AnaptysBio Announces First Quarter 2022 Financial Results and Provides Pipeline Update
05 May 2022 - 6:15AM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company developing first-in-class antibodies focused on emerging
immune control mechanisms applicable to inflammation and
immuno-oncology indications, today reported operating results for
the first quarter ended March 31, 2022 and provided pipeline
updates.
“We are excited with our recently released Phase 1 trial results
of ANB032, our anti-BTLA agonist, and the potential to broadly
treat T and B-cell driven inflammatory diseases. Our recently
initiated strategic portfolio review will define the path forward
across a breadth of clinical development options of potential
inflammation-focused indications that could be pursued for each of
our clinical and preclinical therapeutic antibody programs,” said
Daniel Faga, interim president and chief executive officer of
AnaptysBio. “We look forward to continuing to execute on our
ongoing clinical trials with multiple readouts throughout the next
18 months.”
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, previously
known as ANB030, is in the AZURE Phase 2 clinical trial in
moderate-to-severe alopecia areata, and we anticipate top-line data
in H1 2023.
ANB032 (Anti-BTLA agonist) Program
- Announced positive
top-line phase 1 data in April 2022 of ANB032, our investigational
wholly owned anti-BTLA agonist antibody, demonstrating favorable
safety and tolerability with no dose limiting toxicities were
observed and no serious adverse events (SAEs) reported.
- ANB032 pharmacokinetic analyses
demonstrated a favorable profile including an approximate two-week
half-life and Full BTLA receptor occupancy rapidly within hours and
was maintained for greater than 30 days.
- ANB032 also demonstrated rapid and
sustained target engagement on both T cells and B cells.
- We are advancing ANB032 with an IND
filing for a Phase 2 clinical trial anticipated in H2 2022.
First Quarter Financial Results
- Cash, cash
equivalents and investments totaled $596.8 million as of
March 31, 2022, compared to $615.2 million as of
December 31, 2021, for a decrease of $18.4 million. The
decrease relates primarily to cash used for operating activities
offset by cash received from stock option exercises.
- Collaboration
revenue was $1.0 million for the three months ended March 31, 2022,
compared to $11.2 million for the three months ended March 31,
2021. The decrease relates primarily to one milestone achieved for
JEMPERLI in the first quarter of 2021 for $10.0 million, and no
milestones achieved in the first quarter of 2022.
- Research and development expenses
were $22.5 million for the three months ended March 31, 2022,
compared to $24.2 million for the three months ended March 31,
2021. The decrease was due primarily to reduced imsidolimab
manufacturing costs offset by increased costs for the Company’s
clinical programs. The R&D non-cash, stock-based compensation
expense was $1.7 million for the three months ended March 31, 2022
as compared to $1.2 million in the same period in 2021.
- General and administrative expenses
were $10.2 million for the three months ended March 31, 2022,
compared to $5.4 million for the three months ended March 31, 2021.
The increase was due primarily to $3.8 million of costs incurred
for our former President and CEO’s resignation in the first quarter
of 2022. The G&A non-cash, stock-based compensation expense was
$6.1 million for the three months ended March 31, 2022 which
includes $3.2 million of the $3.8 million one-time costs described
earlier as compared to $2.1 million in the same period in
2021.
- Net loss was $36.3 million for the
three months ended March 31, 2022, or a net loss per share of
$1.31, compared to a net loss of $18.2 million for the three months
ended March 31, 2021, or a net loss per share of $0.66.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company
developing first-in-class antibodies focused on unmet medical
needs in inflammation. 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)
|
March 31, 2022 |
|
December 31, 2021 |
|
|
|
|
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
166,412 |
|
|
$ |
495,729 |
|
Receivables from collaborative
partners |
|
921 |
|
|
|
876 |
|
Short-term investments |
|
339,209 |
|
|
|
52,368 |
|
Prepaid expenses and other
current assets |
|
5,869 |
|
|
|
4,903 |
|
Total current assets |
|
512,411 |
|
|
|
553,876 |
|
Property and equipment,
net |
|
2,162 |
|
|
|
2,283 |
|
Operating lease right-of-use
assets |
|
19,147 |
|
|
|
19,558 |
|
Long-term investments |
|
91,195 |
|
|
|
67,097 |
|
Other long-term assets |
|
256 |
|
|
|
256 |
|
Total assets |
$ |
625,171 |
|
|
$ |
643,070 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,481 |
|
|
$ |
1,741 |
|
Accrued expenses |
|
15,763 |
|
|
|
12,853 |
|
Current portion of operating
lease liability |
|
1,537 |
|
|
|
1,505 |
|
Total current liabilities |
|
19,781 |
|
|
|
16,099 |
|
Liability related to sale of
future royalties |
|
255,584 |
|
|
|
251,093 |
|
Operating lease liability, net
of current portion |
|
19,059 |
|
|
|
19,450 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par
value, 10,000 shares authorized and no shares, issued or
outstanding at March 31, 2022 and December 31, 2021,
respectively |
|
— |
|
|
|
— |
|
Common stock, $0.001 par
value, 500,000 shares authorized, 28,178 shares and 27,647 shares
issued and outstanding at March 31, 2022 and December 31,
2021, respectively |
|
28 |
|
|
|
28 |
|
Additional paid in
capital |
|
691,161 |
|
|
|
678,575 |
|
Accumulated other
comprehensive loss |
|
(2,434 |
) |
|
|
(422 |
) |
Accumulated deficit |
|
(358,008 |
) |
|
|
(321,753 |
) |
Total stockholders’ equity |
|
330,747 |
|
|
|
356,428 |
|
Total liabilities and stockholders’ equity |
$ |
625,171 |
|
|
$ |
643,070 |
|
AnaptysBio, Inc.
Consolidated Statements of Operations and Comprehensive
Loss(in thousands, except per share data)
(unaudited)
|
Three Months EndedMarch 31, |
|
|
2022 |
|
|
|
2021 |
|
Collaboration revenue |
$ |
970 |
|
|
$ |
11,247 |
|
Operating expenses: |
|
|
|
Research and development |
|
22,516 |
|
|
|
24,185 |
|
General and administrative |
|
10,203 |
|
|
|
5,423 |
|
Total operating expenses |
|
32,719 |
|
|
|
29,608 |
|
Loss from operations |
|
(31,749 |
) |
|
|
(18,361 |
) |
Other income (expense),
net: |
|
|
|
Interest income |
|
342 |
|
|
|
195 |
|
Non-cash interest expense for the sale of future royalties |
|
(4,854 |
) |
|
|
— |
|
Other income, net |
|
6 |
|
|
|
3 |
|
Total other income (expense), net |
|
(4,506 |
) |
|
|
198 |
|
Net loss |
|
(36,255 |
) |
|
|
(18,163 |
) |
Unrealized loss on available for sale securities |
|
(2,012 |
) |
|
|
(107 |
) |
Comprehensive loss |
$ |
(38,267 |
) |
|
$ |
(18,270 |
) |
Net loss per common share: |
|
|
|
Basic and diluted |
$ |
(1.31 |
) |
|
$ |
(0.66 |
) |
Weighted-average number of shares outstanding: |
|
|
|
Basic and diluted |
|
27,713 |
|
|
|
27,361 |
|
AnaptysBio (NASDAQ:ANAB)
Historical Stock Chart
From Jun 2024 to Jul 2024
AnaptysBio (NASDAQ:ANAB)
Historical Stock Chart
From Jul 2023 to Jul 2024