Q3 2022 Zymeworks Inc Earnings Call
[music].
Ladies and gentlemen, thank you for standing by this is the conference operator, welcome to <unk> third quarter 2022 results conference call and webcast.
As a reminder, all participants are in a listen only mode and the conference is being recorded.
After the presentation, there will be an opportunity to ask questions to join the question queue. Please press star one one on your telephone keypad.
I would now like to turn the conference over to Jack Spinks head of Investor Relations at some works.
Please go ahead.
Good afternoon, and welcome everyone. My name is Jack Spinks head of Investor Relations here at them works today, we will discuss our third quarter 2022 financial results as well as provide an update of our ongoing business.
Before we begin I would like to remind you that we will be making a number of forward looking statements. During this call.
Including statements that relate to implementation of our strategic priorities development plans and timing anticipated therapeutic effects and commercial potential of our current and future product candidates.
Expected regulatory interactions anticipated data releases and timing thereof, expected financial performance and future financial position and.
Our ability to execute new collaborations and partnerships and receive milestones from existing arrangements and other information that is not historical information.
Looking statements are based upon our current expectations and various assumptions and are subject to the usual risks and uncertainties associated with companies in our industry and at our stage of development.
For a discussion of these risks and uncertainties. We refer you to our latest SEC filings found on our website and as filed with the SEC.
Later in this call Neil <unk>, our President and Chief operating officer will be discussing our financial results, including certain adjusted non-GAAP measures a description of our adjusted non-GAAP measures and a reconciliation to the most directly comparable financial results as determined in accordance with GAAP are described in detail in our press release.
She is available on our website at www Dot <unk> dot com under the Investor Relations tab.
As a reminder, the audio and slides for this call will also be available on the <unk> website later today.
Now I will turn the call over to Neal, our president and COO, Neil Thanks, Chuck and thank you everyone for joining us today for our third quarter earnings call.
As a reminder, I'd like to note that while I'll be presenting the prepared remarks today, Kenneth Galbraith, our chair and CEO and members of our executive team will be available for Q&A. Following this portion of the call.
With that I'd like to begin today's call with an overview of our financial results followed by a few noteworthy updates on both our clinical and R&D programs as well as an update on our key strategic priorities as laid out in January before we open the lines for Q&A.
This afternoon.
<unk> reported financial results for the quarter ended September 32022.
As reported our revenue for the third quarter of 2022, with $2 6 million compared to $4 $4 million in revenue for the same period of 2021 revenues for the most recent three month period, primarily related to a $2 6 million reimbursement from our partners for research support and other payments.
Research and development expense for the quarter ended September 32022 was $37 1 million compared to $49 9 million for the quarter ended September 32021.
This decrease of $12 8 million from the prior year related primarily to lower employee compensation expenses due to a reduction in head count from our restructuring earlier this year a decrease in manufacturing costs and certain clinical expenses presented data mab due to a roll off of clinical trial expenses related to horizon.
<unk> zero, one as well as a decrease in licensing expenses related to certain preclinical activities.
General and administrative expense for the quarter ended September 32022 was $15 9 million compared to $15 5 million for the quarter ended September 2021.
Excluding stock based compensation and restructuring expenses adjusted general and administrative expense decreased by zero point $1 million for the quarter ended September 32022, compared to the same period in 2021.
This decrease year over year was primarily related to a decrease in professional fees and other expenses in 2022.
<unk> net loss for the quarter ended September 32022 was $47 8 million compared to $60 6 million for the same period in 2021.
Decrease of approximately 20%.
Our cash resources, consisting of cash cash equivalents and short term investments.
$166 2 million as of September 32022.
This cash burn of $75 million in the third quarter was higher than the prior quarter due to quarter to quarter timing differences in cash flows largely driven by payments made in the third quarter of $11 million related to process performance qualification activities.
$4 million related to clinical development and additional timing related cash outflows associated with insurance renewals special projects and other miscellaneous corporate items.
Based on our current operating plan and assuming the receipt of upfront payments from jazz licensing agreement before the end of this year.
We believe our cash resources will fund planned operations through at least 2026.
As we noted on our recent conference call. Following the announcement of the licensing agreement with jazz.
The transaction with jazz has the potential to transform our financial position by the end of 2022, and it's extremely important to our ability to deliver upon our key strategic priorities through 2023 and beyond.
In addition, we continue to be active in evaluating the monetization of legacy financial and preclinical assets as well as seeking new and expanded partnerships licenses and collaborations across our product candidate portfolio as a core piece of our strategy for development and commercialization.
Given the transformative nature of the licensing agreement with jazz, we expect to be able to provide a summary of our key milestones for 2023, along with further financial guidance for 2023 early next year. After the expected closing of the agreement and receipt of upfront payments by the end of 2022.
For additional details on our quarterly results and for a description of our non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financials.
