AnaptysBio Announces Second Quarter 2021 Financial Results and Provides Pipeline Updates
10 August 2021 - 6:05AM
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 second quarter ended June 30, 2021 and
provided pipeline updates.
“We continue to make progress in advancing our wholly-owned
pipeline and look forward to multiple clinical data readouts over
the upcoming 18 months,” said Hamza Suria, president and chief
executive officer of AnaptysBio. “The recent approval of JEMPERLI,
which is the first AnaptysBio-generated antibody to be approved in
the US and EU, validates AnaptysBio’s antibody discovery platform
and provides additional revenues to support our capital-efficient
business model.”
Imsidolimab (Anti-IL-36 Receptor) Program
- Following an end-of-Phase 2 meeting
with the FDA in Q2, we publicly disclosed trial designs for our
imsidolimab generalized pustular psoriasis (GPP) Phase 3 trials,
called GEMINI-1 and GEMINI-2. We anticipate initiating
GEMINI-1 in Q3 2021. The primary endpoint of our Phase
3 program is the proportion of patients achieving clear or almost
clear skin as determined by a Generalized Pustular Psoriasis
Physician’s Global Assessment (GPPPGA) score of zero or 1 at week 4
of GEMINI-1, while GEMINI-2 is designed for 6 months of safety
follow-up assessment.
- We continue to enroll GPP patients in
our worldwide registry of GPP patients, called RADIANCE, which is
designed to improve our understanding of GPP patient journeys and
support enrollment of our GEMINI Phase 3 trials.
Medical claims analyses recently 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, in the United States by a physician
between 2017 and 2019 using the International Classification of
Diseases 10th Revision (ICD-10) billing code pertaining to GPP
(L40.1).
- Full data from our completed Phase 2
GALLOP trial of imsidolimab in GPP, including efficacy and safety
of imsidolimab treatment through week 16, will be disclosed in an
oral presentation at the European Academy of Dermatology and
Venereology (EADV) Congress on October 2nd, 2021.
- We are continuing to advance
imsidolimab through Phase 2 clinical trials in multiple additional
indications associated with IL-36 signaling
dysfunction. Our 120-patient placebo-controlled ACORN
Phase 2 trial of imsidolimab in moderate-to-severe acne is
anticipated to read out top-line data in the first half of
2022. Imsidolimab is also being tested versus placebo
in hidradenitis suppurativa, where our 120-patient HARP trial is
anticipated to generate top-line data in the second half of 2022.
We continue to enroll our 45-patient placebo-controlled EMERGE
Phase 2 trial of imsidolimab in EGFR/MEK-mediated skin toxicities,
where we anticipate an interim analysis by the end of
2021. We also continue to enroll patients in our
INSPIRE Phase 2 trial in ichthyosis where top-line data is
anticipated during 2022.
Rosnilimab (Anti-PD-1 Agonist) Program
- We anticipate top-line data in Q4 2021
from our ongoing Phase 1 healthy volunteer clinical 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
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, was approved by the FDA
and the European Medicines Agency (EMA) during April 2021 for
treatment of advanced or recurrent mismatch repair deficient
endometrial cancer. This is the first
AnaptysBio-generated antibody, of eight currently under clinical
development, to obtain regulatory approval. GSK has recently
disclosed peak annual sales estimates of £1-£2 billion for
JEMPERLI, and AnaptysBio will earn 8-25% royalties on global net
sales of JEMPERLI. We received $20 million and $10 million
milestone payments upon FDA and EMA approval of JEMPERLI,
respectively. We anticipate earning an additional $20
million milestone payment upon a second FDA BLA approval for
JEMPERLI in pan-deficient mismatch repair tumors during the second
half of 2021. AnaptysBio is due an additional $15
million and $165 million upon certain JEMPERLI regulatory and
commercial milestones, respectively.
Second Quarter Financial Results
- Cash, cash equivalents and investments
totaled $396.3 million as of June 30, 2021, compared to $411.2
million as of December 31, 2020, for a decrease of $14.9
million. The decrease relates primarily to cash used for operating
activities.
- Collaboration revenue was $30 million
and $41.3 million for the three and six months ended June 30,
2021. The $30 million earned during the second quarter relates to
milestone revenue for the US and EU approval of JEMPERLI
(dostarlimab), compared to zero and $15 million of milestone
revenue for the three and six months ended June 30, 2020.
- Research and development expenses were
$25.3 million and $49.5 million for the three and six months ended
June 30, 2021, compared to $17.9 million and $38.9 million for
the three and six months ended June 30, 2020. The increase was
due primarily to continued advancement of the Company’s clinical
programs.
- General and administrative expenses
were $5.2 million and $10.7 million for the three and six months
ended June 30, 2021, compared to $4.7 million and $9 million
for the three and six months ended June 30, 2020. The increase
was due primarily to personnel-related expenses, including
share-based compensation.
- Net loss was $0.4 million and $18.6
million for the three and six months ended June 30, 2021, or a
net loss per share of $0.02, and $0.68, compared to a net loss of
$21.5 million and $29.8 million for the three and six months ended
June 30, 2020, or a net loss per share of $0.79 and
$1.09.
Financial Guidance
AnaptysBio expects its net cash burn in 2021 will be less than
$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, acne, hidradenitis suppurativa, EGFRi skin toxicity and
ichthyosis; its anti-PD-1 agonist program, rosnilimab, 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 acne,
hidradenitis suppurativa, EGFRi and ichthyosis, 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; 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)
|
June 30, 2021 |
|
December 31, 2020 |
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
332,254 |
|
|
|
$ |
250,456 |
|
|
Receivable from collaborative
partners |
642 |
|
|
|
— |
|
|
Short-term investments |
58,597 |
|
|
|
143,197 |
|
|
Prepaid expenses and other
current assets |
6,508 |
|
|
|
2,908 |
|
|
Restricted cash |
60 |
|
|
|
— |
|
|
Total current assets |
398,061 |
|
|
|
396,561 |
|
|
Property and equipment, net |
2,488 |
|
|
|
1,783 |
|
|
Operating lease right-of-use
assets |
20,278 |
|
|
|
344 |
|
|
Long-term investments |
5,484 |
|
|
|
17,546 |
|
|
Other long-term assets |
258 |
|
|
|
258 |
|
|
Restricted cash |
— |
|
|
|
60 |
|
|
Total assets |
$ |
426,569 |
|
|
|
$ |
416,552 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
4,103 |
|
|
|
$ |
4,217 |
|
|
Accrued expenses |
15,958 |
|
|
|
15,262 |
|
|
Current portion of operating
lease liability |
555 |
|
|
|
342 |
|
|
Total current liabilities |
20,616 |
|
|
|
19,821 |
|
|
Operating lease liability, net of
current portion |
20,222 |
|
|
|
— |
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par
value, 10,000 shares authorized and no shares, issued or
outstanding at June 30, 2021 and December 31, 2020,
respectively |
— |
|
|
|
— |
|
|
Common stock, $0.001 par
value, 500,000 shares authorized, 27,433 shares and 27,356 shares
issued and outstanding at June 30, 2021 and December 31, 2020,
respectively |
27 |
|
|
|
27 |
|
|
Additional paid in capital |
668,429 |
|
|
|
660,665 |
|
|
Accumulated other comprehensive
loss |
(176 |
) |
|
|
(4 |
) |
|
Accumulated deficit |
(282,549 |
) |
|
|
(263,957 |
) |
|
Total stockholders’ equity |
385,731 |
|
|
|
396,731 |
|
|
Total liabilities and stockholders’ equity |
$ |
426,569 |
|
|
|
$ |
416,552 |
|
|
AnaptysBio, Inc.
Consolidated Statements of Operations and Comprehensive
Loss(in thousands, except per share data)
(unaudited)
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Collaboration revenue |
$ |
30,027 |
|
|
|
$ |
— |
|
|
|
$ |
41,274 |
|
|
|
$ |
15,000 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
25,314 |
|
|
|
17,948 |
|
|
|
49,499 |
|
|
|
38,916 |
|
|
General and administrative |
5,246 |
|
|
|
4,687 |
|
|
|
10,669 |
|
|
|
8,972 |
|
|
Total operating expenses |
30,560 |
|
|
|
22,635 |
|
|
|
60,168 |
|
|
|
47,888 |
|
|
Loss from operations |
(533 |
) |
|
|
(22,635 |
) |
|
|
(18,894 |
) |
|
|
(32,888 |
) |
|
Other income, net: |
|
|
|
|
|
|
|
Interest income |
104 |
|
|
|
1,061 |
|
|
|
299 |
|
|
|
2,958 |
|
|
Other income, net |
— |
|
|
|
26 |
|
|
|
3 |
|
|
|
120 |
|
|
Total other income, net |
104 |
|
|
|
1,087 |
|
|
|
302 |
|
|
|
3,078 |
|
|
Net loss |
(429 |
) |
|
|
(21,548 |
) |
|
|
(18,592 |
) |
|
|
(29,810 |
) |
|
Unrealized (loss) income on available for sale securities |
(65 |
) |
|
|
(392 |
) |
|
|
(172 |
) |
|
|
415 |
|
|
Comprehensive loss |
$ |
(494 |
) |
|
|
$ |
(21,940 |
) |
|
|
$ |
(18,764 |
) |
|
|
$ |
(29,395 |
) |
|
Net loss per common share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.02 |
) |
|
|
$ |
(0.79 |
) |
|
|
$ |
(0.68 |
) |
|
|
$ |
(1.09 |
) |
|
Weighted-average number of shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
27,391 |
|
|
|
27,279 |
|
|
|
27,377 |
|
|
|
27,271 |
|
|
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