Q4 2020 Calithera Biosciences Inc Earnings Call

Ladies and gentlemen, thank you for standing by and welcome to the Cowboys Dara Biosciences fourth quarter 'twenty 'twenty earnings Conference call.

This time, all participants on a listen only mode. After the speaker's presentation. There will be a question and answer session. That's a good question. There on the session you will need to press star one on your telephone if you require any further assistance. Please press star zero I would now like to hand, the conference Steve Speaker today, Jennifer Mcneilly V P.

The Investor Relations. Please go ahead ma'am.

Thank you Joelle good afternoon, everyone welcome to our year end 2020 conference call. Joining me today are Susan Molineaux, our founder President and CEO.

Keith Orford, Chief Medical Officer, and Stephanie Wong Chief Financial Officer.

We have issued our press release from it can be accessed through our website at <unk> Dot com.

Before we begin I would like to remind you that today's discussion will include statements about our future expectations plans and prospects that constitute forward looking statements.

For purposes of the Safe Harbor provision under the private Securities Litigation Reform Act on 1995 actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those in the risk factors discussed in the risk factors section of our quarterly report report on form 10-Q filed with the FCC.

In addition, any forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent day, while we may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views change. Please note. This call is being recorded.

And with that I'll turn the call over to Susan.

Thank you Jennifer good afternoon, everyone and thank you for joining us today on our fourth quarter and year end 2020 conference call.

On behalf of the entire team I'd like to say, we hope that you're on your friends and families for name healthy.

'twenty 'twenty was a challenging year.

For the newly everybody as we face new challenges from public count. Despite the challenges we faced we are quite hopeful for the future.

At calendar year 2020, with your execution, we successfully completed and reported results of our global randomized trial in renal cell carcinoma early in 2021 while advancing our pipeline of novel Therapeutics.

We want to thank all of our employees have done an extraordinary job of maintaining a high level of professionalism productivity and dedication at work, particularly towards helping us achieve our goal of reporting top line results of the cantata trial in January.

Both are appreciative and proud of our entire team for accomplishing a number of challenging goal.

And while you're disappointed in the results of the cantata trial, we remain enthusiastic for the potential of contaminates inhibition to be a novel approach to the treatment of cancer and we remain committed to our mission of being an integrated biotechnology company that develops novel small molecule on co metabolism drugs drugs that are <unk>.

Getting tumor and immune cell metabolism pathways for the treatment of cancer and other diseases.

By building a pipeline of novel therapeutic product candidates, we are creating multiple opportunities to positively impact clinical outcomes for patients and drive opening programs towards commercialization.

We are continuing to develop telecom on a stat and we are enrolling the randomized keepsake trial in first line non small cell lung cancer patients harboring genetic mutations and keep on nerf too.

We also continue to evaluate telephone on a stat in multiple indications, including investigator sponsored trial.

Our partnered Arginase inhibitor program is ongoing looking type, where we have a number of clinical trials evaluating C. B 11, 58 for the treatment of cancer.

While we remain committed to and confident in the 11 58 development program, we have decided to opt out of our co development obligations. At this time effective September 32020 as permitted under the terms of the inside agreement in order to focus our resources on our own internal development programs as a result of that.

Our decision to opt out insight will pay all costs to develop a 11 58.

Arginase inhibitors also have potential in the treatment of cystic fibrosis and accordingly, we selected C. B to H E. A unique oral arginase inhibitor for the treatment of this patient population in November 2020, we announced that we were awarded up to $2 $4 million from the cystic fibrosis Foundation to support clinical.

Development of T V. Two ready and we are grateful to the cystic fibrosis foundation for their support and we're pleased to be working with them.

We have a broad pipeline and a productive R&D team and we remain focused on producing novel drug candidates with the potential to be highly differentiated new therapies in areas of unmet need.

And with that I will pass the call over to Keith for additional details on our clinical program.

Thank you Susan.

Begin with a more detailed update on telecom on a stat argued termination inhibitor in development for the treatment of first line lung cancer and patients with keep on Nerf KIR mutations mutations and to keep on nerf, two pathway, which occur in an estimated 20% of non small cell lung cancer patients are associated with aggressive disease numerous.

Recent reports of clinical data have demonstrated that activation of this pathway either sugar loss of keep one function or activation of nerf too are associated with poor clinical outcomes among patients with non small cell lung cancer, receiving frontline standard of care therapies, including chemotherapy immunotherapy and chemo immunotherapy.

Preclinical models have shown that activation of the keep one nerve two pathway makes tumors dependent on contamination activity for growth and survival, making these tumors exquisitely sensitive to inhibition of <unk> activity by <unk>.

The double blind totally on a stat trial known as keeps day.

