Organization and Basis of Presentation	6 Months Ended
Jun. 30, 2026
Organization and Basis of Presentation
Organization and Basis of Presentation	1. Organization and Basis of Presentation The Company MeiraGTx Holdings plc and subsidiaries (the “Company” or “MeiraGTx Holdings”), an exempted company incorporated under the laws of the Cayman Islands, is a vertically integrated, clinical-stage genetic medicines company with a broad pipeline of four late-stage clinical programs. Each of these programs uses local delivery of small doses, resulting in disease-modifying effects in both inherited and more common diseases, in the eye, radiation-induced xerostomia and Parkinson’s disease. The Company uses its innovative technology in optimization of capsids, promoters, and novel translational control elements to develop best-in-class, potent, safe viral vectors. The Company’s broad pipeline is supported by end-to-end in-house manufacturing. The Company has built the most comprehensive manufacturing capabilities in the industry, including two that are licensed for good manufacturing practices (“GMP”) viral vector production and a GMP Quality Control facility with clinical and commercial licensure. In addition, the Company has developed a proprietary manufacturing platform process over 9 years based on more than 20 different viral vectors with leading yield and quality aspects and commercial readiness. Uniquely, the Company has developed a novel technology for in vivo delivery of any biologic therapeutic using oral small molecules. This transformative riboswitch gene regulation platform technology allows precise, dose-responsive expression of gene expression by oral small molecules. The Company is focusing the riboswitch platform on regulated in vivo delivery of metabolic peptides, including leptin, GLP-1, GIP, glucagon, amylin and PYY, as well as cell therapy, CAR-T for liquid and solid tumors and autoimmune diseases, and additionally, PNS targets addressing long-term intractable pain. The Company has developed the technology to apply genetic medicine to common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains high. Asset Purchase and Related Agreements with Janssen Pharmaceuticals, Inc. On April 15, 2026 (“Janssen Closing Date”), the Company and MeiraGTx Ocular entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Janssen Pharmaceuticals, Inc. (“Janssen”) to reacquire the global rights to botaretigene sparoparvovec (“bota-vec”) for the treatment of X-linked retinitis pigmentosa associated with mutations in the RPGR gene (the “RPGR Product”) through the acquisition of the license agreement and related assets associated with the development, manufacture and commercialization of the RPGR Product. The Company paid Janssen an upfront cash purchase price of $25.0 million, regaining full ownership and control of the RPGR Product and all associated future development and commercialization rights. In addition to the upfront payment, the Asset Purchase Agreement includes a one-time contingent milestone payment of $50.0 million, payable upon the achievement of both of the following regulatory and commercial milestones: U.S. regulatory approval of the RPGR Product and cumulative U.S. net sales exceeding $250.0 million. The Company is also obligated to pay Janssen tiered royalties in the mid-teens on future global net sales of RPGR Products beginning on or after July 1, 2029. If the Company enters into future licensing or commercialization arrangements for the RPGR Product with third parties, Janssen is also entitled to receive a portion of certain upfront and milestone payments, as well as royalties based on amounts received from such third parties or, in certain cases, on the third party's net sales of RPGR Products. As part of the transaction, the parties entered into a Termination Agreement on the Janssen Closing Date (the “Termination Agreement”) to terminate the prior asset purchase agreement (the “Original Asset Purchase Agreement”) pursuant to which the Company and MeiraGTx UK II sold the RPGR Product to Janssen, and the related supply agreement (the “Supply Agreement”), each entered into on December 20, 2023, thereby restoring the Company’s full strategic and operational control over the RPGR Product while establishing the future contingent payment obligations described above. Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”), the investment arm of Johnson & Johnson and the indirect owner of Janssen, continues to hold more than 5% of the Company's outstanding ordinary shares. As a result, Janssen remains a related party of the Company for financial reporting purposes. In connection with the above transaction, JJDC and Janssen have also agreed not to sell or transfer any of the Company’s ordinary shares or securities convertible into, exchangeable for, or exercisable for the Company’s ordinary shares, for twelve months following the Janssen Closing Date and following such twelve month period, if they ever intend to sell the Company’s shares after the twelve month period, they will provide written notice to the Company at least five business days prior to taking any action. Eli Lilly and Company Collaboration Agreement On November 7, 2025 (the “Lilly Effective Date”), MeiraGTx Ocular, MeiraGTx Limited and MeiraGTx UK II (collectively, “MeiraGTx”), entered into a strategic collaboration and license agreement with Eli Lilly and Company (“Lilly”) (the “Lilly Collaboration Agreement”) for the research, development and commercialization of genetic medicines in and related to the area of ophthalmology. Under the Lilly Collaboration Agreement, MeiraGTx has granted Lilly exclusive, worldwide rights to research, develop and commercialize the Company’s product candidate AAV-AIPL1, which treats Leber congenital amaurosis 4, or LCA4, caused by mutations in the AIPL1 gene, as well as two other preclinical product candidates which are intended to treat other inherited retinal dystrophies. As of the Lilly Effective Date, Lilly has (i) an exclusive license to proprietary intravitreal capsids for use with up to five targets, relating to or useful in the field of ophthalmology, to be selected by Lilly, (ii) an exclusive license to proprietary pan-retinal or rod-specific promoters for use with up to five targets, relating to or useful in the field of ophthalmology, to be selected by Lilly and (iii) a right of first designation with respect to certain target-specific transactions that MeiraGTx Ocular or its affiliates may seek to pursue in the field of ophthalmology. Lilly also has a right of first negotiation for use of the Company’s proprietary riboswitch technology in the field of ophthalmological gene editing. Under the terms of the Lilly Collaboration Agreement, MeiraGTx received an upfront payment of $75.0 million after signing the Lilly Collaboration Agreement and will be eligible to receive up to over $400.0 million in total milestone payments, including up to $135.0 million in other potential near-term cash consideration upon the achievement of certain development and regulatory approval milestones. Lilly has the right to research, develop and commercialize products under the Lilly Collaboration Agreement, at its own cost. The Company may also perform research, development and manufacturing services for Lilly under the Lilly Collaboration Agreement and related agreements, for which it is entitled to reimbursement in accordance with the applicable contractual terms. The Lilly Collaboration Agreement also provides for tiered royalties to be paid to MeiraGTx Ocular on future product sales. Hologen Strategic Collaboration On March 9, 2025, the Company and certain of its affiliates entered into a strategic collaboration with Hologen Limited (“Hologen”) and certain of its affiliates to advance the development of certain central nervous system gene therapy programs and to support the Company’s manufacturing capabilities. Hologen is a leading developer of multi-modal generative AI foundation models of real-world clinical data for clinical medicine and pharmaceutical drug development. Under the collaboration, Hologen committed to provide an upfront payment of $200.0 million and up to an additional $230.0 million to fund the development of the Company’s AAV-GAD program for the treatment of Parkinson’s disease to commercialization and other locally delivered central nervous system therapies. The Company also received an aggregate of 500,000 Class A shares of Hologen for nominal consideration. As of June 30, 2026, Hologen had funded $105.0 million of the upfront payment commitment. The collaboration is governed by two framework agreements. The first, between the Company, MeiraGTx Neuro UK, Reogen Limited (formerly known as Hologen Neuro AI Limited) (“Reogen”) and Hologen, relates to the management of the business and affairs of Reogen, including the research, development, manufacture and commercialization of our (i) AAV-GAD investigational gene therapy for the treatment of Parkinson’s disease, AAV-BDNF investigational gene therapy for the treatment of genetic obesity disorders and other potential locally delivered genetic medicines to the central nervous system (the “Clinical Programs”) and (ii) proprietary device designed to effect the local delivery of a gene therapy product into the central nervous system or any topographic or subcutaneous tissue modification on the face and scalp, of humans or animals (the “Delivery Device”), in each case, in accordance with the terms and conditions of the Hologen Collaboration Agreement as further described below. The second, between MeiraGTx Manufacturing, MeiraGTx Limited and Hologen, provides for the management of the business and affairs of MeiraGTx Manufacturing, including Hologen’s investment in MeiraGTx Manufacturing and its participation in funding the manufacturing business. During the second quarter of 2026, the parties completed the initial closing of the strategic collaboration and entered into amendments to the framework agreements to facilitate the initial funding and investment structures. As part of the initial closing, the Company, MeiraGTx Neuro UK, MeiraGTx Neuro I, Reogen, Hologen Neuro AI UK Limited and Hologen entered into the Collaboration and License Agreement, dated as of April 20, 2026 (the “Hologen Collaboration Agreement”) governing the research, development, manufacturing and commercialization of the Clinical Programs and the Delivery Device. The parties also completed Hologen’s initial investment in MeiraGTx Manufacturing. Following the initial closing, MeiraGTx Neuro UK holds a 39% ownership interest in Reogen, and Hologen holds a minority interest in MeiraGTx Manufacturing. Following the initial closing, Hologen will fund an additional $95.0 million to satisfy the remaining portion of the upfront payments provided for under the framework agreements and the Hologen Collaboration Agreement. These funds will be used by Hologen to purchase (i) a portion of the Reogen shares held by MeiraGTx Neuro UK, such that following the purchase, MeiraGTx