Point Therapeutics (MM) (NASDAQ:POTP)
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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-
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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
============== ==============
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