Enrolled the first patient in September 2020, and will enroll approximately 120 patients.

Eligible patients are newly diagnosed with stage four non squamous non small cell lung cancer with tumors that have to keep one or <unk> two mutation.

Patients will be randomized to receive telephone us out or placebo in combination with timber Elizabeth Carboplatin and Pemetrexed.

The study will evaluate the safety and invest investigator assess PFS.

Tokyo on our staff plus the standard of care chemo immunotherapy regimen.

We plan to share interim data from this trial in the second half of 2021.

We are also conducting exploratory phase <unk> trial in collaboration with Pfizer, combining told them on staff with eyebrows.

In 2020, we announced the initiation of the first clinical trial to evaluate our novel Arginase inhibitor in cystic fibrosis, and we are pleased with enrollment to date.

The depletion of arginine in cystic fibrosis patients by the enzyme arginase.

Results in reduced production of nitric oxide Ah Kee antimicrobial and bronchodilator.

Therefore, our arginase inhibitors have potential in the treatment of cystic fibrosis, and we have selected CB 280, a unique oral arginase inhibitor. So we own by Cal therapy for the treatment of cystic fibrosis.

In October 2020, we presented a trial in progress poster describing the trial design at the North American cystic fibrosis conference the <unk>.

Presentation included preclinical study results, which suggests CB 280 significantly improved lung function and reduce pseudomonas Pseudomonas aeruginosa colony, forming units and preclinical models.

Arginase inhibition with CB 280 resulted in improved central airway resistance and see FTR knockout mice and decreased lung infection, and wildfire and Delta five F. Five O eight CFT are expressing mice infected with Pseudomonas aeruginosa.

We plan to share data from this trial in the second half of 2021.

We've also identified CB 668.

An investigational first in class potent orally administered IL four IL, one inhibitor as a novel immuno oncology approach to cancer.

GBP 668 is an inhibitor of the enzyme IL four I won an enzyme that is expressed by tumor cells and antigen presenting cells metabolize phenylalanine tyrosine and tryptophan to produce hydrogen peroxide inhibitor of T cell function.

I hope for I, one expression has been correlated with poor outcomes in several tumor types has the potential role in immune evasion and may decrease the ability of checkpoint therapy to stimulate an anti tumor immune response I hope for I. One expression is elevated in multiple tumor types with particularly high expression in ovarian and b cell tumors.

New preclinical data for <unk> 668 was presented in November 2020 at the society for immunotherapy of cancer virtual meeting.

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

Thank you Keith and good afternoon, everyone detailed financial results for the fourth quarter and year ended 2020 were included in today's press release I will briefly review our results on this call.

<unk> remains well capitalized our cash cash equivalents on investments were $115 2 million at December 31, 2020, which we believe will be sufficient to meet our current operating plan through 2022 R&D.

R&D expenses were $71 million in 2020 compared to $76 3 million in 2019. The decrease was due to a $6 2 million decrease from the 11 58 program and a $3 8 million decrease in early stage research, partially offset by an increase of $2 7 million in the telecom Glen a step program and in it.

Increase of 2.0, a million and a CB 280 program R&D expenses for the fourth quarter of 2020 was $17 1 million compared to $17 9 million for the same period last year.

G&A expenses were $20 4 million in 2020 compared to $16 6 million in 2019. The increase was primarily related to a $2 5 million increase in personnel related and facility costs and on one $3 million increase in professional services G&A expenses for the fourth quarter of 2020 were $5 6 million.

As compared to $4 6 million for the same period last year.

Interest and other income net was $1 3 million in 2020 compared with.

$3 million in 2019 interest and other income net for the fourth quarter of 2020 was 0.1 million compared to 0.7 million for the fourth quarter of 2019.

Net loss for the quarter on December 31, 2020 was $22 6 million.

And with that I will now return the call back over to Susan.

Thank you, Stephanie and with that Joelle, we're happy to open the lines for cash.

For questions.

Thank you as a reminder to ask a question you will need to press star one on your telephone.

Joe Your question pets per pound key please standby, while we compile the Q&A roster are free.

First question comes from Mohit Bansal with Citi. Your line is now open.

Hey, Good afternoon, guys. This is James on from Mohit. Thanks.

Thanks for the update on taking the question.

First question.

Any color on the enrollment target for Keepsake I know we are on track for data later this year, but can you.

Give us a little bit of numbers.

At this point or is that still sort of.

Work in progress and then related to keep sake.

There were some recently from data from the Trs neighbor, showing that stick 11 mutation patients had a higher response to the <unk> inhibitor and I know that you guys had previously mentioned that to keep the trial will have a good proportion of 11 patients. So I was wondering if <unk> looked at combining.

