NEXTCURE, INC. “We have made notable progress across all of our clinical programs including several enhancements to the ongoing NC318 Phase 2 monotherapy trial. Clinical sites can now select for S15+ patients, through screening biopsies in a CLIA certified laboratory. In addition, we have resumed enrolling non-small cell lung cancer (NSCLC) adenocarcinoma patients in the ongoing NC318 monotherapy trial and have revised the NC318 dosing regimen to increase overall drug exposure to NC318,” said
Business Highlights and Upcoming Milestones
- NC318
- Clinical Laboratory Improvement Amendments (CLIA) validated assay available for S15+ patient selection to effectively evaluate NC318 activity in patients with S15+ tumors.
- Resumed enrollment of a non-small cell lung cancer (NSCLC) adenocarcinoma cohort in the ongoing Phase 2 monotherapy trial.
- Revised dosing regimen to 800 mg weekly to increase overall drug exposure.
- On track to report Phase 2 monotherapy update in the fourth quarter of 2021.
- In the second quarter of 2021,
Yale University commenced a Phase 2 investigator-initiated clinical trial of NC318 in combination with pembrolizumab in patients with advanced NSCLC with anticipated initial data in the first half of 2022.
- NC410
- Presented trial in progress poster at the 2021
American Society of Clinical Oncology (ASCO) Virtual Annual Meeting. - Published preclinical data demonstrating that NC410 promoted T cell mediated anti-tumor immunity, enhanced infiltration and increased localized activity of T cells in the tumor microenvironment.
- On track to report initial clinical data in the fourth quarter of 2021.
- Presented trial in progress poster at the 2021
- NC762
- Started the Phase 1 portion of a Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors.
- Initial data anticipated to be available in mid-2022.
Financial Guidance
Based on its current research and development plans,
Financial Results for Quarter Ended
- Cash, cash equivalents and marketable securities as of
June 30, 2021 were$249.5 million , compared to$283.4 million as ofDecember 31, 2020 . The decrease of$33.9 million primarily reflects cash used to fund operations, cash used to purchase fixed assets, and repayments on a term loan. - Research and development expenses were
$11.9 million for the quarter endedJune 30, 2021 , as compared to$11.1 million for the quarter endedJune 30, 2020 . The increase was driven primarily by clinical-related costs, partially offset by timing of clinical supply costs. - General and administrative expenses were
$6.0 million for the quarter endedJune 30, 2021 , as compared to$4.7 million for the quarter endedJune 30, 2020 . The increase was driven primarily by personnel-related costs. - Net loss was
$18.0 million for the quarter endedJune 30, 2021 , as compared to$14.5 million for the quarter endedJune 30, 2020 . The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount.
About NC318
NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15.
About NC410
NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells, a type of antigen presenting cell. In preclinical research, it was observed that LAIR-1 inhibited T cell function and dendritic cell activity allowing tumor cells to grow. In preclinical studies, NC410 blocked the negative effects of LAIR-1 and promoted T cell function and dendritic cell activity.
About NC762
NC762 is a monoclonal antibody that binds specifically to B7-H4, a protein expressed on multiple tumor types.
About
Forward-Looking Statements
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)
| Three Months Ended | Six Months Ended | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Revenue: | |||||||||||||||
| Revenue from former research and development arrangement | $ | — | $ | — | $ | — | $ | 22,378 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 11,945 | 11,130 | 24,331 | 21,708 | |||||||||||
| General and administrative | 6,007 | 4,671 | 10,855 | 8,259 | |||||||||||
| Total operating expenses | 17,952 | 15,801 | 35,186 | 29,967 | |||||||||||
| Loss from operations | (17,952 | ) | (15,801 | ) | (35,186 | ) | (7,589 | ) | |||||||
| Other income (expense), net | (35 | ) | 1,293 | 666 | 2,814 | ||||||||||
| Net loss | $ | (17,987 | ) | $ | (14,508 | ) | $ | (34,520 | ) | $ | (4,775 | ) | |||
| Loss per share - basic and diluted | $ | (0.65 | ) | $ | (0.53 | ) | $ | (1.25 | ) | $ | (0.17 | ) | |||
| Weighted-average shares outstanding - basic and diluted | 27,610,398 | 27,518,129 | 27,603,948 | 27,512,528 | |||||||||||
| Comprehensive loss: | |||||||||||||||
| Net loss | $ | (17,987 | ) | $ | (14,508 | ) | $ | (34,520 | ) | $ | (4,775 | ) | |||
| Unrealized gain (loss) on marketable securities | (374 | ) | 2,478 | (974 | ) | 1,935 | |||||||||
| Total comprehensive loss | $ | (18,361 | ) | $ | (12,030 | ) | $ | (35,494 | ) | $ | (2,840 | ) | |||
NEXTCURE, INC.
CONDENSED BALANCE SHEETS
(unaudited, in thousands, except share and per share amounts)
| 2021 | 2020 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 34,903 | $ | 32,772 | |||
| Marketable securities | 214,617 | 250,676 | |||||
| Restricted cash | 1,706 | 1,706 | |||||
| Prepaid expenses and other current assets | 7,406 | 2,824 | |||||
| Total current assets | 258,632 | 287,978 | |||||
| Property and equipment, net | 14,709 | 15,809 | |||||
| Other assets | 2,018 | 2,857 | |||||
| Total assets | $ | 275,359 | $ | 306,644 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 1,351 | $ | 3,901 | |||
| Accrued liabilities | 5,344 | 4,627 | |||||
| Deferred rent, current portion | 203 | 130 | |||||
| Term loan, current portion | 1,667 | 1,667 | |||||
| Total current liabilities | 8,565 | 10,325 | |||||
| Deferred rent, net of current portion | 2,224 | 792 | |||||
| Term loan, net of current portion | 972 | 1,806 | |||||
| Total liabilities | 11,761 | 12,923 | |||||
| Stockholders’ equity: | |||||||
| Preferred stock, par value of | — | — | |||||
| Common stock, par value of | 28 | 28 | |||||
| Additional paid-in capital | 415,922 | 410,551 | |||||
| Accumulated other comprehensive (loss) income | (195 | ) | 779 | ||||
| Accumulated deficit | (152,157 | ) | (117,637 | ) | |||
| Total stockholders’ equity | 263,598 | 293,721 | |||||
| Total liabilities and stockholders’ equity | $ | 275,359 | $ | 306,644 | |||
Investor InquiriesTimothy Mayer , Ph.D.NextCure, Inc. Chief Operating Officer (240) 762-6486 IR@nextcure.com Media InquiriesEmily Wong MacDougall (781) 235-3060 NextCure@macbiocom.com
2021 GlobeNewswire, Inc., source
