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Tuesday, September 27, 2016

Can-Fite An Emerging NASH Play With CF102

Last week, Allergan plc (AGN) acquired two companies on the same day, both in an effort to strengthen its focus on NASH. Allergan spent $615 million to acquire Tobira Therapeutics, Inc. (TBRA) and $50 million to acquire privately-held Akarna Therapeutics. The acquisition of Tobira gives Allergan cenicriviroc, an oral Phase 3 ready potent inhibitor of the chemokine receptors, CCR2 and CCR5, which are involved in the inflammatory and fibrogenic pathways in NASH and evogliptin, an oral DPP-4 inhibitor in Phase 1 studies for NASH. Allergan also committed to pay shareholders of Tobira another billion dollars in potential milestones upon the successful development of cenicriviroc and evogliptin. The smaller acquisition of Akarna brings in AKN-083, a preclinical farnesoid X receptor (FXR) agonist for the treatment of NASH that Allergan believes is complementary with cenicriviroc and evogliptin.

Allergan's double acquisition day last week reinforces what investors already know - NASH plays are hot and getting scooped up by big biopharma companies left and right. Many consider Intercept Pharmaceuticals (ICPT) the market leader in NASH, with Gilead Sciences (GILD), Genfit SA (GNFTF), Novartis (NVS), Shire Plc (SHPG), Bristol-Myers (BMY), Merck (MRK), and the aforementioned Allergan all making a strong push into the billion-dollar market. Gilead recently paid $400 million to acquire privately-held Nimbus Therapeutics and its Phase 1 asset, acetyl-CoA carboxylase. In January 2015, Gilead acquired an FXR agonist from privately-held Phenex Pharmaceuticals for $470 million

The deal flurry in NASH last week caused several small-cap biopharma companies to increase in value as investors speculate on who will be acquired next. Galmed Pharmaceuticals (GLMD), Conatus Pharmaceuticals (CNAT), and Galectin Therapeutics (GALT) all soared on the news. Can-Fite Biopharma (CANF) also popped on the news. Can-Fite is a somewhat under-the-radar NASH play. I've written extensively on the name, but tend to focus most of my analysis on CF101, which is Phase 3 ready in both rheumatoid arthritis and psoriasis. For the purpose of this article, I'll look at CF102 for liver disease, including NASH, an opportunity that I do not believe the market is aware of and has the potential to send Can-Fite shares soaring in 2017.

Monday, September 26, 2016

Here's Why Revive Will Close The Valuation Gap With Peers

Revive Therapeutics (TSXV: RVV) (RVVTF) Looks Significant Undervalued

Valuing small and micro-cap biopharma companies is a difficult task. Most have no revenues, let alone earnings where valuation multiples can be applied. And even when revenues or earnings do exist, the market can be fickle on what specific multiples to apply. Discounted cash flow seems to be the tool of choice for many professional investors, but that too is highly subjective and at the mercy of inputs like discount rates, terminal values, and predicting peak sales.

There is one truth however that investors can generally feel comfortable applying when looking at the valuation of small and micro-cap biopharma companies. That is, the later the stage of development the more valuable the asset. Though not a perfect linear equation, a company with a Phase 3 drug in development will likely be valued higher than a company with a Phase 2 drug, or Phase 1 drug, etc. Additionally, the size of the market and the existing competition plays an important role in valuation as well. Again, nothing is an exact science, but the larger the market and the fewer the competitors, the better.

I've been spending a lot of time lately looking at rare diseases. While they may not be terribly large markets, often there is minimal competition and room for aggressive pricing. Orphan drug designation and the potential for things like Priority Review and Fast Track status also help to increase the valuation of small and micro-cap biopharma stocks.

Thursday, September 22, 2016

Recent News From BriaCell Points To Meaningful Progress

BriaCell Therapeutics Corp. (TSXV: BCT.V) is one of my favorite under-the-radar micro-cap immuno-oncology stories. The company is developing BriaVax™, a proprietary allogeneic whole tumor cell vaccine for the treatment of late-stage breast cancer. Management is preparing to initiate a Phase I/II clinical study with BriaVax in the fourth quarter 2016. The company is currently completing manufacturing of the vaccine for the clinical study.

BriaCell has announced some positive incremental news over the past few months since I first started following the story about a year ago. For instance, BriaCell recently appointed NY-based RK Equity Advisors LLC and TrueNorth Lifesciences LLC for the provision of corporate advisory services. Pursuant to the Agreement, RK and TruthNorth will assist BriaCell in engaging select members of the international investment community, with a focus on increasing awareness of BriaCell and its unique growth strategy, as well as assisting with the commercialization of its product and other market opportunities.

The start of the Phase I/II clinical study initiates a meaningful catalyst for the shares. And given that BriaCell is now actively out and talking with investors, as well as engaging with advisory and investor relations firms to increase awareness, I thought it made sense for me to do a quick review of the story and highlight why I'm a fan of the company.

Wednesday, September 21, 2016

VBI's Sci-B-Vac Should Take Market Share In The Hepatitis B Vaccine Market

VBI Vaccines, Inc. (Nasdaq: VBIV) is a biopharmaceutical company developing next-generation vaccines for infectious diseases and immuno-oncology. The company was formed from a merger between SciVac Therapeutics, Inc. and VBI Vaccines, Inc. in May 2016. VBI markets a third-generation hepatitis B vaccine called Sci-B-Vac™ that is currently available in Israel and 14 other countries outside the U.S. and Europe. Sci-B-Vac is under development for the U.S. and EU market.

In addition, the company is developing vaccine candidates for cytomegalovirus (CMV), respiratory syncytial virus (RSV), and Zika virus utilizing the enveloped virus-like particle (eVLP) technology. An immuno-oncology product is also in development targeting CMV expression in patients with glioblastoma multiforme (GBM). For the purposes of this article, I will focus on the opportunity for Sci-B-Vac.

Monday, September 19, 2016

MabVax Phase 1 Trial With HuMab-5B1 Progressing Nicely

On September 19, 2016, MabVax Therapeutics, Inc (NASDAQ: MBVX) provided a brief update on the ongoing Phase 1 clinical trial testing the safety and tolerability of MVT-5873 as a monotherapy and with chemotherapy in subjects with advanced prostate cancer. MVT-5873 is the company's fully human monoclonal antibody, HuMab-5B1, that targets the tetrasaccharide carbohydrate moiety sLeA (also known as CA19.9). MabVax has accumulated data that shows sLeA is expressed abundantly on a number of different tumor types, including up to 92% of pancreatic cancers.

Below is a quick review of the MabVax Phase 1 trial and the interim update.

Immune Forms Pain & Neurology Spin-Off Called Maxim Pharma

Last week, Immune Pharmaceuticals, Inc. (NASDAQ: IMNP) announced the formation of a pain and neurology focused subsidiary that will own worldwide rights to AmiKet™ and Amiket™ Nano for the treatment of neuropathic pain, along with all the intellectual property around both key assets. The new company, called Maxim Pharmaceuticals, Inc., is wholly-owned by Immune Pharma at this time; however, Immune has also entered into a binding agreement with a syndicate of experienced healthcare investors to purchase up to $20 million Maxim capital stock, with an initial investment of $5 million expected in the next 30 days.

The creation of a pain and neurology focused subsidiary is an important step towards realizing what Immune believes is the significant value of AmiKet for shareholders. Below is a quick review of AmiKet, the transaction, and what to expect over the next several months at Maxim Pharma.

Wednesday, September 14, 2016

Actinium Pharmaceuticals: Well Positioned For A Breakout 2017

Actinium Pharmaceuticals (NYSEMTK: ATNM) is a biopharmaceutical company developing targeted radioimmunotherapies for the treatment of cancer. The company has two clinical-stage programs, Iomab-B and Actimab-A. Iomab-B was licensed from the Fred Hutchinson Cancer Research Cancer and is currently in a pivotal Phase 3 clinical trial investigating the use as an induction and conditioning agent prior to a bone marrow transplant in elderly patients with relapsed or refractory Acute Myeloid Leukemia (AML). Actimab-A was licensed from the Memorial Sloan Kettering Cancer Center and is currently in a Phase 2 clinical trial investigating the use as an induction agent in newly diagnosed elderly patients with AML.

The company also has a proprietary alpha particle immunotherapies (APIT) platform and the exclusive right to license additional targeted immunotherapy drug candidates. Below is a quick overview of Actinium Pharma and why I believe that the company is positioned for a breakout year in 2017.

Tuesday, September 13, 2016

Exactus' FibriLyzer Device Solves A Big Problem For Surgical Patients

A rapid, point-of-care diagnostic for the detection of hyperfibrinolysis is a blockbuster medical device. I am a shareholder in Exactus Inc. (EXDI), and I believe the company's FibriLyzer™ product is such a potential device. Below is an introduction to blood hemostasis, the importance of monitoring fibrinolysis during surgery or in patients with trauma, and why Exactus' Fibrilyzer™ could be a significant leap forward for healthcare providers in operating room (OR), emergency room (ER), and potentially even out in the field.