Financial Performance - For the three months ended March 31, 2025, the company reported a net loss of $26.2 million, compared to a net loss of $71.1 million for the same period in 2024, indicating a significant reduction in losses year-over-year[88]. - Net loss for Q1 2025 was $26.2 million, significantly improved from a net loss of $71.1 million in Q1 2024[115]. - Total operating expenses decreased to $26.7 million in Q1 2025 from $73.1 million in Q1 2024, a decrease of $46.4 million[110]. - Research and development expenses decreased to $13.5 million for Q1 2025 from $34.8 million in Q1 2024, a reduction of $21.3 million[110]. - General and administrative expenses increased to $13.2 million in Q1 2025 from $10.9 million in Q1 2024, an increase of $2.3 million[110]. - Net cash used in operating activities was $28.4 million for Q1 2025, down from $32.5 million in Q1 2024[123]. - Net cash provided by investing activities was $33.4 million in Q1 2025, compared to $9.0 million in Q1 2024[125]. - Interest income decreased to $0.7 million in Q1 2025 from $2.0 million in Q1 2024, primarily due to a lower balance of investments[113]. Financial Position - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $55.2 million, which is expected to fund operations for at least the next 12 months[91]. - The company has incurred an accumulated deficit of $1,260.5 million as of March 31, 2025, reflecting ongoing financial challenges[88]. - Cash, cash equivalents, and investments totaled $55.2 million as of March 31, 2025, sufficient to fund operations for at least the next 12 months[116]. Strategic Initiatives - The company plans to reduce its workforce by approximately 75% under the 2025 Reorganization Plan to align with strategic alternatives and reduce operating costs[89]. - The company has implemented a 2024 Reorganization Plan, which included a workforce reduction of approximately 50% and the termination of its San Carlos Lease[90]. - The company continues to explore strategic alternatives, including potential mergers, asset divestitures, and licensing opportunities to maximize stockholder value[86]. - The Merger Agreement with Concentra Biosciences is expected to close in May 2025, pending satisfaction of closing conditions, with an offer price of $0.33 per share[85]. Development Programs - The company announced the discontinuation of the AK006 development program following a Phase 1 clinical trial that did not demonstrate therapeutic activity[86]. Asset Impairment - The company recognized a long-lived asset impairment charge of $27.3 million during the three months ended March 31, 2024, due to a significant decline in stock price[103]. - No impairment charges were recognized in Q1 2025, contrasting with $27.3 million in impairment charges in Q1 2024[112]. Capital Raising - The company has filed two shelf registration statements with the SEC, allowing for the potential sale of up to $250 million in common stock[118][119].

Corporate Update February 15, 2022 Disclaimer This presentation contains forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regarding the financial position of Allakos Inc. ("Allakos," the "Company," "we" or "our"); the generation of future value; business strategy; plans and objectives for future operations; our expectations regarding the potential benefits, activity, effectiveness and safety of our product candidates; ou ...

Corporate Update January 2024 Developing Therapeutic Antibodies Targeting Allergic, Inflammatory and Proliferative Disease Disclaimer This presentation contains forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regarding the financial position of Allakos Inc. ("Allakos," the "Company," "we" or "our"); estimated lirentelimab closeout, severance and other costs; the timing of payment of restructuring expenditures; estimated ...

Group 1 - Monteverde & Associates PC has recovered millions for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report [1] - The firm is investigating Allakos Inc. regarding its proposed merger with Concentra Biosciences, which will acquire Allakos for $0.33 in cash per share [1] Group 2 - Monteverde & Associates PC is a national class action securities firm with a successful track record in trial and appellate courts, including the U.S. Supreme Court [2] - The firm operates from the Empire State Building in New York City [2]

Core Points - Allakos Inc. has entered into a definitive merger agreement with Concentra Biosciences, LLC, where Concentra will acquire Allakos for $0.33 in cash per share of Allakos common stock [1][2] - The Board of Directors of Allakos has unanimously approved the merger agreement, determining it to be in the best interests of all shareholders [2] - A wholly owned subsidiary of Concentra is expected to commence a tender offer by April 15, 2025, to acquire all outstanding shares of Allakos common stock [2][3] - The closing of the merger is subject to conditions, including the tender of a majority of Allakos common stock and the availability of at least $35.5 million in cash at closing [3] - Approximately 8.07% of Allakos common stock is held by officers, directors, and affiliates who have signed support agreements to tender their shares in the offer [3] - The merger transaction is anticipated to close in May 2025 [3] Company Overview - Allakos is a biotechnology company focused on developing therapeutics targeting immunomodulatory receptors involved in allergic, inflammatory, and proliferative diseases [4]

Financial Performance - The company has incurred net losses of $115.8 million and $185.7 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $1,234.3 million as of December 31, 2024[138]. - The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future[140]. - The company has not generated any revenue to date and does not anticipate generating revenue from product sales until after successfully completing clinical development and receiving marketing approval[141]. - As of December 31, 2024, the company had $80.8 million in cash, cash equivalents, and marketable securities[145]. - The company received aggregate net proceeds of $140.6 million from a public offering of 29,882,000 shares at a price of $5.02 per share[145]. - The company may require substantial additional capital to finance operations and pursue business strategies, which could delay or eliminate drug development programs[144]. - The company has only received $1.0 million in net proceeds under its "at-the-market" program, indicating limited capital raising success[145]. - The company has gross U.S. federal net operating loss carryforwards of $967.0 million and state net operating loss carryforwards of $987.3 million as of December 31, 2024[301]. - Federal net operating loss carryforwards of $905.2 million generated after December 31, 2017, do not expire, while $61.8 million will begin to expire in 2032[301]. - The company has never declared or paid any cash dividends on its common stock and does not anticipate doing so in the foreseeable future, limiting returns to stockholders to stock value appreciation[275]. Strategic Direction - The company has discontinued the development of AK006 and is focusing on exploring strategic alternatives, which may extend into the second quarter of 2025[130]. - A corporate restructuring plan has been implemented to reduce the workforce by approximately 75%[133]. - The company has reduced its workforce by approximately 50% under the 2024 Reorganization Plan due to clinical trial results[136]. - The process of reviewing strategic alternatives may be time-consuming and disruptive to business operations, potentially affecting financial condition and results[130]. - The company plans to use existing cash for research and development activities, working capital, and exploring strategic alternatives[146]. - The company may need to reevaluate its operating plan if unable to raise capital when needed, impacting its ability to pursue business strategies[144]. Clinical Development and Regulatory Risks - The Phase 1 clinical trial of AK006 in patients with CSU failed to meet its primary endpoints, leading to the decision to discontinue its development[141]. - The company has no product candidates approved for sale and faces high risks of clinical trial failures[161]. - The company must demonstrate substantial evidence of safety and efficacy through well-controlled clinical trials before seeking marketing approvals[161]. - Clinical trial results may exhibit significant variability due to factors such as trial protocols and patient population differences, leading to potential negative or inconclusive outcomes[163]. - The company faces risks related to the number of patients required for clinical trials being larger than anticipated, slower enrollment, and higher dropout rates[30]. - The company faces challenges in patient enrollment for clinical trials, which could delay marketing approvals[153]. - Regulatory approval processes are lengthy and unpredictable, with no assurance that any product candidates will receive approval[179]. - The time required to obtain FDA and other regulatory approvals is unpredictable and typically takes many years, depending on the complexity of the product[183]. - Any delay or failure in obtaining required approvals could materially affect the company's ability to generate revenue from its product candidates[184]. - The company may face significant regulatory hurdles that could delay or prevent the commercialization of its product candidates[182]. - Clinical trials may reveal adverse events or side effects that could inhibit regulatory approval or market acceptance of the product candidates[187]. - If significant adverse events are observed, the company may face difficulties in recruiting patients for clinical trials, which could lead to trial abandonment[188]. - Regulatory approvals will require ongoing compliance with extensive post-marketing requirements, including safety monitoring and potential restrictions on use[193]. Competition and Market Challenges - The company may face