AnaptysBio Announces First Quarter 2021 Financial Results and Provides Pipeline Updates
May 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 first quarter ended March 31, 2021 and
provided pipeline updates.
“We look forward to advancing imsidolimab into a Phase 3
trial for GPP following our recent end-of-Phase 2 meeting with the
FDA,” said Hamza Suria, president and chief executive officer of
AnaptysBio. “AnaptysBio continues to pursue a capital-efficient
business model where partnership revenues continue to support
advancement of our wholly-owned pipeline poised to generate
multiple clinical data catalysts through 2021 and 2022.”
Imsidolimab (Anti-IL-36 Receptor) Program
- We held an end-of-Phase 2 meeting with
the FDA during Q2 2021 to review an orphan disease Phase 3
development plan for imsidolimab for the treatment of GPP and
anticipate announcing key aspects of our Phase 3 trial design upon
its initiation in mid-2021. Our worldwide registry of GPP patients,
named RADIANCE, is ongoing, and we expect that this study will
improve our understanding of the patient journey and support
enrollment of our Phase 3 clinical trial. While initial GPP
epidemiology studies suggested at least 3,000 GPP patients in the
United States, medical claims analyses conducted by IQVIA indicate
approximately 37,000 unique patients were diagnosed with GPP at
least once, and approximately 15,000 unique patients were diagnosed
with GPP at least twice, by a physician between 2017 and 2019 using
the International Classification of Diseases 10th Revision (ICD-10)
billing code pertaining to GPP (L40.1).
- We initiated a Phase 2 clinical trial
of imsidolimab in hidradenitis suppurativa, named HARP, where
120-patients are randomized equally between two dose levels of
imsidolimab and placebo, and top-line data is anticipated in H2
2022. We also commenced an imsidolimab Phase 2 trial in
moderate-to-severe acne, named ACORN, where 120-patients are
randomized equally between two dose levels of imsidolimab and
placebo, and top-line data is anticipated in H1 2022. We continue
to anticipate top-line data at the end of 2021 from our EMERGE
Phase 2 trial of imsidolimab in EGFR/MEK-mediated skin toxicities
and top-line data from our Phase 2 INSPIRE trial in ichthyosis
during 2022.
- We announced in Q1 2021 top-line data
from our POPLAR phase 2 clinical trial of imsidolimab monotherapy
in PPP, which failed to meet the trial’s primary endpoint. While we
continue to review secondary endpoints to further understand the
activity of imsidolimab in various PPP patient subsets, we do not
currently plan to pursue further clinical development of
imsidolimab in PPP.
ANB030 (Anti-PD-1 Agonist) Program
- We anticipate top-line data in H2 2021
from our ongoing Phase 1 healthy volunteer clinical trial of
ANB030, our wholly-owned PD-1 agonist antibody, designed to assess
the safety, pharmacokinetics and pharmacodynamics of ANB030 in
single and multiple ascending dose cohorts.
- We plan to initiate Phase 2 clinical
trials of ANB030 in alopecia areata and vitiligo in Q4 2021.
- Preclinical translational data using
ANB030 was presented in March 2020 at the Festival of Biologics
Meeting.
ANB032 (Anti-BTLA Modulator) Program
- We achieved first-in-human dosing of
ANB032, our wholly-owned BTLA modulator antibody, upon initiation
of a healthy volunteer Phase 1 trial in the first quarter of 2021,
under an Australian Clinical Trial Notification (CTN), and
anticipate top-line data from this trial during the first half of
2022.
- We presented preclinical data
regarding ANB032 at the 2020 Federation of Clinical Immunology
Societies (FOCIS) Virtual Annual Meeting in October 2020.
GSK Partnered Programs
- A BLA for our most advanced partnered
program, which is an anti-PD-1 antagonist antibody called JEMPERLI
(dostarlimab), was approved by the FDA in April 2021 for the
treatment of advanced or recurrent deficient mismatch repair
endometrial cancer (dMMREC). This is the first AnaptysBio-generated
antibody, of eight currently under clinical development, to obtain
FDA approval. We earned a $20.0 million milestone payment as a
result of this FDA approval.
- In April 2021 the European Medicines
Agency (EMA) granted conditional marketing authorization in the
European Union for JEMPERLI for use in women with mismatch repair
deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent
or advanced endometrial cancer who have progressed on or following
prior treatment with a platinum containing regimen, which approval
makes JEMPERLI the first anti-PD-1 therapy available for
endometrial cancer in Europe. We earned a $10.0 million milestone
payment as a result of this approval.
- A second BLA submitted by GSK was
accepted by the FDA during the first quarter of 2021 for JEMPERLI
in pan-deficient mismatch repair tumors (PdMMRT). We received a
$10.0 million cash milestone payment upon the FDA acceptance of
GSK’s second FDA BLA for JEMPERLI and anticipate an additional
$20.0 million cash milestone payment upon FDA approval of this
second FDA BLA of JEMPERLI during the second half of 2021. We
anticipate an additional $15.0 million and $165.0 million in
milestone payments upon achievement of certain JEMPERLI regulatory
and commercial milestones, respectively.
- During Q1 2021, we recognized $1.2
million in royalty revenue related to GSK’s Zejula product sales,
which we estimated based on GSK’s historical sales. In October
2020, we amended our GSK collaboration which resulted in increased
royalties on global net sales of JEMPERLI to 8-25%, a 1% royalty
rate on GSK’s global net sales of Zejula and a one-time cash
payment of $60.0 million.
First Quarter Financial Results
- Cash, cash equivalents and investments
totaled $387.4 million as of March 31, 2021 compared to $411.2
million as of December 31, 2020, for a decrease of $23.8
million. The decrease relates primarily to cash used for operating
activities.
- Collaboration revenue was $11.2
million for the three months ended March 31, 2021, $10.0
million related to milestone revenue for the FDA accepted BLA
filing of the second dostarlimab indication and $1.2 million
related to royalties on GSK’s Zejula product sales, compared to
$15.0 million of milestone revenue for the three months ended
March 31, 2020.
- Research and development expenses were
$24.2 million for the three months ended March 31, 2021,
compared to $21.0 million for the three months ended March 31,
2020. The increase was due primarily to continued advancement of
the Company’s clinical programs.
- General and administrative expenses
were $5.4 million for the three months ended March 31, 2021,
compared to $4.3 million for the three months ended March 31,
2020. The increase was due primarily to personnel-related expenses,
including share-based compensation.
- Net loss was $18.2 million for the
three months ended March 31, 2021, or a net loss per share of
$0.66, compared to a net loss of $8.3 million for the three months
ended March 31, 2020, or a net loss per share of $0.30.
Financial Guidance
AnaptysBio expects its net cash burn in 2021 will be close to
$100 million. We anticipate that our cash, cash equivalents and
anticipated revenues will fund our current operating plan at least
into 2024.
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, EGFRi skin toxicity, ichthyosis, hidradenitis suppurativa and
acne; its anti-PD-1 agonist program, ANB030, for 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)), 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 EGFRi,
ichthyosis, hidradenitis suppurativa and acne, ANB030’s Phase 2
clinical trials in alopecia areata and vitiligo, and ANB032’s
healthy volunteer Phase 1 trial; the timing of announcement of key
aspects of imsidolimab’s GPP Phase 3 clinical trial design and
initiation of the trial; the milestones and royalty payments to be
received 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)
|
March 31, 2021 |
|
December 31, 2020 |
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
284,148 |
|
|
$ |
250,456 |
|
Receivable from collaborative
partners |
1,247 |
|
|
— |
|
Short-term investments |
96,212 |
|
|
143,197 |
|
Prepaid expenses and other
current assets |
5,464 |
|
|
2,908 |
|
Restricted cash |
60 |
|
|
— |
|
Total current assets |
387,131 |
|
|
396,561 |
|
Property and equipment, net |
1,754 |
|
|
1,783 |
|
Long-term investments |
7,056 |
|
|
17,546 |
|
Other long-term assets |
477 |
|
|
602 |
|
Restricted cash |
— |
|
|
60 |
|
Total assets |
$ |
396,418 |
|
|
$ |
416,552 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,452 |
|
|
$ |
4,217 |
|
Accrued expenses |
11,826 |
|
|
15,262 |
|
Other current liabilities |
197 |
|
|
342 |
|
Total current liabilities |
14,475 |
|
|
19,821 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par
value, 10,000 shares authorized and no shares, issued or
outstanding at March 31, 2021 and December 31, 2020,
respectively |
— |
|
|
— |
|
Common stock, $0.001 par
value, 500,000 shares authorized, 27,367 shares and 27,356 shares
issued and outstanding at March 31, 2021 and December 31, 2020,
respectively |
27 |
|
|
27 |
|
Additional paid in capital |
664,147 |
|
|
660,665 |
|
Accumulated other comprehensive
loss |
(111 |
) |
|
(4 |
) |
Accumulated deficit |
(282,120 |
) |
|
(263,957 |
) |
Total stockholders’ equity |
381,943 |
|
|
396,731 |
|
Total liabilities and stockholders’ equity |
$ |
396,418 |
|
|
$ |
416,552 |
|
AnaptysBio,
Inc.Consolidated Statements of Operations and
Comprehensive Loss(in thousands, except per share
data)(unaudited)
|
Three Months EndedMarch 31, |
|
2021 |
|
2020 |
Collaboration revenue |
$ |
11,247 |
|
|
$ |
15,000 |
|
Operating expenses: |
|
|
|
Research and development |
24,185 |
|
|
20,968 |
|
General and administrative |
5,423 |
|
|
4,285 |
|
Total operating expenses |
29,608 |
|
|
25,253 |
|
Loss from operations |
(18,361 |
) |
|
(10,253 |
) |
Other income, net: |
|
|
|
Interest income |
195 |
|
|
1,897 |
|
Other income, net |
3 |
|
|
94 |
|
Total other income, net |
198 |
|
|
1,991 |
|
Net loss |
(18,163 |
) |
|
(8,262 |
) |
Unrealized (loss) income on available for sale securities |
(107 |
) |
|
807 |
|
Comprehensive loss |
$ |
(18,270 |
) |
|
$ |
(7,455 |
) |
Net loss per common share: |
|
|
|
Basic and diluted |
$ |
(0.66 |
) |
|
$ |
(0.30 |
) |
Weighted-average number of shares
outstanding: |
|
|
|
Basic and diluted |
27,361 |
|
|
27,264 |
|
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