Amicus Therapeutics, Inc. (Nasdaq: FOLD) (“Amicus”) today announced
its intent to launch a next-generation genetic medicine company,
Caritas Therapeutics, Inc., (“Caritas”) through a definitive
business combination agreement pursuant to which the Amicus gene
therapy business will be acquired by ARYA Sciences Acquisition Corp
IV (Nasdaq: ARYD) (“ARYA IV”), a special purpose acquisition
company or SPAC, sponsored by Perceptive Advisors. The transaction
will result in two independent publicly traded companies with
attractive stand-alone investment profiles. Amicus will become the
largest shareholder in Caritas with a ~36% ownership stake
(assuming no redemptions by ARYA’s shareholders) and retain
co-development and commercialization rights to the Fabry and Pompe
gene therapy programs as well as negotiation rights on select
future muscular dystrophy programs.
Upon consummation of the business combination,
current Amicus Chairman and Chief Executive Officer John F. Crowley
will lead Caritas as Chairman and Chief Executive Officer and will
become the Chairman Emeritus and Chief Strategic Advisor for
Amicus. Current Amicus President and Chief Operating Officer
Bradley Campbell will be named as Chief Executive Officer of
Amicus.
“This is a big, bold vision and a massive step
forward for next generation biotechnologies for people worldwide
living with some of the most devastating rare diseases. In a single
stroke with the formation and funding of Caritas we will create
what will be one of the world’s preeminent next-generation genetic
medicines companies. We strongly believe that separating our
business into two highly focused, stand-alone companies is the best
way to unlock significant value for Amicus shareholders and to
advance our medicines and technologies to people living with rare
diseases around the world,” stated John F. Crowley, Chairman and
Chief Executive Officer of Amicus. “This transaction will serve
patients and shareholders well by accelerating funding for our next
generation gene therapy pipeline, and strengthening the financial
profiles of both companies. We are immensely excited for what the
future of science and biotechnology holds as we accelerate and
recommit to our mission.”
"This transaction will transform Amicus into a
premier rare disease global commercialization and late stage
product development company that we believe will benefit all of our
stakeholders," said Bradley Campbell, President and Chief Operating
Officer of Amicus. "The separation strengthens the financial
profile of Amicus and accelerates our path to profitability, while
preserving significant equity ownership in the gene therapy
pipeline and commercial rights to the innovative and important
Fabry and Pompe gene therapy programs. We will be laser focused on
maintaining the growth of Galafold and executing on the anticipated
global launch of AT-GAA, as we build Amicus into a leading global
rare disease biotechnology company and bring our medicines to as
many patients as quickly as possible."
Amicus expects the separation to create value
for all stakeholders and result in material benefits to the
stand-alone companies, including:
- Enhancing the ability of both
companies to meet the unmet needs of many individuals and families
affected by rare diseases,
- Accelerating the development and
broadening the scope of one of the largest rare disease gene
therapy portfolios in the industry,
- Funding the gene therapy next
generation scientific platform technologies as well as
manufacturing capabilities of the new company,
- Strengthening the financial profile
of each company,
- Reinforcing management focus on key
strategic and financial goals,
- Unlocking value while creating a
more targeted investment thesis for shareholders.
Amicus Therapeutics’ focus as a rare
disease global commercialization and late stage development
company
Following the transaction, Amicus will remain a
global, patient-dedicated biotechnology company developing and
delivering novel high-quality medicines for people living with rare
diseases. Amicus’ focus will be to grow its leadership position
across Amicus’ two lead indications of Fabry disease and Pompe
disease. In addition, it is expected the transaction will
strengthen the Amicus financial outlook and enable it to achieve
profitability in 2023.1
Upon completion of the transaction, Amicus will
become the largest shareholder in Caritas and retain co-development
and commercialization rights to the Fabry and Pompe gene therapy
programs, as well as negotiation rights on future muscular
dystrophy programs.
Amicus plans to continue investing in the global
commercialization of Galafold for Fabry disease through geographic
and label expansion, as well as support for diagnostic initiatives.
In Pompe disease, Amicus will focus on securing global approvals,
executing the anticipated global launch of AT-GAA, and providing
access for patients as quickly as possible. Amicus continues to
believe that AT-GAA has the potential upon approval to become the
next standard of care for all people living with Pompe disease.
