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Tempest Therapeutics, Inc. (TPST)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 delivered disciplined OpEx with R&D $4.34M and G&A $3.63M; net loss was $7.90M ($0.36 per share) as the company advances late-stage programs .
  • Cash and cash equivalents ended at $32.3M; management reaffirmed runway into Q2 2025, supporting upcoming clinical catalysts .
  • Strategic progress: preparing TPST-1120 (PPARα antagonist) for a pivotal Phase 3 in first-line HCC, with additional preclinical/biomarker evidence and publications; TPST-1495 (EP2/EP4 antagonist) planned for Phase 2 in FAP in 2024, NCI-funded and subject to final approval .
  • Prior period randomized HCC data showed clinical superiority of TPST-1120 triplet vs SOC across multiple endpoints (cORR 30% vs 13.3%; PFS median 7.0 mo vs 4.27 mo; OS HR 0.59 favoring TPST-1120), framing near-term data updates as potential stock catalysts .

What Went Well and What Went Wrong

What Went Well

  • “The positive data and mechanistic analysis presented in the first quarter build on the positive preclinical and clinical data package for TPST-1120… and our confidence in the program as it moves closer to a pivotal Phase 3 study in first-line HCC” — Stephen Brady, CEO .
  • Strengthened scientific validation: AACR RCC preclinical data showed monotherapy tumor growth reduction and enhanced inhibition in combinations; SITC presentation corroborated immune gene expression changes and FFA biomarker alignment with proposed MoA .
  • Runway and focus: $32.3M cash and reaffirmed funding into Q2 2025 provide line-of-sight to 2024 HCC data updates and Phase 3 initiation processes .

What Went Wrong

  • Net loss rose modestly YoY ($7.90M vs $7.64M), reflecting higher G&A from share-based compensation and consulting despite lower R&D, indicating some corporate cost inflation as programs mature .
  • No new randomized HCC efficacy readouts in Q1 materials; near-term value realization hinges on subsequent 2024 data disclosures and regulatory feedback timelines .
  • Ongoing dependence on external milestone timing (FDA feedback for Phase 3 HCC; NCI approval for FAP Phase 2), adding execution risk to the catalyst path .

Financial Results

MetricQ2 2023Q3 2023Q1 2024
Cash and Cash Equivalents ($MM)$17.60 $11.12 $32.33
Operating Loss ($MM)$7.47 $6.59 $7.97
Net Loss ($MM)$7.58 $6.79 $7.90
Diluted EPS ($)$(0.54) $(0.48) $(0.36)
R&D Expense ($MM)$4.42 $4.22 $4.34
G&A Expense ($MM)$3.05 $2.37 $3.63

KPIs – HCC Randomized Study (tempest-1120 triplet vs SOC)

KPIQ2 2023Q3 2023Q1 2024
Unconfirmed ORR (triplet)30.0% (12/40) ——
Confirmed ORR (triplet)17.5% (7/40) 30.0% —
Confirmed ORR (control)10.3% (3/29) 13.3% —
Median PFS (months)—7.00 (triplet) vs 4.27 (control); HR 0.70 —
Overall Survival (HR)—HR 0.59 favoring triplet (median OS not reached, immature) —
On Treatment (%)47.5% (triplet) vs 23.3% (control) 40.0% (triplet) vs 16.7% (control) —
On Study (%)80.0% (triplet) vs 50.0% (control) 72.5% (triplet) vs 46.7% (control) —

