A Pure Market Play With One Of The Most Undervalued NASDAQ Stocks We’ve Seen In a While – STRONG BUY

Multi-Billion-Dollar Pharma Giants Have Teamed Up with Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC) – Ahead of STRONG BUY Catalyst Event to Where Analysts Projected Them in 2022!


EDITOR’S NOTE* With Wall Street analyst coverage giving ONCY a price target of $15.00, these rock bottom prices you are currently seeing probably won’t last long – We are looking at a potential increase of over 970% from current levels, with what we believe could be the perfect catalyst event on the horizon, so get positioned, and get positioned now! Take a look here: https://www.nasdaq.com/market-activity/stocks/oncy/analyst-research


It’s rough out there! Stocks are getting beaten up, and some analysts are projecting that Biotech stocks in particular have a grim near-term outlook![1] However, that outlook is NOT universal, as there are others that are projecting that valuations may have finally bottomed and are now leaning towards a more cautiously positive outlook.[2]

So… what does the smart investor look for amid such uncertain volatility? What they’re looking for are CATALYSTS!

In the biotech world, those catalysts often come when the FDA gives either a FAST TRACK or BREAKTHROUGH designation for an asset.

Just look at some of the stocks that recently had their big announcements come through, and what happened to them each within the first 5 days of trading after their announcements…

Share Prices and Market Cap Values taken on August 23, 2022 from Yahoo! Finance

THIS play that we’ve identified has MORE potential than any other Biotech stock we’ve seen, and the timing is near perfect for an entry as it’s been beaten up, dropped to what we believe is a bottom, and has now stabilized. That means now it’s ready to go UP, and all it needs is that big, BIG catalyst.

That company is Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), a cutting-edge development-stage biopharmaceutical company, with a lead product called pelareorep designed to treat solid tumors and hematological malignancies, and several co-development agreements in place, including with Merck KGaA and Pfizer Inc., that’s positioned to become a game changer in the cancer space.

We believe we’ve identified Oncolytics’ catalyst ahead of time (coming in the next 6-8 months), and this one’s likely going to be HUGE!!!

Ahead of these types of catalysts, however, there are SIGNS to look for, and we believe that Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) has more than shown enough to keep our interest as their news flow presses onward.

RIGHT NOW they’re already capturing the attention of the entire sector, with their latest round of results hinting towards what could potential lead to a coveted FDA designation, which likely would truly get the party started.

As you’ll soon see, we’re not the only ones recognizing ONCY’s epic potential at this stage.

EXPERTS are giving Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) a STRONG BUY rating, as per NASDAQ.com’s consensus of Analyst ratings.

What could these analysts be seeing that the rest of the market is not? Well, we can’t speak for them, but we can tell you what we’re seeing, and why ONCY is one of the best gems we’ve come across in years.

YOU TOO can look hard enough at the small amounts of data that’s already available, and see what we see… ONCY is an absolute STEAL in the making!

Look, these Analysts have clearly given ONCY price targets averaging $15!

That’s a growth projection of nearly 10x its current price of $1.40 per share!
An increase of over +970%!


7 Reasons Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC)is an Oncology Game Changer

 Standing with GIANTS: 
The huge potential of pelareorep has drawn the attention of some big league players in the industry, including a partnership with Adlai Nortye, co-development with Pfizer and Merck KGaA, as well as collaborations with SOLTI and Roche, as well as combinations in development with Merck Serono, Bristol-Myers Squibb, and Incyte.

 Pelareorep is a SUPERSTAR:
This immunotherapeutic agent generates an anti-tumor immune response, by training anti-cancer cells, while reversing immunosuppressive TMEs.

3  Near DOUBLING of Overall Survival:
Randomized Phase 2 data has already shown a statistically significant near doubling of OS in HR+/HER2- breast cancer, while de-risk trials in gastrointestinal and hematological cancers is also showing strong promise.

4  Synergy with Immune Checkpoint Inhibitors: 
The ICI market is expected to exceed $55B by 2025, despite as few as 1 in 5 patients responding to ICI therapy. Pelareorep has clinically demonstrated its ability to synergize with these ICIs, perhaps enhancing their effectiveness.

5  Big DATA Months Ahead: 
Not only is there an upcoming catalyst expected in 2022 from its Phase 2 pelareorep-ICI combo trial in HR+/HER2- breast cancer to facilitate the asset’s advancement to a registrational study, but also data from its GOBLET study appears to have already met the success criteria for efficacy in State 1 of its pancreatic cancer cohort, with a strong efficacy signal so far that has easily exceeded expectations.

6  Strong Leadership Team: 
Proven Management Team and Board of Directors that combines over 150 years of experience in drug development and the biopharmaceutical industry, including a World Congress Pharma Executive of the Year award winner Chair of the Board.

7  Complimentary CAR-T Program:
The company is adding combination therapy with CAR-T cells to their lineup, in what they believe to be a perfect one-two punch combo in the battle against cancer.



BREAST AND PANC: TWO LEGIT PATHS TO APPROVAL

Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) has been clear in its objectives to target important segments, beginning with Breast Cancer, which is projected to reach US$55.27 billion by 2027, growing at a CAGR of 13.1% along the way.[8]

But don’t discount the potential for pelareorep’s approval to treat pancreatic cancer BEFORE it gets to that stage with breast cancer.

Why?

Because pancreatic cancer is a much deadlier cancer with a much faster progression.

With a 92% mortality rate, pancreatic cancer is a nearly automatic death sentence.[9] Once pancreatic cancer has spread to other organs, surrounding lymph nodes, or other parts of the body, the average life expectancy is just 3-6 months.[10]

In comparison, breast cancer diagnoses carry with them an average 90% 5-year survival rate across all SEER stages.[11]

This means that it’s theoretically much easier to quantify efficacy and an improvement of survival in pancreatic cancer, as data collection is in a much, much smaller window.

For every month a patient outlives the average life expectancy in the pancreatic cancer cohort, the more quantifiable the potential impact a therapy’s use can be.

Which brings us to the CURRENT state of ONCY’s GOBLET study.

NOW FOR THE NEXT BIG CATALYST IN THE MAKING

In late June, 2022,  Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) announced it had achieved success criteria for efficacy in the study’s pancreatic cancer cohort.[12]

Within the presentation that was shared at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2022[13], with a corresponding poster presentation, that can be found by clicking here.

As per a late 2021 press release on the study, we see that the pancreatic cancer cohort in the study has a total of 12 patients enrolled.[14]

So what have we seen so far?

In the pancreatic cancer cohort, it can’t be ignored that the data “show a strong efficacy signal as evidenced by all patients achieving a partial response.” – [Note: Emphasis ours]

Did you catch that? ALL PATIENTS achieved a response.

That’s 3 for 3 on the first patients we have data for.

“With Stage 1’s pre-specified efficacy threshold met after just the first three patients, the GOBLET trial’s pancreatic cancer cohort is clearly exceeding expectations.” – Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial

Moving forward Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) is obviously going to follow this cohort closely to see if these initial positive results are substantiated as the remaining 12 patients in the cohort are evaluated and the data matures.

Because we know how small the window for pancreatic cancer patients typically is on average, that means we’re set to gain this data in the very near-term future.

Now… we know what you’re probably thinking. It’s just 3 patients so far.

Well, it all depends on how you look at the current benchmarks for success in this sector.

And for that we can look no further than the 2013 reference in the New England Journal of Medicine by Dr. Von Hoff, titled Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine.[15]

Why this study?

Because it’s a pre-cursor to what we’re looking at now, and what ONCY is attempting to build upon with pelareorep.

As you can see by the chart below, the cohort we’re discussing in the GOBLET study is Cohort 1.

Cohort 1 is studying the effect of Pelareorep + Atezolizumab + Gemcitabine with Nab-Paclitaxel. That last portion (Gemcitabine/Nab-Paclitaxel) is what the 2013 study originally looked at.

How were the results of that study in 2013?

  • The median overall survival (OS) was 8.5 months for the combo vs 6.7 months for gemcitabine alone
  • The survival rate was 35% in the combo group vs 22% in the gemcitabine group alone at 1 year
    • 9% vs 4% at 2 years
  • The median progression-free survival (PFS) was 5.5 months in the combo vs 3.7 months in the gemcitabine only group.
  • The response rate was 23% vs 7%

Those results were good enough to see the FDA approve nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer in September of 2013.[16]

To recap, before it was approved, nab-paclitaxel:

  • Increased mean overall survival (OS) duration by 26.8%
  • Increased median progression free survival (PFS) duration by 48.6%
  • Increased 1-year survival rate by 59%
  • Increased 2-year survival rate by 125%
  • Increased response rate by 228.5%

Now go back to our GOBLET study results so far, and we’ve got positive results from 3 out of 3 of our cohort of 12.

This cohort was enrolled in November 2021, more than 7 months prior to us getting these latest results in late June 2022.

So that’s 100% of the first three patients, and nearly statistically impossible for the remaining NINE to drop off. That means, we’re looking at what appears to be an incredible game changer.

Given the relatively short window of survival for those unfortunately diagnosed with pancreatic cancer, it’s legitimate to project that the market should be expecting updated data from GOBLET in the second half of 2022, likely containing what we want to know about those last nine.

But for now, this 3 for 3 result is telling us to buckle up… because the rocket countdown has begun.


A CLOSER LOOK AT PELAREOREP

Pelareorep can potentially be combined with a number of checkpoint inhibitors, which are a class of compounds that block the proteins that keep the body’s immune system from naturally seeing a tumour.

When combined with these compounds, pelareorep can cause more inflammation in the cancer cells, which, as noted above, alerts the body’s immune system to the presence of those cells and allows it to fight off tumours faster and more effectively.

Pelareorep has also been combined with more traditional chemotherapies and has been shown to increase the overall survival of women with hormone-receptor positive, metastatic breast cancer who are treated with paclitaxel. This is a promising improvement for patients.

Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) is focusing on combining pelareorep with a range of the biggest names in the immunotherapy sector across multiple cancer indications —including in studies with Bavencio®, Keytruda®, Opdivo® and Tecentriq®.

Oncolytics’ primary objective is to obtain regulatory approval for pelareorep as quickly as possible.

FRIENDS IN HIGH PLACES

Oncolytics has established a successful partnership with Adlai Nortye in China, Hong Kong, Macau, Singapore, South Korea and Taiwan. As per the relationship, there is an upfront and milestone payments of up to $86.6 million, with $65 million tied to potential development expansion.

Perhaps most notable are the 5 ongoing studies Oncolytics is performing with PfizerMerck KGaAMerckBristol-Myers Squibb, Incyte, and Roche. These involve checkpoint inhibitors, targeting metastatic breast cancer, early-stage breast cancer, multiple myeloma and pancreatic cancer.

BONUS CAR-T PROGRAM

When Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) sought out the perfect combination for its flagship pelareorep’s immunotherapy capabilities, it became more and more obvious that the company was destined to enter the CAR-T therapy field, which has been dubbed a breakthrough treatment for patients with certain types of blood cancers, such as lymphoma and leukemia.

In 2020, treatment using CAR T-Cells led to complete remissions in 70% of patients[17] with anti-CD19-resistant acute B-cell leukemia—up from a much lower 7% with other treatments.

It’s the perfect complement.

Pelareorep is a naturally derived, non-genetically engineered oncolytic virus that can be delivered intravenously and that preferentially infects cancer cells. This means that pelareorep attacks and kills cancer cells while leaving healthy cells intact. As the virus kills cancer cells, it alerts the body to the presence of these cells and activates the immune system against the tumor. Despite being a virus, pelareorep is not known to cause any disease has been shown to be safe in over one thousand patients.

CAR T cells, meanwhile, are created by drawing blood from a patient’s own body, separating the T-cells (which help produce an immune response and kill infected cells ), and genetically engineering them to produce receptors (chimeric antigen receptors, or CARs) on their surfaces.

It is thought that pelareorep will enhance the effect of CAR T-cell therapy because the virus alerts the immune system to the presence of cancer cells, which can be good at hiding from the immune system. Treating them with pelareorep exposes them, and signals CAR T-cells to mount an assault on the cancer.

For an extremely in-depth overview on what CAR T is and how it works, please watch this video located here: https://www.youtube.com/watch?v=gmjLSeAXAmw

THE BRAINTRUST BEHIND ONCOLYTICS BIOTECH

In order to take a proprietary biotech asset such as pelareorep through the trials along the road to approval, the entire process requires good stewardship. Thankfully, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) is in VERY capable hands, built upon experience among management and directors with several leaders in the sector such as Amgen, Bristol-Myers Squibb, GSK, Sanofi Pasteur, National Cancer Institute-Frederick Cancer Research and Development Center, Harvard Medical School, and Princeton University.

ONCY’s leadership team includes:

Co-Founder, Director, President & CEO – Matt Coffey, PhD, MBA

Dr. Coffey completed his doctorate degree in oncology at the University of Calgary with a focus on the oncolytic capabilities of the reovirus. The results from his research have been published in various respected scientific journals, including Science, Human Gene Therapy, and The EMBO Journal.

Head of Clinical Development and Operations – Thomas Heineman, MD, PhD

Dr. Heineman completed his medical degree and doctorate in Virology at the University of Chicago. His drug development experience spans more than 25 years including 15 years in the biopharmaceutical industry. He has held senior roles at GSK, were he led the clinical development of Shingrix, and at several biotechnology companies where his focus has been oncology and immuno-oncology. Dr. Heineman has led clinical programs in multiple oncology indications including breast cancer, pancreatic cancer, B-cell lymphoma, glioblastoma and colorectal cancer.

Global Head of Business Development – Andrew de Guttadauro

de Guttadauro is +25-year biopharmaceutical commercialization and business development veteran, who’s held executive and senior-level positions at leading pharmaceutical and biotechnology companies, including as VP of Corporate Development at Vical supporting the execution of distribution agreements for Allovectin®, and a variety of positions at Amgen where he contributed to the success of Enbrel®, Aranesp®, and Epogen® before joining MedImmune to lead marketing efforts for the FluMist® inhaled influenza vaccine. He also served as Director of Strategy at Biogen Idec.

Chair of the Board – Wayne Pisano, MBA

Pisano was recognized as Pharma Executive of the Year by the World Vaccine Congress in 2010. He served as the President and CEO of VaxInnate, and has been a Board Member of Immunovaccine since 2011. He is the former president and CEO of Sanofi Pasteur, one of the largest vaccine companies in the world. He’s credited with driving SanofiPasteur’s leadership within the worldwide influenza market and capturing 50% of global sales.

The remaining leadership roles, Board of Directors, and Scientific Advisory Board consist of highly qualified members, with senior level experience with such companies and institutions as: Ernst & Young LLP, Nabisco, Hospital for Sick Children, Aptose Biosciences, Achillion Pharmaceuticals, National Cancer Institute-Frederick Cancer Research and Development Center, GPC Biotech, Harvard Medical School, Princeton University,  Massachusetts General Hospital, EMD Serono, Breast International Group (BIG), SOLTI – Breast Cancer Research Group, Amgen & BMS IO Network and more.

Director – Deborah M. Brown, B.Sc., M.B.A.

Brown is currently a Managing Partner at Accelera Canada, a specialty consultancy firm that assists emerging biopharma ventures in the United States and Europe with the development and implementation of Canadian market strategies. She held progressively senior roles at EMD Serono from 2000 to 2014, including Executive Vice President of Neuroimmunology for the company’s U.S. operations, and President and Managing Director of the company’s Canadian operations. In 2012, Brown was Chair of the National Pharmaceutical Organization (now Innovative Medicines Canada) and served on its Board of Directors from 2007 to 2014. She currently sits on the Boards of Life Sciences Ontario, the Strategic Executive Advisory Council for Canadian Cancer Trials Group, and her local SPCA.