Encourage you to review our earnings release, and other SEC filings as available on our website at Www Dot <unk> Dot com.
For those who missed our call in October I would like to take a few moments to provide a quick update on our recent licensing agreement to.
To start I want to note that we were extremely excited to sign and announce our exclusive licensing agreement with jazz pharmaceuticals for Zander data, Matt during the quarter.
This licensing and collaboration agreement provides jazz with the global commercial and development rights to Zander data Mab, excluding those territories already governed by our Asia Pacific partnership with Beijing.
Our agreement with jazz provides significant potential economic value for <unk> and its stockholders and fulfills a major strategic objective that we identified and communicated in January of completing our global partnering transaction for Zander data map within this calendar year.
The agreement with jazz was the culmination of a broad business development process evaluating a range of potential commercialization options presented data Mab, which we completed with the assistance of our external advisors on the transaction.
<unk> Health partners.
We strongly believe jazz has the right company to help deliver this important her two targeted by specific antibody based therapeutics to patients globally.
Jazz is a leading global biopharmaceutical company that brings a wealth of development and commercial experience in oncology.
We expect that this transaction will enable <unk> to leverage jazz as existing integrated capabilities and global infrastructure to commercialize efficiently and will be complementary to Beijing strength in there Asia Pacific region.
Notably in the U S. There's a significant overlap with jazz as existing zelle could call universe, where they have built strong relationships and quickly established <unk> as the standard of care in second line small cell lung cancer.
Under the terms of disagreement zenimax would receive $375 million in upfront payments in two separate tranches, which we anticipate will be received before the end of 2022.
The tranches consist of a $50 million upfront payment subject to antitrust clearance under the U S. Hart, Scott Rodino Act and the second payment of $325 million at Jazzes option. Upon the readout of the topline clinical data from Horizon BTC Zero, one study which is currently.
Expected before the end of 2022 and.
In addition, we are eligible to receive up to $525 million in regulatory approval milestones.
A further $862 5 million in milestones are available to <unk> upon the achievement of specified commercial milestones.
<unk> is also entitled to receive tiered royalties between 10% and 20% of net sales of standard data mab pending approval.
<unk> will also be reimbursed for 100% of costs associated with ongoing Zander data map related clinical studies with jazz to fund, 100% of future clinical development costs for studies not already in progress.
While we in jazz will establish and maintain various joint committees to coordinate future activities such as development.
Manufacturing and regulatory affairs.
Under the terms of the agreement <unk> will continue to oversee clinical studies that are ongoing today through their completion.
Additionally, in partnership with jazz <unk> will submit the first BLA presented data Mab and we'll partner with jazz on future regulatory filings.
This involvement is critical as we continue advancing our ongoing clinical studies of <unk> towards regulatory filing and hopefully approval, allowing our employees to finish what they started many years ago with the goal on day, one of striving to improve patient outcomes over the current standards of care and a variety.
City of her two expressing tumor indications.
While the ongoing pivotal studies Zander data Mab and BTC and GE will be the initial focus of the collaboration Zimmer and jazz expect to continue evaluating clinical data from ongoing phase one and two clinical trials hosanna data mab for indications beyond BTC and gea.
As we wait for HSR clearance. Our teams are diligently planning post close integration and gathering information for integration planning purposes.
To be very clear, we and jazz are excited about the potential for the broad applicability of Zander data map across a range of her two expressing cancers beyond gea and BTC.
Including both metastatic breast cancer, and colorectal cancer, where we have ongoing clinical studies and potentially future indications Rosanna data map may be able to provide benefits to patients and difficult to treat cancers.
The initiation of any new clinical studies presented data mab will be communicated publicly as and when appropriate and we look forward to working with jazz on continuing to maximize the global benefit to patients and stakeholders by optimizing zander data maps development.
Our announcement with jazz represents the culmination of years of work by the <unk> team.
And Moreover, we believe that patients around the world will benefit from this agreement.
By securing funding and capabilities from our partners jazz and Beijing Zanna data Mab is now positioned to advance into the potentially broadest group of patients as possible who find themselves in need of novel her to targeted therapies and who seek improved outcomes beyond the current standard of care.
We look forward to providing additional updates on the completion of this transaction before the end of 2022.
As a reminder, I encourage you to listen to our earlier webcast and to view the slides available on our Investor Relations website, which highlight the benefits of this transaction as they are critical to our go forward strategy.
I'll now spend a moment speaking to our early research and development programs before I turn back to our clinical programs.
With the expected proceeds from our recently announced licensing agreement with jazz, we intend to accelerate development of our preclinical product candidates into clinical studies with the goal of five new <unk> in the next five years.
And with the first two of those <unk> still expected in 2024.
While we recognize that recently the focus has been on our her two clinical programs. Our early R&D day on October 20th highlighted our potential to build a clinical stage oncology product portfolio of Adcs and multi specific antibodies that go beyond her too.
