LA JOLLA, Calif., Aug. 8 /PRNewswire-FirstCall/ -- TorreyPines
Therapeutics, Inc. (Nasdaq: TPTX) today announced that Neil Kurtz, M.D., is
resigning as President, Chief Executive Officer and a director of the company
effective as of August 31, 2008. Dr. Kurtz is leaving TorreyPines to assume
the role of President and Chief Executive Officer with a major healthcare
services company. TorreyPines also named his replacement with the appointment
of Evelyn Graham as acting Chief Executive Officer. Ms. Graham has been the
company's Chief Operating Officer since 2006.
"We thank Neil for his leadership and many contributions to TorreyPines
during his tenure as CEO," said Peter Davis, Ph.D., Chairman of the Board of
Directors of TorreyPines.
Dr. Davis continued, "We are proud to announce the appointment of Ev as
acting CEO. Her extensive drug development experience and detailed
understanding of the company make her the perfect fit to lead TorreyPines as
we continue to advance our programs through significant regulatory and
clinical milestones."
"I look forward to continuing to work with our current management team in
this new role to realize the full potential of our promising product
candidates," said Ms. Graham. "We are currently preparing for our end of
Phase II meeting with the FDA on September 29th during which we will discuss
our proposed Phase III migraine program for tezampanel. In addition, we are
continuing to advance NGX426, the oral version of tezampanel, having initiated
a Phase I clinical trial to evaluate its analgesic effect. We anticipate
announcing results from this Phase I trial by the end of the year, as well as
announcing results from an ongoing Phase II clinical trial of our lead
muscarinic agonist, NGX267, in xerostomia secondary to Sjogren's Syndrome."
Ms. Graham joined TorreyPines in 2004 as Vice President, Development. She
was then promoted to Vice President, Corporate Development in 2005 and Chief
Operating Officer in 2006. Prior to joining TorreyPines Ms. Graham was
Executive Director, Development Operations at Purdue Pharma from 2000 to 2003.
From 1998 to 2000, she was Senior Vice President of Business Development at
Ingenix Pharmaceutical Services, a division of UHG, and served as Vice
President of Clinical Operations at Worldwide Clinical Trials, prior to its
acquisition by UHG. Previously, Ms. Graham held positions in operations
management, healthcare utilization and organizational planning at Bayer
Corporation and Wyeth Pharmaceuticals (formerly Ayerst Laboratories). Ms.
Graham holds a B.A. in biology from the University of Delaware and an M.B.A.
from the University of Connecticut.
Second Quarter 2008 Financial Results
The company also reported today its financial results for the second
quarter ended June 30, 2008. For the three month period ended June 30, 2008
the company posted revenue of $1.2 million compared to revenue of $2.5 million
for the same period in 2007. Operating expenses for the quarter ended June
30, 2008 were $7.2 million, with $5.5 million attributable to research and
development. This compares to operating expenses of $8.5 million and research
and development expenses of $7.1 million for the same period last year. The
net loss for the quarter ended June 30, 2008 was $7.5 million compared to a
net loss of $5.2 million for the same period last year. Cash and cash
equivalents totaled $20.2 million at June 30, 2008.
Revenue for the six month period ended June 30, 2008 was $3.3 million
compared to revenue of $4.9 million for the same period in 2007. Operating
expenses for the six month period were $14.0 million, with $10.8 million
attributable to research and development. This compares to operating expenses
of $15.1 million and research and development expenses of $12.2 million for
the same six month period last year. The company reported a net loss for the
six months ended June 30, 2008 of $11.3 million compared to a net loss of $8.4
million for the same period last year.
Second Quarter 2008 Accomplishments:
-- Announced that the company will hold an end of Phase II meeting on
September 29, 2008 with the U.S. Food and Drug Administration to discuss the
tezampanel Phase III development plan for acute migraine.
-- Initiated a Phase I clinical trial to evaluate the analgesic effect of
NGX426, the oral prodrug of tezampanel. The study will evaluate the effect of
NGX426 on hyperalgesia, an abnormally increased pain state, and allodynia,
pain resulting from normally non-painful stimuli to the skin, induced by
intradermal injections of capsaicin. This study, if successful, will allow
the company to further benefit from of the versatility of NGX426.
-- Presented data from the tezampanel Phase IIb clinical trial in acute
migraine at the American Headache Society's Annual Scientific Meeting. The
data showed that in addition to meeting the primary endpoint of headache pain
relief at two hours, tezampanel demonstrated improvement on important
secondary endpoints including: sustained headache response, absence of nausea,
absence of phonophobia and absence of photophobia.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a biopharmaceutical company committed to
providing patients with better alternatives to existing therapies through the
research, development and commercialization of small molecule compounds. The
company's goal is to develop versatile product candidates, each capable of
treating a number of acute and chronic diseases and disorders such as
migraine, chronic pain, muscle spasticity and rigidity, xerostomia and
cognitive disorders. The company is currently developing four product
candidates: two ionotropic glutamate receptor antagonists and two muscarinic
receptor agonists. Further information is available at
http://www.torreypinestherapeutics.com.
This press release contains forward-looking statements or predictions.
Such forward-looking statements include, but are not limited to, statements
regarding the plans for holding an end of Phase II meeting with the FDA, the
potential for tezampanel and NGX426 as treatments for acute migraine and other
indications, the potential for NGX426 to be analgesic, the anticipated timing
of results for the NGX426 study in a model of capsaicin-induced pain, the
potential for NGX267 as a treatment for xerostomia secondary to Sjogren's
syndrome and the anticipated timing of results from the study of NGX267 as a
treatment for xerostomia secondary to Sjogren's syndrome. Such statements are
subject to numerous known and unknown risks, uncertainties and other factors,
which may cause TorreyPines' actual results to be materially different from
historical results or from any results expressed or implied by such
forward-looking statements, including whether any preclinical studies or
clinical trials, either ongoing or conducted in the future, will prove
successful, and if successful, whether the results can be replicated; whether
safety and efficacy profiles of any of the company's product candidates will
be established, or if established, will remain the same, be better or worse in
future clinical trials, if any; whether pre-clinical results will be
substantiated by ongoing or future clinical trials, if any, or whether any of
the company's product candidates will be able to improve the signs or symptoms
of their respective clinical indication; whether any of the company's product
candidates will support a filing for marketing approval, will be approved by
the regulatory authorities, or if approved, will prove competitive in the
market; or whether the necessary financing to support the company's product
development programs will be available. In particular there is no guarantee
that clinical trials of any of the company's product candidates will be
completed on schedule or that results of these clinical trials will be
reported within the anticipated timeframe, that tezampanel or NGX426 will
successfully treat migraine and/or other indications for which they are
developed, that the End of Phase II meeting will be held in the anticipated
time frame, that NGX267 will successfully treat xerostomia secondary to
Sjogren's syndrome or that TorreyPines will be able to complete the necessary
development work and receive regulatory approval for tezampanel, NGX426 or
NGX267. These and other risks which may cause results to differ are described
in greater detail in the "Risk Factors" section of TorreyPines' annual report
on Form 10-K for the year ended December 31, 2007 and TorreyPines other SEC
reports. The forward-looking statements are based on current information that
is likely to change and speak only as of the date hereof.
Company Contact: Media Contact:
Craig Johnson David Schull
TorreyPines Therapeutics, Inc. Russo Partners, LLC
858-623-5665, x158 212-845-4271
cjohnson@torreypinestherapeutics.comdavid.schull@russopartners.com
Investor Contact:
Rhonda Chiger
Rx Communications
917-322-2569
rchiger@RxIR.com
(Tables Follow)
TorreyPines Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
June 30, December 31,
2008 2007
(Unaudited)
Assets
Current assets
Cash and cash equivalents $20,185 $32,500
Prepaid expenses and other current assets 346 835
Total current assets 20,531 33,335
Long-term assets 4,434 5,317
Total assets $24,965 $38,652
Liabilities and stockholders' equity
Current liabilities $5,938 $9,036
Debt and other long-term liabilities 2,823 973
Deferred revenue 450 2,183
Total liabilities 9,211 12,192
Total stockholders' equity 15,754 26,460
Total liabilities and stockholders' equity $24,965 $38,652
TorreyPines Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2008 2007 2008 2007
Revenue
License and option
fees $450 $1,700 $1,733 $3,400
Research funding 762 763 1,525 1,525
Total revenue 1,212 2,463 3,258 4,925
Operating expenses:
Research and
development 5,491 7,052 10,751 12,229
General and
administrative 1,751 1,463 3,199 2,858
Total operating
expenses 7,242 8,515 13,950 15,087
Loss from operations (6,030) (6,052) (10,692) (10,162)
Other income (expense)
Interest income 113 587 330 1,195
Interest expense (110) (216) (257) (453)
Other income
(expense), net (1,423) 523 (724) 981
Total other income
(expense) (1,420) 894 (651) 1,723
Net loss $(7,450) $(5,158) $(11,343) $(8,439)
Basic and diluted
net loss per share $(0.47) $(0.33) $(0.72) $(0.54)
Weighted average
shares used in
the computation
of basic and
diluted net loss
per share 15,748,104 15,711,588 15,743,875 15,699,834
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