Q3 2024 Celcuity Inc Earnings Call
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Speaker Change: Good afternoon, ladies and gentlemen, and welcome to the Selcuity Third Quarter 2024 Financial Results Conference Call.
At this time, all lines are in lithuanian mode.
Speaker Change: Following the presentation, we will conduct a question and answer session. If at any time during the call you require immediate assistance, please press star zero for the operator. This call is being recorded on November 14, 2024.
Speaker Change: I would now like to turn the call over to Apoorva Chaluri. Please go ahead.
Apoorva Chaluri: Thank you, Operator, and good afternoon to everyone on the call. Thank you for joining us to review Salcuity's 3rd Quarter 2024 Financial Results and Business Update.
Apoorva Chaluri: Earlier today, Silk Unity, Inc. released financial results for the third quarter ended, September 30, 2024.
Apoorva Chaluri: The press release can be found on the Investor section of the website. Joining me on the call today are Brian Sullivan, Salcuti's Chief Executive Officer and Co-Founder, Vicky Hahne, Chief Financial Officer, as well as Igor Gorbachevsky, Chief Medical Officer, who will be available during Q&A.
Apoorva Chaluri: Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements.
Apoorva Chaluri: 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.
Apoorva Chaluri: 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.
Apoorva Chaluri: On this call, we will also refer to non-GAAP financial measures.
Apoorva Chaluri: 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.
Speaker Change: You can find a table reconciling the non-GAAP financial measures to GAAP financial measures in today's press release. And with that, I would now like to turn the call over to Brian Sullivan, CEO of Zocuity. Please go ahead.
Thank you, Apoorva, and good afternoon, everyone.
Brian Sullivan: We continue to make great progress advancing the clinical development of getatolysib this quarter. Overall enrollment in Victoria 1, our phase 3 clinical trial evaluating getatolysib plus fulvestrin with and without palviciclib in the second line setting remains robust and on track.
Brian Sullivan: It reflects the excellent execution by our clinical development and operations teams and great support from the investigators at our sites.
and enrollment in the PIC-3CA mutant cohort is on plan.
Brian Sullivan: Our Victoria II Phase III clinical trial that will be evaluating Gettatilicid plus fulvestrin and a CDK4-6 inhibitor in the first-line setting remains on track to enroll its first patient in the second quarter of 2025.
Brian Sullivan: and our Phase 1b2 trial evaluating patients with metastatic castration resistant prostate cancer.
Brian Sullivan: is ongoing and remains on track to report preliminary data in the second quarter of 2025.
Brian Sullivan: The primary endpoints for the Victoria 1 clinical trial are progression-free survival, or PFS, per RECIS 1.1 criteria, as assessed by blinded independent central review.
Brian Sullivan: The study is designed to independently evaluate a PIK3CA wild-type patient cohort and a PIK3CA mutant patient cohort.
Brian Sullivan: For the PIK3CA wild-type cohort, there are two primary endpoints that will be tested hierarchically, whereas the PIK3CA mutant patient cohort has a single primary endpoint.
Brian Sullivan: The primary analysis for each patient cohort is triggered upon reaching a predefined number of progression events.
Brian Sullivan: with a PIK3CA wild-type patient cohort. The threshold number of events for both primary endpoints must be achieved before the primary analysis is triggered.
Brian Sullivan: Based on our current forecast of reaching the event thresholds that will trigger primary analysis, we expect to report top-line data for the PIC3CA wild-type cohort sometime in late Q1 2025 or Q2 2025.
Brian Sullivan: and to report COPLINE data for the PIK3CA mutant cohort in the second half of 2025.
Brian Sullivan: If the results from the PIK3CA wild-type patient cohort are positive, we would expect to file a new drug application, or NDA, with this data, and follow up with a supplemental NDA, or SNDA, if the results from the PIK3CA mutant cohort are also positive.
Brian Sullivan: Obviously, the foundation of getatelicib's potential future positioning will require the getatelicib report a clinically meaningful median PFS benefit. Current median PFS benchmarks for patients pre-treated with a CDK4-6 inhibitor are modest.
Brian Sullivan: Published reports of median progression-free survival for the SIRDS range from 2 to 3.8 months, and in patients with PIK3CA mutations ranges between 5.5 and 7.3 months for the AKT and PI3K-alpha inhibitors.
Brian Sullivan: The two most recently approved therapies for this patient population reported between 2 and 3.5 months of incremental PFS benefit. The threshold KOL is generally considered to be clinically meaningful.
