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BioAtla, Inc. (BCAB)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 delivered a step-change in reported financials on recognition of $11.0M collaboration revenue from the worldwide license of the CAB‑nectin‑4 bispecific T‑cell engager to Context Therapeutics, reducing net loss to $10.6M and EPS to $(0.22) versus $(0.44) in Q2 and $(0.70) in Q3’23 .
  • Clinical momentum: ozuriftamab vedotin (CAB‑ROR2‑ADC) in SCCHN showed median OS ≈9 months (ongoing) and median DOR 4.4 months; FDA provided actionable guidance supportive of a randomized pivotal design with potential accelerated approval pathway; Fast Track designated .
  • Evalstotug (CAB‑CTLA‑4) plus PD‑1 showed tumor reduction in all 8 first‑line melanoma patients (4 responders: 3 PR, 1 CR) with low incidence/severity of irAEs; FDA guidance received to enable Phase 3 trial initiation in 2025 .
  • Mecbotamab vedotin (CAB‑AXL‑ADC) in NSCLC continued to demonstrate antitumor activity and improved median OS among mKRAS variants (12.6 vs 8.7 months in KRAS wildtype), supporting a potential pan‑KRAS strategy; safety manageable, no new signals .
  • Cash and equivalents of $56.5M; runway guided into early 2026, extended by licensing; management reiterated near‑term goal to secure at least one Phase 2 asset collaboration in 2025 as pivotal trials start, a likely stock reaction catalyst .

What Went Well and What Went Wrong

What Went Well

  • FDA engagement and pathway clarity: For ozuriftamab vedotin, the FDA supported the randomized design, investigator’s choice comparators (cetuximab, docetaxel, methotrexate), and endpoints with potential for accelerated approval followed by confirmatory OS in the same trial; dosing schedule (Q2W vs 2Q3W) limited randomized evaluation endorsed at 1.8 mg/kg .
  • Differentiated CTLA‑4 profile: Evalstotug plus PD‑1 achieved tumor reduction in all 8 first‑line melanoma patients with 4 responses (including one CR) and relatively low irAE rates; dose escalation re‑achieved disease control in several cases, enabling higher exposure with acceptable tolerability .
  • Licensing and runway: Recognized $11.0M collaboration revenue from the Context Therapeutics agreement (up to $133.5M aggregate payments, including $15.0M upfront/near‑term), extending cash runway to early 2026; quarterly net cash used fell to $5.1M .

Management quotes:

  • “We believe the company is well‑positioned for two potentially registrational trials in 2025.” — Jay Short .
  • “All eight patients treated with evalstotug plus PD‑1 showed tumor reduction with 4 responders…acceptable tolerability.” — Company release .
  • “We are maintaining our guidance for a potential near‑term collaboration for at least one of our Phase 2 assets.” — Jay Short .

What Went Wrong

  • Limited product revenue base; results hinged on collaboration revenue recognition: prior quarters carried no collaboration revenue, highlighting ongoing dependence on financing/licensing while late‑stage programs mature .
  • R&D prioritization reflects constrained resources: R&D decreased materially as Phase 2 enrollment completed and preclinical programs tapered; trade‑offs may slow breadth of pipeline unless a partner is secured .
  • Dosing schedule optimization remains a gating item for ROR2 ADC pivotal: FDA asked for limited randomized evaluation of Q2W vs 2Q3W, adding complexity/timing risk to pivotal rollout .

Financial Results

MetricQ1 2024Q2 2024Q3 2024
Collaboration and other revenue ($USD Millions)N/A (no collaboration revenue reported) N/A (no collaboration revenue reported) $11.0
Research & Development expense ($USD Millions)$18.9 $16.2 $16.4
General & Administrative expense ($USD Millions)$5.6 $5.8 $5.9
Total operating expenses ($USD Millions)$24.5 $22.0 $22.3
Loss from operations ($USD Millions)$(24.5) $(22.0) $(11.3)
Interest income ($USD Millions)$1.2 $0.9 $0.7
Net loss ($USD Millions)$(23.2) $(21.1) $(10.6)
Net loss per share (basic/diluted, $USD)$(0.48) $(0.44) $(0.22)
Weighted‑avg shares (Millions)48.1 48.2 48.3
Cash & equivalents ($USD Millions)$80.6 $61.7 $56.5

Notes:

  • Year‑over‑year comparison (Q3’24 vs Q3’23): EPS improved from $(0.70) to $(0.22); net loss improved from $(33.3)M to $(10.6)M, aided by collaboration revenue .
  • Estimate comparison: S&P Global consensus EPS/revenue for Q3 2024 was unavailable due to data access limits; thus beats/misses vs sell‑side are not provided.

