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, 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.
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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
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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.
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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,
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
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