Q4 2021 Mersana Therapeutics Inc Earnings Call
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Maisano Therapeutics fourth quarter and year end 2021 conference call and webcast will begin momentarily. Thank you for your patience and please continue to standby.
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Operator: Thank you for your patience and please continue to stand by. The Mersana Therapeutics fourth quarter and year-end 2021 conference call and webcast will begin momentarily. Thank you for your patience and please continue to stand by. [music] BF-WATCH TV 2021 BF-WATCH TV 2021 Good morning, and welcome to Mersana Therapeutics' fourth quarter and year-end 2021 conference call and webcast.
Good morning, and welcome to more solid therapeutics fourth quarter and year end 2021 conference call and webcast.
Currently all participants are in listen only mode there'll be a question answer session at the end of this call I would now like to turn the call over to James Salerno Associate director of Investor Relations. Please proceed.
Operator: There will be a question and answer session at the end of this call. I would now like to turn the call over to James Salerno, Associate Director, Investor Relations. Please proceed. Good morning.
Yeah.
James Salerno: Welcome to Mersana's fourth quarter and year-end 2021 conference call. Earlier today, we issued a press release for viewing our fourth quarter and full year financial results and business updates, which will be covered on this call. A replay of today's call will also be available on the investors and media section of our website.
Good morning, welcome to marathon at fourth quarter and year end 2021 conference call earlier today, we issued a press release, reviewing our fourth quarter and full year financial results and business updates, which.
Will be covered on this call.
A replay of today's call will also be available on the investors and media section of our website.
James Salerno: After our prepared remarks, we will open up the call for Q&A. Before we begin, I'd like to mention that our call will contain forward-looking statements within the meaning of federal securities laws, including, with respect to the company's business strategy, and the design, progression, and timing of its clinical trials, or preclinical studies, and the release of data from those studies, the ability of the single arm uplift cohort to enable registration, the development and potential of our pipeline of innovative ADC candidates, the commercial opportunity of our product candidates, expectations regarding future clinical trial results, including with respect to the timing of the commencement of future disclosures, and the sufficiency of the company's cash on hand and funds available, through its debt financing agreement with Oxford Finance and Silicon Valley Bank.
After our prepared remarks, we will open up the call for Q&A.
James Salerno: Each of these four forward-looking statements is subject to risks and uncertainties that could cause actual results to differ materially from those projected statements. These risks and uncertainties are discussed in the company's quarterly report on Form 10-Q filed on November 9, 2021, and subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov and on our website at www.mersana.com. 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.
Before we begin I'd like to mention that our call will contain forward looking statements within the meaning of securities laws <unk>.
Including with respect to the company's business strategy and the design progression and timing of clinical trials or preclinical studies and the release of data from those studies the ability of the single arm uplifts cohort to enable registration the development and potential of our pipeline of innovative ADC.
C candidates the commercial opportunity of our product candidates expectations regarding future clinical trial results, including with respect to the timing of the commencement of future disclosures and the sufficiency of the company's cash on hand and funds available.
Debt financing agreement with Oxford, Finance and Silicon Valley Bank.
Each of these forward looking statements is subject to risks and uncertainties that could cause actual results to differ materially from those projected statements.
Statements.
These risks and uncertainties are discussed in the company's quarterly report on Form 10-Q filed on November nine 2021, and subsequent filings with the Securities and Exchange Commission, which are available at Www Dot FCC Dot Gov and on our website at Www Dot verisign at dotcom, 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 with that I'll turn the call over to Ana Proto Puppis resigned as president and Chief Executive Officer.
Ana Protopappas: With that, I'll turn the call over to Ana Protopappas, Mersana's President and Chief Executive Officer. Thank you, James. Good morning, and welcome to our fourth quarter and full year 2021 Corporate and Financial Update Call. Joining me today with prepared remarks are Alvin Yang, our Chief Medical Officer, and Brian DeSchuytner, our Chief Financial Officer. I'm also joined by the rest of the executive team, who will be available for your questions.
Thank you James Good morning, and welcome to our fourth quarter and full year 2021, corporate and financial update call. Joining me today with prepared remarks are RV young our chief Medical Officer, and Brian just shy.
<unk> Financial Officer I'm also joined by the rest of the executive team, who will be available for your questions.
Ana Protopappas: At the beginning of the year, we outlined our strategy of building a leading ABC company with a focus on the opportunity to benefit patients and shareholders. That strategy consists of four pillars, building APRI into a foundational therapy in ovarian cancer, building out our pipeline of highly impactful cancer medicine, building innovation and scientific leadership in ADCs, and building Mersana with a strong financial position, top talent, and as a strategic partner of choice in the ADC space.
At the beginning of the year, we outlined our strategy of building a leading ADC company with a focus on the opportunity to benefit patients and shareholders that strategy consists of four pillars.
Building up into a foundational therapy in ovarian.
Building out the pipeline of highly.
Custom basis.
Building innovation leadership at ATC and building on that.
With a strong financial position.
And as a strategic partner of choice.
Great.
Ana Protopappas: Let me start by describing the progress we have made executing upon our first strategic goal, building APRI into a foundational medicine for patients with ovarian cancer. Uplift, UpNext, and UpGrade, the three ongoing clinical trials that, taken together, provide the roadmap for achieving this objective, all remain on track. As a reminder, Uplift is our single-arm registration trial in platinum-resistant ovarian cancer. Uplift remains on track to be fully enrolled in the third quarter, positioning Mersana for a 2023 readout and a potential BLA filing.
Let me start by describing the progress we have made executing our first strategic cold building.
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For patients with ovarian cancer.
Yes, Nick.
Great.
In clinical trials.
Together provides the roadmap for our T V.
Yes.
All remain on track.
Hi, Mike.
This is a single arm registration trial, it's not enough.
Great.
