Capricor Therapeutics Inc (NASDAQ:CAPR)

Traders Loving Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Therapeutics Inc (NASDAQ:CAPR) shares gapped up this morning and have gained over 20% from their Friday closing price on ten times their average daily volume. CAPR stock opened at $2.65, $0.38 above Friday’s close, and moved above the $3 handle within ten minutes. Sellers then came in and pushed the price down to $2.80 before the shares resumed their upward move. At the time of the writing, 10:15 AM EST, CAPR stock is trading around the $3 once again.

Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a clinical-stage biotechnology company discovers, develops, and commercializes biological therapeutics for the treatment of rare disorders. Capricor’s lead drug candidate is, CAP-1002 – an “off-the-shelf” cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor is also 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.

On November 8, 2017, Beverly Hills, CA-based Capricor Therapeutics, Inc. (NASDAQ:CAPR) reported a Q3 2017 loss of (-$2.7). or (-$0.12) per share, on adjusted revenues of $313,000. The loss beat analyst expectations that forecasted a loss of (-$0.19) per share. The biotech firm also bested expectations in Q2 when actual earnings beat estimates by 11%.

CAPR Stock Performance

At the beginning of 2012 CAPR stock was trading above $20 before it went into a steady slide. Over the past year CAPR stock has experienced a wide range in its price. Its 52-week low is $0.63 but its 52-week high is $4.25.

Shareholders of Capricor Therapeutics, Inc. (NASDAQ:CAPR) have lagged the market as the stock is down 7% year-to-date. However, in the past quarter, shares have risen over 114%. That strong gain is reflected in CAPR’s Relative Strength Index score of 68 – just below the level of 70 which many traders believe to be the threshold figure for an “oversold” condition.

Losses have plagued the company since 2012 when they posted a EPS of (-$0.21), followed by annual EPS losses of (-$0.85), (-$0.53), (-$0.81), and, for 2016, (-$1.01). Sales were on a positive slope from 2013 when it reported a figure of $500,000. By 2015 that number grew to $5.5 million, but declined in 2016 to $4 million.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $CAPR and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Capricor Therapeutics Inc. (NASDAQ:CAPR)

Capricor Therapeutics Inc. (NASDAQ:CAPR) Spikes on Trial Expectations

Capricor Therapeutics Inc. (NASDAQ:CAPR)

Capricor Therapeutics Inc. (NASDAQ:CAPR) shares gained 9.09% after the clinical stage biotechnology company said it will make a presentation at the upcoming American Heart Association Scientific Sessions 2017 conference. The company is to present data from its HOPE-1 clinical trial, investigating CAP-1002 for the treatment of Duchenne Muscular Dystrophy in boys and young men.

Capricor Therapeutics Inc. (NASDAQ:CAPR)

Hope 1 Trial

The announcement appears to have triggered renewed interest in Capricor Therapeutics. The stock has been under pressure in recent trading sessions, after rising to multi-year highs of $3.50 a share. It is currently down by more than 10% for the year.

CAP-1002 is the company’s lead investigational product made up of allogeneic cardiosphere-derived cells. Capricor Therapeutics Inc. (NASDAQ:CAPR) has already reported meaningful improvements in cardiac and skeletal muscle function, on a six-month analysis of HOPE-1 trial.

“We look forward to sharing these new data at one of the world’s premier cardiovascular conferences and continuing our clinical development of CAP-1002 for the treatment of Duchenne muscular dystrophy,” said Linda Marbán, Ph.D., Capricor president, and CEO.

Capricor Therapeutics Inc. (NASDAQ:CAPR) plans to initiate patient enrollment for a randomized double-blind placebo-controlled HOPE-2 clinical trial, subject to regulatory approval. The trial will build on HOPE-1 trials that showed teens and young men in advanced stages of DMD experiencing meaningful improvements in cardiac and limb functions after a single dose of CAP-1002.

Duchenne muscular dystrophy is a devastating genetic disorder that results in muscle degeneration. The condition affects approximately 15,000 to 20,000 boys in the US and occurs in every 3,600 live male births across all races, cultures and countries. The medical condition leads to death before the age of 30.

Q2 Financial Results

Separately, Capricor Therapeutics Inc. (NASDAQ:CAPR) reported a net loss of (-$3.5) million or (-$0.16) per share for the second quarter, compared to a net loss of (-$4.7) million reported last year. The biotechnology company generated revenues of $996,000 for the quarter.

Capricor Therapeutics Inc. (NASDAQ:CAPR) exited the quarter with cash and cash equivalent of $12.3 million, compared to $16.2 million as of December 31, 2016. According to the company, the cash balance is sufficient to fund operations and meet all the company’s financial obligations through the second quarter of 2018.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $CAPR and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Capricor Therapeutics Inc (NASDAQ:CAPR)

FDA Transcript Boosts Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Therapeutics Inc (NASDAQ:CAPR) gained almost 24% today after the biotech company released the minutes of their meeting with the U.S. Food and Drug Administration. The meeting’s subject was the development of Capricor’s intravenous drug candidate CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD).

Capricor Therapeutics Inc (NASDAQ:CAPR)
One month daily candlebar graph for Capricor Therapeutics Inc (NASDAQ:CAPR)

According to Linda Marbán, Ph.D., President and CEO of Capricor Therapeutics Inc (NASDAQ:CAPR), “The FDA’s response to our proposed clinical development plan supports our near-term objective of submitting an IND for intravenous CAP-1002 as well as provides us with clarity on a path to potential product registration. We look forward to commencing a randomized, double-blind, placebo-controlled Phase II clinical trial of intravenous, repeat-dose CAP-1002 in boys and young men with DMD in the second half of 2017, subject to regulatory approval.”

Capricor’s CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, that have been shown to exert potent immuno-modulatory activity. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to approximately 140 human subjects across several clinical trials.

Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration and weakness. The incidence of DMD is estimated to be one in every 3,600 live male births, and DMD is believed to afflict approximately 15,000 to 20,000 boys and young men in the U.S.

Shareholders of Capricor Therapeutics Inc (NASDAQ:CAPR) could use some good news. Prior to today’s trading, CAPR shares are down YTD over 60% and down over 70% for the year. The biotech firm has not posted a profit ever. In 2012 the loss was (-$0.23) per shares. That was the smallest loss in the past five years and in 2016 the loss was (-$1.01). Sales have not been a particularly bright spot either. In 2015 sales were reported at $5.5 million but last year that figure dropped to $4 million. The only two investment firms that follow Capricor Therapeutics Inc (NASDAQ:CAPR) rate the shares as a “Strong Buy”.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $CAPR and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Therapeutics Inc (NASDAQ:CAPR) Explodes After Rare FDA Designation for Duchene Muscular Dystrophy Treatment

Capricor Therapeutics Inc (NASDAQ:CAPR)

Shares of Capricor Therapeutics Inc (NASDAQ:CAPR) rallied by 98.57% in Monday’s trading session, after the company received a Rare Pediatric Disease Designation (PDD) from the U.S. Food and Drug Administration (FDA). The PDD is in relation to the company’s candidate treatment for Duchene muscular dystrophy, CAP-1002.

Stock Performance

Capricor Therapeutics Inc (NASDAQ:CAPR)
Daily $CAPR Candle Graph

The stock of Capricor Therapeutics Inc (NASDAQ:CAPR) gapped higher on Monday following the positive FDA news. The stock has underperformed the overall industry after it traded at highs of $3.43 a share a year ago.

Capricor Therapeutics Inc (NASDAQ:CAPR) is a clinical stage biotechnology company focused on the development of first class biological therapies. The company discovers, develops, and commercializes regenerative medicines for the treatment of various diseases with a focus on cardiovascular diseases.

