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Calithera Biosciences Inc (NASDAQ:CALA)
Q3 2020 Earnings Call
Nov 5, 2020, 5:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Thank you for standing by. And welcome to the Calithera Biosciences, Q3 2020 earnings call [Operator Instructions]

I would now like to hand the conference over to your speaker, Jennifer McNealey. Please go ahead.

Jennifer McNealey -- Vice President of Investor Relations and Strategy

Thank you, Jenny. Good afternoon, everyone. Welcome to our third quarter 2020 conference call. Joining me today are Susan Molineaux, our founder president and CEO Keith Orford, Chief Medical Officer and Stephanie Wong, Senior Vice President of Finance. We have issued our press release and it 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 in the risk factors discussed in the risk factors section of our quarterly report on form 10 q filed with 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, please, we specifically disclaim any obligation to do so even if our views change. [Operator Instructions]

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

Susan M. Molineaux, Ph.D. -- Founder, President and Chief Executive Officer

Thanks, Jennifer. Good afternoon, everyone. And thank you for joining us today on our third quarter 2020 conference call. On behalf of the entire team, I'd like to say we hope that you and your friends and family remain healthy. While the world address this new challenges including the covid 19 pandemic. we've adapted as a company to the new normal work environment, and we are prepared to maintain working from home for most of our employees into the coming month. At the same time, we've successfully reopened our lab and have been able to maintain a safe and productive environment. So 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 at work while balancing it with all the personal challenges that COVID-19 brings. We are both appreciative and proud of our entire team.

Today 2020 has been a significant year for kalutara. As we make remarkable progress to advance our clinical development efforts across our pipeline, and work toward reporting our first civil trial results with our lead candidate glutaminase inhibitor tells them step while continuing to strengthen our cash position. At calcaterra. We are building an integrated biotechnology company that develops novel small molecule uncom, metabolism drug, drug fidra, targeting tumor and immune cell metabolism pathways to 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 development programs toward commercialization.

We are the first company to take a selective glutaminase inhibitor into the clinic and the first to demonstrate clinical activity in cancer patients, including proof of concept the activity of telecon is set in renal cell carcinoma in our randomized and treasa trial contacta a trial with registration potential in renal cell carcinoma patients. It's fully enrolled with top line data expected in late fourth quarter 2020 or early first quarter 2021. This moves us a step closer to becoming a commercial biotechnology company and we are focused on laying out the infrastructure and plans needed for a successful future. We are developing telecom step broadly and have initiated the randomized keepsake trial in first line non small cell lung cancer patients harboring genetic mutations and keep one or two study sites are now open for enrollment in the keepsake trial and we enrolled our first patient in September.

We also continue to evaluate valuate till Glenda stat in multiple indications and this week announced an expansion of our telegram istep grants combination trial. We're pleased to be working with Pfizer as part of this productive clinical collaboration. Our partners, our genetics inhibitor program is ongoing with insight, where we have a number of clinical trials evaluating 1158 for the treatment of cancer. While we remain committed to unconfident in the 1138 development program, we have decided to opt out of our code development obligations at this time effective September 30, as permitted under the terms of the inside agreement, And in order to focus our resources on our own internal development program arginase inhibitors also have potential in the treatment of cystic fibrosis.

Accordingly, we selected TB to add a unique oral arginase inhibitor to the treatment of this patient population. Earlier this week, we announced that we were awarded up to $2.4 million from the Cystic Fibrosis Foundation to support clinical development of Cb 280. We are grateful to the Cystic Fibrosis Foundation for their support, and we're very 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.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Thank you, Susan. Let's begin with a more detailed update on tell Glenna step our glutaminase inhibitor in late stage clinical trials. We are currently focused on forging a clinical and potentially commercial path for child wellness that in renal cell carcinoma, and look forward to results of the first randomized trial of Turkmenistan with registration potential. top line results of the contado trial are anticipated in late fourth quarter of 2020 or early first quarter of 2021. cantata is a global randomized double blind trial of total blindness that in combination with cabozantinib in second and third line RCC patients, and tada enrolled 444 patients ahead of schedule demonstrating the significant unmet need for advanced RCC patients in the second and third line setting. cantata is designed to evaluate the efficacy and safety of tell when a stat in combination with CAD advancing it versus placebo pose Kevin Xanthan and clear cell RCC patients who have previously received one or two prior lines of therapy, including at least one prior anti angiogenic agent or ipilimumab, now volume and combination.

Patients were randomized in a one to one ratio to either tell Blender staff plus cabas Anthonis or placebo plus cabas answer them. Patients were stratified by MDC risk category and prior treatment with anti PD one PDL one therapy, the primary endpoint is progression free survival by independent review. overall survival will be assessed as a key secondary endpoint. Our team is working diligently to make all the necessary steps to take all the necessary steps to complete the study, and we look forward to sharing the results with you. We previously reported the results of our entrata trial, a randomized double blind trial designed to evaluate the safety and efficacy of children is that in combination with ever aloneness versus placebo with everolimus in patients with advanced clear cell RCC, the trial enrolled 69 patients, the primary endpoint was PFS per investigator assessment with a predetermine threshold of P less than 0.2 one sided. top line results were reported in June 2019.

Top one stat when added to everolimus, double the median PFS and heavily pretreated patients with advanced RCC to 3.8 months as compared to 1.9 months for everyone This alone and reduce the risk of disease progression or death by 36%. The hazard ratio was 0.64 with a one sided p value of 0.079. Although the study was not powered for survival, it was evaluated as a secondary endpoints and is now mature enough to be reported. based on the data cut off of September 30 2020, the median overall survival is 14.4 months versus 9.7 months in the tail better stat and control arms respectively, with the hazard ratio of 0.80 and a one sided p value of 0.24. To put this data in context, this was a small single seeking phase two study, it was meant to look for a trend toward improved PFS and was not powered for overall survival.

Given the small size of the trial, we recognize the limitations of the data but are pleased with the trends observed in this advanced patient population. We also believe Tobin's that has the potential to be developed in patients with keep one nerf two mutations. mutations in the keep one nerve to pathway, which occurred an estimated 20% of non small cell lung cancer patients are associated with aggressive tumor growth. recently presented clinical data demonstrated that activation of this pathway, either through the loss of keep one function or activation of nerve two are associated with poor clinical outcomes among patients with non small cell lung cancer receiving frontline standard of care, chemo immunotherapy.

Preclinical models have shown that activation of the keep one nerve to pathway makes sense dependant on glutaminase activity for growth and survival, making these tumors exquisitely sensitive to inhibition of recombination activity by telling us that the double blind till once that trial notice keepsake enrolled the first patient in September 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 the keep one or two mutation. Patients will be randomized to receive tau one stat or placebo in combination with Pember lism ab carboplatin and pemetrexed said the study will evaluate the safety and investigator assess the PFS of toggling of staff plus the standard of care chemo immunotherapy regimen. We plan to share interim data from this study in 2021.

We're also conducting an exploratory phase one B two trial in collaboration with Pfizer, combining television a spat with IBM, we are pleased to announce the expansion of that collaboration to evaluate the combination in pancreatic cancer patients. The initial combination trial evaluated the combination in patients with solid tumors, including expansion cohorts and K wrasse mutated colorectal cancer and K wrasse mutated non small cell lung cancer. Encouraging efficacy and safety of the combination was observed was observed in p DAC patients, pancreatic ductal adenocarcinoma patients treated in the dose escalation phase of the trial leading to the expansion cohort. The new cohort of the phase one two trial clinical trial will be evaluating the safety and anti tumor activity of test one stat in combination with pelvic cyclin in patients with advanced metastatic t Dec, whose tumors harboring mutations in both k Ras and cDk and two A.

So once that blocks glutamine consumption in tumor cells, which due to specific genetic alterations, such as mutations in K Ras, and cDk nta, often become dependent on increased metabolism of glutamine. Approximately 50% of feedback patients harbor mutations in both k Ras and cDk and tra in preclinical studies with K wrasse mutated cancer models. television set shows synergistic anti tumor effects when used in combination with cDk four six inhibitors, such as pebble cyclin, enhancing cell cycle arrest and blocking cancer cell proliferation. Recently, we announced the initiation of the first clinical trial to evaluate our novel argenis inhibitor in cystic fibrosis, and we are pleased with the enrollment to date. The depletion of arginine and cystic fibrosis patients by the enzyme arginase results in reduced production of nitric oxide, a key antimicrobial and bronchodilator.

Therefore arginase inhibitors have potential in the treatment of cystic fibrosis. And we have selected CB two ad, a unique oral arginase inhibitors solely owned by Caldera for the treatment of cystic fibrosis. In October, we presented a trial and progress poster describing the trial design at the North American cystic fibrosis conference. The presentation included preclinical study results, which suggested CBT at significantly improved lung function and reduced Pseudomonas Aeruginosa colony forming units in preclinical models. arginase inhibition with CBT radio resulted in improved central airway resistance and cftr knockout mice and decreased lung infection in wildlife and delta five and eight cftr expressing mice infected with Pseudomonas Aeruginosa.

We've also identified Cb 668 and investigational first in class potent orally administered IO four I one inhibitor as a novel and you know oncology approach to cancer. cb 668 is an inhibitor of the enzyme aisle four I one, an enzyme that is expressed by tumor cells and antigen presenting cells, metabolizes phenylalanine, tyrosine and tryptophan to produce hydrogen peroxide, an inhibitor of T cell function. In particular, I offer I one can metabolize trip to fan to kinase tiny ringgit acid, and other metabolites that lead to immunosuppression in the tumor microenvironment. I O for I want expression has been correlated with poor outcomes in several tumor types as a potential role and invasion in immune invasion, and may decrease the ability of checkpoint therapy to stimulate an anti tumor immune response. I offer I want to expression is elevated in multiple tumor types, with particularly high expression in ovarian and B cell tumors. New preclinical data for CVD 668 will be presented next week at the Society for immunotherapy of cancer virtual meeting.

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

Stephanie Wong -- Senior Vice President of Finance and Secretary

Thank you, Keith. And good afternoon everyone. Detailed financial results for the third quarter 2020 were included in today's press release. I will briefly review our results on this call. telecare remains well capitalized or cash cash equivalents and investments were 137.7 million at September 30 2020. r&d expenses were 18.2 million for the quarter ended September 30 2020. Compared to 17.2 million for the same period prior year. The increase was primarily due to increases in the telecom staff and GBT programs partially offset by decreases in the 1158 program and early stage research.

Expenses were 4.7 million for the quarter ended September 30 2020. Compared with 3.9 million for the same prior year, be increased, which primarily related to hire personnel related and facility costs. interest and other income net was 0.2 million for the quarter ended September 30 2020, compared to 0.8 million for the same period prior year. Mainly As a result, the lower interest rates, net loss for the quarter ended September 30 2020 was 22.7 million or 32 cents per share.

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

Susan M. Molineaux, Ph.D. -- Founder, President and Chief Executive Officer

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

Questions and Answers:

Operator

[Operator Instructions] The first question is from Jonathan Chang, with SVB Leerink.

David Rhew -- SVB Leerink -- Analyst

Hey, guys, this is David Rhew. Shawn for Jonathan. Thanks for taking our questions. First question just on the iPads combo in pancreatic cancer that you announced yesterday, the press release mentioned there were some encouraging advocacy signals in feedback patients. I was just wondering if you could elaborate on any of the clinical data points you've seen and reasons for confidence in the in the combination?

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Yeah, so we, we enrolled patients across a number of tumor types during the dose escalation. And based on activity that we saw there. We saw that we were encouraged enough and as was Pfizer to to open a cohort. So it's not a position to give more information, I think than that, but that was the basis of the decision.

David Rhew -- SVB Leerink -- Analyst

Okay, great. And then could you just provide, is there anything else you can provide on the cantata timing and the impact of COVID-19 on the data aggregation? I guess, have you have you seen anything from your trial sites? That gives you further confidence in the timeline that you've reiterated today?

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Yeah, so, you know, as we've talked about previously, COVID has had some impact. And it's largely around the ability to do what's called source data verification and rich requires our CRA s to get on site and look at the data, particularly in Europe. Yeah, it's, you know, this has been a process now that we've been working on for four months and have been able to, you know, I think accomplish a lot and address some of those issues. And as we've been seeing the data, you know, gets cleaned in, we are, you know, increasingly confident in our timeline. So, you know, based on what we've seen over the last several months, we remain confident in that timeline.

David Rhew -- SVB Leerink -- Analyst

Great, thanks a lot and congrats on the progress.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Yeah, thank you.

Operator

Next question is from Arthur He with H.C. Wainwright.

Arthur He -- H.C. Wainwright -- Analyst

My question is also for our key, I just want to follow up on the ad guarding the the pancreatic cancer trials. So just remind us to have you guys decide which is the pre cancer trial. So just remind us to have you guys decide which is the the recommended dose level for the expansion cohort.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Yes, we will. So you know, as with all of our combinations Terminus that has been well tolerated and so we've been able to do set of photos in combination with with iPhones.

Arthur He -- H.C. Wainwright -- Analyst

Yes, we will. So you know, as with all of our combinations Terminus that has been well tolerated and so we've been able to do set of photos in combination with with iPhones.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Correct

Arthur He -- H.C. Wainwright -- Analyst

Okay. And just a quick follow up. So could you able to elaborate on how large would be the expansion cohort size?

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

So, you know, this study is what are designed similar to other studies that we've designed in terms of expansion cohorts. Actually, the the, the pancreatic study is in the process, the protocol amendments in the process of being being finalized. So, so no comments on that specifically, but it wouldn't be dissimilar to other other cohorts that we have designed.

Arthur He -- H.C. Wainwright -- Analyst

I see it just a quick one. So for the pancreatic cancer patient, maybe. So is there any requirement for the prior treatment number, or no, or the EOB, all combined into this extension code.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Given that this is an experimental therapy, it's a combination of two therapies that aren't approved, there will be a requirement to have received a prior, you know, standard of care therapy. Again, some of those details will be finalized in the the amendment but, but the patients will, you know, be expected to receive the standard of care therapy for advanced disease.

Arthur He -- H.C. Wainwright -- Analyst

Okay, thank you. Thank you for that.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Yeah, sure.

Operator

The next question is from Matt Phipps with William Blair.

Matt Phipps -- William Blair -- Analyst

Hey, good afternoon. Thanks for taking my question. Um, you know, it's actually really I'm happy to see the try to try to survival trends and discourage that there have been any kind of regulatory discussions around them kind of wanting to see a positive trend, at least in overall survival. I know PFS is an approval endpoint at RCC, but there has been one particular tikai that said some issues but whether or not this altos should survival term.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Yes. So so we're talking about the Cabo combination. Now for cantata. I see a man, by the way. So yeah, so yeah, so we have and I think we've talked about in the past, when we've been we've discussed with FDA as well as European regulators. And while while the primary endpoint is PFS, you know, there, they will look at the totality the the data, and there is, you know, some expectation of OS, you know, at least trending in the in the right direction.

Matt Phipps -- William Blair -- Analyst

Great, thank, you know, following now, we've actually seen the checkmate 90 our data. How do you guys think that impact? I guess, really, the question is, do you think a doctor would use this combination? If someone had already seeing Cabo with P one? Or, you know, I think there's still plenty of market share, even if it's just for me, a lot of people use other TK refractory. But I just kind of thought about that a little.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

You know, it's, it's hard to comment on what, what someone might do. I think, from the perspective of our study design, we, you know, these patients were cavo naive. And so we certainly would expect that to be the label. You know, I we think the data look really good for the 90 our data for the nine year study. And what we've heard is, you know, it fits right in there with other therapies that are approved in the in the frontline. So, you know, presumably, there'll be some uptake. And, you know, it wasn't, it was not by any means a surprise that this study would be positive. Kava is a great drug. And, you know, we we certainly expected that would be positive compared to soon in. And but as you say, you know, given the, you know, the options available in front line, we certainly would expect, you know, a significant number of patients to come to second line having not seen Cabo. Yeah.

Matt Phipps -- William Blair -- Analyst

Yep. Great. All right. Thanks for the question.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Yeah, thanks.

Operator

Last question is from Mohit Bansal, with Citi.

James -- Citi -- Analyst

This is James [Phonetic] on for Mohit. So just a quick one. In regards to keys take enrollment, can you share how many patients have been involved since the first patient back in September? And given that COVID seems to be spiking in some regions, then chances are you seeing any slowdown in enrollment.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Yeah, so I can't speak to the specific number I can say that it's you know, it's more than one here we certainly enrolled, you know, multiple patients and since that patient enrolled, it you know, given as is typical, but with all studies as eropa And we're in the process of getting our sites open and so forth. But we're happy with what we're seeing in terms of enrollments so far in terms of the impact of COVID. You know, we're not seeing anything at this point. We're not aware of specific issues, actually, I think, from you know, in Europe there they're in this isn't keepsake is only open in the United States. We have seen, you know, sites closing down more so in Europe, but in the US, I'm not aware of sites that have been having issues from this current spike in COVID. But certainly, we have our eyes open and we're talking to our sights and and we'll see how that plays out. But to date, no impact that we're aware of.

James -- Citi -- Analyst

That's it, appreciate it.

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Yes. Thanks, James.

Operator

There are no further questions, our national colleagues over back to Jennifer McNealey.

Jennifer McNealey -- Vice President of Investor Relations and Strategy

Thank you, Tony. And Thanks all for joining us today. Have a great evening.

Operator

[Operator Closing Remarks]

Duration: 26 minutes

Call participants:

Jennifer McNealey -- Vice President of Investor Relations and Strategy

Susan M. Molineaux, Ph.D. -- Founder, President and Chief Executive Officer

Keith Orford, M.D., Ph.D. -- Chief Medical Officer

Stephanie Wong -- Senior Vice President of Finance and Secretary

David Rhew -- SVB Leerink -- Analyst

Arthur He -- H.C. Wainwright -- Analyst

Matt Phipps -- William Blair -- Analyst

James -- Citi -- Analyst

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