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 March 31, 2025 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) (State or other jurisdiction of ...

Core Viewpoint - Capricor Therapeutics is conducting its Q1 2025 earnings conference call, indicating ongoing engagement with investors and stakeholders regarding its financial performance and future plans [1]. Group 1: Company Overview - The conference call features key participants including the Chief Financial Officer A.J. Bergmann and Chief Executive Officer Linda Marban, highlighting the leadership's involvement in communicating with investors [1]. - The call is structured to include a presentation followed by a question-and-answer session, suggesting a transparent approach to investor relations [1]. Group 2: Forward-Looking Statements - The CFO, A.J. Bergmann, emphasizes that forward-looking statements will be made regarding various aspects such as product efficacy, safety, R&D plans, clinical study timelines, and regulatory developments [3]. - These statements are based on current information and assumptions, which are subject to change due to risks and uncertainties that could lead to actual results differing from projections [4].

Capricor Therapeutics (CAPR) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Speaker0 This call is being recorded on Tuesday, May thirteenth of twenty twenty five. I would now like to turn the conference over to our CFO, AJ Bergmann, for the forward looking statement. Please go ahead. Speaker1 Thank you, and good afternoon, everyone. Before we start, I would like to state that we will be making certain forward looking statements during today's presentation. These statements may include statements regarding, ...

"We continue to make strong progress in 2025 as we advance toward our goal of delivering the first approved therapy for Duchenne cardiomyopathy—a condition with no approved treatments," said Linda Marbán, Ph.D., Capricor's Chief Executive Officer. "We continue to have active dialogue with the FDA as they review our BLA and we remain on track with our PDUFA target action date of August 31, 2025. Preparations are progressing for our upcoming FDA advisory committee meeting, pre-approval inspection, and potenti ...

Biologics License Application (BLA) for deramiocel in the treatment of Duchenne muscular dystrophy (DMD) remains under priority review by the U.S. FDA, with a target Prescription Drug User Fee Act (PDUFA) date slated for August 31, 2025Recently completed mid-cycle review meeting with FDA with no significant deficiencies identified; late cycle meeting scheduled for June FDA has indicated intent to convene advisory committee meetingAppointed Dr. Michael Binks as Chief Medical Officer, bringing deep experience ...

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving Capricor Therapeutics, Inc. and its officers or directors [1] Group 1: Company Developments - On May 5, 2025, Capricor announced that the FDA confirmed its intent to hold an advisory committee meeting regarding the Biologics License Application for deramiocel, a treatment for Duchenne muscular dystrophy cardiomyopathy [2] - Following this announcement, Capricor's stock price dropped by $3.00 per share, representing a 29.13% decline, closing at $7.30 per share on May 6, 2025 [3] Group 2: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a history of recovering significant damages for victims of securities fraud and corporate misconduct [4]

NEW YORK, May 09, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Capricor and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On ...

Company to Host Conference Call, May 13, 2025 at 4:30 p.m. ETSAN DIEGO, May 06, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, will release its financial results for the first quarter ended March 31, 2025, after the market close on Tuesday, May 13, 2025. Management will then host a webcast and conference call at 4:30 p.m. ET on May 13. Title:Capricor Therapeutics First Qu ...

Core Insights - Capricor Therapeutics is set to present at the 2025 Piper Sandler Virtual Cardio Day on April 2, 2025, focusing on its lead program, deramiocel, for Duchenne muscular dystrophy (DMD) [1][2] Company Overview - Capricor Therapeutics is a biotechnology company specializing in cell and exosome-based therapeutics aimed at treating rare diseases, with deramiocel being its lead product candidate [4] - Deramiocel is an allogeneic cardiac-derived cell therapy that has demonstrated significant immunomodulatory and anti-fibrotic effects in preserving cardiac and skeletal muscle function in conditions like DMD [4] - The company is also developing its proprietary StealthX™ platform for exosome technology, targeting various therapeutic areas including vaccinology and targeted delivery of therapeutics [4] Recent Developments - Capricor has entered into an exclusive commercialization and distribution agreement for deramiocel in the United States and Japan with Nippon Shinyaku Co., Ltd. [6] - The presentation at the Piper Sandler event will include discussions on regulatory, scientific, and corporate updates related to deramiocel [2][3]

