AnaptysBio Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
March 01 2023 - 3:05PM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today reported operating results for the fourth quarter and year
ended December 31, 2022 and provided business updates.
“2022 was a significant year of transition for AnaptysBio as we
refocused the company on broadly advancing our portfolio of
best-in-class immune cell modulators. We are excited by the
near-term initiation of our two global Phase 2b trials across
rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ANB032,
our BTLA agonist, in atopic dermatitis. We believe their mechanisms
of action have the potential to meaningfully impact large and
significantly underserved patient populations, to restore immune
balance by acting directly on cell types mediating disease
pathology,” said Daniel Faga, interim president and chief executive
officer of AnaptysBio. “As we continue to progress our strategic
portfolio review, we are well capitalized to deliver on multiple
Phase 2 readouts across our wholly owned checkpoint agonists, as
well as to advance ANB033, our anti-CD122 antagonist, through
clinical proof-of-concept.”
Rosnilimab (PD-1 agonist antibody)
- Rosnilimab, its investigational wholly
owned PD-1 agonist, demonstrates best-in-class activity in vitro
with superior inhibition of T cell proliferation, reduction in
inflammatory cytokine secretion (Th1, Th2, Th17) and depletion of
PD-1+ T cells via effector function compared to Lilly PD-1
agonist
- PD-1+ T cells are clinically validated
drivers of disease in rheumatoid arthritis (RA)
- RA patient synovial biopsies have dense
T cell infiltrates, with >80% of T cells expressing PD-1 and
insufficient PD-L1 expression to down-regulate T cell activity
- Rosnilimab targets multiple distinct
inflammatory mechanisms addressed by approved therapies to treat
RA
- Initiation in Q3 2023 of a global Phase
2b trial in moderate-to-severe RA
- Multi-hundred patient
placebo-controlled trial assessing three dose levels of
subcutaneously administered rosnilimab for approximately 6 months
on well-established endpoints including ACR20/50/70 and DAS28
- Top-line interim data anticipated by
mid-year 2025
- Second global Phase 2 trial, in an
indication to be announced, with study initiation anticipated by
year-end 2023
ANB032 (BTLA agonist antibody)
- ANB032, its investigational wholly
owned BTLA agonist, demonstrates best-in-class activity in vitro
with superior inhibition of T cell proliferation and reduction in
inflammatory cytokine secretion (Th1, Th2, Th17) compared to Lilly
BTLA agonist
- While Th2 targeted therapies provide
benefit to patients with chronic moderate-to-severe atopic
dermatitis (AD), there is compelling evidence that AD is broader
than a Th2 driven disease, as Th1, Th17 and other cell types,
including dendritic cells, may contribute significantly to its
pathogenesis
- ANB032 inhibits inflammatory activity
of Th1, Th2 and Th17 and modulates additional cell types such as B
cells and dendritic cells, with the potential for broader, deeper
and more durable responses than more narrowly targeted
interventions
- Initiation in Q2 2023 of a global Phase
2b trial in moderate-to-severe AD
- 160 patient placebo-controlled trial
assessing three dose levels of subcutaneously administered ANB032
(randomized 1:1:1:1) for 12 weeks on well-established endpoints,
including EASI75 and IGA 0/1
- Top-line interim data anticipated by
year-end 2024
ANB033 (anti-CD122 antagonist antibody)
- ANB033, its investigational wholly
owned anti-CD122 antagonist antibody, targets the common beta
subunit shared by the IL-15 and IL-2 receptors
- IL-15 signaling mediates the survival
and maintenance of tissue resident memory T cells (TRM)
- The presence of long-lived and
persistent TRM have been shown to drive tissue-specific
immune-mediated inflammation
- IND anticipated H1 2024
Legacy Clinical-Stage Cytokine Antagonist Programs
Available for Out-Licensing
- Imsidolimab, its investigational wholly
owned anti-IL-36R antagonist antibody, is in Phase 3 trials for
generalized pustular psoriasis (GPP)
