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Celcuity to Hold Conference Call to Discuss Results for the PIK3CA Mutant Cohort of the Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib Regimens in HR+/HER- Advanced Breast Cancer on June 2, 2026

Key Takeaway: Celcuity Inc. will host a conference call on June 2, 2026, to discuss results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial. The trial evaluates gedatolisib, a kinase inhibitor, in patients with HR+/HER2- advanced breast cancer. The call will provide insights into the efficacy and safety of gedatolisib in this patient population.
Price reaction · baseline $132.88 (2026-05-29 close) · 3 other CELC headline(s) in the window, move may be shared
day 0 close
-7.5%
day 1 · peak
-31.2%
day 3
-30.4%

Market Sentiment Analysis

POSITIVE FACTORS

  • Celcuity is actively developing targeted therapies for solid tumors.
  • The upcoming conference call will provide important trial results.
  • Gedatolisib shows promise in treating advanced breast cancer.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+27%
120-day peak, hindsight
Typical move
14.9%
average across 6 past catalysts
Cash runway
~41 mo
Minimal dilution risk
Lead asset
Gedatolisib
Phase 3 · Breast Cancer

Full Press Release Details

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 thePIK3CAmutant 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 webcasthere, or register in advance for the teleconferencehere. 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 withPIK3CAwild-type (“WT”) tumors, and announced topline results for Study 2, which evaluated patients withPIK3CAmutant-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 atClinicalTrials.gov. Celcuity is headquartered in Minneapolis, Minnesota. Further information about the Company can be found atwww.celcuity.com. Follow us onLinkedInandX.

Frequently Asked Questions

What is the purpose of the conference call?

The conference call aims to discuss results from the PIK3CA mutant cohort of the VIKTORIA-1 clinical trial.

When will the conference call take place?

The conference call is scheduled for June 2, 2026, at 8:00 a.m. EDT.

What is gedatolisib used for?

Gedatolisib is a kinase inhibitor targeting the PAM pathway, used in advanced breast cancer treatment.

What types of breast cancer does the trial focus on?

The trial focuses on hormone receptor positive (HR+) and HER2 negative (HER2-) advanced breast cancer.

Last updated: Jun 1, 2026