Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 07, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-39614 | |
Entity Registrant Name | TARSUS PHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-4717861 | |
Entity Address, Address Line One | 15440 Laguna Canyon Road, Suite 160 | |
Entity Address, City or Town | Irvine | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92618 | |
City Area Code | (949) | |
Local Phone Number | 409-9820 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | TARS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Smaller Reporting Company | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,672,188 | |
Amendment Flag | false | |
Entity Central Index Key | 0001819790 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Fair value of cash and cash equivalents | $ 169,489 | $ 171,332 |
Marketable securities | 57,083 | 483 |
Accounts receivable | 17 | 0 |
Other receivables | 3,995 | 92 |
Prepaid expenses | 3,494 | 4,045 |
Total current assets | 234,078 | 175,952 |
Property and equipment, net | 951 | 755 |
Operating lease right-of-use assets | 696 | 1,074 |
Long-term investments | 157 | 0 |
Other assets | 583 | 1,126 |
Total assets | 236,465 | 178,907 |
Current liabilities: | ||
Accounts payable and other accrued liabilities | 10,181 | 8,680 |
Accrued payroll and benefits | 4,092 | 2,798 |
Total current liabilities | 14,273 | 11,478 |
Term loan, net | 19,356 | 0 |
Other long-term liabilities | 209 | 699 |
Total liabilities | 33,838 | 12,177 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 authorized; no shares issued and outstanding | 0 | 0 |
Common stock, $0.0001 par value; 200,000,000 shares authorized; 26,671,812 shares issued and outstanding at September 30, 2022 (unaudited); 20,726,580 shares issued and 20,698,737 outstanding, which excludes 27,840 shares subject to repurchase at December 31, 2021 | 5 | 4 |
Additional paid-in capital | 297,796 | 213,398 |
Accumulated deficit | (10) | 0 |
Accumulated deficit | (95,164) | (46,672) |
Total stockholders’ equity | 202,627 | 166,730 |
Total liabilities and stockholders’ equity | $ 236,465 | $ 178,907 |
Common stock, outstanding (shares) | 26,671,812 | 20,698,737 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized (shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (shares) | 0 | 0 |
Preferred stock, outstanding (shares) | 0 | 0 |
Common stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized (shares) | 200,000,000 | 200,000,000 |
Common stock, issued (shares) | 26,671,812 | 20,726,580 |
Common stock, outstanding (shares) | 26,671,812 | 20,698,737 |
Common stock, subject to repurchase (shares) | 27,840 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive (Loss) Income - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues: | ||||
Total revenues | $ 0 | $ 1,240 | $ 15,816 | $ 56,689 |
Operating expenses: | ||||
Cost of license fees and collaboration revenue | 0 | 65 | 555 | 2,099 |
Research and development | 10,912 | 10,209 | 32,596 | 33,674 |
General and administrative | 11,994 | 6,671 | 30,316 | 18,625 |
Total operating expenses | 22,906 | 16,945 | 63,467 | 54,398 |
(Loss) income from operations before other income (expense) and income taxes | (22,906) | (15,705) | (47,651) | 2,291 |
Other income (expense): | ||||
Interest income | 1,061 | 8 | 1,372 | 24 |
Interest expense | (633) | 0 | (1,507) | 0 |
Other (expense) income, net | (7) | 5 | 136 | (68) |
Unrealized loss on equity investments | (13) | 0 | (326) | 0 |
Change in fair value of equity warrants issued by licensee | (18) | (346) | (520) | (1,222) |
Total other income (expense), net | 390 | (333) | (845) | (1,266) |
Benefit (provision) for income taxes | 5 | 341 | 4 | (1) |
Net (loss) income | (22,511) | (15,697) | (48,492) | 1,024 |
Other comprehensive (loss) income: | ||||
Unrealized loss on marketable securities and cash equivalents | (10) | 0 | (10) | 0 |
Comprehensive (loss) income | $ (22,521) | $ (15,697) | $ (48,502) | $ 1,024 |
Earnings Per Share [Abstract] | ||||
Net (loss) per share, basic (usd per share) | $ (0.84) | $ (0.76) | $ (2.03) | $ 0.05 |
Net (loss) income per share, diluted (usd per share) | $ (0.84) | $ (0.76) | $ (2.03) | $ 0.05 |
Weighted Average Number of Shares Outstanding, Diluted [Abstract] | ||||
Weighted-average shares outstanding, basic (shares) | 26,662,374 | 20,641,285 | 23,923,512 | 20,511,973 |
Weighted-average shares outstanding, diluted (shares) | 26,662,374 | 20,641,285 | 23,923,512 | 22,032,487 |
License fees | ||||
Revenues: | ||||
Total revenues | $ 0 | $ 708 | $ 13,893 | $ 53,067 |
Collaboration revenue | ||||
Revenues: | ||||
Total revenues | $ 0 | $ 532 | $ 1,923 | $ 3,622 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (shares) at Dec. 31, 2020 | 0 | ||||
Ending balance (shares) at Mar. 31, 2021 | 0 | ||||
Beginning balance at Dec. 31, 2020 | $ 0 | ||||
Ending balance at Mar. 31, 2021 | 0 | ||||
Beginning balance (shares) at Dec. 31, 2020 | 20,323,201 | ||||
Beginning balance at Dec. 31, 2020 | 165,980 | $ 4 | $ 198,821 | $ (32,845) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net (loss) income | 10,376 | 10,376 | |||
Recognition of stock-based compensation expense | 1,363 | 1,363 | |||
Exercise of vested stock options (shares) | 13,773 | ||||
Exercise of vested stock options | 19 | 19 | |||
Shares issued as consideration for in-license rights (shares) | 187,500 | ||||
Shares issued as consideration for in-license rights | 5,494 | 5,494 | |||
Ending balance (shares) at Mar. 31, 2021 | 20,524,474 | ||||
Ending balance at Mar. 31, 2021 | $ 183,232 | $ 4 | 205,697 | (22,469) | |
Beginning balance (shares) at Dec. 31, 2020 | 0 | ||||
Ending balance (shares) at Sep. 30, 2021 | 0 | ||||
Beginning balance at Dec. 31, 2020 | $ 0 | ||||
Ending balance at Sep. 30, 2021 | 0 | ||||
Beginning balance (shares) at Dec. 31, 2020 | 20,323,201 | ||||
Beginning balance at Dec. 31, 2020 | 165,980 | $ 4 | 198,821 | (32,845) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net (loss) income | 1,024 | ||||
Shares issued as consideration for in-license rights | 5,494 | ||||
Ending balance (shares) at Sep. 30, 2021 | 20,671,079 | ||||
Ending balance at Sep. 30, 2021 | $ 179,142 | $ 4 | 210,959 | (31,821) | |
Beginning balance (shares) at Mar. 31, 2021 | 0 | ||||
Ending balance (shares) at Jun. 30, 2021 | 0 | ||||
Beginning balance at Mar. 31, 2021 | $ 0 | ||||
Ending balance at Jun. 30, 2021 | 0 | ||||
Beginning balance (shares) at Mar. 31, 2021 | 20,524,474 | ||||
Beginning balance at Mar. 31, 2021 | 183,232 | $ 4 | 205,697 | (22,469) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net (loss) income | 6,345 | 6,345 | |||
Recognition of stock-based compensation expense | 2,794 | 2,794 | |||
Exercise of vested stock options (shares) | 255 | ||||
Exercise of vested stock options | 1 | 1 | |||
Lapse of repurchase obligation for stock option exercises, prior to vesting (shares) | 49,222 | ||||
Lapse of repurchase obligation for stock option exercises, prior to vesting | 99 | 99 | |||
Ending balance (shares) at Jun. 30, 2021 | 20,573,951 | ||||
Ending balance at Jun. 30, 2021 | $ 192,471 | $ 4 | 208,591 | (16,124) | |
Ending balance (shares) at Sep. 30, 2021 | 0 | ||||
Ending balance at Sep. 30, 2021 | $ 0 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net (loss) income | (15,697) | (15,697) | |||
Recognition of stock-based compensation expense | 2,119 | 2,119 | |||
Exercise of vested stock options (shares) | 87,004 | ||||
Exercise of vested stock options | 174 | 174 | |||
Shares issued as consideration for in-license rights (shares) | 10,124 | ||||
Shares issued as consideration for in-license rights | 75 | ||||
Ending balance (shares) at Sep. 30, 2021 | 20,671,079 | ||||
Ending balance at Sep. 30, 2021 | $ 179,142 | $ 4 | 210,959 | (31,821) | |
Beginning balance (shares) at Dec. 31, 2021 | 0 | ||||
Ending balance (shares) at Mar. 31, 2022 | 0 | ||||
Beginning balance at Dec. 31, 2021 | $ 0 | ||||
Ending balance at Mar. 31, 2022 | $ 0 | ||||
Beginning balance (shares) at Dec. 31, 2021 | 20,698,737 | 20,698,737 | |||
Beginning balance at Dec. 31, 2021 | $ 166,730 | $ 4 | 213,398 | $ 0 | (46,672) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net (loss) income | (20,238) | (20,238) | |||
Recognition of stock-based compensation expense | 2,674 | 2,674 | |||
Exercise of vested stock options (shares) | 225 | ||||
Issuance of common stock upon the vesting of restricted stock units (shares) | 4,257 | ||||
Lapse of repurchase obligation for stock option exercises, prior to vesting (shares) | 15,309 | ||||
Lapse of repurchase obligation for stock option exercises, prior to vesting | 31 | 31 | |||
Ending balance (shares) at Mar. 31, 2022 | 20,718,528 | ||||
Ending balance at Mar. 31, 2022 | $ 149,197 | $ 4 | 216,103 | 0 | (66,910) |
Beginning balance (shares) at Dec. 31, 2021 | 0 | ||||
Ending balance (shares) at Sep. 30, 2022 | 0 | ||||
Beginning balance at Dec. 31, 2021 | $ 0 | ||||
Ending balance at Sep. 30, 2022 | $ 0 | ||||
Beginning balance (shares) at Dec. 31, 2021 | 20,698,737 | 20,698,737 | |||
Beginning balance at Dec. 31, 2021 | $ 166,730 | $ 4 | 213,398 | 0 | (46,672) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net (loss) income | (48,492) | ||||
Shares issued as consideration for in-license rights | $ 0 | ||||
Ending balance (shares) at Sep. 30, 2022 | 26,671,812 | 26,671,812 | |||
Ending balance at Sep. 30, 2022 | $ 202,627 | $ 5 | 297,796 | (10) | (95,164) |
Beginning balance (shares) at Mar. 31, 2022 | 0 | ||||
Ending balance (shares) at Jun. 30, 2022 | 0 | ||||
Beginning balance at Mar. 31, 2022 | $ 0 | ||||
Ending balance at Jun. 30, 2022 | 0 | ||||
Beginning balance (shares) at Mar. 31, 2022 | 20,718,528 | ||||
Beginning balance at Mar. 31, 2022 | 149,197 | $ 4 | 216,103 | 0 | (66,910) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net (loss) income | (5,743) | (5,743) | |||
Recognition of stock-based compensation expense | 3,532 | 3,532 | |||
Exercise of vested stock options (shares) | 7,056 | ||||
Exercise of vested stock options | 17 | 17 | |||
Issuance of common stock upon the vesting of restricted stock units (shares) | 4,257 | ||||
Lapse of repurchase obligation for stock option exercises, prior to vesting (shares) | 6,705 | ||||
Lapse of repurchase obligation for stock option exercises, prior to vesting | 13 | 13 | |||
Issuance of common stock upon follow-up public offering, net of issuance costs (shares) | 5,889,832 | ||||
Issuance of common stock upon follow-on public offering, net of issuance costs of $5,246 | 74,267 | $ 1 | 74,266 | ||
Shares issued in connection with the employee stock purchase plan (shares) | 17,874 | ||||
Shares issued in connection with the employee stock purchase plan | 222 | 222 | |||
Ending balance (shares) at Jun. 30, 2022 | 26,644,252 | ||||
Ending balance at Jun. 30, 2022 | $ 221,505 | $ 5 | 294,153 | 0 | (72,653) |
Ending balance (shares) at Sep. 30, 2022 | 0 | ||||
Ending balance at Sep. 30, 2022 | $ 0 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net (loss) income | (22,511) | (22,511) | |||
Recognition of stock-based compensation expense | 3,583 | 3,583 | |||
Exercise of vested stock options (shares) | 21,734 | ||||
Exercise of vested stock options | 82 | 82 | |||
Issuance costs | 34 | 34 | |||
Unrealized loss on marketable securities and cash equivalents | (10) | (10) | |||
Lapse of repurchase obligation for stock option exercises, prior to vesting (shares) | 5,826 | ||||
Lapse of repurchase obligation for stock option exercises, prior to vesting | $ 12 | 12 | |||
Ending balance (shares) at Sep. 30, 2022 | 26,671,812 | 26,671,812 | |||
Ending balance at Sep. 30, 2022 | $ 202,627 | $ 5 | $ 297,796 | $ (10) | $ (95,164) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash Flows From Operating Activities: | ||
Net (loss) income | $ (48,492) | $ 1,024 |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | ||
Depreciation and amortization | 227 | 272 |
Accretion of term loan-related costs | 231 | 0 |
Stock-based compensation | 9,789 | 6,276 |
Non-cash lease expense | 343 | 178 |
Loss on disposal of property and equipment | 0 | 70 |
Loss on lease termination | 0 | 2 |
Unrealized loss on equity investments | 326 | 0 |
Amortization of discount on available-for-sale debt securities | (63) | 0 |
Change in fair value of equity warrants issued by licensee | 520 | 1,222 |
Unrealized gain from transactions denominated in a foreign currency | (1) | (4) |
Issuance of common stock upon in-license agreement milestone achievement | 0 | 5,494 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (17) | 0 |
Other receivables | (3,902) | (119) |
Prepaid expenses | 551 | (663) |
Other non-current assets | (75) | (2,762) |
Accounts payable and other accrued liabilities | 1,187 | 3,523 |
Accrued payroll and benefits | 1,294 | 1,206 |
Other long-term liabilities | (74) | 150 |
Net cash (used in) provided by operating activities | (38,156) | 15,869 |
Cash Flows From Investing Activities: | ||
Purchases of marketable securities | (57,031) | 0 |
Purchases of property and equipment | (379) | (312) |
Cash used in investing activities | (57,410) | (312) |
Cash Flows From Financing Activities: | ||
Proceeds from issuance of common stock upon follow-on public offering, net of paid issuance costs | 74,352 | 0 |
Proceeds from sale of common stock under employee stock purchase plan | 222 | 0 |
Proceeds from exercise of vested stock options | 99 | 95 |
Payment of deferred offering costs | (75) | 0 |
Proceeds from term loan | 20,000 | 0 |
Payment of term loan issuance costs | (875) | 0 |
Net cash provided by financing activities | 93,723 | 95 |
Net (decrease) increase in cash and cash equivalents | (1,843) | 15,652 |
Cash and cash equivalents — beginning of period | 171,332 | 168,149 |
Cash and cash equivalents — end of period | 169,489 | 183,801 |
Supplemental Disclosures Noncash Investing and Financing Activities: | ||
"Operating lease right-of-use asset" obtained in exchange for operating lease liability | 0 | 741 |
"Interest expense" paid in cash | 1,094 | 0 |
Additions of "property and equipment, net" included within "accounts payable and other accrued liabilities" | 44 | 0 |
Expensing of "operating lease right-of-use assets" upon lease termination | 0 | (38) |
Stock issued for in-license agreements included within "research and development" expense | $ 0 | $ 5,494 |
Condensed Statements of Stock_2
Condensed Statements of Stockholders' Equity (Parenthetical) $ in Thousands | 3 Months Ended |
Jun. 30, 2022 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Issuance costs related to follow-on public offering | $ 5,246 |
Description of Business and Pre