- Top-line data from the GEMINI-1 Phase 3
trial anticipated Q4 2023
- Plan to out-license imsidolimab prior
to potential FDA approval
- Etokimab, its investigational wholly
owned anti-IL-33 antagonist antibody, is Phase 2/3-ready for the
treatment of respiratory disorders
- No further internal investment in
etokimab is being pursued
GSK Immuno-Oncology Financial Collaboration
- Dostarlimab, an anti-PD-1 antagonist
antibody, cobolimab, an anti-TIM-3 antagonist antibody, and
GSK4074386, an anti-LAG-3 antagonist antibody, were discovered at
AnaptysBio and licensed by GSK
- JEMPERLI (dostarlimab-gxly) has the
potential for a first-in-class approval in primary advanced or
recurrent endometrial cancer after meeting the primary endpoint in
the pivotal RUBY Phase 3 trial demonstrating JEMPERLI plus
chemotherapy significantly improved PFS versus chemotherapy plus
placebo
- Regulatory submissions anticipated H1
2023
- GSK expects to publish full results in
a medical journal and present at an upcoming scientific
meeting
- Dostarlimab plus ZEJULA in the pivotal
FIRST Phase 3 trial in 1st line ovarian cancer is ongoing with an
interim analysis expected in H2 2023
- Dostarlimab plus cobolimab plus
chemotherapy vs. dostarlimab plus chemotherapy is in the pivotal
COSTAR Lung Phase 3 trial in advanced non-small cell lung cancer in
patients who have progressed on prior anti-PD-(L)1 therapy
Stock Repurchase Plan
- In January 2023, the Board of Directors
authorized a Stock Repurchase Plan under which the Company may
repurchase up to $50.0 million of the Company’s outstanding common
stock. The Stock Repurchase Plan will expire on December 31, 2023,
may be suspended or discontinued at any time, and does not obligate
the company to acquire any amount of common stock.
Fourth Quarter Financial Results
- Cash, cash equivalents and investments
totaled $584.2 million as of December 31, 2022, compared to
$615.2 million as of December 31, 2021, for a decrease of
$31.0 million. The decrease relates primarily to cash used for
operating activities offset by cash received from the Zejula
royalty sale and stock option exercises.
- Collaboration revenue was $6.8 million
and $10.3 million for the three and twelve months ended
December 31, 2022, compared to $1.0 million and $63.2 million
for the three and twelve months ended December 31, 2021. The
increase for the three months ended December 31, 2022 relates
primarily to one development milestone achieved for cobolimab and
no development milestones achieved during the three months ended
December 31, 2021. The decrease for the twelve months ended
December 31, 2022 relates primarily to four development milestones
achieved for JEMPERLI for the twelve months ended December 31,
2021, and one development milestone achieved during the twelve
months ended December 31, 2022.
- Research and development expenses were
$23.4 million and $88.8 million for the three and twelve months
ended December 31, 2022, compared to $26.8 million and $98.5
million for the three and twelve months ended December 31,
2021. The decrease for the three and twelve months ended December
31, 2022 was due primarily to reduced clinical and manufacturing
costs for the Company’s programs. The R&D non-cash, stock-based
compensation expense was $1.8 million and $6.8 million for the
three and twelve months ended December 31, 2022, as compared to
$1.5 million and $5.9 million in the same period in 2021.
- General and administrative expenses
were $9.4 million and $36.6 million for the three and twelve months
ended December 31, 2022, compared to $5.4 million and $21.5
million for the three and twelve months ended December 31,
2021. The increase was primarily due to stock compensation expense
and $3.8 million of costs incurred from personnel changes in the
first quarter of 2022. The G&A non-cash, stock-based
compensation expense was $4.9 million and $20.6 million for the
three and twelve months ended December 31, 2022, which includes
$3.2 million of the $3.8 million one-time costs described earlier
as compared to $2.5 million and $9.5 million in the same period in
2021.
- Non-cash interest expense was $4.3
million and $21.1 million for the three and twelve months ended
December 31, 2022, compared to $1.5 million for the three and
twelve months ended December 31, 2021. The increase in
non-cash interest expense during the period is directly related to
the interest expense accrued on the liability related to the sale
of future royalties, of which we had a full year of expense during
2022 as compared to one month of expense during 2021. We also had
an additional sale of future royalties in 2022 compared to period
in 2021.
- Net loss was $26.4 million and $128.7
million for the three and twelve months ended December 31,
2022, or a net loss per share of $0.93 and $4.57, compared to a net
loss of $32.5 million and $57.8 million for the three and twelve
months ended December 31, 2021, or a net loss per share of
$1.18 and $2.11.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company focused on
delivering innovative immunology therapeutics. It is developing
immune cell modulators, including two checkpoint agonists in
clinical-stage development, for autoimmune and inflammatory
disease: rosnilimab, its PD-1 agonist, in a planned Phase 2b trial
for the treatment of moderate-to-severe rheumatoid arthritis; and
ANB032, its BTLA agonist, in a planned Phase 2b trial for the
treatment of moderate-to-severe atopic dermatitis. Its preclinical
immune cell modulator portfolio includes ANB033, an anti-CD122
antagonist antibody for the treatment of autoimmune and
inflammatory diseases. In addition, AnaptysBio has developed two
cytokine antagonists available for out-licensing: imsidolimab, an
anti-IL-36R antagonist, in Phase 3 for the treatment of generalized
pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist
for the treatment of respiratory disorders that is Phase 2/3 ready.
AnaptysBio has also discovered multiple therapeutic antibodies
licensed to GSK in a financial collaboration for immune-oncology,
including an anti-PD-1 antagonist antibody (JEMPERLI
(dostarlimab-gxly)), 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 initiation of the company’s clinical
trials, including rosnilimab’s clinical trials in rheumatoid
arthritis and in a second indication and ANB032’s clinical trial in
atopic dermatitis; the timing of the release of data from the
company’s clinical trials, including imsidolimab’s Phase 3 clinical
trial in GPP, rosnilimab’s Phase 2b clinical trial in rheumatoid
arthritis and ANB032’s Phase 2b clinical trial in atopic
dermatitis; the timing of ANB033’s IND filing; the company’s
ability to find a licensing partner for imsidolimab or etokimab and
the timing of any such transaction; and the company’s projected
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 its
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:Nick MontemaranoSenior Director,
Investor Relations and Strategic CommunicationsAnaptysBio, Inc.
858.732.0178investors@anaptysbio.com
AnaptysBio,
Inc.Consolidated Balance Sheets
(in thousands, except par value data)
|
December 31, 2022 |
|
December 31, 2021 |
ASSETS |
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
71,308 |
|
|
$ |
495,729 |
|
Receivables from collaborative partners |
|
1,419 |
|
|
|
876 |
|
Short-term investments |
|
369,933 |
|
|
|
52,368 |
|
Prepaid
expenses and other current assets |
|
4,545 |
|
|
|
4,903 |
|
Total current assets |
|
447,205 |
|
|
|
553,876 |
|
Property
and equipment, net |
|
2,089 |
|
|
|
2,283 |
|
Operating lease right-of-use assets |
|
17,898 |
|
|
|
19,558 |
|
Long-term investments |
|
142,935 |
|
|
|
67,097 |
|
Other
long-term assets |
|
256 |
|
|
|
256 |
|
Total assets |
$ |
610,383 |
|
|
$ |
643,070 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
2,784 |
|
|
$ |
1,741 |
|
Accrued
expenses |
|
21,633 |
|
|
|
12,853 |
|
Current
portion of operating lease liability |
|
1,637 |
|
|
|
1,505 |
|
Total current liabilities |
|
26,054 |
|
|
|
16,099 |
|
Liability related to sale of future royalties |
|
304,413 |
|
|
|
251,093 |
|
Operating lease liability, net of current portion |
|
17,813 |
|
|
|
19,450 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value, 10,000 shares authorized and no
shares, issued or outstanding at December 31, 2022 and
December 31, 2021, respectively |
|
— |
|
|
|
— |
|
Common
stock, $0.001 par value, 500,000 shares authorized, 28,513 shares
and 27,647 shares issued and outstanding at December 31, 2022
and December 31, 2021, respectively |
|
29 |
|
|
|
28 |
|
Additional paid in capital |
|
717,797 |
|
|
|
678,575 |
|
Accumulated other comprehensive loss |
|
(5,246 |
) |
|
|
(422 |
) |
Accumulated deficit |
|
(450,477 |
) |
|
|
(321,753 |
) |
Total stockholders’ equity |
|
262,103 |
|
|
|
356,428 |
|
Total liabilities and stockholders’ equity |
$ |
610,383 |
|
|
$ |
643,070 |
|
|
|
|
|
|
|
|
|
AnaptysBio, Inc.
Consolidated Statements of Operations and Comprehensive
Loss(in thousands, except per share
data)
|
Three Months EndedDecember 31, |
|
Year EndedDecember 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Collaboration revenue |
$ |
6,808 |
|
|
$ |
1,011 |
|
|
$ |
10,287 |
|
|
$ |
63,175 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
23,374 |
|
|
|
26,776 |
|
|
|
88,798 |
|
|
|
98,496 |
|
General and administrative |
|
9,407 |
|
|
|
5,392 |
|
|
|
36,643 |
|
|
|
21,493 |
|
Total operating expenses |
|
32,781 |
|
|
|
32,168 |
|
|
|
125,441 |
|
|
|
119,989 |
|
Loss from operations |
|
(25,973 |
) |
|
|
(31,157 |
) |
|
|
(115,154 |
) |
|
|
(56,814 |
) |
Other
income (expense), net: |
|
|
|
|
|
|
|
Interest income |
|
3,839 |
|
|
|
68 |
|
|
|
7,550 |
|
|
|
431 |
|
Non-cash interest expense for the sale of future royalties |
|
(4,251 |
) |
|
|
(1,450 |
) |
|
|
(21,108 |
) |
|
|
(1,450 |
) |
Other (expense) income, net |
|
(4 |
) |
|
|
1 |
|
|
|
12 |
|
|
|
37 |
|
Total other expense, net |
|
(416 |
) |
|
|
(1,381 |
) |
|
|
(13,546 |
) |
|
|
(982 |
) |
Loss
before income taxes |
|
(26,389 |
) |
|
|
(32,538 |
) |
|
|
(128,700 |
) |
|
|
(57,796 |
) |
Provision for income taxes |
|
(24 |
) |
|
|
— |
|
|
|
(24 |
) |
|
|
— |
|
Net loss |
|
(26,413 |
) |
|
|
(32,538 |
) |
|
|
(128,724 |
) |
|
|
(57,796 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
Unrealized income (loss) on available for sale securities |
|
761 |
|
|
|
(222 |
) |
|
|
(4,824 |
) |
|
|
(418 |
) |
Comprehensive loss |
$ |
(25,652 |
) |
|
$ |
(32,760 |
) |
|
$ |
(133,548 |
) |
|
$ |
(58,214 |
) |
Net loss
per common share: |
|
|
|
|
|
|
|
Basic
and diluted |
$ |
(0.93 |
) |
|
$ |
(1.18 |
) |
|
$ |
(4.57 |
) |
|
$ |
(2.11 |
) |
Weighted-average number of shares outstanding: |
|
|
|
|
|
|
|
Basic
and diluted |
|
28,446 |
|
|
|
27,534 |
|
|
|
28,165 |
|
|
|
27,431 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AnaptysBio (NASDAQ:ANAB)
Historical Stock Chart
From Jun 2024 to Jul 2024
AnaptysBio (NASDAQ:ANAB)
Historical Stock Chart
From Jul 2023 to Jul 2024