- Arcturus to receive upfront payment of $200 million and more
than $4 billion in potential development and commercial
milestones
- 40% profit sharing for COVID-19 vaccines, up to double digit
royalties for influenza, pandemic preparedness and three additional
respiratory infectious disease vaccines
- Combines Arcturus’ self-amplifying mRNA vaccine technologies
with CSL’s world-leading capabilities as a commercial scale
manufacturer and global distributor of influenza and pandemic
vaccines
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”,
Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines
company focused on the development of infectious disease vaccines
and significant opportunities within liver and respiratory rare
diseases, today announced a strategic collaboration with CSL
Seqirus, a global vaccine leader, for the research, development,
manufacture, and global commercialization of vaccines. CSL Seqirus’
vaccine portfolio includes the world’s second largest influenza
vaccine franchise. CSL Seqirus is part of CSL Limited (ASX:CSL;
USOTC:CSLLY).
Under the terms of the agreement, Arcturus will provide CSL
Seqirus with a license to their self-amplifying mRNA technology to
support the research, development, manufacture, and
commercialization of vaccines for SARS-CoV-2 (COVID-19), influenza,
pandemic preparedness, as well as three other globally prevalent
respiratory infectious diseases.
The collaboration combines CSL Seqirus’ established global
vaccine commercial and manufacturing infrastructure with Arcturus’
manufacturing expertise and innovative STARR™ self-amplifying mRNA
vaccine and LUNAR® delivery platform technologies. Arcturus will
bring its mRNA design and modification expertise, LUNAR® lipid
nanoparticle (LNP) technology and manufacturing know-how, which has
enabled the Company’s low dose, lyophilized and durable
self-amplifying mRNA vaccines against COVID-19. Previously reported
clinical results from ongoing ARCT-154 studies have demonstrated a
favorable efficacy and safety profile with sustained neutralizing
antibodies against COVID-19, including recent variants of
concern.
“We are excited to embark on this collaboration with CSL
Seqirus, a respected world leader in the development, manufacture
and commercialization of vaccines,” said Joseph Payne, President
and CEO of Arcturus Therapeutics. “We look forward to a long and
fruitful partnership as we work together to develop next generation
self-amplifying mRNA vaccines to protect against the most prevalent
infectious diseases.”
Summary of Deal Terms and Financial Considerations
Under the terms of the agreement, Arcturus will provide CSL
Seqirus with a license to its STARR™ self-amplifying mRNA
technology, LUNAR® lipid-mediated delivery, along with mRNA drug
substance and drug product manufacturing expertise. CSL Seqirus
will lead development and commercialization of vaccines under the
collaboration. The collaboration plans to advance vaccines against
SARS-CoV-2 (COVID-19), influenza, pandemic preparedness as well as
three other globally prevalent respiratory infectious diseases.
Arcturus will receive $200 million upfront and is eligible to
receive over $1.3 billion in development milestones and over $3
billion in commercial milestones. In addition, the Company is
eligible to receive a 40% net profit share for COVID-19 vaccine
products and up to double-digit royalties for vaccines against flu,
pandemic preparedness and three other respiratory pathogens.
J.P. Morgan Securities LLC acted as financial advisor to
Arcturus on the transaction.
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global, late-stage
clinical mRNA medicines and vaccines company with enabling
technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA
Technology (samRNA) and (iii) mRNA drug substance along with drug
product manufacturing expertise. Arcturus’ diverse pipeline of RNA
therapeutic and vaccine candidates includes mRNA vaccine programs
for SARS-CoV-2 (COVID-19) and Influenza, and other programs to
potentially treat ornithine transcarbamylase (OTC) deficiency, and
cystic fibrosis, along with partnered programs including glycogen
storage disease type III, and hepatitis B virus. Arcturus’
versatile RNA therapeutics platforms can be applied toward multiple
types of nucleic acid medicines including messenger RNA, small
interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and
gene editing therapeutics. Arcturus’ technologies are covered by
its extensive patent portfolio (patents and patent applications
issued in the U.S., Europe, Japan, China and other countries). For
more information, visit www.ArcturusRx.com. In addition, please
connect with us on Twitter and LinkedIn.
About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a leading global biotechnology
company with a dynamic portfolio of lifesaving medicines, including
those that treat haemophilia and immune deficiencies, vaccines to
prevent influenza, and therapies in iron deficiency, dialysis and
nephrology. Since our start in 1916, we have been driven by our
promise to save lives using the latest technologies. Today, CSL –
including our three businesses, CSL Behring, CSL Seqirus and CSL
Vifor – provides lifesaving products to patients in more than 100
countries and employs 30,000 people. Our unique combination of
commercial strength, R&D focus and operational excellence
enables us to identify, develop and deliver innovations so our
patients can live life to the fullest. For inspiring stories about
the promise of biotechnology, visit CSLBehring.com/Vita and follow
us on Twitter.com/CSL. For more information about CSL, visit
www.CSL.com.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the
largest influenza vaccine providers in the world, CSL Seqirus is a
major contributor to the prevention of influenza globally and a
transcontinental partner in pandemic preparedness. With
state-of-the-art production facilities in the U.S., the U.K. and
Australia, and leading R&D capabilities, CSL Seqirus utilizes
egg, cell and adjuvant technologies to offer a broad portfolio of
differentiated influenza vaccines in more than 20 countries around
the world. For more information about CSL Seqirus, visit
www.seqirus.com.
Forward Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. Any statements, other than statements of historical
fact included in this press release, are forward-looking
statements, including those regarding strategy, the expectations
for beginning the collaboration with CSL Seqirus, including
receiving clearance under the Hart-Scott-Rodino Antitrust
Improvements Act and satisfying other closing conditions, or the
likelihood of success of the collaboration with CSL Seqirus or any
collaborations, the likelihood of success of the Company’s efforts
to design and develop a vaccine against COVID, influenza or any
other infectious disease, the strength or potential of the
Company’s platform, the future activities under and effectiveness
of the collaboration, and the impact of general business and
economic conditions. Arcturus may not actually achieve the plans,
carry out the intentions or meet the expectations or projections
disclosed in any forward-looking statements such as the foregoing
and you should not place undue reliance on such forward-looking
statements. These statements are only current predictions or
expectations, and are subject to known and unknown risks,
uncertainties, and other factors that may cause our or our
industry’s actual results, levels of activity, performance or
achievements to be materially different from those anticipated by
the forward-looking statements, including those discussed under the
heading "Risk Factors" in Arcturus’ most recent Annual Report on
Form 10-K, and in subsequent filings with, or submissions to, the
SEC, which are available on the SEC’s website at www.sec.gov.
Except as otherwise required by law, Arcturus disclaims any
intention or obligation to update or revise any forward-looking
statements, which speak only as of the date they were made, whether
as a result of new information, future events or circumstances or
otherwise.
Trademark Acknowledgements
The Arcturus logo and other trademarks of Arcturus appearing in
this announcement, including LUNAR® and STARR™, are the property of
Arcturus. All other trademarks, services marks, and trade names in
this announcement are the property of their respective owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20221101006199/en/
IR and Media Contacts Arcturus Therapeutics
IR@ArcturusRx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008
ctanzi@kendallir.com
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