Q1 2025 Celcuity Inc Earnings Call
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Speaker Change: Good afternoon, ladies and gentlemen, and welcome to the <unk> first quarter 2025 financial results webcast conference call. At this time all lines are in listen only mode.
Following the presentation, we will conduct a question answer session. If at any time. During this call you require assistance. Please press star zero for the operator, I would now like to turn the conference over to upload about Hillary with ICR Health care. Please go ahead.
Thank you operator, and good afternoon to everyone. Thank you for joining us to review so acuity first reported weekly by financial results and business update.
Speaker Change: Earlier today for Beauty, Inc, released financial results for the first quarter ended March 31st 2025. The press release can be found on the investors section of the acuity website. Joining me on the call today are Brian Sullivan, <unk>, Chief Executive Officer, and co founder Vicky Hahn, Chief Financial Officer, as well as Igor corporate Trotsky, Chief Medical Officer, who.
Speaker Change: We'll be available during Q&A.
Speaker Change: Before we begin I would like to remind listeners that our comments today will include some forward looking statements.
Speaker Change: 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 SBC 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.
Speaker Change: To differ materially from those projected.
Speaker Change: 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 operation and prospects.
Speaker Change: For the future you can find a table reconciling the non-GAAP financial measures to GAAP measures in today's press release and with that I would now like to turn the call over to Brian Sullivan CEO of acuity. Please go ahead.
Brian Sullivan: Thank you, Florida, good afternoon, everyone and thank you for joining our first quarter financial results Conference call.
Brian Sullivan: We have an exciting year ahead of us with multiple upcoming clinical data readouts.
Brian Sullivan: We expect to report topline data from the picture you see a wild type patient cohort of our phase III Victoria, One trial in Q3 2025 and from the picture you see a mutated patient cohort in Q4 of 2025, we also anticipate reporting preliminary topline data for the phase one portion of our phase one b two trial in prostate cancer in late.
Brian Sullivan: Second quarter and finally, we made great progress activating trial sites for our phase III first line Victoria to trial over the past few months in our view each of our three programs has the potential to generate significant levels of revenue. If these programs. Ultimately result in regulatory approvals, we estimate that nearly 200000 late stage.
Brian Sullivan: Cancer patients globally would be eligible to be treated with capitalism.
Brian Sullivan: Let's turn now to our Victoria one trial.
Brian Sullivan: His III Victoria, one trial designed to evaluate get until the SIB in combination with full veteran with and without Pablo cyclic in patients with hormone receptor positive her two negative advanced breast cancer, whose disease has progressed on or after treatment with the CDK four six inhibitor.
Brian Sullivan: Victoria One trial includes two patient cohorts with independent statistical analysis plans and primary endpoints.
Brian Sullivan: The primary endpoints, Victoria, one are progression free survival or PFS as assessed by blinded independent Central review study.
Brian Sullivan: Studies designed to independently evaluate the picture you see a wild type cohort and the picture you see a mutant cohort.
Brian Sullivan: For the picture you see a wild type cohort there are two primary endpoints that will be tested hierarchically, whereas the picture you see a mutant patient cohort has a single primary endpoint. The primary analysis for each patient cohort is triggered upon reaching a predefined number of progression events.
Brian Sullivan: Based on the current blinded event rates, we anticipate the primary completion of the picture you see a wild type patient cohort will occur in June which would allow us to announce in a press release top line data in the third quarter and to present full results from this patient cohort at a major medical conference later in 2025.
Brian Sullivan: If positive we expect the data will support our first new drug application and if approved our transition to a commercial stage company if proven effective get up to listen in combination with full vesting and Pablo cyclic could offer a new standard of care for patients with HR positive <unk> negative advanced breast cancer, whose disease progressed on or after treatment with a C D.
Brian Sullivan: Okay four six inhibitor.
Brian Sullivan: So the picture you see a mutant patient cohort, we anticipate reporting topline data in the fourth quarter of 2025.
Brian Sullivan: Current second line treatment paradigm for HR positive <unk> negative patients with advanced breast cancer includes selective estrogen receptor degraders or surge like bold restaurant or Alaska trip as single agents or one of three approved Pam inhibitors combined with endocrine therapy. However.
Brian Sullivan: However, each of the Pam inhibitors, the only target the single Pam nodes, such as yesterday Alpha AK T. R. M torque one.
Brian Sullivan: Which is suboptimal because he uninhibited Pam no it's gonna do as competent story resistance.
