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It wouldn't surprise me if we got some interest from Roche.
I believe that Oncosec will easily hit the 30% BORR given the concrete results from the UCSF trial data readouts. Even if we see low partial responses in 8 of the first set of 23 patients and no complete responses we will still hit the mark. This patient population has no other alternative at this point. I also believe that with the positive UCSF trial results more patients who have failed pembro or opdivo may already be lined up to enroll in Oncosec's registration trial. I don't think we will see the trial delays that plagued Oncosec in the past.
I truly believe we are at a turning point as the registration trial opens for enrollment tomorrow. If this trial goes in the right direction and gets an FDA approval in 2nd line therapy 2019 this would lead to a 2022 FDA approval in first line combo treatment. Merck will want this company bad! Snowball effect for future indications and approvals. Combination therapy is the future and we are right in it. Hold strong and go Long shareholders! Imagine if EP-il12 became a standard of care in treatment for cancer and cancer became a manageable disease like HIV in the future. Merck would capitalize on that for sure.
Oncosec will be presenting at:
LD MICRO Invitational on June 7th 2:00 track 2
https://www.ldmicro.com/events/presenter-schedule?day=2
LD MICRO INVITATIONAL
June 6th and 7th
The 7th Annual LD Micro Invitational will highlight some of the best names in the micro-cap space. We will open on the evening of June 5th with speakers and panels (tbd). On the 6th, over 100 names will be presenting throughout the day. On the 7th, we will shake things up, with companies across three unique themes presenting: Reg A+, "The Best of Buy-Side", and "Show Me the Money" which focuses solely on names with large insider buying over the past year.
Slide Updates look good to me. They polished it up a bit, I like it. Data coming soon.
Oncosec Buy Volume looking good today going into earnings tomorrow. Would like to see some good TAP news tomorrow.
the "priming the immune system" aspect of the ep-IL12 could lead Oncosec to a one size fits all approval status maybe? and with fast track status we get more FDA interaction so maybe things speed ahead faster than expected. Hopeful thinking.
I know that Punit must be hated by investors at this point but let us hope there is method to the madness and there has actually been some way out of the box forward thinking (genius management strategy happening here) just not realized by the market yet.
I wonder if Oncosec gains an FDA approval for melanoma in combination with keytruda, this article might imply that clinical trials in solid tumors might be bypassed in the non-responder population and Oncosec could be first to market in many more indications of solid tumors....a major surprise to the market could one day be in the making here.
Oncosec will likely be riding Merck's coatails in the future with solid tumor combo therapy (for the non-responder population), that will be our niche.....unless Oncosec is bought out by Merck.
Buy volume starting to pick up here.
I don't think their price target has been unrealistic these past few years, but I think the timeline has been drawn out because of delays in patient enrollment for the combo study with Merck and UCSF. I think this registration trial will enroll quickly. TNBC trial results should be out very soon and I am looking for a nice surprise with that. I listen to all of the Oncosec conference calls and I do believe Gargosky made a mention about TNBC in the past and that they were seeing positive results but enrollment was slow. An out of the blue announcement about TNBC trial could give us the lift we need while we are waiting for combo study results. Just hoping things improve and I will continue to post any relevant information I can dig up and share here.
H.C. WAINWRIGHT THINKS ONCOSEC MEDICAL’S STOCK IS GOING TO RECOVER-price target $6
Analyst Selvaraju commented:
“We note that Merck would bear the cost of Keytruda supply, estimated at around $14M, while OncoSec is slated to fund this study with an estimated cost of $30M. The PISCES study has a two-stage design: Cohort 1 includes 23 patients, and Cohort 2 has 25 patients. The primary endpoint is the overall response rate (ORR) at 24 weeks. We believe this study should start in June 2017 and report interim data based on the first 16-20 patients in late 2017 or early 2018. Positive results from the interim analysis may allow the company to apply for Breakthrough Therapy designation in patients who have failed anti-PD-1 monotherapies.”
