Long term extension of the Phase 2 VISIONARY-MS clinical trial of CNM-Au8 demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05)Significantly improved clinical outcomes associated with long-term daily oral CNM-Au8® 30 mg treatment (change from original baseline; p<0.05)Long-term CNM-Au8 treatment, encompassing up to three years, was well-tolerated; no significant safety findings were observedFirst Phase 2 clinical MS trial ...

LOS ANGELES, March 19, 2024 (GLOBE NEWSWIRE) -- via IBN – IBN, a multifaceted communications organization engaged in connecting public companies with the investment community, today announces that Rob Etherington, President, Director and CEO of late clinical-stage biopharmaceutical company Clene Inc. (NASDAQ:CLNN), recently appeared on First in Human, a biotech-focused podcast featuring interviews with industry leaders and investors to learn about their journeys to in-human clinical trials. The podcast, hos ...

Proprietary catalytic gold nanocrystals comprising Clene's investigational drug CNM-Au8® develop a protein corona upon exposure to human blood plasma comprised of proteins that promote blood-brain barrier penetration, an important feature of the drug's neuroprotective mechanism of actionThe protein corona attracted by CNM-Au8 nanocrystals prevents aggregation upon entering the bloodstream, enabling the drug's longevity in circulation without provoking an inflammatory response SALT LAKE CITY, March 15, 2024 ...

Clene Inc. (CLNN) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.07. This compares to loss of $0.16 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 14.29%. A quarter ago, it was expected that this company would post a loss of $0.10 per share when it actually produced a loss of $0.02, delivering a surprise of 80%.Over the last four quarters, the company has surpassed consen ...

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, 2023 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 ...

Exhibit 99.1 CLENE REPORTS FULL YEAR 2023 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Initiated discussions with FDA regarding accelerated approval pathway for CNM-Au8® for the treatment of ALS with the objective of submitting an NDA in 2024 ● Released long-term data from the open-label extension of the HEALEY ALS Platform Trial in which CNM-Au8 demonstrated statistically significant reductions of plasma neurofilament light chain (NfL) levels at 76 weeks relative to placebo (18 months from randomiza ...

Core Viewpoint - Underappreciated penny stocks are highly unpredictable and often come with significant risks, but they also present opportunities for long-term price appreciation if investors are willing to speculate [1] Group 1: Gevo (GEVO) - Gevo is a renewable chemicals and advanced biofuels company focused on reducing greenhouse gas emissions in transportation sectors that cannot easily adopt electrification [2] - The global renewable hydrocarbon fuel market is projected to grow at a CAGR of 8.9% from 2023 to 2030, potentially reaching a value of $639.2 billion [2] - GEVO stock trades at 92 cents with a market capitalization of $220.2 million, and analysts project a price target of $4.80, indicating a 422% upside potential [3] Group 2: Eos Energy (EOSE) - Eos Energy specializes in zinc-based energy storage solutions, which could serve as a viable alternative to lithium-ion batteries [5] - EOSE stock is down about 13% over the past year but has a moderate buy rating with an average price target of $7.67, suggesting over 561% growth potential [6] Group 3: Velo3D (VLD) - Velo3D operates in the metal additive manufacturing sector, which was valued at $20.37 billion last year and is expected to grow at a CAGR of 23.3% to reach $88.28 billion by 2030 [7][8] - VLD stock has a market capitalization of under $70 million, with a price target of $2, indicating a 641% upside potential [8] Group 4: Knightscope (KSCP) - Knightscope develops security robots that address rising crime rates and labor shortages in law enforcement [10][11] - KSCP stock is rated a buy with a price target of $4, projecting a 649% growth potential [11] Group 5: Microvast (MVST) - Microvast focuses on battery technology for electric commercial vehicles and utility-scale storage systems, with the global EV battery market valued at $132.6 billion last year and expected to grow to $508.8 billion by 2033 [12] - MVST stock has a unanimous strong buy rating with an $8 target, translating to a 692% upside potential [13] Group 6: Quantum Computing (QUBT) - Quantum Computing specializes in quantum solutions, with the market size reaching $717.3 million in 2022 and projected to grow to about $6.53 billion by 2030, reflecting a CAGR of 32.1% [14][15] - QUBT stock has a price target of $8.75, indicating a growth potential of 1,068% [15] Group 7: Clene (CLNN) - Clene is a clinical-stage pharmaceutical company focused on clean-surfaced nanotechnology therapeutics, with the nanotechnology-based drug delivery market valued at $95.2 billion in 2022 and expected to grow to $308.4 billion by 2032 [16][17] - CLNN stock has a market cap of $54.3 million and is rated a strong buy with a price target of $7, suggesting a potential return of nearly 1,546% [17]

Core Insights - Clene Inc. reported significant long-term improvements in vision and cognition for participants with stable relapsing multiple sclerosis (RMS) treated with CNM-Au8 over a 35-month period, with p-values indicating strong statistical significance [1][3][7] Group 1: Clinical Trial Results - Long-term CNM-Au8 treatment showed improvement in low contrast visual acuity (LCLA) with a least-square mean difference of +8.70 letters at Week 144 compared to baseline, and +4.0 letters compared to the end of the double-blind period [2][3] - Cognitive improvement was measured by the Symbol Digit Modality Test (SDMT), showing a least-square mean difference of +8.03 at Week 144 versus baseline, and +3.11 compared to the end of the double-blind period [3][4] - Individual participants experienced sustained improvements in LCLA by up to 38 letters and cognitive improvements by up to 35 points, indicating notable enhancements in visual function and cognitive processing speed [2][3][4] Group 2: Study Design and Population - The VISIONARY-MS trial was a Phase 2 multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of CNM-Au8 in participants with chronic optic neuropathy [5] - The trial included nearly all participants (92%) on effective immunomodulatory disease-modifying therapies (DMTs) as background standard of care, with 73 participants randomized and 55 continuing into the long-term extension [5][6] - Placebo participants who transitioned to CNM-Au8 during the long-term extension also showed significant improvements in LCLA and SDMT, consistent with those originally assigned to CNM-Au8 [4][5] Group 3: Company Overview and Future Directions - Clene Inc. focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including multiple sclerosis [8] - The company is reviewing the trial data with prospective pharmaceutical partners interested in MS, indicating potential for future Phase 3 studies [7][8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission file number: 01-39834 | --- | --- | --- | |--------------------------------------------------------------------- ...

Clinical Trials and Drug Development - Clene Inc. reported a statistically significant reduction in plasma neurofilament light chain (NfL) levels for CNM-Au8 treated participants compared to placebo after 24 weeks, with a p-value of 0.040[150]. - The LS Mean change of plasma NfL for CNM-Au8 was -0.024 (SE: 0.024) compared to +0.076 (SE: 0.042) for placebo, indicating a difference of -0.100 (SE: 0.048)[152]. - Clene Inc. plans to initiate an international Phase 3 study, RESTORE-ALS, in the first half of 2024, contingent on discussions with regulatory authorities[154]. - The company is discussing the design of an international Phase 3 MS study, expected to initiate in the second half of 2024, contingent on funding[155]. Financial Performance - Total revenue for Q2 2023 reached $269,000, a 669% increase compared to $35,000 in Q2 2022[171]. - Product revenue for Q2 2023 was $226,000, reflecting an increase of 11,200% from $2,000 in Q2 2022[171]. - Net loss for Q2 2023 was $25,143,000, a 455% increase compared to a net loss of $4,534,000 in Q2 2022[171]. - The company incurred a loss from operations of $21.1 million for the six months ended June 30, 2023, compared to a loss of $26.9 million for the same period in 2022[189]. - The accumulated deficit was $230.1 million as of June 30, 2023, compared to $193.2 million as of December 31, 2022[189]. Research and Development Expenses - Research and development expenses are anticipated to decrease in 2023 due to the completion of ongoing clinical trials but are expected to increase in future years as assets advance into Phase 3[163]. - Research and development expenses decreased by 28% to $6,615,000 in Q2 2023 from $9,166,000 in Q2 2022[171]. - Research and development expenses for the first half of 2023 totaled $14,010,000, a decrease of 21% from $17,746,000 in the first half of 2022[176]. - Stock-based compensation in research and development increased by 35% to $1,124,000 in Q2 2023 compared to $833,000 in Q2 2022[176]. Operating Expenses and Cash Flow - General and administrative expenses for Q2 2023 were $3,924,000, down 12% from $4,464,000 in Q2 2022[178]. - The company anticipates an increase in general and administrative expenses if an NDA is filed with the FDA, driven by drug development activities and commercial capabilities[168]. - The company expects general and administrative expenses to decrease if the NDA filing is not successful, leading to reduced commercial expansion projects[168]. - Net cash used in operating activities was $(16.2 million) for the six months ended June 30, 2023, compared to $(22.8 million) for the same period in 2022[189]. Funding and Capital Raising - The company raised approximately $37.4 million of net proceeds in an underwritten public equity offering during the three months ended June 30, 2023[192]. - The company plans to raise additional funding through equity financing, debt financing, and collaboration arrangements to support ongoing operations[192]. - In June 2023, the company sold 50,000,000 units at a sale price of $0.80 per unit, generating gross proceeds of $40.0 million[204]. Market and Economic Conditions - Clene Inc. is monitoring the impact of the COVID-19 pandemic on its operations, with no material disruptions reported to date[161]. - The company has no drugs approved for commercial sale and has not generated any revenue from drug sales, relying on dietary supplement sales for revenue[148]. - The company has incurred operating losses in each year since inception, with revenues from dietary supplements expected to be small compared to operating expenses[148]. Stock and Financial Metrics - The expected stock price volatility for the New Avenue Warrant was estimated at 90.00% to 110.00% as of June 30, 2023[216]. - The company terminated the ATM Agreement and the Purchase Agreement Prospectus Supplement on June 16, 2023, halting further sales of securities under these agreements[206][207]. - Probability of NDA acceptance is estimated at 30.00%[217]. - Probability of dissolution is high at 60.00%[217].