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spk01: Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Califero 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 the session, you will need to press star 1 1 on your telephone keypad. At this time, I would like to turn the conference over to Ms. Stephanie Wong. Ma'am, please begin.
spk02: Thank you, operator. Good afternoon, everyone, and welcome to our third quarter 2022 conference call. Joining me today are Susan Molino, founder, president, and CEO, and Emil Kariakos, 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 at califera.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 and Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements and as a result of various important factors, including those discussed in the risk factor section of our period clients 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.
spk03: Thanks, Stephanie. Good afternoon, everyone, and thank you for joining us for today's conference call. Last quarter, we announced the initiations and enrollment of the first patients in our Phase II clinical trials of Mivovotinib in relapsed refractory non-GCB diffuse large B-cell lymphoma, or DLDCL, and Sipanacertib in relapsed refractory Nrf2-mutated squamous non-small cell lung cancer. While 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 timelines. 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 Sipanacertib and Mivivotinib in their respective target patient populations and are committed to taking all steps possible to allow for their continued clinical development so that we can bring these therapies to patients. As we announced last month, Sipana Certib 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 the potential for priority review. We look forward to working with the agency as we continue to advance this 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. With that said, I will pass the call over to Emil to provide additional details on our program.
spk09: Thank you, Susan. Starting with our Cetanocertib program in September, we presented a trial-in-progress poster detailing the design of our Phase II clinical trial in relapsed refractory NRF2 or NFE2L2 mutated squamed non-small-cell lung cancer. As a reminder, the Cetanocertib study is an open-label monotherapy study in patients with non-small-cell lung cancer whose disease has progressed on or after platinum-double chemotherapy and immunotherapy. The study is evaluating two doses of saponocertib, two milligrams twice daily and three milligrams once daily, in patients with squamous non-small cell lung cancer harboring either wild-type or mutated NRF2 as detected by next-generation sequencing. The objectives of this study are to refine dosing and confirm saponocertib's selective activity in NRF2 mutant tumors compared to wild-type. The trial's primary endpoints are investigator-assessed overall response rate and safety, while secondary endpoints include duration of response, PFS, and OS. We believe that the data from this study could position Span Assertive for registration-enabling trials. We're excited to have received Fast-Track designation for Span Assertive. One of the advantages of Fast-Track designation is that it allows for earlier and more frequent communication with the FDA. We plan to utilize this benefit as we plan our next steps for the Span Assertive program, including a past potential registration. Now, turning to Mivivotinib, we are conducting a monotherapy study in patients with relapsed refractory non-GCB DL-BCL. We're planning to enroll approximately 50 patients with and without MITEI-88 or CD79B mutation. Patients are being randomized into one of two cohorts, continuous dosing at 100 milligrams Q daily, and an induction dosing schedule of 120 milligrams Q daily for 14 days, followed by 80 milligrams Q daily beginning on day 15. The objectives of the study are to confirm previously observed single-agent activity of Mivivotinib in these patients, determine activity in DLVCL patients harboring MITE88 and or CD79B mutations, and refine dosing and dosing in these patients. MITE88 CD79B mutation status is being determined using ctDNA-based liquid next-generation sequencing after randomization. The primary endpoints of the study are safety, overall response rates, as determined by 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 DLBCL, we 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 financials.
spk02: Thank you, Emil. As our financial results were included in today's press release, I will briefly review our results on this call. Our cash and cash equivalents totaled $34.1 million at September 30, 2022, which we expect will be sufficient to meet our current operating plan into the second quarter of 2023. As Susan mentioned, we are currently evaluating all options for our programs in order to extend our cash runway. R&D expenses for the third quarter of 2022 were $6.5 million compared to $11.6 million in the same period last year. The decrease was primarily related to decreases in the teleclinic set, CB280, and early-stage research programs partially offset by increases in the SAPAN Assertive and Mind Development 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 three months and at September 30, 2022, was $9.8 million. And with that, I will now return the call back over to Susan.
spk03: Thank you, Stephanie. And with that, operator, we are happy to open the line for questions.
spk01: Ladies and gentlemen, if you have a question or comment at this time, please press star 1 1 on your telephone keypad. Again, if you have a question or comment at this time, please press star 1 1 on your telephone keypad. Please stand by while we compile the Q&A roster.
spk05: Our first question or comment comes from the line of Roger Song from Jefferies.
spk01: Mr. Song, your line is open.
spk10: Great. Thank you for taking the question. Just a few quick ones from us. So the first one is maybe, Susan, you can elaborate on the enrollment and how confident you are you will have the data by next year and how to improve the enrollment given the environment. And also the follow-up question related to the timeline. Given you're considering all options for your pipeline and how much this partnership discussion will depending on the phase two data you're about to read out. Thank you.
spk03: Thanks, Roger. I can comment and then I will pass it along to Emil 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 Sipanacertib and Mivivotinib. We are experiencing site activation delays. We expect investigators, once they're open, to be enrolling patients on both of these trials. We believe in our drugs, and we believe that we are just up against some operational issues. at the clinical site, so we feel comfortable that we will have the initial clinical data by mid-2023. We do not need to have that Phase II 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 phase two initial data for both programs in mid-2023. Thank you.
spk10: Yeah, I'm not sure if Mo will have additional comments, but that's good.
spk09: Sorry, Roger, I was on mute. I didn't realize. Yeah, I mean, just I don't have much additional comments that Susan has said. I mean, essentially the main thing that happened over the last quarter was really activation delays in some of the sites owing to mostly, you know, several reasons, but including post-pandemic staffing shortages at several sites that's been recognized as a pretty widespread issue. And so several sites that were projected to activate in Q3 are actually activating this quarter, which is hence the reason for the delay in our But as Susan said, once these sites are up and running, we expect them to put patients on.
spk10: Got it. Okay. Great. And also, you do have some other earlier pipeline, maybe just summarize to us outside of those two clinical pipeline, what else, you know, pipeline and the particular for the EPS4 program. which is pretty promising, and what's the status for that program as well. Thank you.
spk03: The status of the VPS4 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 VPS4.
spk10: Got it. Thank you.
spk01: Thank you. Our next question or comment comes from the line of Swampakula Ramakant from H.C. Wainwright. Thank you. This is R.K. from H.C. Wainwright.
spk07: Good afternoon, Susan. Hi, R.K. So I understand. you know, from your commentary, you said, you know, do you have multiple options at hand to bring in? I'm guessing these are all non-diluted forms of cash. So to the extent you can, can you give us a flavor of, you know, what sort of things you're thinking of? From your commentary, at least, it looks like you want to keep... you know, you're not talking about the two clinical programs at this point. So does that mean VPS4 is in play in terms of, you know, in terms of relationship, the collaboration of some sort or even out licensing? Is that what we should understand?
spk03: 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 includes strategic collaborations or licensing agreements, and we are considering the sale of certain programs, but I can't give you more details than that at this time because we don't know.
spk07: Okay, fair enough. In terms of, you know, data coming up sometime in the first half of next year. How much data do you think you could have just in case you need to make an intelligent conversation about these two programs for the partnership situation?
spk03: I think that depends very much on the quality as well as the quantity of the data. As you know, these are open label programs. They're in specific genetically defined populations of cancer patients. And it is, you know, because it's open label, we can see the data. And we're looking for, you know, an 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 in now. And this is really safety and dose refinement and just trying to get confirmation that the data look the same as they did in prior studies. So I don't think there's a hard number you can put on it, but we would like confirmation for both these programs that, as we expect, the drugs have single agent activity in these specific populations.
spk07: Perfect. Thank you very much for taking my questions, Susan, and good luck and talk to you soon. Great. Thanks, RK.
spk01: Thank you. Our next question or comment comes from the line of Matthew Cowper from SVB Securities. Mr. Cowper, your line is now open.
spk08: Hey, guys. This is Matt Calperon for Jonathan Chang. Thanks for taking my call. Sorry, taking the question. It looks like if we hold OpEx flat for the next few quarters, you have runway into the third quarter of next year. I was just wondering if you could clarify what assumptions drive your runway guidance. Thank you.
spk02: Hi, Matt. It's Stephanie. You know, we don't typically disclose that level of detail. I can say we have considered various scenarios and various options. And so we're exploring all of them for all the programs and thinking about the right way to extend the cash runway.
spk04: Got it. Thanks.
spk05: Thank you.
spk01: Our next question or comment comes from the line of Aiden Husanoff from Leidenberg. Mr. Husanoff, your line is now open.
spk06: Hi, good afternoon, everyone. Thank you for taking my questions. I just wanted to elaborate on a couple of questions that were asked before. So about the delays in both studies, could you elaborate a little bit on these delays and just give us a better understanding whether these were unknowns in the beginning of the year? So how come we just know this just now? And these are not COVID-related delays, I assume, and could be staffing, but how come we didn't know this in the beginning of the year?
spk09: Yeah, I can answer that. Again, both of the, I mean, the delays were really unexpected in the sense of the various reasons that it occurred across different sites. The projections, you know, from both the site level and our level in terms of overall activation times were essentially progressing as planned. and some several sites had sort of unexpected delays due to various reasons that I guess most of the common reasons were staffing issues that, you know, essentially were unpredictable and known to be an issue that's still ongoing across the country. And so, you know, every site was different, but, again, it was something that hit us that got more realized around the last quarter in terms of their actual impact. on the studies. But again, the sites are activating. It's just that they were delayed by about a quarter in the majority of cases so that, you know, once they open up, we expect that the enrollment curve is going to get steeper.
spk06: Okay, got it. Thank you, Emil. And regarding the potential sale of one of the assets, could you tell us whether there is any sub-licensing fee if you... do the sub-licensing agreement to Takeda or Millennium or whatever company was responsible for this in-licensing, but you did it back in 2021.
spk02: Hi. We wouldn't comment on the specifics of that since it would depend on the way a transaction is structured, so it's difficult to interpret. I can say that the agreement is filed publicly with the SEC, and so it's available including all the conditions for something like a sublicense.
spk06: Okay. All right. And last question is... Would you consider sort of, you know, putting a pause on one of the trials in order to extend the cash runway if you don't find the suitable partner or collaborator?
spk02: We are evaluating all options for all our programs, and so can't say anything specific about them, but that would be something that we would consider in order to extend the cash runway.
spk06: Got it. Okay. Thank you very much.
spk01: Thank you. I'm sure no additional questions in the queue at this time. I'd like to turn the conference back over to Ms. Molyneux for any closing remarks.
spk03: Thank you, Operator, and thanks all for joining us today, and have a good evening.
spk01: Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.
spk04: The conference will begin shortly.
spk03: To raise your hand during Q&A, you can dial star 1 1.
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