<unk> remains on track.
Enrollment in the third quarter positioning.
2023 weeks out.
Choppy of late Friday.
Ana Protopappas: Uplift provides two shots on goal, with the first being the potential for the two-thirds of the population that are nappy to be high, where we expect to see enriched outcomes, and the second shot on goal being in the overall population. Up next is our phase 3 trial of UPRI monotherapy maintenance in NAPI2P high recurrent platinum sensitive ovarian cancer.
I'm sorry to go with the potential.
Potential in there too.
Population.
Hi.
They reached outcome.
Sure.
The overall population.
Nick you got free trials I'm prepared to therapy.
That would be to be high recurrent platinum sensitive ovarian cancer.
Ana Protopappas: Up next is also on track to initiate enrollment in the second quarter of this year and has the potential to serve as a confirmatory trial in support of global registration positioning UPRI as the next novel targeted agent and the first ADC to launch in the platinum space. An upgrade is our Phase I-II Umbrella Trial, evaluating the combination of Opry with carboplatin, followed by continuation of Opry monotherapy. We anticipate disclosing interim data from the dose escalation portion of the upgrade trial in the second half of this year.
Next is also on track.
But in the second quarter of this year and has the potential to servicing confirmatory trial in support of global registration.
There shouldn't be upkeep.
Now I'll go targeted agent and the FERC.
Right.
And upgrades.
Just wanted to on Prem that trial evaluating the combination of all three with Carboplatin, followed by continuation of therapy.
Sarah we anticipate disclosing interim data from the dose escalation portion of the great trial in the second half of this year.
Ana Protopappas: This trial has the potential to generate proof-of-concept data that could impact the standard of care in platinum-sensitive disease by replacing paclitaxel with the potential to improve efficacy, tolerability, and treatment duration, and as a result, patient outcomes.
This has the potential to generate proof of concept data.
That could impact the standard of care in platinum sensitive disease.
Kaka caso with upwards with the potential to improve efficacy.
D and treatment duration.
And as a result of patients coming from.
Ana Protopappas: We believe that the early clinical data we've shared to date has demonstrated robust efficacy and a differentiated tolerability profile without the severe neutropenia, neuropathy, and ocular toxicity seen with other ADCs, giving us confidence in our ability to execute on both a successful uplift registration trial and a potentially robust commercial launch. We believe that together, the Uplift, UpNext, and UpGrade trials have the potential to generate data to enable us to bring UpGrade to the largest number of ovarian cancer patients in the most expeditious manner.
We believe that the.
Our preclinical data we shared today.
The robust efficacy.
She is a true up there.
Without the severe neutropenia.
You operate in or conduct toxicity.
Okay.
Given our current predictive ability to execute on both the successful uplift registration trial.
Technically robust commercial launch we believe that together, we uplift upticks that upgrade trials.
Potential to January .
Two a neighbor rig upgrades to the largest number of ovarian cancer patients in the most expeditious manner.
Ana Protopappas: 2022 will also prove to be a pivotal year in executing against a strategic goal of building out a pipeline of highly impactful product candidates. XMT-1660, a dolacentin ADC targeting B7H4, and XMT-2056, our first immunocintin sting agonist ADC targeting a normal epitope of HER2, are both on track to enter the clinic in mid-2022. IND-enabling studies are substantially completed for both molecules, and the emerging clinical data continue to validate our plan to advance these candidates into the clinic.
<unk> will also be a pivotal year in executing against our strategic goal of building out the pipeline of highly impactful across the country.
Okay.
It could be $66.
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Hmm.
Targeting adult epitope two are both on track to enter the clinic in mid 2022.
They believe that.
These are substantially completed for both molecules and big emerging preclinical data can you got to take out costs.
Okay.
Terrific.
Ana Protopappas: Finally, we continue to explore the dose for XMT-1592 and remain on track to make a data-driven decision in the second half of this year, incorporating learnings from APRI on the role of NAPI in non-small cell lung adenocarcinoma in the competitive environment.
Finally, we continue to explore the dose for extra 15, 92, and we remain on track to make data driven decision in the second half of this year incorporating learnings from upgrades on the road open Duffy to be non small cell lung adenocarcinoma.
Competitive environment, the excellent performance, we booked a pre.
Ana Protopappas: The excellent performance we've observed from operating ovarian cancer and the multiple investment options in our pipeline set a high internal bar for continuing to allocate capital to this program. Furthermore, with respect to the third strategic goal of building on our legacy innovation and scientific leadership in ADCs, we are pleased with the progress of our three platforms, DolaFlexi, DolaSymptom, and ImmunoSymptom, serving as capital-efficient product engines for generating new and potentially impact We have multiple early-stage discovery programs at or near development candidate states. We recently announced two new development candidates based on our Unicentum platform, XMT 2068 and XMT 2175.
No variant cancer and the multiple investment options in our pipeline set up high internal bar for continuing to allocate capital to this program.
Furthermore, with respect to the third strategic goal of building on our legacy innovation.
The leadership team.
We are pleased with the pulp crystal, but not for teleflex.
So the capital accretion Kodak.
Generating new and potentially impactful.
We have multiple early stage discovery program.
Oh, Dear development candidate stage.
We announced two new development candidates based on our.
Got it.
Ana Protopappas: We look forward to sharing more details about these two new programs and other innovations with you over the course of the year. As the data supporting all three of our ADC platforms continue to mature, strategic partnerships are emerging as a key component of our strategy for building Mersana. Large pharmaceutical companies with a significant presence in oncology have been recognizing that ADCs are a critical modality in their toolkit for pursuing novel biological parts.
Excellent.
Okay.
175, we look forward to sharing more details about these two new broker and other innovations with you.
Over the course of the two there.
As the data supporting a yoga class.
We continue to make sure strategic partnerships are emerging as a key component of our strategy.
