Q1 2021 Oncternal Therapeutics Inc Earnings Call
[music].
Welcome to your internal Therapeutics ink first quarter 2021 financial results call. All lines had been placed in a listen only mode on the floor will be open for your questions and comments following the presentation.
If you should require assistance throughout the conference. Please press Star then zero at this time. It is my pleasure to turn on the floor over to your host Richard Vincent Sir the floor is yours.
Thank you Melinda.
Good afternoon, everyone and thank you for joining us today.
Joining me on the call this afternoon, or our president and CEO Doctor James Reitmeyer and are acting CMO darker Edwina Baskin Bay.
We welcome all of you today's call includes a business update and discussion number of 2021 first quarter financial results, which will be followed by Q&A.
Today's press release and a replay of today's earnings call will be available on the Investor Relations section among terminals website for at least the next 30 days.
We also power or 10 cute from the first quarter of 2021 earlier today.
Please note that certain information discussed on the call today 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 to the risks and uncertainties associated with our business.
These forward looking statements should be considered in conjunction with on our qualified by the cautionary statements contained in today's press release, and our SEC filings, including our form 10-Q for the quarter ended March 31 2021.
This conference call contains time sensitive information that is accurate only as of the date of this live broadcast may 6th 2021.
We undertake no obligation to revise or update any forward looking statements to reflect the events or circumstances occurring after the day of this conference call.
With that it's my pleasure behind the call over to our C. E O Dr. Jim Bright Meyer.
Thank you rich and good afternoon, everyone.
<unk>, we are committed to developing novel treatments for patients with cancer, who have critical unmet medical needs.
We are advancing a robust product pipeline with clinical and preclinical product candidates to target several such cancer indications our development efforts focus on biological pathways implicated in cancer, Genesis and or progression.
We are particularly pleased with progress made during the first quarter of 2021 to advance the development of some choose a man or investigational potentially first in class humanized monoclonal antibody that binds with high affinity to a biologically important epitope on Roar, one also known as.
Receptor tyrosine kinase like orphan receptor one.
Encouraging updated interim clinical trial results with serve choose a map plus packs a castle in patients with advanced her to negative breast cancer were presented at the American Association her cancer research or ACR annual meeting.
From Tuesday May have also demonstrated single agent activity and enhance the any deliberative effect, a commonly used chemotherapies in preclinical studies of ovarian cancer, including platinum resistant cells in another presentation at a C. R.
Are clinical trial assume twos amount plus a group nib with patient impatience with mantle cell wasn't on lymphoma R. M C L or chronic lymphocytic leukemia or C. O L continues to progress and what <unk> was selected for presentation at the American Society for clinical oncology.
<unk> or <unk> 2021 annual meeting.
And we will provide additional details on each of these.
<unk> has become an increasingly visible target in the oncology space recently, and we believe we have one of the most advanced and diverse pipelines targeting bar one.
One reason for this attention with two major acquisitions in late 20th 20, the Behringer Ingelheim acquisition of N. B E Therapeutics, and it's N B E. T O O two raw, one targeting antibody drug conjugate or a D C.
And the American company acquisition of by <unk>, Inc, and Vll's one on one it's raw one targeting a D C.
Via last one O. One utilizes some choose a map to target Roar, one and was invented and had its initial development at on terminal until we spun out bellows by.
[noise] separately, we are continuing to support two investigators sponsored clinical studies at U C San Diego.
First a phase <unk> clinical trial of some choose a mab in combination with paclitaxel for the treatment of women with her too negative metastatic or locally advanced Unresponsible unresectable breast cancer and second phase two clinical trial of serve choose a man in combination was the need of clocks.
A b C L and two inhibitor impatience with relapsed refractory C. L L.
We also continue to make solid progress on I'm turtles, investigational roller one targeting car T cell therapy program.
In January we announced a research and development collaboration with the Karolinska Institute in Stockholm, Sweden, too advanced novel <unk> targeting Carter.
R T and car N K cell therapies from the laboratory into the clinic.
In addition, we announced an agreement with <unk> technology to manufacture clinical grade Lindsey viral vectors to support and accelerate on internals Investigational War, one targeting car T cell therapy program.
These these agreements are in addition to our existing collaboration with U C. San Diego under a grant from the California Institute of regenerative Medicine, and a partnership with Shanghai Farmer.
We are tremendously excited by the potential of cell therapies targeting blood, one which may allow the selective targeting of tumor cells that express where are one while relatively sparing healthy tissues.
We also advanced the development of T. K 216, or investigational targeted small molecule inhibitor of the E. Twenty-six transformation specific R. E T S family of uncle proteins.
We were pleased to learn that are updated clinical data from this study was accepted for an oral presentation at the ask 2021 meeting.
With that I will now turn the call over to rich Vincent R. C F L to review our financial results.
Thank you Jim.
In October 2017, CERN awarded an 18.3 million dollar grant to the researchers at the U C. San Diego School of Medicine to advance our base one too clinical trial evaluating from two some app in combination with a broken hip for the treatment of patients will be so lymphoid malignancy.
He's including M. C. L M C L L.
We are conducting a study in collaboration with U C. San Diego and I expect to receive approximately 14 million and development milestones under research sub awards throughout the award period.
In conjunction with this award or Grant revenue was point 7 million for the first quarter ended March 31 2021.
Our total operating expenses for the quarter ended March 31, 2021 or 6.7 million.
Research and development expenses for the quarter totaled 3.9 million in general and administrative expenses total $2.8 million.
Net loss for the first quarter was $5 90 million.
For a loss of 12 cents per share basic and diluted.
As of March 31, 2021, we had $111.2 million in cash and cash equivalents.
We believe these funds will be especially to support or operations into 2023.
As of March 31, with 49.4 million shares of common stock outstanding.
Now I will turn the call over to darker Edwina Baskin day.
Thank you rich.
I would not like to highlight data presented at the a H T R.
2021 annual meeting and the upcoming milestones that we expect to reach over the next several months.
So let me begin mentioned, we continue to support essays, one day clinical trial in combination with Paclitaxel cause it treatment of women with her too negative metastatic or locally advanced unresectable breast cancer.
And then a a T R.
B U C. San Diego investigators presented results showing and objected response rates are 57%.
With an encouraging toxicity profile.
These results were consistent with the previously reported interim results of the study.
And compare quite favorably to historical results for single agent Paclitaxel input.
In particular for patients such as those who had received a meeting at six prior therapies from metastatic disease.
The trial is expected to be completed soon with one additional evaluable patients to be enrolled for a total of 15 evaluable patients.
[noise] also at a a C. I. This year, we presented data from the preclinical study investigating some choose a map in combination with chemotherapy take agent cisplatin and Paclitaxel.
Used to treat high grade serious ovarian cancer and endometrial cell lines in vitro.
Seven two to Nab demonstrated single agent activity and enhance the anti proliferative affects the chemotherapy take agents in both ovarian or endometrial cancer cell models, including those that were platinum resistant and ovarian cancer.
We expect further preclinical data in a dish in additional or one expressing too much to be available on the second half a day this year.
2021.
Ah clinical data update from our ongoing phase one to trial <unk> plus ibrutinib for patients with mantle cell lymphoma was selected can be presented at the <unk> meeting.
On June 7th of this year 2021.
Also a clinical data from our ongoing phase one to trial on T. K 216 for patients with relapsed refractory Ewing's sarcoma with selected for an oral presentation at the ask on me came on and this will be presented on June 4th.
2021 at 11 30 in the morning Eastern standard time.
We also expect further preclinical data in additional E. T S driven too much to be available in the second half of this year 2021. We are currently targeting to treat the first patient with our war one car T cell therapy, and the first half of 20.
