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I believe this will be market moving data tomorrow. More supportive Biomarker data will definitely create more positive sentiment towards the PISCES trial.
I wouldn't worry too much right here. We are definitely in the midst of a major trend shift from negative to positive which will coincide with upcoming data release. Oncosec will be presenting at conferences in the new year and as we get closer to mid year 2018 PISCES data we are very likely to get significant runups in anticipation of success. If the path undeniably points to an FDA approval (AA) next year this stock will hit $5 or $6 easy....and then breakout much higher from there. I would also add that Oncosec is in the right place at the right time if we see an overall market breakout much higher next year. Great data and a positive market could be the right combination to set us off on a parabolic move higher. Fact is that Biotech moves like that at the right time and place.....and then you gotta sell on that move.
Very Curious that the Collaborators links on Oncosec's website have been cleared for the past week. They may be waiting for the release of data at SITC before updating this info. I noticed that before they totally cleared the page, Merck was the only collaborator listed....Heat Biologics and Plexxicon were removed. Maybe that was too much of a giveaway before upcoming data releases.
We should get a helpful boost thursday with supportive data coming out from the 2nd Annual Biomarkers & Precision Medicine USA Congress. Any positive data relating to the biomarker testing from the monotherapy and combo therapy trials should be very supportive of the PIECES trial.
Well if you wait a little longer for a new CEO at Oncosec, the new CEO will be Ken Frazier when the Merck buyout happens.
Nothing wrong with being positive about ground-breaking data that could turn out to be financially lucrative for Oncosec and shareholders. If they can show they actually do have another iron in the fire (with regards to the multi-gene construct) besides the current PISCES trial, then Oncosec could see their shares re-rated rather quickly right here.
I like this ATM offering in that if they time this well with a share price runup on any good news coming up.....next week is the 9th World Congress of Melanoma, then in November we have SITC data release from 2 abstracts.... they will be selling fewer shares at higher prices....and soften the dilution. I still think the market is underestimating the news at SITC. This could spark a higher than expected share increase in the short-term.....like get us back between $2 to $3 quickly. The share price has been rising 10% per day for the last few sessions and we are moving through resistance levels....so we could see a sharp move up soon.
Oncosec already announced a stock ATM filing over a month ago to raise up to $8.4 million(at the market sales from time to time to limit the dilution, and probably at higher prices, so less shares offered):
"This prospectus supplement and the accompanying base prospectus relate to the offer and sale by us of up to $8,400,000 of our common stock. Our common stock will be offered over a period of time and from time to time through or to Oppenheimer & Co. Inc. (“Oppenheimer”), acting as our sales agent or principal, in accordance with the terms of the equity distribution agreement we have entered into with Oppenheimer. We are not required to request any sales under the equity distribution agreement, and Oppenheimer is not required to sell any specific number or dollar amount of shares under the equity distribution agreement.
Sales of our common stock, if any, under this prospectus supplement and the accompanying base prospectus may be made by any method deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly on or through the NASDAQ Capital Market, sales made to or through a market maker other than on an exchange or otherwise, and in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices. There is no arrangement for funds to be received in any escrow, trust or similar arrangement. See “Plan of Distribution” on page S-11.
Oppenheimer will be entitled to compensation at a fixed commission rate of 2.5% of the gross proceeds from the sale of shares of our common stock through it as sales agent under the equity distribution agreement. Under the equity distribution agreement, we may also sell shares of common stock to Oppenheimer, as principal for its own account, at a price to be agreed upon at the time of sale.
In connection with the sale of common stock on our behalf, Oppenheimer will be deemed to be an “underwriter” within the meaning of the Securities Act, and the compensation paid to Oppenheimer will be deemed to be underwriting commissions or discounts."
Lasers, I have been watching Oncosec for about 5 years now. I am by no means a science expert, I just believe in this company.....I am a cheerleader for the vision they are pursuing.
hchlauch quote below explains more about the multi-gene construct in case you missed this.
"Yes, it would be a proof of concept for a platform that could theoretically be an easy plug and play based on biomarkers. The various gene combinations would be virtually limitless, cheaper and easier to produce, safer because the proteins aren't expressed systemically, and more effective when expressed intratumorally. Achieving in-situ vaccination locally allows for an abscopal effect that seeks and destroys distant cancer cells/tumors expressing matching antigens. Systemic anti-PD-1 would still need to be employed due to the exhausted t-cell phenotypes present in mets, but that too could be accomplished through intramuscular electroporation of a plasmid encoding the PD-1 antibody.
We know IL-12 will continue to be the backbone of any multigene product, but imagine if they can demonstrate the successful expression of multiple genes simultaneously and intratumorally. There are probably hundreds of companies, both small and mega cap, designing individual recombinant proteins, to be used mostly in combinations with recombinant checkpoint inhibitors. Oncosec may be able to combine any of these protein targets into a single plasmid product, which would otherwise be highly toxic when delivered systemically as a recombinant protein package.
Oncosec's multigene constructs would be too disruptive to ignore. Next month's presentation is not just about a single new product being tested in mice; it will be more about the proof of concept for a technological innovation that will disrupt the way immunotherapies are administered and produced."
Yes, this is the abstract for the multi-gene construct. This will be the first data release on this. Even though this is a mouse study, if it shows solid proof of concept than this could be very important data that the market has not anticipated from Oncosec while all eyes have been solidly on the Merck combo trial. It is a late-breaking abstract so it should be interesting data as Punit has implied. This is icing on the cake and we should see some stock price movement on this leading up to next month.
Recent quote from Punit on twitter sounds pretty confident about the multi-gene construct data to be presented next month at SITC:
"Also, preclinical data will show PIIM construct as true differentiator in I-O, by expressing multiple gene targets on one vector"
Expect Oncosec to put out PISCES data mid 2018, let there be no doubt about that. It has been stated over and over again.
SITC update on current combo trial with Merck will be next month and and PISCES data release will be mid-2018.
Both updates are listed on biopharmacatalyst.com
https://www.biopharmcatalyst.com/calendars/fda-calendar
Many eyes are now watching Oncosec more closely, so don't expect the stock to start rolling over already. We may see much greater gains leading up to data release mid-2018.
Another difference between Oncosec and Inovio is that Oncosec invested millions of dollars with REV1 to advance their electroporation delivery technology so they can administer the therapy to deep solid tumors, not just surface skin melanomas. They appear to be the leader in the electroporation field with this newer advanced technology.
http://rev1engineering.com
Not too late to join the party here. We are making a solid move higher this morning on high volume. This has been slowly building the last few days.
More than mouse studies going on here friend. They have a chance at an accelerated approval for their combination study with Merck next year (PISCES).
I think we will see the price move up into next weeks data release on the multi-gene construct. hschlauch has pointed out how disruptive this data might be. Let's see how the market reacts.
This sounds like an extremely disruptive breakthrough for Oncosec. So far the market has been uninterested in the "talk" of a multi-gene construct. Lets hope the actual data shakes the market up when it comes out next month. This is exactly the type of news we need to get the recovery ball rolling here. Thanks for elaborating on this hschlauch.
The abstract for the multi-gene construct at SITC next month is titled "Intratumoral administration of a multigene construct by electroporation can effectively modulate anti-tumor response in a murine B16.F10 model"
....being as this is a mouse study do you think positive results which are implied by the abstract title is enough to move the needle at this early stage. I really hope this additional data on top of the current combo study update will finally get a lot more institutions to jump on board here.... and instill more confidence in the stock.
Those numbers reiterate why Oncosec is a strong buy. If their therapy has a 33.5% BORR as monotherapy and the bar they need to cross for an FDA approval in the PISCES combo trial is 30% BORR, then even without the addition of Keytruda they should be able to surpass that mark. The addition of Keytruda improves upon the already established data of Oncosec ep-il12. When the FDA grants Oncosec accelerated approval next year, I would not be surprised if eventually the longer-term follow up data gets them a first-line approval in melanoma. The combo study with Merck for the non-responder population in checkpoint therapy is our quickest route to commercialization and that is why they chose it.
Might hear more info later today; I think they are releasing quarterly report after the bell today.
BARCHART.COM technicals for Oncosec have definitely improved: we are sitting above previous resistance levels right here. We should be moving higher soon.
https://www.barchart.com/stocks/quotes/ONCS/opinion
Investors should keep in mind that Oncosec could be executing the ATM right now taking advantage of the upward price movement. The move above the $1 mark should keep the market fears of delisting at bay. Quiet capital raising right now will make this a smoother ride into next year if that is what is happening right now. In any case we are looking good into the SITC data next month.
It is definitely time to step up the ladder here.
I am not a big fan of Sabby, they have been in and out of Oncosec for many years. That is why I would keep an eye out for the next update to institutional holders to see if we get any reputable holders other than Vanguard. I would love to see Baker Brothers get into this or the new LONCAR immunotherapy index taking an interest.
We are seeing massive volume here. Keep an eye on the next quarter SEC stock holdings filings. I am sure Institutions are loading up here.
