8-K
bioAffinity Technologies, Inc. (BIAF)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 19, 2024
BIOAFFINITY
TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41463 | 46-5211056 |
|---|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation) | (Commission<br><br> <br>File<br> Number) | (I.R.S.<br> Employer<br><br> <br>Identification<br> Number) |
3300Nacogdoches Road, Suite 216
SanAntonio, Texas 78217
(210)698-5334
(Address of principal executive offices and Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e- 4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
| Title<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $.007 per share | BIAF | The<br> Nasdaq Stock Market LLC |
| Tradeable<br> Warrants to purchase Common Stock | BIAFW | The<br> Nasdaq Stock Market LLC |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 | Regulation FD Disclosure |
|---|---|
| On<br> December 19, 2024, bioAffinity Technologies, Inc. hosted a live investor webinar. Attached as Exhibit 99.1 is a copy of the transcript<br> from such webinar. | |
| Item 9.01 | Financial Statements and Exhibits |
| (c)<br> Exhibits | |
| 99.1 Transcript dated December 19, 2024. | |
| 104<br> Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
| Date:<br> December 19, 2024 | BIOAFFINITY TECHNOLOGIES, INC.<br><br> <br>(Registrant) | |
|---|---|---|
| By: | /s/ Maria Zannes | |
| Name: | Maria<br> Zannes | |
| Title: | President<br> and Chief Executive Officer |
Exhibit99.1
GOODAFTERNOON – I AM EXCITED TO SPEAK WITH YOU TODAY AND DISCUSS OUR PLANS FOR 2025 AS WELL AS REVIEW THE SUCCESS BIOAFFINITY TECHNOLOGIESHAS ENJOYED THIS YEAR.
DURINGTHIS PRESENTATION, CERTAIN FORWARD-LOOKING STATEMENTS REGARDING BIOAFFINITY TECHNOLOGIES, INC.’S CURRENT EXPECTATIONS AND PROJECTIONSABOUT 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, ANDARE 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 FROMSUCH STATEMENTS. THE INFORMATION ON THIS CALL IS PROVIDED ONLY AS OF THE DATE OF THIS CALL, AND BIOAFFINITY TECHNOLOGIES’ UNDERTAKESNO 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.
BACKGROUND
BIOAFFINITYTECHNOLOGIES ADDRESSES THE CRITICAL NEED FOR EARLY DETECTION OF CANCER, MORE SPECIFICALLY ITS DEADLIEST FORM, WHICH IS LUNG CANCER. ANESTIMATED 18 MILLION PEOPLE IN THE U.S. ARE AT HIGH RISK FOR LUNG CANCER. THE EUROPEAN UNION AND ASIA – WHICH ARE OTHER AREAS INWHICH WE HOLD PATENTS - HAVE AN EVEN GREATER NUMBER OF PEOPLE WHO CAN BENEFIT FROM OUR PRODUCTS. FOR EXAMPLE, THERE ARE AN ESTIMATED300 MILLION SMOKERS IN CHINA ALONE. ACROSS THE GLOBE, EARLY DETECTION OF LUNG CANCER IS VITAL, AND LEADS TO LONGER, HEALTHIER LIVES.
LETME 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%.
OURNONINVASIVE, REIMBURSED TEST TO DETECT EARLY-STAGE LUNG CANCER – A TEST WE CALL CYPATH LUNG – HAS SHOWN HIGH ACCURACY INDETECTING LUNG CANCER.
OURINITIAL PRODUCT FOR LUNG CANCER – CYPATH LUNG – THAT I’LL FOCUS ON TODAY HAS A LARGE MARKET. IN THE U.S. ALONE, THELUNG CANCER DIAGNOSTIC MARKET IN 2024 WAS ESTIMATED AT 4 BILLION DOLLARS, EXPECTED TO REACH MORE THAN 7 BILLION BY 2030.
BUTI ALSO WANT TO EMPHASIZE THAT WE HAVE A PLATFORM TECHNOLOGY, AND WE ARE DEVELOPING TESTS FOR THE DIAGNOSIS OF OTHER LUNG DISEASES SUCHAS CHRONIC OBSTRUCTIVE PULMONARY DISEASE – MORE COMMONLY COPD – THAT AFFECTS AN ESTIMATED 14 MILLION AMERICANS AND HAS ASIMILARLY LARGE DIAGNOSTIC MARKET.
