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ImmunoGen, Inc. (NASDAQ: IMGN) FY 2021 earnings name dated Feb. 25, 2022
Company Individuals:
Courtney O’Konek — Senior Director of Company Communications and Investor Relations
Mark Enyedy — President and Chief Government Officer
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Susan Altschuller — Senior Vice President and Chief Monetary Officer
Kristen Harrington-Smith — Senior Vice President and Chief Industrial Officer
Analysts:
John Newman — Canaccord — Analyst
Yige Guo — Guggenheim Securities — Analyst
Etzer Darout — BMO Capital Markets — Analyst
Boris Peaker — Cowen — Analyst
Andy Hsieh — William Blair — Analyst
Han — Jefferies — Analyst
Kennen MacKay — RBC Capital — Analyst
Jessica Fye — JPMorgan — Analyst
Earl De — H.C. Wainwright — Analyst
Joe Catanzaro — Piper Sandler — Analyst
Jonathan Chang — SVB Leerink — Analyst
Presentation:
Operator
Good morning, women and gents and welcome to ImmunoGen’s Fourth Quarter and Full-year 2021 Monetary and Working Outcomes Convention Name. [Operator Instructions]
Presently, I’d like to show the decision over to Courtney O’Konek, Senior Director of Company Communications. Please go forward.
Courtney O’Konek — Senior Director of Company Communications and Investor Relations
Good morning and thanks for becoming a member of at this time’s name. Earlier at this time, we issued a press launch that features a abstract of our current progress and fourth quarter and full-year 2021 monetary outcomes. This press launch and a recording of this name could be discovered beneath the Traders and Media part of our web site at immunogen.com. With me at this time are Mark Enyedy, our President and CEO; Anna Berkenblit, our Chief Medical Officer; and Susan Altschuller, our CFO; Kristen Harrington-Smith, our Chief Industrial Officer can even be a part of us for Q&A.
Throughout at this time’s name, we are going to evaluation current accomplishments for the enterprise, our monetary outcomes and spotlight upcoming anticipated occasions. We’ll use forward-looking statements with respect to our enterprise technique, the event and good thing about our product candidates, the design of our medical trials, the presentation of medical trial knowledge for our product candidates, the anticipated timing of medical trials and regulatory submissions to the FDA for sure product candidates, the anticipated business launch for sure product candidates, monetary steering and our money runway.
Every forward-looking assertion is topic to dangers and uncertainties that would trigger our precise outcomes to vary materially from such statements. These dangers and uncertainties embrace these described in our press launch issued this morning and within the Danger Issue part of our most up-to-date annual report on Kind 10-Okay and our different SEC filings, which can be found at sec.gov and on our web site at immunogen.com. These forward-looking statements and this presentation communicate solely as of the unique date of this name and we undertake no obligation to replace or revise any of those statements.
With that, I’ll flip the decision over to Mark.
Mark Enyedy — President and Chief Government Officer
Good morning, everybody and thanks for becoming a member of us at this time. 2021 was a productive 12 months for ImmunoGen, with vital progress throughout the enterprise as we transfer in the direction of our goal of turning into a completely built-in oncology firm. Particularly, we delivered resoundingly optimistic leads to SORAYA, our pivotal examine for mirvetuximab in ovarian most cancers, generated compelling knowledge with IMGN632 and AML, superior our earlier-stage packages, established a plan to reignite our analysis engine, laid the groundwork to help our first business launch and executed the one largest financing within the historical past of the corporate.
With this progress, we’ve generated vital momentum within the enterprise as we entered 2022. To broaden on these factors, beginning with our lead program, Mirvetuximab Soravtansine in ovarian most cancers. Our high precedence this 12 months is to achieve accelerated approval for mirvetuximab as a monotherapy in sufferers with folate receptor alpha optimistic platinum-resistant illness. To this finish, we imagine the optimistic high line SORAYA knowledge reported in late November place us for preliminary approval on this setting with vital unmet want.
We’re on monitor to submit the BLA for mirvetuximab by the tip of this quarter and are getting ready for a possible accelerated approval and launch within the second half of the 12 months. We additionally anticipate to generate knowledge from our confirmatory MIRASOL trial within the third quarter, which is meant to help full approval. As a part of our complete technique to maneuver mirvetuximab into broader affected person populations and develop into the mix agent of selection in ovarian most cancers, we’ve designed plenty of extra company-sponsored research and in parallel are supporting investigator-sponsored trials for mirvetuximab, which Anna will talk about in additional element shortly within the name.
In line with advancing the mirvetuximab program in the direction of regulatory approval, we started constructing our business and medical affairs organizations now led by our Chief Industrial Officer, Kristen Harrington-Smith and our Head of Medical Affairs, Dr. Mimi Huizinga. Launch preparations for mirvetuximab are properly underway and are centered on 4 key priorities, redefining expectations from optimistic outcomes with mirvetuximab in platinum-resistant ovarian most cancers, supporting adoption of early folate receptor alpha testing and establishing requirements for in-house and centralized testing, guaranteeing optimistic doctor and affected person experiences by way of tailor-made schooling and steering for affected person administration and in search of broad payer entry and reimbursement and delivering a seamless affected person expertise.
We’re off to a powerful begin constructing best-in-class gross sales, advertising and medical schooling groups and have most just lately added our Head of Gross sales. Our second program, pivekimab sunirine previously referred to as IMGN632 is progressing properly. We’ve superior our pivotal CADENZA examine in BPDCN and anticipate high line knowledge within the frontline cohort within the second half of this 12 months. Along with BPDCN, we have been happy to current knowledge from the triple routine evaluating PVAC together with azacitidine and Venclexta in relapsed/refractory AML throughout an oral session at ASH and are inspired by the protection profile and efficacy noticed, significantly within the greater depth cohorts.