Brian Sullivan: In addition, we've consistently heard from oncologists that they greatly prefer to delay use of chemotherapy or ADCs until the benefit from endocrine backbone regimens is exhausted.
Brian Sullivan: We also think the Geta-Telusib safety profile may also favor its potential positioning in a future treatment landscape. Geta-Telusib's treatment-related discontinuation rate was only 4% in the Phase 1b arm with the Phase 3 intermittent dose schedule, which is comparable to the 6 to 8 percent discontinuation rates for the CDK4-6 plus fulvestrin regimens.
Brian Sullivan: These results compare favorably to the treatment-related discontinuation rates reported in the Phase III studies for Alpalissa plus Fulvestrin, where 26% of patients discontinued, and Everolimus plus Exemastain, where 24% of patients discontinued.
Brian Sullivan: The results for Gettysillisib are especially encouraging given that patients in the Phase 1b study did not receive prophylactic treatment for stomatitis.
Brian Sullivan: Since we are prescribing stomatitis prophylaxis in our Phase 3 trial, we would expect fewer stomatitis-related adverse events, which would further enhance getatillus's already promising safety profile.
Brian Sullivan: We recognize that the treatment landscape is evolving with new potential therapies under development. Our view is that the underlying biological drivers of HR-positive, HER2-negative, advanced breast cancer will ultimately determine which regimens become standard of care.
Three interconnected signaling pathways, estrogen, cyclin D1, CDK4-6.
Brian Sullivan: and PI3K-AKT-MTOR promote this disease. And we believe that simultaneous blockade of all three of these pathways is required to optimize anti-tumor control.
Brian Sullivan: And this suggests that a triplet regimen that addresses these drivers, whether in the first or second line setting, may have a long-term advantage versus a doublet regimen or monotherapy that addresses just one or two of these signaling pathways.
Brian Sullivan: Additionally, a triplet regimen that could treat all patients, regardless of PIK3CA or ESR1 status, would have an even greater advantage.
Brian Sullivan: We believe that a triplet regimen that includes gadathelicib is well-positioned to establish this new standard of care, and we're optimistic that the VIC-001 data from our PIK3CA wild-type and mutant cohorts can live up to this potential.
Brian Sullivan: Feedback we're receiving from oncologists and market access stakeholders in conjunction with our preliminary commercial launch-related activities further reinforces our optimism about the potential for getatelicib. Of particular note is the encouraging feedback received regarding getatelicib's IV route of administration.
Brian Sullivan: This preliminary research suggests that IV administration will not be a barrier to utilization of getatelizum and in fact likely offers important advantages, particularly from a market access and adherence to therapy perspective.
Brian Sullivan: If GADF-ELISA ultimately does receive FDA approval for both the PIK3CA wild-type and mutant populations
Brian Sullivan: We estimate the peak revenue potential for the second line and delay indication alone could exceed $2 billion.
Brian Sullivan: Turning to our Victoria 2 study, our site qualification activities to support activation of up to 200 sites across North America, Europe, Latin America, and Asia are on track.
Brian Sullivan: We're very pleased with the interest we're receiving from our current Victoria One sites as well as new sites that have expressed interest in participating in this study. We expect these activities will allow us to enroll our first patient in the second quarter of 2025.
Brian Sullivan: The Victoria 2 study is a global phase 3 open-label, randomized clinical trial evaluating the efficacy and safety of getatelicid in combination with fulvestrin plus a CDK4-6 inhibitor as a first-line treatment for patients with HR positive, HER2 negative, advanced breast cancer.
who are endocrine therapy resistant.
Brian Sullivan: prior to the initiation of the phase three portion of the trial. The safety run-in.
Brian Sullivan: The study will be conducted in 12 to 36 participants to assess the safety profile of gadotellisib in combination with rivacyclob and fulvestrin.
Brian Sullivan: Earlier this year, we dosed our first patient in our Phase 1b2 trial that is evaluating getatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer.
Brian Sullivan: This study is ongoing and we are on track to report preliminary data from this study in the second quarter of 2025.
Brian Sullivan: Just recently, in October, the journal Cancers published results of our non-clinical studies in gynecological cancer cell line models, highlighting the differences between single-node inhibitors of the PI3K-AQT mTOR pathway and gadatolisib.
Brian Sullivan: The published manuscript is available online and on the publication sections of CellQIty's website.
Brian Sullivan: The results from these studies are consistent with the nine clinical studies we published earlier this year that evaluated breast and prostate cancer cell line models.
