It might have been a tight squeeze, but Xcyte Therapies Inc. got through the initial public offering window, pricing 4.2 million shares at $8 per share to raise $33.6 million - significantly lower than the range set earlier, and even further below the $75 million the company said in October it hoped to raise.
After-market performance wasn't much to cheer about, either. The firm's stock (NASDAQ:XCYT) closed Tuesday at $7.31, and slid still more Wednesday, ending at $6.92, down 39 cents.
Almost two years after withdrawing its first IPO filing that aimed to raise $86.2 million, Xcyte tried again last fall, shooting for $75 million. But in February the company revised its plan, predicting 4 million shares at a range between $13 and $15, which at the upper limit would have garnered $60 million. (See BioWorld Today, Oct. 14, 2003.)
The company's Xcellerate technology makes drugs from a patients own T cells in the blood, activating and expanding them outside the body, stimulating them to carry out immune functions and then administering them back to the patient.
Though still in the quiet period that extends 25 days after pricing by the rule of the SEC, Xcyte disclosed details of its research and plans in the IPO prospectus - and the company has data galore.
Against chronic lymphocytic leukemia, Xcellerate technology in an ongoing Phase I/II trial yielded a 50 percent to 100 percent reduction in the size of enlarged lymph nodes in 10 of 11 patients evaluated so far, and there was a 50 percent or more reduction in spleen size as measured below the rib cage by physical examination in all 10 of the patients with enlarged spleens. Findings will be submitted to the FDA as part of the company's annual report, the prospectus noted.
Another ongoing Phase I/II trial in multiple myeloma has shown that treatment with Xcellerated T Cells led to rapid recovery of T cells and lymphocytes in all 32 patients evaluated so far.
The patients in the study are afflicted with multiple myeloma and have undergone treatment with high-dose chemotherapy and autologous stem cell transplants. Earlier independent clinical studies found a correlation between patient survival and the speed of recovery of lymphocytes after such treatment, and preliminary data from the first 25 patients evaluated for tumor responses show, in the majority of patients, a greater than 90 percent decrease in the tumor marker.
The company has not yet submitted those data to the FDA, pending follow-up to determine the effects of Xcellerated T Cells after transplant. In independent clinical trials, though, a tumor-marker decrease of greater than 90 percent has been associated with increased survival. Xcyte recently began a Phase II trial to treat patients who have advanced disease with Xcellerated T Cells without other antitumor therapy.
In December, Xcyte offered preliminary results from the CLL and multiple myeloma trials at the American Society of Hematology meeting in San Diego.
Other positive data with the company's treated T cells have emerged from an independent study in non-Hodgkin's lymphoma, published in the journal Blood last year. Results have been submitted to the FDA, and Xcyte plans a Phase II trial in the first half of this year in NHL patients who have failed other therapy.
A Phase I trial in 25 patients with kidney cancer yielded favorable data, published last year in Clinical Cancer Research and passed along to the FDA for review.
In prostate cancer, a recently finished Phase I/II trial showed a greater than 50 percent drop in the serum-tumor marker prostate-specific antigen in two of 19 patients.
In HIV, an independent study published two years ago in Nature Medicine showed an earlier version of Xcyte's technology-boosted T-cell counts and kept them normal for at least one year after therapy. Those data also are in the hands of the FDA.
The HIV work in January netted Xcyte a technology-transfer deal with Fresenius Biotech GmbH, a division of Fresenius AG, of Bad Homburg, Germany, for a T-cell-based gene therapy program for treating HIV infection. The agreement granted Fresenius an exclusive license to the Xcellerate technology in Europe for treating HIV/AIDS with gene-modified T cells and provides Xcyte with milestone and royalty payments.
In the IPO, Seattle-based Xcyte granted the underwriters an option for up to 630,000 more shares to cover overallotments. Piper Jaffray & Co., of Minneapolis, and RBC Capital Markets Corp., of New York, are acting as the lead managers of the offering, with co-managers listed as Wells Fargo Securities LLC and JMP Securities LLC, both of San Francisco.