Biocept Inc.
BIOCEPT INC (Form: 10-Q, Received: 11/09/2015 16:16:44)

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x

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

For the quarterly period ended September 30, 2015

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.)

5810 Nancy Ridge Drive, 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)

 

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  x  No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes  x  No  ¨

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

 

Large accelerated filer

 

¨

  

Accelerated filer

 

¨

 

 

 

 

Non-accelerated filer

 

¨   (Do not check if a smaller reporting company)

  

Smaller reporting company

 

x

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

As of November 2, 2015, there were 18,806,903 shares of the Registrant’s common stock outstanding.

 

 

 

 

 


BIOCEPT, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED

September 30, 2015

INDEX

 

 

 

 

  

Page

 

 

IMPORTANT NOTE REGARDING FORWARD-LOOKING STATEMENTS

  

3

 

 

 

PART I.

 

FINANCIAL INFORMATION

  

 

 

 

 

Item 1.

 

Financial Statements

  

4

 

 

 

 

 

Condensed Balance Sheets as of December 31, 2014 and September 30, 2015 (unaudited)

  

4

 

 

 

 

 

Condensed Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2014 and 2015 (unaudited)

  

5

 

 

 

 

 

Condensed Statements of Cash Flows for the nine months ended September 30, 2014 and 2015 (unaudited)

  

6

 

 

 

 

 

Notes to Condensed Financial Statements (unaudited)

  

8

 

 

 

Item 2.

 

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

  

18

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

  

25

 

 

 

Item 4.

 

Controls and Procedures

  

26

 

 

 

PART II.

 

OTHER INFORMATION

  

 

 

 

 

Item 1.

 

Legal Proceedings

  

27

 

 

 

 

 

Item 1A.

 

Risk Factors

  

27

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

  

27

 

 

 

Item 3.

 

Defaults Upon Senior Securities

  

27

 

 

 

Item 4.

 

Mine Safety Disclosures

  

27

 

 

 

Item 5.

 

Other Information

  

28

 

 

 

Item 6.

 

Exhibits

  

28

 

 

 

2


I MPORTANT NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (“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” or the negative of such terms, or other comparable terminology. Forward-looking statements also include the assumptions underlying or relating to such statements.

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 our other filings with the Securities and Exchange Commission (the “SEC”). 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 and registration statements we file from time to time with the SEC.

 

 

 

3


P ART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

Biocept, Inc.

Condensed Balance Sheets

 

 

December 31,

 

 

September 30,

 

 

2014

 

 

2015

 

 

 

 

 

 

(unaudited)

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

5,364,582

 

 

$

12,541,919

 

Accounts receivable

 

10,600

 

 

 

40,360

 

Inventories, net

 

188,728

 

 

 

302,005

 

Prepaid expenses and other current assets

 

338,721

 

 

 

456,894

 

Total current assets

 

5,902,631

 

 

 

13,341,178

 

Fixed assets, net

 

662,422

 

 

 

855,208

 

Total assets

$

6,565,053

 

 

$

14,196,386

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

641,406

 

 

$

766,436

 

Accrued liabilities

 

699,903

 

 

 

916,730

 

Supplier financings

 

33,674

 

 

 

 

Current portion of equipment financings

 

55,800

 

 

 

125,920

 

Current portion of credit facility

 

 

 

 

1,556,909

 

Current portion of deferred rent

 

 

 

 

24,752

 

Total current liabilities

 

1,430,783

 

 

 

3,390,747

 

Non-current portion of equipment financings, net

 

68,801

 

 

 

244,612

 

Non-current portion of credit facility, net

 

4,731,322

 

 

 

3,020,166

 

Non-current portion of interest payable

 

54,537

 

 

 

131,543

 

Non-current portion of deferred rent

 

500,179

 

 

 

481,041

 

Total liabilities

 

6,785,622

 

 

 

7,268,109

 

Commitments and contingencies (see Note 10)

 

 

 

 

 

 

 

Shareholders’ equity/(deficit):

 

 

 

 

 

 

 

Common stock, $0.0001 par value, 40,000,000 authorized; 4,449,603 issued and

   outstanding at December 31, 2014; 18,766,903 issued and outstanding at

   September 30, 2015 (see Note 2)

 

445

 

 

 

1,877

 

Additional paid-in capital

 

138,066,008

 

 

 

157,545,448

 

Accumulated deficit

 

(138,287,022

)

 

 

(150,619,048

)

Total shareholders’ equity/(deficit)

 

(220,569

)

 

 

6,928,277

 

Total liabilities and shareholders’ equity/(deficit)

$

6,565,053

 

 

$

14,196,386

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

4


Biocept, Inc.

Condensed Statements of Operations and Comprehensive Loss

(Unaudited)

 

 

For the three months ended September 30,

 

 

For the nine months ended September 30,

 

 

2014

 

 

2015

 

 

2014

 

 

2015

 

Revenues:

$

10,274

 

 

$

164,856

 

 

$

57,794

 

 

$

391,626

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenues

 

538,181

 

 

 

1,159,710

 

 

 

1,555,861

 

 

 

3,320,467

 

Research and development expenses

 

1,310,905

 

 

 

677,729

 

 

 

3,427,513

 

 

 

2,073,391

 

General and administrative expenses

 

1,060,812

 

 

 

1,630,608

 

 

 

3,970,579

 

 

 

4,281,883

 

Sales and marketing expenses

 

812,005

 

 

 

1,055,653

 

 

 

1,246,507

 

 

 

2,616,218

 

Total costs and expenses

 

3,721,903

 

 

 

4,523,700

 

 

 

10,200,460

 

 

 

12,291,959

 

Loss from operations

 

(3,711,629

)

 

 

(4,358,844

)

 

 

(10,142,666

)

 

 

(11,900,333

)

Other income/(expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

(151,491

)

 

 

(176,120

)

 

 

(1,640,045

)

 

 

(494,596

)

Change in fair value of warrant liability

 

3,326

 

 

 

558

 

 

 

(200,994

)

 

 

361

 

Other income

 

 

 

 

38,412

 

 

 

 

 

 

64,020

 

Total other income/(expense):

 

(148,165

)

 

 

(137,150

)

 

 

(1,841,039

)

 

 

(430,215

)

Loss before income taxes

 

(3,859,794

)

 

 

(4,495,994

)

 

 

(11,983,705

)

 

 

(12,330,548

)

Income tax expense

 

 

 

 

(199

)

 

 

(800

)

 

 

(1,478

)

Net loss & comprehensive loss

$

(3,859,794

)

 

$

(4,496,193

)

 

$

(11,984,505

)

 

$

(12,332,026

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

4,449,603

 

 

 

18,727,806

 

 

 

3,845,540

 

 

 

15,735,907

 

Diluted

 

4,449,603

 

 

 

18,727,806

 

 

 

3,845,540

 

 

 

15,735,907

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.87

)

 

$

(0.24

)

 

$

(3.12

)

 

$

(0.78

)

Diluted

$

(0.87

)

 

$

(0.24

)

 

$

(3.12

)

 

$

(0.78

)

 

 

 

 

 

 

 

 

 

 

 


 

 

 

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

 

5


Biocept, Inc.

