Q3 2023 Aadi Bioscience Inc Earnings Call
Okay.
Good day, and thank you for standing Bosch and welcome to the <unk> Biosciences third quarter 2023 earnings Conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question during the session need to press star one on your telephone.
You will then hear an automated message advising your hands raised.
Your question. Please press Star one again, please be advised today's conference is being recorded I would now like to.
And the conference over to your Speaker today, Mark Graham Senior Vice President of Investor Relations and corporate communications at <unk>.
Mr. Graham. Please go ahead.
Thank you.
Good morning, and welcome to the <unk>.
This conference call to provide an operational update and review results for the third quarter 2023.
Joining me on the call today, Dr. David <unk>, our president and CEO.
Jakob Allen, our CFO and our Chief Medical Officer, Dr. Reddy he treat.
Today, we will provide an overview of operational activity and financial results for the third quarter of 2023, and an update on our precision one trial and clinical development plans going forward.
We will open the line for questions at the end of the call following closing comment.
A quick reminder, that statements made on the call today will include forward looking statements.
Actual events or results could differ materially from those expressed or implied by any forward looking statements as a result of various risks uncertainties and other factors.
Leading those set forth in the risk factors section of our annual and quarterly filings with Securities and Exchange Commission, which can be found at www SEC Gov or on our website at www dot antibody dot com.
In addition, any forward looking statements made on this call represent our views only as of today November eight 2023 and should not be relied upon as representing our views as of any subsequent date.
We specifically disclaim any obligation to update or revise any forward looking statements.
With that I will turn the call over to our CFO Scott Chuck of Belo for his opening statement it's Scott.
Thank you Marcy and good morning, everyone.
Thank you for joining us today to review, our financial and operational results for the third quarter of 2023.
Before we discuss our progress in the third quarter and activities currently underway I would like to take this opportunity to introduce Dave Lennon.
And us as president and CEO at the start of the fourth quarter.
Dave comes to us with more than 20 years of pharmaceutical leadership and deep expertise in them towards driven diseases with a history in oncology and rare disease and a strong background in U S and global commercialization.
All experiences that make him the perfect choice to guide, adding into our next phase of growth and development.
I am excited about the future and look forward to working with Dave continuing in my role as CFO.
Now I'd like to turn the call over to Dave for his initial comments Dave.
Thank you Scott I appreciate the warm welcome and introduction I would also like to thank you for taking the role of interim CEO prior to my joining.
The entire management team for all their hard work in getting us to where we are today.
The unique combination of technology timing and tea is what drew me to Adam.
Here's a great opportunity here to build on the success of the inventory inhibitor class in cancer.
Our groundbreaking therapy Napster lineups allows us to generate deeper inhibition of the <unk> pathway at the site of tumor and hopefully more potent anti cancer activity, resulting in better patient responses.
We've proven this in our first indication of Tacoma, a rare soft tissue sarcoma and another unique moment as a company, where we expect to have multiple data readouts over the next 12 to 18 months from our highly anticipated tumor agnostic study precision one.
I am also fortunate to be joining Eddie with an excellent team who continue to execute on an ambitious commercial and clinical programs focused on building a leading precision oncology company.
And I'm very happy to share their strong performance over the third quarter importantly.
Importantly, precision one continues to enroll rapidly and we now expect to present early interim data by mid December.
We will share more of our trial progress and upcoming catalysts in a moment.
<unk> sales remained solid at $6 million in the third quarter, a 40% growth over the prior year.
$2 million in cumulative sales in the first nine months of 2023.
We are also executing on our previously announced development strategy with the initiation of two phase III studies of Napster wireless.
One in combination with standard of care in endometrial cancer and the other is a single agent and neuroendocrine tumors. These are in addition to our ongoing trial in combination with varieties K Ras inhibitor in lung cancer and other solid tumors.
A key focus of our organization has been realizing the potential of napster alignments for patients with solid tumors harboring, either <unk> or <unk> and activating alterations.
This type of genetic alterations are thought to activate the <unk> pathway, leading to uncontrolled cell growth in our precision. One trial is an interventional study designed to elucidate the potential of napster alignments to treat all types of tumors with either of these alterations.
