CURVEBEAM AI LIMITED — Call Transcript 2024

Apr 29, 2024

QUARTERLY 4C CONFERENCE CALL April 30 2024

DISCLAIM ER

Introduction

THIS DOCUMENT IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES OF AMERICA OR TO ANY RESIDENT THEREOF, OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION IS UNLAWFUL. THIS DOCUMENT IS NOT AN OFFER OR INVITATION TO BUY OR SELL SECURITIES.

This presentation has been prepared by CurveBeam AI Limited (ACN 140 706 618) ( CurveBeam or the Company ) and contains summary information about CurveBeam and the business conducted by it as at 30 April 2024. The information in this presentation is for informational purposes only, does not purport to be complete and is not a prospectus, product disclosure statement or other disclosure document for the purposes of Chapter 6D or Part 7.9 of the Corporations Act 2001 (Cth) ( Act ) or other offer document under Australian law or the law of any other jurisdiction.

The distribution of this document outside of Australia may be restricted by law and any such restrictions should be observed. This document may not be distributed or released to any person in the United States. As further detailed below, none of CurveBeam, nor its advisers ( Advisers ) nor their respective affiliates, related bodies corporate (as defined in the Act) or security holders and their respective directors, officers, employees, partners, representatives, consultants, agents or advisers (each a Limited Party and together, the Limited Parties ) guarantees or make any representation or warranty to, or takes responsibility for, the accuracy, reliability or completeness of the information contained in this presentation, to the recipient of this document (you or the Recipient), and nothing contained in this document is, or may be relied upon as, a promise or representation, whether as to the past or future. To the maximum extent permitted by law, each Limited Party disclaims any liability for any loss arising from the use of information including representations or warranties or in relation to the accuracy or completeness of the information, statements, opinions or matters, express or implied, contained in, arising out of or derived from, or for omissions from, this presentation.

Forward looking statements

The information given in this presentation is given for illustrative purposes only and should not be relied upon as (and is not) an indication of CurveBeam’s views on future performance or condition. Past performance cannot be relied upon as an indicator of future performance. This presentation contains certain forward-looking statements. The words “forecast”, “estimate”, “like”, “anticipate”, “opinion”, “should”, “could”, “may” and other similar expressions are intended to identify future earnings, financial position and performance of CurveBeam. You are cautioned not to place undue reliance on these statements. These forward-looking statements are based on estimates, projections and assumptions made by CurveBeam about circumstances and events that have not yet taken place. Although due care and attention has been used in the preparation of these statements, such forward-looking statements are based on numerous assumptions regarding CurveBeam’s present and future business strategies and the political, regulatory and economic environment in which CurveBeam will operate in the future and are subject to change without notice. Statements about market and industry trends, which are based on interpretations of current market conditions, may not be reasonable, and are not guarantees or predictions of future performance. The actual results or performance of CurveBeam may be materially different from the results or performance expressed or implied by such forward-looking statements. No representation, warranty or assurance (express or implied) is given or made in relation to any forward-looking statement by any person (including any of the Limited Parties). In particular, no representation, warranty or assurance (express or implied is given that the occurrence of the events expressed or implied in any forward-looking statement in this presentation will actually occur). Subject to any continuing obligations under applicable law, the Company expressly disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this presentation to reflect any change in expectations in relation to any forward-looking statement or any change in events, conditions or circumstances on which any statement is based.

Financial information

All numbers in this presentation are stated in Australian dollars ( A$ ) unless stated otherwise.

Not an offer or financial product advice

The information contained in this presentation is for informational purposes only and should not be considered, and does not contain or purport to contain, an offer, invitation, solicitation or recommendation with respect the purchase or sale of any securities in CurveBeam nor does it constitute legal, taxation, financial product or investment advice. The general information in this presentation has been prepared without taking into account the investment objectives, financial situation or particular needs of any particular person. Recipients of the presentation must undertake their own independent investigations, consideration and evaluation. By accepting this presentation, a Recipient agrees that if it proceeds further with its investigations, consideration or evaluation of investing in CurveBeam it will not in any way rely upon this document. Neither this presentation nor any of its contents will form the basis of any contract or commitment and it is not intended to induce or solicit any person to engage in any transaction nor is it intended to be used as the basis for making an investment decision.

CurveBeam recommends that potential investors consult their professional advisors as an investment in CurveBeam is subject to investment and other known and unknown risks, some of which are beyond the control of CurveBeam or its directors and therefore any investment is considered to be speculative in nature.

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2 4C IN V E ST O R PRE SE N T A T IO N

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TM
® ®
3
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4C SUM M ARY OF KEY ACTIVITIES

• During Q3 FY24, CurveBeam AI received purchase orders (POs) for 6 devices for the quarter:

• 3 HiRise[TM] POs from European customers

• 2 LineUP[®] POs in the US

• 1 PedCat[®] PO in the US

• This is a significant increase over the prior corresponding period of 1 HiRise[TM] .

• Q4 FY24 to date , the Company has received POs for a total of 5 devices so far:

• 2 HiRise[TM] POs in the US

• 1 LineUP[®] PO in the US

• 2 PedCat[®] POs in Europe

• Foot & Ankle division of US partner continues to manage the prospects pipeline

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CubeVue Autometrics
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4C SUM M ARY OF KEY ACTIVITIES

• ™

• The Company continues to advance the development of an enhanced HiRise within its targeted timeline and still expects launch in Q1 FY25.

• The timeline for the enhanced HiRise™ remains:

• Q4 FY24: Continued cadaver validation, and orthopaedic surgeon validation of ™

• knee replacement protocols at selected US sites with the enhanced HiRise .

• Q4 FY24/Q1 FY25: Finalisation of validation of hip & knee at sites.

• Q1 FY25: The enhanced HiRise™ will be available for commercial release.

• A study of 500 patients published in March 2024 showed that CurveBeam AI’s CubeVue Autometrics platform for presurgical planning in foot and ankle surgeries was 97% faster than manual methods while being as accurate.

• The first total knee replacement surgery (non-robotic) was planned and successfully completed using scans obtained on the HiRise™ device.

• Targeting FDA clearance in mid-CY25 for the bone mineral density (BMD) software module.

ENHANCED HIRISE™ PROJECT

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• ™

• CurveBeam AI is developing enhancements to the HiRise platform.

• Enables WBCT scans of larger patient hip & knee, to meet key landmarks and specifications required for robotic surgical system planning.

• TM

• [Company expects ][acceptance of HiRise] datasets for knee replacement protocols to be officially in place once enhanced HiRiseTM pilot sites successfully complete robotic TKR planning and subsequent surgery on several patients, anticipated in Q4 FY24 and Q1 FY25.

• The enhanced HiRiseTM is targeted to be filed as a 510(k) special. Existing HiRiseTM clearance already covers obese patients – “The HiRise is intended to be used for 3-D imaging of the upper and the lower extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs .”

• [This is ] [expected to be a straightforward process ][that meets ][our ] timeline. Beyond the mandated 30-day period for clearance, delays can occur if further questions arise or new filing requested. Files (e.g., Electrical Safety) are well advanced.

5 4C IN V E STO R PRE SE N TA TIO N

BM D HIRISE ™ M ODULE PROGRESS

• BMD module is targeting a key annuity stream for sales & profit growth off knee & hip scans.

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HiRise™ a change
agent
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• In the US, there are approx.1.6 million hip and knee total joint replacements, versus approx. 350,000 ankle-related procedures per annum.

• FDA submission for a 510(k) clearance of the BMD module on the enhanced HiRise™ is H2 CY2024.

• Enhanced HiRise™ image needs to set final image specification for BMD determination to complete development of product.

• Predicate device needs to also be run on new enhanced HiRise™ scan.

• Trial enrollment is targeted to be within a month when predicate & CVB’s BMD can be run off the same enhanced HiRise™ scan. (1 site – 200 patients/month).

• ™

• FDA 510(k) clearance for the HiRise BMD targeted for mid CY25.

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IN CLOSING

• HiRise™ placements

  • Enhanced HiRise program progressing on time.

  • Q4 Company expects to have customers using the enhanced HiRise on patients for robotic datasets.

  • Expect that initial placements should demonstrate utility of HiRise™ for custom knee procedures, which will support further growth in the placement of HiRise™ devices / reduce hurdle to closing accounts

• Post knee & hip validation, company remains confident in purchase orders.

• Cash at the end of the Quarter was $11.8m; Q2 4c 2.83 quarters of cash, and Q3 2.63 quarters of cash.

• Company maintains a prudent approach to capital management & is considering further programs to reduce cost base.

The Company’s Directors continue to expect that there will be sufficient cash for two years from the Company’s August 2023 listing, noting though that increasing HiRise™ sales and remaining proactive initiatives in reducing cash outflows will be key factors in achieving this.

Whilst device POs for Q4 FY23 have been promising to date, further growth in HiRise™sales is highly dependent on completion of protocol validation and the commercial release of the enhanced HiRise™ based on the targeted timeline.

CurveBeam AI’s HiRise Weight bearing CT

INVESTM ENT HIGHLIGHTS

First to market

Natural bilateral WBCT & Non WBCT, point of care imaging with targeted proprietary AI solutions

Advanced Regulatory

FDA cleared, TGA & CE marked CT imaging equipment. Targeting regulatory submissions for AI modules

Favourable US Reimbursement in Place

Coding, payment & coverage under existing policies

KOL & Clinical Validation

Key KOL sites as users – Mayo, Duke, HSS 10 years of publications on bone fragility & WBCT

Experienced board & management

with supportive institutional investors - Karst Peak, Tenmile, Firetrail, Acorn, SG Hiscock, Ilwella, Frazis Capital

Building IP position

37 granted patents and 27 pending patents internationally

Large Market Opportunities

Large billion-dollar addressable markets

US partnership established with market leader

Co-marketing & distribution agreement with Stryker Corporation US Foot & Ankle division (NYSE:SYK)

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WEIGHT BEARING CONE BEAM CT FOR TOTAL ALIGNMENT

• ü Quicker and easier to scan than traditional CT and MRI, with faster image acquisition time

ü Radiation dose lower than traditional CT – up to 66% less than traditional CT

ü High resolution and 3D visualisation enables development of new AI based assessment tools

ü

Smaller and lower-cost hardware requiring limited radiation shielding infrastructure

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Hip to Foot in standing 3D

HiRise is the first product capable of WBCT of hip to foot in standing 3D

Weight bearing imaging key to accurate diagnosis WBCT provides unique alignment data required to accurately access bone positioning under standing load

Serves more applications

The HiRise serves various orthopaedic sub-specialties in total knee, hip and ankle replacement planning in addition to implant manufacturers and 3D printed solution providers

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9 4C IN V E ST O R PRE SE N T A T IO N

LAND & EXPAND COM M ERCIALISATION STRATEGY

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• CurveBeam AI utilises a NORTH AMERICA
combination of specialist Operations HQ
5 Sales reps, 2 Marketing EUROPE
distributors and direct salesforce Strategic partners 8 Distributors ASIA
to drive global sales 132 Placements 4 Sales reps 4 Distributors
35 Placements 2 Placements
•
Fast growing sales pipeline to
build on over 170 existing
installations worldwide
SOUTH
• 47 HiRise units placed since FDA AMERICA MENA AUSTRALIA
clearance in late 2020. Circa 75% 2 Distributors 3 Distributors Corporate Office HQSE ASIA Mgt
2 Placements
of placements in the US market 1 Distributor
6 Placements
•
Targeting an installed base of
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• Targeting an installed base of HiRise systems across key global markets including the US and Germany

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10 4C IN V E ST O R PRE SE N T A T IO N

LARGE M ARKET OPPORTUNITY AND ONGOING ADOPTION BY LEADING CUSTOM ERS

CurveBeam AI’s target customer groups	Potential US WBCT Installation Sites1	Potential US Addressable Market2		Select CurveBeam AI customers
Orthopaedic Surgeons & Group			•	Mayo Clinics (all 3 major locations)
Practices Surgeon group practices that have	5,829	A$3.6b	•	NYU Langone Health
imaging capability			•	UCLA Orthopedic Institute for Childre
Imaging Chains Orthopaedic Diagnosis, Surgical planning, fragility fracture diagnosis & management	>6,000	>A$3.7b	• •	Kent State University – College of Po Duke Orthopedics
			•	Midwest Orthopedics at Rush, Chicag
Hospital based
Medium to large hospitals - can incorporate surgical planning for implants, fractures	5,460	A$3.4b	• •	Penn Medicine – Pennsylvania Hospi Hospices Civils De Lyon, France
Integrated Healthcare Networks			•	Massachusetts General Hospital, Bos
(IHN)Imaging departments for
today, new Point of Care			•	Schön Klinik, Munich, Germany
solutions for the future
			•	Hospital for Special Surgery, New Yor
Total	>17,352	>A$10b	•	Ghent University Hospital, Belgium

• UCLA Orthopedic Institute for Children

• Kent State University – College of Podiatric Medicine

• Midwest Orthopedics at Rush, Chicago

• Penn Medicine – Pennsylvania Hospital

• Massachusetts General Hospital, Boston

• Hospital for Special Surgery, New York

• • Ghent University Hospital, Belgium

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1. Source: Frost & Sullivan

2. US HiRise indicative price US$410,000 x $1.50 USD/AUD potential installation sites in the US

11 4C IN V E STO R PRE SE N TA TIO N

INVESTMENT PROPOSITION FOR SURGEONS

Existing reimbursement codes target an attractive financial model for HiRise users

• The average Medicare reimbursement rate for scans of the lower extremity CPT code relevant to the HiRise™, pedCAT™ and LineUP™ was US$138.77 per scan in 2022.

• With an initial capital cost of USD$410,000 and assuming 10 scans per day, the payback period for a HiRise™ (excluding costs) is 1 year and 5 months

• If financed under a lease with an interest rate of 9%, the breakeven number of scans required to pay the machine off over a 5-year term is 2.83 scans per day (excluding costs)

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Atlantic Orthopedic Specialists, Virginia Beach, VA

Actual CurveBeam Customer - PedCat

Device up front cost: $179,000 Volume: 35 scans per month Breakeven: 17 scans/month

Reimbursement range: $99.74 to $294.3[1] Average reimbursement: $242.11 Gross revenue / month: $7014.08

Device payback period of 2.5 years

1. US Payment and coverage varies extensively city to city, state to state and this example represents a specific model for a specific region of the US market

2. 12 4C IN V E ST O R PRE SE N T A T IO N

STRYKER FOOT & ANKLE CO-M ARKETING & DISTRIBUTION US PARTNERSHIP

Stryker is a market leader in orthopaedics with US$18b in sales in FY22.

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STRYKER CORPORATION (NYSE:SYK) BACKGROUND

• [Leading multinational medical technology company - Orthopaedics & ] Spine contributes circa 55% of Stryker’s US$18b sales

• CurveBeam AI Agreement is with Foot & Ankle division at this point

• Stryker have several large product categories in Orthopaedics, including Foot and Ankle and Joint Replacement – hip and knee

• HiRise units will be preloaded with Stryker Prophecy surgical CT planning protocols for surgeon office setting.

• Prophecy preoperative navigation reports and guides are patient-specific tools for total ankle

• Enhanced HiRise targeting robotic system patient-specific tools for hip and knee surgeries

• Targeting through the enhanced HiRise, one WBCT scanner to meet all lower extremity imaging requirements

13 4C IN V E ST O R PRE SE N T A T IO N

BONE HEALTH: CURRENT BONE HEALTH DIAGNOSTIC (DEXA) M ISSES THE M AJORITY OF FRAGILITY FRACTURES

Bone fragility is caused by loss of bone microstructure, BMD measures only bone density & not microstructure

BONE MINERAL DENSITY (BMD): CURRENT STANDARD OF CARE

Commonly administered, limited performance

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DEXA: Dual-energy X-ray is a means of measuring bone mineral density (BMD).

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It basically looks at a silhouette of bone for determining density, as compared to a normal healthy population.

Small changes in bone density can mask major microstructural changes in the cortical and trabecular bones

BONE MICROSTRUCTURE

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Health Control Cortex of a 27yr old
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• 3 electron micrographs – a normal bone density control & female patients of age

• Note - loss of bone microarchitecture is associated with aging

• While loss of bone density

• Cortex of a 70yr old contributes to fragility, the major cause of fragility is loss of microstructure

• • Bone loss may reduce BMD modestly & it can

• Cortex of a 90yr old mask major microstructural changes

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14 4C IN V E ST O R PRE SE N T A T IO N

BM D AND OSSVIEW OVERVIEW

CurveBeam AI’s proprietary SaaS solutions leverage CT scans generated from its HiRise device

HiRise a change

agent

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BONE MINERAL DENSITY

• [AI driven BMD report utilising CurveBeam AI’s high ] resolution CT scans for BMD (hip) & bone microstructure (ankle) assessment. Possible only on the HiRise

• [Under development - target FDA 510(k) filing in H2 ] CY2024

• [On FDA clearance, the company expects to be able to ] provide BMD reports in conjunction with imaging for total joint replacements, with a goal to improve surgery planning, to prevent revision surgery

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Healthy Bone Patient’s Bone
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OssView (SFS)

• [AI generated report for aiding physicians in the assess] z ~~[ment of fracture risk ]~~ with non-osteoporotic BMD

• [OssView awarded ] [FDA Breakthrough Device Designation. ] Ossview (wrist) with HR-pQCT under review by FDA (targeting clearance in FY24)

• [Also, to be enabled by HiRise (feature under development)]

• [BMD CT has a f] avourable reimbursement in place in the US market

15 4C IN V E ST O R PRE SE N T A T IO N

AI M ODULES ALSO TARGET VALUE ADD SUBSCRIPTIONS ON HIRISE INSTALL BASE

CubeVue AutoMetrics aims to reduce 16 hours of CT dataset preparation prior to pre-surgical planning to a scan available in 15 minutes

"To minimize future

predicted costs, morbidity, & mortality from increasing numbers of fragility fractures in our rapidly aging population, the AAOS recommends that bone fragility should become a national public health priority"

- American Association of Orthopedic Surgeons (AAOS)

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THE PROBLEM

Aids in bone segmentation for accurately identifying key anatomical points

• Orthopaedic pre-treatment planning involves understanding of the structure and alignment of the foot – 26 bones & 33 joints

• To segment the bones in the foot and accurately assess bone geometry & alignment requires ~6 hours of manual effort. Not feasible in practice

• Typically, surgeons will make crude manual measurements on 2D radiographs

• No reimbursement in place at this point

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THE SOLUTION

CurveBeam AI DLAI segmentation-as-a-service model

• Working 3D model with measurements in minutes for surgeons

• WBCT images drive improvements in accuracy & consistency

• CBAI has several key patents awarded in DLAI & nonAI for bone segmentation

• Targeting this IP for a platform solution for other CT modalities, in addition to WBCT (B2B)

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16 4C IN V E ST O R PRE SE N T A T IO N

INVESTM ENT SUM M ARY CurveBeam AI produces and sells market leading weight bearing CT scanners. The Company has established key recognised clinical customers and a leading vendor partner.

Regulatory	First to market, FDA cleared, TGA and CE Marked Point of Care Weight Bearing and high resolution Cone
Clearances	Beam CT imaging equipment
Significant addressable market	Large A$10b plus A$4.1b per annum addressable markets
Commercial stage	Commercial stage company with revenue for FY2023 of $11.5m AUD
Favourable Reimbursement	Favourable reimbursement for CT scans (US/Germany) and BMD HiRise targeted annuity (US only)
Tier 1 Partnership	Distribution partnership with the foot and ankle division of Stryker (NYSE:SYK) to aid in driving growth
Established global footprint	170+ Device placements worldwide including top tier institutions for upgrading
High margin AI solutions	Enhanced HiRise to underpin incremental high margin AI module revenues commencing mid CY2025

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17 4C IN V E ST O R PRE SE N T A T IO N