Anaptys Reports Q1 2024 Financials and Business Update

AnaptysBio, Inc., a clinical-stage biotechnology company headquartered in San Diego, has announced its financial results for the first quarter ending March 31, 2024, alongside several key business updates.

Under the leadership of President and CEO Daniel Faga, AnaptysBio has been actively enrolling patients in three Phase 2 clinical trials. The trials focus on two pioneering checkpoint agonists: ANB032, targeting BTLA, and rosnilimab, targeting PD-1. Faga emphasized the anticipated release of top-line data for the ANB032 Phase 2b trial in atopic dermatitis by the end of 2024. Additionally, AnaptysBio aims to advance two preclinical immune cell modulators, ANB033 and ANB101, into clinical development within the year.

A significant financial milestone for the company this quarter was the acquisition of $50 million through a capped non-recourse monetization deal of Jemperli royalties from an amended agreement with Sagard. This move is expected to bolster AnaptysBio's financial position. Furthermore, the company shared encouraging data from the Phase 3 program for imsidolimab, which is being developed for generalized pustular psoriasis.

In the detailed pipeline update, AnaptysBio outlined the progress of ANB032 and rosnilimab. The ANB032 Phase 2b trial, which targets moderate-to-severe atopic dermatitis, is progressing with 160 patients enrolled in a placebo-controlled study to assess three dosing levels over 14 weeks, followed by a six-month monitoring period. The primary endpoint has been updated to EASI-75 at Week 14, facilitating more relevant comparisons to existing therapies. Preclinical data presented at recent dermatology and immunology conferences underscored ANB032's potential in modulating dendritic cell function and graft versus host disease.

For rosnilimab, there are ongoing trials targeting rheumatoid arthritis and ulcerative colitis. The rheumatoid arthritis trial involves 420 patients in a placebo-controlled setup to evaluate three dosing levels over 12 weeks, with endpoints including DAS28-CRP, CDAI, and ACR20/50/70. Top-line data is expected by mid-2025. The ulcerative colitis trial includes 130 patients and assesses two dose levels over a 12-week period, with the main endpoints being clinical response and remission. Data from this trial is anticipated by the first half of 2026.

AnaptysBio also plans to submit Investigational New Drug (IND) applications for ANB033, an anti-CD122 antagonist antibody, and ANB101, a BDCA2 modulator antibody, within 2024. These developments are expected to expand its portfolio of immune cell modulators targeting autoimmune and inflammatory diseases.

In terms of legacy programs, AnaptysBio announced positive top-line results from the GEMINI-1 and GEMINI-2 Phase 3 trials for imsidolimab, indicating its safety and efficacy in patients with generalized pustular psoriasis. The company plans to present a comprehensive data abstract at a medical meeting in the second half of 2024 and is looking to out-license imsidolimab later in the year.

Financially, AnaptysBio reported collaboration revenue of $7.2 million for the first quarter of 2024, a significant increase from $1.4 million in the same period the previous year, primarily due to higher royalties from Jemperli sales. Research and development expenses rose to $37.0 million, driven by the development of rosnilimab, ANB032, and ANB033, offset by reduced costs for imsidolimab. General and administrative expenses increased to $12.3 million. The net loss for the quarter was $43.9 million, with a net loss per share of $1.64.

As of March 31, 2024, AnaptysBio had $370.1 million in cash, cash equivalents, and investments, a decrease from $417.9 million at the end of 2023. This decline was primarily attributed to operating expenses and a one-time non-operating payment.

AnaptysBio continues to focus on developing innovative therapeutics in immunology while strategically managing its financial resources to support ongoing and future clinical programs.