Primarily based on these knowledge, we’ve initiated an enlargement cohort for the triplet relapsed sufferers and anticipate to maneuver into frontline sufferers through the 12 months. Relating to our earlier-stage portfolio, dose escalation continues within the Part one trial of IMGC936, our first-in-class ADAM9 concentrating on ADC which we’re co-developing with MacroGenics in a number of stable tumor varieties and anticipate sharing knowledge from this program later this 12 months. We additionally submitted the IND for IMGN151, our next-generation antifolate receptor alpha ADC. As a result of a delay in drug product manufacturing at our vendor, FDA positioned a maintain on our IND utility pending responses to some CMC-related info request.
We’re producing the information responsive to those requests and sit up for enrolling our first affected person following submission of this info to the company. Turning to enterprise improvement, we have been happy to announce a multi-target international licensing cope with Eli Lilly earlier this month. This deal demonstrates the energy of our know-how and management in ADCs and generate worth from our mental property round our proprietary Camptothecin platform.
Lastly, we accomplished an upsized follow-on providing that generated roughly $295 million in gross proceeds within the fourth quarter and we ended the 12 months with over $475 million in money. These funds along with product and collaboration revenues will help the enterprise by way of the preliminary launch of mirvetuximab and different materials inflection factors into 2024.
With that, I’ll flip the decision over to Anna to supply some extra colour on our medical packages. Anna?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Thanks, Mark. We’re extraordinarily happy by the optimistic high line outcomes from our pivotal SORAYA trial. Recall that regardless of advances within the frontline and platinum-sensitive setting, most sufferers with ovarian most cancers ultimately relapsed with platinum-resistant illness. Remedy choice for platinum-resistant ovarian most cancers are restricted, consisting primarily of single-agent chemotherapy, which has restricted exercise with goal response charges starting from 4% to 13% in appreciable toxicities.
Having aligned with FDA on the substantial unmet want on this inhabitants, SORAYA was designed as a single-arm examine of mirvetuximab in sufferers with platinum-resistant ovarian most cancers, whose tumors specific excessive ranges of folate receptor alpha and who’ve been handled with one to 3 prior strains of remedy, together with prior bevacizumab. The first endpoint of confirmed goal response charge or ORR, as assessed by investigator, was 32.4%, properly over double the anticipated response with single-agent chemotherapy.
5 of the responses have been full responses, which doesn’t occur fairly often with out there remedy in platinum-resistant illness. Median period of response or DOR is a key secondary endpoint and was 5.9 months as of the information cutoff on November sixteenth, 2021, with practically half of the responders nonetheless receiving mirvetuximab at the moment, the period of response continues to evolve. These outcomes are significantly encouraging in mild of the closely pretreated inhabitants, by which 51% of sufferers had three prior strains of remedy.
All sufferers obtained prior bevacizumab and 48% had obtained a previous PARP inhibitor. Turning to security. The profile in SORAYA is in keeping with the recognized security of mirvetuximab, which has now been studied in over 800 sufferers. The most typical antagonistic occasions have been low grade, reversible ocular and GI occasions, managed with supportive care and dose modifications if wanted. The tolerability of mirvetuximab is demonstrated by the low 7% discontinuation charge for treatment-related antagonistic occasions, together with only one affected person in SORAYA discontinuing for an ocular antagonistic occasion.
No corneal ulcers or perforation have been reported. As in prior research, the ocular occasions have been predictable, manageable and reversible. Trying forward, Dr. Erso Amadalonas will current the total SORAYA knowledge set at SGO through the plenary late-breaking summary session on Saturday, March nineteenth. Knowledge will embrace up to date period of response and key subgroup analyses, together with sufferers with three prior strains of remedy and people who obtained a previous PARP inhibitor.
Development-free survival knowledge can even be introduced. As talked about, we’re on monitor to submit the BLA for mirvetuximab earlier than the tip of the primary quarter in help of potential accelerated approval later this 12 months. In help of full approval, the confirmatory neurofil examine of mirvetuximab is predicted to readout within the third quarter of 2022. We additionally proceed to enroll sufferers in PICCOLO, a single-arm examine of mirvetuximab monotherapy in roughly 75 sufferers with folate receptor alpha excessive recurrent platinum-sensitive ovarian most cancers meant to help label enlargement.
PICCOLO was designed to handle the growing unmet want for an efficient nonplatinum choice in later strains of platinum-sensitive illness. With an total response charge of 64%, our Part one knowledge present potential for mirvetuximab on this affected person inhabitants. We now have formalized our technique to place mirvetuximab as the mix agent of selection with compelling knowledge from the mirvetuximab plus bevacizumab doublet in sufferers with folate receptor alpha excessive recurrent ovarian most cancers, we anticipate to achieve compendia itemizing for this mix in shut proximity to the preliminary monotherapy approval of mirvetuximab.
These knowledge additionally help our design of GLORIOSA, a possible label-enabling Part three examine within the second-line platinum-sensitive upkeep setting. A couple of third of second-line platinum-sensitive sufferers obtain a platinum doublet plus bevacizumab adopted by bevacizumab upkeep. The addition of bevacizumab to a platinum doublet offers an total modest enchancment in PFS of roughly three to 4 months on this setting, highlighting the constraints of accessible remedy.
GLORIOSA is designed to judge the PFS good thing about mirvetuximab plus bepapizumab upkeep versus bevacizumab upkeep alone in all sufferers who haven’t progressed following completion of their platinum doublet plus bepapizumab. Roughly 440 sufferers will probably be randomized to both mirvetuximab plus bevacizumab or bevacizumab alone for upkeep. The first endpoint is progression-free survival, secondary endpoints embrace total survival and total response charge. We anticipate initiating GLORIOSA within the second quarter of this 12 months.
Given the promising exercise we’ve seen with the mirvetuximab plus carboplatin improvement in Part I dose escalation in recurrent platinum-sensitive illness throughout a variety of folate receptor alpha expression with an ORR of 80% and median period response of 24 months in FR-alpha medium and excessive sufferers, we just lately introduced the deliberate initiation of Trial 0420. Trial 0420 is a single-arm Part two examine of mirvetuximab plus carboplatin, adopted by mirvetuximab continuation in roughly 110 sufferers with folate receptor alpha low, medium or excessive platinum-sensitive ovarian most cancers.
