Clene Inc. - Common Stock (CLNN)

Clene Inc. (NASDAQCLNN) 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”) and multiple sclerosis (“MS”), has signed an agreement with APST Research GmbH (“APST”) to support analyses of CNM-Au8’s effects on NfL decline in participants in ongoing EAPs ( https://ibn.fm/2IwhG ). The analyses were recommended by the U.S. Food and Drug Administration (“FDA”) to support Clene’s data package for a potential accelerated approval application.

Clene (NASDAQCLNN) announced that CEO Rob Etherington and CFO Morgan Brown will present at the Investor Summit Virtual on March 11, 2025. The event will provide investors with insights into the company’s latest developments and strategic outlook.

Mullen Automotive (NASDAQMULN) announced the purchase and delivery of its Mullen ONE Class 1 EV cargo van to Orange County, North Carolina, for deployment by the county’s Solid Waste Management Department. The order, fulfilled by National Auto Fleet Group, supports Orange County’s Climate Action Plan to transition its fleet to all-electric by 2025. Mullen’s commercial EVs, including the Mullen ONE and Mullen THREE, are available for purchase under Sourcewell’s contract, offering sustainable solutions for government agencies nationwide.

NEW YORK, NY / ACCESS Newswire / February 27, 2025 / Rob Etherington, CEO, and Morgan Brown, CFO, of Clene Inc., will be presenting at this year's Investor Summit Virtual on March 11th.

Clene (NASDAQCLNN) has entered into an agreement with Germany-based APST Research GmbH to utilize its extensive neurofilament light chain (NfL) database in FDA-recommended analyses of CNM-Au8® for treating amyotrophic lateral sclerosis (ALS). APST’s repository includes biomarker data from over 4,300 ALS patients, which will help Clene compare NfL changes in NIH-sponsored Expanded Access Protocol participants to matched controls. The results could support Clene’s planned New Drug Application submission for CNM-Au8 under the FDA’s Accelerated Approval pathway in the second half of 2025. CEO Rob Etherington emphasized the importance of leveraging real-world evidence to advance potential treatments for ALS.

A new study has determined that a medication normally prescribed for multiple sclerosis can help persons with poor working memory. Working memory is an important component of cognitive function. Sadly, it is often impaired in patients with conditions like schizophrenia.

New research has found that a toxic protein may affect the skeletal muscle tissues, spinal cord, and brain, aiding the development and progression of amyotrophic lateral sclerosis .

Funded by the U.S. Department of Defense, a new study will be conducted to examine why individuals, especially veterans, who suffer from a certain sleep disorder often end up developing Parkinson’s disease . The DoD awarded $4 million to researchers at Oregon Health and Science University (OSHU), the VA Healthcare System at Portland, the VA Sound Healthcare System at Puget, and the University of Washington to conduct this study.

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Clene (NASDAQCLNN) 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 recently secured a new $10 million debt facility, which enables the payoff of another higher interest rate loan and the finance of operations to generate additional data to support the new drug application of lead drug candidate CNM-Au8 for ALS.

As an individual grows older, they experience continued loss of strength and skeletal muscle mass. Once an adult reaches 40, they start losing roughly 8% of their muscle mass every 10 years. By age 70, this often rises to 15% loss in muscle mass every 10 years.

Clene (NASDAQCLNN) 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”) and multiple sclerosis (“MS”), recently received additional written guidance and a roadmap from the U.S. Food and Drug Administration’s (“FDA”) Division of Neurology 1 regarding a potential accelerated approval pathway for lead drug candidate CNM-Au8 in ALS. “The FDA guidance on a potential path to meet the regulatory standard for substantial evidence of effectiveness supporting accelerated approval came following an in-person Nov. 1 Type C meeting with the DN1 where the company presented additional clinical trial data and analyses. The FDA recommended that Clene leverage additional Neurofilament Light (‘NfL’) data from its three Expanded Access Programs (‘EAPs’) to support earlier findings,” reads an article discussing the guidance.

Parkinson’s disease is a neurodegenerative condition that affects an individual’s brain, causing issues with their movement, sleep and mental health. Common symptoms include tremors, slowed movements and issues with balance.

Clene (NASDAQCLNN) 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 ).

Clene (NASDAQCLNN) has announced a $10 million debt facility with three affiliated entities, set to close by December 20, 2024. The 18-month secured, partially convertible note carries a 12% fixed interest rate, with an interest-only period for the first year. Sixty-five percent of the note is convertible into common stock at $5.67 per share, a 130% premium over the stock’s signing day closing price. Proceeds will support Clene’s development of its CNM-Au8 treatment for ALS and neurodegenerative diseases, addressing FDA data requirements for regulatory approval. The company also aims to repay its prior $7.9 million Loan Agreement with Avenue Venture Opportunities Fund.

Clene (NASDAQCLNN) 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”) and multiple sclerosis (“MS”), has received additional written guidance and a roadmap from the U.S. Food and Drug Administration’s (“FDA”) Division of Neurology 1 regarding a potential accelerated approval pathway for lead drug candidate CNM-Au8 in ALS ( https://ibn.fm/8VQGo ).

Glioblastoma multiforme is an aggressive type of cancer that usually affects an individual’s spinal cord or brain. Brain cancers, which are among the most difficult cancers to treat, are the primary cause of cancer deaths in kids.

Clene (NASDAQCLNN) received FDA guidance on leveraging data from its ongoing expanded access programs (“EAPs”) to support an accelerated approval application for CNM-Au8, its treatment for ALS. The FDA recommended using neurofilament light chain (“NfL”) biomarker analyses to substantiate the drug’s efficacy. Clene plans to submit additional data in mid-2025, alongside commencing the Phase 3 RESTORE-ALS trial. Clinical findings presented at an FDA meeting highlighted CNM-Au8’s significant survival benefits and benign safety profile, underscoring its potential as a transformative ALS therapy. Clene remains committed to addressing the urgent unmet needs of ALS patients.

Clene (NASDAQCLNN) reported its Q3 2024 financial results and provided updates on its CNM-Au8 programs. Key operational highlights included a recent FDA meeting to discuss the potential for accelerated approval of CNM-Au8 for ALS, a 1-for-20 reverse stock split to meet Nasdaq requirements, an amended debt facility extending funding into Q2 2025, and a $7.3 million funding round. Clene’s Phase 3 RESTORE-ALS trial was presented in October, showcasing the company’s commitment to ALS treatment innovation. Financially, Clene ended Q3 with $14.6 million in cash and reported an $8.0 million net loss, reflecting decreased R&D and G&A expenses, but lower gains on warrant liability adjustments compared to 2023.

Last week, the European Commission announced that it had imposed a half-a-billion dollar fine on Teva, a multinational pharmaceutical firm based in Israel. The company, which specializes in generic drugs, is said to have artificially extended patent protection for its multiple sclerosis drug known as Copaxone. The drug has glatiramer acetate as its active ingredient.

Clene (NASDAQCLNN) 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”) and multiple sclerosis (“MS”), recently announced an upcoming meeting with U.S. Food and Drug Administration (“FDA”) leadership. The focus is to discuss Clene’s CNM-Au8® biomarker and related clinical and survival data for ALS. “FDA’s Director of the Office on New Drugs, the Director of the Office of Neuroscience, and the Division of Neurology 1 (‘DN1’) review team, as well as recognized key opinion leaders in ALS, biostatistics and biomarkers,” will attend the meeting according to a recent article.

Clene (NASDAQCLNN) 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”), is participating in two top investor conferences this month to present its latest achievements and key updates on its lead drug candidate, CNM-Au8 ( https://ibn.fm/BDqtM ).

Clene (NASDAQCLNN) 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.

Clene (NASDAQCLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a 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”). Clene announced Wednesday morning that it will participate in two investor conferences this month.

Clene (NASDAQCLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, and its wholly owned subsidiary, Clene Nanomedicine Inc., has closed on a registered direct offering and concurrent private placements. According to the announcement, the transactions consist of common stock and warrants and were with a healthcare-focused institutional investor and existing shareholders, including insiders. Gross proceeds of the offerings and placements totaled an estimated $7.3 million with the potential for additional capital through the future exercise of warrants. Clene also announced the amendment of its existing debt facility with Avenue Venture Opportunities Fund, L.P.