Earnings Labs

Oncolytics Biotech Inc. (ONCY)

Q2 2020 Earnings Call· Tue, Aug 4, 2020

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Transcript

Operator

Operator

Good day, everyone and welcome to the Oncolytics Biotech Second Quarter 2020 Earnings Conference Call. Today's conference is being recorded. [Operator Instructions] At this time, I'd like to turn the conference over to Tom Galassi of LifeSci Advisors. Please go ahead, sir.

Tom Galassi

Analyst

Thank you, Operator. Good afternoon, everyone and welcome to Oncolytics Biotech second quarter 2020 conference call. Earlier today, Oncolytics issued a press release providing their financial results and corporate updates for the second quarter of 2020. A replay of today's call will be available on the investor relations section on the Oncolytics website approximately two hours after its completion. After remarks from company management, we will open the call for Q&A. As a reminder, various remarks made during this call about the company's future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent Annual Report on Form 20-F that’s on file with the SEC. In addition, any forward-looking statements represent the company's views only as of today, and should not be relied upon as representing their views at an any subsequent date. Except as required by law, Oncolytics specifically disclaims any obligation to update or revise any forward-looking statements, even if the company's views change. Now, I will turn the call over to Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. Matt?

Matt Coffey

Analyst

Thanks, Tom. And thanks to all listening for joining us on the call today to discuss our second quarter corporate update. Now in addition to Tom, I'm joined by Andrew de Guttadauro, our Global Head of Business Development; and Kirk Look, our Chief Financial Officer. As I begin today's call, I'd like to say how incredibly proud I am of all the members of the Oncolytics team. Their talents and unwavering dedication has allowed us to make truly remarkable progress over the last quarter, particularly in light of the unpredictable and industry-wide challenges posed by the COVID-19 pandemic. Through the efficient implementation of a robust business continuity plan, Oncolytics was able to achieve five clinical milestones, including three data readouts in the second quarter. Completion of these milestones has proved important clinical validation of our unique Oncolytics virus immunotherapy platform, while also advancing our lead breast cancer program towards the initiation of a registration study. Looking forward, we are well positioned to continue recording a steady cadence of value creating milestones across our diverse clinical pipeline. Now let's move on and provide some of our highlights from our productive quarter. We remain focused on the clinical advancement of pelareorep, our intravenously delivered immuno-oncolytic virus, towards a registrational study in HR positive and HER2 negative metastatic breast cancer. A substantial unmet need exists in this indication as currently approved therapies are unable to produce a meaningful survival advantage for the over 112,000 patients with the disease in United States alone. To address this unmet need, we continue to build on the results of our Phase 2 study IND-213, a metastatic breast cancer trial that showed a near doubling of overall survival with pelareorep treatments in HR positive HER2 negative patients. Encouraged by this data, we are conducting our AWARE-1 and BRACELET…

Andrew de Guttadauro

Analyst

Thanks, Matt. As we mentioned in the past, there's a growing interest from large pharma and biotech companies, including the efficacy of Checkpoint Inhibitors by pairing them with Oncolytics Biotech, which has been marked by several deals by companies such as Merck, REOLYSIN J&J, which have typically then preceded by initial collaboration designed to evaluate the feasibility of potential combination. This is the exact approach Oncolytics taking with our ongoing pelareorep study to evaluate potential synergies versus Tecentriq, Pfizer and Merck KGaA potential CMS [indiscernible] and now in such retifanlimab. The way which we have been able to gain such central industry collaborations has been by leveraging our robust clinical datasets, and the exciting market opportunities presented by the clinical AWARE-1 study. One recent example of successful execution of the strategy is the IRENE study Mark discussed earlier. As pelareorep stability to increase tumor PD L1 level is precisely withdraw the initiation of the [indiscernible] responsive trial. This collaboration, along with our ongoing co development agreement with Pfizer, Merck KGaA in post-treatment study are just two examples of how we're constantly leveraging our compelling clinical data to initiate foster relationships with pharma and biotech. Also important to note that the commercial opportunity of using pelareorep to improve checkpoint inhibitors expands beyond just breast cancer. As a whole, the checkpoint inhibitor market is expected to reach 25 billion by 2022. Even though less than one in five patients respond to these therapies further accelerate and expand growth, checkpoint companies must look to safe and efficacious ways to further expand the potential implications. Pelareorep with extensive synergy data and the ability to be administered intravenously represents an exciting opportunity to resolve. As Matt discussed earlier, we have robust clinical data set demonstrating pelareorep potential to increase the percentage of patients responding to checkpoint inhibitors. Not surprisingly, we find that these data consistently drive exciting business development opportunities across our pipeline. For example, we're currently working with BMS on a promising study evaluating pelareorep carfilzomib combination therapy in multiple myeloma patients. Looking forward, our goal is to secure global clinical and commercialization partnership to go facilitate pelareorep improvement and maximizes commercial opportunity. We expect clinical data, particularly based on in BRACELET-1 and AWARE-1 to drive us towards this goal by ongoing discussions with potential partners across the pharma and biotech industries. With that, I'll turn the call over to Kirk Look, our CFO to discuss our financial results in the quarter. Kirk?

