AnaptysBio Announces Third Quarter 2021 Financial Results and Provides Pipeline Updates
November 04 2021 - 4:05PM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage
biotechnology company developing first-in-class antibody product
candidates focused on emerging immune control mechanisms applicable
to inflammation and immuno-oncology indications, today reported
operating results for the third quarter ended September 30, 2021
and provided pipeline updates.
“Our wholly-owned pipeline continues to make progress with the
recent initiation of our imsidolimab GEMINI-1 Phase 3 trial in GPP
and anticipated initiation of our rosnilimab AZURE alopecia areata
Phase 2 trial during the remainder of 2021,” said Hamza Suria,
president and chief executive officer of AnaptysBio. “We believe
the recent royalty monetization transaction with Sagard validates
the future revenue stream anticipated from JEMPERLI sales and
further supports AnaptysBio’s capital-efficient business
model.”
Imsidolimab (Anti-IL-36 Receptor) Program
- Following an end-of-Phase 2 meeting
with the FDA in Q2 2021, we publicly disclosed Phase 3 trial
designs for imsidolimab in generalized pustular psoriasis (GPP),
GEMINI-1 and GEMINI-2. The primary endpoint of our GEMINI-1 Phase 3
trial is the proportion of patients achieving a score of clear (0)
or almost clear (1) skin on the Generalized Pustular Psoriasis
Physician’s Global Assessment (GPPPGA) at week 4 in 45 patients
randomized against placebo. GEMINI-2 will assess 6 months of
monthly subcutaneous dosing and safety follow-up of those same
patients. GEMINI-1 was initiated in Q3 2021.
- Full data from the Phase 2 GALLOP
trial in GPP, including efficacy and safety of imsidolimab
treatment through week 16, was disclosed in an oral presentation by
Dr. Johann Gudjonsson, professor of Dermatology at the University
of Michigan, at the European Academy of Dermatology and Venereology
(EADV) Congress on October 2nd, 2021. Imsidolimab demonstrated
rapid and sustained efficacy with 6 of 8 (75%) GPP patients
achieving the primary endpoint at week 4 and 16. We also observed
early reduction of erythema with pustules by 60% at week 1, 94%
reduction at week 4, 98% reduction at week 16, each versus
baseline.
- We anticipate top-line data from the
ACORN Phase 2 trial of imsidolimab in moderate-to-severe acne in H1
2022 and from the HARP Phase 2 trial in moderate-to-severe
hidradenitis suppurativa in H2 2022.
Rosnilimab (Anti-PD-1 Agonist) Program
- We anticipate top-line data in Q4 2021
from our ongoing Phase 1 healthy volunteer trial of rosnilimab, our
wholly-owned PD-1 agonist antibody, designed to assess the safety,
pharmacokinetics and pharmacodynamics of rosnilimab in single and
multiple ascending dose cohorts.
- We plan to initiate a randomized,
placebo-controlled Phase 2 clinical trial of rosnilimab in alopecia
areata in Q4 2021.
ANB032 (Anti-BTLA Modulator) Program
- We are advancing ANB032, our
wholly-owned BTLA modulator antibody, in a healthy volunteer Phase
1 single and multiple ascending dose clinical trial where top-line
data is anticipated during the first half of 2022.
GSK Partnered Programs
- JEMPERLI (dostarlimab), our
proprietary anti-PD-1 antagonist antibody under an immune-oncology
partnership with GSK, was approved in a second clinical indication
by the FDA in August 2021 for the treatment of pan-deficient
mismatch repair tumors. We received $20 million from GSK upon this
approval.
- We announced the signing of a royalty
monetization agreement with Sagard Healthcare Royalty Partners
where AnaptysBio will receive a $250 million payment upon closing
in exchange for JEMPERLI royalties due to AnaptysBio on annual
commercial sales below $1 billion and certain future milestones
starting October 2021. The aggregate JEMPERLI royalties and
milestones to be received by Sagard under this Agreement is capped
at certain fixed multiples of the upfront payment. The closing of
the transaction is subject to the satisfaction of customary closing
conditions and is anticipated by year-end 2021.
Third Quarter Financial Results
- Cash, cash equivalents and investments
totaled $389.3 million as of September 30, 2021, compared to
$411.2 million as of December 31, 2020, for a decrease of
$21.9 million. The decrease relates primarily to cash used for
operating activities.
- Collaboration revenue was $20.9
million and $62.2 million for the three and nine months ended
September 30, 2021. The $20.9 million earned during the third
quarter primarily relates to milestone and royalty revenue for the
US approval of JEMPERLI (dostarlimab), compared to zero and $15.0
million of milestone revenue for the three and nine months ended
September 30, 2020.
- Research and development expenses were
$22.2 million and $71.7 million for the three and nine months ended
September 30, 2021, compared to $19.5 million and $58.5
million for the three and nine months ended September 30,
2020. The increase was due primarily to continued advancement of
the Company’s clinical programs.
- General and administrative expenses
were $5.4 million and $16.1 million for the three and nine months
ended September 30, 2021, compared to $4.8 million and $13.8
million for the three and nine months ended September 30,
2020. The increase was due primarily to personnel-related expenses,
including share-based compensation.
- Net loss was $6.7 million and $25.3
million for the three and nine months ended September 30,
2021, or a net loss per share of $0.24, and $0.92, compared to a
net loss of $23.8 million and $53.6 million for the three and nine
months ended September 30, 2020, or a net loss per share of
$0.87 and $1.96.
Financial Guidance
Following the anticipated closing of the Sagard royalty
monetization transaction by the end of 2021, we anticipate ending
2021 with approximately $600 million in cash and will continue to
operate in a capital-efficient manner.
About AnaptysBio
AnaptysBio 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 imsidolimab, its anti-IL-36R antibody, previously
referred to as ANB019, for the treatment of dermatological
inflammatory diseases, including generalized pustular psoriasis, or
GPP, acne, and hidradenitis suppurativa; rosnilimab, its anti-PD-1
agonist program, previously referred to as ANB030, for the
treatment of certain autoimmune diseases where immune checkpoint
receptors are insufficiently activated; and its BTLA modulator
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), and an inflammation
collaboration with Bristol-Myers Squibb, including an anti-PD-1
checkpoint agonist antibody (CC-90006) currently in clinical
development.
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 2 clinical trials in acne,
and hidradenitis suppurativa, rosnilimab’s Phase 1 healthy
volunteer clinical trial and Phase 2 clinical trial in alopecia
areata, and ANB032’s healthy volunteer Phase 1 trial; the timing of
the initiation of imsidolimab’s GPP Phase 3 clinical trials;
including the risk that the transaction with Sagard may not close
when expected, or at all, the risk that commercial sales of
JEMPERLI may not reach expected levels, under the GSK
collaboration; and our projected 2021 cash burn and 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 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)
|
September 30, 2021 |
|
December 31, 2020 |
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
336,328 |
|
|
$ |
250,456 |
|
Receivables from collaborative
partners |
761 |
|
|
— |
|
Short-term investments |
37,736 |
|
|
143,197 |
|
Prepaid expenses and other
current assets |
11,759 |
|
|
2,908 |
|
Short-term restricted cash |
60 |
|
|
— |
|
Total current assets |
386,644 |
|
|
396,561 |
|
Property and equipment, net |
2,413 |
|
|
1,783 |
|
Operating lease right-of-use
assets |
19,778 |
|
|
344 |
|
Long-term investments |
15,242 |
|
|
17,546 |
|
Other long-term assets |
258 |
|
|
258 |
|
Long-term restricted cash |
— |
|
|
60 |
|
Total assets |
$ |
424,335 |
|
|
$ |
416,552 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
5,717 |
|
|
$ |
4,217 |
|
Accrued expenses |
14,075 |
|
|
15,262 |
|
Current portion of operating
lease liability |
1,097 |
|
|
342 |
|
Total current liabilities |
20,889 |
|
|
19,821 |
|
Operating lease liability, net of
current portion |
19,838 |
|
|
— |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par
value, 10,000 shares authorized and no shares, issued or
outstanding at September 30, 2021 and December 31, 2020,
respectively |
— |
|
|
— |
|
Common stock, $0.001 par
value, 500,000 shares authorized, 27,454 shares and 27,356 shares
issued and outstanding at September 30, 2021 and December 31, 2020,
respectively |
27 |
|
|
27 |
|
Additional paid in capital |
672,996 |
|
|
660,665 |
|
Accumulated other comprehensive
loss |
(200 |
) |
|
(4 |
) |
Accumulated deficit |
(289,215 |
) |
|
(263,957 |
) |
Total stockholders’ equity |
383,608 |
|
|
396,731 |
|
Total liabilities and stockholders’ equity |
$ |
424,335 |
|
|
$ |
416,552 |
|
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, |
|
2021 |
|
2020 |
|
2021 |
2020 |
Collaboration revenue |
$ |
20,890 |
|
|
$ |
— |
|
|
$ |
62,164 |
|
|
$ |
15,000 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
22,221 |
|
|
19,542 |
|
|
71,720 |
|
|
58,458 |
|
General and administrative |
5,432 |
|
|
4,794 |
|
|
16,101 |
|
|
13,766 |
|
Total operating expenses |
27,653 |
|
|
24,336 |
|
|
87,821 |
|
|
72,224 |
|
Loss from operations |
(6,763 |
) |
|
(24,336 |
) |
|
(25,657 |
) |
|
(57,224 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
Interest income |
64 |
|
|
625 |
|
|
363 |
|
|
3,583 |
|
Other income (expense), net |
33 |
|
|
(56 |
) |
|
36 |
|
|
64 |
|
Total other income, net |
97 |
|
|
569 |
|
|
399 |
|
|
3,647 |
|
Net loss |
(6,666 |
) |
|
(23,767 |
) |
|
(25,258 |
) |
|
(53,577 |
) |
Unrealized loss on available for sale securities |
(24 |
) |
|
(494 |
) |
|
(196 |
) |
|
(79 |
) |
Comprehensive loss |
$ |
(6,690 |
) |
|
$ |
(24,261 |
) |
|
$ |
(25,454 |
) |
|
$ |
(53,656 |
) |
Net loss per common share: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.24 |
) |
|
$ |
(0.87 |
) |
|
$ |
(0.92 |
) |
|
$ |
(1.96 |
) |
Weighted-average number of shares outstanding: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
27,436 |
|
|
27,316 |
|
|
27,397 |
|
|
27,286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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