Q3 2022 Calithera Biosciences Inc Earnings Call

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

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Good day, ladies and gentlemen, and thank you for standing by walking to the Caliphs Arrow Biosciences third quarter 2022 earnings conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need to press star.

Our one one on your telephone keypad at this time I would like to turn the conference over to MS. Stephanie Wong Ma'am. Please begin.

Thank you operator.

Everyone.

Hello, and welcome to our third quarter 2022 conference call. Joining me today are Susan Molineaux, founder, President and CEO and I'm Gonna cardiac as Chief Medical Officer earlier. This afternoon, we issued a press release, which included an overview of our third quarter 2022 financial and operational results, which can be accessed through our website I'll call. It their 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 1995.

Actual results may differ materially.

These forward looking statements and as a result of various important factors, including those discussed in the risk factor section of our periodic filings with young people.

In addition, any forward looking statements represent our views only as of today.

It would not be relied upon as representing our views as of yet.

Any subsequent date, while we may elect to update these forward looking statements at some point in the future.

Specifically disclaim any obligation to do so even if our views towards.

Please note that this call is being recorded.

I will turn the call over to Susan.

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

Last quarter, we announced the initiation and enrollment of the first patient in.

Our phase two clinical trials of Microvolt, nib, and relapsed refractory non GCB diffuse large b cell lymphoma or D. L. D C L and September circuit, and relapsed refractory nerf, two mutated squamous non small cell lung cancer.

Patient enrollment is progressing there have been site activation delays that have affected both trials.

These delays have caused enrollment to fall behind our anticipated timeline and as a result, we do not expect initial data to be available until mid 2023, compared with our earlier projection of Q1.

Also based on our current operating plan, we believe we have sufficient cash to fund our operations into the second quarter of 2023.

In order to extend our cash runway, we are evaluating all options for our programs, including strategic collaboration or licensing agreements and are actively considering the sale of certain programs.

We continue to believe strongly in the potential of the patent asserted and my vote nib and their respective target patient populations and are committed to taking all steps possible to allow for their continued clinical development.

We can bring these therapies to patients.

As we announced last month, the Pentair Kipp was granted FDA fast track designation for the treatment of adult patients with unresectable or metastatic squamous non small cell lung cancer about which Emma will go into further detail shortly.

This designation provides us the ability to engage in more frequent dialogue with the FDA, which we believe will be important as we continue the clinical program.

It will also give us the opportunity to submit our marketing application on a rolling basis with a potential for priority review.

We look forward to working with the agency as we continue to advance its much needed treatment for a patient population who have typically not benefited from the standard of care due to the mutational status of their tumors.

But that said I will pass the call over to M O to provide additional details on our program.

Sure.

Thank you Susan starting with our second of surgery program in September we presented a trial in progress poster detailing the design of our phase II clinical trial in relapsed refractory and RF to our Nf L. Two mutated squame non small cell lung cancer.

As a reminder, this is the kind of circuit study is an open label monotherapy study in which patients with <unk> in patients with non small cell lung cancer, whose disease has progressed on or after platinum doublet chemotherapy and immunotherapy.

Studies evaluating two doses of <unk>, two milligrams twice daily and three milligrams once daily in patients with squamous non small cell lung cancer harboring either wild type or mutated in RFG as detected by next generation sequencing. The objectives of this study are to refine dosing and confirms kind of searching selective activity in RF.

And mutant tumors compared to wild type <unk>.

The trial's primary endpoint or investigator assess overall response rate and safety while secondary endpoints include duration of response PFS and OS.

Aleve that the data from this study could position you can kind of chip for registration enabling trial.

Excited to have received fast track designation for Spanish started one of the advantages of fast track designation is that it allows for earlier and more frequent communications with the FDA.

We plan to utilize this benefit as we plan our next steps for this program, including a path to potential registration.

Now turning to my vote Mig we are conducting a monotherapy study in patients with relapsed or refractory non GCB Dl bcl.

We're planning to enroll approximately 50 patients with and without <unk> 88, or <unk> hundred <unk> mutation pay.

Patients are being randomized into one of two cohorts continuous dosing at 100 milligrams Q daily and an induction dosing schedule of 120 milligrams to daily for 14 days, followed by 80 milligrams Q Daley beginning on <unk>.

The study are to confirm previously observed single agent activity of <unk> in.

In these patients.