Lifestyle.
Corporate should be done with.
With a significant presence in oncology have been recognizing that agencies are critical mortality in their toolkit.
Biological carpet.
Ana Protopappas: All three of our platforms, supported by substantial data, serve as a capital-efficient product engine that allows us to quickly and very cost-efficiently generate new development candidates for our collaborators. Note that all three of these platforms are expected to be in the clinic generating data this year. These collaborations may not only expand Mersana's external pipeline but could also bring substantial financial contribution for redeployment in our own business. To this end, earlier this month, we announced a Research Collaboration and License Agreement with Janssen Biotech, which allows them to use their sensors to discover, develop, and commercialize novel NTGs against three exclusive targets.
All three of our platforms supported by substantial data so it's capital efficient product James.
Allow us quickly.
Every cost category.
New development candidates.
Uh huh.
Note that we have.
Scott.
In the clinic generating data this year.
Corporations make don't only started.
Got it.
Pipeline, but could also bring substantial playback should we deploy.
Great.
To this end.
We announced a research collaboration and license agreement.
Yes in biotech, which allows them to use it.
Uh huh.
What does that look like commercialized Dalton.
I get it.
Target yeah.
Ana Protopappas: YAS's collaboration with Mersana followed a thorough evaluation of our preclinical and clinical data and our robust clinical scale TMP manufacturing process. This is one of the largest ever ADC collaborations of its type and includes a $40 million upfront payment, cost reimbursement, meaningful near-term milestones, the potential for more than a billion in total milestones, and mixed single-digit to low-double-digit percentage royalties on next sales of the resulting product.
Yes, just a couple.
Nation with Masada, followed a thorough evaluation of our preclinical and clinical data.
Robust clinical scale.
Fracturing Carter. This is one of the largest ever ADC collaboration with kite and includes a $40 million upfront payment costly investment meaningfully.
Does the potential for more than the.
Total milestone.
Single digit to low double digit percentage royalties.
Net sales of the resolve product.
Ana Protopappas: Finally, as Brian will outline, we're in a strong financial position and have the resources to fund our operating plan into the second half of 2020. This is a truly exciting time at Mersana, as we execute an uplift first and foremost, advance our clinical development with UpNext and UpGreat, continue to dose explore with XMT 1592, and bring our newest candidates, XMT 1660 and XMT 2056, into the clinic. We believe that this, together with our partnership opportunities, strengthen Mersana strategically, organizationally, and financially. I will now turn this over to Arvind Yain, our Chief Medical Officer. Thank you, Anna.
Finally client will outline where in the store.
They should have been.
The resources to fund our operating plan into the second half of this place.
This is a truly exciting time right now as we execute on our plate.
First and foremost.
So clinical development with up next upgrades continue to dose explore exiting 15 92, great U S currency exit 16.
60, and exit 2015.
We believe that this together with our partnership opportunities all strength.
Strategically organizationally and quite action I will now turn this over to Arvind Young our Chief Medical Officer.
Arvind Yain: We continue to make substantial progress in advancing Opry across the ovarian cancer treatment landscape through our broad development program. We have strong support from both the GOG and MGOT, both in the U.S. and in Europe. We are on track to initiate enrollment in UPnext, a randomized placebo-controlled phase 3 trial in the second quarter of this year, and continue to gather data on UpGrade, our phase 1-2 combination trial with carboplatin, and we expect to be in a position to share interim combination data in the second half of this year.
Thank you Anna we continue to make substantial progress in advancing our pre across the ovarian cancer treatment landscape through our broad development program. We have strong support from both the G. O G N N got booked in the U S and in Europe . We are on track with initiating enrollment in up next a randomized placebo controlled phase II.
While in the second quarter of this year and continue to gather data on upgrade our phase one two combination trials with carbo platinum and.
And we expect to be in a position to share interim combination data in the second half of the year.
Arvind Yain: We remained on track to complete Uplift enrollment during the third quarter and stand poised to deliver data in the first half of 2023 with the potential to support approval in platinum-resistant disease. As was outlined in our press release, we look forward to sharing our expansion cohort data at the SGO Conference Exhibit. We previously disclosed data from a June 10, 2021 data cut from almost 100 patients with ovarian cancer enrolled in the expansion cohort of the UPWE Phase I study.
We remain on track to complete uplift enrollment during the third quarter and stand poised to deliver the data in the first half of 2023 with the potential to support approval in platinum resistant disease.
As was outlined in our press release, we look forward to sharing our expansion cohort data at the <unk> Conference next month, we previously disclosed data from the June 10th 2021 data cut from almost 100 patients with ovarian cancer enrolled in the expansion cohort of the uplift phase one study of.
Arvind Yain: Analysis of that data supported our decision to select 36 mg per mL squared as the recommended phase 2 dose for uplift. The SGO presentation and poster will provide more details from that same data cut in a medical forum. Specifically, we will provide the details of an analysis that bifurcated patients that received an affected dose of 36 mg per meter squared and those that received an affected dose of 43 mg per meter squared, increasing our sample size at the lower dose.
Analysis of that data supported our decision to select 36 mixed premier squared as a recommended phase II dose for uplift.
The S. G O presentation in poster will provide more details from that same data in a medical for <unk>.
Specifically, we will provide the details of that analysis, which bifurcated patients that received an effective dose of 36 <unk> per meter squared and those that received an effective dose of 43 <unk> per meter squared increasing our sample size at the lowest dose.
Arvind Yain: This analysis reaffirms what we communicated at the September Investor event that 36 minutes per meter squared appears to have fewer grade 3 and higher adverse events, fewer adverse events in general, no high-grade pneumonitis events, and fewer discontinuations, including discontinuation before the first scan.
This analysis reaffirms, what we communicated at the September Investor is that that 36 minutes per meter squared appears to have fewer grade three and higher adverse events fewer adverse events in general.
