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15-05-2025
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Q1 2025 Celcuity Inc Earnings Call
Apoorva Chaloori; Investor Relations; ICR Healthcare Brian Sullivan; Chairman of the Board, Chief Executive Officer, Co-Founder; Celcuity Inc Vicky Hahne; Chief Financial Officer; Celcuity Inc Maury Raycroft; Analyst; Jefferies Unidentified Participant Tara Bancroft; Analyst; TD Cowen Gil Blum; Analyst; Needham & Company Oliver McCammon; Analyst; LifeSci Capital Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity first-quarter 2025 financial results webcast conference call. (Operator Instructions)I would now like to turn the conference over to Apoorva Chiluri with ICR Healthcare. Please go ahead. Apoorva Chaloori Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Celcuity's First Quarter 2025 Financial Results and Business Update. Earlier today, Celcuity Inc. released financial results for the first quarter ended March 31, 2025. The press release can be found on the Investors section of Celcuity's me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, 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 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 that 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 with that, I would now like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead. Brian Sullivan Thank you, Apoorva. Good afternoon, everyone, and thank you for joining our first quarter financial results conference call. We have an exciting year ahead of us with multiple upcoming clinical data readouts. We expect to report top line data from the PIK3CA wild-type patient cohort of our Phase III VIKTORIA-1 trial in Q3 2025 and from the PIK3CA mutated patient cohort in Q4 2025. We also anticipate reporting preliminary top line data for the Phase Ib portion of our Phase Ib/II trial in prostate cancer in late second finally, we made great progress activating trial sites for our Phase III first-line VIKTORIA-2 trial over the past few months. In our view, each of our 3 programs has the potential to generate significant levels of revenue. If these programs ultimately result in regulatory approvals, we estimate that nearly 200,000 late-stage cancer patients globally would be eligible to be treated with gedatolisib. Let's turn now to our VIKTORIA-1 trial. Our Phase III VIKTORIA-1 trial is designed to evaluate gedatolisib in combination with fulvestrant with and without palbociclib in patients with hormone receptor positive HER2-negative advanced breast cancer, whose disease has progressed on or after treatment with a CDK4/6 VIKTORIA-1 trial includes 2 patient cohorts with independent statistical analysis plans and primary endpoints. The primary endpoints for VIKTORIA-1 are progression-free survival or PFS as assessed by blinded independent central review. Study is designed to independently evaluate a PIK3CA wild-type cohort and a PIK3CA mutant cohort. For the PIK3CA wild-type cohort, there are 2 primary endpoints that will be tested hierarchically, whereas the PIK3CA mutant patient cohort has a single primary endpoint. The primary analysis for each patient cohort is triggered upon reaching a predefined number of progression based on the current blinded event rates, we anticipate the primary completion of the PIK3CA 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 medical conference later in 2025. 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, gedatolisib in combination with fulvestrant and palbociclib could offer a new standard of care for patients with HR-positive/HER2-negative advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor. For the PIK3CA mutant patient cohort, we anticipate reporting top line data in the fourth quarter of 2025. The current second-line treatment paradigm for HR-positive/HER2-negative patients with advanced breast cancer includes selective estrogen receptor degraders or SERDs, like fulvestrant or elacestrant as single agents or 1 of 3 approved PAM inhibitors combined with endocrine each of the PAM inhibitors only targets a single PAM node, such as PI3K alpha, AKT or mTORC1, which is suboptimal because the uninhibited PAM nodes can induce compensatory resistance. In patients who've received prior treatment with the CDK4/6 inhibitor, none of these single node PAM inhibitors have demonstrated efficacy in patients who have PIK3CA wild-type tumors, while only the PIK3CA alpha and AKT inhibitor have reported benefit in patients with PIK3CA mutations. And these results are consistent with the nonclinical data that shows these single node inhibitors are 3 to 4 times less potent in breast cancer cells without PIK3CA mutations than in those with them. Of course, we recognize the foundation of gedatolisib's role in this treatment landscape will require that gedatolisib 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. Breast cancer KOLs and regulators generally consider an incremental improvement in PFS of 3 months relative to its control to be clinically MPFS or median progression-free survival benchmarks for patients pretreated with a CDK4/6 inhibitor patient population we're evaluating are modest. Only 2 non-chemo-related therapies have been evaluated in this patient population and received approval. One reported a 1.9 months incremental median PFS improvement relative to its comparator in patients with ESR1 mutations. The other did not report median progression-free survival improvement relative to current standard of care, but it did report a more favorable safety profile in patients with PIK3CA mutations. Despite the modest or no efficacy improvements on this benchmark, both of these recently approved drugs has experienced rapid market adoption and drug reached revenue run rates within the first 12 months of launch estimated to be nearly $0.5 billion despite approvals that only address 30% to 40% of the eligible second-line patient population. We believe this demonstrates the significant interest amongst oncologists for new treatment options for these patients and the relatively low bar required to obtain adoption and market penetration. A potentially more important data point than incremental PFS benefit to consider in advanced breast cancer when assessing the clinical benefit of one therapeutic regimen relative to another is the hazard ratio. And this is because recent randomized studies evaluating therapies for patients with HR-positive/HER2-negative advanced breast cancer have enrolled widely heterogeneous patient populations. Since physicians make different treatment decisions for patients depending on, among other factors, how many lines of therapy, how well they respond to 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 for incremental PFS benefit a result, top line and PFS results from these studies don't provide sufficient clarity about the actual benefit a particular patient population may receive. The hazard ratio essentially factors out the differences in study populations and thus provides physicians with a more objective benchmark. We 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 CDK4/6 inhibitor. If gedatolisib ultimately does receive FDA approval for both the PIK3CA wild-type and mutant populations, we estimate the peak revenue potential for the second-line indication could exceed $2 billion with just 40% market penetration. I'd like now to turn to our first-line breast cancer program and our VIKTORIA-2 VIKTORIA-2 study is a global Phase III open-label randomized clinical trial, evaluating the efficacy and safety of gedatolisib in combination with fulvestrant plus investigator's choice of either ribociclib or palbociclib as a first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer, and these patients are endocrine therapy resistant. Approximately 638 subjects will be assigned to a cohort based on their PIK3CA mutation status. The primary PFS endpoint for each of the cohorts will be evaluated independently. Prior to initiation of the Phase III portion of the trial, a safety run-in study will be conducted in 12 to 36 participants to assess the safety profile of gedatolisib in combination with ribociclib and fulvestrant. 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 also begun screening patients and expect to dose our first patient during the second quarter. Current standard of care first-line treatment for most endocrine therapy-resistant patients includes any of the 3 approved CDK4/6 inhibitors combined with fulvestrant. Results from a recent trial suggest that the median PFS period for patients receiving 1 of these 3 regimens is only 7 to 8 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 who receive a similar regimen, highlighting the significant need for more effective therapies for patients with advanced breast cancer that are resistant to endocrine therapy. Now I'd like to turn to our Phase Ib/II trial that's evaluating the safety and efficacy of gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer whose disease progressed while receiving a next-generation androgen receptor Phase Ib/II study evaluates gedatolisib in combination with darolutamide, which is an androgen receptor signaling inhibitor in patients with metastatic castration-resistant prostate cancer. We've completed enrollment of the Phase Ib dose escalation portion of the study and anticipate reporting top line data by the end of the second quarter this year. Since we're at an earlier phase in this program, our focus is optimizing the dose and schedule for this tumor type and drug combination. This data set will include approximately 36 patients, half of whom will have received a 120-milligram dose of gedatolisib, the other half a 180-milligram dose. Each are administered on a 3-week on, 1-week off we're comparing both the landmark PFS at 6 months and safety profile of these 2 arms to each other and to historical control data for second-line metastatic castration-resistant prostate cancer patients who are retreated with an androgen receptor inhibitor. 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 gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer. The rationale to initiate the study is based on compelling historical clinical data that indicates women with ER-positive or type 1 endometrial cancer may benefit from treatment with a PI3K/AKT/ mTOR inhibitor like gedatolisib in combination with endocrine therapy. Additionally, results from a prior Phase II clinical study evaluated gedatolisib as a monotherapy in patients with either type 1 or type 2 endometrial cancer, and these results were encouraging. So I'd like now to turn the call over to Vicky to review our finances. Vicky Hahne Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the first quarter of 2025. Our first quarter net loss was $37 million or $0.86 per share compared to $21.6 million net loss or $0.6 per share for the first quarter of 2024. Our non-GAAP adjusted net loss was $34.7 million or $0.81 per share for the first quarter of 2025 compared to non-GAAP adjusted net loss of $19.9 million or $0.59 per share for the first quarter of 2024. Research and development expenses were $32.2 million for the first quarter of 2025 compared to $20.6 million for the first quarter of the approximately $11.6 million increase in R&D expenses, $5.9 million was related to increased employee and consulting expenses and $5.7 million primarily related to activities supporting our ongoing clinical trials. General and administrative expenses were $3.9 million for the first quarter of '25 compared to $1.8 million for the first quarter of 2024. Increased employee and consulting-related expenses accounted for $1.6 million of the increase. Professional fees, expanding infrastructure and other administrative expenses accounted for the remaining increase of approximately $0.5 million. 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 ended the quarter with approximately $205.7 million of cash, cash equivalents and short-term investments. We expect this cash, cash equivalents and short-term investments and drawdowns on our debt facility to fund current clinical development program activities through 2026. I will now hand the call back to Brian. Brian Sullivan We're now ready to turn the call over for questions. Operator (Operator Instructions) Maury Raycroft, Jefferies. Maury Raycroft Congrats on the progress. was going to ask one on VIKTORIA-1. You're using the blinded independent central review analysis, which can take a longer amount of time to analyze versus investigator assessed. And 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 in 3Q. Just wondering if you can give more perspective on the amount of time there. Brian Sullivan Sure the primary completion date essentially is referencing the data cutoff date when you stop collecting data, and that's typically done and in our case, will be done when you've achieved the prescribed event threshold. And so from there, you are engaged in the data cleaning process and ultimately, at that point, you lock the database. So we expect that in Q3, and we're -- if we achieve what we're very confident about achieving with completing the -- achieving the primary completion date, we think that Q3 is absolutely certain time when we would have the data available. And we're not going to get into more specificity in terms of month. But again, I think there's no further risk of delay at this point in the trial of being able to report these results. Maury Raycroft Understood. But I guess for that amount of time from locking the database to reporting the data, any general estimate on how long that could take? Brian Sullivan I mean, typically, you would see no more than 3 months and typically less than that. Maury Raycroft Got it. Okay. And then understanding that 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 that you're seeing between the 3 arms at the data readout? Brian Sullivan The data readout that we expect to make in a press release will only include the median PFS and the hazard ratios for the 2 primary analyses. The subsequent data will be analyzed rather presented at the medical conference later in the year. Operator Andrew Berens, Leerink. Unidentified Participant This is [Elison] on for Andy. I wanted to get your thoughts on the potential impact of SERENA-6 on the second-line setting for HR-positive patients. Just curious what could broad adoption from this need for GEA in the wild-type population? And also kind of a similar question, what could the potential impact be to GA in the mutant patient population as well? Brian Sullivan Sure. Well, we don't think that would affect us at all. These are still essentially first-line CDK4/6 patients. It's actually current practice amongst many doctors, depending on the profile of their patients to transition them off letrozole to fulvestrant 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 the patients in our trial are essentially consistent with the patients that this trial evaluated, which are patients who received CDK4/6 and eventually progressed. And so if our data is favorable, we would expect physicians to then seek to continue treatment with the CDK4/6 inhibitor with one that includes gedatolisib. And I don't think the practice will vary between those patients who lack PIK3CA mutations versus those who do have PIK3CA mutations. I think the primary effect may be on how other CDK4/6 plus oral SERD combinations get Operator Tara Bancroft, TD Cowen. Tara Bancroft So I was wondering if you could provide any updated thoughts on what minimum HR you would consider to be good data in the wild-type update, not just for hitting stats, but in relation to other data sets and indication like SERENA-6 that was just mentioned and other marketed products? And what do KOLs want to see in order to use it? Brian Sullivan No, I appreciate the question. At this time, with the data fairly imminent, we're not going to comment specificity about those types of projections. We've commented because the analysis is easier to do that an incremental 3 months would be considered clinically meaningful. Certainly, any statistically significant hazard ratio that's consistent with 3 months would also be considered clinically meaningful. How the regimen and the results specifically stack up against other regimens will just be a function of how those 2 sets of data compare. Operator (Operator Instructions) Gil Blum, Needham & Company. Gil Blum So just to fully clarify this, what exactly drove the slight change in timing for the wild-type readout? And should we expect to see no change in the PIK3CA time line? And as a follow-on, what investment, if any, would you need to do to support the endometrial cancer collaboration? Brian Sullivan Sure. As far as what drove it, again, I think we've indicated on prior calls that because this is a 3-arm trial and the primary analysis is driven by reaching an event threshold in each of 2 different analyses, it's imprecise for us to estimate the timing. I think there's this variance in how those results are distributed within the aggregate total of events