HUMAW 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• In addition to extremity vascular trauma, we and our collaborators are currently conducting Phase 3 and Phase 2 trials of our 6 millimeter ATEV in AV access for hemodialysis and PAD. We were granted Fast Track designation by the FDA for our 6 millimeter ATEV for use in AV access for hemodialysis in …

• In May 2023, we were granted the RMAT designation for the ATEV for urgent arterial repair following extremity vascular trauma, and in June 2024, we were granted the RMAT designation for the ATEV for patients with advanced PAD. In addition, in 2018 our ATEV product candidate was assigned a priority d…

• On April 21, 2026, we entered into the Third Amendment to our distribution agreement with Fresenius Medical Care. Pursuant to the amendment, we have the sole right to develop and commercialize, and conduct all regulatory matters relating to, the Distribution Product (as defined in the distribution a…

• We have incurred operating losses and negative cash flows from operations in each year since our inception in 2004. As of March 31, 2026 and December 31, 2025, we had an accumulated deficit of $744.5 million and $726.8 million, respectively, and working capital of $47.4 million and $49.4 million, re…

• Net cash flows used in operating activities were $25.1 million and $28.6 million during the three months ended March 31, 2026 and 2025, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from selling, gene…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• In addition to extremity vascular trauma, we and our collaborators are currently conducting Phase 3 and Phase 2 trials of our 6 millimeter ATEV in AV access for hemodialysis and PAD. We were granted Fast Track designation by the FDA for our 6 millimeter ATEV for use in AV access for hemodialysis in …

• We have incurred operating losses and negative cash flows from operations in each year since our inception in 2004. As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $702.0 million and $686.0 million, respectively, and working capital of $15.8 million and $27.9 million…

• Net cash flows used in operating activities were $78.9 million and $71.5 million during the nine months ended September 30, 2025 and 2024, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from selling, g…

• As of September 30, 2025, we had cash and cash equivalents of $19.5 million and restricted cash of $0.4 million. We believe our cash and cash equivalents on hand and existing capacity under our Common Stock Purchase Agreement will be sufficient to fund operations for at least 12 months from the date…

• Our need for additional capital will depend in part on the scope and costs of our development and commercial manufacturing activities, and the results of our commercial sales efforts. We recently received FDA approval to commercialize Symvess and have only recently generated revenue from the sale of…

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• Our risk factors are disclosed in Part I, Item 1A of our Annual Report. The risk factors set forth below supplement those disclosures and should be read together with the risk factors in our Annual Report. Except as set forth below, there have been no material changes to the risk factors previously …

• We have received a notice of delisting or failure to satisfy a continued listing rule from Nasdaq. If we are unable to regain or maintain compliance, our common stock could be delisted, which could adversely affect our stock price, liquidity, and ability to raise capital.

• On May 4, 2026, we received a letter from the staff of The Nasdaq Stock Market LLC providing notification that, for the 30 consecutive business days ended May 1, 2026, the bid price for the Company’s Common Stock had closed below the minimum $1.00 per share requirement for continued listing on The N…

• If we do not regain compliance during the initial compliance period, Nasdaq may issue a delisting determination with respect to our Common Stock, which could result in the delisting of our Common Stock from Nasdaq. We intend to monitor the bid price of the Common Stock and will consider options avai…

• assurance that we will regain compliance within the applicable compliance period or otherwise maintain compliance with Nasdaq’s continued listing requirements. Additionally, it is possible that the Public Warrants will be subject to delisting by Nasdaq if they do not satisfy applicable Nasdaq requir…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• Our risk factors are disclosed in Part I, Item 1A of our Annual Report. There have been no material changes during the nine months ended September 30, 2025 from, or updates to, the risk factors discussed in Part I, Item 1A, Risk Factors of our Annual Report, except as follows:

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• In May 2026, the Company implemented a plan to reduce its workforce by approximately 45 employees, defer additional planned new hires, and reduce other operating expenses. These reductions have been implemented thoughtfully, and the Company has retained key personnel, resources, and initiatives to m…

• During the three months ended March 31, 2026, no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of the Company adopted or terminated any “Rule 10b5-1 trading arrangement” or any “non Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• During the three months ended September 30, 2025, no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of the Company adopted or terminated any “Rule 10b5-1 trading arrangement” or any “non Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation …