0001104659-14-038337.txt : 20140514 0001104659-14-038337.hdr.sgml : 20140514 20140514073043 ACCESSION NUMBER: 0001104659-14-038337 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 10 CONFORMED PERIOD OF REPORT: 20140331 FILED AS OF DATE: 20140514 DATE AS OF CHANGE: 20140514 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NephroGenex, Inc. CENTRAL INDEX KEY: 0001338095 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-36303 FILM NUMBER: 14839200 BUSINESS ADDRESS: STREET 1: 79 T.W. ALEXANDER DRIVE STREET 2: 4401 RESEARCH COMMONS BLDG., SUITE 290 CITY: RESEARCH TRIANGLE PARK STATE: NC ZIP: 27709 BUSINESS PHONE: (609) 986-1780 MAIL ADDRESS: STREET 1: 79 T.W. ALEXANDER DRIVE STREET 2: 4401 RESEARCH COMMONS BLDG., SUITE 290 CITY: RESEARCH TRIANGLE PARK STATE: NC ZIP: 27709 FORMER COMPANY: FORMER CONFORMED NAME: NephroGenex Inc DATE OF NAME CHANGE: 20050907 10-Q 1 a14-11323_110q.htm 10-Q

Table of Contents

 

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2014

 

OR

 

o         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 001-36303

 


 

NEPHROGENEX, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

20-1295171

(State or other jurisdiction of

 

(I.R.S. Employer Identification No.)

incorporation or organization)

 

 

 

 

 

79. T.W. Alexander Drive

 

 

4401 Research Commons Building

 

 

Suite 290 P.O. Box 14188

 

 

Research Triangle Park

 

27709

(Address of principal executive offices)

 

(Zip Code)

 

(609) 986-1780

(Registrant’s telephone number, including area code)

 

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 o

 

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 o

 

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 o

 

Accelerated filer o

 

 

 

Non-accelerated filer o

 

Smaller reporting company x

(Do not check if a smaller reporting company)

 

 

 

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

 

The number of shares outstanding of the registrant’s common stock as of May 8, 2014 was 8,555,114.

 

 

 



Table of Contents

 

NephroGenex, Inc.

(A Development Stage Company)

 

Form 10-Q

For the Three Months Ended March 31, 2014

 

TABLE OF CONTENTS

 

PART I — FINANCIAL INFORMATION

 

 

 

 

Item 1.

Financial Statements:

 

 

 

 

 

Balance Sheets as of March 31, 2014 (unaudited) and December 31, 2013

2

 

 

 

 

Statements of Comprehensive Loss (unaudited) for the three months ended March 31, 2014 and 2013 and the period from May 25, 2004 (inception) to March 31, 2014

3

 

 

 

 

Statement of Stockholders’ Equity (Deficiency)

4

 

 

 

 

Statements of Cash Flows (unaudited) for the three months ended March 31, 2014 and 2013 and from the period from May 25, 2004 (inception) to March 31, 2014

5

 

 

 

 

Notes to Unaudited Financial Statements

6

 

 

 

Item 2.

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

17

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

24

 

 

 

Item 4.

Controls and Procedures

24

 

 

 

PART II — OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

24

 

 

 

Item 1A.

Risk Factors

24

 

 

 

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

 

 

 

Signatures

26

 

1



Table of Contents

 

PART I — FINANCIAL INFORMATION

 

Item 1.  Financial Statements

 

NephroGenex, Inc.

(A Development Stage Company)

 

Balance Sheets

 

 

 

March 31,

 

December 31,

 

 

 

2014

 

2013

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

33,513,394

 

$

2,131,990

 

Prepaid expenses and other assets

 

667,782

 

11,711

 

Total current assets

 

34,181,176

 

2,143,701

 

 

 

 

 

 

 

Property and equipment, net

 

13,989

 

10,826

 

Deferred initial public offering costs

 

 

461,079

 

Other assets

 

4,097

 

4,097

 

Total assets

 

$

34,199,262

 

$

2,619,703

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity (Deficiency)

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

 

$

76,169

 

$

47,865

 

Accrued and other liabilities

 

707,587

 

1,858,061

 

Preferred stock warrant liability

 

 

6,982,640

 

Convertible notes payable

 

 

7,916,870

 

Total current liabilities

 

783,756

 

16,805,436

 

 

 

 

 

 

 

Stockholders’ equity (deficiency)

 

 

 

 

 

Series A preferred stock: $.001 par value; 32,690,676 shares authorized; 0 and 23,688,396 shares issued and outstanding as of March 31, 2014 and December 31, 2013, respectively

 

 

23,688

 

Preferred stock; $.001 par value; 5,000,000 shares authorized; no shares issued and outstanding

 

 

 

Common stock; $.001 par value; 100,000,000 shares authorized; 8,855,114 and 319,882 shares issued and outstanding as of March 31, 2014 and December 31, 2013, respectively

 

8,855

 

320

 

Additional paid-in capital

 

76,106,173

 

26,789,465

 

Deficit accumulated during the development stage

 

(42,699,522

)

(40,999,206

)

Total stockholders’ equity (deficiency)

 

33,415,506

 

(14,185,733

)

Total liabilities and stockholders’ equity (deficiency)

 

$

34,199,262

 

$

2,619,703

 

 

See Notes to Financial Statements

 

2



Table of Contents

 

NephroGenex, Inc.

(A Development Stage Company)

 

Statements of Comprehensive Loss

 

 

 

 

 

 

 

Cumulative

 

 

 

Three

 

Three

 

Period From

 

 

 

Months Ended

 

Months Ended

 

May 25, 2004

 

 

 

March 31,

 

March 31,

 

(inception) to

 

 

 

2014

 

2013

 

March 31, 2014

 

 

 

(unaudited)

 

(unaudited)

 

(unaudited)

 

Expenses:

 

 

 

 

 

 

 

Research and development

 

$

457,376

 

$

264,560

 

$

29,465,241

 

General and administrative

 

1,034,425

 

138,137

 

5,485,469

 

Total expenses

 

1,491,801

 

402,697

 

34,950,710

 

 

 

 

 

 

 

 

 

Loss from operations

 

(1,491,801

)

(402,697

)

(34,950,710

)

Other income (expense):

 

 

 

 

 

 

 

Change in value of preferred stock warrants

 

(140,428

)

 

(7,178,162

)

Interest expense

 

(78,084

)

(71,303

)

(1,510,849

)

Interest income

 

9,997

 

176

 

695,720

 

Qualifying Therapeutic Discovery Program grant

 

 

 

244,479

 

Net loss

 

$

(1,700,316

)

$

(473,824

)

$

(42,699,522

)

 

 

 

 

 

 

 

 

Net loss per share – basic and diluted

 

$

(0.37

)

$

(1.48

)

$

(140.53

)

 

 

 

 

 

 

 

 

Weighted average shares outstanding – basic and diluted

 

4,587,498

 

319,882

 

303,856

 

Comprehensive loss

 

$

(1,700,316

)

$

(473,824

)

$

(42,699,522

)

 

See Notes to Financial Statements

 

3



Table of Contents

 

NephroGenex, Inc.

(A Developmental Stage Company)

 

Statement of Stockholders’ Equity (Deficiency)

 

 

 

Series A Convertible

 

 

 

Additional

 

Accumulated

 

 

 

 

 

Preferred Stock

 

Common Stock

 

Paid-In

 

During the

 

 

 

 

 

Shares

 

Amount

 

Shares

 

Amount

 

Capital

 

Development Stage

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at May 25, 2004 (inception)

 

 

$

 

 

$

 

$

 

$

 

$

 

Sale of common stock for cash in May 2004 at $0.05 per share

 

 

 

1,690

 

2

 

548

 

 

550

 

Net loss

 

 

 

 

 

 

(129,923

)

(129,923

)

Balance at December 31, 2004

 

 

 

1,690

 

2

 

548

 

(129,923

)

(129,373

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

(688,915

)

(688,915

)

Balance at December 31, 2005

 

 

 

1,690

 

2

 

548

 

(818,838

)

(818,288

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares to BioStratum, Inc. (Note G)

 

 

 

12,707

 

13

 

4,948

 

 

4,961

 

Issuance of shares and warrant to Vanderbilt University (Note G)

 

 

 

461

 

 

6,910

 

 

6,910

 

Issuance of shares to Tryggvason Biotech AB (Note G)

 

 

 

151

 

 

60

 

 

60

 

Net loss

 

 

 

 

 

 

(1,337,715

)

(1,337,715

)

Balance at December 31, 2006

 

 

 

15,009

 

15

 

12,466

 

(2,156,553

)

(2,144,072

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of Series A preferred stock for cash, licensed technology and the conversion of debt in May 2007 (Note E)

 

4,783,612

 

4,784

 

 

 

2,498,539

 

 

2,503,323

 

Issuance of shares to FibroStatin, SL (Note G)

 

 

 

153

 

 

5,000

 

 

5,000

 

Exercise of warrant by Vanderbilt University (Note G)

 

 

 

17,257

 

17

 

(17

)

 

 

Sale of Series A preferred stock for cash in December 2007

 

1,800,456

 

1,800

 

 

 

2,243,602

 

 

2,245,402

 

Net loss

 

 

 

 

 

 

(7,570,642

)

(7,570,642

)

Balance at December 31, 2007

 

6,584,068

 

6,584

 

32,419

 

32

 

4,759,590

 

(9,727,195

)

(4,960,989

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of Series A preferred stock and common stock in March 2008 (Note E)

 

16,204,100

 

16,204

 

45,230

 

45

 

20,214,872

 

 

20,231,121

 

Issuance of common stock to BioStratum, Inc. (Note G)

 

 

 

207,744

 

208

 

80,813

 

 

81,021

 

Issuance of common stock to Vanderbilt University (Note G)

 

 

 

24,013

 

24

 

9,341

 

 

9,365

 

Stock based compensation

 

 

 

 

 

115,347

 

 

115,347

 

Net loss

 

 

 

 

 

 

(6,740,834

)

(6,740,834

)

Balance at December 31, 2008

 

22,788,168

 

22,788

 

309,406

 

309

 

25,179,963

 

(16,468,029

)

8,735,031

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock based compensation

 

 

 

 

 

126,725

 

 

126,725

 

Net loss

 

 

 

 

 

 

(7,549,788

)

(7,549,788

)

Balance at December 31, 2009

 

22,788,168

 

22,788

 

309,406

 

309

 

25,306,688

 

(24,017,817

)

1,311,968

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon exercise of stock options

 

 

 

10,476

 

11

 

5,575

 

 

 

5,586

 

Sale of Series A preferred stock in July 2010

 

900,228

 

900

 

 

 

999,100

 

 

1,000,000

 

Stock based compensation

 

 

 

 

 

139,209

 

 

139,209

 

Net loss

 

 

 

 

 

 

(5,920,765

)

(5,920,765

)

Balance at December 31, 2010

 

23,688,396

 

23,688

 

319,882

 

320

 

26,450,572

 

(29,938,582

)

(3,464,002

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock based compensation

 

 

 

 

 

125,370

 

 

125,370

 

Net loss

 

 

 

 

 

 

(1,851,797

)

(1,851,797

)

Balance at December 31, 2011

 

23,688,396

 

23,688

 

319,882

 

320

 

26,575,942

 

(31,790,379

)

(5,190,429

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock based compensation

 

 

 

 

 

125,506

 

 

125,506

 

Net loss

 

 

 

 

 

 

(2,904,164

)

(2,904,164

)

Balance at December 31, 2012

 

23,688,396

 

23,688

 

319,882

 

320

 

26,701,448

 

(34,694,543

)

(7,969,087

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock based compensation

 

 

 

 

 

88,017

 

 

88,017

 

Net loss

 

 

 

 

 

 

(6,304,663

)

(6,304,663

)

Balance at December 31, 2013

 

23,688,396

 

23,688

 

319,882

 

320

 

26,789,465

 

(40,999,206

)

(14,185,733

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at IPO, net of expenses of $3,767,348 (unaudited)

 

 

 

3,100,000

 

3,100

 

33,429,552

 

 

33,432,652

 

Issuance of common stock for preferred stock warrant (unaudited)

 

 

 

593,589

 

594

 

7,122,474

 

 

7,123,068

 

Issuance of common stock for convertible notes and accrued interest (unaudited)

 

 

 

1,197,289

 

1,197

 

8,643,852

 

 

8,645,049

 

Issuance of common stock for preferred stock (unaudited)

 

(23,688,396

)

(23,688

)

3,644,354

 

3,644

 

20,044

 

 

 

Stock based compensation (unaudited)

 

 

 

 

 

100,786

 

 

100,786

 

Net loss (unaudited)

 

 

 

 

 

 

(1,700,316

)

(1,700,316

)

Balance at March 31, 2014 (unaudited)

 

 

 

8,855,114

 

$

8,855

 

$

76,106,173

 

$

(42,699,522

)

$

33,415,506

 

 

See Notes to Financial Statements

 

4



Table of Contents

 

NephroGenex, Inc.

(A Developmental Stage Company)

 

Statements of Cash Flows

 

 

 

Three

 

Three

 

Cumulative Period

 

 

 

Months Ended

 

Months Ended

 

from May 25, 2004

 

 

 

March 31,

 

March 31,

 

(Inception) to

 

 

 

2014

 

2013

 

March 31, 2014

 

 

 

(unaudited)

 

(unaudited)

 

(unaudited)

 

Operating activities

 

 

 

 

 

 

 

Net loss

 

$

(1,700,316

)

$

(473,824

)

$

(42,699,522

)

Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities

 

 

 

 

 

 

 

Depreciation and amortization

 

753

 

3,143

 

106,932

 

Common stock issued in consideration for research and development

 

 

 

1,218,297

 

Change in fair value of preferred stock warrants

 

140,428

 

 

7,178,162

 

Non-cash interest expense

 

78,084

 

 

1,486,952

 

Stock based compensation expense

 

100,786

 

23,940

 

820,960

 

Changes in operating assets and liabilities

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

(656,071

)

6,442

 

(671,879

)

Accounts payable, accrued and other liabilities

 

(46,581

)

(50,499

)

777,799

 

Net cash and cash equivalents used in operating activities

 

(2,082,917

)

(490,798

)

(31,782,299

)

 

 

 

 

 

 

 

 

Investing activities

 

 

 

 

 

 

 

Property and equipment purchases

 

(3,916

)

 

(120,921

)

Net cash and cash equivalents used in investing activities

 

(3,916

)

 

(120,921

)

 

 

 

 

 

 

 

 

Financing activities

 

 

 

 

 

 

 

Proceeds from issuance of notes payable

 

 

 

1,655,000

 

Payment of note payable

 

 

 

(100,000

)

Proceeds from issuance of convertible notes payable

 

 

512,048

 

7,916,870

 

Payment of initial public offering costs

 

(3,731,763

)

 

(3,761,392

)

Proceeds from issuance of common stock, Series A preferred stock and warrants

 

37,200,000

 

 

59,700,550

 

Proceeds from exercise of common stock options

 

 

 

5,586

 

Net cash and cash equivalents provided by financing activities

 

33,468,237

 

512,048

 

65,416,614

 

Net increase in cash and cash equivalents

 

31,381,404

 

21,250

 

33,513,394

 

Cash and cash equivalents at beginning of period

 

2,131,990

 

323,678

 

 

Cash and cash equivalents at end of period

 

$

33,513,394

 

$

344,928

 

$

33,513,394

 

 

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information

 

 

 

 

 

 

 

Cash paid for interest

 

$

 

$

 

$

4,690

 

 

 

 

 

 

 

 

 

Supplemental disclosure of noncash financing activities

 

 

 

 

 

 

 

Conversion of notes payable into Series A preferred stock and warrants

 

$

 

$

 

$

1,555,000

 

Conversion of accrued interest into Series A preferred stock and warrants

 

$

 

$

 

$

758,772

 

Increase in paid-in capital resulting from exercise of warrant

 

$

 

$

 

$

2,458,882

 

Initial public offering costs included in accrued and other liabilities

 

$

5,956

 

$

 

$

5,956

 

Conversion of convertible notes payable, accrued interest, preferred stock and warrants into common stock

 

$

15,791,805

 

$

 

$

15,791,805

 

 

See Notes to Financial Statements

 

5



Table of Contents

 

NephroGenex, Inc.

(A Development Stage Company)

 

Notes to Financial Statements

 

March 31, 2014 and 2013 and the period from May 25, 2004 (inception) to March 31, 2014

 

NOTE A—ORGANIZATION, HISTORY AND NATURE OF OPERATIONS

 

NephroGenex, Inc. (the “Company”) was incorporated in Delaware on May 25, 2004. The Company is a drug development company focused on developing novel therapies for kidney disease. The Company acquired commercial rights to Pyridorin™ and has completed a Phase 2b clinical study in diabetic nephropathy patients.

 

The Company’s primary efforts to date have been devoted to raising capital, recruiting senior management and staff and conducting research and development activities. Accordingly, the Company is considered to be in the development stage. The Company has had limited capital resources and has experienced recurring net losses and negative cash flows from operations since inception. Operations have been financed to date by debt and equity financings as discussed in Notes D and E. On February 14, 2014, the Company closed its initial public offering of 3,100,000 shares of common stock at a price of $12.00 per share for total gross proceeds of $37.2 million, less underwriting discounts, commissions and offering expenses.

 

In addition to the normal risks associated with a new business venture, the Company currently has no commercially approved products and there can be no assurance that the Company’s research and development will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property.

 

NOTE B—SIGNIFICANT ACCOUNTING POLICIES

 

[1]                                 Basis of presentation:

 

The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).

