Skip to main content

Autolus Therapeutics plc

For the period ended Jun 30, 2025. Filed Aug 12, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2025 · Filed Aug 12, 2025

AUTL$1.32+3.1%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits

Item 5. Other Information

Insider Trading Arrangements

During the three months ended June 30, 2025, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act)adopted orterminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

Voluntary Withdrawal of Orphan Drug Designation for obe-cel in the European Union

As previously reported, in March 2022, our product obe-cel received European Commission orphan drug designation. In June 2025, we met with the European Medicines Agency's Committee for Orphan Medicinal Products, which is responsible for assessing continued eligibility for EU orphan drug designation. Following such meeting, in June 2025, we voluntarily withdrew obe-cel from the EU register of orphan medicinal products. In July 2025, following a thorough evaluation of the commercial viability of marketing obe-cel in the European Union without an orphan designation, as well as the challenges associated with the framework of pricing policies for advanced cell therapies within the European Union and the potential impact of proposed most favored nations pricing policies in the United States, we put the launch of obe-cel in Germany on hold. Evaluation of potential pricing and feasibility of market entry opportunities is ongoing.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.