CLNN Clene Inc.

5.73
-0.36  -6%
Previous Close 6.09
Open 6.09
52 Week Low 5.65
52 Week High 17.82
Market Cap $352,349,441
Shares 61,492,049
Float 28,409,076
Enterprise Value $306,894,361
Volume 94,104
Av. Daily Volume 144,331
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Upcoming Catalysts

Drug Stage Catalyst Date
CNM-ZnAg
COVID-19
Phase 2
Phase 2
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CNM-Au8 (RESCUE-ALS)
Amyotrophic Lateral Sclerosis
Phase 2
Phase 2
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CNM-Au8 (HEALEY ALS Platform Trial)
Amyotrophic Lateral Sclerosis
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
CNM-Au8 (VISIONARY-MS)
Multiple Sclerosis
Phase 2
Phase 2
Phase 2 enrollment to continue through 2021.
CNM-Au8 (REPAIR-MS)
Multiple Sclerosis
Phase 2
Phase 2
Phase 2 trial met primary endpoint - August 5, 2021.
CNM-Au8 (REPAIR-PD)
Parkinson's Disease
Phase 2
Phase 2
Phase 2 trial met primary endpoint - August 5, 2021.

Latest News

  1. SALT LAKE CITY, Sept. 23, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat cellular energetic failure, announced the launch of a second U.S. Food and Drug Administration (FDA) expanded access program (CNMAu8.EAP02) with CNM-Au8 for people living with amyotrophic lateral sclerosis (ALS).

    This expanded access program will be implemented in conjunction with the Healey ALS Platform Trial, a registration trial in which CNM-Au8®, a catalytically-active gold nanocrystal suspension, is currently being evaluated for the treatment…

    SALT LAKE CITY, Sept. 23, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat cellular energetic failure, announced the launch of a second U.S. Food and Drug Administration (FDA) expanded access program (CNMAu8.EAP02) with CNM-Au8 for people living with amyotrophic lateral sclerosis (ALS).

    This expanded access program will be implemented in conjunction with the Healey ALS Platform Trial, a registration trial in which CNM-Au8®, a catalytically-active gold nanocrystal suspension, is currently being evaluated for the treatment of ALS, with topline results expected mid-2022. The Healey ALS Platform trial is led by Dr. Merit Cudkowicz, Director of the Sean M. Healey & AMG Center for ALS, Chief of the Department of Neurology at Massachusetts General Hospital (MGH) and the Julieanne Dorn Professor of Neurology at Harvard Medical School, and her team. The expanded access program is designed to provide people with ALS who are not eligible to enroll in the Healey ALS Platform Trial access to CNM-Au8, an investigational cellular energetic catalyst that supports energy production.

    The Healey Center will support the expanded access program at three participating clinical trial sites in the Healey ALS Platform Trial. CNMAu8.EAP02 will enroll participants across three sites. The first two sites to be included are the Holy Cross Hospital in Fort Lauderdale, Florida and the Hospital for Special Care in New Britain, Connecticut.

    Robert Glanzman, MD, FAAN, Clene's Chief Medical Officer, commented, "We are honored to be collaborating with the Healey Center for ALS in this critically important effort of providing access to CNM-Au8 to people with ALS who may benefit. The Healey Center is an outstanding partner, and we proudly share its goal of developing lifesaving therapies for the treatment of ALS."

    CNMAu8.EAP02 is the second expanded access program with CNM-Au8 that Clene is currently supporting for people with ALS. The initial expanded access program (CNMAu8.EAP01) was also launched in partnership with the Sean M. Healey & AMG Center for ALS at MGH and presently supports access to CNM-Au8 for 40 people living with ALS. CNMAu8.EAP01 started enrolling participants in September 2019 with long-term participants now treated for over 100 weeks.