SALES
WECOUNT MANY SUCCESSES IN 2024, INCLUDING OBTAINING REIMBURSEMENT FOR CYPATH® LUNG, EXPANDING OUR SALES TEAM WITH EXPERIENCED SALESPEOPLE WHO KNOW THE PULMONARY MARKET, OBTAINING ACCESS TO THE FEDERAL HEALTHCARE SYSTEM, AND STREAMLINING OPERATIONS.
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THEACQUISITION OF PRECISION PATHOLOGY SERVICES IN 2023 GAVE US CONTROL OVER LAB OPERATIONS AND 100% OF CYPATH REVENUS.
THEWORK WE HAVE DONE IN 2024 HAS GIVEN US THE CAPACITY, THE CAPABILITY AND THE EXPERIENCE TO EXPAND OPERATIONS TO MEET THE GROWING DEMANDFOR CYPATH® LUNG AS WE STRATEGICALLY GROW OUR SALES EFFORTS INTO OTHER TARGETED AREAS IN 2025
THISYEAR’S SALES HAVE SHOWN THAT A GROWING NUMBER OF PHYSICIANS ARE RECOGNIZING THE BENEFIT OF CYPATH LUNG. 2024 HAS BEEN A RECORDYEAR IN SALES, AND WE LOOK FORWARD TO CONTINUING WITH RECORD GROWTH IN 2025.
THISYEAR OUR WHOLLY OWNED SUBSIDIARY PRECISION PATHOLOGY LABORATORY SERVICES IS ON TRACK TO REPORT REVENUE OF $9.4 MILLION IN 2024, MORETHAN 20% GROWTH IN ANNUALIZED REVENUE COMPARED TO 2023 AFTER ACCOUNTING FOR THE ACQUISITION OF PRECISION IN SEPTEMBER 2023. THE INCREASEIN REVENUE REFLECTS A GREATER THAN 1,700% INCREASE IN SALES OF CYPATH® LUNG THROUGH NOV. 30TH, OVER THE SAME PERIOD LAST YEAR.
LOOKINGTO 2025, WE WILL TAKE ADVANTAGE OF OUR SUCCESS THIS YEAR IN GETTING LISTED ON THE FEDERAL SUPPLY SCHEDULE AND MAKING CYPATH LUNG AVAILABLETO OUR VETERANS AND ACTIVE MILITARY ACROSS THE COUNTRY. WE ARE FOCUSED ON KEY VA MEDICAL CENTERS THAT SCREEN, DIAGNOSE AND TREAT LUNGCANCER. THESE 132 DESIGNATED CANCER CENTERS ACROSS THE U.S. HAVE TEAMS OF PATHOLOGISTS, PULMONOLOGISTS AND ONCOLOGISTS WHO CAN SEE THEBENEFITS OF CYPATH LUNG TO THEIR PATIENTS.
ANDTHERE ARE MANY BENEFITS TO CYPATH LUNG:
CYPATHLUNG 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
CYPATHLUNG IS PARTICULARLY GOOD AT DETECTING CANCER – OR DETERMINING CANCER IS NOT PRESENT – IN PEOPLE WITH SMALL LUNG NODULESLESS THAN 2 CENTIMETERS. THE RESULTS OF OUR CLINICAL TRIAL, PUBLISHED IN THE PEER-REVIEWED JOURNAL RESPIRATORY RESEARCH – REPORTEDTHAT 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 USEDWITH INDIVIDUALS WITH PULMONARY NODULES LESS THAN 2 CENTIMETERS.
CYPATHLUNG DIFFERENTIATES PATIENTS WITH CANCER FROM THOSE WHO ARE CANCER FREE USING A TECHNOLOGY CALLED FLOW CYTOMETRY WHICH LOOKS AT POPULATIONSOF WHOLE CELLS IN A SPUTUM SAMPLE THAT COMES FROM THE LUNG AND THEN ANALYZES THE DATA WITH OUR PROPRIETARY ALGORITHM WE BUILT USING MACHINELEARNING. MACINE LEARNING IS A FORM OF AI THAT HAS RESULTED IN STANDARDIZATION AND HIGH PERFORMANCE.
