Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 04, 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 | CALA | |
Entity Registrant Name | Calithera Biosciences, Inc. | |
Entity Central Index Key | 1,496,671 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 20,737,993 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 11,600 | $ 6,105 |
Short-term investments | 44,671 | 63,823 |
Prepaid expenses and other current assets | 1,616 | 2,567 |
Total current assets | 57,887 | 72,495 |
Long-term investments | 1,997 | |
Restricted cash | 46 | 46 |
Property and equipment, net | 915 | 931 |
Other assets | 76 | 281 |
Total assets | 58,924 | 75,750 |
Current liabilities: | ||
Accounts payable | 1,265 | 562 |
Accrued liabilities | 3,480 | 3,271 |
Total current liabilities | 4,745 | 3,833 |
Deferred rent | 368 | 129 |
Total liabilities | 5,113 | 3,962 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.0001 par value, 200,000 shares authorized as of September 30, 2016 and December 31, 2015; 20,100 and 18,232 shares issued and outstanding as of September 30, 2016 and December 31, 2015, respectively | 2 | 2 |
Additional paid-in capital | 167,042 | 156,353 |
Accumulated deficit | (112,982) | (84,498) |
Accumulated other comprehensive gain (loss) | (4) | (69) |
Receivables from sales under the ATM program (Note 6) | (247) | |
Total stockholders’ equity | 53,811 | 71,788 |
Total liabilities and stock and stockholders’ equity | $ 58,924 | $ 75,750 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 20,100,000 | 18,232,000 |
Common stock, shares outstanding | 20,100,000 | 18,232,000 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Operating expenses: | ||||
Research and development | $ 6,313 | $ 6,752 | $ 21,155 | $ 17,915 |
General and administrative | 2,319 | 2,198 | 7,575 | 6,776 |
Total operating expenses | 8,632 | 8,950 | 28,730 | 24,691 |
Loss from operations | (8,632) | (8,950) | (28,730) | (24,691) |
Interest income, net | 88 | 50 | 246 | 115 |
Net loss | $ (8,544) | $ (8,900) | $ (28,484) | $ (24,576) |
Net loss per share, basic and diluted | $ (0.44) | $ (0.49) | $ (1.50) | $ (1.36) |
Weighted average common shares used to compute net loss per share, basic and diluted | 19,507 | 18,105 | 18,963 | 18,005 |
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 Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (8,544) | $ (8,900) | $ (28,484) | $ (24,576) |
Other comprehensive loss: | ||||
Net unrealized gain (loss) on available-for-sale securities | (22) | 41 | 65 | |
Total comprehensive loss | $ (8,566) | $ (8,859) | $ (28,419) | $ (24,576) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Cash Flows From Operating Activities | ||
Net loss | $ (28,484) | $ (24,576) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 222 | 320 |
Amortization of premiums on investments | 485 | 268 |
Stock-based compensation | 3,187 | 2,260 |
Gain on disposal of property and equipment | (7) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 951 | 98 |
Other assets | 205 | |
Accounts payable | 703 | (128) |
Accrued liabilities | 381 | 1,851 |
Deferred rent, non-current | 98 | (105) |
Net cash used in operating activities | (22,252) | (20,019) |
Cash Flows From Investing Activities | ||
Purchases of investments | (35,811) | (88,846) |
Proceeds from sale or maturity of investments | 56,540 | 15,122 |
Purchase of property and equipment | (237) | (340) |
Net cash provided by (used in) investing activities | 20,492 | (74,064) |
Cash Flows From Financing Activities | ||
Proceeds from issuance of common stock through an at-the-market offering, net | 6,961 | |
Proceeds from stock option exercises and employee stock plan purchases | 294 | 545 |
Net cash provided by financing activities | 7,255 | 545 |
Net increase (decrease) in cash and cash equivalents | 5,495 | (93,538) |
Cash and cash equivalents at beginning of period | 6,105 | 101,969 |
Cash and cash equivalents at end of period | $ 11,600 | $ 8,431 |
Organization and Basis of Prese
Organization and Basis of Presentation | 9 Months Ended |
Sep. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Calithera Biosciences, Inc. (the “Company”) was incorporated in the State of Delaware on March 9, 2010. The Company is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. The Company’s principal operations are based in South San Francisco, California, and it operates in one segment. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Unaudited Interim Financial Information The interim condensed balance sheet as of September 30, 2016, and the statements of operations, comprehensive loss, and cash flows for the three and nine months ended September 30, 2016 and 2015 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed financial statements included in this report. The financial data and the other information disclosed in these notes to the financial statements related to the nine-month periods are also unaudited. The results of operations for the three and nine months ended September 30, 2016 are not necessarily indicative of the results to be expected for the year ending December 31, 2016 or for any other future annual or interim period. The balance sheet as of December 31, 2015 included herein was derived from the audited financial statements as of that date. These financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Form 10-K as filed with the Securities and Exchange Commission (“SEC”). Use of Estimates The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to preclinical, clinical trial and contract manufacturing accrued liabilities, fair value of common stock, income taxes, and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Investments All investments have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from net loss and are reported as a component of comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest income, net in the statement of operations. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest income, net. Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents, investments and restricted cash. The Company invests in a variety of financial instruments and, by its policy, limits these financial instruments to high credit quality securities issued by the U.S. government, U.S. government-sponsored agencies and highly rated banks and corporations, subject to certain concentration limits. The Company’s cash, cash equivalents, investments and restricted cash are held by financial institutions in the United States that management believes are of high credit quality. Amounts on deposit may at times exceed federally insured limits. Accrued Research and Development Costs The Company records accrued liabilities for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical and clinical studies, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced, and include these costs in accrued liabilities in the balance sheets and within research and development expense in the statements of operations. These costs are a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers under the service agreements. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. 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 without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. Recent Accounting Pronouncements In August 2014, the Financial Accounting Standards Board (the “FASB”), issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In February 2016, the FASB issued ASU 2016-02, Leases In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Fair value accounting is applied for all financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). Financial instruments include cash and cash equivalents, short-term investments, accounts payable and accrued liabilities. Cash equivalents and short-term investments are carried at estimated fair value and remeasured on a recurring basis. The carrying value of accounts payable and accrued liabilities approximate fair value due to the short-term nature of these maturities. Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1 —Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 —Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities 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 related assets or liabilities; and Level 3 —Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. 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 quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third party data providers, including but not limited to, benchmark yields, interest rate curves, reported trades, broker/dealer quotes and market reference data. The Company classifies its corporate notes and U.S. government agency securities as Level 2. Level 2 inputs for the valuations are limited to quoted prices for similar assets or liabilities in active markets and inputs other than quoted prices that are observable for the asset or liability. There were no transfers between Level 1 and Level 2 during the periods presented. The following table sets forth the fair value of our financial assets and liabilities, allocated into Level 1, Level 2 and Level 3, that was measured on a recurring basis (in thousands): September 30, 2016 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 8,554 $ - $ - $ 8,554 Corporate notes and commercial paper - 23,786 - 23,786 U.S. treasury securities - 3,007 - 3,007 U.S. government agency securities - 20,878 - 20,878 Total financial assets $ 8,554 $ 47,671 $ - $ 56,225 December 31, 2015 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 5,548 $ - $ - $ 5,548 Corporate notes and commercial paper - 23,151 - 23,151 U.S. treasury securities - 4,329 - 4,329 U.S. government agency securities - 38,340 - 38,340 Total financial assets $ 5,548 $ 65,820 $ - $ 71,368 |
Financial Instruments
Financial Instruments | 9 Months Ended |
Sep. 30, 2016 | |
Investments Debt And Equity Securities [Abstract] | |
Financial Instruments | 4. Financial Instruments Cash equivalents, short-term investments and long-term investments, all of which are classified as available-for-sale securities, and restricted cash consisted of the following (in thousands): September 30, 2016 December 31, 2015 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 8,554 $ - $ - $ 8,554 $ 5,548 $ - $ - $ 5,548 Corporate notes and commercial paper 23,798 - (12 ) 23,786 23,186 - (35 ) 23,151 U.S. treasury securities 3,005 2 - 3,007 4,334 - (5 ) 4,329 U.S. government agency securities 20,872 7 (1 ) 20,878 38,369 - (29 ) 38,340 $ 56,229 $ 9 $ (13 ) $ 56,225 $ 71,437 $ - $ (69 ) $ 71,368 Classified as: Cash equivalents $ 11,508 $ 5,502 Short-term investments 44,671 63,823 Long-term investments - 1,997 Restricted cash 46 46 Total $ 56,225 $ 71,368 At September 30, 2016, the remaining contractual maturities of available-for-sale securities were