AnaptysBio Announces Second Quarter 2023 Financial Results and Provides Business Update
08 August 2023 - 6:15AM
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, 2023 and provided a business update.
"We have made substantial operating progress including
initiating a Phase 2b trial in atopic dermatitis (AD) for ANB032,
our BTLA agonist, and approaching initiation of a Phase 2b trial in
RA for rosnilimab, our PD-1 agonist,” said Daniel Faga, president
and chief executive officer of AnaptysBio. “Additionally, we are
excited to share that we recently completed enrollment of the
GEMINI-1 Phase 3 clinical trial for imsidolimab in GPP and expect
to share top-line data in Q4 2023.”
“We are excited to appoint Dan Faga to the permanent position of
president and CEO,” said Jamie Topper, M.D., Ph. D., chairman
of the Board of Directors. “Over the last year, Anaptys has
completed its strategic portfolio review and Dan led the transition
refocusing on the broad development of our differentiated immune
cell modulators, including our checkpoint agonist pipeline, in
autoimmune and inflammatory diseases. With Dan and his talented
team in place, and our strong capital position, the company is well
positioned as it enters its next phase of development and
growth.”
Updates on Wholly Owned Immune Cell Modulator
Pipeline
ANB032 (BTLA agonist antibody)
- Initiated 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 a 14-week treatment duration and six-month follow-up period on
well established endpoints, including EASI75 and IGA 0/1
- Top-line week 14 data anticipated by year-end 2024
- Hosted a virtual BTLA Agonist (ANB032) R&D Event in May
2023
- Replay of the audio webcast is available here
Rosnilimab (PD-1 agonist antibody)
- Anticipate initiation later 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 up to six
months on well-established endpoints including ACR20/50/70 and
DAS28
- Top-line week 12 data anticipated by mid-year 2025
- Plan to initiate a second global Phase 2 trial, in a yet
to-be-announced indication, by year-end 2023
- Plan to host a virtual PD-1 Agonist (rosnilimab) R&D Event
in Q4 2023
ANB033 (anti-CD122 antagonist antibody)
- Presented poster on preclinical data for ANB033, an anti-CD122
antagonist for the treatment of inflammatory diseases, at the
Federation of Clinical Immunology Societies (FOCIS) Annual Meeting,
in June 2023
- Poster presentation is available here
- Plan to submit an Investigational New Drug (IND) application in
H1 2024
Updates on Legacy Clinical-Stage Cytokine Antagonist
Programs Available for Out-Licensing
- Completed enrollment of the GEMINI-1 Phase 3 trial for
imsidolimab (IL-36R) in GPP per the initial target enrollment
(n=45)
- Top-line data anticipated in Q4 2023
- Plan to out-license imsidolimab prior to potential FDA
approval
Updates on GSK Immuno-Oncology Financial
Collaboration
- GSK received U.S FDA approval for Jemperli (dostarlimab) in
combination with chemotherapy for the treatment of adult patients
with mismatch repair deficient (dMMR)/microsatellite
instability-high (MSI-H) primary advanced or recurrent endometrial
cancer on July 31, 2023
- Jemperli is the first immuno-oncology treatment approved in the
frontline setting for this patient population in combination with
chemotherapy
- GSK anticipates top-line data in H1 2024 from the FIRST Phase 3
trial for platinum-based therapy with dostarlimab and niraparib
versus platinum-based therapy as first-line treatment of Stage III
or IV nonmucinous epithelial ovarian cancer
- GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase
3 trial comparing cobolimab plus dostarlimab plus docetaxel to
dostarlimab plus docetaxel to docetaxel alone in patients with
advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy
and chemotherapy
Organizational Updates
- Announced appointment of Daniel Faga to the permanent position
of president and chief executive officer of the Company
- Mr. Faga will retain his position on the Company’s Board of
Directors
- Announced appointments of Luisa Salter-Cid, Ph.D., and Dolca
Thomas, M.D., to the Company's Scientific Advisory Board (SAB)
- Dr. Salter-Cid is the current chief scientific officer at
Pioneering Medicines, a strategic initiative within Flagship
Pioneering. She had extensive experience at Bristol-Meyers Squibb
where she led teams that advanced more than 20 compounds into
clinical development.
- Dr. Thomas is currently a venture partner at Samsara BioCapital
and serves on the Board of Directors of Allakos Therapeutics,
Chinook Therapeutics and Ventus Therapeutics. Dr. Thomas has
extensive experience in both large pharma and biotech. Among her
prior roles includes serving as Principia’s chief medical officer
from 2018 until the Sanofi acquisition in September 2020. Dr.
Thomas was also vice president and global head of Translational
Medicine for Immunology, Inflammation, and Infectious Disease at
Roche, where she was responsible for advancing multiple product
candidates through clinical development.
- Read their full bios here
Year-End Cash Guidance
- Reiterating cash runway through year-end 2026 with updated
expected year-end 2023 cash and investments of $380 – $395
million
Second Quarter Financial Results
- Cash, cash equivalents and investments totaled $488.7 million
as of June 30, 2023, compared to $584.2 million as of
December 31, 2022, for a decrease of $95.5 million. The
decrease relates primarily to cash used for the $50 million stock
repurchase program and operating activities.
- Collaboration revenue was $3.5 million and $4.8 million for the
three and six months ended June 30, 2023, compared to $1.2
million and $2.2 million for the three and six months ended June
30, 2022. The change is due primarily to increased royalties
recognized for sales of Jemperli.
- Research and development expenses were $32.9 million and $67.9
million for the three and six months ended June 30, 2023, compared
to $20.8 million and $43.4 million for the three and six months
ended June 30, 2022. The increase was due primarily to
manufacturing and development costs for imsidolimab, rosnilimab,
ANB032 and ANB033. The R&D non-cash, stock-based compensation
expense was $2.7 million and $5.5 million for the three and six
months ended June 30, 2023 as compared to $1.8 million and $3.4
million in the same period in 2022.
- General and administrative expenses were $10.7 million and
$21.5 million for the three and six months ended June 30, 2023,
compared to $8.2 million and $18.4 million for the three and six
months ended June 30, 2022. The G&A non-cash, stock-based
compensation expense was $5.7 million and $11.8 million for the
three and six months ended June 30, 2023 as compared to $4.9
million and $11.0 million in the same period in 2022.
- Net loss was $39.8 million and $84.1 million for the three and
six months ended June 30, 2023, or a net loss per share of $1.50
and $3.08, compared to a net loss of $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.
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, currently in a 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 trial in rheumatoid
arthritis and in a second indication; 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; timing of the
release of data from GSK’s clinical trials; 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 Communications AnaptysBio, Inc.
858.732.0178investors@anaptysbio.com
AnaptysBio, Inc.Consolidated Balance
Sheets(in thousands, except par value
data)(unaudited) |
|
|
June 30, 2023 |
|
December 31, 2022 |
|
|
|
|
|
ASSETS |
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
35,206 |
|
|
$ |
71,308 |
|
Receivables from collaborative
partners |
|
|
3,182 |
|
|
|
1,419 |
|
Short-term investments |
|
|
394,280 |
|
|
|
369,933 |
|
Prepaid expenses and other
current assets |
|
|
5,867 |
|
|
|
4,545 |
|
Total current assets |
|
|
438,535 |
|
|
|
447,205 |
|
Property and equipment,
net |
|
|
2,023 |
|
|
|
2,089 |
|
Operating lease right-of-use
assets |
|
|
17,047 |
|
|
|
17,898 |
|
Long-term investments |
|
|
59,239 |
|
|
|
142,935 |
|
Other long-term assets |
|
|
256 |
|
|
|
256 |
|
Total assets |
|
$ |
517,100 |
|
|
$ |
610,383 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
4,761 |
|
|
$ |
2,784 |
|
Accrued expenses |
|
|
35,164 |
|
|
|
21,633 |
|
Current portion of operating
lease liability |
|
|
1,706 |
|
|
|
1,637 |
|
Total current liabilities |
|
|
41,631 |
|
|
|
26,054 |
|
Liability related to sale of
future royalties |
|
|
310,073 |
|
|
|
304,413 |
|
Operating lease liability, net
of current portion |
|
|
16,946 |
|
|
|
17,813 |
|
Stockholders’ equity: |
|
|
|
|
Preferred stock, $0.001 par
value, 10,000 shares authorized and no shares, issued or
outstanding at June 30, 2023 and December 31, 2022,
respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par
value, 500,000 shares authorized, 26,531 shares and 28,513 shares
issued and outstanding at June 30, 2023 and December 31,
2022, respectively |
|
|
27 |
|
|
|
29 |
|
Additional paid in
capital |
|
|
686,611 |
|
|
|
717,797 |
|
Accumulated other
comprehensive loss |
|
|
(3,611 |
) |
|
|
(5,246 |
) |
Accumulated deficit |
|
|
(534,577 |
) |
|
|
(450,477 |
) |
Total stockholders’ equity |
|
|
148,450 |
|
|
|
262,103 |
|
Total liabilities and stockholders’ equity |
|
$ |
517,100 |
|
|
$ |
610,383 |
|
AnaptysBio, Inc.Consolidated Statements of
Operations and Comprehensive Loss(in thousands, except per
share data)(unaudited) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
|
$ |
3,460 |
|
|
$ |
1,216 |
|
|
$ |
4,834 |
|
|
$ |
2,186 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
32,923 |
|
|
|
20,844 |
|
|
|
67,880 |
|
|
|
43,360 |
|
General and administrative |
|
|
10,680 |
|
|
|
8,171 |
|
|
|
21,498 |
|
|
|
18,374 |
|
Total operating expenses |
|
|
43,603 |
|
|
|
29,015 |
|
|
|
89,378 |
|
|
|
61,734 |
|
Loss from operations |
|
|
(40,143 |
) |
|
|
(27,799 |
) |
|
|
(84,544 |
) |
|
|
(59,548 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
Interest income |
|
|
4,653 |
|
|
|
1,107 |
|
|
|
9,139 |
|
|
|
1,449 |
|
Non-cash interest expense for the sale of future royalties |
|
|
(4,358 |
) |
|
|
(5,868 |
) |
|
|
(8,694 |
) |
|
|
(10,722 |
) |
Other income (expense), net |
|
|
3 |
|
|
|
6 |
|
|
|
(1 |
) |
|
|
12 |
|
Total other income (expense), net |
|
|
298 |
|
|
|
(4,755 |
) |
|
|
444 |
|
|
|
(9,261 |
) |
Net loss |
|
|
(39,845 |
) |
|
|
(32,554 |
) |
|
|
(84,100 |
) |
|
|
(68,809 |
) |
Unrealized (loss) gain on available for sale securities |
|
|
(344 |
) |
|
|
(1,427 |
) |
|
|
1,635 |
|
|
|
(3,439 |
) |
Comprehensive loss |
|
$ |
(40,189 |
) |
|
$ |
(33,981 |
) |
|
$ |
(82,465 |
) |
|
$ |
(72,248 |
) |
Net loss per common share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(1.50 |
) |
|
$ |
(1.15 |
) |
|
$ |
(3.08 |
) |
|
$ |
(2.46 |
) |
Weighted-average number of shares outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
26,629 |
|
|
|
28,204 |
|
|
|
27,288 |
|
|
|
27,960 |
|
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