Q4 2019 Earnings Call
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Unnamed: Good morning. And welcome to Mersana Therapeutics' fourth quarter and year-end 2019 conference call. Currently, all participants are in listen-only mode. There will be a question and answer session. At the end of this call, I would now like to turn the call over to Sarah Carmody, Executive Director, Investor Relations, and Corporate Communications. Please proceed.
And welcome to Mersana Therapeutics fourth quarter, and yearend 2019 conference call.
Sarah Carmody: Good morning. Welcome to Mersana's fourth quarter and year-end 2019 conference call. We issued a press release earlier this morning reviewing our fourth quarter 2019 and full-year results and business updates, which will be covered on this call. A replay of today's call will be available on the Investors & Media section of our website.
Currently all participants are in listen only mode. There will be a question and answer session.
At the end of this call I would now let's turn the call over to serve Carmody Executive Director Investor Relations Corporate Communications. Please proceed.
Unnamed: After our prepared remarks, we will open the call for Q&A. Before we begin, I'd like to mention that our call will contain forward-looking statements. These are not statements of historical facts and are based on management's beliefs and assumptions and on information currently available. They are subject to risks and uncertainties that could cause the actual results and the implementation of the company's plans to vary materially, including the risks that early, encouraging preclinical results for XMT 1536 are not necessarily predictive of the results of our ongoing or future discovery programs or clinical studies. That the development and identification of the company's product candidates and new platforms will take longer and or cost more than planned, and that our clinical trials will not be completed on schedule, if at all.
Good morning, welcome to respond as fourth quarter and here in 2019 company.
We issued a press release earlier this morning, redoing, our fourth quarter 2019, and full year results.
Which will be covered on this call.
Replay of today's call will be available on the Investor and media section of our website. After our prepared remarks, we'll open the call for Q.
Before we begin I'd like to mention that ARPU will contain forward looking statement.
It didn't the meaning of federal Securities law.
These are not statements of historical facts in are based on management's beliefs and assumptions and on information currently available they are subject to risks and uncertainties that could cause the actual results and the implementation of the company's plans to material to vary materially including the risks that are early encouraging preclinical results for X.M.T. 15 36.
Not necessarily predictive of the results of our ongoing or future discovery programs, our clinical study.
At the development and identification of the company's product candidate and you platforms will take longer and or cost with the plan and that our clinical trials not be completed on schedule if at all.
Unnamed: These risks are discussed in the company's SEC filings, including, without limitation, the company's annual report on Form 10-K, filed on February 28, 2020, and subsequent filings. Except as required by law, the company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future. And with that, I'll turn the call over to Anna Protopapas, Mersana's Chief Executive Officer
These risks are discussed in the Companys FCC filings, including without limitation. The company's annual report on form 10-K filed on February 20, 2020, and subsequent filings.
Except as required by law the company assumes no obligation to update these forward looking statements publicly even if new information becomes available the teacher and with that I'll turn the call over to Annapurna pumping more sand as chief Executive Officer.
Anna Protopapas: Thank you, Sarah. Good morning, everyone, and welcome to our Financial and Corporate Update call for the fourth quarter of 2019. Joining me today with prepared remarks is Brian DeSchuytner, Senior VP of Finance and Product Strategy. The rest of the management team will be available for your questions.
Thank you Sarah good morning, everyone and welcome to or find there actually put update pool for the fourth quarter 2019.
Joining me today was prepared remark is Brian Brian just show no senior VP of finance corporate strategy. The rest of the management team will be available to your question.
Anna Protopapas: Our accomplishments in 2019 have laid the foundation for a data- and milestone-rich 2020. We made a great deal of headway in advancing 1536 and 1592 and utilizing our innovative ATC platforms to advance our early-stage pipeline, with plans for two first-in-class development candidates in 2020, including a B7H4 dollar-lock ATC and a STING agonist ATC, based on our immunosynthetin I will provide an overview of the status of our clinical and early stage programs and outline our goals and milestones for the remainder of the year, and then Brian will provide our financial results for the fourth quarter and full year 2019. We're going to keep our prepared remarks brief because we just provided a comprehensive corporate update last month in San Francisco.
Our Oh punishment see tutto somebody team, probably the foundation for Adidas and Monster Rich drip in 2000 twin peaks.
We made a great deal of headway in advancing 15, 36, and 50 92, and utilizing our into but PBC platforms TWIC bonds or early stage pipeline with regards to for students lungs development candidates in 2022 D.V. So many each for.
Don't know PTC interesting I couldn't be CPC based on our reviewed assume to blocks and four and they see yet disclosed torn kit.
I will provide an overview of the state to support clinical and early stage programs and outline our goals shouldn't milestones for the remainder of the year, the Brazilian would provide or financial results for the fourth quarter and full year 2019.
Good to keep up with Baird Weve remarks brief because we just provided a comprehensive corporate update last month San Francisco.
Anna Protopapas: I'll start with 1536, our first-in-class and wholly-owned oloflexin ADC targeting NAPI2B. As we disclosed at ASCO in 2019, XMT1536 has shown confirmed responses and prolonged stable disease at well-tolerated doses in very heavily pre-treated and biomarker-unselected patients. Since then, we have made significant progress in demonstrating the safety and activity at higher doses and initiated expansion cohorts, putting us on track to establish proof of concept in 2020. More specifically, we have cleared the 36 and 43 milligrams per meter squared dose level with primarily grade 1 and grade 2 adverse events and without the severe neutropenia, neuropathy, and ocular toxicity seen with other ADC platforms. We have not yet determined a maximum tolerated dose and are currently evaluating the 52 milligram per meter squared dose.
I'll start with 50, so do you see our first two Clos and what would you don't have like CPC targeting dot b to b.
As we disclosed to the high school in 2019, except P. 50 statistics show confirmed responses and prolonged stable disease, well tolerated dose is it very heavily pretreated and biomarker unselected patients.
Today, we have made significant progress in demonstrating safety activity.
Doses and initiated expansion pool coach putting us on track to establish proof of concept in 2020.
More specifically, we have cleared the 36, it 43 billion groups per meter squared dose level was primarily Greek one degree to which C bench and we don't give me a neutral be near you empathy. It ought to look to see C. D C with other HPC platforms.
