On August 7, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the second quarter ended June 30, 2023 and provided a business update (Press release, AnaptysBio, AUG 7, 2023, View Source [SID1234633860]).

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"We have made substantial operating progress including initiating a Phase 2b trial in atopic dermatitis (AD) for ANB032, our BTLA agonist, and approaching initiation of a Phase 2b trial in RA for rosnilimab, our PD-1 agonist," said Daniel Faga, president and chief executive officer of AnaptysBio. "Additionally, we are excited to share that we recently completed enrollment of the GEMINI-1 Phase 3 clinical trial for imsidolimab in GPP and expect to share top-line data in Q4 2023."

"We are excited to appoint Dan Faga to the permanent position of president and CEO," said Jamie Topper, M.D., Ph. D., chairman of the Board of Directors. "Over the last year, Anaptys has completed its strategic portfolio review and Dan led the transition refocusing on the broad development of our differentiated immune cell modulators, including our checkpoint agonist pipeline, in autoimmune and inflammatory diseases. With Dan and his talented team in place, and our strong capital position, the company is well positioned as it enters its next phase of development and growth."

Updates on Wholly Owned Immune Cell Modulator Pipeline

ANB032 (BTLA agonist antibody)

Initiated a global Phase 2b trial in moderate-to-severe AD
160-patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and six-month follow-up period on well established endpoints, including EASI75 and IGA 0/1
Top-line week 14 data anticipated by year-end 2024
Hosted a virtual BTLA Agonist (ANB032) R&D Event in May 2023
Replay of the audio webcast is available here
Rosnilimab (PD-1 agonist antibody)

Anticipate initiation later in Q3 2023 of a global Phase 2b trial in moderate-to-severe RA
Multi-hundred patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab for up to six months on well-established endpoints including ACR20/50/70 and DAS28
Top-line week 12 data anticipated by mid-year 2025
Plan to initiate a second global Phase 2 trial, in a yet to-be-announced indication, by year-end 2023
Plan to host a virtual PD-1 Agonist (rosnilimab) R&D Event in Q4 2023
ANB033 (anti-CD122 antagonist antibody)

Presented poster on preclinical data for ANB033, an anti-CD122 antagonist for the treatment of inflammatory diseases, at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting, in June 2023
Poster presentation is available here
Plan to submit an Investigational New Drug (IND) application in H1 2024
Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing

Completed enrollment of the GEMINI-1 Phase 3 trial for imsidolimab (IL-36R) in GPP per the initial target enrollment (n=45)
Top-line data anticipated in Q4 2023
Plan to out-license imsidolimab prior to potential FDA approval
Updates on GSK Immuno-Oncology Financial Collaboration

GSK received U.S FDA approval for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer on July 31, 2023
Jemperli is the first immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
GSK anticipates top-line data in H1 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer
GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
Organizational Updates

Announced appointment of Daniel Faga to the permanent position of president and chief executive officer of the Company
Mr. Faga will retain his position on the Company’s Board of Directors
Announced appointments of Luisa Salter-Cid, Ph.D., and Dolca Thomas, M.D., to the Company’s Scientific Advisory Board (SAB)
Dr. Salter-Cid is the current chief scientific officer at Pioneering Medicines, a strategic initiative within Flagship Pioneering. She had extensive experience at Bristol-Meyers Squibb where she led teams that advanced more than 20 compounds into clinical development.
Dr. Thomas is currently a venture partner at Samsara BioCapital and serves on the Board of Directors of Allakos Therapeutics, Chinook Therapeutics and Ventus Therapeutics. Dr. Thomas has extensive experience in both large pharma and biotech. Among her prior roles includes serving as Principia’s chief medical officer from 2018 until the Sanofi acquisition in September 2020. Dr. Thomas was also vice president and global head of Translational Medicine for Immunology, Inflammation, and Infectious Disease at Roche, where she was responsible for advancing multiple product candidates through clinical development.
Read their full bios here
Year-End Cash Guidance

Reiterating cash runway through year-end 2026 with updated expected year-end 2023 cash and investments of $380 – $395 million
Second Quarter Financial Results

Cash, cash equivalents and investments totaled $488.7 million as of June 30, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $95.5 million. The decrease relates primarily to cash used for the $50 million stock repurchase program and operating activities.
Collaboration revenue was $3.5 million and $4.8 million for the three and six months ended June 30, 2023, compared to $1.2 million and $2.2 million for the three and six months ended June 30, 2022. The change is due primarily to increased royalties recognized for sales of Jemperli.
Research and development expenses were $32.9 million and $67.9 million for the three and six months ended June 30, 2023, compared to $20.8 million and $43.4 million for the three and six months ended June 30, 2022. The increase was due primarily to manufacturing and development costs for imsidolimab, rosnilimab, ANB032 and ANB033. The R&D non-cash, stock-based compensation expense was $2.7 million and $5.5 million for the three and six months ended June 30, 2023 as compared to $1.8 million and $3.4 million in the same period in 2022.
General and administrative expenses were $10.7 million and $21.5 million for the three and six months ended June 30, 2023, compared to $8.2 million and $18.4 million for the three and six months ended June 30, 2022. The G&A non-cash, stock-based compensation expense was $5.7 million and $11.8 million for the three and six months ended June 30, 2023 as compared to $4.9 million and $11.0 million in the same period in 2022.
Net loss was $39.8 million and $84.1 million for the three and six months ended June 30, 2023, or a net loss per share of $1.50 and $3.08, compared to a net loss of $32.6 million and $68.8 million for the three and six months ended June 30, 2022, or a net loss per share of $1.15 and $2.46.