The information from this examine will inform our path to registration on this setting. Transferring to pivekimab sunirine, our CD123 concentrating on ADC. We introduced preliminary security and efficacy findings from the Part 1/2 examine of pivekimab together with azacitidine and venetoclax in sufferers with relapsed refractory AML in an oral session at ASH in December. Demonstrating an ORR of 48% in all relapsed/refractory AML sufferers, these knowledge are encouraging, significantly in greater depth cohort, the place we noticed greater response charges, together with an ORR of 59% and a 38% composite full remission charge.
Importantly, the pivekimab triplet demonstrated no tumor lysis syndrome, veno-occlusive illness, capillary leak or cytokine launch. These knowledge reinforce the potential of pivekimab as a brand new mixture remedy for AML, which sadly is characterised by core outcomes regardless of out there therapies. We now have opened an enlargement cohort in relapsed AML sufferers and plan to provoke a frontline enlargement cohort later this 12 months. Additionally at ASH, we introduced pivekimab monotherapy knowledge that includes [Indecipherable] from three frontline BPDCN sufferers in a poster session.
All three sufferers achieved medical full remission and pivekimab was related to restricted grade three or higher treatment-related antagonistic occasions and no capillary leak syndrome. We proceed to enroll sufferers within the US and Europe in CADENZA, our pivotal Part II examine in frontline and relapsed/refractory BPDCN, anticipate high line knowledge through the second half of 2022 and imagine Tisotumab has the potential to develop into a best-in-class monotherapy therapy choice for BPDCN sufferers.
With that, I’ll flip the decision over to Susan to cowl the financials. Susan?
Susan Altschuller — Senior Vice President and Chief Monetary Officer
Thanks, Anna. Beginning with our outcomes for the full-year 2021. We generated $69.9 million in income, $46.8 million of which got here from noncash royalty revenues. The rest got here from license and milestone charges, which embrace recognition of $14.6 million of the $40 million upfront price, beforehand obtained beneath the corporate’s collaboration settlement with Huadong Drugs and $7.4 million of income from companion milestones. Working bills have been $194.9 million, comprised of $151.1 million of R&D bills in contrast with $114.6 million in 2020 and $43.8 million of G&A bills in contrast with $38.6 million in 2020.
We ended 2021 with $478.8 million in money on the stability sheet. Turning to our monetary steering for 2022. We anticipate revenues to be between USD75 million and USD85 million, working bills between USD285 million and USD295 million and money and money equivalents at year-end between USD245 million and USD255 million. Given the vary and timing for potential approval of mirvetuximab, income steering doesn’t but embrace potential product gross sales from mirvetuximab. We anticipate that our present money, mixed with the anticipated product and collaboration revenues will fund operations comfortably into 2024.
With that, I’ll flip the decision over to Mark for closing feedback.
Mark Enyedy — President and Chief Government Officer
Thanks, Susan. We entered this 12 months with a motivated and robust workforce and thrilling prospects for the enterprise. Between now and the tip of the 12 months, we anticipate to launch our first product, report pivotal knowledge for PVAC, advance our early-stage packages and additional construct our pipeline and analysis capabilities. We now have the correct technique, management and sources in place to generate vital worth within the close to and long-term and I sit up for extra good days for our individuals, our enterprise and our sufferers.
With that, we’ll open the decision for questions.
Questions and Solutions:
Operator
[Operator Instructions] And our first query coming from the road of John Newman of Canaccord. Your line is now open.
John Newman — Canaccord — Analyst
Hello, guys. Good morning. Thanks for taking my query. Congrats on the continued progress. Simply have two fast questions. First one is for the progression-free survival knowledge from SORAYA at SGO, simply curious if we’ll see each investigator-assessed and independently assessed. After which on pivekimab or 632, simply curious as to what affected person inhabitants and potential mixtures you’re contemplating for a future pivotal examine? Thanks.
Mark Enyedy — President and Chief Government Officer
Anna?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Hello, John. Yeah. So at SGO, we may have the total knowledge set from SORAYA which is able to embrace total response charge, period of response, subsets and we are going to embrace PFS knowledge as properly. I might encourage of us to come back to SGO to evaluate the PFS knowledge and we may have an investor occasion shortly thereafter. Transferring on to the PVAC query, by way of future pivotal trial, we’re fascinated with the triplet pivekimab, plus azacitidine plus venetoclax in relapsed/refractory AML based mostly on the information that we’ve already generated in Part one dose escalation and now we’re exploring in an enlargement cohort that doubtlessly may help a single-arm examine within the relapsed setting. As well as, we plan to discover a frontline setting for this triplet and may these knowledge look promising, then we may think about a frontline randomized Part three trial to help approval for that triplet within the frontline setting.
John Newman — Canaccord — Analyst
Nice, thanks.
Operator
And our subsequent query coming from the road of Michael Schmidt from Guggenheim Securities. Your line is open.
Yige Guo — Guggenheim Securities — Analyst
Hello, good morning. That is Yige Guo for Michael. Congrats on the progress and thanks for taking our questions. Two fast questions from us. Primary, for MIRASOL, Anna, may you please assist us perceive the combination of the sufferers with and with out prior bevacizumab. How are the 2 teams totally different in baseline traits? And the way would possibly that influence the response to mirv? And the second query, are you able to speak about your Camptothecin ADC platform that you simply licensed to Eli Lilly, how is the payload totally different from different kind one Topoisomerases focused ADC? Thanks.
Mark Enyedy — President and Chief Government Officer
Anna?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Yeah, so for MIRASOL, the affected person inhabitants will embrace each sufferers with and with out prior bevacizumab much like FORWARD I, the prior Part three examine, the place we had a combination of sufferers. In FORWARD 1, about half of the sufferers had prior bevacizumab and half didn’t. We anticipate the same affected person combine in MIRASOL. And when you concentrate on which sufferers get bevacizumab, they are usually sufferers with worse prognosis and are extra closely pretreated. Let me begin with the more severe prognosis after which transfer to closely pretreated.