We have no do you did toward me a Buck Smith told to read it goes it I'm currently evaluating the 52 milligram per meter squared goes.
Anna Protopapas: Importantly, we recently learned that our late-breaker abstract was accepted for an oral presentation of our updated phase one dose escalation data at the upcoming Society of Gynecological Oncology, or SGO, annual meeting on women's cancer in Toronto on March 30th. The SGO Oral Presentation will provide an update on the ongoing dose escalation study, including longer follow-up on patients presented at ASCO 2019 and new patient data from the 30, 36, and 43 milligrams per meter squared dose cohorts. This first disclosure will characterize the tolerability profile of XMT 1536 and demonstrate encouraging early signs of activity in very heavily pretreated and biomarker-unselected patients. The dose escalation data to be presented will include a total of 59 patients. 37 of these patients are ovarian cancer patients, and 11 are non-small cell lung cancer patients.
Importantly, we shouldn't be learn the dog late breaker obstruct was accepted for an oral presentation.
<unk> updated phase one dose escalation data at the upcoming society gynecological oncology or as Gio.
Annual meeting or women's cancer in Toronto.
Sure Yes.
The next few oral presentation will provide an update on the ongoing dose escalation study, including belong to follow up would be shoots presented at ASCO 2019, a new patient data from the 30, 36, 43 milligram per meter squared dose cohorts.
Just first disclosure.
After I said Tolerability profile of X and P. 50, 36, and demonstrated encouraging early signs of activity in very heavily pretreated biomarker selected patients.
Doses can they should begin to be presented really people did totaled 59 patients.
37 of these patients are buried in cancer patients and de lever a non small cell lung cancer patients.
Anna Protopapas: There are also 11 patients with other tumors previously disclosed at ASCO that were treated at lower doses and generally had low levels of NAPI2B expression. The patients in the Dose Escalation Study are very heavily pre-treated and have a very poor prognosis, often having progressed not just on the available therapies but also on investigational therapies. Multiple published studies demonstrate the poor prognosis of these patients and their rapidly deteriorating likelihood of response with increasing lines of therapy. By the third or fourth line of therapy, the response rate approaches zero. Furthermore, these patients have not been selected for expression of the answer.
There are also 11 patients with other two was previously disclosed that school that were treated on lower doses and generally low level. So no P to P expression.
The patients in the dose escalation study I'm very heavily pre treated it is a very poor brookdale. She's also help improve gross no chose to the available therapies, but also what investigational therapies.
Most people published studies demonstrate poor prognosis of these patients and a rapidly deteriorating likelihood of response with increasing lines of therapy.
My third or fourth line of therapy. The response rate approaches to zero. Furthermore, these pieces of not being selected for expression of the on teaching.
Anna Protopapas: The primary focus of the dose escalation study is to assess safety and tolerability, and we will be able to provide information on both short-term safety data, in terms of dose-limited toxicities, as well as longer-term follow-up. As we have communicated before, we're still evaluating 52 milligrams per meter squared, and the data will not be complete enough in time to be disclosed in the SGO presentation.
The primary focus of the dose escalation study is to assess safety and Tolerability and we will be able to provide information or both short term safety data in terms of dose limiting toxicities as well as longer term falloff.
As we have communicated before we're still evaluating 52 milligrams per meter squared and the data will not be complete you know from time to be disclosed in the S.G.O. prison T. should.
Anna Protopapas: We continue to see activity and plan to show further confirmed responses and prolong stability. As you will appreciate, activity is impacted by dose, line of therapy, and degree of NAPI-2B expression, as measured by age score. While we will be able to share preliminary data showing dose, age score, and activity, the number of patients in each subgroup is limited, and it will be premature to establish a cutoff for patient selection. We are excited to be presenting this data at SGO, the first of three XMT 1536 data disclosures we're planning in 2020. The oral presentation will be held on March 30th in the late-breaking session that is scheduled from 2.30 to 3.30 Eastern Time.
We continue to see activity and plan to show for the confirmed responses and prolonged stable disease.
If you will appreciate activities impacted by dose light of therapy, a degree of stopping to be expression as measured by age score.
I will be able to ship preliminary data showing goes hcareers activity. The number of patients in each sub group is limited and it will be premature to stopping to should cut for patient selection.
We are excited to be presenting this data. They go the first three except P. 50, 36 data disclosures were planning in 2020, the oral presentation will be head count on March 30 years in the late breaking session, but the scheduled for 232, three so deep Easter.
Time, we're planning to host the life conference call at West Coast. After the market close is let's see date, we will provide further information with the dial into the webcast details as we get closer to the date.
Anna Protopapas: We're planning to host a live conference call and webcast after the market closes that same day. We will provide further information with a dial-in number for the webcast details as we get closer to the date. Now moving on to the expansion cohorts, we are on track in our recruitment, and the protocol amendment to move the dose to 43 mg per m2 is rapidly being adopted. Although the patients in the expansion cohorts are still late stage, they are more homogeneous than those in the dose escalation study. Our objective for the expansion cohort is to establish proof of concept, including response rate, duration, and a NAPI-2B expression cutoff in the patient population where we will seek to run a pivotal study. For ovarian cancer, the standard of care in this setting is single-agent chemotherapy, and multiple contemporary studies have defined the performance of this standard of care as 4 to 12 percent response rate and 3 to 4 months of PFS.
Now moving on to the expansion cohorts. We're on track you know recruitment is the protocol amendment to move this dose to 43 milligrams per meter squared is rapidly being adopted although the patients of the expansion cohorts are still late stage. There are more homogeneous that those should the dose escalation study.
Our objective for the expansion cohorts used to establish proof of concept, including response rate duration, and then not be to be expression.
In the patient population, where we will seek to run a pivotal study.
You know very intensive standard of care in this setting single agent chemotherapy and multiple contemporary studies. So do you find the performance of the standard of care is 4% to 12% response rate in three to four buts PFS.
