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Calithera Biosciences Inc (NASDAQ:CALA)
Q1 2021 Earnings Call
May 6, 2021, 5:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, and thank you for standing by. Welcome to the Calithera Biosciences First Quarter 2021 Earnings Call. [Operator Instructions]

I would now like to hand the conference over to your first speaker today, Stephanie Wong. Please go ahead.

Stephanie Wong -- Chief Financial Officer

Thanks, Jeff. Good afternoon, everyone. Welcome to our first quarter 2021 Conference Call. Joining me today are Susan Molineaux, Founder, President and CEO; and Keith Orford Chief, Medical Officer.

Earlier this afternoon, we issued a press release, which included an overview of our first quarter 2021 financial and operational results, which can be accessed through our website at calithera.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 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 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 will turn the call over to Susan.

Susan M. Molineaux -- Founder, President & Chief Executive Officer

Thanks, Stephanie, and good afternoon, everyone. Thank you for joining us today on our first quarter 2021 conference call. On behalf of the entire team, I'd like to say, we hope that you and your friends and families remain healthy. As the world continues to push forward to contain COVID-19, we are grateful to the scientists, companies, and frontline workers that have worked to achieve monumental milestones in developing and deploying vaccine. Their dedication has allowed many of us to return to some sense of normalcy and allowed people to return to their medical centers for treatment of serious illnesses like cancer and cystic fibrosis where Calithera is working to develop novel drug therapies that will make a difference to patients.

In the first quarter, we have been busy advancing our two key clinical programs, which both have data readouts expected later this year. First, the randomized KEAPSAKE trial has continued to enroll non-small cell lung cancer patients. KEAPSAKE is evaluating telaglenastat in combination with standard-of-care chemoimmunotherapy for first-line non-small cell lung cancer patients with KEAP1 or NRF2 genetic mutation. We anticipate releasing interim data for this trial in the fourth quarter of 2021. We also continue to evaluate telaglenastat in additional indications and combinations and in investigator-sponsored trial.

Secondly, our oral arginase inhibitor, CB-280, for the treatment of cystic fibrosis is continuing to enroll patients in a Phase 1b dose escalation trial. As you know, our interest in arginase stems from the inside 1158 molecule that is partnered with and being developed by Incyte for the treatment of cancer. Arginase also plays a critical role in cystic fibrosis airway disease and arginase inhibition could be a potential treatment. We identified TB-280, a first-in-class oral arginase inhibitor wholly owned by Calithera for evaluation in this patient population. According to third-party market research, there are over 70,000 people living with CF. [Indecipherable] recent advances in treatment with CFTR modulators, many patients still have impaired lung function. This is an area of unmet need for people with CF, that CB-280 is poised to potentially fulfill. We expect to announce data from our ongoing trial in the second half of 2021. We are also pleased to have the support of the Cystic Fibrosis Foundation, including an award of up to $2.4 million for the clinical development of CB-280 and look forward to continuing to work with them.

With our broad pipeline and milestones expected this year in the KEAP1/NRF2 and CF program, we are looking at an exciting 2021. Calithera has always had an exceptional discovery, research and development team and paired with our experienced management team, diverse in their capability, we are eager to forge ahead in our vision to provide novel therapeutics in areas of high unmet need.

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

Keith Orford -- Chief Medical Officer

Thank you, Susan. And I'll start by providing an update around telaglenastat, our glutaminase inhibitor. We are evaluating telaglenastat in a non-small cell lung cancer patient population with a targeted biomarker-driven approach in the KEAPSAKE trial. Over the last couple of years, retrospective analysis have shown that non-small cell lung cancer patients with KEAP1 or NRF2 mutations have poor prognostic outcomes in wild-type patients and that these patients may not respond well to standard-of-care chemoimmunotherapy. KEAP1/NRF2 driver mutations protect tumors from oxidative stress and promote tumor growth and survival. Preclinical models have shown that activation of a KEAP1/NRF2 pathway makes tumors dependent on glutaminase activity for growth and survival, making these tumors exquisitely sensitive to inhibition of glutaminase activity by telaglenastat.

In the KEAPSAKE trial, patients are randomized to receive telaglenastat or placebo in combination with pembrolizumab, carboplatin, and pemetrexed. The study will evaluate the safety and investigator-assessed PFS of telaglenastat plus this standard-of-care chemoimmunotherapy regimen. We plan on enrolling 120 patients and begin enrolling this study in September 2020. This is an area of unmet clinical need as an estimated 20% of non-squamous, non-small cell lung cancer patients have tumors harboring KEAP1 or NRF2 mutations. Based on preclinical studies that provide a strong mechanistic rationale the central role of glutaminase and driving proliferation in non-small cell lung cancer tumors harboring KEAP1/NRF2 mutation, we believe that the KEAPSAKE trial has the potential to improve outcomes for these patients and we look forward to being able to share interim data in the fourth quarter of this year.

We are also continuing to assess the combination of telaglenastat with the CDK4/6 inhibitor palbociclib in non-small cell lung cancer, colorectal and pancreatic cancer patients in an exploratory Phase 1b/2 trial that we are conducting in collaboration with Pfizer. Earlier this year, we announced results from the CANTATA trial which evaluated telaglenastat with cabozantinib in an all-comer population of renal cell carcinoma patients that have progressed on immune checkpoint inhibitors or antiangiogenic therapies. This trial did not meet its primary endpoint of improving progression-free survival. The final analysis from this study will be presented at the ASCO Annual Meeting in June. While we're disappointed with the CANTATA results, we believe this study adds to the field by presenting outcomes of contemporary population of patients treated with cabozantinib in the second or third-line setting and we look forward to presenting these data at ASCO. We have no plans at this time to continue developing telaglenastat in renal cell carcinoma.

Moving on to cystic fibrosis, in 2020, we announced the initiation of the first clinical trial to evaluate our novel oral arginase inhibitor, CB-280 in CF patients and enrollment has been proceeding as planned. The depletion of arginine in cystic fibrosis patients by the enzyme arginase results in reduced production of nitric oxide and increased production of polyamines and proline. Inhibition of arginase should increase nitric oxide, increase antimicrobial effects and improve airway function. Preclinical studies demonstrated CB-280 treatment, significantly improved lung function and reduced lung infection in CFTR deficient mice. The Phase 1b study is enrolling approximately 32 patients that are on a stable regimen of CF therapies and have chronic airway dysfunction and will be randomized to receive either placebo or CB-280 in dose-escalating cohorts. Importantly, the trial is designed to demonstrate that this drug can safely be added to existing standard of care therapies for CF including CFTR modulators. We plan to share data from this trial in the second half of 2021.

In addition to these ongoing clinical programs, we have clinical candidates for both in oral CD73 inhibitor, CB-708 and in IL-4I1 inhibitor, CB-668 which targets peroxide, kynurenic acid, immunosuppression in the tumor microenvironment and we are continuing these preclinical studies.

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

Stephanie Wong -- Chief Financial Officer

Thank you, Keith. Detailed financial results for the current quarter were included in today's press release. I will briefly review our results on this call. Calithera remains well-capitalized with cash and investments totaling $102.9 million at March 31, 2021. R&D expenses were $15.3 million in the first quarter of 2021 compared to $20.1 million in the first quarter of 2020. The decrease was primarily driven by decreases in the telaglenastat and 1158 program. G&A expenses were $5.4 million in the first quarter of 2021 compared to $4.9 million in the first quarter of 2020. The increase was primarily related to increases in personnel-related costs, partially offset by decreases in professional services. Net loss for the first quarter 2021 was $20.4 million.

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

Susan M. Molineaux -- Founder, President & Chief Executive Officer

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

Questions and Answers:

Operator

Okay, thank you. [Operator Instructions] I will first speak -- our first question comes from the line of Mohit Bansal of Citi. Sir, your line is open.

James -- Citi -- Analyst

Hey, guys. This is James up on for Mohit. Thanks for taking my question. Just two quick ones. For KEAPSAKE, you sort of given us expectations for the control arm, but can you sort of consider -- can you share like what you would consider to be good ORR in PFS data for the patients on telaglenastat? And then related to KEAPSAKE, for the 4Q readout, are you planning to release data in a press release or is that something that you could reserve for like a larger medical conference? Thanks.

Keith Orford -- Chief Medical Officer

Hi, James. So in terms of the data, yeah, as we've talked about before kind of what we would expect the ballpark to be for the control arm, maybe a median PFS in the three to five months range, in terms of what good data looks like, I mean, I think the key point is that we're looking for this to be a substantial improvement over the control arm and over how poorly these patients do today. So we're really not looking for really small incremental improvements. So I hesitate to provide a specific number or a specific PFS. But the goal here is for it to be a clear improvement and we're not looking for something subtle. Presumably, when all is said and done, that's something you need a statistician to determine, to put it that way. And then in terms of how it will be done, I think we're not necessarily going to wait for a medical conference. We'll see what -- based on the timing, how that works out.

James -- Citi -- Analyst

Got it. Appreciate it, guys. Thank you.

Keith Orford -- Chief Medical Officer

Yeah.

Operator

Thank you. Next question from the line of Matt Phipps of William Blair. Your line is open.

Rob Andrew -- William Blair -- Analyst

Hi, guys, this is Rob Andrew here on for Matt Phipps. Just a couple, if I may. So, first one, it was an interesting presentation a couple of weeks ago here at AACR. That was kind of highlighting ferroptosis as a key pathway through which T cell-mediated killing of tumor cells occurs and it seems in the literature that some evidence that NRF2 could be involved in this pathway since it's kind of cancer regulated by glutathione. And then similarly exports of intercellular glutamate has been linked to suppression of the pathway as well. So we were just kind of wondering whether you've seen any evidence preclinically that telaglenastat can influence ferroptosis pathway? And whether there's potential to think here that that could be an additional mechanism of action for telaglenastat? And then the second question is just kind of similar to a previous question on KEAPSAKE but on CB-280. Just on what expectations are there in terms of the data is in conjunction with the medical meeting or expecting top line results press released? Thanks.

Keith Orford -- Chief Medical Officer

Yeah. Hi, Rob. Yeah, so I think the story around ferroptosis is an interesting one and certainly a developing one. I think not an area of focus, particularly earlier on in the development of the program when much of these data were generated. I think, I mean, that might be a good conversation for our Head of Research, Frank Parlati, to discuss further. But in terms of our clinical studies, again, it's not something we've looked at there in that context. So it's something we're very interested in and we certainly think given the relationship between both -- as you say, both glutamate and NRF2 pathway with ferroptosis and that this is potentially a very interesting mechanism, but not -- wasn't [Indecipherable] to the early data that we had put together preclinically at the time that we did that. It's really emerged over the last year or two. So I guess I would say to be determined, but certainly very interesting. And then in terms of CB-280, again, we'll let you know. I think our approach generally is to inform on if we are going to be reporting at a conference to do that once we have been accepted to that conference. So we will let you know, I guess, as that approaches.

Rob Andrew -- William Blair -- Analyst

Great. Thanks for taking the questions.

Keith Orford -- Chief Medical Officer

Yeah.

Operator

Thank you. [Operator Instructions] Next question from the line of Nick Abbott of Wells Fargo Securities. Your line is open.

Joe -- Wells Fargo Securities -- Analyst

Hi guys, it's Joe on for Nick. Congrats on the progress and appreciate you taking the question. Just a quick one from us. Apologies if I missed it, but have you provided an update on the NCI sponsored Tagrisso [Phonetic] combo study, the non-clinical [Phontic] trials, the primary completion date is second quarter of 2021. So should we be expecting data prior to the KEAPSAKE read-out or maybe how should we think about that?

Keith Orford -- Chief Medical Officer

Yeah. Thanks, Joe. For all of our sort of external studies that we don't sponsor including [Indecipherable] studies, it's hard for us to comment much on timing. So, no, we haven't released any data and it really wouldn't be our data to release, but those data have not been discussed publicly and to be honest, we don't have -- it's not like we're in constant communication and have total visibility of that. So that will be on NCI's timeline and I can't really speak to that right now, but as far as we know, these are moving along well and there are no issues, but we just don't have specific data to talk about today.

Joe -- Wells Fargo Securities -- Analyst

Yeah, no, understood, Keith. Appreciate it. Thank you for the comment there.

Keith Orford -- Chief Medical Officer

Yeah.

Operator

Okay, thank you. [Operator Instructions] There are no further question at this time. Please continue.

Susan M. Molineaux -- Founder, President & Chief Executive Officer

Okay, thank you. Thanks all for joining today and have a good evening.

Operator

[Operator Closing Remarks]

Duration: 18 minutes

Call participants:

Stephanie Wong -- Chief Financial Officer

Susan M. Molineaux -- Founder, President & Chief Executive Officer

Keith Orford -- Chief Medical Officer

James -- Citi -- Analyst

Rob Andrew -- William Blair -- Analyst

Joe -- Wells Fargo Securities -- Analyst

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