Q4 2023 Bioatla Inc Earnings Call
Participants
Jay Short; Chairman, CEO, and Co-Founder; BioAtla, Inc.
Richard Waldron; CFO; BioAtla, Inc.
Sheri Lydick; Chief Commercial Officer; BioAtla, Inc.
Eric Sievers; CMO; BioAtla, Inc.
Bruce Mackle; Moderator; LifeSci Advisors LLC
Kelly Shi; Analyst; Jefferies Financial Group, Inc.
Kaveri Pohlman; Director; BTIG LLC
Arthur He; Analyst; H.C. Wainwright & Co., LLC
Reni Benjamin; Analyst; Citizens JMP Securities LLC
Presentation
Operator
Greetings, and welcome to the BioAtla's fourth quarter and full year 2023 earnings call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, Bruce Mackle with LifeSci Advisors. Thank you. Mr. Michael, you may begin.
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 Richard Waldron, Chief Financial Officer. Following today's call, Dr. Eric Sievers, Chief Medical Officer; and Sheri Lydick, Chief Commercial Officer, will join Jay and Rich for a short Q&A. Earlier this afternoon, BioAmber released financial results and a business update for the fourth quarter and full year ended December 31, 2023.
A copy of the press release and corporate presentation are available on the Company's website and 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 BioAtlas' business plans and prospects and whether its 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 and clinical trials, expectations with respect to enrollment and dosing in US 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 to fund operations and expected R&D 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 annual report on Form 10 K and subsequent quarterly reports on Form 10 Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, March 26th, 2024, and BioAmber 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, everyone, for joining us for our Fourth Quarter Full Year 2023 BioAmber Earnings Call. Bi-level is the inventor and leader in the development of novel therapies using a proprietary conditionally active biologics or CAPS platform with improved selectivity for attacking tumor cells while avoiding healthy cells, thereby addressing critical unmet needs in oncology to improve patients' lives, we made considerable progress in 2023 across all of our ongoing clinical programs, including the Phase two trials for our first in class cab ADC product candidates be a 30 11 NDA 30 21, targeting multiple solid tumor types, our CAB CTLA-4 IO antibody, and our first dual cam bispecific, Abcam CD. three T cell engager.
We continue the positive trajectory into 2024, focused on further advancing our prioritized CAP programs, generating data sets that potentially enable us to move into one or more registrational trials in the second half of the year. We believe that these near-term inflection points also support the formation of one or more strategic collaborations with major pharmaceutical partners this year, which can accelerate the development of selected assets and maximize their market opportunities. Additional details related to what I'm going to provide are available in today's press release and our updated company presentation, both of which are available on our website.
I will now review our latest updates beginning with our CAB CTLA-4 antibody D, a 30 71, which is applicable in areas of high unmet need across multiple solid tumor indications both for refractory and for first line patients and represents a sizable commercial opportunity. We are pleased to report that our Phase two data at 350 milligrams flat dose continues to near our Phase one dose escalation data in terms of low incidence and severity of immune-related adverse events. In addition, I'm happy to report that we have cleared a higher dose of 700 milligrams with tislelizumab for the first two cycles and are now evaluating the unprecedented one gram dose level.
This is important since previous studies demonstrated improved overall survival in metastatic cancers, including melanoma, with higher levels of CTLA-4 inhibition. As a result, we are now enrolling patients at 700 milligrams in the first-line melanoma patients and in a significant targeted first-line non-small cell lung cancer population in combination with PD-1 for readouts later this year. These data are also anticipated to position the company for one or more potentially registrational trials in first-line indications in the second half of this year.
In addition, as part of our evaluation of safety and tolerability of BA. 30 71, we are completing the Phase two expansion in treatment refractory melanoma and carcinoma with an initial data readout of approximately 20 patients in the second quarter. As already noted, the safety and efficacy data from the Phase one study, demonstrating both the confirmed partial response and the confirmed complete response for two out of six patients is encouraging using the 350 milligram dose and now we are enrolling the remaining patients at the 700 milligram dose with our evolving clinical data. We believe DA. 30 71 has the potential to be best in class CTLA-4 as it holds the promise to be used as often as a PD-1 inhibitor and potentially expand the indications where combined immune checkpoint inhibition can be effective.
In addition, the emerging safety profile suggests that be a 30 71 with PD1 immune modulation may be suitable for further combining with CAB ADC therapies that target actual end or were to achieve synergistic durable tumor control.
