Oncternal Therapeutics Q2 2023 Earnings Call Transcript

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Provided by Quartr
August 10, 2023

There are 8 speakers on the call.

Operator

And welcome to the OncTernals Second Quarter 2023 Financial Results Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. And it is now my pleasure to introduce to you Richard Vincent, CFO.

Operator

Thank you, Richard. You may begin.

Speaker 1

Thank you, John. Good afternoon, everyone, and thank you for joining us today. Joining me on the call this afternoon are our President and CEO, Doctor. James Bretmeyer and our CMO, Doctor. Selim Yazgi.

Speaker 1

Today's call includes a business update and discussion of our Q2 ended June 30, 2023 financial results that were filed earlier today. Today's press release and a replay of today's call will be available on the Investor Relations section of OXXTERNAL's 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, The 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.

Speaker 1

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 are previously filed Form 10 ks 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, August 10, 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, Doctor.

Speaker 2

Thank you, Rich, and good afternoon, everyone. At Nocturnal, we are now advancing 2 clinical stage programs targeting cancers for patients with significant unmet medical needs. Last week, Octernal announced that we received a Study May Proceed letter From the U. S. FDA for the Phase onetwo dose escalation study of ONC-five thirty four for patients with advanced prostate cancer.

Speaker 2

FDA's review of the IND application was completed before the standard 30 day review period and our study start up Activities are tracking ahead of schedule. With that, we expect to initiate our study in the Q3 and expect our initial clinical data readout In the first half of twenty twenty four. We are very excited to bring ON-five thirty four to patients suffering from advanced As a reminder, our preclinical study results suggest that ONC-five thirty four is active against the most comment androgen receptor aberrations that drive tumor resistance to currently approved AR signaling inhibitors such as Xtandi or ZYTIGA. Our CMO, Selene Yajji, will provide more details about the study design and ramp up plans in a moment. With respect to our ROR-one targeting autologous CAR T, ONT-eight zero eight, We are very pleased to report that the first patients have now been dosed and that enrollment is meeting or surpassing our expectations.

Speaker 2

We believe ONK-eight zero eight may be a best in class RAR-one CAR targeting CAR T as it builds on our extensive clinical experience with zilivertimat, which was found to be safe in several Phase 1 and 2 studies. Preclinical models show robust and specific cytotoxic activity AVANT-eight zero eight against ROR1 expressing cells from multiple tumor types. Clinical manufacturing runs completed to date Continue to support our thesis that our manufacturing process is robust, reproducible, scalable and shorter than several approved CAR T therapies. We continue to expect to announce some initial clinical data in late 2023 with additional clinical data readouts in 2024. Let me now turn the call over to OncTernal's CMO, Salim Yajji, To expand on our clinical plans for ONKY-five thirty four and our progress with ONKY-eight zero eight.

Speaker 2

Selene?

Speaker 3

Thank you, Jim. Good afternoon, everyone. As Jim mentioned, now that our IND for ANK 534 is active, We are working diligently to bring UNC-five thirty four to patients as fast as possible. The study, UNC-five thirty four-one hundred and one is a Phase III dose escalation study that will enroll patients with metastatic Castration resistant prostate cancer with progressive disease that have relapsed or are refractory to next generation androgen receptor signaling inhibitor, including enzalutamide or abrazorone. The dose escalation will use The baseline optimal interval or BEYOND design, which is an effective statistical method To optimally and quickly identify the maximum tolerated dose or MTD.

Speaker 3

Once the MTD is identified, the study will roll into a Phase 2 Timing 2 stage design to evaluate the safety and efficacy of ONC-five thirty four at 2 dose levels. The ramp up to the study start is well underway, and we have already selected the clinical sites That will support initial dose finding portion of the study. The potential of AMG FIGHT34 to address A significant unmet need for patients with relapsedrefractory metastatic prostate cancer has been appreciated by top KOLs An academic institution in the U. S. And Europe, and we are excited to be working with them to advance the clinical investigation of Our novel product candidate.

Speaker 3

Based on this progress, we now expect to initiate the study in the Q3 of 2023 and expect to report initial data in the first half of twenty twenty four. Now switching gears into our ROAR-one targeting CAR T. We recently treated our first patients in the study, UNC-eight hundred and eight-one hundred and one, a Phase III study for patients with relapsedrefractory aggressive B cell lymphoma, including those who have failed previously CD19 CAR T therapy. As a reminder, patients who have failed CD19 treatment Have extreme unmet medical need with a little likelihood of responding to their next treatment and very short, medium progression free Overall, we are very pleased with the rate of enrollment and Look forward to discussing preliminary data by the end of this year. With this, I now turn the call to our CFO, Rich Vincent.

