ImmunoGen Inc (IMGN) 2015 Q3 法說會逐字稿

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  • Operator

  • Good day and welcome everyone to this ImmunoGen third-quarter fiscal year 2015 financial results conference call. Today's call is being recorded.

  • At this time for opening remarks and introductions I would like to turn the call over to Executive Director, Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.

  • Carol Hausner - Executive Director, IR and Corporate Communications

  • Thank you. Good morning. At 6:30 this morning we should a press release that summarizes our financial results for the quarter ended March 31, 2015, the third quarter of our 2015 fiscal year. I hope you have all had a chance to review it. If not, it is available on our website.

  • During today's call we will make forward-looking statements. Our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings which also can be accessed through our website.

  • In our call today our Chief Executive Officer, Dan Junius, will provide an update on ImmunoGen; our Chief Development Officer, Dr. Charlie Morris, will discuss our lead wholly-owned compounds in greater depth; and our Chief Financial Officer, Dave Johnston, will discuss our financial results in guidance. We will open the call to questions after these updates. Our Chief Scientific Officer, Dr. Rich Gregory, will also be available for the Q&A part of the call. Dan?

  • Dan Junius - President and CEO

  • Thank you, Carol, and good morning, everybody. We stated in our last call that we expect 2015 to be a notable year for ImmunoGen and I think if anything, that momentum has accelerated since then. We are seeing encouraging findings with mirvetuximab soravtansine, and that is the official nonproprietary name for what we have been referring to as IMGN853. But we are seeing these encouraging findings in the treatment of platinum resistant ovarian cancer and are preparing to advance this compound in this indication and also further expand its development program.

  • You will hear more from Charlie about these plans shortly but I should note that they were one of the key drivers behind the royalty transaction we closed earlier this month. We don't want funding to slow the development of what we view to be a very promising compound.

  • Findings to date in platinum resistant ovarian cancer will be presented at ASCO next month so at that point you will be able to see what we are seeing. You will also hear from Charlie about our promising compounds for hematologic malignancies. That would include IMGN529 for B-cell malignancies including diffused large b-cell lymphoma and IMGN779 for acute myeloid leukemia and myelodysplastic syndrome.

  • Additionally as you probably saw in the release, we have now regained rights to the CD19 targeting ADC coltuximab ravtansine also referred to as SAR3419. This had been in development with Sanofi.

  • You might recall that the findings from its Phase 2 STARLIGHT trial were chosen for oral presentation at ASCO last year and also were selected for the best of ASCO. For this compound, the investigators noted that coltuximab ravtansine had demonstrated significant activity, this was as a single agent, in the treatment of relapsed refractory diffused large B cell lymphoma and also that it has an acceptable safety profile.

  • In terms of another compound, we also have opt in rights with BioTest to jointly develop and commercialize indatuximab ravtansine or BT062 in the US. This CD138 targeting ADC is in Phase 2 testing for the treatment of multiple myeloma and also in Phase 1 testing for triple negative breast cancer and metastatic urinary bladder cancer. So there are a lot of promising compounds advancing in our pipeline, most of which we wholly own and BT-062 where we have opt in rights.

  • Beyond our own product programs, we continue to invest in our technology as well as in our research program. For example, earlier this week there were a number of presentations by ImmunoGen scientists at AACR including ones in our DNA acting payload agents on site-specific conjugation approaches and on the companion diagnostic for mirvetuximab soravtansine. Also our partners, Sanofi and Novartis, had presentations on novel ADC compounds they have developed using our technology. We expect additional partner compounds to enter the clinic this year and others already in the clinic to have data presentations and potentially meaningful development events in the coming year.

  • The most visible of these developments today is the Kadcyla data from the MARIANNE study to be presented at ASCO on June 1, but I suspect that is already on everyone's radar screen.

  • With that let me turn it over to Charlie to discuss our wholly-owned product programs in more detail.

  • Charlie Morris - EVP and Chief Development Officer

  • Thanks, Dan, and good morning, everyone. Yes, we have a lot going on on our plates right now and we expect this to increase going forward.

  • I will start with mirvetuximab soravtansine, formally known as IMGN853. This is the first and only ADC directed at the folate receptor alpha FRA to begin to enter clinical testing combining the tumor exposure benefits and antibody targeting agent and our ADC technology. Folate receptor alpha is highly expressed on many cases of ovarian cancer and also in other types of solid tumors including some endometrial cancers and lung cancers.