KPIs (Clinical efficacy and safety highlights):

Program / IndicationKPIValueSource
Ozuriftamab vedotin (CAB‑ROR2‑ADC) — SCCHNMedian OS≈9 months (ongoing)
Ozuriftamab vedotin — SCCHNMedian DOR (confirmed responders)4.4 months
Ozuriftamab vedotin — SCCHNHistorical SOC monotherapy benchmarks (2L+)ORR 6–13%, median OS 5.1–6.9 months (cross‑trial context)
Evalstotug (CAB‑CTLA‑4) + PD‑1 — first‑line melanomaTumor reduction8/8 patients; responses: 3 PR, 1 CR
Evalstotug (CAB‑CTLA‑4)SafetyRelatively low incidence/severity of irAEs; several Grade 3 irAEs responsive to standard tx; no discontinuations due to progression to date
Mecbotamab vedotin (CAB‑AXL‑ADC) — NSCLCMedian OS (mKRAS vs WT)12.6 vs 8.7 months (ongoing)
Mecbotamab vedotin — NSCLCResponses across mKRAS variantsConfirmed responses across 9 mKRAS variants; includes prior G12C failure responder

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayCorporateThrough Q3 2025 Into early 2026 Raised runway
Operating expenses trendNear‑termR&D to decrease as Phase 2s complete Further OpEx reduction expected as trials complete and pivotal paths finalized Maintained/downward trend
Ozuriftamab vedotin — SCCHN pivotal2024–2025FDA meeting 2H 2024; Fast Track FDA supportive of randomized pivotal; limited Q2W vs 2Q3W dose schedule evaluation; Phase 3 in 2025 Firmed path/timing
Evalstotug — melanoma pivotal2024–2025Designing blinded randomized trial; FDA guidance 2H 2024 FDA guidance received; Phase 3 initiation anticipated in 2025 Timeline clarified
Mecbotamab vedotin — NSCLC strategy2024–2025KRAS/mKRAS signal; path to be defined later in 2024 Potential pan‑KRAS strategy; pivotal path under evaluation Strategy evolving
Strategic collaborationNear‑termOn track for one or more collaborations in 2024 Maintaining guidance for near‑term collaboration on at least one Phase 2 asset (timing now framed into 2025 pivotal starts) Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2024)Previous Mentions (Q2 2024)Current Period (Q3 2024)Trend
ROR2 ADC pivotal path (SCCHN)Planning FDA meeting; 11 responses; DCR 86%; tolerance across dosing regimens Fast Track; on track for FDA meeting; ESMO poster planned FDA supportive randomized design; investigator’s choice; limited schedule evaluation at 1.8 mg/kg; accelerated approval potential Visibility improved; path crystallizing
CTLA‑4 efficacy/safetyMultiple responses at 350 mg + PD‑1; low irAEs; 1‑gram dose escalation ongoing Combined Phase 1/2 safety: low Grade 3 irAEs (4/40); initial Phase 2 monotherapy data (stable disease, prolonged PFS) First‑line melanoma: 8/8 tumor reduction; 4 responses incl. CR; FDA guidance to enable 2025 Phase 3 Strengthening efficacy with tolerability
AXL ADC mKRAS strategyUPS registrational first portion completed; NSCLC target‑agnostic cohort pending 33‑patient expansion; responders incl. prior G12C failure; trend to improved OS mKRAS vs WT 21 evaluable mKRAS with responses; median OS 12.6 vs 8.7 months; potential pan‑KRAS strategy Consolidating signal; pivotal path under study
Dosing schedules (Q2W vs 2Q3W)Both regimens evaluated; 2Q3W more intensive; tolerability strong Emphasis on days 1 & 8 regimen; patient compliance considerations FDA‑requested limited randomized comparison; final schedule decision pending Methodical optimization
BD/partnershipsAdvancing discussions across assets On track for collaborations in 2024 Maintaining near‑term collaboration guidance for Phase 2 assets Continuing dialogues
Cash runwayInto 2H 2025 Through Q3 2025 Into early 2026 (post licensing) Extended

Management Commentary

  • “Following recent, positive interactions with the FDA regarding ozuriftamab vedotin and evalstotug, we believe the company is well‑positioned for two potentially registrational trials in 2025.” — Jay Short .
  • “We have now observed 4 responders, including 3 partial responses and 1 complete response with acceptable tolerability and no disease progression observed to date.” — Jay Short, on evalstotug + PD‑1 in first‑line melanoma .
  • “We continue to observe an overall survival benefit among treated patients with mutant KRAS variants compared to KRAS wild type with a median overall survival of 12.6 months compared to 8.7 months.” — Jay Short, on mecbotamab vedotin .
  • “We recognized revenue related to our exclusive worldwide license agreement with Context Therapeutics… including $15 million in upfront and near‑term milestone payments.” — Richard Waldron .

Q&A Highlights

  • Melanoma population scope: While BRAF‑mutated patients remain a key opportunity, the pivotal plan broadened to all first‑line unresectable/metastatic melanoma; SITC data support activity across the broader group .
  • CTLA‑4 dose strategy: Higher exposures appear to drive benefit; active discussion on evaluating 700 mg vs 350 mg with exposure‑response integration; intra‑patient escalation re‑attains disease control .
  • ROR2 pivotal comparators and timing: Investigator’s choice (cetuximab, docetaxel, methotrexate) confirmed; pivotal starts in 2025 with schedule finalization via limited randomized evaluation .
  • Cash and licensing: Cash balance includes $15M upfront; runway into 2026; collaboration expected to share R&D costs in partnered program(s) .
  • NSCLC selection strategy: KRAS genotype and AXL expression both relevant; standard KRAS genotyping could enable straightforward enrichment if signal consolidates .

Estimates Context

  • S&P Global consensus EPS and revenue estimates for Q3 2024 were unavailable at time of analysis due to data access limits; therefore, beats/misses vs sell‑side cannot be determined. As a result, comparisons to consensus are not provided, and any estimate‑linked conclusions should be revisited when data are accessible.
  • Given the $11.0M licensing revenue, reported net loss and EPS were materially better than prior quarters; analysts may adjust forward models to reflect strategic partnering income and reduced near‑term OpEx as Phase 2 programs wind down ahead of pivotal initiations .

Key Takeaways for Investors

  • FDA feedback de‑risked pivotal paths for both ozuriftamab vedotin (SCCHN) and evalstotug (melanoma), setting up 2025 initiation and potential accelerated approval scenarios — a constructive setup for catalysts over the next 6–12 months .
  • Evalstotug continues to differentiate on tolerability at higher exposures, enabling compelling first‑line melanoma activity (including a CR) that could support broader CTLA‑4 utilization with PD‑1s; monitor forthcoming Phase 3 design specifics .
  • Mecbotamab vedotin’s mKRAS signal (12.6‑month median OS) across multiple variants supports a pan‑KRAS strategy; clarity on pivotal design and enrichment criteria (genotype/AXL) is a medium‑term value driver .
  • Financial runway extended into early 2026 post license revenue recognition; this reduces dilution risk ahead of pivotal trial starts and increases negotiating leverage in ongoing BD talks .
  • Near‑term collaboration on at least one Phase 2 asset remains a key management objective and potential stock catalyst; shared development costs and upfront economics could further extend runway .
  • For trading, watch regulatory milestones (protocol agreements, schedule selection for ROR2) and additional melanoma data disclosures; execution on timelines and partner selection likely to drive narrative and price action .
  • Without consensus estimates, reframing valuation hinges on clinical de‑risking and BD optionality; upside paths are tied to accelerated approvals, partnership economics, and continued evidence of differentiated safety/activity profiles .

Sources: Q3 2024 Form 8‑K (Item 2.02 press release and financial tables), Q3 2024 earnings call transcript, prior Q1/Q2 2024 8‑Ks and calls, and July 25, 2024 R&D day press release .