ARCT — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Our internal pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), both rare diseases. In our vaccine program, following termination of the CSL Collaboration Agreement, we regained strategic control of KOSTAIVE® and ou…

• We have completed enrollment in the open-label multiple ascending dose Phase 2 study of ARCT-810 and all enrolled subjects have completed study drug dosing. The study evaluates safety and pharmacodynamics in adult and adolescent patients requiring clinical management for OTC deficiency. We continue …

• On June 26, 2026, we entered into a series of agreements with Thermo Fisher Scientific Inc. (“Thermo Fisher”) and certain of Thermo Fisher’s affiliates to establish a strategic collaboration for the provision of contract development and manufacturing organization (“CDMO”) and contract research organ…

• The Thermo Fisher MSA establishes the framework under which Thermo Fisher and its affiliates will provide CRO and CDMO services to Arcturus from time to time pursuant to the Project Agreement and any additional individual project addendums. CRO services will be provided through PPD, Inc., Thermo Fis…

• Under the Project Agreement, the services to be provided include technical transfer, engineering batches, manufacture of clinical trial materials, manufacture of process performance qualification batches, open-label extension batches, drug product fill and finish, product release, and stability stud…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• Our internal pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), both rare diseases. In our vaccine program, we have partnered with CSL Seqirus, one of the world’s leading influenza vaccine providers, on the developm…

• We continue to enroll participants in the open-label multiple ascending dose Phase 2 study of ARCT-810. The study evaluates safety and pharmacodynamics in adult and adolescent patients requiring clinical management for OTC-deficiency.

• In March 2026, we held a type C meeting with the FDA to discuss our plans for a proposed future pediatric study. The FDA provided a path forward toward a pivotal pediatric study that would require us to collect additional exploratory data to establish the optimal dose and therapeutic effect. The FDA…

• In November 2022, we entered into a Collaboration and License Agreement (as amended, the “CSL Collaboration Agreement”) with Seqirus, Inc. (“CSL Seqirus”), a part of CSL Limited, and one of the world’s leading influenza vaccine providers, for global exclusive rights to research, develop, manufacture…

• Meiji has launched in Japan the two-dose vial of KOSTAIVE updated for the JN.1 variant XEC in August 2025, following approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Text added vs the prior filing · source: 10-Q · 2026-08-06

• On August 3, 2026, we entered into a Termination and Settlement Agreement with CSL Seqirus, pursuant to which the parties agreed to dismiss the arbitration with CSL Seqirus that was before the International Chamber of Commerce, seeking payment of a milestone under the CSL Collaboration Agreement bas…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• On May 30, 2025, we initiated an arbitration against CSL Seqirus before the International Chamber of Commerce, seeking payment of a milestone under the CSL Collaboration Agreement based on the European Commission’s grant of marketing authorization for a presentation of KOSTAIVE® in the European Unio…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Lance Kurata, our Chief Legal Officer, adopted a Rule 10b5-1 trading arrangement as of May 15, 2026. Mr. Kurata's trading arrangement provides for the exercise of options to purchase up to 30,000 shares of common stock and the subsequent sale of up to an aggregate of 30,000 shares of common stock, b…

• Dr. Padmanabh Chivukula, Chief Scientific Officer and Chief Operating Officer, adopted a Rule 10b5-1 trading arrangement on May 14, 2026. Dr. Chivukula’s trading arrangement provides for the sale of up to an aggregate of 60,000 shares of common stock, beginning on August 14, 2026 and ending on Decem…

• On August 3, 2026, we entered into the Termination Agreement with CSL Seqirus pursuant to which we mutually terminated the CSL Collaboration Agreement, effective as of such date. Under the Termination Agreement, we received a one-time cash payment of $12.0 million from CSL Seqirus. In addition, we w…

• As a result of the termination, we regained strategic control of our vaccine portfolio, including KOSTAIVE® and our vaccine programs for seasonal influenza, pandemic influenza, RSV and EBV, subject to ongoing arrangements with Meiji Seika Pharma (“Meiji”) for the Northern Hemisphere 2026-2027 season…

• We are obligated to pay CSL Seqirus single-digit royalties and revenue-sharing payments on our future commercialization of vaccine products formerly licensed under the CSL Collaboration Agreement and successor products, where certain CSL Seqirus intellectual property is incorporated into such produc…