BioAtla Q1 2024 Earnings Call Transcript

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May 14, 2024

There are 11 speakers on the call.

Operator

Greetings, and welcome to the Bio Atlas First Quarter 2024 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 is now my pleasure to introduce your host, Bruce Mackle with LifeSci Advisors.

Operator

Thank you, Bruce. 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 Doctor. Eric Sievers, Chief Medical Officer Sherry Lydic, Chief Commercial Officer and Richard Waldron, Chief Financial Officer. Following today's call, the team will participate in a short Q and A.

Speaker 1

Earlier this afternoon, BioAtlet released financial results and a business update for the Q1 ended March 31, 2024. A copy of that 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, achievements of milestones, 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 expectations regarding R and D expenses and cash burn. 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, May 14, 2024, and BioAtlet disclaims any obligation to update such statements to reflect future information, events or circumstances, except as required by law.

Speaker 1

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 Q1 2024 BioElla earnings call. Additional details related to what we will share today are available in today's press release and our updated company presentation, both of which are available on our website. We continue to make considerable progress across all of our ongoing clinical programs. We are pleased to share our recent encouraging data readouts for our CABOR-two ADC and highly treatment refractory head and neck cancer patients who had a median of 3 prior lines of treatment. As illustrated in the best overall response slide of our corporate presentation, many patients achieve rapid and deep tumor control with 38% of patients responding.

Speaker 2

Having observed an 86% disease control rate, we believe these findings support use in earlier line settings. In addition, in view of the manageable safety profile, this holds considerable promise for future combination therapies. Given the strength of the data we observed with TAVR-two ADC, especially at the more intensive 2q3w dosing regimen, we plan to meet with the FDA in the second half of this year for guidance on a potentially registrational trial. We obtained multiple responses and encouraging clinical benefit using the less intense Q2W dose of our CABOR-two ADC in melanoma. However, we did not meet our internal bar.

Speaker 2

We do believe though that our CABOR-two ADC at the more intensive regimen has potential in melanoma and other indications including triple negative breast cancer where we observed tumor reduction in our earlier Phase 1 study. However, due to our ongoing prioritization, we do not plan to explore the more intensive regimen at this time. Next, I will cover our ongoing Phase III trial with our cab CTLA-four IO antibody. Our Phase 1 study, which was expanded to a higher dose due to the encouraging safety results is progressing well. We've more than doubled the number of treated patients since our first data disclosure late last year and we have observed multiple responses at the 3 50 milligram dose in combination with PD-one.

Speaker 2

We are pleased to report that our ongoing Phase 2 study echoes our earlier report as very few immune related adverse events have been observed to date, which is consistent with the anticipated benefits of our conditional binding technology. In addition, the observed safety profile also continues to hold now that we are treating patients at the 700 milligram flat dose or approximately 10 milligram per kilogram. We also remain on track to clear the DLT observation period with the unprecedented 1 gram dose later this quarter. The manageable safety at this high dose allows us to approach clinic. As for our cabaxel ADC, we completed dosing patients in the first portion of our potentially registrational trial in undifferentiated pleomorphic sarcoma in April.

Speaker 2

We also remain on track to evaluate clinical benefit of the AXAL ADC in target agnostic cancer patients later this quarter. Finally, the Phase 1 dose escalation trial with our 1st dual cab bispecific EpCAM CD3 T cell engager remains on track for readout in the second half. As we are now into the Q2 of 2024, we are focused on finalizing data readouts and reports for our VOR2 and C24 assets for meetings with the FDA to obtain guidance on 1 or more potentially registrational trials in the second half of this year. In addition, we are advancing our discussions with potential pharmaceutical partners on selected preclinical and clinical assets to both accelerate their development and maximize their market potential. I will now turn the call over to Eric, who will provide additional insights and details on our WAR2 and CTLA-four assets.

Speaker 2

Eric?

Speaker 3

Thank you, Jay. Beginning with our CABRAR-two ADC, ozariftumab vedotin and the target agnostic head and neck cancer indication, we have enrolled a total of 33 patients who had a median of 3 prior treatment regimens, ranging from 1 to 6 prior lines of treatment. 21 received more intensive day 1 and 8 dosing in 3 week cycles and 12 received every other week dosing. Among the 29 who were evaluable for response assessment, 11 responses were documented and 5 responses are now confirmed to date. Notably, 4 of 5 confirmed responses occurred in patients who received the ADC as second or third line therapy.

Speaker 3

Further follow-up will be required to provide a reliable estimate of the response duration. Importantly, responses were observed regardless of ROAR-two target expression from pretreatment tumor biopsies evaluated by immunohistochemistry. As of the safety data cut in March, only one patient discontinued treatment due to a treatment related adverse event, which was peripheral neuropathy. Collectively, these data support advancing to earlier lines of therapy, potentially in combination with PD-one inhibition in the first line setting. A meeting with the FDA is anticipated in the second half of the year to discuss potential registrational trial approaches.

Speaker 3

Moving now to our CAB CTLA-four antibody, evalstitug. Over the past 25 years, multiple lines of clinical evidence have shown that increased exposure of CTLA-four blockade in combination with PD-one inhibition drives long term survival benefits. At the same time, most oncologists prescribe currently approved CTLA-four blocking antibodies at relatively low doses because a high rate of immune related adverse events limit tolerability. We designed a VALSTETUG to preferentially bind CTLA-four in the acidic tumor microenvironment to avoid binding in normal healthy tissues and lymph nodes. We believe that valsitug will be better tolerated, enabling more patients to receive clinical benefit from CTLA-four inhibition.

Speaker 3

Last quarter, we announced confirmed responses for 2 of 6 treatment refractory patients using the 3 50 milligram dose in combination with PD-one antibody. As part of today's update, another response has now been achieved in a melanoma patient whose evalstatag dose was increased from 70 milligrams to 3 50 milligrams given every 3 weeks, providing additional evidence that higher doses drive clinical benefit. As Jay mentioned, patients are tolerating the unprecedented 1 gram dose level that we are presently evaluating as a part of our continued dose escalation. We continue to enroll in the Phase 2 first line melanoma and non small cell lung cancer combination cohorts at the 700 milligram flat dose. We are on track for additional data readouts later this year.

Speaker 3

Investigators are enthusiastic to use a CTLA-four inhibitor at higher doses in highly treatment refractory cancer patients, and we will report a Phase 1 update at ASCO on June 1. Shifting to our registration plans. We are now focused on the marked unmet need among patients with newly diagnosed metastatic or unresectable BRAF mutated melanoma will account for approximately half of patients with melanoma. Our strategy is informed by 3 key findings from large prospective clinical trials. First, BRAF patients should receive checkpoint inhibitor treatment before BRAF inhibitors.

Speaker 3

2nd, combined use of CTLA-four and PD-one blockade helps drive both progression free and overall survival. 3rd, higher CTLA-four doses meaningfully and specifically improve overall survival. Notably, improved progression free survival for this patient subgroup first appeared at just 3 months, suggesting that adding CTLA-four inhibition quickly achieves tumor control for these BRAF melanoma patients. We believe that our conditionally binding CTLA-four antibody can safely achieve high unprecedented levels of CTLA-four blockade in the tumor microenvironment, while largely avoiding CTLA-four inhibition in normal tissues. We are now designing an efficient, blinded, randomized pivotal trial employing evalstotag plus pembrolizumab for newly diagnosed patients with BRAF mutated metastatic or unresectable melanoma.

Speaker 3

We anticipate FDA feedback in the second half of this year, positioning us to initiate the potentially registrational trial by year's end. I would now like to turn the call over to Sherri to provide a few comments on the market opportunities for these agents. Sherri?

Speaker 4

Thank you, Eric, and good afternoon, everyone. Continuing with our tab CTLA-four antibody avelcitab, Based on our evolving Phase 1 data, we continue to believe evalsitug 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. There is tremendous opportunity across many solid tumors for evalsetope, but we are focused initially on BRAF mutated metastatic melanoma is approximately $8,000,000,000 annually and is expected to grow to over $11,000,000,000 by 2028. BRAF mutations are present in approximately 50% of malignant melanoma patients and first line standard of care remains immunotherapy regardless of BRAF status. As Eric noted earlier, documented clinical benefits of adding an anti CTLA-four to a PD-one inhibitor are particularly striking in BRAF mutated patients.

Speaker 4

And we believe that the combination of avalsitub with a PD-one inhibitor has the potential to become the standard of care for these patients. On to our CABOR-two ADC, ozarytomed clinical profile that is emerging in multi refractory heavily pretreated head and neck cancer. The worldwide prevalence and mortality rate for this population are significant and despite recent advances, there remains a profound unmet need, particularly for patients who have progressed on first line treatment options. Therapies available for these refractory patients are limited and have suboptimal clinical benefit. The current worldwide therapeutic market size of head and neck cancer is approximately $3,500,000,000 annually and is expected to grow significantly to nearly $5,000,000,000 over the next 5 years.

Speaker 4

Given the encouraging emerging data set in head and neck cancer, we believe ozariktumab vedotin could represent a significant commercial opportunity for Bio Atlas. We also believe ozaryptomab vedotin is well positioned for a strategic collaboration that will expand the potential of this CAB ADC across multiple solid tumor indications. Given the combined prevalence of head and neck cancer and BRAF mutated melanoma, we believe these assets and indications represent potentially meaningful value creating opportunities for Bio Atlas with the potential to redefine standard of care for patients with these devastating diseases. With that, I would now like to turn the call back over to Jay.

Speaker 2

Thank you, Sherry. Next, a few words in our potentially first in class dual cabbispecific T cell engager antibody, cabepcam, cabcd3. Epcam is a ubiquitous target expressed on the surface of cancer cells, which requires the use of our CAB technology to achieve optimal selectivity and safety. We are on track to report the full data set from the Phase 1 study in the second half of this year with a potential Phase 2 study initiating also in the second half of this year. The T cell engager space offers tremendous opportunity for more effective therapies and in particular, our CAB enabled EpCAM 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.

Speaker 2

BioAtlas has developed a novel next gen carbohydrate linker system to further reduce the potential risks associated with neutropenia from off target toxicity used in our cabnectin-four ADC. This ADC has the potential for broad applicability including for new indications such as pancreatic cancer. We recently presented compelling anti tumor activity, PK and toxicology data last month at the AACR Annual Meeting that indicate CABNectin-four ADC is potentially a more effective treatment with reduced toxicity. As part of today's update, we have received FDA IND clearance for this agent and are evaluating several options as we continue to focus our resources on our later stage clinical programs. With that, I would now like to turn the call over to Rick to review the Q1 2024 financials.

Speaker 2

Rick?

Speaker 5

Thank you, Jay. Research and development expenses were $18,900,000 for the quarter ended March 31, 2024 compared to 21,700,000 dollars for the same quarter in 2023. The decrease of $2,800,000 was primarily due to completion of preclinical development related to our Nekten-four IND and prioritization of our clinical programs in 2023. We expect our R and D expenses to continue to decrease in the near term due to recently completed enrollment in clinical trials for datasets expected to enable potentially registrational trials for our ADC programs. General and administrative expenses were $5,600,000 for the quarter ended March 31, 2024, compared to $7,200,000 for the same quarter in 2023.

Speaker 5

The $1,600,000 decrease was primarily due to lower stock based compensation and professional fees. Net loss for the quarter ended March 31, 2020 4 was $23,200,000 compared to a net loss of $27,400,000 for the same quarter in 2023. Cash and cash equivalents as of March 31, 2024 for $80,600,000 compared to $111,500,000 as of December 31, 2023. Net cash used in operating activities for the quarter ended March 31, 2024 was $30,800,000 compared to net cash used in operating activities of $22,700,000 for the same period in 2023. Our cash used for the quarter ended March 31, 2024 included approximately $5,000,000 in annual payments that typically occur during our 1st fiscal quarter.

Speaker 5

We expect our operating cash burn to be approximately $20,000,000 for the quarter ending June 30, 2024 and to continue to decrease in the second half of the year as we complete treatments in our ADC clinical trials, 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. We are pleased with the considerable progress we have made to date and our cumulative results across our CAB pipeline targeting solid tumors. We look forward to the multiple important milestones this year, including several planned meetings with the FDA to discuss our potentially registrational trial with VAR2 in head and neck cancer, guidance on the remaining portion of the registration trial in UPS with Axle and guidance for a potentially registrational trial with CTLA-four in BRAF mutated melanoma. With that, we will turn it back to our operator to take your questions.

Operator

Thank you. We'll now be conducting a question and answer session. Our first question is from Brian Chiang with JPMorgan.

Speaker 6

Can you elaborate on the duration of the confirmed response that you're seeing with your ROL-two ADC in head and neck today? And what is your expectation on the duration of response as the data set mature?

Speaker 2

Thanks, Brian. I'll let Eric take a crack at this one. Thank you.

Speaker 3

Thanks, Brian. So we definitely need further follow-up to estimate our duration of response, but I will refer you to Slide 29 of our updated corporate deck. The swimmer's plot gives you a sense of the confirmed responses and addresses the question you asked, particularly the patients that were treated at the every other week dosing. I will note that those patients were dosed first and then after completing that effort, we then went on to employ the days 1 and 8 regimen. So we have a bit longer follow-up for the patients in blue on Slide 29.

Speaker 2

And I'll just add, there are 8 patients still on treatment and that are ongoing of which 2 have responses that could confirm and there's also 2 with a decreasing tumor volume. Great.

Speaker 6

And then maybe can you help us also frame the expectation of response level and also the duration of response with the current standard of care in hand and neck today in second line and also third line?

Speaker 2

So I think when you look at the later lines, we're thinking if you could get 4 months plus on these keep in mind, we're 4th line here, 3 prior line median 3 prior lines. So this is really out there. The bar is exceptionally low, especially when you look at second line where you're getting on from a response rate standpoint, 13% on average. And so there you would like to see, I think 5 months plus, obviously go to first line, you'd like to see half a year plus. But I think given the late lines we're in, I think that it's encouraging.

Speaker 6

Great. Thank you so much.

Operator

Thank you. Our next question is from Kelly Hsieh with Jefferies. Please proceed with your question.

Speaker 7

Hi, everyone. Thank you for taking our question. This is Dave on for Kelly Hsieh and congratulations on the progress. I have a couple of questions on AXL. Can you provide any color on median follow-up that you might need before you meet with the FDA in second half?

Speaker 7

And also do you expect to start the next stage of recruiting in 2024 or it could be in early 2025? Thank you.

Speaker 2

Thank you. Yes, we're because we've completed the dosing that we intended for the first portion of the potentially registrational trial, our main goal here is to achieve multiple scans for each of those patients, which we think should readily occur in the second half of this year. And so our current thinking, assuming we got encouraging continue to get encouraging data that we would have an opportunity to start that next portion of the remaining portion of the registrational trial in late 2024.

Speaker 7

And one more on non small cell lung cancer randomized Phase III trial. Can you remind whether you started those trials in second line or third line? Or do you need any more alignment with the FDA?

Speaker 2

Well, on the non small cell lung cancer, if I recall correctly, median of 3 prior lines there. So it was pretty late, very refractory patients. And we reported that out in December of last year. And we've done an extension to that study to look at the target agnostic patients. So we'll give have that data in still later this quarter and we're going to pick an appropriate way to communicate that data once we get to the end of this quarter.

Speaker 2

And so and then I think from there, I think we've already got feedback from the FDA on how to to lay out this final strategy for that either independently or with partners.

Speaker 7

Okay. Thank you. Thanks for taking our question.

Operator

Thank you. Our next question is from Kaveri Polman with BTIG. Please proceed with your question.

Speaker 8

Great. Good evening. Congrats on the progress and thanks for taking my questions. For ROR-two ADC in head and neck, can you tell us what feedback you received from physicians on this data? And were there any patients who had seen any other widowed in ADC as prior line of therapy, whether it's PADCEV or TIV DAC?

Speaker 8

Also, how you're thinking about the competitive landscape in general?

Speaker 3

Thanks, Kaveri. It's Eric answering. So first, your question about the feedback we've gotten from physicians. I'll just give you some anecdotes. We received a call from the PI at USC indicating how pleased he was to report a complete response.

Speaker 3

And that's now confirmed and enabling the patient to go back to work. And that's a patient that we review in our corporate deck. We were also pleased to hear from Memorial Sloan Kettering where 2 of the investigators spoke about several patients on treatment, particularly emphasizing the tolerability and the rapidity of response. They felt that it really was serving an unmet need in this second, third and fourth line head and neck cancer, which is exceptionally challenging and so many patients having clinical progression, as they're getting these therapies. And then you asked the question about did prior treatment with one of the other orastatin based ADCs.

Speaker 3

When I look through the prior treatments, all patients had received a PD-one blocking agent, many received either a platinum or and or a taxine regimen. I didn't see any anecdotes of people that had received prior ADCs, but it's certainly an interesting question with regard to studies that are ongoing.

Speaker 4

Yes. Thank you, Barry. This is Sherry. I can take the question on the competitive landscape. Obviously, within the existing competitive landscape, there remains a profound unmet need in patients who fail frontline options.

Speaker 4

As you know, in second line, cetuximab is often used with an ORR of 13%. So we think within the existing therapeutic landscape that there remains an unmet need. And even if you look at the future competitive landscape, we have a different mechanism of action than those that are in development. And we think that the profile that's emerging in this very heavily pretreated patient population really provides the opportunity for us to benefit patients in the second line setting within the existing as well as future competitive landscape.

Speaker 8

Got it. That's very helpful. And maybe a question on the dosing regimen. I guess this is for both ACTL and ROE-two ADC. You tested different regimens from your initial schedule of Q2W to Q3W.