Anna Protopapas: Within ovarian cancer, we believe we have a faster market path using a single-arm registration study if we can show a response rate above the historical standard of care. In non-small cell lung cancer, the standard of care following progression of checkpoint inhibitors and platinum-based chemotherapy or failure of targeted therapy for patients with tumors harboring opogenic driver mutations is docetaxel alone or in combination with targeted agents. This standard of care has an overall response rate of 14 to 23 percent and a median progression-free survival of three to four months. There are fewer precedents for faster market paths in non-small cell lung cancer, but we continue to evaluate options. The correlation of NAPI-2B expression with EGFR and KRAS mutations, as we reported at the TRIPLE meeting in 2019, raises intriguing possibilities for further patient selection in this high unmet medical need population. The collection of both archival and fresh tissue in the expansion phase will allow us to better define the patient selection strategy overall.
Within ovarian cancer, we believe we have a softer market huh using a single a registration study who could show a response read about the historical standards of care.
In non small cell lung cancer, the standard of care following progression checkpoint inhibitors of platinum based chemotherapy.
I will say do targeted therapy for patients with tumors harboring, we'll put Jedi drugs.
Teaches you still should talk so alone or in combination with targeted agents. This standard of care and overall response rate of 14% to 23% median progression free survival three to four months.
There are fewer precedence for foster market Pops in non small cell lung cancer, but we continue to evaluate options the correlation of not be to be expression. We did your flooring U.S. mutations as we reported that the triple meeting in 2019, raising tweaking possibilities for further patient selection.
Should it be high unmet medical need population.
Collection for booty archival and fresh tissue it'd be expansion phase will allow us to better defined the patient selection strategy overall.
Anna Protopapas: Our next disclosure after SGO will be interim dose expansion data in the second quarter. The second disclosure will provide an early look at the data from the expansion cohorts, including more information on safety and efficacy as well as on the potential patient selection strategy. In the second half of the year, we plan to provide more mature data from the expansion core.
Our next disclosure after if if you will be intrude dose expense should be done in the second quarter. The second disclosure will provide an early look at the data from the expansion cohorts, including more information on safety and efficacy as well as of the potential patient selection strategy.
In the second half of the year, we plan to provide more mature data from the expansion pool.
Anna Protopapas: We're very pleased with the progress made to date in advancing XMT 1536 towards proof of concept and look forward to presenting this progress at SGO and throughout the year. I will now turn to our second clinical candidate, XMT-1592, which we disclosed in January. XMT-1592 was developed using our new platform, DolaSynthin. DolaSynthin retains a proprietary or a static dollar log payload with controlled bystander effect but is designed to have the added benefits of site-specific conjugation, precise drug-to-antibody ratio, and even greater hydrophilicity for further enhanced drug-like properties and tumor exposure.
We're very pleased with the proper speak to date in advancing exemplary 15 36 towards proof of concept and look forward to presenting this progress this year, it's wants to hear.
I will now turn to our second clinical candidate, except P 59, p. to which we disclosed January.
Exome P. 50, 92 was developed using a new platform. So lets since it does seem to do we take so proprietary aura study dolev payloads, we control bystander effect, but these design to have the added benefits of site specific conjugation.
Precise stroked want to put the ratio and even greater hydrophylicity for further enhance drug like properties and schuler exposure, we have chosen happy to be as a first target for except P 52.
Anna Protopapas: We have chosen NAPI to be our first target for XMT-1592 based on the following. First, preclinically, XMT-1592 has shown a differentiated profile, particularly non-small cell lung cancer, where we saw a four-fold increase in efficacy over 1536 in models of lung cancer, consistent with higher tumor penetration. If validated clinically, this can provide us with an important second shot at goal in lung cancer, a very large indication with significant unmet medical needs. Second, we can achieve clinical validation of XMT-1592 and the Dollar-Simpson platform efficiently, given our leadership in NAPI 2B, our understanding of the patient population, our relationships with investigators, and the commonalities between the two molecules. Both the antibody and the dollar-log payload are being manufactured at commercial scale. This validation will also help us to decide which platform is ideal for a given target when selecting future pipeline candidates. Lastly, we believe NAPI2P is an ideal target for our ADC platforms, and we are in a first-in-class position with 1536, where we are already seeing encouraging safety, tolerability, and activity. With 1592, we have the potential to further extend our leadership position.
So the following.
Preclinically exit P. 50, 92 has showed a differentiated profile, particularly non small cell lung cancer, where we saw a fourfold increase it efficacy over 15, so de CIX in models for lung cancer consisted with higher Chubut penetration.
Validated clinically this could provide us an important second shot on goal in lung cancer.
Very large indication significant unmet medical need.
Second we can achieve clinical validation of X P 50, 92, and the dollar since platform appreciably, given our leadership in happy to be or understanding of the patient population our relationships with investigators and the commonalities between the two molecules both young people would be.
The dollar Bill pay nodes are being manufactured a commercial scale. This validation will also help us to decide which platform is ideal for a given target when selecting future pipeline candidates.
Lastly, we believe not be two pieces ideal target for our APC platforms and where in the first in cost position 15, 36, where we're already seeing encouraging safety Tolerability of activity was 50 92, we have the potential to further extend our leadership position.
We are would try to initiate phase one dose escalation study of exit P. 50, 92 in the first half of 2020. Additionally, we plan to present further except P. 50, 92 preclinical data at the upcoming Ace Yara April stay.
Anna Protopapas: We are on track to initiate phase one dose escalation study of XMT 1592 in the first half of 2020. Additionally, we plan to present further XMT 1592 preclinical data at the upcoming AACR annual meeting in April. Stay tuned for more specifics of this disclosure as we get closer to the meeting.
A twod for more specifics of this disclosure as we get closer to the meeting.
We're continuing to advance our first in class B seven each for a B C. As we have described this is a great D.C. target well suited for the unique characteristics of what Dolittle payloads and platforms and the good fit for us strategy focusing on potential funds to market opportunities.
Anna Protopapas: We're continuing to advance our first-in-class B7H4 ADC. As we have described, this is a great ADC target, well-suited for the unique characteristics of our dollar-locked payload and platforms, and a good fit for our strategy of focusing on potential faster market opportunities. We have compelling preclinical efficacy and non-human primate tolerability data with both dolaflexin and dolacintin ADCs targeting B7H4, and we expect to disclose our development candidate and the supporting data in the second half of the year. Finally, we're continuing to advance our Immunosynthin Discovery Pipeline. We have a robust set of efficacy and tolerability data across multiple targets. The potential of activating the innate immune system to fight cancer in a safe and targeted manner is a potential game changer.