Now turning to our cab war to ADCSSDA. 30 21 for our ongoing Phase two trials in treatment refractory were two agnostic patient populations. We previously reported encouraging responses in the Phase two melanoma and squamous cell carcinoma of the head neck studies. As part of today's update, we now have both 28 melanoma patients and 12 head-and-neck patients dosed using the 1.8 milligram per kilogram Q. two W. regimen and 20 head and neck patients dose using the more intense two Q. three W. regimen for a total of 32 head and neck patients. We anticipate having two plus gains in the melanoma cohort next month and two plus scans in the head and neck cohort in May with anticipated top line data readouts for both during our Q1 earnings call in May.
Given the encouraging emerging datasets, we believe the A. 32 one is well positioned for global strategic collaboration to maximize potential of this cab ADC. across multiple solid tumor indications onto our CAB axle ADCBA. 30 11 our Phase two potentially registrational study for undifferentiated polymorphic sarcoma or UPS is on track to complete enrollment of approximately 20 as for diagnostic patients at the 1.8 milligram per kilogram two Q. three W. regimen next month with encouraging compliance and manageable safety. We anticipate having multiple scans across the patient group, potentially enabling a meeting with the FDA to discuss the remaining portion of the potentially registrational study in the second half of this year. We also reported clinically meaningful antitumor activity among patients with treatment refractory bone and soft tissue sarcomas.
Which remain a profound and tractable unmet need for new treatment options. We presented these data from Phase two part one cohort enrollment as an oral presentation at the as most common rare cancers meeting earlier this month and showed disease control at 12 weeks for 43% of the 87 patients treated with BA. 30 11 monotherapy using the less intense regimen of 1.8 milligram per kilogram Q. two W. We believe this represents a promising disease control rate for patients with treatment refractory sarcomas. In the osteosarcoma cohort, we observed two partial responses out of 11 efficacy evaluable patients. The treatment was well tolerated associated with a manageable safety profile with no new safety signals to report.
Now regarding our Phase two study in non-small cell lung cancer. Last quarter, we reported multiple durable clinical responses with a differentiated safety profile among a challenging actual positive treatment refractory lung cancer population, specifically, among 15 patients with EGFR wild-type tumors who had received prior PD-1 treatment. We observed five partial responses with a median duration of response of approximately five months using 1.8 milligrams per kilogram Q. two W. every other week, dosing toxicity was manageable and few high grade related treatment emergent AEs were reported. We believe multiple responses in a treatment refractory actual positive poor prognostic group such as this one is clinically meaningful and relevant, particularly since these patients have experienced failure of a median of three prior lines of therapy as part of today's update.
We have enrolled 33 target agnostic patients using the more intense 1.8 milligram per kilogram two Q. three W. regimen across both squamous and non-squamous patients. We are on track to evaluate clinical benefit in the target agnostic non-small cell lung cancer non-squamous population in the second quarter of this year.
Next onto our potentially first-in-class dual cab bispecific T-cell engager antibody cab, EpCAM cab CD. three or VA. 31 82. Epcam is a ubiquitous target expressed on the surface of cancer cells, which requires the use of our TAP technology to achieve optimal selectivity and safety. Our Phase one two dose escalation study continues to progress and is on track. We anticipate completion of the Phase one study with a full data readout anticipated in the second half of this year with potential initiation of a Phase two study also in the second half of this year is shown to be safe and effective in lung cancer patients enrolled. Our CAB enabled T cell engager has the potential to treat patients with a wide range of metastatic tumors, including cancers of colon, lung breast, pancreas and prostate, among others.
As we have previously discussed, ADCs are a promising treatment modality with broad applicability across multiple tumor types to further reduce the potential risk associated with neutropenia from off-target toxicities. We developed a novel next-gen carbohydrate linker system was superior serum stability, solubility and tumor-specific payload release yielding our first glyco conjugate, CADx Nectin-4 ADC, PA. 33 to 61 at the upcoming ACR meeting in April, efficacy data will be presented demonstrating complete tumor regression in xenograph models, including a superior efficacy compared to the photomask. The Dayton analog and the patient derived pancreatic cancer model.
We will also present both PK and toxicology data in nonhuman primates as well as the influence of our linker technology and specific cancer models. These data indicate that our next-gen CAB Nectin-4 ADC petition is a more effective treatment with reduced toxicity. We plan to submit the IND and ample. And finally, I'm pleased to report our progress with the medical and scientific communities, an important ongoing communications with numerous publications and presentations, including conferences such as asthma, sarcoma and rare cancers. Since the spring and the ACR Annual Meeting in April, which can be found on our website.
