SAN DIEGO - Capricor Therapeutics (NASDAQ: NASDAQ:CAPR), a biotechnology firm focused on cell and exosome-based therapies for rare diseases, announced today the launch of an underwritten public offering of its common stock. The company is also giving underwriters a 30-day option to buy additional shares up to 15% of the total sold in the offering. The offering's completion, size, and terms are contingent on market conditions and are not guaranteed.
Joint book-running managers Piper Sandler and Oppenheimer & Co. are overseeing the public offering. Capricor plans to allocate the net proceeds toward advancing its product candidates, manufacturing, working capital, and general corporate purposes.
The offering is pursuant to a shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) on June 14, 2024, and declared effective as of today. Details of the offering are available in a preliminary prospectus supplement filed with the SEC today, with a final prospectus supplement to follow.
Capricor's lead product candidate, deramiocel (CAP-1002), is an allogeneic cardiac-derived cell therapy currently in Phase 3 clinical development for Duchenne muscular dystrophy. The company's proprietary StealthX™ platform is being explored in preclinical studies for various potential applications, including vaccines and targeted delivery systems.
The press release clarifies that this announcement does not constitute an offer to sell or a solicitation of an offer to buy securities. Sales of these securities are not permitted in any jurisdiction where such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that jurisdiction.
Capricor's commitment to advancing treatments for rare diseases is emphasized, yet it is important to note that their product candidates, including deramiocel, have not yet received regulatory approval. The company has an agreement with Nippon Shinyaku Co., Ltd. for the commercialization and distribution of deramiocel in the United States and Japan, pending regulatory consent.
This news is based on a press release statement from Capricor Therapeutics.
In other recent news, Capricor Therapeutics has been making significant strides in its operations. The company is preparing to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration for deramiocel, a treatment for cardiomyopathy in Duchenne muscular dystrophy (DMD) patients. This submission process, which began in October 2024, is expected to conclude by the end of the year.
Furthermore, Capricor Therapeutics is planning a merger of Cohorts A and B from the ongoing Phase 3 HOPE-3 trial for a post-approval study. The company's StealthX™ exosome-based multivalent vaccine for SARS-CoV-2 prevention has also been selected for Project NextGen, a U.S. Department of Health and Human Services initiative.
In financial terms, Capricor Therapeutics raised approximately $15.0 million through a private placement of common stock to Nippon Shinyaku and generated gross proceeds of approximately $53.9 million from selling all available shares under its at-the-market program. Despite reporting a net loss of approximately $11 million for Q2 2024, the company maintains a strong cash position, supported by these financial agreements.
Analysts from Oppenheimer, H.C. Wainwright, and Maxim Group have maintained their positive ratings for Capricor, reflecting optimism surrounding the company's developments. These recent developments underscore the company's commitment to advancing its treatment options and solidifying its financial position.
InvestingPro Insights
Capricor Therapeutics' recent announcement of a public offering comes at a time of significant market momentum for the company. According to InvestingPro data, CAPR has seen an impressive 389.8% price return over the past month and a staggering 659.23% return over the last year. This strong performance aligns with the company's decision to capitalize on market conditions through a public offering.
However, potential investors should be aware of some key financial metrics. InvestingPro Tips highlight that Capricor is not currently profitable, with a negative gross profit margin of -37.73% in the last twelve months as of Q2 2024. The company's revenue, while growing at 187.15% year-over-year, stands at $27.15 million for the same period.
It's worth noting that analysts anticipate a sales decline in the current year, which could impact the company's valuation. Currently, Capricor is trading at a high revenue valuation multiple, reflecting the market's optimism about its future prospects, particularly regarding its lead product candidate, deramiocel.
For investors seeking a more comprehensive analysis, InvestingPro offers 17 additional tips for Capricor Therapeutics, providing a deeper understanding of the company's financial health and market position.
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