Q3 2020 Oncolytics Biotech Inc Earnings Call
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Good afternoon, Walter <unk> third.
Third quarter 2020 conference call all participants <unk> only mode. There will be a question and answer session at the end of this call.
Be advised this call is pretty much all of them.
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I would now like turn the call over to John.
Director of Investor Relations and Communications. Please go ahead.
Thank you Jason Good afternoon, everyone and welcome to Oncolytics Biotechs third quarter 2020 conference call.
Year to date Oncolytics issued a press release, providing financial results and corporate update for the third quarter of 2020.
A replay of today's call will be available on the investors and media section of the on critics website approximately two hours after its completion after.
After remarks from company management, we will open the call for Q1 <unk> as a reminder, various remarks made during this call contains certain forward looking statements relating to the company's business prospects.
<unk> development and commercialization of telomere rats, including statements regarding the company's focus strategy and objectives. The companys beliefs as to the potential mode and action to pillory Europe as a cancer therapeutic design teams and anticipated benefits of the company's current or pending clinical trials and.
Their 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 expectations implied by these forward looking statements in any forward looking statement in which all critics expresses an expectation or belief as to future results such expectations or beliefs are expressed in good faith and are believed to have reasonable basis, but there can be newish.
Or is that the statement your expectation or belief will be achieved. These factors include the 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. The C. Dollar yes, he see oncolytics does not undertake.
Take an obligation to update these forward looking statements, except as required by applicable.
Now I will turn the call over to dock in their coffee, President and Chief Executive Officer upon clinics biotech Matt.
Thanks, John and thanks to all for joining us on the call today to discuss our third quarter corporate update.
In addition to John I'm joined by.
Sure.
Our global head of business developments and Mr., Chris Clark, our Chief Financial Officer.
As I begin today's call I would like to stress yet again, how thoroughly impressed ive been by the talent and the unwavering commitment of Oncolytics employees their partners and investigators as they continue to operate a mining industry wide challenges posed by the.
19 pandemic.
Through the continued execution of our business continuity plan, we've built on the positive momentum generated earlier this year to achieve three clinical milestones since our last update.
These milestones have further validated our unique oncolytic immunotherapy platform.
They have started lead breast cancer.
Oh program towards the initiation of a registration study and offered an opportunity to expand Calabria reps central market into additional indications with high unmet needs.
We believe we are well positioned to continue reporting a steady cadence of value, creating milestones across our broad clinical pipeline.
I'd like to move on and discuss.
Some of our recent highlights our primary focus is the basket of Palo <unk> or intravenously delivered you know like virus towards a registration study.
One receptor positive her two metastatic breast cancer we.
We believe coloratura can address critical unmet need in this indication as many currently available therapies are simply unable to produce.
I mean, it's a survival advantage for a significant percentage of patients.
Our belief is supported by the promising results of our phase two study R&D to 13, which showed a near doubling of overall survival with calibre of treatment in HR positive hertwo negative metastatic breast cancer patients.
We continue to build on these results with our ongoing aware.
Airwatch bracelet, one clinical trials, the completion of which will determine the design of our phase three registration program.
Now.
As a reminder.
These studies together aim to achieve three objectives to facilitate the initiation of the phase three registrational trial.
First.
He is confirmed.
EPS immunotherapeutic mechanism of action to support the promising efficacy data thats already been generated.
Second gain to validate the clinical utility of our novel blood based biomarker measuring T cell commonality to predict patient responses to Columbia Rep.
And finally, they will evaluate.
Hello, <unk> reps ability to enhance the efficacy of checkpoint inhibitors to improve patient outcomes as there is robust and growing preclinical and clinical data sets.
Turning the synergistic potential Hello, Ray Rep checkpoint inhibitor combination therapies.
With these objectives in mind I'm happy to report that we've recently achieved key milestones in both.
Fair and bracelets that have furthered our progress towards meeting these objectives and brought us closer to the initiation of a registration study.
The first of these milestone came from they aware one window of opportunity study in early stage breast cancer. This.
This is a study being conducted by salty and represents the first use of our clinical supply agreement with gross.
