NEW YORK (GenomeWeb News) – Molecular diagnostics firm AutoGenomics has filed a preliminary prospectus with the US Securities and Exchange Commission to float an unspecified number of common shares in an initial public offering on the Nasdaq Global Market.
The firm did not offer an estimated price range for the shares in the offering or a preliminary estimate of net proceeds. However, the filing lists the proposed maximum aggregate offering price at $86.3 million.
Autogenomics makes the Infiniti molecular diagnostics system, which was cleared by the US Food and Drug Administration for marketing in February 2007. The firm currently offers 26 test applications on the system, including research-use-only tests for HPV, respiratory illness, breast and bladder cancer risk, and cystic fibrosis. The Carlsbad, Calif.-based company also has FDA clearance for a warfarin sensitivity test and for Factor II, Factor V, and Factor II-V panel tests.
According to its prospectus, AutoGenomics had an installed base of 58 Infiniti analyzers in reference labs, hospital labs, and specialty clinics throughout North America. Its customers include ARUP Laboratories, Cleveland Clinic, The Johns Hopkins Hospital, and the Montreal Heart Institute, among others.
AutoGenomics intends to discuss with the FDA in an upcoming meeting the design of a clinical trial for its human papillomavirus screening test, and it estimates that the PMA process for such a test could take two to three years or longer. It also intends to submit a 510(k) with the FDA next year for its HPV genotyping test.
The firm said that it would use proceeds from the offering to fund clinical studies on the HPV screening test and for other R&D activities, as well as for additional working capital and general corporate purposes.
For fiscal 2007, AutoGenomics had product sales of $1.6 million and a net loss of $9.3 million.
As of March 31, the firm had cash and cash equivalents of $9.3 million.
JP Morgan Securities is sole book-running manager for the offering. Deutsche Bank Securities is co-lead manager, and Pacific Growth Equities and Robert W. Baird are acting as co-managers.