Message Font: Serif | Sans-Serif
No. of Recommendations: 0
Look for this stock to move in April, if not before. The ASCO annual meeting is May 13-17 in Orlando, and there is a BIO CEO & Investor Conference on Feb. 23 in NY.

CEO's Message February 3, 2005

This afternoon we issued our financial results for the second quarter of our 2005 fiscal year. I think you'll agree with me that these results are pretty impressive – we have lots of activities underway in support of our own compounds, and yet our operations were close to cash flow neutral because of our partnerships. This performance is a direct result of our business model, which is to develop a pipeline of our own products and to help pay for our product programs by outlicensing our Tumor-Activated Prodrug (TAP) technology to select other companies.

In December, the Centocor subsidiary of Johnson & Johnson licensed the right to use our TAP technology for an undisclosed target. As many of you know, Centocor is one of the world's three most successful antibody companies – the other two are Genentech and Biogen Idec, which have also licensed our technology. Seven major companies have now licensed rights to our TAP technology: Centocor, Biogen Idec, Genentech, the sanofi-aventis Group, Millennium Pharmaceuticals, Boehringer Ingelheim, and Abgenix.

These partnerships provide Wall Street with reasonable comfort that smart, independent parties are willing to spend millions of dollars to access our technology. Importantly, these partnerships increase our “shots on goal,” because our technology gets used with antibodies that are proprietary to other companies, and not otherwise available to us – antibodies like Genentech's Herceptin® and Millennium's anti-PSMA antibody. So, we can derive a financial return from TAP products that wouldn't otherwise exist.

The cash we've received from our partners over the past two quarters has covered virtually all of our operating costs, so we have had minimal cash burn so far this year. We started our 2005 fiscal year with $94.6 million in cash and marketable securities, and had $93.3 million in cash and marketable securities on December 31, 2004. During this same period, we made significant progress with our lead compounds, huN901-DM1 and huC242-DM4.

At the start of the fiscal year, we took over the Phase I/II study underway with our compound huN901-DM1 from our former partner, Vernalis. We have increased the pace of patient enrollment in this study, and we have submitted the findings to date for presentation at the annual meeting of the American Society of Clinical Oncology (ASCO). If accepted, we will report Phase II data on huN901-DM1 at the ASCO meeting in May.

All of the patients in the Phase II leg have the same type of cancer – relapsed small-cell lung cancer – and all receive the same dose of huN901-DM1 – 60 mg/m2. So, this is a more homogenous group of patients than was in the Phase I leg of this study, which included patients with carcinoid tumors and which used a number of different dosage levels.

I should note that Vernalis is making progress with the Phase I study currently ongoing in the U.K., so data should be reported from that study, too, at some point.

HuN901-DM1 also has potential utility in the treatment of hematological, or “liquid,” tumors. To examine this opportunity for the compound, we are implementing a study with huN901-DM1 in multiple myeloma. Our clinical department is working hard to get everything set with the study centers, and we expect patient dosing to begin soon. We'll let you know when that happens.

We're also making good progress with our huC242-DM4 compound and remain on track to begin clinical testing with it in mid-2005. We're confident in the design of huC242-DM4, and believe this compound will become an important treatment for CanAg-expressing cancers like colorectal and pancreatic cancer. An abstract on our preclinical findings with huC242-DM4 was accepted by the American Association for Cancer Research (AACR). These findings will be presented on April 17 at the AACR annual meeting in Anaheim, California. The presentation will include data on how huC242-DM4 compares with its predecessor, cantuzumab mertansine. We'll share the data with you once they have been presented.

In addition to our own anticipated achievements, in the coming months we also expect achievements by our partners. The sanofi-aventis Group is advancing the anti-CD33 TAP they licensed from us toward clinical testing and Millennium has indicated that they expect to report data on their TAP compound, MLN2704, at the ASCO annual meeting in May.

So, ImmunoGen is in excellent shape financially, we are making very good progress, and our partners are making solid progress as well. In the coming months, we expect:

· We will begin patient dosing in our clinical study with huN901-DM1 in the liquid tumor malignancy, multiple myeloma;

· The sanofi-aventis Group will begin patient dosing with their anti-CD33 TAP compound;

· We will present preclinical data on huC242-DM4 at the AACR annual meeting in April;

· Millennium will present new data on their MLN2704 TAP compound at the ASCO annual meeting in May;

· We will present Phase II data on our huN901-DM1 TAP compound at the ASCO meeting in May; and

· We will start patient dosing with huC242-DM4 in mid-2005.

A lot is happening, and I look forward to updating you on our progress.
Print the post  


When Life Gives You Lemons
We all have had hardships and made poor decisions. The important thing is how we respond and grow. Read the story of a Fool who started from nothing, and looks to gain everything.
Contact Us
Contact Customer Service and other Fool departments here.
Work for Fools?
Winner of the Washingtonian great places to work, and Glassdoor #1 Company to Work For 2015! Have access to all of TMF's online and email products for FREE, and be paid for your contributions to TMF! Click the link and start your Fool career.