Capricor Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update
-Completed Targeted Enrollment for HOPE-3, the Phase 3 Trial of CAP-1002 in Duchenne Muscular Dystrophy-
-On Track to Report Interim Futility Analysis in Fourth Quarter of 2023; Successful Outcome Would Trigger Milestone Payment to Capricor Under Commercialization and Distribution Deal with Nippon Shinyaku-
-Positive FDA Feedback on the Proposed Key Clinical and Regulatory Requirements Confirms CAP-1002’s Path Towards a Biologics License Application Submission-
-Conference Call and Webcast Today at 4:30 p.m. ET-
SAN DIEGO, Nov. 14, 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 third quarter ended September 30, 2023 and provided a corporate update.
“During our recent meeting with the U.S. Food and Drug Administration (FDA), we aligned on key features of our Phase 3 pivotal program and are pleased to have completed the targeted enrollment in this study, which marks a major milestone on our path towards potential approval of CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD),” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “While there are limited treatment options currently available for patients with DMD, we believe the potential for slowing of disease progression, robust and consistent efficacy, together with the favorable safety/tolerability profile, positions CAP-1002 as a potential anchor therapy. Further, we will continue to discuss options for expedited approval pathways with the FDA and in parallel, are well-positioned to execute on important clinical and regulatory milestones including reporting the outcome of an interim futility analysis in the fourth quarter of 2023, followed by top-line data in late 2024.”
Dr. Marbán continued, “While our major focus is on commercializing CAP-1002, we continue to progress our proprietary StealthX™ platform technology as part of our long-term strategy to leverage exosomes for therapeutic development. We continue to explore partnership opportunities and other non-dilutive sources of funding to advance this program.”
Third 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:
Third Quarter 2023 Financial Results
Cash position: The Company’s cash, cash equivalents and marketable securities totaled approximately $28.5 million as of September 30, 2023 compared to approximately $41.4 million on December 31, 2022. Subsequent to September 30, 2023, the Company completed a registered direct offering for approximately $23.0 million in gross proceeds. Additionally, in the third quarter of 2023, Capricor raised approximately $0.4 million in net proceeds through issuances of common stock at an average price of approximately $5.72 per share under its at-the-market offering program. Subsequent to September 30, 2023 and through the date of this filing, no shares were sold under the Company’s 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 third quarter of 2023 were approximately $6.2 million compared with approximately $1.6 million for the third quarter of 2022. Additionally, revenues for the nine months ended September 30, 2023 were approximately $13.1 million compared with approximately $1.6 million for the same period of 2022.
Operating expenses: Total operating expenses for the third quarter of 2023 were approximately $13.1 million compared with approximately $8.1 million for the third quarter of 2022. Total operating expenses for the nine months ended September 30, 2023 were approximately $35.9 million compared with approximately $23.2 million for the same period of 2022.
Net loss: The Company reported a net loss of approximately $6.4 million, or $0.25 per share, for the third quarter of 2023, compared to a net loss of approximately $6.4 million, or $0.26 per share, for the third quarter of 2022. The Company reported a net loss of approximately $21.5 million, or $0.85 per share, for the nine months ended September 30, 2023, compared to a net loss of approximately $21.3 million, or $0.87 per share, for the same period 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 into 2025. This expectation includes the recent registered direct offering which closed in October 2023 for approximately $23.0 million in gross proceeds and 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: 46361431. 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 June 30, 2023, as filed with the Securities and Exchange Commission on August 8, 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:
Capricor Investor Contact:
LifeSci Advisors, LLC
Capricor Company Contact:
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