<unk> 22 next year.
I will now turn the call back to R. C E L Doctor Jim Brighten on there.
Doctor Reitmeier do you may have your mute button.
Thank you Melinda Thanks, and thank you would rena in closing we have a strong balance sheet with multiple potential catalyst in the next year and a clear priority of deploying our financial and operating resources to develop promising candidates in rare and common cancers. We look forward to updating your during the remainder of 2021.
On.
Thank you for joining us today uhm with that I'll turn things back to Melinda for the Q&A portion of this afternoon's call.
Thank you the floor is now open for questions. If you do have a question. Please from Star then why not on your telephone keypad to join the queue, if you're using a speaker phone. Please pick up your handset to provide the best sound quality again, ladies and gentlemen, if you do have a question or comment. Please press star than one at this time and walk.
Two of her cash sang with Oppenheimer for our first question. Please go ahead.
Good afternoon. This is Jackie at four Hearts per day, thanks for taking our questions first just on your uncle higher on your cheek, but an officer on it. It was the client lie there and what kind of policy are experienced are looking for also I'll put some avenue.
<unk> I know you will update IOSCO, but just you know based on your current discussions with your K O L. What are some additional stated are set do need to get from four and they are going through that.
Discussing the.
That there.
<unk>, Colorado.
[noise]. Thank thank you for the questions Jackie Uhm, we're we're very happy with the recruiting process.
For a full time C. M O. Although I have to say that we could not have been luckier than to have Edwina Baskin Bay join us as in acting C. M O.
As she kindly did while the search was underway. She has been a a spectacular addition to the team.
We do we were getting a great candidate uhm and what we expect to be in a position to announce a fulltime CMO recruit with extensive oncology experience some time in the near future, but as you know of course.
Sort of recruiting is only finished with the signing on the very last a document.
So with the Jackie your question on mantle cell lymphoma is basically when when do we think will be ready to continue our dialogue with the F. D. A about a potential registration path and the answer to that question is no.
Now Uhm, we are we are continuing our dialogue with the F. D. A about potential accelerated approval in full approval alternatives and if those if those discussions are timely than we would hope to be able to have something to.
To discuss with you and the second half of this year.
Mhm.
If you were very helpful and I'd also set out there converted for updated our current status of that.
Author trial.
Very good day.
This will ask you know what are your solids.
That trial for yourself.
The type of patience, you want on <unk> interferes or trial and it seems like in a car and if I could get a sponsor courses. That's how included both chemotherapy true and also payments herpes naive patient just any color on that on on that aspect.
Sure Edwina I think I'll take this so so your question is going forward in breast cancer and this particular study in her to negative patients did did did include patients with a median of six price.
Near treatment and and so they were extensively heavily pretreated some of them have been through multiple uhm hormonal intervention, while others have as you said been treated with chemotherapy.
But in any case extensively pretreated and so we will be breast cancer is one of several indications that we are taking a hard look at right now and establishing priorities based on a full assessment of market <unk>.
<unk> regulatory pathways, I'm competitive landscape science and clinical considerations and our our plan here is to have an analyst a day later this year, where we lay out our thoughts about breast cancer and other indications and.
<unk> priority setting and in particular is around potential clinical trials.
While they're fault ways that they look forward to that and and the last question is teekay from is maybe gave us on <unk>.
A cough or is that posts that put in for your potential fast the market strategy.
Fort Teekay from 60, an additional indications I guess growth.
This day or medical the perspectives wasted stark hold on indications Boucher can mimic yoani sarcoma as well.
Follow up question.
Sure Jackie so so we think that there was an interesting analogy for a very rapid approval by the F. D. A N a in a sarcoma indication and that is taz varick brought forward.
By F design and a single arm study in epithelioid sarcoma of 62 patients was sufficient to achieve accelerated approval. So so we do the view that as a potential best-case analogy in a rare.
<unk> sarcoma with a substantial unmet medical need.
