10-Q 1 crnx-10q_20190630.htm 10-Q crnx-10q_20190630.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)





 

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

 

For the quarterly period ended June 30, 2019



 

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: 001-38583

Crinetics Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

26-3744114

(State or other jurisdiction

of incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

10222 Barnes Canyon Road, Bldg. #2,

San Diego, California

 

92121

(Address of principal executive offices)

 

(Zip code)

 

Registrant’s telephone number, including area code: (858) 450-6464

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

CRNX

 

Nasdaq Global Select Market

 

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

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

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

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

 

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

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

As of July 31, 2019, the registrant had 24,199,972 shares of common stock ($0.001 per share par value) outstanding.

 

 

 

 


CRINETICS PHARMACEUTICALS, INC.

QUARTERLY REPORT ON FORM 10-Q

For the Quarter Ended June 30, 2019

TABLE OF CONTENTS

 

 

 

 

Page

 

PART I – FINANCIAL INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Condensed Consolidated Financial Statements:

 

3

 

 

Condensed Consolidated Balance Sheets as of June 30, 2019 (unaudited) and December 31, 2018

 

3

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2019 and 2018 (unaudited)

 

4

 

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the three and six months ended June 30, 2019 and 2018 (unaudited)

 

5

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2019 and 2018 (unaudited)

 

6

 

 

Notes to Condensed Consolidated Financial Statements (unaudited)

 

7

Item 2.

 

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

 

18

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

25

Item 4.

 

Controls and Procedures  

 

25

 

 

 

 

 

PART II — OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings  

 

26

Item 1A.

 

Risk Factors  

 

26

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

26

Item 3.

 

Defaults Upon Senior Securities

 

26

Item 4.

 

Mine Safety Disclosures

 

26

Item 5.

 

Other Information

 

26

Item 6.

 

Exhibits

 

28

 

 

 

2


PART I — FINANCIAL INFORMATION

Item 1.

Condensed Financial Statements

Crinetics Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2019

 

 

2018

 

 

 

(Unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

59,716

 

 

$

44,973

 

Investment securities

 

 

85,258

 

 

 

118,902

 

Prepaid expenses and other current assets

 

 

2,784

 

 

 

2,808

 

Total current assets

 

 

147,758

 

 

 

166,683

 

Property and equipment, net

 

 

4,264

 

 

 

4,232

 

Operating lease right-of-use asset

 

 

2,627

 

 

 

 

Restricted cash

 

 

500

 

 

 

500

 

Total assets

 

$

155,149

 

 

$

171,415

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,705

 

 

$

1,456

 

Accrued expenses and other current liabilities

 

 

3,243

 

 

 

4,190

 

Accrued compensation and benefits

 

 

1,802

 

 

 

2,279

 

Total current liabilities

 

 

7,750

 

 

 

7,925

 

Non-current operating lease liability

 

 

5,226

 

 

 

 

Deferred rent

 

 

 

 

 

3,063

 

Unvested stock liability

 

 

72

 

 

 

202

 

Total liabilities

 

 

13,048

 

 

 

11,190

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par, 10,000 shares authorized; no shares issued

    or outstanding at June 30, 2019 or at December 31, 2018

 

 

 

 

 

 

Common stock and paid-in capital, $0.001 par, 200,000 shares authorized;

    24,245 and 24,195 shares issued and outstanding at June 30, 2019;

    24,188 and 24,061 shares issued and outstanding at December 31, 2018

 

 

206,690

 

 

 

203,544

 

Accumulated other comprehensive income

 

 

234

 

 

 

61

 

Accumulated deficit

 

 

(64,823

)

 

 

(43,380

)

Total stockholders’ equity

 

 

142,101

 

 

 

160,225

 

Total liabilities and stockholders’ equity

 

$

155,149

 

 

$

171,415

 

 

See the accompanying notes to these unaudited condensed consolidated financial statements.