With that, I would now like to turn the call over to Rick to review the fourth quarter and full year 2023 financials. Rick?
Richard Waldron
Thank you, Jane. Research and development expenses were $22.7 million for the quarter ended December 31st, 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 CA 30 11 UPS, our potentially registrational trial in 2023 and overall accelerated enrollment across our clinical trials in 2023, offset by a decrease in expense for our preclinical programs in selected clinical indications due to our program prioritization in 2023, we expect our R&D expenses to decrease overall in the first half of 2024 due to recently completed enrollment in clinical trials for data set expected to enable potentially registrational trials for our ADC programs, VA 30 21 and VA 30 11 general and administrative 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 31st, 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 31st, 2023 was $104 million compared to net cash used in operating activities of $90.4 million for the same period in 2022. Our cash use for the quarter ended December 31st, 2023 was $29.8 million. Cash and cash equivalents as of December 31st, 2023 were $111.5 million compared to $215.5 million as of December 31st, 2022 we expect our cash utilization to decrease in the first half of 2024, allowing our current cash and cash equivalents fund operations into the second half of 2025 and now back to Jay.
Jay Short
Thank you, Rick. All other made considerable progress in 2020 through cross our ongoing clinical trials targeting various tumor types, and we look forward to the multiple important milestones in the second quarter of this year, including initial data readout from our Phase two CTLA-4 IO antibody, Phase two in both melanoma and head and neck cancer on the evaluation of clinical benefit and Axl agnostic patients in our Phase two non-small cell lung cancer study. We are encouraged by the compelling clinical efficacy and safety that continues to emerge highlighting our differentiated cap technology across multiple therapeutic targets. With that, we will turn it back to the operator to take your questions.
Question and Answer Session
Operator
(Operator Instructions) Kelly Shi, Jefferies.
Kelly Shi
I Hi. This is Dave on for Kelly Shi. I have a couple of questions. One on three zero one one in UPS. Maybe if you can talk about your expectation and what you anticipate from the meeting from the FDA meeting that you plan in second half also, will you be discussing additional indication or will it be only for you?
Jay Short
Yes, Sherri, do you want to it's about 1 billion and choice.
Sheri Lydick
Thank you for the question. And Dave, in terms of the second, I'll take the second part of your question. So the meeting would be focused on UPS. And this is our, a potentially registrational trial. So it was enough to discuss the data set that we had generated with the first 20 patients in terms of efficacy and tolerability. And I think I would pass the first part of your question over to Eric for additional comments.
Eric Sievers
Sure. I'm happy to say that. Thank you, Sherry. So our goals with the FDA meeting are really to plot out together and agreeable registration path. And I think we've guided previously that that would be based on an overall response rate with a certain durability on. We'll also be talking with the agency about Project Optimus and whether the multiple different dosing regimens that we've explored in UPS are sufficient to achieve the Project Optimus guidelines, and we then hope to be able to provide guidance on on our path forward after that meeting.
Kelly Shi
Great. Thank you for taking our question.
Richard Waldron
Thank you.
Jay Short
Thank you.
Operator
Kaveri Pohlman, BTIG.
Kaveri Pohlman
Yes, good evening. Congrats on the progress and thanks for taking my question, I foresee VLA-4 Any additional color you can provide on the first line, melanoma and non-small cell lung cancer trials? Are these going to be single-arm trials and how many patients you plan to enroll?
Jay Short
Well, you want to I'll start with that one.
Bruce Mackle
Sure. And thank you for very beginning. So we would expect to enroll about 15 to 20 patients in each of our first-line melanoma cohort and the first line targeted non-small cell lung cancer by the end of the second half of 2024. We hope that this data set both in melanoma and non-small cell lung cancer will help guide next steps for us. And I also want to emphasize, as Jay did that we've passed the 700 milligram dose which is equivalent to a 10 per kilo dosing and are now evaluating one gram. So we're really on the belief that a higher dose levels will be very important and extending survival as other studies have shown.
Jay Short
And I think I'll just add, I think our goal here is from these studies is to inform us and allow the positioning for registrational trials which in that case would be randomized studies.
