8-K
Precipio, Inc. (PRPO)
8-K
2022-06-13
For: 2022-06-13
View Original
Added on
April 06, 2026
UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549
FORM 8-K
CURRENT REPORTPURSUANT TO SECTION 13 OR 15(d) OF THESECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported):
June 13, 2022
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 principal executive offices) (ZipCode)
(203) 787-7888
(Registrant's telephone number, including areacode)
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 | The 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
On June 13, 2022, Precipio Inc. (the “Company”) posted an investor presentation to its website at https://www.precipiodx.com/investors/assets/uploads/Precipio%202022%20Corp%20Presentation.pdf
A copy of the investor presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.
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
(d) Exhibits
| 99.1 | Precipio Investor Presentation |
|---|---|
| 104 | Cover Page Interactive Data File (cover page XBRL tags are 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: June 13, 2022
Exhibit 99.1
| Page<br>(NASDAQ: PRPO)<br>A Cancer Diagnostics Solutions Company<br>2022 Corporate Presentation<br>DISCLAIMER<br>This presentation has been prepared by Precipio Inc.(the “Company”) and is general background information about the Company’s activities as of the date of this presentation. By accepting this presentation, the recipient acknowledges and agrees that all of the information contained herein is confidential, that the recipient will distribute, disclose, and use such information only for such purpose and that the recipient shall not distribute, disclose or use<br>such information in any way detrimental to the Company. The information contained herein does not purport to be all inclusive and the Company nor any of its respective affiliates nor any of its or their controlling persons, officers, directors, employees or representatives makes any representation or warranty, express or implied, as to the accuracy, completeness or reliability of the information contained in this presentation. This presentation does not<br>contain all the information that is or may be material to investors or potential investors and should not be considered as advice or a recommendation to investors or potential investors in respect of the holding, purchasing or selling of securities or other financial instruments and does not take into account any investor’s particular objectives, financial situation or needs. Certain statements in this presentation may constitute “forward-looking<br>statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any anticipated/forecasted results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not<br>limited to, those with respect to management’s current views and estimates of future economic circumstances, industry conditions, company performance, financial results, including the ability of the company to increase its presence/impact/market share in the diagnostic products and services markets, and regulatory matters. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by the<br>Company and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in the Company’s filings with the Securities and Exchange Commission, including the Company’s most recent Annual Report on<br>Form 10-Q and 10-K. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, as well as factors associated with companies,<br>such as Precipio, that are engaged in diagnostics and other research and development activities in the biotechnology industry, including uncertainty in product acceptance and/or receipt of regulatory approvals for product candidates, including any delays and other impacts from the COVID 19 pandemic. Accordingly, the Company claims the protection of the safe harbour for forward-looking statements contained in the Securities Act with respect to all<br>statements contained in this presentation. All information in this presentation is as of the date when this presentation was provided to the recipient by Precipio and Precipio does not undertake any duty to update this information, including any forward-looking statements, unless required by law. No representation or warranty, express or implied, is made as to the fairness, accuracy or completeness of the presentation and the information contained<br>herein and no reliance should be placed on it. Information in this presentation (including market data and statistical information) has been obtained from various sources (including third-party sources) and the Company does not guarantee the accuracy or completeness of such information. While the Company believes its internal research is reliable, such research has not been verified by any independent source. All projections, valuations and<br>statistical analyses are provided for information purposes only. The contents of this presentation should not be considered to be legal, tax, investment or other advice, and any investor or prospective investor considering the purchase or disposal of any securities of the Company should consult with its own counsel and advisers as to all legal, tax, regulatory, financial and related matters concerning an investment in or disposal of such securities and as to<br>their suitability for such investor or prospective investor This presentation and its contents are confidential and proprietary to the Company, and no part of it or its subject matter may be reproduced, redistributed, passed on, or the contents otherwise divulged, directly or indirectly, to any other person (excluding the relevant person’s professional advisers) or published in whole or in part for any purpose without the prior written consent of the Company.<br>1<br>Rev. 2022<br>-<br>06 |