Sure.
Last quarter I spoke about how pleased we were to have doubled the number of centers. The study centers as such an achievement would likely lead to rapid patient enrollments today EGSM approach that this was in fact the case as we enrolled 24 of 30 patients, including all of the patients in the studies first two cohorts.
Now completion of enrollment.
And in these first two core EPS is particularly noteworthy as these patients like those enrolling embraced slipped one of the hormone receptor positive hertwo breast cancer subtype with and without T. centric, allowing us to measure the contribution of the checkpoint inhibitor.
This progress has been further bolstered by the recently announced.
Sounds compelling data from the completed sets of cohort one patients presented at this year's since the meeting.
These data demonstrated the ability of pillar, we are up without checkpoint blockade to reverse the immuno suppressive tumor microenvironment and suggest that tele rep treatment may have long lasting anti cancer immune memory effects.
Typically the data showed that Hello rail rep treatment led to.
Tumor specific replication in all observed subjects at a level that was dramatically higher than we've seen in any other study.
Now this high level of replication may explain the single agent activity in minutes had breast cancer. We previously reported addition.
Additionally, we.
We observed an average 14 fold increase in intra tumoral CD eight positive T cells and the generation of new presumptive antiviral and anti tumor T cell phones that may facilitate a long lasting immune memory effect. This.
This is the clearest evidence we have generated to date that the virus can promote pro inflammatory tumor environment.
Where one data.
Also showed that 70% of cohort one patients saw an increase in cell till the study's primary endpoints and a measure of tumor inflammation that is associated with favorable clinical outcomes.
Celtel response is particularly encouraging given the absence of a checkpoint blockade therapy.
Cohort one.
These results add to aware ones were both robust data set which also includes data that confirms Hillary reps immunotherapeutic mechanism of action.
Demonstrates its potential to synergistically combine with checkpoint inhibitors and support the clinically clinically utility of T cell corn Ali as a blood based.
Biomarker that may allow us to select and to stratify patients who are more likely to respond Hello, Europe based treatments in our pivotal studies.
To summarize.
The data from 50 help to answer one of the questions from our R&D to 13 study can reaccelerate a rep generates an adaptive T cell.
Immune response that educates patients immune system to fight their cancers.
With a 14 fold increase in intra tumoral cdeight positive T cells, and with 70% of patients showing an increase in Celtel. We now believe we have definitively shown just that.
Going forward, having completed cohort two of the wear study we expect.
To answer the question of whether there is synergy between color MRF and checkpoint blockade therapy in breast cancer.
We expect to present data to answer this question at the San Antonio Breast Conference in December.
Moving on now to bracelet on our phase two trial evaluating the safety and efficacy of Hello, Rep based combination therapies in hormone receptor positive hertwo metastatic.
Cancer patients.
Lincoln aware, we've continued to make sustained progress in this trial.
We continue to rapidly enroll patients and have executed our plans laid out during our last call to accelerate the opening of additional trial sites.
To date, we have activated 13 out of 20 sites and are conducting the study under the auspices of trade Cogs World. We're.
Now on research organization we.
We have also successfully completed trial safety run in with the data and safety monitoring Board verifying pellets outstanding safety profile.
Now as a reminder, bracelets design is essentially identical to the design of our prior R&D to 13 study with two exceptions first.
First the study focus is excluded.
Adequately hormone receptor positive her two subsets metastatic breast cancer patients, which is the patient population, which we saw the most pronounced overall survival benefit.
Second bracelet, one adds an additional study arm to evaluate tillery, a rep in combination with Pfizer and Mercks anti PDL, one checkpoint inhibitor that then sale.
This time was.
Was this design was developed in collaboration with Pfizer and Merck Kgaa to support the overall survival advantage observed in R&D to 13 by demonstrating pellet rear EPS ability to induce an anti tumor immune response in a near identical patient population.
Additionally, the study aims to validate T cell clonality utility as a clinical biomarkers.
And evaluate the efficacy of Pella, Rio Colorado Rep checkpoint inhibitor combination therapy.
