Clene Closes $7.3M Direct Offering, Private Placements, and Amends Debt Facility

Clene Inc. (Nasdaq: CLNN), a clinical-stage biopharmaceutical company dedicated to enhancing mitochondrial health and safeguarding neuronal function to combat neurological diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), has recently concluded a significant financial maneuver. The company has successfully closed a registered direct offering alongside concurrent private placements, collectively raising $7.3 million through the issuance of common stock and warrants. This funding round saw the participation of a healthcare-focused institutional investor, SymBiosis, founding investor Kensington Capital Holdings, Clene's Chairman of the Board, Chief Executive Officer, Chief Scientific Officer, and Founder, as well as support from several existing shareholders.

In addition to the equity financing, Clene has revised its debt facility with Avenue Venture Opportunities Fund, L.P. ("Avenue"). The amendment involves reducing or deferring future principal payments and extending the principal amortization period and the maturity date into the first half of 2025. The combined efforts from the offering and the amended debt facility are projected to sustain Clene’s operations until the first quarter of 2025. This financial strategy will allow Clene to navigate pivotal milestones, including a significant meeting with the U.S. Food and Drug Administration (FDA) to explore the possibility of filing a new drug application (NDA) under the accelerated approval pathway for CNM-Au8®, a gold nanocrystal suspension designed to improve the survival and function of central nervous system cells.

David Matlin, Clene's Chairman of the Board, expressed gratitude towards both new and existing investors, highlighting that the raised capital and deferred debt payments will enable the company to remain financially stable while engaging in critical discussions with the FDA about potentially filing an NDA for CNM-Au8 by the end of the year. Matlin emphasized that this financing will also ensure that patients with ALS currently receiving CNM-Au8 under compassionate use programs will continue to access the drug while Clene discusses its data with the FDA.

Clene Inc., through its subsidiary Clene Nanomedicine Inc., is dedicated to developing innovative treatments aimed at improving mitochondrial health and protecting neuronal function. Their lead candidate, CNM-Au8®, is a pioneering therapy that enhances the survival and function of central nervous system cells by targeting mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8® is a trademarked investigational therapy of Clene Nanomedicine, Inc. Clene is headquartered in Salt Lake City, Utah, with research and development as well as manufacturing operations located in Maryland.

Clene's strategic financial initiatives, including the recent funding round and debt facility amendment, represent a crucial step in advancing their clinical programs and sustaining their operational activities. The anticipated discussion with the FDA regarding the accelerated approval pathway for CNM-Au8 marks a significant milestone in Clene's journey towards providing novel therapeutic options for patients suffering from neurodegenerative diseases. The company's focus remains on demonstrating the efficacy and safety of its drug candidates, navigating regulatory approvals, and ultimately achieving commercial success to address substantial unmet medical needs in the field of neurodegeneration.

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