We expect to continue to present additional details and to update the progress of our preclinical programs the scientific and medical meetings throughout 2023.
Also as previously mentioned, we are continuing to engage in discussions to broaden our early R&D efforts through partnerships and collaborations.
<unk> core expertise in antibody engineering, and ADC chemistry led to the development of our technology platforms and ultimately to our clinical programs that have been in the spotlight in recent years.
We have continued to hone and refine this expertise and the same platforms, which resulted in <unk> <unk> and host a platform licensing and development agreements that remain active across the pharmaceutical industry.
This expertise remains the foundation of our development of novel Biologics and future clinical candidates and gives us the confidence that <unk> will continue to be a leader in both the multi specific antibody therapeutic and antibody drug conjugate modalities as we move forward beyond Zander data manner.
Our clinical candidates presented at our R&D day, which includes three <unk> based antibody drug conjugates developed using our novel Topoisomerase payload ADC platform and multi specific two plus one format T cell engaging antibody developed using our asymmetric multi specific platts.
<unk>.
The result of the continued effort and focus we bring to developing novel multifunctional targeted therapies for difficult to treat cancers with a focus on diseases with the lowest five year overall survival rates and where our advanced biologics may be able to make progress towards significantly improved outcome.
For patients.
While we expect that the anticipated near term proceeds from our collaboration with jazz provide us with the funding for the development of a number of product candidates over a reasonable timeframe. We continue to seek partnerships and collaborations both regionally and globally as an integrated part of our R&D strategy to both broaden.
And accelerate our product pipeline and to maintain our leading position of our technology platforms.
Looking forward, we expect to have numerous opportunities for the presentation of additional clinical data over the coming months.
On December 9th at the San Antonio Breast cancer Symposium, we will present initial data from our ongoing study in later line. Her two positive hormone receptor positive breast cancer patients treated with <unk> in combination with full vestron and Pablo cyclic Pfizer's CDK four six <unk>.
EBITA marketed as <unk> brands.
Moreover, I am happy to announce that enrollment of the targeted 50 patients. In this study was recently completed several months ahead of schedule.
Additionally, later this year, we plan to present data in a manuscript accepted for publication detailing the results from our phase one dose escalation and expansion study of Zanna data mab as monotherapy in patients with locally advanced and metastatic or two expressing or amplified cancers.
These data will provide additional patient follow up from data previously presented at ESMO Asia in 2019 and will include more than 80 patients with various hurt you expressing cancers, including biliary tract cancer salivary gland cancer, non small cell lung cancer <unk>.
Harry cancer endometrial cancer and other her two expressing cancers.
Furthermore, and importantly, we remain excited and on schedule to report top line data in 2022 from our Horizon BTC zero, one phase III pivotal clinical trial of <unk> monotherapy for the treatment of metastatic or advanced her two amplified biliary tract.
Cancer.
With this timeline, we would expect to present comprehensive clinical data from the horizon BTC zero one trial in a major medical meeting in the first half of 2023.
The outcome of this pivotal study may provide the support for initial global regulatory filings presented data map in conjunction with our partners jazz and Beijing.
Additionally, we are continuing to make progress in recruiting and following patient in our multicenter Global Phase III Open label first line study of <unk> plus standard first line combination chemotherapy regimens and select Gi cancers, including Gea Bt's.
<unk> in colorectal cancer.
The GE cohort originally reported in September 2021 at ESMO.
Continues to follow the fully enrolled patient population and we hope to be able to present additional clinical data based on longer term follow up at a major medical meeting in the first half of 2023.
We also recently began another zander data map investigator initiated trial, which will evaluate the safety and efficacy of Santa data Mab in combination with Tesla lithium mab as a chemotherapy free treatment regimen for patients with her two positive advanced gastric and gastroesophageal junction cancer.
Who have progressed on current standard of care.
This study is being conducted by Dr. Sun Young raw and Doctor means Q June at the young say cancer Center in South Korea, and the results of this study may provide a valuable opportunity to understand the potential for a chemotherapy free zanna data map combination regimen to improve outcomes.
<unk> for this patient population.
As a reminder, we also have another investigator initiated phase two single arm open label pilot trial evaluating <unk> in patients with early stage her two new positive breast cancer sponsored by MD Anderson.
These investigator initiated trials provide valuable insight into zander data <unk> effectiveness and a diverse subset of patient populations and remain important and continuing to define zander data maps breath of effectiveness across various her two positive indications lines of therapies and drug combinations.
We also had the opportunity at last quarter's ESMO meeting to present initial promising data for our second clinical candidate and first antibody drug conjugate Zanna data Mab dotan or <unk> 49 for short.
Bypass topic hurt you targeted antibody drug conjugate.
We presented encouraging preliminary results from a basket study of her two expressing cancers in 77 patients representing the first published clinical results since the IND.
In 2018.