Description of Business and Presentation of Financial Statements | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Presentation of Financial Statements | DESCRIPTION OF BUSINESS AND PRESENTATION OF FINANCIAL STATEMENTS (a) Description of Business Tarsus Pharmaceuticals, Inc. (“Tarsus” or the “Company”) is a biopharmaceutical company focused on the development and commercialization of therapeutics, starting with eye care. (b) Liquidity Risk Overview The Company has no product sales and has accumulated losses and negative cash flows from operations since inception. The Company has funded its inception-to-date operations through equity capital raises, proceeds from its out-license agreement, and a draw on its credit facility. The Company estimates its existing capital resources will be sufficient to meet projected operating expense requirements for at least 12 months from the filing date of the accompanying Condensed Financial Statements in this Form 10-Q; accordingly, these financial statements have been prepared on a "going-concern" basis. The Company’s operations currently consist of its preclinical and clinical studies, corporate administration build-out to support its planned business growth, commercial leadership build-out in anticipation of the potential approval of TP-03 by the FDA in 2023 (see Note 11) , and in/out-licensing activities. The Company faces the clinical, business, and liquidity risks that are typically associated with biopharma companies. It must significantly invest in and conduct research and development activities with inherently uncertain outcomes, recruit and retain skilled personnel (including executive management), and expand and defend its intellectual property rights. Management expects the Company to continue to incur operating losses for the foreseeable future and may be required to raise additional capital to fund its ongoing operations. However, no assurance can be given as to whether financing will be available on terms acceptable to the Company, or at all. If the Company raises additional funds by issuing equity securities, its stockholders may experience significant dilution. The Company's credit facility imposes certain covenants that limit its ability to incur liens or secure additional debt financing, pay dividends, repurchase common stock, make certain investments, or engage in certain merger or asset sale transactions. Any new debt financing or additional equity raise may contain additional terms that are not favorable to the Company or its stockholders. The Company’s potential inability to raise capital when needed could have a negative impact on its financial condition and ability to pursue planned business strategies. If the Company is unable to raise additional funds as required, it may need to delay, reduce, or terminate some or all of its development programs and clinical trials. The Company may also be required to sell or license its rights to product candidates in certain territories or indications that it would otherwise prefer to develop and commercialize on its own and/or enter into collaborations and other arrangements to address its liquidity needs which could materially and adversely affect its business and financial prospects, or even its ability to remain a going concern. (c) Operating Segment To date, the Company has operated and managed its business and financial information on an aggregate basis based on its organizational structure, for the purposes of evaluating financial performance and the allocation of capital and personnel resources, consistent with the way operations and investments are centrally managed and evaluated. Accordingly, the Company’s management determined that it operates one reportable operating segment. This single segment is focused exclusively on developing pharmaceutical products for eventual commercialization. (d) Emerging Growth Company Status The Company is an "emerging growth company," as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has irrevocably elected to not take this exemption. As a result, it will adopt new or revised accounting standards on the relevant effective dates on which adoption of such standards is required for other public companies that are not emerging growth companies. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Use of Estimates | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Use of Estimates | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES (i) Basis of Presentation The Company’s Condensed Financial Statements have been prepared in conformity with generally accepted accounting principles ("GAAP") in the United States ("U.S.") for interim financial information and pursuant to Form 10-Q and with the rules and regulations of the Securities and Exchange Commission ("SEC"). Accordingly, the accompanying Condensed Financial Statements do not include all of the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the audited financial statements and the related notes thereto in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 14, 2022. The interim Condensed Balance Sheet as of September 30, 2022, the interim Condensed Statements of Operations and Comprehensive (Loss) Income, and the interim Condensed Statements of Stockholders’ Equity for the three and nine months ended September 30, 2022 and 2021, and the interim Condensed Statements of Cash Flows for the nine months ended September 30, 2022 and 2021 are unaudited. These unaudited interim financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, which consist of only normal and recurring adjustments for the fair presentation of its financial information. The financial data and other information disclosed in these notes related to the three and nine-month periods are also unaudited. The Condensed Balance Sheet as of December 31, 2021 has been derived from the audited financial statements at that date but does not include all information and footnotes required by GAAP for annual financial statements. The condensed interim operating results for three and nine months ended September 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022 or any other interim or annual period. The preparation of financial statements in conformity with GAAP and with the rules and regulations of the SEC requires management to make informed estimates and assumptions that affect the amounts reported in these financial statements and accompanying notes. These estimates and assumptions involve judgments with respect to numerous factors that are difficult to forecast and may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. There have been no significant changes in the Company’s significant accounting policies during the three and nine months ended September 30, 2022, as compared with those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 14, 2022, except as discussed below. The accounting policies and estimates that most significantly impact the presented amounts within the accompanying Condensed Financial Statements are further described below. (ii) Cash and Cash Equivalents Cash and cash equivalents consist of bank deposits and highly liquid investments, including money market fund accounts, that are readily convertible into cash without penalty, with original maturities of three months or less from the purchase date. (iii) Marketable Securities and Long-Term Investments As of September 30, 2022, marketable securities consist of short term fixed income investments that have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities (see Note 7 ). Management determines the appropriate classification of its investments in fixed income securities at the time of purchase. Available-for-sale securities are classified as current assets on the accompanying Condensed Balance Sheets due to their highly liquid nature and availability for use in current operations. Marketable securities are recorded at fair value with unrealized losses and gains reported as a component of "accumulated other comprehensive loss" within the Condensed Statements of Stockholders' Equity until realized. The Company periodically evaluates whether declines in fair values of its available-for-sale securities below their book value are other-than-temporary. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale securities before recovery of its amortized cost basis. The cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion, as well as interest and dividends, are included in interest income. Realized losses and gains as well as credit losses, if any, on marketable securities identified on a specific identification basis and are included in "other income (expense), net" on the accompanying Condensed Statement of Operations. The Company evaluated the underlying credit quality and credit ratings of the issuers during the period. To date, the Company has not identified any other than temporary declines in fair value of its investments and no credit losses have occurred or have been recorded. Interest earned on marketable securities is included in "interest income" within the accompanying Condensed Statement of Operations. As of December 31, 2021, marketable securities consisted of holdings of LianBio common stock. These shares are reported within "long-term investments" on the accompanying Condensed Balance Sheet as of September 30, 2022, reflecting the intent to hold these shares for at least one year from the balance sheet date. These equity securities are designated as "available-for-sale" with associated gains or losses reported in "other income (expense), net" within the Condensed Statements of Operations and Comprehensive (Loss) Income for each reported period. (iv) Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. Management believes the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company’s results of operations involve numerous risks and uncertainties. Factors that could adversely impact the Company’s operating results and business objectives include, but are not limited to, (1) uncertainty of results of clinical trials, (2) uncertainty of regulatory approval of the Company’s potential product candidates, (3) uncertainty of market acceptance of its product candidates, (4) competition from substitute products and other companies, (5) securing and protecting proprietary technology and strategic relationships, and (6) dependence on key individuals and sole source suppliers. The Company’s product candidates require approvals from the U.S. Food and Drug Administration (“FDA”) and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed, or the Company is unable to maintain approval for any product candidate, it could have a materially adverse impact on its business. (v) Revenue Recognition for Out-License Arrangements Overview The Company currently has no product revenue. Reported revenue in the accompanying Statements of Operations and Comprehensive (Loss) Income is associated with one out-license agreement (the "China Out-License") that allows the third-party licensee to market the Company's TP-03 product candidate (representing "functional intellectual property") in the People's Republic of China, Hong Kong, Macau, and Taiwan (the "China territory") - see Note 9 . The accounting and reporting of revenue for out-license arrangements requires significant judgment for: (a) identification of the number of performance obligations within the contract, (b) the contract’s transaction price for allocation (including variable consideration), (c) the stand-alone selling price for each identified performance obligation, and (d) the timing and amount of revenue recognition in each period. The China Out-License was analyzed under GAAP to determine whether the promised goods or services are distinct, or in the alternative, must be accounted for as part of a combined performance obligation. In making these assessments, the Company considers factors such as the stage of development of the underlying intellectual property and the capabilities of the customer to develop the intellectual property on their own, and/or whether the required expertise is readily available. If the license is considered to not be distinct, the license is combined with other promised goods or services as a combined performance obligation for revenue recognition. The China Out-License includes the following forms of consideration: (i) non-refundable upfront license payments, (ii) equity securities and warrants, (iii) sales-based royalties, (iv) sales threshold milestones, (v) development milestone payments, and (vi) regulatory milestone payments. Revenue is recognized in proportion to the allocated transaction price when (or as) the respective performance obligation is satisfied. The Company evaluates the progress related to each milestone at each reporting period and, if necessary, also adjusts the probability of achievement and related revenue recognition. The measure of progress, and thereby periods over which revenue is recognized, is subject to estimates by management and may change over the course of the respective agreement. Contractual Terms for Receipt of Payments The contractual terms that establish the Company’s right to collect specified amounts from its customers and that require contemporaneous evaluation and documentation under GAAP for the corresponding timing and amount of revenue recognition, are as follows: (1) Upfront License Fees: The Company determines whether non-refundable license fee consideration is recognized at the time of contract execution (i.e., when the license is transferred to the customer and the customer is able to use and benefit from the license) or over the actual (or implied) contractual period of the China Out-License. The Company also evaluates whether it has any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer to determine whether any combined performance obligation is satisfied over time or at a point in time. Upfront payments may require deferral of revenue recognition to a future period until the Company performs obligations under these arrangements. (2) Development Milestones: The Company utilizes the “most likely amount” method to estimate the amount of consideration to which it will be entitled for achievement of development milestones as these represent variable consideration. For those payments based on development milestones (e.g., patient dosing in a clinical study or the achievement of statistically significant clinical results), the Company assesses the probability that the milestone will be achieved, including its ability to control the timing or likelihood of achievement, and any associated revenue constraint. Given the high degree of uncertainty around the occurrence of these events, the Company determines the milestone and other contingent amounts to be "constrained" until the uncertainty associated with these payments is resolved. At each reporting period, the Company re-evaluates this associated revenue recognition constraint. Any resulting adjustments are recorded to revenue on a cumulative catch-up basis, and reflected in the financial statements in the period of adjustment. (3) Regulatory Milestones: The Company utilizes the “most likely amount” method to estimate the consideration to which it will be entitled and recognizes revenue in the period regulatory approval occurs (the performance obligation is satisfied) as these represent variable consideration. Amounts constrained as variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company evaluates whether the milestones are considered probable of being reached and not otherwise "constrained." Accordingly, due