CELC

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 4:30 p.m. ET Chief Executive Officer and Cofounder - Brian F. Sullivan Chief Financial Officer - Vicky Hahne Chief Medical Officer - Igor Gorbachevsky Chief Commercial Officer - Eldon C. Mayer Corporate Communications and Investor Relations - Jodi Sievers Need a quote from a Motley Fool analyst? Email [email protected] Operator: Good afternoon, ladies and gentlemen. Welcome to Security second Quarter 26 Financial Results Conference Call and Webcast. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press 0 for the operator. I would now like to turn the conference over to Jodi Sievers, corporate communications and investor relations at Celcuity. Please go ahead. Jodi Sievers: Thank you, Ludi, and good afternoon to everyone. Thank you for joining us today to read Celcuity's second quarter 26 financial results and business update. Earlier today, Cellcuity released financial results for the quarter ended 06/30/2026. The press release can be found on the Investors section of Celcuity's website Joining me on the call today are Brian F. Sullivan, Celcuity's Chief executive officer and cofounder Vicky Hahne, chief financial officer as well as Igor Gorbachevsky, chief medical officer; and Eldon C. Mayer, chief commercial officer, who will be available during Q&A. As 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 and results may differ materially from those projected in the forward looking statements. Such forward looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected. On this call, we will also refer to non GAAP financial measures. These non GAAP financial measures are used by management to make strategic decisions forecast future results, evaluate the company's current performance. Management believes the presentation of these non GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non GAAP financial measures to the GAAP measures in today's press release and with the And with that, I would like to turn the call over to Brian F. Sullivan, CEO of Cellcuity. Operator: Please go ahead, Brian. Brian F. Sullivan: Thank you, Jodi, and good afternoon, everyone. Thank you for joining our second quarter 26 operating and financial update conference call. Celcuity continues to make monumental progress. Advancing clinical development of gedatolisib for patients with HR positive, HER 2 negative advanced breast cancer. With the FDA approval of Revtopik, positive results from the PIK3CA mutant cohort of our pivotal VIKTORIA-1 study, and a preferred category 1 recommendation in the NCCN guidelines. We are well positioned to address a significant unmet need for the tens of thousands of patients each year by HR positive, HER 2 negative advanced breast cancer. We remain on track to begin shipping Revtopik late in the third quarter of 26 we look forward to making this important therapy available to patients with advanced breast cancer. Based on the positive data from the PIK3CA mutant cohort of the phase 3 VICTORIA-1 study, we plan to submit a supplemental NDA or sNDA in the third quarter of 26. Additionally, our VICTORIA-2 study was expanded to enable evaluation of treatment naive patients who have endocrine sensitive breast cancer. Positioning gedatolisib regimens to potentially be available for nearly all patients in the first line setting. Irrespective of their endocrine sensitivity or PIK3CA status. In sum, we have had an eventful past few months. I would first like to review in a bit more depth the status of our clinical development programs and then provide an update on the commercial launch of Revtopik. On July 14, a few days before our PDUFA date, we received notice from the FDA that Revtopik in combination with filvestrant with or without palbociclib was approved for the treatment of patients with HR positive HER2 negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected. Following progression on or after treatment with at least 1 line of endocrine therapy in the metastatic setting. A little over 2 weeks later, NCCN updated their guidelines for HR positive, HER2-negative breast cancer treatment. Recommending both the Revtopik triplet and doublet regimens as preferred category 1 regimens for second line or subsequent treatment for tumors without a PIK3CA mutation. We are very encouraged by the panel's rapid review and recommendation. In June, we presented positive efficacy and safety results from the PIK3CA mutant cohort of the VICTORIA-1 phase 3 trial at the ASCO annual meeting. Primary efficacy analysis of the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS progression free survival, compared to alpelisib, a PI3K alpha inhibitor, and fulvestrant. Median PFS was 11.1 months with the gedatolisib triplet, versus 5.6 months with alpelisib plus fulvestrant. With a hazard ratio of 0.5 The second end endpoint comparing the gedatolisib doublet versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order. Also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to and fulvestrant. Median PFS was 11.3 months with a gadothelosib doublet, versus 5.6 months with opalifib plus fulvestrant with a hazard ratio of 0.51. The safety data for the gedatolisib triplet and doublet were consistent with previously reported data from the wild type cohort of Victoria 1. Now we have since updated the analyses of the treatment discontinuation rate due to an adverse event for gedatolisib and alpelisib in the PIK3CA mutant cohort using the same methodology that determined the discontinuation rate due to an adverse event with a PIK3CA wild type cohort presented in the Reptarpic label. Patients who received the gedatolisib triplet and gedatolisib doublet, 5.2% and 3.8% of patients discontinued gedatolisib due to an adverse event, respectively. Patients who received alpelisib, 19% discontinued treatment with alpelisib due to an adverse event. Now we believe the lower gedatolisib treatment discontinuation rate for the mutant cohort than was reported in the wild type cohort reflects that the discontinuation rate was higher early in the overall VICTORIA-1 study. And then fell as physicians gained experience. Since a much higher proportion of wild type patients were enrolled during this period, than mutant patients. The impact of this initial higher discontinuation rate early in the study fell disproportionately on the wild type cohort. And thus we believe the treatment discontinuation rate for gedatolisib reported for the mutant cohort roughly 4% to 5%. Best represents what we expect to see in a real world setting. We also updated analyses of the mean number of gedatolisib treatment cycles patients received in the wild type and mutant cohorts of Victoria 1 as of August 2nd 26. And this analysis had a median follow-up period of approximately 21 months for the wild type cohort and 17 months for the mutant cohort. For patients treated with the gedatolisib triplet in the wild type cohort, the mean number of treatment cycles for gedatolisib was 9.0. And 16 of these patients, representing 12% of those dosed. Are still receiving gedatolisib. For those treated with the gedatolisib triplet in the mutant cohort, the mean number of treatment cycles for gedatolisib was 10.0. 34 percent, 34 of these patients, representing 22 percent of those dosed are still receiving gedatolisib. For patients treated with the gedatolisib doublet in the wild type cohort, the mean number of treatment cycles for gedatolisib was 9.7. In 15 of these patients, representing 12% of those dosed, were still receiving gedatolisib. And for patients treated with the gedatolisib doublet in the PIK3CA mutant cohort, the mean number of treatment cycles for patients receiving gedatolisib was 11.3. In 10 of these patients representing 19% of those dosed. Are still receiving gedatolisib. Now analyses of mean treatment cycles for Revtopik in the VICTORIA-1 trial are particularly relevant for assessing the commercial potential of Revtopik since they incorporate the effect that patients who remain on Revtopik for extended periods of time have on the likely usage expected in the real world. The median duration of treatment metric truncates this effect and thus underestimates drug usage for a patient population. We expect to provide further updates to results from both the wild type and mutant cohorts of VICTORIA-1 at medical conferences later in the year. Now with the FDA approval of our NDA in hand and positive data from the mutant cohort, we expect to submit the data from the mutant cohort to the FDA as an sNDA in the third quarter of 2026. And we expect to submit VICTORIA-1 Phase 3 data for both the wild type and mutant cohorts to global regulatory authorities following the sNDA submission. Now the gedatolisib regimens have demonstrated the potential to improve the standard of care in the second line setting regardless of the PIK3CA status of a patient's tumor. And we believe the results from the VICTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K, AKT, mTOR, or PAM pathway. Additionally, these results augur well for the phase 3 VICTORIA-2 trial we have underway to advance development of gedatolisib in the first line setting for patients with advanced breast cancer. In May, we announced that we were expanding the VICTORIA-2 trial to include a second study, study 2, evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in patients with treatment naive endocrine sensitive, HR positive, HER2 negative, advanced breast cancer. And these are women whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy or those with de novo metastatic disease without prior endocrine therapy exposure. Endocrine sensitive patients represent approximately 2-thirds of the women in the US newly diagnosed with advanced breast cancer each year. And current standard of care therapies for these patients provide median progression free survival of approximately 25 months. Study 1 of the VICTORIA-2 trial which was already ongoing, is evaluating gedatolisib in combination with fulvestrant In patients with treatment naive endocrine resistant HR positive, HER2 negative advanced breast cancer. And these are patients whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. Now results from the Phase 1b clinical trial that we ran several years ago provided strong evidence the PAM pathway is an important disease driver in treatment naive patients with advanced breast cancer. In this early phase 1 study, we evaluated gedatolisib plus palbociclib and letrozole as first line treatment in 41 patients with endocrine sensitive HR positive HER2 negative advanced breast cancer. Median PFS was 48.6 months, which compares favorably to historical data of approximately 25 months for ribociclib. Plus letrozole. Ribociclib plus letrozole are the therapy that we are using as the control in our Victoria 2 trial endocrine sensitive patients. The objective response rate was 79% which again compares favorably to historical data of 53% in the first line setting for ribociclib. Plus letrozole. In light of the positive results for the PIK3CA wild type and mutant cohorts in VICTORIA-1, and the promising preliminary data. For gedatolisib triplet as first line treatment, we are optimistic about the results of both our first line studies. Successful development in this first line setting would offer the potential to advance the standard of care for the approximately 90 thousand women each year who are diagnosed with late stage HR positive, HER2 negative advanced breast cancer in The US. Irrespective of their endocrine sensitivity or PIK3CA status. Our advancement of subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gadatholicit. Subcutaneous formulation is aimed at supporting potential future indications for gadgets elusive regimens that may result in a duration of treatment periods greater than several years. And now let's turn to our Phase 1b/2 trial, that is evaluating gedatolisib in combination with darolutamide. In men with metastatic castration resistant breast prostate cancer. In the dose finding portion of the Phase 1b study, evaluation of a 240 milligram dose of gedatolisib was completed. No adverse events led to treatment discontinuation of gedatolisib, and dose-limiting toxicity criteria for dose reduction were not met. And this allowed us to begin evaluation of a 300 milligram dose, which is ongoing. The dose finding portion of the study is completed, we expect to select to select 2 potential recommended phase 2 dose levels and control arm options for the randomized phase 2 portion of the study. We expect to provide updated clinical data and additional visibility into our development strategy for prostate cancer during the fourth quarter of 26. Now I would like to discuss our launch plans and the commercial opportunity for Revtopik. We began laying the groundwork for a potential gedatolisib launch over 24 months ago. And during this period, we have engaged over 1 thousand key opinion leaders and community breast cancer experts over 250 key accounts, major oncology organizations, including GPOs, state societies, and special interest groups, as well as patient advocacy groups. Our unbranded marketing campaign at pampathway.com has already driven awareness of the PAM pathway with metrics tracking well ahead of industry benchmarks. CME and third party peer to peer programs and regional events have further increased levels of awareness about the unmet need in the second line setting. Now the build out of the commercialization infrastructure needed to support successful launch of Revtopik is now complete. And commercial launch activities for Reftapik commenced immediately after approval. Our 80 oncology sales specialists, who have an average of 24 years of industry experience are calling on physicians, and supporting installation of Revtopik order sets within the electronic health record systems of their accounts, and in servicing infusion centers and pharmacies. Our strategic accounts, payer reimbursement, medical liaison, and KOL focused teams are following through on the groundwork they laid prior to Revetorpic approval. Payer and strategic account pathway dossiers have been submitted, and formal efforts to get included on formularies and pathways are in process. All of these efforts are designed to offer patients and providers with rapid access and seamless support. Shipments of Revtopic are expected to begin late in the third quarter of 26. Now wholesale acquisition cost or WACC of Reptarpic which has been reported to the drug pricing compendia, will be $10 thousand per vial or $30 thousand per cycle of treatment. Once Revtopik is commercially available, to enable treating physicians to obtain gedatolisib on behalf of their eligible patients prior to commercial availability of Revtopik, Celcuity opened an expanded access program last week. And shipments to these physicians have begun. Based on analysis of published epidemiological data, we estimate there are 37 thousand patients in The US receiving second line treatment for HR positive HER 2 negative advanced breast cancer. Assuming an average of roughly 10 cycles of treatment, for Revtopik per patient at the WACC price, we estimate the total addressable market for Revtopik in the wild type and mutant setting combined is potentially over $6 billion annually. And that concludes my remarks. I would now like to hand the call over to Vicky, to review our finances. Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I will provide a brief overview of our financial results for the second quarter of 26. Our second quarter net loss was $78.9 million or $1.44 per share compared to a net loss of $45.3 million or $1.04 per share for the prior year period. Our non GAAP adjusted net loss was $58.7 million or $1.07 per share for the second quarter of 26 compared to non GAAP adjusted net loss of $40.5 million or $0.93 per share for the prior year period. Research and development expenses were $31.1 million for the second quarter of 26. Compared to $36.4 million for the prior year period. The $5.3 million decrease was primarily due to a $7 million decrease in clinical trial costs which was primarily driven by decreased costs for the VICTORIA-1 phase 3 clinical trial. The remaining decrease was primarily due to a $5 million decrease in license milestone costs partially offset by a $3.8 million increase in employee related and consulting expense and $2.9 million increase in manufacturing and other costs. Selling, general, and administrative expenses were $35 million for the second quarter of 26. Compared to $7.6 million for the prior year period. The $27.4 million increase was primarily due to a $14.5 million increase in employee related expenses largely driven by the hiring of additional personnel within our commercial function to support the anticipated launch of Reptorpic. The remaining $12.9 million increase was primarily due to a $10.8 million increase in costs to support pre commercial launch activities including consulting expenses, professional fees, and expanding infrastructure costs. And a $2.1 million increase in other administrative expenses. In aggregate, $23.4 million of the $27.4 million selling, general, and administrative increase related to commercial headcount additions and other launch related activities. Net cash used in operating activities for the second quarter of 26 was $55.4 million compared to $36.2 million for the prior year period. The additional cash used in operating activities quarter-over-quarter of $19.2 million was primarily due to non GAAP adjusted net loss of $18.2 million and working capital adjustments of $1 million Cash, cash equivalents, and short term investments were $754 million as of 06/30/2026, compared to $441.5 million as of 12/31/2025. The $312.5 million increase was primarily driven by the convertible note offering completed in June 2026. This resulted in gross proceeds of $575 million and net proceeds of $557.2 million The proceeds were offset by a $137 million repayment of our term loan and $110.5 million cash used in operating activities. Additional cash provided by financing activities of $2.8 million was primarily driven by proceeds from the exercise of common stock options and employee stock purchases. We expect cash, cash equivalents, and investments to finance our operations at least into 2029. I will now hand the call back to Jodi. Jodi Sievers: Operator, could you please open the call for questions? Operator: Thank you. And ladies and gentlemen, we will now begin the you may press star followed by the number 1 on your telephone keypad. To withdraw your question, please press star followed by the number 2. 1 moment, for your first question. And your first question comes from the line of Tara Bancroft with TD Cowen. Please go ahead. Tara Bancroft: So I guess what I would really like to understand is more of what underscores your confidence in the late Q3 shipments. Like, for instance, are you initially launching with the existing clinical supply? And if so, how long would that last you? And, you know, how long is the process for setup with the backup manufacturing and what does that entail? I know that sounds like a lot of questions, but I am just getting at the same thing of your level of confidence supplying the launch without delay. Brian F. Sullivan: Sure. As I explained, you know, last, couple weeks ago, I mean Mhmm. You know, we want to have confidence that our review process with the FDA will proceed according to what we expect to occur, that there are no surprises. And we are very confident about being able to ship beginning at the end of this quarter. So nothing's changed. Tara Bancroft: Okay. Brent. And I guess just as a follow-up, as part of that review process, do you need an inspection? Brian F. Sullivan: Well, the FDA can do whatever they want. But, typically Yeah. If you are with a manufacturer that has met requirements, They do not necessarily require that. It would again, you do not want to really be in the position of projecting what the FDA, you know, does or will not do. But we believe the validation data that we have is very consistent with the validation from our first site. And so we would anticipate that the review process will be straightforward. Tara Bancroft: Okay. Great. Thanks so much. You are welcome. Operator: And your next question comes from the line of Maury Raycroft with Jefferies. Please go ahead. Maury Raycroft: Hi. Congrats on the progress. Thanks for taking my questions. I will follow-up on Tara's questions. Just wondering if you can clarify if you submitted that validation work, the necessary information to FDA yet. Or what are the rate limiting steps remaining there. And do you need FDA to provide any type of sign off before you can launch with products in that site? Brian F. Sullivan: Well, 2 things. We submitted the data almost immediately after we got the approval. We had, validation, the package of information required to get the FDA to review and for approval for the use of that site. So that is begun. And you cannot ship from that new site until you have received the go ahead from the FDA. that is the limitation on getting access to material from that second site. But again, as we have indicated, we want visibility on the review process for that site. And, again, we are confident about our ability to ship on the third quarter. Late third quarter. Maury Raycroft: Got it. Okay. Maybe 1 other question just on the expanded access program. Wondering how many sites or doctors are participating in it, and do you have some patients enrolled already? And will you provide quarterly updates, on where you are at with enrollment there? Brian F. Sullivan: I guess, is that something that could Hopefully, we are not providing quarterly updates. Right? Because Yeah. It will go away. But yes. We just, you know, got the program started last week. I mean, essentially, had to get you know, approval, you know, submit to the FDA as well as get IRB approval central IRB approval. So that occurred last week, and we have already begun shipping drug to physician or to sites where physicians are treating patients. Got it. Maury Raycroft: And then presumably, once you have drug launched, then those patients would convert over to commercial drug then. Brian F. Sullivan: Exactly. And that was reflected in the protocol. Got it. Maury Raycroft: Okay. Okay. Thanks for taking my questions. You are welcome. Operator: The next question comes from the line of Brad Canino with Guggenheim. Please go ahead. Brian F. Sullivan: Hey, Bradley. Brad Canino: Thanks for the update, especially around the prostate cancer progress. it is good to hear I am actually wondering about a different cancer center because I know 1 of your competitors in the space is doing a lot of work in endometrial cancer. And I am wondering how you think about that as an opportunity for gedatolisib. I know there is probably some old data that Pfizer conducted, probably not the right regimen and treatment line and setting, etcetera. So how do you think about bringing that into the development portfolio if that is an opportunity for you guys? Thank you. Brian F. Sullivan: Sure. there is certainly a strong rationale for us to consider that, and, you know, we will be updating folks on our, excuse me, our development plans as we get further into the year. But until then, I can simply say that some preliminary data that was generated previously was indicating that even as monotherapy, GEDA can induce a objective response. And you know, the underlying drivers of the disease include the role of the PIK3CA pathway, and for a certain significant cohort, the endometrioid patient population. The hormonal pathway is also involved. So there is certainly a strong rationale. For us to consider developing, in that setting. Right. Brad Canino: And then in prostate specifically too, I am tracking this somewhat from afar, and I am hearing KOLs have a pretty intense conversation around capivasertib and its potential role there. As the first inaugural pathway inhibitor on the PAM pathway to go after that. What do you think as you have the conversations with those same investigators and KOLs, we can actually learn from the capivasertib data and how it has a foreshadow of the opportunity for something like gedotolitinib? And what should we keep in mind that could be different for gedatolisib as you approach it? Thank you. Brian F. Sullivan: Sure. So capivasertib, as you know, is approved in breast cancer to treat patients who have a PIK3CA mutation. Its efficacy was comparable to the efficacy for alpelisib in its phase 3 study. In a similar setting as what we were just studying and gedatolisib as we, you know, announced recently. Showed double the activity relative to alpelisib, which we think is a reasonable proxy for what capivasertib is capable of doing. And so we think the fact that capivasertib, got an approval for the PTEN loss population, essentially, that is the most relevant mutation of the PAM pathway in prostate cancer. And so, that drug is limited to that roughly 40% of patients with 10 loss. But we think it augurs well for us. They are evaluating-- rather they got an approval, in patients who are at an earlier stage than the patients we are evaluating. They are evaluating hormone sensitive prostate patients. You know, we are evaluating castration resistant patients. But the fact they got off the line with a positive study in a mutant cohort similar to what they did in breast cancer, we think it is translatable to what we may be able to do. We have encouraging data. We will be updating that data later this year. And we believe, you know, that they demonstrate that this pathway, the PAM pathway, plays a role as a driver. And that when combined with an androgen receptor inhibitor, you can induce an improvement in outcomes relative to androgen receptor alone. And that is ultimately our hypothesis. We are we are going to be evaluating that in a different setting. But it certainly provides another demonstration of the importance of the pathway in this disease. Okay. Thanks, Brian. You are welcome. Operator: Your next question comes from the line of Eva Fortea-Verdejo with Wells Fargo. Please go ahead. Eva Fortea-Verdejo: Hi, team. Congrats on the progress, and thanks for taking our question. A quick 1 from us on the EAP. Can you provide more color on how long do you expect it will take to transition the patient from the EAP to commercial following the launch in late Q3? Brian F. Sullivan: You know, I do not wanna get committed to a particular timeline. I mean, certainly, we have to be very sensitive to the needs of the patient and make sure that, you know, there is no risk of interruption in supply. And so you know, again, it could be very site specific, patient specific you know, depending on their insurance situation and other factors. That may be relevant. But the intent is certainly to transition those patients to commercial supply. that is embedded within the protocol and is well understood. The participating investigators. So, and that is a very standard approach. But again, we would expect that transition to occur. You know, it may occur in that 2 week gap from day 15 to the next cycle of treatment, you know, in effect day 29. But again, the overall goal is to make sure that there is no disruption to the patient's access to the therapy, and we will essentially accommodate whatever might be required to ensure that transition occurs smoothly. Eva Fortea-Verdejo: Got it. Very helpful. Thanks. Operator: And your next question comes from the line of Andrew Berens with Leerink Partners. Please go ahead. Analyst: Hi. This is Isabelle on for Andy. Thanks for taking our question. Wondering if you could give more color on the expected gross to net. Thanks. Brian F. Sullivan: Sure. So we have done an analysis that we think is fairly robust, actually very robust, that kind of identifies the various components of the discounts. And they do not involve discounts to, you know, they do not reflect