Q4 2022 ImmunoGen Inc Earnings Call
Speaker 1: The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 11.
Unknown Executive: Good morning, and welcome to Immune's fourth quarter and four year 2022 financial operating results conference call. Today's conference is being recorded. At this time, I'd like to turn the call over to Annabelle Chan, head of Investor Relations. Please go ahead.
Speaker 2: Oh
Speaker 3: Good morning and welcome to 4th quarter and 4 year 2022 financial operating results conference call. Today's conference is being recorded at this time. I like to turn the call over to Annabelle Chan head of investor relations. Please go ahead.
Anabel Chan: Good morning, and thank you for joining today's call. Earlier today, we issued a press release that included a summary of our recent operating progress in the fourth quarter and full year 2022 financial results. This press release, the recording of this call, and an updated corporate deck can be found under the Investors and media section of our website at immunogen.com. With me today are Mark Enity, our president and CEO, Anna Birkenblit, our chief medical officer, and Renee Lintini, our interim CFO.
Anabel Chan: Michael Vaskinels, our EVP of Research, Development, and Medical Affairs, and Todd Tallarico, our interim chief commercial officer, will join us for Q&A. During today's call, we will review recent accomplishments for the business, our financial results, and highlight upcoming anticipated events. We will be making forward-looking statements based on our current expectations and beliefs. These statements are subject to risk and uncertainties, and our actual results may differ materially. Please consult the risks outlined in our press release issued this morning, in the risk factor section of our most recent annual report on Form 10K and in our other SEC filings, which are available at sec.gov and immunogen.com. With that, I'll turn the call over to Mark. Thanks, Annabelle.
Speaker 3: and Renee Lantini, our interim CFO . Michael Vasconcelos, our EDP of Research, Development, and Medical Affairs, and Todd Tallarico, our interim Chief Commercial Officer, will join us for Q&A.
Speaker 3: During today's call, we will review recent accomplishments for the business, our financial results, and highlight upcoming anticipated events. We will be making forward looking statements based on our current expectations and beliefs. These statements are subject to risks and uncertainties, and our actual results may differ materially. Please consult the risks outlined in our press release issued this morning.
Speaker 3: in the risk factors section of our most recent annual report on Form 10K, and in our other SEC filings which are available at sec.gov and immunogen.com. With that, I'll turn the call over to Mark. Thanks, Annabelle. Good morning and thank you for joining us today. 2022 was a landmark year for immunogen with significant progress on multiple fronts, highlighted by the approval and launch of Ellahear as the first and only ADC for the treatment of platinum-resistant ovarian cancer, encouraging data from our second pivotal program, PVAC.
Mark Joseph Enyedy: Good morning and thank you for joining us today. 2022 was a landmark year for immunogen with significant progress on multiple fronts, highlighted by the approval and launch of Elehir as the first and only ADC for the treatment of platinum-resistant ovarian cancer, encouraging data from our second pivotal program, PVEC, advances in our early stage programs, including reaching the recommended phase two dose for 936 and initiating phase one development with 151, rebuilding our pipeline through collaborations with Oxford Biotrubics and Biotr, and strengthening our management team with Mike Baskin-Cells in a newly creative role as Executive Vice President, research, development, and medical affairs, and Daniel Charr as General Counsel.
Speaker 3: Advances in our early stage programs, including reaching the recommended phase two dose for 936 and initiating phase one development with 151. Rebuilding our pipeline through collaborations with Oxford Biotherapeutics and Bioshin and strengthening our management team with Mike Baskin-Celz in a newly created role as Executive Vice President, Research Development and that this commission's County will have another well and important addition to a stage at which are fully continue to workppy and bum with our two Lynn Smart fungus in phase two Blazers,
Mark Joseph Enyedy: In addition, this morning, we were pleased to announce a global multi-target license and option agreement with Vertex. We are excited to partner with a leader in transformative medicines and believe this deal nicely reflects our continued innovation in the ADC space and demonstrates the value of our technology platform and related intellectual property. With the momentum generated over the last 12 months, we look forward to a number of important milestones in 2023 that will include building on the strong start to the ELEHIR launch, about which I'll have more to say in a moment, reporting data from our confirmatory Mirosol trial and submitting regulatory filings to support full approval of ELEHIR in the EU and US, sharing ORR data from the Piccolo in Platinum Sensitive Disease, completing enrollment in our pivotal BPDCN study and up to dating data from expanded frontline cohorts in AML with PEVEC and reporting top line data from the expansion cohorts with 936.
Speaker 3: in the ADC space and demonstrates the value of our technology platform and related intellectual property. With the momentum generated over the last 12 months, we look forward to a number of important milestones in 2023 that will include building on the strong start to the Ellihir launch, about which I'll have more to say in a moment.
Speaker 3: Reporting data from our confirmatory MIRASOL trial and submitting regulatory filings to support full approval of Ella here in the EU and US. Sharing ORR data from Piccolo in platinum sensitive disease. Completing enrollment in our pivotal BPDCN study and updating data from expanded frontline cohorts in AML with PVEC.
Mark Joseph Enyedy: So we're proud of what we accomplished over the last 12 months and look forward to an exciting and productive year ahead as we grow our business, drive value for shareholders, and deliver more good days for patients. So just a few qualitative updates on the Eleher launch. We are now just three months in and seeing strong performance across each of the key imperatives we set for the business. First, uptake has been broad and deep.
Speaker 3: and reporting top-line data from the expansion cohorts with 936. We're proud of what we accomplished over the last 12 months and look forward to an exciting and productive year ahead as we grow our business, drive value for shareholders, and deliver more good days for patients. Just a few qualitative updates on the Ellahear launch. Thank you to everyone who have registered.
Speaker 3: We are now just three months in and seeing strong performance across each of the key imperatives we set for the business. First, uptake has been broad and deep. As a reminder, our first patient was treated on December 1st, and we generated $2.6 million in net sales for the quarter, nearly all of which came in December . Through the end of 2022, roughly 70 percent of our orders came from non-academic settings and 75 percent of our orders from accounts with no prior Ellahear experience. For more information, visit www.aclu.org
Mark Joseph Enyedy: As a reminder, our first patient was treated on December 1st, and we generated 2.6 million in net sales for the quarter, nearly all of which came in December. Through the end of 2022, roughly 70% of our orders came from non-academic settings and 75% of our orders came from accounts with no prior Elehir experience, which is a strong indicator of the breadth and depth of adoption. In the new year, revenue growth has accelerated as we are seeing a significant percentage of accounts with repeat orders complementing new patient starts.
Mark Joseph Enyedy: Turning to testing, strong demand continues for the full R1 diagnostic through the four central labs set up in collaboration with our CDX partner Roche. In addition, we're also seeing new labs request certification to run the test in-house, which we believe is another favorable sign of physician and patient interest.
Speaker 3: identification to run the test in-house, which we believe is another favorable sign of physician and patient interest. Through the end of 2022, we estimate that roughly 1,500 tests have been performed and that volume has increased as we have moved into the first quarter. Consistent with our education efforts, we believe a significant percentage of these tests are being ordered for newly diagnosed patients.
Mark Joseph Enyedy: Through the end of 2022, we estimate that roughly 1,500 tests will have been performed, and that volume has increased as we have moved into the first quarter. Consistent with our education efforts, we believe a significant percentage of these tests are being ordered for newly diagnosed patients. While these patients are not eligible for treatment with Ella here today, this will enable oncologists to rapidly incorporate Ella here into their future treatment decisions. In addition, our tracking indicates that FR alpha positivity rates remain consistent with our clinical trial experience of between 35 and 40%.