to the inherent uncertainty of achieving regulatory approval, associated milestones are deemed constrained for revenue recognition until achievement. (4) Royalties: Under the "sales-or-usage-based royalty exception" the Company recognizes revenue based on the contractual percentage of the licensee’s sale of products to its customers at the later of (i) the occurrence of the related product sales or (ii) the date upon which the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue from its out-licensing arrangement. (5) Sales Threshold Milestones: Similar to royalties, applying the "sales-or-usage-based royalty exception", the Company recognizes revenue from sales threshold milestones at the later of (i) the period the licensee achieves the one-time annual product sales levels in their territories for which the Company is contractually entitled to a specified lump-sum receipt, or (ii) the date upon which the performance obligation to which some or all of the milestone has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any sales threshold milestone revenue from the out-licensing arrangement. The Company re-evaluates the measure of progress to each performance obligation in each reporting period as uncertain events are resolved and other changes in circumstances occur. A "performance obligation" is a promise in a contract to transfer a distinct good or service and is the unit of accounting. A contract’s "transaction price" is allocated among each distinct performance obligation based on relative standalone selling price and recognized when, or as, the applicable performance obligation is satisfied. (vi) Research and Development Costs Research and development costs are expensed as incurred or as certain upfront or milestone payments become contractually due to licensors upon the achievement of clinical or regulatory events. These expenses also include internal costs directly attributable to in-development programs, including cost of certain salaries, payroll taxes, employee benefits, and stock-based compensation expense, as well as laboratory and clinical supplies, pre-clinical and clinical trial expenses, manufacturing costs for drug products before FDA approval, and the costs of various research and development contractors. Expenses for pre-clinical studies and clinical trial activities that are performed by third parties on behalf of the Company are typically based upon estimates of the proportion of work completed over the term of the individual study or trial, as well as patient enrollment and dosing events. These costs are in accordance with the agreements established with the contracted clinical research organizations and associated trial sites. The Company has entered, and may continue to enter into, license agreements to access and utilize intellectual property for drug development. In each case, the Company evaluates if the assets acquired in a transaction represent the acquisition of an "as set" or a "business" as defined under applicable GAAP. The Company’s executed in-license agreements (see Note 8 (b) ) were evaluated and determined to represent "asset" acquisitions. Because these assets have not yet received regulatory approval and have no alternative future use, the purchase price for each was immediately recognized as "research and development" expense in the accompanying financial statements. In addition, any future milestone payments (whether in the form of cash or stock) made before product regulatory approval (that do not meet the definition of a "derivative") will also be immediately recognized as "research and development" expense when it becomes payable, provided there is no alternative future use in other research and development projects for its capitalization. (vii) Stock-Based Compensation The Company recognizes stock-based compensation expense for equity awards granted to employees, consultants, and members of its Board of Directors. The Black-Scholes pricing model is used to estimate the fair value of stock option awards as of the date of grant. The fair value of restricted stock units is representative of the closing share price preceding the date of grant. For stock-based awards that vest subject to the satisfaction of a service requirement, the related expense is recognized on a straight-line basis over each award’s actual or implied vesting period. For stock-based awards that vest subject to a performance condition, the Company recognizes related expense on an accelerated attribution method, if and when it concludes that it is highly probable that the performance condition will be achieved. As applicable, the Company reverses previously recognized expense for unvested awards in the same period of forfeiture. The measurement of the fair value of stock option awards and recognition of stock-based compensation expense requires assumptions to be estimated by management that involve inherent uncertainties and the application of management’s judgment, including (a) the fair value of the Company’s common stock on the date of the option grant, (b) the expected term of the stock option until its exercise by the recipient, (c) stock price volatility over the expected term, (d) the prevailing risk-free interest rate over the expected term, and (e) expected dividend payments over the expected term. Management estimates the expected term of awarded stock options utilizing the “simplified method” for awards since the Company does not yet have sufficient exercise history since its November 2016 corporate formation and also lacks specific historical and implied stock volatility information. Accordingly, management estimates this expected volatility based on a designated peer-group of publicly-traded companies for a look-back period (from the date of grant) that corresponds with the expected term of the awarded stock option. The Company estimates the risk-free interest rate based upon the U.S. Department of the Treasury yield curve in effect at award grant for time period that corresponds with the expected term of the awarded stock option. The Company’s expected dividend yield is zero because it has never paid cash dividends and does not expect to for the foreseeable future. The fair value of the Company’s common stock is based on the closing quoted market price of its common stock as reported by the Nasdaq Global Select Market on the date of grant. All stock-based compensation expense is reported in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income within "research and development" expense or "general and administrative" expense, based upon the assigned department of the award recipient. (viii) Net (Loss) Income per Share Basic net (loss) income per share is calculated by dividing the net (loss) income by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive shares of common stock. Diluted net (loss) income per share is computed by dividing the net (loss) income by the weighted-average number of common stock equivalents outstanding for the period determined using the "treasury-stock method" and "if-converted method" as applicable. The Company’s "participating securities" include unvested common stock awards issued upon early exercise of certain stock options, as early exercised unvested common stock awards have a non-forfeitable right to dividends. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses, so in periods of net losses, the "two-class method" of calculating basic and diluted earnings per share is not required. In periods of net income, basic and diluted net loss per share attributable to common stockholders is presented in conformity with the two-class method required for participating securities. Also, net income is attributed to both common stockholders and participating security holders, and therefore, net income is allocated to shares of common stock and participating securities, as if all of the earnings for the period had been distributed. Diluted earnings per share under the two-class method is calculated using the more dilutive of the treasury stock or the two-class method. Due to a net loss for the three and nine months ended September 30, 2022, all otherwise potentially dilutive securities are antidilutive, and accordingly, the reported basic net loss per share equals the reported diluted net loss per share in this period. (ix) Fair Value Measurements Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: • Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. • Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. • 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 carrying amounts for financial instruments consisting of cash and cash equivalents, accounts payable and accrued liabilities approximate fair value due to the short maturities for each. The Company's equity warrant holdings are carried at fair value based on unobservable market inputs (see Note 7 ). Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value hierarchy during the years presented. (x) Comprehensive (Loss) Income Comprehensive (loss) income represents (i) net loss or income for the periods presented, and (ii) unrealized gains or losses on our reported available-for-sale debt securities. (xi) Recently Issued or Effective Accounting Standards Recently issued or effective accounting pronouncements that impact, or may have an impact, on the Company’s financial statements have been discussed within the footnote to which each relates. Other recent accounting pronouncements not disclosed in these Condensed Financial Statements have been determined by the Company’s management to have no impact, or an immaterial impact, on its current and expected future financial position, results of operations, or cash flows. |
Balance Sheet Account Detail
Balance Sheet Account Detail | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Account Detail | BALANCE SHEET ACCOUNT DETAIL The composition of selected captions within the accompanying Condensed Balance Sheets are summarized below: (a) Prepaid Expenses “Prepaid expenses” consists of the following: September 30, 2022 December 31, 2021 Other prepaid expenses $ 3,430 $ 2,832 Prepaid insurance 64 1,213 Prepaid expenses $ 3,494 $ 4,045 (b) Other Receivables “Other receivables” consists of the following: September 30, 2022 December 31, 2021 PDUFA Fee reimbursement (1) $ 3,117 $ — R&D payroll tax receivable 340 90 Clinical receivables 292 — Interest receivable 198 2 Income tax receivable 48 — Other receivables $ 3,995 $ 92 (1) This amount represents the required FDA filing fee upon the Company's submission of its New Drug Application ("NDA") for TP-03 in the third quarter of 2022. This fee is expected to be refunded in full, based on the Company's status as a qualified "Small Business" as defined in the relevant Federal statute. (c) Property and Equipment, Net “Property and equipment, net” consists of the following: September 30, 2022 December 31, 2021 Furniture and fixtures $ 632 $ 596 Office equipment 197 84 Laboratory equipment 167 167 Leasehold improvements 403 129 Property and equipment, at cost 1,399 976 (Less): Accumulated depreciation and amortization 448 221 Property and equipment, net $ 951 $ 755 Depreciation expense (included within “total operating expenses” in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income) for the three months ended September 30, 2022 and 2021 was $0.1 million and $0.1 million, respectively, and for the nine months ended September 30, 2022 and 2021 was $0.2 million and $0.3 million, respectively. (d) Other Assets "Other assets" consists of the following: September 30, 2022 December 31, 2021 Deposits $ 71 $ 71 Equity warrants issued by licensee ( Note 7 ) 246 663 Other non-current assets 266 392 Other assets $ 583 $ 1,126 (e) Accounts Payable and Other Accrued Liabilities “Accounts payable and other accrued liabilities” consists of the following: September 30, 2022 December 31, 2021 Trade accounts payable and other $ 5,592 $ 2,856 Operating lease liability, current 572 609 Accrued clinical studies 3,821 4,407 Contract liability — 697 Accrued interest, current 182 — Income taxes payable 14 55 Employee stock option pre-vesting exercise liability — 56 Accounts payable and other accrued liabilities $ 10,181 $ 8,680 (f) Other Long-Term Liabilities “Other long-term liabilities” consists of the following: September 30, 2022 December 31, 2021 Operating lease liability, non-current $ 169 $ 585 Lotilaner licensor liability 40 114 Other long-term liabilities $ 209 $ 699 |
Stockholders' Equity and Equity
Stockholders' Equity and Equity Incentive Plans | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stockholders' Equity and Equity Incentive Plans | STOCKHOLDERS’ EQUITY AND EQUITY INCENTIVE PLANS Common Stock Outstanding and Reserves for Future Issuance As of September 30, 2022, the Company had 26.7 million common shares issued and outstanding. As of December 31, 2021, the Company had both issued and outstanding shares of 20.7 million. Each share of common stock is entitled to one vote. The Company's outstanding equity awards and shares reserved for future issuance under its 2020 and 2016 Equity Incentive Plans and 2020 Employee Stock Purchase Plan is summarized below: September 30, 2022 December 31, 2021 Common stock awards reserved for future issuance under 2020 and 2016 Equity Incentive Plans 8,482,877 9,266,200 Common stock awards reserved for future issuance under the 2020 Employee Stock Purchase Plan 2,682,601 2,493,488 Stock options issued and outstanding (unvested and vested) under 2020 and 2016 Equity Incentive Plans 3,839,077 2,759,830 Restricted stock units issued and outstanding (unvested) under 2020 Equity Incentive Plan 516,005 17,251 Total shares of common stock reserved 15,520,560 14,536,769 Follow-On Public Offering In May 2022, the Company completed a follow-on public offering under its Shelf Registration Statement for an initial underwritten sale of 5.6 million shares of its common stock at a price of $13.50 per share. The Company also granted the underwriters a 30-day option to purchase up to 840,000 additional shares of its common stock at the public offering price. In June 2022, the underwriters partially exercised this option and the Company's sale of additional 289,832 shares at $13.50 per share was concurrently completed. Total gross proceeds from this offering were $79.5 million (before underwriting discounts, commissions and other estimated offering expenses), resulting in net proceeds of $74.3 million. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION Stock-Based Compensation Summary Stock-based compensation expense for the three and nine months ended September 30, 2022 and 2021 was reported in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 1,015 $ 544 $ 2,677 $ 1,315 General and administrative 2,568 1,575 7,112 4,961 Total stock-based compensation $ 3,583 $ 2,119 $ 9,789 $ 6,276 |
Net (Loss) Income Per Share
Net (Loss) Income Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net (Loss) Income Per Share | NET (LOSS) INCOME PER SHARE The following table sets forth the computation of basic and diluted net (loss) income per share: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Basic EPS Net (loss) income $ (22,511) $ (15,697) $ (48,492) $ 1,024 Less: undistributed income allocated to participating securities — — — 7 Net (loss) income available to common shareholders $ (22,511) $ (15,697) $ (48,492) $ 1,017 Basic weighted average shares outstanding 26,662,374 20,641,285 23,923,512 20,511,973 Net (loss) income per share—basic $ (0.84) $ (0.76) $ (2.03) $ 0.05 Diluted EPS Net (loss) income $ (22,511) $ (15,697) $ (48,492) $ 1,024 Less: undistributed income reallocated to participating securities — — — 7 Net (loss) income available to common shareholders $ (22,511) $ (15,697) $ (48,492) $ 1,017 Basic weighted average shares outstanding 26,662,374 20,641,285 23,923,512 20,511,973 Effect of dilutive securities: Common stock options — — — 1,520,514 Diluted weighted average shares outstanding 26,662,374 20,641,285 23,923,512 22,032,487 Net (loss) income per share—diluted $ (0.84) $ (0.76) $ (2.03) $ 0.05 The following outstanding and potentially dilutive securities were excluded from the calculation of diluted net loss per share because their impact under the “treasury stock method” and “if-converted method” would have been anti-dilutive for each period presented: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Stock options, unexercised—vested and unvested 3,839,077 2,663,356 3,839,077 902,981 Stock options exercised prior to vesting— remaining unvested — 43,149 — 43,149 Restricted stock units—unvested 516,005 4,257 516,005 4,257 Total 4,355,082 2,710,762 4,355,082 950,387 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS The table below summarizes certain financial instruments measured at fair value that are included within the accompanying balance sheets, and their designation among the three fair value measurement categories (see Note 2(ix) ): September 30, 2022 Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Money market funds $ 159,552 $ — $ — $ 159,552 U.S. Treasury securities 34,482 — — 34,482 Commercial paper — 27,377 — 27,377 Corporate debt securities — 5,161 — 5,161 Common stock (LianBio shares included in "long-term investments") 157 — — 157 Equity warrants (for LianBio shares included in "other assets") — — 246 246 Total assets measured at fair value $ 194,191 $ 32,538 $ 246 $ 226,975 December 31, 2021 Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Money market funds $ 171,332 $ — $ — $ 171,332 Common stock (LianBio shares included in "marketable securities") 483 — — 483 Equity warrants (for LianBio shares included in "other assets") — — 663 663 Total assets measured at fair value $ 171,815 $ — $ 663 $ 172,478 Money Market Funds and U.S. Treasury Securities Money market funds and U.S. Treasury securities have readily-available market prices in active markets that are publicly observable at the measurement date. Commercial Paper and Corporate Debt Securities Commercial paper and corporate debt securities were valued using third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. LianBio Common Stock and Equity Warrants In March 2021, contemporaneous with the China Out-License transaction (see Note 9 ), the Company and LianBio (a pharmaceutical company focused on the Greater China and other Asian markets; NASDAQ: LIAN), executed a warrant agreement for the Company to purchase, in three tranches, a stated number of common shares in LianBio. The first two tranches are vested as of September 30, 2022 and the third warrant tranche will vest upon the achievement of a certain regulatory event; each has an exercise price at common stock par value. In June 2021, one of these three warrant tranches was vested and then-converted to 78,373 shares of LianBio common stock, reported within "marketable securities" as of December 31, 2021, and within "long-term investments" as of September 30, 2022. LianBio common stock is classified within Level 1 of the fair value hierarchy, given its publicly reported price on the NASDAQ Global Market. In May 2022, the second warrant tranche vested, but has not yet been exercised. The second and third warrant tranche remain classified as Level 3 in the fair value hierarchy as of September 30, 2022 and December 31, 2021 and are presented within "other assets" in the accompanying Condensed Balance Sheets (see Note 3(d) ). The most significant assumptions used in the option pricing valuation model as of each balance sheet date to determine its fair value included: LianBio common stock volatility (based on the historical volatility of similar companies), the probability of regulatory milestone achievement for vesting, and the application of an assumed discount rate. The estimated fair value of these equity warrants will be remeasured each reporting period with adjustments reported within "other income (expense), net" on the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income, until exercised or expired, and is presented in these accompanying financial statements as follows: Value of equity warrants (see Note 3(d) ) Fair value as of December 31, 2021 $ 663 Revaluation of equity warrant value in "other income (expense), net" within the Condensed Statement of Operations (245) Fair value as of March 31, 2022 $ 418 Recognition of equity warrant value in "total revenues" within the Condensed Statement of Operations 103 Revaluation of equity warrant value in "other income (expense), net" within the Condensed Statement of Operations (257) Fair value as of June 30, 2022 $ 264 Revaluation of equity warrant value in "other income (expense), net" within the Condensed Statement of Operations for the three months ended September 30, 2022 (18) Fair value as of September 30, 2022 $ 246 Value of equity warrants (see Note 3(d) ) Fair value as of December 31, 2020 $ — Initial fair value estimate of equity warrant value in "total revenues" 1,233 Fair value as of March 31, 2021 $ 1,233 Recognition of equity warrant value in "total revenues" within the Condensed Statement of Operations 719 Revaluation of equity warrant value in "other income (expense), net" within the Condensed Statement of Operations (876) Fair value as of June 30, 2021 $ 1,076 Recognition of equity warrant value in "total revenues" within the Condensed Statement of Operations for the three months ended September 30, 2021 771 Revaluation of equity warrant value in "other income (expense), net" within the Condensed Statement of Operations for the three months ended September 30, 2021 (346) Fair value as of September 30, 2021 $ 1,501 The following table summarizes the estimated value of the Company’s cash, cash equivalents, marketable securities, and equity securities, including the gross unrealized holding gains and losses: September 30, 2022 Amortized cost Unrealized gains Unrealized losses Estimated fair value Cash and cash equivalents: Money market funds $ 159,552 $ — $ — $ 159,552 U.S. Treasury securities 3,978 1 — 3,979 Commercial paper 5,958 — — 5,958 Total cash and cash equivalents $ 169,488 $ 1 $ — $ 169,489 Marketable securities: U.S. Treasury securities $ 30,511 $ 7 $ (15) $ 30,503 Commercial paper 21,419 — — 21,419 Corporate debt securities 5,164 — (3) 5,161 Total marketable securities $ 57,094 $ 7 $ (18) $ 57,083 Long-term investments: Common stock in LianBio $ 483 $ — $ (326) $ 157 Total long-term investments $ 483 $ — $ (326) $ 157 December 31, 2021 Amortized cost Unrealized gains Unrealized losses Estimated fair value Cash and cash equivalents: Money market funds $ 171,332 $ — $ — $ 171,332 Total cash and cash equivalents $ 171,332 $ — $ — $ 171,332 Marketable securities: Common stock in LianBio $ 1,074 $ — $ (591) $ 483 Total marketable securities $ 1,074 $ — $ (591) $ 483 As of September 30, 2022, all available-for-sale debt securities have a maturity of 12 months or less with gross unrealized losses in a continuous loss position for less than one year. |
Commitment & Contingencies
Commitment & Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitment & Contingencies | (a) Facility Leases Overview In the ordinary course of business, the Company enters into lease agreements with unaffiliated third parties for its facilities and office equipment. As of September 30, 2022 and December 31, 2021, the Company had four active leases in Irvine, California for adjacent office and laboratory suites that each expire on January 31, 2024. The Company's operating leases have fixed annual rent amounts, payable monthly (operating lease costs), and our facility leases require payments for real estate taxes, insurance costs, and common area maintenance (variable lease costs). The variable lease costs are expensed as incurred and excluded from the reported lease asset and liability amounts presented in the accompanying Condensed Balance Sheets, as summarized in the below table. During the year ended December 31, 2021, and the nine months ended September 30, 2022, the Company had no sublease arrangements with it as lessor. Financial Reporting Captions The below table summarizes the lease asset and liability accounts presented on the accompanying Condensed Balance Sheets: Operating Leases Condensed Balance Sheet Caption September 30, 2022 December 31, 2021 Operating lease right-of-use assets— non-current Operating lease right-of-use assets $ 696 $ 1,074 Operating lease liability— current Accounts payable and other accrued liabilities $ 572 $ 609 Operating lease liability— non-current Other long-term liabilities 169 585 Total lease liabilities $ 741 $ 1,194 Components of Lease Expense The liability associated with each lease is amortized over the respective lease term using the “effective interest rate method.” The Company’s "operating lease right-of-use assets" are amortized over each lease term on a straight-line basis and is allocated to "research and development" and "general and administrative" expenses in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income. The below table summarizes the components of total lease expense: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Operating lease cost $ 142 $ 118 $ 427 $ 238 Variable lease cost 67 33 168 104 Short-term lease cost (lease with 12 month term or less) — 21 — 116 Total lease expense $ 209 $ 172 $ 595 $ 458 Weighted-Average Remaining Lease Term and Applied Discount Rate As of September 30, 2022, the Company's facility leases had a weighted average remaining lease term of 1 year, 4 months. The weighted-average estimated incremental borrowing rate of 10% was utilized to present value future minimum lease payments since an implicit interest rate in each at-market lease agreement was not determinable. Future Contractual Lease Payments The below table summarizes the (i) minimum lease payments over the next five years and thereafter, (ii) lease arrangement imputed interest, and (iii) present value of future lease payments: Operating Leases - Future Payments September 30, 2022 2022 (remaining three months, net of landlord credits) $ — 2023 736 2024 66 2025 — 2026 — Total future lease payments, undiscounted $ 802 (Less): Imputed interest (61) Present value of operating lease payments $ 741 (b) In-License Agreements for Lotilaner January 2019 Agreement for Skin and Eye Disease or Conditions in Humans In January 2019, the Company entered into a license agreement with Elanco Tiergesundheit AG (“Elanco”) for exclusive worldwide rights to certain intellectual property for the development and commercialization of lotilaner in the treatment or cure of any eye or skin disease or condition in humans, as amended in June 2022 (the "Eye and Derm Elanco Agreement"). The Company has sole financial responsibility for related development, regulatory, and commercialization activities. The Company made a $1.0 million upfront payment at execution of the Eye and Derm Elanco Agreement in January 2019, and also made a required $1.0 million clinical milestone payment in September 2020, associated with the first two U.S. pivotal trials for the treatment of Demodex blepharitis. The Company paid an additional $2.0 million for its second pivotal trial milestone in April 2021, which was recorded in “research and development” expense in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income for the three months ended June 30, 2021. As part of the China Out-License discussed in Note 9 , the Company made a contractual payment in the amount of $2.5 million to Elanco following the receipt of $25 million of initial proceeds from LianBio during the second quarter of 2021. In June 2022, the Company made a contractual prepayment of $1.5 million that can be applied towards any milestones that become due under the Eye and Derm Elanco Agreement and/or the Company’s in-license agreement with Elanco, granting it a worldwide license to certain intellectual property for the development and commercialization of lotilaner for the treatment, palliation, prevention, or cure of “all other” diseases and conditions in humans (i.e., beyond that of the eye or skin), as amended in June 2022 (the “All Human Uses Elanco Agreement”). This prepayment is included within "prepaid expenses" on the accompanying Condensed Balance Sheet as of September 30, 2022. The Company may make further cash payments to Elanco under the Eye and Derm Elanco Agreement upon achievement of certain clinical milestones in the treatment of human skin diseases using lotilaner for an aggregate maximum of $3.0 million and various commercial and sales threshold milestones for an aggregate maximum of $79.0 million. In addition, the Company will be obligated to pay tiered contractual royalties to Elanco in the mid to high single digits of its net sales. If the Company receives certain types of payments from its sublicensees, it will be obligated to pay Elanco a variable percentage in the low to mid double-digits of such proceeds, except for territories in which it achieved applicable regulatory approval prior to sublicense execution. September 2020 Agreement for All Other Diseases or Conditions in Humans In September 2020, the Company executed the All Human Uses Elanco Agreement with Elanco. In September 2020, the Company issued Elanco 222,460 shares of its common stock at the execution of the All Human Uses Elanco Agreement with an estimated fair value of $3.1 million ($14.0003 per share, approximating the issuance price of the Company's Series C preferred stock in September 2020). The Company is required to make cash payments to Elanco under the All Human Uses Elanco Agreement upon the achievement of various clinical milestones for an aggregate maximum of $4.5 million and various commercial and sales threshold milestones for an aggregate maximum of $77.0 million. In addition, the Company will be obligated to pay contractual royalties to Elanco in the single digits of its net product sales. If the Company receives certain types of payments from its sublicensees, it will also be obligated to pay Elanco a variable percentage in the low to mid double-digits of such proceeds, except for territories in which it achieved applicable regulatory approval prior to sublicense execution. In March 2021, the Company entered into the China Out-License with LianBio (see Note 9 ) that required it to grant Elanco an additional fixed 187,500 shares of its common stock that otherwise would have been issuable no later than the 18-month anniversary of the All Human Uses Elanco Agreement for its continued license exclusivity. These issued shares were valued at $5.5 million, based on the Company's stock closing price of $29.30 per share on the date this issuance became contractually required and is reported within "research and development" expense within the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income for the nine months ended September 30, 2021. (c) Employment Agreements The Company has entered into employment agreements with eight of its executive officers. These agreements provide for the payment of certain benefits upon separation of employment under specified circumstances, such as termination without cause, or termination in connection with a change in control event. (d) Litigation Contingencies From time to time, the Company may be subject to various litigation and related matters arising in the ordinary course of business. The Company is currently not aware of any such matters where there is at least a reasonable probability that a material loss, if any, has been or will be incurred for financial statement recognition. (e) Indemnities and Guarantees The Company has certain indemnity commitments, under which it may be required to make payments to its officers and directors in relation to certain transactions to the maximum extent permitted under applicable laws. The duration of these indemnities vary, and in certain cases, are indefinite and do not provide for any limitation of maximum payments. The Company has not been obligated to make any such payments to date and no liabilities have been recorded for this contingency in the accompanying Condensed Balance Sheets. |
Out-License Agreement
Out-License Agreement | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Out-License Agreement | OUT-LICENSE AGREEMENT Out-License of TP-03 Commercial Rights in the China Territory in March 2021 On March 26, 2021, the Company entered into The China Out-License with LianBio for its exclusive development and commercialization rights of TP-03 (lotilaner ophthalmic solution, 0.25%) in the China Territory for the treatment of Demodex blepharitis and Meibomian Gland Disease. LianBio is contractually responsible for all clinical development and commercialization activities and costs within the China Territory. Through September 30, 2022, the Company received payments from LianBio totaling $70.0 million, comprised of initial consideration of $25.0 million and $45.0 million for the achievement of three clinical development milestones. The Company is eligible to receive further consideration from LianBio upon the achievement of additional events, including: (i) TP-03 clinical development and regulatory milestones (China-based) of up to $30.0 million ($10 million of which was achieved in November 2022 - see Note 11 ), (ii) TP-03 drug supply agreement milestone of $5.0 million, (iii) TP-03 sales-based milestones for the China Territory of up to $100 million, (iv) tiered mid-to-high-teen royalties for China Territory TP-03 product sales, and (v) vesting of a LianBio equity warrant upon China regulatory milestone achievement. For the nine months ended September 30, 2022 and the three and nine months ended 2021, the Company reported "license fees" and "collaboration revenue" in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income, in accordance with the revenue recognition accounting policy described in Note 2(vii). |
Credit Facility Agreement
Credit Facility Agreement | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Credit Facility Agreement | CREDIT FACILITY AGREEMENT On February 2, 2022, the Company executed the Credit Facility with Hercules and SVB that expires on February 2, 2027. The Credit Facility provides an aggregate principal amount of up to $175.0 million with tranched availability as follows: $40.0 million at its execution (to-date, $20.0 million drawn February 2022), $25.0 million upon submission of the NDA with the FDA for TP-03 (available with NDA submission announced in September 2022), $35.0 million upon FDA approval of TP-03, $50.0 million upon achievement of product net revenue thresholds, and $25.0 million upon lender approval. Each of these tranches may be drawn down in $5.0 million increments at the Company's election. The Credit Facility requires interest-only payments through February 1, 2026, followed by 12 months of principal amortization, unless extended for one year to its maturity, upon meeting certain contractual conditions. All unpaid amounts under the Credit Facility become due on its February 2, 2027 expiry. Principal draws accrue interest on the outstanding principal balance at a floating interest rate per annum equal to the greater of either (i) The Wall Street Journal ("WSJ") prime rate plus 5.20% or (ii) 8.45%. At the execution date of the Credit Facility, the WSJ prime rate was 3.25% and further increased during 2022, reaching 6.25% as of September 30, 2022. The Company is required to pay a specified fee upon the earlier of (i) February 2, 2027 or (ii) the date the Company prepays, in full or in part, the outstanding principal balance of the Credit Facility ("End of Term Charge"). The current End of Term Charge of $1.0 million was derived at the execution of the Credit Facility by multiplying 4.75% by the $20.0 million drawn at closing and is accreted to "interest expense" through maturity. As of September 30, 2022, the carrying value of the Credit Facility (reported as "term loan, net" on the accompanying Condensed Balance Sheets) consisted of $20.0 million principal outstanding less legal and administrative issuance costs of approximately $0.9 million that were recorded as a "contra-liability" to "term loan, net" and will continue to be accreted to "interest expense" using the effective interest method during its term. As of December 31, 2021 the Company had no outstanding debt. The effective interest rate (i.e., coupon rate and other applicable fees) for the full term of the Credit Facility was 12.37%, as calculated September 30, 2022 with the latest coupon interest rate. During the three and nine months ended September 30, 2022, the Company recognized "interest expense" on its Condensed Statement of Operations and Comprehensive (Loss) Income in connection with the Credit Facility as follows: Three Months Ended Nine Months Ended Interest expense for term loan $ 539 $ 1,275 Accretion of end of term charge 48 127 Amortization of debt issuance costs 46 105 Total interest expense related to term loan $ 633 $ 1,507 The principal balance of this Credit Facility and related accretion and amortization as of September 30, 2022 is reported on a combined basis as "term loan, net" on the accompanying Condensed Balance Sheet as follows: September 30, 2022 Term loan, gross (amount drawn) $ 20,000 Debt issuance costs (legal and other administrative fees) (875) Accretion of end of term charge 127 Accumulated amortization of debt issuance costs 104 Term loan, net $ 19,356 |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Event | SUBSEQUENT EVENTS China Out-License Milestone Achievement On November 1, 2022, LianBio announced the dosing of their first patient in the Phase 3 LIBRA clinical trial of TP-03 in Chinese patients with Demodex blepharitis; the Company is entitled to receive a contractual milestone payment of $10 million from this licensee. TP-03 PDUFA Date: August 25, 2023 On November 9, 2022, the Company announced the acceptance of its NDA by the FDA for TP-03 for the treatment of Demodex blepharitis with a Prescription Drug User Fee Act (PDUFA) decision date of August 25, 2023. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Use of Estimates (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Operating Segment | To date, the Company has operated and managed its business and financial information on an aggregate basis based on its organizational structure, for the purposes of evaluating financial performance and the allocation of capital and personnel resources, consistent with the way operations and investments are centrally managed and evaluated. Accordingly, the Company’s management determined that it operates one reportable operating segment. This single segment is focused exclusively on developing pharmaceutical products for eventual commercialization. |
Basis of Presentation | Basis of Presentation The Company’s Condensed Financial Statements have been prepared in conformity with generally accepted accounting principles ("GAAP") in the United States ("U.S.") for interim financial information and pursuant to Form 10-Q and with the rules and regulations of the Securities and Exchange Commission ("SEC"). Accordingly, the accompanying Condensed Financial Statements do not include all of the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the audited financial statements and the related notes thereto in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 14, 2022. The interim Condensed Balance Sheet as of September 30, 2022, the interim Condensed Statements of Operations and Comprehensive (Loss) Income, and the interim Condensed Statements of Stockholders’ Equity for the three and nine months ended September 30, 2022 and 2021, and the interim Condensed Statements of Cash Flows for the nine months ended September 30, 2022 and 2021 are unaudited. These unaudited interim financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, which consist of only normal and recurring adjustments for the fair presentation of its financial information. The financial data and other information disclosed in these notes related to the three and nine-month periods are also unaudited. The Condensed Balance Sheet as of December 31, 2021 has been derived from the audited financial statements at that date but does not include all information and footnotes required by GAAP for annual financial statements. The condensed interim operating results for three and nine months ended September 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022 or any other interim or annual period. The preparation of financial statements in conformity with GAAP and with the rules and regulations of the SEC requires management to make informed estimates and assumptions that affect the amounts reported in these financial statements and accompanying notes. These estimates and assumptions involve judgments with respect to numerous factors that are difficult to forecast and may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. There have been no significant changes in the Company’s significant accounting policies during the three and nine months ended September 30, 2022, as compared with those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 14, 2022, except as discussed below. The accounting policies and estimates that most significantly impact the presented amounts within the accompanying Condensed Financial Statements are further described below. |
Cash and Cash Equivalents | Cash and Cash EquivalentsCash and cash equivalents consist of bank deposits and highly liquid investments, including money market fund accounts, that are readily convertible into cash without penalty, with original maturities of three months or less from the purchase date. |
Marketable Securities and Long-Term Investments | Marketable Securities and Long-Term Investments As of September 30, 2022, marketable securities consist of short term fixed income investments that have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities (see Note 7 ). Management determines the appropriate classification of its investments in fixed income securities at the time of purchase. Available-for-sale securities are classified as current assets on the accompanying Condensed Balance Sheets due to their highly liquid nature and availability for use in current operations. Marketable securities are recorded at fair value with unrealized losses and gains reported as a component of "accumulated other comprehensive loss" within the Condensed Statements of Stockholders' Equity until realized. The Company periodically evaluates whether declines in fair values of its available-for-sale securities below their book value are other-than-temporary. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. Management believes the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company’s results of operations involve numerous risks and uncertainties. Factors that could adversely impact the Company’s operating results and business objectives include, but are not limited to, (1) uncertainty of results of clinical trials, (2) uncertainty of regulatory approval of the Company’s potential product candidates, (3) uncertainty of market acceptance of its product candidates, (4) competition from substitute products and other companies, (5) securing and protecting proprietary technology and strategic relationships, and (6) dependence on key individuals and sole source suppliers. The Company’s product candidates require approvals from the U.S. Food and Drug Administration (“FDA”) and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed, or the Company is unable to maintain approval for any product candidate, it could have a materially adverse impact on its business. |
Revenue | Revenue Recognition for Out-License Arrangements Overview The Company currently has no product revenue. Reported revenue in the accompanying Statements of Operations and Comprehensive (Loss) Income is associated with one out-license agreement (the "China Out-License") that allows the third-party licensee to market the Company's TP-03 product candidate (representing "functional intellectual property") in the People's Republic of China, Hong Kong, Macau, and Taiwan (the "China territory") - see Note 9 . The accounting and reporting of revenue for out-license arrangements requires significant judgment for: (a) identification of the number of performance obligations within the contract, (b) the contract’s transaction price for allocation (including variable consideration), (c) the stand-alone selling price for each identified performance obligation, and (d) the timing and amount of revenue recognition in each period. The China Out-License was analyzed under GAAP to determine whether the promised goods or services are distinct, or in the alternative, must be accounted for as part of a combined performance obligation. In making these assessments, the Company considers factors such as the stage of development of the underlying intellectual property and the capabilities of the customer to develop the intellectual property on their own, and/or whether the required expertise is readily available. If the license is considered to not be distinct, the license is combined with other promised goods or services as a combined performance obligation for revenue recognition. The China Out-License includes the following forms of consideration: (i) non-refundable upfront license payments, (ii) equity securities and warrants, (iii) sales-based royalties, (iv) sales threshold milestones, (v) development milestone payments, and (vi) regulatory milestone payments. Revenue is recognized in proportion to the allocated transaction price when (or as) the respective performance obligation is satisfied. The Company evaluates the progress related to each milestone at each reporting period and, if necessary, also adjusts the probability of achievement and related revenue recognition. The measure of progress, and thereby periods over which revenue is recognized, is subject to estimates by management and may change over the course of the respective agreement. Contractual Terms for Receipt of Payments The contractual terms that establish the Company’s right to collect specified amounts from its customers and that require contemporaneous evaluation and documentation under GAAP for the corresponding timing and amount of revenue recognition, are as follows: (1) Upfront License Fees: The Company determines whether non-refundable license fee consideration is recognized at the time of contract execution (i.e., when the license is transferred to the customer and the customer is able to use and benefit from the license) or over the actual (or implied) contractual period of the China Out-License. The Company also evaluates whether it has any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer to determine whether any combined performance obligation is satisfied over time or at a point in time. Upfront payments may require deferral of revenue recognition to a future period until the Company performs obligations under these arrangements. (2) Development Milestones: The Company utilizes the “most likely amount” method to estimate the amount of consideration to which it will be entitled for achievement of development milestones as these represent variable consideration. For those payments based on development milestones (e.g., patient dosing in a clinical study or the achievement of statistically significant clinical results), the Company assesses the probability that the milestone will be achieved, including its ability to control the timing or likelihood of achievement, and any associated revenue constraint. Given the high degree of uncertainty around the occurrence of these events, the Company determines the milestone and other contingent amounts to be "constrained" until the uncertainty associated with these payments is resolved. At each reporting period, the Company re-evaluates this associated revenue recognition constraint. Any resulting adjustments are recorded to revenue on a cumulative catch-up basis, and reflected in the financial statements in the period of adjustment. (3) Regulatory Milestones: The Company utilizes the “most likely amount” method to estimate the consideration to which it will be entitled and recognizes revenue in the period regulatory approval occurs (the performance obligation is satisfied) as these represent variable consideration. Amounts constrained as variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company evaluates whether the milestones are considered probable of being reached and not otherwise "constrained." Accordingly, due to the inherent uncertainty of achieving regulatory approval, associated milestones are deemed constrained for revenue recognition until achievement. (4) Royalties: Under the "sales-or-usage-based royalty exception" the Company recognizes revenue based on the contractual percentage of the licensee’s sale of products to its customers at the later of (i) the occurrence of the related product sales or (ii) the date upon which the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue from its out-licensing arrangement. (5) Sales Threshold Milestones: Similar to royalties, applying the "sales-or-usage-based royalty exception", the Company recognizes revenue from sales threshold milestones at the later of (i) the period the licensee achieves the one-time annual product sales levels in their territories for which the Company is contractually entitled to a specified lump-sum receipt, or (ii) the date upon which the performance obligation to which some or all of the milestone has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any sales threshold milestone revenue from the out-licensing arrangement. The Company re-evaluates the measure of progress to each performance obligation in each reporting period as uncertain events are resolved and other changes in circumstances occur. A "performance obligation" is a promise in a contract |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred or as certain upfront or milestone payments become contractually due to licensors upon the achievement of clinical or regulatory events. These expenses also include internal costs directly attributable to in-development programs, including cost of certain salaries, payroll taxes, employee benefits, and stock-based compensation expense, as well as laboratory and clinical supplies, pre-clinical and clinical trial expenses, manufacturing costs for drug products before FDA approval, and the costs of various research and development contractors. Expenses for pre-clinical studies and clinical trial activities that are performed by third parties on behalf of the Company are typically based upon estimates of the proportion of work completed over the term of the individual study or trial, as well as patient enrollment and dosing events. These costs are in accordance with the agreements established with the contracted clinical research organizations and associated trial sites. The Company has entered, and may continue to enter into, license agreements to access and utilize intellectual property for drug development. In each case, the Company evaluates if the assets acquired in a transaction represent the acquisition of an "as set" or a "business" as defined under applicable GAAP. The Company’s executed in-license agreements (see Note 8 (b) ) were evaluated and determined to represent "asset" acquisitions. Because these assets have not yet received regulatory approval and have no alternative future use, the purchase price for each was immediately recognized as "research and development" expense in the accompanying financial statements. In addition, any future milestone payments (whether in the form of cash or stock) made before product regulatory approval (that do not meet the definition of a "derivative") will also be immediately recognized as "research and development" expense when it becomes payable, provided there is no alternative future use in other research and development projects for its capitalization. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes stock-based compensation expense for equity awards granted to employees, consultants, and members of its Board of Directors. The Black-Scholes pricing model is used to estimate the fair value of stock option awards as of the date of grant. The fair value of restricted stock units is representative of the closing share price preceding the date of grant. For stock-based awards that vest subject to the satisfaction of a service requirement, the related expense is recognized on a straight-line basis over each award’s actual or implied vesting period. For stock-based awards that vest subject to a performance condition, the Company recognizes related expense on an accelerated attribution method, if and when it concludes that it is highly probable that the performance condition will be achieved. As applicable, the Company reverses previously recognized expense for unvested awards in the same period of forfeiture. The measurement of the fair value of stock option awards and recognition of stock-based compensation expense requires assumptions to be estimated by management that involve inherent uncertainties and the application of management’s judgment, including (a) the fair value of the Company’s common stock on the date of the option grant, (b) the expected term of the stock option until its exercise by the recipient, (c) stock price volatility over the expected term, (d) the prevailing risk-free interest rate over the expected term, and (e) expected dividend payments over the expected term. Management estimates the expected term of awarded stock options utilizing the “simplified method” for awards since the Company does not yet have sufficient exercise history since its November 2016 corporate formation and also lacks specific historical and implied stock volatility information. Accordingly, management estimates this expected volatility based on a designated peer-group of publicly-traded companies for a look-back period (from the date of grant) that corresponds with the expected term of the awarded stock option. The Company estimates the risk-free interest rate based upon the U.S. Department of the Treasury yield curve in effect at award grant for time period that corresponds with the expected term of the awarded stock option. The Company’s expected dividend yield is zero because it has never paid cash dividends and does not expect to for the foreseeable future. The fair value of the Company’s common stock is based on the closing quoted market price of its common stock as reported by the Nasdaq Global Select Market on the date of grant. |
Net (Loss) Income per Share | Net (Loss) Income per Share Basic net (loss) income per share is calculated by dividing the net (loss) income by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive shares of common stock. Diluted net (loss) income per share is computed by dividing the net (loss) income by the weighted-average number of common stock equivalents outstanding for the period determined using the "treasury-stock method" and "if-converted method" as applicable. The Company’s "participating securities" include unvested common stock awards issued upon early exercise of certain stock options, as early exercised unvested common stock awards have a non-forfeitable right to dividends. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses, so in periods of net losses, the "two-class method" of calculating basic and diluted earnings per share is not required. In periods of net income, basic and diluted net loss per share attributable to common stockholders is presented in conformity with the two-class method required for participating securities. Also, net income is attributed to both common stockholders and participating security holders, and therefore, net income is allocated to shares of common stock and participating securities, as if all of the earnings for the period had been distributed. Diluted earnings per share under the two-class method is calculated using the more dilutive of the treasury stock or the two-class method. Due to a net loss for the three and nine months ended September 30, 2022, all otherwise potentially dilutive securities are antidilutive, and accordingly, the reported basic net loss per share equals the reported diluted net loss per share in this period. |
Fair Value Measurements | Fair Value Measurements Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: • Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. • Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. • 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 carrying amounts for financial instruments consisting of cash and cash equivalents, accounts payable and accrued liabilities approximate fair value due to the short maturities for each. The Company's equity warrant holdings are carried at fair value based on unobservable market inputs (see Note 7 ). Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. |
Comprehensive (Loss) Income | Comprehensive (Loss) Income Comprehensive (loss) income represents (i) net loss or income for the periods presented, and (ii) unrealized gains or losses on our reported available-for-sale debt securities. |
Recently Issued or Effective Accounting Standards | Recently Issued or Effective Accounting StandardsRecently issued or effective accounting pronouncements that impact, or may have an impact, on the Company’s financial statements have been discussed within the footnote to which each relates. Other recent accounting pronouncements not disclosed in these Condensed Financial Statements have been determined by the Company’s management to have no impact, or an immaterial impact, on its current and expected future financial position, results of operations, or cash flows. |
Balance Sheet Account Detail (T
Balance Sheet Account Detail (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Prepaid expenses and other current assets | September 30, 2022 December 31, 2021 Other prepaid expenses $ 3,430 $ 2,832 Prepaid insurance 64 1,213 Prepaid expenses $ 3,494 $ 4,045 |
Other receivables | “Other receivables” consists of the following: September 30, 2022 December 31, 2021 PDUFA Fee reimbursement (1) $ 3,117 $ — R&D payroll tax receivable 340 90 Clinical receivables 292 — Interest receivable 198 2 Income tax receivable 48 — Other receivables $ 3,995 $ 92 (1) This amount represents the required FDA filing fee upon the Company's submission of its New Drug Application ("NDA") for TP-03 in the third quarter of 2022. This fee is expected to be refunded in full, based on the Company's status as a qualified "Small Business" as defined in the relevant Federal statute. |
Property and equipment, net of accumulated depreciation | “Property and equipment, net” consists of the following: September 30, 2022 December 31, 2021 Furniture and fixtures $ 632 $ 596 Office equipment 197 84 Laboratory equipment 167 167 Leasehold improvements 403 129 Property and equipment, at cost 1,399 976 (Less): Accumulated depreciation and amortization 448 221 Property and equipment, net $ 951 $ 755 |
Other assets | "Other assets" consists of the following: September 30, 2022 December 31, 2021 Deposits $ 71 $ 71 Equity warrants issued by licensee ( Note 7 ) 246 663 Other non-current assets 266 392 Other assets $ 583 $ 1,126 |
Accounts payable and accrued liabilities | “Accounts payable and other accrued liabilities” consists of the following: September 30, 2022 December 31, 2021 Trade accounts payable and other $ 5,592 $ 2,856 Operating lease liability, current 572 609 Accrued clinical studies 3,821 4,407 Contract liability — 697 Accrued interest, current 182 — Income taxes payable 14 55 Employee stock option pre-vesting exercise liability — 56 Accounts payable and other accrued liabilities $ 10,181 $ 8,680 |
Other long-term liabilities | “Other long-term liabilities” consists of the following: September 30, 2022 December 31, 2021 Operating lease liability, non-current $ 169 $ 585 Lotilaner licensor liability 40 114 Other long-term liabilities $ 209 $ 699 |
Stockholders' Equity and Equi_2
Stockholders' Equity and Equity Incentive Plans (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stock details | The Company's outstanding equity awards and shares reserved for future issuance under its 2020 and 2016 Equity Incentive Plans and 2020 Employee Stock Purchase Plan is summarized below: September 30, 2022 December 31, 2021 Common stock awards reserved for future issuance under 2020 and 2016 Equity Incentive Plans 8,482,877 9,266,200 Common stock awards reserved for future issuance under the 2020 Employee Stock Purchase Plan 2,682,601 2,493,488 Stock options issued and outstanding (unvested and vested) under 2020 and 2016 Equity Incentive Plans 3,839,077 2,759,830 Restricted stock units issued and outstanding (unvested) under 2020 Equity Incentive Plan 516,005 17,251 Total shares of common stock reserved 15,520,560 14,536,769 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based compensation | Stock-based compensation expense for the three and nine months ended September 30, 2022 and 2021 was reported in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 1,015 $ 544 $ 2,677 $ 1,315 General and administrative 2,568 1,575 7,112 4,961 Total stock-based compensation $ 3,583 $ 2,119 $ 9,789 $ 6,276 |
Net (Loss) Income Per Share (Ta
Net (Loss) Income Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net (loss) income per share, basis and diluted | The following table sets forth the computation of basic and diluted net (loss) income per share: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Basic EPS Net (loss) income $ (22,511) $ (15,697) $ (48,492) $ 1,024 Less: undistributed income allocated to participating securities — — — 7 Net (loss) income available to common shareholders $ (22,511) $ (15,697) $ (48,492) $ 1,017 Basic weighted average shares outstanding 26,662,374 20,641,285 23,923,512 20,511,973 Net (loss) income per share—basic $ (0.84) $ (0.76) $ (2.03) $ 0.05 Diluted EPS Net (loss) income $ (22,511) $ (15,697) $ (48,492) $ 1,024 Less: undistributed income reallocated to participating securities — — — 7 Net (loss) income available to common shareholders $ (22,511) $ (15,697) $ (48,492) $ 1,017 Basic weighted average shares outstanding 26,662,374 20,641,285 23,923,512 20,511,973 Effect of dilutive securities: Common stock options — — — 1,520,514 Diluted weighted average shares outstanding 26,662,374 20,641,285 23,923,512 22,032,487 Net (loss) income per share—diluted $ (0.84) $ (0.76) $ (2.03) $ 0.05 |
Outstanding potentially dilutive securities | The following outstanding and potentially dilutive securities were excluded from the calculation of diluted net loss per share because their impact under the “treasury stock method” and “if-converted method” would have been anti-dilutive for each period presented: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Stock options, unexercised—vested and unvested 3,839,077 2,663,356 3,839,077 902,981 Stock options exercised prior to vesting— remaining unvested — 43,149 — 43,149 Restricted stock units—unvested 516,005 4,257 516,005 4,257 Total 4,355,082 2,710,762 4,355,082 950,387 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Financial instruments measured at fair value | The table below summarizes certain financial instruments measured at fair value that are included within the accompanying balance sheets, and their designation among the three fair value measurement categories (see Note 2(ix) ): September 30, 2022 Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Money market funds $ 159,552 $ — $ — $ 159,552 U.S. Treasury securities 34,482 — — 34,482 Commercial paper — 27,377 — 27,377 Corporate debt securities — 5,161 — 5,161 Common stock (LianBio shares included in "long-term investments") 157 — — 157 Equity warrants (for LianBio shares included in "other assets") — — 246 246 Total assets measured at fair value $ 194,191 $ 32,538 $ 246 $ 226,975 December 31, 2021 Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Money market funds $ 171,332 $ — $ — $ 171,332 Common stock (LianBio shares included in "marketable securities") 483 — — 483 Equity warrants (for LianBio shares included in "other assets") — — 663 663 Total assets measured at fair value $ 171,815 $ — $ 663 $ 172,478 |
Changes in fair value of equity warrants | The estimated fair value of these equity warrants will be remeasured each reporting period with adjustments reported within "other income (expense), net" on the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income, until exercised or expired, and is presented in these accompanying financial statements as follows: Value of equity warrants (see Note 3(d) ) Fair value as of December 31, 2021 $ 663 Revaluation of equity warrant value in "other income (expense), net" within the Condensed Statement of Operations (245) Fair value as of March 31, 2022 $ 418 Recognition of equity warrant value in "total revenues" within the Condensed Statement of Operations 103 Revaluation of equity warrant value in "other income (expense), net" within the Condensed Statement of Operations (257) Fair value as of June 30, 2022 $ 264 Revaluation of equity warrant value in "other income (expense), net" within the Condensed Statement of Operations for the three months ended September 30, 2022 (18) Fair value as of September 30, 2022 $ 246 Value of equity warrants (see Note 3(d) ) Fair value as of December 31, 2020 $ — Initial fair value estimate of equity warrant value in "total revenues" 1,233 Fair value as of March 31, 2021 $ 1,233 Recognition of equity warrant value in "total revenues" within the Condensed Statement of Operations 719 Revaluation of equity warrant value in "other income (expense), net" within the Condensed Statement of Operations (876) Fair value as of June 30, 2021 $ 1,076 Recognition of equity warrant value in "total revenues" within the Condensed Statement of Operations for the three months ended September 30, 2021 771 Revaluation of equity warrant value in "other income (expense), net" within the Condensed Statement of Operations for the three months ended September 30, 2021 (346) Fair value as of September 30, 2021 $ 1,501 |
Summary of estimated value of cash, cash equivalents, marketable securities, and equity securities | The following table summarizes the estimated value of the Company’s cash, cash equivalents, marketable securities, and equity securities, including the gross unrealized holding gains and losses: September 30, 2022 Amortized cost Unrealized gains Unrealized losses Estimated fair value Cash and cash equivalents: Money market funds $ 159,552 $ — $ — $ 159,552 U.S. Treasury securities 3,978 1 — 3,979 Commercial paper 5,958 — — 5,958 Total cash and cash equivalents $ 169,488 $ 1 $ — $ 169,489 Marketable securities: U.S. Treasury securities $ 30,511 $ 7 $ (15) $ 30,503 Commercial paper 21,419 — — 21,419 Corporate debt securities 5,164 — (3) 5,161 Total marketable securities $ 57,094 $ 7 $ (18) $ 57,083 Long-term investments: Common stock in LianBio $ 483 $ — $ (326) $ 157 Total long-term investments $ 483 $ — $ (326) $ 157 December 31, 2021 Amortized cost Unrealized gains Unrealized losses Estimated fair value Cash and cash equivalents: Money market funds $ 171,332 $ — $ — $ 171,332 Total cash and cash equivalents $ 171,332 $ — $ — $ 171,332 Marketable securities: Common stock in LianBio $ 1,074 $ — $ (591) $ 483 Total marketable securities $ 1,074 $ — $ (591) $ 483 |
Commitment & Contingencies (Tab
Commitment & Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Lease asset and liability accounts | The below table summarizes the lease asset and liability accounts presented on the accompanying Condensed Balance Sheets: Operating Leases Condensed Balance Sheet Caption September 30, 2022 December 31, 2021 Operating lease right-of-use assets— non-current Operating lease right-of-use assets $ 696 $ 1,074 Operating lease liability— current Accounts payable and other accrued liabilities $ 572 $ 609 Operating lease liability— non-current Other long-term liabilities 169 585 Total lease liabilities $ 741 $ 1,194 |
Components of lease cost | The below table summarizes the components of total lease expense: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Operating lease cost $ 142 $ 118 $ 427 $ 238 Variable lease cost 67 33 168 104 Short-term lease cost (lease with 12 month term or less) — 21 — 116 Total lease expense $ 209 $ 172 $ 595 $ 458 |
Future contractual lease payments | The below table summarizes the (i) minimum lease payments over the next five years and thereafter, (ii) lease arrangement imputed interest, and (iii) present value of future lease payments: Operating Leases - Future Payments September 30, 2022 2022 (remaining three months, net of landlord credits) $ — 2023 736 2024 66 2025 — 2026 — Total future lease payments, undiscounted $ 802 (Less): Imputed interest (61) Present value of operating lease payments $ 741 |
Credit Facility Agreement (Tabl
Credit Facility Agreement (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Interest Expense | During the three and nine months ended September 30, 2022, the Company recognized "interest expense" on its Condensed Statement of Operations and Comprehensive (Loss) Income in connection with the Credit Facility as follows: Three Months Ended Nine Months Ended Interest expense for term loan $ 539 $ 1,275 Accretion of end of term charge 48 127 Amortization of debt issuance costs 46 105 Total interest expense related to term loan $ 633 $ 1,507 |
Balances of Debt, Debt Issuance Costs, and Accumulated Accretion | The principal balance of this Credit Facility and related accretion and amortization as of September 30, 2022 is reported on a combined basis as "term loan, net" on the accompanying Condensed Balance Sheet as follows: September 30, 2022 Term loan, gross (amount drawn) $ 20,000 Debt issuance costs (legal and other administrative fees) (875) Accretion of end of term charge 127 Accumulated amortization of debt issuance costs 104 Term loan, net $ 19,356 |
Description of Business and P_2
Description of Business and Presentation of Financial Statements (Details) | 9 Months Ended |
Sep. 30, 2022 segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of reportable segments | 1 |
Number of operating segments | 1 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Use of Estimates (Details) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Expected dividend yield | 0% |
Balance Sheet Account Detail -
Balance Sheet Account Detail - Prepaid Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Other prepaid expenses | $ 3,430 | $ 2,832 |
Prepaid insurance | 64 | 1,213 |
Prepaid expenses | $ 3,494 | $ 4,045 |
Balance Sheet Account Detail _2
Balance Sheet Account Detail - Other Receivables (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
PDUFA Fee reimbursement | $ 3,117 | $ 0 |
R&D payroll tax receivable | 340 | 90 |
Clinical receivables | 292 | 0 |
Interest receivable | 198 | 2 |
Income tax receivable | 48 | 0 |
Other receivables | $ 3,995 | $ 92 |
Balance Sheet Account Detail _3
Balance Sheet Account Detail - Property and Equipment, Net of Accumulated Depreciation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, at cost | $ 1,399 | $ 1,399 | $ 976 | ||
(Less): Accumulated depreciation and amortization | 448 | 448 | 221 | ||
Property and equipment, net | 951 | 951 | 755 | ||
Depreciation | 100 | $ 100 | 200 | $ 300 | |
Furniture and fixtures | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, at cost | 632 | 632 | 596 | ||
Office equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, at cost | 197 | 197 | 84 | ||
Laboratory equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, at cost | 167 | 167 | 167 | ||
Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, at cost | $ 403 | $ 403 | $ 129 |
Balance Sheet Account Detail _4
Balance Sheet Account Detail - Other Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Deposits | $ 71 | $ 71 |
Equity warrant rights | 246 | 663 |
Other non-current assets | 266 | 392 |
Other assets | $ 583 | $ 1,126 |
Balance Sheet Account Detail _5
Balance Sheet Account Detail - Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Trade accounts payable and other | $ 5,592 | $ 2,856 |
Operating lease liability, current | 572 | 609 |
Accrued clinical studies | 3,821 | 4,407 |
Contract liability | 0 | 697 |
Accrued interest, current | 182 | 0 |
Income taxes payable | 14 | 55 |
Employee stock option pre-vesting exercise liability | 0 | 56 |
Accounts payable and other accrued liabilities | $ 10,181 | $ 8,680 |
Balance Sheet Account Detail _6
Balance Sheet Account Detail - Other Long-Term Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Operating lease liability, non-current | $ 169 | $ 585 |
Lotilaner licensor liability | 40 | 114 |
Other long-term liabilities | $ 209 | $ 699 |
Stockholders' Equity and Equi_3
Stockholders' Equity and Equity Incentive Plans - Additional Information (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |||
Jun. 30, 2022 $ / shares shares | May 31, 2022 $ / shares shares | Jun. 30, 2022 USD ($) $ / shares | Sep. 30, 2022 vote shares | Dec. 31, 2021 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock, outstanding (shares) | 26,671,812 | 20,698,737 | |||
Common stock, issued (shares) | 26,671,812 | 20,726,580 | |||
Common stock votes | vote | 1 | ||||
Total shares of common stock reserved (in shares) | 15,520,560 | 14,536,769 | |||
Common stock awards reserved for future issuance under the 2020 Employee Stock Purchase Plan | 2,682,601 | 2,493,488 | |||
Follow-On Public Offering | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock issued (shares) | 5,600,000 | ||||
Original issue price (usd per share) | $ / shares | $ 13.50 | ||||
Stock issued, gross proceeds | $ | $ 79.5 | ||||
Stock issued, net proceeds | $ | $ 74.3 | ||||
Underwriters' option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock issued (shares) | 289,832 | 840,000 | |||
Original issue price (usd per share) | $ / shares | $ 13.50 | $ 13.50 |
Stockholders' Equity and Equi_4
Stockholders' Equity and Equity Incentive Plans - Shares Reserved for Issuance (Details) - shares | Sep. 30, 2022 | Dec. 31, 2021 |
Equity [Abstract] | ||
Stock options reserved for future grant (shares) | 8,482,877 | 9,266,200 |
Common stock awards reserved for future issuance under the 2020 Employee Stock Purchase Plan | 2,682,601 | 2,493,488 |
Stock options issued and outstanding (shares) | 3,839,077 | 2,759,830 |
Restricted stock units issued and outstanding (unvested) under 2020 Equity Incentive Plan | 516,005 | 17,251 |
Total shares of common stock reserved (shares) | 15,520,560 | 14,536,769 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | $ 3,583 | $ 2,119 | $ 9,789 | $ 6,276 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | 1,015 | 544 | 2,677 | 1,315 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | $ 2,568 | $ 1,575 | $ 7,112 | $ 4,961 |
Net (Loss) Income Per Share (De
Net (Loss) Income Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Basic EPS | ||||||||
Net (loss) income | $ (22,511) | $ (5,743) | $ (20,238) | $ (15,697) | $ 6,345 | $ 10,376 | $ (48,492) | $ 1,024 |
Less: undistributed income allocated to participating securities | 0 | 0 | 0 | 7 | ||||
Net (loss) income available to common shareholders | $ (22,511) | $ (15,697) | $ (48,492) | $ 1,017 | ||||
Basic weighted average shares outstanding (shares) | 26,662,374 | 20,641,285 | 23,923,512 | 20,511,973 | ||||
Net (loss) per share, basic (usd per share) | $ (0.84) | $ (0.76) | $ (2.03) | $ 0.05 | ||||
Diluted EPS | ||||||||
