Oncternal Therapeutics Q2 2024 Earnings Call Transcript

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August 8, 2024

There are 6 speakers on the call.

Operator

to the Ochterna Therapeutics Second 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. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Richard Vincent, Chief Financial Officer.

Operator

Thank you. You may begin.

Speaker 1

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

Speaker 1

Today's call includes a business update and discussion of our Q2 ended June 30, 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 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 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, August 8, 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 Ochternel, we are advancing 2 1st in class clinical programs targeting cancers for patients with significant unmet medical needs. ONCT-five thirty four, our novel dual action androgen receptor inhibitor or DARE, continues to advance through the dose escalation portion of the Phase III study and we continue to see strong demand from investigators. As a reminder, preclinical studies showed that ONX-five thirty four inhibited front sight cancer cells through both the ligand binding domain and the N terminal domain of the androgen receptor, and it also induced degradation of the androgen receptor. Thanks to this novel mechanism, we believe ONC-five thirty four may address key prostate cancer escape mechanisms from currently approved AR pathway inhibitors such as enzalutamide and abiraterone, which include multiple LBD mutations as well as splice variants such as AR V7.

Speaker 2

The clinical trial is proceeding well. We have not observed any dose limiting toxicities or other concerning side effects, and we recently announced that the 6th dosing cohort of the study is now fully enrolled. Patients in this cohort are receiving 1200 milligrams of ONX-thirty 4 administered orally once per day. 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 the 3rd dose level of 600 milligrams 534 daily. We plan to share an initial clinical data update for ONK534 later in the Q3.

Speaker 2

Now switching gears to ONT-eight zero eight, our autologous ROAR-one targeting CAR T product. Our Phase III study in patients with relapsed or refractory aggressive B cell lymphoma, including patients who have failed previous CD19 CAR T treatment, is enrolling in treating patients. There have been no dose limiting toxicities observed in the current dosing cohort. We expect to report updated clinical results, including data from patients treated with the new dosing schedule in the Q4 of 2024. With this, I now turn the call back to our CFO, Rich Vincent.

Speaker 1

Rich? Thank you, Jim. Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was $800,000 for the Q2 ended June 30, 2024. Our total operating expenses for the Q2 ended June 30, 2024 were $9,700,000 including $1,400,000 in non cash stock based compensation expense.

Speaker 1

Research and development expenses totaled $6,600,000 and general and administrative expenses totaled $3,100,000 Net loss for the 2nd quarter was $8,600,000 for a net loss of $2.89 per share, basic and diluted. As of June 30, 2024, we had approximately 3,000,000 shares of common stock outstanding, $21,400,000 in cash, cash equivalents and short term investments and no debt. We believe these funds will be sufficient to support our operations into the Q1 of 2025. With respect to upcoming milestones, we are looking forward to the following updates. BRONC five thirty four, our lead DARI product candidate, we expect to present initial clinical data in the Q3 of 2024 with additional data readouts in the Q4 of 2024.

Speaker 1

For ONC-eight zero eight, our ROAR-one autologous CAR T, we expect to report a clinical data update in the Q4 of 2024. With that, I will turn things back over to the operator for the Q and A portion of this afternoon's call. Diego?

Operator

Thank you. And our first question comes from Carl Byrnes with Northland Capital Markets. Please state your question.

Speaker 3

With respect to the clinical data update for 534 in the 3rd quarter or late Q3 to be specific. What do

Speaker 4

you expect

Speaker 3

what should we be expecting there? Safety data, which would be inclusive of the 1200 milligram dose? Would we be also potentially expecting PSA reduction numbers? And if so, what would that be through the first 5 cohorts or all the cohorts? And then I have a follow-up as well.

Speaker 3

Thanks.

Speaker 2

Go ahead, Salim.

Speaker 5

Yes, Carl. So I mean, with regards to what we would expect, we would expect to present a safety data for sure and plus some of the PSA parameters probably will be an early one, so based on the follow-up periods will be not too long.

Speaker 3

Great. And then the additional clinical data in the Q4, what might that consist of? Thanks.

Speaker 5

So in the Q1, the additional clinical data will be probably more of a longer follow-up, more cohorts, I mean, if we have. So I think we'll be more advanced than what we're going to be showing in the Q3.

Speaker 3

Got it. And then finally, with respect to 808, how many patients, if you could disclose, have been enrolled and with the update that you anticipate in the Q4, how many subjects might that be covered? Thanks.

Speaker 2

Yes, Karl, we haven't disclosed the enrollment on the CAR T program yet. But I think as you know and as we show in our corporate deck, we have we revised the dosing regimen with the CAR T, which we found were very active, very active T cells. And we have enrolled patients under the revised and amended dosing scheme and we're not seeing any dose limiting toxicity.

Speaker 3

Great. Thanks. And again, congratulations on the progress.

Speaker 2

Okay. Thank you.

Operator

Our next question comes from Kempe Dovar with Brookline Capital Markets. Please state your question.

Speaker 4

Great. Thank you. With regard to 534 and this question is admittedly speculative, but is there any possibility you would move to higher dosing So, Cam, it's a great question. And so,

Speaker 2

So, Ken, it's a great question. And so we are collecting a lot of data on these patients. And so we have pharmacokinetic data. We've got some interesting and novel biomarker work that we're doing and then of course the efficacy and the safety. And so decisions about dose levels for any additional cohorts will be made with the Scientific Review Committee based on the totality of available data.

Speaker 4

Okay. That's helpful. And then, again, on the same theme, are there any practical limits with regard to administration if you go to higher doses?

Speaker 2

So we have a we're using a 200 milligram tablet. And so it is perfectly feasible to give more than 6 tablets a day for if the data suggest that we should go higher.

Speaker 4

Great. That's all I have for the moment.

Operator

Thank you.

Speaker 2

Thank you, Ken.

Operator

And there are no further questions at this time. I'll hand the floor back to Doctor. James Breitmeier for closing remarks.

Speaker 2

Thank you, Diego. So as you can tell, we remain encouraged with the Phase 1 results from our clinical programs and are looking forward to clinical data updates with you in the coming months. So I'd like to thank you for joining us today, and we look forward to updating you throughout this year. Thank you, and good afternoon.

Operator

This concludes today's conference. All parties may disconnect. Have a great evening.

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Oncternal Therapeutics Q2 2024
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