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IT

Inhibikase Therapeutics, Inc. (IKT)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 reported net loss of $13.68M and EPS of $0.15 loss, impacted by a one-time, non-cash $7.36M IPR&D charge from the CorHepta acquisition and higher SG&A; EPS missed the S&P Global consensus (-$0.095)* while revenue remained $0 consistent with expectations .
  • Liquidity remained strong: cash, cash equivalents and marketable securities were $93.18M as of March 31, 2025; management disclosed runway for at least 12 months .
  • PAH program execution advanced: study design refinements with KOLs and plan to initiate Phase 2b IKT-001 in H2 2025; CEO emphasized readiness with new leadership team .
  • Strategic focus sharpened: risvodetinib (Parkinson’s) development paused; out-licensed with up to $47.5M in milestones and tiered royalties, aligning resources to PAH .
  • Near-term stock catalysts: finalization of Phase 2b study design “in the ensuing weeks” and trial initiation in H2 2025; leadership additions (CEO, President/Head of R&D, CSO, CFO) underpin execution credibility .

What Went Well and What Went Wrong

What Went Well

  • Strengthened balance sheet and disclosed sufficient liquidity for at least the next 12 months to fund operations and PAH trial preparations .
  • Clear clinical path and timeline: “well placed to initiate our Phase 2b clinical study of IKT-001 in PAH in the second half of 2025,” and study design finalization underway with KOLs .
  • Leadership depth in PAH: appointments of Chris Cabell (President & Head of R&D) and John Adams (CSO) to spearhead IKT-001; CEO Mark Iwicki added operational expertise; CFO David McIntyre appointed to bolster capital markets and governance .
    • Quote: “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.” — CEO Mark Iwicki .

What Went Wrong

  • EPS miss vs Street was driven by non-cash IPR&D write-off ($7.36M) tied to CorHepta acquisition; R&D and SG&A ramped materially YoY as the company pivots to PAH .
  • No revenue and higher operating loss given trial build-out and organizational scaling; total costs and expenses rose to $14.60M from $4.78M YoY .
  • Parkinson’s program (risvodetinib) primary hierarchical efficacy measure did not improve; the program was paused, creating dependence on PAH program for value creation .

Financial Results

Income Statement and EPS vs prior periods

MetricQ1 2024Q3 2024Q1 2025
Revenue ($USD Millions)$0.00 $0.00 $0.00
Total Costs & Expenses ($USD Millions)$4.78 $5.83 $14.60
Net Loss ($USD Millions)$4.65 $5.78 $13.68
Interest Income ($USD Millions)$0.13 $0.05 $0.92
EPS (Basic & Diluted, $)$0.73 loss $0.65 loss $0.15 loss
Weighted Avg Shares6,340,697 8,882,570 89,537,171

Notes:

  • Q1 2025 R&D included a non-cash IPR&D write-off of $7.36M related to CorHepta .
  • Change in fair value of contingent consideration was a $1.165M credit in Q1 2025 .

Operating Expense Detail

MetricQ1 2024Q3 2024Q1 2025
Research & Development ($USD Millions)$2.75 $4.19 $10.51
Selling, General & Administrative ($USD Millions)$2.03 $1.64 $5.25
Change in Fair Value – Contingent Consideration ($USD Millions)N/AN/A$(1.16)

Liquidity

MetricSep 30, 2024Dec 31, 2024Mar 31, 2025
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$3.24 $97.54 $93.18

Estimates vs Actuals (Q1 2025)

MetricActual Q1 2025S&P Global Consensus Q1 2025
Revenue ($USD Millions)$0.00 $0.00*
EPS ($)$0.15 loss $0.095 loss*

Values marked with * were retrieved from S&P Global.

Segment and KPIs

ItemQ1 2024Q3 2024Q1 2025
Reportable SegmentsSingle segment (therapeutics development) Single segment Single segment
Total Costs & Expenses ($USD Millions)$4.78 $5.83 $14.60
PAH R&D ($USD Millions)N/AN/A$9.33
Parkinson’s R&D ($USD Millions)$2.34 N/A$0.14

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 2b IKT-001 (PAH) initiationH2 2025Advancing into late-stage program; Study May Proceed letter (Sep 2024) Initiate Phase 2b in H2 2025; study design finalization “in the ensuing weeks” Maintained timeline; clarified readiness
PAH study designQ2 2025Protocol development and KOL engagement Finalize study design in weeks Firmed near-term milestone
Risvodetinib (Parkinson’s)2025Topline 201 trial in Q4 2024 Program paused post-201; out-licensed with up to $47.5M milestones + tiered royalties Strategic pivot; monetization optionality
Liquidity/runway12+ monthsPost-Oct financing, strong cash Runway at least 12 months from issuance of 10-Q Maintained disclosure

No financial guidance provided for revenue, margins, OpEx, OI&E, or tax rate in Q1 2025 materials.