With any tariffs on a per <unk>.

Yeah, Hi, James This is Keith in terms of enrollment so as we said were planning to.

Enroll in them.

You know make public some data from the initial interim analysis later this year.

I think enrollment has been I would say impacted by Covid I think that I think all if you probably asked anyone there has been some impact from COVID-19, but it's something we're working through and we remain confident in our timeline to be able to get to that too.

Data on that interim analysis later this year, so definitely some impact but something that we are working through.

Terms of the Kers story, it's definitely one we're quite interested in.

And that's sort of a I guess I would say a work in progress something we're looking into on our side.

But an area of a lot of interest.

There's been a couple of different reports on the impact of of stick 11 that actually between the two clinical care Ras inhibitors that were somewhat different so that'll be interesting to see how that plays out but that's definitely remains a combination of interest.

I appreciate it guys. Thank you so much.

Mhm.

Thank you. Our next question comes from Matt Phipps with William Blair. Your line is now open.

Thanks for taking my question.

I guess, just kind of a follow up on that in term I mean, this will be an interim for PFS I assume right as opposed to maybe just response rates.

Are you still thinking.

PFS in the control arm of around seven months or has there been any day to lately.

<unk> that assumption.

So yes in terms of Hey, Matt.

In terms of the assumptions, we've actually been for this population. So so far the keep one mutant population the data that had been reported in our feed from places put that probably the median somewhere in the three to five month range.

So this isn't frontline so these patients do very poorly.

And so that's that's what we're assuming.

And yeah in terms of the data that we would be.

Talking about.

It's probably a combination of PFS as well as response rates.

The data will be you know.

It's going to be an interim analysis from the data, we will still be kind of maturing.

So we're not going to be talking about fully mature data, but we do but given the short.

On the short expected PFS median PFS for the control arm.

Would you expect to hopefully see some mix.

See some daylight between the two curves and be able to see a trend in the right direction there.

Excuse me on any chance, we see a update from that eyebrows combo.

And thank you added this year.

We haven't guided on that I think it's.

It's a little hard to say exactly when it'll it'll likely be this euronext, but.

Study really just started enrolling so.

I think it's too early to say with certainty.

Okay.

Yes. Thank you.

Thank you. Our next question comes from Jonathan Chang with SBB Leerink. Your line is now open.

Hi, guys. Thanks for taking my questions.

First question can you provide your latest thoughts on how much on how mature the second half.

Interim data set for keeps they could be.

Yeah, Hey, Jonathan Yes.

In terms of the.

We're expecting somewhere in the range of 40 to 50 patients worth of data.

By the end of the year.

And I think that's that's kind of the ballpark.

As we've talked about before the analysis is not.

On explicitly defined in the protocol with.

And.

Having a specific sort of.

Statistically driven and.

Endpoint or analysis, it's not a futility analysis.

And early efficacy analysis, it's an administrative.

Interim that allows us to have an early look at the data and react as appropriate which could mean any number of things reaching out to regulators starting to prepare for a subsequent study.

So that's the kind of the spirit of the of the interim.

And in terms of maturity.

I guess I would say, obviously patients who were enrolled later.

As we get closer to the interim analysis, the those patients will be more likely to be to be censored and have less mature.

Data the hope is to have.

Hopefully a couple of scans for those patients.

So that we can get a feel for the medium PFS as we talked about the median.

Is in the range of three to five months.

For the control arm, we would expect so yes, if we can start to see separation net debt then.

Early time point that would be.

Encouraging.

Got it thank you.

And last question, how are you thinking about potential business development opportunities for your pipeline.

Okay.

Well this is Susan Hi, Jonathan.

In general we remain open to.

Two partnering opportunity as one of simple ways to continue to develop our pipeline.

We will read out this year the first data in cystic fibrosis patients.

And we have a clear picture of where we might go next if that day.

Looking courage, Inc.

And there might be a partnering.

Partnering opportunity somewhere along the cystic fibrosis development timeline and as you know we do have earlier stage.

Pipeline.

Net that our A&D ready, we have a CB 73 small molecule oral inhibitor and we also have an inhibitor for IL for icon.

And.

Partnering is the possibility for those as well and for telecoms that we'll wait and see what develops but we're always open to partnering at the right time point it might be.

Got it thanks for taking my questions.

Thank you. Our next question comes from Arthur He with H C. Wainwright. Your line is now open.

Hey, good afternoon, everyone. Thanks for taking my question.

So I have two.

So regarding the keeps the six study.

I missed.

Give us some color on the regarding enrollment.

And second.

Regarding the phase one two study of pedigree on income.

In brands.

Could we expect expect any data update at <unk>.

