BioAtla Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
March 26, 2024

There are 10 speakers on the call.

Operator

Greetings, and welcome to the Bio Atlas 4th 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. As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, Bruce Mackle with LifeSci Advisors.

Operator

Thank you, Mr. Mackle. You may begin.

Speaker 1

Thank you, operator, and good afternoon, everyone. With me today on the phone from Bio Atlas are Doctor. Jay Short, Chairman, CEO and Co Founder and Richard Waldron, Chief Financial Officer. Following today's call, Doctor. Eric Sievers, Chief Medical Officer and Sherry Lydic, Chief Commercial Officer, will join Jay and Rick for a short Q and A.

Speaker 1

Earlier this afternoon, BioAtlet released financial results and a business update for the Q4 full year ended December 31, 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 Bio Atlas' 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 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 to fund operations and expected R and 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 ks and subsequent quarterly reports on Form 10 Q.

Speaker 1

You are cautioned not to place undue reliance on these forward looking statements, which speak only as of today, March 26, 2024, and Bio Atlas 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?

Speaker 2

Thank you, Bruce, and thanks to everyone for joining us for our Q4 full year 2023 BioAgra earnings call. BioAgra is the inventor and leader in the development of novel therapies using a proprietary conditionally active biologics or cabs platform with improved selectivity for attacking tumor cells while avoiding healthy cells, thereby addressing critical unmet needs in oncology improve patients' lives. We made considerable progress in 2023 across all of our ongoing clinical programs, including the Phase II trials for our 1st in class CAB ABC product candidates, BA3011 and BA3011, targeting multiple solid tumor types. Our CAB CTLA-four IO antibody and our first dual cab bispecific EpCAM CD3 T cell engager. We continue the positive trajectory into 2024, focused on further advancing our prioritized CAB programs generating data sets that potentially enable us to move into 1 or more registrational trials in the second half of the year.

Speaker 2

We believe that these near term inflection points also support the formation of 1 or more strategic collaborations with major pharmaceutical partners this year, which can accelerate the development of selected 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 CABC-two forty four antibody BA-three thousand and seventy one, 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 2 data at 3 50 milligrams flat dose continues to mirror our Phase 1 dose escalation data in terms of low incidence and severity of immune related adverse events.

Speaker 2

In addition, I'm happy to report that we have cleared a higher dose of 700 milligrams with tocilizumab for the first two cycles and are now evaluating the unprecedented 1 gram dose level. This is important since previous studies demonstrated improved overall survival in metastatic cancers including melanoma with higher levels of CTLA-four inhibition. As a result, we are now enrolling patients at 700 milligrams in first line melanoma patients and in a significant targeted first line non small cell lung cancer population in combination with PD-one for readouts later this year. These data are also anticipated to position the company for 1 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-three thousand and seventy one, we are completing the Phase 2 expansion in treatment refractory melanoma and carcinoma with an initial data readout of approximately 20 patients in the 2nd quarter.

Speaker 2

As already noted, the safety and efficacy data from the Phase 1 study demonstrating both a confirmed partial response and a confirmed complete response for 2 out of 6 patients is encouraging using the 3 50 milligram dose. And now we are enrolling the remaining patients at the 700 milligram dose. With our evolving clinical data, we believe DA-three thousand and seventy one has the potential to be best in class CTLA-four that holds the promise to be used as often as a PD-one inhibitor and potentially expand the indications where combined immune checkpoint inhibition can be effective. In addition, the emerging safety profile suggests that BA-three thousand and seventy one with PD-one immune modulation may be suitable for further combining with CAB ADC therapies that target AXAL and or WAR2 to achieve synergistic durable tumor control. Now turning to our CAB WAR II ADCSS VA3021.

