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].

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, 2024 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 | --- | --- | --- | |--------------------------------------------------------------------- ...

SALT LAKE CITY, Sept. 30, 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 neurological diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that on September 30, 2024 it entered into a securities purchase agreement with a healthcare focus ...

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 ...