Q1 2020 Earnings Call

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<unk>.

Oh light to hand, the conference over to your speaker today, Miss Jennifer Mcnealy.

You may begin.

Thank you [laughter].

Let's see good afternoon, everyone welcome to our first quarter 2020 conference call. Joining me today are Susan Mono, our founder President and C.O., Keith Orford, Chief Medical Officer, and Stephanie long Senior Vice President of Finance.

We've issued a press release and it can be accessed through her website at Calithera dot com before.

<unk> began I would like to remind you that today's discussion will include statements about our favorite future expectations plans and prospects that constitute forward looking statements for the purposes of the phase her.

Rubber provisions under their private Securities Litigation Reform Act at 1995.

Actualresults made there for material from the indicated by this.

Forward looking statements as a rule delta various important factors, including those and the rest factors disgusting the rest factors section of our quarter <unk>.

Port on foreign 10, Q. file with the S.P.C.

In addition, any forward looking statements represent our views only as of today and should not be relied upon his representing our views as any subsequent day, while we may elect to update these forward looking statements at some point in the future if.

Specifically to claim any obligation to do so even if our views change he's noticed calls being recorded and with that I'll turn a call over to Susan.

[noise]. Thanks, Jennifer good afternoon, everyone. Thank you for joining us today on our first quarter Twentytwenty Conference call.

On behalf of the entire team I'd like to say, we hope that you and your family's remain healthy while the world addresses the challenges the code 19 pandemic.

Today on this call. We're all working from our homes as has been our practice now for a number of weeks and compliance with the C.D.C., California State guidelines and San Mateo County, five times.

Diligently coordinating our activities to maintain ongoing business operations look forward to going back to our onsite operations as soon as we can do so safely.

<unk> there we are building an integrated biotechnology company that develops novel small molecule uncle metabolism drugs.

Drugs that are targeting tumor and immune cell metabolism pathways for the treatment of cancer and other diseases.

By building a pipeline of novel therapeutic proud of candidates, we're creating multiple opportunity to positively impact clinical outcomes for patients and drug development programs towards commercialization.

We are the first company to take a selective glutaminase inhibitor into the Clinton on the first to demonstrate click.

Uncle activity and cancer patients, including proof concept for the activity. It's helped them sat in renal cell carcinoma in our randomized entrada of trials.

We have volume rove, the telling gluttonous that can how to trial a study with registration potential in renal cell carcinoma patients.

Was a step closer to becoming a commercial biotechnology company.

But can probably trial was full your mold in October 2001 team.

And we advised at that time that we plan to report tough one African C. and safety data from the trial in the second half of 2020.

Delays associated with covered nine to update it <unk> to expect top line so that in the fourth quarter of 2020.

Along with affirming that could leave out as expected by the one with Twentytwenty you updated guys and allows for additional time for activities that requires visit the clinical sites, including.

Made them on.

And this quarter. We also made continued progress towards initiating a randomized trial mm first line.

Non small sound lung cancer patient harboring genetic mutation humor or keep.

Mutation of the keep one nerve to pathway presence in approximately twice you frequently tumor.

Nonsmall, so lung cancer patients and is associated the core survival and resistance the standard of care therapy.

Activation at this pathway lead to reliance upon some comedy.

Activities and sensitized itself to contaminate inhibitions <unk> that.

Given the challenges associated with opening new clinical study during the current stage is the total 19 pandemic we.

Expect to be getting home and in the third quarter of Twentytwenty.

Trial and practice abstract describing the study design has been accepted for presentations at the American Society of clinical oncology Twentytwenty virtual meeting.

Land to present interim data from this trial in 2021.

Oh originate from Hitler I.N.C.D. 001158, or 11 58, it's the first originates inhibitor to enter the clinic.

<unk> isn't immunosuppressive enzyme expressed by immune cells in the tumor microenvironments.

At the as one meeting last fall the first advocacy day before just compound were presented demonstrating activity and providing proof of concept for argenis inhibitions for the treatment of cancer.

Pleased with the progress of this program as we continue in collaboration with our partner insight to continue clinical trials and seek to develop a first in class product for patients with multiple types for solid too much.

<unk> there has filed a complaint against insights into superior Court of California, San Francisco County.

Hurting claims for breach of contract arising evidence I found your to pay to milestone payments the company believe or do under the Queen.

We do not planning to Thomas further on matter at this time.

The timeline for the clinical trials on the program remain as before and have not been impacted by the filing of the complaint.

Fortunately, it's inhibitors also have potential in the treatment of cystic fibrosis. Accordingly, we have selected T.V. 280.

A unique oral arguments inhibitor for the treatment of cystic fibrosis patients.

It is a novel oral arguments inhibitor based solely on <unk>.

We have completed a phase one single offending dose trial to evaluate the safety probability and Pharmakinetic pharmacogenetic profile of or C.D. to Haiti in healthy volunteers.

Safe from be critical study and people was just.

Cystic fibrosis his toys to begin Saint openings are in progress and we expect <unk>. The first patient in the third quarter of Twentytwenty pending further development in the code 19 situation.

<unk> clinical stage programs, we have a broad pipeline and a productive r. and d. too.

We remain focused on producing novel drug candidates with the potential to be highly differentiated new therapies in areas on that and.

But that I would have to call over to see for additional details on our clinical crooks.

Thank you see.

Let's begin with them more detailed update on television sets are ugly termination inhibitor in our most advanced product candidate.

Currently focused on forging a clinical and potentially commercial for told us that and renal cell carcinoma.

In October 2019, renounce completion of and even Roman of Contardo, a global randomized double blind trial of told us that in combination with covers and then and second and third line or see see patients.

Contardo enrolled for 140 for patients ahead of schedule demonstrating that significant unmet need for Advancers you see patients in the second and third one setting.

Tata is designed to evaluate the African soon safety until then is that in combination with.

Haitians restrict upon by I.M.D.C. risk categories and prior treatment with an L.C.P.D. one P.L. one therapy.

The program point is progression free survival by independent review.

Survival will be assessed as a key secondary.

We haven't made a combinations to facilitate study conduct during the pandemic, including allowing patients to have scans performed at local financial centres to facilitate compliance with this study scheduled assessments.

Andrew receive a larger allocation of study drugs in order to reduce the number of visits required to chronicle site if necessary.

The trial has the potential to serve as a registrational trial.

And we expect to report top on results have been taught it in the fourth quarter of 2020.

We also believe told want us that has the potential to be developed in patients with nerve to keep one mutations.

Multiple invivo preclinical models have demonstrated that activation of this pathway through loss of function keep one mutations or again, a function or two mutation.

Cellarage to her formations friend.

<unk> aggressive the activation of the nerve to keep one pathway also make some sensitive to the inhibitions <unk> activity.

<unk>.

Recently presented in clinical data have demonstrated that activation of the nerve too cheap one pathway results in very poor outcomes and non small so lung cancer patients receiving frontline standard of care chemotherapy or chemo Indian or there.

Mutations in the keep one or two halfway our presence in approximately 20 per cent of non screenos nonsmoker lung cancers.

Based on the unmet need in this population we have designed a randomized trial and lung cancer patients, which we expect to begin and the third quarter 2020.

The study will evaluate tomana sat in combination with standard of care therapy, Chemo plus pembro.

In approximately 121st one metre static non screeners nonsmall someone cancer patients for tumors that harbor mutations in either keep one or two.

That he will include an initial safety running period and the code primary endpoints are safety.

Instigators this progression free survival.

A trial in progress abstract describing the study design has been accepted for presentation at the American Society clinical in College, you 2020 virtual meeting.

And interim analysis is planned and 2021.

In addition, initiate and see I sponsored trial evaluating single Asian telephone is that in patients with solid tumors that have nerve to keep one mutations is currently ongoing.

You're also conducting to exploratory phase one v. two trials in collaboration with Pfizer combining tells let us that with tells Jenna and with Iran's.

<unk> has been completed in both of these trials.

Expansion cards had been temporarily temporarily pause due to the covert 19 situation.

But we now expect enrollment to resume and the second quarter of 2020.

Next the originates from having a programs I.

I N.C.D. zero Zero 11, 58 also known as 11 58 isn't investigational first thing classroom you know on college, you metabolic checkpoint inhibitor trading Argenis immunosuppressive enzyme secreted by my would derive suppress herself or M.D.S.C. two blocks you sell activation tumors 11 58 is being.

<unk> insight into co development code commercialization collaboration.

11, 58 is being evaluated as monotherapies.

As well as in combination with timber lives man across eight cohorts or patients.

Front types of medicine addict or locally advanced cancer is not a minimal to local therapy.

The first data from this study were presented as no in September 2019.

Second ongoing clinical trial is evaluating 11 58 in combination with three different chemotherapy regimen.

Thoughts Jim side of things, just button or paclitaxel in patients with ovarian endometrial colorectal gastroesophageal unfamiliar attract cancers.

An additional trial in multiple my limitations treating patients with 11 58 foot stare at two am or dare tune them alone is also one going.

We are pleased with the progress of this program and we look forward to additional data updates from the 11 50 program in the future.

We're also developing an argenis inhibitor outside among college U.C.B. 280 isn't novel are conditioned habit or in development for the treatment of cystic fibrosis.

Under R. collaboration agreement with inside we retain room wide rights to develop origination heavy hitters and specific <unk> rare disease indications, including cystic fibrosis.

Originates has been possibly to play a critical role in the past pathophysiology of cystic fibrosis.

As well as several other non oncology diseases.

C.F. patients have neutrophil infiltrates in their lungs, and these neutrophils secrete high levels of Argenis.

Originates activity deplete charging which in turn depletes nitric oxide.

Nitric oxide or I know has potent anti microbial activity and <unk> has been shown to improve lung function when administered to see applications.

We hypothesized than inhibition of Argenis for the C.V. 280 can restore normal large name and N.O. levels and improve lung function in C.F. patients a concept that is supported by previous proof of concept clinical trials.

The phase one clinical trial to evaluate the safety Tolerability in front of kinetic profile oral C.B. 280 isn't healthy volunteers has been successfully completed.

Phase wouldn't be clinical study in C.F. patients, which is expected to start enrollment in the third quarter of 2020 will test multiple doses of C.V. 280, compared to placebo and approximately 30 adults you occasions to determine a safe, though strange for C.B. 280.

Patients with any C.F.T. or mutational status will be eligible for the study.

<unk> will receive C.B. 280, or placebo for 14 days. In addition to safety Intolerability other end points from food pulmonary you know production lung function and speed or microbes.

In a plan to phase to do is finding portion of this study additional cohorts of patients will receive different doses of C.B. 284, placebo for 28 days in order to select the optimal those I've C.B. 280.

For the entire studied patients will continue their existing therapies for C.S., including C.F.T.R. modulators.

And to present data from the phase wouldn't be portion of this trial and 2021.

With that I'll pass it over to Stephanie for an update on our financials.

Thank you to think that afternoon, I've airline detail financial results for the first quarter of 2020 weren't quite in today's press really Oh briefly review every cell phone call.

<unk> remains well capitalised cash cash equipment that investments were 138.1 million.

At March 21 2020.

They probably complete.

Public offering.

5.750 million share some common stock cannot perceive that approximately 33.59.

I believe our cash position enables us to drive clinical programs to meaningful value inflection point.

Alrighty expenses were 20.1, along the corridor March 31, 2020, compared to 20.2 million kinda same period prior year.

But decrease was primarily due to a 1.8 million decrease me on this date program and it decreases 0.8 million early stage research, partially offset by an increase of 1.4 million. That's all the finest that program and it increases their acquaint 5 million on a C.D.T.V. program.

You can expenses were 4.9 million kind of quarter March 31 2020.

Bad with 4.2 million for the same Paris prior year increase was primarily related to 0.5 million on higher professional services costs.

Point 2 million and a higher facilities costs.

Interest another income no 0.69 for the three months on that much 31, 2020 compared to 0.7 million cause same parent prior year.

That lots of good three months ended March 31, 2021, 24.4 million or 38 cents per so.

And the dog I when I was trying to call back over the season.

Thank you Stephanie I'm without operator breath details in the line for question.

Maybe this gentleman as a reminder to ask a question do we need to per store one thing your telephone keypad.

Answer withdraw your questions you can press the pound a hash key please stand by wild compiled a key when they roster.

Again that a star one.

We have our first question comes from <unk> <unk> Bansal.

Hi, guys is James on for about it.

On.

Code, giving you ask permission to smoke sure pipeline on call administration at all so are you see me any changes to your plans for manufacturing or marketing due to the pandemic.

You see my answer that question that off.