Yeah.
I apologize.
[laughter] next week on the line of a call Burns with Northland Capital markets. Please go ahead.
Thank you congratulations on your progress a couple of my questions have been answered that I was just curious have you had any comments with respect to the progression of enrollment with <unk> solid form of patience on this <unk> study concerning that that was expanded for M. C. L. And then also with respect to two two.
16 enrollment was progressing very well there despite COVID-19 and I'm I'm wondering if there's any updates that made the cases I imagine it would be and with respect to <unk> falls followed up study.
To that say what might be done in terms of limiting extensively heavily pretreated population Ewing sarcoma. Thanks.
Do any of those you can you can respond to Carl.
Hi call. Thanks for the the the question and I'll start with the last one person first on my mind Tuesday at 216.
In terms of enrollment we have been enrolling really quite well thanks for for realizing that too cozy and we continue to get to to do so as a part of our sales too expansion cohort and we will have an updated number for you on that.
Uhm expansion and NASCAR.
<unk>.
And as it relates to the type of patient population I believe is your vanilla here on the previous day that we have been treating heavily pre treated patients.
We can do a median uhm lines of therapy from previous.
Presentation to two or three median line and metastatic disease.
And as we're we're starting to to notice Blair 90, more advantageous we may be able to delineate that as part of their and investigate more but I would say just stay tuned Glasgow presentation.
Now the first question I believe it has to do with M. T. Albert call I think you're gonna have to repeat it for me [laughter] Oh, Yeah. No worries. Thank you that was very helpful. Just with respect to enrollment with M. C. L patience and if I recall correctly from the initial structures subtle trial. It was expanded to include more on T O patients given.
D O R. C. R response thanks.
That's that's that's that's that is correct and we can can you to to do so as you're aware C. L. L is as close to a moment and we're following up with his patients longterm and will continue to to show that day that each at each update an M. P. L. Again on the same two expansion.
N as in rolling really quite well and you'll see an update on the numbers at <unk>.
Great. Thanks on again, congratulations on the progress.
Thank you Carl Thank you. Thank you.
Next week on the line of Rob Burns with H C. Wainwright. Please go ahead.
Hi, guys. Thanks for taking my questions and congrats on the corner three from me if I marry so the first one being around the potential in solid tumors for sandwiches that plus I chemo agent. So <unk> you said earlier, we're supposed to or that we will get a sort of we'll get some color around your sort of strategy in that or.
<unk> later this year I think analysts day I was just curious type of goodbyes any color on when do you think you might initiate a phase one to trial in solid tumors, whether it would that could be late 2021 or early 2022, and then I'll stop there and I lost my questions. After the response yeah.
That's fine Robyn happy to have you go go on question at a time and thank you for the question. So so we we are potentially interested in an initiating additional clinical trials in solid tumors and at this point.
With everything else, that's going on and as you know we've been really accelerating our car T program I think that it could be late late this year or early next year that we initiate additional studies. We haven't started actively opening studies at this point and as you know.
No it can easily take more than six months to get something happened.
No.
<unk> color My second question. So I know, we're supposed to see some incremental <unk> for you know both Sir I'm cause I have lots of Bruton as well as the T. K 216 can you provide any you know sort of granularity into what we can expect from the increase in patient numbers there.
So it's <unk>, that's embargoed of course, uhm, but I think in for both M. C. L. On Ewing sarcoma. There are I think you'll find uhm substantial numbers of new patients that will be reported at ask compared to previous disclosure.
<unk>.
Okay not a problem. My last question is regarding your discussions with the F. B, a I'm just sort of curious.
You believe that you can potentially modify the phase to to make it registrational or whether you'll have to or on a separate phase two trial and what sort of proposals have you put forth to the F. T. A with regard to trial design.
Sure Rob So so I think that it's unlikely at this time that we would continue the existing study and a a new study with with with a registration potential is is more likely for a for a number of of.
