Point Therapeutics (MM) (NASDAQ:POTP)
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Point Therapeutics, Inc. (NASDAQ: POTP) today reported
financial results for the fiscal quarter and six months ended June 30,
2005.
In the second quarter of 2005, Point reported a net loss of
$5,143,000 or $0.23 per share, compared with a net loss of $3,008,000,
or $0.17 per share, in the second quarter of 2004. For the first six
months of 2005, Point reported a net loss of $10,059,000 or $0.48 per
share compared with a net loss of $6,143,000 or $0.37 per share for
the first six months of 2004.
During the second quarter of 2005, Point achieved several
important milestones:
-- Announced positive results in the company's 41 patient Phase 2
metastatic non-small cell lung cancer (NSCLC) study of
talabostat in combination with docetaxel. In the first 36
evaluable patients, five patients demonstrated a significant
tumor response. Most importantly, two of the patients had a
complete (100%) tumor response. Based on these results, which
were presented in May at a poster session at the American
Society of Clinical Oncology Annual Meeting, the company is
preparing to begin a Phase 3 trial in NSCLC in the second half
of 2005.
-- Announced positive interim results in the company's Phase 2
metastatic melanoma program. In the 30 patient single-agent
talabostat trial, two patients out of the first 18 evaluable
patients had a significant tumor response, with one patient
experiencing a complete (100%) tumor response. In the 54
patient combination study of talabostat with cisplatin, 2
patients out of the first 15 evaluable patients had a partial
tumor response.
-- Held the company's first Research and Development Day in New
York City. Speakers included Dr. Casey Cunningham, an
investigator in Point's Phase 2 NSCLC study at Mary Crowley
Medical Research Center in Dallas, TX and Dr. Khuda Dad Khan,
an investigator in Point's Phase 2 metastatic melanoma trial
at Indiana Oncology and Hematology Associates. The Web cast
for this event is archived on the company's Web site,
www.pther.com, in the Investor Relations section under
"Presentations."
-- Initiated a 60 patient Phase 2 clinical trial of talabostat in
combination with gemcitabine for the treatment of metastatic
pancreatic cancer.
"In the second quarter, Point Therapeutics made significant
progress in meeting our key clinical objectives," said Don Kiepert,
President and CEO of Point Therapeutics, Inc. "We achieved the desired
results in our Phase 2 non-small cell lung cancer trial and we intend
to launch a Phase 3 program in the second half of this year. Interim
results in our two melanoma trials were also promising. Most
importantly, we were pleased to see a complete responder in the single
agent trial which provides further support of talabostat's biological
activity. Additionally, we launched our fifth Phase 2 trial of
talabostat in combination with gemcitabine in metastatic pancreatic
cancer. I am very pleased with the progress Point has made to date,
especially in achieving the key clinical milestones of the last
quarter. I feel strongly that these accomplishments position Point
well for the second half of the year."
Research and development expenses increased to $4,061,000 in the
second quarter of 2005, from $2,205,000 in the second 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. General and
administrative expenses increased to $1,227,000 in the second quarter
of 2005 from $837,000 in the second quarter of 2004. The increase in
general and administrative expenses resulted primarily from costs for
three new hires and increased patent activity.
Point's cash and investment balance as of June 30, 2005 was
$24,008,000. 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 private
placement of approximately $15,000,000. In addition, Point has
received approximately $3,848,000 in proceeds from the exercise of
warrants and stock options for the first six months of 2005 offset by
cash used in operations and for the purchase of equipment of
approximately $9,158,000. Interest income was $145,000 in the second
quarter of 2005 compared to $34,000 in the second 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. Its lead product candidate,
talabostat (PT-100), is a small molecule drug in Phase 2 clinical
trials. Talabostat is orally-active and, through a novel mechanism of
action, has the potential to inhibit the growth of malignant tumors
and to support the reconstitution of the hematopoietic system. In
2004, Point initiated four Phase 2 clinical trials of talabostat. The
trials are studying talabostat in combination with docetaxel in
metastatic non-small cell lung cancer, talabostat as a single agent in
metastatic melanoma, talabostat in combination with cisplatin in
metastatic melanoma, and talabostat in combination with rituximab in
advanced chronic lymphocytic leukemia. In June of 2005, Point
announced the initiation of a fifth Phase 2 clinical trial studying
talabostat 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 on the prospects for our drug development activities and
results of operations based on our current expectations, such as
statements regarding certain milestones with respect to our clinical
program and our product candidates. 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, but not limited to, the ability of Point to (i)
successfully develop and manufacture products, (ii) obtain external
funding to finance the operations, (iii) obtain the necessary
regulatory approvals, and (iv) obtain and enforce intellectual
property rights, as well as the risk factors described in Point's
Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission on May 10, 2005 and from time to time in Point's 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 Six months ended
June 30, June 30,
2005 2004 2005 2004
----------- ------------- ------------- ------------
REVENUES
License
revenue $- $- $- $-
Sponsored
research
revenue - - - -
----------- ------------- ------------- ------------
Total
revenues - - - -
----------- ------------- ------------- ------------
OPERATING
EXPENSES
Research and
development 4,060,603 2,204,776 7,613,587 4,230,393
General and
administrative 1,227,307 837,152 2,670,939 1,964,833
----------- ------------- ------------- ------------
Total
operating
expenses 5,287,910 3,041,928 10,284,526 6,195,226
----------- ------------- ------------- ------------
Net loss from
operations (5,287,910) (3,041,928) (10,284,526) (6,195,226)
----------- ------------- ------------- ------------
Interest
income 144,631 33,603 225,902 52,389
Interest
expense - - - -
----------- ------------- ------------- ------------
Net loss $(5,143,279) $(3,008,325) $(10,058,624) $(6,142,837)
=========== ============= ============= ============
Basic and
diluted net
loss per
common
share $(0.23) $(0.17) $(0.48) $(0.37)
============ ============= ============= ============
Basis and
diluted
weighted
average
common
shares
outstanding 22,456,565 18,186,742 20,956,429 16,677,824
============ ============= ============= ============
Period from
September 3, 1996
(date of inception)
through June 30, 2005
-------------
REVENUES
License
revenue $5,115,041
Sponsored
research
revenue 2,400,000
-------------
Total
revenues 7,515,041
-------------
OPERATING
EXPENSES
Research and
development 39,836,982
General and
administrative 18,713,715
-------------
Total
operating
expenses 58,550,697
-------------
Net loss from
operations (51,035,656)
-------------
Interest
income 1,365,254
Interest
expense (82,652)
-------------
Net loss $(49,753,054)
=============
POINT THERAPEUTICS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
June 30, December 31,
2005 2004
------------ ------------
ASSETS
Cash, cash equivalents and restricted cash $24,008,455 $13,991,994
Property and equipment, net 221,459 205,323
Other assets 425,280 298,758
------------ ------------
Total assets $24,655,194 $14,496,075
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $3,597,178 $2,397,814
Other liabilities 42,364 47,604
Total stockholders' equity 21,015,652 12,050,657
------------ ------------
Total liabilities and stockholders' equity $24,655,194 $14,496,075
============ ============
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