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LOS ANGELES, Aug. 09, 2018 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment of Duchenne muscular dystrophy and other rare disorders, today announced its financial results for the second quarter, which ended June 30, 2018, and provided a corporate update.
“Capricor continues to move forward with the clinical development of CAP-1002, our lead cell therapy product, to treat Duchenne muscular dystrophy,” said Linda Marbán, Ph.D., Capricor president and chief executive officer. “We are actively enrolling patients in HOPE-2, with multiple sites initiated, and we anticipate having all sites up and running during the third quarter of this year. We are thrilled to begin enrolling participants in HOPE-2 because we have seen the potential for improvements in muscle function in both pre-clinical studies and in our earlier HOPE-Duchenne trial.”
“These designations will enable us to work closely with the FDA in finalizing the regulatory approval pathway for CAP-1002 and to receive expedited FDA reviews,” Dr. Marbán said. “We are hopeful that HOPE-2 may potentially be a registration trial.”
Capricor has also recently announced that the development of CAP-2003, the company’s other investigational therapy, is moving forward with a collaboration with the U.S. Army Institute of Surgical Research (USAISR) to explore the potential for the exosome-based candidate to address traumatic injuries and conditions.
“This exciting new collaboration with USAISR has the potential to open up a whole new arena in biotechnology, where the benefits of cells can be distilled down to the active pharmaceutical ingredient (API), which we now know is extracellular vesicles,” said Dr. Marbán. “If this collaboration proves to be promising, it will result in us working to develop large-scale manufacturing and clinical development of CAP-2003.”
Second Quarter Highlights and Recent Clinical and Operational Developments
Anticipated Events and Milestones in Second Half of 2018
Second Quarter Results
The Company reported a net loss of approximately $4.1 million, or $0.14 per share, for the second quarter of 2018, compared to a net loss of approximately $3.5 million, or $0.16 per share, for the second quarter of 2017.
As of June 30, 2018, the Company's cash, cash equivalents and marketable securities totaled approximately $12.3 million, compared to approximately $14.1 million on December 31, 2017. Additionally, in the second quarter of 2018, Capricor raised approximately $2.8 million in net proceeds at an average price of approximately $1.43 per share under its at-the-market offering program. Capricor believes that its current financial resources should be sufficient to fund its operations and meet its financial obligations into the second quarter of 2019 based on the Company's current projections.
Conference Call and Webcast
To participate in the conference call, please dial 866-717-4562 (domestic) or 210-874-7812 (international) and reference the access code 8483546.
To participate via a webcast, please visit https://edge.media-server.com/m6/p/ch8cwhpt. The webcast will be archived for approximately 30 days and will be available at http://capricor.com/news/events/.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class biological therapeutics for the treatment of rare disorders. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor has also established itself as one of the leading companies investigating the field of extracellular vesicles and is exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. The HOPE-Duchenne trial was funded in part by the California Institute for Regenerative Medicine. For more information, visit www.capricor.com.
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; 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, expectations with respect to the expected use of proceeds from Capricor’s stock 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, 2017 as filed with the Securities and Exchange Commission on March 22, 2018, in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, together with the prospectus included therein and prospectus supplements thereto and in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as filed with the Securities and Exchange Commission on May 14, 2018. 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. CAP-2003 has not yet been approved for clinical investigation.
CAPRICOR THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|Three months ended June 30,||Six months ended June 30,|
|Research and development||3,388,908||3,128,182||6,085,424||6,385,331|
|General and administrative||1,178,060||1,246,942||2,567,792||2,436,181|
|TOTAL OPERATING EXPENSES||4,566,968||4,375,124||8,653,216||8,821,512|
|LOSS FROM OPERATIONS||(4,163,008||)||(3,378,662||)||(7,849,191||)||(6,944,243||)|
|OTHER INCOME (EXPENSE)|
|TOTAL OTHER INCOME (EXPENSE)||39,460||(93,475||)||54,113||(194,513||)|
|OTHER COMPREHENSIVE INCOME (LOSS)|
|Net unrealized gain (loss) on marketable securities||(2,044||)||(2,394||)||6,665||3,793|
|Net loss per share, basic and diluted||$||(0.14||)||$||(0.16||)||$||(0.28||)||$||(0.33||)|
|Weighted average number of shares, basic and diluted||29,031,888||22,135,198||27,974,484||21,769,142|
CAPRICOR THERAPEUTICS, INC.
SUMMARY BALANCE SHEETS
|June 30, 2018 (unaudited)||December 31, 2017|
|Cash, cash equivalents and marketable securities||$||12,334,228||$||14,124,935|
|Total stockholders' equity - 29,994,316 and 26,270,491 common shares issued and
outstanding at June 30, 2018 and December 31, 2017, respectively
|Total liabilities and stockholders' equity||$||14,327,071||$||16,273,789|
For more information, please contact: AJ Bergmann, Chief Financial Officer +1-310-358-3200 firstname.lastname@example.org