Condensed Statements of Cash Flows

(Unaudited)

 

 

 

For the nine months ended September 30,

 

 

2014

 

 

2015

 

Cash Flows From Operating Activities:

 

 

 

 

 

 

 

Net loss

$

(11,984,505

)

 

$

(12,332,026

)

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

 

 

 

 

 

 

 

Depreciation and amortization

 

177,516

 

 

 

188,120

 

Inventory reserve

 

(9,616

)

 

 

(20,277

)

Stock-based compensation

 

1,506,586

 

 

 

1,016,266

 

Non-cash interest expense related to convertible debt, credit facility and other financing activities

 

1,428,324

 

 

 

93,454

 

Change in fair value of warrant liability

 

200,994

 

 

 

(361

)

Increase/(decrease) in cash resulting from changes in:

 

 

 

 

 

 

 

Accounts receivable

 

(3,245

)

 

 

(29,760

)

Inventory

 

(46,201

)

 

 

(93,000

)

Prepaid expenses and other current assets

 

(528,988

)

 

 

(181,284

)

Other non-current assets

 

500

 

 

 

 

Accounts payable

 

(992,399

)

 

 

142,028

 

Accrued liabilities

 

(1,177,510

)

 

 

218,829

 

Accrued interest

 

38,304

 

 

 

96,295

 

Deferred rent

 

33,238

 

 

 

5,614

 

Net cash used in operating activities

 

(11,357,002

)

 

 

(10,896,102

)

Cash Flows From Investing Activities:

 

 

 

 

 

 

 

Purchases of fixed assets

 

(201,835

)

 

 

(118,896

)

Net cash used in investing activities

 

(201,835

)

 

 

(118,896

)

Cash Flows From Financing Activities:

 

 

 

 

 

 

 

Net proceeds from issuance of common stock

 

17,390,240

 

 

 

8,830,057

 

Proceeds from exercise of common stock warrants

 

 

 

9,697,660

 

Payments on equipment financings

 

(9,300

)

 

 

(54,007

)

Payments on supplier and other third party financings

 

(163,411

)

 

 

(33,674

)

Payments on line of credit

 

(2,346,000

)

 

 

(247,701

)

Proceeds from borrowings on line of credit

 

365,000

 

 

 

 

Proceeds from issuance of convertible notes and warrants

 

175,000

 

 

 

 

Net proceeds from borrowings on credit facility and warrants

 

4,898,002

 

 

 

 

Net cash provided by financing activities

 

20,309,531

 

 

 

18,192,335

 

Net increase in Cash and Cash Equivalents

 

8,750,694

 

 

 

7,177,337

 

Cash and Cash Equivalents at Beginning of Period

 

69,178

 

 

 

5,364,582

 

Cash and Cash Equivalents at End of Period

$

8,819,872

 

 

$

12,541,919

 

Supplemental Disclosures of Cash Flow Information:

 

 

 

 

 

 

 

Cash paid during the period for:

 

 

 

 

 

 

 

         Interest

$

298,381

 

 

$

309,324

 

         Taxes

$

800

 

 

$

2,054

 

 

 

 

 

6


Non-cash Investing and Financing Activities:

During the nine months ended September 30, 2014, the Company replaced its private company directors and officers liability insurance policy financed during the year ended December 31, 2013 with a public company policy. The previously financed premium balance of $44,559 was cancelled and a partial refund of $10,955 was received.

During the nine months ended September 30, 2014, common stock warrants with an estimated aggregate grant date fair value of $135,222 were issued in conjunction with guarantees on the Company’s additional borrowings under its line of credit and additional borrowings made under its convertible notes issued in 2013, and were recorded as a discount to outstanding debt at the date of issuance.

An initial public offering (“IPO”) of the Company’s common stock was effected on February 5, 2014, the closing of which occurred on February 10, 2014 (see Note 2). On February 4, 2014, as contemplated by the registration statement covering the IPO, 69,421,047 shares of outstanding Series A Convertible Preferred Stock were automatically converted into 1,652,851 shares of common stock. In connection with the closing of the IPO on February 10, 2014, (i) the underwriters of the IPO were granted a 45 day option from the closing date to purchase up to 285,000 shares of common stock at $9.30 per share to cover overallotments with a grant date fair value of $202,143, which was recorded as an offset to additional paid-in capital within common stock issuance costs, (ii) certain designees of the representative of the underwriters were issued warrants to buy (in the aggregate) up to 95,000 shares of common stock at $12.50 per share with a term of five years and a grant date fair value of $544,116, and was recorded as an offset to additional paid-in capital within common stock issuance costs, (iii) underwriter IPO costs and discounts of $279,760 and $1,330,000, respectively, were netted against the proceeds from the IPO and are reflected as an offset to additional paid-in capital, (iv) the $1,400,000 principal amount and $233,982 of accrued interest related to the convertible note issued in 2008 were converted at $10.00 per share into a total of 163,399 shares of common stock, (v) the $5,165,000 principal amount and $313,017 of accrued interest related to the convertible notes issued in 2013 were converted at $10.00 per share into a total of 548,803 shares of common stock, (vi) derivative warrant liabilities of $2,475,620 associated with an aggregate of 387,152 common stock warrants related to the convertible notes issued in 2013 and line of credit were reclassified to additional paid-in capital when their underlying exercise price was fixed at $10.00 per share, and (vii) additional costs associated with the IPO of $932,136 were reclassified from prepaid expenses and other current assets to additional paid-in capital.

During the nine months ended September 30, 2014, a common stock warrant with an estimated grant date fair value of $233,107 was issued in conjunction with borrowings made under the Company’s April 2014 credit facility with Oxford Finance LLC (the “April 2014 Credit Facility”), and was recorded as a discount to outstanding debt at the date of issuance (see Note 6).

A public offering of the Company’s common stock and warrants to purchase its common stock was effected on February 9, 2015, the closing of which occurred on February 13, 2015 (see Note 2). In connection with the closing of this offering, (i) warrants were issued to buy (in the aggregate) up to 8,000,000 shares of common stock at a price of $1.56 per share with a term of five years and an estimated grant date fair value of $7,690,395 (see Note 4), which was recorded as an offset to additional paid-in capital within common stock issuance costs, (ii) the underwriters were granted a 45 day option from the closing date of the offering to purchase up to 1,200,000 additional shares of common stock at a price of $1.25 per share and/or additional warrants to purchase up to 1,200,000 shares of common stock at a price of $0.0001 per warrant, less underwriting discounts and commissions, to cover over-allotments, if any, with an aggregate estimated grant date fair value of $1,627,396 (see Note 4) that was recorded to common stock issuance costs, and (iii) costs of $63,111 directly associated with this offering that were included in prepaid expenses and other current assets at December 31, 2014 were reclassified to common stock issuance costs.

Fixed assets purchased totaling $4,775 and $3,190 during the nine months ended September 30, 2014 and 2015, respectively, were unpaid as of each reporting date, and are excluded from cash purchases in the Company’s unaudited condensed statements of cash flows.

Fixed assets purchased totaling $140,267 and $279,008 during the nine months ended September 30, 2014 and 2015, respectively, are recorded as equipment financing obligations and are excluded from cash purchases in the Company’s unaudited condensed statements of cash flows.

 

 

 

 

 

 

 

 

 

 

 

 

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

7


BIOCEPT, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

1. Basis of Presentation

Basis of Presentation

The financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the United States of America.

