September 30, 2020 |
December 31, 2019 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | $ | ||||||
Marketable securities |
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Prepaid expenses and other current assets |
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|
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|
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Total current assets |
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Property and equipment, net |
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Right-of-use |
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|
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Total assets |
$ | $ | ||||||
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|
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
$ | $ | ||||||
Accrued expenses |
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Lease liability |
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Total current liabilities |
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Long term liabilities: |
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Lease liability |
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Total long term liabilities |
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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 |
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Accumulated deficit |
( |
) | ( |
) | ||||
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|
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Total stockholders’ equity |
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|
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Total liabilities and stockholders’ equity |
$ | $ | ||||||
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|
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
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2020 |
2019 |
2020 |
2019 |
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Revenues: |
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Total revenues |
$ | $ | $ | $ | ||||||||||||
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 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Interest income |
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Other income |
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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|
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|
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Net loss per common share: |
||||||||||||||||
Basic and diluted net loss per common share |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Basic and diluted weighted average number of common shares outstanding |
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||||||||
Net Loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Other comprehensive income (loss): |
||||||||||||||||
Unrealized gain (loss) on available-for-sale |
( |
) | ( |
) | ||||||||||||
|
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|
|
|
|
|
|
|||||||||
Comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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|
|
|
|
|
|
|
Preferred stock |
Common stock |
Additional paid-in Capital |
Accumulated other comprehensive income (loss) |
Accumulated deficit |
Total stockholders’ equity |
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Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||||||
Balance at December 31, 2019 |
$ | — | $ | $ | |
$ | $ | ( |
) | $ | |
|||||||||||||||||||||
Compensation expense related to stock options for services |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Unrealized gain on marketable securities |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at March 31, 2020 |
$ | — | $ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||||
Exercise of common stock options |
— | — | — | — | — | |||||||||||||||||||||||||||
Compensation expense related to stock options for services |
— |
— | — |
— | — | — | ||||||||||||||||||||||||||
Unrealized gain on marketable securities |
— |
— | — |
— | — | — | ||||||||||||||||||||||||||
Net loss |
— |
— | — |
— | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at June 30, 2020 |
$ | — | $ | $ | $ | |
$ | ( |
) | $ | ||||||||||||||||||||||
Exercise of common stock options |
— | — | — | — | — | |||||||||||||||||||||||||||
Compensation expense related to stock options for services |
— |
— | — |
— | — | — | ||||||||||||||||||||||||||
Unrealized loss on marketable securities |
— |
— | — |
— | — | ( |
) | — | ( |
) | ||||||||||||||||||||||
Net loss |
— |
— | — |
— | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at September 30, 2020 |
$ | — | $ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at December 31, 2018 |
$ | — | $ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||||||||
Exercise of common stock options |
— | — | — | — | — | |||||||||||||||||||||||||||
Compensation expense related to stock options for services |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Unrealized gain on marketable securities |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at March 31, 2019 |
$ | — | $ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||||
Exercise of common stock options |
— | — | — | — | — | |||||||||||||||||||||||||||
Compensation expense related to stock options for services |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Unrealized gain on marketable securities |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at June 30, 2019 |
$ | — | $ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||||
Exercise of common stock options |
— | — | — | — | — | |||||||||||||||||||||||||||
Compensation expense related to stock options for services |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Unrealized loss on marketable securities |
— | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at September 30, 2019 |
$ | — | $ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
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|
|
Nine Months Ended September 30, |
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2020 |
2019 |
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Cash flows from operating activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Stock-based compensation expense |
||||||||
Depreciation and amortization expense |
||||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
( |
) | ( |
) | ||||
Accounts payable |
( |
) | ||||||
Accrued expenses |
||||||||
Accrued interest, net of interest received on maturity of investments |
||||||||
|
|
|
|
|||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Cash flows from investing activities: |
||||||||
Purchases of marketable securities |
( |
) | ( |
) | ||||
Sales and maturities of marketable securities |
||||||||
Purchases of property and equipment, net of disposals |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net cash provided by investing activities |
||||||||
|
|
|
|
|||||
Cash flows from financing activities: |
||||||||
Proceeds from the exercise of common stock options |
||||||||
|
|
|
|
|||||
Net cash provided by financing activities |
||||||||
|
|
|
|
|||||
Net increase in cash and cash equivalents |
||||||||
Cash and cash equivalents at beginning of period |
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|
|
|
|
|||||
Cash and cash equivalents at end of period |
$ | $ | ||||||
|
|
|
|
|||||
Supplemental disclosure of cash flow information: |
||||||||
Obtaining a right-of-use |
$ | $ |
Nine Months Ended September 30, |
||||||||
2020 |
2019 |
|||||||
Common stock options |
||||||||
Preferred stock |
September 30, 2020 |
||||||||||||||||
Cost |
Unrealized gains |
Unrealized losses |
Fair value |
|||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Cash (Level 1) |
$ | $ | — | $ | — | $ | ||||||||||
Money market funds (Level 1) |
— | — | ||||||||||||||
Corporate debt securities due within |
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total cash and cash equivalents |
— | — | ||||||||||||||
Marketable securities: |
||||||||||||||||
Corporate debt securities due within |
( |
) | ||||||||||||||
U.S. government and government sponsored entities due within |
— | |||||||||||||||
Corporate debt securities due within |
( |
) | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total cash, cash equivalents and marketable securities |
$ | |
$ | |
$ | ( |
) | $ | |
|||||||
|
|
|
|
|
|
|
|
December 31, 2019 |
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Cost |
Unrealized gains |
Unrealized losses |
Fair value |
|||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Cash (Level 1) |
$ | $ | — | $ | — | $ | ||||||||||
Money market funds (Level 1) |
— | — | ||||||||||||||
Corporate debt securities due within |
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total cash and cash equivalents |
— | — | ||||||||||||||
Marketable securities: |
||||||||||||||||
Corporate debt securities due within |
( |
) | ||||||||||||||
Corporate debt securities due within (Level 2) |
( |
) | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total cash, cash equivalents and marketable securities |
$ | |
$ | $ | ( |
) | $ | |
||||||||
|
|
|
|
|
|
|
|
September 30, 2020 |
December 31, 2019 |
|||||||
Contract research organization costs |
$ | $ | ||||||
Other clinical study related costs |
||||||||
Compensation and benefits |
||||||||
Professional fees |
||||||||
Other |
||||||||
|
|
|
|
|||||
Total accrued liabilities |
$ | $ | ||||||
|
|
|
|
Shares |
Weighted average exercise price |
|||||||
Outstanding at January 1, 2020 |
$ | |||||||
Options granted |
||||||||
Options exercised |
( |
) | ||||||
Options cancelled |
( |
) | ||||||
|
|
|
|
|||||
Outstanding at September 30, 2020 |
$ | |||||||
|
|
|
|
|||||
Exercisable at September 30, 2020 |
$ |
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||||||||
Stock-based compensation expense by type of award: |
||||||||||||||||
Stock options |
$ | $ | $ | $ | ||||||||||||
Restricted stock |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total stock-based compensation expense |
$ | $ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
|
|
|
|
|
||||||||||||
Effect of stock-based compensation expense by line item: |
||||||||||||||||
Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total stock-based compensation expense included in net loss |
$ | $ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
• | salaries and related expense, including stock-based compensation; |
• | external expenses paid to clinical trial sites, contract research organizations, laboratories, database software 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 September 30, |
Increase / (Decrease) |
|||||||||||||||
2020 |
2019 |
$ |
% |
|||||||||||||
Research and Development Expenses |
$ | 53,292 | $ | 19,447 | 33,845 | 174 | % | |||||||||
General and Administrative Expenses |
5,494 | 4,748 | 746 | 16 | % | |||||||||||
Interest (Income) |
(823 | ) | (2,766 | ) | (1,943 | ) | (70 | %) | ||||||||
|
|
|
|
|||||||||||||
$ | 57,963 | 21,429 | 36,534 | 170 | % |
Nine Months Ended September 30, |
Increase / (Decrease) |
|||||||||||||||
2020 |
2019 |
$ |
% |
|||||||||||||
Research and Development Expenses |
$ | 131,380 | $ | 47,414 | 83,966 | 177 | % | |||||||||
General and Administrative Expenses |
15,738 | 17,604 | (1,866 | ) | (11 | %) | ||||||||||
Interest (Income) |
(3,897 | ) | (8,810 | ) | (4,913 | ) | (56 | %) | ||||||||
Other (income) |
(100 | ) | — | 100 | 100 | % | ||||||||||
|
|
|
|
|||||||||||||
$ | 143,121 | $ | 56,208 | 86,913 | 155 | % |
Nine Months Ended September 30, |
||||||||
2020 |
2019 |
|||||||
Net cash used in operating activities |
$ | (102,614 | ) | $ | (29,342 | ) | ||
Net cash provided by investing activities |
164,578 | 61,214 | ||||||
Net cash provided by financing activities |
459 | 235 | ||||||
|
|
|
|
|||||
Net increase in cash and cash equivalents |
$ | 62,423 | $ | 32,107 |
Exhibit |
Incorporated by Reference |
Filed |
||||||||||||||||||||
Number |
Exhibit Description |
Form |
File No. |
Exhibit |
Filing Date |
Herewith |
||||||||||||||||
31.1 | Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | X | ||||||||||||||||||||
31.2 | Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | X | ||||||||||||||||||||
32.1** | Certifications of Principal Executive Officer and Principal Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | X | ||||||||||||||||||||
101.INS | Inline XBRL Instance Document. | X | ||||||||||||||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document. | X | ||||||||||||||||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | X | ||||||||||||||||||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. | X | ||||||||||||||||||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | X | ||||||||||||||||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. | X | ||||||||||||||||||||
104 | Inline XBRL for the cover page of this Annual Report on Form 10-K, included in the Exhibit 101 Inline XBRL Document Set. |
* | Certain portions of this exhibit have been redacted in accordance with Item 601(b)(10) of Regulation S-K. |
** | The certifications attached as Exhibit 32.1 that accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, shall not be deemed “filed” by the registrant for purposes of Section 18 of the Exchange Act and are not to be incorporated by reference into any of the registrant’s filings under the Securities Act or the Exchange Act, irrespective of any general incorporation language contained in any such filing. |
MADRIGAL PHARMACEUTICALS, INC. | ||||||
Date: November 5, 2020 | By: | /s/ Paul A. Friedman, | ||||
M.D. Paul A. Friedman, | ||||||
M.D. Chief Executive Officer | ||||||
(Principal Executive Officer) | ||||||
Date: November 5, 2020 | By: | /s/ Marc R. Schneebaum | ||||
Marc R. Schneebaum | ||||||
Chief Financial Officer | ||||||
(Principal Financial and Accounting Officer) |