QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
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☒ |
Accelerated filer |
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Non-accelerated filer |
☐ |
Smaller reporting company |
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Emerging growth company |
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Item |
Description |
Page |
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3 |
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Item 1. |
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6 |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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23 |
Item 1. |
Financial Statements. |
June 30, 2019 |
December 31, 2018 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | |
$ | |
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Marketable securities |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Right-of-use asset |
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— |
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Total assets |
$ | |
$ | |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
$ | |
$ | |
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Accrued expenses |
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Lease liability |
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— |
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Total current liabilities |
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Long term liabilities: |
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Lease liability |
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— |
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Total long term liabilities |
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— |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock, par value $ |
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Common stock, par value $ |
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Additional paid-in-capital |
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Accumulated other comprehensive gain (loss) |
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Accumulated deficit |
( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ | |
$ | |
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Three Months Ended June 30, |
Six Months Ended June 30, |
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2019 |
2018 |
2019 |
2018 |
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Revenues: |
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Total revenues |
$ | — |
$ | — |
$ | — |
$ | — |
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
( |
) | ( |
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) | ( |
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Interest income |
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Other income |
— |
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— |
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
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Net loss per common share: |
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Basic and diluted net loss per common share |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
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Basic and diluted weighted average number of common shares outstanding |
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Three Months Ended June 30, |
Six Months Ended June 30, |
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2019 |
2018 |
2019 |
2018 |
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Net Loss |
$ | ( |
) | $ | ( |
) | $ | (34,779 |
) | $ | ( |
) | ||||
Other comprehensive income (loss): |
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Unrealized gain (loss) on available-for-sale securities |
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( |
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Comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Additional paid-in Capital |
Accumulated other comprehensive income (loss) |
Accumulated deficit |
Total stockholders’ equity |
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Preferred stock |
Common stock |
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Shares |
Amount |
Shares |
Amount |
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Balance at December 31, 2018 |
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$ | — |
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$ | |
$ | |
$ | ( |
) | $ | ( |
) | $ | |
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Exercise of common stock options |
— |
— |
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— |
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— |
— |
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Compensation expense related to stock options for services |
— |
— |
— |
— |
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— |
— |
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Unrealized gain on marketable securities |
— |
— |
— |
— |
— |
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— |
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Net loss |
— |
— |
— |
— |
— |
— |
( |
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Balance at March 31, 2019 |
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$ | — |
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$ | |
$ | |
$ | |
$ | ( |
) | $ | |
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Exercise of common stock options |
— |
— |
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— |
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— |
— |
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Compensation expense related to stock options for services |
— |
— |
— |
— |
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— |
— |
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Unrealized gain on marketable securities |
— |
— |
— |
— |
— |
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— |
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Net loss |
— |
— |
— |
— |
— |
— |
( |
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Balance at June 30, 2019 |
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$ | — |
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$ | |
$ | |
$ | |
$ | ( |
) | $ | |
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Balance at December 31, 2017 |
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$ | — |
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$ | |
$ | |
$ | ( |
) | $ | ( |
) | $ | |
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Exercise of common stock options |
— |
— |
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— |
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— |
— |
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Compensation expense related to stock options for services |
— |
— |
— |
— |
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— |
— |
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Unrealized loss on marketable securities |
— |
— |
— |
— |
— |
( |
) | — |
( |
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Net loss |
— |
— |
— |
— |
— |
— |
( |
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Balance at March 31, 2018 |
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$ | — |
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$ | |
$ | |
$ | ( |
) | $ | ( |
) | $ | |
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Exercise of common stock options |
— |
— |
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— |
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— |
— |
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Issuance of common shares in equity offering, excluding related parties, net of transaction costs |
— |
— |
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— |
— |
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Compensation expense related to stock options for services |
— |
— |
— |
— |
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— |
— |
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Unrealized gain on marketable securities |
— |
— |
— |
— |
— |
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— |
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Net loss |
— |
— |
— |
— |
— |
— |
( |
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Balance at June 30, 2018 |
