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Key information to review from an article published earlier this year about the Oncosec/Merck collaboration.
Market value
There are about 15,700 patients receiving anti-PD-1 therapy for melanoma, of which about 10,200 of them are nonresponders. If ImmunoPulse IL-12 can show a 30% response rate for nonresponders, that would increase the addressable market by about 3,060 patients. At a cost of $150,000 per year, that translates to revenues of about $460 million annually. Considering that, the fact OncoSec has a market cap of only $24 million means if the registrational phase II succeeds, shares could be quickly revalued higher.
Beyond that, if successful with melanoma, OncoSec and Merck may expand the combination therapy to other cancers Keytruda is already approved to treat. These include head and neck cancer and lung cancer, with the same regulatory pathway of conditional approval after a registrational phase II trial. Success with Keytruda could also open the door to Opdivo and collaborating with Bristol-Myers.
Safety bonus
There is one aspect of ImmunoPulse IL-12 that is often overlooked, and that is the safety of the plasmid DNA approach. Introducing immune proteins directly into the body can sometimes trigger immune overreactions because they are administered systemically. ImmunoPulse does not introduce the immune system proteins per se, but only the DNA plasmids that encode for them. That way, the immune system can decide how it wants to respond to the specific cells secreting the protein, rather than being flooded with the direct protein that can cause dangerous side effects.
In other words, the safety profile of ImmunoPulse is expected to be solid.
The upcoming registrational trial is open-label, so investors will be able to track results as they are reported and could get a decent idea of whether the trial will succeed or not based on interim results, which could start coming in by the beginning of 2018.
Hey cool your jets, simply stating an example about market cap. We all know Endocyte has absolutely nothing to do with Oncosec or Merck regarding their drug program. Sheeeesh.
Endocyte made a pretty good share price move for only an "in licensing" deal. Oncosec is only 6 to 9 months away from an accelerated approval for the PISCES trial which is a regulatory trial....which means the product can be commercialized while the trial is ongoing. Sounds like money to me.
I only mentioned Endocyte because when they announced the 160 million dollar licensing deal, the share price moved up to reflect that number rather quickly. Just an example of what can happen quickly on a licensing deal for a small company. Oncosec has a $20 million market cap. If they scored a deal at that amount the share price would move up around 8x the current level. The $50 number reflects what Oncosec might get in a similar deal to the Amgen/T-vec deal). It isn't crazy talk. The market Oncosec is addressing amounts to $500 million. So if a company like Merck likes what they see when results are out next year, they might be interested in expanding the ep-il12 to other indications like TNBC......which Oncosec should be releasing some data on the monotherapy trial soon ( will be interesting to see if they are getting any response in that trial)....Merck is running ongoing TNBC trials too (maybe some synergy between the two). NSCLC, Head and Neck, bladder, Gastric, Renal Cell Carcinoma are all indications that Merck and Oncosec could explore using the ep-il12.....which would put the therapy in the Billions category. It is all speculation, but what is most important is that they release good data on the PISCES trial next year. If they don't and they fail then you can be very happy with your negative assessment Low. I am a believer in Oncosec and I think they have a very valid platform to address a need in a population of patients that have limited options at this point. If Oncosec makes it to market with the first approval in melanoma for the previously failed checkpoint therapy population, then that will be a big deal.
We have been hearing it for years but I would point out a similar circumstance such as Endocyte that was left for dead and then....boom....a licensing deal for 160 million dollars and their share price moves 300% over a few days. That is the position Oncosec is at right now. All these years have been building up to this moment and PISCES trial. The previous data they have been building upon for years substantiates that they are headed for success and Merck is in joint meetings with the FDA to guarantee they do everything they need to do to get an accelerated approval next year, 2018, not 2020.We are at the crossroads now. It is time to invest.
The first stage of the trial will be 24 weeks of treatment which is 6 months and as stated by Punit they will release interim results thereafter.....that is a defined timeline to a game changing data release next year. Be a believer or not that is anybody's choice. Let me ask you this Dr. Low....if Oncosec were to release the data on the first 23 patients next spring and they come in at around 30% response rate or above that mark...and Merck were to offer them a deal worth 160 million dollars...nothing else for now....would that not equate to a higher share price of at least $5 to $8 /share in your opinion?
The defined timeline would be 6 to 9 months from the start of the PISCES trial which will be October 15 according to clinicaltrials.gov website. They only need a few patients to show a partial response to meet the 19% threshold to begin enrolling the second group of patients.
Now that we have a defined timeline, Institutions will be buying in the next few quarters at this low price. The risk/reward potential is too great here. We should see a price runup simply on speculation. Good news next year and the price for Oncosec stock will be staggering....the market will wake up! I for one am glad I am still in this.
Amgen forked out 1 Billion dollars to get their hands on T-Vec. If Merck were to buyout Oncosec we are probably looking at a similar overall deal with milestone payments....that would put Oncosec at around $50/share. Punit has mentioned in the past the undervaluation of Oncosec therapy compared to T-Vec. Enrollment is now open for the PISCES trial so we are on a defined path next year to release game-changing data ( AA approval is in the cards on good data so we won't be waiting till 2020).
Not surprising at all. With the PISCES trial beginning any time now, 6 months out and we get interim trial results that could result in an accelerated approval for Oncosec EP-il12 pembro combo therapy. Like I said yesterday, expect a spike of a few dollars on that type on news. Institutions will be buying in the next few quarters in anticipation of the data....bank on it. We should see a runup in the next few months back to $2.
Since Merck is holding Oncosec's hand and jointly going to meetings with the FDA, they are clearly keeping a hands on approach with Oncosec. Including the current combo study, Merck is invested in Oncosec for up to 30 million dollars worth of drug supply. I believe the two companies have an undisclosed agreement already for milestone payments if good results lead to an FDA (AA) approval next year.
Longer-term data is expected for the current p2b combo study with Merck's keytruda. Data will be released this quarter. Any more positive data on this study will be supportive of the PISCES trial that will open for enrollment any time now.
I believe that is a testament to the absolute focus on the Merck partnership. Punit has said Oncosec and Merck have jointly gone to the FDA to insure the regulatory pathway here. Merck is heavily involved in this. Only absolute solid data will convince the market though, so we must wait for that validating data to come out next year.
Friend, if you are holding 200,000 shares since 2014 then you are very under water like the rest of us longs, so you might as well ride out the entire wave here. My only regret is timing. The shift in the p2b pembro combo trial is what set us back. That trial was expected to get us early approval but Oncosec with Merck's guidance decided to focus on the previously failed pd-1population. This turns out to be our best path towards an approval and commercialization. The path is set so we just need good data and Oncosec stock will skyrocket. Oncosec website has been slowly updated of late. Yesterday I noticed they deleted all collaborators except Merck. Merck is our partner to the end in this. It is win or lose time. I think we cross the finish line. Hang in there!
I hope people are watching the move in Endocyte (ECYT) the past few days because this is the type of move Oncosec will see when we ink a licensing deal with Merck. Endocyte's licensing deal is worth 160 million...Oncosec will see a much larger deal probably and a much larger stock move.
At that buyout price Titan I would love to see a share swap of Oncosec shares for Merck shares.
I truly believe that good PISCES results will lead us to a buyout. A multi-gene trial in solid tumors or something else is on the back-burner for now. All focus is on the Merck combo trial because if this turns out well we are looking at the possibility of many indications for ep-il 12 in the non-responder populations for each indication. This would lead also to fast track and orphan drug designations too. A very sweet deal for an acquiring company. Merck will have first crack at this. They would be foolish to not buyout Oncosec on good results next year. But if they didn't there is always Bristol Myers and Roche......or even Pfizer or JNJ. Oncosec could become a subsidiary of any one of these large pharmas.
100% focus is on getting the PISCES trial underway and it is the clearest pathway to shareholder value according to Punit. Cutting costs and adding key people to the board to make this happen has been the priority. I'm not worried unless we don't get good trial results. I think we are lined up for commercial success or a buyout on good PISCES results.
Oncosec is going to have a binary, card-flip event...in Punit's own words.....when PISCES data is revealed next year. This is a high risk, high stakes gamble. The upside to the starting of the PISCES trial is that the bar is set pretty low for the first stage of the trial. They only need a response in 4 of the first 23 patients to move on to the second phase of the trial. That is only a 19% response rate and way lower than Oncosec has shown in the past results even if they were based on predicted responders. There seems to be a lot of faith in the bio-marker test used in the current combo study, so I am a believer that Oncosec will succeed.
