Gain Therapeutics, Inc.

Previous wording

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 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

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 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. We have generated an extensive preclinical data package providing evidence of the mechanism of action, in vivo pharmacology, and safety of GT-02287. In preclinical models of GBA1 Parkinson’s disease, GT-02287 has been shown to restore glucocerebrosidase, or GCase, function in the lysosome, reduce toxic lipid substrates and toxic forms of alpha-synuclein, reduce endoplasmic reticulum stress, improve mitochondrial health and overall survival of dopaminergic neurons, increasing dopamine levels, restoring locomotor and cognitive function, and reducing plasma-based neurodegeneration maker, neurofilament light chain (NfL), back to the level of control animals. In a Phase 1 first-in-human study (n = 72), GT-02287 was safe and generally well tolerated up to and including the highest planned dose level, enabling further development in GBA1 Parkinson’s patients. Additionally, administration of GT-02287 was associated with a mean increase in GCase activity of 53% among healthy volunteers at doses that were predicted to be in the therapeutic range based on preclinical models and will be carried forward in later stage trials of GT-02287. The good safety and tolerability profile and the observed range of plasma exposure levels achieved after oral administration further bolster GT-02287’s best in-class potential.

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. 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.

Previous wording

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 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

On July 17, 2025, we completed an underwritten public offering of 4,501,640 shares of our common stock and warrants to purchase 2,250,820 shares of our common stock. The public offering resulted in gross proceeds of $7.0 million, which includes $0.9 million in offering expenses for net proceeds of $6.1 million. Following completion of the 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 up to 337,623 shares of common stock which resulted in additional 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 as a consideration for the services provided.

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

On May 6, 2025, 200,000 warrants issued in 2021 to an investment bank for banking services and financial advisory were not exercised within their four year exercisable period and were therefore forfeited.

Current wording

On July 20, 2025, 225,387 warrants issued in 2020 in connection with the Series B Preferred Stock to designees of the placement agent were not exercised within their five year exercisable period and were therefore forfeited. On May 6, 2025, 200,000 warrants issued in 2021 to an investment bank for banking services and financial advisory were not exercised within their four year exercisable period and were therefore forfeited.

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 will 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, 2025, we sold an aggregate of 1,417,361 shares of common stock at an average selling price of $1.88 per share under the 2024 ATM Program, for total gross proceeds of $2.67 million, which included $176 thousand of sales commissions and other offering expenses for net proceeds of $2.49 million. For the six months ended June 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 $251 thousand of sales commissions and other offering expenses for net proceeds of $4.91 million. We have 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.

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 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.

Previous wording

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 is $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 includes $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.

Current wording

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 wording

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 includes $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 a consideration for the services provided, which provide for cashless exercise.

Current wording

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 wording

From inception through June 30, 2025, we have raised an aggregate of $94 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. Outstanding and exercisable warrants were 4.9 million at a weighted-average exercise price per share of $2.73 through June 30, 2025 related to previous public and private offerings.

Current 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.

Previous wording

As of June 30, 2025, we had cash and cash equivalents of $6.7 million. In addition, in connection with our public offering in July 2025, we received $7.1 million in net proceeds. We have incurred recurring losses and negative cash flows from operations since inception and as of June 30, 2025 and December 31, 2024, had an accumulated deficit of $91.5 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

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.

Previous wording

As of June 30, 2025 and December 31, 2024 we had an accumulated deficit of $91.5 million and $81.2 million, respectively, and as of June 30, 2025, we had cash and cash equivalents of $6.7 million. During the three and six months ended June 30, 2025, we incurred net losses of $5.8 million and $10.3 million, respectively. During the six months ended June 30, 2025, we incurred negative cash flows from operations of $8.9 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 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.

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 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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

Comparison of the Three Months and Six Months Ended June 30, 2025 and 2024

Current wording

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

Previous wording

Research and development expenses decreased by $1.7 million to $2.8 million for the three months ended June 30, 2025, as compared to $4.4 million for the three months ended June 30, 2024. Research and development expenses decreased by $1.9 million to $5.0 million for the six months ended June 30, 2025, as compared to $6.9 million for the six months ended June 30, 2024. The decreases in research and development were primarily related to recognition of research grant income, the research and development tax incentive program tax credit, and optimization of our pipeline costs and research and development personnel. The decreases were partially offset by an increase in stock-based compensation.

Current wording

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 wording

General and administrative expenses decreased by $1.4 million to $2.3 million for the three months ended June 30, 2025, as compared to $3.7 million for the three months ended June 30, 2024. General and administrative expenses decreased by $1.2 million to $4.4 million for the six months ended June 30, 2025, as compared to $5.6 million for the six months ended June 30, 2024. The decreases in general and administrative expenses for the period were primarily attributable to a decrease in stock-based compensation. The decreases were partially offset by an increase in legal and professional fees relating to general corporate matters.

Current wording

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 wording

Interest income, net decreased by $42 thousand to $43 thousand for the three months ended June 30, 2025 from $85 thousand for the three months ended June 30, 2024. Interest income, net decreased by $117 thousand to $83 thousand for the six months ended June 30, 2025 from $200 thousand for the six months ended June 30, 2024. The decreases were mainly attributable to lower interest income from treasury securities that reached final maturity in April 2024.

Current 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.

Previous wording

Foreign exchange loss, net increased by $0.6 million to a loss of $0.6 million for the three months ended June 30, 2025, as compared to $44 thousand for the three months ended June 30, 2024. Foreign exchange gain, net decreased by $0.9 million to a loss of $0.7 million for the six months ended June 30, 2025, as compared to a gain of $0.2 million for the six months ended June 30, 2024. The decreases were mainly attributable 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 $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.

Previous wording

Income taxes were $141 thousand and $1 thousand for the three months ended June 30, 2025 and 2024, respectively. Income taxes were $242 thousand and $21 thousand for the six months ended June 30, 2025 and 2024, respectively. The increases were mainly attributable to higher income taxes payable in Australia.

Current 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.

Previous wording

As of June 30, 2025 and December 31, 2024, we had $6.7 million and $10.4 million in cash and cash equivalents, respectively, and an accumulated deficit of $91.5 million and $81.2 million, respectively. In addition, in connection with our public offering in July 2025, we received $7.1 million in net proceeds. We had indebtedness of $0.5 million and $0.4 million as of June 30, 2025 and December 31, 2024, respectively. Together with the cash raised during the July 2025 public offering and our cash and cash equivalents available as of June 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 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”.

Previous wording

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

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 the 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

Until such time, if ever, as we can generate substantial product revenues to support our business and corporate strategy, we expect to finance our cash needs through a combination of public and private equity offerings, including sales under our 2024 ATM Program, debt financings, government or private party grants, collaborations, strategic alliances, and licensing arrangements. As of June 30, 2025, 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, government or private party grants, collaborations, strategic alliances, and licensing arrangements. As of September 30, 2025, we did not maintain any lines of credit or equity capital committed for funding with the exception of the 2024 ATM Program.

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 rising interest rates, 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 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.

Previous wording

Operating cash flow used during the six months ended June 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 six months ended June 30, 2025 and 2024, we used $8.9 million and $9.3 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 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.

Previous wording

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

Current wording

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 wording

During the six months ended June 30, 2025, cash provided by financing activities was $4.9 million due to net proceeds from the issuance of shares pursuant to the 2024 ATM Program.

Current 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.

Previous wording

During the six months ended June 30, 2024, cash provided by $9.9 million mainly related to the following: $10.0 million provided by net proceeds from issuance of shares and warrants in public offering and $0.1 million provided by the exercise of public warrants, partially offset by $0.2 million payment of deferred offering costs.

Current wording

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.

Previous wording

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of public and private equity offerings, debt financings, at-the-market offerings, government or private party grants, collaborations, strategic alliances, and licensing arrangements. We may not be able to obtain additional funds through equity or debt financings when needed on favorable terms or at all.

Current wording

Until such time, if ever, we can generate substantial product revenue, we expect to finance our operations through a combination of public and private equity offerings, debt financings, at-the-market offerings, government or private party grants, collaborations, strategic alliances, and licensing arrangements. We may not be able to obtain additional funds through equity or debt financings when needed on favorable terms or at all.

Previous 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 six months ended June 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

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.