less than one year. There have been no significant realized gains or losses on available-for-sale securities for the periods presented. As of September 30, 2016, the Company had a total of $56.3 million in cash, cash equivalents, and investments, which includes $0.1 million in cash and $56.2 million in cash equivalents and investments. |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2016 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | 5. Accrued Liabilities Accrued liabilities consist of the following (in thousands): September 30, 2016 December 31, 2015 Accrued bonus and payroll expenses $ 1,755 $ 1,696 Accrued professional and consulting services 90 153 Accrued clinical and manufacturing expenses 1,358 921 Accrued preclinical and research expenses 125 194 Other 152 307 Total accrued liabilities $ 3,480 $ 3,271 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2016 | |
Equity [Abstract] | |
Stockholders' Equity | 6. Stockholders’ Equity At-the-Market Offering In November 2015, the Company entered into a sales agreement with Cowen and Company LLC (“Cowen”), as sales agent and underwriter, pursuant to which the Company may issue and sell shares of its common stock for an aggregate maximum offering price of $50.0 million under an at-the-market (“ATM”) offering program. The Company will pay Cowen up to 3% of gross proceeds for any common stock sold through the sales agreement. During the nine months ended September 30, 2016, the Company sold an aggregate of 1,750,681 shares of common stock pursuant to the ATM program, at an average price of approximately $4.48 per share for gross proceeds of $7.8 million, resulting in net proceeds of $7.2 million after deducting underwriting fees and offering expenses. As of September 30, 2016, $0.2 million was a receivable from sales under the ATM program and presented as a deduction from stockholders’ equity in the condensed balance sheets. As of September 30, 2016, $42.2 million of common stock remained available for sale under the ATM program. |
Stock Based Compensation
Stock Based Compensation | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Based Compensation | 7. Stock Based Compensation A summary of stock option activity is as follows (in thousands, except weighted average exercise price and contractual term amounts): Options Outstanding Number of Shares Underlying Outstanding Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Value Intrinsic Outstanding — December 31, 2015 1,665 $ 8.80 $ 3,831 Options granted 971 $ 4.72 Options exercised (67 ) $ 1.68 Options canceled (61 ) $ 6.94 Outstanding — September 30, 2016 2,508 $ 7.45 8.42 $ 597 Exercisable — September 30, 2016 785 $ 8.07 7.75 $ 380 Vested and expected to vest — September 30, 2016 2,463 $ 7.46 8.41 $ 595 Total stock-based compensation expense related to the Company’s 2010 Equity Incentive Plan, 2014 Equity Incentive Plan and the 2014 Employee Stock Purchase Plan was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ 475 $ 370 $ 1,391 $ 994 General and administrative 598 506 1,796 1,266 Total stock-based compensation $ 1,073 $ 876 $ 3,187 $ 2,260 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 8. Net Loss per Share Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. Potentially dilutive securities that were not included in the diluted per share attributable to common stockholders calculations because they would be anti-dilutive were as follows (in thousands): September 30, 2016 2015 Options to purchase common stock 2,508 1,740 Total 2,508 1,740 |
Licensing Agreements
Licensing Agreements | 9 Months Ended |
Sep. 30, 2016 | |
Licensing Agreements [Abstract] | |
Licensing Agreements | 9. Licensing Agreements Symbioscience License Agreement In December 2014, the Company entered into an exclusive license agreement with Mars, Inc., by and through its Mars Symbioscience division, or Symbioscience, under which the Company has been granted the exclusive, worldwide license to develop and commercialize Symbioscience’s portfolio of arginase inhibitors for use in human healthcare (“Symbioscience License Agreement”). Under the terms of the Symbioscience License Agreement, the Company paid Symbioscience an upfront license fee of $0.3 million in 2014, which was recorded in research and development expenses in the statement of operations. For the nine months ended September 30, 2016 and 2015, the Company made milestone payments of $0.6 million and $0.2 million, respectively, which were recorded in research and development expenses in the statement of operations. For the three months ended September 30, 2016 and 2015, the Company made milestone payments of $0.4 million and $0, respectively. The Company may make future payments of up to $23.6 million contingent upon attainment of various development and regulatory milestones and $95.0 million contingent upon attainment of various sales milestones. Additionally, the Company will pay royalties on sales of the licensed product, if such product sales are ever achieved. If the Company develops additional licensed products, after achieving regulatory approval of the first licensed product, the Company would owe additional regulatory milestone payments and additional royalty payments based on sales of such additional licensed products. vTv License Agreement In March 2015, the Company entered into a License and Research agreement with High Point