UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
For the quarterly period ended
OR
For the transition period from to
Commission File Number:
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Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, an emerging growth company, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of May 4, 2022, the registrant had
TABLE OF CONTENTS
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PART I. |
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Item 1. |
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6 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
16 |
Item 3. |
35 |
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Item 4. |
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PART II. |
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Item 1. |
36 |
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Item 1A. |
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Item 2. |
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Item 3. |
36 |
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Item 4. |
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Item 5. |
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Item 6. |
37 |
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38 |
i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. In this Quarterly Report on Form 10-Q, all statements, other than statements of historical or present facts, including statements regarding our future financial condition, future revenues, projected costs, prospects, business strategy, and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “believe,” “will,” “may,” “might,” “estimate,” “continue,” “anticipate,” “intend,” “target,” “project,” “model,” “should,” “would,” “plan,” “expect,” “predict,” “could,” “seek,” “goals,” “potential,” and similar terms or expressions that concern our expectations, strategy, plans, or intentions. These forward-looking statements include, but are not limited to, statements about:
1
Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by these forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
2
DEFINED TERMS
Unless the context requires otherwise, references to “Reata,” “the Company,” “we,” “us,” or “our” in this Quarterly Report on Form 10-Q refer to Reata Pharmaceuticals, Inc. and its subsidiaries. We also have used several other terms in this Quarterly Report on Form 10-Q, most of which are explained or defined below.
Abbreviated Term |
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Defined Term |
AbbVie |
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AbbVie Inc. |
ADPKD |
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Autosomal dominant polycystic kidney disease |
ADL |
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Activities of Daily Living |
AE |
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Adverse event |
ALS |
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Amyotrophic lateral sclerosis |
ATP |
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Adenosine triphosphate |
bardoxolone |
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Bardoxolone methyl |
BXLS |
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Blackstone Life Sciences, LLC |
CKD |
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Chronic kidney disease |
CMC |
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Chemistry manufacturing controls |
COVID-19 |
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Coronavirus disease |
CRL |
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Complete Response Letter |
CRO |
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Contract research organization |
DPNP |
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Diabetic peripheral neuropathic pain |
eGFR |
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Estimated glomerular filtration rate |
EMA |
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European Medicines Agency |
ESKD |
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End stage kidney disease |
Exchange Act |
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Securities Exchange Act of 1934 |
FA |
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Friedreich’s ataxia |
FDA |
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United States Food and Drug Administration |
GFR |
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Glomerular filtration rate |
Kyowa Kirin |
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Kyowa Kirin Co., Ltd. |
LTIP Plan |
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Second Amended and Restated Long Term Incentive Plan |
MAA |
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Marketing Authorization Application |
mFARS |
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Modified Friedreich’s Ataxia Rating Scale |
NDA |
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New Drug Application |
PGIC |
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Patient global impression of change |
PK |
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Pharmacokinetic |
Registrational trial |
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An adequate and well-controlled trial designed to be sufficient to apply for regulatory approval of a drug candidate, although notwithstanding the Company’s design a regulatory agency may determine that further clinical studies or data are required |
RSU |
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Restricted Stock Unit |
SAE |
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Serious adverse event |
SEC |
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U.S. Securities and Exchange Commission |
U.S. GAAP |
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Accounting principles generally accepted in the United States |
3
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements.
Reata Pharmaceuticals, Inc.
Consolidated Balance Sheets
(in thousands, except share data)
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March 31, 2022 |
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December 31, 2021 |
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(unaudited) |
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Assets |
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Cash and cash equivalents |
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$ |
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$ |
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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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Operating lease right-of-use-assets |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Accounts payable |
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Accrued direct research liabilities |
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Other current liabilities |
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Operating lease liabilities, current |
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Deferred revenue |
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Total current liabilities |
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Other long-term liabilities |
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Operating lease liabilities, noncurrent |
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Liability related to sale of future royalties, net |
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Total noncurrent liabilities |
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Stockholders’ equity: |
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Common stock A, $ |
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Common stock B, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes.
4
Reata Pharmaceuticals, Inc.
