Q2 2023 Oncternal Therapeutics Inc Earnings Call

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Greetings and welcome to the second quarter 2020 financial results call. At this time, all participants are in a listen only mode.

Question and answer session will follow the formal presentation.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

This conference is being recorded and it is now my pleasure to introduce to you Richard Vincent CFO . Thank you Richard you may begin.

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 , Dr. James Reitmeier, and our CMO, Dr saline yards cheek.

Today's call includes a business update and discussion of our second quarter ended June 32023 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 long 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.

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.

Putting 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 August 10th 2023, we.

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.

Jim.

Thank you rich and good afternoon, everyone and I internally, we are now advancing two clinical stage programs targeting cancers for patients with significant unmet medical needs.

Last week on internal announced that we received a study may proceed letter from the U S. FDA for the phase <unk> dose escalation study of arc 534 for patients with advanced prostate cancer.

Fda's review of the IMD 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 a study in the third quarter and expect our initial clinical data readout in the first half of 2024.

We are very excited to bring bringing on $5 34 to patients suffering from advanced prostate cancer soon.

As a reminder, our preclinical study results suggest that <unk> 34 is active against the most common androgen receptor aberrations that drive tumor resistance to currently approved AAR signaling inhibitors.

Such as <unk> or.

Our CMO.

<unk> will provide more details about the study design and ramp up plans in a moment.

With respect to our <unk> targeting autologous car T.

Either way we are very pleased to report that the first patients have now been dosed and then enrollment is meeting or surpassing our expectations. We believe on pay to wait maybe a best in class <unk> car targeting car T. As it builds on our extensive clinical experience with <unk>, which was found to be safe and Sam.

Phase one and two studies pre.

Preclinical models show robust and specific cytotoxic activity Ivanka Ada weight against war, one expressing cells from multiple tumor types clinic.

Clinical manufacturing runs completed to date continue to support our thesis that our manufacturing process is robust reproducible and scalable and shorter and several approved car T therapies we.

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 turnover CMO Selim yards, Jason to expand on our clinical plans for <unk> 30 core and our progress with eight away Celine.

Thank you Jim good afternoon, everyone.

As Jim mentioned now we know is that <unk> 534 is active we are working diligently to bring on slide 34 to two patients as fast as possible.

Let me unpack 34, one to one.

As one two dose escalation study will enroll patients with authentic castration resistant prostate cancer was progressive disease <unk>.

Relapsed or refractory to next generation androgen receptor signaling inhibitors, including <unk> or <unk>.

The dose escalation will use the base on optimal interval or beyond design, which is an effective statistical method to optimally and quickly identify the maximum tolerated dose or MTG.

Once the MTBE is identified.

We're all into a phase two Simon two stage design to evaluate the safety and efficacy of 534 at two dose levels.

The ramp up to the <unk>.

<unk> is well underway and we have already selected clinical sites.

Support initial dose finding portion of the study.

The potential of <unk> 34 to address a significant unmet need for patients with relapsed refractory metastatic prostate cancer.

Has been appreciated by top Kols and academic institution in the U S and Europe .

We are excited to be working with them to advance the clinical investigation of <unk>.

Our novel product candidates.

Based on this progress.

Now expect to initiate the study in the third quarter of 2023 and expect to report initial data in the first half of 2024.

Now switching gears to our broad one targeting car T.

We recently treated our first patients in the study.

<unk>.

101 phase one two study for <unk> for.

For patients with relapsed or refractory aggressive b cell lymphoma.

Including those who have failed previously CD 19 car T therapy.

As a reminder, patients who have failed TV 19 treatment.

Extreme unmet medical need with the little likelihood of responding to their next treatment and very short medium progression free survival and overall survival.

Overall, we're 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 mentioned rich.

Thank you Celine.

Yeah.

Our revenue is currently derived from research and development grants received from the NIH Grant revenue was <unk> 1 million for the second quarter ended June 32023.

Our total operating expenses for the second quarter were $9 7 million, including $1 7 million in noncash stock based compensation expense.

That represents a $2 $5 million decrease from our total cash operating expenses of approximately $10 5 million for the first quarter of 2023.

That represents an efficient wind down.

The activities, resulting from a re prioritization of initiatives that we announced on April three 2023.

Research and development expenses totaled $6 6 million and general and administrative expenses totaled $3 1 million.

Interest income for the quarter was <unk> 6 million.

Net loss for the second quarter was $9 million for a loss of <unk> 15 per share basic and diluted.

As of June 32023, we had approximately $58 7 million shares of common stock outstanding $45 5 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 we remain on track for <unk>. Our war one I'll talk as car T. We expect to report initial clinical data by the end of 2023 with additional data Readouts in 2024.

From $5 34 are late Dart product candidates, we now expect to initiate our phase one two study in the third quarter 2023 ahead.

Ahead of schedule 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.

Very pleased with the recent progress as we continue to execute on our plan to achieve significant clinical catalyst for our two lead programs, while retaining our cash runway into 2025.

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

Thank you, Sir we will now be conducting a question and answer session.

To ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate that your line is in the queue. You May press star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing to sarkies.

One moment, please while we poll for questions.

And the first question comes from the line of Carl Byrnes with Northland Capital markets. Please proceed with your question.

Thanks for the question and congratulations on progress with respect to $5 34 do you see.

Potential for early PSA reductions signal.

And the phase one portion of this study.

Obviously, considering the Tvs will determine that.

Sure.

You will be determined using the incidence of DLP with I think a timeframe of 28 or so days.

And then I have a follow on question.

So Karl Yes, we do think that PSA signal as possible and we are.

The eligibility criteria were designed to.

Enrich for patients, whose disease remains androgen dependant androgen receptor dependent.

And the mechanism of action wouldn't would include inhibiting PSA as as an early biomarker.

Excellent excellent and similarly, with eight Oh wait and considering the dosing there and the study is close to if not.

Consistent with recommended phase II dosing or other car T. Therapeutics do you see a potential for early efficacy signal in that initial data.

Selim you want to take that one.

Yes, sure, Yes, I mean, I think we would expect.

You have an early signal as well.

As you know as those patients are very hard to treat and after failing, especially after failing CPA 19.

CD 19 cost cheap, but we would expect actually to have an early signal and also we would like to see.

Duration of.

Response.

We'll be actually something.

Since we already kind of like looking forward too.

Yes.

Great. Thanks, Congratulations again.

Thank you.

And the next question comes from the line of hard Taj Singh with Oppenheimer <unk> Company. Please proceed with your question.

Great. Thank you. Thanks for all the updates and I got a couple of questions. One is just on Italy. Following on the previous question.

If I recall controls Hawkeye you've got.

B cell NHL patients Mcl, and then various types of <unk> patients in there on your expansion, you're already indicating mcl and <unk>.

I guess.

<unk>.

We'll go to Matt I believe showed pretty good really good signal of Mcl. So just building on the previous question I mean, youre close to recommended phase two dose starting off can you just kind of walk us through what your dose escalation look like and then I imagine would those be mcl patients would you see here I just got a follow up question.

Okay.

Yes.

Helane.

Yeah. So.

I think what we try and get you do I mean.

In the beginning when the dose escalation, we are actually accepting all aggressive lymphoma in the dose escalation, however, and the expansion I think we would like to have separate you'd like mcl from <unk>.

Aggressive lymphoma type as of now we only going was two indication which is the mcl <unk>.

So.

What was the other question.

Yes, just a follow up to that fleet, which is that.

Got it.

This is a car T and youre going in.

With your knowledge of the Alberta, Mab at a higher dose.

In terms of just.

<unk> should we just expect.

Something analogous to what we've seen with car T. As previously Crs and other kinds of.

Toxicity.

Well if I can.

Yes sure.

I can take that so and so so so hard times as I'm sure you know.

The.

And most 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 car T cells and how robustly they expand in the patient.

And our target target the tumor.

Have the type of car T.

Construct and process that we're doing.

As 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.

Car T is doing what you wanted to.

Yep Yep.

Okay that makes sense Jim.

It really makes sense.

That makes a lot of sense.

And then yeah.

At the end of the year the data would be just a safety update or we'd see some clinical potential efficacy data also potentially.

Helane, yes, so we would expect to see preliminary data, even including some efficacy.

Data by the end of the year, yes.

Great. Thank you thanks for all the questions.

Thank you.

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

Hi, there this is resume entre Lee thanks, so much for taking our question just a general one first about $5 34 can you talk a bit about the changing landscape in prostate cancer treatment and how you think $5 34 could eventually fit in.

Happy to Rosemary and thank you for standing in today.

No.

We believe that.

There is that the part of the landscape, where we're sitting is one that has very significant unmet medical need.

The the androgen receptor signaling inhibitors and dilutive by <unk> <unk>.

And abiraterone.

Sure.

Core therapy.

And standard of care for.

Virtually every patient.

In the in the early portion of treating metastatic disease.

And at the time that patients become resistant to those to those agents.

Some of them have some of them become androgen receptor independent.

And thats, not who we're targeting but a very large proportion of them.

Remain androgen receptor dependent but resistant to standard are signaling inhibitors and so that's a large population and it's in that.

In that space between Andrew hormone therapies, and chemotherapy or radiotherapy, which which have much more toxicity. So so we think it fits perfectly there to begin with however, we're also showing 534 also has very robust activity.

With patients, who had a native or mutated androgen receptor 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 level.

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.

Got it great. Thank you that was really helpful. And then maybe just one quick one on 808. So do you have an explanation for maybe how many patients you could be on.

By your your data up there I know, it's going to be really soon after our presentation.

Yes Celine.

Yes, so you're talking about.

Presented by the end of the year is that what you saw how many many patients yes, so probably would be at least three patients was it was a different time to follow up.

Great. Thank you so much.

Sure.

Thank you Rosemarie.

And the next question comes from the line of Ken Oliver with Brookline Capital markets. Please proceed with your question.

Hi, Thank you just.

Just quickly to.

To be sure I understand the.

Lance.

Inscape with $5 34.

Jim are you, saying that.

You're thinking this would come in between after first line therapy, but before chemotherapy.

Exactly camp.

Okay.

Now as you know.

As you know there are some people are using <unk> plus docetaxel as the first treatment for metastatic disease.

This agent would still be suitable after that regimen as well.

Yeah.

Got it and.

What percentage.

The pop the patient population do you think would fall in the base.

This targets targets that you've set out.

Well, that's something that we're going to learn in the clinical trial.

And we do think that after failing.

Zulueta minor aborad around.

That somewhere between one third and two thirds of the patients remain androgen receptor dependent.

Got it thank you.

There are no further questions at this time I would like to turn the floor back over to Dr. Brian <unk> for any closing comments.

Thank you John and thank you, everybody, who listened and for the excellent questions and discussions.

We now have two 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 two 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 comp for instance.

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

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