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Anteris Technologies Global Corp. Capital/Financing Update 2024

Jul 23, 2024

33869_rns_2024-07-23_8910d174-b6e1-4a65-bdd1-40d90fdb5113.pdf

Capital/Financing Update

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ASX ANNOUNCEMENT

24 July 2024

Anteris Raises $30 Million

Brisbane, Australia and Minneapolis, USA

Anteris Technologies Ltd (ASX: AVR) ( Anteris or the Company ) is pleased to announce that it has successfully completed a $30.0 million single tranche placement (" Placement ") of new fully paid ordinary shares in Anteris (" New Shares ") at $16.00 per New Share, which has been supported by new and existing institutional and sophisticated investors. The funds raised will be used for:

  • ongoing development of DurAVR[®] THV;

  • preparatory activities for the DurAVR[®] THV pivotal registration study and additional firstin-human studies;

  • upscaling in-house manufacturing;

  • continued v2vmedtech research and development; and

  • general working capital.

The new shares will be issued from the Company’s available placement capacity under Listing Rule 7.1.

The Company continues to progress towards achieving FDA approval for the DurAVR[®] global Phase 3 pivotal study. Positive biomimetic outcomes continue to provide confidence that the trial is on track to enrol quickly. Anteris is now positively positioned to commence the FDA submission, conduct ongoing pre-market commercialisation activities and stay abreast of discussions with potential partners.

Placement Summary

The Placement will involve the issue of approximately 1.875 million New Shares at an issue price of $16.00 per New Share to raise $30.0 million (before costs). The issue is pursuant to the Company’s available placement capacity under ASX Listing Rule 7.1.

The issue price of $16.00 for the New Shares represents, as at 19 July 2024, a discount of 6.2% to the last closing price of $17.05 per New Share.

Placement Timetable

Placement Timetable
Event Date
Trading halt and launch of Placement 22 July 2024
Announcement of completion of Placement and Trading Halt lifted 24 July 2024
Settlement of New Shares issued under the Placement 29 July 2024
Allotment, quotation and trading of New Shares issued under the Placement 30 July 2024

Canaccord Genuity and Evolution Capital acted as Joint Lead Managers to the Placement. Bell Potter Securities Limited acted as Co-Manager to the placement.

A copy of the investor update presentation is attached.

ENDS

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REGISTERED OFFICE Toowong Tower, Level 3, Suite 302 9 Sherwood Road Toowong, QLD 4066 Australia

T: +61 1300 550 310 [email protected] anteristech.com

BRISBANE | MINNEAPOLIS | GENEVA | MALAGA

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About Anteris Technologies Ltd (ASX: AVR)

Anteris Technologies Ltd (ASX: AVR) is a structural heart company committed to designing, developing, and commercialising innovative medical devices. Founded in Australia, with a significant presence in Minneapolis, USA (a MedTech hub), Anteris is science-driven, with an experienced team of multidisciplinary professionals delivering transformative solutions to structural heart disease patients.

The Company’s lead product, DurAVR[®] , is a transcatheter heart valve (THV) for treating aortic stenosis. DurAVR[®] THV was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons. It is the first transcatheter aortic valve replacement (TAVR) to use a single piece of bioengineered tissue. This biomimetic valve is uniquely shaped to mimic the performance of a healthy human aortic valve.

DurAVR[®] THV is made using ADAPT[®] tissue, Anteris’ patented anti-calcification tissue technology. ADAPT[®] tissue has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide.

The ComASUR[®] Delivery System was designed to provide controlled deployment and accurate placement of the DurAVR[®] THV with balloon-expandable delivery, allowing precise alignment with the heart’s native commissures to achieve optimal valve positioning.

Anteris Technologies is set to revolutionise the structural heart market by delivering clinically superior solutions for significant unmet clinical needs.

Authorisation and Additional information

This announcement was authorised by the Board of Directors.

All dollar values are in Australian dollars unless otherwise stated.

For more information:

Investor Relations

[email protected] Anteris Technologies Ltd +61 1300 550 310 | +61 7 3152 3200

Investor Relations (US)

Malini Chatterjee, Ph.D., Managing Director Blueprint Life Science Group +1 917 330 4269

Website www.anteristech.com Twitter @AnterisTech Facebook www.facebook.com/AnterisTechnologies LinkedIn https://www.linkedin.com/company/anteristech

Not an offer in the United States

This announcement has been prepared for publication in Australia and may not be released to US wire services or distributed in the United States. This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or any other jurisdiction. Any securities described in this announcement have not been, and will not be, registered under the US Securities Act of 1933 and may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the US Securities Act and applicable US state securities laws.

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Not for release to US wire services or distribution in the United States

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Equity Raise Presentation Anteris Technologies Ltd (ASX: AVR)

July 2024

1

A N T E R I S T E C H . C O M

Disclaimer

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Summary information

This presentation has been prepared by Anteris Technologies Ltd (the “Company”). It is a presentation of general background information in summary form about the Company’s activities current at the date of this presentation. The information does not purport to be complete, comprehensive or to comprise all the information which a potential investor may require in order to determine whether to deal in the Company's securities, nor does it contain all the information which would be required in a disclosure document prepared in accordance with the Corporations Act 2001 (Cth) (the “Corporations Act”). It is to be read in conjunction with the Company’s other announcements released to the Australian Securities Exchange (“ASX”) (available at www.asx.com.au).

No offer, advice or recommendation

This presentation is for information purposes only and should not be read or understood as an offer, invitation, solicitation, inducement or recommendation to subscribe, buy or sell securities in the Company in any jurisdiction. This presentation will not form any part of any contract or commitment for the acquisition of the Company's securities. This presentation is not a prospectus or other offering document under Australian law or any law. It will not be lodged with the Australian Securities and Investments Commission (“ASIC”).

