Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on
becoming a leader in development and commercialization of
treatments for rare pediatric and orphan diseases, announced today
it has completed the previously announced acquisition of Aevi
Genomic Medicine (NASDAQ: GNMX) in an all-stock transaction valued
at approximately $15.6 million at close, plus contingent value
rights (CVRs) for up to an additional $6.5 million in subsequent
payments based on clinical and/or regulatory milestones. Cerecor’s
pipeline now includes six clinical-stage assets, accelerating the
Company’s transformation into a research and development
organization focused on developing new medicines for unmet needs in
rare diseases, particularly for pediatric patients. The Company
continues to explore strategic alternatives for its non-core
neurological assets, including CERC-301, as well as its sole
commercialized product, Millipred®.
Mike Cola, Chief Executive Officer, Cerecor, stated, “Cerecor
began this transformation roughly 15 months ago with the
acquisition of the CERC-800s, which have the potential to be the
first-ever approved treatments for Congenital Disorders of
Glycosylation (CDGs). Following the more recent divestiture of the
majority of the commercial pediatric portfolio and the acquisition
of Aevi, today the Company is proud to advance a robust pipeline of
six clinical-stage rare disease programs with the potential to be
first-in-class medicines addressing high unmet needs of patients
and families. Four of these programs are potentially
Priority Review Voucher (PRV) eligible, with three already granted
Rare Pediatric Disease Designation (RPDD) by the FDA. Cerecor
is focused on achieving several critical inflection points
throughout 2020, including initiation of pivotal studies for one or
more CERC-800 program(s) and clinical proof-of-concept studies in
patients with the recently integrated Aevi assets: CERC-002,
CERC-006 and CERC-007. We believe this combination of assets
present a unique opportunity to efficiently deliver high impact
medicines by leveraging biomarker-driven approaches in clinical
development”.
Pipeline Assets Accelerate Company
Transformation
- Commitment to Rare Pediatric and Orphan
Diseases: Cerecor continues its commitment to
becoming an R&D-focused biopharmaceutical company with a robust
pipeline of rare pediatric and orphan disease programs. This
transaction expands the number of clinical programs in development
at Cerecor while creating depth of focus in rare pediatric and
orphan diseases.
- Pipeline Assets: The emerging
clinical-stage pipeline consists of six medicines with compelling
biological rationale in orphan autoimmune, metabolic and oncology
indications, with the potential for multiple product launches
through 2023:
-
- CERC-002 (formerly AEVI-002), a fully-human, anti-LIGHT
monoclonal antibody for Pediatric Onset Crohn’s Disease
- CERC-006 (formerly AEVI-006), a potent, orally-available
mTORC1/2 inhibitor for complex Lymphatic Malformations
- CERC-007 (formerly AEVI-007), a fully-human, anti-IL-18
monoclonal antibody for auto-inflammatory diseases, including Adult
Onset Still’s Disease (AOSD) and Multiple Myeloma)
- CERC-801, an ultra-pure, D-Galactose substrate replacement
therapy for PGM1-CDG
- CERC-802, an ultra-pure, D-Mannose substrate replacement
therapy for MPI-CDG
- CERC-803, an ultra-pure, L-Fucose substrate replacement therapy
for SLC35C1-CDG
Details of the Transaction
For details of the transaction please see the Investor Relations
section of Cerecor.com. www.cerecor.com
New Officers Appointed
Michael Cola has been appointed as the Chief Executive Officer
and Dr. Garry Neil has been appointed as the Chief Medical Officer
of Cerecor.
Mr. Cola brings a wealth of leadership experience in the
biopharmaceutical industry. Prior to joining Cerecor, Mr.
Cola served as President and CEO of Aevi Genomic Medicine since
September 2013. Prior to joining Aevi Genomic Medicine, Mr. Cola
served as President of Specialty Pharmaceuticals at Shire plc, a
global specialty pharmaceutical company, from 2007 until April
2012. He joined Shire in 2005 as EVP of Global Therapeutic Business
Units and Portfolio Management. Prior to joining Shire, he was with
Safeguard Scientifics, Inc., a growth capital provider to life
sciences and technology companies, where he served as President of
the Life Sciences Group. While at Safeguard, Mr. Cola served as
Chairman and CEO of Clarient, Inc., a cancer diagnostics company
subsequently acquired by GE Healthcare, and as Chairman of Laureate
Pharma, Inc., Prior to Safeguard Scientifics, Mr. Cola held senior
positions in product development and commercialization at Astra
Merck, a top 20 U.S. pharmaceutical company, and at Astra Zeneca, a
global biopharmaceutical company. Mr. Cola received a B.A. in
biology and physics from Ursinus College and an M.S. in biomedical
science from Drexel University. He serves on the Board of Directors
of Vanda Pharmaceuticals Inc., Sage Therapeutics and Phathom
Pharmaceuticals, and currently serves as Chairman of the Board of
Governors of the Boys & Girls Clubs of Philadelphia.