Amicus also announced today that a syndicate of
leading healthcare biotechnology investors, including Redmile
Group, Avoro Capital Advisors, Perceptive Advisors, Invus, Sphera
Healthcare, and Janus Henderson Investors have agreed to a private
investment in Amicus of approximately $200 million. Amicus expects
to use the net proceeds to further fund initiatives in the global
commercialization of Galafold and the anticipated global launch of
AT-GAA and, in connection with the business combination, to invest
$50 million in cash in Caritas in exchange for additional
equity.
1 Based on projections of Amicus non-GAAP Net
Income under current operating plans, which includes successful
AT-GAA regulatory approvals and continued Galafold growth. We
define non-GAAP Net Income as GAAP Net Income excluding the after
tax impact of share-based compensation expense, changes in fair
value of contingent consideration and depreciation.
Caritas’ focus as a clinical stage, rare
disease discovery and development next-generation genetic medicines
company
The mission of Caritas, the Latin word for
compassion, will be to transform the lives of children and adults
living with rare genetic diseases by harnessing the power of
next-generation genetic medicine and gene therapy technologies
through advanced protein engineering and innovative gene therapy
vector technologies. Through its 60+ bench scientists and
experienced development and leadership teams, Caritas will develop
and advance a series of novel platform technologies to address the
key challenges to the safe and efficient gene transfer necessary
for next-generation gene therapies. These include proprietary
technologies designed to address delivery, safety, durability, and
manufacturability of gene therapies. The gene therapy pipeline is
founded on deep expertise and platform technologies in protein
engineering and rare disease biology, the broad research
collaboration with the Perelman School of Medicine at the
University of Pennsylvania (Penn) for best-in-class gene therapies,
and a new co-development collaboration with Amicus.
The pipeline is led by two Batten disease
programs with clinical proof of concept in CLN6 and CLN3, six
active preclinical programs, including Fabry disease, Pompe
disease, and CDKL5 Deficiency Disorder (CDD), as well as multiple
discovery programs. Caritas will have exclusive, global rights to
gene therapy programs for nearly 50 rare genetic diseases through
its broad collaboration with Dr. Jim Wilson and the Penn team,
including a majority of next-generation lysosomal disease programs
as well as 11 more prevalent rare diseases. Among these are
Angelman Syndrome, Duchenne Muscular Dystrophy, Rett Syndrome,
Myotonic Dystrophy and select other muscular dystrophies. Dr. Jim
Wilson will become a senior scientific and strategic advisor to
Caritas.
Amicus management expects that, as a new,
independent entity with approximately 115 employees, Caritas will
be better positioned to pursue its strategic priorities, accelerate
its programs and discovery work, as well as adequately fund its
manufacturing capabilities. Amicus believes that this transaction
will harness those opportunities to the benefit of patients and
shareholders.
“When ARYA IV was formed, our objective was to
identify a company with the potential to successfully address a
significant, unmet need in biomedical science,” said Adam Stone,
Chief Investment Officer of Perceptive Advisors and CEO of ARYA IV.
“Through Caritas, we are combining with a business we believe has
the potential to transform the field of genetic medicine through
advanced protein engineering and innovative vector technologies.
Over the course of our long-standing relationship with Amicus,
we've come to believe in the company’s innovative science and
experienced leadership team. We are excited to see the next phase
of growth for Amicus and Caritas, respectively.”
Caritas Transaction and
TimingAmicus is separating its gene therapy business into
a new entity that will be acquired by ARYA IV, a special purpose
acquisition company or SPAC. At closing of the transaction, ARYA IV
will be named Caritas Therapeutics, Inc. As part of the
transaction, Amicus will receive the following:
- ~36% pro forma ownership in Caritas
(depending on the level of redemptions at ARYA IV)
- Co-development rights and exclusive
global commercialization rights to existing Fabry and Pompe gene
therapies including a 50/50 cost and profit share
- Right of first negotiation to
certain multiple muscular dystrophy programs being developed by
Caritas
Amicus expects to incur charges related to the
transaction during the reporting periods preceding the separation
and does not otherwise expect this to impact Amicus’ financial
guidance for 2021.
In connection with the closing of the
transaction, in addition to its renaming, ARYA IV will redomicile
as a Delaware corporation and its common stock is expected to be
listed on Nasdaq under the ticker symbol “SPES”, the Latin word for
hope.