Bevacizumab is authorized in a number of setting for ovarian most cancers. The one considered one of which that has demonstrated an total survival benefit is within the first-line setting for poor danger sufferers. These are sufferers with stage 4 illness, sub-optimally debulked, ascites, and so on. So many physicians typically reserve bevacizumab for these worse sufferers, significantly in Europe. And we are able to see that really within the SORAYA examine while you come to SGO by way of the demographics of the sufferers enrolled by way of their stage of illness. Transferring to variety of prior strains of remedy additionally bevacizumab, it’s exhausting for us in prior research to tease aside bevacizumab versus variety of prior therapies.
And as some extent of reference to help that, within the FORWARD I examine, 65% of sufferers had one to 2 prior strains of remedy and 35% had three priors. You might recall that in SORAYA, 51% of sufferers had three prior strains of remedy. So the SORAYA inhabitants is extra closely pretreated and doubtlessly a worse inhabitants than what we anticipate seeing within the MIRASOL examine based mostly on the prior FORWARD I examine.
Transferring to the subsequent query on Camptothecin, so our Camptothecin payloads are particularly designed to handle antitumor — potent antitumor exercise and have principally distinctive properties from a chemical perspective that give broad IP protection for us. I feel that’s what I can say at this level. I don’t know, Mark, if you wish to add any colour to the Camptothecin payloads?
Mark Enyedy — President and Chief Government Officer
Yeah, perhaps just a bit broader statement right here. So we take some satisfaction in having a number of lessons of payloads to use to ADC. So we’ve acquired at the very least three generations of maytansine. We now have our indolinobenzodiazepine DNA-acting payloads and we have been searching for extra lessons. And our workforce engineered this new model of the Camptothecin with the aim of broadening the therapeutic index versus what we see with among the different Camptothecin which were deployed within the AP context and we’ve acquired excellent preclinical knowledge supporting that we’ve been in a position to drive exercise at the very least in that vary with higher tolerability. So we’re enthusiastic about that, Lilly was enthusiastic about that and are transferring ahead with tech switch for them for his or her targets, whereas on the similar time advancing inner packages that can deploy that payload.
Yige Guo — Guggenheim Securities — Analyst
Thanks very a lot.
Mark Enyedy — President and Chief Government Officer
Positive.
Operator
And our subsequent query coming from the road of Etzer Darout with BMO Capital Markets. Your line is open.
Etzer Darout — BMO Capital Markets — Analyst
Nice. Thanks for taking the query. First one for me, with respect to PFS and SORAYA, I assume how significant is that this replace out of your perspective on this late line submit bev setting? And can we see benchmarks for this particular inhabitants at SGO? After which secondly, on IMGN151, given type of the CMC submission replace, are you continue to on tempo to start out the Part one within the first half of this 12 months? Thanks.
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Yeah, I’ll take the PFS query after which we are able to — I’ll flip it over to you, Mark for the 151 query. So relating to SORAYA, you’re completely proper. The inhabitants is a late line submit bev setting. And albeit, this is without doubt one of the most closely pretreated inhabitants that has been studied in platinum-resistant ovarian most cancers in a examine of this dimension. So there are not any good benchmarks.
However what I can let you know is there are a number of research which were revealed exhibiting in ovarian most cancers as in different stable tumors, the regulation of diminishing returns, if you’ll, with every line of remedy, the expectation for response charge, period of response and progression-free survival diminishes. So while you get to those actually later-line sufferers, physicians expectations relating to efficacy are fairly low given their expertise.
And definitely the information that we’ve shared with the investigators on the SORAYA examine, they’re fairly happy with totality of the efficacy knowledge that we’ve shared with them by way of ORR, period of response and PFS as a result of as I mentioned, the expectations that they’ve for these sufferers later line post-bev setting is kind of low.
What I’ll let you know is that we’ll share knowledge at SGO to place the PFS knowledge from SORAYA into context based mostly on what we’ve recognized from prior research of mirvetuximab. As you’ve seen, we’ve replicated the general response charge knowledge in SORAYA that we had beforehand gathered in that 70 sufferers of foundational knowledge that principally created the speculation that we’ve examined in SORAYA and now confirmed. So once more, we’ll have the information and put it into context for you at SGO. Mark, over to you for 151.
Mark Enyedy — President and Chief Government Officer
Yeah, thanks. So simply to reiterate the purpose that we made within the introductory remark, this can be a CMC not a medical problem. So with a purpose to problem a examine might proceed letter for an IND, the FDA requires the sponsor to submit CMC knowledge referring to the drug, together with drug product stability. Most frequently these knowledge are included within the IND submission. And in some circumstances, the sponsor will make the information out there to the company through the evaluation interval. Within the case of 151, we plan to submit the required knowledge through the evaluation interval.
Nevertheless, because of delays at our drug substance vendor, we weren’t in a position to safe a drug product manufacturing slot as we had deliberate, which meant that we weren’t able to replace the IND through the evaluation interval, so the company put us on maintain. We’ve now secured our drug product slot for this quarter and we are going to generate the required knowledge and anticipate to come back off medical maintain sooner or later. It’s too early to offer up to date steering by way of — we will probably be delayed, but it surely’s too early to offer up to date steering on the time line for first affected person in, however we are going to replace you after we’ve acquired a greater sense following the DP run.
Etzer Darout — BMO Capital Markets — Analyst
Bought it. Thanks and congrats on all of the progress.
Mark Enyedy — President and Chief Government Officer
Thanks.
Operator
And our subsequent query coming from the road of Boris Peaker with Cowen. Your line is open.
