Gain Therapeutics, Inc.

Previous wording

We are a biotechnology company developing novel small molecule therapeutics to treat diseases across several therapeutic areas, including, central nervous system (“CNS”) disorders, lysosomal storage disorders (“LSDs”) and metabolic disorders through molecular chaperoning to stabilize misfolded proteins and increase their activity, as well as other diseases that can be targeted through protein inactivation or modulation, such as oncology. We use our computational target and drug discovery platform, Magellan™, to discover novel allosteric binding sites on proteins implicated in a disease and to identify proprietary small molecules that bind these sites to modulate protein function and treat the underlying cause of the disease. We believe that Magellan™ is uniquely suited to identify allosteric binding sites on the protein surface, which are different from the active (or orthosteric) binding site where the natural ligand of the protein binds. Targeting an allosteric binding site instead of the active binding site of a protein provides numerous advantages, including: the ability to regulate proteins implicated in disease through several different mechanisms of action covering both functional and conformational effects, including stabilization, destabilization, targeted degradation, allosteric

Current wording

We are a biotechnology company developing novel small molecule therapeutics to treat diseases across several therapeutic areas, including central nervous system (“CNS”) disorders, lysosomal storage disorders (“LSDs”) and metabolic disorders through molecular chaperoning to stabilize misfolded proteins and increase their activity, as well as other diseases that can be targeted through protein inactivation or modulation, such as oncology. We use our computational target and drug discovery platform, Magellan™, to discover novel allosteric binding sites on proteins implicated in a disease and to identify proprietary small molecules that bind these sites to modulate protein function and treat the underlying cause of the disease. We believe that Magellan™ is uniquely suited to identify allosteric binding sites on the

Previous wording

inhibition, and allosteric activation of the targeted protein; improved specificity of small molecules because binding to an allosteric binding site is non-competitive with the natural substrate that binds to the active binding site; and the ability to identify small molecules with more favorable drug-like properties. We have used our drug discovery platform to identify novel allosteric sites and small molecules for all of our pipeline programs. We plan to continue to advance our existing research programs and initiate additional programs targeting allosteric binding sites identified with the Magellan™ platform in various therapeutic areas through academic partnerships, co-development and licensing arrangements.

Current wording

protein surface, which are different from the active (or orthosteric) binding site where the natural ligand of the protein binds. Targeting an allosteric binding site instead of the active binding site of a protein provides numerous advantages, including: the ability to regulate proteins implicated in disease through several different mechanisms of action covering both functional and conformational effects, including stabilization, destabilization, targeted degradation, allosteric inhibition, and allosteric activation of the targeted protein; improved specificity of small molecules because binding to an allosteric binding site is non-competitive with the natural substrate that binds to the active binding site; and the ability to identify small molecules with more favorable drug-like properties. We have used our drug discovery platform to identify novel allosteric sites and small molecules for all of our pipeline programs. We plan to continue to advance our existing research programs and initiate additional programs targeting allosteric binding sites identified with the Magellan™ platform in various therapeutic areas through academic partnerships, co-development and licensing arrangements.

Previous wording

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 rexaceract. In preclinical models of GBA1 Parkinson’s disease, rexaceract 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.

Current wording

Our clinical stage product candidate, rexaceract, 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 rexaceract. In preclinical models of GBA1 Parkinson’s disease, rexaceract 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, increase dopamine levels, restore locomotor and cognitive function, and reduce the levels of plasma-based neurodegeneration marker neurofilament light chain (NfL) to those of the control animals.

Previous wording

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 rexaceract. In Part 1 of this study, participants dose daily with rexaceract 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 rexaceract 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. 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 rexaceract. We expect to complete Part 2 of the Phase 1b study in October 2026.

Current wording

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 rexaceract. In Part 1 of this study, participants dose daily with rexaceract 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 rexaceract 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. 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 rexaceract. We expect to complete Part 2 of the Phase 1b study in the fourth quarter of 2026.

Previous 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.

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 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

In June 2026, the U.S. Food and Drug Administration (“FDA”) authorized our Investigational New Drug (“IND”) application for rexaceract, allowing initiation of Phase 2 clinical development of rexaceract in Parkinson’s disease with or without a GBA1 mutation in the United States. Both the Phase 1a and Phase 1b studies of rexaceract were conducted in Australia. The planned Phase 2a study of oral rexaceract in treated and untreated participants with early Parkinson’s disease is expected to enroll participants across sites in the United States, Australia, and Europe. The initiation of the Phase 2a study is anticipated to occur during the third quarter of 2026.

Current wording

In June 2026, the U.S. Food and Drug Administration (“FDA”) authorized our Investigational New Drug (“IND”) application for rexaceract, allowing initiation of Phase 2 clinical development of rexaceract in Parkinson’s disease with or without a GBA1 mutation in the United States. Both the Phase 1a and Phase 1b studies of rexaceract were conducted in Australia. The planned Phase 2a study of oral rexaceract in treated and untreated participants with early Parkinson’s disease is expected to enroll participants across sites in the United States, Australia, and Europe. The initiation of the Phase 2a study is anticipated to occur during the first quarter of 2027.

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 identifying and developing 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.

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. 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. During the six months ended June 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.

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

Previous wording

Following completion of the July 2025 public offering, the underwriter exercised the over-allotment option that was granted in connection with the public offering to purchase an additional 675,246 shares of common stock, and warrants to purchase 337,623 shares of common stock, which resulted in additional gross proceeds of $1.1 million, which included $0.1 million in offering expenses, such as underwriter fees, for net proceeds of $1.0 million. In connection with the public

Current wording

Following completion of the July 2025 public offering, the underwriter exercised the over-allotment option that was granted in connection with the public offering to purchase an additional 675,246 shares of common stock, and warrants to purchase 337,623 shares of common stock, which resulted in additional gross proceeds of $1.1 million, which included $0.1 million in offering expenses, such as underwriter fees, for net proceeds of $1.0 million. In connection with the public offering, we issued the underwriter warrants to purchase 362,382 shares of common stock at an exercise price of $1.94 per share as consideration for the services provided. The underwriter warrants provide for cashless exercise.

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 three months ended June 30, 2026, we sold an aggregate of 779,040 shares of common stock at an average selling price of $1.97 per share under the 2024 ATM Program, for total gross proceeds of $1.5 million, which included $46 thousand of sales commissions and $94 thousand of other offering expenses for net proceeds of $1.4 million. For the six months ended June 30, 2026, we sold an aggregate of 963,702 shares of common stock at an average selling price of $2.05 per share under the 2024 ATM Program, for total gross proceeds of $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 $0.4 million in other offering expenses for net proceeds of $22.8 million. From July 1, 2026 through August 7, 2026, we sold an aggregate of 300,229 shares of common stock through the 2024 ATM Program at an average selling price of $1.85 for total gross proceeds of $0.56 million, which included $17 thousand of sales commissions for net proceeds of $0.54 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 September 30, 2026, we sold an aggregate of 978,260 shares of common stock at an average selling price of $1.88 per share under the 2024 ATM Program, for total gross proceeds of $1.8 million, which included $55 thousand of sales commissions and $9 thousand of other offering expenses for net proceeds of $1.8 million. For the nine months ended September 30, 2026, we sold an aggregate of 1,941,962 shares of common stock at an average selling price of $1.96 per share under the 2024 ATM Program, for total gross proceeds of $3.8 million, which included $114 thousand of sales commissions and $103 thousand of other offering expenses for net proceeds of $3.6 million. As of September 30, 2026, we sold an aggregate of 10,389,769 shares of common stock at an average selling price of $2.48 per share under the 2024 ATM Program, for total gross proceeds of $25.7 million, which included $0.7 million of sales commissions and $0.4 million in other offering expenses for net proceeds of $24.6 million. From October 1, 2026 through November 6, 2026, we sold an aggregate of 205,579 shares of common stock through the 2024 ATM Program at an average selling price of $1.58 for total gross proceeds of $0.33 million, which includes $10 thousand of sales commissions for net proceeds of $0.32 million.

Previous wording

From inception through June 30, 2026, we have raised an aggregate of $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 June 30, 2026 related to public and private offerings.

Current wording

From inception through September 30, 2026, we have raised an aggregate of $123 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 September 30, 2026 related to public and private offerings.

Previous wording

As of June 30, 2026, we had cash and cash equivalents of $13.1 million. We have incurred recurring losses and negative cash flows from operations since inception and as of June 30, 2026 and December 31, 2025, had an accumulated deficit of $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.

Current wording

As of September 30, 2026, we had cash and cash equivalents of $11.7 million. We have incurred recurring losses and negative cash flows from operations since inception and as of September 30, 2026 and December 31, 2025, had an accumulated deficit of $114.8 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.

Previous wording

As of June 30, 2026 and December 31, 2025, we had an accumulated deficit of $111.6 million and $101.4 million, respectively, and as of June 30, 2026, we had cash and cash equivalents of $13.1 million. During the three and six months ended June 30, 2026, we incurred net losses of $4.7 million and $10.3 million, respectively. During the six months ended June 30, 2026, we incurred negative cash flows from operations of $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 second quarter of 2027. We plan to address our liquidity needs

Current wording

As of September 30, 2026 and December 31, 2025, we had an accumulated deficit of $114.8 million and $101.4 million, respectively, and as of September 30, 2026, we had cash and cash equivalents of $11.7 million. During the three and nine months ended September 30, 2026, we incurred net losses of $3.2 million and $13.4 million, respectively. During the nine months ended September 30, 2026, we incurred negative cash flows from operations of $12.5 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 second 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, 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.

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. 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

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 rexaceract for the treatment of Parkinson’s disease and other neurodegenerative diseases. As of June 30, 2026 our efforts have led to the advancement of rexaceract through Phase 1 testing and preparing to initiate Phase 2 clinical testing during third quarter of 2026.

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 rexaceract for the treatment of Parkinson’s disease and other neurodegenerative diseases. As of September 30, 2026 our

Previous wording

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.

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

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

Current wording

The following table summarizes our results of operations for the three and nine months ended September 30, 2026 and 2025.

Previous wording

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

Current wording

Comparison of the Three Months and Nine Months Ended September 30, 2026 and 2025

Previous wording

Research and development expenses decreased by $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 June 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 $5.0 million for the six months ended June 30, 2025. The decrease in research and development expenses were primarily related to lower costs associated with our lead program compound rexaceract for the treatment of Parkinson’s 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.

Current wording

Research and development expenses decreased by $1.4 million to $1.4 million for the three months ended September 30, 2026, as compared to $2.8 million for the three months ended September 30, 2025. The decrease in research and development expenses was primarily related to lower costs associated with our lead program compound rexaceract for the treatment of Parkinson’s 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. Research and development expenses decreased by $1.5 million to $6.3 million for the nine months ended September 30, 2026, as compared to $7.9 million for the nine months ended September 30, 2025. The decrease in research and development expenses was primarily related to lower costs associated with our lead program compound rexaceract for the treatment of Parkinson’s 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 compared to the prior period.

Previous wording

General and administrative expenses increased by $0.2 million to $2.5 million for the three months ended June 30, 2026, as compared to $2.3 million for the three months ended June 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 increase 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 strengthened against the U.S. dollar.

Current wording

General and administrative expenses decreased by $0.1 million to $1.8 million for the three months ended September 30, 2026, as compared to $1.9 million for the three months ended September 30, 2025. The decrease in general and administrative expenses for the period was primarily attributable to lower professional fees and personnel costs. General and administrative expenses increased by $0.5 million to $6.9 million for the nine months ended September 30, 2026, as compared to $6.4 million for the nine months ended September 30, 2025. The increase in general and

Previous wording

Interest income, net increased by $18 thousand to $61 thousand for the three months ended June 30, 2026, as compared to $43 thousand for the three months ended June 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 interest income from a higher balance in our money market fund over the comparative periods.

Current wording

Interest income, net decreased by $36 thousand to $42 thousand for the three months ended September 30, 2026, as compared to $78 thousand for the three months ended September 30, 2025. The decrease was mainly attributable to lower interest income resulting from a lower balance in our money market fund over the comparative periods. Interest income, net increased by $35 thousand to $196 thousand for the nine months ended September 30, 2026, as compared to $161 thousand for the nine months ended September 30, 2025. The increase was mainly attributable to interest income from a higher average balance in our money market fund over the comparative periods.

Previous wording

Foreign exchange loss, net decreased by $670 thousand, resulting in a gain of $49 thousand for the three months ended June 30, 2026, as compared to a loss of $621 thousand for the three months ended June 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 decrease was due to the unfavorable foreign currency exchange as the Swiss franc and Australian dollar strengthened against the U.S. dollar.

Current wording

Foreign exchange loss, net decreased by $101 thousand, resulting in a gain of $73 thousand for the three months ended September 30, 2026, as compared to a loss of $27 thousand for the three months ended September 30, 2025. Foreign exchange loss, net decreased by $706 thousand to $43 thousand for the nine months ended September 30, 2026, as compared to $749 thousand for the nine months ended September 30, 2025. The decrease was primarily due to the weakening of the Swiss franc against the U.S. dollar in 2026, compared to its strengthening in 2025.

Previous wording

Income taxes were $104 thousand and $141 thousand for the three months ended June 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.

Current wording

Income taxes were $72 thousand and $549 thousand for the three months ended September 30, 2026 and 2025, respectively. Income taxes were $360 thousand and $791 thousand for the nine months ended September 30, 2026 and 2025, respectively. The decrease was mainly attributable to lower corporate taxes in Australia.

Previous wording

As of June 30, 2026 and December 31, 2025, we had $13.1 million and $20.8 million in cash and cash equivalents, respectively, and an accumulated deficit of $111.6 million and $101.4 million, respectively. We had indebtedness of $0.34 million and $0.40 million as of June 30, 2026 and December 31, 2025, respectively. Our cash and cash equivalents available as of June 30, 2026 are expected to be sufficient to fund our anticipated operating and capital requirements into the second 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”.

Current wording

As of September 30, 2026 and December 31, 2025, we had $11.7 million and $20.8 million in cash and cash equivalents, respectively, and an accumulated deficit of $114.8 million and $101.4 million, respectively. We had indebtedness of $0.3 million and $0.4 million as of September 30, 2026 and December 31, 2025, respectively. Our cash and cash equivalents available as of September 30, 2026 are expected to be sufficient to fund our anticipated operating and capital requirements into the second 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

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 June 30, 2026, we did not maintain any lines of credit or equity capital committed for funding with the exception of the 2024 ATM Program.

Current wording

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,

Previous wording

Operating cash flow used during the six months ended June 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 six months ended June 30, 2026 and 2025, we used

Current wording

Operating cash flow used during the nine months ended September 30, 2026 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, 2026 and 2025, we used $12.5 million and $13.8 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 six months ended June 30, 2026 and 2025, cash provided by financing activities was $1.8 million and $4.9 million, respectively, primarily due to net proceeds from the issuance of shares pursuant to the 2024 ATM Program.

Current wording

During the nine months ended September 30, 2026 and 2025, cash provided by financing activities was $3.5 million and $12.0 million, respectively, primarily due to lower net proceeds from the issuance of shares pursuant to the 2024 ATM Program and the absence of a public offering in 2026, as compared to a public offering completed in 2025.

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 six months ended June 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.

Current wording

Our management’s discussion and analysis of our financial condition and results of operations is 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, 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.

Previous wording

We qualify as an “emerging growth company”, as defined in the JOBS Act. For so long as we remain an emerging growth company, we are permitted and plan to rely on exemptions from certain disclosure requirements that are applicable to public companies that are not emerging growth companies. These provisions include, but are not limited to: being permitted to report only two years of audited financial statements and only two years of related selected financial data and management’s discussion and analysis of financial conditions and results of operations disclosure; an exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act; reduced disclosure obligations regarding executive compensation arrangements in our periodic reports, registration statements and proxy statements; and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. In addition, the JOBS Act permits emerging growth companies to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. As a result, the information we provide might be different from the information that is available for other public companies. We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some

Current wording

We qualify as an “emerging growth company”, as defined in the JOBS Act. For so long as we remain an emerging growth company, we are permitted and plan to rely on exemptions from certain disclosure requirements that are applicable to public companies that are not emerging growth companies. These provisions include, but are not limited to: being permitted to report only two years of audited financial statements and only two years of related selected financial data and management’s discussion and analysis of financial condition and results of operations disclosure; an exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act; reduced disclosure obligations regarding executive compensation arrangements in our periodic reports, registration statements and proxy statements; and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. In addition, the JOBS Act permits emerging growth companies to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. As a result, the information we provide might be different from the information that is available for other public companies. We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and the market price of our common stock may be more volatile.