Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ: POTP) today presented a quarterly
update on the Company’s progress and reported
financial results for the fiscal quarter and nine months ended September
30, 2006.
Point furthered and/or completed several key initiatives:
Continued enrollment into the Company’s two
randomized Phase 3 double blind placebo-controlled trials of
talabostat in patients with metastatic non-small cell lung cancer
(NSCLC) who have previously failed platinum-based therapies. The first
Phase 3 trial evaluates docetaxel (Taxotere®;
Sanofi-Aventis) with and without talabostat. The second Phase 3 trial
evaluates pemetrexed (Alimta®;
Eli Lilly) with and without talabostat. Both trials continue to accrue
patients and results from each trial are expected by the end of 2007.
In addition, the Company is currently recruiting study sites in Canada.
Undertook cost reduction measures to prioritize the use of capital
resources to complete the Company’s two
Phase 3 NSCLC clinical trials. These measures are projected to reduce
the Company’s FY 2007 operating expenses by
approximately $7.0 million, or 20%, from the projected operating
expenses for FY 2006. Cost reduction measures include deferring the
preclinical development of the Company’s
type 2 diabetes candidate, PT-630, focusing the Company’s
preclinical research efforts to primarily support the clinical
development of talabostat and continuing tight control over
discretionary spending. Along with these measures, the Company has
reduced its workforce by approximately 15%, primarily in the internal
preclinical research group. With these measures in place, the Company
currently forecasts that the quarterly cash spend for FY 2007 will be
approximately $6.0 million. The Company estimates that the total
charges for the cost reduction plan will be approximately $330,000.
Presented new preclinical data at two scientific meetings in the last
quarter. At annual meeting of the International Society for Biological
Therapy of Cancer Development (iSBTC) in Los Angeles, CA in October, a
study of talabostat conducted in the laboratory of Dr. Lee J. Helman,
in the Pediatric Oncology Branch of the National Institutes of Health,
was presented. This study demonstrated in an osteosarcoma model that
mice treated with talabostat had a four-fold decrease in the number of
primary tumors compared to saline treatment, and, in a separate
experiment in the study, that mice treated with talabostat had a
20-fold decrease in the number of gross metastatic lung nodules
compared to saline treatment. At the American Association for Cancer
Research Annual Meeting in September, a study of talabostat conducted
in the laboratory of Dr. Charles Dinarello, a Professor of Medicine at
the University of Colorado School of Medicine, was presented that
highlighted talabostat's ability to stimulate key cytokines in whole
blood cultures from healthy humans, particularly IL-1 alpha, which is
known to play an important role in immunostimulation.
“The Company continues to make progress with
our Phase 3 non-small cell lung cancer clinical trials. In our ongoing
efforts to further talabostat’s clinical
development, particularly our Phase 3 program, it became necessary for
Point to undertake measures to reduce our costs,”
said Don Kiepert, President and CEO. “These
decisions are always extremely difficult to make, but we believe that it
is in the best interest of the company for long-term success. We feel
strongly about the market potential of talabostat and, therefore, it is
extremely important to focus our current resources on advancing our
clinical programs. We greatly appreciate the contributions that each
departing employee has made to the Company, and we wish them great
success in the future,” added Kiepert.
Point reported a net loss of $7,826,000 or $0.24 per basic and diluted
share in the third quarter of 2006, compared with a net loss of
$6,716,000, or $0.29 per basic and diluted share, in the third quarter
of 2005. For the first nine months of 2006, Point reported a net loss of
$23,028,000 or $0.70 per share, compared with a net loss of $16,775,000
or $0.77 per share for the first nine months of 2005.
Research and development expenses increased to $6,731,000 in the third
quarter of 2006 from $5,637,000 in the third quarter of 2005. The
increase in research and development costs for the quarter resulted
primarily from external costs and new hires associated with the Company’s
two Phase 3 NSCLC studies. In addition, non-cash stock-based
compensation for employee options in accordance with SFAS No. 123R
contributed to the increase.
General and administrative expenses increased to $1,556,000 in the third
quarter of 2006 from $1,242,000 in the third quarter of 2005. The
increase in general and administrative expenses for the quarter resulted
primarily from non-cash compensation for employee and director stock
options in accordance with SFAS No. 123R and increased investor
relations and business development consulting costs.
Point's cash and investment balance as of September 30, 2006 was
$16,078,000. Interest income was $241,000 in the third quarter of 2006,
compared to $163,000 in the third quarter of 2005. The increase in
interest income resulted from higher interest rates.
A conference call is schedule for today, November 9, at 4:30 PM EST. A
re-broadcast of the conference call will be available until November 16,
2006.
Conference call information:
U.S. & Canada toll-free dial in #: 800-591-6944
International dial in #: 617-614-4910
Participant code: 66385651
Replay toll-free dial in #: 888-286-8010
Replay international dial in #: 617-801-6888
Replay code: 78019990
About Point Therapeutics, Inc.:
Point is a Boston-based biopharmaceutical company which is currently
studying its lead product candidate, talabostat, in two Phase 3 double
blind placebo-controlled trials in non-small cell lung cancer and in a
Phase 2 trial in combination with gemcitabine in metastatic pancreatic
cancer. Point has also studied talabostat in several Phase 2 trials,
including as a single-agent in metastatic melanoma, in combination with
cisplatin in metastatic melanoma and in combination with rituximab in
advanced chronic lymphocytic leukemia.
Certain statements contained herein are not strictly historical and
are "forward looking" statements as defined in the Private Securities
Litigation Reform Act of 1995. These statements include, without
limitation, statements with respect to the company’s
clinical development programs, the timing of initiation and completion
of its clinical trials, and the implementation of cost reduction plans,
including estimates related to the expense and future costs savings
associated with such plans. 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,"
"feels," "expects," "may," "will," "projects," "should," "seeks,"
"plans," "schedules 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 the
risk factors described in Point’s quarterly
report on Form 10-Q, filed with the Securities and Exchange Commission
on November 9, 2006, and from time to time in Point’s
other reports filed with the Securities and Exchange Commission.
POINT THERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Period from
Three months ended
September 30,
Nine months ended
September 30,
September 3, 1996
(date of inception)
through Sept. 30,
2006
2005
2006
2005
2006
REVENUES
License revenue
$ -
$ -
$ -
$ -
$ 5,115,041
Sponsored research revenue
220,407
-
359,202
-
2,920,407
Total revenues
220,407
-
359,202
-
8,035,448
OPERATING EXPENSES
Research and development
6,730,726
5,636,920
18,984,026
13,250,507
69,453,684
General and administrative
1,555,968
1,242,141
5,286,920
3,913,080
26,524,727
Total operating expenses
8,286,694
6,879,061
24,270,946
17,163,587
95,978,411
Net loss from operations
(8,066,287)
(6,879,061)
(23,911,744)
(17,163,587)
(87,942,963)
OTHER INCOME
Interest income, net
240,724
163,172
883,624
389,074
2,546,464
Net loss
$(7,825,563)
$(6,715,889)
$ (23,028,120)
$ (16,774,513)
$ (85,396,499)
Basic and diluted net loss per common share
$ (0.24)
$ (0.29)
$ (0.70)
$ (0.77)
-
Basic and diluted weighted average common shares outstanding
32,764,059
23,456,469
32,760,862
21,798,934
-
POINT THERAPEUTICS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
September 30,
2006
December 31,
2005
ASSETS
Cash, cash equivalents and restricted cash
$ 16,078,321
$ 37,634,230
Property and equipment, net
276,476
344,432
Other assets
2,304,242
2,421,937
Total assets
$ 18,659,039
$ 40,400,599
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
$ 4,842,991
$ 5,954,544
Other liabilities
36,601
47,087
Total stockholders' equity
13,779,447
34,398,968
Total liabilities and stockholders' equity
$ 18,659,039
$ 40,400,599
Point Therapeutics, Inc. (NASDAQ: POTP) today presented a
quarterly update on the Company's progress and reported financial
results for the fiscal quarter and nine months ended September 30,
2006.
