ImmunoGen, Inc. (NASDAQ: IMGN) FY 2021 earnings name dated Feb. 25, 2022
Company Contributors:
Courtney O’Konek — Senior Director of Company Communications and Investor Relations
Mark Enyedy — President and Chief Govt 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, girls and gents and welcome to ImmunoGen’s Fourth Quarter and Full-year 2021 Monetary and Working Outcomes Convention Name. [Operator Instructions]
Right now, 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 present’s name. Earlier at present, we issued a press launch that features a abstract of our latest progress and fourth quarter and full-year 2021 monetary outcomes. This press launch and a recording of this name might be discovered beneath the Buyers and Media part of our web site at immunogen.com. With me at present 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 may also be part of us for Q&A.
Throughout at present’s name, we’ll overview latest accomplishments for the enterprise, our monetary outcomes and spotlight upcoming anticipated occasions. We are going to use forward-looking statements with respect to our enterprise technique, the event and advantage of 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 steerage and our money runway.
Every forward-looking assertion is topic to dangers and uncertainties that might trigger our precise outcomes to vary materially from such statements. These dangers and uncertainties embody these described in our press launch issued this morning and within the Threat Issue part of our most up-to-date annual report on Type 10-Ok 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 converse 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 Govt Officer
Good morning, everybody and thanks for becoming a member of us at present. 2021 was a productive yr for ImmunoGen, with vital progress throughout the enterprise as we transfer in the direction of our goal of changing 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 applications, 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 increase on these factors, beginning with our lead program, Mirvetuximab Soravtansine in ovarian most cancers. Our high precedence this yr is to realize accelerated approval for mirvetuximab as a monotherapy in sufferers with folate receptor alpha optimistic platinum-resistant illness. To this finish, we consider 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 top of this quarter and are getting ready for a possible accelerated approval and launch within the second half of the yr. We additionally count on 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 turn out to be 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 focus on 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 targeted 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 means of tailor-made schooling and steerage 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 marketing and medical schooling groups and have most 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 count on high line knowledge within the frontline cohort within the second half of this yr. 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 growth cohort for the triplet relapsed sufferers and count on to maneuver into frontline sufferers through the yr. Concerning our earlier-stage portfolio, dose escalation continues within the Section 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 sorts and anticipate sharing knowledge from this program later this yr. We additionally submitted the IND for IMGN151, our next-generation antifolate receptor alpha ADC. Attributable to a delay in drug product manufacturing at our vendor, FDA positioned a maintain on our IND software pending responses to some CMC-related info request.
We’re producing the info responsive to those requests and sit up for enrolling our first affected person following submission of this info to the company. Turning to enterprise growth, 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 expertise 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 yr with over $475 million in money. These funds along with product and collaboration revenues will help the enterprise by means of the preliminary launch of mirvetuximab and different materials inflection factors into 2024.
With that, I’ll flip the decision over to Anna to offer some extra shade on our medical applications. 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 finally relapsed with platinum-resistant illness. Remedy possibility 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 a few prior traces of remedy, together with prior bevacizumab. The first endpoint of confirmed goal response price 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 obtainable remedy in platinum-resistant illness. Median length of response or DOR is a key secondary endpoint and was 5.9 months as of the info cutoff on November sixteenth, 2021, with almost half of the responders nonetheless receiving mirvetuximab at the moment, the length of response continues to evolve. These outcomes are significantly encouraging in mild of the closely pretreated inhabitants, wherein 51% of sufferers had three prior traces of remedy.
All sufferers obtained prior bevacizumab and 48% had obtained a previous PARP inhibitor. Turning to security. The profile in SORAYA is according to the identified 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 price 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 complete SORAYA knowledge set at SGO through the plenary late-breaking summary session on Saturday, March nineteenth. Knowledge will embody up to date length of response and key subgroup analyses, together with sufferers with three prior traces of remedy and those that obtained a previous PARP inhibitor.
Development-free survival knowledge may also be offered. As talked about, we’re on monitor to submit the BLA for mirvetuximab earlier than the top of the primary quarter in help of potential accelerated approval later this yr. 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 growth.
PICCOLO was designed to deal with the growing unmet want for an efficient nonplatinum possibility in later traces of platinum-sensitive illness. With an general response price of 64%, our Section one knowledge present potential for mirvetuximab on this affected person inhabitants. We’ve 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 count on to realize 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 Section 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 general 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 advantage of 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 shall be randomized to both mirvetuximab plus bevacizumab or bevacizumab alone for upkeep. The first endpoint is progression-free survival, secondary endpoints embody general survival and general response price. We anticipate initiating GLORIOSA within the second quarter of this yr.
Given the promising exercise we’ve seen with the mirvetuximab plus carboplatin growth in Section I dose escalation in recurrent platinum-sensitive illness throughout a spread of folate receptor alpha expression with an ORR of 80% and median length response of 24 months in FR-alpha medium and excessive sufferers, we lately introduced the deliberate initiation of Trial 0420. Trial 0420 is a single-arm Section 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 info from this examine will inform our path to registration on this setting. Shifting to pivekimab sunirine, our CD123 concentrating on ADC. We offered preliminary security and efficacy findings from the Section 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 price.
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 obtainable therapies. We’ve opened an growth cohort in relapsed AML sufferers and plan to provoke a frontline growth cohort later this yr. Additionally at ASH, we offered 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 better treatment-related antagonistic occasions and no capillary leak syndrome. We proceed to enroll sufferers within the US and Europe in CADENZA, our pivotal Section II examine in frontline and relapsed/refractory BPDCN, anticipate high line knowledge through the second half of 2022 and consider Tisotumab has the potential to turn out to be a best-in-class monotherapy remedy possibility 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 embody recognition of $14.6 million of the $40 million upfront price, beforehand obtained beneath the corporate’s collaboration settlement with Huadong Medication 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 steerage for 2022. We count on 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 steerage doesn’t but embody potential product gross sales from mirvetuximab. We count on 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 Govt Officer
Thanks, Susan. We entered this yr with a motivated and powerful workforce and thrilling prospects for the enterprise. Between now and the top of the yr, we count on to launch our first product, report pivotal knowledge for PVAC, advance our early-stage applications and additional construct our pipeline and analysis capabilities. We’ve 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 combos you’re contemplating for a future pivotal examine? Thanks.
Mark Enyedy — President and Chief Govt Officer
Anna?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Hello, John. Yeah. So at SGO, we may have the complete knowledge set from SORAYA which is able to embody general response price, length of response, subsets and we’ll embody PFS knowledge as properly. I might encourage of us to return to SGO to evaluate the PFS knowledge and we may have an investor occasion shortly thereafter. Shifting on to the PVAC query, when it comes to future pivotal trial, we’re fascinated by the triplet pivekimab, plus azacitidine plus venetoclax in relapsed/refractory AML based mostly on the info that we now have already generated in Section one dose escalation and now we’re exploring in an growth cohort that probably might 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 might take into account a frontline randomized Section 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, might you please assist us perceive the combo of the sufferers with and with out prior bevacizumab. How are the 2 teams totally different in baseline traits? And the way may that impression the response to mirv? And the second query, are you able to speak about your Camptothecin ADC platform that you just licensed to Eli Lilly, how is the payload totally different from different sort one Topoisomerases focused ADC? Thanks.
Mark Enyedy — President and Chief Govt Officer
Anna?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Yeah, so for MIRASOL, the affected person inhabitants will embody each sufferers with and with out prior bevacizumab much like FORWARD I, the prior Section three examine, the place we had a mix 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 permitted in a number of setting for ovarian most cancers. The one certainly one of which that has demonstrated an general 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 will see that really within the SORAYA examine while you come to SGO when it comes to the demographics of the sufferers enrolled when it comes to their stage of illness. Shifting to variety of prior traces 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 traces of remedy and 35% had three priors. It’s possible you’ll recall that in SORAYA, 51% of sufferers had three prior traces of remedy. So the SORAYA inhabitants is extra closely pretreated and probably a worse inhabitants than what we anticipate seeing within the MIRASOL examine based mostly on the prior FORWARD I examine.
