Capricor Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update -Presented Statistically Significant 24-Month HOPE-2 Open Label Extension Data at the PPMD Annual Conference- -Enrollment

Capricor Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

-Presented Statistically Significant 24-Month HOPE-2 Open Label Extension Data at the PPMD Annual Conference-

-Enrollment Continues to Progress in HOPE-3, the Phase 3 Trial of CAP-1002 in Duchenne Muscular Dystrophy; On Track to Complete Enrollment and Report Interim Analysis in Fourth Quarter of 2023-

-Held Type-B Clinical Meeting with the FDA to Discuss CAP-1002's Pathway Towards Potential Biologics License Application Submission-

-Conference Call and Webcast Today at 4:30 p.m. ET-

SAN DIEGO, Calif., August 7, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today its financial results for the second quarter ended June 30, 2023 and provided a corporate update.

"In the second quarter of 2023 we presented positive two-year data from our ongoing HOPE-2 open label extension (OLE) study, which we believe further supports our rapidly advancing late-stage clinical development program for CAP-1002 in patients with Duchenne Muscular Dystrophy (DMD)," said Linda Marb n, Ph.D., Capricor's chief executive officer. "The robust and consistent results seen after two years of treatment with CAP-1002 are tremendously impactful for DMD patients, showing evidence of skeletal and cardiac functional improvements, which underscores the potential long-term benefit of CAP-1002 treatment. We recently held a clinical meeting with the U.S. Food and Drug Administration (FDA) to discuss these results, together with key features of our ongoing Phase 3 HOPE-3 trial. The objective was to outline the proposed path towards submission of a potential Biologics License Application (BLA) in the most expeditious way possible, and we look forward to sharing the outcome of this meeting once we receive final meeting minutes from the FDA. Additionally, with progress of HOPE-3 accelerating, we expect to complete enrollment and report the outcome from the interim analysis in the fourth quarter of 2023."

Dr. Marb n continued, "Further, as we remain committed to driving shareholder value as well as maximizing the value of CAP-1002, we continue to explore opportunities for additional partnerships for DMD as well as new potential indications for which CAP-1002 can provide benefits to patients in need. We look forward to building on the strength of the Company with the additions of Drs. Gotwals and Auwaerter to Capricor's Board of Directors and we are entering the second half of the year in a strong position. Their deep industry experience and forward-looking vision will be invaluable as we continue to deliver on important clinical and regulatory milestones for CAP-1002 and as we continue efforts to advance our exosome platform technology, StealthX ."

Second Quarter 2023 and Recent Operational Developments

CAP-1002 Duchenne Muscular Dystrophy Program

Exosome Platform Technology

Anticipated Milestones and Events

The Company has set forth the following guidance for pipeline progression:

Second Quarter 2023 Financial Results

Cash position: The Company's cash, cash equivalents and marketable securities totaled approximately $37.8 million as of June 30, 2023 compared to approximately $41.4 million on December 31, 2022. Additionally, in the second quarter of 2023, Capricor raised approximately $2.1 million in net proceeds through issuances of common stock at an average price of approximately $4.87 per share under its at-the-market offering program.

Revenues: Capricor's primary source of revenue was from the ratable recognition of the $30.0 million upfront payment in accordance with its U.S. Exclusive Commercialization and Distribution Agreement received from Nippon Shinyaku in the first quarter of 2022. Revenues for the second quarter of 2023 were approximately $3.9 million compared with zero for the second quarter of 2022. Additionally, revenues for the first half of 2023 were approximately $6.9 million compared with zero for the first half of 2022.

Operating expenses: Total operating expenses for the second quarter of 2023 were approximately $11.7 million compared with approximately $7.3 million for the second quarter of 2022. Total operating expenses for the first half of 2023 were approximately $22.8 million compared with approximately $15.2 million for the first half of 2022.

Net loss: The Company reported a net loss of approximately $7.4 million, or $0.29 per share, for the second quarter of 2023, compared to a net loss of approximately $7.1 million, or $0.29 per share, for the second quarter of 2022. The Company reported a net loss of approximately $15.1 million, or $0.60 per share, for the first half of 2023, compared to a net loss of approximately $14.9 million, or $0.61 per share, for the first half of 2022.

Capricor believes that based on the current operating plan and financial resources, its available cash, cash equivalents and marketable securities will be sufficient to cover anticipated expenses and capital requirements through the third quarter of 2024. This expectation excludes any additional potential milestone payments under its exclusive commercialization and distribution agreements with Nippon Shinyaku as well as any strategic use of capital not currently in the Company's base-case planning assumptions.

Conference Call and Webcast

To participate in the conference call, please dial 888-886-7786 (Domestic/Toll-Free) or 416-764-8658 (International) and reference the conference ID: 02236204. To participate via a webcast, please click here. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company's website.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases. Capricor's lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy that is currently in late-stage clinical development for

treating Duchenne muscular dystrophy. Further, Capricor has entered into a partnership for the exclusive commercialization and distribution of CAP-1002 for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Capricor is also developing its exosome technology as a next-generation therapeutic platform. Our proprietary StealthX exosome platform has potential for a broad range of new therapeutic applications in the field of vaccinology as well as targeted oligonucleotide, protein and small molecule therapeutics to treat or prevent a variety of diseases. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and Twitter.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; the ability to achieve product milestones and to receive milestone payments from commercial partners; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams and revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission on March 17, 2023 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, as filed with the Securities and Exchange Commission on May 12, 2023. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor's exosome-based candidates have been approved for clinical investigation.

For more information, please contact:

Capricor Media Contact:

KCSA Strategic Communications

Capricor Investor Contact:

LifeSci Advisors, LLC

Capricor Company Contact:

AJ Bergmann, Chief Financial Officer

CAPRICOR THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

CAPRICOR THERAPEUTICS, INC.

SUMMARY BALANCE SHEETS