On November 4, 2020 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 third quarter ended September 30, 2020 and provided pipeline updates (Press release, AnaptysBio, NOV 4, 2020, View Source [SID1234569972]).

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"We are excited with the recent interim results from our GALLOP trial and look forward to engaging with regulatory authorities to progress imsidolimab into registration trials for the treatment of GPP," said Hamza Suria, president and chief executive officer of AnaptysBio. "Under our amended immuno-oncology collaboration with GSK, we look forward to the anticipated first FDA approval of dostarlimab and its advancement for patients suffering with various oncological disorders."

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. Treatment of GPP by imsidolimab is being evaluated in the GALLOP Phase 2 trial.

Patients demonstrated rapid onset, overall safety and promising efficacy upon imsidolimab monotherapy in a Day 29 interim analysis of our GALLOP Phase 2 GPP trial. 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.
An end-of-Phase 2 meeting, based upon data available from the 8 patients enrolled in the GALLOP trial, is anticipated in Q4 2020.

We are also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in approximately 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, which is now fully enrolled with topline data anticipated in Q1 2021.

We anticipate expanding the imsidolimab program in two new indications, EGFR-mediated skin toxicities and ichthyosis, based upon human translational data that suggests each of these conditions are mediated by dysregulated signaling through the IL-36 pathway. Initiation of Phase 2 trials for each of these indications is anticipated in Q4 2020.

Worldwide registry of GPP and PPP patients, named RADIANCE, to be initiated 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.
ANB032 (Anti-BTLA Modulator) Program

We anticipate filing an investigational new drug application (IND) for ANB032, our wholly-owned BTLA modulator antibody, in Q4 2020. 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

In an interim analysis at week 8 of the ongoing ECLIPSE Phase 2 trial of etokimab in chronic rhinosinusitis with nasal polyps, patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant improvement in their bilateral nasal polyps score (NPS), an endoscopic measure of nasal occlusion, and their sino-nasal outcome test (SNOT-22), a patient reported quality-of-life assessment, versus placebo at the week 8 timepoint. Both endpoints demonstrated statistically significant improvement over baseline levels of NPS and SNOT-22. Blood eosinophil levels, which are a biomarker of etokimab’s mechanism, demonstrated statistically significant reduction relative to baseline in both etokimab treatment arms. We intend to decide on a path forward for the etokimab program after reviewing week 16 primary endpoint data by year-end 2020.
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 has 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 has agreed to pay AnaptysBio a one-time cash payment of $60 million within 30 days. In exchange, AnaptysBio has provided GSK with freedom to conduct development and commercialization of Zejula in combination with third-party molecules and settled the ongoing legal dispute between AnaptysBio and GSK.
Third Quarter Financial Results

Cash, cash equivalents and investments totaled $374.5 million as of September 30, 2020 compared to $428.5 million as of December 31, 2019, for a decrease of $54.0 million. The decrease relates primarily to cash used for operating activities.

Collaboration revenue was zero and $15.0 million for the three and nine months ended September,30 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab by GSK, compared to zero and $5 million for the three and nine months ended September 30, 2019.

Research and development expenses were $19.5 million and $58.5 million for the three and nine months ended September 30, 2020, compared to $29.9 million and $77.9 million for the three and nine months ended September 30, 2019. The decrease was due primarily to reduced outside services for manufacturing and clinical expenses based on the timing of projects.

General and administrative expenses were $4.8 million and $13.8 million for the three and nine months ended September 30, 2020, compared to $3.8 million and $12.3 million for the three and nine months ended September 30, 2019. The increase was due primarily to increased legal and insurance expenses.

Net loss was $23.8 million and $53.6 million for the three and nine months ended September 30, 2020, or a net loss per share of $0.87 and $1.96, compared to a net loss of $31.0 million and $77.1 million for the three and nine months ended September 30, 2019, or a net loss per share of $1.15 and $2.85.

Financial Guidance
AnaptysBio expects its net cash burn in 2020 will be close to breakeven assuming the $20 million milestone payment upon first FDA approval of dostarlimab is received by year-end. We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2023.