Q3 2022 Oncolytics Biotech Inc Earnings Call

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Good morning, and welcome to oncology biotech third quarter 2022 conference call. All participants are now in a 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 and I would like to turn the call over to John Patten Director of Investor Relations and Communications. Please go ahead Sir.

Thank you operator, and good morning, everyone earlier. This morning, all clinics issued two press releases one announcing in June and results from the pancreatic cancer cohort in the Companys phase once you've got that trial.

Second providing recent operational highlights and financial results for the third quarter 2022.

The announcements highlights provided in these press releases will be the topic of today's call.

So eventually available on the events and presentations section of the critics web site 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 contains certain forward looking statements relating to the company's business prospects and the development and commercialization of Colorado.

Any statements regarding the company's focus strategy and objectives.

These beliefs as to the potential in motive action of telling me as a cancer therapeutic.

Design Ayman debated benefit.

Company's current any clinical trials any anticipated timing at least an additional data company's plans and expectations regarding potential Registrational study company's business development plans and strategies and other statements relating to anticipated developments in the company.

These statements are based on management's current expectations and beliefs and are subject to a number of factors.

No risk 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.

Any forward looking statement.

Yes, it's an expectation or belief educate yourself.

Expectations or beliefs are expressed in good faith.

We've got a reasonable basis, but there can be no assurance that these statements of expectations or belief will be achieved in.

These factors resulted current or pending clinical trials risks and actual property protection financial projection packages by regulatory agencies and other factors detailed in the company's filings with the SEC.

<unk> does not undertake any obligation to update these forward looking statements, except as required by applicable law.

Speaking on today's call will be on critics, Chief Executive Officer, Dr. Matt Coffey, Chief Medical Officer, Dr. Tom Heckman.

Our head of business development, Andrew <unk>, and Chief Financial Officer, Kirk look with that I'll now turn the call over to Matt. Please go ahead.

Thank you John and good morning to all who have joined US today I'll begin by getting right to the exciting news reported earlier this morning, which came when an abstract with interim data from a goblet trial was published as part of the <unk> annual meeting.

These data showed an objective response rate or <unk>, 70% intend to valuable pancreatic cancer patients treated with the combination of pellet Ria Rep checkpoint inhibitor cheese, all of the map and the chemotherapeutic agents Gemcitabine and Nab Paclitaxel.

This <unk> is nearly three times greater than the average or RFC and historical control trial, which is about 25%.

These remarkable results for broader pancreatic cancer program to a pivotal trial readiness as.

As we are now planning to announce pillory, Iraq pillar as well refer to it into a registrational study for this indication pending discussions with regulatory authorities.

With our pancreatic cancer program that representing our second near term Registrational opportunity to go alongside our breast cancer program. We believe we have transformed <unk> value proposition and we're at a true inflection point in the company's history.

We have a rideshare guided by our clear strategic focus and commitment to data driven approach that how does collaborating with industry leaders to selectively pursue therapeutic opportunities beyond our lead program.

This approach to enable us to keep our efforts in breast cancer on track, while simultaneously building a robust proof of concept data set in pancreatic cancer.

We now have two pillars upon which we can build a registrational program going forward.

With regards to our breast cancer program, we are increasingly enthusiastic about its prospects at upcoming milestones chief.

Chief among these potential value drivers will be the disclosure of an expansive dataset from bracelet one at a major medical meeting in the first half next year as a reminder, bracelet. One is a randomized phase II trial in HR positive <unk> negative metastatic breast cancer.

It includes cohorts evaluating paclitaxel monotherapy.

Paclitaxel plus pillar.

And Paclitaxel plus pella in combination with PD, one checkpoint inhibitor.

Those of you familiar with analytics have likely heard me refer to bracelet, one as pellet last major step on its path to a registrational breast cancer study.

The data generated by bracelet, one are expected to inform the design of a pivotal trial, while simultaneously validating our prior data.

Our positive her two negative breast cancer, which provides a robust foundation for the program.

These include the results of the randomized phase II trial in <unk>, Turkey, which showed a statistically significant near doubling of overall survival in HR positive <unk> negative breast cancer patients.

And with Pella combined with Paclitaxel versus those treated with Paclitaxel alone.

These data showing <unk> ability to drive meaningful clinical benefit contributed to a special protocol assessment from the FDA, which means <unk> 13 counts as one of the two pivotal studies required for approval.

Additional data form the foundation of our HR positive <unk> negative breast cancer program includes phase one results demonstrating pellet single agent activity as well as results from aware one trial demonstrating in characterizing it would be logical mechanism of action.

Prior to reporting bracelet, one finance, we also expect to report additional data from <unk> as well as the results of our Chinese partner, Italy, North Sea is bridging trial, it HR positive <unk> negative breast cancer.

Both of these are announcements are expected later this quarter.

As we move forward in 2023 and beyond we will aim to replicate our recent success by maintaining our core focus on our near term registration opportunities in HR positive <unk> negative breast cancer and pancreatic cancer, while selectively exploring additional indications primarily through partnerships or collaborations.

Achievements engaging with regulators and seeking regulatory input on the registration program for breast cancer, which we expect to be able to discuss in more detail.

First half of 2023 breast cancer will remain a crucial part of <unk> story and our value proposition going forward. We believe we are closing in on our goal of delivering treatments that improve the lives of cancer patients and are excited for what's ahead.

Having completed that high level overview of HR positive <unk> negative breast cancer and pancreatic cancer to programs, we expected to primarily focus on going forward, Let me hand, the call over to Tom to provide some more insights on the new pancreatic cancer data and after that agile will dig into what this means for our business development Tom.

Thanks, Matt It's my pleasure to have the chance to discuss our new pancreatic cancer data, which as Matt mentioned were published in an abstract earlier today, that's part of the <unk> annual meeting.

These data come from Goblets, a multi indication phase one two trial, we are conducting in collaboration with Roche in AI O, which is an academic cooperative medical oncology group in Germany.

The results published a city or from the trials first cohort enrolled patients with first line advanced or metastatic pancreatic cancer patients.

Patients in this cohort received pellet in combination with a piece of lithium and standard of care chemotherapy, Gemcitabine and Nab Paclitaxel.

As of the Abstracts July 28 cutoff date seven of 10 Evaluable patients in this cohort had achieved a partial response per resist criteria with two more achieving stable disease. This gave an objective response rate in clinical benefit rate of 70% and 90% respectively. We believe.

These results are striking and they markedly exceeded our expectations going into the study for context.

Pre specified success criteria for efficacy in stage, one of goblets pancreatic cancer cohort with three objective responses in 12 Evaluable patients. This landmark was actually achieved with the first three evaluable pancreatic cancer patients and as of the city abstracts cutoff date, we have more than doubled this initial goal.

And only the first 10 evaluable patients.

Furthermore, historical data from trials evaluating the combination of Gemcitabine and Nab Paclitaxel showed an average objective response rate of only about 25% almost three times less the objective response rate reported in our city abstract. Prior studies also showed the checkpoint inhibitors are unable to benefit the vast majority of.

Pancreatic cancer patients. If these agents only improve outcomes and persons classified as MSI high Unfortunately, MSI high patients represent less than 1% of total pancreatic cancer population.

Given the limited efficacy observed in each of these aforementioned historical settings goblets interim results strongly suggest that pellet synergistically combined with checkpoint inhibitors and chemotherapy to drive tumor responses in pancreatic cancer.

This is noteworthy as objective response rate is known to correlate with survival and has even been used as a registrational endpoint in certain oncology indications.

Moreover, prior clinical data in pancreatic and other cancers have demonstrated <unk> ability to activate an anti cancer immune response and reversed the immunosuppressive microenvironment that limit the efficacy of checkpoint inhibitors.

These earlier results collectively provide strong mechanistic support for goblets interim results.

Increasing our enthusiasm for the pancreatic cancer program.

Looking ahead for this program.

We plan to discuss our results with regulators with the goal of enabling advancement into a registrational study.

Rather than into goblets optional stage two expansion trains. We believe this approach represents the best strategy to address the urgent needs of pancreatic cancer patients given both the strength of our data and the limited efficacy of currently available therapies.

Lastly, before handing it off to Andrew I wanted to briefly preview our upcoming poster presentation at city later this week.

<unk> will include updated data from stage, one of goblets pancreatic cancer cohort, which was designed to enroll a total of 12 evaluable patients versus the first 10 reported in the abstract today.

These updated results will also be discussed or your virtual kols event, a week from today on Monday November 14th.

Which will give viewers the opportunity to hear expert.

Commentary from three key opinion leaders and our data and on the current pancreatic cancer treatment landscape.

It will also include a question and answer session and I highly encourage courage all listening now to join US next week using the link available on the events and presentations section of our website.

I'll now turn it over to Andrew to discuss how our recent clinical results are driving your business development efforts and corporate strategy Andrew.

Thanks, Tom.

We are in the midst of a very exciting time for oncologic BD team as our recent data in pancreatic cancer are substantially enhance pallets potential licensing value proposition.

Given the pancreatic readout and our existing clinical data set in breast cancer.

We can now offer potential partners to near term registration opportunities that we believe have a high likelihood of technical and regulatory success.

Further first line metastatic pancreatic cancer and HR positive hurt you breast cancer represents two highly attractive market opportunities.

Which I'll discuss in more detail now.

Looking first at HR positive <unk> negative breast cancer.

<unk> indicate that there will be approximately 300000 drug treatable cases in the U S major European markets, and Japan by 2028 and.

Despite the limited benefits current therapies can provide.

Drug sales in the HR positive <unk> negative breast cancer subtype are expected to grow from $11 billion in 2020 to 31 billion by 2030.

Thanks, <unk> 13th results, we already have a randomized dataset demonstrating <unk> ability to improve patient outcomes in this indication and that will count as one of the two trials required by the FDA for registration.

With bracelet, one upcoming readout, we aimed to validate this finding with a second randomized dataset.

Which we believe would leave Palo well positioned to capture a substantial portion of this market. Following a subsequent registrational study and potential approval.

Turning our attention to pancreatic cancer.

Estimates indicate that there will be approximately 135000 metastatic first line drug treatable cases in the U S major European markets and Japan by 2028.

This represents the patient population being valued in our goblet trial.

Jan this prevalence another aspect of pancreatic cancer that makes it valuable commercial on partnering opportunity is the significant unmet need and lack of past successful innovation in this indication.

Cancer patients are typically treated with regimens composed of older chemotherapeutic agents, such as Jim cited beam and Nab Paclitaxel.

Unfortunately, only about one in four patients will respond to these regimens and those that do response, you only modest survival benefits.

For example, the combination of Gemcitabine and Nab Paclitaxel, resulting in a median overall survival of less than nine months in a randomized phase III trial of over 860 metastatic pancreatic cancer patients.

Despite the best efforts of researchers across academia biotech and pharma.

These older minimally effective treatment regiments currently remains the best option for the overwhelming majority of pancreatic cancer patients.

Even PD one PDL, one checkpoint inhibitors, which have revolutionized the treatment of numerous cancers are unable to effectively treat the 99% of pancreatic cancer patients were not classified as MSI high.

Taking all this into consideration when can appreciate the significance of our goblet data.

Which suggest Palo maybe the key to unlocking the potential of checkpoint inhibitors in pancreatic cancer.

Therefore, we believe <unk> successful development could transform the standard of care in this indication.

Opening up a large new market opportunity and leading to drastically improve clinical outcomes for patients.

