Clene Inc. secures additional NIH grant funds for ALS therapy

Published 30/01/2025, 23:46
Clene Inc. secures additional NIH grant funds for ALS therapy

Salt Lake City-based pharmaceutical company Clene Inc. has amended its grant subaward with Columbia University, securing up to $8 million in additional funding for the second year of its amyotrophic lateral sclerosis (ALS) treatment program. The amendment, disclosed in a recent SEC filing, extends the financial support for the period from September 1, 2024, to August 31, 2025. The additional funding comes at a crucial time for Clene, which according to InvestingPro data, faces significant cash burn challenges with a current ratio of 0.83, indicating its short-term obligations exceed liquid assets.

This financial boost is part of the National Institute of Health’s (NIH) $45.1 million grant, initially announced on October 5, 2023, under the Accelerating Access to Critical Therapies for ALS Act. Clene Inc., along with its subsidiary Clene Nanomedicine, Inc., collaborates with Columbia University and Synapticure, a specialized neurology clinic, on the Expanded Access Program (ACT-EAP) for CNM-Au8, a treatment for ALS.

The Subaward Amendment 1, filed with the SEC on January 28, 2025, ensures the continuation of the ACT-EAP. While the amendment focuses on financial details, the other terms of the initial subaward agreement remain unchanged. The full text of the amendment can be found in Exhibit 10.1 of the SEC filing.

Clene Inc.’s common stock and warrants are traded on The Nasdaq Capital Market under the tickers (NASDAQ:CLNN) and NASDAQ:CLNNW, respectively. The company, formerly known as Chelsea Worldwide Inc., underwent a name change on August 27, 2020.

This development is based on a press release statement and investors can refer to the SEC filing for a detailed account of the grant amendment and its implications for Clene Inc.’s ongoing ALS treatment program.

In other recent news, Clene Inc. has seen adjustments in stock targets and ratings from analyst firms Benchmark and Canaccord Genuity. Both firms have revised their price targets for Clene, with Benchmark reducing its target to $84.00 from $90.00, and Canaccord lowering its target to $83 from $86. Despite these revisions, both firms maintain a Buy rating for Clene’s stock.

These adjustments come after a meeting between Clene’s management and the U.S. Food and Drug Administration (FDA) to discuss the potential for an accelerated approval pathway for Clene’s drug CNM-Au8, aimed at treating Amyotrophic Lateral Sclerosis (ALS). The company is currently awaiting minutes from this FDA meeting, which could significantly impact the time it takes for CNM-Au8 to reach the market.

In addition to the FDA meeting, Clene’s third-quarter financial report, which included new share count assumptions, played a part in the updated valuation models leading to the lower price targets. The company has also secured approximately $7.3 million through stock and warrant sales, which are expected to support the clinical development of CNM-Au8.

Lastly, Clene has also modified its loan agreement with Avenue Venture Opportunities Fund, L.P., reducing the principal payment due in October 2024. These are the recent developments for Clene Inc.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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