Specifically in 2009 response Evaluable patients dosed at two five milligrams per kilogram every three weeks.
Then the datum ebbs over dotan exhibited a confirmed objective response rate of 31% in a heavily pretreated patient population across multiple her two expressing indications.
Importantly, these data provide a characterization of the Tolerability profile Rosanna data <unk> dotan with a manageable side effect profile in relation to other her two targeted ADC approved or in development.
The most commonly reported adverse event keratitis was predominantly grade one or two in severity and shown to be reversible.
Remember that no changes or discontinuation and dosing was required for grade one events for.
Great two keratitis further dosing of <unk> is held until symptoms and clinical findings of keratitis improve to grade one or complete resolution.
And then the dosing has resumed at a reduced dose of two milligrams per kilogram.
The phase one study remains ongoing including our cohort of patients on a weekly regiment of Zanna data map, which I'm happy to report is now fully enrolled.
We're still awaiting the full dataset from our Q weekly cohorts to determine a recommended phase II dose, which we expect to be able to report over the next few months.
Presentation of additional phase one clinical data presented data <unk> dotan as expected at a major medical meeting in 2023.
In addition to having a differentiated tolerability profile to other her two adcs.
<unk> has not shown any overlapping toxicities with standard of care agents used in the treatment of cancer, including cytotoxic chemotherapy and we have the ability to develop <unk> dotan as either a monotherapy or in combination with a variety of other agents.
This flexibility is important and we believe that allows for the potential differentiation of Zander data <unk> in early lines of therapy, or an ADC may be particularly useful to treat difficult to treat cancers in specific indications.
Furthermore, the immunogenetics cell death mechanism of action scene with Zander data maps overdose may provide an opportunity to combine with Io agents in particular PD one inhibitors.
Our planned approach in development will be to look at indications, where we can combine with standard of care chemotherapy that is used in early lines of treatment.
As we discussed recently, we intend to explore the potential of Zander data maps overdose in the treatment of non small cell lung cancer, which has three distinct subpopulations that can be targeted.
Her two amplified.
Two expressing and her two mutant.
Given the PD one inhibitors are actively use a standard of care in non small cell lung cancer patients. We plan to evaluate this dual approach with zander data Mab overdose.
We also would like to further explore the single agent activity seen with Zander data <unk> in other tumor indications such as colorectal ovarian endometrial and bladder cancers, either as a monotherapy or in combination with current standard of care.
Further we are interested in studying <unk>.
In her two positive metastatic breast cancer patients who have progressed on prior treatment with Trastuzumab direct city can.
And the data presented at ESMO, we had one patient with a best response or stable disease to prior treatment with Trastuzumab <unk> T can who showed a durable response to zanna data maps overdose after progressing on PD XD.
We are also interested in studying <unk>.
In the rapidly evolving hurt you low breast cancer population.
As we have done every quarter. So far this year I think it's important to note. The significant progress we have made in 2022 towards the completion often ahead of guidance of our key strategic priorities that were laid out in January .
With the release of our initial results from our phase one trial presented data <unk>. The completion of our re domicile to Delaware the announcement of our licensing agreement for Zanna data man and the unveiling of our pipeline assets at our early research and development day, we've had a busy and exciting past few months, where we have made grew.
Strides towards implementing and achieving our key strategic priorities.
These goals were put in place to provide a measured and systematic approach towards what we believe to be the best way to generate long term stockholder value.
I'm very proud of the work that our employees have made since January .
However, the year is not over and we still have an exciting couple of months ahead of us.
We have additional data catalysts presented data mab, including the presentation of results from our late line. Her two positive hormone receptor positive metastatic or advanced breast cancer study of Zander data Mab in combination with full veteran and Palomar cyclic as well as topline data from our phase III pivotal study horizon.
BTC zero one.
Further we anticipate receiving payments under our collaboration agreement with jazz totaling $50 million upon the receipt of Hart, Scott Rodino clearance and an additional $325 million of jazz elects to continue the collaboration following the delivery of topline pivotal results.
All of which is expected to occur before the end of this year.
These major events behind US 2023 will be a continuation of the plan laid out in.
In January .
With a transformed financial position multiple additional zanna data related clinical data catalysts further delineation of the path forward for <unk> Dotan continued development of our preclinical pipeline.
And an aggressive partnership and collaboration strategy, we anticipate 2023 will bring with it continued progress and key developments across the company.
As <unk>, President and Chief operating officer, and having been with the team since 2007 I am extremely excited about our accomplishments this year and the path ahead for the company.
2022 has provided challenges across the biotech sector.
But I am confident that with our recently announced agreement with jazz.
<unk> incredible momentum in our clinical programs and across our newly unveiled early R&D pipeline and recent steps like our successful re domicile to Delaware, we stand poised to capitalize on the opportunities ahead of us.
None of this would be possible without the tireless dedication of our team.
On a daily basis I continue to be impressed and made proud by the quality and magnitude of work done by our team.
