On March 9, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported its fourth quarter and full year financial results for the full year 2021 (Press release, NexImmune, MAR 9, 2022, View Source [SID1234609841]).

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"2021 was a landmark year for NexImmune and the continued development of our AIM platform technology," said Kristi Jones, Chief Executive Officer. "The funding received from our successful IPO in February of 2021 has allowed us to advance Phase 1/2 clinical trials for NEXI-001 and NEXI-002 and other programs towards the clinic. We plan to provide a clinical update for the NEXI-001 trial in AML during the second half of 2022, as well as provide an update on our expansion cohort in the NEXI-002 trial in relapsed / refractory multiple myeloma. Additionally, we have identified our antigen peptide targets to be included in our first solid tumor IND application for HPV-associated malignancies and expect to file our IND in the first half of this year. We will also be providing an update on AIM INJ direct injectable modality as we continue our IND enabling work. These updates will include preclinical data supporting an IND in oncology and data from our research collaboration with the lab of Professor Kevan Herold at Yale University, which explores the effects of our AIM injectable nanoparticle as a therapeutic for type 1 diabetes. Despite the challenges the biotech market has experienced over the last months, our team continues to execute on all fronts and we remain on track to achieve our key catalysts for 2022."

Select Fourth Quarter and Full Year 2021 Clinical and Business Highlights

Clinical and Preclinical Updates

NEXI-001

Robust immune responses with signs of clinical activity across all dose levels to date
NEXI-001 continues to be well tolerated across all dose levels administered to date, with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Due to the favorable emerging clinical profile, plans are underway to expand the addressable population with an additional study arm to include patients with haplo-identical donors
Updated clinical results are expected to be announced in the second half of 2022
NEXI-002

Safety cohort completed and expansion phase continues to enroll and dose
NEXI-002 continues to be well tolerated with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Further clinical data from the Phase 1/2 trial are expected to be announced in the second half of 2022
NEXI-003

Preclinical data supporting the selection of multiple immunogenic antigen peptides commonly expressed on HPV-associated tumors was presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting (SITC 2021) in November 2021
Finalized antigen selection for NEXI-003 and manufactured nanoparticles for clinical trials
Investigational New Drug (IND) submission planned for the first half of 2022
Injectable AIM-np and other Preclinical

First collaboration in autoimmune diseases announced with Yale University Professor Kevan Herold to evaluate AIM INJ nanoparticles as a therapeutic for Type 1 diabetes to suppress or eliminate antigen specific autoreactive T cells
Advancing in vivo work for other areas of development in autoimmune, oncology and infectious disease
Announced research collaboration with Rutgers, The State University of New Jersey, for neuroendocrine tumor checkpoint targets, which may also have utility in other cancers
Business Updates

Completed successful $126.5M IPO in February 2021
Announced the appointment of Kristi Jones as Chief Executive Officer and Member of the Board of Directors
Announced the formation of the Scientific Advisory Board and the Autoimmune and Infectious Diseases Advisory Board
Continued to strengthen the management team with key appointments across the organization
Select 4Q and Full 2021 Financial Highlights

Cash, cash equivalents and marketable securities for the company as of December 31, 2021 were $81.8 million compared to $5.0 million at December 31, 2020. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its operating and capital expenditure requirements into the second quarter of 2023.

Research and development expenses were $12.0 million in the fourth quarter ended December 31, 2021, compared to $4.4 million for the same period in the prior year. Research and development expenses were $37.5 million for the full year period ended December 31, 2021, an increase of $19.7 million compared to $17.8 million for the full year ended December 31, 2020. The increase in R&D expenses was mainly attributable to costs for research related to preclinical manufacturing and the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $3.5 million for the fourth quarter ended December 31, 2021, an increase of $0.9 million compared to $2.6 million for the same period in the prior year. General and administrative expenses were $15.8 million for the full year period ended December 31, 2021, an increase of $5.8 million compared to $10.0 million for the full year ended December 31, 2020. The increase was due primarily to increases in headcount and fees related to professional and consulting services.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $15.4 million for the quarter and $50.9 million for the full year 2021, or a basic and diluted GAAP loss per share of $0.68 and $2.54 respectively. This compared to a net loss of $33.1 million, or a basic and diluted GAAP loss per share of $26.42, for the same period the prior year.