Q3 2023 BioAtla Inc Earnings Call
Good afternoon, ladies and gentlemen, and welcome to the bio <unk> third quarter 2023 earnings call. At this time all lines are in a listen only mode.
Following the presentation, we will conduct a question and answer session.
During this call do you require immediate assistance. Please press star zero pretty operator, please be advised that today's call is being recorded on Tuesday November seven 2023.
I would now like to turn the conference over it could really Smacker lifestyle advisors. Please go ahead.
Thank you operator, and good afternoon, everyone with me today on the phone from bio Ala Carte Doctor J shorts, Chairman CEO and co founder.
And Rick Waldron, Chief Financial Officer.
Following today's call Dr. Eric <unk>, Chief Medical Officer, and Sherry Lilac, Chief Commercial officer, who will join Jay and Rick for a short Q&A.
Earlier this afternoon bio outlet released financial results and business update for the third quarter ended September 32023, a copy of the press release and corporate presentation are available on the company's website.
Before we begin I would like to remind everyone that statements made during this conference call will include forward looking statements, including but not limited to statements regarding <unk> 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.
And expectations with respect to enrollment and dosing in its clinical trials plans and expectations regarding future data updates.
A nickel trials regulatory meetings and regulatory submissions.
Potential regulatory approval path for its product candidates and expectations about the sufficiency of its cash and cash equivalents plans to prioritize and focus development on selected assets and indications and.
And expected R&D and G&A expenses.
These statements are subject to various risks assumptions and uncertainties that can cause actual results to differ materially and are described in our 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 November seven 2023, and <unk> 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 and thanks to everyone for joining us for our third quarter 2023, <unk> earnings call.
As the inventor and leader in the development of novel therapies, using a proprietary conditionally active biologics cabs platform with improved selectivity for attacking tumor cells, while avoiding healthy cells, thereby addressing critical unmet needs in oncology to improve patients' lives.
As we approach the end of 2023, we have obtained data to support several value inflection points across our cap portfolio and continue to focus on further advancing the development of our prioritized programs.
We believe that forming one or more strategic collaborations with major pharmaceutical partners can accelerate development of selected assets.
And maximize their market opportunities.
We also believe that a more focused strategic approach better positions us to enhance value for shareholders.
Additional details related to what I'm going to provide are available in today's press release, and our revised company presentation, both of which are available on our website.
I will now provide some new updates since our second quarter call in August.
With our cab axle ADC B phase III zero.
Regarding <unk> three zero 11 phase II study in non small cell lung cancer, we have consistently observed multiple clinical responses in actual positive treatment refractory lung cancer populations.
Among patients receiving <unk> three zero 11, monotherapy, who previously experienced PD one treatment failure and were evaluable for efficacy at 12 weeks. The observed objective response rate was 27, 8%.
In patients with Egfr wild type non squamous lung cancer, who previously experienced PD one treatment failure.
Three 3% of the patients had a partial response to be a three zero 11 monotherapy.
Of note excellent suppression in lung cancer defines a particularly poor prognostic group.
So these patients had experienced a failure of a median of three prior lines of therapy. So we believe that observing multiple responses in this treatment refractory poor prognostic group is clinically meaningful and relevant.
In addition to the consistent differentiated safety profile, we continue to observe clinical benefit in patients, including multiple Prs <unk> score of 1%.
We are exploring the potential clinical benefits and actual <unk> negative patients, which is important for understanding the market potential of three zero 11th in lung cancer.
Earlier this quarter. We also received verbal FDA feedback that we believe are supportive of a registrational path forward for <unk> III zero 11 in lung cancer.
We anticipate receiving formal written feedback later this month.
To share more details and interim phase II data to be presented at the <unk> conference and our Kols that in early December.
Our phase two potentially Registrational study for undifferentiated pleomorphic sarcoma or UBS is ongoing and we continue to enroll the two Q3 W dosing regimen for up to 20 patients.
We have decided not to further advance the three Q4 W dosing regimen across any cohorts in either.
Three zero 11, or the VA three zero 21 studies due to sub optimal compliance with this dosing regimen, which is consistent with a lack of meaningful difference in the efficacy observed with Bas three zero 11.
While sarcoma.
Okay.
In regards to other bone and soft tissue sarcoma cohorts. We are pleased to have hit our internal go criteria for several sarcoma subtypes, including <unk> sarcoma, Lippo sarcoma and osteosarcoma.
As a reminder, our internal go criteria as defined as achieving greater than or equal to one complete response slash partial response or a progression free survival rate of greater than or equal to 40% at 12 weeks.
All cohorts are now completed and we plan to submit available data to a medical meeting in 2024.
As previously communicated our highest priority is to deliver innovative life changing therapies to cancer patients with significant unmet medical needs. We have now observed multiple clinical responses in several treatment refractory solid tumor populations with our Capex will ADC asset VA threes or 11.
We have also recently received feedback from the FDA.
Three zero 11 lung cancer Registrational study design.
Taken together, we continue to believe that three zero 11 is an active agent and treatment refractory tumors and has the potential to become a first in class treatment for a significant number of patients who experienced a failure of at least one prior line of therapy.
Now turning to our second cab ADC assets VA, three zero 21, a cab or two ADC.
For our ongoing phase II trials, we have completed enrollment of approximately 20 patients at the Q2 W dosing regimen in both lung cancer and melanoma.
And anticipate to complete enrollment of up to 20 patients at the two Q3 debut dosing regimen and head and neck cancer before year end.
And treatment refractory patient populations. They are encouraging early responses in the phase two melanoma study at the Q2 W. Dosing regimen that are consistent with our phase one expansion study.
In particular, among the eight evaluable monotherapy patients to date with reported firsthand across phase, one and phase II clinical studies.
We have observed for responses to stable disease, one of which was a 17% tumor volume reduction in uveal melanoma and two with progressive disease.
Notably we have now observed a PR at Hayward to Gnps negative patients, which is likely to expand the applicable patient populations.
We are continuing to collect data in the ongoing study and the remainder of patients from the targeted melanoma cohort will have had the opportunity to have firsthand by year end.
There are also encouraging early responses in head and neck cancer to Q3 W.
Also with our new PR observed an award to <unk> negative patients, which makes two out of two responses at the Q3 W dose across phase one and phase two.
We are on track to complete all dosing regimens enrollment by year end and we will continue to collect data in the ongoing study.
The Aurora two melanoma indication recruitment has been assisted by enrolling targeted ignostic patients followed by a retrospective target expression analysis, both of which resulted in quicker enrollment and the opportunity to target a larger melanoma patient population.
In the case of head and neck cancer, where two is expressed in a significant portion of these patients and therefore it is also not anticipated to benefit from biomarker assay, particularly in view of the observed <unk> three WP or in a <unk> <unk> negative patients, which maximize the potential applicable.
Patient population.
The award to positive lung cancer patients at Q2 W.
While we observed clinical benefit in terms of substantial stable disease and tumor volume reduction.
There are no responses to date and thus we did not meet our internal criteria for advancing at this dose.
Further in view of these results and our supportive axle lung cancer data. We currently do not plan to internally explore the more frequent to Q3 GW to dose for this indication.
Regarding the ovarian.
Key interim analysis of 10 patients in each of the.
<unk> zero 11, and be a <unk> 21, Q2 W cohorts demonstrated modest disease control.
Did not meet our internal criteria for advancing at this dose.
Currently do not plan to internally explore additional dosing regimens at this time for this indication.
Now on to our other promising cap assets, beginning with our <unk> four antibody <unk> three zero 71.
Which is applicable in areas of high unmet need and treatment refractory patients.
Presents a sizeable commercial opportunity we.
We have encouraging phase one observations to date and we continue to follow these patients progress.
In contrast to approved in earlier stage <unk> four blockade antibody <unk> zero 71 is designed to be conditionally and reversible reactive in the tumor micro environment we.
We believe this unique design enables our caps, it's only four antibody to have the potential to deliver efficacy with a manageable safety and tolerability profile.
In particular.
The safety profile with less immune related adverse events across multiple tumor types may allow patients to stay on therapy for longer and achieve clinical benefit from this important immunotherapy.
The phase one two trial is being conducted in tumors known to be responsive to <unk> for treatment and we are continuing to evaluate safety and tolerability of <unk> 71 in monotherapy and in combination with Nikola map.
As part of today's brief update.
I'm happy to report that we have initiated the phase II expansion cohort enrollment and remain on track for the phase one data readout, which will be highlighted at our upcoming R&D day on December 13th.
Next onto our potentially first in class dual cab bi specific T cell engaging antibody cab fkn cab <unk> III.
Three 182.
We've previously announced FDA clearance of our IND for the treatment of advanced adenocarcinoma and last quarter, we announced that the phase one study was actively enrolling patients.
That is progressing nicely through the dose escalation part of the phase one study and we anticipate completion of the phase one study with a full data readout remaining on track for next year.
We believe that our dual cab design has potential to address tremendous unmet need across multiple tumor types with the most common subtypes of adenocarcinoma.
Including colon lung breast pancreas and prostate.
I'd like to round out today's talk with a corporate update first in addition to our leadership team.
Recently, Dr. Ben Joe joined <unk>, as senior Vice President head of clinical development and operations.
Brings over 20 years of experience in clinical practice early and late stage drug development and asset management with a focus on oncology drug development.
Prior to joining <unk>, he held leadership roles with increasing responsibilities, including at Bristol Myers Squibb Gibson.
<unk> bioscience.
And most recently as senior Vice President head of clinical development of that system collagen carryover some clinical development activities of all oncology assets as regulatory interaction experience coupled with his known track record of leading cross functional teams will be instrumental as we advanced clinical development efforts and strategic collaborations.
We are thrilled to have been on board with bio lab.
And finally I'm pleased to report our progress with the medical and scientific communities with an additional abstract on <unk> zero 11 alone or in combination with <unk> in patients with lung cancer, which was accepted for presentation at the upcoming <unk> Conference. This December.
We also look forward to sharing these data and additional details around our capex on <unk> ADC asset.
At our upcoming Kols event on December 4th.
Moreover, we will present, our phase <unk> 430, 71 study data at our upcoming R&D day on December 13th.
With that I would now like to turn the call over to Rick to review the third quarter 2023 financials Rick.
Thank you Jay.
Cash and cash equivalents as of September 32023.
$141 3 million compared to $216 5 million.
December 31 2022.
We now expect current cash and cash equivalents will be sufficient to fund planned operations, including prioritize cab programs into the second half of 2025.
Research and development expenses were $28 4 million quarter.
Quarter ended September 32023, compared to $19 8 million for the same.
I'm hearing in 2022.
The increase.
$6 million was primarily driven by a $6 $3 million increase in our clinical and product development expenses.
Merrily related to the launch of our XO.
Potentially registrational trial, and a $1 8 million increase in additional product development expenses.
We expect R&D expenses to remain variable quarter to quarter as we continue to advance our clinical programs then decreasing after we complete enrollment and focus development on selected.
Potential indications.
General and administrative expenses for <unk>.
$6 6 million for the quarter ended September 32023, compared to $6.3 million from the same quarter in 2022.
The $3 million change of attributable to an increase in professional services and consulting expenses for the 2023 periods.
We expect G&A expenses to remain flat to moderately increasing support development of our prioritized cab programs.
Net loss for the third quarter ended September 32023 was $33 3 million compared.
Compared to a net loss of $25 8 million.
For the same quarter in 2022.
Net cash used in operating activities for the nine months ended September 32023.
$74 1 million.
To net cash used in operating activities.
$66 $1 million for the same period in 2022.
The increase in net cash used in operating activities for the first nine months of 2023.
Primarily due to an increase in research and development expenses related to our program development efforts as compared to the first nine months of 2022.
And now back to Jay.
Thank you Rick Biomet was dedicated to delivering innovative life changing therapies to cancer patients. We observed that the <unk> platform continues to demonstrate compelling clinical efficacy and safety across multiple therapeutic targets and formats and the most challenging cancer cases.
As a result, we believe that there are mutually compelling opportunities for forming one or more strategic collaborations with major pharmaceutical partners that both accelerated and maximize the therapeutics opportunity. In addition to advancing collaboration discussions we will continue to advance selected cap assets that can address significant unmet medical needs.
In order to maximize shareholder value.
With that we will turn it back to the operator to take your questions.
Thank you and ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by the number one on your telephone keypad, you will guarantee Don crop of Belgian Uruguay and your questions Ravi bold in the order. They are received should give us the declines on the calling process with breast.
Star followed by the number Q.
Using a speakerphone please pick up the handset before pressing anarchy one moment. Please for your first question.
Okay.
Your first question comes from the line of Brian Cheng from Jpmorgan. Your line is open.
Hey, guys. Thanks for taking my question this afternoon.
Given the responses that you saw here now offer axe, all again Egfr wild type in PD, one Tim and failure patients.
