What Celcuity (CELC) said on its Q3 earnings call. November 5, 2026 Key points. * REVTORPYK's launch showed early traction: 78% of Celcuity's 36 strategic accounts had ordered the drug, health plans covering 91% of U.S. commercial and Medicare lives covered it, and it was added to three of four major provider pathways. No product revenue was recorded in Q3 because shipments began on the quarter's final day and had not yet reached treatment sites. * Higher launch-related costs widened the loss: Celcuity reported a Q3 net loss of $73.3 million, up from $43.8 million a year earlier, as operating expenses rose to $77.3 million. The company ended the quarter with $642.7 million in cash and investments and expects that balance to fund operations through 2029. * Clinical and regulatory programs advanced: Celcuity submitted an FDA application based on the PIK3CA-mutant VIKTORIA-1 cohort and expects further regulatory submissions and trial updates. Overall-survival data from VIKTORIA-1 are anticipated in the first half of 2027, though timing is event-driven. * Five stocks we like better than Celcuity. Celcuity NASDAQ: CELC reported a wider third-quarter loss as it prepared to commercialize its breast cancer treatment REVTORPYK, while executives said early orders and insurance coverage pointed to an encouraging launch. The company recorded no product revenue in the quarter ended Sept. 30, 2026. Shipments began on the final day of the quarter, but none reached treatment locations until afterward, Chief Financial Officer Vicky Hahne said on the earnings call. Chief Executive Officer and Co-Founder Brian Sullivan said Celcuity expects to provide a preliminary report on fourth-quarter sales in mid-January. The company's net loss for the third quarter widened to $73.3 million, or $1.33 per share, from $43.8 million, or $0.92 per share, a year earlier. Early launch and market access. REVTORPYK is available in the U.S. in combination with fulvestrant, with or without palbociclib, for certain patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation after progression on or following endocrine therapy in the metastatic setting. Sullivan said 78% of Celcuity's top 36 strategic accounts had ordered REVTORPYK since it became commercially available on Sept. 30. Those accounts treat roughly half of the addressable patient population, he said. More than 3,400 sites had engaged directly with the company's oncology sales specialists, while more than 1,100 health care providers had attended educational programs. Health plans covering 91% of U.S. commercial and Medicare lives cover the treatment, Sullivan said. He also said REVTORPYK had been incorporated into three of the four largest health care provider pathways within 30 days of commercial availability. Shipments began at a wholesale acquisition cost of $10,000 per vial, or $30,000 per 28-day treatment cycle. Sullivan estimated a roughly $9 billion annual U.S. market for second-line treatment, including patients with and without PIK3CA mutations, based in part on an assumed net receipt of 80% of the list price. The drug is not currently approved for patients with PIK3CA mutations. Because most providers are expected to order the infused drug through specialty distributors using a buy-and-bill system, Celcuity does not receive detailed data on the number of prescribers or patients, Sullivan said. He described reports that physicians favor the three-drug regimen as anecdotal. Discover more MarketBeat All Access Stock Market News Stock Screener Tool Sullivan said the company has sufficient production to meet planned or higher-than-planned demand. A second manufacturing site is not expected to be approved until around the middle of 2027, he said. Clinical and regulatory updates. Celcuity submitted a supplemental new drug application to the Food and Drug Administration in the third quarter based on results from the PIK3CA-mutant cohort of the Phase 3 VIKTORIA-1 study, Sullivan said. The company expects to submit data from both the mutant and wild-type cohorts to global regulators later this year or early next year. At the European Society for Medical Oncology meeting in October, the company presented updated results from the mutant cohort. Among patients without liver metastases, median progression-free survival was 21.5 months for the gedatolisib triplet and 11.5 months for the doublet, compared with 9.1 months for alpelisib plus fulvestrant, Sullivan said. He added that the rate of discontinuation of gedatolisib because of adverse events was 5% for the triplet and 4% for the doublet, compared with a 19% discontinuation rate for alpelisib plus fulvestrant. Sullivan said Celcuity expects to provide further VIKTORIA-1 updates at the San Antonio Breast Cancer Symposium later this year. The company expects overall survival data from VIKTORIA-1 in the first half of 2027, although the timing is event-driven, Sullivan said. He cautioned that crossover in the wild-type cohort could complicate interpretation of the results. Celcuity is also conducting the Phase 3 VIKTORIA-2 trial in first-line advanced breast cancer and developing a subcutaneous formulation of gedatolisib. A randomized Phase 2 study of gedatolisib with darolutamide in metastatic castration-resistant prostate cancer is expected to begin in the first half of 2027, following completion of the Phase 1b portion of the current study. Commercial spending drives expenses higher. Third-quarter operating expenses rose to $77.3 million from $42.8 million a year earlier. Research and development expenses increased to $37.5 million from $30.4 million, while selling, general and administrative expenses rose to $39.8 million from $12.4 million. Hahne said $25.3 million of the increase in selling, general and administrative expenses related to commercial hiring and other activities supporting the REVTORPYK launch. The company also made a $50 million payment to Pfizer triggered by FDA approval under its gedatolisib license agreement. Celcuity ended the quarter with $642.7 million in cash, cash equivalents and short-term investments, compared with $441.5 million at the end of 2025. Hahne said the balance reflected proceeds from a convertible note offering completed in June, offset partly by operating cash use, repayment of a term loan and the Pfizer payment. The company expects its cash and investments to fund operations through 2029. About Celcuity (NASDAQ:CELC). Celcuity, Inc is a clinical-stage biotechnology company developing functional diagnostic tests designed to help identify cancer treatments that may be most effective for individual patients. Its technology analyzes living tumor cells taken from patients to measure how signaling pathways respond to different therapies, with the goal of supporting more personalized treatment decisions. The company's CELsignia platform is designed to assess the activity of cancer-related signaling pathways in patient-derived cells. 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]. Before you consider Celcuity, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Celcuity wasn't on the list. While Celcuity currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. Tesla, Nvidia, and Google helped shape the last era of market growth, but the next wave could come from a new group of companies. Inside this report, you'll find 7 stocks that could play a major role in the next tech-driven market boom. Continue following MarketBeat

Celcuity presented Phase 3 and Phase 1b/2 data at ESMO 2026 showing that its drug gedatolisib improved progression-free outcomes, with manageable safety, in advanced breast and prostate cancer. In the VIKTORIA 1 PIK3CA mutant cohort, gedatolisib-based triplet and doublet regimens showed longer median progression-free survival than alpelisib plus fulvestrant across several high-risk subgroups. They also led to fewer discontinuations due to treatment-emergent adverse events. Regulatory timing remains the key near-term catalyst. Celcuity has no revenue, is running sizeable losses, and carries a term loan and convertible notes. Analysts forecast revenue of $817.9 million and earnings of $267.5 million by 2029, against a current loss of $192.9 million. The most cautious analysts expect $602.1 million in revenue and $103.8 million in earnings.

