Q1 2022 Calithera Biosciences Inc Earnings Call

May 10, 2022

Ladies and gentlemen, thank you for standing by and welcome to <unk> Biosciences <unk> planning to earnings at this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require assistance during the conference. Please press <unk>.

On your Touchtone telephone I would now like to turn the conference over to your host Ms. Daphne Huang. Please go ahead.

Thank you <unk> good afternoon, everyone welcome to our first quarter 2022 conference call. Joining me today are Susan Molineaux, our founder President and CEO and <unk> Chief Medical Officer.

Earlier. This afternoon, we issued a press release, which included an overview of our first quarter 2022 financial and operational results, which 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 provisions under the private Securities Litigation Reform Act of 1095.

Actual 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 factors section of our periodic filings with the SEC.

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.

Subsequent date.

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 that this call is being recorded and with that I'll turn the call over to Susan.

Thank you Stephanie good afternoon, everyone and thank you for joining us for today's conference call.

Health care to talk to an exciting start in 2022 as we continue to advance our pipeline of investigational small molecule oncology compound to address the needs of biomarker defined patient population.

We also strengthened our balance sheet with the close of our underwritten public offering of $10 million in gross proceeds.

April of this year, resulting in $8 5 million of net proceeds after deducting underwriting discounts commissions and offering costs focused.

Focusing on our clinical pipeline, we have made significant progress in completing the transfer of microphone and so patents circuit materials from Millennium Pharmaceuticals, a subset subsidiary of Takeda pharmaceutical company.

<unk> and are well into site startup activities for phase II monotherapy trials for each compound we remain on track to begin enrollment in these trials in the second quarter of this year and expect to share data by the first quarter of 2023.

We believe that by focusing on well characterized genetic vulnerabilities with molecules that have already shown single agent activity, we will be able to generate phase II data with targeted efficient <unk> designs and provides potential paths for rapid approval in genetically defined patient populations.

Turning to our preclinical pipeline, we have continued to advance our internally discovered preclinical pipeline of synthetically followed the targets.

Notably Vps, <unk> and Vps for B, which are parallel jeans were a loss of one or the other <unk> and cancer cells is synthetically lethal.

In April we presented data describing vps score a inhibitors at the American Association for cancer research or ECR 2022 annual meeting.

That presented poster detailed our discovery of what we believe to be the first active arm target vps for inhibitors.

Emma will describe our findings in further detail we are continuing to advance multiple inhibitors in series lead optimization and look forward to updating you on our progress as they advance towards first in human clinical studies.

In February of this year. We also received good news from our partner MTGE investment, who announced the approval of our first in human study of Atg <unk> seven formerly CB 708 in patients with locally advanced or metastatic solid tumors Atg <unk> seven was discovered by Calif era and in May of 2020.

Martin we entered a license agreement with Amgen, Jean where we granted them an exclusive worldwide license to develop and commercialize atg <unk> seven which is a CD 73 inhibitor under this agreement <unk> received an upfront payment of $3 million and may receive potential development regulatory and sales milestones of up.

To $250 million.

I would like to announce also that we have decided not to pursue further development of CB 280 in CF cystic fibrosis. At this time, we will dedicate our resources towards the oncology programs, while TV <unk> showed encouraging safety and biomarker data in the completed phase one study in CF patients.

We came to this conclusion after reviewing our data and in addition to evaluating the impact of recent significant changes in the CF therapeutics and regulatory landscape.

And now I will pass the call over to Mlps go into additional details on our program.

Great. Thank you Susan I'd like to start today by providing some additional detail around the data presented at ACR in 2022 on our novel Vps <unk> inhibitors.

The poster detailed talent there is discovery of bps <unk> inhibitors. These data validate the synthetic lethal interaction between the gene catalogs called Vacuolar protein sorting associated protein for ray or bps, <unk> and vps quarter B.

We believe that these data provide the first preclinical evidence supporting a newly discovered series of compounds designed to target. These proteins for cancer treatment we.

We mined CRISPR genetic loss of function data and associated molecular datasets from the broad Institute.

And Harvard's cancer dependency map project dataset to identify chairs with gene catalog, which we then prioritize for potential drug targets.

This work resulted in the identification of Vps, <unk> and Vps for B as promised on target.

Simultaneously knocking down bps 40, mbps for be consistently resulted in cell that we then conducted multiple studies to validate the catalog Jean Pierre demonstrating that sells with bps or be homozygous or heterozygous loss.

