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LP

Lantern Pharma Inc. (LTRN)·Q3 2025 Earnings Summary

Executive Summary

  • Lantern Pharma delivered a “transformational” quarter anchored by LP-184 Phase 1a clinical validation (48% clinical benefit at or above therapeutic dose) and FDA Type C regulatory clarity for the pediatric CNS program, while maintaining disciplined cash management with $12.4M in cash, cash equivalents and marketable securities as of September 30, 2025 .
  • Q3 EPS was a beat: -$0.39 vs Wall Street consensus of -$0.47; revenue remains de minimis (no product revenue reported) and S&P Global consensus data*.
  • Operating expenses fell to $4.35M from $4.65M in Q2 and $5.18M in Q3’24, reflecting R&D cost reductions despite higher G&A; net loss improved to $4.18M vs $4.33M in Q2 and $4.51M in Q3’24 .
  • Near-term catalysts include a KOL webinar (Nov 20, 2025) on LP-184, December LP-300 clinical data updates, and 2026 trial initiations (LP-184 Phase 1b/2, pediatric CNS) — potential stock reaction drivers, balanced by management’s explicit statement that “we will need substantial additional funding” and ongoing ATM usage .

What Went Well and What Went Wrong

What Went Well

  • LP-184 Phase 1a achieved all primary endpoints, with clinical benefit in 48% of evaluable patients at or above the therapeutic dose threshold; marked tumor reductions were observed in DDR-mutated tumors (CHK2, ATM, BRCA1, STK11/KEAP1) validating RADR-guided precision strategy .
    Quote: “The observed 48% clinical benefit rate…validates our AI-driven, precision medicine approach” — Panna Sharma, CEO .
  • FDA Type C meeting provided regulatory pathway clarity for pediatric CNS cancer (ATRT), confirming a spironolactone combination strategy and supportive trial design feedback for Starlight Therapeutics .
  • AI platform momentum: predictBBB.ai (94.1% BBB prediction accuracy) and LBx-AI modules showcased commercial readiness, with top-11 leaderboard placements and new collaborations; multi-agentic “Zeta” rare-cancer platform rollout planned .

What Went Wrong

  • Funding needs: management noted “we will need substantial additional funding in the near future,” highlighting financing risk despite runway into ~Q3 2026; ATM sales totaled ~$1.62M through Nov 13 .
  • G&A increased to ~$1.9M (vs ~$1.5M in Q3’24) on BD/IR and professional fees even as R&D declined; overall net loss remains ~$4.2M for the quarter .
  • Timelines slipped: several trial initiations shifted into early 2026 (LP-184 Phase 1b/2, pediatric CNS; investigator-led bladder) from prior 2025 expectations, introducing execution timing risk .

Financial Results

P&L, EPS, Operating Expenses, and Cash

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Net Loss ($USD Millions)$4.51 $4.54*$4.33 $4.18
Diluted EPS ($USD)-$0.42 -$0.42 -$0.40 -$0.39
Total Operating Expenses ($USD Millions)$5.18 $4.77*$4.65 $4.35
Cash and Equivalents ($USD Millions)$7.51 $6.38*$6.06 $8.39
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$24.00 $19.70 $15.90 $12.40

Values marked with * retrieved from S&P Global.

R&D and G&A Expenses (Quarterly)

MetricQ3 2024Q1 2025Q2 2025Q3 2025
R&D Expense ($USD Millions)$3.72 ~$3.30 $3.07 $2.44
G&A Expense ($USD Millions)$1.46 ~$1.50 $1.58 $1.91

EPS and Revenue vs. Consensus (Q3 2025)

MetricActualConsensusSurprise
EPS ($USD)-$0.39 -$0.47*+$0.08 (beat)
Revenue ($USD Millions)~0.00 0.00*In-line

Values marked with * retrieved from S&P Global.

Segment breakdown: Not applicable; company has no commercial revenue segments .

KPIs (selected)

  • Shares outstanding: ~11.04M (as of Sep 30, 2025) .
  • Options outstanding: ~1.22M at $5.74 WAEP; no warrants outstanding .
  • Operating runway: into approximately Q3 2026 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayFY 2026“at least into June 2026” (as of Q2’25) “into approximately Q3 2026” (as of Q3’25) Raised/Extended
LP-300 data updateQ3/Q4 2025“anticipated in September 2025” “December 2025 interim patient follow-up and clinical data” Shifted later
LP-184 KOL webinarQ4 2025Not specifiedNov 20, 2025 at 4:30 p.m. ET New event
LP-184 Phase 1b/2 initiationEarly 2026“anticipated to begin late 2025, subject to funding” “planned Q1 2026, subject to funding” Delayed
Pediatric CNS trial initiation (Starlight)Early 2026“late 2025 anticipated, subject to funding” “planned Q1 2026 (IND amendment submission)” Delayed
Investigator-led bladder trial (Denmark)2026“planned to begin in Q3 2025” “H1 2026 planned initiation in Denmark” Delayed

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
AI commercialization (predictBBB, LBx-AI)PredictBBB launched; combo prediction module; public module plans 94.1% BBB accuracy; LBx-AI at 86–90% NSCLC response prediction; broader rollout; “Zeta” rare-cancer co-scientist announced Accelerating
LP-184 clinical validationEnrollment completed; RP2D established; FDA cleared TNBC and NSCLC biomarker protocols Phase 1a met endpoints; 48% benefit; biomarker-driven tumor reductions; KOL webinar set Strong validation
Regulatory progress (Type C, Fast Track)IND clearances for TNBC and NSCLC biomarker trials; Fast Track GBM/TNBC; pediatric designations FDA Type C meeting clarity for ATRT; spironolactone combo affirmed Positive momentum
LP-300 HARMONIC trialComplete response; Asian expansion; September data anticipated Japan cohort complete; CRO transition for cost efficiency; December data update Operational progress; timeline shift
LP-284 lymphoma programFirst complete metabolic response; IP strengthened DLBCL complete metabolic response reiterated; site recruitment; combo opportunities; autoimmune exploration Expanding scope
Capital and runway~$19.7M (Q1), ~$15.9M (Q2) cash + securities; call strategy changes ~$12.4M cash + securities; runway into ~Q3 2026; ATM usage Runway extended; financing still needed

Management Commentary

  • Strategic message: “The observed 48% clinical benefit rate…validates our AI-driven, precision medicine approach and positions us to advance multiple planned high-value Phase 1b/2 trials” — Panna Sharma (CEO) .
  • RADR commercialization: “We showcased…deployable, highly scalable, web‑accessible AI tools…important step to monetize the technology” — CEO .
  • Funding and runway: “We believe our cash…will enable us to fund…into approximately Q3 2026…We will need substantial additional funding in the near future” — David Margrave (CFO) .
  • Pipeline focus: LP-184 targeted Phase 1b/2 in TNBC, NSCLC with KEAP1/STK11, bladder, first recurrent GBM — combined market >$7B .
  • LP-300: 86% clinical benefit to date; December webinar for interim readout .
  • LP-284: Complete metabolic response in heavily pretreated DLBCL; exploring autoimmune indications; patents through 2039 .

Q&A Highlights

  • LP-300 interim event timing: Not at 31 events by December; tracking early 2026 — “positive” as patients remain longer on therapy; December webinar will present added follow-up data .
  • Denmark bladder trial: IRB approved; expected start late December or early January; investigator-led .
  • Pediatric CNS program: IND submission “in the next few weeks”; initial dosing expected early 2026 .
  • “Zeta” rollout: Select demos to collaborators in December; broader rollout Jan–Feb 2026; internally already in use .

Estimates Context

  • Q3 2025 EPS: Actual -$0.39 vs consensus -$0.47 (beat of $0.08); single estimate coverage and S&P Global*.
  • Q3 2025 revenue: In-line at ~$0 vs consensus $0; consensus coverage two estimates*.
  • Implication: With ongoing non-revenue R&D stage and opex reductions, EPS volatility remains primarily driven by operating expense mix rather than top line; future estimate revisions likely hinge on trial initiations, data updates, and financing clarity.

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • LP-184’s Phase 1a biomarker-driven validation (48% benefit) and FDA Type C guidance are pivotal de-risking events, strengthening the case for targeted Phase 1b/2 trials across high‑value indications .
  • EPS beat (-$0.39 vs -$0.47) amid reduced operating expenses suggests disciplined cost control, but no revenue and ongoing net losses keep financing risk front-and-center .
  • Near-term catalysts (Nov 20 KOL webinar; Dec LP‑300 data; “Zeta” rollout) can drive sentiment and narrative momentum; monitor any partnering updates or AI module licensing traction .
  • Timelines have slipped into early 2026 for key trials; execution and funding are critical — ATM activity (~$1.62M gross since Q3) underscores need to balance dilution vs clinical progress .
  • Cash/securities of $12.4M and runway into ~Q3 2026 provide time for value-creating milestones, but explicit funding need commentary warrants attention to capital markets windows .
  • AI platform commercialization (predictBBB, LBx‑AI, Zeta) offers non-dilutive revenue optionality and differentiated competitive positioning; sustained validation and partnerships will be key .
  • Trading setup: Stock likely sensitive to clinical data flow and financing headlines; positive LP‑300 follow-up/LP‑184 KOL insights could be near-term upside catalysts, while delays or financing overhang may pressure shares.