On February 25, 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 fourth quarter and year ended December 31, 2020 and provided pipeline updates (Press release, AnaptysBio, FEB 25, 2021, View Source [SID1234575663]).
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"We made progress in advancing AnaptysBio’s pipeline during 2020 and look forward to multiple clinical readouts from our wholly-owned programs in 2021. Imsidolimab will continue to be our key focus going forward as we anticipate GPP Phase 3 initiation and Phase 2 topline readouts from five other immune-dermatology indications through 2021 and 2022. We also anticipate commercial launch of dostarlimab this year and meaningful milestone and royalty revenue to AnaptysBio under our GSK partnership," said Hamza Suria, president and chief executive officer of AnaptysBio. "Our strategy is to continue advancing first-in-class immunology-focused therapeutic antibodies through key clinical data catalysts using a capital-efficient business model."
Imsidolimab (Anti-IL-36 Receptor) Program
In July, we announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, our proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with GPP.
In October, we announced positive topline data from an interim analysis of our imsidolimab GALLOP Phase 2 trial in GPP. Six of 8 patients achieved the primary endpoint of disease improvement upon Day 29, while erythema with skin pustules, which clinically defines GPP, decreased by 94% on Day 29 relative to baseline. We plan to report 16-week data from the GALLOP trial at a medical conference in 2021.
We anticipate initiation of a Phase 3 trial for imsidolimab in GPP during mid-2021 following completion of protocol alignment, and review of 16-week data from the Phase 2 GALLOP trial, with the FDA.
We are also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 59 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in Q1 2021.
We have expanded our imsidolimab program into third and fourth new clinical indications, EGFRi-mediated skin toxicities and ichthyosis, with interim top-line data from Phase 2 trials anticipated at the end of 2021 and in 2022, respectively, and we are also expanding the imsidolimab program into fifth and sixth new clinical indications, hidradenitis suppurativa and acne, with initiation of Phase 2 trials in these indications anticipated in Q2 2021.
We initiated a worldwide registry of GPP and PPP patients, named RADIANCE, in Q1 2021, to improve understanding of the patient journey and support enrollment of future trials.
ANB030 (Anti-PD-1 Agonist) Program
We anticipate topline data 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 in mid-2021.
Preclinical translational data using ANB030 was presented in March 2020 at the Festival of Biologics Meeting.
We anticipate initiating Phase 2 trials of ANB030 in alopecia areata and vitiligo in Q4 2021.
ANB032 (Anti-BTLA Modulator) Program
We filed a Clinical Trial Notification ("CTN") in Australia for ANB032, our wholly-owned BTLA modulator antibody, during the first quarter of 2021 and anticipate initiating a healthy volunteer Phase 1 trial in the first half of 2021 upon clearance of the CTN.
We presented preclinical data regarding ANB032 at the 2020 Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting in October 2020.
Etokimab (ANB020 Anti-IL-33) Program
We discontinued further development of etokimab, our anti-IL-33 antibody previously referred to as ANB020, following review of topline week 16 data from the approximately 100-patient ECLIPSE trial in chronic rhinosinusitis with nasal polyps (CRSwNP), where patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant over placebo on either co-primary endpoint.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK
In October 2020, we amended our immuno-oncology collaboration with GSK resulting in increased financial consideration to AnaptysBio. Royalties due to AnaptysBio for dostarlimab were increased to 8-25% of global net sales, where AnaptysBio will receive 8% of annual global net sales below $1 billion, and 12-25% of net sales above $1 billion. The $1.1 billion in cash milestone payments due under the collaboration agreement remain unchanged, and AnaptysBio anticipates receiving $75 million in such cash milestones over the next 18 months as dostarlimab obtains FDA and EMA regulatory approval for the first two indications. An additional $165 million in sales milestones is anticipated by AnaptysBio upon achievement of certain dostarlimab annual sales revenues. GSK also agreed, starting January 1, 2021, to pay AnaptysBio a 1% royalty on all of GSK’s global net sales of Zejula. In addition, GSK paid AnaptysBio a one-time cash payment of $60 million in Q4 2020. In exchange, AnaptysBio provided GSK with freedom to conduct development and commercialization of Zejula in combination with third-party molecules and settled the dispute between AnaptysBio and GSK.
US BLA and European Union EMA approvals for dostarlimab are anticipated for endometrial cancer in H1 2021, which will result in $20 million and $10 million milestone payments, respectively. The FDA recently accepted a subsequent US BLA for dostarlimab in pan-deficient mismatch repair tumors and we anticipate receiving a $10 million payment from GSK in Q1 2021 as a result of this milestone.
Board of Directors
In January 2021, the Company appointed Dr. Magda Marquet to its board of directors. She is the co-founder of AltheaDx, a commercial stage, precision medicine company, and co-founded Althea Technologies and as its co-CEO led the company to become a highly profitable, commercial company. Prior to starting Althea Technologies, Dr. Marquet held several positions in pharmaceutical development in companies such as Vical and Amylin Pharmaceuticals. She currently serves on the Board of Directors of Arcturus Therapeutics, Micronoma, Matrisys Biosciences and ProciseDx.
Fourth Quarter Financial Results
Cash, cash equivalents and investments totaled $411.2 million as of December 31, 2020 compared to $428.5 million as of December 31, 2019, for a net decrease of $17.3 million. The decrease relates primarily to cash used for operating activities partially offset by an increase in collaboration revenue of $67.0 million.
Collaboration revenue was $60.0 million and $75.0 million for the three and twelve months ended December 31, 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab and the $60.0 million amendment related payment from GSK, compared to $3.0 million and $8.0 million for the three and twelve months ended December 31, 2019.
Research and development expenses were $21.6 million and $80.0 million for the three and twelve months ended December 31, 2020, compared to $21.4 million and $99.3 million for the three and twelve months ended December 31, 2019. The annual decrease was due primarily to reduced outside services for manufacturing and clinical activities based on the timing of projects.
General and administrative expenses were $5.1 million and $18.9 million for the three and twelve months ended December 31, 2020, compared to $3.8 million and $16.1 million for the three and twelve months ended December 31, 2019. The increase was due primarily to increased legal and insurance expenses.
Net income was $33.6 million for the three months ended December 31, 2020, or a net income per share of $1.23 and a net loss of $19.9 million for the twelve months ended December 31, 2020, or a net loss per share of $0.73, compared to a net loss of $20.3 million and $97.3 million for the three and twelve months ended December 31, 2019, or a net loss per share of $0.75 and $3.60.
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.