AnaptysBio (NASDAQ:ANAB) leadership outlined plans to separate its royalty business from its clinical-stage biopharma operations, while also discussing key revenue drivers tied to GSK’s Jemperli, pipeline priorities led by ANB033 in celiac disease and eosinophilic esophagitis (EoE), and upcoming catalysts spanning regulatory, clinical, and legal developments.
Planned separation of royalty and biopharma businesses
Management said its top near-term priority is completing the separation of the royalty company from the biopharma company. The company reiterated that it is targeting completion sometime in Q2, but cautioned that it is not expected to occur at the start of April and timing could move later.
The separation is expected to be a taxable spin and the new biopharma business is expected to be a publicly traded entity at launch. Management said it expects “almost all employees” to move into the biopharma company and confirmed that the executive speaking will run the biopharma entity.
Cash allocation decision tied to the spin
Management said the company entered the year with $310 million in cash (which it described as about $11 per share). It said it intends to capitalize the biopharma company with at least enough cash to reach key data catalysts in celiac disease and EoE “in through 2027,” and noted that allocating all cash to the biopharma company would extend runway “well into 2028.”
At the same time, management said there is a decision point around how much cash to leave behind at the royalty company, including the possibility of returning capital to shareholders, potentially through share repurchases. The company framed the decision as linked to the timing of when the spin becomes effective and ongoing spending, which it said is currently largely supporting the biopharma business.
Jemperli royalties and key clinical/regulatory catalysts
Management highlighted what it described as substantial royalties driven by Jemperli and potential future royalties tied to imsidolimab. It emphasized the growth of Jemperli and argued the market may be underappreciating its trajectory.
On recent performance, management referenced Jemperli’s Q4 sales of $343 million and described growth as mid-teens quarter over quarter. It also said GSK has guided to $2.7 billion peak sales for Jemperli. Management discussed several points it believes support continued expansion, including its characterization of Jemperli as a “best-in-class PD-1 antagonist,” along with ongoing monotherapy development and label expansion efforts.
Near-term Jemperli-related catalysts cited included:
- dMMR rectal cancer pivotal trial readout expected this year; management noted use of a priority voucher that could enable a one- to two-month U.S. approval timeline.
- Phase II data in MSI-H colon cancer expected this year, which management suggested is not broadly reflected in current valuation models.
Management said AnaptysBio’s royalty rate on Jemperli is 8% to 25%.
ANB033: celiac disease study progress and Q4 data target
Management spent significant time on ANB033, describing it as a CD122 antagonist that blocks signaling of both IL-15 and IL-2. It said the program is differentiated in part because it is in the clinic with subcutaneous administration and is designed to address multiple components of celiac disease biology, including effects on CD8 and CD4 immune cells.
For celiac disease, management described a market opportunity it believes is large, citing more than 2 million patients in the U.S. and noting there are currently no approved therapeutics. It said enrollment began in Q4 of last year and that it expects to read out data in Q4 of this year.
The company outlined two cohorts in its celiac study:
- Gluten challenge cohort (30 patients, 1:1 randomization): subcutaneous dosing at weeks 0, 2, and 4, followed by 14 days of daily gluten and biopsy at week 6. Endpoints include a histology measure (villous height-to-crypt depth ratio, VHCD), intraepithelial lymphocytes (IELs), and a validated patient-reported outcome (Celiac Disease Symptom Diary, CD-SD).
- Damaged villi cohort (patients with VHCD < 2): dosing at weeks 0, 2, and 4 with biopsy at week 12, looking for improvement in healing; management said it is powered but expects to look for a trend given uncertainty about the time needed to show separation.
Management said there is no established “threshold” for what constitutes clinically meaningful VHCD improvement and emphasized alignment between histology improvement and patient symptoms as key, consistent with draft FDA guidance referencing histology and PRO endpoints.
EoE program timeline, endpoints, and rosnilimab/ANB101 updates
Management said the EoE study is expected to begin this quarter, with sites being initiated and enrollment anticipated before quarter end. It added that EoE data is not expected until 2027, and that it plans to provide more protocol detail after initiation.
The company said the EoE Phase 1b study is designed to be powered for two primary endpoints: reduction in eosinophils and improvement on a PRO (the Dysphagia Symptom Questionnaire, DSQ), the same PRO used in dupilumab’s approval. Management framed this as a strategy to reduce risk given prior failures of drugs that reduced eosinophils but did not improve symptoms.
On rosnilimab, management reiterated it believes the drug performed well in a Phase 2b rheumatoid arthritis study, describing data that improved over time and remained stable off drug for up to nine months in a 424-patient trial. The company said it does not plan to advance rosnilimab using balance sheet cash and does not expect to commercialize it itself. It expects to complete an end-of-Phase 2 FDA meeting by the end of the quarter, which it said should clarify program size and safety database requirements, and it plans to provide an update later in the first half of the year.
For ANB101 (a BDCA2 modulator in Phase 1a), management said it is closely watching Biogen’s ongoing Phase 3 trials in SLE, expected to read out by the end of this year, and a CLE program with readout timing discussed as early 2027. Management said internal preclinical and early Phase 1a observations suggest a more potent, extended half-life profile and stronger pharmacodynamic depletion of plasmacytoid dendritic cells, but that future development direction will depend on Biogen’s results.
Finally, management noted ongoing litigation with GSK over alleged contractual breaches related to combination development. It said a trial is set for July and suggested the outcome could be a catalyst over the coming months, including the possibility that rights could revert back to the royalty business after the trial.
About AnaptysBio (NASDAQ:ANAB)
AnaptysBio, Inc is a clinical-stage biotechnology company focused on the discovery and development of therapeutic antibody product candidates in immunology and inflammation. Founded in 2012 and headquartered in San Diego, California, AnaptysBio leverages a proprietary somatic hypermutation platform to rapidly generate and refine human antibodies with optimized efficacy and safety profiles. The company’s technology is designed to accelerate target validation and candidate selection across a range of immune-mediated conditions.
The company’s pipeline includes multiple clinical-stage programs addressing dermatological and inflammatory disorders.
