AnaptysBio Gears Up For Key Trial Readouts In Rheumatoid Arthritis And Lung Cancer

AnaptysBio

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(RTTNews) - Shares of AnaptysBio Inc. (ANAB) are down over 50% from their 52-week high of $41.31, recorded last August, with the stock now hovering around the $20 level.

This clinical-stage biotechnology company is developing immunology therapeutics for autoimmune and inflammatory diseases. Its lead drug candidate is Rosnilimab, which is in a phase IIb trial for the treatment of rheumatoid arthritis and in a phase II trial for the treatment of ulcerative colitis.

In February of this year, the company announced statistically significant Week-12 data from its phase IIb trial of Rosnilimab for moderate-to-severe rheumatoid arthritis, dubbed RENOIR.

According to the trial results, Rosnilimab helped reduce symptoms in people with moderate-to-severe rheumatoid arthritis, and by Week 14, many patients had much lower disease activity.

Rosnilimab caused a rapid and sustained reduction of about 90% in a specific type of immune cells called PD-1high T cells while increasing the total number of Tregs (a type of immune cell that helps control the immune system). This led to a more balanced and healthy immune cell makeup, helping the body return to a state of immune homeostasis (a balanced immune system). Additionally, there was a significant drop in C-reactive protein (CRP), a marker of inflammation, across all doses, showing that the treatment helps reduce inflammation in the body.

The company expects to report full clinical and translational data for Rosnilimab in rheumatoid arthritis this quarter (Q2, 2025).

In the global phase II trial in moderate-to-severe ulcerative colitis, two dose levels of subcutaneously administered Rosnilimab are being tested against placebo, and topline data are anticipated in Q4 2025.

The other investigational drugs in the pipeline are ANB033 and ANB101, being developed for the treatment of autoimmune and inflammatory diseases.

-- A phase Ia trial of ANB033 in healthy volunteers is underway, and the indication for the phase Ib trial is expected to be disclosed at a 2025 R&D event.

-- ANB101 is expected to advance into a phase Ia trial in healthy volunteers soon.

Licensing Agreements & Collaborations

AnaptysBio has an immuno-oncology-focused collaboration with GSK plc (GSK).

The most advanced partnered program under the GSK collaboration is Dostarlimab, sold under the brand name Jemperli, for the treatment of endometrial cancer. For the year ended December 31, 2024, GSK reported $598.0 million in sales for Jemperli, compared to $175.6 million for the year ended December 31, 2023. AnaptysBio receives milestones and tiered royalties from GSK on net sales of Jemperli.

As part of the collaboration, GSK is also developing Dostarlimab in combination with another investigational therapy from the agreement, including Cobolimab, a TIM-3 antibody.

A phase III clinical trial evaluating the combination of Cobolimab, Dostarlimab, and Docetaxel in patients with advanced non-small-cell lung cancer who have progressed on prior anti-PD-(L)1 therapy and chemotherapy, known as COSTAR Lung, is being conducted by GSK. Top-line results from the study are expected in the first half of 2025.

On January 31, 2025, AnaptysBio entered into an Exclusive License Agreement with Vanda Pharmaceuticals Inc. (VNDA), granting Vanda an exclusive, global license for the development and commercialization of Imsidolimab. This compound is being evaluated in two global phase III trials in patients with Generalized Pustular Psoriasis, dubbed GEMINI-1 and GEMINI-2.

AnaptysBio is eligible to receive up to $35.0 million for future regulatory approval and sales milestones in addition to a 10% royalty on net sales.

Financial Numbers

AnaptysBio significantly narrowed its annual net loss in 2024 to $145.2 million, or $5.12 per share, from $163.6 million, or $6.08 per share, in 2023. Collaboration revenue jumped to $91.3 million in 2024, up from $17.2 million the previous year.

As of December 31, 2024, the company held $420 million in cash, which is expected to be sufficient to fund operations through the end of 2027.

AnaptysBio shares began trading on the NASDAQ Global Select Market on January 26, 2017, under the symbol "ANAB", priced at $15 per share.

In the last 1 year, ANAB has traded in a range of $12.21 to $41.31. The stock closed yesterday's trading at $20.70, up 0.44%.