Nothing contained in this presentation constitutes financial product, investment, legal, tax or other advice. It does not take into account the investment objectives, financial situation or needs of any particular investor. You should consider the appropriateness of the information in this presentation having regard to your own investment objectives, financial situation and needs and with your own professional advice, when deciding if an investment is appropriate.

This presentation may not be distributed or released to US wire services in the United States. This presentation and the information contained herein does not constitute an offer to sell, or the solicitation of an offer to buy, any securities in the United States or in any other jurisdiction in which such offer would be illegal. Any securities described in this presentation have not been, and will not be, registered under the U.S. Securities Act of 1933 (the “Securities Act") or the securities laws of any state or other jurisdiction of the United States, and may not be offered or sold, directly or indirectly, in the United States unless the securities have been registered under the Securities Act (which the Company has no obligation to do or to procure) or are offered or sold pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable securities laws of any state or other jurisdiction of the United States.

The release, publication or distribution of this presentation in certain jurisdictions may be restricted by law and therefore persons in such jurisdictions into which this presentation is released, published or distributed should inform themselves about and observe such restrictions.

Forward-looking statements

This presentation contains forward looking statements Forward-looking statements can generally be identified by use of words such as “may”, “should”, “could”, “foresee”, “plan”, “aim”, “will”, “expect”, “intend”, “project”, “estimate”, “anticipate”, “believe”, “forecast”, "target", "outlook", "guidance" or “continue” or similar expressions. Forward looking statements include statements about the future financial or operating performance of the Company and its related bodies corporate, statements about the Company’s current and future clinical studies, statements about the obtention and timing of regulatory approvals for the Company's products under development, statements about the Company's plans, strategies and objectives, including regarding the commercialisation of its products, and statements about the industry and the markets in which the Company operates and statement about the effect of the offer described herein and proposed use of proceeds. Such statements represent the Company’s current views with respect to future events and are necessarily based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant technical, business, economic, competitive, political and social risks, contingencies and uncertainties.

These forward-looking statements are based on assumptions and contingencies that are subject to change without notice and involve known and unknown risks, uncertainties and other factors, many of which are beyond the control of the Company and its related bodies corporate and affiliates (and each of their respective directors, securityholders, officers, employees, partners, agents, advisers and management), and could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements or any projections and assumptions on which those statements are based.

Disclaimer cont.

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Forward-looking statements are provided as a general guide only and should not be relied on as an indication or guarantee of future performance.

There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims - - any intent or obligation to update any forward looking statements, whether as a result of new information, future events or results or otherwise. All forward looking statements made in this presentation are - qualified by the foregoing cautionary statements. Investors are cautioned that forward looking statements are not predictions or guarantees of future performance, and accordingly investors are cautioned not to - put undue reliance on forward looking statements due to the inherent uncertainty therein. The Company does not undertake to update any forward-looking information, except in accordance with applicable securities laws.

Financial data

All currency amounts are in Australian Dollars ("$") unless otherwise stated.

Investors should be aware that financial data in this presentation include "non-IFRS financial information" under ASIC Regulatory Guide 230 "Disclosing non-IFRS financial information" published by ASIC and also "non-GAAP financial measures" within the meaning of Regulation G under the U.S. Securities Exchange Act of 1934, and are not recognised under Australian Accounting Standards (“AAS”) and International Financial Reporting Standards (“IFRS”). The disclosure of non-GAAP financial measures in the manner included in this presentation may not be permissible in a registration statement under the Securities Act. The non-IFRS financial information/non-GAAP financial measures in this presentation may not have a standardised meaning prescribed by AAS or IFRS and may therefore not be comparable to similarly titled measures presented by other entities and should not be construed as an alternative to other financial measures determined in accordance with AAS or IFRS.

Although the Company believes this non-IFRS financial information/non-GAAP financial measures provides useful information to users in measuring the financial performance and condition of the Company, investors are cautioned not to place undue reliance on any non-IFRS financial information/non-GAAP financial measures included in this presentation.

The financial information in this presentation is presented in an abbreviated form insofar as it does not include all the disclosures required by the AAS and other mandatory professional reporting requirements applicable to general purpose financial reports prepared in accordance with the Corporations Act.

A number of figures, amounts, percentages estimates, calculations of value and other fractions used in this presentation are subject to the effect of rounding.

Past performance

Past performance is given for illustrative purposes only. It should not be relied on and is not indicative of future performance, including future security prices.

Market data

Certain market and industry data used in this presentation may have been obtained from research, surveys or studies conducted by third parties, including industry or general publications. Neither the Company nor its representatives or its advisers have independently verified any market data (“Market Data”) or industry data provided by third parties or industry or general publications.

Market Data is provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. The Market Data may assume the success of the Company’s business strategies, the success of which may not be realised within the period for which the Market Data has been prepared, or at all.

No guarantee, representation or warranty, express or implied, is made as to the accuracy, likelihood or achievement or reasonableness of any Market Data. Except as required by applicable laws, rules or regulations, none of the Issuer, its representatives or advisers intends to, or undertakes to, or assumes any obligation to, provide any additional information or revise the Market Data, whether as a result of a change in expectations or assumptions, new information, future events, results or circumstances.