Pharmaceuticals, LLC and TransTech Pharma LLC, or collectively TransTech, under which the Company obtained an exclusive, worldwide license to develop and commercialize TransTech’s hexokinase II inhibitors (“vTv License Agreement”). The agreement was subsequently assigned by TransTech to its parent company, vTv Therapeutics LLC (“vTv”). Under the terms of the vTv License Agreement, the Company paid an initial license fee of $0.6 million in 2015, which was recorded in research and development expense in the statement of operations. For the three and nine months ended September 30, 2015, the Company recognized expense of $0 million and $0.6 million, respectively, which was recorded in research and development expense in the statement of operations. There were no expenses recorded in the three and nine months ended September 30, 2016. The Company may pay potential development and regulatory milestone payments totaling up to $30.5 million for the first licensed product. vTv is eligible for an additional $77.0 million in potential sales-based milestones, as well as royalty payments, at mid-single digit royalty rates, based on tiered sales of the first commercialized licensed product. If the Company develops additional licensed products, after achieving regulatory approval of the first licensed product, the Company would owe additional regulatory milestone payments and additional royalty payments based on sales of such additional licensed products. The Company will be responsible for the worldwide development and commercialization of the licensed products, at its cost. |
Summary of Significant Accoun16
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The interim condensed balance sheet as of September 30, 2016, and the statements of operations, comprehensive loss, and cash flows for the three and nine months ended September 30, 2016 and 2015 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed financial statements included in this report. The financial data and the other information disclosed in these notes to the financial statements related to the nine-month periods are also unaudited. The results of operations for the three and nine months ended September 30, 2016 are not necessarily indicative of the results to be expected for the year ending December 31, 2016 or for any other future annual or interim period. The balance sheet as of December 31, 2015 included herein was derived from the audited financial statements as of that date. These financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Form 10-K as filed with the Securities and Exchange Commission (“SEC”). |
Use of Estimates | Use of Estimates The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to preclinical, clinical trial and contract manufacturing accrued liabilities, fair value of common stock, income taxes, and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. |
Investments | Investments All investments have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from net loss and are reported as a component of comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest income, net in the statement of operations. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest income, net. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents, investments and restricted cash. The Company invests in a variety of financial instruments and, by its policy, limits these financial instruments to high credit quality securities issued by the U.S. government, U.S. government-sponsored agencies and highly rated banks and corporations, subject to certain concentration limits. The Company’s cash, cash equivalents, investments and restricted cash are held by financial institutions in the United States that management believes are of high credit quality. Amounts on deposit may at times exceed federally insured limits. |
Accrued Research and Development Costs | Accrued Research and Development Costs The Company records accrued liabilities for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical and clinical studies, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced, and include these costs in accrued liabilities in the balance sheets and within research and development expense in the statements of operations. These costs are a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers under the service agreements. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. |
Net Loss per Share | 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 without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2014, the Financial Accounting Standards Board (the “FASB”), issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In February 2016, the FASB issued ASU 2016-02, Leases In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | The following table sets forth the fair value of our financial assets and liabilities, allocated into Level 1, Level 2 and Level 3, that was measured on a recurring basis (in thousands): September 30, 2016 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 8,554 $ - $ - $ 8,554 Corporate notes and commercial paper - 23,786 - 23,786 U.S. treasury securities - 3,007 - 3,007 U.S. government agency securities - 20,878 - 20,878 Total financial assets $ 8,554 $ 47,671 $ - $ 56,225 December 31, 2015 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 5,548 $ - $ - $ 5,548 Corporate notes and commercial paper - 23,151 - 23,151 U.S. treasury securities - 4,329 - 4,329 U.S. government agency securities - 38,340 - 38,340 Total financial assets $ 5,548 $ 65,820 $ - $ 71,368 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Investments Debt And Equity Securities [Abstract] | |
