AnaptysBio Announces Third Quarter 2019 Financial Results and Provides Pipeline Updates
08 Novembro 2019 - 10:05AM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company developing first-in-class antibody product candidates
focused on unmet medical needs in inflammation, today reported
operating results for the third quarter ended September 30, 2019
and provided pipeline updates.
“While we are disappointed with the top-line results of our
etokimab ATLAS trial, we intend to re-evaluate our etokimab
development strategy following additional data from ATLAS and
top-line results from ECLIPSE in the first quarter of 2020,” said
Hamza Suria, president and chief executive officer of AnaptysBio.
“We look forward to advancing ANB019, ANB030 and additional
preclinical programs in our wholly-owned pipeline.”
Etokimab (ANB020 Anti-IL-33) Program
- The Company today announced topline data from its ATLAS trial,
a Phase 2b randomized, double-blinded, placebo-controlled,
multi-dose study in approximately 300 adult patients treated with
etokimab in moderate-to-severe atopic dermatitis. Each of the
etokimab dosing arms failed to meet the primary endpoint of the
trial, which was demonstration of statistically greater improvement
in the Eczema Area and Severity Index (EASI) relative placebo at
week 16.
- AnaptysBio is conducting a randomized, placebo-controlled Phase
2 trial in approximately 100 adult patients with chronic
rhinosinusitis with nasal polyps, also referred to as the ECLIPSE
trial. Patients are being treated with two multi-dosing frequencies
of subcutaneously-administered etokimab or placebo, each in
combination with mometasone furoate nasal spray as background
therapy. The Company anticipates topline data from an interim
analysis of the ECLIPSE trial in the first quarter of 2020.
- The Company has decided to postpone the initiation of its
planned Phase 2b etokimab clinical trial in eosinophilic asthma, a
multi-dose, randomized, double-blinded, placebo-controlled trial in
300-400 patients, until it has the opportunity to analyze the full
data set from the ATLAS trial.
ANB019 (Anti-IL-36 Receptor) Program
- In September, AnaptysBio announced positive topline data from
an interim analysis of its Phase 2 clinical trial of ANB019
monotherapy in moderate-to-severe generalized pustular psoriasis,
or GPP, also known as the GALLOP trial. In this interim
analysis, both patients achieved the primary endpoint of disease
score improvement at Day 29 and Day 113 without requiring rescue
therapy, demonstrated rapid and sustained mJDA score improvement,
with reduction of 58% at Day 8 and 63% at Day 113, and showed
complete clearance of skin pustules by Day 8 and through Day 113,
with CRP levels decreasing to nearly normal. Enrollment is
ongoing in the GALLOP study, and the Company anticipates additional
clinical data and a regulatory strategy update for the development
of ANB019 in GPP during 2020.
- The Company is also conducting a randomized,
placebo-controlled, multi-dose Phase 2 trial in 50 patients with
palmoplantar pustulosis, or PPP, also known as the POPLAR trial,
with topline data anticipated in the first half of 2020.
ANB030 (Anti-PD-1 Agonist) Program
- ANB030 is a wholly-owned antibody that binds PD-1 in an
agonistic manner, leading to reduced T cell activity and
anti-inflammatory effects in vivo. Genetic mutations in the
PD-1 pathway are associated with increased susceptibility to
various inflammatory conditions and we believe ANB030 has the
potential to suppress inflammatory diseases by restoring
insufficient PD-1-mediated negative signaling on activated T cells.
The Company plans to focus future clinical development of ANB030 on
certain autoimmune diseases where PD-1 checkpoint receptor function
may be under-represented and anticipates filing an Investigational
New Drug Application (IND) in the fourth quarter of 2019 and
initiating a Phase 1 clinical trial in 2020. Preclinical data from
the ANB030 was presented in June at the 2019 FOCIS Annual
Meeting.
Board of Directors
- In September, the Company appointed Laura J. Hamill to its
board of directors. Most recently, Ms. Hamill served as
Executive Vice President, Worldwide Commercial Operations, for
Gilead Sciences, where she was involved in the strategic direction
and long-term planning of the organization. Previously, Ms. Hamill
held a number of US and international executive roles at Amgen,
culminating with Senior Vice President and General Manager where
she led ~$20B in U.S. commercial operations.
Third Quarter Financial Results
- Cash, cash equivalents and investments totaled $444.4 million
as of September 30, 2019 compared to $500.2 million as of
December 31, 2018, for a decrease of $55.8 million. The
decrease relates primarily to cash used for operating
activities.
