CVKD — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• We are late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. Our pipeline includes CAD-1005, tecarfarin, and frunexian. CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induce…

• Tecarfarin is a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease, those with left ventricular assist devices, and potentially those with Kawasaki d…

• Tecarfarin has received ODD and Fast Track designation from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage renal disease (“ESKD”) and atrial fibrillation (“AFib”). Tecarfarin also received an ODD from the FDA for the prevention of thromboembolism …

• On July 8, 2026, we submitted an application for tecarfarin for “Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease” for a Rare Pediatric Disease Designation (RPDD) with the FDA.

• Frunexian is an investigational intravenous Factor XIa inhibitor designed to provide anticoagulation for patients undergoing major cardiac surgery.

Text removed 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 added vs the prior filing · source: 10-Q · 2026-08-13

• On July 22, 2026, the SEC approved Nasdaq’s recently proposed rule changes to (i) adopt NASDAQ 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)) (“MVLS”) of at least $…

• Unlike many other Nasdaq continued listing standards, the new MVLS requirement does not provide a compliance or cure period before a Staff Delisting Determination is issued. Additionally, a request for a hearing before the Hearings Panel does not automatically stay the suspension of trading. While t…

• However, on July 29, 2026, Nasdaq’s new continued listing requirement requiring companies to maintain at least $5 million in MVLS was automatically stayed. For now, Nasdaq’s new $5 million MVLS continued listing requirement is not effective. The SEC must decide whether to review the approval and, if…

• There can be no assurance that our MVLS will remain at or above the $5 million threshold for periods long enough to comply with the new standard. Our MVLS may be adversely affected by factors outside of our control, including general market conditions, macroeconomic uncertainty, sector-specific deve…

• Our shift to a partnership and out-licensing strategy may not be successful, and we may be unable to advance our pipeline candidates or continue operations if we do not secure additional funding or strategic transactions.

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

• 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…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• On August 12, 2026, the Board appointed Quang X. Pham as our Chief Business Officer. In addition to his position as Chief Executive Officer, Mr. Pham has been performing the duties and responsibilities customarily performed by a Chief Business Officer, including business development and commercial o…

• During the six months ended June 30, 2026, no officer or director of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “nonRule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K, except as set forth below.

• During the fiscal quarter ended June 30, 2026, Quang X. Pham, our Chief Executive Officer, paused a Rule 10b5-1 trading arrangement (within the meaning of Rule 10b5-1(c) under the Securities Exchange Act of 1934, as amended) for the sale of shares of our Common Stock that was originally adopted on S…

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

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