Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Jul. 31, 2015 | |
Document and Entity Information | ||
Entity Registrant Name | Loxo Oncology, Inc. | |
Entity Central Index Key | 1,581,720 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 16,687,436 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 36,635 | $ 43,930 |
Short-term investments | 65,165 | 62,362 |
Prepaid expenses with related party | 972 | 663 |
Other prepaid expenses and current assets | 410 | 821 |
Total current assets | 103,182 | 107,776 |
Long-term investments | 6,648 | |
Property and equipment, net | 78 | 12 |
Security deposit | 23 | 23 |
Total assets | 103,283 | 114,459 |
Current liabilities: | ||
Accounts payable | 415 | 239 |
Accrued expenses and other current liabilities | 1,403 | 1,548 |
Total liabilities | $ 1,818 | $ 1,787 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.0001 par value; 125,000,000 shares authorized; 16,687,436 shares issued and outstanding at June 30, 2015; 16,644,219 shares issued and 16,634,063 shares outstanding at December 31, 2014 | $ 2 | $ 2 |
Additional paid-in capital | 146,660 | 143,660 |
Accumulated deficit | (45,200) | (30,962) |
Accumulated other comprehensive income (loss) | 3 | (28) |
Total stockholders' equity | 101,465 | 112,672 |
Total liabilities and stockholders' equity | $ 103,283 | $ 114,459 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
Condensed Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 16,687,436 | 16,644,219 |
Common stock, shares outstanding | 16,687,436 | 16,634,063 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Operating expenses: | ||||
Research and development with related party | $ 2,919 | $ 1,717 | $ 4,837 | $ 2,992 |
Research and development | 2,793 | 1,020 | 4,708 | 1,789 |
General and administrative | 2,387 | 1,168 | 4,779 | 2,026 |
Total operating expenses and loss from operations | (8,099) | (3,905) | (14,324) | (6,807) |
Interest income, net | 43 | 86 | ||
Net loss | (8,056) | (3,905) | (14,238) | (6,807) |
Accretion of redeemable convertible preferred stock | (17) | (28) | ||
Net loss attributable to common stockholders | $ (8,056) | $ (3,922) | $ (14,238) | $ (6,835) |
Share information: | ||||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.49) | $ (14.46) | $ (0.86) | $ (28.69) |
Weighted average shares outstanding, basic and diluted | 16,540,764 | 271,317 | 16,507,700 | 238,246 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Statement of Comprehensive Income | ||||
Net loss | $ (8,056) | $ (3,905) | $ (14,238) | $ (6,807) |
Other comprehensive income: | ||||
Unrealized gain on available for sale securities | 10 | 31 | ||
Comprehensive loss | $ (8,046) | $ (3,905) | $ (14,207) | $ (6,807) |
Condensed Statement of Stockhol
Condensed Statement of Stockholders' Equity - 6 months ended Jun. 30, 2015 - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total |
Balance at Dec. 31, 2014 | $ 2 | $ 143,660 | $ (30,962) | $ (28) | $ 112,672 |
Balance (in shares) at Dec. 31, 2014 | 16,634,063 | ||||
Changes in Stockholders' Equity | |||||
Stock-based compensation expense | 2,684 | 2,684 | |||
Stock options exercises | 279 | 279 | |||
Stock option exercises (in shares) | 43,217 | ||||
Reclassification of shares issued and previously subject to repurchase | 37 | 37 | |||
Reclassification of shares issued and previously subject to repurchase (in shares) | 10,156 | ||||
Other comprehensive income | 31 | 31 | |||
Net loss | (14,238) | (14,238) | |||
Balance at Jun. 30, 2015 | $ 2 | $ 146,660 | $ (45,200) | $ 3 | $ 101,465 |
Balance (in shares) at Jun. 30, 2015 | 16,687,436 |
Condensed Statement of Stockho7
Condensed Statement of Stockholders' Equity (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
Condensed Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Operating activities: | ||
Net loss | $ (14,238) | $ (6,807) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization of premium and discounts on investments, net | 157 | |
Stock-based compensation | 2,684 | 537 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 102 | (646) |
Accounts payable | 176 | 355 |
Accrued expenses and other current liabilities | (108) | 118 |
Net cash used in operating activities | (11,227) | (6,443) |
Investing activities: | ||
Purchases of available-for-sale securities | (36,676) | |
Proceeds from maturing available-for-sale securities | 40,400 | |
Purchase of property, plant and equipment | (71) | (7) |
Net cash provided by (used in) investing activities | 3,653 | (7) |
Financing activities: | ||
Proceeds from issuance of redeemable convertible preferred stock, net | 43,223 | |
Proceeds from the exercise of stock options | 279 | 159 |
Payment of deferred financing fees | (622) | |
Net cash provided by financing activities | 279 | 42,760 |
Net (decrease) increase in cash and cash equivalents | (7,295) | 36,310 |
Cash and cash equivalents-beginning of period | 43,930 | 14,994 |
Cash and cash equivalents-end of period | 36,635 | 51,304 |
Supplemental schedule of noncash investing activities: | ||
Unrealized gain on available for sale securities | 31 | |
Supplemental schedule of noncash financing activities: | ||
Accretion of redeemable convertible preferred stock | $ 350 | |
Reclassification of share repurchase obligation | $ 37 |
Organization and Description of
Organization and Description of the Business | 6 Months Ended |
Jun. 30, 2015 | |
Organization and Description of the Business | |
Organization and Description of the Business | 1. Organization and Description of the Business Loxo Oncology, Inc. (the “Company”) was incorporated on May 9, 2013 in the State of Delaware. The Company is committed to the discovery, development, and commercialization of targeted cancer therapies with best-in-class potential. Loxo Oncology, Inc.’s diverse pipeline reflects the convergence of proven therapeutic technologies with emerging insights into the underlying susceptibilities of cancer and drug resistance. The Company operates in one segment and has its principal office in Stamford, Connecticut. Liquidity At June 30, 2015, the Company had working capital of $101.4 million and an accumulated deficit of $45.2 million. The Company had cash, cash equivalents and investments of $101.8 million at June 30, 2015. The Company has not generated any product revenues and has not achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and, if achieved, could be sustained on a continuing basis. In addition, development activities, clinical and pre-clinical testing, and commercialization of the Company’s products will require significant additional capital. The Company believes that its existing cash, cash equivalents, and investments, will be sufficient to enable the Company to continue as a going-concern for a reasonable period of time beyond June 30, 2016. However, the Company will need to secure additional funding in the future, from one or more equity or debt financings, collaborations, or other sources, in order to carry out all of its planned research and development activities. If the Company is unable to obtain additional financing or generate license or product revenue, the lack of liquidity could have a material adverse effect on the Company’s future prospects. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2015 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Unaudited Interim Financial Information The accompanying balance sheet as of December 31, 2014, was derived from the Company’s audited financial statements included in Form 10-K filed on March 27, 2015. It is suggested that the interim unaudited condensed financial statements be read in conjunction with the annual financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K. The accompanying balance sheet as of June 30, 2015, the statements of operations for the three and six months ended June 30, 2015 and 2014, the statements of comprehensive loss for the three and six months ended June 30, 2015 and 2014, the statement of stockholders’ equity for the six months ended June 30, 2015 and the statements of cash flows for the six months ended June 30, 2015 and 2014 are unaudited. The interim unaudited condensed financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2015 and the results of its operations for the three and six months ended June 30, 2015 and 2014 as well as its cash flows for the six months ended June 30, 2015 and 2014. The interim unaudited condensed financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading. Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended December 31, 2014 included in the Company’s Form 10-K filed on March 27, 2015 with the United States Securities and Exchange Commission on the SEC. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. Reclassifications Certain reclassifications were made to prior period amounts to correct the previous presentation. During the three and six months ended June 30, 2014, $165,000 and $223,000, respectively, of certain expenses that had been previously classified as general and administrative were reclassified into research and development. |
Net Loss Per Common Share
Net Loss Per Common Share | 6 Months Ended |
Jun. 30, 2015 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 3. Net Loss Per Common Share The following table sets forth the computation of basic and diluted net loss per common share for the periods indicated (in thousands, except share and per share data): Three Months Three Months Six Months Six Months Ended Ended Ended Ended June 30, 2015 June 30, 2014 June 30, 2015 June 30, 2014 Basic and diluted net loss per common share calculation: Net loss $ ) $ ) $ ) $ ) Accretion of redeemable convertible preferred stock — ) — ) Net loss attributable to common stockholders $ ) $ ) $ ) $ ) Weighted average common shares outstanding — basic and diluted Net loss per share of common stock—basic and diluted $ ) $ ) $ ) $ ) The following outstanding securities at June 30, 2015 and 2014 have been excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive: 2015 2014 Redeemable convertible preferred stock — Unvested restricted stock Stock options |
Fair Value Investments
Fair Value Investments | 6 Months Ended |
Jun. 30, 2015 | |
Fair Value Investments. | |
Fair Value Investments | 4. Fair Value Investments Financial Instruments The financial instruments recorded in the Company’s balance sheets include cash and cash equivalents, investments, and accounts payable. Included in cash and cash equivalents are money market funds representing a type of mutual fund required by law to invest in low-risk securities (for example, U.S. government bonds, U.S. Treasury Bills and commercial paper) and overnight repurchase agreements. Money market funds are structured to maintain the fund’s net asset value at $1.00 per unit, which assists in providing adequate liquidity upon demand by the holder. Money market funds pay dividends that generally reflect short-term interest rates. Thus, only the dividend yield fluctuates. Also included in cash and cash equivalents are U.S. government sponsored enterprise debt securities that have a maturity of 3 months or less from their original acquisition date. Due to their short-term maturity, the carrying amounts of cash and cash equivalents (including money market funds), and accounts payable approximate their fair values. The Company classifies its remaining investments as available-for-sale. Gains or losses on securities sold are based on the specific identification method. For investments classified as available-for-sale, the Company records unrealized gains or losses resulting from changes in fair value between measurement dates as a component of other comprehensive income (loss). (amounts in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized (Losses) Fair Value June 30, 2015 Overnight repurchase agreements $ $ — $ — $ Money market funds — — Total included in cash and cash equivalents — Government enterprise debt securities Short-term available-for-sale securities — Total — US Government debt securities Short-term available-for-sale securities — — Total — — Total fair value financial instruments $ $ $ — $ December 31, 2014 Government enterprise debt securities $ $ — $ — $ Money market funds — — Total included in cash and cash equivalents — — Government enterprise debt securities Short-term available-for-sale securities — ) Long-term available-for-sale securities — ) Total — ) Total fair value financial instruments $ $ — $ ) $ Fair value guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: · Level 1—Quoted prices in active markets for identical assets or liabilities. · Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. · Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s financial assets measured at fair value on a recurring basis at June 30, 2015 were as follows (in thousands): Fair Value Measurements at Measurement Date: Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total As Of June 30, 2015 Assets: Government enterprise debt securities $ — $ $ — $ Overnight repurchase agreements — — Money market funds — — US Government debt securities — — Totals $ $ $ — $ The Company’s financial assets measured at fair value on a recurring basis at December 31, 2014 were as follows (in thousands): Fair Value Measurements at Measurement Date: Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total As Of December 31, 2014 Assets: Government enterprise debt securities $ — $ $ — $ Money market funds — — Totals $ $ $ — $ There were no items that were accounted for at fair value on a non-recurring basis for the six months ended June 30, 2015 and 2014. Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents and investments. At June 30, 2015 and December 31, 2014, the Company’s cash and cash equivalents were held by two financial institutions and the amounts on deposit were in excess of FDIC insurance limits. The Company mitigates this risk by depositing its uninsured cash in major well capitalized financial institutions, and by investing excess operating cash in overnight repurchase agreements which are 100% collateralized by U.S. Government backed securities with the Company’s bank. The Company has not recognized any losses on its cash and cash equivalents. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2015 | |
Accrued Expenses. | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2015 December 31, 2014 Research and development expenses $ $ General and administrative expenses Share repurchase obligation — $ $ |
Stock Based Compensation
Stock Based Compensation | 6 Months Ended |
Jun. 30, 2015 | |
Stock-Based Compensation | |
Stock-Based Compensation | 6. Stock-Based Compensation Effective July 2013, the Company adopted the 2013 Equity Incentive Plan, which was amended in November 2013 (the “2013 Plan”). The 2013 Plan provided for the granting of incentive stock options, non-statutory stock options and the issuance of restricted stock awards. As of June 30, 2015, the Company reserved 1,544,615 shares of common stock authorized for issuance in connection with the 2013 Plan. Certain options are eligible for exercise prior to vesting. Exercised but unvested shares are subject to repurchase by the Company at the initial exercise price. In connection with the Company’s initial public offering, no further grants will be made under this plan and all remaining shares available for grant were transferred to the 2014 Equity Incentive Plan. The Company adopted the 2014 Equity Incentive Plan (the “2014 Plan”) that became effective on July 30, 2014 and serves as the successor to the 2013 Plan. The 2014 Plan provides for the grant of awards to employees, directors, consultants, independent contractors and advisors, provided the consultants, independent contractors, directors and advisors are natural persons that render services other than in connection with the offer and sale of securities in a capital-raising transaction. The exercise price of stock options must be at least equal to the fair market value of the Company’s common stock on the date of grant. The Company has reserved 1,591,106 shares of its common stock to be issued under the 2014 Plan of which 989,743 shares were available for future issuance as of June 30, 2015. Shares authorized will increase automatically on January 1 of each of 2015 through 2024 by the number of shares equal to 3.0% of the aggregate number of outstanding shares of our common stock as of the immediately preceding December 31. The Company’s Board may reduce the amount of the increase in any particular year. The 2014 Plan authorizes the award of stock