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spk07: Greetings and welcome to CEL QED First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Robert Ewell, with ICR last week. Please go ahead.
spk04: Thank you, Operator, and good afternoon to everyone on the call. Thank you for joining us to review Salcuity's first quarter 2023 financial results and business update. Earlier today, Salcuity released financial results for the first quarter ending March 31, 2023. The press release can be found on the Investors section of the website. Joining me on the call today are Brian Sullivan, Salcuity's Chief Executive Officer and Co-Founder, Vicki Hahn, Chief Financial Officer, as well as Igor Gorbachevsky, Chief Medical Officer, who will be available during Q&A. Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward-looking statements. Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. On this call, we will also refer to non-GAAP financial measures. These non-GAAP measures are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance. Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press release. With that, I would now like to turn the call over to Brian Sullivan, CEO of CellCuity. Please go ahead, sir.
spk02: Thank you, Robert, and good afternoon, everyone. Since we provided a corporate update just seven weeks ago during our full year of 2022 financial call, I'll only make brief prepared remarks today. I'm very pleased with the execution to date of our Victoria I Phase III clinical trial enrollment activities at our trial sites. As we've reported previously, Victoria I is evaluating Geta-Tolicit in combination with Fulvestrin with and without polycycline in adults with HR-positive or 2-negative advanced breast cancer whose disease progressed while receiving a CDK4-6 inhibitor. Our team is relentlessly focused in keeping us on track to report the primary analysis for the PIK3CA non-mutated patient subgroup in the second half of 2024 and the primary analysis for the PIK3CA mutated patient subgroup in the first half of 2025. This is consistent with our prior guidance. At the Asthma and Breast Cancer Congress last week, We presented updated median progression-free survival data for treatment-naive HR-positive for two negative advanced breast cancer patients. We think the data is very encouraging. In our poster presentation, we provided updated efficacy and safety data in treatment-naive patients who are enrolled in Escalation Arm A and Expansion Arm A of our Phase 1b study. We had previously reported data for this group of patients at the San Antonio Breast Cancer Symposium last December. a cutoff date of June 29, 2022, but the median PFS and expansion RMA had not yet been reached. As of a March 16, 2023 data cutoff date, with the benefit of the additional follow-up period, we were able to report final median progression-free survival and median duration of response data for these patients. For treatment-naive patients in escalation RMA, median progression-free survival was 45.8 months, and for patients in expansion RMA, It was 48.6 months. When the results for treatment-naive patients from each of these arms are analyzed together, median progression-free survival was 48.6 months, and median duration of response was 46.9 months. These results compare very favorably to the median PSS of 24.5 months reported in the PILOMA3 study for polycyclic plus letrozole. We think these results demonstrate the intrinsic role the PI3K mTOR pathway plays as a disease driver in advanced HR-positive HER2-negative breast cancer. The data also highlight the potential opportunity to develop getathelizib as a first-line treatment option. We continue to characterize getathelizib's activity in various tumor types and compare its activity to other drugs in the class. As we've previously reported, the non-clinical studies we presented at ASCO-GU in February for prostate cancer and at AACR in April for gynecological cancers highlighted get it elicit differentiation from other drugs in this class. In each of the studies we performed, in all of the tumor types assessed, get it elicit demonstrated superior therapeutic effect relative to the other PI3K, AKT, and mTOR inhibitors evaluated. Based on the results from these internal nonclinical studies, as well as published reports of prior clinical results with drugs in this class, We think there is a significant opportunity for us to develop Geta-Felicib in these tumor types. We'll provide an update on our clinical development priorities later this year. And finally, the FACT-1 and FACT-2 trials are continuing to enroll patients with early-stage HR-positive HER2-negative breast cancer whose HER2 pathway is hyperactive, as detected with our CYGNIA test. We now expect to announce interim results from these studies in the first half of 2024. And with that, I'll now turn the call over to Vicki Hahn, to review our financial results.
spk03: Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our first quarter 2023 financial results. The first quarter net loss was $11.9 million or $0.55 loss per share compared to a net loss of $7.9 million or $0.53 loss per share for the first quarter of 2022. Because these quarterly net losses include significant non-cash items, including stock-based compensation and interest expense, we also include in our press release non-GAAP adjusted net loss for the quarter ending March 31, 2023. Our non-GAAP adjusted net loss for the first quarter of 2023 was $10.2 million, or $0.47 loss per share, compared to non-GAAP adjusted net loss for the first quarter of 2022, of $7 million or $0.47 loss per share. Research and development expenses were $11.3 million for the first quarter of 2023 compared to $6.7 million for the first quarter of 2022. The approximately $4.6 million increase resulted primarily from cost supporting activities related to the Victoria I pivotal trial. General and administrative expenses were $1.3 million for the first quarter of 2023, compared to $0.8 million for the first quarter of 2022. The approximately $0.5 million increase was a result of non-cash stock-based compensation and professional fees associated with being a public company. Net cash used in operating activities for the first quarter of 2023 was $12.9 million, compared to 5.9 million for the first quarter of 2022. This was the result of non-GAAP adjusted net loss of 10.2 million, working capital changes of approximately a million, and non-cash interest income of approximately 1.7 million. We ended the quarter with approximately 157.5 million of cash, cash equivalents, and short-term investments, compared to $168.6 million at December 31st, 2022. With that, I will now hand the call back to Brian.