Oncosec will be presenting at:
LD MICRO Invitational on June 7th 2:00 track 2
https://www.ldmicro.com/events/presenter-schedule?day=2
LD MICRO INVITATIONAL
June 6th and 7th
The 7th Annual LD Micro Invitational will highlight some of the best names in the micro-cap space. We will open on the evening of June 5th with speakers and panels (tbd). On the 6th, over 100 names will be presenting throughout the day. On the 7th, we will shake things up, with companies across three unique themes presenting: Reg A+, "The Best of Buy-Side", and "Show Me the Money" which focuses solely on names with large insider buying over the past year.
IL-12 will be in the headlines more as we move ahead into the future of oncology. Inovio's work with IL-12 will draw more attention to Oncosec and what they are doing with IL-12. Melanoma is just Oncosec's foot in the door with Merck. I think TNBC will eventually be put into a combo study with pembro and ep-IL12. Merck currently has a TNBC combo study with pembro and chemo. I can imagine that the 70% non-responders to pembro in that trial may just be looking for another alternative therapy such as Oncosec's ep-IL12 with pembro. I only hope that when we get some good interim results from the new Oncosec pembro-combo study, the market reacts in a positive way with regards to the share price. The expansion possibilities with regards to the non-responder (pembro) patient population for Merck would be big.....TNBC, head and neck, NSCLC, bladder. Keytruda (pembro) just keeps rolling along with more FDA approvals. Imagine a combo study with Oncosec for each one of these indications in the future. If Oncosec gets an FDA approval in this new registration combo study with pembro that will validate the therapy and Oncosec should be revalued at a way higher share price. Just my opinion of course.
Some publicity today from INOVIO news related to Oncosec.
https://marketexclusive.com/inovios-il-12-pennvax-hiv-vaccine-combo-succeeds-can-il-12-work-cancer-vaccines/111381/
TNBC news should be out soon. June 2017 is the completion date for the trial. Maybe we see a late breaking abstract submission for ASCO. We are due for some news here. Expect something announced next week for June events.
HC Wainwright sets price target for Oncosec on 5-22-17......$6.00
wondering why a handful of large stake 13g filings from 2012 and 2013 just showed up on whale wisdom.com? Anybody know? Would this have anything to do with warrants?
The study should begin enrolling June 1st. On a positive note I believe the study will enroll patients quickly unlike the current combo trial with UCSF. The delays with the current trial are what started the long term decline in share price. There is such a large pool of non-responders to checkpoint therapy that I think enrollment for the new trial should be smoother. Fingers crossed! Added more shares today at this discounted level. I still believe in the long term value here.
Maxim Update on coverage-
How Quickly Can PISCES Rise? Aggressive or Conservative, Either Way we see Upside
The PISCES P2b study (N=48) is set to initiate in June with a protocol in place and Merck (MRK - $63.90 - NR) set to supply Keytruda. The study will enroll late-stage melanoma patients that have previously failed checkpoint therapy. The primary endpoint of the study is overall response rate (ORR) at 24 weeks.
Timelines and scenarios:
Aggressive:Oncosec'splanstousedatafromthefirst16patients(4Q17)
to approach the FDA and discuss using the total 48 patient data set to support registration, potentially as early as 2019. If successful there is more upside to our "conservative" $5 price target. Probability ~25%
Conservative:WeassumethatdatafromN=16comesin1H18asthefirst patient will be enrolled in June, enrollment takes time and the endpoint is 24 week ORR. We do believe the FDA could allow the study to be used for registration, but may require more than 48 patients as most checkpoint studies that led to approval(s), even in difficult to treat populations, enrolled hundreds of patients. As such we estimate a 2021 launch, which supports a $5 price target. Probability ~75%
Conclusion: A detailed analysis of the prior P2 data, suggest that Oncosec can be successful in Melanoma (turning cold tumors hot). We see more than one scenario in terms of timelines to the marketplace, but regardless of which scenario we select (aggressive or conservative) at the current sub-$20M valuation, success, (any scenario) is not factored into the current "distressed" valuation level.
Good data with the first 16 patients by year end and I bet we see Merck take a minority stake in Oncosec.
Maxim has reiterated their buy on Oncosec with a $5 price target.....but they are lowballing their estimates which may have something to do with price drop. They are estimating 2021 approval with a $50 million annual revenue. Previous estimates were conservative at around $200 or $300 million (may be another analyst estimate other than Maxim). I think Oncosec gets fast track approval and sees more than $50 million in revenue potential.