- Collaboration revenue was zero and $5.0 million for the three
and nine months ended September 30, 2019, which related to a
milestone for initiation of a Phase 3 trial in a second indication
for dostarlimab, the anti-PD-1 antagonist antibody partnered with
TESARO, a GlaxoSmithKline (GSK) company, compared to $5.0 million
for the three and nine months ended September 30, 2018.
- Research and development expenses were $29.9 million and $77.9
million for the three and nine months ended September 30, 2019,
compared to $17.9 million and $40.3 million for the three and nine
months ended September 30, 2018. The increase was due primarily to
continued advancement of the Company’s etokimab and ANB019 clinical
programs and additional personnel-related expenses, including
share-based compensation.
- General and administrative expenses were $3.8 million and $12.3
million for the three and nine months ended September 30, 2019,
compared to $4.0 million and $11.8 million for the three and nine
months ended September 30, 2018. The change was due primarily to
personnel-related expenses, including share-based
compensation.
- Net loss was $31.0 million and $77.1 million for the three and
nine months ended September 30, 2019, or a net loss per share of
$1.15 and $2.85, compared to a net loss of $16.0 million and $44.7
million for the three and nine months ended September 30,
2018, or a net loss per share of $0.66 and $1.86.
Financial Guidance
AnaptysBio expects that its cash, cash equivalents and
investments will fund its current operating plan, taking into
account the adjustments to etokimab clinical development activities
referenced above, at least into 2021. The Company
expects to re-evaluate its current operating plan in light of the
topline data from the ATLAS trial and to make adjustments as
appropriate to manage the Company’s available cash resources.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing
first-in-class antibody product candidates focused on unmet medical
needs in inflammation. The Company’s proprietary anti-inflammatory
pipeline includes its anti-IL-33 antibody etokimab, previously
referred to as ANB020, for the treatment of moderate-to-severe
atopic dermatitis, eosinophilic asthma, and adult chronic
rhinosinusitis with nasal polyps, or CRSwNP; its anti-IL-36R
antibody ANB019 for the treatment of rare inflammatory diseases,
including generalized pustular psoriasis, or GPP, and palmoplantar
pustulosis, or PPP; and its PD-1 agonist program, ANB030, and other
novel anti-inflammatory checkpoint receptor modulator antibodies
for treatment of certain autoimmune diseases where immune
checkpoint receptors are insufficiently activated. AnaptysBio’s
antibody pipeline has been developed using its proprietary somatic
hypermutation, or SHM platform, which uses in vitro SHM for
antibody discovery and is designed to replicate key features of the
human immune system to overcome the limitations of competing
antibody discovery technologies. AnaptysBio has also developed
multiple therapeutic antibodies in an immuno-oncology partnership
with TESARO, a GSK company, including an anti-PD-1 antagonist
antibody (dostarlimab (TSR-042)), an anti-TIM-3 antagonist antibody
(TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), and an
inflammation partnership with Celgene, including an anti-PD-1
checkpoint agonist antibody (CC-90006) currently in clinical
development.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, including, but not
limited to: the timing of the release of data from our clinical
trials, including etokimab’s Phase 2 clinical trial in adult
patients with chronic rhinosinusitis with nasal polys and ANB019’s
Phase 2 clinical trials in GPP and PPP, the timing of and our
ability to launch a Phase 2b clinical trial of etokimab in
eosinophilic asthma patients, the timing of a regulatory strategy
update for GPP, and the timing of an IND filing and initiation of a
Phase 1 clinical trial for ANB030, a new wholly-owned
anti-inflammatory antibody program. Statements including words such
as “plan,” “continue,” “expect,” or “ongoing” and statements in the
future tense are forward-looking statements. These forward-looking
statements involve risks and uncertainties, as well as assumptions,
which, if they do not fully materialize or prove incorrect, could
cause our results to differ materially from those expressed or
implied by such forward-looking statements. Forward-looking
statements are subject to risks and uncertainties that may cause
the company’s actual activities or results to differ significantly
from those expressed in any forward-looking statement, including
risks and uncertainties related to the company’s ability to advance
its product candidates, obtain regulatory approval of and
ultimately commercialize its product candidates, the timing and
results of preclinical and clinical trials, the company’s ability
to fund development activities and achieve development goals, the
company’s ability to protect intellectual property and other risks
and uncertainties described under the heading “Risk Factors” in
documents the company files from time to time with the Securities
and Exchange Commission. These forward-looking statements speak
only as of the date of this press release, and the company
undertakes no obligation to revise or update any forward-looking
statements to reflect events or circumstances after the date
hereof.
Contact:Eric LoumeauAnaptysBio,
Inc.858.732.0179eloumeau@anaptysbio.com
ANAPTYSBIO, INC. |
CONSOLIDATED BALANCE SHEETS |
(in thousands, except par value data) |
|
|
|
September 30, 2019 |
|
December 31, 2018 |
|
|
(unaudited) |
|
|
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
182,898 |
|
|
$ |
113,596 |
|
Australian tax incentive receivable |
— |
|
|
174 |
|
Short-term investments |
238,104 |
|
|
313,486 |
|
Prepaid expenses and other current assets |
3,595 |
|
|
6,960 |
|
Total current assets |
424,597 |
|
|
434,216 |
|
Property and equipment, net |
1,695 |
|
|
1,445 |
|
Long-term investments |
23,418 |
|
|
73,128 |
|
Other long-term assets |
1,735 |
|
|
148 |
|
Restricted cash |
60 |
|
|
60 |
|
Total assets |
$ |
451,505 |
|
|
$ |
508,997 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
10,522 |
|
|
$ |
5,443 |
|
Accrued expenses |
15,286 |
|
|
8,761 |
|
Notes payable, current portion |
3,077 |
|
|
7,574 |
|
Other current liabilities |
845 |
|
|
58 |
|
Total current liabilities |
29,730 |
|
|
21,836 |
|
Other long-term liabilities |
883 |
|
|
796 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value, 10,000 shares
authorized and no shares, issued or outstanding at September 30,
2019 and December 31, 2018, respectively |
— |
|
|
— |
|
Common stock, $0.001 par value, 500,000 shares
authorized, 27,098 shares and 26,922 shares issued and outstanding
at September 30, 2019 and December 31, 2018, respectively |
27 |
|
|
27 |
|
Additional paid in capital |
644,148 |
|
|
633,251 |
|
Accumulated other comprehensive income (loss) |
480 |
|
|
(223 |
) |
Accumulated deficit |
(223,763 |
) |
|
(146,690 |
) |
Total stockholders’ equity |
420,892 |
|
|
486,365 |
|
Total liabilities and stockholders’ equity |
$ |
451,505 |
|
|
$ |
508,997 |
|
ANAPTYSBIO, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(in thousands, except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
Collaboration revenue |
$ |
— |
|
|
$ |
5,000 |
|
|
$ |
5,000 |
|
|
$ |
5,000 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
29,931 |
|
|
17,883 |
|
|
77,912 |
|
|
40,276 |
|
|
General and administrative |
3,814 |
|
|
4,004 |
|
|
12,262 |
|
|
11,783 |
|
|
Total operating expenses |
33,745 |
|
|
21,887 |
|
|
90,174 |
|
|
52,059 |
|
|
Loss from operations |
(33,745 |
) |
|
(16,887 |
) |
|
(85,174 |
) |
|
(47,059 |
) |
|
Other income (expense), net: |
|
|
|
|
|
|
|
|
Interest expense |
(240 |
) |
|
(400 |
) |
|
(841 |
) |
|
(1,287 |
) |
|
Interest income |
2,757 |
|
|
1,369 |
|
|
8,702 |
|
|
3,851 |
|
|
Other income (expense), net |
144 |
|
|
(40 |
) |
|
110 |
|
|
(167 |
) |
|
Total other income (expense), net |
2,661 |
|
|
929 |
|
|
7,971 |
|
|
2,397 |
|
|
Loss before income taxes |
(31,084 |
) |
|
(15,958 |
) |
|
(77,203 |
) |
|
(44,662 |
) |
|
Provision for income taxes |
51 |
|
|
— |
|
|
130 |
|
|
— |
|
|
Net loss |
(31,033 |
) |
|
(15,958 |
) |
|
(77,073 |
) |
|
(44,662 |
) |
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Unrealized (loss) income on available for sale securities, net of
tax of ($25), $0, $189 and $0, respectively |
(94 |
) |
|
136 |
|
|
703 |
|
|
(115 |
) |
|
Comprehensive loss |
$ |
(31,127 |
) |
|
$ |
(15,822 |
) |
|
$ |
(76,370 |
) |
|
$ |
(44,777 |
) |
|
Net loss per common share: |
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(1.15 |
) |
|
$ |
(0.66 |
) |
|
$ |
(2.85 |
) |
|
$ |
(1.86 |
) |
|
Weighted-average number of shares outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
27,058 |
|
|
24,146 |
|
|
27,022 |
|
|
23,961 |
|
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