What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-26 compared with 2025-03-27 · 115 added, 80 removed, 181 unchanged (52% of the section changed)

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In preclinical models of GBA1 Parkinson’s disease, GT-02287 has been shown to restore glucocerebrosidase, or GCase, function in the lysosome, reduce toxic lipid substrates and toxic forms of alpha-synuclein, reduce endoplasmic reticulum stress, improve mitochondrial health and overall survival of dopaminergic neurons, increasing dopamine levels, restoring locomotor and cognitive function, and reducing plasma-based neurodegeneration maker, neurofilament light chain (NfL), back to the level of control animals.

In a Phase 1 first-in-human study (n = 72), GT-02287 was safe and generally well tolerated up to and including

the highest planned dose level, enabling further development in GBA1 Parkinson’s patients.

Additionally, administration of GT-02287 was associated with a mean increase in GCase activity of 53% among healthy volunteers at doses that were predicted to be in the therapeutic range based on preclinical models and will be carried forward in later stage trials of GT-02287.

The good safety and tolerability profile and the observed range of plasma exposure levels achieved after oral administration further bolster GT-02287’s best in-class potential.

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

As of December 31, 2025, two clinical studies of GT-02287 have been completed, and one is ongoing.

GT-02287 was initially characterized in a first-in-human Phase 1a clinical study to assess the safety, tolerability, pharmacokinetics, and food effect of GT-02287 in healthy participants.

The study design included a single ascending dose part during which the study participants received one dose of GT-02287 at different dose levels, and a multiple ascending dose part during which the study participants received one daily dose of GT-02287 for 14 days at different dose levels.

The Phase 1a study started in September 2023 and was completed in July 2024 and the quality assurance audited interim report was finalized in the third quarter of 2024.

In the second quarter of 2025, a Phase 1 relative

bioavailability study in healthy volunteers was initiated.

The purpose of this study was to compare two oral formulations of GT-02287.

This study was completed in the third quarter of 2025.

In March 2025, we enrolled the first participant with Parkinson’s disease in our two-part Phase 1b safety and tolerability study to further evaluate the safety, tolerability and biomarker evidence of activity for GT-02287.

In Part 1 of this study, participants dose daily with GT-02287 for 90 days.

In August 2025, we amended the Phase 1b clinical study to include an additional nine (9) months of daily oral administration of GT-02287 in the optional Part 2 of the Phase 1b.

Participants enrolled in the Phase 1b are also followed for clinical signs of worsening or improvement.

Through September 2025 a total of 21 patients were enrolled in the Phase 1b.

Samples of cerebrospinal fluid were taken at the initiation of dosing and at day 90 following completion of Part 1, and blood samples were taken at multiple timepoints.

In November 2025 a total of 19 patients had completed Part 1 of the Phase 1b and we will be presenting the full analysis of Part 1 throughout 2026.

Of the 19 patients who completed Part 1 of the Phase 1b, a total of 16 patients elected to continue on daily oral administration of GT-02287.

We expect to complete Part 2 of the Phase 1b study in September 2026.

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

Financial Condition

Since our inception in 2017, we have devoted substantially all of our resources to identify and develop next-generation brain-penetrant allosteric small molecules for the treatment of devastating diseases with high-unmet medical needs using our Magellan™ platform.

As of December 31, 2025 our efforts have led to the advancement of our lead clinical candidate, GT-02287 for the treatment of Parkinson’s disease through Phase 1 testing and preparing to initiate Phase 2 clinical testing during the third quarter of 2026.

Our operations have consisted primarily of organizing and staffing the Company, expanding its operations, securing financing, performing research, conducting preclinical studies and acquiring, developing and securing our in-licensed technology.

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Even if our product development efforts are successful, it is uncertain when, if ever, we will realize significant revenue from product sales.

In May 2022, we filed a shelf registration statement on Form S-3, which covers the offering, issuance and sale of up to a maximum aggregate offering price of $100.0 million of any combination of our common stock, preferred stock, debt securities and/or warrants from time to time in one or more offerings.

In the second quarter of fiscal year 2022, we entered into a Controlled Equity Offering Sales Agreement (the “Cantor Sales Agreement”), with Cantor Fitzgerald & Co.

(“Cantor”), pursuant to which we were able to offer and sell shares of our common stock having an aggregate offering price of up to $16.0 million from time to time through or to Cantor, acting as our agent or principal, in a series of one or more at-the-market equity offerings.

During the year ended December 31, 2023, we sold an aggregate of 862,535 shares of common stock at an average price of $4.60 per share, raising gross proceeds of $3.9 million, which included $0.4 million in sales and commissions and other offering expenses.

The Cantor Sales Agreement was terminated in conjunction with the public offering and concurrent private placement of shares of our common stock in November 2023, as described below.

In November 2023, we completed the public offering of 2.5 million shares of our common stock and warrants to purchase 1.3 million shares of our common stock.

The warrants have an exercise price of $2.75 per share and were sold at the rate of one warrant for every two shares of common stock purchased in the public offering.

The public offering price for each set of two shares of common stock and accompanying warrant to purchase one share of common stock was $4.01 (with an effective price of $2.00 per share and $0.01 per warrant).

In a private placement that was completed concurrently with the public offering we also issued to accredited investors 2.5 million of shares of our common stock (or pre-funded warrants in lieu thereof) and private warrants to purchase 2.5 million shares of our common stock with an exercise price of $2.75 per share.

The private offering price per share and accompanying warrant in the private placement was $2.00 per set of securities sold privately.

The public offering and the concurrent private placement resulted in combined gross proceeds of $10.1 million, which included $1.2 million of underwriting commissions, placement agent’s fees and other expenses connected with the financing round.

Additionally, a total of 353,156 warrants to purchase an equal amount of our common stock at an exercise price of $2.75 per share were granted to the underwriter and the placement agent associated with the offerings as consideration for the services provided, which provide for cash-less exercise.

At our annual meeting held on June 24, 2025, the stockholders approved an amendment to our Amended and Restated Certificate of Incorporation to increase our authorized shares of common stock from 50,000,000 to 100,000,000.

The amendment did not change any of the current rights and privileges of our common stock or its par value, and did not affect the number of shares of our common stock outstanding.

In December 2025, 482,290 investor warrants and 240,652 placement agent warrants issued in 2023, in connection with a public and private offering, were exercised.

In connection with the cashless exercise of the placement agent warrants, 68,356 shares were issued and 172,296 shares were withheld and canceled.

The exercise resulted in net proceeds to us of $1.3 million.

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 to us 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 to us 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.

Following completion of the July 2025 public offering, the underwriter exercised its over-allotment option 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 to us of $1.1 million, which included $0.1 million in offering expenses, such as underwriter fees, for net proceeds to us 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.

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.

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 year ended December 31, 2025, we sold an aggregate of 6,850,679 shares of common stock at an average selling price of $2.74 per share under the 2024 ATM Program, raising gross proceeds of $18.8 million, which included $0.7 million of sales commissions and other offering expenses for net proceeds to us of $18.1 million.

As of December 31, 2025, we have sold an aggregate of 8,447,807 shares of common stock at an average selling price of $2.60 per share under the 2024 ATM Program, raising gross proceeds of $21.9 million, which included $0.9 million of sales and commissions and other offering expenses for net proceeds to us of $21.0 million.

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 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.

As of December 31, 2025, 1,031,602 Pre-Funded Warrants were exercised resulting in the issuance of 1,031,602 shares of common stock.

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 cash-less exercise.

In the third quarter of 2024, we entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Oppenheimer & Co.

Inc., serving as agent (“Oppenheimer”) with respect to an at-the-market (“ATM”) offering program (the “2024 ATM Program”).

Under the 2024 ATM Program we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million.

