Biocept Inc.
BIOCEPT INC (Form: 10-Q, Received: 11/14/2014 16:19:22)

 

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, 2014

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 10, 2014, there were 4,449,603 shares of the Registrant’s common stock outstanding.

 

 

 

 

 


BIOCEPT, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED

September 30, 2014

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, 2013 and September 30, 2014 (unaudited)

  

4

 

 

 

 

 

Condensed Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2013 and 2014 (unaudited)

  

5

 

 

 

 

 

Condensed Statements of Cash Flows for the nine months ended September 30, 2013 and 2014 (unaudited)

  

6

 

 

 

 

 

Notes to Condensed Financial Statements (unaudited)

  

8

 

 

 

Item 2.

 

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

  

17

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

  

23

 

 

 

Item 4.

 

Controls and Procedures

  

24

 

 

 

PART II.

 

OTHER INFORMATION

  

 

 

 

 

Item 1A.

 

Risk Factors

  

25

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

  

25

 

 

 

Item 3.

 

Defaults Upon Senior Securities

  

25

 

 

 

Item 4.

 

Mine Safety Disclosures

  

25

 

 

 

Item 5.

 

Other Information

  

25

 

 

 

Item 6.

 

Exhibits

  

25

 

 

 

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” 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, or 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


PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

Biocept, Inc.

Condensed Balance Sheets

 

 

December 31,

 

 

September 30,

 

 

2013

 

 

2014

 

 

 

 

 

 

(unaudited)

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

69,178

 

 

$

8,819,872

 

Accounts receivable

 

9,200

 

 

 

12,445

 

Inventories, net

 

92,823

 

 

 

148,640

 

Prepaid expenses and other current assets

 

799,131

 

 

 

340,469

 

Total current assets

 

970,332

 

 

 

9,321,426

 

Fixed assets, net

 

358,887

 

 

 

528,248

 

Other non-current assets, net

 

500

 

 

 

25,365

 

Total assets

$

1,329,719

 

 

$

9,875,039

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

1,540,618

 

 

$

552,994

 

Accrued liabilities

 

2,242,058

 

 

 

580,602

 

Line of credit

 

1,981,000

 

 

 

 

Notes payable, net

 

5,200,599

 

 

 

 

Warrant liability

 

2,140,532

 

 

 

1,128

 

Supplier financings

 

218,925

 

 

 

 

Current portion of equipment financing

 

 

 

55,800

 

Total current liabilities

 

13,323,732

 

 

 

1,190,524

 

Non-current portion of equipment financing, net

 

 

 

78,933

 

Credit facility, net

 

 

 

4,731,541

 

Non-current interest payable

 

 

 

33,905

 

Deferred rent

 

462,001

 

 

 

495,239

 

Total liabilities

 

13,785,733

 

 

 

6,530,142

 

Commitments and contingencies (see Note 9)

 

 

 

 

 

 

 

Shareholders’ equity/(deficit):

 

 

 

 

 

 

 

Series A convertible preferred stock, $0.0001 par value, 100,000,000 authorized;

   69,421,047 issued and outstanding at December 31, 2013; 5,000,000 shares

   authorized; no shares issued and outstanding at September 30, 2014; liquidation

   preference of $41,652,628 at December 31, 2013 (see Note 2).

 

6,942

 

 

 

Common stock, $0.0001 par value, 53,000,000 authorized; 185,550 issued and

   outstanding at December 31, 2013; 40,000,000 authorized; 4,449,603 issued and

   outstanding at September 30, 2014 (see Note 2).

 

19

 

 

 

445

 

Additional paid-in capital

 

109,958,001

 

 

 

137,749,933

 

Accumulated deficit

 

(122,420,976

)

 

 

(134,405,481

)

Total shareholders’ equity/(deficit)

 

(12,456,014

)

 

 

3,344,897

 

Total liabilities and shareholders’ equity/(deficit)

$

1,329,719

 

 

$

9,875,039

 

 

 

 

 

 

 

 

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,

 

 

2013

 

 

2014

 

 

2013

 

 

2014

 

Revenues

$

31,922

 

 

$

10,274

 

 

$

115,445

 

 

$

57,794

 

Cost of revenues

 

619,080

 

 

 

538,181

 

 

 

1,759,568

 

 

 

1,555,861

 

Gross loss

 

(587,158

)

 

 

(527,907

)

 

 

(1,644,123

)

 

 

(1,498,067

)

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

975,104

 

 

 

1,310,905

 

 

 

2,375,892

 

 

 

3,427,513

 

General and administrative expenses

 

806,872

 

 

 

1,060,812

 

 

 

1,736,192

 

 

 

3,970,579

 

Sales and marketing expenses

 

5,342

 

 

 

812,005

 

