Core Insights - Clene, Inc. and its subsidiary Clene Nanomedicine, Inc. reported new evidence of remyelination and neuronal repair in multiple sclerosis (MS) patients following treatment with CNM-Au8® 30 mg, as analyzed in the long-term open-label extension of the VISIONARY-MS Trial [1][4][6] Group 1: Clinical Findings - The VISIONARY-MS Trial demonstrated significant improvements in cognition and visual function among MS participants treated with CNM-Au8, supported by objective biomarkers such as advanced MRI Diffusion Tensor Imaging (DTI) and multi-focal Visual Evoked Potential (mf-VEP) assessments [2][3] - Improvements in low contrast letter acuity (LCLA) and symbol digit modality test (SDMT) were observed in CNM-Au8 participants, marking a notable advancement compared to other repair candidate drugs in MS clinical trials [3][5] - Over 90% of participants showing cognitive and visual improvements also exhibited corresponding enhancements in MRI and visual electrophysiology tests [6] Group 2: Biomarker Correlation - MRI DTI metrics, including Axial Diffusivity (AD) and Magnetization Transfer Ratio (MTR), confirmed structural improvements in the neuronal architecture of MS patients treated with CNM-Au8, indicating remyelination and repair [7] - 96% of LCLA responders demonstrated improvements in MRI DTI metrics, while 91% of visual responders exhibited enhancements in mf-VEP metrics, further supporting the link between visual and cognitive recovery and neuronal repair [8] - 98% of SDMT responders with improved cognition had corresponding improvements in MRI DTI metrics, substantiating the association between cognitive enhancement and neuronal repair [8] Group 3: Company Overview - Clene, Inc. is a late clinical-stage biopharmaceutical company focused on therapies for neurodegenerative diseases, including ALS and MS, with CNM-Au8 being a first-in-class investigational therapy targeting mitochondrial function and reducing oxidative stress [9][10]

About Clene Clene Inc. (NASDAQ:CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary, Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson's disease, and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system cells' survival and function via a mec ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission file number: 01-39834 CLENE INC. (Exact name of registrant as specified in its charter) Delaware 85-2828339 (State or other jur ...

Clene Inc. (CLNN) came out with a quarterly loss of $1.67 per share versus the Zacks Consensus Estimate of a loss of $1.21. This compares to loss of $1.20 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -38.02%. A quarter ago, it was expected that this company would post a loss of $1.34 per share when it actually produced a loss of $1.22, delivering a surprise of 8.96%.Over the last four quarters, the company has surpassed con ...

Financial Performance - Clene reported a net loss of $39.4 million, or $5.67 per share, for the year ended December 31, 2024, compared to a net loss of $49.5 million, or $9.43 per share, for the same period in 2023[13]. - Total revenue for 2024 was $342,000, a decrease of 47.7% compared to $654,000 in 2023[20]. - Product revenue decreased to $237,000 in 2024 from $498,000 in 2023, representing a decline of 52.5%[20]. - Comprehensive loss for 2024 was $39,528,000, compared to $49,508,000 in 2023, indicating a reduction of 20.2%[20]. - Net loss for 2024 was $39,400,000, an improvement of 20.4% compared to a net loss of $49,504,000 in 2023[20]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $12.2 million as of December 31, 2024, down from $35.0 million as of December 31, 2023[9]. - Cash and cash equivalents decreased to $12,155,000 in 2024 from $28,821,000 in 2023, a decline of 57.8%[21]. - Total assets decreased to $27,337,000 in 2024 from $52,341,000 in 2023, a reduction of 47.9%[21]. - Total liabilities decreased slightly to $36,194,000 in 2024 from $38,951,000 in 2023[21]. - Additional paid-in capital increased to $273,194,000 in 2024 from $255,913,000 in 2023, reflecting a growth of 6.7%[21]. Research and Development - Research and development expenses were $20.1 million for the year ended December 31, 2024, compared to $26.7 million for the same period in 2023, reflecting a decrease primarily due to lower expenses related to ongoing clinical trials[10]. - Research and development expenses were $20,058,000 in 2024, down 24.5% from $26,655,000 in 2023[20]. - Clene is collecting and analyzing biomarker NfL data from its NIH-sponsored Early Access Protocol (EAP) for evaluation in the third quarter of 2025[5]. Clinical Trials and Regulatory Updates - Clene plans to submit a New Drug Application (NDA) in the second half of 2025 for potential Accelerated Approval of CNM-Au8 in ALS[5]. - Clene intends to initiate the confirmatory Phase 3 RESTORE-ALS trial in mid-2025, designed to investigate the effects of CNM-Au8 on improved survival and delayed time to ALS clinical worsening events[7]. - The FDA provided guidance on a potential path to meet the regulatory standard for substantial evidence of effectiveness supporting accelerated approval for CNM-Au8 in ALS[6]. - Overall Survival Improvement of 4.1 months was observed in participants treated with CNM-Au8 compared to a control group in the HEALEY ALS Platform Trial[6]. General and Administrative Expenses - General and administrative expenses decreased to $13.3 million for the year ended December 31, 2024, from $14.4 million for the same period in 2023[11]. Debt and Financing - Clene secured a new $10.0 million debt facility at a lower interest rate to replace the remaining outstanding $7.85 million debt balance with Avenue Capital[5]. - The weighted average common shares used to compute basic and diluted net loss per share increased to 6,954,133 in 2024 from 5,246,941 in 2023[20].

