Yahoo Finance BioAtla, Inc. (NASDAQ:BCAB) Q3 2023 Earnings Call Transcript
BioAtla, Inc. (NASDAQ:BCAB) Q3 2023 Earnings Call Transcript November 12, 2023
Operator: Good afternoon, ladies and gentlemen, and welcome to the BioAtla Third Quarter 2023 Earnings Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] Please be advised that this call is being recorded on Tuesday, November 7, 2023. I would now like to turn the conference over to Bruce Waldron of LifeSci Advisors. Please go ahead.
Bruce Mackle: Thank you, operator, and good afternoon, everyone. With me today on the phone from BioAtla are Dr. Jay Short, Chairman, CEO and Co-Founder; and Rick Waldron, Chief Financial Officer. Following today's call, Dr. Eric Sievers, Chief Medical Officer; and Sheri Lydick, Chief Commercial Officer, will join Jay and Rick for a short Q&A. Earlier this afternoon, BioAtla released financial results and a business update for the third quarter ended September 30th, 2023. A copy of the press release and corporate presentation are available on the company's website. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements, including, but not limited to, statements regarding BioAtla's business plans and prospects and whether it's clinical trials will support registration, plans to form collaborations and other strategic partnerships for selected assets; results, conduct, progress and timing of its research and development programs in clinical trials; expectations with respect to enrollment and dosing in its clinical trials, plans and expectations regarding future data updates, clinical trials, regulatory meetings and regulatory submissions.
The potential regulatory approval path for its product candidates; expectations about the sufficiency of its cash and cash equivalents, plans to prioritize and focus development on selected assets and indications and expected R&D and G&A expenses. These statements are subject to various risks, assumptions and uncertainties that can cause actual results to differ materially and are described in the filings made with the SEC, including the most recent quarterly report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, November 7, 2023, and BioAtla disclaims any obligation to update such statements to reflect future information, events or circumstances, except as required by law.
With that, I'd like to turn the call over to Jay Short. Jay?
Jay Short: Thank you, Bruce, and thanks to everyone for joining us for our third quarter 2023 BioAtla earnings call. BioAtla is the inventor and leader in the development of novel therapies using a proprietary conditionally active biologics CABS platform with improved selectivity for attacking tumor cells while avoiding healthy cells, thereby addressing critical unmet needs in oncology to improve patients' lives. As we approach the end of 2023, we have obtained data to support several value inflection points across our CAB portfolio and continue to focus on further advancing the development of our prioritized CAB programs. We believe that forming one or more strategic collaborations with major pharmaceutical partners can accelerate development of selected assets and maximize their market opportunities.
We also believe that our more focused and strategic approach better positions us to enhance value for shareholders. Additional details related to what I'm going to provide are available in today's press release and our revised company presentation, both of which are available on our website. I will now provide some new updates since our second quarter call in August, beginning with our CAB-AXL-ADC, BA3011. Regarding our BA3011 Phase II study in non-small cell lung cancer, we have consistently observed multiple clinical responses in AXL-positive treatment refractory lung cancer populations. Among patients receiving BA3011 monotherapy who previously experienced PD-1 treatment failure and were evaluable for efficacy at 12 weeks. The observed objective response rate was 27.8%.
In patients with EGFR wild-type, non-squamous lung cancer who previously experienced PD-1 treatment failure, 33.3% of the patients had a partial response to BA3011 monotherapy. Of note, AXL expression in lung cancer defines a particularly poor prognostic group. Also, these patients had experienced the failure of a median of three prior lines of therapy. So we believe that observing multiple responses in this treatment refractory poor prognostic group is clinically meaningful and relevant. In addition to the consistent differentiated safety profile, we continue to observe clinical benefit in patients, including multiple PRs at a TmPS score of 1%. We are exploring the potential clinical benefits in AXL TmPS negative patients, which is important for understanding the market potential of BA3011 in lung cancer.
Earlier this quarter, we also received verbal FDA feedback that we believe is supportive of a registrational path forward for BA3011 in lung cancer. We anticipate receiving formal written feedback later this month and plan to share more details and interim Phase II data to be presented at the IASLC conference and our KOL event in early December. Our Phase II potentially registrational study for Undifferentiated Pleomorphic Sarcoma, or UPS is ongoing, and we continue to enroll the 2Q3W dosing regimen for up to 20 patients. We have decided not to further advance the 3Q4W dosing regimen across any cohorts in either the BA3011 or the BA3021 studies due to suboptimal compliance with this dosing regimen, which is consistent with the lack of meaningful difference in efficacy observed with BA3011 and leiomyosarcoma.
