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ImmunoGen Inc. (IMGN)
F2Q09 Earnings Call
January 29, 2009 4:30 pm ET
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
Shiv Kapoor – Morgan Joseph & Company
Jason Kantor – RBC Capital Markets
Pamela Bassett – Cantor Fitzgerald
Joel Sendek – Lazard Capital Markets
Previous Statements by IMGN
» ImmunoGen, Inc. F3Q09 (Quarter End 03/31/09) Earnings Call Transcript
» ImmunoGen, Inc. F1Q09, (Qtr End 9/30/08) Earnings Call Transcript
» ImmunoGen, Inc. F4Q08 (Qtr End 06/30/08) Earnings Call Transcript
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.