Neuro UK and Hologen are expected to hold 30% and 70% of the outstanding shares in Reogen, respectively, and (ii) additional shares in MeiraGTx Manufacturing from MeiraGTx Limited, such that following the purchase, Hologen will have increased its minority interest in MeiraGTx Manufacturing. The Company's obligation to issue additional MeiraGTx Manufacturing shares in exchange for the additional funding gives rise to a contingent forward financial instrument, which is recognized and measured at fair value as described in Note 5. The framework agreement relating to MeiraGTx Manufacturing also provides Hologen with an option to increase its ownership interest in MeiraGTx Manufacturing to up to 40%, which may be exercised within twelve months after Hologen purchases all of its additional shares in MeiraGTx Manufacturing using a portion of the proceeds from the remaining amount of the upfront payment to be paid, subject to the terms and conditions of the framework agreement. This option gives rise to a financial instrument that is recognized and measured at fair value as described in Note 5. If Hologen does not exercise the option during that twelve month period, then the Company has an option to purchase all of the shares of MeiraGTx Manufacturing held by Hologen for the same price that Hologen paid for such shares. The Company may exercise its option beginning on the third anniversary of the date Hologen purchases its additional shares in MeiraGTx Manufacturing and ending three years thereafter. Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain reclassifications of prior period activities have been made to conform to current year presentation. Interim Financial Statements The accompanying condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete consolidated financial statements. In the opinion of management, the condensed consolidated financial statements include all adjustments (consisting of normal recurring adjustments) necessary in order to make the condensed consolidated financial statements not misleading. Operating results for the six-month period ended June 30, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “Form 10-K”). Liquidity The Company does not currently have any approved products and has never generated any revenue from product sales. Although the Company has achieved profitable operations during the current period, such profitability was primarily attributable to non-recurring transactions and there is no assurance that profitable operations could be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing, and commercialization of the Company’s product candidates will require significant additional financing. The Company’s accumulated deficit at June 30, 2026 totaled $701.8 million, and management expects to incur substantial losses in future periods. The success of the Company is subject to certain risks and uncertainties, including, among others: uncertainty of product development; competition in the Company’s field of use; uncertainty of capital availability; uncertainty in the Company’s ability to enter into agreements and consummate transactions with collaborative partners; expanding and protecting the Company’s intellectual property portfolio; dependence on third parties; and dependence on key personnel. For the six months ended June 30, 2026, the Company had $20.7 million cash flows used in operations. There are no assurances that the Company will generate positive cash flows in the future. Additionally, there are no assurances that the Company will be successful in obtaining an adequate level of financing for the development and commercialization of its product candidates. As of June 30, 2026, the Company had cash, cash equivalents and restricted cash in the amount of $145.4 million, which consisted of depository and money market accounts held at large international banks. The Company estimates that its cash and cash equivalents on-hand, accounts receivable, accounts receivable – related party, unbilled receivables – related party and tax incentive receivable at June 30, 2026, together with the $35.0 million gross proceeds from the Second Purchase of the Royalty Notes under the Royalty Note Purchase Agreement and sale of ordinary shares to the Purchasers under the Securities Purchase Agreement (as such capitalized terms are defined in, and such transactions are described in, Note 12) in the third quarter of 2026 will be sufficient to cover its expenses for at least the next twelve months from the date of issuance of these condensed consolidated financial statements. This estimate does not include the additional $95.0 million upfront payment from Hologen or the $135.0 million in potential near-term cash consideration from Lilly upon achievement of certain development and regulatory approval milestones, or any subsequent tranches available under the Royalty Note Purchase Agreement. Risks and Uncertainties The Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory and other risks, including the potential risk of business failure. The Company’s capital resources and operations to date have been funded primarily with the proceeds from the Company’s collaboration and business development activities and private and public equity offerings, as well as proceeds from debt financings. In the future, the Company may seek to raise additional capital through equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources to enable it to complete the development and potential commercialization of its product candidates.

Organization and Basis of Presentation

6 Months Ended

Jun. 30, 2026

Organization and Basis of Presentation

1. Organization and Basis of Presentation

The Company

MeiraGTx Holdings plc and subsidiaries (the “Company” or “MeiraGTx Holdings”), an exempted company incorporated under the laws of the Cayman Islands, is a vertically integrated, clinical-stage genetic medicines company with a broad pipeline of four late-stage clinical programs. Each of these programs uses local delivery of small doses, resulting in disease-modifying effects in both inherited and more common diseases, in the eye, radiation-induced xerostomia and Parkinson’s disease. The Company uses its innovative technology in optimization of capsids, promoters, and novel translational control elements to develop best-in-class, potent, safe viral vectors. The Company’s broad pipeline is supported by end-to-end in-house manufacturing. The Company has built the most comprehensive manufacturing capabilities in the industry, including two that are licensed for good manufacturing practices (“GMP”) viral vector production and a GMP Quality Control facility with clinical and commercial licensure. In addition, the Company has developed a proprietary manufacturing platform process over 9 years based on more than 20 different viral vectors with leading yield and quality aspects and commercial readiness. Uniquely, the Company has developed a novel technology for in vivo delivery of any biologic therapeutic using oral small molecules. This transformative riboswitch gene regulation platform technology allows precise, dose-responsive expression of gene expression by oral small molecules. The Company is focusing the riboswitch platform on regulated in vivo delivery of metabolic peptides, including leptin, GLP-1, GIP, glucagon, amylin and PYY, as well as cell therapy, CAR-T for liquid and solid tumors and autoimmune diseases, and additionally, PNS targets addressing long-term intractable pain. The Company has developed the technology to apply genetic medicine to common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains high.

Asset Purchase and Related Agreements with Janssen Pharmaceuticals, Inc.

On April 15, 2026 (“Janssen Closing Date”), the Company and MeiraGTx Ocular entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Janssen Pharmaceuticals, Inc. (“Janssen”) to reacquire the global rights to botaretigene sparoparvovec (“bota-vec”) for the treatment of X-linked retinitis pigmentosa associated with mutations in the RPGR gene (the “RPGR Product”) through the acquisition of the license agreement and related assets associated with the development, manufacture and commercialization of the RPGR Product. The Company paid Janssen an upfront cash purchase price of $25.0 million, regaining full ownership and control of the RPGR Product and all associated future development and commercialization rights.

In addition to the upfront payment, the Asset Purchase Agreement includes a one-time contingent milestone payment of $50.0 million, payable upon the achievement of both of the following regulatory and commercial milestones: U.S. regulatory approval of the RPGR Product and cumulative U.S. net sales exceeding $250.0 million. The Company is also obligated to pay Janssen tiered royalties in the mid-teens on future global net sales of RPGR Products beginning on or after July 1, 2029. If the Company enters into future licensing or commercialization arrangements for the RPGR Product with third parties, Janssen is also entitled to receive a portion of certain upfront and milestone payments, as well as royalties based on amounts received from such third parties or, in certain cases, on the third party's net sales of RPGR Products.

As part of the transaction, the parties entered into a Termination Agreement on the Janssen Closing Date (the “Termination Agreement”) to terminate the prior asset purchase agreement (the “Original Asset Purchase Agreement”) pursuant to which the Company and MeiraGTx UK II sold the RPGR Product to Janssen, and the related supply agreement (the “Supply Agreement”), each entered into on December 20, 2023, thereby restoring the Company’s full strategic and operational control over the RPGR Product while establishing the future contingent payment obligations described above.

Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”), the investment arm of Johnson & Johnson and the indirect owner of Janssen, continues to hold more than 5% of the Company's outstanding ordinary shares. As a result, Janssen remains a related party of the Company for financial reporting purposes. In connection with the above transaction, JJDC and Janssen have also agreed not to sell or transfer any of the Company’s ordinary shares or securities convertible into, exchangeable for, or exercisable for the Company’s ordinary shares, for twelve months following the Janssen Closing Date and following such twelve month period, if they ever intend to sell the Company’s shares after the twelve month period, they will provide written notice to the Company at least five business days prior to taking any action.

