Aspira Women's Health Inc. · OTC:AWHL

Aspira Women's Health — Technical Presentation (October 2024)

47 slides from Aspira Women's Health's technical presentation, Oct 29, 2024

Slide 1: Updates on the Development of Aspira's Ovarian Cancer and Endometriosis Tests
Updates on the Development of the Aspira’s Ovarian Cancer and Endometriosis Tests October 29, 2024
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this presentation are forward-looking statements. These forward- looking statements include, a
Slide 3: Today's Discussion
Today’s Discussion ∞ Welcome & Introductions ∞ ARPA-H Lauchpad Award Summary ∞ Product Development Overview ∞ Our Ovarian Cancer Pipeline ∞ Our Endometriosis Pipeline ∞ Portfolio Market Opportunity ∞ Q&A Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 3
Slide 4: Your Speakers Today
Your Speakers Today Dr. Rick Gersh Aspira Senior Clinical Advisor, Obstetrician Gynecologist Dr. Kevin Elias Lilli and Seth Harris Endowed Chair for Ovarian Cancer at the Cleveland Clinic Dr. Sandra Milligan Aspira President of Clinical and Commercial Operations Copyright (C) Aspira Women's Health I
Slide 5: Aspira Women's Health Investment Highlights
Aspira Women’s Health Investment Highlights Revenue Generating Revenue generating commercial diagnostics company to aid in the detection of ovarian Company cancer and endometriosis Steady Growth Metrics Year-over-year revenue and volume growth since 2020 ARPA-H Award Received $10 million of non-dilu
Slide 8: A Robust, Highly Competitive Process Led to Our Success
A Robust, Highly Competitive Process Led to Our Success • Women’s Health Sprint sought proposals across six categories of women’s health challenges to fund the work that companies/institutions need to accelerate development • 1,700+ submissions, representing 45 states and 34 countries, received from
Slide 12: Cracking the Code: Blood Test Diagnosis of Endometriosis with Multivariate AI Analytics
Cracking the Code: Blood Test Diagnosis of Endometriosis with Multivariate AI Analytics Milestone Funding Based on Progress Milestone Description Amount AWH will receive milestone payments 1 Initial Project Launch $2.0M based on 2 R&D Scale to Meet Operational Needs $1.5M achievement of certain mile
Slide 14: Strategic Focus on Expanding and Evolving our Technology, Capabilities, and Collaborations
Strategic Focus on Expanding and Evolving our Technology, Capabilities, and Collaborations We aspire to radically improve health outcomes for all people born with a female reproductive system through the development and commercialization of advanced gynecologic disease diagnostic solutions Expand cl
Slide 15: The Growth of Aspira's Testing Technologies
0 The Growth of1 Aspira’s Testing Technologies METADATA Patient Features Proprietary Algorithms Proteins PROTEOME Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 15
Slide 16: Reviewer comments on slide 15
Slide 15 0 Update to be accurate. Doesn’t Ova/Overa include patient metadata? Also, delete Endocheck and update the MDX with new tradenames. Dr. Sandra Milligan, 2024-10-19T14:55:52.747 1 Is this “Evolution” or “growth”? The diagram is not depicting any time dynamic, but I don’t have a good alternat
Slide 17: The Growth of Aspira's Testing Technologies
The Growth of Aspira’s Testing Technologies METADATA Patient Features Proprietary Algorithms Proteins miRNA PROTEOME MOLECULAR Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 16
Slide 18: Aspira has the Experience of Complex Diagnostic Development
JS0 Aspira has the Experience of Complex Diagnostic Development Which Demands Robust Scientific Evidence, Reliable Algorithm Performance, and End to End Quality Control Optimize feature selection, Align to platform reduce bias, explore best AI performance, reduce for purpose costs, ease regulatory W
Slide 19: Reviewer comment on slide 17
Slide 17 JS0 Match the template colors Jamie Sullivan, 2024-10-21T13:21:52.506
Slide 22: Indeterminate Masses are a Current Diagnostic Dilemma
Indeterminate Masses are a Current Diagnostic Dilemma Pelvic mass detected on ultrasound1 Probably Benign Uncertain Likely Malignant 18-31% of masses (and more than 50% in some clinical settings) are indeterminate2-4 Watchful waiting Get baseline monitoring management What’s What’s CA 125 and refer
Slide 23: Our Current Comprehensive Portfolio of Ovarian Cancer Blood Tests
Our Current Comprehensive Portfolio of Ovarian Cancer Blood Tests As of October 15th, 2024, OvaWatch is Approved by New York State Department of Health Masses Planned for Non-Surgical Management Masses Planned for Surgery For adnexal masses evaluated by initial clinical For women with pelvic masses
Slide 24: OvaWatch Clinical Usefulness Validated in Large Scale Study of Real Patients
0 OvaWatch Clinical Usefulness Validated in Large Scale Study of Real Patients Clinical Study Design Racially Diverse Retrospective + Multi-Site Prospective Analysis 2,000 Women with adnexal mass as identified on clinical examination and indeterminate or asymptomatic by imaging 1,000 Women from vari
Slide 25: Reviewer comment on slide 22
Slide 22 0 Change title to reflect this is for OW Dr. Sandra Milligan, 2024-10-19T15:27:26.843
Slide 26: Newly Published OvaWatch Study Demonstrating Could Have Reduced Surgeries
Newly Published OvaWatch Study Demonstrating OvaWatch Could Have Reduced Surgeries 0 “Ovarian Cancer Surgical Consideration is Markedly Improved by the Neural Network Powered- MIA3G Multivariate Index Assay,” was published in Frontiers in Medicine in early May 2024 Copyright (C) Aspira Women's Healt
Slide 27: Reviewer comment on slide 23
Slide 23 0 Action Title with OW Dr. Sandra Milligan, 2024-10-19T15:28:19.484
Slide 28: The Potential of Utilizing OvaWatch for Malignancy Risk Assessment and Surgical Triage
The Potential of Utilizing OvaWatch for Malignancy Risk Assessment and Surgical Triage Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 24
Slide 29: Newly Published OvaWatch Study as a Longitudinal Mass Monitoring Test
0 Newly Published OvaWatch Study Demonstrating Use as a Longitudinal Mass Monitoring Test • MIA3G (OvaWatch) was generally unchanged between physician-scheduled clinical visits with respect to the validated cutoff for malignancy risk. • A total of 90% of patients that had a score below the cutoff of
Slide 30: Reviewer comment on slide 25
Slide 25 0 Needs active title Dr. Sandra Milligan, 2024-10-19T15:39:41.258
Slide 32: Aspira's Product Portfolio & In-Development Tests
Aspira’s Product Portfolio & In-Development Tests inform with Longitudinal Monitoring Feature Commercially Commercially Under Development available available for adnexal masses for adnexal masses for indeterminate and prior to surgical planned for surgery likely benign adnexal determination masses 2
Slide 33: Enhanced Assay for Identification of Ovarian Cancer
inform Enhanced Assay for Identification of Ovarian Cancer Aspira’s Advantages OVAinform Assay Features Existing protein-based A promising new AI-powered blood test to aid in the identification of FDA approved test ovarian cancer in women diagnosed with an adnexal mass. Exclusive rights to miRNA • N
Slide 34: OVAinform Development Pathway
inform Development Pathway Planning, Feasibility Verification of Clinical Design Verification of Validation of Clinical Complete Design and Product Performance Software and Analytical Inputs and Outputs Requirements • Identification of • Test independent • Scale up clinical clinical samples miRNA fe
Slide 36: Blood-Based, Non-Invasive Diagnostic Could Lead to Earlier Diagnosis
Blood-Based, Non-Invasive Diagnostic Could Lead to Earlier Diagnosis, Disease Monitoring and Individualized Treatments Delayed Inefficient Symptomatic or Care Barrier Therapeutic Rx Presentation Diagnosis Symptoms overlap Lack of Laparoscopy does Therapies targeted at symptom with other non-invasive
Slide 37: A Non-Invasive Diagnostic Would Decrease the Need for Unreliable Imaging and Invasive Procedures
A Non-Invasive Diagnostic Would Decrease the Need for Unreliable Imaging and Invasive and Expensive Laparoscopic Procedures Opportunity for Aspira Biomarker Clinical History Imaging Assessment Inefficient Triaging Laparoscopy Challenge: Challenge: Challenge: Challenge: Symptom overlap Imaging Often,
Slide 38: Progressing from Protein-based Assay to Multi-omic Assay for Endometriosis
Progressing from Protein-based Assay Strategy to Multi-omic Assay for Diagnosis of Endometriosis Protein Based Assay (EndoCheckSM) Protein + miRNA Based Assay (ENDOinformTM) EndoCheck was designed to aid in the diagnosis ENDOInform is designed to aid in the diagnosis of all endometrioma, one of the
Slide 39: Development Pathway
Development Pathway Planning, Feasibility Verification of Clinical Design Verification of Validation of Clinical Complete Design and Product Performance Software and Analytical Inputs and Outputs Requirements • Test independent • Identification of • Scale up clinical • Design clinical samples miRNA
Slide 40: Our Non-Invasive Diagnostic Will Simplify the Patient Journey
Our Non-Invasive Diagnostic Will Simplify the Patient Journey Current Patient & New Patient & Provider Non-Patient/Provider Provider Journey Journey Stakeholders Include: Pharmaceutical Companies Opportunity for Aspira (companion diagnostics) Delayed Clinical Presentation Payers (less time to diagno
Slide 41: Investment Will Propel Evolution from Prognostic to Theragnostic
Investment Will Propel the Evolution of Our Diagnostic Solution from Prognostic to Theragnostic Collaborate Launch and Post Understanding with Biotech/Pharma Marketing Clinical Study Biomarker Dynamics Partners Longitudinal Diagnostic Prognostic Predictive Experience Longitudinal Experience: Perform
Slide 42: Aspira has Distinct Competitive Advantages
Aspira has Distinct Competitive Advantages, Positioning Our Diagnostics to be Best in Class While other companies are in early proof- of-concept stages, Aspira has: An active partnership with an esteemed An actively enrolling clinical study in the Digital PCR allows for higher resolution in research
Slide 44: Aspira's Commercialization Experience Ensures Quick Market Acceptance
Aspira’s Commercialization Experience Ensures Quick Market Acceptance of New Technologies Competitive There are no non-invasive risk assessment diagnostics available in the U.S. today. Landscape Reimbursement & Aspira has worked closely with national and regional commercial and governmental payers f
Slide 45: >$1B Annual Revenue Potential from Current and Near-Term Products
>$1B Annual Revenue Potential from Current and Near-Term Products Endo Portfolio With Longitudinal inform Monitoring 200-400K patients 1.2-1.5M women 6.5M women in the US affected proceed to surgery 2.0-3.0M potential present with an with endometriosis5 for an adnexal mass tests annually1-4 adnexal
Slide 46: In Summary
In Summary • Our ARPA-H funding provides us fuel to complete development and to commercialize ENDOinformTM a non-invasive diagnostic blood test for women suspected of having endometriosis • Capabilities built to support the development of ENDOinformTM will also support ongoing development of OVAinfo

