Feb 17, 2009
Executives
Daniel M. Junius – Chief Executive Officer and President John M.
Lambert, Ph.D. – Chief Scientific Officer and Executive VP of R&D Gregory Perry – Chief Financial Officer and Senior VP James O’Leary – Chief Medical Officer Carol Hausner – Executive Director, Investor Relations and Corporate Communications
Analysts
Shiv Kapoor – Morgan Joseph & Company Jason Kantor – RBC Capital Markets Pamela Bassett – Cantor Fitzgerald Joel Sendek – Lazard Capital Markets
Operator
Good day everyone and welcome to this ImmunoGen second quarter fiscal year 2009 conference call. Today’s call is being recorded, and at this time for opening remarks and introductions, I would like to turn the call over to the executive director of investor relations and corporate communications, Jerrold Housner.
Please go ahead.
Carol Hausner
Good afternoon. At 4 o’clock this afternoon, we issued a press release that summarizes our financial results for our second quarter ending December 31, 2008.
I hope you have all had a chance to read it. If not, it is available on our website at immunogen.com.
During today’s call, we will make forward-looking statements. Our actual results may differ materially from the projections made.
Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filing, which can also be accessed through our website. With me today are Daniel Junius, our Chief Executive Officer; Gregory Perry, our Chief Financial Officer; Dr.
John Lambert, our Chief Scientific Officer; and Dr. James O’Leary, our Chief Medical Officer.
Dan will provide an update on ImmunoGen, and Greg will discuss our financial results. We will then open the call to questions.
Daniel M. Junius
Thank you for joining us for the call today. Let me start by making a few comments about the organization, and certainly, some things have changed over the last several months.
This is my first conference call as CEO of ImmunoGen. As you know, that change took place on January 1, 2009.
Mitch Sayer, our prior CEO, continues with the company and now continues as chairman of our board. Two other additions to the management team have taken place in the last couple of months.
The first is Dr. Jim O’Leary, who came on as our chief medical officer.
Jim joined us in November. He is a board-certified hematologist and oncologist.
Jim’s last position was with Bayer where he led the global clinical development team for a late stage anticancer agent, and before Bayer, he was with Pfizer. There, he lead clinical development teams for two earlier stage anticancer agents and then lead the global clinical development team of a more advanced compound.
Prior to those two companies, Jim was medical reviewer at FDA in the Division of Oncology Drug Products. The other addition is Gregory Perry.
Gregory replaced me in the CFO position earlier this month. Gregory had been with a number of biotechs.
Prior to joining ImmunoGen, he was with Elixir Pharmaceuticals, a pre-IPO company. Prior to that, he was with Domantis, an antibiotic-related therapeutics company, also pre-IPO, and prior to that, he was CFO of TKT.
A lot of Gregory’s earlier career was spent at GE in their medical systems group, and I think that the additions of both Jim and Greg were great additions for the company. We welcome them to the management team here.
Let me talk about some recent corporate achievements, and I want to go through our partner progress as well as our own, but I would also like to incorporate some comments about how we are refining our approach to drug development. Let me start by talking IMGN-901.
What we have done here and are continuing to evolve is putting in place a gated development plan. Now, this follows on Jim joining us, and he having the opportunity along with his clinical team to do an extensive evaluation of the data that we have collected on this particular compound.
As you know, we have multiple possible registration paths for this particular compound. There is multiple myeloma, small-cell lung cancer, ovarian cancer; we have talked about Merkel cell carcinoma where we saw a CR in one of our trials, and there are other potential applications, other CD56-positive lymphomas and leukemias, there are pediatric uses, so there is a wide range of potential applications here, but the assessment of the data has led us to this particular plan that says first, we want to continue to evaluate this compound as monotherapy in multiple myeloma.
What we are doing with that is developing predefined criteria as to what constitutes success, and we will go through that in some detail when we have our analyst event next month down in New York. If these criteria are met, the next step would be to do a phase-II evaluation with a pivotal trial or trials that support accelerated approval, once again with clear targets for activity.
I should say based on data and input from clinical practitioners and experts, we believe there to be potential for this monotherapy approach to be a strong path to the market, and you will hear more about that from Jim as we talk next month. Beyond monotherapy, we have also talked about initiating a combination trial in multiple myeloma, and that is defined as actually a 3-combination approach of IMGN-901 plus Revlimid plus low-dose dexamethasone.
