On May 4, 2021 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the first quarter ended March 31, 2021 and provided pipeline updates (Press release, AnaptysBio, MAY 4, 2021, View Source [SID1234579061]).
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"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 Hamza Suria, president and chief executive officer of AnaptysBio. "AnaptysBio continues to pursue a capital-efficient business model where partnership revenues continue to support advancement of our wholly-owned pipeline poised to generate multiple clinical data catalysts through 2021 and 2022."
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 2020 at 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) Virtual Annual 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 2021 for 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 million milestone payment as a result of this FDA approval.
In April 2021 the European Medicines Agency (EMA) granted conditional marketing authorization in the European Union for JEMPERLI for 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 million milestone 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 million cash milestone payment upon the FDA acceptance of GSK’s second FDA BLA for JEMPERLI and anticipate an additional $20.0 million cash milestone payment upon FDA approval of this second FDA BLA of JEMPERLI during the second half of 2021. We anticipate an additional $15.0 million and $165.0 million in milestone payments upon achievement of certain JEMPERLI regulatory and commercial milestones, respectively.
During Q1 2021, we recognized $1.2 million in 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 million as of March 31, 2021 compared to $411.2 million as 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 million for the three months ended March 31, 2021, $10.0 million related to milestone revenue for the FDA accepted BLA filing of the second dostarlimab indication and $1.2 million related to royalties on GSK’s Zejula product sales, compared to $15.0 million of milestone revenue for the three months ended March 31, 2020.
Research and development expenses were $24.2 million for the three months ended March 31, 2021, compared to $21.0 million for 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 million for the three months ended March 31, 2021, compared to $4.3 million for 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 million for the three months ended March 31, 2021, or a net loss per share of $0.66, compared to a net loss of $8.3 million for the three months ended March 31, 2020, or a net loss per share of $0.30.
Financial Guidance
AnaptysBio expects its net cash burn in 2021 will be close to $100 million. We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2024.