Oncolytics Biotech, Inc. (USA) (NASDAQ:ONCY)

CAPS Rating: 1 out of 5

A development stage company focuses on the discovery and development of oncolytic viruses for the treatment of cancers.

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Member Avatar bobfarr (< 20) Submitted: 3/11/2015 8:40:24 AM : Outperform Start Price: $0.79 ONCY Score: +0.25

On the cutting edge of cancer fighting viruses.

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Member Avatar zzlangerhans (99.81) Submitted: 2/21/2015 8:59:37 PM : Underperform Start Price: $0.71 ONCY Score: -14.21

For a microcap biopharma, it is extraordinarily difficult to keep track of Oncolytics' clinical trials. The company seems to choose which ongoing trials to discuss in quarterly updates out of a hat. When they do provide data, management is always pleased with the results but there's never a clear win.

A classic example of the way Oncolytics presents trial data is as follows, regarding the final data from the REO 018 trial of Reolysin in head and neck cancer:

"In April 2014, Oncolytics announced detailed results from the study. One hundred and eighteen patients had loco-regional disease, with or without distal metastases. Under the study conditions, test arm patients with loco-regional disease demonstrated a progression-free survival (PFS) benefit over control arm patients through five cycles of therapy. An intent-to-treat analysis of this study population showed a statistically significant improvement in PFS for the test arm versus the control arm (p=0.0072, hazard ratio=0.5360) using Type II censoring from the median PFS in each arm (48 days in the control arm and 95 days in the test arm). An intent-to-treat analysis of the patients with loco-regional disease to the median PFS in each arm also demonstrated a statistically significant improvement in overall survival (OS) for the test arm versus the control arm (p=0.0146, hazard ratio=0.5099), censoring any patients who received post-discontinuation therapy at the date on which they commenced the first of these therapies. The 118 patients with loco-regional disease, with or without distal metastases, were evaluated for percentage magnitude of tumour shrinkage at the first post-treatment scan (performed at approximately six weeks). The test arm showed a statistical trend towards increased tumour shrinkage over the control arm (p=0.076)."

Despite the obvious requirement for a PhD in statistics to even understand what the company is trying to say, it seems clear there are numerous red flags impugning the data. The overall patient population was split into separate groups of patients with and without locoregional disease halfway through the trial. The company presents an "ITT analysis" that conveniently excludes the subgroup with only metastatic disease. The company presents both PFS and OS data of the ITT group with certain patients censored from analysis, which by definition means they did not conduct an ITT analysis. In case there's any doubt over whether the company thinks REO 018 succeeded in a way that could convince the FDA to approve Reolysin for head and neck cancer, we get this nugget a little later on:

"Oncolytics intends to treat the REO 018 clinical trial as a separate supportive study to a planned randomized, follow-on international Phase III registration study of REOLYSIN® in head and neck cancer patients."

In other words, a do over. REO 018 won't be considered a registrational trial for any hypothetical NDA for Reolysin. Oncolytics hasn't provided any guidance that I'm aware of as to when we can expect them to start a new phase III trial in head and neck cancer. Never fear, however. Oncolytics has also tested Reolysin in metatstatic sarcoma, metastatic melanoma, ovarian cancer, pancreatic cancer, colon cancer, and NSCLC. All of these phase I and phase II clinical trials have produced encouraging interim data, according to management, but the last quarterly PR makes no mention of any plans for registrational trials of Reolysin in any indication.

I've never been able to establish a correlation between Oncolytics' share price and the current state of their trials. The stock has been volatile, but the magnitude and direction of the moves has often caught me wrongfooted. In October the share price dropped to a multiyear low of 0.40, ripped up to 1 a couple of weeks later, and then gradually declined back to 0.4 before climbing back up to 0.75 amidst a blizzard of Reolysin Orphan Drug PR's. Could Oncolytics cruise back to 2, or 4, or 6? Sure it could, and anyone who says otherwise hasn't followed biocrap. But I think this is more likely to be a false breakout for several reasons:

1. Orphan Drug status means very little for a drug that hasn't even gotten to phase III. It says next to nothing about the drug itself, but rather describes the rareness of the indication. No implications regarding efficacy or approvability. Like Fast Track and probably BTD, it's just another false catalyst that gives momo traders a handhold but is forgotten once the momentum dies.

2. Tons of biocrap is shooting up this month. Mela and Cel-Sci, for God's sake. Apricus. Vermilion. Cyclacel. I don't think this has anything to do with fundamental value.

3. The five year chart shows a series of spikes declining in amplitude. If the pattern holds, we've already seen the highs here. The momos are getting bored with this toy.

I'm not crazy enough to short a stock like Oncolytics, which could pull massaged interim data from some half-forgotten open label phase II trial out of their butts at any time. On the other hand, it's fun to give a company like this a sharp kick in the teeth every once in a while.

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Member Avatar 78taxs (< 20) Submitted: 2/21/2015 8:45:37 PM : Outperform Start Price: $0.67 ONCY Score: +21.23

Cancer help. I'm for it.

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Member Avatar retireatwork (< 20) Submitted: 9/4/2013 4:24:24 PM : Outperform Start Price: $2.69 ONCY Score: -96.40

Phase 3 results pending that will almost certainly be positive. If they avoid certain pitfalls related to execution, their product could become very widely used in oncology in a relatively short period of time.

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Member Avatar checkup13 (< 20) Submitted: 6/25/2013 1:53:45 PM : Outperform Start Price: $2.66 ONCY Score: -102.08

Phase III results are imminent and interest from big pharma would likely follow. Very exciting treatment potential.

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Member Avatar drjanet (< 20) Submitted: 3/28/2013 10:40:58 AM : Outperform Start Price: $3.20 ONCY Score: -108.86

This biotech could change the face of cancer worldwide.

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Member Avatar DKERST (< 20) Submitted: 12/13/2012 7:58:14 PM : Outperform Start Price: $3.06 ONCY Score: -120.95

ONCY is a long term hold of mine - 12 years.
It is not over until the fat lady sings, but the fat lady is smiling today. Do your own research - the ONCY web site is very informative. Also check out the TED talk by Patrick Lee on the web. The MF recently (aprox.three days ago) published a rather uniformed article on this stock. Enough said.

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Member Avatar fresnarus (< 20) Submitted: 8/22/2012 6:28:45 PM : Outperform Start Price: $3.03 ONCY Score: -121.57

Oncolytics is a development-stage biotech company. It's single product under development is Reolysin, a virus that has been demonstrated to selectively reproduce in cancer cells with an activated RAS pathway. Around 1/3 of primary tumors and 2/3 of metastatic tumors have an activate RAS pathway, so there is a considerable market for this drug should it eventually win approval from the FDA.

The company has an impressive collection of ongoing and completed clinical trials. Furthermore, the National Cancer Institute (NCI) in the USA and the National Cancer Institute of Canada (NCIC) have been sufficiently impressed that they are conducting research at their expense on the company's behalf. The external funding for these studies is roughy $45M, a number that can't be sneezed at given that ONCY currently has a market cap of $250M. The NCIC has announced that it will conduct randomized controlled trials in breast, Lung, colorectal, and prostate cancer. The NCI is conducting trials in multiple myeloma, pancreatic, and ovarian cancer. A successful result in any one of these indications would more than justify the current market valuation.

Furthermore, the company is currently involved in a phase III trial for head and neck cancer. Time will only tell what the result of this trial will be, but all previous results have been quite positive.

The company is currently oversold, as of August 2012, with roughly 45-days worth of trading volume worth of short interest. Should the phase 3 head and neck trial report positive results the shorts will be in real trouble trying to cover their positions with so much short interest.

There is not much more to say, but for everyone's health we should all wish for a positive outcome. It is worth mentioning that roughly 1/2 of men and 1/3 of women will develop cancer in their lifetimes. With 7B people in the world, this company has the potential to be a true benefit to mankind.

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Member Avatar ryebakerboy (< 20) Submitted: 8/8/2012 10:40:39 AM : Outperform Start Price: $2.86 ONCY Score: -121.47

I believe the PHIII trial has a high likelihood of success, in which case the stock will take off given the high number of cancer indications reosylin is applicable to

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Member Avatar NeutralNick (< 20) Submitted: 1/30/2012 6:08:18 PM : Outperform Start Price: $4.61 ONCY Score: -141.34

The Reolysin product appears to actually work, isn't very toxic, has a novel mechanism of action, and is synergistic with other cancer chemotherapy treatments. I expect it to become a standard component of most chemotherapy regimens. Also, once Reolysin gets approved, the real strength of this company will become evident: they have developed unique expertise in this drug class that will give them an advantage over those in big pharma who decide to play catchup. It seems likely that a company like Abbott or Lilly would scoop them up.

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Member Avatar camelcoat43 (< 20) Submitted: 1/11/2011 9:52:41 AM : Outperform Start Price: $6.25 ONCY Score: -151.83

Clinical trials show control of cancer in 65-75% of patients and control of 95% of metastatic cancers. Reolysin has only trivial side effects. Check www.clinicaltrials.gov REOLYSIN for current clinical trials sponsored by NCI, UK, Univ. of Texas and others. Solid patent protection in place, including coverage for manufacturing process.

