false Q2 CYMABAY THERAPEUTICS, INC. 0001042074 --12-31 Large Accelerated Filer 943103561 373000 us-gaap:OtherAccruedLiabilitiesCurrent us-gaap:OperatingLeaseLiabilityNoncurrent 2018-09-30 373000 0001042074 2019-01-01 2019-06-30 xbrli:shares 0001042074 2019-07-31 iso4217:USD 0001042074 2019-06-30 0001042074 2018-12-31 iso4217:USD xbrli:shares 0001042074 2019-04-01 2019-06-30 0001042074 2018-04-01 2018-06-30 0001042074 2018-01-01 2018-06-30 0001042074 2017-12-31 0001042074 2018-06-30 0001042074 us-gaap:CommonStockMember 2018-12-31 0001042074 us-gaap:AdditionalPaidInCapitalMember 2018-12-31 0001042074 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-12-31 0001042074 us-gaap:RetainedEarningsMember 2018-12-31 0001042074 us-gaap:CommonStockMember 2019-01-01 2019-03-31 0001042074 us-gaap:AdditionalPaidInCapitalMember 2019-01-01 2019-03-31 0001042074 2019-01-01 2019-03-31 0001042074 us-gaap:RetainedEarningsMember 2019-01-01 2019-03-31 0001042074 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-01-01 2019-03-31 0001042074 us-gaap:CommonStockMember 2019-03-31 0001042074 us-gaap:AdditionalPaidInCapitalMember 2019-03-31 0001042074 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-03-31 0001042074 us-gaap:RetainedEarningsMember 2019-03-31 0001042074 2019-03-31 0001042074 us-gaap:CommonStockMember 2019-04-01 2019-06-30 0001042074 us-gaap:AdditionalPaidInCapitalMember 2019-04-01 2019-06-30 0001042074 us-gaap:RetainedEarningsMember 2019-04-01 2019-06-30 0001042074 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-04-01 2019-06-30 0001042074 us-gaap:CommonStockMember 2019-06-30 0001042074 us-gaap:AdditionalPaidInCapitalMember 2019-06-30 0001042074 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-06-30 0001042074 us-gaap:RetainedEarningsMember 2019-06-30 0001042074 us-gaap:CommonStockMember 2017-12-31 0001042074 us-gaap:AdditionalPaidInCapitalMember 2017-12-31 0001042074 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2017-12-31 0001042074 us-gaap:RetainedEarningsMember 2017-12-31 0001042074 us-gaap:CommonStockMember 2018-01-01 2018-03-31 0001042074 us-gaap:AdditionalPaidInCapitalMember 2018-01-01 2018-03-31 0001042074 2018-01-01 2018-03-31 0001042074 us-gaap:RetainedEarningsMember 2018-01-01 2018-03-31 0001042074 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-01-01 2018-03-31 0001042074 us-gaap:CommonStockMember 2018-03-31 0001042074 us-gaap:AdditionalPaidInCapitalMember 2018-03-31 0001042074 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-03-31 0001042074 us-gaap:RetainedEarningsMember 2018-03-31 0001042074 2018-03-31 0001042074 us-gaap:CommonStockMember 2018-04-01 2018-06-30 0001042074 us-gaap:AdditionalPaidInCapitalMember 2018-04-01 2018-06-30 0001042074 us-gaap:RetainedEarningsMember 2018-04-01 2018-06-30 0001042074 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-04-01 2018-06-30 0001042074 us-gaap:CommonStockMember 2018-06-30 0001042074 us-gaap:AdditionalPaidInCapitalMember 2018-06-30 0001042074 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-06-30 0001042074 us-gaap:RetainedEarningsMember 2018-06-30 cbay:Segment cbay:ClinicalTrial 0001042074 us-gaap:CashEquivalentsMember us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member 2019-06-30 0001042074 us-gaap:CashEquivalentsMember us-gaap:MoneyMarketFundsMember 2019-06-30 0001042074 us-gaap:CashEquivalentsMember us-gaap:FairValueInputsLevel1Member 