Bioatla, Inc. · NASDAQ:BCAB
Bioatla — Investor Presentation (January 2024)
55 slides from Bioatla's investor presentation, Jan 9, 2024
Slide 1: Conditionally Active Biologics: Transforming Cancer Therapy
Exhibit 99.1 Conditionally Active Biologics: Transforming Cancer Therapy Corporate Presentation January 2024
Slide 2: Important Notices & Disclaimers
Important Notices & Disclaimers This presentation (the “Presentation”) by BioAtla, Inc. (“we”, “us”, “our”, “BioAtla”, or the “Company”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations and financial
Slide 3: BioAtla Overview
© BioAtla is a clinical stage company focused on transforming cancer therapy with Conditionally Active Biologics (CABs) Two Phase 2 CAB-ADCs, Prioritized pipeline one Phase 2 CAB-CTLA-4 Proprietary technology $141.3 million in cash and Clinical readouts for and one Phase 1 dual CAB- cash equivalents
Slide 4: Leadership Team
Leadership Team Chief Financ ial Officer Eric Sievers, M.D. Jay Short, Ph.D. Richard Waldron, M.B.A. Sheri Lydick Chief Medical Officer Chairman, CEO and Cofounder Chief Commercial Officer Chief Financial Officer GeneMedicine, Inc. Bin Zhang, M.D. William Boyle, Ph.D. Monica Sullivan Susie Melody Sr
Slide 5: Board of Directors and Advisors
Board of Directors and Advisors Jay Short, Ph.D. Chairman, Chief Executive Mary Ann Gray, Ph.D. Sylvia McBrinn Susan Moran, MD, MSCE Director Director Director Officer & Cofounder Director Scott Smith Lawrence Steinman, MD Eddie Williams Director Director Director Lawrence Fong, MD James Allison, Ph
Slide 6: Selective and targeted CAB technology widens therapeutic window
Selective and targeted CAB technology widens therapeutic window, thus has the potential to enhance clinical outcomes in multiple tumor types Acidic Cancer Cell Membrane Alkaline Healthy Cell Membrane BioAtla discovered that acidic pH at the cancer cell surface unveils binding sites that are shielded
Slide 7: Broad applicability of BioAtla's CAB platform
Broad applicability of BioAtla’s CAB platform across several antibody types has the potential to treat multiple solid tumors ADCs I/O Antibodies Bispecific TCE Targets: AXL, ROR2 Target: CTLA-4 Target: EpCAM & CD3 CTLA-4 blockade activates effector Widely expressed in a variety of tumor Bispecific a
Slide 8: Focused Pipeline with Broad Applicability of Differentiated CAB Assets
Focused Pipeline with Broad Applicability of Differentiated CAB Assets Designed to Deliver Near-term value IND Enabling Phase 1 Phase 2 CAB Program Target Indications Pre-Clinical Clinical Clinical BA3011 UPS AXL Mecbotamab Vedotin NSCLC CAB-ADCs BA3021 Melanoma ROR2 Ozuriftamab Vedotin SCCHN Melano
Slide 9: I/O Antibody Platform: CTLA-4 (BA3071) – Basket Trial
I/O Antibody Platform: CTLA-4 (BA3071) – Basket Trial
Slide 10: CAB-CTLA4 Selectively Active in Tumor Microenvironment
CAB-CTLA4 Selectively Active in Tumor Microenvironment, thereby Reducing Immune Related Adverse Events (irAEs) Severe irAEs Minimized irAEs Non-CAB CTLA-4 CAB CTLA-4 Normal Cell (alkaline) inhibitors Tumor selective binding anti-CTLA4 anti-CTLA4 CAB-anti-CTLA4 CAB-anti-CTLA4 Cancer cell (acidic) Cyt
