MeiraGTx Holdings plc

Previous wording

We are a vertically integrated, clinical-stage gene therapy company with a broad pipeline of late-stage clinical programs supported by end-to-end manufacturing capabilities. We have an internally developed manufacturing platform process, internal plasmid production for good manufacturing practices, or GMP, two GMP viral vector production facilities as well as an in-house Quality Control hub for stability and release, all fit for IND through commercial supply. We have core capabilities in viral vector design and optimization and a potentially transformative riboswitch gene regulation platform technology that allows for the precise, dose-responsive control of gene expression by oral small molecules. We are focusing the riboswitch platform on delivery of metabolic peptides including GLP-1, GIP, glucagon and PYY using oral small molecules, as well as cell therapy for oncology and autoimmune diseases. Although initially focusing on the eye, central nervous system, and salivary gland, we have developed the technology to apply genetic medicine to more common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains great. We are an exempted company incorporated under the laws of the Cayman Islands in 2018, and prior to that, we commenced operations as MeiraGTx Limited, a private limited company incorporated under the laws of England and Wales in 2015. Our discussion of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Since our formation, we have devoted substantially all of our resources to developing our technology platform, establishing our viral vector manufacturing facilities and our GMP plasmid and DNA production facility and developing manufacturing processes, advancing the product candidates in our ophthalmology, salivary gland and neurodegenerative disease programs, building our intellectual property portfolio, organizing and staffing our Company, developing our business plan, raising capital, and providing general and administrative support for these operations. To date, we have financed our operations primarily with cash on hand, proceeds from the sales of our Series A ordinary shares, convertible preferred C shares and ordinary shares, debt financing and upfront and milestone payments in connection with the Collaboration, Option and License Agreement with Janssen Pharmaceuticals, Inc. (“Janssen”), one of the Janssen Pharmaceuticals Companies of Johnson & Johnson, dated as of January 30, 2019 (the “Collaboration Agreement”), which also provided us with research funding, and the Asset Purchase Agreement, dated as of December 20, 2023, we entered into with Janssen (the “Asset Purchase Agreement”) pursuant to which we sold and assigned to Janssen, and Janssen purchased and assumed, that certain License Agree…

Excerpt shortened here; the source contains the full paragraph.

Current wording

We are a vertically integrated, clinical-stage genetic medicines company with a broad pipeline of late-stage clinical programs supported by end-to-end manufacturing capabilities. We have an internally developed manufacturing platform process, internal plasmid production for good manufacturing practices, or GMP, two GMP viral vector production facilities as well as an in-house Quality Control hub for stability and release, all fit for IND through commercial supply. We have core capabilities in viral vector design and optimization and a potentially transformative riboswitch gene regulation platform technology that allows for the precise, dose-responsive control of gene expression by oral small molecules. We are focusing the riboswitch platform on delivery of metabolic peptides including GLP-1, GIP, glucagon and PYY using oral small molecules, as well as cell therapy for oncology and autoimmune diseases. Although initially focusing on the eye, central nervous system, and salivary gland, we have developed the technology to apply genetic medicine to more common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains great. We are an exempted company incorporated under the laws of the Cayman Islands in 2018, and prior to that, we commenced operations as MeiraGTx Limited, a private limited company incorporated under the laws of England and Wales in 2015. Our discussion of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Since our formation, we have devoted substantially all of our resources to developing our technology platform, establishing our viral vector manufacturing facilities and our GMP plasmid and DNA production facility and developing manufacturing processes, advancing the product candidates in our ophthalmology, salivary gland and neurodegenerative disease programs, building our intellectual property portfolio, organizing and staffing our Company, developing our business plan, raising capital, and providing general and administrative support for these operations. To date, we have financed our operations primarily with cash on hand, proceeds from the sales of our Series A ordinary shares, convertible preferred C shares and ordinary shares, debt financing and upfront and milestone payments in connection with the Collaboration, Option and License Agreement with Johnson & Johnson Innovative Medicine (formerly known as Janssen Pharmaceuticals, Inc.), dated as of January 30, 2019 (the “Collaboration Agreement”), which also provided us with research funding, and the Asset Purchase Agreement, dated as of December 20, 2023, we entered into with Johnson & Johnson Innovative Medicine (the “Asset Purchase Agreement”) pursuant to which we sold and assigned to Johnson & Johnson Innovative Medicine, and Johnson & Joh…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

We are a clinical stage company and have not generated any product revenues to date. We have ongoing clinical development programs and a broad pipeline of preclinical programs. Since inception, we have incurred significant operating losses. Our net losses for the three-month periods ended March 31, 2024 and 2023 were $20.4 million and $30.4 million, respectively. As of March 31, 2024, we had an accumulated deficit of $574.7 million. We do not expect to generate revenue from sales of products for several years, if at all. Under the Collaboration Agreement, we received an upfront payment in the amount of $100.0 million in March 2019 and a milestone payment in the amount of $30.0 million in December 2021. Additionally, pursuant to the Collaboration Agreement, we received research and development funding for certain research, manufacturing and clinical development costs. On December 20, 2023, we entered into an Asset Purchase Agreement with Janssen pursuant to which the Company sold and assigned to Janssen a License Agreement between the Company and UCLB relating to the research, development, manufacture and exploitation of the RPGR Product, and other related assets as described in the Asset Purchase Agreement. In connection with entering into the Asset Purchase Agreement, we entered into a Termination Agreement with Janssen terminating the Collaboration Agreement. The Company and Janssen also entered into a Supply Agreement on December 20, 2023 (the “Supply Agreement”) pursuant to which the Company agreed to manufacture and supply the RPGR Product for Janssen. In December 2023, we received a non-refundable upfront payment of $65.0 million in connection with the Asset Purchase Agreement, and in the first quarter of 2024 we received a milestone payment of $50.0 million in connection with the achievement of the initiation of the extension study for the Phase 3 LUMEOS clinical trial for the RPGR Product.

Current wording

We are a clinical stage company and have not generated any product revenues to date. We have ongoing clinical development programs and a broad pipeline of preclinical programs. Since inception, we have incurred significant operating losses. Our net losses for the six-month periods ended June 30, 2024 and 2023 were $69.1 million and $59.9 million, respectively. As of June 30, 2024, we had an accumulated deficit of $623.3 million. We do not expect to generate revenue from sales of products for several years, if at all. Under the Collaboration Agreement, we received an upfront payment in the amount of $100.0 million in March 2019 and a milestone payment in the amount of $30.0 million in December 2021. Additionally, pursuant to the Collaboration Agreement, we received research and development funding for certain research, manufacturing and clinical development costs. On December 20, 2023, we entered into an Asset Purchase Agreement with Johnson & Johnson Innovative Medicine pursuant to which the Company sold and assigned to Johnson & Johnson Innovative Medicine a License Agreement between the Company and UCLB relating to the research, development, manufacture and exploitation of the RPGR Product, and other related assets as described in the Asset Purchase Agreement. In connection with entering into the Asset Purchase Agreement, we entered into a Termination Agreement with Johnson & Johnson Innovative Medicine terminating the Collaboration Agreement. The Company and Johnson & Johnson Innovative Medicine also entered into a Supply Agreement on December 20, 2023 (the “Supply Agreement”) pursuant to which the Company agreed to manufacture and supply the RPGR Product for Johnson & Johnson Innovative Medicine. In December 2023, we received a non-refundable upfront payment of $65.0 million in connection with the Asset Purchase Agreement, and in the first quarter of 2024 we received a milestone payment of $50.0 million in connection with the achievement of the initiation of the extension study for the Phase 3 LUMEOS clinical trial for the RPGR Product.

