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Gain Therapeutics, Inc.

For the period ended Mar 31, 2026. Filed May 11, 2026.

View on SEC.gov

About this filing

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

Mar 31, 2026 · Filed May 11, 2026

GANX$1.03+7.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-12.

0001104659-25-110347

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

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-11.

0001104659-26-058649

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

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

Compared 86 previous paragraphs and 85 current paragraphs.

46 unchanged; 26 reworded; 8 added; 13 removed; 1 previous and 5 current paragraphs rearranged.

Tables are not compared: 17 previous and 21 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

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

Added paragraphs (8)

Current report

As of March 31, 2026, two clinical studies of GT-02287 have been completed, and one is ongoing. GT-02287 was initially characterized in a first-in-human Phase 1a clinical study to assess the safety, tolerability, pharmacokinetics, and food effect of GT-02287 in healthy participants. The study design included a single ascending dose part during which the study participants received one dose of GT-02287 at different dose levels, and a multiple ascending dose part during which the study participants received one daily dose of GT-02287 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

Current report

was initiated. The purpose of this study was to compare two oral formulations of GT-02287. This study was completed in the third quarter of 2025.

Current report

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. In Part 1 of this study, participants dose daily with GT-02287 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-02287 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. 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. We expect to complete Part 2 of the Phase 1b study in September 2026.

Current report

In January 2026, we released additional biomarker and clinical data from the Phase 1b study of GT-02287 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 contextualise the results.

Current report

In March 2026, we presented new data on our lead candidate GT-02287 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-02287 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 precusor L-DOPA, following GT-02287 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.

Current report

We routinely evaluate business development opportunities for the advancement of our lead program, GT-02287, our earlier stage pipeline, and our Magellan TM 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.

Current report

While we continue to assess opportunities that could enhance shareholder value and support the advancement of our development programs, there can be no assurance that any such discussions will result in the execution of a definitive agreement. We intend to pursue transactions that we believe align with our strategic objectives, strengthen our financial position, and accelerate the development and potential commercialization of our lead candidate.
Removed paragraphs (13)

Previous report

In October 2025 we presented early results from its Phase 1b clinical study in patients with Parkinson’s disease at the International Congress of Parkinson’s Disease and Movement Disorders®. GT-02287 was generally well tolerated,

Previous report

with no treatment-emergent serious adverse events observed. Additionally, participants in the open label trial appear to be benefitting from stabilization and trending improvements in their MDS-UPDRS scores after 90 days of GT-02287 administration.

Previous report

In September 2025 we elected to extend the open label study for an additional 9 months to allow participants interested in remaining on GT-02287 to continue on the study. The majority of participants have elected to remain on the open label extension.

Previous report

In June 2024, we completed the public offering of 7.1 million shares of our common stock and 1.0 million pre-funded warrants (the “Pre-Funded Warrants”) to purchase an equal amount of our common stock at the nominal exercise price of $0.0001. The public offering price was $1.35 per share while the purchase price of each pre-funded warrant was equal to the public offering price at which a share of common stock was sold to the public in this offering, minus $0.0001. The public offering resulted in gross proceeds of $11.0 million, which included $1.2 million of underwriting commissions and other expenses connected with the financing round. In the first quarter ended March 31, 2025, 454,893 Pre-Funded Warrants were exercised resulting in the issuance of 454,893 shares of common stock. In the second quarter ended June 30, 2025, 576,709 Pre-Funded Warrants were exercised resulting in the issuance of 576,709 shares of common stock.

Previous report

As part of the public offering in June 2024, we granted the underwriter an over-allotment option to purchase up to an additional 1,222,222 shares of our 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 option resulted in gross proceeds of $0.46 million, which included $42 thousand of underwriting commissions and other expenses connected with the exercise of the option. We also issued 593,965 warrants to purchase an equal amount of our common stock at an exercise price of $1.6875 per share to the underwriter as consideration for the services provided, which provide for cashless exercise.

Previous report

In connection with our business development activities, we are looking to enter into collaboration and licensing arrangements with third parties, to use our licensed Magellan™ computational platform technology to discover novel allosteric sites on proteins and identify proprietary small molecules that bind these sites and may be developed into pharmaceutical products. We expect to continue to identify and evaluate collaboration, co-development and licensing opportunities that may be similar to or different from the collaboration and licensing arrangements that we have entered into.

Previous report

Research and development expenses decreased by $1.7 million to $7.9 million for the nine months ended September 30, 2025, as compared to $9.6 million for the nine months ended September 30, 2024. The decreases in research and development expenses were primarily related to the recognition of research grant income, the research and development tax incentive program tax credit, the optimization of our pipeline costs and lower research and development personnel costs. The decreases were partially offset by unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar.