Brian Sullivan: And patients who have received prior treatment with the CDK four six inhibitor. None of these single node Pam inhibitors have demonstrated efficacy in patients who have picture you see a wild type tumors, while only the picture you see a alpha in 8-K T inhibitor have reported benefit in patients with picks receipt of mutations.
Brian Sullivan: These results are consistent with the non clinical data that shows. These single note inhibitors are three to four times less potent and breast cancer cells without picks roussin mutations than in those with them.
Brian Sullivan: Of course.
Brian Sullivan: We recognize the foundation of <unk> role in this treatment landscape will require that get up to let's it'd be well tolerated and report a clinically meaningful result measured in terms of the incremental improvement in both PFS and the hazard ratio relative to standard of care.
Brian Sullivan: Breast cancer, Kols and regulators generally consider an incremental improvement in PFS of three months relative to its control to be clinically meaningful.
Brian Sullivan: Kurt M PFS or progression free survival benchmarks for patients pretreated with a CDK four six inhibitor patient population, we're evaluating our modest only two non came out related therapies have been evaluated in this patient population and received approval one reported a 1.9 months' incremental medium PFS improvement relative to.
Brian Sullivan: It's comparator in patients with ESR one mutations.
Brian Sullivan: The other did not report median progression free survival.
Brian Sullivan: Movement relative to current standard of care, but it did report a more favorable safety part profile in patients with picks receive mutations.
Brian Sullivan: The modest or no efficacy improvements on this benchmark.
Brian Sullivan: Both of these recently approved drugs has experienced rapid market adoption and penetration.
Brian Sullivan: Each drug reached revenue run rates within the first 12 months of watch estimated to be.
Brian Sullivan: Nearly half a billion dollars despite approvals that only address 330% to 40% of the eligible second line patient population. We believe this demonstrates the significant interest amongst oncologists for a new treatment options for these patients and a relatively low bar required to obtain adoption and market penetration.
Brian Sullivan: Could that potentially more important data point, then incremental PFS benefit to consider and advanced breast cancer when assessing the clinical benefit of one therapeutic regimen relative to another.
Brian Sullivan: Is the hazard ratio and this is because recent randomized studies evaluating therapies for patients with HR positive <unk> negative advanced breast cancer.
Brian Sullivan: I haven't rolled widely heterogeneous patient populations.
Brian Sullivan: Since physicians make different treatment decisions for patients depending on among other factors, how many lines of therapy, how well. They responded the prior therapy and which type of therapy. They may have received results from these studies can be hard to interpret using absolute median PFS or incremental PFS benefit alone.
Brian Sullivan: As a result.
Brian Sullivan: Topline M. PFS results from these studies don't provide sufficient clarity about the actual benefit that particular patient population may receive.
Brian Sullivan: Hazard ratio essentially factors out the differences in study populations and thus provides physicians with a a more objective benchmark.
Brian Sullivan: It's not only hope to report a hazard ratio that is statistically significant but one that compares favorably to the hazard ratio reported for other therapies available for second line patients, whose disease progressed, while receiving a CDK four six inhibitor.
Brian Sullivan: They've got to listen ultimately does receive FDA approval.
Brian Sullivan: For both the picture you see a wild type and mutant populations.
Brian Sullivan: We estimate a peak revenue potential for the second line indication could exceed $2 billion with just 40% market penetration.
Brian Sullivan: I'd like now to turn to our first line breast cancer program and our Victoria two trial did.
Brian Sullivan: Victoria two study is a global phase III open label randomized clinical trial evaluating the efficacy and safety has got it's less of in combination with sylvestris, plus investigator's choice of either ribas cyclic or policy clip now the <unk>.
Brian Sullivan: First line <unk> treatment for patients with HR positive <unk> negative advanced breast cancer.
Brian Sullivan: And these patients are endocrine therapy resistant.
Brian Sullivan: Proximately 638 subjects will be assigned to a cohort based on their pick through <unk> mutation status.
Brian Sullivan: Primary PFS endpoint for each of the cohorts will be evaluated independently.
Brian Sullivan: Prior to initiation of the phase III portion of the trial are safety run in study will be conducted in 12 to 36 bit participants to assess the safety profile, it's got to come together to elicit in combination with rabbits equipment for western.
Brian Sullivan: And during the first quarter, we completed our site qualification activities and we're now focused on activating the nearly 200 sites. We've qualified across North America, Europe, Latin America and Asia Pacific.
Brian Sullivan: <unk> also begun screening patients and expect to dose our first patient during the second quarter.
Brian Sullivan: Current standard of care first line treatment for most in the therapy resistant patients includes any of the three approved CDK four six inhibitors combined with full restaurant resort.