 

From its inception, the Company has devoted substantially all of its efforts to business planning, engaging regulatory, manufacturing and other technical consultants, acquiring operating assets, planning clinical trials and raising capital. The Company has experienced net losses since its inception and, as of March 31, 2014, had a deficit accumulated during the development stage of $42.7 million.

 

[2]                                 Use of estimates:

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

[3]                                 Segment reporting:

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment.

 

[4]                                 Cash and cash equivalents:

 

The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents.

 

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[5]                                 Property and equipment:

 

Property and equipment consists of furniture, fixtures and computers. Property and equipment are carried at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the respective asset’s useful life. Maintenance and repairs that do not improve or extend the life of assets are expensed as incurred. When an asset is retired or disposed of, the cost and related accumulated depreciation are removed from the accounts and any resulting gains or losses are reflected within the statement of operations.

 

[6]                                 Fair value of financial instruments:

 

FASB ASC 820—Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. The estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments.

 

FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).

 

The three levels of the fair value hierarchy are as follows:

 

·                  Level 1—Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities.

 

·                  Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g. quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.

 

·                  Level 3—Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.

 

The carrying amounts reported in the balance sheet for cash and cash equivalents, accounts payable and accrued expenses approximate their fair value based on the short-term maturity of these instruments. The carrying amounts reported in the balance sheet for notes payable approximate their fair value based on market rates of interest and the terms of the notes. The Company recognizes all derivative financial instruments as assets or liabilities in the financial statements and measures them at fair value with changes in fair value reflected as current period income or loss unless the derivatives qualify as hedges. Certain terms of the May 4, 2007 Stock Purchase Agreement were accounted for as derivatives, which were valued under Level 3 of the fair value hierarchy. See Note E, Stockholders’ Equity (Deficit).

 

[7]                           Research and development costs:

 

Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities including non-cash share-based compensation, costs for third-party contractors to perform research, conduct clinical trials and prepare drug materials, research supplies and facilities costs. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered.

 

[8]                            Income taxes:

 

The Company utilizes the liability method of accounting for income taxes as required by FASB ASC Topic 740 Income Taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected

 

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to be in effect when the differences are expected to reverse. Uncertain tax positions are evaluated in accordance with this topic and if appropriate, the amount of unrecognized tax benefits are recorded within deferred tax assets. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.

 

ASC Topic 740 also clarifies the accounting for uncertainty in income taxes recognized in the financial statements. The interpretation prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. There were no significant matters determined to be unrecognized tax benefits taken or expected to be taken in a tax return that have been recorded in the Company’s financial statements through March 31, 2014. ASC Topic 740 provides guidance on the recognition of interest and penalties related to income taxes. There were no interest or penalties related to income taxes that have been accrued or recognized as of March 31, 2014 or for the three months ended March 31, 2014 or 2013, or for the period from May 25, 2004 (inception) to March 31, 2014. The Company has elected to treat interest and penalties, to the extent they arise, as a component of income taxes. Tax years beginning in 2010 for federal purposes are generally subject to examination by taxing authorities, although net operating losses from all prior years are subject to examinations and adjustments for at least three years following the year in which the tax attributes are utilized.

 

[9]                                 Stock based compensation:

 

The Company recognizes compensation cost relating to share-based payment transactions in net loss using a fair-value measurement method, in accordance with ASC-718 Compensation-Stock Compensation. ASC-718 requires all share based payments to employees, including grants of employee stock option, to be recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. The Company determines the fair value of share-based awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield, expected forfeiture rate and expected life of the options. The Company has also granted stock options to nonemployees. Grants to non-employees are accounted for in accordance with ASC-505-50 Equity—Based Payments to Non-Employees. The Company determines the fair value of share based awards granted to nonemployees similar to the way fair value of awards are determined for employees except that certain assumptions used in the Black-Scholes option-pricing model, such as expected life of the option, maybe different and the fair value of each award is adjusted at the end of each period for any change in fair value from the previous valuation until the award vests.

 

[10]                          Earnings Per Share:

 

Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income (loss) available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there are a significant number of common stock options outstanding, fluctuations in the actual market price could have a variety of results for each period presented. No potentially dilutive equity instruments were included in the computations of diluted earnings per share for the three months ended March 31, 2014 or 2013 or for the period from May 25, 2004 (inception) to March 31, 2014 because their effect would be anti-dilutive as a result of losses incurred during those periods. Shares issuable upon the exercise of options outstanding at March 31, 2014 and 2013 were 810,863 and 473,805, respectively. As of March 31, 2014, the Company had also issued 24,000 Restricted Stock Units (RSU).

 

NOTE C—PROPERTY AND EQUIPMENT

 

Property and equipment as of March 31, 2014 and December 31, 2013 consisted of:

 

 

 

Useful Life

 

2014

 

2013

 

Computer equipment

 

3 years

 

$

54,646

 

$

50,730

 

Furniture and fixtures

 

7 years

 

66,275

 

66,275

 

 

 

 

 

120,921

 

117,005

 

Less accumulated depreciation

 

 

 

(106,932

)

(106,179

)

Property and equipment, net

 

 

 

$

13,989

 

$

10,826

 

 

For the three months ended March 31, 2014 and 2013 depreciation expense was approximately $750 and $3,100, respectively. Depreciation expense for the period from May 25, 2004 (inception) to March 31, 2014 was approximately $106,900.

 

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NOTE D—NOTES PAYABLE

 

During the period from May 25, 2004 (inception) to December 31, 2006 certain stockholders lent the Company an aggregate of approximately $1.7 million. In connection therewith, the Company executed numerous agreements (“Notes”) that provided the lenders with various rights and preferences including interest at rates ranging from 7.75% to 11.25%, security interest in all the assets of the Company and conversion rights into preferred stock. Certain Notes issued in 2006 contained beneficial conversion features (“BCF”) whereby upon conversion of the convertible note into preferred stock, the holder received a favorable exchange rate that was accounted for as additional interest expense. The BCF totaled $560,000 and was recognized as additional interest expense amortized over the life of the Notes.

 

On May 4, 2007, all the Notes, and the related accrued and unpaid interest was converted into shares of Series A Preferred Stock (Note E).

 

During 2011, the Company sold convertible promissory notes for approximately $2,100,000 in aggregate to shareholders of the Company.

 

During 2012, the Company sold convertible promissory notes for approximately $1,255,000 in aggregate to shareholders of the Company.

 

During 2013, the Company sold convertible promissory notes for approximately $4,562,000 in aggregate to shareholders of the Company.

 

On February 14, 2014, in connection with the closing of the Company’s initial public offering, the convertible promissory notes and accrued interest were converted into 1,197,289 shares of common stock.

 

The Company had accrued interest of approximately $0 and $650,000 as of March 31, 2014 and December 31, 2013, respectively, which is included in accrued and other liabilities on the accompanying balance sheets. Interest expense relating to the notes was approximately $78,000 and $71,000 for the three months ended March 31, 2014 and 2013, respectively, and approximately $1.5 million for the period from May 25, 2004 (inception) to March 31, 2014.

 

NOTE E—STOCKHOLDERS’ EQUITY (DEFICIENCY)

 

Series A Preferred Stock

 

May 2007 Stock Purchase Agreement

 

On May 4, 2007, the Company entered into a Stock Purchase Agreement (the “Agreement”) with new and existing stockholders. The terms of the agreement provided for the initial issuance of approximately 4.8 million shares of Series A stock (the “First Close”) in exchange for cash of $1.5 million, conversion of the Notes, including accrued interest, of $2.3 million, and the acquisition of certain technology from BioStratum, Inc (“Bio”). The Agreement also provided for a second and third close (referred to individually as “Warrant 1” and “Warrant 2”, respectively, or collectively as “Warrants”) whereby certain investors in the First Close were given a right, but not the obligation, to purchase additional shares of Series A and common stock at defined prices. The value assigned to the acquired technology from Bio was approximately $1.1 million. Such amount was expensed as research and development expense at the time the First Close was completed since the acquired technology will be used in the Company’s research efforts and had no alternative future use. For financial reporting purposes, the First Close was accounted for as the issuance of 4.8 million shares of Series A stock and two warrants (Warrant 1 and 2) in consideration for cash, conversion of the Notes and acquired technology.

 

The table below summarizes the allocation of the consideration received to the financial instruments issued in the First Close.

 

Consideration received

 

 

 

Cash

 

$

1,500,000

 

Conversion of the Notes and accrued interest (See Note D)

 

2,313,772

 

Acquired technology

 

1,093,339

 

 

 

$

4,907,111

 

Allocation to financial instruments

 

 

 

Series A stock

 

$

2,503,323

 

Preferred stock warrant liability

 

2,403,788

 

 

 

$

4,907,111

 

 

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Warrants

 

Warrant 1, as amended, provided the holder the right, but not the obligation, to purchase up to an additional 18 million shares of Series A stock and 45,234 shares of common stock in consideration for $20.0 million. Warrant 1 was exercised in part during December 2007 and fully exercised during March 2008. In connection with the partial exercise of Warrant 1 in December 2007, the Company issued approximately 1.8 million shares of Series A stock in exchange for $2.0 million. In March 2008, the holders of Warrant 1 exercised their remaining right to acquire 16 million shares of Series A stock and 45,234 common shares in consideration for approximately $18.0 million. As discussed below, the deemed fair value of Warrant 1 at the date of issuance through the date of exercise was accounted for as a preferred stock warrant liability.

 

Upon the partial exercise of Warrant 1 in December 2007, approximately $245,000 of the prorated share of the deemed fair value of Warrant 1 at the time of exercise attributable to the Series A stock issued was reclassified from the preferred stock warrant liability to additional paid-in capital and accounted for as additional consideration received in connection with the partial exercise of Warrant 1. In March 2008, the balance of the preferred stock warrant liability for Warrant 1, of approximately $2.2 million, was reclassified from preferred stock warrant liability to additional paid-in capital and accounted for as additional consideration received.

 

The fair value of the Warrants was estimated on the date of issuance using the Black-Scholes option pricing model. The Company accounted for the Warrants in accordance with the provisions of ASC-480 and other accounting standards. The Company recorded the fair value of the Warrants as a liability on its balance sheet until the Warrants expired or were exercised. The Warrants were revalued to their then estimated fair value, using the Black-Scholes model, at each reporting period end through December 31, 2012, and the Probability Weighted Expected Return Method calculated with the assistance of a third party valuation firm as of December 31, 2013, and any change in the fair value of the Warrants was reflected in operating results. The assumptions used in the Black-Scholes model to value the Warrants from their May 4, 2007 date of issuance through December 31, 2012 was a term ranging from 1 to 4 years, a risk free interest rate of approximately 0.185% to 3.36%, volatility of 60%, and the fair value of the Series A stock ranging from $1.11 to $1.39.

 

On January 16, 2014, an agreement was reached among the Company’s significant shareholders to cancel Warrant 2 held by its majority shareholder, Care Capital Investments III, LP, together with its affiliates (collectively, Care Capital), and by funds affiliated with Rho Venture Partners (Rho). Pursuant to this agreement, an aggregate of 593,589 shares of the Company’s common stock were issued to Care Capital and Rho concurrently with the completion of the Company’s initial public offering in return for cancelling Warrant 2. In connection with the issuance of the shares referenced above and the cancellation of Warrant 2, the Company settled the preferred stock warrant liability on its balance sheet on February 14, 2014.

 

The table below summarizes the changes in the fair value measurements of the Warrants, which used significant unobservable inputs (Level 3), from their issuance date (May 4, 2007) to March 31, 2014:

 

Warrants deemed fair value at issuance

 

$

2,403,788

 

Reclassification to additional paid-in capital upon partial Warrant 1 exercise

 

(245,402

)

Change in deemed fair value of the Warrants during 2007

 

4,463,509

 

Deemed fair value of warrants at December 31, 2007

 

6,621,895

 

Reclassification to additional paid-in capital upon remaining Warrant 1 exercise

 

(2,213,480

)

Change in deemed fair value of the Warrants during 2008

 

941,639

 

Deemed fair value of warrants at December 31, 2008

 

5,350,054

 

Change in deemed fair value of the Warrants during 2009

 

(950,641

)

Deemed fair value of warrants at December 31, 2009

 

4,399,413

 

Change in deemed fair value of the Warrants during 2010

 

 

Deemed fair value of warrants at December 31, 2010

 

4,399,413

 

Change in deemed fair value of the Warrants during 2011

 

(835,411

)

Deemed fair value of warrants at December 31, 2011

 

3,564,002

 

Change in deemed fair value of the Warrants during 2012

 

1,800

 

Deemed fair value of warrants at December 31, 2012

 

3,565,802

 

Change in deemed fair value of the Warrants during 2013

 

3,416,838

 

Deemed fair value of warrants at December 31, 2013

 

6,982,640

 

Change in deemed fair value of the Warrants during 2014

 

140,428

 

Settlement of warrant liability during 2014

 

(7,123,068

)

Deemed fair value of warrants at March 31, 2014

 

$

 

 

On February 10, 2014, the Company, in connection with the IPO, issued the underwriter warrants to purchase up to 62,000 shares of common stock. The warrants are exercisable at any time, in whole or in part, during the four-year period commencing one year from the effective date of the Company’s initial public offering. The warrants are exercisable at a price of $15.00 per share. The exercise price and number of shares issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend or the Company’s recapitalization, reorganization, merger or consolidation. However, the warrant exercise price or underlying shares will not be adjusted for issuances of shares of common stock at a price below the warrant exercise price.

 

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Common Stock

 

On February 6, 2014, the Company effected a 1-for-6.5 reverse stock split of its issued and outstanding shares of common stock and a proportional adjustment to the conversion ratio for each series of Series A Preferred Stock. Accordingly, all share and per share amounts for all periods presented in these financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the reverse stock split and adjustment of the preferred share conversion ratios.

 

On February 14, 2014, the Company filed an Amended and Restated Certificate of Incorporation which authorizes the issuance of 100,000,000 shares of common stock, and 5,000,000 shares of undesignated preferred stock.

 

On February 14, 2014, the Company closed its initial public offering of 3,100,000 shares of common stock at a price of $12.00 per share for total gross proceeds of $37.2 million, less underwriting discounts, commissions and offering expenses of approximately $3.8 million. In connection with the completion of the offering, 3,644,354 shares of common stock were issued for the conversion of all outstanding shares of Series A Preferred stock, 1,197,289 shares of common stock were issued for the convertible notes and accrued interest and 593,589 aggregate shares of common stock were issued in connection with the settlement of Warrant 2.

 

NOTE F—STOCK OPTION PLAN

 

In 2005, the Company adopted the NephroGenex, Inc. 2005 Stock Option Plan (the “Plan”). The Plan, as amended, and subject to shareholder approval of an increase of 673,923 shares, provides for the granting of up to 1,283,226 shares of common stock to employees and consultants of the Company in the form of incentive and nonqualified stock options and shares of restricted stock. Options and restricted stock vest over various periods ranging from eight months to four years. All options expire ten years from grant date. Shares available for future grant at March 31, 2014 total 472,363. The table below summarizes stock option activity from the Plan’s inception through March 31, 2014.

 

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Number
of Shares

 

Weighted
Average
Exercise
Price

 

Exercisable
at March 31,
2014

 

Granted

 

2,489

 

$

32.50

 

1,260

 

Outstanding as of December 31, 2005

 

2,489

 

32.50

 

 

 

Granted

 

52,659

 

0.65

 

53,535

 

Exercised

 

 

 

 

 

Cancelled

 

 

 

 

 

Outstanding as of December 31, 2007

 

55,148

 

2.08

 

 

 

Granted

 

284,915

 

0.39

 

303,154

 

Exercised

 

 

 

 

 

Cancelled

 

(2,000

)

0.39

 

 

 

Outstanding as of December 31, 2008

 

338,063

 

0.65

 

 

 

Granted

 

114,500

 

1.95

 

390,949

 

Exercised

 

 

 

 

 

Cancelled

 

(18,965

)

0.98

 

 

 

Outstanding as of December 31, 2009

 

433,598

 

0.98

 

 

 

Granted

 

 

 

390,949

 

Exercised

 

(10,476

)

0.39

 

 

 

Cancelled

 

 

 

 

 

Outstanding as of December 31, 2010

 

423,122

 

0.98

 

 

 

Granted

 

90,305

 

1.82

 

448,152

 

Exercised

 

 

 

 

 

Cancelled

 

(1,538

)

0.39

 

 

 

Outstanding as of December 31, 2011

 

511,889

 

1.17

 

 

 

Granted

 

 

 

 

 

Exercised

 

 

 

 

 

Cancelled

 

(38,084

)

1.50

 

448,152

 

Outstanding as of December 31, 2012

 

473,805

 

1.11

 

 

 

Granted

 

91,261

 

2.02

 

 

 

Exercised

 

 

 

 

 

Cancelled

 

(1,613

)

32.50

 

 

 

Outstanding as of December 31, 2013

 

563,453

 

 

1.17

 

478,572

 

Granted

 

247,410

 

10.28

 

 

 

Exercised

 

 

 

 

 

Cancelled

 

 

 

 

 

Outstanding as of March 31, 2014

 

810,863

 

$

3.96

 

512,186

 

 

As of March 31, 2014, there were 512,186 options exercisable with a weighted average exercise price of $1.60 and a weighted average remaining term of 4.9 years.