Brian Sullivan: and all three tumor types get a thalyssib demonstrated superior potency and cytotoxicity compared to single-node PI3K-AKT mTOR inhibitors.
Brian Sullivan: And this December, we're looking forward to presenting one clinical poster and two non-clinical posters at the San Antonio Breast Cancer Symposium. Our clinical poster will present overall survival data from our Phase 1b clinical trial that evaluated getatelicib in combination with palviciclib and endocrine therapy.
Brian Sullivan: The two non-clinical posters will present data that further characterizes the mechanism of action of getatelicib and its effect on key breast cancer cell metabolic functions.
Brian Sullivan: Overall, we're very pleased with the progress we made this quarter, advancing the clinical development of GADF-ELISA.
Speaker Change: I'd like now to turn the call over to Vicky, who will review our financial results.
Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the third quarter 2024.
Vicky Hahne: Our third quarter net loss was $29.8 million, or $0.70 per share, compared to $18.4 million net loss, or $0.83 per share, for the third quarter of 2023.
Vicky Hahne: This includes significant non-cash items, including stock-based compensation and interest. We also included in our press release non-GAAP-adjusted net loss for the quarter ended September 30th, 2024.
Vicky Hahne: Our non-gap adjusted net loss was $27.6 million or $0.65 per share for the third quarter of 2024 compared to non-gap adjusted net loss of $17.3 million or $0.78 per share for the third quarter of 2023.
Vicky Hahne: Research and development expenses were $27.6 million for the third quarter of 2024, compared to $17.5 million for the third quarter of 2023.
Vicky Hahne: $6.3 million primarily related to activities supporting the Victoria 1 Phase 3 trial, the Phase 1B2 prostate trial, and the initiation of the Victoria 2 Phase 3 trial.
Vicky Hahne: The remaining $3.8 million was related to increased employee and consulting expenses.
Vicky Hahne: General and administrative expenses were $2.5 million for the third quarter of 2024, compared to $1.4 million for the third quarter of 2023.
Vicky Hahne: Employee and consulting related expenses accounted for 0.9 million of the increase.
Vicky Hahne: Professional fees and other administrative expenses accounted for the remaining increase of approximately $0.2 million.
Vicky Hahne: compared to cash, cash equivalents, and short-term investments of $180.6 million at December 31, 2023.
Vicky Hahne: The increase of $83.5 million in cash, cash equivalents, and short-term investments
Vicky Hahne: was the result of several financing activities that occurred year-to-date through September 2024 and yielded net proceeds of approximately $138.3 million.
operating cash used of approximately $55.8 million.
I will now hand the call back to Brian.
Brian Sullivan: Thank you, Vicky. Operator, could you please open the call for questions?
Thank you.
Speaker Change: Ladies and gentlemen, we will now begin the question and answer session.
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One moment please for your first question.
Speaker Change: Your first question is from Mari Raycroft from Jeffries. Please go ahead.
Speaker Change: I congrats on the progress and thanks for taking my questions.
Speaker Change: For the timeline updates and clarifications around timelines, it sounds like it's primarily driven by event rates.
Speaker Change: Can you talk more about whether you have any additional insights into the event rate and whether there could be a relationship with patient baseline characteristics? And just want to clarify if any of the shift was related to enrollment going slower than expected.
Speaker Change: Hi Mari, thanks for your question. We think that as we updated last quarter, our last update, that the higher proportion of mutated patients relative to our initial projection, you know, 40% versus 35%,
Speaker Change: had a corresponding decrease in the rate of enrollment for the wild-type population.
Speaker Change: We factored that into the event projection or the timeline we provided in August and so the recent update relates to
Speaker Change: and would only be a result of the rate of events occurring.
Thank you.
Speaker Change: and so not related to change in enrollment. We're actually a little ahead of where we thought we'd be when we reported in August.
Speaker Change: And so, as far as factors that could drive that, it is really not appropriate for me to comment. I think, you know, the event rate is out of our control, and so it's certainly a function of...
Speaker Change: how the patients are responding to therapies. The events that we can track are only an aggregate for all three arms. We can't track them by endpoint.
Speaker Change: So, we really have limited ability to do anything other than track them and try to forecast when we think we'll cross over the line for those two primary endpoints.
Speaker Change: Okay yeah that makes sense and that's that's helpful and also just wanted to ask you a question
Just based on
Speaker Change: The treatment landscape evolving with Roche's approval of Invalisib in combo with palmiticolab and plifesterin.
Speaker Change: Just your thoughts on that for the frontline setting and how that approval could impact or affect use of gadolazib in the second line if approved for the mutation population.
