Aspira Women's Health Inc. · OTC:AWHL
Aspira Women's Health — Investor Day (October 2024)
42 slides from Aspira Women's Health's investor day 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 Launchpad 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 6: ARPA-H Award Summary
ARPA-H Award Summary Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 6
Slide 7: A Historic Investment in Women's Health
A Historic Investment in Women’s Health Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 7
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 9: End of template
End of template Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 9
Slide 10: End of template
End of template Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 10
Slide 11: End of template
End of template Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 11
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 13: Product Development Overview
Product Development Overview Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 13
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
The Growth of 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: 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 17: Aspira has the Experience of Complex Diagnostic Development
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 World
Slide 18: Our Ovarian Cancer Pipeline
Our Ovarian Cancer Pipeline Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 18
Slide 19: Update on OvaWatch
Update on Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 19
Slide 20: 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 21: 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 22: OvaWatch Clinical Usefulness Validated in Large Scale Study of Real Patients
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 varied
Slide 23: Newly Published OvaWatch Study Demonstrating OvaWatch Could Have Reduced Surgeries
Newly Published OvaWatch Study Demonstrating OvaWatch Could Have Reduced Surgeries “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 Health
Slide 24: 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 25: Newly Published OvaWatch Study Demonstrating Use as a Longitudinal Mass Monitoring Test
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 5
Slide 26: Update on OVAinform
Update on inform Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 26
Slide 27: 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 28: 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 29: 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 30: Our Endometriosis Pipeline
Our Endometriosis Pipeline Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 30
Slide 31: Blood-Based, Non-Invasive Diagnostic Could Lead to Earlier Diagnosis, Disease Monitoring and Individualized Treatments
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 32: 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 33: Progressing from Protein-based Assay Strategy to Multi-omic Assay for Diagnosis of 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 34: 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 miRNA and • Design sample runs •
Slide 35: 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 36: Investment Will Propel the Evolution of Our Diagnostic Solution 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 37: Aspira has Distinct Competitive Advantages, Positioning Our Diagnostics to be Best in Class
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 38: Aspira's Market Opportunity
Aspira’s Market Opportunity Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 38
Slide 39: Aspira's Commercialization Experience Ensures Quick Market Acceptance of New Technologies
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 40: >$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 41: 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 ENDOinform TM will also support ongoing development of OVAinf
Slide 42: Questions? Answers.
Questions? Answers. Copyright (C) Aspira Women's Health Inc., 2024. All Rights Reserved. 42