Tyra Biosciences, Inc. (TYRA)·Q3 2024 Earnings Summary

Executive Summary

• Tyra delivered a pivotal quarter anchored by interim clinical proof‑of‑concept for TYRA‑300 in FGFR3+ metastatic urothelial cancer: at ≥90 mg QD, confirmed partial responses in 6/11 patients (54.5%) and 100% disease control, with favorable tolerability vs pan‑FGFR inhibitors .
• Q3 2024 financials remained pre‑commercial: net loss widened sequentially to $24.0M on higher R&D activity; cash, cash equivalents and marketable securities were $360.1M, supporting runway “through at least 2026” .
• Operational guidance advanced: IND clearance for Phase 2 achondroplasia (BEACH301), first pediatric dosing expected in Q1 2025; NMIBC Phase 2 IND submission remains on track by year‑end 2024 .
• Key catalysts into 1H25: NMIBC IND filing, BEACH301 first dosing, continued SURF301 dose optimization and additional oncology progress; management tone confident given selectivity/tolerability profile and initial efficacy signals .

What Went Well and What Went Wrong

What Went Well

• TYRA‑300 clinical signal and tolerability: ≥90 mg QD produced 54.5% confirmed PRs and 100% DCR in FGFR3+ mUC with infrequent FGFR1/FGFR2 toxicities; management emphasized selective FGFR3 design to avoid pan‑FGFR toxicities. Quote: “TYRA‑300 demonstrated impressive anti‑tumor activity… and was generally well‑tolerated” .
• Regulatory progress in ACH: FDA IND clearance for BEACH301; study design includes multiple pediatric dose levels with sentinel safety cohort; first child dosing expected Q1 2025 .
• Balance sheet strength: $360.1M cash and equivalents supports execution “through at least 2026,” providing flexibility across three clinical‑stage programs .

What Went Wrong

• Operating losses increased: Q3 net loss rose to $24.0M vs $18.7M in Q2 and $21.2M in Q3’23; driven by R&D ramp and rising G&A (stock‑based comp, personnel) .
• Sequential cash decline: cash decreased from $373.8M (Q2) and $382.5M (Q1) to $360.1M in Q3, reflecting higher operating use despite interest income .
• Consensus estimates: S&P Global Wall Street consensus data were unavailable at time of request due to rate limits; therefore, comparisons to EPS/revenue estimates cannot be made (Values retrieved from S&P Global unavailable).

Financial Results

YoY reference for Q3: Net loss per share was $(0.41) vs $(0.49) in Q3 2023 .

KPIs (Clinical and Operational)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• Strategy and confidence: “These are exciting times at TYRA… [TYRA‑300] can deliver meaningful clinical benefit to heavily pretreated patients… expand into larger studies for mUC and NMIBC… aiming to achieve best‑in‑class annualized growth velocity in achondroplasia” — Todd Harris, CEO .
• Clinical framing: “TYRA‑300 is generally well tolerated with infrequent FGFR2 and FGFR1 associated toxicities” — Todd Harris (special call) .
• Next steps: “We plan to submit a Phase II IND in intermediate‑risk NMIBC, and… initiate a Phase II study in achondroplasia” — Todd Harris (special call) .
• ACH milestone: “IND clearance… a significant milestone… first child… in Q1 2025” — Todd Harris .

Q&A Highlights

• Dose selection/tolerability at lower doses: Analysts probed safety below 60 mg; management noted no hyperphosphatemia and low FGFR‑related toxicities at ≤60 mg; NMIBC doses expected around ~60 mg, ACH potentially ~40–45 mg adult‑equivalent with optimization .
• Project Optimus and regulatory path: TYRA plans to present multiple dose levels with distinct PK per FDA expectations and leverage interim PoC to submit NMIBC IND; no immediate plan for another near‑term data cut .
• Safety nuances: ALT/AST elevations comparable to pan‑FGFR experiences; clinicians expect manageable algorithms for lab abnormalities; notable avoidance of nail/skin/eye toxicities typical of pan‑FGFR agents at 60–90 mg .
• Hyperphosphatemia definition: Clarified CTCAE grading and intervention thresholds; only two cases at 90 mg (one grade 1, one grade 2 with binder) vs much higher rates with pan‑FGFRs .

Estimates Context

• Consensus EPS and revenue comparisons to Wall Street estimates are unavailable due to S&P Global rate limits at the time of retrieval. Values retrieved from S&P Global were unavailable; therefore, estimate‑based beat/miss analysis cannot be provided.

Key Takeaways for Investors

• TYRA‑300’s selective FGFR3 profile is translating clinically: notable PR/DCR rates at ≥90 mg QD with improved tolerability vs pan‑FGFR class, supporting a differentiated positioning in FGFR3‑driven bladder cancer .
• Near‑term regulatory milestones should act as catalysts: NMIBC Phase 2 IND filing by year‑end 2024 and BEACH301 first pediatric dosing in Q1 2025 provide tangible timeline visibility .
• Cash runway to 2026 enables multi‑program execution across oncology (SURF301, SURF201, TYRA‑430) and skeletal dysplasias without near‑term financing pressure, though sequential cash declines warrant monitoring .
• R&D spend is ramping appropriately with program maturation; watch for operating discipline as studies expand and as TYRA refines QD dosing and target PK/PD for Phase 2 designs .
• Comparative safety narrative vs pan‑FGFR agents underpins adoption potential, especially in NMIBC where long‑term tolerability is crucial; lower oral doses could enhance the benefit‑risk .
• Further SURF301 updates (dose optimization, durability) and clarity on Phase 2 endpoints/designs (NMIBC, ACH growth velocity) will shape the medium‑term thesis and valuation trajectory .
• Absence of revenue remains standard for early‑stage biotech; monitor interest income, cash burn, and any BD opportunities to augment runway while programs advance .

Notes:

• Q3 2024 press release and 8‑K Item 2.02 were read in full; an earnings call transcript specific to Q3 was not available in the catalog; a special call transcript (Oct 25) discussing interim clinical results was used to capture management commentary and Q&A -.
• Financial statements and operational highlights are sourced from the company’s Q3, Q2, and Q1 press releases and embedded exhibits in the 8‑K .