Yes.

Yes, Hi, Arthur.

In terms of enrolment for keepsake.

Well, we don't usually give sort of specific.

<unk> of patients enrolled I did mentioned that there is there has been some impact from Covid I think there is it's probably multifactorial both at the level of the sites.

Who have.

On staff.

Impacted in various ways as well as patients since this is a frontline study.

Okay.

Patients.

Getting diagnosed.

In the frontline setting.

Is it necessary for patients to be enrolled from the study.

I think theres there are ways in which COVID-19 is impacting clinical studies.

Where we are.

Like everyone else experiencing that.

But as I mentioned, we still remain on track everything for per data by the end of the year.

On the and then in terms of the <unk>.

Study.

First study is enrolling.

Enrolling and we're monitoring the day there have no real update there from.

From an enrollment perspective, I think we talked about data probably.

Either this year or next with that with that study, but hard to be more specific on that at this point.

Thank you. Thank you for taking my question.

Thank you.

Thank you. Our next question comes from Matt Phipps with William Blair. Your line is now open.

Hey come back on thanks, Keith.

Wondering if we could talk just walk through some.

Hypothetical next steps after this interim so.

You know obviously you will present the data.

Depending on the level of activity, but is it okay. Maybe we go take it to the FDA or is it. Okay. We're just going to continue to let the trial run out or is there a does the trial, having some kind of built an adaptation to expand enrollment so maybe make it pivotal if things are looking good just curious.

What kind of.

Potential next steps after this interim look.

Yeah. So so.

So it's a great question and those are the kinds of things we're thinking about it for example.

We can always reach out to FDA with the data if they are compelling.

For example talk about breakthrough designation talk about them.

Either amending the current study.

Or.

Starting the planning for a subsequent pay.

Pivotal phase III.

So those are the kinds of things that by looking early we can kind of get a start on what we think that the.

On the best path path is and again all of those are really options.

Probably.

<unk>.

With FDA would be.

Part of that if we were looking to move forward.

With an accelerated path to.

To approval in some way.

Do you imagine the.

Trying to restart from the FDA would occur before moving.

On the day to give them.

Correct submission timelines.

So I would say FDA interaction with the FDA is independent of any kind of presentation.

At a meeting and so I wouldn't link those to each other.

And frankly, what we're talking about isn't necessarily even.

Yeah.

Good.

I think what we've talked about it in the past is that this may or may not be an actual.

Conference presentation. So.

Or maybe a prelude to a conference presentation. So.

The discussion this year wouldn't it wouldn't necessarily be in the context of a of a conference.

Got it okay. Thanks Keith.

Thanks Pam.

Thank you I'm not showing any further questions.

And our next question comes from Nick Abbott with Wells Fargo. Your line is now open.

Good afternoon. Thanks for taking my question and apologies I missed nearly all of the prepaid remarks thing on Cornwall to question on the <unk>.

NCI study is coming on on statin.

So on.

I know you may not have a lot of insight into that trial.

Weighted end of Jan you need to still talking about having data in June. So do you have any insight into that role.

Is this a way also to help.

Derisk keepsake and from a weak patients.

You also have to keep on mutation.

Yes, so actually.

As we've as we talk about oftentimes.

Hi, Nick by the way.

We don't have any any real insight at this point that we can share on on this study.

So I think it's an interesting question.

Whether it's about keep keep mutant patients or just looking at the combination with Teekay is targeting driver mutations I think it's an interesting study.

We look forward to learning more about it but at this point.

It's not something that where we're able to to speak to you.

Okay.

And then just.

While I know there's been a few questions on on the brands on combination me can you remind us when the colorectal and non small cell lung cohorts from Nathan.

Mutations in <unk>.

And is that the day to you're referring to as possibly being vulnerable won't be end of this year will be mixed.

So that's a good question you're testing my memory of when the study opened that I'm not sure I'm going to be able to answer that accurately without looking it up so so I apologize I can say the pancreatic.

We added cohort opened more recently so that was one that we added to the study by amendment.

So that was I think opened late last year.

But the timing of the colorectal data alright, the colorectal and lung cohorts.

Opening I don't know if I can answer that for you.

As we sit here I will say, though that the data that we could present, where it could be those data and the pancreatic data from any or all of those cohorts as possible.

But we will get back to you on that on the timing of that.

Matt.

Let's start on this.

Certainly apologize I'm sure sure I should have that and Grand on my head somewhere from.

Yeah.

Thank you I'm not showing any further questions at this time I would now like to turn the call back over to Jennifer Mcneeley for closing remarks.

Thank you Joelle and thanks, all for joining us today have a great evening.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

Okay.

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Moving on.

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