Boris Peaker — Cowen — Analyst
Nice, thanks. Perhaps trying ahead to the SGO, I feel lot of buyers are going to be centered, clearly, on the PFS consequence and also you mentioned us invasive to estimate the chance of success of MIRASOL. So perhaps you may assist us attempt to perceive how we ought to be considering of translating the PFS from SORAYA to MIRASOL quantitatively?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Thanks, Boris. I feel we’ve truly significantly better knowledge to information PFS from FORWARD I to MIRASOL. What I imply by that’s that PFS in a single-arm examine like SORAYA is de facto not interpretable. You don’t have a management arm to tease aside the antitumor exercise from the underlying tempo of illness. And in order that’s why FDA doesn’t use PFS when they’re taking a look at antitumor exercise to help accelerated approval, it’s about ORR and DOR. If individuals need to assess the chance of technical success for MIRASOL, I might encourage them to evaluation the information that we’ve already generated in FORWARD I.
Recall that FORWARD I used to be the randomized Part three examine of mirvetuximab versus investigator selection chemotherapy. And within the FRa-high subset recognized by the PS2 scoring technique, that’s the inhabitants that we’re principally replicating in MIRASOL. And in FORWARD I, we demonstrated a median PFS in that inhabitants of 5.6 months. The hazard ratio in FORWARD I based mostly on both investigator or unbiased blinded unbiased evaluation was round 0.6. And chances are you’ll recall that in MIRASOL, we’ve designed the examine to focus on a hazard ratio of 0.7 rather more conservatively.
So we’ve already run the experiment in FORWARD I. The inhabitants in MIRASOL will probably be primarily the identical by way of platinum resistance one to 3 priors, FR-alpha excessive, about half of them having prior bevacizumab. The one distinction is that we’ll have a better share of sufferers with PARP inhibitors now. And we’ve already demonstrated in SORAYA and also you’ll see the total knowledge at SGO that mirvetuximab has very good exercise no matter prior PARP use or not. So from our perspective, the SORAYA knowledge elevated the chance of technical success for MIRASOL as a result of we now have that reply about what about prior PARP inhibitors. Thanks, Boris.
Boris Peaker — Cowen — Analyst
Bought it. And my second query is on the CADENZA examine in BPDCN. May you simply set expectation what you could present within the examine for approval?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Yeah, so the statistical design for Cadenza is de facto permitting us to enroll a cohort of as much as 20 sufferers on this extremely uncommon indication. There’s someplace between 500 and 1,000 new sufferers a 12 months within the US and equally in Europe. And so trying on the efficacy knowledge for the one authorized agent in BPDCN, we all know that the CR/CRC charge is within the 40% to 50% vary. And so we would wish to display a CR/CRC charge in that vary with good efficacy. And from a statistical perspective that based mostly on the pattern dimension that we’re utilizing, that guidelines out this 10% CRC charge that FDA guided us to.
Boris Peaker — Cowen — Analyst
Bought it. Thanks for taking my query.
Mark Enyedy — President and Chief Government Officer
Positive.
Operator
Our subsequent query coming from the road of Andy Hsieh with William Blair. Your line is open.
Andy Hsieh — William Blair — Analyst
Nice. Thanks for taking my questions and congratulations on all of the progress final 12 months. So first query has to do with all the brand new trials. So Anna, I’m simply curious when you’ve got form of selected the trial design for GLORIOSA by way of therapy period within the upkeep area? And in addition perhaps a step again, can you employ this trial as a confirmatory examine for PICCOLO? I do know that generally FDA permits you to affirm utilizing form of a distinct affected person inhabitants? And the second query is for Kristen. I’m simply curious, as you put together to launch MIR, have you ever selected how the drug will probably be distributed? So particularly, I’m curious in regards to the ordering and supply system. Is that totally on demand? And if that’s the case, how ought to we take into consideration the gross to web? Thanks.
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Positive. So we’re actually excited in regards to the GLORIOSA examine, which is a examine of including mirvetuximab to upkeep bevacizumab versus upkeep bevacizumab within the recurrent platinum-sensitive setting. Why are we enthusiastic about this? As a result of we’ve already generated stunning knowledge within the therapy setting for the mirv, bev doublet exhibiting response charges of 59% in platinum-resistant illness, 69% in platinum-sensitive illness which can be above the benchmarks.
And so we need to transfer that energetic, well-tolerated doublet into the upkeep setting. We all know that sufferers as soon as they’ve recurrent platinum-sensitive illness, increasingly of them may have already had a PARP inhibitor within the frontline setting. And so utilizing a triplet within the recurrent platinum-sensitive setting makes an entire lot of sense. So with that, we are going to take all sufferers who’ve accomplished their triplet by way of the carboplatin doublet portion of it.
And so long as they haven’t progressed, so that they have a CR, a PR or a steady illness, they are going to be randomized to mirv bev versus bev alone. And chances are you’ll recall that on this setting, that total therapy path for bevacizumab solely — bev solely provides about three to 4 months of progression-free survival. So including mirvetuximab, a non-cross-resistant focused cytotoxic, we anticipate that we’ll have responses on the mirv-bev arm and there will probably be a protracted therapy period on the mirv-bev arm actually benefiting sufferers. The first endpoint is progression-free survival.
The examine additionally has ample energy for us to display an total survival benefit and that would actually rework the therapy paradigm for these sufferers. Relating to your query about confirming whether or not or not GLORIOSA may stand in as a confirmatory trial for PICCOLO, it’s a bit too quickly for us to work that by way of. PICCOLO is enrolling now and we have to interact with FDA on the precise standards for a path towards accelerated approval. So I might keep tuned for that. And let me flip it over to Kristen now.
Kristen Harrington-Smith — Senior Vice President and Chief Industrial Officer
Thanks, Anna. So to answer your query, we do plan on utilizing a 3PL. So such as you mentioned a on-demand or a drop-ship mannequin. And that is to assist us with our development to web. However presently, that’s all we want to touch upon gross to web. Does that assist?
Andy Hsieh — William Blair — Analyst
Sure. Okay. So I assume the query is de facto how would the form of gross web differ from different medicine or extra conventional distribution. In order that’s form of the place I’m interested in?
Kristen Harrington-Smith — Senior Vice President and Chief Industrial Officer
Yeah, so our aim is to keep away from lots of the wholesaler charges.
Andy Hsieh — William Blair — Analyst
Okay. That’s [Indecipherable]
Mark Enyedy — President and Chief Government Officer
Yeah, no, no, so I imply while you have a look at the affected person numbers and volumes right here, there’s no have to have an enormous quantity of stock sitting at wholesalers ready to be distributed. So it’s rather more environment friendly from our perspective. And many of the ADCs use this mannequin of organising a 3PL after which having the orders are available and filling these utilizing the drop ship mannequin. In doing that and organising a really streamlined strategy right here, we’re avoiding lots of the charges which can be attended to having stock sitting at a wholesaler. We will’t let you know proper now what precisely the gross to web can be and that most likely wouldn’t be a good suggestion within the first occasion.
Andy Hsieh — William Blair — Analyst
Proper. Okay. That’s actually useful. Thanks a lot. So Anna, I’m curious the — so the — is there like a set period for the upkeep Part for GLORIOSA, is it like one 12 months, 18 months or two years. I’m simply curious if that’s been set?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Yeah, so within the frontline setting, while you do upkeep trials, there’s a fastened period as a result of there’s an opportunity that a few of your sufferers are going to be cured. After you have recurrent platinum-sensitive illness, the expectation is that you simply’re not cured. So sufferers will probably be handled till development and insupportable toxicity or insupportable toxicity. However I’ve to say, I imply, throughout the mirv program, we’ve had sufferers on mirvetuximab for one 12 months, two years, three years, even as much as 4 years and nonetheless going.
So by way of the tolerability of mirvetuximab as a monotherapy, we all know that it’s fairly properly tolerated. And with the mirv-bev, we’ve had sufferers on that doublet for a superb very long time as properly, each within the platinum-resistant and the platinum-sensitive setting. So I can’t let you know an estimated period in upkeep within the recurrent platinum-sensitive setting, but it surely’s going to be lengthy as a result of we all know that the PFS of those sufferers goes to be fairly lengthy.
Andy Hsieh — William Blair — Analyst
Nice. Thanks a lot for answering all my questions.
Mark Enyedy — President and Chief Government Officer
Thanks, Andy.
Operator
And our subsequent query coming from the road of Kelly Shi with Jefferies. Your line is open.
Han — Jefferies — Analyst
Good morning. That is Han [Phonetic] calling in for Kelly Shi. First, thanks, first, congratulation on the nice quarter. So my query is de facto for the MIRASOL trial. Given the belief for the median PFS, the chemo arm is about 3.5 months. Do you see any danger that the management arm would possibly outperform on condition that extra non-obligatory chemo remedy is on the market for the management arm? After which my second is relating to to the ECOG 01 efficiency standing. Do you see which will additionally affect the affected person consequence within the management and therapy arm and the way the affected person in time period of the constant weight of the 01 standing — it’s constant from the FORWARD I trial to SORAYA and MIRASOL trials.
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Okay. So your query in regards to the progression-free survival estimate on the management arm of MIRASOL, we’ve designed it for 3.5 months as a result of that’s just about what each examine in platinum-resistant ovarian most cancers has proven. I might remind you that in FORWARD I, for the FR-alpha excessive subset, we truly had a median PFS of three.2 months. There are some research on the market suggesting that FR-alpha is a poor prognostic issue.
So it could be with single-agent chemotherapy, sufferers with excessive FR-alpha do worse than the general inhabitants. So if something, I feel the management arm on MIRASOL would possibly underperform, not outperform. I didn’t perceive your remark about it’d outperform as a result of extra choices can be found. The choices on the MIRASOL management arm are topotecan, paclitaxel and Doxil, similar to they have been within the FORWARD I examine. These are all medicine which were authorized 20 years in the past. So it’s not like now there’s extra higher therapies, sadly we’re utilizing the identical outdated single-agent chemotherapies which were round for a few many years.
So if something, I feel the management arm and MIRASOL would possibly underperform, however we actually didn’t design it, assuming that it wanted to for achievement of the examine. Transferring to ECOG efficiency standing 0 or 1. The ECOG efficiency standing is 0 means individuals really feel completely properly. ECOG standing of 1 means they’re a bit drained and the decrease the efficiency standing, actually the more severe sufferers do.
And that’s why we’ve excluded sufferers with poor efficiency standing two, three or 4 as a result of that’s when you realize that the dangers of the — no matter you’re learning start to doubtlessly outweigh the profit as a result of the sufferers simply aren’t match sufficient. So given the inhabitants that we’ve enrolled throughout the mirvetuximab program, ECOG standing is 0 or 1, we sometimes have the same distribution throughout all of the research and we don’t anticipate any distinction from an efficacy or a tolerability perspective for both subset of sufferers.
Han — Jefferies — Analyst
Nice, thanks a lot. That’s very useful.
Operator
Our subsequent query coming from the road of Kennen MacKay with RBC Capital. Your line is open.
Kennen MacKay — RBC Capital — Analyst
Hey, good morning and thanks for taking the query. Only one on the SORAYA submitting level. Is the information from SORAYA ample for the Ventana 4R1 companion diagnostic and accelerated approval of the diagnostic as properly? Or is there extra knowledge from MIRASOL or different trials sooner or later that’s additionally wanted or once more simply in a confirmatory sense? After which on the MIROVA trial, are you able to perhaps speak in regards to the rationale for that trial and that carboplatin plus mirv doublet and doubtlessly what the subsequent steps there could possibly be? Thanks.
Mark Enyedy — President and Chief Government Officer
Positive. I’ll take the CDX query after which Anna you possibly can speak about IST with tougher. So the reply is sure. The information from SORAYA are ample to help the approval of the companion diagnostic. I feel as we’ve mentioned beforehand on these calls, we’re working with Ventana, which is Roche Tissue Diagnostics, they’ve truly submitted the PMAs in 4 modules. They’ve already submitted the primary module. They’ve our medical, which is being built-in into the next modules enabled file and shut proximity to our BLA submission, which might put them on monitor to have the CDx authorized similtaneously the drug.
