AnaptysBio Announces Second Quarter 2022 Financial Results and Provides Pipeline Update
09 August 2022 - 6:05AM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today reported operating results for the second quarter ended June
30, 2022 and provided pipeline updates.
“We are excited with our progress as we continue to
execute on our ongoing clinical studies and anticipate top-line
data from the imsidolimab HARP Phase 2 trial in moderate-to-severe
hidradenitis suppurativa later this quarter and are pleased to
announce top-line data from the rosnilimab AZURE Phase 2 trial in
moderate-to-severe alopecia areata is now accelerated into Q1
2023,” said Daniel Faga, interim president and chief executive
officer of AnaptysBio. “With over $570 million in cash at the end
of Q2, and reiterating 2022 net cash burn of $90 to $100 million,
Anaptys is well capitalized to execute as we move forward in our
strategic portfolio review.”
Imsidolimab (Anti-IL-36 receptor) Program
- Imsidolimab, our investigational
wholly owned anti-IL-36R therapeutic antibody, is in Phase 3 trials
in generalized pustular psoriasis (GPP), and we anticipate top-line
data from the GEMINI-1 Phase 3 clinical trial in Q4 2023.
- We anticipate top-line data from the
HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa
in Q3 2022.
Rosnilimab (Anti-PD-1 agonist) Program
- Rosnilimab, our investigational
wholly owned anti-PD-1 agonist therapeutic antibody, is in the
AZURE Phase 2 clinical trial in moderate-to-severe alopecia areata,
and we anticipate top-line data in Q1 2023.
ANB032 (Anti-BTLA agonist) Program
- ANB032, our investigational wholly
owned anti-BTLA agonist antibody, recently demonstrated favorable
safety and tolerability with no observed dose limiting toxicities
and no serious adverse events (SAEs) reported, will be advancing
with an IND filing for a Phase 2 clinical trial anticipated in Q4
2022.
Second Quarter Financial Results
- Cash, cash
equivalents and investments totaled $572.1 million as of
June 30, 2022, compared to $615.2 million as of
December 31, 2021, for a decrease of $43.1 million. The
decrease relates primarily to cash used for operating activities
offset by cash received from stock option exercises. Reiterate
anticipated 2022 net cash burn of $90 to $100 million.
- Collaboration
revenue was $1.2 million and $2.2 million for the three and six
months ended June 30, 2022, compared to $30.0 million and $41.3
million for the three months and six months ended June 30, 2021.
The decrease relates primarily to two development milestones
achieved for JEMPERLI for the three months ended June 30, 2021, and
three development milestones achieved for JEMPERLI for the six
months ended June 30, 2021, and no milestones achieved in
2022.
- Research and
development expenses were $20.8 million and $43.4 million for the
three and six months ended June 30, 2022, compared to $25.3 million
and $49.5 million for the three and six months ended June 30, 2021.
The decrease was due primarily to reduced imsidolimab manufacturing
costs and clinical costs for the Company’s programs. The R&D
non-cash stock-based compensation expense was $1.8 million and $3.4
million for the three and six months ended June 30, 2022, as
compared to $1.4 million and $2.6 million in the same period in
2021.
- General and
administrative expenses were $8.2 million and $18.4 million for the
three and six months ended June 30, 2022, compared to $5.2 million
and $10.7 million for the three and six months ended June 30, 2021.
The increase was due primarily to $3.8 million of costs incurred
from personnel changes in the first quarter of 2022 and non-cash
stock compensation expense. The G&A non-cash stock-based
compensation expense was $4.9 million and $11.0 million for the
three and six months ended June 30, 2022, which includes $3.2
million of the $3.8 million one-time costs described earlier as
compared to $2.3 million and $4.4 million in the same period in
2021.
- Net loss was $32.6
million and $68.8 million for the three and six months ended June
30, 2022, or a net loss per share of $1.15 and $2.46, compared to a
net loss of $0.4 million and $18.6 million for the three and six
months ended June 30, 2021, or a net loss per share of $0.02 and
$0.68.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics.
The Company’s proprietary anti-inflammatory pipeline includes
imsidolimab, its anti-IL-36R antibody, previously referred to as
ANB019, for the treatment of dermatological inflammatory diseases,
including generalized pustular psoriasis, or GPP, and
moderate-to-severe hidradenitis suppurativa; rosnilimab, its
anti-PD-1 agonist program, previously referred to as ANB030, for
the treatment of moderate-to-severe alopecia areata; and its
anti-BTLA agonist 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 collaboration with
GSK, including an anti-PD-1 antagonist antibody (JEMPERLI
(dostarlimab-gxly) GSK4057190), an anti-TIM-3 antagonist antibody
(cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody
(GSK4074386).
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 imsidolimab’s Phase 3 clinical trial in
GPP, Phase 2 clinical trial in hidradenitis suppurativa, and
rosnilimab’ s Phase 2 clinical trial in alopecia areata; and the
timing of ANB032’s IND filing for a Phase 2 clinical trial; and our
projected use of our cash resources. 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:Dennis MulroyAnaptysBio,
Inc. 858.732.0201dmulroy@anaptysbio.com
AnaptysBio,
Inc.Consolidated Balance Sheets
(in thousands, except par value
data)(unaudited)
|
June 30, 2022 |
|
December 31, 2021 |
|
|
|
|
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
71,701 |
|
|
$ |
495,729 |
|
Receivables from collaborative
partners |
|
1,033 |
|
|
|
876 |
|
Short-term investments |
|
370,450 |
|
|
|
52,368 |
|
Prepaid expenses and other
current assets |
|
9,625 |
|
|
|
4,903 |
|
Total current assets |
|
452,809 |
|
|
|
553,876 |
|
Property and equipment,
net |
|
2,059 |
|
|
|
2,283 |
|
Operating lease right-of-use
assets |
|
18,739 |
|
|
|
19,558 |
|
Long-term investments |
|
129,985 |
|
|
|
67,097 |
|
Other long-term assets |
|
256 |
|
|
|
256 |
|
Total assets |
$ |
603,848 |
|
|
$ |
643,070 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
1,587 |
|
|
$ |
1,741 |
|
Accrued expenses |
|
16,714 |
|
|
|
12,853 |
|
Current portion of operating
lease liability |
|
1,570 |
|
|
|
1,505 |
|
Total current liabilities |
|
19,871 |
|
|
|
16,099 |
|
Liability related to sale of
future royalties |
|
261,019 |
|
|
|
251,093 |
|
Operating lease liability, net
of current portion |
|
18,652 |
|
|
|
19,450 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par
value, 10,000 shares authorized and no shares, issued or
outstanding at June 30, 2022 and December 31, 2021,
respectively |
|
— |
|
|
|
— |
|
Common stock, $0.001 par
value, 500,000 shares authorized, 28,231 shares and 27,647 shares
issued and outstanding at June 30, 2022 and December 31,
2021, respectively |
|
28 |
|
|
|
28 |
|
Additional paid in
capital |
|
698,701 |
|
|
|
678,575 |
|
Accumulated other
comprehensive loss |
|
(3,861 |
) |
|
|
(422 |
) |
Accumulated deficit |
|
(390,562 |
) |
|
|
(321,753 |
) |
Total stockholders’ equity |
|
304,306 |
|
|
|
356,428 |
|
Total liabilities and stockholders’ equity |
$ |
603,848 |
|
|
$ |
643,070 |
|
|
|
|
|
|
|
|
|
AnaptysBio, Inc.
Consolidated Statements of Operations and Comprehensive
Loss(in thousands, except per share data)
(unaudited)
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Collaboration revenue |
$ |
1,216 |
|
|
$ |
30,027 |
|
|
$ |
2,186 |
|
|
$ |
41,274 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
20,844 |
|
|
|
25,314 |
|
|
|
43,360 |
|
|
|
49,499 |
|
General and administrative |
|
8,171 |
|
|
|
5,246 |
|
|
|
18,374 |
|
|
|
10,669 |
|
Total operating expenses |
|
29,015 |
|
|
|
30,560 |
|
|
|
61,734 |
|
|
|
60,168 |
|
Loss from operations |
|
(27,799 |
) |
|
|
(533 |
) |
|
|
(59,548 |
) |
|
|
(18,894 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
Interest income |
|
1,107 |
|
|
|
104 |
|
|
|
1,449 |
|
|
|
299 |
|
Non-cash interest expense for the sale of future royalties |
|
(5,868 |
) |
|
|
— |
|
|
|
(10,722 |
) |
|
|
— |
|
Other income, net |
|
6 |
|
|
|
— |
|
|
|
12 |
|
|
|
3 |
|
Total other income (expense), net |
|
(4,755 |
) |
|
|
104 |
|
|
|
(9,261 |
) |
|
|
302 |
|
Net loss |
|
(32,554 |
) |
|
|
(429 |
) |
|
|
(68,809 |
) |
|
|
(18,592 |
) |
Unrealized loss on available for sale securities |
|
(1,427 |
) |
|
|
(65 |
) |
|
|
(3,439 |
) |
|
|
(172 |
) |
Comprehensive loss |
$ |
(33,981 |
) |
|
$ |
(494 |
) |
|
$ |
(72,248 |
) |
|
$ |
(18,764 |
) |
Net loss per common share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(1.15 |
) |
|
$ |
(0.02 |
) |
|
$ |
(2.46 |
) |
|
$ |
(0.68 |
) |
Weighted-average number of shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
28,204 |
|
|
|
27,391 |
|
|
|
27,960 |
|
|
|
27,377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AnaptysBio (NASDAQ:ANAB)
Historical Stock Chart
From Jun 2024 to Jul 2024
AnaptysBio (NASDAQ:ANAB)
Historical Stock Chart
From Jul 2023 to Jul 2024