Speaker 2

For our ongoing Phase II trials and treatment refractory WRAR II agnostic patient populations, we previously reported encouraging responses in the Phase II melanoma and squamous cell carcinoma, the head and 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 Q2W regimen and 20 head and neck patients dosed using the more intense 2q3w regimen for a total of 32 head and neck patients. We anticipate having 2 plus scans in the melanoma cohort next month and 2 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 data sets, we believe BA-three thousand and twenty one is well positioned for a global strategic collaboration to maximize the potential of this cab ADC across multiple solid tumor indications. Onto our cabaxel ADC BA3011, Our Phase 2 potentially registrational study for undifferentiated pleomorphic sarcoma or UPS is on track to complete enrollment of approximately 20 axial agnostic patients at the 1.8 milligram per kilogram 2Q3W regimen next month with encouraging compliance and manageable safety.

Speaker 2

We anticipate having multiple scans across the patient group potentially enabling a meeting with the FDA to discuss the remaining portion of 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 2 Part 1 cohort enrollment as an oral presentation at the ESMO Sarcoma and Rare Cancers meeting earlier this month and showed disease control at 12 weeks for 43% of the 87 patients treated with BA3011 monotherapy using the less intense regimen of 1.8 milligram per kilogram Q2W. We believe this represents a promising disease control for patients with treatment refractory sarcomas. In the osteosarcoma cohort, we observed 2 partial responses out of 11 efficacy evaluable patients.

Speaker 2

The treatment was well tolerated associated with a manageable safety profile with no new safety signals to report. Now regarding our Phase 2 study in non small cell lung cancer. Last quarter, we reported multiple durable clinical responses with a differentiated safety profile among a challenging axial positive treatment refractory lung cancer population. Specifically among 15 patients with EGFR wild type tumors who had received prior PD-one treatment, we observed 5 partial responses with a median duration of response of approximately 5 months using 1.8 milligrams per kilogram Q2W every other week dosing. Toxicity was manageable and few high grade related treatment emergent AEs were reported.

Speaker 2

We believe multiple responses in a treatment refractory, axial positive, poor prognostic group such as this one is clinically meaningful and relevant, particularly since these patients have experienced failure of a median of 3 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 2Q3W 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 Q2 of this year. Next, onto our potentially 1st in class dual cab bispecific T cell engager antibody, cabepcam, cabcd3 or BA3182. EpCAM is a ubiquitous target expressed from the surface of cancer cells, which requires the use of our CAB technology to achieve optimal selectivity and safety.

Speaker 2

Our Phase onetwo dose escalation study continues to progress and is on track. We anticipate completion of the Phase 1 study with a full data readout anticipated in the second half of this year with potential initiation of a Phase 2 study also in the second half of this year. If shown to be safe and effective among cancer patients in role, 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 promising treatment modality with broad applicability across multiple tumor types. To further reduce the potential risk associated with neutropenia from off target toxicity, we developed a novel next gen carbohydrate linker system with superior serum stability, solubility and tumor specific payload release, yielding our 1st glyconjugate cadmectin-four ADC BA3361.

Speaker 3

At the

Speaker 2

upcoming AACR meeting in April, efficacy data will be presented demonstrating complete tumor regression in xenograft models, including superior efficacy compared to enfortumab vedotin analog in the patient derived pancreatic cancer model. We will also present both PK and toxicology data in non human primates as well as the influence of our linker technology in specific cancer models. These data indicate that our next gen CAB Nectin-four ADC petition is a more effective treatment with reduced We plan to submit the IND in April. And finally, I'm pleased to report our progress with the medical and scientific communities and important ongoing communications with numerous publications and presentations, including at conferences such as ESMO Sarcoma and Rare Cancers, SITC Spring and the AACR 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 Q4 and full year 2023 financials.

Speaker 2

Rick?

Speaker 4

Thank you, Jay. Research and development expenses were $22,700,000 for the quarter ended December 31, 2023, compared to $21,900,000 for the same quarter in 2022. The increase of $800,000 was due to clinical development expenses primarily related to the launch of our BA-three thousand and eleven UPS potentially registrational trial in 2023 and overall accelerated enrollment across our clinical trials in 2020 3, offset by a decrease in expense for our preclinical programs and selected clinical indications due to our program prioritization in 2023. We expect our R and D expenses to decrease overall in the first half of twenty twenty four due to recently completed enrollment in clinical trials for data sets expected to enable potentially General and administrative expenses were $5,900,000 for the quarter ended December 31, 2023, compared to $6,700,000 for the same quarter in 2022. The $800,000 decrease was primarily due to lower stock based compensation and D and O insurance premiums.

Speaker 4

Net loss for the quarter ended December 31, 2023 was $26,900,000 compared to a net loss of $27,600,000 for the same quarter in 2022. Net cash used in operating activities for the full year ended December 31, 2023 was $104,000,000 compared to net cash used in operating activities of $90,400,000 for the same period in 2022. Our cash used for the quarter ended December 31, 2023 was $29,800,000 Cash and cash equivalents as of December 31, 2023 were $111,500,000 compared to $215,500,000 as of December 31, 2022. We expect our cash utilization to decrease in the first half of twenty twenty four, allowing our current cash and cash equivalents to fund operations into the second half of twenty twenty five. And now back to Jay.

Speaker 2

Thank you, Rick. BioLava made considerable progress in 2023 across our ongoing clinical trials targeting various tumor types and we look forward to the multiple important milestones in the Q2 of this year, including initial data readout from our Phase 2 CTLA-four IO antibody, Phase 2 in both melanoma and head and neck cancer and evaluation of clinical benefit in axial agnostic patients in our Phase II non small cell lung cancer study. We are encouraged by the compelling clinical efficacy and safety that continues to emerge, highlighting our differentiated CAB technology across multiple therapeutic targets. With that, we will turn it back to the operator to take your questions.

Operator

Thank you. We will now be conducting a question and answer session. Thank you. Our first question comes from the line of Kelly Shi with Jefferies. Please proceed with your question.

Speaker 5

Hi, this is Dave on for Kelly Shi. I have a couple of questions, one on 3,011 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 UPS?

Speaker 2

Sherry, do you want to take that one to begin?

Speaker 6

Sure. Thank you In terms of the second I'll take the second part of your question. So the meeting would be focused on UPS since this is our, potentially registrational trial. So, we would look 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.

Speaker 7

Sure. I'm happy to take that. Thank you, Sherry. So, our goals with the FDA meeting are really to plot out together an agreeable registration path. And I think we've guided previously that that would be based on an overall response rate, with a certain durability.

Speaker 7

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 our path forward after that meeting.

Speaker 5

Great. Thank you for taking our question. Thank you.

Speaker 3

Thank you.

Operator

Our next question comes from the line of Kaveri Pullman with BTIG. Please proceed with your question.

Speaker 8

Yes, good evening. Congrats on the progress and thanks for taking my questions. For CTLA-four, 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 do you plan to enroll?

Speaker 2

Eric, do you want to start with that one?

Speaker 7

Sure. Thank you, Kaveri. 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 twenty twenty four. 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 1 gram.

Speaker 7

So we're really of the belief that higher dose levels will be very important in extending survival as other studies have shown.

Speaker 2

And I think I will 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.

Speaker 8

Got it. That's helpful. And for FCAM CD3 bispecific trial, I understand it's for multiple solid tumors, but are you enriching or have you seen enrichment for patients with certain tumor types? And can you set some expectations for what we will be seeing in second half and what would good data look like?

Speaker 2

I think obviously adenocarcinoma, but I think we're seeing some colorectal patients and then we would expect to see a continuation along those lines as we go through the different dose layers to the ultimate dose selection level. And our goal is to report out on those with multiple scans, very much similar to what we did with CTLA-four in December with that readout as we position for Phase 2 studies. Eric, you want to add anything to that?

Speaker 7

I think it covers it. More than 70% of tumors are adenocarcinomas. So we're we think we have plenty of coverage with this approach. And Cabari to your question, we're not needing to specifically pick patients based on target expression. EpCAM is so robustly expressed by tumors that we think that just using the adenocarcinoma approach will be getting patients likely to benefit.

Operator

Got it. Thanks for taking my questions. Thank you. Our next question comes from the line of Arthur He with H. C.

Operator

Wainwright. Please proceed with your question.

Speaker 3

Hey, good afternoon, JN team. Thanks for taking my question. So I just want to get your for the 3,071 and the 3021 update, is that going to be all together at the Q1 earnings call?

Speaker 2

No, it will be our expectation is 30.21. We will be giving top line updates. And The key update for 3,071, well, there could be an update on the dose escalation. We won't know for sure until we get a few weeks further down the road here since we're enrolling at the 1 gram level right now. But the first that is a possibility there, but we'll see as we get closer to time.

Speaker 2

I think for the readout of the monotherapy Phase 2 study with approximately 20 patients where majority have been recruited at 3 50 milligram flat dose and just a few remaining patients at the 700 milligram dose. That'll be sometime in June and latter part of June, I'm estimating, because we want to get as much scan data. If you remember back on 3,071, you definitely want to see 2 scans because you're initiating the immune system. So that one is going to give us just a little more time, but all pretty not very far away, quite frankly, coming quickly.

Speaker 3

Got you. Thanks for that. And my second question is, so regarding the next candidate, I just curious to try to pick your brain is why another ADC not a T cell engager? That's one. And the second question is why NAKTYN-four as a target?

Speaker 3

Thanks for that.

Speaker 2

Well, I think, 2 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-four. Number 1, there is an associated toxicity Secondly, as we're going to report on in April at AACR, we're seeing efficacy in tumors that were not addressable with the current marketed drug.

Speaker 2

And so we see an opportunity to move, expand indications and also improve on existing indications. And that's driven of course by our novel next gen carbohydrate linker, which reduces off target levels of off target toxicity that is a result of the payload coming off prior to entering the cancer cell area. And so in general, we see both of these assets having important opportunity for validated target. And in general, philosophically, I mean, you could ask the same question of CTLA-four. 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.

Speaker 2

And I think we can make that argument across several different targets when we apply our CAB technology, which improves that selectivity between for the cancer cell and protects the normal cell.

Speaker 3

I see. Thanks for the additional color. So if I may, can I squeeze one more? Just curious, I just quickly noticed the AACR plantation you're going to be doing in April.

Speaker 5

Could you just ask more on

Speaker 3

the tetravalent T cell engaged, I believe the B7 H3 target. What's the special of these design? I'm just curious.

Speaker 2

Well, I think it's what we refer to as kind of a butterfly design. In other words, we have 2 arms of the antibody that both combined to the tumor cells. So that's the tumor cell engager. And then we also have 2 arms that come off the light chains that can bind to the CD3 receptor. Now we've since at least terms of the EpCAM drug, know that we're binding to a single CD3 arm at a time, whereas we can still bind to 2 different antigens on the tumor cells.

Speaker 2

So but this increases your ability to increases the potency of the drug to have this tetravalent structure even in the case where one arm combined at a time like in the CD3 arm. Certainly you're going to get not only affinity, but also avidity in the 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 during manufacturing. It simplifies manufacturing and reduces cost of goods, which is also an advantage.

Speaker 3

Got you. Thanks, Jay. I'll talk to you soon.

Operator

Thank you. Our next question comes from the line of Ren Benjamin with Citizens JMP. Please proceed with your question.

Speaker 9

Hey, good afternoon guys. Thanks for taking the questions. As I think about 3,071, I guess one question is, now you're looking at the 1 gram dose level. At what point do you kind of stop dosing higher? Or can you just continue to go higher until you reach a DLT?

Speaker 9

And then I guess the second question is when I'm thinking about the melanoma non small cell combination with pembro cohorts for which we'll have data readout in the second half of this year. Can you talk roughly metrics that you might need to meet? 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 the safety aspect? And the same kind of question non small cell lung cancer?

Speaker 2

Eric, do you want to start on this one?

Speaker 7

Sure. I think I'll take a start and then hand to Sherry. You had a really interesting question about really how high to go with CTLA-four inhibition. It's really striking to look back at earlier randomized trials of ipilimumab10 per kilo versus 3 per kilo and the survival benefits are really quite striking at multiple years of follow-up. However, Ipi10 per kilo was associated with considerable toxicity.

Speaker 7

So most sponsors that are pursuing CTLA-four antibody really want to push the dose to achieve high exposures. And then, we also want a good high concentration trough in our pharmacokinetics, so that CTLA-four blockade lingers for the full 3 weeks between doses. So our current plan is to treat the patients at 1 gram every 3 weeks and we don't plan to go higher. We felt that that represents 14.2 mg per kilogram if you compared it to the ipi dosing. And I think we can use that and just have a broad goal of giving as much CTLA-four blockade as early in our cancer patients' treatment as possible and make this something that based on tolerability and its efficacy would be reached for as often as a PD-one inhibitor.

Speaker 7

Sherry, do you want to address the questions of regarding what we would see in the context of melanoma in non small cell lung cancer? Sure.

Speaker 6

Sure. Thank you, Eric, and thank you, Ren, for your question. I think basically what we would like is to be meaningfully better than the current marketed standard of care. So what that means is meaningfully better not only in terms of efficacy, but also tolerability. So providing a regimen that will allow a patient to really experience the full benefit of the therapy.

Speaker 6

So in the context of melanoma, whether that means being meaningfully better than Opdivo, Yervoy, in terms of efficacy or meaningfully better than Opdivo, Yervoy, we aim to be meaningfully better than what those regimens currently provide.

Speaker 9

Got it. And what about for non small cell?

Speaker 6

Yes. On the

Speaker 2

small cell side, I'll just add and jump in here for a second. As you noticed, we mentioned that we're doing a targeted population with significantly a large a significant large population, but it's a subset of all non small cell lung cancer patients. And we're going to talk a bit more about that in future conference, but at the moment, we're just simply keeping that at a high level at this point.

Speaker 9

Got it. Okay. And just maybe just going back to Eric's answer, just in regards to the 14.2 mix per kg, significantly higher than what's been evaluated prior. Do we have a sense as to kind of the PKPD at this point and how much sort of receptor occupancy or blocking we're already getting? Any sort of color there would be helpful.

Speaker 2

Eric, I'll just jump in for a moment. I think that a lot of the studies that were done prior with ipilimumab have that you do continue to get an advantage up to 10 mgs per kg. We don't have the data of 14 point 2 mgs per kg, but we'll definitely be comparing the 10 mgs to the 14.2 mgs. And our belief is we may not quite have saturated it yet at the 10, but the data is pretty clear when you compare 1 going 1, 3 and up to 10 mgs per kg that you continue to get benefits. So I think though your point is it's a reasonable question though at what point does that effort start to become saturated.

Speaker 2

And I think certainly there's plenty of incentive to check out those 1 gram level. And we'll hope to report out on that in the future.

Speaker 7

And Wren, 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 pretty standard manner. There are really no PK surprises to date.

Speaker 9

Excellent. Thanks guys for taking the questions.

Operator

Thank you. Yep. Thank you. There are no further questions at this time. I would like to turn the floor back over to Jay Short for any closing comments.

Speaker 2

Thanks everyone for your attention and we're 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.

Powered by Quartr

Key Takeaways

  • BA3071 (CTLA-4 CAB antibody) Phase II at 350 mg shows low immune-related AEs, cleared 700 mg with tocilizumab and now testing 1 g; enrolling first-line melanoma and NSCLC with PD-1 combo to enable potential registrational trials in H2 2024.
  • BA3021 (CAB WAR II ADC) In Phase II, 28 melanoma and 32 head & neck cancer patients have been dosed; scans begin in April/May with topline data expected in Q2 2024, positioning for global strategic collaboration.
  • BA3011 (CABaxel ADC) UPS cohort enrollment nears completion, with Phase 2 Part 1 showing 43% disease control at 12 weeks in 87 refractory sarcoma patients and two PRs in osteosarcoma; planning an FDA meeting in H2 2024 on the registrational path.
  • BA3182 (dual CAB bispecific EpCAM-CD3 engager) Phase I/II dose escalation on track, aiming for full data readout and Phase II initiation in H2 2024, targeting a broad range of metastatic adenocarcinomas without patient pre-selection for target expression.
  • Financial position: Q4 2023 net loss was $26.9 M (R&D $22.7 M), year-end cash of $111.5 M supports operations into H2 2025, with expected reduced cash burn in H1 2024.
AI Generated. May Contain Errors.
Earnings Conference Call
BioAtla Q4 2023
00:00 / 00:00