NextCure Reports Third Quarter 2019 Financial Results
13 November 2019 - 12:05AM
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 third quarter 2019
financial results and provided a business update.
“NextCure has made important clinical and operational progress
toward realizing our long-term vision of developing novel
immunomedicines for patients who do not respond to standard
treatments or existing immunotherapies,” said Michael Richman,
president and chief executive officer. “Completion of enrollment
and announcement of preliminary data in the Phase 1 portion of the
clinical trial with our lead program NC318 are major milestones for
NextCure. We believe that NC318 is in position to achieve further
meaningful clinical endpoints as we progress into the Phase 2
portion of the trial. We remain confident in NC318’s potential to
be a new therapy for patients with solid tumors and low levels of
PD-1 expression or who do not respond to anti-PD-1/PD-L1
treatments.”
Business Highlights
- Presented clinical data from the Phase 1 portion of the NC318
Phase 1/2 Clinical Trial at the 34th Annual Meeting of SITC.
- Initiated the Phase 2 portion of the ongoing Phase 1/2 clinical
trial of NC318.
- Promoted Timothy Mayer, Ph.D. to Chief Operating Officer.
- Continued research activities under our collaboration agreement
with Eli Lilly and Company (“Lilly”).
- Remain on track to submit an investigational new drug
application to the U.S. Food and Drug Administration for our second
product candidate, NC410, in the first quarter of 2020. NC410
is a novel immunomedicine designed to block immune suppression
mediated by an immune modulator called Leukocyte‑Associated
Immunoglobulin‑like Receptor 1, or LAIR‑1.
Financial Results for Quarter Ended September 30,
2019
- Cash, cash equivalents, and marketable securities as of
September 30, 2019 were $184.1 million, compared to $135.2 million
as of December 31, 2018. This increase primarily reflects net
proceeds from our IPO of $77.0 million, partially offset by cash
used to fund operations of $25.6 million.
- Revenue was $1.6 million and $4.3 million for the three and
nine months ended September 30, 2019, respectively. We had no
revenue in 2018. Revenue to date has been generated from the Lilly
agreement.
- Research and development expenses were $8.7 million and $22.8
million for the three and nine months ended September 30, 2019,
respectively, as compared to $4.9 million and $13.5 million for the
three and nine months ended September 30, 2018, respectively. The
increases primarily reflect an increase in headcount, NC318
clinical research costs, lab supplies and services for NC318 and
our other early stage programs and discovery activities, as well as
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 $7.0
million for the three and nine months ended September 30, 2019,
respectively as compared to $0.9 million and $2.6 million for the
three and nine months ended September 30, 2018, respectively. 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 and an
unrestricted gift to an academic lab in the prior quarter.
- Net loss was $8.4 million and $22.8 million for the three and
nine months ended September 30, 2019, respectively, as compared to
$5.7 million and $15.9 million for the three and nine months ended
September 30, 2018, respectively.
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,” “hope,” “toward,”
“progress,” “continue,” “vision,” “on track” 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 NC318and 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-Q filed with the SEC on August 12, 2019. 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from research and development arrangement |
$ |
1,583 |
|
|
$ |
— |
|
|
$ |
4,342 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
8,663 |
|
|
|
4,895 |
|
|
|
22,819 |
|
|
|
13,539 |
|
General and administrative |
|
2,622 |
|
|
|
925 |
|
|
|
6,995 |
|
|
|
2,590 |
|
Total operating expenses |
|
11,285 |
|
|
|
5,820 |
|
|
|
29,814 |
|
|
|
16,129 |
|
Loss from operations |
|
(9,702 |
) |
|
|
(5,820 |
) |
|
|
(25,472 |
) |
|
|
(16,129 |
) |
Other income, net |
|
1,268 |
|
|
|
110 |
|
|
|
2,662 |
|
|
|
192 |
|
Net loss |
|
(8,434 |
) |
|
|
(5,710 |
) |
|
|
(22,810 |
) |
|
|
(15,937 |
) |
Net loss per common share—basic and diluted |
$ |
(0.37 |
) |
|
$ |
(4.17 |
) |
|
$ |
(1.81 |
) |
|
$ |
(11.64 |
) |
Weighted average number of common shares —basic and diluted |
|
22,715,567 |
|
|
|
1,369,212 |
|
|
|
12,609,219 |
|
|
|
1,369,212 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on marketable securities |
|
(58 |
) |
|
|
— |
|
|
|
(58 |
) |
|
|
— |
|
Total comprehensive loss |
$ |
(8,492 |
) |
|
$ |
(5,710 |
) |
|
$ |
(22,868 |
) |
|
$ |
(15,937 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NEXTCURE, INC.CONDENSED
BALANCE SHEETS(unaudited, in
thousands, except share and per share
amounts)
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
2019 |
|
2018 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
9,935 |
|
$ |
135,173 |
Marketable securities |
|
174,147 |
|
|
— |
Restricted cash |
|
1,289 |
|
|
460 |
Prepaid expenses and other current assets |
|
3,777 |
|
|
152 |
Total current assets |
|
189,148 |
|
|
135,785 |
Property and equipment, net |
|
12,031 |
|
|
11,407 |
Other assets |
|
3,945 |
|
|
436 |
Total assets |
$ |
205,124 |
|
$ |
147,628 |
Liabilities, Preferred
Stock and Stockholders’ Equity (Deficit) |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
2,576 |
|
$ |
2,483 |
Accrued liabilities |
|
2,582 |
|
|
2,411 |
Deferred rent, current portion |
|
— |
|
|
28 |
Term loan, current portion |
|
1,250 |
|
|
387 |
Deferred revenue, current portion |
|
6,199 |
|
|
4,989 |
Total current liabilities |
|
12,607 |
|
|
10,298 |
Deferred rent, net of current portion |
|
434 |
|
|
242 |
Term loan, net of current portion |
|
3,750 |
|
|
73 |
Deferred revenue, net of current portion |
|
17,684 |
|
|
21,736 |
Total liabilities |
|
34,475 |
|
|
32,349 |
Commitments and
contingencies |
|
|
|
|
|
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 September
30, 2019 and December 31, 2018, respectively |
|
— |
|
|
71,000 |
Series B Preferred Stock, par value $0.001 per share; 0 and
56,828,852 shares authorized at September 30, 2019 and December 31,
2018, respectively, 0 and 56,828,851 shares issued and outstanding
at September 30, 2019 and December 31, 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 September 30, 2019 and December 31, 2018. No
shares issued and outstanding at September 30, 2019 and December
31, 2018, respectively |
|
— |
|
|
— |
Common stock, par value of $0.001 per share; 100,000,000 and
158,745,671 shares authorized at September 30, 2019 and December
31, 2018, respectively, 22,739,345, and 1,374,812 shares issued and
outstanding at September 30, 2019 and December 31, 2018,
respectively |
|
23 |
|
|
1 |
Additional paid-in capital |
|
240,791 |
|
|
352 |
Accumulated other comprehensive loss |
|
(58) |
|
|
— |
Accumulated deficit |
|
(70,107) |
|
|
(47,297) |
Total stockholders’ equity
(deficit) |
|
170,649 |
|
|
(46,944) |
Total liabilities, preferred
stock and stockholders’ equity (deficit) |
$ |
205,124 |
|
$ |
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
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