To enable our effort to pancreatic and breast cancer. Our BD team is focused on securing a global clinical and commercialization partnership with a leading Biopharma company.

As we work towards this goal.

We're fortunate to have established relationships with several industry leaders, including Pfizer Roche, Merck Serono, Bristol Myers Squibb and insight.

Our collaborative trials with these major players have a lot each to become intimately familiar with power, which we believe will serve us well in any partnering discussions.

While we can't predict the timing of any potential partnership we will be thoughtful and diligent as we seek to achieve the best possible outcome from political and its shareholders.

Our plan is to pursue a single licensing deal for both of our breast cancer and pancreatic cancer programs.

Just to minimize our clinical and commercial risk, while providing upside through upfront payments milestones and royalties.

By leveraging our Cardinal maturing data from the <unk> 13 price at one and goblet trials, we intend to create competition among potential partners and drive continued interest.

Given the clinical data, we've generated and the attractive commercial opportunities offered by our breast and kept pancreatic cancer programs.

We believe we are ideally positioned to execute on our BD objectives.

We plan to provide additional updates as appropriate and look forward to moving forward with pellet newly enhanced value proposition.

Next I will turn the call over to Kurt to discuss our Q3 financial results Kirk.

Thanks, Andrew.

I'm pleased to say that <unk> continues to operate on a sound financial foundation with an anticipated cash runway beyond 12 months and through several important milestones based on our current projections.

These milestones most notably include a readout on overall response rates progression free survival and evolving evolving overall survival data from Brexit, one which is expected in the first half of next year.

Turning to our financial results Onkelinx finished the third quarter of 2022 with $32 4 million in cash and cash equivalents compared to $41 3 million in cash and cash equivalents as of December 31 2021.

General and administrative expenses for the third quarter of 2022 were $2 4 million compared to $2 9 billion in the third quarter of 2021.

This change was mainly due to lower investor relations activities as the current global business conditions have negatively impacted market sentiment for the biotech industry and the overall markets.

Research and development expenses for the third quarter of 2022 were $3 $7 million compared to $3 three in the third quarter of 2021.

This change was mainly due to our clinical development program, primarily from a net increase in our clinical study costs.

Compared to the third quarter of 2021, we saw higher goblet patient enrollment and sample analysis activities this quarter.

This increase was offset by lower bracelet, one patient costs as bracelet entered into the re treatment and follow up phase upon reaching full enrollment at the end of the last quarter.

The net loss for the third quarter of 2022 was $4 4 million compared to $4 9 billion for the third quarter of 2021.

This equates to a net loss of <unk> <unk> per share for the third quarter of 2022, and <unk> <unk> per share for the third quarter of 2021.

Now with that review of our third quarter financial results complete I'll turn the call back over to Matt Matt.

Thanks Kurt.

Before providing some brief closing remarks I wanted to take a moment to recognize the recent appointment of Jonathan Rigby to our board of directors.

Jonathan is a seasoned industry veteran with over 30 years of experience in the pharmaceutical and biotech sectors.

He currently serves as the group CEO of or below Biotherapeutics and was a co founder of <unk>, Inc, which was acquired by UCB earlier. This year in a transaction valued up to approximately $1 9 billion U S. Dollars. We are confident that Jonathan has extensive commercial and business development expertise will be invaluable as we.

Entered the next phase of our corporate evolution propelled by the new data from goblets pancreatic cancer cohort.

These data have added a second near term registration opportunity to our pipeline, allowing us to derisk, our binary events in pivotal trials and improve our position as we pursue potential partnering discussions.

You can just step back we can also appreciate how goblet data validate our overreaching clinical development strategy. This strategy seeks to leverages pellet multifaceted mechanism of action to address one of the longest standing problems oncology, namely the inability of immune cells to recognize infiltrates and destroy tumors.

On past, earning calls you've heard me speak about how data from trials, such as <unk> demonstrated <unk> ability to generate immune cells that recognize and shell tumors, while simultaneously remodeling tumor microenvironment to promote immune cell infiltration.

This positions <unk> as a platform molecule that can synergistically enhance the efficacy of a broad range of drug classes, such as checkpoint inhibitors chemotherapy, where car T cells, enabling it to potentially improve the therapeutic outcomes in a wide range of indications.

Moving forward, our near term registration opportunities in breast and pancreatic cancer will be our primary focus while efforts beyond these programs will be enabled predominantly through partnership or collaboration.

This approach will allow us to operate with capital efficiency as we seek to further unlock pellet expansive therapeutic potential.

Finally, before opening up the call for Q&A I, just wanted to reiterate my excitement, but we're on clitic sits today and thank all those who have brought us to this point.

I'll start first and foremost of the clinical trial participants who remain a key source of inspiration for the company.

Also express my gratitude for the support of our shareholders and the amazing work done by our employees collaborators and investigators.

Their contributions that allow us to advance pellet development and pursue our mission of improving the lives of cancer patients with that we will begin the Q&A session operator.

Thank you Sir.

Ladies and gentlemen, if you would like to ask a question. Please press star followed by one on your Touchtone phone you will then hear Sweden.

Acknowledging your request and if you would like to withdraw your question from the queue. Please press star two and if you're using a speaker phone. We do ask that you. Please lift the handset before pressing any Keith. Please go ahead and press Star one now if you have any questions.

And your first question will be from John Newman Canaccord. Please go ahead.

Hey, guys. Good morning, really interesting goblet, David here, just had a couple of questions just.

Just curious.

In terms of the next steps here going forward.

What might a.

<unk> study look like just roughly speaking in terms of.

Clinical design I'm, just wondering if it would be.

Sort of.

Chemotherapy, plus checkpoints, plus or minus Palo via rep, or if maybe there is sort of some different designs and considerations that you have thought about overtime here. Thanks.

Hi.

Thanks very much for the question. This is something we've obviously debated quite a bit and we'll provide more color on.

During the Kols presentation next week I would like to remind everyone that we are hosting our kols call a week from today, where that's exactly the type of question will we get it into.

Tom could you maybe provide a 10000 foot sort of look at what we've generally discussed in terms of.

At adaptive design or a phase III program roughly some of what those numbers look like.

Obviously, theres a number of stakeholders holders involved in this decision and what the Ultimate study design will look like but.

I think Tom can give you an idea of what our general cuts are Tom would you mind, providing a little bit of color.

Yes sure.

So as Matt said, there there are a number of stakeholders and discussions that need to occur before we land on a formal final design, but our thinking now is running toward.

A phase two three type of design in which we would have a two arm study comparing standard of care.

There are two standard of care plus <unk> plus a checkpoint inhibitor just isn't the goblet study and when I say, a two or three design.

That would mean that we would have.

Look at the data at some.

Appropriate time point.

With the endpoint.

Endpoint trigger too.

Determined whether or not we move on to the study based on the progress of the patients up to that time point now this sort of design is not uncommon and the goal is to Oh Wow.

Our seamless.

Progression towards completion of our licensure, enabling study, while maintaining an appropriate risk level during the conduct of that study.

Yeah.

Interesting, okay, great well certainly have more questions at the Kols that next week. Thank you.

Thank you once again, ladies and gentlemen, if you would like to ask a question at this time. Please press star followed by one on your Touchtone phone.

And at this time gentlemen, we have no further questions. Please proceed with your closing.

Okay.

Thanks to all who joined today to hear about a recent critical data and progress before we go I'll remind everyone that we're hosting a virtual KOL event a week from today to provide expert perspective on inkjet and pancreatic data being presented at Etsy.

Those interested can find a link to the events on the events and presentations section of our website. Thanks again have a great day.

Thank you, Sir ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending and at this time, we ask that you. Please disconnect your lines.

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