Terminal activity in <unk> Bcl patients harboring <unk> 88, <unk> hundred 90 mutation and refined dosing and dose.

In these patients.

88, <unk> hundred 90 mutation status being determined using Cte DNA based liquid next generation sequencing after randomization.

The primary endpoint of the study are safety overall response rate.

Turning to the independent Radiology review with secondary endpoints, including duration of response progression free survival and complete response rate given the major unmet medical need in third line plus D. L. Bcl you believe that the data from this study if positive could be the basis for the initiation of a registrational trial targeting accelerated approval.

And with that I'll pass it over to Stephanie for an update on our financial.

Thank you Emma and I will go over here.

<unk> results were included in today's press release I will briefly review our results on this call are Ken.

And cash equivalents totaled $34 1 million at September 32022, which we expect will be sufficient to meet our current operating plan into the second quarter of 2023.

As I mentioned, we are currently evaluating all options for our programs in order to extend our cash runway.

R&D expenses for the third quarter 2022 were $6 5 million compared to $11 6 million in the same period last year.

The decrease was primarily related to decreases in a telephone at that CB 280 in early stage research programs, partially offset by increases in <unk> and <unk> programs.

G&A expenses for the third quarter of 2022 were 3.0 million compared to $6 3 million in the same period last year. The decrease was primarily due to decreased personnel related costs and legal expenses.

Net loss for the three months ended September 30 of 2022 with $9 8 million.

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

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

Yeah.

Ladies and gentlemen, if you have a question or comment at this time. Please press star one one on your telephone keypad again, if you have a question or comment at this time. Please press star one one on your telephone keypad. Please.

Please standby, while we compile the Q&A roster.

Our first question or comment comes from the line of Roger song from Jefferies. Mr. Song. Your line is open.

Great. Thank you for taking the question.

Just a few quick ones from us.

So the first one is the.

Maybe Susan you can elaborate.

<unk>.

And how confident you are.

You will.

<unk> data by mid next year, and how to improve the hallmark given big environments.

And also the follow up question relates to the timeline. That's why are there given you're considering all options for our pipeline and how much this partnership.

Discussion will depending on all the.

The phase II data about your Readouts. Thank you.

Thanks Roger.

I can comment and then I will pass it along to them all for some more specific comments.

So in general.

We again do not expect our current data to be available until mid 2023 and that will be our initial clinical data on both <unk> and my vote nib.

We are experiencing site activation delays we expect.

The Gators once they're open to be enrolling patients on both of these trial, we believe in our drugs and we believe that we are just up against some operational issues at the clinical sites. So we feel comfortable that we will have the initial clinical data by mid 2023.

We do not.

We do not need to have that phase two initial data to continue exploring options for increasing our cash runway.

There are things, we can do today to increase our cash runway and then we would expect ta to initial data from both programs in mid 2023.

Got it.

Okay.

Yes, Im not sure if Apple will have additional comments, but thats good.

Sorry, Roger I was on mute I didn't realize.

Yes, I mean, just I don't have much additional comments with inclusion has that I mean, essentially the main thing that.

Happened over the last quarter was really activation delays in some of the states owing to mostly.

Several reasons, but including post pandemic staffing shortages that several sites.

Being recognized as a pretty widespread issue.

And so several sites that represented the accurate in Q3 or actually activating this quarter, which is hence the reason for the delay in our.

Our enrollment.

But as Susan said once the sites are up and running we expect them to put patients on.

Got it okay great.

And also you do have.

Some of our earlier pipeline, maybe just summarize trs outside of those two.

The clinical pipeline what else pipeline in particular for that.

<unk> four program.

Pretty promising.

The status for that program.

Thank you.

The status of the passport program is as we stated before it's moving forward and we will be able to update on that program.

I forget if you were asking about other programs.

That's our preclinical pipeline and vps for.

Got it thank you.

That's helpful.

Thank you.

Our next question or comment comes from the line of swap <unk> from H C. Wainwright.

Mr. Amit Thank you.

Thank you this is RK from H C Wainwright.

Good afternoon Susan.

Hi, RK.

So.

From your commentary you said.

Multiple options.

Are termed.

Two to bring them I'm guessing these are all non.

Non dilutive forms of.

Cash so.

Okay.

To the extent you can kind of give us a flavor of what sort of things you're thinking off.

From from your commentary at least it looks like you want to keep.