discounting of the drug per se, but they reflect channel differences that just a function of, you know, the makeup of those channels. But for our drug, we expect a gross to net percentage to be about 80%, the discounts involved From WACC will be about 20%. And based on data we have seen for oral therapies, you know, that gross to net discount can be about 30%. So, you know, so we think we will be able to capture a higher percentage of the WACC than the corresponding oral therapies in this category. Are able to capture. Analyst: All right. Thank you. Operator: And your next question comes from the line of Oliver McCammon with LifeSci Capital. Please go ahead. Oliver McCammon: Maybe just a broader question on the commercialization and your work engaging physicians. But curious what proportion of community oncology practices as you think about associated infusion centers as well as geography you think would be amenable to IV therapy in this setting? And then, relatedly, do you think there are any learnings to take from what we hear is fairly common use of IV administered in HER 2 even in second line? Thanks again. Brian F. Sullivan: Sure. Well, we think nearly every community practice has access to infusion centers because some of the most important therapies in breast cancer used to treat breast cancer are infused therapies. and HER2 was 1 you mentioned, pembrolizumab and TNBC is another. Perceptin or and Perjeta, which are 2 anti HER 2 antibodies. Are also standard of care treatments in advanced breast cancer, HER 2 positive breast cancer. And then all the chemotherapies or many of the chemotherapies that are prescribed are infused. And so, you know, the practice of medicine treating breast cancer patients requires access. To infusion centers. So we do not think there is gonna be any barrier to a community oncologist prescribing gedatolisib and ensuring their patient can get infused. And these docs represent the community treaters, treat about 80% of Excuse me. Operator: Ladies and gentlemen, please continue to stand by. Your conference will resume momentarily. Thank you. Ladies and gentlemen, we will now resume our conference with the technical difficulties. Brian, please go ahead. Brian F. Sullivan: Well, thank you. I hope, you all heard the last answer to my question. Operator, if there is an additional questions, I am happy to answer those. Operator: Oliver, do you still have any additional questions? Alright. Thank you. Your next question comes from the line of Kalpit Patel with Wolfe Research. Please go ahead. Kalpit Patel: Yeah. Hey. Good afternoon, and thanks for taking my question. Just 1 from us on the prostate cancer program. Can you give us a little more granularity on what to expect? In the fourth quarter? Is it just PSA response data, or are we gonna see RPFS data as well? And then what would success look like to you in that area? Thank you. Brian F. Sullivan: Sure. So we expect to provide additional data that could include PSA 50 data as well as updated progression free survival data and looking at different subgroups of patients. As well as data from the 240 milligram dose. As well, the data from the 300 milligram dose may not be mature enough to present. But it will be data that has not been presented before that we think will hopefully shed some good light on the program itself. Kalpit Patel: Okay. And any color on what would be encouraging in your view? For RPFS? Brian F. Sullivan: Well, I think the standard of care today, or rather, I would say, there are kind of 2 components to that answer. Current patients in the second line setting who have progressed on, let's say, prior abiturone, can expect to receive 5 to 6 months median PFS. Similarly, if they are treated with docetaxel as instead of a hormonal therapy. So the minimum bar to beat would be, you know, 3 to 4 months better than those options. Pluvicto's out there as an option as well. They are offering patients, you know, north of 10 months. And so our expectation would be that we would need at least to be comparable to Pluvicto. We think there would be advantages to use of our drug versus their drug. In that setting, and certainly, would hope to be superior to that. But if we are able to demonstrate you know, typical 3 to 4 month superiority relative to you know, what would be an add on therapy with gedatolisib versus a switched androgen receptor inhibitor. At least comparable efficacy to Pluvicto that we could potentially play an important role in that treatment. Of course, you know, we know there is some other data that could be coming down the pike and that will be very relevant, to any assessment, that we make. Kalpit Patel: Okay. that is super helpful. Thank you. You are welcome. Operator: Your next question comes from the line of Gil Blum with Needham. Please go ahead. Analyst: Hi, guys. This is Jonathan on for Gil. A quick question about the secondary manufacturing site. Brian F. Sullivan: For the supplemental filing, what is the timeline that you guys are expecting for hearing back from the FDA? Is it similar to an sNDA timeline? it is not an sNDA. There are multiple processes and steps along the way, but you know, it can involve a review as brief as 2 months or, you know, or 4 months. And, again, if there is issues, which, again, we do not expect to occur, you know, it can take longer. And so, you know, there is a standard process of 4-month review process. It can be shorter. And but, again, you are interacting with the agency during that process, and you will gain an understanding from that initial feedback, you know, what, if any, issues know, they may have or considerations they may be wanting us to address. But that is that is what we think we will find out. Relatively early in the process. Analyst: And just a quick follow-up, if this supplemental filing was approved, what percent of supply would you expect would be coming from the second site at full capacity? You know, that is that is a very tactical. It will be appropriate. We will be using you know, inventory from both sites and, you know, managing. Inventory accordingly. it is important to keep both sites going. it is just you wanna create a rhythm for them. And so you are you are always gonna be balancing. Mix of product yeah, between those 2 sites. Again, and congrats again on all the progress. You are welcome. Operator: And your next question comes from the line of Stephen Willey with Stifel. Please go ahead. Analyst: Yes. Good afternoon. Thanks for taking the questions. Just curious where you are in terms of preparing a publication of the mutant data and whether you believe the compendia listing for use of these patients could be achieved before formal label expansion. And then it was also just wondering how you are thinking about communicating launch progress to the street and metrics you think you might be providing to us over the next few quarters? Thanks. Brian F. Sullivan: Sure. Regarding the article, we have we have submitted an article to journal. And that process is variable in time. It can, you know, take you know, 3 months. It can take 6 months. We would hope to have it be on the shorter range of that timeline, but it is 100% in our control, obviously. But that process is well underway. As far as mutant usage, I mean, we cannot promote the mutant usage. But we would have the opportunity potentially to-- it is up to the NCCN, panels to have the NCCN make a recommendation based on published data. They cannot make recommendations just based on, for instance, a presentation given at a major medical conference They need to see data from a peer reviewed journal. Before they would consider making changes to their recommendations. But if they made recommendations, those are widely followed by payers and if the recommendations are appropriate, what the payers require, then the physicians would be in a position to prescribe the medicine and their patients to get reimbursed for it. But, again, they are not something we can certainly drive or really discuss at all in the clinical context. But those are variables that, you know, could be present in the marketplace. And as far as progress, we will be reporting sales, obviously. As we go. You know, we do not have the granularity of data that you have with oral therapies. You know, we have-- we ship to a site buy and bill, but we do not get a prescriber name on that therapy. And so we do not get as much visibility, there is not a name on the prescription, for instance. So we do not get as much visibility as, let's say, an oral medication gets. So the granularity of data will not be as high as people might be used to for oral therapies. We will be doing survey data that will give us a view on probably 40% to 50% of patients treated, but there will be a lag in that. That will be 2 to 3 months. Lag. So it will not be current or necessarily representative. It will provide us important information to help manage the business. But it will not be a real time evaluation. We internally will be certainly tracking and be able to intuit based on our analyses, you know, where the drug is going, who is at the locations, and be able to do analysis like that. But we will not have the sufficient specificity to, for instance, identify, you know, how many docs prescribed it, how many re prescribed it, how many patients on therapy. You know, we will we will simply have in real time setting. Actual number of vials, shipped to, sites. And we expect that to represent demand. You know, there really will not be inventorying of this drug. Our distributor, our 3PL, will be delivering this drug overnight in a great majority of cases. And so we do not expect and some of the larger sites, depending on their overall approach, you know, may we will provide-- maintain some stock based on the number of patients they have on the drug. So there could be in certain facilities, a little bit of loading, but we would not expect that to represent you know, let's say more than a cycle of treatment. We think that would be unlikely. Alright. that is very helpful. Thank you. You are welcome. Operator: And your next question comes from the line of Silvan Tuerkcan with Citizens. Please go ahead. Josh Boen: Hey. This is Josh on for Silvan. Thanks for taking the question. Yeah. So you mentioned plans to submit the sNDA for the mutant population in March. Could you maybe just walk us through some of the potential regulatory timelines maybe submission to filing and then potential for a priority review period? Brian F. Sullivan: Sure. Yeah. Sure. No. Because it is an sNDA, while they will need to accept the sNDA, the clock starts for the review. When the final submission is made. And so, from the time we complete our submission to whatever the prescribed PDUFA date is would be the expected review cycle. If it is a priority review, it would be 6 months from submission. If it is a regular review, it would be 10 months, from submission. Josh Boen: Great. Thank you. You are welcome. Operator: And I am showing no further questions at this time. I would like to turn it back to our CEO, Brian F. Sullivan, for closing remarks. Brian F. Sullivan: Thank you for participating in our call today, for your ongoing support. And look forward to, seeing you potentially at conferences over the next few months. Take care. Operator: Ladies and gentlemen, this concludes today's conference call. Thank you all for joining. You may now disconnect. Before you buy stock in Celcuity, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Celcuity wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Celcuity (CELC) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

In the second quarter of 2026, Celcuity Inc. reported a wider net loss of US$78.86 million and basic loss per share of US$1.44, even as it prepared for the commercial launch of its newly FDA‑approved breast cancer therapy Revtopik (also referred to as REVTORPYK). The FDA approval of Revtopik for HR‑positive, HER2‑negative advanced breast cancer, combined with its upgrade to Category 1 preferred status in NCCN guidelines and strong VICTORIA‑1 efficacy data, marks a key turning point as Celcuity shifts from a purely clinical focus toward potential commercial revenue. We’ll now examine how Revtopik’s FDA approval and NCCN Category 1 status could reshape Celcuity’s previously pre‑commercial investment narrative. The future of work is here. Discover the 37 top robotics and automation stocks leading the charge in AI-driven automation and industrial transformation. To own Celcuity today, you have to believe Revtopik can move from an FDA‑approved niche product to a meaningful commercial franchise, while the company reins in sizeable losses. The key near term catalyst is the first wave of Revtopik sales once shipments begin, and the main risk is that current operating losses, which widened to a Q2 2026 net loss of US$78.86 million, persist longer than investors are comfortable with. The most relevant recent announcement is Revtopik’s upgrade to NCCN Category 1 preferred status for second line HR‑positive, HER2‑negative breast cancer after endocrine progression. This endorsement, coming shortly after FDA approval, gives Celcuity a guideline foothold that could support the upcoming launch and any future label expansions the company pursues, including the planned supplemental NDA for the PIK3CA mutant population. But with losses increasing and negative equity on the balance sheet, investors should also be aware that... Read the full narrative on Celcuity (it's free!) Celcuity's narrative projects $817.9 million in revenue and $267.5 million in earnings by 2029. This implies an earnings increase of about $460 million from -$192.9 million today. Uncover how Celcuity's forecasts yield a $161.09 fair value, a 75% upside to its current price. Before this approval, the most optimistic analysts were modeling US$1.4 billion of revenue and US$562.1 million of earnings by 2029, so Revtopik’s launch could either validate that ambitious view or prompt a reset in expectations. Explore 4 other fair value estimates on Celcuity - why the stock might be worth over 10x more than the current price! Disagree with existing narratives? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Celcuity research is our analysis highlighting 3 key rewards and 4 important warning signs that could impact your investment decision. Our free Celcuity research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Celcuity's overall financial health at a glance. Every day counts. These free picks are already gaining attention. See them before the crowd does: Find 52 companies with promising cash flow potential yet trading below their fair value. Outshine the giants: these 17 early-stage AI stocks could fund your retirement. Uncover the next big thing with 20 elite penny stocks that balance risk and reward. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include CELC. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Secured FDA approval for Revtopik in HR+/HER2- advanced breast cancer (PIK3CA wild-type) following progression on endocrine therapy. Achieved a preferred Category 1 NCCN guideline recommendation for both Revtopik triplet and doublet regimens shortly after FDA approval. Demonstrated superior efficacy in the PIK3CA mutant cohort of the VICTORIA-1 study, with a median PFS of 11.1 months for the gedatolisib triplet versus 5.6 months for the control. Observed significantly lower treatment discontinuation rates (4-5%) in the mutant cohort compared to the wild-type cohort, which management attributes to increased physician experience with the drug. Expanded the VICTORIA-2 trial to include endocrine-sensitive patients, aiming to position gedatolisib as a potential first-line treatment for nearly all advanced breast cancer patients. Validated the PAM pathway's role in prostate cancer through Phase 1b dose-escalation, showing no dose-limiting toxicities at the 240mg level. Anticipate commercial shipments of Revtopik to commence late in the third quarter of 2026. Plan to submit a supplemental NDA (sNDA) for the PIK3CA mutant breast cancer population in Q3 2026, targeting a potential 6-month priority review. Expect to provide updated clinical data and a defined development strategy for metastatic castration-resistant prostate cancer in Q4 2026. Projecting a total addressable market of over $6 billion annually for Revtopik across both wild-type and mutant settings in the US. Maintaining a cash runway expected to finance operations at least into 2029 following a successful $575 million convertible note offering. Established a Wholesale Acquisition Cost (WAC) of $10,000 per vial or $30,000 per treatment cycle for Revtopik. Launched an Expanded Access Program (EAP) to provide gedatolisib to eligible patients prior to full commercial availability. Completed the build-out of a 80-person oncology sales specialist team to support the immediate commercial launch. Reported a $27.4 million increase in SG&A expenses primarily driven by commercial headcount additions and pre-launch infrastructure costs. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expressed high confidence in late Q3 shipments, noting that validation data for the second manufacturing site was submitted to the FDA immediately post-approval. Confirmed that while they cannot ship from the new site without FDA sign-off, the review process is expected to be straightforward based on existing site validation. Expect a gross-to-net percentage of approximately 80%, representing a 20% discount from WAC. Management noted this is more favorable than the typical 30% discount seen for oral therapies in the same category. Success in the prostate program is defined as achieving at least 3-4 months of PFS superiority over the current 5-6 month standard of care. Management views the approval of capivasertib in PTEN-loss populations as a positive indicator for the PAM pathway's relevance in prostate cancer. Acknowledged that visibility into prescriber-level data is lower for infused drugs compared to oral medications because there is no individual name on the prescription. Will rely on internal tracking of vial shipments to sites and survey data (covering 40-50% of patients) with a 2-3 month lag to monitor demand.

This article first appeared on GuruFocus. Net Loss: GAAP net loss of $78.9 million, or $1.44 per share, for Q2 2026, compared to $45.3 million, or $1.04 per share, in the prior-year period. Non-GAAP Adjusted Net Loss: $58.7 million, or $1.07 per share, for Q2 2026, compared to $40.5 million, or $0.93 per share, in the prior-year period. Research and Development (R&D) Expenses: $31.1 million for Q2 2026, down from $36.4 million in the prior-year period. Selling, General and Administrative (SG&A) Expenses: $35.0 million for Q2 2026, up from $7.6 million in the prior-year period, driven by commercial launch preparations. Cash Used in Operating Activities: $55.4 million for Q2 2026, compared to $36.2 million in the prior-year period. Cash Position: Cash, cash equivalents, and short-term investments totaled $754 million as of June 30, 2026, up from $441.5 million as of December 31, 2025. Product Pricing: Wholesale acquisition cost (WAC) for REVTORPYK is $10,000 per vial, or $30,000 per treatment cycle. Market Opportunity: Estimated total addressable market for REVTORPYK is potentially over $6 billion annually, based on 37,000 US patients receiving second-line treatment. Warning! GuruFocus has detected 2 Warning Sign with CELC. Is CELC fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. FDA approval of REVTORPYK for HR-positive, HER2-negative advanced breast cancer without PIK3CA mutation, with shipments expected to begin late Q3 2026. Positive Phase 3 VIKTORIA-1 results in PIK3CA mutant cohort, showing median PFS of 11.1 months vs 5.6 months for alpelisib, with a hazard ratio of 0.5. NCCN guidelines updated to recommend REVTORPYK triplet and doublet as preferred Category 1 regimens for second-line treatment. Expansion of VIKTORIA-2 trial to include endocrine-sensitive patients, potentially broadening first-line treatment opportunities. Strong cash position of $754 million, expected to fund operations into 2029, supporting ongoing development and commercial launch. Net loss increased to $78.9 million in Q2 2026, up from $45.3 million in the prior-year period, driven by higher SG&A expenses. Commercial launch is dependent on FDA approval for a second manufacturing site, with no guaranteed timeline for review. Gross-to-net discount of approximately 20% from WAC, which may impact revenue expectations. Limited real-time visibility into prescription data due to buy-and-bill model, making it difficult to track launch progress accurately. Potential delays in sNDA submission for PIK3CA mutant cohort, with review timelines of 6-10 months, delaying label expansion. Q: What underscores your confidence in the late Q3 shipments of REVTORPYK, and what is the process for the backup manufacturing site?A: Brian Sullivan, CEO, stated that the company is confident about shipping at the end of Q3 2026. The validation data for the second manufacturing site is consistent with the first site, and the company anticipates a straightforward review process with the FDA. The FDA can require an inspection, but the company believes the review will proceed as expected. Q: Can you clarify if the validation work for the second manufacturing site has been submitted to the FDA, and what are the rate-limiting steps?A: Brian Sullivan, CEO, confirmed that the validation package was submitted to the FDA almost immediately after approval. The company cannot ship from the new site until receiving FDA approval, but remains confident in shipping late in Q3 2026. Q: How many sites or doctors are participating in the Expanded Access Program (EAP), and will you provide quarterly updates?A: Brian Sullivan, CEO, noted the EAP started last week after receiving FDA and central IRB approval. Shipments to physicians have already begun. The company does not plan to provide quarterly updates as the program will transition to commercial supply. Patients will be converted to commercial drug once launched, as reflected in the protocol. Q: How do you think about the opportunity for gedatolisib in endometrial cancer, given competitor activity?A: Brian Sullivan, CEO, acknowledged a strong rationale for considering endometrial cancer, citing preliminary data showing gedatolisib can induce objective responses as monotherapy. The PIK3CA pathway and hormonal pathway are involved in the endometroid patient population, making it a viable development opportunity. The company will update on development plans later in the year. Q: What can we learn from capivasertib's data in prostate cancer, and how does it foreshadow the opportunity for gedatolisib?A: Brian Sullivan, CEO, explained that capivasertib's efficacy in breast cancer was comparable to alpelisib, while gedatolisib showed double the activity. Capivasertib's approval in PTEN loss patients (about 40% of prostate cancer patients) validates the PAM pathway as a driver. The company believes its data, to be updated later this year, will demonstrate that combining gedatolisib with an androgen receptor inhibitor improves outcomes. Q: How long will it take to transition patients from the EAP to commercial drug following the launch?A: Brian Sullivan, CEO, stated the transition timeline will be site- and patient-specific, depending on insurance situations. The goal is to ensure no disruption in supply. The transition may occur during the 2-week gap between treatment cycles, but the company will accommodate whatever is required for a smooth transition. Q: What is the expected gross-to-net percentage for REVTORPYK?A: Brian Sullivan, CEO, expects the gross-to-net percentage to be about 80%, with discounts from WAC of about 20%. This compares favorably to oral therapies in the category, which typically see discounts of about 30%. The company believes it can capture a higher percentage of WAC than oral therapies. Q: What proportion of community oncology practices would be amenable to IV therapy, and are there learnings from HER2 use?A: Brian Sullivan, CEO, stated that nearly every community practice has access to infusion centers because many standard breast cancer therapies (e.g., HER2 antibodies, chemotherapies) are infused. Community oncologists treat about 80% of patients, and there should be no barrier to prescribing gedatolisib. Q: What data should we expect from the prostate cancer program in Q4, and what would success look like?A: Brian Sullivan, CEO, expects to provide PSA50 data, updated progression-free survival data, and subgroup analyses. The 300mg dose data may not be mature. Success would be demonstrating a three-to-four-month superiority over standard of care (five to six months median PFS) or comparable efficacy to PLUVICTO (north of 10 months). Q: What is the timeline for the FDA's review of the second manufacturing site, and what percent of supply would come from it?A: Brian Sullivan, CEO, stated the review process can take two to four months, with interactions with the agency providing early feedback. The company will balance inventory from both sites to maintain a rhythm, but did not specify a percentage split. Q: Where are you in preparing a publication of the VIKTORIA-1 mutant cohort data, and could compendium listing be achieved before label expansion?A: Brian Sullivan, CEO, confirmed an article has been submitted to a journal, with a timeline of three to six months. NCCN recommendations require peer-reviewed data, and if made, payers would likely follow. The company cannot promote mutant usage but could benefit from NCCN recommendations. Launch progress will be reported via sales, though granularity will be lower than oral therapies due to the buy-and-bill model. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

REVTORPYK™ (gedatolisib) approved by the U.S. FDA for the treatment of HR+/HER2- PIK3CA Wild-Type locally advanced or metastatic breast cancer on July 14, 2026; on track for commercial launch late third quarter 2026 NCCN® Clinical Practice Guidelines recommended REVTORPYK in combination with fulvestrant, with or without palbociclib, as a preferred Category 1 option for second-line therapy in HR+/HER2- advanced breast cancer The Phase 3 PIK3CA mutant cohort of the VIKTORIA-1 trial achieved its primary endpoint by doubling the likelihood of survival without disease progression or death compared to alpelisib plus fulvestrant; a supplemental New Drug Application (“sNDA”) is planned for submission in the third quarter of 2026 The Phase 3 VIKTORIA-2 trial was expanded to include a second study evaluating gedatolisib as first-line treatment in patients with endocrine-sensitive HR+/HER2- advanced breast cancer Completed issuance of $575.0 million convertible note offering, with net proceeds of $557.2 million Management to host webcast and conference call today, August 13, 2026, at 4:30 p.m. EDT MINNEAPOLIS, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced financial results for the second quarter ended June 30, 2026 and other recent business developments. “Celcuity made monumental progress these past few months, achieving critical clinical and regulatory milestones related to gedatolisib. With the FDA approval of REVTORPYK, positive results from the PIK3CA MT cohort of the pivotal VIKTORIA-1 study, and a preferred Category 1 recommendation in the NCCN Guidelines®, we are well positioned to address a significant unmet need for the tens of thousands of patients affected each year by HR+/HER2-, locally advanced or metastatic breast cancer whose disease has progressed after endocrine therapy,” said Brian Sullivan, CEO and co-founder of Celcuity. “We are on track to begin shipping REVTORPYK late in the third quarter of 2026, and we look forward to making this important therapy available to patients with locally advanced or metastatic breast cancer.” Mr. Sullivan added, “Based on the positive data from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study, we plan to submit an sNDA to FDA in the third quarter of 2026. Additionally, our VIKTORIA-2 study was expanded to enable evaluation of treatment-naive patients who have endocrine-sensitive breast cancer, positioning gedatolisib regimens to potentially be available for nearly all patients in the first- and second-line setting, irrespective of their endocrine sensitivity or PIK3CA mutation status.” Clinical Highlights HR+/HER2- Advanced Breast Cancer 2nd Line Setting – PIK3CA Wild-Type Following the unprecedented results from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 clinical trial, on July 14, 2026 Celcuity announced that the U.S. Food and Drug Administration (“FDA”) had approved REVTORPYK, the company’s pan-PI3K, mTORC1/2 inhibitor, for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor 2 receptor negative (”HER2-“), locally advanced or metastatic breast cancer (“ABC”) without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Celcuity subsequently announced that REVTORPYK in combination with fulvestrant, with or without palbociclib, was recommended by the National Comprehensive Cancer Network® (“NCCN®”) as a preferred Category 1 second-line and/or subsequent-line therapy for the treatment of patients with HR+/HER2- breast cancer without a PIK3CA mutation following progression on or after treatment with at least one line of endocrine therapy. The build-out of the commercialization infrastructure needed to support a successful launch of REVTORPYK is complete and commercial launch activities for REVTORPYK commenced immediately after approval. Shipments of REVTORPYK are expected to begin late in the third quarter of 2026. To make gedatolisib available to patients prior to commercial availability of REVTORPYK, last week Celcuity opened an Expanded Access Program (EAP) to participating physicians on behalf of eligible patients, and we have begun to distribute gedatolisib to those physicians. 