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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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(Address of Principal Executive Offices)
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(Zip Code)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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Item 2.02. |
Results of Operations and Financial Condition.
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Item 9.01. |
Financial Statements and Exhibits.
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Exhibit
No.
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Description
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ASX Quarterly Results Announcement
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ASX Announcement regarding financial results for the quarter ended March 31, 2025
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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Anteris Technologies Global Corp.
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Date: May 13, 2025
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By:
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/s/ Wayne Paterson
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Name:
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Wayne Paterson
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Title:
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Vice Chairman and Chief Executive Officer
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Name of entity:
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Anteris Technologies Global Corp. (“ATGC”)
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ARBN:
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677 960 235
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Reporting period:
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For the quarter ended March 31, 2025
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US$20.8 million for the ongoing development of DurAVR® THV and the preparation and enrolment of the Pivotal Trial of DurAVR® THV for treating severe aortic stenosis; and
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Investor Relations | Investor Relations (US) |
investors@anteristech.com | mchatterjee@bplifescience.com |
Debbie Ormsby | Malini Chatterjee, Ph.D. |
Anteris Technologies Global Corp. | Blueprint Life Science Group |
+61 1300 550 310 | +61 7 3152 3200 | +1 917 330 4269 |
Website | www.anteristech.com |
X | @AnterisTech |
https://www.linkedin.com/company/anteristech |
• |
Investigational Device Exemption (“IDE”) for the DurAVR® THV’s global, pivotal clinical trial (the “PARADIGM Trial”), submitted to the FDA during the First Quarter
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Scale up for commencement of the PARADIGM Trial ongoing – including expanding the Clinical Specialist Team and contracting with planned centers in the U.S., Canada and Europe
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Clinical milestone of 100 patients successfully treated with the DurAVR® THV – comprised of de novo aortic stenosis cases including complex anatomies, and valve-in-valve patients
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Reported one-year clinical data for DurAVR® THV – demonstrating sustained, favourable hemodynamic outcomes, a consistent safety profile and high implant success
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Ongoing expansion of global manufacturing capacity to scale for the PARADIGM Trial and meet initial anticipated commercial demand
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Anteris included in the FTSE Russell 2000® Index
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Concluded the First Quarter with a cash position of $49.0m (A$78.0m)
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860 Blue Gentian Road, Suite 340
Eagan, MN, 55121 United States
T: +1 651 493 0606
info.us@anteristech.com
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Anteris Technologies Global Corp.
BRISBANE | MINNEAPOLIS | GENEVA | MALAGA
![]() anteristech.com
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Toowong Tower, Level 3, Suite 302
9 Sherwood Road, Toowong
QLD 4066, Australia T: +61 1300 550 310
info.au@anteristech.com ARBN: 677 960 235 |
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Favorable hemodynamics sustained to one-year: DurAVR® THV demonstrated an Effective Orifice Area (EOA) of 2.1 + 0.2 cm2, a Mean Pressure Gradient (MPG) of 8.6 + 2.6 mmHg and Doppler Velocity Index (DVI) of 0.58.
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Strong safety profile at one year: No valve or cardiovascular related mortality. Importantly, there was no prosthesis-patient mismatch (PPM) reported in small annuli patients with aortic annulus area of 395.80 + 37.26 mm2, while current commercial devices have rates between 11.2% to 35.3% PPM1, a predictor of valve failure and disease progression.
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R&D expenses during the three months ended March 31, 2025 were $16.5 million, an increase of $4.9 million (42%) compared to $11.6 million for the same period in the prior year. This is
primarily due to $3.5 million relating to the upscaling of manufacturing capabilities including process design and validation activities and the expansion of headcount and $1.5 million relating to preparatory activities linked to the
PARADIGM Trial, including clinical costs associated with the enrollment of additional patients;
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Selling, general and administrative expenses during the three months ended March 31, 2025 were $5.7 million, a decrease of $0.8 million (13%) compared to $6.5 million for the same period in the
prior year, primarily due to a reduction of $1.2 million relating to costs incurred in the first quarter of 2024 associated with the plans to re-domicile, list on Nasdaq and conduct our initial public offering, partly offset by a $0.8
million increase in legal, tax and compliance costs linked to dual listing requirements and other operational matters. There was also a decline in share based payment expense of $0.5 million.
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Investor Relations
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Investor Relations (US)
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investors@anteristech.com
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mchatterjee@bplifescience.com
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Debbie Ormsby
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Malini Chatterjee, Ph.D.
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Anteris Technologies Global Corp.
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Blueprint Life Science Group
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+61 1300 550 310 | +61 7 3152 3200
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+1 917 330 4269
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Website
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www.anteristech.com
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X
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@AnterisTech
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LinkedIn
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https://www.linkedin.com/company/anteristech
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