  • As you know, we started by assessing mirvetuximab soravtansine administered every three weeks in patients with tumors likely to express folate receptor alpha. Once we established its recommended Phase 2 dose, we began testing mirvetuximab soravtansine specifically for the treatment of platinum resistant ovarian cancer and relapsed refractory endometrial cancer in patients prescreened for [oblasta target] presence again using the every three week dosing schedule.

  • As Dan noted, we are encouraged by the findings to date with this product in ovarian cancer and are preparing to expand its assessment for this use. As discussed previously, our first step is increasing the size of the current study cohort from 20 to 40 patients to give us additional efficacy and safety experience. We are now also planning to start Phase 2 clinical testing with mirvetuximab soravtansine used as a single agent in patients with platinum resistant ovarian cancer.

  • The study is being designed to support the possibility of accelerated registration approach in this cancer. In planning this study and thinking about the registration pathway, we are simultaneously addressing all the supporting issues such as those related to CNC in clinical materials and having a companion diagnostic.

  • And we are planning this year to initiate assessment of mirvetuximab soravtansine used as part of combination regimens as they should further expand the opportunity to help patients with folate receptor alpha positive ovarian cancer including patients with less heavily pretreated disease. We have received input from opinion leaders in this area and they are helping us think about the full spectrum of need and how we might best address these needs with mirvetuximab soravtansine.

  • We have applied for and received orphan drug designation for ovarian cancer in the United States some time ago but didn't yet have the findings needed to secure it in Europe. I am pleased to report that we recently gained orphan drug designation for ovarian cancer in the EU as well.

  • In addition to ovarian cancer, other types of solid tumors can highly express folate receptor alpha. We have a cohort open assessing it for target positive endometrial cancer and are also evaluating it -- assessing it in target positive non-small cell lung cancer. We will determine the next steps for these cancer types when we have the data to do so.

  • As you can likely tell, we are pleased with the findings we are seeing with the administration of mirvetuximab soravtansine once every three weeks. However to ensure we have optimized dosing, we are also evaluating a weekly schedule to determine if this could provide additional benefits. Dose exploration is ongoing and the findings we have to date will be reported at ASCO next month. So there is a lot going on with mirvetuximab soravtansine.

  • Turning now to our IMGN529 agent for B-cell malignancies, this CD37 targeting ADC is currently in the dose-finding portion of a Phase 1 trial assessing it as a single agent in patients with non-Hodgkin's lymphoma. The findings with 529 to date are encouraging particularly in the treatment of relapsed refractory diffused large B-cell lymphoma and we plan to initiate assessment of the compound specifically in the treatment of this cancer once we have the recommended Phase 2 dose.

  • We also plan to start evaluating it for the treatment of chronic lymphocytic leukemia and other highly CD37 positive malignancies. Additionally, we have seen interesting findings pre-clinically with the use of IMGN529 in combination with rituximab and are preparing to start a trial later this year to assess this combination in the clinic.

  • These preclinical findings were accepted for presentation at the International Congress of Malignant Lymphoma meeting in Lugano which will be in June. So a lot is going on with this promising compound as well.

  • As Dan noted, we regained rights to the CD19 targeting ADC, coltuximab ravtansine, previously known as SAR3419 from Sanofi. Clinical findings for this product candidate were selected for oral presentation at ASCO 2014 and for Best of ASCO as Dan noted. The compound demonstrated a 43.9% objective response rate as a single agent in the treatment of heavily treated DL BCL versus the study hurdle of 20%. The main toxicities were hematological as you would expect in this patient population and any ocular events were grade one or two reflecting the dose optimization work that Sanofi did during the Phase 1 investigation.

  • We think it is of particular interest that the responses to coltuximab ravtansine were seen in patients irrespective of their [cell] of origin classification i.e., responses in both patients with GCB and ABC subtypes of DL BCL.

  • As you know, a number of the newer agents under investigation for this disease have demonstrated very little activity against pretreated GCB disease so we believe that coltuximab ravtansine's activity in relapsed refractory DL BCL classifications may allow us to target a broader population than some other agents.

  • So we now have two agents with potential in B-cell malignancies and we are developing plans to maximize our opportunity in that space.

  • I will wrap up my comments by noting that we are on track for submitting the IND for our CD33 targeting ADC, IMGN779 later this year. It is a new potential treatment for acute myeloid leukemia and myelodysplastic syndrome and uses our new DNA acting payload platform. Preclinical findings with it have been accepted for presentation at the annual European Hematology Association meeting in June.

  • So many trials underway, more to start and a lot of data presentations coming up.

  • With that, I will turn the call over to Dave to discuss the financials.

  • Dave Johnston - EVP and CFO

  • Thanks, Charlie. As Carol noted, we issued a press release this morning with our financial results for the quarter ended March 31, 2015 which is the third quarter of our fiscal year 2015. I will discuss the highlights of that and then review the updated guidance.

  • Our revenues in the quarter were $11.4 million as compared to $6.9 million for the same quarter last year. The current period includes a $5.1 million of revenue from license and milestone fees which is principally a $5 million cash milestone payment earned from Novartis. Our third-quarter financials also include $5.1 million in royalty revenue earned on sales on Kadcyla compared to $2.6 million in the same period last year. As you know, we recently reported a Kadcyla royalty monetization transaction which will be reflected in our financial reports starting next quarter.

  • Operating expenses for the third quarter and fiscal year 2015 were $32.7 million compared to $44.3 million in the same quarter last year. R&D expense was higher in the prior year because it included a $12.8 million non-cash charge related to the collaboration agreement we had executed with CytomX. In this year's third quarter, we had a net loss of $21.6 million or $0.25 per share compared to a net loss of $37.5 million or $0.44 per share in the same quarter of last year.

  • We ended the quarter with $111.8 million of cash and marketable securities compared with $142.3 million as of June 30, 2014. Our cash used in operations was $27.4 million in the first nine months of fiscal 2015 and our capital expenditures were $4.5 million. Subsequent to the close of this quarter, we completed the Kadcyla royalty monetization transaction that provided us with net proceeds of approximately $194 million. Based on this transaction and on our greater visibility into the expected timing of some partner milestone events and research related expenses, we are updating our guidance for the fiscal year ending June 30.

  • We now expect revenue to be between $85 million and $95 million versus prior guidance of between $100 million and $105 million. We now project our operating expenses to be between $145 million and $150 million compared to previous guidance of $160 million to $165 million. Our guidance for our net loss remains unchanged however and is expected to be between $60 million and $65 million. Our guidance for cash used in operations and for capital expenditures is also unchanged with cash used in operations projected to be between $55 million and $60 million and capital expenditures to total between $7 million and $9 million.

  • We now expect to end the year with between $265 million and $275 million in cash and securities compared to previous guidance of $75 million to $85 million. So we have substantially expanded our liquidity, leaving us well positioned to support our product programs.

  • So with that, let me turn the call back over to Dan.

  • Dan Junius - President and CEO

  • Thanks, Dave. Over the course of the year, we look forward to providing you updates in a number of areas. Findings in patients with platinum resistant ovarian cancer treated with mirvetuximab soravtansine will be presented at ASCO on May 30. We are on track to expand its initial assessment in this cancer from 20 to 40 patients and are preparing to start a Phase 2 trial in the indication later this year that could potentially support an accelerated registration pathway. We are also preparing to initiate a trial assessing it as part of a combination regimen for ovarian cancer this year.

  • Patient enrollment is ongoing in the expansion cohort assessing mirvetuximab soravtansine for target positive relapsed refractory endometrial cancer and we are evaluating its potential in other target positive indications as well. We are also continuing assessment of a modified weekly schedule and will be reporting the findings to date at ASCO also on May 30.

  • Dose finding is ongoing in our Phase 1 trial of IMGN529 in non-Hodgkin's lymphoma. Once we have the recommended Phase 2 dose, we will begin its assessment in relapsed refractory DL BCL and begin dose exploration in CLL. We expect this to happen around midyear.

  • We are targeting ASH presentation of the next data with IMGN529 used as a single agent. Preclinical findings with it used in combination with Rituxan will be reported in Lugano as you heard from Charlie and we preparing to start a clinical trial with this combination in the second half of this year.

  • For coltuximab ravtansine, we are assessing next steps and expect to share them with you later this year. For IMGN779, we are on track to advance it to IND submission in the second half of this year and expect to begin patient dosing then early next year.

  • And then a few highlights for key partner programs. The finding with the MARIANNE trial with Kadcyla are scheduled for presentation at ASCO on June 1. Roche indicated they expect the readout from the Kadcyla GATSBY trial in gastric cancer this year and if positive to submit for approval for the use of the study. We expect global sales of Kadcyla continue to grow, we have seen that in the data reported by Roche just earlier this week that Kadcyla continues to expand with acceptance and an increased use ex US.

  • We expect data disclosures and/or developments for other product candidates in the clinic through our partnerships and additional partner compounds to advance in the clinic this year and also to note there continues to be considerable interest in our technology, I think the Takeda license that we announced earlier this month is an indication or I guess it was now in March but speaks to the continued interest in ADCs in general and particular in our technology.

  • All in all it continues to be a very active year and we look forward to reporting our progress as we go forward.

  • So with that, let me turn it back to Carol for the Q&A.

  • Carol Hausner - Executive Director, IR and Corporate Communications

  • Thanks, Dan. We are about to open the call to questions. We would like to ask everyone to limit your questions to one to two per person until everyone has had a chance to ask their questions.

  • Operator, we are now ready to open the line.

  • Operator

  • (Operator Instructions). Chris Marai, Oppenheimer.

  • Chris Marai - Analyst

  • Good morning, guys. Thanks for taking my question. First question really is regarding 853, you certainly indicated that you have seen some interesting signals here in your recent study. If I recall correctly prior studies that you had presented maybe a year or two ago now have not looked all that -- all that interesting on the efficacy side. And I'm wondering if you could help us highlight the difference between the patient populations perhaps or the two studies and why we might be seeing a stronger signal? Is that related potentially to folate expression?

  • Finally, I was curious if you could maybe help us understand 779, it is a CD33 targeted ADC if I am correct and I think one of your competitors out there in ADC land has something similar. So I'm wondering if you can kind of maybe contrast the two approaches? Thanks.

  • Charlie Morris - EVP and Chief Development Officer

  • Thanks, Chris. I will start with the 853 question. I mean first of all, I think we are about five weeks away from ASCO so I think a lot of the obvious questions we will be able to discuss in much more detail once the data become clear. But I think the two key points, the first is obviously the data that we released earlier was in dose escalation. We had not identified a recommended Phase 2 dose and we were doing that in a relatively broad population of patients with unlimited number of prior lines of therapy and with quite broad acceptance of the folate level.

  • I think as we have gone into the dose expansion, we have had a much more limited number of prior lines of therapy. We have been screening for folate expression and we have a dose and so I think the combination of those factors has put us in a position where we are seeing what we think are interesting levels of activity and we will disclose some more information on that next month.

  • So I will hand over to Rich to sort of maybe talk a little bit about 779.

  • Rich Gregory - EVP Research and Chief Scientific Officer

  • So as you know, the 779 program is our first program they are taking to the clinic with our new DNA alkylating class. It is a real advance for us in targeting cancers that will have DNA sensitive targeting. Yes, Seattle Genetics does have a competitive program in the space taking forward also a DNA cross-linking drug and this is the primary difference between our drug and theirs which is ours has in our hands, a better safety profile than you see with a DNA cross-linking drug. So we think we're going to have a better therapeutic index as we take our program forward.

  • Chris Marai - Analyst

  • And that program currently was in AML?

  • Rich Gregory - EVP Research and Chief Scientific Officer

  • Yes.

  • Chris Marai - Analyst

  • Perfect. Okay, thanks. Appreciate the color.

  • Operator

  • Jason Kantor, Credit Suisse.

  • Jason Kantor - Analyst

  • Great, thanks so much. You discussed a possible accelerated path for 853. I think you have spoken about this previously as well and I am wondering if you have had any additional communication with the FDA? I know for other agents in ovarian they have been pretty reluctant to do anything except overall survival. And I am wondering are you planning to seek a breakthrough therapy designation for the drug which I think might help in an accelerated path?

  • Finally, on the EGFR program, I'm not sure if you mentioned it in your comments but I thought in the press release it said that that had gone back into research. I'm wondering if you can give us some details there.

  • Charlie Morris - EVP and Chief Development Officer

  • Thank you, Jason. We have not had that conversation with the FDA at the moment. I think what is notable of course is that there has recently been an accelerated approval for AstraZeneca's olaparib in this space so I think we have at least some sense in a well defined, well described population what the level of activity might that be required to consider accelerated approval. Obviously we will take the opportunity when we have the appropriate amount of data to discuss the opportunity that we see with the agency but we have not had that conversation at this point.

  • In terms of breakthrough status, we are not taking anything off the table. We think that we need to get to the end of the current study to have that type of conversation. Whether that is achievable, that is really going to be down to that conversation at that time but we would agree obviously if we believe that it meets the criteria, we would seek it.

  • 289, that has been in Phase 1 testing as you know in heavily pretreated patients. We have seen an unexpected safety concern and therefore we decided that we should take that out of the current study and do some additional evaluations preclinically to try to understand that and see if that is something that we can work around.

  • Jason Kantor - Analyst

  • And can you tell us what that safety concern is?

  • Charlie Morris - EVP and Chief Development Officer

  • I think at this stage we are not going to be disclosing. That needs to come out in the appropriate sort of clinical settings in due course and as we do the further evaluations, we will be able to provide a comprehensive description and hopefully explanation of the events that we have seen.

  • Jason Kantor - Analyst

  • Thank you.

  • Operator

  • Mara Goldstein, Cantor Fitzgerald.

  • Mara Goldstein - Analyst

  • Thank you very much. I'm hoping you can give us just a little bit more color on coltuximab ravtansine and around the return of rights and how that fits into your budgeting planning for the upcoming year given accelerated development of some of these other agents?

  • Dan Junius - President and CEO

  • Mara, it is Dan. We are looking at that and given the fact that we have now another agent for B-cell malignancies we want to take a look at that along with 529 and we will evaluate what the advantages of each is, where they fit either together or independently and move forward. At the moment I don't think we anticipate a significant impact from a budget standpoint going forward. We have some decisions to make certainly. Were we to be advancing both and I think we would need to see some pretty compelling data to say we advance both, I think that right now our leaning is that we are going to evaluate each of them, see what the advantages are and either through some head-to-head comparison or based on other criteria decide which is the one to take forward. But I don't expect it to be terribly disruptive from a financial standpoint.

  • Mara Goldstein - Analyst

  • Okay, if you choose only to advance one compound, is the other compound a candidate for out licensing? Would that be the plan?

  • Dan Junius - President and CEO

  • Potentially. We would want to work that one through as well. There's a few different things to consider when we go through that and one is do we want to be creating our own competitors but that is just one of a number of factors that we would look at as we evaluate assets and what the appropriate place is for them.

  • Mara Goldstein - Analyst

  • Okay, thank you.

  • Operator

  • Jessica Fye, JPMorgan.

  • Jessica Fye - Analyst

  • Great. Thanks. I guess first, can you just clarify whether the Phase 2 study that you are starting later this year for 853 could potentially be used as a registrational study? Or I guess what is it you mean when you say could support an accelerated registration pathway?

  • Second, just where are you in development with your companion diagnostic and do you need a diagnostic strategy finalized before you move into any kind of pivotal study?

  • Charlie Morris - EVP and Chief Development Officer

  • Thanks, Jessica. What we are planning is that the Phase 2 study would be of a sufficient size to create a sufficiently large database and to be able to have confidence in the size of what we see in terms of the benefits of treatment that that would be something that we would hope could be reviewed. The FDA, you can never be guaranteed of an accelerated approval. It is going to be dependent on data but we are certainly ensuring and embarking upon the next level of investigation that we have everything lined up so that if we continue to see the level of activity we see now, we would be in a position to go to the agency with those data and discuss that possibility for approval. To that end, we have got the CMC pieces worked out and indeed we have signed a deal around a companion diagnostic and we are doing the work on that in parallel.

  • So we're just making sure that everything is there to enable that to happen should the data support it at the end of that study.

  • Dan Junius - President and CEO

  • Jessica, it is Dan. Just to add a little bit to Charlie's comments, at the same time we are not doing this in a vacuum, we are in conversation with experts in the field around ovarian to get their input around data coming out of the study. And so we are testing our assumptions of what we are seeing with the data to ensure that they are well grounded but the approach to make sure that a study could potentially qualify as a pivotal study as Charlie noted is comprehensive. We are trying to look at all of the dimensions that the regulators will look at and make sure we have the foundation in place that would support both a discussion and a potential filing if the data warrants it.

  • Jessica Fye - Analyst

  • Okay, thanks. Maybe just one follow-up, it sort of sounds like you are focusing us on ovarian cancer for 853, should we read this as deemphasizing the endometrial opportunity or where do we stand there?

  • Charlie Morris - EVP and Chief Development Officer

  • I think it is more about emphasizing the ovarian opportunity. It is a more common disease at least in the advanced settings and certainly in our hands we are seeing considerably higher numbers of patients with expression of the target in ovarian cancer than we are in endometrial. So in large part this is about the fact that we have more data in ovarian and we like what we see.

  • So I wouldn't take it as de-emphasis, I would see it more as an emphasis on ovarian and I think the pathways forward there are becoming clearer as we get more data and as we interact with opinion leaders who are giving us the input we need.

  • Jessica Fye - Analyst

  • Great, thank you.

  • Operator

  • Michael Schmidt, Leerink.

  • Michael Schmidt - Analyst

  • Good morning and thanks for taking my question. I just had a follow-up on SAR3419, the CD19 ADC. I guess what was behind the Sanofi decision to return their rights to this compound? It seems a bit surprising in light of the ASCO data presented last year. I noticed that Sanofi recently announced collaborations with other ADC technology companies and I was wondering if there is anything, any concerns behind the technology that caused Sanofi to move forward with this step?

  • Dan Junius - President and CEO

  • I can't speak comprehensively for Sanofi. The indication to us in giving it back was that it was a portfolio decision and as you know, they have done some realignment within their oncology research area.

  • Embedded in your question what you suggest around technology, there is comprehensive data at this point around 3419 and it is indicating both solid activity as well as a good safety profile. So I think people can judge for themselves off of that whether that suggests anything from a technology standpoint, certainly the data that they've presented thus far does not.

  • But we deal with a wide range of partners and you end up with some decisions that reflect their internal strategic direction that aren't always crystal clear to us but each company has some motivation so I wouldn't try to overanalyze it.

  • Michael Schmidt - Analyst

  • Okay. Can you update us on the status of the CD38 antibody that is partnered with Sanofi as well?

  • Dan Junius - President and CEO

  • I am afraid that is going to fall into the same category. That is in Sanofi's portfolio and we really don't want to put ourselves in a position of disclosing information that should be disclosed by a partner. So they have spoken very highly on what they featured at ASCO last year but in terms of their current plans I think I would point you to Sanofi for that.

  • Michael Schmidt - Analyst

  • Great. Thanks so much.

  • Operator

  • Josh Newman, Canaccord.

  • John Newman - Analyst

  • Thanks for taking the question. So had sort of a two-part question. The first one is it sounds like based on your comments that you are encouraged specifically by the magnitude of activity that you are seeing with 853 in ovarian cancer but you are also planning to take the compound forward in terms of combination studies in Phase 2. Should we interpret that as sort of allowing for the current FDA regulatory environment in terms of perhaps combining with Avastin or are there other specific combinations that you have in mind there? It sounds like you are quite positive on what you are seeing in terms of a single agent so I am just curious if there are specific things that you are thinking about doing in Phase 2 just to kind of satisfy the agency? Thanks.

  • Charlie Morris - EVP and Chief Development Officer

  • Yes, we are highly encouraged by what we are seeing as a single agent and just to note again that I think all of our conversations will be helped when that data becomes (inaudible) ASCO in a few weeks time.

  • From a combination point of view, the cancer has never been majorly successfully tackled by single agents and we think that the future opportunity will be probably in combination, not just in single agent. I think there are pathways for approval as a single agent and we hope to go after those. But there are as you note, newly approved agents in the area and things where we believe that the combination could add even more and we have been doing some preclinical work at a [minimum] to understand that. We haven't disclosed yet what those nominations will be but they will be based upon preclinical information that we have and those agents which are widely used in the marketplace today.

  • The Phase 2 that we are designing is a single agent study and that with the hope of really completely characterizing the Phase 2 activity and seeing whether that Phase 2 activity could be enough to support approval -- that would probably be in a later line setting.

  • I think to get into the earlier lines of setting to compete with the multiagent chemotherapy combinations that exist today, we probably need to be in combination to have our greatest chance of success there hopefully with improved safety profile and hopefully with a better efficacy profile to enable that to be successful.

  • John Newman - Analyst

  • Okay, great. Thank you very much

  • Operator

  • Andrew Peters, UBS.

  • Andrew Peters - Analyst

  • Thanks for taking my question. Apologies if this has been asked already. I had some phone troubles throughout the call. Just curious on 779, was wondering if you are using anything that you can learn from the Seattle CD33 program to maybe help in terms of trial design whether that is patient selection or kind of identifying other potential compounds to combine it with to increase activity? So I think CD33 is an interesting target, just curious your strategy going forward there and what you can learn from others? Thanks.

  • Charlie Morris - EVP and Chief Development Officer

  • Yes, I mean obviously we watch what other people are doing and we try to understand, we try to understand their efficacy profile, we try to understand their safety profile and they are a little ahead of us so we have clearly got to understand how we can be competitive. I think watching what they are doing will provide us some important learnings but we have also got to believe in the preclinical data from our own product and the data that we have put together much of which is now being presented to make some of those decisions based on what we believe will be the right thing for our product.

  • But Seattle has already presented some interesting data and we hope we will have similarly if not more interesting data as we get into the clinic in the coming months.

  • Andrew Peters - Analyst

  • Great. Thank you.

  • Operator

  • Jason Kantor, Credit Suisse.

  • Jason Kantor - Analyst

  • Thanks for taking the follow-up. Just wanted to ask kind of a bigger picture question. You are talking about moving into a potentially registrational study which I think will be fantastic. Are you prepared to take this drug all the way and become a commercial entity in cancer? Is this something you want to sell in the US, sell globally? What is your strategic thinking?

  • Dan Junius - President and CEO

  • Jason, it is Dan. We have had discussions about this as far as I can remember when people ask us the question about what the long-term strategy is. And now I think it is coming into sharper focus around 853. The game plan would be -- to answer your question directly -- yes, we would intend to take this forward ourselves and commercialize it.

  • The caveat would be looking at the range of lines of therapy within ovarian, looking at indications where folate Alpha is expressed, there is the potential for broad application for this particular compound. And so I think to be realistic in our expectations or in our ambitions, we would be focusing those on a limited geography. Certainly the US whether that is North America is I will say a detail but we would be looking for a global partner who we would work with then to deal both with the scope and complexities of global development. And I think those can be both complementary and successful in allowing the company to bring this compound forward on an accelerated basis while also transitioning us from what I would now characterize as a development stage company to a fully commercial company.

  • So that is the ambition. We put the financing in place now to take us through the next phase. I think that a global deal as I have described would provide additional financial support to be able to advance this on a prompt or an expeditious basis and also open other opportunities for us to bring additional funding in to support for the development of 853 as well as our further proprietary pipeline.

  • Jason Kantor - Analyst

  • Thank you.

  • Operator

  • John Newman, Canaccord.

  • John Newman - Analyst

  • Thanks for taking a follow-up question. My question is can you tell us when you are talking about the excitement that you have around the level of activity that you are seeing, can you tell us as to how this compares to the statements that you made on the previous call where you said you would want to see something sort of in the 20% to 30% response range to push this forward. Should we be thinking about magnitude of response with respect to current agents or magnitude of response with respect to your prior statements or combination of both? Thanks.

  • Charlie Morris - EVP and Chief Development Officer

  • Sorry to come back to the obvious response but I think this is going to be a much easier conversation in about five week's time, five weeks from tomorrow in fact. So clearly what we have said previously and what we are seeing and saying today are fully consistent with each other. We are in an area of at least by response rate where I think people will be interested in the product when they see it where we have investigators and opinion leaders who are interested in what we are planning to do and are encouraging us to take this forward to the next level. In just a few weeks time, I hope that we can get more into the detail of that and really add a lot more color and make the conversation a little bit easier.

  • John Newman - Analyst

  • Okay. We will anxiously await that data. Thank you very much.

  • Dan Junius - President and CEO

  • Actually abstracts come out in three weeks as opposed to the five weeks and hopefully that will provide some additional color.

  • Carol Hausner - Executive Director, IR and Corporate Communications

  • We will be updating for ASCO obviously.

  • Dan Junius - President and CEO

  • Sure.

  • Carol Hausner - Executive Director, IR and Corporate Communications

  • I think on that note, we are done with questions. I think we are out of questions and so I want to just thank everyone for your interest in ImmunoGen and if you have any subsequent questions, please don't hesitate to give us a call. Take care.

  • Operator

  • Thank you for your participation. That does conclude today's conference.