Tillkännagivande • May 15

Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients

Celcuity Inc. announced updates to the Phase 3 VIKTORIA-2 clinical trial of gedatolisib as a first-line treatment for patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”). Following last year’s announcement and subsequent data presentation demonstrating clinically meaningful improvement in progression-free survival (“PFS”) for patients treated with gedatolisib combined with palbociclib and fulvestrant compared to those treated with fulvestrant in the PIK3CA wild-type (“WT”) cohort of the VIKTORIA-1 Phase 3 study, several important elements of the VIKTORIA-2 clinical trial protocol have been amended. First, in addition to evaluating patients in the first-line setting with endocrine-resistant HR+/HER2- ABC, VIKTORIA-2 will now include a separate study to evaluate the safety and efficacy of patients in the first-line setting who have endocrine-sensitive HR+/HER2- ABC. Second, patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized to a treatment arm. Third, efficacy analyses for both Study 1 and Study 2 of VIKTORIA-2 will evaluate the entire intent-to-treat population (combined WT and mutant type (“MT”)) enrolled in their respective study. Each study will have independent statistical analysis plans that will include separate primary endpoints. The primary endpoints for the VIKTORIA-2 clinical trial are PFS, per RECIST 1.1 criteria, as assessed by blinded independent central review (“BICR”). Prior to finalizing the amended Phase 3 trial design, Celcuity conducted a Type B meeting with the U.S. Food and Drug Administration (the “FDA”) to obtain their feedback and to gain alignment on these planned amendments. For patients with endocrine-sensitive HR+/HER2- advanced breast cancer who received gedatolisib in combination with palbociclib and letrozole in our Phase 1b clinical trial, median progression free survival was 48.6 months, median overall survival was 77.3 months, and the objective response rate was 79%. Results from the PIK3CA wild-type and mutation cohort of our VIKTORIA-1 study demonstrated the benefit of gedatolisib combination treatment in HR+/HER2- ABC in the second-line setting. Developing the gedatolisib triplet for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status, offers the potential to advance the standard of care for the approximately 90,000 women each year who are diagnosed with late-stage HR+/HER2- ABC. To support its long-term lifecycle development plan, Celcuity also announced that it submitted to the United States Patent and Trademark Office (“USPTO”) its first patent application for a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection as an alternative to an infusion. Development of the 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. Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. More than two million breast cancer cases were diagnosed globally in 2022. While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis. HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers. Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (“PAM”), are primary oncogenic drivers of HR+/HER2- ABC. Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Ka, AKT, or mTORC1. However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research. VIKTORIA-2 is a Phase 3, global, open-label, randomized, clinical trial designed to evaluate the efficacy and safety of gedatolisib plus palbociclib and endocrine therapy as first-line treatment for patients with HR+/HER2- ABC. Patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized 1:1 to either investigational treatment or standard-of-care control. Study 1 is expected to enroll approximately 440 patients with treatment-naïve endocrine-resistant ABC whose cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and fulvestrant (Arm A) compared to ribociclib combined with fulvestrant (Arm B). Study 2 is expected to enroll approximately 740 subjects with treatment-naïve endocrine-sensitive ABC 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. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole (Arm C) compared to ribociclib combined with letrozole (Arm D). The clinical trial primary endpoints for the VIKTORIA-2 clinical trial are PFS, per RECIST 1.1 criteria, as assessed by BICR. This global trial is expected to enroll subjects at up to 200 clinical sites across North America, Europe, and Asia-Pacific. Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.

Tillkännagivande • May 04

Celcuity Inc Announces Positive Topline Results From Phase 3 ViktorIA-1 Clinical Trial Evaluating Gedatolisib Plus Fulvestrant With Or Without Palbociclib In Patients With Hormone Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative PIK3CA Mutant Locally Advanced Or Metastatic Breast Cancer

Celcuity Inc. had announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, PIK3CA mutant locally advanced or metastatic breast cancer, following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Detailed results will be presented in a late-breaking abstract oral session at the American Society of Clinical Oncology Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois. The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to alpelisib, a PI3Ka inhibitor, and fulvestrant. The secondary endpoint comparing gedatolisib plus fulvestrant 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 progression-free survival compared to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and no new safety signals. Celcuity intends to submit these data to the U.S. Food and Drug Administration as a supplemental New Drug Application and to submit VIKTORIA-1 data to other regulatory authorities following the sNDA submission. The FDA has granted Priority Review of Celcuity’s New Drug Application for gedatolisib in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer and assigned a Prescription Drug User Fee Act goal date of July 17, 2026. HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers. Among this breast cancer subtype, approximately 40% have PIK3CA mutations. Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6 and PI3K/AKT/mTOR, are primary oncogenic drivers of HR+/HER2- breast cancer. Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Ka, AKT or mTORC1. However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research. VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant, with or without palbociclib, in adults with HR+/HER2- advanced breast cancer whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is fully enrolled. The trial enrolled subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Detailed results from the PIK3CA wild-type cohort of VIKTORIA-1 have been previously reported. For the PIK3CA mutant cohort, subjects who met eligibility criteria and had confirmed PIK3CA mutations were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet. Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1 and mTORC2 to induce comprehensive blockade of the PAM pathway. As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway. Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data.

Räntetäckningsgrad	n/a
Kontanter	US$387.06m
Eget kapital	US$53.53m
Summa skulder	US$356.64m
Totala tillgångar	US$410.16m

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/05/20 07:07
Aktiekurs vid dagens slut	2026/05/20 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Arlinda Lee	Canaccord Genuity
Silvan Tuerkcan	Citizens JMP Securities, LLC
Alexander Nowak	Craig-Hallum Capital Group LLC

Celcuity Balansräkning Hälsa

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Recent updates

Forecast breakeven date pushed back to 2028

Celcuity’s Gedatolisib Secures FDA Priority Review Following Positive Phase 3 Breast Cancer Results

Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients

Celcuity Inc. to Report Q1, 2026 Results on May 14, 2026

Forecast breakeven date moved forward to 2027

Priority FDA Review And Phase III Data Will Transform This Oncology Pure Play

Price target increased by 8.0% to US$131

Forecast breakeven date moved forward to 2027

Celcuity Inc., Annual General Meeting, May 14, 2026

New major risk - Shareholder dilution

Price target increased by 7.6% to US$126

Single Drug Dependence And Heavy Financing Will Shape A Challenging Future

Celcuity Inc. to Report Q4, 2025 Results on Mar 25, 2026

Celcuity Inc Announces Publication Of Results From PIK3CA Wild-Type Cohort Of Phase 3 VIKTORIA-1 Study Of Gedatolisib Regimens In HR+/HER2- Advanced Breast Cancer

Future Oncology Approvals And Pipeline Expansion Will Support A Stable Long Term Outlook

Celcuity Inc. Appoints Charles Romp to Its Board of Directors

Price target increased by 7.3% to US$114

Independent Director notifies of intention to sell stock

Celcuity Inc. Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

Forecast to breakeven in 2028

Celcuity: After Stellar 2025, I Predict More Success In 2026 And Beyond

Celcuity Inc. Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium

Independent Director notifies of intention to sell stock

Celcuity Inc. Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild- Advanced Breast Cancer

New minor risk - Shareholder dilution

Celcuity Inc. to Report Q3, 2025 Results on Nov 12, 2025

Price target increased by 8.9% to US$81.13

Celcuity Inc. Presents Updated Data At the 2025 Esmo Congress from Phase 1 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration Resistant Prostate Cancer

Co-Founder exercised options to buy US$5.8m worth of stock.

Celcuity Inc. to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA's Real-Time Oncology Review Program

Celcuity Inc. to Report Q2, 2025 Results on Aug 14, 2025

Celcuity Inc. has completed a Follow-on Equity Offering in the amount of $84.999596 million.

Price target increased by 89% to US$55.86

Celcuity Inc. Announces Clinically Meaningful Improvement in Both Progression-Free Survival Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial

New major risk - Share price stability

Celcuity Inc. Announces First Patient Dosed in Phase 3 VIKTORIA-2 Clinical Trial of Gedatolisib as A First-Line Treatment for HR+/HER2- Advanced Breast Cancer

Celcuity Inc. Reports Clinical Data from Two Early Phase Studies of Gedatolisib

Celcuity Inc. to Report Q1, 2025 Results on May 14, 2025

Celcuity Inc., Annual General Meeting, May 13, 2025

Celcuity Inc. to Report Q4, 2024 Results on Mar 31, 2025

New major risk - Shareholder dilution

Celcuity Presents Overall Survival Data from Phase 1B Study Evaluating Gedatolisib in Combination with Palbociclib and Endocrine Therapy At the 2024 San Antonio Breast Cancer Symposium

Celcuity Inc. to Report Q3, 2024 Results on Nov 14, 2024

Celcuity: Breast Cancer Drug Developer With Upcoming Catalysts

Celcuity Inc. to Report Q2, 2024 Results on Aug 14, 2024

Celcuity: Flying A Phase 3 Trial Right Under Your Nose

Celcuity Inc. has completed a Follow-on Equity Offering in the amount of $60.0005 million.

New major risk - Shareholder dilution

Celcuity Inc. Announces Plan to Initiate A Phase 3 Clinical Trial for Gedatolisib as First-Line Treatment for HR+/HER2- Advanced Breast Cancer

Celcuity Inc. to Report Q1, 2024 Results on May 15, 2024

Price target increased by 7.7% to US$29.50

Celcuity Inc., Annual General Meeting, May 09, 2024

Celcuity Inc. to Report Q4, 2023 Results on Mar 27, 2024

Celcuity Announces First Patient Dosed in Phase 1b/2 CELC-G-201 Clinical Trial of Gedatolisib for the Treatment of Metastatic Castration Resistant Prostate Cancer

Price target increased by 11% to US$27.40

Celcuity Appoints Eldon Mayer as Chief Commercial Officer

Celcuity Inc. Presents Preclinical Data on Therapeutic Effects of Gedatolisib in Breast Cancer Models at the 2023 San Antonio Breast Cancer Symposium

New major risk - Revenue and earnings growth

Celcuity Inc. to Report Q3, 2023 Results on Nov 13, 2023

Celcuity Inc. announced that it expects to receive $50 million in funding

Celcuity Inc. Announces Plan to Conduct Phase 1B/2 Clinical Trial in Metastatic Castration Resistant Prostate Cancer

New major risk - Revenue and earnings growth

Celcuity Inc. to Report Q2, 2023 Results on Aug 10, 2023

Independent Director recently bought US$103k worth of stock

Celcuity Inc. to Report Q1, 2023 Results on May 15, 2023

Celcuity Inc. Presents Preclinical Data on Therapeutic Effects of Gedatolisib in Prostate Cancer at ASCO GU Cancers Symposium

Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment of HR+/HER2- Advanced Breast Cancer

Celcuity to Present Additional Data for Gedatolisib At the 2022 San Antonio Breast Cancer Symposium

Price target decreased to US$24.00

Insufficient new directors

Celcuity Inc. Appoints Polly A. Murphy to its Audit Committee and Its Compensation Committee

Celcuity Inc. to Report Q3, 2022 Results on Nov 10, 2022

Celcuity Inc. Appoints Polly Murphy to Board of Directors

Celcuity Inc. to Report Q2, 2022 Results on Aug 11, 2022

Celcuity rises after hours on FDA Breakthrough Therapy nod for its breast cancer treatment