Q3 2023 ImmunoGen Inc Earnings Call

Speaker 1: Good morning ladies and gentlemen, and welcome to immunogen's third quarter, 2023 financial and operating results conference call. Today's conference is being recorded at this time. I'd like to turn the call over to Annabelle Chen, head of investor relations. Please go ahead.

Good morning, ladies and gentlemen, and welcome to immuno Jones third quarter 2023 financial and operating results Conference call. Today's conference is being recorded at this time I'd like to turn the call over to Annabel churn headwind.

Best Relations. Please go ahead.

Speaker 2: Good morning, and thank you for joining today's call. Earlier today, we issued a press release that includes a summary of our recent operating progress and third quarter financial results.

Good morning, and thank you for joining today's call earlier today, we issued a press release that includes a summary of our recent operating progress and third quarter financial results.

Speaker 2: This press release, a recording of this call, and an updated corporate deck can be found under the investors and media section of our website at immunogen.com.

Yes, that's really a recording of this call and an updated corporate deck can be found under the investors and media section of our website at immunogen Dot com.

Speaker 2: With me today are Mark entity, our president and CEO . Isabella, our chief commercial officer. Michael back themselves are EVP of research development and medical affairs. And Lauren white, our CFO .

With me today are mark entity, our president and CEO, Isabella, California, our Chief commercial officer.

Michael back to yourselves, our EVP of research development and medical Affairs.

Lorne White our CFO.

Speaker 2: During today's call, we will review recent progress for the business, our financial results, and highlight upcoming anticipated events.

During today's call. We will review recent progress for the business, our financial results and highlight upcoming anticipated at them.

Speaker 2: We will be making forward looking statements based on our current expectations and beliefs.

He will be making forward looking statements based on our current expectations and beliefs.

Speaker 2: These statements are subject to risks and uncertainties, and our actual results may differ materially.

These statements are subject to risks and uncertainties and our actual results may differ materially.

Speaker 2: Please consult the risks outlined in our press release issues this morning in the risk factor section of our most recent annual report on form 10K and quarterly report on form 10Q. And then our other SEC filings which are available at FCC.gov and immunogen.com. With that, I'll...

Please consult the risks outlined in our press release issued this morning, and the risk factors section of our most recent annual report on Form 10-K, and quarterly report on Form 10-Q, and in our other SEC filings, which are available at SEC Gov, and immunogen Dot com.

With that I'll turn the call over to Mark.

Speaker 3: Thanks, Annabelle. Good morning, everyone, and thank you for joining us today. This has been another productive quarter for Immunigen, highlighted by the ongoing exemplary execution of the commercial launch for LA here in the US, progress made towards both geographic and label expansion for LA here, and the advancement of our portfolio.

Thanks, Annabel good morning, everyone and thank you for joining US today. This has been another productive quarter for immunogen highlighted by the ongoing exemplary execution of the commercial launch for early here in the U S progress made towards both geographic and label expansion for Ala here and the advancement of our portfolio.

Speaker 3: Starting with a commercial update, we delivered a strong quarter with Ellie here generating just over $105 million in net sales, resulting in over 210 million in revenue year to date, which puts us on track for one of the most successful oncology launches in a decade.

Starting with a commercial update we delivered a strong quarter with early here generating just over $105 million in net sales, resulting in over $210 million in revenue year to date, which puts us on track for one of the most successful oncology launches in a decade.

Speaker 3: This performance is driven by a combination of factors, including strong adoption of FFR Alpha testing and corresponding product ordering in a population with high on that need, would robust uptake in our labeled indication across both academic and community settings, as well as discretionary use in a broader patient population based on NCCN guidelines, including use of LHM therapy and later lines and in combination with Bepathy's Amat.

This performance was driven by a combination of factors, including strong adoption of fr Alpha testing and corresponding product ordering in a population with high unmet need with robust uptake in our labeled indications across both academic and community settings as well as discretionary use in a broader patient population based on empty.

C N guidelines, including use of valor here monotherapy in later lines and in combination with Bevacizumab.

Speaker 3: rapid achievement of broad access and reimbursement.

Rapid achievement of broad access and reimbursement.

Speaker 3: Increased breadth and depth of prescribing driven in part by penetration into priority accounts, and increased awareness of L of here driven by engagement by our medical affairs team, the compelling data from Mirosol and positive physician and patient experiences.

Increased breadth and depth of prescribing driven in part by penetration into priority accounts and increased awareness abella here driven by engagement by our medical affairs team the compelling data for Mirasol and positive physician and patient experiences.

Speaker 3: Looking forward, we expect continued growth albeit at a moderating case supported by continued focus on execution with respect to our launch in paratives, a strong and growing for scriber base and Ella here becoming the medicine of choice for patients with FR alpha positive.

Looking forward, we expect continued growth, albeit at a moderating pace supported by continued focus on execution with respect to our launch imperatives are strong and growing prescriber base and Ella here, becoming the medicine of choice for patients with Fr Alpha positive disease, Isabel we'll have more to say about our current and future business in a moment.

Speaker 3: Isabelle will have more to say about our current and future business in a moment.

Speaker 3: As we aim to expand the geographic footprint for LA here, and look to bring this novel ADC to patients globally, we are pleased to share that the EMA has accepted our marketing application to support potential European approval, and our partner, Wadun, received acceptance of the NDA in China.

As we aim to expand the geographic footprint for early here and look to bring this novel ADC to patients globally. We are pleased to share that the EMA has accepted our marketing application to support potential European approval and our partner <unk> received acceptance of the NDA in China. In addition.

Speaker 3: In addition, we announced the collaboration with Decada to develop and commercialize Ella here in Japan and submitted a supplemental BLA to FDA to support the conversion of the accelerated approval of Ella here to full approval here in the U.S.

We announced the collaboration with Takeda to develop and commercialize Ela here in Japan and submitted a supplemental BLA to FDA to support the conversion of the accelerated approval of elder here to full approval here in the U S.

Speaker 3: In step with our commercial efforts, we are advancing the broader Ella here development program to support label expansion into platinum sensitive disease, and to position Ella here as the combination agent of choice in Ovarian camp.

Stuck with our commercial efforts, we are advancing the broader LNG or development program to support label expansion into platinum sensitive disease at the position of the Ela here as the combination agent of choice in ovarian cancer.

Speaker 3: In this context, we are pleased to share that our piccolo phase 2 trial, evaluating L.A.H. Monotherapy and Platinum Sensitive Ovarian Cancer, has met its primary endpoint of objective response rate.

In this context, we are pleased to share that our piccolo phase III trial evaluating <unk> monotherapy in platinum sensitive ovarian cancer has met its primary endpoint of objective response rate.

Speaker 3: Noting that PICOLO is ongoing and patients are continuing to receive LA here, today we've observed no new safety signals in this patient population. These data represent an important step towards expanding LA here into the platinum-sense dissenting and Michael discussed these data in more detail shortly.

Noting that piccolo is ongoing and patients are continuing to receive like year to date, we've observed no new safety signals in this patient population. These data represent an important step towards expanding ela here into the platinum sensitive setting and Mike will discuss these data in more detail shortly.

Speaker 3: Turning briefly to the rest of the pipeline. In our second Pivotal Program, PVAC, we look forward to reporting data from our PVAC triplet and frontline AML later this year at Ash. And we are on track with top-line data from the Pivotal frontline, DeNovo cohort in BP, DECN, expected in 2024. In addition, IMGC 936 and IMGN 151 are progressing when we remain focused on reinvesting in our research capabilities and expanding our pipeline.

Turning briefly to the rest of the pipeline and our second pivotal program feedback, we look forward to reporting data from our <unk> triplet and frontline AML later this year at Ash and we are on track with top line data from the pivotal frontline de Novo cohort in <unk> expected in 2024.

In addition, <unk> 93, six and <unk> five one are progressing well, we remain focused on reinvesting in our research capabilities and expanding our pipeline.

Speaker 3: Lastly, I'm pleased to report that we've strengthened our leadership team with the recent appointment of Warren White as Chief Financial Officer, and commensurate with our expanding commitment to continued innovation of our ADC platform, we welcome Heather Hewitt as Chief Scientific Officer.

Lastly, I'm pleased to report that we strengthened our leadership team with the recent appointment of war and White as Chief Financial Officer, and commensurate with our expanding commitment to continued innovation of our ADC platform. We welcome Heather Hewitt as Chief Scientific officer, with an experienced management team in place and a strong.

Speaker 3: With an experienced management team in place and a strong balance sheet, we are well positioned to expand the commercial opportunity for Ella here and in parallel, continuing to advance and invest in our pipeline. With that, I'll turn the call over to Isabel to cover our commercial progress. Isabel.

Balance sheet, we are well positioned to expand the commercial opportunity for Ela here and in parallel continuing to advance and invest in our pipeline with that I'll turn the call over to Isabella to cover our commercial progress Isabelle.

Speaker 2: Thank you, Mark. The commercial team built upon the strong momentum established in the first half of the year and delivered another strong quarter as we continue to make progress towards position a last year as a standard of care for fully receptor alpha positive ovarian cancer.

You Mark the commercial team to build upon the strong momentum established in the first half of the year and delivered another strong quarter as we continued to make progress towards precision.

As a standard of care portfolios receptor alpha positive ovarian cancer.

Speaker 4: In the third quarter, we saw a 35% sequential growth for the prior quarter. We are pleased with our performance in launch and believe it is due to a combination of four key factors including a strong adoption in an area of high and methanie.

In the third quarter, we saw a 35% sequential growth versus the prior quarter. We are pleased with our performance since launch and believe it used a combination of four key factors, including <unk>.

Strong adoption in an area of high unmet need.

Speaker 4: Dapi Lactis and Reinvestment Coverage, the solid execution of our commercial customer facing team, an increased precision experience and awareness of the benefits these noble treatment brings to patients with advanced ovarian cancer.

Access and reimbursement coverage, the solid execution of our commercial customer facing team.

And increased precision experience on awareness.

These novel treatment brings to patients with advanced ovarian cancer.

Speaker 4: Let me take some time for this each of these key factors in mode.

And it takes some time to address each of these key factors in more detail.

Speaker 4: First, let me hear some insights into the dynamics of serve while launching in Tunisia or high and mid.

First let me share some insight into the dynamics of Sir while launching into an area of high unmet need.

Speaker 4: Starting with the identification of the legs, both patients, almost a year into our launch, we have seen the overall awareness for the final testing increase and rapid adoption of the folio-1 diagnostic denincorporated as a standard component of the initial panel conducted on newly diagnosed patients and for patients moving to the next line of therapy.

Starting with the identification of early vocations.

Patients almost a year into our launch we have seen the overall awareness for a final thought testing increased and rapid adoption of the <unk>, one diagnostics being incorporated as a standard component of the initial pilots conducted a newly diagnosed patients.

What patients moving to the next line of therapy.

Speaker 4: Our market research indicates that over 80% of physicians are familiar with a faulty testing, up from a baseline of under 50% at the time of approval.

Our market research indicates that over 80% of precision familiar.

Media with FY <unk>.

Ill turn a baseline of under 50% at this time a lot cooler.

Speaker 4: It is becoming the standard cares that will enable oncologists to rapidly incorporate Ella here into the treatment decision. It is necessary to say that the testing has not been a barrier to adults.

It is becoming the standard of care that will enable oncology to rapidly incorporate <unk> into their treatment decision.

The state testing has not been a barrier to adoption.

Speaker 4: Since launch, we have endeavored to provide the market with the number of tests conducted at our three largest centralized labs.

Since launch we have endeavored to provide the market with a number of tests conducted at our three largest centralized loves us.

Speaker 4: As of the end of the quarter, that number stood at roughly 16,000 tests. However, with approximately 40 labs now certified to run the test, our visibility into the number of tests performed has decreased, and we will discontinue reporting on this metric on subsequent calls.

So at the end of the quarter that number stood at roughly 16000 deaths.

However, with approximately 40 labs now certified to branded death, our visibility into the number of dead perform has decreased and we will discontinue reporting on this metric on subsequent calls.

Speaker 4: We will however continue to report the foliar receptor alpha positive rate, which remains between 35 and 40% in line with our expectations.

We will however continue to report the fully receptor alpha positive rate will remain between 35 and 40% in line without expectations.

Looking at patient adoption.

Speaker 4: Ella here addresses a high unmet need among platinum-resistant ovarian cancer patients, as indicated by the initial strong uptake in later lines where the need has been greatest. In the first quarter, the vast majority of patients were from later lines of therapy, and as the launch has progressed, we'll set a shift to earlier lines. This is a slow and steady trend, and we expect this to become a key driver of future growth.

They're not here addresses a high unmet needs among platinum resistant ovarian cancer patients as indicated by the niche that John uptake later lies with the knee has been great.

The first quarter. The vast majority of patients were from later lines of therapy and as the launch has progressed lasalle ships to earlier lines.

No on a steady trend and we expect this to become a key driver of future growth.

Speaker 4: Moving to our second key factor, access and reverse.

Moving to our second key factor axis hundreds of retina.

Speaker 4: Being by the affordable access team, we secure coverage policies aligned to our label for over 95% of both Medicare and commercial life within the first 7 months of launch, exceeding another benchmark 80.

DRAM by the affordable access team, we secure coverage policies are aligned to our label for over 95% of both Medicare and commercial lives. We think the first seven months of launch exceeded our normal benchmark agencies.

Speaker 4: In addition, with the inclusion of LIT and NCCN guidelines, we have seen utilization in a broad population, including the use of monotherapy-related lines, and in combination, we're going to see some up in low, medium, and high FR-alpha representation.

Yeah, Lisa with inclusion of <unk> and <unk>, we have seen.

<unk> seen utilization in a broad population, including the use of monotherapy later in life and in combination with benefits of mob in low medium and high fr Alpha expression.

Speaker 4: Third, a strong execution by our commercial team driving adoption of LX.

Third our strong execution by our commercial team driving adoption of our.

Speaker 4: Our customer facing field team has been highly active since long.

Our customer facing sales team had the highly active since launch.

Speaker 4: During the third quarter, they continue to engage priority targets to broaden our reach, resulting in continued growth in both academic and community.

The third quarter, they continued to engage priority targets to broaden our reach resulting in continued growth in both academic and community accounts.

Speaker 4: Complementing your account generation is a significant percentage of accounts with repeat orders.

Complementing your account generation is a significant percentage of accounts with repeat August while academic institutions continue to comprise our largest customers roughly 70% awarded during the quarter came from non academic institutions and community based oncology groups.

Speaker 4: While academic institutions continue to comprise our largest customers, roughly 70% of orders during the quarter came from non-academic institutions and community-based on-quality groups, consistent with the prior quarter.

He's been with the prior quarter.

Speaker 4: And lastly, increase physician experience and awareness. We place a high priority on increasing awareness and cultivating a positive physician and patient experience.

And lastly increased decision experienced an awareness we place a high priority on increasing awareness and cultivating a positive physician and patient experience.

Speaker 4: Based on our market research, in August , with over 120 physicians across the academic and community settings, over 80% of physicians are aware of LIH.

Our market research.

With over 100000 physicians across the academic and community settings.

Over 80% of decisions are aware oli here.

Speaker 4: This has nearly doubled since April , and we are especially pleased to see awareness increasing with medical oncology.

This has nearly doubled since April and we are especially pleased to see awareness increasing with medical oncology.

Speaker 4: We attribute this to the compelling data from Mirasol and to the robust engagement by our medical affairs team, who has continued to provide a full suite of support to ensure positive physician and patient experience.

We attribute this to the compelling data from <unk> and to the robust engagement by our medical Affairs team has continued to provide a full suite of support to ensure positive physician and patient experience.

Speaker 4: As a testament to their efforts, reports from the field consistently relay enthusiastic feedback from clinicians regarding their experience with LHC.

As a testament to their efforts, we postponed the pit consistently relate into CRT feedback from clinicians regarding their experience with <unk>.

Speaker 4: In summary, we are very pleased with our performance today. And based on the market research, I just referenced, we expect continuous growth to primarily buy. Number one, increasing FR-alpha test.

In summary, we're very pleased with our performance to date and based on the market research I just referenced we expect continued growth fueled primarily by number one increasing fr alpha testing.

Speaker 4: Awareness of FRA testing as a biomarker is already high, and physicians indicate a 30% growth with the convenience of in-house testing and testing earlier in the patient journey. Two, increasing awareness of the benefits L&H brings to patients with advanced ovarian cancer.

Awareness of Fr Alpha testing as a bio market is already high and physicians indicate a 30% growth with the convenience of it in house testing and testing earlier in the patient journey to increase in awareness of the benefits <unk> brings to patients with advanced ovarian cancer.

Speaker 4: As physicians gain experience and our medical affairs team continues to educate on our clinical data in both monotherapy and in combination,

Decisions gain experience on our medical affairs team continued to execute on our clinical data in both monotherapy and in combination.

Speaker 4: Our research shows that physician education translates into increased depth and breadth of prescribing, with current prescribers projecting higher rates of utilization in both monotherapy and combination.

Our research shows that decision indication translate into increased depth and breadth of prescribing with current prescribers projecting higher rates of utilization in both monotherapy and combination.

Speaker 4: Also, we anticipate physicians previously unaware becoming new adults.

Also we anticipate decisions previously unaware becoming new adopters.

Speaker 4: Third, we also expect to see increasing treatment rates over historical benchmarks, given the compelling efficacy of LRQ and increased experience with the treatment, including the management of adverse events.

Sure.

So expect to see increasing premium rates over the historical benchmark, given the compelling efficacy and Nike and increase the experience with the treatment, including the management of adverse events.

Or.

Turning to therapy.

Speaker 4: Improving perceptions relative to the standard of care will support moving into early lines of therapy of treatment in the platinum-resistant setting.

Improving assumptions relative to the standard of care will support moving into earlier lines of therapy treatment in the platinum resistant setting.

Speaker 4: Finally, we are also currently fielding a demand study and we expect to gain additional insight into the current and future utilization of ELAHI.

Finally, we are also currently filled in as they manage study and we expect to gain additional insight into the guard on future utilization.

Speaker 4: With that, I would like to turn the call over to Mike to provide additional color on the development program and our brother pipeline. Mike.

Yeah.

I would like to turn the call over to Mike to provide additional color on the <unk> development program and our broader pipeline Mike.

Thanks is about.

Speaker 5: We were pleased to present additional data from MIRASOL, a randomized phase three trial of Elahir in platinum-resistant ovarian cancer at the 24th Annual European Society of Gynecologic Oncology Congress in September .

