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.
Big pharma faces costly setback in cancer fight
https://www.ft.com/content/24441526-ede0-11e6-ba01-119a44939bb6
Mysterious $5 Billion Biotech Moderna Hit With Legal Setback Related To Key Technology
http://www.forbes.com/sites/nathanvardi/2017/02/09/mysterious-5-billion-biotech-moderna-hit-with-legal-setback-related-to-key-technology/#734b46b42d17
A few more points that might be of interest:
- The existing investigator-sponsored Keytruda combo trial in melanoma will recruit actual non-responders to Keytruda only (as opposed to biomarker predicted non-responders in the first 15) for the remainder of the trial. The immune monitoring data being released on Feb 23 at ASCO-SITC is from this trial.
- Besides the above investigator trial at UCSF, ONCS will be doing its own registration trial in melanoma for patients refractory to anti-PD1 treatment. Patient enrollment is expected to start in Q2 2017. Targetted commercialization is in 2019 with possibility of AA as it is an open label study and there are no other companies targeting to treat patients refractory to anti-PD1.
- For this registration trial, ONCS has said in oral and written presentations that a drug supply partnership is being finalized (they say it's going to be with a "multinational" - we know it is going to be MRK*). At ~65 patients x $150,000 per patient, free Keytruda for the trial would be worth ~ $9.7M. The big question is, will there be an upfront payment as well?
- I believe there will be. At slide #24 of the below webcast from Jan 31, Punit Dhillon talks about peers who might not get to market as fast as ONCS but have valuations in the $300M - $700M range while ONCS sits at $23M. He says this number is going to improve this year. I take this as a hint that the drug supply partnership could include an upfront amount. I could be wrong.
http://noble.mediasite.com/mediasite/Play/8cc84444839e4c1d8edd0504ac99d3e41d?catalog=fafdf0fc-32ee-46e6-af06-097ccda932a2
* Skip to the last slide in the above Noble webcast, second question from the audience regarding drug supply partnership.
------
- At a previous presentation, Punit also says their lead program (ImmunoPulse IL-12) could see an exit opportunity within 18 months.
- Besides the above, they have launched a Technology Access Program and in a previous investor presentation Punit said they will announce a few collaborations this year to monetize their TRACE device. Also, as per my understanding, in the event of a sale of the lead program, ONCS will retain TRACE and develop their multigene candidate which could be quite disruptive (please see few but insightful posts from hschlauch at the ONCS iHub board). The collaboration will include a spinoff biotech from KU Leuven. KU Leuven (Belgium) is known btw for spinning off biotechs which have secured 9 figure partnerships with big pharma.
http://oncosec.com/videos/#31
- This company has a lot to going on and its market cap should see an inflection point this year, IMO.
More than a guess :) Please refer to the 2nd LA Times link on this page:
http://oncosec.com/patients-perspective/
My cancer has backed away too. Under the care of oncologist Dr. Alain Algazi, a skin cancer specialist and research scientist at UC San Francisco, my treatment consists of two parts. The first involves a clinical trial with an experimental gene therapy regimen. Since the fall I have been getting injections of the genetic material pIL-12 with electroporation (yes, that’s electric shock) on a six-week cycle. (Our next-door neighbor, a genetic scientist, calls me a human GMO.) The gene therapy regimen is designed to make my tumors more likely to respond to the second part of my treatment: Despite it’s not being approved by the Food and Drug Administration for my type of cancer, I have received infusions since January of Keytruda (pembrolizumab), the immunotherapy drug taken by Carter.
Thanks for sharing hschlauch.
I find it hard to believe that H&N cancer will not be continued in a combination regimen and registration path until they are first done with melanoma or until they have the resources. That's 2-3 years of opportunity cost IMO.
Anyway, my personal opinion is that if and after the melanoma registration trial meets its endpoints, MRK will offer to buy ImmunoPulse IL-12 and scale up the use of this technology in additional indications as well. Punit did mention in one of the recent conferences that there may be an exit opportunity for the current lead program within 18 months. I wouldn't be surprised if that happens, and comes with milestone payments for each additional indication that MRK wishes to pursue using EP IL-12.
PBS Newshour: Cancer immunotherapy has life-saving powers — and limits
http://www.pbs.org/newshour/bb/cancer-immunotherapy-life-saving-powers-limits/
The first segment features cancer survivor Melinda Welsh, an ONCS combination treatment patient, and lead investigator for ONCS, Dr. Alain Algazi.
This PBS segment does not mention ONCS. But here lies an opportunity to understand the company's potential before the market does, IMO.
Earlier coverage on The LA Times:
http://oncosec.com/patients-perspective/
ONCS +12.7% and 22x 50-day avg. volume on upcoming ASCO-SITC clinical data PR
http://finance.yahoo.com/news/oncosec-present-clinical-data-phase-110100992.html
Also presenting corporate updates at two investor conferences in February.
I'd say today's volume is a mix of people who are getting in based on the PR as well as day traders (mostly IMO) from chat room alerts who are in for quick profits.
Knowing what you own is important. While many people have been driven away by the PPS decline, I've viewed this as an opportunity to average down and build a bigger position.
Just my personal opinion and not investment advice.
NASDAQ says the stock will be halted until the company provides the info that they have requested. Doesn't look good.
Also an independent director had resigned two weeks ago for "personal reasons."
http://www.streetinsider.com/dr/news.php?id=12459161&gfv=1
Big Pharma’s Offer to Trump: Discounts When Drugs Don’t Work
https://www.bloomberg.com/news/articles/2017-02-06/big-pharma-s-offer-to-trump-discounts-when-drugs-don-t-work
President Donald Trump says drug prices are astronomical and something needs to be done. Pharmaceutical giants have an answer that doesn’t involve lowering list prices: refunding some of the money to insurers if a drug doesn’t work as expected.
The concept of pay-for-performance isn’t new in the industry. But the number of such agreements between drugmakers and insurers has grown in the past year as Big Pharma seeks to defuse criticism over the soaring prices of some brand drugs, which can cost $10,000 a month or more for cancer treatments.
“The new government in the U.S. with Trump talks about getting more value for less,” said Lars Fruergaard Jorgensen, chief executive officer of Novo Nordisk A/S, the world’s biggest maker of diabetes medicines. “Outcomes-based contracting could be one of the elements.”
That is in fact the driver. Seems AZN wants a piece of the pie too.
AZ chief: Durvalumab's ready for a 'marketing battle' against I-O heavyweights Opdivo, Keytruda
http://www.fiercepharma.com/marketing/if-az-can-turn-i-o-into-a-marketing-battle-we-re-ready-ceo-says
KTOV -50%; CEO detained and questioned for fraud
$KTOV CEO was detained and questioned for fraud. Another Israeli small bio...https://t.co/TV7tCDbhCN
— Andy Biotech (@AndyBiotech) February 6, 2017
The way I see it ahab, PD can't say this will be an inflection year for the market cap based on any upcoming data - the market decides that. Only way he can say so IMO is if he knows there's going to be a partnership that will create a new floor for the share price. That's what I'm looking forward to in the coming months. GL to you too.
Opdivo still clear immunotherapy leader despite Keytruda gains
http://pharmaphorum.com/news/opdivo-still-leader-keytruda-gains/
...But while Merck has all the momentum behind it, BMS’ Opdivo is very much the market leader in terms of revenues – at least for now.
While Keytruda reached sales of $1.40 billion for 2016, Opdivo was way out ahead with revenues of $3.77 billion. Keytruda is expected to overhaul it in the long run, but Opdivo produced excellent growth in Q4, with revenues growing to $1.3bn compared to $475 million the year before.
If I may, you are right that investors have been calling every year the inflection year since 2014. For what it's worth, the difference this time is that it's the company which is publicly making this statement in their presentations. It remains to be seen if this will make any difference.
I would have liked to see a bigger purchase as well. But I guess I'm ok with the fact that he has a decent stake already. BTW his last big purchase that I recall was worth $40,000 when the stock was trading at $0.80 pre-reverse split ($16 in today's prices).
Punit owns 224,700 shares (not options) of ONCS, which is about 1.14% of outstanding shares. That's a significant holding IMO as well. Also to be noted is that he has not sold a single ONCS share to this date. His net worth and interests are aligned with that of investors' without a doubt.
BIO Asia International Conference - Accelerate your pathway to partnerships in Asia
March 14-15, 2017 | Grand Hyatt Tokyo, Japan
https://www.bio.org/events/bio-asia-international-conference
BIO Europe Spring - 11th Annual International Partnering Conference
March 20-22, 2017 | Barcelona, Spain
http://www.ebdgroup.com/bes/core/presenting-companies.php?_ga=1.70306388.512015811.1481647640
Not all participating companies are presenting. ONCS will be presenting.
