Homology Medicines Announces Closing of Deal Leveraging its Internal Process Development and CMC Capabilities Through Newly Formed AAV Manufacturing Innovation Business with Oxford Biomedica
March 10 2022 - 4:01PM
Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines
company, announced today the successful closing of the deal with
Oxford Biomedica plc (LSE: OXB) to establish an Adeno-Associated
Virus (AAV) Manufacturing and Innovation Business. The new company,
Oxford Biomedica Solutions LLC, incorporates Homology’s technical
and manufacturing operations, team and GMP facility with OXB’s
extensive know-how in viral vector manufacturing. Homology will
maintain access to the capabilities that the Company built over the
past four years, as well as share in potential benefits derived
from future innovations as a 20% owner and preferred customer of
Oxford Biomedica Solutions.
“As we move our clinical programs and pipeline forward,
high-quality manufacturing from an industry-leading team remains
one of our most important priorities,” said Arthur Tzianabos,
Ph.D., President and Chief Executive Officer of Homology Medicines.
“Our stake in Oxford Biomedica Solutions provides us with continued
access to experts in our AAVHSC technology platform with the added
benefits that our partnership with global viral vector
manufacturing leader OXB can bring. In addition, the $130 million
in non-dilutive capital will be instrumental in advancing our own
programs, while we work with OXB to build what we believe will be a
highly successful business offering to many companies seeking
high-quality AAV products that patients deserve. We look forward to
our continued work with Tim Kelly, who served as Homology’s Chief
Operating Officer and built our internal manufacturing
capabilities, as he assumes the CEO and Board Chair positions at
Oxford Biomedica Solutions.”
In connection with Homology’s contribution of its AAV process
development and manufacturing assets, including AAV experts, GMP
operations and manufacturing facility to Oxford Biomedica
Solutions, Homology received $130 million from OXB. Homology
believes that this non-dilutive capital, together with a reduction
in operating expenses relating to manufacturing, will extend the
Company’s cash runway into the second half of 2024. Additionally,
there is an opportunity for Homology to receive further
non-dilutive funding at any time following the three-year
anniversary of the agreement, which could result from the exercise
of options related to OXB’s potential purchase of Homology’s
ownership interest in Oxford Biomedica Solutions. MTS Health
Partners served as financial advisor to Homology on the deal, and
Latham and Watkins, LLP served as Homology’s legal advisor.
About Homology Medicines, Inc.Homology
Medicines, Inc. is a clinical-stage genetic medicines company
dedicated to transforming the lives of patients suffering from rare
diseases by addressing the underlying cause of the disease.
Homology’s clinical programs include HMI-102, an investigational
gene therapy for adults with phenylketonuria (PKU); HMI-103, a gene
editing candidate for PKU; and HMI-203, an investigational gene
therapy for Hunter syndrome. Additional programs focus on
metachromatic leukodystrophy (MLD), paroxysmal nocturnal
hemoglobinuria (PNH) and other diseases. Homology’s proprietary
platform is designed to utilize its family of 15 human
hematopoietic stem cell-derived adeno-associated virus vectors
(AAVHSCs) to precisely and efficiently deliver genetic medicines in
vivo through a gene therapy or nuclease-free gene editing modality,
as well as to deliver one-time gene therapy to produce antibodies
throughout the body through the GTx-mAb platform. Homology has a
management team with a successful track record of discovering,
developing and commercializing therapeutics with a focus on rare
diseases. Homology believes its initial clinical data and
compelling preclinical data, scientific and product development
expertise, and broad intellectual property position Homology as a
leader in genetic medicines. For more information, visit
www.homologymedicines.com.
Forward-Looking Statements This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including, without limitation, statements regarding our
expectations regarding the transaction described above, including
anticipated benefits, anticipated payments, future business and
market opportunities, and anticipated growth resulting from the
transaction; the potential, safety, efficacy, and regulatory and
clinical progress of our product candidates; our position as a
leader in the development of genetic medicines; and the sufficiency
of our cash and cash equivalents to fund our operations; These
statements are neither promises nor guarantees, but involve known
and unknown risks, uncertainties and other important factors that
may cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the following: we may
not realize the anticipated benefits of the collaboration
with Oxford Biomedica; the impact of the COVID-19 pandemic on
our business and operations, including our preclinical studies and
clinical trials, and on general economic conditions; we have and
expect to continue to incur significant losses; our need for
additional funding, which may not be available; failure to identify
additional product candidates and develop or commercialize
marketable products; the early stage of our development efforts;
potential unforeseen events during clinical trials could cause
delays or other adverse consequences; risks relating to the
regulatory approval process; our product candidates may cause
serious adverse side effects; inability to maintain our
collaborations, or the failure of these collaborations; our
reliance on third parties; failure to obtain U.S. or
international marketing approval; ongoing regulatory obligations;
effects of significant competition; unfavorable pricing
regulations, third-party reimbursement practices or healthcare
reform initiatives; product liability lawsuits; failure to attract,
retain and motivate qualified personnel; the possibility of system
failures or security breaches; risks relating to intellectual
property and significant costs as a result of operating as a public
company. These and other important factors discussed under the
caption “Risk Factors” in our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2021 and our other filings
with the Securities and Exchange Commission (“the SEC”)
could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management’s
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, we disclaim any obligation to do so, even if subsequent
events cause our views to change.
Company ContactsTheresa McNeelyChief
Communications Officer and Patient
Advocatetmcneely@homologymedicines.com781-301-7277
Media Contact:Cara Mayfield Vice President,
Patient Advocacy and Corporate Communications
cmayfield@homologymedicines.com 781-691-3510
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