BNHLF (MC $33 M) BLA Filing for BIG Bladder Cancer vaccine in this Quarter =500%+ Potential

BNHLF (MC $33 M) BLA Filing for BIG Bladder Cancer vaccine in this Quarter .

Runup to FDA decision and Approval could drive this Stock close or over $2 per Share ! GL


Market Cap: $33 Million
Cash: $10 Million

Price: $0.19


Presention fron last month
http://www.bioniche.com/pdf/2014/CEO Presentation 2014 Annual General Meeting.pdf


Bioniche will file BLA with the US FDA, seeking approval for the commercialization of MCNA based on existing clinical data; Target filing date: Q1/2015 . Near term revenue opportunity in the U.S
Potential for marketing approval as early as end of 2015/early 2016 .Exploring potential for US listing .

Pivotal phase 3 study (completed) shows it can delay (or prevent) need for cystectomy (bladder removal) in 25% of patients with high-risk non-muscle invasive bladder cancer (NMIBC) who failed first line BCG treatment

Supported by strong intellectual property coverage
•Patent term expiration: 2031
•Automatic 12 year market exclusivity for novel biologic in US

Of all cancers, bladder cancer has the greatest lifetime treatment cost per patient diagnosed (US, 2010)
$230,000 . 80,000 new cases/year in North America .

Potential for peak U.S. sales of $200M plus .Comparable or greater market opportunity ex-US

•NMIBC BCG-failure population only
•50% market penetration
•$3,000 per dose

Bioniche Life Sciences Receives Coverage as Highly Undervalued Biopharmaceutical ...
http://finance.yahoo.com/news/bionic...141921899.html


Bioniche is not only expected to apply for market approval in Q1 2015, but it has already submitted an application to the FDA for Orphan Drug Designation which would give Bioniche 7 years of market exclusivity in the US.

While this company has been well under the radar, Lahiri says, "Odds are Bioniche will obtain an Orphan Drug Designation soon and FDA market approval by next year, enabling them to capture a sizeable market share in the $1 billion addressable bladder cancer market."

Hits 4 month high and still brutal undervalued with a Market Capof $40 Million.


http://finance.yahoo.com/echarts?s=BNHLF+Interactive#{"range":"1mo","scale" :"linear"}


"Telesta is a late stage therapeutics company with near term commercial potential focused on a unique specialty drug (MCNA) for non-muscle invasive bladder cancer. The drug has completed a phase III study and the Company expects to file its biologics license application (BLA) with the FDA in Q1 of 2015.

During 2014 there were 74,690 new cases (15,580 deaths) of bladder cancer in the United States with 70%-80% of these being non-muscle invasive. There has not been a new treatment for this type of cancer approved by the FDA since 1998. With greatest lifetime treatment cost per diagnosed patient currently at $230,000, the approval of MCNA by the FDA creates a significant opportunity for the Company. MCNA addresses an unmet medical need as it could be an alternative to radical cystectomy for patients.

The US FDA has reviewed the Company's clinical data and is supportive of a BLA filing with no additional trials. MCNA is a high margin biologic opportunity for Telesta that will be priced as a premium oncology product. The market size has been validated by an independent 3rd party and this market is significant.

The Company has very strong intellectual property coverage allowing for market exclusivity potential to 2031."

Still one of the Cheapest Cancer Play out there with a ridiculous Market Cap of $41 Million a lifetime opportunity here .GL


Presentation February

http://www.telestatherapeutics.com/cms/phpP7aOHe.pdf


Summary

•Under-the-radar Canadian public company with little/no exposure to
U.S./Institutional investors

US BLA submission targeted for Q2/2015 – potential approval in Q1/2016
•De-risked through significant interaction with US FDA <<<<<<<<<<<<<<

US peak market estimate $400 million with comparable market opportunity ex-US

New and focused senior management team and board has transformed the
company

•Unencumbered, late stage, near-commercial uro-oncology asset
•Very favourable specialty pharma product profile
•Patent protection potential to 2031
•Strong competitive position – no late stage competition
•Significant 3rd party interest in this asset


The Company also reported that there is significant 3rd party interest in the MCNA program and that it is in receipt of multiple non-binding expressions of interest from a variety of public and private pharmaceutical and biotechnology companies. Due to the confidential nature of the ongoing discussions, Telesta will only provide further updates to shareholders upon signature of a binding agreement.

Dr. Michael Berendt, CEO & Chief Scientist of Telesta cautioned that: "We will fully evaluate and negotiate the current offers to ensure that if we take the decision to partner MCNA or sell the company at this juncture, that such a decision will capture significant value for our investors."