options, restricted stock awards, or RSAs, stock appreciation rights, or SARs, restricted stock units, or RSUs, performance awards and stock bonuses. Certain options are eligible for exercise prior to vesting. Exercised but unvested shares are subject to repurchase by the Company at the initial exercise price. The proceeds from the shares subject to repurchase are classified as a liability and reclassified to equity as the shares vest. The following table summarizes stock option activity under the 2014 Plan for the period from January 1, 2015 through June 30, 2015: Average Weighted- Remaining Aggregate Number Average Contractual Intrinsic Value of Shares Exercise Price Term (in years) (in thousands) Outstanding at January 1, 2015 $ $ Granted Exercised ) Cancelled — — Forfeited ) Outstanding at June 30, 2015 $ $ Vested and expected to vest at June 30, 2015 $ $ Exercisable at June 30, 2015 $ $ Weighted-average grant date fair value of options granted during the six months ended June 30, 2015 $ As of June 30, 2015, there was $12.4 million of total unrecognized compensation expense related to options granted but not yet vested of which $3.4 million is attributable to non-employee awards and subject to re-measurement until vested. The total unrecognized compensation expense of $12.4 million will be recognized as expense over a weighted-average period of 3.0 years. The Company uses the Black-Scholes option pricing model to estimate the fair value of option awards with the following weighted-average assumptions, certain of which are based on industry comparative information, for the period indicated: Six Months Ended June 30, 2015 Risk-free interest rate % Expected dividend yield % Expected stock price volatility % Expected term of options (in years) Expected forfeiture rate % The weighted-average valuation assumptions were determined as follows: · Risk-free interest rate: The Company bases the risk-free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term. · Expected annual dividends: The estimate for annual dividends is 0%, because the Company has not historically paid, and does not expect for the foreseeable future to pay, a dividend. · Expected stock price volatility: The expected volatility used is based on historical volatilities of similar entities within the Company’s industry which were commensurate with the Company’s expected term assumption. · Expected term of options: The expected term of options represents the period of time options are expected to be outstanding. The expected term of the options granted to employees is derived from the “simplified” method as described in Staff Accounting Bulletin 107 relating to stock-based compensation. The expected term for options granted to non-employees is equal to the contractual term of the awards. · Expected forfeiture rate: The Company’s estimated annual forfeiture rate was 6.59%, based on historical forfeiture experience of its various employee groups. · Estimated fair value of the Company’s stock-based awards: The estimated fair value of the Company’s stock-based awards is amortized on a straight-line basis over the awards’ service period for those awards with graded vesting and which contain only a service condition. For awards with graded vesting and a performance and service condition, when achievement of the performance condition is deemed probable, the Company recognizes compensation cost using the accelerated recognition method over the awards’ service period. Share-based compensation expense recognized was as follows (in thousands): Three Months Ended June 30, 2015 Three Months Ended June 30, 2014 Six Months Ended June 30, 2015 Six Months Ended June 30, 2014 Research and development $ $ $ $ General and administrative $ $ $ $ The stock-based compensation expense for restricted stock is determined based on the estimated fair value of the Company’s common stock on the grant date of the awards applied to the total number of awards that are anticipated to vest. During 2013, the Company granted 264,189 restricted stock awards and as of December 31, 2014 there were 170,622 shares expected to vest over the next 3 years. During the six months ended June 30, 2015, 33,024 restricted shares vested and the remaining 137,598 shares are expected to vest over the next 2.5 years. Stock-based compensation for restricted stock was de minimis at their original grant date. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2015 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 7. Commitments and Contingencies Array Collaboration Agreement On July 3, 2013, the Company signed a multi-year strategic collaboration agreement with Array BioPharma, Inc. (“Array”), and this agreement was subsequently amended on November 26, 2013, April 10, 2014, October 13, 2014 and March 31, 2015. The March 31, 2015 amendment was to provide additional full-time equivalents and other support dedicated to the conduct of the discovery, preclinical and clinical development programs for the remainder of 2015. Under the terms of the collaboration agreement, the Company obtained certain rights to Array’s tropomyosin receptor kinase (TRK) inhibitor program, as well as additional novel oncology targets, including rearranged during transfection (RET), fibroblast growth factor receptor (FGFR) and FMS-like tyrosine kinase 3 (FLT3). The Company has worldwide commercial rights to each product candidate from the collaboration and Array participates in any potential successes through milestones, royalties, and an equity ownership in the