Shifting to the following query on Camptothecin, so our Camptothecin payloads are particularly designed to deal with antitumor — potent antitumor exercise and have mainly distinctive properties from a chemical perspective that give broad IP protection for us. I believe that’s what I can say at this level. I don’t know, Mark, if you wish to add any shade to the Camptothecin payloads?
Mark Enyedy — President and Chief Govt Officer
Yeah, possibly just a bit broader commentary right here. So we take some pleasure in having a number of courses of payloads to use to ADC. So we’ve obtained no less than three generations of maytansine. We’ve our indolinobenzodiazepine DNA-acting payloads and we have been on the lookout for extra courses. And our workforce engineered this new model of the Camptothecin with the purpose of broadening the therapeutic index versus what we see with a number of the different Camptothecin which have been deployed within the AP context and we’ve obtained superb preclinical knowledge supporting that we’ve been capable of drive exercise no less than 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 identical time advancing inside applications that can deploy that payload.
Yige Guo — Guggenheim Securities — Analyst
Thanks very a lot.
Mark Enyedy — President and Chief Govt 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 publish bev setting? And can we see benchmarks for this particular inhabitants at SGO? After which secondly, on IMGN151, given form of the CMC submission replace, are you continue to on tempo to begin the Section one within the first half of this yr? Thanks.
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Yeah, I’ll take the PFS query after which we will — 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 publish bev setting. And admittedly, 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 measurement. So there aren’t any good benchmarks.
However what I can inform you is there are a number of research which have been 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 price, length 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 positively the info that we’ve shared with the investigators on the SORAYA examine, they’re fairly happy with totality of the efficacy knowledge that we now have shared with them when it comes to ORR, length of response and PFS as a result of as I stated, the expectations that they’ve for these sufferers later line post-bev setting is sort of low.
What I’ll inform you is that we’ll share knowledge at SGO to place the PFS knowledge from SORAYA into context based mostly on what we’ve identified from prior research of mirvetuximab. As you’ve seen, we’ve replicated the general response price knowledge in SORAYA that we had beforehand gathered in that 70 sufferers of foundational knowledge that mainly created the speculation that we now have examined in SORAYA and now confirmed. So once more, we’ll have the info and put it into context for you at SGO. Mark, over to you for 151.
Mark Enyedy — President and Chief Govt Officer
Yeah, thanks. So simply to reiterate the purpose that we made within the introductory remark, this can be a CMC not a medical difficulty. So in an effort to difficulty a examine might proceed letter for an IND, the FDA requires the sponsor to submit CMC knowledge regarding the drug, together with drug product stability. Most frequently these knowledge are included within the IND submission. And in some instances, the sponsor will make the info obtainable to the company through the overview interval. Within the case of 151, we plan to submit the required knowledge through the overview interval.
Nevertheless, because of delays at our drug substance vendor, we weren’t capable of safe a drug product manufacturing slot as we had deliberate, which meant that we weren’t able to replace the IND through the overview interval, so the company put us on maintain. We’ve now secured our drug product slot for this quarter and we’ll generate the required knowledge and count on to return off medical maintain sooner or later. It’s too early to present up to date steerage when it comes to — we shall be delayed, nevertheless it’s too early to present up to date steerage on the time line for first affected person in, however we’ll replace you once we’ve obtained a greater sense following the DP run.
Etzer Darout — BMO Capital Markets — Analyst
Received it. Thanks and congrats on all of the progress.