Speaker 4: between 35 and 40%.
Speaker 3: Regarding coverage, we're again off to a fast start in terms of access with a growing number of national and regional payers, including Ella here on coverage policies aligned to our label. Recall that as of early January , 18% of Medicare and 25% of commercial lives were covered. Driven by the efforts of our access team, coverage has rapidly increased this quarter.
Mark Joseph Enyedy: Regarding coverage, we're again off to a fast start in terms of access with a growing number of national and regional payers, including Elyhir, on coverage policies aligned to our label. Recall that as of early January, 18% of Medicare and 25% of commercial lives were covered; driven by the efforts of our access team, coverage has rapidly increased this quarter. We were also pleased to see Ely Here added to the NCCN guidelines in December as both monotherapy and in combination with Bevacizumab. Finally, our customer-facing teams are highly active in terms of reach.
Speaker 3: We were also pleased to see Ellihear was added to the NCCN guidelines in December as both monotherapy and in combination with bevacizumab. Finally, our customer facing teams are highly active in terms of reach. As of the end of December , our commercial and medical teams had connected with 70% of their priority targets, with these numbers continuing to increase in the new year. Finally, our teams report that feedback from medical experts and clinicians for Ellihear has been enthusiastic, and we are leveraging these customer insights to ensure positive physician and patient experiences as we move forward. So, as you can see, we've made strong progress in the early months of launch and are excited.
Mark Joseph Enyedy: As of the end of December, our commercial and medical teams had connected with 70% of their priority targets, with these numbers continuing to increase in the new year. Finally, our teams report that feedback from medical experts and clinicians for Ely here has been enthusiastic, and we are leveraged. These customer insights to ensure positive physician and patient experiences as we move forward. So, as you can see, we've made strong progress in the early months of launch and are excited about this momentum through the rest of the year and look forward to reporting the quantitative metrics for the first quarter during our next earnings call. With that, I'll turn the call over to Anna to provide additional color on our ongoing development programs.
Speaker 3: about this momentum through the rest of the year and look forward to reporting the quantitative metrics for the first quarter during our next earnings call. With that, I'll turn the call over to Anna to provide additional color on our ongoing development programs. Anna? Thanks, Mark. We are thrilled with Ellahear's accelerated approval and excited by the early feedback we are receiving in the field from health care providers.
Speaker 5: We're pleased that data from the study, which supported accelerated approval were published in the Journal of clinical oncology in January in February , the safety and efficacy data of merge in combination with in platinum resistant ovarian cancer, which supported its inclusion in MCCM guidelines were published in gynecologic oncology. We look forward to an active year ahead, including the presentation of additional efficacy data from by sequence of treatment.
Speaker 5: as well as the final overall survival analysis at SGO later this month in Tampa. While it has taken a little bit longer than anticipated to reach the requisite number of PFS events, we will imminently reach the 330 PFS events needed to trigger the primary analysis in the confirmatory MIRRISOL trial, and we now expect to announce top-line data in the second quarter. Based on the totality of data generated with Ella here today, we are excited about the prospect of this trial demonstrating improvement over investigators' choice chemo.
Anna Berkenblit: Thanks, Mark. We are thrilled with Ellahir's accelerated approval and excited by the early feedback we are receiving in the field from health care providers. We are pleased that data from the Thorea study, which supported Ellahir's accelerated approval, were published in the Journal of Clinical Oncology in January. In February, the safety and efficacy data of MIRV in combination with Bevacizumab in platinum-resistant ovarian cancer, which supported its inclusion in MCCN guidelines, were published in Gynecologic Oncology.
Anna Berkenblit: We look forward to an active year ahead, including the presentation of additional efficacy data from Surrea by sequence of treatment, as well as the final overall survival analysis at SGO later this month in Tampa. While it has taken a little bit longer than anticipated to reach the requisite number of PFS events, we will imminently reach the 330 PFS events needed to trigger the primary analysis in the confirmatory Mirosol trial, and we now expect to announce top-line data in the second quarter.
Speaker 5: before the end of this year.
Speaker 5: As we look to position MIRV as the combination agent of choice in ovarian cancer, we are progressing 2 studies. The 1st is our phase 3 gloriosa study evaluating MIRV plus bevacizumab maintenance versus standard of care bevacizumab maintenance in the 2nd line platinum sensitive setting. With the robust data we've generated for this combination in the platinum resistance setting supporting NCCM compendia listing.
Anna Berkenblit: Based on the totality of data generated with ELA here today, we are excited about the prospect of this trial demonstrating improvement over investigators' choice chemotherapy and supporting full approval of ELAHIR in the U.S. and submission of an MAA in Europe. Now, I will now turn to the broader MERF development program, which has the potential to meaningfully expand the Elehir label. In January, we completed enrollment in Piccolo, our single-arm study of Merv Monotherapy in recurrent platinum-sensitive ovarian cancer patients with high FR alpha expression. We expect data on the primary endpoint of ORR before the end of this year. As we look to position Merv as the combination agent of choice in ovarian cancer, we are progressing two studies.
Speaker 5: We are excited to move this combination up into the platinum sensitive setting, where patients have the potential to benefit from even longer treatment duration. The second is trial 420, a single arm phase two study evaluating Mervituximab plus carboplatin, followed by Mervituximab continuation in platinum sensitive ovarian cancer patients with low, medium, and high levels of FR-alpha expression. Both trials are up and running in the US with enrollment having begun in study 420, and we are actively working on opening both studies in Europe . In parallel with the significant advances we have made on the Merv program, we are also pleased with the recent progress of PVEC in both BPD-CN and AMP.
Anna Berkenblit: The first is our Phase 3 Gloriosa study, evaluating Merv plus Bevacizumab maintenance versus standard of care beavisimab maintenance in second line platinum sensitive settings. With the robust data we've generated for this combination in the platinum resistance setting, supporting NCCN Compendia listing, we are excited to move this combination up into the platinum sensitive setting, where patients have the potential to benefit from even longer treatment duration. The second is trial 420, a single-arm phase two study evaluating Mervitoxymab plus carboplatin, followed by Mervituximab continuation in platinum-sensitive ovarian cancer patients with low, medium, and high levels of FR alpha expression.
Speaker 5: In discussion with FDA, we aligned with the primary efficacy of valuable populations will be in de novo BPD-CN patients.
Speaker 5: Enrollment in CADENSA has increased following the release of these initial data, and we expect to complete enrollment before the end of this year and report top-line data from the de novo cohort in 2024. In AML, we presented, as part of our fourth consecutive oral presentation at ASH, promising efficacy data findings from dose escalation and expansion cohorts of the 802 study.
Anna Berkenblit: Both trials are up and running in the U.S., with enrollment having begun in study 420, and we are actively working on opening both studies in Europe. In parallel with the significant advances we have made on the MIRV program, we are also pleased with recent progress of PVEVAC in both BPDCN and AML. As you may recall, we previously aligned with FDA on a pivotal frontline cohort of up to 20 patients in our Phase 2 Cadenza study as a path to full approval with CRCRC as the primary endpoint and duration of CRCRC as a key secondary endpoint.