With good PISCES results and an FDA approval the pipeline will reveal itself with each and every other indication that ep-il12 can be used for. It could become an instant pipeline in the making with one validating approval. We are on a fast track to an approval here when the PISCES trial gets under way.
PISCES trial status is still listed as not yet recruiting but the current combo trial is now listed as: Not Recruiting. They may have reached full enrollment in that study. Will be nice to see the next interim data release on that which Punit said will come this quarter at a melanoma conference.
My mistake the link is still working and no update yet.
Looking forward to hearing this data too. We are on the cusp of great things at Oncosec!
Oncosec website link for "current clinical trials" is unavailable right now, all other links are available.....meaning it is being updated right now. PISCES trial enrollment is most likely going to be announced any time now. I check their website daily for any changes. It is coming!
This has not been announced yet but they are definitely presenting there. Oncosec is very unpredictable with their conference announcements, so they will probably announce it any day now before the event. Cantor Fitzgerald is a nice step up from Rodman and Renshaw.
hschlauch, thankyou. If they are not targeting pd-1 failures then they are no threat to Oncosec at this point. I wasn't clear on that. I believe we are going to see nice things happening next year with the PISCES trial. Maybe we get some nice surprises too on some TAP collaboration data from Jounce or Inhibrx.
Updated interim data will be released on the current combo trial later this quarter at an upcoming melanoma conference.
hschlauch, how does Oncosec stack up against Amgen's T-Vec combo study with Merck. Punit has stated that Oncosec has the benefit of not using a virus like T-Vec therapy does. What do you think?
Deadline for Abstract submission for ASCO-SITC Clinical Immuno-Oncology Symposium January 25-27, 2018 is October 3, 2017. Updated clinical data from the current combo trial with Merck will most likely be at this event. If this data builds upon the previous positive data which obviously was good enough to earn Fast Track Designation as well as Orphan Drug status from the FDA then we should see a lot more institutional interest in the beginning of the new year. Keeping the faith here. Just a matter of time for Oncosec to get the respect they deserve. I do believe we are in for much better times here in 2018.
Any more positive data on the current combo study should help with market sentiment. The combo data from last year did in fact show that some patients took longer to show a response but did become responders after a longer treatment span. Good longer term data on the current combo study may give us an unexpected boost.
Titan, I think Punit mentioned presenting an update on the current combo trial. It will be nice to see the longer term results from that and to see if any other patients were turned into responders after a longer treatment duration.
Oncosec speaking at JNJ event today. Industry leaders are watching Oncosec. It is just a matter of time.
Did we close green today at 1.10 or red at 1.08? Looks like there was a buy at 1.10 right at 4:00.
We may see an announcement tomorrow before the weekend and mondays presentation at Rodman and Renshaw event. The last three days we have had an announcement. Hope they keep the momentum going with news of the Pisces trial open for enrollment.
Both of the new Directors seem like good fits for Oncosec. They have solid experience. Dan O'Connor may have left Advaxis because he served his purpose there and was ready to move on to a new challenge with Oncosec. I am glad he has joined Oncosec. Things are progressing nicely going into the Pisces trial.
I think we get some updates at the events this month about the current combo trial and maybe TNBC. Any news will help.
What we need now is the PR that the Pisces trial is open for enrollment. That will give us a sustainable move upwards.
I would agree with that statement. Having huge passion for the science doesn't mean you are the most qualified person to be CEO. O'Connor has the experience with big pharma licensing deals, he is the man to get the job done. I have watched Advaxis for a few years now and contemplated investing while I held Oncosec stock. That is a tough lesson. I believe Oncosec will get their turn at greatness too though. Oncosec is lining up their ducks now. Oncosec needs to execute on this window of opportunity while it is open.
This move bodes well for Oncosec if they can follow through with positive results from the Pisces trial. Any signs that point to commercial success and the stock will fly.
Daniel J. O'Connor is another strategic addition to the Oncosec board. We are on our way to a much higher market cap. It is just a matter of time. Advaxis has a few nice share runups under O'Connor. They managed a high share price of around $28. I believe with a nice licensing deal we will see a similar runup in the future with Oncosec.
Good Pisces trial results and we hit that price easy. Merck is giving Oncosec $15 million dollars worth of drug supply which means they have some faith even if the market has been brutal on Oncosec the last two years.