Previous report

General and administrative expenses decreased by $1.1 million to $6.4 million for the nine months ended September 30, 2025, as compared to $7.5 million for the nine months ended September 30, 2024. The decreases in general and administrative expenses for the period were primarily attributable to lower stock-based compensation. The decreases were partially offset by higher legal and professional fees related to general corporate matters and unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar.

Previous report

Foreign exchange loss, net decreased by $94 thousand to a loss of $27 thousand for the three months ended September 30, 2025, as compared to $121 thousand for the three months ended September 30, 2024. The decrease was mainly attributable to stabilization of exchange rates within the three month period.

Previous report

During the nine months ended September 30, 2024, net cash provided by investing activities was $5.0 million due to the maturity of marketable securities.

Previous report

During the nine months ended September 30, 2024, cash provided by financing activities was $10.7 million mainly related to the following: $10.2 million provided by net proceeds from issuance of shares and warrants in the June 2024 public offering, $0.6 million provided by net proceeds from the issuance of shares pursuant to the 2024 ATM Program, and $0.2 million provided by the exercise of public warrants and stock options, partially offset by $0.3 million payment of deferred offering costs.
Reworded paragraphs (26)

Previous wording

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 marker, 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.

Current wording

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 marker, neurofilament light chain (NfL), back to the level of control animals.

Previous wording

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-Israel conflict, global geopolitical tension, exchange rate fluctuations, supply chain disruptions, liquidity concerns and increases in commodity, energy and fuel prices.

Current wording

We continue to monitor the impacts on our operations and access to financing from; global and worsening macroeconomic conditions, such as the war in Ukraine, the recent 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.

Previous wording

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. Our operations have consisted primarily of expanding our operations, securing financing, performing research, conducting preclinical and clinical studies and 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 programs, 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.

Current wording

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. Our operations have consisted primarily of expanding our operations, securing financing, performing research, conducting preclinical and clinical studies and 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 programs, achieve our research and development objectives, defend our

Previous wording

At our annual meeting held on June 24, 2025, the stockholders approved an amendment to our Amended and Restated Certificate of Incorporation to increase our authorized shares of common stock from 50,000,000 to 100,000,000. The amendment did not change any of the current rights and privileges of our common stock or its par value, and did not affect the number of shares of our common stock outstanding.

Current wording

At our annual meeting held on June 24, 2025, our stockholders approved an amendment to our Amended and Restated Certificate of Incorporation to increase our authorized shares of common stock from 50,000,000 to 100,000,000. The amendment did not change any of the current rights and privileges of our common stock or its par value, and did not affect the number of shares of our common stock outstanding.

Previous wording

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. In the third quarter ended September 30, 2025, 25,300 public warrants were exercised resulting in the issuance of 25,300 shares of common stock and additional net proceeds of $42 thousand. In October 2025, 60,615 public warrants were exercised resulting in the issuance of 60,615 shares of common stock and additional net proceeds of $100 thousand.

Current wording

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. In the first quarter ended March 31, 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.

Previous wording

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 nine months ended September 30, 2025, we sold an aggregate of 2,512,062 shares of common stock at an average selling price of $2.05 per share under the 2024 ATM Program, for total gross proceeds of $5.16 million, which included $0.25 million of sales commissions and other offering expenses for net proceeds of $4.91 million. As of September 30, 2025, we sold an aggregate of 4,109,190 shares of common stock at an average selling price of $2.02 per share under the 2024 ATM Program, for total gross proceeds of $8.3 million, which included $0.44 million of sales commissions and other offering expenses for net proceeds of $7.86 million. From October 1, 2025 through November 11, 2025, we sold an aggregate of 703,987 shares of common stock through the 2024 ATM Program at an average selling price of $2.15 for total gross proceeds of $1.51 million, which included $45 thousand in sales commissions and other offering expenses for net proceeds of $1.47 million.

Current wording

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 March 31, 2026, we sold an aggregate of 184,662 shares of common stock at an average selling price of $2.39 per share under the 2024 ATM Program, for total gross proceeds of $0.4 million, which included $13 thousand of sales commissions for net proceeds of $0.4 million. As of March 31, 2026, we sold an aggregate of 8,632,469 shares of common stock at an average selling price of $2.59 per share under the 2024 ATM Program, for total gross proceeds of $22.4 million, which included $0.7 million of sales commissions and $0.3 million in other offering expenses for net proceeds of $21.4 million. From April 1, 2026 through May 8, 2026, we sold an aggregate of 296,697 shares of common stock through the 2024 ATM Program at an average selling price of $2.04 for total gross proceeds of $0.60 million, which included $18 thousand in sales commissions and other offering expenses for net proceeds of $0.59 million.

Previous wording

From inception through September 30, 2025, we have raised an aggregate of $103 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 for 7.6 million shares of our common stock at a weighted-average exercise price per share of $2.26 through September 30, 2025 related to public and private offerings. Of the 7.6 million outstanding warrants, 7.2 million warrants are exercisable at a weighted-average exercise price per share of $2.27 as of September 30, 2025.

Current wording

From inception through March 31, 2026, we have raised an aggregate of $120 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 March 31, 2026 related to public and private offerings.

Previous wording

As of September 30, 2025, we had cash and cash equivalents of $8.8 million. We have incurred recurring losses and negative cash flows from operations since inception and as of September 30, 2025 and December 31, 2024, had an accumulated deficit of $96.8 million and $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.

Current wording

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.

Previous wording

As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $96.8 million and $81.2 million, respectively, and as of September 30, 2025, we had cash and cash equivalents of $8.8 million. During the three and nine months ended September 30, 2025, we incurred net losses of $5.3 million and $15.6 million, respectively. During the nine months ended September 30, 2025, we incurred negative cash flows from operations of $13.8 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 first quarter of 2026. 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.

Current wording

As of March 31, 2026 and December 31, 2025, we had an accumulated deficit of $107.0 million and $101.4 million, respectively, and as of March 31, 2026, we had cash and cash equivalents of $16.5 million. During the three months ended March 31, 2026, we incurred net losses of $5.6 million and negative cash flows from operations of $4.7 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 first 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.

Previous wording

Uncertain 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 tension, and the post COVID-19 environment 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, volatility in the capital markets, and related market uncertainty, may impact our ability to obtain additional financing when needed on favorable terms or at all.

Current wording

Uncertain 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, global geopolitical tensions, such as the ongoing conflict between Russia and Ukraine and between the United States and Iran and elsewhere in the Middle East 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, volatility in the capital markets, and related market uncertainty, may impact our ability to obtain additional financing when needed on favorable terms or at all.

Previous wording

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 progression 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.

Current wording

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 progression 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

Previous wording

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.

Current wording

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.

Previous wording

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 may increase in the foreseeable future as we (i) increase personnel costs, including stock-based

Current wording

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 may 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.

Previous wording

Other financial income (expense) consists of interest income, interest expense, and foreign exchange gain or loss.

Current wording

Other financial income (expense) consists of interest income, interest expense, and foreign exchange gain or loss, net.

Previous wording

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

Current wording

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

Previous wording

Comparison of the Three Months and Nine Months Ended September 30, 2025 and 2024

Current wording

Comparison of the Three Months Ended March 31, 2026 and 2025

Previous wording

Research and development expenses increased by $0.2 million to $2.8 million for the three months ended September 30, 2025, as compared to $2.6 million for the three months ended September 30, 2024. The increases in research and development expenses were primarily related to costs associated with the ongoing Phase 1b clinical trial and unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar. The increases were partially offset by optimization of our pipeline costs and lower research and development personnel costs.

Current wording

Research and development expenses increased by $0.5 million to $2.8 million for the three months ended March 31, 2026, as compared to $2.3 million for the three months ended March 31, 2025. The increases in research and development expenses were primarily related to costs associated with our lead program compound GT-02287 for the treatment of Parkinson’s Disease, 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.

Previous wording

General and administrative expenses increased by $0.1 million to $1.9 million for the three months ended September 30, 2025, as compared to $1.8 million for the three months ended September 30, 2024. The increases in general and administrative expenses for the period were primarily attributable to higher stock-based compensation, higher personnel costs, and unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar. The increases were partially offset by lower legal and professional fees related to general corporate matters.

Current wording

General and administrative expenses increased by $0.5 million to $2.6 million for the three months ended March 31, 2026, as compared to $2.1 million for the three months ended March 31, 2025. The increases 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.

Previous wording

Interest income, net decreased by $27 thousand to $78 thousand for the three months ended September 30, 2025, as compared to $105 thousand for the three months ended September 30, 2024. Interest income, net decreased by $144 thousand to $161 thousand for the nine months ended September 30, 2025, as compared to $305 thousand for the nine months ended September 30, 2024. The decreases were mainly attributable to lower interest income from treasury securities that reached final maturity in April 2024 and a lower balance in our money market fund over the comparative periods.

Current wording

Interest income, net increased by $53 thousand to $93 thousand for the three months ended March 31, 2026, as compared to $40 thousand for the three months ended March 31, 2025. The increase was mainly attributable to higher interest income from a higher balance in our money market fund over the comparative periods.

Previous wording

Foreign exchange loss, net increased by $0.9 million to a loss of $0.7 million for the nine months ended September 30, 2025, as compared to a gain of $0.1 million for the nine months ended September 30, 2024 due to the unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar.

Current wording

Foreign exchange loss, net increased by $65 thousand to $165 thousand for the three months ended March 31, 2026, as compared to $101 thousand for the three months ended March 31, 2025. The increase was due to the unfavorable foreign currency exchange as the Swiss franc and Australian dollar strengthened against the U.S. dollar.

Previous wording

Income taxes were $549 thousand and $11 thousand for the three months ended September 30, 2025 and 2024, respectively. Income taxes were $791 thousand and $32 thousand for the nine months ended September 30, 2025 and 2024, respectively. The increases were mainly attributable to higher corporate taxes in Australia.

Current wording

Income taxes were $183 thousand and $101 thousand for the three months ended March 31, 2026 and 2025, respectively. The increase was mainly attributable to higher corporate taxes in Australia.

Previous wording

As of September 30, 2025 and December 31, 2024, we had $8.8 million and $10.4 million in cash and cash equivalents, respectively, and an accumulated deficit of $96.8 million and $81.2 million, respectively. We had indebtedness of $0.4 million as of September 30, 2025 and December 31, 2024. For the nine months ended September 30, 2025, we raised $7.1 million in net proceeds from our July 2025 public offering and $4.9 million in net proceeds under the 2024 ATM Program. Our cash and cash equivalents available as of September 30, 2025 are expected to be sufficient to fund our anticipated operating and capital requirements into the first quarter of 2026 and 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”.

Current wording

As of March 31, 2026 and December 31, 2025, we had $16.5 million and $20.8 million in cash and cash equivalents, respectively, and an accumulated deficit of $107.0 million and $101.4 million, respectively. We had indebtedness of $0.37 million and $0.40 million as of March 31, 2026 and December 31, 2025, respectively. Our cash and cash equivalents available as of March 31, 2026 are expected to be sufficient to fund our anticipated operating and capital requirements into the first 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”.

Previous wording

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. We may not be able to obtain additional funds through equity or debt financings when needed on favorable terms or at all, including as a result of interest rate uncertainty, liquidity concerns at, and failures of, banks and other financial institutions, volatility in the capital markets and related market uncertainty. Further, if we are unable to obtain additional funding to support our current or proposed activities and operations, we may not be able to continue our operations as currently anticipated, which may require us to suspend or terminate any ongoing development activities, modify our business plan, curtail various aspects of our operations, cease operations, or seek relief under applicable bankruptcy laws.

Current wording

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may

Previous wording

Operating cash flow used during the nine months ended September 30, 2025 decreased compared to the prior-year period primarily due to a lower 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 nine months ended September 30, 2025 and 2024, we used $13.8 million and $15.4 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.

Current wording

Operating cash flow used during the three months ended March 31, 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 three months ended March 31, 2026 and 2025, we used $4.7 million and $3.8 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.

Previous wording

During the nine months ended September 30, 2025, cash provided by financing activities was $12.0 million due to net proceeds from the issuance of shares pursuant to the 2024 ATM Program and net proceeds from the issuance of shares and warrants exercised in connection with our July 2025 public offering, partially offset by a repayment of $0.1 million of our long-term debt.

Current wording

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

Previous wording

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 nine months ended September 30, 2025, 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.

Current wording

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 three months ended March 31, 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.
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Current report — wording carried from elsewhere

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.

Current report — wording carried from elsewhere

As of March 31, 2026, we had cash and cash equivalents of $16.5 million. We have incurred recurring losses and negative cash flows from operations since inception and as of March 31, 2026 and December 31, 2025, had an accumulated deficit of $107.0 million and $101.4 million, respectively. We anticipate incurring additional losses until such time, if ever,

Current report — wording carried from elsewhere

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.

Current report — wording carried from elsewhere

reduce the value of our common stock. We may not be able to obtain additional funds through equity or debt financings when needed on favorable terms or at all, including as a result of interest rate uncertainty, liquidity concerns at, and failures of, banks and other financial institutions, volatility in the capital markets and related market uncertainty. Further, if we are unable to obtain additional funding to support our current or proposed activities and operations, we may not be able to continue our operations as currently anticipated, which may require us to suspend or terminate any ongoing development activities, modify our business plan, curtail various aspects of our operations, cease operations, or seek relief under applicable bankruptcy laws.

Current report — wording carried from elsewhere

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
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

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.