Q1 2022 Zymeworks Inc Earnings Call

Yes.

Good day and thank you for standing by.

Good day, and thank you for standing by welcome to design works.

Welcome to the Zymeworks First Quarter 2022 Results Conference.

For 2022 results conference call.

At this time, all participants are in a listen-only mode.

So, as I said earlier, you know, beyond the written statement we made last week, you know, we can't comment further on any aspect of the discussions and hopefully the clarity I had, is straightforward.

At this time all participants are in a listen only mode.

After the speaker's presentation, there will be a question and answer session. To ask a question, you will need to press star 1 on your telephone. In addition, if you require any assistance, please press star 0.

After the speaker's presentation, there will be a question and answer session to ask a question you will need to press star one on your telephone. In addition, if you require any assistance. Please press star zero and now it's my pleasure to hand, the conference over to your first speaker today, Jack Spinks head of Investor Relations. Thank you. Please go ahead.

And now, it is my pleasure to hand the conference over to your first speaker today, Jack.

I think once we have something to talk about, then we will, when it's appropriate and required.

Head of Investor Relations.

So I think we'll just have to be patient on that.

Good afternoon.

And welcome everyone. My name is Jack Spinks Associate director of Investor Relations here at <unk> today, we will discuss our first quarter 2022 financial results as well as provide an update to our ongoing business.

Thank you.

I can't comment to the partnering and collaboration discussions before I got here as CEO.

Please go ahead.

All I can say is that, you know, as the new CEO who started in mid-January, I was very clear with all the folks we had talked to and new folks about our openness to considering a multitude of different structures and our desire to partner and collaborate much more than we had before in building this company from early stage to late stage.

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 the implementation of our strategic priorities clinical development of our product candidates related clinical trials anticipated clinical data presentations potential therapeutic effects savanna data map and our other product candidates.

I think that's really clearly understood by a lot of potential pharmaceutical partners out there.

You know, they all have my mobile phone number.

They know I'll always pick it up if there's any interest.

Good afternoon and welcome, everyone.

So I don't think we need to worry about our openness to engage with them.

<unk> expected financial performance and future financial position.

My name is Jack Spinks, Associate Director of Investor Relations here at Zymeworks.

Obviously, we have engaged some of them previously under CDA with prior data sets.

Commercial potential of technology platforms and product candidates anticipated continued receipt of revenue from existing and future partners our preclinical pipeline.

We are able to interact with them now under confidentiality agreements and share data in advance of the peer review setting that you discussed.

Anticipated sufficiency of cash resources and other potential sources of cash to fund our planned operations into the second half of 2023 and potentially beyond.

And that would apply for DW-49 as well.

Our ability to execute new collaborations and partnerships and other information that is not historical information.

Forward 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.

For a discussion of these risks and uncertainties you refer you to our latest SEC filings is found on our website and as filed with the SEC.

Today, we will discuss our first quarter 2022 financial results, as well as provide an update to our ongoing business.

So I don't think there's anything that folks that we're in discussion with will need to wait for ASCO to have the ability to get more real-time data under confidentiality and restrictions that you would understand.

Later in this call Neil <unk>, our Chief operating officer will be discussing our financial results, including certain non-GAAP measures.

Descriptions of our 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, which is available on our website at www Dot <unk> dot com under the Investor Relations tab.

As a reminder, the audio and slides from this call will be available on the <unk> website later today with.

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 the implementation of our strategic priorities, clinical development of our product candidates, related clinical trials, anticipated clinical data presentations, potential therapeutic effects of Xanadatamab and our other product candidates, expected financial performance and future financial position, the commercial potential of technology platforms and product candidates, anticipated continued receipt of revenue from existing and future partners, our preclinical pipeline, anticipated sufficiency of cash resources and other potential sources of cash to fund our planned operations into the second half of 2023 and potentially beyond.

With that I will turn the call over to Neil.

Neil.

So I think we're very open to engage.

Thanks, Jack and Hello, everyone.

Our ability to execute new collaborations and partnerships and other information that is not historical information.

We're very open to structures around partnerships and collaborations as long as they work for building value for our investors.

You for joining us today for our first quarter earnings call.

And I think those discussions are active and busy.

I would like to start today's call with a note on our recently received unsolicited non binding proposal from all Blue Falcons.

And as soon as we have the right partner for the right program and the right pricing structure that works for our investors, then we will conclude that deal and announcement.

As we mentioned in our press release issued on April 28 2022.

The <unk> board of directors, we will carefully review the proposal to determine the course of action that it believes is in the best interest of the company and all of <unk> shareholders.

And I don't think anybody in that process is waiting for additional data sets that might come out of peer review meetings.

I would also like to remind everyone listening that this was an unsolicited non binding proposal and as such no formal offer has been made by ABF.

Thanks a lot.

If a formal offer is made it will be reviewed by the board and its advisors.

And a formal recommendation by the board will be made to shareholders in due course.

And your last question about the cost, we haven't given guidance around that.

While we recognize there may be further questions on this matter, we will not be able to comment beyond what we have publicly disclosed in our previously issued press release.

Forward-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.

So we obviously know where our cash runway is.

For the remainder of the call today, we very much look forward to discussing our business and operations as we continue to work towards our corporate goal of building shareholder value by enabling patients to return home to their loved ones disease free.

For discussion of these risks and uncertainties, we refer you to our latest SEC filings as found on our website and as filed with the SEC.

We obviously know what we can afford to do on our own versus things that might only be possible for us to start being partner dependent.

With that I will continue with the discussion of our financial results followed by an update on our clinical and preclinical activities and general corporate updates.

Later in this call, Neil Klafus, our Chief Operating Officer, will be discussing our financial results, including certain non-GAAP measures. A description of our 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, which is available on our website at www.zymeworks.com, under the Investor Relations tab.

As a reminder, I'd like to note that while I'll be presenting the prepared remarks today, our entire executive team will be available for Q&A. Following this portion of the call.

As a reminder, the audio and slides from this call will be available on the Zymeworks website later today.

So I think as we give guidance about the next clinical steps for Zannie and ZW49, we will clearly address how we're going to fund that.

With that I'd like to jump right into an overview of our financial results followed by an update on our clinical and R&D programs, followed by a few closing remarks before we open up the lines for Q&A.

With that, I will turn the call over to Neil.

Your next question is from David Martins with Bloom Burton, please go ahead.

This afternoon <unk> reported financial results for the quarter ended March 31 2022.

Neil?

Good afternoon.

As reported our revenue for the first quarter of 2022 was $1 9 million compared to zero point $6 million in revenue for the same period of 2021.

Thanks, Jack.

My first question is a follow-up to an earlier question on the first-line breast study that's coming up.

Revenues for the three month periods were primarily related to research support and other payments from our partners, which often include cost sharing arrangements.

You mentioned that you're benchmarking combination data, combination regimens with existing HER2-targeted drugs.

Research and development expense for the quarter ended March 31, 2022 was $62 5 million compared to $44 3 million for the quarter ended March 31 2021.

You know, I think in particular Cleopatra is a good one to look at, but how do you view the potential for in HER2 to change the first-line hurdle and standard of care, and what does that mean for ZANI going forward?

Dr. Neil J.

These increases from the prior year related primarily to higher clinical trial expenses presented data met due to the initiation of the horizon <unk> zero one study.

Sure.

You know, so Inhertu is obviously in a frontline study and has the opportunity to change standard of care in that setting if it's a positive study from the standpoint of efficacy and safety.

I would say that, you know, trastuzumab and pertuzumab are really well-established therapies and will still be well-established therapies regardless of the readout of the frontline study with Inhertu.

So from that standpoint, I can't predict the future to say what exactly we are, you know, our data will look like versus theoretical data from this study that's ongoing now.

But I can say that when we look at the early-line landscape, that we know that both Inhertu and both trastuzumab and the combination of trastuzumab and pertuzumab with a taxane are going to be...are going to have a home in early-line therapy.

And so when we think about our approach to developing xanadatumab in breast cancer, we're thinking of it along the lines of how a combination agent...

Okay.

And a corresponding increase in the associated drug manufacturing expenses.

And then my second question, it is about the offer, but it's mainly asking for a clarification.

Additionally, the company incurred severance and other expenses due to its restructuring program.

You know, you emphasize that it was unsolicited and non-binding.

And I'm wondering if that means to you that you don't need to engage with All Blue Falcons until they make a formal offer, or is it something... Am I interpreting that wrong?

Like, it is something that you should be engaging with.

No, I think the comment I mentioned before was clear.

These increases over the prior year were partly offset by lower clinical trial expense for <unk> to be $49.

General and administrative expense for the quarter ended March 31, 2022 was $12 1 million compared to $1 3 million for the quarter ended March 31 2021.

General and administrative expense for the quarter ended March 31, 2022 included noncash stock based compensation recovery of $5 1 million comprised of $2 $2 million expense from the equity classified awards and a $2 9 million recovery related to the noncash mark to.

Market revaluation of certain historical liability classified awards at $3 9 million from restructuring expenses.

Excluding stock based compensation and restructuring expenses general and administrative expense increased by $3 2 million for the quarter ended March 31, 2022 compared to the same period in 2021 on an adjusted non-GAAP basis.

The increase year over year was primarily related to severance and other expenses incurred due to the company's restructuring program in 2022 as well as a nonrecurring sales tax refund recognized in 2021, which offset expenses in the prior year.

<unk> net loss for the quarter ended March 31, 2022 was $72 7 million compared to $44 6 million for the same period in 2021.

The increase in net loss was primarily due to increases in research and development expenses and general and administrative expense in 2022 as compared to 2021 as we previously noted.

However, it is worth highlighting that the increased operating expenses in this quarter driving net loss are expected to trend lower in upcoming quarters relative to current levels.

Based on our forecasted operating expenses and largely driven by the ramp down of clinical expenses due to the completion of enrollment in our horizon BTC zero one study.

And exiting the startup phase of our horizon <unk> one study in combination with a reduction in manufacturing expenses driven by the completion of a significant portion of our process performance qualification runs.

We believe there will be a reduction in operating expenses throughout the remainder of 2022 and into 2023 based on the spending prioritization restructuring and nonrecurring spending related to future BLA filings I spoke to above.

Our cash resources, consisting of cash cash equivalents and short term investments were $305 million as of March 31 2022.

Based on our current operating plan and in combination with proceeds from certain existing collaboration payments, we anticipate receiving.

We believe our cash resources will fund our planned operations into the second half of 2023 and potentially beyond.

