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

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 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."

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."

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 .


We value Telesta using the average of three methods as shown in Exhibit 16; an NPV determination based on our 10-year MCNA-derived free cash flow projections, 20x multiple of our F2019 EPS forecast, and 12.5x EV/EBITDA multiple, with all methods discounted by 30%, a rate that is if anything conservative for a clinical asset for which clinical risk has already been greatly attenuated by already-published Phase III data. As we indicated above, we forecast fully-diluted, fully-taxed EPS of $0.15 and adjusted EBITDA of $54.6M in our F2019 reference year. From the average of the three methods, we derive a $1.38 price target, which we conservatively round down to $1.25.

Stock is close to new 52W high and its still brutally undervalued with a Market Cap of around C$63 Million (= US$49.6 Million ) .GL


Telesta Therapeutics – (TST on TSX)

Presentation Time - Wednesday April 1st – 11:40 AM ET

Website - http://telestatherapeutics.com

Current Market Cap – Approx. $63 M

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 it biologics application license (BLA) with the FDA in Q2 of 2015.

Additional Highlights

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 with a patent term that would expire in 2031 along with secondary protection of 12 years with US market exclusivity for novel biologic.

There has not been a new treatment for this type of cancer approved by the FDA since 1998.

Market Cap of $42 Million is a Big Joke for this undiscovered gem .

New Presentation
http://telestatherapeutics.com/cms/phpQN6vsA.pdf

Investment Opportunity

•New management team has led transformative change

•Investor Relations effort to introduce Telesta
to U.S./Institutional investors

•Focused on MCNA, an unencumbered, late stage, near-commercial asset
for bladder cancer

•BLA filing targeted in Q2/2015 with potential US approval as early as Q2/2016

•Significant dialogue with US FDA to minimize regulatory risk

•3rd party assessment of U.S. market opportunity, market access and pricing

•MCNA specialty product profile validated by strong partnering interest

•Multiple valuation enhancement milestones in short and medium term


MCNA – Specialty Product Profile

• Near term revenue opportunity in the U.S

•Potential for marketing approval as early as Q2/2016 with long patent
term and statutory protection

•Specialty uro-oncology product – promotion to urologists

•Requiring small specialty sales force to target key subset of urologists

•Product fits into current urology practice

•Lack of viable treatment options for patients and physicians

•Target Product Profile very well received by urologists

•Opportunity for targeted medical education and patient advocacy

•Potential for novel oncology product premium pricing with favorable
market access environment

•Strong competitive position – no late stage competition and strong IP


Telesta Opportunity

•Under-the-radar Canadian public company - just
beginning to raise profile with U.S./Institutional investors
after major transformation

•Unencumbered, late stage, pre-commercial
uro-oncology asset with “perfect” specialty product profile

•BLA submission targeted for Q2/2015

•De-risked through significant interaction with US FDA

•Potential for marketing approval in 2016

•Multiple exit and value creation opportunities

Billion Dollar Cancer Drug close to FDA approval if approved then this Stock could be a 10 Bagger .GL


ADCOM on November 18

FDA Decision in 1Q 2016


Telesta Therapeutics (BNHLF) (TST.TO)

Marketcap$115 Million
Cash $45 Million

Price: 0.40



Telesta Therapeutics: Near-Term Catalyst Could Provide Multi-Bagger Returns
http://seekingalpha.com/instablog/59...bagger-returns


Valuation summary (all share prices in US dollars)

· Fair valuation today: $300 million. Shareprice: $1.04.

· Fair valuation following positive advisory committee recommendation: $600 million. Shareprice: $2.08.

· Fair valuation following 2nd Phase 3 trial recommendation: $150 million. Shareprice: $.52.

· For valuation following 2nd phase 3 trial recommendation with concurrent FDA approved drug sales: valuation $400 million. Shareprice: $1.38.

· Fair valuation following FDA approval: $1 billion. Shareprice: $3.47.

· Fair valuation long-term following FDA approval: $3 billion to $4.5 billion. Shareprice: $10.41 to $15.62.

Telesta is currently trading in the $.30 range in the US, so any of the above scenarios would provide significant returns. The only caveat, is that if a 2nd phase 3 trial is recommended, the company could trade well under fair valuation for a period of time.



Telesta provides 3 opportunities that could generate short-term multi-bagger returns:

· Telesta is so undervalued that with any level of Wall Street awareness, the share price could be driven higher. As we get closer to November 18, the shareprice could rise in anticipation of a positive recommendation.

· When the company reports the results of the FDA's advisory committee, if the results are positive, the share price should rise again.

· In February we will learn whether or not the FDA has approved Telesta's lead drug. With FDA approval, Telesta should be worth at least $1 billion and I would expect buyout offers in that range.

FDA precedent has already been established with Valstar's approval, and I believe MCNA with its superior clinical results will be approved in February. In effect, this is an opportunity to buy a soon to be $1 billion company, for $90 million, a true Buffett trade.