PHILADELPHIA, Nov. 2, 2017 /PRNewswire/ -- Aevi Genomic
Medicine, Inc. (NASDAQ: GNMX) (the Company) announced today
financial and operational results for the quarter ended
September 30, 2017 and provided a
corporate update.
Third Quarter and Recent Corporate Highlights
- Initiated screening and recruitment for a Phase 2 clinical
trial in contactin-4 mutation-positive Attention Deficit
Hyperactivity Disorder ("CNTN4+ ADHD") (Part A) to confirm genetic
responders to AEVI-001. Data from the trial is expected by
mid-2018.
- Initiated work on CNTN4 in Autism Spectrum Disorder (ASD) to
better define the patient phenotype and design a proof-of-concept
study to begin in H1 2018.
- Continued recruitment for a Phase 1b proof-of-concept study of
AEVI-002 in Severe Pediatric Onset Crohn's Disease. Initial data
from the trial is anticipated by mid-2018.
- Completed the previously announced private placement of 22.2
million shares of common stock with warrants to purchase
approximately 4.0 million additional shares of common stock, for
aggregate proceeds of $28.0 million,
before expenses (the "PIPE"). 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.
- Current cash resources, including proceeds from the PIPE
transaction, are estimated to fund operations into early 2019,
including through the receipt of top-line data from AEVI-001 in
CNTN4+ ADHD Part A and initial data from the proof-of-concept trial
of AEVI-002 in Severe Pediatric Onset Crohn's Disease.
Third Quarter 2017 Financial Results
The Company had cash and cash equivalents of $14.96 million at September 30, 2017. The cash balance
reported in the quarter excludes the $28.0
million in gross proceeds from the PIPE transaction that
closed on October 17, 2017. The
Company expects the current cash balance, including the proceeds
from the PIPE offering, to fund operations into early 2019.
Research and development expenses for the three months ended
September 30, 2017 were $6.30 million, decreasing from $7.73 million for the same period in 2016 mainly
related to reduced clinical trial activities.
General and administrative expenses for the three months ended
September 30, 2017 were $2.27 million, decreasing from $3.04 million for the same period in 2016 mainly
due to decreased costs following the closure of our operations in
Israel and stock-based
compensation expense related to options which have fully
vested.
For the quarter ended September 30,
2017 the Company reported a net loss of $8.61 million or $0.23 per share, compared with a net loss of
$10.57 million or $0.29 per share for the comparative quarter in
2016.
Nine Months Financial Results
Research and development expenses for the nine months ended
September 30, 2017 were $19.91 million, decreasing from $23.42 million for the same period in 2016 mainly
due to decreased costs following the closure of our operations in
Israel of $2.50 million and reduced clinical trial
activities.
General and administrative expenses for the nine months ended
September 30, 2017 were $7.63 million, decreasing from $10.18 million for the same period in 2016
primarily due to severance benefits recorded in 2016 related to the
termination of an officer of $1.0
million, and decreased stock-based compensation expense
related to options which have fully vested of $2.0 million.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
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September 30,
2017
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|
|
December 31,
2016
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|
|
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Unaudited
|
|
|
Audited
|
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ASSETS
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|
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|
|
|
|
|
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|
|
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CURRENT
ASSETS:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
14,960
|
|
|
$
|
39,838
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|
Prepaid expenses and
other current assets
|
|
|
954
|
|
|
|
335
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
|
15,914
|
|
|
|
40,173
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|
|
|
|
|
|
|
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|
LONG-TERM
ASSETS:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted lease
deposits
|
|
|
11
|
|
|
|
11
|
|
Property and
equipment, net
|
|
|
97
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|
|
|
377
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|
Other long-term
assets
|
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|
927
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|
|
|
-
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|
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|
|
|
|
|
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Total long-term
assets
|
|
|
1,035
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|
|
|
388
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|
|
|
|
|
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Total
assets
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|
$
|
16,949
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|
|
$
|
40,561
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|
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LIABILITIES AND
STOCKHOLDERS' EQUITY
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CURRENT
LIABILITIES:
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|
|
|
|
|
|
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|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
3,481
|
|
|
$
|
137
|
|
Other accounts
payable and accrued expenses
|
|
|
3,376
|
|
|
|
5,446
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|
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|
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Total current
liabilities
|
|
|
6,857
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|
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|
5,583
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|
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|
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Total
liabilities
|
|
|
6,857
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|
|
|
5,583
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|
|
|
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|
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STOCKHOLDERS'
EQUITY:
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Common stock -
$0.0001 par value; 100,000,000 shares authorized; 37,110,043
shares issued and outstanding at September 30, 2017; 37,112,343
shares issued and 37,103,843 shares outstanding at December 31,
2016
|
|
$
|
4
|
|
|
$
|
4
|
|
Additional paid-in
capital
|
|
|
217,907
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|
|
|
215,008
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Accumulated
deficit
|
|
|
(207,819)
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(180,034)
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Total stockholders'
equity
|
|
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10,092
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|
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34,978
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Total liabilities and
stockholders' equity
|
|
$
|
16,949
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|
|
$
|
40,561
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CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
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Nine months
ended
September 30,
|
|
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Three months
ended
September 30,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
|
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Unaudited
|
|
|
Unaudited
|
|
Research and
development expenses
|
|
$
|
19,913
|
|
|
$
|
23,417
|
|
|
$
|
6,299
|
|
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$
|
7,725
|
|
Less: Participation
by Office of Chief Scientist
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-
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|
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|
(196)
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-
|
|
|
|
(196)
|
|
General and
administrative expenses
|
|
|
7,627
|
|
|
|
10,178
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|
|
|
2,270
|
|
|
|
3,042
|
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Operating
loss
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|
(27,540)
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|
(33,399)
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(8,569)
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|
|
|
(10,571)
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Financial (expense) /
income
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|
|
(15)
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|
|
|
(6)
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|
|
|
(36)
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|
|
14
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|
|
|
|
|
|
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|
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|
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Loss before
taxes
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|
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(27,555)
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(33,405)
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|
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(8,605)
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|
|
|
(10,557)
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|
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|
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Taxes
|
|
|
-
|
|
|
|
16
|
|
|
|
-
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
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Net loss
|
|
$
|
(27,555)
|
|
|
$
|
(33,421)
|
|
|
$
|
(8,605)
|
|
|
$
|
(10,570)
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|
|
|
|
|
|
|
|
|
|
|
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Basic and diluted
loss per share
|
|
$
|
(0.74)
|
|
|
$
|
(0.97)
|
|
|
$
|
(0.23)
|
|
|
$
|
(0.29)
|
|
Weighted average
number of common stock used in computing basic and diluted loss per
share
|
|
|
37,109,455
|
|
|
|
34,510,787
|
|
|
|
37,110,043
|
|
|
|
37,080,789
|
|
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 leverages 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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content:http://www.prnewswire.com/news-releases/aevi-genomic-medicine-reports-third-quarter-2017-financial-results-300548462.html
SOURCE Aevi Genomic Medicine, Inc.