CORPORATE SUMMARY

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Anteris has taken a targeted approach to solving a critical unmet need

We have created the first new class of transcatheter aortic valve replacement (TAVR) in over a decade: DurAVR[TM] THV

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As of 23 May 2024, Source Market Index

A$328m Market Capitalisation: (as of 19 July 24) Shares on issue: 19.2m L1 Capital: 16.9% Top Shareholders: Perceptive: 11.1% (as of 30 June 2024) Sio Capital: 5.4% Board Shares & 2.34m Options (all): Minneapolis, Perth, Offices: Brisbane, Geneva Employees: 133 Cash (as of 30 June 2024): A$10.1m

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Overview Company

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THE OPPORTUNITY
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TAVR is a US$10bn+ Market Opportunity

Underpenetrated patient population with only 15-20% of severe aortic stenosis cases treated today

TAVR Aortic Stenosis + Valve-in-Valve market value[1]

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$13.5
14
Current range of
estimates:
12 3.5
10% - 35% of the
2.9
TAVR market
2.3
10
$8.1 1.7
1.2
8 0.7
6
9.6 10
9.1
8.6
8.1
4 7.4
2
0
2023 2024 2025 2026 2027 2028
Aortic Stenosis (TAVR) Valve-in-Valve (ViV)
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Potential for further significant growth

Currently 3 trials in progress, slated to be completed in 2025

Edwards Lifesciences : the largest randomised trial to date assessing the role of early intervention among patients with asymptomatic severe AS

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Edwards Lifesciences : will examine the TAVR procedure in patients who are > 65 years, have moderate AS, and have at least one additional risk factor

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Medtronic : to explore the treatment of moderate (AS) with early TAV implantation (TAVI) before AS becomes severe

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AORTIC STENOSIS (AS)

A life-threatening heart condition which occurs when there is a narrowing of the aortic valve

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Treatment Options

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SAVR

Surgical Aortic Valve Replacement

TAVR

Transcatheter Aortic Valve Replacement

This narrowing restricts blood flow from the heart to the body’s main artery, the aorta, and subsequently to the rest of the body. Patients with severe AS have a 50% risk of dying within 2 years.[1]

non-surgical, minimally invasive

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  1. Leon MB, Smith CR, Mack M, et al. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. N Engl J Med. 2010;363(17):1597-1607. doi:10.1056/NEJMoa1008232

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DESIGN TARGET
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Anteris set out to address the needs in TAVR by asking different questions

How does a healthy aortic valve perform?

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How can we mimic a native valve?

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How can we put that valve in a frame?

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How do we deliver the valve?

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Our expert panel of physicians determined what is needed in a next generation valve:

  • § What will future, younger TAVR patients need?

  • § What are the compromises faced with TAVR?

  • § What is missing from current valve platforms?

  • § What is the easiest way to deliver the valve?

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64 55k Patients treated with Patients treated with DurAVR[TM] ADAPT[®] tissue

As of July 2024

As of July 2024 (sold as CardioCel[®] , VascuCel[®] )

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UNMET CLINICAL NEED
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Yesterday’s TAVRs were not developed for today’s patients

Patients need a safe alternative to open heart surgery

First & second generation TAVRs

~85 yrs

2011-2013 average patient age was 84[1]

Patients need a valve that restores an active lifestyle for the rest of their life

Third generation TAVRs ~65 yrs

2016-2017 average patient age is 73 & declining[2]

DurAVR was deliberately designed for younger and more active patients

DurAVR[TM] THV: A New Class of TAVR

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Single-piece, native-shaped biomimetic design built to mimic the performance of a healthy aortic valve.

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DurAVR [TM]
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Proprietary innovation that leads to a more ‘Human Like’ valve

'A balloon expandable valve with self-expanding hemodynamics is like the Holy Grail[1] .'

Dr Michael Reardon, Professor of Cardiothoracic Surgery

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Opens wider (45%), restoring predisease hemodynamics

Designed to be anatomically correct, to restore normal laminar flow[2]

Single piece design provides greater structural integrity and durability

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Balloon Expandable Advantages

  • Short frame height

  • • Ease of use

  • • Predictability

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Self Expandable Advantages

  • Optimal hemodynamics

  • • Commissure alignment

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Three highly innovative technologies = clinical and commercial advantage

Anteris has addressed unmet medical needs with a new class of products for the treatment of aortic stenosis. This new class of biomimetic technology can be used for new patients, ( USD 10 BN ) and replace existing valves in patients ( USD 3BN ) (valve-in-valve (“ViV”)).

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  • FDA approved tissue since 2014

  • Novel biomimetic valve

    • Balloon expandable platform
  • Shaped to perform like a native aortic valve

  • Distributed for use in over 55,000 patients globally (as a cardiac and vascular patch)

    • Provides controlled deployment and accurate alignment of the DurAVR[TM] THV valve with the position of the native aortic valve
  • Single piece of tissue

  • Clinically proven to be calcium free for up to 10 years[1]

  • Improved coronary access

    • Patent for the sterilised packaging system
  • US patent protected design (11,648,107 and 11,622,853)

1. Neethling W, Rea A, Forster G, Bhirangi K. Performance of the ADAPT-Treated CardioCel[®] Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes. Front Pediatr. 2020 Apr 24;8:198. doi: 10.3389/fped.2020.00198. PMID: 32391296; PMCID: PMC7193326.

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CLINICAL RESULTS: FIRST-IN-HUMAN (FIH)

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DurAVR[TM] - Consistent Hemodynamic Results through 1 Year

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Post-procedure Hemodynamic Results
(N=41)
Mean Annulus Size: 22.57 mm
EOA 2.20
(Effective Orifice
Area)
cm [2]
No moderate or MPG
8.5
severe PVL (Mean Pressure
Gradient) mmHg
DVI
(Doppler Velocity 0.62
Index)
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Sustained Hemodynamics Through 1 Year

Mean Annulus Size: 22.73 mm

Cavalcante J. Biomimetic Design Restores Flow and Hemodynamics and Leads to Significant LV Mass Regression: update from First-in-Human (FIH) Study with novel DurAVR[TM] Transcatheter Heart Valve. Oral Presentation at: New York Valves; June 2024; New York, New York. *One subject died of a non-cardiac death before reaching 1-year follow-up.

