Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
"When a Major Pharma like Merck ( with Keytruda) links up with a growth new Pharma like OncoSec, the message couldn't be clearer."
Come on. Then I guess the message couldn't be more clear for the other 60+ entities that Merck has "linked up with" as well right? I am an ONCS shareholder and think they have great potential in the future, but the misrepresentation of the current situation is ridiculous. This seems to be a reoccurring theme on a few message boards.
lasers,
For PD to keep the investment community in the dark? Keep them in the dark about what? That Merck is simply supplying Keytruda for the P2b combo trial and that any further relationship is contingent on how the trial pans out?
There is nothing else for him to say. If people would start to understand that they would not feel the need to project negative reactions. ONCS is nothing to Merck at the moment. Those who realize that have a totally different patience level with this stock.
JHam
Also, I am not really sold on this author knowing exactly what he is talking about. With comments like these:
"A successful ALS drug must show effects over a year or more so that short term results must be viewed with caution."
Where is he getting that? That is not true. So far the data on NurOwn suggests that the effects wear off after about 3 months or so, so they'll need to re-dose 3 or 4 times a year. That doesn't mean it isn't successful.
"Recently there have been two large trials in ALS involving Biogen’s dexpramipexole and Cytokinetic’s tirasemtiv. Neither drug was successful in showing a statistically significant improvement in ALSFRS-r in large randomized trials involving several hundred patients. Hence a statistically significant improvement in a 12 patient randomized trial would be stunning."
I think this is a meaningless statement. It wouldn't be stunning if the drug actually worked. Biogen and Cytokinetic's drug failed because it just didn't work. Especially if you are working with stem cells like BCLI and CUR, where you can't tell the cells not to do their job from the beginning.
I do agree with the points about not showing placebo results and that making this data difficult to interpret clearly. Why have a placebo arm if you aren't going to compare those who were treated with it? It brings the entirety of the data into question in my opinion.
Then there is this from today. Market study results for WF10. Highlighted parts are mine:
http://www.prnewswire.com/news-releases/nuvo-research-completes-wf10-us-market-study-for-treatment-of-refractory-allergies-280027142.html
Nuvo Research® Completes WF10™ U.S. Market Study for Treatment of Refractory Allergies
MISSISSAUGA, ON, Oct. 22, 2014 /PRNewswire/ - Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced the results of a market study commissioned to investigate the U.S. opportunity for the Company's experimental immunotherapy product, WF10, as a treatment for patients with refractory allergic rhinitis. The study, performed by Psscion Lifesciences Consulting (Psscion), forecasts that WF10 could capture 10-15% of the U.S. refractory allergic rhinitis market with peak U.S. annual sales of US$0.7 billion to US$1.1 billion.
"This market study confirms the significant U.S. market opportunity for WF10 to treat refractory allergic rhinitis," said Dr. Henrich Guntermann, President of Nuvo's Europe & Immunology Group. "Our clinical and case study data suggests that WF10 is a revolutionary therapy that provides symptomatic relief from multiple airborne allergens for up to 2 years after only 5 days of treatment. We are eagerly awaiting results in Q1 2015 of our ongoing 183 patient Phase 2 allergic rhinitis clinical study that is designed to confirm the positive results achieved in our earlier 60 patient Phase 2 proof-of-concept study."
About The Psscion Study
The market study was conducted by Psscion, a U.S. based firm that provides strategic advice and market research to the pharmaceutical industry. Psscion was retained to assist Nuvo in determining the optimum strategy to maximize the value of WF10 for the treatment of refractory allergic rhinitis. In the course of the study, Psscion interviewed patients with refractory allergic rhinitis, practicing physicians specializing as allergists and immunologists and representatives from insurance companies and other payers. The additional findings in the study were:
Physicians were impressed by WF10's efficacy, long-lasting therapeutic effect, ability to treat multiple allergens with one dosing regimen and favourable safety profile as observed in the Company's completed 60 patient Phase 2 proof-of-concept study and case studies;
Patients and physicians believe that WF10 would address an unmet need in the treatment of refractory allergic rhinitis;
WF10 could be an attractive alternative to subcutaneous immunotherapy (SCIT) also known as "allergy shots" which are allergen specific and can continue for months or years causing many patients to either refuse or discontinue SCIT treatment; and
Payers rated WF10 positively and felt that WF10 was unlikely to face significant barriers to coverage.
