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Cadrenal Therapeutics, Inc.

For the period ended Sep 30, 2025. Filed Nov 10, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 10, 2025

CVKD$0.98-2.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-11.

0001213900-25-073885

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-10.

0001213900-25-107816

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 49 previous paragraphs and 61 current paragraphs.

23 unchanged; 19 reworded; 19 added; 6 removed; 1 previous and 0 current paragraphs rearranged.

Tables are not compared: 3 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (19)

Current report

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report

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, and deaths due to blood clots in patients requiring chronic anticoagulation. Tecarfarin is specifically designed to overcome metabolic factors that can make warfarin less reliable. Cadrenal has also recently acquired the assets of eXIthera Pharmaceuticals (“eXIthera”), including its proprietary portfolio of investigational intravenous (“IV”) and oral Factor XIa inhibitors. The lead asset in this additional portfolio is frunexian, a first-in-class, Phase 2-ready IV Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices or artificial surfaces plays a significant role. Frunexian is the only IV FXIa inhibitor in clinical development targeting the acute/critical care hospital setting exclusively.

Current report

Over the course of the year, the development strategy for tecarfarin has continued to evolve. We are focused on the two areas for which we already have orphan designation - LVAD and ESKD with AFib. We have recently completed the manufacturing of tecarfarin drug product in accordance with current good manufacturing practices (cGMP) and are evaluating opportunities for additional Phase 2 trials that will provide important data to de-risk and streamline subsequent registration activities in both areas. This evaluation is ongoing and may include advancing clinical trials in 2026 for stable LVAD patients currently treated with warfarin and/or dialysis patients currently treated with warfarin who would be switched to tecarfarin.

Current report

On September 12, 2025, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with eXIthera Pharmaceuticals (“eXIthera”), to acquire its assets, including its proprietary portfolio of investigational IV and oral Factor XIa inhibitors, including the compounds known as frunexian (EP-7041) and EP-7327 and certain other compounds, as well as all intellectual property, regulatory filings (including two inactive Investigational New Drug Applications filed with the FDA), clinical and non-clinical data, Chemistry, Manufacturing, and Controls materials (“CMC”), drug substance inventory, books and records, and the exclusive license agreement (the “Haisco License Agreement”) with Sichuan Haisco Pharmaceutical Co., Ltd. (“Haisco”), which relates to development of eXIthera’s lead asset, frunexian, in the Chinese market (collectively, the “Assets”). The transactions contemplated by the Asset Purchase Agreement were consummated on September 12, 2025 (the “Closing”).

Current report

The Purchase Price for the Assets consists of (i) $50,000 of transaction closing costs, (ii) the assumption of specific assumed liabilities related to post-closing obligations arising from the Haisco License Agreement, (iii) certain milestone payments, and (iv) royalty payments. We have agreed to pay milestone payments to eXIthera in the aggregate amount of up to $15 million, payable in cash or in our common stock in our sole discretion, upon the achievement of the following clinical and regulatory milestone events:

Current report

The royalties due to eXIthera by us shall be calculated as follows: 2% of annual net sales of pharmaceutical products containing any of the compounds that are the subject of the Asset Purchase Agreement which are covered by a valid patent, payable from the first commercial sale of a product in each country until the later of: (a) expiration of the last-to-expire valid patent claim that would be infringed by the commercialization in that country, (b) expiration of regulatory exclusivity in that country (including when generic competition occurs), or (c) ten years from the first commercial sale of the product in that country. Additionally, we will pay eXIthera 50% of all royalties actually received by us from Haisco under the existing Haisco License Agreement following the potential future commercialization of frunexian by Haisco.

Current report

The Factor XIa inhibitors are the latest and most exciting class of broad-use anticoagulants currently under development around the world. The eXIthera acquisition significantly enhances our pipeline, adding product candidates that address large and underserved segments of the current $38 billion global anticoagulation market. Frunexian is a first-in-class, Phase 2-ready IV Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices or artificial surfaces plays a significant role, such as cardiopulmonary bypass, catheter thrombosis, and other blood-contacting implanted devices or artificial surfaces. The acquisition also includes EP-7327, an oral Factor XIa inhibitor, for the prevention and treatment of major thrombotic conditions.