After undergoing a restructuring in January our employees, whether they'd be scientifically technically clinically our business focused have all worked incredibly hard day in and day out to build a strong foundation and to secure our future path from which to grow our successful biotech company.
With a more focused strategy and a nimble team we've done more with less and we will continue to take this approach with our lean disciplined and data driven approach to future growth.
To all of those who have been with us through what has been a challenging year for everybody investing and working in biotech Zion works now looks forward to the future from a strong financial and scientific flooding.
And we expect to continue delivering upon these results generating long term value for our shareholders and ultimately improving the lives of patients by generating antibody based therapeutics with the potential to dramatically improve on the current standards of care and difficult to treat cancers.
With that I'd like to thank everyone for listening to our prepared remarks, and I'll turn the call over to the operator to begin the question and answer session.
Operator.
Okay.
Thank you.
Ladies and gentlemen.
Join the question queue, you May press Star one one on your telephone keypad.
Youre using a speakerphone please pick up your handset before pressing any keys.
Awesome moment as callers join the queue.
And our first question coming from the line of Stephen Willey with Stifel. Your line is open.
Yes. Good afternoon, thanks for taking the questions and congrats on the progress so Neil maybe just.
Clarify it now sounds like Youre guiding to.
Receiving I guess both of the jazz payments before the end of this year.
I think it's maybe a little bit different than what the prior guide was with respect to getting the 50 and then.
Likely securing the $3 25 tranche in the event that they opt in.
In early 'twenty three so is that a byproduct of just.
Your ability to kind of pull together.
The BTC data and to get that communicated in a more.
In a more timely fashion.
Yes, Steve It's Ken Galbraith is while I can I can take that question.
I think our guidance is consistent with.
What we provided when we announced the jazz partnership I'm, sorry, if that wasn't that wasn't clear.
So we have every expectation to believe that the Hart Scott Rodino process.
Can be cleared this year and.
We do believe that we will be able to provide the topline data from the BTC study this year to enable jazz to opt in in such a time frame that both of those payments will be received.
For December 31st this year, and that's always been our guidance sorry, if that was.
Not clear from before.
Yes, sure that's a mistake on my part.
And then just with respect to the San Antonio presentation.
I know clinical trials Dot Gov, I think had a target enrollment of 86 you guys are saying 50 is the difference there just a function of accelerated dose escalation.
Just kind of curious as to the disconnect between those numbers and then are there any notable differences just between that study and the monarch study that was previously conducted looking at.
Looking at her set in.
<unk>. Thanks.
Ill, let Dr. Joseph can answer both of those yes, hi, this is Neil Josephson.
Yes.
Our assessment about the the.
Study numbers is right.
We always put in the number of patients that there has to be dose modifications as part of the dose finding.
A part of the study so thats why the number was higher it was always meant to have 50 patients in the in the Evaluable population of at the at the dose level that was that was deemed safe.
And then your question about the monarch study so so the monarch study.
Was a three arm study this is a one arm study.
The the essential.
The feature of the moniker study in terms of what was evaluating the combination of different CDK four six <unk> or <unk>.
<unk> and <unk>.
Combination with.
Trastuzumab and.
And therefore that trend so.
We are using a different so this has a different.
CDK <unk> inhibitor.
And it has a different.
<unk>.
Our two targeted agent, obviously, you're kind of at that amount.
The patient population in general is similar I would say that that the patient population that we're treating is more heavily pretreated than the.
What we're seeing in the moniker studying mainly because of <unk>.
The.
<unk> ability of.
Additional targeted agents.
So those are the similarities and the differences between between the studies.
Great. Thanks for taking the questions.
Sure.
Thank you one moment for our next question.
And our next question coming from the line of Charles <unk> with Guggenheim. Your line is now open.
Hey, good evening everyone.
Congrats on the progress and thanks for taking my questions. Maybe first one on the <unk> 49. It sounds like you guys are really progressing forward or at least have.
We made a lot of progress on the Q weekly dosing schedule.
How should we think about the positioning of Q weekly relative to the Q3 weekly that you guys had recently presented at ESMO and how should we also think about potential pushes and pulls between.
<unk> for versus possibly or potentially improved correlate to clinical profile, both as a single agent and as well as with combination partners that could have varying infusion schedules. Thank you.
Hi, This is Joseph.
Yeah. So.
A couple of points one is that that.
The data that we presented at ESMO.
<unk> focused on the on the Q3 week dosing schedule and as we said then.
And we.
Uh huh.
The activity and Tolerability profile of the Q3 week dosing regimen was.
Something that we we felt hit hit the go criteria for us to take forward.
But when you still had more weekly on patients.
That needed to be we needed to let that weekly dosing.
Data Pan out to see if if if.
That was a preferred schedule.
So we haven't made any public announcements about about what will be what we would be going forward with.