Net (loss) income | $ (22,511) | $ (5,743) | $ (20,238) | $ (15,697) | $ 6,345 | $ 10,376 | $ (48,492) | $ 1,024 |
Less: undistributed income reallocated to participating securities | 0 | 0 | 0 | 7 | ||||
Net (loss) income available to common shareholders | $ (22,511) | $ (15,697) | $ (48,492) | $ 1,017 | ||||
Basic weighted average shares outstanding (shares) | 26,662,374 | 20,641,285 | 23,923,512 | 20,511,973 | ||||
Effect of dilutive securities: | ||||||||
Common stock options (shares) | 0 | 0 | 0 | 1,520,514 | ||||
Diluted weighted average shares outstanding (shares) | 26,662,374 | 20,641,285 | 23,923,512 | 22,032,487 | ||||
Net (loss) income per share, diluted (usd per share) | $ (0.84) | $ (0.76) | $ (2.03) | $ 0.05 |
Net (Loss) Income Per Share - A
Net (Loss) Income Per Share - Antidilutive Securities (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of net income (loss) per share | 4,355,082 | 2,710,762 | 4,355,082,000 | 950,387,000 |
Stock options, unexercised—vested and unvested | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of net income (loss) per share | 3,839,077 | 2,663,356 | 3,839,077,000 | 902,981,000 |
Stock options exercised prior to vesting— remaining unvested | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of net income (loss) per share | 0 | 43,149 | 0 | 43,149,000 |
Restricted stock units—unvested | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of net income (loss) per share | 516,005 | 4,257 | 516,005,000 | 4,257,000 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Instruments Measured at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Assets: | ||
Fair value of cash and cash equivalents | $ 169,489 | $ 171,332 |
Corporate debt securities | 57,083 | |
Common stock (LianBio shares included in "long-term investments") | 157 | 483 |
Equity warrants (for LianBio shares included in "other assets") | 246 | 663 |
Total assets measured at fair value | 226,975 | 172,478 |
Money market funds | ||
Assets: | ||
Fair value of cash and cash equivalents | 159,552 | 171,332 |
U.S. Treasury securities | ||
Assets: | ||
Fair value of cash and cash equivalents | 3,979 | |
Debt securities, available for sale and cash and cash equivalents | 34,482 | |
Corporate debt securities | 30,503 | |
Commercial paper | ||
Assets: | ||
Fair value of cash and cash equivalents | 5,958 | |
Debt securities, available for sale and cash and cash equivalents | 27,377 | |
Corporate debt securities | 21,419 | |
Corporate debt securities | ||
Assets: | ||
Corporate debt securities | 5,161 | |
Level 1 | ||
Assets: | ||
Common stock (LianBio shares included in "long-term investments") | 157 | 483 |
Equity warrants (for LianBio shares included in "other assets") | 0 | 0 |
Total assets measured at fair value | 194,191 | 171,815 |
Level 1 | Money market funds | ||
Assets: | ||
Fair value of cash and cash equivalents | 159,552 | 171,332 |
Level 1 | U.S. Treasury securities | ||
Assets: | ||
Debt securities, available for sale and cash and cash equivalents | 34,482 | |
Level 1 | Commercial paper | ||
Assets: | ||
Debt securities, available for sale and cash and cash equivalents | 0 | |
Level 1 | Corporate debt securities | ||
Assets: | ||
Corporate debt securities | 0 | |
Level 2 | ||
Assets: | ||
Common stock (LianBio shares included in "long-term investments") | 0 | 0 |
Equity warrants (for LianBio shares included in "other assets") | 0 | 0 |
Total assets measured at fair value | 32,538 | 0 |
Level 2 | Money market funds | ||
Assets: | ||
Fair value of cash and cash equivalents | 0 | 0 |
Level 2 | U.S. Treasury securities | ||
Assets: | ||
Debt securities, available for sale and cash and cash equivalents | 0 | |
Level 2 | Commercial paper | ||
Assets: | ||
Debt securities, available for sale and cash and cash equivalents | 27,377 | |
Level 2 | Corporate debt securities | ||
Assets: | ||
Corporate debt securities | 5,161 | |
Level 3 | ||
Assets: | ||
Common stock (LianBio shares included in "long-term investments") | 0 | 0 |
Equity warrants (for LianBio shares included in "other assets") | 246 | 663 |
Total assets measured at fair value | 246 | 663 |
Level 3 | Money market funds | ||
Assets: | ||
Fair value of cash and cash equivalents | 0 | $ 0 |
Level 3 | U.S. Treasury securities | ||
Assets: | ||
Debt securities, available for sale and cash and cash equivalents | 0 | |
Level 3 | Commercial paper | ||
Assets: | ||
Debt securities, available for sale and cash and cash equivalents | 0 | |
Level 3 | Corporate debt securities | ||
Assets: | ||
Corporate debt securities | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 1 Months Ended | |
Mar. 31, 2021 tranche | Jun. 30, 2021 warrant shares | |
Fair Value Disclosures [Abstract] | ||
Number of tranches | tranche | 3 | |
Number of vested warrants | 1 | |
Number of warrants | 3 | |
Equity securities (in shares) | shares | 78,373 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Fair Value of Equity Warrants (Details) - USD ($) $ in Thousands | 3 Months Ended | |||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||||
Fair value, beginning of period | $ 264 | $ 418 | $ 663 | $ 1,076 | $ 1,233 | $ 0 |
Revaluation of equity warrants | (18) | (245) | 1,233 | |||
Fair value, end of period | $ 246 | 264 | $ 418 | 1,501 | 1,076 | $ 1,233 |
Other income (expense), net | ||||||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||||
Revaluation of equity warrants | (257) | (346) | (876) | |||
Total revenues | ||||||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||||
Revaluation of equity warrants | $ 103 | $ 771 | $ 719 |
Fair Value Measurements - Estim
Fair Value Measurements - Estimated Value of Cash, Cash Equivalents, Marketable Securities, and Equity Securities (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Cash and cash equivalents: | ||
Amortized cost | $ 169,488 | $ 171,332 |
Unrealized gains | 1 | |
Fair value of cash and cash equivalents | 169,489 | 171,332 |
Marketable securities: | ||
Amortized cost | 57,094 | |
Unrealized gains | 7 | |
Unrealized losses | (18) | |
Debt Securities, Available-for-Sale | 57,083 | |
Long-term investments: | ||
Amortized cost | 483 | 1,074 |
Unrealized gains | 0 | 0 |
Unrealized losses | (326) | (591) |
Estimated fair value | 157 | 483 |
Money market funds | ||
Cash and cash equivalents: | ||
Amortized cost | 159,552 | 171,332 |
Fair value of cash and cash equivalents | 159,552 | $ 171,332 |
U.S. Treasury securities | ||
Cash and cash equivalents: | ||
Amortized cost | 3,978 | |
Unrealized gains | 1 | |
Fair value of cash and cash equivalents | 3,979 | |
Marketable securities: | ||
Amortized cost | 30,511 | |
Unrealized gains | 7 | |
Unrealized losses | (15) | |
Debt Securities, Available-for-Sale | 30,503 | |
Commercial paper | ||
Cash and cash equivalents: | ||
Amortized cost | 5,958 | |
Fair value of cash and cash equivalents | 5,958 | |
Marketable securities: | ||
Amortized cost | 21,419 | |
Unrealized gains | 0 | |
Unrealized losses | 0 | |
Debt Securities, Available-for-Sale | 21,419 | |
Corporate debt securities | ||
Marketable securities: | ||
Amortized cost | 5,164 | |
Unrealized gains | 0 | |
Unrealized losses | (3) | |
Debt Securities, Available-for-Sale | $ 5,161 |
Commitment & Contingencies - Fa
Commitment & Contingencies - Facility Leases (Details) $ in Thousands | Sep. 30, 2022 USD ($) contract | Dec. 31, 2021 USD ($) contract |
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | $ | $ 696 | $ 1,074 |
Weighted average remaining lease term | 1 year 4 months | |
Estimated incremental borrowing rate | 10% | |
Irvine office and laboratory facility | ||
Lessee, Lease, Description [Line Items] | ||
Number of leases | contract | 4 | 4 |
Commitment & Contingencies - Le
Commitment & Contingencies - Lease Asset and Liability Accounts (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use assets | $ 696 | $ 1,074 |
Operating lease liability, current | $ 572 | $ 609 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accounts payable and other accrued liabilities | Accounts payable and other accrued liabilities |
Operating lease liability, non-current | $ 169 | $ 585 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other long-term liabilities | Other long-term liabilities |
Present value of operating lease payments | $ 741 | $ 1,194 |
Commitment & Contingencies - _2
Commitment & Contingencies - Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease cost | $ 142 | $ 118 | $ 427 | $ 238 |
Variable lease cost | 67 | 33 | 168 | 104 |
Short-term lease cost (lease with 12 month term or less) | 0 | 21 | 0 | 116 |
Total lease expense | $ 209 | $ 172 | $ 595 | $ 458 |
Commitment and Contingencies -
Commitment and Contingencies - Summary of Minimum Lease Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
2022 (remaining three months, net of landlord credits) | $ 0 | |
2023 | 736 | |
2024 | 66 | |
2025 | 0 | |
2026 | 0 | |
Total future lease payments, undiscounted | 802 | |
(Less): Imputed interest | (61) | |
Present value of operating lease payments | $ 741 | $ 1,194 |
Commitment & Contingencies - In
Commitment & Contingencies - In-License Agreement for Lotilaner (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 15 Months Ended | |||||||||
Mar. 26, 2021 | Jun. 30, 2022 | Apr. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jan. 31, 2019 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development | $ 10,912,000 | $ 10,209,000 | $ 32,596,000 | $ 33,674,000 | |||||||||
Common stock issued for license agreement, value | $ 5,494,000 | 0 | $ 5,494,000 | ||||||||||
License agreement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development | $ 2,000,000 | $ 1,000,000 | |||||||||||
Common stock issued for license agreement (shares) | 222,460 | ||||||||||||
Common stock issued for license agreement, value | $ 3,100,000 | ||||||||||||
Common stock issued for license agreement, share price (usd per share) | $ 14.0003 | ||||||||||||
Additional shares to be issued upon 18-month anniversary of contract execution (shares) | 187,500 | ||||||||||||
Additional shares to be issued upon 18-month anniversary of contract execution, value | $ 5,500,000 | ||||||||||||
Additional shares to be issued upon 18-month anniversary of contract execution, share price (usd per share) | $ 29.30 | ||||||||||||
License agreement | LianBio | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Upfront payment received | $ 25,000,000 | $ 25,000,000 | $ 70,000,000 | ||||||||||
License agreement | Elanco | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development | $ 1,500,000 | ||||||||||||
Upfront payment received | $ 2,500,000 | ||||||||||||
License agreement | Clinical milestones | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development | $ 1,000,000 | ||||||||||||
Maximum milestone payments | 3,000,000 | 4,500,000 | 4,500,000 | ||||||||||
License agreement | Commercial and sales milestones | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Maximum milestone payments | $ 79,000,000 | $ 77,000,000 | $ 77,000,000 |
Commitment & Contingencies - Em
Commitment & Contingencies - Employment Arrangements (Details) | Sep. 30, 2022 arrangement |
Commitments and Contingencies Disclosure [Abstract] | |
Number of employment arrangements with executive officers | 8 |
Out-License Agreement (Details)
Out-License Agreement (Details) - LianBio - License agreement - USD ($) $ in Millions | 3 Months Ended | 15 Months Ended | ||||
Nov. 08, 2022 | Nov. 01, 2022 | Mar. 26, 2021 | Jun. 30, 2021 | Jun. 30, 2022 | Sep. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Upfront payment received | $ 25 | $ 25 | $ 70 | |||
Clinical development milestones | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Milestone payment achieved | $ 45 | |||||
Development and Regulatory Milestone | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Maximum milestone payments | $ 30 | |||||
Development and Regulatory Milestone | Subsequent Event | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Milestone payment achieved | $ 10 | $ 10 | ||||
Drug Supply Agreement Milestone | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Maximum milestone payments | 5 | |||||
Sales-Based Milestone | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Maximum milestone payments | $ 100 |
Credit Facility Agreement (Deta
Credit Facility Agreement (Details) - USD ($) $ in Thousands | 9 Months Ended | |||
Sep. 30, 2022 | Feb. 02, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | ||||
Principal outstanding | $ 20,000 | $ 20,000 | ||
Debt issuance costs | $ 875 | 875 | ||
Line of Credit | ||||
Debt Instrument [Line Items] | ||||
Credit facility, aggregate principal amount | $ 175,000 | |||
Increments to draw on credit facility at company's election | $ 5,000 | |||
Interest rate | 8.45% | |||
Interest rate | 6.25% | 3.25% | ||
Principal outstanding | $ 20,000 | 20,000 | $ 0 | |
End of term charge | 1,000 | |||
End of term charge, interest rate | 4.75% | |||
Debt issuance costs | $ 900 | $ 900 | ||
Effective interest rate | 12.37% | 12.37% | ||
Line of Credit | Prime Rate | ||||
Debt Instrument [Line Items] | ||||
Basis spread on variable rate | 5.20% | |||
Line of Credit | Credit Facility, Tranche One | ||||
Debt Instrument [Line Items] | ||||
Credit facility, aggregate principal amount | $ 40,000 | |||
Line of Credit | Credit Facility, Tranche Two | ||||
Debt Instrument [Line Items] | ||||
Credit facility, aggregate principal amount | 20,000 | |||
Line of Credit | Credit Facility, Tranche Three | ||||
Debt Instrument [Line Items] | ||||
Credit facility, aggregate principal amount | 25,000 | |||
Line of Credit | Credit Facility, Tranche Four | ||||
Debt Instrument [Line Items] | ||||
Credit facility, aggregate principal amount | 35,000 | |||
Line of Credit | Credit Facility, Tranche Five | ||||
Debt Instrument [Line Items] | ||||
Credit facility, aggregate principal amount | 50,000 | |||
Line of Credit | Credit Facility, Tranche Six | ||||
Debt Instrument [Line Items] | ||||
Credit facility, aggregate principal amount | $ 25,000 |
Credit Facility Agreement - Sum
Credit Facility Agreement - Summary of Interest Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Debt Disclosure [Abstract] | ||
Interest expense for term loan | $ 539 | $ 1,275 |
Accretion of end of term charge | 48 | 127 |
Amortization of debt issuance costs | 46 | 105 |
Total interest expense related to term loan | $ 633 | $ 1,507 |
Credit Facility Agreement - Bal
Credit Facility Agreement - Balances of Debt, Debt Issuance Costs, and Accumulated Accretion (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Debt Disclosure [Abstract] | |
Term loan, gross (amount drawn) | $ 20,000 |
Debt issuance costs (legal and other administrative fees) | (875) |
Accretion of end of term charge | 127 |
Accumulated amortization of debt issuance costs | 104 |
Term loan, net | $ 19,356 |
Subsequent Event (Details)
Subsequent Event (Details) - USD ($) $ in Millions | Nov. 08, 2022 | Nov. 01, 2022 |
Subsequent Event | Development and Regulatory Milestone | LianBio | License agreement | ||
Subsequent Event [Line Items] | ||
Milestone payment achieved | $ 10 | $ 10 |