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): April 9, 2020

 

 

BIOCEPT, INC.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

 

 

Delaware

 

001-36284

 

80-0943522

(State or other jurisdiction of

incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

 

 

 

5810 Nancy Ridge Drive, San Diego, CA

  

92121

(Address of principal executive offices)

  

(Zip Code)

Registrant’s telephone number, including area code: (858) 320-8200

 

 

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))

 

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

 

 

 

 

 

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

BIOC

 

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 (§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 8.01 Other Events.

On April 9, 2020, Biocept, Inc. (the “Company”) issued a press release announcing that the Company has verified a COVID-19 molecular diagnostic test and plans to begin accepting physician-ordered testing requests for processing beginning on April 15, 2020.

 

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Forward-Looking Statements Disclaimer Statement; Risk Factor

 

This report, including Exhibit 99.1, contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this report are not strictly historical, including without limitation statements as to our ability to improve the outcomes of patients diagnosed with cancer, the exact time that we will begin accepting physician-ordered COVID-19 testing requests for processing, and our ability to enter into additional agreements to accept COVID-19 patient samples, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC). The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this report. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this report except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC's website located at www.sec.gov.

In addition, while we are pleased to have an opportunity to support our clients and public health efforts by offering critical COVID-19 testing to physicians, we cannot predict with any degree of accuracy the quantity of COVID-19 testing that we will conduct in the future, if any, or the net revenues we will receive therefrom. There are several other medical laboratories that currently offer or may offer their own COVID-19 testing services to the same markets that we serve.  It is entirely possible, if not likely, that our COVID-19 testing services will not have a significant impact on our results of operations.

Item 9.01 Financial Statements and Exhibits.

 

(d)

Exhibits

 

 

 

 

Exhibit
No.

 

Exhibit Title or Description

 

 

 

 

99.1

Press release dated April 9, 2020

 

 

 

 

 

 


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.

 

 

 

 

 

 

 

 

 

 

 

 

Biocept, Inc.

 

 

 

 

Date: April 13, 2020

 

 

 

By:

 

/s/ Michael W. Nall

 

 

 

 

 

 

Michael W. Nall

 

 

 

 

 

 

Chief Executive Officer

 

EXHIBIT 99.1

Biocept to Begin COVID-19 Testing

 

Company to provide FDA-approved for EUA testing in its San Diego lab to assist physician clients in the fight against the coronavirus pandemic

 

SAN DIEGO (April 9, 2020) – Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces that it has verified a COVID-19 molecular diagnostic test, and plans to begin accepting physician-ordered testing requests for processing beginning on April 15, 2020.

 

Biocept has partnered with a national clinician network to accept patient samples and may obtain additional agreements as test capacity is increased.  Biocept operates a high-complexity, CLIA-certified, CAP-accredited and BSL-2 safety level laboratory in San Diego, with specialized, licensed molecular lab staff that have been trained in performing the COVID-19 testing. The lab will be using the FDA-approved for EUA (Emergency Use Authorization) testing ThermoFisher Scientific’s TaqPath™ molecular diagnostic platform and kit for SARS-CoV-2 (COVID-19).

 

"While we continue to focus primarily on providing actionable results for patients diagnosed with cancer, we are pleased to support our clients and public health efforts by expanding our offerings to include COVID-19 testing. I am very thankful to our laboratory team for stepping up and quickly validating COVID-19 testing, in addition to the vital work we do each day for patients diagnosed with cancer,” said Mike Nall, Biocept's Chief Executive Officer.  “We will provide this critical testing to physicians as we fight the global coronavirus pandemic.”

 

In preparation to offer COVID-19 testing, an unapproved version of a test website page was inadvertently posted to the Company’s website by a third-party website consultant.  This unapproved test website page contained certain inaccuracies related to billing matters and should be disregarded.    

 

For physician questions, please contact customerservice@biocept.com.

 

About Biocept

 

Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company uses its proprietary liquid biopsy technology to provide physicians with clinically actionable information for treating and monitoring patients diagnosed with cancer. The Company's patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor cells (CTCs) and in circulating tumor DNA (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient’s disease and therapeutic options. For additional information, please visit www.biocept.com.

 

 

 

 

Forward-Looking Statements Disclaimer Statement

 

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the outcomes of patients diagnosed with cancer, the exact time that we will begin accepting physician-ordered COVID-19 testing requests for processing, and our ability to enter into additional agreements to accept COVID-19 patient samples, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC's website located at www.sec.gov.

 

Investor Contact:

LHA Investor Relations

Jody Cain

Jcain@lhai.com

310-691-7100

 

Media Contact:

CORE IR

Jules Abraham

julesa@coreir.com

917-885-7378

 

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