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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 - BioPsi 5C

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.

Wednesday, April 19, 2017

NurOwn Shows Potential In Preclinical Autism Model

On April 19, 2017, BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the publication of preclinical data on NurOwn® demonstrating potential utility in the treatment of autism. The research is published in Behavioural Brain Research and highlights the long-term beneficial effect of BrainStorm's NurOwn (neurotrophic factors-secreting mesenchymal stem cells) transplantation in the BTBR mouse model of autism (1). The company plans to pursue clinical development with NurOwn as a potential treatment for autism later this year. A Phase 3 clinical study with NurOwn as a potential treatment for amyotrophic lateral sclerosis (ALS) is also expected to begin in 2017.

Friday, April 14, 2017

Participation From Top BMT Centers Positions SIERRA For Success

Actinium Pharmaceuticals' (ATNM) Iomab-B is an induction and conditioning agent designed to enable patients with relapsed or refractory acute myeloid leukemia (AML) to receive a bone marrow transplant. Iomab-B was developed by scientists at the Fred Hutchinson Center Research Center, an organization with three Nobel Prizes in physiology and medicine. Actinium is currently enrolling patients in a Phase 3 trial is called SIERRA.

BMT is the only curative option for patients with AML and Iomab-B comes from an excellent pedigree. Fred Hutchinson is a recognized leader in the field of BMT and previous data with Iomab-B shows an impressive increase in overall survival compared to the current standard of care (1). Fred Hutchinson is obviously one of the participating centers in the Phase 3 SIERRA trial. However, what I find equally impressive is the current participation in SIERRA by some of the other leading BMT centers in the U.S. I think this positions SIERRA well for success when data read-out in 2018.

Thursday, April 6, 2017

MabVax Posters Highlight Why I Like This Story

Earlier this week, MabVax Therapeutics, Inc. (NASDAQ: MBVX) presented two posters on MVT-1075 at the American Association for Cancer Research (AACR) annual meeting. MVT-1075 is the companies fully human antibody-based radioimmunotherapy (RIT) currently ready for Phase 1 clinical development, initially being evaluated for the treatment of pancreatic cancer and other CA19-9 malignancies. The posters highlight the excellent preclinical proof-of-concept and manufacturing / scale-up commercial viability of MVT-1075.

I'm a big fan of MabVax and MVT-1075. The preclinical data, which I cover below, look outstanding. I'm also encouraged by the initial clinical data with MVT-5873 (the cold antibody) and MVT-2163 (the PET imaging agent). Finally, there looks to be a number of catalysts on the horizon that should help the stock trend higher. These include presented additional data on MVT-5873 and MVT-2162 and closing a financing transaction to fund operations well into 2018.

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 29, 2017

MAT2501 Phase 1 Data Look Good, Shares Look Attractive

On March 27, 2017, Matinas Biopharma (MTNB) reported positive topline results from a Phase 1 single ascending dose study of MAT2501 in healthy volunteers. MAT2501 is the company's oral lipid-crystal formulation of amikacin. Amikacin is a powerful antibiotic with limited bacterial resistance. Unfortunately, the injectable formulation of the drug has poor tolerability and high incidence of series adverse events, including severe nephrotoxicity and ototoxicity. The U.S. FDA recommends strict monitoring of amikacin blood levels to avoid these risks.

Although multi-dose studies are still necessary, the results of Matinas' Phase 1 study suggest that oral doses of MAT2501 can safely be administered without raising the concentration of amikacin in the blood to levels known to cause series adverse events. Matinas is developing MAT2501 to treat different types of chronic and acute bacterial infections, including nontuberculous mycobacterium (NTM) infections and various multidrug-resistant Gram negative bacterial infections.

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.

Tuesday, March 21, 2017

EMA Gives Thumbs-Up To Actinium's Phase 3 SIERRA Program

This morning, Actinium Pharmaceuticals (ATNM) announced that the company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for Iomab-B. According to the press release, correspondence from the EMA notes that the trial design, primary endpoint and planned statistical analysis of the U.S. pivotal Phase 3 SIERRA trial are acceptable and can serve as the basis for submission of a Marketing Authorization Application (MAA) in Europe.

In addition, the EMA commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies on Iomab-B prior to reviewing the MAA. The EMA did request some supporting data; but, management noted that this information is already being collected as part of the U.S. pivotal Phase 3 SIERRA trial.

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

BrainStorm Strengthens Management Team, Expands Board

Over the past month, BrainStorm Cell Therapeutics (NASDAQ: BCLI) has made a significant effort to increase the credibility of the story to investors. On March 6, 2017, the company announced that Ralph Z. Kern, Senior Vice President and Head of Worldwide Medical at Biogen, will join the company as Chief Operating Officer (COO) and Chief Medical Officer (CMO). The hiring of Dr. Kern brings an instant credibility boost to BrainStorm. The news follows the announcement last month when BrianStorm appointed two new independent members to its Board

Credibility is one of my 5 C's of Biotech Investing™ and a major driver of investor confidence. I'm a fan of BrainStorm and its cell therapy platform for the treatment of neurodegenerative diseases. The company has a high Charisma score, which is my assessment of the technology platform and the market potential for leading product, NurOwn®. However, Credibility has been lacking and an issue for a well-known industry guru. These three new well-respected members of the BrainStorm team, along with positive commercial and logistical announcements on manufacturing and cryopreservation earlier in the year, are clearly moving BrianStorm in the right direction.

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.

Wednesday, March 1, 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. 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 acquired.

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.