No high grade pneumonitis events, and fewer discontinuation, including discontinuation before the first skin.
Arvind Yain: Beyond Opry, we are really excited to advance XMT-1660 and XMT-2056 into the clinic mid-year. The preclinical data generated by our research team continues to support the robust activity of these two diverse molecules. Both molecules offer the potential to address areas of high medical need, as XMT-1660 has promise in breast, endometrial, and ovarian cancer, while XMT-2056 has potential in high and low HER2-expressing tumors, including breast cancer, gastric cancer, and non-small cell lung cancer, consistent with our non-clinical data.
Beyond operating we are really excited to advance <unk> hundred 60, <unk> 2056 into the clinic in mid year.
Preclinical data generated by our research team continues to support the robust activity of these two diverse molecules both molecules offer the potential to address areas of high unmet medical need.
T 16, 60, it's promising breast endometrial and ovarian cancer, while <unk> 2056 has potential in high and low her two expressing tumors, including breast cancer gastric cancer and non small cell lung cancer consistent with our non clinical data.
Brian DeSchuytner: We are engaged with the investigator community as we finalize the Phase I designs, and we will be able to share our plans in the near term. With these two assets entering the clinic, we are in the exciting position to have all three of our platforms generating clinical data this year. With that, I will turn the call over to Brian for an overview of our financial results. Thank you, Arvind. Good morning, everyone.
We are engaged with the investigator community as we finalize the phase one designs and we won't be able to share our plans in the near term.
With these two assets entering the clinic, we are an exciting position to have all three of our platforms generating clinical data. This year with that I will turn the call over to Bryan for an overview of our financial results.
Brian DeSchuytner: And thank you for joining us. We have summarized our fourth quarter and full year financial results in the press release. And therefore, I'll only discuss key financial highlights on this call. Net cash used in operating activities in the fourth quarter was $42 million.
Thank you Aravind good morning, everyone and thank you for joining US we have summarized our fourth quarter and full year financial results in the press release, and therefore, I will only discuss chief financial highlights on this call net cash used in operating activities in the fourth quarter was $42 million actions, we have taken in the fourth quarter.
Brian DeSchuytner: Actions we took in the fourth quarter and in the first two months of 2022 have put us in a strong position to advance our pipeline through several important value-creating milestones. We ended 2021 with $178 million in cash and cash equivalents. In the first two months of 2022, we raised $40 million from Janssen and $46 million through strategic use of our ATM, with substantial participation from existing long-term investors. In October 2021, we signed a new credit facility with Oxford SVB for up to $100 million on favorable terms with no financial or liquidity covenants, and we drew down $25 million of the facility and have another $35 million available to us at our option, with the balance available upon achievement of certain pipeline and upper development miles.
And in the first two months of 2022 have put us in a strong position to advance our pipeline through several important value, creating milestones. We ended 2021 with $178 million in cash and cash equivalents in the first two months of 2022, we raised $40 million from Janssen.
And $46 million through strategic use of our ATM with substantial participation from existing long term investors.
In October 2021, we signed a new credit facility with Oxford, STB for up to $100 million unfavorable terms with no financial or liquidity covenants, and we drew down $25 million of siding and have another $35 million available to us at our option with the balance available upon achievement of certain <unk>.
<unk> and upper <unk> development milestones.
Brian DeSchuytner: Our year-end cash balance, plus the additional cash of $86 million, and the additional $35 million available from the credit facility at our option, represents a combined amount of approximately $300 billion in capital, which we expect will fund our operating plan commitment into the second half of 2023.
Our year end cash balance plus the additional cash of $86 million and the additional $35 million available from the credit facility at our option represents a combined amount of approximately $300 billion.
And capital, which we expect will fund our operating plan commitments into the second half of 2023 <unk>.
Ana Protopappas: Additionally, continuing to execute on our business development strategy will not only create strategic value but will further enable us to extend our runway with non-dilutive capital and new partnerships around potentially impactful cancer medicine. Furthermore, execution of our operating plan would provide us access to near-term milestones from the Janssen collaboration and the additional tranches from our line of credit, which together have the potential to extend our runway even further. I will now turn the call back to Anne. Thank you, Brian.
Additionally, continuing to execute on our business development strategy will not only create strategic value what will further enable us to extend our runway with non dilutive capital and new partnerships around potentially impactful cancer medicine.
Furthermore, execution of our operating plan will provide us access to near term milestones from the Janssen collaboration and the additional tranches from our line of credit, which combined have the potential to extend our runway even further.
I'll now turn the call back to Anna.
Thank you Brian .
Ana Protopappas: We have another busy year ahead of us with many important anticipated goals and milestones. As we look to the year ahead, we believe we're well-positioned to continue to deliver meaningful progress on our four strategic pillars. As we expect uplift, our single-arm registration trial to be fully enrolled during the third quarter. Next, our first phase three trial to initiate enrollment in the second quarter. Upgrade is expected to be charting the path for upbringing Upgrade in combination with other ovarian cancer therapies with interim dose escalation data to be disclosed in the second half of this year.
We have another busy year ahead of us with many important anticipated goal set milestones as we look to the year ahead. We believe we are well positioned to continue to deliver meaningful progress on our four strategic pillars as we expect uplift our single arm registration trial to be fully enrolled.
During the third quarter up next our first phase III trial to initiate enrollment in the second quarter upgrade to be charting the path for a pre copulation with other ovarian cancer therapies with interim dose escalation data to be disclosed in the second half of this year and.
Ana Protopappas: And XMT 1660 and XMT 2056 to be in the clinic in the middle of the year, and we hope to make a decision on XMT 1592 in the second half of the year. We remain focused on our goal of establishing a foundational therapy for ovarian cancer and creating value for patients and shareholders by addressing significant unmet medical needs. We believe XMT 1592, 1660, and 2056 have the potential to address substantial market opportunities and make a real impact on patients.
<unk> 16, 60 exemplary 2056.
Clearly in the middle of the year and to make a decision on exiting 15.
The second half of the year.
We remain focused on our goal of establishing a piece of foundational therapy in ovarian cancer.
It created value for patients and shareholders by addressing significant unmet medical need we believe it can.
15, 90 260.
<unk> thousand 50, <unk> have the potential of attracting substantial market opportunity and making a real impact on accretion.
Ana Protopappas: Beyond UPRI and our robust pipeline of promising ADC candidates, our technology platforms continue to serve as capital efficient product engines, providing a strong foundation in support of our partnership strategy. We are well positioned to transform Mersana into a commercial stage company with a deep pipeline of innovative molecules.
I agree and a robust pipeline of publishing a category our technology folks continue to serve as capital efficient product engine, providing a strong foundation in support of our partnership strategy.
We are well positioned to correct for most saw that into a commercial stage company with a deep pipeline of radio budgets molecules. We look forward to executing on these clients and keeping you posted on our progress as we continue to strive to create substantial value for patients and shareholders over the months.
Operator: We look forward to executing on these plans and keeping you posted on our progress as we continue to strive to create substantial value for patients and shareholders over the months and quarters ahead. If you'd like to ask a question, please press star, then one. If your question hasn't been answered and you'd like to remove yourself from the queue, press the pound key.
Headquarters.
With that I will turn the call over to the operator for Q&A.
If you'd like to ask a question. Please press Star then one if your question has been answered and you'd like to look at yourself in the queue press the pound key.
Jonathan Chang: Our first question comes from Jonathan Chang with SCV Larynx. Your line is open. Good morning, and thanks for taking my questions. First question: can you discuss how you're thinking about business development and your cash position moving forward? Yeah, Brian will take that call.
First question comes from Jonathan Chang with SBB Leerink. Your line is open.
Good morning, and thanks for taking my questions.
Brian DeSchuytner: Absolutely. So obviously, we feel like we're in a very strong capital position, and business development would serve to supplement that.
First question can you discuss how you're thinking about business development and your cash position moving forward.
Yes, Brian will take that calls sure absolutely. So obviously, we feel like we're in a very strong capital position business development, which served to supplement that and there are really three pillars to the business development strategy.
Brian DeSchuytner: And there are really three pillars to the business development strategy. The first is the cytotoxic platform. And you saw what we could do there with the Janssen deal. You know, for us, we fully scaled up our cytotoxic platforms, that means we can get from a partner antibody to an IND in a very short period of time. And that brings in non-dilutive capital. In fact, the Janssen transaction, as Anna pointed out, was the largest transaction of its type, the biggest. ADC Research Collaboration and License.
The first is the cytotoxic platforms and you saw what we can do there with the Janssen deal.
For us we fully scaled up.
Our cytotoxic platforms that means we can get from our partner antibody to an IND.
In a very short period of time and that brings in non dilutive capital in fact, the Janssen transaction and I pointed out was the largest transaction of its type the largest <unk>.
<unk> research collaboration and license the second pillar of the business development strategy is really around the immuno symptom platform and for companies that have targeted modulation of the innate immune system and their sort of strategic sweet spot. We've got a lot of interest in that platform as well and I think from a platform access.
Brian DeSchuytner: The second pillar of the business development strategy is really around the immunosynthin platform. And, you know, for companies that have targeted modulation of the innate immune system in their sort of strategic sweet spot, we've got a lot of interest in that platform as well. And I think from a platform access perspective, that might look rather similar to the Janssen deal. There are obviously six immunosynthin molecules that we've developed up to various stages.
Brian DeSchuytner: And partnerships could also be used to advance more of those molecules faster. And then the third component of the business development strategy might be around the NAPI 2B assets. There, we would be very hesitant to do a deal that would cap the upside.
Perspective that might look rather similar to the Janssen deal excuse me deal.
There are obviously shifts of unison the molecules that we've developed up to various stages.
And partnerships could also be used to advance more of those molecules faster to patients and then the third component of the business development strategy might be around the <unk> assets. There we would be very hesitant to do a deal that would cap. The upside. We think we have the financial resources to get through the next several value inflection points on our own.
Brian DeSchuytner: We think we have the financial resources to get through the next several value inflection points on our own. But we may consider transactions on a regional basis, parts of the world we wouldn't go to on our own. Like, for example, I was going to add that I think a trend we're seeing, Jonathan, is that large pharmaceutical companies in the oncology space are really showing an interest in adding ADCs as part of their, you know, toolbox, and we're finding ourselves in a good position because we've invested in innovative platforms, I got it. And just a second question, can you help with those expectations for SGO? Thank you. Arvind can take this call for questions. Thanks, Jonathan.
But we may consider transactions on a regional basis parts of the world. We wouldn't go to on our own like like Asia.
I was going to add.
The trends, we're seeing John is saying is that large pharmaceutical companies in the oncology space.
Are really showing an interest in adding adcs as part of this tool.
Tool box and we're finding ourselves in a good position because we have invested in innovative platforms, we have substantial clinical preclinical data to support it.
As Brian said of course, we also Uh huh.
<unk> scaled piece up and have a very efficient process will get going from a target two N I M D.
Yeah.
Got it and.
And just second question can you help set expectations for <unk>. Thank you.
Arvind Yain: So we're excited to be attending and presenting at SGO. What we'll be sharing are multiple posters. One is actually an expansion cohort from the ovarian data that we previously had the data cut that was shared on June 10th of last year. There, we've actually bifurcated the patients in such a way that there are essentially patients that received an actual 36 versus 43 dose, and they were reassured really in regards to our decision to move toward the 36 dose, recognizing that there were fewer grade 3 adverse events, fewer adverse events in general So, we're excited to be attending SGO and presenting this information along with some additional posts.