Financial Performance - The company reported net losses of $40.5 million and $22.3 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $199.8 million as of December 31, 2024 [467]. - Cash flow used in operating activities was approximately $40.0 million for 2024, compared to $25.6 million for 2023, indicating a significant increase in cash outflow [491]. - The net loss for the year ended December 31, 2024, was approximately $40.5 million, driven by increased R&D expenses [490]. - Clinical development income for the years ended December 31, 2024 and 2023 was approximately $22.3 million and $25.2 million, respectively, reflecting a decrease of 11.5% [474]. - Total research and development expenses increased by approximately $13.5 million, or 37%, from $36.4 million in 2023 to $50.0 million in 2024 [476][477]. - General and administrative expenses rose by approximately $2.1 million, or 16%, from $12.8 million in 2023 to $14.9 million in 2024 [478]. Cash and Securities - As of December 31, 2024, Capricor had cash, cash equivalents, and marketable securities totaling approximately $151.5 million [466]. - Cash and cash equivalents decreased from $14.7 million in 2023 to $11.3 million in 2024, while marketable securities increased significantly from $24.8 million to $140.2 million [488]. - Total cash, cash equivalents, and marketable securities as of December 31, 2024, were approximately $151.5 million, a significant increase from $39.5 million in 2023 [490]. - The fair value of the company's cash, cash equivalents, and marketable securities was approximately $151.5 million as of December 31, 2024 [538]. Clinical Trials and Development - The ongoing Phase 3 HOPE-3 clinical trial has enrolled approximately 105 eligible study subjects, with a positive outcome of the futility analysis for Cohort A [462]. - The HOPE-2 trial met its primary efficacy endpoint with a p-value of 0.01 for the mid-level dimension of the Performance of the Upper Limb (PUL) v1.2 [460]. - Capricor plans to provide clinical data on skeletal muscle myopathy to support potential label expansion for DMD treatment [463]. - Capricor received a CIRM grant of approximately $3.4 million for the HOPE-Duchenne clinical trial, with a co-funding requirement of approximately $2.3 million [508]. Funding and Revenue Recognition - Capricor received an upfront payment of $30.0 million in 2022 under the U.S. Distribution Agreement for deramiocel [497]. - The first milestone payment of $10.0 million was received upon completion of the futility analysis of the HOPE-3 trial, with a second milestone payment of $10.0 million due upon BLA submission to the FDA in December 2024 [497]. - Potential sales-based milestones could reach up to $605.0 million based on annual net sales of deramiocel, with Capricor entitled to 30-50% of product revenue [497]. - An upfront payment of $12.0 million was received in Q1 2023 under the Japan Distribution Agreement, with additional milestone payments of up to approximately $89.0 million possible [499]. - Capricor entered into a Binding Term Sheet with Nippon Shinyaku for the European region, with a potential upfront payment of $20.0 million and additional milestone payments of up to $715.0 million [501]. - The company evaluates the probability of significant reversals in cumulative revenue recognized for milestones and shared revenue payments at the end of each reporting period [521]. - The company recognizes grant income in the period in which the expense is incurred for reimbursable expenses under the terms of the grant [525]. - The company uses the proportional performance method or straight-line basis for revenue recognition when performance obligations are satisfied over time [523]. Future Expenses and Investments - The company anticipates significant increases in expenses and operating losses as it continues to develop deramiocel and other product candidates [469]. - The company expects to spend approximately $40.0 million to $50.0 million in 2025 for the deramiocel program, primarily for CMC expansion and pre-commercial expenses [484]. - The company anticipates spending approximately $5.0 million to $7.5 million in 2025 on development expenses related to its exosome platform [485]. - The company expects to record additional non-cash compensation expense in the future related to stock-based compensation [532]. - The company aims to mitigate default risk by investing in high credit quality securities and does not hedge interest rate exposure [539]. Stock and Share Transactions - In 2024, Capricor sold 6,252,229 shares of common stock at an average price of approximately $9.34 per share, resulting in gross proceeds of $58.4 million [468]. - On October 16, 2024, Capricor completed a public offering of 5,073,800 shares at $17.00 per share, raising approximately $86.3 million before expenses [502]. - A private placement on September 16, 2024, resulted in the sale of 2,798,507 shares at $5.36 per share for approximately $15.0 million [503]. - The ATM Program raised approximately $75.0 million from the sale of 9,228,383 shares at an average price of $8.13 per share, which was closed on October 1, 2024 [507]. Exosome Platform Development - The company is developing a precision-engineered exosome platform technology for therapeutic applications, including a vaccine for COVID-19 [465]. - The company performs assessments to determine if a significant financing component exists in its distribution agreements, typically finding that it does not [522]. - Research and development expenses primarily consist of salaries, clinical trial costs, and other related expenses, which are expensed as incurred [526]. - The company is currently evaluating the impact of ASU No. 2024-03 on its financial statement disclosures, effective after December 15, 2026 [536].