Biotechs Looking into the Heart of the Problem

Coronary artery disease (CAD) is the leading cause of death in the United States, with approximately 500,000 to 700,000 deaths related to CAD occurring each year.  In the United States, approximately 1.1 million cases of myocardial infarction (MI) occur annually, according to the American Heart Associations’ Heart Disease and Stroke Statistics — 2016 Update. MI is a condition where myocardial ischemia, a diminished blood supply to the heart, exceeds a critical threshold and overwhelms myocardial cellular repair mechanisms designed to maintain normal operating function and homeostasis. Ischemia at this critical threshold level for an extended period results in irreversible myocardial cell damage or death, and can result in heart failure.

Several companies are working to address this massive problem with approaches ranging from stem cells to gene therapy. One company we like just threw its hat in the mix as well.  Endonovo Therapeutics, Inc. (ENDV), a developer of non-invasive electroceuticals for the treatment of vascular diseases and inflammatory conditions, announced it is commencing a pre-clinical study to assess the therapeutic potential of its Immunotronics™ platform in the prevention of heart failure following myocardial infarction (MI). The pre-clinical study will evaluate the effect of the Company’s non-invasive electroceutical technology on cardiac function, post-MI remodeling, and infarct size, as well as angiogenesis (the development of new blood vessels). The study, estimated to be complete at the end of the first quarter of 2017, represents the first of several planned studies designed to evaluate the Company’s proprietary non-invasive medical devices in the treatment of vascular diseases and ischemia/reperfusion injury.

ENDV’s CEO, Alan collier commented, “Our technology presents a lucrative opportunity to develop a non-invasive platform device that can be used to treat cardiovascular, cerebrovascular and peripheral artery disease as well as ischemia/reperfusion injuries.”

The Company had previously announced receiving a term sheet for $5 million in preferred financing from a strategic healthcare investor to develop a therapeutic pipeline in vascular diseases, peripheral artery disease and ischemia/reperfusion injury using it non-invasive platform. The $5 million proposed financing is part of a larger $15 million round of financing to uplist the Company’s common stock onto a national stock exchange in the first half of 2017.

With several potential blockbuster indications being developed, the first of which is expected to produce results in Q1 2017, and the fact that the stock is trading at its lowest level in the past year with a history of making triple digit runs on positive news, ENDV provides a very interesting opportunity for investors looking to profit.

Here’s a couple other stocks in the industry receiving some interest.

Novartis AG (ADR) (NVS) and Conatus Pharmaceuticals Inc (CNAT) will jointly develop Conatus drug emricasan. This has resulted from the duo’s agreement under which the small U.S. company will receive $50 million upfront before further payments can follow. The partnership comes at a time when several drugmakers the likes of liver specialists such as Intercept Pharmaceuticals and Genfit are pursuing treatments for NASH. It is expected to help in the expansion of treatment options for chronic, progressive fatty liver condition, which involves inflammation and scarring. With the enormous patient population, this is likely to be a potential solution to a huge unmet need.

Akebia Therapeutics (AKBA) stock is up 24% at 2:10 p.m. EST after signing a deal with Japanese drugmaker Otsuka Pharmaceutical to develop and sell vadadustat, Akebia’s oral hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor to treat anemia associated with chronic kidney disease. So what The deal calls for Otsuka to pay $125 million upfront and $35 million in the first quarter of next year. The companies will split the cost of development, of which Otsuka has committed to pay at least $105 million. And Akebia Therapeutics has the potential to make up to $765 million more if undisclosed development and commercial milestones are met.

After releasing encouraging data from an important Phase II clinical trial, shares of Acadia Pharmaceuticals (ACAD) ran on Tuesday. This trial was designed to test its drug Nuplazid (pimavanserin) as a hopeful treatment for Alzheimer’s disease psychosis.

MannKind Corporation (MNKD) has been on fire this week. MannKind is a biopharmaceutical company that focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. On Novemebr 9th, the company and Sanofi entered into an agreement with terms for termination of their collaboration. As of September 30, 2016, MannKind recorded $2.0 million in deferred revenue. The company has recognized $161.8 million in revenue from their collaboration with Sanofi for nine months ended in September, this amount also relates to activities from prior periods previously deferred. Cash and cash equivalents at September 30, 2016 were $35.5 million, compared to $59.1 million at December 31, 2015. Shares of MannKind have fallen approximately 45.9 percent year-to-date, but have rallied roughly 18.3 26% percent in the past month

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