Oncolytics Biotech Inc T.ONC

A/O Sept. 08th ONCY's cash runway is until late Q4, 2024

[Noteable]

PanCan will assume 50% of ONCY's Phase 3 metastatic pancreatic cancer study through their Precision Promise program. With ONCY's commitment of US$10 million (C$13.5 million) towards the Phase3 mPC PanCan collaborative study costs and C$0.5 million towards ONCY's Phase 3 metastatic breast cancer study, as of September 08, 2023 ONCY would effectively have C$28  million remaining (C$41.8 - C$14 million) in R&D and operational cash reserves.

Considering that ONCY's Phase 3 clinical expenses are outlined in the above, ONCY's quarterly expenses should fall proportionately to around C$6 million per quarter, as occurred in 2022,  resulting in a cash reserve and operational runway lasting until late Q4, 2024.

[JohnnyYeg]

And what are the chances that with ONCY running two P3s that have shown success and efficacy to this point in former trials, that they actually see the end of Q4 as ONCY and "cash runway" remains a concern?? 

[venture009]

ONCY doesn't have the expertise to run two PIII trials. The investment community recognize this and will punish the sp if they attempt to go alone. They have relied exclusively on 3rd parties to define how pela works. Trying to run two PIII trials would be the worse possible of option. 

[Noteable]

The chances that ONCY will be running two P3s would be dramatically reduced should ONCY be acquired by then.

[Noteable]

The IRA, which was passed late last year, and the FDAs 13 years of market exclusivity for newly approved novel biological drugs, which starts on the day of FDA market approval is granted, give ONCY a further advantage as a potential acquisition target.

[Noteable]

ONCY and PanCan would be astute to expeditiously file for an Accelerated Approval for pelareorep soon after the P3 pancreatic cancer study is submitted.

[Noteable]

Should read : .... soon after the P3 pancreatic cancer study is started.

[pelaboost]

@Noteable. I agree with your numbers. I do not see the financial position as one of strength. One can only hope that the recent financing was a step with some serious method behind it. I am hoping for the best, and recognize we have a few at head office with financial acumen. Still, this is not a slam dunk.

[Noteable]

Yes, one can only hope that the recent financing was a step with some serious method behind it, like an acquisition.

[pelaboost]

@Noteable. Yes, agreed, acquisition. That thinking, acquisition, could take many forms. Hopefully some clarity on that soon, and even though acquisition is a no brainer, one does not know what the Brain Trust has in mind. IRA, very good point. Accelerated Approval  - I was the one that dug up AA several months ago. So let me ask this question. Is it possible that AA has been applied for? If I

[Noteable]

 Is it possible that AA has been applied for? good question. Possibly since ONCY previoulsy treated approximately 128 pancreatic cancer patients. Current law allows for a drug to be approved under this pathway if it treats a serious condition and fills an unmet medical need on a surrogate or intermediate clinical endpoint. Simply put, rather than having to show that patients live

[Noteable]

The Phase 2 GOBLET-1 study also trialed a pancreatic cancer cohort. Goblet could be the basis of an Accelerated Approval filing with the FDA and the Phase 3 PanCan clinical study would serve as the confirmatory study that FDA would then check off as the met requirement in their accelerated approval of pelareorep in this indication.

[Noteable]

Pancreatic cancer is considered a rare disease with an unmet treatment need, so therefore a randomized Phase 3 may be run with between 80 to 120 patients divided equally into 2 cohorts. The trial costs are approximately US$41K per patient. Therefore, a 120 patient Phase 3 trial would cost around US$4.9 Million while an 80 patient trial would cost approximately US$3.2 Million. With PanCan

[pelaboost]

The following is not Oncolytics Biotech. I do not want to get hopes up, especially my own, but there is some history. Search  -  Another FDA Treatment Approval Underscores Promise of Precision Medicine. Cheers

[Noteable]

https://pancan.org/news/another-fda-treatment-approval-underscores-promise-of-precision-medicine/#:~:text=The%20FDA%20recently%20granted%20accelerated,based%20on%20their%20tumor's%20biology.

[Noteable]

Eli Lilly and Company (NYSE: LLY) announced that the  approval of Retevmo® (selpercatinib, 40 mg & 80 mg capsules) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment was approved under accelerated approval based on ORR and duration of response (DOR

[Noteable]

Retevmo was approved on data collected from 41 treated patients. RET Fusion-Positive Solid Tumors   No. of patients   41   Overall Response Rate1 (95% CI)   44 %(28, 60)   Complete response   4.9 %   Partial response   39 %   Duration of Response     Median in months (95% CI)   24.5 (9.2

[13X2413]

Interesting and informative. Does this have any bearing on the future of Onc or are you just educating everyone on medical science?

[Noteable]

Let's see .. didn't someone just buy US$ 17.5 million of ONCY stock in the last 30 days? 

[Azzak34]

My favorite parts were points 6 and 7 where Quento complained there weren't participants in any trial to show significance then completely contradicted himself and said there were! Haha.  And to your point Noteable, a healthcare investor just bought $15 mmillion worth of shares then bought AND exercised $2.25 millions worth of options. 

[Noteable]

And of course, both Quentin30 and the Seekingalpha paid  ghost writer conveniently "forgot" to mention the recent US$17.5 million investment in ONCY  - which again points to their obvioys duplicity here.

[inthno]

Just a quick note. I really did not like the seeking alpha article but they did mention the recent financing. ONCY bolstered their cash funds at the end of July with a $15 million deal for shares and warrants, the latter at an exercise price of $2.81 for 60 months. Exercising their over-allotment option yielded another $2.25 million. At this burn rate, with the extra money in the tank, this

[Noteable]

Well I suppose they did mention the US$17.5 million stock purhcase but here is their assessment and no mention of PanCan. At this burn rate, with the extra money in the tank, this means that ONCY will be able to sustain operations for 5 to 6 more quarters. And yes, for pancreatic cancer a 69% response rate not only sounds but is great, which is why PanCan

[inthno]

Poorly written article but they did mention pan can....it was the paragraph before the financials. The combination was also selected for inclusion in the Precision Promise study, which is assessing various treatment approaches for pancreatic cancer.

[Noteable]

As for Pelareorep in breast cancer, the SeekingAlpha ghost writer had the temerity in trying to criticize the findings of PrECOG, a not-for-profit cancer research group formed to  to support the overall purpose of the ECOG-ACRIN Cancer Research Group,  who in their own are a scientific organization that

[Noteable]

Did I forget to mention that the SeekingAlpha ghost writer was a paid hack contributor.

[Noteable]

The SeekingAlpha paid hack ghost writer made no mention of PanCan. Just a passing reference to the Precision Promise study. Obviously an uninformed writer with a superficial understanding of the events and the company.

[Azzak34]

They didn't mention the healthcare institution that bought the shared. He was building a case for refinancing and splits, not that someone from an institution forked out 15 million. And Pancan picking us for an expedited trial.  Glaring omissions that show this was a hit piece. 

[Noteable]

As of June 30, 2023, the Company reported $24.4 million in cash, cash equivalents, and marketable securities, then successfully closed a US$15 million public offering on August 8, 2023. On a pro forma basis, including the estimated US$13.6 million in net proceeds from the public offering, the Company's cash, cash equivalents and marketable securities would have been approximately $42.7 million