On May 12, 2021 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, 2021 and provided a corporate update (Press release, Neoleukin Therapeutics, MAY 12, 2021, View Source [SID1234579797]).
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"The first quarter of 2021 saw continued progress in expanding our de novo protein capabilities, preparing for clinical testing of NL-201, and appointing Priti Patel as Chief Medical Officer," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "It is exciting to begin enrolling patients in the NL-201 Phase 1 clinical trial and to become a clinical stage company."
Recent Updates
NL-201 Phase 1 Trial Underway
In May 2021, Neoleukin announced dosing of the first patient in a Phase 1 trial of NL-201.
NL-201 is a de novo protein that is designed to mimic the therapeutic activity of natural cytokines IL-2 and IL-15, while potentially reducing the toxicities associated with high-dose IL-2. The Phase 1 study is planned to enroll up to 120 patients with advanced, relapsed, or refractory solid tumors. Patients will receive NL-201 as intravenous monotherapy to assess safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity. The Phase 1 study will be conducted at multiple sites in Australia and North America.
In addition to the systemic trial, Neoleukin is planning a trial of NL-201 to test local administration in order to achieve higher drug concentrations in the tumor microenvironment. Neoleukin expects the local administration trial to begin by the end of 2021.
De Novo Protein Design for Coronavirus – NL-CVX1
NL-CVX1 is a decoy protein that binds to the spike protein of SARS-CoV-2, the virus that causes COVID-19, and is designed to be resilient to viral mutational escape. In preclinical studies, NL-CVX1 protected Syrian hamsters from a lethal dose of SARS-CoV-2 after intranasal administration. Neoleukin is evaluating a potential first-in-human trial of NL-CVX1, and will continue to assess the program as the SARS-CoV-2 landscape evolves.
Other Research Updates
Neoleukin has multiple research projects underway evaluating the applications of de novo protein technology to develop agonists and antagonists of immune pathways. Neoleukin currently plans to announce additional information about its pipeline program during the second half of 2021.
Executive Appointment
In May 2021, Neoleukin announced the appointment of Priti Patel, M.D., M.S., as Chief Medical Officer. Dr. Patel joins Neoleukin from AstraZeneca, where she served as Vice President, Head of Hematology Clinical Development since 2019. Previously, she served as Senior Medical Director and Executive Medical Director at Acerta Pharma before its acquisition by AstraZeneca, and as Medical Director at Onyx Pharmaceuticals (acquired by Amgen).
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled $178.4 million as of March 31, 2021, compared to $192.6 million as of December 31, 2020.
Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations into 2023.
R&D Expenses: Research and development expenses for the first quarter of 2021 increased to $9.7 million from $5.5 million for the first quarter of 2020. The increase was primarily due to increased expenses incurred from IND-enabling and clinical trial startup activities related to Neoleukin’s lead product candidate, NL-201, and in connection with the advancement of other Neoleukin technologies.
G&A Expenses: General and administrative expenses for the first quarter of 2021 increased to $5.2 million from $3.6 million for the first quarter of 2020. The increase in general and administrative expenses was primarily due to increases in personnel-related costs and professional service fees as Neoleukin continues to grow its operations, along with facility related costs associated with the build-out of its new headquarters in Seattle, Washington.
Net Loss: Net loss for the first quarter of 2021 was $14.9 million compared to a net loss of $8.6 million in the first quarter of 2020 primarily due to Neoleukin’s focus on its lead candidate, NL-201, and its de novo protein platform.