Cadrenal Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 13, 2026.
View on SEC.govAbout 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.
Jun 30, 2026 · Filed Aug 13, 2026
CVKD$0.98-2.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001213900-26-053074
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001213900-26-089153
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 39 previous paragraphs and 72 current paragraphs.
23 unchanged; 13 reworded; 34 added; 3 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 2 previous and 6 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 (34)
Current report
Our Product Candidates:
Current report
Weare 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-induced thrombocytopenia (“HIT”)and Cardiac Surgery-Associated Acute Kidney Injury (“CSA-AKI”). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (“12-LOX”), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. CAD-1005 has an Orphan Drug Designation (“ODD”) from the U.S Food and Drug Administration (“FDA”) for prophylaxis of thrombosis in patients with HIT, FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the European Medicines Agency for the treatment of platelet-activating factor 4 disorders. Second-generation 12-LOX oral therapeutics (CAD-2000) are also in development for chronic indications.
Current report
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 disease (“KD”), an acute, self-limited, febrile illness that primarily affects children under 5 years old and is the leading cause of acquired heart disease in developed countries.
Current report
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 and thrombosis in patients with implanted mechanical circulatory support devices, including left ventricular assist devices (“LVADs”).
Current report
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.
Current report
Frunexian is an investigational intravenous Factor XIa inhibitor designed to provide anticoagulation for patients undergoing major cardiac surgery.
Current report
However, as discussed in more detail below, we do not currently have the funding to complete clinical trials for any of our product candidates. While we are continuing to advance our product candidates to clinical trial readiness, we do not plan to commence any trials until we have the funding in place to complete the trial. In order to meet our expected capital needs, management is focusing on securing additional funds, which may include the sale of equity, non-dilutive grants, debt financings, a strategic out-licensing and/or a co-development partnership. However, there can be no assurance that we will be able to complete partnering transactions or financings on terms acceptable to us or at all or that we will be awarded any grant funding.
Current report
Clinical Pipeline Expansion & Updates
Current report
Tecarfarin
Current report
We continue to leverage tecarfarin’s distinct metabolic pathway. Because it is metabolized via carboxylesterase-1 (CES-1) rather than the cytochrome P450 pathway, it avoids severe drug-drug interactions and genetic variations.
Current report
Our RPDD application provides a comprehensive scientific rationale for tecarfarin. In vitro and in vivo studies demonstrate that tecarfarin is a highly selective vitamin K epoxide reductase (VKOR) inhibitor with antithrombotic potency equivalent to warfarin. Unlike standard therapies, tecarfarin is metabolized via the human carboxyl esterase subunit 2 (hCE2) pathway rather than the hepatic cytochrome P450 system. This structural modification significantly reduces the risk of CYP2C9-mediated drug-drug interactions and patient-specific metabolic variability. Epidemiological data in the submission confirm that the estimated domestic prevalence of this condition falls well below the statutory threshold of 200,000 persons.
Current report
CAD-1005
Current report
CAD-2000
Current report
We are also advancing our preclinical platform asset, CAD-2000, a highly selective, orally bioavailable 12-LOX inhibitor designed to treat chronic cardiorenal inflammatory and thrombotic indications. CAD-2000 serves as a potent oral follow-on companion to our Cardiac Acute Critical Care Franchise, potentially enabling prospective partners to capture extended market share across both acute inpatient settings and chronic outpatient follow-up care.
Current report
Cardiac Acute Critical Care (CACC) Franchise
Current report
We advanced the mapping for our integrated CACC Franchise. This bundle combines our targeted anticoagulation and renal-protective therapies into a unified bedside protocol. It aims to reduce ICU length of stay and minimize mechanical ventilation days. We are finalizing the regulatory pathway to initiate a multi-center investigator-initiated trial to evaluate health economic outcomes, maximizing the bundle’s attractiveness to potential commercial partners.
