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Stoke Therapeutics, Inc. (STOK)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 delivered steady execution: revenue of $4.8M from the Acadia collaboration, net loss of $25.7M ($0.46 per share), and operating loss of $29.3M; liquidity remained strong with $282.0M in cash, cash equivalents, and marketable securities .
  • A key regulatory catalyst: the FDA removed the Partial Clinical Hold on zorevunersen (STK‑001), enabling progress toward a single, global Phase 3 registrational study; management expects a Phase 3 update in 2H 2024 .
  • R&D intensity remains elevated with Q2 R&D at $21.1M (vs. $22.4M in Q1), while G&A rose to $13.0M; year-to-date operating expenses increased on personnel, third-party contracts, and development activities for zorevunersen and STK‑002 .
  • Prior quarters contextualize the trajectory: Q1 2024 revenue was $4.2M with net loss of $26.4M ($0.57/share), and Q4 2023 revenue was $2.8M with net loss of $27.0M ($0.60/share); cash was $193.5M (Q4) and $178.6M (Q1) .
  • Stock reaction catalyst: removal of the Partial Clinical Hold and the path toward Phase 3 for zorevunersen, plus STK‑002 Phase 1 (OSPREY) initiation plans in 2024 .

What Went Well and What Went Wrong

What Went Well

  • FDA removed the Partial Clinical Hold for zorevunersen, clearing a regulatory path toward Phase 3; management aims for agreement on a single, global registrational design by year-end .
  • CEO highlighted “landmark data” with marked seizure reductions and cognition/behavior improvements in Dravet patients; strong community urgency supports development .
  • Liquidity solid at $282.0M; sequential cash and marketable securities increased, supporting ongoing clinical execution and corporate growth .

What Went Wrong

  • Operating expenses stepped up: G&A rose to $13.0M in Q2 (from $10.2M a year ago), reflecting scaling costs of a growing public company and program advancement .
  • Continued net losses: Q2 net loss of $25.7M persisted as programs advance (vs. $30.7M in Q2 2023), highlighting the pre-commercial burn profile .
  • Organizational change: COO step-down (remaining Chief Business Officer) could raise questions about operational continuity amid near-term regulatory milestones .

Financial Results

Consolidated Financials vs Prior Periods

MetricQ4 2023Q1 2024Q2 2024
Revenue ($USD Millions)$2.801 $4.216 $4.831
Net Loss ($USD Millions)$26.958 $26.374 $25.695
Net Loss per Share ($USD)$0.60 $0.57 $0.46
Loss from Operations ($USD Millions)$29.587 $28.372 $29.342
R&D Expense ($USD Millions)$21.778 $22.368 $21.136
G&A Expense ($USD Millions)$10.610 $10.220 $13.037
Cash and Equivalents ($USD Millions)$191.442 $178.581 $193.476
Marketable Securities ($USD Millions)$9.952 $0.000 $88.506
Total Cash, Equivalents, and Marketable Securities ($USD Millions)$201.394 $178.581 $282.0

Actuals vs Consensus (Q2 2024)

MetricActualConsensus (S&P Global)Surprise
Revenue ($USD Millions)$4.831 N/A (S&P Global consensus unavailable)N/A
EPS ($USD)$(0.46) N/A (S&P Global consensus unavailable)N/A
Disclaimer: Wall Street consensus values unavailable due to S&P Global data access limits.

Revenue Composition (Q2 2024)

SourceQ2 2024
License & Collaboration (Acadia) ($USD Millions)$4.831

KPIs

KPIQ4 2023Q1 2024Q2 2024
Deferred Revenue – Current ($USD Millions)$15.309 $20.918 $26.051
Deferred Revenue – Non-Current ($USD Millions)$33.074 $25.042 $16.946
Weighted-Average Shares (Basic & Diluted)44,958,894 46,246,889 55,765,948

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayAs of 12/31/2023Anticipated to fund operations to end of 2025 No update provided in Q2 release N/A
Zorevunersen Phase 3 plan2024Update anticipated in 2H 2024 On track to provide regulatory update in 2H 2024 Maintained
STK‑002 Phase 1 (OSPREY) initiation2024Initiation planned in 2024 On track to initiate in 2024 Maintained

Earnings Call Themes & Trends

Note: A Q2 2024 earnings call transcript was not available in our document catalog or internet sources reviewed; themes are derived from press releases and 8‑Ks.

