Full Press Release Details
Therapeutics, Inc. Completes $20 Million Financing and Reverse Merger with
offering provides new funding as Nile Therapeutics, Inc. becomes a publicly
Calif., Sept. 18 -- Nile Therapeutics, Inc. ("Nile"), a biopharmaceutical
company focused on developing therapies for cardiovascular disease, announced
the successful completion of its merger with SMI Products, Inc. ("SMI") and
transition to a publicly reporting company. Until Nile receives its new ticker
symbol, shares of its common stock will continue to trade under the ticker
previously announced, on August 15, 2007, Nile, Nile Merger Sub, Inc. and SMI
entered into a merger agreement that called for Nile to acquire Nile Merger
Inc. in a statutory merger, with Nile becoming the wholly-owned subsidiary
SMI. This merger was completed on September 17, 2007. Immediately thereafter,
Nile merged with and into SMI, and SMI changed its name to Nile Therapeutics,
the completion of the merger, Nile raised approximately $20 million through
private sale of approximately 7 million shares of common stock to new and
existing investors. The financing syndicate, which was led by Wexford Capital
LLC, also included RIT Capital Partners, plc, Life Science Capital Master Fund,
and other select institutional and qualified investors. Following the closing
the financing Nile appointed Dr. Paul A. Mieyal of Wexford Capital, to serve
a member of Nile's Board of Directors. Riverbank Capital Securities, Inc.,
NASD member broker dealer, acted as placement agent in connection with the
proceeds from the financing will be used to fund further development of Nile's
pipeline, which includes its lead compound, CD-NP, a natriuretic peptide being
developed to treat heart failure, and 2NTX-99, a pre-clinical small molecule
with nitric oxide (NO) donating properties.
novel chimeric natriuretic peptide in Phase I clinical studies for the treatment
of heart failure, is a selective NPRB agonist which, in vivo, has been shown
have potent renal enhancement and cardiac unloading properties but with minimal
hypotensive effects compared with competitive products. CD-NP is a
rationally-designed synthetic peptide designed to incorporate favorable
properties of naturally occurring natriuretic peptides. Data from Nile's
recently completed Phase Ia study in healthy volunteers confirmed several
pre-clinical findings, including that CD-NP activated its target receptor in
humans, preserved renal function and caused increases in natriuresis and
diuresis at doses associated with a minimal effect on mean arterial pressure.
Nile believes that CD-NP could provide a valuable new treatment option for
is a novel small molecule that has been shown in vivo and in vitro to inhibit
the synthesis and action of thromboxane (TXA2), enhance the production of
prostacyclin (PGI2) and supply a pharmacological amount of nitric oxide (NO)
the vasculature. Nile believes that the unique activity profile of 2NTX-99
potential utility in a range of atherosclerotic, thrombotic and microvascular
successful financing and merger leaves Nile with a strong balance sheet and
corporate structure." said Peter Strumph, CEO of Nile Therapeutics, Inc. "This
infusion of capital is a validation of our management team, our focused clinical
development strategy, our pipeline, and the unmet need which exists for the
treatment of patients with heart failure. Nile's lead compound CD-NP has
recently completed its first clinical study in healthy volunteers and will
be tested in heart failure patients in several clinical studies planned to
before the end of the year."
securities sold in the recent private offering have not been registered under
the Securities Act of 1933 and may not be resold absent registration under
exemption from such Act. Nile has agreed to file with the Securities and
Exchange Commission a registration statement for the resale of the securities
held by the investors in the offering by November 10, 2007. This press release
shall not constitute an offer to sell or the solicitation of an offer to buy
shall there be any sale of these securities in any state in which such offer,
solicitation or sale would be unlawful prior to registration or qualification
under the securities laws of any such state.
Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops
innovative products for the treatment of cardiovascular disease and other areas
of unmet medical need. Nile is initially focusing its efforts on developing
lead compound, CD-NP, a novel chimeric peptide in Phase I studies for the
treatment of heart failure and 2NTX-99, a small molecule, pre- clinical,
anti-atherothrombotic agent with nitric oxide donating properties. A key
component of the Company's strategy is to acquire the global rights to
additional compounds to expand its portfolio. More information on Nile can
found at www.nilethera.com.
extent that statements in this press release are not strictly historical,
including statements as to business strategy, outlook, objectives, future
milestones, plans, intentions, goals, future financial conditions, future
collaboration agreements, the success of Nile's product development, events
conditioned on stockholder or other approval, or otherwise as to future events,
all such statements are forward-looking, and are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995.
forward-looking statements are subject to certain risks and uncertainties that
could cause actual results to differ materially from the statements made.
Examples of the risks and uncertainties include, but are not limited to: the
risk that we may not successfully develop and market our products, and even
we do, we may not become profitable; risks relating to the progress of our
research and development; risks relating to the rigorous regulatory approval
process required for any products that we may develop independently, with our
development partners or in connection with our collaboration arrangements;
risk that changes in the national or international political and regulatory
environment may make it more difficult to gain U.S. Food and Drug
Administration, or FDA or other regulatory approval of our drug product
candidates; risks that the FDA or other regulatory authorities may not accept
any applications we file; risks that the FDA or other regulatory authorities
withhold or delay consideration of any applications that we file or limit such
applications to particular indications or apply other label limitations; risks
that, after acceptance and review of applications that we file, the FDA or
regulatory authorities will not approve the marketing and sale of our drug
product candidates; risks relating to our own drug manufacturing operations
the drug manufacturing operations of our third-party suppliers and contract
manufacturers; risks relating to the ability of our development partners and
third-party suppliers of materials, drug substance and related components to
provide us with adequate supplies and expertise to support manufacture of drug
product for initiation and completion of our clinical studies; risks relating
the transfer of our manufacturing technology to third-party contract
manufacturers, and the risk that recurring losses, negative cash flows and
inability to raise additional capital could threaten our ability to continue
and biotechnology companies have suffered significant setbacks in advanced