管理層發言
Good afternoon, ladies and gentlemen. Welcome to Celcuity's second quarter 2026 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.
Thank you, Operator, and good afternoon to everyone. Thank you for joining us today to review Celcuity's second quarter 2026 financial results and business update. Earlier today, Celcuity 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 co-founder; 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, and evaluate the company's current performance. Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to the GAAP measures in today's press release. With that, I would like to turn the call over to Brian F. Sullivan, CEO of Celcuity.
Please go ahead, Brian.
Thank you, Jodi, and good afternoon, everyone. Thank you for joining our second quarter 2026 operating and financial update conference call. Celcuity continues to make monumental progress advancing clinical development of gedatolisib for patients with HR-positive, HER2-negative advanced breast cancer. With the FDA approval of Revtopik, positive results from the PIK3CA-mutant cohort of our pivotal VICTORIA-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 with HR-positive, HER2-negative advanced breast cancer. We remain on track to begin shipping Revtopik late in the third quarter of 2026, and 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 2026. 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 fulvestrant, 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 one line of endocrine therapy in the metastatic setting. A little over two 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. The primary efficacy analysis of the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to alpelisib, a PI3K-alpha inhibitor, plus fulvestrant. Median PFS was 11.1 months with the gedatolisib triplet versus 5.6 months with alpelisib plus fulvestrant, with a hazard ratio of 0.50. The second 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. Median PFS was 11.3 months with the gedatolisib doublet versus 5.6 months with alpelisib 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. We have since updated 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 the PIK3CA wild-type cohort presented in the alpelisib 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% discontinued treatment with alpelisib due to an adverse event. 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 fell disproportionately on the wild-type cohort. 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 2, 2026. 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, and 34 of these patients, representing 22% 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; 15 of these patients, representing 12% of those dosed, were still receiving gedatolisib. 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; 10 of these patients, representing 19% of those dosed, are still receiving gedatolisib. 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 have on 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. 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. We also expect to submit VICTORIA-1 Phase 3 data for both the wild-type and mutant cohorts to global regulatory authorities following the sNDA submission. 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 (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 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. 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 two-thirds of the women in the U.S. newly diagnosed with advanced breast cancer each year, and current standard-of-care therapies for these patients provide median PFS of approximately 25 months. Study 1 of VICTORIA-2, 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. These are patients whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. Results from the Phase 1b clinical trial 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 that 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, the therapy we are using as the control in our VICTORIA-2 trial for 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 the 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 90,000 women each year who are diagnosed with late-stage HR-positive, HER2-negative advanced breast cancer in the U.S., irrespective of their endocrine sensitivity or PIK3CA status. Our 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 at supporting potential future indications for gedatolisib regimens that may result in treatment durations greater than several years. Turning to our Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant 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. 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 two 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 2026. 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 1,000 key opinion leaders and community breast cancer experts, over 250 key accounts, major oncology organizations including group purchasing organizations, 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 awareness about the unmet need in the second-line setting. The build-out of the commercialization infrastructure needed to support a successful launch of Revtopik is now complete, and commercial launch activities for Revtopik 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 electronic health record systems at their accounts, and are 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 Revtopik 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 provide patients and providers with rapid access and seamless support. Shipments of Revtopik are expected to begin late in the third quarter of 2026. Wholesale Acquisition Cost (WAC) for Revtopik, which has been reported to the drug pricing compendia, will be $10,000 per vial or $30,000 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 37,000 patients in the U.S. receiving second-line treatment for HR-positive, HER2-negative advanced breast cancer. Assuming an average of roughly 10 cycles of treatment for Revtopik per patient at the WAC price, we estimate the total addressable market for Revtopik in the wild-type and mutant settings combined is potentially over $6 billion annually. That concludes my remarks. I would now like to hand the call over to Vicky to review our finances.
Thank you, Brian, and good afternoon, everyone. I will provide a brief overview of our financial results for the second quarter of 2026. 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 2026 compared to a 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 2026 compared to $36.4 million for the prior year period. The $5.3 million decrease was primarily due to a $7.0 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VICTORIA-1 Phase 3 clinical trial. The remaining change was primarily due to a $5.0 million decrease in license milestone costs, partially offset by a $3.8 million increase in employee-related and consulting expense and a $2.9 million increase in manufacturing and other costs. Selling, general, and administrative 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 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 Revtopik. 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 2026 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 our non-GAAP adjusted net loss of $18.2 million and working capital adjustments of $1.0 million. Cash, cash equivalents, and short-term investments were $754.0 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, which 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.
Operator, could you please open the call for questions?
分析師問答
Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. You may press star followed by the number one on your telephone keypad to ask a question. To withdraw your question, please press star followed by the number two. One moment for your first question. Your first question comes from the line of Tara Bancroft with TD Cowen. Please go ahead.