The unmet need in <unk> mutated cancers, sizable whether considered together or independently.
We presented data at this fault.
<unk> symposium or Triple meeting based on next generation sequencing of mutations of nearly 440000 cancer patients from the Foundation Medicine database.
This large real world evidence provides the best look at data to date on PSC, one or <unk> two mutation frequencies across all common tumor types.
This is corroborated our previous estimate that patients with TST, one our TLC to represent about 2% of all cancer patients.
Our latest internal analysis indicates there are approximately 16000 patients with these mutations across a variety of tumor types.
With mutations roughly evenly split between gene each mutation represents potential multibillion dollar total addressable market for <unk> lines.
PSC, one or two driven cancers are found across a wide range of tumor types clustering and long gastrointestinal general urinary breast and gynecological locations and are often difficult to treat we believe precision one is cutting edge trial testing our innovative therapy napster alignments in these cancer types.
With that background I'd like to turn it over to Loretta who will speak further to the details of this unique tumor agnostic trial and our plans going forward.
Thank you, Dave and good morning.
Everyone.
As Dave noted precision one is a unique study and one without cohorts segregated by specific tumor types, making it truly tumor agnostic.
This is an ambitious and adaptive trial intended to elucidate the impact of Napster I'll Miss on cancers, expressing inactivating mutations of TST, one GSE queue, regardless of tumor type.
We are very pleased with the continuing advancement of the trial. The number of open sites has increased as has access to patients with more than 150 sites available to us using our just in time mechanism that allows us to open prequalified sites within as little as a two week peer.
<unk>.
Working with our Ngls partners and benefiting from the broad outreach afforded by our clinical sites, both academic and community based.
We're able to effectively identify and track patients with TFC, one or TFC Chew Inactivating alteration, who have an interest in participating in our study.
Accruals between the two arms has been remarkably even as predicted by the real World data recently published at the <unk> annual meeting.
We continue to have a very broad representation of solid tumors with more than 25 discrete tumor types enrolled in the trial to date.
It is important to remember that although precision one is designed as a single trial each arm independently evaluated providing us with the ability to assess one arm separately from the other.
Given this design precision one can effectively be viewed as two separate studies each with its own outcomes.
These are not just two studies they are two standalone tumor agnostic studies.
Consistent with the adaptive statistical analysis plan there are two preplanned interim analyses in the near future one at one third enrollment, which we plan to report in mid December of this year and another at two thirds enrollment, which we expect to report in the third quarter of 2024.
Sure.
The interim analysis that will be performed when two thirds of patients are accrued and have been followed for six months, we will evaluate the primary endpoint of the study DMC evaluated O R. R.
Will provide us with the opportunity to modify the study or to file early if the data warrant.
The upcoming per protocol interim analysis planned for later this year will include early data on tumor type distribution safety and investigator assessment of response using resist criteria on approximately 20 evaluable patients from each arm.
We expect these results to reflect a broad representation of tumor types very treatment histories and lines of therapy.
We have built great momentum in our precision one program and look forward to delivering on key milestones. Both later this year and throughout 2024 weeks.
We expect to have completed enrolment by the spring of next year well ahead of our planned delivery of the two thirds interim readout in the third quarter and to complete the study by the end of 2024.
We remain very excited about the potential of this important study and the promise of Napster all of US and look forward to communicating the preliminary results from the precision <unk> trial in a few weeks.
I will now turn the call over to Scott for updates on our financial progress Scott.
Thanks Loretta.
On the financial front, we remain well capitalized and in the third quarter was $119 3 million in cash cash equivalents and short term investments, which is expected to fund operations into 2025 based on current plans.
<unk> sales were $6 million in the quarter, representing 40% growth over the same period in 2022.
Research and development expenses for the quarter increased to $11 9 million as compared to $8 8 million in the prior year quarter.
This increase was primarily related to the continued progress of the ongoing precision <unk> trial and the build out of the R&D organization.
Selling general and administrative expenses for the third quarter were $11 2 million compared.
Compared to $99 9 million for the same period in 2022.
