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Old 07-25-2014, 09:42 AM   Nav to Top  #1
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Default BNC.TO (MC $42 M)(Cash $12 M) Approval For Bladder Cancer Drug soon

BNC.TO ..Very BIG BIG Surprise for the Company because of the fantastic News from FDA on last Friday . FDA says they can File for Marketing Approval just based on Bioniche's existing clinical trial data set. Management itself thought they need to conduct another Phase 3 Study .

The Drug called MCNA for Bladder Cancer has HUGE Market Potential and it could be on the Market within 1H 2015 if it gets Priority Review .The Market Cap of $42 Million is really a Big Joke and the key point is that not many people have this pure Goldmine on their Radar .

Bioniche is already in discussions with Potential Partner means we can expect nice upfront payments i think $25-40 M is realistic .

Bioniche is definitely one of the cheapest Cancer Play i ever have seen before .GL



Bioniche Life Science (BNC.TO)

Market Cap: $42 M
Cash: $12.2 M
Price: $0.29


Bioniche Announces Intention to File for Marketing Approval of MCNA in the United States (July 18)
Bioniche Announces Intention to File for Marketing Approval of MCNA in the United States - Yahoo Finance



Presentation from June
http://www.bioniche.com/pdf/2014/Bio...une%202014.pdf



From latest Earnings (May 2014)
Bioniche Life Sciences Inc. Reports Fiscal 2014 Third Quarter Results - Yahoo Finance
the Company has approximately $12.2 million in cash and cash equivalents. This represents approximately 14 months of operations for the Company, based upon including the first escrow payment of $0.6 million and the anticipated positive working capital adjustment of $2.4 million from Vétoquinol."
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Old 07-29-2014, 10:47 AM   Nav to Top  #2
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More good News for BNC.TO and nice move to 0.37 but still massivly undervalued .

Bioniche Announces Submission of Orphan Drug Designation Application for MCNA in the United States
Bioniche Announces Submission of Orphan Drug Designation Application for MCNA in the United States - Yahoo Finance
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Old 09-15-2014, 11:12 AM   Nav to Top  #3
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The ongoing Share Offering which will end this Week created a Fantastic Buying opportunity ...The Bladder Cancer vaccine could be on the Market in 2H 2015 so i think a Price target of $2 within 12 Months is very realistic. GL


Here are the new numbers which includes the current Share offering :

Bioniche Life Science (BNC.TO)

Market Cap $40 M
Cash $15 M
Price $0.22



Bioniche Announces Q1/2015 Timeline for the Filing of a Biologics License Application for Marketing Approval of MCNA in the United States..
Bioniche Announces Q1/2015 Timeline for the Filing of a Biologics License Application for Marketing Approval of MCNA in the United States - Yahoo Finance


Market Potential

The Company has conducted an internal assessment of the potential available patients in the U.S. on a yearly basis, using a watershed/stratification of published NMIBC epidemiology data and guidance from urologists experienced in the treatment of the disease. Based on internal analyses, the Company projects that there are approximately 8,500 new available patients in the U.S. each year. Based on these patient number assumptions, and making certain estimates of drug pricing, unit volume and market penetration rates, the Company estimates that in the U.S. the market potential for MCNA in BCG-failures could approach $200 million per year.
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Old 03-05-2015, 09:11 AM   Nav to Top  #4
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New Analyst Rating

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

Telesta Therapeutics (TST.TO ) ( OTC:BNHLF)

Market Cap: $52 Million
Price:0.32


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.
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Old 03-05-2015, 09:14 AM   Nav to Top  #5
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One of the Cheapest Cancer Play out there with a ridiculous Market Cap of $52 Million a real 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."
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Old 03-30-2015, 12:09 PM   Nav to Top  #6
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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 - Telesta Therapeutics

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.
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Old 05-05-2015, 09:24 AM   Nav to Top  #7
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Market Cap of C$54 Million is a Big Joke for this undiscovered gem .


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
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Old 11-02-2015, 10:28 AM   Nav to Top  #8
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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

Marketcap $160 Million
Cash $45 Million

Price: 0.57



Telesta Therapeutics: Near-Term Catalyst Could Provide Multi-Bagger Returns
Telesta Therapeutics: Near-Term Catalyst Could Provide Multi-Bagger Returns - John H. Ford | Seeking Alpha


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.
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