What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-02-26 compared with 2025-02-27 · 106 added, 56 removed, 115 unchanged (58% of the section changed)

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“Risk Factors.”

Our discussion and analysis of our financial condition and results of operations for 2025 as compared to 2024 are discussed below and should be read in conjunction with our audited Consolidated Financial Statements, including the notes thereto.

For a discussion of our financial condition and results of operations for 2024 as compared to 2023, except as set forth below, please refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2024 Annual Report on Form 10-K , which discussion is incorporated by reference herein.

We are a clinical stage global biopharmaceutical company developing novel oral small molecule therapeutics to treat a wide range of chronic diseases with unmet medical need.

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For more information, please see section in Part 1.

Our most advanced product candidate to date is aleniglipron, also known as GSBR-1290, an oral small molecule selective glucagon-like-peptide-1 receptor (“GLP-1R”) agonist currently in five ongoing clinical studies for the treatment of obesity, overweight and related conditions.

We have two oral small molecule amylin receptor agonists:

ACCG-2671 which is currently in Phase 1 clinical development and ACCG-3535, which we have selected as our second amylin development candidate.

Our obesity pipeline also includes multiple preclinical discovery stage small molecules targeting glucose-dependent insulinotropic polypeptide and glucagon receptors.

Importantly, these programs have the potential to be developed as monotherapy as well as in fixed dose combination with our backbone GLP-1 or amylin development candidates.

These combination products enable us to potentially address diseases beyond obesity including type 2 diabetes mellitus, heart failure, sleep apnea, chronic kidney disease, osteoarthritis, metabolic dysfunction-associated steatotic liver disease and potentially even addiction and Parkinson’s disease and Alzheimer’s disease, areas where we are starting to see encouraging data with GLP-1Rs.

Our product candidates, as oral small molecules, have the potential to be more accessible medicines than biologics and peptide therapies with potentially differentiated efficacy and safety and, from a manufacturing standpoint, more scalable to meet global demand.

We outsource clinical drug manufacturing, storage, distribution and quality testing to third-party manufacturers.

We believe this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment and personnel while also enabling us to focus our expertise and resources on the design and development of our product candidates.

We have established a manufacturing plan in the United States and continue to contract in parallel with additional suppliers in the United States and other regions outside of China to diversify the manufacturing of our active pharmaceutical ingredient and drug product.

pharmaceutical ingredient and drug product.

As our development programs progress and we build new process efficiencies, we expect to continually evaluate this strategy with the objective of satisfying demand for registration studies and, if approved, the manufacture, sale and distribution of commercial products.

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Since our inception, we have incurred net operating losses and negative cash flows from operations.

We had net losses of $122.5 million and $89.6 million in the years ended December 31, 2024 and 2023, respectively.

We had net losses of $141.2 million, $122.5 million and $89.6 million in the years ended December 31, 2025, 2024 and 2023, respectively.

As of December 31, 2025, we had an accumulated deficit of $470.3 million.

Historically, we have financed our operations primarily through the private placement of equity securities.

In February 2023, we completed our initial public offering (“IPO”) of our American depositary shares (“ADSs”), in which we issued and sold an aggregate of 12,351,000 ADSs (inclusive of 1,611,000 ADSs purs uant to the exercise by the underwriters of their option) at a price of $15.00 per ADS for net cash proceeds of approximately $ 166.7 million, net of underwriting discounts and commissions and estimated offering costs.

Upon the closing of the IPO, all outstanding shares of redeemable convertible preferred shares automatically converted into 67,018,087 ordinary shares.

Subsequent to the closing of the IPO, there were no shares of

redeemable convertible preferred shares outstanding.

In September 2023, we entered into a share purchase agreement with certain institutional investors (the “Purchasers”), pursuant to which we agreed to sell and issue to the Purchasers an aggregate of 21,617,295 ordinary shares and 2,401,920 newly designated non-voting ordinary shares at a purchase price of $12.49 per share (or the equivalent of $37.47 per ADS), the closing price of our ADS on the Nasdaq Global Market on September 28, 2023 (the “Private Placement”).

We completed the Private Placement in October 2023 and received approximately $281.5 million in net proceeds after deducting placement agent fees and other private placement expenses.

