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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
Financial Performance - Total operating loss for 2021 was $60.7 million, up 80% from a loss of $33.7 million in 2020[315] - Net cash used in operating activities was $47.6 million in 2021, compared to $24.6 million in 2020, reflecting increased operating expenses[325] - The company reported a total other income of $6,000 in 2021, a 99% decrease from $451,000 in 2020[321] - The company incurred net cash used in investing activities of $3.3 million in 2021, primarily for laboratory equipment and office furnishings[326] - As of December 31, 2021, the company had an accumulated deficit of $393.5 million and cash and cash equivalents of $142.5 million[322] Expenses - Research and development expenses increased to $39.2 million in 2021 from $24.3 million in 2020, representing a 61% increase[315] - General and administrative expenses rose to $21.5 million in 2021 from $17.2 million in 2020, a 25% increase[319] Capital Resources - The company expects existing capital resources to fund operations into the second half of 2023[328] - The company entered into an ATM Equity Offering Sales Agreement with BofA for an aggregate offering price of up to $40 million, with no sales made to date[323] Stock-Based Compensation - The company measures the cost of stock-based compensation based on the grant-date fair value of the award, recognized over the vesting period[339] - The fair value of options granted is estimated using the Black-Scholes option pricing model, which involves significant estimates regarding expected term, stock price volatility, and risk-free interest rate[340] - There is inherent uncertainty in the company's forecasts and projections, which could materially affect stock-based compensation expense, net loss, and net loss per common stock amounts[341] Licensing and Agreements - The company has an exclusive license agreement with UW, which includes potential milestone payments of up to $10 million based on cumulative net sales of licensed products[334] Market Risk - As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk[343]
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 ________ ...
Neurogene(NGNE) - 2021 Q2 - Quarterly Report
2021-08-05 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________ For the transition period from ________ to ________ Commission file number: 001-36327 __________________________________________________ Neoleukin Therapeutics, Inc. (Exact name of registrant as specified in its charter) __________________________________________________ Delaware 98-0542593 (State or other jurisdiction of incorporation or organization) FORM 10-Q __________________________ ...
Neoleukin Therapeutics (NLTX) Investor Presentation - Slideshow
2021-05-14 19:42
neoleukin" THERAPEUTICS May 12, 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 clinical tr ...
Neurogene(NGNE) - 2021 Q1 - Quarterly Report
2021-05-12 12:07
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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ________ to ________ (I.R.S. Employer Identification No.) 188 East ...
Neurogene(NGNE) - 2020 Q4 - Earnings Call Transcript
2021-03-25 23:22
Neoleukin Therapeutics, Inc. (NLTX) Q4 2020 Earnings Conference Call March 25, 2021 4:30 PM ET Company Participants Julie Rathbun - Communications Jonathan Drachman - Chief Executive Officer Robert Ho - Chief Financial Officer Daniel-Adriano Silva - Head of Research Carl Walkey - Senior Vice President of Corporate Development Umut Ulge - Vice President of Clinical Development Conference Call Participants Tyler Van Buren - Piper Sandler Arlinda Lee - Canaccord Genuity Operator Good morning and thank you for ...