STOCK TITAN

Clene Inc. - CLNN STOCK NEWS

Welcome to our dedicated page for Clene news (Ticker: CLNN), a resource for investors and traders seeking the latest updates and insights on Clene stock.

Clene Inc. (Nasdaq: CLNN) is a clinical-stage biopharmaceutical company leading the forefront of innovative treatments for neurodegenerative diseases. Utilizing their patented clean-surfaced nanotechnology (CSN), Clene has developed a groundbreaking electro-crystal-chemistry drug development platform, which produces stable, clean-surfaced nanocrystal suspensions. This cutting-edge technology allows for the creation of therapeutic nanoparticles designed to treat conditions such as amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis (MS).

Headquartered in Salt Lake City, Utah, Clene operates with additional research and development facilities in Maryland. Their flagship product, CNM-Au8®, is a first-in-class investigational therapy that enhances mitochondrial health, thus protecting neuronal function. CNM-Au8® targets the central nervous system, facilitating improved cellular survival and function through mechanisms involving the NAD pathway and reduction of oxidative stress.

Recent significant achievements include:

  • VISIONARY-MS Trial: Clene reported sustained improvement in vision and cognitive function in patients with stable relapsing MS during the long-term extension phase of the trial, demonstrating the potential of CNM-Au8® to improve neurological outcomes.
  • ALS Expanded Access Program (EAP): Clene's EAP has shown promising survival benefits for individuals with advanced ALS, highlighting the robust efficacy and safety of CNM-Au8®.
  • NIH Funding: Clene secured a substantial four-year grant from the National Institutes of Health to support an expanded access program for ALS, emphasizing the recognition and support from the broader medical and scientific community.
  • Financial Position: As of the end of 2023, Clene reported $35 million in cash and equivalents, ensuring sufficient funding to advance their operations through 2024.

Clene continues to build on its promising clinical data, aiming to move CNM-Au8® into Phase 3 trials and potentially bring new hope to patients suffering from neurodegenerative diseases. For more information, visit Clene's website or follow them on social media platforms such as X (formerly Twitter) and LinkedIn.

Rhea-AI Summary

Clene Inc. (CLNN) has secured a new $10 million debt facility to replace its existing $7.85 million Avenue Capital debt. The new facility carries a 12% annual interest rate and is secured by all company assets. Notable features include:

- Interest-only payments for the first 12 months
- 18-month maturity period
- 65% of the debt is convertible to common stock at $5.67 per share (130% premium to closing price)

The financing aims to improve Clene's cash position to support additional data generation for CNM-Au8®'s new drug application for ALS through an accelerated regulatory pathway. The debt facility is provided by three Clene-affiliated entities and is expected to close by December 20, 2024.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
4.37%
Tags
none
-
Rhea-AI Summary

Clene Inc. (CLNN) received FDA guidance regarding a potential accelerated approval pathway for CNM-Au8® in ALS treatment. The FDA recommended leveraging additional Neurofilament Light (NfL) data from Expanded Access Protocols (EAPs) and the HEALEY ALS Platform Trial to support earlier findings. Key developments include:

- Planned NDA submission in mid-2025 following EAP NfL biomarker analyses
- Additional NfL biomarker collection and analyses to be completed by Q2 2025
- Commencement of confirmatory Phase 3 RESTORE-ALS trial before NDA submission
- Demonstrated 78% risk reduction in time to death during Open Label Extension
- Strong safety profile with no significant concerns in over 700 patient years

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.79%
Tags
-
Rhea-AI Summary

Clene Inc. (NASDAQ: CLNN) reported Q3 2024 financial results with cash and equivalents of $14.6 million as of September 30, 2024. The company completed a $7.3 million registered direct offering in October 2024 and amended its debt agreement with Avenue Capital, extending maturity to Q2 2025. R&D expenses decreased to $4.5 million from $6.0 million year-over-year, while G&A expenses reduced to $3.4 million from $3.7 million. The company reported a net loss of $8.0 million ($1.22 per share) compared to $2.4 million ($0.38 per share) in Q3 2023.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-9.06%
Tags
Rhea-AI Summary

Clene Inc. (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurological diseases like ALS and MS, has announced its participation in two upcoming investor conferences in October 2024.

The company will attend the 2024 Maxim Healthcare Virtual Summit from October 15-17, with a fireside presentation scheduled for October 15 at 2:30 p.m. E.T. Clene will also participate in The ThinkEquity Conference 2024 on October 30 in New York City, presenting at 3:30 p.m. E.T.

Both events will feature presentations and one-on-one meetings. For the Maxim Healthcare Virtual Summit, interested parties can sign up to become M-Vest members. The ThinkEquity Conference presentation will be accessible via webcast.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
14.04%
Tags
conferences
-
Rhea-AI Summary

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.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
6.3%
Tags
-
Rhea-AI Summary

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.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-4.77%
Tags
Rhea-AI Summary

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.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-17.06%
Tags
-
Rhea-AI Summary

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.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
12.33%
Tags
conferences
-
Rhea-AI Summary

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.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-23.47%
Tags
Rhea-AI Summary

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.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
47%
Tags

FAQ

What is the current stock price of Clene (CLNN)?

The current stock price of Clene (CLNN) is $5 as of December 24, 2024.

What is the market cap of Clene (CLNN)?

The market cap of Clene (CLNN) is approximately 39.9M.

What does Clene Inc. specialize in?

Clene Inc. specializes in developing and commercializing clean-surfaced nanotechnology (CSN) therapeutics aimed at treating neurodegenerative diseases like ALS, Parkinson's, and MS.

What is CNM-Au8®?

CNM-Au8® is Clene's investigational therapy composed of gold nanocrystals designed to improve mitochondrial health and neuronal function by targeting the NAD pathway and reducing oxidative stress.

Where is Clene Inc. located?

Clene Inc. is headquartered in Salt Lake City, Utah, with additional research and development and manufacturing operations in Maryland.

What recent achievements has Clene Inc. reported?

Recent achievements include significant improvements in MS patient outcomes from the VISIONARY-MS trial, survival benefits in ALS from expanded access programs, and securing a major NIH grant.

What is the significance of the NIH funding for Clene?

The NIH funding supports an expanded access program for ALS, acknowledging Clene's innovative approaches and providing resources to treat more patients with CNM-Au8®.

How stable is Clene Inc.'s financial status?

As of the end of 2023, Clene reported $35 million in cash and equivalents, ensuring sufficient funding for operations through 2024.

What is unique about Clene's clean-surfaced nanotechnology?

Clene's clean-surfaced nanotechnology creates high-purity nanocrystal suspensions that improve therapeutic outcomes by enhancing mitochondrial function and reducing oxidative stress.

How has CNM-Au8® performed in clinical trials?

In clinical trials, CNM-Au8® has shown improvements in vision, cognitive function, and overall neurological health in patients with MS and ALS, with consistent safety and tolerability.

What are Clene’s future plans for CNM-Au8®?

Clene plans to advance CNM-Au8® into Phase 3 clinical trials to further validate its efficacy and safety, with the aim of obtaining regulatory approval for broader clinical use.

Where can I get more information about Clene Inc.?

More information about Clene Inc. can be found on their website at www.clene.com, as well as their social media profiles on X (formerly Twitter) and LinkedIn.

Clene Inc.

Nasdaq:CLNN

CLNN Rankings

CLNN Stock Data

39.90M
5.68M
28.28%
12.91%
1.6%
Packaged Foods
Pharmaceutical Preparations
Link
United States of America
SALT LAKE CITY