Hey, James Yeah, actually I'm, sorry, I didn't quite capture the very beginning catch the very beginning of the question about the <unk>.

<unk>.

Oh, just asking is over that you know given you ask permission to focus more of the pipeline on all administration products.

Well I wouldn't say that the you know the impacts having it orally administered you know having orally administered drugs in the in the context of covert has been.

Yeah, probably less disruptive than it would be for patients. If they were having to go in parentheses runs on a regular basis, you know whether that's changed our longer term sort of strategy around that I I think that's been our focus there has been early early administered drugs all along so it's certainly provide support for that approach and and you know is.

<unk> is helpful. In this context I'm not sure in the longer term you know it has you know a a longer term impact on our strategy, but then but you know in general that's our focus.

Anyway.

And then she had a question about manufacturing could you repeatedly hi.

Yeah. Just wondering if you know cover does change or you're thinking about what partnering for manufacturing or some of your strategies for marketing <unk>.

No.

He changes how you're thinking about those things.

I'm not at this time, we have no issues with arts acquired spurt, A.P.I. or drug product for <unk> inhibitor too. We're feeling good right now we of course always have strategy to increase our backup manufacturers both starting materials.

As well as H.T.I. as time goes on to if we get closer to commercialization, we do Clancy diversified where we manufacture and tried to start right now we have not yet experience any matrix a nice.

Got it.

So I could ask one more.

Yeah, but at certain states seem to be loosening, social <unk> been protocols.

Relatively different degrees is there a chance some of your studies the enrollment get started sooner than others.

Well so that's a good question I mean, I don't know on from a state by state perspective, you know changes that are happening in different localities and and just the differences you know impact and maybe the different approaches. The local areas are taking I would say sites are take.

<unk>.

Different approaches or are loosening up.

You know at different times again based on the low sort of the the local environment. So you know you could imagine maybe sites in New York or having a different approach then you know sites in an area, but just haven't seen much of the disease at all.

So having said that you know we as as we just said we are going to be able to we think open up our ongoing study. The the two Pfizer combinations were you know where we had pause enrollment because that's an already open study. That's you know we are hearing.

Sites that you know, we should be able to started rolling this quarter.

And that's a different proposition than opening a new study that requires you know <unk> review and so forth. So so we are you know looking to open those studies sooner and as we mentioned you know the two new studies that we expect that we're opening that the keepsakes study and our our phase.

Phase wouldn't be studying in C.S. patients both of those we plan to open in the third quarter, whether it's you know I I, so I and I. So I think those remain on tract. So that we are hearing signs I guess, what I was called signs of life from our from our sites. They're starting to now think about you know opening and enrolling and so that's allowed us to really.

Starts of planning processes for the for the next next steps in these studies.

Thanks, guys created.

Uh-huh.

Oh next question costs are online Jonathan chain.

Did you maybe you can quickly.

Hi team. This is John Barrett on for Jonathan just two questions for me back in back it has no when you present, a D.N. try the data.

I recall that the overall slip survival data was not yet mature what's just wondering if you had an update on whether or not that data is maturing if we could spend when or if we could see that data.

Yeah. So we don't have a a a an analysis of the of mature data at this point that as of the last analysis. It was not yet mature, but we wouldn't be expecting it to mature and when it does we will be presenting it either in the context of a manuscript or or.

<unk>, so it will be coming but at this point not not ready to be presented not not mature.

[noise] Gotcha and one question the keep one strategy of course, presenting some data and there's been a lot of publications on the solid rationale for testing a a blue termination inhibitor in this patient population, but just as an exercise in risk management.

Based on your data conversations with K. wells can you discuss any areas up concerns or thoughts on why group 10 minutes might not work in this population.

You know what I've I, what I would say is that the our investigators, including the preclinical investigators who kind of done the work and R. and R. clinical investigators are very enthusiastic about about studying glutaminase inhibition. I mean, we don't go into any study with 100 per cent certainty that you know of activity. That's why we're.

That's why we run the studies, but this one I would say, there's particular enthusiasm around based on both the strength of the pre clinical data.

They really strong just you know mechanistic rationale in addition to the actual data, but it just makes good sense based on understanding the biology and then finally, the you know they really.

Hi, unmet need in this population has become very clear you know.

