Q2 2020 Calithera Biosciences Inc Earnings Call
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Ladies and gentlemen, thank you for standing by and welcome to the catalyst there second quarter earnings call. At this time all participants are in listen only mode. After the presentation. There will be a question and answer session to ask a question. During this session. Please press star one of your telephone if you require any further assistance. Please press star Zero Oh now she had a conference over the years.
Speaker Jennifer Mcnealey. Please go ahead.
Thank you Stephanie good afternoon, everyone welcome to our second quarter 2020 conference call joining me today or excuse and on our founder President <unk> CEO, Keith Orford, Chief Medical Officer, and Stephanie long SVP of Finance, we've issued a press release and it can be accessed through our website at <unk> dot.
Tom.
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 provisions under the private Securities Litigation Reform Act at 1995 [noise].
Actual results may differ materially from those indicated by these forward looking statements as a result at various important factors, including those in the risk factors discussed in the risk factor section of our quarterly 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 real applied upon as representing our views as of any subsequent date.
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 changed. Please note that this call is being recorded and with that I'll turn the call over to Susan.
Thanks, Jennifer and good afternoon, everyone. Thank you for joining us today on our second quarter Twentytwenty conference call on behalf of the entire team I'd like to say, we hope that you in your family's remain healthy while the world's addresses the challenges of the cobot 19 pandemic.
For a number of months working from home, we can say that we have transitioned smoothly to the new work environment and are prepared to maintain this work schedule into the coming months.
At the same time, we have reopened our labs and have been able to maintain a safe environment to those workers, who have returned to the office.
We want to thank all of our employees, who have done an extraordinary job of maintaining a high level of professionalism productivity and dedication network, while balancing it with all the personal challenges that coven 19 brings we're both appreciative and proud as our entire team.
We continued our positive momentum from 2019 into the first half the twentytwenty further strengthening our cash position and advancing our key clinical development program.
At Calithera, we are building an integrated biotechnology company that develop novel small molecule oncomed metabolism drug.
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 product candidates, we're creating multiple opportunity to positively impact clinical outcomes for patients and drive development programs towards commercialization.
We are the first company they take a selective contaminates inhibitor into the clinic and the first to demonstrate clinical activity in cancer patients, including proof of concept for the activity of pellicle NSF in renal cell carcinoma in our randomized trial the trial.
On top of trial with registration potential in renal cell carcinoma patients is fully enrolled with topline data expected late fourth quarter Twentytwenty for early first quarter 2021.
It's moves us a step closer to becoming a commercial biotechnology company and we are focused on laying out the infrastructure unplanned neither for a successful future.
We are developing tell Glenn if that broadly and have continued progress towards initiating a randomized trial <unk> first line non small cell lung cancer patients harboring genetic mutations and keep one when those two.
Study sites are now opened for enrollment in the keepsake trial, and we expect to be enrolling patients near term.
Our apartment for Argentina, we have it or program is ongoing within sight, where we have a number of clinical trial evaluating seal up 58 for the treatment of campus.
Our kinase inhibitors also have potential into treatment of cystic fibrosis.
Accordingly, we selected TV to 80, a unique oral arguments inhibitor for the treatment of this patient population and.
And in this quarter. We are pleased to report that we have advanced our argenis inhibitors TV to 80 into a phase one be clinical study in cystic fibrosis patients.
We have a broad pipeline and a productive R&D team, we remain focused on producing novel drug candidates with the potential to be highly differentiated new therapy in areas of unmet.
With that level across the call over the key for additional details on our clinical program.
Thank you Susan let's begin with a more detailed update on told when Scott.
Termination inhibitor and our most advanced product candidate.
We're currently focused on forging a clinical and potentially commercial path for told when is that in renal cell carcinoma.
In October 2019, we announced completion of enrollment.
On a global randomized double blind trial in Calvin Stat.
Combination would cover Janssen in second and third line RCC patients and try to enroll 444 patients had a schedule demonstrating the significant unmet need for advanced RCC patients in the second and third line setting.
Content is designed to evaluate the efficacy and safety told when is that in combination with cabozantinib versus placebo. So it's Kevin again.
And clear cell RCC patients, who had previously received one or two prior lines of therapy, including at least one prior and eugenic agent worthy Illumina volume at combination.
