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Biotech / Medical
Immunicon Corporation (IMMC)
An SI Board Since April 2004
Posts SubjectMarks Bans Symbol
12 2 0 IMMC
Emcee:  michael_f_murphy Type:  Unmoderated
S-1

We are developing and commercializing proprietary cell-based research and diagnostic products with an initial focus on cancer. We believe that our products can provide significant clinical benefits by giving physicians better information to understand, diagnose, treat and monitor cancer. Our technologies, which we brand as CellTracks, can identify, count and characterize a small number of tumor cells present in a blood sample from a patient. Our collaborator, Veridex, LLC, or Veridex, a Johnson & Johnson company, received 510(k) clearance from the US Food and Drug Administration, or FDA, in January 2004 for use of the CellSearch Epithelial Cell Kit, which incorporates our technologies, in the management of metastatic breast cancer (breast cancer that has spread beyond the primary tumor). We expect that the CellSearch Epithelial Cell Kit, which is currently available for sale for research purposes only, will be the initial diagnostic product launched by Veridex based on our technologies. We believe that our products and underlying technology platforms have other applications in cancer diagnostics, in the clinical development of cancer drugs and in cancer research, which we would commercialize under the terms of our agreement with Veridex. In addition, we believe that our proprietary technologies may have applications in other fields of medicine, such as cardiovascular and infectious diseases, which we could pursue on our own or with a commercial partner.

Our products are intended for use as an integrated system, consisting of kits containing reagents (chemically active substances) for use with our instruments and other system components that enable scientists, physicians and laboratories to collect, isolate, label, count and analyze tumor cells in the blood, known as circulating tumor cells, or CTCs. CTCs can appear in extremely low number, sometimes as few as one or two CTCs in a test tube of blood that contains billions of cells of various types. Our clinical trials results suggest that the presence of even a few CTCs in a blood sample is biologically and clinically important, as it predicts whether a therapy is likely to offer benefit to the patient.

Based on findings from our pivotal clinical trial and research studies, we believe that our products can enable physicians to predict the likely time to disease progression and survival in cancer patients more accurately and earlier than existing methods. As a result, the physician may be able to:

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more effectively select an appropriate cancer therapy;

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better monitor the effectiveness of ongoing treatment;

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change from ineffective cancer therapies sooner; and

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reduce overall treatment costs.

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Moreover, we believe that our products address many of the limitations of currently available cancer diagnostic and research methods and provide physicians and patients with the following benefits:

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a minimally invasive sample collection procedure based on a standard blood draw;

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ease of administration relative to imaging techniques such as CT and MRI scans; and

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potentially improved patient outcomes, including quality of life, time to disease progression and survival.

Our research studies suggest that our technologies can detect CTCs in certain solid tumor cancers in addition to breast cancer, specifically prostate, colorectal, lung and ovarian cancers. Based on these results, we are conducting or planning additional research studies and clinical trials designed to verify prior studies and support additional regulatory submissions. Based on the results from our internal research, we are also now in the early stages of developing a product based on our existing platforms that is designed to detect and analyze endothelial cells in blood. Endothelial cells, which are types of cells that make up the inner lining of blood vessels, are believed to play an important role and have diagnostic utility not only in cancer, but also in autoimmune disorders (diseases caused by the body's own immune system) and cardiovascular diseases. We are also exploring the potential of our technologies to develop products that can detect pathogens in the blood, such as fungi, that may be useful in the diagnosis of certain infectious diseases.

OUR COMMERCIALIZATION PLANS

To support commercialization of our products, we entered into a development, license and supply agreement with Veridex, under which Veridex has exclusive worldwide rights in the field of cancer to make and commercialize any cellular analysis products based on our technologies. Under the agreement with Veridex, Veridex is obligated to pay us approximately 30% of their net sales from the sale of reagents, test kits and certain other consumable and disposable items incorporating our technologies. Unless earlier terminated, this agreement has an initial term of 20 years and will be automatically renewed for three-year terms. There are various conditions that allow either party to terminate the agreement, including a material breach by either party or by mutual agreement. Veridex may terminate this agreement with or without reason at any time with 24 months' prior written notice. In addition, prior to shipment for commercial sale of the first diagnostic product resulting from this agreement, Veridex may terminate this agreement by providing us with 180 days' prior written notice. If a major competitor in the in vitro diagnostic, or IVD, field acquires us, Veridex also may terminate this agreement.

We and Veridex are currently marketing the following products, initially for research use only, or RUO, as a system and not as stand-alone products:

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CellSearch Epithelial Cell Kit, consisting of reagents and other supplies for isolating and labeling of CTCs;

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CellTracks AutoPrep System, an automated instrument to process blood samples prior to analysis;

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CellSpotter Analyzer, a semi-automated fluorescence microscope used to count and characterize cells; and

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CellSave Preservative Tube, a blood sample collection tube with preservative to collect and preserve blood samples for analysis.

All of these products have received FDA clearance for IVD use.

We and Veridex plan to launch these products for IVD use in the third quarter of 2004. This launch is subject to the submission by Veridex and clearance of a 510(k) for the CellSearch Epithelial Cell Control, which consists of two levels of controls required to be run daily to ensure our integrated system is operating properly. We believe that Veridex intends to submit the 510(k) for these controls in the second quarter of 2004. In addition, we expect that the CellSearch Profile Kit, consisting of reagents and supplies for isolating epithelial cells (cells that cover external and internal body surfaces and give rise to the majority of solid tumors) for molecular analysis, will be available for RUO in the second quarter of 2004. We also expect that the CellTracks Large Volume Sample Preparation System, or LVSP System, for pre-processing large blood samples, consisting of an instrument, reagents, and proprietary disposables, will be available for sale in the second half of 2004. We believe that this system is necessary to develop certain clinical indications for our products in early stages of cancer, detection of cancer recurrence, cancer risk assessment and screening applications.

In connection with the 510(k) clearance for the CellSearch Epithelial Cell Kit using our CellSpotter Analyzer, the FDA established a new classification of medical devices under its "de novo", or new, device review process. We anticipate that most of our initial products will be covered under this classification, which will be incorporated into the Code of Federal Regulations. This classification includes systems for selecting and counting CTCs, which are intended for use in conjunction with other diagnostic methods for monitoring or predicting cancer disease progression, response to therapy and the detection of recurrent disease. We believe this classification will cover most of our anticipated future cancer products, with the exception of products for cancer screening. Any future products covered by this new classification would be designated as Class II versus Class III devices by the FDA, and therefore, may be reviewed through the 510(k) submission process, as opposed to the more expensive and lengthy pre-market approval, or PMA, process for Class III devices.

OUR SOLUTION

We believe that the ability to predict survival in metastatic breast cancer with our technologies represents a potential breakthrough in cancer disease management. We believe that our products will help to address the following clinical needs:

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early diagnosis of cancer;

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effective tools for more complete diagnosis, staging and selection of primary therapy;

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effective monitoring of post-surgical and metastatic disease therapies; and

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early detection of recurrence and selection of appropriate therapies following recurrence.

Additionally, we believe that our products will provide pharmaceutical and biotechnology companies working on new cancer drugs with timely information on the performance of these drugs, which may shorten the drug development process. For instance, in early drug trials, we believe that the analysis of CTCs will help drug companies to select the right patient population in which to test a new drug and provide early and reliable information on the efficacy of this drug. The FDA evaluates efficacy of new drugs or drug combinations based on patient survival and/or certain accepted surrogate endpoints, such as a significant decrease in tumor burden (the total amount of tumor mass in the patients body) as assessed by imaging studies. Although we believe additional clinical data will be required to validate CTCs as a surrogate endpoint to the satisfaction of the FDA, we believe that CTCs may serve as an alternative to survival or costly imaging studies as a drug trial endpoint. Such a surrogate endpoint may permit shorter and less costly late-stage drug trials, and potentially bring new cancer therapies to the market sooner.

OUR STRATEGY

Our goal is to be a leader in the development and commercialization of proprietary cell analysis products that deliver high impact clinical and scientific information for use in human diagnostics, life science research and pharmaceutical development. The key elements of our strategy are to optimize the value of our proprietary technologies and maximize long-term profitability by:

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developing and commercializing cancer research and diagnostic products;

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developing multiple indications for each of our cancer diagnostic products;

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expanding the applications of our technologies to other fields of medicine in addition to cancer;

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seeking commercialization partners for our non-cancer product candidates; and

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continuously improving our products and technologies to remain competitive.

RISKS ASSOCIATED WITH OUR BUSINESS

We are a development-stage company. Accordingly, our business plan is subject to numerous risks and obstacles, including those that we highlight under "Risk factors." In particular, we have a limited operating history and have incurred substantial losses since inception. We incurred net losses of approximately $17.6 million for the year ended December 31, 2003, and our total deficit incurred from our inception in 1983 through December 31, 2003 was approximately $63.6 million. Our revenue to date has been derived principally from license revenue rather than from product sales or other revenue sources. From the inception of our agreement with Veridex in August 2000 through December 31, 2003, we recognized license revenue of $4.0 million in milestone receipts from Veridex. For the years ended December 31, 2002 and 2003, we recognized $311,000 and $338,000, respectively, as other revenue from certain government-sponsored research grants and from the sale of miscellaneous products to research and other organizations. We have very limited sales of commercial products, and we anticipate that we will incur substantial losses in the future and we may never achieve and maintain profitability. Moreover, we are dependent on the efforts of Veridex, which we do not control, for marketing of the cancer products based on our technologies. We do not know whether Veridex will market these products effectively, whether adequate levels of third-party reimbursement will be available for these products, or whether these products will sell well in the marketplace.

OUR CORPORATE INFORMATION

We incorporated in the Commonwealth of Pennsylvania as Immunicon Corporation in August 1983. In December 2000, we merged with and into Immunicon Corporation, a Delaware corporation. Our principal executive offices are located at 3401 Masons Mill Road, Suite 100, Huntingdon Valley, Pennsylvania 19006, and our telephone number is (215) 830-0777. Our web site address is www.immunicon.com. We do not intend for the information contained on our website to be incorporated by reference into, or to form any part of, this prospectus.
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12Immunicon Achieves Endpoints in its Pivotal Clinical Trial in Metastatic Colorectnsaf-9/26/2006
11Yeah, that's what got me back looking, thanks. Cheers, Tucktuck-8/12/2006
10value line just published a special report on it as well.mopgcw-8/12/2006
9Anybody still around? The shares have come up from the $3s to the mid $4s on thtuck-8/12/2006
8<lol> yes it is and its time for it to turn around now. I'm full.<gFizz-12/30/2004
7dude, wake up, it closes at 6.81 today ... is it cheap enough for you ???blind-geezer-12/29/2004
6Please smack me to buy some more if this gets back to the 7's. Had several cFizz-9/23/2004
5Leg: This morning, Immunicon reported a 2Q04 loss per share of $0.39. Our estimamopgcw-7/29/2004
4[HER-2 gene amplification can be acquired as breast cancer progresses] >>tuck-6/14/2004
3Webmaster email broken also : I give up. Recipient: <webmaster@siliconinvestmichael_f_murphy-6/3/2004
2Redirected the other one here. SI asked to delete the other one. The Customer Semichael_f_murphy-6/2/2004
1There are two threads you created. You might want to delete one so everybody is Fizz-6/2/2004
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