Broadly throughout the the the lung cancer community. So so the main focus of of our discussions has been you know just around the enthusiasm for the data and and and then huge on that need and so so they're looking forward to getting this study started.

Great. Thank you so much.

And that's cushion costs on the line of Jim <unk>.

Hi, guys. Congrats on all the progress a couple of questions I guess, just sticking with the keepsake study propelled Glenn let us that could you talk about current standard of care for those patients.

With the mutation do they have a lower mutational burden or less amenable to P.D., one inhibition or maybe you could just talking about the standard of care and what you're looking to add to or improve upon.

Yeah sure. So so this population doesn't have a unique standard of cares for it. So these patients get what is effectively the the current standard of care for most patients will get chemo plus plus pembro in the front line setting although in you know it's also approved pembro.

Alone is approved and it was it the P.D.L. positive population. So either of them are approved therapies I would say that the chemo plus plus Pembro is you know what's being used generally.

In terms of their you know how they behave they certainly do poorly and that's been published multiple times now that this population does not do well, but it's a very poor prognostic factor. The exact you know mechanistic cause of that is not totally clear keep one.

Is not necessarily associated with being P.D.L., one low it's got a fairly standard distribution of P.L. one expression.

So that doesn't seem to be the driving force I think in terms of T.M.B. is not particularly out of the norm there either so so there's no there's no.

Clear rational from that perspective that might that might provide a clue I think it's you know the pre clinical data suggests that these patients are just much better at managing and a reactive oxygen stress that that these cancer cells generally have to manage and therefore, I'm more aggressive and and so there's there's nice preclinical.

<unk> to support that mechanistic reason for them being.

Poor prognostic and that's consistent with what we hear from investigators you know these they often will tell us when these patients walk in the door. You know you have you kind of know where you have a good sense of who they keep one meeting patients are going to be because they're diseases more aggressive. So there's there's clearly different biology, there it's not just about.

Response to therapy, but it's actually just about more aggressive diseases in overall bad Prognostics factor.

And so I you know recognizable get detail on the trial design. It at the ask a virtual meeting, but it is the idea that you'd.

<unk> to study do the randomized study in patients progressing on a P.D. one based therapy.

No. These these are frontline patients. So we're we're looking at first line patients who are have not received any prior therapy for met a static disease. So this will be there you know, they're they're first exposure to to to Pembroke plus chemo you know again standard front line therapy Board.

We're adding on top of it the the study is gonna be standard Pembroke chemo, plus or minus telephone us then.

God, Okay, and then maybe just one on C.B. 280, just on the 28 day.

Fine frame to try and you know assess you know benefit of of of the drug is that enough time to see a functional Bennett said on something like force vital capacity or F.T.V., One war would you'd be looking more at biomarkers to assess optimal dose.

Yeah, now we would expect to be able to C.F.T.V. one improvements in fact that will be the you know the primary endpoint of the 28 days you know phase two portion of the study.

The F.C.D. one <unk>, we we have I mean, certainly from the see a P.R. modulator perspective, you know improvements in S.T.V., one happen relatively quickly and and even impatient to receive yeah they've been.

Of concept studies done in patients treating them with Argentine whether it's you know I v. or inhaled and improvements have been seen there as well in F.T.V., one and they've happened within two weeks. So you know our expectation is that certainly in four weeks and even within two weeks, we may be able to start seeing F.T.V. one improvements.

Oh, great. Thanks for taking the questions.

Thanks, Jim.

<unk>.

Next question comes from a line of out there he.

Hey, guys six what to keep my question <unk>. So I have quite during a question regarding on that keepsake.

Trial for the interim wait out so what kind of data say that we could expect it for that.

Yeah. So <unk> you know we're looking at so we're be focused on p., a fast as as the as the endpoint and as we mentioned the studies about 120 patients. So we will be looking for at a subset of that probably you know half for a little less than half of the patients having you know relatively mature data that the.

Data for the for these patients will because of this short P.F.S. expected you know for the M.D. Anderson data set the peer fences around 2.8 months the medium give us for this population you know we will expected to be a little longer than that but we would expect the medium confessed to be relatively short. Unfortunately.

For these patients so we expect to be able to get a relatively.

You know good look at P. It fast from that first you know 50 to 60 patients.

Thank you very much for the color and the maybe just to follow up on that part is there any <unk> stretched flight according to to keep long enough to mutation or other <unk> other criteria patients.

