Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by officers and directors of Allakos Inc. related to self-dealing, which may entitle shareholders to damages and corporate governance reforms [1]. Group 1 - The investigation focuses on whether certain officers and directors of Allakos Inc. have engaged in self-dealing that could harm shareholder interests [1]. - Shareholders are encouraged to contact Kuehn Law for a free consultation regarding their rights and potential claims [2]. - The firm emphasizes the importance of shareholder participation in maintaining the integrity and fairness of financial markets [3].

Core Viewpoint - Allakos Inc. (ALLK) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, particularly influenced by institutional investors who adjust their valuations based on these estimates [4][6]. - Rising earnings estimates for Allakos suggest an improvement in the company's underlying business, which could lead to an increase in stock price as investors respond positively [5][10]. Earnings Estimate Revisions - For the fiscal year ending December 2024, Allakos is expected to report earnings of -$1.47 per share, reflecting a year-over-year change of 31.3% [8]. - Over the past three months, the Zacks Consensus Estimate for Allakos has increased by 4.1%, indicating a positive trend in analyst expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating, highlighting their potential for market-beating returns [9][10]. - Allakos's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a favorable outlook for the stock in the near term [10].

Scientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s Disclosure: I/we have a beneficial long position in the shares of ALLK either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than f ...

Clinical Development - AK006 is currently in a Phase 1 clinical trial, with positive results reported for both intravenous and subcutaneous formulations, demonstrating high receptor occupancy and favorable safety profiles[65] - The company expects to report initial data from over 30 subjects with chronic spontaneous urticaria (CSU) in early Q1 of 2025, addressing a significant unmet medical need[65] - AK006 targets Siglec-6, an inhibitory receptor on mast cells, with the potential to treat a broad population of CSU patients[65] - The subcutaneous formulation of AK006 showed bioavailability of 77% and an estimated half-life of 12-22 days[67] - The company has halted development of lirentelimab following Phase 2 results, focusing resources on AK006 and other product candidates[67] Financial Performance - As of September 30, 2024, the company reported a net loss of $116.2 million for the nine months ended September 30, 2024, compared to $123.2 million for the same period in 2023, with an accumulated deficit of $1,234.7 million[67] - Net loss for Q3 2024 was $18.4 million, compared to a net loss of $45.6 million in Q3 2023, a reduction of 59.6%[89] - Total operating expenses for the nine months ended September 30, 2024 were $121.5 million, compared to $131.1 million for the same period in 2023, a decrease of 7.3%[90] - Research and development expenses were $10.9 million for Q3 2024, down from $36.7 million in Q3 2023, representing a decrease of 70.3%[84] - General and administrative expenses decreased to $8.9 million in Q3 2024 from $11.5 million in Q3 2023, a reduction of 22.6%[85] Cash and Funding - The company has cash, cash equivalents, and investments totaling $92.7 million, which is expected to fund operations for at least the next 12 months[67] - Cash, cash equivalents, and investments totaled $92.7 million as of September 30, 2024, sufficient to fund operations for at least the next 12 months[96] - Net cash used in operating activities was $81.1 million for the nine months ended September 30, 2024, compared to $92.2 million for the same period in 2023, a decrease of 12.1%[99] - The company recorded $5.3 million in interest income for the nine months ended September 30, 2024, down from $8.0 million in 2023, a decrease of 33.8%[94] - Interest income decreased to $1.4 million in Q3 2024 from $2.6 million in Q3 2023, a decline of 46.2%[87] - The company intends to seek additional funding through private or public equity or debt financings, or strategic collaborations[104] - Future equity or debt financings may impose unfavorable terms, potentially restricting operations and limiting financial flexibility[103] - The company has filed a new shelf registration statement allowing for the sale of up to $250.0 million of common stock, effective November 24, 2023[96] Operational Changes - The 2024 Reorganization Plan was implemented to reduce operating costs, resulting in a workforce reduction of approximately 50%[67] - Research and development expenses are expected to decrease in the second half of 2024 compared to the first half, due to reduced expenses related to lirentelimab and the reorganization plan[72] - The company may be required to delay or reduce operations if unable to raise additional funds when needed[104] - The timing and amount of capital expenditures will depend on various factors, including clinical trials and regulatory reviews[104] - The company expects to enter into additional collaborative research and manufacturing agreements, which may require significant upfront payments[105] Contractual Obligations - Contractual obligations primarily relate to operating leases and non-cancelable purchase obligations with research and development organizations[105] - The company has not entered into any off-balance sheet arrangements since inception[106] - As a smaller reporting company, the company is not required to provide market risk disclosures[107]

