Aevi Genomic Medicine Reports Second Quarter 2018 Financial Results and Provides Business Update
Published: Aug 02, 2018
PHILADELPHIA, Aug. 2, 2018 /PRNewswire/ -- Aevi Genomic Medicine (NASDAQ: GNMX) (the "Company") announced today financial and operational results for the three months ended June 30, 2018 and provided an overview of the Company's recent corporate progress.
Second Quarter Financial Results and Recent Corporate Highlights
"We remain focused on advancing our programs in ADHD and severe pediatric onset Crohn's disease," said Mike Cola, Chief Executive Officer of the Company. "We look forward to sharing data from the ASCEND trial in the fourth quarter of this year, while expanding our efforts to enroll patients into the Phase 1b trial of severe pediatric onset Crohn's disease and working towards preclinical proof-of-concept data for AEVI-005."
Second Quarter 2018 Financial Results
The Company had cash and cash equivalents of $19.2 million at June 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. Based upon current management projections, the Company expects the current cash balance to fund operations into early in the first quarter of 2019.
Research and development expenses for the three months ended June 30, 2018 were $5.8 million, approximately equivalent to $5.7 million for the same period in 2017.
General and administrative expenses for the three months ended June 30, 2018 were $2.5 million, approximately equivalent to $2.4 million for the same period in 2017.
For the three months ended June 30, 2018, the Company reported a net loss of $8.2 million or $0.14 per share, compared with a net loss of $8.0 million or $0.22 per share for the same period in 2017.
CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) June 30, December 31, 2018 2017 ---- ---- Unaudited Audited --------- ------- ASSETS CURRENT ASSETS: Cash and cash equivalents $19,151 $33,729 Prepaid expenses and other current assets 855 893 --- --- Total current assets 20,006 34,622 ------ ------ LONG-TERM ASSETS: Lease deposits 11 11 Property and equipment, net 53 85 Other long-term assets 163 43 --- --- Total long-term assets 227 139 --- --- Total assets $20,233 $34,761 ------- ------- LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Trade payables $1,463 $943 Other accounts payable and accrued expenses 3,480 3,197 ----- ----- Total current liabilities 4,943 4,140 ----- ----- Total liabilities 4,943 4,140 ----- ----- STOCKHOLDERS' EQUITY: Common stock - $0.0001 par value; 200,000,000 shares authorized; 59,340,731 $6 $6 shares issued and outstanding at June 30, 2018; 59,332,265 shares issued and outstanding at December 31, 2017 Additional paid-in capital 247,162 245,593 Accumulated deficit (231,878) (214,978) -------- -------- Total stockholders' equity 15,290 30,621 ------ ------ Total liabilities and stockholders' equity $20,233 $34,761 ------- -------
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share and per share data) Six months ended Three months ended June 30, June 30, -------- -------- 2018 2017 2018 2017 ---- ---- ---- ---- Unaudited Unaudited --------- --------- Research and development expenses $12,308 $13,614 $5,747 $5,667 General and administrative expenses 4,678 5,357 2,504 2,369 ----- ----- ----- ----- Operating loss (16,986) (18,971) (8,251) (8,036) Financial income 86 21 60 3 --- --- --- --- Net loss $(16,900) $(18,950) $(8,191) $(8,033) Basic and diluted loss per share $(0.28) $(0.51) $(0.14) $(0.22) Weighted average number of common 59,336,547 37,109,157 59,338,255 37,110,043 stock used in computing basic and diluted loss per share
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.
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.
Aevi Genomic Medicine 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.
The molecule 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).
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 clinical 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.
Aevi Genomic Medicine, Inc.
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Company Codes: NASDAQ-NMS:GNMX