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CLINICAL RESULTS: EFS
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DurAVR[TM] US Early Feasibility Study

Paradigm shifting 30-day hemodynamic (blood flow) results Excellent safety profile, no paravalvular leak at 30-day follow up*

Effective Orifice Area (EOA)

  • The cross–sectional area of the aortic valve opening that is available for blood flow

  • Patients with severe AS have an EOA of ≤ 1cm[2]

Mean Pressure Gradient (MPG)

  • The average pressure across the aortic valve between the left ventricle and aorta

  • Patients with severe AS have MPG ≥ 40 mmHg

  • *Follow-up Echo Core Lab Analysis

Meduri C. DurAVR[TM] Biomimetic Transcatheter Heart Valve: Early Feasibility and First-in-Human Trial Update. Oral Presentation at: EuroPCR Conference; May 2024; Paris, France.

*Subject had pre-existing significant conduction abnormalities with prolonged QRS .

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SUPERIOR HEMODYNAMICS
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Comparative data: DurAVR[TM] EFS data vs. market leader

+38% +37% +45% EOA Improvement MPG Improvement DVI Improvement Effective Orifice Area Mean Pressure Gradient Doppler Velocity Index (EOA) cm[2] (MPG) mmHg (DVI) 2.18 7.5 0.64 Market leader* 1.58 11.94 0.44

DurAVR[TM] IN ACTION

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In addition to traditional endpoints, DurAVR[TM] is the first aortic valve to restore normal aortic flow

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Normal Flow- Impaired Aortic Flow--
Severe AS Sapien 3
Healthy
FD = 10%
Aortic
FRR = 1%
Valve
(n=5)
FD = 46% FRR = 23% FD = 48% FRR = 35%
Evolut R CEP Magna Ease
Post
FD = 14%
DurAVR™
FRR = 4%
THV
(n=5)
FD = 25% FRR = 4% FD = 27% FRR = 30%
Normal Valve vs DurAVR ™ : No significant difference in flow (p>0.05) Normal Valve flow vs: TAVR p<0.05 SAVR p<0.01
FD = Flow Displacement | FRR = Flow Reversal Ratio
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Courtesy of Dr. Pankaj Garg, Norwich University Hospital (UK)

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LAMINAR FLOW

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Biomimetic Design Leads to Restoration of Laminar Flow Aortic Flow Displacement (%) Aortic Flow Reversal Ratio (%)

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48
46
27
25
15
10
N=5
N=5 N=11
Healthy DurAVR ™ Severe AS Edwards Medtronic CEP Magna
Aortic Valve THV Sapien 3 Evolut R Ease
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35
30
23
N=11
5
4
1
Healthy DurAVR ™ Severe AS Edwards Medtronic CEP Magna
Aortic Valve THV Sapien 3 Evolut R Ease
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Courtesy of Dr. Pankaj Garg, Norwich University Hospital (UK)

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DurAVR [TM] PIVOTAL STUDY (PHASE 3)
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The First All Risk Head-to-Head TAVR Registration Trial

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DurAVR [TM] PIVOTAL STUDY (PHASE 3)
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Biomimetic outcomes are driving enthusiasm, the trial is expected to enroll quickly

Anteris will request continued access for DurAVR[TM] with the FDA

ENROLLMENT

Patients are screened for eligibility. If selected, they are randomized and treated.

FOLLOW UP

Patients return monthly for 12 months, then complete their 1 year follow up (primary study endpoint). Follow up then continues annually for 10 years.

REVIEW

Company assembles the data into a submission package and sends to the FDA. The FDA reviews and grants market approval.

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Category B Revenue $25k per device

Continued Access Revenue $25k per device

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MANUFACTURING
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ADAPT[® ] tissue engineering (AU), DurAVR[TM] assembly (US)

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  • ADAPT[® ] : multi-step, anti-calcification, tissue engineering process

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  • Transforms animal tissue into a durable bio-scaffold (mimics human tissue and mitigates structural valve deterioration)

  • Single-piece of shaped ADAPT[®] tissue attached to a stent via sutures

  • Valve sterilized and packaged for use

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Next Steps

  • FDA approval for global pivotal trial (US, EU, AU, ~80 sites)

  • Pivotal trial patient recruitment commences

  • FDA submission commences (modular approach)

  • Monthly discussions with FDA

  • Ongoing pre-market commercialisation activities

  • Ongoing discussions with potential partners

  • Pivotal trial completion (incl. 1-year follow up)

  • FDA submission complete

  • FDA approval and commercialization

Investment Summary

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ATTRACTIVE SIGNIFICANT MARKET SUPERIOR CLINICAL EXCELLENT SAFETY PATENTS IN PLACE INVESTMENT OPPORTUNITY RESULTS TO DATE RECORD PROPOSITION

  • › Current TAVR market US$7.4bn and forecast to grow to US$10bn by 2028 plus valve-invalve (ViV) opportunity

  • › Patient population expanding; low risk, younger patients

  • › TAVR/Surgical now >50% TAVR

  • › >30% clinical

  • superiority vs market leader (comparative data)

  • › Hemodynamic results comparable to healthy valve

  • › >60 patients have received DurAVR[TM]

