BioAtla Q4 2024 Earnings Call Transcript

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March 27, 2025

There are 10 speakers on the call.

Operator

is now my pleasure to turn the conference over to Mr. Bruce Mackle of LifeSci Advisors. Please go ahead, sir.

Speaker 1

Thank you, operator, and good afternoon, everyone. With me today on the phone from BioAtla 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 in a short Q and A.

Speaker 1

Earlier this afternoon, BioAtLab released financial results and a business update for the fourth quarter and full year ended 12/31/2024. 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 and 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 K 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, 03/27/2025, 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 Doctor. Jay Short. Jay?

Speaker 2

Thank you, Bruce, and thanks to everyone for joining us for our fourth quarter and full year twenty twenty four BioLyla earnings call. Additional details related to what we will share today are available in today's press release and our updated company presentation, which are available on our website. Also, the posters, which were recently presented at the Mayo Multidisciplinary Head and Neck Cancer Symposium and the European Lung Cancer Congress on our Phase two assets, of zorifedumab vedotin or OSV and mecbutumab vedotin or MECV respectively are also available on our website. I will begin with updates on our conditionally active biologic or CAB platform clinical programs that we are advancing internally at Bio Atlas. All of these CAB based programs are designed to efficiently increase the potency and safety of our therapeutic candidates targeting solid tumors in areas of high unmet medical need.

Speaker 2

Beginning with our first in class dual conditionally binding CAB, EpCAM and CAB CD3 bispecific T cell engager antibody. EpCAM is an attractive therapeutic target because it is widely expressed in most solid tumors. However, it has been a difficult target to drug with traditional antibody technologies because it is also widely expressed in normal epithelial tissues. EpCAM's ubiquitous expression in both tumors and normal tissues makes it generally undruggable without a differentiating technology like cabs. Successfully enabling the selective targeting of solid tumors with cabs technology offers the potential for developing one of the first pan cancer therapies outside of immune checkpoint inhibitors.

Speaker 2

Today, our dose escalation is progressing well. As hoped the maximally tolerated dose has not yet been reached and multiple patients are already experiencing tumor reduction, including one colorectal cancer patient with continued stable disease for more than one year. At present, three patients have received the target dose of one hundred micrograms weekly. Two of these three patients have already cleared the dose limiting toxicity period and the third patient is on track to clear the DLT period on April 8. We are now also screening patients for the next cohorts who are anticipated to receive the target dose of three hundred micrograms.

Speaker 2

Details about the dosing schematic can be found in our corporate deck. It's worth noting that animal modeling data indicate that significant tumor reduction is expected to occur at target doses of approximately two hundred micrograms and above. So we believe that we are reaching exposures where we will start observing formal objective responses. We remain on track for a data readout of the dose escalation portion of the study in mid-twenty twenty five. We also anticipate a data readout for the cohort expansion portion of the study in the first half of twenty twenty six.

Speaker 2

CAB T cell engager bispecifics represent a novel approach to harnessing the body's immune system to target and destroy cancer cells, offering the promise of more precise and effective treatment options for cancer patients. We believe our dual cab Epchem and cab CD3 T cell engager has potential to be at the forefront of this exciting and powerful approach and has the potential to treat a wide range of metastatic tumors, including cancers of the colon, lung, breast, pancreas and prostate among others. Now moving on to cabaxel ADC MACV. Last quarter, we announced that we are observing ongoing anti tumor activity with multiple confirmed responses among twenty one evaluable patients with tumors expressing NK RAS across nine different KRAS mutations. As part of today's update, we are excited to share promising results from the one point eight mgkg Q2W dosing cohort.

Speaker 2

From the 16 evaluable patients in this cohort, we have observed multiple confirmed responses across different MK RAS variants, while also demonstrating an encouraging clinical benefit risk profile, as well as a patient who had a prior failure of sotorasib, who experienced a partial response. In addition, a patient who achieved a complete response remains in complete response now for over two years. Importantly, our initial findings for overall survival continue to be compelling as we are now seeing an exceptional overall survival with sixty six percent and fifty eight percent of patients with MK RAS non small cell lung cancer alive at a landmark of one year and two years respectively, which we believe exceeds what has been observed with the standard of care. The median overall survival has not been reached at thirty five months from the first dose with continued follow-up ongoing. BIKV is associated with a generally well tolerated safety profile, both with and without nivolumab and no new safety signals have been identified.

Speaker 2

Notably, the drug related treatment discontinuation rate was only seven percent. We are presenting these data at the European Lung Cancer Congress and encourage you to visit the poster on our website. Based on our evaluation of patients with mutant KRAS non small cell lung cancer, we continue to observe a high correlation of axel and MKRAS expression and believe the mechanistic link between axel and MKRAS that drives tumor resistance coupled with the exceptional overall survival that we are seeing in the Q2W dosing cohort supports a potential anti axial pan MKRAS strategy. Now I'd like to pivot to the Phase II clinical programs that we are currently advancing toward corporate partnerships. Beginning with our TAB102 ADC AUS V, which is being evaluated as a monotherapy and treatment refractory head and neck cancer patients.

Speaker 2

Last quarter, we reported an emerging clinical profile in treatment refractory patients with a median of three prior lines of therapy with the potential to become the standard of care in the second line plus head and neck cancer population. Additionally, we shared that we received a fast track designation and actionable guidance from the FDA on our proposed randomized pivotal trial design with OSV monotherapy versus investigators choice among patients with recurrent or metastatic head and neck cancer with disease progression on or after platinum based chemotherapy and PD-one antibody therapy. As part of today's update, the fully enrolled Phase two study using OBS V monotherapy continues to demonstrate new responses in treatment refractory second line plus head and neck cancer at the one point eight mgkg Q2W dosing regimen. We also continue to capture efficacy data for several endpoints, including overall response rate, duration of response, progression free survival and overall survival. A particular interest is that we have observed a compelling signal in patients with metastatic HPV positive head and neck cancer.

Speaker 2

Who represent a high unmet need as they are poorly served by agents that inhibit eGFR. These new data, as well as evolving data in the overall head and neck cancer cohort were presented as a poster today at the Mayo Multidisciplinary Head and Neck Cancer Symposium. To highlight among the eleven patients with HBV positive head and neck cancer treated with 1.8. There was a one hundred percent disease control rate, a forty five percent overall response rate and so far a twenty seven percent confirmed response rate with a duration of response greater than five point three months that is ongoing. Multiple patients remain on treatment and have the potential to have responses that deepen with time.

Speaker 2

It is noteworthy that an HPV positive patient achieved a complete response that continues in complete remission now at greater than sixteen months and ongoing. We believe OSB, especially at the one point eight mgs per kg Q2W dose has been remarkably well tolerated and there are no new identified safety findings. Further, these results of HPV positive head and neck cancer are mechanistically supported by recent literature showing that HPV associated oncogenes upregulate LOR2 expression, driving proliferation and invasiveness, thus now providing a compelling rationale for also targeting LOR2 in cancers associated with human papillomavirus infection. We believe our extended experience with Q2W dosing of OSV also has the potential to satisfy Project Optimus requirements and we plan to share our results with the FDA to seek confirmation regarding our proposed recommended Phase three treatment regimen. We are encouraged by the differentiated findings in second line plus head and neck cancer patients, particularly in both HPV negative and HPV positive patients.

Speaker 2

For partners, the second line plus population represents a worldwide commercial opportunity of greater than $1,000,000,000 in peak sales with upside opportunity in the first line setting, as well as in other HPV positive cancers. Moving now to our CAV C-twenty four antibody, Avastatrug. Avastatrug is similar to ipi with respect to epitope, affinity and half life. A difference from ipi with respect to its ability to avoid binding in the normal tissue environment. As part of today's update, we have dosed a total of twelve patients with unresectable and or metastatic melanoma, eight of whom received five mgs per kg, three were dose escalated to ten mgs per kg and one dose escalated all the way to fourteen point three mgs per kg.

Speaker 2

While we continue to observe compelling anti tumor activity with a differentiated safety profile, ten of the 11 evaluable patients showed tumor reduction and with the eleven showing no growth to date. Of these 11 evaluable patients with unresectable and or metastatic melanoma treated with a valsit drug in combination with the PD-one antibody, so far we observed across multiple doses an overall response rate of sixty four percent and disease control rate of one hundred percent. Notably, we observe a partial response in a patient with acral, subungal or under the fingernail melanoma, which is a rare and difficult to treat form of melanoma that generally has a poorer prognosis than continuous melanoma. The safety profile of avalsitug continues to be differentiated with a relatively low incidence and severity of immune mediated AEs, particularly among patients who receive five mits per kg for less than or equal to 18 in a total of seventeen patients. Focusing on these seventeen patients, we observed eighteen percent grade three immune mediated adverse events and no grade four events, while maintaining strong efficacy.

Speaker 2

The safety profile compares favorably to ipilimumab with a reported rate of forty percent grade three and four immune mediated adverse events. We believe avacitag has demonstrated a differentiated clinical profile relative to other CTLA-four antibodies and has the potential to be best in class. As such, we have recently initiated partnering discussions with the intent to align with a partner that can maximize the value of this asset. On to our ongoing clinical communications. I am pleased to report our progress with the medical and scientific communities as acknowledged with numerous publications and presentations at prestigious conferences, including the European Lung Cancer Congress, Mayo Multidisciplinary Head and Neck Symposium and the American Society of Clinical Oncology.

Speaker 2

Finally, for our corporate updates, BioAtl is further extending our runway beyond key clinical readouts in the first half of twenty twenty six by streamlining and realigning resources, which includes a workforce reduction of over 30%. We estimate that we will incur approximately $600,000 of one time cash payments related to the workforce reduction, which will mostly be paid in the second quarter. We intend to retain all employees essential for advancing our two internal priority programs, as well as supporting partnering of other clinical assets, which are improving with the ongoing data readouts. I also wish to express my deep appreciation and respect to our employees, both past and present, who have contributed so much with their creativity and hard work to advance these important cures for patients. With that, I would now like to turn the call over to Rick to review the fourth quarter and full year 2024 financials.

Speaker 2

Rick?

Speaker 3

Thank you, Jay. Research and development that is R and D expenses were $11,600,000 for the quarter ended 12/31/2024 compared to $22,700,000 for the same quarter in 2023. The decrease of $11,100,000 was due to lower clinical development expenses in 2024 from the prior from the lower overall targeted enrollment across our clinical trials in 2024 resulting from our program prioritization in 2023. We expect our R and D expenses to continue to decrease overall in the first half of twenty twenty five due to our recent restructuring and as we complete Phase II trials for several indications and focus our ongoing development on our prioritized programs. General and administrative expenses were $4,600,000 for the quarter ended 12/31/2024, compared to $5,900,000 for the same quarter in 2023.

Speaker 3

The $1,300,000 decrease was primarily due to lower stock based compensation, personnel related costs and D and O insurance premiums. Net loss for the quarter ended 12/31/2024 was $14,900,000 compared to a net loss of $26,900,000 for the same quarter in 2023. Net cash used in operating activities for the full year ended 12/31/2024 was $72,000,000 compared to net cash used in operating activities of $104,000,000 for the same period in 2023. Cash used for the quarter ended 12/31/2024 was $7,500,000 Cash and cash equivalents as of 12/31/2024 were $49,000,000 compared to $111,500,000 as of 12/31/2023. Excluding any potential future milestone, we believe that cost reductions to be subsequently realized from the realignment of Resolue and focus on our two internal priority programs further extends our runway beyond key clinical readouts in the first half of twenty twenty six.

Speaker 3

And now back to Jay.

Speaker 2

Thank you, Rick. We are encouraged by the clinical outcomes observed from our evolving CAB program datasets, which continue to be differentiated in some of the most challenging solid tumor types. As a result, we continue to advance multiple discussions with potential collaborators on our Phase II assets, as well as initiate new ones. We believe the compelling results we are obtaining will serve as important catalyst, including our EpCAM T cell engager program and have the potential to be transformative for our patients and shareholders alike. Thank you for your attention and continued support.

Speaker 2

With that, we will turn it back to the operator to take your questions.

Operator

Thank

Speaker 4

And we will go first

Operator

to Jeet Mukherjee of BTIG.

Speaker 5

Great. Thanks for taking the question. So just in terms of the partnered programs, I noticed in the corporate deck you had mentioned the ROAR2 program is in the process of partnering, while CTLA4 is initiating partnering. Could you perhaps just give a bit more color on where you are on these discussions and what's perhaps needed to get one or both across the finish line? Thank you.

Speaker 2

This is Jay. We have both advanced discussions and newer discussions. This HPV positive data is pretty new to most of the people we're in discussions with except for just a small number. So we also expect additional interest that prior to this report. So we're pretty encouraged with the discussions that are underway.

Speaker 2

And so I think it covers a range and I'm expecting some new participants to get involved as well, because I think this has been a significant problem in the treatment of head and neck cancer is being able to add in effective treatments in these refractory HBV positive patients.

Speaker 5

Understood. And maybe if I could just ask a follow-up for the ACTFL program. I believe last time you were still analyzing some patient samples for both ACTFL and KRAS expression. So in your hands, what percentage of patients are double positive for mutant KRAS and axel? And have any patients on the study to date been treated with a pan RAS inhibitor?

Speaker 5

Thank you.

Speaker 2

I'll share some of this question with Eric. I'll just start off by saying in our immunohistochemical analysis, we saw a bit over seventy percent that were positive across all types of MK RAS mutants. And I think the G12C was, I think, 100%. Also, we know that if you look at mRNA levels, that it's much, much higher than even that. So it's a very strong correlation, keeping in mind that mRNA is likely to be more sensitive than immunohistochemical data, but it's a very strong correlation and further there's a fundamental mechanistic alignment.

Speaker 2

You'll see if you look refer to the corporate deck, you'll see that laid out there on Slide 23 within that deck. Eric, you want to add anything to this?

Speaker 4

Sure. Thank you, Jay, and thanks for the question, Jeet. On Slide 24, we indicate that one of the patients had prior treatment with sotorasib and they did experience a response and we did not treat anyone with a known prior exposure to a pan KRAS inhibitor, which was your question. Thank

Speaker 2

you.

Operator

We will move next to Kelly Shi with Jefferies.

Speaker 6

Hi. This is Han Fei for Kelly. Thanks for taking my question. As your near term data coming up with BA3182, just curious what kind of data we're expecting? And have you reached a recommended Phase II dose?

Speaker 6

And what we're looking for in the next follow-up data and expansion portion of the study? Thank you.

Speaker 2

Eric, you want to take that one?

Speaker 4

Sure. Thank you, Kelly. I appreciate the question. On Slide 19 of our recently released corporate deck, we have the BA3182 dose escalation schema. So just to remind everyone, this is the EpCAM targeted T cell engager where it's conditionally binding both on the EpCAM arm and the CD3 T cell binding arm to really drive the therapeutic window even further to benefit.

Speaker 4

This gives you a sense of the dose escalation. We've achieved cohorts A1, B1 and B2 and then we're moving up with a one step priming dose and a two step priming dose. We're doing that concurrently and you can see there's a schema for cohorts C and D that are both enrolling concurrently. And you asked about the recommended Phase II dose. We think we're in a zone where we're seeing meaningful tumor control and as the animal model suggests that tumor reduction would occur right around two hundred micrograms given weekly, It's really consistent with that.

Speaker 4

So we're enthusiastic to be able to report more fully on this Phase one data set in the coming months. I'll note that two of the three patients in Cohort C4 as you see on the slide have already cleared the DLT observation window and the third patient will clear very shortly as Jay just mentioned in early April.

Operator

We'll move next to Ren Benjamin with Citizens.

Speaker 4

Hi. This is Sam on for Ren. Just a quick one on 3182 as well. Are there any partnership ongoing partnership discussions ongoing for this asset? And if so, are these contingent upon the mid-twenty five data?

Speaker 2

Sherry, you want to touch on that one?

Speaker 7

Sure, sure. Hi there. Thanks for the question. We currently have had interest in this program. Our goal is to get through Phase one and also the expansion cohorts so that we have a data set that can really drive a lot of value for this program.

Speaker 7

So while we've had interest, you know, we're not at a point where we necessarily would engage in discussions until we have a look at what the dose expansion, what the dose escalation and expansion data look like.

Speaker 2

Got it. Thank you for the color.

Operator

We will go next to Tony Butler with Rodman and Renshaw.

Speaker 8

Thanks very much. Eric, one question on the HPV positive patients for the head and neck cancer program, were all of those patients that responded smokers? That's actually somewhat important. And second, Jay, you had mentioned partnering program, but in the deck again, it makes reference to moving toward discussions with mid tier companies. And I just wonder what that why that strategy or is it in fact an argument such that the market opportunity may be somewhat smaller than the large pharma would engender and a mid tier company would like very much?

Speaker 8

Thank you.

Speaker 2

Why don't I start with the last one and then we'll go to the other one. We think that it's $1,000,000,000 opportunity over $1,000,000,000 in the second line. And so we did experience one larger company that indicated that they were wanting a multi billion dollar opportunity. Mid tier companies and that's really where that's derived from. But let's face it, a $1,000,000,000 opportunity in the refractory patient population with a fairly efficient trial and a big differential from others from the standard of care has is still pretty exciting.

