NEXI NexImmune Inc.

3.04
-0.31  -9%
Previous Close 3.35
Open 3.25
52 Week Low 3.17
52 Week High 28
Market Cap $69,042,191
Shares 22,711,247
Float 17,676,436
Enterprise Value $-32,909,967
Volume 108,782
Av. Daily Volume 55,062
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Upcoming Catalysts

Drug Stage Catalyst Date
NEXI-001
Acute Myeloid Leukemia (AML) / Myelodysplastic Syndrome (MDS) after allogeneic HCT
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
NEXI-002
Multiple Myeloma
Phase 1/2
Phase 1/2
Phase 1/2 preliminary data presented at EHA meeting June 2021. Phase 1/2 data reported that treatment is well-tolerated without dose-limiting toxicities, noted December 12, 2021.

Latest News

  1. GAITHERSBURG, Md., Jan. 18, 2022 (GLOBE NEWSWIRE) -- 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, today announced that Scott Carmer, Chief Executive Officer, will participate in the LLS TAP panel discussion entitled "Expanding the Possible with Next Generation Cell Therapies" on Friday, January 21, 2022 at 12:00 p.m. Eastern Time.

    The webcast will be accessible on the Investor Relations page of NexImmune's website at Events and Presentations | NexImmune, Inc. Participants may also register at LLS TAP: Expanding the Possible with Next-Generation Cell Therapies.

    LLS…

    GAITHERSBURG, Md., Jan. 18, 2022 (GLOBE NEWSWIRE) -- 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, today announced that Scott Carmer, Chief Executive Officer, will participate in the LLS TAP panel discussion entitled "Expanding the Possible with Next Generation Cell Therapies" on Friday, January 21, 2022 at 12:00 p.m. Eastern Time.

    The webcast will be accessible on the Investor Relations page of NexImmune's website at Events and Presentations | NexImmune, Inc. Participants may also register at LLS TAP: Expanding the Possible with Next-Generation Cell Therapies.

    LLS and NexImmune have a long history of working together. In October 2017, NexImmune benefitted from an initial TAP investment and in 2021 received a second investment as part of the Company's initial public offering to support NexImmune's ongoing Phase 1/2 studies in AML/MDS and multiple myeloma.

    "We are excited with our continued support of NexImmune and their participation in this panel. The LLS track record in accelerating lifesaving blood cancer treatments is unparalleled," said Lee Greenberger, Ph.D., LLS Chief Scientific Officer. "The continuity of our funding from preclinical through clinical research demonstrates our commitment to supporting innovative therapies as they move from the laboratory into practice."

    About NexImmune

    NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body's own T cells to generate a specific, potent, and durable immune response. The backbone of NexImmune's approach is a proprietary Artificial Immune Modulation (AIM™) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. AIM constructed nanoparticles employ natural biology to engage, activate and expand endogenous T cells in ways that combine anti-tumor attributes of antigen-specific precision, potency and long-term persistence with reduced potential for off-target toxicities.

    NexImmune's two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

    For more information, visit www.neximmune.com.

    About The Leukemia & Lymphoma Society and Therapy Acceleration Program® (TAP)

    The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against cancer. The LLS mission is to cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS TAP is a strategic initiative that builds business alliances and collaborations with biotechnology companies and academic researchers to identify potential breakthrough therapies with the ability to change the standard of care. LLS TAP funds late-stage pre-clinical studies, and proof of concept or registrational clinical trials to help advance therapeutics along the drug development and approval pathway. To learn more, visit www.LLS.org/tap. Follow LLS on Facebook, Twitter, and Instagram.

    Forward Looking Statements

    This press release may contain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NexImmune, Inc. (the "Company"). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning our planned and ongoing clinical studies for the Company's product candidates, including NEXI-001 and NEXI-002; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; and the utility of prior preclinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission ("SEC") on March 31, 2021, and subsequent reports that we file with the SEC. Forward-looking statements represent the Company's beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

    Contacts

    Investors:

    Chad Rubin, SVP, Corporate Affairs

    NexImmune, Inc.

    646.319.3261

     



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  2. GAITHERSBURG, Md., Jan. 05, 2022 (GLOBE NEWSWIRE) -- 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, today announced the formation of its Autoimmune and Infectious Disease Scientific Advisory Board (AI & ID SAB). The AI & ID SAB is comprised of distinguished academic and industry leaders in the fields of autoimmune and infectious diseases, translational research, immunology and T cell biology.

    "As we continue to advance our AIM nanotechnology platform, we are grateful to have the input and guidance of these established experts," said Jerry Zeldis, NexImmune's EVP of R&D…

    GAITHERSBURG, Md., Jan. 05, 2022 (GLOBE NEWSWIRE) -- 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, today announced the formation of its Autoimmune and Infectious Disease Scientific Advisory Board (AI & ID SAB). The AI & ID SAB is comprised of distinguished academic and industry leaders in the fields of autoimmune and infectious diseases, translational research, immunology and T cell biology.

    "As we continue to advance our AIM nanotechnology platform, we are grateful to have the input and guidance of these established experts," said Jerry Zeldis, NexImmune's EVP of R&D. "Their combined experience in autoimmune and infectious diseases, translational science and clinical development will help make informed decisions as we expand our pipeline and explore new therapeutic areas."

    NexImmune's AI and ID SAB members include:

    Gerald (Jerry) Nepom, MD, PhD (Chair), Director, Immune Tolerance Network; Member Benaroya Research Institute at Virginia Mason (Seattle); Professor (Affil) Department of Immunology, University of Washington School of Medicine.

    David Hafler, MD, William S. and Lois Stiles Edgerly Professor of Neurology; Professor of Immunology and Chairman, Department of Neurology, Yale University School of Medicine; Neurologist-in-Chief, Yale New Haven Hospital; Visiting Scientist, Broad Institute of MIT and Harvard.

    Kevan Herold, MD, C.N.H. Long Professor of Immunobiology and of Medicine (Endocrinology), Yale University; Deputy Director, Yale Center for Clinical Investigation; Co-Director, Yale Diabetes Center.

    James Krueger, MD, PhD, Chief Executive Officer, Co-director for the Center for Clinical and Translational Science, Senior Attending Physician, D. Martin Carter Professor in Clinical Investigation and Laboratory Head of Investigative Dermatology, The Rockefeller University Hospital.

    Robin Robinson, PhD, Chief Scientific Officer, RenovaCare, Inc.; former Director, Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Dept. of Health and Human Services.

    Robert Siliciano, MD, PhD, Professor of Infectious Diseases, Johns Hopkins Medical Institute; Investigator, Howard Hughes Medical Institute.

    Jeffrey (Jeff) S. Weber, MD, PhD, Deputy Director and Head, Experimental Therapeutics, Co-Director of the Melanoma Research Program, Laura and Isaac Comprehensive Perlmutter Cancer Center at NYU Langone Health; Professor of Medicine, NYU Grossman School of Medicine.

    For more information, visit https://neximmune.com/our-company/autoimmune-and-infectious-diseases-sab/

    About NexImmune

    NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body's own T cells to generate a specific, potent, and durable immune response. The backbone of NexImmune's approach is a proprietary Artificial Immune Modulation (AIM™) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. AIM constructed nanoparticles employ natural biology to engage, activate and expand endogenous T cells in ways that combine anti-tumor attributes of antigen-specific precision, potency, and long-term persistence with reduced potential for off-target toxicities.

    NexImmune's two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to 3 or more prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

    For more information, visit www.neximmune.com.

    Forward Looking Statements

    This press release may contain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NexImmune, Inc. (the "Company"). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning our planned and ongoing clinical studies for the Company's product candidates, including NEXI-001 and NEXI-002; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; and the utility of prior preclinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission ("SEC") on March 31, 2021, and subsequent reports that we file with the SEC. Forward-looking statements represent the Company's beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

    Contacts

    Investors:

    Chad Rubin, SVP Corporate Affairs

    NexImmune, Inc.