 

3


Crinetics Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except per share data)

(Unaudited)

 

 

 

Three months ended June 30,

 

 

Six months ended June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Grant revenues

 

$

 

 

$

657

 

 

$

367

 

 

$

1,099

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

10,285

 

 

 

5,222

 

 

 

17,540

 

 

 

9,942

 

General and administrative

 

 

3,060

 

 

 

1,118

 

 

 

6,216

 

 

 

2,366

 

Total operating expenses

 

 

13,345

 

 

 

6,340

 

 

 

23,756

 

 

 

12,308

 

Loss from operations

 

 

(13,345

)

 

 

(5,683

)

 

 

(23,389

)

 

 

(11,209

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

960

 

 

 

151

 

 

 

1,970

 

 

 

215

 

Other income (expense)

 

 

(42

)

 

 

(36

)

 

 

(24

)

 

 

(38

)

Total other income (expense), net

 

 

918

 

 

 

115

 

 

 

1,946

 

 

 

177

 

Net loss

 

 

(12,427

)

 

 

(5,568

)

 

 

(21,443

)

 

 

(11,032

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on investment securities

 

 

89

 

 

 

 

 

 

173

 

 

 

 

Comprehensive loss

 

$

(12,338

)

 

$

(5,568

)

 

$

(21,270

)

 

$

(11,032

)

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share – basic and diluted

 

$

(0.51

)

 

$

(2.41

)

 

$

(0.89

)

 

$

(5.28

)

Weighted-average shares outstanding – basic and diluted

 

 

24,161

 

 

 

2,307

 

 

 

24,128

 

 

 

2,089

 

 

See the accompanying notes to these unaudited condensed consolidated financial statements.

 

4


Crinetics Pharmaceuticals, Inc.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(In thousands, except per share data)

(Unaudited)

 

 

 

Convertible

Preferred Stock

 

 

Common Stock

 

 

Common stock

and Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Capital

 

 

Income

 

 

Deficit

 

 

Equity (Deficit)

 

Balance at April 1, 2018

 

 

48,404

 

 

$

92,975

 

 

 

2,191

 

 

$

1,753

 

 

$

 

 

$

(21,729

)

 

$

(19,976

)

Vesting of stock subject to repurchase

 

 

 

 

 

 

 

 

3

 

 

 

5

 

 

 

 

 

 

 

 

 

5

 

Exercise of stock options

 

 

 

 

 

 

 

 

150

 

 

 

91

 

 

 

 

 

 

 

 

 

91

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

271

 

 

 

 

 

 

 

 

 

271

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,568

)

 

 

(5,568

)

Balance at June 30, 2018

 

 

48,404

 

 

$

92,975

 

 

 

2,344

 

 

$

2,120

 

 

$

 

 

$

(27,297

)

 

$

(25,177

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at January 1, 2018

 

 

28,763

 

 

$

29,700

 

 

 

1,550

 

 

$

1,243

 

 

$

 

 

$

(16,265

)

 

$

(15,022

)

Issuance of Series B convertible preferred stock

 

 

19,641

 

 

 

63,275

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of founders shares and stock subject

   to repurchase

 

 

 

 

 

 

 

 

529

 

 

 

8

 

 

 

 

 

 

 

 

 

8

 

Exercise of stock options

 

 

 

 

 

 

 

 

265

 

 

 

171

 

 

 

 

 

 

 

 

 

171

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

698

 

 

 

 

 

 

 

 

 

698

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,032

)

 

 

(11,032

)

Balance at June 30, 2018

 

 

48,404

 

 

$

92,975

 

 

 

2,344

 

 

$

2,120

 

 

$

 

 

$

(27,297

)

 

$

(25,177

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at April 1, 2019

 

 

 

 

$

 

 

 

24,115

 

 

$

204,645

 

 

$

145

 

 

$

(52,396

)

 

$

152,394

 

Vesting of stock subject to repurchase

 

 

 

 

 

 

 

 

13

 

 

 

18

 

 

 

 

 

 

 

 

 

18

 

Exercise of stock options

 

 

 

 

 

 

 

 

42

 

 

 

67

 

 

 

 

 

 

 

 

 

67

 

Issuance of stock under Stock Purchase Plan

 

 

 

 

 

 

 

 

25

 

 

 

379

 

 

 

 

 

 

 

 

 

379

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

1,581

 

 

 

 

 

 

 

 

 

1,581

 

Comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

89

 

 

 

 

 

 

89

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,427

)

 

 

(12,427

)

Balance at June 30, 2019

 

 

 

 

$

 

 

 

24,195

 

 

$

206,690

 

 

$

234

 

 

$

(64,823

)

 

$

142,101

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at January 1, 2019

 

 

 

 

$

 

 

 

24,061

 

 

$

203,544

 

 

$

61

 

 

$

(43,380

)

 

$

160,225

 

Vesting of shares of stock subject to repurchase

 

 

 

 

 

 

 

 

46

 

 

 

71

 

 

 

 

 

 

 

 

 

71

 

Exercise of stock options

 

 

 

 

 

 

 

 

63

 

 

 

87

 

 

 

 

 

 

 

 

 

87

 

Issuance of stock under Stock Purchase Plan

 

 

 

 

 

 

 

 

25

 

 

 

379

 

 

 

 

 

 

 

 

 

379

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

2,609

 

 

 

 

 

 

 

 

 

2,609

 

Comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

173

 

 

 

 

 

 

173

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,443

)

 

 

(21,443

)

Balance at June 30, 2019

 

 

 

 

$

 

 

 

24,195

 

 

$

206,690

 

 

$

234

 

 

$

(64,823

)

 

$

142,101

 

 

See the accompanying notes to these unaudited condensed consolidated financial statements.

 

5


Crinetics Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Six months ended

 

 

 

June 30,

 

 

 

2019

 

 

2018

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(21,443

)

 

$

(11,032

)

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

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

2,609

 

 

 

698

 

Depreciation and amortization

 

 

430

 

 

 

124

 

Noncash lease expense

 

 

109

 

 

 

 

Accretion of investment securities and purchase discounts, net of

   amortization of purchase premiums

 

 

(689

)

 

 

 

Other

 

 

2

 

 

 

76

 

Increase (decrease) in cash resulting from changes in:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

24

 

 

 

(1,275

)

Accounts payable and accrued expenses

 

 

(92

)

 

 

3,652

 

Operating lease liability

 

 

(277

)

 

 

 

Net cash used in operating activities

 

 

(19,327

)

 

 

(7,757

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of investment securities

 

 

(52,664

)

 

 

 

Maturities of investment securities

 

 

87,170

 

 

 

 

Purchases of property and equipment

 

 

(464

)

 

 

(526

)

Net cash provided by (used in) investing activities

 

 

34,042

 

 

 

(526

)

Financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of convertible preferred stock, net

 

 

 

 

 

63,266

 

Proceeds from exercise of stock options

 

 

87

 

 

 

393

 

Repurchase of unvested shares

 

 

(59

)

 

 

 

Payment of initial public offering costs

 

 

 

 

 

(660

)

Net cash provided by financing activities

 

 

28

 

 

 

62,999

 

Net change in cash, cash equivalents and restricted cash

 

 

14,743

 

 

 

54,716

 

Cash, cash equivalents and restricted cash at beginning of period

 

 

45,473

 

 

 

14,192

 

Cash, cash equivalents and restricted cash at end of period

 

$

60,216

 

 

$

68,908

 

Noncash investing and financing activities:

 

 

 

 

 

 

 

 

Purchase of shares pursuant to Employee Stock Purchase Plan

 

$

379

 

 

$

 

Change in unvested stock liability

 

$

(71

)

 

$

(7

)

Amounts accrued for purchases of property and equipment

 

$

 

 

$

52

 

Tenant improvement allowance

 

$

 

 

$

954

 

Accrued but unpaid preferred stock issuance and initial public offering costs

 

$

 

 

$

1,046

 

 

See the accompanying notes to these unaudited condensed consolidated financial statements.

 

6


Crinetics Pharmaceuticals, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

1. ORGANIZATION AND BASIS OF PRESENTATION

Description of Business

Crinetics Pharmaceuticals, Inc. (the “Company”) is a clinical stage pharmaceutical company incorporated in Delaware on November 18, 2008 and based in San Diego, California. The Company is focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. In January 2017, the Company established a wholly owned Australian subsidiary, Crinetics Australia Pty Ltd (“CAPL”), in order to conduct various preclinical and clinical activities for its development candidates.

On July 6, 2018, the Company effected a 1-for-3.29 reverse stock split of its common stock. The par value and the authorized shares of the common stock were not adjusted as a result of the reverse stock split. The reverse stock split resulted in an adjustment to the conversion prices of the Company’s Series A and B preferred stock to reflect a proportional decrease in the number of shares of common stock to be issued upon conversion. The accompanying condensed consolidated financial statements and notes to the condensed consolidated financial statements give retroactive effect to the reverse stock split for all periods presented.

Unaudited Interim Financial Information

The accompanying interim condensed consolidated balance sheet as of June 30, 2019, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2019 and 2018, the condensed consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the three and six months ended June 30, 2019 and 2018, and the condensed consolidated statements of cash flows for the six months ended June 30, 2019 and 2018, and the related disclosures are unaudited. In management’s opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2019 and the results of its operations and cash flows for the six months ended June 30, 2019 and 2018 in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The results for the three and six months ended June 30, 2019 are not necessarily indicative of the results expected for the full fiscal year or any other interim period.