    "While CNM-Au8 advances through the registration platform trial with an aim to become available to all patients with ALS, expanded access programs enable more people with ALS to benefit today from the potential of our first-in-class neuroreparative energetic nanotherapeutic. Clene is committed to supporting communities living with devastating neurodegenerative diseases, and we are doing our utmost each day to reach and treat more patients," stated Rob Etherington, Clene's President and CEO.

    About Amyotrophic Lateral Sclerosis (ALS)

    ALS is a universally fatal neurodegenerative disorder that results in loss of motor neurons in the cerebral cortex, brain stem, and spinal cord. ALS (also known as Lou Gehrig's disease) leads to the death of the neurons controlling voluntary muscles resulting in weakness, muscle atrophy, and progressive paralysis. ALS affects more than 15,000 patients in the United States and is the most prevalent adult-onset progressive motor neuron disease.

    About the HEALEY-ALS Platform Trial

    The HEALEY ALS Platform Trial is led by a panel of expert amyotrophic lateral sclerosis (ALS) scientists. This breakthrough trial, the first ever platform trial for the treatment of ALS, is designed to reduce trial time, reduce costs and increase patient participation in developing novel therapies for ALS. The trial includes substantial financial support from philanthropic donors and foundations, and presently involves more than 50 expert ALS clinical trial sites across the United States.

    About CNM-Au8®

    Clene's lead drug candidate, CNM-Au8, is an aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals. Resulting from a patented manufacturing breakthrough, the catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions in the brain that enable neurorepair and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 crosses the blood-brain barrier and is not associated with the toxicities related to synthetic gold compounds or nanoparticles manufactured via alternative methods. CNM-Au8 has demonstrated safety in Phase 1 studies in healthy volunteers and has shown both remyelination and neuroprotective effects in multiple preclinical (animal) models. Preclinical data, both published in peer-reviewed journals and presented at scientific congresses, demonstrate that treatment of neuronal cultures with CNM-Au8 improves survival of neurons, protects neurite networks, decreases intracellular levels of reactive oxygen species, and improves mitochondrial capacity in response to cellular stresses induced by numerous disease-relevant neurotoxins. Oral treatment with CNM-Au8 improved functional behaviors in rodent models of ALS, MS, and PD versus vehicle (placebo). CNM-Au8 is a federally registered trademark of Clene Nanomedicine, Inc.

    About Clene

    Clene, a clinical-stage biopharmaceutical company focused on neurodegenerative disease treatments, is leading the way by using nanotechnology to treat energetic failure, which underlies many neurological diseases. Clene has innovated a novel nanotherapeutic platform to create a new class of drugs. Clene's lead drug candidate, CNM-Au8, is an aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals that drive critical cellular energetic metabolism in the central nervous system (CNS). CNM-Au8 increases cellular energy production to accelerate neurorepair and improve neuroprotection. CNM-Au8 is currently being evaluated in a registration enabling trial in amyotrophic lateral sclerosis (ALS), a Phase 2 trial examining disease progression via a novel electrophysiology technique in patients with early ALS, a Phase 2 trial for the treatment of chronic optic neuropathy in patients with stable relapsing multiple sclerosis (MS), and Phase 2 brain target engagement studies in patients with Parkinson's disease (PD) and MS. Clene has also advanced into the clinic an aqueous solution of ionic zinc and silver for anti-viral and anti-microbial uses. The company is based in Salt Lake City, Utah with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter, LinkedIn and Facebook.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Clene's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "might" and "continues," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene's control and could cause actual results to differ materially and adversely from expected results. Factors that may cause such differences include Clene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Clene's ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene's ability to obtain and maintain protection of intellectual property for its technology and drugs; Clene's reliance on third parties to conduct drug development, manufacturing and other services; Clene's limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on Clene's clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled "Risk Factors" in Clene's Annual Report filed on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Clene's subsequent filings with the U.S. Securities and Exchange Commission. Clene undertakes no obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

    Media Contact

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com

    Investor Contact

    Bruce Mackle

    LifeSci Advisors, LLC

    (929) 469-3859

    bmackle@lifesciadvisors.com 

    Source: Clene Inc.



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  2. SALT LAKE CITY, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat energetic failure, today announced a poster presentation titled "Homeostatic Improvement of Brain Bioenergetic Metabolism in Parkinson's Disease: Results From A Phase 2 REPAIR-PD Clinical Trial With CNM-Au8" at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2021 which takes place September 17 – 22, 2021. The poster presentation is available for view here.

    Clene's Phase 2 REPAIR program achieved a statistically significant…

    SALT LAKE CITY, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat energetic failure, today announced a poster presentation titled "Homeostatic Improvement of Brain Bioenergetic Metabolism in Parkinson's Disease: Results From A Phase 2 REPAIR-PD Clinical Trial With CNM-Au8" at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2021 which takes place September 17 – 22, 2021. The poster presentation is available for view here.

    Clene's Phase 2 REPAIR program achieved a statistically significant increase in its primary endpoint, the mean change in brain NAD+/NADH ratio (p=0.037). NAD is an essential molecule responsible for cellular energy production. While the NAD+/NADH ratio declines normally during aging by approximately 0.5% per decade, reduced NAD+/NADH ratios have been reported in multiple neurodegenerative diseases, and the decline in the ratio is implicated in Parkinson's disease. In the REPAIR-PD study, the trend in NAD+/NADH ratio improvement was driven by both increased NAD+ and decreased NADH. Patients were evaluated using an innovative non-invasive brain imaging technique, phosphorous magnetic resonance spectroscopy, before and after 12 or more weeks of daily oral dosing with CNM-Au8. End of treatment results were compared to baseline. Exploratory endpoints revealed that taking CNM-Au8 resulted in the normalization of several critical markers of brain energy production capacity including beta-ATP levels and phosphorylation potential. There were no serious adverse events and treatment-emergent adverse events were mild and transient.

    Robert Glanzman, MD FAAN, Clene's Chief Medical Officer, commented, "We are very pleased to share our results with the Parkinson's treatment community at the MDS Virtual Congress. We see CNM-Au8's impact on brain bioenergetics as a breakthrough in the way Parkinson's will be treated. The 10% increase in the NAD+/NADH ratio seen in our Phase 2 REPAIR Program corresponds to a reversal of approximately 20 decades of normal aging based on an anticipated decline of 0.5% per decade, a significant result."

    Rob Etherington, Clene's Chief Executive Officer, added, "In addition to achieving its primary endpoint, the RESCUE-PD study reinforced our lead candidate CNM-Au8's central nervous system target engagement, as well as its ability to significantly rebalance brain metabolites, both of which have implications across most neurodegenerative diseases."

    Approximately 7 million people are living with Parkinson's disease, the second most common neurogenerative disorder. Only symptomatic treatments are currently available in a market projected to reach $6 billion by 2025.

    The International Parkinson and Movement Disorder Society (MDS) is a professional society of more than 11,000 clinicians, scientists and other healthcare professionals dedicated to improving the care of patients with movement disorders through education and research.

    About REPAIR-PD

    REPAIR-PD, a Phase 2 single-center, active only, sequential group, investigator blinded study assessed the metabolic effects, safety, pharmacokinetics and pharmacodynamics of CNM-Au8 in patients with Parkinson's disease (PD) diagnosed within 3 years of screening. Investigators and participants were blinded to dose. Participants received orally delivered CNM-Au8 daily each morning for 12 weeks. Participants underwent 31P-MRS brain imaging scans to semi-quantitatively measure energetic metabolites at baseline, prior to and after administration of the drug. The objective of this study was to demonstrate target engagement for CNM-Au8 on central nervous system (CNS) biomarkers related to cellular energy metabolism in patients with PD. The study was conducted at the University of Texas Southwestern Medical Center with a team of internationally recognized experts in brain imaging and treatment of disorders of the CNS. Interim results from REPAIR-PD presented at the MSVirtual2020 Meeting and the ACTRIMS Forum 2021 Meeting showed improvements across key CNS bioenergetic metabolites, including total nicotinamide adenine dinucleotide (NAD) levels, NAD+/NADH ratio (primary endpoint), and adenosine triphosphate (ATP) levels (secondary endpoint), indicating a homeostatic effect of CNM-Au8 on brain energetics. For more information see ClinicalTrials.gov Identifier: NCT03815916.