Previous wording

Our total operating expenses for the three-month periods ended March 31, 2024 and 2023 were $47.5 million and $35.1 million, respectively. We expect to continue incurring increasing costs associated with our clinical activities for AAV-hAQP1 for the treatment of radiation-induced xerostomia and xerostomia associated with Sjogren’s syndrome, as well as for AAV-GAD for the treatment of Parkinson’s disease. We also incurred expenses during the three-month period ended March 31, 2024 and expect to continue to incur expenses related to research activities in additional therapeutic areas to expand our pipeline, developing our potentially transformative gene regulation technology, hiring additional personnel as needed in manufacturing, research, clinical operations, quality and other functional areas, and associated cash and share-based compensation expense, as well as the further development of internal manufacturing capabilities and capacity and other associated costs including the management of our intellectual property portfolio.

Current wording

Our total operating expenses for the three-month periods ended June 30, 2024 and 2023 were $46.2 million and $32.3 million, respectively. For the six-month periods ended June 30, 2024 and 2023, our total operating expenses were $93.7 million and $67.4 million, respectively. We expect to continue incurring increasing costs associated with our clinical activities for AAV-hAQP1 for the treatment of radiation-induced xerostomia and xerostomia associated with Sjogren’s syndrome, as well as for AAV-GAD for the treatment of Parkinson’s disease. We also incurred expenses during the six-month period ended June 30, 2024 and expect to continue to incur expenses related to research activities in additional therapeutic areas to expand our pipeline, developing our potentially transformative gene regulation technology, hiring additional personnel as needed in manufacturing, research, clinical operations, quality and other functional areas, and associated cash and share-based compensation expense, as well as the further development of internal manufacturing capabilities and capacity and other associated costs including the management of our intellectual property portfolio.

Previous wording

Based on our cash, cash equivalents, tax incentive receivable and accounts receivable – related party at March 31, 2024 and the near-term milestone payments we expect to receive under the Asset Purchase Agreement, we estimate that such funds will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2026. This estimate does not include the $285.0 million in milestones we are eligible to receive under the Asset Purchase Agreement upon first commercial sale of an RPGR Product in the United States and in at least one of the United Kingdom, France, Germany, Spain and Italy, for completion of the transfer of certain manufacturing technology to Janssen and upon regulatory approval of a Janssen-selected manufacturing facility in each of the United States and European Union, or EU, for commercial manufacture of the RPGR Product. We have based these estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. See “Liquidity and Capital Resources.” Because of the numerous risks and uncertainties associated with the development of our product candidates, any future product candidates, our platform and technology and because the extent to which we may enter into collaborations with third parties for development of any of our product candidates is unknown, we are unable to estimate

Current wording

Because of the numerous risks and uncertainties associated with the development of our product candidates, any future product candidates, our platform and technology and because the extent to which we may enter into collaborations with third parties for development of any of our product candidates is unknown, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates.

Previous wording

AAV-AIPL1 Specials License in the UK:

Current wording

AAV-AIPL1 Specials License in the U.K.:

Previous wording

The gain on sale of nonfinancial assets represents the value allocated to the nonfinancial assets sold and assigned to Janssen including the UCLB RPGR License Agreement relating to the research, development, manufacture and exploitation of the RPGR Product, and other related assets pursuant to the Asset Purchase Agreement, net of carrying value.

Current wording

The gain on sale of nonfinancial assets represents the value allocated to the nonfinancial assets sold and assigned to Johnson & Johnson Innovative Medicine including the UCLB RPGR License Agreement relating to the research, development, manufacture and exploitation of the RPGR Product, and other related assets pursuant to the Asset Purchase Agreement, net of carrying value.

Previous wording

Expenses of subsidiaries have been translated into U.S. dollars at average exchange rates prevailing during the period. Assets and liabilities have been translated at the rates of exchange on the condensed consolidated balance sheet

Current wording

Expenses of subsidiaries have been translated into U.S. dollars at average exchange rates prevailing during the period. Assets and liabilities have been translated at the rates of exchange on the condensed consolidated balance sheet date. The resulting translation gain and loss adjustments are recorded directly as a separate component of shareholders’ equity and as other comprehensive loss on the condensed consolidated statements of operations and comprehensive loss.

