Cadrenal Therapeutics Inc

Previous wording

The prevailing treatment for thrombosis is with an oral anticoagulant, either a VKA, like warfarin, or non-vitamin K oral anticoagulant (“DOAC”). VKAs block the production of vitamin K-dependent blood clotting factors, such that the blood is “thinned,” preventing clots, while DOACs directly block the activity of certain of these clotting factors. Tecarfarin, like warfarin, is a VKA.

Current wording

We are developing tecarfarin, a new Vitamin K Antagonist (VKA) chronic anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to thrombosis (blood clots) in patients with implanted cardiac devices or rare cardiovascular conditions. The prevailing treatment for thrombosis is an oral anticoagulant, either a VKA, like warfarin, or a direct oral anticoagulant, (“DOAC”). VKAs block the production of vitamin K-dependent blood clotting factors, such that the blood is “thinned,” preventing clots, while DOACs directly block the activity of certain of these clotting factors. Tecarfarin, like warfarin, is a VKA.

Previous wording

We are developing tecarfarin, a new-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions who require lifelong anticoagulation. Tecarfarin has orphan drug designation from the U.S. Food and Drug Administration (the “FDA”) for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes the left ventricular assist device (LVAD). Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Tecarfarin is specifically designed to use a different metabolism pathway than the oldest and most commonly prescribed VKA warfarin.

Current wording

Tecarfarin has an orphan drug designation from the U.S. Food and Drug Administration (the “FDA”) for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes left ventricular assist device (LVAD), a heart pump. Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib).

Previous wording

Tecarfarin has been evaluated in eleven (11) human clinical trials in over 1,000 individuals (269 patients were treated for at least six months and 129 patients were treated for one year or more). In Phase 1, Phase 2 and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease (“CKD”). In the Phase 2/3 trial, EMBRACE-AC, the largest tecarfarin trial with 607 patients having completed it, only 1.6% of the blinded tecarfarin subjects suffered from major bleeding and there were no thrombotic events.

Current wording

Tecarfarin has been evaluated in eleven (11) human clinical trials in over 1,000 individuals; (269 patients were treated for at least six months and 129 patients were treated for one year or more). In Phase 1, Phase 2 and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease (“CKD”). In the Phase 2/3 trial, EMBRACE-AC, the largest tecarfarin trial with 607 patients having completed it including those with mechanical heart valves, only 1.6% of the blinded tecarfarin subjects suffered from major bleeding and there were no thrombotic events.

Previous wording

Tecarfarin was developed by researchers using a small molecule “retrometabolic” drug design process which targets a different metabolic pathway than the most commonly prescribed drugs for the treatment of thrombosis and AFib. “Drug metabolism” refers to the process by which a drug is inactivated by the body and rendered easier to eliminate or to be cleared by the body. Most approved drugs, including warfarin, the only FDA-approved Vitamin K antagonist (“VKA”), which is a prescribed drug for the treatment of thrombosis, are metabolized in the liver through a pathway known as the Cytochrome CYP450 system, or CYP450, by the enzymes known as CYP2C9 and CYP3A4. By using a different metabolic pathway, tecarfarin eliminates or minimizes the CYP450 metabolism in the liver. Patients taking multiple medications that interact with CYP2C9, or CYP3A4 or those with impaired kidney function, can experience an overload in the pathway, creating a bottleneck that often leads to insufficient clearance, which results in a toxic build-up of one or more drugs. In some instances, patients taking multiple medications metabolized by the same CYP450 pathway may experience decreased efficacy of one or more of the medications due to rapid metabolism or increased drug effect and/or toxicity due to enzyme induction. Patient-specific genetic differences can also hinder drug clearance in the CYP450 pathway. Our product candidate tecarfarin was designed to follow a metabolic pathway distinct from the CYP450 pathway and is metabolized by both CYP450 and non-CYP450 pathways. We believe this may allow elimination by large capacity and non-saturable tissue esterase pathways that exist throughout the body rather than just in the liver.

Current wording

By using a different metabolic pathway, tecarfarin eliminates or minimizes the CYP450 metabolism in the liver. Patients taking multiple medications that interact with CYP2C9, or CYP3A4, or those with impaired kidney function, can experience an overload in the pathway, creating a bottleneck that often leads to insufficient clearance, which results in a toxic build-up of one or more drugs. In some instances, patients taking multiple medications metabolized by the same CYP450 pathway may experience decreased efficacy of one or more of the medications due to rapid metabolism or increased drug effect and/or toxicity due to enzyme induction. Patient-specific genetic differences can also hinder drug clearance in the CYP450 pathway. Our product candidate tecarfarin was designed to follow a metabolic pathway distinct from the CYP450 pathway and is metabolized by both CYP450 and non-CYP450 pathways. We believe this may allow elimination by large capacity and non-saturable tissue esterase pathways that exist throughout the body rather than just in the liver.

Previous wording

On January 24, 2023, we consummated our initial public offering (the “IPO”) of 1,400,000 shares of our common stock, par value $0.001 per share (the “common stock”) at a public offering price of $5.00 per share, generating gross proceeds of $7,000,000. Our shares of common stock commenced trading on the Nasdaq on January 20, 2023 under the symbol “CVKD.”

Current wording

On January 24, 2023, we consummated our initial public offering (the “IPO”) of 93,333 shares of our common stock, par value $0.001 per share (the “common stock”) at a public offering price of $75.00 per share, generating gross proceeds of $7,000,000. Our shares of common stock commenced trading on the Nasdaq on January 20, 2023 under the symbol “CVKD.”

Previous wording

On July 12, 2023, we entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”) pursuant to which we sold to the Investor in a private placement priced at-the-market (the “Private Placement”) consistent with the rules of the Nasdaq), (i) an aggregate of 1,300,000 shares of common stock, (ii) in lieu of additional share of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 2,985,715 shares of common stock, and (iii) accompanying common warrants (the “Common Warrants”) to purchase up to an aggregate of 4,285,715 shares of common stock. The combined purchase price of each share and accompanying Common Warrants was $1.75. The combined purchase price of each Pre-Funded Warrant and accompanying Common Warrants was $1.7499.

Current wording

On July 12, 2023, we entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”) pursuant to which we sold to the Investor in a private placement priced at-the-market (the “Private Placement”) consistent with the rules of the Nasdaq), (i) an aggregate of 86,667 shares of common stock, (ii) in lieu of additional share of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 199,047 shares of common stock, and (iii) accompanying common warrants (the “Common Warrants”) to purchase up to an aggregate of 285,715 shares of common stock. The combined purchase price of each share and accompanying Common Warrants was $26.25. The combined purchase price of each Pre-Funded Warrant and accompanying Common Warrants was $26.25.

Previous wording

The Private Placement closed on July 14, 2023. We received aggregate gross proceeds from the Private Placement of approximately $7.5 million before deducting the placement agent commissions and estimated offering expenses payable by us. We intend to use the net proceeds from the Private Placement for working capital purposes. H.C. Wainwright & Co., LLC (“H.C.W.”) acted as the placement agent in the Private Placement, and as part of its compensation, we issued to designees of H.C.W. Placement Agent Warrants to purchase up to 278,571 shares of common stock.

Current wording

The Private Placement closed on July 14, 2023. We received aggregate gross proceeds from the Private Placement of approximately $7.5 million before deducting the placement agent commissions and estimated offering expenses payable by us. We intend to use the net proceeds from the Private Placement for working capital purposes. H.C. Wainwright & Co., LLC (“H.C.W.”) acted as the placement agent in the Private Placement, and as part of its compensation, we issued to designees of H.C.W. Placement Agent Warrants to purchase up to 18,571 shares of common stock.

Previous wording

General and administrative expenses were $2,338,430 for the six months ended June 30, 2024 compared to $1,749,356 for the six months ended June 30, 2023. The $589,074, or 34%, increase can be attributed to a $395,744 increase in personnel-related expenses as we hired a Chief Operating Officer in February 2024, a $214,522 increase in public company expenses, and a $34,317 increase in professional fees. These increases were partially offset by a $48,253 decrease in consulting expenses and a $105,361 decrease in stock-based compensation.

Current wording

General and administrative expenses were $1,674,905 for the three months ended September 30, 2024 compared to $898,051 for the three months ended September 30, 2023. The $776,854, or 87%, increase can be primarily attributed to a $192,948 increase in personnel-related expenses as a result of the hiring of a Chief Operating Officer in February 2024 as well as annual pay raises for management in January 2024, a $422,147 increase in public company expenses, a $141,304 increase in stock-based compensation, and a $77,456 increase in professional fees and other expenses. These increases were partially offset by a $45,535 decrease in consulting expenses.