So arvind can take this call.
Thanks, Jonathan So we're excited to be attending and presenting at Sto, what we'll be sharing our multiple posters one is actually a.
The expansion cohort from the ovarian data that we previously had the data cut that was shared on the June 10th of last year data cut.
There what we've done is actually bifurcated Ah patients in such a way that there are.
Centrally patients that received an actual 36 versus <unk> 43 dose.
And there were reassured really in regards to our decision to move towards the 36th us recognizing that.
There were fewer grade three adverse events fewer adverse events in general with the 36.
As well as actually patients being able to treat at state through their first scan for a longer period of time.
Operator: Thanks for taking my question. Our next question comes from Boris Peaker with Cohen. Your line is open.
So we're excited to be attending Sto and presenting this information along with some additional posters.
Got it thanks for taking my questions.
Okay.
Our next question comes from Boris <unk> with Cowen Your line is open.
Boris Peaker: Good morning. I guess first, I just want a general question: for the ongoing clinical studies that you have or implant studies, is there any exposure that you have in Eastern Europe? Most of our enrollment happens in the U.S. and in Western Europe. We do not have any exposure in Ukraine.
Good morning, I guess first I just wanted a general question for you.
Clinical studies that you have planned studies is there any exposure that you have in eastern Europe .
Yeah.
We do know that most of our.
And we'll maintain.
The U S and in the World, we do not have any exposure in Ukraine.
Unknown Executive: Gotcha. Also, in terms of the OPRI expansion study that you're going to be presenting, I'm curious, based on an observed side effect profile at 36 mg and maybe even more importantly at 43 mg per meter squared, are there any potential prophylactic protocols that you think can mitigate some of the tolerability or side effects that are observed for OPRI? So, of course, we've implemented many different things within the programs to really maximize the ability for these patients to maximize their treatment on study. And that includes, obviously, from the inclusion criteria to ensure that the patients are appropriately selected for. But in addition to that, obviously, ensuring that prophylaxis is in place for potential toxicities associated with the drug.
Gotcha.
I guess also in terms of the operating expansion study that you can be presented curious based on the observed side effects profile with 36 makes it maybe even more importantly, 43 <unk> per meter square are there any potential prophylactic protocols that you think can mitigate some of the tolerability or side effects that are observed for offering.
Yeah. So of course, we've implemented many different things within the programs to really maximize the ability for these patients to maximize their treatment.
On study and that includes obviously from the inclusion criteria to ensure that the patients are appropriately selected for but in addition to that obviously ensuring that prophylaxis is in place.
For a potential toxicities associated with the drugs so across the board from the standpoint of prophylaxis monitoring and inclusion.
Arvind Yain: Across the board, from the standpoint of prophylaxis, monitoring, and inclusion, we've been addressing those elements. And I would add, Boris, that the benefit of having a hundred patients with ovarian cancer and 200 overall is that we truly understand the profile of the agent, and we understand how we could optimize that profile. Obviously, the dose adjustment is one, but the other refinements to enrollment criteria and management of patients all add to even further improving the profile.
We've been addressing that those elements.
I would add for us.
The benefit of having a 100 patients in ovarian cancer in 200 overall is that we truly understand the profile of the agent and we understand how we could optimize that profile. Obviously the dose adjustment is one but all the other <unk>.
Alignments to enrollment criteria.
Management of patients or add to EBIT further improving the profile I mean, keeping in mind that our platform doesn't have those toxicities associated with it potentially with the ADC class, including the lack of severe ocular toxicities and so so obviously you know as.
Arvind Yain: I mean, keeping in mind that our platform doesn't have those toxicities associated with it, potentially with the ADC class, including the lack of severe ocular toxicities. And so obviously, you know, as far as the type of prophylaxis or management, it certainly would differ because of the lack of these cytokines.
As far as the type of prophylaxis or management, certainly it would defer because of the lack of these type of side effects.
Operator: Got it, great. Thank you for taking my call. Our next question comes from Colleen Kusy with Baird Capital. Your line is open.
Got it great. Thank you for taking my questions.
Our next question comes from Colin <unk> with Baird Capital. Your line is open.
Okay.
Colleen Kusy: Hi, good morning. Thanks for taking our questions. So since you've implemented the changes to the enrollment criteria in the UPLIFT study, have you seen any changes in the rate of enrollment or heard any pushback from centers on the new enrollment criteria? Colleen.
Hi, good morning, Thanks for taking my questions.
Unknown Executive: The GOG, in the end, got there really excited and active in relation to participation. And so we've actually seen that there's quite a lot of engagement in relation to interest in participating and so forth. We're still guiding toward Q3 as far as the complete enrollment of the study is concerned. So I would sort of offer up that there's excitement and, you know, we remain on track in relationship to enrollment. I would also add, Colleen, and I think we mentioned it back in September, that when we shared the data and our decision to modify the dose from 43 to 36, a lot of the investigators that had treated patients said, this feels right in terms of our experience in the clinic. And that was yet another sort of endorsement that we were on the right track.
Implemented the changes to the enrollment criteria and the uplift study have you seen any changes in the rate of enrollment or heard any pushback from centers on the new enrollment criteria.
So so calling.
The T O G and then got there really excited and active in relationship to participation and so we've actually seen that there's quite a lot of engagement and relationship to interest.
Interest in participating and so forth.
We're guiding still toward the Q3 as far as the complete enrollment of the study. So so I would sort of offer up that there's excitement and we remain on track in relationship to enrollment.
I would also add could lead and I think we mentioned it that could September .
When we shared the data and our decision to modify the dose from 46% to 43% to 36, a lot of the investigators have had treated.
Patient set just feels right in terms of our experience in the in the clinic and that was yet another sort of adore estimate that we were in the right.
We've had to get the right direction.
Okay, great. Thank you that's really helpful and have you disclosed the dose you're using up next and then what the dose escalation strategy is for upgrade.
Unknown Executive: We're heading in the right direction. Okay, great, thank you, that's really helpful. And have you disclosed the dose you'll use in up next and then what the dose escalation strategy is for upgrade? So we will, when we initiate dosing, which we're on track to do in Q2, we'll be able to really disclose more details around that protocol. As for upgrade, we obviously started with the approved dose for carboplatin but, as is typical, started at a lower dose for our pre- and our dose escalating. And we are on track to have sort of an interim view of that study in the second half. Okay, that's helpful.
So we will when we initiate dose, which we are on track to doing Q2, we'll be able to really disclose more details around that protocol.
As for <unk>.
S. Four upgrade we obviously started with the approved dose type of planted but as is typical started at a lower dose for four up three eight are dose escalating and we are on track to have sort of built into it.
Our view of that study in the second half of the year.
Unknown Executive: If I can squeeze in one quick follow-up question. For the upgrade combo study, how were you using the NAFI 2B biomarker in that study? So, Carly, we're not selecting for patients.
Okay. That's helpful. And then if I can squeeze in one quick follow up for the upgrade combo study how are you using the nappy to the biomarker in that study.
So currently we're not selecting for patients. So all patients are eligible to come onto the upgrade study obviously, we will be evaluating for there not be <unk> status for the patients that come on to understand if there's a differential benefit but currently we have a <unk>.
Unknown Executive: So all patients are eligible to come on to the upgrade study. Obviously, we will be evaluating the NAPI-2B status of the patients that come on to understand if there's differential benefit, but currently, we have an intention to treat or all patients that are enrolled, regardless of NAPI-2B. Okay, great.
Operator: Thanks for taking my question. Our next question comes from Kaveri Pohlman with BCIG. Your line is open.
Intention to treat or all patients are enrolled regardless of that b to b status.
Okay, great. Thanks for taking my questions.
Our next question comes from Cavalry Pullman with PCI G. Your line is open.
Kaveri Pohlman: Good morning. Thanks for taking my question. For the UpNext Firstline Maintenance Study, this is a unique trial, and most of these patients don't really have a lot of treatment options, but could you provide any insight into what PFS you might get from the placebo arm here? Yeah, sure. Yeah, I couldn't hear you very clearly, but I think you were asking a question just in relation to the performance of the placebo arm. Yeah, so just to give you context to your point, it's a high unmet need population. These patients currently have really no treatment options available to them.
Hey, good morning, Thanks for taking my questions.
The.
The first line maintenance study.
This is a unique trial and most of these patients don't really have a lot of treatment options, but could.
Could you provide any insight into what you.
You might or you can get from the placebo arm here.
Yeah sure.
Yeah.
I couldn't hear you too clearly, but I think you were asking a question just in relationship to the performance of the placebo arm. Yes. So just to give you context on exactly to your point, it's a high unmet need population. These patients currently have really no treatment options available to them.
Unknown Executive: And so to that end, I mean, the best comparison is the available relapse. Platinum Sensitive Maintenance Settings, including NOVA and Study 19, where the placebo arms were offering progression-free survivals in the four-to-five-month range, just to give you context in relationship to the limited benefit or progression-free survival these patients will have, and keeping in mind that these studies were performed earlier, so they're actually in a less heavily pretreated population that would actually exist today as we come on to study. It did not include stable disease.
So to that end I mean, the best comparison is the available.
Relapsed.
Latin am sensitive maintenance settings, including Nova and study 19, where the placebo arms were offering progression free survival in the four to five month range just to give you a context and in relationship to the limb.
Limited benefit.
And survival or progression free survival of these patients will have and keeping in mind that these studies were performed earlier so they're actually in a less heavily pretreated population that would exist actually current day as we come on to study did not include stable disease. That's right and then certainly from the standpoint of the unmet need we've talked about previously.
Unknown Executive: That's right. And then certainly from the standpoint of the unmet need we've talked about previously, the standpoint that includes stable disease patients where there are actually no approved therapies available to them in the maintenance setting. That's helpful. Thank you. And my second question is also related to the maintenance study. You're selecting patients for NOPI-2B expressions, but the Uplift study is testing NOPI-2B low patients also. Can you elaborate on your strategy for patient selection? I mean, if the data from the Uplift study are positive for NOPI-2B low patients, could you get your label expansion without changing the UpNext study design?
Is the standpoint that includes stable disease patients, where there are actually no approved therapies available to them in the maintenance setting.
Yeah. That's helpful. Thank you and my second question is also related to the maintenance study you're selecting patients who are not be to the expression, but the uplift study is testing not b to b locations. Also can you elaborate your strategy for patient selection I mean, if you if the day.
From the uplift that you got positive we're not be to be little patients could you get your label expansion without changing the up next study design.
Unknown Executive: Yeah, so we don't want to comment, obviously, on the regulatory potential of UpNext without knowing the full context of what Uplift approval will be. But keeping in mind that Uplift could serve as a confirmatory study, in particular for the high NAPI 2B, you know, obviously, we would have further discussions with regulators just in relationship to the potential for Uplift to support a broader confirmation. That's about it, thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open.
Yeah. So we don't want to comment obviously on.
The regulatory potential off net up next without knowing the full context of what uplift approval will be.
But keeping in mind that uplift could serve as a confirmatory study in particular for the high not b to B and obviously, we would have further discussions with regulators.
Just in relationship to the potential for up next to support a broader confirmation.
Got it thank you.
Our next question comes from Jessica Fye with J P. Morgan Your line is open.