So I guess what I would really like to understand is what underpins your confidence in the late Q3 shipments. For instance, are you initially launching with existing clinical supply? If so, how long would that supply last? And how long is the process for setup with the backup manufacturing site, and what does that entail? I know that sounds like a lot of questions, but I am really trying to understand your level of confidence in supplying the launch without delay.
As I explained a couple of weeks ago, we want to have confidence that our review process with the FDA will proceed as we expect and that there are no surprises. We are very confident about being able to ship beginning at the end of this quarter. Nothing has changed.
Okay. And as part of that review process, do you need an inspection?
The FDA can conduct inspections as they determine appropriate. Typically, if a manufacturer has met requirements, an inspection is not necessarily required. We would not want to project exactly what the FDA will do, but we believe the validation data we have is very consistent with the validation from our first site, and we anticipate the review process will be straightforward.
Okay. Great. Thanks so much.
Your next question comes from the line of Maury Raycroft with Jefferies. Please go ahead.
Hi, congrats on the progress and thanks for taking my questions. I will follow up on Tara's questions. Can you clarify if you submitted the validation work and necessary information to the FDA yet, and what are the rate-limiting steps remaining? Do you need FDA to provide any type of sign-off before you can launch with product from that site?
Two things: we submitted the validation data almost immediately after we got the approval. We provided the package of information required for the FDA to review and approve the use of that manufacturing site. You cannot ship from that new site until you have received the go-ahead from the FDA; that is the limitation on accessing material from that second site. We have visibility on the review process for that site and remain confident in our ability to ship in late third quarter.
Got it. Maybe one other question on the expanded access program: how many sites or doctors are participating, do you have patients enrolled already, and will you provide quarterly updates on enrollment there?
We just got the expanded access program started last week. We submitted to the FDA and obtained central IRB approval, and we have already begun shipping product to investigators who are treating patients. We are not planning to provide quarterly updates on the expanded access program, as the intent is this program will be transitional and will conclude once commercial supply is available, and we expect rapid transition to commercial supply.
And then presumably, once you have commercial drug launched, those patients would convert over to commercial product, correct?
Exactly. That transition is reflected in the protocol.
Your next question comes from the line of Brad Canino with Guggenheim. Please go ahead.
Thanks for the update, especially around the prostate cancer progress. I am actually wondering about endometrial cancer: one of your competitors is doing a lot of work in endometrial cancer. How do you think about that as an opportunity for gedatolisib? I know some earlier data from other companies may not have had the right regimen or setting, so how would you consider bringing that into your development portfolio if it is an opportunity?
There is certainly a strong rationale for us to consider endometrial cancer. Preliminary data generated previously indicated that even as monotherapy, gedatolisib can induce an objective response. The underlying drivers of the disease include the role of the PIK3CA pathway for a significant cohort of endometrioid patients, and the hormonal pathway is also involved. There is a strong rationale to consider development in that setting, and we will update our development plans as we get further into the year.
And in prostate specifically, KOLs are discussing capivasertib and its potential role as a PAM pathway inhibitor. As you talk with investigators and KOLs, what can be learned from capivasertib data that is relevant to gedatolisib, and what differences should we keep in mind?
Capivasertib is approved in breast cancer to treat patients with certain pathway abnormalities. Its efficacy was comparable to alpelisib in a similar setting. Gedatolisib showed roughly double the activity relative to alpelisib in our comparative data, which we think is a reasonable proxy for what capivasertib is capable of doing. Capivasertib's approval in a PTEN-loss population in prostate disease, which is a relevant mutation in the PAM pathway, is encouraging. Their positive results in an earlier-stage, hormone-sensitive prostate population provide an additional demonstration of the pathway's importance. Our hypothesis is that combining gedatolisib with an androgen receptor inhibitor can improve outcomes relative to androgen receptor inhibitor alone; we have encouraging data and will update it later this year.
Your next question comes from the line of Eva Fortea-Verdejo with Wells Fargo. Please go ahead.
Hi team, congrats on the progress and thanks for taking our question. A quick one on the expanded access program: how long do you expect it will take to transition a patient from the EAP to commercial following the launch in late Q3?
I do not want to commit to a specific timeline. We will be very sensitive to patient needs and ensure there is no interruption in supply. Transition timing can be site- and patient-specific, depending on insurance and other factors. The intent is to transition EAP patients to commercial supply; that is embedded within the protocol and well understood by participating investigators. Transition could occur between cycles, for example from day 15 to the next cycle, but the overall goal is to ensure a smooth, disruption-free transition.
And your next question comes from the line of Andrew Berens with Leerink Partners. Please go ahead.
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.
We have done a robust analysis identifying the various components of discounts, which reflect channel differences rather than discounting of the drug itself. For Revtopik, we expect gross-to-net to be about 80% of WAC, implying discounts of around 20%. For oral therapies in this category, gross-to-net discounts can be about 30%, so we expect to capture a higher percentage of WAC compared to corresponding oral therapies.
Your next question comes from the line of Oliver McCammon with LifeSci Capital. Please go ahead.
