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LT

LENZ Therapeutics, Inc. (GRPH)·Q3 2022 Earnings Summary

Executive Summary

  • Pre-revenue clinical-stage quarter anchored by first-patient dosing of nula-cel in SCD and operational build-out; cash, cash equivalents and marketable securities were $305.1M with runway into Q4 2024 .
  • Operating expenses rose year over year with R&D at $18.30M and G&A at $7.85M; net loss improved modestly sequentially to $24.68M (EPS $(0.45)) from $25.94M in Q2 (EPS $(0.48)) .
  • Strategic manufacturing partnership signed with WuXi Advanced Therapies to support nula-cel scale-up toward later-stage trials; two abstracts accepted for ASH in December, including scRNAseq method to assess gene correction outcomes and a beta-thalassemia (GPH102) platform update .
  • Initial nula-cel proof-of-concept (PoC) data remains on track for mid-2023—a key stock catalyst given the first-in-class gene correction approach in SCD; enrollment in the Phase 1/2 CEDAR trial is ongoing at multiple U.S. sites .

What Went Well and What Went Wrong

  • What Went Well

    • First patient dosed with nula-cel in CEDAR; CEO emphasized it “mark[s] the first time an investigational therapy designed to correct a genetic mutation has been administered to a patient,” with initial PoC data targeted mid-2023 .
    • Manufacturing readiness de-risked via WuXi Advanced Therapies partnership to support development scale-up and potential commercialization preparation .
    • Scientific presence strengthened with two ASH abstracts (scRNAseq to assess gene correction outcomes for nula-cel; UltraHDR platform application to beta-thalassemia) .
  • What Went Wrong

    • Operating intensity increased YoY: R&D rose to $18.30M vs $8.68M in Q3’21; G&A rose to $7.85M vs $5.92M, reflecting higher platform and corporate investment .
    • Continued net losses typical of pre-revenue biotech: Q3 net loss $24.68M (EPS $(0.45)), though modestly better than Q2’s $25.94M (EPS $(0.48)) .
    • No clinical efficacy/safety readouts yet; PoC remains a future event (mid-2023), leaving binary event risk and estimate uncertainty for fundamentals .

Financial Results

Income statement and operating metrics (USD Millions, except per-share and shares in Millions)

MetricQ3 2021Q1 2022Q2 2022Q3 2022
R&D Expense ($M)$8.68 $18.25 $17.78 $18.30
G&A Expense ($M)$5.92 $7.71 $9.00 $7.85
Total Operating Expenses ($M)$14.60 $25.96 $26.78 $26.15
Net Loss ($M)$(14.59) $(25.84) $(25.94) $(24.68)
EPS (Basic/Diluted)$(0.28) $(0.48) $(0.48) $(0.45)
Weighted Avg Shares (M)52.77 54.01 54.57 55.21
SBC – R&D ($M)$0.82 $1.37 $1.26 $1.25
SBC – G&A ($M)$1.55 $1.97 $2.10 $1.96

Balance sheet and liquidity (USD Millions)

MetricQ1 2022Q2 2022Q3 2022
Cash & Cash Equivalents ($M)$185.07 $75.17 $56.39
Marketable Securities – Current ($M)$154.11 $247.12 $235.29
Marketable Securities – Non-Current ($M)$12.93 $5.99 $13.40
Total Assets ($M)$378.61 $353.79 $334.85
Stockholders’ Equity ($M)$361.30 $338.46 $316.45
Cash, Cash Eq. & Mkt. Sec. (company disclosure) ($M)$352.10 $328.30 $305.10
Cash Runway (management)“into Q4 2024” “into Q4 2024” “into Q4 2024”

Notes:

  • The company reported operating expenses and net loss; no product revenue line items were presented in the period financials (pre-revenue biotech) .

