Oncolytics Biotech Inc T.ONC

ONCY's pelareorep is now Phase 3-ready

[Noteable]

June 05, 2023 -  Oncolytics' HR+/HER2- breast cancer program now phase 3-ready and advancing to a registrational study of pelareorep-paclitaxel combination

https://www.oncolyticsbiotech.com/press-releases/detail/601/oncolytics-biotech-announces-updated-randomized-phase-2

[Noteable]

Toxicities seen in the Phase 2 Bracelet-1 study were primarily caused by the increase in taxane - paclitaxel dosing.

[Noteable]

Dr. Martine J. Piccart, M.D., Ph.D stated that a two-arm registration study in metastatic breast cancer is more practical and less expensive than a three arm study which would otherwise include an immune checkpoint inhibitor. Having pelareorep approved for metastatic breast cancer with paclitaxel would also offer the treatment to a wider base of breast cancer patients than otherwise.

[Noteable]

Dr. Piccart also commented on pelareorep + paclitaxel's combination scoring high on the ESMO - Magnitude of Clinical Benefit Scale. https://www.esmo.org/guidelines/esmo-mcbs/about-the-esmo-mcbs ESMO-MCBS was developed in 2015 as a validated and reproducible scale that is applicable across the full range of solid tumours and since 2023 in hematological malignancies. The latter has been

[Noteable]

Now that a two-arm Phase 3 has been determined, Adlai Nortye's US$85 million to support the Phase 3 costs will come into the picture, with or without ONCY.

[Noteable]

Enough said ! Phase 3 is next.

[Noteable]

Enough said ... 

[Noteable]

Big Pharma and the FDA see the potential pricing of the novel biologic in pelareorep (as a candidate for 13 years of FDA market excluivity) in combination with the generic paclitaxel as a very favorable value proposition, which should result in a rapid marketing approval for an unmet medical need in HR+/HER2 negative breast cancer and therefore a quick follow-on market penetration in this and

[Noteable]

The pelareorep + paclitaxel doublet favorable price point and an exceptional PFS and HR improvement over SOC (paclitaxel) should result in the FDA and EMA granting pelareorep a rapid approval.

[Noteable]

Repost - "The pelareorep + paclitaxel doublet favorable price point and an exceptional PFS and HR improvement over SOC (paclitaxel) should result in the FDA and EMA granting pelareorep a rapid (accelerated) approval."  

[Quentin30]

RAPID approval..?? Approval is at least 4 years away... Thy have to START a phase III first, and NO pharma company big or small has come forward to offer to pay for said imaginary trial. It won't happen, because there are NO partners interested, and it has always been thus.. you are dangerous to the uninitiated... pumping this old dog as though it was a done deal...  sad

[Noteable]

Given that pelareorep has demonstrated single agent anti-cancer activity in a well controlled and randomized Phase 2 clinical study, multiple Big Pharma companies are seeing of the significantly positive results from this late-stage clinical study. And late-stage biotech companies with novel biological cancer therapies are what Big Pharma are "paying up for", particularly now that the

[fox7mf]

 Bay Bridge Bio values ph3 ready biotechs at $1.248b usd. Times that by 2 for PDAC.. Oncy should presently have a market cap in the neighborhood of $2.5b usd. Let's get rid of the market disconnect!!

[Noteable]

"Bay Bridge Bio values ph3 ready biotechs at $1.248b usd" - Perhaps however Bay Bridge's valuation models cheaper small molecule pharmaceuticals (chemistry derived) and does not particularly address the oncology market. Instead Bay Bridge Bio's model has taken a 'shotgun" approach that includes all small molecule drugs in all disease states, even where M&A activity

[fox7mf]

I think what Bay Bridge suggests is a minimum and definitely not a buyout price. Give Oncy that $1.248b valuation × 3 (mBC, PFAC,CRC) and that brings us to about $53usd per share (fully diluted.) Factor in a 100-200% premium and there's your b/o price.

[Noteable]

Bay Bridge Bio's valuation model is significantly flawed, given that it does not use real world evidence in the oncology market space.

[Noteable]

Real world evidence (RWE) in the oncolgy M&A space is demonstrating that ONCY's valuation is between US$10 and US$15 Billion, as already pointed out by way of numerous cited earlier examples 

[Noteable]

As Bay Bridge Bio's author admitted .."For the sake of simplicity, I just modeled the income statement" - Now talk about Bay Bridge Bio being simple minded !!

