PHILADELPHIA, March 13, 2018 /PRNewswire/ -- Aevi
Genomic Medicine, Inc. (NASDAQ: GNMX) (the Company) announced
today financial and operational results for the three and twelve
months ended December 31, 2017.
Fourth Quarter and Year-End Corporate Highlights
- Continued advancing and strengthening the Company's pipeline
through a combination of internal programs and external
collaborations:
-
- 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. Patient enrollment is
ongoing, with data expected by mid-2018.
- AEVI-002: The Company initiated a Phase 1b proof-of-concept (POC) study in mid-2017. The
open-label, signal-finding study is designed to evaluate the
safety, tolerability, and short-term efficacy of the Anti-Light
Monoclonal Antibody AEVI-002 in patients diagnosed with pediatric
Crohn's Disease who previously failed treatment with an Anti-TNFα
inhibitor. The endpoints of the study include endoscopic
evaluation, Crohn's Disease Activity Index ratings, and safety.
Patient recruitment is ongoing, and the Company is initiating three
additional sites in an effort to enhance enrollment. Data are
expected by year-end 2018.
- AEVI-005: Broadened 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
Aevi Genomic Medicine's unique ability to leverage its genetic
expertise in rare and orphan pediatric diseases. The Company
intends to initiate a preclinical research program during second
quarter 2018. Financial terms were not disclosed.
- Expanded its unique genomic research collaboration with
Children's Hospital of Philadelphia (CHOP).
-
- Granted an option for long-term exclusive access to certain
data and samples from the Center for Applied Genomics (CAG) biobank
and certain discoveries in rare and orphan diseases to accelerate
the identification of disease targets and development of potential
therapies in areas of unmet need.
- Renewed the Sponsored Research Agreement (SRA) with CHOP, which
marks the third renewal of sponsored research.
- Strengthened the balance sheet with the completion of a private
placement of shares for aggregate proceeds of $28.0 million, before expenses, which provides
the resources to continue the development of the Company's two lead
clinical programs, AEVI-001 and AEVI-002, and initiate preclinical
work on AEVI-005.
-
- The Children's Hospital of Philadelphia Foundation (the "CHOP
Foundation") was the lead investor, with additional participation
by other blue-chip investors.
- The CHOP Foundation has committed to provide up to an
additional $5.0 million of equity
financing through June 30, 2018,
subject to certain terms and conditions.
- Announced the addition of Matthew D.
Bayley, MD, MBA to the Company's Board of Directors. Dr.
Bayley serves as Senior Vice President and Chief Strategy Officer
at CHOP where he leads strategic planning and business development
working to advance CHOP's mission. His industry experience and
business insights will expand the Company's perspective and
strategic insights.
"2017 enabled us to further refine our approach to genomic
medicine and focus our efforts on genomically-targeted indications
that could increase the speed and probability of bringing therapies
to market for those with pediatric onset, life-altering diseases,"
said Mike Cola, CEO of Aevi Genomic
Medicine. "We continue to advance our pipeline and are pleased to
have broadened our relationships with both CHOP and KHK, providing
us with the resources to identify new targets and develop potential
therapies. We remain committed to our goals of delivering
clinical results in our lead programs in ADHD and Crohn's Disease
in 2018."
Fourth Quarter 2017 Financial Results
The Company had cash and cash equivalents of $33.73 million at December
31, 2017. The Company expects the current cash balance to
fund operations into early 2019.
Net research and development expenses for the three months ended
December 31, 2017 were $5.26 million, increasing slightly from
$5.14 million for the same period in
2016.
General and administrative expenses for the three months ended
December 31, 2017 were $1.90 million, decreasing from $3.35 million for the same period in 2016 mainly
due to the closure of operations in Israel.
For the quarter ended December 31,
2017 the Company reported a net loss of $7.16 million or $0.13 per share, compared with a net loss of
$8.48 million or $0.23 per share for the comparative quarter in
2016.
Full Year 2017 Financial Results
Net research and development expenses for year ended
December 31, 2017 decreased to
$25.18 million from $28.36 million in 2016. This decrease was
primarily driven by the closure of the Company's operations in
Israel of $3.40 million.
General and administrative expenses for the year ended
December 31, 2017 were $9.52 million, decreasing from $13.52 million in 2016 primarily due to severance
benefits recorded in 2016 related to termination of an officer of
$0.97 million, decreased stock
compensation expense related to options which have fully vested of
$2.00 million, and closure of the
Company's operations in Israel of
$0.84 million.
Conference Call and Webcast Information
Aevi Genomic Medicine will hold a conference call Tuesday, March 13, 2018 at 8:30 am ET to provide a corporate update. To
access the conference call by phone, please dial (877) 870-4263
(domestic) or (412) 317-0790 (international) and request to join
the Aevi Genomic Medicine's Conference Call.
The live webcast can be accessed under "Events" in the Investors
section of the Company's website at www.aevigenomics.com.
The archived webcast will be available for 30 days in the
Investor section of Aevi Genomic Medicine website
at www.aevigenomics.com.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In thousands,
except share data)
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
33,729
|
|
|
$
|
39,838
|
|
Prepaid expenses and
other current assets
|
|
|
|
893
|
|
|
|
335
|
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
|
|
34,622
|
|
|
|
40,173
|
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted lease
deposits
|
|
|
|
11
|
|
|
|
11
|
|
Property and
equipment, net
|
|
|
|
85
|
|
|
|
377
|
|
Other long-term
assets
|
|
|
|
43
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term
assets
|
|
|
|
139
|
|
|
|
388
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
|
$
|
34,761
|
|
|
$
|
40,561
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
|
$
|
943
|
|
|
$
|
137
|
|
Other accounts
payable and accrued expenses
|
|
|
|
3,197
|
|
|
|
5,446
|
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
|
4,140
|
|
|
|
5,583
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
|
4,140
|
|
|
|
5,583
|
|
|
|
|
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock -
$0.0001 par value; 200,000,000 shares authorized; 59,332,265 shares
issued and outstanding at December 31, 2017; 100,000,000 shares
authorized; 37,112,343 shares issued and 37,103,843 shares
outstanding at December 31, 2016
|
|
|
|
6
|
|
|
|
4
|
|
Additional paid-in
capital
|
|
|
|
245,593
|
|
|
|
215,008
|
|
Accumulated
deficit
|
|
|
|
(214,978)
|
|
|
|
(180,034)
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
|
|
30,621
|
|
|
|
34,978
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
|
$
|
34,761
|
|
|
$
|
40,561
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
|
|
December
31,
|
|
|
|
|
2017
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
$
|
25,176
|
|
$
|
28,552
|
|
|
$
|
18,356
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less:
|
|
|
|
|
|
|
|
|
|
|
|
Participation by the
Office of the Chief Scientist
|
|
|
-
|
|
|
(196)
|
|
|
|
(2,912)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses, net
|
|
|
25,176
|
|
|
28,356
|
|
|
|
15,444
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-recurring
research and development expenses resulting from
acquisition
|
|
|
-
|
|
|
|
|
|
|
8,170
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
9,524
|
|
|
13,523
|
|
|
|
12,954
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(34,700)
|
|
|
(41,879)
|
|
|
|
(36,568)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
expenses
|
|
|
(41)
|
|
|
(24)
|
|
|
|
(1,408)
|
|
Financial
income
|
|
|
27
|
|
|
15
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes on
income
|
|
|
(34,714)
|
|
|
(41,888)
|
|
|
|
(37,975)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxes on
income
|
|
|
-
|
|
|
16
|
|
|
|
17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(34,714)
|
|
$
|
(41,904)
|
|
|
$
|
(37,992)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per
share
|
|
$
|
(0.83)
|
|
$
|
(1.19)
|
|
|
$
|
(1.42)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted loss per
share
|
|
$
|
(0.83)
|
|
$
|
(1.19)
|
|
|
$
|
(1.45)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares of common stock used in computing basic loss per
share
|
|
|
41,675,814
|
|
|
35,161,823
|
|
|
|
26,783,623
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares of common stock used in computing diluted loss per
share
|
|
|
41,675,814
|
|
|
35,161,823
|
|
|
|
26,846,270
|
|
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
+1-212-850-5761
+1-415-706-9155
irma.gomez-dib@fticonsulting.com
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SOURCE Aevi Genomic Medicine, Inc.