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BioAtla, Inc. (BCAB)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 net loss improved to $21.1M from $35.8M YoY and from $23.2M in Q1; net loss per share improved to ($0.44) vs ($0.48) in Q1, reflecting lower R&D and G&A spend .
  • Cash used in operations declined to $19.0M in Q2 vs $30.8M in Q1; cash and equivalents ended at $61.7M, with runway guided through Q3 2025 .
  • FDA granted Fast Track Designation for ozuriftamab vedotin (CAB‑ROR2‑ADC) in SCCHN; company anticipates an FDA meeting for a potential registrational trial in 2H 2024 .
  • Evalstotug (CAB‑CTLA‑4) demonstrated consistently low immune‑related adverse events across Phase 1/2; initial Phase 2 melanoma data readout targeted for 2H 2024 .
  • Bold catalyst: cash burn came in better than company guidance at $19.0M vs ~$20M guided for Q2, reducing financing overhang risk in the near term .

What Went Well and What Went Wrong

What Went Well

  • Fast Track for ozuriftamab vedotin in SCCHN; management: “We are pleased to receive Fast Track Designation… and are on track to meet with the FDA this year” .
  • Evalstotug safety profile: combined Phase 1/2 safety (n=40) showed low Grade 3 irAEs (4/40) with no Grade 4/5 events, enabling combination strategies; CEO: “potentially best‑in‑class CTLA‑4 antibody” .
  • NSCLC program (mecbotamab vedotin) showed anti‑tumor activity across KRAS variants and a trend for improved OS vs wild‑type; a complete response maintained >2 years in combination with PD‑1 .

What Went Wrong

  • No product revenue; continued operating losses ($21.1M net loss in Q2), underscoring reliance on external capital/partnerships .
  • Clinical programs still require FDA alignment on registrational trial design; UPS and SCCHN pathways subject to upcoming meetings and Project Optimus considerations .
  • Business development not yet signed; while confidence is high, timelines and asset selection remain uncertain, a potential overhang .

Financial Results

MetricQ4 2023Q1 2024Q2 2024
R&D Expense ($USD Millions)$22.674 $18.852 $16.198
G&A Expense ($USD Millions)$5.862 $5.605 $5.774
Total Operating Expenses ($USD Millions)$28.536 $24.457 $21.972
Net Loss ($USD Millions)$(26.925) $(23.234) $(21.072)
Net Loss per Share (Basic & Diluted)—$(0.48) $(0.44)
Operating Cash Burn ($USD Millions)$29.8 $30.8 $19.0
Cash & Cash Equivalents ($USD Millions)$111.471 $80.630 $61.662

Notes: BioAtla did not report product revenue for these periods; margin analysis is not applicable given lack of revenue .

KPIs (Clinical and Cash Execution)

KPIQ4 2023Q1 2024Q2 2024
Ozuriftamab SCCHN Responses (evaluable patients)Data readouts anticipated; trials fully enrolled 11 responses among 29 evaluable SCCHN patients; DCR 86% reported in Q1 11 total responses among 29 evaluable to date; Fast Track received
Evalstotug Safety (combined Phase 1/2)Cleared DLT at 700mg; preparing initial Phase 2 readout Low incidence of immune‑related AEs consistent with prior reports Grade 3 irAEs: 4/40; no Grade 4/5; consistency across Ph1/2
Mecbotamab NSCLC (KRAS subgroup)Expansion cohort on track; initial benefit evaluation planned Study tracking NSCLC target‑agnostic cohort 5/18 responders among KRAS‑mutant; OS trend vs wild‑type; CR >2 years in combo
Operating Cash Burn$29.8M $30.8M $19.0M (better than ~$20M guide)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent Guidance/ActualChange
Operating Cash BurnQ2 2024~$20M (guided on May 14) $19.0M actual Beat (lower than guided)
Cash RunwayThrough 2025Fund operations into 2H 2025 Fund operations through Q3 2025 Maintained (more specific timing)
R&D ExpensesNear-termDecrease overall near-term Continue to decrease near-term Maintained
Cash UtilizationQ3 2024—Expect further reduction in overall cash utilization New
Partnerships (BD)2024Engaging with potential partners “Fairly confident” in one or more collaborations in 2024 Maintained (confidence reiterated)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2: Q4’23)Previous Mentions (Q-1: Q1’24)Current Period (Q2’24)Trend
Regulatory interactionsPreparing Phase 2/registrational‑enabling datasets; Q2 readouts planned Anticipate FDA meetings for SCCHN and melanoma; UPS guidance in 2H FDA Fast Track for ozuriftamab; anticipating FDA meetings for registrational paths Advancing
Safety profile (Evalstotug)Cleared DLT at 700mg; low irAE expectations Low incidence of immune‑mediated AEs consistent with prior reports Grade 3 irAEs 4/40, no Grade 4/5; consistent Ph1/2 Positive/Consistent
NSCLC KRAS signal (Mecbotamab)Expansion cohort on track for benefit evaluation Continued assessment in target‑agnostic cohort Responders 5/18 KRAS‑mutant; OS trend vs wild‑type; durable CR >2 yrs Maturing efficacy signal
Cash burn discipline$29.8M in Q4; runway into 2H’25 Guided ~$20M for Q2; runway into 2H’25 $19.0M actual; expect further reduction in Q3; runway through Q3’25 Improving
BD/PartnershipsEngaging with potential partners to accelerate assets Continued discussions; assets prioritized “Fairly confident” in 2024 collaborations; ADCs get most attention Progressing

Management Commentary

  • “We are pleased to receive Fast Track Designation for ozuriftamab vedotin… The company remains well‑positioned for multiple FDA meetings by year end to discuss potentially registrational trials while we continue to advance discussions with potential strategic partners.” — Jay Short, CEO .
  • “We continue to observe low incidence and severity of immune‑related adverse events… Based on our evolving data, we continue to believe [evalstotug] has the potential to be the best‑in‑class CTLA‑4 antibody.” — Jay Short, CEO .
  • “Among the 18 evaluable patients with known KRAS mutations, we observed 5 responders… one responder whose tumor expressed a mutated KRAS G12C variant and had experienced prior failure of sotorasib.” — Eric Sievers, CMO .

Q&A Highlights

  • UPS registrational strategy: Company discussed Project Optimus dose requirements and accelerated approval bar; plans to review newly enrolled data and update in 2H 2024 .
  • Dosing/compliance: Shifted away from 3Q4 to Days 1 & 8 of a 3‑week cycle due to clinic visit burden; no new safety signals with ADC .
  • BD outlook: Management “fairly confident” to lock one or more deals in 2024; ADC assets are leading in partner interest .
  • NSCLC combo and KRAS: Durable responses in KRAS‑mutant subgroup; preliminary survival advantage vs wild‑type; ongoing genotyping of 21 patients to refine selection .
  • Evalstotug development focus: No plan to expand 700mg monotherapy safety; emphasis is on PD‑1 combinations in melanoma and specified NSCLC mutations .

Estimates Context

  • Wall Street consensus (S&P Global) for Q2 2024 EPS and revenue could not be retrieved due to request limits; therefore, comparison to consensus is unavailable at this time. Results were instead assessed versus company’s own cash burn guidance, which was modestly better than expected ($19.0M vs ~$20M guided) .

Key Takeaways for Investors

  • Cost discipline improving: sequential reductions in R&D/G&A and cash burn enhance runway through Q3 2025, lowering near‑term financing risk .
  • Regulatory momentum: Fast Track for ozuriftamab and multiple anticipated FDA meetings in 2H 2024 could crystallize registrational pathways, key stock catalysts .
  • Differentiated CTLA‑4 risk/reward: Evalstotug’s low irAE profile supports combination use in frontline settings; initial melanoma data in 2H 2024 is a milestone to watch .
  • KRAS‑mutant NSCLC signal: Mecbotamab shows emerging efficacy and survival trends in KRAS‑mutant subgroups, potentially enabling biomarker‑guided development .
  • BD optionality: Management’s confidence in 2024 partnerships, with ADCs in focus, provides non‑dilutive funding potential and validation risk mitigation .
  • Near‑term trading implications: Upcoming ESMO presentation (September) and subsequent medical congress updates offer data catalysts; monitor for FDA meeting outcomes and any BD announcements .
  • Medium‑term thesis: Portfolio breadth (ADC, CTLA‑4, TCE, next‑gen Nectin‑4 ADC) plus improving cash utilization and potential registrational designs support an asymmetric setup contingent on clinical validation in SCCHN, melanoma, and NSCLC .