Nuwellis(US:NUWE)2025-11-12 21:19Financial Performance - For the three months ended September 30, 2025, net sales were $2.217 million, a decrease of 6.3% compared to $2.367 million for the same period in 2024 [106]. - The cost of goods sold for the three months ended September 30, 2025, increased by 8.6% to $772,000 from $711,000 in the prior year [107]. - Selling, general and administrative expenses rose by 31.0% to $3.539 million for the three months ended September 30, 2025, compared to $2.702 million in the same period in 2024 [107]. - Research and development expenses increased by 24.1% to $603,000 for the three months ended September 30, 2025, from $486,000 in the prior year [107]. - For the nine months ended September 30, 2025, net sales were $5.846 million, down 8.9% from $6.418 million in the same period in 2024 [111]. - The cost of goods sold for the nine months ended September 30, 2025, increased by 13.3% to $2.376 million from $2.097 million in the prior year [112]. - Selling, general and administrative expenses decreased by 2.3% to $10.305 million for the nine months ended September 30, 2025, compared to $10.544 million in the same period in 2024 [112]. - Research and development expenses decreased by 23.1% to $1.828 million for the nine months ended September 30, 2025, from $2.378 million in the prior year [112]. - As of September 30, 2025, the company reported an accumulated deficit of $313.9 million and expects to incur losses for the foreseeable future [98]. Financing Activities - The company completed a public offering on June 10, 2025, raising approximately $5.0 million by selling 61,444 shares of Common Stock and warrants, with the public offering price set at $12.60 per share [78]. - An At The Market Offering Agreement was established on September 3, 2025, allowing the company to sell shares with an initial aggregate offering price of up to $4,650,000, resulting in net proceeds of approximately $1.9 million from 447,288 shares sold by September 30, 2025 [86]. - The Company plans to seek additional financing in the future, primarily through offerings of equity securities [119]. - Net cash provided by financing activities was $5.8 million for the nine months ended September 30, 2025, compared to $6.2 million for the same period in 2024 [122]. - The Company is obligated to pay a sales agent commission of up to 3.0% on gross proceeds from the sale of Common Stock under the Sales Agreement [118]. Operational Changes - Nuwellis announced the termination of its REVERSE-HF clinical trial, expecting to save approximately $4.0 million over the next 2.5 years by reallocating resources to areas with greater potential for impact [83]. - The company decided to exit selected international operations to focus on the U.S. market, where it is experiencing the strongest growth and clinical demand [84]. - Nuwellis entered into a non-binding letter of intent to acquire Rendiatech, Ltd., aiming to expand its technology platform into continuous renal health monitoring technologies [85]. - The company made a contractual payment of $240,000 to KDI Precision Manufacturing to enhance manufacturing capabilities and streamline operations [81]. Stock and Warrant Information - The Series A and B warrants from the public offering were valued at $10.6 million and $3.9 million at issuance, respectively, with a decrease in warrant liability of $0.8 million reported by June 30, 2025 [79]. - As of September 30, 2025, the fair value of unexercised Series B warrants was $21,004, with the majority of the liability associated with these warrants removed due to their exercise into Common Stock [80]. - As of September 30, 2025, the Company sold 447,288 shares of Common Stock, generating total net proceeds of approximately $1.9 million [118]. Cash Flow and Liquidity - As of September 30, 2025, the Company had cash and cash equivalents of $3.1 million, down from $5.1 million as of December 31, 2024 [119]. - Net cash used in operating activities was $7.7 million for the nine months ended September 30, 2025, compared to $8.1 million for the same period in 2024 [120]. - Net cash used in investing activities was $102,000 for the nine months ended September 30, 2025, an increase from $37,000 in the prior year [121]. - The cash used in investing activities in 2025 was primarily for the purchase of loaner and demo console units and office equipment [121]. - The Company has no material commitments for capital expenditures as of September 30, 2025 [123]. Management Changes - Robert B. Scott resigned as Chief Financial Officer on October 24, 2025, with John L. Erb appointed as interim CFO [88]. Regulatory and Compliance Issues - Nuwellis, Inc. received a Deficiency Notice from Nasdaq due to the closing bid price of its Common Stock being below $1.00 for 30 consecutive trading days, leading to potential delisting unless a hearing is requested [77]. - Forward-looking statements indicate potential risks related to funding and regulatory approvals that could impact future operations [124].