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Finch Therapeutics Group, Inc. (FNCH)·Q2 2022 Earnings Summary

Executive Summary

  • Q2 2022 showed minimal collaboration revenue ($0.36M) and a wider net loss ($22.7M; EPS $(0.48)), driven by lower Takeda collaboration revenue and higher G&A; management reiterated PRISM4 enrollment in H2 2022 and advanced FIN-211 toward IND submission in Q4 2022 .
  • Guidance narrative adjusted: cash runway now into Q1 2024 after removing near‑term Takeda milestones pending partner review; PRISM4 topline still targeted for H1 2024, with enrollment-enabling activities ongoing .
  • Clinical/regulatory catalysts: FDA lifted CP101 IND clinical hold in April; additional CP101 data accepted for ACG 2022; continued PRISM4 protocol/manufacturing work to start enrollment .
  • No Q2 earnings call transcript was filed; estimates from S&P Global were unavailable at this time, limiting beat/miss comparison context [functions.ListDocuments] [functions.GetEstimates].

What Went Well and What Went Wrong

What Went Well

  • PRISM4 Phase 3 enrollment-enabling activities progressed (manufacturing, site readiness); Finch expects to proceed with enrollment in H2 2022; topline PRISM4 data anticipated H1 2024 .
  • CP101 efficacy/safety data continued to read out: PRISM‑EXT and a combined PRISM3/PRISM‑EXT post‑hoc analysis reinforced recurrence prevention rates and benign safety profile; translational data accepted for ACG 2022 .
  • Management preparing FIN‑211 IND submission in Q4 2022 and enhanced AUSPIRE Phase 1b design to yield more meaningful behavioral and GI insights; quote: “We look forward to continuing to advance our mission to harness the microbiome…” – Mark Smith, PhD .

What Went Wrong

  • Collaboration revenue declined by $2.5M year over year due to the 2021 Takeda amendment transferring TAK‑524 responsibilities; G&A increased by $2.3M YoY, widening net loss to $22.7M (vs $15.2M YoY) .
  • Management removed near‑term Takeda milestones from runway analysis pending partner review on TAK‑524, reducing runway timing to Q1 2024 and adding uncertainty around non‑dilutive funding .
  • Restructuring costs ($0.9M) and continued platform/manufacturing build heightened expense base; prior period benefitted from $1.8M PPP loan extinguishment gain, absent in Q2 2022 .

Financial Results

Quarterly Financials vs Prior Quarter and Prior Year

MetricQ4 2021Q1 2022Q2 2022
Collaboration Revenue ($USD Millions)$0.806 $0.354 $0.361
Total Revenue ($USD Millions)$0.806 $0.354 $0.361
R&D Expense ($USD Millions)$14.803 $15.530 $13.923
G&A Expense ($USD Millions)$5.065 $9.404 $8.164
Total Operating Expenses ($USD Millions)$19.868 $24.934 $22.990
Net Loss ($USD Millions)$(19.055) $(24.567) $(22.700)
GAAP EPS (Basic/Diluted)$(0.40) $(0.52) $(0.48)
Weighted Avg Shares (Millions)47.492 47.529 47.576

Year-over-Year Comparison (Q2 2022 vs Q2 2021)

MetricQ2 2021Q2 2022
Collaboration Revenue ($USD Millions)$2.830 $0.361
R&D Expense ($USD Millions)$13.964 $13.923
G&A Expense ($USD Millions)$5.882 $8.164
Net Loss ($USD Millions)$(15.169) $(22.700)
GAAP EPS (Basic/Diluted)$(0.32) $(0.48)
Weighted Avg Shares (Millions)47.380 47.576

Balance Sheet / Liquidity KPIs

KPIQ4 2021Q1 2022Q2 2022
Cash & Cash Equivalents ($USD Millions)$133.481 $106.931 $104.673
Total Assets ($USD Millions)$225.369 $204.633 $228.301
Liabilities ($USD Millions)$23.145 $24.842 $69.209
Stockholders’ Equity ($USD Millions)$202.224 $179.791 $159.092
Runway (Mgmt commentary)Mid‑2023 Into Q2 2024 Into Q1 2024 (near‑term Takeda milestones removed)

Segment breakdown: Not applicable; Finch reports collaboration revenue only .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
PRISM4 enrollment start (CP101)H2 2022Proceed with enrollment in H2 2022 after manufacturing/quality updates Expects to proceed with enrollment in H2 2022; enrollment‑enabling activities progressed Maintained
PRISM4 topline timingH1 2024Timing to be provided in future (no prior date) Anticipates topline data in H1 2024 New specific timing
FIN‑211 IND submissionQ4 2022Anticipates submitting IND in Q4 2022 Anticipates submitting IND in Q4 2022 Maintained
AUSPIRE Phase 1b timingTBDGuidance to be provided in future Plans to provide further timing guidance in future Maintained
Cash runwayCompanywideInto Q2 2024 (incl. anticipated non‑dilutive sources) Into Q1 2024 after removing near‑term Takeda milestones pending review Lowered (shortened runway)

Earnings Call Themes & Trends

Note: No Q2 2022 earnings call transcript was identified in filings; themes reflect press releases and prior quarter updates [functions.ListDocuments].