I call you smart. I plan to add some more in the coming weeks.
Bio CEO & Investor Conference
February 13-14, 2017 | The Waldorf Astoria, New York, NY
https://www.bio.org/sites/default/files/BIO%20CEO%202017%20eBrochure.pdf
Thankfully I exited from my position at $3.25.
Sounds fair. I hadn't read this before. Thanks for re-sharing. As long as safety isn't ignored, I guess this could be a good thing.
I surely look forward to an efficient FDA but I also hope it won't be a lax one, granting approvals left and right with a lowered bar. That would have serious implications for both patients and investors.
I don't think patients should be subject to treatments with side effects the cause of which a company cannot determine (recent JUNO deaths for example). Also if I get sick, I wouldn't want to consume medicine that may be inferior in quality. You get the gist.
For investors, particularly of small companies like ONCS, you wouldn't want your competitors/peers getting FDA approval for treatment of anti PD1 refractory melanoma patients for example if the treatment of the other companies is inferior but just cuts the FDA's lowered bar. Unhealthy competition could arise - the company with the inferior product may lower its prices to woo patients. Well-capitalized companies might "buy" doctors who could make their patients take the treatment from the companies that pay them.
PS. I don't think ONCS will need a lax FDA to get to market in 2019 but it surely could benefit from an efficient FDA.
My interpretation is that commercial pathway is not the same as commercialization, which can happen in 2019. I think by pathway they mean the process to commercialization (involvement of FDA, partner, etc).
Here you go. Copied link from my phone (mobile version) so in case it does not work you can go to the Nobel website and look in the Webcasts section.
http://noble.mediasite.com/Mediasite/Catalog/Mobile/FolderPresentation/fafdf0fc-32ee-46e6-af06-097ccda932a2/fafdf0fc-32ee-46e6-af06-097ccda932a2/8cc84444839e4c1d8edd0504ac99d3e41d/
There was a slide Pd went through in NobelCon presentation showing peer MC in a couple of hundred million and ONCS at $23M. He said that's going to correct this year. It's a matter of if you trust him on that or not. I do.
At about 65 patients for the registration trial times $150,000 for Keytruda, that would be worth $9.75M worth of assistance with validation from big pharma. Considering current market cap that's significant. There's a chance PD is underpromising to overdeliver i.e. there could be some upfront payment, IMO.
Hi Ahab, as I referenced in my last post, RS or Nasdaq delisting is a lengthy process that could take a year. I expect ONCS to produce a catalyst this quarter (drug supply partnership with MRK). I'm not counting on ASCO-SITC immune monitoring data to blow everyones' minds on Feb 23. I'm solely expecting the drug supply partnership with MRK to be finalized and serve as the inflection point. The market and even many longtime investors don't seem to be expecting this to happen despite the messaging from the company being clear on this. I see this as an opportunity to pick up some cheap shares. This may sound cliche and like a one-sided and perhaps stubborn assessment of the situation but this is what I personally believe is going to happen based on my DD.
I haven't sold and plan to average down further in coming weeks. I've changed my attitude on the SP btw; now I kind of wish it goes below a dollar until news and I also wish they don't release news until the end of Q1. Know what you own would be my suggestion. GL to all.
I have seen however, some companies execute a RS anyway to regain compliance and not make full use of the extension if they do not have near term catalysts to raise the PPS above $1. Hoping that won't be the case with ONCS.
Pfizer set to lose ‘billions of dollars’ as drug patents expire
http://www.irishtimes.com/business/health-pharma/pfizer-set-to-lose-billions-of-dollars-as-drug-patents-expire-1.2958028#.WJDnyoN7mww.twitter
That is inaccurate Twiz. Delisting does not happen that fast. If the stock closes below $1 for 30 consecutive days, ONCS will get a Deficiency Notice from NASDAQ. It then has 180 days to regain compliance (needs to close above a dollar for 10 consecutive days within this period). At the end of the 6 months, they can request for another 180 days extension. In a nutshell ONCS will have a year to turn around the stock before it gets booted off Nasdaq, that is, if it gets a deficiency notice in the first place.
http://finance.zacks.com/nasdaq-delisting-rules-7450.html
TENX -76%; Tenax Therapeutics Announces Top-Line Results From Phase 3 LEVO-CTS Trial in Cardiac Surgery
http://finance.yahoo.com/news/tenax-therapeutics-announces-top-line-140000313.html
Ahab I think I remember seeing Ridgeback showing a zero position on Nasdaq institutional holders page a couple of quarters ago. I don't believe the recent sell off is due to them. December was probably mostly tax loss selling after Nov 11 data didn't move SP.
Ridgeback is doing compliance housekeeping it seems. If you go to insidercow.com and search for ONCS then go to the institutional page and then click on Ridgeback, you will see they filed for buying CPXX, which was bought out in June of last year, today. Why file it today? Perhaps they just forgot to file these on time and are doing it now for compliance reasons. I therefore wouldn't be worried about this filing at all.
[PS. Sorry, for some reason insidercow won't let me copy a working link, hence the directions to view Ridgeback's activity.]
Ridgeback sold out a few quarters ago. They've not been in the institutional holders list for a while. Interesting that they filed this so late.
Thank you dia76ca. I appreciate your DD as well and wish us both well on our investments.
What I meant to refer to was the change in platform (not pipeline) from ImPACT to ComPACT, which would require trials to be restarted from preclinical stages. ONCS on the other hand is moving to a registration trial after interim data from its P2B trial. I wanted to give an example of what a clinical setback looks like, from a timeline perspective. Dissing HTBX stock was not my intention.
As for the R/S, ONCS did have one to uplist to NASDAQ. Here I think Punit used a transparent process to get the uplisting done. Conversely, I hope you won't deny Jeffrey Wolf's use of a PR stunt in July ("alternate options presented" after canceling equity offering from previous day) to create speculation of a buyout to artificially pump share price in order to maintain NASDAQ listing. As much as I appreciate the scientific team at Heat, the challenges of the bladder trial, and the immune response that was achieved, Jeffrey Wolf is one CEO whom I would never trust again, not just for pulling the PR stunt but also withholding bad data till the very end despite seeing investors pouring in money on a failed trial for such a prolonged time (till late November when Estimated Primary Completion Date per clinicaltrials.gov was June 2016 for HS-410).
MRK just took an unprecedented move to counter criticism about rising prices
http://finance.yahoo.com/news/huge-drugmaker-just-took-unprecedented-173708100.html
Merck, the giant drug company known for its cancer immunotherapy drug Keytruda and its vaccines business, has published a report that outlined the company's average list price increases for its products.
The report also lists net prices — or the amount Merck actually receives after factoring in rebates and other discounts that drugmakers payout.
It's an effort to diffuse criticism faced by the entire industry that drug prices are out of control. While it has been a hotly covered topic for several years, President Donald Trump recently raised the stakes by saying that drug companies are "getting away with murder."
In 2016, Merck raised prices by an average of 9.6%. But after factoring in rebates, that was just 5.5% (a rate that's still higher than the rate of inflation).
"We've taken a close look at our pricing practices – and we believe we have a good track record," Adam Schechter, president of global human health at Merck wrote in an accompanying post on the company's Website. "Since 2010, Merck’s average net price increase across our portfolio each year has been in the low to mid-single digits: specifically, 3.4 percent to 6.2 percent."
Hi ahab, I understand the frustration with the share price. However, I do not agree with "those paths to date are not leading anywhere that seems to make a difference" with all due respect, because the current p2b trial has given them enough basis to go to the FDA to discuss a registration trial, which is beginning next quarter. Not many companies can go from data from 15 patients to a registration trial. I don't quite understand why we are feeling as if this p2b trial was a failure. It did not pop the share price as we might have hoped, that I agree, but it was only because it needed to prove itself in a bigger sample. Companies use investigator sponsored trials to plan registration trials because these ISTs allow the flexibility to modify trial protocol and optimize the route to success.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=126674355
HTBX failed a p2 trial; that's how a company with a ditched pipeline looks like; its share price tanked below a dollar. If ONCS had failed p2b and was doing a pipeline reboot, I think we would be under a dollar by now.
Lastly, Bleomycin was a chemotherapy drug. That was a good reason to shelve it. Maybe in a few years the multigene cocktail will in fact be the best weapon in ONCS pipeline but that should not take value creating opportunity away from current IL-12 combo in melanoma for a good 5-6 years, IMO.