Oncosec has had a stellar balance sheet for years, lots of cash and no debt at all. They have enough money now to hold them over to the significant data release next year. They are trying to avoid dilution right now. There is an ATM in place to sell stock on the open market to avoid dilution. Any positive upcoming news at SITC or Melanoma conferences in the next few months will help us through this period if they decide to tap the ATM before next year. We are in good shape here.
We might have a 5 or 6 million volume day tomorrow....I hope! More eyes on Oncosec!
The market was simply waiting for a clue as to where the PISCES trial might take Oncosec, and I think we just got a taste of what is likely going to be a nice run up to the SITC data release.
There is no candy-coating that this stock has been anything but horrible the past few years even in the face of good data presentations......but now we have a defined, concrete, path to commercial success if Oncosec puts out good data next year. Holding Strong!
Oncosec will be at: 9th World Congress of Melanoma
9th Annual World Congress of Melanoma – A Joint Meeting with the Society of Melanoma Research| October 18-21, 2017
Brisbane, Australia
https://worldmelanoma2017.com
Oncosec also spoke at the 2nd Annual Biomarkers and Precision Medicine USA Congress.....I think it was today.....and that may have coincided with the abstract release. Maybe more conclusive information on the biomarker testing has convinced the market of it's validity.....which definitely bodes well for the PISCES trial.
The market was underwhelmed when data was released on the current combo study last year because of the use of a bio-marker test to screen the patients. From what I read the scientists had complete faith in the testing which in my mind means that most of the people who responded to treatment were 100% not likely to respond to checkpoint therapy alone. That means that the patient population in the current combo trial with Merck is highly likely to be the same patient population in the PISCES trial and we will likely see similar response rates above 33%. When that happens our share price will explode.....and as Punit just mentioned again today......interim results mid 2018......not the misconceived 2020 date on the clinical trials site. I am still a strong believer here.
I would hold for a much higher share price. SITC would not be highlighting Oncosec in a late breaking abstract of it's current combo trial if it was not positive data which builds on the previously released trial data. This sets the stage for very good results in the PISCES trial next year. The real question about the current combo trial is how reliable the bio-marker tests were in choosing the patients for the trial. According to the scientists involved the bio-markers tests are highly reliable....and if that is the case, the PISCES trial will be a huge success.....and you will make a hell of a lot more money holding your 200,000 share a bit longer.
A nice double shot of news. Will be exciting to see the multi-gene data....the market seems excited too. Just what we needed around here.
Jeff, would you post the abstracts, I am not seeing a list yet. Hopefully this pop will stick.
The movie 2012 comes to mind......worldwide calamity.......Oncosec would cease to exist if this trial is dead on arrival next year.....it would be over for them. That is why Punit was very clear about the magnitude of the situation next year. Interim results on the PISCES trial next year will be a "card flip, binary event"....meaning it is all or nothing. Remember though, the bar is set low for the first set of 23. They only need 4 patients to show a response to be able to go on and enroll the second group of 25 patients. That is a19% response rate. Ideally we want to see 30% but the 19% threshold will keep the trial moving ahead for full enrollment.
The Core study phase for the PISCES trial will be 24 weeks, then an extension phase and long-term safety follow-up (2 years). We will have interim results from the initial core study in 6 to 9 months. This is not the time to be fooled out of your shares investors. The time to sell would be next year if Oncosec reports no response rate in the first set of patients in the PISCES trial. If we get a 30% response rate we will be in great shape moving forward.
I think any positive interim results next year and we will see an Oncosec/Merck deal like the Kalvista/Merck deal announced today. We just need more proof to lock Merck in.
According to Punit interim data can be released as early as mid 2018 for the possibility of an accelerated approval while the trial would be ongoing. I think the market is overreacting today based on the 2020 date on clinicaltrials site. I think it is an excuse for a shakeout here to make people sell their shares.
Merck presented positive results at the ASCO 2017 meeting this year in TNBC study with a 60% response rate. The non-responder population for TNBC is 95%. That is a large market for Merck and Oncosec to explore in a combo study if Oncosec releases positive results from their current TNBC trial which we should get some data on very soon...even if it is based on a few patients it opens up the possibility of a combo trial with Merck.
Here is the link to the Merck article on TNBC at ASCO:
https://sciencelife.uchospitals.edu/2017/06/05/immunotherapy-drug-effective-in-triple-negative-breast-cancer/
Not paid promotion at all:
https://www.gurufocus.com/news/518583/merck-collaborates-with-oncosec-medical-to-unlock-untapped-market-for-keytruda-
Also the market value suggested in the article is $460 million dollars annualy. Divide 460 million by 22 million outstanding share and you get roughly a $21 share price right off the bat if Oncosec hits the 30% response rate. I would bet that Oncosec will get a lot of share price upgrades on good news next year.