Point Therapeutics, Inc. (NASDAQ: POTP) today reported financial
results for the fiscal quarter and nine months ended September 30,
2005. In the third quarter of 2005, Point reported a net loss of
$6,716,000 or $0.29 per share, compared with a net loss of
$4,294,000, or $0.24 per share, in the third quarter of 2004. For
the first nine months of 2005, Point reported a net loss of
$16,775,000 or $0.77 per share compared with a net loss of
$10,437,000 or $0.61 per share for the first nine months of 2004.
In the second half of 2005, Point achieved several important
milestones: -- Initiated a Phase 3 clinical program in metastatic
non-small cell lung cancer (NSCLC). This Phase 3 program was
initiated based upon the company achieving targeted Phase 2
endpoints and a successful End-of-Phase 2 meeting with the Food and
Drug Administration. The Phase 3 program is designed to further
evaluate the company's lead compound, talabostat, in patients with
Stage IIIB/IV NSCLC after failure of a platinum-based chemotherapy.
The program will consist of two randomized, double-blind,
placebo-controlled trials in up to 800 patients at approximately
100 sites in North America. The first 400-patient trial will
evaluate talabostat in combination with docetaxel versus docetaxel
with placebo. The second 400-patient trial will evaluate talabostat
in combination with pemetrexed versus pemetrexed with placebo.
Docetaxel and pemetrexed are the current standards of care in this
advanced patient population. -- Successfully completed the first
stage of the company's single-arm Phase 2 talabostat study in
advanced chronic lymphocytic leukemia (CLL) trial in combination
with rituximab. A 20% response rate was demonstrated in the first
20 evaluable patients, which was the targeted response rate needed
to continue the study to completion. The company anticipates
completing the second stage of the study in the first quarter of
2006. -- Received a $600,000 two-year Orphan Products Development
Grant from the Food and Drug Administration to fund its Phase 2
study of talabostat in combination with rituximab in patients with
advanced CLL. "In October, Point reached a major milestone in the
company's history when we initiated a Phase 3 program in non-small
cell lung cancer. Initial Phase 2 results showed that five of 36
patients had at least a 50% reduction in their tumor size--of which
two had a complete response, defined as a complete disappearance of
their tumor. In addition, median progression free survival was 4.0
months compared to the historically reported median of 2.9 months
for docetaxel alone," said Don Kiepert, President and CEO of Point
Therapeutics, Inc. "The company recently reported that further
analysis of all patients enrolled in the trial showed an increase
in median progression free survival over 4.0 months and that both
complete responders remain complete responders. We look forward to
presenting updated results in detail during a poster presentation
at the AACR-NCI-EORTC International Conference on Molecular Targets
and Cancer Therapeutics on Wednesday, November 16, 2005," added
Kiepert. "We were also encouraged by the interim results we saw in
our Phase 2 study in advanced CLL given that this is the first
Phase 2 study where we have combined talabostat with a monoclonal
antibody. We currently expect to have results on this study by the
end of the first quarter of 2006. I'm pleased to note that we were
one of the few corporate programs to receive an Orphan Products
Development Grant from the FDA for our CLL clinical program,"
concluded Kiepert. Research and development expenses increased to
$5,637,000 in the third quarter of 2005, from $3,398,000 in the
third quarter of 2005. The increase in research and development
costs resulted primarily from increased clinical and related
manufacturing costs relating to the company's five ongoing Phase 2
clinical trials and start-up costs for the company's Phase 3
clinical trial. General and administrative expenses increased to
$1,242,000 in the third quarter of 2005 from $942,000 in the third
quarter of 2004. The increase in general and administrative
expenses resulted primarily from costs for four new hires and
increased facility costs relating to the company's new office
space. Point's cash and investment balance as of September 30, 2005
was $18,875,000. 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 placement of approximately $15,000,000. In
addition, Point has received approximately $4,226,000 in proceeds
from the exercise of warrants and stock options for the first nine
months of 2005 offset by cash used in operations and for the
purchase of equipment of approximately $14,602,000. Interest income
was $163,000 in the third quarter of 2005 compared to $47,000 in
the third quarter of 2004. About Point Therapeutics, Inc.: Point is
a Boston-based biopharmaceutical company developing a family 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 a Phase 3 trial in NSCLC.
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 with respect to the company's
clinical development programs and the timing of initiation and
completion of its clinical trials. 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," "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 the risk factors described in Point's quarterly report on
Form 10-Q for the quarter ended June 30, 2005 and from time to time
in Point's periodic and 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,
2005 2004 2005 2004 ------------ ------------ -------------
------------- REVENUES License revenue $- $- $- $- Sponsored
research revenue - - - - ------------ ------------ -------------
------------- Total revenues - - - - ------------ ------------
------------- ------------- OPERATING EXPENSES Research and
development 5,636,920 3,398,493 13,250,507 7,628,886 General and
administrative 1,242,141 941,920 3,913,080 2,906,753 ------------
------------ ------------- ------------- Total operating expenses
6,879,061 4,340,413 17,163,587 10,535,639 ------------ ------------
------------- ------------- Net loss from operations (6,879,061)
(4,340,413) (17,163,587) (10,535,639) ------------ ------------
------------- ------------- Interest income 163,172 46,530 389,074
98,919 Interest expense - - - - ------------ ------------
------------- ------------- Net loss $(6,715,889) $(4,293,883)
$(16,774,513) $(10,436,720) ============ ============ =============
============= Basic and diluted net loss per common share $(0.29)
$(0.24) $(0.77) $(0.61) ============ ============ =============
============= Basis and diluted weighted average common shares
outstanding 23,456,469 18,254,331 21,798,934 17,207,162
============ ============ ============= ============= Period from
September 3, 1996 (date of inception) through Sept. 30, 2005
-------------------------- REVENUES License revenue $5,115,041
Sponsored research revenue 2,400,000 --------------------------
Total revenues 7,515,041 -------------------------- OPERATING
EXPENSES Research and development 45,473,902 General and
administrative 19,955,856 -------------------------- Total
operating expenses 65,429,758 -------------------------- Net loss
from operations (57,914,717) -------------------------- Interest
income 1,528,426 Interest expense (82,652)
-------------------------- Net loss $(56,468,943)
========================== Basic and diluted net loss per common
share Basis and diluted weighted average common shares outstanding
POINT THERAPEUTICS, INC. (A Development Stage Company) CONDENSED
CONSOLIDATED BALANCE SHEETS (UNAUDITED) September 30, December 31,
2005 2004 -------------- -------------- ASSETS Cash, cash
equivalents and restricted cash $18,875,116 $13,991,994 Property
and equipment, net 362,895 205,323 Other assets 545,095 298,758
-------------- -------------- Total assets $19,783,106 $14,496,075
============== ============== LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $5,013,976 $2,397,814 Other liabilities 49,503
47,604 Total stockholders' equity 14,719,627 12,050,657
-------------- -------------- Total liabilities and stockholders'
equity $19,783,106 $14,496,075 ============== ============== *T
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