AK006 Phase 1 CSU Study Results & Business Update January 27, 2025 Exhibit 99.1
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Agenda Robert Alexander, CEO Introduction Chin Lee, CMO AK006 Phase 1 CSU Study Results Baird Radford, CFO Restructuring and Financial Implications Q&A
Phase 1 Study of AK006 in Chronic Spontaneous Urticaria
AK006 Phase 1 Chronic Spontaneous Urticaria Study Multi-center, randomized, double-blind, placebo-controlled study in CSU Diagnosis of CSU refractory to antihistamines Presence of itch and hives despite current use of antihistamines UAS7 score ≥16 and HSS7 score ≥8 at baseline Includes patients with prior biologics treatment Interim: 34 adult patients (2:1 randomization) IV infusions of 720 mg AK006 Q4W Placebo Subjects in interim analysis enrolled from 14 sites in the US and Canada Primary Endpoint Safety & tolerability Exploratory Efficacy Analysis Clinical activity assessed by changes in UAS7 at week 14 Proportion of patients achieving UAS7=0 Study Design Endpoints
Baseline Demographics & Patient Characteristics Baseline Characteristics (mITT population) Phase 1 (CSU Cohort) Patient Characteristics AK006 n=23 Placebo n=11 All n=34 Age, mean ± SD 43 ± 14 45 ± 13 44 ± 13 Female sex, n (%) 19 (83%) 8 (73%) 27 (79%) White, n (%) 19 (83%) 7 (64%) 26 (76%) From US sites, n (%) 16 (70%) 7 (64%) 23 (68%) BMI (kg/m2), mean ± SD 27.7 ± 2.3 27.7 ± 3.0 27.7 ± 2.5 Duration of CSU diagnosis (years), median (range) 4.5 (0.9 - 40.7) 6.5 (0.9 - 37.7) 5.2 (0.9 - 40.7) Prior omalizumab use, n (%) 5 (22%) 3 (27%) 8 (24%) Peripheral blood eosinophils (cells/µL), median (range) 90 (30 - 680) 110 (30 - 290) 90 (30 - 680) IgE (kU/L), median (range) 129 (5 - 8026) 119 (6 - 1539) 124 (5 - 8026) Baseline UAS7 [0-42], mean ± SD 34.4 ± 5.9 30.5 ± 5.9 33.1 ± 6.1 Baseline UAS7 28-42, n (%) 18 (78%) 9 (82%) 27 (79%)
CSU Cohort Efficacy Results UAS7 score is a Patient Reported Outcome questionnaire assessing itch severity and number of hives. Total range: 0 - 42 with higher scores denoting greater disease activity. Key Efficacy Endpoints (mITT population) AK006 n=23 Placebo n=11 UAS7 at Baseline, mean ± SD 34.4 ± 5.9 30.5 ± 5.9 UAS7 Change from BL at Week 14, LS Mean -8.2 (95% CI: -13.1, -3.2) -12.4 (95% CI: -18.7, -6.1) Proportion of Patients Achieving UAS7=0 at Week 14, % (n) 8.7% (2) 9.1% (1)
AK006 Was Well-Tolerated with a Favorable Safety Profile TEAEs occurring in at least two AK006-treated subjects, n (%) AK006 (n=23) Placebo (n=11) Headache 2 (8.7%) 1 (9.1%) Infusion related reaction 2 (8.7%) 0 COVID-19 2 (8.7%) 0
Business Update
Restructuring Activities and Planned Actions The Company plans to discontinue AK006-related activities across clinical, manufacturing, research and administrative functions and reduce its workforce by approximately 75%. The Company plans to retain approximately 15 employees to explore strategic alternatives, maintain compliance with regulatory and financial reporting requirements, and wind-down the phase 1 clinical study.
Cash Guidance The Company ended the fourth quarter of 2024 with approximately $81 million in cash, cash equivalents, and investments (unaudited). The Company estimates that cash used in restructuring activities to closeout AK006 development, including severance and contractual payments to vendors will be approximately $34 million to $38 million. The Company also estimates that a significant majority of these restructuring costs will be paid over the first and second quarters of 2025. The Company estimates it will have cash, cash equivalents and investments in a range of approximately $35 million to $40 million at June 30, 2025.
Q&A Confidential
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