Current report

These newly acquired small molecules are mechanism-based inhibitors, which bind to Factor XIa and inhibit enzyme activity. As a result, the product candidates are highly potent, which can be an advantage for a target like Factor XIa that requires a high degree of target engagement for efficacy. Unlike other IV small molecules under development, it is the only one specifically targeting the acute/critical care hospital setting. All other agents, whether small molecules or antibodies, are targeting chronic indications. Moreover, the non-small molecule inhibitors are not suited to acute use because of their pharmacodynamics. At present, only frunexian has the potential to replace heparin and other IV-delivered anticoagulants in select acute care hospital settings, with the potential to provide substantial cost savings to the US healthcare system. While the current standard of care for cardiac surgery is heparin, the high doses of heparin used for cardiopulmonary bypass have their own substantial risk of bleeding complications, especially with repeat cardiac surgical procedures.

Current report

Research and development expenses were $0.7 million for the three months ended September 30, 2025, compared to $0.8 million for the three months ended September 30, 2024, respectively, a decrease of $0.1 million, or 12%. The decrease was primarily attributable to a $0.3 million reduction in consulting expenses, partially offset by a $0.2 million increase in transaction-related expenses associated with the Asset Purchase Agreement completed in September 2025, which was expensed as in-process research and development (IPR&D). We anticipate research and development expenses to increase when we commence clinical trials.

Current report

Results of Operations for the Nine Months Ended September 30, 2025 and 2024

Current report

For the nine months ended September 30, 2025, we reported a net loss of $10.2 million, which included $1.6 million of non-cash expenses, and cash used in operating activities of $10.0 million. We expect to continue to incur operating losses and negative cash flows for the foreseeable future as we advance our clinical and regulatory activities. Based on our current operating plan, we believe that our existing cash resources will not be sufficient to fund our operating and capital requirements for the next 12 months. To meet anticipated funding needs, we plan to seek additional capital through strategic partnerships, equity offerings, and/or debt financings. However, there can be no assurance that additional funding will be available on acceptable terms or at all. These factors raise substantial doubt about our ability to continue as a going concern for at least one year following the issuance of the accompanying financial statements. If we are unable to obtain additional financing, we may be required to delay or reduce the scope of our development programs, implement cost-saving measures, or cease operations entirely. The accompanying financial statements do not include any adjustments that might result from this uncertainty.

Current report

During the nine months ended September 30, 2024, net cash provided by financing activities totaled $1.5 million. During the period, we utilized our ATM facility, which generated proceeds of $1.5 million, net of fees.

Current report

We evaluate acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or an asset acquisition by first applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If so, the transaction is accounted for as an asset acquisition. If not, further determination is required as to whether or not we have acquired inputs and processes that have the ability to create outputs, which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.

Current report

Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.

Current report

For asset acquisitions, a cost-accumulation model is used to determine the acquisition cost. Direct transaction costs are recognized as part of the cost of an asset acquisition. We also evaluate which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. When a transaction accounted for as an asset acquisition includes an in-process research and development (“IPR&D”) asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. For an IPR&D asset to have an alternative future use: (a) we must reasonably expect that we will use the asset acquired in the alternative manner and anticipate economic benefit from that alternative use, and (b) our use of the asset acquired is not contingent on further development of the asset subsequent to the acquisition date (that is, the asset can be used in the alternative manner in the condition in which it existed at the acquisition date). Otherwise, amounts allocated to IPR&D that have no alternative use are expensed to research and development. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis.
Removed paragraphs (6)

Previous report

We are developing tecarfarin, our lead 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 requiring chronic anticoagulation.

Previous report

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 report

On August 5. 2025, we announced our clinical trial initiation plans for our lead late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dialysis. Enrollment is expected to begin later this year and will include patients with and without atrial fibrillation (AFib).

Previous report

Research and development expenses for the three months ended June 30, 2025, and 2024 were $1.1 million and $1.3 million, respectively, representing a decrease of $0.2 million, or 14%. The decrease is primarily attributed to a $0.3 million decrease in consulting expenses partially offset by a $0.1 million increase in expenses associated with chemistry, manufacturing, and controls (“CMC”).

Previous report

Results of Operations for the Six Months Ended June 30, 2025 and 2024
Reworded paragraphs (19)

Previous wording

At the time the initial investigational new drug (IND) application for tecarfarin was filed by its initial sponsor, warfarin was the only marketed oral anticoagulant, and the strategy was to develop tecarfarin as an alternative VKA with superior efficacy and safety over warfarin for a broad range of indications including AFib, deep vein thrombosis (DVT), pulmonary embolism (PE), prevention of pulmonary embolism in patients with venous thrombosis, DVT prevention in patients undergoing certain surgical procedures, thrombosis prevention in patients with mechanical heart valves, and prevention of thrombotic complications in patients after a myocardial infarction (heart attack), among others.

Current wording

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 warfarin for a broad range of indications including atrial fibrillation (“AFib”), deep vein thrombosis (“DVT”), pulmonary embolism (“PE”), prevention of pulmonary embolism in patients with venous thrombosis, DVT prevention in patients undergoing certain surgical procedures, thrombosis prevention in patients with mechanical heart valves, and prevention of thrombotic complications in patients after a myocardial infarction (heart attack), among others.

Previous wording

While tecarfarin clinical trials were being conducted by the initial IND sponsor, the DOACs were advancing through clinical trials and ultimately approved after demonstrating that they were non-inferior to warfarin in certain indications, including AFib in the general population, prevention of pulmonary embolism in patients with venous thrombus, and prevention of deep vein thrombosis in patients undergoing certain surgical procedures, among others. These DOAC clinical studies resulted in a change in the standard of care for a large percentage of the population that had been previously treated with warfarin, and some of the same population that was initially targeted by the prior tecarfarin IND sponsor. Thus, the original broad-label development plan for tecarfarin became much more challenging.

Current wording

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 general population, prevention of pulmonary embolism in patients with venous thrombus, and prevention of deep vein thrombosis in patients undergoing specific surgical procedures, among others. These DOAC clinical studies led to a change in the standard of care for a large percentage of the population that had previously been treated with warfarin, as well as for some of the same population initially targeted by the prior tecarfarin IND sponsor. The DOACs also did not require monthly blood testing and monitoring, thus more convenient for patients. Therefore, the original broad-label development plan for tecarfarin had to be re-evaluated and modified.

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 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.

Current wording

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 end-stage kidney disease (“ESKD”) and AFib, and patients with left ventricular assist devices (“LVADs”). 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. At the same time, the quality of anticoagulation in warfarin-treated patients in these high-risk circumstances is frequently sub-optimal, and, importantly, sub-optimal anticoagulation is strongly associated with much higher adverse event rates. Thus, there continues to be a need for more reliable anticoagulation than can be achieved with warfarin in patients who are not addressed—or even addressable—by DOACs.

Previous wording

Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. 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).

Current wording

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. Tecarfarin also has an orphan drug designation from the FDA for the prevention of thrombosis and thromboembolism in patients with an implanted mechanical circulatory support device, which includes LVADs, a mechanical heart pump.

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, including those with mechanical heart valves, 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, 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

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.

Current wording

During the nine months ended September 30, 2025, we sold 236,728 shares of common stock through our at-the-market (ATM) facility with H.C.W. These sales were made at a weighted average price of $16.96 per share, resulting in total gross proceeds of approximately $4,015,598 and net proceeds of approximately $3,830,951.

Previous 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.

Current wording

From October 1, 2025 through November 10, 2025, we sold 16,091 shares of common stock through our at-the-market (ATM) facility. These sales were made at a weighted average price of $14.16 per share, resulting in total gross proceeds of approximately $227,772 and net proceeds of approximately $219,890.

Previous 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.

Current wording

General and administrative expenses were $2.0 million for the three months ended September 30, 2025, compared to $1.7 million for the three months ended September 30, 2024, an increase of approximately $0.4 million, or 22%. The increase was primarily driven by a $0.3 million increase in expenses related to being a public company, $0.2 million increase in stock-based compensation, and a $0.1 million increase in consulting expenses. These increases were partially offset by a $0.1 million decrease in patent expenses, $0.1 million decrease in personal-related expenses, and a $0.1 million decrease in other expenses.

