AnaptysBio Announces Third Quarter 2018 Financial Results and Provides Pipeline Updates
November 08 2018 - 4:15PM
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, 2018
and provided pipeline updates.
“We continued to advance the clinical development of our
wholly-owned etokimab and ANB019 programs for severe inflammatory
disease indications during the third quarter of 2018,”
said Hamza Suria, president and chief executive officer of
AnaptysBio. “Top-line data from our etokimab Phase 2a trial in
severe adult eosinophilic asthma patients demonstrated rapid and
sustained improvement in Forced Exhaled Volume In One Second versus
placebo, with corresponding reduction in blood eosinophil levels.
We look forward to further advancement of our wholly-owned pipeline
with four additional readouts from ongoing clinical trials of
etokimab and ANB019 during 2019.”
Etokimab (ANB020 Anti-IL-33 Program)
- In September, the Company announced positive topline
proof-of-concept data for etokimab, its investigational anti-IL-33
therapeutic antibody, in an ongoing single dose Phase 2a clinical
trial in adult patients with severe eosinophilic asthma. Patients
administered with etokimab rapidly improved their Forced Exhaled
Volume In One Second, or FEV1, which is a measure of lung function,
with an eight percent FEV1 improvement over placebo at Day 2. FEV1
improvement was sustained through Day 64, with an 11 percent
increase over placebo. Blood eosinophil reduction was sustained
through the interim analysis period, with a 31 percent reduction at
Day 2 and a 46 percent reduction at Day 64 over placebo, which was
consistent with FEV1 improvement observed in this trial. Etokimab
was generally well tolerated in all patients and no serious adverse
events were reported as of this interim analysis. This Phase 2a
trial is currently ongoing and the company plans to report full
data from this trial at a medical conference in 2019 following
trial completion. AnaptysBio plans to continue development of
etokimab in eosinophilic asthma with a multi-dose Phase 2b
randomized, double-blinded, placebo-controlled trial, which is
expected to be initiated in 2019.
- The Company is enrolling a Phase 2b randomized, double-blinded,
placebo-controlled, multi-dose study in 300 adult
patients with moderate-to-severe atopic dermatitis, also
referred to as the ATLAS clinical trial, to assess different dose
levels and dosing frequencies of subcutaneously-administered
etokimab for a 16-week treatment period followed by an eight-week
monitoring period, with data expected in the second half of
2019.
- The Company has cleared an IND and initiated a randomized,
placebo-controlled Phase 2 trial, also referred to as the ECLIPSE
trial, in approximately 100 adult patients with chronic
rhinosinusitis with nasal polyps. Patients will be treated with two
multi-dosing frequencies of subcutaneous-administered etokimab or
placebo, each in combination with mometasone furoate nasal spray as
background therapy, for a treatment period of 16 weeks followed by
an eight-week monitoring period. The Company anticipates top-line
data from the ECLIPSE trial will be available in the second half of
2019.
ANB019 (Anti-IL-36 Receptor Program)
- AnaptysBio has initiated a 10-patient, single arm, open-label
Phase 2 trial of ANB019 in generalized pustular psoriasis, or GPP,
also known as the GALLOP trial, and top-line data are anticipated
in mid-2019. All patients will be treated with an intravenous
loading dose of ANB019 upon enrollment, followed by
subcutaneously-administered monthly doses of ANB019 for a treatment
period of up to 16 weeks post enrollment and followed by an
eight-week monitoring period.
- AnaptysBio has cleared an IND with the FDA and has initiated a
randomized, placebo-controlled 50-patient multi-dose Phase 2 trial
in palmoplantar pustulosis, or PPP, also known as the POPLAR trial,
where top line data are anticipated in the second half of 2019.
Patients will be treated with a (i) a subcutaneously-administered
loading dose of ANB019 upon enrollment, followed by
subcutaneously-administered monthly doses of ANB019, or (ii)
placebo, each for a treatment period of 16 weeks post enrollment
and followed an eight-week monitoring period.
Corporate Highlights
- On September 28, 2018, the Company completed an
underwritten public offering of 2,530,000 shares of common stock at
a price to the public of $94.46, which included the exercise by the
underwriters of their option to purchase an additional 330,000
shares of common stock. AnaptysBio, received net proceeds from the
offering of $227.5 million, after deducting underwriting
discounts and commissions.