Mark Enyedy — President and Chief Govt 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 believe lot of buyers are going to be targeted, clearly, on the PFS consequence and also you stated us invasive to estimate the likelihood of success of MIRASOL. So possibly you possibly can assist us attempt to perceive how we must be considering of translating the PFS from SORAYA to MIRASOL quantitatively?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Thanks, Boris. I believe we now have 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 actually 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 antitumor exercise to help accelerated approval, it’s about ORR and DOR. If individuals need to assess the likelihood of technical success for MIRASOL, I might encourage them to overview the info that we’ve already generated in FORWARD I.
Recall that FORWARD I used to be the randomized Section 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 mainly 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 impartial blinded impartial overview was round 0.6. And you could recall that in MIRASOL, we’ve designed the examine to focus on a hazard ratio of 0.7 way more conservatively.
So we’ve already run the experiment in FORWARD I. The inhabitants in MIRASOL shall be primarily the identical when it comes to platinum resistance one to a few priors, FR-alpha excessive, about half of them having prior bevacizumab. The one distinction is that we’ll have the next proportion of sufferers with PARP inhibitors now. And we’ve already demonstrated in SORAYA and also you’ll see the complete 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 likelihood 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
Received it. And my second query is on the CADENZA examine in BPDCN. May you simply set expectation what it is advisable present within the examine for approval?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Yeah, so the statistical design for Cadenza is actually 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 yr within the US and equally in Europe. And so trying on the efficacy knowledge for the one permitted agent in BPDCN, we all know that the CR/CRC price is within the 40% to 50% vary. And so we would wish to display a CR/CRC price in that vary with good efficacy. And from a statistical perspective that based mostly on the pattern measurement that we’re utilizing, that guidelines out this 10% CRC price that FDA guided us to.
Boris Peaker — Cowen — Analyst
Received it. Thanks for taking my query.
Mark Enyedy — President and Chief Govt 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 yr. So first query has to do with all the brand new trials. So Anna, I’m simply curious in case you have type of selected the trial design for GLORIOSA when it comes to remedy length within the upkeep area? And likewise possibly a step again, can you utilize this trial as a confirmatory examine for PICCOLO? I do know that generally FDA permits you to affirm utilizing type of a unique 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 shall be distributed? So particularly, I’m curious concerning 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 concerning 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 remedy setting for the mirv, bev doublet exhibiting response charges of 59% in platinum-resistant illness, 69% in platinum-sensitive illness which are above the benchmarks.
And so we need to transfer that lively, 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’ll take all sufferers who’ve accomplished their triplet when it comes to the carboplatin doublet portion of it.
And so long as they haven’t progressed, in order that they have a CR, a PR or a steady illness, they are going to be randomized to mirv bev versus bev alone. And you could recall that on this setting, that complete remedy 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 shall be a protracted remedy length 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 general survival benefit and that might actually rework the remedy paradigm for these sufferers. Concerning your query about confirming whether or not or not GLORIOSA might stand in as a confirmatory trial for PICCOLO, it’s a bit too quickly for us to work that by means of. PICCOLO is enrolling now and we have to have interaction 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 stated a on-demand or a drop-ship mannequin. And that is to assist us with our progress 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 actually how would the type of gross web differ from different medication or extra conventional distribution. In order that’s type of the place I’m inquisitive about?
Kristen Harrington-Smith — Senior Vice President and Chief Industrial Officer
Yeah, so our purpose is to keep away from lots of the wholesaler charges.
Andy Hsieh — William Blair — Analyst
Okay. That’s [Indecipherable]
Mark Enyedy — President and Chief Govt 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 a large quantity of stock sitting at wholesalers ready to be distributed. So it’s way 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 in and filling these utilizing the drop ship mannequin. In doing that and organising a really streamlined method right here, we’re avoiding a number of the charges which are attended to having stock sitting at a wholesaler. We are able to’t inform you 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 hard and fast length for the upkeep Section for GLORIOSA, is it like one yr, 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 length as a result of there’s an opportunity that a few of your sufferers are going to be cured. After getting recurrent platinum-sensitive illness, the expectation is that you just’re not cured. So sufferers shall 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 yr, two years, three years, even as much as 4 years and nonetheless going.
