Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ: POTP) today reported
financial results for the fiscal quarter ended March 31, 2005. Point
reported a net loss of $4,915,000 or $0.25 per share, in the first
quarter of 2005, compared with a net loss of $3,135,000, or $0.21 per
share, in the first quarter of 2004.
During the first quarter of 2005, the Company achieved several
important milestones:
-- Completed the first stage of a two-stage study in the
Company's Phase 2 single-agent trial of talabostat in patients
with advanced metastatic melanoma
-- Raised $16.4 million though a registered direct placement of
3,650,000 shares of the Company's common stock
-- Announced that Thomas F. Gajewski, MD, PhD, Associate
Professor in the Department of Pathology and Medicine at the
Ben May Institute and leader of the Immunology and Cancer
Program at University of Chicago Cancer Research Center,
joined Point's Clinical Advisory Board
"The first quarter of 2005 was an important one for the Company,"
said Donald R. Kiepert, Jr., President and Chief Executive Officer.
"We achieved the first stage of a two-stage study in our Phase 2
single-agent trial of talabostat in patients with advanced metastatic
melanoma, allowing us to move this trial forward to its next stage. We
were also successful in raising $16.4 million, positioning the Company
solidly to further our clinical program. Currently, we are conducting
four Phase 2 clinical trials in advanced metastatic melanoma,
non-small cell lung cancer and chronic lymphocytic leukemia, and we
expect to initiate a fifth Phase 2 study in pancreatic cancer by the
end of the second quarter. Importantly, we also recently announced
that we intend to initiate a Phase 3 pivotal program in non-small cell
lung cancer later this year."
Research and development expenses increased to $3,553,000 in the
first quarter of 2005, from $2,026,000 in the first quarter of 2004.
The increase in research and development costs resulted primarily from
increased clinical and related manufacturing costs pertaining to the
Company's four ongoing Phase 2 clinical trials. General and
administrative expenses increased to $1,444,000 in the first quarter
of 2005 from $1,128,000 in the first quarter of 2004. The increase in
general and administrative expenses resulted primarily from increased
salaries, annual bonuses and related costs for three new hires.
Point's cash and investment balance as of March 31, 2005 was
$25,224,000. On March 4, 2005, Point received $16,425,000 in gross
proceeds relating to the sale of 3,650,000 shares of common stock in a
registered direct placement of securities. Offsetting these proceeds
were costs totaling approximately $1,400,000 relating to the sale and
registration of the shares, resulting in net proceeds from the private
placement of approximately $15,000,000. Interest income was $81,000 in
the first quarter of 2005 compared to $19,000 in the first quarter of
2004. The increase in interest income was principally due to a higher
average cash balance and slightly higher interest rates in 2005
compared to 2004.
On April 28, 2005, the Company announced that it achieved the
desired tumor response criteria with its lead compound, talabostat, in
combination with docetaxel, in its Phase 2 Stage IIIb/IV non-small
cell lung cancer (NSCLC) clinical trial. These results allow Point to
move forward in planning its Phase 3 pivotal program for NSCLC, which
the Company intends to initiate later this year.
About Point Therapeutics, Inc.:
Point is a Boston-based biopharmaceutical company developing a
family of dipeptidyl peptidase (DPP) inhibitors for a variety of
cancers, certain hematopoietic disorders, type 2 diabetes and as
vaccine adjuvants. Their lead product candidate, talabostat (PT-100),
is a small molecule drug in Phase 2 clinical trials. Talabostat is
orally-active and, through a novel mechanism of action, has the
potential to inhibit the growth of malignant tumors and to accelerate
the reconstitution of the hematopoietic system. In 2004, Point
initiated four Phase 2 clinical trials of talabostat. The trials are
studying talabostat in combination with Taxotere(R) for the treatment
of advanced NSCLC, talabostat as a single agent to treat advanced
metastatic melanoma, talabostat in combination with cisplatin also to
treat advanced metastatic melanoma, and talabostat in combination with
rituximab to treat advanced chronic lymphocytic leukemia (CLL). The
Company is also studying talabostat in clinical trials to potentially
prevent both neutropenia and anemia. In addition, their portfolio
includes two other DPP inhibitors in preclinical development--PT-630
for type 2 diabetes, and PT-510 as a vaccine adjuvant.
Certain statements contained herein are not strictly historical
and are "forward looking" statements as defined in the Private
Securities Litigation Reform Act of 1995. This information includes
statements on the prospects for our drug development activities and
results of operations based on our current expectations, such as
statements regarding certain milestones with respect to our clinical
program and our product candidates. Forward-looking statements are
statements that are not historical facts, and can be identified by,
among other things, the use of forward-looking language, such as
"believes," "expects," "may," "will," "should," "seeks," "plans,"
"schedule to," "anticipates" or "intends" or the negative of those
terms, or other variations of those terms of comparable language, or
by discussions of strategy or intentions. A number of important
factors could cause actual results to differ materially from those
projected or suggested in the forward looking statement, including,
but not limited to, the ability of Point to (i) successfully develop
and manufacture products, (ii) obtain external funding to finance the
operations, (iii) obtain the necessary regulatory approvals, and (iv)
obtain and enforce intellectual property rights, as well as the risk
factors described in Point's 10-K, filed with the Securities and
Exchange Commission on March 15, 2005, and from time to time in
Point's other reports filed with the Securities and Exchange
Commission.
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POINT THERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Period from
September 3,
1996
(date of
inception)
Three months ended through
March 31, March 31,
2005 2004 2005
------------ ------------ ----------------
REVENUES
License revenue $ - $ - $ 5,115,041
Sponsored research
revenue - - 2,400,000
------------ ------------ --------------
Total revenues - - 7,515,041
------------ ------------ --------------
OPERATING EXPENSES
Research and development 3,552,984 2,025,617 35,776,379
General and
administrative 1,443,632 1,127,681 17,486,408
------------ ------------ --------------
Total operating
expenses 4,996,616 3,153,298 53,262,787
------------ ------------ --------------
Net loss from operations (4,996,616) (3,153,298) (45,747,746)
Interest income 81,271 18,786 1,220,623
Interest expense - - (82,652)
------------ ------------ --------------
Net loss $ (4,915,345) $(3,134,512) $ (44,609,775)
============ ============ ==============
Basic and diluted net loss
per common share $ (0.25) $ (0.21)
============ ============
Basis and diluted weighted
average common shares
outstanding 19,439,848 15,168,907
============ ============
POINT THERAPEUTICS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
March 31, December 31,
2005 2004
------------ ------------
ASSETS
Cash, cash equivalents and marketable
securities $25,223,841 $13,991,994
Property and equipment, net 193,270 205,323
Other assets 827,716 298,758
----------- -----------
Total assets $26,244,827 $14,496,075
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 3,052,080 $ 2,397,814
Other liabilities 47,604 47,604
Total stockholders' equity 23,145,143 12,050,657
----------- -----------
Total liabilities and stockholders' equity $26,244,827 $14,496,075
=========== ===========
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