Brian Sullivan: From a recent trial suggests that the median PFS period for patients receiving one of these three regimens is only seven to eight months and these results compare poorly to the median PFS of 25 to 27 months reported for patients who are sensitive to endocrine therapy and to receive a similar regimen highlighting the significant a significant need for more effective therapies for <unk>.
Brian Sullivan: With advanced breast cancer that are resistant to androgen therapy.
Brian Sullivan: Now I'd like to turn to our phase one b two trial that is evaluating the safety and efficacy of got it to elicit in combination with their <unk> in patients with metastatic castration resistant prostate cancer, whose disease progressed, while receiving a next generation androgen receptor inhibitor.
Brian Sullivan: As one would be to study evaluates get it's Elisa in combination with their <unk>, which is an androgen receptor signaling inhibitor.
Brian Sullivan: In patients with metastatic castration resistant prostate cancer with.
Brian Sullivan: We've completed enrollment of the phase one dose escalation portion of the study and anticipate reporting topline data by the end of the second quarter. This year since we're at an earlier phase in this program our focus as optimizing the dose and schedule for this tumor type and drug combination.
Brian Sullivan: Dataset will include approximately 36 patients half of whom will have received the 120 milligram dose had got to solicit. The other half of 180 milligram dose each were administered on a three week on one week off schedule.
Brian Sullivan: We're comparing both the landmark PFS at six months and safety profile of these two arms to each other and to historical control data for second line metastatic castration resistant prostate cancer patients who have retreated with an androgen receptor inhibitor.
Speaker Change: And finally, we're excited about the opportunity we announced today to collaborate with the Dana Farber Cancer Institute, and Massachusetts General Hospital to evaluate to list of in combination with the damage to equipment Letrozole in patients with endometrial cancer. The rationale to initiate this study is based on compelling historical clinical data that indicates women with ER positive or type.
Brian Sullivan: One endometrial cancer may benefit from treatment with a P. S. K 8-K T M Tor inhibitor like EDA solicit in combination with endocrine therapy.
Brian Sullivan: Additionally results from our prior phase II clinical study evaluating <unk> as a monotherapy in patients with either type one or type two under Metrial cancer and these results were encouraging.
Vicki: So I'd like now to turn the call over to Vicki to review our finances.
Vicki: Thank you, Brian and good afternoon, everyone I'll provide a brief overview of our financial results for the first quarter of 2025.
Vicki: Our first quarter net loss was 37 million or <unk> 86 cents per share compared to $21 6 million net loss or <unk> 64, it sounds per share for the first quarter 2024.
Vicki: Our non-GAAP adjusted net loss was $34 7 million or <unk> 81 per share for the first quarter of 2025 compared to non-GAAP adjusted net loss of $19 9 million or <unk> 59 per share for the first quarter of 2024.
Vicki: Research and development expenses were $32 2 million for the first quarter of 2025 compared to $20 6 million for the first quarter 2024.
Vicki: Of the approximately $11 6 million increase in R&D expenses.
Vicki: $5 9 million was related to increased employee and consulting expenses and $5 7 million primarily related to activities supporting our ongoing clinical trials.
Vicki: General and administrative expenses were $3 9 million for the first quarter of 'twenty five compared to $1 8 million for the first quarter of 'twenty 'twenty four.
Vicki: Increased employee and consulting related expenses accounted for $1 6 million of the increase.
Vicki: Professional fees expanding infrastructure and other administrative expenses accounted for the remaining increase of approximately <unk> 5 million.
Vicki: Net cash used in operating activities for the first quarter of 2025 was $35 9 million compared to $17 1 million for the first quarter of 2020 four.
Vicki: We ended the quarter with approximately $205 7 million of cash cash equivalents and short term investments.
Vicki: We expect this cash cash equivalents and short term investments and draw downs on our debt facility to fund current clinical development program activities through 2026.
Brian Sullivan: I will now hand, the call back to Brian.
Vicki: Okay.
Speaker Change: We're now ready to turn the call over for questions.
Speaker Change: Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by the number one on your Touchtone phone you will hear a pump that you had has been raised.
Speaker Change: Should you wish to decline from the political process. Please press the star followed by the number too.
Speaker Change: You are using a speaker phone please lift the handset before pressing any.
Speaker Change: One moment. Please for your first question.
Speaker Change: Your first question comes from the line of Maury Raycroft from Jefferies. Your line is now open. Please go ahead.
Maury Raycroft: Hi, Congrats on the progress and thanks for taking my questions.
Speaker Change:
Speaker Change: It was going to ask one on Victoria one.
Speaker Change: Using the blinded Central review analysis, which can take longer can take a longer amount of time to analyze versus investigator assessed.
