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Oncolytics Biotech Inc. (ONCY)

Q2 2022 Earnings Call· Thu, Aug 11, 2022

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Transcript

Operator

Operator

Good afternoon, and welcome to Oncolytics Biotech’s Second Quarter 2022 Conference Call. All participants are now in listen-only mode. There will be a question-and-answer session at the end of this call. Please be advised that this call is being recorded at the Company’s request. I would now like to turn the conference call over to Jon Patton, Director of Investor Relations and Communications. Please go ahead.

Jon Patton

Management

Thank you, operator, and good morning everyone. Earlier this morning, Oncolytics issued a press release providing recent operational highlights and financial results for the second quarter of 2022. A replay of today’s call will be available on the Events and Presentations section of the Oncolytics website approximately two-hours after its completion. After remarks from Company management will open the call for Q&A. As a reminder, various remarks made during this call contain certain Forward-Looking Statements relating to our business prospects and the development and commercialization of pelareorep, including statements regarding the Company’s focus, strategy and objectives, Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic, design, aims and anticipated benefits of our current and pending clinical trials and anticipated timing of the release of the additional data. Company’s plans and expectations regarding a potential registrational study, Company’s business development plans and strategies and other statements related to anticipated developments in the company’s business. These statements are based on management’s current expectations and beliefs and are subject to a number of factors, which involve known and unknown risks, delays, uncertainties and other factors not under the Company’s control that may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these Forward-Looking Statements. In any Forward-Looking Statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions by regulatory agencies and those other factors detailed in the Company’s filings with SEDAR and the SEC. Oncolytics does not undertake any obligation to update these Forward-Looking Statements, except as required by applicable laws. I will now pass the call over off to Oncolytics, President and Chief Executive Officer, Dr. Matt Coffey. Please go ahead Matt.

Matthew Coffey

Management

Thanks, John. And good morning to all listening. As usual. Joining me on today’s earnings call are a few fellow members of the Oncolytics leadership team including Dr. Thomas Heineman. Our Chief Medical Officer; Andrew de Guttadauro, our Global Head of Business Development; and Kirk Look, our Chief Financial Officer. I would like to begin today’s call with a brief recap of our very strong second quarter, highlighting two clinical data readouts in our breast and pancreatic cancer programs that we find very encouraging. Each of these readouts further clarifies telomere reps core value proposition, which is its ability to solve one of oncology’s most prevalent and long standing problems, the inability of the immune system to recognize and infiltrate tumors. This problem extends across many tumor types and is known to severely blunt the impact of many of the most widely used and commercially successful classes. To-date the problem posed by the inaccessibility of tumors to immune cells has yet to be broadly solved, due in large part due to the multiple biological mechanisms perpetuating it. With pelareorep, or pela, as I will call it, we believe we have a safe and versatile immunotherapeutic agents that can simultaneously address many of these various mechanisms and make tumors more amenable to successful treatment with complimentary anti-cancer therapies. By doing this, we believe we could substantially broaden the commercial opportunities therapies by expanding their reach in large indications, such as HR positive HER2 negative metastatic breast cancer and pancreatic cancer, which affect approximately 114,000 and 62,000 patients yearly in the U.S. respectively. This belief is supported by data from multiple clinical studies such as IND-213, which showed a statistically significant near doubling of overall survival and HR positive HER2 negative breast cancer patients when pela was added on top of chemotherapy.…

