On August 10, 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 second quarter of 2023 (Press release, NexImmune, AUG 10, 2023, View Source [SID1234634202]).

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"Our previously announced strategic prioritization of our injectable modality (AIM INJ) underscores our commitment to delivering on the significant potential of our artificial antigen-presenting cell (aAPC) nanoparticles to drive antigen-specific T cell function beyond cell therapy approaches and oncology. In our clinical trials with our adoptive cell therapy, we have demonstrated the ability to expand AML tumor-specific T cells with combined memory and effector functions and have observed clinical responses. Furthermore, our collaborations have generated preclinical data that highlights the potential to drive response in solid tumor indications, as well as non-malignant immunology diseases such as MS and SLE." said Kristi Jones, NexImmune’s CEO.

"Our cells exhibit potential superior potency and durability in preclinical models, combining a low dose of AIM multi-tumor expanded T cells with low doses of T-cell engaging bispecific agents, and showing synergistic tumor killing. We believe that these data support the importance of combining a "fit" multi-tumor specific T cell approach with other T cell immuno-oncology mechanisms and represent a unique opportunity to transform treatment paradigms, especially in solid tumors."

"We remain excited about advancing the injectable programs to the clinic and we are encouraged by initial dialogue with the FDA. We believe that the ability to bypass the host dendritic cell and directly engage T cells in the body provides the potential for greater specific T cell responses. Preclinical data to date has been consistent across modalities in the ability to selectively activate and expand important tumor specific T cells with cancer cell killing capacity. In autoimmune disease models, our injectable nanoparticles have been shown to selectively reduce and suppress the disease-causing T cells that reside in the lymph node and target organs in diseases such as T1D. Several manufacturing components have already been produced and process transfer plans are underway. We also continue to advance our Class II approach designed to address diseases like rheumatoid arthritis (RA) and celiac disease."
"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 immunotherapies and novel combinations and look forward to providing updates in the future."

Select Second Quarter 2023 Clinical and Business Highlights
Clinical and Preclinical Updates
AIM INJ, an injectable "Off-the-shelf" Antigen-Specific Immunotherapy, and Other Preclinical Research
•Initiated multiple preclinical studies to evaluate NEXI-100 as a monotherapy and in combination with other cancer immunotherapies to support the Company’s oncology program.
•2023 FOCIS Annual Meeting poster presentation reported AIM nanoparticle expansion of EBV-specific T-cell from healthy donors and patients with MS revealed a functional defect in the EBV response of MS patients to select antigen peptide targets, which may be a contributing factor in the pathogenesis of MS as well as other EBV related non-malignant diseases such as SLE.
•In partnership with Yale University Professor Kevan Herold and the Juvenile Diabetes Research Fund (JDRF), evaluation of AIM injectable nanoparticles in type 1 diabetes (T1D) confirmed their ability to drive T cell function in vivo as evidenced by a significant delay in the onset of spontaneous T1D that is associated with a reduction in T1D inducing memory T cells in pancreatic lymph nodes and the pancreas. Future experiments will be conducted to test the addition of suppressive and apoptotic 2nd signals to the AIM nanoparticles in addition to therapeutic combination approaches with anti-CD3 agents.
•Continued to advance neo-antigen our melanoma research collaboration with NYU Langone’s Perlmutter Cancer Center.
•Continued to work in other areas of autoimmune diseases, including vitiligo, MS, HTLV-1-associated myelopathy and others.
NEXI-001 Relapsed Refractory AML Post Allo-HSCT
•A marked increase in antigen-specific cells was observed with increasing dose levels, consistent with a dose response observation. The persistence of antigen-specific T-cells with phenotypes associated with anti-tumor effect and immunologic memory was consistently observed in blood and bone marrow.
•Phase 1 data reported at ASCO (Free ASCO Whitepaper) 2023 shows NEXI-001 is well tolerated with a favorable safety profile. An immunologic and clinical dose responses were observed. Since ASCO (Free ASCO Whitepaper), the clinical response observed in the Cohort 3 patient with poor prognosis extramedullary disease who received the highest cell dose tested (200M x 3, Cycle 1 only) has now been maintained up to nine months. As of the most recent follow-up, the patient remains asymptomatic with no evidence of disease and continues to be monitored.
Manufacturing and Regulatory:
•Transitioning the IND engine capability: Established ACT cell therapy and nanoparticle platform manufacturing to enable IND engine in blood and solid tumor indications. The Company is proactively transitioning this approach to the injectable program.
•Preparing to manufacture clinical material for the planned injectable IND: Completed clinical protein production, selected polymer vendor and the transfer activities to our CDMO are underway to support the planned submission of an IND for NEXI-101 (injectable) in 2H2024.
Select Second Quarter 2023 Financial Highlights
Cash and cash equivalents for the Company as of June 30, 2023 were $16.3 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 $4.9 million in the second quarter of 2023, compared to $11.8 million for the same period in the prior year. The decrease of $6.9 million was due primarily to the completion of preclinical manufacturing work, pausing of clinical trials, and reduction in personnel-related expenses resulting from terminations.

General and administrative expenses were $2.9 million, compared to $4.1 million for the same period in the prior year. The decrease was primarily due to decreases in legal and other administrative fees expenses and in personnel-related expenses.

Net loss, according to U.S. generally accepted accounting principles in the, or GAAP, was $7.6 million for the quarter, or a basic and diluted GAAP net loss per share of $0.29. This compares to a net loss of $15.9 million, or a basic and diluted GAAP net loss per share of $0.69, for the same period in the prior year.