AnaptysBio (NASDAQ:ANAB) is preparing to separate its business into two entities, with CEO Daniel Faga telling Barclays Senior Biotech Analyst Gena Wang that the company expects to create a new company, First Tracks Biotherapeutics, within “a month or two.” Under the plan, the existing AnaptysBio name will remain with a lean, royalty-based business, while the majority of employees, labs, and development-stage assets will transfer to First Tracks.
Spin-off plan and what stays with AnaptysBio
Faga said the royalty-focused AnaptysBio will retain rights tied to two programs that have already advanced beyond internal development. He cited dostarlimab (Jemperli), a PD-1 antagonist sold by GSK, as one of the company’s “two successful programs so far out of our platform.” He also highlighted imsidolimab, an IL-36 receptor antagonist being developed for generalized pustular psoriasis (GPP), with a phase II readout expected at the end of the year and potential commercialization by Vanda.
Jemperli royalty outlook and key upcoming catalysts
On Jemperli, Faga said GSK entered the current calendar year with a $1.4 billion revenue run rate for the drug, translating to roughly $100 million in royalties for AnaptysBio. He characterized Jemperli as a “very fast-growing” asset with “mid-teens, quarter-over-quarter growth,” driven by ongoing monotherapy development and an existing approval in endometrial cancer.
Looking ahead, he said GSK has guided to sales “far north of” GBP 2 billion (which he equated to $2.7 billion) and that AnaptysBio believes this could be achievable as early as 2029. He also outlined the tiered royalty structure, saying royalties step through tiers of 8%, 12%, 20%, and 25% and could approach $400 million at the $2.7 billion level.
Faga pointed to several clinical and regulatory milestones he expects to influence the drug’s trajectory, including:
- Rectal cancer: GSK has said pivotal results are expected later this year; Faga noted that a phase II study showed a 100% overall response rate.
- pMMR colon cancer: primary completion of a phase II trial is scheduled for this year.
- Additional pivotal studies: he cited ongoing pivotal trials in dMMR colon cancer and head and neck cancer.
Faga also emphasized the duration of intellectual property protection, citing “at least a decade” of composition-of-matter coverage in the U.S., with later expiries in Europe and Japan (into 2037 in Japan). He said GSK is pursuing monotherapy opportunities “where Keytruda doesn’t have data or is not being developed,” which he said supports the long-term outlook.
First Tracks pipeline and capital allocation
In the new biopharma company, First Tracks Biotherapeutics, Faga said the key development programs include ANB033 (a CD122 antagonist), rosanilimab (a PD-1 depleter), and ANB101 (a BDCA-2 modulator).
He said rosanilimab produced positive phase II-B data in arthritis over the past year and that the company is currently evaluating how to proceed into phase III. He said AnaptysBio expects to meet with the FDA during the current quarter and will look for strategic or other financing to fund the program, with an update expected in Q2.
On ANB101, he noted it is in phase I-A and referenced a “proxy program” being developed by Biogen that is in phase III for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).
Discussing funding, Faga said AnaptysBio began the year with $310 million in cash (about $10 per share based on AnaptysBio’s share count), and that a “large portion” will move to First Tracks. He framed the decision as how much of the cash balance to capitalize the new biopharma business with, stating that $100 million would fund operations into Q3 2027, while $200 million would fund the company into the back half of 2028, “dominantly” supporting ANB033. Any capital not transferred to First Tracks would remain at AnaptysBio and could be available for return of capital, including potential share repurchases, he said.
ANB033: celiac disease trial design, competition, and EoE plans
Faga positioned ANB033 as a blocker of IL-2 and IL-15 signaling through CD122, aiming to address inflammatory pathways implicated in celiac disease. He described a phase I-B program with two cohorts. In the first cohort, patients who are well controlled are given a gluten challenge while receiving either ANB033 or placebo, with subcutaneous dosing at baseline and at weeks two and four. The trial includes an endoscopic assessment at week six, measuring mucosal injury via the villous height-to-crypt depth (VHCD) ratio, along with symptom frequency and severity.
The second cohort involves patients who report being well controlled but show evidence of mucosal injury (VHCD ≤ 2) on biopsy. Because a gluten challenge would be unethical in that group, Faga said those patients receive drug or placebo (subcutaneous dosing at baseline, week two, and week four) without gluten administration, and are assessed at week 12 for healing on VHCD. He described this cohort as more representative of a commercially relevant celiac population and said the results are exploratory, with the company looking for a numerical trend rather than statistical significance.
Faga said the company expects phase I-B results in Q4 of this year and plans to engage with the FDA afterward on the fastest path forward. He added that draft FDA guidance calls for a histology endpoint (which he said VHCD would satisfy) and a patient-reported outcome, which the company is measuring with a celiac disease symptom diary.
On competition, Faga cited other celiac programs targeting the IL-15/CD122 pathway, including IL-15 blockers from Teva and Novartis and another CD122 program with positive trending phase I-B results. He said Teva and the CD122 competitor are expected to report phase II-B gluten challenge data later this year, and argued that AnaptysBio’s second, non-gluten-challenge cohort could provide differentiated information to help de-risk later-stage trial design.
For eosinophilic esophagitis (EoE), Faga said the company is initiating a 50-patient, randomized (1:1) trial and expects data in 2027. He said the study is powered for statistical significance on two endpoints: a histology measure of eosinophil infiltration and a patient-reported outcome called DSQ. He contrasted the company’s upstream approach to targeting inflammatory pathways with strategies that target eosinophils directly, and said the trial will enroll both Dupixent-experienced and Dupixent-naïve patients.
Faga said that while the royalty business is designed to “protect and return” value from existing royalties rather than acquire new assets, the company expects to exit the year with two commercial-stage royalty streams. He cited imsidolimab’s PDUFA date of December 12 for GPP and reiterated that the separation is intended to create two businesses with distinct profiles: a high-margin royalty company and a capital-consuming development-stage biopharma.
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.
