PHILADELPHIA, Nov. 1, 2018 /PRNewswire/ -- Aevi Genomic
Medicine, Inc. (NASDAQ: GNMX) (the "Company") announced today
financial and operational results for the three months ended
September 30, 2018 and provided
an overview of the Company's recent corporate progress.
Third Quarter Financial Results and Recent Corporate
Highlights
- AEVI-001 ASCEND clinical trial update: In October 2018, the Company announced that it
completed enrollment for the ASCEND trial, a genomically-guided
Phase 2 study of AEVI-001, a novel, non-stimulant therapy in
pediatric and adolescent patients with Attention Deficit
Hyperactivity Disorder (ADHD). Part A of the trial is studying a
mGluR mutation positive genetic subset of pediatric and adolescent
ADHD patients. Part B of the trial is studying pediatric and
adolescents ADHD patients without mGluR mutations. Individual and
pooled analysis of Parts A and B will be conducted simultaneously
and will inform the design of the planned Phase 3 development
program in ADHD, expected to utilize AEVI-004, a co-crystal version
of AEVI-001. The Company currently anticipates announcing top-line
data for both Parts A and B in January
2019.
- AEVI-004, co-crystal version of AEVI-001: AEVI-004 is a
new chemical entity (NCE) co-crystal of AEVI-001 that has
comparatively greater stability and a higher melting point than
AEVI-001, while being engineered to maintain substantially similar
solubility, dissolution and pharmacokinetics. AEVI-004 is expected
to provide composition of matter patent protection through 2039
with the potential to broaden the applicability of the program
beyond ADHD into other neuropsychiatric diseases. The U.S. Food and
Drug Administration (FDA) has provisionally indicated that existing
toxicology and pathology studies can support clinical development
with AEVI-004. Assuming positive results from the ongoing Phase 2
ASCEND clinical trial and following minimal bridging preclinical
and clinical pharmacological studies requested by FDA, the Company
anticipates progressing the molecule directly into Phase 3 studies
with limited impact on the program timeline.
- AEVI-002 enrollment update: Increased patient screening
at multiple clinical trial sites in the
United States continues for the Company's Phase 1b open-label, signal-finding trial to evaluate
the safety, tolerability, pharmacokinetics and short-term efficacy
of the Anti-LIGHT Monoclonal Antibody (AEVI-002) in severe
pediatric onset Crohn's disease patients that have previously
failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.
Expanding the number of clinical trial sites has led to increased
screening activity, but the Company has not yet enrolled any
patients into this trial. Assuming a small number of patients can
be enrolled by the end of the first quarter 2019, initial data is
expected by mid-year 2019.
- AEVI-005: The Company initiated a preclinical research
program for AEVI-005, the second monoclonal antibody in development
as part of the Company's ongoing collaboration with Kyowa Hakko
Kirin, during the second quarter of 2018. AEVI-005 is being studied
in an undisclosed ultra-orphan auto-immune pediatric disease.
"It has been a productive quarter for Aevi," said Mike Cola, Chief Executive Officer of the
Company. "We were able to successfully utilize our ATM facility to
bring in approximately $5.0 million
in capital which has allowed us to move forward in our
programs. Completing enrollment in Parts A and B of the
ASCEND trial was an important milestone for the Company, and we
look forward to sharing data from the trial in January 2019. In addition to progress with
AEVI-001, we are developing AEVI-004 as a follow-on to AEVI-001 in
ADHD and potentially other adjacent neuropsychiatric indications
and are making progress in our preclinical work on AEVI-005."
Third Quarter 2018 Financial Results
The Company had cash and cash equivalents of $19.6 million at September
30, 2018, compared to $33.7
million as of December 31,
2017. The decrease in cash was primarily related to the
advancement of the Company's AEVI-001 and AEVI-002 programs.
For the quarter ended September 30,
2018, the Company sold 5,426,151 shares of common stock
under its ATM Facility for net proceeds of $5.0 million.
Based upon current management projections, the Company expects
the current cash balance to fund operations into the first quarter
of 2019.
Research and development expenses for the three months ended
September 30, 2018 were $5.1 million, decreasing from $6.3 million for the same period in 2017 mainly
related to decreased clinical development and research
activities.
General and administrative expenses for the three months ended
September 30, 2018 were $2.2 million, approximately equivalent to
$2.3 million for the same period in
2017.
For the three months ended September 30,
2018, the Company reported a net loss of $7.2 million or $0.12 per share, compared with a net loss of
$8.6 million or $0.23 per share for the same period in 2017.
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 US, the CDC estimates that 6.4 million children
4-17 years of age (11%) have ever 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 US FDA or any other regulatory agencies.
About AEVI-004
AEVI-004 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.
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 clinica trials, its
development and business strategy, its product candidates and the
plans and objectives of management for future operations. 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
CONDENSED
CONSOLIDATED BALANCE SHEETS (In thousands, except share
data)
|
|
|
|
|
|
September 30
2018
|
|
|
December 31,
2017
|
|
|
|
Unaudited
|
|
|
Audited
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
19,602
|
|
|
$
|
33,729
|
|
Prepaid expenses and
other current assets
|
|
|
538
|
|
|
|
893
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
|
20,140
|
|
|
|
34,622
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lease
deposits
|
|
|
11
|
|
|
|
11
|
|
Property and
equipment, net
|
|
|
36
|
|
|
|
85
|
|
Other long-term
assets
|
|
|
-
|
|
|
|
43
|
|
|
|
|
|
|
|
|
|
|
Total long-term
assets
|
|
|
47
|
|
|
|
139
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
20,187
|
|
|
$
|
34,761
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
1,585
|
|
|
$
|
943
|
|
Other accounts
payable and accrued expenses
|
|
|
4,850
|
|
|
|
3,197
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
6,435
|
|
|
|
4,140
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
6,435
|
|
|
|
4,140
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock -
$0.0001 par value; 200,000,000 shares authorized; 64,766,882 shares
issued and outstanding at September 30, 2018; 59,332,265 shares
issued and outstanding at December 31, 2017
|
|
$
|
6
|
|
|
$
|
6
|
|
Additional paid-in
capital
|
|
|
252,873
|
|
|
|
245,593
|
|
Accumulated
deficit
|
|
|
(239,127)
|
|
|
|
(214,978)
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
|
13,752
|
|
|
|
30,621
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
20,187
|
|
|
$
|
34,761
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands,
except share and per share data)
|
|
|
|
Nine months
ended
September 30,
|
|
Three months
ended
September 30,
|
|
|
|
2018
|
|
|
|
2017
|
|
2018
|
|
|
2017
|
|
|
|
Unaudited
|
|
Unaudited
|
|
Research and
development expenses
|
$
|
17,433
|
|
|
$
|
19,913
|
|
$
|
5,125
|
|
|
$
|
6,299
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
6,852
|
|
|
|
7,627
|
|
|
2,174
|
|
|
|
2,270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(24,285)
|
|
|
|
(27,540)
|
|
|
(7,299)
|
|
|
|
(8,569)
|
|
Financial (expense) /
income
|
|
136
|
|
|
|
(15)
|
|
|
50
|
|
|
|
(36)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(24,149)
|
|
|
$
|
(27,555)
|
|
$
|
(7,249)
|
|
|
$
|
(8,605)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share
|
$
|
(0.40)
|
|
|
$
|
(0.74)
|
|
$
|
(0.12)
|
|
|
$
|
(0.23)
|
|
Weighted average
number of common stock used in computing basic and diluted loss per
share
|
|
60,240,787
|
|
|
|
37,109,455
|
|
|
62,019,780
|
|
|
|
37,110,043
|
|
View original
content:http://www.prnewswire.com/news-releases/aevi-genomic-medicine-reports-third-quarter-2018-financial-results-and-provides-business-update-300741967.html
SOURCE Aevi Genomic Medicine, Inc.