PHILADELPHIA, May 15, 2018 /PRNewswire/ -- Aevi Genomic
Medicine, Inc. (NASDAQ: GNMX) (the "Company") announced today
financial and operational results for the three months ended
March 31, 2018 and provided an
overview of the Company's recent corporate progress.
First Quarter Financial Results and Corporate
Highlights
- First quarter highlights include continued advancement and
strengthening of the Company's pipeline through a combination of
internal programs and external collaborations, with multiple data
read-outs anticipated in 2018.
-
- AEVI-001: The Company continues screening and recruitment
efforts for its Phase 2 (ASCEND) clinical trial in the mGluR
mutation positive genetic subset of pediatric and adolescent
patients with Attention Deficit Hyperactivity Disorder (ADHD) to
confirm genetic responders to AEVI-001. The primary and secondary
endpoints in the trial are the change from baseline in the
ADHD-RS-5 Total Score at six weeks and the percentage of subjects
who respond as determined by the Clinical Global Impression of
Improvement (CGI-I) at six weeks. Data from the study are expected
by mid-2018.
- AEVI-002: The Company has completed the addition of three new
clinical sites and patient screening is underway for its Phase
1b open-label, signal-finding study
which will evaluate the safety, tolerability, pharmacokinetics and
short-term efficacy of the Anti-Light Monoclonal Antibody AEVI-002
in diseased patients that have previously failed anti-tumor
necrosis factor alpha (anti-TNFα) treatment. The study will be
conducted at sites across the United
States with the potential to expand to clinical trial sites
outside the United States.
AEVI-002 will be administered every 14 days at one of two dosage
levels: 1.0 mg/kg or 3.0 mg/kg for up to eight weeks. The endpoints
of the study include endoscopic evaluation, Crohn's Disease
Activity Index ratings, and safety. Data from the study are
expected by year-end 2018.
- AEVI-005: The Company broadened its relationship with Kyowa
Hakko Kirin (KHK) with an option agreement for the development of
an early stage, first-in-class monoclonal antibody (AEVI-005)
program targeting an undisclosed ultra-orphan pediatric rare
disease. This is the second monoclonal antibody signed in
collaboration with KHK and reflects the Company's unique ability to
leverage its genetic expertise in rare and orphan pediatric
diseases. The Company intends to initiate a preclinical research
program during the second quarter of 2018.
"We have made great progress during the first quarter and we are
diligently working towards important data readouts in 2018 on our
most advanced programs – AEVI-001 and AEVI-002," said Mike Cola, CEO of the Company. "While AEVI-001
remains the top priority for the Company with data from the
"ASCEND" trial expected by mid-year, we are equally enthusiastic
about the broadening of our relationship with KHK and in the
potential of AEVI-002. We look forward to providing updates
throughout the year as we progress towards these key
catalysts."
First Quarter 2018 Financial Results
The Company had cash and cash equivalents of $26.52 million at March
31, 2018, compared to $33.73
million as of December 31,
2017. The decrease in cash was primarily related to the
advancement of its AEVI-001 program. The Company expects the
current cash balance to fund operations into early 2019.
Research and development expenses for the three months ended
March 31, 2018 were $6.56 million, decreasing from $7.95 million for the same period in 2017 mainly
related to decreasing clinical trial/development
activities.
General and administrative expenses for the three months ended
March 31, 2018 were $2.17 million, decreasing from $2.99 million for the same period in 2017
primarily due to decreased costs following the closure of the
Company's operations in Israel.
For the three months ended March 31,
2018, the Company reported a net loss of $8.71 million or $0.15 per share, compared with a net loss of
$10.92 million or $0.29 per share for the same period in 2017.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
|
|
|
|
March 31,
2018
|
|
|
December 31,
2017
|
|
|
|
Unaudited
|
|
|
Audited
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
26,520
|
|
|
$
|
33,729
|
|
Prepaid expenses and
other current assets
|
|
|
801
|
|
|
|
893
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
|
27,321
|
|
|
|
34,622
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lease
deposits
|
|
|
11
|
|
|
|
11
|
|
Property and
equipment, net
|
|
|
69
|
|
|
|
85
|
|
Other long-term
assets
|
|
|
33
|
|
|
|
43
|
|
|
|
|
|
|
|
|
|
|
Total long-term
assets
|
|
|
113
|
|
|
|
139
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
27,434
|
|
|
$
|
34,761
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
1,685
|
|
|
$
|
943
|
|
Other accounts
payable and accrued expenses
|
|
|
3,054
|
|
|
|
3,197
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
4,739
|
|
|
|
4,140
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
4,739
|
|
|
|
4,140
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock -
$0.0001 par value; 200,000,000 shares
authorized; 59,337,265 shares issued and outstanding at March
31,
2018; 59,332,265 shares issued and outstanding at December 31,
2017
|
|
$
|
6
|
|
|
$
|
6
|
|
Additional paid-in
capital
|
|
|
246,376
|
|
|
|
245,593
|
|
Accumulated
deficit
|
|
|
(223,687)
|
|
|
|
(214,978)
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
|
22,695
|
|
|
|
30,621
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
27,434
|
|
|
$
|
34,761
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
|
|
|
|
|
|
Three months
ended
March 31,
|
|
|
|
|
2018
|
|
|
2017
|
|
|
|
|
|
Unaudited
|
|
Research and
development expenses
|
|
|
$
|
6,561
|
|
|
$
|
7,947
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
|
|
2,174
|
|
|
|
2,988
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
|
(8,735)
|
|
|
|
(10,935)
|
|
Financial
income
|
|
|
|
|
26
|
|
|
|
18
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$
|
(8,709)
|
|
|
$
|
(10,917)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share
|
|
|
|
$
|
(0.15)
|
|
|
$
|
(0.29)
|
|
Weighted average
number of
common stock used in
computing
basic and diluted
loss per share
|
|
|
|
|
59,334,821
|
|
|
|
37,108,261
|
|
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, 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
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SOURCE Aevi Genomic Medicine, Inc.