Capricor Cuts 10% of Workforce as Operating Expenses Rise to $44.7 Million
Key Facts
Capricor Therapeutics cut about 10% of its workforce during the third quarter of 2026, a move the company said was aimed at reducing operating expenses and aligning resources with its priorities. The announcement came with its quarterly results, as operating expenses and losses rose compared with the same period last year. Expenses totaled $44.7 million, versus $26.3 million in the third quarter of 2025. The company attributed the increase mainly to pre-launch activities and manufacturing expansion. These steps are tied to the Deramiocel program, whose license application remains under FDA review.
The company’s net loss widened to $42.7 million, or $0.73 per share, compared with a loss of $24.6 million, or $0.54 per share, a year earlier. In the first nine months of 2026, the net loss was $117.3 million, or $2.03 per share. The company had reported a loss of $74.9 million, or $1.64 per share, in the corresponding period of 2025. Operating expenses for the nine months also rose to $124.4 million, from $79.0 million in the same period a year earlier. The company said pre-launch activities and manufacturing expansion were the main drivers of the increase in expenses during the period.
Cash, cash equivalents, restricted cash and marketable securities totaled $198.5 million on September 30, 2026, compared with $318.1 million on December 31, 2025. Capricor said its current cash resources were sufficient to fund its operating capital requirements for at least the 12 months following the issuance of its financial statements, based on its current plan. The figures place the higher expenses and workforce reduction in the context of resource management ahead of an important regulatory decision. The company said programs not directly related to Deramiocel, including its exosome platform, had been slowed to prioritize the treatment until the regulatory path becomes clearer. The company did not describe the cuts as a strategic shift dedicated to the drug candidate, but said they were intended to reduce expenses and align resources with its priorities.
Deramiocel is intended to treat Duchenne muscular dystrophy, and its license application is under FDA review. The company set November 22, 2026, as the target action date under PDUFA after the agency classified an amendment to the application as major, extending the review by three months. The review included an agency inspection in July 2026, during which it issued one observation on Form 483; Capricor said it had submitted its response and was awaiting the agency’s feedback. The upcoming regulatory decision is therefore a direct focus for the company after a period of elevated spending and manufacturing preparations. Capricor said it would provide further guidance on its longer-term financial outlook once the regulatory path becomes clearer, and that it would use that outlook in its strategic and capital allocation decisions.
The company’s account of the program draws on clinical data from the HOPE-3 study. In results from the randomized, placebo-controlled Phase 3 trial, it reported that Deramiocel slowed the decline in upper-limb function as measured by PUL 2.0, with statistical significance at p=0.029; the paper was published in July. It also said two-year open-label extension data showed a 76% slowing in the decline in upper-limb function among patients who switched from placebo to Deramiocel, compared with their year on placebo. The company said HOPE-3 cardiac results were generally consistent when compared with a matched natural history data set. Capricor says its manufacturing facility in San Diego is ready to support an initial commercial launch if the treatment is approved. Work is underway to expand the second-floor cleanroom, with qualification targeted for the first half of 2027.
In the stock market, CAPR shares closed at $8.87 on November 10, 2026. The price comes as investors await the outcome of the regulatory application review and monitor the company’s expenses and liquidity. November 22 remains the target date Capricor announced for the FDA’s action on Deramiocel. The company expects to provide longer-term financial guidance once the regulatory path becomes clearer. It also aims to complete qualification of the cleanroom expansion during the first half of 2027.