Speaker 5: This phase 1B slash 2 study is evaluating PVEC with Venetoclax and azacytidine in patients with relapsed refractory and frontline AML. This novel triplet showed manageable safety profile and strong anti leukemia activity with an objective response rate of 45% and composite complete remission or CCR rate of 25% in our expanded relapsed refractory cohort. We observed compelling CCR rates across various relapsed refractory patients subgroups and importantly in our initial frontline cohort 50% of patients achieved a CR.
Anna Berkenblit: In an initial analysis of data from this study, we were encouraged by the activity seen in both de novo and PCHM patients, or patients with a prior or concomitant hematologic malignancy, with 11 of 13, or roughly 85% of patients achieving some form of complete response. In discussion with FDA, we aligned with the primary efficacy of this valuable population will be in de novo BPDCN patients. Enrollment in Cadenza has increased following the release of these initial data, and we expect to complete enrollment before the end of this year and report top-line data from the De Novo cohort in 2024.
Speaker 5: Based upon the encouraging results from these first 10 frontline patients enrolled, we have moved forward rapidly with gathering more data for the triplet using 14 days of the venetoclax and recently completed enrollment of this cohort. Separately, we are seeing strong recruitment in a second cohort of up to 50 frontline patients with the goal of evaluating up to 28 days of the venetoclax per cycle to optimize the duration of therapy.
Speaker 5: Tolerability and efficacy outcomes from these cohorts will guide pivotal development of the triplet in frontline AML. In addition, our recently announced clinical collaboration with Gilead will evaluate the safety and anti-leukemia activity of PVEC in combination with magrolumab, and will comprise a new cohort of up to 42 patients with relapsed refractory CD123 positive AML in the 802 study. We plan to initiate this new cohort in our ongoing 802 study later this year with complete response rate as the primary endpoint. Turning now to the rest of the pipeline, we've completed dose escalation with IMGC936, and are focused on expanding to non-small cell lung cancer as well as triple negative breast cancer.
Anna Berkenblit: In AML, we presented as part of our fourth consecutive oral presentation at Ash, promising efficacy data findings from dose escalation and expansion cohorts of the 802 study. This phase 1B slash 2 study is evaluating PVEC with Venetoclax and aesocytidein in patients with relapse refractory and frontline AML.
Anna Berkenblit: This novel triplet showed manageable safety profile and strong anti-leukemia activity with an objective response rate of 45% and composite complete remission or CCR rate of 25% in our expanded relapsed refractory cohort. We observed compelling CCR rates across various relaps refractory patients subgroups. And importantly, in our initial frontline cohort, 50% of patients achieved a CR. Based upon the encouraging results from these first 10 frontline patients enrolled, we have moved forward rapidly with gathering more data for the triplet using 14 days of Venetoclacs and recently completed enrollment in this cohort.
Anna Berkenblit: Separately, we are seeing strong recruitment in a second cohort of up to 50 frontline patients, with the goal of evaluating up to 28 days of the need for clacks per cycle to optimize the duration of therapy. Tolerability and efficacy outcomes from these cohorts will guide pivotal development of the triplet in frontline AML.
Speaker 6: and the remainder from non-cash royalty revenues. Operating expenses were $329.5 million, comprised of $213.4 million of R&D expenses, compared with $151.1 million in 2021.
Renee Lentini: In addition, our recently announced clinical collaboration with Gilead will evaluate the safety and anti-leukemia activity of PVEC in combination with Magrolumab and will comprise a new cohort of up to 42 patients with relapsed refractory CD-123 positive AML in the 802 study. We plan to initiate this new cohort in our ongoing 802 study later this year with complete response rate as the primary endpoint. Turning now to the rest of the pipeline, we've completed dose escalation with IMGC-936 and are focused on expanding to non-small cell lung cancer as well as triple negative breast cancer.
Speaker 6: and $116.1 million of SG&A expenses compared with $43.8 million in the prior year. We ended 2022 with $275.1 million in cash on the balance sheet. Turning to our financial guidance for 2023, we expect revenues, excluding product revenue from EllaHare, to be between $30 and $35 million.
Speaker 6: and operating expenses between $310 and $320 million. We expect to provide Ellahear product revenue guidance later this year. Excluding anticipated Ellahear and collaboration revenue, our level of cash and cash equivalents as of December 31, 2022 alone is not sufficient to meet our current operating plan through March 1, 2024.
Speaker 6: With the addition of forecasted Ellaher product revenue and milestone payments under existing collaboration agreements, we expect these amounts, combined with existing cash, will fund operations for more than 12 months from the date of this release, and we intend to raise additional funds through equity, debt, or other financing. With that, we'll open the call for questions. Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by. We'll come back to the Q&A roster. Our first question comes from the line of John Newman with Canaccord Genuity. Your line is now open. Can! Oh!
Renee Lentini: We look forward to sharing data from the phase one dose escalation and our initial experience with these expansion cohorts in Q2 of this year. In addition, we advanced our phase one study of IMGN151, our next generation FR Alpha targeted ADC, by dosing our first patients in January and look forward to continuing patient enrollment this year. So, great progress in 2022, and we're looking forward to an eventful 2023. With that, I'll turn the call over to Renee to cover the finances.
Speaker 3: Hi there, guys. Good morning. Thank you for taking my question. I just want to confirm on the top line data readout for MiRISOL, that will of course include the mature PFS data as expected and some information on overall survival, which I believe you previously said would be immature, but you'd follow long term. Also curious on the Ellahear launch, just wondered what you're seeing here in terms of combination use with the VASTN at the moment. Thanks. Yeah. So, John , you're right that our primary PFS analysis were imminent in terms of triggering it based on the 330 requisite events. And when we have top line data, we will share PFS data.
Renee Lentini: Thanks, Anna. For the full year 2022, we generated $108.8 million in revenue, including $76 million in license and milestone fees, $2.6 million in net product fields of Elehair, and the remainder from non-cash royalty revenue. Operating expenses were $329.5 million, comprised of $213.4 million of R&D expenses compared with $151.1 million in 2021, and $116.1 million of SG&A expenses compared with $43.8 million in the prior year.
Speaker 5: We will also share initial OS data. In terms of the level of maturity of OS data, we anticipate that there will be probably about greater than 60% of the overall survival events. So while it's not the final OS analysis, we anticipate that the OS data will indeed be mature enough, for regulators to understand the benefits.
Renee Lentini: We ended 2022 with $275.1 million in cash on the balance. Turning to our financial guidance for 2023, we expect revenues, excluding product revenue from Elehier, to be between $30 and $35 million, and operating expenses between $310 and $320 million. We expect to provide Eleher product revenue guidance later this year, excluding anticipated Elehere and collaboration revenue.
Speaker 4: data yet to really evaluate the utilization of L here as a model therapy or in combination. But as we get additional patient data, we'll probably have a better idea of that in the next quarter or so.
Unknown Executive: Our level of cash and cash equivalence as of December 31st, 2022 alone is not sufficient to meet our current operating plan through March 1st, 2024. With the addition of forecasted Eleher product revenue and milestone payments under the existing collaboration agreement, we expect these amounts, combined with existing cash, will fund operations for more than 12 months from the date of this release, and we intend to raise additional funds through equity, debt, or other sources.
