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Tyra Biosciences, Inc. (TYRA)·Q1 2024 Earnings Summary

Executive Summary

  • TYRA ended Q1 2024 with cash, cash equivalents, and marketable securities of $382.5M, extending runway “through at least 2026” and supporting multiple Phase 2 preparations; net loss per share was $(0.35) versus $(0.28) a year ago .
  • Pipeline milestones maintained: SURF301 Phase 1 initial results expected in 2H24 and IND submission for TYRA-300 in pediatric achondroplasia in 2H24; Phase 1 SURF201 for TYRA-200 is enrolling .
  • Board strengthened with appointments of Drs. Susan Moran and Michael Rothenberg, adding deep FGFR and targeted oncology expertise; investor engagement expanded via multiple conferences .
  • Against consensus EPS from third-party sources, TYRA delivered a significant beat: actual EPS $(0.35) vs consensus $(0.46), +$0.11 surprise; revenue not reported (pre-revenue biotech). S&P Global consensus was unavailable due to access limitations .

What Went Well and What Went Wrong

What Went Well

  • Strong liquidity following February 2024 $200M private placement; Q1 cash and marketable securities totaled $382.5M, supporting execution through at least 2026 .
  • Pipeline execution on track: “TYRA-300 clinical profile continues to mature” in SURF301, with Part B dose expansion to support Phase 2 in NMIBC and mUC; ACH IND submission remains on track for 2H24 .
  • Board upgrades bring domain expertise in FGFR biology and targeted oncology, reinforcing program strategy and potential value creation .
  • Management quote: “We believe this work will support future Phase 2 studies in NMIBC and metastatic urothelial carcinoma, where we see tremendous opportunity for an oral FGFR3-selective inhibitor.” — Todd Harris, CEO .

What Went Wrong

  • Increased OpEx: R&D rose to $17.2M from $10.4M YoY and G&A to $5.1M from $3.9M YoY, expanding quarterly net loss to $18.2M from $11.9M YoY .
  • No formal financial guidance metrics (revenue/margins) provided; visibility remains primarily program milestones and cash runway .
  • Earnings call transcript not available in filings or document set, limiting Q&A insight and detailed analyst dialogue in the period [ListDocuments earnings-call-transcript 2024-01-01 to 2024-06-30 returned none].

Financial Results

MetricQ3 2023Q4 2023Q1 2024
Revenues ($USD Millions)
Net Loss ($USD Millions)$(21.152) $(22.830) $(18.192)
Net Loss per Share ($)$(0.49) $(0.53) $(0.35)
R&D Expense ($USD Millions)$19.271 $20.677 $17.203
G&A Expense ($USD Millions)$4.692 $4.957 $5.119
Total Operating Expenses ($USD Millions)$23.963 $25.634 $22.322
Interest and Other Income, net ($USD Millions)$2.811 $2.804 $4.130
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$215.652 $203.469 $382.462
Total Assets ($USD Millions)$238.358 $225.857 $404.741
Total Stockholders’ Equity ($USD Millions)$222.170 $204.262 $389.879

Estimate comparison (EPS):

MetricQ1 2024
EPS Actual ($)$(0.35)
EPS Consensus ($)$(0.46)
Beat/Miss ($)+$0.11 (Beat)

Notes: S&P Global consensus unavailable due to access limitations; third-party aggregation cited above. Revenue not reported in statements of operations, consistent with pre-revenue status .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
SURF301 Phase 1 initial results timing2H 2024Initial results expected 2H 2024 (Q4 update) Initial results expected 2H 2024 Maintained
TYRA-300 ACH IND submission2H 2024IND submission on track for 2H 2024 IND submission on track for 2H 2024 Maintained
Cash runwayThrough at least 2026Through at least 2026 (pro-forma >$400M) Through at least 2026 with $382.5M cash/marketable securities Maintained
TYRA-200 SURF201 statusOngoingPhase 1 to initiate by YE’23; enrolling/dosing as of Q4 2023 Phase 1 SURF201 continued to advance; enrolling/dosing Maintained

Earnings Call Themes & Trends

Note: Q1 2024 earnings call transcript not available in filings/document set searched; themes derived from company press releases for Q3 2023, Q4 2023, and Q1 2024.