We will pay Oppenheimer a commission equal to 3.0% of the gross sales proceeds of any shares sold through Oppenheimer under the Distribution Agreement.

During the year ended December 31, 2024, we sold an aggregate of 1,597,128 shares of our common stock at a weighted average price of $1.97 per share under the 2024 ATM Program, raising gross proceeds of $3.1 million, which included $0.2 million in sales commissions and other offering expenses.

From inception through December 31, 2024, we have raised an aggregate of $89 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.

The exercise of the over-allotment option resulted in gross proceeds of $0.46 million, which included $0.42 million of underwriting commissions and other expenses connected with the exercise of the option.

We also issued warrants to purchase 593,965 shares of common stock at an exercise price of $1.6875 per share to the underwriter as consideration for the services provided, and such warrants provide for cashless exercise.

From inception through December 31, 2025, we have raised an aggregate of $120 million of gross proceeds through equity financings, including the issuance of convertible preferred stock, our initial public offering, secondary offerings and previous sales under our ATM programs.

We have outstanding warrants for 5.8 million shares of our common stock at a weighted-average exercise price per share of $2.31 through December 31, 2025 related to public and private offerings.

Of the 5.8 million outstanding warrants, 5.4 million warrants are exercisable at a weighted-average exercise price per share of $2.34 as of December 31, 2025.

As of December 31, 2025, we had cash and cash equivalents of $20.8 million.

We have incurred recurring losses and negative cash flows from operations since inception and as of December 31, 2024 and December 31, 2023, had an accumulated deficit of $81.2 million and $60.8 million, respectively.

We have incurred recurring losses and negative cash flows from operations since inception and as of December 31, 2025 and 2024, had an accumulated deficit of $101.4 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.

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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.

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.

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Going Concern

As of December 31, 2024 and December 31, 2023, we had an accumulated deficit of $81.2 million and $60.8 million, respectively, and as of December 31, 2024, we had cash and cash equivalents of $10.4 million.

As of December 31, 2025 and 2024, we had an accumulated deficit of $101.4 million and $81.2 million, respectively, and as of December 31, 2025, we had cash and cash equivalents of $20.8 million.

During the year ended December 31, 2025, we incurred net losses of $20.2 million and negative cash flows from operations of $18.5 million.

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Our projected cash outflows for the upcoming periods raise substantial doubt about our ability to continue as a going concern for at least 12 months from the issuance of the financial statements included elsewhere in this Annual Report.

We will need to raise additional capital to fund continued operations beyond the third quarter of 2025.

We will need to raise additional capital to fund continued operations beyond the first quarter of 2027.

We plan to address our liquidity needs by taking steps to improve our operations and cash position, including identifying access to future capital and potential cost-reduction measures.

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Current Financing Environment

Until such time, if ever, as we can generate substantial product revenues to support our business and corporate strategy, we expect to finance our cash needs through a combination of public and private equity offerings, including an at-the-market offering, debt financings, government or private party grants, collaborations, strategic alliances and licensing arrangements.

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 at-the-market offerings, debt financings, government or private party grants, collaborations, strategic alliances and licensing arrangements.

We may not be able to obtain financing on acceptable terms, or at all, and we may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all.

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If we are unable to obtain funding, we could be required to delay, limit, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, or grant rights to develop, sell and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves, which could adversely affect our business prospects.

The war in Ukraine, the conflict between Hamas and Israel, global geopolitical tensions, and the post COVID-19 environment continue to have unpredictable impacts on global societies, economies, financial markets, and business practices.

Recently worsening global macroeconomic conditions, liquidity concerns at and failures of banks and other financial institutions, volatility in the capital markets, and related market uncertainty may impact our ability to obtain additional financing when needed on favorable terms or at all.

Uncertain macroeconomic conditions, including the risk of inflation, fluctuating interest rates, changing international trade and import policies, potential impact of tariffs, instability in the financial system, the war in Ukraine, global geopolitical tension, as well as rising healthcare costs continue to have unpredictable impacts on global societies, economies, financial markets, and business practices.

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.

Strategic Transactions;

Collaboration and Licensing Arrangement

In connection with our business development activities, we are continually looking to enter into collaboration and licensing arrangements with third parties to use our licensed Magellan™ computational platform technology to discover novel allosteric sites on proteins and identify proprietary small molecules that bind these sites and may be developed into pharmaceutical products.

We expect to continue to identify and evaluate collaboration, co-development and licensing opportunities that may be similar to or different from the collaboration and licenses arrangements that we have entered into.

We routinely evaluate business development opportunities for the advancement of our lead program, GT-02287, our earlier stage pipeline, and our Magellan TM computational platform technology, including potential licensing, co-development, commercialization, and other strategic alternatives.

These discussions may involve pharmaceutical companies, biotechnology companies, or other strategic partners.

While we continue to assess opportunities that could enhance shareholder value and support the advancement of our development programs, there can be no assurance that any such discussions will result in the execution of a definitive agreement.

We intend to pursue transactions that we believe align with our strategic objectives, strengthen our financial position, and accelerate the development and potential commercialization of our lead candidate.

Components of Our Consolidated Results of Operations

We have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future, if at all.

If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval and successfully commercialize them, we will not generate revenues in the future.

Historically, we have received limited collaboration revenue pursuant to a collaboration agreement with Zentalis Pharmaceuticals which concluded in the year ended December 31, 2023.

If we fail to complete the development of our product candidates in

a timely manner or fail to obtain their regulatory approval and successfully commercialize them, we will not generate revenues in the future.

Operating Expenses

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● expenses incurred under collaborations with third parties, including contract research organizations (“CROs”) and universities, that conduct research, preclinical and clinical studies, such as in-vitro and in-vivo absorption, distribution, metabolism and excretion (“ADME”), cell model studies, in-vivo pharmacology and pharmacokinetic studies, toxicology studies and chemical synthesis, stability studies, manufacturing and control materials, process characterization, scale-up and transfer, clinical trial expenses, on our behalf;

● employee salaries, benefits and other related costs, including share-based compensation expenses, for employees engaged in research and development functions and overhead allocations consisting of

various support and facilities-related expenses, which include rent, utilities and maintenance of our facilities, depreciation, travel and conference expenses;

● employee salaries, benefits and other related costs, including stock-based compensation expenses, for employees engaged in research and development functions and overhead allocations consisting of various support and facilities-related expenses, which include rent, utilities and maintenance of our facilities, depreciation, travel and conference expenses;

● fees paid to consultants who assist with research and development activities and related travel expenses;

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Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our financial statements as prepaid or accrued research and development expenses.

We anticipate that our research and development expenses will increase substantially in future periods to support progress in our research and development activities, including the progressing of the clinical trials for product candidates we are developing.

We anticipate that our research and development expenses will increase substantially in future periods to support progress in our research and development activities, including the progression of the clinical trials for product candidates we are developing.

These increases will likely also result from expanded infrastructure and increased insurance costs.

Such expenses are offset by contributions from research grants, which are recorded as a reduction to research and development expenses based on our best estimate of the periods in which the related expenditures are incurred and activities performed.

Such expenses are offset by contributions from research grants, which are recorded as a reduction to research and development expenses when we have reasonable assurance of collection and based on our best estimate of the periods in which the related expenditures are incurred and activities performed.

Our primary research and development focus since inception has been the application of our Magellan™ platform to various indications and targets, and more recently the development of our clinical stage lead product candidate GT-02287 for the treatment of Parkinson’s disease and other neurodegenerative diseases.

As of December 31, 2025 our efforts have led to the advancement of GT-02287 through Phase 1 testing and preparing to initiate Phase 2 clinical testing during third quarter of 2026.

Research and development activities are central to our business model.

Product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.

As a result, we expect that our research and development expenses will continue to 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.

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.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries, bonus and other related costs, including share-based compensation, for personnel in our executive, finance, corporate and business development and administrative functions.

