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Relay Therapeutics, Inc. (RLAY)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 was defined by clinical momentum (positive interim RLY-2608 data) and a strengthened balance sheet; financials featured $0 revenue, net loss of $88.1M and EPS of $(0.63) as the company invests ahead of pivotal execution .
  • Management highlighted 9.2-month median PFS and a 33% ORR (53% for kinase mutations) for RLY-2608 + fulvestrant at RP2D, and plans to initiate a 2L pivotal trial in 2025, framing this as a key value-creation catalyst .
  • Cash, cash equivalents and investments reached $839.6M, with runway guided into 2H 2027; the uplift reflected a $230M September follow-on and a $50M annual savings plan (15% workforce reduction) to tilt toward late-stage development .
  • Estimate benchmarking was not available due to S&P Global rate limits; however, the core stock catalysts near term are SABCS disclosure in December and 2025 pivotal trial initiation for RLY-2608, alongside partnering steps for lirafugratinib (subsequently licensed to Elevar on Dec 3) .

What Went Well and What Went Wrong

  • What Went Well

    • Clinically meaningful RLY-2608 doublet efficacy at RP2D: median PFS 9.2 months across all mutations (10.3 months in kinase mutations) and 33% ORR (53% kinase), with favorable tolerability (only one Grade 3 hyperglycemia at RP2D) .
    • Strategic clarity and financing: plan to initiate a 2L pivotal trial in 2025 and cash runway extended into 2H 2027; CEO emphasized ability to fully fund through top-line with existing cash .
    • Portfolio focus and cost discipline: $50M annualized savings and ~15% workforce reduction to support development focus; triplet regimens advancing (ribociclib dose expansion expected 1H 2025; atirmociclib trial initiation by YE 2024) .
    • Quote: “Based on these data, we are preparing to initiate a pivotal trial in 2L breast cancer in 2025, which we expect to be able to fully fund through top-line readout with our existing cash on hand.” – CEO Sanjiv Patel .
  • What Went Wrong

    • No revenue in Q3 vs $25.2M in Q3’23, reflecting the absence of collaboration milestone recognition that boosted the prior-year period .
    • Net loss widened YoY to $88.1M (from $65.7M) and EPS to $(0.63) (from $(0.54)), driven by the lack of revenue and continued R&D investment despite some prioritization .
    • Lirafugratinib regulatory path requires staged filings (first CCA NDA, then tumor-agnostic sNDA) and the company sought a commercialization partner to maintain portfolio focus (partnership subsequently announced post-quarter) .

Financial Results

  • Income statement and cash metrics
Metric (USD)Q1 2024Q2 2024Q3 2024
Revenue ($ Millions)$10.007 $0.119 $0.000
R&D Expense ($ Millions)$82.403 $91.992 $76.619
G&A Expense ($ Millions)$19.799 $20.139 $19.750
Net Loss ($ Millions)$(81.387) $(92.212) $(88.105)
Diluted EPS ($)$(0.62) $(0.69) $(0.63)
Cash, Cash Equivalents & Investments ($ Millions)$749.608 $688.415 $839.609
  • Year-over-year comparison (Q3 only)
Metric (USD)Q3 2023Q3 2024YoY Commentary
Revenue ($ Millions)$25.202 $0.000 Q3’23 benefitted from Genentech milestone recognition; no revenue in Q3’24 .
Net Loss ($ Millions)$(65.734) $(88.105) Wider net loss driven by lack of revenue and continued investment .
Diluted EPS ($)$(0.54) $(0.63) EPS loss widened YoY .
  • KPIs and operating context
KPIQ1 2024Q2 2024Q3 2024
Cash Runway (Mgmt)Into 2H 2026 Into 2H 2026 Into 2H 2027
Capital Raise$230M follow-on (Sept 2024)
Cost Actions~$50M annual savings; ~15% workforce reduction

Notes: Relay reports no product revenue; revenue variability reflects collaboration and milestone timing, not commercial activity .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-yearInto 2H 2026 (as of Q2) Into 2H 2027 (as of Q3) Raised
RLY-2608 + Fulvestrant (2L) Pivotal2025Potential Phase 3 initiation in 2025 2L Phase 3 initiation in 2025 confirmed Maintained/clarified
RLY-2608 + Ribociclib + Fulvestrant1H 2025Initial safety data in Q4’24; dose expansion 1H’25 Initial safety Q4’24; dose expansion 1H’25 Maintained
RLY-2608 + Atirmociclib (CDK4) + FulvestrantYE 2024Initiation by YE 2024 On track to initiate by YE 2024 Maintained
Lirafugratinib Regulatory Path2H 2024 updateData + regulatory update in 2H’24 FDA suggested first file CCA NDA; plan to seek commercialization partner Updated
Operating ModelOngoing~$50M annual savings; ~15% workforce reduction New
Financing2024$230M gross proceeds follow-on (Sept) New

