Clene Inc. (NASDAQ: CLNN) to Highlight Latest Achi
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Posted On: 03/05/2025 3:51:10 PM
Clene Inc. (NASDAQ: CLNN) to Highlight Latest Achievements, Next Steps for CNM-Au8(R), at Q1 Virtual Investor Summit on March 11
- The Q1 Virtual Investor Summit will focus on microcap companies that are undervalued, and aim to create connections between leading investors and microcap companies
- Clene’s presentation will be given by CEO Rob Etherington and CFO Morgan Brown
- Clene’s participation in the event comes as the company is moving closer to submitting a New Drug Application to the FDA to secure potential accelerated approval for CNM-Au8® for ALS
- The company recently partnered with German-based APST Research GmbH to analyze neurofilament light chain (“NfL”) data for evaluating CNM-Au8 efficacy in ALS patients.
Clene Inc. (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”), and multiple sclerosis (“MS”), will attend the Q1 Virtual Investor Summit event on March 11 to showcase its latest achievements and outline the next steps for lead drug candidate CNM-Au8 (https://nnw.fm/3RMnM ).
The company’s presentation will be given by CEO Rob Etherington and CFO Morgan Brown. The presentation starts at 1 p.m. ET. Anyone interested in participating can register at https://nnw.fm/ll88J.
The Q1 Investor Summit will consist of company presentations between 9 a.m. and 4 p.m. ET, along with one-on-one meetings between 8 a.m. and 4 p.m. An exclusive event for investors who specialize in small and microcap stocks, the Summit is a unique opportunity for investors to be introduced to and speak with management at some of the most attractive small companies, learn from various subject matter experts, and see what their peers are doing in this market. This quarter’s event focuses on microcap companies that are undervalued.
Clene’s participation in the event comes as the company is moving closer to submitting an NDA (New Drug Application) to the Food and Drug Administration (“FDA”) in the second half of 2025 to secure potential accelerated approval for CNM-Au8 for ALS.
CNM-Au8 is an oral suspension of gold nanocrystals designed to improve cellular energy production and utilization, which is critical for maintaining neuronal health. The drug candidate has been shown to improve central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the nicotinamide adenine dinucleotide pathway while reducing oxidative stress. By targeting mitochondrial dysfunction, CNM-Au8 can provide neuroprotection and promote remyelination.
The drug candidate has a robust safety profile and has provided evidence of survival benefit from two independent, randomized, double-blind, placebo-controlled clinical trials so far. In these two Phase 2 clinical trials, RESCUE-ALS and the HEALEY ALS Platform Trial, Regimen C, participants who were administered CNM-Au8 saw significant improvement in survival rates, delayed time to clinical worsening, and improvements on the combined assessment of function and survival compared to placebo. These results are supported by declines in the key plasma biomarker, NfL.
The company recently signed an agreement with APST Research GmbH (“APST”) to further analyze NfL data. The data will support analyses recommended by the FDA on the effects of CNM-Au8 in an additional cohort of ALS patients. Clene will use APST’s extensive dataset to compare NfL levels in NIH-sponsored Expanded Access Protocol (“EAP”) participants treated with CNM-Au8 against matched historical ALS controls. The goal is to determine if CNM-Au8 treatment reduces NfL decline, and to demonstrate that the rate of NfL change is associated with survival in the NIH-sponsored EAP ALS population, which would further strengthen Clene’s case for regulatory approval.
There is currently no cure available for ALS, and treatments can only help slow down the disease progression, manage the symptoms, and prevent unnecessary complications. CNM-Au8 can help increase and improve survival rates in ALS patients by enabling the body’s main systems, primarily breathing, to continue. An accelerated approval pathway for CNM-Au8 would offer hope and help obtain the best outcome for people living with ALS, the company believes. According to CDC statistics, approximately 5,000 Americans are diagnosed with ALS each year, and about 30,000 people are currently living with the disease in the U.S. alone (https://nnw.fm/PVYDP ).
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://nnw.fm/CLNN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
- The Q1 Virtual Investor Summit will focus on microcap companies that are undervalued, and aim to create connections between leading investors and microcap companies
- Clene’s presentation will be given by CEO Rob Etherington and CFO Morgan Brown
- Clene’s participation in the event comes as the company is moving closer to submitting a New Drug Application to the FDA to secure potential accelerated approval for CNM-Au8® for ALS
- The company recently partnered with German-based APST Research GmbH to analyze neurofilament light chain (“NfL”) data for evaluating CNM-Au8 efficacy in ALS patients.
Clene Inc. (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”), and multiple sclerosis (“MS”), will attend the Q1 Virtual Investor Summit event on March 11 to showcase its latest achievements and outline the next steps for lead drug candidate CNM-Au8 (https://nnw.fm/3RMnM ).
The company’s presentation will be given by CEO Rob Etherington and CFO Morgan Brown. The presentation starts at 1 p.m. ET. Anyone interested in participating can register at https://nnw.fm/ll88J.
The Q1 Investor Summit will consist of company presentations between 9 a.m. and 4 p.m. ET, along with one-on-one meetings between 8 a.m. and 4 p.m. An exclusive event for investors who specialize in small and microcap stocks, the Summit is a unique opportunity for investors to be introduced to and speak with management at some of the most attractive small companies, learn from various subject matter experts, and see what their peers are doing in this market. This quarter’s event focuses on microcap companies that are undervalued.
Clene’s participation in the event comes as the company is moving closer to submitting an NDA (New Drug Application) to the Food and Drug Administration (“FDA”) in the second half of 2025 to secure potential accelerated approval for CNM-Au8 for ALS.
CNM-Au8 is an oral suspension of gold nanocrystals designed to improve cellular energy production and utilization, which is critical for maintaining neuronal health. The drug candidate has been shown to improve central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the nicotinamide adenine dinucleotide pathway while reducing oxidative stress. By targeting mitochondrial dysfunction, CNM-Au8 can provide neuroprotection and promote remyelination.
The drug candidate has a robust safety profile and has provided evidence of survival benefit from two independent, randomized, double-blind, placebo-controlled clinical trials so far. In these two Phase 2 clinical trials, RESCUE-ALS and the HEALEY ALS Platform Trial, Regimen C, participants who were administered CNM-Au8 saw significant improvement in survival rates, delayed time to clinical worsening, and improvements on the combined assessment of function and survival compared to placebo. These results are supported by declines in the key plasma biomarker, NfL.
The company recently signed an agreement with APST Research GmbH (“APST”) to further analyze NfL data. The data will support analyses recommended by the FDA on the effects of CNM-Au8 in an additional cohort of ALS patients. Clene will use APST’s extensive dataset to compare NfL levels in NIH-sponsored Expanded Access Protocol (“EAP”) participants treated with CNM-Au8 against matched historical ALS controls. The goal is to determine if CNM-Au8 treatment reduces NfL decline, and to demonstrate that the rate of NfL change is associated with survival in the NIH-sponsored EAP ALS population, which would further strengthen Clene’s case for regulatory approval.
There is currently no cure available for ALS, and treatments can only help slow down the disease progression, manage the symptoms, and prevent unnecessary complications. CNM-Au8 can help increase and improve survival rates in ALS patients by enabling the body’s main systems, primarily breathing, to continue. An accelerated approval pathway for CNM-Au8 would offer hope and help obtain the best outcome for people living with ALS, the company believes. According to CDC statistics, approximately 5,000 Americans are diagnosed with ALS each year, and about 30,000 people are currently living with the disease in the U.S. alone (https://nnw.fm/PVYDP ).
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://nnw.fm/CLNN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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