So when it comes to 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 great very long time as properly, each within the platinum-resistant and the platinum-sensitive setting. So I can’t inform you an estimated length in upkeep within the recurrent platinum-sensitive setting, nevertheless it’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 Govt 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 actually 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 may outperform on condition that extra elective chemo remedy is offered 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 end result within the management and remedy 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 concerning the progression-free survival estimate on the management arm of MIRASOL, we now have 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 might be with single-agent chemotherapy, sufferers with excessive FR-alpha do worse than the general inhabitants. So if something, I believe the management arm on MIRASOL may 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, identical to they have been within the FORWARD I examine. These are all medication which have been permitted 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 have been round for a few a long time.
So if something, I believe the management arm and MIRASOL may underperform, however we definitely didn’t design it, assuming that it wanted to for fulfillment of the examine. Shifting 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, definitely 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 that the dangers of the — no matter you’re finding out start to probably 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 usually 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 info 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 possibly discuss concerning the rationale for that trial and that carboplatin plus mirv doublet and probably what the following steps there could possibly be? Thanks.
Mark Enyedy — President and Chief Govt Officer
Positive. I’ll take the CDX query after which Anna you may speak about IST with tougher. So the reply is sure. The info from SORAYA are ample to help the approval of the companion diagnostic. I believe 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 permitted similtaneously the drug.
Anna Berkenblit — Senior Vice President, Chief Medical Officer
And for the MIROVA examine, this can be a randomized Section two investigator-sponsored trial in Germany led by Dr. Philip More durable. It’s roughly 140 sufferers who shall be randomized 1:1 to mirvetuximab plus carboplatin, adopted by mirvetuximab continuation versus carboplatin doublet of selection adopted by upkeep of selection. And the thought right here is, while you discuss to physicians about mirvetuximab, they need to have the ability to substitute paclitaxel with our drug as a result of sufferers don’t lose their hair. We’ve much less neuropathy.
And so that is the primary alternative for us to actually mix mirv plus CARBO in a bigger examine for Dr. More durable to take action and evaluate it straight to plain carboplatin doublet, which embody 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 restricted, but in addition the antitumor exercise efficacy within the recurrent platinum-sensitive setting head-to-head in opposition to obtainable therapies.
So this knowledge set from MIROVA will assist information additional growth 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 will get mirvetuximab in untreated sufferers upfront with tumor tissue obtainable on the time of their debulking examine — surgical procedure.
After which the third is Trial 0420 that you just 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’ll then have ample knowledge to help the registration path for the mirvetuximab plus carboplatin doublet.
Kennen MacKay — RBC Capital — Analyst
Received it. Thanks. After which possibly only one follow-up. You’ve talked about that there’s definitely 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, probably have worse outcomes. Is there another knowledge that the workforce is engaged on or which may turn out to be obtainable that could possibly be used to form 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’ve a biomarker recognized inhabitants in SORAYA, FR- alpha excessive sufferers who clearly profit from mirvetuximab with a close to tripling of the response price, clinically significant length of response and really good tolerability.
And so FR-alpha is clearly predictive of profit from mirvetuximab. The one knowledge set that we will level to now that’s extra strong when it comes to answering this prognostic query, the one knowledge set that we will level to actually is the FORWARD I knowledge set the place we did the publish hoc evaluation 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 obtainable 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 price or progression-free survival. And I believe, 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 targeted on the FR-alpha excessive sufferers roughly 40% of the entire ovarian most cancers sufferers who profit probably the most from mirvetuximab.
I imply, down the highway, possibly with mirvetuximab plus carboplatin once we display very good exercise throughout a broader spectrum of FR-alpha sufferers and we do a randomized trial there, possibly then we’ll have a mixture of sufferers the place we will circle again on this query of it being a prognostic issue. However actually, from a growth perspective and from — for physicians to grasp who advantages the perfect from mirvetuximab, it’s FR-alpha excessive sufferers and that’s what issues probably the most.