Earnings Call Themes & Trends

Note: A Q3’24 earnings call transcript was not available in our document set; themes reflect company disclosures in Q1/Q2/Q3 communications.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2024)Trend
RLY-2608 doublet efficacy/tolerabilityQ1: data update planned 2H’24; Q2: update in Q4’24; enrollment at 400/600mg BID Interim at RP2D: PFS 9.2m (10.3m kinase), ORR 33% (53% kinase), favorable AE profile Strengthening clinical profile
Triplet regimens (ribociclib, atirmociclib)Q1/Q2: ribociclib triplet enrolling; atirmociclib collab announced; start by YE’24 Ribo dose escalation testing biologically active doses; dose expansion 1H’25; atirmociclib on track YE’24 start On plan/progressing
Lirafugratinib (RLY-4008) regulatoryQ1: minimized 2024 spend; Q2: tumor-agnostic data + regulatory update in 2H’24 FDA suggested CCA-first NDA; company to seek global commercialization partner Regulatory clarity; partner strategy
Cash runway/financingQ1: $749.6M; runway into 2H’26 ; Q2: $688.4M; 2H’26 $839.6M; runway into 2H’27; $230M follow-on; $50M savings Improved runway
Pipeline expansion (vascular malformations, Fabry, NRAS)Q2: disclosed new programs and 2025 clinic starts Timelines reiterated: vascular malformations Q1’25; Fabry/NRAS 2H’25 On track

Management Commentary

  • Strategic focus: “Based on these data, we are preparing to initiate a pivotal trial in 2L breast cancer in 2025, which we expect to be able to fully fund through top-line readout with our existing cash on hand.” – Sanjiv Patel, M.D., President & CEO .
  • Portfolio prioritization: Company will seek a global commercialization partner for lirafugratinib to maintain focus on remainder of the portfolio; FDA suggested staged filings (CCA then tumor-agnostic) .
  • Operating model shift: Streamlined research organization to support upcoming pivotal study and 2025 clinic entries; ~$50M annual savings and ~15% workforce reduction .

Q&A Highlights

  • A Q3 2024 earnings call transcript was not available in our document corpus; therefore, no Q&A details were reviewable. The themes and clarifications above are drawn from the press release and 8-K disclosures .

Estimates Context

  • We attempted to retrieve S&P Global consensus for revenue and EPS for Q3 2024 and the prior two quarters, but could not due to rate limits. As a result, we cannot quantify beats/misses versus Street for this quarter (will update upon retrieval) [GetEstimates errors].
  • Management did not issue formal revenue/expense guidance; the key quantitative anchor for forward modeling is cash runway into 2H 2027 and the 2025 pivotal start for RLY-2608 .

Key Takeaways for Investors

  • 2025 RLY-2608 pivotal start is the main catalyst; interim data (PFS/ORR and tolerability) de-risk the clinical thesis and support the 2L study design, with additional visibility at SABCS in December .
  • Balance sheet sufficiently capitalized (cash ~$840M; runway into 2H 2027) post $230M follow-on and $50M annualized savings; management asserts ability to fund pivotal through top-line readout .
  • Triplet regimens aim to expand the opportunity (front-line setting) with ribociclib dose expansion planned for 1H 2025 and atirmociclib program initiating YE 2024—watch for safety/combination tolerability updates .
  • Lirafugratinib strategy pivoted to partner-led path after FDA suggested a CCA-first NDA; subsequent Elevar deal (Dec 3) should reduce Relay’s capital burden and sharpen focus on PI3Kα programs .
  • Financial optics YoY are noisy due to collaboration revenue timing; Q3’24 had $0 revenue vs $25.2M in Q3’23; investors should focus on operating discipline and pipeline milestones rather than near-term P&L variability .
  • Near-term trading setup: December SABCS data visibility and any pipeline/regulatory disclosures could drive sentiment; medium-term thesis rests on executing the RLY-2608 pivotal and demonstrating durable, tolerable combination regimens .

Citations: 8-K and Exhibit 99.1 PR for Q3 2024 ; Q3 2024 press release and financial tables ; Q2 2024 press release and tables ; Q1 2024 8-K and tables ; September 9, 2024 RLY-2608 data PR ; November 7, 2024 events PR ; December 3, 2024 Elevar deal PR .