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$ | — |
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$ | |
$ | |
$ | ( |
) | $ | ( |
) | $ | |
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Six Months Ended June 30, |
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2019 |
2018 |
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Cash flows from operating activities: |
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Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation expense |
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Depreciation and amortization expense |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
( |
) | ( |
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Accounts payable |
( |
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Accrued expense |
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( |
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Accrued interest, net of interest received on maturity of investments |
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— |
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Net cash used in operating activities |
( |
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Cash flows from investing activities: |
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Purchases of marketable securities |
( |
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Sales and maturities of marketable securities |
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Purchases of property and equipment, net of disposals |
( |
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Net cash used in investing activities |
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( |
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Cash flows from financing activities: |
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Proceeds from issuances of stock, excluding related parties, net of transaction costs |
— |
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Proceeds from the exercise of common stock options |
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Net cash provided by financing activities |
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Net increase in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
$ | |
$ | |
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Supplemental disclosure of cash flow information: |
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Obtaining a right-of-use asset in exchange for a lease liability |
$ | |
$ | — |
Three and Six Months Ended June 30, |
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2019 |
2018 |
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Common Stock Options |
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Unvested Restricted Common Stock |
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Preferred Stock |
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June 30, 2019 |
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Cost |
Unrealized |
Unrealized |
Fair |
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gains |
losses |
value |
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Cash and cash equivalents: |
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Cash (Level 1) |
$ | |
$ | — |
$ | — |
$ | |
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Money market funds (Level 1) |
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— |
— |
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Corporate debt securities due within |
— |
— |
— |
— |
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Total cash and cash equivalents |
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— |
— |
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Marketable securities: |
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Corporate debt securities due within |
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— |
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Corporate debt securities due within |
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( |
) | |
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Total cash, cash equivalents and marketable securities |
$ | |
$ | |
$ | ( |
) | $ | |
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December 31, 2018 |
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Cost |
Unrealized gains |
Unrealized losses |
Fair value |
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Cash and cash equivalents: |
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Cash (Level 1) |
$ | $ | — |
$ | — |
$ | ||||||||||
Money market funds (Level 1) |
— |
— |
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Corporate debt securities due within |
— |
— |
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Total cash and cash equivalents |
— |
— |
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Marketable securities: |
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Corporate debt securities due within |
( |
) | ||||||||||||||
Total cash, cash equivalents and marketable securities |
$ | $ | $ | ( |
) | $ | ||||||||||
Shares |
Weighted average exercise price |
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Outstanding at January 1, 2019 |
$ | |||||||
Options granted |
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Options exercised |
( |
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Options cancelled |
— |
— |
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Outstanding at June 30, 2019 |
$ | |||||||
Exercisable at June 30, 2019 |
$ |
Three Months Ended June 30, |
Six Months Ended June 30, |
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2019 |
2018 |
2019 |
2018 |
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Stock-based compensation expense by type of award: |
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Stock options |
$ | $ | $ | $ | ||||||||||||
Restricted stock |
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Total stock-based compensation expense |
$ | $ | $ | $ | ||||||||||||
Effect of stock-based compensation expense by line item: |
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Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
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Total stock-based compensation expense included in net loss |
$ | 7,755 |
$ | 2,227 |
$ | 13,777 |
$ | 3,394 |
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Weighted |
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Unrecognized |
average |
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stock |
remaining |
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compensation |
period |
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expense |
(in years) |
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Stock options |
$ | |||||||
Restricted stock |
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Total |
$ | |||||||
Operating Leases |
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2019 |
$ | |||
2020 |
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2021 |
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2022 |
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Thereafter |
— |
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Total minimum payments |
$ | |||
Less: imputed interest |
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Present value of lease liabilities |
$ |
I
tem 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
• | salaries and related expense, including stock-based compensation; |
• | external expenses paid to clinical trial sites, contract research organizations, laboratories, database software providers and consultants that conduct clinical trials; |
• | expenses related to development and the production of nonclinical and clinical trial supplies, including fees paid to contract manufacturers; |
• | expenses related to preclinical studies; |
• | expenses related to compliance with drug development regulatory requirements; and |
• | other allocated expenses, which include direct and allocated expenses for depreciation of equipment and other supplies. |
Three Months Ended June 30, |
Increase / (Decrease) |
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2019 |
2018 |
$ |
% |
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Research and Development Expenses |
$ | 15,594 |
$ | 5,109 |