Oncolytics Biotech Inc T.ONC

ONCY Corporate Investor Presentation

[Noteable]

January 2024 ... Latest Corporate Investor Presentation

https://oncolyticsbiotech.com/wp-content/uploads/2024/01/Oncolytics.Deck_.January.pdf

March 07, 2024 - ONCY Q4 2023 & full year financial results

https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-reports-fourth-quarter-and-full-year-2023-financial-results-and-operational-highlights/

"New translational data in breast and pancreatic cancer reported in the fourth quarter continued to highlight pelareorep’s role in stimulating tumor-directed immune responses and shaping the tumor microenvironment, affirming its immunotherapeutic mechanism of action (MOA).

These [ Bracelet & Goblet] studies also point to the potential use of tumor-infiltrating lymphocytes, or TILs, as a clinical biomarker for future studies and patient care based on a positive association with tumor responses.

We are optimistic about the potential for pelareorep to provide improved outcomes for cancer patients and look forward to updating investors and our key stakeholders on our registrational readiness and progress as the year unfolds,” concluded Dr. Coffey.

** Comments on Phase 3 Breast Cancer Registrational Study

“Positive 2023 data further de-risked pelareorep and re-defined Oncolytics as a late-stage cancer company. Data from the randomized BRACELET-1 breast cancer trial in HR+/HER2- metastatic patients, reported in June using a March 3, 2023 cut-off date, nearly tripled response rates in the test arm compared to the control arm. Additionally, median progression-free survival was 50% higher in the test arm, and the hazard ratio was 0.29. In the coming months, we expect to report overall survival results from the BRACELET-1 study and define a registrational path that will focus on patients with metastatic HR+/HER2- disease and utilize a pelareorep/paclitaxel combination. Productive, ongoing discussions with our clinical collaborators and potential strategic partners have sharpened and enriched our thinking on the design of this study,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.

** Results of Goblet 1/2 Trial in first line pancreatic cohort presented at ESMO 2023:

https://oncolyticsbiotech.com/wp-content/uploads/2023/10/ESMO_2023_PDAC_poster-FINAL1a.pdf

With these results in hand, we have expanded enrollment in the anal cancer cohort, and, in pancreatic cancer, we intend to initiate an adaptive trial in first-line patients this year. This registration-enabled study will be a landmark achievement for Oncolytics and evaluate the GOBLET pancreatic cohort treatment regimen that was granted Fast Track designation by the FDA. 

** Third-line metastatic colorectal cancer patients receiving pelareorep, atezolizumab, and trifluridine/tipiracil (Cohort 3) recorded a 40% disease control rate and met the pre-specified success criteria according to the Simon two-stage methodology.

These findings are encouraging given that exhaustion of tumor-infiltrating lymphocytes, resulting from late stage of disease and extensive prior chemotherapy, may have limited their ability to expand in response to treatment. Notably, this is the second GOBLET study cohort in a row that has met its success criteria, further supporting pelareorep’s ability to synergize with atezolizumab. These data also support pelareorep’s immunologic mechanism of action and will inform our plans for further development.”

https://oncolyticsbiotech.com/press_releases/oncolytics-achieves-success-criteria-for-efficacy-in-the-third-line-colorectal-cancer-cohort-of-the-goblet-study/

https://oncolyticsbiotech.com/wp-content/uploads/2023/10/ESMO_2023_CRC-FINAL.pdf

[canadafan]

The presentation is a lot tighter & closer focus than previous. big picture? They comment a few times, a few different ways. paraphrasing.... phase 3 trial parameters, timing erc will be updsted first half of this year. being near the end of March, we are looking @ a 3 month window. There is clear indication the Pancreatic cancer collaborator will be Roche. The MBc wide open as TBD. What we

[Noteable]

Significant advantages with ONCY's pelareorep are that pelareorep is intravenously (IV) administered as opposed to intratumoral (IT) administration with other OV agents and that pelareorep is safe to use and can be manufactured at a cost efficient price point. Furthermore, according to Wang et al. writing in the Journal for Immunotherapy for Cancer, " Mechanisms for intravenous

[Noteable]

February 2024 - Immunotherapy for Cancer in India - a complete guide Unlike typical viruses that cause illness, oncolytic viruses target cancerous tissues, offering a promising treatment option.  https://www.denvaxindia.com/blog/immunotherapy-for-cancer-in-india-a-complete-guide/

[Noteable]

Patients in the Phase 2 Goblet-1 PDAC cohort, presented at ESMO 2023, are undergoing first-line treatment with a combination of pelareorep, atezolizumab, gemcitabine and nab-paclitaxel. The 13 evaluable patients enrolled in the first stage of the study have been evaluated based on a September 18, 2023 data cut-off date. The enrolled patient population included 93% of patients with

[ENEMENEMYNEMO]

Hey B  O   T, thanks for the rehashing of all the old news quite useless , algorithm needs tweaking.  You got anything new to share??

[Azzak34]

Your grammar needs tweaking. There's no hurry to post, just re-read what you've wrote and fix the numerous errors. The extra few seconds are worth it I promise. 

[Noteable]

Well, if I seem to be"reshashing" your wild conspiracy "bot" allegations, then so be it.

[Peladawn]

This post has been removed in accordance with Community Policy

[Noteable]

As pertinent as March 07, 2024 and beginning with the January 2024 Investor Presentation .... January 2024 ... Latest Corporate Investor Presentation https://oncolyticsbiotech.com/wp-content/uploads/2024/01/Oncolytics.Deck_.January.pdf March 07, 2024 - ONCY Q4 2023 & full year financial results https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-reports-fourth-quarter-and-full

[Noteable]

In ONCY's Q4 2023 Earnings Conference call Allison Hagerman outlined that:  In the fourth quarter of 2023, ONCY initiated a new GMP production campaign with the drug substance process transitioned to single use equipment and scaled up to a 200 liter bioreactor. Now larger bioreactors can be employed when FDA approval is granted. The first GMP batch was completed this last quarter and

[Quentin30]

NO NO NO... ONCY is NOT yet regsitered, so whenever the BLA is submitted, whatever manufacturing process is in place is the one they will register. You're trying to mislead people here into thinking this is something of significance. ONCY has no news, this was a bg fat nothing burger... just like you.

[ENEMENEMYNEMO]

Thank you!

[Noteable]

The FDA is involved and notified whenever major changes have been implemented including the manufacturing changes outlined in my previous post and  that have been highlighted in bold font. In ONCY's Q4 2023 Earnings Conference call Allison Hagerman outlined that:  In the fourth quarter of 2023, ONCY initiated a new GMP production campaign with the drug substance process transitioned