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IT

Inhibikase Therapeutics, Inc. (IKT)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 headline was capital and focus: YE24 liquidity jumped to $97.5M in cash, cash equivalents and marketable securities following October’s ~$110M private placement; management sharpened strategy to advance IkT-001 toward a late-stage PAH program and added seasoned PAH leadership .
  • Financially, IKT reported no revenue for FY24 and a full-year net loss of $27.5M ($1.16 per share); FY R&D rose to $17.2M and SG&A to $11.4M as the company prepared for late-stage development and rebuilt the team .
  • Versus S&P Global consensus, Q4 EPS was below expectations (actual: -$0.17 vs. -$0.09 estimate; revenue in line at $0)*, driven by higher operating spend as the company pivoted to PAH and leadership expansion (see Financial Results) .
  • Stock reaction catalysts ahead: PAH Phase 2b “702” setup and site activation, planned safety and futility gates, and organizational execution under the new CEO and R&D leaders .

What Went Well and What Went Wrong

What Went Well

  • Strategic capital raise and board refresh: “Closed a private placement with gross proceeds of approximately $110 million in October 2024 … aggregate total gross proceeds … up to $275 million” and added high-profile directors including an independent Chair .
  • Clinical focus and leadership depth for PAH: “Focus on advancement of IkT-001 into a late-stage clinical trial program in PAH… added depth to our management team with the additions of Chris Cabell … and John Adams” (CEO Mark Iwicki) .
  • Regulatory momentum: FDA “Study May Proceed” letter (Sept-2024) clears the path to enter Phase 2b in PAH; prior FDA interactions affirmed NME treatment path for IkT-001/001Pro .

What Went Wrong

  • Earnings below consensus in Q4: EPS missed S&P Global consensus as operating costs stepped up with program acceleration and corporate build-out (see Financial Results)* .
  • No revenue base; net losses widened YoY: FY24 revenue was $0 (vs. $0.26M in FY23), with net loss increasing to $27.5M as R&D and SG&A grew to progress late-stage readiness .
  • Pre-financing balance sheet tightness: Cash + marketable securities were $3.2M at 9/30/24 (pre-October raise), underscoring financing dependence and execution risk in small-cap biotech .

Financial Results

Quarterly progression (trend analysis)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$0.00 $0.00 $0.00*
Net Income (Loss) ($USD Millions)$(4.96)*$(5.78) $(12.13)*
Diluted EPS ($)$(0.66) $(0.65) $(0.17)*
Total Operating Expenses ($USD Millions)$5.05 $5.83 $12.93*
Cash + Marketable Securities (period end) ($USD Millions)$7.90 $3.24 $97.54

Notes: Asterisked values are from S&P Global; values retrieved from S&P Global.*

Full-year comparison (YoY)

MetricFY 2023FY 2024
Revenue ($USD Millions)$0.26 $0.00
Total Operating Expenses ($USD Millions)$20.35 $28.59
Net Loss ($USD Millions)$(19.03) $(27.52)
Diluted EPS ($)$(3.16) $(1.16)
Cash and Cash Equivalents ($USD Millions)$9.17 $56.49
Cash + Marketable Securities ($USD Millions)$13.25 $97.54

Q4 2024 Actual vs. S&P Global Consensus

MetricActualConsensusSurprise
Revenue ($USD Millions)$0.00*$0.00*In line*
Diluted EPS ($)$(0.17)*$(0.09)*Miss $(0.08)*

Notes: Asterisked values are from S&P Global; values retrieved from S&P Global.*

Segment breakdown: Not applicable (no product revenue) .

KPIs (operational/financial):

  • YE24 Liquidity (Cash + Marketable Securities): $97.5M .
  • FY24 R&D: $17.21M; FY24 SG&A: $11.38M .
  • Q3 2024 net loss: $(5.78)M; EPS: $(0.65) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial guidance (revenue, EPS, OpEx)2025None issuedNone issuedMaintained (no formal guidance)
PAH Phase 2b “702” trial – initiation and design2025+Planning in 2024Proceeding toward late-stage; IND-cleared; ~100-patient Phase 2b, placebo-controlled; 12-week safety review; 24-week futility analysis (plan) Operational plan detailed
Organizational build2025N/ACEO transition (Mark Iwicki), appointment of President/Head of R&D (Chris Cabell) and CSO (John Adams) Strengthened leadership

