On May 9, 2022 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported financial results for the quarter ending March 31, 2022 and provided a corporate update (Press release, Neoleukin Therapeutics, MAY 9, 2022, View Source [SID1234613923]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"During the first quarter of 2022 our dedicated team at Neoleukin has been focused on execution of our NL-201 Phase 1 clinical trial, evaluating multiple schedules during dose escalation in patients with relapsed and refractory solid tumors," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "We anticipate reporting interim data from this trial during the second half of 2022; we also expect to initiate testing of NL-201 in combination with pembrolizumab around mid-year. Our scientists continue preclinical evaluation of NL-201 in novel regimens and additional indications as well as advancing our de novo protein technology and early-stage research programs."
NL-201 Update
Neoleukin is conducting a clinical trial of intravenous NL-201 in patients with advanced solid tumors. It is currently enrolling patients at sites in Australia, the United States, and Canada, evaluating two different schedules and multiple dose levels in order to determine a recommended Phase 2 dose and schedule. Neoleukin anticipates disclosing interim data during the second half of 2022.
In January, Neoleukin announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) to evaluate NL-201 plus pembrolizumab as part of Neoleukin’s ongoing Phase 1 trial in patients with advanced solid tumors. This additional arm of the ongoing clinical trial is expected to begin enrollment mid-year 2022.
In April 2022, Neoleukin announced the presentation of preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, highlighting the potential for NL-201 to treat non-Hodgkin lymphoma as well as synergistic antitumor activity when NL-201 is combined with radiation therapy, including significant inhibition of tumor growth and increased survival in preclinical models.
Based on encouraging preclinical activity, Neoleukin announced plans to initiate a separate clinical trial to evaluate NL-201 in patients with hematologic malignancies. The timing for enrolling patients in this trial will be determined based on data we receive from our ongoing solid tumor Phase 1 trial relating to safety and optimal dosing schedules.
Executive Appointment
In March 2022, Neoleukin announced the appointment of Donna M. Cochener as General Counsel, Senior Vice President, Legal. Ms. Cochener joins Neoleukin after serving as Senior Vice President, Deputy General Counsel at HomeStreet, Inc., the parent company of HomeStreet Bank. Prior to her position with HomeStreet, Ms. Cochener was a partner at Davis Wright Tremaine, LLP in Seattle, and worked as an associate at the Seattle offices of Heller Ehrman, LLP, Riddell Williams, P.S. and Perkins Coie, LLP.
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled $128.1 million as of March 31, 2022, compared to $142.5 million as of December 31, 2021.
Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations through 2023.
R&D Expenses: Research and development expenses for the quarter ended March 31, 2022 increased to $10.7 million from $9.7 million for the quarter ended March 31, 2021. The increase was primarily due to increased clinical trial expenses related to our lead product candidate, NL-201, and costs incurred in connection with the advancement of other Neoleukin technologies. The increase was partially offset by higher costs incurred during the three months ended March 31, 2021 in connection with the build-out of our headquarters and laboratory space in Seattle, Washington, as well as development costs associated with our NL-CVX1 program which was suspended in June 2021.
G&A Expenses: General and administrative expenses for the quarter ended March 31, 2022 decreased to $4.7 million from $5.2 million for the quarter ended March 31, 2021. The decrease was primarily attributable to decreases in personnel-related and facility-related costs.
Net Loss: Net loss for the quarter ended March 31, 2022 was $15.4 million compared to a net loss of $14.9 million for the quarter ended March 31, 2021.
About NL-201
NL-201 is a de novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models.