We were pleased to present additional data from the aerosol.

A randomized phase III trial of Ela here in platinum resistant ovarian cancer at the 24th annual European Society of Gynecologic Oncology Congress in September.

Speaker 5: Dr. Van Gorp, Professor of Gynecologic Oncology at the University of Louvain, presented two subset analyses in an oral session.

But <unk> professor of Gynecologic oncology at the University of Louisville presented to subset analysis in an oral session highlighting efficacy benefits without here versus investigator choice or IC chemotherapy and progression free survival objective response rate and overall survival.

Speaker 5: Highlighting efficacy benefits with L here versus investigator choice, or I see chemotherapy in progression, pre survival, objective response rate, and overall survival. Dr, Ben Gorp reported on subsets defined by the number of prior lines of therapy or prior part inhibitor exposure.

Dr. Bancorp reported on subsets defined by the number of prior lines of therapy or prior PARP inhibitor exposure.

Speaker 5: With no new safety signals arising from these analyses, these findings provide valuable insights for physicians into Al-Ahir's consistent clinical benefits compared to IC chemotherapy in both subsets.

With no new safety signals arising from these analyses. These findings provide valuable insights for physicians into our here is consistent clinical benefit compared to IC chemotherapy and both subset.

Speaker 5: Turning now to the broader Mirvotuximab clinical development program, we aim to expand the Alahir label into platinum-sensitive ovarian cancer and further position Alahir as the standard of care in Foley receptor alpha-positive disease. We are currently advancing three sponsored clinical trials in support of these objectives.

Turning now to the broader <unk> clinical development program, we aim to expand the <unk> label into platinum sensitive ovarian cancer and further position out here is the standard of care in fully receptor alpha positive disease.

We are currently advancing three sponsored clinical trials in support of these objectives.

Speaker 5: Let's start with Piccolo, our single arm phase 2 trial evaluating mervituximab monotherapy efficacy and safety in patients with FR alpha high platinum sensitive ovarian cancer who have received at least two prior lines of platinum containing therapy or have a documented platinum allergy.

Let's start with Piccolo, our single arm phase II trial, evaluating <unk> monotherapy efficacy and safety in patients with Fr Alpha high platinum sensitive ovarian cancer, who have received at least two prior lines of platinum containing therapy or have a documented platinum apology.

Speaker 5: The unmet medical need in this patient population is noteworthy and growing, driven predominantly by two key factors.

The unmet medical need in this patient population is noteworthy and growing.

Driven predominantly by two key factors.

Speaker 5: Even if a patient meets the clinical criteria of platinum-sensitive disease, each subsequent line of platinum-containing therapy is associated with both decreased efficacy, as measured by a lower probability of achieving an objective response and meaningful response duration, and decreased tolerability.

First.

Even if a patient meet the clinical criteria of platinum sensitive disease. Each subsequent line of platinum containing therapy is associated with the decreased efficacy.

As measured by a lower probability of achieving an objective response in meaningful response duration.

And decreased Tolerability.

Speaker 5: With this reality, available therapy for these patients today is limited.

With this reality available therapy for these patients today is limited.

Speaker 5: Second, emerging clinical data indicate that treatment with a PARP inhibitor may negatively impact the efficacy of subsequent platinum-containing therapy. Given the importance of PARP inhibitors in the maintenance setting in the first-line treatment regimen for many patients, these observations further reinforce the need for treatment alternatives.

Second <unk>.

Emerging clinical data indicate that treatment with a PARP inhibitor may negatively impact the efficacy of subsequent platinum containing therapy.

Speaker 5: No randomized phase 3 data exists for the patient population enrolled and treated in Piccolo. No level one evidence, if you will.

Speaker 5: As such, there is no agreed-upon established standard of care for patients with later-line platinum-sensitive disease.

Speaker 5: Therefore, to design this trial, we synthesized historic data of both non-platinum monotherapy and platinum-containing regimens in similar patient populations.

Speaker 5: These analyses drove the trial's standard sine and two-stage design and its statistical assumptions.

Speaker 5: Regarding the former, we defined objective response rate as the primary end point. The key secondary endpoints were frequency with duration of response, safety and tolerability were important additional study objectives.

Speaker 5: Based upon the assumed or hypothesized objective response rate, we established the trial size to rule out a confirmed objective response rate by investigators of 28%.

Proper sized objected response rate, we established the trial size to rule out a confirmed objected response rate by investigators of 28%.

Speaker 5: because an observed objective response rate exceeding 28 percent would set these data apart from the historic benchmark data I referenced above.

Because and observed objected response rate exceeding 28% would set these data apart from the historic benchmark data I referenced above.

Speaker 5: In other words, a positive trial results would require an observed or actual objective response rate that excluded 28% based upon 95% confidence intervals.

Other words it positive trial results would require an observed or actual objective response rate that excluded 28% based upon 95% confidence intervals.

Speaker 5: In the fully enrolled PICOLO trial, a total of 79 patients have been treated. Most of whom have received prior part in Hiveter therapy.

And the fully enrolled Piccolo trial, a total of 79 patients have been treated most of whom have received prior PARP inhibitors therapy.

Speaker 5: As of today, a number of those patients remain on treatment, continuing to receive myrpotoxinib.

As of today, a number of those patients remain on treatment continuing to receive more of a test ma'am.

Speaker 5: Based upon the pre-specified trial design, until the response duration for the entire study population is mature, the trial remains ongoing.

Based upon the pre specified trial design until the response duration for the entire study population is mature the child remains ongoing.

Speaker 5: However, we are able to share today that based on an interim assessment of response and safety, the primary endpoint of the study has been achieved.

However, we are able to share today that based on an interim assessment of responses safety. The primary endpoint of the study has been achieved.

Speaker 5: The investigator-assessed objective response rate excludes 28% and we anticipate an overall objective response rate of at least 48% when we report the full data in 2024.

The investigator assess subjective response rate excludes 28%.

We anticipate an overall objective response rate of at least 48% when we report a full data in 2024.

Speaker 5: Also of note, today we have detected no new safety signals with myrtidoxin masks.

Also of note to date, we have detected no new safety signals with more of a taxi ma'am.

Speaker 5: The insights I've shared today from the ongoing picola trial are meaningful. As the numerically largest datasets for Mervatuxinab reported thus far in patients with platinum-sensitive disease, we believe these data reinforced earlier previously published datasets at Mervatuxinab in combination that demonstrate Mervatuxinab's potential in FRF expressing platinum sensitive to the Loverian Cancer or Peace.

In fact, I've shared today from the ongoing pickler trial or meaningful.

Medically largest datasets <unk> reported thus far in patients with platinum sensitive disease.

<unk>. These data reinforced earlier previously published datasets it more of a Texan have in combination.

Menstruate <unk> potential in F R off of expressing platinum sensitive ovarian cancer or <unk>.

Speaker 5: Assuming a tolerability of safety profile and peace stock that remains consistent with that observed across the Mervatux-MAD development program, we see Mervatux-MAD eventually becoming a new standard of care in peace stock, assuming a trajectory similar to that already underway in platinum resistance disease.

Assuming a tolerability safety profile <unk> that remains consistent with that observed across the <unk> development program, we see more of a tux mab eventually becoming a new standard of care and <unk>, assuming a trajectory similar to that already underway and platinum resistance disease.

Speaker 5: In addition to evaluating Mervatuxemab monotherapy in Tickleau, we are advancing two trials designed to establish Mervatuxemab as the combination agent of choice and platinum sensitive ovarian cancer.

In addition to evaluating <unk> mono therapy <unk>, we are advancing two trials designed to establish more of a <unk>. It's a combination agent of choice and platinum sensitive ovarian cancer.

Speaker 5: The first is Gloriosa, our Phase 3 trial evaluating Mervatexamab plus Davis is a Mamm maintainant versus standard of care Davis is a Mamm maintainant and the second line platinum sensitive setting.

But first this glorioso phase.

Phase three trial evaluating <unk> plus services, ma'am maintenance versus standard of care Superman maintenance.

Second line platinum sensitive setting.

Speaker 5: This study builds upon our robust myrvituximab plus bevacizumab data in the platinum resistant setting, which led to the NCCN compendium listing for this combination.

Study builds upon a robust <unk> data and the platinum resistance setting.

To the MCC and compendium listing for this combination.

Speaker 5: This combination in the maintenance setting is designed to establish the opportunity for patients to benefit from even longer duration therapies with murder.

This combination in the maintenance steadiness designed to establish the opportunity for patients to benefit from even longer durations of therapy with <unk>.

Speaker 5: The second is trial 420. A single arm phase two study evaluating Mervatuxinab plus Carva Platin with Mervatuxinab continuation until disease progression in platinum-sensitive ovarian cancer patients with low, medium, or high levels of fully receptor alpha expression.

The second is try out for 20, a single arm phase two study evaluating <unk>, plus carboplatin with <unk> continuation until disease progression and platinum sensitive ovarian cancer patients with low medium or high levels of fully receptor alpha expression.

Speaker 5: Both Gloriosa and Trial 420 are enrolling in the U.S. and advancing in your

Oh, Oreo, Sir and try out for 20 or enrolling in the U S and advancing in Europe.

Speaker 5: Moving to our second pivotal program, we continue to anticipate top-line data from the Phase II cadenza trial of Tzoveca Mab's genearing or P-VAC and patients with front line and the last refractory Blastic plasma site to a dendritic cell neoplasm or BPDCN in 2024.

Moving into our second typical program, we continued to anticipate top line data from the phase two cadenza trial of <unk> or payback in patients with frontline and relapsed refractory blasted plasmacytoid dendritic cell neoplasm four P. P. D C N 2024.

Speaker 5: Given the encouraging efficacy and tolerability data we have observed as presented at the European Hematology Association annual meeting earlier this year, we are excited about PVAC as a potential new option in this rare indication.

Encouraging efficacy and Tolerability data, we have observed as presented at the European Hematology Association annual meeting earlier. This year. We are excited about feedback as a potential new option in this rare indication.

Speaker 5: In our AML program with PVEC, we continue to advance enrollment in our 802 trial of PVEC in combination with venetoclax and azacitidine, which we refer to as the PVEC triple.

M. L program with feedback we continue to advance enrollment in our 802 trial of feedback in combination with Venetoclax and a society, which we refer to as the payback triplett we.

Speaker 5: We expect to report data from this study at ASH in December .

We expect it to report data from this study at Ash in December.

Speaker 5: Two cohorts enrolled patients with newly diagnosed acute myeloid leukemia and each were designed to inform the optimal schedule of the NETA Clacks in the P-Lac triplet, a critical first step to guide further clinical development, including plan pivotal development in frontline AMF.

Two cohorts enrolled patients with newly diagnosed acute myeloid leukemia and each were designed to inform the optimal schedule a venetoclax and the feedback triplets a critical first step to guide further clinical development, including plan pivotal development frontline out.

Speaker 5: As for our earlier stage programs on IMGC936, our first-in-class Adam9 targeting ADC and Code of Element with MacroGenix, we continue to progress our non-small cell lung cancer expansion cohort and we plan to provide an update after the protocol specified interim analysis is completed, which we now expect to next year.

As for our earlier stage programs on Irgc 936 are first in class, Adam nine targeting ADC and co development Macrogenics, we continue to progress or non small cell lung cancer expansion cohort and we plan to provide an update after the protocol specified interim analysis is completed which we now expect to next.

Speaker 5: Lastly, we are progressing our phase one trial of IMG-151, our next generation anti-folate receptor alpha targeting ADC to address a broader range of folate receptor alpha expressing tumors. Initial exploration is in ovarian and immemetrial cancers and dose escalation is proceeding as anticipated.

Each year.

Lastly, we are progressing our phase one trial IMG and 151, our next generation anti bully receptor alpha targeting ADC to address a broader range of <unk> receptor opex pressing tumors initial exploration is an ovarian and endometrial cancer and dose escalation is proceeding as anticipated.

Speaker 5: With that, I will turn the call over to Lauren to cover our financials.

That I will turn the call over to Lauren to cover our financials Orange.

Speaker 6: Thanks, Mike for the 3rd quarter of 2023, we generated 113.4Million dollars in revenue, including 105.2Million dollars in net product sales of Ella here with the remainder primarily from non cash royalty revenue.

Thanks, Mike for the third quarter of 2023, we generated $113.4 million in revenue, including $105.2 million in net product sales of Ella here with the remainder primarily from non-cash royalty revenues.

Speaker 6: Operating expenses were $85.3 million. Comprised of $47.6 million of R&D expenses and $37.7 million of SGNA expenses.

Operating expenses were $85.3 million comprised of $47.6 million R&D expenses and $37.7 million of SG&A expenses.

Speaker 6: We recorded net income of $30.7 million and EPS of 10 cents.

We recorded net income of $37 million in EPS 10 cents.

Speaker 6: We ended the quarter with $605.5 million in cash on the balance.

We ended the quarter with $605.5 million in cash on the balance sheet.

Speaker 6: Our financial guidance for 2023 remains unchanged. We continue to expect revenues, excluding LA HERE sales between $45 million and $50 million, and operating expenses between $350 million and $365 million.

Our financial guidance for 2023 remains unchanged, we continue to expect revenues excluding yourself.

2000, $45 million and $50 million and operating expenses between $350 million and $365 million.

Speaker 6: Lastly, since we are quickly approaching the end of 2023, I'd like to share that we anticipate providing full-year, L-year revenue guidance for 2024 when we announce fourth quarter and full-year 2023 financial results. With that, we'll open the

Since we are quickly approaching the end of 2023 I'd like to share that we anticipate providing full year <unk> revenue guidance for 2024, when we announced fourth quarter and full year 2023 financial results.

With that will open the call for questions.

Speaker 1: Please, I'm Gentlemen, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced.

Thank you.

To ask a question you wanted your quest Star one one on your telephone and wait for your name to be announced to try a question. You May question. One one again, please stand by while we compiled candy roster.

Speaker 1: you may press star 1 1 again. Please send by while we compiled a can of us.

Speaker 1: And our first question coming from the line of John Neumann with Canaccordia La Nessa.

And first question coming from the line of John Yeoman with Candy.

10. According to your line is open.

Speaker 3: Hi there, good morning. Thanks for taking my question and great continued work. Successful launch. Just had two questions on Ali here. I'm curious.

Hi, there thanks for taking my question and great.

Work successful launch just have two questions on here I'm curious.

Speaker 7: Sure. I'm Ella here. Curious if you're seeing Ella here use in combination with the VAT and continue to grow as a share of total Ella here use. And also if you are expecting to see increased duration of therapy here. And then second, there's a quick question on what we should be looking for in terms of the Pubekama data at ASH this year.

Sure Uhm, you're curious if you're seeing alisher used in combination with the vast.

Continue to grow as a share of total L. Assure us and also if you are expecting to see increased duration of therapy here in a second just a quick question on what we should be looking for in terms of <unk> data at Ash This year.

Speaker 3: I'll ask is the relevant answer those questions.

I'll ask Isabella to answer those questions.

Speaker 4: Hey, John . Yes, well, we continue. We are very pleased with the performance in the third quarter, as you said, or 100 million in sales. We continue to track the digitalization both in monitor and in combination. While we have preliminary data on that, we could say yes, that is growth in both and we continue to see that. And our market research indicates that that that will continue to grow in the next few months. Thank you.

Hey, Joan Yes, when we continue we're very pleased with the performance and that therefore, you said alright 100 <unk>.

We continue to drive the digitalization both in monetary combination.

We have a preliminary data on that we can say, yes that is growth involved and we continue to see that and our market research indicates that that will continue to close in the next few.

Few months.

Can you. Please repeat your question in Phoenix.

Speaker 5: I think that's on. Hi, it's Mike. Yeah. Hi, John . Mike. Yeah. With respect to our upcoming data at ash, as I mentioned in the prepared.

Sure.

Hi, It's Mike Hi.

Hi, John Mike, Yeah, with respect to our upcoming data ash as I mentioned in the prepared comments.

Speaker 5: We're going to have as much data as we, essentially as we have on the two cohorts that have solidified the dose and schedule of the triplet as we move forward in 802. So.

We're going to have as much data as we essentially as we have on on the two cohorts that have.

Solidified the dosage schedule of the triplet as we move forward in 802, so advocacy.

Speaker 5: you know, efficacy data, safety data, obviously it's an ongoing study. And so sort of the maturation of those data with respect to response duration.

<unk> data safety data, obviously, it's an ongoing study and so I sort of the maturation of those data with respect to response duration is something that that's gonna take more time, but.

Speaker 5: is something that's going to take more time, but I think we'll be able to expand a fair bit on what I just shared.

It will be able to expand a fair bit on what I just shared.

Okay, great. Thank you.

Thank you one moment for our next question.

Speaker 1: And our next question coming from the line of Michael Schmidt with Guggenheim, Yelena Sophan.

And our next question coming from the line of Michael Schmidt with Guggenheim, you're on a cell phone.

Speaker 7: Hey, guys. Good morning. Thanks for taking my questions and congrats on reaching cash flow positivity this quarter. Amazing job on the launch so far. Mark or Isabel, could you comment a bit more what would you think your treatment share is at this point in time in the platinum resistant ovarian cancer setting as opposed to other patient subsets in this market?

Hey, guys. Good morning, Thanks for taking my questions and congrats on reaching a cash flow of positivity this quarter amazing job on the on the launch so far.

Mark or is about could you comment a bit more what what do you think your treatment sure is at this point in time in the platinum resistant ovarian cancer setting as opposed to other patient subsets in this market spin.

Speaker 8: It's been a very strong large obviously and then secondly, could you comment on how the piccolo trial resides potentially reached through to other trials you have ongoing in a platinum center for very belly and the leg wall right next to your chest?

<unk>.

Strong lodge obviously.

And then secondly could you comment on how the Piccolo trial result, potentially leaf through two other trials you have ongoing and apply them offensive ovarian cancer settings uhm. Thank you so much.

Speaker 3: Mike also started and then asked Isabelle and Mike to address the additional points here. So we aren't in a position to quote you with specific share at this point. The way we are looking at the business is we see some important trends that we characterize this low but steady growth as we look at.

So my call start and then ask Isabelle and and like.

Address the additional points here.

So we aren't in a position to quote you a specific sure at at this point the way we are looking at the business as we see some important trends when he would characterize it is slow but steady growth.

As we look at.