Point furthered and/or completed several key initiatives:
-- Continued enrollment into the Company's two randomized Phase 3
double blind placebo-controlled trials of talabostat in
patients with metastatic non-small cell lung cancer (NSCLC)
who have previously failed platinum-based therapies. The first
Phase 3 trial evaluates docetaxel (Taxotere(R);
Sanofi-Aventis) with and without talabostat. The second Phase
3 trial evaluates pemetrexed (Alimta(R); Eli Lilly) with and
without talabostat. Both trials continue to accrue patients
and results from each trial are expected by the end of 2007.
In addition, the Company is currently recruiting study sites
in Canada.
-- Undertook cost reduction measures to prioritize the use of
capital resources to complete the Company's two Phase 3 NSCLC
clinical trials. These measures are projected to reduce the
Company's FY 2007 operating expenses by approximately $7.0
million, or 20%, from the projected operating expenses for FY
2006. Cost reduction measures include deferring the
preclinical development of the Company's type 2 diabetes
candidate, PT-630, focusing the Company's preclinical research
efforts to primarily support the clinical development of
talabostat and continuing tight control over discretionary
spending. Along with these measures, the Company has reduced
its workforce by approximately 15%, primarily in the internal
preclinical research group. With these measures in place, the
Company currently forecasts that the quarterly cash spend for
FY 2007 will be approximately $6.0 million. The Company
estimates that the total charges for the cost reduction plan
will be approximately $330,000.
-- Presented new preclinical data at two scientific meetings in
the last quarter. At annual meeting of the International
Society for Biological Therapy of Cancer Development (iSBTC)
in Los Angeles, CA in October, a study of talabostat conducted
in the laboratory of Dr. Lee J. Helman, in the Pediatric
Oncology Branch of the National Institutes of Health, was
presented. This study demonstrated in an osteosarcoma model
that mice treated with talabostat had a four-fold decrease in
the number of primary tumors compared to saline treatment,
and, in a separate experiment in the study, that mice treated
with talabostat had a 20-fold decrease in the number of gross
metastatic lung nodules compared to saline treatment. At the
American Association for Cancer Research Annual Meeting in
September, a study of talabostat conducted in the laboratory
of Dr. Charles Dinarello, a Professor of Medicine at the
University of Colorado School of Medicine, was presented that
highlighted talabostat's ability to stimulate key cytokines in
whole blood cultures from healthy humans, particularly IL-1
alpha, which is known to play an important role in
immunostimulation.
"The Company continues to make progress with our Phase 3 non-small
cell lung cancer clinical trials. In our ongoing efforts to further
talabostat's clinical development, particularly our Phase 3 program,
it became necessary for Point to undertake measures to reduce our
costs," said Don Kiepert, President and CEO. "These decisions are
always extremely difficult to make, but we believe that it is in the
best interest of the company for long-term success. We feel strongly
about the market potential of talabostat and, therefore, it is
extremely important to focus our current resources on advancing our
clinical programs. We greatly appreciate the contributions that each
departing employee has made to the Company, and we wish them great
success in the future," added Kiepert.
Point reported a net loss of $7,826,000 or $0.24 per basic and
diluted share in the third quarter of 2006, compared with a net loss
of $6,716,000, or $0.29 per basic and diluted share, in the third
quarter of 2005. For the first nine months of 2006, Point reported a
net loss of $23,028,000 or $0.70 per share, compared with a net loss
of $16,775,000 or $0.77 per share for the first nine months of 2005.
Research and development expenses increased to $6,731,000 in the
third quarter of 2006 from $5,637,000 in the third quarter of 2005.
The increase in research and development costs for the quarter
resulted primarily from external costs and new hires associated with
the Company's two Phase 3 NSCLC studies. In addition, non-cash
stock-based compensation for employee options in accordance with SFAS
No. 123R contributed to the increase.
General and administrative expenses increased to $1,556,000 in the
third quarter of 2006 from $1,242,000 in the third quarter of 2005.
The increase in general and administrative expenses for the quarter
resulted primarily from non-cash compensation for employee and
director stock options in accordance with SFAS No. 123R and increased
investor relations and business development consulting costs.
