Oncolytics Biotech Inc. Q1 2023 Earnings Call
Good morning, and welcome to politics Biotechs first quarter 2023 conference call. All participants are now in listen only mode. There will be a question and answer session. At the end of this call. Please be advised that this call is being recorded at the company's <unk>.
I would now like to turn the call over to John Patten Director of Investor Relations and Communications. Please go ahead.
Thank you operator, and good morning, everyone.
Earlier. This morning, all credits issued a press release, providing recent operational highlights and financial results for the first quarter of 2023, a replay of today's call will be available on the events and presentation section of the architecture 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 company's business prospects.
Development and commercialization of that would be including statements regarding the company's focus.
Objectives, the companys beliefs as to the potential to Baxter TV cause of cancer therapeutics.
Design and anticipated benefits of the company.
Clinical trials anticipated timing there would be some additional data.
Plans expectations regarding potential Registrational studies to be visited I went plans and strategies.
Financial runway and other statements relating to anticipate developments and the company's business.
These statements are based on management's current expectations and lease and are subject to a number of factors which involved.
Delays uncertainties and other factors not under the company's control that may cause.
The results performance or achievements of the company.
Different from the performance.
Expectations implied by these forward looking statements.
Any forward looking statement, which aren't as aggressive expectation or beliefs as to future results.
Expectations or beliefs, especially you can see.
A reasonable basis, but there can be no assurance that these statements of expectation or belief will be achieved.
Factors include results of current opinion clinical trials risks associated with intellectual property protection and enter protection actions by regulatory agencies and those are the factors detailed in the company's filings on SEDAR and the S E C.
It's 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.
Business development, Andrew <unk>, and Chief Financial Officer, Curt Luke.
I'll now turn the call over to Matt to begin managements remarks. Please go ahead Sir.
Thanks, John .
Pleasure to provide an overview of our recent highlights and outlook for the coming months.
Start with the exciting news that came out just last week, when we announced the results from our randomized bracelet, one trial and HR positive <unk> negative.
Static breast cancer will be shared in an oral presentation at the upcoming <unk> annual meeting.
As with one of the world's most well regarded oncology conferences and will provide an excellent venue to discuss our results with potential partners and the broader breast cancer community.
With bracelets <unk> abstract set to be published later this month, we're weeks away from a crucial milestone calibrate alright propeller, there's often refer to it.
As I've mentioned on previous calls the recent one represents pillars last major step on the path to a pivotal study in HR positive <unk> negative metastatic breast cancer.
Key goals for the trial are to inform and design of subsequent licensure, enabling study and to validate prior randomized phase II data that showed pellet driving a statistically significant near doubling of meeting overall survival when combined with Paclitaxel in this indication.
Given embrace whats important to pellet value proposition setting the stage for its upcoming readout will be the primary focus of today's call.
As we look at the bracelet, one upcoming readout and beyond we believe we are well positioned for growth with a pipeline that includes two core pillars.
Namely, our HR positive <unk> negative breast cancer and pancreatic cancer programs.
Both of these programs represent meaningful registration opportunities supported by compelling proof of concept clinical data and FDA fast track designation, we expect to.
Additional guidance on the optimal registration enabling pathways for these programs later this year highlighting just how excited these times are off <unk> with that I will now pass the call off to Tom.
Matt before previewing bracelets upcoming readout, let me first briefly recap our HR positive <unk> negative breast cancer programs current clinical data set to provide context for the trial's goals.
I'll start with an overview of IMT 213, which was a randomized phase II trial that evaluated tele combined with Paclitaxel versus Paclitaxel alone.
Matt mentioned the trial produced statistically significant data.
Showed a near doubling of median overall survival in HR positive <unk> negative metastatic breast cancer patients in the combination therapy group.
These results.
Accorded a subsequent fast track designation from the FDA as well as the special protocol assessment agreement, indicating that <unk> III is a sufficient foundation to allow advancement to a pivotal licensure, enabling study additional data supporting our HR positive <unk> negative breast cancer program.
Phase one results demonstrating pellet single agent activity in this indication as well as results of aware one window of opportunity study that evaluated pellet based treatment combinations and early stage breast cancer patients.
