Celcuity(CELC -0.92%) reported second quarter 2025 results on Aug. 14, 2025, highlighted by top-line Phase III data for gedatolisib in second-line HR-positive, HER2-negative advanced breast cancer. The company ended the quarter with $455 million in pro forma cash after raising $286.5 million in new financing, and plans to file a New Drug Application (NDA) with the FDA in 2025. Key milestones and strategic updates position Celcuity for a potential solo commercial launch pending regulatory approval.
Gedatolisib delivers unprecedented Phase III efficacy
Gedatolisib demonstrated a median progression-free survival (PFS) of 9.3 months for the triplet regimen and 7.4 months for the doublet in the PIK3CA wild-type cohort of the VICTORIA-1 trial, compared to 2 months for fulvestrant alone. Prior Phase III studies in this post-CDK4/6 population reported only 1.7 to 3.9 months of incremental median PFS, with hazard ratios between 0.55 and 0.73, underscoring the magnitude of Celcuity's results.
"Median progression-free survival, or PFS, for the gedatolisib triplet was 9.3 months compared to only 2 months for fulvestrant, a 7.3-month incremental improvement in median PFS. The hazard ratio was 0.24, which translates to a 4.2 times higher likelihood of survival without disease progression for the gedatolisib triplet than fulvestrant. For the gedatolisib doublet, median PFS was 7.4 months, again, compared to only 2 months for fulvestrant, a 5.4-month incremental improvement in median PFS. The hazard ratio was 0.33, which translates to a 3 times higher likelihood of survival without disease progression for the gedatolisib doublet than fulvestrant. Now, these results established several new milestones in the history of drug development for this patient population. First, the hazard ratios reported for both the gedatolisib triplet and doublet were the most favorable ever reported by any Phase III trial, first-line, second-line, or third-line, in this population. And second, the incremental improvements in median PFS for the triplet and doublet, 7.3 and 5.4 months, respectively, were the highest ever reported by any Phase III trial for this patient population receiving at least their second line of therapy for advanced disease."
— Brian Sullivan, Chief Executive Officer
This efficacy profile positions gedatolisib as a potential new standard of care, expanding Celcuity's addressable market and competitive advantage in second-line advanced breast cancer.
Celcuity secures long-term exclusivity and funding
In July and August, Celcuity raised $286.5 million in net proceeds from offerings of convertible notes, common stock, and prefunded warrants, increasing pro forma cash reserves to $455 million at quarter-end. The company also gained a new U.S. patent on gedatolisib's clinical dosing regimen, extending exclusivity until at least 2042 and strengthening its intellectual property position for more than 16 years beyond 2025.
"First, the US Patent and Trademark Office issued Celcuity Inc. a new patent covering the clinical dosing regimen for gedatolisib in HR-positive HER2-negative breast cancer patients. The patent extends gedatolisib's patent exclusivity in the US into 2042. With this added patent exclusivity, we expect to have a long runway to optimize the development of gedatolisib. And last but not least, we also completed concurrent offerings of convertible notes, common stock, and prefunded warrants with net proceeds of $286.5 million in July and August. With current resources and other financing arrangements, we believe we are well-positioned to advance multiple blockbuster indications in breast and prostate cancer and to aggressively prepare for and launch gedatolisib commercially should we receive FDA approval."
— Brian Sullivan, Chief Executive Officer
With extended patent protection and a robust cash position, Celcuity is equipped to independently execute clinical, regulatory, and commercial strategies without near-term reliance on partners or dilutive capital raises.
Celcuity builds commercial infrastructure for solo launch
Celcuity began building its commercial organization in 2024, hiring key leadership in marketing, market access, and operations, and has continued to expand these teams in preparation for a 2026 launch. Management emphasized the importance of hiring leaders with first-in-class launch experience to ensure operational readiness and strategic control over product positioning and payer engagement.
"First, we began building our team last year. We hired our Chief Commercial Officer, Elton Meyer, in 2024. And then he, in turn, brought on board a head of marketing, head of market access, head of commercial operations. And they focused on projects that have a long lead time, and there are a variety of those. It can take up to eighteen months to get done. And so, essentially, we've been working back from a launch date. You have to assume an earlier launch date or you're kind of aggressive on when you think that'll occur just so you're not blindsided. And you're ready under any circumstance. And now as we've gotten closer to launch, these past few months, we've begun hiring the individuals who report up to the heads of these various departments. And in turn, they can take on more projects. Now that we have our data, we have what we think is a clear path to an approval decision, which we can kind of where we can define with some degree of confidence a launch date. We'll be taking that next step. And so that'll involve additional infrastructure associated in the commercial operations area to support Salesforce, to support the Salesforce. There's activities in the market access area, engaging with payers, strategic accounts, in ways that are appropriate at this stage. And then in turn, you start to build out your Salesforce management structure, starting with a head of sales and then regional management, which in turn requires you to define sales territories, number of territories, the geographic alignment, etcetera. So all those projects are on track. And as far as how are we doing, what is our benchmark? We've been very deliberate about hiring folks in all of these key positions, people who have been involved in the first launch of a company's drug, first drug launch for a company. And that's critical because there's so much infrastructure, operational support activities that are required to be effective as a commercial organization. It's not a plug and play. Somebody coming from big pharma has never had to set up all of this infrastructure or to establish these processes and these functions from scratch. So I think we've been very, very fortunate. We've hired a great team, incredibly experienced, very focused, and I think we're absolutely on track to having what we think, you know, we're optimistic about the launch and our ability to be very, very effective in communicating the benefits of gedatolisib, what we believe are the benefits of gedatolisib to medical oncologists."
— Brian Sullivan, Chief Executive Officer
This deliberate approach to organizational buildout enables Celcuity to retain U.S. commercialization economics and maintain full strategic control over launch execution.
Looking Ahead
Celcuity plans to submit a U.S. NDA for gedatolisib in 2025, present full PIK3CA wild-type Phase III data at a medical conference later this year, and release top-line PIK3CA-mutant cohort data by year-end 2025. Management expects current resources to fund operations through 2027, supporting solo launch preparations. No concrete revenue or sales volume guidance was provided for 2026 or beyond in this earnings call.
