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

Investing in our securities involves a high degree of risk. You should carefully consider the following risks and other information included or incorporated by reference in this Annual Report in evaluating our company and our common stock. Any of the following risks could materially and adversely affect our results of operations, our financial condition and the market price of our common stock. Although the risk factors are grouped by general category, many of the risks described in a given category relate to multiple categories. The risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition. These disclosures reflect our beliefs and opinions as to factors that could materially and adversely affect us and our securities in the future. References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future. See “Cautionary StatementNote Regarding Forward-Looking Statements” in this Annual Report. If any of these risks actually materialize, our business, prospects, financial condition and results of operations could be seriously harmed. This could cause the trading price of our common stock to decline, resulting in a loss of all or part of your investment.

We are focused on product development, and we have not generated any significant revenues to date. We have incurred losses in each year of our operations and we expect to continue to incur operating losses for the foreseeable future. Since our inception, we have incurred operating losses which have adversely affected, and are likely to continue to adversely affect, our working capital, total assets and shareholders’stockholders’ equity. In addition, the impact of these events and conditions on our liquidity raise substantial doubt about our ability to continue as a going concern.

Product candidates employing our technology are subject to extensive and rigorous domestic government regulation including regulation by the FDA, the Centers for Medicare and Medicaid Services (“CMS”),CMS, other divisions of the United States Department of Health and Human Services (“HHS”), the United States Department of Justice (“DOJ”), state and local governments and their respective foreign equivalents. The FDA and comparable foreign regulatory authorities regulate the research, development, preclinical studies and clinical trials, manufacture, safety, effectiveness, recordkeeping, reporting, labeling, storage, approval, advertising, promotion, sale, distribution, import and export of biopharmaceutical products. If products employing our technologies are marketed abroad, they will also be subject to extensive regulation by foreign governments, whether they have obtained the FDA’s or comparable foreign regulatory authorities’ approval for a given product and its uses. Such foreign regulation may be equally or more demanding than corresponding U.S. regulation.

As part of our business strategy, we may seek Orphan Drug Designation for one or more of our product candidates which may be unsuccessful. Regulatory authorities in some jurisdictions, including the United States and European countries, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the U.S. or a patient population greater than 200,000 in the U.S. where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the U.S. In the U.S., Orphan Drug Designation entitles a party to financial incentives such as a tax credit. Opportunities for grant funding toward clinical trial costs may also be available for clinical trials of drugs for rare diseases, regardless of whether the drugs are designated for the orphan use. In addition, if a product that has Orphan Drug Designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity which means that the FDA may not approve any other applications to market the same product for the same indication for seven years, except in limited circumstances.

Following completion of clinical trials, the results are evaluated and, depending on the outcome, aan New Drug Application (“NDA”) is submitted to the FDA to obtain the FDA’s approval of the product and authorization to commence commercial marketing. In responding to an NDA, the FDA may require additional testing or information, may require that the product labeling be modified, may impose post-approval study and other commitments or reporting requirements or other restrictions on product distribution, or may deny the application. The FDA has established performance goals for review of NDAs: six (6) months for priority applications and ten (10) months for standard applications. However, the FDA is not required to complete its review within these time periods. The timing of final review by the FDA and action varies greatly but can take years in some cases and may involve the input of an FDA advisory committee of outside experts. Product sales in the U.S. may commence only when an NDA is approved. Comparable procedures and limitations are applicable in the EU and in other jurisdictions.

To develop and bring our product candidates to market, we must commit substantial resources to costly and time-consuming research, preclinical studies and clinical trials and marketing activities. Until such time, if ever, as we can generate substantial product revenue, we expect to seek additional funding to meet our operational needs and capital requirements. While we believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the thirdfirst quarter of 2025,2027, we have based this estimate on assumptions that may prove to be wrong and we could exhaust our available capital resources sooner than we expect, including if our business or operations change in a manner that consumes available resources more rapidly than we anticipate. Our requirements for additional capital will depend on many factors including:

Our business and operations may be adversely affected by pandemics or epidemics, including business interruptions caused by travel restrictions, quarantines, “stay-at-home” and "shelter-in-place" orders, shutdowns requested or mandated by governmental authorities or staffing shortages while employees quarantine as a result of exposure to or transmission of the virus. In addition, health epidemics or pandemics could cause significant disruption in the operations of third-party manufacturers, CROs and other parties upon whom we rely. For example, the COVID-19 pandemic and the resulting post-pandemic environment presented a substantial public health and economic challenge around the world and affected employees, patients, communities and business operations as well as the global economy and financial markets. It also impacted clinical site activation and patient enrollment. Clinical trial sites experienced limited capacity and staffing shortages, partially due to personnel having been reassigned during the pandemic, resulting in a backlog of patient enrollment and delayed site initiations across the industry. Our inability to successfully recruit and retain patients and principal investigators and site staff in these circumstances could adversely impact our expected future clinical trial operations.

In addition, the U.S. Patent and Trademark Office (“PTO”) and patent offices in other jurisdictions have often required that patent applications concerning pharmaceutical and/or biotechnology-related inventions be limited or narrowed substantially to cover only the innovations specifically exemplified in the patent application, thereby limiting the scope of protection against competitive challenges. Thus, even if we or our licensors are able to obtain patents, the patents may be substantially narrower than anticipated which could deprive us of rights necessary for the successful commercialization of our product candidates.

We have licensed certain rights, assets and technology related to the Magellan™ platform from Minoryx and we believe that they owned all such rights prior to our license. Although, to our knowledge, no third party has asserted a claim of infringement or other claim against us, others may hold or claim to hold proprietary or other rights that could prevent our Magellan™ platform from being developed or marketed. Any legal action against us claiming damages and seeking to enjoin commercial activities relating to our Magellan™ platform or our processes could subject us to potential liability for damages and require us to obtain a license to continue to manufacture or market any future product candidates based upon the Magellan™ platform. We may not prevail in any such actions and any license required under any of these patents may not be made available on commercially acceptable terms, if at all. In addition, we may not be able to redesign any future product candidates or processes to avoid infringement, if necessary. Accordingly, an adverse determination in a judicial or administrative proceeding or the failure to obtain necessary licenses could prevent us from developing and commercializing our future product candidates which could harm our business, financial condition and operating results.

