Key Highlights

  • Loss per share was USD 0.73 against USD 0.44 estimated, and no Revenue was recognized against USD 15.33 million estimated.
  • Net loss was USD 42.7 million against USD 24.6 million, and nine-month net loss was USD 117.3 million.
  • Cash, cash equivalents, restricted cash and marketable securities were USD 198.5 million, with Working Capital of USD 172.4 million.
  • The filing describes Patent litigation, a securities class action and Shareholder demands, and a PDUFA date of November 22, 2026.

Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company developing cell therapies, reported a third quarter 2026 loss of USD 0.73 per share against an estimated loss of USD 0.44. No revenue was recognized in the third quarter of 2026 or 2025, against a USD 15.33 million revenue estimate. Net loss was USD 42.7 million against USD 24.6 million a year earlier.

For the nine months, net loss was USD 117.3 million against USD 74.9 million. The filing attributes a USD 50.2 million increase in cash used in Operating Activities largely to a USD 42.5 million increase in net loss. The accumulated Deficit was USD 422.2 million.

Regulatory Review and Clinical Data

Management said the FDA agreed to review additional data and a major amendment to the company's Biologics license application for deramiocel, and extended the PDUFA target action date to November 22, 2026. It said all requested information has been submitted and the review remains ongoing.

Management said the full HOPE-3 results were published in The Lancet in July and that the trial met its primary efficacy endpoint of a statistically significant slowing of upper limb disease progression. A group of 28 Duchenne clinicians and researchers, including HOPE-3 investigators, sent a letter to the FDA that they have since made public, and management said robustness analyses submitted to the FDA ran more than 900 reanalyses of the HOPE-3 data. It also cited open-label extension data from year two of the HOPE trial and an integrated analysis of two placebo-controlled trials that favored deramiocel on ejection fraction by about 2.2 percentage points.

Cash and Liabilities

Cash, cash equivalents, restricted cash and marketable securities totaled about USD 198.5 million at September 30, 2026. Total liabilities were about USD 120.6 million, consisting of about USD 92.2 million of Lease liabilities, USD 16.4 million of Accounts Payable and accrued expenses and USD 12.0 million of deferred revenue, with net working capital of about USD 172.4 million. The filing states that, based on its current operating plan, the company believes existing cash and securities fund operations for at least the next 12 months.

Legal Disclosure and Items to Follow

The filing describes a patent infringement and declaratory judgment action filed July 16, 2026 in the District of Delaware by Mesoblast alleging infringement of three patents relating to mesenchymal stem cell compositions. It also describes a putative securities class action filed September 28, 2026 in the Southern District of California against the company and two officers, shareholder litigation demands, and employment-related claims from former employees. These matters are reported as stated and are flagged for human legal review.