2019-06-30 0001042074 us-gaap:CashEquivalentsMember 2019-06-30 0001042074 cbay:MarketableSecuritiesMember us-gaap:CommercialPaperMember us-gaap:FairValueInputsLevel2Member 2019-06-30 0001042074 cbay:MarketableSecuritiesMember us-gaap:CommercialPaperMember 2019-06-30 0001042074 cbay:MarketableSecuritiesMember us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member 2019-06-30 0001042074 cbay:MarketableSecuritiesMember us-gaap:CorporateDebtSecuritiesMember 2019-06-30 0001042074 cbay:MarketableSecuritiesMember us-gaap:AssetBackedSecuritiesMember us-gaap:FairValueInputsLevel2Member 2019-06-30 0001042074 cbay:MarketableSecuritiesMember us-gaap:AssetBackedSecuritiesMember 2019-06-30 0001042074 cbay:MarketableSecuritiesMember us-gaap:USTreasurySecuritiesMember us-gaap:FairValueInputsLevel2Member 2019-06-30 0001042074 cbay:MarketableSecuritiesMember us-gaap:USTreasurySecuritiesMember 2019-06-30 0001042074 cbay:MarketableSecuritiesMember us-gaap:FairValueInputsLevel2Member 2019-06-30 0001042074 cbay:MarketableSecuritiesMember 2019-06-30 0001042074 us-gaap:FairValueInputsLevel1Member 2019-06-30 0001042074 us-gaap:FairValueInputsLevel2Member 2019-06-30 0001042074 us-gaap:FairValueInputsLevel1Member us-gaap:CashEquivalentsMember us-gaap:MoneyMarketFundsMember 2018-12-31 0001042074 us-gaap:CashEquivalentsMember us-gaap:MoneyMarketFundsMember 2018-12-31 0001042074 us-gaap:FairValueInputsLevel2Member us-gaap:CashEquivalentsMember us-gaap:CommercialPaperMember 2018-12-31 0001042074 us-gaap:CashEquivalentsMember us-gaap:CommercialPaperMember 2018-12-31 0001042074 us-gaap:FairValueInputsLevel1Member us-gaap:CashEquivalentsMember 2018-12-31 0001042074 us-gaap:FairValueInputsLevel2Member us-gaap:CashEquivalentsMember 2018-12-31 0001042074 us-gaap:CashEquivalentsMember 2018-12-31 0001042074 us-gaap:FairValueInputsLevel2Member cbay:MarketableSecuritiesMember us-gaap:CommercialPaperMember 2018-12-31 0001042074 cbay:MarketableSecuritiesMember us-gaap:CommercialPaperMember 2018-12-31 0001042074 us-gaap:FairValueInputsLevel2Member cbay:MarketableSecuritiesMember us-gaap:CorporateDebtSecuritiesMember 2018-12-31 0001042074 cbay:MarketableSecuritiesMember us-gaap:CorporateDebtSecuritiesMember 2018-12-31 0001042074 us-gaap:FairValueInputsLevel2Member cbay:MarketableSecuritiesMember us-gaap:AssetBackedSecuritiesMember 2018-12-31 0001042074 cbay:MarketableSecuritiesMember us-gaap:AssetBackedSecuritiesMember 2018-12-31 0001042074 us-gaap:FairValueInputsLevel2Member cbay:MarketableSecuritiesMember us-gaap:USTreasurySecuritiesMember 2018-12-31 0001042074 cbay:MarketableSecuritiesMember us-gaap:USTreasurySecuritiesMember 2018-12-31 0001042074 us-gaap:FairValueInputsLevel2Member cbay:MarketableSecuritiesMember 2018-12-31 0001042074 cbay:MarketableSecuritiesMember 2018-12-31 0001042074 us-gaap:FairValueInputsLevel1Member 2018-12-31 0001042074 us-gaap:FairValueInputsLevel2Member 2018-12-31 0001042074 us-gaap:FairValueInputsLevel3Member 2017-12-31 0001042074 us-gaap:FairValueInputsLevel3Member 2018-01-01 2018-06-30 0001042074 us-gaap:FairValueInputsLevel3Member 2018-06-30 0001042074 srt:MaximumMember 2019-01-01 2019-06-30 0001042074 srt:MinimumMember 2019-01-01 2019-06-30 0001042074 us-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember 2019-06-30 0001042074 us-gaap:CorporateDebtSecuritiesMember 2019-06-30 0001042074 us-gaap:AssetBackedSecuritiesMember 2019-06-30 0001042074 