This increase was due primarily to the build out of a company infrastructure and increased marketing expenses related to <unk>.
Net loss for the third quarter was $16 $3 million.
Compared to $14 4 million in the prior year quarter.
For more information on our financial performance for the third quarter, a detailed discussion of the results reported on this call will be provided in our Form 10-Q.
I'll now turn the call over to Dave for his closing comments Dave.
Thanks, Scott as I said earlier, we are truly excited about what lies ahead, we have defined two sizable markets in cancers, with <unk> or <unk> and activating alterations and look forward to sharing the upcoming precision one interim analysis planned for mid December.
Beyond that we are excited about the new catalysts coming up in 2024, including our two thirds interim analysis in the third quarter we.
We expect to reach full enrollment in the trial in the spring of next year fully completing the study by the end of 2024.
We can now open the line for questions operator.
Thank you ladies and gentlemen, if you have a question or comment at this time. Please press star one on your telephone. If your question has been answered you were seeing with yourself from the queue. Please press star one again, we will pause for a moment, while we compile the Q&A roster.
Our first question comes from Boris Speaker with Cowen Your line is open.
Great. Thanks for taking my question.
Two questions for me first on that second interim analysis, which you estimate in <unk> of next year, what efficacy do you need to stop early.
And second.
In the <unk> market for VR do you have any sense of kind of what the duration of therapy is turning out to be thank you.
Okay. Thanks, very much further questions in terms of the second interim I wouldn't comment at this point about what efficacy needs to be obviously, we have two arms running within the study and the context of response rate and duration in that combination needs to be considered when we think about potential for stopping.
Ah study early but of course, we do have that option at that point in time.
On the Tacoma side in terms of duration I think what we can see is that duration is consistent with what we've been seeing.
In the clinical trial and.
Yes, that's what I would comment at this point.
Great. Thanks for taking my questions. Thanks bars, and remember for our next question.
Our next question comes from Joe <unk> with Piper Sandler Your line is open.
Hi, everybody I appreciate you taking my questions maybe a couple for me on precision one so so far the initial interim expected by year end with a minimum follow up of four five months can you just let us know what minimum amount of post baseline scan that insurers.
And then.
For the second interim analysis I think this is the first we're hearing on this so was this always the plan and if not what drove the decision to take another look and then sort of along these lines Laura if I heard you right. The second interim analysis will allow you to modify the study just wanted to understand that a little bit better.
Given it sounds like the study will be fully enrolled by that time, what modifications, maybe you can potentially employ them. Thanks.
Okay.
Sure so.
Alright, do you want to comment on that.
Those first three areas.
Hi, Joe Thanks for your questions.
So let me.
Let me.
Reply.
So the.
I'm sorry.
Kind of have the order of your questions a little bit confused do you think you could repeat the first one please yeah sure I'll be I'll be quick here. So the minimum amount of post baseline scan that's insured with four five months of follow up and then the second interim analysis with this.
Or is this something new on what drove that decision and then what modifications you could potentially.
Take post the second interim analysis.
Given that the trial would have been fully enrolled by that point.
Okay, great. So.
A four five month guarantees at least at least two post baseline scans.
Everyone will have at least the ability to have that kind of follow up.
The.
The interim analysis the second interim analysis at two thirds that you were asking question about has always been in the statistical analysis plan.
It is an adaptive design.
This is a very common when approximately two thirds of patients are on study to have a look.
To assess whether or not the <unk>.
Sample size.
Is.
Is sufficient to file early or whether or not you might want to consider re sizing.
So those are both options that we would have.
When when that interim occurs but this this analysis was always planned.
And.
We will have six months of follow up. This is this analysis will look at the independent.
A review of Radiological scans.
And we will be performed by <unk>.
Pending data.
Maturing committee.
So.
Even though we will have.
Completing enrollment in the study presumably by that time.
We will still be requiring additional follow up on the entire cohort.
I hope that addresses your questions.
Yes, It does super helpful. Thanks for taking my questions. Thanks tore so welcome.
One moment for our next question.
Yes.
Our next question comes from Roger song with Jefferies. Your line is open.
Great. Thanks.
