On May 12, 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 financial results for the first quarter of 2022 (Press release, NexImmune, MAY 12, 2022, View Source [SID1234614529]).
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"This quarter, we have continued to execute on our clinical and corporate strategy, taking the necessary steps to achieve our upcoming catalysts for the remainder of this year," said Kristi Jones, Chief Executive Officer. "We remain on track to provide a clinical update for the NEXI-001 trial in AML during the second half of 2022, and to provide an update on the expansion cohort in the NEXI-002 trial in relapsed / refractory multiple myeloma. We also plan to file our first solid tumor IND application for HPV-associated malignancies in the near term. In parallel, we are advancing IND-enabling work for our AIM injectable modality and expect to provide updates on preclinical data for oncology and autoimmune indications throughout the second half of the year. With our new target discovery collaborations, we are well-positioned to leverage our modular AIM platform for efficient and rapid new product development. Overall, I am excited with our progress and focus on execution to deliver on upcoming catalysts."
First Quarter 2022 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
Enrollment continues, and updated clinical results are expected to be announced in the second half of 2022
NEXI-002
Expansion phase is ongoing
In this heavily pre-treated population, evidence of immune response and signals clinical activity have been observed. NEXI-002 continues to be well tolerated with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Manufacturing achieved higher final cell count yield in recent products by adjusting prior treatment washout period, updating cell collection guidance and other process adjustments
Further clinical data from the Phase 1/2 trial are expected in the second half of 2022
NEXI-003
Preclinical data supporting the selection of multiple immunogenic antigen peptides commonly expressed on HPV-associated tumors and a cancer survival antigen 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 nanoparticle programs and other preclinical research
Advanced in vivo and preclinical work to support the development of AIM injectable nanoparticles as a therapeutic in oncology and autoimmune diseases
Advanced work with Yale University Professor Kevan Herold to evaluate AIM INJ nanoparticles for type 1 diabetes. A JDRF grant award will support the collaboration
Announced a strategic partnership with Zephyr AI in oncology for novel target discovery and validation to support target selection for potential future products candidates
Announced research collaboration with Rutgers, The State University of New Jersey, for neuroendocrine tumor checkpoint targets, which may have utility in other cancers
Announced research collaboration with NYU Langone Perlmutter Cancer Center for melanoma neo-antigen-specific CD8+ T cell expansion using the AIM platform technologies
Announced a preclinical research collaboration with Columbia University Irving Medical Center’s Herbert Irving Comprehensive Cancer Center focused on NexImmune’s AIM ACT in Columbia’s patient-derived organoid models of HPV-associated cancers
Business Updates
Announced the appointment of Kristi Jones as Chief Executive Officer and Member of the Board of Directors
Announced the promotion of Mathias Oelke, Ph.D. to Chief Scientific Officer
Announced the appointment of Dr. Leena Gandhi, Director of Dana-Farber’s Center for Cancer Therapeutic Innovation, to NexImmune’s Board of Directors
Announced the formation of the Autoimmune and Infectious Diseases Scientific Advisory Board
Continued to strengthen the management team with key appointments across the organization
Select 1Q 2022 Financial Highlights
Cash, cash equivalents and marketable securities for the Company as of March 31, 2022 were $65.0 million compared to $81.8 million for quarter ending December 31, 2021. 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 $10.4 million in the first quarter of 2022, compared to $6.0 million for the same period in the prior year. The increase in R&D expenses was mainly attributable to costs for the two clinical trials, as well as personnel-related expenses driven by increased headcount.
General and administrative expenses were $4.6 million, compared to $4.1 million for the same period the prior year. The increase was due primarily to personnel-related expenses and fees related to professional and consulting services.
Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $15.0 million for the quarter, or a basic and diluted GAAP loss per share of $0.66. This compared to a net loss of $8.5 million, or a basic and diluted GAAP loss per share of $0.71, for the same period the prior year.