Yeah.
Preclinical efficacy and non human primate Tolerability data with both still a flexing into let's sit today Pcs targeting vseven each for and weak split to disclose or do Bowman did it supporting data in the second half.
Finally, we're putting into advisory since a discovery pipeline has a robust efficacy and tolerability data across multiple targets the potential of activating being named immune system to fight cancer in a safe and targeted manner is the potential game changer.
Anna Protopapas: We're on track to finalize the Immunosynthin platform design and target prioritization and select our first Sting Agonist ADC development candidate in the second half of 2020. We're excited about the potential of this platform and are planning to disclose further preclinical data from this work at an upcoming AACR annual meeting in April. In closing, we have a busy but exciting year ahead of us with multiple opportunities to build value. We have a lead asset nearing proof of concept, a growing first-in-class pipeline of ADC candidates designed to address significant unmet medical needs for cancer patients, and innovative and differentiated platforms that will allow us to efficiently generate a robust pipeline of ADCs for multiple targets. And as before without time, we have the financial resources to execute on this plan. We are excited for the year ahead and look forward to updating you as we progress on each of these fronts. And with that, I will turn the call over to Brian DeSchuytner, Mersana's Senior Vice President of Finance and Product Strategy, for an overview of our financial results.
Were on track to finalize the municipals plucked from design and targeted prioritization and select first stick I couldn't be CTC development candidate <unk> second half of 2020 were excited for the potential of this platform planning to disclose further preclinical data from this work.
It's about becoming easier I don't meeting in April.
In closing, we have a busy but exciting year ahead of us with multiple opportunities to build side you. We heavily dossett nearing proof of concept a growing first in class pipeline, a D.C. candidates designed to address significant unmet medical needs for cancer patients and innovate.
Even differentiated platforms that would allow us to officially generate a robust pipeline of 86 for multiple targets.
And it's Brian without.
We have the financial resources to execute on this plan.
We are excited for the hearing that and look forward to updating you as we progress on each of these fronts and with that I would turn the call over to Brian <unk>, which saw the senior Vice President Finance and product strategy for an overview, we're afraid actual results.
Brian C. DeSchuytner: Thank you, Anna. Good morning, everyone, and thank you for joining us today.
Thank you Ana good morning, everyone and thank you for joining us today today I'll review some of the key financial highlights from our fourth quarter 2019 results I'll start with our cash position. We ended the fourth quarter 2019, with approximately 100 million in cash cash equivalents and marketable securities. We use net cash of two.
Brian C. DeSchuytner: Today, I'll review some of the key financial highlights from our fourth quarter 2019 results. I'll start with our cash position. We ended the fourth quarter of 2019 with approximately $100 million in cash, cash equivalents, and marketable securities. We used net cash of $12.6 million in operations in the fourth quarter of 2019. The company expects that its cash equivalents and marketable securities will enable it to fund its operating plan through important milestones, including the XMT-1536 Phase I clinical study and the planned dose escalation study for XMT-1592. In addition, we have the option to draw additional funds of up to $15 million through the existing debt financing agreement with Silicon Valley Bank.
Oh point $6 million and operation and fourth quarter of 2019.
The company expects that its cash cash equivalents in marketable securities will enable it to fund its operating plan through important milestones, including the ex empty 15, 36 phase one clinical study and the planned dose escalation study for X.M.T. 15 92.
In addition, we have the option to draw additional funds of up to $15 million through the existing debt financing agreement with Silicon Valley Bank.
Brian C. DeSchuytner: And now some of the key highlights from our fourth quarter 2019 financial results. Collaboration revenue in the fourth quarter of 2019 was immaterial when compared to the $1.2 million for the same period in 2018. The decrease in collaboration revenue was primarily a result of a decrease in services performed in supportive partners programs. Research and development expenses for the fourth quarter of 2019 were approximately $12.4 million, compared to $19.8 million for the same period in 2018. This was driven primarily by a decrease in manufacturing costs due to the timing of manufacturing runs and offset by an increase in preclinical efforts associated with XMT 1592 and the advancement of companion diagnostics development efforts for the NAPI 2B biomarker.
And now some of the key highlights from our fourth quarter 2019 financial results collaboration revenue in the fourth quarter of 2019 was immaterial when compared to the $1.2 billion for the same period in 2018.
The decrease in collaboration revenue was primarily result of a decrease in services performed in support of partners programs.
Research and development expenses for the fourth quarter 2019 were approximately 12.4 million compared to 19.8 million. So the same period. In 2018. This was driven primarily by a decrease in manufacturing costs due the timing of manufacturing runs and offset by an increase in preclinical efforts assays.
I see it with ex Ante 50, 92, and the advancement of companion diagnostics development efforts for the nappy to be biomarker.
Brian C. DeSchuytner: General and administrative expenses for the fourth quarter of 2019 remained flat at $4.2 million compared to the same period in 2018. The net loss for the fourth quarter of 2019 was $16.2 million, or $0.34 per share, compared to a net loss of $22.4 million, or $0.97 per share, for the same period in 2018. Weighted average common shares outstanding for the quarters ended December 31, 2019 and December 31, 2018 were approximately $48 million and $23 million, respectively. We ended the year with 45 million shares outstanding following execution of the Warrant Exchange Agreement with BVF. Approximately 2.6 exchange warrant shares are considered outstanding for the net loss per share calculation as they are exercisable at any time into common shares.
General and administrative expenses for the fourth quarter 2019 remained flat at $4.2 million compared to the same period in 2018.
Net loss for the fourth quarter of 29 team was 16.2 million or 34 cents per share compared to a net loss of 22.4 million or 97 cents per share for the same period in 2018.
Weighted average common shares outstanding for the quarters ended December 31, 29 team and Decemberthirty. One 2018 were approximately 48 million in 23 million respectively.
We ended the year with 45 million shares outstanding falling execution of the warrant exchange agreement with BVF approximately 2.6 exchange Werent shares are considered outstanding for the net loss per share calculation as they are exercisable at any time into common shares.
Unnamed: I will now turn the call back to Anne.
I will now turn call back to as.
Unnamed: Operator, we can now open up the line for Q&A.
Operator, we can now open up the line for Q Wednesday.
Unnamed: Ladies and gentlemen, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. In the interest of time, we ask that you please limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. Our first question comes from Jonathan Chang with SVB Leering. Your line is now open.
Ladies and gentlemen to ask a question you will need to press star one on your telephone.
To withdraw your question press the pound key any interest of time, we ask that you. Please limit yourself to one question and one follow up.
Standby, while we compile the <unk> roster.
Our first question comes from Jonathan Chang.
Your line is now.
Good morning, Thanks for taking my questions.
Jonathan Chang: Good morning. Thanks for taking my questions. First question, for the upcoming SGO presentation, how should we be thinking about how much NAPI 2B biomarker data will be available?
First question for the upcoming SGL presentation, or how should we be thinking about how much snappy to be biomarker data will be available.
Oh, Thank you Jonathan and good morning, we are in the dose escalation study we are collecting archival tissue, it's not a requirement, but we are requesting archival tissue. We have most of the patients, but not all of the patients there.
Unnamed: Thank you, Jonathan, and good morning. We are in the dose escalation study. We are collecting archival tissue. It's not a requirement, but we are requesting archival tissue. We have most of the patients, but not all of the patients. There are some gaps in the data set, either because we have not been able to identify a sample or because the sample provided to us is not of the quality where the age score can be read. However, for the majority of the patients, we do have an age score.
Our some gaps.
In that in the a in a in the dataset.
Either because we have not been able to identify.
Samples or because the sample provided for up to US is not of the quality will be a score can be read however, the majority of the patients we do have a in each score.
Got it thank you and second question.
Jonathan Chang: Got it. Thank you.
Unnamed: And second question, any color on how the 52 mg dose escalation cohort is going?
Any color on how the 50 to make dose escalation cohort is going.
Jonathan Chang: It's too early to tell, Jonathan, and it will not be included in the SGO presentation, but once we have all the data and have made an assessment of the dose escalation, we will seek to find the appropriate forum to share that information.
It's too early to tell Jonathan and it will not be included in the S. Geo presentation, but once we have all the Dayton have beaten assessment on the dose escalation, we will seek to find the appropriate for them to share that information.
Got it and just one last one how should we be thinking about how much and how much or the dose.
Unnamed: Got it. And just one last one. How should we be thinking about how much and how mature the dose expansion data will be in the second quarter?
Dose expansion data on the second quarter will be.
Yeah. We are we're quite encouraged with the pace of recruitment of patients.
Jonathan Chang: Yeah, we are quite encouraged with the pace of recruitment of patients, but we have not given guidance on how many patients and for how long they've been on the trial. We will seek to give more specific guidance once we have confirmed the forum for the presentation and once we are closer to the time of the presentation.
And but we have not Cuban.
Got it cadence on how many patients and for how long they've been on the trial, we will seek to give more specific guidance, which will confirm the forum for the presentation and once we are closer to the time of the presentation.
Got it thank you very much.
Unnamed: Got it. Thank you very much.
Thank you. Our next question comes from Boris Peaker with Cowen Your line is now.
Boris Peaker: Thank you. Our next question comes from Boris Peaker with Callan. Your line is now open.
Hi, good morning.
Boris Peaker: Good morning. I'd like to start with lung cancer. So for the 11 lung cancer patients to be presented at SGO, do you have a sense of how their NAPI-2b expression maybe compares to ovarian cancer if we just try to compare across different tumor types? Yeah.
Maybe start with a lung cancer. So for the 11 lung cancer patients were presented at S.G.. How do you have a sense of how they're nappy to be expression, maybe compare to the ovarian cancer. If we're just trying to compare across different tumor types.
Well I'll before first of all I'll I'll point, you to the Triple meeting presentation, we had where we did an extensive analysis will be expression of nappy to be in lung cancer patients. They do have the lung cancer patients that have I didn't know cost.
Unnamed: Well, before, first of all, I'll point you to the triple meeting presentation we had where we did an extensive analysis of the expression of NAPI2B in lung cancer patients. They do have, lung cancer patients that have adenocarcinoma do have a broad expression level, and the 11 patients we have fall within that broad expression range.
No, but do have a broad expression level and 11 patients we have a fall within that brought expression a range.
Boris Peaker: Gotcha. And just my last question is, I'm just curious, how do you anticipate the response and the durability of response from the expansion cohorts to compare to those that we'll be seeing from the dose-ranging cohorts in both ovarian and lung cancer? I'm just curious if there's any reason to anticipate them to be better or based on patient enrollment or any other characteristics.
Gotcha.
And just my last question is I'm just curious how do you anticipate their response on the durability of response from the expansion cohorts to compare to those that we'll be seeing from the dose ranging cohorts about the varying in lung cancer I'm. Just curious if there's any reason to anticipate them to be a better or based on patient enrollment or any other characteristic.
So the question is how how is the population in the dose expansion different that population in the dose escalation Boris is that the question, yeah, and how that will translate to response, yeah, maybe I'll ask Brian to answer that question.
Unnamed: So the question is, how is the population in the dose expansion different than the population in the dose escalation? Boris, is that the question?
Boris Peaker: Yeah, and how that will translate to response.
Brian C. DeSchuytner: Maybe I'll ask Brian to answer that question. Yeah, I
Brian C. DeSchuytner: Yeah, I think it's an important question because the patients in that dose escalation component of the study are very heavily pretreated and have a very poor prognosis, so they've not only progressed on the available therapies but on investigational therapies. They have a median of five prior lines, as we reported at ASCO. Multiple published studies demonstrate the poor prognosis of these patients and, frankly, their rapidly deteriorating likelihood of response with increasing lines of therapy. By the fourth and fifth lines, the response rate is near zero.
Yeah, I think it's it's an important question because the patients in that dose escalation component of study are very heavily pretreated and have very poor prognosis.
So they not only progress on the available therapies, but on investigational therapies.
Im sort of media and a five prior lines as we reported that at ASCO and.
Multiple published studies demonstrate the poor prognosis obese patients in there and frankly, there rapidly deteriorating likelihood of response with increasing lines of therapy by by fourth and fifth line.