Principles of Consolidation and Foreign Currency Transactions

The condensed consolidated financial statements include the accounts of the Company and CAPL. All intercompany accounts and transactions have been eliminated in consolidation. The functional currency of both the Company and CAPL is the U.S. dollar. Assets and liabilities that are not denominated in the functional currency are remeasured into U.S. dollars at foreign currency exchange rates in effect at the balance sheet date except for nonmonetary assets, which are remeasured at historical foreign currency exchange rates in effect at the date of transaction. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in other income (expense), in the condensed consolidated statements of operations and were not material for all periods presented.

Segment Reporting

Operating segments are identified as components of an enterprise about which 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.

Liquidity and Going Concern

From inception, the Company has devoted substantially all of its efforts to drug discovery and development and conducting preclinical studies and clinical trials. The Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure.

7


As of June 30, 2019, the Company had $145.0 million in unrestricted cash, cash equivalents and investment securities. The Company believes it has sufficient cash to meet its funding requirements for at least the next 12 months. However, the Company has experienced net losses and negative cash flows from operating activities since its inception and has an accumulated deficit of $64.8 million as of June 30, 2019. The Company expects to continue to incur net losses for the foreseeable future and believes it will need to raise substantial additional capital to accomplish its business plan over the next several years. The Company plans to continue to fund its losses from operations and capital funding needs through a combination of equity offerings, debt financings or other sources, including potential collaborations, licenses and other similar arrangements. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations and future prospects. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

The Company’s condensed consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of the Company’s condensed consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. The most significant estimates in the Company’s condensed consolidated financial statements relate to revenue recognition, accrued amounts receivable under the Australian research and development tax incentive program, accrued expenses and associated research and development expense, the assumptions underlying the determination of the estimated incremental borrowing rate for the determination of the operating lease right-of-use asset, and the assumptions underlying the determination of the fair value of equity awards for purposes of determining stock-based compensation. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.

Fair Value Measurements

The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

Level 1: Observable inputs such as quoted prices in active markets.

Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly.

Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.

The carrying amounts of the Company’s current financial assets, restricted cash and current financial liabilities are considered to be representative of their respective fair values because of the short-term nature of those instruments.

8


Cash, Cash Equivalents and Restricted Cash

The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Cash and cash equivalents include cash in readily available checking and money market accounts. Restricted cash represents cash held as collateral for the Company’s facility lease and is reported as a long-term asset in the accompanying condensed consolidated balance sheets.

 

Investment Securities

All investments have been classified as “available-for-sale” and are carried at fair value as determined based upon quoted market prices or pricing models for similar securities at period end. Investments with contractual maturities less than 12 months at the balance sheet date are considered short-term investments. Investments with contractual maturities beyond one year are also classified as short-term due to the Company’s ability to liquidate the investment for use in operations within the next 12 months.

Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of securities sold. The Company has not realized any significant gains or losses on sales of available-for-sale investment securities during any of the periods presented. Unrealized gains and losses that are determined to be temporary in nature are reported as a component of accumulated other comprehensive income (loss). A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the establishment of a new cost basis for the security. Interest income is recognized when earned and includes the amortization of purchase premiums and accretion of purchase discounts.

Concentrations of Credit Risk

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial position of the depository institution in which those deposits are held. Additionally, the Company has established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity.

Leases

The Company determines if an arrangement is a lease at the inception of the arrangement. Leases with a term longer than 12 months that are determined to be operating leases are included in operating lease assets, accrued expenses and other current liabilities and noncurrent operating lease liabilities in the condensed consolidated balance sheets based on the present value of the minimum lease payments called for under the arrangement. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.

Grant Revenue Recognition

The Company’s grant revenues are derived from Small Business Innovation Research (“SBIR”) grants from the National Institutes of Health. The Company recognizes SBIR grant revenue as reimbursable grant costs are incurred. The costs associated with these reimbursements are reflected as a component of research and development expense in the accompanying condensed consolidated statements of operations. Earnings in excess of billings are included as a component of prepaid expenses and other current assets.