TopicPrevious Mentions (Q4 2023, Q1 2024)Current Period (Q2 2024)Trend
Regulatory/legalCash runway to end of 2025; ongoing development of STK‑001/STK‑002 FDA removed Partial Clinical Hold; aiming for single, global Phase 3 design by year-end Positive regulatory momentum
R&D executionPresented new STK‑001 data and Phase 3 planning timing; STK‑002 Phase 1 planned Zorevunersen data shared/planned at EEC; STK‑002 Phase 1 on track Consistent execution
CollaborationsAcadia collaboration ongoing (Rett, SYNGAP1, undisclosed) Revenue recognized from Acadia collab in Q2 Steady contribution
Product performanceSubstantial seizure reduction and cognitive/behavior improvements in STK‑001 studies Management reiterates “landmark data” supporting disease modification Reinforced efficacy narrative
Corporate/managementStable team; subsequent Q2 change in COO role COO stepped down (continues as CBO) Organizational transition
Liquidity$201.4M at 12/31/23; runway to end 2025 $282.0M liquidity at 6/30/24 Strengthened liquidity

Management Commentary

  • “The landmark data announced earlier this year provide strong support for zorevunersen as the first potential disease-modifying medicine for the treatment of Dravet syndrome by showing marked reductions in seizures and improvements in cognition and behavior…” — Edward M. Kaye, M.D., CEO .
  • “We thank the FDA for working with us to remove the Partial Clinical Hold and look forward to…agreeing on a single, global Phase 3 registrational study design by year-end.” — Edward M. Kaye, M.D. .
  • “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. (Q1 release) .

Q&A Highlights

  • No Q2 2024 earnings call transcript was available in our sources; therefore, Q&A themes could not be extracted. Our review covered SEC filings and company press releases; no transcript was found in the catalog between July–September 2024 [ListDocuments result showing 0 transcripts] and via supplementary search .

Estimates Context

  • S&P Global consensus estimates for Q2 2024 were unavailable due to access limits; as a result, we cannot quantify beats/misses vs Wall Street consensus. Actuals for Q2 were revenue $4.831M and EPS $(0.46) . Disclaimer: Wall Street consensus values unavailable due to S&P Global data access limits.

Key Takeaways for Investors

  • Regulatory overhang lifted: FDA removal of the Partial Clinical Hold is a material de-risking event and positions zorevunersen for a global Phase 3 design decision in 2H 2024, a likely stock narrative driver .
  • Liquidity strong: $282.0M in cash/equivalents/marketable securities supports clinical execution and corporate scaling while pre-commercial losses persist .
  • Operating discipline: R&D held near prior-quarter levels ($21.1M vs. $22.4M in Q1), while G&A increased with corporate growth; monitor OpEx trajectory into Phase 3 preparations .
  • Collaboration revenue steady: Q2 revenue of $4.8M from Acadia reflects ongoing partnership execution, an important non-dilutive funding source .
  • Watch near-term catalysts: Phase 3 design alignment by year-end and EEC data presentations may shape sentiment on disease-modifying potential and regulatory timelines .
  • Organizational change: COO role transition warrants attention for operational continuity through pivotal planning and trial initiation .
  • Trading lens: Expect headline sensitivity to further regulatory updates and any guidance on Phase 3 timing/enrollment; with consensus unavailable, price action likely anchors to qualitative milestones rather than numeric beats/misses .