GLSI 10-K & 10-Q changes, risk factors and insider trading

We expect our existing cash as of December 31, 2024 will enable us to fund our operating expenses through and capital expenditure requirements for at least twelve months from the date of this Annual Report on Form 10-K; however, ourOur existing cash will not be sufficient to complete development and obtain regulatory approval for our product candidate, and we will need to raise significant additional capital to help us do so. In addition, our operating plan may change as a result of many factors currently unknown to us, and we may need additional funds sooner than planned.

As of AprilMay 11,26, 2025,2026, we had 4 full-time employees and 49 part-time employees. We will need to grow the size of our organization in order order to support our continued development and potential commercialization of our product candidate. As our development and commercialization commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales, marketing, financial and other resources may increase. Our management, personnel and systems currently in place may not be adequate to support this future growth. Future growth would impose significant added responsibilities on members of management, including:

As of AprilMay 11,26, 2025,2026, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially own approximately approximately 52%51% of our outstanding shares of common stock. As a result, these stockholders, acting together, have the ability to control the outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation or sale of all or substantially all of our assets. In addition, these stockholders, acting together, have the ability to control the management and affairs of our company. Accordingly, this concentration of ownership might harm the market price of our common stock by:

Our compliance with Section 404 of the Sarbanes-Oxley Act may require that we incur substantial accounting expense and expend significant management efforts. We may not be able to complete our evaluation, testing and any required remediation in a timely fashion. During the evaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we may be unable to assert that our internal control over financial reporting is effective. In connection with management’s assessment of internal controls over financial reporting for the quarteryear ended SeptemberDecember 30,31, 2020,2025 and all prior periods, we identified a material weakness due to inadequate segregation of duties within our accounting processes due to limited personnel and insufficient written policies and procedures for accounting, IT and financial reporting and record keeping.keeping, lack of accounting system for financial reporting/bookkeeping and software for stock awards, and insufficient policies and procedures for processing and approving employee expense reports. Although we are developing a plan to remediate the material weaknesses, we cannot assure you that we will be able to remediate such weaknesses or that there will not be new material weaknesses or significant deficiencies in our internal control over financial reporting in the future. Any failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows. If we are unable to conclude that our internal control over financial reporting is effective, we could lose investor confidence in the accuracy and completeness of our financial reports, the value of our common stock could decline, and we could be subject to sanctions or investigations by regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

Research and development expenses increased by $5,253,407,$1,740,184, or approximately 68%,11%, to $12,952,029$17,220,401 for the year ended December 31, 20242025 from $7,698,622 $15,480,217 for the year ended December 31, 2023.2024. The increase was primarily the result of increases in clinical expenses for the Phase III clinical trial and the one-time upfront vesting of 25% of an options grant to employees, management and the board of directors.trial.

We incurred net losses of $15,788,809$19,358,218 and $8,891,803$17,414,219 during the years ended December 31, 20242025 and 2023,2024, respectively, and the increase was was primarily the result of increases in clinical expenses for the Phase III clinical trialtrial. and the one-time upfront vesting of 25% of an options grant to employees, management and the board of directors. Cash was $4,091,990$6,178,021 at December 31, 2025 and $4,091,990 at December 31, 2024 and $6,989,424 at December 31, 2023 and decreasedincreased due to the following reasons:

Net cash provided by financing activities was $11,999,484 during the year ended December 31, 2025, attributable to the sale of common stock via the ATM program and the exercise of the remaining underwriter warrants. Net cash provided by financing activities was $4,369,109 during the year ended December 31, 2024, attributable to the sale of common stock via the ATM program and a private placement. There was no net cash provided by or used in financing activities during the year ended December 31, 2023.

On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control responses. There are no critical accounting policies or estimates for the year ended December 31, 2025 and 2024.

We have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS ActAct, when available to the Company, for complying with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act. As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for complying with new or revised accounting standards.

Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, when available to the Company, including, without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2025:2025.

To date, we have not generated any revenue and we have incurred net losses. Our net losses were approximately $19.4 million and $17.4 million million for the years ended December 31, 2025 and 2024, respectively and $5.7$9.6 million and $2.7$6.5 million for the threesix months ended March 31,June 30, 2026 and 2025, respectively.

Results of Operations for the Three Months Ended MarchJune 31,30, 2026 and 2025

Research and development expenses increased by $2,936,416,$142,237 or 129%,4%, to $5,207,564$3,558,714 for the three months ended MarchJune 31,30, 2026 from $2,271,148$3,416,477 for the the three months ended MarchJune 31,30, 2025. The increase was primarily the result of an increase in accounts payable for clinical trial expenses.

General and administrative expenses increased by $20,588,$110,093, or 4%,31%, to $518,190$462,931 for the three months ended MarchJune 31,30, 2026 from $497,602$352,838 for the three months ended MarchJune 31,30, 2025. The increase was primarily the result of an options grant to employees, management, and the board of directors.

We will require additional capital to meet our long-term operating requirements. We expect to raise additional capital through the sale of equity and/or debt securities; however, there is no assurance that we will be successful at raising additional capital in the future. If our plans are not achieved and/or if significant unanticipated events occur, we may have to further modify our business plan, which may require us to raise additional capital. As of MarchJune 31,30, 2026 and December 31, 2025, our principal source of liquidity was our cash, which totalledtotaled $10,505,435$8,876,353 and $6,178,021, respectively, and additional loans and accrued unreimbursed expenses from related parties. Historically, Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred stock and related party loans. Our principal uses of cash have included cash used in operations. We expect that the principal uses of cash in the future will be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

Cash Flow Activities for the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025

We incurred net losses of $5,657,137$9,605,812 and $2,744,780$6,493,420 during the threesix month periods ended MarchJune 31,30, 2026 and 2025, respectively. The increase increase was primarily the result of an options grant to employees, management, and the board of directors and an increase in accounts payable for clinical trial expenses.

Net cash used in operating activities was $4,702,498$6,642,244 for the threesix months ended MarchJune 31,30, 2026 and $1,834,454$4,067,557 for the threesix months ended June March 31,30, 2025. The increase was primarily the result of an increase in clinical trial expenses.

We did not use or generate cash from investing activities during the threesix months ended MarchJune 31,30, 2026 and 2025.

Between January 1, 2026 and MarchJune 31,30, 2026, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with with H. C. Wainwright, in which it issued and sold a total of 367,547379,762 shares of its common stock at an average offering price of $25.33 $25.36 per share for gross proceeds of $9,309,189$9,629,468 and net proceeds of $9,029,912,$9,340,576, after deducting underwriting discounts and commissions and offering expenses borne by the Company, which totalled $279,277.$288,892.

Between January 1, 2025 and MarchJune 31,30, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with H. C. Wainwright, in which it issued and sold a total of 39,918320,210 shares of its common stock at an average offering price of $12.52$9.95 per share for gross proceeds of $499,936$3,185,661 and net proceeds of $492,423,$3,100,668, after deducting underwriting discounts and commissions and offering expenses borne by the Company, which totalledtotaled $7,513.$84,993.

As of MarchJune 31,30, 2026, we did not have any material contractual obligations, other than employment and shareholder agreements and the license for GP2 from HJF.

As of MarchJune 31,30, 2026, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts amounts of expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the the significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control responses. There are no critical accounting policies or estimates for the year ended December 31, 2025 and three months ended MarchJune 31,30, 2026.