for all 3 arms. And we're now at a point where the potential for variability is de minimis. And so that's why we have confidence about being able to establish a data cutoff in as far as Q4 for the PIK3CA mutant, we're confident about that. It's a less complicated tracking of event threshold because even though the 3 arms, the third arm comprises only about 15% of the total. So the primary analysis event threshold is much more closely aligned to the aggregate of the 3 arms. And as far as the endometrial study that we announced, we are supplying drug product and providing clinical support to that study. So we don't think we'll have any incremental financial effect on the Operator Oliver McCammon, LifeSci Capital. Oliver McCammon Maybe we'll take a break from VIKTORIA-1 for a moment. I'm curious if you can just remind us on some of the prior proof-of-concept data for targeting the PI3K/AKT/MO4 pathway in prostate cancer. And more specifically, what you think the potential is for multi-node inhibition versus single node inhibitors like capivasertib. And then I'm also curious if you plan to share PSA data at the time of the update late in the second quarter. Brian Sullivan Sure. And so the data that's been reported with either in particular, AKT inhibitors, those have been the inhibitors from this general class of drugs that have been evaluated in patients with metastatic castration-resistant prostate cancer. Now capivasertib reported positive data with patients who have hormone-sensitive prostate cancer that was favorable in patients who have P10 mutations, and so a subgroup of the total population. The nonclinical data that we've reported and published indicate the GE is equally active independent of the status of P10, which is the primary mutation in prostate cancer. And capivasertib hasn't demonstrated activity or it's significantly less active in tumor cells, prostate tumor cells that lack P10 so we think that data is encouraging because it demonstrates the role the pathway plays. And similar to breast cancer, gedatolisib in nonclinical models has shown to be significantly more potent and cytotoxic than, let's say, an AKT inhibitor like capivasertib or the other drugs that have been approved that address the PAM pathway. And so that was a major part of the rationale for evaluating GEA in this setting that, a, the pathway has been demonstrated to be approved; and b, the drugs that have demonstrated activity are at least nonclinically, less active than GEA, which we think creates a very strong rationale for the trial. 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 at a medical meeting in 2025. Operator There are no further questions at this time. Please continue, Mr. Brian Sullivan. Brian Sullivan Well, thank you. We appreciate your interest in Celcuity, and we'll be attending and presenting at several investor conferences over the next few weeks. So I look forward to seeing some of you there. Goodbye. Operator Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
07-05-2025
- Business
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Celcuity Inc. Schedules Release of First Quarter 2025 Financial Results and Webcast
Celcuity Inc. MINNEAPOLIS, May 07, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the first quarter 2025 after the market closes on Wednesday, May 14, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call Information To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: A replay of the webcast will be available on the Celcuity website following the live event. About Celcuity Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR ('PAM') pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at . A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is currently recruiting patients. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at . Follow us on LinkedIn and Twitter. View source version of release on Contacts: Celcuity Inc. Brian Sullivan, bsullivan@ Vicky Hahne, vhahne@ (763) 392-0123 ICR Healthcare Patti Bank, (415) 513-1284
Yahoo
24-03-2025
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Celcuity Inc. Schedules Release of Fourth Quarter and Full Year 2024 Financial Results and Webcast/Conference Call
MINNEAPOLIS, March 24, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the fourth quarter and full year 2024 after the market closes on Monday, March 31, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call Information To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: A replay of the webcast will be available on the Celcuity website following the live event. About Celcuity Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at Follow us on LinkedIn and Twitter. View source version of release on Contacts: Celcuity Inc. Brian Sullivan, bsullivan@ Vicky Hahne, vhahne@ (763) 392-0123 ICR HealthcarePatti Bank, 513-1284
Yahoo
25-02-2025
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Celcuity to Participate at Upcoming Cowen and Leerink Investor Conferences
MINNEAPOLIS, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences: A fireside chat at the TD Cowen 45th Annual Health Care Conference in Boston at 10:30 a.m. ET on Tuesday, March 4, 2025. A live webcast will be available using this weblink: and A fireside chat at the Leerink Global Healthcare Conference 2025 in Miami at 9:20 a.m. ET on Wednesday, March 12, 2025. A live webcast will be available using this weblink: About Celcuity Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at Follow us on LinkedIn and Twitter. View source version of release on Contacts: Celcuity Inc. Brian Sullivan, bsullivan@ Vicky Hahne, vhahne@ (763) 392-0123 ICR HealthcarePatti Bank, 513-1284Sign in to access your portfolio