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Phio Pharmaceuticals Corp. (PHIO)·Q3 2025 Earnings Summary

Executive Summary

  • EPS of $0.44 loss beat Wall Street consensus of $0.45 loss by $0.01, driven by interest income partially offsetting higher OpEx . EPS consensus from S&P Global was -$0.45*.
  • Phase 1b PH-762 reached the fifth and final cohort at maximum dose; pathology showed 100% tumor clearance in one patient and strong responses across all three maximum-dose patients, with no dose-limiting toxicities reported .
  • Warrant inducement financing of ~$12.1 million in November extended estimated cash runway into the first half of 2027; cash and equivalents were ~$10.7 million at quarter-end and ~$21.3 million as of the release date .
  • Safety Monitoring Committee issued a favorable review at maximum dose, reinforcing the tolerability profile of PH-762 and supporting continued screening/treatment in the final cohort .

What Went Well and What Went Wrong

  • What Went Well

    • Clinical efficacy at maximum dose: “Positive Pathology Results at Maximum Dose: 100% Tumor Clearance (Complete Response) in One Patient, Greater than 90% (Near Complete Response) in Second Patient, Greater than 50% (Partial Response) in Third Patient” .
    • Safety: “There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects… PH-762 has been well tolerated in all enrolled patients” .
    • Liquidity/runway: “Warrant Inducement Financing in November 2025 for Expected Net Proceeds Totaling Approximately $12.1 million, Extending Cash Runway into First Half 2027” .

  • What Went Wrong

    • Higher operating expenses widened the loss: R&D rose to $1.181M vs $0.644M YoY and G&A rose to $1.324M vs $0.946M YoY; net loss increased to $2.392M vs $1.524M YoY .
    • Continued reliance on external financing and warrant inducements (new warrants to purchase up to 11,326,364 shares at $2.05) implies potential dilution risk for equity holders .
    • No product revenue reported; the company remains pre-commercial with operations funded by cash and financing activities .

Financial Results

P&L and Cash Trends

MetricQ1 2025Q2 2025Q3 2025
Research and Development ($USD Thousands)$886 $1,074 $1,181
General and Administrative ($USD Thousands)$986 $1,235 $1,324
Total Operating Expenses ($USD Thousands)$1,872 $2,309 $2,505
Net Loss ($USD Thousands)$(1,769) $(2,166) $(2,392)
Diluted EPS ($USD)$(0.41) $(0.45) $(0.44)
Cash and Equivalents at Period End ($USD Thousands)$13,278 $10,775 $10,705

YoY Comparison (Q3 2025 vs Q3 2024)

MetricQ3 2024Q3 2025
Research and Development ($USD Thousands)$644 $1,181
General and Administrative ($USD Thousands)$946 $1,324
Total Operating Expenses ($USD Thousands)$1,590 $2,505
Net Loss ($USD Thousands)$(1,524) $(2,392)
Diluted EPS ($USD)$(1.54) $(0.44)

Estimates vs Actuals

MetricQ2 2025 ConsensusQ2 2025 ActualQ3 2025 ConsensusQ3 2025 Actual
EPS ($USD)$(0.36)*$(0.45) $(0.45)*$(0.44)
Revenue ($USD Millions)$0.00*Not disclosed $0.00*Not disclosed

Estimates marked with * are values retrieved from S&P Global.

Clinical KPIs (PH-762 Phase 1b)

KPIResultPeriod/Context
Fifth cohort maximum-dose pathology (3 pts)1 CR (100%), 1 near-CR (>90%), 1 PR (>50%) Day 36 after initial injection
Cumulative cSCC pathology (16 pts)6 CR, 2 near-CR, 2 PR, 6 non-response; no clinical progression reported Across five dose-escalation cohorts
Safety summaryNo dose-limiting toxicities; PH-762 well tolerated Across all cohorts