Previous wording

Management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgements that affect the reporting amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgements, including those related to license and collaboration revenue, share-based compensation and accrued expenses. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying value of assets and liabilities that are not readily apparent from our sources. Actual results may differ from these estimates under different assumptions.

Current wording

consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgements, including those related to license and collaboration revenue, share-based compensation and accrued expenses. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying value of assets and liabilities that are not readily apparent from our sources. Actual results may differ from these estimates under different assumptions.

Previous wording

Service revenue was $0.7 million for the three months ended March 31, 2024, due to progress of PPQ services under the Asset Purchase Agreement and related agreements.

Current wording

Service revenue was $0.3 million for the three months ended June 30, 2024, due to progress of PPQ services under the Asset Purchase Agreement and related agreements.

Previous wording

There was no license revenue for the three months ended March 31, 2024, compared to $3.3 million for the three months ended March 31, 2023. The decrease is due to the termination of the Collaboration Agreement concurrent with the execution of the Asset Purchase Agreement.

Current wording

There was no license revenue for the three months ended June 30, 2024, compared to $3.5 million for the three months ended June 30, 2023. The decrease is due to the termination of the Collaboration Agreement concurrent with the execution of the Asset Purchase Agreement.

Previous wording

General and administrative expenses were $13.1 million for the three months ended March 31, 2024, compared to $12.8 million for the three months ended March 31, 2023. The increase of $0.4 million was primarily due to an increase of $0.7 million in share-based compensation, $0.4 million in payroll and payroll-related costs and $0.2 in other office related costs. These increases were partially offset by a decrease of $0.6 million in legal and accounting fees and $0.3 million of insurance costs.

Current wording

General and administrative expenses were $11.3 million for the three months ended June 30, 2024, compared to $12.4 million for the three months ended June 30, 2023. The decrease of $1.1 million was primarily due to a decrease of $1.0 million in share-based compensation, $0.2 million in payroll and payroll-related costs, $0.2 million of insurance costs and $0.2 million in rent and facilities costs. These decreases were partially offset by an increase of $0.4 million in consulting fees and $0.1 million in other office related costs.

Previous wording

three months ended March 31, 2023 was in connection with research funding provided under the Collaboration Agreement which was terminated on December 20, 2023, whereas the reimbursement for the three months ended March 31, 2024 was in connection with transition services we provided to Janssen. These increases were partially offset by decreases of $11.7 million in clinical trial expenses primarily related to bota-vec as a result of a decrease in the number of batches of clinical trial material produced in the three months ended March 31, 2024 compared to the three months ended March 31, 2023 and in addition, as a result of the Asset Purchase Agreement, Janssen is now primarily funding the expenses related to this program. Additionally, expenses related to our preclinical programs decreased by $1.0 million primarily related to preclinical ocular diseases and other research and development costs decreased by $0.2 million.

Current wording

Research and development expenses for the three months ended June 30, 2024 were $34.9 million, compared to $19.9 million for the three months ended June 30, 2023. The increase of $15.0 million was primarily due to a decrease of $20.6 million in reimbursements from Johnson & Johnson Innovative Medicine as the reimbursement for the three months ended June 30, 2023 was in connection with research funding provided under the Collaboration Agreement, which was terminated on December 20, 2023, whereas the reimbursement for the three months ended June 30, 2024 was in connection with transition services we provided to Johnson & Johnson Innovative Medicine. Additionally, expenses related to our preclinical programs increased $1.0 million primarily related to development of our gene regulation technology. These increases were partially offset by decreases of $5.1 million in manufacturing costs primarily due to an increase in the number of batches of clinical trial material produced during the three months ended June 30, 2024 compared to the three months ended June 30, 2023, which costs were charged to the clinical programs, a decrease of $1.4 million in other research and development costs, as well as a decrease of $0.1 million in clinical trial expenses primarily related to bota-vec as

Previous wording

Foreign currency loss was $0.5 million for the three months ended March 31, 2024 compared to a gain of $3.9 million for the three months ended March 31, 2023. The change of $4.4 million was primarily due to the restructuring and payment of certain intercompany receivables and payables. Foreign currency gains and losses subsequent to the restructuring are recorded as a part of accumulated other comprehensive income.