spk02: Thank you, Vicki. Operator, could you please open the call for questions?
spk07: Sure. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your knowledge in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your headset before pressing the star keys. One moment, please, while we pull for questions.
spk05: Our first question comes from Maury Raycroft with Jefferies.
spk07: Please go ahead.
spk01: Hi, congrats on the progress and thanks for taking my questions. I was wondering, as it relates to the preclinical data that you presented at ASCO-GU and the AACR data and the positive ESMO breast cancer frontline PFS data, can you talk more about what gating factors are to inform your next steps with development later this year? I guess what would go into those decisions, and would it be based on the Phase III progress?
spk02: Sure. So we've been somewhat independently evaluating the landscape of opportunities to consider for development of Geta-Felicit. And so Parallel R&D Group has done a great job of reporting, developing the data, conducting the studies for the data that we presented at ASCO and AACR. And that helps inform our decisions. Simultaneously, we've been doing a review of prior published data for clinical trials evaluating inhibitors in this class. And then we've also evaluated the market opportunity, standard of care treatment, the unmet need, essentially doing a holistic analysis and got us a list of both the differentiation, its characteristics, as well as the unmet needs and prior results in other areas. And all of that has led us to develop some conclusions about how we would prioritize We expect to announce the next step for us in development in the next few months. I would say essentially no later than Q3. And at that point, we'll make clear what went into our decision and why we prioritized that. With respect to first-line breast cancer, that would obviously be a very long study, a very significant study. And it's one that we would probably say we'd have to essentially hold off for practical purposes until we get through our second line study. We think the data is still very interesting and compelling and certainly important for investors to consider if they're trying to evaluate what the long-term potential for the company is. I think for most drug developers, the goal is ultimately to have a drug that's capable of providing benefit for patients as early as possible. And the data that we updated and presented at ESMO suggests that we could potentially, or the data certainly points us in this direction, enhance significantly the progression-free survival period for patients who are treatment-naive, newly diagnosed with metastatic breast cancer. So long-term, you know, we think that would represent a significant opportunity to help a bigger group of patients for longer periods of time.
spk01: Got it. All makes sense. And maybe one other question just on the phase three question. In the past, you've mentioned how powering and the statistical analyses are conventional for the phase three. Are you providing any more specifics on powering assumptions for the three primary endpoint statistical analyses and how those factor into the regulatory path forward? Or would that be something that we could learn more about at a later point before the second half 24 readouts?
spk02: Well, you know, the fiscal analysis plan has been reviewed by the FDA. That was part of the process we went through last year and was re-described to folks. So we've vetted essentially our approach, the primary analysis that we proposed to use, and that's all been accepted by the FDA. You know, when you talk about conventional powering, I mean, typically for primary analysis, you know, I think the expectation is that you have certainly north of 85%. We think 90% is probably more typical. And we would, I would say, err on the side of being more conservative and have a higher power used for determining sample size and effects numbers to do the primary analysis. And then certainly, you know, the alpha is fairly standard, you know, typically, you know, 0.025 for on one-sided analysis. And so we're not breaking trail on any of that. And I think investors, you know, it shouldn't be a, a consideration, but those types of details typically we think are more appropriate to present when you're presenting the data.
spk01: Got it. Okay, that's helpful. Thanks for taking my questions.
spk06: I'll hop back in the queue. You're welcome. Thank you.
spk05: Next question comes from Boris Beaker with Cohen and Company.
spk07: Please go ahead.
spk08: Great. Thanks for taking our question. This is Nick on for Boris. so just a quick question on cell signia so i know that it was delayed and that you anticipate having the data in the first half of 2024 i was wondering if this is the same for the other fact trials if they've been if the potential data for them has also been pushed back slightly because of some of these delays yes i would say just in general the ability to get samples uh biopsy samples you know essentially
spk02: requires additional screening, and it results in a longer or greater pool of patients we have to pre-screen and screen to be able to get patients to enroll. And, you know, with the stop-start we had with the pandemic, you know, we used certain assumptions to project for enrollment, and I think those projections were slightly off. And, again, you know, the conditions that Celsignia trials are wholly different from Victoria 1, for instance. Victoria 1 is enrolling the equivalent of all comers, or essentially women who've progressed on a prior CDK4-6 and meet other eligibility criteria are able to enroll. There's no significant screening out required, which is the case with Celsignia, where only patients, roughly 20%, 25% of patients who have a research biopsy, and then are found to have hyperactive HER2 signaling or eligible. So that two-step process is harder to project the activity and also results in a slower rate of overall activity than you would have for a more conventional trial like Victoria 1.
spk08: Understood. Thanks for that detail. Just another quick one. I know what you guys ended up with cash. I was just wondering if you have had any guidance as to the cash runway or cash burn or anything like that.