Aware one successfully met its primary endpoint. In addition aware one demonstrated talent immunologic mechanism of action, including its ability to remodel the tumor microenvironment in ways that are associated with improved patient prognosis, such as increased infiltration of T cells into the tumor and improvement in the risk of recurrence.
Sure.
With these prior results, providing a robust foundational data set for HR positive <unk> negative breast cancer program.
The goals of bracelet, one hardest substantiate the positive results of via <unk> and informed the design of a licensure enabling study.
To accomplish these goals, we and our collaborators at Pfizer and Merck <unk> designed bracelet to enroll 48 patients randomized across three cohorts a.
The control arm, consisting of standard of care Paclitaxel monotherapy in.
An arm evaluating paclitaxel combined with Pella and a third arm in which the checkpoint inhibitor of value map was added to Paclitaxel plus pillow.
The first two arms mirror the <unk> III study groups, while the third arm was included to evaluate whether the addition of a value map to Paclitaxel plus pellet.
Provides an additional benefit.
Note that a value may appear as an anti PDL one antibody that was co owned by Pfizer and Merck <unk>. When we designed the study. However today it is solely owned by <unk>.
Note that bracelet, one is not powered to demonstrate statistically significant differences between the treatment groups. Therefore, a successful bracelet one result.
It would be a demonstration that one or both of the pellet containing arms numerically outperformed the paclitaxel monotherapy group. The key endpoints that we are monitoring. The trial include overall response rate and progression free survival.
Another key end point is overall survival. However, these survival results.
More time to mature before they come into focus.
Next I'd like to lay out the sequence of events that will take place around the bracelet, one announcement all of which will be guided by <unk> embargo policy.
On May 25 at five P M Eastern time.
The bracelet, one abstract will be published on the <unk> website, which will allow us to put out a press release detailing the content of the abstract.
So please keep a look out for that press release with the most up to date information.
On Saturday June 3rd breakthrough once oral presentation will be delivered by Dr. Amy Clark during one of the <unk> clinical science symposium.
Following this presentation, we plan to host a key opinion leader webinar on Monday June 5th at eight a M eastern time.
Provide expert perspective on the results and what they mean for HR positive <unk> negative breast cancer programs next steps.
So she didn't join and can find the Webinars registration link on the events and presentation section of our website.
In addition to the oral presentation on bracelet.
<unk> Conference will include a poster on preclinical studies evaluating <unk> potential labeling technology for car T cell therapy in solid tumors.
These studies were conducted in collaboration with Dr. Richard Vials group at the Mayo clinic.
Following the publication of a paper on this topic in science translational medicine last year.
As a reminder, data from the science translational medicine paper showed pellets synergistically enhance the efficacy of car T cells, leading to cures marine solid tumor models.
This was an exciting finding to.
To date car T cells have been unable to effectively treat solid tumors.
Spike the fact that they have revolutionized the treatment of blood based cancers, where long term patient cares have been achieved.
Mechanistic analyses linked the promising results reported in science translational medicine to <unk> ability to overcome the three key challenges that limit the activity of car T cells against solid tumors, namely for self perseverance.
Suppressive tumor microenvironment and antigen escape.
With solid tumors, representing the vast majority of new cancers. These data suggest <unk> may have the potential to substantially expand the addressable population for car T cell therapies collab.
Collaborative studies to build on these results are ongoing and we look forward to sharing additional data at <unk> in the coming weeks.
Lastly, before handing it off to Andrew.
I'll speak briefly about our phase one two goblet trial.
This trial evaluates treatment combinations.
<unk> power plus Roche as a teaser lindsay map and gastrointestinal cancers.
We continue to make encouraging progress and goblet with updates from its advanced anal and metastatic colorectal cancer cohorts expected in the second half of the year in.
In addition, we continue to advance towards key milestones in the trials pancreatic cancer cohort, which forms the foundation of our pipeline second core pillar.
Updated data from this cohort as.
As well as guidance on the program's path towards registration are also expected in the second half of the year.