Patients randomized one to win ratio to either Kelvin if that was cabozantinib or placebo plus Kevin.
Patients for Stratifying by NGC risk category and prior treatment anti PD, one PDL one therapies.
The primary endpoint has progressed progression free survival by independent review.
Overall survival of use as a key secondary endpoint.
Sorry endpoint is.
PFS.
In light of delays associated with Kogan, 19, and pending further developments any ongoing pandemic.
We expect to report topline data in late fourth quarter were really first quarter 2021.
We also believe told Monistat has the potential to be developed in patients with keep one or two indications.
Occasions, you keep one or two pathway, which occur in an estimated 20% of non small cell lung cancer patients.
Our associated with aggressive tumor growth.
Recently presented clinical data demonstrate that activation of this pathway either through the loss of keep one function for activation of nurse to our associated with poor clinical outcomes among patients with non small cell lung cancer proceedings frontline standard of care chemo immunotherapy.
Preclinical models have shown that activation of the Keith one or two pathway makes tumors dependent on contaminates activity for growth in survival, making these tumors exquisitely sensitive to inhibition and good chamonix activity I told when is that.
The double blind told us that trial known as Keepsake is open for enrollment and will enroll approximately 120 patients.
Eligible patients will be newly diagnosed with stage for non squamous non small cell lung cancer with tumors that have the keeps on ordinary nerve to mutation.
Patients will be randomized to receive told monistat or placebo in combination with Pembrolizumab Carboplatin and Pemetrexed said.
The study will evaluate the safety and investigator assessed PFS.
On a stat plus the standard of care chemotherapy regimen.
Given the previously reported challenges associated with opening new clinical studies during the current stage at the Koby 19 pandemic, we expect to enroll the first patients in this quarter ending further developments in recovered nicely situation. We plan to present interim data from this trial in 2021.
In addition, and Npis sponsored trial evaluating single agent hold on a stat in patients with solid tumors that had mutations in the key nerve pathway is currently ongoing.
The study will evaluate patients would keep one winner communications as well as other indications, including Nfone. Okay. Okay. You won.
We're also conducting two exploratory phase one being two trials.
In collaboration with Pfizer, combining telotristat, Mattel's, Ana and with hybrids.
In March 2019, we initiated a phase one two trial and the combination of top one is that hotels and <unk> in patients with solid tumors, including expansion cohorts in RCC and triple negative breast cancer.
Dose escalation has been successfully completed.
Following preliminary doses expansion, we are no longer developing this combination.
In July 2019, we initiated a phase one two trial of the combination of Telefonica step aside brands.
Patients for solid tumors, including expansion cohorts and KRS mutated colorectal cancer, and kras mutated non small cell lung cancer.
Dose escalation has been completed and dose expansion cohorts are once again enrolling following a temporary pause due to the cobot 19 situation.
We recently announced initiation of the first clinical trial to evaluate our novel Arginase inhibitor in cystic fibrosis.
Please note our gene in cystic fibrosis patients by the end margin Ace result in reduced production of nitric oxide, a key antimicrobial and Bronco dilator.
Therefore revenues inhibitors have potential in the treatment of cystic fibrosis, and we have selected it's easy to 80, a unique oral argenis inhibitor for the treatment of cystic fibrosis.
It is a novel Argenis inhibitor, which is solely owned by count there.
We completed a phase one single ascending dose trial to evaluate the safety Tolerability and pharmacokinetic profile of oral TV to 80 in healthy volunteers.
In July 2020, we initiated a phase one clinical trial in adult patients with cystic fibrosis in chronic airway infection.
The randomized double blind placebo controlled dose escalation trial will evaluate multiple ascending doses of CPQ 80, dosed orally twice daily for 14 days compared to placebo in up to 32 adults CF patients to determine a safe dose range for CBT rating.
We're pleased with the enrollment to date, given the challenging and unpredictable effects of program.
Our partnered Rgs negative program is I NCB zero zero about 58.
It is an investigational first in class immuno oncology metabolic checkpoint inhibitor targeting originates in immuno suppressive enzyme secreted by myeloid derived suppressor cells or NDS fees to block T cell activation in tumors Levaquin is being developed insight in a co development co commercialization collaboration.
58 is being evaluated as monotherapy as well as in combination with pembrolizumab across a cohorts of patients with different types of metastatic for locally advanced cancers, not amenable to local therapy.
Enrollment is now complete in the trial with monotherapy anti PD, one combination cohorts and the continued continue to evaluate can follow patients enrolled in these cohorts.
Second ongoing clinical trial is evaluating them 50 in combination with Threed chemotherapy regimens FOLFOX chip side of things as flatten or paclitaxel in patients with ovarian endometrial colorectal gastroesophageal and bill or any tracked cancers.
In addition on trial in multiple myeloma patients treated patients with 11 58 poster tumor ordinary to map alone is also ongoing.
We're pleased with the overall progress of the Lymphoseek program and we look forward to additional data updates from the 11, if the program.
In the future.
With that I'll pass it over to Stephanie for an update on our financials.
Thank you Keith and good afternoon, everyone keeps all financial results for the second quarter 2020 were included in today's press release, who will briefly review our results on this call.
Oh sure remains well capitalized or cash cash equivalents and investments worth 154.1 million at June 30, 2020.
In April we completed a public offering on 5 million Southern Hills in 50000 shares of common stock for net proceeds of approximately 43.5 million.
Labour cost position enables us to drive preclinical programs to meaningful value inflection point.
R&D expenses were 15.7 million for the quarter ended June Thirtyth 2020, compared to 20.9 million for the same period. Prior year. The decrease was due to a 2.4 million decrease telegraph that building a 1.9 million dollar decrease needing to be oil women Fivea program and a 1.2 million.
Decrease in investments in early stage, we see each person.
Offset by zero point $2 million increased 80 to 80 per month.
<unk> expenses were 5.1 million for the quarter ended June Thirtyth 2020, compared with 4.0 million for the same period coming here.
Chris was related to your point $9 million increase higher personnel related facility costs, and <unk> point 2 million in higher professional services.
Interest and other income was 0.493 months ended June 30, 2020, compared to 0.8 million for the same Harry pioneer.
Net loss for the three months ended June Thirtyth 2020 was 20 point Fourmillion with 25 29 cents per share.
And with that I will now be turn the call Dunkin' receivables.
Thank you Stephanie and with that operator, we're happy to open the line for question.
Certainly ladies and gentlemen, if you have a question at this time. Please press the star in the number one key on your telephone to withdraw your question. Please press the pound.
First question comes from Jonathan Chang would actually be Leerink. Your line is open.
Hi, Thanks for taking my questions.
First question can you provide any more color on light shifts.
Sure to protect us cantata data readout timeline, I guess, what specifically has changed from the lake guidance or for Q.
Yes, so while we are making steady steady progress toward bringing in the data and reporting topline results on there have been some kobin relating type kogan related timing delays and bring in their results and various geographies.
So what we've taken steps to mitigate the impact of CODI undertakes no not fully in Arkansas and so there is some potential for delayed beyond December and Thats why weve made that.
That slight shift.
That said, we're confident in the rate of progress, we're making and looking forward to presenting the data either late this this quarter or early next quarter.
Got it sounds like it's more about data collection.
Copenhagen impact is that correct, especially given the completion of enrollment last year, Okay, Yes, Thats right Jonathan Yeah exactly.
Got it.
Second question.
Can you discuss the returns for discontinuing the telegraphed that part combination.
Also are there any plans to present these data in the future.
Yes, so the PARP inhibitor combination was discontinued.
Continued on the basis of enough.
On a predefined efficacy.
Efficacy threshold that wasn't Matt and full dose of the of the combination drug <unk>, we're well tolerated so.
There was no safety or tolerability issues.
But we did set a you know a robust efficacy threshold that wasn't it.
Got it thanks for taking the questions.
Yes. Thank you.
Thank you and our next question comes more from Mohit Bansal with Citi. Your line is open.
Okay. Thanks for taking my question.
So.
Just wanted to build little bit more on the Bob drive combination discontinuation.
So just trying to guide going understand this for other combinations you have testing. So why did you bought they do that he tried.
Going into stores expectation phase.
You to move forward on Mcmil far to make that decision what exactly are you looking at.
Can you just stuff you can be bought about debt.
On the CDK point of view and sell because that would probably be coming soon.
Yeah, Hi, Hi, Mike.
So.
The.
Bars that article written into protocols are based on standard efficacy outcomes and they tend to be either response rate war or clinical benefit rate and we and we try to look at you know what we think guard first of all better than the expectations for the combination therapy and.
In this case PARP inhibitors.
Don't have significant activity.
In a in the indications of interest at least in the particularly with RCC.
And and you.
So that's it that's what drives it as well as whats clinically relevant so we're trying to both be kind of historical background as well as.
Achieve something that would be meaningful quickly and it's usually for these.
Type of single arm studies, either response rate or you know in some cases clinical benefit rain.
Got it has been thank you very much youth.
Thank you.
Thank you next question comes from that fits with William Blair. Your line is open.
Hi, Thanks for taking my question.
Can you just explain is there a set criteria for the interim analysis and keep six study.
Is there any.
The SMB provide a futility analysis, either as a just a certain number of patients reaching a you know getting scans and I guess duration of response.
Yes, so so there.
While there is a you know a.
Hey monitoring committee there the interim itself is not a like a you know where an efficacy or futility analysis per se in the sense of meeting a bar, it's going to be run at a certain number of patients.
And provides an interim look at the data and gives us the opportunity to to respond.
Potentially engage.
Or kick off additional activities on the on them.
The basis of those data.
But greg's Keith and I.
You touched on that you guys have started to be a little flexible and allowing local center a C.T. scan to collect all those data is there any risk and just kind of variability of a the city scan. If one was conducted it looks are conducted a different centers is there any way to account for that kind of variability.
You know withdrawal.
Yes, that's a good question, Matt and I think.
If we go back historically, there was more risk of that when CTG scanners have more variability in terms of the quality, but there are specifications that we require in terms of how the cici scans are performed.
In terms of the.
Thickness of the slices that are done and so forth that helps to minimize those those risks.
So there is I would say, it's something to be aware of it it's not particularly concerning again given the.
Improved technology event than most of the world are working with relative to maybe 20 or 30 years ago.
Great. Thanks.
Thanks, Matt.
Thank you. Our next question comes from Byron I mean with Jefferies. Your line is open.
Yeah, Hi, Thanks for taking my questions, maybe on keepsake with the trial starting in Q3 of this year and interim data in 2021, how much data do you think you'll have at that interim where you now.
That would I guess in form.
Give you information on next steps forward.
Yeah. So high that so were the study.
As you know, it's 120 patients and were where you would expect to have a little bit under half of.
Some level of maturity out a little bit under half of those patients. So probably in the range of 50 patients with with some degree of maturity I'm, sorry, So thats the target for the interim.
And.
How much how would you require before routing before conducting in Enron on those 50 patients.
So yeah, we would like to have at least a couple of stance on on most patients. These are you know as you know that would be driven by expectations for the control arm and how long.
Do you expect these patients too.
The PFS.
That is expected to be like and were again based on historical data, which we've talked about you know I think.
Four months is it reasonable timeframe to expect.
Yes.
I mean, you get that so that's sort of drives the duration and follow up some four to six months would be.
Finally, we would give us a good deal for for the Dana.
Great. Thanks for taking my question.
Yeah.
Thank you and on next question comes from Jim Birchenough with Wells Fargo. Your line is open.
Good afternoon Knutsen NYK on Cogen this afternoon.
Just going back to a.
Probably the combination trials so.
The Hi, Bryan said until we got in this trial is continuing in expansion. So does this mean that you has passed that's predefine efficacy threshold for early analysis or is that just running a little bit behind is yet to reach that stage.
Yes. This this study started a little bit Hey, Nick and this study started a little bit later than the other one it was a couple of months time and in terms of when it started and then.
Actually the dose escalation because of the nature of the combination.
I haven't.
Couple of extra levels to it and then and then Kogut hits I was just running a little behind the other studies.
Okay, and then going back to the 11 58 trials.
I know its clinical trials dot Gov has.
Post the checkpoint inhibitor chemotherapy trials now close to enrollment.
But the numbers that were enrolled hello, substantial well less than anticipated.
70, 64 vessels for 24, and 149 vessels to 49.
Why was that.
Yes, the those the numbers that are in.
Trials back of are always or at least the way. We do it is to include the highest possible enrollment assuming every cohort is maximally enrolled I'm, including both expansion cohorts and so for example, we sort of Max that number out when we put it into their so and so we would be.
You know surprising for us to to ever really enroll the full number.
Because we've we've assumed you know everything fully enrolled including for example, with having two stage design every cohort goes to sign the second stage at the same into stage.
Right. So so just reflects that you know not <unk>, yeah, we didnt Max out every element of the study.
Okay. Thanks.
And I see two a coal I'm not sure if it was the ESMO after that.
In a previous versions of the slight tickets currently slide 27 of the deck, where I Miss as colorectal was shaded out I suppose screens had a negotiated out I seem to recall that on a pause to Simon two stage, but that's no longer shaded invested into current deck. So.
'cause I kept that wrong or worse.
In some sort of reversal here.
Okay.
No.
I said, there's no intentional reversal there I can't speak to the shedding I can't I don't exactly remember, but you are right you remember that we talked about that and at the has no presentation that and that the head and neck cohort had passed onto stage to the epicord and that.
It's continue to enroll and we have not provide an update.
This change in the slide deck and more there's no intentional changing the slide deck to reflect a change in the status of that that cohort.
Okay.
And then so.
Would we be expecting to get some updates on this trial later on this year old or is that something 2021.
That's a good question.
As we as we have said in the past this is a group of collaborative.
An effort, then something where you work on 'em closely with with our partners that insight and so you know once we're able to.
You know line on a on a strategy for the presentation. We will you know we will we will let you know what that timing looks like.
Okay, great. Thank you very much.
Yeah. Thanks. Thank you. Our next question comes from Arthur He with H.C. Wainwright. Your line is open.
Hey, good afternoon, Thanks for taking my question.
The Austin for arcade. So I just had a question regarding the baby to 80 program.
Have you guys starting to dosing of patients a yes, or I just try to initiate their site and Oh when could we expect some data updates on these programs.
Yes. So we have started dosing patients. We have you know it we are enrolling the first cohort and and that's you know in this sort of.
It's going to say postcode, it but I'm not.
I'm not exactly postcode it but during this during the pandemic. We're we're happy that we had been able to get this open and start enrolling in terms of timing. You know this study is a dose escalation Ah. So we will be going through you know various dose levels.
And then and we've included.
In addition to looking at safety. We've also included some markers of on target activity.
Yeah in including and looking at you know Argentine levels themselves I'm looking at nitric oxide excelled nitric oxide.
We can look at.
The CSAPR function itself through the sweat chloride test and and as well as at TV. One so we won't be able to generate some data along all of those endpoints.
I think most likely that'll be a 2021.
Timeframe for being able to present those data.
Thanks for that and just a follow up on that Oh, So I just wondering what the old Guy the long term strategy on these programs.
You can provide some color on that.
We appreciate thank you.
Yeah, I mean, when you say long term strategy. So we the planned for.
This program is to treat patients with cystic fibrosis, we can treat as you know this is not dependent on specific indications, but all patients with cystic fibrosis would be eligible to receive the therapy and that's how we plan to develop it so in sort of a mutation agnostic way, we would move onto.
Randomized phase two trial identify the optimal dose to move forward then eventually into into pivotal studies. So thats. The general approach, we will combine with whatever therapies patients are currently receiving so we would put it on top of any other therapies their patients receiving.
It would be mutation agnostic and you know we went to really go from there.
So I was assuming you guys tend to keep it at that as Youre only a sad for long term.
Is that reasonable assumption.
Hi, Yes, I think that is probably several assumptions were fully prepared to continue on after this initial dose escalation and do you.
Randomized phase.
Hey teams in three study that Keith just mentioned.
In the future, we could certainly seek a partner, but we're very comfortable continuing the clinical development.
Oh, Thank you very much and congrats on the progress. Thank you.
Mhm.
Thank you I'm not showing any further questions at this time I'd like to turn the call back your speakers for any further remarks.
Thank you said, hey, and thanks, all for joining us today and have a great evening everyone.
Ladies and gentlemen. This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a good day.
Oh.
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