In addition, we continue to make good progress towards our previously announced goal of executing on new partnerships and collaborations in order to potentially increase this runway beyond 2023 via non dilutive capital.

Okay.

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 I encourage you to review our earnings release and other SEC filings as available on our website at Www Dot <unk> Dot com.

I also want to provide a brief update on the restructuring efforts we announced in January .

As described on our last earnings call by March one we had exceeded our previously announced workforce reduction of at least 25%, which we had guided as being completed by the end of this year.

The reduction and realignment of our workforce included 50% of the senior management team and in January we noted that we would be initiating a search for a new head of global research and development.

To that end I wanted to note that the search for a new chief scientific officer, or CSO is progressing well and I look forward to providing more information over the course of the year.

Additionally.

Behalf of the entire leadership team and our board of directors.

Wanted to thank our outgoing senior Vice President of regulatory Affairs, Dr. Bruce Hart as he leaves the company to pursue new opportunities.

I know I speak for everyone on the regulatory affairs team and across the organization as we wish him well in his future endeavors.

In parallel with the ongoing progress made in the selection of a new CSO. We are actively advancing targeted hires across the organization aligned with the transformation of our workforce. We will continue to update the market with further details as they arise.

I mean, we got a letter.

With that.

And hello, everyone.

I would like to move onto a clinical update for our two lead programs.

Thank you for joining us today for our first quarter earnings call.

All we know is what was in the letter and the security fine.

As announced last week I'm very excited to highlight that ahead of our published guidance of mid year 2022, we together with our partner Beijing have recently completed enrollment in the horizon BTC zero, one study our pivotal trial evaluating <unk> as monotherapy in patients with <unk>.

I would like to start today's call with a note on our recently received, unsolicited, non-binding proposal from All Blue Falcons.

That's all we know.

As we mentioned in our press release issued on April 28, 2022, the Zymwerks Board of Directors will carefully review the proposal to determine the course of action that it believes is in the best interest of the company and all Zymwerks shareholders.

We did put a written statement out last week saying that we had received it and we were studying it appropriately, which I think you understand we would, as I said, you know, with real seriousness as we do everything with urgency, you know, professionalism and the interest of all shareholders there.

I would also like to remind everyone listening that this was an unsolicited and non-binding proposal and as such, no formal offer has been made by ABS.

You know, what we specifically decide to do next publicly or in private discussions, we'll do that and then we'll make a public statement when it's appropriate and necessary.

If a formal offer is made, it will be reviewed by the board and its advisors. And a formal recommendation by the board will be made to shareholders in due course.

While we recognize there may be further questions on this matter, we will not be able to comment beyond what we have publicly disclosed in our previously issued press release.

I don't think we'll talk about the next steps until we've made a determination what those are.

For the remainder of the call today, we very much look forward to discussing our business and operations as we continue to work towards our corporate goal of building shareholder value by enabling patients to return home to their loved ones disease-free.

With that, I will continue with the discussion of our financial results, followed by an update on our clinical and preclinical activities, and general corporate updates.

So I shouldn't read into that positioning one way or the other, I guess, wait, wait and see what happens.

Yeah, I think, you know, you can choose, I'm sure others will read into a lot about this, but I, you know, sincerely, I think we made a written statement last week, which I think was pretty clear.

As a reminder, I'd like to note that while I'll be presenting the prepared remarks today, our entire executive team will be available for Q&A following this portion of the call.

Okay, thanks.

I think the comments I've made today are very clear that to the extent that we need to make a public statement about something, we'll do it as appropriate and necessary after the work that we need to do internally to do that.

With that, I'd like to jump right into an overview of our financial results, followed by an update on our clinical and R&D programs, followed by a few closing remarks before we open up the lines for Q&A.

But to the extent that we have private discussions with the group that sent us the letter, or other third parties we may have discussions with, we'll keep those discussions private until such time as it's necessary and appropriate to make any of those discussions public.

This afternoon, Zymeworks reported financial results for the quarter ended March 31st, 2022. As reported, our revenue for the first quarter of 2022 was $1.9 million, compared to $0.6 million in revenue for the same period of 2021. Revenues for the three-month periods were primarily related to research support and other payments from our partners, which often include cost-sharing arrangements.

That's it for me.

Research and development expense for the quarter ended March 31, 2022, was $62.5 million compared to $44.3 million for the quarter ended March 31, 2021. These increases from the prior year related primarily to higher clinical trial expenses for ZanaDataMap due to the initiation of the Horizon GEA-01 study, and a corresponding increase in the associated drug manufacturing expense.

Thank you, David.

Additionally, the company incurred severance and other expenses due to its restructuring program.

Previously treated her two amplified biliary tract cancer or BTC.

These increases over the prior year were partly offset by lower clinical trial expense for ZW40.

General and administrative expense for the quarter ended March 31, 2022 was $12.1 million compared to $1.3 million for the quarter ended March 31, 2021. General and administrative expense for the quarter ended March 31, 2022, included non-cash stock-based compensation recovery of $5.1 million, comprised of $2.2 million expense from the equity classified awards, and a $2.9 million recovery related to the non-cash mark-to-market revaluation of certain historical liability classified awards, and $3.9 million from restructuring expense, excluding stock-based compensation and restructuring expenses.

Based on our forecasted operating expenses, and largely driven by the ramp down of clinical expenses due to the completion of enrollment in our Horizon BTC01 study, and exiting the startup phase of our Horizon GEA01 study, in combination with a reduction in manufacturing expenses driven by the completion of a significant portion of our process performance qualification runs, We believe there will be a reduction in operating expenses throughout the remainder of 2022 and into 2023 based on the spending prioritization, restructuring, and non-recurring spending related to future BLA filings I spoke to above.

Your next question is from Jenna Wang with Barclays Police, go ahead.

General and administrative expense increased by $3.2 million for the quarter ended March 31, 2022, compared to the same period in 2021 on an adjusted non-GAAP basis. The increase year over year was primarily related to severance and other expenses incurred due to the company's restructuring program in 2022, as well as a non-recurring sales tax refund recognized in 2021, which offset expenses in the prior year.

Our cash resources consisting of cash, cash equivalents, and short-term investments were $300.5 million as of March 31, 2022. Based on our current operating plan and in combination with proceeds from certain existing collaboration payments we anticipate receiving, We believe our cash resources will fund our planned operations into the second half of 2023 and potentially beyond. In addition, we continue to make good progress towards our previously announced goal of executing on new partnerships and collaborations in order to potentially increase this runway beyond 2023 via a non-dilutive cap.

Zymeworks net loss for the quarter ended March 31, 2022, was $72.7 million, compared to $44.6 million for the same period in 2021. The increase in net loss was primarily due to increases in research and development expenses and general and administrative expense in 2022 as compared to 2021, as we previously noted. However, it is worth highlighting that the increased operating expenses in this quarter driving net loss are expected to trend lower in upcoming quarters relative to current levels.

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, I encourage you to review our earnings release and other SEC filings as available on our website at www.zymwerks.com.

I also want to provide a brief update on the restructuring efforts we announced in January. As described on our last earnings call, by March 1st, we had exceeded our previously announced workforce reduction of at least 25%, which we had guided as being completed by the end of this year. The reduction and realignment of our workforce included 50% of the senior management team.

To that end, I wanted to note that the search for our new Chief Scientific Officer, or CSO, is progressing well, and I look forward to providing more information over the course of the year.

Hi, good afternoon.

PTC is a hard to treat cancer.

And in January, we noted that we would be initiating a search for a new head of global research and development.

This is Hershida on for Gina.

And advanced or metastatic cases are associated with a poor prognosis.

Thank you for taking our questions.

Globally, approximately 210000 patients are diagnosed with BTC each year.

With her to being expressed in between 5% to 20% of BTC cases.

And they are being currently no approved her to targeted therapies for this indication.

<unk> stands to potentially help many patients around the globe.

<unk> is committed to developing new therapies for hard to treat cancers like advanced or metastatic hurt you amplified BTC.

And completing our enrollment in our first pivotal study is a major milestone and a testament to the hard work and dedication of our outstanding team and the clinical sites and investigators that we are privileged to work with on this study.

With the last patient enrolled in a primary endpoint of objective response rate, we are updating our guidance with regard to the horizon BTC zero one study timeline.

We expect to lock the study database by the end of the year and share results by early 2023.

Additionally, on behalf of the entire leadership team and our Board of Directors.

Additionally, we expect the full details of this study to be presented at a major medical meeting in 2023.

I want to thank our outgoing Senior Vice President of Regulatory Affairs, Dr. Bruce Hart, as he leaves the company to pursue new opportunities.

I know I speak for everyone on the Regulatory Affairs team and across the organization as we wish him well in his future endeavors.

In parallel with the ongoing progress made in the selection of a new CSO, we are actively advancing targeted hires across the organization.

Aligned with the transformation of our workforce, we will continue to update the market with further details as they arise.

With that.

It is worth reiterating that the FDA has granted xenon data map breakthrough therapy designation for patients with previously treated her two gene amplified biliary tract cancer.

I would like to move on to a clinical update for our two lead programs.

As announced last week, I'm very excited to highlight that ahead of our published guidance of mid-year 2022, we, together with our partner Bayesian, have recently completed enrollment in the Horizon BTC01 study, our pivotal trial evaluating Xanadatumab as monotherapy in patients with previously treated HER2-amplified biliary tract cancer, or BTC. BTC is a hard-to-treat cancer, and advanced or metastatic cases are associated with a poor prognosis.

Globally, approximately 210,000 patients are diagnosed with BTC each year, with her two being expressed in between 5% to 20% of BTC cases.

And there being currently no approved HER2-targeted therapies for this indication.

As such Zanna data map is eligible for accelerated approval priority review and Rolling review by the FDA at such time that a BLA is submitted.

Xanadatamab stands to potentially help many patients around the globe.

Zymeworks is committed to developing new therapies for hard-to-treat cancers like advanced or metastatic HER2-amplified BTC. And completing our enrollment in our first pivotal study is a major milestone and a testament to the hard work and dedication of our outstanding team and the clinical sites and investigators that we are privileged to work with on this study.

With the last patient enrolled and a primary endpoint of objective response rate, we are updating our guidance with regard to the Horizon BTC01 study timeline. We expect to lock the study database by the end of the year and share results by early 2020. Additionally, we expect the full details of this study to be presented at a major medical meeting in 2023.

It is worth reiterating that the FDA has granted Xanadatamab breakthrough therapy designation for patients with previously treated HER2 gene-amplified biliary tract cancer. As such, Xanadatamab is eligible for accelerated approval, priority review, and rolling review by the FDA at such time that a BLA is submitted.