With that Andrew will now speak about our business development efforts.
Andrew.
Thanks, Tom let me start by reiterating our enthusiasm for pellets core licensing value proposition.
Which stems from our <unk> substantially de risked registration opportunities in breast and pancreatic cancer.
By 2028.
The addressable markets for drug treatable HR positive her two negative breast in first line pancreatic cancer are expected to reach approximately 300, and 135000 patients respectively across the U S major European countries and Japan.
Moreover.
Data from the <unk> 13, and goblet trial provide clinical proof of concept and demonstrate <unk> potential to substantially improve the treatment paradigm in these indications.
With clinical data Derisking, our efforts in large markets with clear unmet needs for improved treatments.
We have been garnering healthy interest in our pursuit of a single licensing deal for our breast and pancreatic cancer programs.
Can't speak to the specifics of ongoing BD conversations at this time.
There are a couple of points that I can make now.
First.
Feedback from our ongoing conversations have indicated that <unk> readout in a few weeks, we'll hopefully kick off a new phase in our BD process.
Given the potential for brands that want to provide a second randomized dataset demonstrating the ability of our pellet paclitaxel combination.
Outperform paclitaxel alone this feedback isn't that surprising.
Second.
Note that even in the event of a successful bracelet one outcome, we don't expect to hastily finalize or announce any deal.
If successful we would have a breast cancer program supported by two randomized dataset, a special protocol assessment agreement, indicating one of two necessary pivotal studies is complete and the fast track designation.
This would put us in an enviable position any negotiation, particularly when paired with our pancreatic cancer program.
Given all of this.
We plan to continue advancing our BD activities with a disciplined methodical approach.
That seeks to drive computation among multiple parties.
Our ongoing past collaborative trials have allowed us to establish formal relationships with many of the leading players in this space, including Pfizer Roche Merck Serono, Bristol Myers, Squibb, and insight, which we believe leaves us well positioned as we seek the best deal possible for our shareholders.
To conclude my section of the call I'll speak briefly about our preclinical car T program.
Building off Toms earlier remarks.
Having been heartened by the positive data from the work we've done with Dr. Rolla, The Mayo clinic.
We are advancing research collaborations with biotech companies interested in validating our recapitulated the results for the science translational medicine publication.
One of these companies has already produced results with Palo <unk> in combination with their own car T contracts that are in line with what was seen previously and Dr. <unk> work that.
That company is not repeating those results to ensure their accuracy and we look forward to reviewing them with our research partner in the second half of the year.
Recapitulated in science translational medicine results is an important step for our collaborator because unlike other agents are classified cannot be assumed that khaki shelf since they behave according to their specific genetic makeup.
We look forward to providing more information on car T work with Mayo at the upcoming <unk> meeting.
With that I'll pass the call off to Kirk for a review of our quarterly financials Kirk.
Thanks, Andrew.
Pleased to report that <unk> remains well financed through bracelet ones readout this quarter.
As well as past the important regulatory updates from our breast and pancreatic cancer programs expected in the second half.
As of March 31, 2023, we had $29 7 million in cash cash equivalents and marketable securities providing us with an anticipated runway into 2024.
This compares to $32 1 million as of December 31, 2022.
Our general and administrative expenses for the first quarter of 'twenty three were $3 2 million compared to $2 6 million for the same period last year.
This increase was primarily due to increased investor relations activities, partly offset by lower share based compensation expenses.
Research and development expenses for the first quarter of 2023 were $3 5 million compared to $3 $7 million for the same period last year.
Decrease was primarily due to lower bracelet, one study costs and share based compensation expenses.
Partly offset by increased manufacturing expenses associated with the process development production runs and higher personnel related expenses.
The net loss for the first quarter of 'twenty, three was $6 4 million compared to $6 8 million in the first quarter of 2022.
This equated to a net loss of <unk> 10 per share for the first quarter of 'twenty, three and <unk> 12 per share for the first quarter of 2022.
So this completes my financial review and brings us to Mats closing remarks, Matt.
Thanks Kurt.
Moving on to the Q&A session I'd like to close with a brief recap of all the exciting milestones we expect to achieve between now and the end of the year.