Together bracelet and wear make up the core of our lead breast cancer program. This program has been substantially de risk by the compelling data. These trials are produced to date as well as our prior regulatory achievements. These achievements include fast track designation and especially.
Protocol assessment part metastatic breast cancer program.
Continued progress made in bracelet in Warewash trials has us on track to meet the clinical objectives needed to initiate a registration study and leaves us well positioned for since gains near and long term success.
Now I'd like to shift gears, a bits and talk briefly about our investigators.
On styrene study.
The first spatial has recently dose in the study, which was initiated as an expansion of our breast cancer program in an in new disease subtype triple negative breast cancer.
Immune checkpoint inhibitor therapy is approved for the treatment of triple negative breast cancer. The limitations of checkpoint inhibitors leave a large met on need for these patients.
Response.
This need exists in part because only about 40% of triple negative breast cancer patients have sufficient PDL, one expression to be eligible to receive checkpoint inhibitors at this time.
And if those and of those that are eligible only about half of those are likely respond to these therapies.
Our phase two Irene.
Study.
Seems to address the unmet needs of triple negative breast cancer patients by evaluating peller aircraft in combination with insights anti PDL, one checkpoint inhibitor read a settlement.
The study is supported by prior clinical data showing the systemic pelerin Rep administration trying the adaptive immune response and in.
Interest rates to PDL, one expression across multiple breast cancer sub types.
Skated demonstrates the potential appeal colonial rep increased the number of patients that are eligible for and can respond to checkpoint inhibitors and highlights the market opportunity that exists for pillory rep. In this breast cancer subtype.
Moving on I would like now to shift the discussion away from our primary focus in metastatic breast cancer and speak a bit more about work has been done with pelerin wrapped in additional indications.
As we announced earlier this week and upcoming oral presentation at the 2020 Society of Neuro oncology annual meeting will feature data from Rio Glioma.
Recently completed investigator sponsored phase one b trial.
This trial evaluating the combination of Pella in granular site macrophage colony stimulating factor alongside standard chemo radiotherapy and agile intelligible mine for the treatment of newly diagnosed glioma multiforme or GBM.
Data in the presentation of course.
Earning abstract show that this combination therapy is safe and well tolerated newly diagnosed GBM patients and we are eager to share additional data related to the combinations efficacy at the conference later this month.
Now before we move onto our next section I want to extend my gratitude to the University of Leeds cancer Research UK and the brain tumor.
Charity for designing managing and funding the real clear trial.
With that I'll now hand, the call off to Andrew to discuss our BD efforts and how these have driven some exciting investments and our Gi cancer program Andrew.
Thanks, Matt.
As we mentioned in the past there is a growing interest from large pharma and biotech companies.
First proving the efficacy of checkpoint inhibitors.
Pairing them with Oncolytic viruses.
This has been marked by several deals by companies such as Merck BMS and JNJ, which have typically been preceded by initial collaborations designed to evaluate the feasibility of potential combinations. This.
This is the exact approach oncolytics has been taking.
We leverage our robust and growing clinical data sent to foster relationships with large pharma and biotech which have led to our ongoing pellet Reramp studies designed to evaluate potential synergies with roche's to centric.
These are murky jays been Enzo BMS, opdivo and insights rented Panama.
The latest example of our ability to execute.
This approach comes from the recently announced goblet trial, which is a phase one two trial being conducted in collaboration with Roche and show a leading academic co-operative medical oncology group based in Germany.
Goblet is designed to evaluate pantelleria wrapped in combination with roche's anti PDL, one checkpoint inhibitor to centric.
Only patients with metastatic pancreatic metastatic colorectal and advance cancers.
The study aims to address a large unmet need similar to the one being addressed by the Irene study, Matt mentioned earlier.
There are approximately $4.8 million global jet cancer cases annually and approximately 80% of Gi cancer.
Patients do not respond to checkpoint inhibitor therapy.
Often due to immunosuppressive tumor microenvironment.
These limitations of checkpoint inhibitors combined with Poudrier EPS promising early clinical data set in colorectal and pancreatic cancer highlight a compelling market opportunity for power wrapping dji malignancies.
Prior clinical.
Studies have shown rapid maturation of dendritic cells increased activation cdeight positive T cells and upregulation of tumor PDL, one expression following peller Europe treatment of cancer patients.
These data highlight pillory or EPS potential to increase the number of patients respond to checkpoint inhibitors in these indications.
Further we've previously.
Nickel reported data from early clinical studies, showing a greater than 90% clinical benefit rate in kras mutated colorectal cancer patients and a greater than 80% increase in progression free survival in pancreatic cancer patients with low levels of C. Chem six expression.
These data in pancreatic cancer, we are particularly compelling as.
The loudest identify seek mpsix as a predictive biomarker of resistance to rewrite.
The Goblet study is therefore designed to confirm both the utility of Seekamp six and to some analogy as biomarkers in Gi cancers, which will be critical as we move towards later stage trials.
I mentioned earlier, the ability to selective and stratify patients who are likely to respond to treatment improves their chances of success and enabled us to be more cost efficient and enrolled troms faster, which get those two potential value inflection point sooner with greater financial flexibility.
Looking ahead, we are eager to continue.
As we advance into goblet study and we expect to begin dosing patients in the first half of next year.
As a whole the checkpoint inhibitor Mark is expected to reach $25 billion annually by 2022. Despite the low response rates, we have been discussing throughout this conference call.
Our extensive clinical dataset demonstrating gallery, our EPS ability to.
Menus innate and adaptive immune responses highlight its potential to improve these response rates and accelerate the growth of checkpoint inhibitor companies.
This is driven exciting business development opportunities across our pipeline highlighted by bracelet aware Irene goblet and our ongoing study with BMS devalue Impella Reramp Opdivo combination therapy.
In the multiple myeloma patients.
Ultimately it is our goal to leverage relationships such as these to secure global clinical and commercialization partnership to both facilitate hillary or EPS approval and maximize its commercial opportunity.
We expect the continued advancement pillory Rep particular in our lead breast cancer program to drive us towards.
In this call by advancing our ongoing discussions with potential partners across the pharma and biotech industries.
With that I will turn the call over to Kirk luck, our CFO to discuss our financial results for the quarter.
Yeah.
Thanks, Andrew and good afternoon, everyone.
I'm very pleased to report that uncommon oncolytics.
According to the strong financial position as we advance pillar rear up towards registration.
Now our cash and cash equivalents as of September Thirtyth, 2020 were $26.7 million compared to 12.3 million as of September Thirtyth 2019.
This includes gross proceeds of 3.6 million.
From our at the market facility, which we established last quarter, pushing our financial runway to the end of 2021.
Our operating expenses for the third quarter of 2020 were $2.5 million compared to $1.8 million in the third quarter of 2019.
This change is largely due to an increase in our investor relations.
Emissions activities, along with an increase in our directors and officers insurance premiums.
Now our research and development expenses for the third quarter of 2020 were $3.9 million compared to $1.7 million for the same period last year.
During the current quarter. In addition to progressing are aware one of the first at once.
One studies, we also completed a cgmp production run along with the associated release testing.
We also incurred costs connected to changes in personnel and expansion of our US office all of the support of our clinical program.
Finally, our net loss for the third quarter of 2020 with $6.7 million.
Callers compared to $3.5 million in the third quarter of 2019.
Equating to a net loss of 16 cents per share for both the 2020 than 2019 periods.
With that I'll hand, it back to Matt.
Thank you Kurt.
Before we move to the.
Acuity I wanted to talk briefly about our recent corporate associated with that we're pretty excited about.
Last month, we announced that Dr., Richard bile a world renowned expert in key opinion leader in Oncolytic viruses adoptive T cell therapies joined our scientific Advisory Board.
Dr. Bal is a professor of immunology at the Mayo clinic director of males immuno oncology and Jean.
Virus therapy programs and co director of the cancer Immunology and immunotherapy program. His research specializes in Oncolytic viruses, but also adoptive T cell therapy, such as car T cells and the potential synergistic interactions between these oncolytic viruses and adoptive cell therapies.
Dr involves extensive.
