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): August 12, 2020

BIOCEPT, INC.

(Exact name of registrant as specified in its charter)

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:

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

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.  ☐  

On August 12, 2020, we issued a press release announcing our financial results for the three and six months ended June 30, 2020.  A copy of the press release and accompanying information is attached as Exhibit 99.1 to this current report.

The information in this Item 2.02, and 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, or otherwise subject to the liabilities of that Section. The information in this current report shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission, whether filed before or after the date hereof regardless of any general incorporation language in any such filing, unless we expressly set forth in such filing that such information is to be considered “filed” or incorporated by reference therein.

(d) Exhibits

99.1 Press Release dated August 12, 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.

EXHIBIT 99.1

Biocept Reports Second Quarter 2020 Financial Results

Conference call begins at 4:30 p.m. Eastern time today

SAN DIEGO (August 12, 2020) – Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular technologies designed to provide physicians with clinically actionable information to improve the outcomes of patients, reports financial results for the three and six months ended June 30, 2020 and provides an update on its business progress.

“Due to our decision to initiate COVID-19 testing, overall commercial volume during the second quarter increased slightly versus the prior year, even with the impact of the pandemic,” said Michael Nall, President and CEO of Biocept. “Commercial volume in our core oncology business was down 16% year-over-year, which is significantly better than the decline of up to 40% we anticipated in our second quarter forecast.  We reached a low point in oncology testing early in the second quarter, with subsequent improvement as the quarter progressed. However, with the resurgence of the pandemic, physicians report that patient office visits have not returned to pre-COVID levels, which is continuing to affect our oncology testing volume. In addition to the launch of our COVID-19 testing service, our better-than-expected performance was driven in part by new assays that evaluate the cerebrospinal fluid of patients with breast or lung cancer suspected of brain or central nervous system metastases.  Revenues for the quarter decreased 23% year-over-year, as a result of fewer patient visits to physician offices attributed to the concerns about COVID 19.  That said, revenues for the first half of 2020 were up 7% over the prior year, driven by our strong first quarter performance before the full impact of the pandemic.

“For the immediate future, COVID-19 testing is an important part of our business and I’m pleased to report that we have received over 11,000 specimens to date,” he added.  “We have secured components to date for approximately 50,000 COVID-19 specimen collection kits to support current testing and expect to begin shipping our own COVID-19 specimen collection kits to our lab services customers later this year, which will contain our proprietary VEE-SURE™ viral transport media.  These kits will be available for use in our lab or can be sold to other labs.  We are excited about our recent development agreement with Aegea Biotechnologies to utilize Switch-Blocker™ technology to develop tests that could increase sensitivity in detecting SARS-CoV-2, the virus that causes COVID-19, and provide additional information on specific strain types.  

“We are proud to support public health efforts by offering COVID-19 testing and plan to develop and offer these critical products and services for as long as they are needed,” said Mr. Nall.  “As a long-term strategy, we remain focused on oncology and believe we are well positioned to weather the pandemic as we continue to make progress on multiple aspects of our core business and build for a strong future.  We are an established leader in liquid biopsy with our Target Selector™ assays, providing information that is critical to physician decision-making for their patients diagnosed with cancer.  We expect that when the pandemic subsides, our commercial oncology volume will return to growth.  We believe our recently strengthened balance sheet will support this strategy.”

Second Quarter 2020 and Recent Highlights

Commercial Launches

Development Agreement

Commercial Agreements

Industry Conference Presentation

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Intellectual Property

Corporate Developments

Second Quarter Financial Results

Revenues for the second quarter of 2020 were $917,000, compared with $1.2 million for the second quarter of 2019, with the decrease attributable to the impact of the COVID-19 pandemic.  Revenues for the second quarter of 2020 included $841,000 in commercial test revenue, $38,000 in development services test revenue and $38,000 in revenue for distributed products, Target Selector™ RUO kits and CEE-Sure® blood collection tubes.  Revenues for the second quarter of 2019 included $1.1 million in commercial test revenue, $45,000 in development services test revenue and $28,000 from RUO kits and blood collection tubes.

Biocept accessioned 1,399 total samples during the second quarter of 2020, compared with 1,340 total samples during the second quarter of 2019.  The Company accessioned 1,184 billable samples during the second quarter of 2020, compared with 1,211 billable samples during the second quarter of 2019.  The decline in billable samples was attributable to the impact of the COVID-19 pandemic.