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Member Avatar mrnot (< 20) Submitted: 12/9/2010 4:35:22 PM : Outperform Start Price: $6.10 ONCY Score: -155.71

Have been following for several months. These guys are on to something

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Member Avatar jennings2 (< 20) Submitted: 12/2/2010 3:37:20 PM : Outperform Start Price: $4.96 ONCY Score: -154.90

Oncolytics is a speculative play, no doubt. No completed Ph3 yet. It has one drug. A small cap with little cash. So why buy. Simple. Risk reward.

ONCY is trying to cure cancer, as are many. What differentiates it, is it's one drug's mechanism of action, if proven successful, will work against many common cancer indications. That gives it a big revenue potential relative to current market cap. The side effect profile is minimal and generally well understood. The virus itself is well known scientifically and generally benign in humans. The drug (a virus) has proven in early trials to be capable of dramatic outcomes. Since it works synergistically with chemotherapy, trials are easy to design and set up. Give standard of care and standard of care plus Reosylin. If it is proven to work in one indication, stock price will appreciate significantly from current levels. Given that there are many indications entering trials recently, with gov't and health institute support, those in the research community must see some possibility of success. So if you are willing to invest in what are very risky biotech companies, this company is not a bad choice, as they are focussed on one thing, Reosylin, that if successful, could used in conjunction with standard of care across many different cancers.

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Member Avatar bridger48 (< 20) Submitted: 10/4/2010 10:57:07 PM : Outperform Start Price: $4.93 ONCY Score: -166.31

Something like 64% of drugs that reach this level are eventually approved. Looking at the size of the ongoing PIII that is expected to be only 280 patients is interesting. The smallness is a real in your face we can show the FDA statically significance in just 280 patients. However ONCY management is saying they really expect statically significance numbers at just 80 patients and only need the other 200 for a more complete safety package even when the normal side effects are simple flu like, lookout chemo.

Future financing looks to be put off till sometime next year. Recent comments by the company CEO they have several options available and are being looked at. With only about year + of cash on hand and delayed financing it appears the company believes upcoming PII results will worth the wait. Still I can not completely discount some sort of small bridge financing or forced warrant conversion should the PPS reach $6.50 US prior to ASCO 2011. ONCY is something to be watched closely in the coming months.

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Member Avatar seawayguy (< 20) Submitted: 8/20/2010 8:43:47 AM : Outperform Start Price: $3.14 ONCY Score: -169.25

Numerous phase 3 trials underway. They were unable to complete a phase 2 because patients "lived too long". April press release indicates they can "cure" cancer in mice. Looks and photographs of recent results from post presentation speaks for itself. This will be a ten dollar stock as trials near completion and 20 plus with the results.

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Member Avatar edward1517 (< 20) Submitted: 5/30/2010 1:52:25 AM : Outperform Start Price: $3.03 ONCY Score: -166.89

They have a solid product in Resolyn and in stage 3
in 2 trials.A patnership should be forthcoming shortly

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Member Avatar akeagle52 (< 20) Submitted: 2/9/2010 7:53:32 AM : Outperform Start Price: $2.95 ONCY Score: -168.37

Oncy appears to be well managed, the research is solid, and there are a core group of individuals who believe in ultimate success. Key investors believe enough to back their beleif with dollars. Large drug companies are watching close with keen interest. A successful product will cause a stamped of offers to buy and the stock to soar. The risk is reasonable and the price is right. I'll invest and wait 5 years. sf

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Member Avatar 20PercentPM (< 20) Submitted: 10/4/2009 7:04:59 AM : Outperform Start Price: $3.37 ONCY Score: -179.84

Dr. Brad Thompson, President and CEO said last week "Oncolytics is the first company to reach an agreement with the FDA on a Phase 3 trial design for an intravenously-administered oncolytic virus under the SPA process," Now I’m not a scientist but that sounds like a major accomplishment to me. A positive outcome could lead to a license application for REOLYSIN, which is the Company’s potential cancer therapeutic. Needless to say the profit potential for a successful treatment would be enormous.

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Member Avatar lallfamily (< 20) Submitted: 10/1/2009 11:19:22 PM : Outperform Start Price: $3.24 ONCY Score: -180.65

The stock has many trials in progress for its only product "Reolysin". Its very close to approval of a phase III FDA trial. A conference call on it phase III is scheduled for 8:30 am EDT tomorrow. After hours up 30%. Its one of the few times you will see a stock with so much potential so cheap.

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Member Avatar jeffln74 (< 20) Submitted: 8/27/2009 2:16:37 PM : Outperform Start Price: $2.20 ONCY Score: -167.47

It's very difficult to get to stage 2. Within the next 6 months to a year this drug will be in stage 3. At that point this stock will take off. Likely it'll be bought out by a big name drug company.

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