Kaveri Pohlman
That's helpful.And for EpCAM CD. three bispecific trial, I understand it is for multiple solid tumors, but are you enriching or have you seen an enrichment for patients with certain tumor types? And can you set some expectations for what we will be seeing in second half?
Jay Short
And what would good data look like but the I think, obviously adenocarcinoma, but I think we're seeing some colorectal patients that we would expect to see continuation along those lines as we go through the different dose layers as to the ultimate dose selection level and what our goal is to report out on those with multiple scales, very much similar to what we did with CTLA-4 in December with that readout as we position for Phase two studies. Erik, do you want to add anything to that?
Bruce Mackle
I think that covers it from a more than 70% of tumors are adenocarcinomas. So where we think we have plenty of coverage with this approach. And compared to your question, we're not needing to arm specifically up pick patients based on target expression of EpCAM is so robustly expressed by tumors that we think that just using the adenocarcinoma approach, we'll be getting patients likely to benefit.
Kaveri Pohlman
Got it. Thanks for taking my question.
Jay Short
Thank you.
Operator
(Operator Instructions) Arthur He, H.C. Wainwright.
Arthur He
As you know, Jay and team, thanks for taking my questions. So I just wanted to get your for the 30 30, 71 and the 30 21 update that will be all together at the first quarter earnings call. Notably, our expectation of 30 21 will we will be giving top-line updates and key updates for 37?
Jay Short
The one well, that could be an update on the dose escalation up to it. We won't know for sure to get a few weeks at further down the road here since we're enrolling at the one gram level right now, but the first part of that as a possibility there, but we'll see as we get closer to time. I think for the readout of the monotherapy Phase two study with approximately 20 patients where we look set a majority have been recruited at three 50 milligram flat dose and just a few remaining patients at the 700 milligram dose that will be sometime in June and latter part of June.
I'm estimating because we want to give us much scan data, if you remember back on 30 70 well, you definitely want to see two scans because you're and initiating the immune system so that we know we're going to give it just a little more time, but all pretty much gone very far away, quite frankly, coming quickly.
Arthur He
Got you. Got you. Thanks for that. And my second question is and so regarding the next candidate. I just curious to us tried to pick your brain is why another ADC not a TC. T cell engager? That's one. And the second is on why Nectin-4 as a target. Thanks for that.
Jay Short
Well, I think two things we have both we have an ADC that just happened to be ready first. And then we also have a bispecific, which I believe we've reported on in previous conferences. But I think that there are a couple of reasons why Nectin-4, number one, there is an associated toxicity with the current marketed Nectin-4 that limits its applicability.
Secondly, as we're going to report on in April at a CR, we're seeing efficacy in tumors that were not addressable with the current marketed drugs so we see an opportunity to move expand indications and also improve on existing indications. And that's driven, of course, by a novel, but still on a carbohydrate linker, which reduces off-target levels of off-target toxicity. That is a result of the payload coming off prior to entering the the cancer cell. And so in general, we see both of these assets having an important opportunity for validated targets.
Arthur He
I will generalize. But what is optically? I mean, you could ask the same question of CTLA-4. You know, here's a drug with incredible opportunity, but the toxicity has been very difficult to manage and has been used in very limited extent, relative to what its potential is. And I think we can make that argument across several different targets when we apply our CAM technology, which improves that selectivity between for the cancer cell and protects the normal cell.
I think, Ben, thanks for the additional color. So if I may. Can I squeeze one more? Just curious, I just quickly noticed the ACR on plantation. You're going to you're going to be doing it in April or could you tell us more on the tetravalent T-cell engager Type B, I believe that B7-H3 targets. What's the what's the special of these design? I'm just curious.
Jay Short
Well, I think it's a good or we refer to as tenants butterfly design. In other words, we have two arms of the antibody that both can bind to the tumor cells against the tumor cell engager. And then we also have two arms to that come off the light chains that combined to the CD. three receptor. Now we sense at least in terms of the Abcam drug. Now that were binding to a single CD. three arm at a time, whereas we can still bind to two different antigens on the tumor cell.
So but this certainly increases your ability to it increases the potency of the drug to have this Tetra available structure, even in the case where one arm combined at a time like in season three on certainly is going to get not only affinity, but also avidity and tumor targeting portion. So it's a very nice design from that perspective. And secondly, because there's only one form of this antibody that can be generated and bearing manufacturing and simplifies manufacturing and reduces cost of goods, which is also an advantage that you think will shake out competition.
