Cadrenal Therapeutics, Inc.

Previous wording

There is a lack of approved anticoagulation therapies for certain conditions requiring chronic anticoagulation, such as patients with mechanical heart valves and conditions predisposing them to poor warfarin metabolism, patients with left ventricular assist devices (LVADs), and patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). For patients with these conditions, treatment guidelines, and not FDA-approved labeling, recommend using a vitamin K antagonist (VKA) such as warfarin, despite warfarin’s acknowledged challenges in achieving sufficiently stable and reliable anticoagulation in these patients. Additionally, direct-acting oral anticoagulants (DOACs) like Eliquis and Xarelto have either not shown clinical benefits in these and certain other patient populations, or their efficacy and safety remain uncertain.

Current wording

There is a lack of approved anticoagulation therapies for certain conditions requiring chronic anticoagulation, such as patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), patients with mechanical heart valves withconditions predisposing them to poor warfarin metabolism, and patients with left ventricular assist devices (LVADs). For patients with these conditions, treatment guidelines, and not FDA-approved labeling, recommend using a vitamin K antagonist (VKA) such as warfarin, despite warfarin’s acknowledged challenges in achieving sufficiently stable and reliable anticoagulation in these patients. Additionally, direct-acting oral anticoagulants (DOACs) like Eliquis and Xarelto have either not shown clinical benefits in these and certain other patient populations, or their efficacy and safety remain uncertain.

Previous wording

Accordingly, we are focusing on the development of tecarfarin for rare 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. These include patients with mechanical heart valves and conditions predisposing them to poor warfarin metabolism, patients with left ventricular assist devices (LVADs), and patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), where the need for VKA-dependent chronic anticoagulation has been underscored by recent clinical studies. While warfarin-treated patients have fared better than DOAC-treated patients in comparative studies in certain of these cardiovascular conditions, the event rates in these studies remain unacceptably high and the quality of anticoagulation in warfarin-treated patients has repeatedly been shown to be sub-optimal – hence, there continues to be unmet medical needs surrounding the use of warfarin in these patients that are not addressed – or not addressable - by DOACs.

Current wording

Accordingly, we are focusing on the development of tecarfarin for rare 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. These include patients with mechanical heart valves with conditions predisposing them to poor warfarin metabolism, patients with left ventricular assist devices (LVADs), and patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), where the need for VKA-dependent chronic anticoagulation has been underscored by recent clinical studies. While warfarin-treated patients have fared better than DOAC-treated patients in comparative studies in certain of these cardiovascular conditions, the event rates in these studies remain unacceptably high and the quality of anticoagulation in warfarin-treated patients has repeatedly been shown to be sub-optimal – hence, there continues to be unmet medical needs surrounding the use of warfarin in these patients that are not addressed – or not addressable - by DOACs.

Previous wording

From January 1, 2025 through March 31, 2025, we sold 102,246 shares of our Common Stock through our at-the-market (ATM) facility with H.C. Wainwright & Co., LLC (“H.C.W.”). These sales were made at a weighted average price of $20.10 per share, resulting in total gross proceeds of approximately $2,055,000 and net proceeds of approximately $1,970,000.

Current wording

During the six months ended June 30, 2025, we sold 186,294 shares of our common stock through our at-the-market (ATM) facility with H.C. Wainwright & Co., LLC (“H.C.W”). These sales were made at a weighted average price of $17.97 per share, resulting in total gross proceeds of approximately $3,348,000 and net proceeds of approximately $3,199,000.

Previous wording

From April 1, 2025 through May 7, 2025, we sold 56,943 shares of our common stock through our at-the-market (ATM) facility with H.C.W. These sales were made at a weighted average price of $15.92 per share, resulting in total gross proceeds of approximately $907,000 and net proceeds of approximately $876,000.

Current wording

From July 1, 2025 through July 14, 2025, we sold 39,741 shares of our common stock through our at-the-market (ATM) facility with H.C.W. These sales were made at a weighted average price of $12.97 per share, resulting in total gross proceeds of approximately $516,000 and net proceeds of approximately $499,000.

Previous wording

General and administrative expenses for the three months ended March 31, 2025 and 2024 were $2.3 million and $1.1 million, respectively, representing an increase of approximately $1.1 million, or 100%. The increase can be primarily attributed to a $0.7 million increase in expenses related to being a public company, a $0.2 million increase in stock-based compensation, and a $0.2 million increase in personnel-related expenses as we hired a Chief Operating Officer in February 2024 and implemented annual pay raises for management in January 2025.

