Biomerica, Inc. · NASDAQ:BMRA
Biomerica — Investor Presentation (November 2022)
30 slides from Biomerica's investor presentation, Nov 14, 2022
Slide 1: Investor Presentation Nov 2022
Slide 2: Forward-Looking Statement
Forward-Looking Statement The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this presentation (as well as information included in oral statements or other written statements made or to be made by Biomerica) c
Slide 3: Diagnostic Guided Therapy
Diagnostic Guided Therapy Using Science, Diet and Technology to Revolutionize the GI Market BIOMERICA ©)inFoods
Slide 4: Investment Highlights
Investment Highlights Disruptive Patented Platform Technology redefining the GI Market First ever FDA-regulated diagnostic therapy Large Growing Market + $30+ Billion expansive market opportunity + Robust patent portfolio (11 issued patents; 100+ patents pending) Significant Milestones Driving Growt
Slide 5: Leadership, Board & Depth in Science
4 Leadership, Board & Depth in Science Management ZACK IRANI + Chief Executive Officer & Chairman + Previous CEO & Chairman of Lancer Orthodontics Inc. ALLEN BARBIERI + Executive Vice Chairman + Previous CEO of numerous public and private companies + Board member at CareTrust REIT STEVE SLOAN + Chie
Slide 6: Background & Innovation
BIOMERICA Background & Innovation Leveraging diagnostic expertise to transition into diagnostic-guided therapeutics © inFoods Disruptive patented technology platform enabling diagnostic therapies Specialty diagnostics enabling early disease detection and monitoring Two FDA, CE, CFDA registered manuf
Slide 7: InFoods - Diagnostic Guided Therapy (DGT)
InFoods® - Diagnostic Guided Therapy (DGT) Personalize Medicine for IBS patients Example of Patient-Specific Results Result Chicken NEGATIVE Z f Cabbage NEGATIVE S) FDA-regulated diagnostic to be used as therapy Egg -#POSITIVE Garlic NEGATIVE <5) Measures immunoreactivity for a panel of foods to det
Slide 8: Irritable Bowel Syndrome (IBS) is Very Common and Costly
Irritable Bowel Syndrome (IBS) is Very Common and Costly ‘Recent AGA Survey (American Gastroenterological Association), BIOMERICA. IBS is the #1 most common diagnosis made by gastroenterologists' IBS patients visit doctors 3x more than non-IBS patients IBS is the #7 most common diagnosis made by all
Slide 9: IBS Market is Significant Today and Growing
IBS Market is Significant Today and Growing 4 Million IBS Patients in the US $30B+ U.S. TAM! 1/3 IBS-C 1/3 IBS-M (Mixed: (Constipation) Alternates C+D) ~1 6 US IBS Patients: ~1 3 IBS-M Patients: seeking consistent No approved MILLION _ physician treatment MILLION therapy/drug? ‘Global prevalence of
Slide 10: InFoods IBS: Broad Benefits to Patients, Physicians, and Healthcare Insurers
InFoods® IBS: Broad Benefits to Patients, Physicians, and Healthcare Insurers Patient Benefits Physician Benefits Payer/insurer Benefits InFoods® targets underlying InFoods®: Recurring revenue InFoods® insurer savings causes without causing potential as problem foods Currently: IBS Patients require
Slide 11: FDA Approved Drugs are Expensive and have Efficacy and Safety Limitations
FDA Approved Drugs are Expensive and have Efficacy and Safety Limitations FDA Treatment Placebo Treatment Monthly Annualized Approval Response Response minus Placebo Cost U.S. Sale Indication Limitations + Diarrhea side Linzess 2012 20% - 34% 6% - 27% 7% - 14% $467 $1,963M effect (20%) + Indicated f
Slide 12: Biomerica First-Generation Product vs. Lotronex
Biomerica First-Generation Product vs. Lotronex™ (Diarrhea Stool Frequency: an FDA endpoint) IBS-Diarrhea =@=Alosetron <®=Food IgG ¢ 120% 7B 100% Alosetron (Lotronex™) 0 £8 Drop from Baseline: 30 % o2 80% —— Fs E 60% oo rd + 40% , oe 3 Biomerica First-Gen Product 65% £5 20% Drop from Baseline: (1) “
Slide 13: InFoods Regulatory & Commercial Pathway
InFoods® Regulatory & Commercial Pathway CLIA Lab Developed Test Dual Path otal Trial 14 month: S) Recently competed Endpoint Trial results driving significant interest from physician groups FDA Approval FDA has determined proposed IBS 5S) CLIA Lab Developed Test to be clinical study is a non-signif
Slide 14: InFoods IBS: Clinical Trial Design Summary
InFoods® IBS: Clinical Trial Design Summary Randomized Double Blinded Placebo controlled Patient is InFoods positive to: Blueberries & Almonds OinFoods Treatment Arm Placebo Arm Eliminates Eliminates Blueberries & Almonds Raspberries & Walnuts (if negative and same consumption) Copyright © 2022 Biom
Slide 15: Highlights InFoods IBS
Highlights InFoods® IBS Statistically meaningful improvements were Top Line - Global Endpoints seen in multiple endpoints (symptoms), this is only a selection of topline results from the InFoods® IBS endpoint trial OiinFoods Treatment Arm Vs. Placebo Arm Global Endpoints SGA 2 P-value of 0.007 for i
Slide 16: Highlights InFoods IBS: Pain and Bloating
1 2. Highlights Statistically meaningful improvements were seen in multiple endpoints (symptoms), this is only a selection of topline results from the InFoods® IBS endpoint trial Pain and Bloating API Bloating InFoods® IBS Top Line - Global Endpoints OinFoods Treatment Arm Vs. Placebo Arm P-value of
Slide 17: Abdominal Pain Index (API) Change from Baseline
Abdominal Pain Index (API) Change from Baseline IBS non-D Population 0 Increased Abdominal 0.2 Pain -0.4 aos - ges 0.6 £Ss Ta> Bog 08 bee Us 41 “1.2 Decreased Abdominal A 1.4 Pain -1.6 0) 2 4 8 Weeks on Diet Linear Mixed Model —True Diet —Sham Diet Wk 8 P-Value 0.0139 BIOMERICA-> Copyright © 2022 Bi
Slide 18: Bloating Change from Baseline
Bloating Change from Baseline IBS non-D Population Less Relief Bloating Change in Bloating Least Squares Mean Values More Relief Weeks on diet Linear Mixed Model —True Diet —Sham Diet Wk 8 P-Value 0.0214 Copyright © 2022 Biomerica. All Rights Reserved e
Slide 19: InFoods Commercialization Strategy
InFoods® Commercialization Strategy Multiple Avenues to Drive Adoption cS) —) Inclusion in Guidelines Inclusion in the IBS treatment guidelines will accelerate product adoption The Rome Foundation holds significant influence in setting the treatment guidelines Reimbursement Awareness ~S) ) and Enhan
Slide 20: SAB: Rome Foundation - Sets IBS Guidelines
SAB: Rome Foundation- Sets IBS Guidelines Expertise in Clinical Trials Rome Foundation (Leading IBS organization) Leading independent non- profit organization focused on the diagnosis and treatment of functional gastrointestinal disorders, including IBS Rome creates the diagnostic criteria and guide
Slide 21: Platform Technology: InFoods Development Pipeline
Platform Technology: Functional Gastrointestinal Disorders Gastrointestinal Diseases Other Chronic Inflammatory Diseases BIOMERICA-> InFoods® Development Pipeline Ulcerative Colitis (UC) Dermatology Copyright © 2022 Biomerica. All Rights Reserved (21)
Slide 22: Specialty Diagnostics
Specialty ca ae Diagnostics ULCER COLON BREAST = SCREENING 9 DISEASE SELF 9 TEST ow TEST EXAM Foe de on A lal EARLY DETECTION IS In-home results in 2 minutes YOUR BEST PROTECTION
Slide 23: 2022 Growth opportunity - H. pylori
2022 Growth opportunity - H. pylori Detects H. pylori Antigen H. pylori is a bacteria that infects approximately 35% of the U.S. population and 45% of the population in the five major countries in the Europe. Approximately 20% of H. Pylori infected patients develop a range of issues including peptic
Slide 24: Colorectal Disease Test: EZ Detect
Colorectal Disease Test: EZ Detect™ cleared EZ Detect is a 2-minute, at-home test for Quick & Simple: FDA the determination of fecal occult blood, an early warning sign of colorectal cancer a _ (CRC) and other colorectal diseases. No Stool Hand li ng 8B recommended oe EST Self-test for early warning
Slide 25: Key performance metrics for EZ Detect, Cologuard, & FITs
Key performance metrics for EZ Detect”, Cologuard®, & FITs FDA eared Doctor Value EZ Detect™) Cologuard® ?) 8 recommended Nodie $22 restrictions Price $14 $649 Accuracy 93.2% 86.6% 94.7% Positive Likelihood Ratio 91.2 6.9 14.3 a Negative Likelihood Ratio 0.27 0.09 0.28 i C0 LO N Specificity (vs. all
Slide 26: Early Detection is Your Best Protection
EARLY DETECTIONS YOURBEST PROTECTION
Slide 27: Aware Breast Self Exam
Aware® Breast Self Exam FDA - Cleared and CE Mark The Aware® Pad is as an aid for performing at- home breast self-examination About 80% of breast cancers are detected because women themselves notice changes in their breasts! Recurrent purchases and several pads for female family members bitps://www
Slide 28: Aware Performance
Aware® Performance Clinical Study Kawasaki Medical University Hospital for Aware FDA approval (N=832 Patients) 98.6% 90.9%/87.8% 86.4%/65.2% 9.8% Study concluded that Aware® is a highly effective tool Nurse 100% 96.0%/92.0% 86.4%/58.2% 4.8% for early detection of breast abnormalities Regular practic
Slide 29: EZ Detect and Aware available at Walmart and Amazon
“DISEASE TEST Seles for early warning signsofcolorectal ease irhomeesutsin2 mints | ez+detect’ EM Raware’ | Available at Walmart EZ Detect now in over Aware now in over Available online at 1 Walmart >< Walmart Stores Walmart Stores Available at amazon.com a Copyright © 2022 Biomerica. All Rights Res
Slide 30: Leveraging Our Unique Technology
Leveraging Our Unique Technology Disruptive Patented Platform Technology redefining the GI Market Addressing the large need for IBS patients and then targeting multiple other diseases InFoods Model is Unique Benefits Patient / Physician / Insurer Broad IP Protection Robust patent portfolio (11 issue