2nd Line Setting – PIK3CA Mutant-Type Gedatolisib continued to demonstrate a differentiated clinical profile across different patient populations when combined with fulvestrant, with or without palbociclib. At the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting, detailed results from the PIK3CA MT cohort of the global VIKTORIA-1 Phase 3 study were presented at a late-breaking abstract Oral Session. The study demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (“PFS”) compared with alpelisib plus fulvestrant, with a manageable safety profile. Gedatolisib plus fulvestrant and palbociclib (the “gedatolisib-triplet”) reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). Median PFS was 11.1 months with the gedatolisib triplet versus 5.6 months with alpelisib plus fulvestrant. Gedatolisib plus fulvestrant (the “gedatolisib-doublet”) reduced the risk of disease progression or death by 49% vs. alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33–0.79; descriptive p=0.0013). Median PFS was 11.3 months with the gedatolisib-doublet versus 5.6 months with alpelisib plus fulvestrant. Gedatolisib regimens demonstrated robust and durable responses: 49% objective response rate (“ORR”) and median duration of response (“DoR”) of 15.7 months for the gedatolisib-triplet and 36% ORR and median DoR of 24.2 months for the gedatolisib-doublet. The safety data for the gedatolisib-triplet and -doublet were consistent with previously reported data from the PIK3CA wild-type cohort of VIKTORIA-1. Analyses of the treatment discontinuation rate due to an adverse event for gedatolisib and alpelisib in the PIK3CA MT cohort were updated using the same methodology that determined the discontinuation rate due to an adverse event for the PIK3CA WT cohort presented in the REVTORPYK label. For patients who received the gedatolisib triplet and gedatolisib doublet, 5.2% and 3.8% of patients discontinued gedatolisib due to an adverse event, respectively. For patients who received alpelisib, 19.1% discontinued treatment with alpelisib due to an adverse event. Celcuity intends to submit these data to the FDA in the third quarter as an sNDA and to submit VIKTORIA-1 data to other regulatory authorities outside the U.S. following the sNDA submission. Analyses of the mean number of gedatolisib treatment cycles patients received in the PIK3CA WT and MT cohorts of the VIKTORIA-1 Phase 3 trial were also updated as of August 2, 2026, with a median follow-up period of approximately 21 months and 17 months for the PIK3CA WT and MT cohorts, respectively. For patients who received the gedatolisib-triplet, the mean number of treatment cycles on gedatolisib was 9.0 and 10.0 cycles in the PIK3CA WT and MT cohorts, respectively, with 12% (16) and 22% (34) of patients still receiving gedatolisib therapy in each cohort, respectively. For patients who received the gedatolisib-doublet, the mean number of treatment cycles on gedatolisib was 9.7 and 11.3 cycles in the PIK3CA WT and MT cohorts, respectively, with 12% (15) and 19% (10) of patients still receiving gedatolisib therapy in each cohort, respectively. Celcuity expects to provide further updates to results from both the PIK3CA MT and WT cohorts of VIKTORIA-1 at medical conferences in the fourth quarter. 1st Line Setting Celcuity continues to advance gedatolisib combined with palbociclib and endocrine therapy in the first-line setting for patients with HR+/HER2- ABC through its ongoing Phase 3 VIKTORIA-2 clinical trial. The VIKTORIA-2 trial was expanded in the second quarter 2026 to include a second study (Study 2) evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in patients with treatment-naive endocrine-sensitive HR+/HER2- ABC. Study 1 of the VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and fulvestrant in patients with treatment-naive endocrine-resistant HR+/HER2- ABC. Metastatic Castration-Resistant Prostate Cancer (“mCRPC”) Development of gedatolisib in combination with darolutamide continues to advance. In the dose finding portion of Celcuity’s Phase 1b study, evaluation of a 240 mg dose of gedatolisib was completed. No adverse events led to treatment discontinuation of gedatolisib and dose limiting toxicity criteria for dose reduction were not met. Evaluation of a 300 mg dose is ongoing. Once the Phase 1/1b portion of the study is completed, Celcuity expects to select the recommended phase 2 dose level(s) and control arm options for the randomized Phase 2 portion of the study. The company expects to provide updated clinical data and additional visibility into its mCRPC development strategy during the fourth quarter of 2026. Other Recent Developments In June 2026, the Company conducted a public offering of 0.250% convertible senior notes due 2032. The net proceeds from the offering were $557.2 million, after deducting underwriting discounts and commissions and the Company’s estimated offering expenses. The Company utilized $137.0 million of the net proceeds to prepay term loan debt. Celcuity’s advancement of a subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years. Second Quarter 2026 Financial Results Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2026, compared to the second quarter ended June 30, 2025. Net loss for the second quarter of 2026 was $78.9 million, or $1.44 per share, compared to a net loss of $45.3 million, or $1.04 per share, for the prior year period. Non-GAAP adjusted net loss for the second quarter of 2026 was $58.7 million, or $1.07 per share, compared to non-GAAP adjusted net loss of $40.5 million, or $0.93 per share, for the prior year period. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, non-cash investment (income) expense and loss on debt extinguishment. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (“GAAP”) to non-GAAP financial measures, please see the financial tables at the end of this press release. Total operating expenses were $66.1 million for the second quarter of 2026, compared to $44.0 million for the prior year period. Research and development (“R&D”) expenses were $31.1 million for the second quarter of 2026, compared to $36.4 million for the prior year period. The $5.3 million decrease in R&D expenses was primarily due to a $7.0 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial, and a $5.0 million decrease in license milestone costs. These decreases were partially offset by a $3.8 million increase in employee-related and consulting expenses, of which $0.9 million related to stock-based compensation, and a $2.9 million increase in manufacturing and other costs. Selling, general and administrative (“SG&A”) expenses were $35.0 million for the second quarter of 2026, compared to $7.6 million for the prior year period. The $27.4 million increase in SG&A expenses was primarily due to a $14.5 million increase in employee-related expenses, of which $3.3 million related to stock-based compensation. The increase in employee-related expenses was primarily driven by the hiring of additional personnel within our commercial function to support the anticipated launch of REVTORPYK. The remaining $12.9 million increase was primarily due to a $10.8 million increase in costs to support pre-commercial launch activities, including consulting expenses, professional fees and expanding infrastructure costs, and a $2.1 million increase in other administrative expenses. In the aggregate, $23.4 million of the $27.4 million SG&A increase related to commercial headcount additions and other launch-related activities. Net cash used in operating activities for the second quarter of 2026 was $55.4 million, compared to $36.2 million for the prior year period. Cash, cash equivalents and short-term investments were $754.0 million at the end of the second quarter of 2026. We expect that our current cash, cash equivalents and short-term investments will finance our operations at least into 2029. 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: https://viavid.webcasts.com/starthere.jsp?ei=1767665&tp_key=7e57f2ab18. A replay of the webcast will be available on the Celcuity website following the live event. About REVTORPYK (gedatolisib) REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Please click here for Important Safety Information and Full Prescribing Information for REVTORPYK. About Celcuity We are a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. Our first FDA-approved product is REVTORPYKTM (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the 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. Our Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC. Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. 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. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity and its products, including important safety information and full prescribing information can be found at www.celcuity.com. Follow us on LinkedIn and X. Forward Looking Statements This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to REVTORPYK and the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status and timing of the submission, and the FDA’s review, of the Company’s sNDA for gedatolisib, and for making comparable filings with other regulatory authorities outside the U.S.; the market opportunity for gedatolisib; the Company’s expectations regarding the timing of and its ability to commercialize REVTORPYK; the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including subcutaneous formulations to support potential future indications for gedatolisib regimens; the Company’s anticipated use of cash; and the strength of its balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company’s clinical trials or the submission, and FDA’s review of, its sNDA for gedatolisib; the Company’s ability to obtain regulatory approval of its sNDA and maintain regulatory approvals to commercialize REVTORPYK in the U.S. and obtain regulatory approval of gedatolisib outside the U.S., and the market acceptance of REVTORPYK; the development of therapies and tools competitive with gedatolisib; and the Company’s ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. References:1. Internal estimates using data from National Cancer Institute, SEER, 2024; Pan, H, NEJM, 2017;377:1836-46; Dowsett, M 2009; Salvo, E. M. et al. 2021 © 2026 Celcuity Inc. All rights reserved. REVTORPYK and the Celcuity logo are trademarks of Celcuity Inc. Contacts: Celcuity Inc. Brian Sullivan, [email protected] Hahne, [email protected]   (763) 392-0123  Jodi Sievers, [email protected](415) 494-9924 Cautionary Statement Regarding Non-GAAP Financial Measures This press release contains references to non-GAAP adjusted net loss and non-GAAP adjusted net loss per share. Management believes these non-GAAP financial measures are useful supplemental measures for planning, monitoring, and evaluating operational performance as they exclude stock-based compensation expense, non-cash interest expense, non-cash investment (income) expense and loss on debt extinguishment from net loss and net loss per share. Management excludes these items because they do not impact Celcuity’s cash position, which management believes better enables Celcuity to focus on cash used in operations. However, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share are not recognized measures under GAAP and do not have a standardized meaning prescribed by GAAP. As a result, management’s method of calculating non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may differ materially from the method used by other companies. Therefore, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may not be comparable to similarly titled measures presented by other companies. Investors are cautioned that non-GAAP adjusted net loss and non-GAAP adjusted net loss per share should not be construed as alternatives to net loss, net loss per share or other statements of operations data (which are determined in accordance with GAAP) as an indicator of Celcuity’s performance or as a measure of liquidity and cash flows.