Kirk Look

Analyst

Thank you, Andrew and good afternoon everyone. I'm pleased to report that Oncolytics remains in a sound financial position as we advance Pelareorep towards registration. Our balance sheet continues to remain strong with cash equivalents of $29.9 million at the end of the second quarter, which includes net proceeds of $6.4 million for at-the-market facility which was recently removed, and importantly, extends our financial runway to the end of 2021. Research and development expenses for the second quarter of 2020 was $2.5 million compared to $3.4 million for the same period last year. These activities centered on progressing our AWARE and BRACELET studies, supporting our other checkpoint inhibitor combination trials, and securing our clinical supply with the start of cGMP production ramp. Operating expenses for the second quarter were $3 million compared to $1.8 million in 2019. During this period, the increase in our operating expenses related primarily to an increase in our Investor Relations and business development activities, as well as an increase in our Directors and Officers insurance premiums. Finally, our net loss in the second quarter was $6.8 million compared to $5.3 million last year, equating to a loss per share of $0.17 for the quarter versus $0.26 for the quarter in 2019. With that, I'll hand it back to Matt. Matt?

Matt Coffey

Analyst

[technical difficulty] viruses, which as, Andy have mentioned, is an area of great interest to large pharma. Almost all other Oncolytic viruses development, either have at least one and often both of these two characteristics. They require special handling procedures due to BSL 3 classification or they require intra-tumoral delivery and therefore, cannot reach metastatic disease. Notably, Pelareorep is administered systemically by nursing staff, requires no special handling procedures and has been clinically demonstrated to selectively replicate in local and metastatic tumors. These characteristics offer also the substantial competitive advantages over other oncolytic companies. Further, Pelareorep is only bio-agent to show survival benefit in late-stage metastatic breast cancer and is supported by data from multiple clinical studies demonstrating its potential to augment checkpoint inhibitor therapy. Looking ahead, we expect to build value through the sustained progression of our clinical programs and continued development of our industry partnerships. We believe we're well on our way to advancing our lead HR+/HER2- metastatic breast cancer program into a registrational study and we continue to work diligently with our academic and industry collaborators to broaden the commercial opportunities in hemological and GI malignancies. Though we expect the future of the pandemic to presents challenges across the biotech department industries, the extraordinary dedication and talent displayed by our employees and partners over the last several months makes us confident that we'll continue to build on the positive momentum generated last quarter. This will allow us to continue generating value for our shareholders and most importantly, for the lives of cancer patients. With that, I would now like open the lines and take some questions. Operator?

Operator

Operator

Thank you. [Operator Instructions] Our first question from Jonathan Aschoff with Roth Capital Partners.

Jonathan Aschoff

Analyst

Thank you very much. Because the lines a bit shattered, so I hope you can hear me, we’ve had a bit of a storm over here. But, over the past six – yes, well really over the past six months or so about moving into GI cancer and I think I heard you extremely brief in your prepared remarks, but can you better elaborate on the developments in that disease setting?

Matt Coffey

Analyst

Yeah, no. Andrew's been very busy in this regards. We are working on various protocols now. What we're contemplating and hopefully in the context of an industry partner will be a GI BRACELET study, if you will. We've seen positive results in colorectal, we just published those results. EMCI published a positive study in pancreatic cancer, and pre-selected patients to canceric expression. And so we very much believe it's an area that we should be pursuing. We do have a number of industry partners that are recording for these protocols are nearly completed. So I think it's just a question of execution and then hopefully that will be at 2020 event. Obviously, everybody's stuck working from home, so it's hard to get committee approvals. But Andrew's done a phenomenal job of moving these initiatives ahead for us. And it's something we hope to be able to announce second after year.

Jonathan Aschoff

Analyst

Okay. There's a second question. A couple of -- just kind of bear with me. But, when you see a critical mass data symptom of cancer, you know symptoms of breast cancer and I guess correct me in these numbers, its seems to be early 2017 and you better IMD 213 that was about 77 patients. And then I believe you said what we've seen from them has just a symptom has just been about a dozen or so patients and -- dozen or so families. And so, when I say critical mass, I mean, when do you have a critical mass patients in breast cancer, some line of breast cancer, I mean enough data so that you can construct a pivotal trial containing only one variable between only two ones so that you can best see the contribution from pelareorep?

