Anteris Technologies Global Corp.

DESCRIPTION OF BUSINESS

Anteris Technologies Global Corp. (“ATGC,” “Anteris,” “Company,” “we,” “us,” or “our”) was incorporated in Delaware on January 29, 2024. ATGC was formed for the purpose of reorganizing the operations of Anteris Technologies Pty Ltd (“ATPL”, formerly Anteris Technologies Ltd), an Australian public company originally registered in Western Australia, Australia and listed on the Australian Securities Exchange (“ASX”), into a structure whereby the ultimate parent company would be a Delaware corporation (the “reverse recapitalization”).

On December 16, 2024, the Company received all the issued and outstanding shares of ATPL pursuant to a scheme of arrangement under Australian law between ATPL and its shareholders (the “Scheme”) under Part 5.1 of the Australian Corporations Act 2001 (Cth) (the “Corporations Act”). Contemporaneously with implementation of the Scheme, ATPL cancelled all existing options it had outstanding in exchange for ATGC issuing replacement options to acquire shares of ATGC’s common stock, par value $0.0001 per share (“Common Stock”) pursuant to a scheme of arrangement between ATPL and its option holders (the “Option Scheme”) under Part 5.1 of the Corporations Act.

Prior to completion of the reverse recapitalization, ATGC had no business or operations and following completion of the reverse recapitalization, the business and operations of ATGC consist solely of the business and operations of ATPL and its subsidiaries. As a result of the reverse recapitalization, ATGC became the parent company of ATPL and, for financial reporting purposes, the historical financial statements of ATPL became the historical financial statements of ATGC as a continuation of the predecessor.

On December 16, 2024, the Company completed the reverse recapitalization and an initial public offering (“IPO”) of 14,800,000 shares of Common Stock.

ATGC’s principal activities consist of:

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Continued research and development (“R&D”) of the DurAVR® Transcatheter Heart Valve (“THV”) System consisting of a single-piece biomimetic valve made with our proprietary ADAPT® tissue-enhancing technology and deployed with our balloon expandable ComASUR® Delivery System, to address unmet medical needs in the treatment of aortic stenosis. The DurAVR® THV, with its single piece, native-shaped biomimetic design is built to mimic the performance of a healthy aortic valve and to restore normal laminar blood flow. This new class of technology can be used to treat new aortic stenosis patients and to treat aortic stenosis patients where their current bioprosthetic aortic valve is failing (“valve-in-valve”).

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Conducting the randomized global pivotal study (the “PARADIGM Trial”), designed to generate the clinical evidence required to support a Premarket Approval (“PMA”) application in the United States and a parallel CE Mark approval in Europe.

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The co-development with v2vmedtech, inc. (“v2v”), of an innovative heart valve repair device for the minimally invasive treatment of mitral and tricuspid valve regurgitation (also known as a leaky valve).

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). These policies have been consistently applied to all the periods presented, unless otherwise stated. The accompanying condensed consolidated financial statements of the Company are unaudited. In the opinion of management, all adjustments necessary for a fair statement of results of operations, cash flows, and financial position have been made. The results of operations for the three and nine months ended September 30, 2025 and 2024 are not necessarily indicative of results that may be expected for the full year or any other subsequent interim period.

Unless noted otherwise, all dollar amounts are in thousands of United States dollars (“U.S. dollars” or “$”). Some amounts may not reconcile due to rounding.

For the three and nine months ended September 30, 2024, the condensed consolidated financial statements reflect the consolidated results of operations, comprehensive loss, cash flows, and changes in equity of ATPL and its wholly-owned subsidiaries. The Condensed Consolidated Balance Sheet as of December 31, 2024 presents the financial condition of the Company and its consolidated subsidiaries.

In accordance with ASC 805, Business Combinations, ATPL’s historical equity has been retrospectively restated for all periods up to December 16, 2024, the closing date of the reverse recapitalization (the “Closing Date”), to reflect the number of shares of Common Stock issued to legacy ATPL shareholders in connection with the reverse recapitalization. Additionally, the par value of Common Stock has been restated to align with the post-transaction capital structure.

