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Commitments and Contingencies
12 Months Ended
Dec. 31, 2021
Commitments And Contingencies Disclosure [Abstract]  
Commitments and Contingencies

7.

Commitments and Contingencies

Manufacturing Agreements

 

On May 20, 2016, the Company signed a development and manufacturing services agreement with AGC Biologics, Inc. (“AGC”), pursuant to which AGC will conduct manufacturing development of agreed upon product candidates. The Company had firm work orders with AGC to manufacture MarzAA and DalcA to support its clinical trials totaling $15.8 million and the payment obligations were fully paid off as of December 31, 2021. The Company also signed an agreement with AGC to perform certain manufacturing services related to the Company’s collaboration agreement with Biogen, which includes firm work orders totaling $0.7 million and the payment obligations remaining as of December 31, 2021 were $0.3 million.

 

In July 2021, the Company entered into two separate agreements, one for additional clinical trial services for MarzAA, and another for the Company’s screening and natural history of disease clinical studies related to CFI deficiency, with total payments of up to $3.2 million and $6.5 million, respectively. In November 2021, the Company provided notice of intent to terminate its MarzAA manufacturing agreements and incurred charges of $3.8 million to write-off prepaid manufacturing costs that will no longer be used for the clinical development of MarzAA, see Note 16, Restructuring. The Company can terminate the CFI agreement at its discretion and upon termination will be responsible to pay for those services incurred prior to termination plus reasonable wind-down expenses.

 

On September 16, 2021, the Company signed a Manufacturing and Research and Development Studies Agreement to support the lyophilized drug product, CB4332. The agreement will cover analytical method qualification to support good manufacturing practices (“GMP”) manufacturing. The Company currently has firm work orders related to this agreement totaling $0.2 million and the payment obligations were fully paid off as of December 31, 2021.

COVID-19

The current COVID-19 pandemic has presented a substantial public health and economic challenge around the world and is affecting the Company’s employees, potential trial participants and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national, and international markets. The COVID-19 pandemic may disrupt the operations of the Company’s manufacturers or disrupt supply logistics, which could impact the timing of deliveries and potentially increase expenses under our agreements.

The Company is actively monitoring the impact of COVID-19 and the possible effects on its financial condition, liquidity, operations, clinical trials, suppliers, industry and workforce.