Q2 2023 Aadi Bioscience Inc Earnings Call
Okay.
Good day, and thank you for standing by welcome to the <unk> Bioscience incorporated second quarter 2000.
23 earnings call at this time, all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need to press star one on your telephone you will then hear an automated message advising that your hand is raised.
Draw. Your question. Please press Star one again, please be advised that today's conference is being recorded I would now like to hand, the conference over to Marcy Graham Senior Vice President of Investor Relations and corporate communications at <unk> Biosciences Ms Grant.
Okay.
Thank you good morning, and welcome to the Eddie Bioscience Conference call to provide an operational update and review results for the second quarter 2023.
Joining me on the call today is Scott Chuckled Bello, our CFO and interim President and CEO , who will provide an overview of financial and operational activity during the period, including an update on our continued commercial progress and he will be followed by our Chief Medical Officer. Dr. Reddy, each Regal will provide an update on our precision one study.
And clinical development plans for 2023.
We will open the line for questions at the end of the call following closing comments.
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, including those set forth in the risk factors section of our annual and quarterly filing.
<unk> with the Securities and Exchange Commission, which can be found at www SEC Gov or on our website at www Dot Eddie bio Dot com.
In addition, any forward looking statements made on this call represent our views only as of today August nine 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 Scott for his opening comments Scott.
Thank you Marcy and good morning, everyone.
Thank you for joining us today to review, our financial and operational results for the second quarter of 2023.
We continue to see solid performance from our commercial and clinical organizations during the quarter each focused on driving results as we enter the second half of the year.
<unk> sales for the quarter were $6 2 million showing continued growth with a 6% sequential increase over the previous quarter and 80% growth over the prior year quarter.
Efforts by our sales and marketing teams in the field are driving awareness and educating key stakeholders, reaching healthcare providers and very channels and we are pleased with the positive feedback from physicians on the efficacy and safety of <unk> as we see greater utilization in the first line setting.
Separately the precision one trial is progressing well and we're looking forward to providing results on an interim analysis of 40 patients with appropriate follow up before the end of the year.
We are enthusiastic about the potential of this trial to significantly broaden the future application of napster Carolinas across many different tumor types and in a much larger patient population and we currently address input call presenting an exciting opportunity for additional growth.
Beyond the precision one study we have continued to evaluate the potential use of <unk>. Your line is in a number of new clinical indications either as a single agent or in combination with other targeted therapies.
Today, we are announcing the expansion of our Fi our pipeline through the further investigation of <unk> pathway inhibition in endometrial cancer, and neuroendocrine tumors or <unk>.
Our preclinical data and new indications is promising and we believe in the potential of our technology to harness the unique pharmacology of knobs to airlines to provide enhanced therapeutic benefit for patients.
Loretta will join us shortly to provide greater detail on these and other aspects of our clinical programs.
This is a year of execution on many fronts, which now includes the launch of new programs that we believe will reflect the value of <unk>. Your line us as a potential treatment in additional indications targeting genetically defined cancers with <unk> pathway alterations.
But <unk> is up next to provide an update on our precision one trial and discuss our ongoing clinical activity Loretta.
Thank you Scott.
Everyone.
Throughout the second quarter, we have continued to make advancements in our ongoing precision one tumor agnostic trials in <unk> naive patients with malignant solid tumors harboring T. S. C. One Archie S C chew and activating alterations.
This prospectively designed trial is evaluating patients in one of two independent study arms, one with solid tumors harboring TFC, one and the other with GST Chu.
We continue to observe a relatively even rate of accruals between the two study arms.
We also continue to have a very broad representation of solid tumors across more than 15 discrete tumor types and fully expect the results of this trial to represented truly tumor agnostic outcome.
Importantly, the safety profile, we have seen thus far is entirely consistent with that seen in the impact study and no new safety signals have emerged as enrollment continues to increase in this diverse and heavily pretreated population of patients.
The trial is progressing well and we continue to target full patient enrollment by the spring of next year 24 months. After the first patient was enrolled.
We are looking forward to sharing further information on the precision one study before the end of the year when the overall investigator assessment of response will be presented in conjunction with a preplanned interim analysis on 40 patients with appropriate follow up.
We remain excited about the potential of this important study and the promise that napster I'll Miss may hold for the treatment of this diverse population of patients in need.
We also believe that the potential of Napster, all and this extends beyond coma and TST, one and two indications which is why we have continued to investigate its use in a number of new clinical indications both as a single agent and in combination with other approved therapies.