Operator
Reni Benjamin, Citizen's GMP.
Reni Benjamin
Good afternoon, guys. Thanks for taking the questions. As I think about 30 71, I have one question is, you know, now you're looking at the one gram dose level. At what point do you kind of stop dosing higher or can you just continue to go higher until you on reach of DLT. And then I guess the second question is when I'm thinking about the melanoma non-small cell combination with pembro cohort for which we'll have data a data readout in the second half of this year?
And can you talk roughly kind of metrics that you might need to to me, like, for example, in melanoma, should I be thinking about you guys beating or trying to beat nivo plus Yervoy from both an efficacy and safety perspective? Or are you more concerned about on the safety aspect and the same kind of question for now. So if you want to start on this one for sure.
Eric Sievers
I think I'll take a start and then hand to Sheri. You had a really interesting question about really how high to go with CTLA-4 inhibition on. It's really striking to look back at earlier randomized trials of, if you remember, at 10 per kilo versus three per kilo and the survival benefits are really quite striking at multiple years of follow-up. However, ipi 10 per kilo was associated with considerable toxicity. So on most of sponsors that are pursuing CTLA-4 antibody, you really want to push the dose and to achieve high exposures. And then we also want on a good high on a concentration trough and our pharmacokinetics. So that CTLA-4 blockade lingers for the full three weeks between doses. And so our current plan is to treat the patients at one gram every three weeks, and we don't plan to go higher.
Jay Short
We felt that that represents 14.2 milligrams per kilogram if you compare to the ipi dosing. And I think I think we can use that and just have a broad goal of giving as much CTLA-4 blockade as early in our cancer patients treatment as possible and make this something that based on tolerability and its efficacy would be reach for us often as a PD-1 inhibitor. Sherry, do you want to address the questions of regarding what we would see in the context of melanoma and non-small cell lung cancer?
Arthur He
Sure. Sure. Thank you, Eric, and thank you, Ben, for your question. And I think basically what we would like is to be meaningfully better then on the current marketed standard of care as to what that means is meaningfully better and not only in terms of efficacy, but also tolerability. So providing a regimen that helps we'll allow a patient to we really experienced the full benefit of of the therapy. And so in the context of melanoma, don't know whether that means being meaningfully better than and up to lag in terms of efficacy are meaningfully better than a pivotal year. I believe we aim to be meaningfully better than it's regimens currently.
Reni Benjamin
Got it. And I and I and what about for non-small cell? As you know, both of those just out and jump in here for a second. As you noticed, we mentioned that we're doing a targeted population with a significantly large population, but a subset of all non-small cell lung cancer patients. And we're going to talk a bit more about that in a future conference because at the moment, we're just simply keeping that at a high level at this point.
Jay Short
Okay. And just maybe just going back to <unk> and Eric's answer, just in regards to the 14.2 mix for QiG significantly higher than what's been evaluated on prior. Do you have a sense as to kind of the there PKPD. at this point and how much sort of receptor occupancy or blocking we're already getting any sort of color there would be first, I'll just jump in for a moment. I think that a lot of the studies that were done prior with ipilimumab have shown that you do continue to get it advantage up to 10 migs per kg. We don't have the data of 14.2 megs per kg, but we'll definitely be comparing the 10 to the 14.2.
And our belief is we may not have quite a saturated it yet at all of the 10. But the data is pretty clear when you compare one going one three and up to 10 migs per kilo that you continue to get benefits. So I think though Your point is reasonable, it's a reasonable question at what point does that our efforts start to become saturated. And I think so certainly there's plenty of incentive to check out this one gram level. And well, we'll hope to report out on that in the future.
Bruce Mackle
And then maybe I'll jump in here with your question about the PK. So as these are conditionally binding antibodies, we would need to do tumor biopsies to explore receptor occupancy because the antibody was designed to explicitly not bind in the periphery. So it turns out to be a more challenging question to answer and one that we haven't done those biopsies in humans to characterize receptor occupancy.
And then your question about PK. is that it is really behaving in a in a pretty standard on manner there really no PK surprises to date.
Reni Benjamin
Excellent. Thanks, guys for taking the questions. Thank you.
Eric Sievers
Yes, thank you.
Operator
There are no further questions at this time. I would like to turn the floor back over to Jay Short for any closing comments.
Jay Short
Both So everyone for your attention and looking forward to a very exciting second quarter. We'll be talking to you soon. Thank you.
Operator
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
