Apellis Pharmaceuticals Reports Second Quarter 2018 Business Update and Financial Results
July 31 2018 - 4:30PM
- Commenced Phase 3 Trial of APL-2 in Paroxysmal
Nocturnal Hemoglobinuria (PNH); APL-2 in Geographic Atrophy (GA)
Remains On Track to Advance into Phase 3 in 2H18 -
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a clinical-stage
biopharmaceutical company focused on the development of novel
therapeutic compounds to treat disease through the inhibition of
the complement system, today announced its second quarter 2018
financial results and business highlights.
“The second quarter of 2018 was marked by significant clinical
progress of APL-2, particularly for the potential treatment of
PNH,” said Cedric Francois, MD, PhD, founder and chief executive
officer of Apellis. “At our R&D Day, we announced the earlier
than anticipated enrollment of the first patient in the Phase 3
PEGASUS trial of APL-2 head-to-head with Soliris, and additional
patient data from the ongoing PADDOCK and PHAROAH Phase 1b trials
of APL-2 in patients with PNH. We also reported initial data from
the Phase 2 proof-of-concept (POC) monotherapy trial of APL-2 in
autoimmune hemolytic anemia (AIHA). In the second half of 2018, we
plan to continue to push forward with the enrollment of our ongoing
Phase 3 trial of APL-2 in PNH, to commence our Phase 3 program of
APL-2 in GA, and to present additional data from the Phase 2 POC
trial of APL-2 in AIHA and initial data from the Phase 2 POC trial
in complement-dependent nephropathies.”
Business Highlights and Upcoming
Milestones:
APL-2 in Geographic Atrophy
- The Phase 3 program consisting of two trials of APL-2 in GA
remains on track to begin in the second half of 2018.
APL-2 in PNH
- Enrolled the first patient in the PEGASUS Phase 3 trial of
APL-2 in PNH in June 2018.
- Provided clinical update from the ongoing Phase 1b PHAROAH
trial evaluating APL-2 in PNH in June 2018. The PHAROAH trial
interim results showed that for the four patients remaining in the
study as of the end of June, no transfusions were needed while
receiving co-treatment with Soliris and APL-2, and patients
maintained hematological benefits following Soliris dose reductions
and weaning.
- Provided clinical update from the ongoing Phase 1b PADDOCK
trial evaluating APL-2 in PNH in June 2018 and April 2018. The
PADDOCK trial interim results showed that the 13 patients on APL-2
that had not previously been treated with Soliris had improved
hemoglobin, bilirubin, reticulocyte and LDH levels on average.
APL-2 In Other Indications
- Reported initial data from the Phase 2 POC trial of APL-2 in
AIHA in June 2018.
- The data from the Phase 2 POC monotherapy trial of APL-2 in
four types of complement-dependent nephropathies (IgA nephropathy,
C3 glomerulonephropathy, primary membranous nephropathy and lupus
nephritis) are expected in the second half of 2018.
Corporate Highlights
- Completed a public offering of 5.5 million shares of common
stock at $25.50 per share in April 2018, raising net proceeds of
$131.3 million, after deducting underwriting discounts, commissions
and offering expenses.
- Strengthened the Company’s senior management team with the
appointment of Lukas Scheibler, PhD, as Executive Vice President,
Research and Translational Medicine in April 2018. Dr. Scheibler
was most recently the head of R&D at Acucela and previously
worked at Novartis for 13 years, focused on research &
development, business development and clinical development.
- Hosted the Company’s first R&D Day in June 2018, which
included detailed presentations on APL-2 in GA, PNH, AIHA and CDN,
as well as key opinion leader presentations and patient commentary
on GA and PNH.
Second Quarter 2018 Financial Results:
As of June 30, 2018, Apellis had $253.8 million in cash and cash
equivalents, compared to $152.9 million as of March 31, 2018. This
includes $131.3 million in net proceeds raised in a public offering
of 5.5 million shares of common stock at $25.50 per share in April
2018.
Apellis reported a net loss of $33.3 million for the second
quarter of 2018, compared to a net loss of $12.1 million for the
second quarter of 2017.
Research and development expenses were $27.5 million in the
second quarter of 2018, compared to $10.4 million for the same
period in 2017. The increase was primarily due to an increase of
$12.1 million in clinical trial costs, an increase of $2.4 million
in employee related costs primarily due to the hiring of additional
personnel, an increase of $1.9 million in manufacturing expenses,
an increase of $0.8 million related to research and development
supporting activities and an increase of $0.2 million in
pre-clinical study expenses, offset by a decrease of $0.3 million
in device development expenses.
General and administrative expenses were $5.9 million in the
second quarter of 2018, compared to $1.7 million in the second
quarter of 2017. The increase was primarily due to a an increase in
employee related costs of $1.6 million, an increase of $0.4 million
in director stock option compensation, an increase in office,
travel and related costs of $0.5 million, an increase in
professional and consulting fees of $1.1 million, an increase in
license agreement costs of $0.4 million, and an increase of $0.2
million in insurance costs.
About the PHAROAH Trial PHAROAH is an ongoing
open label Phase 1b safety and efficacy study of 270 mg of APL-2
administered daily by subcutaneous injection as a complementary
therapy to patients with PNH who continue to be anemic (Hb <10
g/dL at screening or have a history of at least one transfusion in
the previous year) despite treatment with eculizumab. The PHAROAH
study was initiated in November 2014 and is being conducted at
multiple clinical sites in the United States.
About the PADDOCK Trial PADDOCK is an ongoing
open-label Phase 1b safety and efficacy study of 270 mg of APL-2
administered daily by subcutaneous injection to patients with PNH
who have never received eculizumab. The PADDOCK study was initiated
in December 2015 and is being conducted at multiple clinical sites
outside of the United States.
About ApellisApellis Pharmaceuticals, Inc. is a
clinical-stage biopharmaceutical company focused on the development
of novel therapeutic compounds for the treatment of a broad range
of life-threatening or debilitating autoimmune diseases based upon
complement immunotherapy through the inhibition of the complement
system at the level of C3. Apellis is the first company to advance
chronic therapy with a C3 inhibitor into clinical trials. For
additional information about Apellis and APL-2, please visit
http://www.apellis.com.
Forward-Looking Statements Statements in this
press release about future expectations, plans and prospects,
as well as any other statements regarding matters that are not
historical facts, may constitute “forward-looking statements”
within the meaning of The Private Securities Litigation Reform Act
of 1995. These statements include, but are not limited to,
statements relating to the implications of preliminary clinical
data. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “will,” “would” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including: whether results obtained in
preclinical studies and clinical trials, such as the results
referenced in this release, will be indicative of results that will
be generated in future clinical trials; whether preliminary or
interim results from a clinical trial will be predictive of the
final results of the trial; whether APL-2 will successfully advance
through the clinical trial process on a timely basis, or at all;
whether the results of such clinical trials will warrant regulatory
submission; whether APL-2 will receive approval from
the United States Food and Drug Administration or
equivalent foreign regulatory agencies; whether, if Apellis’
products receive approval, they will be successfully distributed
and marketed; whether Apellis’ cash resources will be sufficient to
fund the company's foreseeable and unforeseeable operating expenses
and capital expenditure requirements; and other factors discussed
in the “Risk Factors” section of Apellis’ Quarterly Report on Form
10-Q filed with the Securities and Exchange
Commission on July 31, 2018, and the risks described in
other filings that Apellis may make with the Securities and
Exchange Commission. Any forward-looking statements contained in
this press release speak only as of the date hereof,
and Apellis specifically disclaims any obligation to
update any forward-looking statement, whether as a result of new
information, future events or otherwise.
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APELLIS PHARMACEUTICALS,
INC. |
|
|
CONSOLIDATED BALANCE SHEETS |
|
|
(Unaudited) |
|
|
|
|
|
December 31, |
|
June 30, |
|
|
|
|
2017 |
|
|
|
2018 |
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
|
$ |
175,643,529 |
|
|
$ |
253,839,540 |
|
Refundable research and development credit |
|
|
|
1,297,361 |
|
|
|
1,996,996 |
|
Prepaid
assets |
|
|
|
5,059,593 |
|
|
|
10,857,287 |
|
Other
current assets |
|
|
|
14,823 |
|
|
|
7,695 |
|
Total current assets |
|
|
|
182,015,306 |
|
|
|
266,701,518 |
|
Other
assets |
|
|
|
116,150 |
|
|
|
116,150 |
|
Total
assets |
|
|
$ |
182,131,456 |
|
|
$ |
266,817,668 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
|
|
$ |
3,663,253 |
|
|
$ |
5,133,017 |
|
Accrued
expenses |
|
|
|
2,890,705 |
|
|
|
5,121,178 |
|
Total current liabilities |
|
|
|
6,553,958 |
|
|
|
10,254,195 |
|
Long-term liabilities: |
|
|
|
|
|
Term loan
facility |
|
|
|
19,806,944 |
|
|
|
20,143,217 |
|
Promissory note - related party |
|
|
|
6,583,402 |
|
|
|
6,618,150 |
|
Common
stock warrant liability |
|
|
|
244,292 |
|
|
|
250,000 |
|
Total
liabilities |
|
|
|
33,188,596 |
|
|
|
37,265,562 |
|
Stockholders' equity: |
|
|
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares
authorized, and zero shares issued and
outstanding at December 31, 2017 and June 30, 2018 |
|
|
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value; 200,000,000 shares
authorized at December 31, 2017 and June 30, 2018 and
50,334,152 shares issued and outstanding at December 31,
2017 and 56,154,438 shares issued and outstanding at June 30,
2018 |
|
|
|
5,033 |
|
|
|
5,615 |
|
Additional paid in capital |
|
|
|
298,201,480 |
|
|
|
433,880,750 |
|
Accumulated deficit |
|
|
|
(149,263,653 |
) |
|
|
(204,334,259 |
) |
Total stockholders' equity |
|
|
|
148,942,860 |
|
|
|
229,552,106 |
|
Total
liabilities and stockholders' equity |
|
|
$ |
182,131,456 |
|
|
$ |
266,817,668 |
|
|
|
|
|
|
|
APELLIS PHARMACEUTICALS,
INC. |
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research
and development |
$ |
10,422,059 |
|
|
$ |
27,537,619 |
|
|
$ |
17,653,143 |
|
|
$ |
44,940,509 |
|
General
and administrative |
|
1,710,344 |
|
|
|
5,947,823 |
|
|
|
3,531,753 |
|
|
|
9,983,079 |
|
Operating loss |
|
(12,132,403 |
) |
|
|
(33,485,442 |
) |
|
|
(21,184,896 |
) |
|
|
(54,923,588 |
) |
Interest
income (expense), net |
|
5,854 |
|
|
|
184,009 |
|
|
|
15,966 |
|
|
|
(82,677 |
) |
Other
income (expense), net |
|
397 |
|
|
|
(32,867 |
) |
|
|
(7,995 |
) |
|
|
(64,341 |
) |
Net loss
and comprehensive loss |
$ |
(12,126,152 |
) |
|
$ |
(33,334,300 |
) |
|
$ |
(21,176,925 |
) |
|
$ |
(55,070,606 |
) |
Net loss
per common share, basic and diluted |
$ |
(1.44 |
) |
|
$ |
(0.61 |
) |
|
$ |
(2.51 |
) |
|
$ |
(1.05 |
) |
Weighted-average number of common shares used in net |
|
|
|
|
|
|
|
loss per
common share, basic and diluted |
|
8,428,366 |
|
|
|
54,691,833 |
|
|
|
8,428,366 |
|
|
|
52,534,806 |
|
|
|
|
|
|
|
|
|
Investor Contact:
Alex Kane
akane@w2ogroup.com
212.301.7218 (office)
929.400.2691 (mobile)
Media Contact:
Tully Nicholas
tnicholas@denterlein.com
617.482.0042 (office)
860.490.0218 (mobile)
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