We believe that there are a variety of manufacturers that we may be able to retain to produce these products. However, we may be in competition with other companies for access to these manufacturers’ facilities and may be subject to delays in manufacture if the manufacturers give other clients higher priority than they give to us. If we are unable to secure and maintain third-party manufacturing capacity, the development and sales of our products and our financial performance may be materially affected. In addition, once we retain a manufacturing source, if our manufacturers do not perform in a satisfactory manner, we may not be able to develop or commercialize potential products as planned. Certain specialized manufacturers are expected to provide us with modified and unmodified pharmaceutical compounds, including finished products, for use in our preclinical studies and clinical trials. Some of these materials are available from only one supplier or vendor. Any interruption in or termination of service by such sole source suppliers could result in a delay or interruption in manufacturing until we locate an alternative source of supply. Any delay or interruption in our future supply chain and manufacturing operations (or failure to locate a suitable replacement for such suppliers) as a result of pandemics or epidemics, global geopolitical conflicts or broader global supply chain disruptions, may affect their ability to deliver products to us in a timely manner and, could materially adversely affect our business, prospects, or results of operations. For example, supply chain issues occurred as a result of the COVID-19 pandemic and may continue to occur due to the war between Ukraine and Russia, the recent conflict betweenin HamasIran and Israelthe Middle East, and any sanctions resulting therefrom, and global geopolitical tension, including as a result of impacts on energy availability and prices and natural materials availability and prices. We also have a third-party manufacturer in China, which may be impacted by heightened tensions between the United States and China. If we fail to contract for manufacturing on acceptable terms or if third-party manufacturers do not perform as we expect, our development programs could be materially adversely affected. This may result in delays in filing for and receiving FDA or comparable foreign regulatory authority approval for one or more of our products or prevent such approval entirely. Any such delays or failures to obtain regulatory approval could cause our prospects to suffer significantly.

One of our primary manufacturers and suppliers, WuXi AppTec (“WuXi”), is located in China and the subject of increased U.S. government scrutiny. Trade tensions and conflicts between the United States and Chinaother countries, particularly China, have been escalating in recent years and, as such, we are exposed to the possibility of product and material supply disruption and increased costs and expenses in the event of changes to the laws, rules, regulations and policies of the governments of the United StatesStates, orChina China,and other countries, or due to geopolitical unrest and unstable economic conditions. We currently rely on partners based in China.

The U.S. government has recently made statements and taken certain actions that may lead to potential changes to U.S. and international trade policies, including imposing several rounds of tariffs and export control restrictions affecting certain products manufactured in China. Increased focus on relations with China has included U.S. legislative proposals, such asincludes the proposedrecently enacted BIOSECURE Act. The BIOSECURE Act, which has been passed by the U.S. House of Representatives and is pending before the U.S. Senate. If enacted, the BIOSECURE Act would, among other things, prohibitprohibits U.S. federal agencies from entering into or renewing any contract with any entity that uses biotechnology equipment or services produced or provided by a “biotechnology company of concern” (“BCC”) to perform that contract with the government. AlthoughThe theU.S. proposedOffice BIOSECUREof Act has not been enactedManagement and thusBudget (“OMB”) is subjectrequired to changelist through the legislative process, a version of the BIOSECURE Act passedBCCs by theDecember U.S. House of Representatives defines a “biotechnology company of concern” to include WuXi.2026. If adopted, the BIOSECURE Act could cause us to seek to exit some or allone of our arrangementsChinese withpartners WuXiis (ornamed anyas othera China-basedBCC, service provider determined to be “biotechnology companies of concern”) and accelerate the transition of these services to alternative companies or continue to engage redundant suppliers for the U.S. market. Additionally, the legislation could adversely impact WuXi’s operations or financial position which, in turn, could impact itsour ability to perform underdevelop our agreementsproduct with it. Our reliance on Chinese-based contract research organizations, such as WuXi,candidates may alsobe causeadversely us to face additional risks due to geopolitical tensions between the U.S. and China and related legal and regulatory restrictions and requirements, including measures directly affecting WuXi.affected.

Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may increase the cost of manufacturing our product candidates and platform materials, affect the demand for our drug products (if and once approved), the competitive position of our product candidates, and import or export of raw materials and finished product candidate used in our and our collaborators’ preclinical studies and clinical trials, particularly with respect to any product candidates and materials that we import from China, including pursuant to our arrangements with WuXi.China. If any new tariffs, export controls, legislation and/or regulations are implemented, or if existing trade agreements are renegotiated or, in particular, if either the U.S. or Chinese government takes retaliatory trade actions due to the recent trade tension, such changes could have an adverse effect on our business, financial condition and results of operations. Any negative impact of the ability of our third party collaborators to deliver the materials we require to conduct our clinical operations due to political actions, supply chain disruptions or otherwise, may have a material adverse impact on our results of operations or financial condition.

The global credit and financial markets have recently experienced extreme volatility and disruptions including severely diminished liquidity and credit availability, disruptions in access to bank deposits and lending commitments due to bank failures, declines in economic growth, increases in unemployment rates, supply chain disruptions, heightened interest rates and inflation, stock volatility and uncertainty about economic stability. Such conditions may continue or worsen in the future. The financial markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict including Russia’s invasion of Ukraine and the recent conflict betweenin HamasIran and Israel,the Middle East, terrorism or other geopolitical events. Sanctions imposed by the U.S. and other countries in response to such conflicts, including sanctions imposed in connection with the war in Ukraine and the conflict between Hamas and Israel,Ukraine, the effect of tariffs and/or any resulting trade wars, increasing interest rates, or other factors may also adversely impact the financial markets and the global economy and any economic countermeasures by affected countries and others could exacerbate market and economic instability. For example, in late 2024 and early 2025, the United States, Canada, China, and the European Union each announced either new tariffs, non-tariff barriers, or export controls. Any of these risks, ensuing retaliation, or the further deterioration of trade relations between countries could have an adverse impact on our financial condition and results of operations. Additional tariffs or further retaliatory trade measures taken by China or other countries in response could affect the demand for any of our products, impact the competitive position of our products, prevent us from being able to sell products in certain countries or otherwise adversely impact our results of operations. Growing tensions, protectionist trade policies, and tariffs may also lead to a fragmentation of the global economy, a general reduction of international trade in goods and services, and a reduction in the integration of financial markets, any of which could materially and adversely affect our financial condition, or prospects. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur.

