Workflow
Neurogene(NGNE)
icon
Search documents
Neurogene(NGNE) - 2024 Q2 - Quarterly Report
2024-08-09 20:15
UNITED STATES __________________________________________________ __________________________________________________ __________________________________________________ __________________________________ SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the tra ...
Neurogene(NGNE) - 2024 Q2 - Quarterly Results
2024-08-09 11:31
Neurogene Reports Second Quarter 2024 Financial Results and Highlights Recent Updates NGN-401 gene therapy for Rett syndrome received RMAT designation from FDA based on preliminary clinical evidence indicating the potential to address unmet medical needs NGN-401 selected for FDA START Program, also designed to accelerate development Interim NGN-401 efficacy data from Cohort 1 remains on track for 4Q:24 NEW YORK – August 9, 2024 – Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life- ...
Neurogene(NGNE) - 2024 Q1 - Quarterly Report
2024-05-10 20:14
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________ FORM 10-Q __________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ________ to ________ Commission file number: 001-36327 __________ ...
Neurogene(NGNE) - 2024 Q1 - Quarterly Results
2024-05-10 11:31
Financial Performance - Neurogene reported a net loss of $16.9 million for Q1 2024, compared to a net loss of $12.3 million for Q1 2023, reflecting an increase of 37% year-over-year[8]. - Research and Development (R&D) expenses increased to $13.5 million in Q1 2024 from $10.3 million in Q1 2023, driven by higher clinical trial costs for NGN-401[8]. - General and Administrative (G&A) expenses rose to $5.2 million in Q1 2024, up from $2.8 million in Q1 2023, primarily due to increased compensation and professional fees[8]. - Total assets decreased to $195.4 million as of March 31, 2024, from $222.6 million as of December 31, 2023[13]. - Total liabilities decreased to $24.6 million as of March 31, 2024, from $36.5 million as of December 31, 2023[13]. Cash Position - Cash, cash equivalents, and investments as of March 31, 2024, were $169.5 million, with a cash runway projected into the second half of 2026[8]. Clinical Trials and Product Development - Neurogene presented favorable safety data from the NGN-401 gene therapy trial for Rett syndrome, indicating it has been well-tolerated in all three pediatric patients[3]. - The company remains on track to provide interim efficacy data from the NGN-401 trial in Q4 2024, with additional data expected in the second half of 2025[3]. - Neurogene has received approval from the Australian Human Research Ethics Committee to conduct the NGN-401 trial in Australia, expanding the trial to a third region[3]. - The company plans to advance an additional product candidate into the clinic in 2025, utilizing transgene regulation technology[5].
Neurogene(NGNE) - 2023 Q4 - Annual Results
2024-03-18 20:10
Exhibit 99.1 Neurogene Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Updates Expanded Phase 1/2 gene therapy trial for Rett syndrome to inform future registrational study design; Company remains on track to share interim clinical data in 4Q:24 Strong financial position with runway into 2H:26 following reverse merger and private financing in December 2023 Additional Corporate Updates Fourth Quarter and Full Year 2023 Financial Results Upcoming Events NEW YORK – March 18, 2 ...
Neurogene(NGNE) - 2023 Q4 - Annual Report
2024-03-18 20:04
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K __________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36327 __________________________________ Neurogene Inc. ________________________ ...
Neurogene(NGNE) - 2023 Q3 - Quarterly Report
2023-11-14 13:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________ FORM 10-Q __________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ________ to ________ Commission file number: 001-36327 ________ ...
Neurogene(NGNE) - 2023 Q2 - Quarterly Report
2023-08-10 20:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________ FORM 10-Q __________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ________ to ________ Commission file number: 001-36327 _____________ ...
Neurogene(NGNE) - 2023 Q1 - Quarterly Report
2023-05-08 20:17
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________ FORM 10-Q __________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ________ to ________ Commission file number: 001-36327 ____________ ...
Neurogene(NGNE) - 2022 Q4 - Annual Report
2023-03-20 20:02
Financial Performance - The company incurred a net loss of $57.6 million for the year ended December 31, 2022, compared to a net loss of $60.7 million in 2021[333]. - Cash used in operating activities was $45.6 million in 2022, slightly improved from $47.6 million in 2021[330]. - The company has an accumulated deficit of $451.1 million as of December 31, 2022[330]. Expenses - Research and development expenses for the year ended December 31, 2022, were $41.1 million, an increase of 5% from $39.2 million in 2021[324]. - General and administrative expenses decreased by 17% to $18.0 million in 2022 from $21.5 million in 2021[326]. - Total operating expenses for 2022 were $59.1 million, a decrease of 3% compared to $60.7 million in 2021[322]. Restructuring and Workforce - The company announced a workforce reduction of approximately 40% as part of a strategic restructuring plan[327]. - The company expects to incur total restructuring charges of $1.8 million, with $1.4 million already incurred in 2022[328]. Cash and Investments - As of December 31, 2022, the company had cash, cash equivalents, and short-term investments totaling $96.4 million[330]. - Interest income increased significantly to $1.6 million in 2022 from $19.0 thousand in 2021 due to higher interest rates[329]. Research and Development Accounting - Research and development costs are charged to expense as incurred, including employee-related expenses, clinical trial costs, and technology licenses[345]. - No product development expenditures have been deferred to date, and costs are recorded based on the evaluation of specific tasks[346]. - Stock-based compensation is recognized over the vesting period, with all share-based payments accounted for based on grant-date fair values[347]. - The fair value of options granted is estimated using the Black-Scholes option pricing model, which involves significant estimates and judgments[348]. - There is inherent uncertainty in forecasts and projections, which could materially affect stock-based compensation expense and net loss amounts[349]. Market Risk Disclosures - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[351].