Abbi Adest submits: BioVex Group Inc, a Massachusetts based biotech company, filed an S-1 last Tuesday. The proposed ticker will be (NASDAQ: BVEX). The following are key details from their SEC filing:
We are a clinical-stage biotechnology company focused on the development and future commercialization of targeted treatments for cancer and the prevention of infectious disease. Our pipeline of cancer product candidates is built on what we believe to be a first-in-class oncolytic virus technology that replicates and spreads within solid tumors, causing the death of cancer cells while leaving surrounding healthy cells unharmed. We believe that this technology, which we refer to as OncoVEX, is more effective than earlier-generation clinical-stage oncolytic viruses and has the potential to establish a new standard of care in the treatment of solid tumors by improving overall survival rates while minimizing side effects. In particular, we believe that OncoVEX has the potential to:
• eliminate or shrink a broad range of tumors;
• prevent or slow the further growth of tumors;
• increase the proportion of tumors that can be surgically removed;
• limit the spread, or metastasis, of tumors from their initial site;
• increase the proportion of tumors that respond to other therapies, including chemotherapy and
• reduce the incidence of relapse.
In a completed Phase I clinical trial conducted in the United Kingdom in 30 patients with breast, melanoma, head and neck, or gastrointestinal tumors, our lead product candidate OncoVEXGM-CSF destroyed tumors while leaving normal tissue undamaged, and without the serious side effects associated with chemotherapy or radiation. OncoVEXGM-CSF is currently in a 14-patient Phase I/II clinical trial in the United Kingdom for the treatment of head and neck cancer, which we intend to expand with 14 additional patients in the highest dose group. In addition, OncoVEXGM-CSF is in a 50-patient Phase II trial in the United States for the treatment of melanoma. Preliminary data from the initial patients enrolled in both studies indicate shrinkage of treated tumors consistent with that observed in our Phase I clinical trial. Assuming that the results of our clinical trial in head and neck cancer continue to be positive, we intend to meet with the U.S. Food and Drug Administration, or FDA, in the second half of 2007 to seek agreement on the design of a pivotal Phase III clinical trial to be governed by a Special Protocol Assessment.
We expect to begin additional clinical trials in the United States with OncoVEXGM-CSF in pancreatic cancer in the third quarter of 2006 and in metastatic colorectal cancer affecting the liver by the end of the year. We intend to analyze the data from our pancreatic, colorectal liver metastases and melanoma clinical trials in late 2007 and early 2008 to determine whether to pursue pivotal Phase III clinical trials in these indications. Our research also suggests that our technology may have applications in other cancers, including primary liver and lung cancers and glioma, a form of brain cancer. In preclinical studies, OncoVEXGM-CSF caused tumor destruction in all of the more than 25 cell lines from 8 different types of cancer we have tested.
Key Financial Details:
Revenues: We have a limited operating history and have not yet commercialized any products or generated any product revenues. As of March 31, 2006, we had an accumulated deficit of $48.6 million. We have incurred losses in each year since we began operations, with net losses of $7.8 million in fiscal year 2004, $11.7 million in 2005 and $14.3 million in 2006. We expect to continue to incur significant and increasing operating losses for at least the next several years as we continue our research activities concerning oncolytic viruses and other biologics, conduct development of, and seek regulatory approvals for, OncoVEXGM-CSF or our other product candidates, and potentially commercialize any approved products.
Notable Issues to Watch For:
Failure to receive orphan product designation or exclusivity for company's products: Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs and biologics for relatively small patient populations as “orphan” products. In the United States, a drug or biological product may receive orphan designation if the product is intended to treat a rare disease or condition that affects fewer than 200,000 people in the United States, or more than 200,000 people and there is no reasonable expectation that the cost of development will be recovered from sales in the United States...We intend to seek orphan designation for our product candidates that meet the criteria in the relevant jurisdiction, but there is no guarantee that we will obtain such designation for any product.
Generally, if a product with an orphan designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a seven-year period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug or biologic for the same indication for that time period...Even if we obtain orphan product exclusivity for one of our product candidates, we may not be able to maintain it. For example, if a competitive product that is the same as our product is shown to be clinically superior to our product, any orphan exclusivity we have obtained will not block the approval of that competitive product.
Underwriters: Janney Montgomery Scott llc, Stifel Nicolaus