Allakos Provides Business Update and Reports Second Quarter 2023 Financial Results
Recent Allakos Events
- Presented preclinical data at the
European Academy of Allergy and Clinical Immunology(“EAACI”) Hybrid Congress2023 highlighting lirentelimab and AK006 mechanisms of action and inhibitory activity on IgE and non-IgE activated mast cells. Key findings of the presentation included:
- AK006 inhibits IgE mediated mast cell activation and shows similar IgE inhibitory activity as remibrutinib.
- Siglec-6 interacts with mast cell proteins associated with metabolism and signaling that are not seen with Siglec-8.
- AK006 also inhibits non-IgE mast cell activation pathways, including KIT-mediated activation.
- The AK006 Investigational New Drug (“IND”) application was accepted by the
U.S. Food and Drug Administration. The Phase 1, first-in-human, study of AK006 consists of single and multiple ascending doses administered via infusion in healthy adult volunteers. In addition, the Phase 1 study will explore the activity of AK006 in a randomized, double-blind, placebo-controlled cohort of patients with chronic spontaneous urticaria (“CSU”).
Rand Sutherland, M.D. and Dolca Thomas, M.D. to the Allakos Board of Directors.
Upcoming Allakos Anticipated Milestones
- Topline data expected from the Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis in late Q4 2023 to Q1 2024.
- Topline data expected from the Phase 2b study of subcutaneous lirentelimab in patients with CSU in late Q4 2023 to Q1 2024.
- Following the single and multiple ascending dose portions of the Phase 1 AK006 study in healthy volunteers, initiation of the randomized, double-blind, placebo-controlled cohort in patients with CSU is expected in Q2 2024.
Second Quarter 2023 Financial Results
Research and development expenses were
General and administrative expenses were
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos’ progress, business plans and areas of focus, the expected timing of reporting topline data from its Phase 2 and 2b clinical trials of lirentelimab, the clinical potential of Allakos’ antibodies and the initiation of a Phase 1 study of AK006. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos’ stages of clinical drug development; Allakos’ ability to timely initiate and complete clinical trials for lirentelimab and AK006; Allakos’ ability to obtain required regulatory approvals for its clinical trials; uncertainties related to the enrollment of patients in its clinical trials; Allakos’ ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of clinical trials, regardless of the outcomes of preclinical testing or early-stage trials; Allakos’ ability to obtain regulatory approvals to market its product candidates; market acceptance of Allakos’ product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases
UNAUDITED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
|Three Months Ended||Six Months Ended|
|Research and development||$||27,280||$||34,448||$||60,358||$||211,255|
|General and administrative||10,537||14,669||22,505||33,513|
|Total operating expenses||37,817||49,117||82,863||244,768|
|Loss from operations||(37,817||)||(49,117||)||(82,863||)||(244,768||)|
|Other expense, net||—||(90||)||(36||)||(1,545||)|
|Unrealized gain (loss) on investments||(171||)||209||125||(107||)|
|Net loss per common share:|
|Basic and diluted||$||(0.41||)||$||(0.90||)||$||(0.90||)||$||(4.50||)|
|Weighted-average number of common
|Basic and diluted||86,646||54,798||86,246||54,742|
UNAUDITED CONDENSED BALANCE SHEETS
|Cash and cash equivalents||$||67,381||$||87,217|
|Prepaid expenses and other current assets||30,460||29,057|
|Total current assets||251,562||308,843|
|Property and equipment, net||36,446||39,144|
|Operating lease right-of-use assets||24,489||30,225|
|Other long-term assets||6,699||8,208|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||20,177||25,206|
|Total current liabilities||24,484||30,038|
|Operating lease liabilities, net of current portion||39,734||45,949|
|Additional paid-in capital||1,265,350||1,243,408|
|Accumulated other comprehensive loss||(159||)||(284||)|
|Total stockholders’ equity||254,978||310,433|
|Total liabilities and stockholders’ equity||$||319,196||$||386,420|
Source: Allakos Inc.