We have done preclinical work that supports this combination. Ideally, we want to first establish the maximum-tolerated dose as monotherapy from the current study.
The combination trial would have a short, roughly 3-step, dose escalation phase to assess the safety of the combination, and then we would dose additional patients at the maximum tolerated dose, probably a limited number of patients, for example, maybe 15 or so. Again before starting this trial, we will have pre-established criteria as to what constitutes success.
Determining these criteria, we will first a competitive environment. We will look at current therapies as well as what is in the pipeline and what has the potential to progress through the pipeline to acceptance.
We will determine the required improvements in efficacy, safety, or both that we would need to achieve to accomplish approval ourselves. So we want to be as clear as we can be in setting these criteria, so we know going into a trial where we have to be at the end as opposed to trying to sort this out after we generate the data.
We will continue to look at solid tumors, but initiation of any new trials to evaluate specific types of solid tumors is gated on achievement of success in multiple myeloma. Now, we do have a solid tumor trial underway as you know.
We may use the expansion phase to gain more information on specific types of solid tumors such as small-cell lung cancer or ovarian cancer, but any significant effort in solid tumors is going to depend on what we see in multiple myeloma. You know we closed study 001 which was a solid tumor study with IMGN-901 focusing on small-cell lung cancer.
Our assessment was that the dose was too low to be effective, and we had learned what we were going to from this study, so therefore, we are in the process of finally closing this down. But with these changes, I want to emphasize that this reflects our ship to be more disciplined in our approach to drug development rather than a change in our view of IMGN-901’s potential.
Reflecting on that, the data we have on IMGN-901 continues to be very encouraging. We reported updated findings at ASH last month from the multiple myeloma monotherapy study.
Within that data, amongst fifteen patients who received at least two cycles of treatment with IMGN-901, eleven had sustained benefit, either an objective response or stable disease. The duration of benefit was impressive to practicing clinicians.
In one case, it extended for over a year. Now, to put this in context, you should appreciate that these patients had received a high number of prior regimens with improved therapy, Velcade, Revlimid, Thalomid, and yet, many are still having benefit from IMGN-901.
As Jim O’Leary did his analysis of the data that we had accumulated. He looked at it and determined that many patients receiving IMGN-901 had stayed on the compound longer than they had remained on regimens used earlier in the course of their disease, i.e., second or third line therapy, and we are coming in, in some cases well beyond second or third line, and we are still getting activity, so we find that to be very encouraging.
We will assemble this information and report on it later this year. I note that while the focus has been on multiple myeloma, because that is the path we are pursuing, we have also seen similarly encouraging findings in solid tumors, some of which we have discussed with you earlier.
Let me now go and talk about IMGN-242. That also has a gated approach that we have talked you about earlier.
That was put in place as we started the phase II for gastric cancer. We were evaluating 23 patients, and if we have a durable objective response, we would expand the study to 40 patients, otherwise we would discontinue development.
Obviously, the decision to proceed will include a higher standard than one objective response. Following his deep immersion into IMGN-901, Jim is now developing the advancement criteria for IMGN-242.
The goal is to have the data needed to make the expansion decision by mid 2009. Obviously, based on the design, if we see an objective response earlier, that decision may come before mid 2009, but we will announce that once we see that response, if it is forthcoming.
We did lose time in enrolling this particular trial, having put through a protocol amendment for an eye toxicity issue that we have discussed with you previously, but I am happy to report that enrollment is now back up to speed. We are actively dosing patients and hopefully will be able to make good progress on this particular trial.
We have submitted an extract to ASCO, so we would hope, therefore, to be able to have data to talk about when we get to the ASCO conference in late May. Beyond what we are doing in clinical stage compounds, we also have established criteria for advancing our earlier stage compounds.
These criteria take advantage of the growing body of clinical and preclinical data, both ours and our partners’, to refine the factors we consider and the weights of these factors in our portfolio advancement decisions. We believe this will have a significant impact on the profile and market potential of the compounds coming out of research pipeline.
Let me now go and talk specifically about what we are seeing with our partners. Let me start with T-DM1.
Genentech reported interim findings on T-DM1 in their second line plus phase 11 trial at the San Antonio Breast Cancer Symposium in December. Here as many of you know, they showed an objective response of approximately 40%.
Interestingly, the response rate in patients who receive Tykerb plus Xeloda was comparable to the overall study population, and we found this highly encouraging. It was supportive of the potential for a third line trial, which actually has started in August 2008, now that would be after Herceptin plus chemo and then Tykerb plus Xeloda.
This phase II trial may prove to be a registration trial depending on the data that it generates. Genentech also announced that they would be initiating a phase III trial with T-DM1 in first half of the year 2009, this current year first half.
Recently, information was on the website, clinicaltrials.gov talking about a single-agent T-DM1 trial versus Tykerb plus Xeloda. The start date is listed as March 2009, shows as a 580-patient trial with HER-2 positive metastatic breast cancer patients who had previously been treated with Herceptin plus a taxane.
There have 260 sites worldwide in the trial, and it is sponsored by both Roche and Genentech. We have previously announced that the start of patient dosing triggers a milestone payment to ImmunoGen; this has been in our forecast from the outset, so that fee in itself does not change our guidance for fiscal 2009.
The second compound I would like to mention is SAR3419. Here, we expect the first clinical data at ASH in December.
Recall this is a CD19-targeting TAP compound that Sanofi-Aventis has in the clinic for non-Hodgkin’s lymphoma. We recently started a study in France with SAR3419.
This will be the second phase I. The first phase I started in October 2007 in the US.
Three other compounds, IMGN-388, EIIB-015, and B2062, all were in the clinic last summer, bringing the total number of TAP compounds in the clinic up to 7. These three are sponsored by ImmunoGen, Biogen Idec, and Biotest respectively.
We would expect first clinical data with at least one, if not all of these compounds, sometime later this year. The last clinical compound is AVE1642.
This is the sole naked antibody that is in clinic, and it targets the IGF1 receptor. Sanofi-Aventis has this trial in the clinic with three combination trials currently underway: a phase I trial in solid tumors with four treatment arms; a phase I-II trial underway in liver carcinoma with multiple treatment arms, this trial started in the fourth quarter of last year; and a phase-II randomized trial in hormone-dependent breast cancer, this also started last quarter and recall that triggered a $4 milestone to ImmunoGen.
We expect additional findings on AVE1642 to be reported sometime in 2009. Beyond the compounds in the clinic, let me also talk about licensing, because we have had activity over the past quarter.
Genentech, as you recall we announced earlier, took a fifth license that was announced December. We have indicated in the past they continue to hold options for other targets.
There are a small number of options, but those are compounds that they will be looking at and in the next several quarters, have to make a decision about whether they are going to exercise and take a license on those targets as well. Beyond that though, we continue to see increased interest in our technology from both current and potential partners.
This is important because it supports the business model. The business model whereby we develop our own compounds but leverage the technology through partnerships reduces our dependence on the capital markets.
The benefits of this have been seen since we have only done one financing since 2000, and that was done in June of last year when we placed shares with a single investor and raised $25 million as the markets were becoming particularly difficult. It is reinforced by the fact we took in $13 million in upfront milestone payments in the first half of this year, and Greg will talk to you about the benefits of that and our performance to date and our outlook for the year.
Gregory Perry
Let us now take you through the highlights of our financials which are discussed in greater detail in today’s release. Our revenues in the second quarter of this fiscal year were $9.3 million compared to $9.8 million for the same quarter last year.
In the second quarter of our 2009 fiscal year, we earned more revenue from license and milestone fees and less revenue from research and development support in clinical materials reimbursement than we did in the second quarter of our 2008 fiscal year. The increase in the license and milestone fees was because we received richer milestone payments in the current quarter compared with previous periods.
The reduction in research and development supports stems largely from the winding down of our collaboration with Sanofi-Aventis, while the reduction in clinical material reimbursement was principally because some of our more advanced partners having established alternative sources for component materials and/or manufacturing as they considered commercial scale quantities. Our operating expenses were $16.4 million in the second quarter of this fiscal year compared to $16.7 million in the same quarter last year, so our loss from operations was similar to our loss in the same period last year.
Our net loss was $7.1 million in the current period compared to $6.2 million in the same period last year. Interest then comes down over $500,000 compared with last year, reflecting current market conditions.
We also recognized a charge of about $270,000 due to impairment in the second quarter of this fiscal year. As Dan noted, we received $13 million in upfront milestone payments from our partners in the first half of this fiscal year.
This doesn’t all immediately reflect in our revenue as much of it would have to be recognized over time. These upfronts and milestones demonstrate the strength of our business model.
During the first half of this fiscal year, our cash used in operations was just $400,000. We had $45.9 million in cash and marketable securities as of December 31, 2008, compared with $47.9 million as of June 30, 2008.
We had no debt in either period. We are off to a strong start for fiscal year 2009, although we had anticipated most of the upfront and milestone payments we have received.
We believe our financials will windup even better than previously projected. We now expect our net loss will be $34 to $37 million as compared to our previous guidance of $37 to $40 million.
We expect our cash use in operations to be between $16 and $19 million, which is also an improvement over our previous guidance of $20 to $23 million. This change is due to our expectation of funding a smaller net loss than previously projected and also to changes in the timing of certain compensation-related expenditures.
We continue to expect our capital expenditures to be between $1 to $3 million, so we expect in this fiscal year between $26 to $29 million in cash and marketable securities.
Daniel M. Junius
Let me talk then about what we expect to see in the calendar year 2009, and now that I am no longer CFO, I get to talk about calendar years and not fiscal years. I will start with T-DM1.
We noted initiation of a phase-III pivotal trial in the first half of 2009. Obviously, that is an important event in and of itself, but also the financial implications and the milestones that it triggers that will be payable to us.
We also will have maturing findings from the phase-11 second-line trial, hopefully at ASCO, but certainly over the course year. The interim data has been presented at a couple of conferences thus far.
We would expect to see that to continue as we move through the current calendar year, and since there are multiple studies underway, some of them going underway in the last summer, there are opportunities for data presentation from those studies as the year progresses. For IMGN-901, we would look to establish MTD in multiple myeloma monotherapy study, and then we will look to gain additional data at MTD and apply that against our predetermined criteria for advancement.
As I noted earlier, we will discuss those criteria in our February 27th event. We would also look to initiate the multiple myeloma trial in combination with Revlimid and low-dose dexamethasone, also with predefined criteria for advancement.
This, we would hope to initiate by the middle of this year. We would like to see data at ASH certainly from the monotherapy study.
It is possible that initial data from a combination study would be there, but that is subject to when we achieve the MTD in the monotherapy study. The success in multiple myeloma is gating to further development in solid tumors, so we will hold off on talking about what we might see there until we make more progress with multiple myeloma.
We would hope to get the MTD in the solid tumor study and report those findings at URTC. For IMGN-242, we would like to expand or discontinue decision in the phase II gastric cancer study.
The goal is by mid year, and again, given that we are back enrolling, we would hope that that would be a reasonable target, and the next step then would be expand to the full 40 patients or to terminate further development. For AVE1642 and SAR3419, both of those programs are expanding.
That creates multiple opportunities for data presentation. And then, the three new compounds, IMGN-388, BT-062, and BIIB015, there are opportunities for data presentation, although likely in the later half of the year.
We are not currently expecting any new compounds, either ours or our partners to enter the clinic in 2009, but we do expect to see good activity in 2010 and beyond. With respect to licensing or partner-related activity, we had a couple of nice announcements in the quarter just ended with Bayer Healthcare and Genentech, based on the increased interest that very well could translate into announcements concerning new or current partners, but the timing on that can be somewhat difficult to predict, but fortunately, it is an active environment, so we are pleased with that.
So that concludes my formal comments. I will turn it over to Carol, and we can start the Q&A.
Carol Hausner
I am about to open the call to questions. Before we do, I would like to ask our analysts to limit themselves to one to two questions so that everybody can have a chance to ask their questions, and we will certainly allow people to come back on to ask additional questions at the end if there is time.
Operator, we are ready now to open the call to questions.
Operator
(Operator Instructions). We will take our first question from Shiv Kapoor with Morgan Joseph.
Shiv Kapoor – Morgan Joseph & Company
Congratulations on the strong operating cash flow this quarter. I am going to ask some partner-related questions, and then I will get back in the queue.
You say in your press release that you expect some partner-related announcements in 2009, would these be clinical data announcements or possibly new partnerships or both?
Daniel M. Junius
I think it would be both, Shiv. In the comments, I tried to separate out what is going on with the specific compounds and what that would lead to in terms of data announcements; but the reference to announcements from new or current partners, obviously from new partners, we could not get much in terms of clinical data, but with current partners, we could potential see more activity there from a licensing standpoint.
I reference the fact that we do not know what direction they are going take, but Genentech has a handful of options that they have to make a decision on, so that could lead to some activity. Sanofi-Aventis last August entered into an arrangement where they could take licenses from us, so there are a lot of structures already in place that people can move on quickly, but there are also our discussions with others which could evolve into licenses, so it is an active environment; it is just difficult to predict with certainty, when, how big, how many, etc., but we are confident that we would see something come through in this calendar year.
Shiv Kapoor – Morgan Joseph & Company
For the new partnerships not involving Genentech and Sanofi, are you going for more product-based or technology-based partnerships and do you think you have better negotiation power now with T-DM1 progressing as well as it is.
Daniel M. Junius
I think the buyer transaction demonstrates that we do have better negotiating power. As the pipeline evolves, I would like to think that would only become stronger.
You asked would they be product or technology, I think at this point the focus is on technology. I think it would be premature; we do not see the need to be looking for product announcements, and by that I think you are referring specifically to 242 and 901.
Shiv Kapoor – Morgan Joseph & Company
What I meant was would these be specific, target-based or…?
Daniel M. Junius
Multitargets?
Shiv Kapoor – Morgan Joseph & Company
Right.
Daniel M. Junius
It could run a spectrum. I would not limit us only to a single target.
There are a variety of types of structures that could come forward.
Operator
We will go on next to Joel Sendek with Lazard Capital Markets.
Joel Sendek - Lazard Capital Markets
Thanks. I have a product question and a finance question.
So first, a specific one on 242, can you give us some sense as to how many of the 23 patients you have any data on so far?
Daniel M. Junius
We cannot at this point. I guess, directional Joel, I would say we are in early innings, not in the first inning, and the guidance is that we think we would get to the 23 by mid year.
May be you can dimension it off that, appreciate the fact that we went for a considerable amount of time with not being able to enroll patients because of trying to sort out the eye toxicity issue, and once we had determined the approach there, and I can go through it, but I think we have taken you through that, so I won’t bore your with it again. Once we restarted those studies, it is like a whole new study, and getting it geared up and getting some momentum into those takes some time, but I think we are over that initial phase.
We have got the PI’s reengaged in the process, and so we are seeing some pretty good activity, which allows me to say maybe by mid year. I hope we have an announcement on it before we get to mid year, because that means we are not announcing we did not get any activity, and we are taking it off the board.
I think the guidance we are trying to get to is that is about how much time we think we would need to enroll 23 patients.
Joel Sendek – Lazard Capital Markets
Okay, good. I just wanted to make sure you were not over 20 right now and just hoping for the last couple.
The next thing is on the financing, so I think it is great that you are spending a little bit less, but still, if I project out until the end of the fiscal year 2009, and assuming you have the same operating cash use next fiscal year as you do this year, you know, you are running about 1 year’s cash; I am wondering if you should be a little bit even more conservative, I mean other companies are icing programs at least temporarily, I am wondering what your thinking is on that?
Gregory Perry
Joel, this is Greg. I think we are very sensitive to that fact, and I think one of the references Dan made earlier was to the strength of the business model, and I do think the business model provides us a bit of flexibility regarding financing the company and provides us perhaps just a bit of measure of flexibility around timing as we think about the ability to raise nondiluted financings from potential partnerships, whether that be a multi-target type of deal or whether that be single product deal.
So, we certainly are aggressively managing expenses, and as you can tell from the tone, aggressively managing these clinical trials, and I think again, we do have some flexibility given the potential for partnerships. Dan.
Daniel M. Junius
I reinforce that. We are very cognizant of the state of capital markets, of what is going on with many other companies in the industry.
Our board is very cognizant of it, and I think the fact that we do feel that we have multiple levers, and look, we are trying to be conservative on expenses without sacrificing our potential. I think that fact there is interest in the technology says that it gives us a higher level of confidence of being able to get something done or somethings done that will extend the runway, potentially in a meaningful fashion without having to go out and raise money.
If it was a matter of we had to go out and bang on every door that we could to find somebody who was going to do a deal at a low price, I would be looking at it much differently. That is not where we are, so it does have us hopefully not overconfident, but comfortable that we can execute the business plan, and if we find we are not able to raise capital from some of those alternative sources, make the appropriate adjustments to pull the spending down.
One of the things that comes into our thinking is when we enter into a deal with a third party, we are not simply handing over a compound and a chemical entity that they can go and then outsource and develop on their own. It takes a significant amount of handholding and support, in many cases support that we get paid for, to be able to do that.
So, to be able to adequately support new licenses, new licensees I should say, new partners, you want to have the infrastructure available to do the work that is going to move those things along at an appropriate pace. So, if the view was that those deals cannot be consummated in a reasonable period of time, we may have to look at our expense structure differently, but I think that if we were to take a very aggressive posture toward expenses right now, it could jeopardize the ability to advance partner deals if we are able to realize them at a reasonable period of time.
Operator
We will take our next question from Pamela Bassett with Cantor Fitzgerald.
Pamela Bassett - Cantor Fitzgerald
Can you characterize the magnitude of the milestone payment you are expecting from Genentech? Should we be thinking of several times prior milestones because it is phase III or are these milestones going to be fairly consistent until you reach registration?
Daniel M. Junius
Let me say a couple of things on it, Pamela. First is to reinforce the point that the milestone, whatever its order of magnitude is, is already built into our projections, so from this standpoint if anybody is surprised with the number, it is not going to change our outlook because it is already there.
The only guidance I would give you is that it is larger than the phase II milestone that we received, which was $5 million, but it is not a double-digit milestone.
Pamela Bassett - Cantor Fitzgerald
So if they move forward with registration of the third line, indication for T-DM1, could that happen this calendar year, and if so, would that render a significant milestone payment?
Daniel M. Junius
We have not provided guidance on what events trigger milestones, and we just cannot do that given the confidentiality issues within the agreements we have, not just with Genentech, but with all of our partners, but to the first half of your question - could they get to registration in this calendar year, I think that would be extremely aggressive and highly unlikely. You just go through sort of the timing of events.
The phase II that has the potential to be the trial on which they would base an accelerated approval is about the same size as the phase II for which enrollment was completed in June 2008. That trial started in July 2007, so it took about 12 months to enroll those patients, roughly the same size trial and all other things being equal, assume 12 months, so you go from August 2008 until July 2009 roughly.
Then, you got to let that data reach a level maturity. If that is the enrollment time period, they are not going have the data sufficiently mature to prepare their enrollment package for the FDA, so I really think that sort of best case is sometime into 2010, whether it is early 2010 or mid 2010, who knows, but I think that is a more likely scenario.
People should not be thinking calendar year 2009 as a possibility, I think that is just extremely aggressive.
Operator
We will take our next question from Jason Kantor with RBC Capital Markets.
Jason Kantor - RBC Capital Markets
Thanks for taking my questions and good to hear you on the call Dan. A couple of things, I guess you already addressed the guidance issues, what other milestones might be included besides the Genentech milestone in your guidance or is that the only milestone that you are including?
Daniel M. Junius
Let me give you a broader answer and come back to the specifics, Jason, because I want to emphasize because of the business model and to help us in our planning, we have to be thinking about what milestones might occur in any particular period and build them into our planning. Fortunately though, because of the relationship with our partners, we generally have pretty good insight in terms how their plans are developing, assuming milestones are development driven, and certainly the history of ImmunoGen is that as development events take place, they trigger a milestone.
We have a good idea when someone is putting and I&D package together, etc. We have dialogue with all of our partners, and so while I know that those are kind of at risk forecasts in a business model, I just to emphasize that they are not as at-risk here as they might be in other situations.
In the time that I have been here, it is not because I great insight, this information comes from others in the organization. I do not think we have had a single milestone that we put into a financial plan that we have missed.
Now, we have had some that we did not expect that we got, so we have to give people some comfort about that process. For your specific question, what is in the back half of the fiscal year, we talked about the T-DM1 phase III.
There really isn’t anything in the back half of the year beyond that. Now, that is not to say other things could happen.
We have visibility to some things that could take place, but we have chosen to not put those in our forecast.
Jason Kantor - RBC Capital Markets
For the relapsed refractory multiple myeloma, is it that you haven’t figured out what you think the right rate would be for running a pivotal study as a single agent or you are just keeping it in some suspense until your analyst day?
Daniel M. Junius
I think it is two things. One is the thinking is still evolving around there.
We have made a lot of progress, but we are not all the way there, and part of my answer was going to be that we want to see the data, but that is not really true. Jim has only been in this role for 3 months.
He has done a terrific job of working his way through the data and pulling out some insights that, quite frankly, we didn’t have visibility to in the past, and as a byproduct of that, we want to thoughtful to say given that and looking at it as a single agent, and some of the discussions he has had with experts in the field as well as clinicians when he was out at ASH and discussions with others around trial design in this area, we just want to make sure that we get it as right as we can. We want to be clear in putting these criteria together; I will have to be very candid and say because there are multiple criteria, you can be very clear on each one, but the combination of them may cloud the issue.
You may be in a very good situation in one area and a different place in another, and then, you will have to apply some judgment to it, but we do want to be clear what we are looking for so that if we do not cross the threshold on any of them, we are done. We are not trying to be cute with it Jason; I just think we want to give it a little bit more though before we take it on broad way.
Jason Kantor - RBC Capital Markets
Will you be disclosing any new targeted TAPs internally at your analyst event. I mean I think people are generally, you know, nobody is pounding the table about these internal compounds, but the technology looks really good, so can you apply it to other targets and other antibodies that are proprietary?
Daniel M. Junius
I would expect we will be talking about it broadly. I do not think we are going to get down to a target specific discussion for a number of reasons, and some of it is the development work requires that we do certain things around IP and whatnot until we are all the way there; it is not appropriate for us to be discussing targets specifically, but I think we can talk about areas and indications that might be of some interest, but I do not think we will be target specific.
Operator
We will take a followup question from Shiv Kapoor with Morgan Joseph & Company.
Shiv Kapoor - Morgan Joseph & Company
One quick question on SAR3419. It seems the key difference between the phase I that was started in 2007 and the one that was recently started in France was a weekly administered drug versus three times weekly.
Can you talk about if you have actually determined MTD from the 2007 studies based on which Sanofi has started this weekly administered study?
Daniel M. Junius
Shiv, first of, we do not have access to the 2007 study, so we do not know if they are at MTD. We do not have that data that Sanofi controls, but maybe John could just comment, because it is a different dosing regimen, and give you some thoughts around the approaches we have seen, maybe not specifically in 3419 but in other compounds, where we have used a variety of dosing regimens.
John M. Lambert
I can’t tell you the results, but I can tell you in general that it was always planned before the first patient was dosed to do two studies; one dosing once every 3 weeks and another weekly. Indeed with AVE963, this was the plan.
This is something we have done with our compounds. Essentially, these are to learn in phase I what is the better dosing regimen, and you can seen that Genentech did the same thing with T-DM1, so this is essentially a preplanned approach.
Shiv Kapoor - Morgan Joseph & Company
Jim, don’t want to put you on the spot, but if you are there, you recently made a choice to join ImmunoGen, perhaps you can tell us what factors led you to joining ImmunoGen.
John M. Lambert
What factors? I was just asked this question the other day, if I moved to the Boston area for personal reasons or for ImmunoGen, and I said absolutely, the answer was ImmunoGen.
Otherwise, I probably would have stayed comfortably located in New Jersey at Bayer, so it was arduous journey coming here. I would say based on my experience that after having participated in at least probably 10 due diligences between both Pfizer and Bayer and also probably interviewing at 10 smaller companies, without a doubt, ImmunoGen had the right mix that was perfect for me and held the most promise in terms of real drugs for the future.
Operator
There are no more questions in the queue at this time. Ms.
Hausner, I would like to turn the call back over to you for your additional closing remarks.
Carol Hausner
Thank you very much. I appreciate your attention, and if you have any additional questions, be sure to call me at 781-895-0600 and have a good evening.
Operator
That does conclude today’s conference. We appreciate your participation and you may disconnect at this time.