10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to .

Commission file number: 001-36284

Biocept, Inc.

(Exact name of registrant as specified in its charter)

Delaware

80-0943522

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

9955 Mesa Rim Road, San Diego, California

(Address of principal executive offices)

92121

(Zip Code)

(858) 320-8200

(Registrant’s telephone number, including area code)

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the 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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

 

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.

Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act). Yes No

As of August 8, 2023, there were 2,626,026 shares of the Registrant’s common stock outstanding.

 


 

BIOCEPT, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED

June 30, 2023

INDEX

Page

 

 

IMPORTANT NOTE REGARDING FORWARD-LOOKING STATEMENTS

3

 

 

 

PART I.

FINANCIAL INFORMATION

5

 

 

 

Item 1.

Financial Statements

5

 

 

 

Condensed Balance Sheets as of June 30, 2023 (Unaudited) and December 31, 2022

5

 

 

 

Condensed Statements of Operations for the three and six months ended June 30, 2023 and 2022 (Unaudited)

6

 

 

 

Condensed Statements of Stockholders’ Equity for the three and six months ended June 30, 2023 and 2022 (Unaudited)

7

 

 

 

Condensed Statements of Cash Flows for the six months ended June 30, 2023 and 2022 (Unaudited)

8

 

 

 

Notes to Condensed Financial Statements (Unaudited)

9

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

21

 

 

 

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

30

 

 

 

Item 4.

Controls and Procedures

 

30

 

 

 

PART II.

OTHER INFORMATION

33

 

 

 

Item 1.

Legal Proceedings

33

 

 

 

 

 

Item 1A.

Risk Factors

33

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

64

 

 

 

Item 3.

Defaults Upon Senior Securities

64

 

 

 

Item 4.

Mine Safety Disclosures

64

 

 

 

Item 5.

Other Information

64

 

 

 

Item 6.

Exhibits

65

 

 

 

 

2


 

IMPORTANT NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements included or incorporated by reference in this Quarterly Report other than statements of historical fact, are forward-looking statements. You can identify these and other forward-looking statements by the use of words such as “may,” “will,” “could,” “anticipate,” “expect,” “intend,” “believe,” “continue,” “plan,” “estimate,” “potentially,” “predict,” “should” or the negative of such terms, or other comparable terminology. Forward-looking statements also include the assumptions underlying or relating to such statements.

Forward-looking statements may include, but are not limited to, statements about:

the performance of our products, assays and services;
the ability of our products, assays and services to become a key component of the standard of care for personalized cancer treatment;
our ability to generate revenue, grow our business and increase sales of our products, assays and services;
our ability to develop and commercialize new products, diagnostic assays, services and enhance our current products, assays and services and future products, assays, and services;
our plans to launch a series of cancer diagnostic assays for different predictive biomarkers;
our ability to effectively compete with other products, diagnostic assays, methods and services that now exist or may hereafter be developed;
our ability to expand our international business and commercialize our products and assays in other countries;
market adoption of our products and assays and our ability to successfully complete clinical utility studies;
our FORESEE trial, including anticipated timelines for progressing and completing the trial;
the potential for CNSide to be included in NCCN guidelines;
our ability to obtain coverage and adequate reimbursement from governmental and other third-party payors for assays and services;
our expectations regarding our material cash requirements, contractual obligations and commitments and the use of our existing cash;
our ability to enter into and leverage agreements with commercialization partners for the sales, marketing and commercialization of our current products, assays and services, and our planned future products, assays and services;
our ability to satisfy any applicable United States and international regulatory requirements with respect to products, assays and services;
our ability to obtain or maintain patents or other appropriate protection for the intellectual property utilized in our current and planned products, assays and services;
potential effects of an epidemic or pandemic on our business;
our estimates regarding the period of time for which our current capital resources will be sufficient to fund our continued operations;
our expectations and estimates regarding our future use of cash, expenses and costs and needs for additional financing; and
our ability to maintain a strong internal control environment and remediate internal control deficiencies.

 

3


 

Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in this report under the “Management’s Discussion and Analysis” and “Risk Factors” headings.

Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time, and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they are made except as required by law. Readers should, however, review the factors and risks we describe in the reports we file from time to time with the SEC. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date the statement is made, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.

 

 

 

 

4


 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

Biocept, Inc.

