On August 5, 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 second quarter ended June 30, 2021 and provided a midyear corporate update (Press release, Neoleukin Therapeutics, AUG 5, 2021, View Source [SID1234585874]).

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!

"Our progression to a clinical stage company is a significant milestone, and we remain focused on execution of our clinical development strategy and pipeline expansion as we advance and explore the potential of our de novo protein technology platform," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin.

Recent Updates
NL-201
NL-201 is Neoleukin’s lead de novo protein therapeutic candidate, 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.

In May 2021, Neoleukin announced dosing of the first patient in a Phase 1 trial of NL-201. The Phase 1 study, underway at clinical sites in the U.S. and Australia, is enrolling 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. While certain factors, including COVID-19, have had an impact on site activation for our Phase 1 trial of NL-201, we are accelerating site start-up activities to increase the pace of enrollment. Interim data from the ongoing systemic Phase 1 trial of NL-201 is currently anticipated in 2022.

In addition, Neoleukin is assessing plans for a local administration study of NL-201 while prioritizing the NL-201 systemic trial. Management will update timing for future trials as appropriate.

NL-CVX1
NL-CVX1 is a de novo protein that binds to the spike protein of SARS-CoV-2, the virus that causes COVID-19 and blocks infection of human cells. The design and characterization of NL-CVX1 in under three months underscores the speed and versatility of Neoleukin’s de novo protein platform.
In June 2021, in response to the evolving COVID-19 therapeutic landscape, including the widespread availability of effective vaccines, Neoleukin suspended plans to advance this research program into clinical trials.
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 discuss its de novo protein pipeline during the second half of 2021.
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled $164.2 million as of June 30, 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 second quarter of 2021 increased to $9.8 million from $4.8 million for the second quarter of 2020. The increase was primarily due to increased expenses incurred from IND-enabling and clinical trial 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 second quarter of 2021 increased to $5.3 million from $4.9 million for the second quarter of 2020. The increase in general and administrative expenses was primarily due to increases in personnel-related costs as Neoleukin continues to grow its operations. The increase was partially offset by higher costs incurred in the second quarter of 2020 associated with the termination of its Vancouver, Canada office lease.
Net Loss: Net loss for the second quarter of 2021 was $15.1 million compared to a net loss of $9.7 million in the second quarter of 2020.