significant competition from established pharmaceutical and biotechnology companies with greater resources and experience[176]. - The success of product candidates is highly dependent on achieving regulatory approval and market acceptance among healthcare providers and payors[165]. - The company may encounter challenges with third-party reimbursement practices, which are essential for commercial success[170]. - The estimated patient populations for targeted diseases may be inaccurate, potentially limiting the addressable market for future product candidates[167]. - The company faces significant competition for qualified personnel, particularly in the biotechnology field, which may hinder its ability to attract and retain skilled employees[217]. - The company is currently not in compliance with Nasdaq's minimum bid price requirement of $1.00 per share, with a 180-day grace period to regain compliance[149]. Intellectual Property and Legal Risks - The company has filed numerous patent applications in the U.S. and foreign jurisdictions, but the patent prosecution process is expensive and time-consuming[222]. - The company may not be able to protect its intellectual property rights effectively in foreign jurisdictions, which could allow competitors to develop similar products[230]. - The company anticipates that its owned patent family for a product candidate will expire in 2035 in the U.S., potentially exposing it to competition from generics[227]. - The company does not own registered trademarks for "ALLAKOS," which may hinder brand recognition and expose the company to potential trademark disputes[237]. - Legal proceedings initiated by third parties alleging infringement could lead to significant litigation costs and distract management from core business activities[241]. - The company may need to relinquish valuable rights to technologies or future revenue streams if it raises additional funds through partnerships or licensing arrangements[272]. Operational and Compliance Risks - The company relies on third parties for clinical trials, which may not perform satisfactorily, potentially delaying drug development and marketing approvals[248]. - Non-compliance with Good Clinical Practice (GCP) regulations could result in unreliable clinical data, requiring additional trials and delaying marketing approval[249]. - The reliance on third-party manufacturers for product candidates increases the risk of supply disruptions, which could delay or impair development and commercialization efforts[252]. - The company expects to continue relying on third-party manufacturers for the commercial supply of product candidates, which entails risks related to compliance with cGMP regulations and quality control[253]. - The potential failure of third-party manufacturers to meet specifications or schedules could significantly impact the company's ability to develop and market its product candidates[253]. - The company is subject to numerous environmental, health, and safety laws, and failure to comply could result in significant fines or penalties[283]. - The company has policies to comply with anti-bribery and anti-corruption laws, but there is no assurance that all employees and partners will adhere to these policies[288]. Economic and Market Conditions - The company is exposed to market risk related to changes in interest rates, with a hypothetical 10% change in interest rates not materially affecting the fair market value of cash equivalents and marketable securities[381]. - Inflation has not had a material effect on the company's financial results during the periods presented[382]. - The company is subject to foreign exchange risk due to certain service agreements denominated in currencies other than the U.S. Dollar, primarily the British Pound and Euro[383]. - Changes in tax laws, such as the Tax Cuts and Jobs Act of 2017 and the Inflation Reduction Act, may negatively impact the company's financial condition and results of operations[302]. Governance and Management - As of December 31, 2024, executive officers, directors, and holders of 5% or more of the capital stock beneficially owned approximately 38.3% of the outstanding voting stock, allowing them to exert significant control over stockholder approval matters[273]. - The company is highly dependent on its Chief Executive Officer and President, and the loss of key executives could adversely affect its business operations[217]. - The company's disclosure controls and procedures may not prevent all errors or acts of fraud, leading to potential misstatements[297].

Financial Position - As of December 31, 2024, Allakos Inc. reported an estimated unaudited cash, cash equivalents, and investments balance[6]. Discontinuation of AK006 - The company plans to discontinue the development of AK006, resulting in a workforce reduction of approximately 75%[10]. - Estimated costs related to discontinuing AK006 activities and workforce reduction are approximately $34 million to $38 million, with $24 million to $28 million for AK006 activities and $10 million for workforce reduction[8]. - The Phase 1 clinical trial of AK006 in patients with chronic spontaneous urticaria did not demonstrate therapeutic activity[10]. Restructuring Efforts - The majority of the estimated restructuring costs are expected to be paid in the first half of 2025[8]. - The company is exploring strategic alternatives following the discontinuation of AK006[10]. - The restructuring activities are subject to risks and uncertainties that could affect the anticipated benefits[12]. - The company aims to maintain its listing on Nasdaq amid restructuring efforts[12]. - Allakos Inc. has not provided specific future revenue guidance following the restructuring announcement[12]. - The company may incur additional costs related to the corporate restructuring that are not currently anticipated[8].

Core Insights - Allakos Inc. provided a business update and reported financial results for Q4 2024, highlighting a significant restructuring and cost reduction strategy following the discontinuation of AK006 development [1][10]. Financial Overview - The company ended Q4 2024 with $80.8 million in cash, cash equivalents, and investments, reflecting a net decrease of $11.9 million during the quarter [2][4]. - Research and development expenses decreased to $14.8 million in Q4 2024 from $53.8 million in Q4 2023, a reduction of $39.0 million, primarily due to halting lirentelimab development [5]. - General and administrative expenses were $9.8 million in Q4 2024, down from $11.2 million in Q4 2023, a decrease of $1.4 million [6]. - Allakos reported a net income of $0.4 million in Q4 2024, a significant improvement compared to a net loss of $62.6 million in Q4 2023, mainly due to a $23.9 million gain on a lease amendment [7]. Restructuring and Cash Guidance - The company estimates restructuring costs related to closing out AK006 development will be approximately $34 million to $38 million, with most costs expected to be paid in the first and second quarters of 2025 [3]. - Allakos anticipates having cash, cash equivalents, and investments in the range of $35 million to $40 million by June 30, 2025 [3]. Company Background - Allakos is a clinical-stage biotechnology company focused on developing therapeutics targeting immunomodulatory receptors involved in allergic, inflammatory, and proliferative diseases [8].

Core Insights - Allakos Inc has decided to discontinue the clinical development of AK006 for chronic spontaneous urticaria (CSU) after the phase 1 trial did not show clinical benefits despite preclinical inhibitory effects [1][2] Group 1: Clinical Trial Results - The phase 1 clinical trial involved 34 adult patients with CSU, randomized to receive either 720 mg of intravenous AK006 or placebo [2] - AK006 was well-tolerated with no serious adverse events reported among subjects receiving the treatment [2] - Previous results from a phase 1 study of subcutaneous AK006 in healthy volunteers indicated approximately 77% bioavailability and prolonged receptor occupancy on mast cells [4] Group 2: Company Actions - The company plans to discontinue all AK006-related activities across clinical, manufacturing, research, and administrative functions, leading to a workforce reduction of approximately 75% [3] - Allakos will retain around 15 employees to explore strategic alternatives and maintain compliance with regulatory and financial reporting requirements [3] Group 3: Financial Implications - As of the end of Q4 2024, Allakos reported approximately $81 million in cash, cash equivalents, and investments [5] - The company estimates restructuring costs related to closing out AK006 development will be between $34 million and $38 million, primarily incurred in the first and second quarters of 2025 [5] - By June 30, 2025, Allakos expects to have approximately $35 million to $40 million in cash, cash equivalents, and investments [6] Group 4: Market Reaction - Following the announcement, ALLK stock experienced a significant decline of 78.5%, trading at $0.26 [6]

Core Insights - Allakos Inc. has announced the discontinuation of further development of AK006 after it did not demonstrate therapeutic activity in chronic spontaneous urticaria (CSU) [1][2] - The company will reduce its workforce by approximately 75% and explore strategic alternatives [1][8] Clinical Trial Results - In a phase 1 clinical trial, 34 adult patients with moderate-to-severe CSU were enrolled, with 23 receiving AK006 and 11 receiving placebo [2] - The baseline Urticaria Activity Score (UAS7) for AK006 was 34.4 compared to 30.5 for placebo, with a mean change in UAS7 of -8.2 for AK006 and -12.4 for placebo [3] - The complete response rate (UAS7=0) was 9% for both AK006 and placebo groups [3] Safety Profile - AK006 was well-tolerated with no serious adverse events reported; common mild-to-moderate adverse events included headache and infusion-related reactions [4] Financial and Restructuring Actions - The company ended Q4 2024 with approximately $81 million in cash and investments [5] - Estimated restructuring costs to close out AK006 development are between $34 million to $38 million, primarily to be paid in the first and second quarters of 2025 [6] - The company anticipates having cash and equivalents in the range of $35 million to $40 million by June 30, 2025 [6] Workforce Reduction - Allakos plans to retain approximately 15 employees to explore strategic alternatives and maintain compliance with regulatory requirements [8]