Celcuity Inc. Q1 2023 Earnings Call
Speaker 1: I we C.
Speaker 1: The.
Speaker 2: 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 Doole.
Speaker 2: with ICR last week. Please go ahead.
Speaker 3: Thank you, operator, and good afternoon to everyone on the call. Thank you for joining us to review Salqouity's first quarter 2023 financial results and business update. Earlier today, Salqouity released financial results for the first quarter ending March 31, 2023. The press release can be found on the investors section of the website.
Speaker 3: Joining me on the call today are Brian Sullivan, Cell Cuehides, Chief Executive Officer and Co-Founder, Vicki Han, 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.
Speaker 3: 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.
Speaker 3: 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.
Speaker 3: 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 devaluate 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
Speaker 3: ongoing core operations and prospects for the future.
Speaker 3: You can find the table reconciling the non- GAAP financial measures to GAAP measures in today's press release.
Speaker 3: With that, I would now like to turn the call over to Brian Sullivan, CEO of CellQ&E. Please go ahead, sir.
Speaker 4: 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.
Speaker 4: I'll only make brief prepared remarks today.
Speaker 4: I'm very pleased for the execution to date of our Victoria 1 Phase 3 clinical trial and involvement activities at our trial site.
Speaker 4: As we've reported previously, Victoria wanted to evaluate and get a felicit in combination with full vestraint with and without palposeclob. In adults with HR positive or too negative advanced breast cancer, lose disease progressed while receiving a CDK46 inhibitor. Our team is relentlessly focused and keeping us on track to report the primary analysis for the PIC3CA non-muted patient subgroup in the second half of 2024, and the primary analysis So, there's a tightest results and Tiger Pr warrant actually expands of the same leg serum spread using a single
Speaker 4: If we're consistent with our prior guidance.
Speaker 4: At the Asmode 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.
Speaker 4: We think the data is very encouraging. In our post-apresentation, we provided updated efficacy and safety data and treatment naive patients who are enrolled in Escalation RMA and expansion RMA of our phase one B study.
Speaker 4: We've previously reported data for this group of patients at the San Antonio breast cancer symposium last month.
Speaker 4: cutoff data June 29th, 2022. But the median PFAS in Expansion RMA had not yet been reached. As of a March 16th, 2023 data cutoff date, with the benefit of the additional follow-up period, we were able to report final median progression for your survival and median duration of response data for these patients.
Speaker 4: For treatment naive patients, an escalation RMA, median progression free survival was 45.8 months, and for patients in expansion RMA, it was 48.6 months.
Speaker 4: When the results were treated, I had patients from each of these arms are analyzed together.
Speaker 4: Media and Progressive Feast Survival was 48.6 months, and media integration of response was 46.9 months.
Speaker 4: These results compare very favorably to the median PFS of 24.5 months reported in the THALOMA 3 study for PALVOS-CYCLID and PLUS LECTRAZOL.
Speaker 4: We think these results demonstrate the intrinsic role the PI3K mTOR pathway plays as a disease driver in advanced HR positive for 2-negative breast cancer.
Speaker 4: The data also highlight the potential opportunity to develop Gettysillus as a first line treatment option. The data also highlight the potential opportunity to develop Gettysillus as a first line treatment option.
Speaker 4: We continue to characterize guttophilic activity in various tumor types and compare its activity to other drugs in the class.
Speaker 4: as we previously reported. The nonclinical studies we presented at ASCO-GU in February for prostate cancer.
Speaker 4: and at AACR in April for gynecological cancers.
Speaker 4: highlighted, got up to this differentiation from other drugs in this class.
Speaker 4: In each of the studies we performed in all of the tumor types assessed, get it to listen to demonstrated superior therapeutic effect relative to the other P3K, AKT, and MTOR inhibitors evaluated.
Speaker 4: Based on the results from these internal non-clinical studies.
Speaker 4: 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 GEDIF, ELISP, and these stalemate fil humanitarian sites.
Speaker 4: We'll provide an update on our clinical development priorities later this year.
Speaker 4: And finally, the fact one and fact two trials are continuing to enroll patients with early stage HR positive, hurt you negative breast cancer. These hurt two pathways hyperactive as detected with our staff's signature test. We now expect to announce interim results from these studies in the first half of 2024.
Speaker 4: And with that, I'll now turn the call over to Vicki Han to review our financial results. And with that, I'll now turn the call over to Vicki Han to review our financial results.
Speaker 5: Thank you, Brian , and good afternoon, everyone. I'll provide a brief overview of our first quarter 2023 financial results.
Speaker 5: The first quarter net loss was 11.9 million or 55 cents loss per share compared to a net loss of 7.9 million or 53 cents loss per share for the first quarter of 2022.
Speaker 5: Because these quarterly net losses include significant non-cash items, including stock base compensation and interest expense, we also include in our press release, non-gap adjusted net loss for the quarter ending March 31, 2023.
Speaker 5: Our non-GAP adjusted net loss for the first quarter of 2023 was 10.2 million or 47 cents loss per share compared to non-GAP adjusted net loss for the first quarter of 2022 of 7 million or 47 cents loss per share. Our non-GAP adjusted net loss for the first quarter of 2020 was 10.2 million or 47 cents loss per share.
Speaker 5: Research and development expenses were 11.3 millions for the first quarter of 2023 compared to 6.7 million for the first quarter of 2022.
Speaker 5: The approximately 4.6 million increase resulted primarily from cost supporting activities related to the Victoria 1 Pivotal trial.
Speaker 5: 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, dot-based compensation and professional fees associated with being a public company.
Speaker 5: Net cash used in operating activities for the first quarter of 2023 was 12.9 million compared to 5.9 million to the first quarter of 2022. This was the result of non-gap adjusted net loss of 10.2 million working capital changes of approximately a million.
Speaker 5: and non-cash interest income of approximately 1.7 million.
Speaker 5: We end the decoder with approximately 157.5 million of cash, cash equivalents, and short-term investments compared to 168.6 million at December 31, 2022. With that, I will now hand the call back to Brian . Brian .
Speaker 2: Thank you, Vicki. Operator, could you please open the call for questions? 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 lines in the question queue.
Speaker 2: You may press start you if you would like to remove your question from the key for participants using its particular equipment. It may be necessary to pick up your headset before pressing this car keys. One moment please while we pull for questions.
Speaker 6: Our first question comes from Marie Raycroft, Lisa Dafferies. Please go ahead. Hi, congrats on the progress and things for taking my questions. I was wondering as it relates to the preclinical data that you presented at ASCO.JU and the ASR data and the positive Ezmo breast cancer frontline PFS data.
Speaker 6: Can you talk more about what gaining factors are to inform your next steps with development later this year? I guess what would go into those decisions and what would be based on the Phase 3 progress?
Speaker 4: So we've been so many independently evaluating the landscape of opportunities to consider for development of Getta Felicit. And so in parallel, R&D group has done a great job of reporting and developing the data, conducting the studies for the data that we presented as ASCO and NAACR. And that helps inform our decisions.
Speaker 4: Simultaneously, we've been doing a review of prior published data from clinical trials.
Speaker 4: evaluating indicators or inhibitors in this class. And then we've also evaluated. And remember,uj this information organizing nuggets?
Speaker 4: The market opportunity standard of care treatment, the on that need, essentially doing a holistic analysis of caterpillars of both differentiation, its characteristics as well as the on that needs and prior results in other areas. And all of that has led us to develop some conclusions about how we would prioritize.
Speaker 4: We expect to announce the next step for us in development in the next few months. I would say essentially by no later than Q3.
Speaker 4: And at that point we'll make clear what went into our decision and why we prioritize that. Let's respect a first line breast cancer.
Speaker 4: That would obviously be a very long study, 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 data is very interesting and compelling and certainly important for investors to consider if they're trying to evaluate the long term.
Speaker 4: and IE, Milly Diagnosed with Medesthetic breast cancer. So long term, we think that would represent a significant opportunity to help a bigger group of patients for longer periods of time.
Speaker 6: Got it. All makes sense. And maybe one other question just on the Phase 3. In the past, you've mentioned how powering and the statistical analyses are conventional for the Phase 3. Are you providing any more specifics on powering assumptions for the three primary endpoint statistical analyses?
Speaker 4: and how those factor into the regulatory path forward. Or would that be something that we could learn more about it later point before the second half, 24 readout? Well, the fiscal analysis plan has been reviewed by the FDA. That was part of the process we went through last year and was we described to folks. So we've vetted essentially our approach, the primary analysis that we proposed.
Speaker 4: 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...
Speaker 4: I would say air on the side of being more conservative than have a higher power used for determining the sample size and effects numbers about to do the primary analysis. And then certainly, you know, the alpha.
Speaker 4: is fairly standard, typically, 0.025 on one side and analysis. So we're not breaking trail on any of that, I think.
Speaker 4: investors, you know, it shouldn't be a consideration, but, but, you know, those types of details typically, you know, we think they're more appropriate to present when you're presenting the data. Got it. Okay, that's helpful. Thanks for taking my questions. I'll have back in the queue. You're welcome. Thank you. Thank you.
Speaker 2: Next question comes from Boris Speaker with Coen and Company. Please go ahead.
Speaker 6: Thanks for taking our question. This is Nick on for Boris. So just a quick question on cell signature. 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 the failures.
Speaker 4: Yes, I'll say just in general the
Speaker 4: ability to get samples, biopsy samples, you know, essentially.
Speaker 4: It 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 with the stop start we have with the pandemic. We use certain assumptions to project enrollment. And I think those projections are slightly off.
Speaker 4: And again, you know, the conditions that...
Speaker 4: So, significant trials, PACE, are wholly different from Victoria I. For instance, Victoria I is enrolling equivalent of all commerce, or essentially a woman who progressed on the prior CDK46 and meet other eligibility criteria are able to enrol. There's no significant...
Speaker 4: screening out required, which is the case with cell signal where only patients roughly 20%, 25% of patients who have a research biology and then are found to have hyperactive hercose signaling are eligible. So that two-step process is harder to project the activity.