Maybe just a broader question on commercialization and engaging physicians. What proportion of community oncology practices, including associated infusion centers and geography, do you think would be amenable to IV therapy in this setting? And are there learnings to take from the fairly common use of IV-administered HER2 therapies even in second line?
We believe nearly every community practice has access to infusion centers because many important therapies in breast cancer are infused, including HER2-directed antibodies, checkpoint inhibitors like pembrolizumab in TNBC, and chemotherapies. Treating breast cancer routinely requires infusion access, so we do not expect barriers for community oncologists to prescribe gedatolisib and ensure their patients can receive infusions. Community treaters handle the majority of care in this space.
Ladies and gentlemen, please continue to stand by. Your conference will resume momentarily. Thank you. Ladies and gentlemen, we will now resume our conference. Brian, please go ahead.
Thank you. I hope you all heard the last answer. Operator, if there are additional questions, I am happy to answer them.
Your next question comes from the line of Kalpit Patel with Wolfe Research. Please go ahead.
Hey, good afternoon and thanks for taking my question. Just one from us on the prostate cancer program: can you give a little more granularity on what to expect in the fourth quarter? Is it just PSA response data, or will we see rPFS data as well? And what would success look like to you in that area?
We expect to provide additional data that could include PSA50 data as well as updated progression-free survival data and subgroup analyses. We will also present data from the 240 milligram dose. Data from the 300 milligram dose may not be mature enough to present yet. Regarding what would be encouraging for rPFS: currently, patients in the second-line setting after progression on prior abiraterone can expect a median PFS of roughly 5 to 6 months; similar expectations apply with docetaxel. A minimum bar would be to improve PFS by 3 to 4 months versus those options. Pluvicto in this space can provide north of 10 months, so our expectation would be at least to be comparable to Pluvicto, with advantages versus Pluvicto if possible. Demonstrating a clear improvement of several months in PFS would be encouraging.
Okay, super helpful. Thank you.
Your next question comes from the line of Gil Blum with Needham. Please go ahead.
Hi, this is Jonathan on for Gil. Quick question about the secondary manufacturing site: for the supplemental filing, what timeline do you expect for hearing back from the FDA? Is it similar to an sNDA timeline, and if this site is approved, what percent of supply would you expect would be coming from the second site at full capacity?
There are multiple processes and steps in the review, and it can be variable. The review can be as brief as two months or it could follow a standard 4-month review timeline; if issues arise, it can take longer. As you interact with the agency during the process, you'll gain an understanding from initial feedback about any matters to address. Regarding supply, it is a tactical matter. We will be using inventory from both sites and managing inventory accordingly. It's important to keep both sites active, and we will balance the mix of product between the two sites to create an operational rhythm.
Your next question comes from the line of Stephen Willey with Stifel. Please go ahead.
Yes, good afternoon. Thanks for taking the questions. Curious where you are in terms of preparing a publication of the mutant data, and whether you believe compendia listing for use of these patients could be achieved before formal label expansion. Also, how are you thinking about communicating launch progress to the Street and what metrics you might provide over the next few quarters?
We have submitted a manuscript to a peer-reviewed journal; the peer-review process can be variable in timing — it can take three months or six months. We hope for the shorter range, but timing is variable and not entirely under our control. Regarding compendia or guideline recommendations for mutant usage: guideline panels, including NCCN, typically rely on peer-reviewed published data for formal recommendations; they generally will not change recommendations based solely on conference presentations. If data are published and the panel makes a recommendation, payers often follow those recommendations, which can affect reimbursement and physician prescribing. As for launch progress, we will report sales as we go. However, the granularity of data for an IV, buy-and-bill therapy is limited compared to oral therapies: we ship to sites and do not receive prescriber-level data as you would with an individual prescription for an oral drug. We will conduct survey data to gain visibility on the treated patient population, which may cover about 40% to 50% of patients treated, but there will be a lag of two to three months. Internally, we will track shipments and vials shipped to sites in real time, which we expect to represent demand. We do not anticipate material inventory buildup, as our 3PL will deliver product overnight in most cases, and some larger sites may maintain limited on-site inventory of about a cycle's supply.
Your next question comes from the line of Silvan Tuerkcan with Citizens. Please go ahead.
Hey, this is Josh on for Silvan. Thanks for taking the question. You mentioned plans to submit the sNDA for the mutant population in Q3. Could you walk us through potential regulatory timelines from submission to filing and the potential for a priority review?
Because this is an sNDA, once the final submission is made and accepted, the review clock starts. If the submission receives priority review, the FDA review would be six months from submission. If it receives a standard review, the timeline would be ten months from submission.
I am showing no further questions at this time. I would like to turn the call back to Brian F. Sullivan for closing remarks.
Thank you for participating in our call today and for your ongoing support. We look forward to seeing many of you at conferences over the next few months. Take care.
Ladies and gentlemen, this concludes today's conference call. Thank you all for joining. You may now disconnect.