AnaptysBio Details Plan to Split Into RoyaltyCo and Biopharma at TD Cowen Healthcare Conference
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He also pointed to upcoming data catalysts for GSK, including survival data from a pivotal rectal cancer trial this year, and referenced additional readouts including a phase 2 dMMR colon cancer dataset expected before year-end based on ClinicalTrials.gov, along with ongoing pivotal trials in dMMR colon cancer and head and neck cancer.
On imsidolimab, Faga said partner Vanda filed a BLA in December and now has a PDUFA date in December of this year, which he said could position the royalty company to end the year with a second commercial-stage royalty asset.
Capital allocation and management expectations
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Faga said AnaptysBio entered the year with $310 million in cash. He suggested the royalty business would require limited cash, stating that about $20 million would provide sufficient runway. He said the royalty company is expected to be GAAP positive “out of the gate” and cash-flow positive in the back half of 2027.
For the biopharma company, he described funding scenarios tied to ANB033’s development:
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~$100 million of cash could fund operations into the back half of 2027 and support ANB033 through phase 2 trials in celiac disease and eosinophilic esophagitis (EoE), assuming success.
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~$200 million could extend runway into the back half of 2028 and support additional phase 2 trial starts.
Faga said the final cash split is still being evaluated and is “one of the last things” to be resolved. He also noted the company repurchased more than 11% of its stock as part of its view that an “arbitrage” remained between the value of the Jemperli royalty stream and the company’s overall valuation.
On governance, Faga said the biopharma company’s board will be a “super majority subset” of the current board, and that he will run the biopharma business. He said the company has not yet announced the royalty business board and management structure, adding that it would not require a large management team.
GSK litigation focused on combination-development obligations
Faga addressed an ongoing dispute with GSK, emphasizing that the separation is unrelated to the litigation and that the dispute does not concern GSK’s monotherapy development of Jemperli. He said AnaptysBio’s claims relate to what it views as GSK’s breach of contractual obligations in combination development, including exclusivity obligations to develop only with Jemperli as the PD-1, disclosure obligations, and an obligation to drive “optimal commercial return.”
He said GSK filed litigation in November alleging AnaptysBio was repudiating the contract, and that AnaptysBio subsequently filed suit. He said the matter is scheduled for trial in Delaware Chancery Court on July 14.
Biopharma pipeline: rosnilimab, ANB033, and ANB101
On rosnilimab in rheumatoid arthritis (RA), Faga cited data from a phase 2b study showing statistical significance at three months, deepening response through six months, and persistence off drug through nine months. He described it as the first drug to show disease modification in RA “in well over a decade” and said the company plans to meet with the FDA in a phase II meeting in Q1 to define phase 3 parameters and costs. He reiterated the company does not intend to commercialize RA alone and does not plan to fund a phase 3 program using cash earmarked for ANB033, indicating partnering would be required.
For ANB033, Faga detailed the rationale for targeting CD122 to block IL-15 and IL-2 signaling, aiming to address inflammation in celiac disease by targeting intraepithelial lymphocytes and related immune pathways. He said AnaptysBio is running two celiac cohorts: a gluten challenge study designed to assess prevention of villous damage and symptom worsening versus placebo, and a second cohort in patients with more extensive villous destruction who are treated without gluten challenge to evaluate mucosal healing via the villous height-to-crypt depth (VHCD) ratio. He said the company expects to report both datasets by Q4 of this year.
Faga said the gluten challenge study is a 30-patient, 1:1 randomized trial powered to detect differences versus placebo on VHCD and symptom scores. For the mucosal healing cohort, he described the readout as more exploratory, with the goal of seeing directional or numerical improvement in VHCD at 12 weeks.
Discussing commercial opportunity, Faga estimated more than 2 million people in the U.S. have celiac disease, with about 1 million diagnosed by biopsy, and said roughly 250,000 diagnosed patients are non-responsive to a gluten-free diet and still have villous damage—an initial target population for therapy.
He also described EoE as a second planned indication for ANB033, citing human data from an IL-15 targeting agent showing reduced eosinophil recruitment via effects on CD8 cells, and arguing CD122 antagonism could address both CD8-driven pathways and TH2/ILC2-related inflammation. He noted dupilumab is the only approved therapeutic in EoE and said up to 30% of patients do not respond, with non-response associated in part with increased IL-15.
Finally, on ANB101 (BDCA-2 modulation), Faga said the company is conducting a phase 1A healthy volunteer study to evaluate pharmacokinetics and pharmacodynamic effects, including half-life and a “long-term PD effect” related to plasmacytoid dendritic cell depletion. He referenced Biogen’s ongoing phase 3 program in systemic lupus erythematosus and cutaneous lupus, with readouts expected later this year, and said AnaptysBio’s goal is to position ANB101 as a differentiated candidate against an established clinical benchmark.
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.
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