Ardelyx (ARDX) 10-Q 7 Nov 16 2016 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2016	Nov. 01, 2016
Document And Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2016
Document Fiscal Year Focus	2,016
Document Fiscal Period Focus	Q3
Trading Symbol	ARDX
Entity Registrant Name	Ardelyx, Inc.
Entity Central Index Key	1,437,402
Current Fiscal Year End Date	--12-31
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding		47,301,894

Condensed Balance Sheets

Condensed Balance Sheets - USD ($) $ in Thousands		Sep. 30, 2016	Dec. 31, 2015
Current assets:
Cash and cash equivalents		$ 160,360	$ 107,004	[1]
Short-term investments		69,726
Prepaid expenses and other current assets		4,114	5,027	[1]
Total current assets		234,200	112,031	[1]
Property and equipment, net		6,969	4,711	[1]
Other assets		148	104	[1]
Restricted cash	[1]		100
Total assets		241,317	116,946	[1]
Current liabilities:
Accounts payable		6,298	2,777	[1]
Accrued compensation and benefits		2,227	2,366	[1]
Accrued and other liabilities		9,110	2,580	[1]
Total current liabilities		17,635	7,723	[1]
Other long-term liabilities		789	322	[1]
Total liabilities		18,424	8,045	[1]
Commitments and contingencies				[1]
Stockholders' equity:
Preferred stock, $0.0001 par value; 5,000,000 shares authorized as of September 30, 2016 and December 31, 2015, respectively; no shares issued and outstanding as of September 30, 2016 and December 31, 2015, respectively.				[1]
Common stock, $0.0001 par value; 300,000,000 shares authorized as of September 30, 2016 and December 31, 2015, respectively; 47,295,834 and 25,964,886 shares issued and outstanding as of September 30 2016 and December 31, 2015, respectively.		5	3	[1]
Additional paid-in capital		405,514	210,386	[1]
Accumulated other comprehensive loss		(25)
Accumulated deficit		(182,601)	(101,488)	[1]
Total stockholders' equity		222,893	108,901	[1]
Total liabilities and stockholders' equity		$ 241,317	$ 116,946	[1]
[1]	Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015.

Condensed Balance Sheets (Paren

Condensed Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2016	Dec. 31, 2015	[1]
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	300,000,000	300,000,000
Common stock, shares issued	47,295,834	25,964,886
Common stock, shares outstanding	47,295,834	25,964,886
[1]	Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015.

Condensed Statements of Operati

Condensed Statements of Operations - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Revenue:
Licensing revenue				$ 21,611
Collaborative development revenue				2,415
Total revenue				24,026
Operating expenses:
Research and development	$ 24,863	$ 14,705	$ 67,951	27,101
General and administrative	4,337	3,374	13,469	9,438
Total operating expenses	29,200	18,079	81,420	36,539
Loss from operations	(29,200)	(18,079)	(81,420)	(12,513)
Other income (expense), net	169	(77)	307	(138)
Loss before provision for income taxes	(29,031)	(18,156)	(81,113)	(12,651)
Provision for income taxes		30		30
Net loss	$ (29,031)	$ (18,126)	$ (81,113)	$ (12,621)
Net loss per common share, basic and diluted	$ (0.65)	$ (0.70)	$ (2.15)	$ (0.58)
Shares used in computing basic net loss per share, basic and diluted	44,935,126	25,930,928	37,706,045	21,859,383

Condensed Statements of Compreh

Condensed Statements of Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Statement of Comprehensive Income [Abstract]
Net loss	$ (29,031)	$ (18,126)	$ (81,113)	$ (12,621)
Unrealized loss on available-for-sale securities, net of tax	(25)		(25)
Comprehensive loss	$ (29,056)	$ (18,126)	$ (81,138)	$ (12,621)

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2016		Sep. 30, 2015
Operating activities
Net loss	$ (81,113)		$ (12,621)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense	904		540
Amortization of deferred financing costs	289		88
Amortization of deferred compensation for services	148
Amortization of premium on investment securities	(11)
Stock-based compensation	3,767		1,877
Loss from disposal of fixed assets			64
Changes in operating assets and liabilities:
Accounts receivable			2,584
Prepaid expenses and other assets	719		(3,107)
Accounts payable	2,678		(281)
Accrued compensation and benefits	(139)		48
Accrued and other liabilities	6,785		7,624
Deferred revenue			(47,053)
Net cash used in operating activities	(65,973)		(50,237)
Investing activities
Purchases of short-term investments	(69,740)
Purchases of property and equipment	(2,108)		(3,000)
Net cash used in investing activities	(71,848)		(3,000)
Financing activities
Proceeds from issuance of common stock, net of issuance costs	190,574		74,322
Proceeds from issuance of common stock under stock plans	603		646
Other			30
Net cash provided by financing activities	191,177		74,998
Net increase in cash and cash equivalents	53,356		21,761
Cash and cash equivalents at beginning of period	107,004	[1]	107,286
Cash and cash equivalents at end of period	160,360		129,047
Supplemental cash flow disclosure:
Cash paid during the period for income taxes			$ 69
Supplemental noncash investing activities:
Acquisition of property and equipment included in accounts payable and accrued liabilities	$ 1,054
[1]	Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015.

Organization and Basis of Prese

Organization and Basis of Presentation	9 Months Ended
	Sep. 30, 2016
Accounting Policies [Abstract]
Organization and Basis of Presentation	NOTE 1. ORGANIZATION AND BASIS OF PRESENTATION Ardelyx, Inc., or “the Company,” is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative, minimally-systemic therapeutic drugs that work exclusively in the gastrointestinal, or GI, tract to treat cardio-renal and GI diseases. The Company has developed a proprietary drug discovery and design platform enabling it, in a rapid and cost-efficient manner, to discover and design novel drug candidates. Utilizing its platform, the Company discovered and designed its lead product candidate, tenapanor, which is currently being evaluated in two Phase 3 clinical trials in patients with irritable bowel syndrome with constipation, or IBS-C. In a Phase 2b clinical trial, tenapanor demonstrated the ability to lower elevated serum phosphorus levels in patients with end-stage renal disease, or ESRD, on dialysis. The Company has initiated the first of two Phase 3 clinical trials to evaluate efficacy, safety and dosing regimens of tenapanor for the treatment of hyperphosphatemia, or elevated serum phosphorus in ESRD patients on dialysis. The Company is developing another drug candidate, RDX227675, for the treatment of hyperkalemia, or elevated serum potassium. The Company is pursuing a 505(b)(2) regulatory pathway for RDX227675. The Company has additional drug candidates in earlier research and development programs focused in GI and cardio-renal diseases, including RDX98940, focused on secretagogues of glucagon-like peptide-1, or GLP-1, and glucagon-like peptide-2, or GLP-2, and RDX013 program compounds focused on potassium secretagogues. Basis of Presentation These unaudited condensed financial statements and the related footnote information of the Company have been prepared pursuant to the requirements of the Securities and Exchange Commission, or the SEC, for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information that are normally required by U.S. generally accepted accounting principles, or U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of the Company’s management, the accompanying interim unaudited condensed financial statements include all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of the information for the periods presented. The results for the quarter and nine months ended September 30, 2016 are not necessarily indicative of results to be expected for the entire year ending December 31, 2016 or future operating periods. The accompanying condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2015, included in the Company’s Annual Report on Form 10-K filed with the SEC (the “2015 Form 10-K”). The balance sheet at December 31, 2015 has been derived from the audited financial statements at that date, as filed with the 2015 Form 10-K.

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2016
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Although management believes these estimates are based upon reasonable assumptions within the bounds of its knowledge of the Company’s business and operations, actual results could differ materially from those estimates. Clinical Trial Accruals Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines estimated costs through discussions with internal personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities, are deferred and recognized as expense in the period that the related goods are delivered or services are performed. Recent Accounting Pronouncements In May, 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers - Revenue from Contracts with Customers In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In March 2016, the FASB issued Accounting Standards 2016-09, Improvements to Employee Share-Based Payment Accounting In August 2016, the FASB issued Accounting Standards Update (ASU) 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments The Company has reviewed all other significant newly-issued accounting pronouncements and concluded that they either are not applicable to the Company’s operations or that no material effect is expected on its condensed financial statements as a result of future adoption.

Cash Equivalents and Investment

Cash Equivalents and Investments	9 Months Ended
	Sep. 30, 2016
Cash and Cash Equivalents [Abstract]
Cash Equivalents and Investments	NOTE 3. CASH EQUIVALENTS AND INVESTMENTS Securities classified as cash and cash equivalents and short-term investments as of September 30, 2016 and December 31, 2015 are summarized below (in thousands). Estimated fair value is based on quoted market prices for these investments. September 30, 2016 Amortized Gross Unrealized Cost Gains Losses Fair Value Cash and cash equivalents: Cash $ 3,782 $ — $ — $ 3,782 Money market funds 137,412 — — 137,412 Corporate bonds 6,166 — — 6,166 Commercial paper 13,000 — — 13,000 Total cash and cash equivalents $ 160,360 $ — $ — $ 160,360 Short-term investments Corporate bonds 30,565 — (20 ) $ 30,545 Commercial paper 39,186 9 (14 ) 39,181 Total short-term investments $ 69,751 $ 9 $ (34 ) $ 69,726 Total $ 230,111 $ 9 $ (34 ) $ 230,086 December 31, 2015 Amortized Gross Unrealized Cost Gains Losses Fair Value Cash and cash equivalents: Cash 1,185 $ — $ — $ 1,185 Money market funds $ 105,819 $ — $ — $ 105,819 Total cash and cash equivalents $ 107,004 $ — $ — $ 107,004 Cash equivalents consist of money market funds and corporate debt securities with original maturities of three months or less at the time of purchase, and the carrying amount is a reasonable estimate of fair value. The Company invests its cash in high quality securities of financial and commercial institutions. These securities are carried at fair value, which is based on readily available market information, with unrealized gains and losses included in “accumulated other comprehensive loss” within stockholders’ equity on the Company’s condensed balance sheets. The Company uses the specific identification method to determine the amount of realized gains or losses on sales of marketable securities. For the three and nine-month period ended September 30, 2016, there were no realized gains or losses on the available-for-sale securities. All available-for-sale securities held as of September 30, 2016 had contractual maturities of less than one year. Investments that have maturities beyond one year as of the end of the reporting period are classified as non-current. The Company’s available-for-sale securities are subject to a periodic impairment review. The Company considers a debt security to be impaired when its fair value is less than its carrying cost, in which case the Company would further review the investment to determine whether it is other-than-temporarily impaired. When the Company evaluates an investment for other-than-temporary impairment, the Company reviews factors such as the length of time and extent to which fair value has been below cost basis, the financial condition of the issuer and any changes thereto, intent to sell, and whether it is more likely than not the Company will be required to sell the investment before the recovery of its cost basis. If an investment is other-than-temporarily impaired, the Company writes it down through the statement of operations to its fair value and establishes that value as a new cost basis for the investment. The Company did not identify any of its available-for-sale securities as other-than-temporarily impaired in any of the periods presented. As of September 30, 2016, no investment was in a continuous unrealized loss position for more than one year, the unrealized losses were not due to change in credit risk and the Company believes that is more likely than not the investments will be held until maturity or a forecasted recovery of fair value.

Fair Value Measurements

Fair Value Measurements	9 Months Ended
	Sep. 30, 2016
Fair Value Disclosures [Abstract]
Fair Value Measurements	NOTE 4. FAIR VALUE MEASUREMENTS 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 on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows: Level 1 – Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and trading securities with quoted prices on active markets. Level 2 – Valuations based on inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Examples of assets and liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds, commercial paper, certificates of deposit and over-the-counter derivatives. Level 3 – Valuations based on unobservable inputs in which there is little or no market data, which require us to develop our own assumptions. The following table sets forth the fair value of the Company’s financial assets measured on a recurring basis by level within the fair value hierarchy (in thousands): September 30, 2016 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 137,412 $ 137,412 $ — $ — Corporate bonds 36,711 — 36,711 — Commercial paper 52,181 — 52,181 — Total $ 226,304 $ 137,412 $ 88,892 $ — December 31, 2015 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 105,819 $ 105,819 $ — $ — Certificates of deposit 100 — 100 — Total $ 105,919 $ 105,819 $ 100 $ — Where quoted prices are available in an active market, securities are classified as Level 1. The Company classifies money market funds as Level 1. When quoted market prices are not available for the specific security, then the Company estimates fair value by using benchmark yields, reported trades, broker/dealer quotes, and issuer spreads. The Company classifies certificates of deposit, corporate bonds and commercial paper as Level 2. In certain cases where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3. There were no transfers between Level 1 and Level 2 during the periods presented. The carrying amounts reflected in the condensed balance sheets for cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values at September 30, 2016 and December 31, 2015, due to their short-term nature.

Collaboration and Licensing Agr

Collaboration and Licensing Agreements	9 Months Ended
	Sep. 30, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Collaboration and Licensing Agreements	NOTE 5. COLLABORATION AND LICENSING AGREEMENTS AstraZeneca AB (“AstraZeneca”) In October 2012, the Company entered into a collaboration partnership with AstraZeneca for the worldwide development and commercialization of tenapanor. Under the terms of the AstraZeneca collaboration partnership agreement, or the AstraZeneca Agreement, the Company received $75.0 million in up-front license fees and milestone payments which were recorded as deferred revenue when received and recognized as revenue on a straight-line basis over the remaining estimated period of performance under the AstraZeneca Agreement, which, prior to its termination in June 2015, we estimated to be December 2017. In June 2015, the Company entered into a termination agreement with AstraZeneca (the “Termination Agreement”) pursuant to which all licenses granted to AstraZeneca to the Company’s portfolio of NHE3 inhibitors, including the Company’s lead product candidate, tenapanor, were terminated, except for the limited purpose of allowing AstraZeneca to satisfy its obligations under the Termination Agreement. Concurrent with the Termination Agreement, the Company recognized all remaining deferred revenue.

Stock-Based Compensation

Stock-Based Compensation	9 Months Ended
	Sep. 30, 2016
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Stock-Based Compensation	NOTE 6. STOCK-BASED COMPENSATION The following table presents stock-based compensation expense recognized for stock options, restricted stock units and the Company’s employee stock purchase program, or ESPP, in the Company’s statements of operations (in thousands): Three Months Ended Nine Months Ended 2016 2015 2016 2015 Research and development $ 685 $ 333 $ 1,992 $ 965 General and administrative 606 379 1,775 912 Total $ 1,291 $ 712 $ 3,767 $ 1,877 At September 30, 2016, the Company had $10.7 million, $0.8 million and $0.1 million of total unrecognized compensation expense, net of estimated forfeitures, related to stock option grants, restricted stock unit grants and ESPP, respectively, that will be recognized over an average vesting period of 3.0 years, 3.2 years and 0.4 years, respectively.

Net Loss Per Share

Net Loss Per Share	9 Months Ended
	Sep. 30, 2016
Earnings Per Share [Abstract]
Net Loss Per Share	NOTE 7. NET LOSS PER SHARE Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed giving effect to all potential dilutive common shares, including common stock issuable upon exercise of stock options, and unvested restricted common stock and stock units. The Company uses the treasury-stock method to compute diluted earnings per share with respect to its stock options and common stock equivalents. For purposes of this calculation, options to purchase stock are considered to be potential common shares and are only included in the calculation of diluted net loss per share when their effect is dilutive. Basic and diluted loss per share are calculated as follows (in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Numerator: Net loss $ (29,031 ) $ (18,126 ) $ (81,113 ) $ (12,621 ) Denominator: Weighted average common shares outstanding - basic and diluted 44,935,126 25,930,928 37,706,045 21,859,383 Net loss per share - basic and diluted $ (0.65 ) $ (0.70 ) $ (2.15 ) $ (0.58 ) For the three and nine months ended September 30, 2016, the total number of anti-dilutive outstanding common stock equivalents excluded from the net loss per common share computation was 4.7 million and 4.6 million, respectively. For the three and nine months ended September 30, 2015 the total number of anti-dilutive outstanding common stock equivalents excluded from the net loss per common share computation was 1.8 million and 1.4 million, respectively.

Accrued and Other Liabilities

Accrued and Other Liabilities	9 Months Ended
	Sep. 30, 2016
Payables and Accruals [Abstract]
Accrued and Other Liabilities	NOTE 8. ACCRUED AND OTHER LIABILITIES Accrued liabilities and other liabilities consist of the following (in thousands) September 30, December 31, 2016 2015 Accrued clinical trial expenses $ 5,916 $ 311 Accrued contract manufacturing 2,083 289 Accrued professional and consulting services 287 272 AZ clinical trial material accrual — 1,328 Other 824 380 $ 9,110 $ 2,580

Stockholders' Equity

Stockholders' Equity	9 Months Ended
	Sep. 30, 2016
Equity [Abstract]
Stockholders' Equity	NOTE 9. STOCKHOLDERS’ EQUITY Option Exercises For the three and nine months ended September 30, 2016, employees exercised options to purchase 10,331 and 16,581 shares, respectively, of the Company’s common stock with insignificant net proceeds to the Company. For the three and nine months ended September 30, 2015, employees and consultants exercised options to purchase 21,438 and 67,839 shares of the Company’s common stock, respectively, with net proceeds to the Company of insignificant and $0.1 million, respectively. Employee Stock Purchase Plan In February 2016, the Company sold 34,012 shares under the ESPP. The shares were purchased at a purchase price of $8.21 per share with proceeds to the Company of approximately $0.3 million. In August 2016, the Company sold 35,042 shares under the ESPP. The shares were purchased at a purchase price of $8.47 per share with proceeds to the Company of approximately $0.3 million. Offerings of Common Stock and Warrants In June 2015, the Company sold and issued an aggregate of 7,242,992 shares of its common stock and warrants to purchase 2,172,899 shares of common stock in a private placement transaction for aggregate gross proceeds of approximately $77.8 million or net proceeds, after deducting issuance costs, of approximately $74.3 million. The purchase price for the common stock was $10.70 per share and the purchase price for the warrants was $0.125 per warrant. The warrants are exercisable at an exercise price of $13.91 per share at any time prior to the earlier of (i) 5 years from the date of issuance or (ii) certain changes in control of the Company. The Company has determined that the warrants should be classified as equity. In July 2015, the Company filed a registration statement with the SEC registering the resale of the common stock and shares of common stock underlying the warrants sold and issued in the private placement transaction. Other than with respect to warrants issued to holders affiliated with New Enterprise Associates, the warrants contain limitations that prevent each holder of warrants from acquiring shares upon exercise of the warrants that would cause the number of shares beneficially owned by it and its affiliates to exceed 9.99% of the total number of shares of the Company’s common stock then issued and outstanding. In addition, upon certain changes in control of the Company, each holder of a warrant can elect to receive, subject to certain limitations and assumptions, securities in a successor entity. None of the warrants issued in June 2015 have been exercised as of September 30, 2016. In January 2016, the Company completed an underwritten public offering of 8,625,000 shares of common stock at an offering price of $10.00 per share for gross proceeds of $86.3 million. The Company received net proceeds from the offering of approximately $80.8 million, after deducting the underwriters’ discounts and commissions and offering expenses. In July 2016, the Company sold and issued an aggregate of 12,600,230 shares of common stock in a private placement transaction at an offering price of $8.73 per share for gross proceeds of $110.0 million. The Company received net proceeds from the offering of approximately $109.7 million, after deducting offering expenses. In August 2016, the Company filed a registration statement with the SEC registering the resale of the common stock sold and issued in the private placement transaction.

Subsequent Events

Subsequent Events	9 Months Ended
	Sep. 30, 2016
Subsequent Events [Abstract]
Subsequent Events	NOTE 10. SUBSEQUENT EVENTS

Summary of Significant Accoun17

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2016
Fair Value Disclosures [Abstract]
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Although management believes these estimates are based upon reasonable assumptions within the bounds of its knowledge of the Company’s business and operations, actual results could differ materially from those estimates.
Clinical Trial Accruals	Clinical Trial Accruals Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines estimated costs through discussions with internal personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities, are deferred and recognized as expense in the period that the related goods are delivered or services are performed.
Recent Accounting Pronouncements	Recent Accounting Pronouncements In May, 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers - Revenue from Contracts with Customers In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In March 2016, the FASB issued Accounting Standards 2016-09, Improvements to Employee Share-Based Payment Accounting In August 2016, the FASB issued Accounting Standards Update (ASU) 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments The Company has reviewed all other significant newly-issued accounting pronouncements and concluded that they either are not applicable to the Company’s operations or that no material effect is expected on its condensed financial statements as a result of future adoption.
Fair Value Measurements	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 on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows: Level 1 – Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and trading securities with quoted prices on active markets. Level 2 – Valuations based on inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Examples of assets and liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds, commercial paper, certificates of deposit and over-the-counter derivatives. Level 3 – Valuations based on unobservable inputs in which there is little or no market data, which require us to develop our own assumptions.

Cash Equivalents and Investme18

Cash Equivalents and Investments (Tables)	9 Months Ended
	Sep. 30, 2016
Cash and Cash Equivalents [Abstract]
Schedule of Securities Classified as Cash and Cash Equivalents and Short-term Investments	Securities classified as cash and cash equivalents and short-term investments as of September 30, 2016 and December 31, 2015 are summarized below (in thousands). Estimated fair value is based on quoted market prices for these investments. September 30, 2016 Amortized Gross Unrealized Cost Gains Losses Fair Value Cash and cash equivalents: Cash $ 3,782 $ — $ — $ 3,782 Money market funds 137,412 — — 137,412 Corporate bonds 6,166 — — 6,166 Commercial paper 13,000 — — 13,000 Total cash and cash equivalents $ 160,360 $ — $ — $ 160,360 Short-term investments Corporate bonds 30,565 — (20 ) $ 30,545 Commercial paper 39,186 9 (14 ) 39,181 Total short-term investments $ 69,751 $ 9 $ (34 ) $ 69,726 Total $ 230,111 $ 9 $ (34 ) $ 230,086 December 31, 2015 Amortized Gross Unrealized Cost Gains Losses Fair Value Cash and cash equivalents: Cash 1,185 $ — $ — $ 1,185 Money market funds $ 105,819 $ — $ — $ 105,819 Total cash and cash equivalents $ 107,004 $ — $ — $ 107,004

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
	Sep. 30, 2016
Fair Value Disclosures [Abstract]
Summary of Fair Value Measurements of Company's Financial Assets	The following table sets forth the fair value of the Company’s financial assets measured on a recurring basis by level within the fair value hierarchy (in thousands): September 30, 2016 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 137,412 $ 137,412 $ — $ — Corporate bonds 36,711 — 36,711 — Commercial paper 52,181 — 52,181 — Total $ 226,304 $ 137,412 $ 88,892 $ — December 31, 2015 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 105,819 $ 105,819 $ — $ — Certificates of deposit 100 — 100 — Total $ 105,919 $ 105,819 $ 100 $ —

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	9 Months Ended
	Sep. 30, 2016
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Summary of Stock-Based Compensation Recognized	The following table presents stock-based compensation expense recognized for stock options, restricted stock units and the Company’s employee stock purchase program, or ESPP, in the Company’s statements of operations (in thousands): Three Months Ended Nine Months Ended 2016 2015 2016 2015 Research and development $ 685 $ 333 $ 1,992 $ 965 General and administrative 606 379 1,775 912 Total $ 1,291 $ 712 $ 3,767 $ 1,877

Net Loss Per Share (Tables)

Net Loss Per Share (Tables)	9 Months Ended
	Sep. 30, 2016
Earnings Per Share [Abstract]
Computation of Basic and Diluted Loss Per Share Attributable to Common Stockholders	Basic and diluted loss per share are calculated as follows (in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Numerator: Net loss $ (29,031 ) $ (18,126 ) $ (81,113 ) $ (12,621 ) Denominator: Weighted average common shares outstanding - basic and diluted 44,935,126 25,930,928 37,706,045 21,859,383 Net loss per share - basic and diluted $ (0.65 ) $ (0.70 ) $ (2.15 ) $ (0.58 )

Accrued and Other Liabilities (

Accrued and Other Liabilities (Tables)	9 Months Ended
	Sep. 30, 2016
Payables and Accruals [Abstract]
Schedule of Accrued Liabilities and Other Liabilities	Accrued liabilities and other liabilities consist of the following (in thousands) September 30, December 31, 2016 2015 Accrued clinical trial expenses $ 5,916 $ 311 Accrued contract manufacturing 2,083 289 Accrued professional and consulting services 287 272 AZ clinical trial material accrual — 1,328 Other 824 380 $ 9,110 $ 2,580

Cash Equivalents and Investme23

Cash Equivalents and Investments - Schedule of Securities Classified as Cash and Cash Equivalents and Short-term Investments (Detail) - USD ($) $ in Thousands	Sep. 30, 2016	Dec. 31, 2015		Sep. 30, 2015	Dec. 31, 2014
Cash Cash Equivalents And Short Term Investments [Line Items]
Cash and cash equivalents, Amortized Cost	$ 160,360	$ 107,004	[1]	$ 129,047	$ 107,286
Cash and cash equivalents, Gross Unrealized Gains	0	0
Cash and cash equivalents, Gross Unrealized Losses	0	0
Cash and cash equivalents, Fair Value	160,360	107,004
Short-term investments, Amortized Cost	69,751
Short-term investments, Gross Unrealized Gains	9
Short-term investments, Gross Unrealized Losses	(34)
Short-term investments, Fair Value	69,726
Cash equivalents and short-term investments, Amortized Cost	230,111
Cash equivalents and short-term investments, Gross Unrealized Gains	9
Cash equivalents and short-term investments, Gross Unrealized Losses	(34)
Cash equivalents and short-term investments, Fair Value	230,086
Cash [Member]
Cash Cash Equivalents And Short Term Investments [Line Items]
Cash and cash equivalents, Amortized Cost	3,782	1,185
Cash and cash equivalents, Gross Unrealized Gains	0	0
Cash and cash equivalents, Gross Unrealized Losses	0	0
Cash and cash equivalents, Fair Value	3,782	1,185
Money Market Funds [Member]
Cash Cash Equivalents And Short Term Investments [Line Items]
Cash and cash equivalents, Amortized Cost	137,412	105,819
Cash and cash equivalents, Gross Unrealized Gains	0	0
Cash and cash equivalents, Gross Unrealized Losses	0	0
Cash and cash equivalents, Fair Value	137,412	$ 105,819
Corporate Bonds (Cash Equivalents) [Member]
Cash Cash Equivalents And Short Term Investments [Line Items]
Cash and cash equivalents, Amortized Cost	6,166
Cash and cash equivalents, Gross Unrealized Gains	0
Cash and cash equivalents, Gross Unrealized Losses	0
Cash and cash equivalents, Fair Value	6,166
Commercial Paper (Cash Equivalents) [Member]
Cash Cash Equivalents And Short Term Investments [Line Items]
Cash and cash equivalents, Amortized Cost	13,000
Cash and cash equivalents, Gross Unrealized Gains	0
Cash and cash equivalents, Gross Unrealized Losses	0
Cash and cash equivalents, Fair Value	13,000
Corporate Bonds (Investments) [Member]
Cash Cash Equivalents And Short Term Investments [Line Items]
Short-term investments, Amortized Cost	30,565
Short-term investments, Gross Unrealized Losses	(20)
Short-term investments, Fair Value	30,545
Commercial Paper (Investments) [Member]
Cash Cash Equivalents And Short Term Investments [Line Items]
Short-term investments, Amortized Cost	39,186
Short-term investments, Gross Unrealized Gains	9
Short-term investments, Gross Unrealized Losses	(14)
Short-term investments, Fair Value	$ 39,181
[1]	Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015.

Cash Equivalents and Investme24

Cash Equivalents and Investments - Additional Information (Detail)	3 Months Ended	9 Months Ended
	Sep. 30, 2016USD ($)	Sep. 30, 2016USD ($)
Cash Cash Equivalents And Short Term Investments [Line Items]
Available-for-sale securities, realized gains or losses	$ 0	$ 0
Investment in continuous unrealized loss position for more than one year	$ 0	$ 0
Maximum [Member]
Cash Cash Equivalents And Short Term Investments [Line Items]
Available for sale securities contractual maturity period		1 year

Fair Value Measurements - Summa

Fair Value Measurements - Summary of Fair Value Measurements of Company's Financial Assets (Detail) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Sep. 30, 2016	Dec. 31, 2015
Assets:
Assets at fair value	$ 226,304	$ 105,919
Level 1 [Member]
Assets:
Assets at fair value	137,412	105,819
Level 2 [Member]
Assets:
Assets at fair value	88,892	100
Money Market Funds [Member]
Assets:
Assets at fair value	137,412	105,819
Money Market Funds [Member] | Level 1 [Member]
Assets:
Assets at fair value	137,412	105,819
Certificates of Deposit [Member]
Assets:
Assets at fair value		100
Certificates of Deposit [Member] | Level 2 [Member]
Assets:
Assets at fair value		$ 100
Corporate Bonds [Member]
Assets:
Assets at fair value	36,711
Corporate Bonds [Member] | Level 2 [Member]
Assets:
Assets at fair value	36,711
Commercial Paper [Member]
Assets:
Assets at fair value	52,181
Commercial Paper [Member] | Level 2 [Member]
Assets:
Assets at fair value	$ 52,181

Fair Value Measurements - Addit

Fair Value Measurements - Additional Information (Detail)	Sep. 30, 2016USD ($)
Fair Value Disclosures [Abstract]
Transfer of assets from Level 1 to Level 2	$ 0
Transfer of assets from Level 2 to Level 1	$ 0

Collaboration and Licensing A27

Collaboration and Licensing Agreements - Additional Information (Detail) $ in Millions	1 Months Ended
	Oct. 31, 2012USD ($)
AstraZeneca [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Upfront payment received	$ 75

Stock-Based Compensation - Summ

Stock-Based Compensation - Summary of Stock-Based Compensation Expense Recognized (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation	$ 1,291	$ 712	$ 3,767	$ 1,877
Research and Development [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation	685	333	1,992	965
General and Administrative [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation	$ 606	$ 379	$ 1,775	$ 912

Stock-Based Compensation - Addi

Stock-Based Compensation - Additional Information (Detail) $ in Millions	9 Months Ended
	Sep. 30, 2016USD ($)
Options to Purchase Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized stock based compensation expense	$ 10.7
Unrecognized stock based compensation expense, weighted-average remaining recognition period	3 years
Restricted Stock Units (RSUs) [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized stock based compensation expense	$ 0.8
Unrecognized stock based compensation expense, weighted-average remaining recognition period	3 years 2 months 12 days
Employee Stock Purchase Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized stock based compensation expense	$ 0.1
Unrecognized stock based compensation expense, weighted-average remaining recognition period	4 months 24 days

Net Loss Per Share - Computatio

Net Loss Per Share - Computation of Basic and Diluted Loss Per Share Attributable to Common Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Numerator:
Net loss	$ (29,031)	$ (18,126)	$ (81,113)	$ (12,621)
Denominator:
Weighted average common shares outstanding - basic and diluted	44,935,126	25,930,928	37,706,045	21,859,383
Net loss per share - basic and diluted	$ (0.65)	$ (0.70)	$ (2.15)	$ (0.58)

Net Loss Per Share - Additional

Net Loss Per Share - Additional Information (Detail) - shares shares in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Earnings Per Share [Abstract]
Anti-dilutive securities excluded from computation of diluted net loss per share attributable to common stockholders	4.7	1.8	4.6	1.4

Accrued and Other Liabilities -

Accrued and Other Liabilities - Schedule of Accrued Liabilities and Other Liabilities (Detail) - USD ($) $ in Thousands	Sep. 30, 2016	Dec. 31, 2015
Payables and Accruals [Abstract]
Accrued clinical trial expenses	$ 5,916	$ 311
Accrued contract manufacturing	2,083	289
Accrued professional and consulting services	287	272
AZ clinical trial material accrual		1,328
Other	824	380
Accrued liabilities and other liabilities	$ 9,110	$ 2,580	[1]
[1]	Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015.

Stockholders' Equity - Addition

Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended					3 Months Ended		9 Months Ended
	Aug. 31, 2016	Jul. 31, 2016	Feb. 29, 2016	Jan. 31, 2016	Jun. 30, 2015	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Purchase price of common shares				$ 10	$ 10.70
Gross proceeds from issuance of common stock				$ 86,300	$ 77,800
Proceeds from issuance of common stock, net of issuance costs				$ 80,800	$ 74,300			$ 190,574	$ 74,322
Common stock sold and issued				8,625,000	7,242,992
Warrants issued to purchase common stock					2,172,899
Purchase price for warrants					$ 0.125
Warrants exercise price per share					$ 13.91
Warrants expiration term					5 years
Warrants description								The warrants are exercisable at an exercise price of $13.91 per share at any time prior to the earlier of (i) 5 years from the date of issuance or (ii) certain changes in control of the Company.
Maximum warrants ownership percentage by each holder of warrants					9.99%
Number of warrants exercised								0
Private Placement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Purchase price of common shares		$ 8.73
Gross proceeds from issuance of common stock		$ 110,000
Proceeds from issuance of common stock, net of issuance costs		$ 109,700
Common stock sold and issued		12,600,230
Employees and Consultants [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares purchased by employees on exercise of options							21,438		67,839
Proceeds from exercise of stock options									$ 100
Employee Stock Purchase Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares sold under ESPP	35,042		34,012
Purchase price of common shares	$ 8.47		$ 8.21
Proceeds from issuance of shares under the ESPP	$ 300		$ 300
Options to Purchase Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares purchased by employees on exercise of options						10,331		16,581