The unaudited condensed financial statements included in this Form 10-Q have been prepared in accordance with the U.S. Securities and Exchange Commission (“SEC”) instructions for Quarterly Reports on Form 10-Q. Accordingly, the condensed financial statements are unaudited and do not contain all the information required by U.S. Generally Accepted Accounting Principles (“GAAP”) to be included in a full set of financial statements. The balance sheet at December 31, 2014 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for a complete set of financial statements. The audited financial statements for the year ended December 31, 2014, filed with the SEC with our Annual Report on Form 10-K on March 11, 2015 include a summary of our significant accounting policies and should be read in conjunction with this Form 10-Q. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in this Form 10-Q. All such adjustments are of a normal recurring nature. The results of operations for interim periods are not necessarily indicative of the results of operations for the entire year.

Certain prior period amounts have been reclassified to conform to the current period presentation. Additionally, a total of $318,565 of revenue-generating costs previously allocated to research and development expenses during the six months ended June 30, 2015 were reclassified to cost of revenues in the current period presentation of the unaudited condensed statement of operations and comprehensive loss for the nine months ended September 30, 2015.

The Company and Business Activities

Biocept, Inc. (the “Company”) was founded in California in May 1997 and is a commercial-stage cancer diagnostics company developing and commercializing proprietary circulating tumor cell (“CTC”) and circulating tumor DNA (“ctDNA”) assays utilizing a standard blood sample to improve the treatment that oncologists provide to their patients by providing better, more detailed information on the characteristics of their tumor.

The Company operates a clinical laboratory that is CLIA-certified (under the Clinical Laboratory Improvement Amendment of 1988) and CAP-accredited (by the College of American Pathologists), and manufactures Cell Enrichment and Extraction (“CEE”) microfluidic channels, related equipment and certain reagents to perform the Company’s diagnostic assays in a facility located in San Diego, California. CLIA certification and accreditation are required before any clinical laboratory may perform testing on human specimens for the purpose of obtaining information for the diagnosis, prevention, treatment of disease, or assessment of health. The assays the Company offers are classified as laboratory developed tests under the CLIA regulations.

In July 2013, the Company effected a reincorporation to Delaware by merging itself with and into Biocept, Inc., a Delaware corporation, which had been formed to be and was a wholly-owned subsidiary of the Company since July 23, 2013.

Recent Accounting Pronouncements

In May 2014, the Financial Standards Accounting Board (the “FASB”) issued authoritative guidance that requires entities to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. This proposed guidance has been deferred and would be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Earlier application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period. The Company is currently in the process of evaluating the impact of the adoption of this guidance on its financial statements and disclosures.

In June 2014, the FASB issued authoritative guidance requiring share-based payments with a performance target which affects vesting and that could be achieved after the requisite service period be treated as a performance condition. This guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2015. The Company does not expect adoption of this guidance to have a material impact on its financial statements or disclosures.

8


In August 2014, the FASB issued authoritative g uidance requiring management to evaluate whether there are conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Certain addition al financial statement disclosures are required if such conditions or events are identified. This guidance is effective for the annual reporting period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early adoption is permitted. The Company is currently in the process of evaluating the impact of the adoption of this guidance on its financial statements and disclosures.

In April 2015, the FASB issued authoritative guidance requiring debt issuance costs to be presented in the balance sheet as a direct deduction from the associated debt liability. This guidance is effective on a retrospective basis for the annual reporting period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early adoption is permitted. The Company early adopted this guidance on a retrospective basis for the interim reporting period ended March 31, 2015. A balance of $23,194 of such costs were reclassified from other non-current assets, net to non-current portion of credit facility, net in the Company’s balance sheet as of December 31, 2014. A total of $15,093 of such costs remain unamortized and recorded as an offset to non-current portion of credit facility, net in the Company’s unaudited condensed balance sheet at September 30, 2015.

In July 2015, the FASB issued authoritative guidance requiring entities that do not measure inventory using the retail inventory method or on a last-in, first-out basis to record inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. This guidance is effective on a prospective basis for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. Early adoption is permitted. The Company does not expect adoption of this guidance to have a material impact on its financial statements or disclosures.

In August 2015, the FASB issued amendments to SEC paragraphs referenced in authoritative guidance around the presentation and subsequent measurement of debt issuance costs associated with line-of-credit arrangements. These amendments state that the SEC staff would not object to an entity deferring and presenting debt issuance costs as an asset and subsequently amortizing the deferred debt issuance costs ratably over the term of the line-of-credit arrangement, regardless of whether there are any outstanding borrowings on the line-of-credit arrangement. The Company’s adoption of these amendments upon issuance did not have a material impact on its financial statements or disclosures.

 

2. Public Offerings

Pursuant to an underwriting agreement dated February 4, 2014 between the Company and Aegis Capital Corp. (“Aegis”), as representative of the several underwriters named therein, an IPO of 1,900,000 shares of common stock at $10.00 per share was effected on February 5, 2014. The closing of the sale of these shares to the underwriters occurred on February 10, 2014. The Company received, after deducting underwriting discounts and additional costs paid to the underwriters, $17.4 million of net cash proceeds from the sale of these 1,900,000 shares. The total increase in capital as a result of the sale of these shares was $16.5 million after deducting $0.9 million of additional non-underwriter costs incurred that were netted against these proceeds under applicable accounting guidance. Additionally, the underwriters were granted a 45 day option from the closing date of the IPO to purchase up to 285,000 shares of common stock at $9.30 per share to cover overallotments with an estimated grant date fair value of $0.2 million, which was not exercised. In addition, designees of Aegis were issued warrants to buy (in the aggregate) up to 95,000 shares of common stock at $12.50 per share with a term of five years and an estimated grant date fair value of $0.5 million.

On February 4, 2014, as contemplated by the registration statement covering the IPO, 69,421,047 shares of outstanding Series A Convertible Preferred Stock with a par value of $0.0001 per share were converted into 1,652,851 shares of common stock and the Company’s certificate of incorporation was amended to provide for an authorized capitalization of 40,000,000 shares of common stock and 5,000,000 shares of preferred stock. There were no shares of preferred stock issued or outstanding as of December 31, 2014 or September 30, 2015.

In connection with the closing of the IPO on February 10, 2014, (i) the $1.4 million principal amount and $0.2 million of accrued interest related to the convertible note issued in 2008 were converted at $10.00 per share into a total of 163,399 shares of common stock, (ii) the $5.2 million principal amount and $0.3 million of accrued interest related to the convertible notes issued in 2013 were converted at $10.00 per share into a total of 547,794 shares of common stock, (iii) the exercise price of the warrants associated with the convertible notes issued in 2013 was fixed at $10.00 per share for an aggregate 258,249 shares of common stock, (iv) the exercise price of the warrants associated with the $2.6 million of collateral provided to secure the Company’s line of credit was fixed at $10.00 per share for an aggregate 128,903 shares of common stock, (v) 73,151 shares of common stock vested as settlement of certain restricted stock units (which were previously expressed in shares of preferred stock) and became issuable subsequent to the expiration of the 180 day lock-up period following the IPO, (vi) the Company’s Executive Chairman ceased to be an employee and continues to serve as non-executive Chairman, (vii) the number of shares of common stock covered by the Company’s 2013 Equity Incentive Plan increased by 800,000, (viii) all but 1,587 of the preferred warrants previously outstanding were canceled due to early termination clauses associated with the IPO, (ix) derivative warrant liabilities of $2.5 million associated with the aggregate of 387,152 common stock warrants related to the convertible notes issued in 2013 and line of credit were reclassified to additional paid-in capital when

9


their underlying exercise price was fixed, (x) unamor tized discounts of $ 1.0 million related to the warrants associated with the convertible notes issued in 2013 and line of credit were reclassified to interest expense, and (xi) offering costs associated with the IPO of $ 0.9 million were reclassified from pr epaid expenses and other current assets to additional paid-in capital, while additional underwriter IPO costs and discounts of $ 0.3 million and $1 .3 million , respectively, were netted against the proceeds from the IPO and are reflected as an offset to addi tional paid-in capital.

Subsequent to December 31, 2013, the maximum amount of the Company’s line of credit was increased to approximately $2.6 million and common stock warrants were issued to four shareholders in conjunction with their guarantees on the Company’s additional borrowings under the line of credit. On February 10, 2014, the current outstanding balance under the line of credit of approximately $2.3 million plus accrued interest of $27,043 was paid in full using the net proceeds from the IPO.

On February 13, 2014, the Compensation Committee of the Company’s Board of Directors approved payments of approximately $1.0 million for deferred salary obligations, including contractual interest, to current and former executive officers pursuant to previously existing agreements, which was fully disbursed by April 2014 using the net proceeds from the IPO. An additional $344,883 in deferred salary obligations and interest thereon was paid to former employees other than executive officers. Also on February 13, 2014, in connection with the closing of the IPO and pursuant to a director compensation policy adopted by the Company’s Board of Directors in 2013, the Company’s Board of Directors approved annual cash retainers to non-employee directors, and granted 238,500 stock options under the Company’s 2013 Equity Incentive Plan to non-employee directors. These option awards vest in equal annual installments over 3 years from the date of grant with a 10 year term, subject to continuing service requirements. Subsequently in February 2014, the Company’s Board of Directors approved grants of 54,298 stock options as a result of the closing of the IPO pursuant to the terms of underlying employment agreements. Included in the stock options granted pursuant to the terms of underlying employment agreements were 53,108 option awards granted to the Company’s non-executive Chairman, which vested fully on the date of grant.

Under the terms of certain employment agreements with executive officers, the Company incurred additional cash compensation expense of $150,000 immediately, and $225,000 annually, upon the closing of its IPO. All payments required under these agreements as a result of the closing of the IPO on February 10, 2014 were subsequently made in February and March 2014, using the net proceeds from the IPO.

During the year ended December 31, 2014, the Company repaid in full the remaining amounts outstanding of approximately $70,000 due for laboratory equipment under financing agreements with a supplier, which is a business owned by a member of the Company’s board of directors, using the net proceeds from the IPO.

Pursuant to an underwriting agreement dated February 9, 2015 between the Company, Aegis and Feltl and Company, as underwriters named therein, a public offering of 8,000,000 shares of the Company’s common stock and warrants to purchase up to an aggregate of 8,000,000 shares of common stock was effected at a combined offering price of $1.25. The estimated grant date fair value of these warrants of $7.7 million was recorded as an offset to additional paid-in capital within common stock issuance upon the closing of this offering (see Note 4). Each of the members of the Company’s Board of Directors participated in this offering, purchasing an aggregate 142,000 shares of the Company’s common stock and warrants to purchase up to an aggregate of 142,000 shares of its common stock for a total purchase price of $ 177,500 . All warrants sold in this offering have a per share exercise price of $1.56, are exercisable immediately and expire five years from the date of issuance. The closing of the sale of these securities to the underwriters occurred on February 13, 2015, when the Company received, after deducting underwriting discounts and additional costs paid to the underwriters, $9.1 million of net cash proceeds. The total increase in capital as a result of the sale of these shares and warrants was $8.8 million after deducting $0.3 million of additional non-underwriter costs incurred. Additionally, the underwriters were granted a 45-day option to purchase up to 1,200,000 additional shares of common stock at a price of $1.25 per share and/or additional warrants to purchase up to 1,200,000 shares of common stock at a price of $0.0001 per warrant, less underwriting discounts and commissions, to cover over-allotments, if any, which was not exercised. The estimated grant date fair value of the over-allotment options and warrants of $1.6 million was recorded as an offset to additional paid-in capital within common stock issuance costs upon the closing of this offering (see Note 4). Underwriter costs and discounts of $0.2 million and $0.7 million, respectively, as well as additional non-underwriter costs associated with the offering of $0.3 million, were also recorded to common stock issuance costs upon closing. Subsequent to the closing of this offering on February 13, 2015 and through November 2, 2015, additional cash proceeds of $9.8 million have been received from the exercise of warrants sold in such offering. As such, the aggregate total increase in capital related to this offering has been $18.6 million, after deducting $0.9 million of underwriter costs and discounts and $0.3 million of additional non-underwriter costs incurred, which were netted against these proceeds under applicable accounting guidance.

 

3. Liquidity & Going Concern Uncertainty

 

These unaudited condensed financial statements have been prepared and presented on a basis assuming the Company will continue as a going concern. The factors below raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.

10


At December 31, 2014 and September 30, 2015, the Company had accumulated deficits of $138.3 million and $ 150.6 million, respectively. For the year and nine month periods ended December 31, 2014 and September 30, 2015, the Company incurred net losses of $15.9 million and $ 12.3 million, respectively. The Company borr owed a total of $0.5 million during the year ended December 31, 2014 under note agreements with certain shareholders and a line of credit. In addition, the Company borrowed $5.0 million during the year ended December 31, 2014 under a credit facility entere d into in April 2014. While the Company is currently in the commercialization stage of operations, the Company has not yet achieved profitability and anticipates that it will continue to incur net losses in the foreseeable future.

Historically, the Company’s principal sources of cash have included proceeds from the issuance of common and preferred stock, proceeds from the exercise of warrants to purchase common stock, proceeds from the issuance of debt, and revenues from clinical laboratory testing through contracted partners. The Company’s principal uses of cash have included cash used in operations, payments relating to purchases of property and equipment and repayments of borrowings. The Company expects that the principal uses of cash in the future will be for continuing operations, hiring of sales and marketing personnel and increased sales and marketing activities, funding of research and development, capital expenditures, and general working capital requirements. The Company expects that, as revenues grow, sales and marketing and research and development expenses will continue to grow, albeit at a slower rate and, as a result, the Company will need to generate significant net revenues to achieve and sustain income from operations.

As of September 30, 2015, cash and cash equivalents totaled $12.5 million. On February 13, 2015, the Company received net cash proceeds of $9.1 million as a result of the closing of a follow-on public offering, before deducting $0.3 million of additional non-underwriting costs incurred. Subsequent to the closing of the follow-on public offering on February 13, 2015 and through November 2, 2015, additional cash proceeds of $9.8 million have been received from the exercise of warrants sold in such offering. Management expects that the Company will need additional financing in the future to execute on its current or future business strategies beyond June 2016. Until the Company can generate significant cash from operations, including assay revenues, the Company expects to continue to fund its operations with the proceeds from offerings of the Company’s equity securities or debt, or transactions involving product development, technology licensing or collaboration. Management can provide no assurances that any sources of a sufficient amount of financing will be available to the Company on favorable terms, if at all.