Speaker 3: Great, thank you. Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is now open. Hey, guys. Thanks for taking my questions. I had one regarding the upcoming PICOLO data later this year. I'm just wondering how we should think about the regulatory bar in terms of response rate. I think in the…
Speaker 3: Platinum resistance setting, we've talked about the 12% hurdle rate for chemotherapy. Is that similar in the platinum sensitive setting for Piccolo? And then circling back to 936, I know you've talked about presenting data here in the second quarter from dose escalation, early expansion cohorts. Just wondering if you could give us some more color on the quantity of the data, how many patients are in the expansion cohorts at this point. Thanks so much. Sure. So, in terms of the regulatory bar for recurrent platinum sensitive ovarian cancer, and I would say later line patients, so with two or more priors, there is no clear bar, unlike in the platinum resistant setting where we aligned with FDA, as you pointed out on 12% based on multiple phase three trials.
Unknown Executive: But that will open the call for questions. Thank you. As a reminder, to ask a question, please press Star-1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press Star-1-1 again. Please stand by with the Q&A roster. Our first question comes from the line of John Newman with Kenne Accord Genuity. Your line is known. Hi, good morning.
Unknown Executive: Thank you for taking my question. I just want to confirm the top line data readout from your soul. That will, of course, include the mature PFS data, as expected, and some information on overall survival, which I believe you previously said would be immature, but you'd follow long term. Also curious about the Eleher launch; just wondered what you're seeing here in terms of combination use with Vast and Yeah, so John, you're right that our primary PFS analysis was imminent in terms of triggering it based on the 330 requisite events. And when we have top-line data, we will share PFS data. We will also share initial OS data.
Todd Tallarico: In terms of the level of maturity of OS data, we anticipate that there will probably be greater than 60% of overall survival events. So while it's not the final OS analysis, we anticipate that the OS data will indeed be mature enough, you know, for regulators to understand the benefit of Mervatuximab. And then, of course, we will have the final OS analysis later when we hit the requisite number of events for that. Now, I'll turn it over to Todd.
Speaker 5: And all I can say is the greater the activity of Mervituximab in the piccolo study, the easier that conversation will be.
Todd Tallarico: Yeah, thank you. John, from an evast incombination approach where you don't have the data yet to really evaluate the utilization of LHare as a monotherapy or in combination. But as we get additional patient data, we'll probably have a better idea about that in the next quarter or so. Great, thank you. Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is yellow.
Speaker 5: Moving to your 2nd question on 936, we do anticipate sharing data in Q2 on the findings from dose escalation. So, you know, we'll be able to talk about. A dose escalation, the recommended phase 2 dose and schedule a little bit of color about how we got there and then we'll be able to provide initial data on expansion cohorts in.
Speaker 5: triple negative breast cancer and non-small cell lung cancer. I think we'll be able to share sufficient data on triple negative breast cancer. We may hold off on sharing data from lung cancer, from non-small cell lung cancer because we like what we're seeing so far and we might just want to continue enrolling before we give a complete view of those data.
Anna Berkenblit: Hey guys, thanks for taking my questions. I had one regarding the upcoming Piccolo data later this year. Just wondering how we should think about the regulatory bar in terms of response rate. I think in the platinum resistance setting, you know, we've talked about the 12% hurdle rate for chemotherapy. Is that similar in the platinum sensitive setting for Piccolo?
Speaker 3: Thank you. Thank you. Our next question comes from the line of Ed, with BMO Capital Markets. Your line is now open. Great. Thanks for taking the question. One for me may be a little bit too immature, given your earlier commentary, but just wondered if you had a sense sort of the percentage of patients that are being given LAHIR pre-bevacizumab and any color on the LAHIR sort of patient experience for those patients given sort of Mirtinuximab pre-bev. And again, I think that kind of goes around sort of getting to the relative unknown, if you will, from aerosol outcome, and if you could kind of gain any incremental insights into that based on patients given that...
Anna Berkenblit: And then circling back to 936, I know you've talked about presenting data here in the second quarter from dose escalation and early expansion cohorts. Just wondering if you could give us some more color on the sort of quantity of the data, you know, how many patients are in the expansion courts at this point. Sure.
Anna Berkenblit: So in terms of the regulatory bar for recurrent platinum-sensitive ovarian cancer, and I would say later line patients, so with two or more priors, there is no clear bar, unlike in the platinum-resistant setting, where we aligned with FDA, as you pointed out, on 12% based on multiple phase three trials with investigator-choice chemotherapy. In the later line recurrent platinum sensitive setting, this is an evolving, emerging, and growing unmet need with more patients falling into this category after having had a prior PARP inhibitor as maintenance.
Speaker 4: the drug sort of pre-BEV versus pulse Venn. Let me start out there and then I'll ask Todd if he wants to add any color. So, as Todd alluded to, our best available data will come from evaluating claims data. It's very early in terms of the generation of those data from the external sources. And so, for example, while we do see MIRV-BEV use, for example, sort of trying to fix the percentage given the early days of the data inputs, I think would not be productive. Similarly, looking at the question of whether a patient has received prior BEV, again, too early to tell.
Anna Berkenblit: Recent data have shown, indeed, that PARP inhibitors may result in cross-resistance so that even if patients technically have platinum-sensitive disease, they may not be as sensitive as they were previously in the pre-PARP days, if you will. And so while there are some
Anna Berkenblit: There are studies out there that we can use, both in terms of platinum and non-platinum-based combinations, particularly in patients with BRCA mutations, which are only about 20% to 25% of patients. We have a sense of what the efficacy is, but we would really need to engage with FDA on what the bar would be. And all I can say is the greater the activity of myrvituximab in the Piccolo study, the easier that
Speaker 4: to manage events as as as we go forward. So you know, from a quantitative perspective, as I said, the data you know the claims data are just too early to give kind of definitive guidance in terms of breakdown of combo versus mono and. You know where the line of treatment is and what the prior treatments were.
Speaker 4: to manage events as we go forward. So, you know, from a quantitative perspective, as I say, the data, you know, the claims data are just too early to give kind of definitive guidance in terms of breakdown of combo versus mono and, you know, where the line of treatment is and what the prior treatments were. Got it.
Anna Berkenblit: Moving to your second question on 936, we do anticipate sharing data in Q2 on the findings from dose escalation. So, you know, we'll be able to talk about dose escalation, the recommended phase two dose and schedule, and a little bit of color about how we got there. And then we'll be able to provide initial data on expansion cohorts in triple negative breast cancer and non-small cell lung cancer. I think we'll be able to share sufficient data on triple negative breast cancer.
Speaker 4: Thank you. Our next question comes from the line of Boris Peaker with Cowen. Your line is now open. Great. Thanks for taking my questions. I want to focus on the screening for polytric heptar alpha. You mentioned earlier that about 1,500 patients were screened, and that would have been like the last month of the year. Can you comment how many patients have been screened since the time of maybe in 23? And also, you mentioned that many of the tests are being done in newly diagnosed patients. Can you mention why are doctors doing this if they really don't have a therapeutic option based on this test for newly diagnosed patients? Yeah. So what I can say about testing is that the rate has increased since the... So we basically did...
Anna Berkenblit: cancer. We may hold off on sharing data from lung cancer with non-small cell lung cancer because we like what we're seeing so far and we might just want to continue enrolling before we give a complete view of those data. Thank you. Thank you. Our next question comes from the line of Ed Serd-Dorout with BMO Capital Markets. Your line is now open.
Speaker 4: 1,500 tests in the first six weeks from approval through the end of the year, and that the testing rate has increased as we move through the first two months of 2023. We'll provide hard data when we have the next earnings call in terms of the actual quantity of the earnings come into play. For more updates, please click the link at the end of the program.
