Clene Inc. Signs Fourth-Year NIH Subaward with NYU

Clene Inc. has entered into a subaward amendment with New York University for the fourth year of its National Institute of Health grant, securing funding of up to $7.2 million for the period from September 1, 2026, to August 31, 2027. The company, which trades under the ticker CLNN on the Nasdaq Capital Market, disclosed the agreement in a Form 8-K filed with the Securities and Exchange Commission on October 20, 2026. The subaward was signed by Clene Nanomedicine, Inc., a wholly owned subsidiary of Clene Inc.

The funding supports an Expanded Access Program for CNM-Au8 treatment of amyotrophic lateral sclerosis, originally awarded under the Accelerating Access to Critical Therapies for ALS Act. This latest amendment continues a multi-year collaboration that began with a four-year, $45.1 million grant announced in October 2023. The initial grant was awarded in collaboration with Synapticure, a neurology specialty health clinical partner.

The structure of the grant has evolved through successive subaward agreements with different prime awardees. In April 2024, Clene secured a first-year subaward with Columbia University for up to $7.3 million, covering the period from September 25, 2023, to August 31, 2024. The following year, a January 2025 amendment extended the collaboration with Columbia for the second year, providing up to $8.0 million for the period from September 1, 2024, to August 31, 2025.

For the third year of the grant, Clene shifted its prime awardee to New York University. A March 2026 agreement provided up to $8.0 million for the period from September 1, 2025, to August 31, 2026. The current fourth-year amendment maintains NYU as the prime awardee but adjusts the funding amount down to $7.2 million for the upcoming fiscal year.

The company stated that other terms of the subaward, as previously disclosed in a Form 8-K filed on March 16, 2026, remain in full force and effect. The full text of the subaward amendment is filed as Exhibit 10.1 to the current report and is incorporated by reference. The document notes that the description provided does not purport to be complete and is qualified by reference to the actual agreement text.