Speaker 9: the utilization of the product as monotherapy. So when we started out,

The utilization of the product is mono therapy. So when we started out the majority of the patients were fourth in later line as time has gone by what we see in the claims data is movement into earlier lines of therapy and in parallel with that we see a combination use.

Speaker 9: The majority of the patients were fourth and later line as time has gone by. What we see in the claims data is movement into earlier lines of therapy. And in parallel with that, we see combination use of the product growing as well. And so, but to sort of stand back at this point and give you a specific share number, I'm just not in a position to do that. Isabel, I don't know if you want to add anything to that.

Of of the product growing as well and so but it sort of stand back at this point and give you a specific share number I'm just not in a position to to do that as well I don't know if you wanted to add anything to that.

Speaker 4: I just would like to say that this is an area of high and that needs and where we are pleased to see a stereo adoption across the account. Significant depth and breadth in both academic and community settings. So we expect this will continue to increase in terms of market share. We are not in a position to comment on this.

Just would like to say that this is an area Oh, hi, unmet need and where we are places to see his daddy adoption across of the accounts significant depth and breadth and both academic and community.

So we expect this will continue to increase in terms of market share we're not in a position.

Physicians to come in at this time.

Speaker 5: And thanks, Mike, for the question in terms of.

Mmm. Thanks, Mike further question in terms of.

Speaker 5: the PICLO data. I can't imagine a better foundation on which to build in Platinum-Centative Ovarian Cancer than interim assessments that we've been able to share with respect to PICLO. This is a, just to remind you, this is a heavily pre-treated population of patients with Platinum-Centative Disease. And when we look across the available therapy, which is...

The pickle of data you know I I I I can't imagine a better foundation on which to build in plan insensitive ovarian cancer, then enormous estimates that we've been able to share with respect to Piccolo. This is a just to remind you. This is a.

Heavily pre treated population.

Plan of patients with plan insensitive disease and.

When we look across the.

The available therapy, which is.

Speaker 5: very heterogeneous because there are so few options. We see single agent monotherapy, objective response rates, and the...

Very heterogeneous because there are so few options.

We see single agent mono therapy objected response rates and the.

Speaker 5: high single digits to low double digits. And we see platinum based doublet.

High single digits low double digits.

And we see.

Platinum base Douglas.

Speaker 5: objective response rates anywhere between the high 20s and high 30s. And here we are with an interim assessment of an ongoing study where we expect at least a 48% objective response rate. So this sets a really nice foundation for the continued work of of Merva Texamad and Plano and Centiped Disease.

Objective response rates anywhere between the high twenties, and and high thirties and here, we are with an or an assessment of an ongoing study where we expect at least to 48% objected response rates. So this sets a really nice foundation for the continued work of.

<unk> plan insensitive disease.

Q as a reminder.

Thank you one moment for our next question.

Speaker 1: And our next question coming from the line of Ed Sardaruk with BMO Capital Markets. You're on your cell.

And our next question coming from the line of <unk> interact with BMO capital markets for your line of service.

Speaker 10: Great. Thanks for taking my questions and congrats. I'm continued. Ella here, execution here.

Great. Thanks for taking my questions and congrats continued uhm <unk> execution here.

Speaker 10: Um, maybe on piccolo and thanks for the additional color on the study just wanted to know if you could comment at all on sort of the standard of care duration of response and sort of just.

Maybe piccolo and thanks for the additional color on the study just wanted to know if you could comment at all on the standard of care duration of response and sort of just sort of global sitting expectations from sort of a standard of care perspective for that studying I had a question on.

Speaker 10: sort of level setting expectations from sort of a standard of care perspective for that study.

Speaker 10: Um, I had a question on on Adam 9 as well. Just thinking about sort of some of the recent data we got.

Adam nine as well just thinking about sort of some of the recent data we got <unk> from the truth to make them as in terms of the you know responds dynamics potentially inscrutable scream as versus a non squamous non small cell canceled population. If you could comment at all and sort of the item nine mechanism.

Speaker 10: I'm at Esmo from the TROP2 mechanism. In terms of the, you know, response dynamics potentially and sort of a squamous versus a non-spamous, non-small cell cancer population, if you could comment at all on sort of the item nine mechanism and whether or not they're sort of a preference or a confers preference for for for.

And whether or not they're sort of a preference or put first preference for a particular sort of nausea squamous histology. Thank you.

Speaker 10: particular sort of swamous histology. Thank you.

Speaker 5: Sure, as are this mic. Let me respond to the second question first.

Mmm.

Sure.

This is Mike let me respond to the second question first at.

Speaker 5: I think the long and short of it is that Adam Nine is broadly expressed and we look forward if there's any

The long and the short of it is that Adam nine is broadly expressed and we look for.

If there's any.

Speaker 5: You know, if there's any signal that we see that is distinguishable based on histology when we have that expansion data, we'll obviously be looking forward to sharing that. But at this point, given the broad expression across epithelial cancers, you know, we're continuing to, you know, to look broadly in that cohort.

Yeah, if there's any signal that we see that is distinguishable based on histology when we have that expansion data.

Obviously, Steve looking forward to sharing that bad at this point given the broad expression crossed epithelia all cancers.

We're we're continuing.

To.

To look broadly in that cohort uhm.

Speaker 5: with respect to the first question.

With respect to the first question.

Speaker 5: I just want to reinforce that we're really looking forward.

I just want to reinforce that.

Speaker 5: next year sharing the full data from Piccolo.

Looking forward mid next year sharing the fall data from Piccolo.

Speaker 5: And your questions are really going to be relevant in the context of the specific demographics, even more detailed than what we're able to share today with respect to, for example, more detail around the platinum-free interval in this patient population to be able to better interpret, not just

And and it's your questions are really going to be relevant.

<unk> in the context of the specific demographics even.

More detail than what we were able to share today with respect to for example, more detail around the platinum free interval on this patient population to be able to better interpret not just.

Speaker 5: the interim assessment objective response rate that we're seeing, but also the durability of response and other factors that are going to be important to essentially round out this interim assessment with the full data. So we're really looking forward to that, and like I said, I think we've shared that we expect that in mid-next year.

The interim assessment.

Objected response rate that we're seeing but also.

The ability of response and and other factors that.

That are going to be important to.

Essentially round out this interim assessment with the full data. So we're really looking forward to that and like I said, it and increase shared that we expect that in the next year.

Thank you.

Speaker 1: Thank you, and we'll move on to our next question. Our next question coming from the line up, where is Speaker with Tidi Kao and the Atlanta Sopen?

Thank you one moment my next question.

Next question coming from the line up for a speaker with T D colony line or something.

Speaker 5: Great, congratulations on the progress. Two questions from me. So first on Ella here, I'm just curious, what is the current duration of therapy and how do you expect that I guess to increase in piccolo patients? And the second is maybe kind of get your general thoughts on the competitive product, DS6000 from Daichi. That's an early stage development.

Great Congratulations on a progress two questions for me. So first on our here I'm just curious what is the current duration of therapy and how do you expect I guess to increase and piccolo patient and the second is maybe kind of get your general thoughts on the competitive products T 6000 from Daiichi that's an early stages.

Development.

Speaker 9: Yeah, Boris, the claims data that we have at this point are not sufficient to allow us to project a duration of therapy among the patients that have been treated. You know, as a general rule, what we'd observe is that patients at earlier lines tend to have higher response rates and stay on drug longer. We observed that same phenomenon with the use in in combinations.

Yeah <unk> the claims data that we have at this point are not sufficient to allow us to project duration of therapy among the patient.

Been treated as a general rule, what we observe is that patients in earlier lines tend to have higher response rates and stay on drug longer.

Serve that same phenomenon with the with the used in combination.

<unk>.

Speaker 5: Hi, Boris, it's Mike, and with respect to your second question, yeah, clearly the data you referenced that were presented, I think, last week are interesting. It's a phase one experience. It looks to me, at least from the data, that there's some work to do with respect to identifying the appropriate dose.

Uhm Headboards, it's Mike and with respect to your second question Yeah.

Clearly.

The reference that were presented I think last week.

Are interesting, it's a phase one experience.

It looks to me at least from the data there's some work to do with respect to identifying the appropriate dose.

Speaker 5: It's going to be something that we're going to want to keep an eye on and think about ways in which those data progress, but we're years ahead in terms of the plan of resistance space and and can't believe the plan in sensitive space in terms of where we're at with Ele here.

It's gonna be something network gonna want to keep.

Keep an eye on and think about ways in which.

Those data progress, but uhm.

<unk> ears ahead in terms of the plan resistant space and and Kimberly the plan insensitive space in terms of where we're at with the elegant.

Great. Thanks for taking my question.

Thank you.

Speaker 1: And our next question coming from the line of Brian Cheng with JPMorgan. Your line is open.

Next question coming from the line of Brian Chang with J P. Morgan Your line is open.

Speaker 11: Hey guys, congrats on the quarter and thanks for taking my question this morning.

Hey, guys congrats on the corner and thanks for taking my question. This morning.

Speaker 11: Mark, how should we think about the sales trajectory next year, from the dynamics of patients on combo with Bav and the youth in early line versus this continuation just due to natural progression? How should we think about the trajectory moving forward? And then, you know, too long piccolo, how should we think about the regulatory path look like, you know, pose your piccolo final analysis?

How should we think about the sales trajectory next year, you know from the dynamics of patients on the combo with path that you as an early line versus discontinuation just due to natural progression how should we think about the trajectory moving for it and then you know <unk> how how.

