Neurotrope: A Company You Never Heard Of Might Have The Biggest Drug Ever In Biotech

Neurotrope Inc NTRPD 11.68%, a clinical stage biopharmaceutical company, may have found through its drug Bryostatin a unique solution to addressing Alzheimer's, one of the last major diseases with no cure.

Benzinga recently spoke with CEO Dr. Susanne Wilke, ahead of her appearance at the Noble Financial Annual Investor Conference on January 30.

The Runaway Disease

"It's a runaway disease at the moment," Dr. Wilke said of Alzheimer's. "Everybody has a story of somebody in their family who has Alzheimer's."

What sets Neurotrope apart from what it calls "the current hypothesis" of treating Alzheimer's by focusing on neuronal loss, is its choice to instead zero in on regenerative methods to replace lost synaptic networks that are consistently associated with the breakdown of human cognitive functions.

"In the current hypothesis," Wilke explained, "we take amyloid plaque and tau tangles - which kind of strangulate the neuron and then you have neuronal loss - as being causative for Alzheimer's. What we are saying is, maybe that is true, but it may not be causative."

Before you get to neuronal loss, you probably will have synaptic loss - the loss of synaptic networks - and that's where Neurotrope's Bryostatin looks to be revolutionary.

Bryostatin, by activating the system to restore these synapses, seeks to actually reverse Alzheimer's.

"This is a kind of a heresy in the field right now," Wilke said.

Looking Beyond Alzheimer's

"We believe that this mechanism is a fundamental mechanism for neurodegenerative diseases in general. We definitely want to go into Fragile X [syndrome], we are thinking about Rett Syndrome. There's other areas. Obviously stroke, Parkinson's, depression may be an area."      

Neurotrope's Bryostatin, developed at the Blanchette Rockefeller Neurosciences Institute, has been shown to be effective even in Alzheimer's patients with gene mutations. It's currently being studied in a Phase 2 Clinical Trial with top-line data expected in April, a month after the company expects to list on the NASDAQ.

Market Opportunity

The market may be waking up to Neurotrope's potential, as over-the-counter shares of the company have risen more than 18 percent this week. When asked about the total addressable market for Bryostatin, Neurotrope's Director Of Corporate Communications Jeff Benison put it into perspective.

Last year, Benison recalled, Sam Isaly from OrbiMed spoke at the Bio CEO & Investor Conference, speaking about the biotech market in general.

"His comment was, when an Alzheimer's drug gets approved that actually does something to treat the disease and not the symptoms of the disease, that would be the largest drug in the history of pharmaceuticals," Benison said.

By Taylor Cox

Source: http://www.benzinga.com/general/biotech/17/01/8960221/neurotrope-a-company-you-never-heard-of-might-have-the-biggest-drug-ev

Three Biotech Companies With Large Upside Potential

Here's a look at three small-cap biotech stocks looking to capitalize on their novel technologies and solid management:

Sophiris Bio Inc (NASDAQ: SPHS)

Sophiris’s lead drug, PRX302 (topsalysin), is being evaluated for the treatment of urological diseases. PRX302 is a recombinant protein that has been modified to be activated exclusively by an enzyme in the prostate, allowing PRX302 to kill all cells with GPI receptors. PRX302 removes damaged cells by binding to their GPI-anchored receptors, which it turns into transmembrane pores. This causes cell content to leak out, killing the damaged cell without affecting healthy cells in the surrounding tissue.

PRX302 has been tested in eight clinical trials. In late 2015, the drug met the primary endpoint of a Phase 3 clinical trial as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia (BPH). Patients treated with PRX302 demonstrated a 7.60 point improvement in International Prostate Symptom Score (IPSS) over a year-long period. Another promising result from PRX302’s trial was the lack of any evidence that the therapy causes sexual or cardiovascular side effects. Not causing these side effects would give Sophiris’s therapy a distinct competitive advantage over current pharmaceutical BPH treatments, which lack sustainable efficacy and often lead to sexual dysfunction. An absence of side effects would also give PRX302 an advantage over surgical procedures for BPH, which are invasive and frequently lead to impotence and incontinence. An estimated 36 million men in the U.S. are affected by BPH, and three million are prescribed pharmaceuticals for this condition each year, giving PRX302 very large market potential. The company believes that an “improvement in IPSS total score, if replicated in a second Phase 3 trial, may be sufficient for registration with the FDA”. This means Sophiris may be a single successful trial away from commercializing a drug for millions of Americans.

BioVie Inc (OTC: BIVI)

BioVie (formerly Nanoantibiotics Inc) is a new Biotech Company that is developing a new standard of care for patients suffering from liver cirrhosis.  The company is developing a groundbreaking therapeutic approach that may be be the first successful treatment of life threatening ascites due to liver cirrhosis.

BioVie’s platform technologies target ascites formation at its “mechanistic source,” by blocking the activation of neuro hormonal signals, thereby alleviating portal hypertension and correcting splanchnic vasodilation. The Company’s lead asset is its patented BIV201, which just received orphan drug designation by the FDA. The drug, which can be given in a hospital or outpatient setting, enables the body to increase effective blood volume and reduce unwanted chemical signals to the kidneys. 

The market for a new drug to treat Ascities is significant with over 20 million people worldwide living with Ascites. This year alone, the number of people who are affected by this debilitating condition is increasing by 10%. The total addressable market for a new drug for ascites could potentially exceed $500 million in the US, as there are no current products on the market to achieve the therapeutic benefit expected with BIV210.

The Company is also leveraging its platform technology to help patients with other forms of Liver Disease such as Esophageal Variceal Bleeding (EVB), NASH, and Hepato-renal syndrome type 1 and type 2. Since BIV201 is a new drug that blocks activation of neuro hormonal signals and targets Ascites formation at its mechanistic source, the Company’s final stage of its technologies development is to target patients with pre-liver/kidney transplantation, septic shock, and hyponatremia.

When investing in MicroCap companies, management is the driving force between success and failure. At the helm of BioVie is a rock star management team that includes Jonathan Adams MBA, as CEO, and Cuong Do MBA, as Director.

Mr. Adams has had a very successful track record in pharma/biotech since graduating with his MBA from Dartmouth/Tuck. Mr. Adams has over 26 years of experience in the pharma industry, including at Searle Pharmaceuticals where he was a member of the global launch team for Celebrex, a multi billion dollar drug.

Another key member of the BioVie team is Cuong Do, who brings decades of industry experience. Mr. Do  is currently Executive Vice President, Global Strategy Group, Samsung. Mr. Do helps to set the strategic direction for Samsung Group’s diverse business portfolio. He was previously the Chief Strategy Officer for Merck, a leading US pharmaceuticals company, Tyco Electronics, and Lenovo. Mr. Do was a former senior partner at McKinsey & Company, where he spent 17 years and helped build the healthcare, high tech and corporate finance practices. Mr. Do holds an MBA from the Tuck School of Business at Dartmouth.

Overall, BioVie’s strong team and groundbreaking new treatment, give this company massive upside potential. This makes BioVie a potent pick for investors as the Company is currently set to begin human clinical trials on its groundbreaking therapy this year. 

Idera Pharmaceuticals Inc (NASDAQ: IDRA)

Idera is a company that is devoted to developing and commercializing original cutting-edge treatments for diseases such as cancer and rare diseases. The company is led by CEO Vincent Mialno, who was previously CEO of ViroPharma, which was acquired by Shire Pharmaceuticals for over 4 billion dollars. The brains behind Idera’s technology comes from  Sudhir Agrawal whose  scientific breakthroughs have been reported in more than 300 research papers and reviews and is an inventor on more than 300 patents issued or pending around the world. 

The Company is developing nucleic acid therapies that can control immune responses to be more targeted. These therapies include two unique technologies: toll-like receptor (TLR) immune modulation and a proprietary third-generation antisense platform. 

The primary treatment in Idera’s pipeline is called IMO-8400, an antagonist of endosomal Toll-like receptors(TLRs) 7,8 and 9, is in Phase I/II clinical trials for the treatment of Waldenströms Macroglobulinemia and diffuse large B-cell lymphoma. At the end of March, the company received Orphan Drug Designation on IMO-8400 for the potential treatment of diffuse large B-cell lymphoma. 

Overall, Idera’s leadership and technology, give this company massive upside potential. Idera’s is a formidable pick for investors who are looking to invest in rare diseases and solid technology.

Tom Shaughnessy 

Source:http://www.benzinga.com/general/biotech/16/10/8516671/three-biotech-companies-with-large-upside-potential

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Week Ahead: One Pre-Sold Biotech IPO During A Short Holiday Week

Corvus Pharmaceuticals is the only IPO on the calendar during the shortened holiday week.

Since reaching a year-to-date low on February 11, the S&P 500 has gained 12%, while the market cap-weighted Renaissance IPO Index has surged 19%. The VIX Volatility Index has fallen to about 14, its lowest point since August 2015, and its third week in a row comfortably below 20. Among all 2015 IPOs, 74% trade below issue - an improvement over February (~80%) but still a drag on new issuance.

The year's seven IPOs, all biotechs or small health care deals, have an average return of 20%, largely due to Editas Medicine's (NASDAQ:EDIT) 84% gain. Their strong performance serves as a weak signal for an open IPO market, given the substantial support these deals have received from insiders. Corvus has similar support.

Could this combination therapy unlock the cure for cancer?

Corvus Pharmaceuticals (Pending:CRVS) expects to raise $75 million in the week ahead, below its original deal size of $115 million. The biotech is led by the executives behind blockbuster cancer drug Imbruvica at Pharmacyclics, which was sold to AbbVie (NYSE:ABBV) for $21 billion. Developing immune checkpoint inhibitors, Corvus targets an area of intense focus by large pharmas and biotechs alike (see last IPO, Syndax Pharmaceuticals(NASDAQ:SNDX)). Corvus last raised $75 million in September 2015, and insiders plan to purchase up to 33% of the IPO; crossover investors like BlackRock and Cormorant could help support the deal further.

Renaissance Capital's IPO Calendar - Week of 3/21/2016
Issuer Business	Symbol Exchange	Deal Size $mil	Price Range Shares Filed	Top two bookrunners
Corvus Pharmaceuticals Washington, DC	CRVS Nasdaq	$75	$15 - $17 4,700,000	Credit Suisse Cowen & Company
Developing checkpoint inhibitors to treat solid tumors.

The 1Q '16 will have the lowest IPO proceeds raised in over 20 years

IPOs rarely launch during holiday weeks, so we have a likely picture of the final 1Q '16 IPO deal flow. The quarter will end with less than 10 IPOs, the lowest number since 2009. It will be the first quarter in over 20 years without a non-healthcare IPO. Assuming Corvus raises $75 million, the quarter's eight healthcare IPOs (mostly biotechs) will have raised $672 million, the lowest sum in over 20 years - even less than the 1Q '09, when just one company (Mead Johnson (NYSE:MJN)) priced a $720 million offering. Additionally, the actual IPO proceeds provided by public investors this quarter will be far less due to widespread insider buying. That said, stable market conditions at the end of the quarter should bode well for an active 2Q.

IPO Market Snapshot

The Renaissance IPO Indices are market cap weighted baskets of newly public companies. The Renaissance IPO Index is down 9% year-to-date, compared to +0.3% for the S&P 500. Renaissance Capital's IPO ETF (NYSE: IPO) tracks the index, and top ETF holdings include Synchrony Financial (NYSE:SYF), Alibaba (NYSE:BABA) and Citizens Financial Group (NYSE:CFG). The Renaissance International IPO Index is down 4% year to date, compared to 0% for ACWX. Renaissance Capital's International IPO ETF (NYSE: IPOS) tracks the index, and top ETF Holdings include NN Group and Recruit Holdings.

By Renaissance Capital IPO Research 

Source:http://seekingalpha.com/article/3959714-week-ahead-one-pre-sold-biotech-ipo-short-holiday-week

It's time to buy biotech—here's why: Trader

Traders have hammered biotech stocks, with the IBB, the iShares ETF that tracks the sector, losing 5 percent in the last two sessions. But rather than run from the selling, one trader who relies heavily on the charts is diving in. According to Andrew Keene of Keene on the Market, the IBB had found "support" at its current levels. Looking at both a weekly and a daily chart of the biotech index, Keene noted that the IBB has responded particularly well when it has touched its 50-day moving average. "We saw buyers back in April," said Keene, referring to the 50-day average, which comes into play at around $348. "And we saw buyers in February and December," when the index also touched that key technical level. Keene also said that the IBB hasn't touched its 100-day moving average since last October. With the IBB above both its 50- and hundred-day moving average at $350, Keene's plan is simple. "Buy the pullbacks—any pullbacks whatsoever," said Keene. "This stock, on the daily chart and on the weekly chart, it lines up for buy opportunity." Of course, with the IBB up 14 percent, and 55 percent over the past year, shares of the volatile IBB are not cheap. So Keene is instead looking to the options market as a way to make a cheaper play. But rather than buy options, Keene is looking to take advantage of inflated prices for puts, so he is selling what is called a "bull put spread." In this structure, Keene is looking to sell a put just below where the IBB is trading and then buy an even lower strike put to protect himself in case the IBB tanks. In exchange for selling the puts, Keene is pocketing $350, but in order for him to keep all that money, he needs the IBB to stay above the strike of the put that he sold, or in this case, above $340. With the money collected, Keene says he has found a way to make a high probability bet on a fast moving sector. "I make money if the stock is flat, goes higher, or it can sell off about another $12 and I can still be profitable. Maxwell Meyers Source: http://www.cnbc.com