8-K
Precipio, Inc. (PRPO)
UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
FORM 8-K
CURRENT REPORTPURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGEACT OF 1934
Date of report (Date of earliest event reported):
August 18, 2025
PRECIPIO,
INC. (Exact Name of Registrant as Specified in Its Charter)
| Delaware | 001-36439 | 91-1789357 |
|---|---|---|
| (State of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
4 Science Park, New Haven,CT 06511
(Address of principalexecutive offices) (Zip Code)
(203) 787-7888
(Registrant's telephonenumber, including area code)
Not
Applicable (Former name, former address and former fiscal year, if changed since last report date)
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 communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
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| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
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| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
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| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |
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| Securities registered pursuant to Section 12(b) of the Act: | ||
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| Title of each class | Ticker symbol(s) | Name of each exchange on which<br><br>registered |
| Common Stock, $0.01 par value per share | PRPO | Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company ¨
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 |
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On August 18, 2025, Precipio Inc posted an updated version of its investor presentation on the Company’s investor relations website at https://www.precipiodx.com/wp-content/uploads/2025/08/prpodeck2025.pdf. The updated investor presentation supersedes the version furnished on June 13, 2022. A copy of the updated presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed subject to the requirements of amended Item 10 of Regulation S-K, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
| Item 9.01 | Financial Statements and Exhibits |
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(d) Exhibits
| 99.1 | Investor Presentation, dated August 18, 2025 |
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| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| PRECIPIO, INC. | |
|---|---|
| By: | s/ Ilan Danieli |
| Name: | Ilan Danieli |
| Title: | Chief Executive Officer |
Date: August 18, 2025
Exhibit 99.1
| Diagnostics Biotech Company<br>NASDAQ: PRPO<br>Founded in 2011<br>HQ: New Haven, CT<br>DISCLAIM ER<br>T HIS PRESENT AT ION HAS BEE N PREPARE D B Y P RE CIPIO IN C. (T HE “C O MPAN Y”) AND IS GENERA L BA CKGROUND IN FOR MAT I ON ABOUT T HE C O MPAN Y’S ACT IV IT IES AS O F T HE DAT E O F T HIS PRESENT AT ION . B Y AC CEPT ING T H IS PRESENT AT ION , T HE RE CIPIENT ACKNOW LEDGES AND AG REES T HAT A LL OF T HE IN FOR MAT ION CONT A INED<br>HEREIN IS CO N FIDENT IA L, T HAT T HE RECIP IENT W IL L DIST R IBUT E , D ISC LOSE , AND U SE SUCH IN FOR MAT ION ON L Y FOR SUCH PU RPOSE AND T HAT T HE RECIP IENT SHA L L N OT D IST RIBUT E, D ISC LOSE OR USE SUCH IN FOR MAT IO N IN AN Y W AY DET RI MENT AL T O T HE C O MPAN Y. T HE IN FOR MAT IO N CONT A IN ED HEREIN DOES NOT PURP OR T<br>T O BE A L L INC LUS IVE AN D T HE CO MPAN Y NOR AN Y O F IT S RESPE CT IVE A F FI L IAT ES N OR AN Y O F IT S OR T HE IR CONT RO L L ING PERSONS , O F F ICERS , DIRECT ORS , E MP LO YEES OR REP RESENT AT IVE S MAKES AN Y REP RESENT AT I ON O R W ARRANT Y, E XP RESS OR I MP L IED , AS T O T HE ACCURA C Y, CO MP L ET ENESS OR RE LIAB I LIT Y O F T H E<br>IN FOR MAT ION CONT AI NED I N T HI S PRESENT AT IO N . T H IS PRESENT AT ION D OES NOT CONT A IN A L L T HE IN FOR MAT IO N T HAT IS OR