Should we think about the regulatory path look like <unk> final analysis and do you think the final analysis will give you a sufficient my fries for conversation for Lebo expansion next year. Thank you.

Speaker 11: And do you think the final analysis will give you sufficient leverage for conversation for label expansion next year? Thank you.

Excellent I'll start.

Speaker 9: We expect to see continued growth. We will give guidance and conjunction with our earnings call in February of next year when we report out full-year results. But for the reasons that Isabelle articulated in her opening comments, what we see from our market research is increased testing and that trend should continue increasing awareness. Right now, the survival data are not currently in the label and so we can't directly promote that information with the...

We expect to see continued growth, we will give guidance in conjunction with our earnings call in in February of next year. When we report out a full year results, but for.

For the reasons that Isabel articulated in her opening comments.

<unk> you know what we see from our market research is increased testing and that trend should continue increasing awareness right now the survival data are not currently in the label and so we can't directly promote that information with the submission.

The S B L. A and subsequent approval, we'll be able to go to the market with that and what we observe from the market research at this point is with increased education. We also see increased the breadth and depth of prescribing both as it relates to the <unk>.

B as well as in combination we think they're arising treatment rates. So this is you know a new therapy in that area of unmet need.

Speaker 9: pointed out earlier that, you know, this is the first drug.

Pointed out earlier that this is the first drug approved specifically in ovarian cancer and almost the last decade and so they expect expectation here is that treatment rates will increase and then in particular with the Mirasol data, we have the ability to compare and contrast against the standard of care.

Speaker 10: approved specifically in a variant cancer in almost the last decade. And so the expectation here is that treatment rates will increase. And then in particular with the Mirisol data, we have the ability to compare and contrast against the standard of care. And when we do that, what we observed again in the research is an inclination to use the drug earlier in the treatment cascade. And so, you know, we do anticipate these questions over the course of the call in today. And so, you know, what I would say again is that we do expect continued growth, but I think it's also fair to say that coming off of a $100 plus million base, the slope of the curve will not be as steep as it was in the past couple quarters.

Speaker 9: and a variant cancer in almost the last decade. And so the expectation here is that treatment rates will increase. And then in particular with the Mirisol data, we have the ability to compare and contrast against the standard of care. And when we do that, what we observed again in the research is an inclination to use the drug earlier in the treatment cascade. And so, you know, we do anticipate these questions over the course of the call in today. And so...

And when we do that what we observe again in the research is an inclination to use the drug earlier in the treatment Cascade and so we do anticipate these questions over the course of the call in today and and so.

What I would say again is that we do expect continued growth, but I think it's also fair to say that coming off of 100 plus billion dollar base. The slope of the curve will not be as the visit was in the in the past couple of quarters.

Speaker 5: And, Mike, regarding.

And can I have my regarding.

Speaker 5: Yeah, this is Mike, regarding your second question.

Yeah. This is Mike regarding your yeah. Your second question.

Speaker 5: So first of all, let's just keep in mind where we're at, right? This is a foundational data that will unequivocally be clinically meaningful in this patient population.

So first of all let's just keep in mind.

At rate.

This is foundational data that will unequivocally be clinically meaningful in this patient population.

Speaker 5: and the reason that the full data set

The the reason that the full dataset won't be available until mid 2024 is because of the importance of presenting mature durability of response data.

Speaker 5: Won't be available until mid 2024 is because

Speaker 5: of the importance of presenting mature durability of response data. And just to keep in mind, the last patient was enrolled in this study.

And just to keep in mind the last patient was enrolled in this study.

Speaker 5: early this year. So it gives you a sense of the importance of what that mature responsibility data will be.

Early this year.

It gives you a sense of.

Of the importance of of of of.

What that mature response to our ability data will be.

Speaker 5: I fully expect, given what we know today, that these data will support compendial listening eventually when we see the full data. And I'd like to reserve judgment on dialogue with regulatory authorities until we have that full data because there's just no way to put...

Expect given what we know today.

These data will support <unk> eventually when we see the full data and I'd like to reserve judgment on a dialogue with regulatory authorities until we have that that full data because there's just no.

No way to put.

Speaker 5: and overall objective response rate into context with that, the durability of response.

Yeah, an overall objective response rate into context with that the durability of response.

Alright. This is very helpful. Thank you.

Speaker 1: Thank you. And our next question coming from the line of Alexandra Ramsey with William Blair. Your line is open.

Thank you.

Next question coming from the liner Alexandra Ramsey with William Blair Yolanda shopping.

Speaker 12: Everyone thinks I'm going to get my questions and congrats on all the progress is quarter. So two quick questions, I guess first I'll take a look. About 48 response rate that you mentioned, they'll present potentially present a full data. I just want to confirm that that's a confirmed 48% response rate.

Hi, everyone. Thanks, so much for taking my questions and congrats on Congress this corner.

So two quick question Uhm, I guess first X amount uhm that 48 response rate that you mentioned.

Percent potential for Senator for data just wanted to confirm that that's a confirmed 40% response rate.

Speaker 12: Looking at the Miracil data present earlier as go, it appears that the part tree patients actually responded better than the part my patients. So I was just wondering if you could provide some color on why that might be the case.

And then.

Looking at the mirror something present earlier.

And it appears that the park treat patients actually responded patterns and department <unk>.

So I was just wondering if you could provide some color on why that might be the case. Thanks. So much.

Speaker 5: Yeah, so this is Mike regarding your second question. It's important in that subset analysis to look at the demographics of the patient populations when the Miracel data set is parsed.

Mmm Yeah. So this is Mike regarding your second question, it's important in that subset analysis to look at the the demographics of the patient populations when the Mirasol data set is parsed by.

Speaker 5: by prior exposure to Park and Hibiter or not.

Prior exposure Department Hemmeter are not we tried to point that out in the presentation and I have encouraged you to go back and look at that but the long and the short of it is there are there are some differences that are more apparent and.

Speaker 5: We tried to point that out in the presentation. And I'd encourage you to go back and look at that. But the long and short of it is there are some differences that are more apparent in the part of the naive population. And generally in terms of outcomes, it's not surprising necessarily that we see slightly better outcomes and patients that are...

90 population and.

And generally in terms of outcomes, it's not surprising necessarily that we see slightly better outcomes.

Outcomes in patients that are.

Speaker 5: appropriate based on the molecule profiling for park inhibitors.

Appropriate based on their Nokia profiling for carpet inhibitors.

Speaker 5: And with respect to the first question, yeah. So this is an inter-assessment. It was a planned inter-assessment following full enrollment.

And with respect to the first question. Yeah. So this is an enormous assessment. It was planned an interim assessment finally fall enrollment and.

Speaker 5: and these data are confirmed. The one caveat I'll say, and I think Mark mentioned this as well, is that this is an ongoing trial, right, with patients, a number of patients that are still receiving therapy. And so,

Data are confirmed.

The one caveat all saying I think Mark mentioned this as well is that this is an ongoing trial right with patients a number of patients that are still receiving therapy and so.

Speaker 5: in the parlance of a clinical researcher, we confirm the data when we share something like this, but of course,

Parlance of a clinical researcher we we confirm the data when we share something like this but of course, we need to reserve the.

Speaker 5: We need to reserve the caveat that when the full data are presented in next year, that in the process of providing this full data, there could be minor.

The caveat that when the when the full data are presented mid next year.

Sure.

That in the process of providing us full data there could be in a minor.

Speaker 5: You know, minor shifts in the data, and that's why we're really clear to talk about an objective response rate of at least 48.

Minor shifts and in the data and that's why we're really clear to talk about an objective response rate of at least 48 per cent.

Speaker 5: Okay, no, that makes sense. And so you are seeing counter-ability increase over time. It sounds like it based on how long people have been on treatment, but just confirming that. Yeah, I mean, that's the issue of the maturity of the duration of responses exactly why we're providing some guidance today that we would expect the full data in 2024.

Okay.

That makes sense since you are seeing hunter adults increase over time, it sounds like a based on how long people with <unk>.

But just confirming that yeah, I mean that that that the the the.

The issue of.

Maturity of the of the duration of response is exactly why we're providing some guidance today that we would expect the full data and then 2024.

Perfect. Thanks, so much.

Speaker 1: Thank you. And our next question coming from the line of Peter Lawson with Barkley, Síulenisol.

Thank you next question coming from the line of Peter Lawson with Barclays seal on his cell phone.

Speaker 13: Thanks for taking my questions. Just going back to your comments around Dages, CDHC, ADC. Just curious on what do you thought the data are? And if kind of...

Thanks for taking my questions, just just going back to your comment around <unk> CH CH 86.

Just curious on.

What do you feel the data in this kind of stuff.

Response rate and durability kind of holds up.

How you think physicians will.

Pick between.

<unk> molecule in Illinois, and then.

Particularly if I could just go back to that 40% mean, there's kind of unconfirmed there and it should get to about 48% over it at 48 cents or any any details around that.

Speaker 13: The 48% mean there's kind of unconfirms there and it should get to above 48% or at 48%.

Kind of finding a detailed poetry you made the grade.

Speaker 5: Yeah, well, I'll say to the second point, which kind of relates to the prior question is that, we do see late responses.

Yeah.

Yeah, well I'll say to the second point, what's kind of relates to the prior question is that.

We do see we do see late.