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available in the document set.

TopicPrevious Mentions (Q-2: Q3 2024)Previous Mentions (Q-1: Q4 2024/FY 2024)Current Period (Q1 2025)Trend
PAH program strategyStudy May Proceed letter; plan to advance IkT-001Pro; manufacturing/dosage form work Focus on advancing IkT-001 into late-stage; leadership additions Finalizing Phase 2b design; initiate H2 2025; belief in efficacy/tolerability profile Strengthening execution and timeline clarity
Leadership/capability buildNew board members; financing partners CEO appointment planned; add President/CSO CEO (Iwicki), President/Head R&D (Cabell), CSO (Adams), CFO (McIntyre) appointed Material upgrade in PAH-experienced leadership
Parkinson’s programFinal patient visit; topline expected Q4 2024 FY wrap; still pending 201 trial results; hierarchy top efficacy not met; program paused; out-license Deprioritized; monetization via license
Regulatory/legal/macro (tariffs/data)Not emphasizedFY 2024 10-K risk baselineElevated disclosure on China manufacturing, tariff risks, data transfer regs Heightened macro-operational risk awareness
Liquidity/capital strategyUp to $275M financing potential via warrants $110M gross proceeds closed Oct 2024 12+ months runway; warrants outstanding; capital to execute Phase 2b Stable liquidity; execution funded

Management Commentary

  • CEO on trial readiness: “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 .
  • Strategic conviction: “We continue to believe that systemic exposure of imatinib with IKT-001 can be well tolerated and provide strong efficacy to patients suffering from PAH.” — Mark Iwicki .
  • Leadership rationale: “Chris and John are outstanding scientific leaders with established track records in pulmonary arterial hypertension… [they] will… execute on the IkT-001 Phase 2 clinical trial in PAH.” — CEO commentary on appointments .
  • CFO appointment: “We look forward to leveraging [David’s] expertise as we continue to advance IkT-001 for PAH patients.” — CEO .
  • Program pivot: Parkinson’s 201 trial met safety/tolerability but did not improve the top hierarchical efficacy measure; program paused with strategic options (now out-licensed) .

Q&A Highlights

No public Q1 2025 earnings call transcript was available; guidance clarifications occurred via press releases and the 10-Q .

Estimates Context

  • EPS: Actual $0.15 loss vs S&P Global consensus $0.095 loss*; variance primarily due to non-cash IPR&D write-off ($7.36M) and higher SG&A tied to leadership build-out and severance .
  • Revenue: Actual $0 vs consensus $0*, consistent with pre-revenue biotech status and 10-Q disclosure of no revenue .

Values marked with * were retrieved from S&P Global.

Key Takeaways for Investors

  • EPS miss was driven by identifiable, largely non-recurring items (IPR&D write-off, severance, stock comp) rather than structural deterioration; expect EPS volatility through trial ramp .
  • Liquidity is sufficient for near-term execution; $93.18M cash/securities and disclosed 12+ months runway support Phase 2b start and early conduct .
  • Execution credibility improved with PAH-experienced leadership; CEO, President/Head of R&D, CSO, and CFO appointments are a positive for timelines and trial quality .
  • Near-term catalysts: Phase 2b design finalization (weeks) and H2 2025 initiation; monitor any Orphan Drug Designation progress and trial site activation cadence .
  • Strategic focus on PAH reduces pipeline complexity; out-licensing of risvodetinib creates milestone/royalty optionality without near-term cash burn .
  • Macro/manufacturing risks merit monitoring (China-related supply chain, tariff policy, sensitive data restrictions); could affect CMO timelines/costs .
  • Trading implications: stock likely sensitive to incremental PAH trial updates (protocol specifics, endpoints, enrollment start), regulatory interactions, and any warrant exercises affecting float/capital .