NextCure Reports Third Quarter 2020 Financial Results
“We continue to enroll in our ongoing NC318 and NC410 clinical trials. In addition, we are making progress analyzing biomarker data, including Siglec-15 expression in biopsies from the NC318 Phase 2 trial,” said
Business Highlights and upcoming milestones
- Continue enrolling new patients in the head and neck squamous cell carcinoma and triple-negative breast cancer cohorts of the NC318 Phase 2 monotherapy trial.
- Plan to report updated clinical and initial biomarker data from the Phase 1 and 2 portions of the NC318 Phase 1/2 monotherapy clinical trial by the end of 2020.
- Continue enrolling patients in the Phase 1 portion of a Phase 1/2 clinical trial for NC410 and remain on track to report initial clinical data in the second half of 2021 as planned.
- Two abstracts regarding pre-clinical research for the NC410 program accepted for poster presentation at the upcoming virtual 35th Annual Meeting of the
Society for Immunotherapy of Cancer (SITC) in November. - Announced the appointment of
John G. Houston , Ph.D., president and chief executive officer of clinical-stage biopharmaceutical company Arvinas, Inc., to NextCure’s Board of Directors.
Financial Results for Quarter Ended
- Cash, cash equivalents and marketable securities as of
September 30, 2020 were$291.2 million , as compared to$334.6 million as ofDecember 31, 2019 . The decrease of$43.4 million as ofSeptember 30, 2020 as compared to as ofDecember 31, 2019 primarily reflects cash used to fund operations of$38.6 million and cash used to purchase fixed assets of$6.2 million offset by a reduction in restricted cash of$1.1 million . - Research and development expenses were
$12.7 million for the quarter endedSeptember 30, 2020 , as compared to$8.7 million for the quarter endedSeptember 30, 2019 . The increase was primarily related to an increase in headcount. Other significant components of the increase included clinical research costs related to advancing NC318 and NC410. - General and administrative expenses were
$4.7 million for the quarter endedSeptember 30, 2020 , as compared to$2.6 million for the quarter endedSeptember 30, 2019 . The increase was primarily related to increases in personnel-related costs due to an increase in headcount, as well as increases in professional fees and insurance costs in connection with operating as a publicly traded company. - There was no revenue recognized in the quarter ended
September 30, 2020 , as compared to$1.6 million for the quarter endedSeptember 30, 2019 . Revenue generated in the prior year quarter was from our former research and development agreement with Eli Lilly. - Net loss was
$16.4 million for the quarter endedSeptember 30, 2020 , as compared to$8.4 million for the quarter endedSeptember 30, 2019 . 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
Forward-Looking Statements
This press release contains forward-looking statements, including statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts, assumptions and other information available to
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share amounts)
| Three Months Ended | Nine Months Ended | ||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||||
| Revenue: | |||||||||||||||||
| Revenue from research and development arrangement | $ | — | $ | 1,583 | $ | 22,378 | $ | 4,342 | |||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 12,740 | 8,663 | 34,448 | 22,819 | |||||||||||||
| General and administrative | 4,659 | 2,622 | 12,918 | 6,995 | |||||||||||||
| Total operating expenses | 17,399 | 11,285 | 47,366 | 29,814 | |||||||||||||
| Loss from operations | (17,399 | ) | (9,702 | ) | (24,988 | ) | (25,472 | ) | |||||||||
| Other income, net | 1,032 | 1,268 | 3,846 | 2,662 | |||||||||||||
| Net loss | $ | (16,367 | ) | $ | (8,434 | ) | $ | (21,142 | ) | $ | (22,810 | ) | |||||
| Loss per share: | |||||||||||||||||
| Net loss per common share—basic and diluted | $ | (0.59 | ) | $ | (0.37 | ) | $ | (0.77 | ) | $ | (1.81 | ) | |||||
| Weighted average number of common shares —basic and diluted | 27,547,737 | 22,715,567 | 27,524,350 | 12,609,219 | |||||||||||||
| Comprehensive loss: | |||||||||||||||||
| Net loss | $ | (16,367 | ) | $ | (8,434 | ) | $ | (21,142 | ) | $ | (22,810 | ) | |||||
| Unrealized gain (loss) on marketable securities | (637 | ) | (58 | ) | 1,298 | (58 | ) | ||||||||||
| Total comprehensive loss | $ | (17,004 | ) | $ | (8,492 | ) | $ | (19,844 | ) | $ | (22,868 | ) | |||||
CONDENSED BALANCE SHEETS
(unaudited, in thousands, except share and per share amounts)
| 2020 | 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 22,534 | $ | 34,091 | ||||
| Marketable securities | 268,672 | 300,514 | ||||||
| Restricted cash | 1,706 | 1,706 | ||||||
| Prepaid expenses and other current assets | 4,069 | 3,684 | ||||||
| Total current assets | 296,981 | 339,995 | ||||||
| Property and equipment, net | 15,819 | 12,090 | ||||||
| Other assets | 3,278 | 4,083 | ||||||
| Total assets | $ | 316,078 | $ | 356,168 | ||||
| Liabilities, Preferred Stock and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 186 | $ | 1,861 | ||||
| Accrued liabilities | 3,754 | 4,871 | ||||||
| Deferred rent, current portion | 134 | 215 | ||||||
| Term loan, current portion | 1,667 | 1,667 | ||||||
| Deferred revenue, current portion | — | 6,428 | ||||||
| Total current liabilities | 5,741 | 15,042 | ||||||
| Deferred rent, net of current portion | 776 | 359 | ||||||
| Term loan, net of current portion | 2,222 | 3,333 | ||||||
| Deferred revenue, net of current portion | — | 15,950 | ||||||
| Total liabilities | 8,739 | 34,684 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, par value of |
— | — | ||||||
| Common stock, par value of |
28 | 27 | ||||||
| Additional paid-in capital | 408,189 | 402,529 | ||||||
| Accumulated other comprehensive income (loss) | 1,298 | (38 | ) | |||||
| Accumulated deficit | (102,176 | ) | (81,034 | ) | ||||
| Total stockholders’ equity | 307,339 | 321,484 | ||||||
| Total liabilities, preferred stock and stockholders’ equity | $ | 316,078 | $ | 356,168 | ||||
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