AJ201
On April 24, 2025 (the “Effective Date”), Avenue and AnnJi Pharmaceutical Co., Ltd. entered into a License Termination and Program Transfer Agreement, pursuant to which the 2023 License Agreement (and related agreements) was terminated, Avenue transferred to AnnJi all of its rights, title and interest to and under the assets arising under the 2023 License Agreement and otherwise related to AJ201, and other terms as disclosed in Avenue’s 8-K filing with the SEC on April 30, 2025. Under the License Termination and Program Transfer Agreement, Avenue will repurchase all shares of Avenue common stock that are held by AnnJi for $1.00, and Avenue also made a payment of $0.2 million to AnnJi as consideration for legal expenses.
AnnJi agreed to make payments to Avenue of $2.0 million in the aggregate over the next 90 days, with $1.0 million due within 30 days after the Effective Date and $1 million due within 90 days after the Effective Date. Additionally, Avenue will be eligible to receive from AnnJi:
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- payments totaling up to $5 million in the aggregate upon the occurrence of certain development and regulatory milestone events pertaining to AJ201;
- payments totaling up to $17 million in the aggregate upon AJ201 experiencing certain commercial sales milestone events;
- a 1.75% royalty on net sales of AJ201, which royalty percentage is subject to potential diminution in certain circumstances; and
- in the event that AnnJi enters into one or more subsequent licenses of rights to AJ201 with third party licensee(s), 15% of payments received by AnnJi from such licensee(s), up to a cap of $7.5 million, and with a minimum of $4 million owing under certain mechanism in the event of an approval of a New Drug Application in the U.S. with respect to AJ201.
For additional details, please refer to Avenue’s 8-K filing with the SEC on April 30, 2025.
AJ201 is currently being studied in a Phase 1/2a multicenter, randomized, double-blind clinical trial in six clinical sites across the U.S., which aims to evaluate the safety, PK/PD data and clinical response of AJ201 in patients suffering from SBMA. The 12-week, multicenter, randomized, double-blind Phase 1b/2a clinical trial of AJ201 is expected to enroll approximately 24 patients, randomly assigned to AJ201 (600 mg/day) or placebo. The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Secondary endpoints include pharmacodynamic data measuring change from baseline in mutant AR protein levels in skeletal muscle and changes in the fat and muscle composition as seen on MRI scans, which are believed to be biomarkers indicating likelihood for longer term clinical improvement. Further details about this study can be found at ClinicalTrials.gov (Identifier: NCT05517603).