us-gaap:USTreasurySecuritiesMember 2019-06-30 0001042074 us-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember 2018-12-31 0001042074 us-gaap:CorporateDebtSecuritiesMember 2018-12-31 0001042074 us-gaap:AssetBackedSecuritiesMember 2018-12-31 0001042074 us-gaap:USTreasurySecuritiesMember 2018-12-31 cbay:Facility 0001042074 cbay:EmployeeOrNonEmployeeStockOptionsMember 2019-04-01 2019-06-30 0001042074 cbay:EmployeeOrNonEmployeeStockOptionsMember 2018-04-01 2018-06-30 0001042074 cbay:EmployeeOrNonEmployeeStockOptionsMember 2019-01-01 2019-06-30 0001042074 cbay:EmployeeOrNonEmployeeStockOptionsMember 2018-01-01 2018-06-30 0001042074 cbay:IncentiveStockAwardsMember 2019-04-01 2019-06-30 0001042074 cbay:IncentiveStockAwardsMember 2018-04-01 2018-06-30 0001042074 cbay:IncentiveStockAwardsMember 2019-01-01 2019-06-30 0001042074 cbay:IncentiveStockAwardsMember 2018-01-01 2018-06-30 0001042074 cbay:CommonStockWarrantMember 2018-04-01 2018-06-30 0001042074 cbay:CommonStockWarrantMember 2018-01-01 2018-06-30 0001042074 cbay:AccountingStandardsUpdateTwoThousandEighteenElevenMember 2019-01-01 0001042074 cbay:AccountingStandardsUpdateTwoThousandEighteenElevenMember 2019-01-01 2019-01-01 xbrli:pure 0001042074 srt:MaximumMember cbay:JanssenPharmaceuticalNVMember 2006-06-01 2006-06-30 0001042074 cbay:JanssenPharmaceuticalNVMember 2019-04-01 2019-06-30 0001042074 cbay:JanssenPharmaceuticalNVMember 2019-01-01 2019-06-30 0001042074 cbay:JanssenPharmaceuticalNVMember 2018-04-01 2018-06-30 0001042074 cbay:JanssenPharmaceuticalNVMember 2018-01-01 2018-06-30 0001042074 cbay:JanssenPharmaceuticalNVMember 2019-06-30 0001042074 cbay:JanssenPharmaceuticalNVMember 2018-06-30 cbay:Agreement 0001042074 cbay:JanssenPharmaceuticalsIncMember 2010-06-01 2010-06-30 0001042074 cbay:DiatexIncMember 2019-04-01 2019-06-30 0001042074 cbay:DiatexIncMember 2019-01-01 2019-06-30 0001042074 cbay:DiatexIncMember 2018-04-01 2018-06-30 0001042074 cbay:DiatexIncMember 2018-01-01 2018-06-30 0001042074 cbay:LeaseFacilityMember 2019-06-30 utr:sqft 0001042074 cbay:LeaseFacilityMember 2019-01-01 2019-06-30 0001042074 us-gaap:OperatingExpenseMember 2019-04-01 2019-06-30 0001042074 us-gaap:OperatingExpenseMember 2019-01-01 2019-06-30 0001042074 2018-02-01 0001042074 2018-02-01 2018-02-01 0001042074 2019-03-08 0001042074 2019-03-11 0001042074 2019-03-07 2019-03-08 0001042074 cbay:EquityIncentivePlanTwoThousandAndThirteenMember 2019-01-01 2019-01-01 0001042074 cbay:EquityIncentivePlanTwoThousandAndThirteenMember cbay:EmployeesDirectorsAndConsultantMember 2019-04-01 2019-06-30 0001042074 cbay:EquityIncentivePlanTwoThousandAndThirteenMember cbay:EmployeesDirectorsAndConsultantMember 2019-01-01 2019-06-30 0001042074 cbay:EquityIncentivePlanTwoThousandAndThirteenMember 2019-06-30 0001042074 us-gaap:ResearchAndDevelopmentExpenseMember 2019-04-01 2019-06-30 0001042074 us-gaap:ResearchAndDevelopmentExpenseMember 2018-04-01 2018-06-30 0001042074 us-gaap:ResearchAndDevelopmentExpenseMember 2019-01-01 2019-06-30 0001042074 us-gaap:ResearchAndDevelopmentExpenseMember 2018-01-01 2018-06-30 0001042074 us-gaap:GeneralAndAdministrativeExpenseMember 2019-04-01 2019-06-30 0001042074 us-gaap:GeneralAndAdministrativeExpenseMember 2018-04-01 2018-06-30 0001042074 us-gaap:GeneralAndAdministrativeExpenseMember 2019-01-01 2019-06-30 0001042074 us-gaap:GeneralAndAdministrativeExpenseMember 2018-01-01 2018-06-30