Interested in Celcuity, Inc.? Here are five stocks we like better. REVTORPYK launch remains on track: Celcuity expects commercial shipments of its FDA-approved gedatolisib therapy for certain advanced breast cancer patients to begin in late Q3 2026. The treatment has a $30,000 per-cycle wholesale acquisition cost, and the company estimates a U.S. addressable market exceeding $6 billion annually. Clinical expansion continues: Celcuity plans a supplemental filing for the PIK3CA-mutant VIKTORIA-1 cohort after results showed roughly 11 months of median progression-free survival and fewer treatment discontinuations than alpelisib. The company is also expanding first-line breast cancer studies and advancing a prostate cancer trial. Higher losses reflect launch preparations: Q2 net loss widened to $78.9 million as selling, general and administrative expenses increased substantially for commercial hiring and pre-launch activities. Celcuity ended June with $754 million in cash and investments, expected to fund operations into at least 2029. 3 Stocks You’ll Wish You Bought Before 2026 Celcuity (NASDAQ:CELC) said it remains on track to begin commercial shipments of REVTORPYK, its gedatolisib therapy for certain patients with advanced breast cancer, late in the third quarter of 2026 following its recent FDA approval. The FDA approved REVTORPYK in July in combination with fulvestrant, with or without palbociclib, for patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation who progressed on or after at least one line of endocrine therapy in the metastatic setting. Shortly afterward, the National Comprehensive Cancer Network recommended both the triplet and doublet regimens as preferred Category 1 options for second-line or subsequent treatment in tumors without a PIK3CA mutation, Chief Executive Officer and Co-founder Brian Sullivan said during the company’s second-quarter call. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Sullivan said Celcuity plans to submit a supplemental new drug application in the third quarter seeking to include data from the PIK3CA-mutant cohort of its Phase III VIKTORIA-1 trial. The company also expects to submit VIKTORIA-1 data from both the wild-type and mutant cohorts to global regulators after the U.S. filing. At the ASCO annual meeting in June, Celcuity presented results from the PIK3CA-mutant cohort. In the primary analysis, the gedatolisib triplet produced median progression-free survival of 11.1 months, compared with 5.6 months for alpelisib plus fulvestrant, with a hazard ratio of 0.50. The gedatolisib doublet showed median progression-free survival of 11.3 months, compared with 5.6 months for alpelisib plus fulvestrant, with a hazard ratio of 0.51. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Celcuity updated its adverse-event discontinuation analysis using the methodology used for the wild-type cohort in the REVTORPYK label. The company said 5.2% of patients receiving the gedatolisib triplet and 3.8% receiving the doublet discontinued gedatolisib because of an adverse event in the mutant cohort, compared with 19% who discontinued alpelisib due to an adverse event. The company is also expanding its VIKTORIA-2 first-line breast cancer program. A second study will evaluate gedatolisib with palbociclib and letrozole in treatment-naive, endocrine-sensitive HR-positive, HER2-negative advanced breast cancer. The ongoing first study is evaluating gedatolisib, palbociclib and fulvestrant in treatment-naive endocrine-resistant disease. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Sullivan cited an earlier Phase Ib trial of gedatolisib, palbociclib and letrozole in 41 endocrine-sensitive patients, in which median progression-free survival was 48.6 months and the objective response rate was 79%. He said Celcuity is also continuing work on a subcutaneous formulation intended to demonstrate clinical equivalence with the current intravenous formulation. Celcuity said its commercial infrastructure is in place, including 88 oncology sales specialists. The company has engaged key opinion leaders, community breast cancer experts, accounts, oncology organizations and patient advocacy groups as part of its launch preparation, Sullivan said. REVTORPYK will carry a wholesale acquisition cost of $10,000 per vial, or $30,000 per treatment cycle. Celcuity estimated a combined wild-type and mutant second-line U.S. addressable market of more than $6 billion annually, based on an estimated 37,000 patients receiving second-line treatment and approximately 10 treatment cycles per patient. The company opened an expanded-access program before commercial availability and said it has already begun shipping drug to participating sites. Patients in the program are expected to transition to commercial supply after launch, with the timing dependent on patient and site circumstances to avoid interruptions in treatment. During the question-and-answer session, Sullivan said Celcuity submitted validation information for a second manufacturing site shortly after FDA approval. The company cannot ship product from that site until it receives FDA clearance, but Sullivan said management remains confident in its ability to begin shipments late in the third quarter. He noted that the review process can take about two to four months, depending on the FDA’s review and any issues that arise. Celcuity is also advancing a Phase Ib/II trial of gedatolisib with darolutamide in metastatic castration-resistant prostate cancer. The company completed evaluation of a 240-milligram gedatolisib dose in the dose-finding portion of the study, with no adverse events leading to gedatolisib discontinuation and no dose-limiting toxicity criteria for dose reduction met. Evaluation of a 300-milligram dose is underway. Celcuity expects to provide additional clinical data and discuss its prostate cancer development strategy during the fourth quarter. Sullivan said possible updates could include PSA50 response data, progression-free survival data and subgroup analyses, though data from the 300-milligram dose may not yet be mature. Celcuity reported a second-quarter net loss of $78.9 million, or $1.44 per share, compared with a net loss of $45.3 million, or $1.04 per share, in the prior-year period. Non-GAAP adjusted net loss was $58.7 million, or $1.07 per share, compared with $40.5 million, or $0.93 per share, a year earlier. Research and development expense declined to $31.1 million from $36.4 million, primarily reflecting lower VIKTORIA-1 clinical trial costs. Selling, general and administrative expense rose to $35 million from $7.6 million, driven largely by commercial hiring and pre-launch activities for REVTORPYK. Cash used in operating activities was $55.4 million, compared with $36.2 million in the prior-year quarter. Cash, cash equivalents and short-term investments totaled $754 million as of June 30, up from $441.5 million at year-end 2025. Chief Financial Officer Vicky Hahne said the increase in cash was primarily driven by a June convertible note offering that generated $557.2 million in net proceeds. The company used a portion of the proceeds to repay $137 million of term-loan debt. Celcuity said it expects its cash, cash equivalents and investments to fund operations at least into 2029. Celcuity, Inc is a clinical-stage biotechnology company specializing in precision oncology diagnostics. The company develops and commercializes predictive biomarker assays designed to identify which patients are most likely to benefit from targeted cancer therapies. By integrating functional profiling of tumor cells with molecular analyses, Celcuity seeks to optimize treatment selection and improve outcomes for patients with solid tumors. Celcuity’s proprietary platform evaluates tumor cell sensitivity to various therapeutic agents using ex vivo assays that measure DNA damage response and other critical pathways. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Celcuity Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

MINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that it will release its financial results for the second quarter 2026 after the market closes on Thursday, August 13, 2026. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Daylight 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: https://viavid.webcasts.com/starthere.jsp?ei=1767665&tp_key=7e57f2ab18. A replay of the webcast will be available on the Celcuity website following the live event. About Celcuity Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK™ (gedatolisib), a pan-PI3K and mTORC1/2 inhibitor that comprehensively blocks 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- locally advanced or metastatic breast cancer (“ABC”), supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected. Results for the PIK3CA mutant cohort of VIKTORIA-1 were presented during an oral presentation at the American Society for Clinical Oncology (ASCO) in June 2026. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine- sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis, Minnesota. Further information about Celcuity and its products, including important safety information and full prescribing information can be found at www.celcuity.com. Follow us on LinkedIn and X. Contacts: Celcuity Inc. Brian Sullivan, [email protected] Hahne, [email protected]   (763) 392-0123  Jodi Sievers, [email protected](415) 494-9924

The data show that the drug, in combination with others, reduced the risk of disease progression or death by about 50%. Celcuity said the results mark the first time a Phase 3 trial has shown one drug of this class clearly outperforming another in the specific patient group. The company plans to file a supplemental application to the FDA later this year based on the new data. Shares of Celcuity Inc. (CELC) tumbled 26% on Tuesday after the company reported patient deaths in a late-stage trial of its experimental drug, gedatolisib, in advanced breast cancer, despite it reducing disease progression overall. The Minneapolis-based biotechnology company announced detailed results from a major late-stage study of its experimental drug gedatolisib in patients with a common form of advanced breast cancer. The trial tested two combinations of gedatolisib — one with the hormone blocker fulvestrant and the targeted drug palbociclib (the “triplet”), and one with just fulvestrant (the “doublet”) — against the current standard of alpelisib plus fulvestrant. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox One patient receiving the gedatolisib triplet died from a treatment-related side effect, the company said, while adding that investigators linked it to the palbociclib component. By comparison, two patients on the standard alpelisib-plus-fulvestrant regimen experienced treatment-related fatal side effects. No treatment-related deaths occurred among patients on the gedatolisib doublet, it added. In patients whose tumors had a specific PIK3CA mutation, both gedatolisib regimens roughly doubled the time patients lived without their cancer worsening. Median progression-free survival reached 11.1 months with the triplet and 11.3 months with the doublet, compared with 5.6 months for alpelisib plus fulvestrant. That translated to a 50% lower risk of disease progression or death for the triplet and a 49% lower risk for the doublet. Tumors shrank in 48.9% of patients on the triplet and 35.7% on the doublet, versus 26% on the standard treatment. Responses also lasted longer with gedatolisib: a median of 15.7 months for the triplet and 24.2 months for the doublet, compared with 7.5 months for alpelisib plus fulvestrant. Overall survival data from the trial remain immature—meaning follow-up is too short for final conclusions—but early trends favored both gedatolisib regimens over the current standard treatment, the company said. The safety profile was generally consistent with earlier data, the company said. The most common serious side effects in the gedatolisib triplet were a drop in infection-fighting white blood cells (neutropenia) and mouth sores. Overall, few patients stopped treatment because of side effects — about 2.6% in the triplet group and 3.8% in the doublet group, versus 7.1% in the alpelisib group. Celcuity said the results mark the first time a Phase 3 trial has shown one drug of this class clearly outperforming another in this patient group. The company is also developing gedatolisib for patients without the PIK3CA mutation and has already filed for U.S. approval in that larger group for which a decision is expected in July. The company also plans to file a supplemental application to the FDA later this year based on the new data. On Stocktwits, retail sentiment around CELC stock rose from ‘neutral’ to ‘extremely bullish’ territory over the past 24 hours, while message volume jumped from ‘low’ to ‘high’ levels. A Stocktwits user termed the data readout as “great,” while terming the stock reaction as “super inordinate.” Another user highlighted several upsides, including the upcoming FDA decision on the drug in patients with certain forms of breast cancer. CELC stock has gained about 687% over the past 12 months. Read More: SWMR Stock Surges 46% After Jim Cramer Calls It a 'Natural' Drone Bet For updates and corrections, email newsroom[at]stocktwits[dot]com. Anan Ashraf has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: SWMR Stock Surges 46% After Jim Cramer Calls It a 'Natural' Drone Bet ABVX Stock Clocks Worst Day Ever On Malignancy Signal For Drug: ‘Pharma Bro’ Says ‘GLPs Are Doing Fine’ After Similar Fears VKTX Eyes Worst Week Since November As Trial Data Looms — Wall Street Still Sees 200% Upside

MINNEAPOLIS, June 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced it will host a conference call and live webcast to review results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial on Tuesday, June 2, 2026 at 8:00 a.m. EDT / 7:00 a.m. CDT. Webcast and Conference Call Information The Celcuity management team will host a live webcast and conference call on Tuesday, June 2, 2026, at 8:00 a.m. EDT / 7:00 a.m. CDT to discuss the results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. A replay of the webcast will be available on the Celcuity website. About Celcuity Celcuity is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. Our lead therapeutic candidate is gedatolisib, a kinase inhibitor of the PI3K/AKT/mTOR (“PAM”) pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the 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. Our Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) (“HR+/HER2-”) locally advanced or metastatic breast cancer (“ABC”), has reported detailed results for Study 1, which evaluated patients with PIK3CA wild-type (“WT”) tumors, and announced topline results for Study 2, which evaluated patients with PIK3CA mutant-type (“MT”) tumors. Our Phase 3 clinical trial, VIKTORIA-2, is ongoing and incorporates two independent studies, Study 1 and Study 2, evaluating two separate cohorts of patients with advanced breast cancer who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib combined with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib combined with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. 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. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis, Minnesota. Further information about the Company can be found at www.celcuity.com. Follow us on LinkedIn and X. Contacts: Celcuity Inc. Brian Sullivan, [email protected] Hahne, [email protected]   (763) 392-0123  Jodi Sievers, [email protected](415) 494-9924

Image source: The Motley Fool. Thursday, May 14, 2026 at 4:30 p.m. ET Chief Executive Officer and Co-Founder — Brian F. Sullivan Chief Financial Officer — Vicky Hahne Chief Medical Officer — Igor Gorbachevsky Chief Commercial Officer — Eldon C. Mayer Vice President of Investor Relations — Jodi Sievers Need a quote from a Motley Fool analyst? Email [email protected] Jodi Sievers: Thank you, Matthew, and good afternoon, everyone. Thank you for joining us to review Celcuity's first quarter 26 financial results and business update. Earlier today, Celcuity released for the first quarter ended 03/31/2026. The press release can be found on the Investors section of Celcuity's website. Joining me on the call today are Brian F. Sullivan, Celcuity's chief executive officer and co-founder; Vicky Hahne, chief financial officer; as well as Igor Gorbachevsky, chief medical officer; and Eldon C. Mayer, chief commercial officer, who will also be available during Q&A. Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward-looking statements. Such forward-looking statements and their implications involve known and unknown risks. Uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. On this call, we will also refer to non GAAP financial measures. These non GAAP measures are used by management to make strategic decisions forecast future results, and evaluate the company's current performance. Management believes the presentation of these non GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing operations and prospects for the future. You can find the table reconciling the non GAAP financial measures to GAAP measures in today's press release. And with that, I will turn the call over to Brian F. Sullivan, CEO of Celcuity. Please go ahead, Brian. Brian F. Sullivan: Thank you, Jodi, and good afternoon, everyone. Thank you for joining our first quarter 26 operating and financial update conference call. We continue to make great progress as we prepare for the potential approval and commercial launch of gedatolisib in the third quarter. Achieving these milestones would be a pivotal moment for the women with advanced breast cancer who need new therapeutic options. With the groundbreaking data we have previously reported from the wild type cohort, the recent announcement of positive data from the mutant cohort of our VICTORIA-1 study, we believe gedatolisib is well positioned to become a new standard-of-care second-line therapy. For patients with HR-positive, HER2-negative advanced breast cancer. it is been an eventful past few months for Celcuity. Last week, we reported positive top line results for the PIK3CA mutant cohort of the Phase III VICTORIA-1 clinical trial, and we look forward to presenting detailed results at a late breaking abstract oral session at the 26 ASCO meeting on June 2. Given the timing of our ASCO presentation, we will not be answering questions regarding these results during the Q&A portion of our call. Second, this morning, we announced 2 important updates to our clinical development plan. First, we announced the expansion of our Phase III VICTORIA-2 trial to include a second study evaluating gedatolisib as first line treatment in patients with endocrine sensitive HR-positive/HER2-negative advanced breast cancer. We are now positioned to evaluate nearly all patients in the first line setting, irrespective of their endocrine sensitivity or PIK3CA status. And this offers the potential to advance the standard of care for the approximately 90 thousand women each year who are newly diagnosed in the US with HR-positive, HER2-negative advanced breast cancer. And secondly, we also announced this morning that we are advancing the development of a gedatolisib formulation for subcutaneous injection, and that we have submitted our first patent application to the US Patent and Trademark Office. Subcutaneous formulation is aimed at supporting potential future for gedatolisib regimens that may result in duration of treatment periods greater than several years. And finally, we remain optimistic about the outcome of the FDA's review of our NDA. Assuming our NDA is approved, we intend to submit to the FDA a supplemental new drug application based on the results of the PIK3CA mutant cohort of VICTORIA-1 and to submit VICTORIA-1 data for both the mutant and wild type cohorts to other global regulatory authorities following the sNDA submission. Turning now to the top line results for the PIK3CA mutant cohort. The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib which we refer to as the gedatolisib triplet, demonstrated a statistically significant and clinically meaningful improvement in progression free survival compared to alpelisib, which is a PI3K alpha inhibitor, fulvestrant. The secondary endpoint of gadatolitinib combined with fulvestrant, which we refer to as the gedatolisib doublet, which was not part of the primary efficacy analysis in the hierarchical order. Demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated with manageable safety profiles, and no new safety signals. When considered alongside previously presented data from the VICTORIA-1, PIK3CA wild type cohort, the gedatolisib regimens have now demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIK3CA status of a patient's tumor. And we believe the results from the VICTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K/AKT/mTOR, or PAM, pathway. Researchers have sought for nearly 20 years to develop a drug that blockades this pathway comprehensively without inducing unacceptable levels of toxicity. VICTORIA-1 represents the first phase 3 study that demonstrated that comprehensively blocking the pan pathway can significantly improve outcomes for patients with PIK3CA mutations compared to therapies only targeting a single component. of this pathway. Now as we have previously reported, the VICTORIA-1 PIK3CA wild-type cohort set several new benchmarks for clinical trials evaluating patients with HR-positive, HER2-negative advanced breast cancer. The hazard ratios for the gedatolisib triplet and doublet were more favorable than has ever been reported by any phase III trial for patients with HR-positive/HER2-negative advanced breast cancer. 7.3 months incremental improvement in median PFS for the gedatolisib triplet over fulvestrant is higher than has ever been reported by any phase 3 trial for patients with HR-positive/HER2-negative advanced breast cancer receiving at least their second line of endocrine therapy. And the 17.5 months of median duration of response for the gedatolisib triplet and 31% incremental increase in the objective response rate relative to the control for the gedatolisib triplet are the highest reported for an endocrine therapy based regimen in the second line setting. Both regimens were found to have a manageable safety profile and was well tolerated by patients, as evidenced by the 2% and 3% adverse event related discontinuation rates for the triplet and doublet, respectively. We have also previously reported safety and tolerability related analyses. In particular, for patients who experience stomatitis, we reported that measures to mitigate it were generally effective, The median time to improvement from first onset to a lower grade of stomatitis for patients with grade 2 or grade 3 stomatitis who receive the gedatolisib triplet. Was 12 and 14 days, respectively. Now to characterize the overall tolerability of the gedatolisib regimens, we reported results from patient reported outcomes, the capture of patients' perception of their overall well-being. Of particular note, was the stability of the patient's assessment of their well-being relative to their well-being prior to starting treatment with gedatolisib. Over the first 8 cycles of treatment with gedatolitinib, patients reported no degradation in their sense of well-being, which we believe provides meaningful evidence that patients treated with gedatolisib tolerated well. Now let's talk about our VICTORIA-2 study. Results from the PIK3CA wild type mutation cohort of our VICTORIA-1 study demonstrated the benefit of gedatolisib combination treatment in the second line setting of HR-positive/HER2-negative advanced breast cancer. These results confirm the role the PAM pathway plays in patients with or without PIK3CA mutations and the importance of multi target inhibition of this pathway. Additionally, results from our Phase Ib clinical trial provided strong evidence that the PAM pathway is also an important disease driver in treatment naive patients with advanced breast cancer. In the early phase study that we performed, we evaluated gedatolisib plus letrozole as first line treatment in patients with endocrine sensitive HR-positive/HER2-negative advanced breast cancer. Median progression free survival, or PFS, was 48.6 months, This compares favorably to historical data of approximately 25 months for ribociclib plus letrozole, And the objective response rate was 79%. Which, again, compares favorably to historical data of 53% for ribociclib plus letrozole. In light of the positive results for the PIK3CA wild type and mutant cohorts of VICTORIA-1, and the promising preliminary data for our gedatolisib triplet in this first line treatment, we have high confidence that we can successfully develop a gedatolisib triplet for nearly all patients in the first line setting irrespective of their endocrine sensitivity or PIK3CA status. Successful development in the first line setting would offer the potential to advance the standard of care for the approximately 90 thousand women each year who are diagnosed with late stage HR-positive/HER2-negative advanced breast cancer in the United States. So to achieve this goal, we amended several important elements of the VICTORIA-2 study design. First, VICTORIA-2 will now evaluate the safety and efficacy of patients with endocrine sensitive HR-positive/HER2-negative advanced breast cancer. in addition to those with endocrine resistant disease. Which was the original study. Endocrine sensitive patients represented approximately 2/3, or 60 thousand of the 90 thousand women in the US newly diagnosed with advanced breast cancer each year. Current standard of care therapies for these patients provide a median PFS of approximately 25 months. Patients will be assigned manually according to their endocrine sensitivity status to either study 1 if they are endocrine resistant or study 2 if they are endocrine sensitive. And subsequently be randomized to a treatment arm. Each study will have independent statistical analysis plans that will include separate primary endpoints. Second, the primary efficacy analyses for both study 1 and study 2 of VICTORIA-2 will evaluate the entire intent to treat population enrolled in their respective study. Primary endpoints for patient cohorts based on their PIK3CA status are no longer included. And this revision of the primary analyses allowed us to reduce the sample size for Study 1, endocrine resistant study, from 38 patients to 44 patients without affecting the power of the analysis. And third, the control arms for study 1 and study 2 will evaluate ribociclib combined with either fulvestrant for study 1 or letrozole for study 2. Study 1 will enroll patients with treatment naive endocrine resistant advanced breast cancer. And these are women whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. it is a more aggressive disease. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and fulvestrant in arm A, and compare that to ribociclib combined with fulvestrant in arm B. We expect to have top line data by 2028 for this study. Study 2 is expected to enroll approximately 740 subjects with treatment naive, endocrine sensitive advanced breast cancer. And these are women whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease who have had no prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole, and compare that to ribociclib combined with letrozole. The clinical trial primary endpoints for the VICTORIA-2 clinical trial is progression-free survival per RECIST 1.1 criteria. As assessed by blinded independent central review. And we expect top line data for the study 2 in the endocrine-sensitive patients. To be available by 2030. And prior to finalizing this amended phase 3 trial design, we conducted a Type B meeting with the FDA to obtain their feedback and to gain alignment on these planned amendments. Now knowing that our life cycle plan would eventually include indications that may offer several years of progression free survival benefit, We initiated a program to develop a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection as an alternative to an infusion. And this program is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation. And this work has resulted in a submission to the United States Patent and Trademark Office of our first patent application for an injectable formulation of gedatolisib. Now let's turn to our ON-TRACC 1b/2 trial, that is evaluating gedatolisib in combination with darolutamide. Men with metastatic castration resistant prostate cancer. We presented data for the Phase Ib portion of the study at a poster presentation at ESMO last year. In this portion of the trial, 38 patients were randomly assigned to receive standard doses of darolutamide twice daily, and other 120 milligrams of gedatolisib in arm 1 or 180 milligrams of gedatolisib in arm 2. The combination of gedatolisib and darolutamide was generally well tolerated in the trial, and mostly low grade treatment related adverse events. No dose limiting toxicities were observed in either arm, No patients discontinued study treatment due to an adverse event. For all patients treated, the 6-month radiographic PFS rate was 67%, and the median radiographic PFS was 9.1 months. And these results compare favorably to historical results of a 40% 6-month radiographic PFS rate for patients with metastatic castration resistant prostate cancer who were treated with an androgen receptor inhibitor as second line treatment. Now enrollment of patients in the dose escalation portion of the trial is ongoing. We expect to provide a data update at an upcoming medical conference. Now as we near what we hope is an FDA approval, for gedatolisib in 2026, our efforts to prepare for the potential launch of gedatolisib continue to ramp up per our strategic launch plan. And we began laying the groundwork for a potential gedatolisib launch over 24 months ago. Last call, we mentioned that we had largely completed building the commercial organization. except for the sales force. I am excited to report now that we have since hired and onboarded all of our oncology sales specialists. They are a very experienced crew. On average, these individuals have 24 years of experience selling pharmaceuticals, and 16 years of experience in oncology. They are an incredibly talented group of individuals who have a strong track record of successfully launching novel oncology therapeutics. And key efforts to date include continuing our extensive outreach across the country to payers, strategic accounts which include health systems, integrated delivery networks, and community oncology practices. We are also very encouraged by the results of research we have continued to field to gauge the willingness of community and academic oncologists to prescribe gedatolisib should it get approved. And these results make us optimistic about the possibility of establishing gedatolisib as the new standard of care in the second line setting for HR-positive/HER2-negative advanced breast cancer. In the wild-type patient population. Now with positive results from our study with patients whose tumor have PIK3CA mutations we expect the gedatolisib combination regimens to be uniquely positioned to provide second line therapy for patients regardless of their PIK3CA mutation status. Based on the analysis of published epidemiological data, we estimate there are 37 thousand patients in the US receiving second line treatment for HR-positive/HER2-negative advanced breast cancer, and using internal duration of treatment estimates and pricing assumptions consistent with currently available novel therapeutics for breast cancer, we estimate the total addressable market for gedatolisib in the second line setting is more than $5 billion annually. Given the significant penetration our research is suggesting we can achieve, we believe it is reasonable to estimate. That a second line indication for gedatolisib can potentially generate peak revenue of up to $2.5 billion annually. The progress we have made today is encouraging, and we look forward to providing you with updates over the next few quarters. Gedatolisib is well positioned to address critical needs in the second line space with its unique mechanism of action and potential first in class and best in class safety and efficacy profile. And this gives us an exciting opportunity to advance potential blockbuster indications in breast cancer and prostate cancer while also aggressively preparing for and potentially launching gedatolisib commercially. Should we receive FDA approval. Now I would like to hand the call over to Vicky to review our finances. Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I will provide a brief overview of our financial results for the first quarter 26. Our first quarter net loss was $52.8 million or $0.97 per share compared to a net loss of $37 million or $0.86 per share for 2025. Our non GAAP adjusted net loss was $46.8 million or $0.86 per share for the 2026 compared to non GAAP adjusted net loss of $34.7 million or $0.81 per share for 2025. Research and development expenses were $33.1 million for the 2026 compared to $29.8 million for the prior year period. The $3.3 million increase was primarily due to a $3 million increase in employee related and consulting expenses. The remaining increase was primarily due to a $5.4 million increase in manufacturing and other costs partially offset by a $5.1 million decrease in clinical trial costs which was primarily driven by decreased costs for the VICTORIA-1 phase 3 clinical trial. Selling, general, and administrative expenses were $17.4 million for the 2026, compared to $6.3 million for the prior year period. The $11.1 million increase was primarily due to an $8.7 million increase in employee related and consulting expenses of which $6.6 million was due to commercial headcount additions and other launch related activities. The remaining $2.4 million increase was primarily due to software costs professional fees, and other administrative costs. Net cash used in operating activities for the 2026 was $55.1 million compared to $35.9 million for the prior year period. The additional cash in operating activities quarter over quarter of $19.2 million was primarily due to non GAAP adjusted net loss of $12.1 million and working capital adjustments of $7.1 million Cash, cash equivalents, and short-term investments totaled $290.4 million as of the end of the first quarter of 2026. We expect cash, cash equivalents and investments, and drawdowns on our debt facility to finance our operations through 2027. I will now hand the call back to Jodi. Jodi Sievers: Thanks, Vicky. Before we turn the call to the operator for questions, I will remind you that we will not be answering questions related to the VICTORIA-1 mutant cohort data being presented at ASCO on June 2 or providing additional guidance on our expectations for data at this time. Operator: Matthew, could you please open the call for questions?. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the #1 on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press * followed by the #2. If you are using a speakerphone, please remove your handset before pressing any keys. 1 moment, please, for your first question. And your first question comes from Maury Raycroft of Jefferies. Analyst (Maury Raycroft): Your line is open. 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This article first appeared on GuruFocus. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Celcuity Inc (NASDAQ:CELC) reported positive top-line results for the PIK3CA mutant cohort of the Phase III Victoria I clinical trial, indicating a significant improvement in progression-free survival. The company is preparing for the potential approval and commercial launch of Gedit-Silisib in the third quarter, which could become a new standard-of-care for HR-positive HER2-negative advanced breast cancer. Celcuity Inc (NASDAQ:CELC) announced the expansion of their Phase III Victoria II trial to include a study evaluating gadotilisib as a first-line treatment, potentially advancing the standard of care for newly diagnosed patients. The company is developing a subcutaneous formulation of gadotilisib, which could support future indications and improve patient convenience. Celcuity Inc (NASDAQ:CELC) has completed building their commercial organization and hired experienced oncology sales specialists in preparation for the potential launch of gadotilisib. Celcuity Inc (NASDAQ:CELC) reported a net loss of $52.8 million for the first quarter of 2026, an increase from the previous year's loss of $37 million. Research and development expenses increased to $33.1 million, driven by higher employee-related and consulting expenses. Selling, general, and administrative expenses rose significantly to $17.4 million, primarily due to commercial headcount additions and launch-related activities. The company used $55.1 million in net cash for operating activities in the first quarter, up from $35.9 million in the prior year period. There is uncertainty regarding the FDA's review timeline and potential approval of the NDA for gadotilisib, which could impact the company's strategic plans. Warning! GuruFocus has detected 3 Warning Sign with CELC. Is CELC fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide any perspective on the nature of questions and interactions with the FDA ahead of the PDUFA date? Have you submitted a draft label, and are you in labeling discussions? A: We are not providing detailed information about our interactions with the FDA, but there is nothing to suggest that we are off track for the PDUFA decision by July 17th. - Brian Sullivan, CEO Q: Can you provide more details on the subcutaneous (sub-Q) formulation, particularly regarding preclinical data on PK/PD comparability and dosing frequency? A: We are optimizing the formulation and working on manufacturing and stability. We expect to conduct PK studies to confirm the profile and map its equivalence to the IV formulation. The goal is to have the sub-Q form available along the same timeline as the potential approval for the endocrine-sensitive population. - Brian Sullivan, CEO Q: Regarding the sub-Q announcement, is there an analog of a small molecule that was given IV and then changed to subcutaneous? Also, would the PK and CMAX change when going from IV to sub-Q? A: The regulatory process requires characterizing the PK profile and demonstrating clinical equivalence. The FDA's guidance suggests that demonstrating equivalence in one indication allows the new formulation to be used for other indications. We aim to match the PK profile closely, and while it's premature to speculate on the somatitis effect, we believe the concentration stability contributes to the drug's tolerability. - Brian Sullivan, CEO Q: How does the design of the VIC-2 Study 2 factor in the influence of longer-term OS data in the endocrine-sensitive setting? A: OS is used to break ties when regimens offer equivalent PFS. If we offer superior PFS to rival drugs and show no decrement in OS, it would demonstrate clinical benefit. The study is designed to show a meaningful increase in PFS, considering the expectations for clinically meaningful benefits. - Brian Sullivan, CEO Q: What are your updated thoughts on the competitive positioning for GETA versus other PIK3 inhibitors in development, especially with a subcutaneous formulation coming online? A: The GETA doublet has shown statistically significant and clinically meaningful differentiation from single-target inhibitors. Multi-target inhibition is required for optimal anti-tumor control, and single-target inhibitors are limited. We believe our approach offers superior efficacy compared to existing PIK3CA-approved drugs. - Brian Sullivan, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript.