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spk05: and CDKN2A. Telglenostat blocks glutamine consumption in tumor cells, which, due to specific genetic alterations, such as mutations in KRAS and CDKN2A, often become dependent on increased metabolism of glutamine. Approximately 50% of PDAC patients harbor mutations in both KRAS and CDKN2A. In preclinical studies with KRAS-mutated cancer models, Teleplanistat showed synergistic anti-tumor effects when used in combination with CDK4-6 inhibitors, such as Palvocyclib, enhancing cell cycle arrest and blocking cancer cell proliferation. Recently, we announced the initiation of the first clinical trial to evaluate our novel arginase inhibitor in cystic fibrosis, and we are pleased with the enrollment to date. The depletion of arginine in 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 CB280, a unique oral arginase inhibitor solely owned by Calthera for the treatment of cystic fibrosis. In October, we presented a trial in progress poster describing the trial design at the North American Cystic Fibrosis Conference. The presentation included preclinical study results which suggested CB280 significantly improved lung function and reduced Pseudomonas aeruginosa colony-forming units in preclinical models. Arginase inhibition with CB280 resulted in improved central airway resistance in CFTR knockout mice and decreased lung infection in wild-type and Delta 508 CFTR-expressing mice infected with Pseudomonas aeruginosa. We have also identified CB668, an investigational first-in-class potent orally administered IL-4I1 inhibitor as a novel immuno-oncology approach to cancer. CB668 is an inhibitor of the enzyme IL-4I1, 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, IL-4i1 can metabolize tryptophan to kynurenic acid and other metabolites that lead to immunosuppression in the tumor microenvironment. IL-4i1 expression has been correlated with poor outcomes in several tumor types, has a potential role in immune invasion, and may decrease the ability of checkpoint therapy to stimulate an anti-tumor immune response. IL-4i1 expression is elevated in multiple tumor types with particularly high expression in ovarian and B-cell tumors. New preclinical data for CB668 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.
spk01: 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. Califera remains well capitalized. Our cash, cash equivalents, and investments were $137.7 million at September 30, 2020. R&D expenses were $18.2 million for the quarter end of September 30, 2020, compared to $17.2 million for the same period prior year. The increase was primarily due to increases in the teleglinostat and CB280 programs, partially offset by decreases in the 1158 program and early stage research. G&A expenses were $4.7 million for the quarter end of September 30, 2020, compared with $3.9 million for the same prior year. The increase was primarily related to higher 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 of 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 return the call back over to Susan. Thank you, Stephanie. And with that, operator, we are happy to open the line for questions.
spk02: Again, if you have a question, press star 1 on your telephone keypad. Your first question is from Jonathan Chang with SVB Lyric.
spk04: Hey, guys. This is David Ruchon for Jonathan. Thanks for taking our questions. First question, just on the iBrands combo in pancreatic cancer that you announced yesterday, the press release mentioned there were some encouraging efficacy signals in PDAC 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 PDAC combination.
spk05: Yeah, so we enrolled patients across a number of tumor types during the dose escalation, and based on activity that we saw there, we were encouraged enough, and as was Pfizer, to open a cohort. So I'm not in a position to really give more information, I think, than that, but That was the basis of the decision.
spk04: 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 seen anything from your trial sites that gives you further confidence in the timeline that you've reiterated today?
spk05: Yeah, so 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, which requires our CRAs to get on site and look at the data, particularly in Europe. This has been a process now that we've been working on for months and have been able to I think, accomplish a lot and address some of those issues. And as we've been seeing the data, you know, get cleaned, 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.
spk04: Great. Thanks a lot, and congrats on the progress.
spk05: Yeah, thank you.
spk02: The next question is from Arthur He with AHC Wainwright.
spk06: My question is also for Aki. I just want to follow up on the regarding the pancreatic cancer trial. So just remind us, have you guys decided which is the pancreatic cancer trial? Just to remind us, have you guys decided which is the recommended dose level for the expansion cohort?
spk05: Yes, so as with all of our combinations, Telguanacet has been well-tolerated, and so we've been able to dose at full dose in combination with iBrands.
spk06: So is that 800 plus 125 milligrams? That will be applied to all three expansion cohorts?
spk05: Correct.
spk06: Okay. And just a quick follow-up, so could you be able to elaborate how large would be the expansion cohort size?
spk05: So the studies are designed similar to other studies that we've designed in terms of expansion cohorts. Actually, the pancreatic study is in the process, the protocol amendment's in the process of being finalized. So no comments on that specifically, but it wouldn't be dissimilar to other cohorts that we have designed.
spk06: I see. And just a quick one. So for the pancreatic cancer patient, So, is there any requirement for the prior treatment number or no? Or they would be all coming into this extension cohort?
spk05: You know, 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 amendment. But patients will, you know, be expected to have received a standard of care therapy for advanced, you know, disease.
spk06: Okay, thank you. Thank you for that.
spk05: Yeah, sure.
spk02: Our next question is from Matt Nipps with William Blair.
spk07: Hey, good afternoon. Thanks for taking my question. You know, I was actually really Happy to see and try to survival trends. And just curious, has there 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 approvable endpoint in RCC, but there has been one particular TKI that's had some issues, but whether or not they also should survival trends. Okay.
spk05: Yes, so you're talking about the Cabo combination now for Cantata, I assume. Hey, Matt, by the way. So, yeah, so we have, and I think we've talked about that in the past, when we've been, you know, we've discussed with FDA as well as European regulators, and while the primary endpoint is PFS, you know, they will look at the totality of the data, and there is, you know, some expectation of OS performance. you know, at least trending in the right direction.
spk07: Great, thanks. And, you know, following that, we've actually seen the Checkmate 90R data. How do you guys think that impacts? I guess really the question is, do you think a doctor would use, you know, this combination if someone had already seen CABA with P1 or, you know, I think there's still plenty of market share even if it's just for, you know, a lot of people, your oil factory or any other TKR factory. But I'm just curious if you've kind of thought about that at all?
spk05: You know, it's hard to comment on 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, we think the data looked really good for the 9ER data, for the 9ER study, and what we've heard is You know, it fits right in there with other therapies that are approved in the front line. So, you know, presumably there will be some uptake. And, you know, it wasn't, it was not by any means a surprise that the study would be positive. Cabo is a great drug. And, you know, we certainly expected that to be positive compared to sunitinib. And, but as you say, you know, given the, you know, the options available in front line, we certainly would expect a significant number of patients to come to second line having not seen CAVO yet.
spk07: Yep, great. All right, thanks for answering my question.
spk05: Yep, thanks, Matt.
spk02: The last question is from Mohit Bansal with Citi.
spk03: This is James on for Mohit. Just a quick one. In regards to keystake enrollment, can you share how many patients have been enrolled since the first patient back in September? And Given that COVID seems to be spiking in certain regions, is there any chance, are you seeing any slowdown in enrollment?
spk05: Yeah, so I can't speak to the specific number. I can say that it's, you know, it's more than one. We've certainly enrolled, you know, multiple patients since that patient enrolled. You know, given, as is typical with all studies as they're opening, 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 enrollment 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, and 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 U.S., 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 sites and we'll see how that plays out. But to date, no impact that we're aware of.
spk03: Thank you. Appreciate it.
spk05: Yeah. Thanks, James.
spk02: There are no further questions. I will now turn the call over back to Jennifer McNeely.
spk01: Thank you, Tony. And thanks all for joining us today. Have a great evening.
spk02: That concludes today's conference. You may now disconnect. you Bye. music music you
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