SAN CARLOS, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023. Recent Allakos Events Completed dosing in the single ascending dose (SAD) cohorts and continued dosing in the multiple ascending dose (MAD) cohorts of the randomized, do ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38582 Allakos Inc. (Exact name of Registrant as specified in its Charter) Delaware 45-4798831 (State or other jurisdiction of (I.R.S. ...

– Atopic dermatitis and prurigo nodularis skin lesions show evidence of MRGPRX2 mast cell activation and activated macrophages – – AK006 inhibited mast cell activation and reduced mast cell numbers in an MRGPRX2-induced skin inflammation model – SAN CARLOS, Calif., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (NASDAQ:ALLK), a clinical-stage biotechnology company developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferati ...

–  Data provide insights on the signaling pathways involved with AK006 mast cell inhibition –– AK006 has a distinct mechanism of action that leads to broad inhibitory effects on mast cells – SAN CARLOS, Calif., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (NASDAQ:ALLK), a clinical-stage biotechnology company developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases, today announced the publication of new sci ...

Core Viewpoint - Allakos' shares dropped 60.2% following disappointing results from two mid-stage studies of its lead drug lirentelimab, which failed to meet primary endpoints in treating atopic dermatitis and chronic spontaneous urticaria [1][2]. Group 1: Study Results and Drug Development - Allakos reported top-line data from the phase II ATLAS and phase IIb MAVERICK studies, both of which did not achieve their primary endpoints [2]. - The company has decided to halt further clinical development of lirentelimab and will focus on its early-stage candidate AK006 and other preclinical candidates [2][3]. - Allakos is currently conducting early-stage studies of lirentelimab in healthy volunteers, with dosing expected to complete by the end of the current quarter [4]. Group 2: Financial Impact and Restructuring - Following the decision to terminate lirentelimab, Allakos plans to reduce its workforce by nearly half to cut costs, which is expected to extend its cash runway into mid-2026 [3]. - The company anticipates incurring around $30 million in restructuring costs, primarily before the first half of 2024 [3]. - As of the end of December 2023, Allakos reported a cash and cash equivalents balance of $171 million, with expectations to close 2024 with a balance between $81 million and $86 million [3]. Group 3: Market Performance - Over the past year, Allakos' stock has declined by 85%, contrasting with a 12.2% growth in the industry [2].

Allakos (NASDAQ:ALLK) stock is taking a beating on Tuesday after the clinical stage biopharmaceutical company revealed results from its latest study.The bad news here comes from the company’s Phase 2 and Phase 2b clinical trials of lirentelimab. These trials were evaluating the drug as a treatment for atopic dermatitis (ATLAS) and chronic spontaneous urticaria (MAVERICK).Unfortunately for investors in ALLK stock, neither of the clinical trials was a success. They both failed to meet their primary endpoints. ...

Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Is Allakos Inc. (ALLK) one of those stocks right now? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Allakos Inc. is a member of our Medical group, which includes 1077 different companies and currently sits at #5 in the Zacks Sector Rank. The Zacks Sector Rank gauges the strength of our 16 individual sector ...

Summary of Allakos (ALLK) Conference Call - January 16, 2024 Company Overview - **Company**: Allakos Inc. (Ticker: ALLK) - **Focus**: Development of treatments for chronic spontaneous urticaria (CSU) and atopic dermatitis (AD) using lirintelemab and the new AK006 program Key Points from the Conference Call Clinical Study Results 1. **Atopic Dermatitis Study**: - Phase II study of lirintelemab in moderate to severe atopic dermatitis showed a modest numerical superiority over placebo, but the results were not statistically significant [7][8][12] - 131 subjects were randomized to receive either 300 mg of lirintelemab or placebo every two weeks [6] - Primary endpoint: Proportion of subjects achieving a 75% reduction in EASI score at week 14 [6] - Secondary endpoints included changes in EASI and IGA scores, with no significant differences observed [7][8] 2. **Chronic Spontaneous Urticaria Study**: - Phase II study of lirintelemab in CSU also showed no significant differences in primary efficacy endpoints [13][14] - 127 patients were randomized to receive either 300 mg of lirintelemab or placebo [12] - Primary endpoint: Change in UAS7 score at week 12 [12] - Low placebo response rate was noted, consistent with other CSU studies [13] Financial Update 3. **Restructuring and Cash Management**: - Company announced a restructuring to reduce operating expenses, extending cash runway into mid-2026 [17][20] - Approximately $170 million in cash and investments at the end of 2023 [19] - Anticipated cash burn of $30 million in 2024 due to restructuring, with ongoing operations expected to cost $55 million to $60 million [20] - Plans to avoid raising additional capital until after reporting AK006 top-line data [21] AK006 Program Insights 4. **Comparison with Lirintelemab**: - AK006 targets a different receptor and is considered more potent than lirintelemab [22][23] - AK006 has a longer residence time on the cell surface and induces antibody-dependent cellular phagocytosis (ADCP), which lirintelemab does not [24][28] - Preclinical data suggests AK006 is significantly more effective in inhibiting mast cells compared to lirintelemab [29][30] 5. **Upcoming Milestones**: - Data from healthy volunteers expected in Q2 2024, with top-line data for CSU anticipated by year-end 2024 [20][41] - Phase I studies for AK006 are ongoing, with plans for a Phase II study in CSU to begin in early Q2 2024 [39][41] Market Context and Competitive Landscape 6. **Market Positioning**: - Company remains optimistic about AK006's potential in the CSU market despite competition from other treatments [92] - The evolving treatment landscape includes competitors like Regeneron, but Allakos believes it can offer a cleaner safety profile [92] Additional Considerations 7. **Safety Profile**: - Safety profile of lirintelemab was consistent with previous studies, with injection-related reactions being the most common adverse event [16] - Ongoing studies will further evaluate the safety and efficacy of AK006 in various indications [36][39] 8. **Investor Sentiment**: - Investors expressed concerns regarding the disappointing results from lirintelemab studies, seeking clarity on the potential of AK006 [60][61] - Company emphasized the importance of upcoming data to build confidence in AK006's efficacy [66][68] Conclusion - Allakos is navigating a challenging landscape with its current products while focusing on the promising AK006 program. The restructuring efforts aim to extend financial viability and support ongoing clinical trials, with significant data expected in the near future.

Existing cash to fund planned ongoing operations into mid-2026AK006 is being tested in a comprehensive Phase 1 clinical program, including: ongoing single and multiple ascending dose trial in healthy volunteersa randomized, double-blind, placebo-controlled trial in patients with CSUa subcutaneous AK006 Phase 1 PK and bioavailability trial Management to host conference call and webcast today at 8:00 am E.T. SAN CARLOS, Calif., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (the Company) (NASDAQ:ALLK), a biot ...

– Allakos plans not to pursue further development of lirentelimab; will focus on AK006 clinical development and additional preclinical programs – – Management to host conference call and webcast today at 8:00 am E.T. – SAN CARLOS, Calif., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, today announced topline data from its phase 2 clinical trial in patients with ...