Q1 2021 Calithera Biosciences Inc Earnings Call
[music].
Hello, I would like to have the confidence over to your first speaker today Stephanie wall. Please go ahead.
Both task good afternoon, everyone and welcome to our first quarter of 2021 conference call. So anything today or Susan Mona found your President N T O N K, sorry for of Chief Medical Officer.
This afternoon, we issued a press release, which included an overview of first quarter of 2021 financial and operational results, which can be accessed of our website account there of dot com before we begin I would like to remind you that today's discussion will include statements about our future expectations plans and prospectus. The constitute forward looking statements for purposes of the safe her.
Ever provisions under the private security of Litigation Reform Act of 1995 actually results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factor section of our periodic filings with the SEC.
In addition, any forward looking statements wrapping that review the only as of today and she that'd be relied upon as representing our views as of any subsequent day well, we may like to update the forward looking statements at some point in the future. We specifically disclaim any obligation to do so you've never vs change. Please note that this call is being recorded and with that I'll turn the call.
Over the Susan.
Okay, Stephanie and good afternoon, everyone. Thank you for joining up today on our first quarter of 2021 conference call.
On behalf of the entire thing I'd like to say, we hope that you and your friends and family for a name of healthy.
That's the world continues to push forward to contain COVID-19, we are grateful to the scientist companies in front line workers day of work to achieve monumental milestones and developing and deploying vaccines.
Their dedication has allowed many of us to return to some sense of normalcy and allowed people to return to their medical centers for treatment of serious illnesses like cancer and cystic fibrosis for account there is working to develop novel drug therapy that will make a difference to patients.
In the first quarter, we have been busy advancing are two key clinical programs, which both have date of Readouts expected later this year.
First the randomized keepsake trial has continued to enroll non small cell of lung cancer patients keep.
Keepsake is evaluating <unk> that in combination with standard of care chemo immunotherapy for first line non small cell lung cancer patients with keep one or nerf two genetic mutation.
We anticipate releasing interim data for this trial in the fourth quarter of 2021.
We also continue to evaluate toga on the staff an additional indications in combination and on the investigators sponsored trial.
Secondly, R. R O arginase inhibitor of C. V 280 for the treatment of assist the cry breakfast is continuing to enroll patience and the faith one be dose escalation trial.
As you know our interest in ardsley stemmed from the inside of 11 58 molecule that his partner with and being developed by inside for the treatment of cancer.
<unk> also plays a critical role in cystic fibrosis airway disease, and the arginase inhibition it could be a potential treatment.
We identify the T V 280 at first in class oral arginase inhibitor Holy on your bike, how Sarah for evaluation and the patient population.
According to the third party market research there are over 70000 people living the C. F. A mother of been recent advances in treatment with the C. S. P. R modulator, many patients they'll have impaired lung function.
As an area of Ah net need for people with the yeah. The C.
C V 280 of coins to potentially pick up <unk>.
We expect to announce data from our ongoing trial in the second half of 2021.
We're also free to have the support of the cystic fibrosis Foundation, including an award of up to $2.4 million for the clinical development of C. V 280, and look forward to continuing to work with them.
With our broad pipeline and milestones expected this year in the coupon or two N. C. F program, we're looking at an exciting 2021.
<unk> has always had an exceptional discovery research and development team and pair of with our experienced the management team the first and their capabilities, where you could afford to head and our vision to provide novel therapeutics in areas of high on that day.
And with that I will pass the call over the teeth for additional details on our clinical programs.
Thank you Susan.
Start by providing an update around total run of fifth or the termination editor, we are evaluating telephone of set in the non small show of lung cancer patient population, where the targeted farmworker driven approach and the kids to trial.
And the last couple of years retrospective analyses of shown the non small cell lung cancer patients.
We're nerf two mutations have four of prognostic outcomes and wild type of patients and the these patients may not respond well to the standard of care cymry of interference.
Coupon nerve to driver mutations protect your mother's from oxidative stress and promote tumor growth of survival.
Preclinical models of showing the activation of the coupons nerve to password makes tumors dependent on the determination of activity for gross and survival, making these tumors exquisitely sensitive to inhibition of retirement ex activities I totally understand.
And the case a trial patients of randomized to receive told one of us that work with you, though in combination with symbolism of Carboplatin and Pemetrexed.
The study will evaluate the safety an investigator assess PFS of told one of the staff plus the standard of care came out of new therapy regimen.
On on Rolling 120 patients and begin enrolling the stuff.
Eddie in September 2020.
This is an area of Unmeant clinical need as an estimated 20% of non screamers non small so on cancer patients have tumors harboring keep one or two mutations.
Based on frequently the studies that provide of strong mechanistic rationale.
For the central role of contamination, driving proliferation, and non small flow lung cancer tumors hardware and keep one nurture mutations.
We believe that the keeps a trial has the potential to improve outcomes for these patients and we look forward to being able to share interim data on the fourth quarter of this year.
We're also continuing to assess the combination of tofu on the staff with the CDK four six inhibitor power cycling and non small cell lung cancer, colorectal and pancreatic cancer patients and exploratory phase one of you to trial that we're conducting in collaboration with Pfizer.
Earlier this year, we announce results from the cantata trial, which evaluate a total of ISTAT with Cabozantinib and and all kind of the population of reynoso of carcinoma of patients that have progressed on immune checkpoint inhibitors or antiangiogenic therapies. This trial did not mean its primary endpoint of improving the progression free survival.
The final analysis from the study will be presented at the ask of annual meeting of June.
While we're just we're disappointed with the cantata results. We believe the study as of the field by presenting outcomes of contemporary population of patients treated with Cabozantinib in the second or third line Center and we look forward to presenting these data at osco.
We have no plans at this time to continue developing telephone of staff in Reno salt carcinoma.
Moving on to cystic fibrosis, and 2020 renounce initiation of the first clinical trial to evaluate our novel Errol Argenis inhibitor C. V 280, Mcf patients and enrollment has been proceeding as planned.
The depletion of arguing and cystic fibrosis patients by the end of a margin is results in reduced production of nitric oxide and increased production of polyamine and programming.
The inhibition of arginase.
Should increase nitric oxide increased antimicrobial effects and improve every function.
Preclinical studies demonstrated C V 280 treatments significantly improved lung function and reduced lung infection and she of TR deficient price.
The phase one the studies enrolling approximately 32 patients that are on a stable regiment of CF therapies and have chronic airway dysfunction.
And it'll be randomized to receive either placebo received <unk> induced escalating cohorts.
Importantly of the trial is designed turn to demonstrate the district can safely be added to existing standard of care therapies for.
Including the Cotr modulators.
We plan to share data from this trial on the second half of 2021.
In addition to these ongoing clinical programs, we have clinical candidates for both an oral CD 73 inhibitor CB seven or eight and four I warn inhibitor see the 668.
Which targets peroxide kind of rhenic acid immunosuppression and the tumor microenvironment and we are continuing these preclinical studies.
With that I'll pass it over the Stephanie for an update on our financial.
Thank you Keith.
Keith of financial results for the current corner were included in today's press release I will briefly review of results on this call.
Hello, Karen means well capitalised with cash in investments totaling $102 $9 million of March 31, 2021, and the expensive we're $15.3 million in the first quarter of 2021 compared to the $21 million on the first quarter of 2020. The decrease was primarily driven by decreases and the total is glynn of staff and I'm, hoping for the program.
Gmail expenses were 5.4 million in the first quarter of 2021 compared to 4.9 million in the first quarter of 2020. The increase was primarily related to the increases in personal related costs, partially offset by decreases and professional services.
Net loss for the first quarter of 2021 was 20.4 million on with that I will now return the call back over the Susan.
Thank you Stephanie and with that upgrade the we're happy to open the line for questions.
Okay. Thank you as a reminder to ask the question the Express Star one on your telephone keep that.
Against the us of question, you'll need to press the one on your telephone will pass for just a moment to compile the Q&A roster.
Our first speaker, our first question coming from the line of <unk>.
Of city.
Sort of your line is open.
Hey, guys is James of Lois day for taking my question.
Just two quick ones for keepsake.
Sort of given us the expectations for the control arm. The can you sort of consider can you share like what you would consider to be good or on PFS data for the the patient call in silhouette of that and.
And then related to keepsake the.
For the fourth two readouts.
Replay the least the data in the press release or is that something that you could reserve for like.
Lots of your medical conference six.
Hi, James.
So in terms of the data, yes, we've talked about before kind of of what we would expect the ballpark to be for the control arm.
Maybe the medium PFS in the three to five months range.
In terms of what good data looks like I mean, I think the key point is that we're looking for this to be a substantial improvement over over the control arm and over over.
How poorly of these patients do today, so we're really not looking for.
Really small incremental improvements.
I hesitate to provide of specific number or a specific GFS.
But.
The goal here is for it to be clear improvement and we're not looking for something subtle.
On.
Presumably.
When all of a sudden the not something you need of a statistician to determine the that put it that way and.
And then in terms of how it will be done.
I think we're not.
Necessarily going to wait for a medical conference will see what what based on the timing on how that how that works out.
Got it appreciate guys. Thank you yes.
Yes.
Thank you next question from the line of map hips of.
William Blessed.
Your line is open.
Hi, guys. This is Rob Andrew here on the.
<unk> just a couple of if I may so first one the.
The interesting presentation.
A couple of weeks ago.
<unk> that was kind of I like the startup post as a keep halfway through which diesel immediate killing of tumor cells of cause and it seems in the literature of that there's some evidence add the.
The nurse too could be involved in this past week since it's kind of come to regulate goodbye glutathione and then similarly, the exports of interest sorry. The glued to me has been linked to the question of of the policy of as well. So we were just kind of wondering whether you've seen any evidence pre clinically the type of going to start can influence the throw up ptosis pathway on what.
The this potential to thank you that that could be an additional mechanism of action.
<unk>.
And then the second question is just.
Kind of similar to a previous question on keep state, but on the C. B two eight T.
Just on one of expectations all of that in terms of the data is the in conjunction with the medical meeting or you know we expect the top line results press.
Press released thanks.
Yes, Hi, Rob.
Yeah. So I think the the story around for a processes of interesting one and certainly of developing one eye.
I think not an area of focus, particularly earlier on in the development of the program when when much of these data were generated of it I think that might be a good conversation for for ahead of research Frank Pilates to discuss further but in terms of our clinical studies again, it's not something we've looked at their in that context.
So something we're very interested in and we certainly think.
Given the relationship.
In both as you say, both glutamate and and the nurse.
Two pathway with fur of ptosis on that this is potentially of very interesting mechanism, but not wasn't central of I guess to the to the early date of that.
Put together a free clinically at the time that we did that it's really emerged over the last year or two.
So I guess I would say.
To be determined, but certainly very interesting and then in terms of of Cvs of 80.
Again.
Well, we'll let you know I think are are approached generally is too.
Inform on if.
If we are going to be reported and yet at a conference to do that once we have.
Been accepted to that conference so.
We.
Well, we'll let you know I guess is that the.
Which is.
Great. Thanks for taking the questions.
Okay.
Thank you again to ask the question. Please press the one on your telephone.
Most of question from the line of Nick Abbot was Fargo Securities. Your line is open.
Hi, guys, it's Joe on for Nick Congrats on the progress on I. Appreciate you taking the question.
Just quick one from US apologies if I missed it but have you provided an update on the NCI sponsored.
The Grisso combo study.
The on Quinn trials. The primary completion date is is second quarter of 21, so should we be expecting date of prior to the keepsake read out or maybe how should we think about that.
Yeah. Thanks, Joe.
For if all of our sort of external studies that we don't sponsor, including she's have studies, it's hard for us to comment much on the timing so no we haven't.
Released any data and it really wouldn't be even our data to release, but but those date of have not been discussed.
Publicly and to be honest, we don't have it sounds like we're in constant communication on have total visibility of that.
So that'll be on the.
The Ncis timeline.
I can't really speak to that right now.
But.
As far as we know these are moving along well and there are no issues, but we just don't have specific date of the to talk about today.
Yeah, the understood Keith I appreciate it thank you for the comforter.
Okay.
Okay. Thank you.
Against the US of question. Please press stolen on your telephone.
There are no for the question of this time this continue.
Okay. Thank you thanks.
Thanks, all for joining today and have a good evening.
Great. Thank you and that concludes the these conference call.
Thank you for participating.
We will now all of disconnect.
[music].
[music].
[music].
[music].