Current wording

Foreign currency loss was $0.3 million for the three months ended June 30, 2024 compared to a gain of $1.9 million for the three months ended June 30, 2023. The change of $2.2 million was primarily due to the restructuring and payment of certain intercompany receivables and payables. Foreign currency gains and losses subsequent to the restructuring are recorded as a part of accumulated other comprehensive income.

Previous wording

Interest income was $1.1 million for the three months ended March 31, 2024 compared to $0.5 million for the three months ended March 31, 2023. The increase of $0.6 million was due to higher interest rates and cash balances during 2024.

Current wording

Interest income was $0.8 million for the three months ended June 30, 2024 compared to $0.7 million for the three months ended June 30, 2023. The increase of $0.1 million was due to higher interest rates and cash balances during 2024.

Previous wording

Interest expense was $3.3 million for the three months ended March 31, 2024 compared to $3.1 million for the three months ended March 31, 2023. The increase of $0.2 million was primarily due to a higher interest rate in connection with the debt financing described in Note 10 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q.

Current wording

Interest expense was $6.5 million for the six months ended June 30, 2024 compared to $6.4 million for the six months ended June 30, 2023. The increase of $0.1 million was primarily due to a higher interest rate in connection with the debt financing described in Note 10 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q

Previous wording

The gain on sale of nonfinancial assets was $29.0 million for the three months ended March 31, 2024 compared to $0 for the three months ended March 31, 2023. This increase was a result of the recognition of the $50.0 million milestone allocated to the nonfinancial assets sold and assigned to Janssen including the UCLB RPGR License Agreement relating to the research, development, manufacture and exploitation of the RPGR Product, and other related assets described in the Asset Purchase Agreement.

Current wording

The gain on sale of nonfinancial assets was $29.0 million for the six months ended June 30, 2024 compared to $0 for the six months ended June 30, 2023. This increase was a result of the recognition of the $50.0 million milestone allocated to the nonfinancial assets sold and assigned to Johnson & Johnson Innovative Medicine including the UCLB RPGR License Agreement relating to the research, development, manufacture and exploitation of the RPGR Product, and other related assets described in the Asset Purchase Agreement.

Previous wording

Since our inception, we have incurred significant operating losses. For the three months ended March 31, 2024, we used $36.7 million in cash flows from operations. We did not generate positive cash flows from operations during the period and there are no assurances that we will generate positive cash flows in the future. Additionally, there are no assurances that we will be successful in obtaining an adequate level of financing for the development and commercialization of our product candidates. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical and clinical development of our product candidates. We expect that our research and development and general and administrative costs will increase in connection with conducting preclinical studies and clinical trials for our product candidates, building out internal capacity to have products manufactured to support preclinical studies and clinical trials as well as to manufacture commercial products, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result of these incurred and expected expenses we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.

Current wording

Since our inception, we have incurred significant operating losses. For the six months ended June 30, 2024, we used $56.2 million in cash flows from operations. We did not generate positive cash flows from operations during the period and there are no assurances that we will generate positive cash flows in the future. Additionally, there are no assurances that we will be successful in obtaining an adequate level of financing for the development and commercialization of our product candidates. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical and clinical development of our product candidates. We expect that our research and development and general and administrative costs will increase in connection with conducting preclinical studies and clinical trials for our product candidates, building out internal capacity to have products manufactured to support preclinical studies and clinical trials as well as to manufacture commercial products, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result of these incurred and expected expenses we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.