In addition, our partner Beijing recently received breakthrough therapy designation for <unk> for the center for drug evaluation of China's National Medical products administration for treating patients with BTC, who have failed prior systemic therapies.

In addition, our partner Beijing recently received breakthrough therapy designation for Xanadatumab for the Center for Drug Evaluation of China's National Medical Products Administration for treating patients with BTC who have failed prior systemic therapy.

As soon as the pivotal data is available.

And our partner Peking expect to have discussions with various regulatory agencies to inform our next steps.

As soon as the pivotal data is available, we, and our partner Beijing, expect to have discussions with various regulatory agencies to inform our next steps, at the upcoming meeting of the American Society of Oncology, or ASCO.

I know this was touched upon before, but for the data updates at ASCO, I know you provided guidance on, or you know, additional color on patient numbers and follow-up, but I was curious, are you able to provide any benchmarks on what we should see in terms of response rates at the ASCO updates for both GEA and breast cancer?

At the upcoming meeting of the American society of oncology or <unk> or.

Our Asia-Pacific partner, Beijing, will present two studies with Xanadatamab used in the first-line setting. The first presentation, scheduled for June 4, highlights phase 1b2 data of Xanadatamab in combination with the K-POX regimen of chemotherapy and the PD-1 inhibitor Tizololizumab for first-line treatment of HER2-positive advanced or metastatic gastric and gastroesophageal junction adenocarcinoma or GEA. This is the first clinical data presentation of Xanadatamab in combination with chemotherapy and a PD-1 inhibitor.

Dr. Neil Jay, do you want to answer that question if you can?

Our Asia Pacific partner, Beijing will present, two studies with <unk> used in the first line settings.

I'm, Yeah, I am.

The first presentation scheduled for June four highlights phase one b two data of Zander data math in combination with the <unk> regimen of chemotherapy.

You know, in terms of benchmarks, I think that, you know, if you want to think about benchmarks for, you know, what to think about in terms of, you know, breast cancer, and we all know the Cleopatra response rates in the first line.

We know that the TOGA and, you know, the TOGA and JAKOB response rates and PFS in gastric cancer, I mean, I think that, you know, those are the, you know, areas that we're going in to with these Phase II studies, and so, you know, the data, you know, that we would be interested in comparing to, and, you know, there's lots of caveats about cross-study comparisons, but when you're thinking about, you know, what do we need to do to become standard of care, you have to look at those as the benchmarks to which you would aspire to.

And the PD one inhibitor <unk> for first line treatment of her two positive advanced or metastatic gastric and gastroesophageal junction adenocarcinoma or gea.

And your final question is from Robert Burns with HC Wainwright.

This is the first clinical data presentation of Zanna data mab in combination with chemotherapy and a PD one inhibitor.

Please go ahead.

And this regimen is currently being studied in one of the treatment arms of the ongoing Phase III Horizon GEA-01 study. The data in first-line HER2-positive GEA complements the interim phase two results with Xanadatamab and the standard of care chemotherapy in the same indication that was presented at the European Society for Medical Oncology annual congress in September of last year. The data presented at ASMO showed a confirmed objective response rate of 75%, a median duration of response of 16.4 months, and a median progression-free survival of 12 months, and exhibited a manageable safety profile in 28 response-evaluable patients.

Hi.

And this regimen is currently being studied in one of the treatment arms of the ongoing phase III horizon.

This is Mitchell.

Thank you for taking our questions.

Zero one study.

The first one I just wanted to ask, again, on the ASCA data, if you could describe what more we could see qualitatively from the abstract to the presentation.

The data in first line her two positive gea complements the interim phase two results with Zander data map and the standard of care chemotherapy in the same indication that was presented at the European Society for medical oncology annual Congress in September of last year.

I'm not going to take that.

Yeah, I think that there's a little bit longer follow-up in the gastric cohort and in the breast cohort, but there'll obviously be a much more detailed presentation of data in terms of showing depth of response and duration, at least what we can show at an interim cut in terms of patients that are still on and how long they've been on and continuing to respond.

So you'll get that color, which you can't really get from an abstract, and like I said, there'll be a little bit later data.

Okay, great.

Thank you.

The data presented at ESMO showed a confirmed objective response rate of 75% a median duration of response of $16 four months and a median progression free survival of 12 months and exhibited a manageable safety profile in 'twenty eight response evaluable patients.

And yeah.

And sorry, just to add, you know, we will be scheduling an investor webcast at the end of our second presentation, and so that we were able to talk about other aspects of Danny's clinical development, plans beyond the data you might see in the abstracts and the presentations as well as answer questions.

That may arise from that, so we're hoping to have a more fulsome presentation beyond the two specific data sets that are available and answer questions about any broadly.

The second presentation at ASCO is scheduled for June 6th, where our partner Beijing will present preliminary phase 1B2 data for Xanadatamab in combination with doxotaxel for the first-line treatment of patients with HER2-positive metastatic breast cancer.

Great, thank you.

The second presentation at <unk> is scheduled for June six where our partner Beijing will present preliminary phase one b two data presented data map in combination with docs are taxable for first line treatment of patients with her two positive metastatic breast cancer.

And when thinking about your appetite for business development opportunities, how do you consider and have you considered, you know, what is a critical mass?

Yeah, I think, you know, I think it's a little before, I think the one thing that I did want to take a little bit of a change at Zymeworks was to try and find a way to integrate partners and collaborations throughout the program, as I mentioned, because it, you know, it can allow us to go more quickly. It can allow us to do things beyond what we currently can do.

It'll improve the commercial competitiveness as we go.

And I think it's a way to leverage, you know, our shareholder capital with partner capital. And I think there's a way to do that, that builds long-term value, doesn't give up upside, doesn't take away the possibility of future M&A from those partners or existing partners or new parties.

So I think it's a way to do that.

Well, I've done that before.

And I think, you know, if you look at, you know, use Aichi Sankyo and AZ as an example, where I don't think it was necessary entirely for Aichi Sankyo to need anyone for and her two other other ADCs that were developing, but I think the AstraZeneca investment was a way to bring in a partner, give up some economics around the program, but obviously, as you've seen, be able to build a much broader clinical program, more in parallel, more timely, and improve the commercial competitiveness for them beyond what they could have done themselves.

It is important to note that this will be the first data presented for Xanadatamab in a first-line setting for advanced or metastatic HER2-positive breast cancer.

So I think we're, you know, in a similar line.

It is important to note that this will be the first data presented for Zander data map in a first line setting for advanced or metastatic <unk> positive breast cancer.

I'm thinking that there, you know, we're running two clinical studies with Beijing as a partner, but mostly on our own, and we're able to do that.

And if we do that successfully, I think there's many things we can do on our own that will work out well in the early stage preclinical pipeline.

But it's an opportunity to integrate partnerships in the manner that I said, that can build a long-term value to our own investors, as opposed to just the partners' investors, in accelerating timing, breadth of programs, competitiveness, then I think we can do that in such a way that it'll build value and won't take away from future M&A value or ability to grow the business around those partnerships, how we integrate a series of those things throughout the product portfolio, what structure we take with each individual partnership, which will probably be different, depending on how we engage and who we engage and what the product line is. I think we can do that in such a way that we'll be a stronger company, I think more attractive for future value growth.

As a reminder, in December, we presented data on Zanadatomab in a late-line breast cancer setting where Zanadatomab plus chemotherapy demonstrated encouraging anti-tumor activity in heavily pre-treated patients with HER2-positive breast cancer. The data presented for 22 efficacy-evaluable patients resulted in a confirmed overall objective response rate of 36.4% and a median progression-free survival of 7.3 months, and the combination of Xanadatamab and chemotherapy was well tolerated with a manageable safety profile.

And I think we'll be able to develop more products more quickly and improve our competitiveness so we can get more market share once we get approval for these agents.

As a reminder, in December we presented data on Zander data map and a late line breast cancer, setting, where zanna data map plus chemotherapy demonstrated encouraging anti tumor activity.

So, I think once we get the first one, you know, complete and announced, we can talk about the rationale for it, why we did it the way, why it fits the messaging I just gave you, and then how it might impact what to think about as the next one beyond that.

So, the timing and structure and scope of these, you know, will, you know, could change over time depending upon, you know, what the first one looks like and maybe the second one and go beyond that.

So, as we unravel, you know, as we unroll this strategy with specific transactions, we can talk more about how this is online with the strategy I just played out.

Hope that's helpful.

Heavily pretreated patients with her two positive breast cancer.

Great.

The data presented for 'twenty two efficacy evaluable patients resulted in a confirmed overall objective response rate of 36, 4% and a median progression free survival of seven three months and.

Absolutely.

And the combination of Zanna data map and chemotherapy was well tolerated with a manageable safety profile.

We look forward to building upon these results in a setting where we believe XanaDataMap exhibits characteristics that are well-suited for these early lines of therapy.

And looking forward to it.

We look forward to building upon these results in a setting where we believe zander data map exhibit characteristics that are well suited for these early lines of therapy.

Thanks so much.

The third abstract submitted to ASCO contained interim data on late-line hormone receptor-positive HER2-positive breast cancer patients treated with Xanadatamab in combination with Fulvestrin and Pfizer's Ibrant. The abstract was selected for publication only, however, we subsequently withdrew the abstract from the meeting.

And that concludes the question and answer session.

The third abstract submitted to <unk> contained interim data on late line hormone receptor positive her two positive breast cancer patients treated with <unk> in combination with <unk> and Pfizer's <unk>.

I will now hand the conference over to Ken Galbraith for any closing.

That's great.

I really appreciate your attention and questions today to the business design work.

The abstract was selected for publication only however, we subsequently withdrew the abstract from the meeting.

To ensure this promising regimen is appropriately recognized and presented to clinicians and the public, we will continue to let this data mature in the patient population evaluation.

To ensure this promising regimen is appropriately recognize and presented to clinicians and the public we will continue to let this data mature and the patient population evaluated.

As such, we plan to submit an abstract containing a larger data cut to a major medical conference in the fourth quarter of this year.

As such we plan to submit an abstract containing a larger data cut to a major medical conference in the fourth quarter of this year.

Currently, more than 50% of late-line HER2-positive breast cancer patients are also hormone receptor positive, which represents a substantial addressable patient population.

Currently more than 50% of late line her two positive breast cancer patients are also hormone receptor positive.

Which represents a substantial addressable patient population and we look forward to presenting a more mature data cut pending abstract acceptance at a conference later this year.

