NextCure Reports First Quarter 2021 Financial Results
“We are highly focused on advancing our three clinical programs and broadening our pipeline of novel immunomedicines this year. We are committed to continuing to evaluate NC318 in multiple indications in our Phase 2 monotherapy trial as well as the Phase 2 investigator-initiated clinical trial at
Business Highlights and Upcoming Milestones
- Commenced the Yale University Phase 2 investigator-initiated clinical trial of NC318 in combination with pembrolizumab in patients with advanced non-small cell lung cancer with anticipated initial data in the first half of 2022.
- Presented preclinical and investigational new drug (IND)-enabling data for NC762 at the
American Association for Cancer Research Annual Meeting 2021. - On track to initiate the NC762 Phase 1 clinical trial in the second quarter of 2021 and report initial data in mid-2022.
- On track to report NC318 Phase 2 monotherapy update in the fourth quarter of 2021.
- Continue enrolling patients in the Phase 1 portion of a Phase 1/2 clinical trial for NC410 and on track to report initial clinical data in the second half of 2021.
- Present trial in progress poster for NC410 at the upcoming 2021
American Society of Clinical Oncology (ASCO) Virtual Annual Meeting.
Financial Guidance
Based on its current research and development plans,
Financial Results for Quarter Ended
- Cash, cash equivalents, and marketable securities, excluding restricted cash as of
March 31, 2021 , were$268.2 million as compared with$283.4 million as ofDecember 31, 2020 . The decrease of$15.2 million reflects cash used to fund operations of$13.9 million and cash used to purchase fixed assets of$0.8 million . - Research and development expenses were
$12.4 million for the quarter endedMarch 31, 2021 as compared to$10.6 million for the quarter endedMarch 31, 2020 . The increase was primarily related to increase in personnel-related costs. - General and administrative expenses were
$4.8 million for the quarter endedMarch 31, 2021 , as compared to$3.6 million for the quarter endedMarch 31, 2020 . The increase was primarily related to increase in personnel-related costs. - Revenue was not recognized in the quarter ended
March 31, 2021 , as compared to$22.4 million for the quarter endedMarch 31, 2020 . Revenue generated in the first quarter of 2020 was from our former research and development agreement with Eli Lilly. - Net loss was
$16.5 million for the quarter ended Mach 31, 2021, as compared with net income of$9.7 million for the quarter endedMarch 31, 2020 . The change to a loss from the previous year’s quarter were primarily due to the recognition in the prior year of the remaining deferred revenue under the former agreement with Eli Lilly and increased personnel-related costs in both research and development expenses and general and administrative expenses.
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 | |||||||||
| 2021 | 2020 | ||||||||
| Revenue: | |||||||||
| Revenue from former research and development arrangement | $ | — | $ | 22,378 | |||||
| Operating expenses: | |||||||||
| Research and development | 12,386 | 10,578 | |||||||
| General and administrative | 4,848 | 3,588 | |||||||
| Total operating expenses | 17,234 | 14,166 | |||||||
| (Loss) income from operations | (17,234 | ) | 8,212 | ||||||
| Other income, net | 701 | 1,521 | |||||||
| Net (loss) income | $ | (16,533 | ) | $ | 9,733 | ||||
| (Loss) earnings per share: | |||||||||
| Basic | $ | (0.60 | ) | $ | 0.35 | ||||
| Diluted | $ | (0.60 | ) | $ | 0.33 | ||||
| Shares used in the calculation of (loss) earnings per share: | |||||||||
| Basic | 27,597,426 | 27,506,927 | |||||||
| Diluted | 27,597,426 | 29,348,615 | |||||||
| Comprehensive (loss) income: | |||||||||
| Net (loss) income | $ | (16,533 | ) | $ | 9,733 | ||||
| Unrealized loss on marketable securities | (600 | ) | (543 | ) | |||||
| Total comprehensive (loss) income | $ | (17,133 | ) | $ | 9,190 | ||||
NEXTCURE, INC.
CONDENSED BALANCE SHEETS
(unaudited, in thousands, except share and per share amounts)
| 2021 |
2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 36,527 | $ | 32,772 | ||||
| Marketable securities | 231,709 | 250,676 | ||||||
| Restricted cash | 1,706 | 1,706 | ||||||
| Prepaid expenses and other current assets | 3,109 | 2,824 | ||||||
| Total current assets | 273,051 | 287,978 | ||||||
| Property and equipment, net | 15,470 | 15,809 | ||||||
| Other assets | 2,438 | 2,857 | ||||||
| Total assets | $ | 290,959 | $ | 306,644 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,017 | $ | 3,901 | ||||
| Accrued liabilities | 4,295 | 4,627 | ||||||
| Deferred rent, current portion | 209 | 130 | ||||||
| Term loan, current portion | 1,667 | 1,667 | ||||||
| Total current liabilities | 8,188 | 10,325 | ||||||
| Deferred rent, net of current portion | 2,223 | 792 | ||||||
| Term loan, net of current portion | 1,389 | 1,806 | ||||||
| Total liabilities | 11,800 | 12,923 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, par value of |
— | — | ||||||
| Common stock, par value of |
28 | 28 | ||||||
| Additional paid-in capital | 413,122 | 410,551 | ||||||
| Accumulated other comprehensive income | 179 | 779 | ||||||
| Accumulated deficit | (134,170 | ) | (117,637 | ) | ||||
| Total stockholders’ equity | 279,159 | 293,721 | ||||||
| Total liabilities and stockholders’ equity | $ | 290,959 | $ | 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
Source: NextCure