v3.26.1
Summary of Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2026
Accounting Policies [Abstract]  
Use of Estimates and Assumptions

Use of Estimates and Assumptions

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The significant areas of estimation include determining research and development accruals, the inputs in determining the fair value of equity-based awards and warrants issued, the inputs in determining present value of lease payments, and determining the fair value of marketable securities. Actual results could differ from those estimates.

 

 

Foreign Currency

Foreign Currency

 

We translate the financial statements of our Australian subsidiary, which has a functional currency of the Australian dollar, to U.S. dollars using month-end exchange rates for assets and liabilities and average exchange rates for income and expenses. Translation gains and losses are recorded in accumulated other comprehensive income (loss) as a component of stockholders’ equity. Gains and losses resulting from foreign currency transactions that are denominated in currencies other than our functional currency (U.S. dollar) are included within other income, net on the consolidated statements of operations.

 

Risks and Uncertainties

Risks and Uncertainties

 

The Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. Operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory, and other risks, including the potential risk of business failure.

 

Our marketable securities may be impacted by various risks related to interest rates, market conditions, stock market fluctuations and credit risk. Our marketable securities that are debt securities have had and may in the future have their market value fluctuate due to rises or falls in interest rates. While we believe our cash, cash equivalents and marketable securities do not contain excessive risk, we cannot provide absolute assurance that in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of cash and cash equivalents at one or more financial institutions that are federally insured. Interest bearing and non-interest-bearing accounts we hold at these banking institutions are guaranteed by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 per depositor, per FDIC-insured bank, per ownership category. From time to time, some of our cash balances held at banking institutions may be in excess of FDIC coverage.

 

We currently rely on foreign third-party manufacturers and service providers in connection with certain aspects of our clinical operations. The U.S. government and persons involved in the Trump administration have made statements and taken certain actions that have led to, and may continue to lead to, changes to U.S. and international trade policies. Although some previously imposed tariffs have recently been struck down, potential new tariffs and the potential escalation of trade disputes with foreign countries could pose a significant risk to our business and could result in higher operating expenses. U.S. policies on tariffs and international trade could also result in fluctuations in interest rates, which could have a negative impact on general economic conditions, on the industry sector in which we operate, and on our business.

 

Research and Development

Research and Development

 

Research and development costs are expensed as incurred. These expenses primarily consist of payroll, contractor expenses, research study expenses, costs for manufacturing and supplies, clinical site costs and other costs for the conduct of clinical trials, costs for technical infrastructure on the cloud for the purposes of developing the Company’s A.I. platforms, and other costs for identifying, developing, and testing drug candidates. Development costs incurred by third parties are expensed as the work is performed. Costs to acquire technologies, including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred.

 

When accruing clinical expenses, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from our service providers. However, we may be required to estimate the cost of these services based only on information available to us. If we underestimate or overestimate the cost associated with a trial or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued clinical expenses have generally approximated actual expense incurred.

 

Cash and Cash Equivalents

Cash and Cash Equivalents

 

The Company considers money market funds and other highly liquid instruments with an original maturity of 3 months or less to be cash equivalents. Cash equivalents at June 30, 2026 and December 31, 2025 were approximately $5,276,000 and $1,540,000, respectively, and are included along with cash under the caption cash and cash equivalents on the Company’s condensed consolidated balance sheets.

 

 

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets

 

Prepaid expenses and other current assets as of June 30, 2026 totaled approximately $1,098,000 and included approximately $485,000 of upfront payments for contractor fees, academic research studies and services, and subscriptions, approximately $579,000 of prepaid annual insurance fees, and approximately $34,000 of receivables from dividends and tax incentives.

 

Prepaid expenses and other current assets as of December 31, 2025 totaled approximately $684,000 and included approximately $360,000 of upfront payments for contractor fees, academic research studies and services, and subscriptions, approximately $294,000 of prepaid annual insurance fees, and approximately $30,000 of receivables from dividends and tax incentives.

 

Leases

Leases

 

The Company determines whether an arrangement contains a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liabilities, and net of current portion of operating lease liabilities on our consolidated balance sheets. Lease ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. Lease ROU assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. As the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments. The Company does not include options to extend or terminate the lease term unless it is reasonably certain that the Company will exercise any such options. Rent expense is recognized under the operating leases on a straight-line basis. The Company does not recognize right-of-use assets or lease liabilities for short-term leases, which have a lease term of twelve months or less, and instead will recognize lease payments as expense on a straight-line basis over the lease term.

