Q1 2022 Oncternal Therapeutics Inc Earnings Call
[music].
Greetings and welcome to all internal Therapeutics, Inc. Third quarter 2022 financial results call.
At this time all participants are in a listen only mode.
A 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.
As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Richard Vincent Chief Financial Officer. Thank you you may begin.
Thank you Doug.
Good afternoon, everyone and thank you for joining us today as we cover our first quarter 2022 earnings.
Joining me on the call. This afternoon are our president and CEO , Dr. James <unk>, and our CMO Doctor slain Your street.
Today's call includes a business update and discussion of our 2022 first quarter financial results, which will be followed by Q&A.
Today's press release and a replay of today's call will be available on the Investor Relations section of long term notes website for at least the next 30 days, we filed our 10-Q for the first quarter of 2022 earlier today as well.
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 initiation of our preclinical and clinical studies the potential for our <unk> 301 study to support a BLA submission.
The timing of planned interim data updates and the timing of our regulatory filings and submissions.
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-K for the full year ended December 31 2021.
This call contains time sensitive information that is accurate only as of the date of this live broadcast may five 2022.
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 Brian Meyer.
Thank you rich and good afternoon, everyone and internal we are advancing our focused and robust product pipeline with clinical and preclinical product candidates that target cancers for patients with unmet medical need.
During the first quarter of 2022, we further sharpened our focus on the achievement of key pipeline catalyst in hematologic malignancies in prostate cancer as we navigated unprecedented challenging macro environment, which is obviously continuing in the second quarter, including today's stock market.
You bet.
We made significant progress towards the initiation of our global Phase III Registrational study Zillow 301 for GE liver to Matt in patients with mantle cell lymphoma.
Which is planned to be initiated in the third quarter of 2022.
<unk> is our investigational potentially first in class humanized monoclonal antibody that inhibits receptor tyrosine kinase like orphan receptor, one or one function by binding with high affinity to a biologically important epitope on the receptor.
We continue to evaluate additional countries and study sites for the phase III study to ensure robust enrollment as we mitigate disruptions caused by the situation in Ukraine.
As a reminder, we reach consensus with the FDA on the design and major details of Zillow 301 study plan, which is supported by encouraging data from our ongoing phase one two clinical trial of <unk> in combination with Ibrutinib the serial study.
We look forward to providing a data update on that study at this year's American Society of clinical oncology meeting in Chicago in June 2022.
Our autologous car T cell probe card program targeting <unk> one.
<unk> also continued.
To advance and is on track for an IND filing in mid 2022.
In our initial phase one study, we plan to enroll patients with relapsed or refractory hematologic malignancies.
<unk> knows who have failed CD 19 car T cell therapy.
We established our clinical manufacturing agreement with the Dana Farber Cancer Institute to conduct collaborative cgmp process development and manufacturing activities for use in our upcoming first in human studies.
Our partners at the Dana Farber has some of the best cell manufacturing facilities in the world and proved to be a perfect fit with the cell processing technology, we selected for our <unk> car T program.
Research collaborations with cellular already and with the Karolinska Institute continue to generate encouraging data for our other next generation off the shelf <unk> based cell therapy program.
Next on five three for the lead candidate of our dual action androgen receptor inhibitor or <unk> program.
Continues to advance towards IND, enabling studies.
Five three for may be a highly differentiated and novel treatment alternative for patients with advanced prostate cancer.
As we believe it interacts with both the end terminal and the ligand binding domains of the androgen receptor inhibiting its function and inducing its degradation.
Preclinical data have shown that arc 534, exert anti tumor activity in clinically relevant prostate cancer models, including those with <unk> amplification.
<unk> resistance or tumors expressing androgen receptor splice variant.
<unk> seven all of which represent significant unmet medical needs for patients with prostate cancer.
Finally, we announced the de prioritization of development of our E twenty-six transformation specific or.
Inhibitor <unk>.
Along with the discontinuation of enrollment in the phase one two study evaluating <unk> in patients with relapsed or refractory Ewing sarcoma.