Speaker 5: you know, in our data sets generally. And as I mentioned there are a number of patients that remain on Marvatoxam abs.

Responses.

Datasets generally.

And as I mentioned, there are a number of patients that remain on my Rituxan ma'am.

Speaker 5: So at this interim assessment, we can confidently say that we see an objective response rate of 48%, but we just need to be cognizant of those number of patients that remain on therapy. So could the objective response rate at the final date be higher? Yes, it could be. It could be higher.

So at this interim assessment, we can confident Lee.

Say that we see an objective response rate of 48%, but we just need to be cognizant of that was a number of patients that remain on therapy. So could be objected response rate at the final day to be higher yes, it could be it could be higher.

Speaker 5: With respect to your first question, it's so conjectural. I mean, like I said, we've got a phase one molecule that has a really interesting early signal, like I said earlier.

With respect to your first question. It's so conjectural I mean like I said, we've we've got a phase one molecule that.

Has a really interesting early signal like I said earlier it.

Speaker 5: It looks like to me we're trying to figure out those that I think there were some grade five interstitial lung disease related death. So.

It looks like to me, we're trying to figure out dose then I think there was some grade five interstitial lung disease related death.

So.

Speaker 5: Gosh, I hope for patients that we're able to work through that. And it becomes potentially someday, I mean, you've got the therapy and ovarian cancer. But I think it's a little premature from where I said to try to hypothesize about how physicians are going to make treatment choices compared to a medicine that has demonstrated survival benefit and platinum resistant ovarian cancer. Thanks for the additional.

Gosh I hope for patients that we're able to work through that and it becomes potentially someday a meaningful therapy and ovarian cancer, but I think it's a little premature from where I sit to try to hypothesize about how physicians are gonna make treatment choices compared to.

Medicine that has demonstrated survival benefit and phone number system ovarian cancer.

Thanks for the additional details what's the overlap between <unk> and C. D H says.

Speaker 5: Yeah, you know, we're looking hard to understand that. I can't give you any numbers today, but when we have a better understanding of that, of course, we'll be able to share that.

Yeah, we're looking hard to understand that I I can't give you any number sir today, but when we have a better understanding of that of course will be able to to share that.

Perfect. Thanks, so much progress on the court.

Thank you.

Speaker 1: Thank you. And our next question coming from the line of Kailishi with Jeffrey Sealon is now open.

Thank you.

Next question coming from the line up Kelly's Shane with Jeffrey Skilling is now open.

Speaker 14: Congrats on another great quarter and thank you for taking my questions that I have two. Firstly, on the regulatory approval, will you be able to share your launch strategy in Europe at a moment? And also, how should we consider the cost associated with the launch?

Can write down an adequate Carter and thank you for taking my questions that I have to firstly on your mental nature my approval, you'll be able to share your laundry strategy in Europe at the moment and also how should I wait <unk> associate that with their lunch and another.

Speaker 14: And another question regarding the item 9 program. So for the upcoming update in NAMMSOSA 1 Cancer, could you share what the interim analysis is based on? Is it a response rate or the durability of the sound? Thank you.

Question regarding that item nine program.

For the upcoming <unk>, how long 10, Sir can you share what interim analysis is based on.

That sounds great.

<unk>. Thank you.

Speaker 5: I'll just briefly respond to the second question, and I think Mark or Isabel may tackle your question about UROP. So this is a cohort expansion of a phase one study. And so

I'll just briefly respond to the second question and I think the market is about my talk with your question about Europe.

So this is a covered expansion of the phase one study and so.

Speaker 5: It's essentially thinking about it as sort of fully enrolling that cohort and having this sufficient data to be able to share that in totality. It's nothing really more complicated than that. And patients remain in the cohort. It's just prudent to on therapy. It's prudent to wait for that to mature. And we look forward to sharing those data.

It's.

It's essentially.

Think about it as sort of fully enrolling that cohort and having a sufficient.

Data to be able to share that in totality, it's not nothing really more complicated than <unk> than that in his patients remain.

In the cohort.

It's just prudent to.

On therapy is prudent to to wait for that for that to mature and we look forward to sharing those data next year.

Speaker 9: Thanks. And so in terms of Europe , I'll start and then ask, is about to comment further, but we were very pleased to an ask last week that the EMA had validated our marketing authorization, the application. And we think that sets us up very nicely for an approval late next year. In terms of the launch sequence, we're on the ground already in Europe with established headquarters in Switzerland and a small stack to support the key functions around market access regulatory. And the like are starting to build a team to support initial sales in Germany. And then there'll be subsequent countries added on as we go forward. And then I'll let is about talk a little bit about the market and overall the comment here is that we can address this market with a modest incremental investment for the business. But maybe just talk a little bit about the dynamics.

Great. Thanks, and so in terms of Europe are starting and ask Isabelle to comment further, but we're very pleased to announce last week that the EMEA validated our marketing authorization the application and we think that sets us up very nicely for an approval late next year.

In terms of the launch sequence, where we are on the ground already in Europe was established headquarters in in Switzerland, and a small stack to support the key functions around market access regulatory and and the like and are starting to build a T.

<unk> to support initial sales and in Germany, and then there'll be subsequent countries added on as as we go forward and then I'll, let Isabel talk a little bit about the market and overall the comment here is that we can address this market with a modest incremental investment for the business.

But maybe just talk a little bit about the dynamics there, yes, ma'am. Thank you well, let me share previously name Mark in Europe is highly concentrated and really the majority of defence. It's 55 scientists account for about 80% of the patients there so as mark alluded to with a small embarrassed man we have.

Speaker 4: Yes, Mark, thank you. Well, we have shared previously the marketing Europe is highly concentrated and really the majority of the cent, the cent is a comfort about 80% of the patients there. So as Mark alluded to with a small investment, we are able to reach this customer.

Speaker 15: We also started on very our engagement. And as you saw, we presented as ESCO and ESMO and we have very strong relationships with KOS in Europe that are really excited to have this therapy available to them in a tank swim. And of course, our very much supporting our efforts in this. In addition to that, we are giving up our team in suit and Germany in other countries. And we are very excited to start.

Able to reach the customer.

We also had it started I'll pay our engagement and at <unk> and <unk> and we have very strong relationships with K O as in Europe that are really excited to have this therapy available to them.

<unk> and of course I.

Very much support in our <unk>. In addition to that we are getting an app or theme ensued in Germany, and other countries and <unk> alright, <unk> preparations to basically replicate the success of the launch that we have seen in the <unk>.

Speaker 4: Our microbeach test, our preparations to basically replicate the successes of the launch that we had seen in the US.

Speaker 9: One other point to add to that, which is Kelly R. Physician base there has tremendous experience with the drug already. So when we look at Mirrothal, when we look at Saraya, more than 70% of the patients were enrolled outside of the United States and the vast majority of those were enrolled in Europe . And so this is a group of physicians that has already significant experience with the drug. So we're excited about our prospects there.

And one other point to add to that which is.

<unk>.

Physician base, there has tremendous experience with the drug already so when we look at Mirasol, we look at sorry more than 70% of the patients were enrolled outside of the United States and the vast majority of those were enrolled in Europe and so this is a group of physicians that has already significant.

Experience with with the drugs. So we're excited about our prospects there.

Perfect. Thanks.

Sir.

Speaker 1: Thank you. And our next question coming from the line up.

Thank you and our next question coming from the lineup.

Speaker 1: Asika, can ward you in from through us, you'll on a self.

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<unk> from <unk>.

Speaker 10: Hi guys, good morning. Thanks for taking my questions. First up, congrats on another robust quarter of those guys, especially coming in line with aggressive vice-ad expectation. That's great to see.

Hi, guys. Good morning, Thanks for taking my questions first off congrats on another robust <unk>.

Especially coming in line with your <unk> advice that expectation that's great to see totally understand that you can't be too specific on off label use here, but can you. Please give us some sort of.

Speaker 16: Tony, I understand that you can't be too specific on off-level years here, but can you at least give us some sort of a bit of color here on what off-level population is the largest in what you're seeing so far and what is growing the most rapidly?

<unk> on what off level population is the largest and what you're seeing sofa and what is growing most rapidly.

Speaker 16: I think that could just be a little helpful here for us as we're tweaking our models here. And then on piccolo, good to hear about what the ORR is changing at.

I think that could just be a little helpful. Here for US is Trisha models here Uhm and then on P. Colo good to hear about what they are always changing yet, but what about duration of response as you do.

Speaker 16: But what about duration of response? As you're giving us what the statistical bars are, can you tell us what you need to beat for DOR?

Given us what the statistical bars or can you tell us what you need to beat for D. U R. And then I'll also add a previous call. The thank you.

Speaker 16: And I'll also add in previous calls, I think Anna and some of you guys had mentioned that.

Speaker 16: Suggested that that this could be also an area where where people could look good. So just want to see if you feel confident about that as well. Now that you're seeing more of the data in house and then last.

So if you guys have mentioned that suggested that that this could be Austin area, where where where people could look good. So just wanted to see if you feel confident about that as well now did you see more data in your house and then lastly.

Speaker 16: Do you need to publicly present PICOLO in order to discuss it with the NCCN, or can you share that with the NCCN ahead of a public presentation? Thanks.

Do you need to publicly present piccolo in order to discuss it with the N. C. C. N. All can you share that with <unk> ahead of a public presentation. Thanks.

