Red Flags to ConsiderImaginations have been running rampant on this board for quite some time now... lots of speculations about buy out price, predicted sales revenue. etc etc. so thought I'd pose some questions for those with active minds and who would like to engage. Bear with me.. Here's what the CEO of Adlai Nortye had to say in 2017.
"With its impressive clinical data coupled with its unique and novel mechanism, REOLYSIN will be an instrumental component in furthering the development of our oncology pipeline, it immediately makes Adlai Nortye a late stage biotechnology company and REOLYSIN itself becomes our lead product. Given its potential in multiple oncological indications and its ability to be used in combination with multiple chemotherapies and immunotherapies, REOLYSIN will help to broaden future therapies made available by Adlai Nortye and advance us towards commercialization."
Here's their website, go check out their pipeline: Platform (adlainortye.com) So cue the question, "why do they no longer list Pelareorep in their pipeline, if the bridging data is so meaningful..?" Ok, I'd like to address a point made often by Canadafan too, that these large pharma companies do a lot of DD before committing their good name to a trial with Pela.
hmmm, yah, you'd think so wouldn't you... DD perhaps in the same way that GM partnered with Nikola.? Or the same way that Merck's Keytruda was used in combination with 4D Pharma's MRx0518, or EMD Serono co-trialling MRx0518 with Bavencio... 4D Pharma filing for bankruptcy last year... ooops
The data room at Oncolytics has been open for years... there has been no deal to date of any significance... The AN deal was signed more than 5 years ago, they could have run the Phase III by now, even if just in China. The bridging trial data looks extremely encouraging. For over ten years all ONCY management have ever spoken about is finding the right partner. My point is, ONCY is just one of many companies that Big Pharma are looking at. And just because we are co-paying trials with some of them, does not make it special or unique. A question of honesty.
Another question, why didn't ONCY simply re-run the H&N trial, after Brad said they would ? What about the seamless transition to a Phase III for invasive bladder cancer he spoke about in 2016... Ok, so Brad lied (a lot) and was finally pushed from the company, but are we confident in what Matt tells us... "Roche just needs the data from Aware-1 to pull the trigger..." or, "Aware-1 will complete in a few months". Or telling us in a fireside chat in 2020 that he anticipated being on the market in 2024... come on, the phase III will take 3 years minimum... what is he smoking?
None of us on this board even knows for sure that Pela + Pax + CPI is even any better than Pela + Pax alone. Every, and I really mean every damned trial end date has been missed. Who here, will hang on another six months, if we get to June and ONCY says... "patients just keep living longer and longer, so we'll publish result now by year end 2023".
Question, Who is prepared to continue holding ? By June we will need more cash to keep the lights on (well to have that magical 12 months runway)... over 26 years, that need has meant just one thing, stock dilution.
Ok, who wants a ray of hope..? IF the recent Panc data show durability then FDA might consider the use of biomarkers as surrogate end-points to justify an accelerated approval pathway... i.e. running the trial in real time whilst on the market, and reassessing the efficacy:risk ratio each year to maintain the licence.
If the bracelet data is not as strong for mBC then it's likely to follow a traditional Phase III, so approval by 2028/29. No matter, here's some math (using values found from Google).
A single 200-mg intravenous dose of Bavencio costs $1098. The standard dosage is: - 10 mg/kg (mg per kg of body weight) as an intrav. infusion over 60 min every 2 weeks
Assuming the average (US) female patient weighs 70kg (actually Google reckions it's 77kg, but I'm being especially kind) the cost per annum would be :
4 vials (you can't have 3.5)* $1098 * 26 treatments = $114,000
Now the question becomes, how much can ONCY charge for co-adminstering Pelareorep. (yah I know, they wouldn't be on the same day). This will clearly depend on how MUCH better Pela + Pax + Bavencio is compared to Pela +Pax alone. Annual treatment is already 114k, so there's no way they can cost it equally. I would expect it to be between 10-15k.
From ONCY's own figures from their current presentation, Drug Treatable HR+ / HER2- Breast Cancer Cases in Major Markets will rise to 300,000 by 2028 (when ONCY may, MAY be approved via a traditional PIII). Now if ONCY were able to treat all 300k patients at 10k per year, with this combo, it'd be worth a cool 4.5 billion dollars... but let's be realistic here, you don't get 100% market share at launch and not all insurance plans will cover it. So assume 10% penetration, that's still $450 million revenue.
Applying a PE of 20, this would value ONCY at wow, would ya look at that, $9 billion..!! Are the pumpers right then ?
Note: Bavencio is currently approved for the treatment of patients with metastatic Merkel cell carcinoma (MCC); patients with advanced or metastatic urothelial carcinoma; and in combination with axitinib for patients with advanced renal cell carcinoma.
So there are red flags aplenty, a history of disappointment, delayed timelines and outright lies, but should Bracelet-1 actually show unassailable, significant improvement over Pela + Pax alone, then things could get very interesting. If there is no improvement then ONCY will drop mBC and suddenly become a Pancreatic cancer company instead, with a second (and truly final) shot at goal.
Oops, red flag. Now if I were an exec at ONCY, I'd have been filling my boots with stock... so why haven't they.?
I'm holding till June. and I truly hope that a deal is done... and wouldn't it be nice for eligible patients to be given renewed hope.
Some comments up there for those who think I'm a basher, and some who only see unicorns and rainbows.
GLTA