Multi-Modal BioInformatics Solution for Ovarian Cancer - NASDAQ: AWH l January 2021
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Multi-Modal BioInformatics
Solution for Ovarian Cancer
NASDAQ: AWH l January 2021
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, among others, statements about Aspira Women’s Health Inc.’s (the “Company”) products, pricing, addressable market, potential product expansion and anticipated timing of product launches. The Company’s actual results may differ materially from the views expressed in these forward-looking statements. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify such forward-looking statements. The events and circumstances reflected in the Company’s forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Readers are cautioned that these forward-looking statements speak only as of the date of this presentation, and the Company does not assume any obligation to update, amend or clarify them to reflect events, new information or circumstances after such date except as required by law. Company estimates set forth in this presentation are based on various sources of information and various assumptions and judgments made by the Company, which Company management believes are reasonable. However, the Company cannot assure you that Company estimates are correct, and actual data may materially differ from Company estimates. The forward-looking statements reflect the views of the Company as of the date of this presentation and are subject to certain risks, uncertainties and assumptions, including the risks and uncertainties inherent in the Company’s business and including those described in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, as supplemented by the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2020. This presentation is © copyright 2021 by Aspira Women’s Health Inc. All Rights Reserved. 2 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
TABLE OF CONTENTS Our Mission..................................................................................................................................... SLIDE 5 Introduction to Patient Life Cyle and and Market.................................................................... SLIDE 9 Starting with Ovarian Cancer..................................................................................................... SLIDE 16 A Growing Total Addressable Market...................................................................................... SLIDE 26 Financials and Market Access.................................................................................................. SLIDE 33 Wrap Up and Conclusion............................................................................................................ SLIDE 36 Appendix Slide.............................................................................................................................. SLIDE 40 3 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
PRESENTATION OVERVIEW
1 2 3
Our Where Large
Mission We Are Market
Today Opportunity
4 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
OUR MISSION Enable Early Ovarian Cancer Detection for All Ages and Race / Ethnicities 5 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
INVESTMENT HIGHLIGHTS
COMMERCIAL
FDA-CLEARED
STAGE COMPANY PIPELINE
TECHNOLOGY
FDA-cleared multi-modal Compelling pipeline of diagnostic
2nd-generation technology;
disease management approach bioinformatic product candidates
included in clinical treatment
to women’s health, with core
guidelines
focus on ovarian cancer
INTELLECTUAL MANAGED CARE EXPERIENCED
PROPERTY COVERAGE MANAGEMENT
Broad managed care coverage:
Strong intellectual property Experienced management team
2018 CLFS* reimbursement rate
protecting methods and use focused on success
of $897
*
Clinical Lab Fee Schedule
6 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
MANAGEMENT TEAM
Leadership team with significant industry and execution expertise
Elena Ratner, MD
Global Chief Medical Advisor, Clinical and Translational Medicine
Valerie Palmieri Gynecologic oncologist specializing in ovarian malignancies
President & CEO She is the current co-director of Discovery To Cure, director of Discovery to Cure Early
Ovarian Cancer Detection program
30+ years of senior and executive leadership experience
in the diagnostics and laboratory industry Co-founder of the MAT Organization; a non-profit established to drive early detection for Ovarian Cancer
Served in numerous sales, operations and executive
leadership positions, including as CEO and President of
MOMENTUM Consulting
Kaile Zagger
Chief Operating Officer
20+ years in healthcare leadership experience
Co-founder of the MAT Organization; a non-profit established to drive early detection for Ovarian Cancer
Robert Beechey
Chief Financial Officer Lesley Northrop, Ph.D., DABMGG, FACMG
Chief Scientific Officer
18+ years serving in numerous life science and financial
14+ years of experience in developing new technology as it translates from research to a clinical
leadership roles
diagnostic test
B.S. in Economics from the Wharton School of the Serves as a Laboratory Director of Aspira’s Molecular Genetics Laboratory, holds a NYS CQ in
University of Pennsylvania, and his M.B.A. from INSEAD molecular genetics and CA-CPDH and NJ Bioanalysis Director license
Diplomate of the American Board of Medical Genetics and a Fellow of the American College of
Medical Genetics, specializing in- Molecular Genetics
7 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
ASPIRA WOMEN’S HEALTH’S EVOLUTION
ONGOING
Replace Standard of Care
& Save Lives
OVA1 Plus foundation Expand Commercial
Infrastructure (2020-21)
in place to become COMPLETED
2nd Generation
NEW Standard of Care OVA1 Plus Launch (Q4’18)
Payers (2018-2019)
Payer Coverage:
5 out of 10 lives covered Guidelines (2016-2018)
in the U.S.
Bioinformatic Tools + Current Standard of Care (2016)
Strong IP and FDA-Cleared Science (2010-2018)
8 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
Introduction to
Patient Lifecycle
and Market
9 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
LARGE MARKET OPPORTUNITY WITH THE FOLLOWING PATIENT PROFILES
PELVIC MASS
Planned for Surgery
HIGH RISK
PELVIC HEREDITARY
OVARIAN CANCER
MASS MONITORING
Non Surgical
OVARIAN ENDOMETRIOSIS
CANCER
Recurrence
Monitoring
Large market
opportunity with
20M women in the
U.S.
1 in 5 women
will develop
a Pelvic Mass
10 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
PATIENT LIFECYCLE WITH OVA TECHNOLOGY – SOLVING DIAGNOSTIC DILEMMAS FROM PUBERTY TO CURE
Endo CHECK Key Focus Area
ENDOMETRIOSIS
ONLY JUST ACCEPTED
*
BENIGN
DX + Aid in Detection PELVIC MASS - Current Medical Research
HIGH RISK
Endo CHECK
MANAGEMENT Future Opportunity & Opinion Publication -
Endo CHECK
HEREDITARY SURGICAL TRIAGE
No Surgery Planned
OVARIAN CANCER RISK ASSESSMENT
MONITORING RECURRENCE • T
itle: Low-risk Multivariate
Replace CA125 With Pelvic Mass
2X/year MONITORING Index Assay scores,
Replace CA125 OVA1 Plus Post-OV Ca DX physician referral and
2X/year Current Label surgical choices in women
Companion DX with adnexal masses
or Replace CA125
Late
breaking • 282 patients
publication*
OPPORTUNITY/ • 146 low risk
CLINICAL DX NEEDS
TO CORRESPOND
TO IMAGING 0.2M
• 4
4% of the low-risk OVA1
IMMEDIATE 0.3 to patients, no surgical
OPPORTUNITY 0.4M1 intervention was performed
NEAR TERM 0.3 to
OPPORTUNITY 0.5M
LARGEST IMMEDIATE 1.2 to
CLINICAL OPPORTUNITY 1.5M • D
EMONSTRATES CLINICAL
PROBLEM AND NEED FOR OVANex
OPPORTUNITY 6.7M
Puberty Cure
(~14 yo.) (70-80 yo.)
1. Based on management estimates and analysis
11 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.LARGE BENIGN AND MALIGNANT PELVIC MASS MARKET U.S. ONLY
MASS MARKET
Suboptimal diagnostics and high cost burden
Large Opportunity Solutions Today Our Solutions Costs
NONE Endo CHECK
Pelvic Masses + (Endo + PCOS+ Func. Cysts)
TAM: 17.0M $26B
(2023 Target Date)
Pelvic Masses (Benign, cancer, non-gyn) CA125 / 2-4x per year
TAM: 1.2-1.5M (Off Label Use)
(Late 2021/ 1H2022)
High Risk Hereditary
Ovarian Cancer Monitoring CA125 / 2x per year $0.8B
(Off Label Use)
TAM: 300K - 500K (Target Date TBD)
Endo CHECK
Endo CHECK
Masses to Surgery
TAM: 300-400K
(OVA1, OVERA, FDA Cleared) (OVA1, OVERA, FDA Cleared)
Ovarian CA125 Recurrence Portfolio
Cancer
Monitoring Expansion $5.2B
TAM: 230K (FDA Cleared)
OC
Deaths
TAM: TOTAL: $32B
15K
TOTAL: ~20M Women
12 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.INN TION PIPELINE TIMELINE
Ovarian
1H2023 E Asymptomatic
Risk Screening
1H2022 E
2021 Endo CHECK A multifactorial assessment of
gynecological cancer risk
Endo CHECK
A companion
(Research Trial to begin: 2H 2020 E)
diagnostic to
identify women
Q3 2019 A watch and wait with Endometriosis,
test for women with PCOS etc.
Q4 2018 adnexal masses
A technology transfer
platform for Aspira
Women’s Heath products
Endo CHECK
Hereditary Cancer Carrier Screening
13 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.ENDOMETRIOSIS A SIGNIFICANT UNMET NEED TRANSLATING INTO A MULTIBILLION MARKET
$26/69B/yr 6-7million
(healthcare / total economic burden)
7-9 years
women affected in the on average to diagnose
total U.S. costs from direct costs,
U.S. by Endometriosis1-2 Endometriosis
lost workdays and complications
Quality of life Health burden cost
premenopausal women may for Endometriosis in the U.S. were approximated at
experience heavy menstrual $4,000 per affected woman in 2008 - similar to the
bleeding, anemia, bloating, costs for other chronic conditions such as type 2
infertility, pain and swelling diabetes, Crohn’s disease, and rheumatoid arthritis3
Biomarker-based blood test
to help identify women with Endometrosis could help by shortening the time for treatment
and guiding more effective treatment plans
1. Fuldeore MJ, Soliman AM. Prevalence and Symptomatic Burden of Diagnosed Endometriosis in the United States: National Estimates from a Cross-Sectional Survey of 59,411 Women. Gynecol Obstet Invest.
2017;82(5):453-461. doi: 10.1159/000452660. Epub 2016 Nov 8. PMID: 27820938.
2. Buck Louis GM, Hediger ML, Peterson CM, Croughan M, Sundaram R, Stanford J, Chen Z, Fujimoto VY, Varner MW, Trumble A, Giudice LC; ENDO Study Working Group. Incidence of endometriosis by study
population and diagnostic method: the ENDO study. Fertil Steril. 2011 Aug;96(2):360-5. doi: 10.1016/j.fertnstert.2011.05.087. Epub 2011 Jun 29. PMID: 21719000; PMCID: PMC3143230.
3. Sarawat L, Ayansina D, Cooper KG, et al. Impact of endometriosis on risk of further gynecological surgery and cancer: a national cohort study. BJOG 2018; 125(1): 64-72. doi: 10.1111/1471-0528.14793.
14 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.FOUNDATION: MULTI-MODALITY VS SINGLE MODALITY APPROACH TO CARE
(Technology Evaluation Process / OVAInherit Trial Name)
Cutting Edge Research
with leading academic
Protein
Biomarkers
Additional
Technology
institutions
OVA360: Multimodal
assessment of
OVA360 ovarian cancer risk
Research collaboration
announced November
Family History 19, 2020.
Clinical
Assessment Genetic Predisposition
& Imaging
+ Symptom Early Symptom Awareness - Indexed
Index Hereditary
Breast & Ovarian Clinical Assessment - TVUS
Cancer (HBOC)
Genetics Systematic Assessment - Proteins, Genetics
15 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.Starting with
Ovarian Cancer
16 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.PRESENTATION STAGE AND 5-YEAR SURVIVAL RATE1 Presentation Stage Incidence Five Year Survival Rate (Stage I) Localized 15% 92% (Stage II) Regional 21% 75% (Stage III) Distant 59% 29% (Stage IV) Unstaged 6% 24% Clinical Need for a Diagnostic Solution Ovarian with Adequate Predictive Value to: Cancer • Ensure earlier cancer detection >65% Late Stage • Accurately identify patients needing timely @ Late Stage >70% treatments from gynecologic oncologists Mortality Rate 1. www.SEER.Cancer.gov. 17 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
ROOT CAUSE: INADEQUATE TOOLS
Category Tools Limitations
CLINICAL Physical exam ubjective results
S
due to specialists’
ASSESSMENT & ultrasound
interpretation
BLOOD • CA-125 (off-label) • Low sensitivity
TUMOR • ROMA™(alternative) • High false negatives,
MARKER (pre-menopausal / early-stage)
TISSUE Pre-operative
Biopsy rupture risks
biopsy not
ANALYSIS recommended (potential tumor spread)
18 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.CURRENT CARE PATHWAY – MAJORITY OF CASES UNCERTAIN
CLEARLY
BENIGN Watchful Waiting / Management of Symptoms
(27%)
Level A guideline
for pelvic mass LEVEL B
INEFFECTIVE CARE PATHWAY RESULTS
LEVEL A GUIDELINE
assessment results Unclear Results
(CA-125)
Late-stage detection (65%)2
Pelvic Mass
in ~70% unclear Transvaginal (~70% of Cases 1 Gynecological oncologist referral delay (40%)4
Ultrasound (TVUS) ~400K Patients)1
results and leads (0.5M – 1M Patients) 1
High cost with no improvement in clinical
outcomes ($5B3 of U.S. annual costs with
to ineffective care 52+% mortality2)
pathway CLEARLY
CA-125 & Immediate Referral to Gynecological Oncologist
MALIGNANT
(3%)
1. Based on management estimates and analysis. 2. www.SEER.Cancer.gov. 3. Estimates from Projections of the Cost of Cancer Care in the United States:2010–2020, J Natl Cancer Inst 2011;103:117–128.
4. Racial Disparities in the Receipt of Guideline Care and Cancer Deaths for Women with Ovarian Cancer Cronin Et al 2018 Nov Cancer Epi Prev Biom.
19 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.CURRENT STATE: EARLY STAGE FALSE NEGATIVE RATE 31-59%
A low false negative rate is critical for patient care
Early Stage Early Stage False
Sensitivity (%) Negativity Rate (%)
Clinical assessment (CA)1 68.6 31.4
Standalone Risk Stratification
Ultrasound alone2 41.2 58.8
CA125 alone1 62.8 37.2
ROMA (Ca125 & HE4)3-4 63.6 36.4
OVA1® alone5 91.4 8.6
Demonstration of Improvement Reducing
False Negatives by Over 72% vs. Clinical
Assessment (CA-125 & ultrasound)
1. Longoria, TC et al. AJOG Jan 2014, 210(1,): 78.e1-78.e9. 2. Pavlik EJ, van Nagell JR Jr. Womens Health (Lond). 2013 Jan;9(1):39-55.
3. Partheen K, Kristjansdottir B, Sundfeldt K. J Gynecol Oncol. 2011;22(4):244-52. 4. Chudecka-Glaz, A et al. J Mol Biomark Diagn. 2013, S4:003.
5. Bristow, RE et al. Gynecol Cncol. 2013, 128:252-259.
20 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.IMPROVED SPECIFICITY: OVA1 PLUS - OVA1/OVERA REFLEX OFFERING (Q4 2018)
If Results Are... Reported Results are...
Low Risk OVA1®
Perform Perform
® Intermediate Risk ®
OVA1 OVERA
Markedly
Elevated Risk OVA1®
OVA11 Overa2 OVA1plus % Diff
(95%CI) (95% CI) Premenopausal3 Risk 5.0-7.0
(95% CI) OVA1 vs OVA1plus
LOW INTERMEDIATE ELEVATED
Sensitivity 92% 91% 88% -4% < 5.0 5.0-7.0 > 7.0
Postmenopausal2 Risk 4.4-6.0
Specificity 54% 69% 72% 33% LOW INTERMEDIATE ELEVATED
< 4.4 4.4-6.0 > 6.0
> 30% improvement in specificity
1. Bristow RE, et al., Gynecol Oncol. 2013;128:252-259
2. Coleman RL, Herzog TJ, Chan DW, et al. Validation of a second-generation multivariate index assay for malignancy risk of adnexal masses. Am J Obstet Gynecol 2016;215:82.e1-11.
3. Reference Ranges established by ASPiRA Labs, Austin Tx.
21 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.AIDS IN IMPROVED EARLY STAGE DETECTION: OVA1 PLUS VS. STANDARD OF CARE (STAGE I + II)
Rate of Cancer
MISSED
94% Improvement in reducing the rate of cancer missed
Rate of Cancer
DETECTED
100%
37% 31% 23% 13% 2%
87% 98%
77%
69%
63%
50%
0%
CA-125II* CA-125 & Clinical Modified OVA1Plus OVA1Plus
Assessment ACOG** & Clinical
Assessment
(n = 1016 surgeries, with 86 early stage cases, 61 Stage 1, 25 Stage II)
* Significant difference in sensitivity as compared to OVA1+ Clinical Assessment (from McNemar’s test pDisparity Gap Review
NON-WHITE WOMEN, AND AFRICAN-AMERICAN WOMEN IN PARTICULAR,
DISPLAY SIGNIFICANTLY LOWER CA125 VALUES COMPARED TO CAUCASIAN WOMEN
This disparity is found in healthy women, women at high risk for
ovarian cancer, and women with ovarian cancer(1-4)
CA125 (%, Caucasian Value is 100%)
BABIC ET AL. 2017 CRAMER ET AL. 2010 PAULER ET AL. 2001 SKATES ET AL. 2011
(Post-menopausal) (Pre-menopausal)
100
75
50
25
0
Caucasian African American Caucasian African American Caucasian African American Caucasian African American Caucasian African American
or Non-White or Non-White or Non-White or Non-White or Non-White
3446 (Caucasian) 1645 (Non-white) 582 (Caucasian) 35 (Non-white) 17852 (Caucasian) 89 (Non-white) 1604 (non-African- 52 (African- 1968 (non-African- 68 (African-
American) American) American) American)
1. Pauler, D., et al. Factors Influencing Serum CA125II Levels in Healthy Postmenopausal Women. Cancer Epidemiology, Biomarkers & Prevention, 10: 489-493, 2001.
2. Skates, S., at al. Large Prospective Study of Ovarian Cancer Screening in High-risk Women: CA125 Cut-point Defined by Menopausal Status. Cancer Prevention Research, 4(9), 1401–1408, 2011.
3. Cramer, D., et al. Correlates of the pre-operative level of CA125 at presentation of ovarian cancer. Gynecologic Oncology, 119(3), 462–468, 2010.
4. Babic, A., at al. Predictors of pretreatment CA125 at ovarian cancer diagnosis: a pooled analysis in the Ovarian Cancer Association Consortium. Cancer Causes & Control : CCC, 28(5), 459–468, 2017.
23 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.Disparity Gap Review
OVA1® SUPERIORITY OVER CA125 IN BLACK WOMEN
• CA125 has an
• OVA1 has a 46-16.7% higher rate of detection (sensitivity) for • OVA1 has a 25% higher rate of detection (sensitivity) for ovarian unacceptable sensitivity
ovarian malignancy vs. CA-125 in Black women1 malignancy vs. ROMA (CA-125 & HE4) in White women2 for cancer detection in
Black women
OVA1 vs CA-125 OVA1 vs ROMA • Aug and Sept 2019
- 2 peer reviewed
BLACK WHITE
100
BLACK WHITE publications published
100
• OVA1® shows
acceptable sensitivity
75 75
for cancer detection in
Black women, cutoff
SENSITIVITY
SENSITIVITY
50 50 adjustment is in process
93.2% 93.2%
82.9%
for pre- and post-
79.2% 80.4% 79.1%
74.4% menopausal women, to
62.5%
25 25 54.5% achieve 90% sensitivity
33.3% obtained for White
women3
0 0
CA-125 CA-125 OVA1 CA-125 CA-125 OVA1 ROMA OVA1 ROMA OVA1 • Large prospective study
with a 200 U/ml with a 67 U/ml cut with a 200 U/ml with a 67 U/ml cut
cut off (ACOG) off (Dearking) cut off (ACOG) off (Dearking) in process with Einstein
2007 2007 2007 2007
Medical Center
*ACOG 2016= Premenopausal cutoff = very elevated
1. Dunton, C., Bullock, R., Fritsche, H.A., (2019). Ethnic disparity in clinical performance between multivariate index assay and CA125 in detection of ovarian malignancy. Future Oncology, https://doi.org/10.2217/fon-2019-0310
2. Dunton, C., Bullock, R., Fritsche, H.A., (2019). Multivariate Index Assay Is Superior to CA125 and HE4 Testing in Detection of Ovarian Malignancy in African-American Women. Biomarkers in Cancer, 11 (1-4), https://doi.
org/10.1177/1179299X19853785
3. ASPiRA Labs Data on File, Combined OVA1 and OVA500 studies.
24 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.EARLY DETECTION LOWERS TOTAL HEALTHCARE COSTS
Cost Comparison of Early vs. Late Stage Detection1,2
Pre-Menopausal
Late Stage Detection 93K medical claims
Post-Menopausal study demonstrated that
$224,922 Late Stage Detection
the use of OVA1 Plus
$197,757 compared to CA-125 II
can lower total costs
while improving care
84% Decrease 81% Decrease
in Cost Burden in Cost Burden
Post-Menopausal
Pre-Menopausal Early Stage Detection
Early Stage Detection
$37,195
$35,754
1. 24-Month Average Reimbursement for Early and Late Stage Cancer. 2. Brodsky B.S., Owens G.M., Scotti, D.J., et al. AHDB. 2017:10(7):351-359
3.Lindsey A. Torre, Farhad Islami, Rebecca L. Siegel, Elizabeth M. Ward and Ahmedin Jemal. Cancer Epidemiol Biomarkers Prev April 1 2017 (26) (4)
444-457; DOI: 10.1158/1055-9965.EPI-16-0858; WHO fact sheet.
.
25 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.A Growing
Total Addressable
Market
26 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.LARGE AND GROWING TOTAL ADDRESSABLE MARKET
Long-Term Addressable Opportunity
Near-Term Addressable Opportunity
HIGH RISK HEREDITARY
OVARIAN CANCER MONITORING
Currently Addressable Opportunity BENIGN MASSES,
NON-OVARIAN CANCER • ~300-500K U.S. patients
PELVIC MASS DETECTION
• 1.2-1.5M U.S. patients • Current: CA-125 2-4x/yr
• Surgical triage or guided monitoring (off-label)
• Current: CA-125 2-4x/yr
referral: ~300-400K U.S. monitoring (off-label) • AWH: OVAInherit TBD
patients and low risk
• AWH: OVANEX (1H2022) OVARIAN CANCER
• ~5% AWH market share
RECURRENCE MONITORING
• Current/AWH: OVA1plus ENDO + PCOS+ FUNC.
CYSTS DETECTION • ~230K U.S. patients monitored
HEREDITARY GYNECOLOGIC • 17M(6.5M=Endo) U.S. patients • Current: CA-125 2-4x/yr
CANCER RISK
• No current solution available / monitoring (on-label)
• Determining risk for
CA-125 used on case by case • AWH: TBD
gynecologic cancers with
genetic testing ~75 K basis (off label)
patients • AWH: EndoCHECK
• AWH: Aspira GenetiX (expected 2023) TOTAL TAM
8.6-10M (20M)
TAM = 375-475K TAM = 7.7-8.0M TAM = 0.5M-0.7M
Total Potential
Potential Revenue Range: $108M - 139M Potential Revenue Range: $1.1B - 4.5B Potential Revenue Range: $130M - 540M Revenue Range: $1.3B - 5.2B
Time
27 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.GROWING SALESFORCE - DRIVING ADOPTION
Full-Time Sales Representative Pedigree
Marketed directly Top performers
20 full-time to gynecologists, in companies
(“FTE”) gynecology with disruptive
territory supergroups, technology
sales reps academics and
healthcare systems
28 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.COMMERCIALIZATION STRATEGY- US + EX US – DECENTRALIZED TESTING
ALGORITHM WAREHOUSE
• Testing Performed in Hospital Systems/Large
Gyn Super Group CLOUD BASED
BIOINFORMATICS
• Increase distribution @ POC (Point of Care) PLATFORM
• Test performed locally with access to Aspira
Women’s Health risk assessment software via web
service
• OVA1 or Aspira GenetiX performed on existing
Platform Customer Aspira Women’s Health
Data Repository
29 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.INTERNATIONAL - COMMERCIAL STRATEGY
PHILIPPINES
Large prospective study in process
International via
Platform/Web
ISRAEL
Service
Q4 2018 – Coverage received in Israel by CLALIT
Both OVA1/Overa
have CE Mark • 2nd largest integrated delivery network in the world
• CLALIT (#1 Payer, 50% pop)
Study in process to validate OVA1Plus on local population
30 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.ASPIRA WOMEN’S HEALTH IS AT A COMMERCIAL INFLECTION POINT
Total Physicians (Distinct Physicians)
3000
2500
2000
1500
1000
500
0
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2018 2019 2020
31 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.ASPIRA WOMEN’S HEALTH IS AT A COMMERCIAL INFLECTION POINT
March Decrease Due to
COVID-19 Closures
4,000
PHASE 1 PHASE 2
HIRING HIRING
3,900 3,854
3,700 3,654 3,849
3,602 3,596
COMMERCIAL
3,500
GROWTH PHASE
2.5x commercial
3,300 investment Y-o-Y &
3,129 demonstrated positive
3,100 Ob-Gyn reception
Launch of Decentralized
Platform & 2nd Generation/OVA1 Plus
2,900
2,700
6 FTEs
2,500 Territory Sales Rep
2,313
2,300 2,458
2,100
1,981
1,884 1,996
1,900 1,818 20 FTEs
Territory Sales Rep,
1,700 Total 30 FTEs
Evicore Live
PAMA Rate
1,500
Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3 2020 Q4 2020
32 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.A Review of
Financials and
Market Access
33 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.FINANCIAL AND OPERATING PERFORMANCE
1 2 3 4 5 6
Grow Base Margin Expansion Reimbursement
Sales Market Share
Revenue and and Leverage Profitability and Revenue Cycle
Adoption Capture
Unit Growth Fixed Costs Management
FY19 VS. FY18 3Q2020 vs 2Q2020 CASH POSITION
Cash September 30, 2020
Product volume Product volume
$19M
INCREASED 69% INCREASED 46%
12,898 units in FY19 vs. 7,679 units in FY18 3,596 units in third quarter 2020 vs. 2,458 Includes funds received for:
units in second quarter 2020 Capital Raise
Product Revenue
Product Revenue $11M
INCREASED 58%
$4.4M in FY19 vs. $2.7M in FY18 INCREASED 68% State of CT Loan
$1.2M in third quarter 2020 vs. $2M1
Total Customers $.726M in second quarter 2020
INCREASED 56%
Total Customers
New Customers INCREASED 37%
INCREASED 56%
1. Received in Q4
34 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.REIMBURSEMENT AND MARKET ACCESS
Coverage: Patient Lives In Millions
Texas Montana Oklahoma
173M Georgia
Tennessee New Mexico Arizona
Illinois
Cigna added OVA1 to its
120M
national preferred coverage
list in January 2019
51% of the population now
under positive coverage
100M
GOAL
Targeted Growth
CareFirst with Positive Medical
Louisiana Policy Decisions
80M Arkansas Unprecedented
Michigan reimbursement
success
0M
35 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.Wrap Up and
Conclusion
36 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.CATALYST DRIVEN MOMENTUM THROUGH 2020
INCREASED ADOPTION OF OVA1PLUS & ASPIRA GENETIX
(H1 2020)
INCREASED PAYER COVERAGE TO 173M LIVES (H1 2020)
• 114M in contracts to 155M in contracts in 2020
OVA1PLUS ABSTRACT PUBLISHED APRIL 2020
PAMA RATE ESTABLISHED
EXPANDED MARKET ACCESS VIA CIGNA
CLINICAL STUDIES LAUNCHED:
(Watch and Wait)
• Q1 2019: Cigna added OVA1 to its national / OVA360
EVICORE GUIDELINES
preferred coverage list
DISPARITY
Endo
PAYER COVERAGE (128M)
Endo CHECK
• 15 M lives added (167 M) ACADEMIC RESEARCH PARTNERSHIP(S)
CHECK
EXPANDED SALES TEAM Endo CHECK - Clinical Validation
HEREDITARY BREAST AND OVARIAN CANCER
• Phase I hiring completed Q3 2018 (9 FTE) (HBOC) GENETICS PROGRAM LAUNCH
(JUNE 2019)
• Phase II hiring completed Q1 2019 (11 FTE) (ASPIRA SYNERGY Technology Transfer)
CLINICAL ASSESSMENT & IMAGING SYMPTOM
INDEX (Q3 2019) TOP 3 PLANNED 2021 PUBLICATION LIST
CA-125II DISPARITY VALIDATION • OVAnex analytical validation
LAUNCHED NATIONAL CLINICAL STUDY OF • AGTT analytical validation
Q4 2018 presented CA125 disparity data at the OC RISK DETECTION METHODS IN AFRICAN
Mid-Atlantic Gynecologic Oncology Society AMERICAN WOMEN • Endocheck analytical and retrospective clinical validation
Focus Area Commercial Expansion Portfolio Expansion Partnership Expansion
and Timing 2018-2019 2019 2020+
37 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.COMPELLING GROWTH STRATEGIES
Expand Distribution
Platform
Beyond the U.S. by
launching OVA1Plus
while building the
clinical utility and health
Enterprise Value
economics foundation
Expand Product
Pipeline;
Expand TAM
Offer pelvic disease
diagnostic and
prognostic solutions
from puberty to cure
Become the from endometriosis
Standard of Care for and ovarian cancer
Global Pelvic Mass
Risk Assessment
Leverage the Largest
Specimen and Data
Repository
of gynecologic pelvic
mass patients worldwide
38 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.IN SUMMARY
1 2 3
Where We Large Market
Our Mission Are Today Opportunity
Commercial Stage Company
Solving a Huge with FDA-cleared, Strong pipeline with a
Global Healthcare Problem guideline, and payer 20M Market Opportunity
endorsed technology
39 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.Appendix 40 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.
OUR SOLUTION = OVA1® + OVERA® (OVA1 PLUS)
Apolipoprotein Beta 2
CA-125II Prealbumin Transferrin
Protein A1 microgloblin
• OVA1 evaluates the levels of five ovarian Function Cholesterol Host immune Released by Hormone
Transport response tumor cells and vitamin Iron transport
cancer-associated markers in the blood transport
• Levels combined into single cancer risk score. DOWN UP UP DOWN DOWN
Multi-variate Index Assay (MIA) in ACOG Guidelines
Positive NCCN and SGO position statements
Apolipoprotein HE4 (Human FSH (Follicle
CA-125II Transferrin
• Overa incorporates 2 new markers Protein A1 Epididymis protein 4) Stimulating Hormone)
• Global Platform Function Cholesterol Released by Released by Hormone
Iron transport
Transport tumor cells tumor cells regulation
• Increased Specificity
DOWN UP UP DOWN
41 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.OVA1 PLUS IMPROVES EARLY STAGE DETECTION
Comparison of CA-125II vs. OVA1Plus
CA-125II
Sensitivity Across All Ovarian Cancer Stages1
Stage I
Stage II
Stage III
Stage IV
Sensitivity Across Menopausal Status1
Pre-menopausal
Post-menopausal
Sensitivity Across Histological Subtypes1
Epithelial ovarian cancer
Non-Epithelial ovarian cancer
Low malignant potential
Metastatic
Other gyn cancer
Sensitivity Across All Ethnicities2
Caucasian and African American
1. Longoria T.C. et al. Am J Obstet Gynecol 2014;210:78 e1-9.
2. From company’s 2019 AACR Abstract 1244, “Ethnic disparity in ovarian malignancy tumor markers: MIA and ROMA.”
42 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.TRUSTED SOLUTION: CARE PATHWAY GUIDELINES
Published Evidence OVA1 (MIA) Guidelines / Position Statements1
Obstetrics and Gynecology, 2011
Gynecologic Oncology, 2013 Am J Gynecol, 2013 ACOG Practice Bulletin
Am J Obstet Gynecol, 2014 Number 174, November 2016, page
Am J Obstet Gynecol, 2014
Curr Med Res Opin, 2015
National Comprehensive Cancer Network
Am J Obstet Gynecol, 2016 Guidelines, Version 5, 2017
Am J Obstet Gynecol, 2016 Updated Feb 2, 2018
Int. J Gynecol Cancer, 2017, Gynecologic Oncology, 2018
Am Health & Drug Benefits, 2017 Society of Gynecologic Oncology
Advances in Therapy, 2019 Position Statements Issued 201
Journal of Surgical Oncol, 2019 Updated 2013
Biomarkers in Cancer, 2019
Future Oncology, 2019 American Cancer Society
Future Oncology, 2019 What’s new in Ovarian Cancer Research? (Diagnosis)
Current Medical Research and Opinion, 2020 Revised April 11, 2018
1. In 100% of all Key Guidelines
43 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.PROTECTED SOLUTIONS: STRONG IP
Issued patents Pending patent
covering various applications including Algorithm:
ovarian cancer OVA1 and Overa kept as trade
biomarkers products secret
GRANTED PENDING (Approx.)
USA Ex US Total USA Ex US Total FAMILY
20 65 85 9 31 40 24
44 Copyright © Aspira Women’s Health Inc., 2021. All Rights Reserved.You can also read
