PHILADELPHIA, Nov. 1, 2018 /PRNewswire/ -- Aevi Genomic Medicine, Inc. (NASDAQ: GNMX) (the "Company") announced today financial and operational results for the three months ended September 30, 2018 and provided an overview of the Company's recent corporate progress.
Third Quarter Financial Results and Recent Corporate Highlights
- AEVI-001 ASCEND clinical trial update: In October 2018, the Company announced that it completed enrollment for the ASCEND trial, a genomically-guided Phase 2 study of AEVI-001, a novel, non-stimulant therapy in pediatric and adolescent patients with Attention Deficit Hyperactivity Disorder (ADHD). Part A of the trial is studying a mGluR mutation positive genetic subset of pediatric and adolescent ADHD patients. Part B of the trial is studying pediatric and adolescents ADHD patients without mGluR mutations. Individual and pooled analysis of Parts A and B will be conducted simultaneously and will inform the design of the planned Phase 3 development program in ADHD, expected to utilize AEVI-004, a co-crystal version of AEVI-001. The Company currently anticipates announcing top-line data for both Parts A and B in January 2019.
- AEVI-004, co-crystal version of AEVI-001: AEVI-004 is a new chemical entity (NCE) co-crystal of AEVI-001 that has comparatively greater stability and a higher melting point than AEVI-001, while being engineered to maintain substantially similar solubility, dissolution and pharmacokinetics. AEVI-004 is expected to provide composition of matter patent protection through 2039 with the potential to broaden the applicability of the program beyond ADHD into other neuropsychiatric diseases. The U.S. Food and Drug Administration (FDA) has 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 studies with limited impact on the program timeline.
- AEVI-002 enrollment update: Increased patient screening at multiple clinical trial sites in the United States continues for the Company's Phase 1b open-label, signal-finding trial to 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-TNFa) treatment. Expanding the number of clinical trial sites has led to increased screening activity, but the Company has not yet enrolled any patients into this trial. Assuming a small number of patients can be enrolled by the end of the first quarter 2019, initial data is expected by mid-year 2019.
- AEVI-005: The Company initiated a preclinical research program for AEVI-005, the second monoclonal antibody in development as part of the Company's ongoing collaboration with Kyowa Hakko Kirin, during the second quarter of 2018. AEVI-005 is being studied in an undisclosed ultra-orphan auto-immune pediatric disease.
"It has been a productive quarter for Aevi," said Mike Cola, Chief Executive Officer of the Company. "We were able to successfully utilize our ATM facility to bring in approximately $5.0 million in capital which has allowed us to move forward in our programs. Completing enrollment in Parts A and B of the ASCEND trial was an important milestone for the Company, and we look forward to sharing data from the trial in January 2019. In addition to progress with AEVI-001, we are developing AEVI-004 as a follow-on to AEVI-001 in ADHD and potentially other adjacent neuropsychiatric indications and are making progress in our preclinical work on AEVI-005."
Third Quarter 2018 Financial Results
The Company had cash and cash equivalents of $19.6 million at September 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.
For the quarter ended September 30, 2018, the Company sold 5,426,151 shares of common stock under its ATM Facility for net proceeds of $5.0 million.
Based upon current management projections, the Company expects the current cash balance to fund operations into the first quarter of 2019.
Research and development expenses for the three months ended September 30, 2018 were $5.1 million, decreasing from $6.3 million for the same period in 2017 mainly related to decreased clinical development and research activities.
General and administrative expenses for the three months ended September 30, 2018 were $2.2 million, approximately equivalent to $2.3 million for the same period in 2017.
For the three months ended September 30, 2018, the Company reported a net loss of $7.2 million or $0.12 per share, compared with a net loss of $8.6 million or $0.23 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.
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.
The Company 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.
AEVI-004 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 clinica 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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