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ATHX on FOX News! The word is getting out! Great job, Gil...
https://www.foxnews.com/health/cell-therapy-coronavirus-treatment-cleveland-biotech-company
What are the finances like for the company? Will they need to dilute soon? What is the situation with Lincoln?
Again, I'm a newbie here, so please forgive me for asking questions like this.
New here. I understand the importance of controlling cytokine storms.
Why is this stock so thinly traded? Even with news?
Burning cash way too quickly for results. I'm removing ADXS from my coverage.
Will be loss leader in 2018 after needed dilution.
Punit's Tweet yesterday:
@PunitDhillon: A tough week @Oncosec this week due to unexpected external pressures... But we are not letting down & looking fwd to pushing ahead!
Vintage Punit.
Creating confusion and lack of clarity. "What" external pressures?
This guy is clearly in way over his head. Others have said that before me, and others will say it after me. IF he didn't have the family protection of his uncle (Avtar) in place there would undoubtedly already have been a campaign by major shareholders to oust him long ago. And the 0.37 warrants? If that's not a slap in the face to retail investors, I don't know what is. Gee, how hard are you going to have to work for that, Punit?
He's got a LOT to learn in terms of public relations and setting expectations.
Punit clearly likes social media. From that we can probably surmise that he checks "investor sentiment" from time-to-time at the various Investor message boards. It is hoped that he monitors this board on a semi-regular basis, or actually even gets a daily or weekly feed from it.
That being the case, I'm considering writing an open letter to Punit here and at other message boards. And I'm not even a shareholder anymore. But I feel for the folks who've been led down the wrong path of unrealistic expectations. It has no doubt cost people a lot of money either in real or paper losses. That hurts. But what hurts even more is the opportunity cost which many have missed as biotech explodes elsewhere. You don't get many opportunities like this in a lifetime. For those who tied all of their money up here it's a missed opportunity on a grand scale.
I'd like to see more tangible results from management. And transparency with CLARITY. I truly don't believe they are doing enough with the $30M they have in the bank. It's definitely job security. For awhile. Or until the next dilution.
GLTA.
We see $3 plus on Monday...
http://www.chugai-pharm.co.jp/english/news/detail/20150302083000.html
License Agreement and Collaboration with Chugai Pharma in Japan
Athersys and Chugai Enter License Agreement and Collaboration to Develop MultiStem® Cell Therapy for Ischemic Stroke in Japan
Regenerative medicine partnership focused on development of novel stem cell therapy
March 2, 2015 (CLEVELAND, TOKYO) – Athersys, Inc. (NASDAQ: ATHX) and Chugai Pharmaceutical Co., Ltd. (Tokyo Stock Exchange: 4519) have announced a partnership and license agreement to exclusively develop and commercialize MultiStem® cell therapy for ischemic stroke in Japan. Ischemic stroke represents a priority disease area in Japan, given the high healthcare burden of the condition and the expected increase in incidence associated with Japan’s aging population.
Athersys’ proprietary cell therapy product, MultiStem, is currently being evaluated in a Phase 2 clinical study for ischemic stroke in the United States and Europe, and Athersys has begun preparations for clinical development in Japan, including engagement with the Japanese Health Authority. Chugai is a leading research-based pharmaceutical company with strengths in biotechnology products, and brings to the collaboration substantial expertise and experience in late-stage development and commercialization in Japan.
“We are delighted to have concluded a license agreement with Athersys for the development and marketing of MultiStem, a very innovative cell therapy under clinical development,” said President and Chief Operation Officer at Chugai, Tatsuro Kosaka. “By combining Chugai’s strong expertise in biological pharmaceuticals, we hope to bring MultiStem to the Japanese healthcare system as a new treatment modality during the critical phase of ischemic stroke.”
“We are excited to be working with Chugai in this important area and look forward to combining our respective capabilities and expertise to successfully develop and commercialize MultiStem for the treatment of ischemic stroke in Japan,” said Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer at Athersys.
We see $3 plus on Monday...
I generally agree with you with one large caveat:
Are the TINY sample sizes for these trials (10 patients each) enough to show statistical relevance and scientific proof of concept for each trial? Beyond that, are the sample sizes large enough for big pharma to "buy in to?" That's my biggest concern right now.
I also have a concern that ONCS seems to be slow getting out of the starting blocks. At this writing it is only known that these trials will begin this year (most likely Q1), but no clear date has been set. Any word on this?
We're in a race and the clock is ticking.
I must agree with you here.
The company is doing a LOT of good things for science, but until big pharma starts to recognize commercial opportunity here through real partnerships (with money up-front), then the PPS will be range bound for the foreseeable future from about 0.35 to about 0.50.
My .02.
Just be patient and wait for corporate guidance coming in January.
Either you will believe ONCS management and their guidance or you won't.
And let's also wait and see what appears in the U.S. Government Clinical Trials database, once P2b is published there.
Signing off for the New Year. Take care.
I wouldn't read too much into this. Last trading day of the year.
I disagree with you.
And the company will prove you wrong when they provide guidance for the rest of the year in January.
2015 will be a very exciting year for ONCS and its shareholders. I wouldn't want to be short at these levels. The P2b trial won't be the only game in town for ONCS.
Happy New Year.
No.
You need to wait and see for the protocol to appear in the Clinical Trials database in a couple of weeks.
Good interim data (sometime this year) is all that will be needed for a buyout to potentially occur.
Others have a different view than you.
No worries.
Wrong again. Perfect logic.
Yes, but too early to speculate on that.
The P2b trial MUST progress well and meet or beat expectations.
It ALL depends on how the P2b trial progresses.
Ever hear of a pseudonym or a "ghostwriter?"
See this at the end of his article:
[ DOCUMENT END ]
NOTE: This document represents the view of the author. Readers are responsible for their own due diligence. Everything in this article can be backed up by journalistic articles, scientific literature and data (except of course the guesstimate on Immunopulse+PD1 efficacy). Google is your friend. Use it to verify the claims made in here before you decide on an investment.
Additionaly note, this article was not written by me, but has been posted here with permission from the original author. Though I share his/her opinion on the information shared, it is your responsibility to verify.
You are incorrect.
The PhD and medical doctor with over 10 years of verifiable experience in the immunology field was responsible for much of THAT valuation case for ONCS.
Can you bring someone with comparable skills and background to debate this particular valuation case, point-by-point?
You are free of course to have your opinion.
You have your opinion and we have ours. That's fair.
No it wasn't.
The results are very promising.
I completely agree.
Can you tell us why?
We've provided you with metrics why they are convincing (or at least promising) to big players in the industry.
Can you speak in specific terms why they are not promising to you personally?
I am completely open to hear a contrarian viewpoint or dismissive outlook, as long as there is solid rationale behind it.
Leading biotech companies may disagree with you.
Amgen purchased T-VEC from Biovex for $425M cash up front with milestone incentives totaling $1B in 2011:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=109088921
The efficacy and safety profile for T-VEC as a monotherapy was similar, but not quite as good as ONCS' ImmunoPulse.
The recent T-VEC/Yervoy combination results are very good and there is much excitement around the ImmunoPulse/Keytruda PD1 combination which may offer even better efficacy without side effects.
Why would you not be excited about such a combination? Clearly, leading experts in the field of oncology and immunology are. What technology interests you more and why?
The science and the data so far are very promising.
Any speculation is fair game. Those are just numbers. Some real examples have been given with multiples larger than that.
One could also speculate that ONCS will never make it and get stuck under 0.10 for a long time. That's fair too.
One just doesn't know for sure. Anything is possible going forward. Again, speculation is just that; nothing more, nothing less.
I'd personally rather focus on the science. At the end of the day, that is what will make a real and tangible difference for cancer patients and for those who have invested in ONCS and other cancer-fighting companies as well.
ONCS vs. Advaxis:
1) Advaxis uses gene modified live bacteria. Bacteria is rendered "harmless". However, it still wakes up the immune system (our innate system is coded to get revved up when it sees bacteria)
2) Bacteria is also embedded with DNA plasmid that encodes single target antigen. This antigen is a "well known" antigen for a specific cancer. They can target different antigens for different cancers.
3) Results from Advaxis HPV trial:
- 11% ORR
- additionally about 30% had "stable disease".
This is the characteristic pattern of responses from vaccines where very little actual visible shrinkage. But more so "stable or slowing of disease". The 11% ORR is at least better than nothing.
4) Toxicity - relatively mild. Fever, chills and cytokine release syndromes from live bacteria infusion. Seems more so than Tvec virus. But overall manageable. Requires antibiotic to eliminate the live bacteria after.
5) It is CLEAR the company sees no future in monotherapy (with the less than so so results above). Therefore, they have immediately changed strategy, hired a reputable new CMO and pushing hard for combination PD1 trials. They are starting 2 combo trials. One with Merck. One with MedImmune. Like Tvec and ONCS, they are hoping for big increase in responses from combination.
This brings me to the crux. I repeat - very very few vaccines lead to obvious, visible, regression of tumors. Traditionally, vaccines have led to slowing of disease, or making cancer come back slower after surgery (cutting it out). But very few actually cause tumors to disappear. Tvec & ONCS have very clear shrinkage of tumors. Actual shrinkage has only been reliably seen with CAR-T and PD1.
As to whether combo Advaxis+PD1 will be as good or better than Tvec/Immunopulse + PD1, since they have no human data, the only clue we can use is their mouse data.
Mouse data:
(a) We know ONCS mouse data shows 100% complete regression with Immunopulse + PD1
(b) Advaxis+PD1 yields 20% complete regression (compare that to Immunopulse 100% regression).
The 20% vs 100% in mice should give you an idea as to comparative efficacy.
A buyout is only a possibility and it wouldn't happen until the efficacy/toxicity profile of Keytruda/PD-1/IL-12/ImmunoPulse combination is shown to be effective.
I refuse to speculate further than that, only that a possibility may exist down the road at some point.
None of us can really do more than simply speculate, which is fair game. And speculation is just that, nothing more, nothing less. Your mileage may vary.
Buyout discussions are typically not held in the public domain. They are usually held behind closed doors with appropriate NDAs in place. Therefore, no one in the public domain knows whether such discussions are taking place or what outcome will be derived from such discussions between ONCS and any potential suitor.
It also follows that NO logical assertions can be made that such discussions are NOT taking place, due to a lack of perfect information in the public domain.
Conjecture is fine on either side of the argument.
My own take is that ONCS won't be a potential buyout candidate until they minimally release expected positive P2b interim trial results sometime in 2015.
Do you have a link to your chart?
We'd like to see it.
For investors the bottom line is how much the buyout affects the price of the stock. Your mileage may vary.
Glad that you find the exchange helpful.
2015 should be a very interesting year for ONCS.
Thanks for your opinion.
We will have to agree to disagree on that in this particular case.
The mechanisms are pretty well understood in this particular comparison.
The early efficacy was similar with ImmunoPulse enjoying a slight advantage over T-VEC.
We will have to agree to disagree on the valuation paid.
The Wall Street Journal indicated the total valuation at $1B.
The rest of my post is very informative.
You clearly misread my post or posted a few seconds before I made one change to it. Sorry for the confusion.
The rest of the post is extremely informative.
Amgen purchased Biovex at a valuation of $1B. Amgen did not actually pay $1B up front. I believe it was about 420 million up front and the rest in milestone payments. This is simply the nature of biotech deals. A portion is paid up front, then when certain miletones are hit the rest follows. To omit the milestone promises from the valuation total would be deficient and misleading. Look at the "title" of the Wall Street Journal article which covered the buyout. (e.g. "Bought for $1B.)
In immunotherapy trials, investigators are seeing very consistent results between Phase 1, 2 and 3. You can go compare Yervoy and PD1 phase 2/3 results with earlier Phase 1. You will see for yourself that the ORRs and CRs are basically the same (providing for rounding error due to sample size). This pattern is also clearly seen in ONCS Phase 1 and Phase 2 trial results. This consistency was not commonly reproducible with the older targeted agents and chemo drugs. Why? Most likely because of the PATHETIC efficacy of older drugs. Weak efficacy led to investigators trying to game the system. They would try to select only the "healthier" patients - those who weren't about to die. They could game this in Phase 1 and 2, but in Phase 3 the true efficacy would come out.
A second very important difference is that these older cytotoxic and pathway inhibitors attacked the cancer directly. The problem is this quickly selects for cancer cells that are not affected by that drug. So, a common observation was that patients might experience initial shrinkage of their tumors, but the OS (overall survival) was NOT improved. Tumors would shrink, and patients experience maybe 1 or 2 months of improved PFS (progression free survival). Meaning their cancers stopped growing for a few weeks/months. But when the cancer returned, it grew even faster and the patients, on average, died within the same amount of time.
For immunotherapy, things are very different. In many of these trials, patients had failed multiple prior chemo regimens. More importantly, it is very difficult to game the immune system. You either succeed in getting the immune system to work, or you don't. If it works, it tends to work in predictable fashion. Furthermore, responses tend to be far more durable than many of the older cytotoxics. The fundamental difference is that the older failed extrapolations involved drugs that attacked the cancer directly. In contrast, immunotherapy empowers the immune system to attack the cancer. The immune system is adaptive and it is much harder for the cancer to "escape". This is how you get patients with years-long durable complete regressions with only a few PD1 infusions performed years ago.
The indisputable fact is that the pharmaceutical industry and medical community has voted with BILLIONS of dollars and resources to focus on PD1 instead of Yervoy. This is not just because of superior toxicity, but significantly superior efficacy.
While it obviously remains to be seen of Tvec+PD1 would be superior to Tvec+CTLA4, the risk is more to the upside (that PD1 will work better than Yervoy). If Amgen KNEW for sure that PD1 is better than Yervoy, there would be no risk, and ONCS would not be $100m, but far closer to the $1B today. Hence the time to "place your bets" is obviously right now. Amgen has done so. Otherwise, with the superb Phase 1/2 Tvec+Yervoy results, why didn't they move on to Phase 3?? Why would they instead choose to switch to Tvec+PD1? The answer is obvious.