Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | Apr. 30, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 31-Mar-15 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CALA | |
Entity Registrant Name | Calithera Biosciences, Inc. | |
Entity Central Index Key | 1496671 | |
Current Fiscal Year End Date | -19 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 17,946,393 |
Condensed_Balance_Sheets
Condensed Balance Sheets (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $73,877 | $101,969 |
Short-term investments | 14,705 | |
Prepaid expenses and other current assets | 1,728 | 1,894 |
Total current assets | 90,310 | 103,863 |
Long-term investments | 5,693 | |
Restricted cash | 46 | 46 |
Property and equipment, net | 824 | 861 |
Total assets | 96,873 | 104,770 |
Current liabilities: | ||
Accounts payable | 559 | 693 |
Accrued liabilities | 2,962 | 3,428 |
Total current liabilities | 3,521 | 4,121 |
Deferred rent | 235 | 270 |
Other non-current liabilities | 13 | 13 |
Total liabilities | 3,769 | 4,404 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity (deficit): | ||
Common stock, $0.0001 par value, 200,000 shares authorized as of March 31, 2015 (unaudited) and December 31, 2014; 17,946 and 17,943 shares issued and outstanding as of March 31, 2015 (unaudited) and December 31, 2014, respectively | 2 | 2 |
Additional paid-in capital | 152,820 | 152,218 |
Accumulated deficit | -59,712 | -51,854 |
Accumulated other comprehensive loss | -6 | |
Total stockholders’ deficit | 93,104 | 100,366 |
Total liabilities and stockholders’ deficit | $96,873 | $104,770 |
Condensed_Balance_Sheets_Paren
Condensed Balance Sheets (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 17,946,000 | 17,943,000 |
Common stock, shares outstanding | 17,946,000 | 17,943,000 |
Condensed_Statements_of_Operat
Condensed Statements of Operations (USD $) | 3 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Operating expenses: | ||
Research and development | $5,630 | $3,318 |
General and administrative | 2,237 | 832 |
Total operating expenses | 7,867 | 4,150 |
Loss from operations | -7,867 | -4,150 |
Other income, net | 9 | 1 |
Net loss | ($7,858) | ($4,149) |
Net loss per share attributable to common stockholders, basic and diluted | ($0.44) | ($22.80) |
Weighted average common shares used to compute net loss per share attributable to common stockholders, basic and diluted | 17,946 | 182 |
Condensed_Statements_of_Compre
Condensed Statements of Comprehensive Loss (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | ($7,858) | ($4,149) |
Other comprehensive loss: | ||
Net unrealized losses on available-for-sale securities | -6 | |
Total comprehensive loss | ($7,864) | ($4,149) |
Condensed_Statements_of_Cash_F
Condensed Statements of Cash Flows (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Cash Flows From Operating Activities | ||
Net loss | ($7,858) | ($4,149) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 109 | 73 |
Amortization of premium on investments | 2 | |
Stock-based compensation | 595 | 78 |
(Gain) loss on disposal of property and equipment | -8 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 166 | -323 |
Accounts payable | -134 | 24 |
Accrued liabilities | -466 | -291 |
Deferred rent, non-current | -35 | 66 |
Net cash used in operating activities | -7,629 | -4,522 |
Cash Flows From Investing Activities | ||
Purchases of investments | -20,406 | |
Purchase of property and equipment | -64 | -60 |
Net cash used in investing activities | -20,470 | -60 |
Cash Flows From Financing Activities | ||
Proceeds from stock option exercises | 7 | 17 |
Net cash provided by financing activities | 7 | 17 |
Net increase (decrease) in cash and cash equivalents | -28,092 | -4,565 |
Cash and cash equivalents at beginning of period | 101,969 | 33,820 |
Cash and cash equivalents at end of period | $73,877 | $29,255 |
Organization_and_Basis_of_Pres
Organization and Basis of Presentation | 3 Months Ended |
Mar. 31, 2015 | |
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. | |
Initial Public Offering | |
In October 2014, the Company completed an initial public offering (“IPO”) of its common stock. In connection with its IPO, the Company issued and sold 8,000,000 shares of its common stock, at a price to the public of $10.00 per share. As a result of the IPO, the Company received $71.6 million in net proceeds, after deducting underwriting discounts and commissions of $5.6 million and offering expenses of $2.8 million paid by the Company. At the closing of the IPO, 9,592,042 shares of outstanding convertible preferred stock were automatically converted into 9,592,042 shares of common stock. Following the IPO, there were no shares of preferred stock outstanding. In connection with the IPO, the Company amended and restated its Amended and Restated Certificate of Incorporation to change the authorized capital stock to 200,000,000 shares designated as common stock and 10,000,000 shares designated as preferred stock, all with a par value of $0.0001 per share. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2015 | |