Prior to becoming the Chief Medical Officer at Cerecor, Dr.
Garry Neil served as Chief Scientific Officer of Aevi Genomic
Medicine since September 2013. Prior to joining Aevi Genomic
Medicine, Dr. Neil held a number of senior positions in the
pharmaceutical industry, academia and venture capital. These
include Corporate VP of Science & Technology at Johnson &
Johnson, and Group President at Johnson & Johnson
Pharmaceutical Research and Development, VP of R&D at Merck
KGaA/EMD Pharmaceuticals, VP of Clinical Research at Astra Zeneca
and Astra Merck. Dr. Neil holds a B.S. from the University of
Saskatchewan and an M.D. from the University of Saskatchewan
College of Medicine. He completed his postdoctoral clinical
training in internal medicine and gastroenterology at the
University of Toronto. Dr. Neil also completed a postdoctoral
research fellowship at the Research Institute of Scripps Clinic. He
is the Founding Chairman of the Pharmaceutical Industry R&D
Consortium, TransCelerate Biopharmaceuticals Inc. He also
serves on the Boards of Arena Pharmaceuticals, the Reagan Udall
Foundation and the Center for Discovery and Innovation at
Hackensack Meridian Health. He is past Chairman of the
Pharmaceutical Research and Manufacturers Association (PhRMA)
Science and Regulatory Executive Committee and the PhRMA Foundation
Board. He is a past member of the Boards of GTx
Pharmaceuticals, the Foundation for the National Institutes of
Health (FNIH), and the Science Management Review Board of the
NIH.
Additionally, Mr. Cola and Dr. Sol J. Barer will be joining the
Board of Directors during the first quarter of 2020. Dr.
Barer’s long career as a senior pharmaceutical executive with
leadership roles in various biopharmaceutical companies, coupled
with his experience and knowledge of the global pharmaceutical
industry and extensive scientific expertise will be a valuable
addition to the Cerecor Board of Directors.
The independent directors of the Board approved,
pursuant to NASDAQ Listing Rule 5635(c)(4), the grant of inducement
equity awards in the form of stock options to Mr. Cola to purchase
1.2 million shares of common stock, to Dr. Neil to purchase 800,000
shares of common stock and to Dr. Jeffery Wilkins, our new Chief
Development Officer, to purchase 375,000 shares of common
stock. Each inducement option grant will vest over four
years, with the first 25% of such option vesting on the first
anniversary of the date of grant, and the remainder vesting in
equal monthly installments, subject to the continued service of Mr.
Cola, Dr. Neil, or Dr. Wilkins respectively, through the applicable
vesting date.
Dr. Simon Pedder, Cerecor’s Executive Chairman
of the Board, added, “We are extremely pleased to complete this
acquisition. We welcome Mike and Garry to Cerecor’s
management team and Dr. Barer to our Board of Directors. The
combined pipeline and leadership team create an exciting platform
for the Company to solidify itself as a leader in rare pediatric
and orphan drug development. The team is focused on executing
and advancing the pipeline to near-term inflection points
throughout 2020 that can set the stage for multiple drug approvals
in the years to come, starting as soon as 2021.”
About CERC-002
CERC-002 (formerly AEVI-002) is an anti-LIGHT
(Lymphotoxin-like, exhibits
Inducible expression, and competes with HSV
Glycoprotein D for HVEM, a
receptor expressed by T lymphocytes (part of the
Tumor Necrosis Super Family 14)), fully human, monoclonal antibody
being developed as a treatment for Pediatric Onset Crohn’s Disease.
CERC-002 is currently in a Phase I trial in adult Crohn’s patients
and has recently dosed the first patient, we anticipate initial
data in the first half of 2020.
About CERC-006
CERC-006 (formerly AEVI-006) is an mTORC1/2 inhibitor (a class
of drugs that inhibit the mammalian
target of
rapamycin) being developed as a
treatment for complex Lymphatic Malformations (LM). LM patients
often have activating mutations along the PI3K/AKT/mTOR pathway;
sirolimus, an mTORC1 inhibitor, has demonstrated clinical utility
in LM. CERC-006 has the potential to improve upon both the safety
and efficacy of mTOR inhibition in LM. Cerecor seeks to initiate a
Phase 1b/2a proof-of-concept study of CERC-006 in LM patients by
the end of 2020.
About CERC-007
CERC-007 (formerly AEVI-007) is a fully human, anti-IL-18
monoclonal antibody with the potential to address multiple
auto-inflammatory diseases, including Adult Onset Stills Disease
(AOSD) and Multiple Myeloma (MM). IL-18 is a pro-inflammatory
cytokine that stimulates the production of interferon gamma;
patients with ASOD and MM show elevated serum levels of IL-18.
Cerecor seeks to initiate two separate Phase 1b/2a proof-of-concept
studies in ASOD and MM patients in the second half of 2020.
About CERC-800s
CERC-801, CERC-802 and CERC-803 are monosaccharide substrate
replacement therapies with known therapeutic utility for the
treatment of Congenital Disorders of Glycosylation. Oral
administration of these substrates replenishes critical metabolic
intermediates that are reduced or absent due to genetic mutation,
overcoming single enzyme defects to support glycoprotein synthesis,
maintenance and function. The FDA has granted RPDD and Orphan Drug
Designation (ODD) to all three CERC-800 programs. CERC-801 and
CERC-802 have completed phase 1 studies and the IND filing for
CERC-803 is anticipated in the first half of 2020. The Company has
an ongoing retrospective study, CDG FIRST, which seeks to collect
natural history and treatment-related data for patients diagnosed
with PGM1-CDG, MPI-CDG or SLC35C1-CDG who are either treated with
or without D-galactose, D-mannose and L-fucose, respectively, as
well as patients with other CDGs who are treated with one of the
three monosaccharides. Cerecor seeks to initiate a pivotal study
for one or more CERC-800 program(s) in 2020, with the first
anticipated NDA filing in 2021.
About Cerecor
Cerecor is a biopharmaceutical company focused on becoming a
leader in development and commercialization of treatments for rare
pediatric and orphan diseases. The Company is advancing an emerging
clinical-stage pipeline of innovative therapies. The
Company’s pediatric rare disease pipeline is led by CERC-801,
CERC-802 and CERC-803 (“CERC-800 programs”), which are therapies
for inborn errors of metabolism, specifically disorders known as
Congenital Disorders of Glycosylation (CDGs). The FDA granted
Rare Pediatric Disease Designation and Orphan Drug Designation
(“ODD”) to all three CERC-800 compounds, thus qualifying the
Company to receive a Priority Review Voucher (“PRV”) upon approval
of a new drug application (“NDA”). The Company plans to leverage
the 505(b)(2) NDA pathway for all three compounds to accelerate
development and approval. The Company is also developing
CERC-002, CERC-006 and CERC-007. CERC-007 is an anti-IL-18
monoclonal antibody being developed for autoimmune inflammatory
diseases such as Adult Onset Stills Disease (AOSD) and Multiple
Myeloma, with initial proof-of-concept in patients expected in
2021. CERC-006 is an mTORC1/2 inhibitor targeted towards
complex Lymphatic Malformations, also with initial proof-of-concept
in patients expected in 2021. CERC-002 is an anti-LIGHT monoclonal
antibody currently in a Phase 1 clinical trial; initial
proof-of-concept data is expected in the first half of 2020 in
Adult Crohn’s Disease, an FDA requirement before proceeding into
Pediatric Onset Crohn’s. The Company is also developing one
other preclinical pediatric orphan rare disease compound, CERC-913,
for the treatment of mitochondrial DNA Depletion Syndrome.
For more information about Cerecor, please visit
www.cerecor.com.
Forward-Looking Statements
This press release may include forward-looking statements made
pursuant to the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are statements that are not historical
facts. Such forward-looking statements are subject to significant
risks and uncertainties that are subject to change based on various
factors (many of which are beyond Cerecor’s control), which could
cause actual results to differ from the forward-looking statements.
Such statements may include, without limitation, statements with
respect to Aevi’s or Cerecor’s plans, objectives, projections,
expectations and intentions and other statements identified by
words such as “projects,” “may,” “will,” “could,” “would,”
“should,” “continue,” “seeks,” “aims,” “predicts,” “believes,”
“expects,” “anticipates,” “estimates,” “intends,” “plans,”
“potential,” or similar expressions (including their use in the
negative), or by discussions of future matters such as: the
integration of the companies and their personnel; the development
of product candidates or products; timing and success of trial
results and regulatory review; potential attributes and benefits of
product candidates; the expansion of Cerecor’s drug portfolio;
strategic alternatives for the neurological assets and Millipred;
and other statements that are not historical. These statements are
based upon the current beliefs and expectations of Cerecor’s
management but are subject to significant risks and uncertainties,
including: risks related to integration of the combined
company; drug development costs, timing and other risks, including
reliance on investigators and enrollment of patients in clinical
trials; regulatory risks; reliance on and the need to attract,
integrate and retain key personnel, including Mr. Cola and Dr.
Neil; Cerecor’s cash position and the need for it to raise
additional capital; risks related to potential strategic
alternatives for the Company’s neurology assets and Millipred; and
those other risks detailed in Aevi’s and Cerecor’s filings with the
Securities and Exchange Commission. Actual results may differ from
those set forth in the forward-looking statements. Except as
required by applicable law, Cerecor expressly disclaims any
obligations or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Cerecor’s expectations with respect thereto
or any change in events, conditions or circumstances on which any
statement is based.
For Media and Investor InquiriesJames Harrell,
Chief Commercial OfficerCerecor
Inc.jharrell@cerecor.com623.439.2220 office
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