Speaker Change: So just wondering if you can provide more perspective on how long you think it will take to lock the data set sometime in June and then to get to the actual results and three Q. Just wondering if you can give more perspective on the amount of time there. So the primary completion date essentially he was referencing the data cutoff date, when when you stop collecting.
Speaker Change: And that's typically done and in our case will be done when you've achieved the priest.
Speaker Change: Prescribed event threshold and so from there you are engaged in the data cleaning process and ultimately.
Speaker Change: At that point you lock the database, so we expect that in Q3 and and where.
Speaker Change: If we achieve what we were very confident about achieving with completing.
Speaker Change: The achieving the primary completion date.
Speaker Change: We think.
Speaker Change: Yes, Q3 as you know.
Speaker Change: Absolutely certain time, when we would have the data available and you know, we're not going to get into more specificity in terms of months, but but again I think.
Speaker Change: There's no further risk of delay at this point in the trial with being able to report these results.
Understood, but I guess for that amount of time from locking the database to reporting the data.
Speaker Change: Any general estimate on how long that could take.
Speaker Change: I mean, typically you would see no more than three months and typically less than okay.
Speaker Change: Got it Okay and then.
Speaker Change: Understanding that our overall survival might not be fully mature at the top line do you think you would be able to provide some sort of an update on just the directionality of survival trend.
Speaker Change: But are you seeing between the three arms at the data readout.
Speaker Change: The data readout that we expect to make are in our press release will only include the median PFS in the hazard ratios for the two primary analysis. The subsequent data will be analyzed where either presented at a medical conference later in the year.
Speaker Change: Got it okay.
Speaker Change: I'll stop there and hop back in the queue. Thanks, Okay. Okay. Thanks.
Speaker Change: Yeah.
Speaker Change: Your next question comes from the line of Andrew Barron from Leerink. Your line is now open. Please go ahead.
Ethan: Hi, Good afternoon. This is ethan on for Andy Thanks for taking our question.
Speaker Change:
Speaker Change: Wanted to get your thoughts on the potential impact of Serena six on the second line setting for HR positive patients. Just curious you know what could brought adoption from this need for data.
Speaker Change: I'll type population and also kind of a similar question what could be potentially a part b to get out in the community.
Speaker Change: Patient population as well thank you.
Speaker Change: Sure well, we don't think that would affect us at all these are still essentially first line CDK four six patients.
Speaker Change: It's actually current practice amongst many doctors are depending on the profile of their patients to transition them off let resolved so for investment depending on how they believe their patients are progressing. So this trial essentially identified a more precise way of determining the timing and what appears to be a very effective way of doing that.
Speaker Change: But the patients in our trial are essentially.
Speaker Change: Consistent with the patients that this trial.
Speaker Change: Evaluated was for patients who receive CDK four six and eventually progressed and so if our data favorable we'd expect physicians to then seek to continue treatment with the CDK four six inhibitor was with one that includes capitalism.
Speaker Change: And I don't think the.
Practice will vary between those patients who lack.
Speaker Change: Lacked victory seeing mutations versus those who do have picks VCA mutations I think the primary effect maybe on how other CDK four six plus URL sword combinations get used.
Yeah.
Speaker Change: Yeah.
Okay.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Operator.
Speaker Change: Yeah.
Speaker Change: Yeah. Your next question comes from Bella Terra Banca <unk>.
Speaker Change: D D. Cowen Your line is now open. Please go ahead.
Speaker Change: Yeah.
Speaker Change: So I was wondering if you could provide any updated thoughts on what minimum HR you would you would consider to be good data in the wild type of update not just for hitting stats, but in relation to other datasets in indication like three to six it was just mentioned and in other marketed products and.
Speaker Change: What U K O L want to see in order to use it. Thanks so much.
Speaker Change: No I appreciate the question at this time, you know with the data a fairly imminent, we're not going to comment it specificity about those types of projections we've commented.
Speaker Change: Because the the analysis is easier to do that you know an incremental three months would be considered clinically meaningful certainly any statistically significant hazard ratio. That's consistent with three months would also be considered clinically meaningful how the regimen in the results specifically stack up against other regimens.
Speaker Change: Regimens.
Speaker Change: Will just be a function of how those two sets of data compare.
Speaker Change: Okay, great. Thanks.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: As a reminder, if you wish to ask a question. Please press star one.
Speaker Change: Your next question comes from the line of <unk> Gill from Needham <unk> Company. Your line is now open. Please go ahead.
Speaker Change: Good afternoon, and thanks for taking our question so just to.
