NextCure Reports First Quarter 2020 Financial Results
May 07 2020 - 5:10PM
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 reported first quarter 2020
financial results and provided a business update.
“Throughout the first quarter, NextCure continued to make
progress on its pipeline of novel immunomedicines, and we plan to
present the initial biomarker data from our Phase 1 portion of the
NC318 Phase 1/2 monotherapy clinical trial at the American Society
of Clinical Oncology (ASCO) Annual Meeting this month,” said
Michael Richman, NextCure’s president and chief executive officer.
“We filed an IND for our second product candidate and received FDA
clearance for clinical studies in the first quarter. In addition,
we were prepared to initiate the Phase 1 portion of a Phase 1/2
clinical trial in March; however, the COVID-19 pandemic required us
to temporarily delay initiating that trial and adjust some other
timelines. We look forward to starting the NC410 trial when matters
improve.”
“We remain highly committed to our goal of bringing novel
immunomedicines to patients by advancing our clinical and
preclinical programs while leveraging our innovative FIND-IO
platform,” added Mr. Richman.
Business Highlights and Upcoming Milestones
- Filed an Investigational New Drug (IND) application for the
NC410 program and received FDA clearance for clinical studies.
- Appointed veteran oncology executive Garry Nicholson to
NextCure’s Board of Directors.
- Will report initial biomarker data from the Phase 1 portion of
the NC318 Phase 1/2 monotherapy clinical trial at the virtual ASCO
Annual Meeting in late May 2020.
- The following milestones were temporarily delayed by the
COVID-19 pandemic and will be updated subject to further
developments:
- Initiate enrollment in the phase 1 portion of our phase 1/2
clinical trial for our second product candidate, NC410.
- Initiate an NC318 combination clinical trial in NSCLC with
standard-of-care chemotherapies.
- Given enrollment slowdown due to the COVID-19 pandemic, initial
data reporting from the Phase 2 portion of the Phase 1/2 NC318
monotherapy clinical trial is expected to be delayed.
Financial Results for Quarter Ended March 31,
2020
- Cash, cash equivalents, and marketable securities, excluding
restricted cash, as of March 31, 2020 were $322.1 million, as
compared to $334.6 million as of December 31, 2019. The decrease of
$12.5 million primarily reflects cash used to fund operations of
$10.6 million and cash used to purchase fixed assets of $1.5
million.
- Revenue was $22.4 million for the quarter ended March 31, 2020,
as compared to $1.4 million for the quarter ended March 31, 2019.
Revenue was generated from our former research and development
agreement with Eli Lilly (Lilly), which was terminated by Lilly
effective March 3, 2020, resulting in the recognition of all
remaining deferred revenue related to the agreement in the first
quarter of 2020.
- Research and development expenses were $10.6 million for the
quarter ended March 31, 2020 as compared to $6.5 million for the
quarter ended March 31, 2019. The increases primarily reflect an
increase in headcount, clinical research costs for NC318 and NC410,
lab supplies and services for NC318, NC410 and our other early
stage programs, and discovery activities.
- General and administrative expenses were $3.6 million for the
quarter ended March 31, 2020, as compared to $1.7 million for the
quarter ended March 31, 2019. The increase was primarily related to
increases in professional fees and insurance costs in connection
with becoming a publicly traded company, as well as increases in
personnel-related costs.
- Net income was $9.7 million for the quarter ended March 31,
2020, resulting from the recognition of the remaining deferred
revenue under the former agreement with Lilly, as compared to a net
loss of $6.2 million for the quarter ended March 31, 2019.
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. NextCure
believes NC318 has the potential to treat multiple cancer
types.
About NC410NC410 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. NextCure believes NC410 has the potential to treat
multiple cancer types.
About NextCure, Inc.NextCure is a
clinical-stage biopharmaceutical company committed to discovering
and developing novel, first-in-class immunomedicines to treat
cancer and other immune-related diseases. 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
initial 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 StatementsThis 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 NextCure as of the date hereof. Forward-looking
statements include statements regarding NextCure’s expectations,
beliefs, intentions or strategies regarding the future and can be
identified by forward-looking words such as “may,” “will,”
“potential,” “expects,” “believes,” “intends,” “forward,”
“progress,” “continue,” “momentum,” “well-positioned,” “upcoming”
and similar expressions. Examples of forward-looking statements in
this press release include, among others, statements about the
progress and expected timing of NextCure’s ongoing clinical trial
of NC318 and planned clinical trials of NC318 and NC410, the impact
of the COVID-19 pandemic on the initiation, progress or expected
timing of those trials and the timing of related data, NextCure’s
efforts to adjust trial-related activities to address the impact of
the COVID-19 pandemic, NextCure’s plans for further updates related
to the impact of the COVID-19 pandemic, and NextCure’s plans,
objectives and intentions with respect to the discovery and
development of immunomedicines. 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: the
impacts of the ongoing COVID-19 pandemic on NextCure’s business,
including NextCure’s clinical trials, third parties on which
NextCure relies and NextCure’s operations; NextCure’s limited
operating history and no products approved for commercial sale;
NextCure’s need to obtain additional financing; risks related to
clinical development, marketing approval and commercialization; and
the unproven approach to the discovery and development of product
candidates based on NextCure’s FIND-IO platform. More detailed
information on these and additional factors that could affect
NextCure’s actual results are described in NextCure’s filings with
the Securities and Exchange Commission (the “SEC”), including
NextCure’s Form 10-K filed with the SEC on March 12, 2020. 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.
NEXTCURE, INC.CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(unaudited, in thousands, except share and per share
amounts)
|
|
Three Months Ended |
|
March 31, |
|
|
2020 |
|
2019 |
Revenue: |
|
|
|
|
|
|
Revenue from research and development arrangement |
|
$ |
22,378 |
|
$ |
1,357 |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
10,578 |
|
|
6,513 |
General and administrative |
|
|
3,588 |
|
|
1,659 |
Total operating expenses |
|
|
14,166 |
|
|
8,172 |
Income (loss) from
operations |
|
|
8,212 |
|
|
(6,815) |
Other income, net |
|
|
1,521 |
|
|
660 |
Net income (loss) |
|
$ |
9,733 |
|
$ |
(6,155) |
Earnings (loss) per share |
|
|
|
|
|
|
Basic |
|
$ |
0.35 |
|
$ |
(4.46) |
Diluted |
|
$ |
0.33 |
|
$ |
(4.46) |
Shares used in the calculation
of earnings (loss) per share |
|
|
|
|
|
|
Basic |
|
|
27,506,927 |
|
|
1,379,444 |
Diluted |
|
|
29,348,615 |
|
|
1,379,444 |
Comprehensive income
(loss): |
|
|
|
|
|
|
Net income (loss) |
|
$ |
9,733 |
|
$ |
(6,155) |
Unrealized loss on marketable securities |
|
|
(543) |
|
|
— |
Comprehensive income
(loss) |
|
$ |
9,190 |
|
$ |
(6,155) |
NEXTCURE, INC.CONDENSED
BALANCE SHEETS(unaudited, in thousands, except
share and per share amounts)
|
|
March 31, |
|
December 31, |
|
|
2020 |
|
2019 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
28,907 |
|
$ |
34,091 |
Marketable securities |
|
|
293,191 |
|
|
300,514 |
Restricted cash |
|
|
1,706 |
|
|
1,706 |
Prepaid expenses and other current assets |
|
|
2,860 |
|
|
3,684 |
Total current assets |
|
|
326,664 |
|
|
339,995 |
Property and equipment, net |
|
|
12,784 |
|
|
12,090 |
Other assets |
|
|
4,024 |
|
|
4,083 |
Total assets |
|
$ |
343,472 |
|
$ |
356,168 |
Liabilities, Preferred
Stock and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,263 |
|
$ |
1,861 |
Accrued liabilities |
|
|
4,059 |
|
|
4,871 |
Deferred rent, current portion |
|
|
163 |
|
|
215 |
Term loan, current portion |
|
|
1,667 |
|
|
1,667 |
Deferred revenue, current portion |
|
|
— |
|
|
6,428 |
Total current liabilities |
|
|
8,152 |
|
|
15,042 |
Deferred rent, net of current portion |
|
|
507 |
|
|
359 |
Term loan, net of current portion |
|
|
3,056 |
|
|
3,333 |
Deferred revenue, net of current portion |
|
|
— |
|
|
15,950 |
Total liabilities |
|
|
11,715 |
|
|
34,684 |
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, par value of $0.001 per share; 10,000,000 shares
authorized at March 31, 2020 and December 31, 2019, respectively.
No shares issued and outstanding at March 31, 2020 and December 31,
2019, respectively |
|
|
— |
|
|
— |
Common stock, par value of $0.001 per share; 100,000,000 shares
authorized at March 31, 2020 and December 31, 2019, respectively,
27,516,402 and 27,499,260 shares issued and outstanding at March
31, 2020 and December 31, 2019, respectively |
|
|
28 |
|
|
27 |
Additional paid-in capital |
|
|
403,573 |
|
|
402,529 |
Accumulated other comprehensive loss |
|
|
(543) |
|
|
(38) |
Accumulated deficit |
|
|
(71,301) |
|
|
(81,034) |
Total stockholders’
equity |
|
|
331,757 |
|
|
321,484 |
Total liabilities, preferred
stock and stockholders’ equity |
|
$ |
343,472 |
|
$ |
356,168 |
Investor InquiriesTimothy Mayer, Ph.D.NextCure,
Inc.Chief Operating Officer(240) 762-6486IR@nextcure.com
Media InquiriesShai Biran, Ph.D.MacDougall(781)
235-3060NextCure@macbiocom.com
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