Full Press Release Details
Therapeutics Reports Third Quarter 2019 Financial Results and Provides Recent Corporate Update
Update on End of Phase Type-B Meeting with FDA
Data from the HOPE-2 Clinical Trial Presented at World Muscle Society
Host Conference Call and Webcast Today at 4:30 p.m. ET
November 7, 2019 - 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 (DMD) and other rare disorders,
today announced its financial results for the third quarter 2019 and provided a recent corporate update.
Company's development and achievements in the third quarter have been encouraging on multiple levels and we will be providing
updates on trial advancement, evidence development, KOL support, regulatory developments and increased financial discipline across
the firm" said Linda Marb n, Ph.D., Capricor President and Chief Executive Officer.
The 24th International
Congress of the World Muscle Society provided an exciting venue for the Company's "late breaking" presentation
unveiling our interim results in the Phase II HOPE-2 clinical trial of CAP-1002. This brought a significant amount of international
attention to Capricor at the conference. This new data also opens the possibility for potential collaborations with other companies
passionate about aiding patients with DMD.
with the FDA was recently held where data from the interim analysis of the HOPE-2 trial was presented. As the company disclosed
previously, Capricor has been granted RMAT and Orphan Drug Designation by the FDA for CAP-1002 for the treatment
of Duchenne muscular dystrophy.
the later stage DMD patients, which the HOPE-2 trial is focused on, we hope that our therapeutic may one day be an important treatment
option. Capricor has been able to demonstrate meaningful benefit to non-ambulant patients where there are limited options in treating
DMD. We are eager to enrich the lives of patients and their families who suffer from DMD due to limitations in the current treatment
paradigm." Dr. Marb n said.
Quarter Highlights and Recent Clinical and Operational Developments
Evidence Development
Opinion Leader Support
Alignment and Financial Discipline
Events and Upcoming Targeted Milestones
Quarter Financial Results
reported a net loss of approximately $1.6 million, or $0.43 per share, for the third quarter of 2019, compared to a net loss of
approximately $4.1 million, or $1.35 per share, for the third quarter of 2018.
30, 2019, the Company's cash, cash equivalents and marketable securities totaled approximately $6.8 million compared to
approximately $7.3 million on December 31, 2018. Additionally, so far in the third quarter of 2019, Capricor has raised approximately
$2.6 million in net proceeds at an average price of approximately $3.81 per share under its at-the-market offering programs.
believes that its current financial resources should be sufficient to fund its operations and meet its financial obligations through
at least the second quarter of 2020 based on the Company's current projections.
Conference Call and Webcast
in the conference call, please dial 866-717-4562 (domestic) or 210-874-7812 (international) and reference the access code: 9775366.
via a webcast, please visit: https://edge.media-server.com/mmc/p/4uhn24bi. The webcast will be archived for approximately
30 days and will be available at http://capricor.com/news/events/.
Duchenne Muscular Dystrophy
muscular dystrophy is a devastating genetic disorder that causes muscle degeneration and leads to death, generally before the
age of 30, most commonly from heart failure. It occurs in one in every 3,600 live male births across all races, cultures and countries.
Duchenne muscular dystrophy afflicts approximately 200,000 boys and young men around the world. Treatment options are limited,
and there is no cure.
consists of allogeneic cardiosphere-derived cells, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical
and clinical studies to exert potent immunomodulatory activity, and is being investigated for its potential to modify the immune
system's activity to encourage cellular regeneration. CDCs have been the subject of over 100 peer-reviewed scientific publications
and have been administered to over 150 human subjects across several clinical trials.
About Capricor Therapeutics
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 DMD. Capricor is also exploring the potential
of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information, visit www.capricor.com.
Keep up with Capricor on social
Cautionary Note Regarding
Forward-Looking 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, 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, 2018 as filed with the Securities and Exchange
Commission on March 29, 2019, and as amended by its Amendment No. 1 to Annual Report on Form 10-K/A filed with the Securities
and Exchange Commission on April 1, 2019, in its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, as
filed with the Securities and Exchange Commission on August 8, 2019, and in its Registration Statement on Form S-3 as filed with
the Securities and Exchange Commission on October 24, 2018, and as amended by its Amendment No. 1 to Form S-3 filed with the Securities
and Exchange Commission on July 17, 2019, together with prospectus supplements thereto. 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.
is an Investigational New Drug and is not approved for any indications. CAP-2003 has not yet been approved for clinical investigation.
For more information, please
Investors & Media Relations
LifeSci Advisors, LLC
Chief Financial Officer
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| REVENUE | ||||||||||||||||
| Revenue | $ | 142,071 | $ | 219,249 | $ | 782,928 | $ | 1,023,274 | ||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | 857,764 | 3,131,999 | 4,313,056 | 9,217,423 | ||||||||||||
| General and administrative | 911,968 | 1,259,180 | 2,720,391 | 3,826,972 | ||||||||||||
| TOTAL OPERATING EXPENSES | 1,769,732 | 4,391,179 | 7,033,447 | 13,044,395 | ||||||||||||
| LOSS FROM OPERATIONS | (1,627,661 | ) | (4,171,930 | ) | (6,250,519 | ) | (12,021,121 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Investment income | 21,061 | 35,792 | 80,840 | 89,905 | ||||||||||||
| Loss on disposal of fixed asset | - | - | (2,720 | ) | - | |||||||||||
| NET LOSS | (1,606,600 | ) | (4,136,138 | ) | (6,172,399 | ) | (11,931,216 | ) | ||||||||
| OTHER COMPREHENSIVE INCOME (LOSS) | ||||||||||||||||
| Net unrealized gain (loss) on marketable securities | - | 1,922 | (12,393 | ) | 8,587 | |||||||||||
| COMPREHENSIVE LOSS | $ | (1,606,600 | ) | $ | (4,134,216 | ) | $ | (6,184,792 | ) | $ | (11,922,629 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.43 | ) | $ | (1.35 | ) | $ | (1.76 | ) | $ | (4.13 | ) | ||||
| Weighted average number of shares, basic and diluted | 3,746,801 | 3,060,988 | 3,500,002 | 2,886,255 |
| September 30, 2019 (unaudited) | December 31, 2018 | |||||||
| Cash, cash equivalents and marketable securities | $ | 6,827,570 | $ | 7,256,416 | ||||
| Total assets | $ | 7,907,415 | $ | 9,247,065 | ||||
| Total liabilities | $ | 4,336,981 | $ | 4,631,478 | ||||
| Total stockholders' equity - 4,174,856 and 3,138,748 common shares issued and | ||||||||
| outstanding at September 30, 2019 and December 31, 2018, respectively | 3,570,434 | 4,615,587 | ||||||
| Total liabilities and stockholders' equity | $ | 7,907,415 | $ | 9,247,065 |