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| Page<br>Market problem<br>Diagnostic errors cost $750B*<br>annually in the US market<br>* Patient Safety Learning White paper publication by PinnacleCare<br>And countless lives.<br>2 |
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| Page<br>Company Vision<br>Creating clinically significant,<br>cost-effective cancer diagnostic<br>technologies to eliminate<br>laboratory errors<br>3 |
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| Page<br>Unique Business Model<br>Solving Clinical, Operational, & Economic Challenges for Diagnostic Laboratories<br> • Precipio identifies clinical and<br>operational challenges<br> • Facilitates the development,<br>testing and implementations<br>of new technologies<br>Clinical Laboratory<br> • Collaborates with the<br>clinical laboratory<br> • Develop & test new<br>technologies clinically and<br>operationally in the lab<br>Product<br>commercializati<br>on<br>R&D<br>Product Product Product<br>Commercialization Commercialization Commercialization<br>4<br>Pipeline |
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| Page<br>Solution<br>A set of proprietary<br>reagents using a<br>single-platform,<br>delivering faster and<br>more accurate<br>results<br>TAM<br>$500M in the US<br>$1B worldwide<br>Commercial status<br>5 commercial panels<br>3 panels in development<br>YE2021 RR: ~$2M<br>est. 25% QoQ growth<br>Hemescreen™ - Molecular Assays solving economic, workflow, & accuracy deficiencies<br>(patent pending)<br>5 |
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| Page<br>18 days TAT (send-out) reduced to<br>1-2 days (in house)<br>Broad panel enables more precise, targeted treatments<br>Shorter TAT drives a faster response and better patient care<br>Zero revenues, to ~$1M/year in operating profit<br>(currently one panel only)<br>HemeScreen Benefits<br>Turnaround Time (TAT)<br>Patient Impact<br>Customer Economics<br>HemeScreen delivered benefits to a large customer in Florida<br>Case Study<br>6 |
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| Page<br>Solution<br>A proprietary media (chemical)<br>used to simultaneously culture<br>multiple types of suspected<br>cancer cells, eliminating<br>diagnostic errors due to pre-<br>selection<br>TAM<br>$100M in the US<br>$250M worldwide<br>Commercial status<br>Products for hematologic cancers<br>available. Products for prenatal<br>testing under development.<br>Media is commercial and being<br>used by several laboratories<br>2022 RR: < $1M<br>IV-Cell™ Cytogenetics Cell Culture Media<br>7<br>Delivering improved accuracy, operational simplicity and cost benefit |
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| Page<br>Channel Distribution Strategy<br>Leveraging existing channel distributors<br>HemeScreen Segments:<br>Benefits:<br>Rapid direct access to target market Reduces time to market Avoids costly sales team<br>IV-Cell Segments:<br>90% 10%<br>TAM:<br>$100M US<br>$250M Globally<br>Physician owned laboratories<br>Reference laboratories<br>Hospital laboratories Academic center laboratories<br>Reference laboratories<br>25%<br>5% 70%<br>TAM:<br>$500M US<br>$1B Globally<br>8 |
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| Page<br>A novel technology enabling accurate assessment<br>of Minimal Residual Disease on limited samples<br>$3B Annually<br>In process – expected completion Q2-2023<br>Product 4: Cancer MRD<br>Enriches target DNA in samples to<br>significantly reduce biopsy rejection rate<br>$0.5B Annually<br>In process – expected completion Q1-2023<br>Product 3: QNS<br>Product<br>description<br>TAM<br>Development<br>Status<br>R&D Product Pipeline<br>2 examples<br>Clinical Lab R&D<br>9 |
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| Page<br>Having served as co-founder and CEO since 2011, Ilan brings over 25 years of<br>experience managing small and medium-size companies. Past experiences<br>include COO of Osiris, VP of Operations at Laurus Capital Management, a multi<br>billion-dollar hedge fund, as well as in various other entrepreneurial ventures.<br>Ilan Danieli, Chief Executive Officer<br>Matt was appointed to Interim Chief Financial Officer of Precipio, Inc. in March<br>2022. He served as Director of Financial Reporting and Analysis of Precipio, Inc.<br>since joining the Company in June 2017 following its acquisition of<br>Transgenomic Inc., where Matt was the Director of Financial Reporting and<br>Analysis since 2014. Matt has over 30 years of experience in corporate finance<br>for private and public companies.<br>Matt Gage, Interim Chief Financial Officer<br>As co-founder of Precipio, Ayman currently serves as the company CTO, as well<br>as the laboratory’s Technical Director. In this dual role, Ayman is responsible for<br>the entire process from conceptualization and invention of proprietary<br>technologies for Precipio. Prior to Precipio, Ayman served in various technical<br>and research positions in both commercial diagnostic companies as well as<br>academic centers such as Columbia and Yale Universities.