Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumors and proprietary diagnostic testing platforms.

# Company Summary: Celcuity Inc.

## Overview
- **Industry:** Biotechnology / Cancer Therapeutics and Diagnostics
- **Focus:** Development of targeted therapies for solid tumors and proprietary diagnostic testing platform

## Core Business Activities
- **Drug Development:** 
  - Lead candidate: **Gedatolisib**, a potent small molecule inhibitor targeting the PI3K/mTOR pathway
  - Mechanism: Inhibits all Class I PI3K isoforms (p110α, β, γ, δ) and mTOR complexes (C1 & C2)
  - Differentiation: Overcomes resistance mechanisms seen with single-node PI3K or mTOR inhibitors
  - Delivery: Administered via intravenous infusion, administered on a cycle of 3 weeks on / 1 week off

- **Clinical Trials & Programs:**
  - **Breast Cancer (HR+/HER2-)**
    - Phase 3 trial (VIKTORIA-1): Enrolled patients whose disease progressed after prior CDK4/6 therapy
    - First patient dosed: December 2022
    - Enrollment goal: ~701 patients across 200+ sites globally
    - Expected topline data: Q2 2025 for PIK3CA-WT group; Q4 2025 for PIK3CA-MT group
  - **Prostate Cancer (mCRPC)**
    - Clinical trial: Phase 1b/2 of gedatolisib combined with darolutamide
    - First patient dosed: February 2024
    - Enrolled: Up to 54 participants
  - **Other Programs:**
    - Phase 3 trial (VIKTORIA-2): First-line treatment in HR+/HER2- breast cancer, planned to dose first patient Q2 2025
  
- **Diagnostic Platform:**
  - **CELsignia:** Proprietary diagnostic platform characterizing oncogenic signaling (including PAM pathway) in live patient tumor cells
  - Focus: Developing companion diagnostics and stand-alone tests
  - Status: In early commercialization, with licensed patents and proprietary know-how

## Licensing & Intellectual Property
- **Pfizer License:** Exclusive global rights to gedatolisib with milestone and royalty obligations
- **Patents:** 
  - Gedatolisib: 12 U.S. patents (expires December 2029, with extensions) and over 290 foreign patents
  - CELsignia: 6 issued U.S. patents and 30 international patents (earliest expiring 2033)

## Employees & Revenue
- **Employees:** 87 full-time employees (as of December 31, 2024)
- **Revenue:** None (no revenue has been generated historically; company is in clinical development stage)
- **Market Capitalization:** Approximate equity market value: **$530.2 million** (based on June 28, 2024 stock closing price of $16.38)
- **Stockholders:** As of March 24, 2025, 37,839,392 shares of common stock outstanding
- **Stock Listing:** Nasdaq Capital Market (Ticker: CELC)

## Summary
Celcuity Inc. is a clinical-stage biotech company developing a novel PI3K/mTOR inhibitor—gedatolisib—for solid tumor cancers, primarily breast and prostate cancers. The company also owns proprietary diagnostic tools (CELsignia) to identify patients likely to benefit from targeted therapies. It is currently conducting multiple late-stage clinical trials with plans for commercial development, but has yet to generate revenue or profit. The company operates with approximately 87 employees and is publicly traded with a market cap around $530 million.

Celcuity Inc. is a clinical-stage biotechnology company developing targeted therapies for cancer, notably through its lead candidate gedatolisib.

# Celcuity Inc. Overview

## Company Description
Celcuity Inc. is a clinical-stage biotechnology company headquartered in Minneapolis, Minnesota. The company focuses on developing targeted therapies for a range of solid tumor indications, primarily through its lead therapeutic candidate, **gedatolisib**. This drug is a small-molecule reversible inhibitor that targets all Class I isoforms of phosphatidylinositol-3-kinase (PI3K) and both mechanistic target of rapamycin (mTOR) sub-complexes (mTORC1 and mTORC2). 

## Targeted Indications
Celcuity's initial clinical development programs for gedatolisib are centered on:

- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
- Metastatic castration-resistant prostate cancer (mCRPC).

## Clinical Development
As of **December 31, 2023**:
- 492 patients with solid tumors have received gedatolisib across **eight completed clinical trials**.
- Notably, **129 patients** were treated with gedatolisib as a standalone agent in three clinical trials.

### Key Clinical Trials
- **Phase 3 Trial (VIKTORIA-1)**: Initiated in December 2022, this trial aims to study the efficacy of gedatolisib combinations in patients whose disease has progressed after prior CDK4/6 therapy.
- **Phase 1b/2 Trial (CELC-G-201)**: Launched in February 2024, focusing on gedatolisib in combination with darolutamide in mCRPC patients.

## Regulatory Designations
- Gedatolisib has received **Fast Track Designation** (January 2022) and **Breakthrough Therapy Designation** (July 2022) from the FDA for the treatment of HR+/HER2- metastatic breast cancer post-CDK4/6 therapy.

## Company Statistics
- **Employees**: As of December 31, 2023, Celcuity employs **55 full-time staff**, primarily in research and development roles.
- **Revenue**: The company has had **no revenue** since its inception in 2012 and has reported significant operating losses.
- **Financial Strategy**: The company finances its operations through equity and debt offerings.

## Current and Future Goals
Celcuity aims to leverage its proprietary **CELsignia diagnostic platform**, which characterizes oncogenic signaling pathways in living tumor cells. The success of the platform is expected to enable the identification of suitable patient populations for gedatolisib and possibly other therapies.

## Market Potential
The market opportunities for Celcuity are considerable given the high prevalence of breast and prostate cancers. The company is actively seeking collaborations with pharmaceutical partners to enhance its potential for additional diagnostic and therapeutic developments.

### Summary
Overall, Celcuity Inc. represents a promising player in the biotechnology space, focusing on innovative cancer treatments and diagnostics, with a clear strategy for clinical development and regulatory approval. However, the company faces significant challenges in achieving profitability, managing clinical trials, and navigating the competitive landscape of cancer therapies.

Celcuity Inc.

10-K / March 31, 2025

10-K / March 27, 2024

10-K / March 31, 2025

Company Summary: Celcuity Inc.

Overview

Core Business Activities

Licensing & Intellectual Property

Employees & Revenue

Summary