You know the response rates near zero.
Brian C. DeSchuytner: So to answer your question about the dose expansion, that's still a late-stage patient population with a high unmet need, but they're more homogeneous in terms of line of therapy. We're recruiting a population of one to three prior platinum-resistant patients. I think you're aware and can appreciate the standard of care in that population is pretty well established. It's Doxil, Topatican, and other single agent chem
So to answer your question, but the dose expansion that's still a late stage patient population with a with a high unmet need but they're more homogeneous in terms of line of therapy.
That we're recruiting a population of one to three prior platinum resistant.
I will also take for prior therapies, regardless of platinum status.
Yeah, I think you're aware and can appreciate the a center carrying that populations pretty well established its doxil until beauty can and other single agent chemotherapy.
Brian C. DeSchuytner: The response rate of those therapies in that setting is somewhere between 4 and 12 percent with a medium 3 to 4 month PFS. We will look for improvements here. It's quite difficult to extrapolate, though, from a median five-line, prior-line patient population to a one- to three-prior-line population, because you're asking to extrapolate two to four lines earlier. So we are going to generate the data to demonstrate that over the course of 20
The response rate of those therapies in that setting is somewhere between four and 12% with a medium three to four month PFS.
We will look for improvements here, it's it's quite difficult to us to extrapolate, though from a median five line of prior line patient population to a one to three prior life population, you're asking their extrapolate two to four lines earlier.
So we are going to generate the data demonstrate that over the course of 20 Twond.
Boris Peaker: Great, thank you very much for taking my questions.
Great. Thanks, very much for taking my questions.
Thank you our next question comes on.
Debjit Chatopadhyay: Thank you. Our next question comes from Debjit Chatopadhyay, with HC Wainwright. Your line is now open.
Sure I apologize.
Your line is no.
Debjit Chatopadhyay: Hey, good morning. Thanks for taking my questions. So, a couple of clarifications. How much of the new data was included at the time of the SGO abstract submission versus what was presented at ASCO? And has the data cutoff for the SGO presentation already happened?
Hey, good morning.
Thanks for taking my questions. So couple of clarifications, how much of the new data was included at the time of the as chief abstract submission versus what was presented at ASCO and has the data cut off for the S.G. a presentation already happened.
Unnamed: Thank you for that question. There were 37 patients included, and this included at the time of ASCO, and that was not just ovarian and lung. If you remember, we had some other patients in the lower doses. So we're now close to 60, which are the new patients, on 30, 36, and 43. The cutoff for SGO has already happened, and in fact, we have already had to submit the presentation, which is why we are not in a position to include any data on 52 mg per m2.
Yeah. Thank you for that question. There were 37 patients included in this included at the time of Vasco and that was not just so burying in lung. If you remember we had some other oh some other patients in the lower doses. So we're now close to six.
The which are the new patients on 30, 36 and 43.
The conference for as steel has already happened we in fact, we already had to submit.
The presentation.
Which is why we are we're not in a position to include any data 52.
<unk> milligrams per week split.
Debjit Chatopadhyay: Thanks for that. And any plans to dose-escalate beyond 52, even if it is safe, although, you know, activity remains to be defined? Given what you have available so far.
Thanks for that and any plans to do us escalated beyond 52, even if it is safe.
Although you know activity remains to be defined.
Given what you have available so far yeah. It's a good question and I think the answer is the data will tell us where we should go.
Unnamed: Yeah, it's a good question, and I think the answer is that the data will tell us where we should go. The protocol allows us to continue to escalate until we hit the criteria for how, you know, with two DLTs. So we'll just let the data tell us. We, as you recall, saw a first response at 20, and we saw additional responses at 30, so we feel the expansion cohort is in a range that is efficacious, but we will continue to explore the profile of the drug as we push the dose up.
The protocol allows us to continue to escalate.
But until we hit with the criteria that could the criteria for US would have you know with two D.O. piece.
So we'll just let the data tell us we as you recall, we saw a first response a 20 was so additional responses that store d. So we feel the expansion cohort is in a range studies.
Efficacious, but we will continue to explore.
Debjit Chatopadhyay: And one last question, if I may. In terms of your second-generation product, the NAPI2-targeted product, are you developing that primarily for non-small cell lung cancer, or is that going to be both for ovarian and non-small cell lung cancer? Thank you so much for taking the questions.
The pro follows the drug as we push the dose up.
And one last question if I may.
In terms of your second generation product.
They're not be talking to product are you developing that primarily for non small cell or is that it's going to be bought for ovarian and non small cell. Thank you. So much for taking the questions.
Good question well on our strategy here is to ensure we strengthened our leadership in nappy to be we seek it's a great target we seek our platforms are very well suited for the time kit.
Unnamed: Good question. Well, our strategy here is to ensure that we strengthen our leadership in NAPI2B. We think it's a great target. We think our platforms are very well suited to the target.
Unnamed: Our plan with 1536 is to continue to move as fast as we can towards that single-arm registration trial in ovarian cancer. The lung cancer landscape, as we described on the call, I think is a little more, it's a little more complicated to think through what a single-arm registration trial would be, which gives us the opportunity during to bring forward 1592. These escalate quickly because we already know the patients, the sites, we have the diagnostics, and then decide which of those two is the best to take forward in non-small cell lung cancer. And our hope would be that we would find that subpopulation that allows us to do a single-arm registration trial, whether that's with 1536 or 1592; the data will tell us whether that is an option, but that would be our preferred option going forward.
Our plan with 15 36 is to continue to move as fast as we can towards that single arm registration trial in ovarian.
The lung cancers landscape as we described on the call I think is a little more.
It's a little more complicated to think through what the single arm registrations trial would be which gives us the opportunity during to bring for what 15 92 dose escalate quickly because we already know the patients the sites, we have the diagnostic and then decide which of those.
It's too is the best to take forward in non small cell lung cancer in our hope would be that we would find that sub population that allows us to do a single arm registration trial, whether that's with 15 36 or 50 92, the data will tell us whether that is an.
Option, but that would be a preferred option going forward.
Unnamed: So just to clarify, the 92 program, the dose escalation will enroll both ovarian and non-small cell and endometrial and stuff, right? So it's not specifically directed at any one cancer type in the escalation phase.
So just to clarify the 92 program.
The door escalation will enroll both ovarian and non small cell and and the mutual and stuff right. So it's not specifically to that does anyone cancer type in the escalation pro up face.
Unnamed: We have not disclosed what the escalation phase will be, but we will have an opportunity to do that once we start dosing patients. But we are on track to dose patients in the first half of this year. Thank you.
We have not disclose would be escalation phase will be a we will have an opportunity to do that once we you know we are.
Stopped dosing patients, but we are on track to dose patients in the first half of this year.
Debjit Chatopadhyay: Thank you and good luck!
Thank you and good luck.
Thank you. Our next question comes from Jessica.
Jessica Fye: Thank you. The next question comes from Jessica Fye with J.P. Morgan. Hey guys, good morning. Thanks for taking my question. Are you following up on, I think Deb just asked, based on the SGO cutoff, how should we think about the duration of follow-up at the higher 36 and 43 milligram doses we're going to see at SGO? And how many ovarian patients should we expect at each of those dose levels?
He Morgan your line is no.
Hey, guys. Good morning, Thanks for taking my question following up on I think it was that just question based on a SGL cut off how should we think about the duration of follow up at the higher 36, and 43 milligram doses were going to see it SGL and how many ovarian patients should we expect to each of those dose level.
So obviously this is a dose escalation. We started 30. So guys. You know we started to 43 back in the form. So I think this is the this is a study that's really going to answer the question around safety Tolerability and early signs of efficacy I think Gary.
Unnamed: So obviously, this is a dose escalation. We started 30, as you know, we started 43 back in the fall, so I think this is a study that's really going to answer the questions around safety, tolerability, and early signs of efficacy. I think our expansion cohorts, particularly our disclosure in the second half of the year, are really intended to answer the durability question in a more robust way. You will see durability data in this presentation, but the real sort of more definitive answer on durability will come with mature expansion cohort data.
Expansion cohorts, particularly our disclosure in the second half for the year is really intended to answer the Tolerability question in a more robust way you will see tolerability data in this presentation.
But the real sort of more definitive answer and your ability will come with mature expansion cohort data.
Jessica Fye: So I hope that answers your first question. The second question is how many ovarian cancer patients there are in the 36 and 43. And I'm going to ask my colleagues for some help.
So I hope that outside of your first question. The second question is how many ovarian cancer patients. There are in the 36 and 43 and I'm going to ask my colleagues for some help I think the majority there about 15 or 16 patients in those two altogether and that much.
Unnamed: I think the majority, there are about 15 or 16 patients in those two altogether, and the majority are ovarian, but I don't have the exact numbers in front of me at this point.
Jewelry diesel barrier, but I don't have the exact numbers in front of the at this point.
Okay, Great should we expect some data from patients at the 43 milligram dose at the time of the interim expansion update in to Q.
Jessica Fye: Okay, great. Should we expect any data from patients at the 43 mg dose at the time of the interim expansion update in 2Q?
We have we are rapidly switch most sites over to 43. There are still a few that are taking longer to adopt the amendment, but there will be some 43 patients in our second quarter disclosure.
Unnamed: We have, we have rapidly switched most sites over to 43. There are still a few that are taking longer to adopt the amendment, but there will be some 43 patients in our second quarter disclosure. The majority will be 36, but we will have some 43 patients.
The majority will be 36, but we will have some 43 patients.
Okay, and if I guess, one more I'm sure bigger picture development question I guess.
Jessica Fye: Okay, and if I can just ask one more, just a bigger picture development question, I guess, thinking about how you're going to establish a potential threshold for NAPI 2b expression that you can enrich for in future studies. I guess how many, assuming that's an efficacy call, how many sort of non-salvage line ovarian patients with valuable age scores do you expect to need to establish that cutoff?
I'm thinking about how you're going to establish a central threshold for now be to be expression that you can enrich foreign future studies.
I guess how many.
It's still assuming that's an efficacy call how many sort of non salvage wine ovarian patients with a valuable each scores do you expect to needs to establish that cut off.
Yeah, well weve designed to be expansion cohort in a manner that we believe is sufficiently large to give us that answer and if you recall, we did say back in the fall that we will have at least 45 patients.
Unnamed: Yeah. Well, we've designed the expansion cohort in a manner that we believe is sufficiently large to give us that answer. And if you recall, we did say back in the fall that we would have at least 45 patients.
Yeah.
Great. Thank you.
Jessica Fye: Great, thank you.
Unnamed: In each of the cohorts, of course, 45 for ovarian and 45 for lung. As we learn more about the age score, we might choose to enrich along the way through a simple amendment, but our preliminary estimate was that 45 should give us sufficient data to determine what the right cut is.
Each of the cohorts of course.
45 for ovarian and 45 floor.
Huh.
We might as we learn more about the a school we might choose to enrich along the way us through a simple amendment, but our preliminary estimates was that 45 should give us.
Sufficient data to determine what the right cut office.
Michael Werner Schmidt: Got it, thank you. Thank you. As a reminder, ladies and gentlemen, that's Star, then one to ask a question. Our next question comes from Mike Oles, and your line is now open.
Got it thank you.
Thank you as a reminder, ladies and gentleman that star doesn't want to ask a question.
Our next question comes from Mike Olson with Baird. Your line is now.
Unnamed: Hey guys, thanks for taking the question. Just for XMT 1536, you mentioned a potential fast market strategy, I think in ovarian cancer, so maybe you can give a little bit more detail on how you're thinking about the potential design there, and would that be in a selected population? And then, secondly, I know this may be challenging to answer, but could you potentially be in that study by the end of the year? Thanks.
Hey, guys.
Thanks for taking the question.
Just for Exome T 15 36.
You mentioned a potential fast to market strategy I think in ovarian. So maybe you can give a little bit more detail on on how you're thinking about the potential design, there and would that be in a selected population.
And then secondly.
I know this maybe challenging the answer but could you potentially be.
In that study by the end of the year. Thanks.
Yeah, So our objective.