 

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

OR

 

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

 

FOR THE TRANSITION PERIOD FROM                      TO                     

Commission File Number 001-36500

 

CymaBay Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

94-3103561

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

7575 Gateway Blvd, Suite 110

NewarkCA

 

94560

(Address of principal executive offices)

 

(Zip Code)

 

(510) 293-8800

(Registrant’s telephone number, including area code)

 

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, $0.0001 par value per share

CBAY

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 the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

Smaller reporting company

 

 

 

 

 

 

 

 

Emerging growth company

 

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

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

As of July 31, 2019, there were 68,701,043 shares of the registrant’s Common Stock outstanding.

 

 

 


 

CYMABAY THERAPEUTICS, INC.

QUARTERLY REPORT ON FORM 10-Q

TABLE OF CONTENTS

 

 

 

 

 

Page

PART I

 

FINANCIAL INFORMATION

 

3

Item 1.

 

Financial Statements

 

3

 

 

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

 

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

 

5

 

 

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

 

6

 

 

Notes to Condensed Consolidated Financial Statements (unaudited)

 

8

Item 2.

 

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

 

19

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

25

Item 4.

 

Controls and Procedures

 

25

 

 

 

 

 

PART II

 

OTHER INFORMATION

 

26

Item 1A.

 

Risk Factors

 

26

Item 6.

 

Exhibits

 

49

 

 

 

 

 

Signatures

 

50

 

 

 

 

2


 

PART I. FINANCIAL INFORMATION

Item 1.

Financial Statements

CymaBay Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(unaudited)

 

 

 

June 30,

 

 

December 31,

 

 

 

2019

 

 

2018

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

28,081

 

 

$

48,995

 

Marketable securities

 

 

213,126

 

 

 

129,669

 

Accrued interest receivable

 

 

725

 

 

 

304

 

Prepaid expenses

 

 

7,881

 

 

 

2,594

 

Total current assets

 

 

249,813

 

 

 

181,562

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

2,693

 

 

 

2,905

 

Operating lease right-of-use asset

 

 

199

 

 

 

-

 

Other assets

 

 

730

 

 

 

2,280

 

Total assets

 

$

253,435

 

 

$

186,747

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,882

 

 

$

1,973

 

Accrued clinical trial expenses

 

 

9,274

 

 

 

8,588

 

Other accrued liabilities

 

 

3,266

 

 

 

3,854

 

Total current liabilities

 

 

15,422

 

 

 

14,415

 

Long-term portion of operating lease liability

 

 

1,954

 

 

 

-

 

Other liabilities

 

 

-

 

 

 

1,914

 

Total liabilities

 

 

17,376

 

 

 

16,329

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value: 10,000,000 shares authorized; no shares

   issued and outstanding

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value: 100,000,000 shares authorized; 68,701,043

   and 59,456,493 shares issued and outstanding as of June 30, 2019 and

   December 31, 2018, respectively

 

 

7

 

 

 

6

 

Additional paid-in capital

 

 

806,001

 

 

 

693,534

 

Accumulated other comprehensive income (loss)

 

 

228

 

 

 

(58

)

Accumulated deficit

 

 

(570,177

)

 

 

(523,064

)

Total stockholders’ equity

 

 

236,059

 

 

 

170,418

 

Total liabilities and stockholders’ equity

 

$

253,435

 

 

$

186,747

 

 

See accompanying notes to the condensed consolidated financial statements.

3


 

CymaBay Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share information)

(unaudited)

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

21,119

 

 

$

14,397

 

 

$

39,707

 

 

$

23,874

 

General and administrative

 

 

4,529

 

 

 

3,574

 

 

 

10,192

 

 

 

6,947

 

Total operating expenses

 

 

25,648

 

 

 

17,971

 

 

 

49,899

 

 

 

30,821

 

Loss from operations

 

 

(25,648

)

 

 

(17,971

)

 

 

(49,899

)

 

 

(30,821

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

1,610

 

 

 

1,061

 

 

 

2,786

 

 

 

1,769

 

Interest expense

 

 

-

 

 

 

(128

)

 

 

-

 

 

 

(336

)

Loss on extinguishment of debt

 

 

-

 

 

 

(407

)

 

 

-

 

 

 

(407

)

Other expense, net

 

 

-

 

 

 

(86

)

 

 

-

 

 

 

(4,741

)

Total other income (expense)

 

 

1,610

 

 

 

440

 

 

 

2,786

 

 

 

(3,715

)

Net loss

 

$

(24,038

)

 

$

(17,531

)

 

$

(47,113

)

 

$

(34,536

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

183

 

 

 

65

 

 

 

286

 

 

 

(23

)

Total other comprehensive income (loss)

 

 

183

 

 

 

65

 

 

 

286

 

 

 

(23

)

Comprehensive loss

 

$

(23,855

)

 

$

(17,466

)

 

$

(46,827

)

 

$

(34,559

)

Basic net loss per common share

 

$

(0.35

)

 

$

(0.30

)

 

$

(0.72

)

 

$

(0.61

)

Diluted net loss per common share

 

$

(0.35

)

 

$

(0.30

)

 

$

(0.72

)

 

$

(0.61

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding used to

   calculate basic net loss per common share

 

 

68,697,735

 

 

 

58,833,647

 

 

 

65,312,988

 

 

 

56,307,236

 

Weighted average common shares outstanding used to

   calculate diluted net loss per common share

 

 

68,697,735

 

 

 

58,905,898

 

 

 

65,312,988

 

 

 

56,307,236

 

 

See accompanying notes to the condensed consolidated financial statements.

4


 

CymaBay Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited)

 

 

 

Six Months Ended

 

 

 

June 30,

 

 

 

2019

 

 

2018

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(47,113

)

 

$

(34,536

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

278

 

 

 

25

 

Stock-based compensation expense

 

 

4,618

 

 

 

3,547

 

Net accretion and amortization of investments in marketable securities

 

 

(1,324

)

 

 

(777

)

Non-cash interest associated with debt discount accretion

 

 

-

 

 

 

148

 

Loss on extinguishment of debt

 

 

-

 

 

 

407

 

Change in fair value of warrant liability

 

 

-

 

 

 

4,741

 

Accretion of tenant improvement allowance

 

 

-

 

 

 

(61

)

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Receivable from collaboration

 

 

-

 

 

 

5,000

 

Interest receivable and other current assets

 

 

(421

)

 

 

(279

)

Prepaid expenses

 

 

(5,287

)

 

 

(923

)

Other assets

 

 

1,550

 

 

 

(729

)

Accounts payable

 

 

909

 

 

 

25

 

Accrued liabilities

 

 

142

 

 

 

4,191

 

Accrued interest payable

 

 

-

 

 

 

(43

)

Net cash used in operating activities

 

 

(46,648

)

 

 

(19,264

)

Investing activities

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(269

)

 

 

(46

)

Purchases of marketable securities

 

 

(221,278

)

 

 

(185,925

)

Proceeds from maturities of marketable securities

 

 

135,451

 

 

 

93,482

 

Proceeds from sale of marketable securities

 

 

3,980

 

 

 

-

 

Net cash used in investing activities

 

 

(82,116

)

 

 

(92,489

)

Financing activities

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

107,746

 

 

 

135,520

 

Proceeds from issuance of common stock pursuant to equity award plans

 

 

104

 

 

 

3,521

 

Proceeds from issuance of common stock upon exercise of warrants

 

 

-

 

 

 

1,037

 

Repayment of facility loan principal

 

 

-

 

 

 

(6,527

)

Payment of fees to extinguish facility loan

 

 

-

 

 

 

(126

)

Net cash provided by financing activities

 

 

107,850

 

 

 

133,425

 

Net (decrease) increase in cash and cash equivalents

 

 

(20,914

)

 

 

21,672

 

Cash and cash equivalents at beginning of period

 

 

48,995

 

 

 

23,054

 

Cash and cash equivalents at end of period

 

$

28,081

 

 

$

44,726

 

Supplemental disclosure

 

 

 

 

 

 

 

 

Cash paid for amounts included in the measurement of lease liabilities

 

$

313

 

 

$

-

 

Cash paid for interest

 

$

-

 

 

$

231

 

Supplemental non-cash investing and financing activities

 

 

 

 

 

 

 

 

Lessor funded lease incentives included in other current assets

 

$

-

 

 

$

2,100

 

Issuance of common stock upon warrant exercises

 

$

-

 

 

$

5,200

 

 

See accompanying notes to the condensed consolidated financial statements.

5


 

CymaBay Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share information)

(unaudited)

 

 

 

Three and Six Months Ended June 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balances as of December 31, 2018

 

 

59,456,493

 

 

$

6

 

 

$

693,534

 

 

$

(58

)

 

$

(523,064

)

 

$

170,418

 

Issuance of common stock upon

   exercise of stock options

   and incentive awards

 

 

37,550

 

 

 

-

 

 

 

97

 

 

 

-

 

 

 

-

 

 

 

97

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

2,342

 

 

 

-

 

 

 

-

 

 

 

2,342

 

Issuance of common stock, net of

   $7,254 issuance costs

 

 

9,200,000

 

 

 

1

 

 

 

107,745

 

 

 

-

 

 

 

-

 

 

 

107,746

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(23,075

)

 

 

(23,075

)

Net unrealized gain on marketable

   securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

103

 

 

 

-

 

 

 

103

 

Balances as of March 31, 2019

 

 

68,694,043

 

 

$

7

 

 

$

803,718

 

 

$

45

 

 

$

(546,139

)

 

$

257,631

 

Issuance of common stock upon

   exercise of stock options

   and incentive awards

 

 

7,000

 

 

 

-

 

 

 

7

 

 

 

-

 

 

 

-

 

 

 

7

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

2,276

 

 

 

-

 

 

 

-

 

 

 

2,276

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(24,038

)

 

 

(24,038

)

Net unrealized gain on marketable

   securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

183

 

 

 

-

 

 

 

183

 

Balances as of June 30, 2019

 

 

68,701,043

 

 

$

7

 

 

$

806,001

 

 

$

228

 

 

$

(570,177

)

 

$

236,059

 

 

See accompanying notes to the condensed consolidated financial statements.

 

6


 

CymaBay Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share information)

(unaudited)

 

 

 

Three and Six Months Ended June 30, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balances as of December 31, 2017

 

 

44,408,796

 

 

$

4

 

 

$

535,503

 

 

$

(44

)

 

$

(450,516

)

 

$

84,947

 

Issuance of common stock upon

   exercise of warrants

 

 

297,144

 

 

 

-

 

 

 

3,753

 

 

 

-

 

 

 

-

 

 

 

3,753

 

Issuance of common stock upon

   exercise of stock options

   and incentive awards

 

 

667,656

 

 

 

-

 

 

 

3,276

 

 

 

-

 

 

 

-

 

 

 

3,276

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

1,796

 

 

 

-

 

 

 

-

 

 

 

1,796

 

Issuance of common stock, net of

   $8,553 issuance costs

 

 

13,340,000

 

 

 

2

 

 

 

135,518

 

 

 

-

 

 

 

-

 

 

 

135,520

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(17,005

)

 

 

(17,005

)

Net unrealized loss on marketable

   securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(88

)

 

 

-

 

 

 

(88

)

Balances as of March 31, 2018

 

 

58,713,596

 

 

$

6

 

 

$

679,846

 

 

$

(132

)

 

$

(467,521

)

 

$

212,199

 

Issuance of common stock upon

   exercise of warrants

 

 

185,507

 

 

 

-

 

 

 

2,484

 

 

 

-

 

 

 

-

 

 

 

2,484

 

Issuance of common stock upon

   exercise of stock options

   and incentive awards

 

 

60,833

 

 

 

-

 

 

 

245

 

 

 

-

 

 

 

-

 

 

 

245

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

1,751

 

 

 

-

 

 

 

-

 

 

 

1,751

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(17,531

)

 

 

(17,531

)

Net unrealized gain on marketable

   securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

65

 

 

 

-

 

 

 

65

 

Balances as of June 30, 2018

 

 

58,959,936

 

 

$

6

 

 

$

684,326

 

 

$

(67

)

 

$

(485,052

)

 

$

199,213

 

 

See accompanying notes to the condensed consolidated financial statements.

7


 

CymaBay Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(unaudited)

1. Organization and Description of Business

CymaBay Therapeutics, Inc. (the Company or CymaBay) is a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need. The Company’s key clinical development candidate is seladelpar (MBX-8025). Seladelpar is currently being developed or evaluated for the treatment of the liver diseases primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH). The Company was incorporated in Delaware in October 1988 as Transtech Corporation. The Company’s headquarters and operations are located in Newark, California and it operates in one segment.

