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 “off-the-shelf” cardiac cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy.
The company recently announced that the American Heart Association (AHA) Scientific Sessions 2017 has accepted for presentation at a late-breaking session the 12-month results from the company’s HOPE-1 clinical trial of its lead investigational product, CAP-1002, in boys and young men in advanced stages of Duchenne muscular dystrophy.
Capricor previously reported that meaningful improvements in cardiac and skeletal muscle function were observed at a pre-specified six-month analysis of the HOPE-1 Trial. CAP-1002 is the company’s lead investigational product and consists of allogeneic cardiosphere-derived cells, which improved muscle function and increased new muscle cell generation in preclinical models of Duchenne muscular dystrophy.
CAPR has Plan to Initiate HOPE-2 Clinical Trial of CAP-1002 in 1Q18
- Randomized, double-blind, placebo-controlled
- Peripheral intravenous delivery – supported by preclinical studies
- Repeat-dose design – potential to achieve sustained benefit
- Primary efficacy endpoint to be based on the PUL test at six months
- FDA willing to accept PUL as an efficacy endpoint for registration
- Type B meeting held following six-month HOPE data
This is an inflection point for Capricor, as it is about to move into a phase II trial for the CAP-1002 as mentioned above. We expect that action will continue to drive Capricor higher during the upcoming periods as the pivotal trial initiates and as markets factors in a successful outcome. Several equities research analysts recently issued favorable reports on CAPR shares. On average, the consensus target is $8.30 over the medium term.
About the company: 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 “off-the-shelf” 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, treating a variety of disorders.
CAP – 1002: Capricor’s lead candidate, CAP-1002, is a cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy (DMD). CAP-1002 is an allogeneic product, meaning that it is manufactured from donor heart tissue and then stored until needed for use.
Key unique factors:
- Pipeline focused on rare pediatric disorders for which current options are inadequate
- Clinical proof-of-concept demonstrated in lead indication
- Potential registration trial planned to initiate in 1Q18
- $1B+ U.S. sales opportunity
- Capricor holds worldwide IP rights
- Scalable, cost-efficient manufacturing process in development
- Disruptive technology platform that may address several challenging diseases
Recent and Upcoming Milestones
CAP-1002 in Duchenne Muscular Dystrophy
- April 2017: Reported positive top-line six-month results of HOPE trial
- July 2017: Granted Rare Paediatric Disease Designation
- July 2017: Announced results of FDA meeting
- September 2017: Announced Craig McDonald, M.D. to lead HOPE-2 clinical trial
- October 2017: Present six-month HOPE results at World Muscle Society Congress
- 4Q 2017: Submit IND for i.v. CAP-1002 in DMD with request for RMAT Designation
- 1Q 2018: Plan to initiate HOPE-2 Trial of repeat-dose, intravenous CAP-1002*
- Expect to submit IND for hypoplastic left heart syndrome (HLHS)
2nd Quarter 2017 Financial Results:
- The Company reported a net loss of approximately $3.5 million, or $0.16 per share, for the second quarter of 2017, compared to a net loss of roughly $4.7 million, or $0.26 per share, for the second quarter of 2016.
- As of June 30, 2017, the Company’s cash, cash equivalents, and marketable securities totaled approximately $12.3 million compared to roughly $16.2 million on December 31, 2016. Capricor believes that its current financial resources should be sufficient to fund its operations and meet its financial obligations through the second quarter of 2018 based on the Company’s current projections.
- Upcoming Results: CAPR will release their next quarterly earnings announcement on Wednesday, November 8th, 2017.
Key risk factors and potential stock drivers:
- There is the potential upside catalyst for the company and, if news hits press favorably, the stock of the company will be on a growth trajectory. Even if it misses, the subsequent dip in share price will serve as an option to make a position for the eventual upside run.
- Notwithstanding promising data and partnerships, ONCS does not have a product yet approved by FDA. There is a risk that their potential drugs might fail during the clinical trials.
- Given the current burn rate, the company would need incremental working capital. Therefore, we might see a near-term raise and subsequent dilution.
- The company may experience financial, regulatory, or operational difficulties, which may impair its ability to commercialize their drug products.
On Monday, November 6th, 2017, CAPR is trading at $2.18/share, with an above average volume of 2.32 million shares exchanging hands. Market capitalization is $56.66 million. The current RSI is 45.70
In the past 52 weeks, shares of CAPR have traded as low as $0.63 and as high as $4.25
At $2.18, shares of CAPR are trading above its 50-day moving average (MA) at $2.04 and above its 200-day MA at $1.97 as well.
The present support and resistance levels for the stock are at $2.14 & $2.34 respectively.
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