Celcuity presents updated data from a Phase 1b/2 study evaluating gedatolisib plus darolutamide in men with metastatic castration-resistant Prostate Cancer at the ESMO Congress 2026. Stock score locked: want to see it? Benzinga Rankings give you vital metrics on any stock - anytime. Median radiographic progression free survival ("rPFS") was 15.7 months and the six-month rPFS rate ("rPFS6") was 82.2% in patients who received prior abiraterone Median rPFS was 9.1 months and rPFS6 was 62.5% in patients who received prior enzalutamide The Phase 2 portion of the study evaluating gedatolisib plus darolutamide is expected to begin in the first half of 2027 MINNEAPOLIS, Oct. 23, 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 updated clinical results from the Phase 1b/2 study evaluating gedatolisib in patients with metastatic castration-resistant prostate cancer ("mCRPC"). These data were presented at the European Society of Medical Oncology (ESMO) Congress 2026 today, Friday, October 23, 2026, at 9:15 a.m. EDT/3:15 p.m. CEST at a poster presentation: In this Phase 1b/2 study, 45 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1 (n=19), 180 mg gedatolisib in Arm 2 (n=19) and 240 mg gedatolisib in Arm 3 (n=7). In all arms, gedatolisib was administered intravenously on days 1, 8, and 15 of a 28-day cycle, then two weeks off. Additionally, all patients received prophylactic treatment for stomatitis. Baseline characteristics were generally consistent across dose cohorts; over 50% had bone disease, 33% had phosphatase and tensin hemolog ("PTEN") loss. Data was analyzed as of an August 14, 2026 cut-off date. Key results reported included: * Median rPFS was 15.7 months with an rPFS6 rate of 82.2% in patients with prior abiraterone exposure (n=22). * Median rPFS was 9.1 months with an rPFS6 rate of 62.5% in patients with prior enzalutamide exposure (n=18). * PSA >=50% decreases from baseline ("PSA50") were observed across all dose levels; response rates were 36%, 47% and 67% at the 120-, 180-, and 240-mg gedatolisib dose levels, respectively, in patients with prior exposure to either abiraterone or enzalutamide. * Exploratory analyses of patients according to their PTEN status suggest activity is independent of PTEN status. * Gedatolisib plus darolutamide demonstrated a manageable safety profile across the evaluated dose levels (120 mg, 180 mg, 240 mg) with one dose limiting toxicity (Grade 3 rash), no Grade 4/5 treatment related adverse events ("TRAEs"), and no TRAEs leading to treatment discontinuation or death. Grade 3 TRAEs occurred in 9 (20%) patients with only rash (n=4) and pruritus (n=2) occurring in more than one patient. "We are highly encouraged by these results and believe combining gedatolisib with an androgen receptor inhibitor is a promising new approach for patients with mCRPC," said Igor Gorbachevsky, Chief Medical Officer of Celcuity. "The 82.2% six-month PFS rate and median rPFS of 15.7 months is remarkable in patients who had received prior abiraterone and compares favorably to published data for AR inhibitors in this setting. We look forward to initiating the Phase 2 portion of the study and further evaluating this combination in more patients." The randomized Phase 2 study is expected to evaluate two different groups of patients (Groups 1 and 2) with the objective of determining the recommended phase 3 dose level. Subjects in Group 1 will be those who received prior abiraterone for either hormone sensitive or castration resistant prostate cancer. Subjects in Group 2 will be those who received prior enzalutamide or apalutamide for either hormone sensitive or castration resistant prostate cancer. Celcuity anticipates initiating this study in the first half of 2027 after completion of the Phase 1b part of the study. About Prostate Cancer Prostate cancer is the second most commonly occurring cancer in men with 1.5 million cases diagnosed in 2024 and the fourth most commonly occurring cancer overall worldwide.[1] The American Cancer Society estimates approximately 333,830 men will be diagnosed with prostate cancer in 2026 and over 36,000 will die annually in the U.S.[2] For men diagnosed with metastatic castration-resistant prostate cancer, the 5-year survival rate is 32% and there is a significant need for better treatment options, as median progression-free survival is currently between 6.7 - 5.5 months in the second line setting following AR therapy.[3-5] About Celcuity Celcuity is a commercial-stage 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(TM)(gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) 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 U.S. Food and Drug Administration approval of REVTORPYK for use in patients 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 VIKTORIA-1 have been released. 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. Further information about Celcuity 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 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 Company's clinical strategy, including the benefits of strategic decisions regarding studies and trials; and other expectations with respect to gedatolisib, including potential future indications for gedatolisib regimens. 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; and the development of therapies and tools competitive with gedatolisib. 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 * Sung H, Filho AM, Laversanne M, Ferlay J, Siegel RL, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries. CA Cancer J Clin. 2026 Jul-Aug;76(4):e70090. doi: 10.3322/caac.70090. PMID: 42417444; PMCID: PMC13343830. * American Cancer Society website; Accessed October 2026: https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html * Crabb, J Clin Oncol 2021 * Attard, J Clin Oncol 2018 * Sweeny Clin Cancer Res 2022 Contacts For Investors: Brian Sullivan, [email protected] Vicky Hahne, [email protected] (763) 392-0123 Jodi Sievers, [email protected] (415) 494-9924