 

Condensed Balance Sheets

 

(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

June 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

(unaudited)

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash

 

$

6,633

 

 

$

12,897

 

Accounts receivable

 

 

800

 

 

 

2,151

 

Inventories, net

 

 

551

 

 

 

757

 

Prepaid expenses and other current assets

 

 

876

 

 

 

538

 

Total current assets

 

 

8,860

 

 

 

16,343

 

Fixed assets, net

 

 

2,395

 

 

 

2,572

 

Lease right-of-use asset - operating

 

 

8,190

 

 

 

8,486

 

Lease right-of-use assets - finance

 

 

2,272

 

 

 

3,086

 

Other non-current assets

 

 

386

 

 

 

386

 

Total assets

 

$

22,103

 

 

$

30,873

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,467

 

 

$

1,523

 

Accrued liabilities

 

 

1,529

 

 

 

2,249

 

Current portion of lease liability - operating

 

 

565

 

 

 

518

 

Current portion of lease liabilities - finance

 

 

815

 

 

 

1,099

 

Financed insurance premiums

 

 

526

 

 

 

117

 

Total current liabilities

 

 

4,902

 

 

 

5,506

 

Non-current portion of lease liability - operating

 

 

8,849

 

 

 

9,175

 

Non-current portion of lease liabilities - finance

 

 

836

 

 

 

1,200

 

Payor liability

 

 

6,149

 

 

 

6,132

 

Warrant liability

 

 

1,077

 

 

 

 

Total liabilities

 

 

21,813

 

 

 

22,013

 

Commitments and contingencies (see Note 11)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value, 5,000,000 shares authorized; 2,090 shares issued and outstanding at June 30, 2023 and December 31, 2022

 

 

 

 

 

 

Common stock, $0.0001 par value, 150,000,000 shares authorized; 2,407,381 shares and 568,994 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively.

 

 

 

 

 

 

Additional paid-in capital

 

 

309,503

 

 

 

307,298

 

Accumulated deficit

 

 

(309,213

)

 

 

(298,438

)

Total stockholders’ equity

 

 

290

 

 

 

8,860

 

Total liabilities and stockholders’ equity

 

$

22,103

 

 

$

30,873

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

 

 

5


 

 

 

Biocept, Inc.

 

Condensed Statements of Operations

 

(In thousands, except shares and per share data)

 

(Unaudited)

 

 

 

 

 

 

 

 

 

 

For the Three Months Ended June 30,

 

 

For the Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Net revenues

 

$

589

 

 

$

5,819

 

 

$

1,262

 

 

$

25,763

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenues

 

 

2,550

 

 

 

8,023

 

 

 

5,578

 

 

 

18,357

 

Research and development expenses

 

 

409

 

 

 

1,729

 

 

 

1,449

 

 

 

3,574

 

General and administrative expenses

 

 

3,494

 

 

 

4,300

 

 

 

6,482

 

 

 

10,556

 

Sales and marketing expenses

 

 

250

 

 

 

1,656

 

 

 

965

 

 

 

5,314

 

Total costs and expenses

 

 

6,703

 

 

 

15,708

 

 

 

14,474

 

 

 

37,801

 

Loss from operations

 

 

(6,114

)

 

 

(9,889

)

 

 

(13,212

)

 

 

(12,038

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(50

)

 

 

(155

)

 

 

(96

)

 

 

(217

)

Other income, net

 

 

91

 

 

 

 

 

 

91

 

 

 

 

Change in fair value of warrant liability

 

 

2,442

 

 

 

 

 

 

2,442

 

 

 

 

Total other income (expense):

 

 

2,483

 

 

 

(155

)

 

 

2,437

 

 

 

(217

)

Loss before income taxes

 

 

(3,631

)

 

 

(10,044

)

 

 

(10,775

)

 

 

(12,255

)

Income tax expense

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

(3,631

)

 

 

(10,044

)

 

 

(10,775

)

 

 

(12,255

)

Net loss attributable to common stockholders

 

$

(3,631

)

 

$

(10,044

)

 

$

(10,775

)

 

$

(12,255

)

Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

1,036,529

 

 

 

563,528

 

 

 

813,180

 

 

 

562,561

 

Diluted

 

 

1,036,529

 

 

 

563,528

 

 

 

813,180

 

 

 

562,561

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(3.50

)

 

$

(17.82

)

 

$

(13.25

)

 

$

(21.78

)

Diluted

 

$

(3.50

)

 

$

(17.82

)

 

$

(13.25

)

 

$

(21.78

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

 

 

6


 

 

Biocept, Inc.

