BLOOMFIELD, N.J., March 21 /PRNewswire-FirstCall/ -- Alfacell Corporation , today reported financial results and key developments from the second quarter of the Company’s fiscal year, which ended on January 31, 2006.
“We made significant progress during the second quarter of 2006,” stated Kuslima Shogen, Chief Executive Officer of Alfacell. “As a result, we continue to track on or ahead of schedule on key sections of the rolling NDA. We also remain confident that we will successfully complete all regulatory requirements necessary to gain marketing approval of ONCONASE in the U.S., E.U. and other markets.”
Financial Results
During the second quarter, Alfacell recorded a net loss of $2,286,000 or $(0.06) per common share, as compared to a net loss of $1,955,000 or $(0.06) per common share for the same period in FY 2005. The net loss for the second quarter includes a non-cash charge of $436,000 which reflects the accounting for share based payment as required by SFAS 123(R). The share-based compensation expense is expected to continue as a result of the adoption of SFAS 123(R), which requires the Company to charge a non-cash compensation expense for all employee stock options.
Research and development expenses for the three months ended January 31, 2006 totaled $1,430,000 compared to $1,554,000 for the same period last year, a decrease of $124,000, or 8%. The spending decrease reflects the near- completion of key requirements for the Chemistry, Manufacturing and Controls (CMC) section of the ONCONASE NDA for UMM, including toxicology studies, the registration batch stability program and a reduction in clinical trial costs as a result of reaching full patient enrollment.
General and administrative (G&A) expenses for the three months ended January 31, 2006 were $880,000 compared to $422,000 for the same period last year, an increase of $458,000, or 109%. This increase was primarily due to an increase in non-cash expense related to share-based compensation, higher legal fees, ongoing cost of Sarbanes-Oxley compliance and auditing fees.
Alfacell ended the second quarter of 2006 with cash, cash equivalents, and investments of $2,917,000. Total shares outstanding were 37,390,062 million.
Key Developments * Announced that Tommy G. Thompson, former Secretary of the U.S. Department of Health and Human Services and four-term Governor of Wisconsin, joined the Company as Chairman of the Alfacell Business Policy Committee, which will focus on advancing and executing strategies in areas such as finance, government relations, and regulatory affairs. * Announced expectation to reach the full patient enrollment target for the ONCONASE Phase IIIb trial ahead of the previously announced timeframe of end of first quarter 2006. * Formed a new Thoracic Cancer Advisory Board (TCAB) to support the development of ONCONASE and other novel ribonuclease (RNase) therapies for diseases such as mesothelioma and non-small cell lung cancer (NSCLC). * Initiated the manufacturing stability program for registration batches of ONCONASE. About Alfacell Corporation
Alfacell Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer and other diseases, using its ribonuclease (RNase) technology platform. ONCONASE(R) (ranpirnase), Alfacell’s lead investigational drug candidate, is currently being evaluated in several studies, including a Phase IIIb registration study for malignant mesothelioma (MM) and a Phase I / II trial in Non-Small Cell Lung Cancer (NSCLC). For more information, please visit www.alfacell.com.
This press release includes statements that may constitute “forward- looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainties involved in transitioning from concept to product, uncertainties involving the ability of the Company to finance research and development activities, potential challenges to or violations of patents, uncertainties regarding the outcome of clinical trials, the Company’s ability to secure necessary approvals from regulatory agencies, dependence upon third-party vendors, and other risks discussed in the Company’s periodic filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Contact: Alfacell Corporation: Investor/Media Relations: Kuslima Shogen Elite Financial Communications Robert Love Dodi Handy (973) 748-8082 (407) 585-1080 info@alfacell.comacel@efcg.net
Alfacell Corporation
CONTACT: Kuslima Shogen, or Robert Love, both of Alfacell Corporation,+1-973-748-8082, info@alfacell.com; or Dodi Handy of Elite FinancialCommunications, +1-407-585-1080, acel@efcg.net, for Alfacell Corporation
Web site: http://www.alfacell.com//