SIMPLYPUT. CYPATH LUNG ANALYZES THE CELL POPULATIONS IN THE LUNG MICROENVIRONMENT TO DETERMINE IF THERE IS A MALIGNANCY PRESENT.
PHYSICANSTELL US CYPATH LUNG IS HELPFUL WITH PATIENTS WITH SMALL PULMONARY NODULES. THESE PATIENTS ARE OFTEN ASKED TO WAIT AND SEE IF THE NODULEGROWS. OR A PHYSICIAN MAY OPT FOR A MORE INVASIVE BIOPSY ONLY TO FIND THAT THE NODULE IS BENIGN. THE UNCERTAINTY IS STRESSFUL FOR BOTHTHE PHYSICIAN AND THE PATIENT. CYPATH LUNG DOES NOT REPLACE THE TOOLS A PHYSICIAN USES TO FIND EARLY CANCER, IT ENHANCES AND ADDS TOTHE TOOLBOX AND CAN BRING MORE CLARITY ON NEXT STEPS FOR BOTH PHYSICIANS AND THEIR PATIENTS.
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PHYSICIANSARE ALSO WELL AWARE OF THE COSTS TO PATIENTS AND FINANCIAL BURDEN OF HEALTHCARE. AND IN 2024, WE SAW THAT CYPATH LUNG HAS THE POTENTIALTO MAKE A SIGNIFICANT, POSITIVE DIFFERENCE.
EARLIERTHIS 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 PATIENTSWITH SMALL PULMONARY NODULES. THEY CONSIDERED THE COST OF FOLLOW-UP, BASED ON PUBLISHED DATA, AND THE SAVINGS IN ADDING CYPATH LUNG TOTHE CARE PATHWAY FOR PATIENTS ON MEDICARE, AND SEPARATELY LOOKED AT THE IMPACT OF USING CYPATH LUNG AS PART OF THE DIAGNOSTIC PATHWAYFOR 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 2022TO THE U.S. HEALTHCARE SYSTEM.
ANDFOR THOSE PATIENTS COVERED BY PRIVATE INSURANCE, THE STUDY REPORTED A SAVINGS OF MORE THAN $6,400 PER PATIENT WHICH WOULD HAVE RESULTEDIN NEARLY $900 MILLION IN TOTAL SAVINGS TO THE HEALTHCARE SYSTEM IF OUR TEST HAD BEEN USED WITH PATIENTS IN 2022 WHO HAD PULMONARY NODULESBETWEEN 6 TO LESS THAN 30 MILLIMETERS.
LETME 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’SLARGEST U.S. MILITARY HOSPITAL. HE IS A PULMONOLOGY AND CRITICAL CARE PHYSICIAN AND ASSISTANT DEAN OF RESEARCH AT THE SAN ANTONIO UNIFORMEDSERVICES HEALTH EDUCATION CONSORTIUM. DR. SHEILA A. HABIB IS DIRECTOR OF THE PULMONARY LUNG NODULE CLINIC AND THE LUNG CANCER SCREENINGPROGRAM AT THE SOUTH TEXAS VETERANS’ HEALTH CARE SYSTEMS’ AUDIE L. MURPHY MEMORIAL VETERANS HOSPITAL – THIS IS ONEOF OUR NATION’S LARGEST VA HOSPITAL SYSTEMS.
THESEARE PHYSICIANS WHO RECOGNIZE THE IMPORTANCE OF CYPATH LUNG. AND THERE ARE A GROWING NUMBER OF PHYSICIANS WHO SIMILARLY SEE THE BENEFITIN USING OUR NONINVASIVE TEST.
IN2025, WE WILL WORK WITH PHYSICIANS WHO ARE ADVOCATING ON OUR BEHALF, AND WE WILL TAKE WHAT WE HAVE LEARNED AND HOW WE HAVE IMPROVED THEPHYSICIAN AND PATIENT JOURNEY, AND WE WILL STRATEGICALLY EXPAND OUR MARKET. SOME OF OUR INVESTORS ON THE CALL WILL REMEMBER THAT WE MADEA 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 VERYBIG BACKYARD – IN FACT, BY OUR ASSESSMENT IT IS THE FIFTH LARGEST STATE FOR PULMONARY PRACTICES. THIS APPROACH PROVIDED US THEABILITY TO EVALUATE THE MARKET, HONE OUR MESSAGING, BUILD A SALES TEAM AND IMPROVE OPERATIONS.
2025WILL 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 EXISTINGPRACTICES WHO CAME TO US LARGELY BY WORD-OF-MOUTH FROM OTHER PHYSICIANS. THERE ARE ORDERING PHYSICIANS IN 15 STATES WHO LEARNED ABOUTCYPATH LUNG FROM A COLLEAGUE OR A PATIENT. WE BELIEVE THOSE ARE THE PRACTICE AREAS WORTH EXPANDING. BUT, OF COURSE, WE WON’T FORGETTEXAS, WHICH OFFERS FURTHER OPPORTUNITIES FOR GROWTH – BOTH IN INCREASED USE OF OUR TEST WITH EXISTING CLIENTS AND INCREASING OURCUSTOMER BASE.
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OFCOURSE, WE RECOGNIZE THAT A LARGER MARKET MEANS A GREATER MARKETING EFFORT. MARKETING PLAYS A CRITICAL ROLE IN SALES. WE ESTABLISHEDOUR BRAND WITH THE HELP OF HAVAS HEALTH, AND NOW WE WILL BE WORKING WITH AN EQUALLY WELL RESPECTED, HIGHLY INNOVATIVE MARKETING AGENCYWITH AN IMPRESSIVE PEDIGREE IN TAKING NEW PRODUCTS TO MARKET IN THE PULMONARY SPACE. IN ADDITION TO INCREASING OUR SALES TEAM, IN 2025WE LOOK TO HIRE A MARKETING DIRECTOR TO ADD EMPHASIS AND SUPPORT NEEDED TO INCREASE SALES.
INADDITION TO EXPANDING OUR SALES EFFORTS IN 2025, WE ALSO EXPECT TO INITIATE OUR CLINICAL STUDY NEXT YEAR. WE HAVE REPORTED THAT WE INTENDTO CONDUCT A CLINICAL TRIAL THAT WILL BE THE BASIS FOR SEEKING CLEARANCE OF CYPATH LUNG BY THE FOOD AND DRUG ADMINISTRATION – THEFDA. WE EXPECT TO BEGIN THIS LARGER CLINICAL TRIAL IN 2025, AND TOWARDS THAT END, WE MET THIS MONTH WITH THE FDA TO DISCUSS OUR TRIALDESIGN AND THE TEST’S INTENDED USE, AMONG OTHER TOPICS. WE WERE ENCOURAGED BY THE MEETING, AND WE WILL CONTINUE TO WORK WITH THEAGENCY AS WE MOVE FORWARD.
ASPART 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 AREINTERESTED IN TAKING PART IN THE STUDY. THESE VA MEDICAL CENTERS ARE IN VARIOUS STAGES OF QUALIFICATION, AND IT IS IMPORTANT TO UNDERSTANDTHAT SOME MAY NOT BE IN THE STUDY FOR VARIOUS REASONS. BUT WE ARE ENCOURAGED BY THE RESPONSE OF THESE PHYSICIANS WHO TREAT OUR VETERANPOPULATION AND SEE THE NEED TO ADVANCE CYPATH LUNG. IN ADDITION TO THE VA, WE ALSO HAVE A NUMBER OF LARGE PRIVATE AND ACADEMIC MEDICALCENTERS THAT ARE IN THE PROCESS OF BEING QUALIFIED AS COLLECTION SITES.
OURNATIONAL PRINCIPAL INVESTIGATOR FOR THIS TRIAL IS DR. MICHEAL MORRIS OF BROOKE ARMY MEDICAL HOSPITAL WHO I MENTIONED EARLIER. WE EXPECTSEVERAL 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 ENTHUSIASMFOR CYPATH LUNG.
ITMAY BE HELPFUL – IF JUST FOR A MOMENT I STEP BACK TO EXPLAIN THAT CYPATH LUNG IS – AT THIS TIME – A LABORATORY DEVELOPEDTEST. THAT MEANS THAT CYPATH LUNG IS SOLD BY A SINGLE LABORATORY – IN THIS CASE OUR SUBSIDIARY PRECISION PATHOLOGY – ANDAVAILABLE ONLY IF ORDERED BY A PHYSICIAN. THE CENTERS FOR MEDICARE AND MEDICAID OVERSEE LDTS LIKE CYPATH LUNG. AND A NEWLY PROMULGATEDRULE BY THE FDA RESULTS IN FDA HAVING GREATER JURISDICTION OVER LDTS, BUT I WOULD NOTE THAT OUR CYPATH LUNG TEST IS GRANDFATHERED UNDERTHE RULE. I AM EXPLAINING THIS BECAUSE THE RULES GOVERNING LABORATORY TESTS CAN BE CONFUSING. AND I ALSO WANT TO MAKE CLEAR THAT WE WILLCONTINUE TO MARKET CYPATH LUNG AS WE MOVE THROUGH THE FDA PROCESS. I HOPE THIS EXPLANATION IS HELPFUL.
ASPROUD AS WE ARE OF OUR ADVANCEMENT OF CYPATH LUNG, WE ARE WELL AWARE OF THE POTENTIAL OF OUR FLOW CYTOMETRY-BASED TECHNOLOGY. OUR RESEARCHTEAM IS LED BY DR. WILLIAM BAUTA WHO, DURING HIS TIME WORKING FOR ILEX AND GENZYME, PLAYED A KEY ROLE IN SUCCESSFULLY BRINGING NEW MEDICALPRODUCTS TO MARKET. WE HAVE DECIDED IN THE NEAR TERM TO FOCUS OUR RESEARCH EFFORTS IN DEVELOPING OUR TEST FOR COPD THAT WOULD HELP IDENTIFYPATIENTS EARLY ENOUGH TO TAKE ADVANTAGE OF THE NEW, VERY PROMISING COPD THERAPIES COMING ONTO THE MARKET. IN 2025, WE ALSO WILL BUILDON OUR WORK WITH COPD AND LOOK AT DEVELOPING DIAGNOSTICS FOR ASTHMA. WE VIEW THESE TESTS, WHICH ARE UNDER DEVELOPMENT, AS POSSIBLE COMPANIONOFFERINGS WITH CYPATH LUNG TO THE PULMONARY MARKET.
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BIOAFFINITYTECHNOLOGIES WAS BUILT ON INNOVATION, DEDICATION AND A BELIEF THAT WE CAN MAKE A DIFFERENCE, BOTH INDIVIDUALLY AND COLLECTIVELY. WE HAVEA STRONG MANAGEMENT TEAM, AND A HIGHLY EXPERIENCED BOARD OF DIRECTORS WHO PLAY A KEY ROLE IN OUR SUCCESS.
OUREXECUTIVE CHAIRMAN STEVE GIRGENTI IS A VETERAN HEALTHCARE EXECUTIVE WHO FOUNDED HEALTHWORLD, A GLOBAL HEALTHCARE MARKETING FIRM THATWAS, WHEN HE RAN IT, ONE OF THE LARGEST IN THE WORLD.
THECHAIRMAN OF OUR AUDIT COMMITTEE, STUART DIAMOND, IS THE GLOBAL CHIEF FINANCIAL OFFICER OF GROUP M, A MEDIA INVESTMENT MANAGEMENT GROUPWITH OVER $60 BILLION IN BILLINGS. OUR DIRECTOR DR. JAMIE PLATT HAS BEEN GUIDING TEAMS IN DEVELOPING, VALIDATING, AND COMMERCIALIZINGMORE THAN 40 INNOVATIVE, HIGH-COMPLEXITY TESTS FOR U.S. AND GLOBAL FIRMS. SHE SERVED AS CHIEF OPERATING OFFICER AT PGDx WHICHWAS ACQUIRED BY LABCORP AND INIVATA WHICH WAS ACQUIRED BY NEOGENOMICS FOR A COMBINED VALUE OF NEARLY $1 BILLION.
OURMANAGEMENT TEAM IS EQUALLY STRONG. OUR CFO, MICHAEL EDWARDS, GUIDED US THROUGH OUR IPO AND RECENTLY REJOINED THE COMPANY. HE HAS 30-PLUSYEARS IN CORPORATE FINANCE, INCLUDING SERVING AS CFO FOR BOTH PUBLIC AND PRIVATE COMPANIES. I’M VERY PROUD TO HAVE HIM AT MY SIDE.
OURCHIEF OPERATING OFFICER, XAVIER REVELES, BRINGS MORE THAN 25 YEARS OF EXPERIENCE AS A CLINICAL GENETICIST SKILLED IN THE CREATION ANDMANAGEMENT OF CLIA CLINICAL LABORATORIES, CODING AND REIMBURSEMENT VALUATIONS.
OURCHIEF SCIENCE OFFICER, BILL BAUTA WHO I MENTIONED EARLIER, WAS RESPONSIBLE FOR THE DISCOVERY, DEVELOPMENT, AND FDA APPROVAL OF MULTIPLEPRODUCTS DURING HIS TENURE AT GENZYME CORPORATION AND ILLEX PRODUCTS.
OURSALES TEAM IS LED BY DALLAS COLEMAN, WHO BRINGS MORE THAN 15 YEARS OF EXPERIENCE IN MEDICAL SALES WHERE HE SUCCEEDED IN LAUNCHING NEWPRODUCTS FOR OLYMPUS AMERICA’S THERAPEUTIC SOLUTIONS DIVISION, WORKING PRIMARILY WITH PULMONOLOGISTS, THORACIC SURGEONS AND PHYSICIANSTREATING PATIENTS WITH LUNG DISEASE. AND HE HAS BROUGHT HIS EXPERIENCE, HIS SKILL AND GOOD WILL TO BIOAFFINITY.
I’VESPENT MORE THAN 30 YEARS IN THE C-SUITE IN THE MEDICAL, ENVIRONMENTAL AND ENGINEERING FIELDS. I’VE HAD THE HONOR OF LEADING BIOAFFINITYFROM A SMALL STARTUP OF THREE PEOPLE TO A PUBLIC COMPANY WITH TALENTED AND EXPERIENCED EMPLOYEES AT EVERY LEVEL WHO ARE COMMITTED TOADVANCING CYPATH LUNG AND ITS PLATFORM. FOR ME, CYPATH LUNG IS ALSO A PERSONAL CALLING. MY FATHER, WHO WAS LITERALLY A ROCKET SCIENTIST– WHO WAS THE ONE TO PRESS THE BUTTON TO LAUNCH AMERICA’S FIRST INTERCONTINENTAL BALLISTIC MISSILE, WHO WAS A DECORATED WORLDWAR 2 VETERAN, A FATHER OF THREE, AND YES, A SMOKER, DIED OF LUNG CANCER AT AGE 39.
IAM DEDICATED, AS ARE THE PEOPLE WHO WORK AT BIOAFFINITY TECHNOLOGIES, TO BRINGING VALUE TO OUR SHAREHOLDERS BY BRINGING DIAGNOSTICS TOMARKET THAT HELP PEOPLE LIVE LONGER, HEALTHIER LIVES. IT IS OUR PROFESSION, BUT IT ALSO IS PERSONAL.
ANDON A PERSONAL NOTE, I WANT TO THANK YOU FOR LISTENING TODAY, AND FOR LEARNING MORE ABOUT OUR STRONG MANAGEMENT TEAM, STRONG RESEARCHTEAM, STRONG SALES TEAM AND OTHERS WHO ARE DEDICATED TO BRINGING VALUE TO OUR SHAREHOLDERS. WE ARE READY TO EXECUTE ON A PLAN IN 2025– AND BEYOND. WE ARE READY TO EXECUTE ON A PLAN THAT CAN INCREASE REVENUES, EXPAND OUR MARKET, ADVANCE NEW TESTS IN OUR PIPELINEAND CONDUCT OUR PIVOTAL TRIAL. WE REMAIN FOCUSED ON BRINGING SHAREHOLDER VALUE BY HELPING PHYSICIANS GIVE THEIR PATIENTS BETTER DIAGNOSTICSSO THEY CAN TAKE ADVANTAGE OF MORE TARGETED CARE THAT CAN LEAD TO LONGER, HEALTHIER LIVES.
THANKYOU FOR ATTENDING TODAY AND I AM HAPPY TO TAKE QUESTIONS.
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