Speaker 3

Rich? Thank you, Selim.

Speaker 1

Our revenue is currently derived From research and development grants received from the NIH, our grant revenue was $100,000 for the Q2 ended June 30, 2023. Our total operating expenses for the Q2 were $9,700,000 including $1,700,000 in non cash Stock based compensation expense. That represents a $2,500,000 decrease from our total cash operating expenses of Approximately $10,500,000 for the Q1 of 2023. That represents an efficient wind down of the activities resulting from our reprioritization initiative that we announced on April 3, 2023. Research and development expenses totaled $6,600,000 and general and administrative expenses totaled 3,100,000 Interest income for the quarter was $600,000 Net loss for the 2nd quarter was $9,000,000 for a loss of $0.15 per share, basic and diluted.

Speaker 1

As of June 30, 2023, we had approximately 58,700,000 shares of common stock outstanding, $45,500,000 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. For ONC-eight zero eight, our ROR-one autologous CAR T, we expect to report initial clinical data by the end of 2023 with additional data readouts in 2024. PRONC-five thirty four, our lead DARE product candidate, we now expect To initiate our Phase onetwo study in the Q3 of 2023 ahead of schedule and to present initial clinical data in the first half of twenty twenty four.

Speaker 1

Now, I will turn the call back over to Jim. Thank you, Rich.

Speaker 2

We are very Pleased with the recent progress as we continue to execute on our plan to achieve significant clinical catalysts for our 2 lead programs, while retaining our cash runway into 2025. With that, I will turn things back to John for the Q and A portion of this afternoon's call.

Operator

Thank you, sir. We will now be conducting a question and answer A confirmation tone will indicate that your line is in the queue. And the first question comes from the line of Carl Burns with Northland Capital Markets. Please proceed with your

Speaker 4

Signal in the Phase 1 portion of the study, I mean, it's obviously considering the MTDs will determine the It will be determined using the incidence of DLTs with I think a timeframe of 28 or so days. And then I have a follow on question.

Speaker 2

So Carl, yes, we do think that a PSA signal is possible. And we are The eligibility criteria were designed to enrich for patients whose disease remains androgen dependent androgen receptor And the mechanism of action would include inhibiting PSA as

Speaker 4

And similarly with 808 and considering the dosing there And the study is close to if not consistent with recommended Phase 2 dosing of other CAR T therapeutics. Do you see a potential for early efficacy signal in that initial data?

Speaker 2

Salim, you want to take that one?

Speaker 3

Yes, sure. Yes, I mean, I think we would expect to have an early signal as well. I mean, as you know, those patients Very hard to treat and after failing especially after failing CD19, prior CD19 CAR T, But we would expect actually to have an early signal and also we would like to see a duration of response Will be actually something that we are very kind of like looking forward to.

Speaker 4

Great. Thanks. Congratulations again.

Speaker 3

Thank you. Thank you.

Operator

And the next question comes from the line of Hartaj Singh With Oppenheimer and Company, please proceed with your question.

Speaker 5

Great. Thank you. Thanks for all the updates. And I got a couple of questions. One is just on 808, following on Previous question.

Speaker 5

If I look on controls.gov, you've got B cell, any gel patients, MCL and then various types of LBCL Patients in there, on your expansion, you're already indicating MCL and I guess LBCL. Dilbertamab, I believe, showed pretty good, really good signal of MCL. So just building on the previous question, I mean, you're close to Recommended Phase 2 dose starting off, can you just kind of walk us through what your dose escalation look like? And then I imagine would those The MCL patients we'd be seeing, I just got a follow-up question after this one.

Speaker 2

Shailene?

Speaker 3

Yes. So, Hertaj, I think what we're trying here to do, I mean, in the beginning, when the dose escalation, We are actually accepting all aggressive lymphoma in the dose escalation. However, in the expansion, I think we would like to Separate like MCL from DLBCL and other aggressive lymphoma type. As of now, we're only going with 2 indication, Which is the MCL and DLBCL. So what was the other question,

Speaker 5

Yes. And just a follow-up to that, Celine, which is that, since this is a CAR T and you're going With your knowledge of zilbertumab at a higher dose, I mean, in terms of just DLTs, should we just expect Something analogous to what we've seen with CAR Ts previously, CRS and other kinds of toxicity?

Speaker 3

Well, it's just yes, go ahead.

Speaker 2

I can take that Selene. So Hartaj, as I'm sure you know, The in most CAR T programs, there's not a there's not as distinct of a dose response curve As there are with other kinds of molecular entities, because the ultimate efficacy has to do with the quality of the We have the type of CAR T construct and process that we're doing Is one that would be expected to see some cytokine release syndrome, for example, But our investigators tell us that you need to see some CRS if your CAR T is doing what you want it to.

Speaker 5

Yes. That makes sense, Jim. Really makes I mean, That makes a lot of sense. And then, at the end of the year, the data would be just a safety update or we'd see some clinical potential efficacy kind of Data also potentially.

Speaker 2

Delaney?

Speaker 3

Yes. So, Hertogen, we would expect to see preliminary data even including some efficacy Data by the end of the year, yes.

Speaker 5

Great. Thank you. Thanks for all the questions.

Speaker 3

Thank you.

Operator

And the next question comes from the line of Lee Watsack with Cantor Fitzgerald. Please proceed with your question.

Speaker 6

Hi, there. This is Rosemarie on for Lee. Thanks so much for Taking our questions. Just a general one first about 534. Can you talk a bit about the changing Landscape in prostate cancer treatment and how you think 534 could eventually fit in?

Speaker 2

Happy to, Rosemary, and thank So, we believe that The part of the landscape where we're sitting is one that has very significant unmet medical need. The androgen receptor signaling inhibitors, enzalutamide, darolutamide, apalutamide and abiraterone Our core therapy and standard of care for virtually every patient In the early portion of treating metastatic disease and at the time that Patients become resistant to those agents. Some of them have some of them become androgen receptor independent, And that's not who we're targeting, but a very large proportion of them remain androgen receptor dependent, But resistant to standard AR signaling inhibitors. And so that's a large population and It's in that space between hormone therapies And chemotherapy or radiotherapy, which have much more toxicity. So we think it fits perfectly there to begin with.

Speaker 2

However, we're also showing 534 also has very robust activity with patients who have a native or unmutated androgen And interestingly, have very strong activity in rodent models where the animals were not castrated. And so that is an unusually strong type of activity in the presence of normal testosterone levels That suggests that once we've shown activity in late stage disease that there is a clear pathway to move forward Into earlier stage advanced prostate cancer.

Speaker 6

Got it. Great. Thank you. That was really helpful. And maybe just one quick one on 808.

Speaker 6

So, do you have an estimation for maybe how many patients you could be And by your data update, I know it's going to be really soon after first patient in, but

Speaker 2

Yes. Salim?

Speaker 3

Yes. So you're talking about when we're going to present it by the end of the year, is that what you're talking about?

Speaker 2

Yes. How many AOA patients?

Speaker 3

Yes. So probably would be at least 3 patients with a different time to follow-up.

Speaker 6

Great. Thank you so much.

Speaker 2

You're welcome. Thank you, Rosemarie.

Operator

And the next question comes from the line of Kempe D'Aliver with Brookline Capital Markets, please proceed with your question.

Speaker 7

Hi, thank you. Just quickly to To be sure I understand the landscape with 534. Jim, are you saying that you're thinking this would come in between after first line therapy but before chemotherapy?

Speaker 2

Exactly, Kent.

Speaker 5

Okay.

Speaker 2

Now as you know, there are Some people are using, say, Enzalutamide plus docetaxel as the first treatment for metastatic But this agent would still be suitable after that regimen as well.

Speaker 7

Got it. And what percentage of the patient population do you think would fall into

Speaker 2

So this target that you've set out? Well, we're that's something that we're going to learn in the clinical trial. And we do think that after failing enzalutamide or abiraterone that somewhere Between 1 third and 2 thirds of the patients remain androgen receptor dependent.

Operator

There are no further questions at this time. And I would like to turn the floor back over to Doctor. Breitmeyer for any closing comments.

Speaker 2

Thank you, John, and thank you everybody who listened and for the excellent questions and discussions. We now have 2 active clinical programs, both of which are moving well and both of which will have data in the near term. The entire team is excited to be bringing new potential therapy to patients with advanced and refractory aggressive lymphoma And to patients with advanced and refractory prostate cancer. And hopefully, we will be addressing their high unmet medical need. With that, Thank you for joining us today and we look forward to updating you during upcoming medical and banking conferences.

Operator

Ladies and gentlemen, that does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your

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Oncternal Therapeutics Q2 2023
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