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): November 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.  ☐  

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On November 12, 2020, we issued a press release announcing our financial results for the three and nine months ended September 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 November 12, 2020.

 

 

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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 Third Quarter 2020 Financial Results

 

Revenues of $6.6 million –

a result of decision to offer COVID-19 testing

 

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

 

SAN DIEGO (November 12, 2020) – Biocept, Inc. (Nasdaq: BIOC), a leading commercial provider of molecular diagnostic assays, products and services designed to provide physicians with clinically actionable information to improve patient outcomes, reports financial results for the three and nine months ended September 30, 2020 and provides an update on its business progress.

 

“Third quarter revenues increased more than four-fold compared with the third quarter of 2019 to $6.6 million due to our decision to perform and offer COVID-19 RT-PCR testing.  I am very proud of our hard-working team who have rallied to support public health efforts with our COVID-19 testing, while continuing to provide excellent service for our core oncology clients and the patients under their care,” said Michael Nall, President and CEO of Biocept.  

 

“Offering COVID-19 testing services was the right thing to do, and we fully expect this testing to be an important part of our business until the pandemic subsides,” he added.  “That said, oncology remains our long-term focus and we continue executing on priorities to build our business for a strong post-pandemic future.

 

“During the quarter we experienced an anticipated recovery in our oncology testing volume over the second quarter, driven by our new strategy in neuro-oncology.  Our Target Selector™ CSF assays are proving to be more sensitive than conventional cytology alone in detecting lung and breast cancer that has metastasized to the brain or central nervous system,” said Mr. Nall.  “These CSF assays have value as a diagnostic tool in helping to determine whether a patient’s cancer has metastasized to the cerebrospinal fluid and in profiling biomarkers to help physicians with treatment selection.  We are implementing new clinical programs focused on neuro-oncology testing, which we view as a significant growth opportunity.”

 

Third Quarter 2020 and Recent Highlights

 

Corporate Developments

 

Commercial Developments and Agreements

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Development

 

Industry Conference Presentation

 

Intellectual Property

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Third Quarter Financial Results

 

Revenues for the third quarter of 2020 were $6.6 million, compared with $1.5 million for the third quarter of 2019, with the increase attributable to RT-PCR COVID-19 testing.  Revenues for the third quarter of 2020 included $6.4 million in commercial test revenue, which includes $5.7 million attributable to RT-PCR COVID-19 testing, $47,000 in development services test revenue and $154,000 in revenue for distributed products, Target Selector™ RUO kits, CEE-Sure® blood collection tubes  and payments from Aegea Bioscience for services associated with the development of a COVID-19 assay.  Revenues for the third quarter of 2019 included $1.4 million in commercial test revenue, $38,000 in development services test revenue and $59,000 from distributed products.

 

Biocept accessioned 52,993 total samples during the third quarter of 2020, compared with 1,429 total samples during the third quarter of 2019.  The Company accessioned 52,773 billable samples during the third quarter of 2020, compared with 1,189 billable samples during the third quarter of 2019.  The increase in total and billable samples was attributable primarily to RT-PCR COVID-19 testing.  

 

Cost of revenues for the third quarter of 2020 was $5.9 million, compared with $2.8 million for the third quarter of 2019.  Research and development (R&D) expenses for the third quarter of 2020 were $1.1 million, compared with $1.2 million for the third quarter of 2019, with the decrease primarily due to a reduction in laboratory allocated costs.  General and administrative (G&A) expenses for the third quarter of 2020 were $3.0 million, compared with $1.7 million for the third quarter of 2019, with the increase primarily due to legal and investor relations expenses, as well as headcount additions to handle COVID-19 related activities.  Sales and marketing expenses for the third quarter of 2020 were $1.4 million, compared with $1.5 million for the third quarter of 2019, staying relatively flat due to curtailed sales and marketing activities due to the pandemic.

 

The net loss attributable to common shareholders for the third quarter of 2020 was $4.9 million, or $0.43 per share on 11.3 million weighted-average shares outstanding.  The net loss attributable to common shareholders for the third quarter of 2019 was $5.7 million, or $2.47 per share on 2.3 million weighted-average shares outstanding.  

 

Nine Month Financial Results

 

Revenues for the first nine months of 2020 were $9.0 million, compared with $3.7 million for the first nine months of 2019.  Revenues for the first nine months of 2020 included $8.5 million in commercial test revenue, which includes $5.7 million attributable to RT-PCR COVID-19 testing, $145,000 in development services test revenue and $261,000 in revenue for Target Selector™ RUO kits, CEE-Sure blood collection tubes and payments from Aegea Bioscience for services associated with the development of a COVID-19 assay.

 

Operating expenses for the first nine months of 2020 were $26.4 million, and included cost of revenues of $11.3 million, R&D expenses of $4.0 million, G&A expenses of $6.8 million and sales and marketing expenses of $4.2 million. Operating expenses for the first nine months of 2019 were $21.2 million, and included cost of revenues of $8.1 million, R&D expenses of $3.5 million, G&A expenses of $5.1 million and sales and marketing expenses of $4.5 million.

 

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The net loss for the first nine months of 2020 was $19.7 million, or $1.48 per share on 13.3 million weighted-average shares outstanding.  This compares with a net loss for the first nine months of 2019 of $19.5 million, or $10.96 per share on 1.8 million weighted-average shares outstanding. 

 

Biocept reported cash and cash equivalents as of September 30, 2020 of $16.9 million, compared with $9.3 million as of December 31, 2019. In the third quarter of 2020, as a result of sales and anticipated demand for COVID-19 testing, the Company increased consumable inventory by $2.3 million and grew accounts receivable by $4.8 million.

 

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 10149217.  A replay of the webcast will be available for 90 days.

 

About Biocept

 

Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, melanoma, and tumors metastatic to the central nervous system (brain and spinal cord). 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) found in both blood and Cerebral Spinal Fluid.  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. In addition, Biocept is conducting COVID-19 testing to support efforts to fight the pandemic. For additional 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, the future role of COVID-19 testing in our business, the sensitivity of our Target Selector CSF assays in detecting lung and breast cancer and the value of such assays as a diagnostic tool and in profiling biomarkers to help physicians with treatment selection, the potential growth of our new clinical programs focused on neuro-oncology testing, the timing of our COVID-19 sample collection tubes validation and patent filing, the potential of our development agreement with Aegea Biotechnologies, including the potential to utilize Switch-Blocker™ technology to develop a new, highly sensitive, next-generation PCR-based COVID-19 and molecular diagnostics for other infectious diseases, the potential role of Target Selector in providing information to neuro-oncologists in making treatment decisions for patients with lung cancer metastases to the brain and spinal cord,

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and our upcoming presentation at the Society for Neuro-Oncology’s SNO2020 Virtual Conference, 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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