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, 2020
and provided pipeline updates.
“We are excited with the recent interim results from our GALLOP
trial and look forward to engaging with regulatory authorities to
progress imsidolimab into registration trials for the treatment of
GPP,” said Hamza Suria, president and chief executive officer of
AnaptysBio. “Under our amended immuno-oncology collaboration with
GSK, we look forward to the anticipated first FDA approval of
dostarlimab and its advancement for patients suffering with various
oncological disorders.”
Imsidolimab (Anti-IL-36 Receptor) Program
- In July, we announced that the U.S. Food and Drug
Administration (FDA) has granted orphan drug designation for
imsidolimab, our proprietary anti-interleukin-36 receptor (IL-36R)
antibody, for the treatment of patients with GPP. Treatment
of GPP by imsidolimab is being evaluated in the GALLOP Phase 2
trial.
- Patients demonstrated rapid onset, overall safety and promising
efficacy upon imsidolimab monotherapy in a Day 29 interim analysis
of our GALLOP Phase 2 GPP trial. Six of 8 patients achieved
the primary endpoint of disease improvement upon Day 29, while
erythema with skin pustules, which clinically defines GPP,
decreased by 94% on Day 29 relative to baseline.
- An end-of-Phase 2 meeting, based upon data available from the 8
patients enrolled in the GALLOP trial, is anticipated in Q4
2020.
- We are also conducting a randomized, placebo-controlled,
multi-dose Phase 2 trial in approximately 50 patients with
palmoplantar pustulosis, or PPP, also known as the POPLAR trial,
which is now fully enrolled with topline data anticipated in Q1
2021.
- We anticipate expanding the imsidolimab program in two new
indications, EGFR-mediated skin toxicities and ichthyosis, based
upon human translational data that suggests each of these
conditions are mediated by dysregulated signaling through the IL-36
pathway. Initiation of Phase 2 trials for each of these
indications is anticipated in Q4 2020.
- Worldwide registry of GPP and PPP patients, named RADIANCE, to
be initiated in Q1 2021, to improve understanding of the patient
journey and support enrollment of future trials.
ANB030 (Anti-PD-1 Agonist) Program
- We anticipate topline data 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 in mid-2021. Preclinical translational data using
ANB030 was presented in March 2020 at the Festival of Biologics
Meeting.
ANB032 (Anti-BTLA Modulator) Program
- We anticipate filing an investigational new drug application
(IND) for ANB032, our wholly-owned BTLA modulator antibody, in Q4
2020. We presented preclinical data regarding ANB032 at the
2020 Federation of Clinical Immunology Societies (FOCIS) Virtual
Annual Meeting in October 2020.
Etokimab (ANB020 Anti-IL-33) Program
- In an interim analysis at week 8 of the ongoing ECLIPSE Phase 2
trial of etokimab in chronic rhinosinusitis with nasal polyps,
patients dosed with etokimab every four (q4w) or eight weeks (q8w)
failed to achieve statistically significant improvement in their
bilateral nasal polyps score (NPS), an endoscopic measure of nasal
occlusion, and their sino-nasal outcome test (SNOT-22), a patient
reported quality-of-life assessment, versus placebo at the week 8
timepoint. Both endpoints demonstrated statistically
significant improvement over baseline levels of NPS and
SNOT-22. Blood eosinophil levels, which are a biomarker of
etokimab’s mechanism, demonstrated statistically significant
reduction relative to baseline in both etokimab treatment
arms. We intend to decide on a path forward for the etokimab
program after reviewing week 16 primary endpoint data by year-end
2020.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with
GSK
- In October 2020, we amended our immuno-oncology collaboration
with GSK resulting in increased financial consideration to
AnaptysBio. Royalties due to AnaptysBio for dostarlimab were
increased to 8-25% of global net sales, where AnaptysBio will
receive 8% of annual global net sales below $1 billion, and 12-25%
of net sales above $1 billion. The $1.1 billion in cash milestone
payments due under the collaboration agreement remain unchanged,
and AnaptysBio anticipates receiving $75 million in such cash
milestones over the next 18 months as dostarlimab obtains FDA and
EMA regulatory approval for the first two indications. An
additional $165 million in sales milestones is anticipated by
AnaptysBio upon achievement of certain dostarlimab annual sales
revenues. GSK has also agreed, starting January 1, 2021, to pay
AnaptysBio a 1% royalty on all of GSK’s global net sales of
Zejula™. In addition, GSK has agreed to pay AnaptysBio a one-time
cash payment of $60 million within 30 days. In exchange,
AnaptysBio has provided GSK with freedom to conduct development and
commercialization of Zejula™ in combination with third-party
molecules and settled the ongoing legal dispute between AnaptysBio
and GSK.
Third Quarter Financial Results
Cash, cash equivalents and investments totaled $374.5 million as
of September 30, 2020 compared to $428.5 million as of December 31,
2019, for a decrease of $54.0 million. The decrease relates
primarily to cash used for operating activities.
Collaboration revenue was zero and $15.0 million for the three
and nine months ended September,30 2020, which related to milestone
payments for successful BLA and MAA filings for dostarlimab by GSK,
compared to zero and $5 million for the three and nine months ended
September 30, 2019.
Research and development expenses were $19.5 million and $58.5
million for the three and nine months ended September 30, 2020,
compared to $29.9 million and $77.9 million for the three and nine
months ended September 30, 2019. The decrease was due primarily to
reduced outside services for manufacturing and clinical expenses
based on the timing of projects.
General and administrative expenses were $4.8 million and $13.8
million for the three and nine months ended September 30, 2020,
compared to $3.8 million and $12.3 million for the three and nine
months ended September 30, 2019. The increase was due primarily to
increased legal and insurance expenses.
Net loss was $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, compared to a net loss of $31.0 million and $77.1
million for the three and nine months ended September 30, 2019, or
a net loss per share of $1.15 and $2.85.
Financial GuidanceAnaptysBio expects its net cash burn in 2020
will be close to breakeven assuming the $20 million milestone
payment upon first FDA approval of dostarlimab is received by
year-end. We anticipate that our cash, cash equivalents and
anticipated revenues will fund our current operating plan at least
into 2023.
About AnaptysBioAnaptysBio is 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. The Company’s
proprietary anti-inflammatory pipeline includes its anti-IL-36R
antibody imsidolimab, previously referred to as ANB019, for the
treatment of rare inflammatory diseases, including generalized
pustular psoriasis, or GPP, palmoplantar pustulosis, or PPP, EGFRi
and ichthyosis; its anti-PD-1 agonist program, ANB030, for
treatment of certain autoimmune diseases where immune checkpoint
receptors are insufficiently activated; its BTLA modulator program,
ANB032, which is broadly applicable to human inflammatory diseases
associated with lymphoid and myeloid immune cell dysregulation; and
its anti-IL-33 antibody etokimab, previously referred to as ANB020,
for the treatment of chronic rhinosinusitis with nasal polyps, or
CRSwNP, and eosinophilic asthma. 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
GlaxoSmithKline, including an anti-PD-1 antagonist antibody
(dostarlimab GSK4057190A), an anti-TIM-3 antagonist antibody
(cobolimab, GSK4069889A) 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 StatementsThis 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 trial in PPP; the timing of initiation of imsidolimab’s
Phase 2 clinical trials in EGFRi and ichthyosis; and etokimab’s
week 16 data for the ECLIPSE Phase 2 clinical trial in chronic
rhinosinusitis with nasal polyps; the timing of an end-of-Phase 2
meeting with the FDA for GPP; the timing of an IND filing for
ANB032; the milestones and royalty payments to be received under
the GSK collaboration; and our projected 2020 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)
