NextCure Provides Business Update and Reports Second Quarter 2024 Financial Results
2024年8月2日 - 5:05AM
– 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 second-quarter 2024
financial results.
“Following the release of Phase 1b data for the combination of
NC410 and pembrolizumab at ASCO, we have completed enrollment of
additional ovarian cancer patients, and we look forward to sharing
results from the expanded ovarian cohort later this year,” said
Michael Richman, president and CEO of NextCure. “We also continue
to make important progress with our promising B7-H4 antibody-drug
conjugate program, LNCB74, including the completion of GLP
toxicology studies in July. We remain on track to submit an IND
filing by year-end and rapidly advance into clinical development.
NextCure is well capitalized to continue executing on our strategic
priorities, with cash reserves expected to fund operations into the
second half of 2026.”
Business Highlights and Near-Term
Milestones
NC410 (LAIR-2 fusion)
- Completed enrollment in June 2024 of an additional 16 ovarian
cancer patients among the 100 mg and 200 mg cohorts of the Phase 1b
portion of a Phase 1b/2 study evaluating NC410 in combination with
pembrolizumab (pembro) in colorectal cancer (CRC) and ovarian
cancer patients.
- Clinical data from the Phase 1b portion of the trial was
presented at the American Society of Clinical Oncology (ASCO)
Annual Meeting in June 2024.
- On track to present data from ongoing ovarian cancer cohort
expansion along with an update on the CRC data in the fourth
quarter of 2024.
LNCB74 (B7-H4 ADC)
- Recently completed GLP toxicology studies.
- Presented a poster highlighting strong safety and
pharmacokinetic profiles for LNCB74 at the 2024 American
Association for Cancer Research (AACR) Annual Meeting.
- Planned submission of an Investigational New Drug (IND)
application by year-end.
NC181 (APOE4)
- Presented “NC181: First-in-class Approach to Treat Alzheimer’s
Disease” at the H.C. Wainwright 5th Annual Neuro Perspectives
Virtual Conference.
- Initiated manufacturing of material for toxicology
studies.
- Seeking partnering or other funding sources with the potential
to file an IND mid-2025.
NC605 (Siglec-15)
- Conducted FDA pre-IND meeting related to treating osteogenesis
imperfecta.
- Toxicology studies are ongoing; seeking partnering or other
funding sources with the potential to file an IND in the second
half of 2025.
Financial Results for Quarter Ended June 30,
2024
- Cash, cash equivalents, and marketable securities as of June
30, 2024 were $86.4 million as compared to $108.3 million as of
December 31, 2023. The decrease of $21.9 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 $12.4 million for the
three months ended June 30, 2024, as compared to $13.4 million for
the three months ended June 30, 2023. Net costs on the LNCB74
program were more than offset by lower costs on other programs and
preclinical development and lower personnel-related costs.
- General and administrative expenses were $4.1 million for the
three months ended June 30, 2024, as compared to $5.7 million for
the three months ended June 30, 2023. The decrease of $1.6 million
was primarily related to payroll, lower stock compensation expense,
lower professional fees and lower insurance costs.
- Net loss was $15.4 million for the three months ended June 30,
2024, as compared to a net loss of $17.9 million for the three
months ended June 30, 2023.
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.
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Selected Financial Information |
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Selected Statement of
Operations Items: |
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
(in thousands, except share
and per share amounts) |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
12,418 |
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$ |
13,447 |
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$ |
23,816 |
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$ |
25,094 |
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General and administrative |
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4,076 |
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5,711 |
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8,440 |
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11,135 |
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Restructuring and asset impairment |
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— |
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— |
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2,542 |
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— |
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Loss from operations |
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(16,494 |
) |
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(19,158 |
) |
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(34,798 |
) |
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(36,229 |
) |
Other income, net |
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1,090 |
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1,299 |
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2,287 |
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2,274 |
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Net loss |
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$ |
(15,404 |
) |
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$ |
(17,859 |
) |
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$ |
(32,511 |
) |
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$ |
(33,955 |
) |
Net loss per common share -
basic and diluted |
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$ |
(0.55 |
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$ |
(0.64 |
) |
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$ |
(1.16 |
) |
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$ |
(1.22 |
) |
Weighted-average shares
outstanding - basic and diluted |
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27,972,744 |
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27,828,741 |
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27,937,892 |
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27,801,788 |
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Selected Balance Sheet
Items: |
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June 30, |
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December 31, |
(in thousands) |
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2024 |
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2023 |
Cash, cash equivalents, and
marketable securities |
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$ |
86,436 |
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$ |
108,299 |
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Total assets |
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$ |
102,589 |
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$ |
128,038 |
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Accounts payable and accrued
liabilities |
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$ |
10,833 |
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$ |
6,883 |
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Total stockholders'
equity |
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$ |
85,441 |
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$ |
114,421 |
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Investor InquiriesTimothy Mayer, Ph.D.NextCure,
Inc.Chief Operating Officer(240) 762-6486IR@nextcure.com
NextCure (NASDAQ:NXTC)
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