Current report
Our Strategy
Current report
Our updated corporate strategy focuses on advancing our CACC Franchise through early- to mid-stage validation to secure strategic out-licensing, co-development partnerships, or an outright acquisition. We do not intend to independently fund or execute late-stage Phase 3 clinical trials for any of our three product candidates.
Current report
This shift in strategy is driven in part by our current capital constraints and historical challenges in securing sufficient capital on acceptable terms to fund the resource-intensive Phase 3 development. As of the date of the filing of this Quarterly Report on Form 10-Q, our existing cash and cash equivalents are insufficient to fund independent Phase 3 clinical trials. If we are unable to secure strategic partnerships, out-licensing agreements, or alternative non-dilutive funding such as grant funding within the next twelve months, we will lack the financial resources to sustain our operations. In such an event, we may be forced to delay, scale back, or eliminate our research and development programs, liquidate asset portfolios, or cease operations entirely. There can be no assurance that any strategic partnership or transaction will be consummated on favorable terms or at all.
Current report
For further discussion regarding our liquidity, capital resources, and the management evaluation that led to our substantial doubt about our ability to continue as a going concern, see Note 1—Liquidity to our financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Current report
The Cardiac Acute Critical Care (CACC) Franchise
Current report
Following a competitor’s recent Phase 3 failure in CSA-AKI, Cadrenal is highlighting the potential of its 12-LOX inhibitor to address a $1 billion+ market opportunity in this critical care space. CAD-1005 is being studied as a "Post-Operative Shield" that uses 12-lipoxygenase (12-LOX) inhibition to target platelet hyperactivation in HIT while simultaneously reducing inflammation-driven injury in patients with CSA-AKI. This dual-mechanism approach is supported by clinical data on CAD-1005 presented last month at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris. The late-breaking Phase 2 data for CAD-1005 demonstrated a compelling medical profile, with an absolute reduction in thrombotic events greater than 25% and a favorable safety profile and renal-protective baseline.
Current report
Our overarching corporate strategy focuses on building, validating, and positioning our targeted portfolio for strategic out-licensing, portfolio monetization, or commercial co-development partnerships. We recently announced the comprehensive alignment of our clinical portfolio into a Cardiac Acute Critical Care Franchise. Rather than deploying the extensive capital required for late-stage clinical development on an individual basis, our primary objective is to maximize asset value through early- to mid-stage validation, robust regulatory profiling, and portfolio integration. This franchise is built on three strategic pillars:
Current report
PIPE Transaction
Current report
On June 30, 2026, we entered into a securities purchase agreement with an investor, pursuant to which we issued and sold, in a private placement priced at-the-market under the rules of the Nasdaq Stock Market (the “PIPE Transaction”), (i) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 960,000 shares (the “Pre-Funded Warrant Shares”) of our common stock, par value $0.001 per share (the “Common Stock”), (ii) Series C-1 Common Stock warrants (the “Series C-1 Warrants”) to purchase up to an aggregate of 960,000 shares (the “Series C-1 Warrant Shares”) of Common Stock, and (iii) Series C-2 Common Stock warrants (the “Series C-2 Warrants” and, together with the Series C-1 Warrants, the “Common Warrants”) to purchase up to an aggregate of 960,000 shares (the “Series C-2 Warrant Shares” and, together with the Pre-Funded Warrant Shares and the Series C-1 Warrant Shares, the “PIPE Warrant Shares”) of Common Stock, at a combined purchase price of $3.1249 per Pre-Funded Warrant and accompanying Common Warrants. On July 1, 2026, we received aggregate gross proceeds of approximately $3.0 million, before deducting placement agent fees and other offering expenses.
