Oncternal Therapeutics Q1 2024 Earnings Call Transcript

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Provided by Quartr
May 9, 2024

There are 7 speakers on the call.

Operator

Greetings. Welcome to Omcturno's First Quarter 2024 Financial Results Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded.

Operator

I will now turn the conference over to your host, Richard Vincent, Chief Financial Officer. You may begin.

Speaker 1

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

Speaker 1

Today's call includes a business update and discussion of our Q1 ended March 31, 2024 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 Nocturnal'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 our clinical studies, planned interim data updates, 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 our previously filed Form 10 ks for the full year ended December 31, 2023. This call contains time sensitive information that is accurate only as of the date of this live broadcast, May 9, 2024. 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. Jim Breitmeier.

Speaker 2

Thank you, Rich, and good afternoon, everyone. At Oncurnell, we are advancing 2 1st in class clinical programs targeting cancers for patients with significant unmet medical needs. ONX-five thirty four, our novel dual action androgen receptor inhibitor or DARE is advancing rapidly through the dose escalation portion of the Phase onetwo study. And we continue to see high demand and engagement from KOLs, investigators and patients. We believe that by interacting with both the ligand binding domain and the N terminal domain of the androgen receptor and by inducing degradation of the AR, ONC-five thirty four may address many prostate cancer escape mechanisms to approved AR pathway inhibitors such as enzalutamide and abiraterone, including many LBD mutations and splice variants such as AR V7.

Speaker 2

We have recently opened several top academic centers to join the Phase onetwo study and the investigators are enthusiastic. We are also happy to announce that the 4th dosing cohort of study is now fully enrolled. Patients in this cohort are receiving 300 milligrams of ARN 534 once per day orally. The decision to move to this dose level was made by the study's safety review committee after reviewing data from the patients treated to date, including those at the 3rd dose level of 160 milligrams on 534 daily. Based on preclinical analyses, we are optimistic that study participants are receiving doses of ONP-five thirty four that may be within active dose range for antitumor activity.

Speaker 2

We plan to share an initial clinical data update for this program late in Q2 of this year. Now switching gears to ONC-eight zero eight, our ROAR-one targeting autologous CAR T, we are also happy to announce that the Phase onetwo study in patients with relapsed or refractory aggressive B cell lymphoma, including patients who have failed previous CD19 CAR treatment, is again open and enrolling patients. We'd like to thank the team and our investigators for the swift implementation of protocol amendments, which include modified eligibility criteria, increased monitoring for infection and evaluating lower doses. As a reminder, we recently shared an encouraging initial response signal at the 1x106 CAR T cells per kilogram dose with 2 of the 3 patients achieving complete metabolic response and the 3rd achieving a partial response as of the December 4 cutoff date. We expect to report updated clinical results, including data from patients treated with the new dosing schedule in mid-twenty 24.

Speaker 2

With this, I will now turn the call back to our CFO, Rich Vincent. Rich?

Speaker 1

Thank you, Jim. Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was $600,000 for the Q1 ended March 31, 2024. Our total operating expenses for the Q1 ended March 31, 2024 were $9,300,000 including $1,400,000 in non cash stock based compensation expense. In the Q1, research and development expenses totaled $6,000,000 and general and administrative expenses totaled $3,300,000 Net loss for the Q4 was $8,400,000 for a loss of $2.83 per share basic and diluted.

Speaker 1

As of March 31, 2024, we had approximately 3,000,000 shares of common stock outstanding, dollars 27,000,000 in cash, cash equivalents and short term investments and no debt. We believe these funds will be sufficient to fund our operations into the Q1 of 2025. With respect to upcoming milestones, we remain on track for both programs moving forward towards significant data points. For ONC-five thirty four, our lead DARE product candidate, we expect to present initial clinical data in the latter part of this Q2 of 2024 with additional readouts in the Q4 of 2024. BRONC-eight zero eight, our RORA-one autologous CAR T, we expect to report a clinical data update in mid-twenty 24 with additional data readouts in the Q4 of 2024.

Speaker 1

With that, I will turn things back to the operator for the Q and A portion of this afternoon's call.

Operator

Thank you. At this time, we will be conducting a question and answer session. Our first question comes from the line of Karl Byrnes with Northland Capital Markets. Please proceed with your question.

Speaker 3

Thanks for the question and congratulations on your progress. With respect to 534 in terms of the 300 dose in the dose escalation study, do you expect to get I think you mentioned that you had full enrollment of that cohort. How many were in that cohort? And then also would you suspect that you would go to the higher 600 milligram dose prior to the mid year end update? Thanks.

Speaker 2

So we'll have Salim answer that question.

Speaker 4

Yes. So actually, we already fully enrolled and dosed this cohort, 3 patients in this cohort. We're still in the DLT period and we expect to have SRC happening mid this month, towards the end of this month actually. And then if everything is fine, we'll escalate to the next dose cohort, which is the 6

Speaker 5

100 milligram?

Speaker 2

Yes. So, Carl, assuming that everything runs on track, we would have some data from the 600 milligram cohort by the time we announce results.

Speaker 3

Great. Thanks so

Operator

much. Thank you. Our next question comes from the line of Hartaj Singh with Oppenheimer and Company. Please proceed with your question.

Speaker 5

Great. Thank you. I just got a couple of questions. One is, again, just going back to prostate cancer. Amatuer receptor signaling the current, when these molecules are given redosed, Jim, it seems with that ARSI after first line, second line ARSI is given you've got about 25% responses, maybe a little bit higher, but that's what the academic literature seems to suggest.

Speaker 5

Is that the way to think about how the update could happen in the second quarter with 534? Is it too early to see data in-depth like that? And then I just got a quick question on follow-up on AROR-one.

Speaker 2

Sure. And I'll take that question. So I think that the published data on switching from one existing androgen receptor signaling inhibitor to another would be at the low end of what we're expecting. Because for example, if you switch from enzalutamide to abiraterone, the failure to respond to the abiraterone includes the fact that mutations in the ligand binding domain have developed that the second agent cannot address. So in our case, we are 534 does is active against, for example, prostate cancer that is resistant to enzalutamide.

Speaker 2

So it would be active in more cases than you would expect from switching from one AR SI to another. We're also active against splice variants, which have lost the ligand binding domain entirely, and those do not respond to conventional hormone related therapies at all.

Speaker 5

Great. Thank you, Jim. And then the other question is just on LORAR-one. Is there any color or updates you can provide on the durability of those 2 CRs that you saw in December? And thanks for the question.

Speaker 2

Sure. Celine, do you want to comment? We're Hartaj has to wait, I know, but you can speak in generalities.

Speaker 4

Sure. So, we're not going to go into the details, but as you know, the patients that we've been treating in the Cohort 1, those patients who failed multiple prior therapy, including prior CD19 CAR T as well as some of them CD79 and bispecific treatment. So they're very heavily pretreated patients and usually the expectation of those patients is very low and short and progression free survival. So to answer your question, I think we are enthusiastic about what we are seeing about the durability of this response. But taking considerations that we have very sick, very heavily treated patients.

Speaker 5

Great. Thank you. Really appreciate that. Thanks for the question.

Operator

Thank you. Our next question comes from the line of Robert Burns with H. C. Wainwright. Please proceed with your question.

Speaker 6

Hi, guys. Thanks for taking my questions and congrats on the progress. Just two questions for me regarding 808. So I know that in the current trial design, it's only Phase 1 in which you're looking at the CD19 failed CAR T patients or those who are ineligible for CAR T, CD9 targeted CAR T. I was curious whether you would also try to explore that in Phase 2 or are you trying to go for a more broader population?

Speaker 6

And then secondly, with regards to the modified eligibility criteria, how do you think that that is going to to help from a safety profile perspective?

Speaker 2

So let me I can start from the with the safety question, Rob. So we have we are responding to the unfortunate case of a grade 5 toxicity in a patient earlier in the dose escalation. And we think we learned some things about that patient that we can use to improve overall safety for the rest of the study, which is what you're asking. So for example, we're no longer allowing bulky disease, which that patient had. We're lowering the upper age limit.

Speaker 2

That patient was 80 years old. And we're taking a number of measures to try to detect and have treated any kind of occult infection, which as I'm sure you know well, infection is the number one cause of non tumor death in patients who have undergone CD19 CAR T therapy because they've had their B cells obliterated by the therapy. So with these, these are the 3 measures that we do feel

Speaker 1

will add

Speaker 2

to the many safety measures that were already built into the study. So, and your first question, I'm going to have was suitable for Selim except I've forgotten what it was. So if you could repeat it please.

Speaker 6

Yes. So I know in the first in the Phase 1 portion you're allowing for CD19 failed CAR T patients, but that's only for the Phase 1. Are you also thinking about considering looking at that population specifically given the unmet need there?

Speaker 4

Yes. So actually, we as you know, we are still in the Phase 1, but we are learning as we go. I think at the Phase 2, we're probably going to expand the patient population based on what we see in the Phase I. And yes, to answer your question, I think if we see signals from those patients in Phase I, we're probably going to expand that population.

Speaker 2

Yes. And the protocol allows CD19 failures in Phase 2, while FDA required us to have either CD19 people who had failed CD19 CAR T or patients who were ineligible or had refused it in Phase 1. So we're removing that restriction for Phase

Operator

II. And our next question comes from the line of Ken Dolliver with Brookline Capital Markets. Please proceed with your question.

Speaker 3

Thanks. And just to continue with the 808 discussion around the enrollment criteria. And admittedly, this is early on, but based on the changes you've made and whatever other data you looked at in making those decisions, how are you thinking does that have any noticeable difference on the addressable market that you'd previously estimated?

Speaker 2

Cam, thanks for the question. And no, we don't think that the modified eligibility criteria changes the addressable market. Great. Thank you. Thank you.

Operator

Thank you. And we have reached the end of the question and answer session. And I'll now turn the call back over to CEO, James Brickmayer for closing remarks.

Speaker 2

Thank you, Shamali. Overall, we are very encouraged and pleased with the pace of execution in both our clinical programs, 534 and 808 and the enthusiasm of our investigators for these studies. We're looking forward to potentially significant clinical data updates for both programs in the coming months. Thank you for joining us today, We look forward to updating you throughout the year.

Operator

And this concludes today's conference. And you may disconnect your lines at this time.

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Oncternal Therapeutics Q1 2024
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