Company. With respect to the discovery and preclinical program, the collaboration agreement runs through July 3, 2016, and the Company has the option to extend the term for up to two additional one-year renewal periods by providing written notice to Array at least three months before the end of the initial discovery and preclinical development programs or the renewal period, if applicable. In addition to LOXO-101, the parties designated 12 discovery targets, of which seven were selected for additional study in January 2015, which will be reduced to four on or before January 2016. The Company has the option to increase the total candidate selection number to five for a modest additional payment. As part of the agreement the, Company agreed to pay Array a fixed amount per month, based on Array’s commitment to provide full-time equivalents and other support relating to the conduct of the discovery and preclinical development programs. See Note 8 for amounts the Company recorded in related-party research and development expenses. Milestones With respect to product candidates directed to TRK, including LOXO-101 and its back-up compounds, the Company could be required to pay Array up to $222 million in milestone payments, the substantial majority of which are due upon the achievement of commercial milestones. With respect to product candidates directed to targets other than TRK, the Company could be required to pay Array up to $213 million in milestone payments, the substantial majority of which are due upon the achievement of commercial milestones. Royalties The Company is required to pay Array mid-single digit royalties on worldwide net sales of products. With respect to the royalty on products directed to targets other than TRK, the Company has the right to credit certain milestone payments against royalties on sales of products directed to such target. Research and Development Arrangements In the course of normal business operations, the Company enters into agreements with clinical research organizations, or CROs, to assist in the performance of research and development and preclinical activities. Expenditures to CROs may represent a significant portion of development costs for the Company in future periods. The Company can elect to discontinue the work under these agreements at any time. The Company could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and even long-term commitments of cash. Legal Proceedings The Company is not involved in any legal proceeding that it expects to have a material effect on its business, financial condition, results of operations or cash flows. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2015 | |
Related Party Transactions | |
Related Party Transactions | 8. Related Party Transactions The Company recorded related-party research and development expenses of $4.8 million and $3.0 million for the six months ended June 30, 2015 and 2014, respectively, for services provided by Array under a collaboration agreement. The Company recorded related-party research and development expenses of $2.9 million and $1.7 million for the three months ended June 30, 2015 and 2014, respectively, for services provided by Array under a collaboration agreement. As of June 30, 2015, the Company had $1.0 million in prepaid expenses to Array under the collaboration agreement for services that will be provided in subsequent periods and $48,000 in accrued expenses already incurred. Dr. Lori Kunkel, a board member, has a consulting agreement with the Company to assist in the Company’s drug development process. Dr. Kunkel is eligible to receive a maximum of $15,000 monthly for her consulting work. Payments are expensed as incurred and recorded as a component of research and development expenses. During the three and six months ended June 30, 2015, the Company recognized expenses of $ 45,000 and $90,000, respectively, in accordance with the terms of the consulting agreement. As of June 30, 2015, there was $15,000 included in accrued expenses to Dr. Kunkel. |
Summary of Significant Accoun17
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2015 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying balance sheet as of December 31, 2014, was derived from the Company’s audited financial statements included in Form 10-K filed on March 27, 2015. It is suggested that the interim unaudited condensed financial statements be read in conjunction with the annual financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K. The accompanying balance sheet as of June 30, 2015, the statements of operations for the three and six months ended June 30, 2015 and 2014, the statements of comprehensive loss for the three and six months ended June 30, 2015 and 2014, the statement of stockholders’ equity for the six months ended June 30, 2015 and the statements of cash flows for the six months ended June 30, 2015 and 2014 are unaudited. The interim unaudited condensed financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2015 and the results of its operations for the three and six months ended June 30, 2015 and 2014 as well as its cash flows for the six months ended June 30, 2015 and 2014. The interim unaudited condensed financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended December 31, 2014 included in the Company’s Form 10-K filed on March 27, 2015 with the United States Securities and Exchange Commission on the SEC. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. |
