CAB-CTLA-4 (BA3071) Phase 1 study cleared dose-limiting toxicity (DLT) observation period with 700 mg (10 mg/kg); initial Phase 2 monotherapy data readout anticipated in 2Q 2024 and in combination with pembrolizumab in 2H 2024
CAB-ROR2 (BA3021) Phase 2 melanoma and squamous cell carcinoma of the head and neck (SCCHN) clinical trials fully enrolled; on track for data readouts in 2Q 2024
CAB-AXL (BA3011) Phase 2 potentially registrational study in undifferentiated pleomorphic sarcoma (UPS) on track for enrollment completion of approximately 20 patients in April with anticipated FDA meeting for guidance on the remaining portion of the potentially registrational trial in 2H 2024
CAB-EpCAM x CAB-CD3 (BA3182) Phase 1 dose-escalation study on track with full data readout anticipated in 2H 2024; potential initiation of Phase 2 study in 2H 2024
Cash balance of $111.5 million at year-end 2023 is expected to fund operations into 2H 2025
Management to host conference call and webcast today at 4:30 PM Eastern Time
SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) — BioAtla, Inc. (NASDAQ:BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced its financial results for the fourth quarter and full year ended December 31, 2023, and provided highlights on its clinical programs.
“BioAtla continued to make considerable progress in 2023 across both of our CAB-ADC clinical trials targeting multiple tumor types, as well as advancing our CAB-CTLA-4 clinical asset, BA3071, with recent clearance of the DLT observation period at the 10 mg/kg dosing cohort,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “We are excited to have several upcoming important milestones in the second quarter of this year including: initial data readouts from our Phase 2 BA3071 study; Phase 2 data for CAB-ROR2-ADC, BA3021, in both melanoma and head and neck cancer; and evaluation of clinical benefit in AXL-agnostic patients in our CAB-AXL-ADC, BA3011, Phase 2 NSCLC extension study. As we finalize these data sets in preparation for potentially registrational trials across our lead programs, we are engaging with potential pharmaceutical partners that are capable of accelerating development and maximizing the value of selected assets.”
Key Developments, Operational Updates and Upcoming Milestones
Phase 1/2 dose-escalation trial of Evalstotug, CAB-CTLA-4 (BA3071, NCT05180799) across multiple solid tumor types responsive to CTLA-4
Phase 1 study
Cleared DLT observation period at 700 mg (10 mg/kg for 70 kg person)
Enrolling dose cohort of 1000 mg (14.2 mg/kg for 70 kg person); on track to clear DLT period in 2Q 2024
Initial Phase 2 data readout in approximately 20 patients with two scans in treatment-refractory solid tumors at 350 mg or 700 mg (5 or 10 mg/kg for 70 kg person) treated with monotherapy anticipated in 2Q 2024
Currently enrolling first-line melanoma and NSCLC patients at the 350 mg or 700 mg (5 or 10 mg/kg for 70 kg person); anticipated data readout of BA3071 combination with pembrolizumab in 2H 2024
Phase 2 Trials of Ozuriftamab Vedotin, CAB-ROR2-ADC, (BA3021) in treatment-refractory melanoma (NCT03504488) and treatment-refractory SCCHN (NCT05271604)
Melanoma patients (n=28) dosed at the Q2W regimen; anticipate two plus scans in April
SCCHN patients dosed at Q2W or 2Q3W regimens (n=12 and 20, respectively); anticipate two plus scans in May
Data readouts for both indications anticipated in May
Phase 2 Trials of Mecbotamab Vedotin, CAB-AXL-ADC, (BA3011):
UPS (NCT03425279) ongoing potentially registrational trial
On track to complete enrollment of approximately 20 patients in April
Anticipate FDA meeting for guidance on the remaining portion of the registration trial in 2H 2024
Bone and soft tissue sarcomas (NCT03425279)
Data presented as oral presentation at ESMO Sarcoma and Rare Cancers on March 14
Promising monotherapy disease control rate among 43% of patients with treatment-refractory sarcomas (n=87)
Osteosarcoma: two partial responses observed out of 11 efficacy-evaluable patients with observed PFS at 12 weeks of 45.5%
Manageable safety profile with no new safety signals reported, no Grade 3 peripheral neuropathy
NSCLC (NCT04681131)
Enrolled 33 target-agnostic patients at the 2Q3W regimen across squamous and non-squamous patients
Study is on track to evaluate initial clinical benefit in the target-agnostic non-squamous EGFR wild-type patient population in 2Q 2024
Phase 1/2 dose-escalation for CAB-EpCAM x CAB-CD3 TCE (BA3182, NCT05808634)
Anticipate completion of Phase 1 with data readout in 2H 2024
Potential initiation of Phase 2 study in 2H 2024
Anti-Nectin-4-ADC (BA3361)
In vitro and in vivo characterization of a novel NextGen linker system yields differentiated anti-Nectin-4-ADC
Data to be presented at upcoming AACR Annual Meeting in April:
Complete tumor regression observed in several cell line derived xenograft models
Superior efficacy to an enfortumab vedotin analogue in a patient-derived xenograft pancreatic cancer model
