NextCure Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results
“Our team has worked diligently throughout 2020 to advance our programs despite the difficult environment created by the COVID-19 pandemic. We are thrilled that Dr.
Business Highlights
- NC318
- The two previously announced objective responder patients in the Phase 1 portion of the company’s ongoing Phase 1/2 clinical trial are continuing to receive drug and remain on study at over 118 weeks and over 92 weeks.
- The trial continues in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer (TNBC) patients.
- The previously announced confirmed partial response (PR) seen in the HNSCC cohort is off study after 40 weeks.
- A confirmed PR has been observed in the TNBC cohort and the patient remains on study at over 21 weeks.
- Given these responses in the HNSCC and TNBC cohorts, these cohorts met the criteria to advance into the stage 2 portion of the Simon 2-stage trial.
- The NC318 Phase 2 monotherapy protocol will be revised to select S15+ patients for enrollment starting in the second quarter of this year.
Yale University plans to initiate in the second quarter of 2021, an investigator-initiated Phase 2 trial of NC318 as a monotherapy and in combination with pembrolizumab in patients with advanced non-small cell lung cancer.
- NC410
- Enrollment is on track and the company expects to announce initial clinical data from the Phase 1 portion of the trial in the second half of 2021.
- NC762
- An investigational new drug (IND) application has been filed with the
U.S. Food and Drug Administration (FDA) for NC762, a humanized monoclonal antibody targeting B7-H4, which is upregulated in multiple solid tumor types, and which we believe is differentiated from other B7-H4-targeted antibodies.
- An investigational new drug (IND) application has been filed with the
- Announced the appointment of Dr.
Han Myint as Chief Medical Officer.
Expected Upcoming Milestones
- Initiate in the second quarter of 2021, the Yale University Phase 2 investigator-initiated trial of NC318 in NSCLC with anticipated initial data first half of 2022.
- Report NC318 Phase 2 monotherapy data in the fourth quarter of 2021.
- Initiate the NC762 Phase 1 trial in the second quarter of 2021 and report initial data in mid-2022.
- Report NC410 initial Phase 1 data in the second half of 2021.
Financial Guidance
Based on its current research and development plans,
Financial Results for Fourth Quarter and Full Year Ended
- Cash, cash equivalents, and marketable securities, excluding restricted cash as of
December 31, 2020 , were$283.4 million as compared with$334.6 million as ofDecember 31, 2019 . The decrease of$51.2 million as ofDecember 31, 2020 as compared toDecember 31, 2019 primarily reflects cash used to fund operations of$44.9 million and cash used to purchase fixed assets of$7.2 million , offset by a reduction in restricted cash of$1.5 million . - Research and development expenses were
$46.6 million and$12.1 million for the year and quarter endedDecember 31, 2020 , respectively, as compared with$34.2 million and$11.4 million for the year and quarter endedDecember 31, 2019 , respectively. The increase was primarily related to increase in headcount and clinical research costs related to advancing NC318 and NC410. - General and administrative expenses were
$17.0 million and$4.1 million for the year and quarter endedDecember 31, 2020 , respectively, as compared with$9.6 million and$2.6 million for the year and quarter endedDecember 31, 2019 , respectively. The increase in general and administrative expenses for the year and quarter primarily related to increasing infrastructure costs and being a public company for a full year in 2020. - Revenue was
$22.4 million for the year endedDecember 31, 2020 . There was no revenue recognized in the quarter endedDecember 31, 2020 , as compared with$6.3 million and$2.0 million for the year and quarter endedDecember 31, 2019 , respectively. Revenue generated was from our former research and development agreement with Eli Lilly. - Net loss was
$36.6 million and$15.5 million for the year and quarter endedDecember 31, 2020 , respectively, as compared with$33.7 million and$10.9 million for the year and quarter endedDecember 31, 2019 , respectively. The increases in net loss for the year and quarter were primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount, offset by the recognition of the remaining deferred revenue under the former agreement with Lilly.
Conference Call
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. We believe NC762 acts by inhibiting tumor cell growth and killing tumor cells, including by enhancing immune response. We have observed in preclinical studies that NC762 inhibits the growth of human melanoma tumors in mice, and we believe that NC762 has the potential to treat multiple tumor types. Our research indicates that NC762 inhibits tumor cell growth independently of immune cell infiltration in the tumor microenvironment.
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
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
| Year Ended | ||||||||
| 2020 | 2019 | |||||||
| Revenue: | ||||||||
| Revenue from former research and development arrangement | $ | 22,378 | $ | 6,347 | ||||
| Operating expenses: | ||||||||
| Research and development | 46,554 | 34,216 | ||||||
| General and administrative | 17,049 | 9,613 | ||||||
| Total operating expenses | 63,603 | 43,829 | ||||||
| Loss from operations | (41,225 | ) | (37,482 | ) | ||||
| Other income, net | 4,622 | 3,745 | ||||||
| Net loss | $ | (36,603 | ) | $ | (33,737 | ) | ||
| Loss per share: | ||||||||
| Net loss per common share—basic and diluted | $ | (1.33 | ) | $ | (2.15 | ) | ||
| Weighted average number of common shares —basic and diluted | 27,532,177 | 15,695,461 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (36,603 | ) | $ | (33,737 | ) | ||
| Unrealized gain (loss) on marketable securities | 779 | (38 | ) | |||||
| Total comprehensive loss | $ | (35,824 | ) | $ | (33,775 | ) | ||
BALANCE SHEETS
(in thousands, except share and per share amounts)
| 2020 | 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 32,772 | $ | 34,091 | ||||
| Marketable securities | 250,676 | 300,514 | ||||||
| Restricted cash | 1,706 | 1,706 | ||||||
| Prepaid expenses and other current assets | 2,824 | 3,684 | ||||||
| Total current assets | 287,978 | 339,995 | ||||||
| Property and equipment, net | 15,809 | 12,090 | ||||||
| Other assets | 2,857 | 4,083 | ||||||
| Total assets | $ | 306,644 | $ | 356,168 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,901 | $ | 1,861 | ||||
| Accrued liabilities | 4,627 | 4,871 | ||||||
| Deferred rent, current portion | 130 | 215 | ||||||
| Term loan, current portion | 1,667 | 1,667 | ||||||
| Deferred revenue, current portion | — | 6,428 | ||||||
| Total current liabilities | 10,325 | 15,042 | ||||||
| Deferred rent, net of current portion | 792 | 359 | ||||||
| Term loan, net of current portion | 1,806 | 3,333 | ||||||
| Deferred revenue, net of current portion | — | 15,950 | ||||||
| Total liabilities | 12,923 | 34,684 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, par value of |
— | — | ||||||
| Common stock, par value of |
28 | 27 | ||||||
| Additional paid-in capital | 410,551 | 402,529 | ||||||
| Accumulated other comprehensive income (loss) | 779 | (38 | ) | |||||
| Accumulated deficit | (117,637 | ) | (81,034 | ) | ||||
| Total stockholders’ equity | 293,721 | 321,484 | ||||||
| Total liabilities and stockholders’ equity | $ | 306,644 | $ | 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