MA Y BE MAT ERIA L T O INVEST O RS OR P OT ENT IA L INVEST OR S AND SHOU LD NOT BE CONS IDERED AS ADVICE OR A RECO MMENDAT ION T O IN VEST ORS OR POT ENT IA L INVEST ORS IN RE SPECT O F T HE<br>HOLD ING , PURCHA SING OR SE L LI NG O F SEC URIT I ES OR OT HER F INANC IA L INST RU MENT S AND DOE S NOT T AKE INT O ACC OUNT AN Y INVEST OR ’S PAR T ICU LAR OBJECT IVES, FINAN CIA L S IT UAT ION OR N EEDS. CERT A IN ST AT E MENT S I N T HIS PRESENT AT I ON MA Y CON ST IT UT E “ FORW ARD-LOOK ING ST AT E MENT S ” W IT HIN T HE MEAN ING O F<br>SECT ION 2 7A O F T HE SECUR IT IES ACT O F 1 93 3 , A S A MEN DED, AND SE CT ION 2 1E O F T HE SE CURIT IE S E XCHAN GE ACT O F 1 9 34 , AS A MEN DED, W HICH I NVOLVE KN OW N AND U NKNOW N RISKS , UNCERT A I NT IES AND OT HER FACT ORS T HAT MA Y CA USE AC T UAL RESU LT S T O B E MAT ER IAL L Y DI F FERENT FR OM A N Y ANT IC IPAT ED / FORECAST E D<br>RESULT S , PER FO R MANCE OR ACH IEVE MENT S E XPRESSED OR I MP L IED B Y SUC H ST AT E MENT S. F ORW ARD-LOOK ING ST AT E MENT S I NC LUDE, BUT ARE NOT LI MIT ED T O, T HOSE W IT H RESPECT T O MANAGE ME NT ’S C URRENT V IEW S AND EST I MA T ES OF FUT URE EC ONO MIC C IRCU MST A NCES, I NDUST R Y COND IT I ONS, CO MPAN Y<br>PERFO R MANCE , F INANC IA L RESU LT S , INC LUD ING T HE ABI L IT Y O F T HE CO MPAN Y T O INCREA SE IT S PRESENCE /I MPA CT / MA RKET SHAR E IN T HE DIA G NOST IC PRODUCT S AND SERVICES MARKET S, AN D REGU LAT OR Y MAT T ERS. T HE SE FORW ARD-LOO KING ST AT E MENT S A RE BASED UPON EST I MAT ES AND ASSU MPT IO NS T HAT , W HILE<br>CONSIDERED REASON ABL E B Y T HE CO MPAN Y AN D IT S MANAGE ME NT , AS T HE CASE MA Y BE , ARE IN HERENT L Y UNCERT A IN . NEW RISKS AND UNCERT AI NT IES MA Y E MER GE FRO M T I ME T O T I ME, AND IT I S NOT POS SIB LE T O PRED ICT AL L RI SKS AND UNC ERT AINT IES. T HE KNOW N RISKS, UNC ERT AINT IES AND OT HER FACT ORS A F FECT IN G<br>T HESE F ORW ARD-LOOK ING ST AT E MENT S A RE DES CRIBED FR O M T I ME T O T I ME IN T HE CO MPAN Y’S F I LI NGS W IT H T HE SECUR IT IES AND E XCHA NGE CO M MISSI ON, INC LUD ING T HE CO MPAN Y’S MOST RE CE NT ANNUA L REPORT ON FO R M 1 0-Q AND 1 0 -K. AN Y CHANGE IN SUCH FACT ORS , R ISKS AND U NCERT A INT IES MA Y CAUSE T HE ACT UA L<br>RESULT S , EVENT S AND PE R FOR MAN CE T O DI F FE R MAT ER IA L L Y FRO M T HOSE RE FERRE D T O IN SUC H ST AT E MENT S. FACT ORS T HAT MA Y C AUSE ACT U AL RESU LT S T O DI F FER MAT ERI AL L Y F RO M CUR R ENT E XPECT AT IONS INC LUDE , BUT ARE NOT LI MIT ED T O , VAR IOUS FACT ORS BE YOND MANAGE ME NT ’ S CO NT RO L IN C LUDIN G GENERA L<br>ECONO MIC COND IT IO NS AND OT HER R ISKS , AS W ELL AS FACT ORS ASSOC IAT ED W IT H CO MPANIE S, SUCH AS PREC IPI O, T HAT ARE EN GAGED IN D IAGNOST ICS AND OT HER RESEARCH AND DEVE L OP MENT ACT IV IT IE S IN T HE B IOT ECHN OL OG Y IN DUST RY, I NC LUDI NG UNCERT A INT Y I N P RODUCT ACCEPT ANCE AND/ OR RECE IPT O F<br>REGULAT OR Y APPROVA LS FOR PRODUCT CAND ID AT ES, INC LUD ING AN Y DE LA YS A ND OT HER I MPA CT S FRO M T HE COV ID 1 9 PANDE MIC . A CCORD ING L Y, T HE CO MPAN Y CLA I MS T HE PROT ECT ION O F T HE SA FE HARBOR FOR FORW ARD-LOOKIN G ST AT EMENT S CO NT AINED IN T HE SEC URIT IES A CT W ITH RESPECT T O A LL ST AT E MENT S<br>CONT AINED IN T HIS PR ESENT AT I ON. A LL IN FOR MA T ION IN T H IS PRESENT AT ION IS AS O F T HE DAT E W HEN T HIS PRESENT AT ION W AS PROVIDED T O T H E RECIP IENT B Y PR ECIP IO AND PREC IPIO DOES N OT UNDERT AKE AN Y DUT Y T O UPDAT E T H IS IN FOR MAT ION , INC LUDI NG AN Y FORW ARD-LO OKING ST A T EMENT S, U NLESS REQU IRED B Y<br>LAW . NO REP RESENT AT I ON OR W ARRANT Y, E XPR ESS OR I MP LIED, IS MA DE AS T O T HE FA IRNESS , ACCURAC Y OR CO MP LET ENESS O F T HE P RESENT AT ION AND T HE IN FOR MAT IO N CONT A INED HERE I N AND NO RE LIA NCE SHOU LD BE P LACE D ON IT . I NFOR MAT I ON IN T H IS PRESENT AT ION ( INC LUDI NG MARK ET DAT A AND ST AT IST ICA L<br>IN FOR MAT ION ) H AS BEEN OBT A INED FRO M VARI O US SOURCES (INC LU DING T H IRD-PART Y S OURCES) AND T HE CO MPA N Y DOE S NOT GUARA NT EE T HE ACCURAC Y OR CO MP LET EN ESS O F SUCH IN F OR MAT ION . W HILE T HE CO MPAN Y BE LIEVE S IT S INT ERNAL RESEARCH IS RE L IAB LE, SUCH RESEARCH HAS N OT BEEN VER I FIED B Y AN Y<br>INDEPENDENT SOURCE. A L L PROJECT IONS, VA LUA T IONS AN D ST AT IST ICA L ANA L YSES A RE PROV IDE D FOR IN FOR MAT ION PURPOS ES ON L Y. T HE CONT ENT S O F T H IS P RESENT AT I ON SHO U LD NOT BE C ONSIDERED T O B E LEGA L , T A X, INVEST MENT OR OT HER ADV ICE, AND AN Y INVEST OR OR PROSPEC T IVE INVEST OR CONS IDER ING T H E<br>PURCHASE O R D ISPOSA L O F AN Y SEC URIT IES O F T HE C O MPAN Y SHOU LD CONS ULT W IT H IT S OW N COUNSE L AND ADVISE RS AS T O A L L LEGA L , T A X, REG UL AT OR Y, F INANCI AL AND RE LAT ED MAT T E RS CONCER NING AN INVEST MENT IN OR DISP OSA L O F SUC H SECU RIT IES AN D AS T O T HEIR SU IT A BIL IT Y FOR SUCH INVEST O R OR<br>PROSPECT IVE I NVEST OR T HIS PRESE NT AT IO N AN D IT S CO NT ENT S ARE CON FI DENT IA L AND PROPR I ET ARY T O T HE CO MPA N Y, AND NO PART O F IT OR IT S SUBJECT MAT T ER MA Y BE REP RODUCED , REDI ST RIBUT ED , PASSE D ON, OR T HE CONT ENT S OT HE RW ISE DIVU LGED , D IRECT L Y OR I NDIRE CT L Y, T O ANY OT HER PERS ON (E XC LUD ING<br>T HE RELEVANT PERSON’S PROFESSIONAL ADVISERS) OR PUBLISHED IN W HOLE OR IN PART FOR ANY PURPOSE W IT HOUT T HE PRIOR W RIT T EN CONSENT OF T HE COMPANY. |
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| We develop products that save lives<br>2<br>Acute Myeloid Leukemia (AML) is one of the deadliest forms of cancer.<br>Physicians treating patients with AML face two unsuitable options.<br>Precipio’s assay enables immediate, targeted treatment - SAVING LIVES<br>Patient diagnosed with AML<br>Molecular tests ordered<br>(10-15 day wait)<br>Consequence: potentially inadequate<br>treatment; targeted therapy options eliminated<br>Begin Standard Chemo;<br>(Don’t wait for molecular results)<br>OPTION<br>1<br>Consequence: patient’s life at<br>risk due to treatment delay<br>Wait 10-15 days for<br>Molecular Results<br>OPTION<br>2<br>vs<br>4-hour Rapid<br>AML test<br>All treatment options<br>available DAY 1 |
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| 3<br>Precipio is eliminating ineffective diagnosis<br>We eliminate both misdiagnosis and diagnostic delays, where outcomes depend on speed and accuracy.<br>of blood cancer diagnoses<br>are incorrect<br>25-40%*<br>diagnostic errors cost US<br>healthcare annually<br>10+ $100B**<br>days generally accepted<br>industry turnaround times in<br>molecular testing<br>* Journal of Clinical Oncology: Errors in Cancer Diagnosis. June 2007<br>American Society of Clinical Oncology: Second-opinion pathologic review, July 2014<br>** American Medical Association: Diagnostic error in medicine. Nov 2009 |
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| We’ve built an innovative product development<br>platform, creating an unfair advantage<br>Our Unfair<br>Advantage<br>We are the first customer of<br>every product we develop<br>Our hands-on experience is<br>translated to our customers<br>We develop products in a<br>rapid, cost-effective manner<br>Pathology<br>Service Lab<br>Facilities, equipment<br> & talent<br>Patient samples arriving<br>daily<br>Exceptional clinical team<br>Foundation<br>4<br>Diagnostics<br>Product Division<br>R & D<br>Unsolved diagnostic<br>problems drive innovative<br>products<br>Leveraging clinical laboratory<br>to achieve cost-effective, rapid<br>product development |
