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Tyra Biosciences, Inc. (TYRA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered key clinical and regulatory milestones: IND clearances for Phase 2 TYRA-300 in intermediate‑risk NMIBC (SURF302) and pediatric achondroplasia (BEACH301), plus strong mUC interim efficacy (54.5% confirmed PR at ≥90 mg QD; 100% DCR) and favorable tolerability versus pan‑FGFR inhibitors .
  • Financially, net loss was $25.6M and diluted EPS was -$0.43, improving year over year from -$0.53; cash, cash equivalents and marketable securities were $341.4M with runway “through at least 2027” .
  • EPS beat Wall Street consensus (-$0.473*) and revenue was expected at $0.0* given development-stage status; operating expenses rose sequentially on clinical progress (R&D $22.2M; G&A $7.6M) .
  • Near-term stock reaction catalysts: Phase 2 dosing starts targeted for Q2 2025 across BEACH301 (ACH), SURF302 (NMIBC), and SURF431 (HCC); continued SURF301 dose optimization in mUC with a differentiated safety/efficacy profile .

What Went Well and What Went Wrong

What Went Well

  • IND clearances and multi‑program advancement: Phase 2 NMIBC (SURF302) and Phase 2 achondroplasia (BEACH301) cleared; TYRA-430 Phase 1 IND cleared for HCC .
  • Strong interim mUC efficacy and tolerability: 6/11 (54.5%) confirmed PRs at ≥90 mg QD; 100% disease control; few FGFR2/FGFR1 toxicities; no ≥Gr4 TRAEs; only one Gr3 DLT (diarrhea) and one TRAE‑related discontinuation (ALT) .
  • Management conviction and platform validation: “Our conviction in TYRA‑300 has never been stronger” and plan to pursue best‑in‑class outcomes across oncology and skeletal dysplasia .

What Went Wrong

  • Sequential OpEx and net loss increase: Q4 total OpEx rose to $29.7M (from $28.6M in Q3), net loss widened to $25.6M (from $24.0M in Q3) as clinical activity intensified .
  • Cash balance declined sequentially: Cash, CE and marketable securities fell from $360.1M (Q3) to $341.4M (Q4), though runway extended to at least 2027 .
  • ACH dosing timeline pushed: First child dosing shifted from Q1 2025 (prior expectation) to Q2 2025, reflecting revised operational timelines .

Financial Results

Quarterly Comparison

MetricQ2 2024Q3 2024Q4 2024
R&D Expense ($USD Millions)$18.0 $22.7 $22.2
G&A Expense ($USD Millions)$5.5 $5.9 $7.6
Total Operating Expenses ($USD Millions)$23.5 $28.6 $29.7
Interest and Other Income ($USD Millions)$4.8 $4.6 $4.2
Net Loss ($USD Millions)$18.7 $24.0 $25.6
Diluted EPS ($USD)-$0.32 -$0.41 -$0.43
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$373.8 $360.1 $341.4

Year-over-Year (Q4)

MetricQ4 2023Q4 2024
R&D Expense ($USD Millions)$20.7 $22.2
G&A Expense ($USD Millions)$5.0 $7.6
Net Loss ($USD Millions)$22.8 $25.6
Diluted EPS ($USD)-$0.53 -$0.43

Results vs Estimates (Wall Street, S&P Global)

MetricQ4 2024 ActualQ4 2024 Consensus# of Estimates
Diluted EPS ($USD)-$0.43 -$0.473*7*
Revenue ($USD Millions)N/A (no product revenue reported) $0.0*5*

Values with * were retrieved from S&P Global.

KPIs (Clinical Program Highlights – SURF301 mUC, as of 8/15/2024 cutoff)

KPIQ4 2024
Confirmed PR rate at ≥90 mg QD (FGFR3+ mUC)54.5% (6/11)
Disease Control Rate (≥90 mg QD)100%
Related SAEs (all doses 10–120 mg QD)4 events (10%); none ≥Gr4
Dose-Limiting Toxicities1 Gr3 diarrhea at 90 mg QD
TRAE-related discontinuations1 Gr3 ALT at 90 mg QD
Phase 1 enrollment (all tumor types)41 patients

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti‑year“Through at least 2026” (Q3) “Through at least 2027” (Q4) Raised
BEACH301 (ACH) – first child dosingQ1/Q2 2025Q1 2025 expected Q2 2025 target Lowered (timing pushed)
SURF302 (NMIBC) – IND status and first patient dosing2024/Q2 2025IND submission before YE 2024 IND cleared; first patient Q2 2025 Raised (regulatory) + New dosing timeline
SURF431 (HCC) – first patient dosingQ2 2025Not specified in prior QsFirst patient Q2 2025 New

Earnings Call Themes & Trends

Note: No standard Q4 earnings call transcript was available; we analyzed Tyra’s Oct 25, 2024 conference call presenting SURF301 interim data (other‑transcript) alongside Q2/Q3 earnings materials .

TopicPrevious Mentions (Q2 & Q3)Current Period (Q4)Trend
Product performance (TYRA‑300 mUC)Anticipated SURF301 initial results 2H24; late‑breaking data reported at ENA (54.5% PR ≥90 mg QD; 100% DCR) Reinforced efficacy with swimmer/waterfall plots; dose‑response; 3 ongoing PRs; all patients showed regression at first scan Improving evidence; de‑risking efficacy
Safety/tolerability vs pan‑FGFRAim to avoid FGFR1/2 toxicities; interim noted infrequent FGFR1/2 toxicities Minimal phosphate changes ≤90 mg; low rates of stomatitis/CSR; no ≥Gr4 TRAEs; 1 DLT (Gr3 diarrhea) Favorable relative to erdafitinib
Regulatory/IND progressPlanned NMIBC IND before YE 2024; ACH IND cleared in Oct NMIBC IND cleared; Phase 2 starts targeted for Q2 2025 across programs Advancing; timelines clarified
R&D executionBuilding clinical programs across TYRA‑300/200/430 Parallel paths in mUC, NMIBC, ACH; TYRA‑200 SURF201 enrolling; TYRA‑430 Phase 1 to initiate Broadening pipeline execution
Cash runway/financing$373.8M (Q2); $360.1M (Q3); runway to at least 2026 $341.4M; runway extended to at least 2027 Runway extended despite spend

Management Commentary

  • “Our conviction in TYRA‑300 has never been stronger and we are working diligently to advance this potential best‑in‑class agent…into three Phase 2 studies in NMIBC, ACH and mUC.” – Todd Harris, CEO .
  • “We benchmarked our clinical activity against the erdafitinib label…reported a 54.5% clinical activity rate with 6 out of 11 confirmed partial responses at 90 mg QD or greater…TYRA‑300 is generally well tolerated with infrequent FGFR2 and FGFR1 associated toxicities.” – Todd Harris (SURF301 call) .
  • “Minimal changes in phosphate levels occurred at the dose of 90 mg and below…exposure at doses of 90 mg exceeded the FGFR3 IC90 target coverage…all patients saw radiographic regression at the first scan time point.” – Executive remarks on PK/PD and efficacy .

Q&A Highlights

  • Safety signals and hepatic labs: Management noted ALT/AST elevations broadly similar to pan‑FGFR labels; monitoring and mitigation strategies are well‑developed; nails/phosphate/eyes/skin toxicities markedly less prominent with TYRA‑300 at 60–90 mg versus erdafitinib .
  • Development paths and dosing: Team emphasized continued dose optimization in SURF301, NMIBC Phase 2 at ~60 mg range, and lower dosing planned for ACH given tolerability data .

Estimates Context

  • Q4 2024 EPS beat consensus: Actual -$0.43 vs consensus -$0.473*; 7* EPS estimates contributed to consensus .
  • Revenue consensus was $0.0* in Q4 2024 given development-stage status; the company did not report product revenue in Q4 .
  • With Phase 2 activations across three programs and ongoing SURF301, OpEx trajectories are likely to be a focus for estimate revisions (R&D and G&A rose sequentially in Q4) .

Values with * were retrieved from S&P Global.

Key Takeaways for Investors

  • TYRA‑300’s selective FGFR3 profile is showing de‑risked efficacy and a differentiated tolerability vs pan‑FGFRs in late‑line mUC, supporting Phase 2 expansion and potential best‑in‑class positioning .
  • Regulatory momentum: NMIBC and ACH Phase 2 INDs cleared; three parallel Phase 2 starts targeted for Q2 2025 (ACH, NMIBC, HCC), setting clear near‑term catalysts .
  • Financial runway extended to at least 2027, providing capacity to execute multi‑program clinical plans without near‑term financing overhang .
  • Watch for continued SURF301 dose optimization and confirmatory efficacy/safety updates; tolerability advantage vs erdafitinib is central to the narrative .
  • Short‑term trading: Potential upside around Phase 2 first‑patient dosings and further mUC data; any safety surprises or timeline slips (e.g., dosing pushes) are key risks .
  • Medium‑term thesis: If NMIBC shows strong CRs at lower doses with improved tolerability and ACH demonstrates meaningful AHV and functional improvements, TYRA‑300 could unlock multi‑indication value with a precision profile difficult for pan‑FGFRs to match .

Sources

  • Q4/FY2024 press release and financial statements .
  • 8‑K Item 2.02 filing with Exhibit 99.1 .
  • Q3 2024 press release and 8‑K .
  • Q2 2024 press release and 8‑K .
  • Q4 2024 additional press releases (ACH IND clearance; SURF301 interim PoC) .
  • Oct 25, 2024 SURF301 conference call transcript (other‑transcript) .
  • S&P Global consensus (EPS and revenue) for Q4 2024 (asterisk‑marked values).