NextCure Reports Second Quarter 2019 Financial Results
August 12 2019 - 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 reported second quarter 2019
financial results and provided a business update.
“NextCure has made important progress this year
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. “The first half of 2019 has
been productive for us. We are in a strong financial position to
continue advancing our programs, and we remain on track to complete
the Phase 1 portion of our clinical study with NC318 and to present
topline data from the trial in the fourth quarter of 2019.”
Business Highlights
- Continued enrolling a Phase 1/2
clinical trial to evaluate NC318 as a monotherapy in patients with
advanced or metastatic solid tumors. The Phase 1 portion of the
trial is designed to assess the safety and tolerability of
NC318.
- Closed our initial public offering
(IPO) on May 9, 2019, raising $86.3 million in gross proceeds.
- 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 June
30, 2019
- Cash and cash equivalents as of
June 30, 2019 were $192.7 million, compared to $135.2 million as of
December 31, 2018. The increase in cash reflects net proceeds from
our IPO of $77.0, partially offset by cash used to fund operations
of $18.5 million.
- Revenue was $1.4 million and $2.8
million for the three and six months ended June 30, 2019,
respectively. We had no revenue in the calendar year 2018. Revenue
to date has been generated from the Lilly agreement.
- Research and development expenses
were $7.6 million and $14.2 million for the three and six months
ended June 30, 2019, respectively, as compared to $ 4.4 million and
$8.6 million for the three and six months ended June 30, 2018,
respectively. The increase was primarily related to an increase in
headcount, NC318 clinical research costs, lab supplies and services
for NC318, our other early stage programs and discovery activities,
and a one-time license payment in connection with our IPO.
- General and administrative expenses
were $2.7 million and $4.4 million for the three and six months
ended June 30, 2019, respectively, as compared to $0.9 million and
$1.7 million for the three and six months ended June 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.
- Net loss was $8.2 million and $14.4
million for the three and six months ended June 30, 2019,
respectively, as compared to $5.2 million and $10.2 million for the
three and six months ended June 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,” “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 study of NC318 and its 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 June 10, 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 |
(in thousands, except share and per share
amounts) |
(Unaudited) |
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
Revenue from research and development arrangement |
$ |
1,402 |
|
|
$ |
— |
|
|
$ |
2,759 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
7,643 |
|
|
|
4,434 |
|
|
|
14,156 |
|
|
|
8,644 |
|
General and administrative |
|
2,714 |
|
|
|
866 |
|
|
|
4,373 |
|
|
|
1,665 |
|
Total operating expenses |
|
10,357 |
|
|
|
5,300 |
|
|
|
18,529 |
|
|
|
10,309 |
|
Loss from operations |
|
(8,955 |
) |
|
|
(5,300 |
) |
|
|
(15,770 |
) |
|
|
(10,309 |
) |
Other income, net |
|
734 |
|
|
|
69 |
|
|
|
1,394 |
|
|
|
82 |
|
Net loss |
|
(8,221 |
) |
|
|
(5,231 |
) |
|
|
(14,376 |
) |
|
|
(10,227 |
) |
Net loss per share attributable to common stockholders—basic and
diluted |
$ |
(0.61 |
) |
|
$ |
(3.82 |
) |
|
$ |
(1.92 |
) |
|
$ |
(7.47 |
) |
Weighted average common shares outstanding—basic and diluted |
|
13,498,393 |
|
|
|
1,369,212 |
|
|
|
7,472,298 |
|
|
|
1,369,212 |
|
NEXTCURE, INC. |
CONDENSED BALANCE SHEETS |
(in thousands, except share and per share
amounts) |
|
June 30, |
|
December 31, |
|
|
2019 |
|
|
2018 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
192,689 |
|
|
$ |
135,173 |
|
|
Restricted cash |
|
873 |
|
|
|
460 |
|
|
Prepaid expenses and other current assets |
|
2,959 |
|
|
|
152 |
|
|
Total current assets |
|
196,521 |
|
|
|
135,785 |
|
|
Property and equipment, net |
|
12,329 |
|
|
|
11,407 |
|
|
Other assets |
|
4,200 |
|
|
|
436 |
|
|
Total assets |
$ |
213,050 |
|
|
$ |
147,628 |
|
|
Liabilities, Preferred Stock and Stockholders’ Equity
(Deficit) |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
$ |
1,990 |
|
|
$ |
2,483 |
|
|
Accrued liabilities |
|
2,171 |
|
|
|
2,411 |
|
|
Deferred rent, current portion |
|
6 |
|
|
|
28 |
|
|
Term loan, current portion |
|
833 |
|
|
|
387 |
|
|
Deferred revenue, current portion |
|
6,524 |
|
|
|
4,989 |
|
|
Total current liabilities |
|
11,524 |
|
|
|
10,298 |
|
|
Deferred rent, net of current portion |
|
322 |
|
|
|
242 |
|
|
Term loan, net of current portion |
|
4,167 |
|
|
|
73 |
|
|
Deferred revenue, net of current portion |
|
18,442 |
|
|
|
21,736 |
|
|
Total liabilities |
|
34,455 |
|
|
|
32,349 |
|
|
Commitments and contingencies (Note 6) |
|
|
|
|
|
|
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 June 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 June 30, 2019 and December 31,
2018, respectively, 0 and 56,828,851 shares issued and outstanding
at June 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 June 30, 2019 and December 31, 2018. No shares
issued and outstanding at June 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 June 30, 2019 and December 31,
2018, respectively, 22,714,765, and 1,374,812 shares issued and
outstanding at June 30, 2019 and December 31, 2018,
respectively |
|
23 |
|
|
|
11 |
|
|
Additional paid-in capital |
|
240,245 |
|
|
|
342 |
|
|
Accumulated deficit |
|
(61,673 |
) |
|
|
(47,297 |
) |
|
Total stockholders’ equity (deficit) |
|
178,595 |
|
|
|
(46,944 |
) |
|
Total liabilities, preferred stock and stockholders’ equity
(deficit) |
$ |
213,050 |
|
|
$ |
147,628 |
|
|
Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
SVP, Corporate Development
(240) 762-6486
IR@nextcure.com
Media Inquiries
Shai Biran, Ph.D.
MacDougall
(781) 235-3060
NextCure@macbiocom.com
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