AnaptysBio Announces Third Quarter 2017 Financial Results and Provides Pipeline Updates
November 07 2017 - 6:00AM
Announced Positive Proof-of-Concept Data for
ANB020 in Atopic Dermatitis
AnaptysBio, Inc. (Nasdaq:ANAB), a clinical-stage biotechnology
company developing first-in-class antibody product candidates
focused on unmet medical needs in inflammation, today provided
pipeline updates and reported third quarter 2017 financial results.
“Throughout 2017, we are continuing to execute on our strategy
of developing first-in-class antibody therapeutics for patients
with severe inflammatory diseases and have recently announced
positive proof-of-concept data for our wholly-owned ANB020 program
in adults with moderate-to-severe atopic dermatitis,”
said Hamza Suria, president and chief executive officer of
AnaptysBio. “We are on track to report top-line data from our
on-going ANB020 Phase 2a studies in severe adult peanut allergy,
and severe adult eosinophilic asthma during the first and second
quarters of 2018, respectively. Our wholly-owned ANB019 program
generated positive top-line Phase 1 healthy volunteer data and we
plan to advance this program into Phase 2 orphan inflammatory
disease patients studies during 2018.”
Pipeline and Business Highlights
ANB020 (Anti-IL-33 Program)
- In October, the company reported positive proof-of-concept data
for ANB020, its investigational anti-IL-33 therapeutic antibody, in
an ongoing Phase 2a clinical trial in adult patients with
moderate-to-severe atopic dermatitis. After a single dose of
ANB020, 75 percent of patients achieved an Eczema Area Severity
Index (EASI) score improvement of 50 percent relative to enrollment
baseline (EASI-50) at day 15, 83 percent of patients achieved
EASI-50 at day 29 and 75 percent of patients achieved EASI-50 at
day 57. All 12 patients achieved EASI-50 at one or more time points
through Day 57 post-ANB020 administration. ANB020 was generally
well tolerated in all patients as of this interim analysis. During
the first half of 2018, AnaptysBio plans to initiate a Phase 2b
randomized, double-blinded, placebo-controlled study in 200-300
adult patients with moderate-to-severe atopic dermatitis to
evaluate multi-dose subcutaneous administration of ANB020, with
data expected in 2019.
- Enrollment continued in the company’s ongoing Phase 2a
double-blinded, placebo-controlled trial assessing the tolerance of
oral food challenge before and after administration of a single
dose of ANB020 or placebo in a total of 20 adult patients with
severe peanut allergy. As of October 31, 2017, 75 percent of the
study has been enrolled and top-line data are expected in the first
quarter of 2018.
- Enrollment was initiated in the company’s an ongoing
double-blinded, placebo-controlled Phase 2a trial in 24 adult
patients with severe eosinophilic asthma, with top-line results,
including a Forced Expiratory Volume in One Second (FEV1)
assessment of patients administered a single dose of ANB020 or
placebo, with top-line data expected in the second quarter of
2018.
ANB019 (Anti-IL-36 Receptor Program)
- The Company announced positive top-line results from an interim
analysis of an ongoing single and multiple ascending dose healthy
volunteer Phase 1 trial of ANB019, its investigational
anti-interleukin-36 receptor (IL-36R) therapeutic antibody.
Top-line data showed favorable safety, pharmacokinetics and
pharmacodynamic properties that support advancement of ANB019 into
Phase 2 studies for generalized pustular psoriasis and
palmo-plantar pustular psoriasis during 2018.
Business Update
- On Oct. 17, 2017, the company completed an underwritten public
offering selling 3,000,000 shares of common stock at a price to the
public of $68.50 per share. The aggregate net proceeds received by
the company from the offering were $194.7 million, net of
underwriting discounts and commissions.
- In August, the company announced the appointment of J. Anthony
Ware, M.D. to its board of directors. Dr. Ware currently
serves as the senior vice president of product development of Lilly
Bio-Medicines at Eli Lilly and Company, where he is responsible for
the clinical development and regulatory approval of new medicines
in multiple therapeutic areas.
Financial Results and Financial Guidance
- Cash, cash equivalents and investments totaled $116.7 million
as of September 30, 2017, which includes net proceeds of $80.2
million from the company’s initial public offering completed in
January 2017, compared to $51.2 million as of December 31, 2016.
Including the net proceeds from the company’s follow-on offering in
October 2017, of approximately $194.7 million, the company
expects that it has sufficient capital to fund its
operating plan through the end of 2019.