Demonstrated influence of linker technology on specific cancer models and reduced toxicity through CAB selectivity
IND submission anticipated in 2Q 2024
Presentations
Oral presentation titled “Results from a Phase 2 part 1 trial of mecbotamab vedotin (BA3011), a CAB-AXL-ADC, in patients with advanced refractory sarcoma” at ESMO Sarcoma and Rare Cancers Congress March 2024
Trial in Progress poster titled “Phase 1 study of BA3182, a conditionally active bispecific anti-EpCAM x CD3 antibody, in patients with advanced adenocarcinoma” presented at SITC Spring Scientific Meeting March 2024
Five preclinical abstracts accepted for poster presentations at the upcoming American Association for Cancer Research (AACR) 2024 Annual Meeting, titled:
“Using a novel NextGen linker system to generate a Conditionally Active Biologic (CAB) anti-Nectin4-ADC demonstrates improved efficacy in pancreatic PDX cancer models and improved tolerability and toxicity profile in non-human primates”
“Novel conditionally active tetravalent B7-H3 x CD3 T-cell engager targeting solid tumors”
“Novel Conditionally Active Biologic (CAB) tetravalent T-cell engagers targeting solid tumors”
“Targeting novel senescence markers by Conditionally Active Biologics eliminates senescence-associated secretory phenotype in in vitro and in vivo models”
“Development of a humanized anti-IL-22 antibody for cancer and inflammation therapy”
Late-breaking abstract titled “Novel Conditionally Active Biologic (CAB) tetravalent T-cell engagers targeting solid tumors” accepted for presentation at the upcoming AACR Annual Meeting April 2024 and will be published online in Proceedings of the AACR
Online article published in mABs March 2024 (https://doi.org/10.1080/19420862.2024.2322562), titled “A novel Conditional Active Biologic anti-EpCAM x anti-CD3 bispecific antibody with synergistic tumor selectivity for cancer immunotherapy”
Fourth Quarter and Full Year 2023 Financial Results
Research and development (R&D) expenses were $22.7 million for the quarter ended December 31, 2023 compared to $21.9 million for the same quarter in 2022. The increase of $0.8 million was due to clinical development expenses primarily related to the launch of our BA3011 UPS potentially registrational trial in 2023 and overall accelerated enrollment across our clinical trials in 2023, offset by a decrease in expense for our pre-clinical programs and selected clinical indications due to our program prioritization in 2023. We expect our R&D expenses to decrease overall in the 1H of 2024 due to recent completion of enrollment in clinical trials for data sets expected to enable potentially registrational trials for our ADC programs, BA3021 and BA3011.
General and administrative (G&A) expenses were $5.9 million for the quarter ended December 31, 2023 compared to $6.7 million for the same quarter in 2022. The $0.8 million decrease was primarily due to lower stock based compensation and D&O insurance premiums.
Net loss for the quarter ended December 31, 2023 was $26.9 million compared to a net loss of $27.6 million for the same quarter in 2022.
Net cash used in operating activities for the full year ended December 31, 2023 was $104.0 million compared to net cash used in operating activities of $90.4 million for the same period in 2022. Cash used for the quarter ended December 31, 2023 was $29.8 million.
Cash and cash equivalents as of December 31, 2023 were $111.5 million, compared to $215.5 million as of December 31, 2022. We expect our current cash and cash equivalents will be sufficient to fund operations into the second half of 2025.
Fourth Quarter and Full Year 2023 Conference Call and Webcast Details
The management of BioAtla, Inc. will host a conference call and webcast for the investment community today, March 26, 2024, at 4:30 pm Eastern Time. A live webcast may be accessed here:
https://viavid.webcasts.com/starthere.jsp?ei=1653291&tp_key=ca14db6fd2. The conference call can be accessed by dialing toll-free (877) 425-9470 or (201) 389-0878 (international). The passcode for the conference call is 13744024.
A replay of the webcast and slides with topline interim clinical data referenced on the call will be available through “Events & Presentations” in the Investors section of the company’s website after the conclusion of the presentation and will be archived on the BioAtla website for one year.
About Mecbotamab Vedotin (BA3011)
Mecbotamab vedotin, CAB-AXL-ADC, is a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL. This Phase 2 stage clinical asset is targeting multiple solid tumor indications, including the treatment of soft tissue and bone sarcoma and non-small cell lung cancer (NSCLC) patients who have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapies. The Office of Orphan Products Development (OOPD) at FDA granted Orphan Drug Designation to mecbotamab vedotin for the treatment of soft tissue sarcoma.
About Ozuriftamab Vedotin (BA3021)
Ozuriftamab vedotin, CAB-ROR2-ADC, is a conditionally …