Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ: POTP) today reported
financial results for the fourth quarter and fiscal year ended
December 31, 2005.
Point reported a net loss of $5,899,000 or $0.22 per share,
compared with a net loss of $4,721,000, or $0.26 per share, in the
fourth quarter of 2004. For fiscal year 2005, Point reported a net
loss of $22,674,000 or $0.98 per share compared with a net loss of
$15,158,000 or $0.87 per share for fiscal year 2004. Revenues of
$161,000 were recorded in the fourth quarter of 2005 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 (CLL).
"We made significant clinical and corporate progress in FY 2005
especially, concerning the development of talabostat, our lead product
candidate," said Don Kiepert, CEO and Chairman of Point. "Thus far,
talabostat has demonstrated biological activity in four phase 2
studies, and we are now focused on executing two phase 3 trials for
metastatic non-small cell lung cancer (NSCLC). Additionally we
continue to develop the Company's dipeptidyl peptidase programs which
include the advancement of our type 2 diabetes candidate, PT-630, into
late stage pre-clinical development. We have also made significant
progress in further elucidating talabostat's novel dual mechanism of
action. On April 25, 2006, we will be hosting an R & D day in New York
City to present in detail talabostat's novel mechanism," concluded
Kiepert.
Research and development expenses increased to $4,996,000 in the
fourth quarter of 2005 from $3,695,000 in the fourth quarter of 2004.
Research and development expenses increased to $18,246,000 in fiscal
year 2005, from $11,324,000 in fiscal year 2004. The increase in
research and development costs for both the quarter and fiscal year
resulted primarily from clinical and manufacturing costs relating to
the Company's five ongoing Phase 2 clinical trials and the initiation
of the first of two Phase 3 non-small cell lung cancer clinical
trials.
General and administrative expenses increased to $1,282,000 in the
fourth quarter of 2005 from $1,084,000 in the fourth quarter of 2004.
General and administrative expenses increased to $5,195,000 in fiscal
year 2005 from $3,991,000 in fiscal year 2004. The increase in general
and administrative expenses for both the quarter and fiscal year
resulted primarily from costs for new hires and other expenses to
support the Company's programs.
Point's cash and investment balance as of December 31, 2005 was
$37,634,000. In November/December 2005, Point raised $27,773,000 in
gross proceeds relating to the sale of 9,257,500 shares of common
stock in a public offering. Offsetting these proceeds were costs
totaling approximately $2,257,000, relating to the sale of the shares,
resulting in net proceeds from the placement of approximately
$25,516,000. In March 2005, Point raised $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 $1,394,000, relating to the offering
of the shares, resulting in net proceeds from the placement of
approximately $15,031,000. In addition, Point received approximately
$4,226,000 in proceeds from the exercise of warrants and stock options
in fiscal year 2005. These proceeds were offset by cash used in
operations of approximately $21,108,000 and capital equipment
purchases of $249,000. Interest income was $217,000 in the fourth
quarter of 2005 compared to $58,000 in the fourth quarter of 2004.
Interest income was $606,000 in fiscal year 2005 compared to $157,000
in fiscal year 2004. The increase in interest income was due to higher
cash balances and interest rates earned in both the fourth quarter and
year.
In 2005, Point achieved a number of critical milestones. The most
important was the initiation of the Company's Phase 3 talabostat
clinical program in NSCLC patients. The first of two studies in this
program was launched in October 2005; a 400 patient trial testing the
combination of talabostat and docetaxel versus docetaxel with placebo.
Other important milestones for 2005 that the Company has
previously reported on include:
-- Successful completion of the first stage of the Company's
Phase 2 talabostat study in advanced CLL. To date, 7 out
of 33 evaluable patients (21.2%) have demonstrated a
positive response which exceeded the Company's targeted
response rate of 20%. Trial results are expected in the
second half of 2006.
-- Received a $600,000 two-year Orphan Products Development
Grant from the Food and Drug Administration to support the
Company's Phase 2 CLL study.
-- Demonstrated biological activity in both the single agent
talabostat and talabostat in combination with cisplatin
Phase 2 studies in metastatic melanoma. In the single
agent study, 2 out of 31 evaluable patients in a very
advanced patient population demonstrated a tumor response,
including one patient who had a complete response. In the
combination with cisplatin study, 5 out of 42 patients
(11.9%) demonstrated a tumor response. The median
progression free survival (PFS) in the combination study
was 2.8 months, which is approximately double the PFS
compared to the current standard of care therapy.
-- Initiated a 60 patient Phase 2 clinical trial of
talabostat in combination with gemcitabine for the
treatment of metastatic pancreatic cancer. Six month
survival is the primary endpoint of the study. Interim
results are expected from this trial in the second half of
2006.
A conference call is schedule for today, March 14 at 4:30 PM EST.
U.S. & Canada toll-free dial in #: 866-510-0710
International dial in #: 617-597-5378
Participant code: 25591960
Replay toll-free dial in #: 888-286-8010
Replay international dial in #: 617-801-6888
Replay code: 89953608
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
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 CLL, 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
September 30, 2005 and from time to time in Point's periodic and 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)
Three months ended Twelve months ended
December 31, December 31,
2005 2004 2005 2004
------------ ------------ ------------- -------------
REVENUES
License
revenue $- $- $- $-
Sponsored
research
revenue 161,205 - 161,205 -
------------ ------------ ------------- -------------
Total
revenues 161,205 - 161,205 -
------------ ------------ ------------- -------------
OPERATING
EXPENSES
Research and
development 4,995,756 3,695,359 18,246,263 11,324,245
General and
administra-
tive 1,281,951 1,083,910 5,195,031 3,990,663
------------ ------------ ------------- -------------
Total
operating
expenses 6,277,707 4,779,269 23,441,294 15,314,908
------------ ------------ ------------- -------------
Net loss from
operations (6,116,502) (4,779,269) (23,280,089) (15,314,908)
------------ ------------ ------------- -------------
Interest
income 217,066 57,921 606,140 156,840
Interest
expense - - - -
------------ ------------ ------------- -------------
Net loss $(5,899,436) $(4,721,348) $(22,673,949) $(15,158,068)
============ ============ ============= =============
Basic and
diluted net
loss per
common share $(0.22) $(0.26) $(0.98) $(0.87)
============ ============ ============= =============
Basic and
diluted
weighted
average
common shares
outstanding 26,863,309 18,257,836 23,075,434 17,471,266
============ ============ ============= =============
POINT THERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Period from
September 3,
1996
(date of
inception)
through
Dec. 31, 2005
-------------
REVENUES
License revenue $5,115,041
Sponsored research revenue 2,561,205
-------------
Total revenues 7,676,246
-------------
OPERATING EXPENSES
Research and development 50,469,658
General and administrative 21,237,807
-------------
Total operating expenses 71,707,465
-------------
Net loss from operations (64,031,219)
-------------
Interest income 1,745,492
Interest expense (82,652)
-------------
Net loss $(62,368,379)
=============
POINT THERAPEUTICS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
December 31, December 31,
2005 2004
------------ ------------
ASSETS
Cash, cash equivalents and restricted cash $37,634,230 $13,991,994
Property and equipment, net 344,432 205,323
Other assets 2,421,937 298,758
------------ ------------
Total assets $40,400,599 $14,496,075
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $5,954,544 $2,397,814
Other liabilities 47,087 47,604
Total stockholders' equity 34,398,968 12,050,657
------------ ------------
Total liabilities and stockholders' equity $40,400,599 $14,496,075
============ ============
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