Presentation will take place at the 2019 Annual Meeting of TIDES: Oligonucleotide and Peptide Therapeutics
San Diego CA— Arcturus Therapeutics Ltd. (NASDAQ: ARCT) (the “Company”), a leading messenger RNA medicines company focused on the discovery, development and commercialization of therapeutics for rare diseases, today announced that Pad Chivukula, Ph.D., Chief Scientific and Chief Operating Officer of Arcturus, will present data for ARCT-810 along with data for the Company’s mRNA + LUNAR® platform in a presentation titled “LUNAR®: Enabling Delivery of mRNA Therapeutics and Vaccines” at the2019 Annual Meeting of TIDES: Oligonucleotide and Peptide Therapeutics, being held May 20-23, 2019 in San Diego, California.
“Arcturus is fortunate to have a team of talented scientists that continue to generate quality data through rigorous science and innovation,” said Dr. Chivukula. “I look forward to sharing the progress we have made on ARCT-810 and additional data for the growing Arcturus mRNA therapeutics platform enabled by LUNAR.”
- Arcturus is presenting the following OTC program-related data at the 2019 Annual Meeting of TIDES:
— Reduction of biomarkers, urinary orotate and plasma ammonia, in mice
— Human OTC protein expression quantified in periportal hepatocytes in mice
— Human OTC protein expression quantified in primate livers - Regarding the Arcturus mRNA + LUNAR® Platform, the following data are also being presented:
— Uniform distribution of protein expression in non-human primate (NHP) livers
— Protein accumulation in mouse liver following repeated intravenous dosing of mRNA + LUNAR®
— Protein expression in bronchial epithelial cells following inhaled dosing of mRNA + LUNAR®
— mRNA structure design and optimization - Arcturus remains on track to file an Investigational New Drug (IND) application for ARCT-810, a messenger RNA (mRNA) medicine to potentially treat ornithine transcarbamylase (OTC) deficiency, with the U.S. Food and Drug Administration (FDA) in 4Q 2019.
- Completed manufacture of Drug Substance and Drug Product using Arcturus proprietary processes:
— GMP-grade OTC mRNA Drug Substance (> 10 grams)
— Multiple batches of LUNAR®-formulated OTC mRNA Drug Product (10 grams each)
— Current inventory is sufficient to support IND-enabling studies and early clinical development
About TIDES: Oligonucleotide and Peptide Therapeutics
TIDES is the world’s largest meeting to accelerate oligonucleotide and peptide products from early discovery to late-stage development and commercialization. The conference is attended by more than 1,200 global oligonucleotide and peptide professionals. For more information, visit https://lifesciences.knect365.com/tides/.
About Arcturus Therapeutics Ltd
Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Ltd. (NASDAQ: ARCT) is an RNA medicines company with enabling technologies – UNA Oligomer chemistry and LUNAR® lipid-mediated delivery. Arcturus’ diverse pipeline of RNA therapeutics includes programs pursuing rare diseases, Hepatitis B, non-alcoholic steatohepatitis (NASH), cystic fibrosis, and vaccines. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of RNA medicines including small interfering RNA, messenger RNA, replicon RNA, antisense RNA, microRNA and gene editing therapeutics. Arcturus owns LUNAR lipid-mediated delivery and Unlocked Nucleomonomer Agent (UNA) technology including UNA Oligomers, which are covered by its extensive patent portfolio (152 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ proprietary UNA technology can be used to target individual genes in the human genome, as well as viral genes, and other species for therapeutic purposes. Arcturus’ commitment to the development of novel RNA therapeutics has led to partnerships with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, Synthetic Genomics Inc. and the Cystic Fibrosis Foundation. For more information, visit www.Arcturusrx.com, the content of which is not incorporated herein by reference.
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 regarding strategy, future operations, collaborations, future financial position, prospects, plans and objectives of management, the likelihood of success of the Company’s technology or potential development of any products, including statements relating to the completion and timing of the Redomiciliation from Israel to Delaware, the status of the preclinical development program for any of the clinical development programs of Arcturus, the status of IND-enabling studies and early clinical development related to any of the clinical development programs of Arcturus, the sufficiency of any drug substances or drug products of the Company to meet the Company’s current clinical goals or expectations, the date that an IND may be filed with the FDA, the potential market or success for the clinical development programs of Arcturus, current standards of care, and the Company’s future cash and financial position are forward-looking statements. 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. Actual results and performance could differ materially from those projected in any forward-looking statements as a result of many factors, including without limitation, an inability to develop and market product candidates, inability to generate positive verifiable data, unexpected clinical results, unforeseen expenses and general market conditions that may prevent such achievement or performance. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading “Risk Factors” in Arcturus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2018, filed with the SEC on March 18, 2019 and in subsequent filings with, or submissions to, the SEC. 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.