NextCure Provides Business Update and Reports Second Quarter 2022 Financial Results
- On track to report data from all three clinical programs
- Second quarter ending cash of
$185.5 millionexpected to fund operations into the first quarter of 2024
“We have set the stage for multiple clinical data updates in the second half of this year for our NC318, NC410, and NC762 programs as well as an IND filing for NC525,” said
- Announced the publication of a paper titled “Development of an Immunohistochemical Assay for Siglec-15” in Laboratory Investigation. The publication outlines data from a study, conducted in collaboration with researchers in the
Department of Pathologyat Yale School of Medicine, utilizing a newly developed antibody to Siglec-15 (S15) and an immunohistochemical (IHC) assay to investigate S15 expression in solid tumors.
- Presented in vivo data at the 2022
Extracellular Matrix (ECM) Pharmacology Congressin Copenhagenthat demonstrated NC410 remodels tumor ECM, enhances immune cell infiltration, alleviates immunosuppression, and reduces tumor growth in a humanized mouse tumor model.
- Announced that collaborator
Brahm Segal, M.D., of Roswell Park Comprehensive Cancer Centershared nonclinical data from a research study that models the ability of NC410 to block neutrophil-mediated suppression of T cells in a tumor microenvironment (TME) at the 24th Translational Research Cancer Centers ConsortiumAnnual Meeting. In addition, NextCureappointed Dr. Segalto its Scientific Advisory Board(SAB).
Expected Upcoming Milestones
The company remains on track for the following 2022 milestones:
- NC318 (S15 mAb) Phase 2 update: fourth quarter of 2022 (Amended Phase 2 with patient selection and increased dosing).
- NC318 (S15 mAb) anti-PD-1 combo initial data: second half of 2022 (Yale University Investigator-Initiated trial).
- NC410 (LAIR-2 fusion) Phase 1 update: second half of 2022.
- NC762 (B7-H4 mAb) Phase 1 initial data: second half of 2022.
- NC525 (LAIR-1 mAb) Investigational New Drug (IND) Application filing: fourth quarter of 2022.
Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into the first quarter of 2024.
Financial Results for Quarter Ended
- Cash, cash equivalents, and marketable securities, excluding restricted cash as of
June 30, 2022, were $185.5 millionas compared to $219.6 millionas of December 31, 2021. The decrease of $34.1 millionprimarily related to cash used to fund operations, cash used to purchase fixed assets, and changes in the fair value of our marketable securities.
- Research and development expenses were
$12.8 millionfor the quarter ended June 30, 2022, as compared to $11.9 millionfor the quarter ended June 30, 2021. The increase of $0.9 millionwas driven primarily by additional clinical and lab-related costs.
- General and administrative expenses were
$5.3 millionfor the quarter ended June 30, 2022, as compared to $6.0 millionfor the quarter ended June 30, 2021. The decrease of $0.7 millionwas primarily related to reduced professional services and personnel-related costs.
- Net loss was
$17.9 millionfor the quarter ended June 30, 2022, as compared with a net loss of $18.0 millionfor the quarter ended June 30, 2021. The changes in net loss from the previous year’s quarter was primarily due to higher interest income and lower general administrative expenses offset by increased research and development expenses.
Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to our plans, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans regarding our immunomedicines and upcoming milestones. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “should,” “due,” “estimate,” “expect,” “intend,” “hope,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “target,” “towards,” “forward,” “later,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language.
Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: the impacts of the COVID-19 pandemic (including the emergence of variant strains) on NextCure’s business, including NextCure’s clinical trials, third parties on which
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share amounts)
|Selected Financial Information|
|Selected Statement of Operations Items:||Three Months Ended
||Six Months Ended
|(in thousands, except share and per share amounts)||2022
|Research and development||$||12,825||$||11,945||$||27,849||$||24,331|
|General and administrative||5,303||6,007||11,050||10,855|
|Loss from operations||(18,128||)||(17,952||)||(38,899||)||(35,186||)|
|Other income, net||208||(35||)||377||666|
|Net loss per common share - basic and diluted||$||(0.65||)||$||(0.65||)||$||(1.39||)||$||(1.25||)|
|Weighted-average shares outstanding - basic and diluted||27,744,762||27,610,398||27,726,864||27,603,948|
|Selected Balance Sheet Items:|
|Cash, cash equivalents, and marketable securities||$||185,492||$||219,591|
|Accounts payable and accrued expenses||5,597||6,391|
|Total stockholders' equity||198,196||233,386|
Chief Operating Officer