 

 

129,678

 

 

 

1,246,507

 

Loss from operations

 

(2,374,476

)

 

 

(3,711,629

)

 

 

(5,885,885

)

 

 

(10,142,666

)

Other income/(expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

(457,250

)

 

 

(151,491

)

 

 

(1,435,087

)

 

 

(1,640,045

)

Change in fair value of warrant liability

 

(7,647

)

 

 

3,326

 

 

 

593,365

 

 

 

(200,994

)

Other income/(expense)

 

(20,818

)

 

 

 

 

(32,767

)

 

 

Total other income/(expense)

 

(485,715

)

 

 

(148,165

)

 

 

(874,489

)

 

 

(1,841,039

)

Loss before income taxes

 

(2,860,191

)

 

 

(3,859,794

)

 

 

(6,760,374

)

 

 

(11,983,705

)

Income tax expense

 

 

 

 

 

 

 

(800

)

 

 

(800

)

Net loss & comprehensive loss

$

(2,860,191

)

 

$

(3,859,794

)

 

$

(6,761,174

)

 

$

(11,984,505

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

181,954

 

 

 

4,449,603

 

 

 

182,199

 

 

 

3,845,540

 

Diluted

 

181,954

 

 

 

4,449,603

 

 

 

182,199

 

 

 

3,845,540

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(15.72

)

 

$

(0.87

)

 

$

(37.11

)

 

$

(3.12

)

Diluted

$

(15.72

)

 

$

(0.87

)

 

$

(37.11

)

 

$

(3.12

)

 

 

 

 

 

 

 

 

 

 

 

 

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,

 

 

2013

 

 

2014

 

Cash Flows From Operating Activities

 

 

 

 

 

 

 

Net loss

$

(6,761,174

)

 

$

(11,984,505

)

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

 

 

 

 

 

 

 

Depreciation and amortization

 

202,641

 

 

 

177,516

 

Inventory reserve

 

68,496

 

 

 

(9,616

)

Stock-based compensation

 

683,396

 

 

 

1,506,586

 

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

 

1,302,136

 

 

 

1,428,324

 

Change in fair value of warrant liability

 

(593,365

)

 

 

200,994

 

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

 

 

 

 

 

 

 

Accounts receivable

 

(41,599

)

 

 

(3,245

)

Inventory

 

(97,342

)

 

 

(46,201

)

Prepaid expenses and other current assets

 

(25,255

)

 

 

(528,988

)

Other non-current assets

 

269,083

 

 

 

(28,894

)

Accounts payable

 

(120,781

)

 

 

(992,399

)

Accrued liabilities

 

271,470

 

 

 

(1,172,611

)

Non-current interest payable

 

 

 

33,905

 

Deferred rent

 

(34,749

)

 

 

33,238

 

Net cash used in operating activities

 

(4,877,043

)

 

 

(11,385,896

)

Cash Flows From Investing Activities

 

 

 

 

 

 

 

Purchases of fixed assets

 

(711

)

 

 

(201,835

)

Net cash used in investing activities

 

(711

)

 

 

(201,835

)

Cash Flows From Financing Activities

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

395

 

 

 

 

Payments for repurchase of shares

 

(4,111

)

 

 

 

Principal payments on equipment financing

 

 

 

(9,300

)

Net proceeds from issuance of common stock

 

 

 

17,390,240

 

Payments on supplier and other third party financings

 

(61,874

)

 

 

(163,411

)

Payments on line of credit

 

 

 

(2,346,000

)

Proceeds from borrowings on line of credit

 

1,490,996

 

 

 

365,000

 

Proceeds from issuance of convertible notes and warrants

 

3,570,000

 

 

 

175,000

 

Net proceeds from borrowings on credit facility and warrants

 

 

 

4,926,896

 

Net cash provided by financing activities

 

4,995,406

 

 

 

20,338,425

 

Net increase/(decrease) in Cash and Cash Equivalents

 

117,652

 

 

 

8,750,694

 

Cash and Cash Equivalents at Beginning of Period

 

185,256

 

 

 

69,178

 

Cash and Cash Equivalents at End of Period

$

302,908

 

 

$

8,819,872

 

Supplemental Disclosures of Cash Flow Information:

 

 

 

 

 

 

 

Cash paid during the period for:

 

 

 

 

 

 

 

         Interest

$

-

 

 

$

298,381

 

Taxes

$

800

 

 

$

800

 

 

 

 

 

 

 

 

6


Non-cash Investing and Financing Activities:

During the nine months ended September 30, 2013, 21,846 shares of common stock, with a par value of $0.0001, were issued for restricted stock units.

During the nine months ended September 30, 2013, convertible notes with a principal balance of $20,231,000 and accrued interest of approximately $2,581,000 were converted into 42,245,834 shares of preferred stock with a par value of $0.0001. In conjunction with this conversion, $236,799 of derivative warrant liabilities were reclassified to additional paid-in capital, as the underlying exercise prices on the warrants were determined by the debt conversion. Also during the nine months ended September 30, 2013, an additional $144,346 of derivative warrant liabilities were reclassified to additional paid-in capital when their underlying exercise price was fixed.

During the nine months ended September 30, 2013, the Company issued to its landlord a warrant to purchase common shares with a warrant coverage amount of $502,605 and an exercise price equal to the price per share of the Company’s common stock sold in the Company’s initial public offering (“IPO”) (see Note 2). The fair value of the warrant as calculated under the Company’s probability weighted Black-Scholes valuation model was approximately $309,000 at September 30, 2013, which was recorded on the condensed balance sheet as a component of deferred rent and warrant liability.

During the nine months ended September 30, 2014, the Company cancelled its private company directors and officers liability insurance 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 2013 Convertible Bridge Notes, and were recorded as a discount to outstanding debt at the date of issuance.

An 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 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 of the IPO 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 (see Note 4), which was not exercised and is recorded as an offset to additional paid-in capital within common stock issuance costs at September 30, 2014, (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 (see Note 4), and is recorded as an offset to additional paid-in capital within common stock issuance costs at September 30, 2014, (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 2008 Convertible Note 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 2013 Convertible Bridge Notes were converted at $10.00 per share into a total of 547,794 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 2013 Convertible Bridge Notes 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 2014 Credit Facility, and was recorded as a discount to outstanding debt at the date of issuance (see Note 6).

Fixed assets purchased totaling $4,775 during the nine months ended September 30, 2014 remain unpaid as of September 30, 2014, and are excluded from cash purchases in the Company’s unaudited condensed statement of cash flows.

A fixed asset purchased for $140,267 during the nine months ended September 30, 2014 is recorded as an equipment financing obligation and is excluded from cash purchases in the Company’s unaudited condensed statement 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 unaudited condensed balance sheet at December 31, 2013 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, 2013, filed with the SEC with our Annual Report on Form 10-K on March 28, 2014 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.

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) tests 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 CEE microfluidic channels, related equipment and certain reagents to perform the Company’s diagnostic tests 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 tests the Company offers are classified as laboratory developed tests (LDTs), 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 July 2013, the Financial Accounting Standards Board (“FASB”) issued authoritative guidance that requires netting unrecognized tax benefits against deferred tax assets for a loss or other carryforward that would apply in settlement of uncertain tax positions. This guidance is effective for annual reporting periods beginning after December 15, 2013, and was effective for the Company’s fiscal year beginning January 1, 2014. The adoption of this guidance did not have a material impact on the Company’s financial statements or disclosures.

In May 2014, 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 guidance is effective for annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period. Early adoption is not 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 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.

In August 2014, the FASB issued authoritative guidance 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

8


statements are issued. Certain additional 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.

 

2. Initial Public Offering

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, approximately $17,390,000 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 approximately $16,458,000 after deducting $932,136 of additional non-underwriter costs incurred that are 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 a grant date fair value of $202,143 (see Note 4), 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 a grant date fair value of $544,116 (see Note 4).

On February 4, 2014, as contemplated by the registration statement covering the IPO, 69,421,047 shares of outstanding Series A Preferred Stock 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.

In connection with the closing of the Company’s IPO on February 10, 2014, (i) the $1,400,000 principal amount and $233,982 of accrued interest related to the 2008 Convertible Note were converted at $10.00 per share into a total of 163,399 shares of common stock, (ii) the $5,165,000 principal amount and $313,017 of accrued interest related to the 2013 Convertible Bridge Notes 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 2013 Bridge Notes 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 $2,578,104 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, (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 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 $2,475,620 associated with the aggregate of 387,152 common stock warrants related to the Company’s 2013 Convertible Bridge Notes and Line of Credit were reclassified to additional paid-in capital when their underlying exercise price was fixed, (x) unamortized discounts of $996,024 related to the warrants associated with the 2013 Convertible Bridge Notes and Line of Credit were reclassified to interest expense, and (xi) offering costs associated with the IPO of $932,136 were reclassified from prepaid expenses and other current assets to additional paid-in capital, while additional 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.

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 $2,346,000 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 the payment of an aggregate $1,009,552 in deferred salary obligations, including contractual interest, to current and former named 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 named executive officers. Also on February 13, 2014, in connection with the closing of the IPO and pursuant to a Board resolution for a director compensation policy adopted in 2013, the Company’s Board of Directors approved annual cash retainers to non-employee directors, and granted 238,500 stock options under the 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 (see Note 7). 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 are 53,108 option awards granted to the Company’s non-executive Chairman, which vested fully on the date of grant (see Note 7).

