AK-006

– AK006 did not demonstrate therapeutic activity in CSU –– Allakos will discontinue further development of AK006, reduce workforce by 75% and explore strategic alternatives –– Management to host conference call and webcast today at 8:30 am E.T. – SAN CARLOS, Calif., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Allakos Inc. (Company) (Nasdaq: ALLK), today announced topline results from its phase 1 clinical trial of AK006 in chronic spontaneous urticaria (CSU). “While AK006 was well tolerated, we are disappointed that the preclinical inhibitory effects observed did not translate to clinical benefit in patients with CSU. As a result, the Company has decided to discontinue further clinical development of AK006,” said Chin Lee, M.D, M.P.H., Chief Medical Officer of Allakos. “We express our gratitude to all of the patients, clinical trial investigators, and site coordinators in these trials.” Phase 1 Cohort of AK006 in Patients with Chronic Spontaneous Urticaria In the CSU cohort, 34 adult patients with moderate-to-severe CSU refractory to antihistamines with or without prior exposure to omalizumab were enrolled and randomized 2:1 to receive 720 mg of intravenous AK006 (n=23) or placebo (n=11) once every four weeks (Q4W). Eight of the 34 patients had previously received omalizumab (5 randomized to AK006, 3 randomized to placebo). The primary endpoint of the proof-of-concept cohort was safety and tolerability with therapeutic activity explored using the Urticaria Activity Score (UAS)-7 at 14 weeks. Exploratory Efficacy Results AK006 (n=23)Placebo (n=11)Baseline Urticaria Activity Score (UAS7)34.430.5Mean Change in UAS7-8.2-12.4% UAS7=0: Complete Response9% (2/23)9% (1/11) Safety ResultsAK006 was well-tolerated with a favorable safety profile. There were no serious adverse events (SAEs) in subjects on AK006. Adverse events occurring in 2 or more subjects on AK006 were headache (2), infusion related reaction (2), and Covid-19 (2) vs. 1, 0, and 0, respectively, on placebo, all of which were mild-to-moderate in severity. Restructuring Activities & Planned Actions The Company plans to discontinue AK006-related activities across clinical, manufacturing, research and administrative functions and reduce its workforce by approximately 75%.The Company plans to retain approximately 15 employees to explore strategic alternatives, maintain compliance with regulatory and financial reporting requirements, and wind-down the phase 1 clinical trial. Cash GuidanceThe Company ended the fourth quarter of 2024 with approximately $81 million in cash, cash equivalents, and investments (unaudited). The Company estimates that cash used in restructuring activities to closeout AK006 development, including severance and contractual payments to vendors, will be approximately $34 million to $38 million. The Company also estimates that a significant majority of these restructuring costs will be paid over the first and second quarters of 2025. The Company estimates it will have cash, cash equivalents and investments in a range of approximately $35 million to $40 million at June 30, 2025. Conference Call and Webcast Information The webcast and conference call will take place at 8:30 am ET / 5:30 am PT on January 27th, 2025. 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 here. 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. About Allakos Allakos is a clinical stage biotechnology company that has been developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Forward-Looking Statements 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’ expectations regarding its financial position and guidance, including estimated costs of restructuring activities to closeout AK006 development, the timing of payment of such restructuring costs, and estimated ending 2024 and second quarter 2025 cash, cash equivalents and investments; restructuring activities and plans; and exploration of strategic alternatives. Such statements are based on Allakos’ current views about its plans, intentions, expectations, strategies and prospects only as of the date of this release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from those set forth in or implied by such forward-looking statements, including but not limited to: uncertainties related to Allakos’ ability to realize the contemplated benefits of its restructuring activities and related reduction in force; Allakos’ ability to accurately forecast financial results, including restructuring and other costs and expenses; availability of suitable third parties with which to conduct contemplated strategic alternative transactions; whether Allakos will be able to pursue strategic alternative transactions, or whether any transaction, if pursued, will be completed on attractive terms; whether Allakos’ cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; Allakos’ ability to maintain the listing of its common stock on Nasdaq; general economic and market conditions, both domestic and international; risks associated with volatility and uncertainty in the capital markets for biotechnology companies; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Allakos files from time to time to with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos’ forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos’ views as of any date subsequent to the date of this press release. Source: Allakos Inc. Investor Contact:Adam Tomasi, PresidentAlex Schwartz, VP Strategic Finance and Investor Relationsir@allakos.com Media Contact:media@allakos.com

