Oncolytics Biotech Inc T.ONC

Canaccord Fireside Chat & pelareorep's approval in mBC

[Noteable]

If anyone cares to listen to the call, Matt Coffey clearly states at timestamp 23:10 that ONCY has 2 randomized clinical studies woth pelareorep + pacilitaxel (IND-213 & Bracelet-1) that were both ststistically significant and the ONCY thinks that this is the path to pelareorep's enhanced approval.

And in terms of life-cycle management Coffey ststed that ONCY should also be looking at combinations with ADCs and and CDK4/6 inhibitors. And "by all means ONCY will be looking at combinations with ADCs" - which brings Pfizer back into the picture, alongside Roche, Merck, and other companies with ADCs either on the market or in development.

Futhermore, the AWARE-1 study in brand new mBC patients showed that combination of pelareorep + Tecentriq resulted in a "phenominal increase" in CellTiL  which gives a better benefit in overall survival (OS) and that the earlier one can use the pelareorep/Tecentriq combination in mBC patients, the better the benefit that would be dervived. 

Lastly at timestamp 24:20 Kirl Look commented on the US15 Million Offering and what was particular "exciting" was that this was the first time that a "strategic helathcare investor" was involved in an ONCY offering and also took a "sizable portion of that raise". He went on to say "That was the first time that we saw that type of interest coming our way and in a pretty tough financing market". Look then stated that ONCY was pleased with that outcome and feel confident in ONCY's funding that will take the company beyond 12 months and the company can "getting moving on the Precision Promise opportunity" and continue to push the breast cancer opportunity forward, as Matt discussed."

In short, ONCY will be seeking to achieve the quick approval of pelareorep in the treatment of ER+/HER2- mBC in combination with paclitaxel, soon after the company files for an adaptive  Phase 3 study that would include the 2 completed Phase 1/2 mBC studies that were statstically signficant and which achieved the FDA's asks, as earlier discussed.

[Noteable]

Excuse the lack of spell-check in the previous post.

[Angler101]

Lol.....that's ok Note....we forgive you....thanks  for all you do here!...

[Angler101]

I found it encouraging that somebody bought about 35,000 shares in the last 20 minutes of trading.....on a Friday....just sayin...

[Goldnboy1]

And did you know that same house was dumping stock in advance of that horribly discounted PP. Seems Morgan Stanley may have an inside track here. Bulllllish!!

[fox7mf]

Very interesting Goldnboy. I too remain bullish, just no longer sure of how soon we can expect that oft mentioned $10b +. I'd take $2b for a little clarity tomorrow. GL all!!

[homestand]

20 seconds

[Noteable]

In December 2021 the following was posted:  ... Ongoing challenges with ADCs include improving target specificity, optimizing the toxicity profile, and identifying biomarkers for patient selection.ONCY has been addressing the above challenges through pelareorep's clinical development plan that includes the AWARE-1 WOO study. https://stockhouse.com/companies/bullboard/t.onc/?threadid

[Noteable]

Listen to the archived webcast carefully since an acquisition may not be as far as some may wrongly think. 

[Noteable]

Both Matt and Kirk spoke to the prospect of moving pelareorep into Phase 3 trials in both breast and pancreatic cancer. Listen to the archived webcast at the timestamps that I referenced. The Phase 3 in metastatic breast cancer would be with the doublet of pelareorep + paclitaxel, which corresponds to ONCY's IND-213 and BRACELET-1 response findings. Furthermore the US$ 10 Billion acquisition

[Noteable]

Not only can ONCY be potentially be combined with CDK4/6 and checkpoint inhibitors, CAR-T therapy, bispecifics, chemotherapy and small molecules but now also with antibody drug conjugates (ADCs) which collectively  justifies an ONCY  US$ 10+ Billion acquisition value.

[itntdf]

just got up to around the 14 minute mark on the webcast which i would characterize as a WTF moment. while kirk look said a contract was in place at the 12:27 mark, he went on to say the details of "an agreement" were expected to be completed in the aug/sept timeframe. when questioned on the specifics of the pancan collaboration, he said the pancan was a "plug and play" model

[westcoast1000]

ithntdf, I heard all that as well. I do not think he would make a mistake on the dates. Presumably the first 80 are part of the total 180.  We all hope the company is aquired before 2025.

[fox7mf]

We all hope Oncy is acquired before 2024...before ESMO...next Friday:)

[Noteable]

Acquisition before or in 2024? Precisely. And PanCan driven.

[Noteable]

Should read ... Phase 3 PanCan and metastatic breast cancer driven.

[Noteable]

Both Phase 3 clinical trials can benefit from the FDA's enhanced Accelerated Approval process and the Precision Pathways Act that provide for the quick and early approval of drugs based on surrogate endpoints like ORR and PFS. These surrogates are later validated post approval, with long term OS data that is collected from the Phase 3 clinical study that is run concurrently while the drug'

[Quentin30]

No, Matt has stated before that for mBC they would be following a traditional approval route. ONCY to the best of my knowledge has NEVER mentioned accelerated approval... Thinking this to be the case is hopium... The two Phase IIIs look set to follow the traditional path, treat, analyse, submit... Unless of course, they can correclate their biomarker(s) to a surrogate end point, but I don't

[Buckhenry]

Let's all hope that as I would like to not see another worthless post from the dreamers section.  I think their motto should be.... even a blind squirrel finds a nut every once in a while. 

[Buckhenry]

If it was not for Google searches and copy and paste.... the dreamers would have nothing to say.  Has the outcome thus far been impacted by anything that the dreamers have posted over and over here?  I guess each one will have to answer that on their own. In the mean time we wait. We all seek a similar outcome... the difference is dreaming versus a realistic approach.