Previous wording

Research and development expenses were $1,253,711 for the three months ended June 30, 2024, compared to $240,957 for the three months ended June 30, 2023. The $1,012,754, or 420%, increase can be primarily attributed to a $671,300 increase in expenses associated with chemistry, manufacturing and controls (“CMC”), a $287,878 increase in consulting fees, and a $37,403 increase in personnel-related expenses.

Current wording

Research and development expenses were $784,646 for the three months ended September 30, 2024, compared to $243,948 for the three months ended September 30, 2023. The $540,698, or 222%, increase can be primarily attributed to a $291,155 increase in expenses associated with chemistry, manufacturing and controls (“CMC”), a $213,078 increase in consulting fees, and a $19,102 increase in personnel-related expenses.

Previous wording

Interest and dividend income was $73,636 for the three months ended June 30, 2024. This represents the interest and dividend income earned from our investments in money market funds from the proceeds of our IPO and July 2023 Private Placement. Interest and dividend income was $23,176 for the three months ended June 30, 2023. The increase in interest and dividend income can be attributed to the proceeds received from the July 2023 Private Placement financing.

Current wording

Interest and dividend income was $52,129 for the three months ended September 30, 2024. This represents the interest and dividend income earned from our investments in money market funds from the proceeds of our IPO and July 2023 Private Placement. Interest and dividend income was $106,145 for the three months ended September 30, 2023. The decrease in interest and dividend income in the current quarter can be attributed to lower balances in money market funds.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2024 and June 30, 2023.

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2024 and September 30, 2023.

Previous wording

General and administrative expenses were $1,212,437 for the three months ended June 30, 2024 compared to $784,623 for the three months ended June 30, 2023. The $427,814, or 55%, increase can be attributed to a $279,767 increase in personnel-related expenses as we hired a Chief Operating Officer in February 2024, a $109,146 increase in public company expenses, and a $118,356 increase in professional fees and other expenses. These increases were partially offset by a $89,428 decrease in consulting expenses.

Current wording

General and administrative expenses were $4,013,336 for the nine months ended September 30, 2024 compared to $2,647,407 for the nine months ended September 30, 2023. The $1,365,929, or 52%, increase can be primarily attributed to a $588,693 increase in personnel-related expenses as we hired a Chief Operating Officer in February 2024 as well as annual pay raises for management in January 2024, a $636,669 increase in public company expenses, and a $61,139 increase in professional fees. These increases were partially offset by a $93,788 decrease in consulting expenses.

Previous wording

Research and development expenses were $1,882,736 for the six months ended June 30, 2024 compared to $3,476,274 for the six months ended June 30, 2023. The prior period included a $3.0 million expense for the issuance of 600,000 shares of common stock (valued at $3.0 million) in January 2023 to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase Agreement. This $3.0 million decrease was partially offset by a $803,265 increase in expenses associated with chemistry, manufacturing and controls (“CMC”), a $452,955 increase in consulting fees, a $85,970 increase in personnel-related expenses and a $57,585 increase in professional fees.

Current wording

Research and development expenses were $2,667,382 for the nine months ended September 30, 2024 compared to $3,720,222 for the nine months ended September 30, 2023. The prior period included a $3.0 million expense for the issuance of 40,000 shares of common stock (valued at $3.0 million) in January 2023 to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase Agreement. This $3.0 million decrease was partially offset by a $1,094,419 increase in expenses associated with chemistry, manufacturing and controls (“CMC”), a $666,033 increase in consulting fees, a $105,073 increase in personnel-related expenses, and a $69,120 increase in professional fees.

Previous wording

The derivative liabilities were considered a level 3 fair value financial instrument and were remeasured up to January 24, 2023 which was the date of derecognition. We recorded a non-cash charge of $216,095 in January 2023. This charge represented the increase in the fair value of the derivative liabilities since the previous measurement date of December 31, 2022. We did not have such activity during the six months ended June 30, 2024.

Current wording

The derivative liabilities were considered a level 3 fair value financial instrument and were remeasured up to January 24, 2023 which was the date of derecognition. We recorded a non-cash charge of $216,095 in January 2023. This charge represented the increase in the fair value of the derivative liabilities since the previous measurement date of December 31, 2022. We did not have such activity during the nine months ended September 30, 2024.

Previous wording

We recorded a $740,139 loss on the extinguishment of debt during the six months ended June 30, 2023. This loss represented the unamortized debt discount associated with the convertible notes and the November promissory notes, which were settled concurrent with the IPO. We did not have such activity during the six months ended June 30, 2024.

Current wording

We recorded a $740,139 loss on the extinguishment of debt during the nine months ended September 30, 2023. This loss represented the unamortized debt discount associated with the convertible notes and the November promissory notes, which were settled concurrent with the IPO. We did not have such activity during the nine months ended September 30, 2024.

Previous wording

Since inception, we have incurred losses and negative cash flows from operations. To date, we have funded our operations from the proceeds of the sale of convertible notes, and the nonconvertible notes and warrants issued in November 2022, as well as our IPO completed in January 2023 and our Private Placement consummated in July 2023. We had a net loss of $4,056,270 for the six months ended June 30, 2024 which included $356,707 of non-cash expenses. Cash used in operating activities for the six months ended June 30, 2024 totaled $3,365,624. As of June 30, 2024, we had cash and cash equivalents of approximately $5.0 million and no debt. Our current cash and cash equivalents balance as of August 7, 2024 of approximately $4.2 million, is not sufficient to fund our operations for at least the next twelve months

Current wording

Since inception, we have incurred losses and negative cash flows from operations. To date, we have funded our operations from the proceeds of the sale of convertible notes, and the nonconvertible notes and warrants issued in November 2022, as well as our IPO completed in January 2023, our Private Placement consummated in July 2023, and the sale of common stock through our ATM facility. We had a net loss of $6,464,099 for the nine months ended September 30, 2024 which included $656,987 of non-cash expenses. Cash used in operating activities for the nine months ended September 30, 2024 totaled $5,566,844. As of November 7, 2024, we had cash and cash equivalents of approximately $11.3 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 complete our planned Phase 3 clinical trial and submit our New Drug Application.

Previous wording

During the six months ended June 30, 2024, cash used in operating activities was $3,365,624. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $3,699,563 in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, provided $333,939 in cash primarily from a $592,199 increase in accounts payable partially offset by a $171,384 increase in deferred offering costs, and a $145,273 increase in prepaid expenses.

Current wording

During the nine months ended September 30, 2024, cash used in operating activities was $5,566,844. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $5,807,112 in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, provided $240,268 in cash primarily from a $329,504 increase in accounts payable partially offset by a $116,884 increase in deferred offering costs, and a $102,033 increase in prepaid expenses.

Previous wording

During the six months ended June 30, 2023, cash used in operating activities was $2,208,102. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $1,751,614 in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $456,488 in cash primarily from a decrease in accrued liabilities of $591,745 and a decrease in accounts payable of $326,758, partially offset by a $459,820 decrease in deferred equity offering costs and other prepaid expenses.

Current wording

During the nine months ended September 30, 2023, cash used in operating activities was $2,835,878. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $2,634,308 in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $201,570 in cash primarily from a decrease in accrued liabilities of $466,935 and a decrease in accounts payable of $263,239, partially offset by a $672,295 decrease in deferred equity offering costs.

Previous wording

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

Current wording

During the nine months ended September 30, 2024, net cash provided by financing activities totaled $1,528,244. During the period, we utilized our ATM facility, which generated proceeds of $1,527,946, net of fees. In addition, we had proceeds of $298 from the exercise of Pre-Funded Warrants.

Previous wording

During the six months ended June 30, 2023, net cash provided by financing activities totaled $5,408,575 as we completed our IPO of 1,400,000 shares of our common stock at a public offering price of $5.00 per share, generating gross proceeds of $7,000,000 and net proceeds of $5,408,575. We also received $250,000 from the exercise of warrants that we issued in November 2022, which proceeds were used to repay the notes that were issued in November, with accrued interest on the notes being paid in cash.

Current wording

During the nine months ended September 30, 2023, net cash provided by financing activities totaled $11,915,991 as we completed our IPO in January 2023, generating net proceeds of $5,408,575, and we completed a private placement financing in July 2023, generating net proceeds of $6,507,416. We also received $250,000 from the exercise of warrants that we issued in November 2022, which proceeds were used to repay the notes that were issued in November, with accrued interest on the notes being paid in cash.

Previous wording

We did not have during the period presented, and we do not currently have, any off-balance sheet arrangements, as defined under the U.S. Securities and Exchange Commission (the “SEC”) rules.

Current wording

We did not have during the period presented, and we do not currently have, any off-balance sheet arrangements, as defined under the SEC rules.