- Revenue was zero and $7.0 million for the three and nine months
ended September 30, 2017, respectively as compared to $3.2
million and $13.9 million for the three and nine months ended
September 30, 2016, respectively. The nine months ended
September 30, 2017 included revenue related to two milestones
earned from the company’s partnership with TESARO. The three and
nine months ended September 30, 2016 included revenue of
related to the amortization of the upfront payment from TESARO,
research and development services with TESARO and milestone-related
revenues from TESARO and Celgene. The upfront payment was fully
recognized and the research and development services were completed
as of December 31, 2016.
- Research and development expenses were $6.7 million and $21.8
million, respectively, for the three and nine months ended
September 30, 2017, as compared to $3.3 million and $10.4
million, respectively, for the three and nine months ended
September 30, 2016. The increase was primarily due to an
increase in preclinical and clinical trial expenses as well as the
recognition of higher research and development tax incentives in
the three and nine months ended September 30, 2016.
- General and administrative expenses were $2.4 million and $6.8
million, respectively, for the three and nine months ended
September 30, 2017, as compared to $1.0 million and $3.4
million, respectively, for the three and six months ended
September 30, 2016. The increase was attributable to
additional personnel-related expenses, including non-cash
stock-based compensation, and an increase in public company related
expenses.
About AnaptysBioAnaptysBio 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 (ANB020) for the treatment of
moderate-to-severe adult atopic dermatitis, severe adult peanut
allergy and severe adult eosinophilic asthma; its anti-IL-36R
antibody (ANB019) for the treatment of rare inflammatory diseases,
including generalized pustular psoriasis and palmo-plantar pustular
psoriasis; and a portfolio of checkpoint receptor agonist
antibodies for the treatment of certain autoimmune diseases where
immune checkpoint receptors are insufficiently activated, which
have demonstrated efficacy in an animal model of graft-versus-host
disease. AnaptysBio’s antibody pipeline has been developed using
its proprietary somatic hypermutation (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 StatementsThis 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 ANB020’s Phase 2a and
Phase 2b clinical trials in adults with moderate-to-severe atopic
dermatitis, Phase 2a clinical trials for the treatment of severe
peanut allergy and severe adult eosinophilic asthma and Phase 1
clinical trial of ANB019; our ability to launch a Phase 2b clinical
trial of ANB020 in adults with moderate-to-severe atopic dermatitis
and Phase 2 clinical trials of ANB019; and the success of our
partnership with TESARO. 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:Chelcie ListerTHRUST Investor
Relations910.777.3049chelcie@thrustir.com
| ANAPTYSBIO, INC.CONSOLIDATED
BALANCE SHEETS(in thousands, except par value
data) |
| |
| |
September 30, 2017 |
|
December 31, 2016 |
| |
(unaudited) |
|
|
| ASSETS |
| Current assets: |
|
|
|
| Cash and cash
equivalents |
$ |
26,669 |
|
|
$ |
51,232 |
|
| Receivable from
collaborative partners |
— |
|
|
1,225 |
|
| Australian tax
incentive receivable |
1,486 |
|
|
4,118 |
|
| Short-term
investments |
89,053 |
|
|
— |
|
| Prepaid expenses and
other current assets |
3,119 |
|
|
1,633 |
|
| Total
current assets |
120,327 |
|
|
58,208 |
|
| Property and equipment,
net |
513 |
|
|
471 |
|
| Long-term
investments |
999 |
|
|
— |
|
| Long-term vendor
deposits |
46 |
|
|
— |
|
| Restricted cash |
60 |
|
|
60 |
|
| Deferred financing
costs |
— |
|
|
3,441 |
|
| Total
assets |
$ |
121,945 |
|
|
$ |
62,180 |
|
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
| Current
liabilities: |
|
|
|
| Accounts payable |
$ |
2,557 |
|
|
$ |
2,278 |
|
| Accrued expenses |
3,604 |
|
|
3,429 |
|
| Notes payable, current
portion |
5,000 |
|
|
— |
|
| Other current
liabilities |
13 |
|
|
1 |
|
| Total
current liabilities |
11,174 |
|
|
5,708 |
|
| Notes payable, net of
current portion |
9,269 |
|
|
13,809 |
|
| Deferred rent |
147 |
|
|
154 |
|
| Preferred stock warrant
liabilities |
— |
|
|
3,241 |
|
| Commitments and
contingencies |
|
|
|
| Series B convertible
preferred stock, $0.001 par value, no shares and 3,963 authorized,
issued and outstanding at September 30, 2017 and December 31,
2016, respectively |
— |
|
|
28,220 |
|
| Series C convertible
preferred stock, $0.001 par value, no shares and 1,887 shares
authorized, no shares and 1,593 shares issued and outstanding
at September 30, 2017 and December 31, 2016, respectively |
— |
|
|
6,452 |
|
| Series C-1 convertible
preferred stock, $0.001 par value, no shares and 474 shares
authorized, issued and outstanding at September 30, 2017 and
December 31, 2016, respectively |
— |
|
|
2,156 |
|
| Series D convertible
preferred stock, $0.001 par value, no shares and 5,491 shares
authorized, issued and outstanding at September 30, 2017 and
December 31, 2016, respectively |
— |
|
|
40,688 |
|
| Stockholders’ equity
(deficit): |
|
|
|
| Preferred stock, $0.001
par value, 10,000 shares and no shares authorized, issued or
outstanding at September 30, 2017 and December 31, 2016,
respectively |
— |
|
|
— |
|
| Common stock, $0.001
par value, 500,000 and 17,214 authorized, 20,496 shares and 2,651
shares issued and outstanding at September 30, 2017 and
December 31, 2016, respectively |
20 |
|
|
3 |
|
| Additional paid in
capital |
179,551 |
|
|
16,672 |
|
| Accumulated other
comprehensive loss |
(43 |
) |
|
— |
|
| Accumulated
deficit |
(78,173 |
) |
|
(54,923 |
) |
| Total
stockholders’ equity (deficit) |
101,355 |
|
|
(38,248 |
) |
|
Total liabilities, convertible preferred stock and
stockholders’ equity (deficit) |
$ |
121,945 |
|
|
$ |
62,180 |
|
|
|
|
|
|
|
|
|
|
| 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, |
| |
2017 |
|
2016 |
|
2017 |
|
2016 |
| Collaboration
revenue |
$ |
— |
|
|
$ |
3,214 |
|
|
$ |
7,000 |
|
|
$ |
13,930 |
|
| Operating
expenses: |
|
|
|
|
|
|
|
| Research
and development |
6,697 |
|
|
3,282 |
|
|
21,837 |
|
|
10,403 |
|
| General
and administrative |
2,390 |
|
|
1,007 |
|
|
6,793 |
|
|
3,378 |
|
| Total
operating expenses |
9,087 |
|
|
4,289 |
|
|
28,630 |
|
|
13,781 |
|
|
Income (loss) from operations |
(9,087 |
) |
|
(1,075 |
) |
|
(21,630 |
) |
|
149 |
|
| Other income (expense),
net |
|
|
|
|
|
|
|
| Interest
expense |
(452 |
) |
|
(116 |
) |
|
(1,319 |
) |
|
(347 |
) |
| Change in
fair value of liability for preferred stock warrants |
— |
|
|
(47 |
) |
|
(1,366 |
) |
|
335 |
|
| Other
income, net |
449 |
|
|
123 |
|
|
1,106 |
|
|
182 |
|
| Total
other income (expense), net |
(3 |
) |
|
(40 |
) |
|
(1,579 |
) |
|
170 |
|
| Net
income (loss) |
(9,090 |
) |
|
(1,115 |
) |
|
(23,209 |
) |
|
319 |
|
| Net income attributed
to participating securities |
— |
|
|
— |
|
|
— |
|
|
(319 |
) |
| Net loss attributed to
common stockholders |
(9,090 |
) |
|
(1,115 |
) |
|
(23,209 |
) |
|
— |
|
|
Unrealized income (loss) on available for sale securities |
16 |
|
|
— |
|
|
(43 |
) |
|
— |
|
| Other
comprehensive income (loss) |
16 |
|
|
— |
|
|
(43 |
) |
|
— |
|
|
Comprehensive loss |
$ |
(9,074 |
) |
|
$ |
(1,115 |
) |
|
$ |
(23,252 |
) |
|
$ |
— |
|
| Net loss
per common share: |
|
|
|
|
|
|
|
|
Basic |
$ |
(0.45 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.24 |
) |
|
$ |
— |
|
|
Diluted |
$ |
(0.45 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.24 |
) |
|
$ |
— |
|
|
Weighted-average number of shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
20,382 |
|
|
2,636 |
|
|
18,668 |
|
|
2,633 |
|
|
Diluted |
20,382 |
|
|
2,636 |
|
|
18,668 |
|
|
3,467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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