Allakos (ALLK) Announces Restructuring to Focus on Development of AK006

Allakos Inc. (the Company) (Nasdaq: ALLK), a biotechnology company developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, today announced a restructuring to reduce costs and to focus on AK006 clinical development and additional preclinical programs. As a result, the Company’s cash runway is expected to extend into mid-2026.

Restructuring Activities
The Company will halt lirentelimab-related activities across clinical, manufacturing, research and administrative functions. As a result, the Company will reduce its workforce by approximately 50%.

Cash Guidance
The Company ended the fourth quarter of 2023 with approximately $171 million in cash, cash equivalents and investments (unaudited). The Company’s outlook for 2024 cash, cash equivalents and investments is as follows:

Components of estimated 2024 net cash used in operating activities for the year ended December 31, 2024 are as follows:

¹ The Company anticipates that the significant majority of the restructuring expenditures will be paid in the first half of 2024.

The Company expects that the restructuring activities will extend the cash runway into mid-2026.

Anticipated Allakos Milestones

• Q1 2024: Complete dosing in the single ascending dose (SAD) and multiple ascending dose (MAD) cohorts of the randomized, double-blind, placebo-controlled Phase 1 trial of Intravenous (IV) AK006 in healthy volunteers.
• Q1 2024: Initiate the randomized, double-blind, placebo-controlled subcutaneous (SC) AK006 cohort in healthy volunteers.
• Q2 2024: Report SAD and MAD safety, pharmacokinetics (PK), and pharmacodynamic (PD) results from the Phase 1 IV AK006 trial in healthy volunteers, including data to confirm Siglec-6 receptor occupancy in skin biopsy samples.
• Q2 2024: Initiate the randomized, double-blind, placebo-controlled Phase 1 trial of IV AK006 in patients with chronic spontaneous urticaria (CSU).
• Q3 2024: Report subcutaneous (SC) AK006 safety, PK, and PD results from the Phase 1 trial in healthy volunteers, including data to confirm Siglec-6 receptor occupancy in skin biopsy samples.
• Year End 2024: Report topline data from the Phase 1 trial of IV AK006 in patients with CSU.

About Siglec-6 and AK006

Siglec-6 is a member of the family of cell surface receptors called Sialic acid-binding immunoglobulin-type lectins (Siglecs). Siglec-6 is found on the surface of mature mast cells, and therefore offers a way to target mast cells. Siglec-6 exerts inhibition through its intracellular immunoreceptor tyrosine-based motif (ITIM).

ITIM bearing receptors antagonize activating receptors and consequently have important roles in regulating the immune system. The inhibitory function is derived from the ability of the ITIMs to recruit SH2 domain-containing phosphatases which work to oppose activating signals driven by kinase signaling cascades. Disrupting kinase signaling cascades has been a successful strategy for treating inflammatory diseases as evidenced by approved drugs which target JAK, KIT, BTK, SYK, and others. However, often these kinase signaling pathways are active in multiple cell types, which can result in unintended side effects when disrupted.

AK006 is a humanized IgG1 monoclonal antibody which activates the inhibitory receptor Siglec-6. AK006 is directed to an extracellular epitope of the Siglec-6 receptor that was identified for its ability to generate strong inhibitory signals to mast cells. Furthermore, AK006 was engineered to have higher cell surface residence time which may increase mast cell inhibition. In addition to inhibition, in preclinical studies AK006 reduces mast cell numbers via antibody-dependent cellular phagocytosis (ADCP) in the presence of activated macrophages.

Conference Call and Webcast Information
The webcast and conference call will take place at 8:00 am ET / 5:00 am PT on January 16^th, 2024. Please click here to pre-register to participate in the conference call and obtain your dial in number and PIN.

A webcast of the live call will be available online in the investor relations section of the Allakos website. Access to the webcast replay will be available approximately two hours after completion of the call and will be archived on the Company’s website for approximately 30 days.

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