Current wording

General and administrative expenses for the six months ended June 30, 2025 and 2024 were $4.9 million and $2.3 million, respectively, representing an increase of approximately $2.6 million, or 110%. The increase is primarily attributed to a $1.3 million increase in expenses related to being a public company, a $0.6 million increase in stock-based compensation, and a $0.2 million increase in personnel-related expenses as we hired a Chief Operating Officer in February 2024 and implemented annual pay raises for management in January 2025, a $0.2 million in increase in annual Delaware franchise taxes, and a $0.2 million increase in consulting expenses.

Previous wording

Research and development expenses for the three months ended March 31, 2025, and 2024 were $1.7 million and $0.6 million, respectively, representing an increase of $1.0 million, or 165%. The increase is primarily attributed to a $0.5 million increase in expenses associated with chemistry, manufacturing, and controls (“CMC), $0.1 million of clinical trial preparation costs, a $0.2 million increase in stock-based compensation, and a $0.3 million increase in personnel-related expenses related to our prior Chief Medical Officer’s severance agreement entered into in February 2025.

Current wording

Research and development expenses for the six months ended June 30, 2025, and 2024 were $2.7 million and $1.9 million, respectively, representing an increase of $0.9 million, or 46%. The increase is primarily attributed to a $0.5 million increase in expenses associated with CMC, a $0.3 million increase in personnel-related expenses related to our prior Chief Medical Officer’s severance agreement entered into in February 2025, a $0.2 million increase in stock-based compensation, and a $0.1 million increase in clinical trial preparation costs. These increases were offset by a $0.3 million decrease in consulting expenses.

Previous wording

Since inception, we have incurred losses and utilized cash in operations. To date, we have funded our operations from the proceeds of the sale of convertible and promissory notes, our initial public offering completed in January 2023, our Private Placement completed in July 2023, our Warrant Inducement completed in November 2024, and the sale of Common Stock through our ATM facility. We recognized a net loss of $3.8 million for the three months ended March 31, 2025 which included $0.6 million of non-cash expenses. Cash used in operating activities for the three months ended March 31, 2025 totaled $4.6 million. As of May 8, 2025, we had cash and cash equivalents of approximately $6.9 million, which is expected to be sufficient to fund our operations for at least the next twelve months from the date of the filing of this Quarterly Report on Form 10-Q, however, we will require additional funding to conduct any further late-stage clinical trials, including a Phase 3 clinical trial for tecarfarin.

Current wording

Since inception, we have incurred losses and utilized cash in operations. To date, we have funded our operations from the proceeds of the sale of convertible and promissory notes, our initial public offering completed in January 2023, our Private Placement completed in July 2023, our Warrant Inducement completed in November 2024, and the sale of common stock through our ATM facility. We recognized a net loss of $7.5 million for the six months ended June 30, 2025 which included $1.1 million of non-cash expenses. Cash used in operating activities for the six months ended June 30, 2025 totaled $7.7 million. As of August 11, 2025, we had cash and cash equivalents of approximately $5.0 million, which is expected to be sufficient to fund our operations for at least the next twelve months from the date of the filing of this Quarterly Report on Form 10-Q, however, we will require additional funding to conduct any further clinical trials, including a Phase 3 clinical trial for tecarfarin.

Previous wording

During the three months ended March 31, 2025, cash used in operating activities was $4.6 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $3.3 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $1.3 million in cash primarily from a $0.6 million decrease in accrued liabilities, a $0.2 million decrease in accounts payable and a $0.5 million increase in prepaid expenses.

Current wording

During the six months ended June 30, 2025, cash used in operating activities was $7.7 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $6.4 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $1.3 million in cash primarily from a $0.6 million decrease in accounts payable, a $0.4 million decrease in accrued liabilities, and a $0.3 million increase in prepaid expenses.

Previous wording

During the three months ended March 31, 2024, cash used in operating activities was $1.8 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $1.5 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $0.3 million in cash primarily from a $0.2 million decrease in accrued liabilities, a $0.2 million increase in prepaid expenses, and a $0.2 million increase in deferred offering costs partially offset by a $0.2 million increase in accounts payable.

Current wording

During the six months ended June 30, 2024, cash used in operating activities was $3.4 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $3.7 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, provided $0.3 million in cash primarily from a $0.6 million increase in accounts payable partially offset by a $0.2 million increase in deferred offering costs, and a $0.2 million increase in prepaid expenses.

Previous wording

During the three months ended March 31, 2025, net cash provided by financing activities totaled $2.0 million from the use of our ATM facility.

Current wording

During the six months ended June 30, 2025, net cash provided by financing activities totaled $3.2 million from the use of our ATM facility and proceeds from the exercise of stock options.

Previous wording

During the three months ended March 31, 2024, net cash provided by financing activities totaled $298 from the exercise of Pre-Funded Warrants.

Current wording

During the six months ended June 30, 2024, net cash provided by financing activities totaled $298 from the exercise of Pre-Funded Warrants.