Yeah. So there will be stratification factors in the study, we're focusing mostly on the stick 11, <unk> also called L.K.B. One. So this is in another highly prognostic mutation similar to keep one in terms of its prognostics significance and so in order to <unk>. So.

It's an important factor that we'd like to balance between the arms. So it'll be stratified by mutation too just stick 11, as well as to the yeah, M., one a. versus them when B.C. status, so essentially they're they're staging criteria and there will be which is again.

Prognostic and so we we want to get these.

Shortened prognostic variables to be well balance between the arms.

I see Oh six for that cutter.

Yeah.

I was last question comes from a line of met tip.

Alright, Thanks are getting in there so I.D.C. or isn't had a nice presentation looking at this pathway. The the keep on their t. exactly and they you know showed the combo two critical all trial with with the into her heathers.

The Kid is going to have some data ASKO looking at their <unk>. This patient population, obviously focus do you guys I'm getting to get to the chemo combo started off but you know are you seriously considering.

Some other commas in these patients now or would would you wait and see some of the internal data before kind of branching into additional drop in the city.

So so the the combination with the torque one too inhibitors are you know are very interesting to us there or you know very nice preclinical data we've been working with in group Yeah academic group that has that and in fact, there is a.

Study, that's that's planned and actually yeah in the process of opening that's combining telling us that with.

One two inhibitors. So so that's something we are very interested in Mechanistically. We think the rationale is very strong. We generally agree with you know the the the data that had been presented by my Epson I think they've done a nice really nice job of sort of validating the than the work.

We've done in the biology that that we you know that were that we've been talking about so so were you know we think that was a great presentation at H.T.R. and we certainly support in are interested in this you know combination with towards one too.

Escape and then so let me 58.

A small last year you guys.

Disclose that the Simon stage to head that reach for both colorectal. What you showed some data for but also had a neck <unk> the others, we're all still stage one or.

Can't say at this point, but at any other indications moved onto stage too.

You know do you think we'd get an update on the next six months or the more next 12 months.

Yeah, we're not at Liberty to to to talk about the you know the other the other cohorts, but you're right. The they had an act one had moved from stage one of the stage to and you know and and we will you know we can't really guide right now and and when will be able to present that that's as as you know will be a discussion between.

Ourselves and and insight in that kind of a joint joint decision around the right time, we we do like to wait for these codes to be mature. So we have a good feel for things like the response raid the and the durability of those responses and a and even the P.F.S. in these in these groups. So so at this point, though.

You know no guidance on that but.

But but you're right at a neck, you know has reached stage two and and the others are aren't going.

Okay. One last question. So check me money are obviously just write out positive.

And you know assumptions are cabometyx will be able to gain more attraction in the front lines setting.

Obviously, we see the results of the compared to trial, but.

Do you envision that a physician would be hesitant to provide a cabo competing regimen for a patient and maybe yeah, we laughed.

<unk>.

One thing.

Yeah. So we I mean, we've we've as we've talked about this in the past in the sense that we were fully expecting the study of you'd be positive that you know there was no reason to think that they wouldn't have a positive study here, obviously that frontline space is fairly yeah fair fairly competitive <unk>.

Unaided amongst the number of regimens that are including I. or therapies. Several of which are these two of which I think are pretty well entrenched at this point you know <unk> I I would agree I think it's.

I think it's an open question, but we would agree that patients coming off of Cabo in the front line would be less likely to come onto a cabo containing <unk> in in the second line I'm, having said that you know we again, we think that's in the majority probably the large majority of patients will you know will come off of front line I'm not.

Being seen combo in so we still think second line as being a great place for for Carbo cover to be used in for a cabo combination to be.

You know to be approved in.

Having said that the you know we have the potential to to look at other you know 'cause central look at other other combinations other T.K. eyes or even look at front line down the road. So there's other places we could go with <unk>.

But I you know, we're pretty confident that the second line space remains a very very good place for for a couple of combination.

You're right that's good for sure.

Yeah. They spent.

Yeah, no more questions on the phone line all the time they'll call over this you know from it anyway.

Thank you to stay in thank you all quite Chinese yeah, Oh half a great evening.

Hi, This gentleman <unk> conference call. Thank you all for participating.

Connect.

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