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 of subcutaneous AK006 was approximately 77%.Subcutaneous administered AK006 showed an estimated half-life of 12-22 days.Consistent with the IV formulation, skin biopsies taken from subcutaneous AK006 treated healthy volunteers showed high levels of receptor occupancy confirming AK006 reaches skin tissue mast cells.The 720 mg dose of AK006 showed 98% receptor occupancy at day 113 suggesting the potential for infrequent dosing.Single and multiple doses of IV AK006 and single dose subcutaneous AK006 up to 720 mg were well tolerated with a favorable safety profile. Completed enrollment of over 30 patients in the randomized, double-blind, placebo-controlled Phase 1 trial of intravenous (IV) AK006 in patients with chronic spontaneous urticaria. Data from these patients expected in early Q1 of 2025. Upcoming Allakos Anticipated Milestones Report randomized double-blind, placebo-controlled data on over 30 patients from the Phase 1 trial of AK006 in patients with CSU in early Q1 of 2025. Cash Guidance Allakos ended the third quarter of 2024 with $92.7 million in cash, cash equivalents and investments. Allakos’ financial outlook, restructuring activities and estimated cash runway as reported by the Company in January 2024 remain unchanged. The Company reiterates that it expects the restructuring activities will extend the cash runway into mid-2026 and to end 2024 with total cash, cash equivalents and investments in its previously stated $81 to $86 million guidance range. The Company has substantially completed its exit of the lirentelimab development program. Third Quarter 2024 Financial Results Allakos ended the third quarter of 2024 with $92.7 million in cash, cash equivalents and investments resulting in a net decrease in cash, cash equivalents and investments of $30.4 million during the third quarter of 2024. Approximately $18 million of this third quarter decrease was paid in connection with exiting the lirentelimab development program. Research and development expenses were $10.9 million in the third quarter of 2024 compared to $36.7 million in the third quarter of 2023, a decrease of $25.8 million. This quarter over quarter decrease is attributed to $16.4 million of lower contract research and development costs, primarily due to halting lirentelimab development and includes a $4.6 million decrease relating to a change in estimated manufacturing costs upon resolution of the related work orders with the vendor, $5.7 million of decreased compensation costs and a $3.7 million decrease in other research and development expenses. General and administrative expenses were $8.9 million for the third quarter of 2024 compared to $11.5 million for the third quarter of 2023, a decrease of $2.6 million. The quarter over quarter change included $2.4 million of decreased compensation costs and $0.2 million of decreased other general and administrative expenses. Allakos reported a net loss of $18.4 million in the third quarter of 2024 compared to $45.6 million in the third quarter of 2023. Net loss per basic and diluted share was $0.21 for the third quarter of 2024 compared to $0.52 in the third quarter of 2023. About Allakos Allakos is a clinical stage biotechnology company developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells. The Company’s most advanced product candidate is AK006. AK006 targets Siglec-6, an inhibitory receptor expressed on mast cells. Mast cells are widely distributed in the body and play a central role in the inflammatory response. Inappropriately activated mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. In preclinical studies, AK006 appears to provide deep mast cell inhibition and, in addition to its inhibitory activity, reduce mast cell numbers. For more information, please visit the Company’s website at www.allakos.com. Forward-Looking Statements 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’ expected timing of reporting data from its clinical trial of AK006; cash guidance and runway; and restructuring. 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 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 Allakos is targeting; Allakos’ ability to advance additional product candidates beyond AK006; uncertainties related to Allakos’ ability to realize the contemplated benefits of its restructuring and related reduction in force; Allakos’ ability to accurately forecast financial results; Allakos’ ability to obtain additional capital to finance its operations, research and drug development; Allakos’ ability to maintain the listing of our common stock on Nasdaq; general economic and market conditions, both domestic and international; domestic and international regulatory obligations; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Allakos files from time to time to with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos’ forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos’ views as of any date subsequent to the date of this press release. Source: Allakos Inc. Investor Contact:Adam Tomasi, PresidentAlex Schwartz, VP Strategic Finance and Investor Relationsir@allakos.com Media Contact:media@allakos.com ALLAKOS INC.UNAUDITED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except per share data) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Operating expenses Research and development $10,874 $36,749 $65,120 $97,107 General and administrative 8,876 11,461 28,985 33,966 Impairment of long-lived assets — — 27,347 — Total operating expenses 19,750 48,210 121,452 131,073 Loss from operations (19,750) (48,210) (121,452) (131,073)Interest income 1,392 2,590 5,346 7,965 Other expense, net (14) (6) (88) (42)Net loss (18,372) (45,626) (116,194) (123,150)Unrealized gain (loss) on investments 325 87 284 212 Comprehensive loss $(18,047) $(45,539) $(115,910) $(122,938)Net loss per common share: Basic and diluted $(0.21) $(0.52) $(1.31) $(1.42)Weighted-average number of commonshares outstanding: Basic and diluted 89,024 87,115 88,571 86,539 ALLAKOS INC.UNAUDITED CONDENSED BALANCE SHEETS(in thousands) September 30, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $10,449 $66,440 Investments 82,266 104,354 Prepaid expenses and other current assets 4,438 9,095 Total current assets 97,153 179,889 Property and equipment, net 15,733 33,369 Operating lease right-of-use assets 9,880 24,136 Other long-term assets 1,668 6,216 Total assets $124,434 $243,610 Liabilities and stockholders’ equity Current liabilities: Accounts payable $3,964 $1,764 Accrued expenses and other current liabilities 12,017 34,814 Total current liabilities 15,981 36,578 Operating lease liabilities, net of current portion 35,710 38,215 Total liabilities 51,691 74,793 Stockholders’ equity: Common stock 89 88 Additional paid-in capital 1,306,991 1,287,156 Accumulated other comprehensive gain (loss) 334 50 Accumulated deficit (1,234,671) (1,118,477) Total stockholders’ equity 72,743 168,817 Total liabilities and stockholders’ equity $124,434 $243,610