The first of these milestones will become later this month, when we announced randomized phase two data from bracelet, one and an oral presentation at <unk>, which again is a randomized trial that represents Hello last major step on the path to a registrational study in HR positive <unk> negative breast cancer.
Also at <unk>, we anticipate reporting additional preclinical data on the combination of pillar in car T cells in solid tumors.
In the second half of the year, we expect to provide updated data from our first line pancreatic cancer program and additional guidance on the Registrational pathway for this and our other core programming HR positive <unk> negative breast cancer.
As a reminder, our special protocol assessment agreement indicates that we've already completed one of two pivotal studies needed for approval in HR positive <unk> negative breast cancer, while in pancreatic cancer, we envision a randomized phase <unk> trial with an adaptive design that would allow us to move seamlessly from our phase <unk>.
From analysis to a larger phase III portion that could support a regulatory filing.
Both of these programs are supported by FDA fast track designations, which should aid in our regulatory interactions as we work to confirm the optimal design for our next trials.
Solidifying these designs will further derisk, our programs and expedite our entry into a registration environment with shots on goal in two indications with a large commercial opportunities and long standing unmet needs.
Beyond our core programs, we will continue to follow the blueprint I laid out on our last earnings call to take full advantage of pellets platform potential.
While maintaining focus on our efforts in breast and pancreatic cancer. This blueprint has leverage collaborations with leading players in industry and academia to advance pella, an additional high value indications such as anal colorectal cancer and as an enabling technology for car T cell therapy in solid tumors.
Sticking to this blue trends, we have been able to maintain a capitally efficient approach, while further enhancing <unk> value proposition.
Finally, we expect to provide updates on goblets cohorts evaluating pillar and achieve a little bit about combinations in anal and metastatic colorectal cancer in the second half of the year.
As we work towards our upcoming milestones we are fortunate to have the support of World class collaborators Charles employees dedicated investigators and of course all of our investors.
Each of these individuals as well as our clinical trial participants of an inch.
Rental to pellet developments and the progress we've made towards our mission of improving the lives of patients with cancer.
Like to express my gratitude for all of their contributions and we will now open up the call for questions 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 a sweet home prompt acknowledging your request and if you would like to withdraw from the question queue. Please press star followed by two and if you're using a speaker phone. We do ask that you. Please lift the handset before pressing.
Keith. Please go ahead and press Star one now if you have any questions.
And your first question will be from John Newman of Canaccord. Please go ahead.
Hi, guys. Good morning, Thank you for taking my question.
Just curious if you could give us any color on the potential pivotal design for <unk>.
In breast cancer, and I know that there is.
There's been some.
Studies run in the past with checkpoint inhibitors with various results, but just kind of curious as to how you may or may not work in a checkpoint in a potential pivotal study. Thanks.
Great question, John and to throw another wrinkle in the words I am not sure. If you are.
Read the news that Pfizer turned back of Valium at Merck PGA. So a valley lab is no longer of much interest to Pfizer at this point.
I'll get Andrew to touch on the economics.
If we consider <unk>.
Yeah.
Okay.
Okay.
Hello, Good afternoon Hello.
We lost you there for a second.
Alright.
So <unk>, we showed an overall doubling of survival in HR positive <unk> negative.
Very very heavily pretreated patient population.
All had previous exposure to Taxane bracelet has a paclitaxel versus Paclitaxel power line.
And we're in a much earlier, Bob patient population, who are taxane naive. So we're hoping to see differences PFS or our <unk> and.
And keep that huge sort of delta that we had seen with overall survival, we would like to see improvement with a value mab.
But the reality of it is if we have doubled overall survival.
The increased benefits that the additional $200000 at a value Bob.
It would cause.
Really has to be taken into consideration, we're going to have to see quite a dramatic improvement beyond that one year overall survival to rationalize another $200000. Andrew do you want to talk a little bit about.
What payers have to say.
Yes, their checkpoint inhibitor might come into lifecycle management, and then Tom I'll get you to talk about what we think is the most probable trial design. So Andrew do you want to kick it off.