Research and Development Expenses

Research and development (“R&D”) expenses consist primarily of salaries, payroll taxes, employee benefits and stock-based compensation charges for those individuals involved in R&D efforts, as well as consulting expenses, third-party R&D expenses, laboratory supplies, clinical materials and overhead, including facilities and depreciation costs, offset by the Australian Tax Incentive discussed below. R&D expenses are charged to expense as incurred. Payments made prior to the receipt of goods or services to be used in R&D are capitalized until the goods or services are received.

9


Costs incurred under contracts with contract research organizations (CROs) that conduct and manage the Company’s clinical trials are also included in research and development expenses. The financial terms and activities of these agreements vary from contract to contract and may result in uneven expense levels. Generally, these agreements set forth activities that drive the recording of expenses such as start-up and initiation activities, enrollment and treatment of patients, or the completion of other clinical trial activities. Expenses related to clinical trials are accrued based on estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. If the amounts that the Company is obligated to pay under its clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), the Company adjusts its accruals accordingly on a prospective basis. Revisions to contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain.

Australian Research and Development Tax Incentive

CAPL is eligible to obtain a cash refund from the Australian Taxation Office for eligible R&D expenditures under the Australian Research and Development Tax Incentive Program (the “Australian Tax Incentive”). The Australian Tax Incentive is recognized as a reduction to R&D expense when there is reasonable assurance that the Australian Tax Incentive will be received, the relevant expenditure has been incurred, and the amount can be reliably measured. The Company recognized a reduction to R&D expense of $0.2 million and $0.6 million for the three months ended June 30, 2019 and 2018, respectively, and a reduction to R&D expense of $0.3 million and $0.9 million for the six months ended June 30, 2019 and 2018, respectively.

Stock-Based Compensation

Stock-based compensation expense represents the cost of the grant date fair value of awards over the requisite service period of the awards (usually the vesting period) on a straight-line basis. For stock awards for which vesting is subject to performance-based milestones, the expense is recorded over the remaining service period after the point when the achievement of the milestone is probable, or the performance condition has been achieved. The Company estimates the fair value of all stock option grants using the Black-Scholes option pricing model and recognizes forfeitures as they occur.

Comprehensive Loss

Comprehensive loss is comprised of the Company’s net loss for all periods presented and the unrealized gain on investment securities held as of June 30, 2019.

Net Loss Per Share

Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. Dilutive common stock equivalents are comprised of convertible preferred stock, common stock subject to repurchase, and options outstanding under the Company’s stock option plan. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.

Recently Adopted Accounting Pronouncements

ASU 2016-02

In February 2016, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2016-02, “Leases (Topic 842)” (“ASU 2016-02”) which requires lessees to recognize leases on the balance sheet and disclose key information about leasing arrangements. ASU 2016-02 establishes a right-of-use (ROU) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. ASU 2016-02 also requires disclosures to meet the objective of enabling users of financial statements to assess the amount, timing, and uncertainty of cash flows arising from leases. On January 1, 2019, the Company adopted ASU 2016-02 using the modified retrospective transition method. Under this transition method, the Company recognized and measured leases that existed at the adoption date in the condensed consolidated balance sheet as of January 1, 2019.

10


ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and operating lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term, discounted at the rate implicit in the lease. If the rate implicit in the lease cannot be determined, Topic 842 requires the use of the rate of interest that a lessee would have to pay to borrow on a collateralized basis over a similar term for a similar amount to the lease payments in a similar economic environment. The operating lease ROU asset is also adjusted for any prepaid or accrued lease payments and any lease incentives received. Operating lease terms may include options to extend or terminate the lease when it is reasonably certain that these options will be exercised. Further, the Company has elected to recognize short-term lease payments on a straight-line basis over the associated lease term and variable lease payments in the period in which the obligation for those payments is incurred. Short-term and variable lease payments were not material in the first half of 2019.

In connection with the adoption of ASU 2016-02, the Company elected the package of practical expedients requiring no reassessment of whether any expired or existing contracts contain leases, the lease classification of any expired or existing leases, or initial direct costs for any existing leases. The Company also made accounting policy elections not to apply the recognition requirements under ASU 2016-02 to any short-term leases and to account for each separate lease and associated non-lease components as a single lease component for all of the Company’s leases.

Adoption of ASU 2016-02 resulted in recognition of a ROU asset of $2.8 million and an operating lease liability of $6.2 million, related to the lease of office and laboratory space; and the derecognition of deferred rent of $3.4 million for certain lease incentives received previously. The comparative prior period information continues to be reported under the accounting standards in effect during those periods.

ASU 2018-07

In June 2018, the FASB issued ASU 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting” (“ASU 2018-07”), which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees and applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. ASU 2018-07 was adopted by the Company on January 1, 2019 using the modified retrospective transition method with no impact on the condensed consolidated financial statements. As a result of adopting ASU 2018-07, the estimated fair values of stock awards issued to non-employees are determined at issuance and are no longer subject to revaluation over their vesting terms.  

Recent Accounting Pronouncements

ASU 2018-13

In August 2018, the FASB issued ASU 2018-13, “Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement,” which improves the effectiveness of the disclosures required under ASC 820, “Fair Value Measurements and Disclosures” and modifies the disclosure requirements on fair value measurements, including the consideration of costs and benefits. The new standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, and early adoption is permitted. The Company is currently evaluating the impact of the pending adoption of this new standard on its consolidated financial statements.

11


3. INVESTMENT SECURITIES

The Company reports its available-for-sale investment securities at their estimated fair values based on quoted market prices for identical or similar instruments. The following is a summary of the available-for-sale investment securities held by the Company as of June 30, 2019 and December 31, 2018 (in thousands):

 

 

 

As of June 30, 2019

 

 

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair

Market

Value

 

Available-for-sale investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government and agency obligations

 

$

41,410

 

 

$

163

 

 

$

 

 

$

41,573

 

Certificates of deposit

 

 

5,909

 

 

 

52

 

 

 

 

 

 

5,961

 

Commercial paper

 

 

24,603

 

 

 

 

 

 

 

 

 

24,603

 

Corporate debt securities

 

 

13,102

 

 

 

19

 

 

 

 

 

 

13,121

 

Total

 

$

85,024

 

 

$

234

 

 

$

 

 

$

85,258

 

 

 

 

As of December 31, 2018

 

 

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair

Market

Value

 

Available-for-sale investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government and agency obligations

 

$

42,193

 

 

$

72

 

 

$

(1

)

 

$

42,264

 

Certificates of deposit

 

 

5,408

 

 

 

 

 

 

 

 

 

5,408

 

Commercial paper

 

 

47,686

 

 

 

 

 

 

 

 

 

47,686

 

Corporate debt securities

 

 

23,554

 

 

 

2

 

 

 

(12

)

 

 

23,544

 

Total

 

$

118,841

 

 

$

74

 

 

$

(13

)

 

$

118,902

 

 

All available-for-sale investment securities held at June 30, 2019 and December 31, 2018, had maturity dates of less than 24 months.

None of the Company’s available-for-sale investment securities were in a material unrealized loss position at June 30, 2019 or December 31, 2018. As such, the Company has not recognized any impairment in its financial statements related to its available-for-sale investment securities.

4. FAIR VALUE MEASUREMENTS

The Company holds investment securities that consist of highly liquid, investment grade debt securities. The Company determines the fair value of its investment securities based upon one or more valuations reported by its investment accounting and reporting service provider. The investment service provider values the securities using a hierarchical security pricing model that relies primarily on valuations provided by an industry-recognized valuation service. Such valuations may be based on trade prices in active markets for identical assets or liabilities (Level 1 inputs) or valuation models using inputs that are observable either directly or indirectly (Level 2 inputs), such as quoted prices for similar assets or liabilities, yield curves, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments or debt, and broker and dealer quotes, as well as other relevant economic measures.

Financial assets measured at fair value on a recurring basis as of June 30, 2019 and December 31, 2018 were as follows (in thousands):

 

 

 

As of June 30, 2019

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government and agency obligations

 

$

23,405

 

 

$

18,168

 

 

$

 

 

$

41,573

 

Certificates of deposit

 

 

 

 

 

5,961

 

 

 

 

 

 

5,961

 

Commercial paper

 

 

 

 

 

24,603

 

 

 

 

 

 

24,603

 

Corporate debt securities

 

 

 

 

 

13,121

 

 

 

 

 

 

13,121

 

Total assets measured at fair value

 

$

23,405

 

 

$

61,853

 

 

$

 

 

$

85,258

 

12


 

 

 

As of December 31, 2018

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government and agency obligations

 

$

22,275

 

 

$

19,989

 

 

$

 

 

$

42,264

 

Certificates of deposit

 

 

 

 

 

5,408

 

 

 

 

 

 

5,408

 

Commercial paper

 

 

 

 

 

47,686

 

 

 

 

 

 

47,686

 

Corporate debt securities

 

 

 

 

 

23,544