STOK — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-03

• In March 2026, we filed an automatic universal Shelf Registration Statement on Form S-3 (the “2026 Registration Statement”) with the SEC. The 2026 Registration Statement contains two prospectuses: a base prospectus, which covers the offering, issuance and sale

• Presentations of new clinical data for zorevunersen at medical congresses have contributed to greater understanding of its disease-modifying potential that is highly differentiated from any currently available treatments. The Company will continue its educational efforts at major neurology and epile…

• EMPEROR is a global, pivotal Phase 3 study. In June 2026, we announced completion of enrollment of 162 patients in the U.S., UK, and Japan, where patients are randomized to treatment with zorevunersen or a sham control administered via lumbar puncture (LP). A Phase 3 data readout is anticipated in t…

• An additional cohort of approximately 30 patients is currently being enrolled in Europe, where the sham control is administered via a needle prick (NP).  Screening for this cohort has now closed, and enrollment is expected to be completed in August 2026.

• Site activation and screening are also underway in China, where zorevunersen has been granted Breakthrough Therapy Status. Enrollment is anticipated to complete in the second half of 2026.

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

• In March 2026, we filed an automatic universal Shelf Registration Statement on Form S-3 (the “2026 Registration Statement”) with the SEC. The 2026 Registration Statement contains two prospectuses: a base prospectus, which covers the offering, issuance and sale by us of our common stock, preferred st…

• Presentations of new clinical data for zorevunersen at medical congresses have contributed to greater understanding of its disease-modifying potential that is highly differentiated from any currently available treatments. In May 2026, we announced new findings from four-year longitudinal data from t…

• As shown in Exhibit 1, durable reductions in major motor seizure frequency on top of standard-of-care anti-seizure medicines were observed at year four of zorevunersen treatment. The data also demonstrate continuing improvements in cognition and behavior over the treatment period, as shown in Exhibi…

• EMPEROR is a global, pivotal Phase 3 study. New patient entry into screening for the U.S., UK, and Japan cohort is closed and patients currently in screening are progressing through the 8-week screening period. Following successful completion of screening, these patients will be randomized to treatm…

• In Europe, sites are active and patient screening is underway for an additional cohort of at least 20 patients. Enrollment in this cohort is expected to be completed in the third quarter of 2026. Data from the European cohort are not planned for inclusion in the U.S. NDA submission.

Text added vs the prior filing · source: 10-Q · 2026-08-03

• conducive general economic, industry and market conditions, including interest rates, inflation, market volatility and tariffs;

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

• the direct and indirect impact of general economic, industry and market conditions, including fluctuating interest rates, inflation, market volatility, tariffs, potential recessions, a potential federal government shutdown, and any health pandemic on our business and operations, third party vendors,…

Text added vs the prior filing · source: 10-Q · 2026-08-03

• *Intended to satisfy the affirmative defense of Rule 10b5-1(c) of the Act.

• **Not intended to satisfy the affirmative defense of Rule 10b5-1(c) of the Act.

• (1) Except as indicated by footnote, each trading arrangement permitted or permits transactions through and including the earlier of (a) the completion of all purchases or sales or (b) the date listed in the table.

• Each new Rule 10b5-1 Plan that was adopted in the above table includes a representation from the director or officer, respectively, to the broker administering the plan that such director or officer was not in possession of any material nonpublic information regarding the Company or the securities s…

• Once executed, transactions under a Rule 10b5-1 Plan adopted during the period described above will be disclosed publicly through Form 4 and/or Form 144 filings with the SEC in accordance with applicable securities laws, rules, and regulations. Except as may be required by law, we do not undertake a…