Oncternal Therapeutics Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 9, 2023

Key Takeaways

  • In October 2023, the company dosed the first patient in its Phase 1/2 study of ONT-534 for metastatic castration-resistant prostate cancer and secured FDA Fast Track designation, with initial data expected in H1 2024.
  • The first patients have also been dosed in the Phase 1/2 trial of ONC-808, an autologous ROR1-targeting CAR T therapy for aggressive B-cell non-Hodgkin’s lymphoma, with initial clinical readout planned for December 2023 and further updates in 2024.
  • Nocturnal reported a Q3 net loss of $9.9 million ($0.17 per share) on grant revenue of $0.2 million, against total operating expenses of $10.6 million.
  • As of September 30, 2023, the company held $40.3 million in cash and investments with no debt, supporting its stated cash runway into 2025.
  • A prostate cancer scientific advisory board has been formed, featuring leading academic and industry experts to support the registrational strategy for ONT-534.
AI Generated. May Contain Errors.
Earnings Conference Call
Oncternal Therapeutics Q3 2023
00:00 / 00:00

There are 6 speakers on the call.

Operator

Greetings, and welcome to Octurnal Therapeutics Third Quarter 2023 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. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr.

Operator

Richard Vincent, Chief Financial Officer, please go ahead.

Speaker 1

Thank you, Rob. 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. Salim Yafji.

Speaker 1

Today's call includes a business update and discussion of our Q3 ended September 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 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. 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, 2022.

Speaker 1

This call contains time sensitive information That is accurate only as of the date of this live broadcast, November 9, 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. Jim Breitmeier.

Speaker 2

Thank you, Rich, And good afternoon, everyone. At Nocturnal, we are now advancing 2 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 onetwo dose escalation study of ONT-five thirty four, our novel dual action androgen receptor.

Speaker 1

Hello. Yes, you're back.

Speaker 2

Okay. Thank you. I apologize, everybody. I'm calling in internationally. ONX-five thirty four is for patients with metastatic castrate resistant prostate cancer who have progressed after treatment with approved AR pathway inhibitors.

Speaker 2

In October, we also received fast track designation from FDA, further supporting our belief that ON-five thirty four may be an important therapeutic alternative for patients with advanced prostate cancer. We expect our initial clinical data readout in the first half of twenty twenty four. With respect to ONC-eight zero eight, our ROR-one targeting autologous CAR T program, We continue to execute on enrollment of the Phase onetwo study in 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 2024. The manufacturing process is delivering large numbers of high quality CAR expressing T cells and may offer reduced vein to vein times.

Speaker 2

Overall, we are delivering on our plan to advance our 2 clinical programs, 534 and 808, through potential significant value inflection point by the first half of twenty twenty four, all while maintaining our cash runway guidance into 2025. With that, I'd like to now turn the call to Oncterno's CMO, Selim Yajji, to expand on our clinical progress with 534 and 808. Salim?

Speaker 3

Thank you, Jim. As Jim mentioned, we are excited to have dosed our first patients in the study of ONC534-1 101, A Phase onetwo dose escalation study that's enrolling patients with metastatic castration resistant prostate cancer with progressive disease that have relapsed or are refractory to prior androgen receptors pathway inhibitors such as enzalazimide or abutirone. Based on preclinical studies and its noble mechanism of action, we believe that UNC-five thirty can provide an important treatment alternative to these patients by addressing a key tumor escape mechanism That results in resistant to currently available AR pathway inhibitors, including AR mutation, AR amplification and splice variants such as AR V7. Enrollment is advancing according to plan and we continue to expect to report initial data in the first half of twenty twenty four. In September, we announced the establishment of our prostate cancer scientific advisory board, which includes Distinguished academic and industry leaders in the prostate cancer field such as Professor Johann Dubono From the ICR in London, Doctor.

Speaker 3

Matthew Smith from Mass General and Doctor. Evan Yu from The Fred Hutch. We look forward to working with our SAB to develop our future clinical and registrational strategy for ONKY-five thirty four. With respect to ONC-eight zero eight, our autologous ROR-one targeting CAR T, we continue to dose patients In the dose escalation portion of our study, UNC-eight hundred and eight-one hundred and one, a Phase III study for patients with relapsed for refractory progressive B cell lymphoma, including those who have failed previous CD19 CAR T therapy. We have seen encouraging expansion and persistence of scar expressing T cells in the study, which has been demonstrated to be positively correlated with clinical response in previous CD19 CAR T studies.

Speaker 3

With this, I now turn the call to our CFO, Rich Benson. Rich?

Speaker 1

Thank you, Selim. Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was $200,000 for the Q3 ended September 30, 2023. Our total operating expenses for the Q3 were $10,600,000 including $1,700,000 in non cash stock based compensation expense. Research and development expenses totaled $7,500,000 and general and administrative expenses totaled $3,100,000 Interest income for the quarter was $500,000 Net loss for the Q3 was $9,900,000 for a loss of $0.17 per share, basic and diluted.

Speaker 1

As of September 30, 2023, we had 59,000,000 shares of common stock outstanding, dollars 40,300,000 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 in December 2023 with additional data readouts in 2024. For ONT-five thirty four, our late DARE product candidate, we expect 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. Jim?

Speaker 2

Thank you, Rich. We are very pleased with the recent progress in our 2 clinical programs, while reiterating our cash runway guidance into 2025. We are excited to be advancing Development of novel pathways in areas with very high unmet medical need, such as CD19 relapses in aggressive lymphoma and metastatic Thank you for joining us today, and we look forward to updating you during upcoming With that, I will turn things back to Rob for the Q and A portion of this afternoon's call.

Operator

Thank you. At this time, we'll be conducting a question and answer Our first question is from Carl Byrnes with Norland Capital Markets. Please proceed with your question.

Speaker 4

Thanks for the questions and then also congratulations on your progress. I'm wondering if you can provide a little more detail With respect to the velocity of patient recruitment in the 534 dose escalation study, and this is obviously considering the urgent And that medical need of indication?

Operator

And then I

Speaker 3

have a follow-up.

Speaker 2

Go ahead, Salim.

Speaker 3

Yes. So, as you know, we designed the study based on the Voin design, which has allowed us to Move forward with the first two cohorts with only 1 patient each if there is no toxicity or side effect So during those cohorts. So, so far, I mean, I think the enrollments and everything is good as expected.

Speaker 2

And Carl, there are a lot of these patients out there.

Speaker 4

Yes. And that's where I was going. It seems like these trials as you progress and advance, they should be relatively easy to populate enroll.

Speaker 2

We hope so. You never know. But what we're finding is that our for most studies, the investigators enthusiastic and the number of patients who are in their systems with These kinds of unmet needs seem to be ample for a good enrollment pattern.

Speaker 4

Excellent. And then just shifting gears

Speaker 5

a little bit on 808, Do you

Speaker 4

have any thoughts there in terms of the potential efficacy signal with the data readout in December, considering the dose will be relatively close to recommend Phase 2 doses of other CAR T therapies? Thanks.

Speaker 2

Yes, I'll take that one, I think that as you probably know, with aggressive lymphoma, responses to CAR T So if there's any

Speaker 4

I'm sorry, Jim, I think you broke up a bit.

Speaker 2

Yes, I did. I'm sorry. Can you hear me better now?

Speaker 4

Yes. Okay.

Speaker 2

I just switched phones. So Given that other CAR T programs have shown that complete responses can develop quickly, We're optimistic that we may have some efficacy to talk about in December.

Speaker 4

Great. Again, congratulations for the progress.

Operator

Our next question comes from Hartaj Singh with Oppenheimer and Company. Please proceed with your question.

Speaker 5

Great. Thank you. And thanks for the couple of questions and really nice update. Things are moving along pretty quickly, Jim and Salim I guess on 808, just one question there is following up on the previous questions. What would you like to see, whether it's dose level 1, 2 or 3, a minimum amount of efficacy in order to move forward.

Speaker 5

And then when you do move forward, you're thinking about dose expansion. What are we thinking in terms of what would be an acceptable durability That you'd like to see as you follow these patients onwards. And then on the other program with 534, 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're getting close to a sort of moving to dose Jim, do you

Speaker 3

want me to take the call? Okay. So Hitesh, I can start Actually, while Jim probably establishing the connection, as you know, we really Dealing with very sick patients, especially patients who are after relapsed from prior CD19 CAR T. Unfortunately, I mean, these patients, the progression free survival and overall survival is very short, which is usually in months, not even in years. And what we would expect, we would expect to see some objective response And also durability of response.

Speaker 3

And that's a big question. What will be good as a durable response In those patient populations that already failed prior CAR T, I think it's a Very objective question and we need to still see some of that data and evaluate it because usually Medium progression free survival there is no more than 3 months currently and the survival rate is no more than 6 months. So I think we are really dealing with very aggressive and very sick patients, but we're hoping for the best. So I'll stop here and I'll take any question if there's any additional ones from you, VirTraj.

Speaker 5

No, Smedes, that's really good. And then just on 534, How do we I guess, what do you expect to see? I mean, you've got all the way can go to 600 milligram oral daily, right? It seems like. And but when do you think you could get to before you would expect DLP, did you need to go all the way

Speaker 3

to 600? Do you think it could be before that? And thanks for the question. So, I think it is also it all depends on the dose escalation and how fast we can go there. But we will actually believe that therapeutic dose or the efficacy dose maybe start from the 300 above And which is that would be the 4th cohort.

Speaker 3

We may start seeing things earlier than that and we're hoping to do that. But I think time will actually will be on our side to see if we'll be able to see any early responses in earlier cohorts.

Speaker 2

And let me add something.

Speaker 3

Yes. Jim, go ahead.

Speaker 2

Yes. So there was a very interesting panel discussion at the SITC conference last week, where several members of the FDA addressed Project Optimus. And what they made clear and emphasizing what's in the FDA guidance here FDA is looking for developers to establish a balance between efficacy and safety. And they are not they're in oncology, in particular, They're encouraging early development to learn more than just the maximum tolerated dose and to For doses below MTD to look for that perfect balance 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 the same principles will apply to the choice of dose for ONC-five thirty four as well.

Speaker 5

Yes. And Jim, I guess, I was just thinking, I know you've probably mentioned this before. Just remind us again, why do you have 2 dose levels, dose level A and dose level B when you move forward from the dose escalation part of the study?

Speaker 2

It's exactly for that reason, Harnedaj. It's what FDA is looking for in this Project Optimus. And they made clear that whenever possible, they expect to see randomization between the two dose levels, so that by the before you start a registration intent study, FDA will have the opportunity to examine efficacy and safety and the risk benefit ratio For more than one dose.

Speaker 5

Yes. This is all very helpful. Thank you for the questions.

Speaker 2

Thank you.

Operator

Our next question comes from Kempe D'Auber with Brookline Capital Markets. Please proceed with your question.

Speaker 2

Great. Thank you. So the question relates to

Speaker 4

534 And Novartis recently presented the data from PSMA 4, which as you know is the Pretaxine setting and we're expecting data any day now from the SPLASH trial, which is also in Same patient population. And I mean based on what you've seen so far and the commentary regarding how These drugs would be used in that setting. How are you thinking about the opportunity for 534?

Speaker 2

Yes. Good question, Tim. So the challenge From the PSMA IV study is that there is a Slightly worse overall survival in the active treatment group in the intent to treat analysis. And so we know that FDA will be looking at their safety data in a very close manner. And 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 option available that doesn't require referral to a different specialist To treat after resistance to enzalutamide or abiraterone develop.

Speaker 2

So we're remaining confident that we have a Commercially viable and clinically important indication here in the prostate cancer continuum.

Operator

We have reached the end of the question and answer session. I would now like to turn the call back over to Doctor. James Breitmeier for closing comments.

Speaker 2

Thank you, Rob. We appreciate everybody's time and attention and the good questions this afternoon. We are 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.

Operator

This concludes today's conference. You may disconnect your lines at this time and we thank you for your participation.

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