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.

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Consolidated Results of Operations

The following table summarizes our results of operations for the years ended December 31, 2024 and December 31, 2023.

Collaboration revenues

Total revenues

The following table summarizes our results of operations for the years ended December 31, 2025 and 2024.

Operating expenses:

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Interest income, net

Foreign exchange gain (loss), net

Foreign exchange (loss) gain, net

Loss before income tax

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Comparison of the Years Ended December 31, 2025 and 2024

For the years ended December 31, 2024 and 2023, total revenues were nil and $55 thousand, respectively, and consisted mainly of income from a collaboration agreement with Zentalis Pharmaceuticals that ended as of December 31, 2023.

Research and development expenses

Research and development expenses decreased by $0.6 million to $10.2 million for the year ended December 31, 2025, as compared to $10.8 million for the year ended December 31, 2024.

The decrease in research and development expenses was primarily related to higher recognition of research grant income principally comprised of a tax credit for eligible research and development expenses in Australia.

These increases were partially offset by higher costs associated with the Clinical Phase 1 trial of our lead program compound GT-02287 for the treatment of Parkinson’s disease.

The decrease in research and development expenses was primarily related to optimization of our pipeline costs.

The decrease was partially offset by unfavorable foreign exchange currency translation as the Swiss franc strengthened against the U.S.

General and administrative expenses

General and administrative expenses decreased by $1.1 million to $8.5 million for the year ended December 31, 2025 from $9.6 million for the year ended December 31, 2024.

The decrease in general and administrative expenses was primarily attributable to lower personnel and stock-based compensation costs.

Foreign exchange gain (loss), net

Foreign exchange loss, net decreased by $0.5 million to a gain of $0.1 million for the year ended December 31, 2024 from a loss of $0.4 million for the year ended December 31, 2023.

The decrease was mainly attributable to favorable foreign exchange currency translation as the Swiss franc weakened against the U.S.

The decrease in general and administrative expenses was primarily attributable to lower stock-based compensation and lower legal fees.

The decrease was partially offset by higher personnel costs and unfavorable foreign exchange currency translation as the Swiss franc strengthened against the U.S.

Interest income, net

Interest income, net decreased by $0.1 million to $0.4 million for the year ended December 31, 2024 from $0.5 million for the year ended December 31, 2023.

The decrease was mainly attributable to lower interest income from treasury securities that reached maturity in April 2024.

Income taxes are $537 thousand and $79 thousand for the years ended December 31, 2024 and 2023, respectively.

Interest income, net decreased by $113 thousand to $244 thousand for the year ended December 31, 2025 from $357 thousand for the year ended December 31, 2024.

The decrease was 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 period.

Foreign exchange gain (loss), net

Foreign exchange loss, net increased by $953 thousand to a loss of $834 thousand for the year ended December 31, 2025 from a gain of $119 thousand for the year ended December 31, 2024 due to the unfavorable foreign currency exchange as the Swiss franc strengthened against the U.S.

Income taxes were $0.9 million and $0.5 million for the years ended December 31, 2025 and 2024, respectively.

The increase was mainly attributable to higher income taxes payable in Australia.

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As described in additional detail under “Financial Condition” above, we have funded our operations to date primarily through a combination of sales of our securities and research grants.

As of December 31, 2024 and December 31, 2023, we had $10.4 million in cash and cash equivalents and $16.8 million in cash, cash equivalents and marketable securities, respectively, and an accumulated deficit of $81.2 million and $60.8 million, respectively.

We had indebtedness of $0.4 million and $0.6 million as of December 31, 2024 and December 31, 2023, respectively.

Our cash and cash equivalents available at December 31, 2024 are expected to be sufficient to fund our anticipated operating and capital requirements into the third quarter of 2025 and will not be sufficient to finance our operations for one year from the issuance of the financial statements included in this Annual Report.

As of December 31, 2025 and 2024, we had $20.8 million and $10.4 million in cash and cash equivalents, respectively, and an accumulated deficit of $101.4 million and $81.2 million, respectively.

We had indebtedness of $0.4 million as of December 31, 2025 and 2024.

For the year ended December 31, 2025, we raised $7.0 million in net proceeds from our July 2025 public offering, $3.2 million in net proceeds from the exercise of warrants, and $18.1 million in net proceeds under the 2024 ATM Program.

Our cash and cash equivalents available at December 31, 2025 are expected to be sufficient to fund our anticipated operating and capital requirements into the first quarter of 2027 and will not be sufficient to finance our operations for one year from the issuance of the financial statements included in this Annual Report.

Therefore, we have reported that there is substantial doubt about our ability to continue as a going concern.

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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.

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.

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, at-the-market offerings, government or private party grants, collaborations, strategic alliances, and licensing arrangements.

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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.

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Effect of exchange rate changes

Net (decrease)/increase in cash, cash equivalents and restricted cash

Net increase (decrease) in cash, cash equivalents and restricted cash

Cash Flows from Operating Activities

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

During the years ended December 31, 2025 and 2024, we used $18.5 million and $18.9 million, respectively of cash in operating activities, primarily to fund our operations related to the development of our pipeline and product candidates as well as related general and administrative support activities.

Cash Flows from Investing Activities

During the year ended December 31, 2024, net cash provided by investing activities was $5.0 million, primarily due to the maturity of marketable securities.

During the year ended December 31, 2023, net cash provided by investing activities was $10.2 million, primarily due to the maturity of marketable securities for $12.2 million partially offset by the purchase of marketable securities for $2.0 million.

Cash Flows from Financing Activities

During the year ended December 31, 2025, cash provided by financing activities was $28.4 million which consisted of the following:

$7.4 million of net proceeds from the issuance of shares in the July 2025 public offering, $18.1 million of net proceeds from the issuance of shares pursuant to the 2024 ATM Program, $3.5 million provided by the exercise of stock options and public warrants, partially offset by $0.4 million payment of offering costs and $0.1 million repayment of long-term debt.

During the year ended December 31, 2024, cash provided by financing activities was $13.0 million primarily related to the following:

$10.3 million provided by net proceeds from the issuance of shares and warrants in the public offering, $3.0 million provided by net proceeds from issurance of shares in the ATM offering, $0.2 million provided by the exercise of stock options and public warrants, partially offset by $0.3 million payment of offering costs and $0.1 million repayment of long-term debt.

During the year ended December 31, 2023, cash provided by financing activities was $12.6 million mainly related to the net proceeds from the public offering and the concurrent private placement for $9.2 million, and the net proceeds related to the issurance of shares in the ATM offering of $3.5 million.

$10.3 million provided by net proceeds from the issuance of shares and warrants in the public

offering, $3.0 million provided by net proceeds from issuance of shares pursuant to the 2024 ATM Program, $0.2 million provided by the exercise of stock options and public warrants, partially offset by $0.3 million payment of offering costs and $0.1 million repayment of long-term debt.

Funding Requirements

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Our future funding requirements will depend on many factors, including, but not limited to:

● the number and characteristics of the product candidates we pursue;

● the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates;

● costs associated with growing our workforce;

● the scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates;

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Because of the numerous risks and uncertainties associated with the development of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, including at-the-market offerings, debt financings, government or private party grants, collaborations, strategic alliances and licensing arrangements.

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.

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generally accepted accounting principles.

The preparation of these 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.

The preparation of these consolidated financial statements and related disclosures require us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements.

We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, defined benefit pension liability, share-based compensation, recognition of research grants and the going concern assessment.

On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, defined benefit pension liability, stock-based compensation, warrants, recognition of research grants and the going concern assessment.

Our actual results may differ from these estimates under different assumptions or conditions.

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The overfunded or underfunded status of the defined benefit plans is calculated as the difference between plan assets and the projected benefit obligations.

Estimates are used in determining the assumptions incorporated in the calculation of the pension obligations, which is supported by input from independent actuaries.

Estimates are used in determining the assumptions incorporated in the calculation of the pension obligations, which are supported by input from independent actuaries.

Actuarial gains and losses arising from experience adjustments and changes in actuarial assumptions are recognized in “Accumulated Other Comprehensive Income (Loss)” in the Consolidated Statements of Changes in Stockholders’ Equity and are charged or credited to income over the employees’ expected average remaining working lives.

The measurement date used for our employee defined benefit plan is December 31 st .

Share-based compensation

We recognize compensation costs related to share-based compensation granted to employees, consultants, and directors based on the estimated fair value of the awards as of the grant date.

We estimate the grant date fair value and the resulting share-based compensation using the Black-Scholes option-pricing model for stock option awards.

Stock-based compensation

We recognize compensation costs related to stock-based compensation awards granted to employees, consultants, and directors based on the estimated fair value of the awards as of the grant date.

We estimate the grant date fair value and the resulting stock-based compensation using the Black-Scholes option-pricing model for stock option awards.

The grant date fair value of the stock option awards is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards.

We estimate the fair value of stock options using the Black-Scholes option-pricing model, which requires assumptions, including volatility, the expected term of exercise, the risk free interest rate for a period that approximates the expected term of exercise, and our expected dividend yield.

Certain assumptions used in our Black-Scholes option-pricing model represent management’s best estimates and involve a number of assumptions and the application of management’s judgment, as they are inherently subjective.

Certain assumptions used in our Black-Scholes option-pricing model represent

management’s best estimates and involve a number of assumptions and the application of management’s judgment, as they are inherently subjective.

We recognize expenses related to Restricted Stock Units (or RSUs) based on their fair market value, determined as the closing price on the Nasdaq of our common stock as of the grant date, on a straight-line basis over the requisite service period.

For restricted stock units with market or performance based vesting conditions (or PRSUs), the fair value at grant date is calculated using an option-pricing model (Monte Carlo Simulation) or based on management’s assessment of the likelihood of occurrence of the underlying performance.

We account for warrants to purchase shares of our common stock as equity instruments.

We evaluate each warrant at issuance to determine the appropriate classification.

Warrants that are indexed to our own common stock and meet the criteria for equity classification are recorded at fair value as of the issuance date within stockholders' equity and are not subsequently remeasured.

The Black-Scholes option pricing model is also used for the warrants issued, using consistent inputs and methodology to quantify such inputs, as described above in relation to stock-based compensation.

Certain assumptions used in our Black-Scholes option-pricing model represent management's best estimates and involve the application of management's judgment, as they are inherently subjective.

Research grants

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The tax credits are administered through the local tax authority and can be realized regardless of whether we have generated taxable income in the respective jurisdictions.

are classified in the Consolidated Statements of Operations as a reduction to research and development expenses when collectability is reasonably assured.

The tax credits are based on a percentage of eligible research and development activities under the program and are recorded based on management’s best estimate of the periods in which the related expenditures are incurred and activities performed and are classified in the Consolidated Statements of Operations as a reduction to research and development expenses when collectability is reasonably assured.

Going concern assessment

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The assessment over going concern is based on management’s most updated budget and forecast and does not take into consideration estimated future cash inflows that are not certain as of the date of preparation of the financial statements.

Please refer to the discussion above titled “Going Concern”.

Jumpstart Our Business Startups (“JOBS”) Act

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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.

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.

We will remain an emerging growth company until the earliest of (i) the last day of our first fiscal year in which we have total annual gross revenue of $1.235 billion or more, (ii) December 31, 2026, (iii) the date on which we have issued more than $1.0 billion of non-convertible debt instruments during the previous three fiscal years or (iv) the date on which we are deemed a “large accelerated filer” under the rules of the SEC with at least $700 million of outstanding equity securities held by non-affiliates.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis