On May 15, 2023 NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells in oncology, autoimmune and infectious diseases, reported financial results for the first quarter 2023 (Press release, NexImmune, MAY 15, 2023, View Source [SID1234631733]).
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"This is an exciting time for NexImmune, as we remain focused on progressing the development of novel approaches in the field of immunotherapy," said Kristi Jones, NexImmune’s CEO. "Interest in antigen specific approaches for oncology, autoimmune disorders and infectious diseases has never been higher. We believe our AIM INJ direct injectable nanoparticle platform offers a unique and powerful solution to direct a multi-antigen specific T cell response in a scalable "off the shelf" approach across these disease areas. We continue to move our INJ "off the shelf" lead program forward in oncology and are encouraged by our conversations with the FDA."
"I am also pleased that our NEXI-001 phase 1 clinical data in cell therapy has been accepted for presentation at ASCO (Free ASCO Whitepaper) and I look forward to reviewing this data, as well as the preclinical data across oncology, autoimmune and infectious disease areas for our "off the shelf" injectable this year."
"We remain confident in the potential therapeutic benefit of our AIM platform-based product candidates and their ability to significantly impact the emerging, rapidly moving field of antigen specific immuno-oncology therapies, novel IO/IO combinations, autoimmune disorders and virally-driven diseases."
Select First Quarter 2023 Clinical and Business Highlights
Clinical and Preclinical Updates
AIM INJ, Injectable "Off-the-shelf" Antigen-Specific Immunotherapy, and Other Preclinical Research
•Initiated multiple preclinical studies to evaluate as a monotherapy and in combination with a checkpoint inhibitor to support the Company’s oncology program
•Continue to evaluate AIM INJ nanoparticles as a therapeutic for type 1 diabetes as well as other autoimmune diseases with Yale University Professor Kevan Herold in partnership with JDRF
•Poster presented at 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR demonstrated evidence that AIM multi-antigen specific cells combined with a BCMA bispecific results in superior potency, enhanced persistence and durability in multiple myeloma models
•Publication in Frontiers in Medicine highlighted the potential ability of NexImmune’s AIM platform to treat viral diseases
•Announced research collaboration with the National Institute of Neurological Disorders and Stroke of the National Institutes of Health, with an initial focus on multiple sclerosis
•Announced neo-antigen melanoma research collaboration with NYU Langone’s Perlmutter Cancer Center
•Continued work in other areas of autoimmune diseases; including vitiligo, multiple sclerosis, pemphigus, HTLV-1-associated myelopathy and others.
NEXI-001 Relapsed Refractory AML Post Allo-HSCT
•Full enrollment and dosing of the final safety cohort of NEXI-001 completed
•Plan to announce data at ASCO (Free ASCO Whitepaper) 2023
•Continued to explore opportunities to advance NEXI-001 with potential collaborators and investigators
NEXI-003 HPV-Related Cancers
•Continued to explore opportunities to develop this adoptive cell therapy with external partners and collaborators and develop a corporate HPV strategy that utilizes the AIM INJ modality.
Select First Quarter 2023 Financial Highlights
Cash and cash equivalents for the Company as of March 31, 2023 were $22.3 million compared to $34.6 million at December 31, 2022. Based upon current operating plans, NexImmune expects that its existing cash and cash equivalents will enable the Company to fund its operating and capital expenditure requirements into the fourth quarter of 2023.
Research and development expenses were $6.1 million in the first quarter of 2023, compared to $10.4 million for the same period in the prior year. The decrease of $4.3 million was due primarily to the completion of preclinical manufacturing work and the pausing of the clinical trials.
General and administrative expenses were $3.7 million, compared to $4.6 million for the same period in the prior year. The decrease was primarily due to decreases in personnel-related expenses and in legal and other administrative fees expenses.
Net loss, according to generally accepted accounting principles in the U.S. GAAP, was $9.6 million for the quarter, or a basic and diluted GAAP net loss per share of $0.37. This compares to a net loss of $15.0 million, or a basic and diluted GAAP net loss per share of $0.66, for the same period in the prior year.