Sure. Well, we think the study and the results were...
Speaker Change: supportive of our hypothesis, which is that inhibition of all three of these pathways is beneficial and can significantly improve outcomes for patients. As far as the impact on Getta, you know, our current indication, or the indication we'd be seeking, is for patients who are endocrine treatment sensitive, and these are patients who will have received...
Speaker Change: approval for enivalisib to essentially compromise or reduce the population that we're treating in the second line.
Speaker Change: Our Victoria 2 study, though, will directly address the population that the Roche study was focused on, the Invalisib study, except that our study will capture
Speaker Change: will enroll, and 100% of the eligible patients were endocrine treatment resistant, whereas the Roe study essentially only enrolled or treated what we estimate to be roughly 20% of the eligible of the patients who would be considered to be endocrine treatment resistant.
Thank you.
Speaker Change: Okay, that's helpful. Thanks for taking my questions. I'll have back in the queue. You're welcome
Thank you. Thank you.
Speaker Change: Your next question is from Brad Canino from Stifel. Please go ahead.
Brad Canino: I'd just like to ask if you consider these to be potential new combination therapies that could compete with Getatol Sib, and what are you keeping in mind as you plan to analyze the data from those at the meeting? Thank you.
Speaker Change: Sure. Well, at the San Antonio conference, we'll have a number of objectives. I mean, one of them will be to present three posters and update folks on, you know, the extended follow-up we've performed on the patients who were enrolled in.
Speaker Change: the phase 1b study and then you know continue to provide information that helps people understand the mechanism and of GATA and its impact on key metabolic functions.
Speaker Change: We'll also have objectives just related to general activities to support our two ongoing studies in breast cancer.
Speaker Change: But of course, you know, we'll be tracking the data that comes out, you know, the phase three data for the oral CERD and then the other data. Most of these studies are going, seeking to treat a population similar to ours, so certainly very relevant to us and we'll, you know, continue to do that.
Thank you.
review the data accordingly. I think
Speaker Change: you have to peel apart the baseline characteristics and depending on how they present the data, you'll need to.
Speaker Change: do an assessment of the subgroups that maybe correspond to the true second-line population that we're addressing, which is patients who...
received a CDK4-6 and an aromatase
Speaker Change: have received prior CDK4-6. And so that patient population is distinct. Some of these trials will be enrolling patients who have not had a CDK4-6 inhibitor.
Speaker Change: that will tend to make it difficult to interpret without assessing the subgroups, those who've received versus those who haven't received CDK4-6 inhibitors.
And then, you know, there's certain characteristics that.
Speaker Change: aren't necessarily representative of the type of population you might enroll in a phase 3 study. You know, for instance, patients with measurable disease versus non-measurable disease or a valuable versus non-valuable tumors. Those factors can can create
Speaker Change: have an impact on the response of patients to therapy. So it's always important when you look at these studies and you try to do a cross-trial comparison to try to normalize the data as much as
Speaker Change: is possible to ensure that you're comparing likes to like to the extent that, you know, the data is available to do that.
All right. Thanks, Brian.
Speaker Change: The next question is from Tara Bancroft from TD Cowan, please go ahead.
Tara Bancroft: Good afternoon and thanks for taking the questions. So I'm hoping to get a better idea of expectations. So first I was hoping you could tell us
Tara Bancroft: absolute MPFS number that you would like to see in the wild-type triplet and doublet to have the highest level of confidence in success in the mutant population as well.
Also related to what Brian asked, my question
Tara Bancroft: for the control arm expectations, you know, given that we have the EMBER 3 data coming up at San Antonio, it would be great to...
to get your view.
Tara Bancroft: on read-through from that, in particular in the control arm, you know, even though it's investigator choice, but it does include Sylvesteran. So, you know, we've talked about this before with the post-Monarch study, but how should we look at how the control arm performs and make any read-through here?
Speaker Change: Well, as far as what we'd like to see, I mean, we'd love to see two years of media fashion.
as well.
Speaker Change: could be considered to have a more favorable prognosis than the patient population that was evaluated in the Phase 1b study. You know, the patients in the Phase 1b study all had visceral disease, no bone-only patients, 20% of the patients had prior chemo.
Speaker Change: and their median duration of treatment, of their prior treatment, was around 13 months.
whereas in the phase 3 study
Speaker Change: We're not enrolling patients who've had prior chemo in the advanced setting.