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 March 31, 2015, and the statements of operations, comprehensive loss, and cash flows for the three months ended March 31, 2015 and 2014 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 three-month periods are also unaudited. The results of operations for the three months ended March 31, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other future annual or interim period. The balance sheet as of December 31, 2014 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 clinical trial 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 in at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from earnings 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 other income, net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in other 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 Attributable to Common Stockholders | |
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders 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, basic net loss per share attributable to common stockholders is the same as diluted net loss per share attributable to common stockholders for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. | |
Recent Accounting Pronouncements | |
In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU 2014-15 requires management to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. In doing so, companies will have reduced diversity in the timing and content of footnote disclosures than under today’s guidance. ASU 2014-15 is effective for the Company in the first quarter of 2016 with early adoption permitted. Management is currently assessing the impact the adoption of ASU 2014-15 will have on the financial statements. |
Fair_Value_Measurements
Fair Value Measurements | 3 Months Ended | |||||||||||||||||||||
Mar. 31, 2015 | ||||||||||||||||||||||
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 that approximate fair value due to their relatively short 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): | ||||||||||||||||||||||
March 31, 2015 | ||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Financial Assets: | ||||||||||||||||||||||
Money market funds | $ | 70,474 | $ | - | $ | - | $ | 70,474 | ||||||||||||||
Corporate notes | - | 13,028 | - | 13,028 | ||||||||||||||||||
U.S. government agency securities | - | 10,819 | - | 10,819 | ||||||||||||||||||
Total financial assets | $ | 70,474 | $ | 23,847 | $ | - | $ | 94,321 | ||||||||||||||
31-Dec-14 | ||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Financial Assets: | ||||||||||||||||||||||
Money market funds | $ | 102,015 | $ | - | $ | - | $ | 102,015 | ||||||||||||||
Total financial assets | $ | 102,015 | $ | - | $ | - | $ | 102,015 | ||||||||||||||
As of March 31, 2015 and December 31, 2014, the Company had $46,000 in money market funds that are included in restricted cash on the balance sheets. |
Financial_Instruments
Financial Instruments | 3 Months Ended | ||||||||||||||||||||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||||||||||||||||||||
Investments Debt And Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||
Financial Instruments | 4. Financial Instruments | ||||||||||||||||||||||||||||||||||
Cash equivalents and short-term and long-term investments, all of which are classified as available-for-sale securities, consisted of the following (in thousands): | |||||||||||||||||||||||||||||||||||
31-Mar-15 | 31-Dec-14 | ||||||||||||||||||||||||||||||||||
Cost | Unrealized Gain | Unrealized (Loss) | Estimated Fair Value | Cost | Unrealized Gain | Unrealized (Loss) | Estimated Fair Value | ||||||||||||||||||||||||||||
Money market funds | $ | 70,474 | $ | - | $ | - | $ | 70,474 | $ | 102,015 | $ | - | $ | - | $ | 102,015 | |||||||||||||||||||
Corporate notes | 13,034 | 1 | (7 | ) | 13,028 | - | - | - | - | ||||||||||||||||||||||||||
U.S. government agency securities | 10,819 | 1 | (1 | ) | 10,819 | - | - | - | - | ||||||||||||||||||||||||||
$ | 94,327 | $ | 2 | $ | (8 | ) | $ | 94,321 | $ | 102,015 | $ | - | $ | - | $ | 102,015 | |||||||||||||||||||
Classified as: | |||||||||||||||||||||||||||||||||||
Cash equivalents | $ | 73,923 | $ | 102,015 | |||||||||||||||||||||||||||||||
Short-term investments | 14,705 | - | |||||||||||||||||||||||||||||||||
Long-term investments | 5,693 | - | |||||||||||||||||||||||||||||||||
Total cash equivalents and investments | $ | 94,321 | $ | 102,015 | |||||||||||||||||||||||||||||||
At March 31, 2015, the remaining contractual maturities of available-for-sale securities were less than two years. There have been no significant realized gains or losses on available-for-sale securities for the periods presented. |
Accrued_Liabilities
Accrued Liabilities | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Payables And Accruals [Abstract] | ||||||||
Accrued Liabilities | 5. Accrued Liabilities | |||||||
Accrued liabilities consist of the following (in thousands): | ||||||||
31-Mar-15 | 31-Dec-14 | |||||||
Accrued bonus and payroll expenses | $ | 911 | $ | 1,476 | ||||
Accrued professional and consulting services | 169 | 490 | ||||||
Accrued clinical and manufacturing expenses | 1,059 | 1,029 | ||||||
Accrued licensing fee | 600 | - | ||||||
Other | 223 | 433 | ||||||
Total accrued liabilities | $ | 2,962 | $ | 3,428 | ||||
Commitment_and_Contingencies
Commitment and Contingencies | 3 Months Ended |
Mar. 31, 2015 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies |
In October 2014, the Company received an invoice of approximately $1.3 million relating to a contingent amount associated with a terminated license agreement, incurred as a result of the closing of its IPO in October 2014. The Company believes that the invoice amount is substantially in excess of the amount actually owed pursuant to the agreement and has initiated discussions with the third party to resolve the matter. The Company does not believe that the ultimate resolution of this matter will be material to the Company’s results of operations, financial condition or cash flows. |
Stock_Based_Compensation
Stock Based Compensation | 3 Months Ended | |||||||||||||||
Mar. 31, 2015 | ||||||||||||||||
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 share data and contractual term amounts): | ||||||||||||||||
Options Outstanding | ||||||||||||||||
Number of | Weighted- | Weighted- | Aggregate | |||||||||||||
Shares Underlying | Average | Average | Value | |||||||||||||
Outstanding | Exercise | Remaining | Intrinsic | |||||||||||||
Options | Price | Contractual | ||||||||||||||
Term | ||||||||||||||||
(Years) | ||||||||||||||||
Outstanding — December 31, 2014 | 1,210,920 | $ | 3.44 | $ | 20,292 | |||||||||||
Options granted | 620,099 | $ | 16.87 | |||||||||||||
Options exercised | (3,008 | ) | $ | 1.95 | ||||||||||||
Options canceled | (12,287 | ) | $ | 5.01 | ||||||||||||
Outstanding — March 31, 2015 | 1,815,724 | $ | 8.02 | 9.1 | $ | 15,553 | ||||||||||
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 March 31, | ||||||||||||||||
2015 | 2014 | |||||||||||||||
Research and development | $ | 270 | $ | 48 | ||||||||||||
General and administrative | 325 | 30 | ||||||||||||||
Total stock-based compensation | $ | 595 | $ | 78 | ||||||||||||
Net_Loss_Per_Share_Attributabl
Net Loss Per Share Attributable to Common Stockholders | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Earnings Per Share [Abstract] | ||||||||
Net Loss Per Share Attributable to Common Stockholders | 8. Net Loss per Share Attributable to Common Stockholders | |||||||
Since the Company was in a loss position for all periods presented, basic net loss per share attributable to common stockholders is the same as diluted net loss per share attributable to common stockholders 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): | ||||||||
March 31, | ||||||||
2015 | 2014 | |||||||
Convertible preferred stock | - | 7,689 | ||||||
Options to purchase common stock | 1,816 | 880 | ||||||
Common stock subject to repurchase | - | 1 | ||||||
Total | 1,816 | 8,570 | ||||||
Licensing_Agreements
Licensing Agreements | 3 Months Ended |
Mar. 31, 2015 | |
Licensing Agreements [Abstract] | |
Licensing Agreements | 9. Licensing Agreements |
TransTech 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 (TransTech License Agreement). Under the terms of the TransTech License Agreement, the Company will pay TransTech an initial license fee of $0.6 million, and potential development and regulatory milestone payments totaling up to $30.5 million for the first licensed product. TransTech 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. For the three months ended March 31, 2015, the Company recognized expense of $0.6 million related to its licensing arrangements with TransTech, in research and development expense in the statements of operations. | |
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 rights 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, which was recorded as research and development expense in 2014. The Company may make future payments of up to $24.4 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 royalty 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. |
Related_Party_Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2015 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 10. Related Party Transactions |
The spouse of one of the Company’s executive officers was a consultant who provided accounting services for the Company in 2014. For the three months ended March 31, 2015 and 2014, the Company recognized expense of $nil and $45,000, respectively, for consulting services within the general and administrative expense in the statements of operations. As of March 31, 2015 and December 31, 2014, the Company had an outstanding liability to the spouse of nil. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2015 | |
Accounting Policies [Abstract] | |
Unaudited Interim Financial Information | Unaudited Interim Financial Information |
The interim condensed balance sheet as of March 31, 2015, and the statements of operations, comprehensive loss, and cash flows for the three months ended March 31, 2015 and 2014 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 three-month periods are also unaudited. The results of operations for the three months ended March 31, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other future annual or interim period. The balance sheet as of December 31, 2014 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 clinical trial 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 in at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from earnings 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 other income, net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in other 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 Attributable to Common Stockholders | Net Loss per Share Attributable to Common Stockholders |
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders 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, basic net loss per share attributable to common stockholders is the same as diluted net loss per share attributable to common stockholders 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 FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU 2014-15 requires management to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. In doing so, companies will have reduced diversity in the timing and content of footnote disclosures than under today’s guidance. ASU 2014-15 is effective for the Company in the first quarter of 2016 with early adoption permitted. Management is currently assessing the impact the adoption of ASU 2014-15 will have on the financial statements. |
Fair_Value_Measurement_Table
Fair Value Measurement (Table) | 3 Months Ended | |||||||||||||||||||||
Mar. 31, 2015 | ||||||||||||||||||||||
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): | |||||||||||||||||||||
March 31, 2015 | ||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Financial Assets: | ||||||||||||||||||||||
Money market funds | $ | 70,474 | $ | - | $ | - | $ | 70,474 | ||||||||||||||
Corporate notes | - | 13,028 | - | 13,028 | ||||||||||||||||||
U.S. government agency securities | - | 10,819 | - | 10,819 | ||||||||||||||||||
Total financial assets | $ | 70,474 | $ | 23,847 | $ | - | $ | 94,321 | ||||||||||||||
31-Dec-14 | ||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Financial Assets: | ||||||||||||||||||||||
Money market funds | $ | 102,015 | $ | - | $ | - | $ | 102,015 | ||||||||||||||
Total financial assets | $ | 102,015 | $ | - | $ | - | $ | 102,015 | ||||||||||||||
Financial_Instruments_Tables
Financial Instruments (Tables) | 3 Months Ended | ||||||||||||||||||||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||||||||||||||||||||
Investments Debt And Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||
Available-for-Sale Securities | Cash equivalents and short-term and long-term investments, all of which are classified as available-for-sale securities, consisted of the following (in thousands): | ||||||||||||||||||||||||||||||||||
31-Mar-15 | 31-Dec-14 | ||||||||||||||||||||||||||||||||||
Cost | Unrealized Gain | Unrealized (Loss) | Estimated Fair Value | Cost | Unrealized Gain | Unrealized (Loss) | Estimated Fair Value | ||||||||||||||||||||||||||||
Money market funds | $ | 70,474 | $ | - | $ | - | $ | 70,474 | $ | 102,015 | $ | - | $ | - | $ | 102,015 | |||||||||||||||||||
Corporate notes | 13,034 | 1 | (7 | ) | 13,028 | - | - | - | - | ||||||||||||||||||||||||||
U.S. government agency securities | 10,819 | 1 | (1 | ) | 10,819 | - | - | - | - | ||||||||||||||||||||||||||
$ | 94,327 | $ | 2 | $ | (8 | ) | $ | 94,321 | $ | 102,015 | $ | - | $ | - | $ | 102,015 | |||||||||||||||||||
Classified as: | |||||||||||||||||||||||||||||||||||
Cash equivalents | $ | 73,923 | $ | 102,015 | |||||||||||||||||||||||||||||||
Short-term investments | 14,705 | - | |||||||||||||||||||||||||||||||||
Long-term investments | 5,693 | - | |||||||||||||||||||||||||||||||||
Total cash equivalents and investments | $ | 94,321 | $ | 102,015 | |||||||||||||||||||||||||||||||
Accrued_Liabilities_Tables
Accrued Liabilities (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Payables And Accruals [Abstract] | ||||||||
Summary of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): | |||||||
31-Mar-15 | 31-Dec-14 | |||||||
Accrued bonus and payroll expenses | $ | 911 | $ | 1,476 | ||||
Accrued professional and consulting services | 169 | 490 | ||||||
Accrued clinical and manufacturing expenses | 1,059 | 1,029 | ||||||
Accrued licensing fee | 600 | - | ||||||
Other | 223 | 433 | ||||||
Total accrued liabilities | $ | 2,962 | $ | 3,428 | ||||
Stock_Based_Compensation_Table
Stock Based Compensation (Tables) | 3 Months Ended | |||||||||||||||
Mar. 31, 2015 | ||||||||||||||||
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 share data and contractual term amounts): | |||||||||||||||
Options Outstanding | ||||||||||||||||
Number of | Weighted- | Weighted- | Aggregate | |||||||||||||
Shares Underlying | Average | Average | Value | |||||||||||||
Outstanding | Exercise | Remaining | Intrinsic | |||||||||||||
Options | Price | Contractual | ||||||||||||||
Term | ||||||||||||||||
(Years) | ||||||||||||||||
Outstanding — December 31, 2014 | 1,210,920 | $ | 3.44 | $ | 20,292 | |||||||||||
Options granted | 620,099 | $ | 16.87 | |||||||||||||
Options exercised | (3,008 | ) | $ | 1.95 | ||||||||||||
Options canceled | (12,287 | ) | $ | 5.01 | ||||||||||||
Outstanding — March 31, 2015 | 1,815,724 | $ | 8.02 | 9.1 | $ | 15,553 | ||||||||||
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 March 31, | ||||||||||||||||
2015 | 2014 | |||||||||||||||
Research and development | $ | 270 | $ | 48 | ||||||||||||
General and administrative | 325 | 30 | ||||||||||||||
Total stock-based compensation | $ | 595 | $ | 78 | ||||||||||||
Net_Loss_Per_Share_Attributabl1
Net Loss Per Share Attributable to Common Stockholders (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
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): | |||||||
March 31, | ||||||||
2015 | 2014 | |||||||
Convertible preferred stock | - | 7,689 | ||||||
Options to purchase common stock | 1,816 | 880 | ||||||
Common stock subject to repurchase | - | 1 | ||||||
Total | 1,816 | 8,570 | ||||||
Organization_and_Basis_of_Pres1
Organization and Basis of Presentation - Additional Information (Details) (USD $) | 3 Months Ended | 0 Months Ended | |
In Millions, except Share data, unless otherwise specified | Mar. 31, 2015 | Oct. 07, 2014 | Dec. 31, 2014 |
Segment | |||
Basis Of Presentation [Line Items] | |||
State of incorporation | Delaware | ||
Date of incorporation | 9-Mar-10 | ||
Number of operating segments | 1 | ||
Common stock, shares outstanding | 17,946,000 | 17,943,000 | |
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 |
Preferred stock, shares authorized | 10,000,000 | ||
Common stock, par value | $0.00 | $0.00 | $0.00 |
Preferred stock, par value | $0.00 | ||
Initial Public Offering | |||
Basis Of Presentation [Line Items] | |||
Preferred stock, shares outstanding | 0 | ||
Common stock, shares outstanding | 9,592,042 | ||
Initial Public Offering | Convertible Preferred Stock | |||
Basis Of Presentation [Line Items] | |||
Preferred stock, shares outstanding | 9,592,042 | ||
Initial Public Offering | Common Stock | |||
Basis Of Presentation [Line Items] | |||
Number of shares issued | 8,000,000 | ||
Public offering price | $10 | ||
Net proceeds from the IPO | $71.60 | ||
Underwriting discounts and commissions | 5.6 | ||
Offering expenses | $2.80 |
Fair_Value_Measurements_Fair_V
Fair Value Measurements - Fair Value of Financial Assets and Liabilities (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $94,321 | $102,015 |
Corporate notes | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 13,028 | |
Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 70,474 | 102,015 |
U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 10,819 | |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 70,474 | 102,015 |
Level 1 | Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 70,474 | 102,015 |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 23,847 | |
Level 2 | Corporate notes | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 13,028 | |
Level 2 | U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $10,819 |
Fair_Value_Measurements_Additi
Fair Value Measurements - Additional Information (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Fair Value Disclosures [Abstract] | ||
Restricted cash | $46 | $46 |
Financial_Instruments_Availabl
Financial Instruments - Available-for-sale Securities (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | $94,327 | $102,015 |
Unrealized Gain | 2 | |
Unrealized (Loss) | -8 | |
Estimated Fair Value | 94,321 | 102,015 |
Money market funds | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 70,474 | 102,015 |
Estimated Fair Value | 70,474 | 102,015 |
U.S. government agency securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 10,819 | |
Unrealized Gain | 1 | |
Unrealized (Loss) | -1 | |
Estimated Fair Value | 10,819 | |
Cash Equivalents | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | 73,923 | 102,015 |
Short-term Investments | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | 14,705 | |
Long-term Investments | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | 5,693 | |
Corporate notes | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 13,034 | |
Unrealized Gain | 1 | |
Unrealized (Loss) | -7 | |
Estimated Fair Value | $13,028 |
Financial_Instruments_Addition
Financial Instruments - Additional Information (Details) (USD $) | 3 Months Ended |
Mar. 31, 2015 | |
Investments Debt And Equity Securities [Abstract] | |
Remaining contractual maturities of available-for-sale-securities | less than two years |
Realized gains (losses) on available-for-sale securities | $0 |
Accrued_Liabilities_Summary_of
Accrued Liabilities - Summary of Accrued Liabilities (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Payables And Accruals [Abstract] | ||
Accrued bonus and payroll expenses | $911 | $1,476 |
Accrued professional and consulting services | 169 | 490 |
Accrued clinical and manufacturing expenses | 1,059 | 1,029 |
Accrued licensing fee | 600 | |
Other | 223 | 433 |
Total accrued liabilities | $2,962 | $3,428 |
Commitment_and_Contingencies_A
Commitment and Contingencies - Additional Information (Details) (USD $) | Oct. 31, 2014 |
In Millions, unless otherwise specified | |
Commitments And Contingencies Disclosure [Abstract] | |
Contingent amount associated with terminated license agreement | $1.30 |
Stock_Based_Compensation_Summa
Stock Based Compensation - Summary of Stock Option Activity (Details) (USD $) | 3 Months Ended |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 |
Number of Shares Underlying Outstanding Options | |
Outstanding at Beginning balance | 1,210,920 |
Options granted | 620,099 |
Options exercised | -3,008 |
Options canceled | -12,287 |
Outstanding at Ending balance | 1,815,724 |
Weighted-Average Exercise Price | |
Outstanding at Beginning balance | $3.44 |
Options granted | $16.87 |
Options exercised | $1.95 |
Options canceled | $5.01 |
Outstanding at Ending balance | $8.02 |
Weighted Average Remaining Contractual Term (Years) | |
Outstanding at Ending balance | 9 years 1 month 6 days |
Aggregate Value Intrinsic | |
Outstanding at Beginning of Period | $20,292 |
Outstanding at End of Period | $15,553 |
Stock_Based_Compensation_Summa1
Stock Based Compensation - Summary of Stock-based Compensation Expense (Details) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | $595 | $78 |
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 | 595 | 78 |
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 | 270 | 48 |
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 | $325 | $30 |
Net_Loss_Per_Share_Attributabl2
Net Loss Per Share Attributable to Common Stockholders - Common Stock Excluded from Calculation of Diluted Net Loss Per Share (Details) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,816 | 8,570 |
Convertible Preferred Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 7,689 | |
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 | 1,816 | 880 |
Common stock subject to repurchase | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1 |
Licensing_Agreements_Additiona
Licensing Agreements - Additional Information (Details) (USD $) | 12 Months Ended | 3 Months Ended |
In Millions, unless otherwise specified | Dec. 31, 2014 | Mar. 31, 2015 |
Mars, Inc. | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
License agreement fee | $24.40 | |
Additional potential payments based on sale of first licensed product | 95 | |
Mars, Inc. | Research and Development | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Initial license fee | 0.3 | |
TransTech License Agreement | High Point Pharmaceuticals L L C And Trans Tech Pharma L L C | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Initial license fee | 0.6 | |
License agreement fee | 30.5 | |
Additional potential payments based on sale of first licensed product | 77 | |
TransTech License Agreement | High Point Pharmaceuticals L L C And Trans Tech Pharma L L C | Research and Development | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Initial license fee | $0.60 |
Related_Party_Transactions_Add
Related Party Transactions - Additional Information (Details) (USD $) | 3 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2014 | |
Related Party Transaction [Line Items] | |||
General and administrative | $2,237,000 | $832,000 | |
Outstanding professional liability | 169,000 | 490,000 | |
Consulting Services | |||
Related Party Transaction [Line Items] | |||
General and administrative | 0 | 45,000 | |
Outstanding professional liability | $0 | $0 |