Clene Stock Price, News & Analysis

Clene Inc. (Nasdaq: CLNN) has announced the closing of a $7.3 million registered direct offering and concurrent private placements of common stock and warrants. The offering was led by a healthcare-focused institutional investor with participation from existing shareholders, including insiders. Additionally, Clene amended its debt facility with Avenue Venture Opportunities Fund, L.P., reducing or deferring future monthly principal payments and extending the maturity date into the first half of 2025.

The combined financing is expected to fund the company's operations into the first quarter of 2025, enabling key milestones such as a face-to-face meeting with the FDA to discuss the potential filing of a new drug application for CNM-Au8® under an accelerated approval pathway. This funding also allows continued provision of CNM-Au8 to ALS patients under compassionate use programs while Clene discusses its data with the FDA.

Clene Inc. (Nasdaq: CLNN) announced a $7.3 million registered direct offering and concurrent private placements on September 30, 2024. The company is issuing:
- 742,626 shares (or pre-funded warrants) to a healthcare-focused institutional investor at $4.713 per share
- 681,469 shares (or pre-funded warrants) to existing stockholders at $4.713 per share
- 122,819 shares to directors and officers at $4.875 per share

All offerings include warrants to purchase an equal number of shares at $4.82 per share, exercisable immediately and expiring in five years. Clene plans to use the proceeds for general corporate purposes, including funding the clinical development of CNM-Au8®, potential commercialization efforts, and regulatory activities. Canaccord Genuity is acting as the sole placement agent, with the offerings expected to close around October 1, 2024.

Clene Inc. (Nasdaq: CLNN) has secured an in-person meeting with senior FDA leadership to discuss its CNM-Au8 development for ALS. The meeting, scheduled before the end of November 2024, will include key FDA officials and opinion leaders in ALS, biostatistics, and biomarkers. This development comes after the FDA initially communicated that Clene's briefing package did not support an NDA submission under the accelerated approval pathway. However, the FDA agreed to reassess the submission in person.

Clene will present data on ALS biomarkers, clinical endpoints, and survival data for CNM-Au8. The company has accumulated over 700 patient-years of safety data for CNM-Au8, showing no significant safety concerns or trends. No serious adverse events related to CNM-Au8 treatment have been identified by clinical trial investigators to date.

Clene Inc. (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focusing on neurodegenerative diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company, which specializes in improving mitochondrial health and protecting neuronal function, will present virtually on September 9, 2024, at 7:00 am EST.

Clene's management will deliver a presentation and host one-on-one investor meetings during the conference. Investors interested in scheduling meetings are advised to contact their H.C. Wainwright representative. A webcast of the presentation will be accessible through the 'Events' section of Clene's website, with an additional online registration option available for viewing.

Clene Inc. (Nasdaq: CLNN) reported its Q2 2024 financial results and updates on CNM-Au8® programs. Key highlights:

1. Improved survival in CNM-Au8 30 mg treated ALS patients compared to controls.
2. Significant clinical improvements in CNM-Au8 NfL Responders.
3. Neuroprotective effects demonstrated in Rett Syndrome model.
4. First ALS patient enrolled in NIH-funded Expanded Access Program.
5. Regained Nasdaq listing compliance.
6. FDA Type C interaction scheduled for Q3 2024.

Financial results: Cash and equivalents of $21.7M as of June 30, 2024. Q2 net loss of $6.8M ($1.06 per share), compared to $25.1M ($5.84 per share) in Q2 2023. R&D expenses decreased to $4.2M from $6.6M year-over-year.

Clene Inc. (Nasdaq: CLNN) has submitted new CNM-Au8 biomarker and clinical efficacy data to the FDA for ALS treatment. Key findings include:

1. CNM-Au8 NfL Responders showed significant improvements in survival, functional status, and combined function and survival.

2. Long-term CNM-Au8 treatment demonstrated substantial survival benefits compared to matched controls.

3. NAD and glutathione improvements were consistent with CNM-Au8 treatment, supporting its dual mechanism of action.

4. Safety profile remains strong with no significant concerns identified over 650 patient years of data.

These results aim to support discussions with the FDA for an accelerated approval pathway for CNM-Au8 in ALS treatment.

Clene Inc. (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focusing on neurodegenerative diseases, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase. The event is scheduled for August 13, 2024, with Clene's presentation set for 11:30 am EST.

Clene specializes in improving mitochondrial health and protecting neuronal function to treat conditions such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The company's management will deliver a presentation and host one-on-one investor meetings during the conference.

Interested parties can access a webcast of the presentation through Clene's website in the 'Events' section or via a provided registration link.

Clene (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, such as ALS and MS, will present at the Emerging Growth Conference. The virtual presentation is scheduled for July 18, 2024, at 4:45 p.m. EDT and will include a corporate update and Q&A session. The webcast will be available on Clene's website and the Emerging Growth YouTube Channel. The Emerging Growth Conference is designed to connect public companies with investors, featuring companies from various growth sectors. Clene's investigational therapy, CNM-Au8®, targets mitochondrial function to improve cell survival and reduce oxidative stress. Based in Salt Lake City, Clene also has R&D and manufacturing operations in Maryland.

Clene announced plans to submit a briefing book to the FDA by July 13, 2024, ahead of a Type C interaction scheduled for Q3 2024. The aim is to gain feedback on the accelerated approval pathway for CNM-Au8®, intended to treat ALS. The briefing book includes post-hoc analyses from completed clinical studies, focusing on neurofilament light (NfL) biomarker reduction, matured survival data, and evidence of CNM-Au8’s mechanism of action. These analyses address prior FDA comments and aim to demonstrate CNM-Au8’s potential for accelerated approval. Further data insights will be shared publicly later in 2024, and Clene will announce the FDA's feedback after the Type C interaction.