BioAtla, Inc. (NASDAQ:BCAB) is a clinical-stage biopharmaceutical company at the forefront of developing a novel class of highly specific and selective antibody-based therapeutics for the treatment of solid tumor cancers. The company's proprietary Conditionally Active Biologics (CABs) platform has enabled the creation of a pipeline of product candidates that capitalize on characteristic pH differences between the tumor microenvironment and healthy tissue.

Business Overview

BioAtla was founded in 2007 and is headquartered in San Diego, California. The company's primary focus is on advancing its CAB technology platform to develop antibody-drug conjugates (ADCs) and other biologics that can selectively bind to and become activated in the acidic tumor microenvironment, while remaining inert in healthy tissues. This approach aims to enhance the therapeutic window and improve the safety profile of these treatments compared to traditional antibody-based therapies.

BioAtla's lead CAB ADC product candidates include mecbotamab vedotin (BA3011), targeting AXL, and ozuriftamab vedotin (BA3021), targeting ROR2. The company is also developing a CAB anti-CTLA-4 antibody, evalstotug (BA3071), and a CAB bispecific antibody, BA3182, targeting EpCAM and CD3. These programs are currently in various stages of clinical development, with several key data readouts and regulatory milestones anticipated in the coming year.

Financials

For the full year 2023, BioAtla reported a net loss of $123.5 million and no revenue, as the company continues to focus on the development of its pipeline. The company's annual operating cash flow was -$104.0 million, and its annual free cash flow was -$104.1 million. These financial results reflect the significant investments BioAtla is making in its research and development efforts to advance its CAB technology and product candidates.

In the first quarter of 2024, BioAtla reported a net loss of $23.2 million, compared to a net loss of $27.4 million in the same period of the prior year. Research and development expenses for the quarter were $18.9 million, down from $21.7 million in the first quarter of 2023, primarily due to the completion of preclinical development related to the company's Nectin-4 program and the prioritization of its clinical programs. General and administrative expenses also decreased to $5.6 million from $7.2 million in the prior-year quarter, driven by lower stock-based compensation and professional fees.

Liquidity

As of March 31, 2024, BioAtla had $80.6 million in cash and cash equivalents, compared to $111.5 million as of December 31, 2023. The company expects its current cash and cash equivalents to fund operations into the second half of 2025, with quarterly cash burn expected to decrease in the second half of 2024 as the company completes patient treatments in its ADC clinical trials.

Pipeline Progress and Upcoming Milestones

BioAtla has made significant progress across its pipeline of CAB-based product candidates, with several key updates and upcoming milestones:

CAB-ROR2-ADC (ozuriftamab vedotin) in Head and Neck Cancer

In the company's ongoing Phase 2 trial in heavily pre-treated head and neck cancer patients, BioAtla has reported encouraging data, with 38% of patients achieving a response and an 86% disease control rate. The company plans to meet with the FDA in the second half of 2024 to discuss a potentially registrational trial for this program.

CAB-CTLA-4 (evalstotug) in Melanoma

BioAtla's CAB-CTLA-4 antibody, evalstotug, has demonstrated a favorable safety profile in its ongoing Phase 1/2 trial, with few immune-related adverse events observed, even at high dose levels. The company is now designing an efficient, blinded, randomized, pivotal trial evaluating evalstotug in combination with pembrolizumab for newly diagnosed patients with BRAF-mutated metastatic or unresectable melanoma, and plans to seek FDA feedback on this trial design in the second half of 2024.

CAB-AXL-ADC (mecbotamab vedotin) in Sarcoma

BioAtla has completed dosing patients in the first portion of a potentially registrational trial evaluating its CAB-AXL-ADC, mecbotamab vedotin, in undifferentiated pleomorphic sarcoma. The company remains on track to evaluate the clinical benefit of this ADC in a target-agnostic cancer patient population later in 2024.

CAB Bispecific T-Cell Engager (BA3182)

BioAtla's first-in-class, dual CAB bispecific T-cell engager, BA3182, targeting EpCAM and CD3, is progressing through a Phase 1 dose escalation trial, with data expected in the second half of 2024. The company plans to initiate a Phase 2 study for this program later this year.

Risks and Challenges

As a clinical-stage biopharmaceutical company, BioAtla faces several risks and challenges common to the industry, including the inherent uncertainty of drug development, the potential for clinical trial failures or delays, regulatory approval hurdles, and competition from other novel cancer therapies. The company's reliance on its CAB technology platform also introduces the risk of potential setbacks or limitations in the broader applicability of this approach.

Additionally, BioAtla's financial position, with no revenue and significant ongoing research and development expenses, reflects the capital-intensive nature of its business model. The company will need to continue accessing the capital markets to fund its operations and pipeline advancement, which could result in dilution for existing shareholders.

Outlook

BioAtla has made impressive strides in advancing its pipeline of CAB-based product candidates, with several programs poised to reach key milestones in the coming year. The company's focus on selectively targeting the tumor microenvironment with its novel CAB technology holds the promise of improving the therapeutic index and safety profile of its therapies compared to traditional antibody-based approaches.

Conclusion

With multiple data readouts and potential regulatory interactions on the horizon, BioAtla is well-positioned to continue its momentum and potentially establish new standards of care for patients with solid tumor cancers. As the company navigates the challenges inherent to drug development, its innovative platform and promising clinical results warrant close attention from investors in the biotechnology space.