0001493152-17-010760.txt : 20170920 0001493152-17-010760.hdr.sgml : 20170920 20170920092756 ACCESSION NUMBER: 0001493152-17-010760 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20170918 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170920 DATE AS OF CHANGE: 20170920 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Interpace Diagnostics Group, Inc. CENTRAL INDEX KEY: 0001054102 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 222919486 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24249 FILM NUMBER: 171093368 BUSINESS ADDRESS: STREET 1: MORRIS CORPORATE CENTER 1, STREET 2: BUILDING C, 300 INTERPACE PARKWAY CITY: PARSIPPANY STATE: NJ ZIP: 07054 BUSINESS PHONE: 412-224-6100 MAIL ADDRESS: STREET 1: MORRIS CORPORATE CENTER 1, STREET 2: BUILDING C, 300 INTERPACE PARKWAY CITY: PARSIPPANY STATE: NJ ZIP: 07054 FORMER COMPANY: FORMER CONFORMED NAME: PDI INC DATE OF NAME CHANGE: 20021113 FORMER COMPANY: FORMER CONFORMED NAME: PROFESSIONAL DETAILING INC DATE OF NAME CHANGE: 19980129 8-K 1 form8-k.htm

 

 

 

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 18, 2017

 

 

 

Interpace Diagnostics Group, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-24249   22-2919486
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

Morris Corporate Center 1, Building C

300 Interpace Parkway

Parsippany, NJ 07054

(Address, including zip code, of Principal Executive Offices)

 

(855) 776-6419

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

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:

 

[  ] 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)) 

 

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 [  ]

 

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.

 

Attached hereto as Exhibit 99.1 is a copy of the Interpace Diagnostics Group, Inc. (the “Company”) press release dated September 20, 2017 related to written notice received from the Listing Qualifications department of The NASDAQ Capital Market. The information furnished in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.

 

Item 8.01. Other Events

 

On September 18, 2017, the Company received written notice (the “Letter”) from the Listing Qualifications department (the “Staff”) of The NASDAQ Capital Market notifying the Company that the Staff has determined that since the Company has appointed Dr. Felice Schnoll-Sussman to its Board of Directors and audit committee, it has regained compliance with Listing Rule 5605(c)(2). The Letter also stated that the matter related to Listing Rule 5605(c)(2), previously disclosed by the Company in its Current Report on Form 8-K filed October 13, 2016, has been closed.

 

The foregoing description is qualified in its entirety by reference to the full text of the Letter, which is filed as an exhibit to this Current Report on Form 8-K and incorporated herein by reference in its entirety.

 

Item 9.01. Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit Number   Description
99.1   Press Release dated September 20, 2017 (furnished pursuant to Item 7.01).
99.2   Written Notice, dated September 18, 2017, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (filed herewith pursuant to Item 8.01).

 

 

 

 

SIGNATURES

 

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.

 

  Interpace Diagnostics Group, Inc.  
   
Date: September 20, 2017 By: /s/ Jack E. Stover
  Name: Jack E. Stover
  Title: President and Chief Executive Officer

 

 

 

 

EXHIBIT INDEX

 

Exhibit Number   Description
99.1   Press Release dated September 20, 2017 (furnished pursuant to Item 7.01).
99.2   Written Notice, dated September 18, 2017, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (filed herewith pursuant to Item 8.01).

 

 

 

EX-99.1 2 ex99-1.htm

 

Interpace Diagnostics Announces Receipt of Letter From Nasdaq Confirming Compliance With Audit Committee Requirements

 

Parsippany, NJ, September 20, 2017— Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) (the “Company” or “Interpace”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management, today announced that on September 18, 2017, the Company received a letter from The Nasdaq Stock Market LLC stating that the Company has regained compliance with Listing Rule 5605(c)(2), which requires the Company to maintain three audit committee members on its Board of Directors. Jack E. Stover, President and CEO of Interpace Diagnostics, stated, “We are pleased that the Company has regained compliance with all NASDAQ listing requirements and can continue to transform itself for growth.”

 

About Interpace Diagnostics Group, Inc.

 

Interpace is a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has three commercialized molecular tests; PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX®, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR®, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace’s mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science. For more information, please visit Interpace’s website at www.interpacediagnostics.com

 

About Thyroid Nodules, ThyGenX and ThyraMIR testing

 

According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.

 

ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.

 

ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.

 

 
 

 

About Pancreatic Cysts and PancraGEN

 

PancraGEN is a pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, can aid in pancreatic cancer risk assessment. PancraGEN is 90% accurate, according to clinical studies, enabling effective risk stratification of patients. Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths.

 

Forward Looking Statements

 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to our future financial and operating performance. The company has attempted to identify forward looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, our ability to adequately finance the business, our ability to restructure our liabilities and other obligations, the market’s acceptance of our molecular diagnostic tests; our ability to retain or secure reimbursement, our ability to secure additional business and generate higher profit margins through sales of our molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments and our ability to maintain our NASDAQ listing. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company’s periodic filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 31, 2017 and the amendment on Form 10-K/A filed on April 28, 2017, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 filed with the SEC on May 12, 2017, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 filed with the SEC on August 10, 2017 and the Company’s Registration Statement on Form S-1, as amended (333-218140) initially filed with the SEC on May 22, 2017. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

 

Morris Corporate Center 1, Building C, 300 Interpace Parkway, Parsippany, New Jersey 07054

Phone: 862-207-7800 • Toll Free: 800-242-7494 • www.interpacediagnostics.com

 

CONTACTS:

 

Interpace Diagnostics

Investor Relations:

 

Paul Kuntz

Redchip

Paul@Redchip.com

 

Morris Corporate Center 1, Building C, 300 Interpace Parkway, Parsippany, New Jersey 07054

Phone: 862-207-7800 • Toll Free: 800-242-7494 • www.interpacediagnostics.com

 

 
 

EX-99.2 3 ex99-2.htm

 

 

 

‌‌

Sent via Electronic Delivery to: jstover@interpacedx.com

 

September 18, 2017

 

Mr. Jack E. Stover

Chief Executive Officer

Interpace Diagnostics Group, Inc.

Morris Corporate Center 1, Building A

300 Interpace Parkway, Parsippany, NJ 07054

 

Re: Interpace Diagnostics Group, Inc. (the “Company”)
  Nasdaq Symbol: IDXG

 

Dear Mr. Stover:

 

On October 6, 2016, Staff notified the Company that it did not comply with the audit committee requirements for continued listing on The Nasdaq Capital Market set forth in Listing Rule 5605(c)(2) (the “Rule”). Based on the information regarding the appointment of Dr. Felice Schnoll-Sussman to the Company’s Board of Directors and audit committee, as detailed in your Form 8-K dated September 13, 2017, Staff has determined that the Company complies with the Rule and this matter is now closed.

 

If you have any questions, please contact Shawn Abdool, Listing Analyst, at +1 301 978 8030.

 

Sincerely,‌‌

 

 

 

Randy Genau

Director

Nasdaq Listing Qualifications

 

 

 

 

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