On August 9, 2021 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 financial results for the second quarter of 2021 (Press release, NexImmune, AUG 9, 2021, View Source [SID1234586132]).

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!

"The first half of the year was a very productive period for the company. We are focused on completing enrollment in our Phase I/II clinical trials for NEXI-001 and NEXI-002 and expect to present additional clinical data for each during scientific conferences toward the end of this year," said Scott Carmer, Chief Executive Officer. "We are also excited to announce our first indication in solid tumors and expect to submit our IND for HPV-associated malignancies in the second quarter of 2022. Additionally, we’ve initiated IND-enabling pre-clinical experiments that will be the basis for multiple IND submissions in support of our injectable nanoparticle (AIM INJ). This progress highlights the promise of our AIM platform across disease areas and delivery modalities, and we look forward to providing further updates on these important programs later this year."

Select 2Q 2021 Clinical and Business Highlights

Clinical and Preclinical Updates

NEXI-001

Abstract presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting in June 2021 highlights safety, tolerability, immune responses and early clinical activity in all patients evaluated
Dose Level 2 (single infusion of 200M cells/month x two cycles) is fully enrolled
Dose Level 3 (single infusion of 200M cells/week for three weeks x two cycles) is enrolling
Treatment-related adverse events, including infusion reactions, GVHD, CRS, and neurotoxicity (ICANS), have not been observed in patients who received NEXI-001 at Dose Level 1 and Dose Level 2, either as single or repeat infusions
Further data expected to be announced during the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021
NEXI-002

Abstract presented at European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting in May 2021 highlights safety, tolerability and immune responses in all patients evaluated
Safety cohort completed and expansion phase is enrolling
Treatment-related adverse events, including infusion reactions, CRS, and neurotoxicity (ICANS), have not been observed in patients who received NEXI-002
Further data expected to be announced during the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021
NEXI-003

First solid tumor clinical trial for multi-antigen autologous AIM ACT product will target HPV-associated malignancies
Preclinical data validating the selection of multiple immunogenic HPV antigen peptides expected to be announced during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting (SITC 2021) in November 2021
Investigational new drug (IND) submission planned for 2Q 2022
Other R&D

IND-enabling preclinical studies for the AIM INJ platform continue; abstract presentations planned for SITC (Free SITC Whitepaper) 2021 in November 2021
First collaboration in autoimmune diseases announced with Yale University to evaluate AIM INJ nanoparticles in Type 1 diabetes
Business Updates

Announced formation of the company’s Scientific Advisory Board
Announced the appointments of Dr. Jack Ragheb, SVP, Translational Medicine, and Matthew Schiller, Head of Business Development
Select 2Q 2021 Financial Highlights

Cash, cash equivalents and marketable securities for the company as of June 30, 2021 were $102.8M compared to $118.1M for quarter ending March 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 through the third quarter of 2022.

Research and development expenses were $8.1M in the second quarter of 2021, compared to $4.2M 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 $4.0M, compared to $2.6M for the same period the prior year. 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 $12.2M for the quarter, or a basic and diluted GAAP loss per share of $0.54. This compared to a net loss of $6.9M, or a basic and diluted GAAP loss per share of $6.17, for the same period the prior year.