AnaptysBio Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Pipeline Update
- Imsidolimab GPP GALLOP Phase 2 16-week data presented at 2021
EADV Congress and Phase3 GPP GEMINI-1 trial initiated
- Top-line data anticipated from ongoing imsidolimab ACORN Phase 2 trial in moderate-to-severe acne in H1 2022 and HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa in H2 2022
- Rosnilimab AZURE Phase 2 trial initiated in alopecia areata following positive Phase 1 top-line data in single and multiple ascending dose healthy volunteer cohorts
- Top-line data from ongoing ANB032 healthy volunteer Phase 1 clinical trial anticipated in H1 2022
- JEMPERLI royalty monetization transaction completed with
Sagard Healthcare Royalty Partnersfor $250 millionupfront payment in exchange for capped return on royalties and certain milestones below $1 billionin annual sales
- Ended 2021 with approximately $615 million in cash and will continue to operate in a capital-efficient manner
“We advanced our wholly-owned antibody product pipeline and completed a
Imsidolimab (Anti-IL-36 Receptor) Program
- Following an end-of-Phase 2 meeting with the FDA, we initiated our GEMINI-1 Phase 3 trial of imsidolimab in generalized pustular psoriasis (GPP) where the primary endpoint 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. These same patients will subsequently be enrolled into GEMINI-2, which will assess 6 months of monthly subcutaneous dosing and safety follow-up.
- 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 announced positive top-line data from a randomized placebo-controlled healthy volunteer single and multiple ascending dose Phase 1 trial of rosnilimab, our investigational wholly-owned anti-PD-1 agonist therapeutic antibody, previously known as ANB030. Top-line data demonstrated favorable safety, pharmacokinetics and pharmacodynamic results, which supported initiation of our Phase 2 AZURE clinical trial of rosnilimab in alopecia areata.
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
- We completed a royalty monetization agreement with
Sagard Healthcare Royalty Partnerswhere AnaptysBioreceived a $250 millionpayment in exchange for JEMPERLI royalties due to AnaptysBioon annual commercial sales below $1 billionand 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.
Fourth Quarter Financial Results
- Cash, cash equivalents and investments totaled
$615.2 millionas of December 31, 2021, compared to $411.2 millionas of December 31, 2020, for an increase of $204.0 million. The increase relates primarily to cash received from the royalty monetization transaction with Sagard Healthcare Partnersoffset by cash used for operating activities.
- Collaboration revenue was
$1.0 millionand $63.2 millionfor the three and twelve months ended December 31, 2021. The $1.0 millionearned during the fourth quarter primarily relates to royalty revenue earned for sales of JEMPERLI (dostarlimab) and Zejula by GSK, compared to $60.0 millionand $75 millionof milestone revenue for the three and twelve months ended December 31, 2020.
- Research and development expenses were
$26.8 millionand $98.5 millionfor the three and twelve months ended December 31, 2021, compared to $21.6 millionand $80.0 millionfor the three and twelve months ended December 31, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
- General and administrative expenses were
$5.4 millionand $21.5 millionfor the three and twelve months ended December 31, 2021, compared to $5.1 millionand $18.9 millionfor the three and twelve months ended December 31, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
- Net loss was
$32.5 millionand $57.8 millionfor the three and twelve months ended December 31, 2021, or a net loss per share of $1.18, and $2.11, compared to net income of $33.6 millionfor the three months ended December 31, 2020or net income per share of $1.23and a net loss of $19.9 millionfor the twelve months ended December 31, 2020, or net loss per share of $0.73.
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, moderate-to-severe acne, and moderate-to-severe hidradenitis suppurativa; rosnilimab, its anti-PD-1 agonist program, previously referred to as ANB030, for the treatment of moderate-to-severe alopecia areata; 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.
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 2 clinical trial in alopecia areata, and ANB032’s healthy volunteer Phase 1 trial; the risk that commercial sales of JEMPERLI may not reach expected levels under the GSK collaboration; and our projected use of our cash resources. 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
Consolidated Balance Sheets
(in thousands, except par value data)
|Cash and cash equivalents||$||495,729||$||250,456|
|Receivables from collaborative partners||876||—|
|Prepaid expenses and other current assets||4,903||2,908|
|Total current assets||553,876||396,561|
|Property and equipment, net||2,283||1,783|
|Operating lease right-of-use assets||19,558||344|
|Other long-term assets||256||258|
|Long-term restricted cash||—||60|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current portion of operating lease liability||1,505||342|
|Total current liabilities||16,099||19,821|
|Liability related to sale of future royalties||251,093||—|
|Operating lease liability, net of current portion||19,450||—|
|Additional paid in capital||678,575||660,665|
|Accumulated other comprehensive loss||(422||)||(4||)|
|Total stockholders’ equity||356,428||396,731|
|Total liabilities and stockholders’ equity||$||643,070||$||416,552|
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
|Three Months Ended
|Research and development||26,776||21,567||98,496||80,025|
|General and administrative||5,392||5,088||21,493||18,854|
|Total operating expenses||32,168||26,655||119,989||98,879|
|Income (loss) from operations||(31,157||)||33,345||(56,814||)||(23,879||)|
|Other income (expense), net:|
|Non-cash interest expense for the sale of future royalties||(1,450||)||—||(1,450||)||—|
|Other (expense) income, net||1||(75||)||37||(11||)|
|Total other income (expense), net||(1,381||)||301||(982||)||3,948|
|Net income (loss)||(32,538||)||33,646||(57,796||)||(19,931||)|
|Other comprehensive (loss) income:|
|Unrealized (loss) income on available for sale securities, net of tax of
|Comprehensive income (loss)||$||(32,760||)||$||33,383||$||(58,214||)||$||(20,273||)|
|Net income (loss) per common share:|
|Weighted-average number of shares outstanding:|
Source: AnaptysBio, Inc.