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 for liquid and solid malignancies, today reported financial results for the second quarter of 2022.
“We are encouraged by the increase in enrollment in our NEXI-001 trial and look forward to providing a clinical update in fourth quarter,” said Kristi Jones, Chief Executive Officer. “The FDA has recently cleared the NEXI-003 IND, enabling us to advance our first solid tumor program in HPV-related malignancies and we plan to initiate the study before year end. Due to resource prioritization, and the evolving treatment landscape in relapsed refractory multiple myeloma, we plan to pause enrollment of NEXI-002 and provide an update on patients currently being treated. In parallel, we continue to make progress on our IND-enabling work for the AIM injectable modality, an ‘off-the-shelf’ multi-antigen specific approach to treating malignancies and autoimmune diseases, which we believe has the potential to be disruptive. We will provide an update on these early programs through the end of year. We continue to focus on generating data and demonstrating the potential of our ‘IND engine’ to enable a rapid path to clinical development and look forward to providing updates on our progress and upcoming catalysts.”
Second Quarter 2022 Clinical and Business Highlights
Clinical and Preclinical Updates
NEXI-001
NEXI-003
NEXI-002
Injectable “Off-the-shelf” Antigen-Specific Immunotherapy and Other Preclinical Research
Select Second Quarter 2022 Financial Highlights
Cash, cash equivalents and marketable securities for the Company as of June 30, 2022 were $53.1 million compared to $65.0 million for the quarter ending March 31, 2022. Based on 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 $11.8 million in the second quarter of 2022, compared to $8.1 million for the same period in the prior year. The increase in research and development expenses was mainly attributable to costs for the two ongoing clinical trials, as well as personnel-related expenses driven by increased headcount.
General and administrative expenses were $4.1 million, compared to $4.0 million for the same period in the prior year. The slight increase was primarily due to increased fees related to professional and consulting services offset by reductions in personnel-related expenses.
Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $15.9 million for the quarter, or a basic and diluted GAAP loss per share of $0.69. This compares to a net loss of $12.2 million, or a basic and diluted GAAP loss per share of $0.54, for the same period in 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.
NexImmune’s lead programs, NEXI-001, NEXI-002 and NEXI-003, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation, multiple myeloma refractory to 3 or more prior lines of therapy and HPV-related cancers, respectively. NexImmune is also developing AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.
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.
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, NEXI-002 and NEXI-003; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; the timing, progress and release of preclinical data from our AIM injectable platform programs and other preclinical research programs; 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, 2021 filed with the Securities and Exchange Commission (“SEC”) on March 9, 2022, 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.
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NEXIMMUNE, INC.
BALANCE SHEETS
June 30, 2022 | December 31, 2021 | ||||||
(unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 40,644,227 | $ | 30,326,352 | |||
Marketable securities | 12,484,305 | 51,491,942 | |||||
Restricted cash | 105,000 | 67,500 | |||||
Prepaid expenses and other current assets | 6,355,781 | 4,394,916 | |||||
Total current assets | 59,589,313 | 86,280,710 | |||||
Property and equipment, net | 4,709,036 | 4,427,307 | |||||
Operating lease right-of-use assets | 1,221,668 | — | |||||
Other non-current assets | 146,013 | 324,099 | |||||
Total assets | $ | 65,666,030 | $ | 91,032,116 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,652,435 | $ | 1,045,159 | |||
Accrued expenses | 6,871,039 | 6,170,709 | |||||
Operating lease liabilities, current | 590,313 | — | |||||
Total current liabilities | 9,113,787 | 7,215,868 | |||||
Operating lease liabilities, net of current portion | 699,562 | — | |||||
Deferred rent, net of current portion | — | 55,581 | |||||
Total liabilities | 9,813,349 | 7,271,449 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity | |||||||
Common Stock, $0.0001 par value, 250,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 22,893,551 and 22,828,904 issued and outstanding as of June 30, 2022 and December 31, 2021 | 2,289 | 2,283 | |||||
Additional paid-in-capital | 214,486,976 | 211,498,827 | |||||
Accumulated other comprehensive income | (9,335 | ) | 3,012 | ||||
Accumulated deficit | (158,627,249 | ) | (127,743,455 | ) | |||
Total stockholders’ equity | 55,852,681 | 83,760,667 | |||||
Total liabilities and stockholders’ equity | $ | 65,666,030 | $ | 91,032,116 | |||
NEXIMMUNE, INC.
STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | — | |||||||
Operating expenses: | |||||||||||||||
Research and development | 11,837,519 | 8,124,973 | 22,286,362 | 14,137,581 | |||||||||||
General and administrative | 4,088,445 | 4,038,050 | 8,693,124 | 8,095,642 | |||||||||||
Total operating expenses | 15,925,964 | 12,163,023 | 30,979,486 | 22,233,223 | |||||||||||
Loss from operations | (15,925,964 | ) | (12,163,023 | ) | (30,979,486 | ) | (22,233,223 | ) | |||||||
Other (expense) income: | |||||||||||||||
Interest income | 84,221 | 6,851 | 117,314 | 10,464 | |||||||||||
Change in fair value of derivative liability | — | — | — | 2,424,877 | |||||||||||
Interest expense | — | (101 | ) | — | (904,220 | ) | |||||||||
Other expense | (19,046 | ) | (25,974 | ) | (21,622 | ) | (26,696 | ) | |||||||
Other income (expense) | 65,175 | (19,224 | ) | 95,692 | 1,504,425 | ||||||||||
Net Loss | $ | (15,860,789 | ) | $ | (12,182,247 | ) | $ | (30,883,794 | ) | $ | (20,728,798 | ) | |||
Accumulated dividends on Redeemable Convertible Preferred Stock | — | — | — | (377,562 | ) | ||||||||||
Net loss attributable to common stockholders | $ | (15,860,789 | ) | $ | (12,182,247 | ) | $ | (30,883,794 | ) | $ | (21,106,360 | ) | |||
Basic and diluted net loss attributable to common stockholders per common share | $ | (0.69 | ) | $ | (0.54 | ) | $ | (1.35 | ) | $ | (1.20 | ) | |||
Basic and diluted weighted-average number of common shares outstanding | 22,871,369 | 22,608,866 | 22,854,311 | 17,648,551 | |||||||||||
STATEMENTS OF COMPREHENSIVE LOSS
(unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Net loss | $ | (15,860,789 | ) | $ | (12,182,247 | ) | $ | (30,883,794 | ) | $ | (20,728,798 | ) | |||
Other comprehensive loss: | |||||||||||||||
Unrealized gain (loss) on available-for-sale marketable securities, net of tax | 11,243 | (2,917 | ) | (12,347 | ) | (2,917 | ) | ||||||||
Comprehensive loss | $ | (15,849,546 | ) | $ | (12,185,164 | ) | $ | (30,896,141 | ) | $ | (20,731,715 | ) | |||
Last Trade: | US$0.19 |
Daily Change: | -0.02 -9.52 |
Daily Volume: | 14,170 |
Market Cap: | US$264K |
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