The Company is an emerging growth company (“EGC”), as defined in Section 2(a) of the Securities Act of 1933, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), which permits the Company to utilize an extended transition period to comply with new or revised accounting standards applicable to public companies.

The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management bases its judgments, estimates and assumptions on historical experience and on other various factors, including expectations of future events that management believe to be reasonable under the circumstances. Actual results could differ from those estimates due to risks and uncertainties.

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

The accounting policies adopted in the preparation of the condensed consolidated financial statements are consistent with those adopted and disclosed in the Group’s (defined below) financial statements for the year ended December 31, 2024, and therefore these condensed consolidated financial statements do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes for the year ended December 31, 2024 as included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 12, 2025, and amended on April 29, 2025 (as amended, the “Annual Report”).

There have been no material changes to the Company's significant accounting policies from those described in the consolidated financial statements for the year ended December 31, 2024 as included in the Annual Report.

(a)

Principles of consolidation

The condensed consolidated financial statements include the accounts of ATGC, its wholly-owned subsidiaries, entities for which the Company has a controlling financial interest, as well as any variable interest entities (“VIEs”) for which ATGC has been determined to be the primary beneficiary. ATGC and its subsidiaries together are referred to in these financial statements as the “Group.”

Subsidiaries are all those entities over which the Group has control. Control is the power to govern the financial and operating policies of an entity. All subsidiaries of ATGC have a reporting year end of December 31.

Intercompany transactions, balances and unrealized gains or losses on transactions between entities in the Group are eliminated.

(b)

Recently Adopted Accounting Standards

In June 2022, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2022-03, Fair Value Measurement (Topic 820) Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. ASU 2022-03 clarifies guidance for fair value measurement of an equity security subject to a contractual sale restriction and establishes new disclosure requirements for such equity securities. This ASU was effective January 1, 2025 for smaller reporting companies. The Company has assessed the impact of adopting this accounting guidance and has determined that it does not impact the fair value measurement of our existing equity securities. Nevertheless, the Company will apply the guidance and incorporate the new required disclosures in future filings as needed.

(c)

New Accounting Standards Not Yet Adopted

The FASB has issued several new accounting pronouncements during the first nine months of 2025 which the Company has reviewed. Based on this assessment, the Company has determined that there are no new accounting pronouncements issued but not yet adopted that would have a material impact on the Company's financial position, results of operations, or cash flows.

For further details on new accounting pronouncements issued in prior years but not yet adopted, refer to Note 2(aa) in the consolidated financial statements for the year ended December 31, 2024 as included in the Annual Report.

GOING CONCERN

The condensed consolidated financial statements have been prepared on the going concern basis, which contemplates continuity of normal business activities and realization of assets and discharges of liabilities in the ordinary course of business. As disclosed in the financial statements, the Group incurred loss after income tax of $65.2 million and had net cash outflows from operating activities of $59.3 million for the nine months ended September 30, 2025. As of September 30, 2025, the Group had a cash balance of $9.1 million.

The Group has been primarily investing in research and development activities associated with the continuing development and proposed commercialization of the DurAVR® THV System. During the nine months ended September 30, 2025, amounts invested in research and development activities and general operations exceeded cash inflows associated with sales of ADAPT® tissue products plus research and development tax incentives from the Australian government.

The Group anticipates that additional funds will need to be generated in order to achieve the Group’s long-term goals and complete the research and development of current products. The Group does not expect to generate significant revenue until after regulatory approvals to commercially sell the DurAVR® THV System have been obtained and sales have commenced. The Group therefore expects to continue incurring losses in the near future.

To become and remain profitable, the Group has commenced conducting the global pivotal PARADIGM Trial and will seek to obtain regulatory approvals with the aim of commercializing, manufacturing and supplying products, including the DurAVR® THV System, that generate significant revenue. For medtech devices, including the DurAVR® THV System, this will require the Group to successfully complete product clinical trials, develop and expand quality management systems, obtain regulatory approval post completion of clinical trials, expand manufacturing and distribution capabilities and comply with ongoing post-market regulatory requirements.

Prior to achieving commercialization, the Group will periodically require capital infusion through the issuance of shares of Common Stock, debt instruments, or other securities that can be converted into Common Stock. The future success of the Company is dependent on its ability to attract additional capital and ultimately, upon its ability to develop future profitable operations. There can be no assurance that the Company will be successful in obtaining such financing, or that it will attain positive cash flow from operations. If the Group is unable to obtain adequate capital resources to fund operations, it may be necessary to delay, scale back or eliminate some or all of its operations, which may have a material adverse effect on the business, results of operations and its ability to operate as a going concern. However, the Group has established a track record of successfully raising new capital and entering into debt facilities. This includes completing an IPO in the fourth quarter of 2024 of 14,800,000 shares of Common Stock for gross proceeds of $88.8 million before underwriting discounts, commissions and other transaction costs, as well as entering into binding subscription agreements and confirmation letters in October 2025 for a private placement totaling gross proceeds of $25.2 million, comprised of Common Stock and CHESS Depositary Interests (“CDIs”), both with accompanying warrants. Refer to Note 12 Subsequent Events for details.

The above conditions give rise to substantial doubt as to whether the Group will be able to continue as a going concern for one year from the issuance date of these financial statements.

The Company’s board of directors (the “Board”) and management believe that the going concern basis of preparation is appropriate for the reasons outlined above.

Should the Group be unable to continue as a going concern, it may be required to realize its assets and extinguish its liabilities other than in the ordinary course of business, and at amounts that differ from those stated in the financial statements. These financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts or classification of liabilities and appropriate disclosures that may be necessary should the Group be unable to continue as a going concern.

INCOME TAX

The Company’s provision for interim periods is determined using an estimate of the annual effective tax rate, adjusted for discrete items arising in that period. The Company’s effective tax rate differs from the U.S. statutory tax rate primarily due to valuation allowances on its deferred tax assets as it is more likely than not that some, or all, of the Company’s deferred tax assets will not be realized. There wasno income tax benefit for the nine months ended September 30, 2025 and September 30, 2024.

Deferred tax assets and liabilities are determined based upon the differences between the unaudited condensed consolidated financial statements carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. The Company has provided a full valuation allowance against the net deferred tax assets as the Company has determined that it was more likely than not that the Company would not realize the benefits of net deferred tax assets.

ACCRUED AND OTHER LIABILITIES

EQUITY

Share Capital

For information on the pertinent rights and privileges of the Company’s outstanding shares, refer to Note 14 Equity in the audited consolidated financial statements for the year ended December 31, 2024 as included in the Annual Report.

The following details issuance of Common Stock in the nine months ended September 30, 2025:

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In January 2025, in connection with the IPO which initially closed on December 16, 2024, TD Cowen, Barclays and Cantor (in their capacity as the underwriters’ representatives in the IPO) partially exercised the over-allotment option granted by the Company, pursuant to which the Company issued and sold an additional 78,481 shares of Common Stock at the purchase price of $6.00 per share for incremental gross proceeds of $0.5 million.

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During the three months ended March 31, 2025,831 unlisted options issued under the Employee Incentive Plan were exercised. These options had a weighted average exercise price of $3.99 per share.

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In March 2025, the following directors exercised options:

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Mr. John Seaberg exercised 40,000 options with an exercise price $7.13 per option and as a result was issued 3,852 shares of Common Stock. The intrinsic value of the 40,000 options represented the consideration for the issuance of the 3,852 shares.

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Mr. Wayne Paterson exercised 233,000 options with an exercise price $7.13 per option and as a result was issued 12,607 shares of Common Stock. The net intrinsic value of the 233,000 options (after deduction of taxes and withholdings) represented the consideration for the issuance of the 12,607 shares.

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Mr. Stephen Denaro exercised 16,500 options with an exercise price of $6.96 per share (AUD $11.20) raising $114,833.

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During the three months ended March 31, 2025, external investors exercised 10,000 options for $6.22 per share (AUD $10.00), for gross proceeds of $0.1 million.

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During the three months ended June 30, 2025,283 unlisted options issued under the Employee Incentive Plan were exercised. These options had a weighted average exercise price of $2.39 per share.

EQUITY (continued)

For the comparable nine-month period ended September 30, 2024, ATPL issued the following ordinary shares:

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In January 2024,667 unlisted options issued under the Employee Incentive Plan were exercised. These options had an exercise price of $5.67 equivalent per share (AUD $8.60).

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In January 2024, external investors exercised 12,500 unlisted options for $6.70 equivalent per share (AUD $10.00) for gross proceeds of $0.1 million.

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In March 2024, external investors exercised 262,000 unlisted options for $6.59 equivalent per share (AUD $10.00) for gross proceeds of $1.7 million.

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In April 2024,1,000,000 new shares were issued to various sophisticated and professional investors at $14.74 equivalent per share (AUD $23.00) for total consideration of $14.7 million.

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In May 2024, external investors exercised 12,000 unlisted options for $6.60 equivalent per share (AUD $10.00) for gross proceeds of $0.1 million.

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In July 2024,1,875,000 new shares were issued to various sophisticated and professional investors at $10.49 equivalent per share (AUD $16.00) for total consideration of $19,668,000.

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In July 2024,41,000 new shares were issued to a consultant for services provided. The equivalent price per share was $10.49 (AUD $16.00).

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In September 2024, external investors exercised 1,500 unlisted options for $6.84 equivalent per share (AUD $10.00) for gross proceeds of $10,300.

Subsequent to the end of the reporting period, the Company issued (i)2,346,936 shares of Common Stock, (ii) warrants to purchase 2,346,936 shares of Common Stock, (iii)2,788,064 CDIs and (iv) warrants to purchase 3,038,064 CDIs. Refer to Note 12 Subsequent Events for details.

LOSS PER SHARE

The below table presents the computation of basic and diluted loss per share:

Subsequent to the end of the reporting period, the Company issued (i)2,346,936 shares of Common Stock, (ii) warrants to purchase 2,346,936 shares of Common Stock, (iii)2,788,064 CDIs and (iv) warrants to purchase 3,038,064 CDIs. Refer to Note 12Subsequent Events for details. The issuance of the additional shares of Common Stock has a material impact on the Company’s loss per share calculations. After the issuance, the basic and diluted loss per share for the three months ended September 30, 2025 would have been a loss of $0.54 per share, reflecting a change of $0.08 per share. The basic and diluted loss per share for the nine months ended September 30, 2025 would have been $1.58 per share, reflecting a change of $0.22 per share.

The financial statements for the period ended September 30, 2025 do not reflect the effects of this issuance, which will be included in the financial statements for the subsequent period.

STOCK-BASED COMPENSATION

(a)

Stock-based compensation expense

The following table presents the components and classification of stock-based compensation expense recognized for stock options, cash-settled stock-based payments rights (“SPPs”), restricted stock units (“RSUs”) and shares of Common Stock issued to employees, directors and consultants:

As of September 30, 2025, there was $5.6 million of total unrecognized compensation cost related to non-vested stock-based compensation arrangements granted. That cost is expected to be recognized over a weighted-average period of 1.4 years.

(b)

Stock-based awards activity

Director options

No options were issued to directors during the three or nine months ended September 30, 2025.

In March 2025,289,500 director options were exercised, resulting in the issuance of 32,959 shares of Common Stock. Refer to Note 6 Equity.

On June 19, 2024, following approval by ATPL shareholders at the Annual General Meeting on May 29, 2024, ATPL issued options to purchase an aggregate of shares with an exercise price of $15.34 equivalent (AUD $23.00) per share to the following directors:

John Seaberg (Chair) –75,000 options

Wayne Paterson (CEO and Managing Director) –300,000 options

Stephen Denaro (Non-Executive Director and Company Secretary) –50,000 options

Dr Wenyi Gu (Non-Executive Director) –50,000 options

The above director share options expire after 5 years and vest inthree tranches on the completion of at least 12,24 and 36 months of service from the date of issue. These options were awarded as part of the existing Employee Incentive Plan.

Following Dr W. Gu’s resignation on June 6, 2025,50,000 unvested options were forfeited in accordance with the original terms of the awards.

Director RSUs

On August 19, 2025, in accordance with the Company’s Non-Employee Director Compensation Policy, the Company contingently granted RSUs with a grant date fair value of $250,000 to each of the Company’s new directors, Greg Moss and David Roberts. Each grant is subject to stockholder approval in accordance with the rules of the ASX. Each grant of RSU will vest inthree tranches on the completion of at least 12,24 and 36 months of service from the date of contingent grant.