This resource reallocation will allow us to further focus on hematologic malignancies and prostate cancer.
While deploying our capital toward meaningful catalysts, especially those related to our lead asset <unk> over to Matt.
Let me now turn the call back to him.
Colonel CFO Richardson.
Thank you Jim.
Our grant revenue is derived from a California Institute for regenerative medicine, or CERN Grant Sub award and to research and development grants from the National Institutes of health or NIH in October 2017, some awarded an $18 $3 million grant to researchers at the U C.
Diego School of Medicine to advance our Sorel study.
We are conducting this study in collaboration with UC, San Diego and expect to receive approximately $14 $4 million in development milestones under research Sub awards throughout the award period that was substantially completed from a revenue perspective in the first quarter of 2022.
In the third quarter of 2021, the NIH awarded the accompanying to research and development grants for up to $2 2 million to support preclinical activities for the companies at $5 34, and Oct to 16 programs.
Including $7 million that is payable to sub awardees.
Our grant revenue was <unk> 7 million for the first quarter ended March 31, 2022 or.
Our total operating expenses for the first quarter ending March 31, 2022 were $10 $7 million, including $2 million in noncash stock based compensation expense.
Research and development expenses totaled $7 million and general and administrative expenses totaled $3 7 million.
Net loss for the first quarter was $9 9 million for a loss of <unk> 20 per share basic and diluted.
As of March 31, 2022, we had $82 2 million in cash and cash equivalents and no debt.
We believe these funds will be sufficient to support our operations well into the third quarter of 2023.
We have and will continue to manage expenses deliberately and we'll explore all potential sources of capital to enable us to reach our milestones.
Yeah.
As of March 31, 2022, we had 49 4 million shares of common stock outstanding.
With respect to upcoming milestones.
For our Zillow Berta Mab program, we expect to initiate the global Registrational Phase III study Zillow 301 in the third quarter of 2022.
We expect.
To report interim clinical data update for patients with Mcl mcl treated with <unk> plus ibrutinib from our ongoing <unk> study at the June 22, Astro meeting.
We also expect to have a phase <unk> investigator sponsored trial of Zillow, <unk>, plus docetaxel enrolling patients with metastatic castration resistant prostate cancer in mid 2022.
On the cell therapy front, we are on track to submit our first IMD pronged eight O eight our autologous <unk> car T cell candidate in mid 2022.
For <unk> 534, our lead product candidate <unk>.
We're on track to initiate IND, enabling <unk> toxicology studies and GMP manufacturing in the second quarter of 2022.
Now I will turn the call back over to Jim.
Thank you rich we look forward to multiple catalysts in 2022, especially the initiation of our global Phase III <unk> study.
And submitting our <unk> car T IND application.
Advancing our diary program towards the clinic.
Our sharp focus on resource allocation prudent cash management and the strong balance sheet are enabling us to navigate this historically challenging macro environment.
We plan to continue to focus focus our resources on areas of the highest unmet patient need where we believe our product candidates can make the greatest difference for patients.
For joining us today, and we look forward to updating you during upcoming medical and banking conferences.
Hi, I'm <unk>. So just what are you thinking about that and I just got a couple of quick follow up questions after that.
Sure I'll I'll I'll start and <unk> can comment as well the the the three O two.
The three have to study you're referring to is is one of the really novel aspects of our registration study design because during the four month running.
Our enrichment portion of the study where patients receive single agent Ibrutinib a percentage of those patients will progress on on a brunette and so they're already in our study they're already well documented with disease parameters medical history, and everything and so too.
To to give them the opportunity to see if their disease can be re sensitized to a brutal nab with zeal averted ma'am therapy.
It's a very convenient and incrementally inexpensive way to to test for for impact of of really very matter in this resistant disease. So so we were we are still planning to conduct that part of the study as well.
And since it's open label that would also give us an opportunity to talk about the results in real time or medical conferences without having to wait for the blind to be broken and the main three O. One study.
So when do you want to add anything to that.
Well.
That's great.
Great Great and then the other question I have is just you know on on eight O eight.
The <unk> the the cartoon therapy Uhm.
Jimmy thing if you can just kind of describe you know once you file the I N D. In mid 2022, what's the <unk> clinical program you know set up so that we can look forward to any baskets been surfing to retype.
Apologies versus solid tumors, just what are your thoughts on that could look like in the second half of this year.
Go ahead sleep Yep, So uhm hope that this would be mainly and how 'bout the logical malignancies as a first and human study, specifically, we gonna do and dose escalation and lymphoma B cell lymphoma patients once we reach our recommended to.
Phase two portion then we can expand to other cohorts as well.
Yeah.
Got it so I can just so I'm clear it'll be <unk>, meaning.
We'll have a basket of patients with different types of tumor types and then pick the ones you wanted those expanding to offer me get into your recommended <unk>.
That's so and the dose escalation, we would have a beach only b cell lymphoma, including the fuselage be solid form M. C. L. A.
Maybe.
Oh, sorry aggressively inform us that's when the dose escalation now and the expansion cohort, we will expand endorse patient population for sure but also we may open.
Indication and how much a logical malignancies like maybe example, multiple myeloma ordered for the.
Yeah.
Is there any sort of possibly that you see with the car T program, whereby there's some tumor type you're looking at for the unmet need is high and upset you know if you see a good signal and dose escalation and you're getting a dose expansion that that could actually form the basis for potential and accelerated approval type scenario I know that's no problem.
Ability, but just any thoughts there.
Yeah, absolutely I mean, I think we <unk> as you know since this is gonna be again dose escalation open label, we're going to be looking into signal as we go and.
We see that something could be a possibility to get a quick maybe quick approval or less colorist approval. We will we will go after that's for sure.
Yeah, and these will be patients that are later line general in general therapy than than what the raw one antibody would have seemed like <unk>.
Yeah, absolutely and as you mentioned this is will be in relapse refractory hematologic malignancy, which is probably a little bit later Ah line of setup, including patients who have failed see the 19th of cheap we're just be a huge medical moved out as well.
And then last question is just where when you see filing the the I D. Four at 534.
So we haven't we haven't guided to the the the the.
Timing of that <unk> Heartaches and the reason is that like other people there we're experiencing some supply chain uncertainty, including things such as slots for manufacturing activities and availability of animals.
And equipment for toxicology studies. So this is this is an area where there's still some continuing impact from COVID-19. So.
So D.
The the.
You know so we just haven't been specific yeah, and when we have greater clarity around timing of the IMD, enabling work then we will make it we.
We will.
Say that out.
Great Great no that makes sense. Thank you all for the update and really appreciate it.
Thank you. Our next question. Our next question comes from the line of Karl Burns from Northland Capital. Please proceed with your question.
Thanks for the question and congratulations on your progress with respect to 031 and the three O. Two studies, how many sites do you anticipate recruiting or participating in those studies I think before you were looking at around 50 and I guess my question is has that changed given what's going on in eastern Europe . Thanks.
Go ahead <unk>.
Yeah, I think we monitoring the situation very closely and you know it's a short answer yes, we trying to to look up into additional sides and especially.
So in Europe , now, it's kind of a little bit.
Difficult to <unk>. So so yeah, we we may go a little bit beyond that yeah.
Great. Thanks, that's helpful.
Thank you Carl.
Our next question coming from the line of <unk> Coleman with a P. T. I G. Please proceed with your question.
Hi, Yeah. Thanks. Good afternoon. This is Brian for coronary and thanks for the update and thanks for taking our questions. Just one for me regarding the use of delivered imagine C. R. P. C is the 158 signaling pathway, providing the main biology rationale for that <unk> and is it really raw.
One driven our understanding is that <unk> is also a receptor for went five day. Thank you.
Hi, Brian Thanks, Thank you for standing in for good very today.
So so the.
<unk> and Roar too can actually form a head or a dimer, which which can act as a.
As a receptor for went Friday and so the.
<unk> is for us kind of in the background, we're not targeting at because first of all our antibody doesn't target roar too and it's also harder to target roar to selectively on tumors because it has a broader distribution on normal tissues. So D.
Rare one is highly expressed on prostate cancer, that's part of the rationale. The other has some very interesting data out of U C. San Diego that shows that in the bone tumor micro environment.
The prostate cancer bone bone metastasis that when <unk> is one of the absolutely most highly over express proteins and so we see the receptor for went Friday received went Friday.
And that forms a nice rationale for prostate cancer.
Excellent. Thank you so much for the very thorough answering thanks for <unk>.
Mmm, you're welcome Brian .
Our next question comes from the line of Kumar Roger with Brookline Capital markets. Please proceed with your question.
Hi, I'm <unk>, thanks for the update uhm.
Could you provide some color to the 216 program what does the strike if you could take it further.
<unk> collaboration so partnerships.
And also there were two patients that demonstrated <unk> and are there any other patients that are showing a similar response. Thank you.
Oh, I'll, let Celine comment on the patient first.
Yeah. So we still have you know two patients are still.
T. R. One has been off statement and continue to be in C. R. After eight months is eight months of <unk>.
<unk> and the other patients are still on some C. R on <unk>.
And we're gonna continue giving us a drug to just patience and maybe a compassionate use program. Since you see are still durable.
[noise], yes.
So as far as the program is concerned.
We have as we've announced where we're focusing our clinical programs, particularly on Missoula word amount phase three study.
However, we do have a an NIH grant.
Which we are collaborating with some academic investigators, including the discoverer.
Of this form of inhibition, Jeff Touretzky to do further work on the mechanism.
The the puzzle for US is that we are we are inducing these dramatic responses, but only in a very small percentage of cases and so.
We feel that it's necessary to know more about the.
The mechanism and so we have a non dilutive source of funding for that for that research.
There is an open I N D to.
To continue to study TK 216 at 216 in China.
Through our collaborator Shanghai pharma and we expect that study two Ewing sarcoma to get a ticket to open soon and we expect they'd be doing some additional biomarker work and such to try to understand mechanistically what's occurring.
Thank you that is used for.
And also what's the cut off date going to be able to save <unk>.
And how many patients do you expect to include in that.
And what are the expectations in terms of.
<unk>. Thank you.
What were you asking the cut off date.
Yeah.
Yeah. So so as you can imagine.
The posters are due to ask go on May 16th and so we've we've we've tried to go as late as we can and still processed the information but.
The contents of of what we're going to present are still embargoed by ASKO, so, but but there would be updated information compared to the ash meeting.
Four.
Both vll in mantle cell, including a.
More mature look at progression free survival and also further look at.
Interesting some subset analyses.
Take your time.
And finally, just regards to the dental Farber collaboration.
Please provide some color to the kind of agreement this is.
And you know any other details with regards to the kind of capacity to have and the timelines of manufacturing.
When do you think you'll have the person that.
Thank you.
Thank you. So so it is a is a.
Collaboration and manufacturing agreement.
May recall that we're using a bench top.
Processing system.
Called the maintain the prodigy and that is that's technology that the group at the Dana Farber have quite a bit of experience with.
And they they they own their own crowd of G equipment and so.
The we we expect that by the time that we submit our I N D.
At <unk>.
Several.
Performance characterizing runs will have been performed at the Dana Farber and that they will be ready to they will be ready to manufacture.
As soon as sites are open.
Able to enroll patients.
There will be they they have indicated that they can handle capacity both srom sites in the Harvard system and site outside of Massachusetts, and so we're very we're very happy with their apparent capacity here for.
Phase one program.
Thank you so much for taking my questions.
Thank you for your questions. We appreciate your call today.
There are no further questions in queue I'd like to hand, Nicole back the amount is made for closing remarks.
Thank you everybody. This is Jim bright Meyer and so on behalf of Richard Vincent Saline Goss G and everyone in a turn off I.
Thank you for your interest and participation today have a have a good day and we look forward to catching up with you in the future.
Pretty decent gentleman. This does conclude today's teleconference. Thank you for your participation you may disconnect your lines at this time.
A wonderful day.
Mmm.