TopicPrevious Mentions (Q4 2021)Previous Mentions (Q1 2022)Current Period (Q2 2022)Trend
Regulatory/legal (FDA)Clinical hold on CP101 IND; response submitted; PRISM4 protocol/statistical requests from FDA FDA lifted clinical hold; proceeding with protocol amendment and release test validation Enrollment‑enabling activities continue; pending FDA feedback on validation package/protocol amendment Improving operational readiness
R&D execution – CP101Positive PRISM3/PRISM‑EXT data; ACG/DDW presentations DDW 2022 presentations planned Translational PRISM‑EXT data accepted for ACG 2022; PRISM4 H2 2022 enrollment plan Steady progress
Partnerships – Takeda (IBD)TAK‑524 transitioned to Takeda; continuing FIN‑525 discovery Anticipated near‑term Takeda milestones (supporting runway) Takeda reviewing TAK‑524 plans/timeline/budget; near‑term milestones removed from runway analysis Deteriorating visibility
Manufacturing/platformNew facility completed; commissioning underway Platform/manufacturing scaling; debt financing Manufacturing and quality activities continue as PRISM4 gating items Ongoing investments
Liquidity/runwayCash $133.5M; runway to mid‑2023 Cash $106.9M; runway to Q2 2024 (incl. debt/milestones/sublease) Cash $104.7M; runway into Q1 2024 (removed near‑term milestones) Slightly weaker
Autism program (FIN‑211)AUSPIRE delayed due to hold; patent portfolio strengthened IND targeted Q4 2022; enhanced AUSPIRE design with placebo IND targeted Q4 2022; AUSPIRE timing to be guided later Maintained

Management Commentary

  • “We are excited by the advances we made this quarter related to our lead program in recurrent C. difficile infection… position us to proceed with enrollment in our PRISM4 Phase 3 trial of CP101 later this year.” – Mark Smith, PhD, CEO .
  • “Additionally, we are preparing to submit the IND for FIN‑211 in children with autism and significant GI symptoms… We look forward to continuing to advance our mission to harness the microbiome…” – Mark Smith, PhD .

Q&A Highlights

  • No Q2 2022 earnings call transcript was found in company filings; Q&A highlights and clarifications are unavailable [functions.ListDocuments].

Estimates Context

  • S&P Global Wall Street consensus estimates for Q2 2022 were unavailable at this time due to a retrieval limit. As a result, formal comparisons to consensus EPS and revenue cannot be provided. Values retrieved from S&P Global.* [functions.GetEstimates]

Key Takeaways for Investors

  • Execution toward PRISM4 enrollment remains the core near-term catalyst; watch for FDA feedback on validation package and protocol amendment and site readiness updates in H2 2022 .
  • PRISM4 topline is now targeted for H1 2024; interim operational updates will drive sentiment before efficacy readout .
  • Liquidity remains adequate with $104.7M cash, but runway shortened to Q1 2024 after removing near‑term Takeda milestones; monitor business development and cost discipline to extend runway .
  • Partnership risk: Takeda’s review of TAK‑524 introduces uncertainty around milestone timing; a negative outcome could pressure liquidity and strategic optionality .
  • FIN‑211 IND submission in Q4 2022 adds a second program catalyst; subsequent AUSPIRE timing guidance will shape the autism thesis .
  • Expense profile is elevated from platform/manufacturing scale‑up and higher G&A; continued focus on restructuring and subleasing can mitigate cash burn .
  • With no transcript and unavailable consensus estimates, trading setups hinge on regulatory/milestone news flow (FDA responses, PRISM4 enrollment start), rather than near‑term financial beats/misses [functions.ListDocuments].

Appendix: Other Relevant Q2 2022 Press Releases and Prior Quarter Context

  • FDA lifted CP101 clinical hold (April 28, 2022) .
  • Q1 2022 update: targeted H2 2022 PRISM4 enrollment; $55M debt facility with $15M drawn; runway into Q2 2024 (incl. anticipated milestones/sublease) .
  • Q4 2021 update: PRISM4 protocol/statistical plan changes requested by FDA; new manufacturing facility completed .