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

9


as a result of the closing of the Company’s IPO on February 10, 2014 have been subsequently made in February and March 2014, using the net proceeds from the IPO.

During the nine months ended September 30, 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.

 

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.

At December 31, 2013 and September 30, 2014, the Company had accumulated deficits of approximately $122,421,000 and $134,405,000, respectively. For the three and nine months ended September 30, 2014, the Company incurred net losses of approximately $3,860,000 and $11,985,000, respectively. 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 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, 2014, cash and cash equivalents totaled approximately $8,820,000. On February 10, 2014, the Company received cash proceeds of approximately $17,390,000 as a result of the closing of its IPO, net of underwriting discounts and additional underwriting costs incurred (see Note 2). On April 30, 2014, the Company received net cash proceeds of approximately $4,927,000 pursuant to the execution of a term loan agreement with Oxford Finance LLC (see Note 6). Management expects that the Company will need additional financing in the future to execute on its current or future business strategies beyond the next six months. Until the Company can generate significant cash from operations, the Company expects to continue to fund its operations with the proceeds of offerings of the Company’s equity and debt securities. 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 addition to test revenues, such financing may be derived from one or more of the following types of transactions: debt, equity, product development, technology licensing or collaboration.

 

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 approximate their estimated fair values due to the short-term maturities of these financial instruments.

Warrant Liability Derivatives

The Company classified the fair value measurements of the Company’s warrant liability derivatives as Level 3 in all periods presented. The Company adjusted the carrying value of the warrants classified as liabilities until the completion of its IPO on February 10, 2014, at which time the exercise price was fixed at $10.00 per share and the fair value of the warrants was reclassified to shareholders’ deficit, except for a warrant for 1,587 preferred shares that remains outstanding at September 30, 2014 (see Note 2).

10


The aggregate fair value of the Company’s warrant liability at the closing of the IPO on February 10, 2014 was estimated using a Black-Scholes valuation model with the following assumptions for the five-year term and two-year term common stock warrants, respectively:

 

 

Five-year term

 

 

Two-year term

 

Stock price

$

8.91

 

 

$

8.91

 

Exercise price

$

10.00

 

 

$

10.00

 

Expected dividend yield

 

0.00

%

 

 

0.00

%

Discount rate-bond equivalent yield

 

1.48

%

 

 

0.32

%

Expected life (in years)

 

5.00

 

 

 

2.00

 

Expected volatility

 

90.0

%

 

 

90.0

%

 

The fair value attributed to such warrants as of December 31, 2013 and September 30, 2014 is as follows:

 

 

Fair Value Measurements Using

 

 

Quoted Prices

 

 

Significant

 

 

 

 

 

 

in Active

 

 

Other

 

 

Significant

 

 

Markets for

 

 

Observable

 

 

Unobservable

 

 

Identical Assets

 

 

Inputs

 

 

Inputs

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

Warrant Liability at December 31, 2013

 

 

 

 

 

 

 

2,140,532

 

Warrant Liability at September 30, 2014

 

 

 

 

 

 

 

1,128

 

 

The following table includes a summary of changes in the fair value of the warrants for the nine months ended September 30, 2014:

 

 

Fair Value Measurements

 

 

at Reporting Date Using

 

 

Significant Unobservable

 

 

Inputs (Level 3)

 

Balance at December 31, 2013

$

2,140,532

 

Warrant liability incurred

 

135,222

 

Change in fair value included in expense

 

200,994

 

Warrant liability reclassified to additional paid-in capital

 

(2,475,620

)

Balance at September 30, 2014

$

1,128

 

 

Other Fair Value Measurements

In connection with the closing of the Company’s IPO on February 10, 2014, the IPO’s underwriters were granted a 45 day option to purchase up to 285,000 shares of common stock to cover overallotments with a grant date fair value of $202,143, which was not exercised. Additionally, certain designees of the representative of the underwriters were issued warrants to buy (in the aggregate) up to 95,000 shares of common stock with a grant date fair value of $544,116. The fair values of these stock option and common stock warrants were estimated using probability weighted Black-Scholes valuation models with the following assumptions:

 

 

Options

 

 

Warrants

 

Stock price

$

8.91

 

 

$

8.91

 

Exercise price

$

9.30

 

 

$

12.50

 

Expected dividend yield

 

0.00

%

 

 

0.00

%

Discount rate-bond equivalent yield

 

0.07

%

 

 

1.46

%

Expected life (in years)

0.12

 

 

 

5.00

 

Expected volatility

 

70.0

%

 

 

90.0

%

 

The estimated grant date fair values of these non-cash equity classified instruments were recorded as an offset to additional paid-in capital within common stock issuance costs.

11


In connection with the closing of the Company’s Credit Facility on April 30, 2014, the lender was granted a warrant to purchase 52,966 shares of common stock with a 10 year term and an estimated grant date fair value of $233,107 (see Note 6). The fair value of this warrant was estimated using a Black-Scholes valuation model with the following assumptions:

 

Stock price

$

4.74

 

Exercise price

$

4.72

 

Expected dividend yield

 

0.00

%

Discount rate-bond equivalent yield

 

2.67

%

Expected life (in years)

 

10.00

 

Expected volatility

 

110.0

%

 

The estimated grant date fair value of this non-cash equity classified instrument was recorded as a discount to outstanding debt and is amortized to interest expense utilizing the effective interest method over the underlying term of the loan.

The estimated fair value of the Company’s Credit Facility at September 30, 2014 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 (see Note 6).

 

5. Balance Sheet Details

The following provides certain balance sheet details:

 

 

December 31,

 

 

September 30,

 

 

2013

 

 

2014

 

Fixed Assets

 

 

Machinery and equipment

$

2,761,560

 

 

$

2,773,875

 

Furniture and office equipment

 

209,844

 

 

 

209,844

 

Computer equipment and software

 

681,508

 

 

 

681,508

 

Leasehold improvements

 

373,653

 

 

 

506,328

 

Financed equipment

 

677,000

 

 

 

878,447

 

Construction in process

 

12,299

 

 

 

12,739

 

 

 

4,715,864

 

 

 

5,062,741

 

Less accumulated depreciation and amortization

 

4,356,977

 

 

 

4,534,493

 

Total fixed assets, net

$

358,887

 

 

$

528,248

 

Accrued Liabilities

 

 

 

 

 

 

 

Accrued interest

$

524,885

 

 

$

33,125

 

Accrued payroll

 

125,299

 

 

 

148,664

 

Deferred wages

 

1,377,987

 

 

 

 

Accrued vacation

 

213,601

 

 

 

251,108

 

Accrued bonuses

 

 

 

 

122,100

 

Other

 

286

 

 

 

25,605

 

Total accrued liabilities

$

2,242,058

 

 

$

580,602

 

 

As of December 31, 2013, the Company incurred $538,318 in costs directly associated with its IPO, which are reflected on the unaudited condensed balance sheet as a component of prepaid expenses and other current assets. As of September 30, 2014, a balance of $1,211,896 of such costs, in addition to underwriting discounts of $1,330,000 and an aggregate $746,259 of associated stock option and restricted stock awards, are offset against additional paid-in capital as a result of the closing of the Company’s IPO on February 10, 2014 (see Note 2).

 

6. Credit Facility

Effective as of April 30, 2014, the Company entered into a loan and security agreement (the “Credit Facility”) in an aggregate principal amount of up to $10.0 million with Oxford Finance LLC (“Oxford”) for working capital and general business purposes. The first term loan under the Credit Facility was funded on April 30, 2014 in a principal amount of $5.0 million. A second term loan of up to a principal amount of $5.0 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 $9.0 million for the trailing six month period by November 30, 2015. In connection with the first term loan under the Credit Facility, a facility fee of $50,000 was charged and an additional $50,000 facility fee will be due upon execution of the second term loan under the Credit Facility. The Credit Facility is secured by substantially all of the Company’s

12


assets other than its intellectual property. Each term loan under the 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%. The Company is required to make interest-only payments on the first term loan through February 1, 2016 if the funding date of the second term loan occurs before June 30, 2015, or through August 1, 2015 otherwise. If executed, interest-only payments are required to be made on the second term loan through February 1, 2016 if the funding date of the second term loan occurs before June 30, 2015, or through the seventh month following the funding date of the second term loan otherwise. The first term loan under the 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 required to make a final payment equal to 5.50% of the original principal amount(s) funded. At the Company’s option, the outstanding principal balance of the term loans may be repaid in whole but not in part, subject to a prepayment fee of 3% of any amount prepaid if the prepayment occurs on or prior to April 30, 2015, 2% of the amount prepaid if the prepayment occurs after April 30, 2015 but on or prior to April 30, 2016, and 1% of any amount prepaid after April 30, 2016. Additionally, 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 on April 30, 2014 (see Note 4). Additional warrants for shares of the Company’s common stock will be issued upon execution of the second term loan under the 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.

Issuance costs of $73,104 associated with the first term loan under the Credit Facility were deducted from the gross proceeds by the lender and were recorded as a discount to outstanding debt as of the closing date, resulting in net proceeds of $4,926,896. Other issuance costs of $28,932 directly related to the Credit Facility but not associated with the lender were recorded as a component of other non-current assets in the unaudited condensed balance sheet. The estimated fair value of the warrant issued of $233,107 was recorded as a discount to outstanding debt as of the closing date. The discounts and other issuance costs are amortized to interest expense utilizing the effective interest method over the underlying term of the loan. The total amount of interest expense recorded during the three and nine months ended September 30, 2014 related to the Credit Facility was $144,717 and $240,850, respectively. The Credit Facility bears an effective annual interest rate of 10.81% at both April 30, 2014 and September 30, 2014.

 

7. Stock-based Compensation

Stock Options

A summary of stock option activity for option awards granted under the Company’s 2007 Equity Incentive Plan and 2013 Equity Incentive Plan for the nine months ended September 30, 2014 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, 2013

 

331,540

 

 

$

5.14

 

 

9.3

 

Outstanding at December 31, 2013

 

333,106

 

 

$

5.14

 

 

9.3

 

Granted

 

594,798

 

 

$

7.06

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

Cancelled/forfeited/expired

 

(52,862

)

 

$

4.66

 

 

 

 

 

Outstanding at September 30, 2014

 

875,042

 

 

$

6.47

 

 

 

9.2

 

Vested and unvested expected to vest, September 30, 2014

 

871,124

 

 

$

6.48

 

 

 

9.2

 

The intrinsic values of options outstanding and options vested and unvested expected to vest at September 30, 2014 were zero.

The fair values of option awards granted during the nine months ended September 30, 2014 were estimated using a Black-Scholes pricing model with the following assumptions:

 

Stock and exercise prices

$4.38 - $9.11

 

Expected dividend yield

 

0.00

%

Discount rate-bond equivalent yield

1.56% – 2.06%

 

Expected life (in years)

5.00 – 6.08

 

Expected volatility

90.0% – 100.0%

 

Expected forfeiture rate

0.00% – 5.00%

 

13


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, 2014 was $5.51 per share.

Further information about the options outstanding and exercisable at September 30, 2014 is as follows:

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

Weighted

 

 

 

 

 

 

Average

 

 

 

 

 

Average

 

 

Total Shares

 

 

Contractual

 

 

Total Shares

 

Exercise Price

 

 

Outstanding

 

 

Life (in years)

 

 

Exercisable

 

$

4.38

 

 

 

86,458

 

 

 

9.6

 

 

 

8,540

 

$

4.62

 

 

 

19,928

 

 

 

6.5

 

 

 

17,473

 

$

5.03

 

 

 

21,500

 

 

 

9.8

 

 

 

$

5.04

 

 

 

8,233

 

 

 

4.8

 

 

 

8,233

 

$

5.18

 

 

 

285,625

 

 

 

8.8

 

 

 

159,406

 

$

5.35

 

 

 

117,500

 

 

 

9.7

 

 

 

4,686

 

$

7.50

 

 

 

43,000

 

 

 

9.5

 

 

 

$

8.88

 

 

 

238,500

 

 

 

9.4

 

 

 

$

9.11

 

 

 

54,298

 

 

 

9.4

 

 

 

54,298

 

 

 

 

 

 

875,042

 

 

 

 

 

 

 

252,636

 

The intrinsic value of options exercisable at September 30, 2014 was zero.

Performance Stock Units

On June 12, 2014, the Company’s Board of Directors approved the issuance of 44,496 Restricted Stock Units (“RSUs”) to its Chief Executive Officer pursuant to its 2013 Equity Incentive Plan. Vesting of the RSU’s may occur based on the Company’s achievement of specified objectives as determined by the Company’s Board of Directors or Compensation Committee, as follows:

 

 

Percentage of

 

 

Overall RSU

 

 

Grant Subject to

 

 

Vesting

 

Target

 

 

 

Minimum revenue in 2015

 

25

%

Maximum EBITDA loss in 2015

 

15

%

Attainment of financial plan for fiscal 2015

 

20

%

Minimum value of strategic agreements by December 31, 2015

 

20

%

Implementation of four new diagnostic test panels by

     December 31, 2015

 

20

%

Total

 

100

%

The amount of compensation expense recognized is based on management’s estimate of the most likely outcome.

14


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,

 

 

2013

 

 

2014

 

 

2013

 

 

2014

 

Stock Options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

$

246,313

 

 

$

35,569

 

 

$

253,828

 

 

$

149,626

 

General and administrative expenses

 

141,693

 

 

 

236,769

 

 

 

155,197

 

 

 

908,490

 

Sales and marketing expenses

 

 

 

27,834

 

 

 

 

 

46,762

 

Total expenses related to stock options

 

388,006

 

 

 

300,172

 

 

 

409,025

 

 

 

1,104,878

 

RSUs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

 

7,500

 

 

 

 

 

22,500

 

General and administrative expenses

 

 

 

13,750

 

 

 

274,371

 

 

 

379,208

 

Total stock-based compensation

$

388,006

 

 

$

321,422

 

 

$

683,396

 

 

$

1,506,586

 

As of September 30, 2014, total unrecognized stock-based compensation expense related to unvested stock option and RSU awards, adjusted for estimated forfeitures, was approximately $2,916,000 and $71,000, respectively, and is expected to be recognized over a weighted-average period of 2.7 years and 0.8 years, respectively.

 

8. 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, 2013 and 2014, the outstanding shares of Series A preferred stock, RSUs, convertible debt, 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.

In November 2013, the Company effected a 1:14 reverse stock split of all common shares outstanding. The calculation of weighted-average shares outstanding has been adjusted for this reverse split as if it had occurred on January 1, 2013.

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,

 

 

2013

 

 

2014

 

Series A preferred (number of common stock equivalents)

 

1,652,851

 

 

 

Preferred warrants outstanding (number of common stock

     equivalents)

 

192,262

 

 

 

1,587

 

Notes payable convertible into preferred shares (number

     of common stock equivalents)

 

232,558

 

 

 

Preferred share RSUs (number of common stock equivalents)

 

68,546

 

 

 

73,151

 

Common warrants outstanding

 

630,110

 

 

 

609,187

 

Notes payable convertible into common shares

 

741,857

 

 

 

Common share RSUs

 

133,971

 

 

 

178,467

 

Common options outstanding

 

344,565

 

 

 

875,042

 

Total anti-dilutive common share equivalents

 

3,996,720

 

 

 

1,737,434

 

 

 

 

 

 

9. 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 which are expected to have a material adverse effect on its financial condition, results of operations or liquidity.

15


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


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

An investment in our common stock involves a high degree of risk. You should consider carefully the risks described below, together with all of the other information included in this Quarterly Report, as well as in our other filings with the SEC, in evaluating our business. If any of the following risks actually occur, our business, financial condition, operating results and future prospects could be materially and adversely affected. In that case, the trading price of our common stock may decline and you might lose all or part of your investment. The risks described below are not the only ones we face. Additional risks that we currently do not know about or that we currently believe to be immaterial may also impair our business, financial condition, operating results and prospects. Certain statements below are forward-looking statements. For additional information, see the information included under the heading “Important Note Regarding Forward-Looking Statements.”

We are an early-stage cancer diagnostics company that develops and commercializes proprietary circulating tumor cell, or CTC, and circulating tumor DNA, or ctDNA, tests utilizing a standard blood sample. Our current CTC breast cancer test provides, and our planned future tests would provide, information to oncologists 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 cancer test and our planned future tests utilize our Cell Enrichment and Extraction (CEE) technology for the enumeration and analysis of CTCs, and our CEE-Selector technology for the detection and analysis of ctDNA, each performed on a standard blood sample. The CEE technology is an internally developed, 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 CEE-Selector technology enables mutation detection with enhanced sensitivity and specificity and is applicable to nucleic acid from CTCs or other samples types, such as blood plasma for ctDNA. We believe the CEE-Selector technology is an important part of certain of our pipeline CTC tests and will be a stand-alone test for molecular analysis of biomarkers.

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, or CLIA, and accredited by the College of American Pathologists, or CAP. We manufacture our CEE microfluidic channels, related equipment and certain reagents to perform our current breast cancer test and our planned future tests 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 tests we offer and intend to offer are classified as laboratory developed tests, or LDTs, under CLIA regulations.

We are in the process of commercializing our first test, OncoCEE-BR, for breast cancer, and launched our OncoCEE-LU test for non-small cell lung cancer, or NSCLC, in November of 2014. These tests 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 test, biomarker analysis involves fluorescence in situ hybridization, or FISH, for the detection and quantitation of the human epidermal growth factor receptor 2, or HER2, gene copy number as well as immunocytochemical analysis of estrogen receptor protein, which is now launched. We plan to include immunocytochemical analysis of progesterone receptor proteins in the OncoCEE-BR test within the next year. A patient’s HER2 status provides the physician with information about the appropriateness of therapies such as Herceptin ® or Tykerb ® . Estrogen receptor (ER) 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 test’s biomarker analysis currently includes FISH testing for ALK gene fusions. We plan to add FISH testing for ROS1 as well as mutation analysis for the epidermal growth factor receptor, or EGFR, gene, the K-ras gene and the B-raf gene in the future. 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 T790M mutation of the EGFR gene as a resistance marker for EGFR tyrosine kinase inhibitors is linked to drugs in clinical development that address this resistance. 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 ® , and the codon 600 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. Our OncoCEE-LU test is performed on a standard blood sample.

