ozuriftamab vedotin (BA3021) / BioAtla - LARVOL DELTA

Key Developments, Operational Updates and Upcoming Milestones (GlobeNewswire) - "Continue preparations for initiation of the Oz-V Phase 3 study in 2L+ OPSCC; on track to advance with a strategic partner in early 2026."

New P3 trial • Oropharyngeal Cancer • Squamous Cell Carcinoma

TARGETING HPV E6/E7 UPREGULATION OF THE TRANSMEMBRANE RECEPTOR TYROSINE KINASE ROR2 WITH THE ADC OZURIFTAMAB VEDOTIN IN PATIENTS WITH ADVANCED HPV+ OROPHARYNGEAL SQUAMOUS CELL CARCINOMA (IPVC 2025) - "Oz-V, an ADC targeting the ROR2 cell surface antigen that is overexpressed in HPV+ cancers achieved promising anti-tumor activity among patients with heavily pretreated HPV+ OPSCC. Oz-V was well-tolerated, toxicity was readily manageable, and a prospective Phase 3 study for advanced HPV+ OPSCC is actively planned. Use of an ADC to selectively ablate ROR2-expressing cells represents an important new, first-in-class therapeutic modality for patients with HPV+ cancers POSTERS ON BOARDS ABSTRACTS"

Clinical • Late-breaking abstract • Metastases • Anemia • Fatigue • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ROR2

Identification of novel ROR2 interaction partners required for its pro-migratory signalling in breast cancer (DGHO 2025) - "Functional studies included treatment with the monoclonal ROR2 antibody Ozuriftamab and/or its antibody-drug conjugate Ozuriftamab-Vedotin... This study identifies ROR2 as a novel tumor antigen overexpressed in TNBC. Its restricted expression in normal tissue and its functional role in regulating tumor cell migration highlight its potential as a therapeutic target-particularly for delivering cytotoxic agents and inhibiting tumor dissemination in aggressive BC subtypes such as TNBC."

Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ANXA3 • LAD1 • LMNB1 • ROR2

BA3021-002: A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) - P2 | N=42 | Completed | Sponsor: BioAtla, Inc. | N=290 ➔ 42 | Trial completion date: Dec 2026 ➔ Sep 2025 | Trial primary completion date: Dec 2026 ➔ Sep 2025 | Recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

BioAtla Presents Compelling Mechanistic Rationale for Targeting ROR2 with Ozuriftamab Vedotin (Oz-V) in Oropharyngeal Squamous Cell Carcinoma (OPSCC) at the Annual Conference of the International Papillomavirus Society (GlobeNewswire) - "The poster will provide a deeper molecular review of Oz-V, CAB-ROR2-ADC, a more detailed mechanistic discussion regarding the relationship between ROR2 expression and HPV infection and will highlight clinical data previously presented at medical congresses."

Clinical data • Oropharyngeal Cancer • Squamous Cell Carcinoma

CRI-CCTG-0003/IND.240: Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Platinum resistant • Trial completion date • Trial primary completion date • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

BioAtla Announces Regulatory Update on Clinical Development Plan for Ozuriftamab Vedotin in Oropharyngeal Squamous Cell Carcinoma (OPSCC) Following Productive Type B (End of Phase 2) Meeting with FDA (GlobeNewswire) - "Company continues preparations for enabling initiation of the Phase 3 study with the goal of advancing the study with a strategic partner early next year...Outcomes from the FDA Type B Meeting: Pivotal Trial Design: For full approval, approximately 300 OPSCC patients prospectively randomized and stratified, one to one between two open label treatment arms...Patients randomized to the investigational arm will receive 1.8 mg/kg every other week; Investigator’s Choice (IC) control arm: Patients randomized to the control arm will receive either cetuximab, docetaxel, or methotrexate monotherapy....Full Approval Endpoint: Statistically significant improvement of OS."

FDA event • New P3 trial • Oropharyngeal Cancer • Squamous Cell Carcinoma

BioAtla Reports Second Quarter 2025 Financial Results and Highlights Recent Progress (BioAtla Press Release) - "Phase 1/2 dose-escalation for conditionally binding BA3182 (CAB-EpCAM x CAB-CD3 TCE) (NCT05808634) in heavily pretreated patients with unresectable or metastatic adenocarcinoma: Phase 1 dose-escalation ongoing and on track for data readout 2H 2025....Cohort expansion data readout anticipated 1H 2026. ozuriftamab vedotin (Oz-V): Planned meeting with the FDA for guidance on proposed Phase 3 study in treatment-refractory, metastatic HPV+ OPSCC in 3Q 2025."

P1 data • Oncology

First report of ROR2 directed therapy with a conditionally active antibody drug conjugate in advanced melanoma. (ASCO 2025) - P1/2 | "Ozuriftamab vedotin showed early promising antitumor activity in this first report describing ROR2 directed treatment in refractory advanced cutaneous and uveal melanoma. Efficacy and Safety of Ozuriftamab Vedotin.*Patient has not developed progressive disease since starting treatment."

