Clene(CLNN) - 2024 Q3 - Quarterly Report

Financial Performance - Total revenue for the three months ended September 30, 2024, was $87,000, a decrease of 19$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$22,000 [143]. - Total operating expenses for the three months ended September 30, 2024, were $7,902, down 18$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$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].