Neurogene(NGNE)

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Neurogene(NGNE) - 2022 Q3 - Quarterly Report
2022-11-14 21:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q __________________________________________________ (Mark One) Washington, DC 20549 __________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 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 Q2 - Earnings Call Presentation
2022-08-10 04:58
Corporate Presentation August 2022 © Neoleukin Therapeutics. All Rights Reserved. Forward Looking Statements Certain of the statements made in these slides and the accompanying oral presentation are forward looking, including those relating to Neoleukin's business, strategy, future operations, advancement of its product candidates and product pipeline, clinical development of its product candidates, including expectations regarding timing of regulatory submissions and initiation of clinical trials, regulato ...
Neurogene(NGNE) - 2022 Q2 - Earnings Call Transcript
2022-08-10 04:55
Neoleukin Therapeutics, Inc. (NLTX) Q2 2022 Earnings Conference Call August 9, 2022 4:30 PM ET Company Participants Julie Rathbun - Investor Relations Jonathan Drachman - Chief Executive Officer Priti Patel - Chief Medical Officer Sean Smith - Vice President, Finance Conference Call Participants Mary Kate - Bank of America Charles Zhu - Guggenheim Securities Ben Burnett - Stifel Mara Goldstein - Mizuho Securities Operator Good afternoon and thank you for joining us today for the Neoleukin Therapeutics Confe ...
Neurogene(NGNE) - 2022 Q2 - Quarterly Report
2022-08-09 20:07
Financial Performance - The company reported a net loss of $31.0 million for the six months ended June 30, 2022, compared to a net loss of $30.1 million for the same period in 2021[88]. - Cash used in operating activities was $25.4 million for the six months ended June 30, 2022, a slight decrease from $26.6 million in the same period in 2021[85]. - As of June 30, 2022, the company had an accumulated deficit of $424.5 million and working capital of $109.2 million[85]. - The net change in cash, cash equivalents, and restricted cash was a decrease of $64.9 million for the six months ended June 30, 2022, compared to a decrease of $28.3 million in the same period in 2021[87]. - The company has not generated product revenue or achieved profitability since inception and anticipates continued net losses[92]. Research and Development - Research and development expenses for Q2 2022 were $11.0 million, an increase of 12% from $9.8 million in Q2 2021[81]. - The company reported a 12% increase in research and development expenses for the first half of 2022, primarily due to increased clinical trial expenses for NL-201[81]. - The Phase 1 clinical trial of NL-201 is planned to enroll up to 252 patients, with approximately 120 patients receiving NL-201 as monotherapy[67]. - The trial is evaluating doses escalating from 0.1 μg/kg to 24 μg/kg, with interim data expected to be disclosed in 2023[68]. - The company plans to initiate a Phase 1 clinical trial in hematological malignancies, dependent on data from the ongoing solid tumor trial[69]. - The company has incorporated machine learning into its de novo protein design methods to accelerate the development of potential therapeutics[71]. Capital and Financing - The company needs to raise substantial additional capital to support operations and growth strategy, with no assurances of obtaining adequate financing[74]. - Cash, cash equivalents, and short-term investments totaled $116.5 million as of June 30, 2022, which is expected to fund operations through 2023[92]. - The company incurred $39.8 million in cash used for investing activities during the six months ended June 30, 2022, compared to $2.3 million in the same period in 2021[87]. - The company entered into an ATM Equity Offering Sales Agreement with BofA for an aggregate offering price of up to $40.0 million, but no sales have been made to date[86]. - The company expects future capital requirements to vary significantly and may need to seek additional funds sooner than planned[92]. Operating Expenses - Total operating expenses for the first half of 2022 were $31.2 million, a 4% increase from $30.1 million in the same period of 2021[79]. - General and administrative expenses for Q2 2022 were $4.9 million, a decrease of 7% from $5.3 million in Q2 2021[83]. - Interest income increased significantly to $194,000 for the three months ended June 30, 2022, compared to $5,000 in the same period in 2021, reflecting a 3780% increase[84].
Neoleukin Therapeutics (NLTX) Investor Presentation - Slideshow
2022-05-13 18:42
Corporate Presentation May 2022 @Neoleukin Therapeutics. All Rights Reserved. Forward Looking Statements Certain of the statements made in these slides and the accompanying oral presentation are forward looking, including those relating to Neoleukin's business, strategy, future operations, advancement of its product candidates and product pipeline, clinical development of its product candidates, including expectations regarding timing of regulatory submissions and initiation of clinical trials, regulatory r ...
Neurogene(NGNE) - 2022 Q1 - Quarterly Report
2022-05-09 20:10
(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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________ FORM 10-Q __________________________________________________ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Se ...
Neurogene(NGNE) - 2021 Q4 - Earnings Call Transcript
2022-03-02 01:56
Financial Data and Key Metrics Changes - The company ended 2021 with cash and cash equivalents of $142.5 million, down from $192.6 million at the end of 2020 [28] - Research and development expenses for the year were $39.2 million, compared to $24.3 million in 2020, primarily due to increased clinical trial activities related to NL-201 and personnel-related costs [28] - General and administrative expenses increased to $21.5 million from $17.2 million in 2020, mainly due to personnel-related costs [29] - The net loss for 2021 was $60.7 million, up from $33.3 million in 2020, driven by increased clinical trial expenses and costs related to the new headquarters [30] - Operating cash burn for the year was approximately $50 million, and the company believes its cash on hand will be sufficient to fund operations into the second half of 2023 [30] Business Line Data and Key Metrics Changes - The company has transitioned to a clinical stage company with the first patient treated in a Phase 1 clinical trial for NL-201 in May 2021 [12] - The Phase 1 trial of NL-201 is currently active at 8 sites across the U.S., Australia, and Canada, with good investigator engagement and rapid patient enrollment [17] Market Data and Key Metrics Changes - The company presented preclinical data at multiple scientific conferences in 2021, focusing on NL-201's effects on the tumor microenvironment and a novel IL-2 and IL-15 inhibitor molecule [13] Company Strategy and Development Direction - The company aims to report interim Phase 1 dose escalation data on NL-201 in the second half of 2022, which will be the first data of a fully de novo protein in patients [14] - Plans include initiating a combination of NL-201 and pembrolizumab in patients with advanced solid tumors and evaluating NL-201 in hematologic malignancies [14][20] - The company is focused on advancing its de novo protein technology platform to benefit patients with serious diseases, including cancer, inflammation, and autoimmune diseases [33] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that while the rate of growth slowed in 2021, the company is well-positioned with a strong team and expanded facilities to make rapid progress [12] - The management expressed optimism about the upcoming milestones in 2022 and the potential of NL-201 to perform well in patients [32] Other Important Information - The company has made key leadership transitions, including the appointment of a new CMO and VP of Research, which are expected to significantly impact clinical and research efforts [10][11] - A clinical trial collaboration with Merck was announced to evaluate the safety and efficacy of NL-201 in combination with pembrolizumab [18] Q&A Session Summary Question: What level of monotherapy activity for NL-201 in solid tumors would be clinically meaningful? - Management indicated that the initial data will focus on safety and tolerability, with preliminary efficacy data expected by the end of 2022 [39][40] Question: Are there specific PD markers that may predict clinical activity? - Management noted that while biomarkers are challenging to correlate with clinical outcomes, NL-201's immune activation at low doses may provide a favorable immune activation versus immunosuppressive ratio [43][44] Question: What are the plans for exploring intratumoral delivery? - Management expressed interest in intratumoral dosing and is exploring opportunities for this method of delivery [47] Question: How should the company be viewed in terms of dose escalation and patient follow-up? - Management stated that dose escalation is proceeding as expected, and the data presented this year will be preliminary, requiring long-term follow-up for a complete understanding of NL-201's potential [55] Question: What are the enrollment dynamics for the combination trial with pembrolizumab? - Management indicated that the combination trial will utilize existing sites and investigators, with enrollment expected to start soon [63] Question: Will NL-201 be developed as a monotherapy in hematologic malignancies? - Management sees potential for NL-201 as a monotherapy in both solid tumors and hematologic malignancies, with plans to explore various combinations [71]
Neurogene(NGNE) - 2021 Q4 - Annual Report
2022-03-01 21:08
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ FORM 10-K _________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ 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 _________________________ Neoleukin Therapeutics, Inc. ( ...
Neoleukin Therapeutics (NLTX) Investor Presentation - Slideshow
2021-11-23 13:22
neoleukin" Corporate Presentation November 2021 Forward Looking Statements Certain of the statements made in these slides and the accompanying oral presentation are forward looking, including those relating to Neoleukin's business, strategy, future operations, advancement of its product candidates and product pipeline, clinical development of its product candidates, including expectations regarding timing of regulatory submissions and initiation of clinical trials, regulatory requirements for initiation of ...
Neurogene(NGNE) - 2021 Q3 - Quarterly Report
2021-11-04 20:12
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, 2021 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 ________ ...