Press Releases June 1, 2026 08:30 AM

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

Celcuity to discuss pivotal Phase 3 VIKTORIA-1 trial results for Gedatolisib in HR+/HER2- advanced breast cancer

By Avery Klein
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CELC

Celcuity Inc., a clinical-stage biotech company, announced a conference call on June 2, 2026, to discuss results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 clinical trial. This trial evaluates Gedatolisib, a novel PI3K/mTOR inhibitor, in combination regimens for treating hormone receptor positive, HER2-negative advanced breast cancer. The company is advancing targeted therapies for solid tumors and continues ongoing studies for breast and prostate cancers.

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
CELC
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Key Points

  • Celcuity will present detailed results from the PIK3CA mutant cohort in the Phase 3 VIKTORIA-1 trial evaluating Gedatolisib regimens in HR+/HER2- advanced breast cancer.
  • Gedatolisib uniquely targets all class I PI3K isoforms and mTOR complexes, potentially offering comprehensive inhibition of the PAM pathway, differentiating it from current therapies.
  • Ongoing Phase 3 and Phase 1b/2 trials assess Gedatolisib combinations in hormone receptor-positive advanced breast and prostate cancers, reinforcing Celcuity's focus on targeted oncology therapies.

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 the PIK3CA mutant 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 webcast here, or register in advance for the teleconference here. 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 with PIK3CA wild-type (“WT”) tumors, and announced topline results for Study 2, which evaluated patients with PIK3CA mutant-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 at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis, Minnesota. Further information about the Company can be found at www.celcuity.com. Follow us on LinkedIn and X.

Contacts: 

Celcuity Inc. 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com  
(763) 392-0123  
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924


Risks

  • Clinical trial outcomes may not meet efficacy or safety expectations, impacting regulatory approval and commercial viability in oncology markets.
  • Competition from other targeted therapies for HR+/HER2- breast cancer and metastatic prostate cancer may limit Gedatolisib's market penetration.
  • Dependence on clinical trial progression and regulatory decisions introduces timeline and financial uncertainties affecting biotechnology and pharmaceutical sectors.

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