Aspira Women's Health — Technical Presentation (October 2024) on 6ix

Aspira Women's Health — Technical Presentation (October 2024)

Slide 1: Updates on the Development of Aspira's Ovarian Cancer and Endometriosis Tests

Slide 2: Safe Harbor

Slide 3: Today's Discussion

Slide 4: Your Speakers Today

Slide 5: Aspira Women's Health Investment Highlights

Slide 6: ARPA-H Award Summary

Slide 7: A Historic Investment in Women's Health

Slide 8: A Robust, Highly Competitive Process Led to Our Success

Slide 9: End of template

Slide 10: End of template

Slide 11: End of template

Slide 12: Cracking the Code: Blood Test Diagnosis of Endometriosis with Multivariate AI Analytics

Slide 13: Product Development Overview

Slide 14: Strategic Focus on Expanding and Evolving our Technology, Capabilities, and Collaborations

Slide 15: The Growth of Aspira's Testing Technologies

Slide 16: Reviewer comments on slide 15

Slide 17: The Growth of Aspira's Testing Technologies

Slide 18: Aspira has the Experience of Complex Diagnostic Development

Slide 19: Reviewer comment on slide 17

Slide 20: Our Ovarian Cancer Pipeline

Slide 21: Update on OvaSuite

Slide 22: Indeterminate Masses are a Current Diagnostic Dilemma

Slide 23: Our Current Comprehensive Portfolio of Ovarian Cancer Blood Tests

Slide 24: OvaWatch Clinical Usefulness Validated in Large Scale Study of Real Patients

Slide 25: Reviewer comment on slide 22

Slide 26: Newly Published OvaWatch Study Demonstrating Could Have Reduced Surgeries

Slide 27: Reviewer comment on slide 23

Slide 28: The Potential of Utilizing OvaWatch for Malignancy Risk Assessment and Surgical Triage

Slide 29: Newly Published OvaWatch Study as a Longitudinal Mass Monitoring Test

Slide 30: Reviewer comment on slide 25

Slide 31: Update on OVAinform

Slide 32: Aspira's Product Portfolio & In-Development Tests

Slide 33: Enhanced Assay for Identification of Ovarian Cancer

Slide 34: OVAinform Development Pathway

Slide 35: Our Endometriosis Pipeline

Slide 36: Blood-Based, Non-Invasive Diagnostic Could Lead to Earlier Diagnosis

Slide 37: A Non-Invasive Diagnostic Would Decrease the Need for Unreliable Imaging and Invasive Procedures

Slide 38: Progressing from Protein-based Assay to Multi-omic Assay for Endometriosis

Slide 39: Development Pathway

Slide 40: Our Non-Invasive Diagnostic Will Simplify the Patient Journey

Slide 41: Investment Will Propel Evolution from Prognostic to Theragnostic

Slide 42: Aspira has Distinct Competitive Advantages

Slide 43: Aspira's Market Opportunity

Slide 44: Aspira's Commercialization Experience Ensures Quick Market Acceptance

Slide 45: >$1B Annual Revenue Potential from Current and Near-Term Products

Slide 46: In Summary

Slide 47: Questions? Answers.