We expect that theseexisting and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and additional downward pressure on the price that we receive for any approved drug. Any reduction in reimbursement from Medicare or other comparable foreign programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our drugs.

Cyberattacks, malicious internet-based activity, online and offline fraud, and other similar activities are prevalent and continue to increase. These threats are becoming increasingly difficult to detect. These threats come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized crime threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors. Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, including the war in Ukraine and the recent conflict betweenin HamasIran and Israel,the Middle East, we and the third parties upon which we rely may be vulnerable to a heightened risk of these attacks, including cyber-attacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our goods and services.

We incur and will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.

New tax laws, statutes, rules, regulations, or ordinances could be enacted at any time.time, and existing tax laws, statutes, rules, regulations, or ordinances could be interpreted differently, changed, repealed, or modified at any time, possibly with retroactive effect. Tax legislation continues to evolve globally, creating uncertainty in the global economy. For instance, the IRAInflation Reduction Act imposes, among other rules, a 15% minimum tax on the book income of certain large corporations and a 1% excise tax on certain corporate stock repurchases. Further,In existingaddition, on July 4, 2025, legislation commonly referred to as the One Big Beautiful Bill Act (the "2025 U.S. Tax Act") was signed into law, which includes significant provisions such as tax laws,cut statutes,extensions rules,and regulations,modifications to the international tax framework. While we do not anticipate the 2025 U.S. Tax Act to have a material impact to our financial condition, results of operations, cash flows, or ordinanceseffective couldtax berate, interpretedwe differently,continue changed,to repealed,evaluate orthe modifiedimpact atof anythe time.legislative Anychanges suchas enactment,additional interpretation,guidance change,becomes repeal,available. orUncertainty modificationremains couldregarding adverselytiming affectand us,interpretation possiblyby withthe retroactivetax effect.authorities in the affected jurisdictions. In particular, changes in corporate tax rates, the realization of our net deferred tax assets, the taxation of foreign earnings, and the deductibility of expenses under the Tax Cuts and Jobs Act, as amended by the Coronavirus Aid, Relief, and Economic Security Act or any future tax reform legislation, could have a material impact on the value of our deferred tax assets, result in significant one-time charges, and increase our future tax expenses. Future tax reform and legislative changes could have an adverse impact on our future effective tax rate, tax liabilities, and cash tax.

Our amended and restated certificate of incorporation (the “Amended Charter”) gives our board of directors the ability to designate and issue preferred stock in one or more series. As a result, the board of directors may, without stockholder approval, issue preferred stock with voting, dividend, conversion, liquidation or other rights which could adversely affect the relative voting power and equity interest of the holders of common stock. Preferred stock, which could be issued with the right to more than one vote per share, could have the effect of discouraging, delaying or preventing a change of control of us. The possible impact on takeover attempts could adversely affect the price of our securities. Although we have no present intention to designate any series, or issue any shares, of preferred stock, other than pursuant to the IPO, we may do so in the future.

Our clinical stage product candidate, GT-02287, is being developed for the treatment of Parkinson’s disease with and without GBA1 mutations. We have generated an extensive preclinical data package providing evidence of the mechanism of action, in vivo pharmacology, and safety of GT-02287. In preclinical models of GBA1 Parkinson’s disease, GT-02287 has been shown to restore glucocerebrosidase, or GCase, function in the lysosome, reduce toxic lipid substrates and toxic forms of alpha-synuclein, reduce endoplasmic reticulum stress, improve mitochondrial health and overall survival of dopaminergic neurons, increasing dopamine levels, restoring locomotor and cognitive function, and reducing plasma-based neurodegeneration maker, neurofilament light chain (NfL), back to the level of control animals. In a Phase 1 first-in-human study (n = 72), GT-02287 was safe and generally well tolerated up to and including the highest planned dose level, enabling further development in GBA1 Parkinson’s patients. Additionally, administration of GT-02287 was associated with a mean increase in GCase activity of 53% among healthy volunteers at doses that were predicted to be in the therapeutic range based on preclinical models and will be carried forward in later stage trials of GT-02287. The good safety and tolerability profile and the observed range of plasma exposure levels achieved after oral administration further bolster GT-02287’s best in-class potential.

We continue to monitor the impacts on our operations and access to financing, global and worsening macroeconomic conditions, such as the war in Ukraine, the Hamas-Israelrecent conflict,conflict in Iran and the Middle East, global geopolitical tension, exchange rate fluctuations, supply chain disruptions, liquidity concerns and increases in commodity, energy and fuel prices.

Since our inception in 2017, we have devoted substantially all of our resources to identify and develop next-generation brain-penetrant allosteric small molecules for the treatment of devastating diseases with high-unmet medical needs using our Magellan™ platform. As of December 31, 2025 our efforts have led to the advancement of our lead clinical candidate, GT-02287 for the treatment of Parkinson’s disease through Phase 1 testing and preparing to initiate Phase 2 clinical testing during the third quarter of 2026. Our operations have consisted primarily of organizing and staffing the Company, expanding its operations, securing financing, performing research, conducting preclinical studies and acquiring, developing and securing our in-licensed technology. To date, we do not have any product candidates approved for sale and have not generated any revenue from product sales, and as a result, we face risks associated with early-stage biotechnology companies whose product candidates are in development. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. We expect our research and development expenses to remain significant, and to increase to support progress in our research and development activities. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities. These efforts require significant amounts of additional capital for us to complete our research and development, achieve our research and development objectives, defend our intellectual property rights, and recruit and retain skilled personnel, and key members of management. Even if our product development efforts are successful, it is uncertain when, if ever, we will realize significant revenue from product sales.

In NovemberJuly 2023,2025, we completed the public offering of 2.5 million4,501,640 shares of our common stock and warrants to purchase 1.3 million2,250,820 shares of our common stock. The warrants havewere an exercise price of $2.75 per shareoffered and were sold at thea rate of one warrant for every two shares of common stock purchased in the public offering.purchased. The public offering price for each set of two shares of common stock and accompanying warrant to purchase one share of common stock was $4.01$3.11, (withyielding an effective price of $2.00$1.55 per share and $0.01 per warrant. Each warrant). In a private placement that was completed concurrently with the public offering we also issued to accredited investors 2.5 million of shares of our common stock (or pre-funded warrants in lieu thereof) and private warrants to purchase 2.5 million shares of our common stock withhas an exercise price of $2.75 per share. The private offering price$1.65 per share of common stock and accompanyingwas warrantimmediately inexercisable on the private placement was $2.00 per setdate of securities sold privately.issuance. The public offering and the concurrent private placement resulted in combined gross proceeds to us of $10.1$7.0 million, which included $1.2$1.0 million ofin underwritingoffering commissions,expenses, placementsuch agent’sas underwriter fees and otherlegal, expensesaudit, connectedand withadvisory costs, for net proceeds to us of $6.0 million. As of December 31, 2025, 1,146,821 public warrants were exercised resulting in the financing round. Additionally, a totalissuance of 353,1561,146,821 warrants to purchase an equal amountshares of our common stock atand annet exerciseproceeds priceto us of $2.75$1.9 per share were granted to the underwriter and the placement agent associated with the offerings as consideration for the services provided, which provide for cash-less exercise.million.

AsFollowing partcompletion of the July 2025 public offering in June 2024, we grantedoffering, the underwriter anexercised its over-allotment option to purchase up to an additional 1,222,222675,246 shares of ourcommon stock, and warrants to purchase 337,623 shares of common stock, at the public offering price of $1.35, less underwriting discounts and commissions. In July 2024, the underwriter partially exercised the over-allotment option and purchased an additional 337,076 shares of our common stock at the offering price mentioned above. The exercise of the over-allotment optionwhich resulted in additional gross proceeds to us of $0.46$1.1 million, which included $42$0.1 thousandmillion in offering expenses, such as underwriter fees, for net proceeds to us of underwriting$1.0 commissionsmillion. andIn other expenses connectedconnection with the exercisepublic ofoffering, we issued the option. We also issued 593,965underwriter warrants to purchase an362,382 equal amountshares of our common stock at an exercise price of $1.6875$1.94 per share to the underwriter as consideration for the services provided,provided. whichThe underwriter warrants provide for cash-lesscashless exercise.

In the third quarter ofSeptember 2024, we entered into an Equity Distribution Agreement (the “"Distribution Agreement”) with Oppenheimer & Co. Inc., serving as agent (“"Oppenheimer”) with respect to an at-the-market (“"ATM”) offering program (the “"2024 ATM Program”). Under the 2024 ATM Program we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million. We will pay Oppenheimer a commission equal to 3.0% of the gross sales proceeds of any shares sold through Oppenheimer under the Distribution Agreement. DuringFor the year ended December 31, 2024,2025, we sold an aggregate of 1,597,1286,850,679 shares of our common stock at a weightedan average selling price of $1.97$2.74 per share under the 2024 ATM Program, raising gross proceeds of $3.1$18.8 million, which included $0.2$0.7 million inof sales commissions and other offering expenses.expenses for net proceeds to us of $18.1 million. As of December 31, 2025, we have sold an aggregate of 8,447,807 shares of common stock at an average selling price of $2.60 per share under the 2024 ATM Program, raising gross proceeds of $21.9 million, which included $0.9 million of sales and commissions and other offering expenses for net proceeds to us of $21.0 million.

From inception through December 31, 2024,2025, we have raised an aggregate of $89$120 million of gross proceeds through equity financing,financings, including the issuance of convertible preferred stock, our initial public offering, secondary offerings and previous sales under our ATM programs. We have outstanding warrants for 5.8 million shares of our common stock at a weighted-average exercise price per share of $2.31 through December 31, 2025 related to public and private offerings. Of the 5.8 million outstanding warrants, 5.4 million warrants are exercisable at a weighted-average exercise price per share of $2.34 as of December 31, 2025.

As of December 31, 2024,2025, we had cash and cash equivalents of $10.4$20.8 million. We have incurred recurring losses and negative cash flows from operations since inception and as of December 31, 20242025 and December 31, 2023,2024, had an accumulated deficit of $81.2$101.4 million and $60.8$81.2 million, respectively. We anticipate incurring additional losses until such time, if ever, that we can generate sales of our product candidates currently in development. We have not generated any product revenues and have not achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and, if achieved, could be sustained on a continuing basis. In addition, we will need significant additional financing to fund our operations and to develop our product candidates. Our ability to continue operations after our current cash resources are exhausted depends on our ability to obtain additional financing or to achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in direction of our research and development programs, competitive and technical advances, patent developments, regulatory changes or other developments. If adequate additional funds are not available when required, or if we are unsuccessful in entering into partnership agreements for further development of our pipeline, management may need to curtail our development efforts and planned operations to conserve cash.

As of December 31, 20242025 and December 31, 2023,2024, we had an accumulated deficit of $81.2$101.4 million and $60.8$81.2 million, respectively, and as of December 31, 2024,2025, we had cash and cash equivalents of $10.4$20.8 million. During the year ended December 31, 2024,2025, we incurred net losses of $20.4$20.2 million and negative cash flows from operations of $18.9$18.5 million. Our current operating plan indicates that we will continue to incur losses from operations and generate negative cash flows from operating activities. Our projected cash outflows for the upcoming periods raise substantial doubt about our ability to continue as a going concern for at least 12 months from the issuance of the financial statements included elsewhere in this Annual Report. We will need to raise additional capital to fund continued operations beyond the thirdfirst quarter of 2025.2027. We plan to address our liquidity needs by taking steps to improve our operations and cash position, including identifying access to future capital and potential cost-reduction measures.

Until such time, if ever, as we can generate substantial product revenues to support our business and corporate strategy, we expect to finance our cash needs through a combination of public and private equity offerings, including an at-the-market offering,offerings, debt financings, government or private party grants, collaborations, strategic alliances and licensing arrangements. We may not be able to obtain financing on acceptable terms, or at all, and we may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all. The terms of any financing may adversely affect our holdings or the rights of our stockholders. If we are unable to obtain funding, we could be required to delay, limit, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, or grant rights to develop, sell and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves, which could adversely affect our business prospects.

TheUncertain macroeconomic conditions, including the risk of inflation, fluctuating interest rates, changing international trade and import policies, potential impact of tariffs, instability in the financial system, the war in Ukraine, the conflict between Hamas and Israel, global geopolitical tensions,tension, andas thewell postas COVID-19rising environmenthealthcare costs continue to have unpredictable impacts on global societies, economies, financial markets, and business practices. Recently worsening global macroeconomic conditions, liquidity concerns at and failures of banks and other financial institutions, volatilityVolatility in the capital markets, and related market uncertaintyuncertainty, may impact our ability to obtain additional financing when needed on favorable terms or at all.

We have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future, if at all. If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval and successfully commercialize them, we will not generate revenues in the future. Historically, we have received limited collaboration revenue pursuant to a collaboration agreement with Zentalis Pharmaceuticals which concluded in the year ended December 31, 2023.

We recognize research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our financial statements as prepaid or accrued research and development expenses. We anticipate that our research and development expenses will increase substantially in future periods to support progress in our research and development activities, including the progressingprogression of the clinical trials for product candidates we are developing. These increases will likely also result from expanded infrastructure and increased insurance costs. Such expenses are offset by contributions from research grants, which are recorded as a reduction to research and development expenses when we have reasonable assurance of collection and based on our best estimate of the periods in which the related expenditures are incurred and activities performed.

Our primary research and development focus since inception has been the application of our Magellan™ platform to various indications and targets, and more recently the development of our clinical stage lead product candidate GT-02287 for the treatment of Parkinson’s disease and other neurodegenerative diseases. As of December 31, 2025 our efforts have led to the advancement of GT-02287 through Phase 1 testing and preparing to initiate Phase 2 clinical testing during third quarter of 2026.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will continue tomay increase in the foreseeable future as we (i) increase personnel costs, including stock-based compensation, (ii) continue preclinical development of our lead compounds, (iii) progress our clinical trials for certain product candidates, (iv) continue to discover and develop additional product candidates, and (v) pursue later stages of clinical development of product candidates.

General and administrative expenses consist primarily of salaries, bonusbonuses and other related costs, including share-basedstock-based compensation, for personnel in our executive, finance, corporate and business development and administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters, professional fees for accounting, auditing, tax and consulting services, insurance costs, travel expenses, and facility-related expenses, and other operating costs.

The following table summarizes our results of operations for the years ended December 31, 20242025 and December 31, 2023.2024.

Research and development expenses decreased by $0.7$0.6 million to $10.2 million for the year ended December 31, 2025, as compared to $10.8 million for the year ended December 31, 2024, as compared to $11.5 million for the year ended December 31, 2023.2024. The decrease in research and development expenses was primarily related to higher recognitionoptimization of researchour grantpipeline incomecosts. principallyThe compriseddecrease of a tax credit for eligible research and development expenses in Australia. These increases werewas partially offset by higherunfavorable costsforeign associatedexchange withcurrency translation as the ClinicalSwiss Phasefranc 1strengthened trial of our lead program compound GT-02287 foragainst the treatmentU.S. of Parkinson’s disease.dollar.

General and administrative expenses decreased by $1.2$1.1 million to $8.5 million for the year ended December 31, 2025 from $9.6 million for the year ended December 31, 2024 from $10.8 million for the year ended December 31, 2023.2024. The decrease in general and administrative expenses was primarily attributable to lower personnel and stock-based compensation costs.and lower legal fees. The decrease was partially offset by higher personnel costs and unfavorable foreign exchange currency translation as the Swiss franc strengthened against the U.S. dollar.

Foreign exchange loss, net decreasedincreased by $0.5$953 millionthousand to a loss of $834 thousand for the year ended December 31, 2025 from a gain of $0.1$119 millionthousand for the year ended December 31, 2024 fromdue a loss of $0.4 million forto the year ended December 31, 2023. The decrease was mainly attributable to favorableunfavorable foreign exchange currency translationexchange as the Swiss franc weakenedstrengthened against the U.S. dollar.

Income taxes arewere $537$0.9 thousandmillion and $79$0.5 thousandmillion for the years ended December 31, 20242025 and 2023,2024, respectively. The increase was mainly attributable to higher income taxes payable in Australia.

As of December 31, 20242025 and December 31, 2023,2024, we had $20.8 million and $10.4 million in cash and cash equivalents and $16.8 million in cash, cash equivalents and marketable securities,equivalents, respectively, and an accumulated deficit of $81.2$101.4 million and $60.8$81.2 million, respectively. We had indebtedness of $0.4 million and $0.6 million as of December 31, 20242025 and 2024. For the year ended December 31, 2023,2025, respectively.we raised $7.0 million in net proceeds from our July 2025 public offering, $3.2 million in net proceeds from the exercise of warrants, and $18.1 million in net proceeds under the 2024 ATM Program. Our cash and cash equivalents available at December 31, 20242025 are expected to be sufficient to fund our anticipated operating and capital requirements into the thirdfirst quarter of 20252027 and will not be sufficient to finance our operations for one year from the issuance of the financial statements included in this Annual Report. Therefore, we have reported that there is substantial doubt about our ability to continue as a going concern. Please refer to the discussion above titled “Going Concern”.

During the years ended December 31, 20242025 and 2023,2024, we used $18.5 million and $18.9 millionmillion, respectively of cash in operating activities, primarily to fund our operations related to the development of our pipeline and product candidates as well as related general and administrative support activities.

During the year ended December 31, 2024,2025, cash provided by financing activities was $13.0$28.4 million primarilywhich relatedconsisted toof the following: $10.3$7.4 million provided byof net proceeds from the issuance of shares and warrants in the July 2025 public offering, $3.0$18.1 million provided byof net proceeds from issurancethe issuance of shares inpursuant to the 2024 ATM offering,Program, $0.2$3.5 million provided by the exercise of stock options and public warrants, partially offset by $0.3$0.4 million payment of offering costs and $0.1 million repayment of long-term debt.

During the year ended December 31, 2023,2024, cash provided by financing activities was $12.6$13.0 million mainlyprimarily related to the following: $10.3 million provided by net proceeds from the publicissuance offeringof shares and warrants in the concurrentpublic privateoffering, placement$3.0 formillion $9.2provided million, and theby net proceeds relatedfrom issuance of shares pursuant to the issurance2024 ATM Program, $0.2 million provided by the exercise of sharesstock inoptions theand ATMpublic warrants, partially offset by $0.3 million payment of offering costs and $0.1 million repayment of $3.5long-term million.debt.

Our management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these consolidated financial statements and related disclosures requiresrequire us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, defined benefit pension liability, share-basedstock-based compensation, warrants, recognition of research grants and the going concern assessment. Our actual results may differ from these estimates under different assumptions or conditions. During the year ended December 31, 2024,2025, there were no material changes to our critical accounting policies. While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements included elsewhere in this Annual Report, we believe the following accounting policies are the most critical to the judgments and estimates used in the preparation of our consolidated financial statements.

We operate defined benefit pension plans and defined contribution pension plans in accordance with local regulations and practices. These plans are funded by regular contributions made by the employer and the employees to a third-party. For defined benefit pension plans, the liability recognized in the balance sheets is the present value of the defined benefit obligation at the balance sheet date less the fair value of plan assets. The overfunded or underfunded status of the defined benefit plans is calculated as the difference between plan assets and the projected benefit obligations. Estimates are used in determining the assumptions incorporated in the calculation of the pension obligations, which isare supported by input from independent actuaries. Actuarial gains and losses arising from experience adjustments and changes in actuarial assumptions are recognized in “Accumulated Other Comprehensive Income (Loss)” in the Consolidated Statements of Changes in Stockholders’ Equity and are charged or credited to income over the employees’ expected average remaining working lives. The measurement date used for our employee defined benefit plan is December 31st.

Share-basedStock-based compensation

We recognize compensation costs related to share-basedstock-based compensation awards granted to employees, consultants, and directors based on the estimated fair value of the awards as of the grant date. We estimate the grant date fair value and the resulting share-basedstock-based compensation using the Black-Scholes option-pricing model for stock option awards. The grant date fair value of the stock option awards is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. We estimate the fair value of stock options using the Black-Scholes option-pricing model, which requires assumptions, including volatility, the expected term of exercise, the risk free interest rate for a period that approximates the expected term of exercise, and our expected dividend yield. Certain assumptions used in our Black-Scholes option-pricing model represent management’s best estimates and involve a number of assumptions and the application of management’s judgment, as they are inherently subjective. We recognize expenses related to Restricted Stock Units (or RSUs) based on their fair market value, determined as the closing price on the Nasdaq of our common stock as of the grant date, on a straight-line basis over the requisite service period. For restricted stock units with market or performance based vesting conditions (or PRSUs), the fair value at grant date is calculated using an option-pricing model (Monte Carlo Simulation) or based on management’s assessment of the likelihood of occurrence of the underlying performance.

At each reporting period, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The assessment over going concern is based on management’s most updated budget and forecast and does not take into consideration estimated future cash inflows that are not certain as of the date of preparation of the financial statements. Please refer to the discussion above titled “Going Concern”.

Our clinical stage product candidate, GT-02287, is being developed for the treatment of Parkinson’s disease with and without GBA1 mutations. Following the recent acceptance of "rexaceract" as the International Nonproprietary Name (INN) for GT-02287, all references made to GT-02287 within the program will transition to this established nonproprietary name. We have generated an extensive preclinical data package providing evidence of the mechanism of action, in vivo pharmacology, and safety of GT-02287.rexaceract. In preclinical models of GBA1 Parkinson’s disease, GT-02287rexaceract has been shown to restore glucocerebrosidase, or GCase, function in the lysosome, reduce toxic lipid substrates and toxic forms of alpha-synuclein, reduce endoplasmic reticulum stress, improve mitochondrial health and overall survival of dopaminergic neurons, increasing dopamine levels, restoring locomotor and cognitive function, and reducing plasma-based neurodegeneration marker, neurofilament light chain (NfL), back to the level of control animals.

As of MarchJune 31,30, 2026, two clinical studies of GT-02287rexaceract have been completed, and one is ongoing. GT-02287Rexaceract was initially characterized in a first-in-human Phase 1a clinical study to assess the safety, tolerability, pharmacokinetics, and food effect of GT-02287rexaceract in healthy participants. The study design included a single ascending dose part during which the study participants received one dose of GT-02287rexaceract at different dose levels, and a multiple ascending dose part during which the study participants received one daily dose of GT-02287rexaceract for 14 days at different dose levels. The Phase 1a study started in September 2023 and was completed in July 2024 and the quality assurance audited interim report was finalized in the third quarter of 2024. In the second quarter of 2025, a Phase 1 relative bioavailability study in healthy volunteers was initiated. The purpose of this study was to compare two oral formulations of GT-02287.rexaceract. This study was completed in the third quarter of 2025.

In March 2025, we enrolled the first participant with Parkinson’s disease in our two-part Phase 1b safety and tolerability study to further evaluate the safety, tolerability and biomarker evidence of activity for GT-02287.rexaceract. In Part 1 of this study, participants dose daily with GT-02287rexaceract for 90 days. In August 2025, we amended the Phase 1b clinical study to include an additional nine (9) months of daily oral administration of GT-02287rexaceract in the optional Part 2 of the Phase 1b. Participants enrolled in the Phase 1b are also followed for clinical signs of worsening or improvement. Through September 2025 a total of 21 patients were enrolled in the Phase 1b. Samples of cerebrospinal fluid were taken at the initiation of dosing and at day 90 following completion of Part 1, and blood samples were taken at multiple timepoints. In November 2025 a total of 19 patients had completed Part 1 of the Phase 1b and we will be presenting the full analysis of Part 1 throughout 2026.1b. Of the 19 patients who completed Part 1 of the Phase 1b, a total of 16 patients elected to continue on daily oral administration of GT-02287.rexaceract. We expect to complete Part 2 of the Phase 1b study in SeptemberOctober 2026.

