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