In June 2024, we issued and sold 10,427,017 ADSs, including the full exercise of the underwriters’ option to purchase additional shares, and received $512.7 million in net proceeds, after deducting the underwriting discounts and commissions and estimated offering expenses (the “Follow-On Offering”).

Historically, prior to our IPO, we have financed our operations primarily through the private placement of equity securities.

As of December 31, 2025, we have cash, cash equivalents and short-term investments of $1,446.2 million.

Based on our current business plan, we estimate that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations and key clinical milestones through at least 2027, including all aleniglipron studies for Phase 3 readiness but excluding Phase 3 registrational studies.

This includes costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension study, the supplementary studies, and Phase 3 registrational program in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing.

We have based this estimate on assumptions that may prove to be wrong, and we may exhaust our available capital resources sooner than we expect.

We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, particularly if and as we continue to invest in our research and development activities and initiate additional clinical studies, expand our product pipeline, hire additional personnel and invest in and grow our business, maintain, expand and protect our intellectual property portfolio, and seek regulatory approvals for and commercialize any approved product candidates.

In addition, we have incurred and expect to continue to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory, consulting, and tax-related services associated with being a public company, compliance with Nasdaq listing and SEC requirements, director and officer insurance premiums and investor relations costs that we did not incur as a private company.

As a result, we will need substantial additional capital to develop our product candidates, including to fund Phase 3 clinical studies of aleniglipron, and fund operations for the foreseeable future.

Moreover, we may in the future seek to acquire or invest in additional businesses, products, or technologies that we believe could complement or enhance our products, enhance our technical capabilities or otherwise offer growth opportunities, although we currently have no agreements or understandings with respect to any such acquisitions or investments.

Until such time as we can generate significant revenue from our products, if ever, we expect to finance our operations through the public or private sale of equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions.

If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations.

If we raise funds through strategic collaborations or other similar arrangements with third-parties, we may have to relinquish valuable rights to our platform technology, future revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our ordinary shares.

Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability.

Impact of Geopolitical and Macroeconomic Factors

and China, the ongoing Russia/Ukraine conflict and the Israel-Hamas war for the year ended December 31, 2024, there may be potential impacts to our business in the future that are highly uncertain and difficult to predict, including our ability to raise additional funds, disruptions to the supply chain and the manufacture or shipment of drug substances and finished drug products for our product candidates for use in our research, preclinical studies and clinical studies, impediments to our clinical trial initiation and recruitment, errors or omissions at our clinical sites and the ability of patients to continue in clinical studies, delays in the FDA’s review and approval processes, our ability to effectively operate across different geographies in which our offices are located, continued increases in interest rates and economic inflation, bank failures, the impact on the global economy due to the Russia/Ukraine conflict and Israel-Hamas war, higher prices of supplies, and changes in availability and cost of credit and our ability to access capital.

Although we did not see a significant financial impact to our business operations as a result of recent geopolitical and macroeconomic developments, such as recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures, tariffs, global pandemics, geopolitical tensions between the United States and China, and various global conflicts for the year ended December 31, 2025, there may be potential impacts to our business in the future that are highly uncertain and difficult to predict, including our ability to raise additional funds, disruptions to the supply chain and the manufacture or shipment of drug substances and finished drug products for our product candidates for use in our research, preclinical studies and clinical studies, impediments to our clinical trial initiation and recruitment, errors or omissions at our clinical sites and the ability of patients to continue in clinical studies, delays in the FDA’s review and approval processes including as a result of recent layoffs, our ability to effectively operate across different geographies in which our offices are located, any increases in interest rates and economic inflation, bank failures, the impact on the global economy due to various global conflicts, higher prices of supplies, tariffs, changes in monetary and fiscal policy, U.S.

political developments and other sources of instability and changes in availability and cost of credit and our ability to access capital.

The ultimate impact of these geopolitical and macroeconomic factors, as well as any lasting effects on the way we conduct our business, is highly uncertain and subject to continued change, and we recognize that they may continue to present unique challenges for us.

On July 4, 2025, the annual reconciliation bill, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, introducing significant changes to U.S.

federal tax law.

The new law repeals the requirement to capitalize domestic research and development (“R&D”) expenditures for federal income tax purposes for taxable years beginning after December 31, 2024, and allows for the accelerated deduction of any remaining unamortized domestic R&D expenditures.

Foreign R&D expenditures are still required to be capitalized and amortized ratably over 15 years.

The law also permanently allows one hundred percent bonus depreciation for qualified business property, including machinery, equipment, and certain improvements to nonresidential real property.

Components of Our Results of Operations

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We are focusing substantially all of our resources on the development of our product candidates and the discovery of new product candidates through our structure-based drug discovery platform.

At this time, we

cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates.

At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates.

We expect our research and development expenses to continue to account for a significant portion of our operating expenses, and to increase substantially for the foreseeable future as we advance our product candidates into and through preclinical and clinical studies, identify new product candidates and potentially pursue regulatory approval of our product candidates.

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We expect our general and administrative expenses will increase during the next several years as we increase our headcount and expand our infrastructure to support our operations, particularly as a public company.

In addition, as a public company, we have incurred and will continue to incur significant legal, accounting, investor relations and other expenses to comply with the reporting requirements of the Exchange Act, the listing standards of Nasdaq, the Sarbanes-Oxley Act, and other applicable securities rules and regulations.

In addition, as a public company, we have incurred and will continue to incur significant legal, accounting, investor relations and other expenses to comply with the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the listing standards of Nasdaq, the Sarbanes-Oxley Act, and other applicable securities rules and regulations.

Our general and administrative expenses may fluctuate from period to period as we continue to grow.

Interest and Other Income (Expense), Net

Interest and other income (expense), net primarily consists of interest income earned on our cash, cash equivalents and short-term investments, including amortization and accretion of premiums and discounts on short-term investments, foreign currency exchange gains and losses and interest expense for the amortization of debt issuance costs.

Other License Income

Other license income consists of income from a non-exclusive license of certain patents granted under the Genetech Agreement.

For more detail on our other license income, refer to Note 8 to our consolidated financial statements included in Part II.

Item 8 “Financial Statements and Supplementary Data” of this Annual Report.

Gains on Sale of Non-financial Assets

Gains on sale of non-financial assets consists of the gain on sale of certain patents under the Exelixis Agreement.

For more detail on our gains on sale of non-financial assets, refer to Note 9 to our consolidated financial statements included in Part II.

Item 8 “Financial Statements and Supplementary Data” of this Annual Report.

Interest and Other Income, Net

Interest and other income, net primarily consists of interest income earned on our cash, cash equivalents and short-term investments, including amortization and accretion of premiums and discounts on short-term investments, and foreign currency exchange gains and losses.

Results of Operations

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General and administrative

Other license income

Gains on sale of non-financial assets

Total operating expenses

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Research and development expenses increased by $116.4 million, or 107%, to $225.3 million during the year ended December 31, 2025, compared to $108.8 million during the year ended December 31, 2024.

The increase in research and development expenses was primarily due to increases related to increases in personnel-related expenses due to an increase in headcount, an increase in research and development expenses and consulting services to support the advancement of our GLP-1R franchise including alenigripron (GSBR-1290) and an increase in the allocation of facilities costs.

The increase in research and development expenses was primarily due to increases related to clinical trial costs, preclinical research and development expenses, employee expenses (primarily due to an increase in personnel) and a milestone payment under our Aconcagua-Schrödinger Agreement.

The following table summarizes our research and development expenses for the periods indicated (in thousands):

Product candidate:

Alenigripron (GSBR‑1290)

Aleniglipron (GSBR‑1290)

Total research and development expenses

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General and administrative expenses increased by $12.1 million, or 25%, to $61.6 million during the year ended December 31, 2025, compared to $49.4 million during the year ended December 31, 2024.

The increase in general and administrative expenses was primarily due to increases in personnel-related expenses and professional services as we expanded our infrastructure to drive and support the growth in our operations as a publicly-traded company.

Interest and Other Income (Expense), Net

Interest and other income (expense), net, increased by $22.6 million to an income of $36.0 million during the year ended December 31, 2024, compared to an income of $13.4 million during the year ended December 31, 2023.

The increase in interest and other income (expense), net, was primarily due to an increase in interest income from higher cash, cash equivalents and short-term investment balances.

The increase in general and administrative expenses was primarily due to increases in employee expenses as we expanded our infrastructure to drive and support the growth in our operations as a publicly-traded company.

Other License Income

Other license income was $100.0 million during the year ended December 31, 2025, consisting of a $100.0 million income from the license of certain patents that cover a class of oral GLP-1 receptor agonists that is different from aleniglipron under the Genentech Agreement.

We did not have similar agreements during the year ended December 31, 2024.

For more detail on our other license income, refer to Note 8 to our consolidated financial statements included in Part II.

Item 8 “Financial Statements and Supplementary Data” of this Annual Report.

Gains on Sale of Non-financial Assets

Gains on sale of non-financial assets was $10.2 million during the year ended December 31, 2025, consisting of a $10.2 million gain on the sale of certain early-stage non-metabolic and non-obesity assets under the Exelixis Agreement.

We did not have similar agreements during the year ended December 31, 2024.

For more detail on our gains on sale of non-financial assets, refer to Note 9 to our consolidated financial statements included in Part II.

Item 8 “Financial Statements and Supplementary Data” of this Annual Report.

Interest and Other Income, Net

Interest and other income, net, decreased by $0.1 million to an income of $35.9 million during the year ended December 31, 2025, compared to an income of $36.0 million during the year ended December 31, 2024.

The decrease in interest and other income, net, was primarily due to a decrease in interest income from lower interest rates, partly offset by an increase in interest income from higher cash, cash equivalents and short-term investment balances.

Liquidity and Capital Resources

Sources of Funds

Initial Public Offering

From our reorganization as a Cayman Islands exempted company in February 2019 through immediately prior to completion of our IPO, we funded our operations primarily with an aggregate of $198.0 million in gross cash proceeds from the sale of redeemable convertible preferred shares.

In February 2023, we completed our IPO and received $166.7 million in net proceeds after deducting underwriting discounts and commissions and estimated offering costs.

In October 2023, we completed our Private Placement and received $281.5 million in net proceeds after deducting placement agent fees and other private placement expenses.

In June 2024, we closed our Follow-On Offering and received $512.7 million in net proceeds after deducting the underwriting discounts and commissions and estimated offering expenses.

In connection with the closing of our IPO in February 2023, we issued and sold an aggregate of 12,351,000 American Depositary Shares (“ADSs”) (inclusive of 1,611,000 ADSs pursuant to the exercise by the underwriters of their option) at a price of $15.00 per ADS for net cash proceeds of approximately $166.7 million, net of underwriting discounts and commissions and estimated offering costs.

Private Placement

We completed the Private Placement in October 2023 and received approximately $281.5 million in net proceeds after deducting placement agent fees and other private placement expenses.

2024 Follow-On Offering

In June 2024, we issued and sold 10,427,017 ADSs at a price of $52.50 per ADS, including the full exercise of the underwriters’ option to purchase up to an aggregate of 1,360,045 additional ADSs, and received $512.7 million in net proceeds, after deducting the underwriting discounts and commissions and estimated offering expenses (the “2024 Follow-On Offering”).

At-the-Market Offering

In August 2025, we entered into a sales agreement (the “ATM Sales Agreement”) with Leerink Partners LLC and Cantor Fitzgerald & Co.

(the “ATM Sales Agents”), pursuant to which we may, from time to time, offer and sell our ADSs through the ATM Sales Agents in any manner deemed to be an “at-the-market” offering up to an aggregate offering price of $250.0 million (the “ATM Offering”).

In September 2025, we sold 3,040,000 ADSs under the ATM Sales Agreement, for gross proceeds of approximately $58.5 million.

The net proceeds after deducting sales commissions to the ATM Sales Agents were approximately $57.1 million, and, after further deducting offering expenses were approximately $55.8 million.

2025 Follow-On Offering

In December 2025, we issued and sold (i) 9,961,538 ADSs, including the issuance of 1,500,000 ADSs in connection with the full exercise of the underwriters’ option, and (ii) in lieu of ADSs to certain investors, pre-funded warrants to purchase ordinary shares represented by 1,538,462 ADSs (the “Pre-Funded Warrants”) at a price of $64.9999 per Pre-Funded Warrant, which represents the per ADS public offering price less the $0.0001 per share exercise price for each such Pre-Funded Warrant.

We received $701.5 million in net proceeds, after deducting the underwriting discounts and commissions and estimated offering expenses (the “2025 Follow-On Offering”).

As of December 31, 2025, we had cash, cash equivalents and short-term investments of $1,446.2 million and an accumulated deficit of $470.3 million.

Funding Requirements

Prior to our IPO, we financed our operations primarily through the private placement of equity securities and have received aggregate gross proceeds of approximately $198.0 million.

Since our inception, we have incurred net operating losses and negative cash flows from operations.

We had net losses of $122.5 million and $89.6 million in the years ended December 31, 2024 and 2023, respectively.

We had net losses of $141.2 million, $122.5 million and $89.6 million in the years ended December 31, 2025, 2024 and 2023, respectively.

As of December 31, 2025, we had an accumulated deficit of $470.3 million.

In February 2023, we completed our IPO for net proceeds of $166.7 million.

In October 2023, we completed our Private Placement and received $281.5 million in net proceeds after deducting placement agent fees and other private placement expenses.

In June 2024, we closed our Follow-On Offering and received $512.7 million in net proceeds after deducting the underwriting discounts and commissions and estimated offering expenses.

Our primary activities to date have included organizing and staffing our company, business and scientific planning, raising capital, conducting research and development activities, entering into strategic and corporate structuring transactions, enabling manufacturing activities in support of our product candidate development efforts, establishing our intellectual property portfolio, and providing general and administrative support for these activities.

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In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory, tax-related, director and officer insurance, investor relations and other expenses that we did not incur as a private company.

Moreover, we may in the future seek to acquire or invest in additional businesses, products, or technologies that we believe could complement or enhance our product, enhance our technical capabilities or otherwise offer growth opportunities, although we currently have no agreements or understandings with respect to any such

acquisitions or investments.

In addition, we have incurred and expect to continue to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory, tax-related, director and officer insurance, investor relations and other expenses that we did not incur as a private company.

We are subject to the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

We will need substantial additional capital to develop our product candidates and fund operations for the foreseeable future.

We will need substantial additional capital to develop our product candidates, including to fund Phase 3 clinical studies of aleniglipron, and fund operations for the foreseeable future.

Our future capital requirements will depend on many factors, including:

● the scope, timing, rate of progress and costs of our preclinical development activities, laboratory testing and clinical studies for our product candidates, including to fund Phase 3 clinical studies of aleniglipron;

● the scope, timing, rate of progress and costs of our preclinical development activities, laboratory testing and clinical studies for our product candidates;

● the number and scope of clinical programs we decide to pursue;

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● our implementation of operational, financial and management systems;

● the impact of geopolitical and macroeconomic events, including future bank failures, tariffs, increased geopolitical tensions between the U.S.

and China, the Russia/Ukraine conflict, the Israel-Hamas war and global pandemics on U.S.

and global economic conditions that may impact our ability to access capital on acceptable terms, if at all.

● the impact of geopolitical and macroeconomic events, including tariffs, future bank failures, increased geopolitical tensions between the United States and China, various global conflicts and global pandemics on U.S.

and global economic conditions including changes in monetary and fiscal policy, tax laws, U.S.

political developments and other sources of instability that may impact our ability to access capital on acceptable terms, if at all.

A change in the outcome of any of these or other variables with respect to the development of our product candidates could significantly change the costs and timing associated with the development of that product candidate.

Furthermore, our business plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such plans.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the public or private sale of equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions.

Until such time we can generate significant revenue from product sales, if ever, we expect to finance our operations through the public or private sale of equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be diluted, and the terms of these securities may include liquidation or other preferences and anti-dilution protections that could adversely affect your rights as a holder of our ADSs.

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If we are unable to obtain additional funding, or funding on acceptable terms, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations.

any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations.

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Cash Flows Used in Operating Activities

During the year ended December 31, 2025, net cash used in operating activities was $222.2 million, consisting of a net loss of $141.2 million, an increase in net operating assets of $88.0 million, partially offset by non-cash charges of $7.0 million.

The increase in net loss was primarily due to the increase in operating expenses as we invest in our research and development efforts.

The increase in net operating assets was primarily due to an increase in prepaid expenses and other current assets and a decrease in operating lease liabilities, partially offset by an increase in accrued expenses and other current liabilities, an increase in accounts payable and a decrease in other non-current assets.

Non-cash charges consisted primarily of share-based compensation and non-cash lease expense, partially offset by net gain from accretion of net investment discounts and gain on sale of non-financial assets.

During the year ended December 31, 2024, net cash used in operating activities was $116.6 million, consisting primarily of a net loss of $122.5 million, partially offset by non-cash charges of $2.9 million and a decrease in net operating assets of $3.0 million.

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The decrease in net operating assets was primarily due to an increase in accrued expenses and other current liabilities and accounts payable, partially offset by an increase in prepaid expenses and other current assets, an increase in other non-current assets and a decrease in operating lease liabilities.

During the year ended December 31, 2023, net cash used in operating activities was $79.5 million, consisting primarily of a net loss of $89.6 million, partially offset by non-cash charges of $3.2 million and a decrease in net operating assets of $7.0 million.

The increase in net loss was primarily due to the increase in operating expenses as we invest in our research and development efforts and operate as a publicly-traded company.

Non-cash charges consisted primarily of share-based compensation, partially offset by net gain from accretion of net investment discounts.

The decrease in net operating assets was primarily due to an increase in accrued expenses and other current liabilities, partially offset by an increase in prepaid expenses and other current assets.

Cash Flows Used in Investing Activities

During the year ended December 31, 2024, net cash used in investing activities was $358.9 million, consisting primarily of net purchases of short-term investments.

Cash Flows Provided by (Used in) Investing Activities

During the year ended December 31, 2025, net cash provided by investing activities was $89.8 million, consisting primarily of net maturities of short-term investments of $83.2 million, and proceeds from sale of non-financial asset of $10.2 million.

During the year ended December 31, 2024, net cash used in investing activities was $358.9 million, consisting primarily of net purchases of short-term investments.

Cash Flows Provided by Financing Activities

During the year ended December 31, 2025, net cash provided by financing activities was $762.5 million, consisting primarily of proceeds from our 2025 Follow-On Offering of $702.7 million, net of underwriting discounts and commissions and from sales of our ADSs under the ATM Offering of $57.1 million, net of sales commissions.

During the year ended December 31, 2024, net cash provided by financing activities was $515.3 million, consisting primarily of proceeds from our 2024 Follow-On Offering of $514.6 million, net of underwriting discounts and commissions.

During the year ended December 31, 2023, net cash provided by financing activities was $451.5 million, consisting primarily of proceeds from our IPO of $172.3 million, net of underwriting discounts and commissions, and gross proceeds from our Private Placement of $300.0 million, partially offset by payments of offering costs of $21.6 million.

Contractual Obligations

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Item 8 “Financial Statements and Supplementary Data” of this Annual Report.

Accrued Research and Development Expenses

We have entered into various agreements with contract manufacturing organizations (“CMOs”) and CROs.

Our research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs.

The estimated costs of research and development provided, but not yet invoiced, are included in other current liabilities on the balance sheets.

If the actual timing of the performance of services or the level of effort varies from the original estimates, we will adjust the accrual accordingly.

Payments made to CMOs and CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets on the balance sheets until the services are rendered.

To date, our estimated accruals have not differed materially from the actual costs.

Accrued Research and Development and Clinical Expenses

We have entered into various agreements with contract manufacturing organizations (“CMOs”) and contract research organizations (“CROs”).

Our research and development and clinical accruals are determined based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs.

Accruals for CROs and CMOs are recorded based on services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers.

We determine our costs through discussions with internal clinical stakeholders and outside service providers as to the progress or stage of completion of clinical studies or services and the contracted fee to be paid for such services.

The determined costs of research and development and clinical studies provided, but not yet invoiced, are included in accrued expenses and other current liabilities on the consolidated balance sheets.

If the actual timing of the performance of services or the level of effort varies from the original amounts, we will adjust the accrual accordingly.

We make judgements in determining the accrual balance in each reporting period.

Payments made to CMOs and CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets on the consolidated balance sheets and subsequently recognized as research and development expense when the associated services have been performed.

As actual costs become known, we adjust our liabilities and assets.

Inputs used in our determination of costs discussed above may vary from actual, which will result in adjustments to research and development expense in future periods.

To date, our accruals have not differed materially from the actual costs.

Recent Accounting Pronouncements

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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