 

Condensed Statements of Stockholders' Equity

 

(In thousands, except for shares)

 

(Unaudited)

 

 

 

Common Stock

 

 

Series A
Convertible
Preferred Stock

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional
Paid-in Capital

 

 

Accumulated
Deficit

 

 

Total

 

Balance at December 31, 2022

 

 

568,994

 

 

$

 

 

 

2,090

 

 

$

 

 

$

307,298

 

 

$

(298,438

)

 

$

8,860

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

316

 

 

 

 

 

 

316

 

Shares issued for ATM transaction, net of issuance costs

 

 

23,903

 

 

 

 

 

 

 

 

 

 

 

 

396

 

 

 

 

 

 

396

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,144

)

 

 

(7,144

)

Balance at March 31, 2023

 

 

592,897

 

 

$

 

 

 

2,090

 

 

$

 

 

$

308,010

 

 

$

(305,582

)

 

$

2,428

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

209

 

 

 

 

 

 

209

 

Shares issued for May 2023 financing transaction, net of issuance costs

 

 

1,176,470

 

 

 

 

 

 

 

 

 

 

 

 

484

 

 

 

 

 

 

484

 

Shares issued for exercise of May 2023 warrants

 

 

638,014

 

 

 

 

 

 

 

 

 

 

 

 

800

 

 

 

 

 

 

800

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,631

)

 

 

(3,631

)

Balance at June 30, 2023

 

 

2,407,381

 

 

$

 

 

 

2,090

 

 

$

 

 

$

309,503

 

 

$

(309,213

)

 

$

290

 

 

 

 

Common Stock

 

 

Series A
Convertible
Preferred Stock

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional
Paid-in Capital

 

 

Accumulated
Deficit

 

 

Total

 

Balance at December 31, 2021

 

 

561,652

 

 

$

 

 

 

2,106

 

 

$

 

 

$

303,831

 

 

$

(266,351

)

 

$

37,480

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,759

 

 

 

 

 

 

1,759

 

Shares issued upon conversion of preferred stock

 

 

12

 

 

 

 

 

 

(16

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,210

)

 

 

(2,210

)

Balance at March 31, 2022

 

 

561,664

 

 

$

 

 

 

2,090

 

 

$

 

 

$

305,590

 

 

$

(268,561

)

 

$

37,029

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

585

 

 

 

 

 

 

585

 

Shares issued for ATM transaction, net of issuance costs

 

 

2,424

 

 

 

 

 

 

 

 

 

 

 

 

94

 

 

 

 

 

 

94

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(10,044

)

 

 

(10,044

)

Balance at June 30, 2022

 

 

564,088

 

 

$

 

 

 

2,090

 

 

$

 

 

$

306,269

 

 

$

(278,605

)

 

$

27,664

 

 

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

 

 

 

7


 

 

Biocept, Inc.

 

Condensed Statements of Cash Flows

 

(in thousands)

 

(Unaudited)

 

 

 

For the Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

Cash Flows from Operating Activities

 

 

 

 

 

 

Net loss

 

$

(10,775

)

 

$

(12,255

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

984

 

 

 

810

 

Noncash operating lease expense

 

 

296

 

 

 

268

 

Stock-based compensation

 

 

525

 

 

 

2,344

 

Loss on disposal of fixed assets

 

 

36

 

 

 

 

Gain on finance lease termination

 

 

(125

)

 

 

 

Other non-cash

 

 

2

 

 

 

 

Transaction costs allocated to warrants

 

 

505

 

 

 

 

Change in fair value of warrant liability

 

 

(2,442

)

 

 

 

Increase (decrease) in cash resulting from changes in:

 

 

 

 

 

 

Accounts receivable

 

 

1,351

 

 

 

1,203

 

Inventory

 

 

206

 

 

 

402

 

Prepaid expenses and other current assets

 

 

500

 

 

 

6

 

Other non-current assets

 

 

 

 

 

(41

)

Accounts payable

 

 

308