 

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The Company determines the fair value of stock options using the Black-Scholes option pricing model. The assumptions used to value stock options from the Company’s inception to March 31, 2014, included expected terms ranging 4 to 10 years, risk free interest rate of approximately 2%, volatility of 60% to 80%, zero dividend yield and an estimated fair value of a share of common stock ranging from $0.39 to $12.00. Total unrecognized compensation costs related to unvested awards at March 31, 2014 was approximately $2.2 million and is expected to be recognized within future operating results over a weighted average period of approximately 4.0 years. Stock based compensation expense for the three months ended March 31, 2014 and 2013 was approximately $94,000 and $24,000, respectively. Stock based compensation expense for the period from May 25, 2004 (inception) to March 31, 2014 was approximately $810,000.

 

In November 2013, the Company issued 24,000 Restricted Stock Units (RSU) to its CEO in connection with his employment agreement. These RSUs were not issued under the Plan. The RSU represent the right to receive shares of common stock, subject to the terms and conditions of a restricted stock unit agreement and grant notice.

 

As of March 31, 2014, none of the RSU had vested. The fair value of the RSU was estimated to be approximately $109,000, on the date of grant, which is being recognized over the four year vesting period of the RSU. For the three months ended March 31, 2014 and for the period from May 25, 2004 (Inception) to March 31, 2014, the Company recognized approximately $6,800 and $11,000, respectively, of stock based compensation. Total unrecognized compensation costs related to the RSU at March 31, 2014 was approximately $98,000, which is expected to be recognized within future operating results over a period of approximately 3.5 years.

 

On February 14, 2014, the Company’s Board of Directors granted 247,410 stock options to employees and Directors of the Company subject to shareholder approval of an increase in shares eligible for issuance under the Plan.  For accounting purposes, the Company determined these options to have been granted due to the fact that the Company’s Board of Directors controls greater than a majority of the Company’s outstanding common shares.

 

NOTE G—LICENSE AGREEMENTS

 

[1]                                 BioStratum, Inc.

 

On May 8, 2006, the Company entered into a licensing agreement with Bio Stratum Incorporated (“Bio”) for exclusive rights to use certain technology. The agreement was amended on September 13, 2006 (the “2006 Bio Agreement”) and was superseded on May 4, 2007 by the Termination, Assignment, Assumption and Participation Agreement (the “2007 Bio Agreement”). In consideration for obtaining the licensed technology in 2006, the 2006 Bio Agreement provided for the issuance of 12,708 shares of common stock as defined and the payment of an upfront licensing fee of $500,000. The licensing fee was expensed during 2006 as research and development as the licensed technology will be used in the Company’s research efforts and had no alternative future use. The fair value of the 12,708 shares of common stock issued to Bio totaled approximately $5,000. The 2006 Bio Agreement contained numerous other terms and conditions substantially all of which were superseded by the 2007 Bio Agreement. The 2007 Bio Agreement provided for the Company to issue approximately 1.8 million shares of Series A stock and to issue approximately 208,000 shares of common stock contingent on the exercise of Warrant 1 (Note E). The estimated fair value of the 1.8 million shares of Series A stock totaled approximately $1.1 million and was expensed upon issuance as research and development as the licensed technology will be used in the Company’s research efforts and had no alternative future use. As discussed in Note E, in March 2008, the balance of Warrant 1 was fully exercised and Bio received approximately 208,000 shares of common stock as additional consideration for the licensed technology. The estimated fair value of the shares of common stock issued totaled approximately $81,000 and was expensed in 2008 upon issuance as research and development expense as the licensed technology will be used in the Company’s research efforts and had no alternative future use.

 

The Company recognized no expense for the Bio Agreement for the three months ended March 31, 2014 and 2013 and $1.1 million for the period May 25, 2004 (inception) to March 31, 2014, respectively.

 

[2]                                 Vanderbilt University

 

During 2006, the Company entered into a licensing agreement with Vanderbilt University (“Vanderbilt”) for the rights to use certain technology. The agreement, as amended, requires the Company to make milestone payments totaling approximately $1.1 million based upon certain events as defined in the agreement. Should the Company successfully develop a product using the licensed technology, Vanderbilt will be due royalties based on net sales at a rate of 5%. The Company must also pay Vanderbilt 25% of non-royalty sub-licensee payments received from a sub-licensee. Certain milestones can be

 

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paid in stock or are creditable against future royalties due based on net sales. As of March 31, 2014, no milestone or royalty payments have been paid or accrued.

 

Annual minimum royalties due under the licensing agreement are $10,000 and will increase to $25,000 when a claim in the licensed patent rights is issued in a major market country, as defined. The licensing agreement expires when the underlying patents to the licensed technology expire. The Company may terminate the agreement upon 60 days written notice to Vanderbilt. In consideration for the license, the Company issued 462 shares of common stock and granted Vanderbilt the right to maintain their ownership interest at 2.5% (the “Right”) for the period to a private financing, as defined. The estimated value of the 462 shares of common stock and the Right totaled approximately $7,000, which was expensed as research and development as the licensed technology will be used in the Company’s research efforts and has no alternative future use. The licensing agreement was amended in 2007 and provided for the settlement of the Right in exchange for 17,257 shares of common stock. The amendment also obligated the Company to issue an additional 24,014 shares of common stock contingent on the exercise of Warrant 1.

 

As discussed in Note E, during March 2008, the balance of Warrant 1 was fully exercised, and accordingly, Vanderbilt received 24,014 shares of common stock as additional consideration for the licensed technology. The estimated fair value of the shares of common stock totaled approximately $9,000, which was expensed upon issuance as research and development as the licensed technology will be used in the Company’s research efforts and had no alternative future use. For all periods presented, expenses recognized in connection with Vanderbilt were not material.

 

[3]                                 Tryggvason Biotech AB:

 

During 2005, the Company entered into a licensing agreement with Tryggvason Biotech AB and Handelsbolaget Christer Betsholtz (collectively “Tryggvason”) for the exclusive commercial rights to use their proprietary glomerular profiling technology. The agreement included an upfront payment of $5,000 and a commitment to issue 151 shares of common stock. The licensing fee was expensed as research and development as the licensed technology will be used in the Company’s research efforts and has no alternative future use. The fair value of the 151 shares of common stock issued was insignificant at the time of issuance. Tryggvason will be due royalties based on 2% of net sales, as defined. No royalties have been paid or accrued through March 31, 2014. The licensing agreement expires upon the expiration of the underlying patents.

 

[4]                                 FibroStatin SL:

 

During 2005, the Company entered into a licensing agreement with FibroStatin SL, for exclusive commercial rights to their proprietary technology. The agreement included an upfront payment of $5,000 and a commitment to issue FibroStatin 153 shares of common stock. The licensing fee was expensed as research and development as the licensed technology will be used in the Company’s research efforts and has no alternative future use. The fair value of the 153 shares of common stock issued was insignificant at the time of issuance. This licensing agreement was terminated on April 12, 2007.

 

[5]                                 The University of Kansas Medical Center Research Institute, Inc.:

 

During 2007, Bio assigned their rights to certain technology licensed from the University of Kansas Medical Center Research Institute, Inc. (“KUMC”) to the Company. The license gives the Company worldwide royalty free rights to use certain technology. Upon the achievement of certain defined product development milestones, the Company would be obligated to make up to $225,000 of payments to KUMC. The term of the agreement expires on the expiration of the underlying KUMC patents or November 2018, whichever occurs last. The Company can terminate the agreement with 90 days notice. As of March 31, 2014, no milestones have been paid or accrued.

 

[6]                                 The University of South Carolina Research Foundation, Corp.:

 

During 2007, Bio assigned their rights to certain technology licensed from the University of South Carolina Research Foundation, Corp. (“USCRF”) to the Company. The license gives the Company worldwide rights to use certain technology. The agreement was amended in August 2013. The Company is obligated to pay an annual licensing fee of $30,000 through 2008, $60,000 from 2009 through 2010, $62,000 from 2011 through 2012, $122,000 in 2013 and $120,000 thereafter. Upon the achievement of certain defined product development milestones, the Company would be obligated to make up to $6.1 million of payments to USCRF. The Company will be obligated to pay USCRF a one-time fee of $35,000 upon execution of a sublicense and would pay to USCRF 25% of any non-royalty sublicense payments received from a sub-licensee. The term of the agreement expires on the expiration of the underlying USCRF patents. The Company can terminate the license at any time upon three months prior written notice to USCRF.  As of March 31, 2014, no development

 

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milestones have been paid or accrued nor does the Company expect to achieve any development milestones during the next few years.

 

NOTE H—RECENT ACCOUNTING PRONOUNCEMENTS

 

Occasionally, new accounting standards are issued or proposed by the Financial Accounting Standards Board (the “FASB”), or other standards-setting bodies that the Company adopts by the effective date specified within the standard. Unless otherwise discussed, standards that do not require adoption until a future date are not expected to have a material impact on the Company’s financial statements upon adoption.

 

In February 2013, the FASB issued a final rule related to the reporting of amounts reclassified out of accumulated other comprehensive income that requires entities to report, either on their income statement or in a footnote to their financial statements, the effects on earnings from items that are reclassified out of other comprehensive income. The new accounting rule was effective for the Company in the first quarter of 2013. The adoption of the new accounting rule did not have a material effect on the Company’s financial condition, results of operations or cash flows. The Company chose to present the total of comprehensive income, the components of net income, and the components of other comprehensive income in a single continuous statement of operations and comprehensive income.

 

In July 2013, the FASB issued Accounting Standards Update, or ASU, No. 2013-11, Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists. ASU 2013-11 provides explicit guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. The guidance is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013, with an option for early adoption. The Company adopted this guidance on January 1, 2014. The adoption did not impact the Company’s financial position or results of operations.

 

NOTE I—COMMITMENTS

 

Lease

 

The Company’s operating lease agreement in Research Triangle Park, North Carolina expired in December 2013, and the Company is currently leasing the space on a month-to-month basis.

 

For the three months ended March 31, 2014 and 2013 and for the cumulative period from May 25, 2004 (inception) to March 31, 2014, rent expense was approximately $13,000, $13,000, and $551,000, respectively.

 

NOTE J—RELATED PARTY TRANSACTIONS

 

From time to time, the Company reimbursed Care Capital, LLC (“Care”), an affiliate of the majority shareholder of the Company, for certain expenses paid by Care on behalf of the Company. During 2007, the Company reimbursed Care approximately $80,000 for expenses incurred by Care in connection with the May 2007 Stock Purchase Agreement (Note E).

 

The Company uses the services of a Care employee and reimburses Care for such personnel services incurred by Care on behalf of the Company. For the three months ended March 31, 2014 and 2013 and the cumulative period from May 25, 2004 (inception) to March 31, 2014, the total expense recognized in operating results in connection with services provided by Care was $50,000, $24,000 and $714,000, respectively.

 

As discussed in Note G, the Company has entered into license and royalty agreements with certain shareholders of the Company.

 

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NOTE K—QUALIFIED THERAPEUTIC DISCOVERY PROGRAM AWARD

 

In 2010, the Company was awarded approximately $244,000 under the Federal government Qualifying Therapeutic Discovery Program (“QTDP”) initiative, all of which is included in other income in the accompanying statement of operations for the period from May 25, 2004 (inception) through March 31, 2014.

 

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Item 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 consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in the forward-looking statements as a result of certain factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this quarterly report or in our Annual Report on Form 10-K.

 

Overview

 

We are a pharmaceutical company focused on the development of therapeutics to treat kidney disease, an area of significant unmet medical need. Since our inception, we have collaborated with the world’s leading experts in kidney disease and leveraged our knowledge of pathogenic oxidative chemistries to build a strong portfolio of intellectual property and to advance the development of our drug candidates. We believe that our comprehensive effort to develop a new generation of therapeutics that target kidney disease provides us with a leadership position in this large and attractive market.

 

We have devoted substantially all of our resources to development efforts relating to our product candidate, including conducting clinical trials of our product candidate, providing general and administrative support for these operations and protecting our intellectual property. We do not have any products approved for sale and have not generated any revenue from product sales. From May 25, 2004 our inception, until March 31, 2014, we have funded our operations primarily through proceeds from our initial public offering, or IPO, and the private placement of preferred stock, common stock and convertible notes totaling $69.2 million. In February 2014, we completed our IPO pursuant to a registration statement on Form S-1. In the IPO, we sold 3,100,000 shares of our common stock at a public offering price of $12.00 per share and received net proceeds of approximately $33.4 million, after underwriting discounts, commissions and offering expenses.

 

We have incurred net losses in each year since our inception in 2004. Our net losses were approximately $1.7 million and $0.5 million for the three months ended March 31, 2014 and 2013, respectively. As of March 31, 2014, we had an accumulated deficit of approximately $42.7 million. Substantially all of our net losses resulted from costs incurred in connection with our research and development programs, from general and administrative costs associated with our operations and as a result of a change in value of preferred stock warrants.

 

We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We anticipate that our expenses will increase substantially as we:

 

·                  complete the development of our lead product candidate, Pyridorin, for the treatment of diabetic nephropathy in patients with type 2 diabetes;

 

·                  complete the development of an intravenous formulation of Pyridorin for the treatment of acute kidney injury (AKI);

 

·                  seek to obtain regulatory approvals for Pyridorin;

 

·                  outsource the commercial manufacturing of Pyridorin for any indications for which we receive regulatory approval;

 

·                  contract with third parties for the sales, marketing and distribution of Pyridorin for any indications for which we receive regulatory approval;

 

·                  maintain, expand and protect our intellectual property portfolio;

 

·                  continue our research and development efforts;

 

·                  add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts; and

 

·                  operate as a public company.

 

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We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain marketing approval for one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. Accordingly, we anticipate that we will need to raise additional capital prior to the commercialization of Pyridorin or any other product candidate. Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our operating activities through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability to develop our product candidates.

 

Financial Overview

 

Revenue

 

We did not have any revenue during the period from May 25, 2004 (inception) through March 31, 2014. Our ability to generate revenue in the future will depend almost entirely on our ability to successfully develop, obtain regulatory approval and commercialize Pyridorin in the United States.

 

Research and Development Expenses

 

Since our inception, we have focused our resources on our research and development activities, including conducting nonclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory filings for Pyridorin. We recognize research and development expenses as they are incurred. Our research and development expenses consist primarily of:

 

·                  salaries and related overhead expenses for personnel in research and development functions;

 

·                  fees paid to consultants and CROs, including in connection with our nonclinical and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis;

 

·                  costs related to acquiring and manufacturing clinical trial materials;

 

·                  depreciation of leasehold improvements, laboratory equipment and computers;

 

·                  costs related to compliance with regulatory requirements; and

 

·                  costs related to stock options or other stock-based compensation granted to personnel in research and development functions.

 

From inception through March 31, 2014, we have incurred approximately $29.5 million in research and development expenses. We plan to increase our research and development expenses for the foreseeable future as we continue the development of Pyridorin for the treatment of diabetic nephropathy in patients with type 2 diabetes and other indications, subject to the availability of additional funding.

 

The table below summarizes our direct research and development expenses for Pyridorin for the periods indicated. Our direct research and development expenses consist principally of external costs, including fees paid to investigators, consultants, central laboratories and CROs, in connection with our clinical trials, and costs related to acquiring and manufacturing clinical trial materials. We do not allocate salaries, stock-based compensation, employee benefit or other indirect costs related to our research and development function to specific product candidates. Those expenses are included in “Indirect research and development expense” in the table below.

 

 

 

Three Months Ended March 31,

 

 

 

2014

 

2013

 

Direct research and development expense

 

$

 

$

7,841

 

Personnel costs

 

369,847

 

185,128

 

Indirect research and development expense

 

87,529

 

71,591

 

Total research and development expense

 

$

457,376

 

$

264,560

 

 

The successful development of our clinical and preclinical product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of any of our clinical or preclinical product candidates or the period, if any, in which material net cash inflows from these product candidates may commence. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

 

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·                  the scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;

 

·                  future clinical trial results; and

 

·                  the timing and receipt of any regulatory approvals.

 

A change in the outcome of any of these variables with respect to the development of a product candidate could result in a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development of a product candidate or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

 

Pyridorin

 

The majority of our research and development resources are focused on the Phase 3 Pyridorin program and our other planned clinical and nonclinical studies and other work needed to submit Pyridorin for the treatment of diabetic nephropathy in patients with type 2 diabetes for regulatory approval in the United States and Europe. We have incurred and expect to continue to incur expense in connection with these efforts, including:

 

·                  working with our CRO to prepare for launch of the Phase 3 trial;

 

·                  working with third-party service providers to produce sufficient clinical trial supply for our Phase 3 program and other contemplated trials; and

 

·                  working with our CRO to conduct a Phase 1 QT interval (TQT) trial.

 

In addition, we are evaluating the application of an intravenous formulation of Pyridorin to specific types of acute renal failure in which pathogenic oxidative chemistries have been identified as likely causative factors in the onset, severity and progression of this condition. These include contrast-dye-induced acute renal failure and ischemia-reperfusion acute renal injury, which can arise in cardiac and vascular surgeries. In connection with these efforts, we have incurred and expect to incur significant expenses relating to:

 

·                  working with research institutions with expertise using animal models of various types of acute renal injury to conduct studies to determine where Pyridorin would have the most beneficial effect in ameliorating the severity and progression of the induced acute renal injury; and

 

·                  working with a third-party drug formulator to produce intravenous Pyridorin solutions for preclinical and clinical studies.

 

General and Administrative Expenses

 

General and administrative expenses consist primarily of salaries and related costs for employees in executive, and finance functions. Other significant general and administrative expenses include facilities costs, professional fees for directors, accounting and legal services and insurance.

 

We expect that our general and administrative expenses will increase as we continue to operate as a public company including increased costs for director and officer liability insurance, costs related to the hiring of additional personnel and increased fees for consultants, lawyers and accountants.

 

Other Income

 

Other income consists of interest income earned on our cash and cash equivalents, interest expense pertaining to interest accrued on our convertible notes and the change in value of our preferred stock warrant liability.

