PHILADELPHIA, Nov. 2, 2017 /PRNewswire/ -- Aevi Genomic Medicine, Inc. 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 |
||||||||
|
September 30, |
December 31, |
|||||||
|
Unaudited |
Audited |
|||||||
|
ASSETS |
||||||||
|
CURRENT ASSETS: |
||||||||
|
Cash and cash equivalents |
$ |
14,960 |
$ |
39,838 |
||||
|
Prepaid expenses and other current assets |
954 |
335 |
||||||
|
Total current assets |
15,914 |
40,173 |
||||||
|
LONG-TERM ASSETS: |
||||||||
|
Restricted lease deposits |
11 |
11 |
||||||
|
Property and equipment, net |
97 |
377 |
||||||
|
Other long-term assets |
927 |
- |
||||||
|
Total long-term assets |
1,035 |
388 |
||||||
|
Total assets |
$ |
16,949 |
$ |
40,561 |
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||
|
CURRENT LIABILITIES: |
||||||||
|
Trade payables |
$ |
3,481 |
$ |
137 |
||||
|
Other accounts payable and accrued expenses |
3,376 |
5,446 |
||||||
|
Total current liabilities |
6,857 |
5,583 |
||||||
|
Total liabilities |
6,857 |
5,583 |
||||||
|
STOCKHOLDERS' EQUITY: |
||||||||
|
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 |
215,008 |
||||||
|
Accumulated deficit |
(207,819) |
(180,034) |
||||||
|
Total stockholders' equity |
10,092 |
34,978 |
||||||
|
Total liabilities and stockholders' equity |
$ |
16,949 |
$ |
40,561 |
||||
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
|
Nine months ended |
Three months ended |
|||||||||||||||
|
2017 |
2016 |
2017 |
2016 |
|||||||||||||
|
Unaudited |
Unaudited |
|||||||||||||||
|
Research and development expenses |
$ |
19,913 |
$ |
23,417 |
$ |
6,299 |
$ |
7,725 |
||||||||
|
Less: Participation by Office of Chief Scientist |
- |
(196) |
- |
(196) |
||||||||||||
|
General and administrative expenses |
7,627 |
10,178 |
2,270 |
3,042 |
||||||||||||
|
Operating loss |
(27,540) |
(33,399) |
(8,569) |
(10,571) |
||||||||||||
|
Financial (expense) / income |
(15) |
(6) |
(36) |
14 |
||||||||||||
|
Loss before taxes |
(27,555) |
(33,405) |
(8,605) |
(10,557) |
||||||||||||
|
Taxes |
- |
16 |
- |
13 |
||||||||||||
|
Net loss |
$ |
(27,555) |
$ |
(33,421) |
$ |
(8,605) |
$ |
(10,570) |
||||||||
|
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
View original content:http://www.prnewswire.com/news-releases/aevi-genomic-medicine-reports-third-quarter-2017-financial-results-300548462.html
SOURCE Aevi Genomic Medicine, Inc.
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