Point Therapeutics, Inc. (NASDAQ: POTP) today reported financial
results for the fiscal quarter ended March 31, 2006. Point reported
a net loss of $7,857,000 or $0.24 per basic and diluted share in
the first quarter of 2006, compared with a net loss of $4,915,000,
or $0.25 per basic and diluted share, in the first quarter of 2005.
In the first quarter of 2006, Point achieved several important
milestones: -- Initiated a second Phase 3 clinical trial in
metastatic non-small cell lung cancer (NSCLC) to evaluate
talabostat in combination with pemetrexed versus pemetrexed with
placebo. The first Phase 3 trial studying talabostat in metastatic
NSCLC in combination with docetaxel versus docetaxel with placebo
was launched in October of 2005. -- Announced a collaboration with
the National Cancer Institute (NCI) to study talabostat in
combination with chemotherapy in pediatric patients with solid
tumors. The primary objectives of the Phase 1 study are to evaluate
the safety and dosing of talabostat in combination with
chemotherapy in the pediatric population. -- Continued Phase 2
studies in metastatic melanoma, advanced chronic lymphocytic
leukemia and metastatic pancreatic cancer. -- Presented data
further elucidating talabostat's novel dual mechanism of action
during a Company Research and Development Day. Preclinical studies
suggest that talabostat is an oral dipeptidyl peptidase (DPP)
inhibitor with anti-tumor activity achieved by targeting tumor
stromal fibroblast activation protein (FAP) and
macrophage-associated DPP 8 and DPP 9. Inhibition of FAP can
suppress tumor growth, and inhibition of DPP 8 and 9 can stimulate
innate and adaptive immune responses that kill tumor cells. "In
February, we achieved an important milestone when we enrolled the
first patient in our second Phase 3 trial in metastatic non-small
cell lung cancer," said Don Kiepert, President and CEO of Point
Therapeutics, Inc. "We were also pleased to launch a new Phase 1
study in pediatric solid tumors with the NCI. This is the first
time talabostat has been studied in children. In addition to our
clinical progress, Point has also made significant advancements in
further elucidating talabostat's mechanism of action, which we
presented during a Company Research and Development Day in April.
We believe that talabostat's stromal targeted activity through the
inhibition of FAP and immunostimulatory activity through the
inhibition of DPP 8 and DPP 9 create a new and exciting approach
for the treatment of cancer," concluded Kiepert. Revenues of
$139,000 were recorded in the first quarter of 2006 resulting from
a $600,000 Orphan Products Development grant which is funding a
portion of Point's current Phase 2 study combining talabostat with
rituximab in advanced chronic lymphocytic leukemia. Research and
development expenses increased to $6,318,000 in the first quarter
of 2006 from $3,553,000 in the first quarter of 2005. The increase
in research and development costs for the quarter resulted
primarily from costs associated with the company's two Phase 3
non-small cell lung cancer trials. General and administrative
expenses increased to $2,018,000 in the first quarter of 2006 from
$1,444,000 in the first quarter of 2005. The increase in general
and administrative expenses for the quarter resulted primarily from
costs for new hires and other expenses to support the company's
programs. Point's cash and investment balance as of March 31, 2006
was $30,992,000. Interest income was $341,000 in the first quarter
of 2006 compared to $81,000 in the first quarter of 2005. The
increase in interest income resulted from a higher average cash
balance and higher interest rates earned on invested balances. -0-
*T A conference call is schedule for today, May 9 at 4:30 PM EST.
U.S. & Canada toll-free dial in #: 800-299-0433 International
dial in #: 617-801-9712 Participant code: 23190397 Replay toll-free
dial in #: 1-888-286-8010 Replay international dial in #:
617-801-6888 Replay code: 69522614 *T About Point Therapeutics,
Inc.: Point is a Boston-based biopharmaceutical company developing
a portfolio of dipeptidyl peptidase (DPP) inhibitors for use in
cancer, type 2 diabetes and as vaccine adjuvants. Point is
currently studying its lead product candidate, talabostat, in two
Phase 3 trials in non-small cell lung cancer. Point is also
studying talabostat in several Phase 2 trials, including as a
single-agent in metastatic melanoma, in combination with cisplatin
in metastatic melanoma, in combination with rituximab in advanced
chronic lymphocytic leukemia, and in combination with gemcitabine
in metastatic pancreatic cancer. In addition, Point's 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 Annual Report on Form 10-K, filed with
the Securities and Exchange Commission on March 15, 2006, and from
time to time in Point's other reports filed with the Securities and
Exchange Commission. -0- *T 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, 2006 2005 2006 -------------
------------- ------------- REVENUES License revenue $ - $ - $
5,115,041 Sponsored research revenue 138,795 - 2,700,000
------------- ------------- ------------- Total revenues 138,795 -
7,815,041 ------------- ------------- ------------- OPERATING
EXPENSES Research and development 6,318,363 3,552,984 56,788,021
General and administrative 2,018,397 1,443,632 23,256,204
------------- ------------- ------------- Total operating expenses
8,336,760 4,996,616 80,044,225 ------------- -------------
------------- Net loss from operations (8,197,965) (4,996,616)
(72,229,184) Interest income 341,352 81,271 2,086,844 Interest
expense - - (82,652) ------------- ------------- ------------- Net
loss $ (7,856,613) $ (4,915,345) $(70,224,922) =============
============= ============= Basic and diluted net loss per common
share $ (0.24) $ (0.25) ============= ============= Basis and
diluted weighted average common shares outstanding 32,754,959
19,439,848 ============= ============= POINT THERAPEUTICS, INC. (A
Development Stage Company) CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED) March 31, December 31, 2006 2005 -------------
------------ ASSETS Cash, cash equivalents and restricted cash
$30,991,805 $37,634,230 Property and equipment, net 320,600 344,432
Other assets 2,015,562 2,421,937 ------------ ------------ Total
assets $33,327,967 $40,400,599 ============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities $
6,179,653 $ 5,954,544 Other liabilities 45,361 47,087 Total
stockholders' equity 27,102,953 34,398,968 ------------
------------ Total liabilities and stockholders' equity $33,327,967
$40,400,599 *T
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