    About CNM-Au8®, a gold nanocrystal suspension

    Clene's lead drug candidate, CNM-Au8, is an aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals. Resulting from a patented manufacturing breakthrough, the catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions in the brain that enable neurorepair and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 crosses the blood-brain barrier and is not associated with the toxicities related to synthetic gold compounds or nanoparticles manufactured via alternative methods. CNM-Au8 has demonstrated safety in Phase 1 studies in healthy volunteers and has shown both remyelination and neuroprotective effects in multiple preclinical (animal) models. Preclinical data, both published in peer-reviewed journals and presented at scientific congresses, demonstrate that treatment of neuronal cultures with CNM-Au8 improves survival of neurons, protects neurite networks, decreases intracellular levels of reactive oxygen species and improves mitochondrial capacity in response to cellular stresses induced by numerous disease-relevant neurotoxins. Oral treatment with CNM-Au8 improved functional behaviors in rodent models of ALS, MS, and PD versus vehicle (placebo). CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.

    About Clene

    Clene, a clinical-stage biopharmaceutical company focused on neurodegenerative disease treatments, is leading the way by using nanotechnology to treat energetic failure, which underlies many neurological diseases. Clene has innovated a novel nanotherapeutic platform to create a new class of drugs. Clene's lead drug candidate, CNM-Au8, is an aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals that drive critical cellular energetic metabolism in the central nervous system (CNS). CNM-Au8 increases cellular energy production to accelerate neurorepair and improve neuroprotection. CNM-Au8 is currently being evaluated in a Phase 3 registration trial in amyotrophic lateral sclerosis (ALS), a Phase 2 trial examining disease progression via a novel electromyography technique in patients with early ALS, a Phase 2 trial for the treatment of chronic optic neuropathy in patients with stable relapsing multiple sclerosis (MS), and Phase 2 brain target engagement studies in patients with Parkinson's disease (PD) and MS. Clene has also advanced into the clinic an aqueous solution of ionic zinc and silver for anti-viral and anti-microbial uses. The company is based in Salt Lake City, Utah with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter, LinkedIn and Facebook.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Clene's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "might" and "continues," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene's control and could cause actual results to differ materially and adversely from expected results. Factors that may cause such differences include Clene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Clene's ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene's ability to obtain and maintain protection of intellectual property for its technology and drugs; Clene's reliance on third parties to conduct drug development, manufacturing and other services; Clene's limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on Clene's clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled "Risk Factors" in Clene's Annual Report filed on Form 10K, as well as discussions of potential risks, uncertainties, and other important factors in Clene's subsequent filings with the U.S. Securities and Exchange Commission. Clene undertakes no obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

    Media Contact

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com

    Investor Contact

    Bruce Mackle

    LifeSci Advisors, LLC

    (929) 469-3859

    bmackle@lifesciadvisors.com

    Source: Clene Inc.



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    • Final patient visit has been completed in its Phase 2 RESCUE-ALS study; study close-out activities have commenced
    • 90% of eligible patients are continuing to be treated under a long-term open label extension
    • Interim blinded efficacy data after 9-months of treatment with CNN-Au8®, a catalytically-active gold nanocrystal suspension, showed absolute improvement from baseline in neurophysiology endpoints as compared to progressive worsening seen in published data sets

    SALT LAKE CITY, Sept. 09, 2021 (GLOBE NEWSWIRE) --  Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology…

    • Final patient visit has been completed in its Phase 2 RESCUE-ALS study; study close-out activities have commenced
    • 90% of eligible patients are continuing to be treated under a long-term open label extension
    • Interim blinded efficacy data after 9-months of treatment with CNN-Au8®, a catalytically-active gold nanocrystal suspension, showed absolute improvement from baseline in neurophysiology endpoints as compared to progressive worsening seen in published data sets

    SALT LAKE CITY, Sept. 09, 2021 (GLOBE NEWSWIRE) --  Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat cellular energetic failure, announced the final patient visit has been completed in its Phase 2 RESCUE-ALS study and that trial close-out activities have begun. RESCUE-ALS investigated the efficacy, safety, pharmacokinetics and pharmacodynamics of Clene's lead drug candidate, CNM-Au8®, a catalytically-active gold nanocrystal suspension, in patients with early amyotrophic lateral sclerosis (ALS). The trial enrolled a total of 45 patients with ALS, with unblinded topline data expected in Q4 2021.

    90% of eligible patients from the double-blind study elected to roll over into active treatment with 30mg CNM-Au8 under a long-term open label extension (OLE) of the study. The OLE is intended to offer treatment to those originally randomized to placebo in the double-blind, treatment period and to collect longer term efficacy and safety data.

    "Thus far the blinded interim data we have seen on the primary and secondary endpoints of our RESCUE-ALS study are very encouraging. We look forward to the unblinded topline readout before the end of the year. We are grateful to the patients and their families for participating in this important study and are hopeful that those who continue to be treated under the open label extension may continue to benefit from CNM-Au8," stated Robert Glanzman, MD, FAAN, Chief Medical Officer of Clene.

    "Our clinical trial teams in Sydney are very pleased to have reached this important landmark for RESCUE-ALS. It is a tribute to the ALS patients involved in the trial that we were able to recruit for the trial throughout the COVID-19 pandemic. ALS patients have shown great resilience and a willingness to contribute to research and discovery. Now, like them, we look forward to the trial analysis and outcomes," said Professor Matthew Kiernan, AM MBBS(Hons), PhD, DSc, FRACP, FAHMS, Bushell Chair of Neurology, University of Sydney.

    Interim blinded efficacy results from the Phase 2 RESCUE-ALS study were presented at the ENCALS 2021 Annual Meeting on May 12, 2021. The study's primary endpoint, the Motor Unit Number Index (MUNIX), a sensitive predictor of clinical decline in ALS, showed absolute improvements from baseline for approximately 18% of the study population, as compared to the expected continuous decline seen in published data from prior observational studies1. Less loss in forced vital capacity (FVC) was also evident as compared to published data sets2.

    About RESCUE-ALS

    RESCUE-ALS is a Phase 2 multi-center, randomized, double-blind, parallel-group, placebo-controlled study examining the efficacy, safety, pharmacokinetics and pharmacodynamics of CNM-Au8 in patients with early amyotrophic lateral sclerosis (ALS). The trial completed enrollment in 2H 2020. 45 subjects were randomized 1:1 to receive either active treatment with CNM-Au8 (30 mg) or placebo in addition to their current standard of care over a 36-week treatment period. The objective of the study is to assess the impact of improving cellular energy production, reducing oxidative stress, and enhancing energetic homeostasis with CNM-Au8 on disease progression in patients with early-stage ALS. CNM-Au8 was selected by FightMND of Australia and Clene was provided a substantial grant to investigate efficacy in ALS utilizing novel neurophysiological endpoints at two expert clinical sites in Australia. Topline data are expected in Q4 2021. For more information, please see ClinicalTrials.gov Identifier: NCT04098406.

    About CNM-Au8®

    Clene's lead drug candidate, CNM-Au8, is an aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals. Resulting from a patented manufacturing breakthrough, the catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions in the brain that enable neurorepair and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 crosses the blood-brain barrier and is not associated with the toxicities related to synthetic gold compounds or nanoparticles manufactured via alternative methods. CNM-Au8 has demonstrated safety in Phase 1 studies in healthy volunteers and has shown both remyelination and neuroprotective effects in multiple preclinical (animal) models. Preclinical data, both published in peer-reviewed journals and presented at scientific congresses, demonstrate that treatment of neuronal cultures with CNM-Au8 improves survival of neurons, protects neurite networks, decreases intracellular levels of reactive oxygen species and improves mitochondrial capacity in response to cellular stresses induced by numerous disease-relevant neurotoxins. Oral treatment with CNM-Au8 improved functional behaviors in rodent models of ALS, MS, and PD versus vehicle (placebo). CNM-Au8 is a federally registered trademark of Clene Nanomedicine, Inc.

    About Clene

    Clene, a clinical-stage biopharmaceutical company focused on neurodegenerative disease treatments, is leading the way by using nanotechnology to treat energetic failure, which underlies many neurological diseases. Clene has innovated a novel nanotherapeutic platform to create a new class of drugs. Clene's lead drug candidate, CNM-Au8, is an aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals that drive critical cellular energetic metabolism in the central nervous system (CNS). CNM-Au8 increases cellular energy production to accelerate neurorepair and improve neuroprotection. CNM-Au8 is currently being evaluated in a Phase 3 registration trial in amyotrophic lateral sclerosis (ALS), a Phase 2 trial examining disease progression via a novel electromyography technique in patients with early ALS, a Phase 2 trial for the treatment of chronic optic neuropathy in patients with stable relapsing multiple sclerosis (MS), and Phase 2 brain target engagement studies in patients with Parkinson's disease (PD) and MS. Clene has also advanced into the clinic an aqueous solution of ionic zinc and silver for anti-viral and anti-microbial uses. The company is based in Salt Lake City, Utah with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter, LinkedIn and Facebook.

    About FightMND

    FightMND is a not-for-profit registered charity, founded in 2014. It was established to raise the awareness of Motor Neurone Disease (MND) in Australia, to increase funding for research to find an effective treatment and cure and to provide care equipment for MND patients. FightMND have a clear objective – to have a world free from MND.  

    FightMND is Australia's largest independent MND foundation focused on funding large- scale, collaborative research and clinical trials. The generous donations contributed by everyday Australians, right across the country, has enabled FightMND to raise and commit millions to cure and care initiatives.

    References

    1 Neuwirth et al. J Neurol Neurosurg Psychiatry. 2015 Nov;86(11):1172-9.

    2 Andrews et al. JAMA Neurol. 2018 Jan 1;75(1):58-64.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Clene's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "might" and "continues," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene's control and could cause actual results to differ materially and adversely from expected results. Factors that may cause such differences include Clene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Clene's ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene's ability to obtain and maintain protection of intellectual property for its technology and drugs; Clene's reliance on third parties to conduct drug development, manufacturing and other services; Clene's limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on Clene's clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled "Risk Factors" in Clene's Annual Report filed on Form 10K, as well as discussions of potential risks, uncertainties, and other important factors in Clene's subsequent filings with the U.S. Securities and Exchange Commission. Clene undertakes no obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

    Media Contact

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com

    Investor Contact

    Bruce Mackle

    LifeSci Advisors, LLC

    (929) 469-3859

    bmackle@lifesciadvisors.com 

    Source: Clene Inc.

     



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  3. SALT LAKE CITY, Aug. 31, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat energetic failure, today announced that the Company will present at the following investor conferences in September:

    Citi's 16th Annual BioPharma Virtual Conference
    Date: September 8-10, 2021
    Format: 1x1 meetings

    H.C. Wainwright 23rd Annual Global Investment Conference
    Date: September 13, 2021
    Time: 7:00 a.m. ET
    Format: Corporate Presentation (pre-recorded), and 1x1 meetings

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
    Date: September…

    SALT LAKE CITY, Aug. 31, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat energetic failure, today announced that the Company will present at the following investor conferences in September:

    Citi's 16th Annual BioPharma Virtual Conference

    Date: September 8-10, 2021

    Format: 1x1 meetings

    H.C. Wainwright 23rd Annual Global Investment Conference

    Date: September 13, 2021

    Time: 7:00 a.m. ET

    Format: Corporate Presentation (pre-recorded), and 1x1 meetings

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date: September 21, 2021

    Time: 2:05 p.m. ET

    Format: Corporate Presentation (live), and 1x1 meetings

    2021 Cantor Virtual Global Healthcare Conference

    Date: September 27, 2021

    Time: 2:00 p.m. ET

    Format: Corporate Presentation (live), and 1x1 meetings

    Webcasts of the presentations will be available on the "Events and Presentations" section of the Clene website.

    About Clene

    Clene, a clinical-stage biopharmaceutical company focused on neurodegenerative disease treatments, is leading the way by using nanotechnology to treat energetic failure, which underlies many neurological diseases. Clene has innovated a novel nanotherapeutic platform to create a new class of drugs. Clene's lead drug candidate, CNM-Au8®, is an aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals that drive critical cellular energetic metabolism in the central nervous system (CNS). CNM-Au8 increases cellular energy production to accelerate neurorepair and improve neuroprotection. CNM-Au8 is currently being evaluated in a Phase 3 registration trial in amyotrophic lateral sclerosis (ALS), a Phase 2 trial examining disease progression via a novel electromyography technique in patients with early ALS, a Phase 2 trial for the treatment of chronic optic neuropathy in patients with stable relapsing multiple sclerosis (MS), and Phase 2 brain target engagement studies in patients with Parkinson's disease (PD) and MS. Clene has also advanced into the clinic an aqueous solution of ionic zinc and silver for anti-viral and anti-microbial uses. The company is based in Salt Lake City, Utah with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter, LinkedIn and Facebook.

    CNM-Au8®, a gold nanocrystal suspension, is a federally registered trademark of Clene Nanomedicine, Inc.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Clene's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "might" and "continues," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene's control and could cause actual results to differ materially and adversely from expected results. Factors that may cause such differences include Clene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Clene's ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene's ability to obtain and maintain protection of intellectual property for its technology and drugs; Clene's reliance on third parties to conduct drug development, manufacturing and other services; Clene's limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on Clene's clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled "Risk Factors" in Clene's Annual Report filed on Form 10K, as well as discussions of potential risks, uncertainties, and other important factors in Clene's subsequent filings with the U.S. Securities and Exchange Commission. Clene undertakes no obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

    Media Contact

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com

    Investor Contact

    Bruce Mackle

    LifeSci Advisors, LLC

    (929) 469-3859

    bmackle@lifesciadvisors.com

    Source: Clene Inc.



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  4. SALT LAKE CITY, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat energetic failure, today announced the completion of two lease agreements that will more than quadruple the company's manufacturing capacity for its lead asset, CNM-Au8®, a gold nanocrystal suspension.

    The first of these agreements is a ten (10) year lease for a manufacturing space located at 100 Chesapeake Boulevard, Elkton, Maryland. The 74,210 sq. ft. building will be redeveloped to support Clene's proprietary electrochemical processes for manufacturing…

    SALT LAKE CITY, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat energetic failure, today announced the completion of two lease agreements that will more than quadruple the company's manufacturing capacity for its lead asset, CNM-Au8®, a gold nanocrystal suspension.

    The first of these agreements is a ten (10) year lease for a manufacturing space located at 100 Chesapeake Boulevard, Elkton, Maryland. The 74,210 sq. ft. building will be redeveloped to support Clene's proprietary electrochemical processes for manufacturing CNM-Au8 and will materially increase its manufacturing capacity in advance of the expected H1 2022 data release from its Phase 3 registration trial evaluating CNM-Au8 as a treatment for amyotrophic lateral sclerosis (ALS). Clene expects redevelopment to commence within weeks and plans on partial occupancy with a few months and Phase 1 of production to be underway in the first half of 2022.

    Simultaneously, Clene entered into a seven (7) year lease to further expand its existing manufacturing capacity at its site located at 500 Principio Parkway West, North East, Maryland to a total of 32,229 sq. ft. This expansion enables additional R&D and manufacturing capacity for CNM-Au8 and further positions Clene to address its potential long-term needs in its efforts to treat the neurodegenerative diseases of ALS, multiple sclerosis and Parkinson's disease.

    Rob Etherington, Chief Executive Officer and President of Clene commented, "All emerging pharmaceutical companies face the delicate balance of striving to align manufacturing capacity with the rigors of regulatory approvals and ultimately patient needs. As we move towards a readout from our registration trial in patients with ALS, we concluded this was the most appropriate time to undertake this expansion of our manufacturing capabilities. This will help enable that we are well prepared to meet the urgent unmet needs of ALS patients should CNM-Au8 receive regulatory approval."

    Mr. Etherington continued, "Clene is greatly appreciative of all the efforts behind the scenes by many parties to help facilitate this critical step in Clene's evolution in an expeditious and efficient manner. We would like to thank them for helping us advance towards our goal of transforming the treatment of neurodegenerative disease."

    Mark Mortenson, Chief Science Officer of Clene commented, "Completion of these lease agreements could not have been accomplished without the tireless work of our landlord, the Town of Elkton, Cecil County and the State of Maryland. The foresight, professionalism and commitment by the leadership teams in the town, the county and the state were wonderful to experience and are a perfect example of the teamwork that abounds in the State of Maryland."

    On July 27, 2021, Governor Larry Hogan and Commerce Secretary Kelly Schulz visited Clene's current manufacturing site and joined a helicopter ride to view Clene's new Elkton, Maryland manufacturing site from the air.

    About Clene

    Clene, a clinical-stage biopharmaceutical company focused on neurodegenerative disease treatments, is leading the way by using nanotechnology to treat energetic failure, which underlies many neurological diseases. Clene has innovated a novel nanotherapeutic platform to create a new class of drugs. Clene's lead drug candidate, CNM-Au8, is an aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals that drive critical cellular energetic metabolism in the central nervous system (CNS). CNM-Au8 increases cellular energy production to accelerate neurorepair and improve neuroprotection. CNM-Au8 is currently being evaluated in a Phase 3 registration trial in amyotrophic lateral sclerosis (ALS), a Phase 2 trial examining disease progression via a novel electromyography technique in patients with early ALS, a Phase 2 trial for the treatment of chronic optic neuropathy in patients with stable relapsing multiple sclerosis (MS), and Phase 2 brain target engagement studies in patients with Parkinson's disease (PD) and MS. Clene has also advanced into the clinic an aqueous solution of ionic zinc and silver for anti-viral and anti-microbial uses. The company is based in Salt Lake City, Utah with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter, LinkedIn and Facebook.

    CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Clene's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "might" and "continues," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene's control and could cause actual results to differ materially and adversely from expected results. Factors that may cause such differences include Clene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; any unanticipated delays and expenses encountered in connection with the expansion of Clene's manufacturing capacity, including any due to regulatory requirements; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Clene's ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene's ability to obtain and maintain protection of intellectual property for its technology and drugs; Clene's reliance on third parties to conduct drug development, manufacturing and other services; Clene's limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on Clene's clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled "Risk Factors" in Clene's Annual Report filed on Form 10K, as well as discussions of potential risks, uncertainties, and other important factors in Clene's subsequent filings with the U.S. Securities and Exchange Commission. Clene undertakes no obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

    Media Contact

    Gwendolyn Schanker

    LifeSci Communications

    (269) 921-3607

    gschanker@lifescicomms.com

    Investor Contact

    Bruce Mackle

    LifeSci Advisors, LLC

    (929) 469-3859

    bmackle@lifesciadvisors.com

    Source: Clene Inc.



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