Unaudited Consolidated Statements of Operations
(in thousands, except share and per share data)
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Three Months Ended |
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March 31 |
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2022 |
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2021 |
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Collaboration revenue |
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License and milestone |
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$ |
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$ |
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Other revenue |
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Total collaboration revenue |
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Expenses |
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Research and development |
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General and administrative |
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Depreciation |
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Total expenses |
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Other income (expense), net |
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( |
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( |
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Loss before taxes on income |
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( |
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( |
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Benefit from (provision for) taxes on income |
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( |
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Net loss |
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$ |
( |
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$ |
( |
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Net loss per share—basic and diluted |
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$ |
( |
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$ |
( |
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Weighted-average number of common shares used in |
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See accompanying notes.
5
Reata Pharmaceuticals, Inc.
Unaudited Consolidated Statements of Stockholders’ Equity
(in thousands, except share and per share data)
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Three Months Ended March 31, 2022 |
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Common Stock A |
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Common Stock B |
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Additional |
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Total |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
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Balance at December 31, 2021 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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Compensation expense |
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— |
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— |
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— |
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— |
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— |
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Exercise of options |
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— |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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— |
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— |
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— |
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— |
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Conversion of common |
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— |
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( |
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— |
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— |
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— |
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— |
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Balance at March 31, 2022 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Three Months Ended March 31, 2021 |
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Common Stock A |
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Common Stock B |
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Additional |
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Total |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
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Balance at December 31, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Compensation expense |
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— |
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— |
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— |
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— |
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— |
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Exercise of options |
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— |
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— |
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— |
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— |
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Issuance of common stock upon |
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Conversion of common |
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— |
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( |
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— |
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— |
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— |
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— |
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Balance at March 31, 2021 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
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See accompanying notes.
6
Reata Pharmaceuticals, Inc.
Unaudited Consolidated Statements of Cash Flows
(in thousands)
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Three Months Ended |
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March 31 |
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2022 |
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2021 |
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Operating activities |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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Amortization of debt issuance costs and imputed interest |
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Non-cash interest expense on liability related to sale of future royalty |
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Stock-based compensation expense |
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Changes in operating assets and liabilities: |
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Income tax receivable and payable |
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( |
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Prepaid expenses, other current assets and other assets |
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Accounts payable |
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( |
) |
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Accrued direct research, other current and long-term liabilities |
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( |
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( |
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Operating lease obligations |
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Deferred revenue |
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( |
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( |
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Net cash used in operating activities |
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( |
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( |
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Investing activities |
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Purchases of property and equipment |
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( |
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( |
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Net cash used in investing activities |
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( |
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( |
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Financing activities |
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Exercise of options |
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Net cash provided by financing activities |
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Net decrease in cash and cash equivalents |
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( |
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( |
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Cash and cash equivalents at beginning of year |
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Cash and cash equivalents at end of period |
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$ |
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$ |
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Non-cash activity: |
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Right-of-use assets obtained in exchange for lease obligations |
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$ |
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$ |
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Purchases of equipment in accounts payable, accrued direct research, other current, and long-term liabilities |
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$ |
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$ |
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Acquisition of property and equipment through tenant improvement allowance |
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$ |
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$ |
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See accompanying notes.
7
Reata Pharmaceuticals, Inc.
Notes to Unaudited Consolidated Financial Statements
1. Description of Business
Reata Pharmaceuticals, Inc.’s (Reata, the Company, we, us, or our) mission is to identify, develop, and commercialize innovative therapies that change patients’ lives for the better. The Company focuses on small-molecule therapeutics with novel mechanisms of action for the treatment of severe, life-threatening diseases with few or no approved therapies. The Company’s lead programs are omaveloxolone in a rare neurological disease called Friedreich’s ataxia (FA) and bardoxolone methyl (bardoxolone) in rare forms of chronic kidney disease (CKD). Both of the Company’s lead product candidates activate the transcription factor Nrf2 to normalize mitochondrial function, restore redox balance, and resolve inflammation. Because mitochondrial dysfunction, oxidative stress, and inflammation are features of many diseases, the Company believes omaveloxolone, bardoxolone, and our next-generation Nrf2 activators have many potential clinical applications. Reata possesses exclusive, worldwide rights to develop, manufacture, and commercialize omaveloxolone, bardoxolone, and our next-generation Nrf2 activators, excluding certain Asian markets for bardoxolone in certain indications, which are licensed to Kyowa Kirin Co., Ltd. (Kyowa Kirin). In addition, we are developing RTA 901, the lead product candidate from our Hsp90 modulator program, in neurological indications. We are the exclusive licensee of RTA 901 and have worldwide commercial rights.
The Company’s consolidated financial statements include the accounts of all majority-owned subsidiaries. Accordingly, the Company’s share of net earnings and losses from these subsidiaries is included in the consolidated statements of operations. Intercompany profits, transactions, and balances have been eliminated in consolidation.
Prior period reclassifications
Certain prior period amounts in the consolidated financial statements have been reclassified to conform to the current period presentation. Specifically, Operating lease obligations have been reclassed out of Accrued direct research, other current and long-term liabilities in prior periods to conform with the current period presentation on the consolidated statements of cash flows.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three months ended March 31, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. The consolidated balance sheet at December 31, 2021, has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. For further information, refer to the annual consolidated financial statements and footnotes thereto of the Company.
Summary of Significant Accounting Policies
The significant accounting policies used in the preparation of these condensed consolidated financial statements for the three months ended March 31, 2022 are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
8
3. Collaboration Agreements
Subsequent to the 2019 reacquisition of certain rights originally licensed to AbbVie Inc. (AbbVie) (see AbbVie below), the Company’s collaboration revenue and deferred revenue have been generated primarily from licensing fees and reimbursements for expenses received under our exclusive license with Kyowa Kirin (the Kyowa Kirin Agreement).
Kyowa Kirin
In December 2009, the Company entered into an exclusive license with Kyowa Kirin to develop and commercialize bardoxolone in the licensed territory. The terms of the agreement include payment to the Company of a nonrefundable, up-front license fee of $
The up-front payment and regulatory milestones are accounted for as a single unit of accounting. The Company regularly evaluates its remaining performance obligation under the Kyowa Kirin Agreement. Accordingly, revenue may fluctuate from period to period due to changes to its estimated performance obligation period and variable considerations. The Company began recognizing revenue related to the up-front payment upon execution of the Kyowa Kirin Agreement.
In March 2021, the Company’s performance obligation period under the Kyowa Kirin Agreement was extended to June 2022 , which decreased quarterly revenue recognition by approximately $
On July 27, 2021, Kyowa Kirin submitted a New Drug Application (NDA) in Japan to the Ministry of Health, Labour and Welfare for bardoxolone for improvement of renal function in patients with Alport syndrome. Based on this submission, the Company earned a $
AbbVie
In September 2010, the Company entered into a license agreement with AbbVie (the AbbVie License Agreement) for an exclusive license to develop and commercialize bardoxolone in the Licensee Territory (as defined in the AbbVie License Agreement).
In December 2011, the Company entered into a collaboration agreement with AbbVie (the Collaboration Agreement) to jointly research, develop, and commercialize the Company’s portfolio of second and later generation oral Nrf2 activators.
In October 2019, the Company and AbbVie entered into an Amended and Restated License Agreement (the Reacquisition Agreement) pursuant to which the Company reacquired the development, manufacturing, and commercialization rights concerning its proprietary Nrf2 activator product platform originally licensed to AbbVie in the AbbVie License Agreement and the Collaboration Agreement. In exchange for such rights, the Company agreed to pay AbbVie $
9
The Company recognized interest expense related to the Reacquisition Agreement of approximately $
4. Liability Related to Sale of Future Royalties
On June 24, 2020, the Company closed on the Development and Commercialization Funding Agreement with an affiliate of Blackstone Life Sciences, LLC (BXLS), which provides funding for the development and commercialization of bardoxolone for the treatment of CKD caused by Alport syndrome, autosomal dominant polycystic kidney disease (ADPKD), and certain other rare CKD indications in return for future royalties (the Development Agreement). The Development Agreement includes a $
In addition, concurrent with the Development Agreement, the Company entered into a common stock purchase agreement (the Purchase Agreement) with affiliates of BXLS to sell an aggregate of
The Company concluded that there were
The following table shows the activity within the liability related to sale of future royalties for the three months ended March 31, 2022:
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Liability Related to Sale of Future Royalties |
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(in thousands) |
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Balance at December 31, 2021 |
$ |
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Non-cash interest expense recognized |
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Balance at March 31, 2022 |
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Less: Unamortized transaction cost |
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( |
) |
Carrying value at March 31, 2022 |
$ |
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10
5. Other Income (Expense), Net
|
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Three Months Ended |
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March 31 |
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2022 |
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2021 |
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(in thousands) |
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Other income (expense), net |
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Investment income |
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$ |
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$ |
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Interest expense |
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( |
) |
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Non-cash interest expense on liability |
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( |
) |
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( |
) |
Other income (expense) |
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( |
) |
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Total other income (expense), net |
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$ |
( |
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$ |
( |
) |
Investment Income
Interest income consists primarily of interest generated from our cash and cash equivalents.
Interest Expense
Interest expense consists primarily of the imputed interest from amount due to AbbVie under the Reacquisition Agreement.
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties
Non-cash interest expense consists of recognition of interest expense based on the Company’s current estimate of future royalties expensed to be paid over the estimated term of the Development Agreement.
Other Income (Expense)
Other income (expense) consists primarily of gains and losses on foreign currency exchange.
6. Leases
The Company headquarters is located in Plano, Texas, where it leases approximately
On February 4, 2022, the Company
On March 8, 2022, the Company
The Company has an additional lease of a single-tenant, build-to-suit building of approximately
11
For the three months ended March 31, 2022, the Company paid $
Supplemental balance sheet and other information related to the Company’s operating leases is as follows:
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|
|
|
As of March 31, |
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|||||
|
|
|
|
2022 |
|
|
2021 |
|
||
Weighted-average remaining lease term (in years) |
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|
|
|
|
|
||||
Weighted-average discount rate |
|
|
|
|
% |
|
|
% |
Maturities of lease liabilities by fiscal year for the Company’s operating leases:
|
|
As of March 31, 2022 |
|
|
|
|
(in thousands) |
|
|
2022 (remaining nine months) |
|
$ |
|
|
2023 (1) |
|
|
|
|
2024 |
|
|
|
|
2025 |
|
|
|
|
Thereafter |
|
|
|
|
Total lease payments (1) |
|
|
|
|
Less: Imputed interest |
|
|
( |
) |
Present value of lease liabilities |
|
$ |
|
7. Income Taxes
The following table summarizes income tax (benefit) expense and effective income tax rate:
|
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Three Months Ended |
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|||||
|
|
March 31 |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
|
|
(in thousands, except for percentage data) |
|
|||||
Benefit from (provision for) taxes on income |
|
$ |
( |
) |
|
$ |
|
|
Effective income tax rate |
|
|
% |
|
|
% |
The Company’s effective tax rate for the three months ended March 31, 2022, varies with the statutory rate primarily due to changes in the valuation allowance related to certain deferred tax assets generated or utilized in the applicable period.
Deferred tax assets are regularly reviewed for recoverability by jurisdiction and valuation allowances are established based on historical and projected future taxable losses and the expected timing of the reversals of existing temporary differences. The Company has recorded valuation allowances against the majority of its deferred tax assets as of March 31, 2022, and the Company expects to maintain these valuation allowances until there is sufficient evidence that future earnings can be achieved, which is uncertain at this time.
12
8. Stock-Based Compensation
The following table summarizes time-based and performance-based stock compensation expense reflected in the consolidated statements of operations:
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|
Three Months Ended |
|
|||||
|
|
March 31 |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
|
|
(in thousands) |
|
|||||
Research and development |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Total stock compensation expense |
|
$ |
|
|
$ |
|
Restricted Stock Units (RSUs)
The following table summarizes RSU activity as of March 31, 2022, under the Second Amended and Restated Long Term Incentive Plan (LTIP Plan) agreement:
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Number of |
|
|
Weighted-Average |
|
||
Outstanding at January 1, 2022 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Outstanding at March 31, 2022 |
|
|
|
|
$ |
|
As of March 31, 2022, total unrecognized compensation expense related to RSU and performance-based RSUs awards that were deemed probable of vesting was approximately $
Stock Options
The following table summarizes stock option activity as of March 31, 2022, under the LTIP Plan and standalone option agreements:
|
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Number of |
|
|
Weighted- |
|
||
Outstanding at January 1, 2022 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Exercised |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Expired |
|
|
( |
) |
|
|
|
|
Outstanding at March 31, 2022 |
|
|
|
|
$ |
|
||
Exercisable at March 31, 2022 |
|
|
|
|
$ |
|
As of March 31, 2022, total unrecognized compensation expense related to stock options was approximately $