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AFTERNOON - I AM EXCITED TO SPEAK WITH YOU TODAY AND DISCUSS OUR PLANS FOR 2025 AS WELL AS REVIEW THE SUCCESS BIOAFFINITY TECHNOLOGIES
HAS ENJOYED THIS YEAR.
THIS PRESENTATION, CERTAIN FORWARD-LOOKING STATEMENTS REGARDING BIOAFFINITY TECHNOLOGIES, INC.'S CURRENT EXPECTATIONS AND PROJECTIONS
ABOUT FUTURE EVENTS WILL BE MADE. GENERALLY, THE FORWARD-LOOKING STATEMENTS CAN BE IDENTIFIED BY TERMINOLOGY SUCH AS "MAY,"
"SHOULD," "EXPECTS," "ANTICIPATES," "INTENDS," "PLANS," "BELIEVES,"
"ESTIMATES," AND SIMILAR EXPRESSIONS. THESE STATEMENTS ARE BASED UPON CURRENT BELIEFS, EXPECTATIONS AND ASSUMPTIONS, AND
ARE SUBJECT TO A NUMBER OF RISKS AND UNCERTAINTIES, INCLUDING THOSE SET FORTH IN BIOAFFINITY TECHNOLOGIES' FILINGS WITH THE SEC,
MANY OF WHICH ARE DIFFICULT TO PREDICT. NO FORWARD-LOOKING STATEMENTS CAN BE GUARANTEED AND ACTUAL RESULTS MAY DIFFER MATERIALLY FROM
SUCH STATEMENTS. THE INFORMATION ON THIS CALL IS PROVIDED ONLY AS OF THE DATE OF THIS CALL, AND BIOAFFINITY TECHNOLOGIES' UNDERTAKES
NO OBLIGATION TO UPDATE ANY FORWARD-LOOKING STATEMENTS CONTAINED ON THIS CONFERENCE CALL ON ACCOUNT OF NEW INFORMATION, FUTURE EVENTS,
OR OTHERWISE, EXCEPT AS REQUIRED BY LAW.
TECHNOLOGIES ADDRESSES THE CRITICAL NEED FOR EARLY DETECTION OF CANCER, MORE SPECIFICALLY ITS DEADLIEST FORM, WHICH IS LUNG CANCER. AN
ESTIMATED 18 MILLION PEOPLE IN THE U.S. ARE AT HIGH RISK FOR LUNG CANCER. THE EUROPEAN UNION AND ASIA - WHICH ARE OTHER AREAS IN
WHICH WE HOLD PATENTS - HAVE AN EVEN GREATER NUMBER OF PEOPLE WHO CAN BENEFIT FROM OUR PRODUCTS. FOR EXAMPLE, THERE ARE AN ESTIMATED
300 MILLION SMOKERS IN CHINA ALONE. ACROSS THE GLOBE, EARLY DETECTION OF LUNG CANCER IS VITAL, AND LEADS TO LONGER, HEALTHIER LIVES.
ME GIVE YOU AN EXAMPLE - IN THE U.S., THE OVERALL 5-YEAR SURVIVIAL RATE FOR LUNG CANCER IS 28%. BUT IF CAUGHT IN STAGE 1 AND TREATED,
THE 10-YEAR SURVIVAL RATE JUMPS TO GREATER THAN 90%.
NONINVASIVE, REIMBURSED TEST TO DETECT EARLY-STAGE LUNG CANCER - A TEST WE CALL CYPATH LUNG - HAS SHOWN HIGH ACCURACY IN
DETECTING LUNG CANCER.
INITIAL PRODUCT FOR LUNG CANCER - CYPATH LUNG - THAT I'LL FOCUS ON TODAY HAS A LARGE MARKET. IN THE U.S. ALONE, THE
LUNG CANCER DIAGNOSTIC MARKET IN 2024 WAS ESTIMATED AT 4 BILLION DOLLARS, EXPECTED TO REACH MORE THAN 7 BILLION BY 2030.
I ALSO WANT TO EMPHASIZE THAT WE HAVE A PLATFORM TECHNOLOGY, AND WE ARE DEVELOPING TESTS FOR THE DIAGNOSIS OF OTHER LUNG DISEASES SUCH
AS CHRONIC OBSTRUCTIVE PULMONARY DISEASE - MORE COMMONLY COPD - THAT AFFECTS AN ESTIMATED 14 MILLION AMERICANS AND HAS A
SIMILARLY LARGE DIAGNOSTIC MARKET.
COUNT MANY SUCCESSES IN 2024, INCLUDING OBTAINING REIMBURSEMENT FOR CYPATH LUNG, EXPANDING OUR SALES TEAM WITH EXPERIENCED SALES
PEOPLE WHO KNOW THE PULMONARY MARKET, OBTAINING ACCESS TO THE FEDERAL HEALTHCARE SYSTEM, AND STREAMLINING OPERATIONS.
ACQUISITION OF PRECISION PATHOLOGY SERVICES IN 2023 GAVE US CONTROL OVER LAB OPERATIONS AND 100% OF CYPATH REVENUS.
WORK WE HAVE DONE IN 2024 HAS GIVEN US THE CAPACITY, THE CAPABILITY AND THE EXPERIENCE TO EXPAND OPERATIONS TO MEET THE GROWING DEMAND
FOR CYPATH LUNG AS WE STRATEGICALLY GROW OUR SALES EFFORTS INTO OTHER TARGETED AREAS IN 2025
YEAR'S SALES HAVE SHOWN THAT A GROWING NUMBER OF PHYSICIANS ARE RECOGNIZING THE BENEFIT OF CYPATH LUNG. 2024 HAS BEEN A RECORD
YEAR IN SALES, AND WE LOOK FORWARD TO CONTINUING WITH RECORD GROWTH IN 2025.
YEAR OUR WHOLLY OWNED SUBSIDIARY PRECISION PATHOLOGY LABORATORY SERVICES IS ON TRACK TO REPORT REVENUE OF $9.4 MILLION IN 2024, MORE
THAN 20% GROWTH IN ANNUALIZED REVENUE COMPARED TO 2023 AFTER ACCOUNTING FOR THE ACQUISITION OF PRECISION IN SEPTEMBER 2023. THE INCREASE
IN REVENUE REFLECTS A GREATER THAN 1,700% INCREASE IN SALES OF CYPATH LUNG THROUGH NOV. 30TH, OVER THE SAME PERIOD LAST YEAR.
TO 2025, WE WILL TAKE ADVANTAGE OF OUR SUCCESS THIS YEAR IN GETTING LISTED ON THE FEDERAL SUPPLY SCHEDULE AND MAKING CYPATH LUNG AVAILABLE
TO OUR VETERANS AND ACTIVE MILITARY ACROSS THE COUNTRY. WE ARE FOCUSED ON KEY VA MEDICAL CENTERS THAT SCREEN, DIAGNOSE AND TREAT LUNG
CANCER. THESE 132 DESIGNATED CANCER CENTERS ACROSS THE U.S. HAVE TEAMS OF PATHOLOGISTS, PULMONOLOGISTS AND ONCOLOGISTS WHO CAN SEE THE
BENEFITS OF CYPATH LUNG TO THEIR PATIENTS.
THERE ARE MANY BENEFITS TO CYPATH LUNG:
LUNG IS A PATIENT-FRIENDLY & PHYSICIAN-FOCUSED TEST THAT PROVIDES FOR AT-HOME COLLECTION - MEANING NO NEEDLES AND NO BLOOD.
RESULTS ARE PROVIDED TO PHYSICIAN 2-TO-3 DAYS AFTER THE SAMPLE ARRIVES AT LAB
LUNG IS PARTICULARLY GOOD AT DETECTING CANCER - OR DETERMINING CANCER IS NOT PRESENT - IN PEOPLE WITH SMALL LUNG NODULES
LESS THAN 2 CENTIMETERS. THE RESULTS OF OUR CLINICAL TRIAL, PUBLISHED IN THE PEER-REVIEWED JOURNAL RESPIRATORY RESEARCH - REPORTED
THAT OUR TEST HAD A 92% SENSITIVITY - WHICH IS THE ABILITY OF A TEST TO DETECT A TRUE POSITIVE - AND 87% SPECIFICITY -
WHICH IS THE ABILITY OF A TEST TO DETECT A TRUE NEGATIVE. THE RESULTS ALSO SHOWED A 99% NEGATIVE PREDICTIVE VALUE FOR THE TEST WHEN USED
WITH INDIVIDUALS WITH PULMONARY NODULES LESS THAN 2 CENTIMETERS.
LUNG DIFFERENTIATES PATIENTS WITH CANCER FROM THOSE WHO ARE CANCER FREE USING A TECHNOLOGY CALLED FLOW CYTOMETRY WHICH LOOKS AT POPULATIONS
OF WHOLE CELLS IN A SPUTUM SAMPLE THAT COMES FROM THE LUNG AND THEN ANALYZES THE DATA WITH OUR PROPRIETARY ALGORITHM WE BUILT USING MACHINE
LEARNING. MACINE LEARNING IS A FORM OF AI THAT HAS RESULTED IN STANDARDIZATION AND HIGH PERFORMANCE.
PUT. CYPATH LUNG ANALYZES THE CELL POPULATIONS IN THE LUNG MICROENVIRONMENT TO DETERMINE IF THERE IS A MALIGNANCY PRESENT.
TELL US CYPATH LUNG IS HELPFUL WITH PATIENTS WITH SMALL PULMONARY NODULES. THESE PATIENTS ARE OFTEN ASKED TO WAIT AND SEE IF THE NODULE
GROWS. OR A PHYSICIAN MAY OPT FOR A MORE INVASIVE BIOPSY ONLY TO FIND THAT THE NODULE IS BENIGN. THE UNCERTAINTY IS STRESSFUL FOR BOTH
THE PHYSICIAN AND THE PATIENT. CYPATH LUNG DOES NOT REPLACE THE TOOLS A PHYSICIAN USES TO FIND EARLY CANCER, IT ENHANCES AND ADDS TO
THE TOOLBOX AND CAN BRING MORE CLARITY ON NEXT STEPS FOR BOTH PHYSICIANS AND THEIR PATIENTS.
ARE ALSO WELL AWARE OF THE COSTS TO PATIENTS AND FINANCIAL BURDEN OF HEALTHCARE. AND IN 2024, WE SAW THAT CYPATH LUNG HAS THE POTENTIAL
TO MAKE A SIGNIFICANT, POSITIVE DIFFERENCE.
THIS YEAR, TWO PHYSICIANS PUBLISHED THEIR FINDINGS AFTER ANALYZING THE IMPACT THAT THE USE OF CYPATH LUNG COULD HAVE ON HEALTHCARE COSTS.
IN THEIR ANALYSIS, DR. MICHAEL MORRIS AND DR. SHEILA HABIB ASSUMED CYPATH LUNG WAS PART OF THE STANDARD OF CARE IN 2022 FOR PATIENTS
WITH SMALL PULMONARY NODULES. THEY CONSIDERED THE COST OF FOLLOW-UP, BASED ON PUBLISHED DATA, AND THE SAVINGS IN ADDING CYPATH LUNG TO
THE CARE PATHWAY FOR PATIENTS ON MEDICARE, AND SEPARATELY LOOKED AT THE IMPACT OF USING CYPATH LUNG AS PART OF THE DIAGNOSTIC PATHWAY
FOR PATIENTS WITH SMALL PULMONARY NODULES WHO HAD PRIVATE INSURANCE. THE RESULTS SHOWED CONSIDERABLE SAVINGS. FOR MEDICARE PATIENTS,
USING CYPATH WOULD HAVE RESULTED IN SAVINGS OF MORE THAN $2,700 PER MEDICARE PATIENT OR NEARLY $370 MILLION IN TOTAL SAVINGS IN 2022
TO THE U.S. HEALTHCARE SYSTEM.
FOR THOSE PATIENTS COVERED BY PRIVATE INSURANCE, THE STUDY REPORTED A SAVINGS OF MORE THAN $6,400 PER PATIENT WHICH WOULD HAVE RESULTED
IN NEARLY $900 MILLION IN TOTAL SAVINGS TO THE HEALTHCARE SYSTEM IF OUR TEST HAD BEEN USED WITH PATIENTS IN 2022 WHO HAD PULMONARY NODULES
BETWEEN 6 TO LESS THAN 30 MILLIMETERS.
ME TAKE ONE MOMENT TO TELL YOU ABOUT THE AUTHORS OF THIS STUDY. DR. MICHAEL J. MORRIS IS WITH THE BROOKE ARMY MEDICAL CENTER, THE COUNTRY'S
LARGEST U.S. MILITARY HOSPITAL. HE IS A PULMONOLOGY AND CRITICAL CARE PHYSICIAN AND ASSISTANT DEAN OF RESEARCH AT THE SAN ANTONIO UNIFORMED
SERVICES HEALTH EDUCATION CONSORTIUM. DR. SHEILA A. HABIB IS DIRECTOR OF THE PULMONARY LUNG NODULE CLINIC AND THE LUNG CANCER SCREENING
PROGRAM AT THE SOUTH TEXAS VETERANS' HEALTH CARE SYSTEMS' AUDIE L. MURPHY MEMORIAL VETERANS HOSPITAL - THIS IS ONE
OF OUR NATION'S LARGEST VA HOSPITAL SYSTEMS.
ARE PHYSICIANS WHO RECOGNIZE THE IMPORTANCE OF CYPATH LUNG. AND THERE ARE A GROWING NUMBER OF PHYSICIANS WHO SIMILARLY SEE THE BENEFIT
IN USING OUR NONINVASIVE TEST.
2025, WE WILL WORK WITH PHYSICIANS WHO ARE ADVOCATING ON OUR BEHALF, AND WE WILL TAKE WHAT WE HAVE LEARNED AND HOW WE HAVE IMPROVED THE
PHYSICIAN AND PATIENT JOURNEY, AND WE WILL STRATEGICALLY EXPAND OUR MARKET. SOME OF OUR INVESTORS ON THE CALL WILL REMEMBER THAT WE MADE
A DECISION TO LAUNCH CYPATH LUNG IN A LIMITED MARKET. IN OUR CASE, WE CHOSE TO LAUNCH IN TEXAS, OUR OWN BACKYARD. GRANTED, IT IS A VERY
BIG BACKYARD - IN FACT, BY OUR ASSESSMENT IT IS THE FIFTH LARGEST STATE FOR PULMONARY PRACTICES. THIS APPROACH PROVIDED US THE
ABILITY TO EVALUATE THE MARKET, HONE OUR MESSAGING, BUILD A SALES TEAM AND IMPROVE OPERATIONS.
WILL BE AN EXPANSION YEAR. WE LOOK NOT ONLY TO ENTER THE V.A. AND MILITARY MARKET, BUT ALSO EXPAND TO KEY REGIONS WHERE WE HAVE EXISTING
PRACTICES WHO CAME TO US LARGELY BY WORD-OF-MOUTH FROM OTHER PHYSICIANS. THERE ARE ORDERING PHYSICIANS IN 15 STATES WHO LEARNED ABOUT
CYPATH LUNG FROM A COLLEAGUE OR A PATIENT. WE BELIEVE THOSE ARE THE PRACTICE AREAS WORTH EXPANDING. BUT, OF COURSE, WE WON'T FORGET
TEXAS, WHICH OFFERS FURTHER OPPORTUNITIES FOR GROWTH - BOTH IN INCREASED USE OF OUR TEST WITH EXISTING CLIENTS AND INCREASING OUR
COURSE, WE RECOGNIZE THAT A LARGER MARKET MEANS A GREATER MARKETING EFFORT. MARKETING PLAYS A CRITICAL ROLE IN SALES. WE ESTABLISHED
OUR BRAND WITH THE HELP OF HAVAS HEALTH, AND NOW WE WILL BE WORKING WITH AN EQUALLY WELL RESPECTED, HIGHLY INNOVATIVE MARKETING AGENCY
WITH AN IMPRESSIVE PEDIGREE IN TAKING NEW PRODUCTS TO MARKET IN THE PULMONARY SPACE. IN ADDITION TO INCREASING OUR SALES TEAM, IN 2025
WE LOOK TO HIRE A MARKETING DIRECTOR TO ADD EMPHASIS AND SUPPORT NEEDED TO INCREASE SALES.
ADDITION TO EXPANDING OUR SALES EFFORTS IN 2025, WE ALSO EXPECT TO INITIATE OUR CLINICAL STUDY NEXT YEAR. WE HAVE REPORTED THAT WE INTEND
TO CONDUCT A CLINICAL TRIAL THAT WILL BE THE BASIS FOR SEEKING CLEARANCE OF CYPATH LUNG BY THE FOOD AND DRUG ADMINISTRATION - THE
FDA. WE EXPECT TO BEGIN THIS LARGER CLINICAL TRIAL IN 2025, AND TOWARDS THAT END, WE MET THIS MONTH WITH THE FDA TO DISCUSS OUR TRIAL
DESIGN AND THE TEST'S INTENDED USE, AMONG OTHER TOPICS. WE WERE ENCOURAGED BY THE MEETING, AND WE WILL CONTINUE TO WORK WITH THE
AGENCY AS WE MOVE FORWARD.
PART OF THE CLINICAL TRIAL EFFORT, THE NATIONAL ASSOCIATION OF VETERANS RESEARCH FOUNDATION SENT OUT A "CALL FOR INTEREST"
IN OUR STUDY TO THE VA RESEARCH SYSTEM. I'M PROUD TO REPORT THAT NEARLY 20 VA SYSTEMS HAVE RESPONDED SO FAR, SAYING THAT THEY ARE
INTERESTED IN TAKING PART IN THE STUDY. THESE VA MEDICAL CENTERS ARE IN VARIOUS STAGES OF QUALIFICATION, AND IT IS IMPORTANT TO UNDERSTAND
THAT SOME MAY NOT BE IN THE STUDY FOR VARIOUS REASONS. BUT WE ARE ENCOURAGED BY THE RESPONSE OF THESE PHYSICIANS WHO TREAT OUR VETERAN
POPULATION AND SEE THE NEED TO ADVANCE CYPATH LUNG. IN ADDITION TO THE VA, WE ALSO HAVE A NUMBER OF LARGE PRIVATE AND ACADEMIC MEDICAL
CENTERS THAT ARE IN THE PROCESS OF BEING QUALIFIED AS COLLECTION SITES.
NATIONAL PRINCIPAL INVESTIGATOR FOR THIS TRIAL IS DR. MICHEAL MORRIS OF BROOKE ARMY MEDICAL HOSPITAL WHO I MENTIONED EARLIER. WE EXPECT
SEVERAL ACTIVE MILITARY HOSPITALS WILL BE PART OF THE SITE COLLECTION NETWORK, ALONG WITH VA AND ACADEMIC AND PRIVATE MEDICAL CENTERS.
IT'S AN EXCITING TIME - AND A VERY BUSY TIME - FOR THE COMPANY. AND VERY REWARDING TO SEE THE INTEREST AND ENTHUSIASM