Sensitive to EPS for a knockdown, while it felt without vps for B are not utilizing the VTS four bps for beef catalog gene targets. We identified a novel series of small molecule inhibitors. Among the finding shared at the ACR Congress or data detailing the performance of one inhibitor of Vps <unk>.

And Vps Gorby hepa's activity.

Turning to our clinical pipeline. We are currently activating sites for the phase III trials of <unk> in patients with relapsed refractory non GCB also commonly referred to as <unk> with and without <unk> 88, or <unk> 79 mutations as.

As well as dependent started in patients with relapsed or refractory <unk>. Two also known as <unk> mutated squamous non small cell lung cancer. Both trials are on track to begin enrollment in the second quarter of this year.

The phase II trial of <unk> asserted planned as a two part study.

As a monotherapy study in patients with relapsed refractory <unk> mutated or wild type squamous non small cell lung cancer as detected by next generation sequencing the objectives of the phase Iia dose refinement and confirmation of the selective activity in nerf <unk> mutated tumors compared to wild type tumors Tobey.

To validate and RFP mutation as the selection biomarker.

As Iia data are intended to substantiate the single agent activity that was already seen with the kind of search data and patients with relapsed refractory <unk> mutated.

Squamous lung cancer and also evaluate its activity in RF to wild type squamous lung cancer. We believe that if we successfully achieved the objective of phase Iia, we will be able to initiate phase two b.

And the relapse and the same relapsed refractory <unk> mutated squamous lung cancer population, which could be registrational.

The specific design of phase III will be informed by data from phase Iia and may be a single arm expansion cohort evaluating <unk> asserted in relapsed refractory <unk> communicated squamous lung cancer patients at the selected dose and or a randomized study comparing the selected dose dependent circuit to standard of care salvage therapy.

Subsequent development in squamous lung cancer could involve monotherapy <unk> in combinations with standard of care therapies in earlier lines of treatment within the biomarker defined subpopulations of <unk>.

RFS II and keep one tumors nerf too and keep one mutations have been detected across several tumor types combined frequencies of up to 27% providing additional indications for development is dependent started as a monotherapy or in combinations in tumors beyond squamous non small cell lung cancer now turning to <unk>.

I have a vote.

We're initiating a two part phase two trial in patients with relapsed or refractory non GCB or <unk> as defined by the standard Hans algorithm with enrichment for minus <unk> 88, and <unk> 79 being mutations.

Cte DNA based liquid mgs.

The phase Iia part of the trial will confirm activity in the biomarker defined subsets and further refined dose and schedule. This trial is also on track to enroll first patient in the second quarter and we expect to share data by Q1 2023 data from this study will inform phase II, b, which would potentially enroll expansion cohorts comprised of.

Patients with relapsed refractory non GCB, <unk> minus 8% or 370, <unk> mutant <unk> or bulk with the primary endpoint of overall response rate such.

Such a study could enable an accelerated approval pathway for my voting as a single agent in these biomarker defined subsets Michael.

<unk> has the potential to be the first treatment specifically for non GCB.

<unk> a population of patients with the historically poor prognosis and unmet clinical need. It also has the potential could be the first treatment for genetically defined subset of <unk>, mainly patients with <unk> 88, or <unk> 79 mutations.

We plan to pursue combination strategies with novel <unk> standard of care therapies to further expand development in earlier lines of therapy in <unk> additional paths for monotherapy and combination development include other non hodgkin lymphoma like while the terms of macro global anemia, where the majority of tumors are known to have <unk> mutation.

Our other indolent lymphomas, where <unk> has already shown compelling single agent responses in previously completed trials with that I will pass it over to Stephanie for an update on our financials.

Thank you Emily data financial results were included in today's press release I will briefly review our results on this call.

Cash and cash equivalents totaled $44 7 million at March 31, 2022, which we expect together with proceeds from our recently completed public offering will be sufficient to meet our operating plan through the second quarter of 2023.

R&D expenses for the first quarter 2020 were $9 6 million compared to $15 3 million in the same period last year.

Decrease of $5 8 million was primarily due to a decrease in the telephone if that program, partially offset by increases in instant payments and <unk> programs G&A expenses for the first quarter of 2020.

Two were $4 3 million compared to $5 4 million in the same period last year, a decrease of $1 2 million was primarily due to decreases in personnel related costs net loss for the three months ended March 31, 2020 was $13 8 million.

With that I will now turn the call back over to Susan.

Thank you Stephanie and with that operator, we're happy to open the line for questions.

Thank you ladies and gentlemen, if you have a question at this time. Please press Star then the number one key on your Touchtone telephone is your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

And your first question comes from the line of Jonathan Chang from <unk> Securities. Your line is open.