Reclassifications | Reclassifications Certain reclassifications were made to prior period amounts to correct the previous presentation. During the three and six months ended June 30, 2014, $165,000 and $223,000, respectively, of certain expenses that had been previously classified as general and administrative were reclassified into research and development. |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Net Loss Per Common Share | |
Schedule of computation of basic and diluted net loss per common share | The following table sets forth the computation of basic and diluted net loss per common share for the periods indicated (in thousands, except share and per share data): Three Months Three Months Six Months Six Months Ended Ended Ended Ended June 30, 2015 June 30, 2014 June 30, 2015 June 30, 2014 Basic and diluted net loss per common share calculation: Net loss $ ) $ ) $ ) $ ) Accretion of redeemable convertible preferred stock — ) — ) Net loss attributable to common stockholders $ ) $ ) $ ) $ ) Weighted average common shares outstanding — basic and diluted Net loss per share of common stock—basic and diluted $ ) $ ) $ ) $ ) |
Schedule of outstanding securities excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive | 2015 2014 Redeemable convertible preferred stock — Unvested restricted stock Stock options |
Fair Value Investments (Table)
Fair Value Investments (Table) | 6 Months Ended |
Jun. 30, 2015 | |
Fair Value Investments. | |
Schedule of available-for-sale securities unrealized gains and losses from changes in fair value | (amounts in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized (Losses) Fair Value June 30, 2015 Overnight repurchase agreements $ $ — $ — $ Money market funds — — Total included in cash and cash equivalents — Government enterprise debt securities Short-term available-for-sale securities — Total — US Government debt securities Short-term available-for-sale securities — — Total — — Total fair value financial instruments $ $ $ — $ December 31, 2014 Government enterprise debt securities $ $ — $ — $ Money market funds — — Total included in cash and cash equivalents — — Government enterprise debt securities Short-term available-for-sale securities — ) Long-term available-for-sale securities — ) Total — ) Total fair value financial instruments $ $ — $ ) $ |
Schedule of financial assets measured at fair value on a recurring basis | The Company’s financial assets measured at fair value on a recurring basis at June 30, 2015 were as follows (in thousands): Fair Value Measurements at Measurement Date: Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total As Of June 30, 2015 Assets: Government enterprise debt securities $ — $ $ — $ Overnight repurchase agreements — — Money market funds — — US Government debt securities — — Totals $ $ $ — $ The Company’s financial assets measured at fair value on a recurring basis at December 31, 2014 were as follows (in thousands): Fair Value Measurements at Measurement Date: Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total As Of December 31, 2014 Assets: Government enterprise debt securities $ — $ $ — $ Money market funds — — Totals $ $ $ — $ |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Accrued Expenses. | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2015 December 31, 2014 Research and development expenses $ $ General and administrative expenses Share repurchase obligation — $ $ |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Stock-Based Compensation | |
Summary of stock option activity under the 2014 Plan | Average Weighted- Remaining Aggregate Number Average Contractual Intrinsic Value of Shares Exercise Price Term (in years) (in thousands) Outstanding at January 1, 2015 $ $ Granted Exercised ) Cancelled — — Forfeited ) Outstanding at June 30, 2015 $ $ Vested and expected to vest at June 30, 2015 $ $ Exercisable at June 30, 2015 $ $ Weighted-average grant date fair value of options granted during the six months ended June 30, 2015 $ |
Schedule of weighted-average assumptions under the Black-Scholes option pricing model estimate the fair value of option awards | Six Months Ended June 30, 2015 Risk-free interest rate % Expected dividend yield % Expected stock price volatility % Expected term of options (in years) Expected forfeiture rate % |
Schedule of Share-based compensation expense recognized | Share-based compensation expense recognized was as follows (in thousands): Three Months Ended June 30, 2015 Three Months Ended June 30, 2014 Six Months Ended June 30, 2015 Six Months Ended June 30, 2014 Research and development $ $ $ $ General and administrative $ $ $ $ |
Organization and Description 22
Organization and Description of the Business (Details) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2015USD ($)item | Dec. 31, 2014USD ($)item | |
Organization and Description of the Business | ||
Number of operating segments | item | 1 | 1 |
Working capital | $ 101,400 | |
Accumulated deficit | 45,200 | $ 30,962 |
Cash, cash equivalents and investments | $ 101,800 |
Summary of Significant Accoun23
Summary of Significant Accounting Policies (Details) - Jun. 30, 2015 - USD ($) | Total | Total |
Summary of Significant Accounting Policies | ||
General and administrative expenses reclassified into research and development | $ 165,000 | $ 223,000 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Basic and diluted net loss per common share calculation: | ||||
Net loss | $ (8,056) | $ (3,905) | $ (14,238) | $ (6,807) |
Accretion of redeemable convertible preferred stock | (17) | (28) | ||
Net loss attributable to common stockholders | $ (8,056) | $ (3,922) | $ (14,238) | $ (6,835) |
Weighted average common shares outstanding-basic and diluted (in shares) | 16,540,764 | 271,317 | 16,507,700 | 238,246 |
Net loss per share of common stock-basic and diluted (in dollars per share) | $ (0.49) | $ (14.46) | $ (0.86) | $ (28.69) |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 2,115,371 | 10,319,083 | ||
Redeemable convertible preferred stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 8,823,187 | |||
Unvested restricted stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 137,598 | 264,190 | ||
Stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 1,977,773 | 1,231,706 |
Fair Value Investments (Detail)
Fair Value Investments (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Net asset value for money market funds (in dollars per unit) | $ 1 | $ 1 |
Overnight repurchase agreements | ||
Amortized Cost | $ 18,500 | |
Fair Value | 18,500 | |
US Government-sponsored Enterprises Debt Securities | ||
Amortized Cost | $ 17,009 | |
Fair Value | 17,009 | |
Money Market Funds | ||
Amortized Cost | 11,268 | 8,846 |
Fair Value | 11,268 | 8,846 |
Cash and cash equivalents | ||
Amortized Cost | 29,768 | 25,855 |
Fair Value | 29,768 | 25,855 |
Government enterprise Short-term available-for-sale securities | ||
Amortized Cost | 64,162 | 62,387 |
Gross Unrealized Gains | 3 | |
Gross Unrealized (Losses) | (25) | |
Fair Value | 64,165 | 62,362 |
Government enterprise Long-term available-for-sale securities | ||
Amortized Cost | 6,651 | |
Gross Unrealized (Losses) | (3) | |
Fair Value | 6,648 | |
Government enterprise AFS securities | ||
Amortized Cost | 64,162 | 69,038 |
Gross Unrealized Gains | 3 | |
Gross Unrealized (Losses) | (28) | |
Fair Value | 64,165 | 69,010 |
US Government Short Term Available for Sale | ||
Amortized Cost | 1,000 | |
Fair Value | 1,000 | |
US Government Debt Securities | ||
Amortized Cost | 1,000 | |
Fair Value | 1,000 | |
Available-for-sale securities. | ||
Amortized Cost | 94,930 | 94,893 |
Gross Unrealized Gains | 3 | |
Gross Unrealized (Losses) | (28) | |
Fair Value | $ 94,933 | $ 94,865 |
Fair Value Investments (Detail
Fair Value Investments (Detail 2) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2015USD ($)Institution | Dec. 31, 2014USD ($)Institution | Jun. 30, 2014USD ($) | |
Number of financial institutions that hold cash and cash equivalents for the Company | Institution | 2 | 2 | |
Percentage of repurchase agreements collateralized by US Government backed securities (as a percent) | 100.00% | 100.00% | |
Recurring | |||
Available-for-sale | $ 94,933 | $ 94,865 | |
Non-recurring | |||
Investments | 0 | $ 0 | |
Fair Value, Inputs, Level 1 | Recurring | |||
Available-for-sale | 30,768 | 8,846 | |
Fair Value, Inputs, Level 2 | Recurring | |||
Available-for-sale | 64,165 | 86,019 | |
US Government-sponsored Enterprises Debt Securities | Recurring | |||
Available-for-sale | 64,165 | 86,019 | |
US Government-sponsored Enterprises Debt Securities | Fair Value, Inputs, Level 2 | Recurring | |||
Available-for-sale | 64,165 | 86,019 | |
Overnight repurchase agreements | Recurring | |||
Available-for-sale | 18,500 | ||
Overnight repurchase agreements | Fair Value, Inputs, Level 1 | Recurring | |||
Available-for-sale | 18,500 | ||
Money Market Funds | Recurring | |||
Available-for-sale | 11,268 | 8,846 | |
Money Market Funds | Fair Value, Inputs, Level 1 | Recurring | |||
Available-for-sale | 11,268 | $ 8,846 | |
US Government Debt Securities | Recurring | |||
Available-for-sale | 1,000 | ||
US Government Debt Securities | Fair Value, Inputs, Level 1 | Recurring | |||
Available-for-sale | $ 1,000 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Accrued Expenses and Other Current Liabilities | ||
Accrued Expenses | $ 1,403 | $ 1,548 |
Research and development | ||
Accrued Expenses and Other Current Liabilities | ||
Accrued Expenses | 912 | 742 |
General and administrative | ||
Accrued Expenses and Other Current Liabilities | ||
Accrued Expenses | $ 491 | 769 |
Shares repurchase obligation | ||
Accrued Expenses and Other Current Liabilities | ||
Accrued Expenses | $ 37 |
Stock Based Compensation (Detai
Stock Based Compensation (Details) - Jun. 30, 2015 - shares | Total |
2013 Plan | |
2013 and 2014 Equity Incentive Plan | |
Shares authorized for issuance | 1,544,615 |
Shares available for future issuance (in shares) | 0 |
2014 Plan | |
2013 and 2014 Equity Incentive Plan | |
Shares authorized for issuance | 1,591,106 |
Shares available for future issuance (in shares) | 989,743 |
Increase in common stock reserved for issuance as percentage of the aggregate number of outstanding shares of common stock (as a percent) | 3.00% |
Stock Based Compensation (Det29
Stock Based Compensation (Details 2) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2015 | Dec. 31, 2014 | |
Weighted average assumptions used to estimate fair value of option awards using Black Scholes option pricing model | ||
Unrecognized compensation expense | $ 12,400 | |
2013 and 2014 Equity Incentive Plans | Stock option | ||
Weighted average assumptions used to estimate fair value of option awards using Black Scholes option pricing model | ||
Unrecognized compensation expense | $ 12,400 | |
2014 Plan | Stock option | ||
Number of Shares | ||
Outstanding at the beginning of the period (in shares) | 2,011,005 | |
Granted (in shares) | 99,725 | |
Exercised (in shares) | (53,373) | |
Forfeited (in shares) | (79,584) | |
Outstanding at the end of the period (in shares) | 1,977,773 | 2,011,005 |
Vested and expected to vest at the end of the period (in shares) | 1,906,654 | |
Exercisable at the end of the period (in shares) | 689,660 | |
Weighted average grant date fair value of options granted (in dollars per share) | $ 8 | |
Weighted Average Exercise Price | ||
Outstanding at the beginning of the period (in dollars per share) | 6.75 | |
Granted (in dollars per share) | 11.87 | |
Exercised (in dollars per share) | 5.92 | |
Forfeited (in dollars per share) | 7.50 | |
Outstanding at the end of the period (in dollars per share) | 7 | $ 6.75 |
Vested and expected to vest at the end of the period (in dollars per share) | 6.94 | |
Exercisable at the end of the period (in dollars per share) | $ 3.66 | |
Average Remaining Contractual Term | ||
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2 | 9 years | 9 years 6 months |
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2 | 9 years | 9 years 6 months |
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1 | 9 years | |
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableWeightedAverageRemainingContractualTerm1 | 8 years 8 months 12 days | |
Aggregate Intrinsic Value | ||
Outstanding at the end of the period | $ 21,813 | $ 11,375 |
Vested and expected to vest at the end of the period | 21,137 | |
Exercisable at the end of the period | $ 9,910 | |
Weighted average assumptions used to estimate fair value of option awards using Black Scholes option pricing model | ||
Risk-free interest rate | 1.62% | |
Expected dividend yield | 0.00% | |
Expected stock price volatility | 76.80% | |
Expected term of options (in years) | 6 years 15 days | |
Expected forfeiture rate | 6.59% | |
Weighted-average period for recognition | 3 years | |
Non-employees | ||
Weighted average assumptions used to estimate fair value of option awards using Black Scholes option pricing model | ||
Unrecognized compensation expense | $ 3,400 |
Stock Based Compensation (Det30
Stock Based Compensation (Details 3) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | |
2013 and 2014 Equity Incentive Plans | ||||||
Stock based compensation expense | ||||||
Share-based compensation expense | $ 1,635 | $ 473 | $ 2,684 | $ 537 | ||
2013 and 2014 Equity Incentive Plans | Research and development | ||||||
Stock based compensation expense | ||||||
Share-based compensation expense | 882 | 281 | 1,344 | 325 | ||
2013 and 2014 Equity Incentive Plans | General and administrative | ||||||
Stock based compensation expense | ||||||
Share-based compensation expense | $ 753 | $ 192 | $ 1,340 | $ 212 | ||
Restricted Stock Awards | ||||||
Restricted Stock | ||||||
Granted (in shares) | 264,189 | |||||
Vested (in shares) | 33,024 | |||||
Expected to vest (in shares) | 137,598 | 137,598 | 170,622 | |||
Vesting period | 2 years 6 months | 3 years |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Thousands | Oct. 13, 2014item | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($)item |
Commitments and contingencies | |||||
Related party research and development expenses | $ | $ 2,919 | $ 1,717 | $ 4,837 | $ 2,992 | |
Collaboration agreement | Array | |||||
Commitments and contingencies | |||||
Term of additional renewal periods options available to the entity to extend agreement term (in options) | 1 year | ||||
Number of discovery targets designated by the parties (in targets) | 12 | ||||
Number of discovery targets which are to be selected for additional study on or before January 2015 (in targets) | 7 | ||||
Number of discovery targets which are to be selected for additional study after reduction on or before January 2016 (in targets) | 4 | ||||
Maximum number of candidates which can be selected by the entity for modest additional payment (in candidates) | 5 | ||||
Related party research and development expenses | $ | 2,900 | $ 1,700 | 4,800 | $ 3,000 | |
Collaboration agreement | Maximum | Array | |||||
Commitments and contingencies | |||||
Number of additional renewal periods options available to the entity to extend agreement term (in periods) | 2 | ||||
Collaboration agreement | Product candidates directed to TRK | Array | |||||
Commitments and contingencies | |||||
Maximum milestone payments which the entity could be required to pay | $ | 222,000 | 222,000 | |||
Collaboration agreement | Product candidates directed to targets other than TRK | Array | |||||
Commitments and contingencies | |||||
Maximum milestone payments which the entity could be required to pay | $ | $ 213,000 | $ 213,000 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | Oct. 23, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 |
Related party transactions | ||||||
Related party research and development expenses | $ 2,919,000 | $ 1,717,000 | $ 4,837,000 | $ 2,992,000 | ||
Accrued Expenses | 1,403,000 | 1,403,000 | $ 1,548,000 | |||
Dr. Lori Kunkel | ||||||
Related party transactions | ||||||
Maximum monthly fees for consulting work | $ 15,000 | |||||
Dr. Lori Kunkel | Accounts payable | ||||||
Related party transactions | ||||||
Accrued expenses to related parties | 15,000 | 15,000 | ||||
Dr. Lori Kunkel | Research and development | ||||||
Related party transactions | ||||||
Expenses recognized for consulting work | 45,000 | 90,000 | ||||
Collaboration agreement | Array | ||||||
Related party transactions | ||||||
Related party research and development expenses | 2,900,000 | $ 1,700,000 | 4,800,000 | $ 3,000,000 | ||
Accrued Expenses | 48,000 | 48,000 | ||||
Prepaid expenses | $ 1,000,000 | $ 1,000,000 |