Telesta Therapeutics (BNHLF)

[JosephLet]

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...%20Meeting.pdf (http://www.bioniche.com/pdf/2014/CEO%20Presentation%202014%20Annual%20General%20Mee ting.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

[ktcujshz05]

Bioniche Life Sciences Receives Coverage as Highly Undervalued Biopharmaceutical ...
http://finance.yahoo.com/news/bionic...141921899.html (http://finance.yahoo.com/news/bioniche-life-sciences-receives-coverage-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."

[JuanitaHina]

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



http://finance.yahoo.com/echarts?s=BNHLF+Interactive#{%22range%22%3A%221mo% 22%2C%22scale%22%3A%22linear%22}


"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."

[Kelli2239]

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

[LovworNes]

New Analyst Rating

Im sure that we will see higher share price than the PT below of $1.25 before FDA decision .GL

Market Cap: $42 Million

Price:0.25

We (Euro Pacific Capital) are initiating coverage on Telesta Therapeutics (formerly Bioniche Life Sciences) with a Speculative BUY rating and one-year target price of $1.25. The firm’s lead non-muscle invasive bladder cancer biologic MCNA already performed well in Phase III testing, well enough to be FDA approved by next year in our view, and our model is primarily derived from free cash flow projections in global markets for this imminently partnerable (and acquirable) clinical asset. Investment Highlights Attractive oncology drug developer for which already-published Phase III data mitigates clinical risk .