In addition to the approximately $150 million
held in ARYA IV’s trust account, assuming no redemptions are
effected, a group of leading global investors has committed to
participate in the transaction through a common stock private
investment in public equity (PIPE) of approximately $200 million at
$10 per share. Investors in the PIPE include Perceptive
Advisors, Redmile Group, Bain Capital Life Sciences, Invus, Avoro
Capital Advisors, Surveyor Capital (a Citadel company), Deerfield
Management Company, Wellington Management and Sphera Healthcare. In
connection with the business combination, Amicus will also invest
$50 million in cash in Caritas in exchange for additional equity in
Caritas. Together, Caritas is expected to receive proceeds of
approximately $400 million at the closing of the transactions,
assuming no redemptions are effected. Proceeds of the business
combination and the PIPE are expected to be used to advance
development of the Caritas gene therapy pipeline, discovery work,
growth across its scientific teams and to support general corporate
activities (including payment of certain transaction
expenses). A condition to closing of the business combination
transaction is that these cash proceeds are no less than $300
million in total.
The boards of directors of both Amicus and ARYA
IV have approved the proposed transaction. Completion of the
transaction, which is expected in the fourth quarter of 2021 or
early 2022, is subject to approval of ARYA IV’s shareholders,
delivery of the minimum $300 million in cash proceeds, and the
satisfaction or waiver of certain other customary closing
conditions.
AdvisorsGoldman Sachs & Co.
LLC is acting as financial and capital markets advisor to Amicus
Therapeutics. Jefferies LLC is acting as financial advisor and
private placement agent to ARYA IV. Skadden, Arps, Slate, Meagher
& Flom LLP, Wilson Sonsini Goodrich & Rosati and Troutman
Pepper Hamilton Sanders LLP are acting as legal counsel to Amicus
Therapeutics. Kirkland & Ellis LLP is acting as legal counsel
to ARYA IV.
Amicus Conference Call and
WebcastAmicus Therapeutics will host a conference call and
audio webcast today, September 29, 2021 at 8:00 a.m. ET to discuss
the transaction. Interested participants and investors may access
the conference call by dialing 877-303-5859 (U.S./Canada) or
678-224-7784 (international), conference ID: 4688658.
A live audio webcast and related presentation
materials can also be accessed via the Investors section of the
Amicus Therapeutics corporate website at ir.amicusrx.com. Web
participants are encouraged to register on the website 15 minutes
prior to the start of the call. A replay of the call will be
available for seven days beginning at 7:30 p.m. ET on September 29,
2021. Access numbers for this replay are 855-859-2056 (U.S./Canada)
and 404-537-3406 (international); conference ID: 4688658.
Caritas Deal
Roadshow WebcastA webcast of the Caritas
Therapeutics presentation materials will also be available on Deal
Roadshow:
Recorded Deal Roadshow Investor Login
Details:Wednesday, September 29, 2021 at 9:00 a.m. ETURL:
https://dealroadshow.comEntry Code: CARITAS2021Direct Link:
https://dealroadshow.com/e/CARITAS2021
A replay of the call will be available today
starting at 10:00 a.m. ET through the same Deal Roadshow link shown
above.
About Amicus Therapeutics
Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated
biotechnology company focused on discovering, developing and
delivering novel high-quality medicines for people living with rare
diseases. With extraordinary patient focus, Amicus Therapeutics is
committed to advancing and expanding a robust pipeline of
cutting-edge, first- or best-in-class medicines for rare metabolic
diseases. For more information please visit the company’s website
at www.amicusrx.com, and follow us on Twitter and LinkedIn.
About ARYA IV ARYA IV is a
blank check company newly incorporated as a Cayman Islands exempted
company for the purpose of effecting a merger, share exchange,
asset acquisition, share purchase, reorganization or similar
business combination with one or more businesses or entities. ARYA
IV is led by Chairman Joseph Edelman; Chief Executive Officer Adam
Stone; Chief Financial Officer Michael Altman; and Chief Business
Officer Konstantin Poukalov.
Participants in the
SolicitationARYA IV and its directors, executive officers,
other members of management, and employees, under SEC rules, may be
deemed to be participants in the solicitation of proxies of ARYA
IV’s shareholders in connection with the business combination.
Investors and securityholders may obtain more detailed
information regarding the names and interests in the business
combination of ARYA IV’s directors and officers in ARYA IV’s
filings with the SEC, including ARYA IV’s final prospectus which
was filed with the SEC pursuant to Rule 424(b) of the Securities
Act of 1933, as amended (the “Securities Act”) on February 19,
2021, as well as in the Registration Statement, which includes the
proxy statement of ARYA IV for the business combination.
Shareholders can obtain copies of ARYA IV’s filings with the SEC,
without charge, at the SEC’s website at www.sec.gov.
Forward Looking Statement
This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995 relating to the business combination,
development of Caritas’ product candidates, preclinical and
clinical development of our product candidates, the timing and
reporting of results from preclinical studies and clinical trials,
the prospects and timing of the potential regulatory approval of
our product candidates, commercialization plans, manufacturing
plans and financing plans. The inclusion of forward-looking
statements should not be regarded as a representation by us that
any of our plans or Caritas’ plans will be achieved. Any or all of
the forward-looking statements in this press release may turn out
to be wrong and can be affected by inaccurate assumptions we might
make or by known or unknown risks and uncertainties. For example,
with respect to statements regarding the goals, progress, timing,
and outcomes of discussions with regulatory authorities, and in
particular the potential goals, progress, timing, and results of
preclinical studies and clinical trials, and revenue goals,
including as they are impacted by COVID-19 related disruption, are
based on current information. The potential impact on operations
and/or revenue from the COVID-19 pandemic is inherently unknown and
cannot be predicted with confidence and may cause actual results
and performance to differ materially from the statements in this
release, including without limitation, because of the impact on
general political and economic conditions, including as a result of
efforts by governmental authorities to mitigate COVID-19, such as
travel bans, shelter in place orders and third-party business
closures and resource allocations, manufacturing and supply chain
disruptions and limitations on patient access to commercial or
clinical product or to treatment sites. In addition to the impact
of the COVID-19 pandemic, actual results may differ materially from
those set forth in this release due to the risks and uncertainties
inherent in our business, including, without limitation: the
potential that the transaction may not be completed in a timely
manner or at all, which may adversely affect the price of our
securities; the potential that the proposed transaction disrupts
our current plans and operations and potential difficulties in our
employee retention as a result of the transaction; the potential
that results of clinical or preclinical studies indicate that the
product candidates are unsafe or ineffective; the potential that it
may be difficult to enroll patients in clinical trials; the
potential that regulatory authorities, including the FDA, EMA, and
PMDA, may not grant or may delay approval for our product
candidates; the potential that Caritas may not be successful in
maintaining or establishing collaborations, which could adversely
affect its ability to develop products; substantial competition in
the rapidly evolving field of gene therapy, which may result in
others discovering, developing or commercializing products before
or more successfully than Caritas; the potential that regulatory
authorities approve biosimilar products with claims that compete
with any of Caritas’ product candidates; the potential that
preclinical and clinical studies could be delayed due to the
identification of serious side effects or other safety issues; the
potential that we or Caritas may not be able to manufacture or
supply sufficient clinical or commercial products; the potential
that Caritas may become involved in product liability lawsuits and
in lawsuits to protect or enforce intellectual property rights,
which could be expensive and time-consuming, and could result in
substantial liabilities and the impairment of commercialization
efforts of product candidates; and the potential that we or Caritas
will need additional funding to complete all of our respective
studies, commercialization and manufacturing. In addition, all
forward-looking statements are subject to other risks detailed in
our Annual Report on Form 10-K for the year ended December 31, 2020
and Quarterly Report 10-Q for the quarter ended June 30, 2021. You
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement, and we undertake no obligation to revise or
update this news release to reflect events or circumstances after
the date hereof.
No Offer or SolicitationThis
press release is for informational purposes only and is neither an
offer to purchase, nor a solicitation of an offer to sell,
subscribe for or buy any securities or the solicitation of any vote
in any jurisdiction pursuant to the business combination or
otherwise, nor shall there be any sale, issuance or transfer or
securities in any jurisdiction in contravention of applicable law.
No offer of securities shall be made except by means of a
prospectus meeting the requirements of the Securities Act and
otherwise in accordance with applicable law.
CONTACT:
Amicus Investors:Andrew
FaughnanExecutive Director, Investor
Relationsafaughnan@amicusrx.com(609) 662-3809
Amicus Media:Diana MooreHead of
Global Corporate Communicationsdmoore@amicusrx.com(609)
662-5079
ARYA IV:Michael AltmanChief Financial Officer
of ARYA Sciences Acquisition Corp IVArya4@perceptivelife.com
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