Q3 2021 Oncternal Therapeutics Inc Earnings Call

Greetings welcome to the alternate therapeutic Stinks Q3, 2021 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.

Please note this conference is being recorded.

I will now turn the conference over to your host Rich Vincent CFO. Thank you you may be in.

Thank you Alex.

Good afternoon, everyone and thank you for joining us today.

Joining me on the call. This afternoon, our our president and CEO Doctor, James Brett Meyer and our CMO Doctor Swilley Yazeed.

We welcome all of you today.

Today's call includes a business update and discussion of our third 2021 third quarter financial results and upcoming milestones, which will be followed by Q&A.

Today's press release and a replay it saves earnings call will be available on the Investor Relations section of on <unk> website for at least the next 30 days.

We also filed or 10-Q for the third quarter of 2021 earlier today.

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 and future financial and operating performance.

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 our qualified by the cautionary statements contained in today's press release and R. S. E C filings, including our Form 10-Q put Carter ended September 30th 2021.

This conference call contains time sensitive information that is accurate only as of the date of the slide broadcast November 4th 2021.

We undertake no obligation to revise or update any forward looking statements to reflect events or circumstances occurring after the date of this conference call.

Expect to agree on a pivotal study design for patients with mantle cell lymphoma mcl in the coming months.

<unk> remains an increasingly visible target in the oncology space since it was the subject of M&A activity, including the acquisition of <unk> bio by Merck and company and B E Therapeutics by Beringer.

101, which is now known as MK 214 O.

Isabella <unk> bio's, <unk> targeting antibody drug conjugate or ADC.

And was originally invented and developed at <unk> terminal.

This ADC utilizes zillow virtu mab as the <unk> targeting moiety.

We also continue to collaborate on two of the investigator sponsored clinical studies, a zillow Virtu Mab at UC San Diego.

First a phase <unk> clinical trial of Zillow Berta Mab in combination with Paclitaxel for the treatment of women with her two negative metastatic or locally advanced unresectable breast cancer has completed enrollment.

Second.

Our phase II clinical trial of <unk> in combination with the need of class a bcl two inhibitor in patients with relapsed refractory CLO is ongoing and enrolling patients.

With respect to our <unk> targeting cell therapy programs, we continue to advance them towards the clinic as planned.

For our lead autologous car T program.

Which we have selected for which he was selected.

Eight O eight as the lead.

We have made tremendous progress in GMP process development with our CMO collaborators and are completing IND supporting preclinical studies with leading academic institutions to enable the submission of the first AMD in the first half of 2022.

We also made progress regarding potential second generation allogeneic cell therapy programs.

We established a partnership with cellular already to evaluate placental cell derived therapies targeting <unk> one.

And we strengthened our partnership with the Karolinska Institute in Sweden.

Including recently, joining Nextgen NK institutes competent center for the development of next generation NK based cancer Immunotherapies.

We also recently announced that we have engaged a group of industry renowned experts in the cell therapy field to serve as our cell therapy Scientific Advisory Board.

And to support our efforts to bring safer and effective <unk> targeting cell therapies to patients faster.

We asked our internal and our newly formed <unk>.

<unk> are very excited about the potential of our cell therapy programs targeting <unk>.

Which may allow for the selective targeting of tumor cells that express ror, one while relatively sparing healthy tissues.

And another program, we also advanced the development of <unk>.

216, which was formally designated Teekay to 16, our investigational targeted small molecule inhibitor of the <unk> 26 transformation specific or Etfs family of uncle proteins.

He was active in preclinical prostate cancer models that are resistant to current standard of care therapies, such as <unk> and amber red around.

We believe at 534 may have the potential to address the significant unmet need for men with prostate cancer caused by tumor resistance mechanisms, including those involving expression of androgen respect scepter splice variants such as a R V seven.

With that I will now turn the call over to rich Vincent to review, our financial results and upcoming milestones.

Thank you Jim.

In October 2017, Sir I'm awarded in 19.3 million dollar grants to researchers after U C. San Diego School of Medicine to advance our phase one b two clinical trial evaluating so berta map in combination with a broken hip for the treatment of patients with B cell lymphoid.

<unk> sees including M. C. L M C L O.

We are conducting a study in collaboration with U C. San Diego and expect to receive approximately 14 million and development milestones under research subtle wards Route the award period.

In conjunction with this award or Grant revenue was 2.4 million 1 million for the third quarter ended September 30th 2021.

Our total operating expenses for the quarter ended September 30th 2021, $11.8 million, including $1.5 million in non-cash stock based compensation.

Research and development expenses for the quarter totaled 9 million in general and administrative expenses totaled $2.8 million.

Net loss for the third quarter was 9.6 million for loss of 19 cents per share basic and polluted.

As of September 30th we had $97.4 million in cash and cash equivalents.

You believe these funds will be sufficient to support or operations into 2023.

As of September 30, we had 49.4 million shares of common stock outstanding.

With respect upcoming milestones.

Year to date.

Eight O eight as well as for our dual action a R inhibitor prostate cancer candidate arc 534.

Look forward to updating you in the coming banking conferences and at our R&D day on January 25th.

Thank you for joining us today with that I'll think I'll turn things back to Alex for the Q&A portion of this afternoon's call.

Thank you.

At this time, we'll be conducting a question and answer session.

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

Great well, thank you Jim and team for the update just a couple of questions.

Jim I know you're going to smile. This one because you always get it so I have to ask it with you.

We'll go to Matt.

You've been having I guess FDA interactions.

And you have been indicating that you had given an update to investors.

The next few months how has your thinking changed.

These interactions as to what the parameters of the contours of our clinical development plan could look like in Mcl. So that's number one any updates there and then number two your you would warn car T cell therapy. The Ind's plan for the first half 2022.

What kind of clinical development plan do you foresee once that R&D comes true.

You know is it going to be sort of a dose escalation dose expansion, what kind of tumors basket study et cetera, So love to get some color there. Thanks for the question.

Sure Hi, Josh.

So I think that the.

The interactions with FDA have been open.

Collegial and very helpful and and so what I, what I would say.

Has evolved with the.

The latest information that we provided them with the clinical results from the <unk> meeting.

And and I'm sure you'll recall that.

You know some particular clarity and the escrow dataset emerged that Zealand Berta Mab plus ibrutinib is providing a very encouraging.

Progression free survival compared to Bruton nib alone and so that entered into our discussions with them and.

Plays into a study designed for registration studies that we're that we're discussing with them I think I think we've discussed on previous calls that we are considering.

Considering that it's likely to be a randomized study of PTK inhibitor alone versus PTK inhibitor, plus Isla Verde map and so with a with with encouragingly stronger results for complete response and overall.

Our response.

And and progression free survival that gives us some very interesting material.

For negotiating trial designs.

So that's your first question, let me turn it over to Selene, our Chief Medical officer to discuss the potential shape of a car T clinical development program.

Yes, Thank you Jim.

So actually yes, we are very excited about the car.

Car T program and what are we planning to do is a.

Phase one dose escalation to get.

Recommended phase two dose.

A breast cancer study is an investigator sponsored study and the timing of the data release achieved.

His hand.

However, we saw was that said.

Jim as mentioned earlier.

The study has been fully enrolled and hopefully.

It will be.

Published soon.

Yeah.

Great. Thank you everyone.

Thank you.

Thank you.

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

Great. Thank you. Thanks for the question congratulations by the way on your progress just briefly do you have any thoughts in terms of the timing of IND, enabling studies for <unk> three four and then also to the extent you can speak on the research collaboration with cellular already.

And also the Karolinska Institute, what you recently announced in terms of when you might see identify candidates there. Thanks.

Karl Thanks, Thank you and I think I can I think I can handle both of those questions.

So so for 534.

We have we we have selected the molecule.

And.

With <unk> and you're familiar with the drill on getting to an I N D that in the early going manufacturing is usually rate limiting to get two material representative material that you can use for your IND, enabling studies and so.

We're not ready to guide on when the IMD might be ready to submit.

I was wondering if you could give some color to the persistence of.

On the eighth week of car T cells in the body.

And I'm, just trying to get an idea of how long lasting the therapy will be.

And also what percentage of antigen escape you estimate prolong technique.

That could be important for our cancer relapse scenario.

Thank you. Thank you those those are both good questions and so.

So.

So as far as persistence goes.

We are you probably.

Aware of some work that was done.

By investigators at the University of.

Washington, and Seattle at the Hutch with a roar, one car T that had rather short persistence.

And we think we understand why that was it is it is we think it's because they used a rabbit antibody fragment.

To target, where our one and as a result of that the car T.

Did they administered had foreign antigen rabbit rabbit protein on the surface and we think contributed to low persistence.

Very malignant them, there they have lower tumor forming potential.

And lower.

Aggression pattern. So so we're we're hopeful that rod one negative escape will be less common than it has been with particularly CD 19.

Yeah.

Thank you. Thank you that does radio spot.

You mentioned that the initial plan is with desk on takeaway B cell malignancies. I was just wondering if there are any if you were thinking in terms of testing that in solid cancers as well.

Selim do you want to talk about that yeah.

Yeah, absolutely. So I think our first generation will be and.

T cell malignancy and as we redevelop our.

Oh and one.

Cell therapy I think.

Solid tumor will be would be targeted as well.

Sounds great. Thank you for taking my questions.

Sure. Thank you for the questions.

Thank you ladies and gentlemen, we have reached the end of the question and answer session. I will now turn the call over to Dr. Jim Bright Meier for closing remarks.

Alright. Thank you everybody. We appreciate your interest and attention for our third quarter release, and an overview. We look forward to seeing you. We hope at our January 25th R&D day, which will provide.

A review of our pipeline and priorities and offer insights from key opinion leaders.

<unk> mcl.

And car T and androgen receptor biology with that thank you and goodbye.

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

Do you for your participation and have a wonderful day.