In May 2015, the SEC declared effective a shelf registration statement filed by the Company. The shelf registration statement allows the Company to issue any combination of its common stock, preferred stock, debt securities and warrants from time to time for an aggregate initial offering price of up to $50 million, subject to certain limitations for so long as the Company’s public float is less than $75 million. As of September 30, 2015, the Company had not sold any securities under this shelf registration statement.  The specific terms of future offerings, if any, under this shelf registration statement would be established at the time of such offerings.

 

4. Fair Value Measurement

The Company uses a three-tier fair value hierarchy to prioritize the inputs used in the Company’s fair value measurements. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets for identical assets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. The Company believes the carrying amount of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses, other than warrant liability, approximate their estimated fair values due to the short-term maturities of these financial instruments. The estimated fair value of the Company’s credit facility at September 30, 2015 approximated carrying value, which was determined using a discounted cash flow analysis. The analysis considered interest rates of instruments with similar maturity dates, which involved the use of significant unobservable Level 3 inputs.

11


In connection with the closing of the Company’s public offering on February 13, 2015, warrants were issued to buy (in the aggregate) up to 8,000,000 shares of common stock with an estimated grant date fair value of $ 7,690,395 , which was recorded as an offset to additional paid-in capital within common stock issuance costs. Also in connection with the closing of the Company’s follow-on public offering on February 13, 2015, th e underwriters were granted a 45 day option from the closing date of the offering to purchase up to 1,200,000 additional shares of common stock at a price of $1.25 per share and/or additional warrants to purchase up to 1,200,000 shares of common stock at a price of $0.0001 per warrant, less underwriting discounts and commissions, to cover over-allotments, if any. The estimated aggregate grant date fair value of these over-allotment options and warrants of $ 1,627,3 96 was also recorded to common stock issuanc e costs as a component of additional paid-in capital . The fair values of these over-allotment option s and all common stock warrants issued in this offering were estimated using Black-Scholes valuation models with the following assumptions:

 

 

Over-allotment Options

 

 

Warrants

 

Stock price

$

1.41

 

 

$

1.41

 

Exercise price

$

1.25

 

 

$

1.56

 

Expected dividend yield

 

0.00

%

 

 

0.00

%

Discount rate-bond equivalent yield

 

0.02

%

 

 

1.53

%

Expected life (in years)

 

0.12

 

 

 

5.00

 

Expected volatility

 

168.1

%

 

 

90.0

%

 

5. Balance Sheet Details

The following provides certain balance sheet details:

 

 

December 31,

 

 

September 30,

 

 

2014

 

 

2015

 

Fixed Assets

 

 

Machinery and equipment

$

2,922,303

 

 

$

2,997,676

 

Furniture and office equipment

 

209,844

 

 

 

212,659

 

Computer equipment and software

 

681,508

 

 

 

756,365

 

Leasehold improvements

 

506,328

 

 

 

514,614

 

Financed equipment

 

878,447

 

 

 

1,157,455

 

Construction in process

 

72,172

 

 

 

12,739

 

 

 

5,270,602

 

 

 

5,651,508

 

Less accumulated depreciation and amortization

 

4,608,180

 

 

 

4,796,300

 

Total fixed assets, net

$

662,422

 

 

$

855,208

 

Accrued Liabilities

 

 

 

 

 

 

 

Accrued interest

$

33,125

 

 

$

31,484

 

Accrued payroll

 

82,241

 

 

 

216,154

 

Accrued vacation

 

276,574

 

 

 

286,125

 

Accrued bonuses

 

302,763

 

 

 

286,557

 

Accrued sales commissions

 

 

 

 

63,167

 

Warrant liability

 

1,070

 

 

 

709

 

Other

 

4,130

 

 

 

32,534

 

Total accrued liabilities

$

699,903

 

 

$

916,730

 

 

6. April 2014 Credit Facility

On April 30, 2014, the Company received net cash proceeds of approximately $4,927,000 pursuant to the execution of its April 2014 Credit Facility with Oxford Finance LLC.  A second term loan of up to a principal amount of $ 5 million will be funded at the Company’s request prior to December 31, 2015, subject to the achievement of product and services revenues of at least $ 9 million for the trailing six months, with such six-month period ending no later than November 30, 2015. Upon the entry into the April 2014 Credit Facility, the Company was required to pay the lenders a facility fee of $ 50,000 in conjunction with the funding of the first term loan. Another $50, 000 facility fee will be due and payable to the lenders on the funding date of the second term loan (if such date occurs). The April 2014 Credit Facility is secured by substantially all of the Company’s personal property other than its intellectual property. Each term loan under the April 2014 Credit Facility bears interest at an annual rate equal to the greater of (i) 7.95 % or (ii) the sum of (a) the three-month U.S. LIBOR rate reported in the Wall Street Journal three business days prior to the funding date of the applicable term loan, plus (b) 7.71 %, such rate to be fixed at the time of borrowing. The first term loan bears interest at an annual rate

12


of 7.95 %. The Company was required to make interest-only payments on the first term loan through August 1, 2015. If the Company request s and the lenders fund the second term loan, the Company is required to make interest-only p ayments on the second term loan through the seventh month following the funding date o f the second term loan . All outstanding term loans under the April 2014 Credit Facility will begin amortizing at the end of the applicable interest-only period, with monthly payments of principal and interest being made by the Company to the lenders in consecutive monthly installments following such interest-only period. The first t erm loan under the April 2014 Credit Facility matures on July 1, 2018, and the second term loan matures on the first day of the 29th month following the end of the applicable interest-only period. Upon repayment of each term loan, the Company is also requi red to make a final payment to the lenders equal to 5.5 % of the original principal amou nt of such term loan funded. At its option, the Company may prepay the outstanding principal balance of the term loans in whole but not in part, subject to a prepayment fee of 2 % of the amount prepaid if the prepayment occurs prior to April 30, 2016, and 1 % of any amount prepaid after April 30, 2016.

The April 2014 Credit Facility includes affirmative and negative covenants applicable to the Company and any subsidiaries the Company creates in the future. The affirmative covenants include, among others, covenants requiring the Company to maintain its legal existence and governmental approvals, deliver certain financial reports and maintain insurance coverage. The negative covenants include, among others, restrictions on the Company’s transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets, and suffering a change in control, in each case subject to certain exceptions. The April 2014 Credit Facility also includes events of default, the occurrence and continuation of which provide Oxford Finance LLC, as collateral agent, with the right to exercise remedies against the Company and the collateral securing the term loans under the April 2014 Credit Facility, including foreclosure against the Company’s properties securing the April 2014 Credit Facility, including the Company’s cash. These events of default include, among other things, the Company’s failure to pay any amounts due under the April 2014 Credit Facility, a breach of covenants under the April 2014 Credit Facility, the Company’s insolvency, a material adverse change, the occurrence of any default under certain other indebtedness in an amount greater than $250,000, and a final judgment against the Company in an amount greater than $ 250,000 .

A warrant to purchase up to 52,966 shares of the Company’s common stock at an exercise price of $4.72 per share with a term of 10 years was issued to Oxford Finance LLC on April 30, 2014. The estimated fair value of the warrant issued of $233,107 was recorded as a discount to outstanding debt as of the closing date. Additional warrants to purchase shares of the Company’s common stock will be issued upon execution of the second term loan under the April 2014 Credit Facility in an amount equal to 5.0% of the funded amount divided by the exercise price, which will be equal to the lower of (i) the closing price per share of the Company’s common stock on the NASDAQ on the date prior to the funding date of the second term loan or (ii) the ten-day average closing price per share prior to the funding date of the second term loan. The effective annual interest rate associated with the April 2014 Credit Facility was 10.81% at December 31, 2014 and 11.50% at September 30, 2015.

 

7. Stock-based Compensation

Equity Incentive Plans

On January 1, 2015, the number of shares of common stock covered by the Company’s 2013 Equity Incentive Plan automatically increased by 222,480 shares, or 5% of the number of common shares then outstanding, to a total of 1,426,051 shares. At the Company’s annual meeting of stockholders held on June 16, 2015, the stockholders approved the Company’s Amended and Restated 2013 Equity Incentive Plan (“2013 Plan”), which included (i) an increase in the number of shares of common stock authorized for issuance under the 2013 Plan by 1,500,000 shares, and (ii) a provision that shares available for grant under the Company’s 2007 Equity Incentive Plan (“2007 Plan”) become available for issuance under the 2013 Plan and are no longer available for issuance under the 2007 Plan. As of September 30, 2015, under all plans, a total of 3,104,622 shares were authorized for issuance, 2,131,603 stock options and restricted stock units (“RSUs”) had been issued and were outstanding, and 836,082 shares were available for grant.

13


Stock Options

A summary of stock option activity for option awards granted under the 2013 Plan and 2007 Plan for the nine months ended September 30, 2015 is as follows:

 

 

 

 

 

 

 

 

 

 

Average

 

 

 

 

 

 

Weighted

 

 

Remaining

 

 

Number of

 

 

Average Exercise

 

 

Contractual

 

 

Shares

 

 

Price Per Share

 

 

Term in Years

 

Vested and unvested expected to vest, December 31, 2014

 

901,882

 

 

$

6.28

 

 

8.9

 

Outstanding at December 31, 2014

 

906,194

 

 

$

6.29

 

 

9.0

 

Granted

 

1,194,871

 

 

$

2.07

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

Cancelled/forfeited/expired

 

(46,727

)

 

$

4.33

 

 

 

 

 

Outstanding at September 30, 2015

 

2,054,338

 

 

$

3.88

 

 

 

9.1

 

Vested and unvested expected to vest, September 30, 2015

 

1,899,759

 

 

$

4.01

 

 

 

9.0

 

The intrinsic values of options outstanding and options vested and unvested expected to vest at September 30, 2015 were $313,095 and $287,631, respectively.

The fair values of option awards granted during the nine months ended September 30, 2015 were estimated using a Black-Scholes pricing model with the following assumptions:

 

Stock and exercise prices

$2.01 - $3.38

 

Expected dividend yield

 

0.00

%

Discount rate-bond equivalent yield

1.52% – 1.93%

 

Expected life (in years)

5.23 – 6.08

 

Expected volatility

70.0% – 100.0%

 

Using the assumptions described above, with stock and exercise prices being equal on date of grant, the weighted-average estimated fair value of options granted in the nine months ended September 30, 2015 was $1.35 per share.

On August 31, 2015, the Company’s Board of Directors approved the issuance of 100,000 stock options with an estimated grant date fair value of $1.47 per share to its Chief Executive Officer pursuant to the 2013 Plan. Vesting of these stock options may occur based on the Company’s achievement of specified objectives as determined by the Company’s Board of Directors, or a committee of the Company’s Board of Directors in its sole discretion, as follows:

 

 

Percentage of

 

 

Overall Stock

 

 

Option Grant

 

 

Subject to Vesting

 

Target

 

 

 

Minimum number of accessions processed, billed and collected

     in fiscal 2016

 

25

%

Minimum revenues from contracts with pharmaceutical

     companies in fiscal 2016

 

20

%

Attainment of a sustainable positive GAAP gross margin by

     December 31, 2016

 

25

%

Minimum operating cash on-hand at December 31, 2016, with

     no more than one interim dilutive equity financing event

 

30

%

Total

 

100

%

14


Further information about the options outstanding and exercisable at September 30, 2015 is as follows:

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

Weighted

 

 

 

 

 

 

Average

 

 

 

 

 

Average

 

 

Total Shares

 

 

Contractual

 

 

Total Shares

 

Exercise Price

 

 

Outstanding

 

 

Life (in years)

 

 

Exercisable

 

$

2.01

 

 

 

1,079,637

 

 

 

9.9

 

 

 

-

 

$

2.65

 

 

 

152,734

 

 

 

9.6

 

 

 

1,000

 

$

4.51

 

 

 

79,526

 

 

 

8.0

 

 

 

46,192

 

$

5.12

 

 

 

406,643

 

 

 

8.1

 

 

 

297,977

 

$

7.50

 

 

 

43,000

 

 

 

8.5

 

 

 

16,125

 

$

8.88

 

 

 

238,500

 

 

 

8.4

 

 

 

79,497

 

$

9.11

 

 

 

54,298

 

 

 

8.4

 

 

 

54,298

 

 

 

 

 

 

2,054,338

 

 

 

 

 

 

 

495,089

 

The intrinsic value of options exercisable at September 30, 2015 was zero.

Restricted Stock

At September 30, 2015, there were 150,418 RSUs outstanding, of which 121,829 shares were vested and unvested expected to vest. The intrinsic values of RSUs outstanding and RSUs vested and unvested expected to vest at September 30, 2015 were $345,961 and $280,207, respectively.

Stock-based Compensation Expense

The following table presents the effects of stock-based compensation related to equity awards to employees and nonemployees on the unaudited condensed statement of operations and comprehensive loss during the periods presented:

 

 

For the three months ended

 

 

For the nine months ended

 

 

September 30,

 

 

September 30,

 

 

2014

 

 

2015

 

 

2014

 

 

2015

 

Stock Options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenues

$

-

 

 

$

15,029

 

 

$

-

 

 

$

48,839

 

Research and development expenses

 

35,569

 

 

 

20,910

 

 

 

149,626

 

 

 

65,835

 

General and administrative expenses

 

236,769

 

 

 

257,404

 

 

 

908,490

 

 

 

706,026

 

Sales and marketing expenses

 

27,834

 

 

 

31,888

 

 

 

46,762

 

 

 

93,989

 

Total expenses related to stock options

 

300,172

 

 

 

325,231

 

 

 

1,104,878

 

 

 

914,689

 

RSUs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

7,500

 

 

 

1,625

 

 

 

22,500

 

 

 

10,724

 

General and administrative expenses

 

13,750

 

 

 

12,515

 

 

 

379,208

 

 

 

90,853

 

Total stock-based compensation

$

321,422

 

 

$

339,371

 

 

$

1,506,586

 

 

$

1,016,266

 

 

Stock-based compensation expense was recorded net of estimated forfeitures of 0% - 5% and 0% - 4% per annum during the three and nine months ended September 30, 2014 and 2015, respectively. As of September 30, 2015 total unrecognized stock-based compensation expense related to unvested stock option and RSU awards, adjusted for estimated forfeitures, was approximately $2,993,000 and $17,000, respectively, and is expected to be recognized over a weighted-average period of 2.7 years and 0.3 years, respectively.