Speaker 17: So let me start with the market question and you can talk about Tickleau and NCCN. So...

So let me start with Mark a question and you can talk about piccolo and CCN. So.

Speaker 9: In terms of discretionary use of this product outside the label, the first thing to keep in mind is that our label is platinum resistant ovarian cancer and patients who receive one to three prior lines of therapy who are FR alpha positive. So

Terms of discretionary use this product outside of the <unk>. The first thing to keep in mind is that our label as platinum resistance ovarian cancer.

<unk>, who received one to three prior lines of therapy, who are F. R. Alpha positive. So what we observed very early on was that consistent with the N. C. C. N guidelines that physicians will using the product and later line patients so beyond.

Speaker 17: What we observed very early on was that, consistent with the NCCN guidelines, that physicians were using the product in later-line patients, so beyond a patient who'd had three prior therapies, and that continues as we speak.

A patient who had three prior therapies and that that continues at as as we speak we've been observed that.

Speaker 9: Um, we then observed that um

Speaker 9: There are patients that might not qualify as FR-alpha high who nonetheless are getting therapy as monotherapy where the FR-alpha expression is close to what would be considered FR-alpha high. Just as a reminder to folks.

There are patients who might not be that might not qualified as F. R. Alpha hi, Nonetheless are getting therapy as mono therapy, where the F. R outfit expression as close to what would be considered F. R out behind just as a reminder to folks.

F R. I a a high is defined as 75% of the patients sent tumor sample expressing F. R. Alpha at two plus intensity staining and so when a pathology report comes back from our labs and has to read out some one is positive or negative based on whether.

Speaker 17: and whether it meets that cut point of 75 at two plus intensity standing. But also there's a numerical score with respect to the expression level. So it's stated in five percentage points increments, so 75, 80, 85, up to 100, and then downwards for 70, 65, and so on. What we hear anecdotally through market research in our advisory boards is that many physicians with a 70% reading will initiate monotherapy. As the FR-alpha expression levels go down, there's the opportunity to engage around combination use. And again, the NCCN guidelines are supportive here where they include use of the product for patients with medium and low levels of expression. And so we, as I said, we see use in later lines. It's a little hard to, we can't sort of match a patient who had, you know, a 70% level of expression with monotherapy used at this point, the data aren't, we're not able to from a data perspective to match those two things. And then we do see, you know,

It needs that cut point of 75 at two plus intensity standing, but also there's a numerical score with respect to the the expression level. So it's David and five percentage points increments. So 70, 580 85 up to 100, and then downwards for 70 265 and so on.

What we hear anecdotally too market research and our advisory boards is that many physicians with a 70 per cent reading will initiate a mono therapy as the F. R off expression levels go down there's the opportunity to gauge around combination used in again.

The <unk> guidelines are supportive here, where they includes use of the product for patients with medium and low levels of of expression. So we as I said, we see use and later lines, it's a little hard to we can't sort of <unk>.

Speaker 9: uh use um in later lines uh it's a little hard to we can't sort of match

Speaker 9: a patient who had, you know, a 70% level of expression with monotherapy used at this point. The data aren't, we're not able to from a data perspective to match those two things. And then we do see, you know, an increasing use of combination and it comes through most prominently in our market research relative to the claims data which lag a little bit. And, you know, I think.

Match, a patient who had a 70 per cent level of expression with mono therapy use at this point the the data on we're not able to from a data perspective to match those two things and then we do see you know and increasing use of combination and it comes through most prominent.

<unk> and our market research relative to the claims data, which which lag a little bit and I think a number of of you on the call have.

Speaker 9: A number of you on the call have produced your own sort of market research studies.

Produced your own sort of market research studies.

Speaker 15: Let's show, you know, both existing and anticipated increasing use of combination therapy. I don't know if you want to add anything to that. Yes, I just want to say awareness of NCCN guidelines has increased and it has been included in some of the pathways to some of the centers and NCCN guidelines are silenced around high, medium, low and monotherapy in addition to listing the value of the combination. So.

Let's show you know both existing and anticipated increasing use of combination therapy I don't know if you want to add anything to that.

Yes, I just wanted to say awareness of S. C. N guidelines has increased and it has been included in some of the pathway to San Jose centers.

<unk>, Hi, <unk> mono therapy.

<unk> listen the value of the combination so.

Speaker 15: In addition to being used in later lines of therapy, yes, we see use on mediums and lows, particularly in combination.

In addition to being using later lines of therapies, yes, we see use.

Medium and particular inconvenience.

And this is Mike with respect to your <unk>.

Speaker 5: second, third, and fourth questions. Let me make a point about this patient population that perhaps I haven't been quite explicit enough about. But when a patient with natural history who has still platinum-sensitive disease in third or subsequent lines, there's an important

Second third and fourth questions let.

Let me make a point about this patient population that.

Perhaps I haven't been quite explicit about but patient with natural history has still platinum sensitive disease in third or subsequent mind there is an important.

Speaker 5: dichotomization around the relative platinum sensitivity that a clinician is thinking about when they think about appropriate therapy at this stage. And...

Dichotomous Asian.

Around the route the relative platinum sensitivity that a clinician is thinking about when they think of that appropriate therapy at this stage and.

Speaker 5: And that's important as we think about the full data when we see those data next year, because the durability of response, just like the objective response rate, are going to be influenced whether the patient population has a platinum-free interval that's relatively short versus a platinum-free interval that's relatively long.

And and that's important as we think about the full data when we see those data next year.

Cause.

The durability of response, just like the objective response rate are going to be influenced whether the patient population has a platinum free interval, that's relatively short versus a platinum free interval that's relatively long.

Speaker 5: and you can imagine or hypothesize that if the clinician is even considering a monotherapy non-platinum agent in a clinical trial like mervituximab, that when we see the final data, I would expect.

And you can imagine our hypothesis that is the clinician is even considering a mono therapy non platinum agent in a clinical trial like more of a toxin that that when we see the final data I would expect that we have a substantial proportion of patients that have a short relatively short plattner.

Speaker 5: that we have a substantial proportion of patients that have a short, relatively short platinum-free interval. And that's really important to help interpret the full data set, along with the proportion of patients.

I'm free interval and that's really important to help interpret the full dataset along with the proportion of patients that have prior exposure to harp inhibitors in bevacizumab. So it's all of those clinical factors and demographics that need to be incorporated into the interpretation of the data.

Speaker 5: that have prior exposure to parping hivators and bevices and maps. So it's all of those clinical factors and demographic.

Speaker 5: that need to be incorporated into the interpretation of the data to be able to put the data into context with respect to the objective response rate and durability.

Be able to.

Put the data into context with respect to the objective response rate and durability of response.

Speaker 5: And with respect to your question around NCCN, I think a working assumption should be that the NCCN is looking for published data sets to review in the context of updating their guidelines. Awesome, thanks for taking.

And with respect to your question around N C. C. N I think a working assumption should be that the M. C. C and is looking for published datasets to review in the context of updating their guidelines.

Awesome. Thanks for taking all my questions I appreciate it.

Speaker 1: I think we have time for one more question. Certainly. Our last questioner coming from the line of Lee Chen with HC Wainwright. Your line is open. Hi. This is Lee Chen.

Sure.

Thank you have a time for one more question.

Alright last question are coming from the line of <unk> with H C. When Ryan your line or something.

Hi, This is <unk>, Okay can you hear me okay.

Speaker 12: So, just upon the conversion from accelerated approval of Ella here to full approval, I believe that Takeda, under the license agreement with Takeda, there's additional payment. Can you provide more details on that?

Yep.

So just a pound of <unk> from accelerated approval up here too full approval I believe that a cheetah.

Under the license agreement with Turkey that there's additional payment could you provide more details on that.

Speaker 17: So, I can comment on the Huadong license, and that does call for additional milestone payments upon full approval. I won't comment on the exact amount of those. I would have to get back to you on the Takeda license.

So I can comment on the <unk> license and that does call for additional milestone payments upon full approval won't comment on the on the exact amount of those I would have to get back to you on the on the Takeda license.

Okay.

Okay.

Speaker 17: Okay. Well, thank you all for joining us today. Obviously, we are very pleased with the progress in the business. We've got an important and growing product. We look forward to continued progress there as we look to expand geographically and also moving this drug into earlier lines of therapy. We've got an important second pivotal program ongoing as we speak, an exciting portfolio, and you'll hear more from us as we go forward about reinvesting in the pipeline and our research capabilities. We think that ADCs are an important and growing class of therapeutics.

Okay, well. Thank you all for joining US today, obviously, we are very pleased with the progress in the business. We've got an important and growing product. We look forward to continued progress. There. So would you look to expand geographically and also moving this drug into earlier.

Means of therapy got an important second pivotal program ongoing as we speak and exciting portfolio and you'll hear more from US as we go forward about reinvesting in in the pipeline in our research capabilities, we think that adc's aren't important and growing class of.

Speaker 17: we've got a highly differentiated skill set as it relates to that class of therapy. So again, look forward to keeping you updated and we'll see many of you at ASH. Thanks.

<unk>, we've got a highly differentiated skills set as it as it relates to those that class of therapy. So.

Look forward to keeping you updated and we'll see many of you would ash. Thanks.

Speaker 1: Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.

Please sign gentlemen conference for today. Thank you for your participation you may now disconnect.

Speaker 18: You

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