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayAs of Q1 2025Sufficient capital to complete the treatment phase of Phase 1b trial Estimated runway into the first half of 2027 Raised/Extended
Phase 1b EnrollmentQ1 → Q3 2025Expected to complete enrollment in Q3 2025 Fifth and final cohort at max dose; may continue screening/treating additional patients Maintained/Ongoing
Manufacturing Readiness2025—cGMP drug substance development services agreement in place for PH-762 New/Operational
Financing2025—July warrant inducement ($2.1–$2.2M net) and November inducement ($12.1M expected) New capital inflows

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
PH-762 clinical efficacy4 CRs, 1 near-CR, 1 PR in early cohorts; no clinical progression 5 CRs, 1 near-CR, 1 PR; adding patients, well tolerated Max dose: 1 CR, 1 near-CR, 1 PR; cumulative 6 CR in cSCC; well tolerated Strengthening efficacy signals
Safety/tolerabilityNo DLTs reported No DLTs; well tolerated No DLTs; favorable safety review by committee Consistently favorable
Manufacturing readiness—Entered drug substance development services agreement (cGMP) Agreement detailed; ongoing process development and cGMP manufacture Operational execution
Financing/liquidity~$9.2M raised in Dec–Jan; cash $13.3M at Q1-end July warrant inducement (~$2.2M net); cash $10.8M at Q2-end November inducement (~$12.1M expected); runway into H1’27; cash $10.7M at Q3-end and ~$21.3M as of release Runway extended
Regulatory/Scientific visibilityAAD/SID, ITOC presentations SID/ASCO presentations Wainwright, Life Sciences PA, Renmark, SITC, Advanced Therapies USA presentations Broader outreach

Management Commentary

  • “Clinical trial has advanced to Fifth and Final Cohort at Maximum Dose of INSTASYL PH-762 in Skin Cancer Trial” .
  • “Safety Monitoring Committee Issues Favorable Review of Safety Data at Maximum Dose of INTASYL PH-762” .
  • “Warrant Inducement Financing in November 2025 for Expected Net Proceeds Totaling Approximately $12.1 million, Extending Cash Runway into First Half 2027” .
  • PH-762 trial design and indications: neoadjuvant intratumoral dosing in cSCC, melanoma, and Merkel cell carcinoma with pathology assessment on day 36 .

Q&A Highlights

  • Not applicable; no Q3 2025 earnings call transcript was available. Management updates were provided via the earnings press release .

Estimates Context

  • EPS: Q3 2025 EPS came in at $(0.44), modestly better than consensus $(0.45), a $0.01 beat, supported by interest income offsetting higher OpEx; number of estimates: 2* .
  • Revenue: Consensus expected $0.00, consistent with the company reporting no product revenue in its quarterly materials* .
  • Model implications: Continued R&D ramp (1.181M) and G&A step-up (1.324M) suggest upward revisions to OpEx run-rate; liquidity extension into H1’27 reduces near-term financing risk .

Estimates marked with * are values retrieved from S&P Global.

Key Takeaways for Investors

  • PH-762 efficacy signal strengthened at the maximum dose, with 1 CR, 1 near-CR, and 1 PR at day 36 and no clinical progression across treated patients, supporting advancement into later-stage development .
  • Safety profile remains favorable with no DLTs and a positive safety committee review, de-risking dose-escalation and enabling broader patient screening at the final cohort .
  • Liquidity significantly improved via November warrant inducement (~$12.1M expected), extending runway into H1’27—a key reduction in financing overhang .
  • Q3 operating expenses rose sequentially and YoY (OpEx $2.505M), widening net loss to $(2.392) despite modest interest income; watch OpEx trajectory as manufacturing and clinical activities scale .
  • EPS beat vs consensus was small but positive; with no reported revenue, catalysts hinge on clinical readouts, manufacturing progress, and regulatory interactions rather than near-term commercial metrics .
  • Near-term trading: Expect sentiment tied to further fifth-cohort updates and any SITC/Advanced Therapies follow-on visibility; financing terms and dilution remain a watch item .
  • Medium-term thesis: If PH-762 efficacy and safety are consistently replicated and manufacturing readiness stays on track, the program may present a non-surgical option in skin cancers, potentially unlocking partnering or accelerated pathways .