  • › ADAPT[®] Tissue distributed to >55k patients globally

  • › Excellent safety profile

  • › No valve related deaths

  • › No disabling stroke

  • › No myocardial infarctions

  • › No life-threatening bleeding

  • › Robust IP portfolio encompassing DurAVR[TM] , ADAPT[®]

  • tissue technology and ComASUR[TM] delivery system

  • › Strong team and advisory board

  • › DurAVR[TM] is the first new class of valve in 20 years

  • › Positive feedback from key opinion leaders and medical fraternity to date

  • › Product heavily de-risked

  • › Mkt cap US$233m vs EW $53bn

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Leadership Team

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BOARD OF DIRECTORS
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  • Anteris Chair since 2017 and director since October 2014

  • • Chair of Preceptis Medical Inc since 2016 and Phraxis Medical Inc since 2009

  • Executive VP at Cedar Point Capital, a broker-dealer focused on healthcare investment from 2015 until Dec 2023

  • Chair of Synovis Inc., from 2008-2012, a NASDAQ-listed manufacturer of medical device and bio scaffold tissue products (acquired by Baxter)

  • Co-Founder, Chair and CEO of NeoChord Inc., from 2007 until 2014

  • • Various executive level positions, including Director of Marketing for Cardiac Rhythm Management, VP of Sales for Cardiac Surgery and VP of Sales for Cardiac Rhythm Management at Guidant Corp. (subsequently acquired by Boston Scientific) from 1996 to 2006

  • Co-Founder, President and CEO of ACIST Medical, from 1991 to 1995

• Bachelor of Arts Speech Communications, University of Minnesota and MBA, Carlson School of Management, University of Minnesota

John Seaberg Chairman

  • Director since October 2018, Anteris Company Secretary since 2018

  • • Provision of company secretarial services to other ASX-listed companies since 1994, and director and sole shareholder of Trio Business Intermediaries Pty Ltd, a business consulting company, specialising in restructuring, corporate governance, directorship and company secretarial

  • Over 25 years of experience in M&As, business valuations, accountancy services, and income tax compliance gained from positions as Company Secretary and CFO of various public companies and major chartered accountancy firms in Australia and the United Kingdom

  • Bachelor of Business in Accountancy, Graduate Diploma in Applied Corporate Governance and member of the Institute of Chartered Accountants in Australia & New Zealand, and the Australian Institute of Company Directors

Stephen Denaro Non-Executive Director Company Secretary

Wayne Paterson Managing Director & CEO

Dr. Wenyi Gu Non-Executive Director

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  • Joined Anteris in October 2014 as a Non-Executive Director, served as Chair from February 2016 to March 2017, Interim CEO from May 2016, and CEO and Managing Director since March 2017

  • Chair of v2vmedtech, inc. from March 2023

  • Non-Executive Director Cepheid (Molecular Diagnostics)(NASDAQ:CHPD) 2014 to 2016

  • Senior positions at Merck KGaA (“Merck”) from 2005 to 2013, including President of Europe, Canada and Australia, President of Emerging Markets, President of Japan and President of Cardiovascular Medicine

Senior positions at Roche Pharmaceuticals from 1995 to 2005, including Head of Pharmaceuticals in Roche’s South Korean operation and Head of Commercial Operations for Roche China MBA from the University of Southern Queensland and a degree in Business Studies from the Queensland University of Technology

  • Director since October 2018

  • Guest professor with several Chinese institutes and universities

  • Research Fellow for the Australian Institute for Bioengineering and Nanotechnology at the University of Queensland since Jan 2017

  • Chief Scientific Officer of Guangzhou Gillion Biotherapeutics Ltd, a biotechnology company from April 2021 to March 2023

  • Master’s degree in veterinary science and PhD in biochemistry and molecular biology, Australian National University, later worked at John Curtin Medical School

Held a Peter Doherty Fellowship (2006-2009) and was supported by the National Health and Medical Research Council to work at Harvard Medical School, Harvard University as a visiting fellow

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EXECUTIVE LEADERSHIP TEAM
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  • Joined Anteris in October 2014 as a Non-Executive Director, served as Chair from February 2016 to March 2017, Interim CEO from May 2016, and CEO and Managing Director since March 2017

  • Chair of v2vmedtech, inc. from March 2023

  • Non-Executive Director Cepheid (Molecular Diagnostics) (NASDAQ:CHPD) 2014 to 2016

  • Senior positions at Merck KGaA (“Merck”) from 2005 to 2013, including President of Europe, Canada and Australia, President of Emerging Markets, President of Japan and President of Cardiovascular Medicine

  • Senior positions at Roche Pharmaceuticals from 1995 to 2005, including Head of Pharmaceuticals in Roche’s South Korean operation and Head of Commercial Operations for Roche China

  • MBA from the University of Southern Queensland and a degree in Business Studies from the Queensland University of Technology

Wayne Paterson Managing Director & CEO

  • Chief Financial Officer since November 2018

  • Chief Financial Officer of v2vmedtech, inc. from March 2023

  • 29 years of experience in Finance

  • Previous experience at KPMG across Australia and the US, covering the financial services, transport, industrial markets, health, childcare and energy industries

  • Director of the State Library of Queensland where he was the Chair of the Audit and Risk Management Committee for 8 years

  • Bachelor of Economics from Macquarie University, Associate of Chartered Accountants in Australia and New Zealand, a Fellow of the Financial Services Institute of Australasia and a Member of the Australian Institute of Company Directors

Matthew McDonnell Chief Financial Officer

David St. Denis Chief Operating Officer

Dr. Chris Meduri Chief Medical Officer

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  • Chief Operating Officer since July 2017