Anna Berkenblit — Senior Vice President, Chief Medical Officer
And for the MIROVA examine, this can be a randomized Part two investigator-sponsored trial in Germany led by Dr. Philip Tougher. It’s roughly 140 sufferers who will probably be randomized 1:1 to mirvetuximab plus carboplatin, adopted by mirvetuximab continuation versus carboplatin doublet of selection adopted by upkeep of selection. And the concept right here is, while you speak to physicians about mirvetuximab, they need to have the ability to exchange paclitaxel with our drug as a result of sufferers don’t lose their hair. We now have much less neuropathy.
And so that is the primary alternative for us to actually mix mirv plus CARBO in a bigger examine for Dr. Tougher to take action and evaluate it instantly to straightforward carboplatin doublet, which embrace carbo paclitaxel, carbo doxil and carbo gemcitabine. And so this examine will assist us get a greater sense of the tolerability profile of the doublet as a result of at this level our database is proscribed, but additionally the antitumor exercise efficacy within the recurrent platinum-sensitive setting head-to-head towards out there therapies.
So this knowledge set from MIROVA will assist information additional improvement of mirvetuximab plus carboplatin as a doublet. I ought to level out it’s that it is without doubt one of the three prongs that we’re taking to grasp the potential of mirvetuximab plus carboplatin. The second prong is a neo-adjuvant examine, IST right here within the US, led out of Ohio State. And that examine is within the neo-adjuvant setting, the primary time we are able to get mirvetuximab in untreated sufferers upfront with tumor tissue out there on the time of their debulking examine — surgical procedure.
After which the third is Trial 0420 that you simply heard about earlier, which is mirvetuximab plus carboplatin in a broader inhabitants of FR-alpha optimistic tumors. So between these three — amongst these three knowledge units, we are going to then have ample knowledge to help the registration path for the mirvetuximab plus carboplatin doublet.
Kennen MacKay — RBC Capital — Analyst
Bought it. Thanks. After which perhaps only one follow-up. You’ve talked about that there’s actually some proof and a few publications on the market to help the truth that sufferers with FORWARD receptor-positive illness or boy receptor excessive optimistic illness, doubtlessly have worse outcomes. Is there some other knowledge that the workforce is engaged on or that may develop into out there that could possibly be used to type of additional help that issue or be added to the SORAYA Accelerated Approval submission? Or if not, what dataset do you see as probably the most supportive for that? Thanks.
Anna Berkenblit — Senior Vice President, Chief Medical Officer
So we don’t want any knowledge relating to FR-alpha as a prognostic issue to help our SORAYA examine and our path towards accelerated approval. We all know that FR-alpha is predictive of profit from mirvetuximab. We now have a biomarker recognized inhabitants in SORAYA, FR- alpha excessive sufferers who clearly profit from mirvetuximab with a close to tripling of the response charge, clinically significant period of response and really good tolerability.
And so FR-alpha is clearly predictive of profit from mirvetuximab. The one knowledge set that we are able to level to now that’s extra sturdy by way of answering this prognostic query, the one knowledge set that we are able to level to actually is the FORWARD I knowledge set the place we did the submit hoc evaluation taking a look at mirv versus chemotherapy as a result of, once more, you want this management arm, proper, as a result of that’s the place you’re assessing how sufferers do with out there therapies, the place we inadvertently enroll the low, medium and excessive sufferers.
And you’ll see with the upper the FR-alpha expression, the more severe sufferers do with investigator selection chemotherapy, be it response charge or progression-free survival. And I feel, frankly, that’s the one knowledge set that we’re going to have for some time, Kennen, as a result of now that we all know we’re centered on the FR-alpha excessive sufferers roughly 40% of all the ovarian most cancers sufferers who profit probably the most from mirvetuximab.
I imply, down the highway, perhaps with mirvetuximab plus carboplatin after we display very good exercise throughout a broader spectrum of FR-alpha sufferers and we do a randomized trial there, perhaps then we’ll have a mixture of sufferers the place we are able to circle again on this query of it being a prognostic issue. However actually, from a improvement perspective and from — for physicians to grasp who advantages one of the best from mirvetuximab, it’s FR-alpha excessive sufferers and that’s what issues probably the most.
Kennen MacKay — RBC Capital — Analyst
Bought it. Thanks once more and looking out ahead to seeing you in your subsequent evaluation.
Mark Enyedy — President and Chief Government Officer
Thanks.
Operator
And our subsequent query coming from the road of Jessica Fye with JPMorgan. Your line is open.
Jessica Fye — JPMorgan — Analyst
Hey, guys. Good morning. Thanks for taking my query. Perhaps yet one more particular one on SGO. Ought to we anticipate to see a swim plot, spider plot, a waterfall at SGO? And in addition will we see a PFS Kaplan-Meier curve or simply the median PFS quantity?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Come to SGO, Jess. We may have visualizations of the information so that you can perceive the information.
Jessica Fye — JPMorgan — Analyst
Okay. Nice. And on the platinum-sensitive setting, are you able to speak about what you see because the bars both for approval or for additional improvement for the Part three evaluating mirvetuximab plus bev upkeep and the float receptor excessive platinum delicate setting, in addition to for that mirv combo with mirvetuximab continuation within the form of broader folate receptor expressing inhabitants?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Positive. So by way of the bar, we’ve designed GLORIOSA, the randomized Part three examine to help full approval. The first endpoint is progression-free survival, it’s about 440 sufferers and the hazard ratio we’re aiming for is round 0.7 or that’s what it’s designed for. And so this examine is designed in a sturdy method to display superior efficacy for mirvetuximab plus bevacizumab versus bevacizumab alone. By way of the bar for mirvetuximab plus carboplatin that doublet, we might anticipate needing a randomized Part three examine for that doublet.