Kennen MacKay — RBC Capital — Analyst
Received it. Thanks once more and looking out ahead to seeing you in your subsequent overview.
Mark Enyedy — President and Chief Govt 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 another particular one on SGO. Ought to we count on to see a swim plot, spider plot, a waterfall at SGO? And likewise 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 info so that you can perceive the info.
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 growth for the Section 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 type of broader folate receptor expressing inhabitants?
Anna Berkenblit — Senior Vice President, Chief Medical Officer
Positive. So when it comes to the bar, we now have designed GLORIOSA, the randomized Section 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 strong method to display superior efficacy for mirvetuximab plus bevacizumab versus bevacizumab alone. When it comes to the bar for mirvetuximab plus carboplatin that doublet, we might anticipate needing a randomized Section three examine for that doublet.
So once more, we would wish an adequately powered randomized Section three examine with a management arm of ordinary obtainable platinum-based doublets that ought to reply your query, Jess, as a result of these are each — the methods can be randomized trials. I believe the place the bar is much less clear to be sincere and the unmet want is growing is within the later line platinum-sensitive sufferers that we’re finding out within the PICCOLO examine.
That’s a inhabitants the place I believe the unmet want is growing and the bar there’s not clear. We’ve already generated a handful of knowledge 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
Received 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, might you guys give us extra shade on the benefit for the Camptothecin platform? And if doable, might you guys give us extra shade on the partnership with Eli Lilly?
Mark Enyedy — President and Chief Govt Officer
Positive, I imply we coated most of what we now have stated publicly about this program. So our chemists have been on the lookout 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, might we design a greater topo1 inhibitor that a number of the camptothecin class that might increase the therapeutic index for the payload both by higher tolerability, higher efficacy in each. What we expect we now have is a molecule with no less than equal efficacy with higher tolerability and we expect probably 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 shade. And congrats on the progress this quarter.
Mark Enyedy — President and Chief Govt 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 believe again to FORWARD I, I believe it took about 10 months or so from enrollment completion to readout. So simply questioning, why there shall be a shorter window for MIRASOL. I do know it’s not possibly apples-to-apples, however possibly you possibly can assist us higher perceive that dynamic, whether or not or not it’s enrollment kinetics, occasion price 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’ll set off the evaluation for the first endpoint once we attain the requisite variety of occasions. And that could be a operate of each the enrollment, in addition to the timing of the occasions. The occasion price in MIRASOL is and must be much like the occasion price in FORWARD I, on condition that we’re enrolling very comparable populations.
The enrollment price 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 great 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. Received it. That’s actually useful. Thanks for taking my query.
Mark Enyedy — President and Chief Govt 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 shade in your income steerage of USD75 million to USD85 million, you famous that this doesn’t embody potential product gross sales from mirvetuximab. So should you might present any shade as to what’s mirrored on this steerage, that might be useful. After which the second query is, are you able to present any extra shade on how the IMGC936 dose escalation goes? And any extra granularity on when preliminary knowledge could possibly be disclosed this yr. Thanks.
Mark Enyedy — President and Chief Govt Officer
Nice. Susan?
Susan Altschuller — Senior Vice President and Chief Monetary Officer
Yeah, so on the income steerage, we embody our noncash royalty revenues and the license and milestone charges to inclusive of the USD75 million to USD85 million. So we don’t embody the Merck product revenues as a result of we don’t have a PDUFA date but, after all. And in order that the timing of potential revenues would make a think about that. In order that’s what’s inclusive within the income steerage.
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 yr as soon as we’ve recognized the advisable Section two dosing schedule after which we’ll have the ability to additionally share plans for additional growth in ADAM9 optimistic tumors.
Jonathan Chang — SVB Leerink — Analyst
Received it. Thanks.
Operator
And that’s on a regular basis we now have 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 Govt Officer
Nice. Thanks, everyone for becoming a member of us at present. We’re excited concerning the yr forward. We’ve plenty of essential 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]