Hi, guys. Thanks for taking my questions first question it looks like there'll be a panacea to plus our.

Our startup phase <unk> combination data.

I'd ask go from a study that was initiated before you guys and license the drug.

My question is can you guys help set expectations ahead of those data.

Much new data will be available versus previous disclosures.

Oh I can answer that.

Essentially this was this study that was initiated well before we took.

Took the program.

So I wouldn't be able to provide guidance on that on that question again, because it wasn't a study that we had initiated.

Got it.

And second question what are the remaining steps to initiating the might've gotten there.

<unk> phase II studies.

I mean like we said the studies are already essentially being initiated.

We opening sites at the moment.

And so again were.

<unk> enrollment of the first patient in the first half of this year and still guiding to data in Q1 'twenty three.

Got it and just last question for me.

Can you provide more color on the C 73 inhibitor partnership with anthem gene and Spa.

Pacific Creek can you elaborate on any potential near term milestones you could receive.

Yes.

Hi, Jonathan It's Stephanie as you know, we received the upfront of $3 million and $250 million to $10 million in future milestone, we haven't provided any more guidance beyond that but.

We are pretty excited that that study is about to be underway.

Got it thanks for taking my questions.

Thank you.

Your next question comes from the line of Nick Abbott from Wells Fargo. Your line is open.

Hey, good afternoon, Thanks, taking my questions first one.

In the prepared remarks.

And I apologize.

I missed the first part of the coal so the prepared press release released CB 280 is not discussed.

Is there an update on that program.

Yes, Nick I can answer that so basically as you know we showed data from the phase one b trial sort of interim data from that escalation, where the drug showed excellent safety as well as encouraging trends.

Both in terms of PK PD as well as biomarker. So type of molecule did what it was supposed to do for the purpose of that study, which is safety PK PD and Biomarkers and the reason that we decided not to pursue go right into the next stage of development, which would be phase two.

Population was really the dramatic shifts in the treatment landscape and really the regulatory landscape and what I mean by that is with the approval of the.

The highly effective modulators.

Namely tried cap debt, it's really shifted.

The unmet need population within the disease and so it's in that it's a matter of active debate both within the academic community as well as amongst the regulators in terms of what is the population now in CF.

Is it the standard historic clinical trial population that one should test the new drug in.

And what are the bars for efficacy with regards to <unk>, one and other endpoints and I think this is a.

Problem.

Not really a problem it's good for patients, but it's actually being discussed actively with them to see.

If community. So we thought that it was premature to go into that.

That phase II study without answers to these questions in the field already determined and plus we want to dedicate our resources to the new oncology programs. So it was really a portfolio prioritization.

Yeah.

Okay very comprehensive so.

It's another opportunity to partner that.

The companies, who have sort of more expertise or focus on.

Okay.

Yes, I mean at this point, we're not developing the molecule going at this time as we said but.

We said if there is potential for that I think we'd be open, but I'll hand, it off to Susan if she wants to add anything more.

I would say the same thing I mean, we will monitor the CF landscape and if there are opportunities for partnership we'll certainly pursue them and we can revisit at a later date, but for now we're not planning on taking CVT.

Directly forward in that trial.

Okay. Okay. Thank you and then on the DSP.

<unk> inhibitors.

We saw the data at <unk>.

What do you think the timeline is too.

An IND filing.

That program.

Yeah.

We're currently in lead optimization for that and we hope to advance a program that can give you a future guidance on.

Be in the clinic, but we can't guide to that at this moment.

Okay fair enough. Thanks Hello.

Thank you and your next question comes from the line of <unk> <unk> from H C. Wainwright. Your line is open.

Thank you.

Some of the questions that I had.

Have been answered, but in general Susan and Stephanie.

Just trying to understand how.

We are trying to optimize your resources.

Good too.

Pretty much.

Our clinical programs are pretty much have started.

Under the program, which is.

It's probably can get started maybe a year and half from now.

How do you see your resources being used.

True.

Getting to this three.

<unk> pipeline product.

In the sense is there going to be some some sort of staggering between the three programs or you can run phase III.

The extent.

You would have data.

In the next year or so.

You need to go back to the market.

<unk>.

Hi, RK.

Any.

Current cash runway is.

The first half of 2023, and we anticipate having data from.

Clinical assets in the first quarter. So I think we have sufficient cash withdraws.

To optimize that as well.

Put some efforts into the synthetic with holiday program.

Okay perfect. Thank you.

Yeah.