And we look forward to presenting a more mature data cut pending abstract acceptance at a conference later this year.

In addition to the milestones on Xanadatamab, we continue to make progress in the development of ZW49, our second clinical candidate and first antibody drug candidate utilizing our XymeLink platform technology with an orostatin-based payload. During the first quarter, we complete enrollment of 30 patients in the Q3 weekly expansion cohorts at 2.5 mg per kg.

In addition to the milestones on Santa data, Matt We continue to make progress in the development of VW 49, our second clinical candidate and first antibody drug candidate utilizing our <unk> platform technology with an oral statin based payload.

During the first quarter, we completed enrollment of 30 patients in the Q3 weekly expansion cohorts at two five milligrams per kilogram.

We continue to evaluate dosing on an alternate schedule of weekly dosing for three weeks on, followed by one week off drug to better understand the impact of more frequent dosing. We are currently studying an expansion cohort for weekly dosing at 1.5 milligrams per kilogram while in parallel, continuing dose escalation for a weekly regimen of 1.75 milligrams per kilogram.

We continue to evaluate dosing on an alternate schedule of weekly dosing for three weeks on followed by one week off drug to better understand the impact of more frequent dosing.

We are currently studying an expansion cohort for weekly dosing at one five milligrams per kilogram, while in parallel continuing dose escalation for a weekly regimen of 175 milligrams per kilogram.

We continue to be encouraged by the progression of this study, and we look forward to sharing the complete phase one data findings at a medical conference later this year, together with next steps in the clinical development plan for ZW49.

We continue to be encouraged by the progression of the study and we look forward to sharing the complete phase one data findings at a medical conference later this year together with next steps in the clinical development plan for <unk> to be 49.

This quarter, we also highlighted a topic that is worth repeating here. In March, at World ADC London, our team presented information detailing our next-generation TOPO-based ADC platform. We are excited about this new technology, as it expands the scope of our existing ZymLink ADC platform beyond traditional Oristatins and provides Zymeworks and potential partners the ability to select indication-specific payloads.

This quarter, we also highlighted a topic that it's worth repeating here.

In March at World ADC, London, our team presented information detailing our next generation <unk> based ADC platform.

We are excited about this new technology as it expands the scope of our existing Zyme link ADC platform beyond traditional or a statin and provides <unk> and potential partners the ability to select indication specific payloads.

Again, this enables development of clinically and commercially relevant topo-antibody drug conjugates that are shown preclinically to be potent, selective, and importantly, bystander, The approach to generate these potential topo-based therapeutic candidates centered around an initial panel of Kemp-Tilthectin-derived payloads with multiple lead chemistries, identified exhibiting favorable biophysical properties, and a range of potency and bystander activities, we were able to benchmark, and we believe, improve upon current ADCs in development by our competitors.

Again, this enables development of clinically and commercially relevant topel antibody drug conjugates that are shown pre clinically to be potent selective and importantly bystander active.

The approach to generate these potential total based therapeutic candidates centered around an initial panel as tempt to affect and derive payloads with multiple lead chemistries identified exhibiting favorable biophysical properties and a range of potency and bystander activities, we were able to benchmark and we believe.

Improve upon current adcs in development by our competitors with preclinical PK characteristics similar to our parental antibody strong efficacy across multiple different tumor associated antigens and diverse preclinical xenograft models and an excellent tolerability profile in preclinical models.

With preclinical PK characteristics similar to a parental antibody, strong efficacy across multiple different tumor-associated antigens in diverse preclinical xenograft models, and an excellent tolerability profile in preclinical models, suggesting a favorable therapeutic index, We believe that our topo-based payloads will complement our existing or statin-based payload technology, which is currently used in ZW49, and allow further fit-for-purpose and indication-specific creation of ADCs.

Suggesting a favorable therapeutic index, we believe that our Tokyo based payloads will complement our existing or statin based payload technology, which is currently used in <unk> to be 49 and allow further fit for purpose and indication specific creation of adcs.

We look forward to sharing more details on the next generation topo-based therapeutic candidates, as well as potential multi-specific therapeutic candidates in our preclinical pipeline with progress throughout the year and at our early stage R&D day, scheduled for later this year.

We look forward to sharing more details on the next generation total based therapeutic candidates as well as potential multi specific therapeutic candidates in our preclinical pipeline with progress throughout the year and that our early stage R&D day scheduled for later this year.

I would like to restate that our corporate goal, as outlined in January, is to advance two new product candidates that utilize our proprietary platform technologies and to submit two IND applications by the end of 2024.

I would like to restate that our corporate goal as outlined in January is to advance two new product candidates that utilize our proprietary platform technologies and to submit two IND applications by the end of 2024.

We are encouraged and excited by the preclinical results we've seen to date and look forward to sharing more about these programs and the supporting data at our R&D day in the fourth quarter.

We are encouraged and excited by the preclinical results we've seen to date and look forward to sharing more about these programs and the supporting data at our R&D day in the fourth quarter.

In addition, I'd like to remind everyone that our data presentations are available on our website at www.zymeworks.com slash publication.

In addition, I'd like to remind everyone that our data presentations are available on our website at www Dot <unk> dot com slash publications.

Since we detailed our key priorities in January, we have already made significant progress on many of these objectives, to highlight a few.

So hopefully you've seen from the performance out of the quarterly we just announced that we are working very hard and very urgently around the priorities they set out as a new CEO in mid-January, and that's independent of, you know, the worst biotech stock market we've seen in a long time.

Since we detailed our key priorities in January we have already made significant progress on many of these objectives.

To highlight a few.

He said we would improve our balance.

We said, we would improve our balance sheet.

And we successfully closed a public offering against a very challenging macroeconomic backdrop and in parallel executed on a reduction in workforce in parallel with a focus on priority R&D programs.

And I think we're very focused as a team.

I think things are going very well. I think I'm ahead of schedule in the reset that we want to make in the organization, and I think we're going to see that as the year goes along, that you'll hopefully continue to see operating performance that meets all the priorities and deadlines we have, hopefully exceeds, continues to exceed expectations around that.

And we successfully closed a public offering against a very challenging macroeconomic backdrop and in parallel executed on a reduction in workforce in parallel with a focus on priority R&D programs ahead of our target schedule.

And I think we're really looking forward to reporting progress in the weeks and months ahead to you on the things that we outlined today.

We said that we would fully recruit our pivotal study, Horizon BTC01, by the middle of this year. And as I noted earlier, we have completed enrollment ahead of expectations and our previous guide. We said we would present updated Xanadatomab data at a major medical meeting.

So thank you for your attention.

We said that we would fully recruit our pivotal study horizon BTC zero, one by the middle of this year.

And as I noted earlier.

We have completed enrollment ahead of expectations and our previous guidance.

We said, we would present updated zenna data map data at a major medical meeting and again as I noted earlier on this call data from Zanna data Mab in combination with <unk> and chemo in first line gastric setting as well as Ana data map in combination with chemo in first line breast cancer setting will be <unk>.

And again, as I noted earlier on this call, data from Xanadatomab in combination with Tizolizumab and chemo in the first-line gastric setting, as well as Xanadatomab in combination with chemo in the first-line breast cancer setting will be presented at ASCO by our partner Bayesian.

Really look forward to seeing you at ASCO if you're there or listening in on the investor webcast.

And we look forward to talking more about XIMEworks and specifically data math at ASCO.

<unk> by our partner Beijing.

We said we would continue to work towards improving our balance sheet, and we continue to make good progress on completing other non-dilutive funding initiatives that will extend our cash runway, as well as being very active in discussions on new partnerships and collaborations that should secure funding for our planned operations beyond 2023.

So thank you very much.

We said, we would continue to work towards improving our balance sheet and we continue to make good progress on completing other non dilutive funding initiatives that will extend our cash runway as well as being very active in discussions on new partnerships and collaborations that should secure funding for our planned operations beyond 2023.

And finally, we said we would continue to advance our core technology platforms, and more importantly, communicate the value creation catalyzed by our investment in R&D. And we presented our new Topo-based payload at World ADC London.

Thank you, ladies and gentlemen.

And finally, we said we would continue to advance our core technology platforms and more importantly, communicate the value creation catalyzed by our investment in R&D and.

We presented our new Tokyo based payload at World ADC London.

And we remain committed to building on this R&D momentum over the course of this year and remain on track for two new I&D filings by the end of 2024.

And we remain committed to building on this R&D momentum over the course of this year and remain on track for two new IND filings by the end of 2024.

Closing.

This concludes today's conference call.

In closing.

Our board and management team are acutely focused on building shareholder value through delivering on all of the 2022 and 2023 priorities we outlined in January.

Our board and management team are acutely focused on building shareholder value through delivering on all of the 2022 and 2023 priorities we outlined in January .

Hopefully exceeding expectations for our operating performance.

And hopefully exceeding expectations for our operating performance.

With more to come in the coming months with respect to data updates for Xanadat and Mabedasko and other medical conferences, a comprehensive update on ZW49, and various presentations pertaining to our preclinical portfolio and R&D activities.

With more to come in the coming months with respect to data updates presented data <unk> and other medical conferences.

A comprehensive update on the <unk> 49, and various presentations pertaining to our preclinical portfolio and R&D activities I know I speak on behalf of our entire company.

I know I speak on behalf of our entire company when I say we are very excited about the future of this company and we are committed to delivering upon our goals in a manner that benefits both our patients and our shareholders.

You may now...

I'd say, we are very excited about the future of this company and we are committed to delivering upon our goals in a manner that benefits, both our patients and our shareholders.

With that, I will turn the call over to the operator to begin the question-and-answer session, with me today.

With that I will turn the call over to the operator to begin the question and answer session.

Goodbye.

With me today.

Kenneth Galbraith.

Kenneth Galbraith.

Our Chief Medical Officer, Dr. Neal Josephson, and our Chief Financial Officer, Chris Astle.

[music]

Our Chief Medical Officer, Dr. Neil Josephson, and our Chief Financial Officer, Chris Astley.

Yeah.

The first question is from Stephen Willey, which...

Your first question is from Stephen Willey with Stifel.

Go ahead.

Please go ahead.

Yeah, good afternoon, guys.

Yeah. Good afternoon, guys. Thanks for taking the questions.

Understood that there's probably not much to say regarding the.

The Blue Falcon update.

Update here, but.

Just with respect to the ask of updates is there anything that you can say.

Just with respect to expectations around patient numbers and then maybe just anything that you may be able to say around the expected duration of follow up that we should be.

Looking forward in the.

And the <unk> in the frontline metastatic breast presentations.

Thanks for taking the questions.

Yes, thanks for the question.

David.

On your first part and I'll, let Dr. Joseph.

The <unk> point.

Sure.

We made a written statement last week.

Understood that there's probably not much to say regarding the Blue Falcon update here.

Also what I received.

It really kind of a bit more than that at this point as we indicated in that statement.

On the start of this call I think I can just assure you that.

Everything we do here at <unk>.

Just curious the certain the professionalism and with the interest of all shareholders in mind.

As we act in our business.

I think when we have something further to say publicly beyond this last week, we will make it.

As appropriate and necessary and told that I think any private discussions we choose to have with the <unk>.

We have presented the letter or other third parties that we might engagement discussions with.

We will remain private until it's appropriate or necessary to have a further public statements.

Really all we can say right.

Right now I'll just.

Pass it over to Neil Josephson to answer the question.

Just with respect to the ASCO updates, is there anything that you can say just with respect to expectations around patient numbers and then maybe just anything that you may be able to say around the expected duration of follow-up that we should be looking for in the GEA and the frontline metastatic breast presentation?

Sure. Thanks for the question so.

Thanks for the question, Stephen, and just first on your first point, I'll let Dr. Josephson answer the ASCO point, but you know, we made a written statement last week, of the letter we received.

As was discussed this is phase one b phase II slash phase II data and I think it's.

And it really can't fit more than that at this point, as indicated in that statement.

And also, on the start of this call, I think, you know, I can just assure you that, you know, as with Everything we do here at Zymeworks, we act with seriousness, urgency, professionalism, and with the interests of all shareholders in mind as we, As we act in our business, I think when we have something further to say publicly beyond the statement last week, we will make it as appropriate and necessary.

I think until then, I think any private discussions we choose to have with the group that sent us the letter or other third parties that we might engage with, discussions with, will remain private until it's appropriate and necessary to have a further public statement.

From a high level point of view, it's going to be similar in terms of the patient numbers to what you've seen us present previously when phase II data has been presented this is based on the presentation, but the numbers are going to be similar to what you've seen in the past.

I think that's really all we can say right now, and I'll just pass it over to Neil Josephson to answer the ask the question.

Sure, thanks for the question.

So, as was discussed, this is, you know, phase 1B, phase 2, slash phase 2 data.

And I think it's, you know, from a high level point of view, it's gonna be similar in terms of the patient numbers to what you've seen us present previously when phase 2 data has been presented.

This is Beijing's presentation, but the numbers are gonna be similar to what you've seen in the past.

And in terms of the duration of follow up these are both interim data cuts.

And in terms of the duration of follow-up, these are both interim data cuts, you know, specifically for GEA.

Specifically for GE.

Again, I think that if you look at our previous presentations, you can get an idea of, you know, how much follow-up in general we're going to have.

Again, I think that if you look at our previous presentations you can get an idea of of Av.

How how much follow up in general we're going to have so we'll have some duration of response, but it's still it's still an interim data cut and then in breast cancer.

So, we'll have some duration of response, but it's still, you know, an interim data cut.

And then in breast cancer, you know, the maturity of data really needs to be such that it is out for a while, if you're looking at a duration of response, just because the standard of care in that setting has such a longer progression pre-survival.

Yes.

<unk>.

<unk>.

Maturity of data really needs to be such that it is out for a while if youre if youre looking at duration of response.

Just because the standard of care in that setting has such a such a.

A longer progression free survival.

So, you know, this is an interim data cut.

So.

This is an interim data cut for both of those I would say that it's going to be from the standpoint of duration less mature from the breast cancer standpoint.

For both of those, I would say that it's gonna be, from the standpoint of duration, less mature from the breast cancer standpoint.

Okay, that's helpful.

Okay. That's helpful and I know that there is a lot of discussion around trying to procure non dilutive.

Funding through various collaborative structures and I guess can.

Can you speak to the preference for doing more earlier stage platform oriented deals versus I guess.

Transactions that are focused around specific assets I mean, it kind of seems like the former maybe you wont necessarily inflict the balance sheet I.

I know that you are probably somewhat limited on the ladder, but if you could just.

Maybe speak a little bit to where youre spending most of your time.

On the on the collaborative front right now thanks.

And I know that there's a lot of discussion around trying to procure non-dilutive funding through various collaborative structures.

Yeah sure I can do that.

Hey, good morning.

Financial options, we can pursue that are non dilutive.

Which could strengthen that position further I think we talked about some of those earlier this year when we talked about the strategy of strengthening our financial position and a series of steps.

And I guess, Can you speak to the preference for doing more earlier stage, platform oriented deals versus, I guess, Transactions that are focused around specific assets.

Over a period of time, which is what we have been doing.

So as soon as we have more of those completed.

Just talk about them I think.

I mean, it kind of seems like the former maybe won't necessarily inflect the balance sheet.

If you go back to January one of the things I talked about earlier.

The changes in strategy works when I took over.

Was to try and have the strategy ultimately integration partnerships and collaboration throughout the product portfolio.

And this strategy was simple.

By doing that.

Salaries, the timing and development.

On behalf of <unk>.

Rod in our program scope beyond the current studies, which we have ongoing.

Through our commercial competitiveness.

Leverage our shareholder investment capital with Barclays capital.

And all of those were structured to improve the long term value of our R&D programs beyond what we could have done on our own without those partnerships in place.

I know that you're probably somewhat limited on the latter, but if you can just, maybe speak a little bit to where you're spending most of your time on the collaborative front right now.

I think we've been very active and busy.

Since then and discussing interest from quality companies throughout the product portfolio.

Because I think our goal is to find ways to integrate partnerships and cooperation successively throughout everything we do both pre clinically and clinically and I think as we are coming to announce.

And completed arrangements throughout the portfolio and then we will obviously talk about.

Okay. That's very helpful. Thanks for taking the questions.

Thank you.

Thanks.

Once again, ladies and gentlemen, if you have a question. Please press star one on your telephone keypad again star one on your telephone keypad. Your next question is from Eagle Docomo <unk> with Citi. Please go ahead.

Yeah, sure, I can do that.

Hi, Tim This is <unk> on for Yigal, Thanks for taking my questions.

And I guess there's two things. One, there's some financial options we can pursue that are non-dilutive, which could, you know, strengthen the financial position further.

I think we talked about some of those earlier this year, when we talked about the strategy of, you know, strengthening our financial position in a series of steps over a period of time, which is what we have been doing.

So as soon as we have more of those complete, then you'll see us talk about them.

I think if you go back to January, one of the things I talked about early on about, you know, any changes in strategy for Zymeworks when I took over was to try and have the strategy of more fulfillingly integrating partnerships and collaborations throughout the product portfolio. And the strategy was simple, we could, you know, find ways by doing that to accelerate the timing of development beyond what we currently have, to broaden our program scope beyond the current studies which we have ongoing, you know, improve our commercial competitiveness.

We were able to leverage our shareholder investment capital with partner's capital and all of those were structured to improve the long term value of our R&D programs beyond what we could have done on our own without those partnerships in place.

I think we've been very active and busy since then in discussing interests from quality companies throughout the product portfolio.

How should we interpret ESCO choosing not to grant an oral or poster presentation for your CDK four six combo.

Because I think our goal is to find ways to integrate Parkinson's collaboration successively throughout everything we do, both preclinically and clinically.

In late line breast cancer.

Just not enough data and maybe how much data were you intending to present and maybe how much more will you present later this year in the fourth quarter.

No good question.

Neil Jay do you want to talk about that.

Yes, I mean, its hard for me to speculate as to why <unk> made decision why ESCO makes decisions.

<unk>.

I can say that that again. This is this is an interim data cut.

So the presentation later on will be a more mature version of an interim data cut we're still enrolling into the study.

We're very excited about the results.

And interested in sharing those results, but we wanted to share the results.

In a way in which people could evaluate them more fully than just in an abstract so for that reason, we made a decision to.

Sure.

Submit to a subsequent meeting.

Okay.

Maybe I'll sneak in one on nearly 49.

I guess when can we expect some strategic updates regarding which tumor types youll be advancing.

Got it.

It seems likely to be after the data in the second half, but is there any chance you might provide some strategic clarity before that.

Yes.

Please go ahead, John just okay, no I can take that one.

I think we've been in addition to continuing to dose the study and we gave you an update on our progress today I think <unk> been working very hard to determine what the next study for us and it looks like the next cargo side. It looks like <unk> 49 on the basis that we find acceptable dosing regimen to move forward with.

And I think as we have something to announce in completed arrangements throughout the portfolio, then we will obviously talk about it.

And I think as soon as we're comfortable talking about the structure and timing of that.

Which could be in advance.

Presenting all the data.

Then we will do so so I think as soon as we have enough uncertainty.

What we want to do we'll obviously talk about that is not dependent on partners.

Having the full phase one data set.

All of them here.

Okay, that's very helpful.

Okay, great. Thanks for the clarity.

Your next question is from the line of Charles <unk> with Guggenheim Securities. Please go ahead.

Thanks for taking the questions.

Oh, Hey, good afternoon, guys and thanks for taking my questions I do have a few if you don't mind, but just to.

Once again, ladies and gentlemen, if you have a question, please press star 1 on your telephone keypad.

Again, it's star 1 on your telephone keypad.

Start off really quickly what are the benchmarks that you would potentially need to hit for horizon BTC in second line disease and how should we also think about those benchmarks not only across the entire study, but also potentially on a cohort by cohort basis stratified IHT score. Thanks.

Your next question is from Yigal Nochomovitz with Citi.

Please go ahead.

Jay do you want to pick up.

Hi Dean, this is Ashiq Mubarack on Freegal.

Sure. So I think if you look at AD patients who.

Don't have.

Most patients I should say with with.

Thanks for taking my questions.

How should we interpret ASCO choosing not to grant an oral or poster presentation for your CDK4-6 combo in late-line breast cancer?

I mean, was there just not enough data, and maybe how much data were you intending to present, and maybe how much more will you present later this year in the fourth quarter?

Biliary tract cancer once they get out of the first line of treatment unless they're eligible for something like an <unk> inhibitor.

No, good question.

There really is no standard of care.

So if you look back at the agency.

Six study really combination chemotherapy, which will be available to most patients gives.

<unk> single digit response rates.

And not a meaningful.

<unk> survival over best supportive care. So this is an area of significant unmet need.

I think if you look at our phase one data in biliary tract cancer and you can see that we have we have a very active molecule in patients who are.

Who have had previous treatment and so.

I can't speak to exactly what the FDA would say is needed for approval.

Approval, but what I can say is that is that the activity that we've seen both from the from the standpoint of.

Response rates and duration of response are significantly better.

And then what you would expect to see if patients were treated with chemotherapy.

And when we have all the data we will present it to the FDA in conjunction with the safety data and.

And the decision will be made based on the totality of that data in terms of.

Of how to evaluate patients based on IHT status.

The study has two cohorts cohort one.

As a patient population.

IHT two plus three plus patients all the patients in the study has to have amplification that as the primary efficacy evaluable cohorts that is the cohort that.

Patients that that.

The FDA will primarily look at R. R.

How it approval is given the second cohort the IH seek euro at one plus that is an exploratory population of patients. So.

So we want to see a if there are a lot of patients.

That don't express it at high levels, and if they and if they do express it at lower levels are they able to get a response to the drug and so all of that information once the study.

It reads out will be available but.

Again.

The IHT two plus three plus population, which is which is generally what in other diseases.

<unk> is being her two positive that would be the primary efficacy evaluable patient population.

Got it that makes sense great.

Are your frontline biliary tract cancer studies progressing could you just quickly remind us of the progress on that front. Thanks.

Yes so.

Yes, im happy to take that as well.

So we are we.

We have a phase II study that is enrolling those patients and it is actively enrolling now.

Got it okay, and if I could just squeeze one more in across your partnered assets, which includes <unk> XP <unk> two into two T cell engages over at J&J, you should potentially where they should I should say have first in human clinical data, perhaps throughout the second half of this year.

Next year as well how much line of sight you have into how.

Those studies are progressing and to what extent have you included those potential near term milestones into your runway guidance. Thanks.

Yes, good question.

We have line of sight from partners about the program, we don't talk about it publicly so we maintain our confidentially so.

They're all great partners, we hope they make progress with those agents that they have.

So far so we only report out.

We let them for reporting our progress and we just reported out milestones that we receive.

As a general rule, we do not incorporate future milestones into our cash flow forecasting.

Upside just so we don't forecast.

Pardon me and collaboration strategy that we're undertaking right now we don't forecast that into our cash flow around minus the only things that we know we're going to have is what we talked about when we talk about second half.

23%, obviously, you'll get some of these non dilutive financing initiatives.

Or are we receive more milestones from our early legacy agreements or once we get partnership transaction.

The closed and announced that we will give update on guidance. So we tend to be very conservative about the cash.

Runway.

Got it great. Thanks for taking all my questions.

Okay.

Next question is from Josh <unk> with Evercore. Please go ahead.

Thanks for taking the question.

As we look forward to additional data for <unk> in breast cancer, given the competitive space for her two targeting agents, maybe you can give us a sense of the type of profile you are looking for in order to advance that into further studies. Thank you.

Neil J., do you want to talk about that?

Jay do you want to take that one too.

Sure I think that you have to understand the way that we're developing Santa data I'm, having breast cancer, we are developing it as it is.

Combination agents, so where we're developing again in <unk>.

Areas in which.

<unk>.

Other Hartford targeted therapies are.

Used as combination agent and so so from that standpoint.

The benchmarks or the benchmark score.

The agents that are available and standard of care in different lines of therapy. We are developing at both in late line and early line and so so I mean I think if you just look at what standard of care is those are the benchmarks that were that were thinking about when we are.

Sure.

Just thinking about about where we can develop and where it will serve patients the best.

Your next question is from Jessica Fye with Jpmorgan. Please go ahead.

Hi, This is Nick on for Jessica Thanks for taking our questions.

Yeah, I mean, it's hard for me to speculate as to why ASCO made decisions, why ASCO makes decisions.

And you may not be able to comment on this but wanted to see if you guys have thought about re engaging or if you have re engaged with strategics following the unsolicited bid from all the Falcons.

You know, I can say that, again, this is an interim data cut, so the presentation later on will be a more mature version of an interim data cut.

Well I guess.

We're still enrolling into the study.

What I can say mid January we talked about the fact that we wanted to.

Have a more fulsome strategy around integrating partnerships and collaborations into our entire product portfolio for the reasons that I outlined.

So we've been engaged in discussions with.

Parties with regards to their interest in <unk>.

In one or more partnerships or collaboration that involve one or more of.

The programs that we have Danny is going to be 49.

Preclinical touhou nexgen platform and the multi specific antibody therapeutic platform.

I will discuss it might be now discuss what might be broad.

We're very excited about the results and interested in sharing those results, but we wanted to share the results in a way in which people could evaluate them more fully than just in an abstract.

So, for that reason, we made a decision to submit to a subsequent meeting.

So we have a pretty opening engagement with a host of strategic parties.

And that's been ongoing since I got here.

Okay.

And we will continue to be ongoing as we look how to integrate these things.

Build long term value of the company that we Couldnt do if we didnt have those perished.

Great. Thank you for taking my questions.

Sure.

Maybe I'll sneak in one on ZW49.

Your next question is from Nick Abbott with Wells Fargo. Please go ahead.

I guess, when can we expect some strategic updates regarding which tumor types you'll be advancing?

Jonathan Thanks for taking the questions.

With BTC can you tell us what proportion of patients who enrolled in China and Korea versus outside of those territories and when is the earliest the company would be ready to file a BLA.

That seems likely to be after the data in the second half, but is there any chance you might provide some strategic clarity before that?

Yeah, I think I can take that one.

Good question, Neil Jay do you want to do you want to.

Thanks, Andy I'm going to answer that one.

Yeah, I don't think we're going to we're going to talk specifically about about.

Exactly where patients are being enrolled from but but I can tell you that it is.

It is a.

A disease that is is more prevalent in Asian countries, but it's also prevalent in South America and.

And also in <unk>.

Terms of if youre thinking about our.

Territory.

Which we still have.

Ownership of <unk>.

And in Japan.

BPC is definitely a disease that is that is.

Significant.

In territory that we that we can control.

And we have we have.

Enrolled at globally basically.

That's what I can say.

Please go ahead.

I don't know Ken do you want to talk about.

The approval.

Approach or.

Do you want to do that one?

Yes, I think we'll just because we are first of all has to work.

Yeah, okay.

No, I can take that one, Neal.

You know, I think we've been, in addition to continuing to dose the study, and we gave you an update on progress today, I think we've been working very hard to determine what the next study for Zannie looks like and what the next clinical study looks like for ZW49 on the basis that we find an acceptable dosing regimen to move forward with.

Very cohesively with Beijing to get that study fully recruited.

Happy that we did that earlier than we might have thought when I got here in January I think it's a good cooperation with Beijing.

And I think as soon as we're comfortable talking about the structure and timing of that, which could be in advance of presenting all the data, then we'll do so.

That's important because it obviously starts to talk on when the data will be available from that study for us to discuss with regulatory agencies not just in the U S and.

All of the areas that we have.

The filing by ourselves or with or <unk>.

Operationally Beijing, so we've guided.

Data being available by early 2023, obviously, if it's possible to do it sooner we would I think once we get to that point, we'll be in a position to discuss the next steps.

Discuss the regulatory agencies globally, where necessary.

And where we can set timing for approval, whether it's in Beijing in territory in China.

Our offerings are ours.

Ultimately, we can be guiding.

The timing and nature of those regulatory filings.

And again, we ran those values on a global basis.

Hoping there would support regulatory filings in many countries and to the extent, we have other requirements for regional or local studies for filing for approval.

Once we have the data available.

So I think as soon as we have enough certainty of what we want to do, we'll obviously talk about that.

So I think until we get that we just didn't get ahead of ourselves.

And it's not dependent on doing it at the same time.

As having the full Phase 1 dataset available in peer review.

Okay, great.

Thanks for the clarity.

On timing, we would be giving guidance.

The study it sooner and we're getting some of the data has been available and once we get to that point, we'll give more guidance about what that means for filings.

Your next question is from the line of Charles Zhu with Guggenheim.

Potential approvals, depending upon whether that accelerated.

Pathway, which is available.

Some of these already.

Okay.

Hey, good afternoon, guys, and thanks for taking my questions.

Okay, but you mentioned in the prepared comments that you've spent a lot of money in manufacturing and <unk> runs.

I do have a few, if you don't mind, but just to, you know, start off really quickly, what are the benchmarks that you potentially need to hit for Horizon BTC and second-line disease?

And how should we also think about those benchmarks, not only across the entire study, but also potentially on a cohort-by-cohort basis, stratified by IHC score?

Thanks.

Can we take the products supply.

Good question.

It doesn't seem like there's any real obstacles.

There are CMC goes.

Neil J., do you want to take that one?

It's really just the data sufficiency to support.

Registration.

Yes, we decided to accelerate investment in CMC look into Q runs.

So that that would not be a limiting factor to any filing strategy.

That may be possible quicker than you might think so.

We're hopeful that by the end of this year, we will have satisfied all the requirements that we need to make.

Any product, we make with respect to CMC and we've got a high quality group that are working really well and I think that we will not be a limiting factor to decisions about when and where to file.

For Danny in BTC and that was strategic to have resolved, but I think that will help us.

Accelerate the process once we look at our data.

Okay and then.

Also another question I think you said, they're sort of wide ranging partnerships on <unk>.

Boeing wide ranging scope with various partners.

So, I think if you look at patients who don't have, you know, most patients, I should say, with biliary tract cancer, once they get out of the first line of treatment, unless they're eligible for something like an FGFR inhibitor, there really is no standard of care.

So, if you look back at the ABC, you know, 06 study, really, combination chemotherapy, which would be available to most patients, gives you single-digit response rates and not a meaningful prolongation of survival over best supportive care.

Given the.

So, this is an area of significant unmet need. I think if you look at our Phase 1 data in biliary tract cancer, you can see that we have a very active molecule in patients who've had previous treatment.

And so, you know, I can't speak to exactly what the FDA would say is needed for approval, but what I can say is that the activity that we've seen, both from the standpoint of response rates and duration of response, are significantly better than what you'd expect to see if patients were treated with chemotherapy.

Does this change the tenor of the timelines specifically is.

And when we have all the data, we will present it to the FDA in conjunction with the safety data, and a decision will be made based on the totality of that data.

In terms of how to evaluate patients based on IHC status, the study has two cohorts. Cohort 1 is a patient population of IHC 2-plus and 3-plus patients.

All the patients in the study have to have amplification.

That is the primary efficacy valuable cohort.

<unk> partnership.

That is the cohort of patients that, you know, the FDA will primarily look at for how approval is given.

The second cohort, the IHC 0 and 1-plus, that is an exploratory population of patients.

No I think.

So, we want to see, A, if there are a lot of patients that don't express at high levels, and if they do express at lower levels, are they able to get a response to the drug?

And so, all of that information, once the study reads out, will be available.

I think the trend are we set up.

But, again, it's the IHC 2-plus and 3-plus population, which is generally what, in other diseases, is considered as being HER2-positive.

That would be the primary efficacy of a patient population.

Got it.

First got here, so I think all of the contracts you've had with.

That makes sense.

Potential partners.

We would have talked to before or who are new to evaluating.

Evaluating the potential for partnership operations no that we're very open to looking at different structures different options.

In which we can engage them. So I don't think that has changed at all with the letter we got from the <unk> you mentioned.

I think part of our strategy you've talked about in our equity financing. We completed in January was to give ourselves the ability.

To do this in a very matter of fashion.

Now that we've got to pick the highest quality partners and the best terms possible.

Once we find the right partner and the right collaboration to the right financial terms, we think work for our investors and that structure.

We can move to closeout wanted continued discussions on the other Brian I think overall, we'd like to see the ability to integrate these.

These collaborations in different ways throughout the product portfolio from early right through to Danny and the goal is to complete all of that.

In an appropriate structure framework with the right partners.

Over a period of time is probably not as long as as you might say.

Okay, great. Thank you.

Great.

One for me can you talk a little bit about data expectations from.

And how are your frontline biliary tract cancer studies progressing?

Could you just quickly remind us on progress on that front?

Thanks.

Any indications such as colorectal alone.

Yeah.

Okay.

Yes, Neil did you want to talk about any.

Although we've given any guidance on that yet.

May give some that are after presentation, but anything else you want its Daniel.

Other indications.

So, yeah, I'm happy to take that as well, you know, so we are, we have a Phase 2 study that is enrolling those patients and it is actively enrolling.

Yes.

We are enrolling phase II.

Faced in a phase II study, we have a cohort.

Got it.

Frontline colorectal cancer patients.

We are.

Okay.

But we don't have any guidance about when that data will be presented.

And if I could just squeeze one more in.

Okay. Thank you.

Across your partnered assets, which includes XLX's XP002 and the two T cell engagers over at J&J, you should potentially, or they should, I should say, have first-in-human clinical data perhaps throughout second half of this year into next year as well.

Your next.

Question is from <unk> <unk> with Jefferies. Please go ahead.

How much line of sight do you have into, you know, how those studies are progressing?

Hey, guys. Thanks, so much for taking my questions. So maybe more holistically.

Both the previous management team at <unk> and the current one.

<unk> talked about a potential partnership on Dwt 25, but it hasnt seem to come to fruition yet what data do you think we can show in <unk> that might make a strategic partner get interested right is there a certain catalyst that you think partners are looking for in order to validate the platform and to justify further investment.

Additionally, what is a formal offer entailed versus all blue versus the ones. You've already received is there a general timeline for how long the review will lap and lastly for BTC and Gea, what would be the cost needed to fully fund those trials and get them onto the market for GW 25. Thank you.

And to what extent have you included those potential near-term milestones into your runway guidance?

Thanks for all those questions, we'll answer as many as I can sorry.

So as I said earlier on the written statement, we made last week, we can't comment further on any.

Those discussions and hopefully we can clearly ahead of us.

Straightforward I think once we have something to talk about.

Then we will.

When it's appropriate and required.

Occupations on that.

I can't comment to the partnering.

Collaboration discussions before I got here as CEO .

All I can say is that the.

A new CEO , who started it in January I was very clear with all of the folks we've talked to add new folks about our openness to considering a multitude of different structures.

And our desire to partner and collaborate.

Much more than we had before in building. This company from early stage to late stage I think that's it.

Really clearly understood by.

A lot of potential pharmaceutical partners out there.

They all have my mobile phone number that you can pick it up if there's any interest. So I don't think we need to worry about our openness to to engage with them. Obviously, we we havent gave some of the previously under CDA with prior data sets.

We are able to interact with them now under confidentiality agreements and shared data in advance of the peer review setting that you discussed.

And that would apply presumably fortinet as well so I don't think theres anything thats folks that women will need to wait for Vasco.

We did have the ability to ability to get more real time data under confidentiality and restrictions that you would understand.

So I think we're very open to engage we're ready to open the structures around partnerships collaborations as long as they work for building value for our investors and I think those discussions are active and busy.

As soon as we have the right partner for the right program at the right pricing structure that works for our investors. Then we will conclude that deal announcements I don't think anybody's and that process is waiting for.

Additional datasets that might come up.

<unk>.

Thanks, so much.

And your last question about the cost, but we haven't given guidance around that so we obviously know where our cash runway as we obviously know what we can afford to do on our own versus things that might only be possible for us to start.

Big partner dependent so I think as we give guidance for the next clinical steps for first Danny and VW 49, we will clearly address how we're going to fund those.

Thanks.

Your next question is from David Martin with Bloom Burton. Please go ahead.

Yeah, good question.

Good afternoon. My first question is a follow up to an earlier question on the first line breast star.

To the extent we have line of sight from partners of other programs, we don't talk about it publicly.

Study that's coming up.

So we maintain that confidentially.

So they're all great partners.

You mentioned that you're benchmarking combination data combination regimens with existing her two targeted drugs.

We hope they make progress with those agents as they have so far.

So we only report out, we let them report our programs and we just report out milestones when we receive.

As a general rule, we do not incorporate future milestones into our cash flow forecasting.

That's upside, just so we don't forecast, you know, partnering collaboration strategy that we're undertaking right now.

We don't forecast that into our cash flow runway.

So only things that we know we're going to have is what we talk about when we talk about second half 2023.

And obviously, as we get some of these non-dilutive financing issues complete, or we receive more milestones from our early legacy agreements, or once we get a partnership transaction closed and announced, then we'll give update on guidance.

So we tend to be very conservative about the cash runway.

I think in particular Cleopatra is a good one to look at but how do you view the potential for in her to change the first line hurdle and standard of care and what does that mean for us any going forward.

L J.

Sure.

So in her two it's obviously in a frontline study and has the opportunity to change standard of care in that setting. It's a positive study from the standpoint of efficacy and safety.

I would say that that.

Trastuzumab and purchase a mab, a really well established therapies and.

We will still be well established therapies.

Regardless of the readout of the frontline study with <unk>.

So so from that standpoint.

Can't predict the future to say.

What exactly we are.

Our data will look like versus CRE.

<unk> data from from from this study that's ongoing now, but I can say that that.

When we look at the at the early line landscape that we know that both <unk>, both trastuzumab and and the combination of Trastuzumab and <unk> with a taxane are going to be.

We're going to have a home in early line therapy and so.

When we think about about our approach to developing.

Xena data in breast cancer, we're thinking of it along the lines of.

A combination as it works.

Okay.

And then my second question.

It is about the offer but it's mainly asking for a clarification.

You emphasized that it was unsolicited and non binding and I'm wondering if that means to you that you don't need to engage with all blue Falcon.

Until they make a formal offer or is it something.

Am I interpreting that wrong like it is something that you should be engaging with them.

No I think the comment I mentioned before was clear I mean, we got a letter all we know is what was then the letter.

And the security bond that's all we know.

We did put a written statement last week, saying that we have received it.

And we were studying it appropriately.

We would as.

Ted.

Real serious as we do everything with.

Urgency.

Specialist in the interest of all shareholders there.

What we specifically decided to do next.

Private discussions we.

We will do that.

We will make a public statement when it's appropriate and necessary I don't think we will talk about the next steps until we've made any determination of what those are.

So I shouldn't read into that.

Sure.

<unk>, one way or the other I guess wait wait and see what happens.

Yes, I think you can choose I'm sure others will read into a lot of us right.

I think we made a written statement last week, which I think was pretty clear in the call.

I've made today.

Very clear.

We need to make a public statement about something we will do it as appropriate and necessary. After the work that we need to do internally to do that thank you to extent that we have private discussions with.

With the group that sent us the ladder.

Other third parties would maybe discussions with we'll keep those discussions private.

Such time that is necessary and appropriate to make.

Any of those discussions.

Okay.

Thanks, that's it for me.

Thank you Dave.

Got it.

Your next question is from Gena Wang with Barclays. Please go ahead.

Great.

Hi, Good afternoon. This is Krishna on for Gena. Thank you for taking our questions and.

Operator, your next question is from Josh Schimmer with Every Corps.

Please go ahead.

Thanks for taking the question.

I know this was touched upon before but for the data updates at <unk>.

As we look forward to additional data for Zannie in breast cancer, given the competitive space for her two targeting agents, maybe you can give us a sense of the type of profile you are looking for in order to advance that into further studies.

Thank you.

I know you provided guidance on.

Alright, additional color on patient numbers and follow up.

But I was curious are you able to provide any benchmarks on what we should see in terms of response rates at the Africa updates for both GE and breast cancer.

Neil J, do you want to take that one too?

Dr. Neil Jay do you want to answer that question that you can.

Yes.

<unk>.

And.

In terms of benchmarks I think that.

If you if you want to think about about benchmarks for.

Sure.

What to think about in terms of.

<unk>.

Breast cancer, and we all know the Cleopatra response rates in the first line.

We know that.

The toga and.

The toga and Jacob a response rates.

And PFS.

In gastric cancer, and I think that that those are those are.

The areas that we're going in to with these with these phase II studies and and so.

Data that we would be interested in.

Impairing, two and Theres a lots of.

Caveats about cross study comparisons, but when youre thinking about about what do we need to do to become standard of care you have to look at those those as the benchmark to which you would aspire to.

And your final question is from Robert Burns with each C. Wainright. Please go ahead.

Sure.

Hi, This is Mitchell and thank you for taking our questions. The first one I just wanted to ask again on the ask or data. If you could describe what more we could see qualitatively from the abstract to the presentation.

I think that you have to understand the way that we're developing Xanadatimab in breast cancer. We are developing it as a combination agent.

So we're developing it in areas in which other heart treatment targeted therapies are used as combination agents.

And so from that standpoint, you know, the benchmarks are the benchmarks for the agents that are available and standard of care in different lines of therapy.

We're developing it both in late line and early line.

And so, I mean, I think if you just look at what standard of care is, those are the benchmarks that we're thinking about when we are thinking about where we can develop and where it will serve patients the best.

Your next question is from Jessica Fye with J.P. Morgan.

Okay.

Yeah, I think that that there is there is a little bit longer follow up.

Sure.

Yes.

In the gastric cohort and and in the breast cohort.

But they will obviously be a much more detailed presentation of.

Of of data in terms of our shelling.

Depth of response.

<unk>.

And.

Duration at least what we can show at an interim cut in terms of patients that are still on and how long they've been on in and continuing to respond so you'll get that color.

You can't really get from from an abstract and like I said there'll be Kobe.

A little bit later data cut.

Yeah.

Okay, great. Thank you and.

Yes.

And sorry, just to add we will be scheduling.

An investor webcast at the end of our second presentation.

And so we were able to talk about other aspects of Danny Danny clinical development.

Plans beyond the data you might see in the abstracts and presentations as well as answer your questions.

That may arise from that so we're hoping to have a more fulsome presentation beyond the two specific datasets that are available to answer questions about Danny.

Broadly.

Great. Thank you and.

When thinking about your appetite for business development opportunities. How do you consider have you considered what is a critical mass.

Yes, I think I think it's a little before I think.

The one thing that I did want to take a little bit of a change design works with to try and find a way to to integrate partners and collaboration throughout we throughout the program as I mentioned.

It can allow us to go more quickly.

It can allow us to do things beyond what we currently can do.

It will improve the commercial competitive lineup, we go and I think it is a way to leverage our shareholder capital with partner capital and I think there's a way to do that.

Build long term value doesn't give up upside doesn't take away the possibility.

Future M&A from those partners, our existing partners or new parties. So I think as a way to do that well done that before.

And I think if you look at <unk> do you think you're in Asia. As an example, where I don't think it was necessary entirely for thankyou. Thank go to need any one.

Foreign hurt you or are there other ADC, they're developing but I think the astrazeneca vessel as a way to bring in a partner.

Give up some economics around the program, but obviously as you seem to be able to build a much broader clinical program more in parallel more timely and improve their commercial competitive for them beyond what they could have done themselves. So.

I think we are.

Im online I'm thinking that there were running two pivotal studies.

With basically as a partner, but mostly on our own and we're able to do that successfully.

There's many things we can do on our own that will work out well in the early stage preclinical pipeline, but there's an opportunity to integrate <unk> the amount of debt that can build a long term value to our own investors.

Opposed to just the partners investors.

Salivating timing breadth of programs.

And I think we can do that in such a way that it is.

Will build value and won't take away.

From future.

<unk>.

Germany is our ability to grow the business around.

Those partnerships.

How we integrate a series of those things throughout the product portfolio what structure, we take with each individual partnership which will probably be different.

Depending on how we engage and we engaged in with the product line is I think we can do that in such a way that will be a stronger company I think more attractive for future value growth.

I think we'll be able to develop more products more quickly.

And improve our competitive so we can get more market share.

Once we get approval for these agents.

I think once we get the first one.

Complete and announced.

We can talk about the rationale for why we missed the way why.

The messaging I just gave you.

And then how it might impact what to think about is the next one.

Beyond that so the timing and structure.

And scope of these will.

It could change over time, depending upon what the first one it looks like maybe the second one and go beyond that so as we unravel as we enroll this strategy with specific transactions. We can talk more about how this is online with the strategy I just laid out.

Okay. That's helpful great. Thanks.

Absolutely and looking forward to it thanks, so much.

Yes.

And that concludes the question and answer session I will now hand, the conference over to Ken <unk> for any closing remarks.

That's great really appreciate your attention and questions today.

Please go ahead.

The business design works. So hopefully you have seen from the performance.

Hi, this is Nick on for Jessica.

The quarter that we just announced that we are working very hard and very urgently around the Bernie I noticed the new seat.

Thanks for taking our questions.

I understand you may not be able to comment on this, but wanted to see if you guys have thought about reengaging, or if you have reengaged with strategics following the unsolicited bid from Aldwych-Halkins.

Well, I guess, you know, what I can say is, you know, mid-January, we talked about the fact that we wanted to.., to have a more fulsome strategy around integrating partnerships and collaborations into our entire product portfolio, for the reasons that I outlined.

In mid January .

So we've been engaged with in discussions with, These are all parties with regards to their interest in one or more, you know, partnership collaborations that involve one or more of the programs that we have. You know, Zany, ZW49, the preclinical, Topo, NextGen, ABC platform, and the multi-specific antibody therapeutic platform.

Anurous that's independent.

Some of those discussions might be narrow, some of those discussions might be broad.

So we have a pretty open engagement with a host of strategic parties, and that's been ongoing since I got here, and will continue to be ongoing as we look how to integrate these things into, build, you know, long-term value in the company that we couldn't do if we didn't have those partnerships.

The worst biotech stock market, we've seen in a long time.

All right, great.

And I think we're very focused as a team.

Thank you for taking our questions.

They're going very well I think I'm ahead of schedule and the reset that we want to make in the organization and I think we're going to see that as the year goes along that Youll hopefully continued operating performance.

Your next question is from Nick Abbott with Wells Fargo.

Good afternoon.

It meets all the parties and deadlines, we have hopefully exceeds continues to exceed expectations around that and I think we're really looking forward to reporting progress in the weeks and months ahead to you on the things that we outlined today. So thank you for your attention we look forward to seeing you.

Thanks for taking our questions.

Starting with BTC, can you tell us what proportion of patients are enrolled in China and Korea versus outside of those territories?

And when is the earliest the company would be ready to file a BTC?

Good question.

Neil, do you want to take that or do you want me to answer that one?

Yeah, I mean, I don't think we're going to talk specifically about, you know, exactly where patients are being enrolled from, but I can tell you that, you know, it is a disease that is more prevalent in Asian countries, but it's also prevalent in South America, and also, you know, in terms of, if you're thinking about our territory, which we still have ownership of XANI in Japan, you know, BPC is definitely a disease that is significant in territory that we control, and, you know, we have enrolled it globally, basically, is what I can say.

I don't know, Ken, do you want to talk about the approval approach, or?

Yeah, I think we'll, so just to be clear, so we, you know, our first goal was to work, very cohesively with Beijing to get that study fully recruited as soon as we could, and I'm happy that we did that earlier than we might have thought when I got here in January.

I think it's good cooperation between us and Beijing.

That's important because it obviously starts the clock on when the data would be available from that study for us to discuss with regulatory agencies, not just in the U.S., but in all the areas that we intend to file by ourselves or in cooperation with Beijing.

I'd ask you if you there or listening in to the Investor webcast and we look forward to talking more about XI works instead, we presented data at.

So, you know, we've guided on, you know, data being available by early 2023.

Obviously, if it's possible to do it sooner, we would.

Your next question is from Akash Tiwari with Jefferies, please go ahead.

I think once we get to that point, we'll be in a position to discuss the next steps, which are to, you know, discuss with regulatory agencies, you know, globally where necessary and where we think we can set timing for approvals, whether it's in Beijing's territory, in China, or Korea, or elsewhere, or ours, then we'll be as fulsome as we can be about guiding the timing and nature of those regulatory filings.

Hey, guys.

And again, we ran those studies on a global basis, hoping they would support regulatory filings in many countries.

Thanks so much for taking my questions.

To the extent we have other requirements for regional or local studies for filing for approval, we'll, you know, we'll set that out once we have the data available and in hand.

So, maybe more holistically, it seems both the previous management team at Zyme and the current one has talked about a potential partnership on ZW25, but it hasn't seemed to have come to fruition yet.

So, I think until we get that, we just won't get ahead of ourselves.

What data do you think we can show at ASCO that might make a strategic partner get interested, right?

On timing, we've been giving guidance, you know, we've given guidance on when we thought we could study it sooner.

Is there a certain catalyst that you think partners are looking for in order to validate the platform and to justify further investment?

We've given guidance on when the data has been available.

Additionally, what does a formal offer entail versus all blue versus the one you've already received?

So thank you very much.

And once we get to that point, we'll give more guidance about what that means for filings and potential approvals, depending upon whether it's an accelerated pathway, which is available in a few countries already for us.

Is there a general timeline for how long your review will last?

Okay, but you mentioned in the prepared comments that you spend a lot of money in manufacturing and PPK runs.

And lastly, for BTC and GEA, what would be the cost needed to fully fund those trials and get them onto the market for ZW25?

Do we take it that product supply doesn't seem like there's any real obstacles as far as CMC goes?

Thank you.

It's really just the data and its sufficiency to support.

Thank you ladies and gentlemen. This concludes today's conference call. You may now disconnect. Thank you Sandra.

Thanks for all those questions.

Registration.

Yeah, we decided to accelerate investment in CMC, including all the PPQ runs, so that that would not be a limiting factor to any filing strategies we could take that may be possible quicker than you might think.

So we're hopeful that by the end of this year, we will have satisfied all the requirements that we need to make in any filings we make with respect to CMC.

We've got a high-quality group that are working really well, and I think that will not be a limiting factor to decisions about when and where to file for VANI and BTC, and that was strategic.

It's ahead of itself, but I think that will help us accelerate the process once we look at our data.

Okay.

And then, you know, and also another question, I think you said they're sort of wide-ranging partnerships.

Goodbye.

Ongoing wide-ranging scope with various partners.

You know, given the, ABFF or does this sort of change the tenor or the timeline specifically as a ZANI partnership?

Well, I'll answer as many as I can.

Um, no, I think, you know, I think the tenor we set up when I first got here, so I think all the contacts we've had with, potential partners we would have talked to before or who are new to evaluating Zymeworks and potential partners for collaboration, know that we're very open to looking at different structures, different options in which we can engage them.

Okay.

So I don't think that has changed at all with the letter we got from the group you mentioned.

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I think a part of our strategy we talked about in our equity financing that we completed in January was to give ourselves the ability to do this in a very mannered fashion, hoping then that we get to pick the highest quality partners and the best deal terms possible.

But once we find the right partner and the right collaboration and the right financial terms we think work for our investors in that structure, we can move to close that one and continue discussions on the other product.

I think overall what we'd like to see is the ability to integrate partnerships and collaborations in different ways throughout the product portfolio from early right through to Zannie and the goal is to complete all of that in an appropriate structure and framework with the right partners over a period of time.

It's probably not as long as you might think.

Okay.

Okay.

Great.

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Thank you.

And the last one for me.

Sorry.

Can you talk a little bit about data expectations from other than indications such as colorectal or lung?

Okay.

Great.

Yeah, Neil, did you want to talk about any?

I don't think we've given any guidance on that yet.

You know, maybe it's not better to ask a presentation, but anything else you want to say, Neil, about other indications?

Yeah, we are enrolling in a Phase II study.

We have a cohort with frontline colorectal cancer patients.

But we don't have any guidance about when that data will be presented.

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