I need to read more of the filing to get the substantive financial content. Let me work with what's provided, which includes the cover page and forward-looking statements section but limited financial data. I'll use what's available. The filing does contain substantive disclosure content (company identity, share count, filing period, drug name REVTORPYK, clinical trial details, etc.) - more than 150 words of substantive content.

Celcuity Inc. filed its quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission on August 13, 2026, covering the quarterly period ended June 30, 2026, and disclosing key operational and regulatory details for the commercial-stage biopharmaceutical company.

Key Highlights

  • Shares outstanding: As of August 6, 2026, Celcuity reported 48,931,908 shares of common stock outstanding.
  • FDA-approved product: The company disclosed it holds FDA approval for REVTORPYK (gedatolisib) and is pursuing supplemental NDAs for additional indications.
  • Active clinical trials: Celcuity reported ongoing VIKTORIA-2 Phase 3 and CELC-G-201 Phase 1b/2 clinical trials for gedatolisib.
  • License agreement: The company holds exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer Inc. dated April 8, 2021.
  • Filer classification: Celcuity identified itself as a non-accelerated filer and smaller reporting company for this period.
  • Exchange listing: Common stock is listed on NASDAQ:CELC with a par value of $0.001 per share.

Celcuity's Q2 2026 Disclosures: REVTORPYK Commercialization and Clinical Pipeline

Celcuity Inc. (NASDAQ:CELC), headquartered at 2800 Campus Drive, Suite 140, Minneapolis, Minnesota 55441, filed its Form 10-Q for the quarterly period ended June 30, 2026. According to the filing, the company holds FDA approval for REVTORPYK (gedatolisib) and is working to obtain approvals for supplemental NDAs as well as regulatory clearances to commercialize the product outside the United States. The filing also noted that the company is continuing to pursue reimbursement from third-party payors and government programs, including Medicare and Medicaid, for REVTORPYK.

The company disclosed that gedatolisib is licensed exclusively on a global basis under an agreement with Pfizer Inc. dated April 8, 2021. According to the filing, Celcuity holds expectations regarding future payments that may be owed to Pfizer under that License Agreement. The filing also referenced data from the PIK3CA mutant-type cohort of the completed VIKTORIA-1 Phase 3 clinical trial, alongside its two ongoing studies: the VIKTORIA-2 Phase 3 and the CELC-G-201 Phase 1b/2 clinical trials.

The filing contains forward-looking statements, which the company cautioned are "subject to certain risks and uncertainties that could cause our actual business, prospects and results of operations to differ materially." Readers are directed to the risk factors in the company's Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026, as well as to the risk factors section of this quarterly report. As of August 6, 2026, the company reported 48,931,908 shares of common stock outstanding, and identified itself as a non-accelerated filer and smaller reporting company under SEC definitions.

What Was Disclosed

Celcuity filed its June 30, 2026 quarterly report disclosing its FDA-approved product REVTORPYK (gedatolisib), two ongoing clinical trials, an exclusive global license with Pfizer Inc. dated April 8, 2021, and 48,931,908 shares of common stock outstanding as of August 6, 2026.