Damora Therapeutics, Inc.

Previous wording

These candidates leverage multiple distinct antibody mechanisms to target mutCALR, and together have the potential to address the full spectrum of patients with mutCALR-driven MPNs, regardless of mutation type, disease subtype or disease severity. Combined with proprietary antibody design features enabling high potency across CALR mutation types, we believe each asset profile has best-in-class potential. Our portfolio of mutCALR targeted therapies includes:

Current wording

Our product candidates leverage multiple distinct antibody mechanisms to target mutCALR, and together have the potential to address the full spectrum of patients with mutCALR-driven MPNs, regardless of mutation type, disease subtype or disease severity. Combined with proprietary antibody design features enabling high potency across CALR mutation types, we believe each asset profile has best-in-class potential. Our portfolio of mutCALR targeted therapies includes:

Previous wording

Both DMR-001 and DMR-002 were designed to have an extended half-life supporting convenient once-monthly subcutaneous administration.

Current wording

Both DMR-001 and DMR-002 are designed to have pan-mutant activity against Type 1 and non-Type 1 mutCALR, including Type 2 mutCALR, and an extended half-life supporting convenient once-monthly subcutaneous administration.

Previous wording

Beginning with our lead asset DMR-001, we are developing these candidates for the treatment of essential thrombocythemia (“ET”), an MPN associated with the overproduction of platelets, and myelofibrosis (“MF”), an MPN involving the overproliferation of blood cells and deposition of fibrous material in the bone marrow and spleen. Approximately 25% and 35% of cases of ET and MF, respectively, are caused by mutCALR rather than mutations in Janus-associated kinase 2 (“JAK2”). In contrast to marketed therapies for ET and MF, DMR-001 is designed to selectively target cells that express mutCALR while avoiding the adverse effects associated with non-specific cytoreductive drugs. Furthermore, DMR-001 was designed to have increased affinity, potency and a prolonged half-life when compared with other antibodies in development that target mutCALR. We believe that DMR-001’s potential to combine increased clinical activity against all mutCALR subtypes and improved pharmacokinetics enabling optimized subcutaneous administration position it as a potential best-in-class therapy for patients with ET and MF.

Current wording

Beginning with our lead asset DMR-001, we are developing these candidates for the treatment of essential thrombocythemia (“ET”), an MPN associated with the overproduction of platelets, and myelofibrosis (“MF”), an MPN involving the overproliferation of blood cells and deposition of fibrous material in the bone marrow and spleen. Approximately 25% and 35% of cases of ET and MF, respectively, are caused by mutCALR rather than Janus kinase 2 (“JAK2”) or other mutations. In contrast to marketed therapies for ET and MF, DMR-001 is designed to selectively target cells that express mutCALR while avoiding the adverse effects associated with non-specific cytoreductive drugs. Furthermore, DMR-001 was designed to have increased affinity, potency and a prolonged half-life when compared with other antibodies in development that target mutCALR. We believe that DMR-001’s potential to combine increased clinical activity against all mutCALR subtypes and improved pharmacokinetics enabling optimized subcutaneous administration positions it as a potential best-in-class therapy for patients with ET and MF.

Previous wording

MPNs are caused by excessive proliferation of myeloid cells. In some patients, including ET patients, MPNs are considered chronic diseases that lead to significant decreases in quality of life. MPNs also include MF, which is associated with poor prognosis and increased mortality. One feature that makes MPNs attractive indications for drug development is that mutations in just a small number of genes are responsible for a significant percentage of cases, which enables the opportunity to develop targeted therapies. Our goal is to develop a portfolio of targeted mutation-directed candidates to address the full spectrum of patients with mutCALR-driven MPNs.

Current wording

ET and MF are chronic diseases that lead to significant decreases in quality of life. In addition, MF is associated with poor prognosis and increased mortality. One feature that makes MPNs attractive indications for drug development is that mutations in just a small number of genes are responsible for a significant percentage of cases, which enables the opportunity to develop targeted therapies. Our goal is to develop a portfolio of targeted mutation-directed candidates to address the full spectrum of patients with mutCALR-driven MPNs.

Previous wording

We recently initiated our Phase 1/1b trial of DMR-001 in ET and MF patients, and in parallel to advancing DMR-001, we plan to make our first regulatory submission for DMR-002 in the second half of 2026 and for DMR-003 in 2027.

Current wording

United States. In parallel to advancing DMR-001, we plan to make our first regulatory submission for DMR-002 in the fourth quarter of 2026 and for DMR-003 in 2027.

Previous wording

We believe that DMR-001 has the potential to become a best-in-class anti-mutCALR therapy due to two differentiating features compared to marketed therapies and therapies in development, including INCA033989, an anti-mutCALR antibody in clinical development by a third party. First, DMR-001 is a potent, selective mutCALR-targeted antibody with potent activity across both Type 1 and non-Type 1 CALR mutations, including Type 2 mutations. Second, DMR-001 was engineered to have an increased half-life in circulation through the incorporation of sequence modifications that have been shown to improve pharmacokinetics and meaningfully extend the half-life of drugs in humans. We believe the combination of these features should enable DMR-001 to show improved clinical activity with a less frequent and more convenient subcutaneous delivery compared to other approaches.

Current wording

We believe that DMR-001 has the potential to become a best-in-class anti-mutCALR therapy due to multiple differentiating features compared to marketed therapies and therapies in development, including INCA033989, an anti-mutCALR antibody in clinical development by a third party. First, DMR-001 is a selective mutCALR-targeted antibody with potent activity across both Type 1 and non-Type 1 CALR mutations, including Type 2 mutations. Second, DMR-001 was engineered to have an increased half-life in circulation through the incorporation of sequence modifications that have been shown to improve pharmacokinetics and meaningfully extend the half-life of drugs in humans. We believe the combination of these features should enable DMR-001 to show improved clinical activity with a less frequent and more convenient subcutaneous delivery compared to other approaches.

Previous wording

At the European Hematology Association (“EHA”) 2026 Congress, we presented preclinical data for DMR-001 highlighting its best-in-class potential. Compared to a reference mutCALR monoclonal antibody that we generated internally for research purposes, DMR-001 showed higher affinity and slower off-rate in Type 1 and Type 2 kinetic binding models, stronger on-cell binding and inhibition of proliferation in Type 1 and Type 2 cellular assays, and longer half-life in non-human primates. Notably,

Current wording

At the European Hematology Association (“EHA”) Congress in June 2026, we presented preclinical data for DMR-001 highlighting its best-in-class potential. Compared to a reference mutCALR monoclonal antibody that we generated internally for research purposes, DMR-001 showed higher affinity and slower off-rate in Type 1 and Type 2 kinetic binding models, stronger on-cell binding and inhibition of proliferation in Type 1 and Type 2 cellular assays, and longer half-life in non-human primates. Notably, DMR-001 showed 26-fold greater inhibition of cell proliferation in Type 2 mutCALR and 5-fold longer half-life versus the reference mutCALR antibody. These comparisons are based on preclinical studies conducted by us and not on head-to-head clinical trials, and results observed in preclinical models may not be predictive of results in humans.

Previous wording

We recently initiated our Phase 1/1b trial of DMR-001 in ET and MF patients, with receipt of health authority approval in the first country. We plan to complete additional regulatory submissions for DMR-001 in the second half of 2026 to expand the Phase 1/1b trial globally and enable two proof-of-concept readouts beginning mid-2027. The Phase 1/1b trial is designed to rapidly identify a recommended dose for the expansion cohorts leveraging an adaptive Bayesian design enabling patient enrichment, dose escalation in a combined ET and MF population, and a starting dose of 100 mg administered subcutaneously once monthly, which is expected to be in the range of anticipated therapeutic exposure based on preclinical data showing high potency and extended half-life. We plan to initiate expansion cohorts next year in multiple ET and MF patient populations. Subject to the results of this Phase 1/1b trial, we plan to initiate Phase 3 development of DMR-001 as early as mid-2028.

Current wording

The CLARITY-101 trial is designed to rapidly identify a recommended dose for the expansion cohorts leveraging an adaptive Bayesian design enabling patient enrichment, dose escalation in a combined ET and MF population, and a starting dose of 100 mg administered subcutaneously once monthly, which is expected to be in the range of anticipated therapeutic exposure based on preclinical data showing high potency and extended half-life. We plan to initiate expansion cohorts in 2027 in multiple ET and

Previous wording

•Rapidly execute the global Phase 1/1b clinical trial of DMR-001. We aim to rapidly advance the global Phase 1/1b trial of DMR-001 to confirm DMR-001’s differentiated profile, identify a recommended dose for future studies and explore its clinical potential in multiple ET and MF patient populations. We expect the readout of two proof-of-concept datasets from this trial beginning mid-2027 and anticipate these data will support our plans for Phase 3 registration-directed trials for DMR-001.

Current wording

•Rapidly execute the global Phase 1/1b clinical trial of DMR-001. We aim to rapidly advance the global CLARITY-101 trial to confirm DMR-001’s differentiated profile, identify a recommended dose for future studies and explore its clinical potential in multiple ET and MF patient populations. We expect the readout of two proof-of-concept datasets from this trial beginning mid-2027 and anticipate these data will support our plans for Phase 3 registration-directed trials for DMR-001.

Previous wording

•Advance DMR-002 and DMR-003 into clinical development, as part of a comprehensive portfolio strategy. Our differentiated portfolio leverages multiple distinct antibody mechanisms with the potential to address the full spectrum of patients with mutCALR-driven MPNs, regardless of mutation type, disease subtype or disease severity. This includes our lead asset DMR-001, an Fc null antibody, as well as DMR-002, an afucosylated antibody, and DMR-003, a bi-specific T-cell engager. As we advance DMR-001, we plan to make our first regulatory submissions for DMR-002 in the second half of 2026 and for DMR-003 in 2027.

Current wording

•Advance DMR-002 and DMR-003 into clinical development, as part of a comprehensive portfolio strategy. Our differentiated portfolio leverages multiple distinct antibody mechanisms with the potential to address the full spectrum of patients with mutCALR-driven MPNs, regardless of mutation type, disease subtype or disease severity. This includes our lead asset DMR-001, an Fc-null antibody, as well as DMR-002, an afucosylated antibody, and DMR-003, a bi-specific T-cell engager. As we advance DMR-001 in the clinic, we plan to make our first regulatory submissions for DMR-002 in the fourth quarter of 2026 and for DMR-003 in 2027.

Previous wording

On October 7, 2025, Pre-Acquisition Damora entered into the Paragon Option Agreement with Paragon and Paramora. In connection with the Asset Acquisition, we assumed the rights and obligations of Pre-Acquisition Damora under the Paragon Option Agreement. Under the terms of the Paragon Option Agreement, Paragon agreed to perform certain research activities to discover, generate, identify, and characterize one or more antibody candidates directed to certain mutually agreed therapeutic targets of interest (each, a “Research Program”). The Paragon Option Agreement includes mutCALR as the selected target for

Current wording

We received the option to license certain intellectual property rights related to certain research programs (collectively, the "Option"), pursuant to the Antibody Discovery and Option Agreement, dated as of October 7, 2025, by and among Paragon Therapeutics, Inc. (“Paragon”), Paramora Holding LLC (“Paramora”) and Damora Therapeutics, Inc. ("Pre-Acquisition Damora") (the “Paragon Option Agreement”). The Paragon Option Agreement was acquired under the Agreement and Plan of Merger entered into with Pre-Acquisition Damora in November 2025. Under the terms of the Paragon Option Agreement, Paragon agreed to perform certain research activities to discover, generate, identify, and characterize one or more antibody candidates directed to certain mutually agreed therapeutic targets of interest (each, a “Research Program”). The Paragon Option Agreement includes mutCALR as the selected target for two Research Programs, identified as “DMR-001” and “DMR-002,” and mutCALR and CD3 as the selected targets for the third Research Program, identified as “DMR-003.” From time to time, we may choose to add additional targets to the Paragon Option Agreement by mutual agreement with Paragon and Paramora.

Previous wording

Under the Paragon Option Agreement, we are required to pay Paragon a one-time, non-refundable research initiation fee within 30 days following finalization of a Research Plan (as defined in the Paragon Option Agreement) in the amount of $1.25 million for each of DMR-001, DMR-002, and DMR-003. The Research Plans for each of DMR-001, DMR-002, and DMR-003 were completed in December 2025, and we paid the related fees in January 2026. Under the Paragon Option Agreement, on a Research Program-by-Research Program (as defined therein) and product-by-product basis, we are required to make one-time non-refundable milestone payments to Paragon of up to a total of $22.0 million, upon the achievement of certain clinical development and regulatory milestones. On April 28, 2026, we exercised the Option available under the Paragon Option Agreement with respect to the DMR-002 research program.

Current wording

Under the Paragon Option Agreement, we are required to pay Paragon a one-time, non-refundable research initiation fee within 30 days following finalization of a Research Plan (as defined in the Paragon Option Agreement) in the amount of $1.25 million for each of DMR-001, DMR-002, and DMR-003. The Research Plans for each of DMR-001, DMR-002, and DMR-003 were completed in December 2025, and we paid the related fees in January 2026. On November 3, 2026, we entered into a license agreement with Paragon (the “Paragon License Agreement”), pursuant to which Paragon granted us an exclusive, worldwide, royalty-bearing license in the Field (as defined in the Paragon License Agreement), to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting mutCALR under the Research Programs, DMR-001 and DMR-002. Under the Paragon License Agreement, we are obligated to pay Paragon, on a product-by-product basis, up to $22.0 million per licensed product upon the achievement of specified development, clinical and regulatory milestones, inclusive of milestone payments previously made under the Paragon Option Agreement. We have paid Paragon development candidate milestone payments of $1.5 million with respect to each of DMR-001 and DMR-002. We are obligated to make a milestone payment of $2.5 million upon the first dosing of a human in a Phase 1 trial of a licensed product. For additional information, see Part II, Item 5 of this Quarterly Report on Form 10-Q.

Previous wording

In connection with the Asset Acquisition, we assumed the rights and obligations of Pre-Acquisition Damora under the Paragon Option Agreement. Fairmount Funds Management LLC (“Fairmount”) beneficially owns more than 5% of Paragon, appointed Paragon’s board of directors, and has the contractual right to approve the appointment of any executive officers of Paragon. Paramora is an entity formed by Paragon as a vehicle to hold equity in Pre-Acquisition Damora (and as a result of the Asset Acquisition, us) in order to share profits with certain employees of Paragon and will not perform any substantive role under the Paragon Option Agreement other than to receive warrants expected to be granted to Paramora under the Paragon Option Agreement. Three of our directors are affiliated with Fairmount (Peter Harwin, Christopher Cain, Ph.D., and Julianne Bruno) and were appointed in accordance with the Acquisition Agreement. We consider Paragon, Paramora, and Fairmount to be related parties.

Current wording

In connection with the Asset Acquisition, we assumed the rights and obligations of Pre-Acquisition Damora under the Paragon Option Agreement. Fairmount Funds Management LLC (“Fairmount”) beneficially owns more than 5% of Paragon, appointed Paragon’s board of directors, and has the contractual right to approve the appointment of any executive officers of Paragon. Paramora is an entity formed by Paragon as a vehicle to hold equity in Pre-Acquisition Damora (and as a result of the Asset Acquisition, us) in order to share profits with certain employees of Paragon and will not perform any substantive role under the Paragon Option Agreement other than to receive warrants expected to be granted to Paramora under the Paragon Option Agreement. Three of our directors are affiliated with Fairmount (Peter Harwin, Christopher Cain, Ph.D., and Julianne Bruno) and were appointed in accordance with the Agreement and Plan of Merger relating to the Asset Acquisition. We consider Paragon, Paramora, and Fairmount to be related parties.

Previous wording

On February 10, 2026, we filed an automatically effective shelf registration statement (the “Registration Statement”) with the SEC for the issuance of Common Stock, preferred stock, warrants, debt securities, rights and units.

Current wording

On February 10, 2026, we filed an automatically effective shelf registration statement (the “Registration Statement”) with the SEC for the issuance of Ordinary Shares, preferred shares, warrants, debt securities, rights and units, which was amended on August 10, 2026.

Previous wording

On February 10, 2026, we also entered into an underwriting agreement with certain underwriters to issue and sell 16,644,737 shares of our Common Stock, which included the full exercise by the underwriters of their option to purchase an additional 2,171,052 shares, at a public offering price of $19.00 per share. The net proceeds from this offering were approximately $295.5 million, after deducting underwriting discounts and commissions and expenses of the offering. The underwritten offering closed on February 12, 2026.

Current wording

On February 10, 2026, we entered into an underwriting agreement with certain underwriters to issue and sell 16,644,737 Ordinary Shares, which included the full exercise by the underwriters of their option to purchase an additional 2,171,052 shares, at a public offering price of $19.00 per share (the “February 2026 Offering”). The net proceeds from this offering were approximately $295.5 million, after deducting underwriting discounts and commissions and expenses of the offering. The underwritten offering closed on February 12, 2026.

Previous wording

personnel costs, which include salaries, benefits and equity-based compensation expense;

Current wording

personnel costs, which include salaries, benefits and share-based compensation expense;

Previous wording

direct and pass through costs associated with research conducted under the Paragon Option Agreement, including equity-based compensation expense from issuing warrants to Paramora;

Current wording

direct and pass-through costs associated with research conducted under the Paragon Option Agreement, including share-based compensation expense from issuing warrants to Paramora;

Previous wording

For the three and six months ended June 30, 2026, we recognized $5.8 million and $17.8 million, respectively, of research and development expenses in connection with services provided by Paragon under the Paragon Option Agreement in our consolidated statement of operations and comprehensive loss.

Current wording

For the three and nine months ended September 30, 2026, we recognized $7.2 million and $34.5 million, respectively, of research and development expenses in connection with services provided by Paragon under the Paragon Option Agreement in our condensed consolidated statements of operations and comprehensive loss.

Previous wording

We have historically met the requirements to receive a tax credit in Denmark of up to $0.8 million per year for losses resulting from research and development costs of up to approximately $3.9 million per year. The tax credit is reported as a reduction to research and development expense in the consolidated statements of operations. We recorded a tax credit of $0.4 million in the six months ended June 30, 2025. We recorded a tax credit of $0.1 million in the six months ended June 30, 2026. The credits are available the following year, in 2027 and 2026, respectively.

Current wording

We have historically met the requirements to receive a tax credit in Denmark of up to $0.8 million per year for losses resulting from research and development costs of up to approximately $3.9 million per year. The tax credit is reported as a reduction to research and development expense in the consolidated statements of operations. We recorded a tax credit of $0.7 million in the nine months ended September 30, 2025. We recorded a tax credit of $0.1 million in the nine months ended September 30, 2026. The credits are available the following year, in 2026 and 2027, respectively.

Previous wording

Because of the numerous risks and uncertainties associated with product development and the current stage of development of our product candidates and programs, we cannot reasonably estimate or know the nature, timing and estimated costs necessary to complete the remainder of the development of our product candidates or programs through commercialization. We are also unable to predict if, when, or to what extent we will obtain approval and generate revenues from the commercialization and sale of our product candidates. The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including:

Current wording

Because of the numerous risks and uncertainties associated with product development and the current stage of development of our product candidates and programs, we cannot reasonably estimate or know the nature, timing and estimated costs necessary to complete the remainder of the development of our product candidates or programs through commercialization. We are also unable to predict if, when, or to what extent we will obtain approval and generate revenues from the commercialization and sale of our product candidates. The duration, costs and timing of preclinical studies, clinical trials, development and commercialization of our product candidates will depend on a variety of factors, including:

Previous wording

the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our product candidates, including DMR-001, DMR-002, DMR-003 and any our other product candidates we develop in the future;

Current wording

the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our product candidates, including DMR-001, DMR-002, DMR-003 and any other product candidates we develop in the future;

Previous wording

Our general and administrative expenses consist primarily of personnel costs, depreciation expense and other expenses for outside professional services, including legal, human resources, audit and accounting services and facility-related fees not otherwise included in research and development expenses. Personnel costs consist of salaries, benefits and stock-based compensation expense, for our personnel in executive, finance and accounting, business operations and other administrative functions. We expect that our general and administrative expenses will increase substantially for the foreseeable future as we increase our headcount and further establish our office space to support our expected growth. We also expect to incur increased expenses as a public company, including increased costs of accounting, audit, legal, regulatory and tax related services associated with maintaining compliance with SEC requirements, additional director and officer insurance costs, and investor and public relations costs. We also expect to incur additional intellectual property-related expenses as we file patent applications to protect innovations arising from our research and development activities.

Current wording

Our general and administrative expenses consist primarily of personnel costs, depreciation expense and other expenses for outside professional services, including legal, human resources, audit and accounting services and facility-related fees not otherwise included in research and development expenses. Personnel costs consist of salaries, benefits and share-based compensation expense, for our personnel in executive, finance and accounting, business operations and other administrative functions. We expect that our general and administrative expenses will increase substantially for the foreseeable future as we increase our headcount and further establish our office space to support our expected growth. We also expect to incur increased expenses as a public company, including increased costs of accounting, audit, legal, regulatory and tax related services associated with maintaining compliance with SEC requirements, additional director and officer insurance costs, and investor and public relations costs. We also expect to incur additional intellectual property-related expenses as we file patent applications to protect innovations arising from our research and development activities.

Previous wording

Interest income: The interest income earned on our cash and cash equivalents is recorded in our statements of operations.

Current wording

Interest income: The interest income earned on our cash, cash equivalents and marketable securities is recorded in our statements of operations.

Previous wording

Research and development expenses were $25.5 million for the three months ended June 30, 2026, compared to $1.5 million for the three months ended June 30, 2025. The increase of $24.1 million was primarily related to increased preclinical studies and clinical trial-related expenses of $4.4 million, all of which related to costs incurred by Paragon under the Paragon Option Agreement, costs related to the Paramora Warrant Obligation of $4.5 million, increased chemistry, manufacturing and control (“CMC”) activities of $9.1 million, increased personnel costs of $2.8 million (of which $1.5 million relates to stock-based compensation expense) and increased consulting related costs and other research and development costs of $3.3 million.

Current wording

Research and development expenses were $25.5 million for the three months ended September 30, 2026, compared to $1.4 million for the three months ended September 30, 2025. The increase of $24.1 million was primarily related to increased preclinical studies and clinical trial-related expenses of $7.5 million, increased chemistry, manufacturing and control (“CMC”) activities of $7.5 million, increased personnel costs of $4.7 million (of which $2.2 million relates to share-based compensation expense), costs related to the Paramora Warrant Obligation of $2.3 million, and increased consulting related costs and other research and development costs of $2.1 million. Of these research and development expenses, $7.2 million related to services provided by Paragon under the Paragon Option Agreement, including $2.3 million related to the Paramora Warrant Obligation.

Previous wording

General and administrative expenses were $9.5 million for the three months ended June 30, 2026, compared to $2.0 million for the three months ended June 30, 2025. The increase of $7.5 million was primarily related to increased personnel costs of $1.3 million, increased stock-based compensation expense of $4.5 million, increased professional fees of $0.8 million, and increased other general and administrative costs of $0.9 million.

Current wording

General and administrative expenses were $11.4 million for the three months ended September 30, 2026, compared to $1.7 million for the three months ended September 30, 2025. The increase of $9.6 million was primarily related to increased personnel costs of $7.2 million (of which $5.2 million relates to share-based compensation expense), increased professional fees of $1.6 million, and increased other general and administrative costs of $0.8 million, including travel, insurance, and state taxes.

Previous wording

The following sets forth our results of operations for the six months ended June 30, 2026 and 2025:

Current wording

The following sets forth our results of operations for the nine months ended September 30, 2026 and 2025:

Previous wording

Research and development expenses were $49.3 million for the six months ended June 30, 2026, compared to $2.1 million for the six months ended June 30, 2025. The increase of $47.2 million was primarily related to increased preclinical studies and clinical trial-related expenses of $7.9 million, all of which related to costs incurred by Paragon under the Paragon Option Agreement, costs related to the Paramora Warrant Obligation of $9.5 million, increased chemistry, manufacturing and control (“CMC”) activities of $18.8 million, increased personnel costs of $4.8 million (of which $2.8 million relates to stock-based compensation expense) and increased consulting related costs and other research and development costs of $6.2 million.

Current wording

Research and development expenses were $74.8 million for the nine months ended September 30, 2026, compared to $3.6 million for the nine months ended September 30, 2025. The increase of $71.2 million was primarily related to increased CMC activities of $26.2 million, increased preclinical studies and clinical trial-related expenses of $15.4 million, costs related to the Paramora Warrant Obligation of $11.9 million, increased personnel costs of $9.5 million (of which $5.0 million relates to share-based compensation expense) and increased consulting related costs and other research and development costs of $8.3 million. Of these research and development expenses, $34.5 million related to services provided by Paragon under the Paragon Option Agreement, including $11.9 million related to the Paramora Warrant Obligation.

Previous wording

General and administrative expenses were $16.5 million for the six months ended June 30, 2026, compared to $3.9 million for the six months ended June 30, 2025. The increase of $12.6 million was primarily related to increased personnel costs of $3.0 million, increased stock-based compensation costs of $6.1 million, increased professional fees of $2.4 million, and increased other general and administrative costs of $1.1 million.

Current wording

General and administrative expenses were $27.9 million for the nine months ended September 30, 2026, compared to $5.6 million for the nine months ended September 30, 2025. The increase of $22.3 million was primarily related to increased personnel costs of $16.4 million (of which $11.3 million relates to share-based compensation expense), increased professional fees of $4.2 million, and increased other general and administrative costs of $1.7 million, including travel, insurance, and state taxes.

Previous wording

Our operations to date have been financed primarily through our initial public offering, the sale and issuance of Common Stock and preferred shares and, prior to becoming a public company, convertible notes. During the six months ended June 30, 2026, we entered into an underwriting agreement in February 2026 with certain underwriters to issue and sell 16,644,737 shares of our Common Stock, which included the full exercise by the underwriters of their option to purchase an additional 2,171,052 shares, at a public offering price of $19.00 per share. The net proceeds from this offering were approximately $295.5 million, after deducting underwriting discounts and commissions and expenses of the offering. In February 2026, we entered into the ATM Agreement, which was amended on August 10, 2026, pursuant to which we may sell, from time-to-time, Ordinary Shares (formerly Common Stock) under an ATM offering program for up to $150.0 million. As of June 30, 2026, we sold an aggregate of 1,240,400 shares of our Common Stock under the ATM offering program to a single institutional investor at a price per share of $24.16 resulting in net proceeds of $29.3 million.

Current wording

Our operations to date have been financed primarily through our initial public offering, the sale and issuance of Ordinary Shares and preferred shares and, prior to becoming a public company, convertible notes. During the nine months ended September 30, 2026, we entered into an underwriting agreement in February 2026 with certain underwriters to issue and sell 16,644,737 Ordinary Shares, which included the full exercise by the underwriters of their option to purchase an additional 2,171,052 shares, at a public offering price of $19.00 per share. The net proceeds from this offering were approximately $295.5 million, after deducting underwriting discounts and commissions and expenses of the offering. In February 2026, we entered into the ATM Agreement, which was amended on August 10, 2026, pursuant to which we may sell, from time-to-time, Ordinary Shares under an ATM offering program for up to $150.0 million. During the three months ended September 30, 2026, we sold an aggregate of 167,423 Ordinary Shares under the ATM offering program at a weighted-average price per share of $31.59 resulting in net proceeds of $5.1 million. During the nine months ended September 30, 2026, we sold an aggregate of

Previous wording

Since inception, we have had significant operating losses. Our net losses were $31.2 million and $3.4 million for the three months ended June 30, 2026 and 2025, respectively, and $59.0 million and $6.0 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $546.3 million and $540.5 million in cash and cash equivalents. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Current wording

Since inception, we have had significant operating losses. Our net losses were $32.0 million and $3.1 million for the three months ended September 30, 2026 and 2025, respectively, and $90.9 million and $9.1 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $578.3 million and $528.5 million in cash, cash equivalents and marketable securities. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Previous wording

Cash used in operating activities of $42.5 million during the six months ended June 30, 2026 was attributable to our net loss of $59.0 million, a net decrease of $7.1 million in our working capital, and a net increase in non-cash items of $9.3 million principally with respect to non-cash stock-based compensation.

Current wording

Cash used in operating activities of $59.7 million during the nine months ended September 30, 2026 was attributable to our net loss of $90.9 million, partially offset by net cash provided by changes in our operating assets and liabilities of $15.1 million and non-cash items of $16.1 million principally with respect to non-cash share-based compensation.

Previous wording

Cash used in operating activities of $4.7 million during the six months ended June 30, 2025 was attributable to our net loss of $6.0 million, offset by a net increase in non-cash items of $0.4 million of non-cash stock-based compensation and a net decrease of $0.1 million in our working capital.

Current wording

Cash used in operating activities of $7.3 million during the nine months ended September 30, 2025 was primarily attributable to our net loss of $9.1 million, partially offset by net cash provided by changes in our assets and liabilities of $1.2 million and non-cash items of $0.6 million principally with respect to share-based compensation.

Previous wording

We had no financing activities for the six months ended June 30, 2025.

Current wording

We had no financing activities for the nine months ended September 30, 2025.

Previous wording

Based on current estimates of our expenses going forward, we believe that our existing cash and cash equivalents of $540.5 million as of June 30, 2026 will be sufficient to fund our operations into the second half of 2029. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Current wording

Based on current estimates of our expenses going forward, we believe that our existing cash, cash equivalents and marketable securities of $528.5 million as of September 30, 2026 will be sufficient to fund our operations into the second half of 2029. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Previous wording

We have issued stock-based compensation awards through the granting of stock awards, which generally vest over a four-year period. We account for stock-based compensation in accordance with Accounting Standards Codification (“ASC”) 718, Compensation-Stock Compensation (“ASC 718”). In accordance with ASC 718, compensation cost is measured at estimated fair value and is recognized as compensation expense over the vesting period during which service is provided in exchange for the award.

Current wording

We have issued share-based compensation awards through the granting of share awards, which generally vest over a three- to four-year period. We account for share-based compensation in accordance with Accounting Standards Codification (“ASC”) 718, Compensation-Stock Compensation (“ASC 718”). In accordance with ASC 718, compensation cost is measured at estimated fair value and is recognized as compensation expense over the vesting period during which service is provided in exchange for the award.

Previous wording

We use a Black-Scholes option pricing model to determine fair value of our stock options. The Black-Scholes option pricing model includes various assumptions, including the fair value of common shares, expected life of stock options, the expected volatility based on the historical volatility of a publicly traded set of peer companies and the expected risk-free interest rate. These assumptions reflect our best estimates, but they involve inherent uncertainties based on market conditions generally outside our control. As a result, if other assumptions had been used, stock-based compensation cost could have been materially impacted. Furthermore, if we use different assumptions for future grants, share-based compensation cost could be materially impacted in future periods.

Current wording

We use a Black-Scholes option pricing model to determine fair value of our share options. The Black-Scholes option pricing model includes various assumptions, including the fair value of Ordinary Shares, expected life of share options, the expected volatility based on the historical volatility of a publicly traded set of peer companies and the expected risk-free interest rate. These assumptions reflect our best estimates, but they involve inherent uncertainties based on market conditions generally outside our control. As a result, if other assumptions had been used, share-based compensation cost could have been materially impacted. Furthermore, if we use different assumptions for future grants, share-based compensation cost could be materially impacted in future periods.

Previous wording

The fair value of our awards in the three months ended June 30, 2026 has been estimated using Black-Scholes based on the following assumptions: term of 6.1 years; volatility of 84.1%; risk-free rate of 4.0%; and no expectation of dividends. The fair value of our awards in the three months ended June 30, 2025 has been estimated using Black-Scholes based on the following assumptions: term of 5.9 years; volatility of 95.9%; risk-free rate of 4.4%; and no expectation of dividends.

Current wording

The fair value of our awards in the nine months ended September 30, 2026 has been estimated using Black-Scholes based on the following assumptions: term of 6.1 years; volatility of 83.8%; risk-free rate of 4.1%; and no expectation of dividends. The fair value of our awards in the nine months ended September 30, 2025 has been estimated using Black-Scholes based on the following assumptions: term of 5.9 years; volatility of 95.9%; risk-free rate of 4.4%; and no expectation of dividends.

Previous wording

We will continue to use judgment in evaluating the assumptions utilized for our equity-based compensation expense calculations on a prospective basis. In addition to the assumptions used in the Black-Scholes model, the amount of equity-based compensation expense we recognize in our consolidated financial statements includes stock option forfeitures as they occurred. We recognize forfeitures as they occur, and the compensation expense is reversed in the period that the forfeiture occurs.

Current wording

We will continue to use judgment in evaluating the assumptions utilized for our share-based compensation expense calculations on a prospective basis. In addition to the assumptions used in the Black-Scholes model, the amount of share-based compensation expense we recognize in our consolidated financial statements reflects share option forfeitures, which we recognize as they occur, and the compensation expense is reversed in the period that the forfeiture occurs.

Previous wording

Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating losses and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted statutory tax rates expected to apply to taxable income in the jurisdictions and years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

Current wording

Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted statutory tax rates expected to apply to taxable income in the jurisdictions and years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

Previous wording

Refer to Note 2, “Summary of Significant Accounting Policies,” in the accompanying notes to our consolidated financial statements for the three and six months ended June 30, 2026 and 2025 for a discussion of recent accounting pronouncements.

Current wording

Refer to Note 2, “Summary of Significant Accounting Policies,” in the accompanying notes to our consolidated financial statements for the three and nine months ended September 30, 2026 and 2025 for a discussion of recent accounting pronouncements.