Q4 2022 Oncolytics Biotech Inc Earnings Call
Welcome to Onkelinx Biotechs fourth quarter outflows during two conference call.
Participants are now in listen only mode.
A question and answer session at the end of this call. We advised that this call is being recorded at the company's request I would now like to turn the call over to Jon Patton.
Dosing based on relations and communications. Please go ahead.
Thank you operator, and good morning, everyone earlier. This morning, <unk> issued a press release, providing recent operational highlights and financial results for the fourth quarter and full year of 2022.
A replay of today's call will be available on the events and presentations section of the <unk> 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 contains certain forward looking statements relating to the companys business prospects and the development and commercialization of <unk>.
Statements regarding the company's focus strategy and objectives.
These beliefs as to the potential and motive action Palo Europe into cancer Therapeutics.
Alright, and anticipated benefits of the company's current pending clinical trials.
The timing of ability some additional data.
These plans and expectations regarding potential registration studies at these business development plans and strategies, the company's financial Red Lake and other statements related to anticipated developments and the company's business.
These statements are based on management's current expectations and beliefs.
To a number of factors, which involve known risks delays uncertainties.
The uncertainties and other factors 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 statements, which expresses.
Expresses an expectation or belief as to future results expectations or beliefs are expressed in good faith and belief type reasonable basis, but there can be no assurance that these statements are expectation or belief will be achieved.
These factors include results of current and pending clinical trials risks associated with intellectual property protection financial protections actions by regulatory agencies and those factors detailed in the company's filings with the SEC.
Sir.
<unk> does not undertake any obligation to update these forward looking statements, except as required by applicable laws.
Speaking on today's call will be <unk>, Chief Executive Officer, Dr. Matt Coffey, Chief Medical Officer, Dr. Thomas Edelman Global head of business development, Andrew <unk> and Chief Financial Officer.
I will now turn the call over to Matt to begin managements remarks. Please go ahead Sir.
Thanks, John and thanks to everyone joining us this morning.
Looking back over the past year, it's clear that 2022 was a transformational time for our pipeline and company and <unk>.
One that has set us up for another exciting year in 2023.
Emboldened by the accomplishments that youll be hearing about on today's call. We are advancing a pipeline that now includes two high value registrational opportunities for <unk> or <unk>.
We'll call it.
With each representing a core pillar of our business and foundation for growth.
The first and longest standing of these pillars is of course, our HR positive <unk> negative breast cancer program.
Last year, we completed enrollment in the program second randomized phase III trial bracelet, one which is approaching a crucial data readout that we anticipate sharing that a major medical meeting next quarter.
We expect this readout, which Tom and Andrew will discuss in more detail to provide key data that will validate the program's prior positive results and help inform the design of subsequent Registrational trial.
Just to provide some additional accompanying history, our breast cancer programs. Prior positive results come from R&D to <unk> three a randomized phase II trial that counts as one of the two pivotal studies required for regulatory approval of <unk> in breast cancer for a special protocol assessment agreed with the FDA.
R&D $2 13 showed a statistically significant and clinically meaningful near doubling of overall survival in HR positive <unk> negative breast cancer patients, who received <unk> plus paclitaxel compared to those who received paclitaxel alone.
These data build upon phase one results demonstrating <unk> single agent activity in the HR positive <unk> negative breast cancer and also inspired the aware one study, which met its primary endpoint and demonstrated how pella remodels the tumor microenvironment and trains the immune system in ways that may enhance the efficacy of a wide range of oncology treat.
<unk>.
With all these data in place we believe the successful outcome from bracelet, one would represent a key inflection point for our breast cancer program as it would clear the way propellers advancement into a registrational study and bolster our business development activities.
Next I'll turn to our pancreatic cancer program, which emerged as our second core pillar late last year. Following some remarkable proof of concept data from our phase <unk> study presented at 2022 since the annual meeting.
<unk> cancer cohort reported a 69% objective response rate, including a confirmed complete response and 13 evaluable patients treated with the combination of pillar the checkpoint inhibitor at <unk> and the chemotherapeutic agent Gemcitabine and Nab Paclitaxel.
These results generated excitement from our team and key opinion leaders in the field because the average response rate observed in relevant historical controlled trials in pancreatic cancer, it's only about 25%.
The 69% objective response is nearly three times so it would have been expected.
Based on the strength of these data as well as discussions with key opinion leaders and potential partners. We believe the most prudent next step for our pancreatic cancer program is to determine the optimal registration enabling pathway as expeditiously as possible to do this we continue to engage with the FDA granted <unk> fast track designation in pancreatic cancer.
During the fourth quarter and other key stakeholders to align on the optimal design for such a study, which Tom will discuss further.
Looking ahead, advancing our pancreatic and HR positive <unk> negative breast cancer program towards regulatory approval will be our primary focus.
Alongside these efforts, we will selectively continue to evaluate pellets therapeutic potential in additional indications through collaborations with leading industry players and academics. As this was the strategy that allowed us to maintain momentum in our breast cancer program, while bringing our pancreatic cancer program forward as our pipeline second core pillar.
And with that let me turn the call over to Tom <unk> for a more in depth discussion of our clinical programs and business development efforts, we will start with you Tom.
Thanks, Matt I'd like to kick off my portion of the call by setting the stage for what to expect from bracelet, one anticipated readout next quarter.
As a reminder, bracelet one is a randomized phase II trial will be conducted in collaboration with Pfizer and Merck <unk>.
It enrolled patients with HR positive <unk> negative metastatic breast cancer into three distinct cohorts.
First two cohorts mirror the <unk> III study that Matt referenced earlier with one cohort evaluating paclitaxel monotherapy and the other evaluating the combination of Paclitaxel Impella. In addition, the third cohort to evaluate the combination of Paclitaxel Pella and the checkpoint inhibitor of value map.
At a medical meeting next quarter, we anticipate reporting progression free survival and tumor response results from this trial, which was designed to enroll a total of 48 patients.
While enrollment into bracelet, one is complete it should be noted that many patients continue to be followed for critical endpoints.
Some key results of the study, including overall survival will only come into focus as the data mature.
Given its size bracelet, one that is not powered to demonstrate statistical significance between the study groups.
Our successful results from the trial would therefore be to see one or both of the cohorts that include Pella numerically outperformed the paclitaxel monotherapy arm.
Achieving this result would result in the second randomized data set supporting <unk> ability to deliver meaningful clinical benefit to HR positive <unk> negative breast cancer patients further derisking our program as we move towards a Registrational study.
As we look ahead for our breast cancer program. We're also highly encouraged by recent data presented by our partner Ablate, nor paid as last year at San Antonio breast cancer Symposium.
These data were from Adeline single arm bridging trial evaluating <unk> plus paclitaxel in Chinese patients with HR positive <unk> negative metastatic breast cancer.
As you just heard <unk> plus Paclitaxel is the same combination being studied and bracelet one second cohort.
Results from <unk> bridging trial demonstrated this combination is favorable safety profile with Chinese patients.
Tumor shrinkage in 12 of 14, Evaluable trial participants with seven achieving a partial response.
Of the seven patients with partial responses.
<unk> had their responses confirmed by subsequent scans, while two others had potentially confirmatory scans pending notably one patient continued to maintain a partial response after nearly a year following the presentations cutoff date.
And although they are still evolving I would like to also note that the trial is progression free survival results presented at the San Antonio breast cancer cancer Symposium.
Showed a median PFS of nine one months.
These interim results from athletes bridging trial further demonstrate the ability of pellet plus paclitaxel to drive durable clinical responses in HR positive <unk> negative breast cancer patients. We believe this promising findings bodes well for bracelet one upcoming readout.
I'll now speak about our recent results in pancreatic cancer and what they mean for the program moving forward.
These data were presented at the <unk> meeting last year and came from our <unk> study, which is a phase <unk> multi indication trial being conducted in collaboration with Roche and <unk>.
The trial was designed two stages, so that any cohort that achieves a pre specified response rate in stage, one may be expanded to enroll additional patients in stage two.
This map previewed goblets pancreatic cancer cohort evaluated the combination of pellet the PDL, one checkpoint inhibitor, a teaser Lindsay Rab and the chemotherapeutic agents Gemcitabine and Nab Paclitaxel in first line patients with advanced or metastatic disease. We.