  • Chief Executive Officer of v2vmedtech, inc. since 2023

  • Head of Commercial Operations for Europe and Canada at Merck from 2013 to 2017

  • Head of Operations for Emerging Markets at Merck since 2008 to 2013

  • Strategic consulting services from 2006 to 2008

  • Multiple leadership roles at Millennium Pharmaceuticals, Inc, now Takeda Pharmaceutical Company, from 1996 to 2006

  • Bachelor of Science, the University of Connecticut, a Master of Arts from Boston University and an MBA in Global Management and International Marketing from Babson College – Franklin W. Olin Graduate School of Business

  • Chief Medical Officer since 2021 after serving on the advisory board since 2016

  • Practicing Interventional Cardiologist at Karolinska University Hospital, Stockholm, Sweden and recognized global leader in the field of valvular heart disease with over 3,500 career structural heart procedures and over 300 annually

  • Served as global head of numerous TAVR, mitral and tricuspid trials. Has participated in 16 early feasibility studies and performed numerous first-in-human, first-in-US and first-in-Europe procedures

  • Completed his general, interventional and structural heart disease training at Beth Israel Deaconess Medical Center, Harvard Medical School

  • Masters in Public Health (MPH) with a focus on Clinical Effectiveness at the Harvard School of Public Health. He completed his internship and residency in Internal Medicine at Duke University

MEDICAL ADVISORY BOARD

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Anteris is guided by a global team of well regarded cardiovascular Physician advisors

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United States

Europe

Australia

27

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Equity Raising Summary

EQUITY RAISING SUMMARY

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  • § Anteris is undertaking an Institutional Placement to raise A$30m via the issue of ~1.9 million new fully paid ordinary shares (“ New Shares ”) at $16.000 per

  • Offer Size and Structure share (“ Offer Price ”) (“ Placement ” or “ Offer ”). Anteris reserves the right to take oversubscriptions of up to ~A$10 million.

  • § The New Shares issued under the Placement will rank pari passu with existing fully paid shares on issue.

Offer Price

  • § Fixed Placement price of A$16.000 per New Share, which as at 19 July 2024, represents a discount of: o 6.2% to the last closing price of A$17.050 per New Share

  • Placement proceeds will be used to fund:

  • Ongoing development of DurAVR[TM] THV;

Use of Proceeds

  - The preparation of the FDA pivotal trial of DurAVR[TM] THV;

  - `o` Upscaling In-house Manufacturing;

  - Continued v2vmedtech R&D; and

  - `o` General working capital.
  • See slide 30 for further details.

  • § Canaccord Genuity and Evolution Capital are acting as Joint Lead Managers to the Placement.

  • Broker Syndicate § Bell Potter Securities Limited have been appointed as Co-Manager to the Placement.

29

SOURCES AND USE OF FUNDS

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R&D on Ongoing Development of DurAVR[TM] THV

  • Advancement of the delivery system and expandable sheath, chronic animal studies, valve sizing and simulation

Upscaling In-house Manufacturing

  • Preparation for commercial production including design validation activities, valve manufacture and quality control processes

Clinical Trial Program

  • On-going preparatory activities for the DurAVR[TM] pivotal registration study (IDE submission, site selection etc.), additional First-in-Human studies

v2vmedtech Research and Development

  • Continued R&D activities

Corporate

  • Continued investment in corporate functions to support the company’s growth

Other

  • NASDAQ preparatory work, marketing activities and legacy contractual agreements with LeMaitre and 4C
Sources of Funds
A$m
%
Sources of Funds
A$m
%
Sources of Funds
A$m
%
Sources of Funds
A$m
%
Sources of Funds
A$m
%
Existing cash (as at 30 June 2024)
Placement proceeds
10.1
30.0
25%
75%
Total sources
40.1
100%
Uses of Funds
A$m
%
R&D on Ongoing development of DurAVRTM THV
20.0
50%
Upscaling in-house manufacturing
6.0
15%
Clinical Trial Program
4.0
10%
Continued v2vmedtech R&D
2.0
5%
General working capital and costs of the offer 8.1 20%
Total uses
40.1
100%

30

EQUITY RAISING TIMETABLE

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Event
Date
Event
Date
Trading halt and launch of Placement 22 July 2024
Announcement of completion of Placement and trading halt lifted 24 July 2024
Settlement of New Shares issued under the Placement 29 July 2024
Allotment, quotation and trading of New Shares issued under the Placement 30 July 2024

31

The Placement timetable is indicative only and subject to variation. The Company reserves the right to alter the timetable at its discretion and without notice, subject to ASX Listing Rules and the Corporations Act.

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Appendix I International Offer Jurisdictions

Appendix I - International Selling Jurisdictions

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This document does not constitute an offer of new ordinary shares (“New Shares”) of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may not be offered or sold, in any country outside Australia except to the extent permitted below.

Canada (British Columbia, Ontario and Quebec provinces)

This document constitutes an offering of New Shares only in the Provinces of British Columbia, Ontario and Quebec (the “Provinces”), only to persons to whom New Shares may be lawfully distributed in the Provinces, and only by persons permitted to sell such securities. This document is not a prospectus, an advertisement or a public offering of securities in the Provinces. This document may only be distributed in the Provinces to persons who are “accredited investors” within the meaning of National Instrument 45-106 – Prospectus Exemptions , of the Canadian Securities Administrators.

No securities commission or authority in the Provinces has reviewed or in any way passed upon this document, the merits of the New Shares or the offering of the New Shares and any representation to the contrary is an offence.

No prospectus has been, or will be, filed in the Provinces with respect to the offering of New Shares or the resale of such securities. Any person in the Provinces lawfully participating in the offer will not receive the information, legal rights or protections that would be afforded had a prospectus been filed and receipted by the securities regulator in the applicable Province. Furthermore, any resale of the New Shares in the Provinces must be made in accordance with applicable Canadian securities laws. While such resale restrictions generally do not apply to a first trade in a security of a foreign, non-Canadian reporting issuer that is made through an exchange or market outside Canada, Canadian purchasers should seek legal advice prior to any resale of the New Shares.

The Company as well as its directors and officers may be located outside Canada and, as a result, it may not be possible for purchasers to effect service of process within Canada upon the Company or its directors or officers. All or a substantial portion of the assets of the Company and such persons may be located outside Canada and, as a result, it may not be possible to satisfy a judgment against the Company or such persons in Canada or to enforce a judgment obtained in Canadian courts against the Company or such persons outside Canada.

Any financial information contained in this document has been prepared in accordance with Australian Accounting Standards and also comply with International Financial Reporting Standards and interpretations issued by the International Accounting Standards Board. Unless stated otherwise, all dollar amounts contained in this document are in Australian dollars.

Statutory rights of action for damages and rescission. Securities legislation in certain Provinces may provide a purchaser with remedies for rescission or damages if an offering memorandum contains a misrepresentation, provided the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s Province. A purchaser may refer to any applicable provision of the securities legislation of the purchaser’s Province for particulars of these rights or consult with a legal adviser.

Certain Canadian income tax considerations. Prospective purchasers of the New Shares should consult their own tax adviser with respect to any taxes payable in connection with the acquisition, holding or disposition of the New Shares as there are Canadian tax implications for investors in the Provinces.

Language of documents in Canada. Upon receipt of this document, each investor in Canada hereby confirms that it has expressly requested that all documents evidencing or relating in any way to the sale of the New Shares (including for greater certainty any purchase confirmation or any notice) be drawn up in the English language only. Par la réception de ce document, chaque investisseur canadien confirme par les présentes qu’il a expressément exigé que tous les documents faisant foi ou se rapportant de quelque manière que ce soit à la vente des valeurs mobilières décrites aux présentes (incluant, pour plus de certitude, toute confirmation d’achat ou tout avis) soient rédigés en anglais seulement.

European Union (excluding Austria)

This document has not been, and will not be, registered with or approved by any securities regulator in the European Union. Accordingly, this document may not be made available, nor may the New Shares be offered for sale, in the European Union except in circumstances that do not require a prospectus under Article 1(4) of Regulation (EU) 2017/1129 of the European Parliament and the Council of the European Union (the “Prospectus Regulation”). In accordance with Article 1(4)(a) of the Prospectus Regulation, an offer of New Shares in the European Union is limited to persons who are “qualified investors” (as defined in Article 2(e) of the Prospectus Regulation).

Appendix I - International Selling Jurisdictions

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Hong Kong

WARNING: This document has not been, and will not be, registered as a prospectus under the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32) of Hong Kong, nor has it been authorised by the Securities and Futures Commission in Hong Kong pursuant to the Securities and Futures Ordinance (Cap. 571) of the Laws of Hong Kong (the “SFO”). Accordingly, this document may not be distributed, and the New Shares may not be offered or sold, in Hong Kong other than to “professional investors” (as defined in the SFO and any rules made under that ordinance).

No advertisement, invitation or document relating to the New Shares has been or will be issued, or has been or will be in the possession of any person for the purpose of issue, in Hong Kong or elsewhere that is directed at, or the contents of which are likely to be accessed or read by, the public of Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to New Shares that are or are intended to be disposed of only to persons outside Hong Kong or only to professional investors. No person allotted New Shares may sell, or offer to sell, such securities in circumstances that amount to an offer to the public in Hong Kong within six months following the date of issue of such securities.

The contents of this document have not been reviewed by any Hong Kong regulatory authority. You are advised to exercise caution in relation to the offer. If you are in doubt about any contents of this document, you should obtain independent professional advice.

New Zealand

This document has not been registered, filed with or approved by any New Zealand regulatory authority under the Financial Markets Conduct Act 2013 (the “FMC Act”).

  • The New Shares are not being offered or sold in New Zealand (or allotted with a view to being offered for sale in New Zealand) other than to a person who:

  • is an investment business within the meaning of clause 37 of Schedule 1 of the FMC Act;

  • meets the investment activity criteria specified in clause 38 of Schedule 1 of the FMC Act;

  • is large within the meaning of clause 39 of Schedule 1 of the FMC Act;

  • is a government agency within the meaning of clause 40 of Schedule 1 of the FMC Act; or

  • is an eligible investor within the meaning of clause 41 of Schedule 1 of the FMC Act.

Singapore

This document and any other materials relating to the New Shares have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore. Accordingly, this document and any other document or materials in connection with the offer or sale, or invitation for subscription or purchase, of New Shares, may not be issued, circulated or distributed, nor may the New Shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore except pursuant to and in accordance with exemptions in Subdivision (4) Division 1, Part 13 of the Securities and Futures Act 2001 of Singapore (the “SFA”) or another exemption under the SFA.

This document has been given to you on the basis that you are an “institutional investor” or an “accredited investor” (as such terms are defined in the SFA). If you are not such an investor, please return this document immediately. You may not forward or circulate this document to any other person in Singapore.

Any offer is not made to you with a view to the New Shares being subsequently offered for sale to any other party in Singapore. On-sale restrictions in Singapore may be applicable to investors who acquire New Shares. As such, investors are advised to acquaint themselves with the SFA provisions relating to resale restrictions in Singapore and comply accordingly.

Appendix I - International Selling Jurisdictions

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United Kingdom

Neither this document nor any other document relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Markets Act 2000, as amended (“FSMA”)) has been published or is intended to be published in respect of the New Shares.

The New Shares may not be offered or sold in the United Kingdom by means of this document or any other document, except in circumstances that do not require the publication of a prospectus under section 86(1) of the FSMA. This document is issued on a confidential basis in the United Kingdom to “qualified investors” within the meaning of Article 2(e) of the UK Prospectus Regulation. This document may not be distributed or reproduced, in whole or in part, nor may its contents be disclosed by recipients, to any other person in the United Kingdom.

Any invitation or inducement to engage in investment activity (within the meaning of section 21 of the FSMA) received in connection with the issue or sale of the New Shares has only been communicated or caused to be communicated and will only be communicated or caused to be communicated in the United Kingdom in circumstances in which section 21(1) of the FSMA does not apply to the Company.

In the United Kingdom, this document is being distributed only to, and is directed at, persons (i) who have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005 (“FPO”), (ii) who fall within the categories of persons referred to in Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the FPO or (iii) to whom it may otherwise be lawfully communicated (“relevant persons”). The investment to which this document relates is available only to relevant persons. Any person who is not a relevant person should not act or rely on this document.

United States

This document does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States. The New Shares have not been, and will not be, registered under the US Securities Act of 1933 or the securities laws of any state or other jurisdiction of the United States. Accordingly, the New Shares may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the US

Securities Act and applicable US state securities laws.

The New Shares may be offered and sold in the United States only to:

  • institutional accredited investors within the meaning of Rule 501(a)(1), (2), (3), (7), (8), (9) and (12) under the US Securities Act; and

  • dealers or other professional fiduciaries organized or incorporated in the United States that are acting for a discretionary or similar account (other than an estate or trust) held for the benefit or account of persons that are not US persons and for which they exercise investment discretion, within the meaning of Rule 902(k)(2)(i) of Regulation S under the US Securities Act.

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Appendix II Key Risks to the Offer

Appendix II – Key Risks

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Our business and any investment in our securities involves risks. If any of these risks actually occur, our business, financial condition and results of operations would likely be materially adversely affected. In such case, the trading price of our securities would likely decline, and you may lose all or part of your investment. Set forth below is a summary of some, but not all, of the principal risks we face:

  • We have a history of operating losses and may not achieve or maintain profitability in the future.

  • There is substantial doubt about our ability to continue as a going concern.

  • Even if this offering is successful, we will require substantial additional future financing and may be unable to raise sufficient capital, which could have a material impact on our research and development programs or commercialization of our products.

  • Unsuccessful clinical trials or procedures relating to our products could have a material adverse effect on our prospects.

  • If we are unable to successfully identify, develop, obtain and maintain regulatory clearance or approval and ultimately commercialize any of our current or future products, or experience significant delays in doing so, our business may be harmed.

  • Even if a product receives regulatory clearance or approval, it may still face development and regulatory difficulties that could delay or impair future sales of products.

  • Some of our products are in development and may not achieve market acceptance, which could limit our growth and adversely affect our business, financial condition, and results of operations.

  • We may find it difficult to enrol patients in our clinical trials, and patients could discontinue their participation in clinical trials, which could delay or prevent clinical trials and make those trials more expensive to undertake.

  • We operate in a highly competitive and rapidly changing industry, and if we do not compete effectively, our business will be harmed.

  • The success of many of our products depends upon certain key physicians and heart valve centres.

  • We rely on third parties to conduct our clinical trials and preclinical studies. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, our development programs and our ability to seek or obtain regulatory clearance and approval for or commercialize our products may be delayed.

  • We are subject to various risks relating to international activities that could affect our profitability, including risks associated with currency fluctuations and changes in foreign currency exchange rates.

  • Any failure to protect our information technology infrastructure and our products against cyber- based attacks, network security breaches, service interruptions or data corruption could materially disrupt our operations and harm our business.

  • Increased emphasis on environmental, social, and governance matters may have an adverse effect on our business, financial condition, results of operations and reputation

Appendix II – Key Risks

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  • We could become exposed to product liability claims that could harm our business, and we may be unable to obtain insurance coverage at acceptable costs and adequate levels.

  • Use of our products in unapproved circumstances could expose us to liabilities.

  • Our products and operations are subject to extensive government regulation, including environmental, health and safety regulations, which could result in substantial costs. Further, any failure to comply with applicable requirements could harm our business.

  • Healthcare policy changes may have a material adverse effect on us.

  • Tax laws, regulations, and enforcement practices are evolving and may have a material adverse effect on our results of operations, cash flows and financial position.

  • Our success depends on our ability to protect our intellectual property and our proprietary technology.

  • Intellectual property rights of third parties could adversely affect our ability to commercialize our products.

  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.

  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

  • Any difficulty with protecting our intellectual property could diminish the value of our intellectual property rights in the relevant jurisdiction.

  • Anteris continues to evaluate a potential dual listing of its (or a successor entity’s) securities on NASDAQ and ASX and undertaken some preparatory work related to this. This potential dual listing may result in significant costs including additional ongoing compliance costs. Any potential dual listing would be subject to customary conditions, which may include market and other conditions, obtaining any necessary shareholder and/or court approval and obtaining any necessary approvals from regulatory authorities (in the United States and Australia). There can be no assurance Anteris will complete a potential dual listing in a timely manner or at all.

  • The market price and trading volume of our shares may be volatile and may be affected by economic conditions beyond our control.

  • An active trading market for our shares may not develop and you may not be able to resell your shares at or above your acquisition price, if at all.

  • We have identified material weaknesses in our internal control over financial reporting. If we fail to remediate these material weaknesses, or if we experience additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our shares.