And Barry and setting Pellerito Rep, and let Tim intimately familiar with pillars substantially competitive advantage over other oncolytic viruses once.
One such advantages pillar EPS ability to be administered systemically by nursing staff without the need for special handling procedures. This.
This differs from other oncolytic viruses that often require intra tumoral administration endorsed.
Special handling due to that EPS health reclassification.
Further pillows systemic administration route facilitates its delivery and select for application in both local and metastatic tumors and it remains the only barley text short survival advantage in late stage metastatic breast cancer patients.
These characteristics together with.
The guidance of Dr. vial and the rest of our leadership team leaves us well positioned as we work to demonstrate the ability of Hillary a rep to synergistically combined with additional immunotherapeutic agents and increase the number of patients responding to such therapies.
Looking ahead, we expect to continue achieving a steady cadence of value, creating milestones through to the sustained advanced.
On some of our diverse clinical pipeline.
We continue to steadily progress towards a registrational study in our lead hormone receptor positive hertwo negative metastatic breast cancer program, while simultaneously executing on additional studies that broaden pelletier ups commercial opportunity.
This execution in turn drives the continued development of our industry partner.
Which deliver additional value to our stakeholders.
Our ability to consistently execute on our goals despite the unpredictable and industry wide challenges posed by COVID-19 speaks to the extraordinarily dedicated and talent of our employees and partners.
Im confident that we will continue to build on this positive momentum as we generate value for our shareholder.
And most importantly improved the lives of our patients with that I'd now like to open the lines to take some questions operator.
Certainly at this time I would like to remind everyone in order to ask a question. Please press Star then the number one on your telephone keypad.
We will pause for just a moment chicken public unit around.
Albert.
Your first question comes from the line of John Newman from Canaccord. Your line is open.
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Hi, guys. Good evening, Thanks for taking my question so.
Hi, I'm wondering if you could just remind us why showing increased.
Yeah, So T cell excuse me clonality.
With pellet for Europe.
Can you wear one study.
It is important and what it potentially indicates the therapy is doing especially in the absence of checkpoint inhibitors in cohort one thanks.
Okay. Thanks, that's a great question. So my way of background cells Hill is a pathological assessment. So the pace will have a biopsy at baseline and end point later on and really what sell till tells you is the level of cellular already aware based.
Basically the number of cancer cells as well as the number inflammatory cells. So.
We see a decrease in the cancer cells due to license or immune targeting of them. It.
Equals the cellular already decreases and if we see an increase in inflammatory cells. It goes up and the net effect is you end up with a positive celtel score.
What this really tells us in patients, especially notably in breast cancer.
Presence or.
If I may the absence of T cells really is prognostic of a core outcome and really what that tells you is there's no inflammatory cells. There is no NK cells are sort of T cells.
Within the tumor so the immune system is completely blind to this tumor. So these patients tend to have very poor prognosis.
By increasing sell till score and doing so so drew.
Medically in the vast majority of patients what it tells US is the immune system now is aware of the tumor its trafficking. These pro inflammatory cells into the tumor to counter.
Good.
The growth of the tumor and also we're getting a decrease in cellular already so what that means is between the virus and the immune cells. It's eliminating.
In the cancer cells within the tumor so the Celtics score as a very positive tool at a very powerful tool to tell us how well patients are doing and what we're seeing from some of the early.
Immunology at amino mass cytometry, we.
We actually are getting expansion of T cells within the tumor so T cells.
Resident within the tumor we're seeing those expand and presumably then those are anti tumor T.
T cells are the other thing that's coming out of the aware study.
We should actually take the immune system at baseline.
And again at day 21, when the surgery is done and we can apply that to the tumor of the patients and what weve.
Remained is theres no recognition of the tumor at baseline and incredible rack a recognition by the release of chemo cranes and cytokine is notably interferon Gamma W.
The immune system has learned to recognize and target and this is very important for these patients because what we want to establish and I think we have established now in this cohort one we have.
From memory cells that recognize the tumor that will be with these women for the rest of their life and hopefully are able to challenge our micro metastatic disease and recurrence of disease. So that these women have a much better long term outcome.
Okay.
