On March 11, 2024 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the fourth quarter and year ended December 31, 2023 and provided a business update.
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"2023 was a remarkable year for Anaptys as we implemented a multi-year development plan investing across our best-in-class immune cell modulators (ICMs) to bring transformational medicines to patients living with heterogeneous, systemic autoimmune and inflammatory diseases, with the goal of restoring immune balance," said Daniel Faga, president and chief executive officer of Anaptys. "Enrollment is ongoing in three global Phase 2 trials for ANB032, our BTLA agonist, in atopic dermatitis and rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ulcerative colitis. Additionally, we expanded our portfolio by acquiring the rights to ANB101, a BDCA2 modulator, which targets plasmacytoid dendritic cells, known to be key drivers of interferon secretion and antigen presentation."
"We will have a number of important events in 2024 including the top-line data readout of ANB032’s Phase 2b trial in atopic dermatitis by year end," adds Faga. "We also plan to move our third and fourth ICMs — ANB033, our anti-CD122 antagonist, and ANB101 — into the clinic this year, with IND filings planned for Q2 and H2, respectively."
Updates on Wholly Owned Immune Cell Modulator Pipeline
ANB032 (BTLA agonist antibody)
Enrollment ongoing for global Phase 2b trial in moderate-to-severe atopic dermatitis (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 then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI75 and IGA 0/1
Reiterating top-line Week 14 data anticipated by year-end 2024
Presented poster on ANB032 preclinical data supporting the modulation of dendritic cell (DC) maturation and function, representing one of the mechanisms to address atopic dermatitis pathophysiology, at the 2024 AAD Annual Meeting in March 2024
Poster presentation is available here
Rosnilimab (PD-1 agonist antibody)
Enrollment ongoing for global Phase 2b trial in moderate-to-severe RA
420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI<=10, are eligible to be dosed for an additional 16-week all-active treatment period and then followed for a three-month off-drug follow-up period
Reiterating top-line Week 12 data anticipated by mid 2025
Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC
130-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission
Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period
Reiterating top-line Week 12 data anticipated by H1 2026
Presented posters on previously reported rosnilimab Phase 1 data and membrane proximal binding epitope to optimize PD-1 agonist signaling at the American College of Rheumatology (ACR) Convergence 2023 in November 2023 and at the 19th Congress of the European Crohn’s and Colitis Organisation (ECCO) in February 2024
Poster presentations are available here
Hosted a virtual Rosnilimab (PD-1 Agonist) R&D Event in October 2023
Replay of the audio webcast is available here
ANB033 (anti-CD122 antagonist antibody)
Plan to submit an Investigational New Drug (IND) application in Q2 2024
ANB101 (BDCA2 modulator antibody)
Announced exclusive global license of ANB101 in November 2023
Anaptys also received the same rights to ANB102, an extended half-life BDCA2 modulator with the potential to enable quarterly or less frequent dosing
License from Centessa Pharmaceuticals in exchange for a one-time upfront cash payment of $7 million, inclusive of $3 million for manufactured and released GMP supply of ANB101
Plan to submit an IND application in H2 2024
Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing
Announced positive top-line GEMINI-1 Phase 3 clinical trial results of imsidolimab (IL-36R) in generalized pustular psoriasis (GPP) in October 2023
Plan to submit comprehensive data abstract for GEMINI-1 and top-line GEMINI-2 results to a medical meeting in H2 2024
Intend to out-license imsidolimab in 2024
Updates on GSK Immuno-Oncology Financial Collaboration
GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, 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
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
Cash Position
Year end 2023 cash and investments of $417 million and reiterating cash runway through year-end 2026
Fourth Quarter and Full Year 2023 Financial Results
Cash, cash equivalents and investments totaled $417.9 million as of December 31, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $166.3 million. The decrease relates primarily to cash used for operating activities and the $50 million stock repurchase program.
Collaboration revenue was $9.0 million and $17.2 million for the three and twelve months ended December 31, 2023, compared to $6.8 million and $10.3 million for the three and twelve months ended December 31, 2022. The change is due primarily to increased royalties recognized for sales of Jemperli offset by one development milestone achieved for cobolimab in 2022.
Research and development expenses were $33.5 million and $132.3 million for the three and twelve months ended December 31, 2023, compared to $23.4 million and $88.8 million for the three and twelve months ended December 31, 2022. The increase was due primarily to manufacturing and development costs for rosnilimab, ANB032 and ANB033. The R&D non-cash, stock-based compensation expense was $2.5 million and $10.2 million for the three and twelve months ended December 31, 2023 as compared to $1.8 million and $6.8 million in the same period in 2022.
General and administrative expenses were $10.3 million and $41.9 million for the three and twelve months ended December 31, 2023, compared to $9.4 million and $36.6 million for the three and twelve months ended December 31, 2022. The G&A non-cash, stock-based compensation expense was $5.6 million and $23.0 million for the three and twelve months ended December 31, 2023 as compared to $4.9 million and $20.6 million in the same period in 2022.
Acquired in-process research and development of $7.3 million for the three and twelve months ended December 31, 2023 related to the exclusive licensing agreement with Centessa Pharmaceuticals.
Net loss was $42.2 million and $163.6 million for the three and twelve months ended December 31, 2023, or a net loss per share of $1.59 and $6.08, compared to a net loss of $26.4 million and $128.7 million for the three and twelve months ended December 31, 2022, or a net loss per share of $0.93 and $4.57.