Thank you. Your last question comes from the line of Ada Hussain off from Ladenburg. Your line is open.

Hi, Thank you for taking my questions.

I have one regarding the timelines so could you clarify how long would it take you to enroll patients in each of the micro what may slip in.

You start the trials and so I see that you're right now of course this quarter 23 before the cordless fourth quarter 'twenty to first quarter of 2003. So do you expect that guidance to change.

We move forward into this year.

Yeah.

No we're still guiding to <unk> 23 for data like we have said earlier. These are open label response rate endpoint studies in two drugs that we already know from earlier trials.

So very quick responses and the signal is pretty binary in terms of their efficacy.

So we do expect to be able to still generate data.

In Q1 'twenty three.

The pace of site Activations that we're currently seeing.

With the two studies together.

We're still confidently guiding to that timeline.

Could you clarify how many patients in each of the trials Youre planning to enroll and given the early responses, where do you see where do you expect to see earlier.

Responses and which of the trials.

Yes.

These two are the phase Iia part of these studies as I said in the.

Prepared remarks is essentially.

Substantiated previously observed efficacy so.

From the standpoint of.

Seeing a positive signal of efficacy, we don't think we need that many patients.

To be able to determine whether or not we're seeing confirmatory activity that was already previously seen.

Studies, and we're working with sites that have high volumes of patients who frequently do mgs on all their patients. So that patient identification is the main very easy.

So to that point again, we think we will have a meaningful data set that guide us to the next part which is phase two b for both studies within that timeframe.

Okay.

Got it got it and the last one.

Given this focus traded right now would you consider licensing one of the programs are focused on another I know you probably don't have a preference one over another but would you would you consider kind of focusing just on one asset one indication.

As opposed to developing two assets at the same time.

I mean, we think both drugs have really good value, which is exactly why we got both of them and we think both of them have really strong potential to be successful and be real drug. These biomarker defined group so.

No I don't think we would prioritize one over the other at this point.

Got it got it. Thank you appreciate it.

Thank you and I'm showing no further questions at this time I would now like to turn conference back to our President and CEO Ms. Susan Molineaux for any closing remarks.

Thank you Grace and thanks, all for joining us today have a good evening.

Thank you ladies and gentlemen. This concludes today's conference call. Thank you all for joining you may now disconnect.

Okay.

[music].

Sure.

[music].

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

No.

Okay.

Yes.

Okay.

Yes.

Okay.

[music].

Okay.

Yes.

[music].

Okay.

Yes.

Okay.

[music].

Okay.

[music].

Yes.

Okay.

[music].

Okay.

Yes.

Thank you.

Okay.

Sure.

Okay.

Yes.

Okay.

[music].

Yes.

[music].

Okay.

[music].

Yes.

Sure.

Yes.

Yeah.

Yes.

Thanks.

Okay.

Yes.

Okay.

[music].

Okay.

[music].

Yes.

Okay.

[music].

Okay.

Yes.

Alright.

Okay.

Sure.

Yes.

Okay.

Yes.

Okay.

Sure.

Yes.

Okay.

Yes.

[music].

Okay.

Yes.

Okay.

[music].

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Thanks.

Okay.

Yes.

Okay.

Sure.

Okay.

Yes.

Okay.

Yes.

[music].

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Thanks.

Okay.

Yes.

Thanks.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Sure.

Thanks.

Okay.

Sure.

Yes.

Okay.

Yes.

Okay.

Yes.

Sure.

Yes.

[music].

Yes.

Thanks.

Yes.

Okay.

Yes.

Okay.

Right.

Yes.

Okay.

Yes.

Okay.

Yeah.

Yes.

Okay.

Sure.

Okay.

Right.

Yes.

Okay.

Thank you.

Okay.

Yes.

Great.

Yes.

[music].

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

[music].

Sure.

Yes.

Okay.

Yes.

Okay.

Yeah.

Yes.

Okay.

Sure.

Yes.

Okay.

Yes.

Okay.

Yes.

Thank you.

Okay.

Yes.

Okay.

Yes.

Okay.

[music].

Okay.

Yes.

Okay.

Thanks.

Yes.

Okay.

[music].

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Sure.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

[music].

Okay.

Yes.

Okay.

Yeah.

Yes.

Okay.

[music].

Okay.

Yes.

Yeah.

Okay.

Yes.

Okay.

Yes.

[music].

Okay.

[music].

Okay.

Yeah.

Q1 2022 Calithera Biosciences Inc Earnings Call

Request a DemoDemo

CALA

Calithera Biosciences

Earnings