Core Insights - Clene Inc. reported its full year 2024 financial results and highlighted its ongoing clinical programs for neurodegenerative diseases, particularly ALS and MS [1][2][3] Financial Performance - Clene's cash, cash equivalents, and marketable securities totaled $12.2 million as of December 31, 2024, down from $35.0 million as of December 31, 2023 [8] - The company reported a net loss of $39.4 million, or $5.67 per share, for the year ended December 31, 2024, compared to a net loss of $49.5 million, or $9.43 per share, for the same period in 2023 [12] - Research and development expenses were $20.1 million for 2024, a decrease from $26.7 million in 2023, primarily due to lower expenses related to ongoing clinical trials [9] Clinical Development - Clene plans to submit a New Drug Application (NDA) in the second half of 2025 for potential Accelerated Approval of CNM-Au8 for ALS [4][5] - The company is set to initiate the confirmatory Phase 3 RESTORE-ALS trial in mid-2025, which aims to evaluate the effects of CNM-Au8 on survival and clinical worsening events in ALS patients [6][17] - Clene is collecting and analyzing neurofilament light chain (NfL) biomarker data from its NIH-sponsored Early Access Protocol (EAP) to support its NDA submission [4][5] Regulatory Engagement - Clene received written guidance from the FDA regarding a potential accelerated approval pathway for CNM-Au8 in ALS [3] - The company plans to meet with the FDA in the second quarter of 2025 to align on its statistical analysis plan for the NfL biomarker data [2][5] Debt and Financing - Clene secured a new $10.0 million debt facility to replace its outstanding $7.85 million debt balance, with a fixed interest rate of 12% [7] - The new debt facility is partially convertible into shares of Clene's common stock at a fixed conversion price of $5.67, representing a 30% premium to the stock price at signing [7] Market Position - Clene is focused on revolutionizing the treatment of neurodegenerative diseases, including ALS and MS, through its investigational therapy CNM-Au8, which targets mitochondrial function and reduces oxidative stress [13][15]

Core Insights - Clene, Inc. and its subsidiary Clene Nanomedicine, Inc. announced significant survival benefits from their treatment CNM-Au8® for ALS patients based on new analyses from the HEALEY ALS Platform Trial [1][5] Group 1: Survival Analysis Results - The analysis compared survival rates between participants receiving CNM-Au8 30 mg and those in Regimen A, with a follow-up period of up to 48 months [2] - The CNM-Au8 30 mg group achieved a median survival of 951 days compared to 753 days in the Regimen A group, resulting in a gain of 198 days (6.5 months) [6] - A covariate-adjusted RMST improvement of 124 days (4.1 months) was observed, with statistical significance (p=0.045) [6] Group 2: Enhanced Benefits in Specific Patient Subsets - In participants with baseline serum neurofilament light (NfL) levels > 33 pg/mL, median survival improved from 589 days (Regimen A) to 951 days (CNM-Au8), representing an 11.9 month gain [6] - This group experienced a 44% reduction in mortality risk (Cox HR: 0.556, p=0.006) and an RMST improvement of 197 days (6.5 months) [6] - Among participants meeting the core RESTORE-ALS Trial criteria, median survival improved from 628 days (Regimen A) to 1079 days (CNM-Au8), an increase of 451 days (14.8 months) [6] Group 3: Future Clinical Trials and Strategic Direction - Clene plans to launch the Phase 3 RESTORE-ALS study in mid-2025, which will serve as a confirmatory trial for FDA approval [5][11] - The company aims to discuss these findings with the FDA as part of their commercialization strategy [5]

Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on treating neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS) [1][3] - The company aims to improve mitochondrial health and protect neuronal function through its investigational therapy CNM-Au8, which targets mitochondrial function and the NAD pathway while reducing oxidative stress [3] Upcoming Events - Clene management will participate in a fireside chat at the 37th Annual Roth Conference on March 18, 2025, at 9:20 am PST [2] - The event will be conducted in a virtual format, and 1x1 investor meetings will also be hosted [2] Research and Development - Clene's research and development operations are based in Maryland, while the company is headquartered in Salt Lake City, Utah [3]

Core Insights - Clene Inc. has entered into an agreement with APST Research GmbH to utilize its NfL database for FDA-recommended analyses of CNM-Au8's effect on neurofilament light chain (NfL) decline in ALS patients [1][4][6] Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on treating neurodegenerative diseases, including ALS and MS, through its investigational therapy CNM-Au8 [7][8] - CNM-Au8 is designed to improve mitochondrial health and neuronal function, targeting oxidative stress and enhancing energy production [8][11] Collaboration with APST Research - APST Research maintains a comprehensive ALS database, including data from over 4,300 ALS patients, which will support Clene's analysis of NfL changes [2][3] - The collaboration aims to provide a robust statistical analysis plan for NfL evaluations in NIH-sponsored Expanded Access Protocols (EAPs) [2][4] Clinical Data and Analysis - Clene's analysis will include data from more than 1,625 ALS patients, correlating NfL biomarker data with clinical assessments and events [3][4] - The objective is to demonstrate that NfL change rates are associated with survival in ALS patients, potentially supporting the NDA submission for CNM-Au8 [3][4] Real-World Evidence Collection - Clene has treated nearly 500 ALS patients through its EAP programs to gather Real-World Evidence (RWE) on CNM-Au8's effects [4][5] - Positive results from the NfL reduction analysis could support the planned New Drug Application (NDA) for CNM-Au8, expected in the second half of 2025 [4][6] Safety Profile - Over 800 participant years of treatment with CNM-Au8 have not revealed significant safety concerns or serious adverse events related to the treatment [5]

Core Viewpoint - Clene Inc. has secured a new $10 million debt facility to replace the remaining $7.85 million of Avenue Capital debt, which will enhance its cash position and support the new drug application for CNM-Au8 for ALS through an accelerated regulatory pathway [1][4] Group 1: Debt Facility Details - The new debt facility is a secured, partially convertible Note with a principal amount of $10 million, a maturity of eighteen months, and a fixed interest rate of 12% [2] - The first twelve months of the Note will be interest-only, and 65% of the Note is convertible into shares of Clene's common stock at a fixed conversion price of $5.67, representing a 130% premium to Clene's closing stock price on the signing day [2] Group 2: Previous Loan Agreement - In May 2021, Clene entered into a Loan and Security Agreement with Avenue Venture Opportunities Fund, borrowing a total of $20 million, with repayment beginning in July 2024 [3] - As of December 2024, Clene has $7 million of principal outstanding under the previous agreement, along with a final payment fee of $0.85 million, totaling approximately $7.9 million including a prepayment penalty [3] Group 3: Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on treating neurodegenerative diseases, including ALS and multiple sclerosis, through its investigational therapy CNM-Au8 [5] - CNM-Au8 aims to improve mitochondrial health and neuronal function, targeting mitochondrial function and reducing oxidative stress [5][6]