Anaptys Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

   -- Announced rosnilimab, a PD-1 depleter and agonist, achieved positive 
      results from Phase 2b rheumatoid arthritis $(RA)$ trial and highest-ever 
      reported CDAI LDA response over 6 months 
 
   -- Full clinical and translational data for rosnilimab in RA in Q2 2025 
 
   -- Top-line Phase 2 data for rosnilimab in ulcerative colitis (UC), moved up 
      to Q4 2025 
 
   -- Phase 1a trial in healthy volunteers ongoing for ANB033, our CD122 
      antagonist, and Phase 1a trial to initiate this quarter for ANB101, our 
      BDCA2 modulator 
 
   -- Announced exclusive global license agreement with Vanda Pharmaceuticals 
      to develop and commercialize imsidolimab, an IL-36R antagonist 
 
   -- Year-end 2024 cash and investments of $420 million and reiterating cash 
      runway through year-end 2027 

SAN DIEGO, Feb. 27, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported financial results for the fourth quarter and year ended December 31, 2024, and provided a business update.

"Rosnilimab's positive Phase 2b data in rheumatoid arthritis has revealed impressive safety, tolerability and three-month efficacy data that was sustained and surpasses six-month data from competitor all-active, head-to-head trials. In Q2 2025, we will report full clinical and translational data, further validating rosnilimab's transformative potential to restore immune homeostasis, not only in RA but also in other diseases like ulcerative colitis. We also are excited to report top-line Phase 2 data for rosnilimab in UC moved up to Q4 2025," said Daniel Faga, president and chief executive officer of Anaptys. "Additionally, Phase 1 development of both ANB033 and ANB101 is advancing as planned. With approximately $420 million of cash coming into 2025, we are well capitalized through year-end 2027, which does not include the significant potential residual royalties and milestones from our GSK financial collaboration."

Updates on Asset Portfolio

Rosnilimab (PD-1 depleter and agonist)

   -- Announced subcutaneously administered rosnilimab, including two 
      once-monthly doses, achieved positive results in 424-patient Phase 2b RA 
      trial and highest-ever reported clinical disease activity index (CDAI) 
      low disease activity (LDA) response over 6 months 
 
          -- Key results for the trial were -- 
 
                 -- Achieved statistical significance on primary endpoint at 
                    Week 12 on mean change from baseline DAS28-CRP score across 
                    all three rosnilimab doses vs. placebo 
 
                 -- Achieved statistical significance on key secondary 
                    endpoints at Week 12 on ACR20, ACR50 and CDAI LDA 
 
                 -- Demonstrated highest-ever reported responses on key 
                    secondary endpoints at Week 14 on ACR20, ACR50, ACR70 and 
                    CDAI LDA 
 
                 -- 69% (220/318) of rosnilimab-treated patients achieved CDAI 
                    LDA at Week 14 and appear to show sustained CDAI LDA and 
                    ACR50 responses and potentially deepening ACR70 responses 
                    out to Week 28 
 
                 -- Robust pharmacological activity observed in reduction of 
                    PD-1high T cells, increase in total Tregs and reduction of 
                    CRP across all doses 
 
                 -- Rosnilimab was safe and well tolerated with similar adverse 
                    event rates vs. placebo 
 
                 -- Full press release can be found here 
 
          -- Full clinical and translational data anticipated in Q2 2025 
 
   -- Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC 
 
          -- 132-patient trial assessing two dose levels of subcutaneously 
             administered rosnilimab vs. placebo (randomized 1:1:1) 
 
                 -- Primary statistical analysis at Week 12 on well-established 
                    endpoints, including the primary endpoint of change from 
                    baseline in modified Mayo score (mMS) and supportive 
                    secondary endpoints of clinical response on mMS, clinical 
                    remission on mMS and endoscopic remission 
 
                 -- All patients in all three study arms treat-through to Week 
                    24 and remain blinded to treatment arm. Placebo-treated 
                    patients who achieved clinical response on partial modified 
                    Mayo score (pmMS) at Week 12 remain on placebo, while 
                    placebo-treated patients who are non-responders are crossed 
                    over to the high-dose rosnilimab treatment arm 
 
                 -- Patients who are in clinical response on pmMS at Week 24 
                    are eligible for an additional 26-weeks (50 weeks of total 
                    treatment), blinded treatment extension period $(TEP)$ 
 
          -- Top-line data anticipated in Q4 2025 
 
   -- Presented preclinical data in Q4 2024 and Q1 2025 (available here) 
      evaluating -- 
 
          -- The PD-1 depletion and agonism mechanisms of rosnilimab in vitro 
             with UC patient-derived PBMCs and a mouse model of colitis at the 
             2024 United European Gastroenterology Week (UEGW) 
 
          -- Inflammatory pathway gene expression in PD-1+ conventional and 
             regulatory T cells in human UC tissue and rosnilimab's effects in 
             a mouse model of colitis at the European Crohn's and Colitis 
             Organisation (ECCO) Congress 
 
          -- Synovial levels of PD-1 and the correlation with disease activity 
             in RA at American College of Rheumatology $(ACR)$ Convergence 

ANB033 (CD122 antagonist)

   -- Enrollment ongoing for Phase 1a trial in healthy volunteers 
 
          -- Phase 1b indication to be disclosed at a 2025 R&D event 

ANB101 (BDCA2 modulator)

   -- Investigational new drug $(IND.AU)$ application accepted by FDA 
 
   -- Phase 1a trial to initiate in healthy volunteers in Q1 2025 

Imsidolimab (IL-36 antagonist)

   -- Announced an exclusive global out-license agreement with Vanda 
      Pharmaceuticals to develop and commercialize imsidolimab (IL-36R 
      antagonist) 
 
          -- Anaptys received $15 million, comprised of a $10 million upfront 
             payment and $5 million for existing drug supply 
 
          -- Anaptys eligible to receive up to $35 million for future 
             regulatory approvals and sales milestones in addition to a 10% 
             royalty on global net sales 

GSK Immuno-Oncology Financial Collaboration

   -- GSK announced strong commercial performance for Jemperli ($190 million in 
      Q4 2024 sales) with >100% year-over-year growth 
 
   -- GSK anticipates top-line data in H1 2025 from COSTAR Lung Phase 3 trial 
      comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 
      antagonist, plus docetaxel to dostarlimab plus docetaxel and to docetaxel 
      alone in patients with advanced NSCLC who have progressed on prior 
      anti-PD-(L)1 therapy and platinum-based chemotherapy 
 
   -- GSK anticipates top-line data in 2026 from AZUR-1 pivotal Phase 2 trial 
      of dostarlimab monotherapy in patients with untreated stage II/III 
      dMMR/MSI-H locally advanced rectal cancer 
 
          -- Jemperli received U.S. FDA Breakthrough Therapy Designation for 
             this indication in December 2024 

Cash Runway

   -- Cash and investments of $420.8 million as of Dec. 31, 2024, and 
      reiterating cash runway through year-end 2027 

Fourth Quarter and Full Year 2024 Financial Results

   -- Cash, cash equivalents and investments totaled $420.8 million as of 
      December 31, 2024, compared to $417.9 million as of December 31, 2023, 
      for an increase of $2.9 million due primarily to the $100 million 
      underwritten registered direct offering completed in Q3 and $50.0 million 
      received from the Sagard royalty monetization in Q2 offset by 2024 
      operating activities. 
 
   -- Collaboration revenue was $43.1 million and $91.3 million for the three 
      and twelve months ended December 31, 2024, compared to $9.0 million and 
      $17.2 million for the three and twelve months ended December 31, 2023. 
      The increase in non-cash revenue in 2024 is due to $15.0 million and 
      $25.0 million commercial milestones earned for annual Jemperli sales 
      exceeding $250.0 million and $500.0 million during the year and increased 
      royalties recognized for sales of Jemperli. For the year ended December 
      31, 2024, GSK reported $598.0 million in sales for Jemperli, a greater 
      than 200% sales growth when compared to $175.6 million for the year ended 
      December 31, 2023. 
 
   -- Research and development expenses were $42.6 million and $163.8 million 
      for the three and twelve months ended December 31, 2024, compared to 
      $33.5 million and $132.3 million for the three and twelve months ended 
      December 31, 2023. The increase was due primarily to development costs 
      for rosnilimab, ANB032, ANB033 and ANB101 offset by a decrease in 
      development costs for imsidolimab. The R&D non-cash, stock-based 
      compensation expense was $3.9 million and $14.8 million for the three and 
      twelve months ended December 31, 2024 as compared to $2.5 million and 
      $10.2 million in the same period in 2023. 
 
   -- General and administrative expenses were $10.2 million and $42.4 million 
      for the three and twelve months ended December 31, 2024, compared to 
      $10.3 million and $41.9 million for the three and twelve months ended 
      December 31, 2023. The G&A non-cash, stock-based compensation expense was 
      $4.3 million and $19.2 million for the three and twelve months ended 

(MORE TO FOLLOW) Dow Jones Newswires

February 27, 2025 16:15 ET (21:15 GMT)