Current report
The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately, and do not expire until exercised in full. The Series C-1 Warrants and Series C-2 Warrants each have an exercise price of $3.00 per share. The Series C-1 Warrants become exercisable beginning on the effective date of stockholder approval of the issuance of the Series C-1 Warrant Shares (the “Stockholder Approval”) and will expire five years after the later of the effective date of Stockholder Approval or the effective date of a resale registration statement registering for resale all of the Series C-1 Warrant Shares. The Series C-2 Warrants are exercisable immediately upon issuance and expire 24 months after the earliest of the date that (a) the initial registration statement registering for resale all Pre-Funded Warrant Shares and Series C-2 Warrant Shares has been declared effective by the SEC, (b) all of the PIPE Warrant Shares have been sold pursuant to Rule 144 or may be sold pursuant to Rule 144 without the requirement for us to be in compliance with the current public information required under Rule 144 and without volume or manner-of-sale restrictions, (c) following the one year anniversary of the closing of the PIPE Transaction, provided that a holder of PIPE Warrant Shares is not an affiliate of ours, or (d) all of the PIPE Warrant Shares may be sold pursuant to an exemption from registration under Section 4(a)(1) of the Securities Act, without volume or manner-of-sale restrictions (the “Effective Date”). A resale registration statement registering the resale of all of the PIPE Warrant Shares was declared effective by the SEC on July 20, 2026. We intend to seek Stockholder Approval at our 2026 annual meeting of stockholders, currently scheduled for September 24, 2026.
Current report
April 2026 Warrant Inducement
Current report
General and administrative expenses were $2.6 million for the three months ended June 30, 2026, compared to $2.7 million for the three months ended June 30, 2025, a decrease of approximately $0.02 million, or 1%.
Current report
Results of Operations for the Six Months Ended June 30, 2026 and 2025
Current report
General and administrative expenses
Current report
Research and development expenses
Current report
Research and development expenses for the six months ended June 30, 2026 and 2025 were $1.5 million and $2.7 million, respectively, representing a decrease of $1.3 million, or 46%. The decrease is primarily attributed to a $1.2 million decrease in expenses associated with CMC, a $0.3 million decrease in stock-based compensation, a $0.2 million decrease in personnel-related expenses, and a $0.1 million decrease in clinical trial preparation costs. These decreases were offset by a $0.5 million increase in consulting expenses.
Current report
Interest and dividend income
Current report
Interest and dividend income for the six months ended June 30, 2026 and 2025 were $0.1 million and $0.1 million, respectively. This represents the interest and dividend income earned from our investments in money market funds.
Removed paragraphs (3)
Previous report
The Company
Previous report
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 treatment of immune-mediated and thrombotic disorders. Our lead product candidate, CAD-1005, is a first-in-class selective 12-LOX inhibitor being developed to treat heparin-induced thrombocytopenia (“HIT”), a deadly immune-mediated thrombotic disorder. CAD-1005 has been evaluated in a blinded, placebo-controlled Phase 2 clinical trial of 24 patients and in Phase 1 clinical trials involving more than 100 patients.
Previous report
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 chronic anticoagulation. Specifically, our focus for tecarfarin is chronic use in patients with kidney dysfunction and atrial fibrillation, or in those with left ventricular assist devices (“LVADs”). Tecarfarin has been designed to overcome metabolic factors that can make warfarin less reliable. Frunexian is a first-in-class, Phase 2-ready intravenous (“IV”) Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices or artificial surfaces is significant. Frunexian is the only IV FXIa inhibitor in clinical development that targets the acute/critical care hospital setting exclusively.
Reworded paragraphs (13)
Previous wording
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, study population, dosing, background therapy, exposure, the safety database, and the primary endpoint of new or worsening thrombotic events. After considering FDA feedback on a pivotal registration study, we plan to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT.
Current wording
We achieved a regulatory milestone after completing our End-of-Phase 2 (“EOP2”) meeting with the FDA and receiving guidance on key elements of a Phase 3 pivotal trial for CAD-1005. The EOP2 meeting with the FDA provided critical guidance on protocol design, study population, dosing, background therapy, exposure, the safety database, and the primary endpoint of new or worsening thrombotic events. After considering FDA feedback on a pivotal registration study (a 120 patient randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT), we have concluded that we do not currently have sufficient funding to commence or complete such a trial and we do not plan to commence any trials until we have the funding in place to complete such trial and therefore our focus has been on preparing for clinical trial readiness.
Previous wording
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 thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis. We believe that CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT. Our Phase 3 trial protocol will remain subject to additional information and any further comments we may receive from the FDA during their review of the final protocol. CAD-1005 has an ODD from the FDA for prophylaxis of thrombosis in patients with HIT, an FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the EMA for the treatment of platelet-activating factor 4 disorders.
Current wording
If we should be successful in obtaining funding that would allow us to commence and complete the pivotal Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT, we expect that the pivotal Phase 3 study will evaluate CAD-1005 in approximately 120 patients across clinical centers worldwide and is intended to support a projected New Drug Application submission in 2029. The primary endpoint of the Phase 3 study is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis. We believe that CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT. Our Phase 3 trial protocol will remain subject to additional information and any further comments we may receive from the FDA during their review of the final protocol.
Previous wording
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 “Existing Warrants”). Pursuant to the Inducement Agreement, on April 1, 2026, the holder of the Existing Warrants exercised for cash the Existing Warrants to purchase up to an aggregate of 571,430 shares of common stock, at the adjusted exercise price of $4.50 per share (reduced from the initial exercise price of $16.50 per share) and, in consideration for the investor’s exercise of the Existing Warrants, we issued to such investor new unregistered Series B-1 common stock purchase warrants (the “Series B-1 Warrants”) to purchase an aggregate of 571,430 shares of common stock and new unregistered Series B-2 common stock purchase warrants (the “Series B-2 Warrants” and, together with the Series B-1 Warrants, the “New Warrants”) to purchase an aggregate of 571,430 shares of common stock. The New Warrants are immediately exercisable at an exercise price of $4.50 per share. The Series B-1 Warrants and the Series B-2 Warrants are exercisable for a term of five (5) years and eighteen (18) months, respectively, from the date that a resale registration statement registering the resale of the shares of common stock issuable upon exercise of the New Warrants (the “Resale Registration Statement”) is declared effective by the SEC. The Resale Registration Statement was declared effective on April 29, 2026.
Current wording
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, which warrants were issued in a private placement offering that closed on November 4, 2024 (the “Existing Warrants”). Pursuant to the Inducement Agreement, on April 1, 2026, the holder of the Existing Warrants exercised for cash the Existing Warrants to purchase up to an aggregate of 571,430 shares of Common Stock, at the adjusted exercise price of $4.50 per share (reduced from the initial exercise price of $16.50 per share) and, in consideration for the investor’s exercise of the Existing Warrants, we issued to such investor new unregistered Series B-1 Common Stock purchase warrants (the “Series B-1 Warrants”) to purchase an aggregate of 571,430 shares of Common Stock and new unregistered Series B-2 common stock purchase warrants (the “Series B-2 Warrants” and, together with the Series B-1 Warrants, the “New Warrants”) to purchase an aggregate of 571,430 shares of Common Stock. The New Warrants are immediately exercisable at an exercise price of $4.50 per share. We received aggregate gross proceeds of approximately $2.6 million from the exercise of the Existing Warrants, before deducting placement agent fees and other expenses payable by us. The Series B-1 Warrants and the Series B-2 Warrants are immediately exercisable for a term of five (5) years and eighteen (18) months, respectively, from the date that a resale registration statement registering the resale of the shares of Common Stock issuable upon exercise of the New Warrants (the “Resale Registration Statement”) is declared effective by the SEC. The Resale Registration Statement was declared effective on April 29, 2026.