Sure absolutely. So we actually did some research with European payers.
To see what they would need to see in terms of a survival benefit to cover the product and we chose the Europeans because as you know.
They're much more stringent with coverage decisions than in the U S. So it's kind of.
A higher a harder task master.
And the feedback from them was look three five to four month OS improvement over Paclitaxel.
We'd probably garner their interest in and allow us to discuss contracting in the rest of the coverage process with them.
That was for Palo <unk> plus Paclitaxel is the is the value proposition.
So if you add.
Our value map and you add another we.
We haven't decided where we're going to price ours, but lets say for arguments sake that will price around where the CDK four six we priced by then which with historic price increases would be overdrawn grand per year by time of launch.
And looking at the price increases for checkpoints, let's assume the same as Matt was kind of alluding to.
For our value Bob you are talking about $400000 charge per patient.
To treat.
Youre going to you know.
I haven't spoken to payers, but having been a reimbursement consultant I can tell you, they're going to tell us youre, probably going to have to.
Find the patients that have a doubling of overall survival. So.
That's.
The cost of the additional.
Eight daily as a rate limiting factor that has to be considered.
If we think we can do well.
Clinically and therefore commercially with just Palo <unk> plus paclitaxel. So that's really one of the challenges that we have to think about.
We operate think about lifecycle management, we could always do a separate our smaller trial.
If we choose to not include the checkpoint I'm not saying we are but one thing that could be done is look at that in our lifecycle management to try and find maybe the patients you would have that kind of a response.
And therefore be able to tell to say look for these patients with this profile, we think they'll respond and talk to the payers that way.
Matt anything else from your perspective there.
No I think Thats fantastic I really think.
<unk>.
It becomes a very important figure in lifecycle management I'm not sure it's as important.
For what the phase III it looks like because we really do want to capitalize.
On the 2013 results and then expand those hopefully with very slight into phase III.
Opportunity Tom did you want to talk a little bit about what a study would likely to look like.
Yeah sure, Matt So with the comments of math and Andrew in mind I think the study design will be will be a comparatively straightforward we would envision a two arm study with a paclitaxel control arm and then a paclitaxel plus pellet Ria rep with or without a value mab investigational arm.
And we would then obviously powered appropriately.
Four.
For an overall survival endpoint, and perhaps a PFS and pinpoint depending on how these things.
How things play out, but we but I think the overall design would be pretty straightforward two arm study.
Thank you Tom Okay, great. Thank you.
Yeah.
Next question will be from Louise Chen Cantor Fitzgerald. Please go ahead.
Hi, congratulations on all the progress this quarter and thanks for taking my questions. So I wanted to make sure I heard you right. When you said the bracelet one without power for Stat, Sig and if not what do you want to see to consider this a successful trial or would you expect to be.
Then secondly can you elaborate more on the car key opportunity and what that means for you and last question I had for you is on your cash runway, but positive inflection points does that bring you Sir thank you.
Thanks Luis.
Tom do you want to take the first question, Andrew the second and Kirk the third.
Sure. The first question was.
I'm, sorry say that again please.
So did I hear you right that you deal with Heartbreak for the power, yes, yes. So the <unk> study is a randomized study.
So the patients are randomized between the arms. However, it was not powered to allow a formal statistical comparison, so what we what we will look for.
That study is as criteria for success our.
Numerical differences between the groups.
And the key in the primary endpoint, which is objective response rate as well as any other.
Efficacy endpoints as we mentioned we will be reporting that the progression free survival results, but the overall survival results are not mature enough to report at this time. So we will be looking for numerical differences and then obviously, we can one can conclude based on the magnitude of those.
But keep in mind also that this study.
It is not a standalone study in that it is the first two arms of this study which are the paclitaxel versus the Paclitaxel plus pellet rear rep.
Basically recapitulated, the former <unk> study in which we saw the strong survival benefits. So this is.
I'm, an efficacy perspective will largely be a.
A.
A confirmatory study to provide additional confidence in to Derisk the program further.
Okay.
Andrew.
Opportunity in car T. Andrew do you want to talk a little bit about how we would look at sales and royalty in that particular environment and how across this could potentially work across platforms.
