Q3 2023 Oncternal Therapeutics Inc Earnings Call
Greetings and welcome to our terminal Therapeutics third quarter 'twenty to 'twenty three financial results Conference call.
At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
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Please press star zero on your telephone keypad.
And mind you. This conference is being recorded I would now like to turn the conference over to your host Mr. Richard Vincent Chief Financial Officer. Please go ahead.
Thank you Rob good afternoon, everyone and thank you for joining us today join.
Joining me on the call. This afternoon are our president and CEO, Dr. James Brett Myer, and our CMO Dr. Celine the Asti.
Today's call includes a business update and discussion of our third quarter ended September 32023 financial results that were filed earlier today.
<unk> press release, and a replay of today's call will be available on the Investor Relations section of our internals website for at least the next 30 days.
Please note that certain information discussed on today's call is covered under the safe Harbor provisions of the private Securities Litigation Reform Act.
We will be making forward looking statements during this call about future events, such as our business and product development strategies.
Timing of initiation of our preclinical and clinical studies.
Timing of planned interim data updates.
The timing of our regulatory filings and our cash runway.
Our actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with our business.
These forward looking statements should be considered in conjunction with and are qualified by the cautionary statements contained in today's press release, and our SEC filings, including our Form 10-Q filed today and our previously filed Form 10-K for the full year ended December 31 2022.
This call contains time sensitive information that is accurate only as of the date of this live broadcast November nine 2023.
<unk> undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances occurring after the date of this call.
With that it is my pleasure to hand, the call over to our CEO Dr. Jim Reitmeier.
Thank you rich and good afternoon, everyone and thank terminal. We are now advancing two first in class clinical programs targeting cancers for patients with significant unmet medical needs.
In October 2023, we dosed, our first patient in our phase <unk> dose escalation study of arc five three for our novel dual action androgen receptor.
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<unk> hundred 34 as for patients with metastatic castrate resistant prostate cancer, who have progressed after treatment with approved <unk> pathway inhibitors.
In October we also received fast track designation from FDA further supporting our belief that arc five three for may be an important therapeutic alternative for patients with advanced prostate cancer. We expect our initial clinical data readout in the first half of 2024.
With respect to <unk> 808 hour <unk> targeting autologous car T program, we continue to execute on enrollment of the phase one two study and aggressive b cell non Hodgkin's lymphoma patient.
We have now dosed the first few patients and plan to announce initial clinical data in December of this year with additional clinical Readouts in 2020 for the.
The manufacturing process is delivering large numbers of high quality car expression T cells and may offer reduced vein to vein times.
Overall, we are delivering on our plan to advance our two clinical programs.
34, 808 through potential significant value inflection points.
The first half of 2024.
All while maintaining our cash runway guidance into 2025.
With that I'd like to now turn the call to alternative CMO, Celine <unk> to expand on our clinical progress with $5 34 and 808.
Jim.
Thank you Jim.
As Jim mentioned, we are excited to have dose to have dosed. Our first patients in the study of <unk> hundred 34, <unk> hundred one a phase <unk> dose escalation study, that's enrolling patients with metastatic castration resistant prostate cancer was progressive disease that have relapsed or are refractory to prior androgen receptor pathway inhibitor.
<unk>, such as <unk> automotive channel.
Based on preclinical studies and its novel mechanism of action. We believe <unk> 534 can provide an important treatment alternative disease patients by addressing a key tumor escape mckinnon.
Results in resistant to Kieran clear available <unk> pathway inhibitors, including <unk> mutation <unk> amplification and splice variants such as they are.
At the center.
Enrollment is advancing according to plan and we continue to expect to report initial data in the first half of 2024.
In September we announced the establishment of our prostate cancer Scientific Advisory Board.
Which includes distinguished academic and industry leader in the prostate cancer field, such as professor Johann de Bono from the ICR and London, Dr. Matthew Smith from Mass General Industrial Avenue from the Fred Hutch.
We look forward to working with our SAP to develop our future clinical registrational strategy for 534.
With respect to <unk>, our autologous <unk> targeting car T. We continue to dose patients in <unk>.
The dose escalation portion of our study.
101, a phase one two studies for patients with relapsed or refractory progressive aggressive b cell lymphoma.
Including those who have failed previous CD 19 car T therapy.
We have seen encouraging expansion and persistence of car Express Inc. T cells in the study.
Which has been demonstrated to be positively correlated with clinical response, and PBS CD 19 car T studies.
With this I'll now turn the call to our CFO rich fences rich.
Thank you Celine.
Revenue is currently derived from research and development grants received from the NIH.
Grant revenue was <unk> 2 million for the third quarter ended September 32023.
Our total operating expenses for the third quarter were $10 6 million, including $1 7 million and noncash stock based compensation expense.
Research and development expenses totaled $7 5 million and general and administrative expenses totaled $3 1 million.
Interest income for the quarter was <unk> 5 million.
Net loss for the third quarter was $9 9 million for loss of 17% 17 per share basic and diluted.
As of September 32023, we had 59 million shares of common stock outstanding $43 million in cash and investments and no debt.
We believe these funds will be sufficient to fund our operations into 2025.
With respect to upcoming milestones we remain on track.
<unk> eight O H <unk> autologous car T. We expect to report initial clinical data in December 2023, with additional data Readouts in 2024.
534, our <unk> product candidate, we expect to present initial clinical data in the first half of 2024.
Now I will turn the call back over to Jim.
Jim.
Thank you rich.
We are very pleased with the recent progress in our two clinical programs, while reiterating our cash runway guidance into 2025.
We are excited to be advancing the clinical development of novel pathways in areas with very high unmet medical need such as CD 19, relapses in aggressive lymphoma, and metastatic castrate resistant prostate cancer harboring <unk> mutations and splice variants.
Thank you for joining us today, and we look forward to updating you during upcoming medical and banking conferences with that I will turn things back to Rob for the Q&A portion of this afternoon's call.
Thank you.
At this time, we will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.
A confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue.
Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
My first question is from Carl Byrnes with Northland Capital markets. Please proceed with your question.
Thanks for the questions and also congratulations on your progress I'm wondering if you can provide a little more detail with respect to the velocity of patient recruitment.
34 dose escalation study and this is obviously considering the urgent unmet medical need as indication.
And then I have a follow up.
Go ahead Celine.
Yes so.
As you know we designed the study based on the <unk> design, which is allow us to move forward was the first two cohorts was only one patients each.
No.
Texas city or side effect during those cohorts.
So so far I mean.
Enrollments have everything goes as expected.
And Karl there are a lot of these there are a lot of these patients out there.
Yes, that's right.
It seems like these trials as you progress and advance.
<unk> be relatively easy.
To calculate <unk> role.
Hi.
We hope so.
For now, but what we're finding is that our both studies investigators are enthusiastic.
The number of patients.
Who are in their systems with these kinds of unmet need seem to be ample for our for good enrollment pattern.
Excellent and then just shifting gears a little bit on eight away do you have any any thoughts there in terms of the potential efficacy signal with the data readout in December considering the dose I believe relatively close to recommended phase two doses of other car T therapies.
Okay.
Yes, I'll take that one so I think that.
As you probably know with aggressive lymphoma.
Responses to car T.
Pretty quickly.
And.
Hello.
<unk> car T.
Median time to.
I suppose the one to launch so.
Yes.
Hi.
Similarity between Mis.
Ms Tina.
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Right.
Okay.
I'm, sorry, Jim I think you broke up a bit.
Yes, it did I am sorry.
Can you can you hear me better now.
Yes, yes, yes.
Okay.
Which funds.
So so.
Given given that other car T programs.
As shown the complete responses can develop quickly.
We are optimistic that we may have some efficacy to talk about it in December.
Great Great again, congrats congratulations on the progress.
Our next question comes from hard harsh thing with Oppenheimer <unk> Company. Please proceed with your question.
Great. Thank you thanks for that a couple of questions and really nice update.
Things are moving along pretty quickly Jim and team.
19.
Yes on Italy.
One question there is falling off.
The previous question.
What would you like to see.
Whether it's dose level, one two or three.
A minimum amount of efficacy.
In order to move forward.
Then when you do move forward are you thinking about dose expansion what are we thinking in terms of what would be an acceptable durability that you'd like to like you'd like to see as you saw followed these patients onwards.
And then on the other program with $5 34.
Again, just similar questions you're going to have a lot of data being presented there.
Early stage.
What should we be looking for.
That signals to us that you are getting close to a sofa move into dose expansion from the dose escalation part of the script. Thank you.
Jim do you want me to.
Okay. So if I.
I can start is actually.
Jim probably publishing the connection.
As you know we really.
Dealing with very.
Sick patients, especially patients who are relapsed.
Collapsed from prior year, CD 19 car T.
Unfortunately, I mean, you know.
These patients the progression free survival and overall survival is very short.
Usually in months is not that <unk> bin.
Yes.
And what we would expect we would expect to see some objective response and also durability of response and that's a big question.
What will be good as a durable response in those patient populations. That's already failed prior car T. I think I think it's a very.
A very objective question and we need to.
Still see some of that data and evaluate it because usually.
Median progression free survival, there is no more than three months.
Currently in the survival data is no more than six months. So I think we are really.
Dealing was very aggressive and very sick patients, but when we hoping for the best So I'll stop here I don't take any question if there's any additional ones from me.
No that's really good and then just on slide 34.
How do we.
I guess, what do you expect to see I mean, you've got all the we can go to 600 milligram oral daily right. It seems like.
And but.
When do you where do you think you could you could get to before you would expect DLP and if you need to go all the way to 600 and think it could be before that and thanks for the question.
So I think I think it's just it's just also.
It's all depends I mean, you know.
On the dose escalation and how fast we can go there.
But we will we will actually believes that's a therapeutic dose or the efficacy boost maybe start from the 300 above.
Which is that would be the fourth cohort, we may start seeing things earlier than that and we hope to do that.
I think.
Time will will actually will be on our side. So it will be able to see any early responses in earlier cohorts.
And let me, let me add something.
Yes, yes, yes. So there was a there was a very interesting panel discussion at the Citi Conference last week, where several members of the FDA.
Dressed.
Project Optimists.
And what what what they made clear and simple.
Emphasizing what's in the FDA guidance here is that FDA is looking for developers to establish.
A balance between efficacy and safety.
And they are not.
They're in oncology.
<unk> in particular.
They're they're they're encouraging.
Early development to learn more than just the maximum tolerated dose and to explore doses below MPD to look for that.
Perfect balance between between efficacy and safety and so this was what was particularly helpful. About this panel was that it was being discussed in the context of cell therapy, such as 808.
But at the same principles will apply to the choice of dose for <unk> four as well.
Yeah and Jim.
I guess I.
Just thinking.
No you've probably mentioned this before just remind US again, why do you have to dose levels dose levels and dose that will be when you move forward from the dose escalation part of the study.
Yeah.
It's exactly for that reason hard Taj.
It's what FDA is looking for.
And this project Optimus and and they they made it clear that whenever possible. They expect to see randomization between the two dose level. So that by the <unk> before you start a registration intent study FDA will have the opportunity to.
Salmon epic epic epic efficacy and safety and risk benefit ratio for more than one dose.
Yep.
This is all very helpful. Thank you for the question.
Thank you.
Our next question comes from Camp Oliver with Brookline Capital markets. Please proceed with your question.
Okay, great. Thank you.
So the question relates to.
The $5 34 and <unk>.
Novartis recently presented.
Data from P SMA for.
Which as you know is the pre taxane setting and.
We are.
<unk> data any day now from.
The Splash trial, which is also in that same patient population.
<unk> on what you've seen so far and the commentary regarding how.
These drugs would be used in that.
Setting how are you.
Are you thinking about.
The opportunity for 534.
Yes, good question Kim.
The challenge from the <unk> four study.
Is that there is a.
Slightly worse overall survival in the active treatment group and the intent to treat analysis and so we know that FDA will be looking at their safety safety data.
In a in a in a very close manner.
What we what we believe is that there is still a very high.
Desire for both the patients with prostate cancer and their physicians to have another treatment option available.
An oral treatment.
The option available it doesn't require referral to a different specialists.
To treat after resistance to and dilutive monitor abiraterone develop so we're remaining confident that we have a commercially viable and clinically important.
Indication here in the prostate cancer continuum.
Got it thank you.
We have reached the end of the question and answer session I would now like to turn the call back over to Dr. James Brighton Meier for closing comments.
Thank you Rob.
We appreciate everybody's time and attention and good questions. This afternoon.
Looking forward to an exciting end of this year and first half of next year and look forward to staying in touch with you. So with that thank you for your time and we will sign off.
This concludes today's conference you may disconnect your lines at this time and we thank you for your participation.
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