Speaker Change: So let me clarify this.
Speaker Change: What exactly drove the slight change in timing for the wild type readout.
Speaker Change: And should we expect to see no change in the picture you see a timeline and as a follow on.
Speaker Change: Investment if any would you need to do to support the endometrial cancer collaboration. Thank you.
Speaker Change: Sure.
Speaker Change: As far as what drove it again I think we've indicated on prior calls that.
Speaker Change: Cause you know this is a three arm trial and the primary analysis is driven by reaching an advent threshold in each of two different analyses. It's it's.
Speaker Change: And precise for us to.
Speaker Change: <unk> estimate the timing I think there's this variance in.
Speaker Change: In how those results are distributed within the three Ah that.
Speaker Change: Aggregate total of events for all three arms and where we're now at a point, where you know the potential for variability is de Minimis and so that's why we have confidence about being.
Speaker Change: Being able to establish.
Speaker Change: Established data cut off in June.
Speaker Change: And.
Speaker Change: As far as the Q4 for the picture you see a mutant we're confident about that it's.
Speaker Change: It's a less complicated.
Speaker Change: Racking of event threshold, because even though the three arms.
Speaker Change: The third arm comprises only about 15% of the total.
Speaker Change: So the.
Speaker Change: Our primary analysis event threshold is much more closely aligned.
Speaker Change: The aggregate of the three arms.
And as far as the endometrial study.
Speaker Change: Study that we announced.
We are supplying drug product in and providing clinical support.
Speaker Change: So that study. So we don't think we'll have any incremental financial effect on the company.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Operator.
Speaker Change: Next question comes from Nevada, Oliver Mccammon from Whiteside Capital. Your line is now open. Please go ahead.
Oliver Mccammon: Alright, thanks for the update and taking my question, maybe we'll take a break from Victoria one for a moment I'm curious if you can just remind us on some of the prior proof of concept data for targeting the <unk> K a T in Cork halfway in prostate cancer and more specifically what you think the potential is for <unk>.
Oliver Mccammon: <unk> inhibition versus single node, but ours like Cabot Bastard, Ed and then I'm also curious if you plan to share PSA data at the time of the update late in the second quarter. Thanks again for the question sure.
Oliver Mccammon: Sure.
Oliver Mccammon: And so the data that's been reported with <unk>.
Oliver Mccammon: Either.
Oliver Mccammon: In particular at AK T inhibitor, so as has been the.
Oliver Mccammon: Inhibitors from this general class of drugs that have been evaluated.
Oliver Mccammon: And in patients with.
Oliver Mccammon: Metastatic castration resistant prostate cancer and a cap of acid Herb reported positive data with patients who have a hormone sensitive.
Oliver Mccammon: Prostate cancer.
Oliver Mccammon: That was favorable in patients who have <unk> mutations and so a subgroup of the total population.
Oliver Mccammon: You know the non clinical data that we've reported and published.
Oliver Mccammon: Syndicate to get is equally active independent of the status of P 10, which is the primary mutation in prostate cancer.
Oliver Mccammon: And kept divestiture of hasn't demonstrated activity or if it's a significantly less active.
Oliver Mccammon: And tumor cells prostate tumor cells that that lack pizza and mutations and so we think that data is encouraging because it demonstrates the role of the pathway plays.
Oliver Mccammon: And similar to breast cancer get it's Elisa in non clinical models.
Oliver Mccammon: They'll be significantly more potent and cytotoxic than let's say, an 8-K T inhibitor like cap of assets herb or the other.
Oliver Mccammon: Drugs that have been approved.
Oliver Mccammon: Address the Pam pathway and so yeah. It was a major part of the rationale.
Oliver Mccammon: For.
Oliver Mccammon: Evaluate and get a in this setting that a the pathway has been.
Oliver Mccammon: Demonstrated to be approved and be the drugs that have demonstrated activity or at least non clinically.
Oliver Mccammon: Less active than get out, which we think creates a very strong rationale.
Oliver Mccammon: For the trial.
Oliver Mccammon: As far as the update the update will really just focus on the primary analysis and safety data and then the rest of the data we would expect to report a medical meeting in 2025.
Speaker Change: Super helpful. Thank you again Youre welcome.
Brian Sullivan: There are no further questions at this time, please continue Mr. Brian Sullivan.
Brian Sullivan: Oh well. Thank you. We appreciate your interest in so acuity and <unk> will be attending and presenting at several investor conferences over the next few weeks. So look forward to seeing some of you there.
Brian Sullivan: Goodbye.
Brian Sullivan: Okay.
Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
Speaker Change: Okay.