    646.319.3261



    Primary Logo

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    • Initial Phase 1/2 data presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition
    • Phase 1/2 study of NEXI-002 as a monotherapy in patients with relapsed/refractory multiple myeloma patients who have failed ≥3 prior lines of therapy is ongoing

    GAITHERSBURG, Md., Dec. 12, 2021 (GLOBE NEWSWIRE) -- 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, today announced preliminary Phase 1/2 results from an ongoing study of NEXI-002, a patient-derived multi-antigen-specific CD8+ T cell treatment for patients with relapsed/refractory multiple myeloma who…

    • Initial Phase 1/2 data presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition
    • Phase 1/2 study of NEXI-002 as a monotherapy in patients with relapsed/refractory multiple myeloma patients who have failed ≥3 prior lines of therapy is ongoing

    GAITHERSBURG, Md., Dec. 12, 2021 (GLOBE NEWSWIRE) -- 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, today announced preliminary Phase 1/2 results from an ongoing study of NEXI-002, a patient-derived multi-antigen-specific CD8+ T cell treatment for patients with relapsed/refractory multiple myeloma who have failed ≥3 prior lines of therapy. The data on low doses of NEXI-002, presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, showed a promising safety and tolerability profile and evidence of immunologic and clinical activity.

    Poster Presentation:

    Title: Preliminary Analysis of a Phase 1/2 Study of NEXI-002 Autologous Multi-Antigen-Specific CD8+ T cells for the Treatment of Relapsed or Refractory Multiple Myeloma (RRMM)

    Abstract Number: 2824

    Category: Poster Presentation

    Authors: Maung Myo Htut, MD, Juan C. Varela, MD, PhD, Vineetha Edavana, PhD, Emily Lu, PhD, Sojung Kim, PhD, Lauren Suarez, PhD, Mathias Oelke, PhD, Daniel Bednarik, PhD, Robert D. Knight, MD, and, Andrew Kin, MD

    Date & Time: Sunday, December 12, 2021; Poster Hall Hours 6-8 pm EST

    In this heavily pre-treated patient group (n=6 with an average of 7.6 lines of prior therapy), the clinical data suggests that NEXI-002 is well-tolerated without dose-limiting toxicities (no grade ≥3 CRS or any grade of ICANS). Biomarker data show that the NEXI-002 product candidate contains CD8+ antigen-specific T cells with key memory phenotypes which, after administration, are detected in peripheral blood and bone marrow of treated individuals and proliferate and persist over time. Furthermore, TCR sequencing shows that the NEXI-002 product candidate contains CD8+ T cell clones that were undetectable in the peripheral blood of the patients at baseline and which expand in both blood and bone marrow over time. After receiving lymphodepleting therapy followed by NEXI-002 infusion, patients experienced rapid lymphocyte recovery with reconstitution of both CD4+ and CD8+ T cell subtypes. Despite the infusion of very low numbers of NEXI-002 T cells (4-10x10e6 total T cells), these heavily pre-treated patients achieved stable disease for 2 to 3.5 months of duration. Importantly, despite receiving an average of 7.6 previous lines of therapy, the quality, functionality and in vivo persistence of all patient-derived NEXI-002 T cell products were comparable to those expanded from healthy donors. Strategies to yield higher product doses are underway, including evaluating patients with lower disease burden plasma cell dyscrasias.

    "We are very encouraged by the initial Phase 1/2 results observed to-date with NEXI-002," said Scott Carmer, CEO of NexImmune. "We have now shown, in two separate clinical trials using apheresis material from either healthy donors or heavily pre-treated patients, that we can manufacture CD8+ T cell products with high target antigen specificity and with T cell phenotypes that promote in vivo proliferation, persistence and anti-tumor activity. Even at the very low doses of NEXI-002 administered in this ongoing trial, we've seen robust biomarker and immunological responses with evidence of clinical activity. These preliminary data provide further evidence of the NEXI-002 mechanism of action, and we are eager to continue assessing NEXI-002's potential in this patient population and in additional patients with lower-disease-burden plasma cell dyscrasias."

    About NexImmune

    NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body's own T cells to generate a specific, potent, and durable immune response. The backbone of NexImmune's approach is a proprietary Artificial Immune Modulation (AIM™) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. AIM constructed nanoparticles employ natural biology to engage, activate and expand endogenous T cells in ways that combine anti-tumor attributes of antigen-specific precision, potency and long-term persistence with reduced potential for off-target toxicities.

    NexImmune's two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to 3 or more prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

    For more information, visit www.neximmune.com.

    Forward Looking Statements

    This press release may contain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NexImmune, Inc. (the "Company"). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning our planned and ongoing clinical trials for the Company's product candidates, including NEXI-001 and NEXI-002; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical trials; the Company's beliefs and expectations regarding the preliminary results from the Phase 1/2 clinical trial of NEXI-002; and the utility of prior preclinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission ("SEC") on March 31, 2021, and subsequent reports that we file with the SEC. Forward-looking statements represent the Company's beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

    Contacts

    Investors and Media:

    Chad Rubin, SVP Corporate Affairs

    NexImmune, Inc.



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    • Advancing two lead product candidates in Phase 1/2 clinical trials
    • Additional clinical and preclinical data anticipated by year end 2021 and first half 2022
    • Announced collaboration with Yale University Department of Immunobiology to explore use of AIM INJ in regard to regulation of Type 1 Diabetes

    GAITHERSBURG, Md., Nov. 12, 2021 (GLOBE NEWSWIRE) -- 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, today reported its financial results for the third quarter of 2021.

    "We had another strong quarter as characterized by our continued progress developing the AIM technology platform…

    • Advancing two lead product candidates in Phase 1/2 clinical trials
    • Additional clinical and preclinical data anticipated by year end 2021 and first half 2022
    • Announced collaboration with Yale University Department of Immunobiology to explore use of AIM INJ in regard to regulation of Type 1 Diabetes

    GAITHERSBURG, Md., Nov. 12, 2021 (GLOBE NEWSWIRE) -- 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, today reported its financial results for the third quarter of 2021.

    "We had another strong quarter as characterized by our continued progress developing the AIM technology platform," said Scott Carmer, Chief Executive Officer. "Our primary focus remains on completing enrollment in our Phase I/II clinical trials for NEXI-001 and NEXI-002. We plan to provide clinical updates for the NEXI-001 trial in AML during the first half of 2022 and will update the NEXI-002 trial in relapsed / refractory multiple myeloma at the upcoming ASH conference. Additionally, we are presenting the antigen peptide targets to be included in our first solid tumor IND application for HPV-associated malignancies at the SITC Annual Meeting. Finally, we're very excited with the progress of 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. Our team looks forward to providing future updates on these and other important projects as we continue to progress the development of our AIM technology across a range of therapy areas and with multiple modalities."

    Select 3Q 2021 Clinical and Business Highlights

    Clinical and Preclinical Updates

    NEXI-001

    • Robust immune responses across all dose levels with signs of increased clinical activity associated with higher doses
    • 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
    • Ongoing enrollment in the Phase I/II trial has been affected by higher than anticipated patient replacements between the enrollment and 28-day DLT clearance period due to non-treatment-related events; updated clinical results expected to be announced in the first 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 I/II trial is expected to be announced at the American Society of Hematology (ASH) Annual Meeting in December 2021

    NEXI-003

    • Preclinical data supporting the selection of multiple immunogenic antigen peptides commonly expressed on HPV-associated tumors is being presented during the Society for Immunotherapy of Cancer's Annual Meeting (SITC 2021) in November 2021
    • Investigational New Drug (IND) submission planned for mid-year 2022

    Other R&D

    • First collaboration in autoimmune diseases announced with Yale University Professor Kevan Herold to evaluate AIM INJ nanoparticles as a therapeutic in Type 1 diabetes

    Business Updates

    • Announced the appointments of Dr. Jack Ragheb as SVP, Translational Medicine, and Matthew Schiller as Head of Business Development

    Select 3Q 2021 Financial Highlights

    Cash, cash equivalents and marketable securities for the company as of September 30, 2021 were $93.2M compared to $102.8M for quarter ending June 30, 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 4Q22.

    Research and development expenses were $11.3M in the third quarter of 2021, compared to $4.9M 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 $4.2M, compared to $2.8M 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 $14.6M for the quarter, or a basic and diluted GAAP loss per share of $0.65. This compared to a net loss of $8.6M, or a basic and diluted GAAP loss per share of $7.52, for the same period the prior year.

    About NexImmune

    NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body's own T cells to generate a specific, potent, and durable immune response. The backbone of NexImmune's approach is a proprietary Artificial Immune Modulation (AIM™) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. AIM constructed nanoparticles employ natural biology to engage, activate and expand endogenous T cells in ways that combine anti-tumor attributes of antigen-specific precision, potency and long-term persistence with reduced potential for off-target toxicities.

    NexImmune's two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to 3 or more prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

    For more information, visit www.neximmune.com.

    Forward Looking Statements

    This press release may contain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NexImmune, Inc. (the "Company"). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning our results of operations for the nine months ended September 30, 2021; the sufficiency of the Company's current cash, cash equivalents and marketable securities to fund its planned operations through the fourth quarter of 2022; our planned and ongoing clinical trials for the Company's product candidates, including NEXI-001, NEXI-002 and NEXI-003; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical trials and preclinical studies; and the utility of prior preclinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission ("SEC") on March 31, 2021, and subsequent reports that we file with the SEC. Forward-looking statements represent the Company's beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

    Contacts

    Investors:

    Chad Rubin, SVP, Corporate Affairs

    NexImmune, Inc.

    646.319.3261



    NEXIMMUNE, INC.
     
    BALANCE SHEETS
     
     September 30,

    2021
     December 31,

    2020
     (unaudited)  
    ASSETS   
    Current assets:   
    Cash and cash equivalents$37,256,427  $5,031,079 
    Marketable securities55,986,355   
    Restricted cash67,500  67,500 
    Prepaid expenses and other current assets5,416,575  3,293,858 
    Total current assets98,726,857  8,392,437 
    Property and equipment, net4,287,254  2,885,260 
    Other non-current assets1,527,596  23,373 
    Total assets$104,541,707  $11,301,070 
    LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)   
    Current liabilities:   
    Accounts payable$3,501,098  $2,760,129 
    Accrued expenses3,931,449  2,603,027 
    Derivative liability  1,702,359 
    Other current liabilities  843,619 
    Convertible notes issued to related parties  7,324,267 
    Convertible notes  11,793,397 
    Total current liabilities7,432,547  27,026,798 
    Deferred rent, net of current portion  23,529 
    Other non-current liabilities  4,935 
    Total liabilities7,432,547  27,055,262 
    Commitments and contingencies   
    Redeemable convertible preferred stock   
    Series A Redeemable Convertible Preferred Stock, $0.0001 par value, no shares outstanding as of September 30, 2021 and 121,735,303 shares authorized, issued and outstanding as of December 31, 2020. Liquidation value of $42,314,789 as of December 31, 2020.  35,047,435 
    Series A-2 Redeemable Convertible Preferred Stock, $0.0001 par value, no shares outstanding as of September 30, 2021 and 28,384,899 shares authorized, 22,047,361 shares issued and outstanding as of December 31, 2020. Liquidation value of $8,683,746 as of December 31, 2020.  7,685,865 
    Series A-3 Redeemable Convertible Preferred Stock, $0.0001 par value, no shares outstanding as of September 30, 2021 and 34,061,879 shares authorized, 31,209,734 shares issued and outstanding as of December 31, 2020. Liquidation value of $11,699,176 as of December 31, 2020.  10,887,449 
    Total redeemable convertible preferred stock  53,620,749 
    Stockholders' equity (deficit)   
    Common Stock, $0.0001 par value, 250,000,000 shares authorized, 22,711,247 issued and outstanding as of September 30, 2021 and 1,256,609 shares issued and outstanding as of December 31, 2020.2,271  126 
    Additional paid-in-capital209,324,044  8,206,938 
    Accumulated other comprehensive income702    
    Accumulated deficit(112,217,857) (77,582,005)
    Total stockholders' equity (deficit)97,109,160  (69,374,941)
    Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)$104,541,707  $11,301,070 





    NEXIMMUNE, INC.
     
    STATEMENTS OF OPERATIONS
    (unaudited)
     
     Three Months Ended September 30, Nine Months Ended September 30,
     2021 2020 2021 2020
    Revenue$  $  $  $ 
    Operating expenses:       
    Research and development11,331,189  4,913,055  25,468,770  13,394,483 
    General and administrative4,159,196  2,752,251  12,254,838  7,406,054 
    Total operating expenses15,490,385  7,665,306  37,723,608  20,800,537 
    Loss from operations(15,490,385) (7,665,306) (37,723,608) (20,800,537)
    Other (expense) income:       
    Interest income19,855  812  30,319  20,680 
    Change in fair value of derivative liability   (397,244) 2,424,877  (397,244)
    Gain on extinguishment of debt843,619    843,619   
    Interest expense(1,106) (559,325) (905,326) (743,996)
    Other (expense) income(19,095) 12,328  (45,791) 66,329 
    Other (expense) income843,273  (943,429) 2,347,698  (1,054,231)
    Net Loss$(14,647,112) $(8,608,735) $(35,375,910) $(21,854,768)
    Accumulated dividends on Redeemable Convertible Preferred Stock  (824,781) (377,562)  (2,456,413)
    Net loss attributable to common stockholders$(14,647,112) $(9,433,516) $(35,753,472) $(24,311,181)
    Basic and diluted net loss attributable to common stockholders per common share$(0.65) $(7.52) $(1.85) $(19.38)
    Basic and diluted weighted-average number of common shares outstanding22,653,410  1,254,808  19,335,170  1,254,724 





    STATEMENTS OF COMPREHENSIVE LOSS
    (unaudited)
     
     Three Months Ended September 30, Nine Months Ended September 30,
     2021 2020 2021 2020
    Net loss$(14,647,112) $(8,608,735) $(35,375,910) $(21,854,768)
    Other comprehensive loss:       
    Unrealized (loss) gain on available-for-sale marketable securities, net of tax3,619    702  (506)
    Comprehensive loss$(14,643,493) $(8,608,735) $(35,375,208) $(21,855,274)


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  3. GAITHERSBURG, Md., Nov. 08, 2021 (GLOBE NEWSWIRE) -- 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, today announced it plans to report third quarter financial results and provide a corporate update on Friday, November 12, 2021, via press release, prior to the market open.

    The press release will be accessible under the investor section of the NexImmune's website at www.neximmune.com.

    About NexImmune

    NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body's own T cells to generate a specific, potent…

    GAITHERSBURG, Md., Nov. 08, 2021 (GLOBE NEWSWIRE) -- 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, today announced it plans to report third quarter financial results and provide a corporate update on Friday, November 12, 2021, via press release, prior to the market open.

    The press release will be accessible under the investor section of the NexImmune's website at www.neximmune.com.

    About NexImmune

    NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body's own T cells to generate a specific, potent, and durable immune response. The backbone of NexImmune's approach is a proprietary Artificial Immune Modulation (AIM™) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. AIM constructed nanoparticles employ natural biology to engage, activate and expand endogenous T cells in ways that combine anti-tumor attributes of antigen-specific precision, potency and long-term persistence with reduced potential for off-target toxicities.

    NexImmune's two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

    For more information, visit www.neximmune.com.

    Forward Looking Statements

    This press release may contain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NexImmune, Inc. (the "Company"). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning our planned and ongoing clinical studies for the Company's product candidates, including NEXI-001 and NEXI-002; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; and the utility of prior preclinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission ("SEC") on March 31, 2021, and subsequent reports that we file with the SEC. Forward-looking statements represent the Company's beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

    Contacts

    Investors:

    Chad Rubin, SVP Corporate Affairs

    NexImmune, Inc.

    646.319.3261



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