Speaker 2

I would also note even in the HBV positive subpopulation, it's over 500,000,000.0 risk adjusted. So it's I think either way you cut it, it's pretty good and you still have the opportunity to advance to first line, have the opportunity to advance to other indications as well. So, but you're right in this regard, Tony, that we said we recognize that some adding in some of these mid tier players matters. And actually, I would say it does matter because we're seeing some people that have capital, but have really not been able to perform with their late line drugs and are very interested in getting into some strong Phase two compounds that can move to efficient Phase three. So hopefully that helps address some of it.

Speaker 2

It does. Thank you, Jack.

Speaker 4

Hey, Tony. So you have a really interesting question about smokers amongst the patients that have the P16 positive protein, the HPV analysis. We have a total of twenty six patients in this that had the HPV of forty total. And as you know, the HPV negative patients were really more associated with smoking and alcohol exposure, the environmental exposure form and HPV is much more the oncogene driven side with a particular unmet need amongst patients when they reach second and third line setting because the lack of eGFR benefit. And I don't have the smoking correlation set up, but that's something I can try to obtain for you after the call.

Speaker 4

So thank you.

Speaker 8

I appreciate that. The key is whether it's smokers and nonsmokers, that's really where I want to go with

Speaker 2

that HPV positive cohort. Thank you.

Speaker 4

Yes, we have the smoking data. It's just we haven't made a correlation with the HPV, but it's a great question and we'll get right on that.

Speaker 2

Thank you. Thank you.

Operator

We'll move next to Arthur He with H. C. Wainwright.

Speaker 9

Hey, good afternoon, Jay and team. Thanks for taking my question. So I guess I have three quick questions. So first for the FCAM program, regarding the data coming to mid this year, is that which kind of dose level of the data we can see? Can we go up to the three thousand three hundred milligram microgram, sorry, microgram cohort data or it's probably more at the lower dose levels?

Speaker 2

Well, certainly the three hundred we should have, assuming all the dosing goes well. Is there a chance to see nine hundred possibly if we do it in July? So we're still we'll just make sure it also depends a little bit on patient recruitment, but I'm very comfortable that the three hundred will be there and potentially higher.

Speaker 9

Got you. So Jay, when you're talking about three hundred, you mean three hundred from both C and D arms or

Speaker 2

just the C arms? No, I'm talking about C. I think the D formally is just behind the other, but tends to reinforce. But yes, I'm focused on C right at the moment.

Speaker 9

Got you. Thanks for that. And my second question is regarding the XL program. So maybe correct me if I was wrong. So are we going are you guys going to treat more patient for the in terms of the ASL program or I mean is there any more additional patient data we can see from in the future?

Speaker 2

I think our hope I mean, EpCAM is a priority right now because of many reasons and because of the safety that we're seeing, which we're liking and the broad applicability. I mean, it's a pan cancer drug and it's hard to ignore how big this could be. With Axlel though, we see some advantage of being able to do a few more patients on that. So our hope is to add in a few more patients. They haven't been added yet.

Speaker 2

We're in the process of amending our trial for to allow more patients. But we're going to have a pretty good picture of what happens on EpCAM. So our intent is to drive some additional patients there, but I will allow that EpCAM could turn into something so exciting that we made it decide to double down there. But for now, yes, that's our plan.

Speaker 9

Got you. Thanks for that. And then my last question is regarding the BD or strategic wise. So besides you think about to part out the IRR2 and the CTLA-four program, are you open to any other strategy to maximize the stock shareholder value?

Speaker 2

Oh, yes. I mean, we certainly would be open if a partner decided that they want to drive axle instead of Oortube. I mean, both are pretty exciting. We're also always looking at backup strategies. We're partnering timing sometimes as we've learned, it can be hard to exactly forecast, but we're definitely doing both of those things.

Speaker 9

Got you. Yes. Thanks for taking my question and congrats on the progress.

Speaker 2

I think they're coming in very nicely. I think it's kind of rare in this world where everything is working.

Speaker 9

Thank

Operator

you. It appears that we have no further questions at this time. I will now turn the program back over to Jay Short for any additional or closing remarks.

Speaker 2

I just want to thank you all for your time and I think hopefully you've heard some of this data. We're pretty excited about the differentiation we're seeing in the Ward two programs. EpCAM, we think we're pioneering there. We also think Axel is also as well as C24 are showing the differentiation that we expected from CAB and I think that's going to translate into partnerships sooner than later. So thank you for your time.

Operator

Thank you. This does conclude today's program. Thank you for your participation. You may disconnect at any time.

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