Capricor Therapeutics announced less-than-stellar Q4 2021 and full-year 2021 financial results and said the company stopped efforts on its COVID-19 vaccine.
Capricor Therapeutics announced less-than-stellar Q4 2021 and full-year 2021 financial results today. In addition to disappointing financial reports, Capricor said it was halting efforts on its COVID-19 vaccine to focus on other exosomal therapeutics and its Duchenne muscular dystrophy cell therapy program.
Capricor, a biotech company that develops exosome-based therapeutics for a broad range of diseases, has had generally positive results from its therapies. In August 2021, the company announced it was working with the U.S. Army to publish a study on the use of cardiosphere-derived exosomes to mitigate kidney damage and promote new blood vessel formation after acute trauma. The treatment also served as an anti-shock medication.
In this most recent news, Capricor made what appeared to be a business decision to end development of its exosome-mRNA vaccine for COVID-19. Capricor CEO Linda Marbán, Ph.D. said the decision was made based on “the current availability of vaccines for COVID-19.”
The mRNA-based vaccine had shown promise. In November 2020, Capricor announced positive preclinical data on the vaccine.
Despite this, Capricor is still very much in the COVID-19 game. The U.S. Food and Drug Administration accepted Capricor’s investigational new drug (IND) application in August 2020 for a Phase II clinical trial of lead asset CAP-1002 as a therapeutic for patients with severe COVID-19. CAP-1002 is an exosomal allogeneic cell therapy with immunomodulatory properties.
Capricor is already assessing CAP-1002 in trials for Duchenne muscular dystrophy and believes the properties may help with COVID-19 symptoms as well. The company has completed enrollment in the Phase II INSPIRE study and plans to have top-line data available by the end of this quarter.
CAP-1002 made up the breadth of good clinical news in the Q4/full-year 2021 report. The treatment has produced consistently positive results in treating Duchenne muscular dystrophy. In September 2021, Capricor shared positive final data from its Phase II HOPE-2 clinical trial. In patients diagnosed with Duchenne muscular dystrophy and treated with CAP-1002, muscle degeneration slowed significantly and patients retained upper limb function for longer. The pro-immune response from CAP-1002 also benefited patients with regenerated skeletal and muscle cells and anti-fibrotic properties.
Craig McDonald, MD, the national principal investigator for the HOPE-2 clinical trial and UC Davis professor and chair of the Department of Physical Medicine and Rehabilitation, called the study “groundbreaking” and “extremely exciting” for patients.
The Q4/full-year 2021 report said that the upcoming HOPE-3 trial had received $30 million in additional funding, with the potential of another $705 million coming from an exclusive partnership for commercialization and distribution of CAP-1002 with Kyoto-based Nippon Shinyaku that was established in January 2022.
Other critical aspects of the report included dismal financial updates. In 2021, Capricor reported a $20 million net loss, partially due to increased operating expenses. By cutting costs associated with the COVID-19 vaccine, Capricor hopes to focus funding on its Duchenne muscular dystrophy studies. If the plan succeeds, the company said “the cash and cash equivalents will be sufficient to cover expenses and capital requirements for at least two years” to continue its work.