Thanks for the update and taking our questions a couple from us in terms of the Internet and now we have to.
Maybe can you, let us know I understand you're not providing the guidance right now.
Which in turn analysis.
At all you will contextualize the efficacy against that.
The FDA statistical hurdle or no.
The standard of care, you have been providing to the FDA as the benchmark. So we can we can now.
Each.
Alright, and then assess the efficacy or the or will be reaching the.
The goal you want to achieve.
Thanks for the question Roger I'll take this one.
It's important to note that this interim that we're presenting in December is based on one third of patients enrolled in a minimum of four five months of follow up. It's also investigator assessed <unk>. So this is not the primary endpoint of the study which is independently assess overall response rate and.
The second interim is actually based on the primary endpoint and it will be at that point, we would be testing against the statistics of the plan.
Got it so in that in the second.
Interactive you will do the primary endpoint analysis.
We'll be at that point, you will let us know, what's the hurdle for that or you would just let us know okay. We are not stopping the trial and will continue for the for the full data.
We view the hurdle to be something that is probably is a review issue and we probably wouldn't talk about that at that point in time.
But rather give us a sense of what the efficacy measures, we're seeing aren't weather, where we are with the trial in terms of continuation.
Yes.
Got it. Thank you maybe just a quick follow up quick.
Quick follow up on this stage that you say you will complete the trial by the end of 2034.
And when should we expect a full data from the trial. Thank you.
Yes, it's still.
It's roughly at the end of 2024 or early 2025.
We haven't we.
We anticipate it's probably more likely early 2025 at this point, but we'll give a further update once we complete enrollment.
Okay.
Excellent. Thank you that's it from us.
Wondering for our next question.
<unk>.
Yeah.
Our next question comes from <unk> <unk> with Ladenburg. Your line is open.
Good morning team. Thank you for taking my questions. Two questions first one is regarding the triple meeting.
Presentation, it looks like P 53, more frequently observed.
Comorbidity curious how that might impact this quote morbidity, how they might impact apparel activity and during the interim analysis will you disclose the other mutations in the patients or is it going to be more high level.
Okay.
Yes so.
I'll take a first crack and Laura to back me up on this.
<unk> three is is the most common mutation commutation that you see in that analysis for patients across 440000 cancers that we looked at.
And our internal calculations when you look at those distributions indicators potentially 16000, new cancer patients.
Each year with either tier one or tier two mutations.
About 50% of those if I recall the data correctly had co mutations in P 53, and the <unk>.
Adult although that while high.
Overall is very consistent with what you see across all tumor types in all types of cancers.
<unk> 53 is the most common commutation in general.
For different types of tumors and so it's not different from what you would might expect overall and given that we've seen responses to patients with PSC wanted POC to altered cancers in the past and the retrospective analysis that became the basis for precision one position too we wouldn't expect it to.
Really negatively or impact the trial in any way and we believe it would work within that context.
And Laura I don't know if you would add anything to that.
No I think that's entirely correct I would have answered it the same way and.
And then in the interim we won't we won't be presenting co mutation status at this point in time the numbers while significant in terms of an initial indicative nature of how the trials going we don't believe would be sufficient to really to <unk>.
Detailed analysis of co mutation status that would be robust enough to make any determination about at this point, so we won't be sharing that data.
That's helpful. My second question is on the endometrial program.
The trial is enrolling how many place that open and when do you expect to see initial data from stage one portion of the study.
Okay.
So we are.
We've just started that study I wouldn't comment on the number of sites we have.
The community is very excited about engaging in this study.
And we hope to have an update on the study.
Sometime in 2024.
Great. Thank you for taking my question.
Thanks.
And I'm not showing any further questions at this time I would like to turn the call back over to Dave for any closing remarks.
Super Thank you very much Kevin and thank you everyone for joining us on today's call as we mentioned, we're really excited about the progress we're making on our precision one trial with the interim analysis planned for mid December.
Exciting catalysts for 2024 that could propel our need to growth. We appreciate your time and look forward to the opportunities in the future to provide additional updates on our process.
Progress I should say, thank you for joining the call and have a great day everyone.
Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
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