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BI

BioAtla, Inc. (BCAB)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 focused on clinical progress: ozuriftamab vedotin (CAB‑ROR2‑ADC) showed 11 total responses (5 confirmed, including 1 CR) in SCCHN with an 86% DCR; evalstotug (CAB‑CTLA‑4) advanced to unprecedented 1‑gram dosing with manageable safety and new responses at 350 mg with PD‑1 .
  • Operating metrics improved: R&D fell to $18.9M (from $21.7M YoY), G&A to $5.6M (from $7.2M YoY), net loss narrowed to $(23.2)M vs $(27.5)M YoY; cash and equivalents were $80.6M, with runway into 2H 2025 .
  • Guidance: operating cash burn ~$20M in Q2 2024, decreasing in 2H 2024 as ADC trials conclude; R&D expected to decrease near‑term; cash runway maintained into 2H 2025 .
  • Near‑term catalysts: FDA meetings in 2H 2024 for SCCHN (ozuriftamab), UPS (mecbotamab) and BRAF‑mutated melanoma (evalstotug); potential pivotal trial designs and partnership discussions underway .

What Went Well and What Went Wrong

What Went Well

  • Ozuriftamab vedotin in SCCHN produced multiple responses and high DCR with manageable safety; management plans an FDA meeting for potential registrational trial in 2H 2024 .
  • Evalstotug advanced dose escalation with very few immune‑related AEs; new PR at 350 mg + PD‑1 in metastatic melanoma; progressing at 700 mg and 1,000 mg dose levels with intent to enable registrational strategy in first‑line BRAF‑mutated melanoma .
  • Costs trending down: R&D and G&A declined YoY, and company reiterated decreasing cash burn trajectory and runway into 2H 2025 .

Management quotes:

  • “We plan to meet with the FDA in the second half of this year for guidance on a potentially registrational trial [for ROR2 in SCCHN]” .
  • “Very few immune‑related adverse events have been observed to date” with evalstotug .
  • “Cash and cash equivalents… fund operations into the second half of 2025” .

What Went Wrong

  • Melanoma: ozuriftamab at the less‑intense Q2W regimen “did not meet our internal bar,” delaying exploration of more intensive dosing in melanoma despite some responses .
  • Operating cash used rose YoY in Q1 to $30.8M (vs $22.7M), driven by ~$5M seasonal payments; cash declined to $80.6M from $111.5M at year‑end .
  • No reported product revenue; financials consist of operating expenses and net loss, limiting margin analysis versus peers with revenue .

Financial Results

MetricQ1 2023Q3 2023Q4 2023Q1 2024
Revenues ($USD Millions)N/A N/A N/A N/A
R&D Expense ($USD Millions)$21.697 $28.400 $22.674 $18.852
G&A Expense ($USD Millions)$7.233 $6.620 $5.862 $5.605
Total Operating Expenses ($USD Millions)$28.930 $35.020 $28.536 $24.457
Interest Income ($USD Millions)$1.480 $1.734 $1.638 $1.223
Net Loss ($USD Millions)$(27.460) $(33.325) $(26.925) $(23.234)
EPS, Basic & Diluted ($)$(0.58) N/A N/A $(0.48)
Weighted‑Average Shares (Millions)47.578 N/A N/A 48.087
Cash & Equivalents (Period End, $USD Millions)N/A$141.282 $111.471 $80.630

KPIs and Clinical Metrics (Q1 2024 status):

KPIValueNotes
SCCHN ozuriftamab – patients dosedn=33 (21 at 2Q3W; 12 at Q2W) Median 3 prior lines
SCCHN ozuriftamab – responses11 total (5 confirmed incl. 1 CR) DCR 86%
Melanoma ozuriftamab – patients dosedn=29 (Q2W; 1 prior Phase 1 patient at 3 mg/kg Q3W) 27 evaluable; median 2 prior lines
Melanoma ozuriftamab – responses5 total (2 confirmed incl. 1 CR) DCR 67%
Evalstotug CTLA‑4 Phase 1Multiple responses at 350 mg + PD‑1; very few irAEs Treating at 700 mg; 1 g dose cohort in progress
Mecbotamab UPS Phase 2Initial 20 patients enrolled at 1.8 mg/kg 2Q3W FDA meeting in 2H 2024
Mecbotamab NSCLC Phase 233 target‑agnostic patients at 2Q3W Initial clinical benefit evaluation in 2Q 2024

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating Cash BurnQ2 2024 / H2 2024Not quantified previously; expected cash utilization to decrease in 1H 2024 ~$20M in Q2 2024; expected to decrease in H2 2024 New quantification / Lower trajectory
R&D ExpensesNear‑term / 1H 2024Decrease overall in 1H 2024 Continue to decrease overall in near‑term Maintained
Cash RunwayThrough 2H 2025Sufficient to fund operations into 2H 2025 Sufficient to fund operations into 2H 2025 Maintained
Regulatory Milestones2H 2024FDA guidance for UPS (AXL) path in 2H 2024 FDA meetings in 2H 2024 for SCCHN (ROR2), UPS (AXL), BRAF melanoma (CTLA‑4) Expanded scope