Jessica Fye: Hey, guys. Good morning. Thanks for taking my questions. The first one, just to confirm, the update at SGO in March will reflect a data cut from June 10th. Did I get that right?
Hey, guys. Good morning, Thanks for taking my questions.
First one just to confirm the update at S. G. O in March will reflect a data cut from June 10th did I get that right and if so why not a more recent data cut.
Arvind Yain: And if so, why not a more recent data cut? Yeah, so it represents the June 10th cut, and this was really an opportunity for us to actually go back and, as I was describing, bifurcate that data set, really to give more robust numbers across both the 36 and the 43 to represent what they actually received. Really, as I was describing, to reinforce the decisions that we've made in relationship to the lower dose having that improved safety profile from the standpoint of the fewer grade 3 events and for patients to be able to be treated through the first scan, as well as the lack of severe pneumonitis.
Yeah, just so so it is representing that you intend to cut and this was really an opportunity for us to actually go back and desert, describing I forget that dataset.
Really to give actually more robust numbers across both the 36% to 43.
To represent what they actually received really as I was describing to reinforce the.
Decisions that we've been we've made in relationship to the lower dose having that improved.
Safety profile from the standpoint of the fewer grade three events.
And for patients to be able to be treated through the first scan as.
As well as the lack of the severe pneumonitis and so that was the intent and relationship the U S. G. O presentation itself. The June 10th data cut as otherwise mature just from the standpoint of what we presented.
Arvind Yain: And so that was the intent in relation to the SGO presentation itself. The June 10th data cut is otherwise mature, just from the standpoint of what we've presented. So just to give you context for the SGO presentation. We will, as we completely bring down and the data completely matures on the expansion cohort, obviously publish it, but at this point, we wanted to continue to share data that gives us confidence in the selection of those. And next year, just for an upgrade, where I think we could get that interim data this year.
So just to give you context of the STL presentation.
We will as we completely breakdown the data completely my choice on the expansion cohorts we will.
Obviously publish it but at this point, we wanted to continue to share data that gives us confidence on.
The selection of dose.
Okay and next year just for upgrade whereas I think we could get that interim data. This year what are the benchmarks to keep in mind. When we see those results I think you mentioned a pretty could replace Paclitaxel carboplatin doublet. So how does carbo paclitaxel performed in this setting and then last one when you talk about a high.
Brian DeSchuytner: What are the benchmarks to keep in mind when we see those results? I think you mentioned UPRI could replace Paclitaxel in this carboplatin doublet. So how does carbopaclitaxel perform in this setting? And then lastly, when you talk about a high internal bar to advance 1592, given the competitive landscape and your other investment opportunities, what is the bar for efficacy that you want to see with that product? Do you want to take the first question?
The internal bar to advanced 15, 92, given the competitive landscape and your other investment opportunities what is the bar for efficacy that you want to see what that product.
Okay.
So do you want to take the first question Arvind Usher.
Brian DeSchuytner: Oh, sure. Okay, yeah, I mean, just, well, go ahead, Brian. I think, I mean, I have strong feelings about this. The most appropriate comparator here is the control arm of GOG-213, which was the study that added Bev to platinum-based chemotherapy compared to platinum-based chemotherapy itself. The response rate in that study, and in a similar study for lotions, was about 50%. It's worth keeping in mind, however, that that data was in the pre-Bev, pre-PARP era, and today patients are much more heavily pre-treated.
Okay, Yeah, I mean, just.
Go ahead, Brian .
I mean I have strong feelings about this.
Yeah.
But most appropriate comparator here as the control arm of <unk> $2 13.
Which was the study that added Bev to platinum based chemotherapy compared to platinum based chemotherapy itself. The response rate in that study and in a similar study promotions was about 50%.
It's worth keeping in mind, however that that data was in the pre Bev pre PARP era and.
Brian DeSchuytner: In addition, there's emerging evidence that prior PARP exposure reduces platinum responsiveness in subsequent lines, and so those are all important considerations in that. Your second question was around our decision, our benchmark for non-small cell lung cancer. I think that a response rate, as we've said in the past when we were evaluating APRI, I think a response rate of around 30 percent would be a great benchmark to address because we believe that in that situation, there are opportunities for a rapid path to the market. I think anything below that might necessitate larger combination studies, which would be a pretty substantial financial commitment to go forward.
And today patients are much more heavily pretreated.
In addition, there's emerging evidence that prior PARP exposure reduces platinum responsiveness in subsequent lines and so those are all important considerations.
In that setting.
Your second question was around our decision.
Benchmark for non small cell lung cancer, I think that a response rate as we've said in the past when we were evaluating up we think a response rate of around 30% would be a great benchmark to address because we believe that in that situation there opportunities potentially for.
<unk>.
Rapid path to the market I think anything below that by.
Necessitate larger combination studies, which would be a pretty substantial financial commitment to go forward.
Brian DeSchuytner: And I think that's how we think about the competitive landscape and our benchmarks. If there are no further questions, I'd like to turn the call back over to Ana Portapapas for any closing remarks. I'd like to thank you for listening to our call. We've had a very busy and exciting first two months of this year. And we expect to continue to execute on our plan and be able to bring you substantially more news over the next the rest of the year.
That's how we're thinking about the competitive landscape.
<unk> blocks.
Thank you.
There are no further questions I'd like to turn the call back over to Ana for the purpose for any closing remarks.
Yes.
I'd like to thank you for listening into our call. We've had a very busy and exciting first two months of this year and we expect to.
Continue to execute on our plan and be able to bring you substantially more.
News over the next the rest of the year.
Thank you.
Ana Protopappas: Thank you. This concludes the program. You may now disconnect. Everyone, have a great day. Thank you. [music]
This concludes the program and you may now disconnect everyone have a great day.
Okay.
Yes.
[music].
Yes.
Yes.
[music].
Okay.