 

8. Common Warrants Outstanding

A summary of equity-classified common stock warrant activity for the nine months ended September 30, 2015 is as follows:

 

15


 

 

 

 

 

 

 

 

 

Average

 

 

 

 

 

 

Weighted

 

 

Remaining

 

 

Number of

 

 

Average Exercise

 

 

Contractual

 

 

Shares

 

 

Price Per Share

 

 

Term in Years

 

Outstanding at December 31, 2014

 

609,187

 

 

$

9.93

 

 

 

3.8

 

Issued

 

9,200,000

 

 

$

1.56

 

 

 

 

 

Exercised

 

(6,216,449

)

 

$

1.56

 

 

 

 

 

Expired

 

(1,200,000

)

 

$

1.56

 

 

 

 

 

Outstanding at September 30, 2015

 

2,392,738

 

 

$

3.69

 

 

 

4.0

 

Further information about equity-classified common stock warrants outstanding and exercisable at September 30, 2015 is as follows:

 

 

 

 

 

 

 

 

 

Weighted

 

Weighted

 

 

 

 

 

 

Average

 

Average

 

 

Total Shares

 

 

Contractual

 

Exercise Price

 

 

Outstanding

 

 

Life (in years)

 

$

1.56

 

 

 

1,783,551

 

 

 

4.4

 

$

4.72

 

 

 

52,966

 

 

 

8.6

 

$

10.00

 

 

 

461,221

 

 

 

2.4

 

$

12.50

 

 

 

95,000

 

 

 

3.4

 

 

 

 

 

 

2,392,738

 

 

 

 

 

The intrinsic value of equity-classified common stock warrants outstanding and exercisable at September 30, 2015 was $1,319,828.

 

9. Net Loss per Common Share

Basic and diluted net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted-average common shares outstanding during the period. Because there is a net loss attributable to common shareholders for the three and nine months ended September 30, 2014 and 2015, the outstanding RSUs, warrants, and common stock options have been excluded from the calculation of diluted loss per common share because their effect would be anti-dilutive. Therefore, the weighted-average shares used to calculate both basic and diluted loss per share are the same.

The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding for the periods presented, as they would be anti-dilutive:

 

 

 

For the three and nine months ended

 

 

September 30,

 

 

2014

 

 

2015

 

Preferred warrants outstanding (number of common stock

     equivalents)

 

1,587

 

 

 

1,587

 

Preferred share RSUs (number of common stock equivalents)

 

73,151

 

 

 

73,151

 

Common warrants outstanding

 

609,187

 

 

 

2,392,738

 

Common share RSUs

 

178,467

 

 

 

77,267

 

Common options outstanding

 

875,042

 

 

 

2,054,338

 

Total anti-dilutive common share equivalents

 

1,737,434

 

 

 

4,599,081

 

 

10. Commitments and Contingencies

In the normal course of business, the Company may be involved in legal proceedings or threatened legal proceedings. The Company is not party to any legal proceedings or aware of any threatened legal proceedings that are expected to have a material adverse effect on its financial condition, results of operations or liquidity.

The Company’s former Vice President of Operations filed an administrative proceeding against the Company with the California Labor Commissioner in April 2013, seeking damages for alleged unpaid wages and penalties. A hearing was held on August 19, 2013 which resulted in a finding against the Company for approximately $65,000, of which $40,000 was paid during the year ended December 31, 2013 and $25,000 was accrued as of December 31, 2013. On February 25, 2014, the aforementioned administrative proceeding filed with the California Labor Commissioner by the Company’s former Vice President of Operations was settled in full following payment of the remaining $25,000 due.

16


 

11. Related Party Transactions

Each of the members of the Company’s Board of Directors participated in its public offering in February 2015, purchasing an aggregate of 142,000 shares of the Company’s common stock and warrants to purchase up to an aggregate of 142,000 shares of its common stock for a total purchase price of $177,500 (see Note 2).

Pursuant to a sublease agreement dated March 30, 2015, the Company rented 9,849 square feet, plus free use of an additional area, of its San Diego facility to an entity affiliated with the Company’s non-executive Chairman for $12,804 per month, with a refundable security deposit of $12,804 due from the subtenant. The initial term of the sublease expired on July 31, 2015, and is subject to renewal on a month-to-month basis thereafter.

A member of the Company’s management is the controlling person of Aegea Biotechnologies, Inc. (“Aegea”). On September 2, 2012, the Company entered into an Assignment and Exclusive Cross-License Agreement (the “Cross-License Agreement”) with Aegea. The Company received payments totaling $25,763 from Aegea as reimbursements for shared patent costs under the Cross-License Agreement.

The Company believes that these transactions were on terms at least as favorable to the Company as could have been obtained from unrelated third parties.


17


I tem 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2014 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission on March 11, 2015. Past operating results are not necessarily indicative of results that may occur in future periods.

We are an early-stage molecular oncology diagnostics company that develops and commercializes proprietary circulating tumor cell (“CTC”) and circulating tumor DNA (“ctDNA”) assays utilizing a standard blood sample, or “liquid biopsy.” Our current breast, lung and gastric cancer assays provide, and our planned future assays would provide, information to oncologists and other physicians that enable them to select appropriate personalized treatment for their patients based on better, timelier and more-detailed data on the characteristics of their patients’ tumors.

Our current breast, lung and gastric cancer assays and our planned future assays utilize our CEE technology for the enumeration and analysis of CTCs, and our Target-Selector TM technology for the detection and analysis of ctDNA from plasma, each performed on a standard blood sample. The CEE technology is an internally developed and patented, microfluidics-based CTC capture and analysis platform, with enabling features that change how CTC testing can be used by clinicians by providing real-time biomarker monitoring with only a standard blood sample. The Target-Selector technology enables mutation detection with enhanced sensitivity and specificity and is applicable to nucleic acid from CTCs or other sample types, such as blood plasma for ctDNA. We believe the Target-Selector technology could someday be used as a stand-alone test for molecular biomarkers, screening and monitoring.

At our corporate headquarters facility located in San Diego, California, we operate a clinical laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and accredited by the College of American Pathologists. We manufacture our CEE microfluidic channels, related equipment and certain reagents to perform our current assays and our planned future assays at this facility. CLIA certification is required before any clinical laboratory, including ours, may perform testing on human specimens for the purpose of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of health. The assays we offer and intend to offer are classified as laboratory developed tests under CLIA regulations.

We are continuing to commercialize our first assays: OncoCEE-BR TM for breast cancer, OncoCEE-LU TM for both non-small cell lung cancer (“NSCLC”) and small cell lung cancer (“SCLC”), OncoCEE-ME TM for melanoma, and OncoCEE-GA TM for gastric cancer. These assays utilize our CEE technology platform and provide CTC enumeration as well as biomarker analysis from a standard blood sample. In the case of the OncoCEE-BR and OncoCEE-GA assays, biomarker analysis involves fluorescence in situ hybridization (“FISH”) for the detection and quantitation of the human epidermal growth factor receptor 2 (“HER2”) gene copy number as well as immunocytochemical analysis of estrogen receptor (“ER”) protein, which is currently commercially available. We plan to include immunocytochemical analysis of progesterone receptor proteins in the OncoCEE-BR assay during 2015. A patient’s HER2 status provides the physician with information about the appropriateness of therapies such as Herceptin® or Tykerb®. Estrogen receptor and progesterone receptor (“PR”) status provides the physician with information about the appropriateness of endocrine therapies such as tamoxifen and aromatase inhibitors.

The OncoCEE-LU assay’s biomarker analysis currently includes FISH testing for ALK and ROS1 gene rearrangements and mutation analysis of the T790M, Deletion 19, and L858R mutations of the epidermal growth factor receptor (“EGFR”) gene as well as B-RAF and K-RAS using our Target-Selector platform. We plan to add FISH testing for RET gene analysis. The L858R mutation of the EGFR gene and Exon 19 deletions as activators of EGFR kinase activity are linked to the drugs Tarceva®, Gilotrif® and Iressa®. The codon 12 and 13 mutations of the K-RAS gene are found in patients whose tumors are unlikely to respond to the EGFR kinase inhibitors such as Erbitux® and Vectibix®. Our OncoCEE-LU assay is performed on a standard blood sample.

For lung cancer, we also offer a resistance panel assay consisting of the biomarkers MET, HER2 (both of which we perform using our OncoCEE technology for CTCs) and T790M which is performed using Target-Selector in plasma. This assay could be used by physicians to identify the mechanism causing disease progression for patients with NSCLC who are being treated with TKI therapy and therefore could qualify for inclusion in a clinical trial.

Fibroblast growth receptor 1 (“FGFR1”) amplification is offered for CTC testing utilizing our OncoCEE technology.  FGFR1 is present in several tumor types, including both NSCLC and SCLC and has been shown to be a prognostic indicator of progression. FGFR1 is also a key target for many drugs which are in clinical development.

Mutations of the B-RAF gene are linked to Zelboraf® and Tafinlar®, which are both approved for melanoma and are in clinical trials for lung cancer.  We offer testing for B-RAF on blood using our CEE-Selector platform.

18


We plan to add other biomarker analyses on bl ood samples to our current assays and our planne d future OncoCEE assays as their relevance is demonstrated in clinical trials, for example, RET proto-oncogene gene fusions in NSCLC, which may indicate a partic u lar course of therapy, and N-RAS genes for melanoma, which may predict therapy resistance. In addition, we are developing a ser ies of other CTC and ctDNA assays for different solid tumor types, including colorectal cancer, prostate cancer, gastric cancer and melanoma, each incorporating treatment-associated biomarker analyses specific to that cance r, planned to be launched as noted in the table below.

Assay Name/ Solid Tumor Type

 

Biomarkers

 

Status of Assay or
Project

 

Actual or Targeted Quarter
of Availability for
Commercialization

OncoCEE-BR / Breast Cancer

 

Enumeration, HER2 by FISH

 

Currently available

 

Launched 2011 Q3

 

 

 

 

 

 

 

 

 

ER

 

Currently available

 

Launched 2014 Q2

 

 

 

 

 

 

 

 

 

FGFR by FISH

 

Currently available

 

Launched 2015 Q3

 

 

 

 

 

 

 

 

 

PR

 

Validation

 

2015 Q4

 

 

 

 

 

 

 

 

 

ESR1

 

Development

 

2016 Q1

 

 

 

 

 

 

 

OncoCEE-LU / Lung Cancer

 

Enumeration, ALK

 

Currently available

 

Launched 2014 Q4

 

 

 

 

 

 

 

 

 

ROS1 by FISH

 

Currently available

 

Launched 2015 Q1

 

 

 

 

 

 

 

 

 

T790M, L858R and Del19 EGFR mutations

 

Currently available

 

Launched 2015 Q1

 

 

 

 

 

 

 

 

 

MET by FISH

 

Currently available

 

Launched 2015 Q2

 

 

 

 

 

 

 

 

 

FGFR by FISH

 

Currently available

 

Launched 2015 Q3

 

 

 

 

 

 

 

 

 

B-RAF by Target-Selector

 

Currently available

 

Launched 2015 Q3

 

 

 

 

 

 

 

 

 

K-RAS by Target-Selector

 

Currently available

 

Launched 2015 Q3

 

 

 

 

 

 

 

 

 

ALK mutations by Target-Selector

 

Development and Validation

 

2016 Q2

 

 

 

 

19


Assay Name/ Solid Tumor Type

 

Biomarkers

 

Status of Assay or
Project

 

Actual or Targeted Quarter
of Availability for
Commercialization

OncoCEE-GA / Gastric Cancer

 

Enumeration, HER2, MET by FISH

 

Currently available

 

Launched 2015 Q2

 

 

 

 

 

 

 

OncoCEE-CR TM / Colorectal Cancer

 

Enumeration

 

Currently available

 

Launched 2015 Q3

 

 

 

 

 

 

 

 

 

B-RAF by Target-Selector

 

Currently available

 

Launched 2015 Q3

 

 

 

 

 

 

 

 

 

K-RAS by Target-Selector

 

Currently available

 

Launched 2015 Q3

 

 

 

 

 

 

 

OncoCEE-PR TM / Prostate Cancer

 

Enumeration

 

Currently available

 

Launched 2011 Q3

 

 

 

 

 

 

 

 

 

PTEN deletion by FISH and AR by ICC

 

Development and Validation

 

2015 Q4

 

 

 

 

 

 

 

OncoCEE-ME TM / Melanoma

 

B-RAF by Target-Selector

 

Currently available

 

Launched 2015 Q3

 

 

 

 

 

 

 

 

 

Enumeration

 

Development

 

2015 Q4

 

 

 

 

 

 

 

 

 

PDL-1 by ICC

 

Validation

 

2015 Q4

 

 

 

 

 

 

 

 

 

N-RAS mutations by Target-Selector

 

Development

 

2016 Q2

 

 

 

 

 

 

 

CEE-Selector / Next Generation Sequencing application for multiple cancer types

 

K-RAS, B-RAF, EGFR and other mutations detected in plasma.

 

Development

 

2016 Q1/Q2

Our revenue generating efforts are focused in three areas:

 

·

providing clinical testing that oncologists use in order to determine the best treatment plan for their patients;

 

·

providing clinical trial, research and development services to biopharma companies developing cancer therapies; and

 

·

licensing our proprietary testing and/or technologies to partners in the United States and abroad.

We accessioned 482 commercial cases during the three months ended September 30, 2015 as compared to 96 commercial cases for the same period in 2014, an increase of 386 cases, or 402%. We accessioned 1,065 commercial cases during the nine months ended September 30, 2015 as compared to 110 commercial cases for the same period in 2014, an increase of 955 cases, or 868%. Revenues from commercial cases are recognized as collected, and the expected collection period for a commercial case often extends beyond the end of the quarter in which accessioned, with multiple payments received per case. For all cases accessioned, the minimum amount expected to be collected is based upon the applicable reimbursement rate according to either the Medicare Physician Fee Schedule or Clinical Lab Fee Schedule. Currently, Medicare reimbursement rates for our assays range from approximately $370 per case for enumeration-only samples without biomarker assays to over $1,700 per case for lung cancer samples with all biomarker assays. For cases accessioned during the first nine months of 2015, we estimate that the weighted-average amount expected to be collected will range from approximately $750 to $800 per case, depending on the mix of biomarker assays performed in each sample, although such reimbursement experience has not yet been achieved. Relatively higher reimbursement rates are expected to be achieved for cases billed to private payers.


20


Results of Operations

Three Months Ended September 30, 2014 and 2015

The following table sets forth certain information concerning our results of operations for the periods shown:

 

 

Three Months Ended September 30,

 

 

Change

 

 

2014

 

 

2015

 

 

$

 

 

%

 

(dollars in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

$

10