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| Our profitable clinical lab business fully funds<br>R&D, significantly de-risking the company<br> ▪ Identifies market needs<br> ▪ Provides infrastructure<br>and patient samples<br>R&D Platform<br>Clinical Lab<br> ▪ Leverages infrastructure<br> & samples for rapid<br>product development<br>Example:<br>Precipio’s<br>BCR-ABL1<br>assay<br>1. Most advanced assay in market<br>2. Development time: 3 months<br>3. Development cost: <$100K<br>Product<br>Release<br>5 |
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| 6<br>We deliver testing options not available before<br>Our products address the key challenges laboratories face: Staff shortage, Capital budgets, and the ability to<br>deliver timely results<br>Factor Competition Precipio Solution Impact<br>Workflow Complex Simple Simplified workflow enables streamlined<br>process, fewer errors, and faster results<br>Labor Skill High Low Lower labor costs; Easier recruiting, training and<br>management of lab staff;<br>Capital Equipment > $1,000,000 < $25,000 Lower economic adoption threshold<br>Gross Margins 10–15% > 50% Attractive, contributing economics<br>Results Delivery 1 – 3 weeks 1 – 3 days Better patient care |
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| We scale through national distribution partner<br>agreements already in place<br>Go-to-market efficiency through leading channel partners, with nationwide reach<br>7<br>POL* Hospital /<br>Academic<br>Reference<br>Lab<br>* Physician-Owned Laboratory |
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| Blood cancers are just the beginning:<br>Expanding into a $40B+ market<br>* Transparency Market Research Onco-Hematology Molecular Market Testing June 2023<br>** BioSpace Molecular Diagnostic Market Size Report Aug 2024<br>Our technology is platform-ready to expand beyond hematology into broader cancer and molecular testing.<br>8<br>10% Other<br>cancers<br>87%<br>Other<br>Molecular<br>Diagnostics<br>PRESENT:<br>Blood Cancer Genetics<br>TAM: $500M*<br>LONG TERM:<br>Molecular Diagnostics<br>80%<br>Other<br>Cancers<br>20%<br>Blood<br>Cancers<br>NEAR TERM:<br>Cancer Genetics<br>TAM $6.7B** TAM $43B**<br>2025<br>2027<br>2030<br>2.5% blood<br>cancers |
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| Recurring revenue growth, high-margin outlook<br>0%<br>20%<br>40%<br>60%<br>80%<br>100%<br>Current Short term Long term<br>Revenue mix Products<br>Path services<br>0%<br>20%<br>40%<br>60%<br>80%<br>100%<br>Current Short term Long term<br> Path Services<br> Products<br> Blended<br>Gross Margin Analysis<br>As we scale products and alter the revenue mix, gross margins increase dramatically.<br>9 |
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| Proven leadership with deep clinical<br>and commercial experience<br>Ilan Danieli CEO<br>Ilan Danieli<br>CEO<br>Dr. Ayman Mohamed CTO<br>Dr. Ayman Mohamed<br>CTO<br>Zaki Sabet COO<br>Zaki Sabet<br>COO<br>Miri Radomski CPO Legal Counsel<br>Miri Radomski<br>CPO & Legal<br>Counsel<br>Stephen Miller CCO<br>Stephen Miller<br>CCO<br>Matt Gage CFO<br>Matt Gage<br>CFO<br>10 |
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| Precipio: A high-margin, proprietary diagnostics<br>platform with massive upside<br>Disruptive, Proprietary Products Rooted in solutions to<br>real-world diagnostic and monitoring challenges 1<br>Unique Development Platform - rapid and<br>capital efficient 2<br>3<br>Massive Market Opportunity – growing from<br>$0.5B TAM to multi billion-dollar markets in the future<br>4<br>Scalable, cost-efficient Go-To-Market with broad<br>coverage distribution model<br>5<br>Attractive Business Model – recurring, high margin<br>revenues and a Cash flow positive business<br>11 |
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| Thank you.<br>Please contact us at investors@precipiodx.com<br>20250817 |
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