Previous wording

Interest and dividend income for the three months ended June 30, 2025, and 2024 were $0.1 million and $0.1 million, respectively. This represents the interest and dividend income earned from our investments in money market funds.

Current wording

Interest and dividend income for the three months ended September 30, 2025, and 2024 were $0.1 million and $0.1 million, respectively. This income represents the interest and dividends earned from our investments in money market funds.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024.

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2025, and 2024.

Previous wording

General and administrative expenses for the three months ended June 30, 2025 and 2024 were $2.7 million and $1.2 million, respectively, representing an increase of approximately $1.4 million, or 119%. The increase is primarily attributed to a $0.6 million increase in expenses related to being a public company, a $0.4 million increase in stock-based compensation, a $0.2 million increase in annual Delaware franchise taxes, a $0.1 million increase in consulting expenses, and a $0.1 million increase in personnel-related expenses related to annual pay raises for management in January 2025.

Current wording

General and administrative expenses were $7.0 million for the nine months ended September 30, 2025, compared to $4.0 million for the nine months ended September 30, 2024, an increase of approximately $3.0 million, or 73%. The increase was primarily attributable to a $1.5 million increase in expenses related to being a public company, a $0.8 million increase in stock-based compensation, a $0.3 million increase in consulting expenses, and a $0.1 million increase in personnel-related expenses.

Previous 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.

Current wording

Research and development expenses were $3.4 million for the nine months ended September 30, 2025, compared to $2.7 million for the nine months ended September 30, 2024, an increase of $0.7 million, or 29%. The increase was primarily attributable to a $0.5 million increase in chemistry, manufacturing, and controls (“CMC”) expenses , a $0.3 million increase in personnel-related costs, primarily associated with our former Chief Medical Officer’s severance agreement entered into in February 2025, $0.2 million increase in transaction-related expenses associated with the Asset Purchase Agreement completed in September 2025, which was expensed as in-process research and development (IPR&D), a $0.1 million increase in stock-based compensation, and a $0.1 million increase in clinical trial preparation costs. These increases were partially offset by a $0.5 million decrease in consulting expenses. We anticipate research and development expenses to increase when we commence clinical trials.

Previous wording

Interest and dividend income for the six months ended June 30, 2025, and 2024 were $0.1 million and $0.2 million, respectively. This represents the interest and dividend income earned from our investments in money market funds.

Current wording

Interest and dividend income for the nine months ended September 30, 2025, and 2024 were $0.1 million and $0.2 million, respectively. This represents the interest and dividends earned from our investments in money market funds.

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 $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.

Current wording

Since inception, we have incurred recurring losses and used cash in operating activities as we continue to advance our development programs. To date, we have funded our operations primarily through the issuance of convertible and promissory notes, our initial public offering completed in January 2023, a private placement completed in July 2023, the warrant inducement transaction completed in November 2024, and the sale of common stock through our at-the-market (“ATM”) facility.

Previous wording

The following table summarizes our cash flow for the period presented:

Current wording

The following table summarizes our cash flows for the period presented:

Previous 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.

Current wording

During the nine months ended September 30, 2025, cash used in operating activities was $10.0 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $8.6 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $1.4 million in cash primarily from a $0.9 million decrease in accounts payable, a $0.4 million decrease in accrued liabilities, and a $0.1 million increase in deferred offering costs.

Previous 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.

Current wording

During the nine months ended September 30, 2024, cash used in operating activities was $5.6 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $5.8 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, provided $0.2 million in cash primarily from a $0.3 million increase in accounts payable, a $0.1 million increase in accrued liabilities partially offset by a $0.1 million increase in deferred offering costs, and a $0.1 million increase in prepaid expenses.

Previous 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.

Current wording

During the nine months ended September 30, 2025, net cash provided by financing activities totaled $3.9 million from the use of our ATM facility and proceeds from the exercise of stock options.

Previous wording

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these 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 made in the accompanying financial statements include but are not limited to 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. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimated under different assumption or conditions.

Current wording

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these 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 made in the accompanying financial statements include but are not limited to 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. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimated under different assumptions or conditions.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

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