Q2 2022 Bioatla Inc Earnings Call
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Hello and welcome to the BioAlta Second Quarter 2022 earnings call.
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After today's presentation there will be an opportunity to ask questions.
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I now would like to turn the conference over to your host today, Bruce McElmichael. Hey Michael, please go ahead.
Thank you, operator, and good afternoon, everyone. With me today on the phone from BioATLA are Dr. Jay Short, Chairman, CEO , and Co-Founder, Scott Smith, President, Felipe Martin, Chief of Clinical Development and Operations, and Dr. Jay Short, Chairman, CEO , and Co-Founder, Scott Smith, Chairman, Chief of Clinical Development and Operations,
Sherry Lydick, Senior Vice President, Commercial Strategy, and Richard Waldron, Chief Financial Officer.
Earlier this afternoon, BioAtlet released financial results and a business update for the quarter ended June 30, 2022.
A copy of the press release is 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, financial and operating performance and expectations, operating costs and expenses, product pipeline, clinical trial and regulatory timing, and associated resource requirements.
its programs and potential partnerships, and the advancement of its CAB technology and product candidates.
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 10Q.
you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 9th, 2022, and Bio-Atwood 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?
Thank you, Bruce. Thanks to everyone for joining us for our second quarter 2022 BioATLA earnings call. The broad applicability of BioATLA's CAP technology has allowed us to continue advancing the development of our innovative clinical and preclinical programs.
The second quarter was marked by strong execution with promising results across five potentially registration enabling ongoing Phase II trials for our two latest stage CAB ADC product candidates, ncbodimab, the DOTIN, or VA3011, and azurifdomab, the DOTIN, or VA3021, across multiple solid tumor types for these first-in-class therapeutic candidates. Before I go any further, I'd like to remind everyone that additional details related to what we are doing.
into part two of that study.
Further, on today's call, we will discuss new results for additional sarcoma septides.
important initial interim data for the non-small cell lung cancer study for VA3011.
Our Phase 2 BA3021 studies also continued to advance and we anticipated an interim update for non-small cell lung cancer in the fourth quarter.
We also expected our successful validation of the liquid biopsy will accelerate the melanoma study for enrollment update later this year.
In addition, we are actively screening in our head and neck study with the first patient anticipated to be dosed shortly. Our phase 1, 2 basket trial for our CAHBS CTLA-4 antibody, DA3071, is currently ongoing with the first patient dose completed.
We also remain on track for our pre-IND meeting and IND filing for our dual-cab bispecific antibody, EPCAM CD3 or BA3182 this year.
We are pleased with our cumulative results that continue to support both the efficacy and safety from our differentiated proprietary CAD platform thus far in 2022. And I believe we are well positioned to continue with strong execution.
Most importantly, we are excited to share the updates of our ongoing clinical programs with you today, in particular, observations from our Phase II non-small cell lung cancer study with our lead SFBA 3011.
With that, I would now like to turn the call over to Felipe for additional details. Felipe?
Thank you, Jay, and good afternoon, everyone. I would like to provide initial interim observations on Part 1 of our Phase 2 study in non-small cell lung cancer and an update on Part 1 of our Phase 2 study in Sacramento.
First, I will go over our preliminary data in non-proxylon cancer and start with a brief introduction of the study design.
Our ongoing, potentially registration enabling phase 2 trial of BA3011 is designed to evaluate the efficacy and safety of BA3011, monotherapy, and in combination with nivolumab in axial expressing patients with refractory non-small cell lung cancer that have failed either ALK, eGFR, or PD-1 inhibitors.
We do not restrict the number of prior lines of therapy or restrict any particular type of non-small cell lung cancer and have enrolled patients with either non-squamous or squamous cell carcinoma. We do not restrict the number of prior lines of therapy or restrict any particular type of non-small cell lung cancer and have enrolled patients with either non-squamous or squamous
Therefore, the interim data will be presented accordingly.
There are two parts to the non-smol cell lung cancer phase two portion of the trial. In part one, interim analysis will be conducted after 20 and up to 40 patients, at the potential to be followed for at least three months.
Our predefined goal criteria for the interim analysis is to achieve a overall response rate of approximately 20%.
As of a data cutoff of July 15, 2022, we have enrolled 15 patients with nine efficacy-variable patients.
Four patients are currently on treatment but did not have yet the opportunity to be followed for three months and two additional patients were not deemed efficacy variable.
Importantly, all patients are PD-1 failure patients and have failed on average 2.5 cryolines of systemic therapy from metastatic disease.
Of the 90 valuable patients, seven were non-squamous adenocarcinoma patients, and two were squamous cell adenocarcinoma patients.
So far, we observed a total of one complete response and two partial responses for a combined objective response rate of 33%.
All responses were observed in non-squamous groups representing an OR of 43%, or 3 out of 7 patients. All responses were observed in non-squamous groups representing an OR of 43%, or 3 out
Four out of seven of these non-square-mesh patients were administered BA3011 monotherapy, while three received BA3011 in combination with nivolumab.
The two PRs were observed in the non-scramblous monotherapy group.
We're presenting an OR of 50% for this group.
and the CR was observed in the non-squared miscombination group representing an ORR of 33% for these groups.
Of the two available patients in the SqS cohort, we have not yet observed a response with either BH3011 monotherapy or BH3011 monotherapy.
Please go on one in combination with the voting that
All patients in the world were axial positive, with a TMPS of 1% or more. The rate of axial positivity in the non-small cell lung cancer population continues to be high. We estimate it to be approximately 35% for the non-squamous population, and approximately 30% for the squamous population, based on over 200 non-small cell lung cancer patients tested so far for axial expression.
As of the latest safety data cutoff, the safety and tolerability profiles from the Phase II non-small cell lung cancer study
continues to be differentiated from other MME ADCs.
No new signals have been identified from phase one, no treatment related deaths, and very few grade 3-4 AEs were reported.
To put this data into perspective and notwithstanding the predominant nature and small sample size of our dataset, the efficacy observed in this study and in particular the efficacy observed for the DH3011 monotopy non-squamous.
NBA3011 monotherapy, non-Squamers, and Squamers combined, is so far highly competitive in this PD-1 refractory population and supportive of moving forward to the registrational part of this study.
We are continuing to enroll patients in part one to help us better define which population and which treatment cohort we will be advancing to the registrational part of the study.
We're now close to 20 patients enrolled in the part one of the study. We anticipate we'll be able to present interim results of approximately 20 patients in the fourth quarter of this year.
I will now present the sarcoma data. During our last quarterly call, we presented interim data from our ongoing part one of the Potentially Registration Enabling Phase II trial of BA3011, which was designed to evaluate the efficacy and safety of BA3011 in adult and adolescent patients with a factory soft tissue and bone sarcoma.
with an old patient across seven different sarcoma subtypes to receive VA03011 monotherapy, and across all sarcoma subtypes to receive VA3011 in combination with eVolumab.
equally between CD20 positive and CD20 negative tumor expression.
The purpose of part one was to identify sarcoma subtypes that do not respond to BA3011 treatment and eliminate the subtypes from moving forward into part two of the study.
We define go, no-go criteria for the interim analysis.
Determine which subtype may advance to part two of the study. The threshold for a goal decision is either at least one partial response or complete response for subtype or progression free survival or PFS rate of at least 40% at pre-month.
Patients were selected based on actual expression using a TMPs of greater than or equal to 50% in each sarcoma subtype.
Subtypes in soft tissue sarcoma include leiomyosarcoma, echinomial sarcoma, liposarcoma, or the soft tissue sarcoma such as UPS.
In bone sarcoma, these subtypes included osteosarcoma, Ewing sarcoma, and other bone sarcoma, which includes chordoma and condorsarcoma.
The interim results presented previously in UPS and OTSACOMA satisfied our predefined goal criteria into part two of the phase two.
VA3011 study. UPS and OTSACOM are advancing a separate cohort to registration study.
Additional details for these registration studies will become available following FDA 16 response.
Today we are sharing data from additional cohorts based on an efficacy data cut-off of July 26, 2022.
In post-acoma, we've enrolled six patients and observed a PFS rate of 60%.
which exceeded our predefined goal criteria.
to part two of phase two. These patients have progressed on two or more of our lines of systemic therapy.
For context
Recent studies have shown that for the earlier first and second line with aesthetic in post-accoma patients the PFS rate for placebo at three months is around 30%.
and approximately 50% for ribonuclein atrobectidin.
In synovial sarcoma, we remove five patients.
distinctions that progress on three or more lines of systemic therapy.
The PFS rate at three months was 50% which also exceeded our predefined goal criteria to part 2 of phase 2
For context, the PFS rate for pazopanib at three months is 49% for the earlier first and second line with aesthetic synovial patients.
With regards to safety profile across sarcoma subtypes, BA3011 continues to be generally safe and well-tolerated with a Phase II safety profile consistent with the profile observed in Phase I.
We are currently evaluating the clinical and commercial opportunities for these subtypes.
and we'll decide on the path forward in the near future.
We are continuing to enroll patients in the Ewing sarcoma cohort and the bone other sarcoma cohort mostly made of chordoma and chondrosarcoma.
Thank you for your attention.
We will now highlight the significant unmet need and commercial opportunity in non-small cell lung cancer. Sherry? Sorry, I missed one more.
Thank you, Philippe, and good afternoon, everyone.
Lung cancer is the second most common cancer and the leading cause of cancer-related mortality worldwide, with 80 to 85% classified as non-small cell lung cancer. Upon further breakdown, non-scramus subtype accounts for approximately 75%, while squamous cell accounts for the remaining 25% of non-small cell lung cancer cases. There are over 540,000 people in the US living with lung cancer and approximately 2.5 million
in patients with metastatic disease.
Despite advances in first-line care, the majority of patients eventually progress and experience worsening outcomes after each line of subsequent therapy.
There are limited options for these patients who progress on immune checkpoint inhibitors, and available treatments in the second line setting and beyond have sub-optimal overall objective response rates of 10-20%.
While the data Felipe just shared are early observations, the signal is encouraging, particularly when we think about this multi-refractory non-small cell lung cancer population. And we believe that BA3011 has the potential to fill a significant unmet medical need for these patients. Thank you
Turning to the commercial opportunity, non-small cell lung cancer is one of the largest oncology therapy markets, valued at approximately $20 billion in 2020 in major markets and projected to grow 9% annually, reaching $48 billion by 2030.
We estimate that there are approximately 40,000 to 50,000 axial positive non-small cell lung cancer patients per year in the US and over 100,000 per year worldwide.
We estimate that this represents a significant global commercial opportunity of approximately $2.5 to $3 billion.
With respect to sarcoma, we remain energized about the continued opportunity for BA3011 in soft tissue and primary bone sarcomas, even when considering only UPS and osteosarcoma, given the significant unmet medical need and lack of approved treatments for these patients.
Combined, there are approximately 5,000 to 7,000 axial positive addressable UPS and osteosarcoma patients per year in the U.S., and over 12,000 globally, which we estimate to be a worldwide commercial opportunity of up to a billion dollars.
Taken together, our preliminary observations in non-small cell lung cancer and our phase 2 sarcoma study data, our lead CAB ADC asset BA3011 has the potential to be a best-in-class therapeutic treatment for patients who have failed frontline regimens with an estimated total global commercial opportunity of approximately $4 billion.
We are excited for the upcoming near-term catalyst this year in our BA3011 program.
and for the potential of this asset to fill significant unmet needs.
for refractory patients across a variety of cancers.
Now I would like to turn the call over to Scott Smith, President of BioATLA, to provide an overview and updates to other ongoing clinical programs. Scott? I'm Scott Smith, President of BioATLA, and I'm here to provide an overview and updates
Thank you, Sherry, and good afternoon, everyone. Before I review our key operational updates from the quarter, I want to share my excitement around the preliminary observations from part one of our phase two non-small-tile lung study.
Given the significant unmet medical need and commercial opportunity in refractory non-small cell lung, we are very excited to see an early signal in the non-Slimus population, albeit with a small number of invaluable patients today.
Plenary observations in a non-squamous cohort validate the signal observed from our phase one study.
We will wait for the full interim data analysis before making detailed study determinations, but we are thrilled to see a trend in a positive direction thus far with 3011 in this initial cohort.
The early observations in part one of our phase two non-small cell line study exceed our internal predefined go-no criteria.
And we will begin preparations for discussions with the FDA for part two of the study.
In the interim, we will continue to enroll and dose patients in both subtypes and anticipate a full interim dataset of approximately 20 patients.
through multiple scans in the fourth quarter of this year.
Additionally, the non-small cell lung phase two preliminary observations further strengthen 3011 as a potential best in class therapeutic treatment for a variety of cancers given the clinical outcomes from our other studies in sarcoma.
As reported last quarter, the interim phase 2 analysis at 3 months in axial positive sarcomas demonstrated meaningful anti-tumor activity and we met our predefined GO criteria for two very important sarcoma subtypes.
UPS and osteosarcoma. As discussed earlier, we are very pleased to note that two additional cohorts, liposarcoma and synovial sarcoma, now qualify to move to part two of the study based on our predefined criteria. We are currently evaluating the clinical and commercial opportunities for these subtypes and will decide on the path forward in the near future.
With respect to UPS and osteosarcoma, we have submitted a request to the FDA for written feedback regarding a study designed to support registration.
For UPS, we have proposed a single arm trial with ORR as the primary endpoint and a sample size of approximately 60 patients.
For osteosarcoma, we have proposed a double-blind randomized placebo-controlled trial with PFS as the primary endpoint in a sample size of approximately 120 patients.
We anticipate written feedback in the coming weeks and will begin enrollment shortly thereafter.
Now turning to our second lead Cab 8AC product candidate, BH3021.
Cab War 2 ABC.
As a reminder, there are no other therapies targeting war two in the clinic, so we have the potential to have a first in class treatment for solid tumors.
In phase one, we saw impressive responses in war two positive patients refractory to PD-1 therapy, including two PRs in non-small cell lung, one PR in head and neck cancer, and a complete response in a melanoma patient who remains in complete remission off treatment for over two years. In phase one, we saw impressive results in a melanoma patient who remains in complete
To date, we have three phase two trials ongoing with 3021, and I'm happy to provide an update as to where we are with each beginning with non-small-sar long.
The non-small cell lung trial in refractory patients is enrolling as planned and currently dosing with an interim update of the preliminary cohort of up to 20 patients, followed by at least three months of therapy anticipated in the second half of this year.
Turning to the melanoma trial, which is being conducted in patients' refractory to PD-1 therapy. As previously discussed, we ran into challenges with trial recruitment.
which we believe was due to lower war 2 positivity rate than anticipated and challenges obtaining invasive tissue biopsies in these patients.
However, after working on a liquid biopsy with our partner, RareSite, we are happy to report that we now have a validated, non-invasive liquid biopsy assay.
that we are implementing this part of the study protocol this quarter.
As a reminder, we previously mentioned that when melanoma enrolled in the phase 2 as of last quarter achieved a complete response.
Together with the complete response we observed in one patient in phase one study, we have two out of two war II positive PD-1 refractory patients with a complete response, which is quite remarkable.
We remain very excited about the potential of 3021 in melanoma patients, particularly with potential acceleration of enrollment, following validation and implementation of the liquid biopsy.
The third phase two study that we've initiated with 3021 is in refractory patients with head and neck cancer and the first patient is anticipated to be dosed very soon.
To round out our CAB ADC programs, we are supporting a multi-center investigator-initiated Phase II clinical trial of 3-0-1-1 or 3-0-2-1 in patients with platinum-resistant ovarian cancer.
This trial is ongoing and to date five patients have been dosed.
Now I'd like to talk briefly about updates for our CAB CTLA-4 antibody, BA3071.
The phase 1-2 trial that will examine safety and tolerability of 3071 on model therapy and in combination with Nomolimab is ongoing and the first patient has been dosed.
We believe there's a tremendous unending and commercial opportunity for a safer and better tolerated CTLA-4.
Turning now to our preclinical pipeline, BioOutlet has several candidates in IND enabling phase that include cab-Biospecifics and second-generation ADC antibodies.
We will remain on track for a pre-IND meeting and IND filing for a CAB, FPM, CAB, CD3, body, specific antibody later this year.
as well as
but it was very gratifying for us to see two more cohorts in sarcoma qualify. I think showing the overall potential utility of this drug in the sarcoma space where there is really very little. Okay, thank you. Thank you for taking my question and talking to you guys. Thank you Arthur. Thank you. Next question, Konstantini Butler with Roth Capital. Yes, sorry, forgive me. Three specific questions if I may. One, they are all related to the 3011 in SCLC. The first is, correct me if I'm wrong, there was a scan at three months, correct? And then the next scan, what you're discussing would be at six months. So could you just talk about the cadence of scans? That's question one. Number two is, do you have information or could you share that information on time to response? Would you have an idea about that? The monotherapy and the combo, I just wondered if in fact the combo led to a time to response that was more rapid. And the third is, if you consider what duration one would like to see from a registration perspective, what might that be? Thanks very much. So thank you Tony for the questions and I'll give a sort of top line overview and I'll pass it to Felipe to go into some more detail with you.
would be as we've been? Oh yes, yes, so you answered six months which is what we've answered before. Data from others show that it could be as low as four months but we're going to shoot for six months.
And may I actually ask one follow up and it would be of patients that
I have not responded, but I assume are still being followed.
Are there any characteristics of those patients, be it
bulk of disease, I could think of others, that may be characteristic of those patients that did not respond. Thanks very much.
Well, certainly I will say, no, no, please just let me make a quick comment, Philippe, and then you can even, certainly, you know, in the end, we want to wait until we see the full 20 patient data set through, you know, multiple scans, but, you know, we saw responses in the non-Sloemus population and in the M-Sloemus population. So there's a clear differentiation, right? We had three responses, two parses in the complete and seven patients with non-Sloemus, which is, you know, a pretty remarkable response rate.
So that's one characteristic. I don't know, Philly, if you know or say anything else about the patient's where it would help predict the response. Please stay excited to see if you can tell we look at your excuse. Here's regret.... Here's regret coming out in the mouth of the patient as response.
No, so far we've had more patients that are all PG-1 carrier patients. I think generally speaking the number of prior lines of therapy usually is a factor in how well or how quickly a patient can respond to treatment. So we'll keep an eye on that. And all the patients we've been with so far were also all smokers or prior smokers or current smokers.
That generally is a negative factor for these patients, but they all had the same similar baseline when compared to smoking. So nothing extremely different from patient to patient.
Thank you, Philippe. Thank you, Scott.
Thank you.
Thank you. And this does conclude the question and answer session. I would like to return the floor to Scott Smith in closing comments.
No, I just would like to thank everybody for joining on the call. I think, you know, a quarter of real important progress for us on the non-small cell line, but also a lot of progress in sarcoma. We want to continue to accelerate the clinical programs and have more to report on as we get into the Q3 call. Just again, thank you all very much for listening. I'm very, very excited to continue these programs. Thank you.
and continuing to show the differentiation that we believe these cab assets can have in the clinic. Thank you all for your attention.
Thank you. The conference is now concluded.
Thank you for attending today's presentation. Now disconnect your lines.
Thank you.
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