[westcoast1000]

Thanks everyone, for the encouraging comments and information. Some company out there is going to want ONCY. And it will pay up for the opportunities we offer.

[Noteable]

And why didn't you look into Bay Bridge Bio's methodology whereby the author admits that "this model uses a simple risk-adjusted NPV model to calculate valuation." Bay Bridge Bio uses a default approach model that does not capture what is happening in the evolving global ecosystem/environment. "For the sake of simplicity, I just modeled the income

[westcoast1000]

Let us hope for peace and cooperation on this thread, and among all those waiting for ONCY. Fox is committed to the company's success just like everyone else who offers positive views on this board. No need for discord among those on the same side

[fox7mf]

Well, hopefully some BP see's Oncy's value at $15b one day soon, but that's going to be a tough sell for biotech currently trading at $2.57cad. 

[Noteable]

fox7mf = FUD poster.

[fox7mf]

I hope everyone appropriately rolled their eyes at this 'fud poster' comment. I've done nothing but support this company. Seems to me someone is a little touchy, and no matter how many times a $15b buyout is suggested, the current SP says it's not on the near term horizon. Fud poster, lol.

[Noteable]

Current share price has nothing to do with the acquisition price. Anyone who has their "eyes rolled" is not living in the "real world" of today and instead is trying to rely on old net present valuation (NPV) models that have no practical application in early - late stage "biologically based" biotech companies who are presently not generating income. Regardless of

[fox7mf]

You're right, I'm all about the FUD lol.  Now instead of reiterating the $15b price tag for Oncy over and over, why don't you put your money where your mouth is and tell us when the buyout will occur and who'll be doing the buying out. SP does matter. No biotech is receiving a 6000% premium on SP.  Wakey wakey.

[Noteable]

"Current share price has little/nothing to do with the acquisition price" - This is exemplified by the single agent pre-clinical biotech company Trillium Therapeutics being acquired by Pfizer for US$2.3 Billion at a time when CD47 blockade was just an undefined concept.

[Lesalpes29]

I suppose Not Stable strike again.! When you have enough of his repetitive posting and personnal attacks you can easily put him on ignore. It's cleaning a BB! GL Fox.

[fox7mf]

Exactly. How dare anyone question Noteable and his calls for a $15b buyout hahaha. Do I believe Oncy is worth that ? Yes. Do I believe we are currently in position to receive an offer in that neighborhood? Nope. I was actually being positive suggesting that if Bay Bridges model applied to Oncy right now, we'd be negotiating with BP with a +$2.5b market cap, not  the pittance of a mc we

[Noteable]

To reiterate -> fox7mf = FUD poster

[fox7mf]

To reiterate, Noteable, off his/her rocker. Help is available friend.

[Noteable]

fox7mf for someone who has little to nothing to offer - you sure have a lot to say.

[fox7mf]

Learn to read, write and do something other than attacking posters for adding an argument to your prognostications. Understood?

[Noteable]

To reiterate -> fox7mf = FUD poster - understood!

[fox7mf]

Sigh...Noteable, run along now. Your petulant outbursts and attacks are telltale signs of insecurity and therefore they undermine the confidence you try to exude in your posts. 

[Noteable]

Foxy - "Your petulant outbursts and attacks are telltale signs of insecurity" and further describe your repeated attempt at FUD. My posts just pour cold water on all your hot air.

[Lesalpes29]

Not Stable is probably le beau frere de Matt! GL Fox!

[Noteable]

Furthermore, as Bay Bridge Bio's author admits "this model uses a simple risk-adjusted NPV model to calculate valuation." Bay Bridge Bio uses a default approach model that does not capture what is happening in the evolving global ecosystem/environment. Bay Bridge Bio goes on to more correctly state that: "An increasingly common, but more complex, valuation technique is

[Noteable]

(Note Gilead's acquistion of single asset Immunomedics for U$21 Billion, Merck's acquistion of Phase 2 Prometheus Biosciences for US$10.8 Billion, Pfizer's US$43 Billion offer for Seagen, Amgen's US27.8 Billion acquisition for Horizon Therapeutics, Illumina's US$ 8 Billion for Grail, and a growing number of similar examples)