NextCure Provides Business Update and Reports First Quarter 2024 Financial Results
02 Mai 2024 - 10:05PM
NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical
company committed to discovering and developing novel,
first-in-class, and best-in-class therapies to treat cancer, today
provided a business update and reported its first-quarter 2024
financial results.
“We look forward to providing an update on the NC410 combo trial
at the ASCO Annual Meeting, which will include data from the
additional colorectal patients enrolled earlier this year," said
Michael Richman, NextCure’s president and chief executive officer.
“LNCB74, our B7-H4 ADC program, is advancing to a planned IND
submission by year-end. GLP toxicology studies have been initiated
and clinical material is being produced.”
Business Highlights and Near-Term
Milestones
NC410 (LAIR-2 fusion)
- Scheduled to present a poster at the American Society of
Clinical Oncology (ASCO) Annual Meeting on June 1st, highlighting
clinical data from the Phase 1b study of NC410 in combination with
pembrolizumab (pembro) in colorectal cancer (CRC) and ovarian
cancer patients.
- Included in the ASCO poster presentation will be the additional
20 CRC patients in the 100 mg cohort enrolled in January 2024.
- Commenced enrolling additional ovarian cancer patients in March
2024 and plan to present data in the second half of 2024.
LNCB74 (B7-H4 ADC)
- Presented a poster highlighting strong safety and
pharmacokinetic profiles for LNCB74 at the 2024 American
Association for Cancer Research (AACR) Annual Meeting.
- Manufactured the monoclonal antibody intermediate and commenced
clinical material production with our collaborator, LigaChem
Biosciences (LCB), formerly LegoChem Biosciences.
- Planned submission of an investigational new drug application
by year-end.
Financial Results for Quarter Ended March 31,
2024
- Cash, cash equivalents, and marketable securities as of March
31, 2024, were $96.0 million as compared to $108.3 million as of
December 31, 2023. The decrease of $12.3 million was primarily due
to cash used to fund operations. NextCure expects financial
resources to fund operating expenses and capital expenditures into
the second half of 2026.
- Research and development expenses were $11.4 million for the
three months ended March 31, 2024, as compared to $11.6 million for
the three months ended March 31, 2023. Higher costs associated with
increased patient enrollment in our phase 1b combination trial of
NC410 were offset by reimbursements under our cost-sharing
agreement with LigaChem and lower personnel-related costs.
- General and administrative expenses were $4.4 million for the
three months ended March 31, 2024, as compared to $5.4 million for
the three months ended March 31, 2023. The decrease of $1.0 million
was primarily related to lower personnel-related costs and lower
insurance costs.
- Restructuring and asset impairment costs associated with our
reduction in workforce and the manufacturing pause announced in
March 2024 totaled $2.5 million.
- Net loss was $17.1 million for the three months ended March 31,
2024, as compared with a net loss of $16.1 million for the three
months ended March 31, 2023. Lower general and administrative
expenses and higher other income were offset by restructuring and
impairment costs.
About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company that is
focused on advancing innovative medicines that treat cancer
patients that do not respond, to or have disease progression on,
current therapies, through the use of differentiated mechanisms of
actions including antibody-drug conjugates, antibodies and
proteins. We focus on advancing therapies that leverage our core
strengths in understanding biological pathways and biomarkers, the
interactions of cells, including in the tumor microenvironment, and
the role each interaction plays in a biologic response.
www.nextcure.com
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
funding for our operations, objectives and expectations for our
business, operations and financial performance and condition,
including the progress and results of clinical trials, development
plans and upcoming milestones regarding our therapies. 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: positive results in
preclinical studies may not be predictive of the results of
clinical trials; NextCure’s limited operating history and not
having any products approved for commercial sale; NextCure’s
history of significant losses; NextCure’s need and ability to
obtain additional financing on acceptable terms or at all; risks
related to clinical development, marketing approval and
commercialization; and NextCure’s 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 NextCure’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.
Selected Financial Information |
|
|
|
|
|
|
Selected Statement of
Operations Items: |
Three Months Ended |
|
March 31, |
(in thousands, except share
and per share amounts) |
2024 |
|
2023 |
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
11,398 |
|
|
$ |
11,647 |
|
General and administrative |
|
4,364 |
|
|
|
5,424 |
|
Restructuring and asset impairment |
|
2,542 |
|
|
|
- |
|
Loss from operations |
|
(18,304 |
) |
|
|
(17,071 |
) |
Other income, net |
|
1,197 |
|
|
|
975 |
|
Net loss |
$ |
(17,107 |
) |
|
$ |
(16,096 |
) |
Net loss per common share -
basic and diluted |
$ |
(0.61 |
) |
|
$ |
(0.58 |
) |
Weighted-average shares
outstanding - basic and diluted |
|
27,903,040 |
|
|
|
27,774,536 |
|
|
|
|
|
|
|
Selected Balance Sheet
Items: |
|
|
|
|
|
|
March 31, |
|
December 31, |
(in thousands) |
2024 |
|
2023 |
Cash, cash equivalents, and
marketable securities |
$ |
96,001 |
|
|
$ |
108,299 |
|
Total assets |
$ |
115,159 |
|
|
$ |
128,038 |
|
Accounts payable and accrued
liabilities |
$ |
9,583 |
|
|
$ |
6,883 |
|
Total stockholders'
equity |
$ |
99,048 |
|
|
$ |
114,421 |
|
|
|
|
|
|
|
|
|
Investor InquiriesTimothy Mayer, Ph.D.NextCure,
Inc.Chief Operating Officer(240) 762-6486IR@nextcure.com
NextCure (NASDAQ:NXTC)
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