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We plan to add other biomarker analyses on blood samples to our current breast cancer test and our planned future OncoCEE tests as their relevance is demonstrated in clinical trials, for example, ret proto-oncogene gene fusions in NSCLC, which may indicate a particular course of therapy, and NRAS for melanoma, which may predict therapy resistance. In addition, we are developing a series of other CTC and ctDNA tests for different solid tumor types, including colorectal cancer, prostate cancer, gastric cancer and melanoma, each incorporating treatment-associated biomarker analyses specific to that cancer, planned to be launched as noted in the table below.

 

Test Name/ Solid Tumor Type

 

Biomarkers

 

Indication

 

Status of Test or
Project

 

Targeted Quarter
of Availability for
Commercialization

OncoCEE-BR TM / Breast Cancer

 

Enumeration, HER2 by FISH, ER

 

Prognosis, therapy selection, monitoring

 

Currently available

 

N/A

 

 

 

 

 

 

 

PR

 

Prognosis, therapy selection, monitoring

 

Validation

 

2015 Q2

 

 

 

 

 

 

 

ER Mutation by CEE- Selector TM

 

Prognosis, therapy selection, monitoring

 

Development

 

2015 Q2

 

 

 

 

 

OncoCEE-LU TM / Lung Cancer

 

Enumeration, ALK by FISH

 

Prognosis, therapy selection, monitoring

 

Currently available

 

N/A

 

 

 

 

 

 

 

Met and ROS1 by FISH

 

Prognosis, therapy selection, monitoring

 

Validation

 

2014 Q4, 2015 Q1

 

 

 

 

 

 

 

 

 

 

 

K-ras, B-raf , EGFR and ALK mutations by CEE-Selector TM

 

Prognosis, therapy selection, monitoring

 

Development and Validation

 

2014 Q4, 2015 Q1, Q2

 

 

 

 

 

OncoCEE-GA TM / Gastric Cancer

 

Enumeration, HER2 by FISH

 

Prognosis, therapy selection, monitoring

 

Validation

 

2014 Q4

 

 

 

 

 

OncoCEE-CR TM / Colorectal Cancer

 

Enumeration, EGFR by FISH

 

Prognosis, therapy selection, monitoring

 

Validation

 

2015 Q2

 

 

 

 

 

 

 

K-ras and B-raf by CEE-Selector TM

 

Prognosis, therapy selection, monitoring

 

Development

 

2015 Q2

 

 

 

 

 

OncoCEE-PR TM / Prostate Cancer

 

Enumeration, PTEN deletion and AR by FISH

 

Prognosis, therapy selection, monitoring

 

Validation

 

2015 Q3

 

 

 

 

 

OncoCEE-ME TM / Melanoma

 

Enumeration, B-raf and N-ras mutations by CEE-Selector TM

 

Prognosis, therapy selection, monitoring

 

Development

 

2015 Q2

 

 

 

 

 

OncoCEE-DTC TM

 

Breast and Prostate Cancer- DTC analysis in bone marrow; HER2 and AR/PTEN by FISH, respectively

 

Prognosis, therapy selection, monitoring

 

Currently available for Research and Pharma

 

 

 

 

 

 

 

CEE-Selector TM

 

Sequencing application for multiple cancer types- K-ras, B-raf, EGFR and other mutations detected in plasma.

 

Therapy selection, monitoring

 

Development

 

2015 Q3

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.

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We accessioned 96 commercial cases during the three months ended September 30, 2014 as compared to 10 commercial cases for the same period in 2013, an increase of 86 cases, or 860%. We accessioned 110 commercial cases during the nine months ended September 30, 2014 as compared to 42 cases for the same period in 2013, an increase of 68 cases, or 162%. Revenues from commercial cases are recognized as collected. The expected collection period for the commercial cases accessioned during the three months ended September 30, 2014 extends beyond the end of the reporting period.

Results of Operations

Three Months Ended September 30, 2013 and 2014

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

 

 

Three Months Ended September 30,

 

 

Change

 

 

2013

 

 

2014

 

 

$

 

 

%

 

(dollars in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

$

32

 

 

$

10

 

 

$

(22

)

 

 

(69

%)

Cost of revenues

 

619

 

 

 

538

 

 

 

(81

)

 

 

(13

%)

Research and development expenses

 

975

 

 

 

1,311

 

 

 

336

 

 

 

34

%

General and administrative expenses

 

807

 

 

 

1,061

 

 

 

254

 

 

 

31

%

Sales and marketing expenses

 

5

 

 

 

812

 

 

 

807

 

 

 

16,140

%

Loss from operations

 

(2,374

)

 

 

(3,712

)

 

 

(1,338

)

 

 

56

%

Interest expense, net

 

(457

)

 

 

(151

)

 

 

306

 

 

 

(67