 

Marketable Securities

Marketable Securities

 

The Company’s marketable securities at June 30, 2026 consist of mutual funds and common stock. The Company’s marketable securities at December 31, 2025 consist of government and agency securities, mutual funds and common stock. We classify our marketable securities as available-for-sale at the time of purchase and reevaluate such classification as of each balance sheet date. We may sell these securities at any time for use in current operations even if they have not yet reached maturity. As a result, we classify our investments, including securities with maturities beyond twelve months, as current assets in the accompanying condensed consolidated balance sheets.

 

 

Available-for-sale debt securities are recorded at fair value each reporting period. Unrealized gains and losses on available-for-sale debt securities are excluded from earnings and recorded as a separate component within accumulated other comprehensive income (loss) on the condensed consolidated balance sheets until realized. Interest is reported within interest income on the condensed consolidated statements of operations. We evaluate our available-for-sale debt securities to assess whether the amortized cost basis is in excess of estimated fair value and determine what amount of that difference, if any, is caused by expected credit losses. Allowance for credit losses are recognized as a charge in other income, net on the condensed consolidated statements of operations, and any remaining unrealized losses are included in accumulated other comprehensive income (loss) on the condensed consolidated balance sheets. The allowance for credit losses is zero at June 30, 2026 and December 31, 2025, and there were no credit losses recorded during the three and six months ended June 30, 2026 and 2025.

 

Equity securities, which are composed of mutual funds and common stock, are recorded at fair value each reporting period, with changes in fair value of these investments, as well as dividends earned, recorded within other income, net on the condensed consolidated statements of operations.

 

We determine realized gains and losses on the sale of marketable securities based on the specific identification method and record such gains and losses within other income, net on the condensed consolidated statements of operations.

 

Deferred Offering Costs

Deferred Offering Costs

 

Deferred offering costs consist of legal, accounting, underwriting, and other direct costs incurred in connection with the Company’s ATM financing activities. These costs are capitalized as incurred and recognized as a reduction of additional paid-in capital in the consolidated statements of stockholders’ equity when shares are issued. At June 30, 2026 and December 31, 2025, the Company had approximately $55,000 and $88,000, respectively, of deferred offering costs related to the ATM. At June 30, 2026, stock issuances of up to $13,905,453 remained available under the ATM, subject to certain limits that may vary from time to time. If the Company terminates the ATM or deems it probable that the full amount available will not be utilized, the related deferred offering costs will be expensed and recognized in general and administrative expenses in the condensed consolidated statements of operations. During the six months ended June 30, 2026, the Company expensed approximately $33,000 of deferred offering costs. There were no deferred offering costs expensed during the three months ended June 30, 2026 or during the three and six months ended June 30, 2025.

 

Warrant Liability

Warrant Liability

 

The Company has issued warrants that are accounted for as liabilities in accordance with ASC 815. These common stock purchase warrants do not trade in an active securities market, and as such, the Company estimates the fair value of these warrants using a combination of Black Scholes and Monte Carlo pricing models with the assumptions as follows: The risk-free interest rate for periods within the contractual life of the warrant is based on the U.S. Treasury yield curve. The expected life of the warrants is based upon the contractual life of the warrants. The volatility is estimated based on historical volatility of the Company’s stock using the closing price of its common shares.

 

The Company computes the fair value of the warrant liability at issuance and records the initial valuation as a reduction in proceeds from the offering. The warrants are subsequently remeasured at each reporting period until they are either exercised or expired, and the change in the fair value is recorded as non-cash expense or non-cash income. The key component in the value of the warrant liability is the Company’s stock price, which is subject to significant fluctuation and is not under the Company’s control. The resulting effect on the Company’s net loss is therefore subject to significant fluctuation and will continue to be so until the warrants are exercised, amended or expire. Assuming all other fair value inputs remain constant, the Company will record non-cash expense when the stock price increases and non-cash income when the stock price decreases.

 

Stock-based Compensation

Stock-based Compensation

 

Stock-based awards have been accounted for as required by ASC 718 Compensation - Stock Compensation. Under ASC 718, awards are valued at fair value on the date of grant, and that fair value is recognized over the requisite service period. Forfeitures are accounted for as they occur.

 

 

New Accounting Pronouncements Not Yet Adopted

New Accounting Pronouncements Not Yet Adopted

 

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, requiring public business entities to provide disaggregated disclosures of relevant income statement expenses. The amendments aim to improve financial reporting by enhancing transparency in the notes to financial statements, specifically regarding expense categories. The amendments in this update are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. The Company is assessing the effect of this update on its consolidated financial statements and related disclosures.