Shares of RLX Technology Inc – ADR (NYSE:RLX) rose sharply in pre-market trading after the company reported financial results for the third quarter.RLX Technology reported quarterly earnings of 3 cents per share on $158.600 million in sales.RLX Technology shares jumped 6% to $2.47 in the pre-market trading session.Here are some other stocks moving in pre-market trading.GainersCidara Therapeutics, Inc. (NASDAQ:CDTX) surged 92% to $203.50 in pre-market trading. A Schedule 13D Amendment No. 4 filed Nov. 10 sho ...

IRVINE, CA / ACCESS Newswire / November 13, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received an unfavorable decision from the U.S. Food & Drug Administration ("FDA") in response to its supervisory appeal of the not-approvable letter it received on August 19, 2025 in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement veno ...

Core Insights - The company has sufficient cash and investments to fund current operations through Q2 2027, excluding VenoValve commercialization and the enVVe IDE study [1] - The cash burn for Q3 2025 was $4.2 million, which aligns with the projected quarterly range [1] - The company is engaged in an ongoing appeal with the FDA regarding the VenoValve PMA decision, with feedback anticipated by the end of 2025 [1] Financial Summary - The company ended Q3 2025 with $31.0 million in cash and investments [1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR (Address of principal executive offices) ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its ...

Watch the "What This Means" video here IRVINE, CA / ACCESS Newswire / September 26, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that Robert Berman, Chief Executive Officer of enVVeno Medical participated in a Virtual Investor "What This Means" segment. As part of the segment, Mr. ...

IRVINE, CA / ACCESS Newswire / September 15, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it will file a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) received on August 19, 2025, in response to its Premarket Approval (PMA) application for the VenoValve®, a ...

Key Takeaways NVNO stock sank 76.1% after the FDA issued a not-approvable letter for VenoValve.The FDA flagged insufficient NVNO's SAVVE study data and raised surgical safety concerns.NVNO eyes an IDE filing for its non-surgical enVVe valve as the next pipeline step.Shares of enVVeno Medical (NVNO) have crashed 76.1% since Aug. 19. The significant decline was due to the FDA’s not-approvable letter in response to its Premarket Approval (“PMA”) application for Veno Valve.The company submitted the PMA applicat ...

FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) (State or other jurisdiction of inco ...

Financial Performance - The company reported net losses of $4.5 million for Q1 2025, a decrease of 10% from $5.0 million in Q1 2024[56]. - Other income decreased by $0.1 million or 25% to $0.4 million for the three months ended March 31, 2025, compared to $0.5 million for the same period in 2024[60]. - The company incurred losses from operations of $5.0 million and used $4.0 million in operating activities for the three months ended March 31, 2025, an increase of $0.4 million from $3.6 million in the same quarter of 2024[61]. - The increase in cash usage is primarily due to product research and development activities, including clinical studies for VenoValve and enVVe[62]. - The company does not currently generate revenue and does not expect significant revenue until successful commercialization of product candidates after FDA approval[63]. Research and Development - Research and development expenses decreased by $0.5 million or 19% to $2.6 million in Q1 2025, primarily due to lower costs related to the VenoValve pivotal study[58]. - The VenoValve pivotal study reached full enrollment on September 1, 2023, and is currently in the post-enrollment follow-up period[47]. - The company expects to file for IDE approval for the enVVe pivotal study in Q3 2025[54]. - The VenoValve has shown an 85% clinical meaningful benefit at one year, with an average improvement of 7.91 points in the revised Venous Clinical Severity Score (rVCSS)[50]. - The VenoValve is estimated to be eligible for FDA approval in the second half of 2025[51]. - The increase in cash usage is primarily due to product research and development activities, including clinical studies for VenoValve and enVVe[62]. Financial Position and Capital Requirements - The company finished 2024 with approximately $43.2 million in cash and investments, with an expected increase in cash burn rate to $4 million to $5 million per quarter[55]. - Future capital requirements will depend on the success of clinical studies and product development costs, with an anticipated cash burn rate increasing to $5 million per quarter[65]. - The company has sufficient capital resources to meet obligations for at least one year after March 31, 2025, based on current cash and working capital[66]. - The company expects a modest increase in property and equipment purchases as it continues clinical studies and plans for commercialization of VenoValve[64]. Market Context - The total direct medical costs from venous ulcer sufferers in the U.S. exceed $3 billion annually[45]. - Approximately 20 million people in the U.S. are estimated to suffer from severe deep venous CVI (C4 to C6 disease) with reflux[45].

Financial Performance - The company reported net losses of $21.8 million for the year ended December 31, 2024, a decrease of 7% from the $23.5 million loss in 2023[173]. - The company incurred losses from operations of $23.8 million and used $16.8 million in cash for operating activities in 2024, a decrease from $18.9 million in 2023[179]. - The cash balance as of December 31, 2024, was $1.8 million, with total cash and investments amounting to $43.2 million[179]. - The company anticipates an increase in cash burn rate to $5 million to $6 million per quarter in 2025, while having sufficient cash to fund operations through mid-2026[183]. Expenses - Research and development expenses decreased by 10% to $12.2 million in 2024 from $13.6 million in 2023, primarily due to reduced costs for the SAVVE trial[174]. - Selling, general and administrative expenses decreased by 1% to $11.6 million in 2024, driven by a $1.1 million reduction in share-based compensation[176]. Income and Investments - Other income increased to $2.0 million in 2024 from $1.7 million in 2023, reflecting realized gains and interest from investments in U.S. Treasury securities[178]. - The company has no current revenue and relies on future commercialization of its products for potential income[172]. Future Plans - The company aims to receive FDA approval for the VenoValve in 2026 and has begun limited activities toward commercial launch[181]. - The company expects a modest increase in capital expenditures related to ongoing clinical trials and commercialization efforts[182].