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 _____________ ...

Financial Performance - For the three months ended March 31, 2023, research and development expenses were $7.7 million, a decrease of 28% from $10.7 million in the same period of 2022[84]. - General and administrative expenses for the same period were $4.0 million, down 14% from $4.7 million in the prior year[86]. - Total operating expenses for the three months ended March 31, 2023, were $15.1 million, a slight decrease of 1% from $15.4 million in the same period of 2022[82]. - The net loss for the three months ended March 31, 2023, was $14.2 million, adjusted for non-cash items including impairment of $3.4 million and stock-based compensation of $1.2 million[96]. - For the three months ended March 31, 2023, the net cash used in operating activities was $(13,033) thousand, compared to $(14,091) thousand for the same period in 2022, indicating a 7.5% improvement[95]. Restructuring and Workforce Changes - The company reduced its workforce by approximately 40% in November 2022 and by an additional 70% in March 2023 as part of its restructuring plans[72][89]. - The restructuring plans are expected to incur aggregate charges of $1.7 million and $1.8 million for the November 2022 and March 2023 reductions, respectively[88][90]. - The company has suspended its research and development activities following the decision to discontinue the development of NL-201[78]. Cash and Financing - The company had an accumulated deficit of $465.3 million and cash, cash equivalents, and short-term investments of $83.4 million as of March 31, 2023[93]. - As of March 31, 2023, the company had approximately $83.4 million in cash, cash equivalents, and short-term investments, expected to fund operations for at least the next 12 months[99]. - The company plans to finance operations through equity sales, debt financing, or strategic transactions, with no assurance of success in obtaining adequate financing[79]. - Future capital requirements may vary significantly, and the company may need to seek additional funding sooner than planned[99]. - The company may face challenges in obtaining additional equity or debt financing on acceptable terms, which could negatively impact its business and financial condition[99]. Investment Activities - Cash provided by investing activities for the three months ended March 31, 2023, was $10,706 thousand, primarily from proceeds of available-for-sale securities[97]. - The company’s cash used in financing activities for the three months ended March 31, 2023, was $(66) thousand, primarily for finance lease payments[98]. - The company experienced a net decrease of $3.7 million in operating assets and liabilities for the three months ended March 31, 2023[96]. Future Outlook - The company has not generated product revenue or achieved profitability since inception and anticipates continued net losses in the foreseeable future[99]. - The company’s future capital requirements will depend on various factors, including the development and commercialization costs of future product candidates[100]. - Interest income increased to $0.9 million for the three months ended March 31, 2023, compared to $13 thousand in the same period of 2022, due to higher interest rates[92].

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].

Financial Performance - For the three months ended September 30, 2022, total operating expenses decreased by 12% to $13.6 million from $15.5 million in the same period of 2021[82]. - Operating expenses for the nine months ended September 30, 2022, were $44.8 million, a slight decrease of 1% from $45.5 million in the same period of 2021[82]. - The net loss for the nine months ended September 30, 2022, was $44.1 million, adjusted for non-cash items including stock-based compensation expense of $8.8 million[95]. - The company has not generated product revenue or achieved profitability since inception and anticipates continued net losses for the foreseeable future[98]. Research and Development - Research and development expenses for the three months ended September 30, 2022, were $9.5 million, a decrease of 4% compared to $9.9 million for the same period in 2021[82]. - Research and development expenses for the nine months ended September 30, 2022, were $31.1 million, an increase from $29.4 million in the same period of 2021, primarily due to costs related to the Phase 1 clinical trial of NL-201[85]. - The decision to discontinue NL-201 was based on a review of preliminary data and the expected benefit-to-risk ratio for patients[66]. - The company is exploring additional therapeutic candidates beyond NL-201, including a targeted activator of T-regulatory cells for inflammation and autoimmune diseases[73]. - The company is focusing on the next generation of immunotherapies using de novo protein design and advanced machine learning[65]. Cost Management - General and administrative expenses decreased by 26% to $4.1 million for the three months ended September 30, 2022, compared to $5.6 million in the same period of 2021[82]. - General and administrative expenses for the three months ended September 30, 2022, were $4.1 million, down from $5.6 million in the same period of 2021, mainly due to a decrease in personnel-related costs[87]. - For the nine months ended September 30, 2022, general and administrative expenses totaled $13.7 million, compared to $16.1 million for the same period in 2021, reflecting decreases in personnel-related and facility-related costs[88]. - The company expects cost savings from a 40% reduction in workforce and the discontinuation of NL-201 development to extend its cash runway into the second half of 2025[67]. Cash Flow and Investments - Net cash used in operating activities for the nine months ended September 30, 2022, was $34.7 million, slightly lower than $35.4 million in the same period of 2021[92]. - Cash used in investing activities for the nine months ended September 30, 2022, was $67.6 million, significantly higher than $2.9 million in the same period of 2021[94]. - As of September 30, 2022, the company had an accumulated deficit of $437.6 million and cash, cash equivalents, and short-term investments of $106.9 million[92]. - The company expects its existing cash resources to fund operations into the second half of 2025, but may need to seek additional funds sooner than planned[98]. Capital Raising - The company plans to raise substantial additional capital to support operations and growth strategy, relying on equity sales, debt financing, or collaborations[77]. Interest Income - Interest income for the three months ended September 30, 2022, was $559,000, an increase from $6,000 in the same period of 2021, attributed to higher interest rates and U.S. treasury securities purchases[91]. Work Environment - The company has transitioned to a work-from-home policy during the COVID-19 pandemic but has returned to in-office work with hybrid schedules as of the end of Q3 2022[80].

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 ...

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 ...

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].

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 ...

(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 ...

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]