Third Quarter Financial Results
- Cash, cash equivalents and investments totaled $512.4 million
as of September 30, 2018 compared to $324.3 million as of
December 31, 2017, for an increase of $188.1 million. The increase
primarily relates to net proceeds received by the Company of $227.5
million from the public offering, offset by operating cash outflow
for clinical and manufacturing related expenses, as well as
personnel costs.
- Collaboration revenue was $5.0 million for the three and nine
months ended September 30, 2018 related to a milestone
for the first Phase 3 trial of TSR-042 by TESARO compared to
no revenue and $7.0 million for two TESARO milestones for the three
and nine months ended September 30, 2017, respectively.
- Research and development expenses were $17.9 million for the
three months ended September 30, 2018, as compared to $6.7 million
for the three months ended September 30, 2017. The increase was
primarily due to continued advancement of the Company’s etokimab
and ANB019 clinical programs and additional personnel-related
expenses including share based compensation during the three months
ended September 30, 2018.
- General and administrative expenses were $4.0 million for the
three months ended September 30, 2018, as compared to $2.4 million
for the three months ended September 30, 2017. The increase was
primarily attributable to additional personnel-related expenses,
including share based compensation, to support the Company’s
growth.
Financial Guidance
AnaptysBio expects that its cash, cash equivalents and
investments will fund its current operating plan at least
through the end of 2020.
About Etokimab
Etokimab, previously referred to as ANB020, is an antibody
that potently binds and inhibits the activity of interleukin-33, or
IL-33, a pro-inflammatory cytokine that multiple studies have
indicated is a central mediator of atopic diseases,
which AnaptysBio believes is broadly applicable to the
treatment of atopic inflammatory disorders, such as atopic
dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal
polyps, or CRSwNP, and potentially other allergic conditions.
Following completion of a healthy volunteer Phase 1 trial of
etokimab, AnaptysBio continued clinical development of
etokimab into a Phase 2a trial for moderate-to-severe adult atopic
dermatitis and a placebo-controlled Phase 2a trial in severe adult
eosinophilic asthma patients. AnaptysBio is enrolling its
ATLAS trial, a randomized, double-blinded, placebo-controlled
multi-dose Phase 2b clinical trial of etokimab in 300
moderate-to-severe adult atopic dermatitis patients where data is
anticipated in the second half of 2019. The company has also
initiated its ECLIPSE trial, a randomized, double-blinded,
placebo-controlled Phase 2 trial of etokimab in approximately 100
adult patients with CRSwNP with data anticipated in the second half
of 2019. AnaptysBio also plans to initiate a randomized,
double-blinded, placebo-controlled, multi-dose Phase 2b trial of
etokimab in patients with eosinophilic asthma in 2019.
About ANB019
ANB019 is an antibody that inhibits the function of the
interleukin-36-receptor, or IL-36R, which AnaptysBio plans to
initially develop as a potential first-in-class therapy for
patients suffering from generalized pustular psoriasis, or GPP and
palmoplantar pustulosis, or PPP. AnaptysBio conducted a Phase 1
clinical trial in healthy volunteers, where 54 subjects are dosed
with ANB019 and 18 are dosed with placebo in single and multi-dose
cohorts at various subcutaneous and intravenously administered dose
levels. In May 2018, AnaptysBio presented data from this Phase 1
clinical trial, which demonstrated favorable safety,
pharmacokinetics and pharmacodynamic properties that support
advancement of ANB019 into Phase 2 studies. AnaptysBio is enrolling
its GALLOP trial, a Phase 2 study of ANB019 in GPP where data is
anticipated in the second quarter of 2019, and have initiated its
POPLAR trial, a Phase 2 study in PPP where data is anticipated in
the second half of 2019.
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,
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, previously referred to as
palmo-plantar pustular psoriasis; and 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 and an
inflammation partnership with Celgene, including an anti-PD-1
antagonist antibody (TSR-042), an anti-TIM-3 antagonist antibody
(TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), which
are currently under clinical development with TESARO, and an
anti-PD-1 checkpoint agonist antibody (CC-90006) currently in the
clinic with Celgene.
