InvestorWire NewsRoom

Article

Clene Inc. (NASDAQ: CLNN) Improves Cash Position and Runway with New Debt Facility for CNM-Au8(R) Data Collection to Support Accelerated Approval Application
December 26, 2024

Clene Inc. (NASDAQ: CLNN) Improves Cash Position and Runway with New Debt Facility for CNM-Au8(R) Data Collection to Support Accelerated Approval Application

  • The $10 million loan agreement, carrying a 12% interest rate and secured by all assets of Clene, was signed with three lenders affiliated with the company.
  • The funds will be used to repay the remaining $7.9 million debt of an Avenue Capital Group loan, and will improve the company’s cash position, enabling it extra runway to generate additional data to support the new drug application of CNM-Au8 for ALS.
  • The FDA earlier suggested that Clene leverage additional neurofilament light (“NfL”) data from the company’s three Expanded Access Protocols (compassionate use programs) and the HEALEY ALS Platform Trial to support earlier clinical trial findings, with a follow-up meeting with the FDA to be held in early 2025.

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). The company has now secured a new $10 million debt facility, enabling the pay-off of another loan at higher interest rates to significantly improve its cash position as well as finance operations to generate of additional data to support the new drug application of lead drug candidate CNM-Au8 for ALS (https://ibn.fm/Maor9).

The new debt facility was signed with three entities affiliated with Clene and was closed on Dec. 20, 2024. Under the terms of the deal, the three lenders provided the aggregate principal amount of $10 million for the secured, partially convertible debt facility, with a fixed interest rate of 12% and a maturity eighteen months after closing. The first 12 twelve months are interest-only. Sixty-five percent of the debt facility is convertible into shares at a fixed conversion price of $5.67, a 130% premium to Clene’s closing stock price on the day of signing.

The funding will be used to pay off the remaining debt of an existing senior loan taken with Avenue Venture Opportunities Fund, L.P., a fund of the Avenue Capital Group, in May 2021. Over the course of the loan agreement, Clene borrowed $20 million. Repayment under the loan agreement began in July 2024 with $7 million of principal outstanding as of December 2024 plus a final payment fee of $0.85 million, for a total payoff of approximately $7.9 million, including a prepayment penalty.

The new loan will help improve the company’s cash position, enabling the cash runway to generate additional biomarker data to support the new drug application of CNM-Au8 for ALS via an accelerated regulatory pathway. The company met with the U.S. Food and Drug Administration (“FDA”) to discuss a potential accelerated regulatory pathway in November and has since received additional guidance from the regulatory body to gather further clinical trial data.

CNM-Au8, an oral suspension of gold nanocrystals, works by improving cellular energy production and utilization, which is critical for maintaining neuronal health. The drug candidate 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. Phase 2 clinical trial data, as presented to the FDA, revealed significant improvement in survival rates, functional status and combined assessment of function and survival.

The FDA recommended that Clene leverage additional NfL data from its three expanded access protocols (“EAPs”) and the HEALEY ALS Platform Trial to support earlier findings. Clene will have another meeting with the FDA in early 2025 to review and finalize its analysis plan for the EAP NfL biomarker analyses.

Commenting on the new debt facility, Clene CEO and President Rob Etherington said the company was grateful for the trust of its long-standing investors who remain supportive of the company’s efforts to provide potentially lifesaving therapies for ALS and other neurodegenerative diseases.

“We believe that the proceeds from this new debt facility, including an extended interest-only period, will allow Clene the cash runway to generate the additional data the U.S. Food and Drug Administration has requested from our expanded access programs,” Etherington added. “The data are being gathered to support the existing clinical study data for inclusion in an application seeking approval of CNM-Au8 for ALS through the accelerated regulatory pathway.”

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 InvestorWire

InvestorWire (“IW”) is a specialized communications platform with a focus on advanced wire-grade press release syndication for private and public companies and the investment community. It is one of 70+ 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, IW 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, IW brings its clients unparalleled recognition and brand awareness. IW is where breaking news, insightful content and actionable information converge.

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

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

InvestorWire
Los Angeles, CA
www.InvestorWire.com
310.299.1717 Office
[email protected]

InvestorWire is powered by IBN

Recent Articles

Release Categories

Get Started with InvestorWire

To distribute a release in the next 24 hours. Contact our client services team.

(862) 930-1404

Distribute a press release. Submit your release to get started.

Submit Press Release

Set up a Live demonstration. Schedule a date and time that works for you.

Schedule a LIVE Demo

Press Distribution

Explore Press Distribution Solutions

All releases include an unlimited word count* with full wire-grade syndication, our press release enhancement service, and a follow-up InvestorNewsBreak article distributed to thousands of editorial syndication partners.

Discover Add-on Solutions

Increase the impact of your achievements by adding these exclusive solutions from InvestorWire, delivered in conjunction with the InvestorBrandNetwork (IBN).