Im not talking about the two clinical programs at this point so.

Does that mean.

EPS for US is in play in terms of.

In terms of installations.

Our relationship with.

Collaboration of some sort or.

Even out licensing.

Is that what we should understand.

I don't think we know enough at this point to make specific.

Comments.

We continue to evaluate all the options on our programs and that included include strategic collaborations or licensing agreements and we are considering the sale of certain programs, but I can't give you a more detailed than that at this time, because we don't know.

Okay fair enough.

<unk>.

In terms of.

And our data.

Come in Europe .

Sometime in the first half of next year.

How much data do you think you could have.

Justin.

Just in case, you would need to make.

And the intelligent conversation about these two programs for for the partnership.

Situation.

I think that depends very much on the quality as well as the quantity of good data.

No. These are open label program there in specific genetically defined populations of cancer patients.

And it.

It is.

Because it's open label, we can see the data and we're looking for.

<unk>.

The amount of data that would tell us definitively that we can move forward with these programs. I mean these are both drugs that already have demonstrated single agent activity in the populations that we are testing and now and this is really safety and dose refinement.

Jeff.

Trying to get confirmation that the data look the same as they did in prior studies. So I don't think there is a hard number you can put on it but we would like confirmation for both these programs.

That asics as we expect to drugs have single agent activity in these specific population.

Perfect.

Thank you very much for taking my questions and good luck I'm Dr.

Great. Thanks RK.

Thank you.

Our next question or comment comes from the line of Matthew copper from SBB Securities. Mr. Copper. Your line is now open.

Okay.

Hey, guys. This is Matt Brown for Jonathan Chang, Thanks for taking my call taking my question.

It looks like if we hold opex flat for the next few quarters you have runway into the third quarter next year I was just wondering if you could clarify what assumptions drive your runway guidance. Thank you.

Hi, Matt its Stephanie we don't typically disclose that level of detail you can see we have considered various scenarios of marriott's option and so we're exploring all of them for all the programs.

And thinking about the right way to extend the cash runway.

Got it thanks.

Thank you.

Next question or comment comes from the line of <unk> Hussain of from Ladenburg Mr. <unk>.

Your line is now open.

Hi, good afternoon, everyone. Thank you for taking my questions.

I was just wanted to elaborate on a couple of questions that were asked before so.

The delays in both studies could you elaborate a little bit on this delays and just give us a better understanding weather.

These unknowns.

Unknowns in the beginning.

Of the year. So how come we just know this just now and these are not COVID-19 related delays, assuming could be staffing, but how come we didn't notice at the beginning of the year.

Yes, I can answer that again both of these.

The delays were really unexpected in the sense of.

The various reasons.

Curt across different sites the projections.

From both the site level and <unk> level in terms of overall activation times.

We're essentially progressing.

Land and some several sites had sort of unexpected delays due to various reasons.

I guess most of the common reasons, we're staffing staffing issues.

Got.

Essentially were unpredictable and known to be an issue that's still ongoing.

Ross the country.

And so every cycle is different but again it was something that hit us.

Got more realized around the last quarter in terms of their actual impact on the studies.

But again the sites are activating.

But they were delayed by about a quarter and the majority of cases.

They open up we expect that the.

The enrollment curve is going to get steeper.

Okay got it thank you Emil.

And regarding the potential sale of one of the assets.

Could you could you tell us whether there is any sub licensing fee if you.

<unk>.

Due to the sub license agreement too.

Peter or millennium.

Whatever company.

He was responsible for for this in licensing, but it did it you to do the debt back in 2021.

We went into the car.

Comment on the specifics of that since it would depend on the way the transaction is structured to difficult tin for Brett I can say that the agreement is filed publicly with the SEC and it's available on breathing oven conditions for something like a sub license.

Okay.

And last question is.

Would you consider.

Sort of putting a pause on one of the trials in order to extend the cash runway. If you don't find a suitable partner or a collaborator.

Yes.

We are evaluating all options for all our programs and so.

<unk> see anything specific about them, but that would be something that we would consider in order to extend the gas really.

Got it okay. Thank you very much.

Thank you I'm showing no additional questions in the queue at this time I would like to turn the conference back over to MS. Molineaux for any closing remarks.

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

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program you may now disconnect everyone have a wonderful day.

Yeah.

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

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Okay.

Okay.

Okay.

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Yes.