PHILADELPHIA, Dec. 5, 2019 /PRNewswire/ -- Aevi Genomic
Medicine, Inc. ("Aevi") (Nasdaq: GNMX) today announced that it
entered into a definitive merger agreement with Cerecor, Inc.
("Cerecor") (Nasdaq: CERC) pursuant to which Aevi will merge with a
wholly owned subsidiary of Cerecor in an all-stock transaction (the
"Merger") valued at approximately $16.1
million at closing, plus contingent value rights, or
CVRs, for up to an additional $6.5
million in subsequent milestone payments on clinical or
regulatory successes, or both. Following closing, the combined
bio-pharmaceutical company will continue to be focused on pediatric
orphan diseases and operate under the name Cerecor. Michael
F. Cola will become Chief Executive Officer and Garry Neil will become Chief Medical Officer, of
the combined company.
Deal Components
- Cerecor will acquire all outstanding shares of Aevi stock at an
aggregate purchase price of $16.1
million less an amount by which Aevi's net assets at closing
are less than negative $1.3 million,
but in no event will such adjustment be more than $500,000. The per share price will be based
on the number of Aevi shares outstanding immediately prior to
closing, including the shares of Aevi stock to be issued to
Children's Hospital of Philadelphia Foundation upon conversion of
its outstanding secured promissory note and to AstraZeneca in
connection with the exercise by Aevi of its license option for
MEDI2338, which, is anticipated to result in an approximate per
share value of $0.134 to Aevi
stockholders, assuming the maximum net asset related
adjustment.
- Cerecor will issue contingent value rights to former Aevi
stockholders, which would entitle them to an additional
$2 million in cash or stock (at
Cerecor's discretion) upon the enrollment of a patient in a Phase
II study related to the AEVI-002, AEVI-006 or AEVI-007 within 24
months of closing.
- The contingent value rights also entitle former Aevi
stockholders to an additional $4.5
million in cash or stock (at Cerecor's discretion) upon Food
and Drug Administration (FDA) approval of a New Drug Application
(NDA) for AEVI-007 (MEDI2338) or AEVI-006 (OSI-027) within 60
months of closing.
Benefits of the Transaction
- Value creation through pipeline assets: The
integration of Aevi's pipeline programs should enhance the Cerecor
pipeline and broaden an already rich set of near-term inflection
points for Cerecor's rare disease portfolio, which includes the
CERC-800s. Aevi's clinical-stage programs have the potential
to benefit a variety of patient populations with significant unmet
needs. Additionally, one or more of Aevi's programs may have
the potential to be eligible for a Priority Review Voucher (PRV)
granted by the FDA associated with Rare Pediatric Disease (RPD)
Designation. FDA will award priority review vouchers to
sponsors of rare pediatric disease product applications that meet
certain criteria. Under this program, a sponsor who receives an
approval for a drug or biologic for a "rare pediatric disease"
(RPD) may qualify for a voucher that can be redeemed to receive a
priority review of a subsequent marketing application for a
different product.
-
- 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; patients with AOSD and
MM show elevated levels of IL-18. Cerecor seeks to initiate a Phase
1b/2a proof-of-concept study of
AEVI-007 in ASOD and MM patients in 2020.
- AEVI-006 is an mTORC1/2 inhibitor (a class of drugs that
inhibit the mammalian target of
rapamycin) targeted towards Complex Lymphatic
Malformations (LM). LM patients often have activating
mutations along the PI3K/AKT/mTOR pathway and sirolimus is an
mTORC1 inhibitor that has demonstrated clinical utility in LM.
AEVI-006 has the potential to improve on both the safety and
efficacy of mTOR inhibition in LM. Cerecor seeks to initiate a
Phase 1b/2a proof-of-concept study of
AEVI-006 in LM patients in 2020.
- 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 Crohn's Disease. AEVI-002 is currently in a Phase I study
in adult Crohn's patients and has recently dosed the first patient.
Cerecor anticipates initial data in the first half of 2020.
- Aligns with Cerecor's and Aevi's transformation and
innovation strategies: Cerecor's pipeline strategy is
focused on developing new medicines for rare and orphan diseases
and Aevi is focused on developing novel therapies primarily for
pediatric onset, life-altering diseases, including rare and orphan
diseases. Aevi's pipeline programs complement Cerecor's
existing pediatric rare disease pipeline 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. The FDA has granted RPD Designation and
Orphan Drug Designation ("ODD") to all three CERC-800 compounds,
thus qualifying Cerecor to receive a PRV upon approval of an
NDA.
About the Transaction
The boards of directors of both Aevi and Cerecor have approved
the proposed transaction. The consummation of the Merger is
subject to customary closing conditions, including the stockholders
of Aevi approving the Merger and the Securities and Exchange
Commission declaring effective the registration statement on which
the shares of Cerecor common stock issued in the merger will be
registered. The merger is expected to close during the first
quarter of 2020.
Wedbush PacGrow is acting as the exclusive strategic advisor to
Aevi and Pepper Hamilton LLP is serving as its legal counsel.
Wyrick Robbins Yates & Ponton
LLP is serving as Cerecor's legal counsel.
About Aevi:
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, Aevi's research and development
efforts include working with the Center for Applied
Genomics (CAG) at Children's
Hospital of Philadelphia to leverage novel genetic
discoveries to progress its genomic medicine strategy.
About Cerecor:
Cerecor is a biopharmaceutical company focused on becoming a
leader in development and commercialization of treatments for rare
and orphan diseases and neurological conditions. Cerecor is
building a robust pipeline of innovative therapies in orphan
diseases and neurology. Cerecor'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. The FDA granted Rare Pediatric Disease
Designation and Orphan Drug Designation ("ODD") to all three
CERC-800 compounds, thus qualifying Cerecor to receive a Priority
Review Voucher ("PRV") upon approval of a new drug application
("NDA"). The PRV may be sold or transferred an unlimited number of
times. Cerecor plans to leverage the 505(b)(2) NDA pathway for
all three compounds to accelerate development and
approval. Cerecor is also developing one other preclinical
pediatric orphan rare disease compound, CERC-913, for the treatment
of mitochondrial DNA Depletion Syndrome. Cerecor's neurology
pipeline is led by CERC-301, a Glutamate NR2B selective, NMDA
Receptor antagonist, which Cerecor is currently exploring as a
novel treatment for orthostatic hypotension. Cerecor is also
developing CERC-406, a CNS-targeted COMT inhibitor for Parkinson's
Disease. Cerecor also has one marketed product, Millipred®, an oral
prednisolone indicated across a wide variety of inflammatory
conditions and indications.
Cautionary Note Regarding Forward-Looking Statements
This press 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,
including, but not limited to, Aevi's and Cerecor's expectations or
predictions of future financial or business performance or
conditions. 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.
These forward-looking statements are subject to numerous
assumptions, risks and uncertainties, which change over time, are
difficult to predict and are generally beyond the control of either
company. Actual results may differ materially from current
projections.
Important factors that may cause actual results to differ
materially from the results discussed in the forward-looking
statements or historical experience include risks and
uncertainties, including the timing and completion of the Merger,
the parties' ability to satisfy the closing conditions of the
merger agreement, the failure by Aevi or Cerecor to secure and
maintain relationships with collaborators and/or investors; risks
relating to clinical trials; risks relating to the
commercialization, if any, of Aevi's or Cerecor's proposed product
candidates (such as marketing, regulatory, product liability,
supply, competition, and other risks); dependence on the efforts of
third parties; dependence on intellectual property; and risks that
Aevi or Cerecor may lack the financial resources and access to
capital to fund proposed operations. Further information on the
factors and risks that could affect Aevi's and Cerecor's respective
businesses, financial conditions and results of operations are
contained in Aevi's and Cerecor's filings with the U.S. Securities
and Exchange Commission, or SEC, which are available at
www.sec.gov. The forward-looking statements represent Aevi's and
Cerecor's estimate as of the date hereof only, and Aevi and Cerecor
specifically disclaim any duty or obligation to update
forward-looking statements.
Important Information and Where to Find It
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities of Aevi or Cerecor
or the solicitation of any vote or approval. In connection with the
proposed transaction, Cerecor will file with the SEC a Registration
Statement on Form S-4 containing a proxy statement/prospectus.
The proxy statement/prospectus will contain important information
about Aevi, Cerecor, the transaction and related matters. Aevi will
mail or otherwise deliver the proxy statement/prospectus to its
stockholders when it becomes available. Investors and security
holders of Aevi and Cerecor are urged to read carefully the proxy
statement/prospectus relating to the merger (including any
amendments or supplements thereto) in its entirety when it is
available, because it will contain important information about the
proposed transaction.
Investors and security holders of Aevi and Cerecor will be able
to obtain free copies of the proxy statement/prospectus for the
proposed merger (when it is available) and other documents filed
with the SEC by Aevi and Cerecor through the website maintained by
the SEC at www.sec.gov. In addition, investors and security holders
of Aevi will be able to obtain free copies of the proxy
statement/prospectus for the proposed merger (when it is available)
by contacting Aevi, Attn: Mike
McInaw, michael.mcinaw@aevigenomics.com. Investors and
security holders of Cerecor will be able to obtain free copies of
the proxy statement/prospectus for the merger by contacting
Cerecor, Attn: James Harrell, jharrell@cerecor.com.
Aevi and Cerecor, and their respective directors and certain of
their executive officers, may be deemed to be participants in the
solicitation of proxies in respect of the transactions contemplated
by the agreement between Aevi and Cerecor. Information regarding
Aevi's directors and executive officers is contained in Aevi's
Annual Report on Form 10-K for the fiscal year ended
December 31, 2018, which was filed with the SEC on
March 29, 2019, and will also be available in the proxy
statement/prospectus that will be filed by Cerecor with the SEC in
connection with the proposed transaction. Information regarding
Cerecor's directors and executive officers is contained in
Cerecor's Annual Report on Form 10-K for the fiscal year ended
December 31, 2018, which was filed with the SEC on
March 18, 2019, and will also be available in the proxy
statement/prospectus that will be filed by Cerecor with the SEC in
connection with the proposed transaction.
CONTACTS:
For Aevi Genomic Medicine, Inc.
Mike Cola
Mike.cola@aevigenomics.com
Westwicke Partners
Chris
Brinzey
+1-339-970-2843
Chris.brinzey@westwicke.com
MEDIA INQUIRIES:
FTI Consulting
Irma
Gomez-Dib
+1-212-850-5761
+1-415-706-9155
irma.gomez-dib@fticonsulting.com
For Cerecor Inc.
For Media and Investor Inquiries
James Harrell,
Chief Commercial Officer
Cerecor Inc.
jharrell@cerecor.com
623.439.2220 office
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SOURCE Aevi Genomic Medicine, Inc.