Clene Inc. (NASDAQ: CLNN) Announces Four-Year Grant to Support Expanded Access Protocol for CNM-Au8 From NINDS

• Clene’s wholly-owned subsidiary, Clene Nanomedicine Inc., in collaboration with Columbia University and Synapticure, has been awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (“NINDS”)
• The study will monitor safety, survival, clinical worsening, and key disease progression-related biomarkers while using CNM-Au8
• Research conducted by Clene estimates that ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the US and an estimated 500,000 people worldwide, with a life expectancy of diagnosed patients typically ranging from three to five years

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company on a mission to transform the treatment of neurodegenerative diseases, recently announced that its wholly-owned subsidiary Clene Nanomedicine Inc., in collaboration with Columbia University and Synapticure, has been awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (“NINDS”). The grant will support an Expanded Access Protocol (“EAP”) for Clene’s investigational drug, CNM-Au8(R), for amyotrophic lateral sclerosis (“ALS”). The grant is supported by the National Institute of Health (“NIH”) grant U01NS136023 (https://ibn.fm/03fnZ).

An EAP, also called “Compassionate Use,” is an FDA-regulated pathway that allows people with serious and life-threatening diseases to access investigational drugs that have not yet been approved by the US Food and Drug Administration (“FDA”). In addition to the EAP, Clene plans to continue its current ongoing ALS EAP programs, which have enrolled more than 200 participants since 2019.

Jinsy A. Andrews, MD, MSc, FAAN, an associate professor of neurology in the Division of Neuromuscular Medicine and director of Neuromuscular Clinical Trials at Columbia University, said this EAP study will give ALS patients who don’t meet the criteria to enroll in a clinical trial an opportunity to try CNM-Au8 as a novel investigational therapy through this EAP program. “Programs like this help to advance research and much-needed innovation in ALS,” he added.

In addition to Andrews, the EAP study will be led by Eric Anderson, MD, PhD, MBA, FAAN, of Synapticure, and Benjamin Greenberg, MD, MHS, FAAN, Head of Medical of Clene. The EAP will provide eligible people living with ALS to work with clinicians to access CNM-Au8 – with access available across all 50 states, including remote and rural areas, through Synapticure’s telemedicine neurology clinic and nationwide clinics. The study will monitor safety, survival, clinical worsening, and key disease progression-related biomarkers while using CNM-Au8.

“Clene has demonstrated evidence of consistent safety and improved survival for CNM-Au8 across a broad ALS population in two independent Phase 2 trials and an ongoing EAP with up to 3.8 years of follow-up,” Greenberg stated. “This new EAP provides access to CNM-Au8 for more people living with ALS and enables the collection of survival, safety, and biomarker data in a population not studied in clinical trials. These data can help provide confirmatory support for the existing trial data Clene has gathered in its clinical trials.”

According to research conducted by Clene, ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the US and an estimated 500,000 people worldwide. The life expectancy of diagnosed patients typically ranges from three to five years – with a high market need for treatments that affect daily function and survival. Coupled with a critical unmet need for therapeutic interventions, the EAP will provide additional support to people with ALS who did not have access to these types of drugs in the past.

“We are truly excited to be a part of this grant with Clene and Columbia and to support people living with ALS by providing access to treatments that could meaningfully impact the course of their disease,” Anderson said. “We are grateful to NINDS for recognizing how a virtual platform like Synapticure can provide expanded access programs in a remote capacity. It will allow us to reach people living with ALS across the US who have not previously had access to investigational medicines, like CNM-Au8.”

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://ibn.fm/CLNN

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