Previous wording
The transactions contemplated by the agreement closed on April 1, 2026. We received aggregate gross proceeds of approximately $2.5 million from the exercise of the Existing Warrants, before deducting placement agent fees and other expenses payable by us. H.C. Wainwright & Co., LLC (“H.C.W.”) served as our exclusive placement agent in connection with the transactions consummated pursuant to the Inducement Agreement. As compensation for H.C.W. serving as our placement agent in connection with the offering, we paid H.C.W. a cash fee equal to 7.0% of the aggregate gross proceeds received upon exercise of the Existing Warrants and we issued to designees of H.C.W. warrants to purchase up to 37,143 shares of common stock, which warrants have substantially the same terms as the Series B-1 Warrants, except that they have an exercise price of $5.625 per share, which is equal to 125% of the exercise price of the New Warrants.
Current wording
H.C.W. served as our exclusive placement agent in connection with the transactions consummated pursuant to the Inducement Agreement. As compensation for H.C.W. serving as our placement agent in connection with the offering, we paid H.C.W. a cash fee equal to 7.0% of the aggregate gross proceeds received upon exercise of the Existing Warrants and we issued to designees of H.C.W. warrants to purchase up to 37,143 shares of Common Stock, which warrants have substantially the same terms as the Series B-1 Warrants, except that they have an exercise price of $5.625 per share, which is equal to 125% of the exercise price of the New Warrants.
Previous wording
During the three months ended March 31, 2026, we sold 168,690 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 $8.10 per share, resulting in total gross proceeds of approximately $1,366,535 and net proceeds of approximately $1,302,565.
Current wording
During the six months ended June 30, 2026, we sold 189,035 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 $7.71 per share, resulting in total gross proceeds of $1,458,088 and net proceeds of $1,382,670. During the three months ended June 30, 2026, we sold 20,345 shares of our Common Stock through our ATM facility with H.C.W. These sales were made at a weighted average price of $4.50 per share resulting in total gross proceeds of $91,553 and net proceeds of $80,104.
Previous wording
Research and development expenses were $0.8 million for the three months ended March 31, 2026, compared to $1.7 million for the three months ended March 31, 2025, a decrease of approximately $0.9 million, or 54%. The decrease was primarily attributable to a $0.5 million decrease in expenses associated with chemistry, manufacturing, and controls (“CMC”), a $0.3 million decrease in personnel expenses, a $0.2 million decrease in stock-based compensation, and a $0.1 million decrease in trial readiness expenses. These decreases were partially offset by a $0.2 million increase in consulting expenses and professional fees. We expect research and development expenses to increase when we commence clinical trials.
Current wording
Research and development expenses were $0.7 million for the three months ended June 30, 2026, compared to $1.1 million for the three months ended June 30, 2025, a decrease of approximately $0.4 million, or 35%. The decrease was primarily attributable to a $0.7 million decrease in expenses associated with chemistry, manufacturing, and controls (“CMC”) and a $0.2 million decrease in consulting expenses and professional fees. We expect research and development expenses to increase if we commence clinical trials.
Previous wording
General and administrative expenses were $1.7 million for the three months ended March 31, 2026, compared to $2.3 million for the three months ended March 31, 2025, a decrease of approximately $0.5 million, or 23%. The decrease was primarily driven by a $0.2 million decrease in expenses related to being a public company, a $0.1 million decrease in personnel expenses, a $0.1 million decrease in stock-based compensation, and a $0.1 million decrease in consulting expenses.
Current wording
General and administrative expenses for the six months ended June 30, 2026 and 2025 were $4.4 million and $4.9 million, respectively, representing a decrease of approximately $0.5 million, or 11%. The decrease is primarily attributed to a $0.5 million decrease in expenses related to being a public company, a $0.2 million decrease in annual Delaware franchise taxes, and a $0.1 million decrease in consulting expenses. These decreases were offset by $0.3 million increase in personnel-related expenses as a result of our former Chief Financial Officer’s severance agreement entered into in June 2026 and implemented annual pay raises for management in January 2026.
Previous wording
Since inception, we have incurred recurring 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 IPO completed in January 2023, our private placement offering completed in July 2023, our warrant inducements completed in November 2024 and April 2026, our registered direct offering and concurrent private placement completed in December 2025, and the sale of common stock through our ATM facility with H.C.W.
