Rosnilimab

iStock, SvetaZi The business separation, expected to be completed by the end of 2026, will result in two new companies, one focused on biopharma operations and the other on royalty management. AnaptysBio will split its current business into two publicly traded entities: one focused on biopharma operations, including advancing the original company’s clinical pipeline, and the other on royalty management. The business separation, according to analysts at Leerink Partners, will help AnaptysBio crystallize the value of its royalties and highlight the worth of its other assets. “We believe this separation will sharpen investor focus on the company’s asset values by distinguishing between a royalty-backed cash flow vehicle and a clinical-stage pipeline company,” the analysts wrote in an investor note on Tuesday. After the split, much of the work of the royalty-focused company will revolve around Jemperli , GSK’s PD-1 blocker indicated for endometrial cancer and solid tumors. Jemperli was discovered by AnaptysBio, which licensed it out to TESARO in March 2014 under a worldwide immuno-oncology antibody partnership. GSK acquired TESARO in December 2018 for $5.1 billion . According to AnaptysBio’s Tuesday release, GSK has maintained a guidance of around $2.7 billion in peak Jemperli sales and has continued to assess the drug in other indications, including rectal cancer, colon cancer and head-and-neck squamous cell carcinoma. The royalty arrangement over Jemperli will extend “at least through expiration” of related patents, according to AnaptysBio’s statement. The royalty entity will also manage payments from Vanda Pharmaceuticals for the IL-36 receptor inhibitor imsidolimab, being developed for generalized pustular psoriasis under a February 2025 contract . This new royalty spinout will be eligible for $35 million in milestone payments plus a 10% royalty on net sales, according to AnaptysBio. Meanwhile, the resulting biopharma company will be dedicated to the development of its CD122 antagonist ANB033, being tested in a Phase Ib trial for celiac disease, and the BDCA2 modulator ANB101, which is currently being studied in healthy volunteers in a Phase Ia trial. At its launch, this new biopharma spinout will have enough money to keep it running for “at least two years,” the release stated. Leading this new entity’s pipeline is the T cell depleter rosnilimab, which in May this year cleared the Phase IIb RENOIR study in rheumatoid arthritis. The asset is currently in a Phase IIb trial of ulcerative colitis, with data expected by the end of the year. AnaptysBio is currently reviewing its strategic options for rosnilimab, the company said on Tuesday, the results of which will determine how the value of the asset will be allocated between the two companies. AnaptysBio has yet to disclose names for these two new entities, though current CEO Daniel Faga will lead the biopharma spinout. The company expects to complete this business split by the end of 2026.

The as-yet-unnamed, royalty-focused company will have “minimal infrastructure and staff,\" AnaptysBio said.\n AnaptysBio plans to split into two publicly traded companies, with one entity taking forward the biopharma’s clinical-stage pipeline and the other overseeing its royalty-based agreements.The crown jewel of the royalty-focused business will be payments related to Jemperli, the PD-1 blocking antibody that Anaptys discovered and has since brought its current owner GSK $2.7 billion in sales as an endometrial cancer and solid tumor drug. The pharma giant previously agreed to hand over 8% in royalties for Jemperli sales up to the first $1 billion, then 12% on sales between $1 billion and $1.5 billion, 20% of sales between $1.5 billion and $2 billion and 25% of sales above the $2.5 billion mark.However, Anaptys already monetized a portion of these potential royalties, meaning asset management firm Sagard gets the first $600 million in royalties the biotech had originally been owed. Anaptys calculates that Sagard will have received its full share at some point between mid-2027 and the second quarter of 2028.Another potential source of revenue for the royalties-focused spinoff is imsidolimab, a phase-3-stage pustular psoriasis drug Anaptys licensed to Vanda Pharmaceuticals for $10 million upfront earlier this year. The royalties company could be in line for up to $35 million in milestones if imsidolimab makes it all the way to market, on top of a 10% slice of net sales.The as-yet-unnamed, royalty-focused company will have “minimal infrastructure and staff,” Anaptys suggested in a Sept. 29 release.The split will leave San Diego-based Anaptys’ current pipeline in the hands of another, as-yet-unnamed company that will be headed up by the biopharma’s current CEO Daniel Faga. The pipeline will be led by rosnilimab, a PD-1 agonist that hit the goals of a phase 2 rheumatoid arthritis trial back in February. There is also ANB033, a CD122 antagonist undergoing a phase 1 study for celiac disease, as well as a phase 1-stage BDCA2 modulator called ANB101 that’s being targeted at autoimmune and inflammatory diseases.The separation of the two companies is expected to be complete by the end of 2026, with the biopharma business then armed with enough capital to keep it afloat for two years.“Anaptys is strategically positioned with multiple attractive, high-potential assets, including our development-stage pipeline consisting of rosnilimab, ANB033 and ANB101, as well as substantial potential royalties and milestone payments from our ongoing financial collaborations with GSK and Vanda,” Faga said in yesterday’s postmarket release.“In parallel with assessing multiple strategic options for rosnilimab in RA or UC, including securing a global partnership to help advance development in all indications or advancing in one phase 3 indication independently, today’s announcement to explore a separation of our wholly owned biopharma programs from our royalty assets is intended to provide investors with the opportunity to realize and enhance the potential value of two distinct sets of assets,” the CEO explained.