The extent that you can can you give us a sense of the verbal feedback that you receive on divestitures and a path forward from the agency.
And what are the expectations that we put that in terms of.
A pap or at December event.
I'll start and maybe Eric can add if he has anything to add.
So they gave us some very clear.
<unk> items, both either in second and third line therapies and so we're just waiting for the written confirmation of the verbal communication as soon as we have that we expect that a little later this month and we'll be communicating that in far more detail in December but hopefully that's helpful and we.
We think it's very promising.
Okay and then.
Related to the Ias LLC conference presentation.
Next month can you talk about this.
What we should expect in terms of the level of details regarding to respond.
And can you also comment on that durability of the response that you've seen so far in that non small cell.
Okay.
Eric do you want to lead off on this phone.
Sure I think we'll be having a pretty standard poster presentation of the data sets, including Spider plots swimmer.
Swimmers plots.
And so you can anticipate that.
Also I would add will also have.
Monotherapy, obviously is our focus we will provide the data on the combo. The updated data on the combination therapy and also our initial look on a more frequent dosing.
Data.
May be more we'll see how that goes in the next few weeks.
Also remember the day after.
Oh all of it.
Yeah.
And your next question comes from the line of Covid, Paul Lang from <unk>. Your line is open.
For taking my question.
So.
For non small cell lung cancer <unk> has in our phase III <unk> trial ongoing and in their most recent press release season also announced that they will be initiating a phase II trial for integra.
Integra and beta <unk> targeting ADC.
So.
I was just wondering if you could tell us how youre thinking about the competition here and what level of target expression overlap do you expect to see between trop, two beta sticks and Axel.
I'll start off and then maybe Eric sure it could add to this so first off I think.
You can look at both pieces of data, we've seen that multiple responses at 1% to MTS level.
We're not seeing a strong correlation and responses and stable disease to the level of actual expression and this is I think.
Observe bile a number of different age groups.
Groups at least in the grips with Adcs studying lung cancer. We're also.
Reporting.
Sponsors are more too as well from where to negative patients. So we're in the process right now of evaluating the <unk>.
Frequency.
Okay.
Actual negative patients based on the IFC assay and I think I'll, just remind everyone that I guess yesterday has its own sensitivity just because you don't see OXXO by that kind of assay doesn't mean you have no actual expression is just at a much lower levels. So we think that this has a chance of broad meeting.
The actual market opportunity here. It also because of the actual being a poor prognostic indicator, meaning the patients have a very difficult time in these maybe some of the most difficult patients to treat remembering that all the entire study.
All of the patients had a median of three prior lines of treatment and they were actual positive. So there is.
Zero.
Significant likelihood that we're going to see responses below 1% and we're going to find that out and add that to the datasets, which could have a substantial impact on the market opportunity of our drug. So we think a cross trial comparison is a little difficult when you when the others Havent gone into an actual positive data set.
And so we're going to look more broadly and I think we'll have more data on that as we go forward Sheri our ericsson at or.
Clarify Casey.
Astronaut Christian I hope that answers your question.
Yes, Jay I think.
Characterized that very well.
Thank you.
Okay. Thank you and just if you could provide any more details about the assay youre using for actual expression assessment and how are you thinking about its use.
Yeah, sorry, how are you thinking about its use like when moving from early stage two pivotal trials.
Well I think it's an immunohistochemistry.
Assay using an antibody against actually its not that our therapeutic antibody. That's one that was specifically selected for detecting axle expression.
On cancer cells and of course, we've been looking at.
A lot of people are used to the H score when you look at the level or the amount of expression on <unk> versus the number the amount on the on the member number of cells that have expression of the membrane and so it hasnt been inherent sensitivity. So the fact that we're seeing.
Sponsors as.
But.
But as of this moment, we believe we validated.
At the level of 1% or greater with a T. M. P. S. Four.
And these.
Patients refractory patients with three prior lines of therapy and show that we have a path forward here with these and Thats in third line. So we think it will do even better in second line, but for the moment, we're going to look to see if we can have similar or even potentially greater impact and ones that are less than one.
1% given that poor prognostic indication of actual expression with actual expression.
So.
What's nice about this strategy is that the recruitment now is uncouple from having to require at least to finish off this analysis.
Our net all patients to our study.
Do a retrospective analysis. This allows us to look at those patients with less than 1% as well as summit a few additional ones.