With the precision <unk> trial, well on track we are pleased to share that we are initiating a phase two trial investigating the combination of napster I'll Miss with Letrozole for the treatment of advanced or recurrent endometrial types endometrial cancer or more easily stated E C.
<unk>.
This is an open label multi institutional study to evaluate the efficacy and safety of napster elements and letrozole in patients with advanced or recurrent endometrial like endometrial carcinoma.
Prior clinical studies with <unk> inhibitors have yielded promising data in this area and we believe there is potential for the combination of Napster I'll Miss with endocrine therapy should produce synergistic anti tumor activity in patients with recurrent endometrial type endometrial cancer we.
<unk> to initiate patient enrollment in the fourth quarter of 2023.
Given the very recent change in our recommendation for first line standard of care treatment, which now includes chemotherapy plus immunotherapy. We believe that there may be a unique opportunity to develop napster I'll Miss plus letrozole in endometrial carcinoma following chemo immune.
No therapy failure.
In addition, this fall we expect to launch a phase two multi center open label single arm trial to evaluate adult patients with functional or non functional well differentiated locally advanced unresectable or metastatic neuro endocrine tumors or niche of the.
<unk> tracked lung or pancreas, who have received no more than two prior lines of therapy.
Given the historically low response rate of this tumor to treatment with oral wrap logs and other agents, which nonetheless are used clinically and recommended in treatment guidelines, we anticipate being able to demonstrate the clinical superiority of napster elements in this population for the purposes of future publication.
The phase one two trial of the combination of Napster, all I'm missing that aggressive in patients with <unk> mutations has now started with the first patient dosing is completed.
The study conducted in collaboration with Marathi Therapeutics is evaluating the combination of that aggressive with napster elements and is intended to determine the optimal dose and recommended phase two dose in patients with Kers G 12, C Muse with solid tumors.
As you can see we are active on many fronts. The activation of new studies. In addition to the planned progression of precision one are the foundation of our growth strategy.
I will now turn the call back over to Scott for updates on our commercial and financial progress Scott.
Thanks Loretta.
Addition to our clinical advancements we are pleased with the continued commercial progress of <unk> for patients with <unk>.
We are seeing steady product demand growth and commercial access remains very strong with more than 90% commercial lives covered.
We reached $6 2 million in sales for the second quarter, which represents growth of 6% over the first quarter of 2023, and 80% growth on a year over year basis.
Our sales to date have reached more than $27 million in just 16 months on the market.
At the end of the second quarter, we had more than 165 unique ordering accounts up 13% from the first quarter.
The reorder rate was approximately 85% in the quarter underlining the positive experience with final.
The uptake in community clinics and hospitals has been consistently strong representing approximately half of firearm sales nationwide.
As the only approved therapy in Pacoima fire will continue to increase share as a frontline therapy.
Our team continues to drive awareness and education, and our efforts to cement <unk> as the gold standard for malignant <unk>.
As they do so it's becoming clear that stakeholders understand the value and differentiation of firearm put tacoma patients.
Our tracking shows significant physician awareness of <unk> with 65% overall and an impressive 80% awareness for those specializing in sarcoma.
The feedback we are receiving is also robust and indicate that providers are readily adopted.
As a top choice for treatment of their patients.
On the financial front, we remain well capitalized ending the second quarter with $134 9 million in cash cash equivalents and short term investments, which is expected to fund operations into 2025 based on current plans, including the additional programs and.
Dmitry cancer and nuts.
Research and development expenses for the quarter increased to $13 3 million as compared to $7 $7 million in the prior year quarter.
This increase was primarily related to the continued progress of the ongoing precision one trial and the build out of the R&D organization.
Selling general and administrative expenses for the quarter were $11 8 million compared to $10 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 the commercial launch of <unk>.
Net loss for the quarter was $18 million compared to $18 3 million in the prior year quarter.
The prior year net loss included the $3 $7 million noncash impairment charge related to the <unk> license agreement the company's predecessor <unk>.
For more information on our financial performance for the quarter a detailed discussion of the results reported on this call will be provided in our Form 10-Q.
As I stated earlier, we are pleased with our overall progress and we're truly excited about what lies ahead.
We continue to enroll the precision one trial and are looking forward to sharing further information on our progress before the end of the year.
We're excited about our new programs and endometrial cancer and nuts and the prospects for our next generation <unk> inhibitor in these indications with meaningful patient populations and high unmet need.
We can now open the line for questions operator.
Thank you.
As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile the Q&A roster.
One moment for our first question.
Okay.
And our first question will come from Joe Canton of zero.
Your line is open.
Hi, everybody I appreciate you taking my questions here I have a couple of maybe the first one on the precision one interim can you just remind us whether that data cut is triggered once these 40 patients have reached a minimum follow up period and if so whats the minimum required follow up there.
I think I heard you right it but just wanted to confirm that these interim data will be reported on just the investigator based assessment.
And there will not be a central review at this point in the study.
Thanks.
Yes.
Hi, Joe Thank you for your questions.
Yes, Youre correct these will be investigator responsive.
And they will not be subjected to IBM Z review.
So I think that was your first question and then the minimum follow up we are attempting to provide six months of follow up.
On <unk>.
Most of the patients a few will fall short I think the shortest follow up we will have might be about four five months.
Does that help yes got it that's super helpful. And then just a follow up.
For the next study.
Sounds like the strategy there.
Generate a data set that maybe potentially point to superiority over ever alignments, and then you'd maybe look to get that publish and that included in guidelines I guess am I correct, there and if so what's the scope of the potential data set you think you would need to generate to pursue that route.
So Joe I think you I could not have stated strategy better than you just did.
We don't need huge numbers.
We are.
Planning to do a relatively small Simon two stage study I'm not going to share the exact numbers, but it will be a relatively small number initially we will look to see if response rate is improved because as you know.
The oral wrap logs are associated with very low response rate and we believe that our superior pharmacology.
Will will.
We will actually show markedly superior.
Response rate, if we see a signal in the first small subset of patients we will be prepared to expand the study.
To a larger number.
I hope that helps.
Okay.
That's helpful. Thanks, So much for taking my questions you are most welcome.
And one moment for our next question.
One woman.
And our next question will come from <unk> <unk>. Your line is open.
Good morning, Congrats on the progress in this quarter a couple of questions for us as well I'll follow up on the next study and Laura So based on your remarks. It sounded like you are not necessarily looking at TSB want to our.
Our approach here. So just curious if you could provide more color there what would be good.
The case Shiller patient population that you will be looking at in prior therapies and anything you could share with us that you have them yet.
You are quite correct and good morning, it's always good to hear from you.
Right.
The.
TLC one two does not play a significant role in the next study in point of fact.
As long as precision that precision trial is enrolling we will not permit patients with GSE, one or two mutations onto the next study. So this is intended to be a.
Not a precision medicine study this is <unk>.
More of an old timey.
All comers.
Functional nonfunctional nets.
We are looking for response rate in that population to differentiate.
Brought out in the previous question.
To differentiate from the.
The data in the literature regarding.
Oral wrap logs.
A very low bar and we think it will be relatively easy.
For us to show.
Show a benefit on the basis of our.
Superior pharmacology.
Thank you all right that's helpful and my other question is on the precision one given that you expect enrollment to complete in the spring 2024, what would it mean for the top line data analysis or are we still on track for first hustle.
Next year for data readout, and what should we expect for that top line data early thoughts.
Well I don't think anything will have changed we anticipate completing enrollment by end of first quarter and then as the data mature we will report out.
<unk> results as quickly as we can.
I can't commit to an exact timeline because we have to see.
We have to see how long it takes but you can do the math and if.
We have six months of follow up on the last patient in by end of first quarter.
You can see that.
Probably anticipate having something to report out by end of year early next year.
Okay. Thank you and my last question is for Scott.
We are your.
Market penetration is there anything you could communicate with us Scott Ginn, how much growth should we expect for the subsequent quarters.
Yeah. Thanks, Thanks for the question.
Haven't shared market penetration information I would say that we're continuing to be really pleased.
Withheld.
How <unk> is doing in Tacoma and with what we're hearing from physicians I think as far as.
What to expect as we move out from a growth perspective, you saw that we had.
Up 6% in this quarter, we had actually in the quarter had a strong April and May and followed by a little bit of a softer Jan.
Yes.
Yes that would be for a number of reasons, we actually saw a similar situation actually last year and what was the first full quarter of launch site.
No not really able to guide on what we'll see for the back half of the year, but I think we continue to be a really positive with how the launch has gone and I think continuing as I mentioned in my comments continuing to make inroads into first line should bode well for for duration as we move forward.