 

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Critical Accounting Policies and Estimates

 

The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and expenses incurred during the reported periods. On an ongoing basis, we evaluate our estimates and judgments related to preclinical, nonclinical and clinical development costs and drug manufacturing costs. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We discussed accounting policies and assumptions that involve a higher degree of judgment and complexity in the notes to our audited financial statements our Management’s Discussion and Analysis of Financial Condition and Results of Operations as filed in our Annual report on  Form 10-K for the year ended December 31, 2013.  There have been no material changes to our critical accounting policies and estimates as disclosed in our notes to our audited financial statements.

 

JOBS Act

 

On April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (the Securities Act), for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This election allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates.

 

We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1 billion or more; (ii) December 31, 2019; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission.

 

Results of Operations

 

Comparison of the Three Months Ended March 31, 2014 and the Three Months Ended March 31, 2013

 

The following table summarizes our results of operations for each of the three months ended March 31, 2014 and 2013, together with the changes in those items in dollars and as a percentage:

 

 

 

Three Months Ended March 31,

 

Dollar

 

 

 

 

 

2014

 

2013

 

Change

 

% Change

 

Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

457,376

 

$

264,560

 

$

192,816

 

72.9

%

General and administrative

 

1,034,425

 

138,137

 

896,288

 

648.8

%

Loss from operations

 

(1,491,801

)

(402,697

)

1,089,104

 

270.5

%

Other income (expense):

 

 

 

 

 

 

 

 

 

Change in value of preferred stock warrants

 

(140,428

)

 

(140,428

)

%

Interest expense

 

(78,084

)

(71,303

)

(6,781

)

9.5

%

Interest income

 

9,997

 

176

 

9,821

 

5,580.1

%

Net loss

 

$

(1,700,316

)

$

(473,824

)

$

(1,226,492

)

258.8

%

 

Research and Development Expenses

 

Research and development expenses were $0.5 million and $0.3 million for the three months ended March 31, 2014 and 2013, respectively, representing an increase of approximately $0.2 million, or 72.9%. The increase in research and development expense is primarily due to clinical start-up activities as we initiate our Phase 3 PIONEER study of Pyridorin for the treatment of diabetic nephropathy.

 

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General and Administrative Expenses

 

General and administrative expenses were approximately $1.0 million and $0.1 million for the three months ended March 31, 2014 and 2013, respectively, representing an increase of approximately $0.9 million, or 648.8%. This increase in general and administrative expenses was primarily a result of an increase in personnel related expenses including non-cash compensation expense and an increase in our corporate governance expenses including our director and officer liability insurance and investor relation costs as we commenced operating as a public company in February of 2014.

 

Interest Expense, Net

 

Interest expense, net was approximately $0.1 million and $0.1 million for the three months ended March 31, 2014 and 2013, respectively. Interest expense was incurred for our convertible promissory notes which were converted into common stock upon closing of the IPO in February 2014.

 

Liquidity and Capital Resources

 

Sources of Liquidity

 

We have incurred losses and cumulative negative cash flows from operations since inception and as of March 31, 2014, we had an accumulated deficit of $42.7 million. We anticipate that we will continue to incur losses for at least the next several years. We expect that our research and development and general and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations, which we may seek to obtain through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

 

Since our inception, we have funded our operations principally with $69.2 million from the sale of common stock, preferred stock and convertible notes and approximately $244,000 from a government grant. As of March 31, 2014, we had cash and cash equivalents of approximately $33.5 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our funds are held in cash, money market bank accounts, and certificates of deposits held at various banks that do not exceed the Federal Deposit Insurance Corporation insurance limit.

 

The gross proceeds we have received from the issuance and sale of common stock, convertible notes and preferred stock, as of March 31, 2014, are as follows:

 

Securities Issued

 

Year

 

Number of
Shares

 

Gross
Proceeds

 

Convertible notes

 

2004 - 2013

 

 

$

9,471,870

 

Common stock

 

2004 - 2014

 

3,112,166

 

$

37,206,136

 

Series A preferred stock

 

2007/2008/2010

 

20,255,126

 

$

22,500,000

 

Total

 

 

 

23,367,292

 

$

69,178,006

 

 

On February 14, 2014, we closed our IPO of 3,100,000 shares of common stock at a price of $12.00 per share for total gross proceeds of $37.2 million, less underwriting discounts, commissions and offering expenses totaling $3.8 million.

 

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Cash Flows

 

The following table sets forth the significant sources and uses of cash for the periods set forth below:

 

 

 

Three Months Ended
March 31,

 

 

 

2014

 

2013

 

Net cash provided by (used in):

 

 

 

 

 

Operating activities

 

$

(2,082,917

)

$

(490,798

)

Investing activities

 

(3,916

)

 

Financing activities

 

33,468,237

 

512,048

 

Net increase in cash and cash equivalents

 

$

31,381,404

 

$

21,250

 

 

Operating Activities.

 

Net cash used in operating activities of $2.1 million during the three months ended March 31, 2014 was primarily due to our net losses from the operation of our business, including expenses incurred for the development of Pyridorin and changes in working capital, partially offset by non-cash interest expense for our convertible notes, share-based compensation expense and changes in the fair value of our preferred warrant liability. Cash used in operating activities for three months ended March 30, 2013 was primarily related to our net loss of $0.5 million during such period offset by changes in working capital and non-cash charges including interest for our convertible notes and share-based compensation expense.

 

Investing Activities.  Net cash used in investing activities during the three months ended March 31, 2014 related to purchases of equipment for our corporate offices.

 

Financing Activities.  Net cash provided by financing activities for the three months ended March 31, 2014 and 2013 consisted of approximately $33.4 million in net proceeds received from the issuance of common stock in our IPO and $0.5 million of net proceeds from the sale of convertible notes, respectively.

 

Future Funding Requirements

 

To date, we have not generated any revenue. We do not know when, or if, we will generate any revenue from product sales. We do not expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and commercialize Pyridorin or any of our other product candidates. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our product candidates. We expect to incur additional costs associated with operating as a public company. In addition, subject to obtaining regulatory approval of any of our product candidates, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need substantial additional funding in connection with our continuing operations.

 

Based upon our current operating plan and approximately $33.4 million of net proceeds received from our IPO completed in February 2014, we believe that our existing cash, cash equivalents and short-term investments, will enable us to fund our operating expenses and capital expenditure requirements into 2016. We intend to devote our cash to fund our Phase 3 Pyridorin program and our planned clinical trials and nonclinical studies and other work needed to submit applications for Pyridorin for the treatment of diabetic nephropathy in patients with type 2 diabetes for regulatory approval in the United States and Europe; to fund further preclinical and Phase 1 & 2 development work on an intravenous formulation of Pyridorin for AKI in which pathogenic oxidative chemistries have been identified as a possible contributing factor in the severity of this condition; and for general corporate purposes, general and administrative expenses, capital expenditures, working capital and prosecution and maintenance of our intellectual property. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our product candidates.

 

Our future capital requirements will depend on many factors, including:

 

·                  the progress, costs, results of and timing of our Phase 3 Pyridorin program for the treatment of diabetic nephropathy in patients with type 2 diabetes, and the clinical development of an intravenous formulation of Pyridorin for AKI;

 

·                  the willingness of the EMA or other regulatory agencies outside the U.S. to accept our Phase 3 Pyridorin program, as well as our other completed and planned clinical and nonclinical studies and other work, as the basis for review and approval of Pyridorin in the European Union for the treatment of diabetic nephropathy in patients with type 2 diabetes;

 

·                  the outcome, costs and timing of seeking and obtaining FDA, EMA and any other regulatory approvals;

 

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·                  the number and characteristics of product candidates that we pursue, including our product candidates in preclinical development;

 

·                  the ability of our product candidates to progress through clinical development successfully;

 

·                  our need to expand our research and development activities;

 

·                  the costs associated with securing and establishing commercialization and manufacturing capabilities;

 

·                  market acceptance of our product candidates;

 

·                  the costs of acquiring, licensing or investing in businesses, products, product candidates and technologies;

 

·                  our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

 

·                  our need and ability to hire additional management and scientific and medical personnel;

 

·                  the effect of competing technological and market developments;

 

·                  our need to implement additional internal systems and infrastructure, including financial and reporting systems; and

 

·                  the economic and other terms, timing of and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.

 

Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our cash needs through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, commercialization, marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.

 

Contractual Obligations and Commitments

 

There have been no material changes to our contractual obligations and commitments outside the ordinary course of business from those disclosed under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Contractual Obligations and Commitments” in our Annual Report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission.

 

Net Operating Losses

 

As of December 31, 2013, we had federal net operating loss carryforwards, or NOLs, of approximately $23.9 million which expire from 2024 through 2033. Our ability to utilize our NOLs may be limited under Section 382 of the Internal Revenue Code. The limitations apply if an ownership change, as defined by Section 382, occurs. Generally, an ownership change occurs when certain shareholders increase their aggregate ownership by more than 50 percentage points over their lowest ownership percentage in a testing period (typically three years). Although we have not undergone a Section 382 analysis, it is possible that the utilization of the NOLs, could be substantially limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be utilized against future taxes. As a result, we may not be able to take full advantage of these carryforwards for federal and state tax purposes. Future changes in stock ownership may also trigger an ownership change and, consequently, a Section 382 limitation.

 

Off-Balance Sheet Arrangements

 

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements as defined under the rules of the Securities and Exchange Commission.

 

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Item 3.  Quantitative and Qualitative Disclosures About Market Risk

 

Market Risk

 

Our cash and cash equivalents as of March 31, 2014, consisted primarily of cash, cash equivalents and money market funds. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of United States interest rates. However, because of the short-term nature of the instruments in our portfolio, a sudden change in market interest rates would not be expected to have a material impact on our financial condition and/or results of operations.

 

Item 4.  Controls and Procedures

 

(a) Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of March 31, 2014, have concluded that, based on such evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

 

(b) Changes in Internal Controls. There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such internal control that occurred during the quarter ended March 31, 2014 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II — OTHER INFORMATION

 

Item 1.  Legal Proceedings

 

From time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of our business. Any of these claims could subject the Company to costly legal expenses and, while the Company believes that it has adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage or our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the Company’s consolidated results of operations and financial position. Additionally, any such claims, whether or not successful, could damage our reputation and business. The Company is currently not a party to any legal proceedings.

 

Item 1A. Risk Factors

 

There have been no material changes in the risk factors described in “Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2013.

 

24



Table of Contents

 

Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3.    Defaults Upon Senior Securities

 

None.

 

Item 4.    Mine Safety Disclosures

 

Not applicable.

 

Item 5.    Other Information

 

None.

 

Item 6.    Exhibits

 

Exhibits required by Item 601 of Regulation S-K.

 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

31.1*

 

Certification of Principal Executive Officer Required Under Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended, and pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2*

 

Certification of Principal Financial Officer Required Under Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended, and pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32**

 

Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350.

101+

 

Financials in XBRL format

 


*Filed herewith

**Furnished herewith

 

+ Attached as Exhibits 101 to this report are the following financial statements from our Quarterly Report on Form 10-Q for the quarter ended March 31, 2014, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Statements of Comprehensive Income, (iii) the  Statements of Cash Flows and (iv) and related notes to these financial statements.

 

The XBRL related information in Exhibits 101 to this Quarterly Report on Form 10-Q shall not be deemed “filed” or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended (“Securities Act”) and is not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise subject to the liabilities of those sections.

 

25



Table of Contents

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

NEPHROGENEX, INC.

 

 

(Registrant)

 

 

 

Date: May 14, 2014

By:

/s/ Pierre Legault

 

 

Pierre Legault

Chief Executive Officer

(Principal Executive Officer)

 

 

 

 

 

 

Date: May 14, 2014

By:

/s/ John P. Hamill

 

 

John P. Hamill

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

26


EX-31.1 2 a14-11323_1ex31d1.htm EX-31.1

EXHIBIT 31.1

 

CERTIFICATION

 

I, Pierre Legault, certify that:

 

1.                          I have reviewed this Quarterly Report on Form 10-Q of NephroGenex, Inc.;

 

2.                          Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.                          Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.                          The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a)                         designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)                         [paragraph omitted in accordance with Exchange Act Rule 13a-14(a)];

c)                          evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)                         disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.                          The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a)                         all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b)                         any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

Date: May 14, 2014

/s/ Pierre Legault

 

Pierre Legault

 

Chief Executive Officer

(Principal Executive Officer)

 


 

EX-31.2 3 a14-11323_1ex31d2.htm EX-31.2

EXHIBIT 31.2

 

CERTIFICATION

 

I, John P. Hamill, certify that:

 

1.                          I have reviewed this Quarterly Report on Form 10-Q of NephroGenex, Inc.;

 

2.                          Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.                          Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.                          The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a)                         designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)                         [paragraph omitted in accordance with Exchange Act Rule 13a-14(a)];

c)                          evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)                         disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.                          The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a)                         all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b)                         any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

Date: May 14, 2014

/s/ John P. Hamill

 

John P. Hamill

 

Chief Financial Officer

(Principal Financial Officer)

 


 

EX-32 4 a14-11323_1ex32.htm EX-32

EXHIBIT 32

 

CERTIFICATION

 

Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of NephroGenex, Inc., a Delaware corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:

 

The Quarterly Report for the quarter ended March 31, 2014 (the “Form 10-Q”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

/s/ Pierre Legault

 

Pierre Legault

 

Chief Executive Officer

 

(Principal Executive Officer)

 

 

 

 

 

/s/ John P. Hamill

 

John P. Hamill

 

Chief Financial Officer

 

(Principal Financial Officer)

 

May 14, 2014

 

This certification is being furnished and not filed, and shall not be incorporated into any document for any purpose, under the Securities Exchange Act of 1934 or the Securities Act of 1933.

 


 

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Pursuant to this agreement, an aggregate of 593,589 shares of the Company&#8217;s common stock were issued to Care Capital and Rho concurrently with the completion of the Company&#8217;s initial public offering in return for cancelling Warrant 2. 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QUALIFIED THERAPEUTIC DISCOVERY PROGRAM AWARD (Details) (USD $)
118 Months Ended
Mar. 31, 2014
QUALIFIED THERAPEUTIC DISCOVERY PROGRAM AWARD  
Qualifying Therapeutic Discovery Program grant $ 244,479

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PROPERTY AND EQUIPMENT (Details) (USD $)
3 Months Ended 118 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Mar. 31, 2014
Dec. 31, 2013
Property and equipment, net        
Property and equipment $ 120,921   $ 120,921 $ 117,005
Less accumulated depreciation (106,932)   (106,932) (106,179)
Property and equipment, net 13,989   13,989 10,826
Depreciation expense 753 3,143 106,932  
Computer equipment
       
Property and equipment, net        
Property and equipment 54,646   54,646 50,730
Useful Life 3 years      
Furniture and fixtures
       
Property and equipment, net        
Property and equipment $ 66,275   $ 66,275 $ 66,275
Useful Life 7 years      
XML 16 R9.htm IDEA: XBRL DOCUMENT v2.4.0.8
SIGNIFICANT ACCOUNTING POLICIES
3 Months Ended
Mar. 31, 2014
SIGNIFICANT ACCOUNTING POLICIES  
SIGNIFICANT ACCOUNTING POLICIES

NOTE B—SIGNIFICANT ACCOUNTING POLICIES

 

[1]                                 Basis of presentation:

 

The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).

 

From its inception, the Company has devoted substantially all of its efforts to business planning, engaging regulatory, manufacturing and other technical consultants, acquiring operating assets, planning clinical trials and raising capital. The Company has experienced net losses since its inception and, as of March 31, 2014, had a deficit accumulated during the development stage of $42.7 million.

 

[2]                                 Use of estimates:

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

[3]                                 Segment reporting:

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment.

 

[4]                                 Cash and cash equivalents:

 

The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents.

 

[5]                                 Property and equipment:

 

Property and equipment consists of furniture, fixtures and computers. Property and equipment are carried at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the respective asset’s useful life. Maintenance and repairs that do not improve or extend the life of assets are expensed as incurred. When an asset is retired or disposed of, the cost and related accumulated depreciation are removed from the accounts and any resulting gains or losses are reflected within the statement of operations.

 

[6]                                 Fair value of financial instruments:

 

FASB ASC 820—Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. The estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments.

 

FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).

 

The three levels of the fair value hierarchy are as follows:

 

·                  Level 1—Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities.

 

·                  Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g. quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.

 

·                  Level 3—Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.

 

The carrying amounts reported in the balance sheet for cash and cash equivalents, accounts payable and accrued expenses approximate their fair value based on the short-term maturity of these instruments. The carrying amounts reported in the balance sheet for notes payable approximate their fair value based on market rates of interest and the terms of the notes. The Company recognizes all derivative financial instruments as assets or liabilities in the financial statements and measures them at fair value with changes in fair value reflected as current period income or loss unless the derivatives qualify as hedges. Certain terms of the May 4, 2007 Stock Purchase Agreement were accounted for as derivatives, which were valued under Level 3 of the fair value hierarchy. See Note E, Stockholders’ Equity (Deficit).

 

[7]                           Research and development costs:

 

Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities including non-cash share-based compensation, costs for third-party contractors to perform research, conduct clinical trials and prepare drug materials, research supplies and facilities costs. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered.

 

[8]                            Income taxes:

 

The Company utilizes the liability method of accounting for income taxes as required by FASB ASC Topic 740 Income Taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Uncertain tax positions are evaluated in accordance with this topic and if appropriate, the amount of unrecognized tax benefits are recorded within deferred tax assets. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.

 

ASC Topic 740 also clarifies the accounting for uncertainty in income taxes recognized in the financial statements. The interpretation prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. There were no significant matters determined to be unrecognized tax benefits taken or expected to be taken in a tax return that have been recorded in the Company’s financial statements through March 31, 2014. ASC Topic 740 provides guidance on the recognition of interest and penalties related to income taxes. There were no interest or penalties related to income taxes that have been accrued or recognized as of March 31, 2014 or for the three months ended March 31, 2014 or 2013, or for the period from May 25, 2004 (inception) to March 31, 2014. The Company has elected to treat interest and penalties, to the extent they arise, as a component of income taxes. Tax years beginning in 2010 for federal purposes are generally subject to examination by taxing authorities, although net operating losses from all prior years are subject to examinations and adjustments for at least three years following the year in which the tax attributes are utilized.

 

[9]                                 Stock based compensation:

 

The Company recognizes compensation cost relating to share-based payment transactions in net loss using a fair-value measurement method, in accordance with ASC-718 Compensation-Stock Compensation. ASC-718 requires all share based payments to employees, including grants of employee stock option, to be recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. The Company determines the fair value of share-based awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield, expected forfeiture rate and expected life of the options. The Company has also granted stock options to nonemployees. Grants to non-employees are accounted for in accordance with ASC-505-50 Equity—Based Payments to Non-Employees. The Company determines the fair value of share based awards granted to nonemployees similar to the way fair value of awards are determined for employees except that certain assumptions used in the Black-Scholes option-pricing model, such as expected life of the option, maybe different and the fair value of each award is adjusted at the end of each period for any change in fair value from the previous valuation until the award vests.

 

[10]                          Earnings Per Share:

 

Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income (loss) available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there are a significant number of common stock options outstanding, fluctuations in the actual market price could have a variety of results for each period presented. No potentially dilutive equity instruments were included in the computations of diluted earnings per share for the three months ended March 31, 2014 or 2013 or for the period from May 25, 2004 (inception) to March 31, 2014 because their effect would be anti-dilutive as a result of losses incurred during those periods. Shares issuable upon the exercise of options outstanding at March 31, 2014 and 2013 were 810,863 and 473,805, respectively. As of March 31, 2014, the Company had also issued 24,000 Restricted Stock Units (RSU).

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STOCK OPTION PLAN (Details) (USD $)
12 Months Ended 3 Months Ended 12 Months Ended 118 Months Ended 12 Months Ended 118 Months Ended 12 Months Ended 118 Months Ended 0 Months Ended 12 Months Ended 1 Months Ended 3 Months Ended 118 Months Ended
Dec. 31, 2005
Mar. 31, 2014
Mar. 31, 2014
Options
Mar. 31, 2013
Options
Dec. 31, 2013
Options
Dec. 31, 2012
Options
Dec. 31, 2011
Options
Dec. 31, 2010
Options
Dec. 31, 2009
Options
Dec. 31, 2008
Options
Dec. 31, 2007
Options
Dec. 31, 2005
Options
Mar. 31, 2014
Options
Dec. 31, 2005
Options
Minimum
Mar. 31, 2014
Options
Minimum
Dec. 31, 2005
Options
Maximum
Mar. 31, 2014
Options
Maximum
Feb. 14, 2014
Options
Employees and Directors
Dec. 31, 2005
RSU
Minimum
Dec. 31, 2005
RSU
Maximum
Nov. 30, 2013
RSU
CEO
Mar. 31, 2014
RSU
CEO
Mar. 31, 2014
RSU
CEO
STOCK OPTION PLAN                                              
Increase in number of shares authorized under the plan 673,923                                            
Number of shares authorized under the plan 1,283,226                                            
Vesting period                           8 months   4 years     8 months 4 years   4 years  
Expiration period 10 years                                            
Number of shares available for future grant   472,363                                          
Number of Shares                                              
Outstanding at the beginning of the period (in shares)     563,453 473,805 473,805 511,889 423,122 433,598 338,063 55,148                          
Granted (in shares)     247,410   91,261   90,305   114,500 284,915 52,659 2,489           247,410          
Exercised (in shares)               (10,476)                              
Cancelled (in shares)         (1,613) (38,084) (1,538)   (18,965) (2,000)                          
Outstanding at the end of the period (in shares)     810,863 473,805 563,453 473,805 511,889 423,122 433,598 338,063 55,148 2,489 810,863                    
Weighted Average Exercise Price                                              
Outstanding at the beginning of the period (in dollars per share)     $ 1.17 $ 1.11 $ 1.11 $ 1.17 $ 0.98 $ 0.98 $ 0.65 $ 2.08                          
Granted (in dollars per share)     $ 10.28   $ 2.02   $ 1.82   $ 1.95 $ 0.39 $ 0.65 $ 32.50                      
Exercised (in dollars per share)               $ 0.39                              
Cancelled (in dollars per share)         $ 32.50 $ 1.50 $ 0.39   $ 0.98 $ 0.39                          
Outstanding at the end of the period (in dollars per share)     $ 3.96   $ 1.17 $ 1.11 $ 1.17 $ 0.98 $ 0.98 $ 0.65 $ 2.08 $ 32.50 $ 3.96                    
Exercisable                                              
Exercisable at the end of the period (in shares)     512,186   478,572 448,152 448,152 390,949 390,949 303,154 53,535 1,260 512,186                    
Weighted average exercise price for exercisable options (in dollars per share)     $ 1.60                   $ 1.60                    
Weighted average remaining term for exercisable options     4 years 10 months 24 days                                        
Assumptions used to determine the fair value of the stock options                                              
Expected term                             4 years   10 years            
Risk free interest rate (as a percent)                         2.00%                    
Volatility (as a percent)                             60.00%   80.00%            
Dividend yield                         0.00%                    
Estimated fair value (in dollars per share)                             $ 0.39   $ 12.00            
Additional disclosure related to options                                              
Total unrecognized compensation costs     $ 2,200,000                   $ 2,200,000                    
Weighted average period for recognizing compensation cost     4 years                                     3 years 6 months  
Stock based compensation expense     94,000 24,000                 810,000                 6,800 11,000
Additional disclosure related to other than options                                              
Number of award issued (in shares)                                         24,000 24,000  
Awards vested (in shares)                                           0  
Fair value of units on date of grant                                           109,000  
Total unrecognized compensation costs                                           $ 98,000 $ 98,000
XML 19 R28.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCKHOLDERS' EQUITY (DEFICIENCY) (Details 2) (USD $)
0 Months Ended 3 Months Ended 118 Months Ended 12 Months Ended 0 Months Ended 3 Months Ended 0 Months Ended 0 Months Ended 3 Months Ended 12 Months Ended
Feb. 14, 2014
Mar. 31, 2014
Mar. 31, 2014
Dec. 31, 2013
Dec. 31, 2008
Warrant 1
Dec. 31, 2007
Warrant 1
Feb. 14, 2014
Common Stock
Feb. 06, 2014
Common Stock
Mar. 31, 2014
Common Stock
Feb. 10, 2014
Common Stock
Underwriter
May 04, 2007
Common Stock
Warrant 1
Feb. 14, 2014
Common Stock
Warrant 2
Jan. 16, 2014
Common Stock
Warrant 2
Mar. 31, 2014
Warrants
Dec. 31, 2013
Warrants
Dec. 31, 2012
Warrants
Dec. 31, 2011
Warrants
Dec. 31, 2009
Warrants
Dec. 31, 2008
Warrants
Dec. 31, 2007
Warrants
May 04, 2007
Warrants
Changes in the fair value of Warrants                                          
Deemed fair value of warrants at the beginning of the period                           $ 6,982,640 $ 3,565,802 $ 3,564,002 $ 4,399,413 $ 5,350,054 $ 6,621,895   $ 2,403,788
Reclassification to additional paid-in capital upon partial Warrant 1 exercise         (2,213,480) (245,402)                              
Change in deemed fair value of the Warrants   140,428 7,178,162                     140,428 3,416,838 1,800 (835,411) (950,641) 941,639 4,463,509  
Settlement of warrant liability                           (7,123,068)              
Deemed fair value of warrants at the end of the period                             6,982,640 3,565,802 3,564,002 4,399,413 5,350,054 6,621,895 2,403,788
Additional disclosure                                          
Reverse stock split ratio               0.1538                          
Warrants to purchase shares of common stock                   62,000 45,234   593,589                
Term of warrants                   4 years                      
Period from effective date of initial public offering until warrants are exercisable                   1 year                      
Warrants exercisable price per share (in dollars per share)                   $ 15.00                      
Common stock, shares authorized 100,000,000 100,000,000 100,000,000 100,000,000                                  
Preferred stock, shares authorized 5,000,000                                        
Stock issued (in shares) 3,100,000               3,100,000                        
Common stock price (in dollars per share) $ 12.00                                        
Total gross proceeds 37,200,000                                        
Issuance of common stock for preferred stock (unaudited) (in shares)             3,644,354   3,644,354                        
Issuance of common stock for all outstanding shares of series A preferred stock (in shares)             1,197,289   1,197,289                        
Payment of underwriting discounts, commissions and offering expenses $ 3,800,000 $ 3,731,763 $ 3,761,392                                    
Shares issued for cancellation of warrants             593,589   593,589     593,589                  
XML 20 R30.htm IDEA: XBRL DOCUMENT v2.4.0.8
LICENSE AGREEMENTS (Details) (USD $)
3 Months Ended 118 Months Ended 0 Months Ended 3 Months Ended 118 Months Ended 3 Months Ended 12 Months Ended 3 Months Ended 12 Months Ended 0 Months Ended 12 Months Ended 3 Months Ended 12 Months Ended 1 Months Ended 12 Months Ended 3 Months Ended 12 Months Ended 12 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Mar. 31, 2014
May 04, 2007
Series A Preferred Stock
Warrant 1
May 04, 2007
Common stock
Warrant 1
Sep. 13, 2006
BioStratum, Inc.
Mar. 31, 2014
BioStratum, Inc.
Mar. 31, 2013
BioStratum, Inc.
Mar. 31, 2014
BioStratum, Inc.
Mar. 31, 2014
BioStratum, Inc.
KUMC
Dec. 31, 2007
BioStratum, Inc.
KUMC
Mar. 31, 2014
BioStratum, Inc.
USCRF
Dec. 31, 2007
BioStratum, Inc.
USCRF
May 04, 2007
BioStratum, Inc.
Series A Preferred Stock
Sep. 13, 2006
BioStratum, Inc.
Common stock
Dec. 31, 2008
BioStratum, Inc.
Common stock
Dec. 31, 2006
BioStratum, Inc.
Common stock
May 04, 2007
BioStratum, Inc.
Common stock
Mar. 31, 2014
Vanderbilt
Dec. 31, 2006
Vanderbilt
Mar. 31, 2008
Vanderbilt
Common stock
Dec. 31, 2008
Vanderbilt
Common stock
Dec. 31, 2007
Vanderbilt
Common stock
Dec. 31, 2006
Vanderbilt
Common stock
Mar. 31, 2014
Tryggvason
Dec. 31, 2005
Tryggvason
Dec. 31, 2006
Tryggvason
Common stock
Dec. 31, 2005
Tryggvason
Common stock
Dec. 31, 2005
FibroStatin SL
Dec. 31, 2007
FibroStatin SL
Common stock
Dec. 31, 2005
FibroStatin SL
Common stock
LICENSE AGREEMENTS                                                              
Upfront payment           $ 500,000                                       $ 5,000     $ 5,000    
Fair value of shares issued                             5,000 81,000         9,000     7,000              
Estimated fair value of shares to be issued                           1,100,000                                  
Issuance of shares and warrant (Note G) (in shares)                                               461              
Number of shares of stock to be acquired       18,000,000 45,234                 1,800,000       208,000                   151     153
Number of shares received as additional consideration under agreement                                             17,257                
Number of shares received as consideration under agreement                               207,744 12,707         24,013         151     153  
License Costs 457,376 264,560 29,465,241       0 0 1,100,000                                            
Potential milestone payments                     225,000   6,100,000             1,100,000                      
Percentage of royalty based on net sales                                       5.00%           2.00%          
Percentage of non-royalty based on sub-licensee payments received                         25.00%             25.00%                      
Payment or accrual under the agreement                   0   0             0                        
Royalty payments                                                 0            
Annual minimum royalties due under agreement                                       10,000                      
Annual minimum royalties due when claim in the licensed patent rights issued in defined major market country                                       25,000                      
Period of notice required for termination of agreement                     90 days   3 months             60 days                      
Ownership interest (as a percent)                                       2.50%                      
Annual licensing fee through 2008                         30,000                                    
Annual licensing fee from 2009 through 2010                         60,000                                    
Annual licensing fee from 2011 through 2012                         62,000                                    
Annual licensing fee in 2013                         122,000                                    
Annual licensing fee thereafter                         120,000                                    
Payments upon execution of a sub license                         $ 35,000                                    
XML 21 R31.htm IDEA: XBRL DOCUMENT v2.4.0.8
COMMITMENTS (Details) (USD $)
3 Months Ended 118 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Mar. 31, 2014
Lease      
Rent expense $ 13,000 $ 13,000 $ 551,000
XML 22 R8.htm IDEA: XBRL DOCUMENT v2.4.0.8
ORGANIZATION, HISTORY AND NATURE OF OPERATIONS
3 Months Ended
Mar. 31, 2014
ORGANIZATION, HISTORY AND NATURE OF OPERATIONS  
ORGANIZATION, HISTORY AND NATURE OF OPERATIONS

NOTE A—ORGANIZATION, HISTORY AND NATURE OF OPERATIONS

 

NephroGenex, Inc. (the “Company”) was incorporated in Delaware on May 25, 2004. The Company is a drug development company focused on developing novel therapies for kidney disease. The Company acquired commercial rights to Pyridorin™ and has completed a Phase 2b clinical study in diabetic nephropathy patients.

 

The Company’s primary efforts to date have been devoted to raising capital, recruiting senior management and staff and conducting research and development activities. Accordingly, the Company is considered to be in the development stage. The Company has had limited capital resources and has experienced recurring net losses and negative cash flows from operations since inception. Operations have been financed to date by debt and equity financings as discussed in Notes D and E. On February 14, 2014, the Company closed its initial public offering of 3,100,000 shares of common stock at a price of $12.00 per share for total gross proceeds of $37.2 million, less underwriting discounts, commissions and offering expenses.

 

In addition to the normal risks associated with a new business venture, the Company currently has no commercially approved products and there can be no assurance that the Company’s research and development will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property.

XML 23 R32.htm IDEA: XBRL DOCUMENT v2.4.0.8
RELATED PARTY TRANSACTIONS (Details) (USD $)
0 Months Ended 3 Months Ended 118 Months Ended 3 Months Ended 12 Months Ended 118 Months Ended
Feb. 14, 2014
Mar. 31, 2014
Mar. 31, 2014
Mar. 31, 2014
Care
Mar. 31, 2013
Care
Dec. 31, 2007
Care
Mar. 31, 2014
Care
RELATED PARTY TRANSACTIONS              
Payments of Stock Issuance Costs $ 3,800,000 $ 3,731,763 $ 3,761,392     $ 80,000  
Expense for services provided       $ 50,000 $ 24,000   $ 714,000
XML 24 R2.htm IDEA: XBRL DOCUMENT v2.4.0.8
Balance Sheets (USD $)
Mar. 31, 2014
Dec. 31, 2013
Current assets    
Cash and cash equivalents $ 33,513,394 $ 2,131,990
Prepaid expenses and other assets 667,782 11,711
Total current assets 34,181,176 2,143,701
Property and equipment, net 13,989 10,826
Deferred initial public offering costs   461,079
Other assets 4,097 4,097
Total assets 34,199,262 2,619,703
Current liabilities    
Accounts payable 76,169 47,865
Accrued and other liabilities 707,587 1,858,061
Preferred stock warrant liability   6,982,640
Convertible notes payable   7,916,870
Total current liabilities 783,756 16,805,436
Stockholders' equity (deficiency)    
Common stock; $.001 par value; 100,000,000 shares authorized; 8,855,114 and 319,882 shares issued and outstanding as of March 31, 2014 and December 31, 2013, respectively 8,855 320
Additional paid-in capital 76,106,173 26,789,465
Deficit accumulated during the development stage (42,699,522) (40,999,206)
Total stockholders' equity (deficiency) 33,415,506 (14,185,733)
Total liabilities and stockholders' equity (deficiency) 34,199,262 2,619,703
Series A Preferred Stock
   
Stockholders' equity (deficiency)    
Preferred stock   23,688
Total stockholders' equity (deficiency)   23,688
Preferred stock
   
Stockholders' equity (deficiency)    
Preferred stock      
XML 25 R6.htm IDEA: XBRL DOCUMENT v2.4.0.8
Statement of Stockholders' Deficiency (Parenthetical) (USD $)
3 Months Ended 7 Months Ended
Mar. 31, 2014
Dec. 31, 2004
Statement of Stockholders' Equity (Deficiency)    
Sale of common stock for cash in May 2004 (in dollars per share)   $ 0.05
Issuance of common stock at IPO, expenses $ 3,767,348  
XML 26 R22.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCK OPTION PLAN (Tables)
3 Months Ended
Mar. 31, 2014
STOCK OPTION PLAN  
Summary of stock option activity

 

 

 

Number
of Shares

 

Weighted
Average
Exercise
Price

 

Exercisable
at March 31,
2014

 

Granted

 

2,489

 

$

32.50

 

1,260

 

Outstanding as of December 31, 2005

 

2,489

 

32.50

 

 

 

Granted

 

52,659

 

0.65

 

53,535

 

Exercised

 

 

 

 

 

Cancelled

 