Unknown Executive: Great, thanks for taking the question. One for me, maybe a little bit too immature, given your earlier commentary, but just wondered if you had any sense.
Unknown Executive: earlier commentary, but just wondered if you had a sense of the percentage of patients that are being given LAHare pre-Bavacizumab and any color on, you know, the L.A. here sort of patient experience for those patients given sort of Mervituximab, pre-Bev. And again, I think that kind of goes around sort of getting to the relative unknown, if you will, for Marisol outcome. And if you could kind of gain any incremental insights into that based on patients given that the, the, the drug sort of works pre-bev versus post-PBub. Let me start with that, and then I'll ask Todd if he wants to add any color.
Speaker 4: of tests in terms of why does a physician want to assess FR alpha status in a newly diagnosed patient. What we see from this physician group is they've become very accustomed over the last several years, you know, initially looking for BRCA mutations and more recently for homologous recombination deficiency to really understand the genetic profile completely of the tumor. And so the adoption rates quite candidly and for newly diagnosed patients have exceeded our expectation. It is because of the way in which.
Unknown Executive: So, you know, as Todd alluded to, you know, our best available data will come from evaluating claims data. It's very early in terms of the generation of that data from external sources. And so, for example, while we do see Merv Bev use, for example, sort of trying to fix the percentage given the, you know, the early days of the data inputs, I think would not be productive.
Speaker 4: this physician base has evolved in terms of their initial workup of the patients. The other thing it does is it reduces any delay in terms of making a prescribing decision. Once they know that they've got an FR-alpha positive patient, if that patient progresses within our label, there's no need for a subsequent test. They can use the previously available data and advance the patient onto Allehere immediately. Great. Thank you very much for taking my question. Thank you. Our next question comes from the line of Andy Shea with William Blair. Your line is now open.
Unknown Executive: Similarly, you know, looking at the question of whether a patient has received prior Bev, again, too early to tell. But what I would say is the feedback that we're getting from the field anecdotally continues to be highly enthusiastic in terms of the use of the drug and managing patients on an ongoing basis. As I mentioned, we see.
Speaker 3: Great. Thanks for taking our questions. I have one about maybe potentially detecting an OS signal for Marisol. I remember the PS2 plus re-analysis was pretty provocative from 4-1. And that was a little bit over 100 patients versus 4-50 with Marisol. So just trying to understand the ability to detect that signal. Yeah, thank you, Andy. So your memory is absolutely correct. In 4-1, we had actually quite a strong trend, even in the 10X, if you will, F or Alpha High patients favoring Marva Tuxamab in overall survival. And in that...
Unknown Executive: an increasing percentage of repeat orders to complement the new patient starts, which is encouraging. And, you know, we are in very close contact with the accounts as new patient starts through, you know, ophthalmology referrals, and then any follow-up questions. You know, starting with this basic thing is infusion to manage events as we do. go forward. So, you know, from a quantitative perspective, as I say, the data, you know, the claims data are just too early to give kind of definitive guidance in terms of the breakdown of combo versus mono and, you know, where the line of treatment is and what the prior treatments were. Thank you. Our next question comes from the line of Boris Peaker with Cowan. Your line is now open. Great.
Speaker 5: PS2 plus, so the properly identified F or alpha high patients, there was a very nice signal for favoring over investigator choice chemotherapy. You're right in a relatively small subset and it was post hoc. And so all of these reasons make us confident that overall survival in Mirasol will trend strongly in favor for over chemotherapy. And my prior point that will have greater than 60% of the events. So the OS data will be relatively mature and interpretable at the time of the primary PFS analysis is important.
Unknown Executive: Thanks for taking my questions. I want to focus on the screening for Polyd receptor Alpha. You mentioned earlier that about 1,500 patients were screened, and that would have been, like, in the last month of the year. Can you comment on how many patients have been screened since then or maybe in 23? And also, you've mentioned that many of the tests are being done in newly diagnosed patients. Can you please mention why are dogs doing this if they really are?
Speaker 5: You're right, we enrolled a little over 450 patients. So the study does have reasonable power to detect a statistically significant improvement in overall survival. But we do not need that for regulatory approval either in the US or Europe . No drug in ovarian cancer has been approved based on an overall survival benefit. So as long as we see a positive trend in the right direction, we'll be fine and there is a chance we could hit statistical significance. Again, the stronger the OS data, the easier the conversations are in Europe , particularly around payers and access and the value proposition. That's very helpful.
Unknown Executive: don't have a therapeutic option based on this test for newly diagnosed patients? Yeah, so what I could say about testing is that the rate has increased since the, so we basically did 1,500 tests in the first six weeks from approval through the end of the year, and that the testing rate has increased as we've moved through the first two months of 2023, and we'll provide, you know, hard data as we, when we have the next earnings call in terms of the actual quantity of, um, of tests in terms of why does a why does a physician want to assess FR alpha status in a newly diagnosed patient?
Unknown Executive: What we see from this physician group is they've become very accustomed over the last several years, you know, initially looking for Bracket mutations and more recently for homologous recombination deficiency to really understand the genetic profile completely of the tumor. And so the adoption rates, quite candidly, and for newly diagnosed patients, have exceeded our expectations. And it is because of the way in which this physician base has evolved in terms of their initial workup of patients.
Speaker 5: for the triplet and then continues on including the triplet duration and then as well as the Avastin maintenance component. So our study, you may remember, we randomized patients at the time of maintenance. So any patient, as long as they have not progressed, will be randomized to MERV, FEV, versus VEV maintenance.
Unknown Executive: And so the other thing it does is it reduces any delay in terms of making a prescribing decision. So once they know that they've got an FR alpha positive patient, you know, if that patient progresses to, you know, within our label, there's no need for a subsequent test. They can use the previously available data and advance the patient on to Ellie here immediately.
Speaker 5: And so with that, you know, we've worked with our statisticians to do some modeling. And I think it's clear we have a very clear understanding of that that has guided the sample size and the hazard ratio, et cetera, that we've used to design the study. You know, I think we'll leave the details for that for another time. But I think the important point is that for those patients who have not progressed. You know, evasive maintenance has modest efficacy. And I think with more.
Unknown Executive: Great. Thank you very much for taking my question.
Unknown Executive: Our next question comes from the line of Andy Shea with William Blair. Your line is now open. Great, thanks for taking out the questions. I have one about maybe, potentially.
Unknown Executive: an OS signal for Marisol. I remember the PS2 plus reanalysis was pretty provocative from Forward 1, and that was over a little bit; it was a little bit over 100 patients.
Speaker 1: to be released at the Russell update. I'm just curious, you just mentioned the OS benefit will not be the basis for the full approval discussion. I'm curious in the case if the median PFS benefit is less than 1.5 months over chemo, would the regulatory agency put more weight on evaluating OS benefits? Thank you.
Unknown Executive: 100 patients versus 450 with Marisol. So just try to understand the ability to detect that Yeah, thank you, Andy. So your memory is absolutely correct.
Anna Berkenblit: In Forward 1, we actually had quite a strong trend, even in the 10x, if you will, F or alpha-high patients favoring Mervatuximab in overall survival, and in the PS2 plus, so the properly identified Feralpha high patients, there was a very nice signal for OS favoring Mervatuximab over-investigator-choice chemotherapy. You're right, in a relatively small subset and it was post hoc. And so all of these reasons make us confident that overall survival in Mirosol will trend strongly in favor of myveratuximab over chemotherapy.