<br>Ayman Mohamed, MD, Chief Technology Officer<br>Zaki has been the Company’s Chief Operating Officer since inception as its co-<br>founder. He holds over 15 years of experience in laboratory management spanning<br>all fields of reference laboratory operations primarily focusing on cancer diagnostics.<br>Prior to Precipio, Zaki has served as a consultant with the College of American<br>Pathologists (CAP) for many years as well as several diagnostic companies in setting<br>up their specialized cancer testing operations.<br>Ahmed Zaki Sabet, Chief Operating Officer<br>Keith Meadors has 38+ years of sales, marketing, leadership, and laboratory<br>diagnostics experience. Previously, Keith was VP of Sales & Marketing at Fresenius<br>Kabi and held several roles at Hospira and Becton Dickinson Diagnostics. Keith has an<br>MBA from Texas Christian University and has completed Medical Technology training<br>at Rex Hospital School of Medical Technology. He holds Executive Certificates in<br>Leadership, Sales, & Marketing Management from Kellogg and is ASCP Board Certified.<br>Keith Meadors, Sr. VP of Products Division<br>Miri is an advocate with extensive international legal experience from Sweden,<br>England and Israel specializing in advising on equity capital markets matters,<br>general corporate matters, corporate restructurings, corporate governance, day-to-<br>day securities law and company law issues and M&A transactions.<br>Miri Chiko-Radomski, Legal Counsel, Chief People Officer<br>Management Team<br>10 |
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| Page<br>Richard is a seasoned diagnostics executive with a substantial track record in<br>field. Having served and acted in multiple roles at Dianon Systems, Inc., a<br>diagnostics company that was acquired by LabCorp for $650M, along with Oxford<br>Immunotec, acquired by PerkinElmer for $550M, his depth and expertise is a<br>tremendous value to the Precipio team.<br>Richard Sandberg, Chairman of the Board<br>Jeffrey is a Hematopathologist and former Chair of Pathology Department at<br>Georgetown University. He was the CEO and Chairman at United States Diagnostics<br>Standard Inc. and is a co-founder of the Association for Molecular Pathology<br>(AMP). His career path includes: CSO and director of The Critical Path Institute,<br>Medical Director of Gene Logic, Inc. He also served as Senior Investigator in<br>Hematopathology at the National Cancer Institute. He is currently a medical<br>advisor to Epigenomics AG.<br>Jeffrey Cossman, MD, Director<br>Doug is currently a Partner at Revelation Partners, and joined the healthcare team<br>focusing on biopharmaceutical, diagnostic & medical device investments for<br>InterWest Partners, a venture capital firm. Doug served as Vice President of New<br>Leaf Venture Partners LLC, a private equity and venture capital firm, and prior to<br>joining New Leaf, he was a project leader with The Boston Consulting Group, Inc.,<br>where he was a member of the Health Care Practice Area.<br>Douglas Fisher, MD, Director<br>Ronnie is a seasoned diagnostics executive who is currently CEO of Oncocyte<br>(NASDAQ: OCX). Ronnie brings a wealth of experience in the diagnostics world,<br>and specifically in the areas of product development & commercialization. Some of<br>his past experiences includes CMO at Roche Molecular; President of Genetic<br>Science Division at Thermo Fisher Scientific; President of the Medical Sciences<br>Venture at Life Technologies Corporation; and CEO of Clarient, which was<br>acquired by GE Healthcare for $580M in 2010.<br>Ronald Andrews, Director<br>Kathy brings over 30 years of experience as a venture and angel investor and<br>builder of healthcare technology companies. She has extensive Board experience<br>and currently serves on the Boards of Bolt Biotherapeutics (NASDAQ: BOLT), and<br>Phoenix Biotech Acquisition Corporation (NASDAQ: PBAXU). Additionally, she has<br>served on multiple boards including Onyx Pharmaceuticals (NASDAQ: ONXX),<br>Affymax (NASDAQ: AFFY), and ISTA Pharmaceuticals (NASDAQ: ISTA).<br>Kathy Laporte, Director<br>David is currently the EVP and co-owner of Standard Oil of Connecticut, Inc., the<br>largest independently-owned energy retailing company in Connecticut. David has<br>also founded a number of highly successful ventures, including My Gene Counsel, a<br>cancer bioinformatics company. David currently serves on the boards of the<br>following companies: eBrevia, Emme Controls, My Gene Counsel, Sirona Medical<br>Technologies, and The Platt & LaBonia Company.<br>David Cohen, Director<br>Board Of Directors<br>11 |
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| Page<br>Established R&D<br>platform to develop<br>practical, efficient<br>diagnostic solutions<br>Two commercially<br>available, revenue<br>generating products<br>Robust R&D pipeline<br>of impactful cancer<br>diagnostic products,<br>each with billion<br>dollar TAMs<br>Revenue-generating<br>clinical lab creates a<br>self-funded R&D<br>center<br>For more information please contact:<br>Ilan Danieli, CEO<br>Precipio, Inc. (NASDAQ: PRPO)<br>idanieli@precipiodx.com<br>Tel: 203.787.7888 ex. 536<br>Summary<br>12 |
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