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IT

Inhibikase Therapeutics, Inc. (IKT)·Q2 2025 Earnings Summary

Executive Summary

  • Inhibikase reported a Q2 2025 net loss of $9.9M, or $0.11 per share, with cash, cash equivalents and marketable securities of $87.7M; R&D was $5.3M and SG&A was $5.9M .
  • EPS missed Wall Street consensus by $0.03 (actual -$0.11 vs -$0.08 consensus); revenue was in line with a $0.00 estimate as the company remains pre-revenue *.
  • Management finalized the Phase 2b IMPROVE-PAH protocol for IKT-001 and expects initiation in H2 2025, maintaining the timeline communicated in Q1 2025 .
  • Strategic build-out continued with the appointment of a Chief Commercial and Strategy Officer (Aug 19), bolstering commercial planning ahead of late-stage development in PAH .

What Went Well and What Went Wrong

What Went Well

  • Finalized Phase 2b protocol and reiterated H2 2025 start: “We have now finalized our study protocol, and we expect to initiate our Phase 2b clinical study of IKT-001…in the second half of 2025.” — Mark Iwicki, CEO .
  • Clinical rationale reinforced: Management highlighted IMPRES and recent AJRCCM data supporting imatinib efficacy at higher exposures, aligning IKT-001’s prodrug design to improve GI tolerability at efficacious doses .
  • Leadership build-out: Appointment of a seasoned PAH commercial executive (Timothy Pigot) strengthens go-to-market thinking and KOL engagement ahead of late-stage trials .

What Went Wrong

  • EPS miss vs consensus: Actual Q2 EPS of -$0.11 missed the -$0.08 consensus, as higher SG&A ($5.9M) and ongoing R&D spending weighed on results *.
  • Elevated operating expenses: SG&A rose YoY to $5.9M and included $1.0M severance; six‑month R&D of $15.8M included a $7.4M non‑cash IPR&D write‑off from the CorHepta acquisition .
  • Share dilution optics: Weighted-average shares jumped to 90.0M in Q2 2025 vs 7.5M in Q2 2024, reflecting prior financings and share issuances, which can pressure per-share metrics .

Financial Results

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD)$0 $0 $0
Net Loss ($USD)$(4.96)M $(13.68)M $(9.92)M
Diluted EPS ($USD)$(0.66) $(0.15) $(0.11)
R&D Expense ($USD)$3.08M $10.51M $5.27M
SG&A Expense ($USD)$1.97M $5.25M $5.92M
Loss from Operations ($USD)$(5.05)M $(14.60)M $(10.83)M
Interest Income ($USD)$0.09M $0.92M $0.92M
Cash & Equivalents (end-period) ($USD)$3.09M $73.44M $77.74M
Marketable Securities (end-period) ($USD)$4.85M $19.74M $9.92M
Cash + Marketable Securities (end-period) ($USD)$7.94M $93.18M $87.67M
Weighted Avg Shares (Basic & Diluted)7.54M 89.54M 90.01M
Actual vs ConsensusQ1 2025Q2 2025
Revenue Actual ($USD)$0 $0
Revenue Consensus ($USD)$0.00*$0.00*
EPS Actual ($USD)$(0.15) $(0.11)
EPS Consensus ($USD)$(0.095)*$(0.08)*

Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 2b IMPROVE-PAH initiation (IKT-001)H2 2025“Expect to initiate Phase 2b in H2 2025; study design to be finalized in ensuing weeks.” (Q1 2025) “Protocol finalized; expect to initiate Phase 2b in H2 2025.” (Q2 2025) Maintained timeline; progressed protocol to finalized

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024 and Q1 2025)Current Period (Q2 2025)Trend
Clinical timeline (IKT-001 in PAH)Study May Proceed received (Sep 2024); gearing toward Phase 2b; leadership hires to accelerate execution . Q1: refining study design with KOLs; expect finalization and H2 2025 initiation .Protocol finalized; H2 2025 initiation reiterated .Execution advancing; timeline maintained
R&D strategy and tolerabilityBridged imatinib from oncology to PAH; dossier supports efficacy; manufacturing scale-up for tablets .Emphasized high-exposure efficacy (IMPRES/AJRCCM); IKT-001 designed to minimize GI side effects .Scientific narrative strengthened
Financing and cash runwayOct 2024 private placement ~$110M; potential up to $275M with warrants; YE24 cash & securities $97.5M .Q2 2025 cash & securities $87.7M .Healthy balance; deploying into R&D
Leadership and commercializationExpanded Board with biotech veterans .Added Chief Commercial & Strategy Officer with PAH market experience .Commercial readiness improving
OpEx and one-time items2024 R&D $17.2M; SG&A $11.4M .Q2 SG&A includes $1.0M severance; YTD R&D includes $7.4M non-cash IPR&D write-off (CorHepta) .OpEx elevated; identifiable drivers

Management Commentary

  • “We have now finalized our study protocol, and we expect to initiate our Phase 2b clinical study of IKT-001…in PAH in the second half of 2025.” — Mark Iwicki, CEO .
  • “With our core team now in place…IKT is well placed to initiate our Phase 2b clinical study of IKT-001 in PAH in the second half of 2025.” — Mark Iwicki (Q1 2025) .
  • R&D/SG&A context: six-month 2025 R&D included a $7.4M non-cash IPR&D write-off tied to CorHepta; SG&A included $1.0M severance due to senior executive transitions .

Q&A Highlights

  • No Q2 2025 earnings call transcript was available; the company furnished its results via 8‑K and press release on Aug 14, 2025 .

Estimates Context

  • Q2 2025: EPS of -$0.11 missed consensus of -$0.08; revenue was in line with a $0.00 estimate as the company is pre-revenue *.
  • Q1 2025: EPS of -$0.15 missed consensus of -$0.095; revenue was in line with a $0.00 estimate *.
  • Model implications: Street may incorporate higher SG&A (including severance) and R&D cadence (including the non-cash IPR&D write-off) into H2 assumptions, with funding sufficient to support Phase 2b initiation in H2 2025 .
    Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalyst: Phase 2b IMPROVE-PAH initiation in H2 2025; protocol finalized, suggesting operational readiness and potential for investor event flow around site activation and first patient in .
  • Scientific rationale is robust: IMPRES and contemporary data support imatinib efficacy at higher exposures; IKT-001’s prodrug design targets GI tolerability at efficacious doses, aiming to unlock best-in-class outcomes .
  • Balance sheet supports execution: $87.7M in cash and marketable securities at Q2 end, following the Oct 2024 financing; provides runway for Phase 2b conduct .
  • Watch OpEx trajectory: SG&A step-up (severance) and R&D one-time IPR&D write-off skewed YTD costs; monitor normalized quarterly OpEx as trial initiates .
  • EPS may remain volatile near-term: Pre-revenue biotech with scaling organization; EPS misses vs consensus reflect investment ahead of clinical milestones; Street models likely to recalibrate OpEx assumptions * .
  • Strategic hiring signals commercial intent: Addition of Chief Commercial & Strategy Officer adds market expertise as the program advances, a positive indicator for eventual launch planning .
  • Trading implications: Stock likely to be event-driven around Phase 2b start, interim safety analysis, and any early operational updates; sentiment hinges on execution against H2 2025 timeline .

Bolded beats/misses:

  • EPS missed consensus in Q2 2025 (-$0.11 vs -$0.08) *.

Notes: Values marked with * retrieved from S&P Global.