Oncternal Therapeutics Inc. Q1 2023 Earnings Call
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Greetings and welcome to the Arc tunnel Therapeutics first quarter 2023 financial results call.
At this time all participants all participants are in a listen only mode.
A question and answer session will follow the formal presentation.
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As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host Richard Vincent Chief Financial Officer.
Thank you Joe.
Good afternoon, everyone and thank you for joining US today joining me on the call. This afternoon are our president and CEO , Dr. James Reitmeier, and our CMO, Dr Saline yards Chi.
Today's call includes a business update and discussion of our first quarter ended March 31, 2023 financial results that were filed earlier today, which will be followed by Q&A.
Today's press release and a replay of today's call will be available on the Investor Relations section along tunnels 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.
The 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 may four 2023.
We undertake 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 Meyer.
Thank you rich and good afternoon, everyone.
And then internally, we are advancing our focused and robust product pipeline with clinical and preclinical product candidates that target cancers for patients with unmet medical need.
We recently announced a strategic re prioritization to focus on advancing our <unk> targeting cell therapy.
808.
And our novel dual acting <unk> inhibitor <unk> three four towards significant clinical catalyst within the next 12 to 18 months.
At the same time on April <unk>, we decided with our phase one two and phase III studies of <unk> in combination with Ibrutinib due to major shifts in the Bruton tyrosine kinase inhibitor landscape.
Which was followed by an announcement by our partner of their plans to withdraw a bruton into FDA accelerated approval in mantle cell lymphoma.
This decision allowed us to extend our expected cash runway into 2025 and reinforces our mission to address important unmet needs for patients with hematologic malignancies and prostate cancer.
Looking to the future. We are very excited about the clinical potential of our <unk> targeting autologous car T data way, which is being investigated in a recently initiated phase one two clinical trial.
<unk> Leverages, our extensive clinical experience with <unk>.
Zillow better Nab, which was found to be safe and several phase one and two studies.
That's sufficient for tumor cells is also driven by data from clinical testing of Zillow Bergen map, but don't.
And antibody drug conjugate using the same targeting antibody, which has shown that <unk> can be targeted without unwanted off tumor on target activity.
Our preclinical model show robust and specific cytotoxic activity of <unk> against Roar, one expressing Charles from multiple tumor types.
Our manufacturing process is reproducible scalable and only eight days in duration.
As previously guided we expect our initial clinical data readout in late 2023 with additional clinical data Readouts in 2024.
Our <unk> 101 phase one two study will enroll patients with relapsed or refractory aggressive b cell lymphoma, including those who have failed previous CD 19 car T therapy.
In phase one increasing doses of arc <unk> car T cells will be evaluated to help us determine the recommended phase two dose using a standard three plus three dose escalation design.
The starting dose will be one times 10 to the sixth car expressing T cells per kilogram and this dose has potential to exert anti tumor effects considering other car T products can be effective at similar doses.
Phase two of the study will investigate the recommended phase two dose using a Simon two stage design, which will help us to further evaluate the safety and efficacy of our data away.
As a reminder, patients who have failed CD 19 treatment have extreme unmet medical need with little likelihood of responding to the next treatment and median progression free survival of only three months and overall survival of only five months.
Yeah.
We are also very enthusiastic about our novel and first in class dual action androgen receptor.
Inhibitor arc 534, which both inhibits <unk> activity and induces its degradation.
We have now concluded IND, enabling studies and we are assembling the IMD and are on track for submitting it in mid 2023.
Preclinical model suggest activity directed to both the end terminal and ligand binding domains of the <unk>.
Sure.
I'm $5 34 is active against preclinical models of the most common forms of resistance to standard current standard of care <unk> directed therapies, including <unk> amplification L. B D mutations and AAR splice variants that are constitutively active.
Even though lacking the L D D.
Our phase one two clinical trial in patients with metastatic castration resistant prostate cancer, who are resistant to <unk> inhibitor treatment is expected to open shortly after the IND is cleared.
We expect to present initial clinical results in mid 2024.
We now turn the call back to internal CFO rich Vincent.
Thank you Jim.