In regards to other bone and soft tissue sarcoma cohorts, we are pleased to have yet our internal Go criteria for several sarcoma subtypes, including synovial sarcoma, liposarcoma and osteosarcoma. As a reminder, our internal Go criteria is defined as achieving greater than or equal to one complete response/partial response or a progression-free survival rate of greater than or equal to 40% at 12 weeks. All cohorts are now completed, and we plan to submit available data to a medical meeting in 2024. As previously communicated, our highest priority is to deliver innovative life-changing therapies to cancer patients with significant unmet medical needs. We have now observed multiple clinical responses in several treatment-refractory solid tumor populations with our CAB-AXL-ADC asset, BA3011.
We have also recently received feedback from the FDA on the BA3011 lung cancer registrational study design. Taken together, we continue to believe that BA3011 is an active agent in treatment-refractory tumors and has the potential to become a first-in-class treatment for a significant number of patients who experienced the failure of at least one prior line of therapy. Now turning to our second CAB-ADC asset, BA3021, a CAB-ROR2-ADC. For our ongoing Phase II trials, we have completed enrollment of approximately 20 patients at the Q2W dosing regimen in both lung cancer and melanoma and anticipate to complete enrollment of up to 20 patients at the 2Q3W dosing regimen in head and neck cancer before year-end. In treatment-refractory patient populations, there are encouraging early responses in the Phase II melanoma study at the Q2W dosing regimen that are consistent with our Phase I expansion study.
In particular, among the eight evaluable monotherapy patients to date with reported first scan across Phase I and Phase II clinical studies, we have observed four responses, two stable disease, one of which was a 17% tumor volume reduction in uveal melanoma and two with progressive disease. Notably, we have now observed a PR at a ROR2 TmPS negative patient, which is likely to expand the applicable patient populations. We are continuing to collect data in the ongoing study and the remainder of patients in the targeted melanoma cohort will have had the opportunity to have first scan by year-end. There are also encouraging early responses in head and neck cancer at 2Q3W also with a new PR observed in ROR2 TmPS negative patient, which makes two out of two responses at the 2Q3W dose across Phase I and Phase II.
We are on track to complete all dosing regimens enrollment by year-end, and we'll continue to collect data on the ongoing study. The ROR2 melanoma indication recruitment has been assisted by enrolling target-agnostic patients, followed by a retrospective target expression analysis, both of which resulted in quicker enrollment and the opportunity to target a larger melanoma patient population. In the case of head and neck cancer, ROR2 is expressed in a significant portion of these patients and therefore is also not anticipated to benefit from a biomarker assay, particularly in view of the observed 2Q3W PR in a ROR2 TmPS negative patient, which maximize the potential applicable patient population. ROR2 positive lung cancer patients at Q2W, while we observed clinical benefit in terms of substantial stable disease and tumor volume reduction, there are no responses to date, and thus, we did not meet our internal criteria for advancing at this desk.
Further, in view of these results and our supportive AXL lung cancer data, we currently do not plan to internally explore the more frequent 2Q3W dose for this indication. Regarding the ovarian IIT interim analysis of 10 patients in each of the BA3011 and BA3021 Q2W cohorts demonstrated modest disease control, but did not meet our internal criteria for advancing at this dose. We currently do not plan to internally explore additional dosing regimens at this time for this indication. Now on to our other promising CAB assets. Beginning with our CAB-CTLA-4 antibody, BA3071, which is applicable in areas of high unmet need in treatment-refractory patients represents a sizable commercial opportunity. We have encouraging Phase I observations to date, and we continue to follow these patients progress.
In contrast to approved an earlier stage CTLA-4 blocking antibodies, BA3071 is designed to be conditionally and reversibly active in the tumor microenvironment. We believe this unique design enables our CAB-CTLA-4 antibody to have the potential to deliver efficacy with a manageable safety and tolerability profile. In particular, a safety profile with less immune-related adverse events across multiple tumor types may allow patients to stay on therapy for longer and achieve clinical benefit from this important immunotherapy. The Phase I/II trial is being conducted in tumors known to be responsive to CTLA-4 treatment, and we are continuing to evaluate safety and tolerability of BA3071 in monotherapy and in combination with nivolumab. As part of today's brief update, I'm happy to report that we have initiated the Phase II expansion cohort enrollment and remain on track for the Phase I data readout, which will be highlighted at our upcoming R&D Day on December 13th.
Next on to our potentially first-in-class Dual-CAB bispecific T-cell engager antibody , CAB-EpCAM x CAB-CD3 or BA3182. We previously announced FDA clearance of our IND for the treatment of advanced adenocarcinoma. And last quarter, we announced that the Phase I study was actively enrolling patients. Study is progressing nicely through the dose escalation part of the Phase I study, and we anticipate completion of the Phase I study with a full data readout remaining on track for next year. We believe that our Dual-CAB design has potential to address tremendous unmet need across multiple tumor types with the most common subtypes of adenocarcinoma, including colon, lung, breast, pancreas and prostate. I'd like to round out today's talk with a corporate update.
First, in addition to our leadership team. Recently, Dr. Bin Zhang joined BioAtla as Senior Vice President, Head of Clinical Development and Operations. Bin brings over 20 years of experience in clinical practice, early and late-stage drug development and asset management with a focus on oncology drug development. Prior to joining BioAtla, he held leadership roles with increasing responsibilities, including at Bristol-Myers Squibb, Ipsen Bioscience, and most recently as Senior Vice President, Head of Clinical Development at Pyxis Oncology brining over some clinical development activities of all oncology assets. His regulatory interaction experience coupled with his known track record of leading cross-functional teams will be instrumental as we advance clinical development efforts and strategic collaborations.
We are thrilled to have Bin on board with BioAtla. And finally, I'm pleased to report our progress with the medical and scientific communities with an additional abstract on BA3011 alone or in combination with nivolumab in patients with lung cancer, which was accepted for presentation at the upcoming IASLC conference this December. We also look forward to sharing these data and additional details around our CAB-AXL-ADC asset at our upcoming KOL event on December 4th. Moreover, we will present our Phase I CAB-CTLA-4, BA3071 study data at our upcoming R&D Day on December 13th. With that, I would now like to turn the call over to Rick to review the third quarter 2023 financials. Rick?
Richard Waldron: Thank you, Jay. Cash and cash equivalents as of September 30, 2023 were $141.3 million compared to $215.5 million as of December 31st, 2022. We now expect current cash and cash equivalents will be sufficient to fund planned operations including prioritized CAB programs into the second half of 2025. Research and development expenses were $28.4 million for the quarter ended December 30, 2023 compared to $19.8 million for the same period in 2022. The increase of $8.6 million was primarily driven by a $6.3 million increase in our clinical product development expenses, primarily related to the launch of our AXL UPS potentially registrational trial, and a $1.8 million increase in additional product development expenses.
We expect our R&D expenses to remain variable from quarter-to-quarter as we continue to advance our clinical programs, then decreasing after we complete enrollment and focus development on selected high potential indications. General and administrative expenses were $6.6 million for the quarter ended September 30, 2023 compared to $6.3 million for the same quarter in 2022. The $0.3 million change was attributable to an increase in professional services and consulting expenses for the 2023 period. We expect our G&A expenses to remain flat to moderately increasing to support development of our prioritized CAB programs. Net loss for the third quarter ended September 30, 2023 was $33.3 million compared to a net loss of $25.8 million for the same quarter in 2022.
Net cash used in operating activities for the nine months ended September 30, 2023 was $74.1 million compared to net cash used in operating activities of $66.1 million for the same period in 2022. The increase in net cash used in operating activities for the first nine months of 2023 is primarily due to an increase in research and development expenses related to our program development efforts as compared to the first nine months of 2022. And now, back to Jay.
Jay Short: Thank you, Rick. BioAtla is dedicated to deliver innovative, life-changing therapies to cancer patients. We observed that the CAB platform continues to demonstrate compelling clinical efficacy and safety across multiple therapeutic targets and formats in the most challenging cancer cases. As a result, we believe that there are mutually compelling opportunities for forming one or more strategic collaborations with major pharmaceutical partners that both accelerate and maximize our therapeutics opportunity. In addition to advancing collaboration discussions, we will continue to advance selected CAB assets that can address significant unmet medical needs in order to maximize shareholder value. With that, we will turn it back to the operator to take your questions.
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