Shares of Capricor Therapeutics (CAPR) gained 8.4% on Thursday following the completion of the submission of a biologics license application (BLA) to the FDA seeking full approval for deramiocel to treat patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. CAPR’s lead product candidate and only clinical pipeline asset, deramiocel, is an investigational, allogeneic cardiac-derived cell therapy. A final decision of the FDA is anticipated in the second half of 2024.Capricor initiated its r ...

-If approved, deramiocel would be first approved therapy for Duchenne muscular dystrophy cardiomyopathy- -BLA submission triggers $10 million milestone payment to Capricor from Nippon Shinyaku- SAN DIEGO, Jan. 02, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of the submission of its Biologics License Application (BLA) to the U.S. Food and ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended September 30, 2024 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to Commission File Number: 001-34058 CAPRICOR THERAPEUTICS, INC. (Exact Name Of Registrant As Specified In Its Charter) Delaware 88-0363465 (State ...

Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q3 2024 Earnings Conference Call November 13, 2024 4:30 PM ET Company Participants A.J. Bergmann - Chief Financial Officer Linda Marbán - Chief Executive Officer Conference Call Participants Ted Tenthoff - Piper Sandler Leland Gershell - Oppenheimer Rick Miller - Cantor Fitzgerald Aydin Huseynov - Ladenburg Operator Good afternoon, ladies and gentlemen and welcome to the Capricor's Third Quarter 2024 Financial Results and Corporate Update Call. At this time, all par ...

Capricor Therapeutics (CAPR) came out with a quarterly loss of $0.38 per share versus the Zacks Consensus Estimate of a loss of $0.34. This compares to loss of $0.25 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -11.76%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.32 per share when it actually produced a loss of $0.35, delivering a surprise of -9.38%.Over the last four quarters, the ...

Deramiocel Development and Commercialization - Capricor initiated a rolling BLA submission for deramiocel in October 2024, with full submission expected by year-end 2024, targeting a potential PDUFA date in the second half of 2025[1][4] - Capricor signed a binding term sheet with Nippon Shinyaku for European expansion and commercialization of deramiocel, with potential milestones totaling approximately $1.5 billion[1][5] - Capricor plans to provide clinical data on skeletal muscle myopathy from the Phase 3 HOPE-3 trial to support potential label expansion for deramiocel[4] Financial Performance and Position - Capricor reported Q3 2024 revenues of approximately $2.3 million, down from $6.2 million in Q3 2023, primarily from ratable recognition of $40 million upfront and milestone payments from Nippon Shinyaku[9] - Revenue for Q3 2024 was $2.26 million, a decrease from $6.19 million in Q3 2023[18] - Total revenue for the nine months ended September 30, 2024, was $11.14 million, down from $13.09 million in the same period in 2023[18] - Capricor's Q3 2024 net loss was approximately $12.6 million, or $0.38 per share, compared to a net loss of $6.4 million, or $0.25 per share, in Q3 2023[11] - Net loss for Q3 2024 was $12.56 million, compared to $6.39 million in Q3 2023[18] - Comprehensive loss for Q3 2024 was $12.62 million, compared to $6.46 million in Q3 2023[18] - Capricor's cash position as of September 30, 2024, was approximately $85.0 million, up from $39.5 million at the end of 2023, supported by recent equity offerings[8] - Cash, cash equivalents, and marketable securities increased to $85.03 million as of September 30, 2024, from $39.49 million as of December 31, 2023[18] - Total assets grew to $92.95 million as of September 30, 2024, from $58.73 million as of December 31, 2023[18] - Total liabilities decreased to $24.69 million as of September 30, 2024, from $36.13 million as of December 31, 2023[18] - Total stockholders' equity increased to $68.26 million as of September 30, 2024, from $22.60 million as of December 31, 2023[18] Clinical Trial Results and Data - Capricor presented positive 3-year safety and efficacy results from the HOPE-2 OLE trial, showing improvements in cardiac function and a statistically significant benefit in PUL v2.0 total score[5] StealthX™ Exosome Platform and Project NextGen - Capricor's StealthX™ exosome platform was selected for Project NextGen, with manufacturing underway and delivery to NIAID planned for Q1 2025, with preliminary data expected in Q2 2025[7] Capital Raising and Cash Runway - Capricor completed a public offering of common stock, raising gross proceeds of approximately $86 million, extending its cash runway into 2027[1][8] Manufacturing and Production Expansion - Capricor is exploring GMP production expansion to meet potential product demand in the U.S. and other regions[4]

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The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Is Capricor Therapeutics (CAPR) one of those stocks right now? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Capricor Therapeutics is a member of our Medical group, which includes 1024 different companies and currently sits at #3 in the Zacks Sector Rank. The Zacks Sector Rank gaug ...

Capricor Therapeutics (CAPR) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, th ...

SAN DIEGO, Oct. 18, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today the closing of its previously announced underwritten public offering of 5,073,800 shares of its common stock, including the exercise in full of the underwriters' option to purchase additional shares to cover over allotments, bringing the total gross proceeds to Capricor from the offering to ...