Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 16, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | IMPL | ||
Entity Registrant Name | IMPEL NEUROPHARMA, INC. | ||
Entity Central Index Key | 0001445499 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Entity File Number | 001-40353 | ||
Entity Tax Identification Number | 26-3058238 | ||
Entity Address, Address Line One | 201 Elliott Avenue West | ||
Entity Address, Address Line Two | Suite 260 | ||
Entity Address, City or Town | Seattle | ||
Entity Address, State or Province | WA | ||
Entity Address, Postal Zip Code | 98119 | ||
City Area Code | 206 | ||
Entity Public Float | $ 39.1 | ||
Local Phone Number | 568-1466 | ||
Entity Common Stock, Shares Outstanding | 23,148,150 | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Entity Incorporation, State or Country Code | DE | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
ICFR Auditor Attestation Flag | false | ||
Documents Incorporated by Reference [Text Block] | DOCUMENTS INCORPORATED BY REFERENCE | ||
Auditor Firm ID | 42 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Seattle, Washington |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 88,212 | $ 7,095 |
Trade receivable, net | 1,352 | |
Inventory | 2,824 | 0 |
Prepaid expenses and other current assets | 2,188 | 1,077 |
Total current assets | 94,576 | 8,172 |
Property and equipment, net | 3,149 | 3,700 |
Other assets | 187 | 187 |
Total assets | 97,912 | 12,059 |
Current liabilities: | ||
Accounts payable | 6,367 | 4,314 |
Accrued liabilities | 8,950 | 3,173 |
Current portion of term debt | 417 | |
Common stock warrant liabilities | 637 | |
Redeemable convertible preferred stock warrant liabilities | 2,622 | |
Total current liabilities | 15,954 | 10,526 |
Long-term debt | 29,450 | 7,994 |
Total liabilities | 45,404 | 18,520 |
Commitments and contingencies (Note 5) | ||
Redeemable convertible preferred stock, $0.001 par value, and 204,198,489 shares authorized at September 30, 2021 and December 31, 2020 respectively, and 202,009,981 shares issued and outstanding at September 30, 2021 and December 31, 2020 respectively, aggregate liquidation preference of $128,922 at December 31, 2020 | 127,039 | |
Stockholders' equity (deficit): | ||
Preferred stock, $0.001 par value; 10,000,000 and shares authorized at September 30, 2021 and December 31, 2020, respectively | ||
Common stock, $0.001 par value; 300,000,000 and 266,833,885 shares authorized at September 30, 2021 and December 31, 2020, respectively; 23,037,298 and 755,478 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 23 | |
Additional paid-in capital | 267,283 | 4,762 |
Accumulated deficit | (214,798) | (138,262) |
Total stockholders' equity (deficit) | 52,508 | (133,500) |
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ 97,912 | $ 12,059 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Redeemable convertible preferred stock, par value | $ 0.001 | |
Redeemable convertible preferred stock, shares authorized | 204,198,489 | |
Redeemable convertible preferred stock, shares issued | 202,009,981 | |
Redeemable convertible preferred stock, shares outstanding | 202,009,981 | |
Redeemable convertible preferred stock, liquidation preference value | $ 128,922 | |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 266,833,885 |
Common stock, shares issued | 23,123,062 | 755,478 |
Common stock, shares outstanding | 23,123,062 | 755,478 |
Consolidated Statement of Opera
Consolidated Statement of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
Product revenue, net | $ 668 | |
Cost of goods sold | 691 | |
Gross profit | (23) | |
Operating expenses: | ||
Research and development | 20,563 | 28,298 |
Selling, general and administrative | 50,900 | 17,036 |
Total operating expenses | 71,463 | 45,334 |
Loss from operations | (71,486) | (45,334) |
Other (expense) income, net | (5,048) | (463) |
Loss before income taxes | (76,534) | (45,797) |
Provision for income taxes | 2 | 1 |
Net loss and comprehensive loss | (76,536) | (45,798) |
Accretion on redeemable convertible preferred stock | (129) | (518) |
Net loss attributable to common stockholders | $ (76,665) | $ (46,316) |
Net loss per share attributable to common stockholders, basic and diluted | $ (5.25) | $ (91.05) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 14,600,346 | 508,668 |
Consolidated Statement of Chang
Consolidated Statement of Changes in Redeemable Convertible Preferred Stock and Stockholders Deficit - USD ($) | Total | Initial public offering | follow-on public offering | Redeemable Convertible Preferred Stock [Member] | Redeemable Convertible Preferred Stock [Member]Initial public offering | Redeemable Convertible Preferred Series B Stock [Member] | Common Stock | Common StockInitial public offering | Common Stockfollow-on public offering | Additional Paid-In Capital | Additional Paid-In CapitalInitial public offering | Additional Paid-In Capitalfollow-on public offering | Accumulated Deficit |
Beginning Balance at Dec. 31, 2019 | $ 125,647,000 | ||||||||||||
Beginning Balance, Shares at Dec. 31, 2019 | 201,335,862 | ||||||||||||
Beginning Balance at Dec. 31, 2019 | $ (91,704,000) | $ 760,000 | $ (92,464,000) | ||||||||||
Beginning Balance, Shares at Dec. 31, 2019 | 360,115 | ||||||||||||
Accretion to redemption value on redeemable convertible preferred stock | (518,000) | $ 518,000 | (518,000) | ||||||||||
Conversion of convertible notes into common stock upon initial public offering | |||||||||||||
Issuance of redeemable convertible preferred stock upon the exercise of preferred warrants | $ 271,000 | $ 603,000 | |||||||||||
Issuance of redeemable convertible preferred stock upon the exercise of preferred warrants (in shares) | 296,008 | 378,111 | |||||||||||
Stock-based compensation expense | 3,641,000 | 3,641,000 | |||||||||||
Issuance of common stock upon the exercise of stock options | 879,000 | 879,000 | |||||||||||
Issuance of common stock upon the exercise of stock options, Shares | 395,363 | ||||||||||||
Net loss and comprehensive loss | (45,798,000) | (45,798,000) | |||||||||||
Ending Balance at Dec. 31, 2020 | $ 127,039,000 | $ 127,039,000 | |||||||||||
Ending Balance, Shares at Dec. 31, 2020 | 202,009,981 | 202,009,981 | |||||||||||
Ending Balance at Dec. 31, 2020 | $ (133,500,000) | 4,762,000 | (138,262,000) | ||||||||||
Ending Balance, Shares at Dec. 31, 2020 | 755,478 | ||||||||||||
Accretion to redemption value on redeemable convertible preferred stock | (129,000) | $ 129,000 | (129,000) | ||||||||||
Proceeds from initial public offering, net of underwriters' discounts and commissions | $ 71,997,000 | $ 48,316,000 | $ 5,000 | $ 4,000 | $ 71,992,000 | $ 48,312,000 | |||||||
Proceeds from initial public offering, net of underwriters' discounts and commissions, Shares | 5,333,334 | 3,450,000 | |||||||||||
Issuance of common stock upon exercise of warrants for cash | 377,000 | 377,000 | |||||||||||
Issuance of common stock upon exercise of warrants for cash (in shares) | 23,887 | ||||||||||||
Issuance of common stock upon net exercise of warrants upon initial public offering | 734,000 | 734,000 | |||||||||||
Issuance of common stock upon net exercise of warrants upon initial public offering (in shares) | 37,628 | ||||||||||||
Issuance of common stock upon exchange of Avenue warrant | 1,763,000 | 1,763,000 | |||||||||||
Issuance of common stock upon exchange of Avenue warrant (in shares) | 107,663 | ||||||||||||
Conversion of redeemable convertible preferred stock to common stock upon initial public offering | 127,168,000 | $ (127,168,000) | $ 13,000 | 127,155,000 | |||||||||
Conversion of redeemable convertible preferred stock to common stock upon initial public offering, Shares | (202,009,981) | 12,605,800 | |||||||||||
Conversion Of Convertible Notes Amount Converted At Initial Public Offering | 8,393,000 | $ 1,000 | 8,392,000 | ||||||||||
Conversion of convertible notes into common stock upon initial public offering | 8,393,000 | $ 559,585,000 | |||||||||||
Stock-based compensation expense | 3,130,000 | 3,130,000 | |||||||||||
Issuance of common stock upon the exercise of stock options | $ 795,000 | 795,000 | |||||||||||
