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Friday, August 26, 2016

Can-Fite Looks Meaningfully Undervalued

On August 26, 2016, Can-Fite BioPharma, Ltd (CANF) provided a financial update for the six month period ending June 30, 2016. The company also provided an update on its pipeline, which I believe remains meaningfully undervalued. Can-Fite's market capitalization today is a measly $33 million, and roughly one-third of that is cash. Below is a quick update on the key drivers at Can-Fite and why I believe the shares are attractive as we head into the back-half of the year.

Wednesday, August 24, 2016

Valeritas V-Go Targets An Enormous Market

Diabetes is a significant public health crisis. The number of American's with diabetes is soaring and will soon eclipse 30% of the population. Independent studies find that the vast majority of Type-2 diabetic patients do not achieve recommend A1C levels of less than 7% on insulin therapy. Compliance, complexity of dosing, and discretion of disease management are the key factors that lead to ineffective control for 60-80% of the Type-2 population.

Valeritas Holdings, Inc. (VLRX) has commercialized a small, wearable diabetes management device called V-Go Disposable Insulin Delivery Device ("V-Go"). V-Go is designed for patients with Type-2 diabetes who require daily insulin to achieve and maintain their target blood glucose goals. It is the first and only FDA-approved single-use, fully-disposable insulin delivery device with basal (background) and bolus (mealtime) capabilities on the market in the U.S.

V-Go is on the market and generating meaningful revenues for Valeritas. Though not yet profitable, I believe Valeritas is headed in the right direction. The company recently undertook a restructuring to streamline operations and improve profitability. With improved efficient and focused promotion, I believe Valeritas can achieve breakeven operations in the not too distant future. In the meantime, the company is reasonably valued on a revenue multiple basis and has tremendous upside as V-Go ramps over the next few years.

Thursday, August 18, 2016

Revive Makes Good On Promises, Moves Forward In Cystinuria

Last month I wrote a detailed article on Revive Therapeutics (TSX: RVV) (RVVTF) and the company's Phase 2-ready drug, bucillamine, for the treatment of cystinuria. I provide a quick review of the story below, but for investors wishing to delve deeper, my article provides an excellent starting point (LINK). However, what is important for investors to understand as of today is that Revive management has made good on some recent promises and that the story seems to be moving forward nicely.

Tuesday, August 16, 2016

RedHill Provides R&D Update, Highlights Three Phase 3 Programs and Catalyst-Rich Second Half

Last week, RedHill Biopharma Ltd. (NASDAQ: RDHL) provided an update on select R&D programs and potential milestones over the next year. The update highlights what I believe is one of the deepest and most interesting pipelines in specialty pharma. RedHill is focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases, including cancer.

The company is pursuing a multiple-shots-on-goal strategy and has three potential blockbuster drugs in Phase 3 clinical trials. The pipeline chart (shown below) shows the depth of the company's development plans. Almost all of the key assets are unpartnered, which provides the potential for investors to see substantial returns on out-licensing, M&A, or commercialization. And importantly, the company is well-capitalized, with an estimated $47.7 million in cash on hand as of June 30, 2016. Below is a quick review of the key R&D programs and why I believe that investors should take a hard look at this unique opportunity.

Monday, August 15, 2016

BrainStorm’s Valuation Doesn’t Reflect Potential Value of NurOwn® Therapy

BrainStorm Cell Therapeutics, Inc. (NASDAQ: BCLI) is biopharmaceutical company developing adult stem cell-based therapies for a variety of neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease (PD). The company’s NurOwn® technology is based on the use of mesenchymal stem cells (MSCs) that are engineered ex vivo to express increased amount of neurotrophic factors (NTFs). The company has tested single-dose treatments of NurOwn in ALS patients in two Phase 1/2 clinical trials and most recently in a randomized, double-blind, placebo-controlled Phase 2 clinical trial.

The results from these trials are very encouraging and show NurOwn has the potential to stop or slow ALS disease progression in a subset of patients. While a number of analyses have been performed on the data, what I intend to do with this article is perform a compare and contrast between BrainStorm and other companies developing treatments targeting debilitating, degenerative, and/or fatal diseases. When viewed in comparison with these companies, BrainStorm’s paltry market cap of $45 million is perplexing, and offers investors the potential for substantial returns.

Mayo Clinic Publication Highlights The Potential For BioSig's PURE-EP

In July 2016, I wrote a brief article highlighting for investors what I believe is an important relationship between Minnesota-based medical device company, BioSig Technologies, Inc. (BSGM), and researchers at Mayo Clinic. BioSig and Mayo have been collaborating since late 2014, with researchers at Mayo performing preclinical and advanced research studies with PURE EP™ since that time. For those unfamiliar with the Rochester, Minnesota-based Mayo Clinic, it was recently ranked the No. 1 hospital in the U.S. by U.S. News & World Report (1)

Mayo Clinic's R&D budget for 2016 is over $650 million, putting it on par with some of the largest publicly traded medical device companies in the world (2). The hospital has a tremendous track record of helping start-up companies achieve success, often seeing a sizable return on a take-out or IPO (3). Mayo's efforts with BioSig are headed up by Samuel Asirvatham, M.D., Professor of Medicine & Vice Chair of Division of Cardiovascular Diseases at Mayo Clinic. Dr. Asivatham is also a member of BioSig's Scientific Advisory Board (4). I believe Mayo's involvement with BioSig is central to the development of PURE EP. In fact, the title of my article last month was, "For BioSig, The Mayo Clinic Partnership Provides Confidence, Credibility" (5).

No more is that importance exemplified than through the publication of data in peer-review medical journals. As such, BioSig achieved a significant milestone with Mayo last week when Ammar M. Killu, MBBS, and fellow colleagues at Mayo Clinic including Dr. Asirvatham, published findings from a preclinical study in the Journal of the American College of Cardiology: Clinical Electrophysiology. Below I provide a quick review of that publication.

Thursday, August 11, 2016

Interview with Dr. Mark A. Smith, MD, PhD, Chief Medical Officer of VistaGen Therapeutics.

The psychiatric community seems on the verge of a medical breakthrough to treat depression, or more specifically, major depression that is resistant to traditional antidepressants like Prozac®, Paxil®, and Zoloft®. The focus is on the NMDA-receptor, and it stems from a recent discovery that ketamine, the psychiatric "party-drug" of the 70's, is both highly effective and rapidly active in reversing major depression in treatment-resistant patients.

VistaGen Therapeutics (NASDAQ: VTGN) is developing AV-101, a glycine B (GlyB) receptor antagonist that negatively modulates the N-Methyl-D-aspartic acid (NMDA) receptor and may induce synaptogenesis. It's a fundamentally different pathway from standard antidepressants like Prozac® or Lexapro®, and similar to the glutamatergic AMPA-dependent pathway of ketamine; but, without the potential negative side effects of NMDA ion channel blocking.

I wrote an article in June on VistaGen for investors (LINK) that goes over the background on NMDA, the science of AV-101, and why the drug might be a blockbuster for major depressive disorder (MDD). In July, the company appointed Dr. Mark A. Smith, M.D, Ph.D. Chief Medical Officer. Dr. Smith is a prominent research psychiatrist with more than 20 years of experience in basic research and CNS drug development from the lab bench through clinical proof of concept studies. I scheduled time with Dr. Smith for a talk about the depression market, AV-101, and where VistaGen is heading over the next few quarters.

Tuesday, August 9, 2016

HedgePath Reports Positive Interim Phase 2b Data With SUBA-Cap In Hereditary Skin Cancer

Last week, I published an article introducing investors to HedgePath Pharmaceuticals (HPPI) and the companies improved formulation of itraconazole for the treatment of Basal Cell Carcinoma Nevus Syndrome (BCCNS) / Gorlin Syndrome. Investors can view that article >> HERE

HedgePath shares are up 40% since that article came out, driven in part by the positive interim results released last week from the company's Phase 2b clinical trial with SUBA™-Itraconazole in patients with BCCNS, also known as Gorlin Syndrome. Below I provide a review of the positive Phase 2b data and compare it to Erivedge®, a leading product approved for metastatic and locally advanced basal cell carcinoma, but not for BCCNS, sold by Roche.