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Wednesday, July 19, 2017

BriaCell Clinical Update Shows Progress With Breast Cancer Program

BriaCell Therapeutics Corp. (TSXV: BCT) (OTC: BCTXF) continues to enroll patients in its Phase 1/2a clinical trial of BriaVax™ for the treatment of advanced breast cancer. The third patient enrolled earlier this week, making it three patients over the past three months. Management is expecting that pace to accelerate in the coming weeks, and now believes that the first ten patients will enroll by the end of September 2017. An interim data analysis of these first ten patients should be available during the first quarter 2018, setting up a nice potential catalyst for the shares.

Reporting data on BriaVax in patients with advanced metastatic breast cancer will be an important milestone 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 a nice catalyst on the horizon.

Monday, July 17, 2017

Can-Fite Gearing-Up For Phase 2 NASH Program

CanFite Biopharma Ltd (CANF) is preparing to initiate a Phase 2 clinical study examining namodenoson (formerly CF102) for the treatment of NAFLD/NASH. Investigator meetings have recently completed and patient enrollment is set to begin shortly. Can-Fite estimates the cost of the 60 patient Phase 2 trial will be under $1 million. Namodenoson supplies are ready to be administered and the costs of supply have already been paid.

Over the past several months, the company has been releasing preclinical data with namodenson demonstrating the drug reduces NAFLD Activity Score, micro- and macrovesicular fat deposits, decreased plasma ALT and triglycerides levels, prevents progression of liver fibrosis, and protects against ischemia and reperfusion injury in transplant models.

Quite simply, namodenoson looks like a pan-hepatic improver of liver pathology, applicable to earlier-stage liver diseases such as NAFLD and NASH, for the treatment of ischemia / reperfusion (I/R) injury in patients following partial hepatectomy, and in the treatment of primary liver cancer, including advanced hepatocellular carcinoma (HCC). I think this makes namodenoson an incredibly attractive asset for a potential larger biopharma company to acquire should the Phase 2 trial succeed.

Below is a look at the current status of namodenoson and the preclinical data in NAFLD/NASH ahead of the planned Phase 2 trial later this year.

Friday, June 30, 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!

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, 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.


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.

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.

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, 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.