In January 2026, we released additional biomarker and clinical data from the Phase 1b study of GT-02287rexaceract in Parkinson's disease. Participants with elevated baseline cerebrospinal fluid glucosylsphingosine demonstrated a reduction in levels following three months of treatment, and in the efficacy analysis they showed an improvement in combined MDS-UPDRS Part II and Part III scores compared to the rest of the participants. We hosted a virtual KOL event the same day featuring key opinion leaders to contextualisecontextualize the results.

In March 2026, we presented new data on our lead candidate GT-02287rexaceract at the AD/PD 2026 Conference in Copenhagen. In addition to the the elevated baseline cerebrospinal fluid glucosylsphingosine that was associated with an improvement in combined MDS-UPDRS Part II and Part III scores following administration of GT-02287rexaceract reported earlier, the new data showed those same participants also had a decrease in cerebrospinal fluid levels of DOPA decarboxylase (DDC), an enzyme responsible for synthesizing dopamine from its precusorprecursor L-DOPA, following GT-02287rexaceract treatment. DDC is elevated in people with Parkinson’s disease, so a reduction could suggest a slowing of neurodegeneration. In the ongoing Phase 1b Parkinson's disease study, 16 of 19 participants elected to enter the nine-month extension, and an independent Data Monitoring Committee endorsed continuation without modification. We also unveiled preclinical data on a structurally distinct series of allosteric GCase modulators, led by GT-04686, now ready to advance into IND-enabling studies.

In July 2025, we completed the public offering of 4,501,640 shares of our common stock and warrants to purchase 2,250,820 shares of our common stock. The warrants were offered and sold at a rate of one warrant for every two shares of common stock purchased. The public offering price for each set of two shares of common stock and accompanying warrant to purchase one share of common stock was $3.11, yielding an effective price of $1.55 per share and $0.01 per warrant. Each warrant has an exercise price of $1.65 per share of common stock and was immediately exercisable on the date of issuance. The public offering resulted in gross proceeds of $7.0 million, which included $1.0 million in offering expenses, such as underwriter fees and legal, audit, and advisory costs, for net proceeds of $6.0 million. As of December 31, 2025, 1,146,821 public warrants were exercised resulting in the issuance of 1,146,821 shares of common stock and net proceeds to us of $1.9 million. InDuring the firstsix quartermonths ended MarchJune 31,30, 2026, 1,250 public warrants were exercised resulting in the issuance of 1,250 shares of common stock and additional net proceeds to us of $2 thousand.

In September 2024, we entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Oppenheimer & Co. Inc., serving as agent (“Oppenheimer”) with respect to an at-the-market (“ATM”) offering program (the “2024 ATM Program”). Under the 2024 ATM Program we may offer and sell, from time to time at our sole discretion, shares of common stock having an aggregate offering price of up to $50.0 million. We pay Oppenheimer a commission equal to 3.0% of the gross sales proceeds of any shares sold through Oppenheimer under the Distribution Agreement. For the three months ended MarchJune 31,30, 2026, we sold an aggregate of 184,662779,040 shares of common stock at an average selling price of $2.39$1.97 per share under the 2024 ATM Program, for total gross proceeds of $0.4$1.5 million, which included $13$46 thousand of sales commissions and $94 thousand of other offering expenses for net proceeds of $0.4$1.4 million. AsFor ofthe Marchsix 31,months ended June 30, 2026, we sold an aggregate of 8,632,469963,702 shares of common stock at an average selling price of $2.59$2.05 per share under the 2024 ATM Program, for total gross proceeds of $22.4$2 million, which included $59 thousand of sales commissions and $94 thousand of other offering expenses for net proceeds of $1.8 million. As of June 30, 2026, we sold an aggregate of 9,411,509 shares of common stock at an average selling price of $2.54 per share under the 2024 ATM Program, for total gross proceeds of $23.9 million, which included $0.7 million of sales commissions and $0.3$0.4 million in other offering expenses for net proceeds of $21.4$22.8 million. From AprilJuly 1, 2026 through MayAugust 8,7, 2026, we sold an aggregate of 296,697300,229 shares of common stock through the 2024 ATM Program at an average selling price of $2.04$1.85 for total gross proceeds of $0.60$0.56 million, which included $18$17 thousand inof sales commissions and other offering expenses for net proceeds of $0.59$0.54 million.

From inception through MarchJune 31,30, 2026, we have raised an aggregate of $120$122 million of gross proceeds through equity financing, including the issuance of convertible preferred stock, our initial public offering, secondary offerings and previous sales under our ATM programs. We have outstanding warrants exercisable for an aggregate of 5.3 million shares of our common stock at a weighted-average exercise price per share of $2.37 through MarchJune 31,30, 2026 related to public and private offerings.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $16.5$13.1 million. We have incurred recurring losses and negative cash flows from operations since inception and as of MarchJune 31,30, 2026 and December 31, 2025, had an accumulated deficit of $107.0$111.6 million and $101.4 million, respectively. We anticipate incurring additional losses until such time, if ever, that we can generate sales of our product candidates currently in development. We have not generated any product revenues and have not achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and, if achieved, could be sustained on a continuing basis. In addition, we will need significant additional financing to fund our operations and to develop our product candidates. Our ability to continue operations after our current cash resources are exhausted depends on our ability to obtain additional financing or to achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in direction of our research and development programs, competitive and technical advances, patent developments, regulatory changes or other developments. If adequate additional funds are not available when required, or if we are unsuccessful in entering into partnership agreements for further development of our pipeline, management may need to curtail our development efforts and planned operations to conserve cash.

As of MarchJune 31,30, 2026 and December 31, 2025, we had an accumulated deficit of $107.0$111.6 million and $101.4 million, respectively, and as of MarchJune 31,30, 2026, we had cash and cash equivalents of $16.5$13.1 million. During the three and six months ended MarchJune 31,30, 2026, we incurred net losses of $5.6$4.7 million and $10.3 million, respectively. During the six months ended June 30, 2026, we incurred negative cash flows from operations of $4.7$9.4 million. Our current operating plan indicates that we will continue to incur losses from operations and negative cash flows from operating activities. Our projected cash outflows for the upcoming periods raise substantial doubt about our ability to continue as a going concern for at least 12 months from the issuance of the financial statements included elsewhere in this Quarterly Report. We will need to raise additional capital to fund continued operations beyond the firstsecond quarter of 2027. We plan to address our liquidity needs by taking steps to improve our operations and cash position, including identifying access to future capital and potential cost-reduction measures.

We routinely evaluate business development opportunities for the advancement of our lead program, GT-02287,rexaceract, our earlier stage pipeline, and our MagellanTM computational platform technology, including potential licensing, co-development, commercialization, and other strategic alternatives. These discussions may involve pharmaceutical companies, biotechnology companies, or other strategic partners.

Our primary research and development focus since inception has been the application of our Magellan™ platform to various indications and targets, and more recently the development of our clinical stage lead product candidate GT-02287rexaceract for the treatment of Parkinson’s disease and other neurodegenerative diseases. As of DecemberJune 31,30, 20252026 our efforts have led to the advancement of GT-02287rexaceract through Phase 1 testing and preparing to initiate Phase 2 clinical testing during third quarter of 2026.

The following table summarizes our results of operations for the three and six months ended MarchJune 31,30, 2026 and 2025.

Comparison of the Three Months and Six Months Ended MarchJune 31,30, 2026 and 2025

Research and development expenses increaseddecreased by $0.5$0.6 million to $2.1 million for the three months ended June 30, 2026, as compared to $2.8 million for the three months ended MarchJune 31,30, 2025. Research and development expenses decreased by $0.1 million to $4.9 million for the six months ended June 30, 2026, as compared to $2.3$5.0 million for the threesix months ended MarchJune 31,30, 2025. The increasesdecrease in research and development expenses were primarily related to lower costs associated with our lead program compound GT-02287rexaceract for the treatment of Parkinson’s Disease,Disease and optimization of the pipeline together with lower research and development personnel expenses, partially offset by the expiration of the grant awarded by Innosuisse under the Swiss Accelerator program in April 2026 and unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar and higher research and development personnel costs.dollar.

General and administrative expenses increased by $0.5$0.2 million to $2.6$2.5 million for the three months ended MarchJune 31,30, 2026, as compared to $2.1$2.3 million for the three months ended MarchJune 31,30, 2025. General and administrative expenses increased by $0.7 million to $5.1 million for the six months ended June 30, 2026, as compared to $4.4 million for the six months ended June 30, 2025. The increasesincrease in general and administrative expenses for the period were primarily attributable to higher professional fees, higher personnel costs, and unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar.

Interest income, net increased by $53$18 thousand to $93$61 thousand for the three months ended MarchJune 31,30, 2026, as compared to $40$43 thousand for the three months ended MarchJune 31,30, 2025. Interest income, net increased by $71 thousand to $154 thousand for the six months ended June 30, 2026, as compared to $83 thousand for the six months ended June 30, 2025. The increase was mainly attributable to higher interest income from a higher balance in our money market fund over the comparative periods.

Foreign exchange loss, net increaseddecreased by $65$670 thousandthousand, toresulting $165in a gain of $49 thousand for the three months ended MarchJune 31,30, 2026, as compared to $101a loss of $621 thousand for the three months ended MarchJune 31,30, 2025. Foreign exchange loss, net decreased by $605 thousand to $116 thousand for the six months ended June 30, 2026, as compared to $722 thousand for the six months ended June 30, 2025. The increasedecrease was due to the unfavorable foreign currency exchange as the Swiss franc and Australian dollar strengthened against the U.S. dollar.

Income taxes were $183$104 thousand and $101$141 thousand for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The decrease was mainly attributable to lower corporate taxes in Australia. Income taxes were $287 thousand and $242 thousand for the six months ended June 30, 2026 and 2025, respectively. The increase was mainly attributable to higher corporate taxes in Australia.

As of MarchJune 31,30, 2026 and December 31, 2025, we had $16.5$13.1 million and $20.8 million in cash and cash equivalents, respectively, and an accumulated deficit of $107.0$111.6 million and $101.4 million, respectively. We had indebtedness of $0.37$0.34 million and $0.40 million as of MarchJune 31,30, 2026 and December 31, 2025, respectively. Our cash and cash equivalents available as of MarchJune 31,30, 2026 are expected to be sufficient to fund our anticipated operating and capital requirements into the firstsecond quarter of 2027 but will not be sufficient to finance our operations for one year from the issuance of the financial statements included in this Quarterly Report. Therefore, we have reported that there is substantial doubt about our ability to continue as a going concern. Please refer to the discussion above titled “Going Concern”.

Until such time, if ever, as we can generate substantial product revenues to support our business and corporate strategy, we expect to finance our cash needs through a combination of public and private equity offerings, debt financings, government or private party grants, collaborations, strategic alliances, and licensing arrangements. As of MarchJune 31,30, 2026, we did not maintain any lines of credit or equity capital committed for funding with the exception of the 2024 ATM Program.

Operating cash flow used during the threesix months ended MarchJune 31,30, 2026 increased compared to the prior-year period primarily due to a higher net loss (excluding non-cash items such as stock-based compensation and foreign currency transaction gains or losses) and changes in working capital. During the threesix months ended MarchJune 31,30, 2026 and 2025, we used $4.7$9.4 million and $3.8$8.9 million of cash, respectively, in operating activities primarily to fund our operations related to the development of our pipeline and product candidates as well as related general and administrative support activities.

During the threesix months ended MarchJune 31,30, 2026 and 2025, cash provided by financing activities was $0.4$1.8 million and $2.4$4.9 million, respectively, primarily due primarily to net proceeds from the issuance of shares pursuant to the 2024 ATM Program.

Our management’s discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, defined benefit pension liability, stock-based compensation and recognition of research grants. Our actual results may differ from these estimates under different assumptions or conditions. During the threesix months ended MarchJune 31,30, 2026, there were no material changes to our critical accounting policies. For additional information, see Item 8 of Part II, “Financial Statements and Supplementary Data — Note 2 — Summary of Significant Accounting Policies” of our Annual Report and Item 1 of Part I, “Financial Statements — Note 2 — Summary of Significant Accounting Policies” of this Quarterly Report. Although we believe that our estimates, assumptions, and judgments are reasonable, they are based upon information presently available. Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions.