Vivani Medical, Inc. (Nasdaq: VANI) ("Vivani" or the "Company"),
an innovative, preclinical-stage biopharmaceutical company
developing novel, long-term drug implants, today announced that it
has entered into a securities purchase agreement with an
institutional investor to purchase 3,947,368 shares of common stock
and warrants to purchase up to an aggregate of 3,947,368 shares of
common stock at a purchase price of $3.80 per share and
accompanying warrant in a registered direct offering. The warrants
have an exercise price of $3.80 per share, are exercisable
immediately upon issuance, and will expire three years following
the date of issuance.
Maxim Group LLC is acting as the sole placement agent in
connection with the offering. ThinkEquity is acting as financial
advisor to the Company in connection with the offering.
The gross proceeds to the Company are expected to be
approximately $15.0 million before deducting the placement agent
fees and other estimated offering expenses. The offering is
expected to close on or about March 5, 2024, subject to the
satisfaction of customary closing conditions.
The offering is being made pursuant to an effective shelf
registration statement on Form S-3 (File No. 333-256904) previously
filed with the U.S. Securities and Exchange Commission (“SEC”),
which was declared effective on June 14, 2021. The offering is made
only by means of a prospectus forming a part of the effective
registration statement relating to the offering. A prospectus
supplement relating to the shares of common stock and warrants will
be filed by the Company with the SEC. When available, copies of the
prospectus supplement relating to the registered direct offering,
together with the accompanying prospectus, can be obtained at the
SEC's website at www.sec.gov or from Maxim Group LLC, 300 Park
Avenue, New York, NY 10022, at (212) 895-3745.
This press release shall not constitute an offer to sell or a
solicitation of an offer to buy any of the securities described
herein, nor shall there be any sale of these securities in any
state or other jurisdiction in which such offer, solicitation or
sale would be unlawful prior to the registration or qualification
under the securities laws of any such state or other
jurisdiction.
About Vivani Medical, Inc.:
Leveraging its proprietary NanoPortal™ platform, Vivani Medical
develops biopharmaceutical implants designed to deliver drug
molecules steadily over extended periods of time with the goal of
guaranteeing adherence, and potentially to improve medication
tolerability. Vivani’s NPM-115 and NPM-119 are miniature,
six-month, GLP-1 implants in development for the treatment of
chronic weight management in obese or overweight patients and type
2 diabetes, respectively. Both NPM-115 and NPM-119 are exenatide
based products with a higher-dose associated with NPM-115 for the
treatment of chronic weight management in obese or overweight
patients. An IND for NPM-119’s first-in-human study LIBERATE-1 has
been submitted and is on clinical hold pending requests by the FDA
for additional chemistry, manufacturing, and controls (CMC)
information. Vivani anticipates submitting the requested CMC
information to the FDA in the first half of 2024. LIBERATE-1 is a
randomized, 12-week investigation of the safety, tolerability, and
full pharmacokinetic profile of NPM-119 in patients with type 2
diabetes. Vivani is also preparing to submit an IND for a
first-in-human study with NPM-115 for the treatment of chronic
weight management later this year. These NanoPortal™ implants are
designed to provide patients with the opportunity to realize the
full potential benefit of their medication by avoiding the
challenges associated with the daily or weekly administration of
orals and injectables. Medication non-adherence occurs when
patients do not take their medication as prescribed. This affects
an alarming number of patients, approximately 50%, including those
taking daily pills. Medication non-adherence, which contributes to
more than $500 billion in annual avoidable healthcare costs and
125,000 potentially preventable deaths annually in the U.S. alone,
is a primary and daunting reason why obese or overweight patients,
and patients taking type 2 diabetes or other chronic disease
medications face significant challenges in achieving positive
real-world effectiveness.
Vivani’s wholly owned subsidiary Cortigent is developing
targeted neurostimulation systems intended to help patients recover
critical body functions. Investigational devices include Orion®,
designed to provide artificial vision to people who are profoundly
blind, and a new system intended to accelerate the recovery of arm
and hand function in patients who are partially paralyzed due to
stroke. Vivani continues to assess strategic options for advancing
Cortigent’s pioneering technology.
Forward-Looking Statements
This press release contains certain "forward-looking statements"
within the meaning of the "safe harbor" provisions of the US
Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: "target," "believe,"
"expect," "will," "may," "anticipate," "estimate," "would,"
"positioned," "future," and other similar expressions that in this
press release, including statements regarding the Company’s ability
to satisfy closing conditions for this offering, our business,
products in development, including the therapeutic potential
thereof, plans to address any requests from the FDA related to the
agency’s current clinical hold on NPM-119, the initiation of the
LIBERATE-1 trial and reporting of trial results, the planned
development therefor, our emerging development plans for NPM-115,
NPM-139, or our plans with respect to Cortigent and its proposed
initial public offering, technology, strategy, cash position and
financial runway. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based
only on our current beliefs, expectations, and assumptions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict and many of which are outside of our
control. Actual results and outcomes may differ materially from
those indicated in the forward-looking statements. Therefore, you
should not rely on any of these forward-looking statements.
Important factors that could cause actual results and outcomes to
differ materially from those indicated in the forward-looking
statements include, among others, risks related to the development
and commercialization of our products, including NPM-115 and
NPM-119; delays and changes in the development of our products,
including our ability to address any requests from the FDA related
to LIBERATE-1 and to commence clinical development of NPM-119,
including as a result of applicable laws, regulations and
guidelines, potential delays in submitting and receiving regulatory
clearance or approval to conduct our development activities, risks
related to the initiation, enrollment and conduct of our planned
clinical trials and the results therefrom; our history of losses
and our ability to access additional capital or otherwise fund our
business; market conditions and the ability of Cortigent to
complete its initial public offering. There may be additional risks
that the Company considers immaterial, or which are unknown. A
further list and description of risks and uncertainties can be
found in the Company’s most recent Annual Report on Form 10-K filed
with the SEC filed on March 31, 2023, as updated by our subsequent
Quarterly Reports on Form 10-Q. Any forward-looking statement made
by us in this press release is based only on information currently
available to the Company and speaks only as of the date on which it
is made. The Company undertakes no obligation to publicly update
any forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of added information,
future developments or otherwise, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20240229960811/en/
Company Contact: Donald Dwyer Chief Business Officer
info@vivani.com (415) 506-8462
Investor Relations Contact: Brigid A. Makes Chief Financial
Officer investors@vivani.com (415) 506-8462
Media Contact: Sean Leous ICR Westwicke Sean.Leous@westwicke.com
(646) 866-4012
Vivani Medical (NASDAQ:VANI)
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