Previous wording

We do not currently have any approved products and have never generated any revenue from product sales. We have historically financed our operations primarily through cash on hand and proceeds from the sale of our ordinary shares,

Current wording

We do not currently have any approved products and have never generated any revenue from product sales. We have historically financed our operations primarily through cash on hand and proceeds from the sale of our ordinary shares, series A ordinary shares and convertible preferred C shares and the issuance of debt. In March 2019 and December 2021, we received a $100.0 million upfront payment and a $30.0 million milestone payment, respectively, in connection with

Previous wording

series A ordinary shares and convertible preferred C shares and the issuance of debt. In March 2019 and December 2021, we received a $100.0 million upfront payment and a $30.0 million milestone payment, respectively, in connection with the Collaboration Agreement, which also provided us with research funding. On December 20, 2023, we entered into an Asset Purchase Agreement with Janssen pursuant to which the Company sold and assigned to Janssen the UCLB RPGR License Agreement relating to the research, development, manufacture and exploitation of the RPGR Product, and other related assets as described in the Asset Purchase Agreement. In connection with entering into the Asset Purchase Agreement, we entered into a Termination Agreement with Janssen terminating the Collaboration Agreement. The Company and Janssen also entered into a Supply Agreement on December 20, 2023 pursuant to which we agreed to manufacture and supply the RPGR Product for Janssen. In December 2023, we received a non-refundable upfront payment of $65.0 million in connection with the Asset Purchase Agreement, and in the first quarter of 2024 we received a milestone payment of $50.0 million in connection with the achievement of the initiation of the extension study for the Phase 3 LUMEOS clinical trial for the RPGR Product.

Current wording

the Collaboration Agreement, which also provided us with research funding. On December 20, 2023, we entered into an Asset Purchase Agreement with Johnson & Johnson Innovative Medicine pursuant to which the Company sold and assigned to Johnson & Johnson Innovative Medicine the UCLB RPGR License Agreement relating to the research, development, manufacture and exploitation of the RPGR Product, and other related assets as described in the Asset Purchase Agreement. In connection with entering into the Asset Purchase Agreement, we entered into a Termination Agreement with Johnson & Johnson Innovative Medicine terminating the Collaboration Agreement. The Company and Johnson & Johnson Innovative Medicine also entered into a Supply Agreement on December 20, 2023 pursuant to which we agreed to manufacture and supply the RPGR Product for Johnson & Johnson Innovative Medicine. In December 2023, we received a non-refundable upfront payment of $65.0 million in connection with the Asset Purchase Agreement, and in the first quarter of 2024 we received a milestone payment of $50.0 million in connection with the achievement of the initiation of the extension study for the Phase 3 LUMEOS clinical trial for the RPGR Product.

Previous wording

As of March 31, 2024, we had $120.3 million of cash, cash equivalents and restricted cash.

Current wording

As of June 30, 2024, we had $101.0 million of cash, cash equivalents and restricted cash.

Previous wording

During the three months ended March 31, 2024, our cash used in operating activities of $36.7 million was primarily due to a net loss of $20.4 million as we incurred expenses associated with research activities on our clinical programs, manufacturing of our clinical trial materials, preclinical research programs and general and administrative expenses. The net loss included non-cash income of $18.0 million, which consisted primarily of $29.0 million of a gain on sale of nonfinancial assets, $7.0 million of share-based compensation, $3.3 million of depreciation and amortization, $0.5 million of a foreign currency loss and $0.3 million of amortization of debt discount. Additionally, operating assets, consisting of accounts receivable – related party, prepaid expenses, other assets and other current assets, decreased by $0.2 million and operating liabilities, consisting of accounts payable, accrued expenses, other current liabilities and deferred revenue – related party, increased by $1.5 million.

Current wording

During the six months ended June 30, 2024, our cash used in operating activities of $56.2 million was primarily due to a net loss of $69.1 million as we incurred expenses associated with research activities on our clinical programs, manufacturing of our clinical trial materials, preclinical research programs and general and administrative expenses. The net loss included non-cash income and expense of $8.0 million, which consisted primarily of $29.0 million of a gain on sale of nonfinancial assets, $12.8 million of share-based compensation, $6.5 million of depreciation and amortization, $0.8 million of a foreign currency loss, $0.5 million of amortization of debt discount and a $0.4 million loss on disposal of equipment, furniture and fixtures. Additionally, operating assets, consisting of accounts receivable – related party, prepaid expenses, tax incentive receivable, other assets and other current assets, decreased by $19.5 million and operating liabilities, consisting of accounts payable, accrued expenses and deferred revenue – related party, increased by $1.3 million.

Previous wording

expenses. The net loss included non-cash charges of $5.9 million, which consisted primarily of $6.4 million of share-based compensation, $3.9 million of a foreign currency gain, $3.1 million of depreciation and amortization and $0.3 million of amortization of debt discount. Additionally, operating assets, consisting of accounts receivable – related party, prepaid expenses, and other current assets, increased by $12.8 million and operating liabilities, consisting of accounts payable and accrued expenses, decreased by $0.2 million.

Current wording

During the six months ended June 30, 2023, our cash used in operating activities of $66.4 million was primarily due to a net loss of $59.9 million as we incurred expenses associated with research activities on our clinical programs, manufacturing of our clinical trial materials, preclinical research programs and general and administrative expenses. The net loss included non-cash charges of $14.7 million, which consisted primarily of $13.7 million of share-based compensation, $5.8 million of a foreign currency gain, $6.3 million of depreciation and amortization and $0.5 million of amortization of debt discount. Additionally, operating assets, consisting of accounts receivable – related party, prepaid expenses, and other current assets, increased by $10.2 million and operating liabilities, consisting of accounts payable, accrued expenses and deferred revenue – related party, decreased by $11.0 million.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2024 of $27.3 million consisted of $29.0 million from proceeds from the sale of nonfinancial assets offset by $1.7 million of purchases of property and equipment for our manufacturing, laboratory and process development facilities.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2024 of $26.0 million consisted of $29.0 million from proceeds from the sale of nonfinancial assets offset by $3.0 million of purchases of property and equipment for our manufacturing, laboratory and process development facilities.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2023 of $8.6 million consisted of purchases of property and equipment for our manufacturing, laboratory and process development facilities and buildout costs of our new facilities.

Current wording

Net cash used in investing activities for the six months ended June 30, 2023 of $13.6 million consisted of purchases of property and equipment for our manufacturing, laboratory and process development facilities and buildout costs of our new facilities.

Previous wording

Net cash used in financing activities was $1.3 million for the three months ended March 31, 2024, which consisted of the payment of $2.2 million to cover tax withholding obligations upon the vesting of restricted share unit awards offset by $1.0 million of proceeds from an “at-the-market” offering of our ordinary shares, net of one-time costs relating to the preparation and filing of the shelf registration statement, accounting and legal fees, and negotiation of the sales agreement.

Current wording

Net cash provided by financing activities was $0.3 million for the six months ended June 30, 2024, which consisted of $2.5 million of proceeds from an “at-the-market” offering of our ordinary shares, net of one-time costs relating to the preparation and filing of the shelf registration statement, accounting and legal fees, and negotiation of the sales agreement offset by the payment of $2.2 million to cover tax withholding obligations upon the vesting of restricted share unit awards.

Previous wording

Net cash used in financing activities was $1.2 million for the three months ended March 31, 2023, which consisted of the payment of $1.2 million to cover tax withholding obligations upon the vesting of restricted share unit awards.

Current wording

Net cash provided by financing activities was $56.7 million for the six months ended June 30, 2023, which consisted of $57.9 million net proceeds raised from the private placement share issuance in May 2023 and the payment of $1.2 million to cover tax withholding obligations upon the vesting of restricted share unit awards.