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].

Core Viewpoint - Clene Inc. has entered into a securities purchase agreement for the issuance and sale of common stock and warrants, aiming to raise approximately $7.3 million to fund clinical development and other corporate purposes [1][4]. Group 1: Securities Offering Details - Clene Inc. will issue 742,626 shares of common stock to a healthcare-focused institutional investor at a combined purchase price of $4.713 per share, along with warrants for the same number of shares [1]. - Current investors purchased 681,469 shares of common stock at the same price of $4.713 per share, also receiving warrants for the same number of shares [2]. - Directors and officers of Clene purchased 122,819 shares at a combined purchase price of $4.875 per share, with accompanying warrants [3]. Group 2: Financial Proceeds and Use of Funds - The gross proceeds from the offerings are expected to be approximately $7.3 million, which will be used for general corporate purposes, including funding clinical development of the lead drug candidate CNM-Au8® [4]. - The funds will also support ongoing and planned clinical trials, regulatory activities, and early-stage research and development [4]. Group 3: Regulatory and Compliance Information - The common stock offered is pursuant to a "shelf" registration statement filed with the SEC, and the offerings are expected to close on or about October 1, 2024 [5][4]. - The private placements are made in reliance on exemptions from registration under the Securities Act, and the company will register the shares for resale following the closing of the transactions [6][7]. Group 4: Company Overview - Clene Inc. is a clinical-stage biopharmaceutical company focused on improving mitochondrial health to treat neurological diseases, including ALS and MS [8]. - The lead drug candidate, CNM-Au8®, is an investigational therapy aimed at enhancing neuronal function and reducing oxidative stress [8].

SALT LAKE CITY, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) 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 today that it will meet in-person with the U.S. Food and Drug Administration (FDA) before the e ...

SALT LAKE CITY, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a 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), today announced that management will present at the H.C. Wainwright 26th Annual Global Investment Conference ...