Point Therapeutics, Inc. (NASDAQ: POTP) today presented a quarterly
update on the Company's progress and reported financial results for
the fiscal quarter and six months ended June 30, 2006. In the
second quarter of 2006, Point achieved several important
milestones: -- Continued enrollment into the Company's two
randomized Phase 3 double blind placebo-controlled trials of
talabostat in patients with metastatic non-small cell lung cancer
(NSCLC) who have previously failed platinum based therapies. Each
trial will enroll approximately four-hundred patients. The first
trial is evaluating docetaxel (Taxotere(R); Sanofi-Aventis) with
and without talabostat. The second randomized Phase 3 trial is
studying pemetrexed (Alimta(R); Eli Lilly) with and without
talabostat. Both trials continue to accrue patients. -- Received
Fast Track Designation for talabostat for the treatment of Stage
IIIB/IV NSCLC patients who have failed prior platinum-based
chemotherapy from the U.S. Food and Drug Administration (FDA).
Under the FDA Modernization Act of 1997, the Fast Track program is
designed to facilitate the development and expedite the review of a
new drug that is intended for the treatment of a serious or a
life-threatening condition and demonstrates the potential of a drug
candidate to address unmet medical needs for such a condition. Fast
track designation relates to the processing of the application and
does not change the approval standards nor does it imply anything
regarding whether the agency ultimately will approve the drug for
marketing. Under the FDA Guidance, drugs that are granted Fast
Track status typically represent a significant improvement in the
safety or effectiveness over existing therapies. -- Presented
updated data evaluating talabostat's anti-tumor activity in Phase 2
clinical trials in patients with advanced chronic lymphocytic
leukemia (CLL) in combination with rituximab and metastatic
melanoma in combination with cisplatin at the 42nd American Society
of Clinical Oncology (ASCO) Annual Meeting in Atlanta, Georgia. In
both studies, additional responders were reported. The Company
believes these studies continue to demonstrate clear signs of
talabostat's biological activity in patients with advanced disease
who have failed multiple therapies and for whom there are few or no
approved treatments. In addition, clinical investigators from Fox
Chase Cancer Center and the National Cancer Institute presented
investigator sponsored studies of talabostat in salvage metastatic
colorectal cancer patients and a murine osteosarcoma model,
respectively, at ASCO. -- Presented preclinical posters on the
Company's lead type 2 diabetes compound, PT-630, at the American
Diabetes Association 66th Annual Scientific Sessions and the
Endocrine Society Annual Meeting. PT-630 is an inhibitor of DPP-4,
which is a widely recognized target for the treatment of type 2
diabetes. Detailed information on these and other Point studies,
including copies of scientific poster presentations, are available
on the company's Web site at www.pther.com. "We continued to make
strides in our clinical development program this quarter, as
evidenced by our Fast Track Designation in June and our multiple
presentations at ASCO," said Don Kiepert, President and CEO of
Point Therapeutics, Inc. "We were pleased that two of our
collaborators, Fox Chase Cancer Center and the National Cancer
Institute, also presented data at ASCO this year. We continue to
work with a number of collaborators on exploratory studies to
investigate talabostat in additional indications and in combination
with different anti-cancer agents. To date, in the clinical
setting, we have studied talabostat in more than 500 patients in
seven different indications with 6 anti-cancer agents," stated
Kiepert. Point reported a net loss of $7,346,000 or $0.22 per basic
and diluted share in the second quarter of 2006, compared with a
net loss of $5,143,000, or $0.23 per basic and diluted share, in
the second quarter of 2005. For the first six months of 2006, Point
reported a net loss of $15,203,000 or $0.46 per share, compared
with a net loss of $10,059,000 or $0.48 per share for the first six
months of 2005. Research and development expenses increased to
$5,935,000 in the second quarter of 2006 from $4,061,000 in the
second quarter of 2005. The increase in research and development
costs for the quarter resulted primarily from external costs and
new hires associated with the Company's two Phase 3 NSCLC studies.
In addition, non-cash stock-based compensation for employee options
in accordance with SFAS No. 123R contributed to the increase.
General and administrative expenses increased to $1,713,000 in the
second quarter of 2006 from $1,227,000 in the second quarter of
2005. The increase in general and administrative expenses for the
quarter resulted primarily from non-cash compensation for employee
and director stock options in accordance with SFAS No. 123R and
increased investor relations and consulting costs. Point's cash and
investment balance as of June 30, 2006 was $23,123,000. Interest
income was $302,000 in the second quarter of 2006, compared to
$145,000 in the second quarter of 2005. The increase in interest
income resulted from higher interest rates. A conference call is
schedule for today, August 8, at 4:30 PM ET. A re-broadcast of the
conference call will be available until August 15, 2006. U.S. &
Canada toll-free dial in #: 866-202-3048 International dial in #:
617-213-8843 Participant code: 12632977 Replay toll-free dial in #:
888-286-8010 Replay international dial in #: 617-801-6888 Replay
code: 51903272 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 double blind
placebo-controlled trials in non-small cell lung cancer. 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. These statements
include, without limitation, 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,"
"projects," "should," "seeks," "plans," "schedules 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, filed
with the Securities and Exchange Commission on May 9, 2006, 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 June 30, 2006 2005 ------------
------------ REVENUES License revenue $- $- Sponsored research
revenue - - ------------ ------------ Total revenues - -
------------ ------------ OPERATING EXPENSES Research and
development 5,934,937 4,060,603 General and administrative
1,712,555 1,227,307 ------------ ------------ Total operating
expenses 7,647,492 5,287,910 ------------ ------------ Net loss
from operations (7,647,492) (5,287,910) OTHER INCOME Interest
income, net 301,548 144,631 ------------ ------------ Net loss
$(7,345,944) $(5,143,279) ============ ============ Basic and
diluted net loss per common share $(0.22) $(0.23) ============
============ Basis and diluted weighted average common shares
outstanding 32,763,564 22,456,565 ============ ============ Period
from Six months ended September 3, June 30, 1996 (date of
inception) through June 30, 2006 2005 2006 -------------
------------- ------------- REVENUES License revenue $- $-
$5,115,041 Sponsored research revenue 138,795 - 2,700,000
------------- ------------- ------------- Total revenues 138,795 -
7,815,041 ------------- ------------- ------------- OPERATING
EXPENSES Research and development 12,253,300 7,613,587 62,722,958
General and administrative 3,730,952 2,670,939 24,968,759
------------- ------------- ------------- Total operating expenses
15,984,252 10,284,526 87,691,717 ------------- -------------
------------- Net loss from operations (15,845,457) (10,284,526)
(79,876,676) OTHER INCOME Interest income, net 642,900 225,902
2,305,740 ------------- ------------- ------------- Net loss
$(15,202,557) $(10,058,624) $(77,570,936) =============
============= ============= Basic and diluted net loss per common
share $(0.46) $(0.48) ============= ============= Basis and diluted
weighted average common shares outstanding 32,759,246 20,956,429
============= ============= POINT THERAPEUTICS, INC. (A Development
Stage Company) CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
June 30, December 31, 2006 2005 ------------ ------------ ASSETS
Cash, cash equivalents and restricted cash $23,122,726 $37,634,230
Property and equipment, net 294,358 344,432 Other assets 2,444,688
2,421,937 ------------ ------------ Total assets $25,861,772
$40,400,599 ============ ============ LIABILITIES AND STOCKHOLDERS'
EQUITY Current liabilities $4,709,018 $5,954,544 Other liabilities
37,818 47,087 Total stockholders' equity 21,114,936 34,398,968
------------ ------------ Total liabilities and stockholders'
equity $25,861,772 $40,400,599 ============ ============ *T
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