CVKD — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We are a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. As a result of our acquisition of a 12-lipoxygenase (“12-LOX”) platform of assets in December 2025, we shifted our primary strategic focus to developing CAD-1005 for the tre…

• We achieved a major regulatory milestone after completing our End-of-Phase 2 (“EOP2”) meeting with the U.S. Food and Drug Administration (“FDA”) and receiving guidance on key elements of the Phase 3 pivotal trial for CAD-1005. The meeting with the FDA provided critical guidance on protocol design, s…

• We expect that our planned pivotal Phase 3 study will evaluate CAD-1005 in approximately 120 patients across clinical centers worldwide and is intended to support a projected NDA submission in 2029. The primary endpoint of the Phase 3 study is expected to be the incidence of new or worsening thrombo…

• Our broader pipeline includes two additional clinical-stage assets — tecarfarin and frunexian. Tecarfarin is an oral vitamin K antagonist (“VKA”) (a warfarin replacement for patients with complex needs) designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chr…

• On March 31, 2026, we entered into a warrant inducement letter agreement (the “Inducement Agreement”) with a holder of warrants to purchase shares of our common stock, par value $0.001 per share (the “common stock”), issued in a private placement offering that closed on November 4, 2024 (the “Existi…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Cadrenal is focused on developing novel differentiated products to address key gaps in currently available anticoagulation therapeutics. Our lead product candidate is tecarfarin, a novel late-stage, reversible Vitamin K antagonist (a warfarin replacement) designed to prevent heart attacks, strokes, …

• At the time the initial investigational new drug (“IND”) application for tecarfarin was filed by its founding sponsor, warfarin was the only marketed oral anticoagulant, and the strategy was to develop tecarfarin as an alternative vitamin K antagonist (“VKA”) with superior efficacy and safety over w…

• While tecarfarin clinical trials were being conducted by the initial IND sponsor, the direct-acting oral anticoagulants (“DOACs”) were advancing through clinical trials and ultimately approved after demonstrating that they were non-inferior to warfarin in specific indications, including AFib in the …

• Accordingly, we have refocused the development of tecarfarin for orphan cardiovascular conditions where patients are unable to achieve sufficiently reliable chronic anticoagulation with warfarin, and where DOACs have either failed or their efficacy and safety remain unproven, including patients with…

• Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin has orphan drug and fast-track designations from the United States Food and Drug Administration (“FDA”) for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with ESKD and AFib. Tec…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We cannot be assured that we will be able to maintain our listing on the Nasdaq Capital Market.

• Our securities are listed on The Nasdaq Capital Market, a national securities exchange. We cannot be assured that we will continue to comply with the rules, regulations or requirements governing the listing of our Common Stock on Nasdaq Capital Market or that our securities will continue to be liste…

• As reported in this Quarterly Report on Form 10-Q, at March 31, 2026, our stockholders’ equity of $1.8 million is below the minimum stockholders’ equity requirement of at least $2,500,000 for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders…

• The Nasdaq has recently proposed a new rule change to (i) adopt Listing Rule 5550(a)(6) to require issuers listed on the Nasdaq Capital Market to maintain a minimum Market Value of Listed Securities (as defined in Nasdaq Listing Rule 5005(a)(23)) of at least $5 million for a period of thirty (30) co…

• If Nasdaq delists our securities from trading on its exchange at some future date, we would take actions to restore our compliance with The Nasdaq Capital Market’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed aga…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• The shutdown of the U.S. federal government may adversely affect our business.

• A prolonged or recurring shutdown of the U.S. federal government may adversely affect our business operations and regulatory compliance. During such shutdowns, while the SEC’s EDGAR system remains operational, the unavailability of SEC staff to review filings, issue comments, or declare registration…

• Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ staffing and operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being …

• Currently, federal agencies in the United States are operating under a federal government shutdown due to the expiration of the continuing resolution that expired on September 30, 2025. The duration of the current government shutdown is unknown. In addition, the current U.S. administration is focuse…

• Our business depends on timely interactions with the FDA, including the review of regulatory submissions, scheduling of formal meetings, and oversight of clinical trials. Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, policy changes an…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• On September 23, 2025, Quang X. Pham, the Chief Executive Officer of the Company, entered into a written stock selling plan in accordance with Rule 10b5-1 of the Exchange Act and the Company’s Insider Trading Policy, which is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (…

• On September 18, 2025, Matthew Szot, the Chief Financial Officer of the Company, entered into a written stock selling plan in accordance with Rule 10b5-1 of the Exchange Act and the Company’s Insider Trading Policy, which is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (t…