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 ...

Clene Inc. (CLNN) closed the last trading session at $5.65, gaining 24.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $55 indicates an 873.5% upside potential.The average comprises five short-term price targets ranging from a low of $20 to a high of $100, with a standard deviation of $38.64. While the lowest estimate indicates an increase of 254% from the current price level, t ...

Clene Inc. (CLNN) closed the last trading session at $5.11, gaining 2.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $55 indicates a 976.3% upside potential.The average comprises five short-term price targets ranging from a low of $20 to a high of $100, with a standard deviation of $38.64. While the lowest estimate indicates an increase of 291.4% from the current price level, t ...

Clene Inc. (CLNN) came out with a quarterly loss of $1.06 per share versus the Zacks Consensus Estimate of a loss of $1.60. This compares to loss of $2.40 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 33.75%. A quarter ago, it was expected that this company would post a loss of $1.80 per share when it actually produced a loss of $1.80, delivering no surprise.Over the last four quarters, the company has surpassed consensus EP ...

Survival analyses with CNM-Au8® 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baseline CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and survival (CAFS scores) compared to NfL non-responders CNM-Au8 demonstrated neuroprotective effec ...