AnaptysBio Announces First Quarter 2020 Financial Results and Provides Pipeline Updates
May 06 2020 - 3:05PM
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 first quarter ended March 31, 2020 and
provided pipeline updates.
“Our wholly-owned pipeline continues to advance with three Phase
2 clinical trial readouts anticipated in the remainder of 2020,”
said Hamza Suria, president and chief executive officer of
AnaptysBio. “AnaptysBio’s capital-efficient business model has
resulted in the advancement of 7 internally-generated antibodies to
the clinic to date, and we anticipate continued discovery and
development of novel antibodies in the upcoming future. We also
look forward to significant revenues associated with regulatory
filing related milestone payment and future royalties upon FDA
approval of dostarlimab under our GSK partnership later this
year.”
Etokimab (ANB020 Anti-IL-33) Program
- AnaptysBio is conducting a randomized, placebo-controlled Phase
2 trial in 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. We have over-enrolled this trial beyond the first 100
patients to compensate for lost patient visits due to the COVID-19
pandemic, and hence anticipate interim top-line data from this
trial to be available in the third quarter of 2020.
- As previously announced, 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. The Company anticipates
additional clinical data and a regulatory strategy update for the
development of ANB019 in GPP during the second half of 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.
- Enrollment of the GALLOP and POPLAR trials has been enhanced by
expanding clinical sites and geographies involved. While the
Company does not believe that the aforementioned timelines are
materially impacted by the COVID-19 pandemic at this point, some of
the sites involved in the GALLOP and POPLAR trials have been
affected by the COVID-19 pandemic, and the Company will continue to
monitor the situation over the upcoming months.
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. Our Investigational New Drug Application (IND)
for ANB030 has been cleared by the FDA and we plan 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
- In the first quarter of 2020, the FDA accepted the first
Biologics License Application (BLA) filing for dostarlimab, an
AnaptysBio-generated PD-1 antagonist antibody under partnership
with GSK, for the treatment of endometrial cancer. AnaptysBio
received a $10.0 million cash milestone payment upon this
acceptance, and anticipates an additional $20.0 million cash
milestone upon first FDA approval of dostarlimab during 2020. Also
in the first quarter of 2020, the EMA accepted GSK’s Marketing
Authorization Application (MAA) for approval of dostarlimab in the
EU for endometrial cancer, for which AnaptysBio has earned a $5.0
million milestone payment. 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.
First Quarter Financial Results
- Cash, cash equivalents and investments totaled $412.7 million
as of March 31, 2020 compared to $428.5 million as of December 31,
2019, for a decrease of $15.8 million. The decrease relates
primarily to cash used for operating activities.
- Collaboration revenue was $15.0 million for the three months
ended March 31, 2020, which related to milestone payments for
successful BLA and MAA filings for dostarlimab, compared to zero
for the three months ended March 31, 2019.
- Research and development expenses were $21.0 for the three
months ended March 31, 2020, compared to $20.6 million for the
three months ended March 31, 2019. The increase was due primarily
to continued advancement of the Company’s preclinical
programs.
- General and administrative expenses were $4.3 million for the
three months ended March 31, 2020, compared to $4.1 million for the
three months ended March 31, 2019. The increase was due primarily
to personnel-related expenses, including share-based
compensation.
- Net loss was $8.3 million for the three months ended March 31,
2020, or a net loss per share of $0.30, compared to a net loss of
$22.1 million for the three months ended March 31, 2019, or a net
loss per share of $0.82.
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 GSK, 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)
|
March 31, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
165,317 |
|
|
$ |
171,017 |
|
Receivable from collaborative
partners |
5,000 |
|
|
— |
|
Short-term investments |
197,166 |
|
|
203,210 |
|
Prepaid expenses and other
current assets |
3,572 |
|
|
3,506 |
|
Total current assets |
371,055 |
|
|
377,733 |
|
Property and equipment, net |
1,610 |
|
|
1,618 |
|
Long-term investments |
50,215 |
|
|
54,305 |
|
Other long-term assets |
1,293 |
|
|
1,481 |
|
Restricted cash |
60 |
|
|
60 |
|
Total assets |
$ |
424,233 |
|
|
$ |
435,197 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
8,571 |
|
|
$ |
16,237 |
|
Accrued expenses |
13,781 |
|
|
11,052 |
|
Notes payable, current
portion |
— |
|
|
1,375 |
|
Other current liabilities |
898 |
|
|
871 |
|
Total current liabilities |
23,250 |
|
|
29,535 |
|
Other long-term liabilities |
419 |
|
|
654 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value, 10,000 shares authorized and
no shares, issued or outstanding at March 31, 2020 and December 31,
2019, respectively |
— |
|
|
— |
|
Common stock, $0.001 par value, 500,000 shares authorized,
27,277 shares and 27,255 shares issued and outstanding at March 31,
2020 and December 31, 2019, respectively |
27 |
|
|
27 |
|
Additional paid in capital |
651,680 |
|
|
648,669 |
|
Accumulated other comprehensive
income |
1,145 |
|
|
338 |
|
Accumulated deficit |
(252,288 |
) |
|
(244,026 |
) |
Total stockholders’ equity |
400,564 |
|
|
405,008 |
|
Total liabilities and stockholders’ equity |
$ |
424,233 |
|
|
$ |
435,197 |
|
ANAPTYSBIO,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(in thousands, except per share
data)
|
Three Months Ended March 31, |
|
2020 |
|
2019 |
Collaboration revenue |
$ |
15,000 |
|
|
$ |
— |
|
Operating expenses: |
|
|
— |
|
Research and development |
20,968 |
|
|
20,631 |
|
General and administrative |
4,285 |
|
|
4,141 |
|
Total operating expenses |
25,253 |
|
|
24,772 |
|
Loss from operations |
(10,253 |
) |
|
(24,772 |
) |
Other income (expense), net: |
|
|
|
Interest expense |
— |
|
|
(320 |
) |
Interest income |
1,897 |
|
|
2,988 |
|
Other income, net |
94 |
|
|
7 |
|
Total other income (expense), net |
1,991 |
|
|
2,675 |
|
Loss before income taxes |
(8,262 |
) |
|
(22,097 |
) |
Provision for income taxes |
— |
|
|
19 |
|
Net loss |
(8,262 |
) |
|
(22,078 |
) |
Other comprehensive income: |
|
|
|
Unrealized income on available for sale securities, net of tax of
$0 and $115, respectively |
807 |
|
|
427 |
|
Comprehensive loss |
$ |
(7,455 |
) |
|
$ |
(21,651 |
) |
Net loss per common share: |
|
|
|
Basic and diluted |
$ |
(0.30 |
) |
|
$ |
(0.82 |
) |
Weighted-average number of shares outstanding: |
|
|
|
Basic and diluted |
27,264 |
|
|
26,981 |
|
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