Thomas Heineman

Management

Thanks, Matt. The most recent results from the AWARE-1 study further strengthen the overall dataset that demonstrate pela’s immunologic mechanism of action. Importantly, in doing so, these results clearly reinforce pela’s potential as a versatile platform therapy that can overcome some of the most prevalent tumor defense mechanisms. These data, which were presented at the ESMO Breast Cancer Meeting in May focused on how pela when added to the standard of care therapy Letrozole with or without the checkpoint inhibitor atezolizumab modified the tumor micro environment in HR positive, HER2 negative breast cancer patients. This is the same breast cancer subtype for which pela provided a statistically significant and clinically meaningful survival benefit in the IND-213 study, as mentioned earlier by Matt, and is the breast cancer type, we intend to evaluate in a future registrational trial. Some of the most interesting data presented at the ESMO Breast Cancer Meeting came from the PAM50 gene panel analysis that correlated changes in the tumor with the likelihood of a patient’s cancer recurring following successful treatment. These correlations were captured using a risk of recurrence score, with results showing all valuable patients, having a risk of recurrence score classified as low following treatment. This represented a near doubling from the 55% that have this favorable classification at the start of the study. These exciting results together with the previously reported AWARE-1 data including increases in the prognostic cell till score, clearly support the profound clinical benefits we believe pela can provide. They also offer a thorough understanding of exactly how pela may drive clinical benefit. In essence, pela has a multi-pronged mechanism of action by which it educates the immune system in its fight against cancer that reverses the suppressive micro environments that typically exclude immune cells from tumors and lessen their…

Andrew de Guttadauro

Management

Thank you, Tom, and good morning to all participants. I’m especially excited about today’s BD update, as we have been making meaningful progress across our licensing drivers, starting with our most important opportunity breast cancer, but also our exciting emerging opportunity pancreatic cancer and our CAR T out licensing activities. I will begin by providing context as to the potential to pancreatic data from a licensing perspective. We believe - initial data in pancreatic cancer significant from both a clinical and a business development perspective, as pancreatic cancer is one of the major PD-L1 unrealized opportunities. Despite repeated attempts, checkpoint inhibitors have failed to successfully treat pancreatic patients with the exception of the 1% of such patients who are MSI high. Given that the current standard of care can only extend survival by few months and only the minority of patients who respond pelareorep may represent PD-L1 agents best opportunity to redefine the pancreatic standard of care. Pancreatic cancer also serves as an excellent example of one of pelareorep’s core value drivers, which is its potential to dramatically expand [P801’s] (Ph) addressable patient population beyond those that are already approved. as demonstrated by AWARE-1 successfully meeting its endpoint in the pela test centric combination cohort as well as GOBLET’s current pancreatic readout. Pela has the ability to synergize with PD-L1 therapies across multiple tumor types. Pela’s synergistic potential therefore can help produce meaningful clinical responses in patients and significant need of novel transformative Clinical Solutions. Pelareorep is essential to make previously untreatable tumors amenable to successful treatment with approved PD-L1 agents positions it to create significant new opportunities across a wide breadth of indications. This potential has served as a driver for our collaborations with biopharma industry leaders, including Pfizer, Merck Serrano, Roche, BMS, Incyte and Adlai Nortye. Looking forward,…

Kirk Look

Management

Thanks, Andrew. Oncolytics continues to maintain a strong balance sheet throughout the second quarter ending June 30, 2022 with 33.7 million in cash and cash equivalence. This compares to 41.3 million in cash and cash equivalent as of December 31, 2021. I’m pleased to say that our current cash position leaves us well positioned to execute on key clinical milestones: based on our projections, our financial runway extends well into the second half of 2023, which is expected to take us through BRACELET-1’s clinical and translational data announcement, as well as the additional efficacy data from our GOBLET study planned for later this year. Turning now to our financial results. Operating expenses for the second quarter of 2022 were $2.8 million compared to $3.5 million in the second quarter of 2021. This change has been mainly due to lower investor relations activities as the current global economic and political conditions have impacted the market sentiment in the biotech industry, along with the overall capital markets. Consequently, this year, we have been mindful of our resource allocation to IR related activities. Research and development expenses for the second quarter of 2022 were $3.2 million, which remain consistent with the same period last year. Now the net loss for the second quarter of 2022 was $5.1 million compared to $7.2 million for the second quarter of 2021. This equates to a net loss of $0.09 per share for the second quarter and $0.13 per share for the second quarter of 2021. With that, I will now pass the call back to Matt for some concluding remarks. Matt.