No dividend or tax-rate guidance disclosed .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3 2024)Current Period (Q4 2024 context)Trend
PAH program (IkT-001/001Pro)Pre-IND alignment, NME status confirmed; IND filed Aug-2024; FDA “Study May Proceed” Sept-2024; design elements for Phase 2b and go-forward plan articulated Focused strategy to advance IkT-001 into late-stage PAH; building team to execute Phase 2b Accelerating execution
Financing/capital runwayQ2 liquidity $7.9M and runway into Dec-2024; financing need recognized ~$110M private placement closed Oct-2024; YE24 cash + M.S. $97.5M Strongly improved balance sheet
Leadership & governanceN/ANew CEO (Mark Iwicki) and senior R&D hires; board expansion with experienced operators/investors Organizational upgrade
Parkinson’s (risvodetinib)Phase 2 ‘201’ enrollment complete; topline targeted 4Q24; OLE planning; Phase 3 framework outlined Q4 press releases focused on PAH; 201 topline expectation was 4Q24 as of Q3 release Awaiting clarity on PD readout timing
CMC/ManufacturingScale-up for 001Pro dosage forms and throughput; differentiation vs. generic imatinib aligned with FDA feedback Continued positioning for late-stage supply as PAH becomes lead focus Advancing for late-stage needs
Regulatory/legalIND cleared for PAH (9/9/24); NME designation pathway discussed Operational focus to initiate Phase 2b and execute safety/futility gates Constructive FDA dialogue maintained

Management Commentary

  • “The financing concluded in October positioned us to focus our clinical development efforts on advancing IkT-001 toward a late-stage clinical trial in PAH… We enter 2025 well positioned to aggressively advance our IkT-001 development plan.” — CEO Mark Iwicki .
  • “The Company received its Study May Proceed letter for the Phase 2b trial in September 2024.” .
  • On financing significance: “This investment… recognized the potential of IkT-001Pro to improve the lives of patients afflicted with PAH.” — Dr. Milton Werner, President & CEO (Q3 PR) .

Q&A Highlights

  • OLE timing in PD ‘201’: Company prepared regulatory/IRB steps; financial constraints were gating, expecting formal launch in “couple of months,” tracking symptomatic med use in the interim .
  • Phase 3 PD design: Two global trials totaling ~300–400 patients over ~12 months dosing; designed to avoid confounding symptomatic therapies in untreated PD .
  • PAH Phase 2b design and gates: ~100 patients, two doses vs placebo; 12-week safety review at half-enrolled; futility analysis at 24 weeks; potential path to conditional approval if efficacy/safety align .
  • Start-up gating factors for PAH trial: 9–12 months to gear-up sites/infrastructure; capital and long-term extension commitments are important considerations .

Estimates Context

  • Q4 2024 results vs S&P Global consensus: EPS $(0.17) vs $(0.09) estimate (miss) and revenue $0.00 vs $0.00 (in line). Limited analyst coverage (3 EPS/Revenue estimates). Target price consensus averaged $8 (2 estimates)*.
  • With operating spend stepping up for PAH readiness and leadership build-out, near-term EPS estimates may drift lower absent revenue offset; however, strengthened liquidity reduces financing overhang risk.
    Notes: Asterisked values are from S&P Global; values retrieved from S&P Global.*

Key Takeaways for Investors

  • Balance sheet transformed: YE24 cash + marketable securities of $97.5M materially derisks near-term funding and supports PAH Phase 2b execution .
  • Strategic focus on PAH: Regulatory momentum (Study May Proceed) and clear Phase 2b design with planned safety/futility gates are the primary clinical catalysts .
  • Leadership upgrade: New CEO and experienced PAH R&D leadership should improve probability of trial execution and partnering optionality .
  • Financials: No revenue base; FY24 loss widened as R&D/SG&A rose to support late-stage plans; Q4 EPS below S&P consensus underscores spend cadence into 2025* .
  • PD optionality: Prior-period commentary suggested potential 201 topline in 4Q24 and Phase 3 framework; clarity on PD next steps remains a secondary catalyst after PAH .
  • Trading setup: Near-term stock moves likely tied to PAH trial start progress (site activations), any partnering updates, and early safety signals; balance-sheet strength may mitigate downside on timelines .

Sources and key documents:

  • Q4 2024 8-K and press release (Ex. 99.1): financial results and strategy/leadership updates .
  • Prior quarters (trend): Q3 2024 press release (financials and PAH status) ; Q2 2024 press release and call transcript .
  • Financing press releases (Oct-2024): pricing and closing details .

Note on Q4 2024 earnings call transcript: A Q4 call transcript was not available in the document set; we searched for an earnings-call-transcript in March–April 2025 and found none.

Asterisked values are from S&P Global; values retrieved from S&P Global.*