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