So once more, we would wish an adequately powered randomized Part three examine with a management arm of ordinary out there platinum-based doublets that ought to reply your query, Jess, as a result of these are each — the methods can be randomized trials. I feel the place the bar is much less clear to be trustworthy and the unmet want is growing is within the later line platinum-sensitive sufferers that we’re learning within the PICCOLO examine.
That’s a inhabitants the place I feel the unmet want is growing and the bar there may be not clear. We’ve already generated a handful of information supporting that — going ahead with the PICCOLO examine and we glance ahead with partaking FDA on what the bar can be in that setting to help approval from a single-arm trial for an accelerated approval.
Jessica Fye — JPMorgan — Analyst
Bought it. Thanks.
Operator
And our subsequent query coming from the road of Earl De with H.C. Wainwright. Your line is open.
Earl De — H.C. Wainwright — Analyst
Hey, good morning, everybody. Thanks for taking my query. Most of my questions have been answered. I simply puzzled, may you guys give us extra colour on the benefit for the Camptothecin platform? And if potential, may you guys give us extra colour on the partnership with Eli Lilly?
Mark Enyedy — President and Chief Government Officer
Positive, I imply we lined most of what we’ve mentioned publicly about this program. So our chemists have been searching for an extra payload. We famous the that Daiichi was having fun with with their Camptothecin. So the query was, as a medicinal chemistry train, may we design a greater topo1 inhibitor that among the camptothecin class that may broaden the therapeutic index for the payload both by higher tolerability, higher efficacy in each. What we expect we’ve is a molecule with at the very least equal efficacy with higher tolerability and we expect doubtlessly higher bystander killing with this molecule. In order that’s the premise. After which I can’t actually touch upon the financials of the deal past what’s included within the press launch that we issued final week or the week earlier than.
Earl De — H.C. Wainwright — Analyst
Thanks for the extra colour. And congrats on the progress this quarter.
Mark Enyedy — President and Chief Government Officer
Thanks.
Operator
And our subsequent query coming from the road of Joe Catanzaro with Piper Sandler. Your line is open.
Joe Catanzaro — Piper Sandler — Analyst
Hey, guys. Thanks a lot for taking my query right here. Perhaps one simply fast one for me. If I feel again to FORWARD I, I feel it took about 10 months or so from enrollment completion to readout. So simply questioning, why there will probably be a shorter window for MIRASOL. I do know it’s not perhaps apples-to-apples, however perhaps you may assist us higher perceive that dynamic, whether or not or not it’s enrollment kinetics, occasion charge or different issues? And if there’s danger that the readout could possibly be pushed past 3Q. Thanks.
Anna Berkenblit — Senior Vice President, Chief Medical Officer
You’re spot on enrollment kinetics affect the timing of the readout. So progression-free survival is the first endpoint, it’s an event-driven examine, proper? So we are going to set off the evaluation for the first endpoint after we attain the requisite variety of occasions. And that could be a perform of each the enrollment, in addition to the timing of the occasions. The occasion charge in MIRASOL is and ought to be much like the occasion charge in FORWARD I, on condition that we’re enrolling very comparable populations.
The enrollment charge in MIRASOL has been totally different from FORWARD I. With FORWARD I, we had a really, very brisk enrollment the final three months, prefer it simply shot up like loopy. So an entire bunch of sufferers have been enrolled proper on the very finish. So we needed to wait a superb very long time to get to the requisite variety of progression-free survival occasions. Right here with MIRASOL being a bigger examine and with the pandemic, we don’t anticipate that tremendous duper sharp tail in enrollment just like the curve proper up and in order that accounts for the variations within the timing. And so we’re on monitor for high line knowledge in Q3.
Joe Catanzaro — Piper Sandler — Analyst
Okay. Bought it. That’s actually useful. Thanks for taking my query.
Mark Enyedy — President and Chief Government Officer
Positive.
Operator
And our subsequent query coming from the road of Jonathan Chang with SVB Leerink. Your line is open.
Jonathan Chang — SVB Leerink — Analyst
Hello, guys. Thanks for taking my questions, couple of non-mirv questions for me. First query, are you able to present any colour in your income steering of USD75 million to USD85 million, you famous that this doesn’t embrace potential product gross sales from mirvetuximab. So for those who may present any colour as to what’s mirrored on this steering, that may be useful. After which the second query is, are you able to present any extra colour on how the IMGC936 dose escalation goes? And any extra granularity on when preliminary knowledge could possibly be disclosed this 12 months. Thanks.
Mark Enyedy — President and Chief Government Officer
Nice. Susan?
Susan Altschuller — Senior Vice President and Chief Monetary Officer
Yeah, so on the income steering, we embrace our noncash royalty revenues and the license and milestone charges to inclusive of the USD75 million to USD85 million. So we don’t embrace the Merck product revenues as a result of we don’t have a PDUFA date but, in fact. And in order that the timing of potential revenues would make a consider that. In order that’s what’s inclusive within the income steering.
Anna Berkenblit — Senior Vice President, Chief Medical Officer
And turning to IMGC936, we’re in dose escalation for this novel ADC with a novel ADAM9 directed antibody and the primary DM21 linker payload. So we’re in dose escalation and we sit up for presenting knowledge later this 12 months as soon as we’ve recognized the advisable Part two dosing schedule after which we’ll be capable of additionally share plans for additional improvement in ADAM9 optimistic tumors.
Jonathan Chang — SVB Leerink — Analyst
Bought it. Thanks.
Operator
And that’s on a regular basis we’ve for our Q&A session. I might now like to show the decision again over to Mr. Mark Enyedy for any closing remarks.
Mark Enyedy — President and Chief Government Officer
Nice. Thanks, everyone for becoming a member of us at this time. We’re excited in regards to the 12 months forward. We now have plenty of necessary occasions upcoming, beginning with SGO in a few weeks and we sit up for speaking to all of you then. So thanks very a lot and we’ll maintain you up to date on our progress.
Operator
[Operator Closing Remarks]
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