Aevi Genomic Medicine Reports Second Quarter 2018 Financial Results and Provides Business Update

PHILADELPHIA, Aug. 2, 2018 /PRNewswire/ -- Aevi Genomic Medicine, Inc. (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

• AEVI-001 ASCEND clinical trial update:  In June 2018 the Company announced that the sample size for Part A of the trial, which is enrolling an 8-gene subset of pediatric and adolescent mGLuR mutation positive ADHD patients, will be increased from 42 to 64 patients. The decision to increase the sample size was made according to a prespecified sample size re-estimation design, which allows an adjustment in the sample size after an interim analysis of the placebo arm to ensure the trial is appropriately powered. The Company anticipates data from Part A of the ASCEND trial in the fourth quarter of 2018. 
  
  
• AEVI-004 Co-crystal version of AEVI-001: During the second quarter of 2018 the Company announced that it received positive feedback from the U.S. Food and Drug Administration (FDA) on an improved version of AEVI-001 (AEVI-004).  AEVI-004 is a co-crystal of fasoracetam with a higher melting point and greater stability characteristics which has been engineered to maintain solubility, dissolution and pharmacokinetics substantially similar to AEVI-001, and composition of matter patents are expected through 2039. The Company has received feedback from the FDA provisionally indicating that AEVI-004 is a co-crystal of AEVI-001 and a novel drug substance. The FDA also provisionally indicated that existing toxicology and pathology studies can support clinical development with AEVI-004. Assuming positive results from the ongoing Phase 2 ASCEND clinical trial, and following minimal bridging preclinical and clinical pharmacological studies requested by FDA, the Company anticipates progressing the molecule directly into Phase 3 clinical studies.  
  
  
• AEVI-002:  Patient screening at multiple clinical trial sites in the United States continues for the Company's Phase 1b open-label, signal-finding trial which will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of the Anti-Light Monoclonal Antibody (AEVI-002) in severe pediatric onset Crohn's disease patients that have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.  The Company has not yet enrolled any patients into this trial.  To address the continued enrollment challenges for this program, the Company is evaluating the addition of clinical trial sites outside the United States.  Assuming a small number of patients can be enrolled by the end of the third quarter 2018, initial data from a small number of patients would be expected by year-end 2018.
  
  
• AEVI-005: The Company initiated a preclinical research program for AEVI-005 during the second quarter.  AEVI-005 is the second monoclonal antibody in development as part of the company's ongoing collaboration with Kyowa Hakko Kirin.  AEVI-005 is being studied in an undisclosed ultra-orphan auto-immune pediatric disease. 

"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.

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.

About AEVI-001

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.

About AEVI-004

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).

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, 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.

CONTACT:

Aevi Genomic Medicine, Inc.
Brian Piper
[email protected]

Westwicke Partners
Chris Brinzey
339-970-2843
[email protected]

MEDIA INQUIRIES:

FTI Consulting
Irma Gomez-Dib
+1212-850-5761
+1-415-706-9155
[email protected]

SOURCE Aevi Genomic Medicine, Inc.