CAP-1002 is the company’s lead product currently in clinical development. The company is also working on CAP-2003, a cell-free exosomes candidate for the treatment of various disorders.

FDA Designation

The Rare Pediatric Disease Designation as well as Orphan Drug Designation (ODD) means CAP-1002 stands to receive Rare Pediatric Disease Priority Review that should accelerate its review process. The voucher can be used to obtain a priority review for New Drug Application or Biologic Licenses Application. The voucher can be sold or transferred unlimited number of times.

CAP-1002 FDA’s designation adds to a previous Orphan Drug Designation for the treatment of Duchene Muscular Dystrophy. The designation, according to Chief Executive Officer Linda Marban, underscores the urgent need for the drug in the treatment of the rare disease.

“We believe CAP-1002 has the potential to provide meaningful clinical benefit to patients. We look forward to commencing our next clinical trial in DMD, for which design will be relevant to the overall registration plan for this candidate,” said Madam Marban.

Capricor Therapeutics Inc (NASDAQ:CAPR) announced positive results in Phase I/II Hope Clinical trial of CAP-1002 in patients struggling with DM. The company is currently in discussions with the FDA to discuss potential product registration strategies.

There are also plans to commence randomized double-blind placebo-controlled clinical trial in boys and young men struggling with Duchene. The trials could commence in the second half of the year subject to regulatory approval.

Separately, Capricor Therapeutics Inc (NASDAQ:CAPR) reported a net loss of $3.7 million for the first three months of the year. Revenues in the quarter totaled $880,000.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $CAPR and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

CytRx Corporation (NASDAQ:CYTR)

Capricor Therapeutics, Inc. (NASDAQ:CAPR) Reports Q1 Net Loss

Capricor Therapeutics, Inc. (NASDAQ:CAPR)

Capricor Therapeutics, Inc. (NASDAQ:CAPR) has announced its financial results for Q1 of 2017 and announced a number of updates on its business. Capricor president and CEO Linda Marbán, Ph.D said since the company’s announcement of positive results from the HOPE-Duchenne clinical study of CAP-1002 they are working towards meeting with the FDA to chat the way for registration as well as clinical development for the Duchenne muscular dystrophy indication.

Dr. Marbán also expressed disappointments in the recently announced results from the ALLSTAR clinical study of CAP-1002 used in treatment of heart attack. The parameters of change examined in the study did not change in addition to the inconsistency of the placebo response with the natural history of the disease.

Capricor Therapeutics, Inc. (NASDAQ:CAPR) reported positive outcome from the six-month Phase I/II HOPE-Duchenne clinical study of CAP-1002 in younger men. The company announced that a recently performed analysis showed very low probability of attaining a statistically-significant difference in the efficacy endpoint. Due to the ALLSTAR results, the company intends to cut the scope of its operations. This will entail shrinking its workforce so as to focus its efforts and resources on advancing the DMD program. The company recently reported $3.7 million in gross proceeds from a private placement of its common stock.

Capricor Therapeutics, Inc. (NASDAQ:CAPR) is currently expecting a decision on its application for CAP-1002 license from Janssen Biotech. The decision is expected to be out in the third quarter of 2017. The company is also expecting data from the Phase I/II HOPE-Duchenne clinical clinical study which is expected in the fourth quarter of 2017. Finally, the company itends to make an Investigational New Drug application (IND) for its CAP-2003 in 2018.

On the financial front, Capricor Therapeutics, Inc. (NASDAQ:CAPR) reported a net loss of around -$3.7 million or -$0.17 per share in Q1 of 2017 compared to a net loss of -$4.3 million or -$0.26 per share that was reported in Q1 of 2016. The company had $11.7 million in cash, cash equivalent and securities. This is compared to around $16.2 million that the company had in Q1 of 2016. The company believes the current financial resources which include proceeds from the recently closed private placement, will be enough to finance its activities and meet its financial requirements up to Q1 of 2017 basing on the current operations of the company.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.