Issuance of common stock upon the exercise of stock options, Shares | 249,687 | 249,687 | |||||||||||
Net loss and comprehensive loss | $ (76,536,000) | (76,536,000) | |||||||||||
Ending Balance at Dec. 31, 2021 | |||||||||||||
Ending Balance at Dec. 31, 2021 | $ 52,508,000 | $ 23,000 | $ 267,283,000 | $ (214,798,000) | |||||||||
Ending Balance, Shares at Dec. 31, 2021 | 23,123,062 |
Consolidated Statement of Cha_2
Consolidated Statement of Changes in Redeemable Convertible Preferred Stock and Stockholders Deficit (Parenthetical) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Initial public offering | |
Stock Issuance Cost | $ 2.4 |
Net Underwiters Discount And Commission | 5.6 |
follow-on public offering | |
Stock Issuance Cost | 0.6 |
Net Underwiters Discount And Commission | $ 2.8 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (76,536) | $ (45,798) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,088 | 1,077 |
Stock-based compensation | 3,130 | 3,641 |
Change in fair value of warrant liabilities | (59) | 153 |
Change in fair value of convertible notes | 839 | |
Loss on early extinguishment of debt | 1,993 | |
Write-down of inventory to net realizable value | 199 | |
Amortization of debt discount | 714 | 208 |
Noncash interest | 54 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,352) | |
Inventory | (3,023) | |
Prepaid expenses and other current assets | (1,111) | 1,447 |
Other assets | (187) | |
Accounts payable | 1,999 | 1,498 |
Accrued liabilities | 5,701 | (1,222) |
Net cash used in operating activities | (66,364) | (39,183) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (408) | (1,782) |
Net cash used in investing activities | (408) | (1,782) |
Cash flows from financing activities: | ||
Proceeds from initial public offering, net of issuance costs | 71,997 | |
Proceeds from follow-on public offering, net of issuance costs | 48,316 | |
Proceeds from issuance of long-term debt | 19,083 | 9,701 |
Proceeds from issuance of convertible notes | 7,500 | |
Proceeds from exercise of redeemable convertible preferred stock warrants | 197 | 479 |
Proceeds from issuance of common stock upon exercise of stock options | 796 | 879 |
Proceeds from Paycheck Protection Program | 1,100 | |
Repayment of Paycheck Protection Program | (1,100) | |
Net cash provided by financing activities | 147,889 | 11,059 |
Net increase (decrease) in cash | 81,117 | (29,906) |
Cash — Beginning of period | 7,095 | 37,001 |
Cash — End of period | 88,212 | 7,095 |
Supplemental disclosures of cash flow information: | ||
Accretion to redemption value on redeemable convertible preferred stock | 129 | |
Conversion of redeemable convertible preferred stock upon initial public offering | 127,168 | |
Issuance of common stock upon exchange / exercise of redeemable convertible preferred stock warrants upon initial public offering | 2,677 | |
Conversion of convertible notes into common stock upon initial public offering | 8,393 | |
Recognition of fair value of warrant liabilities issued in connection with issuance of debt | 751 | 1,498 |
Reclass of redeemable convertible preferred stock warrant liability to redeemable convertible preferred stock upon exercise of the warrants | 395 | |
Purchase of property and equipment included in accounts payable and accrued liabilities | 130 | 369 |
Cash paid for interest | $ 1,357 | $ 134 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business Impel Neuropharma, Inc. (“the Company”, "we", and "our"), is a late-stage pharmaceutical company focused on the development and commercialization of transformative therapies for patients suffering from diseases with high unmet medical needs, with an initial focus on diseases of the central nervous system, or CNS. The Company's lead product, Trudhesa (dihydroergotamine mesylate) Nasal Spray was approved by the U.S. Food and Drug Administration ("FDA") on September 2, 2021. Using the Company’s proprietary Precision Olfactory Delivery (POD®) technology, Trudhesa gently delivers dihydroergotamine mesylate (DHE), a proven, well-established therapeutic, quickly to the bloodstream through the vascular-rich upper nasal space. The Company’s strategy is to pair its POD®, upper nasal delivery technology with well-understood therapeutics or other therapeutics where rapid vascular absorption is preferred to drive therapeutic benefit, improve patient outcomes, reduce drug development risk and expand the commercial opportunity within its target diseases. The Company was incorporated under the laws of the State of Delaware on July 24, 2008 , maintains its headquarters and principal operations in Seattle, Washington, and performs certain of its research and development activities in Australia. Initial Public Offering On April 22, 2021, the Company’s Registration Statement on Form S-1 relating to its initial public offering, or IPO, was declared effective by the Securities and Exchange Commission, or the SEC, and the shares of its common stock began trading on the Nasdaq Global Select Market on April 23, 2021. The IPO closed on April 27, 2021, pursuant to which the Company issued and sold 5,333,334 shares of its common stock at a public offering price of $ 15.00 per share. The Company received net proceeds of approximately $ 72.0 million from the IPO, after deducting underwriting discounts and commissions of $ 5.6 million and offering costs of $ 2.4 million. Prior to the completion of the IPO, all shares of redeemable convertible preferred stock then outstanding were converted into 12,605,800 shares of common stock. In addition, the warrant held by Avenue Venture Opportunities Fund, L.P., or Avenue, was exchanged for 107,663 shares of common stock and warrants to purchase 1,987,348 shares of redeemable convertible preferred stock were cash exercised or automatically net exercised into an aggregate of 61,515 shares of common stock. The convertible notes issued in March 2021 for an aggregate principal amount of $ 7.5 million (see Note 6) were also converted into 559,585 shares of common stock at a 10 % discount of the IPO price. Follow-on Public Offering In September 2021, the Company completed a follow-on public offering of its common stock, pursuant to which the Company issued and sold 3,450,000 shares of its common stock ( which included 450,000 shares that were offered and sold pursuant to the full exercise of the underwriters’ option to purchase additional shares) at a public offering price of $ 15.00 per share. Including the option exercise, the Company received net proceeds of approximately $ 48.3 million after deducting underwriting discounts and commissions of $ 2.8 million and offering costs of $ 0.6 million. Reverse Stock Split In April 2021, the Company’s board of directors and stockholders approved an amendment to the Company’s certificate of incorporation to effect a reverse split of shares of the Company’s common stock on an one-for-16.37332 basis, which was effected on April 16, 2021 (the “Reverse Stock Split”). The number of authorized shares and the par values of the common stock and redeemable convertible preferred stock were not adjusted as a result of the Reverse Stock Split. In connection with the Reverse Stock Split, the conversion ratio for the Company’s outstanding redeemable convertible preferred stock was proportionately adjusted such that the common stock issuable upon conversion of such preferred stock was decreased in proportion to the Reverse Stock Split. All references to common stock and options to purchase common stock share data, per share data and related information contained in the consolidated financial statements have been retroactively adjusted to reflect the effect of the Reverse Stock Split for all periods presented. Liquidity and Capital Resources From the Company’s inception through December 31, 2021, it raised an aggregate of $ 292.8 million in proceeds from the IPO, follow-on public offering, sale and issuance of redeemable convertible preferred stock, convertible notes, debt and warrants. The Company had a cash and cash equivalents balance of $ 88.2 million as of December 31, 2021. Based upon the Company’s current operating plan, it estimates that its cash and cash equivalents as of December 31, 2021, along with proceeds from the Revenue Interest Financing Agreement and borrowings under the Oaktree Loan and Security Agreement (see note 14), are together sufficient for the Company to fund operating, investing, and financing cash flow needs for at least one year from the issuance date of these financial statements. The Company may be required to raise additional capital to meet working capital needs associated with commercialization and research and development activities. If sufficient funds on acceptable terms are not available when needed, the Company could be required to reduce operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs or planned product launch plans. Failure to manage discretionary spending or raise additional financing, as needed, may adversely impact the Company’s ability to achieve its intended business objectives. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying financial statements do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Consolidation The accompanying audited consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP. The consolidated financial statements include the operations of Impel Neuropharma, Inc., and its wholly owned Australian subsidiary. All intercompany balances and transactions have been eliminated upon consolidation. Reclassifications We have reclassified prior period financial statements to conform to the current period presentation. We reclassified certain amounts previously recorded as general and administrative expense to res earch and development expense. The reclassification had no impact on total operating costs, loss from operations, net loss, stockholders’ equity (deficit) or cash flows. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, management evaluates such estimates and assumptions for continued reasonableness. In particular, management makes estimates with respect to revenue recognition, inventory valuation, the fair values of common stock (prior to the Company's IPO), common stock and redeemable convertible preferred stock warrant liabilities, stock-based compensation expense, convertible debt and income taxes. Appropriate adjustments, if any, to the estimates used are made prospectively based upon such periodic evaluation. Actual results could differ from those estimates. Segments The Company’s chief operating decision maker is its Chief Executive Officer. The Chief Executive Officer reviews financial information on an aggregate basis for the purposes of evaluating financial performance and allocating the Company’s resources. Accordingly, the Company has determined that it operates in one segment. Substantially all of the Company’s assets are located in the U.S. Cash The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be cash equivalents. At December 31, 2021 and 2020, cash consisted of cash in bank deposits held at financial institutions. Accounts Receivable, net The Company’s trade accounts receivable consists of amounts due from specialty pharmacies and specialty distributors in the U.S. net of distribution service fees, prompt pay discounts and other adjustments. The Company's contracts with customers have standard payment terms that generally require payment within 45 days . The Company analyzes accounts that are past due for collectability, and periodically evaluates the creditworthiness of its customers. As of December 31, 2021, we determined an allowance for doubtful accounts was not req uired based upon our review of contractual payment terms and individual customer circumstances. The Company had no accounts receivable related to product sales in 2020. Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. Product Revenue, Net Subsequent to its regulatory approval in the U.S. in September 2021, the Company began to sell Trudhesa in the U.S. The product is distributed through an exclusive third-party logistics, or 3PL, distribution agent that does not take title to the product. The 3PL distributes Trudhesa to the Company's customers, a specialty pharmacy and a specialty distributor (collectively referred to as "customers"), who then distribute the product to health care providers and patients. In our exclusive distribution agreement with the 3PL company, the Company acts as principal because we retain control of the product. Revenue from product sales is recognized when the customer obtains control of our product, which occurs upon transfer of title to the customer. We classify payments to customers or other parties in the distribution channel for services that are distinct and priced at fair value as selling, general and administrative expenses in our consolidated statements of operations. Payments to customers or other parties in the distribution channel that do not meet those criteria are classified as a reduction of revenue, as discussed further below. Taxes collected from the customer relating to product sales and remitted to governmental authorities are excluded from revenue. Because our payment terms are generally forty-five days, we conclude there is not a significant financing component because the period between the transfer of a promised good or service to the customer and when the customer pays for that good or service will be one year or less. The Company expenses incremental costs of obtaining a contract as and when incurred since the expected amortization period of the asset that we would have recognized is one year or l ess. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, or the transaction price, which includes estimates of variable consideration for which reserves are established and which result from discounts, returns, co-pay assistance, chargebacks, rebates and other allowances that are offered within contracts between us and our customer, health care providers and other indirect customers relating to the sale of Trudhesa. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable or a current liability. Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is considered probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The following are the components of variable consideration related to product revenue: Product Returns : Our customer has limited return rights related to the product’s damage or defect. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of revenue and a refund liability in the period the related product revenue is recognized. Based on the distribution model for Trudhesa and the price of Trudhesa, the Company believes there will be minimal returns. Other incentives : Other incentives include co-payment assistance the Company provides to patients with commercial insurance that have coverage and reside in states that allow co-payment assistance. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that we expect to receive associated with product that has been recognized as revenue. The estimate is recorded as a reduction of revenue in the same period the related revenue is recognized. Managed care rebates : The Company is subject to rebates with certain commercial payers in the future. We record these rebates as an accrual on our consolidated balance sheet in the same period we recognize the related revenue. We estimate our managed care rebates based on our estimated payer mix and the applicable contractual rebate rate. Chargebacks : The Company estimates obligations resulting from contractual commitments with the government and other entities to sell products to qualified healthcare providers and patients at prices lower than the list prices charged to our customer. The government and other entities charge us for the difference between what they pay for the product and the selling price to our customer. The Company records reserves for these chargebacks related to product sold to our customer during the reporting period, as well as our estimate of product that remains in the distribution channel at the end of the reporting period that we expect will be sold to qualified healthcare providers and patients in future periods. As of