Slide 11: CAB BA3071 Effectively Reduces Clinically Relevant GI Toxicity in NHP
CAB BA3071 Effectively Reduces Clinically Relevant GI Toxicity in NHP * Vehicle Control Nivo + IPI Nivo + Ipi 20mg/kg + 15mg/kg Positive Control GI Symptoms Nivo + CAB-BA3071 Liquid feces 20mg/kg + 15mg/kg Non-formed feces Other GI symptoms Nivo: 20mg/kg QW (~14.6mg/kg human dose) + Ipi or BA3071: 1
Slide 12: BA3071 Combination Therapy Dose Escalation
Combination Therapy Phase 1 BA3071 Dose Escalation ongoing (Q3W) Cycle 1 Cycle 2+ Key Objectives: Define safety profile and determine Phase 2 dose and MTD 700 mg Evaluate antitumor activity and immunogenicity (~10mg/kg) Determine PK parameters 350 mg (~5mg/kg) Key Eligibility Criteria: 210 mg CTLA-4
Slide 13: BA3071: Baseline Patient Characteristics
Phase 1 BA3071: Demographics - Baseline Patient Characteristics Median of at least 3 prior lines of treatment Total (N=18) Age, y, mean (range) 65.5 (43 - 79) ECOG Status, n (%) 0 10 (55.6) 1 8 (44.4) # of prior systemic therapies, n (%) 1 5 (27.8) 2 2 (11.1) 3 4 (22.2) ≥4 7 (38.9) Data Cut Date: 15
Slide 14: BA3071: Demographics – Tumor Types
Phase 1 BA3071: Demographics – Tumor Types All patients experienced failure of prior PD1 treatment Total Prior Number Tumor Type Prior Treatment of Tx (N=18) pt, anti-VEGF, anti-PD1 Cervical 1 (5.6) 3 4 (22.2) 4 – 6 anti-PD1 and pt chemotherapies Gastric 1 – 2 anti-PD1 Melanoma 5 (27.8) Uveal 3 (16.
Slide 15: Grade 3+ Adverse Events of Special Interest
Grade 3+ Adverse Events of Special Interest BA3071 Q3W + 7 mg 21 mg 70 mg 210 mg Total 350 mg 700 mg (N=7)* (N=3) nivolumab 240 mg Q3W (N=1) (N=1) (N=3) (N=3) (N=18) Number of subjects with at least one Grade 3+ AESI 0 0 2 0 1 2 5 (27.8) GI Toxicity 0 0 1 0 1 0 2 (11.1) Abdominal pain 0 0 1 0 0 0 1
Slide 16: Grade 3+ Adverse Events of Special Interest
Grade 3+ Adverse Events of Special Interest BA3071 Q3W + 7 mg 21 mg 70 mg 210 mg Total 350 mg 700 mg (N=7)* (N=3) nivolumab 240 mg Q3W (N=1) (N=1) (N=3) (N=3) (N=18) Number of subjects with at least one Grade 3+ AESI 0 0 2 0 1 2 5 (27.8) GI Toxicity 0 0 1 0 1 0 2 (11.1) Abdominal pain 0 0 1 0 0 0 1
Slide 17: BA3071: Confirmed Responses and Stable Disease Among Evaluable Patients
Phase 1 BA3071: Confirmed Responses (n=2) and Stable Disease (n=9) Among 16 Evaluable Patients Uveal melanoma SCLC Cutaneous melanoma Cutaneous melanoma Gastro-esophageal (confirmed PR, 54.3% tumor reduction, post data cut) Cervical Data Cut Date: 15Nov23 BioAtla | Overview 17
Slide 18: BA3071: Meaningful Clinical Benefit in Combination with PD1
Phase 1 BA3071: Meaningful Clinical Benefit at 350 mg in Combination with PD1 Confirmed Partial and Complete Responses Uveal melanoma (PD) Uveal melanoma (SD) Overall Response to date N=5 NSCLC (PD – non-target/new lesion) Complete Response 1 Partial Response 1 Gastro-esophageal Stable Disease 1 (co
Slide 19: Confirmed PR - Gastro-esophageal Cancer
Confirmed PR - Gastro-esophageal Cancer 63-year-old male, stage IV gastro-esophageal cancer HER2 negative, post-FOLFOX, taxane, TKI, anti-PD1 and anti-VEGFl BioAtla | Overview 19 Baseline - July 31,2023 On Treatment - October 23, 2023
