q3 2024), reflecting lower interest income; contingent consideration increased expenses during 2025 .
  • Workforce reduction (~32%) underscores resource constraints and focus narrowing; $520K restructuring costs accrued and annual savings expected ~$1.8M .

Financial Results

Income Statement Summary vs prior year, prior quarter, and consensus

MetricQ3 2024Q1 2025Q2 2025Q3 2025Q3 2025 Consensus
Revenue ($USD Millions)$0.00 (no revenue line) $0.00 (no revenue line) $0.00 (no revenue line) $0.00 (no revenue line) $0.00*
Net Loss ($USD Millions)$(7.726) $(4.324) $(13.058) $(4.361) —
Diluted EPS ($)$(6.81) $(1.55) $(1.93) $(0.45) $(1.13)*
Weighted Avg. Shares (MM)1.134 2.782 6.753 9.677 —

Note: Asterisked values are S&P Global consensus; Values retrieved from S&P Global.*

Operating Expenses and cash

MetricQ3 2024Q1 2025Q2 2025Q3 2025
G&A ($USD Millions)$2.302 $1.449 $11.179 $1.889
R&D ($USD Millions)$2.734 $2.968 $1.953 $2.551
Cash & Equivalents ($USD Millions)$11.609 (12/31/24) $10.014 (3/31/25) $12.120 (6/30/25) $7.528 (9/30/25)
Cash runway commentaryRunway into Q3 2025 (FY release) Runway into Q1 2026 Runway into Q1 2026 Runway into Q1 2027 after Oct capital

KPIs (program and financing)

KPIQ1 2025Q2 2025Q3 2025
VIRAGE topline announcedYes (May 7) Ongoing data discussions; expanded ESMO data planned Expanded ESMO data presented; OS/PFS/DoR improvements; two-dose benefit
Workforce reduction (% and timing)——~32% on 9/30/25; $520K charges, ~$1.8M annual savings
Capital raise activity$7.5M gross offering closed May 8; net ~$6.6–$6.9M ATM authorization in June; raised shares; cash at 6/30 $12.1M Oct warrant inducement ($4.4M gross) + ATM (~$6.1M net) lifting cash to ~$15.5M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayCorporateInto Q1 2026 (Q2 release/10-Q) Into Q1 2027 (Q3 8-K/10-Q) Raised
G&A trajectoryFY/Run-rate—Expect G&A to decrease post workforce reduction Lowered
R&D trajectoryNear termQ2: anticipated R&D to increase as VIRAGE completes and Phase 3 planning Q3: anticipate R&D to decrease post VIRAGE completion while focusing regulatory interactions and manufacturing scale-up Lowered
New trial starts (VCN-01)PDAC/RetinoblastomaPreparing Phase 3 protocol; discussions planned Additional funding required to initiate new VCN-01 clinical trials Maintained, with explicit funding caveat

Earnings Call Themes & Trends

Note: No Q3 2025 earnings call transcript was available in our document catalog; the company issued press releases and a 10-Q [ListDocuments returned no transcript]. Themes tracked across quarters:

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
Regulatory pathway (PDAC)FDA/EMA guidance received; Phase 3 design shaping Preparing protocol; End-of-Phase 2 planned Pursuing EMA/FDA alignment on Phase 3 protocol Advancing
Manufacturing scale-up (THERICEL)THERICEL loan funded Jan 2025; manufacturing scale-up noted THERICEL program and ATM funding; manufacturing activities continued Manufacturing scale-up continued; runway supports scale-up Steady progress
Capital strategyMay 8 public offering ($7.5M gross) Cash ~$12.1M; ATM facility active Oct warrant inducement ($4.4M gross) + ATM (~$6.1M net); cash ≈$15.5M Strengthened
VCN-01 clinical efficacy (mPDAC)VIRAGE topline: OS/PFS/DoR improvements; two-dose benefit Expanded data planned at ESMO Expanded ESMO data: mITT/FAS improvements; durability and second-dose bioactivity Reinforced
Cost discipline——Workforce reduction (~32%) and anticipated G&A/R&D decreases Tightening
RetinoblastomaPhase 1 positive; RPDD/Orphan status Program highlighted at ASCO Phase 2/3 design progress for discussion H1 2026 Advancing

Management Commentary

  • “Recent presentations of clinical data for VCN-01 and preclinical data for VCN-12 at medical congresses have highlighted the progress made across our oncology pipeline… With capital raised from our recent warrant inducement and sales made pursuant to our at-the-market (ATM) facility, we are well positioned to advance our regulatory and clinical strategies and explore potential partnerships for the innovative assets in our pipeline.” — Steven A. Shallcross, CEO .
  • ESMO 2025: Expanded VIRAGE data showed improved OS, PFS, and DoR for VCN-01 + SoC vs SoC, with persistent viral genomes measurable for ≥3 months post each dose despite neutralizing antibodies, indicating durable bioactivity .
  • VCN-12 preclinical: Increased cell killing vs VCN-01, higher hyaluronidase activity, and signs of immune-mediated anti-tumor response in animal models; additional studies planned .

Q&A Highlights

  • No Q3 2025 earnings call transcript available in our catalog; the quarter’s communications came via an 8-K press release and 10-Q [ListDocuments returned no earnings-call-transcript]. Guidance clarifications appear in filings and press releases (cash runway, funding needs, cost trajectory) .

Estimates Context

  • EPS: Actual ($0.45) vs consensus ($1.13) → bold beat; revenue estimate $0.00 and actual $0.00. Values retrieved from S&P Global.* Actual EPS source *
MetricQ3 2025 ConsensusQ3 2025 Actual
Primary EPS ($)($1.13)*($0.45)
Revenue ($USD Millions)$0.00*$0.00 (no revenue line)
Primary EPS - # of Estimates1*—
Revenue - # of Estimates1*—
Target Price Consensus Mean ($)7.0*7.0*

Note: Asterisked values are S&P Global consensus; Values retrieved from S&P Global.*

Key Takeaways for Investors

  • EPS beat versus consensus reflects controlled operating loss and lower-than-expected quarterly burn; management also expects lower G&A and R&D going forward post restructuring . Values retrieved from S&P Global.*
  • Cash runway into Q1 2027 reduces near-term financing risk and supports regulatory engagements and manufacturing scale-up; however, Phase 3 trial initiation still requires additional funding or partnership .
  • Clinical data for VCN-01 in mPDAC continue to strengthen (OS/PFS/DoR benefits and repeated-dose bioactivity), enhancing the probability of constructive Phase 3 protocol alignment with regulators .
  • Capital structure improved via October warrant inducement and ATM activity, with ~+$10M proceeds in October contributing to $15.5M cash; watch for dilution risk in future financings .
  • Operating focus tightened (32% workforce reduction) to prioritize regulatory and BD activities; expect opex relief to support runway while the company pursues strategic options .
  • Near-term catalysts: EMA/FDA Phase 3 protocol feedback for PDAC, retinoblastoma Phase 2/3 design progress, and any partnership/manufacturing announcements (THERICEL/AAV platform) .
  • Risk factors: dependent on external capital for registrational studies; contingent consideration adjustments and going-concern disclosures underscore financing sensitivity .

Additional Supporting Data and Notes:

  • Condensed consolidated statements confirm Q3 2025 Net Loss of $(4.361) and EPS of $(0.45); Q2 2025 Net Loss $(13.058) and EPS $(1.93); Q3 2024 Net Loss $(7.726) and EPS $(6.81) .
  • Cash & equivalents at 9/30/25: $7.528M, increased to ~$15.5M by early Nov due to ~$6.1M net ATM and ~$4.0M net warrant inducement proceeds; company guides runway into Q1 2027 .
  • ESMO expanded VIRAGE results show mITT/FAS outcomes: OS 10.6–10.8 months vs 8.6; PFS 5.6–7.0 vs 4.6; DoR 11.2 vs 5.4; and stronger OS/PFS for patients receiving two VCN doses .
  • R&D direct costs by program indicate continued prioritization of VCN-01 with YoY decreases reflecting VIRAGE completion; Q3 2025 direct costs VCN-01 $1.372M .

Values retrieved from S&P Global.*