Metastases • Eye Cancer • Melanoma • Neutropenia • Oncology • Pain • Solid Tumor • Uveal Melanoma • ROR2

Phase 2 trial of ozuriftamab vedotin (BA3021), a conditionally binding ROR2-ADC, in patients with heavily pretreated squamous cell carcinoma of the head and neck. (ASCO 2025) - P1/2 | "Pts treated with ozuriftamab vedotin achieved a high rate of disease control with acceptable tolerability. Shows promising efficacy, including in pts refractory to anti-PD1 and warrants further evaluation in SCCHN."

Clinical • IO biomarker • P2 data • Anemia • Cardiovascular • Fatigue • Head and Neck Cancer • Heart Failure • Hematological Disorders • Oncology • Pain • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ROR2

BioAtla Presents Phase 2 Ozuriftamab Vedotin (Oz-V) Clinical Trial Data Demonstrating Compelling Antitumor Activity in HPV-Associated Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) at the 1.8 mg/kg Q2W dosing regimen (The Manila Times) - P1/2 | N=132 | NCT03504488 | Sponsor: BioAtla, Inc. | "Plan to finalize Phase 3 trial design in 2L+ HPV+ OPSCC with the U.S. Food and Drug Administration...The poster will be presented today at the 2025 American Society of Clinical Oncology...In the Phase 2 clinical trial, patients with heavily pretreated squamous cell carcinoma of the head and neck (SCCHN) received 1.8 mg/kg of Oz-V given in two schedules....For the efficacy analysis, 22 pts had HPV+ OPSCC (as of May 14, 2025); safety data presented (as of April 13, 2025) were based on the full dataset (n=40); In HPV+ OPSCC pts, Oz-V demonstrated compelling antitumor activity in patients receiving 1.8 mg/kg Q2W: ORR 45% (5/11), 27% (3/11) confirmed, DCR 100% (11/11), continuing follow-up; Median duration of response 9.9 months, median progression-free survival 4.7 months, and median overall survival 11.6 months and ongoing."

New P3 trial • P2 data • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

BioAtla Reports First Quarter 2025 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Research and development (R&D) expenses were $12.4 million for the quarter ended March 31, 2025 compared to $18.9 million for the same quarter in 2024. The decrease of $6.5 million was primarily due to lower clinical development expenses in 2025 for our Phase 2 trials for mecbotamab vedotin, ozuriftamab vedotin and evalstotug as we complete trials for certain indications."

Commercial • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

BioAtla Announces Upcoming Poster Presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "BioAtla...announced a poster presentation at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting....Title: Phase 2 trial of ozuriftamab vedotin (BA3021), a conditionally binding ROR2-ADC, in patients with heavily pretreated squamous cell carcinoma of the head and neck; Abstract Number: 6048."

P2 data • Squamous Cell Carcinoma of Head and Neck

Preclinical development of ozuriftamab vedotin (BA3021), a novel ROR2-specific conditionally active biologic antibody-drug conjugate. (PubMed, MAbs) - "In non-human primates, BA3021 was well tolerated at doses of up to 10 mg/kg and showed excellent stability in vivo. These preclinical results indicate that CAB anti-ROR2 ADC is efficacious and well tolerated and may be a promising treatment for cancer patients with ROR2-expressing tumors."

Journal • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Genito-urinary Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Osteosarcoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Sarcoma • Solid Tumor • ROR2

Phase 2 Trial of ozuriftamab vedotin (Oz-V), CAB-ROR2-ADC (NCT05271604) in treatment-refractory SCCHN (median of 3 prior lines of treatment) (GlobeNewswire) - P2 | N=290 | NCT05271604 | Sponsor: BioAtla, Inc. | "Oz-V monotherapy continues to deliver responses among patients with 2L+ SCCHN at the 1.8 mg/kg Q2W dosing regimen; ORR, DOR, PFS, and OS data capture ongoing. Updated data presented at the Mayo Multidisciplinary Head and Neck Cancer Symposium on March 27, 2025....Differentiated anti-tumor activity observed particularly in treatment-refractory and metastatic HPV-positive SCCHN, which is poorly served by EGFR inhibitors (n=11). 45% ORR (confirmed and unconfirmed); 27% confirmed so far with a DOR >5.3 months with multiple patients remaining on treatment. 100% disease control. The one patient who achieved a CR continues in complete remission, now at greater than 16 months ongoing. Oz-V continues to be well-tolerated, consistent with previous reports."

P2 data • Squamous Cell Carcinoma of Head and Neck

BioAtla Announces Two Poster Presentations at Upcoming Medical Meetings (GlobeNewswire) - "BioAtla...announced two abstracts accepted for poster presentations at the upcoming European Lung Cancer Congress (ELCC) 2025 Scientific Committee and Mayo Clinic Multidisciplinary Head and Neck Cancer Symposium 2025, to be held in Paris, France from March 26–29, 2025 and in Scottsdale, AZ from March 27–29, 2025, respectively....Venue: ELCC 2025; Title: Exploratory Analysis of Overall Survival among Non-Small Cell Lung Cancer (NSCLC) Patients with Mutated KRAS in a Phase 2 Trial of Mecbotamab Vedotin (CAB-AXL-ADC)....Venue: Mayo Clinic Multidisciplinary Head and Neck Cancer Symposium 2025; Title: Ozuriftamab Vedotin (BA3021), a Conditionally Binding ROR2-ADC; Phase 2 experience in Patients with Heavily Pretreated Squamous Cell Carcinoma of the Head and Neck."

P2 data • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

CRI-CCTG-0003/IND.240: Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

BA3021-001: CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2) (clinicaltrials.gov) - P1/2 | N=132 | Completed | Sponsor: BioAtla, Inc. | Active, not recruiting ➔ Completed | N=420 ➔ 132

Enrollment change • Trial completion • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

BA3021-001: CAB-ROR2-ADC Safety and Efficacy Study in Patients with TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2) (clinicaltrials.gov) - P1/2 | N=420 | Active, not recruiting | Sponsor: BioAtla, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Dec 2024 | Trial primary completion date: Dec 2025 ➔ Dec 2024

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

CRI-CCTG-0003/IND240 AN IMMUNOTHERAPY PLATFORM STUDY (IPROC) IN PLATINUM-RESISTANT HIGH GRADE SEROUS OVARIAN CANCER (PLTNR-HGSC): SUBSTUDIES A/B: DURVALUMAB + BA3011 OR BA3021.(NCT04918186) (IGCS 2024) - P2 | "Pts screened/AXL+/ROR2+ were 62/19/41. 20 pts, 10/sub-study, were treated. Sub-study A: Best response was SD (N=7/10pts) median duration and range (MD/R) 3.6 mo/2.4 – 3.7."

High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • AXL • ROR2

BA3021-002: A Phase 2 Open Label Study of BA3021 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) - P2 | N=290 | Recruiting | Sponsor: BioAtla, Inc. | N=80 ➔ 290 | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Phase II trial of ozuriftamab vedotin (BA3021), a conditionally active biologic (CAB)-ROR2-ADC, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) (ESMO 2024) - P2 | "Treatment with BA3021 yielded promising antitumor activity with a manageable tolerability profile in heavily pretreated pts (median 3 prior regimens) with R/M SCCHN. Further evaluation of BA3021 in earlier-stage pts is planned."

Clinical • Metastases • P2 data • Head and Neck Cancer • Melanoma • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ROR2

BioAtla Presented Phase 2 Ozuriftamab Vedotin Clinical Trial Data Demonstrating Meaningful Antitumor Activity with Manageable Tolerability among Heavily Pretreated Patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting (GlobeNewswire) - P2 | N=80 | NCT05271604 | Sponsor: BioAtla, Inc. | "An ongoing complete response (CR) with an overall response rate (ORR) of 32% achieved across two dosing regimens; Underscores ozuriftamab vedotin’s activity in a high unmet need SCCHN patient population; The conditionally binding ADC targeting ROR2 was notably well tolerated; The Company intends to meet with the FDA to discuss a SCCHN potential registrational trial in 2H 2024."

New trial • P2 data • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

868P - Phase II trial of ozuriftamab vedotin (BA3021), a conditionally active biologic (CAB)-ROR2-ADC, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) (ESMO 2024) - P2 | N=80 | NCT05271604 | Sponsor: BioAtla, Inc. | "As of March 13, 2024, 31 pts with a median of 3 prior lines of therapy received BA3021 either Q2W (n=12) or 2Q3W (n=19) for a median of 58 days. Overall, among 25 pts evaluable for efficacy, 8 responders (32%; 1 CR and 7 PR; confirmed and unconfirmed) were reported, and 10 pts had SD. In the Q2W cohort (12 evaluable pts), 1 CR, 2 PR, and 4 SD were reported. In the 2Q3W cohort (13 evaluable pts), 5 PR and 6 SD were reported. The most frequent TEAEs were fatigue (55%), nausea (29%), anemia (26%), decreased appetite (26%), and diarrhea (26%). Nineteen pts had grade 3‒4 TEAEs; the most frequent (10% each) were anemia, hyponatremia, and hypoxia. Related grade 3 peripheral neuropathy led to study drug discontinuation in 1 pt. As of the data cut, 11 pts remained on BA3021 (2 in Q2W and 9 in 2Q3W)."

P2 data • Squamous Cell Carcinoma of Head and Neck

BioAtla Announces Upcoming Poster Presentation at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting (GlobeNewswire) - "BioAtla, Inc...announced a poster presentation at the upcoming 2024 European Society for Medical Oncology (ESMO) Annual Meeting to be held in Barcelona, Spain from September 13–17, 2024."

P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck