NextCure Provides Business Update and Reports Second Quarter 2023 Financial Results
August 03 2023 - 4:05PM
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 provided a business update and
reported second quarter 2023 financial results.
“As we enter the remainder of 2023, we continue
generating important data and are nearing updates on our clinical
programs expected in the fourth quarter of this year,” said Michael
Richman, NextCure’s president and chief executive officer. “We
expect to continue to advance our programs while prudently managing
our resources to support our financial runway into mid-2025.”
Q2 2023 Business Highlights and Near-Term
Milestones
NC410 (LAIR-2 fusion)
- Continued enrollment in the Phase 1b/2 clinical trial
evaluating NC410 in combination with pembrolizumab in patients with
immune checkpoint naive or checkpoint refractory solid tumors.
- Phase 1b data are expected in the fourth quarter of 2023.
NC762 (B7-H4 mAb)
- Continued enrollment in the Phase 1b dose expansion study in
patients with solid tumors and high expression of B7-H4.
- Phase 1b update is expected in the fourth quarter of 2023.
NC525 (LAIR-1 mAb)
- Continued enrollment in the Phase 1 monotherapy dose escalation
and safety study evaluating NC525 in AML patients.
- Phase 1a update is expected in the fourth quarter of 2023.
NC318 (Siglec-15)
- Yale Cancer Center to present in September, “NC318, an
Anti-Siglec-15 Humanized mAb, Alone and in Combination with
Pembrolizumab in Immunotherapy Pretreated NSCLC”, at the
International Association for the Study of Lung Cancer 2023 World
Conference on Lung Cancer in Singapore.
Financial Guidance
- NextCure expects its existing
cash, cash equivalents and marketable securities will enable it to
fund operating expenses and capital expenditures into
mid-2025.
Financial Results for Quarter Ended June
30, 2023
- Cash, cash equivalents, and marketable securities as of June
30, 2023, were $130.6 million as compared to $159.9 million as of
December 31, 2022. The decrease of $29.3 million was primarily
related to cash used to fund operations, and cash used to purchase
fixed assets.
- Research and development expenses were $13.4 million for the
quarter ended June 30, 2023, as compared to $12.8 million for the
quarter ended June 30, 2022. The increase of $0.6 million was
primarily related to higher clinical costs.
- General and administrative expenses were $5.7 million for the
quarter ended June 30, 2023, as compared to $5.3 million for the
quarter ended June 30, 2022. The increase of $0.4 million was
primarily related to higher payroll and legal costs partially
offset by lower stock compensation costs and lower insurance
costs.
- Net loss was $17.9 million for the quarter ended June 30, 2023,
as compared with a net loss of $17.9 million for the quarter ended
June 30, 2022. Higher research and development expenses and higher
general and administrative expenses were offset by higher other
income, primarily interest income.
About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical
company committed to discovering and developing novel,
first-in-class immunomedicines and other immune related-diseases to
treat cancer. 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 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
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
immunomedicines. 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; the unproven approach to the discovery and
development of product candidates based on NextCure’s FIND-IO
platform; 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 |
|
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|
|
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Selected Statement of Operations Items: |
Three Months
Ended |
|
Six Months
Ended |
|
June 30, |
|
June 30, |
(in
thousands, except share and per share amounts) |
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
13,447 |
|
|
$ |
12,825 |
|
|
$ |
25,094 |
|
|
$ |
27,849 |
|
General and administrative |
|
5,711 |
|
|
|
5,303 |
|
|
|
11,135 |
|
|
|
11,050 |
|
Loss from
operations |
|
(19,158 |
) |
|
|
(18,128 |
) |
|
|
(36,229 |
) |
|
|
(38,899 |
) |
Other
income, net |
|
1,299 |
|
|
|
208 |
|
|
|
2,274 |
|
|
|
377 |
|
Net
loss |
$ |
(17,859 |
) |
|
$ |
(17,920 |
) |
|
$ |
(33,955 |
) |
|
$ |
(38,522 |
) |
Net loss per
common share - basic and diluted |
$ |
(0.64 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.22 |
) |
|
$ |
(1.39 |
) |
Weighted-average shares outstanding - basic and diluted |
|
27,828,741 |
|
|
|
27,744,762 |
|
|
|
27,801,788 |
|
|
|
27,726,864 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Balance Sheet Items: |
|
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|
|
|
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|
|
|
|
|
|
|
|
June 30, |
|
|
|
December 31, |
|
(in
thousands) |
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
Cash, cash
equivalents, and marketable securities |
|
|
|
|
|
|
$ |
130,623 |
|
|
$ |
159,911 |
|
Total
assets |
|
|
|
|
|
|
$ |
153,380 |
|
|
$ |
184,161 |
|
Accounts
payable and accrued liabilities |
|
|
|
|
|
|
$ |
7,820 |
|
|
$ |
9,127 |
|
Total
stockholders' equity |
|
|
|
|
|
|
$ |
138,430 |
|
|
$ |
167,530 |
|
Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
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