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]

Financial Performance - Clene Inc. reported a quarterly loss of $1.22 per share, which was better than the Zacks Consensus Estimate of a loss of $1.34, representing an earnings surprise of 8.96% [1] - The company posted revenues of $0.09 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 17.14%, compared to revenues of $0.11 million a year ago [2] - Over the last four quarters, Clene has surpassed consensus EPS estimates three times [2] Stock Performance - Clene shares have declined approximately 10.7% since the beginning of the year, while the S&P 500 has gained 25.5% [3] - The current status of estimate revisions for Clene is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$1.24 on revenues of $0.22 million, and for the current fiscal year, it is -$5.26 on revenues of $0.48 million [7] - The outlook for the industry, specifically the Medical - Biomedical and Genetics sector, is favorable, ranking in the top 26% of over 250 Zacks industries, which historically outperforms the bottom 50% by a factor of more than 2 to 1 [8]

Financial Performance - Clene reported a net loss of $8.0 million, or $1.22 per share, for Q3 2024, compared to a net loss of $2.4 million, or $0.38 per share, for the same period in 2023[11]. - Total revenue for Q3 2024 was $87,000, a decrease of 19.4% from $108,000 in Q3 2023[15]. - Product revenue remained stable at $65,000, while royalty revenue decreased by 48.8% to $22,000 compared to $43,000 in the same period last year[15]. - The net loss for Q3 2024 was $7,986, compared to a net loss of $2,418 in Q3 2023, representing a significant increase in losses[15]. - The accumulated deficit increased to $(268,574) from $(242,723), indicating a worsening financial position[17]. Cash and Assets - Clene reported cash, cash equivalents, and marketable securities of $14.6 million as of September 30, 2024, down from $35.0 million as of December 31, 2023[7]. - Cash and cash equivalents decreased to $14,645 from $28,821 at the end of 2023, indicating a cash reduction of 49.1%[16]. - Total assets decreased to $31,569 from $52,341, reflecting a decline of 39.5%[16]. - Total liabilities decreased to $35,694 from $38,951, a reduction of 5.8%[16]. Expenses - Research and development expenses for Q3 2024 were $4.5 million, a decrease of 25% compared to $6.0 million in Q3 2023[8]. - General and administrative expenses decreased to $3.4 million in Q3 2024 from $3.7 million in Q3 2023, reflecting a reduction in various operational costs[9]. - Total operating expenses decreased by 18.1% to $7,902, down from $9,650 in Q3 2023[15]. - Research and development expenses were $4,471, a reduction of 25.1% from $5,972 in Q3 2023[15]. Funding and Debt - Clene raised $7.3 million in gross proceeds through a registered direct offering and concurrent private placements on October 1, 2024[5]. - The funding from the October offering is expected to support operations into the first quarter of 2025[6]. - The company amended its debt agreement with Avenue Capital to defer principal payments and extend the maturity to the second quarter of 2025[4]. Clinical Trials and Approvals - Clene met with the FDA on November 1, 2024, to discuss an accelerated approval pathway for CNM-Au8 in ALS[2]. - Clene is preparing for the RESTORE-ALS Phase 3 clinical trial of CNM-Au8, which was presented at the 2024 Annual Northeast ALS Consortium[6]. Stock and Compliance - A 1-for-20 reverse stock split was executed in July 2024 to regain compliance with Nasdaq listing requirements[3]. Share Information - The weighted average common shares used to compute basic and diluted net loss per share increased to 6,557,839 from 6,420,274[15].

Financial Performance - Total revenue for the three months ended September 30, 2024, was $87,000, a decrease of 19% compared to $108,000 in the same period of 2023 [143]. - Product revenue remained flat at $65,000 for the three months ended September 30, 2024, while royalty revenue decreased by 49% to $22,000 [143]. - Total operating expenses for the three months ended September 30, 2024, were $7,902, down 18% from $9,650 in the same period of 2023 [143]. - Research and development expenses decreased by 25% to $4,471 for the three months ended September 30, 2024, compared to $5,972 in 2023 [147]. - General and administrative expenses decreased by 7% to $3,413 for the three months ended September 30, 2024, from $3,666 in 2023 [150]. - The net loss for the three months ended September 30, 2024, was $7,986, an increase of 230% compared to a net loss of $2,418 in the same period of 2023 [143]. - Total other income (expense), net, was $(171) for the three months ended September 30, 2024, compared to $7,124 in 2023, marking an 84% decrease [152]. - Interest income decreased by 77% to $127 for the three months ended September 30, 2024, from $546 in 2023 [152]. - Interest expense decreased by 14% to $(1,022) for the three months ended September 30, 2024, compared to $(1,188) in 2023 [152]. - The company incurred a loss from operations of $7.8 million for the three months ended September 30, 2024, compared to a loss of $9.5 million for the same period in 2023 [160]. - The accumulated deficit increased to $268.6 million as of September 30, 2024, up from $242.7 million as of December 31, 2023 [160]. - Cash, cash equivalents, and marketable securities totaled $14.6 million as of September 30, 2024, down from $35.0 million as of December 31, 2023 [160]. - Net cash used in operating activities was $16.5 million for the nine months ended September 30, 2024, compared to $23.0 million for the same period in 2023 [167][168]. - The company recorded other income of $0.1 million and $0.9 million for research and development tax credits for the nine months ended September 30, 2024, and 2023, respectively [155]. - Net cash provided by investing activities was $6.3 million for the nine months ended September 30, 2024, compared to $4.7 million for the same period in 2023 [170]. Research and Development - Clene Inc. has no drugs approved for commercial sale and has not generated any revenue from drug sales, relying on dietary supplement sales for revenue [124]. - The company plans to initiate an international confirmatory Phase 3 trial of CNM-Au8 30 mg for ALS in Q2 2025, pending FDA meeting outcomes and funding [129]. - Clene Inc. anticipates a decrease in research and development expenses throughout 2024 as Phase 2 clinical trials are completed, with potential increases if assets advance to Phase 3 [136]. - The company has initiated a second dosing cohort of REPAIR-MS for non-active progressive MS patients, expecting enrollment to conclude by the end of 2024 [130]. - Clene Inc. has incurred significant research and development expenses primarily related to its lead asset, CNM-Au8 [135]. - The company is working closely with regulatory authorities to support potential approval pathways for its drug candidates [130]. - The FDA granted accelerated approval to Biogen's tofersen for ALS, highlighting the competitive landscape for effective treatments in this area [133]. - The company expects to incur additional losses as it advances the development of its clinical-stage drug candidates and seeks regulatory approval [161]. Funding and Capital Structure - Clene Inc. completed a reverse stock split of 1-for-20 effective July 11, 2024, adjusting all outstanding stock options and warrants accordingly [127]. - The company raised $2.1 million from its equity distribution agreement during the three months ended September 30, 2024, and an additional $3.5 million from a registered direct offering post-quarter [162]. - The company has significant short-term cash requirements, including approximately $1.1 million in operating lease obligations and $11.0 million in notes payable [164]. - In June 2023, the company sold 2,500,000 units at a sale price of $16.00 per unit, generating gross proceeds of $40.0 million, with underwriting discounts and commissions totaling $2.4 million [172]. - For the three months ended September 30, 2024, the company sold 394,453 shares of Common Stock under the ATM Agreement, generating gross proceeds of $2.1 million [173]. - The company suspended the prospectus supplement related to the ATM Agreement on September 30, 2024, halting any sales of common stock under this agreement [173]. - The company will not make any sales of common stock pursuant to the Purchase Agreement until a new prospectus supplement is filed [174]. Other Financial Metrics - The company reported a gain of $0.1 million from the change in fair value of the 2023 Avenue Warrant during the three months ended September 30, 2024 [179]. - The fair value of the Tranche A Warrants resulted in a gain of $0.6 million during the three months ended September 30, 2024 [181]. - As of September 30, 2024, the carrying value of the 2022 DHCD Loan convertible note was $5.3 million [178]. - The expected stock price volatility for the 2023 Avenue Warrant ranged from 108.40% to 114.80% as of September 30, 2024 [180]. - The company has not recorded income tax benefits for net operating losses or deferred tax assets due to uncertainty in realizing benefits [183]. - The expected term of stock options for the nine months ended September 30, 2024 ranged from 5.00 to 10.00 years [186].