About the Company's Ongoing WF10 Phase 2 Clinical Trial
This 16 week clinical trial is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of a regimen of five infusions of either WF10 or its main constituents (sodium chlorite and sodium chlorate) relative to saline control in allergic rhinitis patients experiencing persistence or recurrence of symptomatic episodes in spite of conventional treatment over the previous year. The trial will measure total nasal symptom score (TNSS) and other secondary endpoints. The trial is being conducted at 15 sites in Germany. It is fully enrolled with 183 patients participating. Top-line results are expected in Q1 2015. The trial is designed to confirm the results of the Company's 2010 60 patient, randomized, double-blind, placebo-controlled, single-center Phase 2 clinical study of WF10 for the treatment of allergic rhinitis which achieved statistical significance (P<0.001) for its primary endpoint (change in TNSS at week 3).
About Refractory Allergic Rhinitis
Allergic rhinitis, a highly prevalent condition characterized by nasal symptoms (runny, blocked, or itchy nose; chronic sneezing) is triggered by an inappropriate immune response to one or more allergens such as pollens, house dust mites and pet dander. Refractory allergic rhinitis patients often suffer from severe symptoms and do not respond adequately to common forms of treatment such as antihistamines and nasal corticosteroids. Most refractory allergic rhinitis patients suffer from multiple allergies.
About WF10
WF10 is a solution containing stabilized chlorite ions that focuses on supporting the immune system by targeting the macrophage, a type of white blood cell that coordinates much of the immune system, to regulate normal immune function. WF10 is an infusion therapy currently approved only in Thailand under the name IMMUNOKINE for the treatment of post-radiation-therapy syndrome.
I'll try to resurrect this board as lots of good news has started to flood in. After the sale of Pennsaid 2% to Horizon, NRIFF now has $67M in cash. Currently more cash per share than price per share:
http://searchingwallstreet.com/nriff-nuvo-research-sells-u-s-pennsaid-rights-to-horizon/
NRIFF: Nuvo Research Sells U.S. Pennsaid Rights To Horizon
October 20, 2014 admin Small Cap
By David Bautz, PhD & Jason Napodano, CFA
OTC:NRIFF
TSX:NRI.TO
On October 17, 2014 Nuvo Research (OTC:NRIFF) (TSX:NRI.TO) announced it completed the sale of the company’s Pennsaid 2% U.S. sales and marketing rights to Horizon Pharma (Nasdaq: HZNP) for a cash payment of $ 45 million (CAD$ 50 million). Horizon will begin commercialization of Pennsaid 2% on January 1, 2015. Nuvo continues to retain all rights to Pennsaid and Pennsaid 2% outside the U.S. and is intending to seek a marketing partner or partners for international territories.
As part of the agreement with Horizon, Nuvo will be the exclusive supplier of Pennsaid 2% to Horizon for the U.S. market. Based on the level of sales that Horizon is able to generate for Pennsaid 2%, there could be some additional upside to Nuvo through the manufacturing mark-up. In the past we have forecasted that Pennsaid 2% peak U.S. sales are roughly $ 50 million. We believe Nuvo’s manufacturing and supply agreement with Horizon equates to an additional low-single digit royalty on these sales at full scale.
This deal follows the announcement last month that Nuvo had settled the litigation with Mallinckrodt (NYSE: MNK) that included the return of all U.S. marketing and sales rights to Pennsaid and Pennsaid 2% along with a cash payment of $ 10 million USD. We believed that Nuvo would move quickly on licensing or selling the U.S. rights to Pennsaid 2% following the litigation settlement and had predicted that a deal was likely to bring in approximately $ 20-$ 30 million USD with royalties in the mid- to high-teens. Thus, our prediction was not too far from what Nuvo ended up with by selling the full rights unencumbered by royalties.
Nuvo exited the second quarter ending June 30, 2014 with $ 10.7 million CAD in the bank. We estimate burn for the third quarter 2014 was roughly $ 2.5 million CAD. Adding in the $ 10 million USD payment from Mallinckrodt and this new $ 45 million USD payment from Horizon, we now forecast that Nuvo is sitting on approximately $ 67 million CAD in cash.
We remind investors that Nuvo will be reporting top-line results from the Phase 2 clinical trial of WF10 for the treatment of allergic rhinitis in the first quarter of 2015. The large amount of cash that the company now has will aid in funding the company’s continued development of WF10, including further studies into WF10’s mechanism of action and dosing studies to determine the minimum effective dose. We provided investors a brief update on WF10 in August 2014.
Since our last Zacks Report on Nuvo on Sep. 16, 2014, the stock has risen close to 50%. Even so, we still believe the stock is undervalued as the company currently has close to $ 5.00 per share in cash. The next catalyst will be release of the Phase 2 data for WF10, with positive results likely to send the stock significantly higher. We are maintaining our ‘Buy’ rating and a $ 7.50 price target.
READ THE LATEST FULL RESEARCH REPORT HERE
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR and to view our disclaimer.
Thanks for posting. I don't think it was the SA article as much as it was the PR that went out:
http://www.businesswire.com/news/home/20141019005074/en/Genervon-Announces-ALS-PD-Phase-2a-Trial
The SA article was based on the PR.
Up over 9% in after hours trading. Back over $4.05...we'll see if it holds over to pre-market.
Minding,
First off, in response to your reply to my post about BCLI and CUR not being down because of the article, it sounds like you agree with me now that the selloff was due to the article. Not only BCLI and CUR, but other companies going after ALS took a hit as well on Monday.
Thanks for the post and quotes from your friend. He may have had a lot of success in the past, but with all due respect, he is incorrect and seems a bit misinformed on BCLI:
"BCLI is also taking some heat today in response to positive developments by other companies doing research on ALS. BCLI is only actively doing research on ALS although its technology may have other applications. (And there are a number of companies that are using stem cell tech to treat both Parkinson's and MS.) Anyone who is perceived to be ahead in the game will reduce speculation about BCLI being successful."
Not true. BCLI completed pre-clinical work for Parkinson's back in 2005, and should be close to completing (if they haven't already) their pre-clinical work for MS. Its potential application is the beauty of NurOwn and why I remain interested. Once they have proven safety and tolerability they'll likely not have to go through Phase I with other indications and be able start from a more pivotal trial, as it is the same treatment.
"I do not expect any catalysts to emerge for BCLI until next year when test results will be known."
What about BCLI's Phase 2a data that will be released before the end of this year? Why is that any less of a potential catalyst as Genervon's Phase 2a data release Monday? What results is your friend expecting next year?
"In medical tech its always about who gets to the goal line the quickest. If someone has a better mouse trap than the competition and it has to do with health care, people flock to the better trap until something better comes along. From an investing standpoint, the money will flow into the leaders in medical tech not the followers."
No one in their right mind will say that after a one-tailed pilot study done on 8 patients, that Genervon is the disputed leader. Just like there are dozens of headache medicines, there will be room for more than one player in this huge market of neurological degenerative diseases.
"With BCLI, they have not given any indication that their results are anywhere close to those reported today by a non-public company. The same can be said for CUR."
What kind of indication did Genervon give before the release of their Phase 2a data? We won't know until we see it published later this year, but again you can't compare one-tailed data to two-tailed data. Of course two-tailed will be lower than Genervon's because it is measuring both sides.
"[Genervon's] approach appears to be gene therapy, not stem cells"
Yes, and if Genervon can show that they have been able to get to the origin of what causes ALS, then that would be huge, as that has been the toughest nut to crack so far for anyone. They have not said that they have though.
"I will no longer touch CUR or BCLI, simply because neither have funding sources if something goes wrong."
Why is that suddenly a problem now? Funding is a problem with all early stage biotechs. If something "goes wrong" then it is not only funding that will be problem, but that is the risk you take with all early stage biotechs.
"One tailed or two, the numbers are really good, possibly the best ever seen in an ALS study."
I don't think your friend understands the significance of a one-tailed study. The power is greater in a one-tailed study compared to a two-tailed study of the same data. So of course the numbers are going to be really good. No scientist or scientific group will put much weight into efficacy results of a one-tailed data. The guidance Genervon is looking for will probably result in being asked to do a Phase 2b well-controlled trial. Here is a link to a training protocol sheet from the NIH. Note page 3:
Power is Affected by…..
• One-tailed vs. two-tailed tests
– Power is greater in one-tailed tests than in
comparable two-tailed tests
https://ippcr.nihtraining.com/handouts/2013/Johnson_SSP_11_19_13_C.pdf
While we are on the topic of the data, there are some other issues I have. The PR said that 8 patients were randomized to drug and 4 to placebo. Yet it also says that the 8 drug treated patients were compared to "historical controls" rather to the 4 placebo patients. Why even have placebo then? That is really strange. Also, they provided only aggregate data on the 8 patients and no baseline or endpoint data on the 8 of them in regard to ALSFRS-r or SVC. It makes it very difficult to interpret the data.
"That is where the money will go. If it were public my guess is the stock would have doubled at least on the news. Not only that it apparently has potential impact on Parkinson's. "
That is just a bunch of guessing. NurOwn also has potential impact on Parkinson's. That is what NurOwn was originally developed for and all of the pre-clinical data suggests it has a biological impact.
"BCLI may not have enough money to finish their current round to testing. If they do not get numbers equal to Gene's I doubt if anyone will want to fund future research."
That is also incorrect The company has guided on several occasions that they have enough cash to fully fund Phase 2 in the US to completion. Regardless I expect them to do a raise in conjunction with the publication of Phase 2a data, and I do not think they will have a problem at all.
Bottom line, and again no disrespect to your friend, but it seems like he made several conclusions based on incorrect information and unconclusive scientific data that still raises lots of questions. The fact of the matter is with Phase 2 initiated in the US, another indication about to filed for soon (another catalyst your friend forgot to mention), a very undervalued market cap, and a very high quality CEO at the helm, there is a lot to like about this company going forward. No doubt there will be bumps along the way and I am sure more competition is out there, but that is not a bad thing in my opinion.
First, I noticed something interesting from the PR yesterday. They said the following under the PD Clinical Data:
"2.) Changes in 4 out of the 8 secondary clinical outcome measures (UPDRS ADL, Schwab & England, Hoehn & Yahr and MOCA) at week 2 (visit 6) were statistically significant at the one-tailed 10% level."
A one-tailed study would only be measuring one direction of the data and would greatly inflate the data numbers. Of course BCLI and CUR are doing two-tailed studies, measuring both directions of the effect of the treatment. Presenting one-tailed data to the FDA would almost certainly result in the FDA saying "great now do it again in a two-tailed study".
Here is a good paper on the difference between one-tailed and two-tailed studies:
www.ats.ucla.edu/stat/mult_pkg/faq/general/tail_tests.htm
(excerpt)
"When is a one-tailed test NOT appropriate?
Choosing a one-tailed test for the sole purpose of attaining significance is not appropriate. Choosing a one-tailed test after running a two-tailed test that failed to reject the null hypothesis is not appropriate, no matter how "close" to significant the two-tailed test was. Using statistical tests inappropriately can lead to invalid results that are not replicable and highly questionable--a steep price to pay for a significance star in your results table!"
Genervon simply wanted to prove that there is a positive effect in one direction from their treatment. After checking clinicaltrials.gov, I confirmed this as it is indeed just a "pilot trial":
"GM604 Phase 2a Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS)(GALS)"
(Description of the trial)
"1. This pilot trial is designed to test proof of principle, i.e. determine if a 2-week IV bolus treatment with this agent can (1) change ALS protein expression (target biomarkers and efficacy biomarkers) after treatment (2) have preliminary effects measures of ALS disease clinical progression."
What is a pilot trial?:
m.circ.ahajournals.org/content/119/13/1694.extract
"Pilot trials are exploratory studies limited in size and scope that give insight into the actions, efficacy, and safety of a drug or device, but cannot provide definitive support for specific mechanists or therapeutic claims."
So to make a long story short, Genervon's trial seems to be a one-tailed pilot study that is only measuring one direction and cannot really be used to fairly and accurately measure statistical significance or make therapeutic claims. Of course that is fine as it is just a pilot study, but I think it is a little misleading in the way they touted the results.
Would love to hear any feedback or corrections if I am wrong in my analysis of this.
In case you missed it, here is the data presented by the private company Genervon from their Phase 2a trial. At first glance it is very positive and was likely responsible for the Cur and BCLI sell yesterday:
http://www.businesswire.com/news/home/20141019005074/en/Genervon-Announces-ALS-PD-Phase-2a-Trial#.VEZOlIvLdFk
I said at first glance because I did some digging into Genervon's data and found some important things that I think clearly change the strength of their data and it was interpreted by the market.
I posted the same thing at Yahoo and thebiotechinvestor, but here is the cliff's notes version. I'll try to post a more detailed version in a bit:
The Genervon ALS Phase 2a trial was a simple pilot study which seems to have been done as a "one-tailed" study. They mentioned "one-tailed" in the PR and most pilot studies, where they are simply just trying to test a hypothesis, are one-tailed. One-tailed trial data will have greatly inflated numbers as it is only measuring one direction of the effect of treatment. Where as a two-tailed trial (what BCLI and CUR are doing) measures both directions and therefore the numbers are lower.
I think it is pretty clear that this is the case with Genervon's trial data, but would of course appreciate anyone to look at it my "analysis" which I'll try and post below, and punch holes in it.
What is confusing about that statement? Data from Phase II currently being enrolled in the USA will be available in early 2016. Pretty straight forward to me.
I was surprised at the reaction as well since it was such a frank and realistic view of what lies ahead. I think it could have been due to investors liking a straight shooting CEO who doesn't BS. It could also be due to the statement that Fiorino is pursuing funding from the ice bucket challenge donations. It would be non-dilutive and I imagine if anyone BCLI is a perfect candidate to receive some of it. Another reason may have been because of the statement about working to get another indication up and running. Which in my opinion will be Parkinson's. A Parkinson's IND filing could be a nice pps driver as the market it represents is much much larger than ALS.