With 1% or greater and we're going to add that data very quickly.
Two our current datasets and.
As we go forward with some of our partnering discussions.
Thank you that's very helpful.
Okay.
And your next question comes from the line of Ken <unk> from Jefferies. Your line is open.
Okay.
Okay.
Hello.
Kelly.
You might be on mute.
Hello.
You hear me.
Now we can.
Hi, This is Dave on fire Kelly's Kelly and I have a question on <unk> zero to one do you plan to share our non small cell lung cancer data that you generated and.
If you can shed any insight that you can draw from that data participation baseline or exploration.
Which contributed to lower responses also far.
<unk> four can you set the expectation on data or detail participation number of dose levels, we should expect.
At the R&D.
R&D day, thank you.
Yes.
We will definitely share the data on the non small cell lung cancer data, we're going to link that to a meeting. We may also include data.
From the more frequent dosing with some of the other indications like head and neck cancer and melanoma she'll be looking forward to upcoming meeting on that.
It's still quite possible picking up because we saw responses in lung I'll remind everyone in phase one, but what we basically show that we're not driving responses with the Q2 <unk> level.
We're also seeing responses with two Q3, W and head and neck, but.
So we think that potentially there is potential to go to a higher dose, but as part of our prioritization process wishes.
The factor in our very encouraging data out of the actual lung data and.
And we will.
We'll have quite a bit more data that we'll be putting together for that release.
With respect to see till a four.
We will we're on track to give us quite a bit of detail on our phase one dose escalation and we will be giving an update on the phase III results, but suffice it to say that the fact that we've already kicked off phase two and that we have our first patient in phase II.
That.
We think that it's heading in a very good direction and I'll remind you that we've been studying patients.
That are known to be responsive to <unk>.
Basket of eight different indications that include things like melanoma, non small cell lung cancer. So it will be.
Discussing all of that.
Timber and so.
Just invite everyone on December 13th for that R&D day. So we can give you a lot more detail around those studies.
Thank you for taking my question.
Yes.
And once again, if you would like to ask a question simply press the star followed by the number one on your telephone keypad.
Your next question comes from the line of Arthur <unk> from <unk>.
Your line is open.
Hey, good afternoon, Jay Rick Sheri and Eric.
Thanks for taking my question.
So I just wanted to push the envelope a little bit further on.
The <unk> 11.
33, 3%.
Also including both the Q2, <unk> and the more intensive dosing regimen or it's <unk> or the <unk>.
The only Q2 W. We haven't reported out on any more frequent dosing yet.
Okay. Thanks for that.
And then regarding to the.
Yeah.
New program.
For the.
Our two negative melanoma patient, which showed a response is that patient is in the phase II study or.
So on the phase one study.
You remind that.
For head and neck, you mean.
No for the melanoma.
For melanoma.
We have we have to excuse me have one response from phase one.
That's included and we have three responses from phase two.
Okay.
And so far so you said you're competing enrollment so how many.
Total patients we could expect the next data update.
No I don't know what the value evaluable patients will be but we are.
Had targeted 20 patients so we'll see.
Where we go on that and we have reported an eight evaluable patients today, where we saw four responses out of eight.
Two with stable disease, and two with progressive disease, so quite encouraging at this stage.
Got you.
So my last question is.
For the.
30, 31 82 your Bispecific.
Candidates for that.
So could you give us some more color.
The enrollment status for that for that trial.
I think it's I think it's growing well.
It takes.
You know about a month.
Plus or minus a week to kind of get from patient to patient. So I think we're on track here and.
We continue to dose escalate and yeah.
You know I think.
It's early but.
All good so far and this is a particularly interesting drug and I get why it would be asking the same question that you are because.
One of them one of those pan cancer opportunities with very high fill activity with a very potent mechanisms that is enabled by cabs with this T cell recruiting capability and so we're very eager to push it along so it's going to it's going to move quickly and we'll have a lot more to talk about it.
And we have only seen positive things so far.
Awesome. Thanks for taking all my questions and congrats on the program.
Thank you.
Unfortunately, thank you and there are no further questions at this time I would like to turn it back to Jay Shah for closing remarks.
Thank you everyone for your attendance, we're really looking forward to continuing our <unk>.
Discussions, especially with <unk>.
Medical experts in early December as the only a few weeks away and we're looking forward to speaking with many of you at that time take care now and all the best.
Thank you presenters, ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect.