Aligos Therapeutics, Inc. - 10-K filing on 2022-03-10

Subsequent events	12 Months Ended
Dec. 31, 2021
Subsequent Events [Abstract]
Subsequent events	16. Subsequent events Discontinued Development of STOPSTM drug candidate On January 6, 2022, the Company announced that it had halted further development of its STOPSTM drug candidate, ALG-010133, in development to address chronic hepatitis B (CHB). This decision was based on emerging data from the Phase 1 Study ALG-010133-101, that indicated that at the projected efficacious dose (400 mg, estimated to achieve liver exposures >3 x EC90 for HBsAg inhibition) there was no meaningful HBsAg reduction. Furthermore, higher dosage levels (maximum feasible dose is 600 mg) that were planned to be evaluated in a subsequent cohort are very unlikely to reach the 1 log10 IU/mL HBsAg reduction level that the Company had previously defined as necessary to advance the program. No dose limiting safety findings have been identified in CHB subjects dosed at any dose level. In early January, based on this information, the Company's management reviewed the data with members of the study’s Study Review Committee, and jointly concluded that the data was not sufficient to support further development of ALG-010133. The halt of ALG-010133 will result in a charge of approximately $1.9 million related to non-cancelable purchase obligations to be recognized in the first quarter of 2022. Merck Collaboration Agreement In January 2022, the Company and Merck & Co. entered into a First Amendment to the Exclusive License and Research Collaboration Agreement. The agreement was expanded to include the in-license by Merck of an early-stage program with respect to a second undisclosed NASH target, on which the Company had previously been working independently on. In addition, under this expanded arrangement, Merck has the ability to add an additional third target of interest in the cardiometabolic/fibrosis space to the collaboration. Under the expanded agreement, the Company will receive a payment from Merck for the in-license of the program directed at a second undisclosed NASH target. Moreover, the Company will receive an additional payment if a third target is designated for the collaboration. With respect to each target in the collaboration, the Company will be eligible to receive up to approximately $460.0 million in development and commercialization milestones as well as tiered royalties on net sales.

Subsequent events

12 Months Ended

Dec. 31, 2021

16. Subsequent events

Discontinued Development of STOPSTM drug candidate

On January 6, 2022, the Company announced that it had halted further development of its STOPSTM drug candidate, ALG-010133, in development to address chronic hepatitis B (CHB). This decision was based on emerging data from the Phase 1 Study ALG-010133-101, that indicated that at the projected efficacious dose (400 mg, estimated to achieve liver exposures >3 x EC90 for HBsAg inhibition) there was no meaningful HBsAg reduction. Furthermore, higher dosage levels (maximum feasible dose is 600 mg) that were planned to be evaluated in a subsequent cohort are very unlikely to reach the 1 log10 IU/mL HBsAg reduction level that the Company had previously defined as necessary to advance the program. No dose limiting safety findings have been identified in CHB subjects dosed at any dose level. In early January, based on this information, the Company's management reviewed the data with members of the study’s Study Review Committee, and jointly concluded that the data was not sufficient to support further development of ALG-010133. The halt of ALG-010133 will result in a charge of approximately $1.9 million related to non-cancelable purchase obligations to be recognized in the first quarter of 2022.

Merck Collaboration Agreement

In January 2022, the Company and Merck & Co. entered into a First Amendment to the Exclusive License and Research Collaboration Agreement. The agreement was expanded to include the in-license by Merck of an early-stage program with respect to a second undisclosed NASH target, on which the Company had previously been working independently on. In addition, under this expanded arrangement, Merck has the ability to add an additional

third target of interest in the cardiometabolic/fibrosis space to the collaboration. Under the expanded agreement, the Company will receive a payment from Merck for the in-license of the program directed at a second undisclosed NASH target. Moreover, the Company will receive an additional payment if a third target is designated for the collaboration. With respect to each target in the collaboration, the Company will be eligible to receive up to approximately $460.0 million in development and commercialization milestones as well as tiered royalties on net sales.