Neurogene SEC Filings

Neurogene Inc. (NGNE) filed its Q3 2025 10‑Q, reporting a net loss of $20.953 million as operating expenses rose with advancing gene therapy programs. Revenue was none. Research and development expense was $17.241 million and general and administrative expense was $6.557 million; other income contributed $2.845 million. Net loss per share was $0.99.

Liquidity remains strong with cash, cash equivalents and short‑term investments totaling $265.4 million as of September 30, 2025. Year‑to‑date operating cash use was $59.7 million. The company sold 500,000 shares via its at‑the‑market program for $9.8 million net in September, and subsequently raised $20.6 million net from 700,000 shares in October.

Program updates: the registrational Embolden trial of NGN‑401 for Rett syndrome began dosing its first participant in Q4 2025 after FDA alignment on key design elements; NGN‑401 holds RMAT designation and is in FDA’s START pilot. Interim Phase 1/2 data (pediatric cohort at the 1E15 vg dose) showed multidomain developmental gains and a tolerability profile with only Grade 1–2 treatment‑related AEs. Shares outstanding were 14,775,285 as of September 30, 2025; 15,489,800 as of November 11, 2025.

Neurogene Inc. (NGNE) furnished an Item 7.01 update announcing positive, updated interim clinical data from the pediatric (ages 4–10) cohort of its ongoing Phase 1/2 trial of NGN-401 gene therapy for females with Rett syndrome. The company also posted a related corporate presentation. A press release (Exhibit 99.1) and the presentation (Exhibit 99.2) were furnished, not filed, on November 12, 2025.

Neurogene Inc. (NGNE) reported a clinical milestone: the first patient has been dosed in the Embolden registrational trial of NGN-401 for Rett syndrome. The company furnished a press release and an updated corporate presentation highlighting ongoing enrollment and dosing activity.

The materials were provided as Exhibit 99.1 (press release) and Exhibit 99.2 (corporate presentation). The information was furnished under Item 7.01 and is not deemed “filed” for purposes of Section 18 of the Exchange Act or incorporated by reference, except as specifically referenced.

Commodore Capital LP and Commodore Capital Master LP report beneficial ownership of 427,866 shares of Neurogene Inc. common stock, representing 3.0% of the 14,269,264 shares disclosed as outstanding. The filing states the Firm acts as investment manager to Commodore Capital Master LP and that two managing partners, Michael Kramarz and Robert Egen Atkinson, exercise investment discretion over these shares. All voting and dispositive powers are reported as shared for the 427,866 shares; no sole voting or dispositive power is claimed. The filing includes a certification that the shares were not acquired to influence control of the issuer.

Neurogene Inc. (NGNE) filed a prospectus supplement to sell up to $150,000,000 of common stock through an "at the market" sales agreement with Leerink Partners dated August 11, 2025. Leerink may sell shares from time to time as sales agent for up to 3.0% commission. The prospectus uses the last reported Nasdaq sale price of $21.29 per share on August 6, 2025 as an illustrative price and estimates up to 21,314,825 shares outstanding after an assumed sale of 7,045,561 shares at that price. Net tangible book value was $273.3 million or $19.15 per share as of June 30, 2025; after the assumed sale this would be $418.5 million or $19.63 per share, implying immediate dilution of $1.66 per share to new investors. Proceeds are intended for working capital and advancing preclinical and clinical programs. The filing reiterates clinical program status: Phase 1/2 dosing for NGN-401 is complete and registrational trial activities (Embolden TM) have begun; the NGN-101 CLN5 program is not expected to move forward after an RMAT denial. The company states it is a "smaller reporting company" and highlights standard risk factors, including substantial future capital needs and volatility of its stock.

On August 11, 2025, Neurogene Inc. reported that it issued a press release announcing financial results for the quarter ended June 30, 2025 and posted an updated corporate presentation on its website. The Form 8-K attaches Exhibit 99.1 (press release) and Exhibit 99.2 (corporate presentation) and states these exhibits are being furnished, not filed, so they are not subject to Section 18 liabilities or deemed incorporated by reference. The filing text does not include the actual earnings figures; the report is signed by Christine Mikail, President and Chief Financial Officer.