Available-for-Sale Securities | Cash equivalents, short-term investments and long-term investments, all of which are classified as available-for-sale securities, and restricted cash consisted of the following (in thousands): September 30, 2016 December 31, 2015 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 8,554 $ - $ - $ 8,554 $ 5,548 $ - $ - $ 5,548 Corporate notes and commercial paper 23,798 - (12 ) 23,786 23,186 - (35 ) 23,151 U.S. treasury securities 3,005 2 - 3,007 4,334 - (5 ) 4,329 U.S. government agency securities 20,872 7 (1 ) 20,878 38,369 - (29 ) 38,340 $ 56,229 $ 9 $ (13 ) $ 56,225 $ 71,437 $ - $ (69 ) $ 71,368 Classified as: Cash equivalents $ 11,508 $ 5,502 Short-term investments 44,671 63,823 Long-term investments - 1,997 Restricted cash 46 46 Total $ 56,225 $ 71,368 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Payables And Accruals [Abstract] | |
Summary of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): September 30, 2016 December 31, 2015 Accrued bonus and payroll expenses $ 1,755 $ 1,696 Accrued professional and consulting services 90 153 Accrued clinical and manufacturing expenses 1,358 921 Accrued preclinical and research expenses 125 194 Other 152 307 Total accrued liabilities $ 3,480 $ 3,271 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Stock Option Activity | A summary of stock option activity is as follows (in thousands, except weighted average exercise price and contractual term amounts): Options Outstanding Number of Shares Underlying Outstanding Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Value Intrinsic Outstanding — December 31, 2015 1,665 $ 8.80 $ 3,831 Options granted 971 $ 4.72 Options exercised (67 ) $ 1.68 Options canceled (61 ) $ 6.94 Outstanding — September 30, 2016 2,508 $ 7.45 8.42 $ 597 Exercisable — September 30, 2016 785 $ 8.07 7.75 $ 380 Vested and expected to vest — September 30, 2016 2,463 $ 7.46 8.41 $ 595 |
2010 Equity Incentive Plan, 2014 Equity Incentive Plan and 2014 Employee Stock Purchase Plan | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Stock Based Compensation Expense | Total stock-based compensation expense related to the Company’s 2010 Equity Incentive Plan, 2014 Equity Incentive Plan and the 2014 Employee Stock Purchase Plan was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ 475 $ 370 $ 1,391 $ 994 General and administrative 598 506 1,796 1,266 Total stock-based compensation $ 1,073 $ 876 $ 3,187 $ 2,260 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Common Stock Excluded from Calculation of Diluted Net Loss Per Share | Potentially dilutive securities that were not included in the diluted per share attributable to common stockholders calculations because they would be anti-dilutive were as follows (in thousands): September 30, 2016 2015 Options to purchase common stock 2,508 1,740 Total 2,508 1,740 |
Organization and Basis of Pre22
Organization and Basis of Presentation - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2016Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
State of incorporation | Delaware |
Date of incorporation | Mar. 9, 2010 |
Number of operating segments | 1 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Financial Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 56,225 | $ 71,368 |
Corporate notes and commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 23,786 | 23,151 |
Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 8,554 | 5,548 |
U.S. treasury securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 3,007 | 4,329 |
U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 20,878 | 38,340 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 8,554 | 5,548 |
Level 1 | Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 8,554 | 5,548 |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 47,671 | 65,820 |
Level 2 | Corporate notes and commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 23,786 | 23,151 |
Level 2 | U.S. treasury securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 3,007 | 4,329 |
Level 2 | U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 20,878 | $ 38,340 |
Financial Instruments - Availab
Financial Instruments - Available-for-sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | $ 56,229 | $ 71,437 |
Unrealized Gain | 9 | |
Unrealized (Loss) | (13) | (69) |
Estimated Fair Value | 56,225 | 71,368 |
Money market funds | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 8,554 | 5,548 |
Estimated Fair Value | 8,554 | 5,548 |
U.S. treasury securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 3,005 | 4,334 |
Unrealized Gain | 2 | |
Unrealized (Loss) | (5) | |
Estimated Fair Value | 3,007 | 4,329 |
U.S. government agency securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 20,872 | 38,369 |
Unrealized Gain | 7 | |
Unrealized (Loss) | (1) | (29) |
Estimated Fair Value | 20,878 | 38,340 |
Corporate notes and commercial paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 23,798 | 23,186 |
Unrealized (Loss) | (12) | (35) |
Estimated Fair Value | 23,786 | 23,151 |
Cash Equivalents | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | 11,508 | 5,502 |
Short-term Investments | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | 44,671 | 63,823 |
Long-term investments | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | 1,997 | |
Restricted Cash | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | $ 46 | $ 46 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Investments Debt And Equity Securities [Abstract] | |
Remaining contractual maturities of available-for-sale-securities | less than one year |
Realized gains (losses) on available-for-sale securities | $ 0 |
Cash, cash equivalents, and investments | 56,300,000 |
Cash portion included in cash, cash equivalents and investments | 100,000 |
Cash equivalents and investments | $ 56,200,000 |
Accrued Liabilities - Summary o
Accrued Liabilities - Summary of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Payables And Accruals [Abstract] | ||
Accrued bonus and payroll expenses | $ 1,755 | $ 1,696 |
Accrued professional and consulting services | 90 | 153 |
Accrued clinical and manufacturing expenses | 1,358 | 921 |
Accrued preclinical and research expenses | 125 | 194 |
Other | 152 | 307 |
Total accrued liabilities | $ 3,480 | $ 3,271 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | 1 Months Ended | 9 Months Ended |
Nov. 30, 2015 | Sep. 30, 2016 | |
Class Of Stock [Line Items] | ||
Net proceeds from sale of common stock | $ 6,961,000 | |
Receivable from sales under program | 247,000 | |
At-the-Market Offering | Cowen and Company LLC | ||
Class Of Stock [Line Items] | ||
Gross proceeds from sale of common stock | 7,800,000 | |
Net proceeds from sale of common stock | 7,200,000 | |
Receivable from sales under program | 200,000 | |
Common stock value remained available for sale | $ 42,200,000 | |
At-the-Market Offering | Common Stock | Cowen and Company LLC | ||
Class Of Stock [Line Items] | ||
Aggregate maximum offering price | $ 50,000,000 | |
Number of shares sold | 1,750,681 | |
Shares sold, average price per share | $ 4.48 | |
Maximum | At-the-Market Offering | Common Stock | Cowen and Company LLC | ||
Class Of Stock [Line Items] | ||
Percentage of sales commission on gross proceeds for common stock sold through sales agreement | 3.00% |
Stock Based Compensation - Summ
Stock Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Dec. 31, 2015 | |
Number of Shares Underlying Outstanding Options | ||
Outstanding at Beginning balance | 1,665,000 | |
Options granted | 971,000 | |
Options exercised | (67,000) | |
Options canceled | (61,000) | |
Outstanding at Ending balance | 2,508,000 | |
Exercisable at End of Period | 785,000 | |
Vested and expected to vest at End of Period | 2,463,000 | |
Weighted-Average Exercise Price | ||
Outstanding at Beginning balance | $ 8.80 | |
Options granted | 4.72 | |
Options exercised | 1.68 | |
Options canceled | 6.94 | |
Outstanding at Ending balance | 7.45 | |
Exercisable at End of Period | 8.07 | |
Vested and expected to vest at End of Period | $ 7.46 | |
Weighted Average Remaining Contractual Term (Years) | ||
Outstanding at Ending balance | 8 years 5 months 1 day | |
Exercisable at End of Period | 7 years 9 months | |
Vested and expected to vest at End of Period | 8 years 4 months 28 days | |
Aggregate Value Intrinsic | ||
Outstanding | $ 597 | $ 3,831 |
Exercisable at End of Period | 380 | |
Vested and expected to vest at End of Period | $ 595 |
Stock Based Compensation - Su29
Stock Based Compensation - Summary of Stock-based Compensation Expense (Details) - 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 [Line Items] | ||||
Stock-based compensation | $ 3,187 | $ 2,260 | ||
2010 Equity Incentive Plan, 2014 Equity Incentive Plan and 2014 Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation | $ 1,073 | $ 876 | 3,187 | 2,260 |
2010 Equity Incentive Plan, 2014 Equity Incentive Plan and 2014 Employee Stock Purchase Plan | Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation | 475 | 370 | 1,391 | 994 |
2010 Equity Incentive Plan, 2014 Equity Incentive Plan and 2014 Employee Stock Purchase Plan | General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation | $ 598 | $ 506 | $ 1,796 | $ 1,266 |
Net Loss Per Share - Common Sto
Net Loss Per Share - Common Stock Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 2,508 | 1,740 |
Options to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 2,508 | 1,740 |
Licensing Agreements - Addition
Licensing Agreements - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2016 | Sep. 30, 2015 | Mar. 31, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Mars, Inc. | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Potential license agreement fee | $ 23,600,000 | ||||||
Additional potential payments based on sale of first licensed product | 95,000,000 | ||||||
Mars, Inc. | Research and Development | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Initial license fee | $ 300,000 | ||||||
Recognized on milestone payments | $ 400,000 | $ 0 | $ 600,000 | $ 200,000 | |||
vTv Therapeutics LLC | vTv License Agreement | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Potential license agreement fee | $ 30,500,000 | ||||||
Additional potential payments based on sale of first licensed product | $ 77,000,000 | ||||||
vTv Therapeutics LLC | Research and Development | vTv License Agreement | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Initial license fee | $ 0 | $ 0 | $ 0 | $ 600,000 | $ 600,000 |