Matthew Coffey

Management

Thanks, Eric. Before I get into concluding remarks, I would like to briefly recognize another important corporate achievement in Q2, which was the addition of James Parson to our Board of Directors. James financial and strategic acumen will be invaluable assets as we work to achieve our objectives, and we are thrilled to have the chance to draw on his 20-years of life science leadership experience. This includes over 10-years spent as the CFO of the immuno-oncology company Trillion Therapeutics, a role James held through Trillion’s acquisition by Pfizer for an aggregate purchase praise of approximately 2.1 billion. It has been a pleasure benefiting from James’s guidance in the short time, since his appointments. And we look forward to our continued work to advance pela and bring Oncolytics to its next stage of development. As we move towards these goals, we are doing so with meaningful foundation that we believe leaves us well positioned to solve the pressing problems posed by the inability of the immune system to recognize and infiltrate tumors. There are several key components to this foundation, the first be in our clinical data, thanks to the success of AWARE-1, IND-213 and other studies. We have shown that pela can train immune cells to recognize and attack tumors, modify tumor micro environments in a way that enable immune cell infiltration and derive a robust and statistically significant survival benefits in a well controlled randomized study. These are tasks that are not easily accomplished. The first two requiring a multi-pronged mechanism of action that can simultaneously modulate many biological pathways. This helps explain why the inaccessibility of tumors to the immune system remains such a prevalent problem that continues to severely hamper, a wide range of therapeutics, such as checkpoint inhibitors and CAR T therapies. With pela, we…

Operator

Operator

Thank you. [Operator Instructions] We will take our first question from Patrick Trucchio from HC Wainwright. Please go sir.

Jason Kolber

Analyst

Hi. This is Jason on for Patrick, and congrats on the progress and it is really exciting to see the BRACELET-1 study progressing. So just a quick question, because we were just wondering with the safety results presented already in 4Q 2021 for IRENE study, when can we expect additional updates on this IRENE program and what else was Oncolytics or an insight need to do to progress further into a Phase 3 trial for IRENE? And I have a follow-up question after that. Thank you.

Matthew Coffey

Management

Sure. Andy or Tom, do you want to fill that question since it is the relationship of insight?

Andrew de Guttadauro

Management

I think it is actually more Tom’s question really, because there is some rules as to how many responses would be needed in order to move forward with the expansion of the trial.

Thomas Heineman

Management

Yes. Tom here. The IRENE study continues to enroll. We have two sites open and enrolling in IRENE. And this is an investigator sponsored study as you are aware, we are in contact with the investigator regarding the progress of that study. I don’t have any updates at the immediate time regarding that. But we do hope that that study - that we will be able to update that study in the not too distant future. Although it is as investigator sponsored study. It is not fully in our control.

Jason Kolber

Analyst

Okay, yes that is helpful. And I guess the other thing we will just wondering was around the multiple myeloma studies. So when can we also expect kind of additional updates on the NCI-9603 study, which you already showed - achieved safety results in the second quarter 2020? And how about the WINSHIP 4398 trial? Thank you.

Matthew Coffey

Management

I can grab that one. Dr. Kelley actually and actually Dr. Hoffman have actually shared with us manuscripts for both studies. They are in the review process now with quite frankly quite prestigious journals. So we are hoping that both of those get accepted. We are also working with one of the investigators on a follow-on study. That would be in conjunction with a major immunotherapeutic agent. We haven’t announced that yet, but I think that will be announced, I’m hoping by the end of the year.

Jason Kolber

Analyst

Okay. Great. Thank you.

Operator

Operator

[Operator Instructions] It appears there are no further question at this time. Speaker, I would like to turn the conference back to you for any closing remark.

Matthew Coffey

Management

I would just like to say thank you all for joining us this morning to hear about a recent progress, we are obviously very excited about it. We are in the midst of an exciting time and look forward to providing additional updates and clinical advances. We do appreciate everyone’s continued interests and we do wish everyone a wonderful day. Thank you very much.

Operator

Operator

This concludes today’s call. Thank you for your participation. You may now disconnect.