We will be going forward with one of the two dosing regimens.
That your point about weighing convenience versus.
The the activity and safety.
Our profile.
The different dosing regimen is an important one we're very well aware of the fact that a Q3 week dosing schedule from the standpoint of patient convenience as much.
<unk> two to implement and so.
From that standpoint.
Not looking for something to be just the same or even maybe perhaps even marginally better.
We want to see something that's significantly better to go.
Forward with the key weekly, but we havent completely.
Sure.
<unk> analyzed all the data and we haven't made an announcement yet about that.
We're taking forward and I don't know if you had another question that I missed.
I think that largely covers that question.
<unk>.
Yeah, and maybe just one more from me, perhaps regarding the CW <unk> 49, and I know you guys have spoken about this before but.
How should we think about the potential value you could potentially extract hypothetical partnership is a function of additional in house data that you may generate then where return on investment might be the great greatest Brazilian works. Thank you.
Yes, I can take that I think.
I think you saw at ESMO, we have an agent that we feel has sufficient single agent activity to move forward, we think that well characterized the tolerability profile of the agent.
And it's excellent when you stack up against all of the other her two ADC in.
In development I think we've thought very thoughtfully and carefully about.
Indications, where it's going to be 49 in combination with other agents, whether they'd be PD, one or a chemotherapy standard of care could provide.
Encouraging.
Efficacy.
And tolerable.
Safety profile and so we'd like to go forward and generate some additional data.
In those indications of interest I think we've laid out a pretty clear.
List of development fees that we have.
And I think as we've stated before our goal would be to to move.
<unk> 49 provided it continues to show the encouraging data that we've seen so far into a registration pathway by 2025.
And at the same time to seek some kind of partnership before moving into registration studies.
It could be.
U S.
And nature to allow us to retain an opportunity for our future commercialization opportunity for maybe four nine in the U S.
And so I think we have a well thought out investment strategy around the molecule. We think additional clinical investment is justified from the return on investment that we've targeted inside the company.
And we're going to move forward and execute at a very rapid.
Incomplete and high quality development program and continue to share that data with potential partners as we move towards that registration pathway by 2025, and we think we.
We think I.
I think.
I think people underestimate I think the value of.
Data map and a potential partnership opportunity, even though around investors and analysts.
And I think we've showed that we can do good work with agents that we've designed and developed ourselves.
And that we have the ability to strike what I think are good.
This development partnerships to allow us to continue development.
And commercialization and I think with VW 49, we're looking forward to two.
Conducting the right development going forward and at the right time, hopefully enter into a business development partnership for that but allows us to.
To move forward.
Opportunity to see the encouraging data was going to be 49 that we've seen so far.
Got it great. Thanks for taking the questions.
Thanks, Rob.
Thank you one moment please for our next question.
And our next question coming from the line of <unk>.
I'll now come off <unk> with Citi. Your line is open.
Tim This is Oscar Mubarak on for Yigal, Thanks for taking my questions.
Just going back to the to the timeline updates related to SaaS deal.
It sounds like Josh will be required to make an opt in decision based on your timelines this calendar year.
But they'll have to potentially pay to $325 million before year end and I'm just wondering when the reimbursement portion of that Mike might kick in will that also be before year end reserve some timeline of 2023.
No provided provided jazz opts into the partnership than the R&D reimbursement.
From the date that we signed the agreement back which was back on October 19.
We haven't tried to quantify that it's kind of reimbursement in Q4, but obviously when we.
We report our results for 2022 in the event that jazz ops, and then you'll be able to see the benefits of that in there.
The reduction of our cash burn rate in Q4.
Okay, Okay, great that makes sense.
Maybe going back to the CD four CDK four six combo data you'll be sharing.
Later this year.
Can you maybe give us a sense of what your view is compelling for the combo versus.
Historical standards.
So this is Neil Josephson.
I would say that.
As I pointed out are really heavily pre.
Pre treated patient population.
That debt.
Generally doesn't have a lot of good options.
So what we're looking at is a chemo free regimen that has.
That's well tolerated.
<unk> has activity.
And.
And that gives us.
A durability of responses and so I think that I don't want to get ahead of myself and start talking about what data is going to be presented at <unk>.
SAP Dcs, but those are all the things that we were that we were looking at and.
You'll be able to evaluate.
How this regimen.
Forms in this in this population and is one of the other questions that.
Asked before about Monica I.
I think that this is.
A similar patient population, but even more heavily pretreated.
And so so if you arent.
Get a sense of how.
Of what.
A good result would be based on looking at what.
You would expect for standard of care therapy in that in that.
Late line, which would be chemo plus <unk>.
Okay, great. Thanks for taking my questions.
Thank you one moment please for our next question.
And our next question coming from the line of Gena Wang with Barclays. Your line is now open.
Hey, thanks for taking our questions.