Liquidity

The Company has incurred net operating losses and negative cash flows from operations since its inception. During the six months ended June 30, 2019, the Company incurred a net loss of $47.1 million and used $46.6 million of cash in operations. At June 30, 2019, the Company had an accumulated deficit of $570.2 million. CymaBay expects to incur substantial research and development expenses as it continues to study its product candidates in clinical trials. To date, none of the Company’s product candidates have been approved for marketing and sale, and the Company has not recorded any revenue from product sales. As a result, management expects operating losses to continue in future years. The Company’s ability to achieve profitability is dependent primarily on its ability to successfully develop, acquire or in-license additional product candidates, continue clinical trials for product candidates currently in clinical development, obtain regulatory approvals, and support commercialization activities for its product candidates. Products developed by the Company will require approval of the U.S. Food and Drug Administration (FDA) or a foreign regulatory authority prior to commercial sale. The regulatory approval process is expensive, time-consuming, and uncertain, and any denial or delay of approval could have a material adverse effect on the Company. Even if approved, the Company’s products may not achieve market acceptance and will face competition from both generic and branded pharmaceutical products.

As of June 30, 2019, the Company had cash, cash equivalents and marketable securities totaling $241.2 million which the Company believes is sufficient to fund its current operating plan into 2021. The Company expects to incur substantial expenditures in the future for the development and potential commercialization of its product candidates. Because of this, the Company expects its future liquidity and capital resource needs will be impacted by numerous factors, including but not limited to, costs for the Company’s Phase 2 clinical trial in PSC, the ongoing Phase 2b clinical trial activities in NASH, and most significantly, the timing and conduct of PBC development activities. The Company’s PBC development activities include two Phase 3 clinical trials, one of which is a long-term open label study, and other new drug application (NDA)-enabling studies. The Company has obtained and expects to obtain additional funding to develop its products and fund future operating losses, as appropriate, through equity offerings; debt financing; one or more possible licenses, collaborations or other similar arrangements with respect to development and/or commercialization rights of its product candidates; or a combination of the above. It is unclear if or when any such transactions will occur, on satisfactory terms or at all. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and its ability to pursue its business strategies. If adequate funds are not available to the Company, it could have a material adverse effect on its business, results of operations, and financial condition.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying interim condensed consolidated financial statements are unaudited and are comprised of CymaBay and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The Company has no unconsolidated subsidiaries or investments accounted for under the equity method.

These unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) and following the requirements of the United States Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted.

8


 

In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements and include normal recurring adjustments necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the fiscal year ended December 31, 2018, which is contained in the Company’s Annual Report on Form 10-K as filed with the SEC on February 28, 2019. The results for the three and six months ended June 30, 2019 are not necessarily indicative of results to be expected for the entire year ending December 31, 2019 or future operating periods.

Use of Estimates

The condensed consolidated financial statements have been prepared in accordance with GAAP, which requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from those estimates and assumptions. The Company believes significant judgment can be involved in estimating stock-based compensation, accrued clinical expenses, and the fair value of the Company’s common stock warrants. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each reporting period and updated to reflect current information and any changes in estimates will be reflected in the period first identified.

Fair Value of Financial Instruments

The Company’s financial instruments during the periods reported consist of cash and cash equivalents, marketable securities, accrued interest receivable, prepaid expenses, other assets, accounts payable and accrued expenses. Fair value estimates of these instruments are made at a specific point in time based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of significant judgment. The carrying amounts of financial instruments such as cash and cash equivalents, accrued interest receivable, prepaid expenses, other assets, accounts payable, and accrued expenses approximate the related fair values due to the short maturities of these instruments.

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and maximizes the use of unobservable inputs and is as follows:

Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

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

Level 3—Inputs that are significant to the fair value measurement and are unobservable (i.e. supported by little market activity), which requires the reporting entity to develop its own valuation techniques and assumptions.

9


 

The following tables present the fair value of the Company’s financial assets and liabilities measured at fair value on a recurring basis using the above input categories (in thousands):

 

 

 

As of June 30, 2019

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total Fair Value

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

24,168

 

 

$

-

 

 

$

-

 

 

$

24,168

 

Total cash equivalents

 

 

24,168

 

 

 

-

 

 

 

-

 

 

 

24,168

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. and foreign commercial paper

 

 

-

 

 

 

57,509

 

 

 

-

 

 

 

57,509

 

U.S. and foreign corporate debt securities

 

 

-

 

 

 

60,011

 

 

 

-

 

 

 

60,011

 

Asset-backed securities

 

 

-

 

 

 

47,340