Okay, Great and can you also talk about.
The.
The differences that are seen when you think about what has been shown in the past with some of the.
PD one inhibitors.
I'm showing an increase in.
So until versus what you're seeing with Hillary rep.
On its own.
Showing an increase in cell till thanks.
What weve presented previously in animal models and I expect this to be the case and it you know the real meets everywhere study was cohorts one and two I mean, you can see this because its reflective of the target patient population, but it's also the only cohorts that have 10 patient.
Each the rest of them have five or six so you know that the study was very much weighted to those cohorts.
What we're seeing as compared to what you would see with checkpoint inhibitors is we're getting.
Rapid expansion of T cell clones checkpoint inhibitors with the exception of detailed before really don't crime very much they don't actually generate new clones. They just activate the existing.
Hi, good ones.
But what we've seen in early animal models, when we treat with railcars, we get pro inflammatory cells, but we also get accumulation of some T Reg, which are basically slowing or breaking the means and if you will as well as M.D.S.C. cells, which have very similar role in promoting anti inflammation when.
When we add checkpoint inhibitors to the tumor what we find in animal models that lease is we mean that maintain that high level of inflammation with accumulation of CD eight positive cells, but in the presence of the checkpoint inhibitor where.
The gating or eliminating the T. Reg from the tumor so we're getting a much more pro inflammatory event and what we're hoping is.
Yeah.
Well, we'll see the same thing in human patients what we'd like to see in cohort. Two is the same level of celtel, if not higher but.
But more of the pro inflammatory immune cells, rather than that accumulation that T. Reg and early evidence, which suggests that is the case.
Okay, great. Thank you.
Thanks for the question.
Once again, if you would like to ask a question. Please press Star then the number one on your telephone keypad. Your next question comes from the line of warnings you.
Leave from Ladenburg Your line is open.
Hi, Thanks for taking my question I was my question.
About oh well worn.
Data just what do you think any.
The contribution from the larger though in the quarter warrant food.
And those who are I think you maybe you mentioned it but what do you think you will when do you think you will report data for the quarter too.
Oh, new.
And then my question. Thank you.
So to answer your second question first yes, the plan for San Antonio as Tim really compare and contrast cohort one and two because I think that sets the stage for the registration study I think it sets the stage for what we can expect coming out of the bracelet study.
So.
Yes, it will be an important presentation for us and that's in San Antonio We now have confirmed that we do have three presentations in San Antonio and Wednesday Forgive me what was your first question.
So do you think is there any role of the Lantus, who reached out to you showing at the recent presentation.
And.
Because it was quite a one to us who the patients also had a ledger, though right. In addition to pilot.
We spoke with the investigators about that's in their previous investigations into Celtel like consulting group is actually the group.
That's defined and created that the sell tools.
Score so they're arguably the most familiar with in the world. There is no assumption that luxury is always going to have any effect in terms of trading in a pro inflammatory events. The reason that was included is this study.
Hi.
It's a basically a neoadjuvant study or window of opportunity.
Today. So we're taking these healthy women and they get standard of care and and we add additional ages on top of that.
Because obviously, they're hoping to get some shrinkage or changes to their tumor we do have to combine with standard of care otherwise it would be an ethical buttons.
But in speaking with the investigators in their own examinations of Delta Letrozole does not.
Impact negatively or positively the central square and meaningful way.
Got it helpful and last question.
Yes, it's the one starts to be.
Do you have any further color.
In terms of timing for can you just didn't report.
For I'm.
Actually which study.
The press release.
Okay, great bracelets actually enrolling really well we anticipate.
The completion of enrollment first.
First half of next year.
We will be reporting hopefully near final data by San Antonio next year.
That means that we are hoping to get additional data read outs, but that's in conjunction with Pfizer a co development partner.
So they'll have to approve that.
Okay got it.
There are no further questions at this time I now turn the call back to Mr.
Sorry coffee for closing remarks.
Well, thanks again to everyone for joining us on the call. We look forward to the continued advancement of our clinical program and we'll keep everyone updated along the way. Thanks so much.
That concludes today's conference call you may now disconnect.
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Oh.
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