Antolimab

Investors sent Celldex’s share price down by 18% to $19.72 in premarket trading.\n Celldex has stopped development of barzolvolimab in eosinophilic esophagitis (EoE) despite meeting its primary endpoint in a phase 2 trial. The biotech showed the candidate depletes mast cells in the gastrointestinal tract, but that positive finding was overshadowed by the antibody\'s failure to improve clinical outcomes.EoE is a chronic inflammatory condition of the esophagus characterized by the infiltration of eosinophils and mast cells, two types of white blood cells. Yet, efforts to treat the condition by targeting white blood cells have floundered. Allakos’ lirentelimab reduced eosinophils in a phase 2/3 trial but showed no significant effect on a dysphagia scale that assessed patients’ ability to swallow food, a key symptom of EoE.Now, Celldex has suffered a similar setback. The biotech randomized 65 patients to receive the anti-KIT antibody barzolvolimab or placebo. After 12 weeks, mucosal mast cell levels in the gastrointestinal tract had fallen significantly in the barzolvolimab cohort compared to placebo, achieving the trial’s primary endpoint. Previously, Celldex had shown the antibody can deplete cutaneous mast cells.Yet, the mucosal mast cell primary endpoint was just one of two key areas of focus for Celldex. The biotech also wanted to show that depleting mast cells improves symptoms, as Celldex CEO Anthony Marucci explained on a Tuesday call with investors to discuss the data.“We have repeatedly said that we needed to not only see profound impact of cell depletion, but we also [needed] a reduction of dysphagia scores that would be clinically meaningful and compare favorably to the current standard of care,” Marucci said. “These results did not meet our internal hurdle rate, and we will not advance development in this indication.” Scores on the Dysphagia Symptom Questionnaire were no better for patients on barzolvolimab than placebo, the biotech reported. Equally, Celldex saw no significant improvement in endoscopic scoring of EoE-related inflammation and fibrosis in the treatment group. After Celldex reported the trial findings and program discontinuation, investors sent the biotech’s share price down by 18% to $19.72 in premarket trading.Celldex is continuing to test barzolvolimab in two phase 3 trials in chronic spontaneous urticaria as well as in phase 2 studies in atopic dermatitis and prurigo nodularis. The biotech advanced in those settings on the strength of evidence that barzolvolimab depletes cutaneous mast cells. The discovery in the EoE trial that barzolvolimab also depletes mucosal mast cells could open up other indications for KIT inhibitors.  The EoE trial suggests Celldex could expand beyond skin conditions to target gastrointestinal conditions where mast cells play a role. One possibility is that Celldex will apply its bispecific approach, rather than barzolvolimab, to gastrointestinal indications. Engaging two targets may unlock diseases where depleting mast cells is beneficial but insufficient to significantly improve clinical outcomes.  The failures of Allakos and Celldex in EoE have thinned the field of late-stage programs in this indication. Amgen and AstraZeneca are still in the running, with a phase 3 trial of the partners’ anti-TSLP antibody Tezspire now fully enrolled. Tezspire reduces blood eosinophil counts but works in severe asthma patients irrespective of their starting levels of the white blood cells. 

SAN CARLOS, Calif., March 12, 2025 (GLOBE NEWSWIRE) -- Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company that has been developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, today provided a business update and reported financial results for the fourth quarter ended December 31, 2024. Recent Allakos Events Reported topline data from the Phase 1 study of AK006 in patients with chronic spontaneous urticaria in January 2025.Announced in January 2025 that the Company was discontinuing further development of AK006, restructuring operations to reduce costs and exploring strategic alternatives. Cash Guidance Allakos ended the fourth quarter of 2024 with $80.8 million in cash, cash equivalents and investments. Allakos’ financial outlook, restructuring activities and estimated cash outlook as reported by the Company in January 2025 remain unchanged. The Company estimates that cash used in restructuring activities to close out 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. Fourth Quarter 2024 Financial Results Allakos ended the fourth quarter of 2024 with $80.8 million in cash, cash equivalents and investments resulting in a net decrease in cash, cash equivalents and investments of $11.9 million during the fourth quarter of 2024. Research and development expenses were $14.8 million in the fourth quarter of 2024 compared to $53.8 million in the fourth quarter of 2023, a decrease of $39.0 million. This quarter over quarter decrease is due to halting lirentelimab development and includes a $31.2 million decrease in contract research and manufacturing costs, $6.7 million of decreased compensation costs and a $1.1 million decrease in other research and development expenses. General and administrative expenses were $9.8 million for the fourth quarter of 2024 compared to $11.2 million for the fourth quarter of 2023, a decrease of $1.4 million. The quarter over quarter change included $2.9 million of decreased compensation costs offset by a $1.5 million increase primarily from professional and other general costs associated with the termination of our office lease. Allakos reported net income of $0.4 million in the fourth quarter of 2024 compared to a net loss of $62.6 million in the fourth quarter of 2023. The gain in the fourth quarter of 2024 was primarily attributed to the $23.9 million gain on lease amendment recognized as a result of the lease termination agreement entered into during the fourth quarter of 2024. 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 close out AK006 development, the timing of payment of such restructuring costs, and estimated ending 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 ALLAKOS INC. UNAUDITED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME AND LOSS (in thousands, except per share data) Three Months Ended Twelve Months Ended December 31, December 31, 2024 2023 2024 2023 Operating expenses Research and development $14,819 $53,801 $79,939 $150,908 General and administrative 9,837 11,182 38,822 45,148 Impairment of long-lived assets — — 27,347 — Gain on lease amendment (23,883) — (23,883) — Total operating expenses 773 64,983 122,225 196,056 Loss from operations (773) (64,983) (122,225) (196,056)Interest income 1,104 2,382 6,450 10,347 Other expense, net 45 50 (43) 8 Net income (loss) 376 (62,551) (115,818) (185,701)Unrealized gain (loss) on investments (198) 122 86 334 Comprehensive income (loss) $178 $(62,429) $(115,732) $(185,367)Net income (loss) per common share: Basic and diluted $0.00 $(0.71) $(1.30) $(2.14)Weighted-average number of common shares outstanding: Basic 89,445 87,567 88,791 86,798 Diluted 90,400 87,567 88,791 86,798 ALLAKOS INC. UNAUDITED CONDENSED BALANCE SHEETS (in thousands) December 31, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $17,753 $66,440 Investments 63,067 104,354 Prepaid expenses and other current assets 4,766 9,095 Total current assets 85,586 179,889 Property and equipment, net 10,827 33,369 Operating lease right-of-use assets — 24,136 Other long-term assets 188 6,216 Total assets $96,601 $243,610 Liabilities and stockholders’ equity Current liabilities: Accounts payable $5,490 $1,764 Accrued expenses and other current liabilities 12,294 34,814 Total current liabilities 17,784 36,578 Operating lease liabilities, net of current portion — 38,215 Total liabilities 17,784 74,793 Stockholders’ equity: Common stock 90 88 Additional paid-in capital 1,312,886 1,287,156 Accumulated other comprehensive gain (loss) 136 50 Accumulated deficit (1,234,295) (1,118,477)Total stockholders’ equity 78,817 168,817 Total liabilities and stockholders’ equity $96,601 $243,610