Eli Lilly and Company Collaboration Agreement

On November 7, 2025 (the “Lilly Effective Date”), MeiraGTx Ocular, MeiraGTx Limited and MeiraGTx UK II (collectively, “MeiraGTx”), entered into a strategic collaboration and license agreement with Eli Lilly and Company (“Lilly”) (the “Lilly Collaboration Agreement”) for the research, development and commercialization of genetic medicines in and related to the area of ophthalmology. Under the Lilly Collaboration Agreement, MeiraGTx has granted Lilly exclusive, worldwide rights to research, develop and commercialize the Company’s product candidate AAV-AIPL1, which treats Leber congenital amaurosis 4, or LCA4, caused by mutations in the AIPL1 gene, as well as two other preclinical product candidates which are intended to treat other inherited retinal dystrophies. As of the Lilly Effective Date, Lilly has (i) an exclusive license to proprietary intravitreal capsids for use with up to five targets, relating to or useful in the field of ophthalmology, to be selected by Lilly, (ii) an exclusive license to proprietary pan-retinal or rod-specific promoters for use with up to five targets, relating to or useful in the field of ophthalmology, to be selected by Lilly and (iii) a right of first designation with respect to certain target-specific transactions that MeiraGTx Ocular or its affiliates may seek to pursue in the field of ophthalmology. Lilly also has a right of first negotiation for use of the Company’s proprietary riboswitch technology in the field of ophthalmological gene editing.

Under the terms of the Lilly Collaboration Agreement, MeiraGTx received an upfront payment of $75.0 million after signing the Lilly Collaboration Agreement and will be eligible to receive up to over $400.0 million in total milestone payments, including up to $135.0 million in other potential near-term cash consideration upon the achievement of certain development and regulatory approval milestones. Lilly has the right to research, develop and commercialize products under the Lilly Collaboration Agreement, at its own cost. The Company may also perform research, development and manufacturing services for Lilly under the Lilly Collaboration Agreement and related agreements, for which it is entitled to reimbursement in accordance with the applicable contractual terms. The Lilly Collaboration Agreement also provides for tiered royalties to be paid to MeiraGTx Ocular on future product sales.

Hologen Strategic Collaboration

On March 9, 2025, the Company and certain of its affiliates entered into a strategic collaboration with Hologen Limited (“Hologen”) and certain of its affiliates to advance the development of certain central nervous system gene therapy programs and to support the Company’s manufacturing capabilities. Hologen is a leading developer of multi-modal generative AI foundation models of real-world clinical data for clinical medicine and pharmaceutical drug development. Under the collaboration, Hologen committed to provide an upfront payment of $200.0 million and up to an additional $230.0 million to fund the development of the Company’s AAV-GAD program for the treatment of Parkinson’s disease to commercialization and other locally delivered central nervous system therapies. The Company also received an aggregate of 500,000 Class A shares of Hologen for nominal consideration. As of June 30, 2026, Hologen had funded $105.0 million of the upfront payment commitment.

The collaboration is governed by two framework agreements. The first, between the Company, MeiraGTx Neuro UK, Reogen Limited (formerly known as Hologen Neuro AI Limited) (“Reogen”) and Hologen, relates to the management of the business and affairs of Reogen, including the research, development, manufacture and commercialization of our (i) AAV-GAD investigational gene therapy for the treatment of Parkinson’s disease, AAV-BDNF investigational gene therapy for the treatment of genetic obesity disorders and other potential locally delivered genetic medicines to the central nervous system (the “Clinical Programs”) and (ii) proprietary device designed to effect the local delivery of a gene therapy product into the central nervous system or any topographic or

subcutaneous tissue modification on the face and scalp, of humans or animals (the “Delivery Device”), in each case, in accordance with the terms and conditions of the Hologen Collaboration Agreement as further described below. The second, between MeiraGTx Manufacturing, MeiraGTx Limited and Hologen, provides for the management of the business and affairs of MeiraGTx Manufacturing, including Hologen’s investment in MeiraGTx Manufacturing and its participation in funding the manufacturing business.

During the second quarter of 2026, the parties completed the initial closing of the strategic collaboration and entered into amendments to the framework agreements to facilitate the initial funding and investment structures. As part of the initial closing, the Company, MeiraGTx Neuro UK, MeiraGTx Neuro I, Reogen, Hologen Neuro AI UK Limited and Hologen entered into the Collaboration and License Agreement, dated as of April 20, 2026 (the “Hologen Collaboration Agreement”) governing the research, development, manufacturing and commercialization of the Clinical Programs and the Delivery Device. The parties also completed Hologen’s initial investment in MeiraGTx Manufacturing. Following the initial closing, MeiraGTx Neuro UK holds a 39% ownership interest in Reogen, and Hologen holds a minority interest in MeiraGTx Manufacturing.

Following the initial closing, Hologen will fund an additional $95.0 million to satisfy the remaining portion of the upfront payments provided for under the framework agreements and the Hologen Collaboration Agreement. These funds will be used by Hologen to purchase (i) a portion of the Reogen shares held by MeiraGTx Neuro UK, such that following the purchase, MeiraGTx Neuro UK and Hologen are expected to hold 30% and 70% of the outstanding shares in Reogen, respectively, and (ii) additional shares in MeiraGTx Manufacturing from MeiraGTx Limited, such that following the purchase, Hologen will have increased its minority interest in MeiraGTx Manufacturing. The Company's obligation to issue additional MeiraGTx Manufacturing shares in exchange for the additional funding gives rise to a contingent forward financial instrument, which is recognized and measured at fair value as described in Note 5. The framework agreement relating to MeiraGTx Manufacturing also provides Hologen with an option to increase its ownership interest in MeiraGTx Manufacturing to up to 40%, which may be exercised within twelve months after Hologen purchases all of its additional shares in MeiraGTx Manufacturing using a portion of the proceeds from the remaining amount of the upfront payment to be paid, subject to the terms and conditions of the framework agreement. This option gives rise to a financial instrument that is recognized and measured at fair value as described in Note 5. If Hologen does not exercise the option during that twelve month period, then the Company has an option to purchase all of the shares of MeiraGTx Manufacturing held by Hologen for the same price that Hologen paid for such shares. The Company may exercise its option beginning on the third anniversary of the date Hologen purchases its additional shares in MeiraGTx Manufacturing and ending three years thereafter.

Basis of Presentation

The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain reclassifications of prior period activities have been made to conform to current year presentation.

Interim Financial Statements

The accompanying condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete consolidated financial statements. In the opinion of management, the condensed consolidated financial statements include all adjustments (consisting of normal recurring adjustments) necessary in order to make the condensed consolidated financial statements not misleading. Operating results for the six-month period ended June 30, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “Form 10-K”).

Liquidity

The Company does not currently have any approved products and has never generated any revenue from product sales. Although the Company has achieved profitable operations during the current period, such profitability was primarily attributable to non-recurring transactions and there is no assurance that profitable operations could be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing, and commercialization of the Company’s product candidates will require significant additional financing. The Company’s accumulated deficit at June 30, 2026 totaled $701.8 million, and management expects to incur substantial losses in future periods. The success of the Company is subject to certain risks and uncertainties, including, among others: uncertainty of product development; competition in the Company’s field of use; uncertainty of capital availability; uncertainty in the Company’s ability to enter into agreements and consummate transactions with collaborative partners; expanding and protecting the Company’s intellectual property portfolio; dependence on third parties; and dependence on key personnel. For the six months ended June 30, 2026, the Company had $20.7 million cash flows used in operations. There are no assurances that the Company will generate positive cash flows in the future. Additionally, there are no assurances that the Company will be successful in obtaining an adequate level of financing for the development and commercialization of its product candidates.

As of June 30, 2026, the Company had cash, cash equivalents and restricted cash in the amount of $145.4 million, which consisted of depository and money market accounts held at large international banks. The Company estimates that its cash and cash equivalents on-hand, accounts receivable, accounts receivable – related party, unbilled receivables – related party and tax incentive receivable at June 30, 2026, together with the $35.0 million gross proceeds from the Second Purchase of the Royalty Notes under the Royalty Note Purchase Agreement and sale of ordinary shares to the Purchasers under the Securities Purchase Agreement (as such capitalized terms are defined in, and such transactions are described in, Note 12) in the third quarter of 2026 will be sufficient to cover its expenses for at least the next twelve months from the date of issuance of these condensed consolidated financial statements. This estimate does not include the additional $95.0 million upfront payment from Hologen or the $135.0 million in potential near-term cash consideration from Lilly upon achievement of certain development and regulatory approval milestones, or any subsequent tranches available under the Royalty Note Purchase Agreement.

Risks and Uncertainties

The Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory and other risks, including the potential risk of business failure.

The Company’s capital resources and operations to date have been funded primarily with the proceeds from the Company’s collaboration and business development activities and private and public equity offerings, as well as proceeds from debt financings. In the future, the Company may seek to raise additional capital through equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources to enable it to complete the development and potential commercialization of its product candidates.