• Clene’s presentation by CEO Rob Etherington and CFO Morgan Brown is now available on demand on the event’s website, covering the company’s recent achievements and immediate plans for lead drug candidate CNM-Au8^®.
• Clene is planning to submit a New Drug Application (“NDA”) to the FDA for potential accelerated approval for CNM-Au8 for ALS in the second half of 2025.
• The company recently released the latest data from a cross-regimen analysis of HEALEY ALS Platform Trial, showing that CNM-Au8 significantly extends survival in patients with ALS.

Clene (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”), announced that its presentation for the Q1 Virtual Investor Summit has been made available for on-demand viewing on the event’s website (https://ibn.fm/xPuSL).

Any summit attendees and investors who missed the live presentations can now access the panels at their convenience, while those who wish to revisit key moments and insights can easily do so by checking the recorded talks. Clene’s presentation can be accessed at https://ibn.fm/cqvHy.

The March 11th Q1 Virtual Investor Summit was an exclusive event for investors who specialize in small and microcap stocks, presenting them with the unique opportunity to be introduced to 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 focused on microcap companies that are undervalued. The event featured a diverse lineup of microcap companies showcasing their latest developments, growth plans, and market strategies.

Clene’s presentation, given by CEO, Rob Etherington and CFO, Morgan Brown, focused on the company’s latest achievements and the next steps for lead drug candidate CNM-Au8. 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 company is currently planning to submit an NDA to the U.S. Food and Drug Administration (“FDA”) in the second half of 2025 to secure potential accelerated approval for CNM-Au8 for ALS. The drug candidate has a robust safety profile and has yielded positive results in two independent clinical trials to date. In these two Phase 2 clinical trials, the RESCUE-ALS and HEALEY ALS Platform Trials, participants who were administered CNM-Au8 saw significant improvement in survival rates, functional status and combined assessment of function and survival.

The lead drug candidate’s improved survival rates were also confirmed by recently released new data derived from a cross-regimen post hoc analysis of long-term survival in HEALEY ALS Platform Trial participants. The treatment was confirmed to improve survival in ALS patients by up to 14.8 months, with the strongest survival benefit observed in patients meeting the planned criteria for Clene’s upcoming Phase 3 RESTORE-ALS trial.

The company is planning to launch the confirmatory Phase 3 RESTORE-ALS trial in mid-2025, while also considering an accelerated approval pathway for CNM-Au8, following discussions with the FDA in late 2024. As part of this process, Clene will conduct additional biomarker analyses, focusing on neurofilament light chain (“NfL”) data—an important measure of ALS progression.

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. The company is pursuing the accelerated approval pathway for CNM-Au8 to offer hope and help obtain the best outcome for people living with ALS.

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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