NextCure Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results
- Multiple data readouts expected in 2022, including updates for all three clinical programs
- Ends 2021 with cash position of
$219.6 millionthat is expected to fund operations into first quarter of 2024
- Combined Phase 1 and 2 data presented at the
Society for Immunotherapy of Cancer(SITC) Annual Meeting showed early evidence of potential clinical benefit in patients with lung cancer, squamous cell carcinoma of the head and neck, breast cancer and other advanced/metastatic solid tumors.
- Preclinical data presented at the
American Society of Hematology(ASH) Annual Meeting suggest that Siglec-15 (S15) may be targeted therapeutically with compounds such as NC318 to activate T lymphocytes against leukemia cells. Knock-out of S15 in a murine model resulted in leukemia clearance in immunocompetent recipients and 100% survival across all recipients.
- Combined Phase 1 and 2 data presented at the
- Interim Phase 1 data presented at the SITC Annual Meeting showed that NC410 appears to be safe and well-tolerated in patients with advanced tumors and demonstrated evidence of immune modulation.
- Preclinical data published in the online journal Frontiers in Immunology indicated that collagen fragments in the tumor microenvironment (TME) can mediate T cell suppression through LAIR-1, and this suppression could subsequently be reversed by a LAIR-2 fusion protein like NC410.
- Continued to enroll patients and advance the program to report initial Phase 1 clinical data in the second half of 2022.
- Introduced our fourth program, which targets LAIR-1 expression with a novel mechanism of action that kills acute myeloid leukemia (AML) blasts and leukemia stem cells with minimal effect on hematopoietic stem and progenitor cells.
- Preclinical data presented at the ASH Annual Meeting appear to show that NC525 could preferentially target and kill LAIR-1 expressing AML stem cells with minimal effect on healthy hematopoietic stem and progenitor cells.
Ellen G. Feigal, M.D., a Partner and Head of the Biologics Practice at NDA Partners LLC, and Anne Borgman, M.D., former Vice President and Global Therapeutic Area Lead, Hematology-Oncology, at Jazz Pharmaceuticals, to the Board of Directors.
Elizabeth Jaffee, M.D., Ursula Matulonis, M.D., and Weiping Zou, M.D., Ph.D., to the NextCure Scientific Advisory Board.
Expected Upcoming Milestones
The widespread impact of the COVID-19 pandemic, including the emergence of the Omicron variant, has impacted enrollment and operations at certain clinical trial sites involved in NextCure’s ongoing trials. As a result, some milestones have been delayed.
- NC318 Phase 2 update: fourth quarter of 2022 (Amended Phase 2: S15+ selection with CLIA assay, 800 mg dosed Q1W).
- NC318 anti-PD-1 Combo (Yale University Investigator-Initiated trial): second half of 2022.
- NC410 Phase 1 update: second half of 2022.
- NC762 initial Phase 1 data: second half of 2022.
- NC525 Investigational New Drug Application (IND) filing: fourth quarter of 2022.
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 expenditures into the first quarter of 2024.
Financial Results for Fourth Quarter and Full Year Ended December 31, 2021
- Cash, cash equivalents, and marketable securities, excluding restricted cash as of December 31, 2021, were $219.6 million as compared with $283.4 million as of December 31, 2020. The decrease of $63.8 million as of December 31, 2021, as compared to December 31, 2020, primarily reflects cash used to fund operations of $57.2 million.
- Research and development expenses were $50.2 million and $12.3 million for the year and quarter ended December 31, 2021, respectively, as compared with $46.6 million and $12.1 million for the year and quarter ended December 31, 2020, respectively. The increase was driven primarily by clinical-related and personnel-related costs, partially offset by timing of research and manufacturing supply costs.
- General and administrative expenses were $20.6 million and $4.8 million for the year and quarter ended December 31, 2021, respectively, as compared with $17.0 million and $4.1 million for the year and quarter ended December 31, 2020, respectively. The increase was primarily related to personnel-related costs.
- Revenue was not recognized for the year ended
December 31, 2021, as compared with $22.4 million for the year ended December 31, 2020. Revenue generated in 2020 was from our former research and development agreement with Eli Lilly.
- Net loss was
$69.4 millionand $16.9 millionfor the year and quarter ended December 31, 2021, respectively, as compared with $36.6 million and $15.5 million for the year and quarter ended December 31, 2020, respectively. The changes in net loss for the year and quarter were primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount, offset by the recognition for the year ended 2020 of the remaining deferred revenue under the former research and development agreement with Eli Lilly.
About NextCure, Inc.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements, including statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts, assumptions and other information available to
Chief Operating Officer
|Selected Financial Information|
|Selected Statement of Operations Items:||Year Ended|
|(in thousands, except share and per share amounts)||2021||2020|
|Revenue from former research and development arrangement||$||$||22,378|
|Research and development||50,192||46,554|
|General and administrative||20,573||17,049|
|Loss from operations||(70,765||)||(41,225||)|
|Other income, net||1,376||4,622|
|Net loss per common share - basic and diluted||$||(2.51||)||$||(1.33||)|
|Weighted-average shares outstanding - basic and diluted||27,615,977||27,532,177|
|Selected Balance Sheet Items:||Year Ended|
|Cash, cash equivalents, and marketable securities||$||219,591||$||283,448|
|Accounts payable and accrued expenses||6,391||8,528|
|Total stockholder's equity||233,386||293,721|