Cost of revenues for the second quarter of 2020 was $2.5 million, compared with $2.7 million for the second quarter of 2019, with the decrease primarily due to lower revenues attributable to the impact of the COVID-19 pandemic.

Research and development (R&D) expenses for the second quarter of 2020 were $1.6 million, compared with $1.1 million for the second quarter of 2019, with the increase primarily due to the launch of COVID-19 PCR testing, laboratory automation projects, and ongoing development and validation of liquid biopsy panels.  General and administrative (G&A) expenses for the second quarter of 2020 were $1.9 million, compared with $1.7 million for the second quarter of 2019, with the increase due mainly to higher insurance costs, and higher legal fees primarily related to lease negotiations, warrant exercises and other matters.  Sales and marketing expenses for the second quarter of 2020 were $1.3 million, compared with $1.6 million for the second quarter of 2019, with the decrease primarily attributable to lower sales and marketing activities due to pandemic-related travel restrictions.

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Other expense, net for the second quarter of 2020 was $56,000, compared with $1.9 million for the second quarter of 2019, which included $1.8 million in warrant inducement expense.

The net loss attributable to common shareholders for the second quarter of 2020 was $6.5 million, or $0.05 per share on 127.2 million weighted-average shares outstanding.  The net loss attributable to common shareholders for the second quarter of 2019 was $7.8 million, or $0.38 per share on 20.5 million weighted-average shares outstanding.  

Six Month Financial Results

Revenues for the first six months of 2020 were $2.4 million, a 7% increase from $2.2 million for the first six months of 2019, and included $2.2 million in commercial test revenue, $99,000 in development services test revenue and $107,000 in revenue for Target Selector™ RUO kits and CEE-Sure blood collection tubes.

Operating expenses for the first six months of 2020 were $15.0 million, and included cost of revenues of $5.5 million, R&D expenses of $2.9 million, G&A expenses of $3.8 million and sales and marketing expenses of $2.8 million.

The net loss for the first six months of 2020 was $14.8 million, or $0.14 per share on 103.1 million weighted-average shares outstanding.  This compares with a net loss for the first six months of 2019 of $13.8 million, or $0.83 per share on 16.7 million weighted-average shares outstanding. 

Biocept reported cash and cash equivalents as of June 30, 2020 of $24.1 million, compared with $9.3 million as of December 31, 2019.  The increase included approximately $27.3 million in net proceeds from three registered direct offerings in 2020, and exercise of overallotment of warrants from the December 2019 financing.  

Conference Call and Webcast

Biocept will hold a conference call today at 4:30 p.m. Eastern time to discuss these results and answer questions.  The conference call can be accessed by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4109 for other international callers.  A live webcast of the conference call will be available on the investor relations page of the company’s website at http://ir.biocept.com/events.cfm.

A replay of the call will be available for 48 hours following its conclusion and can be accessed by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers or (412) 317-0088 for other international callers. Please use event passcode 10145918.  A replay of the webcast will be available for 90 days.

About Biocept

Biocept is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. Biocept uses its proprietary liquid biopsy technology to provide physicians with clinically actionable information for treating and monitoring patients diagnosed with cancer.  Biocept’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. Additionally, Biocept is offering

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nationwide COVID-19 polymerase chain reaction (PCR) testing to support public health efforts during this unprecedented pandemic. For more information, please visit www.biocept.com.

Forward-Looking Statements Disclaimer Statement

This news 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 be 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 news release are not strictly historical, including, without limitation, statements as to our ability to provide physicians with clinically actionable information to improve the outcomes of cancer patients, our ability to perform COVID-19 testing and the likelihood of such test volume to be sustainable, our ability to provide and the timing of availability of our own COVID-19 specimen collection kits, the potential of our recent development agreement with Aegea Biotechnologies, including the potential to utilize Switch-Blocker™ technology to develop tests that could increase sensitivity in detecting SARS-CoV-2, and our ability to weather the COVID-19 pandemic and return commercial volume to normal levels and grow our business following the pandemic subsiding, 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 news 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 at http://www.sec.gov/.

Investor Contact:

LHA Investor Relations

Jody Cain

Jcain@lhai.com

(310) 691-7100

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BIOCEPT, INC.

CONDENSED BALANCE SHEETS

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BIOCEPT, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

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