Our revenue is currently derived from research and development grants from the NIH.
Grant revenue was <unk> 2 million for the first quarter ended March 31 2023.
Our total operating expenses for the first quarter were $12 3 million, including $1 9 million in noncash stock based compensation expense.
<unk> and development expenses totaled $9 million and general and administrative expenses totaled $3 3 million.
Net loss for the first quarter was 11 5 million or a loss of <unk> 20 per share basic and diluted.
As of March 31, 2023, we had approximately $58 7 million shares of common stock outstanding and 54 point $5.3 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 to recap again, we remain on track for unpaid await our <unk> autologous car T. We expect to report initial clinical data by the end of 2023 with additional data Readouts in 2024.
Franck $5 30 for our lead product candidate.
We expect to submit 90 with the U S. FDA in mid 2023, and we expect to initiate our phase one two study in the second half of 2023 and to present initial clinical data in the first half of 2024.
Now I will turn the call back over to Jim.
Thank you rich.
We are very enthusiastic to be focusing our efforts on these two programs for patients with lymphoma, and prostate cancer, who have such high unmet unmet medical need where we believe our product candidates can make the greatest difference for patients.
With that I will turn things back to Joe for the Q&A portion of this afternoon's call.
Thank you.
And gentlemen, if you would like to ask a question. Please press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue you.
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One moment, please while we poll for questions.
Our first question comes from the line of hard Taj Singh with Oppenheimer. Please proceed.
Great. Thank you.
Thanks for the updates.
Jim.
And team and again those are very hard decisions I'm sure you had to make.
And.
The company, a little bit stronger going forward.
Environment, a couple of questions one is.
Just on the experience you have to deal with <unk> antibody.
Of course.
You have had expenses Alberta.
Mark.
<unk>.
Bought that that ADC, but how does experience with the buyer of that antibody help you with rare or <unk>.
<unk> 808.
And then.
In terms of how that helps your dosing.
Profile going forward for the trials, you're initiating how does that help and I just I just got a couple of quick follow ups after that.
Sure Hi touch so.
So zillow Vernon Nab is the binding domains of she's I've.
We're going to have are what we're using is that as the targeting moiety on the car T. So we do know now from.
Treating a lot of patients with <unk> with the whole antibody that that we can target a roar one.
Are you using using an antibody targeting exactly that way with a with a very encouraging and safe toxicity profile.
Another another thing that this does he loves her to map offers is if a patient is getting into trouble with excessive activation of T cells.
That we could infuse this isla Verde math antibody and.
We've shown in vitro that that can.
Cool off the cytotoxic reaction and so we think that it might be able to serve as an emergency off switch.
And then then the the relevance of the ADC experience since it's also using zero burden that is that the toxicities without ADC were typical for them.
That class MMA antibody drug conjugates without any apparent toxicity, suggesting that other oregon's were damaged through <unk> targeting.
Great Jim. Thank you and then just in terms of what's the dosing level youre going to start out if.
If you can.
Give us some specificity there and then again you know how.
Adding a binder on your car T that you've already had experience with it through the antibody.
How does that help you as you go through your dose titration phase of her trial.
So so we proposed to the FDA and they agreed that we would start at 1 million car expressing cells per kilogram. So that means for an average adult that we'd be giving 60 or 70 million car T.
The reason that that's exciting for US is if there are car T out there where that kind of a dose is associated with substantial efficacy.
We also proposed to escalate.
With with with US a fairly.
Fairly quick escalation scheme, and so we will be moving up in doses every time based on three plus three rules, which you are familiar with and so the that was the the increasing doses will be monitored by a safety review committee, who will make the decision.
And to move from one dose to the next and so so we're starting we're starting at a at a good dose that's what's exciting about it and then we will move up and find the right dose during phase one.
Great do you mean, sorry.
Last question for me is.
Your initial data readout by the end of the year I know, we're always asking for more.
As analysts, but you know if you can just give us the contours of what that looks like I mean, you think you could have a few patients five to 10 patients more than 10 patients and then what are you looking for a response and some duration or just response.
Any thoughts there thank you.
Sure Hi, Josh so for this year.
Two patients.
And our initial our initial.
Response and early early durations so.
It was it's not likely to be much more than that as you. As you know FDA is wants to be conservative in the early going in a clinical trial and so the way.
They've asked us to have a 30 days between each patient that is treated.
Great. Thank you Jim Thanks for all the questions.
Alright.
Our next question comes from the line of Carl Byrnes with Northland Capital markets. Please proceed.
Great. Thanks for the question I think.
Most of my questions have been answered here, but just.
Just going back to 808, if I recall correctly, the subject of one and two they are eligible for bridging therapy in those.
Segment is that correct.
Yes, that's correct, Carl and but with our bridging therapy is sometimes needed when there's a there's a long period of time, where patients are waiting to get their car T product. So one of the things were.
Very enthusiastic about that our with our car T manufacturing goes pretty quickly. It's an eight day manufacturing process and so we're hoping that our that our patients most likely to need bridging therapy.
Great. Thanks very helpful.
Our next question comes from the line of Lee what sick with Cantor Fitzgerald. Please proceed.
Hi, there thanks for taking our questions. This is Rosemary we actually watch it.
Firstly about 808 could you give us a sense of her enrollment is tracking and where you might be in terms of dose escalation and then four of 534 would you be able to guide anything about the bar of success or the phase one question. Thank you.
Thank you Rosemarie.
So so we're not going to talk specifically about enrolled numbers, but we do believe as hard times you asked that we'll have data on a few patients.
By the end of the year.
Selim would you Celine Yanji, our CMO Ken answered the question about the bar for prostate cancer in phase one.
Yes. Thank you Jim and thank you for your question Rosemarie, Yes, I think what we're trying to do here specifically in the phase one and we are using.
You know very well known boring design.
To get to the therapeutic dose.
As fast as possible.
And the phase one I think PSA reduction. This is what we're looking for as a primary market for antitumor activities and I think this is what we would be looking for of course, we're going to look into other surrogate markers.
Markers, including CFS.
That's us.
Got it thank you and I'll add Rosemary that the patients will have failed standard of care androgen receptor.
Signaling inhibitors, like <unk>, and abiraterone and so a hormone based.
A treatment for patients after that yields very low response rates probably.
The 15% range. So so if we see something in the 30% to 40% range for these patients with advanced disease will be we'll be very happy.
Great. Thanks, so much.
Our next question comes from the line of Oliver with Brookline Capital markets. Please proceed.
Okay.
Thank you.
Question about Zillow, Verona, Mab and potentially.
Pivoting towards the other be Teekay is based on additional preclinical work I know, it's only been about a month, but do you have any further thoughts on.
That process and.
How it shakes out and the priorities are.
The pipeline at this point.
Yes, good question camp so.
Of course.
The decision by Abbvie to.
Withdraw its FDA accelerated approval of eat Bruton for mantle cell lymphoma was a was a blow to our plan for registration in that in that indication with a group now.
And so we are talking to other V TK inhibitor companies.
And there is some interest here and we are of course.
I'm.
Interested in generating additional data, we do believe that Zillow virden map will be synergistic with all of the approved PTK inhibitors.
And mechanistically at least expect it to be synergistic with others that are still in.
Earlier stages of development. So short answer is that we're keenly.
Keenly interested in another.
Another T K.
Inhibitor as a potential path forward.
And I guess, it's too early to give any thoughts on the time table.
It's too early.
Okay fair enough. Thank you.
Thank you good question.
Yeah.
Thank you ladies and gentlemen, there are no further questions at this time I'd like to turn the call back to Jim Meyer for any closing remarks.
Thank you all for your time and attention today, we look forward to reporting our initial clinical data from 808, <unk> targeting Untangled autologous car T. In patients with lymphoma, who have failed CD 19 car T treatment and for Entre 35, 34, our novel first in class.
Dual action.
EBITA for metastatic castrate resistant prostate cancer patients, who are refractory to current AAR inhibitor therapies.
Thanks, again for joining us and we look forward to updating you during upcoming medical and banking conferences.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
Yeah.