Todays Astrazenica lung cancer news underscores why Merck will divert more attention in the future towards promising combo therapy like the recent collaboration with Oncosec. An approval for this first joint collaboration will undoubtably lead to more combo studies with Merck to address the non-responder population in many more cancers. This is just how this has to go into the future the way I see it.
As expected today, Merck got approval for NSCLC....shares up 4 dollars after hours. I believe that when their revenues begin to increase as Keytruda brings in more money Oncosec will benefit eventually from a Merck buyout or license deal....a very big deal.
I'm not sure if they disclosed where the sites are yet. Titan may know this. The PR says Oncosec sponsored so the cost is all on Oncosec minus the drug supply. A capital raise will happen but hopefully we get positive news before year end so the raise is done at a higher price.
At present we are enduring maximum pain. Shortly, hopefully we see maximum gains when we get positive data. Enrollment in the study starts June 1st. Punit will be promoting and we will have to see what happens next. Waiting for the turnaround, I still believe it will happen.
that is just not true in my opinion.
Todays news should be put into proper perspective. The fact that Merck is definitely paying for the drug supply means that Oncosec does not need to raise capital to pay for the drug. Any capital raise in the next year will go towards padding the books and Oncosec will continue to trade at cash value, a big undervaluation by the market. Any positive news with the first cohort of patients by year end will have the share price moving up much higher. We just need good trial results. Good data is all that will really matter in the end here.
They would be even better for Merck if they outright owned Oncosec's platform.
Be on the lookout for a Merck announcement at 4:00 today about NSCLC approval in first line treatment. When Merck knows for sure they have more money under their belt coming in the next year they may be more likely to throw money at small caps like Oncosec.
On a positive note Oncosec news today is showing up under Merck news feed on Scottrade. I don't recall Oncosec news ever showing up under Merck's news feed, only Oncosec's. My opinion is that Merck is not jumping out of the gate and announcing this combo trial as the next cure for cancer for non-responders because if this trial does succeed this will be a big deal. Merck probably would like to see Oncosec share price stay low so they can get a better deal later on when partnership happens, or buyout. The fact that Merck is supplying the Keytruda (which everybody knew this of course) means that this will belong to Merck eventually, just a matter of at what price......if the trial succeeds. I believe that Oncosec will get approval and we will be happy in the end.
Thanks for clarifying that Titan. I didn't realize I was looking at the German Merck site. Is their a listing for the American Merck venture holdings anywhere. I would like to see that.
Titan, if Merck was funding Oncosec through their Merck Research Venture Fund I don't see Oncosec listed in the fund holdings. Would they be permitted to keep the holding confidential? I hope you are right.
http://merck-ventures.com/portfolio
I am even more surprised that Merck isn't outright offering upfront money to Oncosec at this point for exclusivity rights. 50 to 100 million dollars at this point is a small drop in the bucket for them. If all goes well with the PISCES trial Merck will be paying a hefty sum indeed. I am surprised the market is still undervaluing Oncosec given the fact that the PISCES trial will be on track to be the first approved combo therapy in the non-responder population to keytruda and opdivo. Boggles the mind. This could be absolutely huge for Merck and Oncosec.
Massive market switch between Merck and Bristol was a big surprise and Keytruda is definitely Merck's best growth driver going forward. They will need to exploit every option. Bristol should be doing the same thing. We shall see. Real dogfight there.
I don't know about that but I do know that things will start to get very interesting if we see any response in the first cohort of patients enrolling in the new ONCS combo study. Start date is one month away. This summer will hopefully be the springboard for a higher share price....let's hope.
I am going to speculate and wonder what BMS might do when Merck gets Keytruda first line therapy approval for NSCLC....which should be coming in the next 10 days or so. Maybe BMS would be interested in approaching ONCS to do a combo with Opdivo for NSCLC. That would be interesting. Just speculating what Bristol's next move will be to counter Merck's recent move ahead of them in NSCLC. BMS has a collaboration with HTBX as does ONCS, so we are certainly on their radar with regards to combo therapy.
The World Congress 2017 is in Philly where I live. Only wish it wasn't expensive to go. I would love to hear Dr. Pierce give his presentation.
Believe me I wish that Bristol Myers was equally interested in Oncosec and doing a combo study like the combo study with Merck.