Speaker Change: where we are enrolling patients who have bone-only disease as long as they have a measurable lytic or lytic-blastic lesion.
And those two factors, again, tend to correlate to...
improved response to targeted therapies.
So, so net-net, you know, we think we have.
Speaker Change: improve the odds of being able to replicate the data in the Phase 1b. And the Phase 1b data, we reported 12.9 months median PFS overall.
Speaker Change: roughly 50% of patients were progression-free who were wild-type at 12 months, whereas 60% on the mutant setting were progression-free at 12 months.
Speaker Change: KOLs we've spoken to as well as the community physicians very kind of uniformly indicated that the three-month median PFS Delta relative to control would be meaningful. Certainly more is better than than that.
Speaker Change: if that's possible. And so, you know, the data will come out and we'll see. Now, as far as, you know, what to think about the control.
Speaker Change: In the past couple years, or three years, there have been four studies, one phase three, two phase three, two phase twos.
Speaker Change: randomized, that have evaluated fulvestrin in patients who've had prior CDK.
Speaker Change: Three of the studies, two of the studies reported 1.9 months median PFS for provesterone, one reported 2.1 months for provesterone, and the other reported 3.5. If you do a straight average or even a weighted average, you know, taking into account the different population sample sizes,
Speaker Change: you find that the average results for fulvestrant in this population is about three months.
where it ranges from two to three and a half.
Speaker Change: We think it would be very unlikely to see a result that was outside those boundaries going forward.
Speaker Change: As far as Ember 3, I think from what I know about the eligibility criteria, they've included patients who are CDK4-6 treatment naive, as well as those who are CDK4-6 naive.
And so it'll make the intent to treat
Speaker Change: MPFS reported, difficult to interpret because for the most part, certainly in the U.S. and really in most of the developed countries.
Speaker Change: Cdk4-6 treatment is standard in the front line so the results for a mixed population won't necessarily be useful for investigators. They'll want to dig into the post-cdk patient results.
Speaker Change: And we'll see. I think it would be unlikely, given the other results that have been reported, that we'd see results outside that two to three and a half month range. But, you know, we'll know in a couple of weeks.
Okay, great. Thank you.
Thank you.
Thank you.
Speaker Change: Your next question is from Chase Knickerbocker from Craig Hallam. Please go ahead.
Good afternoon. Thanks for the questions.
So Brian just maybe
Yes, we're kind of obviously fully enrolled now and
Speaker Change: the first cohort in Victoria 1. Maybe talk me through, obviously you are going to have a lot of similar trial sites in Victoria 2. Talk me through kind of your enrollment expectations for that study now that you have quite a bit of experience with what to expect from a lot of these sites from Victoria 1 and again kind of what you hear from investigators as far as kind of their excitement around Victoria 2 and to give more patience.
Speaker Change: Sure, I think, A, very excited that the sites in Victoria 1 that we wanted to partner with in this study, the Victoria 2 study wanted to, so we're essentially batting I think about a thousand on that front and and we think
You know that
Speaker Change: reflects their experience with GEDA and so that's that's encouraging to us and then the new sites that will be participating
are familiar with the data that we've presented.
Speaker Change: for the Phase 1B. They also are very familiar with the unmet need and the importance of coming up with options for these patients.
I think generally...
Thank you.
Speaker Change: First-line patient studies are considered to be easier to enroll. There are more patients. They tend to have fewer comorbidities that could make them ineligible.
Speaker Change: And so, we think our enrollment rate for Victoria 1 was very, very good relative to what has been reported for other studies, so we're very encouraged by that.
and so
Speaker Change: We think it would be more likely than not that the enrollment rate for Victoria II would be at least as good or likely a little better than Victoria I.
Speaker Change: So, we'll see as we go, but we're on track to selecting the sites, we're on track to conducting the regulatory work that's required outside the U.S. so that we can get those sites activated and begin screening patients.
Speaker Change: and on track to being able to get our first patient by the second quarter. So, you know, so far so good.
Thanks for the question Brian. You're welcome.
Speaker Change: Ladies and gentlemen, as a reminder, should you have any questions, please press the star key followed by the number one
Speaker Change: There are no further questions at this time. Please proceed with closing remarks. Thank you.
Speaker Change: Well, thank you very much for participating in our call today, for your ongoing support. We'll be participating at multiple upcoming investor conferences in November, and I look forward to interacting with many of you soon. I hope you have a great evening.
Goodbye.
Speaker Change: Ladies and gentlemen, this concludes the conference call for today. We thank you for participating and ask that you please disconnect your lines.