Note: Q1 2024 materials emphasized publications/preclinical/mechanistic updates without new randomized efficacy metrics; updated study data expected in 2024 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 2025“Extends runway into 2025” (prelim cash update Nov 2023) “Sufficient resources to fund operations into Q2 2025” Maintained, with added specificity
TPST-1120 – First-line HCC2024/Phase 3 Initiation“Plan to advance into registrational study; partner likely” (Q3 2023) “Plan to advance into Phase 3, subject to FDA feedback; updated randomized data in 2024” Maintained; regulatory qualifier reiterated
TPST-1495 – FAP Phase 22024“Plan to advance TPST-1495 into Phase 2 in FAP, NCI-funded, subject to final approval” (YE 2023) “Plan to advance TPST-1495 into Phase 2 in FAP in 2024, NCI-funded, subject to final approval” Maintained
Endometrial Cancer (TPST-1495 + pembrolizumab)2024 readout“Expect data in 2024” (Q3 2023; YE 2023) “Expect to report combination-arm data in 2024” Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2023, Q3 2023)Current Period (Q1 2024)Trend
HCC first-line efficacy (TPST-1120 triplet)Early randomized signals: improved ORR, strong “on treatment/on study” metrics ; Confirmed superiority with cORR 30%, favorable PFS/OS HR No new randomized efficacy metrics; updated data expected in 2024; advancing toward Phase 3 subject to FDA feedback Progressing to pivotal planning; data updates pending
Biomarker rationale (PD-L1–/β-catenin)Benefit in PD-L1 negative and β-catenin mutant subpopulations; MoA-consistent biomarker data SITC gene-expression/FFA biomarker alignment with proposed MoA Strengthening translational support
Kidney cancer (RCC) opportunityManagement flagged interest in RCC based on earlier signals AACR preclinical data: monotherapy inhibition; enhanced response with chemo/IO combos Expanding indication rationale
TPST-1495 programASCO/Cancer Research Communications outputs; endometrial combo arm enrolling ; continued enrollment in Q3 Phase 2 in FAP planned in 2024 (NCI-funded, subject to approval); endometrial combo data in 2024 Advancing clinical execution
Capital runwayPreliminary cash update extended runway into 2025 Runway into Q2 2025 reaffirmed Stable funding through key catalysts

Management Commentary

  • “The positive data and mechanistic analysis presented in the first quarter build on the positive preclinical and clinical data package for TPST-1120… and our confidence in the program as it moves closer to a pivotal Phase 3 study in first-line HCC” — Stephen Brady, President & CEO .
  • “We were extremely pleased to see the pronounced external validation of the new data showing the clear benefit of TPST-1120 combination therapy compared to standard of care in first-line liver cancer” — Stephen Brady (Q3 2023) .
  • “2023 was a transformative year… [data] set up the program for a pivotal Phase 3 trial. We look forward to 2024 as the year Tempest evolves towards becoming a late-stage clinical organization” — Stephen Brady (Year-end 2023) .

Q&A Highlights

  • Not applicable: no earnings call transcript was available in the document set for Q1 2024 press materials .

Estimates Context

  • Wall Street consensus EPS and revenue estimates via S&P Global were unavailable due to data access limits during this session; therefore, estimate comparisons for Q1 2024 cannot be provided at this time. Management did not provide revenue guidance; the quarter focused on operating expenses, cash runway, and clinical progress .

Key Takeaways for Investors

  • Cash runway into Q2 2025 provides sufficient time for 2024 HCC data updates and Phase 3 initiation processes — a critical de-risking window for TPST-1120 .
  • Prior randomized HCC data showing superiority on cORR, PFS, and OS HR underpin Phase 3 potential; near-term catalysts include updated HCC results expected in 2024 and FDA feedback on pivotal design .
  • Continued mechanistic and biomarker validation (SITC, FFA, gene expression) strengthens the TPST-1120 thesis across liver and potentially kidney cancers, broadening optionality .
  • TPST-1495 maintains momentum with 2024 data milestones (endometrial combo) and a planned, NCI-funded Phase 2 in FAP, adding a second program with potential value inflection .
  • Cost discipline remains evident: R&D decreased YoY while G&A rose on compensation/consulting; monitor operating loss trajectory vs. clinical acceleration to assess burn-rate sustainability .
  • Execution risks center on regulatory feedback timing (HCC Phase 3) and external approvals (NCI for FAP); partnership dynamics may influence funding strategy and timeline .
  • Trading implications: stock likely moves on (i) 2024 HCC update magnitude/durability metrics and (ii) clarity on Phase 3 path/FDA feedback; watch incremental RCC preclinical/early clinical signals and FAP study initiation updates for secondary catalysts .