Speaker 5: Kelly, I really can't answer your question because the point estimate for the median, if the point estimate for the medians are less than 1.5 months, that doesn't tell me the totality of the treatment of Mervituximab over investigator choice chemotherapy, where hazard ratio is the most appropriate statistical measure. What I would say is we anticipate a statistically significant improvement in progression-free survival with a p-value less than.05, and the point estimates for the median for each arm will be what they will be.
Anna Berkenblit: And my prior point, that will have greater than 60% of the events, so the OS data will be relatively mature and interpretable at the time of the primary PFS analysis is important. You're right; we enrolled a little over 450 patients, so the study does have reasonable power to detect a statistically significant improvement in overall survival, but we do not need that for regulatory approval either in the U.S. or Europe. No drug for ovarian cancer has been approved based on an overall survival benefit.
Speaker 3: And then overall survival will certainly be part of the overall assessment that FDA does when they look at benefit risk. That's helpful. Thank you. Thank you. Our next question comes from the line of Estika Gunwardin with Truist. Your line is now open. Hi. Good morning, guys, and thanks for taking the questions. Just a quick one on the EllaHare commercial rollout. Our KLL check suggested that one of your diagnostic vendors, NeoGenomics, has some issues with processing and this was causing some delays in test general. But as far as we understand that these issues have recently been resolved, I just want to confirm that this is indeed the case and that there's no testing bottlenecks now. And then related to that, was the 30 to 35 million guidance for EllaHare sales for this year based on sales made during that period when you had this bottleneck? Or is it purely taking account the more recent run rate? And then I have a quick follow up. Yeah, so no bottleneck in testing, you know, all.
Anna Berkenblit: So as long as we see a positive trend in the right direction, we'll be fine, and there is a chance we could hit statistical significance. Again, the stronger the OS data, the easier the conversations are in Europe, particularly around payers and access and the value propositions. That's very helpful.
Anna Berkenblit: And maybe from a modeling perspective, looking at the Gloriosis study, I'm just curious how we should think about the performance in terms of PFS for the Avast and control arms. Yeah, so, um, that's a good question, Andy, and it's not one that can be easily answered based on the data from published studies looking at the triplet in and of itself, because the PFS data from, say, the Ocean Study and the GOG-213 study is counted from the date of randomization for the triplet and then continues on, including the triplet duration, and then as well as the Avastin maintenance
Speaker 4: four of the central labs are up and doing very robust business. The fourth lab is a small regional lab in Las Vegas, but the three key labs which include LabCorp, NeoGenomics, as you mentioned, and Keras are doing large volumes of testing and there's no bottleneck. We've not given revenue guidance for Ella here, and we've deliberately done that given the early days of the launch. Obviously, many of you have provided your own estimates and we look forward to reporting out data on a quarterly basis as we move forward. What we're trying to do with you is give you a qualitative assessment of how the launch is proceeding based on what we think are the important metrics. As we've discussed, testing has exceeded our expectation. Adoption in the community has exceeded our expectation. Our academic accounts are our largest accounts as we would have anticipated.
Anna Berkenblit: So in our study, you may remember, we randomized patients at the time of maintenance. So any patient, as long as they have not progressed, will be randomized to MRVVV-V-V-V-MATV-MENTANCE. And so with that, you know, we've worked with our statisticians to do some modeling, and I think it's clear we have a very clear understanding of that that has guided the sample size and the hazard ratio, et cetera, that we've used to design the study.
Anna Berkenblit: I think we'll leave the details of that for another time. But I think the important point is that, for those patients who have not progressed, Avastin maintenance has modest efficacy. And I think with Mervituximab plus Avastin, based on the strength of our doublet data, we anticipate a long progression-free survival.
Speaker 4: And we continue to work nicely through the coverage decisions. And we started with a strong base at the beginning of this year. And Todd and his team have done an exceptional job in terms of improving both our Medicare and commercial coverage. The engagement with the compendia has been positive to include the combination. So all of the things that we would hope for as a new entrant in the market have materialized nicely. And our goal ultimately is to report out the quantitative metrics to go along with these qualitative in regular order and in connection with the next earnings call. Okay, great. Just my quick follow up then is up to 1500 diagnostic tests that were a patient that was screened and maybe you can give any color on more recent numbers too.
Anna Berkenblit: That's helpful. Thank you so much.
Anna Berkenblit: Our next question comes from the line of Kelly Shee with Jeffries, Yerline Snowb, Thank you for taking my questions. This is a follow-up regarding the OS data to be released in the Miracov Update. I'm just curious, you just mentioned the OS benefit will not be the basis for the full approval discussion. And I'm curious that in the case, if the medium TFS benefit is less than 1.5 months over chemo, would the regulatory agency put more weight on evaluating OS benefits?
Speaker 3: About what percentage of them were from patients who are currently on a 1st or 2nd line therapy for ovarian cancer? Just trying to see if there's a way for us to back out what the more immediate pent up demand could be. Thanks. Well, we don't exactly know at what state each patient is at. I think what we found in the beginning was that we did have a lot of patients that were waiting for this product. So the testing early on was directly related to a. A platinum resistant patient that was due to move on therapy. But as mark alluded to earlier, the testing has been shifting and physicians are moving earlier and practices are moving earlier. To earlier diagnosis and so really difficult for us to determine the actual place in therapy for when the testing actually occurred. Thanks guys appreciate the color.
Anna Berkenblit: So Kelly, I really can't answer your question because the point estimate for the median, you know, if the point estimate for the medians is less than 1.5 months, that doesn't tell me the totality of the treatment of Mervatuximab over-investigator-choice chemotherapy, where the hazard ratio is the most appropriate statistical measure. And so what I would say is, you know, we anticipate a statistically significant difference. a significant improvement in progression-free survival with a p-value less than.05, and the point estimates for the median for each arm will be what they will be. And then overall survival will certainly be part of the overall assessment that FDA does when it looks at benefit risk.
Speaker 3: Thank you. Our next question comes from the line of Daniel Wall with JP Morton. Your line is now open. Good morning. Thank you for taking my question. Two questions. First, regarding the Vertice Agreement, considering recent attempts to use ADCs for conditioning by going after, for example, CD117, how differentiated are some of the targets you are due or the Vertice going after? And second question, understanding that it's been only been a few months for Ella here, but given that it's a drop shipment based ordering, what's your visibility on the persistence of use? Right. So as it relates to Vertice, we're not at liberty to comment on the targets other than to say that these are being used in conjunction with their gene editing programs. And we're very pleased to be partnering with, you know, with companies, the quality of Vertax. And that in terms of persistence, again, it's early. I mean, what we could say is, you know, a significant and growing percentage.
Anna Berkenblit: That's helpful. Thank you. Thank you. Our next question comes from the line of Estika Gounwardine with Truis. Your line is now open. Hi, good morning, guys, and thanks for taking questions. Quick one on the LHare commercial rollout. Akeloch checked suggested that one of your diagnostic vendors' new genomics had some issues with processing, and this was causing some delays in test turnaround. But as far as we understand, these issues have recently been resolved
Unknown Executive: resolved I just want to confirm that this is indeed the case and that there's no testing bottling.
Unknown Executive: Now, related to that, was the 30 to 35 million guidance for LA sales for this year based on sales made during that period when you had this bottleneck, or is purely taking account the more recent run rate and then have a quick follow-up. Yeah, so no bottleneck in testing. You know, all four of the central labs are up and doing very robust business. The fourth lab is a small regional lab in Las Vegas, but the three, you know, key labs, which include Lab Corp, Neogenomics, as you mentioned, and Karris are doing, you know, large volumes of testing, and there's no bottleneck.
Unknown Executive: We've not given revenue guidance for L.A., and we've deliberately done that, given, you know, the early days of the launch. Obviously, many of you have provided your own estimates, and we look forward to reporting out data on a quarterly basis as we move forward. You know, what we're trying to do with you is give you, you know, a qualitative assessment of how the launch is proceeding based on what we think are the important metrics.
Speaker 4: I think, you know, realistically, Jonathan, we'd like to have two solid quarters under our belt before providing guidance. So, you know, I could imagine as we report out our second quarter earnings late in July or in early August that we would be in a position to give some guidance. And at that point, you know, we would have some of the information that we're, you know, that.
Unknown Executive: And so, you know, as we've discussed, testing has exceeded our expectations, and adoption in the community has exceeded our expectations. Our academic accounts are our largest accounts, as we would have anticipated. And, you know, we continue to work nicely through the coverage decisions. And we started with a strong base, you know, at the beginning of this year, and Todd and his team have done an exceptional job in terms of improving both our Medicare and commercial coverage.
Speaker 4: in position with respect to the value of individual targets in terms of anticipated patient starts, revenue, et cetera, and titrating those data in are all really, really important. And then, Sarge, on the second question, oh, Cashew, one right. Yeah. So, the first point to make is where we are with cash and cash equivalents and the application of the auditing test, we shared in this morning that that.
Unknown Executive: The engagement with the compendia has been positive, including the accommodation. So all of the things that we would hope for as a new entrant in the market have materialized nicely. And, you know, our goal ultimately is to report out the quantitative metrics to go along with these qualitative metrics in regular order in connection with the next earnings call. Okay, great. Just my quick follow-up then is up to 1,500.
Unknown Executive: diagnostic tests that were performed on a patient that was screened, and maybe if you can give them in color on more recent numbers,
Speaker 4: We will be sharing in our SEC filing that creates a going concern situation for the business. But that measure excludes, when you're in a launch phase like we are, it excludes essentially all product revenue. They may be giving you credit for pennies on the dollar. So what we wanted to make sure that people understood clearly was that with the addition of our expected Ella here at revenue that we've got significantly more than 12 months worth of cash for the business. That said, we are evaluating additional options to finance the business, which would include, for example, royalty financing with respect to the anticipated...
Unknown Executive: do you know about how percentage of them were from patients who are currently on a first or second line therapy for ovarian cancer, just trying to see if there's a way to
Unknown Executive: Over here in cancer, just trying to see if there's a way first to back out what the more immediate pent-up demand could be.
Unknown Executive: Well, we don't exactly know at what stage each patient is at. But I think what we found in the beginning was that we did have a lot of patients that were waiting for this product. So the testing early on was directly related to a platinum-resistant patient that was due to move on therapy. But as Mark alluded to earlier, the testing has been shifting, and physicians are moving earlier, and practices are moving earlier to, you know, know, earlier diagnosis. And so it is really difficult for us to determine the actual place in therapy where the testing actually occurred.
Speaker 4: growth of the product and there's interest there. And then, you know, more classically follow on offerings for the business and potentially even a modest amount of debt. So, there's the things that we're all evaluating. But I think again, the most important point for everyone here is when we look at our business plan to include cash, cash equivalents, anticipated revenue from Ella here. And also, you know, we've got this very broad portfolio of partnering agreements that include, you know, multiple folks with very active floor bounds to include, for example, Hua Deng who expects the file with the FDA, the, you know, Chinese FDA, that, you know, we would get a milestone payment upon filing. And that's coming in the second half of this year. So, all that stuff gets excluded from the accounting analysis. But when we look at the full business plan, we've got more than 12 months of cash. Got it. Thank you. Thank you. Our next question comes from the line of Peter Lawson with Barclays. Your line is no open.
Unknown Executive: Thanks, guys. Appreciate the call from us.
Unknown Executive: Thank you. Our next question comes from the line of Daniel Wall with J.P. Morgan. Your line is now open.
Unknown Executive: Good morning, thank you for taking my question. There are two questions. First, regarding the vertex agreement, considering recent attempts to use ADCs for conditioning by going after, for example, CD-117, how differentiated are some of the targets you or the vertex are going after? And second, understanding that it's only been a few months for ELA here, but given that it's a drop shipment-based ordering, what's your visibility on the persistence of use? Right?
Unknown Executive: Right, so as it relates to Vertex, we're not at liberty to comment on the targets other than to say that these are being used in conjunction with their gene editing programs, and we're very pleased to be partnering with, you know, with the quality of, uh, Vertex. And then in terms of, you know, persistence, again, it's early. I mean, what we can say is, you know, a significant and growing percentage of the orders are repeat orders or accounts who are repeat customers. So we're obviously very encouraged by that, but again, you know, we just don't have a window into the what, you know, what, how long the duration of therapy will be at this point.
Speaker 4: Great, thanks so much for taking the question. Just the plans around the build out for the commercial infrastructure in the EU and Does your expense guidance include that EU commercial infrastructure? It does. It does. I mean, obviously in, you know, 2023, that's going to be pretty limited. So we do have ahead of our international business We have a mighty one room office in Zug as we speak, which is the start of what we're doing. But the MAA filing would come later in the year. Approval would come in 2024. You know, for many of you have experience following products being launched in Europe , the actual launch and commercial sales are sequenced according to reimbursement at a national level. So, you know, like many companies, we expect to start with Germany, but that would be very late in 2024. So we can approach this in a very judicious way. Obviously, we've had some very robust clinical development in Europe from, you know, all of our pivotal studies.
Unknown Executive: Great. Thank you. Thank you. Our next question comes from the line of Jonathan Chang, with SVB securities. Your line is now open.
Unknown Executive: Hi guys, thanks for taking my question. First question; can I provide more?
Unknown Executive: Color around when this year we could get the LHare product revenue guidance.
Unknown Executive: Would need to happen first before you're in a position to give guidance here. And then, second, congrats on the Vertex Partnership. Can you talk about how you're thinking about different options for extending the cash runway? Thank you.
Unknown Executive: The cash runway. Thank you. Yeah, so, you know, I think, realistically, Jonathan, we'd like to have, you know, two solid quarters under our belt before providing guidance. So, you know, I could imagine, as we report out our second quarter earnings late in July or early August, that we would be in a position to give some guidance. And at that point, you know, we would have some of the information that many of you are reasonably asking at this point, you know, what's your duration of therapy? How do you think about the accounts?
Unknown Executive: Where is the, you know, where's the business coming from? And, you know, I think we'll have a much clearer idea of that and also, you know, the strengths of the trends, a better evaluation. You know, we have a going position with respect to, you know, the value of individual targets in terms of anticipated patient starts, revenue, et cetera, and, you know, titrating those data are all... Really, really important. And then, sorry, John, second question. Oh, Cash 1, right, yeah.
expectations. So, you know, we did 1,500 tests between the approval date and the end of the year. The volume of testing had increased. The ease of testing has not proven to be a barrier to entry. And I'll just repeat what I said earlier, which was this is a position base that is highly accustom to testing. In fact, their receptivity to it exceeded our expectation. And that's because
Unknown Executive: So, you know, the first point to make is where we are with cash and cash equivalents and the application of the auditing test. We shared in the, in the, in the, this morning that, you know, that creates a going concern situation for the business. But that measure excludes when you're in a launch phase like we are; it excludes essentially all product revenue. They may give you credit for pennies on the dollar.
They started out more than a half a decade ago looking for BRCA mutations, moved on to homologous recombination deficiency testing. And so the layering in of folate receptor alpha has proven to be quite easy for these folks. They've integrated it. And what we're seeing is a significant percentage of newly diagnosed patients being assessed for their FR alpha status, which we think is very encouraging. Thank you. I'm sure it's probably been through before, but just around the change in the guidance in Mirasol from early 23 to QQ, any kind of technical reasons around that? Or was it kind of a longer than expected time for them to gain PFS events? Yeah, so slightly longer period to get the PFS events. We originally had guided to before the end of December in 2022, and now we're imminent. So our models are as good as they can be, and clearly our models weren't perfect. And there's other reasons you could speculate. Maybe the patients on Mirtatuximab are doing a bit better. Maybe the patients on IC chemo are doing a little bit better. Maybe all of the patients are doing a little bit better. And maybe there's a combination of all of these factors. So don't know. Not worried. Definitely will trigger the final PFS analysis.
more than a half a decade ago looking for brachovetations, moved on to homologous recombination, deficiency testing. And so the layering in folate receptor alpha has proven to be quite easy for these folks. They've integrated it. And what we're seeing is a significant percentage of newly diagnosed patients being assessed for their FR alpha status, which we think is very encouraging. Thank you. I'm sure it probably been true before, but just around the change in the guidance and merisol from early 23 to 2Q. Any kind of technical reasons around that? Or was it kind of a longer than expected time for them to gain PFAS events? Yeah, so slightly longer period to get the PFAS events. We originally had guided to before the end of December in 2022. And now we're imminent. So, you know, our models are as good as they can be and clearly our models weren't perfect. And, you know, there's other reasons you could speculate. Maybe the patients on murder toughs and that are doing a bit better. Maybe the patients on IC chemo are doing a little bit better. Maybe all of the patients are doing a little bit better. And maybe there's a combination of all of these factors. So don't know, not worried. Imminent, imminently will trigger the final PFF analysis. Great. Thank you. Thanks so much.
Unknown Executive: So what we wanted to make sure that people understood clearly was that, you know, with the addition of our expected Eleher revenue, we've got significantly more than 12 months' worth of cash for the business. That said, we are evaluating additional options to finance the business, which would include, for example, royalty financing with respect to the anticipated growth of the product, and there's interest there, and then, you know, more classically follow-on offerings for the business, and potentially even a modest amount of debt.
Unknown Executive: So those are things that we're all evaluating. But I think, again, the most important point for everyone here is when we look at our business plan to include cash, cash equivalence, anticipated revenue from Ella here, and also, So, you know, we've got this very broad portfolio of partnering agreements that include, you know, multiple folks with very active programs, including, for example, Huadung, who expects to file with the, you know, Chinese FDA, that we would get So all that stuff gets excluded from the accounting analysis, but when we look at the full business plan, we've got more than 12 months of cash. I got it.
Thank you. This concludes the Q&A session. I would now like to hand the conference back over to the team for closing remarks. Great. Well, thank you very much to join us today as you can hear from the comments here. There's a lot of excitement for the business as we come into 2023 and look at the year ahead. The launch is exceeding our expectation and we have a number of important readouts upcoming. So look forward to talking to you as we work through those data and report out subsequent earnings. So thanks very much. This concludes today's conference call. Thank you for participating. You may now disconnect. Thank you. And you can dial star 11. Thank you.
Unknown Executive: Thank you. Thank you. Our next question comes from the line of Peter Lawson with Barclays; your line is no. Great, thanks so much for the technical question.
Unknown Executive: Just the plans around the build out for the commercial infrastructure in the EU and does your expense guidance include that? Yes, it does.
Unknown Executive: I mean, obviously, in, you know, 2023, that's going to be pretty limited. So we do have our international business ahead of us. We have a mighty one-room office in Zoug as we speak, which is the, you know, the, you know, the start of what we're doing. But, you know, the MAA filing would come later in the year, and approval would come in 2024.
Unknown Executive: And, you know, many of you have experience. Following products being launched in Europe, the, you know, the actual launch and commercial sales are sequenced according to reimbursement at a national level. So, you know, like many companies, we expect to start with Germany, but that would be very late in 2024. So we can approach this in a very judicious way. Obviously, we've had some very robust clinical development in Europe from, you know, all of our pivotal studies, and we will have for Gloria and 420 as well.
Unknown Executive: So the experience base among ovarian cancer treaters in Europe is already pretty rich as it relates to Elahir here, Peter. So, you know, the last market research we did just looking at the key five countries. More than 70% of patients are treated at just 65 centers.
Unknown Executive: And of course, we've got significant overlap with those centers in terms of where we've gone with our clinical trials. So, again, we are approaching this in a judicious manner, and the incremental commercial investment required to tap into a market with that level of concentration is very manageable. Thank you. And then, just as regards diagnostic testing, how is that going? Any wrinkles that have developed, or is it going smoothly, and expect just details around that?
Unknown Executive: Yeah, so we had a chance to catch folks up a little bit earlier on the call, I think, before you joined Peter. But, you know, the testing has just exceeded our expectations. So, you know, we did 1,500 tests between the approval date and the end of the year. The volume of testing has increased. The ease of testing has not proven to be a barrier to entry. And I'll just repeat what I said earlier, which was that this is a physician base that is highly accustomed to testing.
Unknown Executive: In fact, their receptivity to it exceeded our expectations. And that's because, you know, they started out more than a half a decade ago looking for the Bracca mutation, then moved on to homologous recombination deficiency testing. And so the layering in of folate receptor alpha has proven to be, you know, quite easy for these folks.
Unknown Executive: They've integrated it, and what we're seeing is, you know, a significant percentage. of newly diagnosed patients being assessed for their FR-alpha status, which we think is very encouraging. Thank you. I'm sure it's probably been through before, but just around the change in that guidance in Mirosol from early 23 to 2Q, any kind of technical reasons around that, or was it kind of a longer than expected time for him to gain PFS events?
Unknown Executive: Yeah, so, slightly longer period to get the PFS events. We originally had guided to before the end of December in 2022, and now we're imminent. So, you know, our models are as good as they can be, and clearly our models weren't perfect. And, you know, there's other reasons you could speculate.
Unknown Executive: Maybe the patients on myrbitoxinab are doing a bit better. Maybe the patients on IC chemo are doing a little bit better. Maybe all of the patients are doing a little bit better, and maybe there's a combination of all of these factors.
Unknown Executive: So I don't know, not worried. Eventually, the final PFS analysis will trigger. Great. Thanks so much. Thank you. This concludes the Q&A session. I would now like to hand the conference back over to the team for closing remarks. All right. Well, thank you very much for joining us today. As you can hear from the comments here, there's a lot of excitement for the business as we come into 2023 and look at the year ahead.
Unknown Executive: The launch is exceeding our expectations, and we have a number of important readouts upcoming. So I look forward to talking to you as we work through those data and report out subsequent earnings. So thanks very much. This concludes today's conference call. Thank you for participating. You may now disconnect.
Unknown Executive: and I don't know. Thank you. Thank you. Thank you. Thank you. Thank you.
I have.