Point's cash and investment balance as of September 30, 2006 was
$16,078,000. Interest income was $241,000 in the third quarter of
2006, compared to $163,000 in the third quarter of 2005. The increase
in interest income resulted from higher interest rates.
A conference call is schedule for today, November 9, at 4:30 PM
EST. A re-broadcast of the conference call will be available until
November 16, 2006.
Conference call information:
U.S. & Canada toll-free dial in #: 800-591-6944
International dial in #: 617-614-4910
Participant code: 66385651
Replay toll-free dial in #: 888-286-8010
Replay international dial in #: 617-801-6888
Replay code: 78019990
About Point Therapeutics, Inc.:
Point is a Boston-based biopharmaceutical company which is
currently studying its lead product candidate, talabostat, in two
Phase 3 double blind placebo-controlled trials in non-small cell lung
cancer and in a Phase 2 trial in combination with gemcitabine in
metastatic pancreatic cancer. Point has also studied talabostat in
several Phase 2 trials, including as a single-agent in metastatic
melanoma, in combination with cisplatin in metastatic melanoma and in
combination with rituximab in advanced chronic lymphocytic leukemia.
Certain statements contained herein are not strictly historical
and are "forward looking" statements as defined in the Private
Securities Litigation Reform Act of 1995. These statements include,
without limitation, statements with respect to the company's clinical
development programs, the timing of initiation and completion of its
clinical trials, and the implementation of cost reduction plans,
including estimates related to the expense and future costs savings
associated with such plans. 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,"
"feels," "expects," "may," "will," "projects," "should," "seeks,"
"plans," "schedules 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 the risk factors described in Point's quarterly report on
Form 10-Q, filed with the Securities and Exchange Commission on
November 9, 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)
Three months ended Nine months ended
September 30, September 30,
2006 2005 2006 2005
------------ ------------ ------------- -------------
REVENUES
License revenue $- $- $- $-
Sponsored
research
revenue 220,407 - 359,202 -
------------ ------------ ------------- -------------
Total
revenues 220,407 - 359,202 -
------------ ------------ ------------- -------------
OPERATING
EXPENSES
Research and
development 6,730,726 5,636,920 18,984,026 13,250,507
General and
administrative 1,555,968 1,242,141 5,286,920 3,913,080
------------ ------------ ------------- -------------
Total
operating
expenses 8,286,694 6,879,061 24,270,946 17,163,587
------------ ------------ ------------- -------------
Net loss from
operations (8,066,287) (6,879,061) (23,911,744) (17,163,587)
OTHER INCOME
Interest income,
net 240,724 163,172 883,624 389,074
------------ ------------ ------------- -------------
Net loss $(7,825,563) $(6,715,889) $(23,028,120) $(16,774,513)
============ ============ ============= =============
Basic and
diluted net
loss per common
share $(0.24) $(0.29) $(0.70) $(0.77)
============ ============ ============= =============
Basic and
diluted
weighted
average common
shares
outstanding 32,764,059 23,456,469 32,760,862 21,798,934
============ ============ ============= =============
Period from
September 3,
1996
(date of
inception)
through Sept.
30,
2006
-------------
REVENUES
License revenue $5,115,041
Sponsored research revenue 2,920,407
-------------
Total revenues 8,035,448
-------------
OPERATING EXPENSES
Research and development 69,453,684
General and administrative 26,524,727
-------------
Total operating expenses 95,978,411
-------------
Net loss from operations (87,942,963)
OTHER INCOME
Interest income, net 2,546,464
-------------
Net loss $(85,396,499)
=============
Basic and diluted net loss per common share -
Basic and diluted weighted average common shares
outstanding -
*T
-0-
*T
POINT THERAPEUTICS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
September December 31,
30, 2005
2006
------------ ------------
ASSETS
Cash, cash equivalents and restricted cash $16,078,321 $37,634,230
Property and equipment, net 276,476 344,432
Other assets 2,304,242 2,421,937
------------ ------------
Total assets $18,659,039 $40,400,599
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $4,842,991 $5,954,544
Other liabilities 36,601 47,087
Total stockholders' equity 13,779,447 34,398,968
------------ ------------
Total liabilities and stockholders' equity $18,659,039 $40,400,599
============ ============
*T