Slide 20: Confirmed CR - Cervical Cancer
Confirmed CR - Cervical Cancer 43-year-old female, stage IV cervical cancer HPV+16 positive, post-platinum, taxane, anti-PD1 and anti-VEGF Baseline – March 23, 2023 On Treatment – August 9, 2023 “No enlarged mediastinal, hilar or axillary lymph nodes are present. There is persistent resolution “Mult
Slide 21: BA3071-001 Dose Titration
BA3071-001 Dose Titration Ongoing 3 patients dosed at 700 mg Q3W in combination with nivolumab Cycles Overall Cancer Type Age Prior Tx Adverse Events DLT Disposition Completed Response G1 fever and chills; Renal cell 78 5 No 6 SD Ongoing G2 transient hypoxia DC - Subject Gastro-esophageal 66 4 G1 fe
Slide 22: BA3071 Mono and Combo Study Currently Underway
BA3071 Phase 2 Mono and Combo Study Currently Underway Study designed for multiple approval paths Treatment Refractory: • Monotherapy assessment 350 mg • melanoma • Evaluating path for potential • carcinomas accelerated approval • Further characterize safety and efficacy Monotherapy and Potential hi
Slide 23: CAB-AXL-ADC Platform BA3011 Mecbotamab Vedotin: Sarcoma and NSCLC
CAB-AXL-ADC Platform BA3011 Mecbotamab Vedotin: Sarcoma and NSCLC
Slide 24: Potential market opportunity in UPS
Potential market opportunity in undifferentiated pleomorphic sarcoma (UPS) newly diagnosed Targeted therapies 2nd most patients / year people in the Av Ava ail ila abl ble e T Tre rea attm me en ntt:: specifically common Soft (U.S.) – majority ~15% ~200K 0 >540K U.S. living with approved to treat Ti
Slide 25: UPS: ORR 50%, Median PFS 10.9 months
Undifferentiated Pleomorphic Sarcoma (UPS): ORR 50%, Median PFS 10.9 months Phase 1 & Phase 2, part 1 change in target lesion and progression free survival (1.8mg/kg; n=10) Change Target Lesion From Baseline (%) Progression-free Survival Events Median (mos) (95% PFS 3mo n(%) CI) % (95%CI) All Patien
Slide 26: Phase 2 Topline Interim Analysis Results Confirm Phase 1 Signal
Phase 2, part 1 Topline Interim Analysis Results Confirm Phase 1 Signal Following BA3011 in remaining sarcoma subtypes Sarcoma Subtype # of Pt PFS rate PR/CR Leiomyosarcoma 19 28.8% (Q2W) 0 1 13 10.3% (3Q4W) ‘Go’ if ≥1 CR/PR Synovial 7 35.7% 0 or PFS rate at 3 months ≥40%; Liposarcoma 8 62.5% 0 Oste
Slide 27: Continued promising safety and tolerability profile in sarcoma
Continued promising safety and tolerability profile in sarcoma Phase 2 at the RP2D 1.8 mg/kg Q2W BA3011 BA3011 + Opdivo Characteristic (N=73) (N=26) § No treatment-related deaths Any Adverse Events (AEs) 69 (94%) 24 (92%) § Few treatment-related SAEs, consistent with 1 2 Related AEs with CTCAE Grade
Slide 28: Potentially Registrational UPS Study Design
Phase 2 Potentially Registrational UPS Study Design • UPS Phase 2, part 2 potentially registrational study – Enrolling total of ~80 AXL-expressing UPS patients in Phase 2, part 2 o FDA supportive of investigating a more frequent dosing regimen (3Q4W 44% and 2Q3W 38% increased exposure over Q2W) o Fi
Slide 29: Potential market opportunity in metastatic NSCLC
Potential market opportunity in metastatic NSCLC n ne ewly wly di dia ag gn no os se ed d p pa at tiie en nt ts s / / ye yea ar r p pe eo op plle e i in n t th he e Av Ava ail ila abl ble e T Tre rea attm me en ntt:: ~200K ( (U U.S .S. .) ) – – m ma aj jor ori ity ty >540K ~200K >540K U U.S .S. . ll
Slide 30: AXL expression is associated with poor prognosis in metastatic NSCLC
AXL expression is associated poor prognosis in metastatic NSCLC In a cohort of 98 patients with metastatic NSCLC, Lower overall survival (OS) in patients with early stage, surgically resected lung adenocarcinoma OS was significantly worse for those patients with high AXL expression by IHC with high
Slide 31: BA3011-002 Non-Small Cell Lung Cancer
BA3011-002 Non-Small Cell Lung Cancer Multicenter, Phase 2, open-label trial evaluating the efficacy and safety of BA3011 alone and in combination with nivolumab Patient disposition: Primary endpoint: • Confirmed locally advanced or metastatic BA3011 • ORR via RECIST v1.1 NSCLC 1.8 mg/kg Q2W, 2Q3W,
Slide 32: BA3011-002 NSQ NSCLC: Baseline Demographics and Characteristics
Phase 2 BA3011-002 NSQ NSCLC: Baseline Demographics and Characteristics BioAtla study enrolled a heavily pretreated 3L+ population BA3011 monotherapy BA3011 + nivolumab (N=23) (N=17) Total (N=40) Age, y, mean (SD) 68.3 (8.0) 68.9 (8.2) 68.6 (8.0) Number of prior systemic therapies, n (%) 1 4 (17.4)
Slide 33: BA3011 Non-Squamous NSCLC Response
Phase 2 BA3011 Non-Squamous NSCLC Prior PD-1/L1 treatment EGFR wild-type (N=15) Prior PD-1/L1 treatment (N=18) Data Cut Date: 30Jun23 Monotherapy 1.8 mg/kg Q2W shows encouraging efficacy signals Best Overall Response, n (%) Confirmed PR 3 (20.0) 3 (16.7) Unconfirmed PR 2 (13.3) 2 (11.1) SD 7 (46.7)
Slide 34: BA3011-002 NSCLC interim analysis
BA3011-002 NSCLC interim analysis BA3011 Monotherapy 1.8 mg/kg Q2W confirmed Rotow J, Dy GK, Camidge DR. Poster presented at: International Association for the Study of Lung Cancer 2023 North America Conference on Lung Cancer; December 1-3, 2023; Chicago, IL. BioAtla | Overview 34 Data Cut Date: 30J
Slide 35: BA3011-002 NSCLC interim analysis Monotherapy
BA3011-002 NSCLC interim analysis BA3011 Monotherapy 1.8 mg/kg Q2W PR SD PD Ongoing response AXL TmPS = 1% Patient featured in next slide Voluntary patient withdrawal Withdrawal due to AE Scan date Rotow J, Dy GK, Camidge DR. Poster presented at: International Association for the Study of Lung Cance
Slide 36: Radiographic response to BA3011 monotherapy
Radiographic response to BA3011 monotherapy 53 yo male with adenocarcinoma of the lung, September 20, 2023 March 6, 2023 – Baseline scan PDL1 <1%, TP53 mutation, 3 prior lines of tx (carbo/pem/pembro, docetaxel, durva/treme/selumetinib) Subcarinal mass Lymphangitic Pleural effusion carcinomatosis Su
Slide 37: Summary of Treatment Emergent Adverse Events (non-squamous NSCLC)
Summary of Treatment Emergent Adverse Events (non-squamous NSCLC) BA3011 BA3011 + Total monotherapy nivolumab (N=40) (n=23) (n=17) TEAEs with CTCAE grade 3 or 4 15 (65.2) 8 (47.1) 23 (57.5) Related grade 3 or 4 AEs 8 (34.8) 3 (17.6) 11 (27.5) Any serious TEAEs 9 (39.1) 5 (29.4) 14 (35.0) Related SAE
Slide 38: Treatment Emergent Adverse Events (Non-Squamous NSCLC)
Treatment Emergent Adverse Events (Non-Squamous NSCLC) * Any grade (≥15% of patients) OR grade ≥3 (≥3% of patients) in the study population Preferred term TEAEs of any grade, n (%) TEAEs of grade 3, n (%) Fatigue 14 (35.0) 1 (2.5) Diarrhea 10 (25.0) 1 (2.5) Constipation 9 (22.5) 0 Decreased appetite
Slide 39: BA3011 NSCLC Dose Optimization
Phase 2 BA3011 NSCLC Dose Optimization In-line with FDA Project Optimus • 2Q3W dosing regimen • 11 patients treated • 4 patients have been evaluable (3 SD and 1 PD) as of 12/4; target agnostic data expected in 1H 2024 • 3Q4W dosing regimen • Suboptimal compliance observed and enrollment has been dis
Slide 40: BA3011 NSCLC AXL Expression in Relation to Anti-tumor Activity
BA3011 NSCLC AXL Expression in Relation to Anti-tumor Activity Considerable anti-tumor activity among patients regardless of AXL expression level Best %Change in Sum of Target Lesions BA3011 Q2W Mono 40 30 20 10 0 -10 -20 -30 -40 -50 -60 0 10 20 30 40 50 60 70 80 90 100 TmPS (%) Anti-tumor activity
Slide 41: BA3011 NSCLC Randomized Registrational Study Design
BA3011 NSCLC Randomized Registrational Study Design Two Potentially Registrational Paths Enabled via the FDA Type C Meeting nd 2 Line + • Open-label; control: docetaxel • Patients with NSCLC who have been previously treated with at least one prior line of therapy for metastatic disease • Dual primar
Slide 42: CAB-ROR2-ADC Platform BA3021 Ozuriftamab Vedotin – NSCLC, Melanoma, SCCHN
CAB-ROR2-ADC Platform BA3021 Ozuriftamab Vedotin – NSCLC, Melanoma, SCCHN
Slide 43: Potential market opportunity in metastatic NSCLC
Potential market opportunity in metastatic NSCLC n ne ewly wly di dia ag gn no os se ed d p pa at tiie en nt ts s / / ye yea ar r p pe eo op plle e i in n t th he e Av Ava ai il la able ble T Tre rea at tm men ent t: : ~200K ( (U U.S .S. .) ) – – m ma aj jor ori ity ty >540K ~200K >540K U U.S .S. .
Slide 44: Encouraging results with BA3021 in refractory NSCLC
Encouraging Phase 1 results with BA3021 (Ozuriftamab Vedotin) in refractory patients with NSCLC Response at Variable Dosing 30% ROR2 + ROR2 – ROR2 + Not ROR2 + ROR2 + (**TmPS=100) (**TmPS=0) (**TmPS=45) Evaluable (**TmPS=95) (**TmPS=70) 1.2mg/kg d1,8 3mg/kg d1 3.3mg/kg d1 1.5mg/kg d1,8 3.3mg/kg d1 3
Slide 45: Potential market opportunity in metastatic melanoma
Potential market opportunity in metastatic melanoma Available Treatment newly diagnosed people in the 3 1L: ICIs 33% - 50% ORR ; (BRAF invasive cases / U.S. living with ~1.3MM ~100K 1 1 year (U.S.) / Mek inhibitors for BRAF+) melanoma 2L+: ICIs 9% - 28% ORR (mono – 4 combo, respectively) do not resp
Slide 46: BA3021 in stage IV multi-refractory melanoma
Phase 2 BA3021 in stage IV multi-refractory melanoma Promising early signals of efficacy - continuing to collect data in ongoing study • Completed enrollment Q2W targeted cohort who previously progressed on PD-1/L1 therapy • As of Nov 3, eight melanoma monotherapy patients are evaluable* with report
Slide 47: Potential market opportunity in SCCHN
Potential market opportunity in SCCHN people living Available Treatment newly diagnosed with head and 1L: Pembro, cetuximab, >400K ~66K 1 cases / year (U.S.) neck cancer 4 platinum 36% ORR 1 (U.S.) 4 2L+: ICIs 13% - 16% ORR with locally advanced disease limited effective develop recurrent 2L+ 3 ~50%
Slide 48: Results with BA3021 support advancing into Phase 2 in multiple indications
Phase 1 results with BA3021 support advancing into Phase 2 in multiple indications ROR2+ Tumor Types Results NSCLC§ PR in 2 / 3 patients who previously experienced failure on PD-1 and who received Phase 2 dose or higher Melanoma§ CR in 1 / 1 patient who previously experienced failure on PD-1 § Clear
Slide 49: Dosing regimens under evaluation for CAB-ROR2-ADC BA3021
Dosing regimens under evaluation for CAB-ROR2-ADC BA3021 Ozuriftamab Vedotin Dose Day1 Day 8 Day 15 Day 22 Q2W All cycles (28 days) 1.8 mg/kg no drug 1.8 mg/kg no drug 2Q3W 1.8 mg/kg 1.8 mg/kg no drug ― All cycles (21 days) 3Q4W 2.0 mg/kg 1.3 mg/kg 1.3 mg/kg ― Cycle 1 (21 days) 1.3 mg/kg 1.3 mg/kg 1
Slide 50: Summary of Dosing Regimens for Phase 2 Clinical Studies with BA3021
Summary of Dosing Regimens for Phase 2 Clinical Studies with CAB-ROR2-ADC BA3021 Ozuriftamab Vedotin Indication Dose Maximum Patient # Status Q2W monotherapy N ~ 20 √ NSCLC* Q2W in combo w/ nivolumab N ~ 20 √ Not advancing; 3Q4W monotherapy N ~ 20 suboptimal compliance Q2W monotherapy N ~ 25 Fully e
Slide 51: Bispecific Platform CAB-EpCAM x CAB-CD3 (BA3182) – Adenocarcinoma
Bispecific Platform CAB-EpCAM x CAB-CD3 (BA3182) – Adenocarcinoma
Slide 52: BA3182 CAB-EpCAMxCAB-CD3 bispecific T-Cell Engager
BA3182 – CAB-EpCAMxCAB-CD3 bispecific T-Cell Engager (TCE) significant opportunity for safe and effective EpCAMxCD3 bispecific • BA3182 exhibits efficient tumor • EpCAM expressed on normal epithelial shrinkage with superior safety profile cells and overexpressed in a wide range • In non-GLP and GLP
Slide 53: FDA cleared IND for BA3182 Phase 1/2 trial design
FDA cleared IND for CAB-EpCAMxCAB-CD3 bispecific TCE (BA3182) Phase 1/2 trial design in advanced adenocarcinoma Part 1: Up to 128 patients with advanced adenocarcinoma • Up to 8 patients in the accelerated titration • Up to 60 in each of the 2-treatment schedules for 10 planned standard titration do
Slide 54: Key milestones and catalysts throughout 2024
Key milestones and catalysts throughout 2024 2024 1H 2H • BA3071: • BA3071: o Readout additional Phase 2 data in treatment-refractory solid tumors o Evaluate safety and efficacy of BA3071 at 10mg/kg and potentially, 14.2mg/kg dose levels o Define pivotal path for BA3071 in treatment-refractory indic
Slide 55: BioAtla Overview
© BioAtla is a clinical stage company focused on transforming cancer therapy with Conditionally Active Biologics (CABs) Two Phase 2 CAB-ADCs, Prioritized pipeline one Phase 2 CAB-CTLA-4 Proprietary technology $141.3 million in cash and Clinical readouts for and one Phase 1 dual CAB- cash equivalents