Matt Coffey

Analyst

It was a great question. And it's one that comes up all the time, 77 patients and the study in terms of that small is very, very clear. Obviously people are looking for a larger end but we were -- I think there was people looking at the results and saying, well, this is fantastic, but the protocol was really written as it being a cytotoxic. And now you're seeing this, delayed clinical benefit you're seeing on proportionality, it's very clear, accurate as immunotherapy. And unfortunately 213 didn't capture that, I mean, therapy data. What we're getting from that, I think some of the most compelling data that demonstrates nearly definitively what's happening at a cellular level and it because there's paired biopsies, between the initiation of the study and the final mastectomy we can -- by looking in the tumor microenvironment and the peripheral blood, pelareorep complete story of why 213 was a success. How the immune system was engaged toward the order the engagement like was with the relative contribution of natural killer cells versus the T cells are. We unfortunately, are living in the middle of the pandemics. So the -- aware study was paused for three months. We used that time to double the number of centers. That group is very excited about the study going forward. We did have a KOL call with the investigator was talking about the future of the agents. I think AWARE-1 gives us the complete study. And right now, we just finished the safety evaluation with the DSMB. They found no concerns with it. So now we can enroll the remainder of the study. Always when you start these studies, there's a bit of a risk because we were giving a checkpoint inhibitor to women who have full functional immune…

Jonathan Aschoff

Analyst

Okay. And the former CMO, what -- why was the departure and what caused that?

Matt Coffey

Analyst

Typically, this type of disclosure, we could say someone worked there, then they didn't. We brought on Dr. Tom Heineman. He's got a background in infectious disease in oncology. He's a fantastic hire for us, and actually has been working to already integrated and perfect clinical team over the last several weeks, so I would look to him, but we really don't discuss why people leave organizations.

Jonathan Aschoff

Analyst

Okay. And the last, two part [ph] was there any ATM usage, since June 30th and what it means to either way on ATM?

Matt Coffey

Analyst

Chris, that's your bailiwick. I'll let you answer that one.

Kirk Look

Analyst

Yeah, we've used it in July so $1 million terminology ATM post renewal.

Jonathan Aschoff

Analyst

Okay. And what we named on it?

Matt Coffey

Analyst

That'll be 38 million.

Jonathan Aschoff

Analyst

Okay. Thank you very much. Operator: [Operator Instructions] We are moving next to John Newman with Canaccord. Q – John Newman: Hi, guys. Thanks for taking the question this afternoon. Question is on the BRACELET study. I'm just curious if he can talk to us specifically about what you're looking for in terms of T cell clonality? And just wondering if you could talk about, in the past, for example, when the PD-L1 inhibitors were first being developed, why people weren't able to look at that at level of detail that they are now? Thanks.

Matt Coffey

Analyst

Great question. So the T cell clonality that we talked about, really what it is it's a snapshot in time of what your T cells are doing. And T cells are a great way of demonstrating that you've had the vaccination affects. Everyone now is very focused on vaccines and what have you. These things like T cell clonality can actually guide patients like you can look for an antibody response or you can look for a T cell response. But essentially what we're looking for is -- and it's a three arm study, so with the Paclitaxel standard cytotoxin still increase T cell clonality. So our expectation is that patients will receive the Paclitaxel, we'll look at a baseline in three weeks later. We really don't anticipate there'll be much of a change in the composition of constitutional T cell response. If we see that successful vaccination effects and we draw the natural killer cells to the tumor and we get licensed, what we expect to see is the generation of brand new T cell clones. And if anyone's ever seen our plot, what happens is that baseline you don't have the T cell clones and post-treatments. What we're looking for is the generation 200, 300, 400 unique novel clones that are likely to act tumor epitope and viral epitope. And those are typically on the vertical access of our abundancy plot. And really all that's telling us is yes, this guy has now had the immune system exposed to viral epitope and tumor epitope. And they've had this very positive response. Now, checkpoint inhibitor is other than CTLA-4 which we haven't worked with clinically don't generate in T cell clones, they don't prime the immune system. So we should be able to tease out that the virus is…

Operator

Operator

[Operator Instructions] And it appears that all the time we have for questions at this time everyone. I'll turn the call back over to our speakers for any final or additional remarks.

Matt Coffey

Analyst

Thank you, operator. I appreciate that. And listen, thanks everyone for taking the time to listen to the calls. I appreciated. Our earning season is very busy. Other than that, I just wanted to thank everyone for their time and I want to say to all the staff and Oncolytics for all the hard work and all the collaboration and all the industry participation and the patients and their families to participate in the studies. Thanks very much, operator.

Operator

Operator

You are quite welcome. That does conclude our conference call for today everyone. Thank you all for your participation. You may now disconnect.