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): September 26, 2019

PRECIPIO, INC.
(Exact Name of Registrant as Specified in Its Charter) 

 

 

 

 

 

Delaware
(State of Incorporation)

 

001-36439
(Commission File Number)

 

91-1789357
(I.R.S. Employer Identification No.)

 

4 Science Park, New Haven, CT 06511

(Address of principal executive offices) (Zip Code)

(203) 787-7888

(Registrant's telephone number, 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)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Ticker symbol(s)

Name of each exchange on which registered

Common Stock, $0.01 par value per share

PRPO

The Nasdaq Stock Market LLC

 

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 September 26, 2019, Precipio, Inc (the "Company") issued a press release with update regarding the Company’s clinical validation status being completed.  A copy of the letter is attached hereto as Exhibit 99.1 and 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

 

(d) Exhibits

99.1 Press Release dated September 26, 2019 

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:September 26, 2019 

 

 

 

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Clinical Validations for IV-Cell™ and HemeScreen™ Completed

 Orders expected from several major labs both domestically and internationally

 

NEW HAVEN, CT, (September 27, 2019) – Specialty diagnostics company Precipio, Inc.  (NASDAQ:  PRPO), announced that as it approaches the end of Q3-2019, several of the large laboratories have successfully completed validation studies to test Precipio’s  IV-Cell cytogenetics media product, as well as its HemeScreen Assay, and are proceeding towards placing orders.  

 

From Validation Testing To Revenue

 

As previously discussed, each lab must undergo a complex and thorough process to introduce products such as IV-Cell cytogenetics media and HemeScreen Assay into its clinical work-flow. This includes extensive testing as well as side-by-side comparison to the laboratory’s existing process in order to ensure both consistent results, as well as superior performance of the products. 

 

Each potential customer has their unique acceptance procedures. Only once these and other important parameters are demonstrated, does a laboratory proceed to discuss purchasing this product and integrating it into their clinical operations. 

 

“This process is no different than the process we at Precipio take when evaluating and introducing a new technology; after all, we are dealing with patients’ lives and the diagnosis of cancer, a task we take incredibly seriously. Therefore a rigorous process is expected to ensure accuracy of results” said Dr. Ayman Mohamed, Precipio’s Laboratory Scientific Director.

 

In the laboratories that have completed their clinical testing step, the next and final step is the agreement on commercial terms. Based on the size of the customer, this usually involves various approvals within the organizational hierarchy; followed by a pricing/volume discussion to establish the economic terms. Finally, the laboratory must evaluate its current inventory levels to assess the timeline to exhausting the inventory it has on hand of its current products (typically 30-60 days’ worth of inventory) and place an order accordingly. 

 

New Product Commercialization Efforts

 

Precipio management and its commercial team have been engaged in substantial efforts to commercialize its products, including in-roads into some of the largest laboratories both domestically and internationally. 

 

As with many new products, the first sale is always the most difficult one. Absent a product track record and prior customer references, the product introduction is challenging. However, the combination of the clinical value of products such as IV-Cell, combined with its operational and cost-advantage benefits, have proven extremely attractive to the customers approached by Precipio. 

 

Over the past six months the team has been focused on approaching customers and obtaining agreements for trials. As in all sales, this is very much a “shots on goal” approach, and the more

customers the company approaches, the more trials are conducted, the more end-user customers we project to have. 

 

The company has had substantial success (as measured by the response rates) and has a pipeline of numerous additional trials underway both domestically and internationally. 

 

As typically in new product launches, through frequent meetings and presentations to customers, the company continuously learns how to improve its product positioning and marketing message. We have also been able to identify the key benefits that are important to customers. That feeds into an improved message which ultimately increases the yield of sales efforts. 

 

The company's commercialization efforts internationally have enabled for trials that were successfully secured for IV-Cell, with revenue potential estimated at $5M annually. The seven trials were generated from a total of eight laboratories that were presented with the product.

 

“We are energized by the results of the commercialization of our products. I have witnessed firsthand our recent successes in generating interest, trials, and successful results for labs both in the US and overseas; this clearly demonstrates we have a product that combines clinical, operational and economic value to laboratories serving their patients”, said Ilan Danieli, Precipio’s Chief Executive Officer. “I have no doubt that proprietary technologies such as IV-Cell will be a substantial driver of revenue, gross margin, and profitability in the coming quarters - yes it takes longer time than anticipated but I am confident that we are on the right path forward to creating substantial shareholder value.” 

 

About Precipio

Precipio has built a platform designed to eradicate the problem of misdiagnosis by harnessing the intellect, expertise and technology developed within academic institutions and delivering quality diagnostic information to physicians and their patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment such as the Yale School of Medicine and Harvard’s Dana-Farber Cancer Institute, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com. 

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements,” within the meaning of federal securities laws, including statements related to ICP technology, including financial projections related thereto and potential market opportunity, plans and prospects and other statements containing the words “anticipate,” “intend,” “may,” “plan,” “predict,” “will,” “would,” “could,” “should,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the known risks, uncertainties and other factors described in the Company’s definitive proxy statement filed on April 19, 2019 , the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 and on the Annual Report on Form 10-K for the year ended December 31, 2018 as well as the Company’s prior filings and from time to time in the Company’s subsequent filings with the Securities and Exchange Commission. 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. All information in this press release is as of the date of the release and the Company does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Inquiries:

investors@precipiodx.com

+1-203-787-7888