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Exhibit 99.1

Results Announcement

Name of entity:	Anteris Technologies Global Corp.
ARBN:	677 960 235
Reporting period:	For the year ended December 31, 2024

The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) and are denominated in U.S. dollars.

The Company’s results for announcement to the market are as follows:

Refer to the attached “Anteris Reports 2024 Financial Results and Provides Corporate Update”.

Net tangible assets is calculated as net assets (including Right-of-Use assets) less intangible assets.  The net tangible asset backing per share was $1.74 and $1.04 as of December 31, 2024 and December 31, 2023, respectively.

No dividends were proposed, declared, or issued during the year ended December 31, 2024.

The consolidated annual financial statements on which this report is based have been audited by KPMG. The Independent Auditor’s opinion is not modified but includes an Emphasis of Matter that the Company has suffered losses from operations that raise substantial doubt about its ability to continue as a going concern.

Anteris Technologies Global Corp. (“ATGC”) was incorporated in Delaware on January 29, 2024. ATGC was formed for the purpose of reorganizing the operations of Anteris Technologies Ltd (“ATL”), an Australian public company originally registered in Western Australia, Australia and listed on the ASX, into a structure whereby the ultimate parent company would be a Delaware corporation.  On December 16, 2024, ATGC  received all the issued and outstanding shares of ATL pursuant to a scheme of arrangement under Australian law between ATL and its shareholders under Part 5.1 of the Corporations Act 2001 (Cth). In accordance with ASC 805 Business Combinations, when ATGC acquired ATL, the transaction was accounted for as a reverse recapitalization.  The substance of the transaction was that the pre-transaction shareholders of ATL (the accounting acquirer) had effectively obtained control of ATGC. Under reverse recapitalization accounting, the consolidated financial statements are issued under the name of the legal parent (being ATGC) but, with the exception of stockholder’s equity, the financial statements represent a continuation of ATL’s  financial information.

On April 18, 2023, the Group acquired 30% of the shares of v2vmedtech, inc. Since acquisition date, the entity has been treated as a controlled entity for accounting purposes.  There have been no changes in the holding percentage since acquisition date.

On December 13, 2024 ATGC released a prospectus for an initial public offering of 14,800,000 shares of Common Stock to be sold at an initial public offering price of $6.00 per share. The prospectus included detail of the intended use of the net proceeds being:

There were no material variances in the use of funds during the fourth quarter of 2024.  The convertible notes totalling $5.7 million were repaid on December 19, 2024, and the facility was terminated in February 2025.

During the fourth quarter of 2024, the aggregate amount of payments for director fees, ATL Company secretarial fees and Chief Executive Officer remuneration was $374 thousand.

None.

Additional 4E disclosure requirements and commentary on these results are contained in the Form 10-K Annual Report for the year ended December 31, 2024.

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2024 Full Year Highlights & Recent Developments

 

 

 

 

 

 

 

 

“This has been a transformational year for Anteris as we made advancements across all aspects of our business, which positions us well to commence the Pivotal Trial of our DurAVR^® THV system in 2025,”  said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.

 

Business & Operations

 

DurAVR^® THV Commercialisation Update:

 

Preparations for Pivotal Trial

 

During 2024, the Company executed several key activities to facilitate obtaining approval from the FDA to commence a Pivotal Trial for the Company’s lead product, the DurAVR^® THV system. The approval to commence the Pivotal Trial, if granted, requires submitting an IDE application to the FDA, which is planned for the first quarter of 2025. Multiple pre-submission meetings with the FDA occurred covering topics such as reviewing the Pivotal Trial’s clinical plan and statistical rationale. Other key preparatory activities included life cycle testing, test method creation and validation, human factors validation testing with physicians, sterilization and shipping validation, and simulated use testing.

 

Expanded clinical experience

 

During 2024, Anteris advanced preparations for the DurAVR^® THV’s planned EU-EFS. The first two cases were performed in January 2025 at Structural Heart Copenhagen in Denmark by Dr Ole De Backer.  Excellent outcomes were achieved in a native aortic valve stenosis and a degenerated surgical valve. The EU-EFS is planned to be carried out in Denmark, Sweden, the Netherlands, France and Germany, enrolling up to 40 patients, to provide both Valve-in-Valve (“ViV”) data in a controlled setting as well as generate further feasibility and safety data in patients with severe aortic stenosis. The objective of these EU-EFS implants is to build awareness, understanding and experience with the DurAVR^® THV system.

 

Clinical data presented at major medical conferences

 

Over the course of 2024, the Company attended several key industry conferences to promote awareness among clinicians of the DurAVR^® THV system as a potential new treatment paradigm for aortic stenosis. These activities included podium presentations at Cardiovascular Research Technologies or CRT (March 2024), Sydney Valves (March 2024), Society for Cardiovascular Angiography & Interventions or SCAI (May 2024), Euro PCR (May 2024), New York Valves (June 2024), the 36^th Annual Transcatheter Cardiovascular Therapeutics or TCT Conference (October 2024) and London Valves (Nov 2024).

 

Data presented during the year included US-EFS 30-day results, First-in-Human (“FIH”) 1-year results demonstrating sustained hemodynamic performance, ViV data and a post-transcatheter aortic valve replacement (“TAVR”) cardiac magnetic resonance (“CMR”) imaging study demonstrating restoration of laminar flow and early left ventricular reverse remodelling following treatment with the DurAVR^® THV.

 

Scaled up manufacturing to support Pivotal Trial

 

During 2024, the Company’s team continued design optimizations to the DurAVR^® THV system to optimise the procedure, support ease of use and lower manufacturing costs.  Additionally, manufacturing scale-up progressed at both the Malaga, AU and Minneapolis, US manufacturing facilities as well as outsourced suppliers of the key components and delivery system. Additionally, Anteris engaged a Contract Research Organisation and bolstered in-house resources to support planned requirements to initiate and manage the Pivotal Trial.

 

About the DurAVR^® THV Pivotal Trial

 

This prospective Pivotal Trial is anticipated to be the first all-risk, head-to-head TAVR registration trial to date. The Pivotal Trial is expected to include up to 80 sites across the U.S. and other key markets with an estimated 1,000 to 1,200 patients having severe, calcific aortic stenosis, and subject to customary study exclusions. The Pivotal Trial will be on a 1:1 randomised basis with patients receiving either the DurAVR^® THV or TAVR using a commercially available and approved THV from the SAPIEN series (Edwards Life Sciences) or the Evolut series (Medtronic). This is intended to generate the widest possible patient population from the Pivotal Trial, enabling direct comparison with existing therapy and support a claim to the FDA of non-inferiority of the DurAVR^® THV. Patients with a failed surgical bio-prosthesis needing ViV TAVR will be enrolled in a separate parallel registry. This is intended to support the Company’s plans for the ViV market opportunity. To date, 86 patients have been implanted with the DurAVR^® THV with an expanding dataset over one year and overall promising performance across several haemodynamic measures.

 

2024 Financial Results

 

The financial results for Anteris for the year ended December 31, 2024 compared to December 31, 2023 are reviewed below.   All amounts in $ refer to US dollars.

 

 

 

In 2024, Net Sales were $2.7 million relating to sales of our tissue product. In line with contractual arrangements, the manufacture of products for LeMaitre ceased in January 2025.

 

In 2024, the Net Loss after Income Tax of $76.0 million, was driven by operating expenses principally related to research and development to support the planned launch of the Pivotal Trial in 2025 and increased selling, general and administrative expenses which includes the re-domiciliation, Nasdaq listing and the US IPO.

 

Anteris refers to the detailed Financial Information contained in its Form 10-K filing including the Management Discussion & Analysis and the Risks.

 

Corporate and Financing Activities

 

In October 2024, Anteris entered an AUD $25.0 million secured convertible note facility (the “Bridging Facility”) with Obsidian Global Partners, LLC (“Obsidian”) to provide funding, primarily for the period prior to the US IPO. In total AUD $7.5 million was drawn down under the Bridging Facility. The Bridging Facility was subsequently terminated in February 2025.

 

In December 2024, Anteris completed its US IPO, through the offering of 14,800,000 shares of common stock (the “Common Stock”) in the U.S. at a price of $6.00 per share (the “Offering”) raising $79.6 million after costs and commissions. Anteris Common Stock were then listed on the Nasdaq Global Market from 13 December 2024 and on 17 December 2024, Anteris listed its CHESS Depositary Interests (CDIs) on a 1 CDI-for-1 share of Common Stock basis, on the ASX.

 

In January 2025, TD Cowen, Barclays and Cantor (the “IPO Underwriters”) partially exercised the underwriters’ option to purchase additional shares granted by Anteris in respect of 78,481 shares of Common Stock at the purchase price of $6.00 per share, less underwriting discounts and commissions, to raise a further $0.4 million.

 

About Anteris

 

Anteris^® Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.

 

Anteris’ lead product, the DurAVR^® Transcatheter Heart Valve (“THV”), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR^® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow.  DurAVR^® THV is made using a single piece of molded ADAPT^® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT^® tissue, which is FDA-cleared, has been used clinically for over 10  years and distributed for use in over 55,000 patients worldwide.  The DurAVR^® THV system is comprised of the DurAVR^® valve, the ADAPT^® tissue, and the balloon-expandable ComASUR^® delivery system.

 

Forward-Looking Statements

 

This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ registration statement filed on December 10, 2024 with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.

Authorisation and Additional information

This announcement was authorised for release on the ASX by the Board of Directors.

 

For more information:

 

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