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. -0- *T
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 ============ ============ *T
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