Director – Bernd R. Seizinger, MD, PhD

Dr. Seizinger currently serves as chairman/board member in a number of public and private biotech companies in the U.S., Europe and Canada, including: Vaccibody, Oxford BioTherapeutics, Aprea, CryptoMedix, and BioInvent. Previously he was President & CEO of public oncology company GPC Biotech; VP Oncology Drug Discovery and – in parallel – VP Corporate and Academic Alliances at Bristol-Myers Squibb; and Executive VP and CSO, Genome Therapeutics. Prior to his corporate appointments, he held Senior Faculty positions at Harvard Medical School, Massachusetts General Hospital and Princeton University.


RECAP: 7 IMPORTANT POINTS TO REMEMBER FOR ONCOLYTICS BIOTECH INC. (NASDAQ:ONCY) (TSX:ONC)

  1. SIGNIFICANT PARTNERSHIPS

  2. PELAREOREP

  3. NEARLY DOUBLING OVERALL SURVIVAL

  4. SYNERGY WITH CHECKPOINT INHIBITORS

  5. IMPORTANT DATA INCOMING

  6. STRONG LEADERSHIP

  7. CAR-T PROGRAM


Now that you’ve read this far, the case has been made strong enough for you to get into action.

With what we believe are catalysts events coming in the very near future, and with the data we’ve already seen, we believe THIS IS THE PERFECT TIME for smart investors to seriously follow the ongoing ONCOLYTICS BIOTECH INC. (NASDAQ:ONCY) (TSX:ONC) story.

So, do your own due diligence, and don’t forget to click here to sign up for email alerts to make sure you don’t miss out on any of ONCY’s news and milestones.

USA News Group
Editorial Staff


DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. (“MIQ”). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.

While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.


SOURCES CITED:

[1] https://www.barrons.com/articles/biotech-stocks-outlook-gloomy-51651500943

[2] https://www.geekwire.com/2022/biotech-stocks-are-getting-crushed-but-industry-insiders-say-theres-reason-for-optimism/

[3] https://ir.aurabiosciences.com/news-releases/news-release-details/aura-biosciences-receives-fda-fast-track-designation-belzupacap

[4] https://www.globenewswire.com/news-release/2022/06/22/2466996/0/en/Ikena-Oncology-Receives-FDA-Fast-Track-Designation-for-Novel-TEAD-Inhibitor-IK-930-to-Treat-Unresectable-NF2-Deficient-Mesothelioma.html

[5] https://www.globenewswire.com/en/news-release/2022/08/01/2489266/0/en/ALX-Oncology-s-Evorpacept-Receives-Fast-Track-Designation-from-FDA-as-First-Line-Treatment-for-Head-and-Neck-Squamous-Cell-Carcinoma.html

[6] https://finance.yahoo.com/news/turning-point-therapeutics-granted-breakthrough-123000028.html

[7] https://finance.yahoo.com/news/timber-pharmaceuticals-receives-fda-breakthrough-120000350.html

[8] https://www.fortunebusinessinsights.com/industry-reports/breast-cancer-therapeutics-market-100163

[9] https://pancreaticcancercanada.ca/

[10] https://pancreatic.org/pancreatic-cancer/pancreatic-cancer-facts/

[11] https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-survival-rates.html

[12] https://ir.oncolyticsbiotech.com/press-releases/detail/578/oncolytics-biotech-achieves-success-criteria-for-efficacy

[13] https://ir.oncolyticsbiotech.com/press-releases/detail/578/oncolytics-biotech-achieves-success-criteria-for-efficacy

[14] https://www.prnewswire.com/news-releases/oncolytics-biotech-doses-first-patient-in-phase-12-goblet-study-evaluating-pelareorep-anti-pd-l1-combination-therapies-in-gastrointestinal-cancers-301415176.html

[15] https://www.nejm.org/doi/full/10.1056/nejmoa1304369

[16] https://www.cancer.gov/types/pancreatic/research/nab-paclitaxel-gemcitabine#:~:text=In%20September%202013%2C%20the%20U.S.,results%20of%20the%20MPACT%20trial.

[17] https://ascopubs.org/doi/full/10.1200/JCO.19.03279