Clene Inc. (NASDAQ: CLNN) Closes $7.3 Million Registered Direct Offering and Concurrent Private Placements

• Proceeds from the offerings will support the company’s operations into the first quarter of 2025.
• Clene also amended its existing debt facility with Avenue Venture Opportunities Fund, L.P. to reduce or defer future monthly principal payments and to extend principal amortization period and the final maturity date into the first half of 2025.
• The company’s lead drug candidate, CNM-Au8^® has been shown to restore and protect neurological function, offering new hope for patients with ALS and other neurodegenerative conditions.
• Clene is seeking an accelerated approval pathway for CNM-Au8 for ALS, with a meeting scheduled with the FDA before the end of November.

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) multiple sclerosis (“MS”) and Parkinson’s Disease (“PD”), announced the successful closing of a $7.3 million registered direct offering and concurrent private placements, designed to boost its capital position during a crucial phase in its on-going operations.

The registered direct offering and concurrent private placements of common stock and warrants with a healthcare-focused institutional investor and existing shareholders, including insiders, brought total gross proceeds of $7.3 million, with the potential for additional capital in the future through the exercise of warrants (https://ibn.fm/m8dCM).

The offering was led by a healthcare-focused institutional investor with participation from SymBiosis; founding investor Kensington Capital Holdings; Clene’s Chairman of the Board of Directors, Chief Executive Officer and Chief Scientific Officer and Founder; along with support from several other previously existing shareholders.

Clene also announced an amendment of its existing debt facility with Avenue Venture Opportunities Fund, L.P. such that future monthly principal payments are reduced or deferred, and the principal amortization period and maturity date of the loan will be extended into the first half of 2025.

This financing and debt restructuring is expected to provide Clene with essential funding for its operations into the first quarter of 2025 which will support upcoming regulatory milestones, including the upcoming meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the potential to file a new drug application for lead candidate CNM-Au8 for ALS under an accelerated approval pathway.

This financing follows two encouraging Phase 2 clinical trials, RESCUE-ALS and HEALEY ALS Platform Trials, where participants who were administered CNM-Au8, saw significant improvement in survival rates, functional status and combined assessment of function and survival.

Developed as an oral suspension of gold nanocrystals, CNM-Au8 works by improving cellular energy production and utilization, which is critical for maintaining neuronal health. In both clinical trials and compassionate use programs, CNM-Au8 has already been shown to improve central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the nicotinamide adenine dinucleotide (“NAD”) pathway while reducing oxidative stress. By targeting mitochondrial dysfunction, CNM-Au8 aims to provide neuroprotection and promote remyelination, potentially altering the course of neurodegenerative conditions.

Commenting on the closing of the financing and upcoming plans, Chairman of the Board David Matlin said the company appreciated the support it obtained from its new healthcare-focused institutional investor as well as existing shareholders. “The capital raised in this offering along with the debt principal deferral from Avenue will allow the company to fund itself while in discussions with the FDA to potentially file an NDA under the accelerated approval pathway by year end,” Matlin added. “Most importantly, this financing also enables people with ALS who currently take CMN-Au8 under our compassionate use programs to continue receiving drug while Clene discusses its data with the FDA.”

For more information, visit the company’s website at www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

About BioMedWire

BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.

BMW is where breaking news, insightful content and actionable information converge.

To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only)

For more information, please visit https://www.BioMedWire.com

Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/Disclaimer

BioMedWire
San Francisco, CA
www.BioMedWire.com
415.949.5050 Office
Editor@BioMedWire.com

BioMedWire is powered by IBN