spk02: We've previously provided guidance that this cash would take us to the end of 2025, and we are sticking with that guidance.
spk06: Great. Thank you very much. You're welcome.
spk05: Next question comes from Rohit Basim with Needham and Company.
spk07: Please go ahead.
spk09: Hi, this is Rohit on for Gil. Thanks for taking my questions. Can you tell us how many patients have been enrolled in the FACT I and FACT II studies? And then secondly, is there anything you can tell us about your ex-US plans? Thanks.
spk02: So we haven't provided updates on enrollment activities in those studies. And basically, we've been providing guidance on when we expect that interim analysis to be done. And as far as XUS, I guess, are you referring to commercial activities, development activities? Could you maybe provide a little more detail on that question?
spk09: Yeah, if you could just talk about your commercial preparation and activities, that would be great. Thanks.
spk02: Sure. Well, you know, our primary focus now is conducting the study and making sure our efforts are getting the data as soon as practically possible. As far as the commercial efforts, I mean, there's certainly a well-understood path to be able to commercialize, you know, that you prepare somewhat in parallel to preparation of your NDA. You know, the activities in the US or those early activities are in process. I would say we're on track with what you would expect for a company expecting to commercialize when we would. As far as ex-US, we haven't really described in any detail publicly what our plans are, but I would say for most biotechs in our position, they would look to some form of partnering to commercialize the drug XUS. We haven't made any commitments to that area. I think it's premature for us to finalize anything in that area. I doubt that we'll be breaking trail. I think taking the path that others have taken, finding partners to take on different markets or entire XUS is certainly a very plausible path for us to take.
spk06: Great. Thank you.
spk05: Next question comes from Alex Nowak with Craig Holland Capital Group.
spk10: Please go ahead. Okay, Greg, good afternoon, everyone. In the final cut or the latest cut of the ESMO data, were there any previously unreported toxicities or any higher rates of adverse events that popped up maybe that are new to this study or this cut of the data versus the prior cuts?
spk02: No, that's a great question. As it turns out, no. So, you know, the data has been updated relative to and we presented that data in December, so there really wasn't any change in that data as presented at ESMO. rather as presented at San Antonio. But I think what's very encouraging about the data is that we had patients that were on this drug for over four years or more, five years. And the toxicity profile for patients receiving this drug on a continuous basis for such an extended period of time is, we think, very encouraging. They stayed on the drug. The discontinuation rate was less than 10% with this group of patients due to treatment-related adverse events. And that can typically, or that would only be the case if the side effect profile, if the adverse events these patients were experiencing were tolerable and allowed them to maintain a good quality of life. So I think the data, the longer the follow-up period, the more encouraged we are because the safety data doesn't change.
spk10: No, that's certainly good. With the ESMO data and also the San Antonio data in hand here, I mean, progression-free survival, almost double what the San Antonio care would potentially represent. How can you utilize this to help with Victoria recruitment, whether it be sites or patients within those sites?
spk02: Well, we were just at ESMO last week, and I would say we presented this data, and a number of our investigators from Europe attended as well, some from the U.S., And I would say the importance of the data is that it highlights the role that GEDA-TELISA could potentially play long-term as a drug treating breast cancer patients. And the data is really, I would just say, remarkable. And I think that's the perspective that the investigators who are participating in our study have, which is, wow, this is great data. We want to investigate this drug. This drug seems very active and it sounds very exciting, and we want to make sure we We get our patients enrolled, and we want to see this drug get evaluated, and it certainly looks very promising. So a big part of what helps with any clinical study is being able to stay in front of investigators, have a reason to talk to them beyond just details of the trial. And any time you can provide additional data that further supports the hypothesis that the trial is evaluating is very helpful. It just helps establish our credibility, the drug's credibility, and their overall interest, because they they're trying to conclude that the likelihood of this drug being available to patients and playing a big role increases in probability when they see more data like that in their mind.
spk10: Yeah, absolutely. No, that's good to hear. And just last question, can you just remind us on the IP position within data and within breast? And then it certainly seems like you're building this to be a bit more of a platform going to other cancers. Just how do you take that IP and transition it from breast into the other indications that you're potentially targeting?
spk02: Sure. Sure. So any drug has multiple layers of patents or different approaches it takes to build out a patent state. Everybody will get patents for its active pharmaceutical ingredient, the API, the actual molecule itself. And then they'll get additional patents typically for different formulations. And we think the exclusivity for the drug that we're evaluating in breast cancer and other cancers would provide an exclusivity period through the end of 2039. So we think we have a long runway. And then with an IV drug, there's opportunities to think about how to optimize the formulation for different applications, and those present different opportunities to further extend the runway of IP protection.
spk06: Okay, great to hear. Appreciate the update. Thanks. You're welcome.
spk05: There are no further questions at this time.
spk07: I would like to turn the floor back over to Brian Sullivan for closing comments.
spk02: Thank you, everyone, for participating in the call today and for your ongoing support. We look forward to seeing you at the Craig Hallam Conference at the end of this month or at Jeffrey's Healthcare Conference in June. Hope everyone has a great evening. Goodbye.
spk07: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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