GlobeNewswire Inc | Dec 15, 2021 07:00AM EST

December 15, 2021

Powerful combination of key patents comes as the Company looks ahead to topline results from a Phase 3 registration study in ALS in second half of 2022

SALT LAKE CITY, Dec. 15, 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 focused on revolutionizing the treatment of neurodegenerative disease, announced it has validated key patents granted by the European Patent Office that protect the Companys breakthrough processes, devices and methods for treating certain disease indications for its nanotherapeutic drugs.

A broad, foundational patent granted in Europe titled Continuous Methods for Treating Liquids and Manufacturing Certain Constituents (e.g., Nanoparticles) in Liquids, Apparatuses and Nanoparticles and Nanoparticle/Liquid Solution(s) Resulting Therefrom affords critical patent protection for Clene in the worlds largest healthcare markets as the Company expects topline results from a Phase 3 registration study of its lead drug candidate, CNM-Au8, a gold nanocrystal suspension, for the treatment of amyotrophic lateral sclerosis (ALS). The patent covers a broad set of process and device claims pertaining to Clenes platform electrochemical technology for making aqueous solutions and suspensions of metallic ions and/or nanocrystals.

The second patent granted by the European Patent Office titled Methods and Treatment for Certain Demyelination-Based Disorders and/or Promoting Remyelination addresses the use of gold nanosuspensions for the treatment of certain diseases.

Clenes technology, which is at the intersection of physics and biology, is potentially the first to effectively address cellular energetic failure, the root cause of many neurological diseases, said Rob Etherington, Clenes President and CEO. Our revolutionary approach to improve energy production to promote neuroprotection and remyelination is protected by our expanding patent estate across major global markets. These two most recently granted patents in Europe provide broad protection, ranging from methods of manufacturing and novel devices used for manufacturing, as well as methods for treating certain disease indications.

About CNM-Au8, a gold nanocrystal suspensionClenes lead drug candidate, CNM-Au8, a catalytically active gold nanotherapeutic, is the result of a patented manufacturing breakthrough. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions in the brain that enable neuroprotection 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 is being evaluated in a Phase 3 registration trial for the treatment of amyotrophic lateral sclerosis (ALS). In the REPAIR Program Phase 2 open-label biomarker clinical trials, CNM-Au8 demonstrated target engagement in the treatment of Parkinsons disease (PD) and multiple sclerosis (MS). REPAIR-PD has concluded, and REPAIR-MS will continue with the initiation of a second MS dosing cohort. 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 CleneClene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease with potential first-in-class nanotherapeutics to treat energetic failure, an underlying cause of many neurological diseases. Our lead drug candidate, CNM-Au8, is an oral suspension of gold nanocrystals that drive critical cellular energetic metabolism in the central nervous system (CNS). CNM-Au8 increases energy production and utilization to accelerate neurorepair and improve neuroprotection. CNM-Au8 is currently being evaluated in a Phase 3 registration trial in amyotrophic lateral sclerosis (ALS) and a Phase 2 trial for the treatment of chronic optic neuropathy in patients with stable relapsing multiple sclerosis (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 StatementsThis press release contains forward-looking statements which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Clenes 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 Clenes control and could cause actual results to differ materially and adversely from expected results. Factors that may cause such differences include Clenes 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; Clenes ability to achieve commercial success for its marketed products and drug candidates, if approved; Clenes ability to obtain and maintain protection of intellectual property for its technology and drugs; Clenes reliance on third parties to conduct drug development, manufacturing and other services; Clenes 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 Clenes clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled Risk Factors in Clenes Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Clenes 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 ContactMaggie BellerRusso Partners, LLCMaggie.Beller@RussoPartnersLLC.com+1-646-942-5631

Investor ContactJohn WoolfordManaging Director, Westwickeclene@westwicke.com+1-443-213-0506