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Stoke Therapeutics, Inc. (STOK)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024: Collaboration revenue was $4.22M, up QoQ from $2.80M but down YoY from $5.15M; net loss was $26.37M (EPS $(0.57)) vs $26.96M (EPS $(0.60)) in Q4 2023 and $22.55M (EPS $(0.53)) in Q1 2023 .
  • Clinical update remained the key driver: management emphasized “substantial and durable reductions in seizure frequency” and “clinically meaningful improvements” in cognition/behavior with STK-001; regulatory meetings on a randomized, controlled registrational study are planned with an update anticipated in 2H 2024 — a potential catalyst for the stock .
  • Balance sheet: $178.6M cash & cash equivalents at 3/31/24; a follow-on offering on April 2 added $120.3M net proceeds, materially strengthening liquidity heading into pivotal preparation activities .
  • No formal financial guidance was provided; prior commentary (as of 12/31/23) indicated cash runway into end of 2025, and the April raise likely extends flexibility for STK-001 Phase 3 prep and STK-002 Phase 1 (UK) initiation in 2024 .

What Went Well and What Went Wrong

What Went Well

  • Clinical momentum for STK-001: “substantial and durable reductions in seizure frequency and clinically meaningful improvements across multiple measures of cognition and behavior” supporting disease-modifying potential; plans to meet regulators for registrational study design in 2H 2024 .
  • Liquidity bolstered: post-quarter $120.3M net proceeds from an underwritten offering, improving funding ahead of pivotal prep and OSPREY initiation .
  • Organizational buildout for commercialization and finance: appointments of Chief Commercial Officer and CFO, reinforcing execution capabilities .

What Went Wrong

  • YoY top-line contraction: revenue recognized from the Acadia collaboration declined to $4.22M from $5.15M YoY, reflecting lower recognized services/upfront amortization timing .
  • Higher operating spend: R&D rose to $22.37M (from $19.63M YoY) as programs advanced; OpEx totaled $32.59M vs $29.84M YoY, widening net loss YoY to $26.37M (from $22.55M) .
  • No updated financial guidance provided; investors must rely on program milestones and prior runway commentary (end of 2025) alongside the April equity raise to frame funding visibility .

Financial Results

MetricQ3 2023Q4 2023Q1 2024
Revenue ($USD Millions)$3.31 $2.80 $4.22
Net Loss ($USD Millions)$(24.54) $(26.96) $(26.37)
EPS (Basic & Diluted, $)$(0.55) $(0.60) $(0.57)
R&D Expense ($USD Millions)$20.27 $21.78 $22.37
G&A Expense ($USD Millions)$10.27 $10.61 $10.22
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$214.7 $201.4 $178.6 (cash & equivalents)

Notes:

  • Q1 2024 cash & equivalents were $178.6M; marketable securities were $0 at 3/31/24 per balance sheet, vs $9.95M at 12/31/23 .
  • Revenue represents recognition of upfront license fees and services under the Acadia collaboration .

Segment breakdown: Stoke reports collaboration revenue; no operating segments disclosed .

Key KPIs

KPIQ3 2023Q4 2023Q1 2024
Deferred Revenue – Total ($USD Millions)$49.47 (8.74 current + 40.73 LT) $48.38 (15.31 current + 33.07 LT) $45.96 (20.92 current + 25.04 LT)
Weighted Avg. Shares (Basic & Diluted)44.27M 44.96M 46.25M
Post-Quarter Net Proceeds ($USD Millions)——$120.3 (April 2 offering)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCompany-level“Fund operations to the end of 2025” (as of 12/31/23) No update provided in Q1 release; added $120.3M net proceeds on Apr 2 Maintained runway commentary; liquidity strengthened
STK-001 Registration Path2024Phase 3 planning update expected 1H 2024 (Q3’23 commentary) Plan to meet regulators; update anticipated in 2H 2024 Timing updated to 2H 2024 update
STK-002 (OSPREY) Start2024Initiate Phase 1 in UK in 2024 Reiterated 2024 initiation Maintained
Financial Guidance (Revenue/OpEx)2024None providedNone providedN/A

Earnings Call Themes & Trends

Note: An earnings call transcript for Q1 2024 was not available in our corpus; themes are based on company press releases.

TopicPrevious Mentions (Q3 2023)Previous Mentions (Q4 2023)Current Period (Q1 2024)Trend
STK-001 efficacy/safetySustained seizure reductions; cognition/behavior improvements; PK exposure-response presented; planning for Phase 3 Year-end focus on liquidity; reiteration of program progress in narrative “Substantial and durable” seizure reductions; meaningful cognition/behavior gains; well tolerated up to 70mg; registrational study design meetings planned; 2H24 update Improving clarity; nearing pivotal path
Regulatory path (STK-001)Phase 3 design discussions targeted post Q1’24 readout —Regulator meetings planned; study design with 70mg initial dosing, continued dosing at 45mg; update 2H24 Advancing
STK-002 (ADOA)Phase 1 (OSPREY) to begin early 2024 (UK) Reiterated 2024 plan 2024 initiation reiterated; FALCON natural history data presented at ARVO On track
Collaboration (Acadia)Ongoing across Rett, SYNGAP1, undisclosed target —Ongoing collaboration reiterated Stable
Liquidity/runway$214.7M at 9/30/23; runway to end of 2025 $201.4M at 12/31/23; runway to end of 2025 $178.6M at 3/31/24; +$120.3M net proceeds on Apr 2 Strengthened post-quarter

Management Commentary

  • “Our recent data that showed substantial and durable reductions in seizure frequency and clinically meaningful improvements across multiple measures of cognition and behavior… support our belief that we are addressing the root cause of Dravet syndrome. We are working with a sense of urgency to meet with regulatory agencies to discuss our plans for a randomized, controlled registrational study for STK-001 and look forward to providing an update in the second half of 2024.” — Edward M. Kaye, M.D., CEO .
  • On financial position: “As of March 31, 2024, Company had $178.6 million in cash and cash equivalents… In April, Company strengthened its cash position with $120.3 million in net proceeds from public follow-on offering.” .

Q&A Highlights

  • Not available: We did not find a Q1 2024 earnings call transcript in our corpus; therefore, specific Q&A themes and management clarifications are unavailable.

Estimates Context

  • S&P Global consensus for Q1 2024 EPS and revenue was not retrievable due to S&P Global daily request limits; we therefore cannot provide vs-consensus comparisons for the quarter. Where consensus is essential for your workflow, we recommend cross-checking your S&P Global access or broker models.
  • Directionally, Stoke’s revenue reflects collaboration recognition timing rather than product sales; estimate revisions will likely hinge on regulatory feedback timing (2H 2024 update) and external clinical data presentations (EILAT/ASGCT) rather than near-term financial metrics .

Key Takeaways for Investors

  • Pivotal path clarity is the near-term stock driver: regulator meetings and a 2H 2024 update on the registrational trial design for STK-001 are high-impact catalysts .
  • Clinical profile strengthening: durable seizure reductions plus cognition/behavior gains differentiate STK-001 beyond seizure control, supporting a potential disease-modifying label narrative if confirmed in a randomized study .
  • Balance sheet improved post-quarter: $178.6M cash at Q1-end and $120.3M net proceeds in April provide runway flexibility for STK-001 Phase 3 prep and STK-002 Phase 1 initiation in 2024 .
  • Revenue/earnings remain non-core to the thesis near term; collaboration revenue recognition remains lumpy; focus should remain on clinical/regulatory milestones .
  • Watch deferred revenue trends as a signal of collaboration execution and services progress (total deferred revenue moved modestly lower sequentially as performance obligations are recognized) .
  • Organizational readiness: addition of a CCO and new CFO suggests Stoke is preparing for late-stage execution and eventual commercialization activities .

Additional Detail: Financial Statements and Items from Q1 2024 Press Release

  • Q1 2024 revenue: $4.216M (Acadia collaboration); R&D $22.368M; G&A $10.220M; net loss $(26.374)M; EPS $(0.57) .
  • Balance sheet at 3/31/24: cash & equivalents $178.581M; total current assets $193.275M; deferred revenue current $20.918M, long-term $25.042M .
  • Post-quarter offering (closed April 2, 2024): $120.3M net proceeds .

Supporting Prior-Quarter Comparisons

  • Q4 2023 revenue $2.801M; net loss $(26.958)M; EPS $(0.60); cash, cash equivalents & marketable securities $201.4M (runway to end of 2025) .
  • Q3 2023 revenue $3.308M; net loss $(24.542)M; EPS $(0.55); cash, cash equivalents & marketable securities $214.7M .

Other Relevant Q1 2024-period Press Releases/Events

  • Presentations at EILAT XVII (May 5–8) and ASGCT (May 7–11) highlighting STK-001 data; ARVO presentation for ADOA natural history (FALCON) .

Citations:

  • Q1 2024 8-K and press release details: .
  • Q4 2023 8-K and press release details: .
  • Q3 2023 8-K and press release details: .
  • Offering documents: .