Related Party Transactions

6 Months Ended

Jun. 30, 2024

Related Party Transactions [Abstract]

Related Party Transactions

11. Related Party Transactions

On April 7, 2022, the Company entered into an agreement with Biocon, who is a holder of more than 5% of the Company’s common stock, to collaborate on and co-fund a Phase 2 clinical study of itolizumab in subjects with ulcerative colitis that is being conducted by Biocon in India. The Company expects its share of the total clinical study costs will be approximately $1.5 million. During each of the three-month periods ended June 30, 2024 and 2023, the Company recognized $0.2 million and $0.1 million, respectively, of research and development expense related to its portion of the total clinical study costs. During each of the six-month periods ended June 30, 2024 and 2023, the Company recognized $0.4 million and $0.2 million, respectively, of research and development expense related to its portion of the total clinical study costs. As of June 30, 2024 and December 31, 2023, the Company had accrued expenses totaling $0.3 million and $0.4 million, respectively, and $0.3 million and no amounts invoiced, respectively, by and payable to Biocon related to the Company’s portion of the total clinical study costs.

In February 2020, the Company entered into a master services agreement with Syngene International Limited (Syngene), a wholly-owned subsidiary of Biocon, for CMC services associated with itolizumab development (the Syngene MSA). In July 2023, the Company issued a signed work order under the Syngene MSA totaling $5.4 million for CMC activities related to the development of a pre-filled syringe product presentation for itolizumab. Of the total work order value, $0.7 million is a firm commitment as of June 30, 2024. In addition, the Company is working with Biocon on several CMC projects in preparation for a potential BLA filing related to itolizumab and has entered into several purchase orders totaling approximately $6.1 million to support these CMC projects. During the three and six months ended June 30, 2024, the Company recognized research and development expenses totaling $1.1 million and $2.1 million, respectively, related to these CMC agreements. During the three and six months ended June 30, 2023, there were no material research and development expenses recognized related to these CMC agreements. As of June 30, 2024 and December 31, 2023, the Company had accrued expenses totaling $0.4 million and $0.7 million, respectively, and $1.2 million and an immaterial amount, respectively, was invoiced by and payable to Biocon and Syngene.

Aforementioned expenses associated with work performed by Biocon or its affiliates related to itolizumab development during the Ono option period are reimbursed by Ono pursuant to the terms of the Asset Purchase Agreement.

The Company classifies its accruals related to these activities as accrued expenses on the accompanying condensed consolidated balance sheets. The Company classifies amounts invoiced by and payable to Biocon and Syngene as accounts payable on the accompanying condensed consolidated balance sheets.