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 2a clinical trial in severe
adult eosinophilic asthma patients, etokimab’s Phase 2b
clinical trial in moderate-to-severe adult atopic dermatitis
patients, 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, and the timing of and our ability
to launch a Phase 2b clinical trial of etokimab in eosinophilic
asthma patients, and the success of our partnership with TESARO and
Celgene. 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:Dominic PiscitelliAnaptysBio,
Inc.858.362.6348dpiscitelli@anaptysbio.com
ANAPTYSBIO,
INC.CONSOLIDATED BALANCE
SHEETS(in thousands, except par value
data)
|
September 30, 2018 |
|
December 31, 2017 |
|
(unaudited) |
|
|
ASSETS |
Current assets: |
|
|
|
Cash and cash
equivalents |
$ |
293,408 |
|
|
$ |
81,189 |
|
Receivable from
collaborative partners |
5,000 |
|
|
— |
|
Australian tax
incentive receivable |
173 |
|
|
1,601 |
|
Short-term
investments |
200,406 |
|
|
167,218 |
|
Prepaid expenses and
other current assets |
4,035 |
|
|
2,688 |
|
Total
current assets |
503,022 |
|
|
252,696 |
|
Property and equipment,
net |
1,344 |
|
|
665 |
|
Long-term
investments |
18,616 |
|
|
75,897 |
|
Other long-term
assets |
79 |
|
|
46 |
|
Restricted cash |
60 |
|
|
60 |
|
Total
assets |
$ |
523,121 |
|
|
$ |
329,364 |
|
LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS’
EQUITY |
Current
liabilities: |
|
|
|
Accounts payable |
$ |
6,180 |
|
|
$ |
2,323 |
|
Accrued expenses |
7,145 |
|
|
4,875 |
|
Notes payable, current
portion |
7,500 |
|
|
6,875 |
|
Other current
liabilities |
48 |
|
|
17 |
|
Total
current liabilities |
20,873 |
|
|
14,090 |
|
Notes payable, net of
current portion |
2,409 |
|
|
7,553 |
|
Deferred rent |
162 |
|
|
140 |
|
Stockholders’
equity: |
|
|
|
Preferred stock, $0.001
par value, 10,000 shares authorized and no shares, issued or
outstanding at September 30, 2018 and December 31, 2017,
respectively |
— |
|
|
— |
|
Common stock, $0.001
par value, 500,000 shares authorized, 26,749 shares and 23,791
shares issued and outstanding at September 30, 2018 and December
31, 2017, respectively |
27 |
|
|
24 |
|
Additional paid in
capital |
629,887 |
|
|
393,017 |
|
Accumulated other
comprehensive loss |
(541 |
) |
|
(426 |
) |
Accumulated
deficit |
(129,696 |
) |
|
(85,034 |
) |
Total
stockholders’ equity |
499,677 |
|
|
307,581 |
|
Total
liabilities, preferred stock and stockholders’ equity |
$ |
523,121 |
|
|
$ |
329,364 |
|
|
|
|
|
|
|
|
|
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, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Collaboration revenue |
$ |
5,000 |
|
|
$ |
— |
|
|
$ |
5,000 |
|
|
$ |
7,000 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
17,883 |
|
|
6,697 |
|
|
40,276 |
|
|
21,837 |
|
General and administrative |
4,004 |
|
|
2,390 |
|
|
11,783 |
|
|
6,793 |
|
Total operating expenses |
21,887 |
|
|
9,087 |
|
|
52,059 |
|
|
28,630 |
|
Loss from operations |
(16,887 |
) |
|
(9,087 |
) |
|
(47,059 |
) |
|
(21,630 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
Interest expense |
(400 |
) |
|
(452 |
) |
|
(1,287 |
) |
|
(1,319 |
) |
Change in fair value of liability for preferred
stock warrants |
— |
|
|
— |
|
|
— |
|
|
(1,366 |
) |
Interest income |
1,369 |
|
|
358 |
|
|
3,851 |
|
|
762 |
|
Other income (expense), net |
(40 |
) |
|
91 |
|
|
(167 |
) |
|
344 |
|
Total other income (expense), net |
929 |
|
|
(3 |
) |
|
2,397 |
|
|
(1,579 |
) |
Net loss |
(15,958 |
) |
|
(9,090 |
) |
|
(44,662 |
) |
|
(23,209 |
) |
Unrealized income (loss) on available for sale securities |
136 |
|
|
16 |
|
|
(115 |
) |
|
(43 |
) |
Other comprehensive income (loss) |
136 |
|
|
16 |
|
|
(115 |
) |
|
(43 |
) |
Comprehensive loss |
$ |
(15,822 |
) |
|
$ |
(9,074 |
) |
|
$ |
(44,777 |
) |
|
$ |
(23,252 |
) |
Net loss per common share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.66 |
) |
|
$ |
(0.45 |
) |
|
$ |
(1.86 |
) |
|
$ |
(1.24 |
) |
Weighted-average number of shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
24,146 |
|
|
20,382 |
|
|
23,961 |
|
|
18,668 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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