AnaptysBio Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Pipeline Updates
03 March 2020 - 12:45AM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company developing first-in-class antibody product candidates
focused on emerging immune control mechanisms applicable to
inflammation and immuno-oncology indications, today reported
operating results for the fourth quarter and year ended December
31, 2019 and provided pipeline updates.
“We look forward to three Phase 2 clinical trial
readouts from our wholly-owned etokimab and ANB019 programs and the
expansion of our pipeline with ANB030 and ANB032 during 2020,” said
Hamza Suria, president and chief executive officer of AnaptysBio.
“AnaptysBio is a capital-efficient antibody discovery and
development engine that has been validated by the advancement of 7
internally-generated therapeutics to the clinic over the last 4
years, and we look forward to anticipated FDA approval of
dostarlimab under our GSK partnership.”
Etokimab (ANB020 Anti-IL-33) Program
- 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
half of 2020.
- The Company previously announced
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 has
discontinued development of etokimab in moderate-to-severe atopic
dermatitis.
- 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 results are
available from the ECLIPSE 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 second half of
2020.
- AnaptysBio has taken steps to
enhance enrollment in the GALLOP and POPLAR trials, including
expansion of clinical trial sites and countries.
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, submitted an Investigational New Drug
Application (IND) in the fourth quarter of 2019 and plans to
initiate a Phase 1 clinical trial in the first half of 2020.
Preclinical data from the ANB030 was presented in June at the 2019
FOCIS Annual Meeting.
ANB032 (Anti-BTLA Modulator) Program
- Our fourth wholly-owned program is
an anti-BTLA modulator antibody, known as ANB032, which is broadly
applicable to human inflammatory diseases associated with lymphoid
and myeloid immune cell dysregulation. Mutations in the BTLA
signaling pathway are associated with human inflammatory disease
and we believe ANB032 silences pro-inflammatory signaling by
modulating BTLA binding to HVEM. We anticipate filing an IND
for ANB032 in the second half of 2020.
Dostarlimab (Anti-PD-1 Antagonist) Program
Partnered with GSK
- GSK has recently announced that a
first BLA filing for dostarlimab, an AnaptysBio-generated PD-1
antagonist antibody under partnership with TESARO, a GSK company,
occurred in the fourth quarter of 2019 for the treatment of
endometrial cancer. AnaptysBio anticipates receiving a $10.0
million cash milestone payment upon acceptance of this BLA filing
and a $20.0 million cash milestone upon first FDA approval of
dostarlimab. Including additional cash milestones due upon future
development and commercialization of dostarlimab, TSR-022, an
AnaptysBio-generated TIM-3 antibody, and TSR-033, an
AnaptysBio-generated LAG-3 antibody, AnaptysBio can potentially
receive a total of $1.1 billion in aggregate milestone payments
under this GSK partnership. In addition, AnaptysBio is due a 4% to
8% royalty from GSK, tiered upon global sales, for each of the
aforementioned programs.
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.
Fourth Quarter and Full Year Financial
Results
- Cash, cash equivalents and investments totaled $428.5 million
as of December 31, 2019 compared to $500.2 million as of December
31, 2018, for a decrease of $71.7 million. The decrease relates
primarily to cash used for operating activities.
- Collaboration revenue was $3.0 million and $8.0 million for the
three months and year ended December 31, 2019, which related to a
milestone for initiation of a Phase 2 trial for TSR-033, the
anti-LAG-3 antibody partnered with TESARO, a GlaxoSmithKline (GSK)
company, compared to zero and $5.0 million for the three and year
ended December 31, 2018.
- Research and development expenses were $21.4 million and $99.3
million for the three months and year ended December 31, 2019,
compared to $15.9 million and $56.2 million for the three months
and year ended December 31, 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 $16.1
million for the three months and year ended December 31, 2019,
compared to $3.7 million and $15.5 million for the three months and
year ended December 31, 2018. The increase was due primarily
to personnel-related expenses, including share-based
compensation.
- Net loss was $20.3 million and $97.3 million for the three
months and year ended December 31, 2019, or a net loss per share of
$0.75 and $3.60, compared to a net loss of $17.0 million and $61.7
million for the three months and year ended December 31, 2018,
or a net loss per share of $0.64 and $2.50.
Financial Guidance
AnaptysBio expects its net cash burn in 2020
will be approximately $60.0 million, and that its cash, cash
equivalents and investments will fund its current operating
plan at least into 2023.
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 chronic rhinosinusitis with nasal polyps, or CRSwNP,
and eosinophilic asthma; its anti-IL-36R antibody ANB019 for the
treatment of rare inflammatory diseases, including generalized
pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP;
its anti-PD-1 agonist program, ANB030, for treatment of certain
autoimmune diseases where immune checkpoint receptors are
insufficiently activated, and its BTLA modulator program, ANB032,
which is broadly applicable to human inflammatory diseases
associated with lymphoid and myeloid immune cell dysregulation.
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 CRSwNP 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, the timing of
initiation of a Phase 1 clinical trial for ANB030, the timing of an
IND filing for ANB032, the milestones and royalty payments to be
received under the GSK partnership, and our projected 2020 cash
burn and cash runway. 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) |
|
|
December 31, 2019 |
|
December 31, 2018 |
|
|
|
|
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
171,017 |
|
|
$ |
113,596 |
|
Australian tax incentive
receivable |
— |
|
|
174 |
|
Short-term investments |
203,210 |
|
|
313,486 |
|
Prepaid expenses and other
current assets |
3,506 |
|
|
6,960 |
|
Total current assets |
377,733 |
|
|
434,216 |
|
Property and equipment, net |
1,618 |
|
|
1,445 |
|
Long-term investments |
54,305 |
|
|
73,128 |
|
Other long-term assets |
1,481 |
|
|
148 |
|
Restricted cash |
60 |
|
|
60 |
|
Total assets |
$ |
435,197 |
|
|
$ |
508,997 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
16,237 |
|
|
$ |
5,443 |
|
Accrued expenses |
11,052 |
|
|
8,761 |
|
Notes payable, current
portion |
1,375 |
|
|
7,574 |
|
Other current liabilities |
871 |
|
|
58 |
|
Total current liabilities |
29,535 |
|
|
21,836 |
|
Other long-term liabilities |
654 |
|
|
796 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value, 10,000 shares authorized and
no shares, issued or outstanding at December 31, 2019 and December
31, 2018, respectively |
— |
|
|
— |
|
Common stock, $0.001 par value, 500,000 shares authorized,
27,255 shares and 26,922 shares issued and outstanding at December
31, 2019 and December 31, 2018, respectively |
27 |
|
|
27 |
|
Additional paid in capital |
648,669 |
|
|
633,251 |
|
Accumulated other comprehensive
income (loss) |
338 |
|
|
(223 |
) |
Accumulated deficit |
(244,026 |
) |
|
(146,690 |
) |
Total stockholders’ equity |
405,008 |
|
|
486,365 |
|
Total liabilities, preferred stock and stockholders’ equity |
$ |
435,197 |
|
|
$ |
508,997 |
|
ANAPTYSBIO, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(in thousands, except per share data) |
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Collaboration revenue |
$ |
3,000 |
|
|
$ |
— |
|
|
$ |
8,000 |
|
|
$ |
5,000 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
21,426 |
|
|
15,920 |
|
|
99,338 |
|
|
56,196 |
|
General and administrative |
3,832 |
|
|
3,743 |
|
|
16,094 |
|
|
15,526 |
|
Total operating expenses |
25,258 |
|
|
19,663 |
|
|
115,432 |
|
|
71,722 |
|
Loss from operations |
(22,258 |
) |
|
(19,663 |
) |
|
(107,432 |
) |
|
(66,722 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
Interest expense |
(200 |
) |
|
(365 |
) |
|
(1,041 |
) |
|
(1,652 |
) |
Interest income |
2,282 |
|
|
2,834 |
|
|
10,984 |
|
|
6,685 |
|
Other (expense) income, net |
(109 |
) |
|
8 |
|
|
1 |
|
|
(159 |
) |
Total other income (expense), net |
1,973 |
|
|
2,477 |
|
|
9,944 |
|
|
4,874 |
|
Loss before income taxes |
(20,285 |
) |
|
(17,186 |
) |
|
(97,488 |
) |
|
(61,848 |
) |
Provision for income taxes |
22 |
|
|
192 |
|
|
152 |
|
|
192 |
|
Net loss |
(20,263 |
) |
|
(16,994 |
) |
|
(97,336 |
) |
|
(61,656 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
Unrealized income (loss) on available for sale securities, net of
tax of ($36), $55, $153, and $55, respectively |
(142 |
) |
|
318 |
|
|
561 |
|
|
203 |
|
Comprehensive loss |
$ |
(20,405 |
) |
|
$ |
(16,676 |
) |
|
$ |
(96,775 |
) |
|
$ |
(61,453 |
) |
Net loss per common share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.75 |
) |
|
$ |
(0.64 |
) |
|
$ |
(3.60 |
) |
|
$ |
(2.50 |
) |
Weighted-average number of shares
outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
27,154 |
|
|
26,788 |
|
|
27,059 |
|
|
24,673 |
|
AnaptysBio (NASDAQ:ANAB)
Historical Stock Chart
From Jun 2024 to Jul 2024
AnaptysBio (NASDAQ:ANAB)
Historical Stock Chart
From Jul 2023 to Jul 2024