We reported an objective response rate of 69% and 13 evaluable patients with eight patients achieving a partial response and one achieving a confirmed complete response, which is quite rare finding in this indication with.
The study combination was also shown to be well tolerated.
To help provide a full understanding of these results I'll emphasize some key points made during a recent key opinion leader webinar, a replay of which can be found on our website.
This webinar feature goblets principal investigator along with two additional pancreatic cancer experts first I'll lymphocytes that achieving a 69% response rate in <unk> pancreatic cancer cohort far surpassed our expectations going into the trial.
As Matt mentioned, the average response rate from pancreatic cancer trials of Gemcitabine, plus Nab Paclitaxel is only about 25% or roughly a third of what was observed we added pillar and a checkpoint inhibitor to this regimen.
Moreover, a number of trials have shown that checkpoint inhibitors only improve outcomes in pancreatic cancer patients classified its MSI high.
It represents only about 1% of all pancreatic cancer patients. This helps explain why older chemotherapeutic regimens, such as Gemcitabine plus Nab paclitaxel.
Remains the standard of care in pancreatic cancer, despite providing a median overall survival of less than a year.
The next point from our KOL webinar that will emphasize since like goblets pancreatic cancer cohort included patients that are quite typical in similar to what would be expected in a randomized registrational trial.
The Evaluable patients 13 had metastatic disease with nine having liver metastases and the average age of the patients was just over 62 years.
<unk> achieved these very encouraging results in a representative population increases our confidence as we move our program towards a registrational study.
And the last point I'll emphasize is that we have a robust set of mechanistic data from prior trials supporting godless results.
Which suggests pella synergistically acts with checkpoint inhibition and chemotherapy to drive tumor responses in pancreatic cancer.
These data have demonstrated <unk> ability to activate and expand anti cancer immune cells, while simultaneously reversing immunosuppressive tumor microenvironment.
Immunologic effects such as these are known to enhance the efficacy of checkpoint inhibition highlighting the scientific rationale for the <unk> study.
Based on <unk> compelling results as well as the unmet need and current treatment landscape in pancreatic cancer, we have chosen to forego the stage two expansion phase for the trials pancreatic cancer cohort. So that we can move directly towards a registrational pathway.
Given the clear signal of activity, we've seen in <unk> pancreatic cancer cohort to date. We believe this is the most clinically appropriate next step for the program and one that is in the best interest of patients.
To enable the advancement of our pancreatic cancer program to a randomized trial, we are gathering input from regulators and other key stakeholders on the optimal design for its next trial.
And as we work to do this we will benefit from our pancreatic cancer programs recent fast track designation from the FDA. This designation will provide us with the opportunity to communicate more frequently with the agency about our data and planned development pathway. It also provides a degree of validation for godless interim results since <unk>.
<unk> fast track designation required therapy show some advantage over available treatments such as superior effectiveness.
While it's too early to share the specifics of what <unk> pancreatic cancer trial will look like what I can say now is that we are envisioning a randomized phase II study with an adaptive design ideally. This design would allow a seamless progression from an interim analysis to an expansion phase designed to support a regulatory.
File.
We look forward to our continued work designing this trial and to sharing more details once they are finalized.
Lastly, before handing off the call to Andrew I would like to remind all listening and in addition to its pancreatic cancer cohorts. Goblet also includes cohorts and valley evaluating Pella, a teaser Lindsay map combinations.
Steady colorectal and advanced anal cancer.
We expect to have additional updates from these cohorts over the course of the year.
And have been pleased with the overall enrollment to date.
With that I'll now ask Andrew to speak about our business development efforts Andrew.
Thanks, Tom I'll start by building off a point, Matt may at the top of the call, noting how 2022 was a transformational year for palace potential licensing value proposition.
By adding <unk> recent data in pancreatic cancer alongside <unk> 13, statistically significant results in breast cancer, we've provided Palo with a second registration opportunity that has significantly derisked by differentiated clinical data.
Moreover, Egypt pellets potential registration programs provides a robust market opportunity for prospective partners for.
For HR positive <unk> negative breast cancer estimates indicate that there will be nearly 300000 drug treatable patients across the U S, Japan and major European markets by 2028.
Looking at first line metastatic pancreatic cancer the number of drug treatable patients is expected to reach $135000 in the same timeframe.
With addressable markets of this size and clinical data demonstrating <unk> potential to substantially improve upon standard of care. In these indications. We believe we are well positioned as we pursue a single licensing deal for both of our breast and pancreatic cancer programs.
Feedback from our conversations with potential partners bracelet, one evolving results will be a crucial component of the dataset supporting any deal.
As we work towards a licensing agreement for pellets rights in the U S Europe , Japan and elsewhere. We are pleased to have already partnered with <unk> on its development and potential commercialization and certain agent territories, such as Singapore, South Korea, Hong Kong, Taiwan and China.
As the world's second largest and fastest growing pharmaceutical market.
Outlet recently took an important step to accelerate pellet development in China.
The results from the bridging trial, Tom discussed earlier in the call.
With these data showing that pellet plus paclitaxel is well tolerated and generated durable responses in this study.
<unk> now has the opportunity to interact with Chinese regulators to discuss potential registrational approaches for Birla in this jurisdiction.
In addition, the positive results of the bridging trial are expected to allow for the inclusion of data from the <unk> hundred 13, and bracelet one in that link future regulatory submissions, thereby expediting pellet path to approval in China.
Now before handing the call to Kurt to review, our annual financial results I'd like to reiterate our enthusiasm for the outlook of our BD prospects and remind everyone that due to the nature of licensing discussions and our commitment to drive competition between prospective parties. We are unable to predict the timing of any potential partnership.
That said I will again note there ongoing interactions with prospective partners have indicated is showing meaningful data from bracelet, one would be a critical step towards reaching a deal.
This isn't surprising as a successful outcome from bracelet, one together with 92000 thirteen's statistically significant results would give us two randomized data sets demonstrating <unk> ability to drive clinical benefit in HR positive <unk> negative metastatic breast cancer patients.
With <unk>, our King County is one of two pivotal studies required for FDA approval. It would also position us to move rapidly into substantially Derisked registration study and an indication with a large market opportunity in high unmet need.
As we look towards bracelet ones anticipated readout next quarter I should emphasize that we will continue to advance in a deliberate manner as the overall survival as Tom mentioned matures.
With several patients still receiving treatment there is an opportunity for trillium precedent point and.
Good sell ourselves short if we rush into a deal prematurely based on data that could improve over time.
With industry leaders, such as Pfizer Roche, Merck Serono, Bristol Myers Squibb, and insight already familiar with pallet. Thanks to collaborative clinical trials, we intend to run a methodical and competitive process that insurance, we reached the best possible outcome for our shareholders.
Any of the key pieces needed to achieve our BD gold's already in place. Thanks to our current data in breast and pancreatic cancer and.
And we expect that the continued execution of our clinical regulatory strategy will bring us to a successful outcome.
One final note, we continue to advance our preclinical car T program and ongoing discussions with multiple potential Biopharma research partners and maintain constructive conversations on a potential clinical trial.
With that Curt will now review, our fourth quarter and full year financial results Kurt.
Thanks, Andrew.
It's my pleasure to report that <unk> current cash resources have us in a strong financial position with an anticipated runway into 2024 based on our current projections.
This runway is expected to take us past multiple potential value inflection points, including bracelet ones anticipated readout next quarter.
Now moving on to our fourth quarter and year end financial results. We ended 2022 with $32 1 million in cash and cash equivalents in marketable securities compared to $41 3 million in cash and cash equivalents as of December 31 2021.
General and administrative expenses for the fourth quarter of 2022 were $3 7 million.
With $3 8 million for the fourth quarter of 2021.
For the full year 2022, G&A expenses were $11 5 million compared to $13 3 million for the full year 2021.
This change was mainly due to lower investor relations activities.
As with prior quarters in 2022, the global business conditions had negatively impacted market sentiment for the biotech industry and the overall capital markets.
We anticipate this changing in 2023, we limited our IR activities Accordingly in 2022.
Our research and development expenses for the fourth quarter of 2022 were $4 8 million compared to $3 7 million for the fourth quarter of 2021.
For the full year of 2022 research and development expenses were $15 4 million compared.
Compared to $12 9 million for the full year 2021.
The changes from the fourth quarter and full year 2021 to the respective 2022 periods were mainly driven by advanced care Goblet platform study and higher personnel related expenses to support our R&D program.
The net loss for the fourth quarter of 2022 was $8 6 million compared to $7 8 billion in the fourth quarter of 2021, which equates to a net loss of <unk> 14 per share for both periods on a consolidated basis.
And finally, the net loss for the full year 2022 was $24 8 million compared to $26 $3 million in the full year 2021.
Equating to a net loss of <unk> 43 per share for the 2022 period and a net loss of <unk> 49 per share for the 2021 period on a consolidated basis.
I will now hand, the call back to Matt for some closing remarks, Matt.
Thanks, Eric.
First let me extend my gratitude to our clinical trial participants employees partners investigators and shareholders for their contributions towards our progress over the past year.
This progress has brought us to an exciting and crucial points in our corporate evolution.
And our HR positive <unk> negative breast cancer program. The continued advancement of bracelet, one has us close a deal on a critical data readout that if positive will bolster our BD prospects and accelerate <unk> path into a registrational study in this indication.
And alongside bracelet ones, the doubts, but we collaborated with Roche and the <unk> to generate compelling data in pancreatic cancer, providing pillar with the second clear path towards a registrational study.
In addition, our recent data in pancreatic cancer provide a blueprint for how we can efficiently enhance pellet value proposition by adding near term value drivers to our pipeline without taking focus away from its core pillars.
We will continue to follow this blueprint as we move forward as our primary internal focus will be the advancement of our breast and pancreatic cancer programs.
So that we can move into a registrational environment with multiple shots on goal and reduced risk of binary events in.
In parallel we will use collaborative studies to announce pella, an additional highly prevalent indications and the further demonstrate appellate immuno therapeutic mechanism of action positions. It as a platform molecule with expansive therapeutic potential.
With World class collaborators at a talented team that provided that our ability to execute this strategy over the last year. We believe we are well positioned for continued success as we work to improve the lives of cancer patients to pellets development.
With that we'll now open up the call up for Q&A operator.
Ladies and gentlemen, we will now begin the question and answer session.
Follow up question. Please press star followed by the number one.
If you want to withdraw your question. Please press star two.
Your questions will be bolt indoors or they are received.
If you are using a speaker phone please lift the handset before pressing entities.
One moment. Please for your first question.
Your first question comes from John Newman from Canaccord Genuity. Please go ahead.
Hi, guys. Thanks for taking the question.
I was just wondering if you could talk at all about potential.
Design.
So I'm just traveling goblet.
Cancer, just curious I'll stay on the control arm, just sort of what youre thinking about there or just in general terms.
Yeah.
For that study I know that.
Some of the agents that we rely on in other cancers have network as well.
Cancers.
Suitable for control, but just curious if you could talk about that.
Sure, It's Matt and then I'll pass it off to Tom.
Goblet, the pancreatic or arm.
Looked at pillar in combination with Nab, Paclitaxel, Gemcitabine and <unk> and that's where we saw the 70% objective response rate.
The standardized backbone in this population would be fall paradox.
Or Jim Nab Paclitaxel I think the question really comes as do we look at a third arm wherewith added <unk> to the chemo backbone and compare that to you.
That same triplet with the virus added what we've heard from Kols is because checkpoint inhibitors have been so well studied in the context of chemo backbone, whether it be for paradox or Nab paclitaxel.
They really haven't seen in the activity.
With regards to objective response PFS or OS.
So a lot of our collaborators are still it would be unethical to do that without the addition of pillar <unk>.
Or even to run it as a control arm because it's known to be active in it is known to be toxic.
I think we could either just rather simple two arm study.
Jim Nab paclitaxel versus that plus pellet plus the tea leaves about.
We may have shall run we'll call it 15 patients or so.
The checkpoint inhibitor plus for chemo.
Just to show a futility just again to reproduce the fact that it's not active in that it is toxic, but we're hoping to ethics and regulators.
Look at the historical unrealized it's not an active drug combination that allows us not to go forward with that.
Tom do you have anything to add to that.
No not really I agree I think the most straightforward path.
Probably the most valuable to clinicians would be simply to run.
The control arm of Gemcitabine, and Nab Paclitaxel and as Matt alluded to when he designed we would have to discuss with our investigators and the regulators first but I think that would be the path, we would prefer to go down.
It's as simple as some probably the most meaningful.
Okay, great. Thank you.
Thank you.
Also a reminder, showing how our questions. Please first one on one.
Your next question comes from.
George Hill H C Wainwright.
Go ahead.
Thanks, Good morning.
My first question's around bracelet, one I'm just wondering if you can discuss the numerical separation would be looking for on PFS and tumor response and also if you could tell us when you would expect that mature data on overall survival and the data set expected next quarter or the mature data that would help guide the path forward for the program and separately I am wondering if you can.
Minus about that agreement with Pfizer, how does it impact the path forward for breath.
Timing of when Pfizer can decide to move forward with the program or when you decided to seek a different collaboration partner for a potential Registrational program.
Tom I'll, let you take the first part of the question and then I'll ask Andrew to take all of the one regarding the relationship with Pfizer and where we are in that process.
Okay. So the.
<unk>.
I mean, it's impossible to say exactly what numerical difference.
Would consider meaningful but I think we would obviously want a difference that is a clear separation between the arms.
Six months versus $6, two months or something would not move the needle, but a separation that is I think substantial on a proportional level would be very meaningful.
So that's what we would be looking forward.
With regard to the.
And that by the way applies to both the objective response and the PFS because we're looking at both of those endpoints in that in the immediate readout, that's coming along for the overall survival.
Possible to predict.
When that'll be procured mature precisely because patients.
<unk> on how patients do on the study, but I think that it's likely that those data would be available.
In the.
First second third quarter of next year something in that timeframe.
Tom could you maybe speak to how long it takes hold decision making process in terms of looking at phase III, Oh sure, yes sure sorry.
I think that in breast cancer.
Historically, both objective response rate and even more so PFS had been very predictive of the overall.
<unk>.
Successive treatments in PFS as you are probably aware is in and of itself a licensed simple endpoint based on prior experience. So we would view any objective response and PFS.
Data is very impactful and moving forward and would not.
Consider it necessary.
To wait for overall survival data to move on to the next step in that program.
Great and then.
Just as a reminder, just in terms of how you.
The agreement with Pfizer how that impacts.
Central collaboration going forward.
Sure Andrew.
Great.
They had.
Pfizer has a period of.
Review, where they can review the data.
Before it can be shared with anybody else under confidentiality.
That period is over but that doesn't mean that Pfizer and are still looking at the data because the data is still maturing as Tom mentioned.
So we are now outside that that period. So we can.
Under confidentiality agreement.
<unk> also shared the data with other parties Besides project.
Got it and then earlier just discussed having a competitive process for potential collaboration I'm wondering if you could elaborate a little bit more on that level of engagement with these potential partners, especially after the initial goblet data.
In particular interest in breast or pancreatic so could one data set or the other would be more impactful driver of these collaboration discussion.
I think.
Both are are equally critical.
If I had to bet I would say breast is a little more.
More so just because we have a broader.
Body of data, but Pfizer.
The bank data really.
Drove some interest in BD. So we have quite a few companies that are looking at the data across both pancreatic and breast.
And I think it's the fact that you have two shots on goal actually strengthened.
Both your credibility of the data overall, but also.
It allows you to basically drive more interest. So yeah. There are certainly companies that are <unk> in Gi cancers that have more of a bias towards one or the other but I would say anybody who is interested in one is also asking about the other half I've yet to see anybody who just wants to review bank or breast.
Great. Thank you very much.
Thank you there are no.
No further questions at this time you May proceed.
Thanks, Operator, let me conclude by thanking all listening in stressed and how pleased we are with our recent progress as well as our excitement for what lies ahead, we look forward to providing additional updates in the future and wish everyone a great day.
Yes.
Ladies and gentlemen, this concludes your conference call for today, we thank you for participating and ask that you. Please disconnect your lines.
Yes.