AnaptysBio Announces First Quarter 2023 Financial Results and Provides Pipeline Update
- Initiated a global Phase 2b trial to treat atopic dermatitis with ANB032, a BTLA agonist
- Hosting a virtual BTLA Agonist (ANB032) R&D Event on
May 25, 2023 - Announced International Societies for Investigative Dermatology (ISID) Annual Meeting poster presentation for ANB032, a BTLA agonist, Phase 1 data
- Initiating a global Phase 2b trial to treat rheumatoid arthritis in Q3 2023 and a second Phase 2 trial, in an indication to be announced, by year-end 2023 with rosnilimab, a PD-1 agonist
- Reiterating cash runway through year-end 2026 with expected year-end 2023 cash and investments of
$370 –$385 million
“We’re excited about our progress as we continue to develop best-in-class antibodies across a number of high-value immune cell modulatory targets. We have initiated our global Phase 2b trial in moderate-to-severe atopic dermatitis (AD) for ANB032, our BTLA agonist, and will host a virtual R&D event on
Updates on Wholly Owned Immune Cell Modulator Pipeline
Rosnilimab (PD-1 agonist antibody)
- Anticipate initiation in Q3 2023 of a global Phase 2b trial in moderate-to-severe rheumatoid arthritis (RA)
- Multi-hundred patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab for up to 6 months on well-established endpoints including ACR20/50/70 and DAS28
- Top-line interim data anticipated by mid-year 2025
- Plan to initiate second global Phase 2 trial, in an indication to be announced, by year-end 2023
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 on well-established endpoints, including EASI75 and IGA 0/1
- Top-line interim data anticipated by year-end 2024
- Presented poster on Phase 1 data for ANB032, a BTLA agonist for the treatment of moderate-to-severe AD, at International Societies for Investigative Dermatology (ISID) Annual Meeting,
May 11, 2023 , inJapan - Planning to host a virtual BTLA Agonist (ANB032) R&D Event on
Thursday, May 25, 2023 at1:15pm PT /4:15pm ET - Management will host the event via conference call and webcast, with an accompanying slide presentation
- The live audio webcast, as well as a replay of the presentation, will be available on the investor section of the
AnaptysBio website at https://ir.anaptysbio.com/events
ANB033 (anti-CD122 antagonist antibody)
- Plan to submit an Investigational New Drug (IND) application in H1 2024
Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing
- Announced publication of Phase 2 GALLOP data for imsidolimab, an investigational, wholly owned, anti-IL-36R antagonist IgG4 antibody in generalized pustular psoriasis (GPP) in
The British Journal of Dermatology onApril 30, 2023 - Anticipate top-line data from the ongoing GEMINI-1 Phase 3 trial in Q4 2023
- Plan to out-license imsidolimab prior to potential FDA approval
- Plan to out-license imsidolimab prior to potential FDA approval
GSK Immuno-Oncology Financial Collaboration
- GSK announced publication of RUBY Phase 3 clinical data for JEMPERLI (dostarlimab-gxly), an anti-PD-1 antagonist antibody discovered at AnaptysBio and licensed to GSK, in
The New England Journal of Medicine and presented simultaneously at ESMO Virtual Plenary and SGO Annual Meeting inMarch 2023 - JEMPERLI has the potential for a first-in-class approval in primary advanced or recurrent endometrial cancer after meeting the primary endpoint in the pivotal RUBY Phase 3 trial demonstrating JEMPERLI plus chemotherapy significantly improved PFS versus chemotherapy plus placebo
- GSK plans regulatory submissions in H1 2023
- GSK anticipates top-line data from the ongoing FIRST Phase 3 trial, a randomized, double-blind, comparison of platinum-based therapy with dostarlimab and niraparib versus standard of care platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer, in H2 2023
- GSK anticipates top-line data from the ongoing COSTAR Lung Phase 3 trial, a randomized, open label 3-arm 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, in 2024
Stock Repurchase Program and Year-End Cash Guidance
- Completed Stock Repurchase Program, authorized in
January 2023 , of$50 .0 million of the Company’s outstanding common stock - Reiterating cash runway through year-end 2026 with expected year-end 2023 cash and investments of
$370 –$385 million
First Quarter Financial Results
- Cash, cash equivalents and investments totaled
$526.1 million as ofMarch 31, 2023 , compared to$584.2 million as ofDecember 31, 2022 , for a decrease of$58.1 million . The decrease relates primarily to cash used for the stock repurchase program and operating activities. - Collaboration revenue was
$1.4 million for the three months endedMarch 31, 2023 , compared to$1.0 million for the three months endedMarch 31, 2022 . The change is due to increased royalties recognized for sales of JEMPERLI and Zejula in the first quarter of 2023. - Research and development expenses were
$35.0 million for the three months endedMarch 31, 2023 , compared to$22.5 million for the three months endedMarch 31, 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$2.8 million for the three months endedMarch 31, 2023 as compared to$1.7 million in the same period in 2022. - General and administrative expenses were
$10.8 million for the three months endedMarch 31, 2023 , compared to$10.2 million for the three months endedMarch 31, 2022 . The G&A non-cash, stock-based compensation expense was$6.1 million for the three months endedMarch 31, 2023 and 2022. - Net loss was
$44.3 million for the three months endedMarch 31, 2023 , or a net loss per share of$1.58 , compared to a net loss of$36.3 million for the three months endedMarch 31, 2022 , or a net loss per share of$1.31 .
About
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 trials 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; 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
Contact:
Senior Director, Investor Relations and
858.732.0178
investors@anaptysbio.com
Consolidated Balance Sheets | |||||||
(in thousands, except par value data) | |||||||
(unaudited) | |||||||
2023 |
2022 |
||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 94,562 | $ | 71,308 | |||
Receivables from collaborative partners | 1,523 | 1,419 | |||||
Short-term investments | 336,589 | 369,933 | |||||
Prepaid expenses and other current assets | 4,480 | 4,545 | |||||
Total current assets | 437,154 | 447,205 | |||||
Property and equipment, net | 1,982 | 2,089 | |||||
Operating lease right-of-use assets | 17,471 | 17,898 | |||||
Long-term investments | 94,929 | 142,935 | |||||
Other long-term assets | 256 | 256 | |||||
Total assets | $ | 551,792 | $ | 610,383 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,168 | $ | 2,784 | |||
Accrued expenses | 30,956 | 21,633 | |||||
Current portion of operating lease liability | 1,671 | 1,637 | |||||
Total current liabilities | 35,795 | 26,054 | |||||
Liability related to sale of future royalties | 307,516 | 304,413 | |||||
Operating lease liability, net of current portion | 17,388 | 17,813 | |||||
Stockholders’ equity: | |||||||
Preferred stock, |
— | — | |||||
Common stock, |
27 | 29 | |||||
Additional paid in capital | 689,065 | 717,797 | |||||
Accumulated other comprehensive loss | (3,267 | ) | (5,246 | ) | |||
Accumulated deficit | (494,732 | ) | (450,477 | ) | |||
Total stockholders’ equity | 191,093 | 262,103 | |||||
Total liabilities and stockholders’ equity | $ | 551,792 | $ | 610,383 |
Consolidated Statements of Operations and Comprehensive Loss | ||||||||
(in thousands, except per share data) | ||||||||
(unaudited) | ||||||||
Three Months Ended |
||||||||
2023 | 2022 | |||||||
Collaboration revenue | $ | 1,374 | $ | 970 | ||||
Operating expenses: | ||||||||
Research and development | 34,957 | 22,516 | ||||||
General and administrative | 10,818 | 10,203 | ||||||
Total operating expenses | 45,775 | 32,719 | ||||||
Loss from operations | (44,401 | ) | (31,749 | ) | ||||
Other income (expense), net: | ||||||||
Interest income | 4,486 | 342 | ||||||
Non-cash interest expense for the sale of future royalties | (4,336 | ) | (4,854 | ) | ||||
Other (expense) income, net | (4 | ) | 6 | |||||
Total other income (expense), net | 146 | (4,506 | ) | |||||
Net loss | (44,255 | ) | (36,255 | ) | ||||
Unrealized gain (loss) on available for sale securities | 1,979 | (2,012 | ) | |||||
Comprehensive loss | $ | (42,276 | ) | $ | (38,267 | ) | ||
Net loss per common share: | ||||||||
Basic and diluted | $ | (1.58 | ) | $ | (1.31 | ) | ||
Weighted-average number of shares outstanding: | ||||||||
Basic and diluted | 27,953 | 27,713 |
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Source: AnaptysBio, Inc.