Thank you very much for taking my question.
One moment for our next question.
And our next question will be coming from Boris Picker. Your line is open Boris.
Good morning, and thanks for taking my questions.
First question on <unk>.
Carl can you comment on what you're actually seeing in terms of duration of therapy and how it compares to what you saw in the clinical development program.
Yeah. Thanks, Thanks for the question Boris I mean, we Havent, we havent shared duration data yet I think we still want.
A little more time out there as I've said previously if you remember when we first launched.
And Ah patients coming out of the EAP and then also no.
Approved therapy out there we were kind of getting patients where they were in their patient journey. So a lot of later line patients I think as we continue to move more into the first line, which we've seen happen in the first half of this year I think that should bode well as I mentioned for duration I think we'll have a better read in the coming quarters.
Great and my second question is on precision one alright. Thank you mentioned Theres 15 indications enrolled I'm curious are there any predominant indication that you're observing.
Maybe endometrial or something else.
Hi boards, it's Loretta.
We are seeing.
It probably wouldnt surprise you what we're seeing we're seeing.
Most patients from the most common tumors.
And what I can tell you is.
The G y and tumors as a group ovarian endometrial.
Our one <unk>.
Larger subset.
Bladder, which is urinary bladder, which would not be surprising because it's been the one where we see the highest number of mutations and TFC one.
Is also a player.
We see a smattering of Sarcomas.
Sarcomas are interesting we have a small group of Leiomyosarcoma and then we see.
Osteo one one is everything.
So I would say that as a group we see the largest focus is G y N, but not specifically endometrial as you suggested but.
Different types of G y and tumors mixed and we also see a theme.
There are a number of Gi tumors pancreas gallbladder.
Hepatic cellular.
That's another.
Fairly large portion of.
Tumors, so I would say that we pretty much follow where we're now seeing lung as well in the beginning we didn't see much long long is now starting to come up as.
One of the more common types. So I think what we can say is that we are following.
Following the usual pattern of commonly observed tumors.
Does that help.
Yes, thank you very much for that.
Answer and thank you for taking my questions.
And one moment for our next question.
Our next question will be coming from Roger song Roger Your line is open.
Great.
Thanks for taking my question.
That's for that.
Progress.
The first question, maybe it related to the expansion strategy.
Seemingly you're moving towards.
Some of the validation from prior.
<unk> inhibitor, maybe psychology based trial.
You said more traditional trial just curious.
Anything you will continue.
For fire for the precision oncology wrong.
Mike.
Yes.
Specific mutation on genetic mutation beyond that yet you're one or two may be suitable for farah.
Okay.
Roger Thank you that's a really interesting question.
I think that we will take direction as you know one of the exploratory.
Analyses that we will perform on the precision <unk> trial is to look at common mutations.
At the moment.
The only other targeted therapy that we're combining with a courses.
The moratti compound.
And then there are data to suggest that.
Those two mutation targets seem to work well.
And I think that.
Looking forward.
We would we would have a very rich dataset from precision one to help us identify other potentially important co mutations.
That contribute to efficacy so I think right now.
The answer would be no, but future forward.
Link, we will be opportunistic and follow the data.
Yes that makes sense, maybe just a quick follow up.
I understand that the mutation maybe looking quarter commutation.
Any other biomarker strategy, you will potentially to implement even in those traditional histology based trial, maybe more better for a thorough thank you.
At the very low at this very moment I think we've kind of got a full plate. So I don't think we would be.
Taking on an additional study, but we continue to look very aggressively at.
Other combinations.
Both precision medicine and.
Standard chemotherapy immunotherapy, we are we are always looking for opportunities to.
Expand the potential of our compound.
Excellent. Thank you maybe just last one for the ECC and <unk>.
That study.
Would you be able to guide a little bit about the initial data we can start to see thank.
Thank you.
Well the first patient is in both studies are anticipated to begin enrolling in this calendar year.
So I would anticipate.
Since they are two stage studies that we should have something to report out.
Even early data.
Probably sometime next year.
Great. Thank you Laura Thanks for taking the question that's your polymer okay. Thank you.
I would now like to turn the conference back to Scott Shea Cabello for closing remarks.
Okay, great. Thanks, everyone for taking the time to join our call today as you can see we've got a lot going on and we're looking forward to updating you as the year progresses.
This concludes today's conference call. Thank you for participating you may now disconnect.
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