SAN DIEGO – Capricor Therapeutics (NASDAQ: NASDAQ:), a biotechnology company focused on the development of cell and exosome-based therapeutics for rare diseases, announced it will host an investor webcast on Tuesday to discuss recent regulatory developments concerning its Duchenne muscular dystrophy (DMD) program.

The webcast, scheduled for 8:30 a.m. ET, follows the company’s recent interactions with the U.S. Food and Drug Administration (FDA). During the session, Capricor aims to provide updates on its lead product candidate, deramiocel (CAP-1002), which is currently in Phase 3 clinical development for DMD treatment.

Deramiocel is an allogeneic cardiac-derived cell therapy that has shown immunomodulatory, antifibrotic, and regenerative properties in preclinical and clinical studies, making it a potentially significant treatment for dystrophinopathies and heart disease.

Capricor is also developing exosome-based therapeutics through its proprietary StealthX™ platform, which is still in the preclinical phase. These therapies are being explored for a range of applications, including vaccinology and targeted delivery of various therapeutic agents.

The webcast will be accessible via a conference call or through a live broadcast on the company’s website, with a replay available following the conclusion of the event.

Capricor has an exclusive agreement with Nippon Shinyaku Co., Ltd. for the commercialization and distribution of deramiocel in the United States and Japan, contingent on regulatory approval. It is important to note that deramiocel is an Investigational New Drug and has not been approved for any indications. Similarly, none of Capricor’s exosome-based candidates have received approval for clinical investigation.

This update is based on a press release statement from Capricor Therapeutics. The company continues to work towards regulatory milestones and the advancement of its therapeutic candidates.

In other recent news, Capricor Therapeutics has been making significant strides in the biopharmaceutical sector. The company has maintained its Buy rating from H.C. Wainwright and has seen its price target upgraded to $15 by Oppenheimer, following the announcement of an expanded partnership with Nippon Shinyaku. This collaboration is aimed at the commercialization and distribution of Capricor’s lead product candidate, deramiocel, in Europe, a treatment for Duchenne muscular dystrophy.

Under the terms of the agreement, Capricor is set to receive a $20 million upfront payment, with the possibility of earning up to $715 million more in development and sales milestones. Nippon Shinyaku has also committed to buying approximately $15 million worth of Capricor common stock.

Despite reporting a net loss of approximately $11 million for Q2 2024, the company generated revenue of around $4 million and maintains a strong cash position of $29.5 million. These recent developments highlight Capricor’s ongoing progress and the potential impact of its product candidate, deramiocel.

InvestingPro Insights

In the context of Capricor Therapeutics’ recent developments and the upcoming investor webcast, it is pertinent to consider the company’s financial health and market performance. According to InvestingPro data, Capricor boasts a market capitalization of $178.45 million. Despite the company’s significant revenue growth of 187.15% over the last twelve months as of Q2 2024, it’s important to note that Capricor has been grappling with negative gross profit margins (-37.73%) during the same period.

The company’s stock has experienced notable volatility, as evidenced by the 14.51% return over the past week. This could be an indicator of investor optimism surrounding the recent FDA interactions or other company-specific news. However, an InvestingPro Tip highlights that Capricor is trading at a high Price / Book multiple of 15.51, which could suggest that the stock is priced optimistically relative to its book value.

InvestingPro also provides a cautionary tip, noting that analysts do not anticipate the company will be profitable this year and have revised their earnings expectations downwards for the upcoming period. This aligns with the fact that Capricor has not been profitable over the last twelve months. Prospective investors should be aware of these dynamics as they tune into the webcast for updates on Capricor’s DMD program and regulatory progress.

For those seeking more comprehensive analysis, InvestingPro offers additional tips on Capricor, which can be accessed through the dedicated page for the company at https://www.investing.com/pro/CAPR.

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