As of September 30, 2025, no stock-based compensation expense has been recognized for these RSUs, as the grant date has not been established under ASC 718.

Employee stock options

During the three and nine months ended September 30, 2025,21,500 employee stock options were issued. During the same periods,69,166 and 92,166 employee stock options were cancelled due to expiration or forfeiture, respectively.

During the three and nine months ended September 30, 2024, the Company issued 9,450 and 167,950 employee stock options, respectively. During the same periods,1,000 and 1,584 employee stock options were cancelled due to expiration or forfeiture, respectively.

STOCK-BASED COMPENSATION (continued)

Consultant options and share grants

No options or shares were issued to consultants during the three or nine months ended September 30, 2025. In February 2025,500,000 stock options held by consultants expired unexercised. An additional 500,000 consultant-held options expired unexercised in September 2025.

During the three and nine months ended September 30, 2024,41,000 ordinary shares were issued to a consultant as compensation for services received.

RSUs

The number of RSUs granted to employees under the Company’s Equity Incentive Plan during the three and nine months ended September 30, 2025 were 19,500 and 546,550, respectively. These RSUs generally vest over a service period ofthree years, subject to continued employment, and are settled in shares of Common Stock upon vesting.

A total of 44,350 and 83,650 RSUs were forfeited upon cessation of employment during the three and nine months ended September 30, 2025, respectively.

No RSUs were granted during the three or nine months ended September 30, 2024.

SPP rights

No SPP rights were issued during the three or nine months ended September 30, 2025 or 2024. The carrying amount of the SPP liabilities was $0.2 million and $0.2 million as of September 30, 2025 and December 31, 2024, respectively.

On September 13, 2025,283,332 SPP rights were forfeited and cancelled as the share price on the vesting date was less than the base price.

(c)

Fair Value Disclosures

Director options

The following table provides the fair value of the stock-based payments options granted to directors during the periods indicated and the inputs used in the Black-Scholes model.

Employee options

The following table provides the weighted average fair value of options granted to employees during the periods indicated and the related weighted average inputs (based on number of options granted) used in the Black-Scholes model.

STOCK-BASED COMPENSATION (continued)

RSUs

The weighted-average grant date fair value of RSUs granted during the three and nine months ended September 30, 2025 was $3.80 and $3.46 per RSU, respectively. The fair value of the RSUs was determined based on the market value of the Common Stock on the grant date, which represents the fair value of the underlying shares.

SPP rights

The inputs used in the measurement of the fair values at reporting date of the SPP rights were as follows:

VARIABLE INTEREST ENTITY

At each reporting period, the Company reassesses whether it remains the primary beneficiary for VIEs consolidated under the VIE model. Pursuant to the guidance under ASC 810, the Company determined that v2vmedtech, inc. (“v2v”) is a VIE and that the Company is the primary beneficiary of v2v. This determination is based on the Company having both power over the most significant activities of v2v, primarily through appointing and holding a majority of v2v’s board of directors and certain benefits through equity ownership. Therefore, the Company consolidated v2v from the acquisition date of its equity interest.

The following table presents the assets and liabilities for VIEs:

Included in other current liabilities is a loan to v2v from v2v’s parent entity amounting to $20,100 as of September 30, 2025 and $20,800 as of December 31, 2024. This loan has been provided to support v2v’s working capital needs. It is unsecured and repayable on demand. This balance is eliminated in the condensed consolidated financial statements. v2v is wholly financed by the Group. The Group contributed $1.0 million and $1.7 million to v2v to finance its operations during the three months and nine months ended September 30, 2025.

VARIABLE INTEREST ENTITY (continued)

Non-controlling Interests

The Company recognizes non-controlling interests related to v2v and provides a roll forward of the non-controlling interests balance, as follows:

COMMITMENTS AND CONTINGENCIES

As of September 30, 2025, the Group had commitments to purchase $0.3 million of plant and equipment, as compared to $0.3 million at December 31, 2024.

The Company is involved in various ongoing proceedings arising in the normal course of business, including proceedings related to product, labor, intellectual property and other matters.

Contingent liabilities

The Group has evaluated its contingent liabilities and determined that there are no material contingent liabilities requiring disclosure as of September 30, 2025.

SEGMENT REPORTING

(a)

Description of segments

Segment information is presented using a management approach, meaning that segment information is provided on the same basis as information is used for internal reporting purposes by the chief operating decision maker (“CODM”) which is the Company’s Vice Chairman and CEO, who makes key strategic decisions. The CODM is responsible for the allocation of resources and assessing the performance of the Group. Management has determined that the activities of the business as reviewed by the CODM areone segment, being the development and commercialization of the ADAPT® anti-calcification tissue. This is focused on the DurAVR® THV System.

(b)

Segment information

The revenue and cost information relating to all of the ADAPT® products including both the DurAVR® THV System and regenerative tissue products are regularly reviewed by the CODM on an aggregate basis.

The CODM assesses performance and allocates resources based on the Company’s Condensed Consolidated Statements of Operations and key components and processes of the Company’s operations are managed centrally. Segment asset information is not used by the CODM to allocate resources. As a single reportable segment entity, the Company’s segment performance measure is net income or loss.

No detailed asset information by reportable segment has been reported given that the single segment’s information is already presented in the Condensed Consolidated Balance Sheets. Refer to the Condensed Consolidated Statements of Cash Flows for significant non-cash items and total expenditure for additions of long-lived assets.

SEGMENT REPORTING (continued)

(c)

Geographic information

Segment revenues (net sales) have been based on the geographic location of the customers taking possession of the products.

(d)

Major customers

The following table summarizes revenues from major customers that individually accounted for 10% or more of the Company's total revenues.

The total amounts outstanding from these customers was $0.2 million and $0.2 million as of September 30, 2025 and December 31, 2024, respectively.

SUBSEQUENT EVENTS

Management has evaluated the impact of subsequent events through November 12, 2025.

Capital Raising Activities

On or about October 23, 2025, the Company entered into (i) subscription agreements (the “Subscription Agreements”) with certain investors, pursuant to which the Company issued and sold an aggregate of 2,346,936 shares of Common Stock (the “Shares”), each with an accompanying warrant (a “Common Stock Warrant”) to purchaseone share of Common Stock, at a price of US$4.90 per share of Common Stock and accompanying Common Stock Warrant (the “Common Stock Offering”), and (ii) confirmation letters (the “Confirmation Letters”) with certain investors, pursuant to which the Company issued and sold 2,788,064 CDIs, each with an accompanying warrant to purchaseone CDI (a “CDI Warrant”), at a price of A$7.50 per CDI and accompanying CDI Warrant (the “CDI Offering,” and together with the Common Stock Offering, the “Private Placement”). The Private Placement generated gross proceeds totaling approximately $25.2 million, which have been received. The Common Stock Offering closed on October 27, 2025 and the CDI Offering closed on November 5, 2025. The Company also issued 250,000 CDI Warrants to the lead manager of the Private Placement.

The issuance and sale of the Shares, Common Stock Warrants, CDIs and CDI Warrants pursuant to the Subscription Agreements and Confirmation Letters were not, and the issuance of the Common Stock Warrant Shares and CDI Warrant Shares will not be, registered under the Securities Act and were and will be issued and sold in reliance on the exemption provided by Section 4(a)(2) of the Securities Act, including under Rule 506 of Regulation D promulgated thereunder, with respect to the Shares, the Common Stock Warrants and the Common Stock Warrant Shares, and Regulation S with respect to the CDIs, CDI Shares, CDI Warrants, and CDI Warrant Shares.

Each of the Common Stock Warrants and the CDI Warrants is exercisable commencing six months after issuance and expires five years from issuance.

The Private Placement closed after the balance sheet date and will be reflected in the next reporting period.

European Regulatory Clearance

Following receipt of the first European regulatory clearance from the Danish Medicines Agency in October 2025, the first patients were enrolled and treated in the PARADIGM Trial.

FDA IDE Approval

In early November 2025, the Company announced U.S. Food and Drug Administration (“FDA”) approval to initiate the PARADIGM Trial, which is designed to evaluate the DurAVR® THV in patients with severe calcific aortic stenosis and to support a future Premarket Approval application submission.

Item 2.