PHILADELPHIA, Aug. 21, 2018 /PRNewswire/ -- Aevi Genomic
Medicine, Inc. (NASDAQ: GNMX) (the Company) today announced the
sale of 5.1 million shares of its common stock for aggregate
proceeds of $4.9 million, before expenses. The sales were
through the Company's existing ATM program, for which JMP
Securities LLC acts as the Company's sales agent.
- The Company recently announced the completion of enrollment in
Part A of the ASCEND trial and intends to use the net proceeds
raised from the ATM to accelerate Part B of the ASCEND trial.
- Enrollment in Part B of the ASCEND trial has been initiated and
will study patients without mGluR mutations.
- The Company has approximately 1,500 mGluR mutation negative
patients in the ASCEND database from which it can enroll patients
for Part B of the study.
- Pooled analysis of Part A and Part B of the ASCEND trial will
also be conducted, if appropriate. A pooled analysis may provide
greater power and enhance the ability to detect a smaller treatment
effect.
- The Company currently anticipates top-line data for Parts A and
B of the ASCEND trial during the fourth quarter of 2018.
"We are pleased to be in a position to accelerate Part B of the
ASCEND trial. AEVI-004 increases the importance and potential
value of Part B of the ASCEND trial as it allows for long patent
protection for treating all ADHD patients. mGluR mutation negative
patients make up approximately 75-80% of the approximately
$11 billion ADHD market," said
Mike Cola, CEO of the Company.
The shares of common stock sold through the Company's ATM
program have been issued and sold pursuant to the Company's shelf
registration statement on Form S-3 (File No. 333-209737),
previously filed with the Securities and Exchange Commission
("SEC") on February 26, 2016 and
declared effective by the SEC on April 1,
2016. A prospectus supplement related to the offering was
filed with the SEC on May 15, 2018.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy shares of the common stock nor
shall there be any sale of the common stock 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.
About the ASCEND Clinical Trial
ASCEND is an adaptive, 6-week, double-blind parallel-group study
in children and adolescents (ages 6-17 years) with ADHD with and
without copy number variants (CNVs) in specific genes implicated in
glutamatergic signaling and neuronal connectivity. Part A includes
subjects determined to have one of eight specific gene mutation(s)
implicated in glutamatergic signaling and neuronal
connectivity. Part B will assess subjects who do not have
CNVs in any of the specific gene mutation(s) implicated in
glutamatergic signaling and neuronal connectivity. Once
subjects are confirmed as eligible for each part of the study, they
are randomized to one of two treatment groups (AEVI-001 or placebo)
in a 1:1 ratio.
About AEVI-001
AEVI-001 is an oral non-stimulant pan selective
activator/modulator of mGluRs. The molecule has excellent
pharmacokinetic and metabolic profiles and crosses the blood brain
barrier.
The Company is developing AEVI-001 as a potential treatment
for a sub-population of Attention Deficit Hyperactivity Disorder
(ADHD) patients with genetic mutations that disrupt the mGluR
network. In the United States, the
Center for Disease Control and Prevention estimates that 6.4
million children 4-17 years of age (11%) have been diagnosed with
ADHD. Many ADHD patients remain unsatisfied with existing
therapies, particularly with respect to safety, tolerability and
treatment of comorbidities.
AEVI-001 is an investigational agent that has not been approved
by the U.S. Food and Drug Administration or any other regulatory
agencies.
About AEVI-004
AEVI-004 is an oral non-stimulant pan selective
activator/modulator of mGluRs. The molecule has excellent
pharmacokinetic and metabolic profiles and crosses the blood brain
barrier. The molecule is a co-crystal of AEVI-001,
crystallized with a pharmacologically inert conformer with a
favorable toxicological profile. The molecule's
pharmacological properties have been designed, and are expected, to
be very similar to those of AEVI-001. As such, the Company
believes that the molecule may progress directly to phase 3 studies
with only minimal bridging preclinical and clinical pharmacological
studies.
AEVI-004 has several distinct advantages over AEVI-001,
including better stability and better manufacturability owing to a
significantly higher melting point.
AEVI-004 is an investigational agent that has not been approved
by the U.S. Food and Drug Administration or any other regulatory
agencies.
About Aevi Genomic Medicine, Inc.
Aevi Genomic Medicine, Inc. is dedicated to unlocking the
potential of genomic medicine to translate genetic discoveries into
novel therapies. Driven by a commitment to patients with pediatric
onset life-altering diseases, the Company's research and
development efforts leverage an internal genomics platform and an
ongoing collaboration with the Center for Applied Genomics (CAG) at
The Children's Hospital of Philadelphia (CHOP).
Forward-looking Statements
This release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and as that term is defined
in the Private Securities Litigation Reform Act of 1995, which
include all statements other than statements of historical fact,
including (without limitation) those regarding the Company's
financial position, status and timing of clinical trials, its
development and business strategy, its product candidates and the
plans and objectives of management for future operations and future
financings. The Company intends that such forward-looking
statements be subject to the safe harbors created by such laws.
Forward-looking statements are sometimes identified by their use of
the terms and phrases such as "estimate," "project," "intend,"
"forecast," "anticipate," "plan," "planning, "expect," "believe,"
"will," "will likely," "should," "could," "would," "may" or the
negative of such terms and other comparable terminology. All such
forward-looking statements are based on current expectations and
are subject to risks and uncertainties. Should any of these risks
or uncertainties materialize, or should any of the Company's
assumptions prove incorrect, actual results may differ materially
from those included within these forward-looking statements.
Accordingly, no undue reliance should be placed on these
forward-looking statements, which speak only as of the date made.
The Company expressly disclaims any obligation or undertaking to
disseminate any updates or revisions to any forward-looking
statements contained herein to reflect any change in the Company's
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
As a result of these factors, the events described in the
forward-looking statements contained in this release may not
occur.
CONTACT:
Aevi Genomic Medicine, Inc.
Brian Piper
Brian.Piper@aevigenomics.com
Westwicke Partners
Chris Brinzey
339-970-2843
Chris.Brinzey@westwicke.com
MEDIA INQUIRIES:
FTI Consulting
Irma Gomez-Dib
+1212-850-5761
+1-415-706-9155
irma.gomez-dib@fticonsulting.com
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SOURCE Aevi Genomic Medicine, Inc.