Current wording
Since inception, we have incurred recurring 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 IPO completed in January 2023, our private placement offering completed in July 2023, our warrant inducements completed in November 2024 and April 2026, our private placement offering in June 2026, our registered direct offering and concurrent private placement completed in December 2025, and the sale of Common Stock through our ATM facility with H.C.W.
Previous wording
As of March 31, 2026, we had cash and cash equivalents of $2.3 million. For the three months ended March 31, 2026, we reported a net loss of $2.5 million, which included $0.3 million of non-cash expenses, and cash used in operating activities of $3.0 million. On April 1, 2026, we completed a warrant inducement transaction resulting in gross proceeds of approximately $2.5 million, which we expect to partially extend our operational runway. 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. With our cash position of $3.5 million as of early May 2026, we believe we will be able to fund our operations into October 2026; however, the current cash will not be sufficient to commence and complete our planned clinical trials and no assurances can be provided and our cash runway could differ materially from our expectations based on various factors, many of which are out of our control. To meet anticipated funding needs, we plan to seek additional capital through strategic partnerships, sales under our ATM facility with H.C.W., equity offerings, debt financings, or a combination thereof. 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 wording
As of June 30, 2026, we had cash and cash equivalents of $2.4 million, which does not include the net proceeds we received on July 1, 2026 from the PIPE Transaction. For the six months ended June 30, 2026, we reported a net loss of $5.8 million, which included $0.9 million of non-cash expenses, and cash used in operating activities of $5.2 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. With our cash position of $4.2 million as of early August 2026, we believe we will be able to fund our operations through the first quarter of 2027; however, the current cash will not be sufficient to advance our product candidates to clinical trial readiness or to commence and complete any clinical trials and no assurances can be provided and our cash runway could differ materially from our expectations based on various factors, many of which are out of our control. In order to meet our expected capital needs, management is focusing on securing additional funds, which may include strategic partnerships, out-licensing agreements, non-dilutive grant funding, sales under our ATM facility with H.C.W., equity offerings, debt financings, or a combination thereof. However, there can be no assurance that we will be able to complete partnering transactions or financings on terms acceptable to us or at all or that we will be awarded any grant funding. 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.
Previous wording
During the three months ended March 31, 2026, cash used in operating activities was $3.0 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $2.2 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $0.8 million in cash primarily from a $0.7 million decrease in accrued liabilities and a $0.2 million increase in prepaid expenses, partially offset by a $0.2 million increase in accounts payable.
Current wording
During the six months ended June 30, 2026, cash used in operating activities was $5.2 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $4.8 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 $0.3 million decrease in accrued liabilities and a $0.2 million increase in prepaid expenses, partially offset by a $0.2 million increase in accounts payable.
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, 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, 2026, net cash provided by financing activities totaled $3.6 million primarily consisting of $2.3 net proceeds received from the April 2026 warrant inducement and $1.4 million received upon the sales of Common Stock in our ATM facility.
Previous wording
During the three months ended March 31, 2026, net cash provided by financing activities totaled $1.3 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 sale of Common Stock of our ATM facility and proceeds from the exercise of stock options.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
H.C. Wainwright & Co., LLC (“H.C.W.”) served as our exclusive placement agent in connection with the PIPE Transaction. As compensation for H.C.W. serving as our placement agent in connection with the PIPE Transaction, we paid H.C.W. a cash fee equal to 7.0% of the aggregate gross proceeds received and issued to designees of H.C.W unregistered warrants (the “Placement Agent Warrants”) to purchase up to an aggregate of 62,400 shares of Common Stock, equal to 6.5% of the Pre-Funded Warrant Shares sold in the PIPE Transaction. The Placement Agent Warrants have substantially the same terms as the Series C-1 Warrants, except that they are immediately exercisable for a term of five years from the Effective Date and have an exercise price of $3.9063 per share.
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025.