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023)Previous Mentions (Q4 2023)Current Period (Q1 2024)Trend
FDA interactions (registrational pathways)Verbal FDA feedback supporting AXL NSCLC registrational path Anticipated FDA guidance for UPS and continued planning Plan FDA meetings for SCCHN (ROR2), UPS (AXL), BRAF melanoma (CTLA‑4) in 2H 2024 Strengthening and broadening
Dosing optimization (2Q3W vs Q2W)Emphasis on Q2W; moving away from 3Q4W due to compliance 2Q3W enrollment across programs; clearing higher CTLA‑4 doses More intensive 2Q3W showed faster disease control in SCCHN; tolerability strong across regimens Shift toward intensive regimens where beneficial
Biomarker agnostic strategyResponses at low expression (AXL, ROR2); potential broader reach Target‑agnostic NSCLC cohort initiated SCCHN responses regardless of ROR2 expression; no companion diagnostic currently expected Validating agnostic approach
Safety/tolerabilityManageable safety across ADCs and CTLA‑4 CTLA‑4: low incidence of irAEs; cleared 700 mg DLT CTLA‑4: very few irAEs; tolerating 1 g dosing; ADCs remain manageable Positive, enabling higher exposures
Strategic partnershipsIntent to form collaborations to accelerate assets Engaging potential pharma partners Advancing discussions on selected assets Ongoing, de‑risking capital needs

Management Commentary

  • “We are encouraged to see multiple responses with single agent ozuriftamab vedotin in a difficult to treat head and neck cancer population… and intend to schedule a meeting with the FDA later this year for a potential randomized registrational trial” — Jay Short .
  • “Another response has now been achieved in a melanoma patient whose evalstotug dose was increased from 70 mg to 350 mg… providing additional evidence that higher doses drive clinical benefit” — Eric Sievers .
  • “We expect our operating cash burn to be approximately $20 million for the quarter ending June 30, 2024… to continue to decrease in the second half of the year” — Richard Waldron .

Q&A Highlights

  • SCCHN durability: Management noted need for further follow‑up; 8 patients remain on treatment, including 2 with responses pending confirmation; expectation bars differ by line of therapy (e.g., ~4+ months late‑line; ~5+ months second line) .
  • AXL UPS timeline: After multiple scans in initial 20 patients, aim to start remaining portion of registrational trial in late 2024, contingent on continued encouraging data .
  • NSCLC line‑of‑therapy context: Study patients were very refractory (median 3 prior lines); extension evaluating target‑agnostic non‑squamous EGFR WT population to inform path in earlier lines .
  • Dosing regimen insights: Both Q2W and 2Q3W were well‑tolerated; 2Q3W showed more rapid disease control; no major PK/PD surprises .
  • Biomarkers: No correlation with HPV status; responses observed regardless of ROR2 expression; no companion diagnostic planned currently .
  • Next‑gen linker (Nectin‑4 ADC): Carbohydrate linker supports higher DAR (e.g., DAR6) with intent to reduce off‑target toxicity and broaden indications (e.g., pancreatic cancer) .

Estimates Context

  • Wall Street consensus EPS and revenue estimates via S&P Global were unavailable at the time of analysis due to access limits; therefore, we cannot provide a comparison to consensus or flag beats/misses for Q1 2024. If needed, we will update once access is restored.

Key Takeaways for Investors

  • Clinical momentum in SCCHN with ozuriftamab (high DCR, confirmed responses) and manageable safety supports a 2H 2024 FDA meeting; randomized registrational study design is the likely next catalyst .
  • CTLA‑4 program continues to de‑risk: very low irAEs and tolerance at high doses suggest potential to deliver higher efficacy with acceptable safety vs legacy CTLA‑4 approaches, with BRAF‑mutated melanoma pivotal plan under FDA review in 2H 2024 .
  • Cost discipline evident: R&D/G&A declines and burn guidance imply improving cash utilization into H2; runway through 2H 2025 reduces near‑term financing risk amid partnering discussions .
  • Dosing strategy matters: 2Q3W regimen appears to deliver faster control in SCCHN; expect dosing optimization to feature in future trial designs and combination strategies .
  • Biomarker‑agnostic signals (responses irrespective of target expression) could expand addressable populations and simplify trial enrollment/market access over time .
  • Watch for multi‑asset catalysts in 2H 2024: FDA feedback across ROR2 (SCCHN), AXL (UPS), CTLA‑4 (melanoma); Phase 1 TCE (BA3182) full data; Nectin‑4 IND cleared with differentiated linker .
  • Trading setup: stock may respond to regulatory clarity (registrational pathways) and additional efficacy data readouts; near‑term volatility likely around FDA meetings and any partnership announcements .