Axonyx (NASDAQ:AXYX)
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Axonyx Inc. (NASDAQ: AXYX) and TorreyPines Therapeutics,
Inc., a private company, today announced that they have entered into a
definitive merger agreement. The merger would create a NASDAQ listed
biopharmaceutical company that discovers and develops treatments for
central nervous system (CNS) disorders. The resulting company will be
named TorreyPines Therapeutics, Inc. and be headquartered in San
Diego, California.
Under terms of the agreement, unanimously approved by both boards
of directors, Axonyx would issue, and TorreyPines stockholders would
receive, in a tax-free transaction, shares of Axonyx common stock such
that TorreyPines stockholders would own approximately 58% of the
combined company and Axonyx stockholders would own approximately 42%.
These relative percentages will be adjusted if either party
out-licenses one or more product candidates prior to closing. In
addition, TorreyPines preferred shareholders will receive warrants to
purchase combined company shares that, if fully exercised at closing,
would give TorreyPines shareholders approximately 62% of the combined
company. The transaction is subject to Axonyx maintaining certain
minimum cash levels, as well as certain other customary conditions,
including obtaining approval of each company's stockholders. The
transaction is expected to close during the fourth quarter of this
year. Upon closing, the company is expected to trade on the NASDAQ
Stock Market for which the company has reserved the symbol "TPTX."
The combined company will have a deep, robust and diversified CNS
pipeline focused on novel therapeutics for neurological diseases and
disorders. At March 31, 2006, the pro forma combined company had more
than $80 million in cash. The combined company's initial focus will be
on migraine, chronic pain and Alzheimer's disease (AD). The pipeline
at closing will include eight product candidates, with two candidates
for pain and six for AD. The companies anticipate several key
milestones related to their product candidates during the next 12
months. Among these include the following:
-- TorreyPines' lead product candidate for chronic pain,
tezampanel, is expected to enter into a Phase IIb clinical
trial for the treatment of migraine.
-- TorreyPines expects to file an Investigational New Drug (IND)
application with the U.S. Food and Drug Administration (FDA)
and initiate a Phase I trial for NGX426, an oral prodrug of
tezampanel, and a follow-on compound for migraine and chronic
pain.
-- Axonyx will complete its ongoing Phase I trials with
Posiphen(TM) in development for the treatment of AD
progression.
-- Data will become available from TorreyPines' Phase I single
dose study evaluating the company's lead AD product candidate,
NGX267, a muscarinic or M1 receptor agonist, in healthy
elderly volunteers. In addition, the company anticipates
initiating a Phase I multiple dose trial with the compound.
-- Axonyx to begin a Phase I clinical trial with BNC, its highly
selective butyrylcholinesterase inhibitor for the treatment of
severe AD.
The combined pipeline also includes Phenserine, Axonyx's lead
compound for AD, which is in Phase III clinical development. The
combined company plans to make Phenserine available to third parties
for licensing.
"This merger will create a premier biopharmaceutical company with
development and discovery capabilities across the CNS spectrum," said
Neil Kurtz, M.D., President and Chief Executive Officer of
TorreyPines. "This joining of two exciting and complementary pipelines
under one roof, with substantial financial assets to support continued
efforts toward commercialization, should be a 'win-win' situation for
the shareholders of both companies. This transaction truly brings
together all of the necessary ingredients for a successful
biopharmaceutical company: a notable pipeline of multiple product
opportunities; proven clinical development and discovery capabilities
to fuel ongoing product development; and strong financial resources.
We plan to review all development opportunities with the goal of
prioritizing the best opportunities while maintaining a reasonable
burn rate."
"This transaction meets one of Axonyx's key strategic business
objectives: to grow and strengthen our company in the area of CNS,"
said Gosse B. Bruinsma, M.D., President and Chief Executive Officer of
Axonyx. "By combining with TorreyPines, our shareholders will benefit
from a stronger company that remains wholly dedicated to becoming a
leading biopharmaceutical company in the area of CNS. The merger with
TorreyPines brings with it a broad pipeline that currently has
multiple and complementary clinical programs underway in AD, as well
as programs in migraine and chronic pain. TorreyPines' management team
has significant drug development expertise and their experience and
infrastructure will, in my opinion, provide an excellent opportunity
to continue to move our product candidates toward potential approval."
Products in or nearing clinical development will include:
Tezampanel: TorreyPines' lead product candidate is a novel,
parenteral compound for the treatment of chronic pain. Tezampanel is
an AMPA/kainate (AK) receptor antagonist, offering a non-opioid,
non-vascular approach to the management of migraine and other chronic
pain states and represents a potentially promising alternative to
current treatments. Two Phase I trials and five Phase IIa trials have
been completed with tezampanel and TorreyPines plans to move forward
with a Phase IIb clinical trial for the treatment of migraine.
NGX426: TorreyPines' follow-on compound for chronic pain is an
oral prodrug of tezampanel. TorreyPines plans to file an IND for
NGX426 with the FDA and initiate a Phase I study. Both NGX426 and
tezampanel may effectively relieve migraine and chronic pain through a
novel mechanism that may not impart the side effects and risks
associated with currently available migraine and other pain
treatments.
NGX267: TorreyPines' lead AD product is a muscarinic or M1
receptor agonist. The M1 receptor plays an important role in memory
and cognitive processing. Its activation has also been linked to a
decrease in beta amyloid 1-42 (A beta 42) production, a peptide that
is involved in the creation of the amyloid plaques that are hallmarks
of AD. NGX267 has completed a Phase I single dose study in healthy
males and a second single dose study in healthy elderly volunteers.
TorreyPines plans to initiate a Phase I multiple dose safety study.
Phenserine: Axonyx's lead compound for AD, Phenserine has a dual
mechanism of action: acetylcholinesterase inhibition and the lowering
of A beta 42. Acetylcholinesterase is an enzyme active in the nerve
synapse that degrades the neurotransmitter acetylcholine in the brain
and other tissues of the body. Phenserine's dual mechanism of action
suggests that it has the potential to improve memory and cognition as
well as slow disease progression. Phenserine was evaluated in a Phase
III trial where the observed improvement in memory and cognition did
not achieve statistical significance over placebo. Phenserine has been
licensed to Daewoong for commercialization in South Korea and Axonyx
is seeking strategic partners for Phenserine in other markets.
Posiphen(TM): Axonyx's Phase I compound has consistently been
shown to significantly reduce the levels of A beta 42 in preclinical
animal studies. It is believed that Posiphen's mechanism of action is
through RNA translational inhibition and it is currently in
development as a potential treatment to slow or prevent the
progression of AD.
There are also three preclinical candidates in the pipeline: two
TorreyPines compounds, targeted for the treatment of AD are a
follow-on M1 agonist, NGX292, and NGX555, a gamma-secretase modulator
discovered by TorreyPines; and Axonyx's butyrylcholinesterase
inhibitor Bisnorcymserine (BNC) for the potential symptomatic
treatment of severe AD.
Management and Organization
Following the closing of the transaction, Dr. Neil Kurtz,
President and Chief Executive Officer of TorreyPines will become
President and Chief Executive Officer of the combined company. Evelyn
Graham, currently Vice President, Corporate Development of TorreyPines
will become the company's Chief Operating Officer; and Craig Johnson,
currently Chief Financial Officer, Dr. Michael Murphy, currently Chief
Medical Officer and Dr. Steven Wagner, currently Chief Scientific
Officer of TorreyPines will retain their respective positions in the
combined entity. The combined company's Board of Directors is expected
to consist of a total of five current TorreyPines directors and three
current Axonyx directors.
Piper Jaffray & Co. served as financial advisor to TorreyPines.
Banc of America Securities LLC served as financial advisor to Axonyx.
Conference Call/Webcast Information
Axonyx and TorreyPines management will host a joint conference
call/webcast to discuss matters mentioned in this release. The audio
webcast with slides is scheduled for today, June 8, at 9:00 a.m.
Eastern Time and can be accessed at the Axonyx corporate website at
www.axonyx.com. Please note that this call/webcast will not include a
question and answer session; shareholders and interested parties are
therefore encouraged to view the audio/slide webcast. The audio/slide
webcast will be archived for six months through December 6, 2006.
To listen to the call by telephone, parties may alternatively dial
(877) 660-6853 or (201) 612-7415, account number: 286; confirmation
identification: 205355 beginning at 9:00 a.m. ET to access the audio
portion of the presentation. The related slide presentation can be
downloaded for review at www.axonyx.com. In addition, a telephonic
archive will be available through June 20, 2006.
Additional Information about the Merger and Where to Find It
In connection with the Merger, Axonyx and TorreyPines Therapeutics
intend to file relevant materials with the Securities and Exchange
Commission (SEC), including a registration statement on Form S-4 that
will contain a prospectus and a joint proxy statement. Investors and
security holders of Axonyx and TorreyPines Therapeutics are urged to
read these materials when they become available because they will
contain important information about Axonyx, TorreyPines Therapeutics
and the merger. The proxy statement, prospectus and other relevant
materials (when they become available), and any other documents filed
by Axonyx with the SEC, may be obtained free of charge at the SEC's
web site at www.sec.gov. In addition, investors and security holders
may obtain free copies of the documents filed with the SEC by Axonyx
by directing a written request to: Axonyx, 500 Seventh Avenue, 10th
Floor, New York, NY 10018, Attention: Investor Relations. Investors
and security holders are urged to read the proxy statement, prospectus
and the other relevant materials when they become available before
making any voting or investment decision with respect to the merger.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in any
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the securities
laws of any such jurisdiction. No offering of securities shall be made
except by means of a prospectus meeting the requirements of Section 10
of the Securities Act of 1933, as amended.
Participants in the Solicitation
Axonyx and its directors and executive officers and TorreyPines
Therapeutics and its directors and executive officers may be deemed to
be participants in the solicitation of proxies from the stockholders
of Axonyx in connection with the proposed transaction. Information
regarding the special interests of these directors and executive
officers in the merger transaction will be included in the proxy
statement/prospectus referred to above. Additional information
regarding the directors and executive officers of Axonyx is also
included in Axonyx's Annual Report on Form 10-K for the year ended
December 31, 2005, which was filed with the SEC on March 16, 2006.
This document is available free of charge at the SEC's web site
(www.sec.gov) and from Investor Relations at Axonyx at the address
described above.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a biopharmaceutical company that
discovers and develops small molecule drugs to treat diseases and
disorders of the central nervous system. Led by an accomplished
management team, TorreyPines is leveraging novel drug targets and
technologies to deliver new therapies for migraine; chronic pain,
including neuropathic pain; and Alzheimer's disease. Its therapies are
intended to offer significant advantages over current therapies.
Further information is available at www.torreypinestherapeutics.com.
About Axonyx
Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in
the acquisition and development of proprietary pharmaceutical
compounds for the treatment of CNS disorders. Axonyx currently has
three compounds in development for Alzheimer's disease, namely
Phenserine - a potential symptomatic and disease progression treatment
of mild to moderate Alzheimer's disease (AD), Posiphen(TM) - a
potential disease progression treatment for AD now in Phase I, and
BisNorCymserine (BNC) - a potential symptomatic treatment of severe AD
now in pre-Investigational New Drug (IND) stage. Additional
information can be found at www.axonyx.com.
This press release contains forward-looking statements or
predictions, including statements regarding the potential closing of
the proposed merger between Axonyx and TorreyPines Therapeutics, the
trading of the combined company's stock on the NASDAQ Stock Market,
the amount of cash expected to be held by the combined company at
closing, the timing for anticipated occurrence of key milestones
related to each company's product candidates, the characteristics and
possible uses of the product candidates of each of Axonyx and
TorreyPines Therapeutics, the expected advantages of combining Axonyx
and TorreyPines Therapeutics, and the expected timing of closing of
the merger. Actual results may differ materially from the above
forward-looking statements due to a number of important factors,
including the possibility that the proposed transaction with
TorreyPines Therapeutics may not ultimately close for any of a number
of reasons, including, but not limited to, Axonyx not obtaining
shareholder approval of the issuance of shares and warrants in the
merger, the change in control resulting from the merger or the reverse
split of Axonyx common stock; TorreyPines Therapeutics not obtaining
shareholder approval of the merger, the possibility that NASDAQ will
not approve the listing of the combined company's shares for trading
on the NASDAQ Stock Market or that the combined company will not be
able to meet the continued listing requirements after the closing of
the merger; that Axonyx and TorreyPines Therapeutics will forego
business opportunities while the merger is pending; that prior to the
closing of the proposed transaction, the businesses of the companies,
including the retention of key employees, may suffer due to
uncertainty; and even in the event the transaction is completed, that
combining Axonyx and TorreyPines Therapeutics may not result in a
stronger company, that the technologies and clinical programs of the
two companies may not be compatible and that the parties may be unable
to successfully execute their integration strategies or realize the
expected benefits of the merger.
This press release may contain forward-looking statements or
predictions. These statements represent our judgment to date, and are
subject to risks and uncertainties that could materially affect the
Company, including those risks and uncertainties described in the
documents Axonyx files from time to time with the SEC, specifically
Axonyx's annual report on Form 10-K. Specifically, with respect to our
drug candidates Phenserine, Posiphen(TM) and BisNorCymserine, Axonyx
cannot assure that: any preclinical studies or clinical trials,
whether ongoing or conducted in the future, will prove successful, and
if successful, that the results can be replicated; safety and efficacy
profiles of any of its drug candidates will be established, or if
established, will remain the same, be better or worse in future
clinical trials, if any; pre-clinical results related to cognition and
the regulation of beta-APP will be substantiated by ongoing or future
clinical trials, if any, or that any of its drug candidates will be
able to improve the signs or symptoms of their respective clinical
indication or slow the progression of Alzheimer's disease; any of its
drug candidates will support an NDA filing, will be approved by the
FDA or its equivalent, or if approved, will prove competitive in the
market; or that Axonyx will have or obtain the necessary financing to
support its drug development programs. Axonyx cannot assure that it
will be successful with respect to identifying a (sub-) licensing
partner for any of its compounds. Axonyx undertakes no obligation to
publicly release the result of any revisions to such forward-looking
statements that may be made to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated events.