AnaptysBio Announces First Quarter 2021 Financial Results and Provides Pipeline Updates
- Imsidolimab Phase 3 GPP trial anticipated to commence in mid-2021 following FDA end-of-Phase 2 meeting held during Q2 2021
- JEMPERLI (dostarlimab), our PD-1 antagonist antibody partnered with GlaxoSmithKline (GSK), was approved for endometrial cancer in the US and EU during Q2 2021, earning
$30 millionin cash milestones and 8-25% royalties, plus Zejula (niraparib) 1% royalty revenue earned starting January 2021
- Expanded imsidolimab clinical development program with initiation of Phase 2 trials in acne and hidradenitis suppurativa, with top-line data readouts anticipated in H1 2022 and H2 2022, respectively
- Top-line data from POPLAR phase 2 clinical trial of imsidolimab monotherapy in palmoplantar pustulosis (PPP), disclosed in Q1 2021, failed to meet primary endpoint
- Ongoing healthy volunteer Phase 1 trial with ANB030, with top-line data anticipated in H2 2021 and initiation of Phase 2 clinical trials in alopecia areata and vitiligo in Q4 2021
- Achievement of first-in-human dosing of ANB032 with healthy volunteer Phase 1 top-line data anticipated in H1 2022
“We look forward to advancing imsidolimab into a Phase 3 trial for GPP following our recent end-of-Phase 2 meeting with the FDA,” said
Imsidolimab (Anti-IL-36 Receptor) Program
- We held an end-of-Phase 2 meeting with the FDA during Q2 2021 to review an orphan disease Phase 3 development plan for imsidolimab for the treatment of GPP and anticipate announcing key aspects of our Phase 3 trial design upon its initiation in mid-2021. Our worldwide registry of GPP patients, named RADIANCE, is ongoing, and we expect that this study will improve our understanding of the patient journey and support enrollment of our Phase 3 clinical trial. While initial GPP epidemiology studies suggested at least 3,000 GPP patients in
the United States, medical claims analyses 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, by a physician between 2017 and 2019 using the International Classification of Diseases 10th Revision (ICD-10) billing code pertaining to GPP (L40.1).
- We initiated a Phase 2 clinical trial of imsidolimab in hidradenitis suppurativa, named HARP, where 120-patients are randomized equally between two dose levels of imsidolimab and placebo, and top-line data is anticipated in H2 2022. We also commenced an imsidolimab Phase 2 trial in moderate-to-severe acne, named ACORN, where 120-patients are randomized equally between two dose levels of imsidolimab and placebo, and top-line data is anticipated in H1 2022. We continue to anticipate top-line data at the end of 2021 from our EMERGE Phase 2 trial of imsidolimab in EGFR/MEK-mediated skin toxicities and top-line data from our Phase 2 INSPIRE trial in ichthyosis during 2022.
- We announced in Q1 2021 top-line data from our POPLAR phase 2 clinical trial of imsidolimab monotherapy in PPP, which failed to meet the trial’s primary endpoint. While we continue to review secondary endpoints to further understand the activity of imsidolimab in various PPP patient subsets, we do not currently plan to pursue further clinical development of imsidolimab in PPP.
ANB030 (Anti-PD-1 Agonist) Program
- We anticipate top-line data in H2 2021 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.
- We plan to initiate Phase 2 clinical trials of ANB030 in alopecia areata and vitiligo in Q4 2021.
- Preclinical translational data using ANB030 was presented in
March 2020at the Festival of Biologics Meeting.
ANB032 (Anti-BTLA Modulator) Program
- We achieved first-in-human dosing of ANB032, our wholly-owned BTLA modulator antibody, upon initiation of a healthy volunteer Phase 1 trial in the first quarter of 2021, under an Australian Clinical Trial Notification (CTN), and anticipate top-line data from this trial during the first half of 2022.
- We presented preclinical data regarding ANB032 at the 2020
Federation of Clinical Immunology Societies (FOCIS) VirtualAnnual Meeting in October 2020.
GSK Partnered Programs
- A BLA for our most advanced partnered program, which is an anti-PD-1 antagonist antibody called JEMPERLI (dostarlimab), was approved by the FDA in
April 2021for the treatment of advanced or recurrent deficient mismatch repair endometrial cancer (dMMREC). This is the first AnaptysBio-generated antibody, of eight currently under clinical development, to obtain FDA approval. We earned a $20.0 millionmilestone payment as a result of this FDA approval.
April 2021the European Medicines Agency(EMA) granted conditional marketing authorization in the European Union for JEMPERLIfor use in women with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen, which approval makes JEMPERLI the first anti-PD-1 therapy available for endometrial cancer in Europe. We earned a $10.0 millionmilestone payment as a result of this approval.
- A second BLA submitted by GSK was accepted by the FDA during the first quarter of 2021 for JEMPERLI in pan-deficient mismatch repair tumors (PdMMRT). We received a
$10.0 millioncash milestone payment upon the FDA acceptance of GSK’s second FDA BLA for JEMPERLI and anticipate an additional $20.0 millioncash milestone payment upon FDA approval of this second FDA BLA of JEMPERLI during the second half of 2021. We anticipate an additional $15.0 millionand $165.0 millionin milestone payments upon achievement of certain JEMPERLI regulatory and commercial milestones, respectively.
- During Q1 2021, we recognized
$1.2 millionin royalty revenue related to GSK’s Zejula product sales, which we estimated based on GSK’s historical sales. In October 2020, we amended our GSK collaboration which resulted in increased royalties on global net sales of JEMPERLI to 8-25%, a 1% royalty rate on GSK’s global net sales of Zejula and a one-time cash payment of $60.0 million.
First Quarter Financial Results
- Cash, cash equivalents and investments totaled
$387.4 millionas of March 31, 2021compared to $411.2 millionas of December 31, 2020, for a decrease of $23.8 million. The decrease relates primarily to cash used for operating activities.
- Collaboration revenue was
$11.2 millionfor the three months ended March 31, 2021, $10.0 millionrelated to milestone revenue for the FDA accepted BLA filing of the second dostarlimab indication and $1.2 millionrelated to royalties on GSK’s Zejula product sales, compared to $15.0 millionof milestone revenue for the three months ended March 31, 2020.
- Research and development expenses were
$24.2 millionfor the three months ended March 31, 2021, compared to $21.0 millionfor the three months ended March 31, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
- General and administrative expenses were
$5.4 millionfor the three months ended March 31, 2021, compared to $4.3 millionfor the three months ended March 31, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
- Net loss was
$18.2 millionfor the three months ended March 31, 2021, or a net loss per share of $0.66, compared to a net loss of $8.3 millionfor the three months ended March 31, 2020, or a net loss per share of $0.30.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including imsidolimab’s Phase 2 clinical trials in EGFRi, ichthyosis, hidradenitis suppurativa and acne, ANB030’s Phase 2 clinical trials in alopecia areata and vitiligo, and ANB032’s healthy volunteer Phase 1 trial; the timing of announcement of key aspects of imsidolimab’s GPP Phase 3 clinical trial design and initiation of the trial; the milestones and royalty payments to be received under the GSK collaboration; and our projected 2021 cash burn and cash runway. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the
Consolidated Balance Sheets
(in thousands, except par value data)
|Cash and cash equivalents||$||284,148||$||250,456|
|Receivable from collaborative partners||1,247||—|
|Prepaid expenses and other current assets||5,464||2,908|
|Total current assets||387,131||396,561|
|Property and equipment, net||1,754||1,783|
|Other long-term assets||477||602|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Other current liabilities||197||342|
|Total current liabilities||14,475||19,821|
|Additional paid in capital||664,147||660,665|
|Accumulated other comprehensive loss||(111||)||(4||)|
|Total stockholders’ equity||381,943||396,731|
|Total liabilities and stockholders’ equity||$||396,418||$||416,552|
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
|Three Months Ended
|Research and development||24,185||20,968|
|General and administrative||5,423||4,285|
|Total operating expenses||29,608||25,253|
|Loss from operations||(18,361||)||(10,253||)|
|Other income, net:|
|Other income, net||3||94|
|Total other income, net||198||1,991|
|Unrealized (loss) income on available for sale securities||(107||)||807|
|Net loss per common share:|
|Basic and diluted||$||(0.66||)||$||(0.30||)|
|Weighted-average number of shares outstanding:|
|Basic and diluted||27,361||27,264|
Source: AnaptysBio, Inc.