Arcturus Therapeutics Partners with Ultragenyx for Cystic Fibrosis Drug

TL;DR

Arcturus inks deal with Ultragenyx for cystic fibrosis RNA drug ARCT-032.

AI Summary

Arcturus Therapeutics Holdings Inc. announced on March 19, 2024, that it has entered into a clinical supply agreement with Ultragenyx Pharmaceutical Inc. for its investigational RNA therapeutic, ARCT-032. This agreement allows Ultragenyx to use ARCT-032 in its upcoming Phase 2 study for cystic fibrosis, with Arcturus receiving milestone payments and royalties.

Why It Matters

This collaboration could accelerate the development of a new treatment for cystic fibrosis and validates Arcturus's RNA therapeutic platform.

Risk Assessment

Risk Level: medium — The success of ARCT-032 is still subject to clinical trial results and regulatory approval, and the partnership's financial terms are not fully disclosed.

Key Players & Entities

• Arcturus Therapeutics Holdings Inc. (company) — Registrant
• Ultragenyx Pharmaceutical Inc. (company) — Partner company
• ARCT-032 (drug) — Investigational RNA therapeutic
• March 19, 2024 (date) — Date of report
• cystic fibrosis (disease) — Indication for ARCT-032

FAQ

Key Financial Figures

• $0.001 — ch registered Common stock, par value $0.001 per share ARCT The NASDAQ Stock Mar

Filing Documents

• e619378_8k-arct.htm (8-K) — 27KB
• e619378_ex99-1.htm (EX-99.1) — 6KB
• image_001.jpg (GRAPHIC) — 21KB
• 0001193805-24-000392.txt ( ) — 235KB
• arct-20240319.xsd (EX-101.SCH) — 3KB
• arct-20240319_lab.xml (EX-101.LAB) — 33KB
• arct-20240319_pre.xml (EX-101.PRE) — 22KB
• e619378_8k-arct_htm.xml (XML) — 4KB

01

Item 7.01 Regulation FD Disclosure. On March 19, 2024, Meiji Holdings Co., Ltd. announced that its subsidiary, Meiji Seika Pharma Co., Ltd. ( " Meiji "), announced today that a bivalent version of Kostaive (ARCT-2301), Arcturus Therapeutics Holdings Inc.'s (the " Company " or " Arcturus ") self-amplifying mRNA vaccine against COVID-19, met the primary endpoint in a Phase III clinical study for booster vaccination conducted in Japan. As previously announced on April 11, 2023, Meiji entered into a distribution agreement with Seqirus, Inc. (" CSL Seqirus "), a part of CSL Limited, and one of the world's leading influenza vaccine providers, for the distribution and sales of the Company's self-amplifying mRNA vaccine candidate against COVID-19 in Japan. A copy of Meiji's press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference. The information set forth in this Item 7.01, including Exhibit 99.1, is furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the " Exchan g e Act "), or otherwise subject to the liabilities of that Section. The information in this Item 7.01 shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in such a filing. Cautionary Note Regarding Forward-Looking Statements This Current Report on Form 8-K 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 Current Report on Form 8-K, are forward-looking the likelihood that preclinica

Financial Statements and Exhibits

Financial Statements and Exhibits . (d) Exhibits Exhibit No. Description 99.1 Press Release dated March 19, 2024

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Arcturus Therapeutics Holdings Inc. Date: March 19, 2024 By: /s/ Joseph E. Payne Name: Joseph E. Payne Title: Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR