AnaptysBio Announces Second Quarter 2021 Financial Results and Provides Pipeline Updates
- Imsidolimab GPP GEMINI-1 Phase 3 trial anticipated to initiate in Q3 2021 following recent FDA end-of-Phase 2 Meeting
- Imsidolimab GALLOP GPP Phase 2 trial 16-week data to be orally presented at the
EADV Congresson October 2nd, 2021
- Imsidolimab Phase 2 trials ongoing in acne, hidradenitis suppurativa, EGFR-mediated skin toxicity and ichthyosis, with multiple top-line data readouts anticipated in 2022
- Rosnilimab, previously referred to as ANB030, Phase 1 healthy volunteer top-line data and initiation of a Phase 2 trial in alopecia areata anticipated in Q4 2021
- JEMPERLI (dostarlimab), our PD-1 antagonist antibody, which our partner GlaxoSmithKline (GSK) anticipates to reach peak annual sales of £1-£2 billion, was approved for endometrial cancer in the US and EU, earning
$30 millionin cash milestones in Q2 2021 and 8-25% royalties on global net sales of JEMPERLI going forward
“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
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 Statesby 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) Congresson 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 2021for 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 AnaptysBiowill earn 8-25% royalties on global net sales of JEMPERLI. We received $20 millionand $10 millionmilestone payments upon FDA and EMA approval of JEMPERLI, respectively. We anticipate earning an additional $20 millionmilestone payment upon a second FDA BLA approval for JEMPERLI in pan-deficient mismatch repair tumors during the second half of 2021. AnaptysBiois due an additional $15 millionand $165 millionupon certain JEMPERLI regulatory and commercial milestones, respectively.
Second Quarter Financial Results
- Cash, cash equivalents and investments totaled
$396.3 millionas of June 30, 2021, compared to $411.2 millionas 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 millionand $41.3 millionfor the three and six months ended June 30, 2021. The $30 millionearned during the second quarter relates to milestone revenue for the US and EU approval of JEMPERLI (dostarlimab), compared to zero and $15 millionof milestone revenue for the three and six months ended June 30, 2020.
- Research and development expenses were
$25.3 millionand $49.5 millionfor the three and six months ended June 30, 2021, compared to $17.9 millionand $38.9 millionfor 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 millionand $10.7 millionfor the three and six months ended June 30, 2021, compared to $4.7 millionand $9 millionfor 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 millionand $18.6 millionfor 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 millionand $29.8 millionfor the three and six months ended June 30, 2020, or a net loss per share of $0.79and $1.09.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including imsidolimab’s Phase 2 clinical trials in acne, hidradenitis suppurativa, EGFRi and ichthyosis, rosnilimab’s Phase 1 healthy volunteer clinical trial and Phase 2 clinical trial in alopecia areata, and ANB032’s healthy volunteer Phase 1 trial; the timing of the initiation of imsidolimab’s GPP Phase 3 clinical trials; the milestones and royalty payments to be received under the GSK collaboration; and our projected 2021 cash burn and cash runway. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the
Consolidated Balance Sheets
(in thousands, except par value data)
|Cash and cash equivalents||$||332,254||$||250,456|
|Receivable from collaborative partners||642||—|
|Prepaid expenses and other current assets||6,508||2,908|
|Total current assets||398,061||396,561|
|Property and equipment, net||2,488||1,783|
|Operating lease right-of-use assets||20,278||344|
|Other long-term assets||258||258|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current portion of operating lease liability||555||342|
|Total current liabilities||20,616||19,821|
|Operating lease liability, net of current portion||20,222||—|
|Additional paid in capital||668,429||660,665|
|Accumulated other comprehensive loss||(176||)||(4||)|
|Total stockholders’ equity||385,731||396,731|
|Total liabilities and stockholders’ equity||$||426,569||$||416,552|
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
|Three Months Ended
||Six Months Ended
|Research and development||25,314||17,948||49,499||38,916|
|General and administrative||5,246||4,687||10,669||8,972|
|Total operating expenses||30,560||22,635||60,168||47,888|
|Loss from operations||(533||)||(22,635||)||(18,894||)||(32,888||)|
|Other income, net:|
|Other income, net||—||26||3||120|
|Total other income, net||104||1,087||302||3,078|
|Unrealized (loss) income on available for sale securities||(65||)||(392||)||(172||)||415|
|Net loss per common share:|
|Basic and diluted||$||(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|
Source: AnaptysBio, Inc.