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Wednesday, June 14, 2017

RedHill Reports Positive Phase 3 For Bekinda, Launches Donnatal and EnteraGam

This morning, RedHill Biopharma Ltd (RDHL) reported positive top-line results from the Phase 3 GUARD study investigating BEKINDA® 24 mg for the treatment of acute gastroenteritis and gastritis. Below is a quick review of the top-line results. RedHill will host a conference call on June 21st at 8:00 AM ET to provide additional analysis and discuss the data with investors.

Yesterday, the company announced the initiation of promotional activities for two gastrointestinal specialty products in the U.S., Donnatal® and EnteraGam®. This is an important step for the company on its path to transform into a fully-integrated commercial organization with a primary focus on gastrointestinal and inflammatory diseases. Besides Bekinda for acute gastroenteritis, RedHill's Phase 3 pipeline contains two additional GI-focused assets, RHB-104 for Crohn's disease and RHB-105 for H. pylori infection.

Thursday, June 1, 2017

HedgePath Granted Type C Meeting With FDA

On May 30, 2017, HedgePath Pharmaceuticals, Inc. (HPPI) announced the company has been granted a Type C meeting with the U.S. FDA to discuss the interim results from the company's Phase 2b clinical study of SUBA-Cap (SUBA-Itraconazole) in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS). A response is expected in July 2017.

Friday, May 19, 2017

Initial Look At Bio5C Performance

I was saving this analysis for June, but since a few of you guys have asked me for metrics on Bio5C performance, I'll share what I have as of today. I started to score biopharma companies for Bio5C in February 2017. The service has come a long way since then. Back in February, all I had was one tab in excel with the 5C score. Now, subscribers get an excel file updated daily that has 6 tabs and research reports on two dozen names. Luckily, I saved the Bio5 score for all the names in the model on March 1st. I've added a handful of stocks since March 1st, and those are now included in the model as well.

The results are excellent - better than I expected actually! I graphed the Bio5C score on the X-axis vs. the 3-month stock return on the Y-axis and got a pretty decent R-squared score of 0.55. However, importantly, the trend line looks fantastic and the stratified data look outstanding!

Monday, May 15, 2017

Continued Progress, Promise with Oryzon's Pipeline

Last week, Oryzon Genomics (MADX: ORY) reported financial results and provided a corporate update following the end of the first quarter 2017. The company made a number of advancements during the first quarter, including successfully completing a Phase 1/2a clinical trial with ORY-1001 in acute leukemia. Preliminary data was presented at the American Society of Hematology (ASH) meeting in December 2016. With the final data now analyzed, Oryzon has passed off future development of ORY-1001 to commercial partner, Roche.

Oryzon also presented preliminary Phase 1 data from ORY-2001 at the 13th International Conference on Alzheimer's and Parkinson's Disease. The positive safety and pharmacologic data, along with confirmed proof-of-concept, positions Oryzon to move into Phase 2 studies later this year. Finally, pre-IND work on ORY-3001 continues, with the goal to file later in 2017.

Oryzon also raised €18 million in cash during the first quarter through a private placement with U.S. and European investors. As a result, the company exited the quarter with $29.8 million in cash and marketable securities. The solid cash position is sufficient to fund Oryzon for the foreseeable future. Below is a detailed update on the pipeline for investors.

Thursday, May 11, 2017

BriaCell Doses First Patient In Phase 1/2 Clinical Study With BriaVax

Earlier this week, BriaCell Therapeutics Corp. (TSXV: BCT) (BCTXF) announced that the first patient has been dosed in the company's Phase 1/2a clinical trial of BriaVax™ for the treatment of advanced breast cancer. This is an important step for the company and represents many years of hard work by management to get BriaVax back into human clinical trials. I think BriaVax has tremendous potential as a targeted immunotherapy, so I'm excited to see the company moving forward and finally dosing patients.

Wednesday, May 10, 2017

Journal Article Highlights How BioSig's PURE EP Beats The Competition

The April 2017 issue of the Journal of Innovations in Cardiac Rhythm Management has an excellent paper on why BioSig's PURE EP™ is a superior electrophysiology signal recording and processing system to existing systems and positioned to shake-up the entire EP market when launched in 2018. The paper was published by a team of cardiologists and electrophysiologists at Mayo Clinic, Harvard Medical School, and BioSig Technologies, Inc. (BSGM).

The paper is titled, "Initial Experience with the BioSig PURE EP Signal Recording System: An Animal Laboratory Experience" and is rather technical. Investors wishing to read the paper can simply click on JI-CRM logo and it will pop open the PDF. Below is my summary of the key findings by the team of physicians and what this means for investors in BioSig Technologies.

Friday, April 28, 2017

AV-101 Shows Potential In Model of Neuropathic Pain

On April 27, 2017, VistaGen Therapeutics (NASDAQ: VTGN) announced the publication of preclinical data in the Journal of Pain highlighting the potential therapeutic effect of AV-101 for treating neuropathic pain. Scientists from the University of California, San Diego and the University of Maryland School of Medicine, in collaboration with VistaGen Therapeutics, demonstrated the utility of AV-101 in four well-established nonclinical rodent models of pain. The work was supported by VistaGen Therapeutics and research grants provided by the U.S. NIH.

Tuesday, April 25, 2017

BioSig Provides Shareholder Letter - April 2017

BioSig Technologies, Inc. (BSGM) provided an update for investors via a Shareholder Letter posted on the company's website this morning. The letter highlights some of the recent positive developments for the company, including the collaboration with Mayo Clinic and the recent $5.0 million financing. I am optimistic about the future of BioSig and PURE EP™, a novel surface electrocardiogram (EKG) and intracardiac multichannel recording and analysis system.

Monday, April 24, 2017

New Biotech Research Service - Bio5C

I've been a stock analyst since 1999. I've focused solely on biopharma names since 2003. I've seen a lot of success and a lot of failures. It's amazing to me how many small biopharma companies continue to make the same mistakes, over, and over again. I've researched drugs with novel mechanisms of action that look outstanding in preclinical studies, only to see them fail once they hit the clinic. I've also witnessed repurposed agents that bafflingly succeed in new indications where the market wagered little hope. I've seen good drugs fail because of bad business models and terrible management and bad drugs succeed because of good business models and brilliant management. There is no true formula for success, but there are a number of roadblocks and red flags.

Thursday, April 6, 2017

Let's Talk Depression And How To Play The NMDA Buzz

April 7th is World Health Day. It's celebrated every year on the 7th to mark the anniversary of the founding of the World Health Organization (WHO). WHO is a specialized agency of the United Nations with a primary focus on concerns of international public health. In its 69 year existence, WHO has played a major role in combating diseases on a global basis, including eradicating smallpox and fighting pandemics such as HIV/AIDS, Ebola, malaria, and tuberculosis. However, the theme for 2017 is a bit different from the past focus on communicable diseases. For 2017, WHO is targeting depression.

The involvement of WHO is likely to bring significant media attention and public awareness to depression. This marries well with recently media coverage and scientific publications around ketamine and NMDA receptor targeting as a novel strategy to treat depression. For the purpose of this article, I look at three companies targeting depression through NMDA pharmacology and which of these names might offer the best returns over the next year or two.

Tuesday, April 4, 2017

YELIVA Granted Orphan Drug Designation In Cholangiocarcinoma

On April 4, 2017, RedHill Biopharma Ltd (NASDAQ: RDHL) reported that the U.S. FDA granted YELIVA® Orphan Drug (OD) designation for the treatment of cholangiocarcinoma. Cholangiocarcinoma (bile duct cancer) is a rare malignancy that affects roughly 8,000 individuals in the U.S. each year (1). Survival rates are highly dependent on location and stage of disease, but it is clear that there are limited treatment options for these patients. By winning OD designation for YELIVA, RedHill will benefit from various development incentives, including tax credits, a waiver of PDUFA fees, and guaranteed seven years of market exclusivity post approval.

Wednesday, March 22, 2017

Why I'm Long Shares Of HedgePath Pharma

I am long shares of HedgePath Pharmaceuticals (HPPI) because I believe the stock represents a compelling investment opportunity at today's price. HedgePath is a biopharmaceutical company developing an improved formulation of itraconazole for the treatment of Basal Cell Carcinoma Nevus Syndrome (BCCNS). The drug, called SUBA™-Cap, is currently being investigated in a Phase 2b clinical trial. Preliminary data from the study reported in October 2016 look excellent and the potential exists that HedgePath may be in a position to seek U.S. FDA approval upon successful completion of the final results expected later in 2017.

Below is a comprehensive review of HedgePath Pharma for investors.

Thursday, March 16, 2017

BioSig Secures Cash, Partners With Mayo, And Prepares For PURE EP Approval

Over the past month, BioSig Technologies, Inc. (BSGM) raised roughly $1.5 million in cash through the sale of nearly one million shares of common stock to accredited investors, which included participation from insiders, at $1.50 per share. Participants in the offering also received warrants to purchase one-half a share at $1.50 that if exercised, would raise an additional $750,000. Additional details on the financing can be found in the SEC 8K filing.

The new cash will help BioSig complete the necessary 510(k)-enabling work currently underway on PURE EP before the filing expected in the third quarter 2017. This work position PURE EP for market approval in the fourth quarter 2017, which would be a major milestone for the company. Below is a quick update outlining the company's progress.

Wednesday, March 15, 2017

BriaCell Phase 1/2a Trial Underway

On March 15, 2017, BriaCell Therapeutics Corp. (TSXV: BCT) (BCTXF) announced that the U.S. FDA had granted clearance to initiate the Phase 1/2a clinical trial of BriaVax™ in patients with advanced breast cancer. This is an important step for the company and represents many years of hard work by management to get BriaVax back into the clinic, including finalizing the necessary CMC work around a new manufacturing process for the whole-cell vaccine.

I'm expecting the first patients to be dosed shortly. The principal investigator is Dr. Jarrod P. Holmes at St. Joseph Heritage Healthcare in Santa Rosa, California. Dr. Holmes is a Board Certified Oncologist and a leading expert in cancer vaccines. Cancer Insight, LLC, led by Dr. George Peoples, a surgical oncologist and leading expert in cancer vaccines, is managing the clinical study. Biologics Consulting is handling regulatory affairs.

Monday, March 6, 2017

Oryzon's Pipeline Taking Shape

My last update on Oryzon Genomics (MADX: ORY) was in December 2016 after the company presented encouraging Phase 1/2a data at the American Society of Hematology (ASH) meeting with ORY-1001. ORY-1001 is the company's potent and highly selective Lysine Specific Demethylase 1 (LSD1) inhibitor under development for the treatment of acute myeloid leukemia (AML) and small cell lung cancer (SCLC).

The Phase 1/2a data presented at ASH demonstrate excellent safety and tolerability, along with initial signs of therapeutic effect in leukemia. The most pronounced effect was observed in patients with a specific FAB subtype of leukemia known as M6/AML. Oryzon's partner, Roche, has taken over the development of ORY-1001 (now called RG6016) for further clinical studies.

Since December, Oryzon has had a number of positive updates for investors, including advancements with its pipeline and the financial position. Below is a look at some of the recent news since ASH and some thoughts on the financial results released last week.