Speaker 8

Is this just for Project Optimus? Can you tell us what has been learned regarding the profile of the drug from these studies, whether you saw any significant PKPD differences with these regimen and how you are thinking about dosing schedule going forward?

Speaker 2

I'll just start off by saying I'll let Eric finish this, but I just want to say, I'll remind us all that we did use the 2Q3W in Phase 1. So it's not that news, certainly what we've looked at. But with respect to 2Q3W certain characteristics, I'll let Eric add to this. Sure.

Speaker 3

Thanks, Jay. So I'll emphasize that both of the regimens, I think are exceptionally well tolerated. I'll refer everyone to Slide 35 of our corporate deck, where we've summarized the every other week dosing, the 2Q3W, which is days 1 8 of a 3 week cycle and then for melanoma as well. And in here, we're having very few instances of related AEs leading to treatment discontinuation. And so tolerability is excellent with both regimens.

Speaker 3

We are seeing in the head and neck data in particular, I think you can see from the spider plot on Slide 28, just a sense that we get more rapid disease control in the red, which is the more intensive regimen than the blue. And it is interesting with the blue patients, they did have longer exposure, because we did that those patients first. And there are quite a few patients there are the 2 instances of patients that are at many, many weeks of therapy, 1 passing 35 weeks and one passing 45 weeks on study. So I think both regimens well tolerated and the PKPD, no surprises there. So, looking good.

Speaker 8

That's helpful. Thanks for taking my questions.

Operator

Thank you. Our next question is from Arthur He with H. C. Wainwright. Please proceed with your question.

Speaker 9

Hey, Jay and team. Good afternoon. Thanks for taking my question and congrats on the data in the head and neck. I just had a couple of questions for the head and neck data. So first, so I recall you mentioned you want to go for a first line for these RO2 ADC.

Speaker 9

First, I just want to get gauging your priority here for the future or still depending on the discussion with the FDA in the second half?

Speaker 3

Thank you, Arthur. I appreciate it. We haven't made a formal decision about whether we're going to target 1st or second or both yet. Our vision is that we'd like to go to the agency and discuss trial designs for both. For the first line, I think that the vorastatin based ADCs pair remarkably well with PD-one blockade.

Speaker 3

And so I think it'd be a really an excellent combination with PD-one antibody in the first line patients that receive just the PD-one antibody alone. And then we could of course do a Phase 1 evaluation in combination with platinum PD-one to further enable that. Moving to second and beyond, 2nd and beyond line, there's an enormous unmet need and we see a relatively straightforward trial design where we would compare either against cetuximab monotherapy or potentially a limited number of chemotherapy or cetuximab choices for the investigator with a PFS endpoint that might possibly enable an early review of the trial data and accelerated approval and then with an OS endpoint that would confirm in the same trial. So these are the possibilities that we are looking forward to exploring with the agency.

Speaker 9

Thanks, Eric. That was very helpful. And regarding the data, it seemed like the 2Q3W has a better response compared to the Q2W. And I'm just curious, is looking into the HPV expression marker in these patients, is there any correlation in the regarding the response rate of with the HPV expression there?

Speaker 3

Yes, it's a great question, Arthur. We have not seen a correlation with HPV expression. It's something that we're going to continue to look at very closely. Those patients receive therapy that's a little bit different. There's some recent data suggesting they can deescalate the aggressive early therapy.

Speaker 3

And so we've been guided by our investigators to think of them as a little bit different than the HPV negative population. But right now, not seeing any obvious correlations. And I'll just add that we're also not seeing obvious correlations with the ROR2 expression, because that's often a question that people ask us. And so we're not needing a companion diagnostic at this time.

Speaker 9

Got you. And if I may, for the CTLA-four program, for the upcoming data for the monotherapy in this quarter. Could you give us a little bit more color on the cancer type for those 20 patients as well as of now, what's the medium cycle number of patients received the drug?

Speaker 3

Okay. So moving to the conditionally binding CTLA-four and you're asking about the monotherapy. We open the doors very wide to melanomas and relapsed refractory carcinomas. So I would anticipate a very broad number of different one single patients with different unusual cancer diagnoses that sometimes weren't eligible for other clinical trials that were participating in the monotherapy experience. Our overall goal with the monotherapy was to clearly characterize the safety profile at both 350 milligrams and 700 milligrams.

Speaker 3

And I'm also happy to say that today we treated the 3rd patient at the 1 gram dosing level. So we've now infused all 3 of the individuals at the very high dose level of 1 gram, which is 14.2 milligrams per kilogram based on a 70 kilo adult. So we're looking forward to the ASCO presentation on June 1 and then a subsequent presentation to describe the outcome of these monotherapy patients that you've just asked about.

Speaker 9

Great. Thanks, Eric. Thanks for taking my question.

Operator

Thank you. Our next question is from Tony Butler with EF Hutton. Please proceed with your question.

Speaker 10

Yes. Thanks very much. I'd like to

Speaker 2

go back to the previous question, if

Speaker 10

I may. And Part A, again, this is with CTLA-four. Will there be or do you anticipate, I assume you will, that the combination with pembro at 1 gram will have been sufficiently have sufficient duration or you make a decision about moving forward in the BRAF mutated melanoma study, that's part 1. And part 2 of that is apparently from the comparator arm, you're making some judgments that there may be other types of agents that could be utilized other than pembro. And I'm just curious, does this end up simply being physicians choice in frontline?

Speaker 10

And then I have one more follow-up, if I may. Thank you.

Speaker 3

So, why don't I take these in sequence? So the very first question you asked is, will we have sufficient follow-up? And we believe we will. So I want to affirm that we are currently dosing patients with newly diagnosed melanoma, metastatic or unresectable melanoma and presently without regard to BRAF mutation to gain additional experience at this dose level. So these are first line patients.

Speaker 3

I just want to emphasize that because that is then going to then lead into the proposed pivotal trial. Your second question is a really interesting one and I think that agency feedback will be necessary here. I want to remind everyone that there are 4 strategies that could be employed for newly diagnosed metastatic or unresectable melanoma and they include nivolumab, pembrolizumab, both of those as monotherapy, Opduleg or the combination of nivolumab plus ipilimumab. And so our vision presently is that we'd like to run a blinded randomized study against Pembrolizumab because it represents a currently labeled opportunity and it's notable that several other sponsors are using pembrolizumab monotherapy as the comparator arm in their frontline melanoma trials.

Speaker 10

Eric, thank you for the follow-up or the commentary. My follow-up question is on the Nekton-four ADC with the carbohydrate linker. Just mechanistically, does the carbohydrate linker limit the number of the payload that you can actually add to the antibody? And if you say no, that's fine. But the question is, what is the DAR today?

Speaker 10

Is that the most optimal payload for the mexin-four ADC? Thanks very much.

Speaker 2

I'll take that one, Tony. Basically, the actual design of our carbohydrate linker system allows us to increase above the DAR4. So actually, our current, Nectin-four ADC is DAR6. And we've seen a very good safety profile. We think it's going to add to the safety profile because it's going to help us to reduce off target tox.

Speaker 2

In addition, it's also a cab, so further reduces on target tox. So we're really bringing these two pieces together. And in a very specific way because Nekton-four, the marketed compound is known to have various toxicities and one of those is significant as a rash. And so we at least from the animal data and from modeling, suggest that we have a therapeutic index that should allow us to be able to reduce, if not totally eliminate the rash and we'll just have to see the data further. We're kind of we're excited about this drug because we've also noticed that we've been enable had the ability to enable additional targets not traditionally associated with NECTAN-four activity and one of those is pancreatic cancer.

Speaker 2

And we do know that this observation is linked in part to our carbohydrate linker and the cab and carbohydrate linker working together. However, in saying all of this, I want to emphasize that there's no way I think is saying that the carbohydrate linker is better than what we've seen at the peptide linker in axel in war 2 because we don't we had a very specific toxicity to resolve Anectin-four. We are seeing very safe profile without those kind of toxicities with our axillary or 2 drugs. So I think in a way we came in to this program with a very specific purpose to address a very clearly defined toxicity. And so in combination, you have a chance here to go into indication with a very low bar with safety that could potentially allow this drug to go quite wide.

Speaker 2

And I'll just add, I think one nice thing about it is that you should get these results very quickly because there's a known level of dosing. And so with Phase 1, you should learn both your safety and your efficacy adequate to really validate this compound. So an exciting asset.

Speaker 10

Jay, it's fantastic. Thanks very much.

Operator

Thank you. There are no further questions at this time. I'd like to hand the floor back over to Jay Short, CEO for closing comments.

Speaker 2

Thank you everyone for your attendance today and continued interest in BioElo. We're obviously very encouraged by our data and very hopeful and a lot of drugs that I think are on the press of being able to bring to market. So hopefully it continues and thank you for your attention.

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

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