Full Press Release Details
Second Quarter 2021 Financial Results
BELTSVILLE, Md. - August 5, 2021 - NextCure, Inc.
(Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines
to treat cancer and other immune-related diseases, today reported second quarter 2021 financial results and provided a business update.
"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 Michael Richman, NextCure's president and chief executive officer. "We expect to provide a data update from our ongoing
Phase 2 monotherapy trial of NC318, as well as to report Phase 1 data for NC410 by year-end. We have initiated clinical development of
our third program, NC762 targeting B7-H4, with anticipated initial Phase 1 data mid-2022."
Business Highlights and Upcoming Milestones
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 expenditure requirements
into the second half of 2023.
Financial Results for Quarter Ended June 30, 2021
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. NextCure believes NC318 has the potential to treat multiple cancer
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. NextCure believes NC410
has the potential to treat multiple cancer types.
NC762 is a monoclonal antibody that binds specifically to B7-H4, a
protein expressed on multiple tumor types. NextCure believes NC762 acts by inhibiting tumor cell growth and killing tumor cells, including
by enhancing immune response. The company has observed in preclinical studies that NC762 inhibits the growth of human melanoma tumors
in mice and believes that NC762 has the potential to treat multiple tumor types. NextCure's research indicates that NC762 inhibits
tumor cell growth independently of immune cell infiltration in the tumor microenvironment.
About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company committed to
discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases. Through our proprietary
FIND-IO platform, we study various immune cells to discover and understand targets and structural components of immune cells and
their functional impact in order to develop immunomedicines. Our initial focus is to bring hope and new treatments to patients who do
not respond to current cancer therapies, patients whose cancer progresses despite treatment and patients with cancer types not adequately
addressed by available therapies. www.nextcure.com
Forward-Looking Statements
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.
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
NextCure relies and NextCure's operations; positive results in preclinical studies may not be predictive of the results of
clinical trials; NextCure's limited operating history and no products approved for commercial sale; NextCure's history
of significant losses; NextCure's need to obtain additional financing; risks related to clinical development, marketing
approval and commercialization; the unproven approach to the discovery and development of product candidates based on
NextCure's FIND-IO platform; and dependence on key personnel. More detailed information on these and additional factors that
could affect NextCure's actual results are described under the heading "Risk Factors" in NextCure's most
recent Annual Report on Form 10-K and in the Company's other filings with the Securities and Exchange Commission. You should
not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press
release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
(unaudited, in thousands, except share and
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 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 | ) |
CONDENSED BALANCE SHEETS
(unaudited, in thousands, except share and
| June 30, | December 31, | |||||||
| 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 $0.001 per share; 10,000,000 shares authorized at June 30, 2021 and December 31, 2020; no shares issued and outstanding at June 30, 2021 and December 31, 2020 | - | - | ||||||
| Common stock, par value of $0.001 per share; 100,000,000 shares authorized at June 30, 2021 and December 31, 2020; 27,611,555 and 27,568,802 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 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 |
Timothy Mayer, Ph.D.
Chief Operating Officer