The reasons that I think you'll you would you would agree with window when when we get to that point and.
And so we we have discussed single arm and randomized studies with the F D, a and and various control groups and so so where it's really it's been a really good dialogue would that be a we've got really helpful feedback from them and so we're we're continuing to do.
Discuss study design right now and <unk> and I'd say that I I'd say that it's most likely that you would see a new randomized study is the most likely design.
Awesome, Thanks, guys and congrats on the corner again.
Alright.
And we take our last question from Tomorrow Rasher with Brookline capital markets. Please go ahead.
From a graduation friend that thanks for taking my questions.
With regard to the solid kind of set a date preclinical data.
Can you provide insight with regard to like walk indications. This will be on you know what combinations.
It would it be alright.
Alright, I'll claim from South Sienna stick efforts by proceeding obedient guidance.
How do you think that can be replicated hurting human trials do you think they need to be <unk>. So that they can be both at the same time, just trying to get your thoughts on how how that will be implemented.
Thank you for the questions Kumar. So we are where we are in in process for this ranking exercise in solid tumors. What I can tell you I'll I'll I'll tell you. Some examples that were considering and these are they're they're not.
Finalist yet, but they're they're in the running so ovarian cancer combined with potentially.
Taxol or platinum as a possibility lung cancer on combined with O C. Martin M. As a possibility breast cancer combined with Paclitaxel remain something that we're quite interested in and and so I think those are those those are <unk>.
<unk>, where raw one expression is high and the and the tumor road. One activity has been demonstrated and started Tuesday may have activity has has has some been demonstrated in preclinical models and so there <unk> that makes them.
All interesting to us.
I didn't put her on the road one party program, how are things going on in China, I like how they opened up but what are we going to start off there.
And they don't go on that you are planning first off drinking too what needs to be done before a doctor and start.
Thank you Kumar so so uhm, where we've really made substantial progress inside and outside China and and so are are friends and colleagues at Shanghai farmer.
Have been doing some significant uhm preclinical work they have a dedicated biologicals group that is responsible for the car T program. You may have noticed an endpoint news article that came out earlier this year Shanghai pharma on.
<unk>, a 2 billion U S commitment to build out a 3 million square foot biotech park in in Shanghai Province, and Interestingly in this endpoint article the programs that the spokesperson from Shanghai <unk>.
Mentioned would be going into this biotech park, we're the roar, one car tea and some choose a man and so there's there's substantial work and investment come on going on with Shanghai Uhm, We're happy with their progress. We're also happy with our own internal progress, including the Carolyn.
<unk> and led to Jim collaborations and we're happy with progress made at U C. San Diego in their work with construct design and thinking about they would they would they would love to be the first clinical trials site in the United States. So I'll I'll really all on.
All of.
Of the different aspects of the car T program are progressing nicely.
And maybe finally income from the antibody supply Kenny prorated update like where it'll be on how much I'll play you hiring that'd be fluffy shouldn't put all ongoing trials on flying files. Thank you.
Alright. Thank you for the for all of your questions Kumar Uhm and so antibody supply is good uhm, we have recently.
Produced another batch successfully uhm with the highest tighter and yield and the and the best purity that we've ever had and so with that batch we have a a very ample supply of antibody for at least two years and potentially.
More than that.
And where and I'll say that we're very happy with our collaboration with Wuxi Biologics, who is our antibody manufacturer. They have been a very good strategic park.
And with that operator, I think that may be the last question that was the last question. So well turned to Doctor Bright my airfare closing remarks.
So thank you everybody for your time and attention. Thank you for all of the questioners for interesting and insightful questions on our program. We look forward to updating you again with our second quarter results in the future and I appreciate your attention.
To turn it off and on ambition to help patients with some of the worst cancers and with that goodbye for today.
Thank you. This does conclude today's teleconference. We thank you for your participation you may disconnect. Your lines at this time have a great day.
[music].