TopicPrevious Mentions (Q-2: Q3 2023)Previous Mentions (Q-1: Q4 2023)Current Period (Q1 2024)Trend
R&D execution (SURF301)Dose expansion/escalation ongoing; multi-dose schedule to inform mUC/NMIBC/ACH Part A escalation complete; Part B evaluating once/twice daily doses Part B dose expansion continues; initial Phase 1 results in 2H24 Progressing to Phase 1 readout
ACH program (TYRA-300)Preclinical data presented at ASBMR/ASHG; ODD granted RPD designation granted Jan 2024; Phase 2 design expectations outlined; IND in 2H24 IND submission remains on track for 2H24 Regulatory momentum maintained
TYRA-200 (SURF201)First patient expected by YE’23 Phase 1 initiated; enrolling/dosing FGFR2+ patients Phase 1 continued to advance; enrolling/dosing Steady enrollment
Cash runway/financingStrong cash $215.7M ~$200M PIPE; pro-forma ~$403.5M, runway through at least 2026 $382.5M cash/marketable securities; runway through at least 2026 Robust liquidity
Corporate governanceBoard appointments: Moran, Rothenberg; resignation of Chen Governance strengthened

Management Commentary

  • “During the first quarter of 2024, we focused on execution across our pipeline including delivering on our near-term milestones for TYRA-300 in both achondroplasia and oncology.” — Todd Harris, CEO .
  • “We believe this work will support future Phase 2 studies in NMIBC and metastatic urothelial carcinoma, where we see tremendous opportunity for an oral FGFR3-selective inhibitor.” — Todd Harris, CEO .
  • “Our current cash, cash equivalents and marketable securities on hand allow us to execute on our plans through at least 2026.” — Company statement .
  • Prior quarter CFO emphasis: “Our ability to retain and attract high quality investors reflects the excitement around our pipeline… Our current cash… allow us to execute on our plans through at least 2026.” — Alan Fuhrman, CFO .

Q&A Highlights

  • The Q1 2024 earnings call transcript was not available within the filings/document catalog. Searches across earnings transcript sources and company IR did not yield a transcript for Q1 2024. As a result, specific Q&A themes, guidance clarifications, and tone shifts from the call cannot be cited [ListDocuments earnings-call-transcript 2024-01-01 to 2024-06-30 returned none].

Estimates Context

  • EPS: Actual $(0.35) vs third-party consensus $(0.46), beat by $0.11; S&P Global consensus was unavailable due to access limitations. Revenue was not reported (pre-revenue) .
  • Implications: The EPS beat reflects higher interest income on a larger cash balance post-PIPE and prudent OpEx pacing, despite YoY increases in R&D and G&A .

Key Takeaways for Investors

  • Liquidity is a strategic asset: $382.5M cash/marketable securities supports multiple near-term catalysts (SURF301 initial data, ACH IND) and runway through at least 2026, reducing financing overhang risk .
  • Near-term clinical readout: SURF301 Phase 1 initial data in 2H24 is the primary stock catalyst; dose-scheduling learnings may shape Phase 2 design and perception of TYRA-300’s differentiation in FGFR3+ urothelial/bladder settings .
  • ACH opportunity: ODD and RPD designations plus imminent IND in 2H24 frame a pediatric skeletal dysplasia program with potential regulatory advantages; investor focus will be on safety, growth metrics, and dose selection endpoints .
  • Operating discipline: Despite higher YoY OpEx, the EPS beat vs consensus underscores interest income tailwind and cost control; watch R&D trend as Phase 2 preparations intensify .
  • Governance and talent: Board additions strengthen clinical strategy credibility in FGFR biology and targeted oncology, potentially aiding trial design and regulatory navigation .
  • Risk checklist: Execution risks (enrollment, dosing, readouts), regulatory acceptance of ACH Phase 2 design, and competitive dynamics in FGFR targeting remain key watch items .
  • Trading setup: Ahead of 2H24 data, stock may trade on clinical conference abstracts and ACH IND submission progress; upside skew if SURF301 signals a clean tolerability/efficacy profile, downside if dosing regimens fail to demonstrate compelling activity .

Sources: Q1 2024 press release and 8-K (Item 2.02/exhibit 99.1), Q4 2023 and Q3 2023 8-Ks for trend analysis; board appointments PR; investor conference participation PR; third-party consensus/beat references where S&P Global was unavailable .