NextCure Reports Fourth Quarter and Full Year 2019 Financial Results
March 12 2020 - 5:00PM
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 fourth quarter and full
year 2019 financial results and provided a business update.
“2019 was a momentous year for NextCure, highlighted by
completing enrollment and reporting initial clinical data of the
phase 1 portion of the NC318 phase 1/2 clinical trial, initiation
of the phase 2 portion of the NC318 trial and two public
financings,” said Michael Richman, NextCure’s president and chief
executive officer. “Following the recent acceptance of our IND by
the U.S. Food and Drug Administration for our second product
candidate, NC410, we plan to initiate phase 1 clinical development
in the second quarter of 2020. We believe we are well-positioned to
continue accelerating our clinical development, advancing our
preclinical programs, and growing our manufacturing capabilities as
we pursue our goal of bringing novel immunomedicines to
patients.”
2019 Business Highlights
- Published a Nature Medicine paper with Yale University
describing Siglec-15 (S15) as a new target for immunotherapy in
March.
- Closed initial public offering (IPO) in May, raising $86.3
million in gross proceeds.
- Promoted Timothy Mayer, Ph.D., to Chief Operating Officer in
October.
- Initiated the phase 2 portion of the ongoing NC318 phase 1/2
monotherapy clinical trial in October.
- Presented positive clinical data from the phase 1 portion of
the NC318 phase 1/2 monotherapy clinical trial at the 34th Annual
Meeting of SITC in November.
- Closed follow-on offering in November, raising $172.2 million
in gross proceeds.
Upcoming Milestones
- Initiate enrollment in the phase 1 portion of our phase 1/2
clinical trial for our second product candidate, NC410, in the
second quarter of 2020.
- Initiate an NC318 combination clinical trial in NSCLC with
standard-of-care chemotherapies in mid-2020.
- Report initial data from the NC318 phase 2 monotherapy clinical
trial by the end of 2020.
Financial Results for Fourth Quarter and Full Year Ended
December 31, 2019
- Cash, cash equivalents, and marketable securities, excluding
restricted cash, as of December 31, 2019 were $334.6 million,
compared to $135.2 million as of December 31, 2018. This increase
was primarily due to $238.4 million net proceeds from public
offerings partially offset by cash used to fund operations of $35.6
million.
- Revenue from research and development arrangement was $2.0
million and $6.3 million for the three months and the full year
ended December 31, 2019, respectively. We had no revenue in 2018.
All revenue was generated from our agreement with Eli Lilly
(Lilly), which was terminated by Lilly effective March 3,
2020.
- Research and development expenses were $11.4 million and $34.2
million for the fourth quarter and full year ended December 31,
2019, respectively, as compared to $6.3 million and $19.8 million
for the comparable periods in 2018, respectively. The increases
primarily reflect a growth in headcount, NC318 clinical research
costs, lab supplies and services for NC318 and our other early
stage programs and discovery activities, as well as, in the case of
the increase for the full year ended December 31, 2019, a one-time
license payment in connection with our IPO in the quarter
ended June 30, 2019.
- General and administrative expenses were $2.6 million and $9.6
million for the fourth quarter and full year ended December 31,
2019, respectively, as compared to $0.8 million and $3.4 million,
respectively, for the comparable periods in 2018. The increases
were primarily related to increases in professional fees and
insurance costs in connection with becoming a publicly traded
company, as well as growth in headcount and, in the case of the
increase for the full year ended December 31, 2019, an unrestricted
gift to an academic lab in the quarter ended June 30, 2019.
- Net loss was $10.9 million for the fourth quarter of 2019 and
$33.7 million for the year ended December 31, 2019, as compared to
$6.9 million and $22.8 million, respectively, for the comparable
periods in 2018.
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 novel immunomedicine that
was developed to block LAIR-1-mediated immune suppression by
mimicking the natural decoy effects of LAIR-2. LAIR-1 is a
co-inhibitory receptor expressed on T cells and dendritic cells.
LAIR-2 is a naturally occurring soluble decoy protein for LAIR-1.
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 to promote 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
strength of NextCure’s financial position to continue advancing its
product candidates, the progress and expected timing of NextCure’s
ongoing clinical trial of NC318, planned clinical trials of NC318
and NC410 and other research and development programs, 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: NextCure’s limited operating history and no
products approved for commercial sale; NextCure’s history of
significant losses; 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
LOSS(unaudited, in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
December 31, |
|
|
2019 |
|
2018 |
Revenue: |
|
|
|
|
|
|
Revenue from research and development arrangement |
|
$ |
6,347 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
34,216 |
|
|
|
19,787 |
|
General and administrative |
|
|
9,613 |
|
|
|
3,409 |
|
Total operating expenses |
|
|
43,829 |
|
|
|
23,196 |
|
Loss from operations |
|
|
(37,482 |
) |
|
|
(23,196 |
) |
Other income, net |
|
|
3,745 |
|
|
|
397 |
|
Net loss |
|
|
(33,737 |
) |
|
|
(22,799 |
) |
Net loss per common share — basic and diluted |
|
$ |
(2.15 |
) |
|
$ |
(16.64 |
) |
Weighted average number of common shares — basic and diluted |
|
|
15,695,461 |
|
|
|
1,369,846 |
|
Comprehensive loss: |
|
|
|
|
|
|
Net loss |
|
|
(33,737 |
) |
|
|
(22,799 |
) |
Unrealized loss on marketable securities |
|
|
(38 |
) |
|
|
— |
|
Total comprehensive loss |
|
$ |
(33,775 |
) |
|
$ |
(22,799 |
) |
|
|
|
|
|
|
|
|
|
NEXTCURE, INC.CONDENSED
BALANCE SHEETS(unaudited, in
thousands, except share and per share
amounts)
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2019 |
|
2018 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
34,091 |
|
|
$ |
135,173 |
|
Marketable securities |
|
|
300,514 |
|
|
|
— |
|
Restricted cash |
|
|
1,706 |
|
|
|
460 |
|
Prepaid expenses and other current assets |
|
|
3,684 |
|
|
|
152 |
|
Total current assets |
|
|
339,995 |
|
|
|
135,785 |
|
Property and equipment, net |
|
|
12,090 |
|
|
|
11,407 |
|
Other assets |
|
|
4,083 |
|
|
|
436 |
|
Total assets |
|
$ |
356,168 |
|
|
$ |
147,628 |
|
Liabilities,
Preferred Stock and Stockholders’ Equity
(Deficit) |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,861 |
|
|
$ |
2,483 |
|
Accrued liabilities |
|
|
4,871 |
|
|
|
2,411 |
|
Deferred rent, current portion |
|
|
215 |
|
|
|
28 |
|
Term loan, current portion |
|
|
1,667 |
|
|
|
387 |
|
Deferred revenue, current portion |
|
|
6,428 |
|
|
|
4,989 |
|
Total current liabilities |
|
|
15,042 |
|
|
|
10,298 |
|
Deferred rent, net of current portion |
|
|
359 |
|
|
|
242 |
|
Term loan, net of current portion |
|
|
3,333 |
|
|
|
73 |
|
Deferred revenue, net of current portion |
|
|
15,950 |
|
|
|
21,736 |
|
Total liabilities |
|
|
34,684 |
|
|
|
32,349 |
|
Redeemable preferred
stock: |
|
|
|
|
|
|
Series A Preferred Stock, par value of $0.001 per share; 0 and
68,181,819 shares authorized, issued and outstanding at December
31, 2019 and 2018, respectively |
|
|
— |
|
|
|
71,000 |
|
Series B Preferred Stock, par value $0.001 per share; 0 and
56,828,852 shares authorized at December 31, 2019 and 2018,
respectively, 0 and 56,828,851 shares issued and outstanding at
December 31, 2019 and 2018, respectively |
|
|
— |
|
|
|
91,223 |
|
Total redeemable preferred
stock |
|
|
— |
|
|
|
162,223 |
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
Preferred stock, par value of $0.001 per share; 10,000,000 and 0
shares authorized at December 31, 2019 and 2018. No shares issued
and outstanding at December 31, 2019 and 2018, respectively |
|
|
— |
|
|
|
— |
|
Common stock, par value of $0.001 per share; 100,000,000 and
158,745,671 shares authorized at December 31, 2019 and 2018,
respectively, 27,499,260 and 1,374,812 shares issued and
outstanding at December 31, 2019 and 2018, respectively |
|
|
27 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
402,529 |
|
|
|
352 |
|
Accumulated other comprehensive loss |
|
|
(38 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(81,034 |
) |
|
|
(47,297 |
) |
Total stockholders’ equity
(deficit) |
|
|
321,484 |
|
|
|
(46,944 |
) |
Total liabilities, preferred
stock and stockholders’ equity (deficit) |
|
$ |
356,168 |
|
|
$ |
147,628 |
|
|
|
|
|
|
|
|
|
|
Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
Media Inquiries
Shai Biran, Ph.D.
MacDougall
(781) 235-3060
NextCure@macbiocom.com
NextCure (NASDAQ:NXTC)
Historical Stock Chart
From Mar 2024 to Apr 2024
NextCure (NASDAQ:NXTC)
Historical Stock Chart
From Apr 2023 to Apr 2024