 

 

 

 

Outstanding as of December 31, 2007

 

55,148

 

2.08

 

 

 

Granted

 

284,915

 

0.39

 

303,154

 

Exercised

 

 

 

 

 

Cancelled

 

(2,000

)

0.39

 

 

 

Outstanding as of December 31, 2008

 

338,063

 

0.65

 

 

 

Granted

 

114,500

 

1.95

 

390,949

 

Exercised

 

 

 

 

 

Cancelled

 

(18,965

)

0.98

 

 

 

Outstanding as of December 31, 2009

 

433,598

 

0.98

 

 

 

Granted

 

 

 

390,949

 

Exercised

 

(10,476

)

0.39

 

 

 

Cancelled

 

 

 

 

 

Outstanding as of December 31, 2010

 

423,122

 

0.98

 

 

 

Granted

 

90,305

 

1.82

 

448,152

 

Exercised

 

 

 

 

 

Cancelled

 

(1,538

)

0.39

 

 

 

Outstanding as of December 31, 2011

 

511,889

 

1.17

 

 

 

Granted

 

 

 

 

 

Exercised

 

 

 

 

 

Cancelled

 

(38,084

)

1.50

 

448,152

 

Outstanding as of December 31, 2012

 

473,805

 

1.11

 

 

 

Granted

 

91,261

 

2.02

 

 

 

Exercised

 

 

 

 

 

Cancelled

 

(1,613

)

32.50

 

 

 

Outstanding as of December 31, 2013

 

563,453

 

 

1.17

 

478,572

 

Granted

 

247,410

 

10.28

 

 

 

Exercised

 

 

 

 

 

Cancelled

 

 

 

 

 

Outstanding as of March 31, 2014

 

810,863

 

$

3.96

 

512,186

XML 27 R24.htm IDEA: XBRL DOCUMENT v2.4.0.8
SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $)
3 Months Ended 1 Months Ended 3 Months Ended
Mar. 31, 2014
item
Dec. 31, 2013
Mar. 31, 2013
Mar. 31, 2014
Options
Dec. 31, 2013
Options
Mar. 31, 2013
Options
Dec. 31, 2012
Options
Dec. 31, 2011
Options
Dec. 31, 2010
Options
Dec. 31, 2009
Options
Dec. 31, 2008
Options
Dec. 31, 2007
Options
Dec. 31, 2005
Options
Nov. 30, 2013
RSU
CEO
Mar. 31, 2014
RSU
CEO
SIGNIFICANT ACCOUNTING POLICIES                              
Deficit accumulated during the development stage $ (42,699,522) $ (40,999,206)                          
Number of operating segment 1                            
Income taxes:                              
Interest or penalties related to income taxes accrued or recognized $ 0   $ 0                        
Earnings per share                              
Shares issuable upon the exercise of options (in shares)       810,863 563,453 473,805 473,805 511,889 423,122 433,598 338,063 55,148 2,489    
Restricted Stock Units (RSU) issues (in shares)                           24,000 24,000
XML 28 Show.js IDEA: XBRL DOCUMENT /** * Rivet Software Inc. * * @copyright Copyright (c) 2006-2011 Rivet Software, Inc. All rights reserved. * Version 2.4.0.3 * */ var Show = {}; Show.LastAR = null, Show.hideAR = function(){ Show.LastAR.style.display = 'none'; }; Show.showAR = function ( link, id, win ){ if( Show.LastAR ){ Show.hideAR(); } var ref = link; do { ref = ref.nextSibling; } while (ref && ref.nodeName != 'TABLE'); if (!ref || ref.nodeName != 'TABLE') { var tmp = win ? win.document.getElementById(id) : document.getElementById(id); if( tmp ){ ref = tmp.cloneNode(true); ref.id = ''; link.parentNode.appendChild(ref); } } if( ref ){ ref.style.display = 'block'; Show.LastAR = ref; } }; Show.toggleNext = function( link ){ var ref = link; do{ ref = ref.nextSibling; }while( ref.nodeName != 'DIV' ); if( ref.style && ref.style.display && ref.style.display == 'none' ){ ref.style.display = 'block'; if( link.textContent ){ link.textContent = link.textContent.replace( '+', '-' ); }else{ link.innerText = link.innerText.replace( '+', '-' ); } }else{ ref.style.display = 'none'; if( link.textContent ){ link.textContent = link.textContent.replace( '-', '+' ); }else{ link.innerText = link.innerText.replace( '-', '+' ); } } }; XML 29 R7.htm IDEA: XBRL DOCUMENT v2.4.0.8
Statements of Cash Flows (USD $)
3 Months Ended 118 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Mar. 31, 2014
Operating activities      
Net loss $ (1,700,316) $ (473,824) $ (42,699,522)
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities      
Depreciation and amortization 753 3,143 106,932
Common stock issued in consideration for research and development     1,218,297
Change in fair value of preferred stock warrants 140,428   7,178,162
Non-cash interest expense 78,084   1,486,952
Stock based compensation expense 100,786 23,940 820,960
Changes in operating assets and liabilities      
Prepaid expenses and other assets (656,071) 6,442 (671,879)
Accounts payable, accrued and other liabilities (46,581) (50,499) 777,799
Net cash and cash equivalents used in operating activities (2,082,917) (490,798) (31,782,299)
Investing activities      
Property and equipment purchases (3,916)   (120,921)
Net cash and cash equivalents used in investing activities (3,916)   (120,921)
Financing activities      
Proceeds from issuance of notes payable     1,655,000
Payment of note payable     (100,000)
Proceeds from issuance of convertible notes payable   512,048 7,916,870
Payment of initial public offering costs (3,731,763)   (3,761,392)
Proceeds from issuance of common stock, Series A preferred stock and warrants 37,200,000   59,700,550
Proceeds from exercise of common stock options     5,586
Net cash and cash equivalents provided by financing activities 33,468,237 512,048 65,416,614
Net increase in cash and cash equivalents 31,381,404 21,250 33,513,394
Cash and cash equivalents at beginning of period 2,131,990 323,678  
Cash and cash equivalents at end of period 33,513,394 344,928 33,513,394
Supplemental disclosure of cash flow information      
Cash paid for interest     4,690
Supplemental disclosure of noncash financing activities      
Conversion of notes payable into Series A preferred stock and warrants     1,555,000
Conversion of accrued interest into Series A preferred stock and warrants     758,772
Increase in additional paid-in capital resulting from exercise of warrant     2,458,882
Initial public offering costs included in accrued and other liabilities 5,956   5,956
Conversion of convertible notes payable, accrued interest, preferred stock and warrants into common stock $ 15,791,805   $ 15,791,805
XML 30 R3.htm IDEA: XBRL DOCUMENT v2.4.0.8
Balance Sheets (Parenthetical) (USD $)
Mar. 31, 2014
Dec. 31, 2013
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, shares authorized 100,000,000 100,000,000
Common stock, shares issued 8,855,114 319,882
Common stock, shares outstanding 8,855,114 319,882
Series A Preferred Stock
   
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, shares authorized 32,690,676 32,690,676
Preferred stock, shares issued 0 23,688,396
Preferred stock, shares outstanding 0 23,688,396
Preferred stock
   
Preferred stock, par value (in dollars per share) $ 0.001  
Preferred stock, shares authorized 5,000,000  
Preferred stock, shares issued 0  
Preferred stock, shares outstanding 0  
XML 31 R17.htm IDEA: XBRL DOCUMENT v2.4.0.8
RELATED PARTY TRANSACTIONS
3 Months Ended
Mar. 31, 2014
RELATED PARTY TRANSACTIONS  
RELATED PARTY TRANSACTIONS

NOTE J—RELATED PARTY TRANSACTIONS

 

From time to time, the Company reimbursed Care Capital, LLC (“Care”), an affiliate of the majority shareholder of the Company, for certain expenses paid by Care on behalf of the Company. During 2007, the Company reimbursed Care approximately $80,000 for expenses incurred by Care in connection with the May 2007 Stock Purchase Agreement (Note E).

 

The Company uses the services of a Care employee and reimburses Care for such personnel services incurred by Care on behalf of the Company. For the three months ended March 31, 2014 and 2013 and the cumulative period from May 25, 2004 (inception) to March 31, 2014, the total expense recognized in operating results in connection with services provided by Care was $50,000, $24,000 and $714,000, respectively.

 

As discussed in Note G, the Company has entered into license and royalty agreements with certain shareholders of the Company.

XML 32 R1.htm IDEA: XBRL DOCUMENT v2.4.0.8
Document and Entity Information
3 Months Ended
Mar. 31, 2014
May 08, 2014
Document and Entity Information    
Entity Registrant Name NephroGenex, Inc.  
Entity Central Index Key 0001338095  
Document Type 10-Q  
Document Period End Date Mar. 31, 2014  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Current Reporting Status Yes  
Entity Filer Category Smaller Reporting Company  
Entity Common Stock, Shares Outstanding   8,555,114
Document Fiscal Year Focus 2014  
Document Fiscal Period Focus Q1  
XML 33 R18.htm IDEA: XBRL DOCUMENT v2.4.0.8
QUALIFIED THERAPEUTIC DISCOVERY PROGRAM AWARD
3 Months Ended
Mar. 31, 2014
QUALIFIED THERAPEUTIC DISCOVERY PROGRAM AWARD  
QUALIFIED THERAPEUTIC DISCOVERY PROGRAM AWARD

NOTE K—QUALIFIED THERAPEUTIC DISCOVERY PROGRAM AWARD

 

In 2010, the Company was awarded approximately $244,000 under the Federal government Qualifying Therapeutic Discovery Program (“QTDP”) initiative, all of which is included in other income in the accompanying statement of operations for the period from May 25, 2004 (inception) through March 31, 2014.

XML 34 R4.htm IDEA: XBRL DOCUMENT v2.4.0.8
Statements of Comprehensive Loss (USD $)
3 Months Ended 118 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Mar. 31, 2014
Expenses:      
Research and development $ 457,376 $ 264,560 $ 29,465,241
General and administrative 1,034,425 138,137 5,485,469
Total expenses 1,491,801 402,697 34,950,710
Loss from operations (1,491,801) (402,697) (34,950,710)
Other income (expense):      
Change in value of preferred stock warrants (140,428)   (7,178,162)
Interest expense (78,084) (71,303) (1,510,849)
Interest income 9,997 176 695,720
Qualifying Therapeutic Discovery Program grant     244,479
Net loss (1,700,316) (473,824) (42,699,522)
Net loss per share - basic and diluted (in dollars per share) $ (0.37) $ (1.48) $ (140.53)
Weighted average shares outstanding - basic and diluted (in shares) 4,587,498 319,882 303,856
Comprehensive loss $ (1,700,316) $ (473,824) $ (42,699,522)
XML 35 R12.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCKHOLDERS' EQUITY (DEFICIENCY)
3 Months Ended
Mar. 31, 2014
STOCKHOLDERS' EQUITY (DEFICIENCY)  
STOCKHOLDERS' EQUITY (DEFICIENCY)

NOTE E—STOCKHOLDERS’ EQUITY (DEFICIENCY)

 

Series A Preferred Stock

 

May 2007 Stock Purchase Agreement

 

On May 4, 2007, the Company entered into a Stock Purchase Agreement (the “Agreement”) with new and existing stockholders. The terms of the agreement provided for the initial issuance of approximately 4.8 million shares of Series A stock (the “First Close”) in exchange for cash of $1.5 million, conversion of the Notes, including accrued interest, of $2.3 million, and the acquisition of certain technology from BioStratum, Inc (“Bio”). The Agreement also provided for a second and third close (referred to individually as “Warrant 1” and “Warrant 2”, respectively, or collectively as “Warrants”) whereby certain investors in the First Close were given a right, but not the obligation, to purchase additional shares of Series A and common stock at defined prices. The value assigned to the acquired technology from Bio was approximately $1.1 million. Such amount was expensed as research and development expense at the time the First Close was completed since the acquired technology will be used in the Company’s research efforts and had no alternative future use. For financial reporting purposes, the First Close was accounted for as the issuance of 4.8 million shares of Series A stock and two warrants (Warrant 1 and 2) in consideration for cash, conversion of the Notes and acquired technology.

 

The table below summarizes the allocation of the consideration received to the financial instruments issued in the First Close.

 

Consideration received

 

 

 

Cash

 

$

1,500,000

 

Conversion of the Notes and accrued interest (See Note D)

 

2,313,772

 

Acquired technology

 

1,093,339

 

 

 

$

4,907,111

 

Allocation to financial instruments

 

 

 

Series A stock

 

$

2,503,323

 

Preferred stock warrant liability

 

2,403,788

 

 

 

$

4,907,111

 

 

Warrants

 

Warrant 1, as amended, provided the holder the right, but not the obligation, to purchase up to an additional 18 million shares of Series A stock and 45,234 shares of common stock in consideration for $20.0 million. Warrant 1 was exercised in part during December 2007 and fully exercised during March 2008. In connection with the partial exercise of Warrant 1 in December 2007, the Company issued approximately 1.8 million shares of Series A stock in exchange for $2.0 million. In March 2008, the holders of Warrant 1 exercised their remaining right to acquire 16 million shares of Series A stock and 45,234 common shares in consideration for approximately $18.0 million. As discussed below, the deemed fair value of Warrant 1 at the date of issuance through the date of exercise was accounted for as a preferred stock warrant liability.

 

Upon the partial exercise of Warrant 1 in December 2007, approximately $245,000 of the prorated share of the deemed fair value of Warrant 1 at the time of exercise attributable to the Series A stock issued was reclassified from the preferred stock warrant liability to additional paid-in capital and accounted for as additional consideration received in connection with the partial exercise of Warrant 1. In March 2008, the balance of the preferred stock warrant liability for Warrant 1, of approximately $2.2 million, was reclassified from preferred stock warrant liability to additional paid-in capital and accounted for as additional consideration received.

 

The fair value of the Warrants was estimated on the date of issuance using the Black-Scholes option pricing model. The Company accounted for the Warrants in accordance with the provisions of ASC-480 and other accounting standards. The Company recorded the fair value of the Warrants as a liability on its balance sheet until the Warrants expired or were exercised. The Warrants were revalued to their then estimated fair value, using the Black-Scholes model, at each reporting period end through December 31, 2012, and the Probability Weighted Expected Return Method calculated with the assistance of a third party valuation firm as of December 31, 2013, and any change in the fair value of the Warrants was reflected in operating results. The assumptions used in the Black-Scholes model to value the Warrants from their May 4, 2007 date of issuance through December 31, 2012 was a term ranging from 1 to 4 years, a risk free interest rate of approximately 0.185% to 3.36%, volatility of 60%, and the fair value of the Series A stock ranging from $1.11 to $1.39.

 

On January 16, 2014, an agreement was reached among the Company’s significant shareholders to cancel Warrant 2 held by its majority shareholder, Care Capital Investments III, LP, together with its affiliates (collectively, Care Capital), and by funds affiliated with Rho Venture Partners (Rho). Pursuant to this agreement, an aggregate of 593,589 shares of the Company’s common stock were issued to Care Capital and Rho concurrently with the completion of the Company’s initial public offering in return for cancelling Warrant 2. In connection with the issuance of the shares referenced above and the cancellation of Warrant 2, the Company settled the preferred stock warrant liability on its balance sheet on February 14, 2014.

 

The table below summarizes the changes in the fair value measurements of the Warrants, which used significant unobservable inputs (Level 3), from their issuance date (May 4, 2007) to March 31, 2014:

 

Warrants deemed fair value at issuance

 

$

2,403,788

 

Reclassification to additional paid-in capital upon partial Warrant 1 exercise

 

(245,402

)

Change in deemed fair value of the Warrants during 2007

 

4,463,509

 

Deemed fair value of warrants at December 31, 2007

 

6,621,895

 

Reclassification to additional paid-in capital upon remaining Warrant 1 exercise

 

(2,213,480

)

Change in deemed fair value of the Warrants during 2008

 

941,639

 

Deemed fair value of warrants at December 31, 2008

 

5,350,054

 

Change in deemed fair value of the Warrants during 2009

 

(950,641

)

Deemed fair value of warrants at December 31, 2009

 

4,399,413

 

Change in deemed fair value of the Warrants during 2010

 

 

Deemed fair value of warrants at December 31, 2010

 

4,399,413

 

Change in deemed fair value of the Warrants during 2011

 

(835,411

)

Deemed fair value of warrants at December 31, 2011

 

3,564,002

 

Change in deemed fair value of the Warrants during 2012

 

1,800

 

Deemed fair value of warrants at December 31, 2012

 

3,565,802

 

Change in deemed fair value of the Warrants during 2013

 

3,416,838

 

Deemed fair value of warrants at December 31, 2013

 

6,982,640

 

Change in deemed fair value of the Warrants during 2014

 

140,428

 

Settlement of warrant liability during 2014

 

(7,123,068

)

Deemed fair value of warrants at March 31, 2014

 

$

 

 

On February 10, 2014, the Company, in connection with the IPO, issued the underwriter warrants to purchase up to 62,000 shares of common stock. The warrants are exercisable at any time, in whole or in part, during the four-year period commencing one year from the effective date of the Company’s initial public offering. The warrants are exercisable at a price of $15.00 per share. The exercise price and number of shares issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend or the Company’s recapitalization, reorganization, merger or consolidation. However, the warrant exercise price or underlying shares will not be adjusted for issuances of shares of common stock at a price below the warrant exercise price.

 

Common Stock

 

On February 6, 2014, the Company effected a 1-for-6.5 reverse stock split of its issued and outstanding shares of common stock and a proportional adjustment to the conversion ratio for each series of Series A Preferred Stock. Accordingly, all share and per share amounts for all periods presented in these financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the reverse stock split and adjustment of the preferred share conversion ratios.

 

On February 14, 2014, the Company filed an Amended and Restated Certificate of Incorporation which authorizes the issuance of 100,000,000 shares of common stock, and 5,000,000 shares of undesignated preferred stock.

 

On February 14, 2014, the Company closed its initial public offering of 3,100,000 shares of common stock at a price of $12.00 per share for total gross proceeds of $37.2 million, less underwriting discounts, commissions and offering expenses of approximately $3.8 million. In connection with the completion of the offering, 3,644,354 shares of common stock were issued for the conversion of all outstanding shares of Series A Preferred stock, 1,197,289 shares of common stock were issued for the convertible notes and accrued interest and 593,589 aggregate shares of common stock were issued in connection with the settlement of Warrant 2.

XML 36 R11.htm IDEA: XBRL DOCUMENT v2.4.0.8
NOTES PAYABLE
3 Months Ended
Mar. 31, 2014
NOTES PAYABLE  
NOTES PAYABLE

NOTE D—NOTES PAYABLE

 

During the period from May 25, 2004 (inception) to December 31, 2006 certain stockholders lent the Company an aggregate of approximately $1.7 million. In connection therewith, the Company executed numerous agreements (“Notes”) that provided the lenders with various rights and preferences including interest at rates ranging from 7.75% to 11.25%, security interest in all the assets of the Company and conversion rights into preferred stock. Certain Notes issued in 2006 contained beneficial conversion features (“BCF”) whereby upon conversion of the convertible note into preferred stock, the holder received a favorable exchange rate that was accounted for as additional interest expense. The BCF totaled $560,000 and was recognized as additional interest expense amortized over the life of the Notes.

 

On May 4, 2007, all the Notes, and the related accrued and unpaid interest was converted into shares of Series A Preferred Stock (Note E).

 

During 2011, the Company sold convertible promissory notes for approximately $2,100,000 in aggregate to shareholders of the Company.

 

During 2012, the Company sold convertible promissory notes for approximately $1,255,000 in aggregate to shareholders of the Company.

 

During 2013, the Company sold convertible promissory notes for approximately $4,562,000 in aggregate to shareholders of the Company.

 

On February 14, 2014, in connection with the closing of the Company’s initial public offering, the convertible promissory notes and accrued interest were converted into 1,197,289 shares of common stock.

 

The Company had accrued interest of approximately $0 and $650,000 as of March 31, 2014 and December 31, 2013, respectively, which is included in accrued and other liabilities on the accompanying balance sheets. Interest expense relating to the notes was approximately $78,000 and $71,000 for the three months ended March 31, 2014 and 2013, respectively, and approximately $1.5 million for the period from May 25, 2004 (inception) to March 31, 2014.

XML 37 R23.htm IDEA: XBRL DOCUMENT v2.4.0.8
ORGANIZATION, HISTORY AND NATURE OF OPERATIONS (Details) (USD $)
In Millions, except Share data, unless otherwise specified
0 Months Ended
Feb. 14, 2014
ORGANIZATION, HISTORY AND NATURE OF OPERATIONS  
Number of shares issued 3,100,000
Common stock price (in dollars per share) $ 12.00
Total gross proceeds $ 37.2
XML 38 R19.htm IDEA: XBRL DOCUMENT v2.4.0.8
SIGNIFICANT ACCOUNTING POLICIES (Policies)
3 Months Ended
Mar. 31, 2014
SIGNIFICANT ACCOUNTING POLICIES  
Basis of presentation

Basis of presentation:

 

The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).

 

From its inception, the Company has devoted substantially all of its efforts to business planning, engaging regulatory, manufacturing and other technical consultants, acquiring operating assets, planning clinical trials and raising capital. The Company has experienced net losses since its inception and, as of March 31, 2014, had a deficit accumulated during the development stage of $42.7 million.

Use of estimates

Use of estimates:

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Segment reporting

   Segment reporting:

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment.

Cash and cash equivalents

  Cash and cash equivalents:

 

The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents.

Property and equipment

   Property and equipment:

 

Property and equipment consists of furniture, fixtures and computers. Property and equipment are carried at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the respective asset’s useful life. Maintenance and repairs that do not improve or extend the life of assets are expensed as incurred. When an asset is retired or disposed of, the cost and related accumulated depreciation are removed from the accounts and any resulting gains or losses are reflected within the statement of operations.

Fair value of financial instruments

   Fair value of financial instruments:

 

FASB ASC 820—Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. The estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments.

 

FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).

 

The three levels of the fair value hierarchy are as follows:

 

·                  Level 1—Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities.

 

·                  Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g. quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.

 

·                  Level 3—Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.

 

The carrying amounts reported in the balance sheet for cash and cash equivalents, accounts payable and accrued expenses approximate their fair value based on the short-term maturity of these instruments. The carrying amounts reported in the balance sheet for notes payable approximate their fair value based on market rates of interest and the terms of the notes. The Company recognizes all derivative financial instruments as assets or liabilities in the financial statements and measures them at fair value with changes in fair value reflected as current period income or loss unless the derivatives qualify as hedges. Certain terms of the May 4, 2007 Stock Purchase Agreement were accounted for as derivatives, which were valued under Level 3 of the fair value hierarchy. See Note E, Stockholders’ Equity (Deficit).

Research and development costs

Research and development costs:

 

Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities including non-cash share-based compensation, costs for third-party contractors to perform research, conduct clinical trials and prepare drug materials, research supplies and facilities costs. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered.

Income taxes

Income taxes:

 

The Company utilizes the liability method of accounting for income taxes as required by FASB ASC Topic 740 Income Taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Uncertain tax positions are evaluated in accordance with this topic and if appropriate, the amount of unrecognized tax benefits are recorded within deferred tax assets. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.

 

ASC Topic 740 also clarifies the accounting for uncertainty in income taxes recognized in the financial statements. The interpretation prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. There were no significant matters determined to be unrecognized tax benefits taken or expected to be taken in a tax return that have been recorded in the Company’s financial statements through March 31, 2014. ASC Topic 740 provides guidance on the recognition of interest and penalties related to income taxes. There were no interest or penalties related to income taxes that have been accrued or recognized as of March 31, 2014 or for the three months ended March 31, 2014 or 2013, or for the period from May 25, 2004 (inception) to March 31, 2014. The Company has elected to treat interest and penalties, to the extent they arise, as a component of income taxes. Tax years beginning in 2010 for federal purposes are generally subject to examination by taxing authorities, although net operating losses from all prior years are subject to examinations and adjustments for at least three years following the year in which the tax attributes are utilized.

Stock based compensation

    Stock based compensation:

 

The Company recognizes compensation cost relating to share-based payment transactions in net loss using a fair-value measurement method, in accordance with ASC-718 Compensation-Stock Compensation. ASC-718 requires all share based payments to employees, including grants of employee stock option, to be recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. The Company determines the fair value of share-based awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield, expected forfeiture rate and expected life of the options. The Company has also granted stock options to nonemployees. Grants to non-employees are accounted for in accordance with ASC-505-50 Equity—Based Payments to Non-Employees. The Company determines the fair value of share based awards granted to nonemployees similar to the way fair value of awards are determined for employees except that certain assumptions used in the Black-Scholes option-pricing model, such as expected life of the option, maybe different and the fair value of each award is adjusted at the end of each period for any change in fair value from the previous valuation until the award vests.

Earnings Per Share

      Earnings Per Share:

 

Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income (loss) available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there are a significant number of common stock options outstanding, fluctuations in the actual market price could have a variety of results for each period presented. No potentially dilutive equity instruments were included in the computations of diluted earnings per share for the three months ended March 31, 2014 or 2013 or for the period from May 25, 2004 (inception) to March 31, 2014 because their effect would be anti-dilutive as a result of losses incurred during those periods. Shares issuable upon the exercise of options outstanding at March 31, 2014 and 2013 were 810,863 and 473,805, respectively. As of March 31, 2014, the Company had also issued 24,000 Restricted Stock Units (RSU).

XML 39 R15.htm IDEA: XBRL DOCUMENT v2.4.0.8
RECENT ACCOUNTING PRONOUNCEMENTS
3 Months Ended
Mar. 31, 2014
RECENT ACCOUNTING PRONOUNCEMENTS  
RECENT ACCOUNTING PRONOUNCEMENTS

NOTE H—RECENT ACCOUNTING PRONOUNCEMENTS

 

Occasionally, new accounting standards are issued or proposed by the Financial Accounting Standards Board (the “FASB”), or other standards-setting bodies that the Company adopts by the effective date specified within the standard. Unless otherwise discussed, standards that do not require adoption until a future date are not expected to have a material impact on the Company’s financial statements upon adoption.

 

In February 2013, the FASB issued a final rule related to the reporting of amounts reclassified out of accumulated other comprehensive income that requires entities to report, either on their income statement or in a footnote to their financial statements, the effects on earnings from items that are reclassified out of other comprehensive income. The new accounting rule was effective for the Company in the first quarter of 2013. The adoption of the new accounting rule did not have a material effect on the Company’s financial condition, results of operations or cash flows. The Company chose to present the total of comprehensive income, the components of net income, and the components of other comprehensive income in a single continuous statement of operations and comprehensive income.

 

In July 2013, the FASB issued Accounting Standards Update, or ASU, No. 2013-11, Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists. ASU 2013-11 provides explicit guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. The guidance is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013, with an option for early adoption. The Company adopted this guidance on January 1, 2014. The adoption did not impact the Company’s financial position or results of operations.

XML 40 R13.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCK OPTION PLAN
3 Months Ended
Mar. 31, 2014
STOCK OPTION PLAN  
STOCK OPTION PLAN

NOTE F—STOCK OPTION PLAN

 

In 2005, the Company adopted the NephroGenex, Inc. 2005 Stock Option Plan (the “Plan”). The Plan, as amended, and subject to shareholder approval of an increase of 673,923 shares, provides for the granting of up to 1,283,226 shares of common stock to employees and consultants of the Company in the form of incentive and nonqualified stock options and shares of restricted stock. Options and restricted stock vest over various periods ranging from eight months to four years. All options expire ten years from grant date. Shares available for future grant at March 31, 2014 total 472,363. The table below summarizes stock option activity from the Plan’s inception through March 31, 2014.

 

 

 

Number
of Shares

 

Weighted
Average
Exercise
Price

 

Exercisable
at March 31,
2014

 

Granted

 

2,489

 

$

32.50

 

1,260

 

Outstanding as of December 31, 2005

 

2,489

 

32.50

 

 

 

Granted

 

52,659

 

0.65

 

53,535

 

Exercised

 

 

 

 

 

Cancelled

 

 

 

 

 

Outstanding as of December 31, 2007

 

55,148

 

2.08

 

 

 

Granted

 

284,915

 

0.39

 

303,154

 

Exercised

 

 

 

 

 

Cancelled

 

(2,000

)

0.39

 

 

 

Outstanding as of December 31, 2008

 

338,063

 

0.65

 

 

 

Granted

 

114,500

 

1.95

 

390,949

 

Exercised

 

 

 

 

 

Cancelled

 

(18,965

)

0.98

 

 

 

Outstanding as of December 31, 2009

 

433,598

 

0.98

 

 

 

Granted

 

 

 

390,949

 

Exercised

 

(10,476

)

0.39

 

 

 

Cancelled

 

 

 

 

 

Outstanding as of December 31, 2010

 

423,122

 

0.98

 

 

 

Granted

 

90,305

 

1.82

 

448,152

 

Exercised

 

 

 

 

 

Cancelled

 

(1,538

)

0.39

 

 

 

Outstanding as of December 31, 2011

 

511,889

 

1.17

 

 

 

Granted

 

 

 

 

 

Exercised

 

 

 

 

 

Cancelled

 

(38,084

)

1.50

 

448,152

 

Outstanding as of December 31, 2012

 

473,805

 

1.11

 

 

 

Granted

 

91,261

 

2.02

 

 

 

Exercised

 

 

 

 

 

Cancelled

 

(1,613

)

32.50

 

 

 

Outstanding as of December 31, 2013

 

563,453

 

 

1.17

 

478,572

 

Granted

 

247,410

 

10.28

 

 

 

Exercised

 

 

 

 

 

Cancelled

 

 

 

 

 

Outstanding as of March 31, 2014

 

810,863

 

$

3.96

 

512,186

 

 

As of March 31, 2014, there were 512,186 options exercisable with a weighted average exercise price of $1.60 and a weighted average remaining term of 4.9 years.

 

The Company determines the fair value of stock options using the Black-Scholes option pricing model. The assumptions used to value stock options from the Company’s inception to March 31, 2014, included expected terms ranging 4 to 10 years, risk free interest rate of approximately 2%, volatility of 60% to 80%, zero dividend yield and an estimated fair value of a share of common stock ranging from $0.39 to $12.00. Total unrecognized compensation costs related to unvested awards at March 31, 2014 was approximately $2.2 million and is expected to be recognized within future operating results over a weighted average period of approximately 4.0 years. Stock based compensation expense for the three months ended March 31, 2014 and 2013 was approximately $94,000 and $24,000, respectively. Stock based compensation expense for the period from May 25, 2004 (inception) to March 31, 2014 was approximately $810,000.

 

In November 2013, the Company issued 24,000 Restricted Stock Units (RSU) to its CEO in connection with his employment agreement. These RSUs were not issued under the Plan. The RSU represent the right to receive shares of common stock, subject to the terms and conditions of a restricted stock unit agreement and grant notice.

 

As of March 31, 2014, none of the RSU had vested. The fair value of the RSU was estimated to be approximately $109,000, on the date of grant, which is being recognized over the four year vesting period of the RSU. For the three months ended March 31, 2014 and for the period from May 25, 2004 (Inception) to March 31, 2014, the Company recognized approximately $6,800 and $11,000, respectively, of stock based compensation. Total unrecognized compensation costs related to the RSU at March 31, 2014 was approximately $98,000, which is expected to be recognized within future operating results over a period of approximately 3.5 years.

 

On February 14, 2014, the Company’s Board of Directors granted 247,410 stock options to employees and Directors of the Company subject to shareholder approval of an increase in shares eligible for issuance under the Plan.  For accounting purposes, the Company determined these options to have been granted due to the fact that the Company’s Board of Directors controls greater than a majority of the Company’s outstanding common shares.

XML 41 R14.htm IDEA: XBRL DOCUMENT v2.4.0.8
LICENSE AGREEMENTS
3 Months Ended
Mar. 31, 2014
LICENSE AGREEMENTS  
LICENSE AGREEMENTS

NOTE G—LICENSE AGREEMENTS

 

[1]                                 BioStratum, Inc.

 

On May 8, 2006, the Company entered into a licensing agreement with Bio Stratum Incorporated (“Bio”) for exclusive rights to use certain technology. The agreement was amended on September 13, 2006 (the “2006 Bio Agreement”) and was superseded on May 4, 2007 by the Termination, Assignment, Assumption and Participation Agreement (the “2007 Bio Agreement”). In consideration for obtaining the licensed technology in 2006, the 2006 Bio Agreement provided for the issuance of 12,708 shares of common stock as defined and the payment of an upfront licensing fee of $500,000. The licensing fee was expensed during 2006 as research and development as the licensed technology will be used in the Company’s research efforts and had no alternative future use. The fair value of the 12,708 shares of common stock issued to Bio totaled approximately $5,000. The 2006 Bio Agreement contained numerous other terms and conditions substantially all of which were superseded by the 2007 Bio Agreement. The 2007 Bio Agreement provided for the Company to issue approximately 1.8 million shares of Series A stock and to issue approximately 208,000 shares of common stock contingent on the exercise of Warrant 1 (Note E). The estimated fair value of the 1.8 million shares of Series A stock totaled approximately $1.1 million and was expensed upon issuance as research and development as the licensed technology will be used in the Company’s research efforts and had no alternative future use. As discussed in Note E, in March 2008, the balance of Warrant 1 was fully exercised and Bio received approximately 208,000 shares of common stock as additional consideration for the licensed technology. The estimated fair value of the shares of common stock issued totaled approximately $81,000 and was expensed in 2008 upon issuance as research and development expense as the licensed technology will be used in the Company’s research efforts and had no alternative future use.

 

The Company recognized no expense for the Bio Agreement for the three months ended March 31, 2014 and 2013 and $1.1 million for the period May 25, 2004 (inception) to March 31, 2014, respectively.

 

[2]                                 Vanderbilt University

 

During 2006, the Company entered into a licensing agreement with Vanderbilt University (“Vanderbilt”) for the rights to use certain technology. The agreement, as amended, requires the Company to make milestone payments totaling approximately $1.1 million based upon certain events as defined in the agreement. Should the Company successfully develop a product using the licensed technology, Vanderbilt will be due royalties based on net sales at a rate of 5%. The Company must also pay Vanderbilt 25% of non-royalty sub-licensee payments received from a sub-licensee. Certain milestones can be paid in stock or are creditable against future royalties due based on net sales. As of March 31, 2014, no milestone or royalty payments have been paid or accrued.

 

Annual minimum royalties due under the licensing agreement are $10,000 and will increase to $25,000 when a claim in the licensed patent rights is issued in a major market country, as defined. The licensing agreement expires when the underlying patents to the licensed technology expire. The Company may terminate the agreement upon 60 days written notice to Vanderbilt. In consideration for the license, the Company issued 462 shares of common stock and granted Vanderbilt the right to maintain their ownership interest at 2.5% (the “Right”) for the period to a private financing, as defined. The estimated value of the 462 shares of common stock and the Right totaled approximately $7,000, which was expensed as research and development as the licensed technology will be used in the Company’s research efforts and has no alternative future use. The licensing agreement was amended in 2007 and provided for the settlement of the Right in exchange for 17,257 shares of common stock. The amendment also obligated the Company to issue an additional 24,014 shares of common stock contingent on the exercise of Warrant 1.

 

As discussed in Note E, during March 2008, the balance of Warrant 1 was fully exercised, and accordingly, Vanderbilt received 24,014 shares of common stock as additional consideration for the licensed technology. The estimated fair value of the shares of common stock totaled approximately $9,000, which was expensed upon issuance as research and development as the licensed technology will be used in the Company’s research efforts and had no alternative future use. For all periods presented, expenses recognized in connection with Vanderbilt were not material.

 

[3]                                 Tryggvason Biotech AB:

 

During 2005, the Company entered into a licensing agreement with Tryggvason Biotech AB and Handelsbolaget Christer Betsholtz (collectively “Tryggvason”) for the exclusive commercial rights to use their proprietary glomerular profiling technology. The agreement included an upfront payment of $5,000 and a commitment to issue 151 shares of common stock. The licensing fee was expensed as research and development as the licensed technology will be used in the Company’s research efforts and has no alternative future use. The fair value of the 151 shares of common stock issued was insignificant at the time of issuance. Tryggvason will be due royalties based on 2% of net sales, as defined. No royalties have been paid or accrued through March 31, 2014. The licensing agreement expires upon the expiration of the underlying patents.

 

[4]                                 FibroStatin SL:

 

During 2005, the Company entered into a licensing agreement with FibroStatin SL, for exclusive commercial rights to their proprietary technology. The agreement included an upfront payment of $5,000 and a commitment to issue FibroStatin 153 shares of common stock. The licensing fee was expensed as research and development as the licensed technology will be used in the Company’s research efforts and has no alternative future use. The fair value of the 153 shares of common stock issued was insignificant at the time of issuance. This licensing agreement was terminated on April 12, 2007.

 

[5]                                 The University of Kansas Medical Center Research Institute, Inc.:

 

During 2007, Bio assigned their rights to certain technology licensed from the University of Kansas Medical Center Research Institute, Inc. (“KUMC”) to the Company. The license gives the Company worldwide royalty free rights to use certain technology. Upon the achievement of certain defined product development milestones, the Company would be obligated to make up to $225,000 of payments to KUMC. The term of the agreement expires on the expiration of the underlying KUMC patents or November 2018, whichever occurs last. The Company can terminate the agreement with 90 days notice. As of March 31, 2014, no milestones have been paid or accrued.

 

[6]                                 The University of South Carolina Research Foundation, Corp.:

 

During 2007, Bio assigned their rights to certain technology licensed from the University of South Carolina Research Foundation, Corp. (“USCRF”) to the Company. The license gives the Company worldwide rights to use certain technology. The agreement was amended in August 2013. The Company is obligated to pay an annual licensing fee of $30,000 through 2008, $60,000 from 2009 through 2010, $62,000 from 2011 through 2012, $122,000 in 2013 and $120,000 thereafter. Upon the achievement of certain defined product development milestones, the Company would be obligated to make up to $6.1 million of payments to USCRF. The Company will be obligated to pay USCRF a one-time fee of $35,000 upon execution of a sublicense and would pay to USCRF 25% of any non-royalty sublicense payments received from a sub-licensee. The term of the agreement expires on the expiration of the underlying USCRF patents. The Company can terminate the license at any time upon three months prior written notice to USCRF.  As of March 31, 2014, no development milestones have been paid or accrued nor does the Company expect to achieve any development milestones during the next few years.

XML 42 R16.htm IDEA: XBRL DOCUMENT v2.4.0.8
COMMITMENTS
3 Months Ended
Mar. 31, 2014
COMMITMENTS  
COMMITMENTS

NOTE I—COMMITMENTS

 

Lease

 

The Company’s operating lease agreement in Research Triangle Park, North Carolina expired in December 2013, and the Company is currently leasing the space on a month-to-month basis.

 

For the three months ended March 31, 2014 and 2013 and for the cumulative period from May 25, 2004 (inception) to March 31, 2014, rent expense was approximately $13,000, $13,000, and $551,000, respectively.

XML 43 R21.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCKHOLDERS' EQUITY (DEFICIENCY) (Tables)
3 Months Ended
Mar. 31, 2014
STOCKHOLDERS' EQUITY (DEFICIENCY)  
Summary of allocation of consideration received to financial instruments

 

 

Consideration received

 

 

 

Cash

 

$

1,500,000

 

Conversion of the Notes and accrued interest (See Note D)

 

2,313,772

 

Acquired technology

 

1,093,339

 

 

 

$

4,907,111

 

Allocation to financial instruments

 

 

 

Series A stock

 

$

2,503,323

 

Preferred stock warrant liability

 

2,403,788

 

 

 

$

4,907,111

 

Summary of the changes in the fair value measurements of the warrants

 

 

Warrants deemed fair value at issuance

 

$

2,403,788

 

Reclassification to additional paid-in capital upon partial Warrant 1 exercise

 

(245,402

)

Change in deemed fair value of the Warrants during 2007

 

4,463,509

 

Deemed fair value of warrants at December 31, 2007

 

6,621,895

 

Reclassification to additional paid-in capital upon remaining Warrant 1 exercise

 

(2,213,480

)

Change in deemed fair value of the Warrants during 2008

 

941,639

 

Deemed fair value of warrants at December 31, 2008

 

5,350,054

 

Change in deemed fair value of the Warrants during 2009

 

(950,641

)

Deemed fair value of warrants at December 31, 2009

 

4,399,413

 

Change in deemed fair value of the Warrants during 2010

 

 

Deemed fair value of warrants at December 31, 2010

 

4,399,413

 

Change in deemed fair value of the Warrants during 2011

 

(835,411

)

Deemed fair value of warrants at December 31, 2011

 

3,564,002

 

Change in deemed fair value of the Warrants during 2012

 

1,800

 

Deemed fair value of warrants at December 31, 2012

 

3,565,802

 

Change in deemed fair value of the Warrants during 2013

 

3,416,838

 

Deemed fair value of warrants at December 31, 2013

 

6,982,640

 

Change in deemed fair value of the Warrants during 2014

 

140,428

 

Settlement of warrant liability during 2014

 

(7,123,068

)

Deemed fair value of warrants at March 31, 2014

 

$

 

XML 44 R26.htm IDEA: XBRL DOCUMENT v2.4.0.8
NOTES PAYABLE (Details) (USD $)
3 Months Ended 118 Months Ended 18 Months Ended 0 Months Ended 12 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Mar. 31, 2014
Dec. 31, 2013
Dec. 31, 2006
Notes
Dec. 31, 2006
Notes
Minimum
Dec. 31, 2006
Notes
Maximum
Feb. 14, 2014
Promissory notes
Dec. 31, 2013
Promissory notes
Dec. 31, 2012
Promissory notes
Dec. 31, 2011
Promissory notes
NOTES PAYABLE                      
Amount lent by stockholders         $ 1,700,000            
Interest rate (as a percent)           7.75% 11.25%        
Amount of debt having beneficial conversion feature         560,000            
Proceeds from sale of convertible debt   512,048 7,916,870           4,562,000 1,255,000 2,100,000
Shares issued for conversion of debt               1,197,289      
Accrued interest 0   0 650,000              
Interest expenses $ 78,084 $ 71,303 $ 1,510,849                
XML 45 R5.htm IDEA: XBRL DOCUMENT v2.4.0.8
Statement of Stockholders' Equity (Deficiency) (USD $)
Total
USD ($)
BioStratum, Inc.
USD ($)
Vanderbilt University
USD ($)
Tryggvason Biotech AB
USD ($)
FibroStatin SL
USD ($)
Series A Convertible Preferred Stock
USD ($)
Common Stock
USD ($)
Common Stock
BioStratum, Inc.
USD ($)
Common Stock
Vanderbilt University
USD ($)
Common Stock
Tryggvason Biotech AB
Common Stock
FibroStatin SL
Additional Paid-In Capital
USD ($)
Additional Paid-In Capital
BioStratum, Inc.
USD ($)
Additional Paid-In Capital
Vanderbilt University
USD ($)
Additional Paid-In Capital
Tryggvason Biotech AB
USD ($)
Additional Paid-In Capital
FibroStatin SL
USD ($)
Accumulated During the Development Stage
USD ($)
Balance at May. 24, 2004                                  
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Sale of stock for cash $ 550           $ 2         $ 548          
Sale of stock for cash (in shares)             1,690                    
Net loss (129,923)                               (129,923)
Balance at Dec. 31, 2004 (129,373)           2         548         (129,923)
Balance (in shares) at Dec. 31, 2004             1,690                    
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Net loss (688,915)                               (688,915)
Balance at Dec. 31, 2005 (818,288)           2         548         (818,838)
Balance (in shares) at Dec. 31, 2005             1,690                    
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Issuance of shares (Note G)   4,961   60       13         4,948   60    
Issuance of shares (Note G) (in shares)               12,707   151              
Issuance of shares and warrant (Note G)     6,910                     6,910      
Issuance of shares and warrant (Note G) (in shares)                 461                
Net loss (1,337,715)                               (1,337,715)
Balance at Dec. 31, 2006 (2,144,072)           15         12,466         (2,156,553)
Balance (in shares) at Dec. 31, 2006             15,009                    
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Sale of stock for cash 2,245,402         1,800           2,243,602          
Sale of stock for cash (in shares)           1,800,456                      
Issuance of shares (Note G)         5,000                     5,000  
Issuance of shares (Note G) (in shares)                     153            
Issuance of stock for cash, licensed technology and the conversion of debt (Note E) 2,503,323         4,784           2,498,539          
Issuance of stock for cash, licensed technology and the conversion of debt (Note E) (in shares)           4,783,612                      
Exercise of warrant (Note G)                 17         (17)      
Exercise of warrant (Note G) (in shares)                 17,257                
Net loss (7,570,642)                               (7,570,642)
Balance at Dec. 31, 2007 (4,960,989)         6,584 32         4,759,590         (9,727,195)
Balance (in shares) at Dec. 31, 2007           6,584,068 32,419                    
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Sale of stock for cash 20,231,121         16,204 45         20,214,872          
Sale of stock for cash (in shares)           16,204,100 45,230                    
Issuance of shares (Note G)   81,021 9,365         208 24       80,813 9,341      
Issuance of shares (Note G) (in shares)               207,744 24,013                
Stock based compensation 115,347                     115,347          
Net loss (6,740,834)                               (6,740,834)
Balance at Dec. 31, 2008 8,735,031         22,788 309         25,179,963         (16,468,029)
Balance (in shares) at Dec. 31, 2008           22,788,168 309,406                    
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Stock based compensation 126,725                     126,725          
Net loss (7,549,788)                               (7,549,788)
Balance at Dec. 31, 2009 1,311,968         22,788 309         25,306,688         (24,017,817)
Balance (in shares) at Dec. 31, 2009           22,788,168 309,406                    
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Sale of stock for cash 1,000,000         900           999,100          
Sale of stock for cash (in shares)           900,228                      
Stock based compensation 139,209                     139,209          
Issuance of common stock upon exercise of stock options 5,586           11         5,575          
Issuance of common stock upon exercise of stock options (in shares)             10,476                    
Net loss (5,920,765)                               (5,920,765)
Balance at Dec. 31, 2010 (3,464,002)         23,688 320         26,450,572         (29,938,582)
Balance (in shares) at Dec. 31, 2010           23,688,396 319,882                    
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Stock based compensation 125,370                     125,370          
Net loss (1,851,797)                               (1,851,797)
Balance at Dec. 31, 2011 (5,190,429)         23,688 320         26,575,942         (31,790,379)
Balance (in shares) at Dec. 31, 2011           23,688,396 319,882                    
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Stock based compensation 125,506                     125,506          
Net loss (2,904,164)                               (2,904,164)
Balance at Dec. 31, 2012 (7,969,087)         23,688 320         26,701,448         (34,694,543)
Balance (in shares) at Dec. 31, 2012           23,688,396 319,882                    
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Stock based compensation 88,017                     88,017          
Net loss (6,304,663)                               (6,304,663)
Balance at Dec. 31, 2013 (14,185,733)         23,688 320         26,789,465         (40,999,206)
Balance (in shares) at Dec. 31, 2013           23,688,396 319,882                    
Increase (Decrease) in Stockholders' Equity [Roll Forward]                                  
Issuance of common stock at IPO, net of expenses of $3,767,348 (unaudited) 33,432,652           3,100         33,429,552          
Issuance of common stock at IPO, net of expenses of $3,767,348 (unaudited) (in shares)             3,100,000                    
Issuance of common stock for preferred stock warrant (unaudited) 7,123,068           594         7,122,474          
Issuance of common stock for preferred stock warrant (unaudited) (in shares)             593,589                    
Issuance of common stock for convertible notes and accrued interest (unaudited) 8,645,049           1,197         8,643,852          
Issuance of common stock for convertible notes and accrued interest (unaudited) (in shares)             1,197,289                    
Issuance of common stock for preferred stock (unaudited)           (23,688) 3,644         20,044          
Issuance of common stock for preferred stock (unaudited) (in shares)           (23,688,396) 3,644,354                    
Stock based compensation 100,786                     100,786          
Net loss (1,700,316)                               (1,700,316)
Balance at Mar. 31, 2014 $ 33,415,506           $ 8,855         $ 76,106,173         $ (42,699,522)
Balance (in shares) at Mar. 31, 2014             8,855,114                    
XML 46 R10.htm IDEA: XBRL DOCUMENT v2.4.0.8
PROPERTY AND EQUIPMENT
3 Months Ended
Mar. 31, 2014
PROPERTY AND EQUIPMENT  
PROPERTY AND EQUIPMENT

NOTE C—PROPERTY AND EQUIPMENT

 

Property and equipment as of March 31, 2014 and December 31, 2013 consisted of:

 

 

 

Useful Life

 

2014

 

2013

 

Computer equipment

 

3 years

 

$

54,646

 

$

50,730

 

Furniture and fixtures

 

7 years

 

66,275

 

66,275

 

 

 

 

 

120,921

 

117,005

 

Less accumulated depreciation

 

 

 

(106,932

)

(106,179

)

Property and equipment, net

 

 

 

$

13,989

 

$

10,826

 

 

For the three months ended March 31, 2014 and 2013 depreciation expense was approximately $750 and $3,100, respectively. Depreciation expense for the period from May 25, 2004 (inception) to March 31, 2014 was approximately $106,900.

XML 47 R27.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCKHOLDERS' EQUITY (DEFICIENCY) (Details) (USD $)
3 Months Ended 7 Months Ended 12 Months Ended 3 Months Ended 7 Months Ended 12 Months Ended 68 Months Ended 0 Months Ended 1 Months Ended 1 Months Ended 1 Months Ended
Mar. 31, 2014
Dec. 31, 2004
Dec. 31, 2010
Dec. 31, 2008
Dec. 31, 2007
Dec. 31, 2010
Series A Convertible Preferred Stock
Dec. 31, 2008
Series A Convertible Preferred Stock
Dec. 31, 2007
Series A Convertible Preferred Stock
Mar. 31, 2014
Common Stock
Dec. 31, 2004
Common Stock
Dec. 31, 2008
Common Stock
Dec. 31, 2012
Warrants
Dec. 31, 2012
Warrants
Minimum
Dec. 31, 2012
Warrants
Maximum
May 04, 2007
First Close
item
May 04, 2007
First Close
Preferred stock warrant liability
May 04, 2007
First Close
Series A Convertible Preferred Stock
Mar. 31, 2008
Warrant 1
May 04, 2007
Warrant 1
Mar. 31, 2008
Warrant 1
Series A Convertible Preferred Stock
Dec. 31, 2007
Warrant 1
Series A Convertible Preferred Stock
May 04, 2007
Warrant 1
Series A Convertible Preferred Stock
Mar. 31, 2008
Warrant 1
Common Stock
May 04, 2007
Warrant 1
Common Stock
Stock issued (in shares)               4,783,612                 4,800,000              
Number of warrants                             2                  
Cash   $ 550 $ 1,000,000 $ 20,231,121 $ 2,245,402 $ 900 $ 16,204 $ 1,800   $ 2 $ 45       $ 1,500,000     $ 18,000,000     $ 2,000,000      
Number of shares of stock issued           900,228 16,204,100 1,800,456   1,690 45,230                 16,000,000 1,800,000   45,234  
Conversion of the Notes and accrued interest 8,645,049               1,197           2,313,772                  
Acquired technology                             1,093,339                  
Total         2,503,323     4,784             4,907,111 2,403,788 2,503,323              
Number of shares of stock to be acquired                                           18,000,000   45,234
Aggregate exercise price                                     $ 20,000,000          
Exercise price (in dollars per share)                         $ 1.11 $ 1.39                    
Assumptions used to calculate fair value of the warrants                                                
Term of warrants                         1 year 4 years                    
Risk free interest rate (as a percent)                         0.185% 3.36%                    
Volatility (as a percent)                       60.00%                        
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PROPERTY AND EQUIPMENT (Tables)
3 Months Ended
Mar. 31, 2014
PROPERTY AND EQUIPMENT  
Schedule of property and equipment

 

 

 

 

Useful Life

 

2014

 

2013

 

Computer equipment

 

3 years

 

$

54,646

 

$

50,730

 

Furniture and fixtures

 

7 years

 

66,275

 

66,275

 

 

 

 

 

120,921

 

117,005

 

Less accumulated depreciation

 

 

 

(106,932

)

(106,179

)

Property and equipment, net

 

 

 

$

13,989

 

$

10,826