SOMERSET, N.J., March 7 /PRNewswire-FirstCall/ -- Alfacell Corporation
(Nasdaq: ACEL) today reported its financial results for the second quarter
of fiscal 2008.
The company recorded a net loss of approximately $1.7 million, or $0.04
per basic and diluted common share, for the second fiscal quarter ended
Jan. 31, compared to a net loss of $1.9 million, or $0.04 per basic and
diluted common share, for the second quarter of fiscal 2007. The increased
research and development expenses of approximately $0.6 million and general
and administrative expenses of approximately $0.4 million were offset by an
increase in the company's state tax benefit of approximately $1.2 million,
during the second quarter of fiscal 2008 as compared to the same quarter a
year ago.
Net loss for the first half of fiscal 2008 of approximately $4.4
million, or $0.10 per basic and diluted common share, represents an
increase of approximately $0.1 million, compared to the $4.3 million net
loss, or $0.10 per basic and diluted common share, for the first half of
fiscal 2007. The increased net loss in the first half of fiscal 2008 is
comprised of increased research and development expenses of approximately
$0.6 million and increased general and administrative expenses of
approximately $0.7 million, which were offset by increased proceeds from
the sale of state tax benefit of approximately $1.2 million versus the same
period in fiscal 2007.
Cash and Liquidity
As of Jan. 31, the company had cash and cash equivalents of
approximately $10.2 million, an increase of approximately $4.8 million,
compared to cash and cash equivalents of approximately $5.4 million on Oct.
31, 2007. The company believes that this level of cash and cash equivalents
is sufficient to support its activities through the fourth quarter of
fiscal year 2009, based on the current expected level of receipts and
expenditures.
"We are extremely pleased with the progress made at Alfacell during the
most recent fiscal quarter," said Kuslima Shogen, Alfacell's chief
executive officer. "We have made considerable progress towards the
completion of our rolling NDA and we have entered into key partnerships to
promote and prepare for the successful commercialization of ONCONASE(R)."
Clinical Trials Update
Alfacell has completed patient enrollment in the confirmatory Phase
IIIb clinical trial for ONCONASE (ranpirnase) in patients suffering from
unresectable malignant mesothelioma. The company plans to begin the
required statistical analysis of the data generated by the trial after 316
evaluable events have occurred. A total of 313 evaluable events have
occurred to date.
Commercial Update
In January, Alfacell entered into two new agreements for the
commercialization of ONCONASE, including:
-- an exclusive license agreement with Par Pharmaceutical, Inc. for the
commercialization of ONCONASE in the U.S. by Strativa, the branded
product division of Par. As part of the agreement, Alfacell received a
cash payment of $5 million as a non-refundable up-front fee and is
eligible to receive additional cash milestones as well as royalties on
net sales.
-- a marketing and distribution agreement with BL&H Co. Ltd., for the
commercialization of ONCONASE in Korea, Taiwan and Hong Kong. Under
the agreement, Alfacell received a $0.1 million non-refundable up-front
fee and is eligible to receive additional cash milestones and 50% of
net sales in the territory.
Conference Call & Webcast
Alfacell will host a conference call and Webcast to discuss the
financial results at 11 a.m. EST on Friday, March 7. To participate in the
live conference call, U.S. residents may dial 1-877-407-9205, and
international callers may dial 1-201-689-8054. A replay of the call will be
available until March 14. To access the replay, U.S. residents may dial
1-877-660-6853, and international callers may dial 1-201-612-7415 and enter
account number 286 and conference ID number 276752. A live Webcast and
replay of the conference call will be available on Alfacell's Web site at
http://www.alfacell.com.
About ONCONASE(R)
ONCONASE is a first-in-class therapeutic product candidate based on
Alfacell's proprietary ribonuclease (RNase) technology. A natural protein
isolated from the leopard frog, ONCONASE has been shown in the laboratory
and clinic to target cancer cells while sparing normal cells. ONCONASE
triggers apoptosis, the natural death of cells, via multiple molecular
mechanisms of action.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a
biopharmaceutical product candidate that works in a manner similar to RNA
interference (RNAi) through late-stage clinical trials. The product
candidate, ONCONASE, is an RNase that overcomes the challenges of targeting
RNA for therapeutic purposes while enabling the development of a new class
of targeted therapies for cancer and other life-threatening diseases. In
addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell
is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer
(NSCLC) and other solid tumors. For more information, visit
http://www.alfacell.com.
Safe Harbor
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 the outcome of the company's ongoing Phase IIIb
clinical trial for its lead product, the company's ability to secure
necessary approvals from regulatory agencies, uncertainties involving the
ability of the company to finance research and development activities and
its ongoing operations, potential challenges to or violations of patents,
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.
ALFACELL CORPORATION
Condensed Statements of Operations
Three-Months Ended Six-Months Ended
January 31 January 31
2008 2007 2008 2007
Revenues $- $- $- $-
Expenses:
Research and
development 2,033,500 1,472,578 3,649,291 3,042,763
General and
administrative 1,473,736 1,061,743 2,645,252 1,987,781
Total expenses 3,507,236 2,534,321 6,294,543 5,030,544
Loss from operations (3,507,236) (2,534,321) (6,294,543) (5,030,544)
Interest income, net 64,807 98,539 125,314 221,826
State tax benefit 1,755,380 510,467 1,755,380 510,467
Net loss $(1,687,049) $(1,925,315) $(4,413,849) $(4,298,251)
Net loss per share-
basic and diluted $(0.04) $(0.04) $(0.10) $(0.10)
Shares used in
computation of net
loss per share:
Basic and diluted 46,861,347 44,846,064 46,645,663 44,595,902
Balance Sheet Data:
January 31, July 31,
2008 2007
Cash and cash equivalents $10,207,924 $6,968,172
Total assets $11,194,580 $7,820,499
Current liabilities $2,163,216 $1,829,900
Accumulated deficit $(96,485,604) $(92,071,755)
Total stockholders equity $3,622,340 $5,778,480
Media Contact: Investor Contact:
David Schull or Wendy Lau Timothy Engel
Russo Partners Russo Partners
212-845-4271 212-845-4242
David.Schull@russopartnersllc.com Timothy.Engel@russopartnersllc.com
Wendy.Lau@russopartnersllc.com
SOURCE Alfacell Corporation
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Related links:
http://www.alfacell.com
CONTACT:
Media: David Schull,
David.Schull@russopartnersllc.com, or Wendy Lau,
Wendy.Lau@russopartnersllc.com, +1-212-845-4271, or Investors:
Timothy Engel, +1-212-845-4242,
Timothy.Engel@russopartnersllc.com, all of Russo Partners for
Alfacell Corporation
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