Company Overview

We are developing tecarfarin, our drug candidate, for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions requiring chronic anticoagulation.

There is a lack of approved anticoagulation therapies for certain rare cardiovascular conditions requiring chronic anticoagulation, such as patients with left ventricular assist devices (LVADs), patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), and patients with catastrophic or thrombotic anti-phospholipid syndrome (APS). For these patients, treatment guidelines, and not FDA-approved labeling, recommend the use of 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.

Accordingly, we are focusing 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 LVADs, patients with ESKD and AFib, patients with mechanical heart valves and ESKD or resistant to warfarin, and patients with catastrophic or thrombotic APS, among others, where the need for VKA-dependent chronic anticoagulation has been underscored by recent clinical studies.

Tecarfarin has an orphan drug designation from 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).

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.

Private Placement

On July 12, 2023, we entered into a securities purchase agreement with an institutional investor pursuant to which we sold in a private placement priced at-the-market (i) an aggregate of 86,667 shares of Common Stock, (ii) pre-funded warrants to purchase up to an aggregate of 199,047 shares of Common Stock, and (iii) accompanying 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.

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. H.C. Wainwright & Co., LLC 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.

Warrant Inducement

On November 1, 2024, we entered into a warrant inducement letter agreement with a holder of outstanding warrants to purchase up to 285,715 shares of Common Stock issued in the July 2023 private placement. The holder exercised the warrants at a reduced exercise price of $16.50 generating approximately $4.7 million in gross proceeds. In consideration, we issued to the holder new unregistered Series A-1 and Series A-2 Common Stock purchase warrants to purchase an aggregate of 571,430 shares of Common Stock, equal to 100% of the number of shares issued upon exercise of the existing warrants.

ATM Facility

During the year ended December 31, 2024, we sold 391,243 shares of our Common Stock through our at-the-market (ATM) facility with H.C.W., generating gross proceeds of approximately $5.1 million and net proceeds of approximately $4.8 million.

From January 1, 2025 through March 13, 2025, we sold 72,224 shares of our Common Stock through our ATM facility with H.C.W. at a weighted average price of $20.29 per share, resulting in total gross proceeds of approximately $1,466,000 and net proceeds of approximately $1,419,000.

Results of Operations

The following table summarizes our results of operations for the fiscal year ended December 31, 2024 and 2023:

General and administrative expenses

General and administrative expenses increased by approximately $3.2 million, or 90%, from $3.5 million in 2023 to $6.8 million in 2024. This was primarily due to a $0.9 million increase in personnel-related expenses, a $1.4 million increase in expenses related to being a public company, a $0.7 million increase in stock-based compensation, and a $0.2 million increase in other general and administrative expenses.

Research and development expenses

Research and development expenses increased by $0.1 million, or 3%, from $4.1 million in 2023 to $4.2 million in 2024. Excluding a $3.0 million stock issuance expense in 2023, research and development expenses increased $3.1 million in 2024 due to a $1.9 million increase in chemistry, manufacturing, and controls (CMC) expenses, a $1.0 million increase in consulting fees, and a $0.1 million increase in personnel-related expenses.

Interest and dividend income

Interest and dividend income increased from $0.2 million in 2023 to $0.3 million in 2024 due to higher balances in money market funds.

Change in fair value of derivative liabilities

We recorded a non-cash charge of $0.2 million in January 2023 related to the increase in the fair value of derivative liabilities prior to their derecognition. We did not have such activity during the year ended December 31, 2024.

Loss on extinguishment of debt

We recorded a $0.7 million loss on the extinguishment of debt during the year ended December 31, 2023 related to the settlement of convertible notes and promissory notes concurrent with the IPO. We did not have such activity during the year ended December 31, 2024.

Liquidity and Capital Resources

Since inception, we have incurred losses and utilized cash in operations. As of March 13, 2025, we had cash and cash equivalents of approximately $7.9 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 Annual Report on Form 10-K. However, we will require additional funding to complete our planned Phase 3 clinical trial and submit our NDA.

The following table summarizes our cash flows for the years ended December 31, 2024 and 2023:

| | Years Ended December 31, |

Critical Accounting Estimates

The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Significant estimates and assumptions include the fair value of financial instruments, the fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals.

Stock-Based Compensation

We measure our stock-based awards granted to employees, consultants and directors based on the estimated grant-date fair values of the awards and recognize the compensation over the requisite service period. We use the Black-Scholes option-pricing model to estimate the fair value of our stock option awards. Stock-based compensation is recognized using the straight-line method, and is reduced by forfeitures, which are accounted for as they occur.

OFF-BALANCE SHEET ARRANGEMENTS

We did not have any off-balance sheet arrangements during the periods presented, and we do not currently have any such arrangements.