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Tuesday, February 14, 2017

Some Quick Thoughts On VistaGen

On February 13, 2017, VistaGen Therapeutics (NASDAQ: VTGN) provided a business and financial update following results of the quarter ending December 31, 2016. Below is a quick review of some of the recent happenings at the company, including a look at the financial position and some near-term catalysts for the shares.

Monday, February 13, 2017

RedHill Expects BEKINDA Top-Line Data In Q2

On February 13, 2017, RedHill Biopharma Ltd. (NASDAQ: RDHL) announced that the final patient has been enrolled in the company's Phase 3 clinical study examining BEKINDA® as a treatment for acute gastroenteritis and gastritis. Top-line data from the Phase 3 study, known as the GUARD study, are expected in the second quarter 2017. A separate Phase 2 study with BEKINDA for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) is also ongoing, with top-line data expected around the middle of the year.

Below is a quick review of BEKINDA and what to expect with the upcoming Phase 3 data.

Thursday, February 9, 2017

The Case For Investment In BriaCell Therapeutics

Earlier this week, BriaCell Therapeutics Corp. (TSXV: BCT.V) announced the company is making progress towards the initiation of a Phase 1/2a clinical study with BriaVax™, a proprietary allogeneic whole tumor cell vaccine for the treatment of late-stage breast cancer. Specifically, management has submitted a Chemistry, Manufacturing, and Controls (CMC) amendment that includes the details of extensive testing performed on BriaVax. This is one of the final steps prior to U.S. FDA authorization to begin the study.

BriaCell is one of my favorite under-the-radar micro-cap immuno-oncology stories. Previous clinical data on BriaVax has been highly encouraging, including published results from a case study in which a 58-year old woman with recurrent late stage metastatic breast cancer achieved complete remission of lung lesions and near-complete remission of multiple breast lesions following treatment with an earlier version of the therapeutic vaccine (Wiseman & Kharazi, 2006).

BriaCell aims to begin the Phase 1/2a study in March 2017. Management has already appointed the lead principal investigator for the study, Dr. Jarrod P. Holmes. Dr. Holmes is a Board Certified Oncologist and a leading expert in breast cancer vaccines at Annadel Medical Group and St. Joseph Health-Sonoma County, CA. Separately, the company also announced that Cancer Insight, LLC, led by Dr. George Peoples, a surgical oncologist and leading expert in breast cancer vaccines, will serve as the contract research organization (CRO) to conduct the trial. A separate CRO, Biologics Consulting, will handle regulatory affairs.

Below is a quick update on the story, along with my investment thesis for the stock.

Wednesday, February 8, 2017

Can-Fite Phase 3 RA Program Ready To Start

Can-Fite Biopharma Ltd (NYSEMKT: CANF) is preparing to initiate a Phase 3 study with piclidenoson for the treatment of rheumatoid arthritis (RA) in the second quarter 2017. The Phase 3 study, called ACRobat, will investigate piclidenoson as a first line therapy and potential replacement for the current standard of care, methotrexate (MTX), in newly diagnosed subjects with RA. In June 2016, management met with the European Medicines Agency (EMA) to cleared the design protocol for the ACRobat trial.

MTX is the most common disease modifying anti-rheumatic drug used in patients with newly diagnosed RA that have progressed past NSAIDs or steroids. In Europe, an estimated 2.5 million individuals have RA. There are another 1.5 million estimated in the U.S. According to the Arthritis Foundation of America, 90% of these patients will take MTX at one point during their treatment. By targeting these patients, Can-Fite is going after an enormous market opportunity. Previous clinical work with piclidenoson in over 1,000 patients shows the drug to be safe and well-tolerated. Phase 2b clinical data shows superiority to MTX.

Below is a quick review of merits for piclidenoson and why this Phase 3 trial is important for investors in Can-Fite Biopharma.

Tuesday, February 7, 2017

Revive Initiates Bucillamine Phase 2 Study, Expands Focus To Include Cannabinoid Research

Earlier today, Revive Therapeutics (TSXV: RVV) announced the initiation of a Phase 2 study examining bucillamine as a treatment for cystinuria. This is an important milestone for the company, as bucillamine is the company's lead development candidate. Last month, Revive announced an expansion of the company's focus to include research and discovery of cannabinoid-based therapeutics. The company appointed Dr. Pritesh Kumar as Scientific Advisor for this effort.

Expansion into cannabinoid research is not a big stretch for Revive; the company's mission statement remains largely unchanged. Revive is still focused on advancing novel treatment options for serious and unmet medical needs, with an eye on repurposing proven safe and effective therapeutic agents for rare and orphan diseases. This is evidenced by the initiation of the Phase 2 bucillamine study noted above. However, cannabinoids also fit the model perfectly, and offer potential as both standalone and adjunct therapy treatments for many of the same unmet medical needs Revive has experience targeting through clinical and preclinical development.

Below is an on bucillamine and the Phase 2 initiation, as well as an introduction to the company's strategy in expanding the pipeline through cannabinoid research.

Monday, February 6, 2017

BioSig's Targets Enormous A-Fib Market With Game-Changing Device

BioSig Technologies, Inc. (BSGM) is a Minnesota-based medical device company developing a proprietary technology platform designed to improve the rapidly growing $4 billion dollar electrophysiology (EP) marketplace. The company’s leading product is PURE EP™, a novel surface electrocardiogram (EKG) and intracardiac multichannel recording and analysis system designed to assist electrophysiologists during catheter ablation procedures to treat cardiac arrhythmia.

Below is a "Mock Q&A" designed to help investors understand cardiac arrhythmia and atrial fibrillation, the PURE EP system and what the recently published impressive data mean, how and why PURE EP could be a game-changer for electrophysiologists, and what BioSig might be worth if management is successful at bringing PURE EP to market in the next year.

Wednesday, February 1, 2017

Narcotic Bowel Syndrome An Intriguing Opportunity For Vitality Biopharma

Vitality Biopharma, Inc. (VBIO) is developing a new class of cannabinoid prodrugs, known as cannabosides, to overcome the limitations of raw Cannabis sativa or synthetic cannabinoids. It is a strategy I believe can create significant value due to the differentiation of cannaboside products from existing cannabinoids available through prescription or over-the-counter means. The strategy also effectively distinguishes Vitality from many small biopharma companies I see developing products with little differentiation from medical or recreational marijuana.

Management is going after a very intriguing orphan drug indication called narcotic bowel syndrome (NBS) that should add intellectual property (IP) protection as well as certain important regulatory advantages for a small company like Vitality. Cannabosides also offer the added protection of being considered new chemical entities (NCE) by the U.S. FDA, which further strengthens the IP position and potential for development and commercial partnerships. IP and the lack of real commercial strategy are perhaps the two biggest drawbacks to investing in the cannabis space; Vitality Bio seems to have both these issues well covered.

Below is a quick look at the company's technology and the market opportunity in NBS.

Wednesday, January 18, 2017

Time To Go Long Brainstorm Cell Therapeutics?

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), 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.

Below is a review of Brainstorm, including a look at the science, the Phase 2 data, and the potential valuation. I think BCLI shares are looking very attractive and have established a position in the stock.