Clene(US:CLNN)2023-08-13 16:00Clinical Trials and Drug Development - Clene Inc. reported a statistically significant reduction in plasma neurofilament light chain (NfL) levels for CNM-Au8 treated participants compared to placebo after 24 weeks, with a p-value of 0.040[150]. - The LS Mean change of plasma NfL for CNM-Au8 was -0.024 (SE: 0.024) compared to +0.076 (SE: 0.042) for placebo, indicating a difference of -0.100 (SE: 0.048)[152]. - Clene Inc. plans to initiate an international Phase 3 study, RESTORE-ALS, in the first half of 2024, contingent on discussions with regulatory authorities[154]. - The company is discussing the design of an international Phase 3 MS study, expected to initiate in the second half of 2024, contingent on funding[155]. Financial Performance - Total revenue for Q2 2023 reached $269,000, a 669% increase compared to $35,000 in Q2 2022[171]. - Product revenue for Q2 2023 was $226,000, reflecting an increase of 11,200% from $2,000 in Q2 2022[171]. - Net loss for Q2 2023 was $25,143,000, a 455% increase compared to a net loss of $4,534,000 in Q2 2022[171]. - The company incurred a loss from operations of $21.1 million for the six months ended June 30, 2023, compared to a loss of $26.9 million for the same period in 2022[189]. - The accumulated deficit was $230.1 million as of June 30, 2023, compared to $193.2 million as of December 31, 2022[189]. Research and Development Expenses - Research and development expenses are anticipated to decrease in 2023 due to the completion of ongoing clinical trials but are expected to increase in future years as assets advance into Phase 3[163]. - Research and development expenses decreased by 28% to $6,615,000 in Q2 2023 from $9,166,000 in Q2 2022[171]. - Research and development expenses for the first half of 2023 totaled $14,010,000, a decrease of 21% from $17,746,000 in the first half of 2022[176]. - Stock-based compensation in research and development increased by 35% to $1,124,000 in Q2 2023 compared to $833,000 in Q2 2022[176]. Operating Expenses and Cash Flow - General and administrative expenses for Q2 2023 were $3,924,000, down 12% from $4,464,000 in Q2 2022[178]. - The company anticipates an increase in general and administrative expenses if an NDA is filed with the FDA, driven by drug development activities and commercial capabilities[168]. - The company expects general and administrative expenses to decrease if the NDA filing is not successful, leading to reduced commercial expansion projects[168]. - Net cash used in operating activities was $(16.2 million) for the six months ended June 30, 2023, compared to $(22.8 million) for the same period in 2022[189]. Funding and Capital Raising - The company raised approximately $37.4 million of net proceeds in an underwritten public equity offering during the three months ended June 30, 2023[192]. - The company plans to raise additional funding through equity financing, debt financing, and collaboration arrangements to support ongoing operations[192]. - In June 2023, the company sold 50,000,000 units at a sale price of $0.80 per unit, generating gross proceeds of $40.0 million[204]. Market and Economic Conditions - Clene Inc. is monitoring the impact of the COVID-19 pandemic on its operations, with no material disruptions reported to date[161]. - The company has no drugs approved for commercial sale and has not generated any revenue from drug sales, relying on dietary supplement sales for revenue[148]. - The company has incurred operating losses in each year since inception, with revenues from dietary supplements expected to be small compared to operating expenses[148]. Stock and Financial Metrics - The expected stock price volatility for the New Avenue Warrant was estimated at 90.00% to 110.00% as of June 30, 2023[216]. - The company terminated the ATM Agreement and the Purchase Agreement Prospectus Supplement on June 16, 2023, halting further sales of securities under these agreements[206][207]. - Probability of NDA acceptance is estimated at 30.00%[217]. - Probability of dissolution is high at 60.00%[217].