KPIs and operating updates

KPIQ1 2022Q2 2022Q3 2022
Nula-cel clinical statusOn track to first dose in H2 2022; PoC in 2023 First patient dosed; PoC mid-2023 Recently dosed first patient; enrollment ongoing; PoC mid-2023
Regulatory/DesignationsFDA Fast Track; prior Orphan Drug Fast Track noted
ManufacturingWuXi Advanced Therapies partnership for CMC scale-up
External visibilityASGCT oral (GPH102); CEDAR TIP poster Presented GPH102 preclinical data at ASGCT Two ASH abstracts (scRNAseq for nula-cel; beta-thalassemia platform)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Nula-cel initial PoC data timingQ1 2022 → Q2 20222023 (initial PoC) Mid-2023 Narrowed timing window (more specific)
Nula-cel initial PoC data timingQ2 2022 → Q3 2022Mid-2023 Mid-2023 (on track) Maintained
Cash runwayQ1 2022Into Q4 2024
Cash runwayQ2 2022Into Q4 2024 Maintained
Cash runwayQ3 2022Into Q4 2024 Maintained

Earnings Call Themes & Trends

Note: No Q3 2022 earnings call transcript was available in our document set; themes below are derived from company press releases.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2022)Trend
Clinical execution (nula-cel in SCD)Q1: On track to first dose H2’22; PoC in 2023 . Q2: First patient dosed; PoC mid-2023 .Recently dosed first patient; enrollment ongoing; PoC mid-2023 .Progressing to execution, timeline maintained
Manufacturing/CMCQ1: —. Q2: —.WuXi partnership to support manufacturing, testing, validation for nula-cel .De-risking scale-up
Regulatory designationsQ1: FDA Fast Track; prior Orphan Drug . Q2: Fast Track noted .Stable
Platform/pipeline (GPH102)Q1: ASGCT oral presentation accepted . Q2: GPH102 preclinical data presented; IND targeted mid-2024 .Beta-thalassemia abstract accepted for ASH (UltraHDR platform) .Steady advancement/visibility
Cash/liquidityQ1: $352.1M; runway into Q4’24 . Q2: $328.3M; runway into Q4’24 .$305.1M; runway into Q4’24 .Cash burn as planned; runway reiterated

Management Commentary

  • “We are pleased to have recently dosed our first patient with nula-cel, marking the first time an investigational therapy designed to correct a genetic mutation has been administered to a patient. We continue to enroll patients in CEDAR and look forward to reporting initial clinical proof-of-concept data in mid-2023.” — Josh Lehrer, M.D., M.Phil., CEO .
  • “We are excited to partner with WuXi Advanced Therapies to support the manufacturing of nula-cel as we scale and work to develop and deliver our potentially curative therapy for sickle cell disease…” — Josh Lehrer, CEO .

Q&A Highlights

  • No Q3 2022 earnings call transcript was available in our document corpus; no Q&A details to report. The analysis above relies on the company’s press release disclosures .

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2022 EPS/revenue was unavailable for GRPH at the time of this analysis; no estimate-based beats/misses could be determined.
  • With no product revenue and losses driven by R&D/G&A, estimate revisions (where tracked) typically hinge on operating expense cadence and cash runway; management reiterated runway into Q4 2024, suggesting limited change to liquidity assumptions absent clinical readouts .

Key Takeaways for Investors

  • The nula-cel program reached a key execution milestone with first-patient dosing; PoC in mid-2023 is the defining binary catalyst over the next few quarters .
  • Manufacturing/CMC risk moderated via WuXi partnership, which supports scaling toward late-stage development and potential commercialization .
  • Liquidity remains solid for a clinical-stage biotech ($305.1M cash and securities; runway into Q4’24), providing runway through the PoC inflection .
  • Operating spend rose YoY as the company invests in clinical execution and platform build-out; Q3 net loss improved modestly vs Q2 .
  • Scientific and platform visibility continue via ASH (nula-cel scRNAseq methods; UltraHDR in beta-thalassemia) and earlier ASGCT disclosures (GPH102), which could help frame external expectations ahead of PoC .
  • Pre-revenue status and lack of interim efficacy data keep the story event-driven; position sizing should reflect binary risk into PoC timing .

Sources: Q3 2022 8-K earnings press release and financial statements ; Q2 2022 8-K earnings press release and financials ; Q1 2022 8-K earnings press release and financials .