Michael Werner Schmidt: So our objective in executing the expansion cohort is to generate a robust set of data that would allow us to go to the FDA at the end of this year or beginning of next year and really have a meaningful discussion about the path to approval. Precedent and also feedback we've received from the investigators we're working with, and these are investigators that have worked closely with the FDA, is that because of the high unmet medical need, there is a path to approval with a single-arm registration in patients that have been treated with platinum, with avastin, and, if BRCA positive, with PARP inhibitors. And as Brian mentioned earlier, the standard of care in these patients is doxil and topotecan, and they really have a response rate that is at best 12 percent and a PFS of three to four months.
In executing the expansion cohort is to generate a robust set of data that would allow us to go to the FDA.
At the end of this year beginning of next year and really have a meaningful discussion about the path to approval.
Accident and also feedback we've received from the investigators were working with and these are investigators that have worked closely with the FDA is that there is a pass because of the high unmet medical need there is a path to approval with a single arm registration.
In patients that have been.
Being treated with platinum with Avastin nave.
Braca positive with PARP inhibitors, and as Brian mentioned earlier.
Standard of care in these patients is a doxil topotecan and really has a response rate that out.
I think it's 12% and a PFS of three to four months.
Michael Werner Schmidt: So, and in fact, if you think about the changes in ovarian cancer over the last few months, Avastin and other targeted therapies have moved up front, and therefore, the medical need in this later stage population is even more acute. So that's how we're thinking about the next step, and we're working towards generating the data from the expansion cohort that would give us and regulators the confidence to initiate that single-arm registration. Got it. Thank you.
So and in fact, if you think about the changes in ovarian cancer over the last few months Avastin and other targeted therapies have moved upfront and therefore, they medical need in this later stage population is even more acute.
So that's how we're thinking about the next step and we're working towards generating the data from the expansion cohort that would give us and regulators the confidence to initiate that single arm registration trial.
Got it thank you.
David Matthew Nierengarten: That's it. Thank you. Our next question comes from David Nierengarten, with Webhooks Security, Carolina State University. Hey, thanks for taking my question. I only have one on 1592. I was curious if you had an idea of..., and many others.
Thank you our next question.
Gordon with Wedbush Securities. Your line is now.
Hi, Thanks for taking my question I only have one on 15 92 I was curious.
You have an idea.
How many.
David Matthew Nierengarten: And those are the kind of sub-efficacious dose cohorts you would be doing given the information from 1536 or 1522. Yeah, just, you mentioned in the past that you could start maybe at a little bit higher dose. I was just curious if you had an idea of if you'd be starting likely at an efficacious dose or, you know, one dose below that. That's just my question. Thanks.
Kind of sub so efficacious dose cohorts you'd be doing given the.
Information consisting of 36 or HM.
22.
Yes, just you mentioned that the passports you could start maybe at a little bit higher dose I was just curious if you have an idea.
Starting likely at an efficacious dose or one one dose be loved that that's just.
My question. Thanks, Yeah. So we do know a lot about the target we do know lot about.
Unnamed: Yeah, so we do know a lot about the target. We also do know a lot about the patient population. Obviously, we have the same antibody and the same payload, so that really gives us an opportunity to dose escalate quickly. And those are discussions that are part of our IND filing. And when we have, when we are ready to start dosing patients, we'll be in a position to share more of our thinking, David. But we're definitely looking at those and how we leverage what we know about this target, this patient population, and our molecule to be able to accelerate the dose escalation at sub-therapeutic doses.
The patient population, obviously, we have the same antibody in the same payload. So that really gives us an opportunity to dose escalate quickly and those are discussions that are part of our I'd be filing and when we have when we are ready to start dosing patients will be in a position too.
Share more.
Moreover, our seeking David but we're definitely looking at those on how we leverage what we know about this target this patient population and ER and our molecule to be able to accelerate the dose escalation in the sub therapeutic doses.
David Matthew Nierengarten: Okay. Thank you. Thank you. And our next question is a follow-up from Deb. Chateau Patie with H.C. Wainwright, your line is now open.
Okay. Thank you.
Thank you.
And our next question as a follow up from <unk>.
Paul.
Your line is now open.
Debjit Chatopadhyay: Hey, thanks for letting me back in. So, I just wanted to follow up on the EDGE score and the dose escalation segment. So, if you come up with a cut-off of, let's say, 100, is there a... I'm just wondering, in my internal thought process, kind of... Would your dose escalate beyond 52 for the patients with an edge score cutoff below 100 to see if you can enhance activity in that setting?
Hey, thanks willing backend.
Just wanted to follow up on the edge score and the dose escalation segment. So if you come up with a cut off of let's say 100.
Is there.
I'm just wondering in internal thought process kind of would you dose escalate to be on 50 52 to.
For the patients with an escort got off below 100 to see if you can enhance activity in that setting.
Unnamed: Those escalate for the patients below 100. Oh, look, I think all of those are ideas we are considering. We just have to let the data take us where the data takes us. We don't, it's premature to speculate at this point.
Dose escalate for the patients below 100, though look I think we all of those our ideas. We are considering we just have to let the date that takes us where the date that takes us.
We don't.
It's pretty mature.
To speculate at this point.
Debjit Chatopadhyay: Got it. Thank you.
Got it thank you.
Unnamed: At this point, we are doing the expansion cohort without selection because we really want to understand in a robust way what the cutoff is. So it is an important question we have to answer this year through the expansion cohort.
We are doing the expansion cohort without selection, because we really want to understand.
In a robust way what the cut off is so so it is an important question we have to answer this year through the expansion costs works.
Unnamed: Thank you.
Thank you.
Anna Protopapas: Thank you. I'm not showing any further questions at this time. I would now like to turn the call back over to Anna Protopapas for any closing remarks.
Thank you.
Not showing any further questions at this time I'd now like to turn the call back over to.
For any closing remarks.
I want to thank everyone for sure.
Anna Protopapas: I want to thank everyone for calling into our call. We look forward to, we have a lot in front of us, a number of milestones, and a really data-rich year, and we look forward to updating you along the way. Thanks for your support.
Calling into our call.
We look forward, we have a lot in front of us along a number of milestones and a really data rich here and we look forward to updating you along the way thanks for your support.
Unnamed: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Ladies and gentlemen, this concludes todays call. Thank you for participating you may now disconnect.
Unnamed: BF-WATCH TV 2021
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