Financial Performance - Allakos reported a net loss of $18.4 million for Q3 2024, a significant decrease from the $45.6 million loss in Q3 2023, resulting in a net loss per share of $0.21 compared to $0.52 in the prior year[6]. - Total operating expenses for Q3 2024 were $19.8 million, down from $48.2 million in Q3 2023[10]. Research and Development - Research and development expenses decreased to $10.9 million in Q3 2024 from $36.7 million in Q3 2023, a reduction of $25.8 million attributed to halting the lirentelimab development program[6]. - The Phase 1 trial of intravenous AK006 for chronic spontaneous urticaria has completed enrollment of over 30 patients, with data expected in early Q1 2025[2][3]. - The bioavailability of subcutaneous AK006 was approximately 77%, with a half-life of 12-22 days, indicating potential for infrequent dosing[2]. Cash and Investments - Allakos ended Q3 2024 with $92.7 million in cash, cash equivalents, and investments, reflecting a net decrease of $30.4 million during the quarter, with approximately $18 million related to exiting the lirentelimab program[5]. - The company expects to end 2024 with total cash, cash equivalents, and investments in the range of $81 to $86 million, extending its cash runway into mid-2026[4]. General and Administrative Expenses - General and administrative expenses decreased to $8.9 million in Q3 2024 from $11.5 million in Q3 2023, a reduction of $2.6 million[6]. Asset Management - Allakos' total assets decreased to $124.4 million as of September 30, 2024, down from $243.6 million at the end of 2023[11]. - The company has substantially completed its exit from the lirentelimab development program, which contributed to the reduction in expenses[4].

SAN CARLOS, Calif., Nov. 06, 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 third quarter ended September 30, 2024. Recent Allakos Events Reported safety, pharmacokinetics (PK), and pharmacodynamic (PD) results from the Phase 1 trial of subcutaneous (SC) AK006 in healthy volunteers. Bioavailability ...

– Subcutaneously administered AK006 showed approximately 77% bioavailability and prolonged receptor occupancy on mast cells –– Subcutaneous AK006 was well-tolerated with a favorable safety profile –– Top-line Phase 1 results of Intravenous AK006 in patients with CSU are expected in early Q1 of 2025 – SAN CARLOS, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a biotechnology company developing AK006 for the treatment of mast cell-driven diseases, today announced results from the Phase ...

Financial Performance - The company reported net losses of $97.8 million and $77.5 million for the six months ended June 30, 2024, and 2023, respectively, with an accumulated deficit of $1,216.3 million as of June 30, 2024[81]. - Net loss for Q2 2024 was $26.7 million, an improvement from a net loss of $35.1 million in Q2 2023, representing a 23.5% reduction[103]. - Comprehensive loss for the six months ended June 30, 2024 was $97.9 million, compared to $77.4 million for the same period in 2023, an increase of 26.5%[105]. - The company has not generated any revenue from product sales and does not expect to do so for at least the next several years[82]. Operating Expenses - Operating expenses are classified into research and development and general and administrative, with significant costs incurred for clinical studies and manufacturing[83]. - Total operating expenses for the six months ended June 30, 2024 were $101.7 million, compared to $82.9 million for the same period in 2023, an increase of 22.7%[105]. - General and administrative expenses decreased to $9.2 million for Q2 2024 from $10.5 million in Q2 2023, a reduction of 12.6%[99]. - Research and development expenses were $19.4 million for Q2 2024, down from $27.3 million in Q2 2023, reflecting a decrease of 28.9%[98]. Cash and Financing - The company has cash, cash equivalents, and marketable securities of $123.1 million, expected to fund operations for at least the next 12 months[81]. - Cash, cash equivalents, and investments totaled $123.1 million as of June 30, 2024, sufficient to fund operations for at least the next 12 months[112]. - Net cash used in operating activities was $49.5 million for the six months ended June 30, 2024, compared to $62.7 million for the same period in 2023, a decrease of 21%[117]. - Net cash provided by financing activities was $0.1 million for the six months ended June 30, 2024, compared to $1.5 million for the same period in 2023[122]. - The company intends to seek additional capital through private or public equity or debt financings to support product development and operations[123]. - Future equity or debt financings may impose unfavorable terms that could restrict operations and limit financial flexibility[125]. Clinical Development - The ongoing Phase 1 clinical trial of AK006 has shown a favorable safety profile, with high receptor occupancy on mast cells and an estimated half-life of 21 days for the highest IV dose of 720 mg[81]. - The company plans to report safety, pharmacokinetics (PK), and pharmacodynamics (PD) data for the subcutaneous formulation of AK006 in the third quarter of 2024[81]. - The company is testing AK006 in a randomized, double-blind, placebo-controlled cohort of patients with chronic spontaneous urticaria (CSU), with data expected by year-end 2024[80]. - The company has halted development of lirentelimab (AK002) following Phase 2 results, which were administered to over 1,000 patients[81]. - The company anticipates a decrease in expenses in the second half of 2024 compared to the first half due to reduced costs related to lirentelimab and the reorganization plan[87]. Asset Management - The company recognized a long-lived asset impairment charge of $27.3 million during the six months ended June 30, 2024[108]. - The company recorded no expenses related to the impairment of long-lived assets during Q2 2024, maintaining the same status as Q2 2023[100]. Organizational Changes - The company has implemented a 2024 Reorganization Plan, resulting in a workforce reduction of approximately 50% to align with current clinical development plans[81]. Contractual Obligations - The company has contractual obligations primarily related to operating leases and agreements with research and development organizations[126]. - Agreements with vendors for goods and services may require significant upfront payments and long-term capital commitments[127]. - The company has not entered into any off-balance sheet arrangements since inception[128]. - As a smaller reporting company, the company is not required to provide disclosures about market risk[129].

Financial Performance - Allakos reported a net loss of $26.7 million for Q2 2024, a decrease from a net loss of $35.1 million in Q2 2023, resulting in a net loss per share of $0.30 compared to $0.41 in the prior year[6]. - General and administrative expenses decreased to $9.2 million in Q2 2024 from $10.5 million in Q2 2023, primarily due to reduced compensation costs[6]. - Total operating expenses for Q2 2024 were $28.6 million, down from $37.8 million in Q2 2023[9]. Research and Development - Research and development expenses decreased to $19.4 million in Q2 2024 from $27.3 million in Q2 2023, attributed to lower contract research costs and decreased compensation[5]. - Allakos initiated a Phase 1 trial of intravenous AK006 in patients with chronic spontaneous urticaria and completed dosing in a subcutaneous cohort[2]. - The company plans to report safety, pharmacokinetics, and pharmacodynamic results from the Phase 1 trial of subcutaneous AK006 in Q3 2024[3]. Cash and Assets - Allakos ended Q2 2024 with $123.1 million in cash, cash equivalents, and investments, reflecting a net decrease of $16.2 million during the quarter[5]. - The company expects to end 2024 with total cash, cash equivalents, and investments in the range of $81 to $86 million[4]. - Allakos' total assets decreased to $156.5 million as of June 30, 2024, from $243.6 million at the end of 2023[10]. Future Costs - The company anticipates approximately $30 million in costs related to exiting the lirentelimab development program, with $13 million spent in the first half of 2024[4].

SAN CARLOS, Calif., Aug. 07, 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 second quarter ended June 30, 2024. Recent Allakos Events Initiated the randomized, double-blind, placebo-controlled Phase 1 trial of intravenous (IV) AK006 in patients with chronic spontaneous urticaria.Completed dosing in ...