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
Point Therapeutics (MM) (NASDAQ:POTP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Point Therapeutics (MM) (NASDAQ:POTP)
Historical Stock Chart
From Jul 2023 to Jul 2024