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Wednesday, May 25, 2016

Interview with InVivo Therapeutics Chairman & CEO - Mark Perrin

InVivo Therapeutics (NASDAQ: NVIV) is biomaterial and medical device company focused on the treatment of spinal cord injuries. The company is developing a Neuro-Spinal Scaffold™ (NSS), a biocompatible polylactic-co-glycolic acid (PGLA) and poly-L-lysine (PLL) polymer scaffold that is designed for implantation at the site of the injury. The NSS provides structural support to the spared spinal tissue and a supportive matrix to facilitate endogenous repair processes as it degrades over several weeks.

InVivo is testing the NSS in a human clinical study called INSPIRE (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury). INSPIRE is designed as a 20-patient pivotal study to be used to support market approval under a Humanitarian Device Exemption (HDE) in the U.S. This is a landmark study, and one with significant importance to the company. To get an update on INSPIRE and provide additional information for investors on the future development plans with NSS and beyond, I spoke with InVivo's Chairman and CEO, Mark Perrin. 

Below is a transcript of our interview:

Friday, May 20, 2016

Is Relmada's d-Methadone The Next Big Thing?

While its mechanism of action remains unclear, ketamine, which has a moderately high binding affinity for, and can block the activity of, the N-Methyl-D-aspartic acid (NMDA) receptor, is making headlines as a breakthrough in the treatment of depression. Earlier in May 2016, a team of researchers out of the U.S. National Institute of Mental Health (NIMH) and the University of Maryland announced they may have discovered a potential breakthrough in the treatment of depression. The findings, published in Nature, highlight results from animal studies using a metabolite, or chemical byproduct, of racemic (R,S)-ketamine to reverse depression-like behavior (1).

Specifically, the group found that a single administration of a metabolite of ketamine, called hydroxynorketamine (HNK), resulted in rapid antidepressant-like effects in mice without ketamine-related side effects, such as anesthesia, or dissociative or addictive behavior. HNK, through unknown intermediates, increases the levels of another neuronal receptor protein, α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA). The data may implicate a novel mechanism underlying the antidepressant properties of racemic (R,S)-ketamine and have relevance for the development of next-generation, rapid-acting antidepressants (2).

Another recent Nature publication (3) offers a broader potential mechanism of action for the antidepressant effects of NMDA receptor antagonists. Rapid responses in subjects with treatment-resistant depression suggest a mechanism that results in fast changes in synaptic function and plasticity. Ketamine and other NMDA receptor antagonists increase mTORC1 signaling and increase synaptic number and function. Pre-administration of rapamycin, a selective mTORC1 inhibitor, blocks these effects. The paper suggests that NMDA receptor blockade increases glutamate transmission in rodents and humans via blockade of NMDA receptors on GABAergic interneurons. This release of GABA’s inhibitory effect activates AMPA receptors and stimulates mTORC1 signaling via the release of brain-derived neurotrophic factor (BDNF).

The mounting evidence for NMDA receptor modulation for the treatment of depression is relevant to Relmada Therapeutics (RLMD). Relmada announced last week news that its lead development candidate, d-methadone, produced statistically significant superior antidepressant-like effects to both ketamine and placebo in a preclinical study (4). Both Relmada's d-methadone and ketamine are NMDA receptor antagonists. Relmada has previously studied d-methadone in three safety and dose-ranging Phase 1 trials and believes the drug has potential utility for the treatment of neuropathic pain. These new findings with d-methadone open a new pathway for the company. A pivotal proof-of-concept Phase 2 study in depression and/or neuropathic pain is expected to commence during the second half of 2016. This is expected to be a major driver for the shares.

Thursday, May 19, 2016

Oryzon Genomics: Advancing Epigenetic Based Therapeutics (Update Following Q1-2016 Results)

Oryzon Genomics (MADX: ORY) is a clinical stage biopharmaceutical company headquartered in Barcelona, Spain. In December 2015, I provided a detailed overview of the company for investors (download the 19-page report). Oryzon is a leader in the development of epigenetics-based therapeutics. Epi is Greek for above, and genetics is the study of genes, heredity, and genetic variation in living organisms. As such, epigenetics is the study of “above the genes”, or more specifically, modifications that occur to the genes that results in activation or deactivation of gene expression that do not involve alterations in DNA sequence. These modifications are known as epigenetic modifications. The company is applying epigenetics to drug discovery and development through the regulation of gene transcription mediated by selective and reversible modifications to DNA and proteins.

These modifications have emerged as a key biological determinant of protein production and cellular differentiation, and play a significant pathogenic role in a number of human diseases. For example, reversible inhibition of protein expression through epigenetic modifications such as DNA methylation or histone alteration can be applied to disease-associated states, and creates a clear mechanistic pathway to target in the development of small molecule drugs as personalized therapeutics in diseases such as cancer, inflammatory diseases, metabolic diseases and neurodegenerative diseases. Below I provide an update to the Oryzon story for investors.

Wednesday, May 18, 2016

BriaCell Selects CRO To Run Phase 1/2 BriaVax Clinical Trial

BriaCell Therapeutics Corp. (TSXV: BCT) (BCFXF) continues to make progress on the initiation of its Phase 1/2a clinical trial with BriaVax™. This morning, the company announced it has signed a definitive agreement with Cancer Insight, LLC, a cancer-vaccine focused clinical research organization (CRO) to provide clinical and regulatory affairs management services for the trial. BriaVax™ is the company's proprietary whole tumor cell vaccine for the treatment of late-stage cancer. The company announced in April 2016 that plans to initiate the trial in the coming months. The trial is expected to enroll up to 24 late-stage cancer patients, mostly with metastatic breast cancer. BriaCell is also working on a companion diagnostic based on identified biomarkers aimed at prospectively identifying patients likely to benefit from BriaVax™.

I continue to be intrigued by BriaCell and what the company is doing in immuno-oncology. The stock is largely unheard-of by retail investors and flying so-far-below the radar of institutions that I believe a significant opportunity exists at today's ground-floor valuation. My article below is a quick review of the story, with a highlight on recent progress.

Monday, May 16, 2016

Interview With RedHill Biopharma CEO Sheds Light On Pricing, Strategy and Near-Term Catalysts

RedHill Biopharma Ltd (NASDAQ: RDHL) is a specialty pharmaceutical company with a total of eight drugs in various stages of clinical development, three of which are potential blockbuster drug candidates in Phase III for the treatment of gastrointestinal diseases. In total, RedHill is targeting over a dozen indications, with a core focus on gastrointestinal and inflammatory diseases.

Although relatively still unknown to retail investors, the company's institutional shareholder base includes highly creditable healthcare-focused firms such as Orbimed, Broadfin, Sabby, and Special Situations. The market capitalization is approximately $140 million, and, as of the end of the first quarter of 2016, roughly one-third of that ($53.4 million) is cash.

I believe the low market capitalization may be based on some misconceptions over strategy or the difficult overall specialty pharmaceutical market. To shed some light on the company’s strategy, highlight some near-term catalysts, and touch on what is a hot-button issue in specialty pharma these days, i.e. pricing, I spoke with the company’s CEO, Dror Ben-Asher.

Wednesday, May 11, 2016

22nd Century Beats On Revenues; Shares Attractively Valued

On May 10, 2016, 22nd Century Group, Inc. (XXII) reported financial results for the first quarter ending March 31, 2016. Revenues for the quarter totaled $3.02 million, up 390% over the first quarter 2015. Revenues exceeded the only published estimated of $2.55 million by Chardan Capital (link), as well as my estimate of $2.75 million. Net loss for the quarter totaled $3.25 million, or $0.04 per share. 22nd Century exited March 2016 with approximately $6.05 million in cash and investments. Operating burn during the first quarter totaled $2.8 million. As such, I believe the company has cash to support operations into October 2016.

Tuesday, May 3, 2016

22nd Century Licenses Revolutionary Cigarette Filter To Expand Reduce Harm Strategy

Last month we published a transcript of our interview with 22nd Century Group Inc. (NYSEMKT: XXII) President & CEO, Henry Sicignano III. The key issue we discussed with Mr. Sicignano during our interview was the rollout of the company's MAGIC® Very Low Nicotine brand cigarettes in Europe and a filter supply bottleneck that seemed to hold back the ramp-up in sales over the past few months. We find this issue incredibly important to the stock because the success of MAGIC® in Europe should serve as a proxy for the market opportunity with BRAND A, a similar very low nicotine brand cigarette under U.S. FDA review, in the U.S. On May 2, 2016, investors got some very good news with respect to MAGIC® and a new, potentially revolutionary, cigarette filter.

Monday, May 2, 2016

CoLucid - Facts About Migraine

This article is a quick introduction to CoLucid Pharmaceuticals (NASDAQ: CLCD) and the company's  first-in-class 5-HT1F receptor agonist, lasmiditan (COL-144), for the acute treatment of migraine. An oral formulation of lasmiditan is currently in Phase 3 development and an intravenous formulation for use in the emergency room setting is in Phase 2 clinical trials.

The Phase 3 clinical trial, called SAMURAI, is a randomized, double-blind, placebo-controlled study in subjects with a disabling migraine (MIDAS score ≥ 11) designed to enroll 2,225 patients into one of three arms: lasmiditan 100 mg, lasmiditan 200 mg, or placebo. The primary outcome is the proportion of subjects headache pain-free at two hours post-dose. CoLucid has received a U.S. FDA Special Protocol Assessment (SPA) agreement for the SAMURAI study. I expect top-line data during the third quarter 2016.

I will follow in the coming months with a detailed analysis of lasmiditan, the clinical data, the market opportunity, CoLucid's path to market, and what the shares might be worth if the pending SAMURAI trial with lasmiditan is positive. However, for today, given that CoLucid just published some interesting "Migraine Facts", I thought we would start with a simple introduction to migraine headaches, with some interesting facts of which investors might not be aware.