Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-37581 | |
Entity Registrant Name | Aclaris Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-0571712 | |
Entity Address, Address Line One | 701 Lee Road, Suite 103 | |
Entity Address, City or Town | Wayne | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19087 | |
City Area Code | 484 | |
Local Phone Number | 324-7933 | |
Title of 12(b) Security | Common Stock, $0.00001 par value | |
Trading Symbol | ACRS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 70,836,194 | |
Entity Central Index Key | 0001557746 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 39,040 | $ 45,277 |
Short-term marketable securities | 64,012 | 172,294 |
Accounts receivable, net | 346 | 484 |
Prepaid expenses and other current assets | 19,670 | 13,495 |
Total current assets | 123,068 | 231,550 |
Marketable securities | 83,944 | 12,242 |
Property and equipment, net | 1,764 | 1,099 |
Intangible assets | 6,917 | 6,973 |
Other assets | 2,661 | 2,732 |
Total Assets | 218,354 | 254,596 |
Current liabilities: | ||
Accounts payable | 9,648 | 10,351 |
Accrued expenses | 15,160 | 8,701 |
Current portion of lease liabilities | 310 | 684 |
Discontinued operations | 2,202 | 2,202 |
Total current liabilities | 27,320 | 21,938 |
Other liabilities | 1,834 | 1,570 |
Contingent consideration | 32,500 | 33,100 |
Deferred tax liability | 367 | 367 |
Total liabilities | 62,021 | 56,975 |
Commitments and contingencies (Note 14) | ||
Stockholders' Equity: | ||
Preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued or outstanding at September 30, 2023 and December 31, 2022 | ||
Common stock, $0.00001 par value; 200,000,000 and 100,000,000 shares authorized at September 30, 2023 and December 31, 2022, respectively; 70,818,954 and 66,688,647 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 1 | 1 |
Additional paid-in capital | 926,766 | 880,832 |
Accumulated other comprehensive loss | (1,129) | (897) |
Accumulated deficit | (769,305) | (682,315) |
Total stockholders' equity | 156,333 | 197,621 |
Total liabilities and stockholders' equity | $ 218,354 | $ 254,596 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 200,000,000 | 100,000,000 |
Common stock, shares issued | 70,818,954 | 66,688,647 |
Common stock, shares outstanding | 70,818,954 | 66,688,647 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Total revenue | $ 9,282 | $ 19,018 | $ 13,679 | $ 21,999 |
Costs and expenses: | ||||
Cost of revenue | 848 | 923 | 2,698 | 3,146 |
Research and development | 23,876 | 23,656 | 71,738 | 56,741 |
General and administrative | 7,091 | 5,813 | 24,198 | 17,987 |
Licensing | 7,344 | 7,300 | 8,955 | 7,300 |
Revaluation of contingent consideration | 1,700 | 2,200 | (600) | (2,400) |
Total costs and expenses | 40,859 | 39,892 | 106,989 | 82,774 |
Loss from operations | (31,577) | (20,874) | (93,310) | (60,775) |
Other income, net | 2,316 | 922 | 6,320 | 1,502 |
Net loss | $ (29,261) | $ (19,952) | $ (86,990) | $ (59,273) |
Net loss per share, basic | $ (0.41) | $ (0.30) | $ (1.25) | $ (0.92) |
Net loss per share, diluted | $ (0.41) | $ (0.30) | $ (1.25) | $ (0.92) |
Weighted average common shares outstanding, basic | 70,807,934 | 66,675,337 | 69,452,495 | 64,718,008 |
Weighted average common shares outstanding, diluted | 70,807,934 | 66,675,337 | 69,452,495 | 64,718,008 |
Other comprehensive loss: | ||||
Unrealized loss on marketable securities, net of tax of $0 | $ (18) | $ (139) | $ (232) | $ (1,241) |
Total other comprehensive loss | (18) | (139) | (232) | (1,241) |
Comprehensive loss | (29,279) | (20,091) | (87,222) | (60,514) |
Contract research | ||||
Revenues: | ||||
Total revenue | 705 | 1,090 | 2,469 | 3,529 |
Licensing | ||||
Revenues: | ||||
Total revenue | $ 8,577 | 17,898 | $ 11,210 | 18,378 |
Other | ||||
Revenues: | ||||
Total revenue | $ 30 | $ 92 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
Unrealized loss on marketable securities, tax | $ 0 | $ 0 | $ 0 | $ 0 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Balance at beginning of period at Dec. 31, 2021 | $ 1 | $ 792,971 | $ (224) | $ (595,407) | $ 197,341 |
Balance at beginning of period (in shares) at Dec. 31, 2021 | 61,228,446 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units | 49 | 49 | |||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units (in shares) | 509,037 | ||||
Unrealized gain (loss) on marketable securities | (748) | (748) | |||
Stock-based compensation expense | 2,346 | 2,346 | |||
Net loss | (18,789) | (18,789) | |||
Balance at end of period at Mar. 31, 2022 | $ 1 | 795,366 | (972) | (614,196) | 180,199 |
Balance at end of period (in shares) at Mar. 31, 2022 | 61,737,483 | ||||
Balance at beginning of period at Dec. 31, 2021 | $ 1 | 792,971 | (224) | (595,407) | 197,341 |
Balance at beginning of period (in shares) at Dec. 31, 2021 | 61,228,446 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (59,273) | ||||
Balance at end of period at Sep. 30, 2022 | $ 1 | 875,982 | (1,465) | (654,680) | 219,838 |
Balance at end of period (in shares) at Sep. 30, 2022 | 66,679,641 | ||||
Balance at beginning of period at Mar. 31, 2022 | $ 1 | 795,366 | (972) | (614,196) | 180,199 |
Balance at beginning of period (in shares) at Mar. 31, 2022 | 61,737,483 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units | 88 | 88 | |||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units (in shares) | 91,388 | ||||
Issuance of common stock under at-the-market sales agreement, net of offering costs | 72,659 | 72,659 | |||
Issuance of common stock under at-the-market sales agreement, net of offering costs (in shares) | 4,838,709 | ||||
Unrealized gain (loss) on marketable securities | (354) | (354) | |||
Stock-based compensation expense | 3,692 | 3,692 | |||
Net loss | (20,532) | (20,532) | |||
Balance at end of period at Jun. 30, 2022 | $ 1 | 871,805 | (1,326) | (634,728) | 235,752 |
Balance at end of period (in shares) at Jun. 30, 2022 | 66,667,580 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units | (11) | (11) | |||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units (in shares) | 12,061 | ||||
Unrealized gain (loss) on marketable securities | (139) | (139) | |||
Stock-based compensation expense | 4,188 | 4,188 | |||
Net loss | (19,952) | (19,952) | |||
Balance at end of period at Sep. 30, 2022 | $ 1 | 875,982 | (1,465) | (654,680) | 219,838 |
Balance at end of period (in shares) at Sep. 30, 2022 | 66,679,641 | ||||
Balance at beginning of period at Dec. 31, 2022 | $ 1 | 880,832 | (897) | (682,315) | $ 197,621 |
Balance at beginning of period (in shares) at Dec. 31, 2022 | 66,688,647 | 66,688,647 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units (in shares) | 517,378 | ||||
Unrealized gain (loss) on marketable securities | 543 | $ 543 | |||
Stock-based compensation expense | 6,806 | 6,806 | |||
Net loss | (28,160) | (28,160) | |||
Balance at end of period at Mar. 31, 2023 | $ 1 | 887,638 | (354) | (710,475) | 176,810 |
Balance at end of period (in shares) at Mar. 31, 2023 | 67,206,025 | ||||
Balance at beginning of period at Dec. 31, 2022 | $ 1 | 880,832 | (897) | (682,315) | $ 197,621 |
Balance at beginning of period (in shares) at Dec. 31, 2022 | 66,688,647 | 66,688,647 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | $ (86,990) | ||||
Balance at end of period at Sep. 30, 2023 | $ 1 | 926,766 | (1,129) | (769,305) | $ 156,333 |
Balance at end of period (in shares) at Sep. 30, 2023 | 70,818,954 | 70,818,954 | |||
Balance at beginning of period at Mar. 31, 2023 | $ 1 | 887,638 | (354) | (710,475) | $ 176,810 |
Balance at beginning of period (in shares) at Mar. 31, 2023 | 67,206,025 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units | 30 | 30 | |||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units (in shares) | 163,677 | ||||
Issuance of common stock under at-the-market sales agreement, net of offering costs | 26,714 | 26,714 | |||
Issuance of common stock under at-the-market sales agreement, net of offering costs (in shares) | 3,400,000 | ||||
Unrealized gain (loss) on marketable securities | (757) | (757) | |||
Stock-based compensation expense | 6,522 | 6,522 | |||
Net loss | (29,569) | (29,569) | |||
Balance at end of period at Jun. 30, 2023 | $ 1 | 920,904 | (1,111) | (740,044) | 179,750 |
Balance at end of period (in shares) at Jun. 30, 2023 | 70,769,702 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units | (86) | (86) | |||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units (in shares) | 49,252 | ||||
Unrealized gain (loss) on marketable securities | (18) | (18) | |||
Stock-based compensation expense | 5,948 | 5,948 | |||
Net loss | (29,261) | (29,261) | |||
Balance at end of period at Sep. 30, 2023 | $ 1 | $ 926,766 | $ (1,129) | $ (769,305) | $ 156,333 |
Balance at end of period (in shares) at Sep. 30, 2023 | 70,818,954 | 70,818,954 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
At The Market Offering | ||
Offering costs netted against proceeds | $ 826 | $ 2,341 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (86,990) | $ (59,273) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 635 | 607 |
Stock-based compensation expense | 19,276 | 10,226 |
Revaluation of contingent consideration | (600) | (2,400) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 138 | 26 |
Prepaid expenses and other assets | (9,293) | 3,408 |
Accounts payable | (1,079) | (2,319) |
Accrued expenses | 6,349 | 1,273 |
Net cash used in operating activities | (71,564) | (48,452) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (868) | (500) |
Purchases of marketable securities | (135,675) | (118,729) |
Proceeds from sales and maturities of marketable securities | 175,213 | 129,155 |
Net cash provided by investing activities | 38,670 | 9,926 |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock under the at-the-market sales agreement, net of issuance costs | 26,714 | 72,744 |
Payments of employee withholding taxes related to restricted stock unit award vesting | (102) | (34) |
Proceeds from exercise of employee stock options and the issuance of stock | 45 | 120 |
Net cash provided by financing activities | 26,657 | 72,830 |
Net (decrease) increase in cash and cash equivalents | (6,237) | 34,304 |
Cash and cash equivalents at beginning of period | 45,277 | 27,349 |
Cash and cash equivalents at end of period | 39,040 | 61,653 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Additions to property and equipment included in accounts payable | $ 376 | $ 4 |
Organization and Nature of Busi
Organization and Nature of Business | 9 Months Ended |
Sep. 30, 2023 | |
Organization and Nature of Business | |
Organization and Nature of Business | 1. Organization and Nature of Business Overview Aclaris Therapeutics, Inc. was incorporated under the laws of the State of Delaware in 2012. In 2017, Confluence Life Sciences, Inc. (now known as Aclaris Life Sciences, Inc.) (“Confluence”) was acquired by Aclaris Therapeutics, Inc. and became a wholly owned subsidiary thereof. Aclaris Therapeutics, Inc. and its wholly owned subsidiaries are referred to collectively as the “Company.” The Company is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases. In addition to developing its novel drug candidates, the Company is pursuing strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for and/or commercialize its novel drug candidates. Liquidity The Company’s condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. As of September 30, 2023, the Company had cash, cash equivalents and marketable securities of $187.0 million and an accumulated deficit of $769.3 million. Since inception, the Company has incurred net losses and negative cash flows from its operations. Prior to the acquisition of Confluence, the Company had never generated revenue. There can be no assurance that profitable operations will ever be achieved, and, if achieved, will be sustained on a continuing basis. In addition, development activities, including clinical and preclinical testing of the Company’s drug candidates, will require significant additional financing. The future viability of the Company is dependent on its ability to successfully develop its drug candidates and to generate revenue from identifying and consummating transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize its development assets or to raise additional capital to finance its operations. The Company will require additional capital to complete the clinical development of zunsemetinib (ATI-450), ATI-1777, ATI-2138 and ATI-2231, to develop its preclinical compounds, and to support its discovery efforts. Additional funds may not be available on a timely basis, on commercially acceptable terms, or at all, and such funds, if raised, may not be sufficient to enable the Company to continue to implement its long-term business strategy. The Company's ability to raise additional capital may be adversely impacted by potential worsening global economic conditions caused by a variety of factors including geopolitical tensions, rising interest rates, the closure of financial institutions and inflationary pressures. If the Company is unable to raise sufficient additional capital or generate revenue from transactions with potential third-party partners for the development and/or commercialization of its drug candidates, it may need to substantially curtail planned operations. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. In accordance with Accounting Standards Codification (“ASC”) Subtopic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that its condensed consolidated financial statements are issued. As of the report date, the Company does not believe that substantial doubt exists about its ability to continue as a going concern. The Company believes its existing cash, cash equivalents and marketable securities are sufficient to fund its operating and capital expenditure requirements for a period greater than 12 months from the date of issuance of these condensed consolidated financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated statement of stockholders’ equity for the three and nine months ended September 30, 2023 and 2022, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements contained in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 23, 2023 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the Company’s financial position as of September 30, 2023, the results of its operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, its changes in stockholders’ equity for the three and nine months ended September 30, 2023 and 2022 and its cash flows for the nine months ended September 30, 2023 and 2022. The condensed consolidated balance sheet data as of December 31, 2022 was derived from audited financial statements but does not include all disclosures required by generally accepted accounting principles in the United States (“GAAP”). The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2023 and 2022 are unaudited. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. The unaudited interim financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 23, 2023. Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with GAAP. The condensed consolidated financial statements of the Company include the accounts of the operating parent company, Aclaris Therapeutics, Inc., and its wholly owned subsidiaries. All intercompany transactions have been eliminated. Based upon the Company’s revenue, the Company believes that gross profit does not provide a meaningful measure of profitability and, therefore, has not included a line item for gross profit on the condensed consolidated statement of operations. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, contingent consideration and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require an update to its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from the Company’s estimates. Reclassifications Certain prior year amounts have been reclassified to conform to the current year’s financial statement presentation. Concentration of Credit Risk and of Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company holds all cash, cash equivalents and marketable securities balances at three accredited financial institutions, the majority of which are in amounts that exceed or are not subject to federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company is dependent on third-party manufacturers to supply drug product, including all underlying components, for its research and development activities, including preclinical and clinical testing. These activities could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients or other components. Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 23, 2023. There have been no changes to the Company’s significant accounting policies from those disclosed in the annual report. Contingent Consideration The Company initially recorded a contingent consideration liability at fair value on the date of acquisition related to future potential payments resulting from the acquisition of Confluence based upon significant unobservable inputs including the achievement of development, regulatory and commercial milestones, as well as estimated future sales levels and the discount rates applied to calculate the present value of the potential payments. Significant judgement was involved in determining the appropriateness of these assumptions. These assumptions are considered Level 3 inputs. Revaluation of the contingent consideration liability can result from changes to one or more of these assumptions. The Company evaluates the fair value estimate of the contingent consideration liability on a quarterly basis with changes, if any, recorded as income or expense in the condensed consolidated statement of operations. The fair value of contingent consideration is estimated using a probability-weighted expected payment model for regulatory milestone payments and a Monte Carlo simulation model for commercial milestone and royalty payments and then applying a risk-adjusted discount rate to calculate the present value of the potential payments. Significant assumptions used in the Company’s estimates include the probability of achieving regulatory milestones and commencing commercialization, which are based on an asset’s current stage of development and a review of existing clinical data. Probability of success on the year of each potential payment. Revenue Recognition The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition in accordance with ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) performance obligations are satisfied. At contract inception, the Company assesses the goods or services promised within a contract with a customer to identify the performance obligations, and to determine if they are distinct. The Company recognizes the revenue that is allocated to each distinct performance obligation when (or as) that performance obligation is satisfied. The Company only recognizes revenue when collection of the consideration it is entitled to under a contract with a customer is probable. Contract Research Licensing Licenses of Intellectual Property Milestone and Royalty Payments The Company recognizes revenue from development, regulatory and anniversary milestone payments as they are achieved. The Company recognizes revenue from commercial milestones and royalty payments as the sales occur. Discontinued Operations In September 2019, the Company announced the completion of a strategic review and its decision to refocus its resources on its immuno-inflammatory development programs and to actively seek partners for its commercial products. As of September 30, 2023 and December 31, 2022, the Company had $2.2 million in accrued expenses reported as discontinued operations in the Company’s consolidated balance sheet. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value of Financial Assets and Liabilities | |
Fair Value of Financial Assets and Liabilities | 3. Fair Value of Financial Assets and Liabilities The following tables present information about the fair value measurements of the Company’s financial assets and liabilities which are measured at fair value on a recurring and non-recurring basis, and indicate the level of the fair value hierarchy utilized to determine such fair values: September 30, 2023 (In thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 35,593 $ — $ — $ 35,593 Marketable securities — 147,956 — 147,956 Total assets $ 35,593 $ 147,956 $ — $ 183,549 Liabilities: Contingent consideration $ — $ — $ 32,500 $ 32,500 Total liabilities $ — $ — $ 32,500 $ 32,500 December 31, 2022 (In thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 38,516 $ — $ — $ 38,516 Marketable securities — 184,536 — 184,536 Total assets $ 38,516 $ 184,536 $ — $ 223,052 Liabilities: Contingent consideration $ — $ — $ 33,100 $ 33,100 Total liabilities $ — $ — $ 33,100 $ 33,100 As of September 30, 2023, the Company’s cash equivalents consisted of a money market fund and treasury bills, which were valued based upon Level 1 inputs. As of December 31, 2022, the Company’s cash equivalents consisted of a money market fund, which was valued based upon Level 1 inputs. The Company’s marketable securities as of September 30, 2023 consisted of commercial paper, treasury bills, and corporate debt, asset-backed debt, foreign government agency debt and U.S. government and government agency debt securities, which were all valued based upon Level 2 inputs. The Company’s marketable securities as of December 31, 2022 consisted of commercial paper and corporate debt, asset-backed debt and U.S. government and government agency debt securities, which were all valued based upon Level 2 inputs. In determining the fair value of its Level 2 investments, the Company relies on quoted prices for identical securities in markets that are not active. These quoted prices are obtained by the Company with the assistance of a third-party pricing service based on available trade, bid and other observable market data for identical securities. During the three and nine months ended September 30, 2023 and 2022, there were no transfers into or out of Level 3. The overall $0.6 million decrease in the fair value of the contingent consideration liability during the nine months ended September 30, 2023 was primarily due to the removal of estimated sales levels from zunsemetinib (ATI-450) for moderate to severe hidradenitis suppurativa following the Company’s decision to cease pursuing this indication, as well as higher discount rates resulting from higher risk-free rates and changes in credit spreads being applied to potential payments relative to prior periods. This decrease was partially offset by an increase in the probability of success of ATI-2138, as well as the passage of time. As of September 30, 2023 and December 31, 2022, the fair value of the Company’s available-for-sale marketable securities by type of security was as follows: September 30, 2023 Gross Gross Book Unrealized Unrealized Fair (In thousands) Value Gain Loss Value Marketable securities: Corporate debt securities (1) $ 52,169 $ — $ (463) $ 51,706 Commercial paper 14,663 — (31) 14,632 Treasury bills 4,936 1 — 4,937 Asset-backed debt securities (2) 11,349 8 (21) 11,336 Foreign government agency debt securities (3) 4,659 — (18) 4,641 U.S. government and government agency debt securities (4) 61,315 — (611) 60,704 Total marketable securities $ 149,091 $ 9 $ (1,144) $ 147,956 (1) Included in Corporate debt securities is $27.5 million with maturity dates between one and two years . (2) Included in Asset-backed debt securities is $11.3 million with maturity dates between two and four years . (3) Included in Foreign government agency debt securities is $4.6 million with a maturity date between one and two years . (4) Included in U.S. government and government agency debt securities is $40.5 million with maturity dates between one and two years . December 31, 2022 Gross Gross Book Unrealized Unrealized Fair (In thousands) Value Gain Loss Value Marketable securities: Corporate debt securities (1) $ 40,626 $ — $ (251) $ 40,375 Commercial paper 79,598 — — 79,598 Asset-backed debt securities (2) 14,641 4 (123) 14,522 U.S. government and government agency debt securities (3) 50,571 — (530) 50,041 Total marketable securities $ 185,436 $ 4 $ (904) $ 184,536 (1) Included in Corporate debt securities is $4.8 million with maturity dates between one and five years . (2) Included in Asset-backed debt securities is $2.4 million with maturity dates between one and five years . (3) Included in U.S. government and government agency debt securities is $5.0 million with maturity dates between one and five years . |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2023 | |
Property and Equipment, Net | |
Property and Equipment, Net | 4. Property and Equipment, Net Property and equipment, net consisted of the following: September 30, December 31, (In thousands) 2023 2022 Computer equipment $ 1,444 $ 1,381 Lab equipment 3,152 2,010 Furniture and fixtures 649 620 Leasehold improvements 1,123 1,123 Property and equipment, gross 6,368 5,134 Accumulated depreciation (4,604) (4,035) Property and equipment, net $ 1,764 $ 1,099 Depreciation expense was $0.2 million for each of the three months ended September 30, 2023 and 2022, and $0.6 million for each of the nine months ended September 30, 2023 and 2022. |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2023 | |
Intangible Assets | |
Intangible Assets | 5. Intangible Assets Intangible assets consisted of the following: Gross Cost Accumulated Amortization Remaining September 30, December 31, September 30, December 31, (In thousands, except years) Life (years) 2023 2022 2023 2022 Other intangible assets 3.8 $ 751 $ 751 $ 463 $ 407 In-process research and development n/a 6,629 6,629 — — Total intangible assets $ 7,380 $ 7,380 $ 463 $ 407 Amortization expense was $19 thousand for each of the three months ended September 30, 2023 and 2022, and $56 thousand for each of the nine months ended September 30, 2023 and 2022. As of September 30, 2023, estimated future amortization expense was as follows: Year Ending (In thousands) December 31, 2023 $ 19 2024 75 2025 75 2026 75 2027 44 Total $ 288 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consisted of the following: September 30, December 31, (In thousands) 2023 2022 Employee compensation expenses $ 4,968 $ 5,295 Research and development expenses 2,985 2,689 Licensing expenses 6,647 500 Other 560 217 Total accrued expenses $ 15,160 $ 8,701 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | 7. Stockholders’ Equity Preferred Stock As of September 30, 2023 and December 31, 2022, the Company’s amended and restated certificate of incorporation (the “Charter”) authorized the Company to issue 10,000,000 shares of undesignated preferred stock. There were no shares of preferred stock outstanding as of September 30, 2023 or December 31, 2022. Common Stock On June 1, 2023, at the 2023 Annual Meeting of Stockholders, the Company’s stockholders approved an amendment to the Charter to increase the authorized number of shares of common stock from 100,000,000 shares to 200,000,000 shares. On June 1, 2023, the Company filed a Certificate of Amendment to the Charter with the Secretary of State of the State of Delaware, which became effective upon filing. As of September 30, 2023 and December 31, 2022, the Company’s Charter authorized the Company to issue 200,000,000 and 100,000,000 shares, respectively, of $0.00001 par value common stock. There were 70,818,954 and 66,688,647 shares of common stock issued outstanding Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to any preferential dividend rights of any series of preferred stock that may be outstanding. No dividends have been declared through September 30, 2023. Sales of Common Stock Pursuant to At-The-Market Facility In April 2023, the Company sold 3.4 million shares of its common stock for aggregate gross proceeds of $27.5 million, pursuant to a sales agreement with SVB Securities LLC and Cantor Fitzgerald & Co., as sales agents, dated February 23, 2023. The Company paid selling commissions of $0.8 million in connection with the sale. In April 2022, the Company sold 4.8 million shares of its common stock for aggregate gross proceeds of $75.0 million, pursuant to a sales agreement with SVB Securities LLC and Cantor Fitzgerald & Co., as sales agents, dated May 20, 2021. The Company paid selling commissions and other fees of $2.3 million in connection with the sale. |
Stock-Based Awards
Stock-Based Awards | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Awards | |
Stock-Based Awards | 8. Stock-Based Awards 2015 Equity Incentive Plan In September 2015, the Company’s board of directors adopted the 2015 Equity Incentive Plan (the “2015 Plan”), and the Company’s stockholders approved the 2015 Plan. The 2015 Plan became effective in connection with the Company’s initial public offering in October 2015. Beginning at the time the 2015 Plan became effective, no 2017 Inducement Plan In July 2017, the Company’s board of directors adopted the 2017 Inducement Plan (the “2017 Inducement Plan”). The 2017 Inducement Plan is a non-stockholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq listing rules. The Company had 370,600 stock options outstanding as of September 30, 2023 under the 2017 Inducement Plan. All shares of common stock that were eligible for issuance under the 2017 Inducement Plan after October 1, 2018, including any shares underlying any awards that expire or are otherwise terminated, reacquired to satisfy tax withholding obligations, settled in cash or repurchased by the Company in the future that would have been eligible for re-issuance under the 2017 Inducement Plan, were retired. 2012 Equity Compensation Plan Upon the 2015 Plan becoming effective, no further grants can be made under the 2012 Plan. The Company had 456,208 stock options outstanding as of September 30, 2023 under the 2012 Plan. Stock Option Valuation The weighted average assumptions the Company used to estimate the fair value of stock options granted during the nine months ended September 30, 2023 and 2022 were as follows: Nine Months Ended September 30, 2023 2022 Risk-free interest rate 3.53 % 2.07 % Expected term (in years) 6.2 6.2 Expected volatility 77.73 % 77.95 % Expected dividend yield 0 % 0 % The Company recognizes compensation expense for awards over their vesting period. Compensation expense for awards includes the impact of forfeitures in the period when they occur. Stock Options The following table summarizes stock option activity for the nine months ended September 30, 2023: Weighted Weighted Average Average Remaining Aggregate Number Exercise Contractual Intrinsic (In thousands, except share and per share data and years) of Shares Price Term Value (in years) Outstanding as of December 31, 2022 5,167,164 $ 16.04 7.2 $ 15,288 Granted 2,218,550 15.71 Exercised (34,269) 1.30 $ 319 Forfeited and cancelled (228,990) 15.71 Outstanding as of September 30, 2023 7,122,455 $ 16.02 7.1 $ 3,680 Options vested and expected to vest as of September 30, 2023 7,122,455 $ 16.02 7.1 $ 3,680 Options exercisable as of September 30, 2023 3,190,762 $ 16.70 4.7 $ 3,323 The weighted average grant date fair value of stock options granted during the nine months ended September 30, 2023 was $11.04 per share. Restricted Stock Units The following table summarizes RSU activity for the nine months ended September 30, 2023: Weighted Average Grant Date Aggregate Number Fair Value Intrinsic (In thousands, except share and per share data) of Shares Per Share Value Outstanding as of December 31, 2022 1,520,730 $ 14.02 Granted 980,700 15.32 Vested (706,167) 11.61 $ 8,141 Forfeited and cancelled (88,073) 15.68 Outstanding as of September 30, 2023 1,707,190 $ 15.68 Stock-Based Compensation Stock-based compensation expense included in total costs and expenses on the condensed consolidated statement of operations included the following: Three Months Ended Nine Months Ended September 30, September 30, (In thousands) 2023 2022 2023 2022 Cost of revenue $ 347 $ 307 $ 1,119 $ 837 Research and development 3,072 1,400 9,168 2,228 General and administrative 2,529 2,481 8,989 7,161 Total stock-based compensation expense $ 5,948 $ 4,188 $ 19,276 $ 10,226 As of September 30, 2023, the Company had unrecognized stock-based compensation expense for stock options and RSUs of $35.6 million and $21.7 million, respectively, which is expected to be recognized over weighted average periods of 2.9 |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss per Share | |
Net Loss per Share | 9. Net Loss per Share Basic and diluted net loss per share is summarized in the following table: Three Months Ended Nine Months Ended September 30, September 30, (In thousands, except for share and per share data) 2023 2022 2023 2022 Numerator: Net loss $ (29,261) $ (19,952) $ (86,990) $ (59,273) Denominator: Weighted average shares of common stock outstanding, basic and diluted 70,807,934 66,675,337 69,452,495 64,718,008 Net loss per share, basic and diluted $ (0.41) $ (0.30) $ (1.25) $ (0.92) The Company’s potentially dilutive securities, which include stock options and RSUs, have been excluded from the computation of diluted net loss per share since the effect would be to reduce the net loss per share. Therefore, the weighted average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share is the same. The following table presents potential shares of common stock excluded from the calculation of diluted net loss per share for the nine months ended September 30, 2023 and 2022. All share amounts presented in the table below represent the total number outstanding as of September 30, 2023 and 2022. September 30, 2023 2022 Options to purchase common stock 7,122,455 5,187,664 Restricted stock unit awards 1,707,190 1,585,184 Total potential shares of common stock 8,829,645 6,772,848 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Leases | 10. Leases Operating Leases Agreements for Office and Laboratory Space The Company had a sublease agreement pursuant to which it subleased 33,019 square feet of office space for its headquarters in Wayne, Pennsylvania. The sublease expired on October 31, 2023. In December 2020, the Company entered into a sub-sublease agreement under which it sub-subleased 8,115 square feet to a third party. The sub-sublease was terminated in December 2022. In May 2023, the Company entered into a new lease agreement pursuant to which it leases 11,564 square feet of office space for its headquarters in Wayne, Pennsylvania. The lease commenced on November 1, 2023 and has a term that runs through March 2029. In February 2019, the Company entered into a sublease agreement pursuant to which it subleases 20,433 square feet of office and laboratory space in St. Louis, Missouri. The lease commenced in June 2019 and has a term that runs through June 2029. In January 2023, the Company amended the sublease agreement to add an additional 6,261 square feet of office and laboratory space effective February 2023, which term runs concurrently with the existing term. Supplemental balance sheet information related to operating leases is as follows: September 30, December 31, (In thousands) 2023 2022 Operating Leases: Gross cost $ 5,804 $ 5,240 Accumulated amortization (3,220) (2,560) Other assets $ 2,584 $ 2,680 Current portion of lease liabilities $ 310 $ 684 Other liabilities 1,834 1,570 Total operating lease liabilities $ 2,144 $ 2,254 Amortization expense related to operating lease right-of-use assets and accretion of operating lease liabilities totaled $0.2 million and $0.3 million for the three months ended September 30, 2023 and 2022, respectively, and $0.7 million and $0.8 million for the nine months ended September 30, 2023 and 2022, respectively. |
Agreements Related to Intellect
Agreements Related to Intellectual Property | 9 Months Ended |
Sep. 30, 2023 | |
Agreements Related to Intellectual Property | |
Agreements Related to Intellectual Property | 11. Agreements Related to Intellectual Property License Agreement – Pediatrix Therapeutics, Inc. In November 2022, the Company entered into a license agreement with Pediatrix Therapeutics, Inc. (“Pediatrix”), under which the Company granted Pediatrix the exclusive rights to develop, manufacture and commercialize ATI-1777 in Greater China. Pediatrix has agreed to pay the Company an upfront payment, development, regulatory and commercial milestone payments, and a tiered royalty ranging from a low-to-high single digit percentage of net sales of ATI-1777 by Pediatrix in Greater China. A portion of consideration received from Pediatrix is payable to the former Confluence equity holders as described below. License Agreement – Eli Lilly and Company In August 2022, the Company entered into a non-exclusive patent license agreement with Eli Lilly and Company (“Lilly”). Under the license agreement, the Company granted Lilly non-exclusive rights under certain patents and patent applications that the Company exclusively licenses from a third party. The patents and patent applications relate to the use of baricitinib, Lilly’s JAK inhibitor, to treat alopecia areata. Under the license agreement, Lilly has agreed to pay the Company an upfront payment, regulatory and commercial milestone payments, anniversary payments, and a low single- digit royalty calculated as a percentage of Lilly’s net sales of baricitinib for the treatment of alopecia areata. The Company has separate contractual obligations under which the Company has agreed to pay to third parties an amount equal to any regulatory and commercial milestone payments it receives under the Lilly license agreement, as well as a portion of the upfront consideration and a portion of the royalties it may receive under the license agreement. The Company recorded licensing revenue under this agreement of $8.3 million and $10.7 million during the three and nine months ended September 30, 2023, respectively. Of these amounts, $7.3 million and $9.0 million were payable to third parties during the three and nine months ended September 30, 2023, respectively, and recorded as licensing expense. The Company recorded licensing revenue under this agreement of $17.6 million for each of the three and nine months ended September 30, 2022. Of this amount, $7.3 million was payable to third parties and recorded as licensing expense. Asset Purchase Agreement – EPI Health, LLC In October 2019, the Company sold RHOFADE (oxymetazoline hydrochloride) cream, 1% (“RHOFADE”) to EPI Health, LLC (“EPI Health”) pursuant to an asset purchase agreement. EPI Health agreed to pay the Company a high single-digit royalty calculated as a percentage of net sales on a country-by-country basis until the date that the patent rights related to RHOFADE have expired or, if later, ten years from the date of the first commercial sale of RHOFADE in such country. EPI Health also agreed to pay the Company potential sales milestone payments of up to $20.0 million in the aggregate upon the achievement of specified levels of net sales of products covered by the asset purchase agreement, and 25% of any upfront, license, milestone, maintenance or fixed payment received by EPI Health in connection with any license or sublicense of the assets transferred in the disposition in any territory outside of the United States, subject to specified exceptions. On July 17, 2023, EPI Health filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code. Through the bankruptcy process, EPI Health and its parent company, Novan, Inc., sold the RHOFADE assets to a third party. Under the sale agreement, the Company’s asset purchase agreement with EPI Health was not assumed by the buyer, and as a result, the buyer is not obligated to continue to pay the Company royalties or milestones on future sales of RHOFADE, nor is the buyer obligated to cure the outstanding amounts in default by EPI Health. The sale was approved by the bankruptcy court on September 12, 2023. As a result of the bankruptcy proceedings, the Company recorded an allowance for doubtful accounts resulting in $0.3 million of bad debt expense for the three months ended September 30, 2023, and $1.3 million of bad debt expense for the nine months ended September 30, 2023, representing all amounts that were due and outstanding by EPI Health. Agreement and Plan of Merger – Confluence The Company entered into an Agreement and Plan of Merger, pursuant to which it acquired Confluence (the “Confluence Agreement”). Under the Confluence Agreement, the Company has agreed to pay the former Confluence equity holders aggregate remaining contingent consideration of up to $75.0 million based upon the achievement of specified regulatory and commercial milestones set forth in the Confluence Agreement. In addition, the Company has agreed to pay the former Confluence equity holders future royalty payments calculated as a low single-digit percentage of annual net sales, subject to specified reductions, limitations and other adjustments, until the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis or, in specified circumstances, ten years from the first commercial sale of such product. In addition to the payments described above, if the Company sells, licenses or transfers any of the intellectual property acquired from Confluence pursuant to the Confluence Agreement to a third party, the Company will be obligated to pay the former Confluence equity holders a portion of any consideration received from such sale, license or transfer in specified circumstances. As of September 30, 2023 and December 31, 2022, the balance of the Company’s contingent consideration liability was $32.5 million and $33.1 million, respectively (see Note 3). |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Taxes | |
Income Taxes | 12. Income Taxes The Company did not record a federal or state income tax benefit for losses incurred during the three and nine months ended September 30, 2023 and 2022. The Company concluded that it is more likely than not that its deferred tax assets will not be realized which resulted in recording a full valuation allowance during those periods. |
Segment Information
Segment Information | 9 Months Ended |
Sep. 30, 2023 | |
Segment Information | |
Segment Information | 13. Segment Information The Company has two reportable segments, therapeutics and contract research. The therapeutics segment is focused on identifying and developing innovative therapies to address significant unmet needs for immuno-inflammatory diseases. The contract research segment earns revenue from the provision of laboratory services. Contract research revenue is generally evidenced by contracts with clients which are on an agreed upon fixed-price, fee-for-service basis. Corporate and other includes general and administrative expenses as well as eliminations of intercompany transactions. The Company does not report balance sheet information by segment since it is not reviewed by the chief operating decision maker, and all of the Company’s tangible assets are held in the United States. The Company’s results of operations by segment for the three and nine months ended September 30, 2023 and 2022 are summarized in the tables below: (In thousands) Contract Corporate Total Three Months Ended September 30, 2023 Therapeutics Research and Other Company Total revenue $ 8,577 $ 4,817 $ (4,112) $ 9,282 Cost of revenue — 4,726 (3,878) 848 Research and development 24,110 — (234) 23,876 General and administrative — 1,174 5,917 7,091 Licensing 7,344 — — 7,344 Revaluation of contingent consideration 1,700 — — 1,700 Loss from operations $ (24,577) $ (1,083) $ (5,917) $ (31,577) (In thousands) Contract Corporate Total Three Months Ended September 30, 2022 Therapeutics Research and Other Company Total revenue $ 17,928 $ 4,299 $ (3,209) $ 19,018 Cost of revenue — 3,925 (3,002) 923 Research and development 23,863 — (207) 23,656 General and administrative — 875 4,938 5,813 Licensing 7,300 — — 7,300 Revaluation of contingent consideration 2,200 — — 2,200 Loss from operations $ (15,435) $ (501) $ (4,938) $ (20,874) (In thousands) Contract Corporate Total Nine Months Ended September 30, 2023 Therapeutics Research and Other Company Total revenue $ 11,210 $ 14,591 $ (12,122) $ 13,679 Cost of revenue — 14,068 (11,370) 2,698 Research and development 72,490 — (752) 71,738 General and administrative — 3,490 20,708 24,198 Licensing 8,955 — — 8,955 Revaluation of contingent consideration (600) — — (600) Loss from operations $ (69,635) $ (2,967) $ (20,708) $ (93,310) (In thousands) Contract Corporate Total Nine Months Ended September 30, 2022 Therapeutics Research and Other Company Total revenue $ 18,469 $ 12,795 $ (9,265) $ 21,999 Cost of revenue — 11,823 (8,677) 3,146 Research and development 57,329 — (588) 56,741 General and administrative — 2,570 15,417 17,987 Licensing 7,300 — — 7,300 Revaluation of contingent consideration (2,400) — — (2,400) Loss from operations $ (43,760) $ (1,598) $ (15,417) $ (60,775) Intersegment Revenue Revenue for the contract research segment included $4.1 million and $3.2 million for services performed on behalf of the therapeutics segment for the three months ended September 30, 2023 and 2022, respectively, and $12.1 million and $9.3 million for the nine months ended September 30, 2023 and 2022, respectively. All intersegment revenue has been eliminated in the Company’s condensed consolidated statement of operations. |
Legal Proceedings
Legal Proceedings | 9 Months Ended |
Sep. 30, 2023 | |
Legal Proceedings | |
Legal Proceedings | 14. Legal Proceedings Securities Class Action On July 30, 2019, plaintiff Linda Rosi (“Rosi”) filed a putative class action complaint captioned Rosi v. Aclaris Therapeutics, Inc., et al. Fulcher v. Aclaris Therapeutics, Inc., et al. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated statement of stockholders’ equity for the three and nine months ended September 30, 2023 and 2022, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements contained in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 23, 2023 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the Company’s financial position as of September 30, 2023, the results of its operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, its changes in stockholders’ equity for the three and nine months ended September 30, 2023 and 2022 and its cash flows for the nine months ended September 30, 2023 and 2022. The condensed consolidated balance sheet data as of December 31, 2022 was derived from audited financial statements but does not include all disclosures required by generally accepted accounting principles in the United States (“GAAP”). The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2023 and 2022 are unaudited. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. The unaudited interim financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 23, 2023. |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with GAAP. The condensed consolidated financial statements of the Company include the accounts of the operating parent company, Aclaris Therapeutics, Inc., and its wholly owned subsidiaries. All intercompany transactions have been eliminated. Based upon the Company’s revenue, the Company believes that gross profit does not provide a meaningful measure of profitability and, therefore, has not included a line item for gross profit on the condensed consolidated statement of operations. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, contingent consideration and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require an update to its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from the Company’s estimates. |
Reclassifications | Reclassifications Certain prior year amounts have been reclassified to conform to the current year’s financial statement presentation. |
Concentration of Credit Risk and of Significant Suppliers | Concentration of Credit Risk and of Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company holds all cash, cash equivalents and marketable securities balances at three accredited financial institutions, the majority of which are in amounts that exceed or are not subject to federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company is dependent on third-party manufacturers to supply drug product, including all underlying components, for its research and development activities, including preclinical and clinical testing. These activities could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients or other components. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 23, 2023. There have been no changes to the Company’s significant accounting policies from those disclosed in the annual report. |
Contingent Consideration | Contingent Consideration The Company initially recorded a contingent consideration liability at fair value on the date of acquisition related to future potential payments resulting from the acquisition of Confluence based upon significant unobservable inputs including the achievement of development, regulatory and commercial milestones, as well as estimated future sales levels and the discount rates applied to calculate the present value of the potential payments. Significant judgement was involved in determining the appropriateness of these assumptions. These assumptions are considered Level 3 inputs. Revaluation of the contingent consideration liability can result from changes to one or more of these assumptions. The Company evaluates the fair value estimate of the contingent consideration liability on a quarterly basis with changes, if any, recorded as income or expense in the condensed consolidated statement of operations. The fair value of contingent consideration is estimated using a probability-weighted expected payment model for regulatory milestone payments and a Monte Carlo simulation model for commercial milestone and royalty payments and then applying a risk-adjusted discount rate to calculate the present value of the potential payments. Significant assumptions used in the Company’s estimates include the probability of achieving regulatory milestones and commencing commercialization, which are based on an asset’s current stage of development and a review of existing clinical data. Probability of success on the year of each potential payment. |
Revenue Recognition | Revenue Recognition The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition in accordance with ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) performance obligations are satisfied. At contract inception, the Company assesses the goods or services promised within a contract with a customer to identify the performance obligations, and to determine if they are distinct. The Company recognizes the revenue that is allocated to each distinct performance obligation when (or as) that performance obligation is satisfied. The Company only recognizes revenue when collection of the consideration it is entitled to under a contract with a customer is probable. Contract Research Licensing Licenses of Intellectual Property Milestone and Royalty Payments The Company recognizes revenue from development, regulatory and anniversary milestone payments as they are achieved. The Company recognizes revenue from commercial milestones and royalty payments as the sales occur. |
Discontinued Operations | Discontinued Operations In September 2019, the Company announced the completion of a strategic review and its decision to refocus its resources on its immuno-inflammatory development programs and to actively seek partners for its commercial products. As of September 30, 2023 and December 31, 2022, the Company had $2.2 million in accrued expenses reported as discontinued operations in the Company’s consolidated balance sheet. |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value of Financial Assets and Liabilities | |
Schedule of assets and liabilities measured at fair value on a recurring basis | September 30, 2023 (In thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 35,593 $ — $ — $ 35,593 Marketable securities — 147,956 — 147,956 Total assets $ 35,593 $ 147,956 $ — $ 183,549 Liabilities: Contingent consideration $ — $ — $ 32,500 $ 32,500 Total liabilities $ — $ — $ 32,500 $ 32,500 December 31, 2022 (In thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 38,516 $ — $ — $ 38,516 Marketable securities — 184,536 — 184,536 Total assets $ 38,516 $ 184,536 $ — $ 223,052 Liabilities: Contingent consideration $ — $ — $ 33,100 $ 33,100 Total liabilities $ — $ — $ 33,100 $ 33,100 |
Schedule of the fair value of available for sale marketable securities | September 30, 2023 Gross Gross Book Unrealized Unrealized Fair (In thousands) Value Gain Loss Value Marketable securities: Corporate debt securities (1) $ 52,169 $ — $ (463) $ 51,706 Commercial paper 14,663 — (31) 14,632 Treasury bills 4,936 1 — 4,937 Asset-backed debt securities (2) 11,349 8 (21) 11,336 Foreign government agency debt securities (3) 4,659 — (18) 4,641 U.S. government and government agency debt securities (4) 61,315 — (611) 60,704 Total marketable securities $ 149,091 $ 9 $ (1,144) $ 147,956 (1) Included in Corporate debt securities is $27.5 million with maturity dates between one and two years . (2) Included in Asset-backed debt securities is $11.3 million with maturity dates between two and four years . (3) Included in Foreign government agency debt securities is $4.6 million with a maturity date between one and two years . (4) Included in U.S. government and government agency debt securities is $40.5 million with maturity dates between one and two years . December 31, 2022 Gross Gross Book Unrealized Unrealized Fair (In thousands) Value Gain Loss Value Marketable securities: Corporate debt securities (1) $ 40,626 $ — $ (251) $ 40,375 Commercial paper 79,598 — — 79,598 Asset-backed debt securities (2) 14,641 4 (123) 14,522 U.S. government and government agency debt securities (3) 50,571 — (530) 50,041 Total marketable securities $ 185,436 $ 4 $ (904) $ 184,536 (1) Included in Corporate debt securities is $4.8 million with maturity dates between one and five years . (2) Included in Asset-backed debt securities is $2.4 million with maturity dates between one and five years . (3) Included in U.S. government and government agency debt securities is $5.0 million with maturity dates between one and five years . |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property and Equipment, Net | |
Schedule of property and equipment, net | September 30, December 31, (In thousands) 2023 2022 Computer equipment $ 1,444 $ 1,381 Lab equipment 3,152 2,010 Furniture and fixtures 649 620 Leasehold improvements 1,123 1,123 Property and equipment, gross 6,368 5,134 Accumulated depreciation (4,604) (4,035) Property and equipment, net $ 1,764 $ 1,099 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Intangible Assets | |
Schedule of intangible assets | Gross Cost Accumulated Amortization Remaining September 30, December 31, September 30, December 31, (In thousands, except years) Life (years) 2023 2022 2023 2022 Other intangible assets 3.8 $ 751 $ 751 $ 463 $ 407 In-process research and development n/a 6,629 6,629 — — Total intangible assets $ 7,380 $ 7,380 $ 463 $ 407 |
Schedule of estimated future amortization expenses | Year Ending (In thousands) December 31, 2023 $ 19 2024 75 2025 75 2026 75 2027 44 Total $ 288 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Schedule of accrued expenses | September 30, December 31, (In thousands) 2023 2022 Employee compensation expenses $ 4,968 $ 5,295 Research and development expenses 2,985 2,689 Licensing expenses 6,647 500 Other 560 217 Total accrued expenses $ 15,160 $ 8,701 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Awards | |
Assumptions used to determine fair value of stock options granted | Nine Months Ended September 30, 2023 2022 Risk-free interest rate 3.53 % 2.07 % Expected term (in years) 6.2 6.2 Expected volatility 77.73 % 77.95 % Expected dividend yield 0 % 0 % |
Summary of stock option activity | Weighted Weighted Average Average Remaining Aggregate Number Exercise Contractual Intrinsic (In thousands, except share and per share data and years) of Shares Price Term Value (in years) Outstanding as of December 31, 2022 5,167,164 $ 16.04 7.2 $ 15,288 Granted 2,218,550 15.71 Exercised (34,269) 1.30 $ 319 Forfeited and cancelled (228,990) 15.71 Outstanding as of September 30, 2023 7,122,455 $ 16.02 7.1 $ 3,680 Options vested and expected to vest as of September 30, 2023 7,122,455 $ 16.02 7.1 $ 3,680 Options exercisable as of September 30, 2023 3,190,762 $ 16.70 4.7 $ 3,323 |
Summary of restricted stock units activity | Weighted Average Grant Date Aggregate Number Fair Value Intrinsic (In thousands, except share and per share data) of Shares Per Share Value Outstanding as of December 31, 2022 1,520,730 $ 14.02 Granted 980,700 15.32 Vested (706,167) 11.61 $ 8,141 Forfeited and cancelled (88,073) 15.68 Outstanding as of September 30, 2023 1,707,190 $ 15.68 |
Stock-based compensation expense | Three Months Ended Nine Months Ended September 30, September 30, (In thousands) 2023 2022 2023 2022 Cost of revenue $ 347 $ 307 $ 1,119 $ 837 Research and development 3,072 1,400 9,168 2,228 General and administrative 2,529 2,481 8,989 7,161 Total stock-based compensation expense $ 5,948 $ 4,188 $ 19,276 $ 10,226 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss per Share | |
Basic and diluted net loss per share | Three Months Ended Nine Months Ended September 30, September 30, (In thousands, except for share and per share data) 2023 2022 2023 2022 Numerator: Net loss $ (29,261) $ (19,952) $ (86,990) $ (59,273) Denominator: Weighted average shares of common stock outstanding, basic and diluted 70,807,934 66,675,337 69,452,495 64,718,008 Net loss per share, basic and diluted $ (0.41) $ (0.30) $ (1.25) $ (0.92) |
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | September 30, 2023 2022 Options to purchase common stock 7,122,455 5,187,664 Restricted stock unit awards 1,707,190 1,585,184 Total potential shares of common stock 8,829,645 6,772,848 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Schedule of supplemental balance sheet information related to operating leases | September 30, December 31, (In thousands) 2023 2022 Operating Leases: Gross cost $ 5,804 $ 5,240 Accumulated amortization (3,220) (2,560) Other assets $ 2,584 $ 2,680 Current portion of lease liabilities $ 310 $ 684 Other liabilities 1,834 1,570 Total operating lease liabilities $ 2,144 $ 2,254 |
Segment Information (Tables)
Segment Information (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Segment Information | |
Summary of results of operations by segment | (In thousands) Contract Corporate Total Three Months Ended September 30, 2023 Therapeutics Research and Other Company Total revenue $ 8,577 $ 4,817 $ (4,112) $ 9,282 Cost of revenue — 4,726 (3,878) 848 Research and development 24,110 — (234) 23,876 General and administrative — 1,174 5,917 7,091 Licensing 7,344 — — 7,344 Revaluation of contingent consideration 1,700 — — 1,700 Loss from operations $ (24,577) $ (1,083) $ (5,917) $ (31,577) (In thousands) Contract Corporate Total Three Months Ended September 30, 2022 Therapeutics Research and Other Company Total revenue $ 17,928 $ 4,299 $ (3,209) $ 19,018 Cost of revenue — 3,925 (3,002) 923 Research and development 23,863 — (207) 23,656 General and administrative — 875 4,938 5,813 Licensing 7,300 — — 7,300 Revaluation of contingent consideration 2,200 — — 2,200 Loss from operations $ (15,435) $ (501) $ (4,938) $ (20,874) (In thousands) Contract Corporate Total Nine Months Ended September 30, 2023 Therapeutics Research and Other Company Total revenue $ 11,210 $ 14,591 $ (12,122) $ 13,679 Cost of revenue — 14,068 (11,370) 2,698 Research and development 72,490 — (752) 71,738 General and administrative — 3,490 20,708 24,198 Licensing 8,955 — — 8,955 Revaluation of contingent consideration (600) — — (600) Loss from operations $ (69,635) $ (2,967) $ (20,708) $ (93,310) (In thousands) Contract Corporate Total Nine Months Ended September 30, 2022 Therapeutics Research and Other Company Total revenue $ 18,469 $ 12,795 $ (9,265) $ 21,999 Cost of revenue — 11,823 (8,677) 3,146 Research and development 57,329 — (588) 56,741 General and administrative — 2,570 15,417 17,987 Licensing 7,300 — — 7,300 Revaluation of contingent consideration (2,400) — — (2,400) Loss from operations $ (43,760) $ (1,598) $ (15,417) $ (60,775) |
Organization and Nature of Bu_2
Organization and Nature of Business (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Organization and Nature of Business | ||
Cash, cash equivalents and marketable securities | $ 187,000 | |
Accumulated deficit | $ 769,305 | $ 682,315 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ in Millions | 9 Months Ended | |
Sep. 30, 2023 USD ($) item | Dec. 31, 2022 USD ($) | |
Concentration of Credit Risk and of Significant Suppliers | ||
Number of financial institutions holding entity funds | item | 3 | |
Discontinued Operations. | ||
Accrued expenses | $ | $ 2.2 | $ 2.2 |
Minimum | ||
Contingent Consideration | ||
Probability of success assumptions | 17% | |
Discount range | 9.30% | |
Maximum | ||
Contingent Consideration | ||
Probability of success assumptions | 41% | |
Discount range | 10.40% |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Assets: | |||||
Marketable securities | $ 147,956 | $ 147,956 | $ 184,536 | ||
Liabilities: | |||||
Transfers into or out of Level 3 | 0 | $ 0 | 0 | $ 0 | |
Revaluation of contingent consideration | 1,700 | $ 2,200 | (600) | $ (2,400) | |
Confluence | |||||
Liabilities: | |||||
Revaluation of contingent consideration | (600) | ||||
Recurring | |||||
Assets: | |||||
Cash equivalents | 35,593 | 35,593 | 38,516 | ||
Marketable securities | 147,956 | 147,956 | 184,536 | ||
Total assets measured at fair value | 183,549 | 183,549 | 223,052 | ||
Liabilities: | |||||
Contingent consideration | 32,500 | 32,500 | 33,100 | ||
Total liabilities measured at fair value | 32,500 | 32,500 | 33,100 | ||
Recurring | Level 1 | |||||
Assets: | |||||
Cash equivalents | 35,593 | 35,593 | 38,516 | ||
Total assets measured at fair value | 35,593 | 35,593 | 38,516 | ||
Recurring | Level 2 | |||||
Assets: | |||||
Marketable securities | 147,956 | 147,956 | 184,536 | ||
Total assets measured at fair value | 147,956 | 147,956 | 184,536 | ||
Recurring | Level 3 | |||||
Liabilities: | |||||
Contingent consideration | 32,500 | 32,500 | 33,100 | ||
Total liabilities measured at fair value | $ 32,500 | $ 32,500 | $ 33,100 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - By Type of Security (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Marketable securities: | ||
Book Value | $ 149,091 | $ 185,436 |
Gross Unrealized Gain | 9 | 4 |
Gross Unrealized Loss | (1,144) | (904) |
Fair Value | 147,956 | 184,536 |
Corporate debt securities | ||
Marketable securities: | ||
Book Value | 52,169 | 40,626 |
Gross Unrealized Loss | (463) | (251) |
Fair Value | 51,706 | 40,375 |
Debt securities, maturity dates between one and five years | $ 27,500 | $ 4,800 |
Corporate debt securities | Minimum | ||
Marketable securities: | ||
Marketable securities maturity period | 1 year | 1 year |
Corporate debt securities | Maximum | ||
Marketable securities: | ||
Marketable securities maturity period | 2 years | 5 years |
Commercial paper | ||
Marketable securities: | ||
Book Value | $ 14,663 | $ 79,598 |
Gross Unrealized Loss | (31) | |
Fair Value | 14,632 | 79,598 |
Treasury bills | ||
Marketable securities: | ||
Book Value | 4,936 | |
Gross Unrealized Gain | 1 | |
Fair Value | 4,937 | |
Asset-backed securities | ||
Marketable securities: | ||
Book Value | 11,349 | 14,641 |
Gross Unrealized Gain | 8 | 4 |
Gross Unrealized Loss | (21) | (123) |
Fair Value | 11,336 | 14,522 |
Debt securities, maturity dates between one and five years | $ 11,300 | $ 2,400 |
Asset-backed securities | Minimum | ||
Marketable securities: | ||
Marketable securities maturity period | 2 years | 1 year |
Asset-backed securities | Maximum | ||
Marketable securities: | ||
Marketable securities maturity period | 4 years | 5 years |
Foreign government agency debt securities | ||
Marketable securities: | ||
Book Value | $ 4,659 | |
Gross Unrealized Loss | (18) | |
Fair Value | 4,641 | |
Debt securities, maturity dates between one and five years | $ 4,600 | |
Foreign government agency debt securities | Minimum | ||
Marketable securities: | ||
Marketable securities maturity period | 1 year | |
Foreign government agency debt securities | Maximum | ||
Marketable securities: | ||
Marketable securities maturity period | 2 years | |
U.S. government and agency debt securities | ||
Marketable securities: | ||
Book Value | $ 61,315 | $ 50,571 |
Gross Unrealized Loss | (611) | (530) |
Fair Value | 60,704 | 50,041 |
Debt securities, maturity dates between one and five years | $ 40,500 | $ 5,000 |
U.S. government and agency debt securities | Minimum | ||
Marketable securities: | ||
Marketable securities maturity period | 1 year | 1 year |
U.S. government and agency debt securities | Maximum | ||
Marketable securities: | ||
Marketable securities maturity period | 2 years | 5 years |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Property and Equipment, Net | |||||
Property and equipment, gross | $ 6,368 | $ 6,368 | $ 5,134 | ||
Accumulated depreciation | (4,604) | (4,604) | (4,035) | ||
Property and equipment, net | 1,764 | 1,764 | 1,099 | ||
Depreciation expense | 200 | $ 200 | 600 | $ 600 | |
Computer equipment | |||||
Property and Equipment, Net | |||||
Property and equipment, gross | 1,444 | 1,444 | 1,381 | ||
Lab equipment | |||||
Property and Equipment, Net | |||||
Property and equipment, gross | 3,152 | 3,152 | 2,010 | ||
Furniture and fixtures | |||||
Property and Equipment, Net | |||||
Property and equipment, gross | 649 | 649 | 620 | ||
Leasehold improvements | |||||
Property and Equipment, Net | |||||
Property and equipment, gross | $ 1,123 | $ 1,123 | $ 1,123 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Definite-lived intangible assets | ||
Accumulated Amortization | $ 463 | $ 407 |
Intangible assets, net | ||
Gross cost | 7,380 | 7,380 |
In-process research and development | ||
Indefinite-lived intangible assets | ||
Gross Cost | $ 6,629 | 6,629 |
Other intangible assets | ||
Intangible Assets | ||
Remaining Life (years) | 3 years 9 months 18 days | |
Definite-lived intangible assets | ||
Gross Cost | $ 751 | 751 |
Accumulated Amortization | $ 463 | $ 407 |
Intangible Assets - Future Amor
Intangible Assets - Future Amortization Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||||
Amortization expense | $ 19 | $ 19 | $ 56 | $ 56 |
Future amortization expenses | ||||
2023 | 19 | 19 | ||
2024 | 75 | 75 | ||
2025 | 75 | 75 | ||
2026 | 75 | 75 | ||
2027 | 44 | 44 | ||
Total | $ 288 | $ 288 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses | ||
Employee compensation expenses | $ 4,968 | $ 5,295 |
Research and development expenses | 2,985 | 2,689 |
Licensing expenses | 6,647 | 500 |
Other | 560 | 217 |
Total accrued expenses | $ 15,160 | $ 8,701 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | |||
Sep. 30, 2023 USD ($) Vote $ / shares shares | Jun. 01, 2023 shares | May 31, 2023 shares | Dec. 31, 2022 $ / shares shares | |
Stockholders' Equity | ||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||
Preferred stock, shares outstanding | 0 | 0 | ||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 100,000,000 | 100,000,000 |
Common stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 | ||
Common stock, shares issued | 70,818,954 | 66,688,647 | ||
Common stock, shares outstanding | 70,818,954 | 66,688,647 | ||
Number of votes per share | Vote | 1 | |||
Dividends declared | $ | $ 0 |
Stockholders' Equity - Other Of
Stockholders' Equity - Other Offerings and ATM Facility (Details) - At The Market Offering - Silicon Valley Bank Securities LLC and Cantor Fitzgerald & Co. - USD ($) shares in Millions, $ in Millions | 1 Months Ended | |
Apr. 30, 2023 | Apr. 30, 2022 | |
Subsidiary, Sale of Stock [Line Items] | ||
Common stock, sold | 3.4 | 4.8 |
Aggregate gross proceeds | $ 27.5 | $ 75 |
Payments of stock offering costs | $ 0.8 | $ 2.3 |
Stock-Based Awards (Details)
Stock-Based Awards (Details) - shares | 9 Months Ended | ||||
Jan. 01, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Sep. 30, 2015 | |
Stock-based awards | |||||
Options outstanding | 7,122,455 | 5,167,164 | |||
Stock Option Valuation | |||||
Risk-free interest rate (as a percent) | 3.53% | 2.07% | |||
Expected term (in years) | 6 years 2 months 12 days | 6 years 2 months 12 days | |||
Expected volatility (as a percent) | 77.73% | 77.95% | |||
Expected dividend yield (as a percent) | 0% | 0% | |||
2017 Inducement Plan | |||||
Stock-based awards | |||||
Options outstanding | 370,600 | ||||
2015 Equity Incentive Plan | |||||
Stock-based awards | |||||
Number of shares authorized | 1,643,872 | ||||
Number of shares available for grant | 2,890,919 | ||||
Percentage increase to shares available for grant from common outstanding as of preceding December 31 (as a percent) | 4% | ||||
Additional shares available | 2,667,545 | ||||
Options outstanding | 6,295,647 | ||||
2015 Equity Incentive Plan | Restricted stock unit awards | |||||
Stock-based awards | |||||
Number of shares outstanding | 1,707,190 | ||||
2012 Equity Compensation Plan | |||||
Stock-based awards | |||||
Number of shares available for grant | 0 | ||||
Options outstanding | 456,208 |
Stock-Based Awards - Option Act
Stock-Based Awards - Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Options, Number of Shares | ||
Number of Shares, beginning balance | 5,167,164 | |
Number of Shares, Granted | 2,218,550 | |
Number of Shares, Exercised | (34,269) | |
Number of Shares, Forfeited and cancelled | (228,990) | |
Number of Shares, ending balance | 7,122,455 | 5,167,164 |
Number of Shares, Options vested and expected to vest | 7,122,455 | |
Number of Shares, Options exercisable | 3,190,762 | |
Options, Weighted Average Exercise Price | ||
Weighted Average Exercise Price, beginning balance (in dollars per share) | $ 16.04 | |
Weighted Average Exercise Price, Granted (in dollars per share) | 15.71 | |
Weighted Average Exercise Price, Exercised (in dollars per share) | 1.30 | |
Weighted Average Exercise Price, Forfeited and cancelled (in dollars per share) | 15.71 | |
Weighted Average Exercise Price, ending balance (in dollars per share) | 16.02 | $ 16.04 |
Weighted Average Exercise Price, Options vested and expected to vest (in dollars per share) | 16.02 | |
Weighted Average Exercise Price, Options exercisable (in dollars per share) | $ 16.70 | |
Options, Weighted Average Remaining Contractual Term | ||
Weighted Average Remaining Contractual Term (in years) | 7 years 1 month 6 days | 7 years 2 months 12 days |
Weighted Average Remaining Contractual Term, Options vested and expected to vest (in years) | 7 years 1 month 6 days | |
Weighted Average Remaining Contractual Term, Options exercisable (in years) | 4 years 8 months 12 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value | $ 3,680 | $ 15,288 |
Aggregate Intrinsic Value, Exercised | 319 | |
Aggregate Intrinsic Value, Options vested and expected to vest | 3,680 | |
Aggregate Intrinsic Value, Options exercisable | $ 3,323 | |
Weighted average grant-date fair value of stock options granted (in dollars per share) | $ 11.04 |
Stock-Based Awards - RSUs (Deta
Stock-Based Awards - RSUs (Details) - Restricted stock unit awards $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
RSU, Number of Units | |
Units outstanding, beginning of the year | shares | 1,520,730 |
Granted | shares | 980,700 |
Vested | shares | (706,167) |
Forfeited and cancelled | shares | (88,073) |
Units outstanding, end of the year | shares | 1,707,190 |
RSU, Weighted Average Grant Date Fair Value Per Unit | |
Weighted average grant date fair value, beginning balance (in dollars per share) | $ / shares | $ 14.02 |
Weighted average grant date fair value, granted (in dollars per share) | $ / shares | 15.32 |
Weighted average grant date fair value, vested (in dollars per share) | $ / shares | 11.61 |
Weighted average grant date fair value, forfeited and cancelled (in dollars per share) | $ / shares | 15.68 |
Weighted average grant date fair value, ending balance (in dollars per share) | $ / shares | $ 15.68 |
Aggregate intrinsic value of awards that vested during the period | $ | $ 8,141 |
Stock-Based Awards - Compensati
Stock-Based Awards - Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 5,948 | $ 4,188 | $ 19,276 | $ 10,226 |
Unrecognized stock-based compensation expense, options | 35,600 | 35,600 | ||
Unrecognized stock-based compensation expense, RSUs | 21,700 | 21,700 | ||
Cost of revenue | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 347 | 307 | 1,119 | 837 |
Research and development | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 3,072 | 1,400 | 9,168 | 2,228 |
General and administrative | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 2,529 | $ 2,481 | $ 8,989 | $ 7,161 |
Options to purchase common stock | ||||
Stock-based compensation expense | ||||
Weighted average recognition period unrecognized stock-based compensation cost (in years) | 3 years 1 month 6 days | |||
Restricted stock unit awards | ||||
Stock-based compensation expense | ||||
Weighted average recognition period unrecognized stock-based compensation cost (in years) | 2 years 9 months 18 days |
Net Loss per Share (Details)
Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator: | ||||||||
Net loss | $ (29,261) | $ (29,569) | $ (28,160) | $ (19,952) | $ (20,532) | $ (18,789) | $ (86,990) | $ (59,273) |
Denominator: | ||||||||
Weighted average shares of common stock outstanding, basic | 70,807,934 | 66,675,337 | 69,452,495 | 64,718,008 | ||||
Weighted average shares of common stock outstanding, diluted | 70,807,934 | 66,675,337 | 69,452,495 | 64,718,008 | ||||
Net loss per share, basic | $ (0.41) | $ (0.30) | $ (1.25) | $ (0.92) | ||||
Net loss per share, diluted | $ (0.41) | $ (0.30) | $ (1.25) | $ (0.92) |
Net Loss per Share - Anti-dilut
Net Loss per Share - Anti-dilution (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 8,829,645 | 6,772,848 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 7,122,455 | 5,187,664 |
Restricted stock unit awards | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 1,707,190 | 1,585,184 |
Leases (Details)
Leases (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Dec. 31, 2020 ft² | Sep. 30, 2023 USD ($) ft² | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) ft² | Sep. 30, 2022 USD ($) | May 31, 2023 ft² | Jan. 31, 2023 ft² | Dec. 31, 2022 USD ($) | Feb. 28, 2019 ft² | |
Leases | |||||||||
Area leased, sublease agreement | ft² | 33,019 | 33,019 | 11,564 | 20,433 | |||||
Sub-subleased | ft² | 8,115 | ||||||||
Additional sublease | ft² | 6,261 | ||||||||
Amortization expense | $ 200 | $ 300 | $ 700 | $ 800 | |||||
Operating Leases: | |||||||||
Accumulated amortization | (463) | (463) | $ (407) | ||||||
Other assets | 6,917 | 6,917 | 6,973 | ||||||
Current portion of lease liabilities | 310 | 310 | 684 | ||||||
Other liabilities | $ 1,834 | $ 1,834 | $ 1,570 | ||||||
Financial position | Other liabilities | Other liabilities | Other liabilities | ||||||
Total operating lease liabilities | $ 2,144 | $ 2,144 | $ 2,254 | ||||||
Operating Leases | |||||||||
Operating Leases: | |||||||||
Gross cost | 5,804 | 5,804 | 5,240 | ||||||
Accumulated amortization | (3,220) | (3,220) | (2,560) | ||||||
Other assets | $ 2,584 | $ 2,584 | $ 2,680 |
Agreements Related to Intelle_2
Agreements Related to Intellectual Property (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Oct. 31, 2019 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Agreements Related to Intellectual Property | ||||||
Payment licensing to third parties | $ 7,344 | $ 7,300 | $ 8,955 | $ 7,300 | ||
Revenue | 9,282 | 19,018 | 13,679 | 21,999 | ||
Contingent consideration | 32,500 | 32,500 | $ 33,100 | |||
Licensing | ||||||
Agreements Related to Intellectual Property | ||||||
Revenue | 8,577 | 17,898 | $ 11,210 | 18,378 | ||
Agreement and Plan of Merger | ||||||
Agreements Related to Intellectual Property | ||||||
Term of agreement | 10 years | |||||
Additional contingent consideration based on milestones, maximum, per Agreement | 75,000 | $ 75,000 | ||||
Patent License Agreement | Eli Lilly and Company | ||||||
Agreements Related to Intellectual Property | ||||||
Payment licensing to third parties | 7,300 | 7,300 | 9,000 | 7,300 | ||
Patent License Agreement | Eli Lilly and Company | Licensing | ||||||
Agreements Related to Intellectual Property | ||||||
Revenue | 8,300 | $ 17,600 | 10,700 | $ 17,600 | ||
APA | ||||||
Agreements Related to Intellectual Property | ||||||
Term of agreement | 10 years | |||||
Potential milestone payments | 20,000 | 20,000 | ||||
Percentage of upfront and license fees | 25% | |||||
Bad debt expenses | $ 300 | $ 1,300 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Taxes | ||||
Federal income tax benefit | $ 0 | $ 0 | $ 0 | $ 0 |
State income tax benefit | $ 0 | $ 0 | $ 0 | $ 0 |
Segment Information (Details)
Segment Information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | |
Segment Reporting Information [Line Items] | ||||
Number of reportable segments | segment | 2 | |||
Total revenue | $ 9,282 | $ 19,018 | $ 13,679 | $ 21,999 |
Cost of revenue | 848 | 923 | 2,698 | 3,146 |
Research and development | 23,876 | 23,656 | 71,738 | 56,741 |
General and administrative | 7,091 | 5,813 | 24,198 | 17,987 |
Licensing | 7,344 | 7,300 | 8,955 | 7,300 |
Revaluation of contingent consideration | 1,700 | 2,200 | (600) | (2,400) |
Loss from operations | (31,577) | (20,874) | (93,310) | (60,775) |
Operating Segments | Dermatology Therapeutics Segment | ||||
Segment Reporting Information [Line Items] | ||||
Total revenue | 8,577 | 17,928 | 11,210 | 18,469 |
Research and development | 24,110 | 23,863 | 72,490 | 57,329 |
Licensing | 7,344 | 7,300 | 8,955 | 7,300 |
Revaluation of contingent consideration | 1,700 | 2,200 | (600) | (2,400) |
Loss from operations | (24,577) | (15,435) | (69,635) | (43,760) |
Operating Segments | Contract Research Segment | ||||
Segment Reporting Information [Line Items] | ||||
Total revenue | 4,817 | 4,299 | 14,591 | 12,795 |
Cost of revenue | 4,726 | 3,925 | 14,068 | 11,823 |
General and administrative | 1,174 | 875 | 3,490 | 2,570 |
Loss from operations | (1,083) | (501) | (2,967) | (1,598) |
Corporate and Other | ||||
Segment Reporting Information [Line Items] | ||||
Total revenue | (4,112) | (3,209) | (12,122) | (9,265) |
Cost of revenue | (3,878) | (3,002) | (11,370) | (8,677) |
Research and development | (234) | (207) | (752) | (588) |
General and administrative | 5,917 | 4,938 | 20,708 | 15,417 |
Loss from operations | (5,917) | (4,938) | (20,708) | (15,417) |
Intersegment Eliminations | Contract Research Segment | ||||
Segment Reporting Information [Line Items] | ||||
Total revenue | $ 4,100 | $ 3,200 | $ 12,100 | $ 9,300 |
Legal Proceedings (Details)
Legal Proceedings (Details) $ in Millions | Dec. 31, 2021 USD ($) |
Consolidated Securities Action | |
Other Commitments [Line Items] | |
Accrual for estimated financial obligation | $ 2.7 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||||||
Net Income (Loss) | $ (29,261) | $ (29,569) | $ (28,160) | $ (19,952) | $ (20,532) | $ (18,789) | $ (86,990) | $ (59,273) |
Insider Trading Arrangements
Insider Trading Arrangements - Maxine Gowen | 3 Months Ended |
Sep. 30, 2023 shares | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | On August 17, 2023 , Maxine Gowen , a member of our Board of Directors , adopted a Rule 10b5-1 trading plan intended to satisfy the affirmative defense conditions of Rule10b5-1(c)(1) under the Exchange Act. Sales may commence under the plan on November 16, 2023 and the plan terminates on December 31, 2024 , subject to earlier termination in accordance with its terms. The aggregate number of securities to be sold under the plan is 44,801 shares of common stock. |
Name | Maxine Gowen |
Title | member of our Board of Directors |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | August 17, 2023 |
Termination Date | December 31, 2024 |
Aggregate Available | 44,801 |