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Allakos to be acquired by Concentra Biosciences for 33c per share in cash
Allakos has entered into a definitive merger agreement whereby Concentra Biosciences will acquire Allakos for $0.33 in cash per share of Allakos common stock. Allakos' Board of Directors has unanimously determined that the acquisition by Concentra is in the best interests of all Allakos shareholders and, following the unanimous recommendation of Allakos' Transaction Committee, has approved the Merger Agreement and related transactions. Pursuant and subject to the terms of the Merger Agreement, a wholly owned subsidiary of Concentra will commence a tender offerby April 15, 2025 to acquire all outstanding shares of Allakos Common Stock. Closing of the Offer is subject to certain conditions, including the tender of Allakos Common Stock representing at least a majority of the total number of outstanding shares, the availability of at least $35.5M of cash at closing, and other customary closing conditions. Allakos officers, directors and their respective affiliates holding approximately 8.07% of Allakos Common Stock have signed support agreements under which such parties have agreed to tender their shares in the Offer and support the merger transaction. The merger transaction is expected to close in May 2025.
Allakos reports Q4 EPS 0c, consensus (18c)
Allakos ended the fourth quarter of 2024 with $80.8M in cash, cash equivalents and investments.
Allakos to discontinue further clinical development of AK006, cut workforce 75%
Shares of Allakos are down 75% in pre-market trading after the company announced it will discontinue further clinical development of AK006 after the preclinical inhibitory effects observed did not translate to clinical benefit in patients with CSU. 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 or placebo once every four weeks . Eight of the 34 patients had previously received omalizumab. The primary endpoint of the proof-of-concept cohort was safety and tolerability with therapeutic activity explored using the Urticaria Activity Score-7 at 14 weeks. 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. The company ended the fourth quarter of 2024 with approximately $81M in cash, cash equivalents, and investments. The company estimates that cash used in restructuring activities to closeout AK006 development, including severance and contractual payments to vendors, will be approximately $34M-$38M. 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 $35M-$40M at June 30, 2025.
Allakos announces results from its Phase 1 trial of AK006
Allakos announced topline results from its phase 1 clinical trial of AK006 in 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 or placebo once every four weeks. Eight of the 34 patients had previously received omalizumab. The primary endpoint of the proof-of-concept cohort was safety and tolerability with therapeutic activity explored using the Urticaria Activity Score-7 at 14 weeks. AK006 was well-tolerated with a favorable safety profile. There were no serious adverse events in subjects on AK006. Adverse events occurring in 2 or more subjects on AK006 were headache, infusion related reaction, and Covid-19 vs. 1, 0, and 0, respectively, on placebo, all of which were mild-to-moderate in severity.
Allakos announces results from AK006 study
Allakos announced results from the Phase 1 study of subcutaneous AK006 in healthy volunteers. AK006 is a Siglec-6 monoclonal antibody that selectively inhibits mast cells. Inappropriate activation of mast cells has been identified as a pathogenic driver of multiple diseases, including chronic spontaneous urticaria, food allergy and asthma. 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. In the safety profile to date: There were no serious adverse events, or SAEs, in subjects on AK006. There were no treatment emergent adverse events leading to discontinuation of AK006. There were no dose limiting toxicities. The most common adverse events occurring more frequently in subjects on AK006 were headache and dysmenorrhea, all of which were mild-to-moderate in severity.
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