AnaptysBio Announces Third Quarter 2021 Financial Results and Provides Pipeline Updates
- Imsidolimab GPP GALLOP Phase 2 16-week data presented at 2021
EADV Congress and GEMINI-1 Phase3 trial initiated subsequent to FDA end-of-Phase 2 meeting
- Top-line data from ongoing imsidolimab ACORN Phase 2 trial in moderate-to-severe acne anticipated in H1 2022 and HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa in H2 2022
- Rosnilimab Phase 1 healthy volunteer top-line data and initiation of AZURE Phase 2 trial in alopecia areata anticipated in Q4 2021
- JEMPERLI (dostarlimab) was approved for mismatch repair deficient (dMMR) recurrent or advanced solid tumors in the US, earning
$20 millioncash milestone during Q3 2021
- JEMPERLI royalty monetization transaction signed with
Sagard Healthcare Royalty Partnersfor $250 millionupfront payment in exchange for capped return on royalties and certain milestones below $1 billionin annual sales
- Expect to end 2021 with approximately
$600 millionin cash and will continue to operate in a capital-efficient manner
“Our wholly-owned pipeline continues to make progress with the recent initiation of our imsidolimab GEMINI-1 Phase 3 trial in GPP and anticipated initiation of our rosnilimab AZURE alopecia areata Phase 2 trial during the remainder of 2021,” said
Imsidolimab (Anti-IL-36 Receptor) Program
- Following an end-of-Phase 2 meeting with the FDA in Q2 2021, we publicly disclosed Phase 3 trial designs for imsidolimab in generalized pustular psoriasis (GPP), GEMINI-1 and GEMINI-2. The primary endpoint of our GEMINI-1 Phase 3 trial 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. GEMINI-2 will assess 6 months of monthly subcutaneous dosing and safety follow-up of those same patients. GEMINI-1 was initiated in Q3 2021.
- Full data from the Phase 2 GALLOP trial in GPP, including efficacy and safety of imsidolimab treatment through week 16, was disclosed in an oral presentation by Dr.
Johann Gudjonsson, professor of Dermatology at the University of Michigan, at the European Academy of Dermatology and Venereology (EADV) Congresson October 2nd, 2021. Imsidolimab demonstrated rapid and sustained efficacy with 6 of 8 (75%) GPP patients achieving the primary endpoint at week 4 and 16. We also observed early reduction of erythema with pustules by 60% at week 1, 94% reduction at week 4, 98% reduction at week 16, each versus baseline.
- 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 anticipate top-line data in Q4 2021 from our ongoing Phase 1 healthy volunteer 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 randomized, 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 under an immune-oncology partnership with GSK, was approved in a second clinical indication by the FDA in
August 2021for the treatment of pan-deficient mismatch repair tumors. We received $20 millionfrom GSK upon this approval.
- We announced the signing of a royalty monetization agreement with
Sagard Healthcare Royalty Partnerswhere AnaptysBiowill receive a $250 millionpayment upon closing 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. The closing of the transaction is subject to the satisfaction of customary closing conditions and is anticipated by year-end 2021.
Third Quarter Financial Results
- Cash, cash equivalents and investments totaled
$389.3 millionas of September 30, 2021, compared to $411.2 millionas of December 31, 2020, for a decrease of $21.9 million. The decrease relates primarily to cash used for operating activities.
- Collaboration revenue was
$20.9 millionand $62.2 millionfor the three and nine months ended September 30, 2021. The $20.9 millionearned during the third quarter primarily relates to milestone and royalty revenue for the US approval of JEMPERLI (dostarlimab), compared to zero and $15.0 millionof milestone revenue for the three and nine months ended September 30, 2020.
- Research and development expenses were
$22.2 millionand $71.7 millionfor the three and nine months ended September 30, 2021, compared to $19.5 millionand $58.5 millionfor the three and nine months ended September 30, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
- General and administrative expenses were
$5.4 millionand $16.1 millionfor the three and nine months ended September 30, 2021, compared to $4.8 millionand $13.8 millionfor the three and nine months ended September 30, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
- Net loss was
$6.7 millionand $25.3 millionfor the three and nine months ended September 30, 2021, or a net loss per share of $0.24, and $0.92, compared to a net loss of $23.8 millionand $53.6 millionfor the three and nine months ended September 30, 2020, or a net loss per share of $0.87and $1.96.
Following the anticipated closing of the Sagard royalty monetization transaction by the end of 2021, we anticipate ending 2021 with approximately
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 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; including the risk that the transaction with Sagard may not close when expected, or at all, the risk that commercial sales of JEMPERLI may not reach expected levels, 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
Consolidated Balance Sheets
(in thousands, except par value data)
|Cash and cash equivalents||$||336,328||$||250,456|
|Receivables from collaborative partners||761||—|
|Prepaid expenses and other current assets||11,759||2,908|
|Short-term restricted cash||60||—|
|Total current assets||386,644||396,561|
|Property and equipment, net||2,413||1,783|
|Operating lease right-of-use assets||19,778||344|
|Other long-term assets||258||258|
|Long-term restricted cash||—||60|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current portion of operating lease liability||1,097||342|
|Total current liabilities||20,889||19,821|
|Operating lease liability, net of current portion||19,838||—|
|Additional paid in capital||672,996||660,665|
|Accumulated other comprehensive loss||(200||)||(4||)|
|Total stockholders’ equity||383,608||396,731|
|Total liabilities and stockholders’ equity||$||424,335||$||416,552|
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
|Three Months Ended
||Nine Months Ended
|Research and development||22,221||19,542||71,720||58,458|
|General and administrative||5,432||4,794||16,101||13,766|
|Total operating expenses||27,653||24,336||87,821||72,224|
|Loss from operations||(6,763||)||(24,336||)||(25,657||)||(57,224||)|
|Other income, net:|
|Other income (expense), net||33||(56||)||36||64|
|Total other income, net||97||569||399||3,647|
|Unrealized loss on available for sale securities||(24||)||(494||)||(196||)||(79||)|
|Net loss per common share:|
|Basic and diluted||$||(0.24||)||$||(0.87||)||$||(0.92||)||$||(1.96||)|
|Weighted-average number of shares outstanding:|
|Basic and diluted||27,436||27,316||27,397||27,286|
Source: AnaptysBio, Inc.