So far the Jess do you I know there were a lot of questions being asked around the criteria to exercise that option after the BTC pivotal readout.
Thinking that BTC is a relatively small market.
A proportion of economics would likely be from the.
The rest of the portfolio.
Just wondering is there anything you would like to highlight in terms of read through from BTC pivotal data to the rest of indication.
Breast cancer.
<unk> might be interesting.
No good question again.
The structure of the arrangement in jazz and the opt in with.
It was around allowing them to see the data from our pivotal data readout that was going to occur pretty soon after signing the agreements.
So I think that was a pretty reasonable crossed and we found a way to have a pretty clear and quick process for that to occur.
And as you state there, there's obviously value in.
Potential lines detonator Mab from.
The BTC indication that GE indication and future indications.
Which I'm sure you guys have their own.
Iterations and termination of value on each.
We did.
So I can't really comment more more on that I think.
PTC pillar data that's coming up is really exciting for us. This is our first.
Opportunities for our clinical data readout, there could be a part of our future regulatory filing.
So we're very excited about <unk>.
The indications for BCC patients as you know with this patient population.
Considerable unmet need, especially in in her to targeted therapy piece of it we're going to data that could be the first <unk> targeted therapy for this patient population and also being given in a chemotherapy free regimen, which is extremely important.
So I think we're really excited about the readout itself with this pivotal data and look forward to having the topline data reporting that reporting the full data at a major medical meeting in the first half and then obviously going forward with consultations with regulatory agencies in the U S and around the world on the pathway to make this accessible to us.
The patients.
Beyond that we've been working as you know on a number of other clinical studies both in our pivotal study with <unk> in first line <unk> in combination with chemo and also the arm with chemo and Beijing PD, one and we've also been continuing to enroll.
In a number of breast cancer patients, we continue to enroll in our phase III first line GE.
Many of them have been chemotherapy, which we'll report out additional data in the first half of next year and we also enroll enroll right now in our phase III first line BTC study with that data amount plus Genesis.
Which we continued to accrue patients in.
So I think we're really excited about the BTC readout itself.
Exciting time for for us to be a biomarker.
And I think we think it's another part in.
All the data we've been able to generate to show the potential broad applicability of that data mab.
In multiple her two expressing tumors.
And I may have another one how much reduction in R&D expenses would you expect from the reimbursement.
For the full amount has been a very substantial.
Part of our cost structure, including in 2022, where we're running two pivotal studies and a very significant CMC campaign to prepare for the first.
BLA filings.
And obviously with the structure of the agreement on the elevated amount with jazz.
That cash burn will.
Fall two jobs in terms of reimbursement and all the work we're doing on ongoing studies and then funding themselves any new studies related to is that a data mab.
We're not going to provide any guidance at this point the thing after completion of the deal by the end of this year, which we expect will provide some financial guidance as well as key goals for 2023 early in January and you'll just have to wait for that guidance to get a good understanding of how our cost structure and cash runway will will change during 2023.
Other than our previous guidance that we do expect our cash runway to last through at least 2026 with the completion of this deal.
Got it thank you Youre welcome.
Thank you one moment. Please next question.
And our next question coming from the line of Jameson with Wells Fargo. Your line is open.
Hi, guys. Thanks for taking my question.
I was going through the presentation today, and I noticed that the jazz milestone payments based on Danny's PTC and GE indications or any milestones related to her to breath and we'll be breath expenses reimbursed by Jack and then I have a follow up.
Yes with respect to the second part of your question so any ongoing clinical studies.
That we had underway as of October 19, we will continue managing those and we are obliged keenan managing those and jazz we'll fund those so obviously that includes not just <unk>, but beyond.
That which we're undertaking in breast cancer and colorectal cancer.
So all of those studies will be will continue to be ongoing to their conclusion and funded by jazz.
New studies, which we decided to go forward with what we funded 100% by jazz and managed by them.
As you'll note in the deal we have.
$525 million in regulatory approval milestones.
Which we have not.
<unk> identified what indications of what geographies those should relate to obviously with PTC and GE being very advanced in both in pivotal studies.
It's a safe assumption that that a considerable amount of those regulatory milestones would apply to indications that we've taken much further along.
But there are also regulatory approval milestones, therefore indications beyond PTC and GE.
So I think you should expect that one talks about with US is clear and we can then start to work jointly with jazz to make some of these decisions about.
New indications that will make public statements of the right time about additional studies that will be undertaken was done to date amount beyond the ones that are currently ongoing.
Thanks, Ken.
Then for Danny steps yet David.
Really appreciate the color on the 50 patients.
I'm not sure how much can say, but can you give us a ballpark on how much follow up will have and whether we'll be able to assess a stable.
Yes, again, I don't really want to get into the specific specifics of the data presentation.
<unk>.
The.
Can say that that what we are presenting at sbcs is an interim data cut it will have.
You'll be able to see some patients who been followed for quite a period of time.
But there'll be others that will have just recently come on study. So it's not a final data cut it's an interim data cut and.
There will be some patients that you can look at and get an idea.
Of.
Some durability.
Ability based on the fact that they have been followed for a long time, but others are going to be just on for short period of time. So.
You have to take the interim data cut and realize that that it doesn't give you the full picture, but I think you'll be able to see some of what youre getting at.
Thank you that's it from my end.
Thank you our next question now.
And our next question coming from the line of.
<unk> <unk> with Jefferies. Your line is open.
Hi, This is Andy I'll correct harsh thanks for taking our question. So we have to make.
So the first one is on <unk>.
101 will notice.
No.
No one showed better antitumor activity in preclinical stage.
<unk> <unk> why do you think that's the case could we think due to the difference in potency with it.
<unk> versus <unk>.
Additionally, a merck showed some initial response.
Media.
Alright, thats very helpful levels, but that tumor reduction in fact now with tank. So do you have confidence that the efficacy we have seen.
<unk> one <unk>.
Great that's very often need exceptional levels could be sustained and also my second question is on brining Philips GE can you give us an update I'll following timelines in the U S and also ex U S.
Can you file for accelerated approval and what type of data we need to include into our impact. Thank you.
Thanks for the question I'll just take the second one and then I'll see how much Dr. Palmer, who wants to answer of the multipart first question, but with respect to gea. The only guidance. We've provided so far is to complete the enrollment in our pivotal study by the end of 2023, we've made no guidance with respect to the filing timelines.
The nature of the study is as.
It has been published.
So I think as Youre aware, if we're able to recruit the patients by the end of 2023.
Then there will be a PFS and interim OS readout likely sometime in 2024 and depending upon that data that will give us the ability to.
Consult with regulatory agencies about an approved accelerated approval pathway.
And the fall OS readout them would be approximately one year later in 2025, which will give us another opportunity.
For a potential full approval.
In certain regulatory authorities. So we haven't provided any guidance about that and we won't until we have the opportunity obviously to see the data and likely make some regulatory consultation, but I think the <unk>.
<unk> for both accelerated approval and full approval will discuss broadly on a global basis with regulatory agencies like we're pretty clear on that and right now we're just focused on <unk>.
Recruiting a high quality study on time.
And then looking at the data and deciding what the next step is with us in conjunction with regulatory agencies, and our partners Beijing and jazz and I'll, let Paul decide.
The first question.
Thanks, Ken This is Paul Moore.
Yes, thanks for the question.
I think something that we've tried to communicate at the R&D day was our strategy to the design of our Adcs is really to think about.
The totality of the molecule so the antibody.
The payloads the linker.
And the features of all the molecule and so when we develop that we spent a lot of time actually selecting the antibody itself.
<unk>.
Really good internalization, so that that's a key feature that we think is there.
Important feature of the molecule.
And then of course, what we've designed in here is that we have we have the choice of different payloads.
We've got our own proprietary <unk>, but in this case, we've decided to work with the total <unk>.
It would.
<unk> also differentiates us from.
A multiple that you mentioned the immunogen molecule so.
From an efficacy standpoint, we've been very pleased with what we've seen from the efficacy and you mentioned that we see that so far in the many different tumor types.
Current levels of folate receptor, we feel we can we can work in the.
Medium expressing folate receptor.
Tumors.
And then.
From the other component of that is the Tolerability and the selection of the dollar we felt we could go to the dark and then based on the safety profile that we saw.
Nicole.
Non clinical studies, so that complete package, we feel it gives us a very great opportunity to have a best in class molecule.
Got it thanks.
Thank you there appear to be no further questions I'd like to turn the conference back over to Simon for closing remarks.
Well that's great. Thank you operator, and thanks, everyone for spending some time with us and for your questions.
As you are aware, we've had a pretty exciting few months.
At <unk> on many different levels and I'm. So pleased that our hard work has allowed us to be able to achieve many of the key milestones that I laid out hopefully very clearly on January 15th.
I took over as CEO .
And for US 2022 is not done yet we have a number of data announcements coming out at <unk> in San Antonio and then we're very much looking forward to reporting our top line data from our BTC study before the end of 2022, and then look forward to discussing with you in early January of 2023 and talk clearly.
About our key goals and milestones for 2023 and provide some financial guidance given the fact that our financial position.
As expected to be transformed by the opt in of jazz and.
And our partnership after the BTC data is delivered to them. So we're really excited about the position of the company right now and how hard we work to put ourselves in this position and we're very excited about the next couple of months in 2022 and very much looking forward to having continued performance.
With our team during 2023 and look forward very much to the laying that out for you in early January next year. So thank you very much and have a nice day.
Ladies and gentlemen. This concludes today's conference call. You may disconnect. Your lines. Thank you for participating and have a pleasant day.
The conference will begin shortly to raise your hand during Q&A you can dial one one.
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