This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk06: Good day, and thank you for standing by. Welcome to the Calicera Biosciences 2 Q21 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. And to ask a question during that time, you will need to press star 1 on your telephone keypad. If you require further assistance, please press star 0. I would like to hand the conference over to your speaker for today, Stephanie Wong. Please go ahead.
spk01: Thank you, operator. Good afternoon, everyone. Welcome to our second quarter 2021 conference call. Joining me today are Susan Molyneux, founder, president, and CEO, and Keith Orford, chief medical officer. Earlier this afternoon, we issued a press release which included an overview of our second quarter 2021 financial and operational results, which can be accessed through our website at calathera.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 Legation 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 factor 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'll turn the call over to Susan.
spk02: Thanks, Stephanie. Good afternoon, everyone, and thank you for joining us today on our second quarter 2021 conference call. In the second quarter, we continued to execute against our key strategic and operational objectives, which are focused on the advancement of our two lead programs, teloglenostat in non-small cell lung cancer and our oral arginase inhibitor, CB280, for the treatment of cystic fibrosis. The KEEP-SAFE trial, evaluating teloglenostat in combination with standard of care chemoimmunotherapy for first-line non-small cell lung cancer patients with KEEP1 or Nrf2 genetic mutations, continues to enroll, and we remain on track to report interim data in the fourth quarter of 2021. CB280 continues to enroll patients in our Phase 1B dose escalation study for the treatment of cystic fibrosis. As a reminder, we are conducting this study with support from the Cystic Fibrosis Foundation, including an award of up to $2.4 million for the clinical development of CB280. Looking beyond our two core programs, we signed a worldwide license agreement with Antigen for the development and commercialization of CB708, our internally discovered small molecule CB73 inhibitor. In preclinical data presented at AECR and CITSE in 2019, we demonstrated that CB708 has immune-mediated single-agent activity in syngeneic mouse models. and that it showed enhanced anti-tumor activity when combined with either an anti-PD-L1 or with chemotherapy. In exchange for the exclusive worldwide rights to develop CD708, we received from Antigen an upfront payment and are eligible to receive additional development, regulatory, and sales milestones, as well as tiered royalties on sales up to low double-budgets. We view the agreement with Antigen as an important validation of our proprietary drug discovery engine, as it demonstrates our ability to discover novel, highly promising therapeutic compounds. In addition, in June, we joined the Broad Institute's Cancer Dependency Map, or DEPMAP, consortium, an initiative whose goal is to discover new targets and biomarkers for precision cancer therapeutics. And we look forward to collaborating with them to drive precision medicine forward. We remain committed to delivering on our mission to bring to market novel therapeutics that address major unmet medical needs. We believe that the steps we've taken in the first half of 2021 position us well. We expect several important milestones to be achieved in the second half of the year and look forward to providing additional details as they are reached. And with that, I will pass the call over to Keith for additional details on our clinical program.
spk03: Thank you, Susan. I'll start by providing an update on telglenostat, our glutaminase inhibitor. As Susan mentioned earlier, we are currently enrolling the Keepsake Phase 2 study of telglenostat in non-small cell lung cancer patients harboring a KEEP1 or Nrf2 mutation. In the Keepsake trial, patients are randomized to receive telglenostat or placebo in combination with pembrolizumab, carboplatin, and pemetrexed. The study will evaluate the safety and investigator-assessed PFS of telglenostat plus the standard of care chemoimmunotherapy regimen. Enrollment in KEEP-SAFE began in September of 2020, and we remain on track to report interim data from the study in the fourth quarter of this year. The KEEP-1 Nrf2 mutations are present in an estimated 20% of all non-squamous, non-small-cell lung cases, representing approximately 40,000 patients in total. This is a significant market and an area of high unmet need, which we believe can potentially be addressed by Telglenostat. Our preclinical work with Telglenostat provides strong rationale, supporting the critical role glutaminase plays in the proliferation of KEEP1, Nrf2, non-small cell lung cancer tumors. We believe that Telglenostat has the potential to improve outcomes for these patients, and we look forward to further assessing its potential in the keepsake trial. Turning to CB280, our novel oral arginase inhibitor for the treatment of cystic fibrosis, the Phase 1b dose escalation study continues enrolling on schedule. As we reported previously, we plan to share data from this study in the second half of 2021, and I'm pleased to report that interim data from this study was recently accepted for presentation at the North American Cystic Fibrosis Conference taking place at the end of September, and we look forward to sharing these data with investors and members of the medical community at that time. We are also honored to be joining the Broad's DepMAP Consortium, through which we have an opportunity to generate novel data for our discovery programs and make better-informed decisions with respect to candidate advancement. Our interest in biomarker-driven approaches stems from the discovery of KEEP1 Nrf2 pathway dependency on glutaminase that drove the rationale for the KEEP-SAFE trial. We plan to utilize this partnership with the Broad to continue to explore biomarkers for teloglinostat, as well as identify biomarker-defined subpopulations of cancer patients for undisclosed pipeline programs. We look forward to partnering with the Broad to guide the development of our programs and the discovery of new ones. With that, I'll pass it over to Stephanie for an update on our financials.
spk01: Thank you, Keith. Detailed financial results for the current quarter were included in today's press release. I will briefly review our results in this call. Calis Air remains well capitalized with cash and investments totaling $92.2 million at June 30th, 2021. Revenue for the quarter was $3 million, reflecting revenue recognized from our licensing agreement with Antigene. R&D expenses were $12.8 million in the second quarter of 2021, compared to $15.6 million in the second quarter of 2020. The decrease was primarily driven by the decreases in teleclinic stat and 1158 programs, partially offset by increased expenses associated with our CB280 program, as well as investment in early stage research. T&A expenses were $4.5 million in the second quarter of 2021, compared to $5.1 million in the second quarter of 2020. The decrease was primarily related to decreases in professional services costs. and in rent expense related to our facility lease amendment in March of 2021. Net loss for the second quarter of 2021 was $14.3 million. And with that, I will now return the call over to Susan.
spk02: Thank you, Stephanie. And with that, operator, we're happy to open the line for questions.
spk06: Thank you, presenters. At this time, for the participants to ask a question, please press star 1 on your telephone keypad. We will pause for just a moment to compile the Q&A roster. And we have our first question from Matt Pipps from William Blair. Your line is open.
spk04: Hi, guys. Thanks for taking my question. Just maybe two quick ones for me. I was wondering if first you might just be able to comment on the Bayer acquisition of the Vidion this morning, obviously their lead program. believe also in kind of the keep one nerve to space, but maybe a different approach to that. Um, and then secondly, we talked a little around the abstract of the, uh, MD Anderson data with their glutamination embitter, but, um, just any thoughts after the actual presentation, it seemed like the greatest benefit they saw were in PD-1 resistant melanoma patients, but those patients actually didn't have, uh, some of the mutations they were looking for. So there's any comments on that. And I guess maybe how all these things, uh, reflect through the Keepsake program.
spk02: Oh, hi, Matt. This is Susan. I can comment on the Versidian acquisition by Bayer. They are obviously a preclinically-based company with a platform. They use their platform to develop both activators and inhibitors of NRF2, and they are clearly interested in taking inhibitors of NRF2 into the clinic in at least some population of Nrf2 keep mutants. It isn't completely clear to us exactly what that population would be because they are depending on their Nrf2 inhibitors to interact with keep and be degraded. But I think it's great. It's a, you know, a further validation of how important and interesting the keep Nrf pathway is. and approaches to developing Nrf2 inhibitors, you know, are certainly, you know, that would be new ground, and I think it's great that Davidian has made some progress. Obviously, we're way ahead. We're already in clinical trials for the glutaminase inhibitor, which does affect all of Keith's population.
spk03: Hey, Matt. This is Keith. I mean, in terms of the The clinical data, I may ask you to kind of clarify, but just generally speaking, you know, the data looked interesting. I think it's, you know, an active molecule. It has, you know, from a PK and PD perspective. I think from a safety profile, there may be some differences there from what we've seen with the teleclinic stat program. And, you know, we'll learn more as those data continue to come in. You know, I don't know from an efficacy perspective if there's, you know, given the size of the, you know, the sample size, if there's a lot to be gleaned. But was there, what was the specific question about the FCT data that you were asking?
spk04: Oh, I was just, I mean, commenting on those, to have the greatest clinical benefit in some PD-1 refractory melanoma patients, which, you know, you guys also showed some data there in your old study of the NEVO combo. But, you know, they said that those patients actually didn't have some of the mutations they were looking for, which was surprising that they were even enrolled in the study. But, yeah, just general comment on that.
spk03: Yeah, I do think that's interesting, and we think what we've seen is interesting in terms of the PD-1 refractory patients and, you know, continues to be an area of interest. So, yeah, I can't speak to why they didn't have the mutations that they were looking for, but... But, you know, the mechanisms of PD-1 resistance, you know, and we've talked about this before, that there is potentially a role for metabolism there and potentially specifically a glutamine metabolism. So I do think that's interesting.
spk04: Maybe just one last question. Can you give any idea now, as we get closer to this end of year readout, maybe how many patients we should expect for the keepsake interim?
spk03: Yeah, so, you know, so as we've talked about before, there isn't a specific statistically driven sort of event number or patient number that we're targeting for the interim. And so, you know, I don't have much more in terms of clarity in terms of specific numbers. I don't think we can speak to that at this point. So, you know, I think I'll leave it there.
spk04: Okay. Thanks, Keith.
spk03: Yeah.
spk06: once again for the participants to ask a question please press star 1 on your telephone keypad again that's star 1 on your telephone keypad we have our next question from from HTC Wainwright. Your line is open.
spk05: Thank you. Good afternoon, Susan and Kate. A couple of quick questions. On the keepsake trial, you know, the interim data, which is expected in the fourth quarter, you know, would this be a press release or would this be, you know, at a conference? And what sort of data are should we be expecting at the interim look?
spk03: Yeah, so in terms of the format or the forum, you know, we're not planning to, you know, present at a meeting at that time. So it will be some, you know, some other format. And in terms of the type of data, you know, we've talked about this some before. The types of things that we'll be looking at are generally response rate and PFS and comparing against, you know, the known historical data for this population, which, as you know, is quite poor, medium PFS in the three- to five-month range. So, you know, so that's really what we'll be focused on.
spk05: Okay, thanks. And then just trying to understand the cystic fibrosis franchise, you know, with the interim data again expected, you know, soon at the end of September. So is there, you know, what is the expectation on the timing for completion of this trial? And, you know, what would be the next, steps in this, you know, for this molecule in your hands, or do you think that, you know, just to move to the next level, you need to have a partnership?
spk03: Thanks, RK. So, the CF program, you know, the study is an ongoing study, so we'll be presenting data from the ongoing dose escalation. We expect that study to be completed this year. And in terms of next steps, what we have discussed previously is that this is, what would follow would be a dose ranging study across a few different dose levels to be determined based on the data that come out of the dose escalation. but with the goal of having FEV1 as a primary endpoint and to select a dose for further development. And I think it's – I wouldn't say that a partnership is required at all to move forward to that next phase of development.
spk05: Okay. And then last question from me is just to think about, you know, long-term pipeline, you know, with CB708. under, you know, which just underwent license agreement. You know, Susan, how should we think about, like, you know, pipeline growth from here onwards? You know, is there something in the preclinical development and should we be expecting another molecule come to the forefront maybe in the next 12 to 18 months?
spk02: That's a good question. We haven't talked lately about our preclinical pipeline, but I will say that our research group remains quite active. I will point to the fact that we just joined the Broad Institute. I think that reflects our increasing interest in biomarker-driven studies approaches such as we're taking in the KEEP-SAFE trial, and that will be our area of interest most likely going forward. We like the idea of being able to find genetic mutations in specific populations where a particular drug could be targeted, and that, of course, is the case for glutaminase in the NERF KEEP pathway mutants in lung cancer. So, you know, we aren't in a position to say anything now, but our research group is active, and I would fully expect preclinical programs in the future to come out in oncology and in the very general area of biomarker-driven approaches to target validation and making inhibitors of targets.
spk05: Perfect. Thank you. Thank you for taking all my questions.
spk03: You're welcome.
spk05: Thanks, everybody.
spk06: And there are no further questions at this time. I will hand the call over back to the presenters.
spk02: Thank you, operator, and thanks all for joining us today, and have a good evening.
spk06: Ladies and gentlemen, this concludes today's presentation. Thank you for participating. You may now disconnect.
Disclaimer