|
September 30, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
|
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
209,154 |
|
|
$ |
171,017 |
|
Short-term investments |
129,192 |
|
|
203,210 |
|
Prepaid expenses and other
current assets |
7,468 |
|
|
3,506 |
|
Total current assets |
345,814 |
|
|
377,733 |
|
Property and equipment, net |
1,585 |
|
|
1,618 |
|
Long-term investments |
36,177 |
|
|
54,305 |
|
Other long-term assets |
1,114 |
|
|
1,481 |
|
Restricted cash |
60 |
|
|
60 |
|
Total assets |
$ |
384,750 |
|
|
$ |
435,197 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
5,484 |
|
|
$ |
16,237 |
|
Accrued expenses |
18,139 |
|
|
11,052 |
|
Notes payable, current
portion |
— |
|
|
1,375 |
|
Other current liabilities |
851 |
|
|
871 |
|
Total current liabilities |
24,474 |
|
|
29,535 |
|
Other long-term liabilities |
33 |
|
|
654 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value, 10,000 shares authorized and
no shares, issued or outstanding at September 30, 2020 and December
31, 2019, respectively |
— |
|
|
— |
|
Common stock, $0.001 par value, 500,000 shares authorized,
27,346 shares and 27,255 shares issued and outstanding at September
30, 2020 and December 31, 2019, respectively |
27 |
|
|
27 |
|
Additional paid-in capital |
657,560 |
|
|
648,669 |
|
Accumulated other comprehensive
income |
259 |
|
|
338 |
|
Accumulated deficit |
(297,603 |
) |
|
(244,026 |
) |
Total stockholders’ equity |
360,243 |
|
|
405,008 |
|
Total liabilities and stockholders’ equity |
$ |
384,750 |
|
|
$ |
435,197 |
|
|
|
|
|
|
|
|
|
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, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Collaboration revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
15,000 |
|
|
$ |
5,000 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
19,542 |
|
|
29,931 |
|
|
58,458 |
|
|
77,912 |
|
General and administrative |
4,794 |
|
|
3,814 |
|
|
13,766 |
|
|
12,262 |
|
Total operating expenses |
24,336 |
|
|
33,745 |
|
|
72,224 |
|
|
90,174 |
|
Loss from operations |
(24,336 |
) |
|
(33,745 |
) |
|
(57,224 |
) |
|
(85,174 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
Interest expense |
— |
|
|
(240 |
) |
|
— |
|
|
(841 |
) |
Interest income |
625 |
|
|
2,757 |
|
|
3,583 |
|
|
8,702 |
|
Other (expense) income, net |
(56 |
) |
|
144 |
|
|
64 |
|
|
110 |
|
Total other income (expense), net |
569 |
|
|
2,661 |
|
|
3,647 |
|
|
7,971 |
|
Loss before income taxes |
(23,767 |
) |
|
(31,084 |
) |
|
(53,577 |
) |
|
(77,203 |
) |
Provision for income taxes |
— |
|
|
51 |
|
|
— |
|
|
130 |
|
Net loss |
(23,767 |
) |
|
(31,033 |
) |
|
(53,577 |
) |
|
(77,073 |
) |
Other comprehensive (loss)
income: |
|
|
|
|
|
|
|
Unrealized (loss) income on available for sale securities, net of
tax of $0, ($25), $0 and $189, respectively |
(494 |
) |
|
(94 |
) |
|
(79 |
) |
|
703 |
|
Comprehensive loss |
$ |
(24,261 |
) |
|
$ |
(31,127 |
) |
|
$ |
(53,656 |
) |
|
$ |
(76,370 |
) |
Net loss per common share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.87 |
) |
|
$ |
(1.15 |
) |
|
$ |
(1.96 |
) |
|
$ |
(2.85 |
) |
Weighted-average number of shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
27,316 |
|
|
27,058 |
|
|
27,286 |
|
|
27,022 |
|
AnaptysBio (NASDAQ:ANAB)
Historical Stock Chart
From Jun 2024 to Jul 2024
AnaptysBio (NASDAQ:ANAB)
Historical Stock Chart
From Jul 2023 to Jul 2024