Yes, absolutely Joe.
If you remember from science translational Medicine article.
Each of the mice that had these dramatic responses utilized two doses of <unk>, one that was basically conjugated with the car T and administered to the to the to the mouse.
And then a booster dose afterwards so.
The goal is to open up solid tumors for car Ts because they have struggled to show any efficacy there and so.
Solid tumors are 85% of market. So it's right now running Falco.
But it's about selling car Ts and solid tumors two doses of <unk>.
Are you now.
Dropping the bucket for us compared to the potential in prostate pancreatic cancer. So it's not about selling.
Hello, it's about selling.
$400000 car T in say a liver patient.
But for the power would not be able to be treated with.
With the car T. So the way we see this working.
There would be some kind of an approach.
That would be determined by.
The number of car Ts involved a number of tumor targets involved.
Then there might be some development and regulatory milestones along the way, but the big revenue would be some sort of double digit royalty on the sale of that car T. In every patient.
Palo Europe is added.
The treatment so it could potentially turn into.
A nice revenue.
Stream for us that can be applied to any number of our of our needs.
But it is not our core focus.
Would advise and provide <unk> to the car T developing and then commercializing the combination.
But we don't have any immediate term to get into khaki business ourselves.
Yeah, and then with respect to our cash and cash runway, we reported just under $30 million at the end of the quarter.
We anticipate that that provides a runway of at least 12 months.
A catalyst milestones.
The cash on hand, just gets us through more clearly the <unk>.
Bruce a presentation, we have car T updated <unk> as well in addition, the goblet study.
We are targeting to provide efficacy updates on the pancreatic cancer cohort we're targeting ESMO.
But that's to be determined and the other cohorts the colorectal and anal cancer cohort, we do expect to provide interim updates on those on those other cohorts in the second half of the year.
Our runway takes us through those events.
Thank you.
Thank you next question will be from Patrick to fill up.
Right. Please go ahead.
Thanks, Good morning, just one clarification as it relates to bracelet one in the registration path for HR positive <unk> negative metastatic breast cancer. It sounds like you would need just the one pivotal study to submit for a potential approval, though maybe you can elaborate more on that point, specifically on potential for the accelerated approval pathway.
And how this upcoming <unk> data specifically could facilitate this pathway and secondly can you give us an update on the goblet program, including the expected next date or at least in the second half the timing of this data and what you'd be looking for here to give confidence to advance the program to have a registrational study. Thank you.
Absolutely.
So to start with the goblet.
We've spoken with <unk> and our principal investigator.
Kirk Arnold.
We are starting to see maturity in the pancreatic data. So we will be able to present PFS level you'd likely believe evolving are somewhat mature OS by ESMO Gi Barcelona in October so that's really the timeframe that we're working to.
We're also hoping to provide updates on the other three cohorts likely again within that timeframe, but that's all Gi just because it is such a great showcase for Gi.
Therapy.
Without the right audiences right Kols. So we think that would be very an opportune timing.
<unk> data, we've discussed with stakeholders.
One was so strong we could have expanded that to an additional 30 patients.
But with a 69% objective response rate.
Really we felt that we had demonstrated a very very strong signal on what we wanted to do.
Is moving into a more stringent environment some of what we're talking with.
Corporate partners with Us randomized phase two.
And the 60 patient range.
We're also speaking with cooperative groups that would actually be capable of running a phase <unk> three program.
An adaptive design, where we would our goal I think it's 60 to 80 patients of that purchase television program and if we're seeing let's say bill that we want to see we would just seamlessly move into the phase III. This is very attractive because the cooperative groups.
Provide a lot of expertise and cost of Pearl, but more importantly, they're expeditious they have a preapproved protocols with the FDA. So if we can get through their selection process.
Just a plug and play to get into the phase III environment.
Sorry, Patrick I'm trying to think what was the first part of your question.
Yes, just on the.
On the.
Registrational pathway for.
For HR positive <unk> negative with power and with this bracelet one data just wanted to clarify that you would only need the one pivotal study.
Going forward for potential submission for <unk>.
Regulatory submission for approval I just wanted to.
Make sure that that's that.
That is what is possible.
To the extent that it depends on the <unk> data how does that just how does that facilitate this accelerated pathway.
Well.
Absolutely. That's also another great question.
<unk> showed that doubling of overall survival, we took that to the agency.
And what.
What they told us.
We will provide you with a special protocol assessment for anyone who is listening.
That means that we have agreed to a protocol with the agency.
And they've already because they have granted that the truecar team. The fact, though is one of the two required randomized studies. So we are only one randomized study away, yes people lastly, like they're like why.
Would you then go into your break right and really the question for that was.
2013, we were working under the assumption that this was largely lytic. The result of very strongly indicated that license was probably occurring but the mechanism driving this was really a T cell.
Immediate response to the agency side listening can start that phase III, but youre doing so at some tremendous risk. If you don't fully understand mechanisms of action and if you don't have at least some biomarker plan that measures at T. Cell response that would tell you whether or not those patients are responding. So pfizer was looking at the end of phase two.
Minutes in the SBA and they agree that they could look at it.
One of the things that we can actually look at that we're quite excited about 2018 was a very heavily pretreated patient population I would just remind everyone. We saw about a three week impairment of median PFS, but in that patient population, everyone had already been exposed to our AD sales a taxane.
Bracelets are little bit different is it recapitulate, what we saw in 2014, but it does it in a group of women who are taxane naive. So our hypothesis was if patients have a less.
Damaged or are less challenged immune system, let's keep in mind standard chemotherapies like Taxane really are detrimental to an immune response.
Especially multiple rounds of it our thinking was that we moved to an earlier setting we could actually potentially look at wins in areas like or RM, PFS, where we receive a hint of a signal.
Appreciate it groups. So we thought in a pretreated group that would expand that opportunity now if that's actually the case it's potentially.
Very important in terms of our registration path because a PFS when would get us to a registration program much much earlier than <unk>, because obviously you have to wait for that OS to mature. So what we're hoping is that we see a positive signal in PFS, we could move to dual endpoints for the registration program that would give.
So when that could potentially be as much as 18 months earlier.
Terrific. Thank you so much.
Thanks, Patrick Thank you as a reminder, ladies and gentlemen, if you do have a question. Please press star followed by one on your Touchtone phone and your next question will be from Douglas Ma'am.
RBC capital markets. Please go ahead.
Yes, good morning first question.
If you were to take the OS data from the <unk> three and appliance to the currently ongoing trial when would you expect to start to see maturity of west data in this and bracelet one.
Well.
I'll, let Tom speak to the expectations that the last patient put on study with June 2022, So for PFS. The expectation on the control arm is about a six month median PFS. So we've got all patients out now 12 months beyond that so I would say that that's reasonably well will have mature PFS for <unk>.
So.
OS we're starting to see the events now as I said the study started in 2020. So we've got patients who are on study now for three or four years last patient was more than a year ago, you would anticipate survival here to be about a year or so.
Anticipating we should have a pretty good idea by San Antonio.
What we're looking for Doug is the 80% of the event that might be in early 2024 of them.
Okay, perfect and then.
Just remind me if you're allowed to.
Where patients 48 patients equally divided between the three arms of <unk>.
No. It was 15 on the Paclitaxel 15 on Tac propeller, because we'd already had that.
The agency wanted to see a three patient safety run in so.
<unk>.
<unk> had that three patient run in plus 15, so they have 18.
Perfect. Okay. Thank you.
Good luck.
Thank you and at this time gentlemen, it appears we have no further questions. Please proceed.
Yeah.
Thank you operator, and we wanted to thank everybody who participated this morning.
We're just a few weeks away from being able to disclose what happened and bracelets were obviously very excited.
And we would encourage anyone who can participate and our kols call. The morning of June .
With that I'll say, thanks, again and have a lovely morning, everyone.
Thank you, Sir ladies and gentlemen, this does indeed conclude your conference call for today. Once again. Thank you for attending at this time, we ask that you. Please disconnect your lines have yourself a good weekend.
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