Anteris Technologies Global Corp.

Anteris Technologies Global Corp. announced it has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) for its DurAVR® Transcatheter Heart Valve (THV) global pivotal trial, known as the PARADIGM Trial. This authorization allows patient recruitment to begin in France, a strategically important market. The PARADIGM Trial is a randomized controlled study comparing DurAVR® THV to existing TAVRs in approximately 1,000 patients with severe calcific aortic stenosis, assessing non-inferiority on a composite endpoint at one year.

Anteris Technologies Global Corp. has entered into a Sales Agreement with TD Securities (USA) LLC to establish an "at the market" offering program. Under this agreement, the company may offer and sell up to $250,000,000 of its common stock from time to time. TD Cowen will act as the sales agent, receiving a commission of 3.0% of the gross proceeds from sales. The net proceeds from this offering are primarily designated for the ongoing development of the DurAVR® Transcatheter Heart Valve System, with the remainder allocated to working capital and general corporate purposes.

Anteris Technologies Global Corp. announced the appointment of Ms. Susan Knight and Mr. Stephen Denaro to its Board of Directors, effective May 11, 2026. Ms. Knight, a former Board Chair of Surmodics, Inc. and CFO of MTS Systems Corporation, will serve as a Class I Director and join the Audit and Risk Committee. Mr. Denaro rejoins the Board as a Class II Director. Both non-employee directors will receive annual cash retainers and equity grants, with Ms. Knight receiving an initial RSU grant valued at $250,000.

Anteris Technologies Global Corp. reported Q1 2026 financial results, including net operating cash outflows of $28.7 million, primarily due to clinical, regulatory, and manufacturing requirements for the PARADIGM Trial. The company successfully completed aggregate capital raises totaling $320 million in January 2026 to support the trial and advance toward global commercialization of the DurAVR THV System. Significant progress was made in the PARADIGM Trial, with patient enrollment ongoing in Europe and commencing in the U.S. post-quarter end, supported by CMS coverage determination.

Anteris Technologies Global Corp. reported a net loss of $(23.0) million for Q1 2026, an increase from $(21.9) million in Q1 2025, primarily due to higher R&D and SG&A expenses. Net sales decreased slightly to $0.49 million. The company significantly bolstered its financial position through a public offering and a private placement with Medtronic, raising approximately $320.0 million in gross proceeds, leading to a cash balance of $283.2 million as of March 31, 2026.

Anteris Technologies Global Corp. announced the successful enrollment and treatment of the first U.S. patients in its DurAVR® Transcatheter Heart Valve (THV) global pivotal trial, known as the PARADIGM Trial. These procedures, performed at Montefiore Medical Center in New York, mark a significant milestone for the company, expanding recruitment capabilities for the trial. The PARADIGM Trial is a prospective randomized controlled study designed to evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements in approximately 1000 patients.

Anteris Technologies Global Corp. (AVR), through its subsidiary, notified v2vmedtech, inc. (v2v) of its decision to discontinue additional development contributions under their April 18, 2023 agreement. This termination, occurring during Stage 2 of the program, requires AVR to pay a $400,000 break fee to v2v. As a result, AVR has no further development obligations, and v2v's initial shareholders can either acquire AVR's equity interest in v2v or reduce AVR's ownership. AVR does not anticipate a material adverse effect on its financial position or liquidity.

Anteris Technologies Global Corp. (AVR) announced it has secured U.S. Medicare reimbursement eligibility for its global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy. This coverage, under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32, operates via a Coverage with Evidence Development (CED) model. This milestone is expected to accelerate U.S. site activation and operational momentum for the trial, which will evaluate the DurAVR Transcatheter Heart Valve against commercially available TAVRs.

Anteris Technologies Global Corp., through its subsidiary, has entered into a lease agreement for a substantial 181,436 square foot office and warehouse facility in Brooklyn Park, Minnesota. The lease commences on September 1, 2026, with an initial term of 11 years and options for two 7-year extensions. This strategic move signifies a significant expansion of the company's operational footprint, supported by initial rent abatements.