Speaker 4: and also result in a slower rate of overall activity and you would have for a more conventional trial like Victoria Lone.
Speaker 4: Understood, thanks for that detail. Just another quick one. I know what you guys ended up with, Cass. I was just wondering if you have had any guidance as to the cash runway or cash burn or anything like that. We've previously provided guidance that this cash would take us to the end of 2025 and we are sticking with that guidance. Okay, thank you very much.
Speaker 4: Thanks for that detail. Just another quick one. I know what you guys ended up with, Cass. I was just wondering if you have had any guidance as to the cash runway or cash burn or anything like that. We've previously provided guidance that this cash would take us to the end of 2025. And we are sticking with that guidance. Great. Thank you very much. You're welcome.
Speaker 2: Next question comes from Roe Heatbosium with Need Herb and Company. Please go ahead.
Speaker 7: Hi, this is Robert on for Gail. Thanks for taking my questions. Can you tell us how many patients have been enrolled in the FACT-1 and FACT-2 studies? And then secondly, is there anything you can tell us about your XUS plans? Thanks.
Speaker 4: So we haven't provided updates on enrollment activities in those studies and basically providing guidance on when we expect that in an analysis to be done.
Speaker 4: And as far as XUS, I guess are you referring to commercial activities, development activities, the budget meeting, business.
Speaker 4: I guess you referring to commercial activities, development activities, maybe do I have a little more detail on that question.
Speaker 7: Yeah, if you can just talk about your promotional preparation and activities, that would be great.
Speaker 4: Well, primary focus now is conducting the study. And...
Speaker 4: making sure our efforts are getting the data as soon as practically possible. As far as the commercial effort, I mean, there's certainly...
Speaker 4: Well, and it's good path to be able to commercialize that you prepare someone in parallel to preparation of your NDA. The activities in the US or those early activities are in process. I would say we're on track with...
Speaker 4: what you would expect for a company expecting to commercialize when we would. As far as XUS, we haven't really described in any detail publicly what our plans are, but I would say, you know, for...
Speaker 4: most biotechs in our position, they would look to some form of partnering to commercialize the drug XUS. And I, you know, we haven't made any commitments to that area. I think it's premature for us to, yeah.
Speaker 4: finalize anything in that area but I doubt it will 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
Speaker 4: I finalize anything in that area, but I doubt it will 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.
Speaker 2: Great, thank you. Next question comes from Alex Nauwak with Greg Holm, Capital Group. Please go ahead.
Speaker 8: Okay, great. Good afternoon, everyone. In the final cut or the latest cut of the asthma data, were there any previously unreported toxicity 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?
Speaker 4: No, that's a great question. As it turns out, no. So the data has been updated relative to and represented that data in December . So there really wasn't any change in that data as presented at ESMO, rather as presented at San Antonio.
Speaker 4: But I think what's very encouraging about the data is that we had patients that were on the stroke for over four years, or more, five years.
Speaker 4: 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. This continuation rate was less than 10% with this group of patients due to treatment related adverse events. And that can typically, that would only be the case if the side effect profile for the adverse events, these patients were experiencing, we're talking about.
Speaker 9: here I mean
Speaker 8: progression free survival, almost double with the standard of care, with potential represented. How can you utilize this to help with Victoria to improve whether it be sites or patients within the site? Well, we're just at asthma last week.
Speaker 4: And I would say we presented this data and a number of our investigators from Europe attended as well, some from the US. And I would say the importance of the data is that it highlights the role they get to listen, could potentially play long term as a drug treating breast cancer patients.
Speaker 4: And, you know, 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 sounds very exciting and we want to make sure we...
Speaker 4: We get our patients enrolled and we want to see this drug get evaluated and it certainly looks very promising. So, you know, a big part of what helps with any clinical study is being able to stay in front of investigators, how to reason the talk them beyond the details of the trial. And anytime you can...
Speaker 4: Provide additional data that further support for 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, they're trying to conclude that the likelihood of this drug being available to patients and playing a big role is, is,
Speaker 8: increases in probability when they see more data like that. And they're mine. Yeah, absolutely. No, that's good to hear. And just last question, can you just remind us on the IP position within data, it within breast? And then certainly seems like your building is to be a bit more of a platform going to other cancers. Just how do you take that IP and transition and come breast into the other indications? So you're potentially getting it. Sure, sure. So any drug that's multiple?
Speaker 4: And the layers of patents are different approaches it takes to.
Speaker 4: Yeah, build out a patent estate. And everybody will get patents for its packet pharmaceutical ingredient, the ATI, the actual molecule itself.
Speaker 4: And then they'll get additional patents typically for different formulations.
Speaker 4: 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.
Speaker 4: over to Brian Sullivan for closing comments. Thank you everyone for participating in the call today. For your ongoing support, we look forward to seeing you at the Craig Hallum conference at the end of this month or at the Jeffries Healthcare Conference in June . Hope everyone has a great evening. Goodbye. Bye.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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