SER 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-14

• Since inception our operations have been financed primarily by aggregate net proceeds from the issuance of common stock, private placements, convertible preferred stock, convertible notes, warrant exercises and our at-the-market ("ATM") program. Since our inception in 2006, we have had significant o…

• Commitments to issue common stock and warrants in connection with future equity financings are accounted for as outstanding contingently issuable instruments. The contingently issuable instruments are evaluated to determine if they are freestanding and their classification as equity or liability ins…

• recorded in the unaudited condensed consolidated statements of operations and comprehensive loss. Equity classified contingently issuable instruments are recorded at fair value upon issuance and are not subsequently remeasured.

• In January 2026, we announced that the FDA had cleared its IND application for SER-252, which allowed us to proceed with regulatory and site-level activities to support initiation of a planned Phase 1b registrational clinical study evaluating SER-252 in patients with advanced Parkinson’s disease and…

• We expect our research and development expenses to increase for the foreseeable future as we continue to implement our business strategy, which includes advancing SER-252 and our other product candidates, through clinical development, expanding our research and development efforts, including hiring …

相对上期删除的文字 · 来源:10-Q · 2025-11-13

• On March 26, 2024, we completed the Merger, pursuant to which Merger Sub merged with and into Legacy Serina, with Legacy Serina surviving as our wholly owned subsidiary. Additionally, on March 26, 2024, we changed our name to “Serina Therapeutics, Inc.”

• Our operations through September 30, 2025, have been financed primarily by aggregate net proceeds of $63.8 million from the issuance of convertible preferred stock, common stock, convertible notes and exercise of Post-Merger Warrants to purchase our common shares by Juvenescence. Since our inception…

• Our grants and contracts reimburse us for direct and indirect costs relating to the grant projects and also provide us with a pre-negotiated profit margin on total direct and indirect costs of the grant award, excluding subcontractor costs, after giving effect to directly attributable costs and allo…

• We expect our research and development expenses to increase for the foreseeable future as we continue to implement our business strategy, which includes advancing SER 252 and our other product candidates, through clinical development, expanding our research and development efforts, including hiring …

• Our general and administrative expenses consist primarily of personnel costs, and other expenses for outside professional services, including legal, recruiting, audit and accounting, and facility related costs not otherwise included in research and development expenses. Personnel costs consist of sa…

相对上期删除的文字 · 来源:10-Q · 2025-11-13

• In light of the conclusion that our disclosure controls and procedures are considered ineffective as of September 30, 2025, we have applied procedures and processes as necessary to ensure the reliability of our financial reporting in regard to this quarterly report. Accordingly, the Company believes…

• A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

• In the evaluation of our disclosure controls and procedures discussed above, we identified material weaknesses due to a lack of internal controls at the Company. Specifically, management has determined the following:

• •management does not have sufficient qualified accounting personnel to support the preparation of financial statements that comply with U.S. GAAP and SEC reporting requirements

• •a lack of validation of completeness and accuracy of internally prepared data, including key reports generated from systems, utilized in the operations of controls;

相对上期新增的文字 · 来源:10-Q · 2026-05-14

• Our March 2026 purchase agreement involving a member of our Board of Directors and related governance arrangements may result in conflicts of interest, dilution, stockholder approval risks, and increased investor influence over our affairs.

• In the March 2026 PIPE, Gregory H. Bailey, M.D., a current member of our Board of Directors, acting as lead investor, and certain other investors, purchased shares of the Company’s common stock, pre-funded warrants, and redeemable warrants. As a result of this transaction, and subject to stockholder…

• Although the transaction was reviewed and approved by a special committee of independent and disinterested directors, transactions involving directors may present actual or perceived conflicts of interest and may be subject to heightened scrutiny by stockholders, regulators, proxy advisory firms, or…

• In addition, pursuant to the March 2026 PIPE, Dr. Bailey was appointed as Co‑Chairman of our Board of Directors, and the investors obtained the right, subject to specified conditions, to designate an additional non‑executive director. These governance rights may lead to increased investor influence …

• Further, the issuance of shares to Dr. Bailey requires stockholder approval under NYSE American rules. If such approval is not obtained in a timely manner, or at all, the anticipated issuance of shares underlying the pre‑funded warrants will be delayed or may not occur, which could negatively affect…

相对上期删除的文字 · 来源:10-Q · 2025-11-13

• Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.

• We may sell up to $13.3 million of shares of our common stock in "at-the-market" offerings pursuant to a sales agreement (the "Sales Agreement") entered into on April 25, 2025 with JonesTrading Institutional Services LLC. The sale of a substantial number of shares of our common stock pursuant to the…

• The FDA regulatory approval process is lengthy, time consuming, and inherently unpredictable, and we may experience significant delays in the clinical development and regulatory approval, if any, of our product candidates.

• The research, testing, manufacturing, labeling, approval, selling, import, export, adverse event reporting, record keeping, advertising, promotion, and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States. We are not permi…

• Further, we are reliant on regulators having the resources necessary to evaluate and approve our products. In the United States, a partial federal government shutdown halted the work of many federal agencies and their employees from late December 2018 through late January 2019. A subsequent extended…