December 31, 2021, Impel did not enter into any contracts with government entities and other entities that are eligible for chargebacks. Government rebates : The Company is subject to discount obligations under government programs, including Medicaid programs, Medicare and Tricare in the U.S. We estimate Medicaid, Medicare and Tricare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payer mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a liability that is included in accrued expenses on our consolidated balance sheet. For Medicare, we also estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. On a quarterly basis, we update our estimates and record any adjustments in the period that we identify the adjustments. Inventory Prior to receiving approval from the FDA in September 2021 to sell Trudhesa in the U.S., the Company expensed all costs incurred related to the manufacture of Trudhesa as research and development expense because of the inherent risks associated with the development of a drug candidate, the uncertainty about the regulatory approval process and the lack of history for the Company of regulatory approval of drug candidates. Subsequent to receiving FDA approval in September 2021, the Company began to capitalize inventory related costs that were incurred subsequent to FDA approval. T he Company values its inventories at the lower-of-cost or net realizable value and determines the cost of its inventories, which includes costs related to products held for sale in the ordinary course of business, products in process of production for such sale and items to be currently consumed in the production of goods to be available for sale, on a first-in, first-out (FIFO) basis. Due to the nature of the Company’s supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers and contract manufacturers. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and writes down any excess and obsolete inventories to their net realizable value in the period in which the impairment is first identified. If they occur, such impairment charges are recorded as a component of cost of goods sold in the consolidated statements of operations and comprehensive loss. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash. The Company’s cash is deposited with high credit quality financial institutions. At times such deposits may be in excess of the Federal Depository Insurance Corporation insured limits. The Company has exposure to credit risk in accounts receivable from sales of product. As of December 31, 2021, two customers accounted for 100 % of the accounts receivable balance and revenues, with each of these individual customers ranging fro m 46 % to 54 % of the accounts receivable balance. Property and Equipment, Net Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the depreciable assets, ranging from three to four years. Property and equipment are primarily comprised of laboratory and platform equipment used to support manufacturing and research and development activities. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is reflected in the statement of operations in the year of disposition. Additions and improvements that increase the value or extend the life of an asset are capitalized. Repairs and maintenance costs are expensed as incurred. Leasehold improvements are amortized over the remaining term of the lease or the asset’s useful life, whichever is shorter. Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. The recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset or asset group to the estimated undiscounted future cash flows expected to be generated by the asset or asset group. If the carrying amount of an asset or asset group exceeds its estimated undiscounted future cash flows, an impairment charge is recognized as the amount by which the carrying amount of the asset exceeds the estimated discounted future cash flows of the asset or asset group. There have been no such impairments of long-lived assets for any of the periods presented. Fair Value Measurement Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1—Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2—Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active; Level 3— Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying amounts reflected in the accompanying consolidated balance sheets for cash, other current assets, accounts payable, and accrued liabilities approximate their fair values, due to their short-term nature. The C ompany estimated the fair value of long-term debt as of December 31, 2021 was $ 32.5 M and was based on the company’s credit rating and comparison with current prevailing market rates for loans of similar risks and maturities. Leases The Company leases office space and laboratory facilities under non-cancelable operating leases. The Company recognizes rent expense on a straight-line basis over the noncancelable lease period and records the difference between cash rent payments and the recognition of rent expense as a deferred rent liability. When leases contain escalation clauses, rent abatements and landlord or tenant incentives or allowances, these terms are applied in the determination of straight-line rent expense over the lease period. Convertible Notes In March 2021, the Company issued convertible promissory notes to various investors for an aggregate amount of $ 7.5 million. As permitted under Accounting Standards Codification ("ASC") 825, Financial Instruments ("ASC 825"), the Company elected the fair value option for recognition of the convertible notes. The Company elected the fair value option to allow the Company to eliminate the burden of complying with the requirements for derivative accounting. Under the fair value option, the convertible notes were remeasured at fair value in each reporting period until their conversion in April 2021, with changes in the fair value recognized in the Company’s consolidated statement of operations as other (expense) income, net. Accrued interest on the convertible notes is recorded in other (expense), net. The notes were automatically converted into shares of the Company’s common stock upon the closing of the IPO in April 2021. C ost of Goods Sold Cost of goods sol d consists primarily of third-party manufacturing, distribution, and overhead costs associated with Trudhesa. A portion of the costs of producing Trudhesa sold to date was expensed as research and development prior to the FDA approval of Trudhesa and, therefore, it is not reflected in the cost of goods sold. Cost of goods sold for the year ended December 31, 2021, included a charge of $ 0.2 million related to the write down of inventory to net realizable value in the consolidated statements of operations and comprehensive loss. Research and Development Expense Research and development costs are expensed as incurred and consist primarily of salaries, benefits and other staff-related costs, including associated stock-based compensation, laboratory supplies, nonclinical and clinical studies and trials and related clinical manufacturing costs, costs related to manufacturing preparation, fees paid to other entities that conduct certain research and development activities on the Company’s behalf. Non-refundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized as prepaid expenses until the related goods are delivered or services are performed. Such payments are evaluated for current or long-term classification based on when such services are expected to be received. The Company considers regulatory approval of product candidates to be uncertain, and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. The Company expenses manufacturing costs as incurred to research and development expense for product candidates prior to regulatory approval. If, and when, regulatory approval of a product is obtained, the Company begins capitalizing manufacturing costs related to the approved product into inventory. Selling, General and Administrative Expense Selling, general and administrative expenses are primarily comprised of compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal expenses and other general and administrative costs. The Company expenses the cost of advertising, including promotional expenses, as incurred. Advertising expenses were $ 10.6 million for the year ended December 31, 2021. The Company did no t incur any advertising expenses for the year ended December 31, 2020. Advance Payments and Accruals for Research and Development Services As part of the process of preparing its consolidated financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its research and development efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate research and development expenses in its consolidated financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its research and development efforts. The Company determines advance payments for research and development services and accrual estimates through discussion with applicable personnel and outside service providers as to the progress of clinical trials, or other services completed. The Company adjusts its rate of research and development expense recognition if actual results differ from its estimates. The Company makes estimates of its advance payments and accrued expenses as of each balance sheet date in its consolidated financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. Through December 31, 2021, there had been no material adjustments to the Company’s prior period estimates of advance payments and accruals for research and development expenses. The Company’s research and development advance payments and accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Warrant Liabilities The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10 , Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, ("ASC 480-10"), and then in accordance with ASC 815-40, Derivatives and Hedging -- Contracts in Entity's Own Equity ("ASC 815-40"). Under ASC 480-10, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or must or may require settlement by issuing variable number of shares. If the warrants do not meet liability classification under ASC 480-10, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815-40, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. Liability classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after the issuance date recorded as a component of other (expense) income, net in the accompanying consolidated statements of operations. Equity classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. See Note 6 and 7 for additional details. Stock-Based Compensation The Company recognizes stock-based compensation expense for stock options and restricted stock unit awards on a straight-line basis over the requisite service period. The Company’s stock-based compensation costs for stock options are based upon the grant date fair value of options estimated using the Black-Scholes-Merton option pricing model. This model utilizes as inputs the estimated fair value of the underlying common stock at the measurement date, the estimated term of the stock options (weighted-average period of time that the options granted are expected to be outstanding), risk-free interest rates, expected dividends, and the expected volatility of the Company’s common stock. The Company has elected to recognize forfeitures of share-based payment awards as they occur. In determining the fair value of the stock options granted, the Company uses the Black-Scholes option-pricing model and assumptions discussed below. Each of these inputs is subjective. Fair Value of Common Stock— Prior to the IPO, given the absence of a public trading market, the Company’s board of directors with input from management considered numerous objective and subjective factors to determine the fair value of common stock. The factors included, but were not limited to: (1) third-party valuations of the Company’s common stock; (2) the Company’s stage of development; (3) the status of research and development efforts; (4) the rights, preferences and privileges of the Company’s preferred stock relative to those of the Company’s common stock; (5) the Company’s operating results and financial condition, including the Company’s levels of available capital resources; and (6) equity market conditions affecting comparable public companies; (7) general U.S. market conditions; and (8) the lack of marketability of the Company’s common stock. Following the IPO, as a public trading market for the Company’s common stock has been established, the fair value of the common stock is determined based on the quoted market price of the common stock on the date of grant. Expected Term —The Company’s expected term represents the period that the Company’s stock-based awards are expected to be outstanding. The Company used the simplified method (based on the mid-point between the vesting date and the end of the contractual term) to determine the expected term. Expected Volatility —Since the Company recently completed its IPO and does not have substantial trading history for its common stock, the expected volatility was estimated based on the average historical volatilities for comparable publicly traded pharmaceutical companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their similar size, stage in the life cycle and area of specialty. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Risk-Free Interest Rate —The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of option. Expected Dividend —The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero. The Company recognizes stock-based compensation expense for stock options granted to non-employees based on the estimated fair value of the award as it is more readily measurable than the fair value of the services received. Restricted stock units and performance stock units have a grant-date fair value equal to the fair market value of the underlying stock on the grant date. Compensation expense for performance stocks units with performance metrics is calculated based upon expected achievement of the metrics specified in the grant, or when a grant contains a market condition, the grant date fair value using a Monte Carlo simulation. Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts or existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period of enactment. The Company records a valuation allowance to reduce deferred tax assets to an amount for which realization is more likely than not. The Company recognizes the tax benefit from an uncertain tax position if it is more likely than not that the tax position will be sustained upon examination by the tax authorities, based on the merits of the position. The Company does not believe any uncertain tax positions currently pending will have a material adverse effect on its consolidated financial statements nor does the Company expect any material change in its position in the next 12 months. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. Net Loss Per Share Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period, without consideration of potentially dilutive securities. Diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since the effect of potentially dilutive securities is anti-dilutive given the net loss of the Company. Comprehensive Loss Comprehensive loss represents the change in the Company’s stockholders’ equity (deficit) from all sources other than investments by or distributions to stockholders. The Company has no items of other comprehensive loss; as such, net loss equals comprehensive loss. Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2016-02, Leases , or Topic 842, which supersedes the guidance in former ASC 840, Leases . This standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less may be accounted for as a period cost. In May 2020, the FASB issued ASU No. 2020-05, Revenue from Contracts with Customers (Topic 606) and Leases (Topic 842): Effective Dates for Certain Entities, which deferred the effective dates for non-public entities. Therefore, this standard is effective for annual reporting periods, and interim periods within those years, for public entities beginning after December 15, 2018 and for private entities beginning after December 15, 2021. As an Emerging Growth Company, we have elected to follow the private company adoption timeline for ASC 842. Originally, a modified retrospective transition approach was required for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. In July 2018, the FASB issued guidance to permit an alternative transition method for Topic 842, which allows transition to the new lease standard by recognizing a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Entities may elect to apply either approach. There are also a number o |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The following table summarizes the fair value of the Company’s financial liabilities measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): December 31, 2021 Level 1 Level 2 Level 3 Total Liabilities: Common stock warrant liabilities $ — $ — $ 637 $ 637 Total financial liabilities $ — $ — $ 637 $ 637 December 31, 2020 Level 1 Level 2 Level 3 Total Liabilities: Redeemable convertible preferred stock warrant liabilities $ — $ — $ 2,622 $ 2,622 Total financial liabilities $ — $ — $ 2,622 $ 2,622 The following table summarizes the change in the fair value of the common stock warrant liabilities for the year ended December 31, 2021 (in thousands): Beginning balance as of December 31, 2020 $ — Issuance of common stock warrants 751 Change in fair value ( 114 ) Ending balance as of December 31, 2021 $ 637 The following table summarizes the change in the fair value of the redeemable convertible preferred stock warrant liabilities for the year ended December 31, 2021 (in thousands): Beginning balance as of December 31, 2020 $ 2,622 Changes in fair value 55 Settlement upon IPO ( 2,677 ) Ending balance as of December 31, 2021 $ — The following table summarizes the change in the fair value of the convertible notes for the year ended December 31, 2021 (in thousands): Beginning balance as of December 31, 2020 $ — Issuance of convertible notes 7,500 Interest 54 Changes in fair value 839 Conversion upon IPO ( 8,393 ) Ending balance as of December 31, 2021 $ — Fair values of the Company’s common stock warrants, redeemable convertible preferred stock warrant liabilities and convertible notes are based on significant inputs not observed in the market, and thus represent a Level 3 measurement. Refer to Note 6 and Note 7 for the valuation techniques and assumptions used in estimating the fair value of the convertible notes and warrants. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | 4. Balance Sheet Components Inventories Inventories consisted of the following: December 31, Raw materials $ 1,024 Work-in-process 876 Finished goods 924 Total inventories $ 2,824 The Company had no inventories as of December 31, 2020. T he Company recorded a charge of $ 0.2 million in 2021 related to the write down of inventory to net realizable value in the consolidated statements of operations and comprehensive loss. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): December 31, December 31, Refundable clinical deposits $ — $ 672 Tax refund receivable 22 229 Prepaid insurance 1,268 47 Other prepaids and current assets 898 129 Total prepaid expenses and other current assets $ 2,188 $ 1,077 Property and Equipment, Net Property and Equipment, net consisted of the following: December 31, 2021 2020 Laboratory and platform equipment $ 6,590 $ 4,613 Furniture and office equipment 189 100 Leasehold improvements 198 198 Construction in progress 79 1,607 Total property and equipment, gross 7,056 6,518 Less: accumulated depreciation and amortization ( 3,907 ) ( 2,818 ) Total property and equipment, net $ 3,149 $ 3,700 Accrued Liabilities Accrued liabilities consisted of the following (in thousands): December 31, December 31, Accrued compensation $ 5,392 $ 2,393 Accrued professional services 2,004 192 Accrued other liabilities 1,029 333 Accrued sales discounts and allowances 449 — Accrued construction in progress 76 255 Total accrued liabilities $ 8,950 $ 3,173 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies Operating Leases The Company leases office and laboratory space in Seattle, Washington. In December 2021 the Company entered into a non-cancelable operating lease for 7,051 square feet of office space. Rent is payable monthly. As of December 31, 2021, the remaining future minimum lease payments were $ 0.2 million through the expiration date of October 31, 2022 . In September 2017, the Company entered into a non-cancelable operating lease for 11,256 square feet of office and laboratory space. Rent is payable monthly, increasing by approximately 3 % each year. As of December 31, 2021, the remaining future minimum lease payments were $ 0.5 million through the expiration date of August 31, 2022 . Rent expense for the years ended December 31, 2021 and 2020 was $ 0.7 million and $ 0.6 million, respectively. Legal Proceedings From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | 6. Debt Long-term debt consisted of the following (in thousands): December 31, December 31, Face value of term loans $ 30,000 $ 10,000 Final payment 1,950 450 Unamortized debt discount associated with final payment, ( 2,500 ) ( 2,039 ) Total debt, net $ 29,450 $ 8,411 Less: short-term debt — 417 Long-term debt $ 29,450 $ 7,994 Oxford and Silicon Valley Bank Term Loan On July 2, 2021, the Company entered into a loan and security agreement (the "Loan Agreement") with Oxford Finance LLC ("Oxford"), as the collateral agent and a lender, and Silicon Valley Bank ("SVB" and, together with Oxford, the “Lenders”), as a lender, pursuant to which the Lenders have agreed to lend the Company up to an aggregate of $ 50.0 million in a series of term loans (the “Term Loan”). Upon entering into the Loan Agreement, the Company received net proceeds of $ 9.2 million from the Lenders after deducting approximately $ 10.8 million of such amount applied to the repayment of the outstanding principal, interest and final payment fees owed pursuant to the Company’s prior loan and security agreement with Avenue Venture Opportunities Fund, L.P. (“Avenue”) dated November 5, 2020. Under the terms of the Loan Agreement, the Company may, at its sole discretion, borrow from the Lenders up to an additional $10.0 million (the “Term B Loan”) upon the achievement by the Company of NDA approval from the FDA of Trudhesa, as determined by Oxford in its sole and absolute discretion (the “Term B Milestone Event”). On September 30, 2021, upon the occurrence of the Term B Milestone Event, the Company borrowed $ 10.0 million under the Term B Loan. The Company may, at its sole discretion, borrow from the Lenders up to an additional $ 20.0 million (the “Term C Loan”) upon the achievement by the Company of net revenue for a trailing six (6) month period of at least $ 15.0 million, as determined by Oxford in its sole and absolute discretion (the “Term C Milestone Event”). The Company may draw the Term C Loan during the period commencing on the date of the occurrence of the Term C Milestone Event and ending on the earliest of (i) December 31, 2022 (ii) the sixtieth (60th) day following the occurrence of the Term C Milestone Event, and (iii) the occurrence of an event of default. The outstanding loan balance accrues interest at the greater of (i) 7.95% or (ii) the sum of (a) the greater of (1) the thirty (30) day U.S. LIBOR or (2) 0.11%, plus (b) 7.84% and will be interest-only period until September 1, 2023, followed by 35 equal monthly payments of principal and interest, if the Term C Milestone Event is not achieved by December 31, 2022. Following the Company’s achievement of the Term C Milestone Event by not later than December 31, 2022, the Term Loans will be interest-only through September 1, 2024, followed by 23 equal monthly payments of principal and interest . All of the Term Loans mature on July 1, 2026 (the “Maturity Date”) and the Company has the option to prepay the outstanding balance prior to maturity, subject to a prepayment fee of 1.0 % to 3.0 % depending upon when the prepayment occurs. Upon repayment of the Term Loans, the Company is required to make a final payment fee to the Lenders equal to 6.5 % of the original principal amount of the Term Loans funded which will be accrued by charges to interest expense over the term of the loans using the effective interest method. The Term Loans are secured by all assets of the Company, other than its intellectual property. The Company has also agreed not to encumber its intellectual property assets, except as permitted by the Loan Agreement. The borrowings maybe subject to financial covenants if the Company draws down on Term C Loan commencing with the quarter ending March 31, 2023. The Loan Agreement also includes subjective acceleration clauses which permit the lenders to accelerate the maturity date under certain circumstances, including, but not limited to, material adverse effects on a Company’s financial status or otherwise. As of December 31, 2021, the Company is in compliance with all covenants in the Loan Agreement. On March 17, 2022, the Company repaid in full the $ 32.9 million aggregate principal amount (including the prepayment fee and final payment fee) of loans outstanding owed to Oxford and SVB (see note 14). In connection with entering into the Loan Agreement and borrowing the Term A Loan and Term B Loan, the Company issued warrants to purchase 71,522 and 23,166 , shares of its common stock, respectively, (the “Warrants”) to the Lenders at a per share exercisable price of $ 8.39 and $ 12.95 , respectively, all with ten year terms. If the Company borrows additional Term Loans under the Loan Agreement, the Company will be required to issue to the Lenders additional warrants exercisable for a number of shares of the Company’s common stock equal to 3.0% of the total additional Term Loans funded by the Lenders divided by the lower of (x) the 10-trading day trailing average closing price prior to such Term Loan funding or (y) the closing price on the day prior to such Term Loan funding. The Company recorded the Warrants as a debt discount, which is classified as a contra-liability against long-term debt on the consolidated balance sheet, and is amortizing the balance over the life of the underlying debt. The offset to the contra-liability is recorded to Common Stock Warrant Liabilities on the consolidated balance sheet as the Warrants do not meet the criteria for equity classification under ASC 815-40 and meet the definition of a derivative. The Company's Warrants are not indexed to the Company’s common stock in the manner contemplated by ASC 815-40 because the warrant provides for an adjustment to the exercise price upon an acquisition. The Warrants were measured at fair value at inception and are subsequently remeasured at each reporting date with changes in fair value recognized as a component of other (expense) income, net in the consolidated statement of operations and other comprehensive loss. The Company determined the fair value of the Term A Loan and Term B Loan warrants at the date of issuance was $ 0.5 million and $ 0.2 million, respectively, using the Black-Scholes-Merton option pricing model based on significant unobservable inputs (Level 3). The significant unobservable inputs used in the fair value measurement of the warrant liabilities were the volatility rate and the contractual term of the warrants. Assumptions used included an expected term of 10 years, stock volatility ranging from 73.0 % to 78.6 % based on the average historical volatilities for comparable publicly traded pharmaceutical companies over a period equal to the term of the warrants, risk-free interest rates ranging from 1.44 % to 1.52 % during the year ended December 31, 2021. The Company incurred $ 0.1 million in debt issuance costs in connection with the closing of the Term A and Term B Loans. Debt issuance costs and discounts are presented in the consolidated balance sheet as a direct deduction from the associated liability and amortized to interest expense over the term of the related debt. Interest expense for the year ended December 31, 2021 was $ 1.3 million and is inclusive of non-cash amortization in the amount of $ 0.3 million related to the amortization of the debt issuance costs and accretion of final payment. Avenue Term Loan On November 5, 2020 the Company entered into a debt and equity financing agreement with Avenue. The agreement provided for a 36-month term loan of up to $ 20.0 million, of which $ 10.0 million ("Avenue Term Loan") was funded at close and (b) an additional $ 10.0 million was available at the Company’s request until December 31, 2021, subject to (i) completion of an underwritten public offering with gross proceeds of at least $ 75.0 million, or a Qualified Offering, (ii) receipt of FDA approval of Trudhesa and (iii) approval by Avenue’s investment committee. The term loan bears interest at the higher of the prime rate or 11 %. In connection with the agreement, the Company granted Avenue warrants for the purchase of shares of 1,762,810 shares of Series D redeemable convertible preferred stock, as disclosed in Note 7. On July 2, 2021, upon entering into the Loan Agreement with Oxford and SVB, the $ 10.8 million of outstanding principal, interest and final payment fees owed under the debt and equity financing agreement with Avenue was repaid by the Lenders. The Company evaluated whether the Oxford and SVB credit facility entered into in July 2021 represented a debt modification or extinguishment in accordance with ASC 470-50, Debt—Modifications and Extinguishments and determined that the existing Avenue Term Loan was extinguished as a result of the full repayment of the Avenue Term Loan and concurrent issuance of a new credit facility with new creditors, Oxford and SVB. The Company recorded a loss of $ 2.0 million on the early extinguishment of debt related to the unamortized debt discount associated with the fair value of the warrants, final payment fee, and unamortized debt issuance costs. The loss on early extinguishment was recognized as a component of other (expense) income, net in the consolidated statement of operations and other comprehensive loss Convertible Promissory Notes In March 2021, the Company issued unsecured convertible promissory notes to various investors for an aggregate amount of $ 7.5 million which were accounted for at fair value. The notes bore interest at a rate of 5.0 % per annum and mature on the earlier of (a) December 31, 2021 and (b) a change of control. The notes were automatically converted into shares of the Company’s common stock upon the closing of the IPO in April 2021. On March 31, 2021, the notes were remeasured to their settlement amount at the IPO date excluding accrued interest due to the proximity of the settlement date to the end of the reporting period. The loss on the increase in fair value on the convertible notes totaled $ 839,000 from their issuance until settlement and is classified as other (expense) income, net in the accompanying consolidated statements of operations. The carrying value of the convertible notes of $ 8.4 million immediately prior to the Company’s IPO subsequently converted into 559,585 shares of common stock upon completion of the IPO. |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock Warrant Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Warrants and Rights Note Disclosure [Abstract] | |
Redeemable Convertible Preferred Stock Warrant Liabilities | 7. Redeemable Convertible Preferred Stock Warrant Liabilities The key terms of the redeemable convertible preferred stock warrant liabilities are summarized in the following table: Number of shares as of Exercisable into: December 31, December 31, Exercise Expiration Series A-2 redeemable convertible preferred stock — 862,471 $ 0.4996 September 30, 2021 Series C-1 redeemable convertible preferred stock — 1,124,877 0.5289 November 16, 2021 Series D redeemable convertible preferred stock — 1,762,810 0.7091 October 31, 2021 Total — 3,750,158 The fair value of the warrants was determined using an option pricing model. Under this model, the estimated equity value of the Company as of the measurement date was allocated to various classes of financial instruments (such as common and redeemable convertible preferred stock and warrants to purchase redeemable convertible preferred stock) based on their rights and preferences in an assumed liquidity scenario, which was estimated to occur in two years. Other assumptions used prior to the IPO included stock volatility ranging from 46.4 % to 103.0 % and risk-free interest rates ranging from 0.04 % to 0.24 % during the three months ended March 31, 2021. In April 2021, upon completion of the IPO, the Series A-2 and C-1 redeemable convertible preferred stock warrants were cash or net exercised into an aggregate of 61,515 shares of common stock. The Series D redeemable convertible preferred stock warrants were exchanged for 107,663 shares of common stock. |
Redeemable Convertible Prefer_2
Redeemable Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2021 | |
Temporary Equity Disclosure [Abstract] | |
Redeemable Convertible Preferred Stock | 8. Redeemable Convertible Preferred Stock Redeemable convertible preferred stock consisted of the following (in thousands, except share amounts) as of December 31, 2020: Redeemable Convertible Shares Authorized Shares Issued and Carrying Value at Aggregate Series A-1 746,426 746,426 $ 238 $ 305 Series A-2 9,869,218 8,805,587 4,147 4,399 Series B 3,968,775 3,968,775 3,980 4,421 Series C-1 43,278,699 42,153,822 20,975 22,297 Series C-2 26,537,826 26,537,826 15,390 15,000 Series C-3 24,605,790 24,605,790 14,973 15,000 Series D 95,191,755 95,191,755 67,336 67,500 Total 204,198,489 202,009,981 $ 127,039 $ 128,922 Classification The Company classified its redeemable convertible preferred stock as mezzanine equity on the consolidated balance sheets as the shares were contingently redeemable with passage of time or upon deemed liquidation events, such as a change in control. As only the passage of time was required for Series B, C-1, C-2, C-3, and D preferred stock to become redeemable, the Company accreted the carrying value of the preferred stock shares to their redemption value, using the effective interest method, over the period from issuance to the earliest payment dates. Amounts recorded for the accretion of redeemable convertible preferred stock during the years ended December 31, 2021 and 2020 were $ 129,000 and $ 518,000 , respectively. The accretion is recorded as a deemed dividend and a charge to additional paid-in capital. In April 2021, immediately prior to the completion of the IPO (see Note 1), all outstanding shares of redeemable convertible preferred stock were automatically converted into 12,605,800 shares of common stock. Upon conversion into common stock, the carrying value of the redeemable convertible preferred stock of $ 127.2 million was reclassified to equity. |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Common Stock | 9. Common Stock Each share of common stock has the right to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders of all classes of stock outstanding having priority rights as to dividends. No cash dividends have been declared by the board of directors from inception. The Company has reserved the following shares of common stock for issuance, on an as-converted basis, as follows: December 31, December 31, Stock incentive plans 5,324,202 2,786,345 Exercise of common stock warrants 94,688 — Redeemable convertible preferred stock — 12,605,800 Redeemable convertible preferred stock warrants — 229,034 Total 5,418,890 15,621,179 |
Stock Incentive Plan
Stock Incentive Plan | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock Incentive Plan | 10. Stock Incentive Plan 2021 Equity Incentive Plan The Company adopted its 2021 Stock Incentive Plan, or the 2021 Plan, and the Employee Stock Purchase Plan, or the ESPP, which became effective on the date immediately prior to the date of effectiveness of the IPO. The 2021 Plan serves as the successor to its 2018 Equity Incentive Plan (the “2018 Plan”). The 2021 Plan authorizes the award of stock options, RSUs, restricted stock awards, stock bonus awards, stock appreciation rights, performance awards, and cash awards. The Company initially reserved 2,205,000 shares of its common stock for the 2021 Plan, plus any reserved shares not issued or subject to outstanding grants under the 2018 Plan on the effective date of the 2021 Plan, for issuance pursuant to awards granted under its 2021 Plan. The total number of shares reserved for issuance under the 2021 Plan upon its effective date is 2,272,613 shares and approximately 1,216,719 shares were available for future grants as of December 31, 2021. The number of Shares available for issuance under the 2021 Plan will increase automatically on January 1 of each of 2022 through 2031 by the lesser of (a) 5 % of the total number of outstanding shares of all classes of its common stock on each December 31 and (b) a number as may be determined by its board of directors. The Company has reserved 276,000 shares of its common stock for the ESPP. At December 31, 2021, options to purchase 980,313 shares under the 2021 Plan remained outstanding. 2008 Plan In September 2008, the Company’s board of directors adopted the 2008 Stock Incentive Plan, or the 2008 Plan, which provides for the granting of incentive stock options, nonqualified stock options, and restricted stock awards to its employees, directors and consultants. Options granted or shares issued under the 2008 Plan that were outstanding on the date the 2018 Equity Incentive Plan, or the 2018 Plan, became effective will remain subject to the terms of the 2008 Plan. The 2008 Plan terminated in 2018 as it reached its ten-year term. At December 31, 2021 and 2020, options to purchase 473,492 and 634,788 shares, respectively, under the 2008 Plan remained outstanding. 2018 Plan In November 2018, the Company’s board of directors adopted the 2018 Equity Incentive Plan. The 2018 Plan provides for the granting of incentive stock options, nonqualified stock options, restricted stock units, and other forms of stock awards to its employees, directors and consultants. Under the 2018 Plan, the Company initially reserved 753,645 shares of common stock for issuance. In addition, any authorized shares not issued or subject to outstanding grants under the 2008 Plan and any shares subject to outstanding stock options that are cancelled without being exercised or expire under the 2008 Plan were added to the shares authorized and reserved for issuance under the 2018 Plan. In connection with the Board of Directors approval of the 2021 Plan, all remaining shares available for future award under the 2018 Plan were transferred to the 2021 Plan. At December 31, 2021 and 2020, options to purchase 1,892,106 and 1,807,101 shares, respectively, under 2018 Plan remained outstanding. Stock-Based Compensation Expense Non-cash share-based compensation is measured at the grant date based on the fair value of the award and is recognized as expense over the requisite service period of the award using the straight-line method. Non-cash share-based compensation expense, consisting of expense for stock options, RSUs, and PSUs was classified in the consolidated statements of operations as follows (in thousands): Twelve Months Ended 2021 2020 Cost of goods sold $ 17 $ — Research and development 657 488 General and administrative 2,456 3,153 Total stock-based compensation expense $ 3,130 $ 3,641 Stock Option Activity All stock option grants are awarded at fair value on the date of grant. The fair value of stock options is estimated using the Black-Scholes option pricing model and stock-based compensation is recognized on a straight-line basis over the requisite service period. Stock options granted generally become exercisable over a four-year period from the grant date. Stock options generally expire 10 years after the grant date. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company's common shares for those stock options that had exercise prices lower than the fair value of the Company's common shares at December 31, 2021. A summary of the Company’s stock option activity under its stock option plans was as follows (in thousands, except share and per share data and years): Number of Weighted Remaining Aggregate Balance — December 31, 2020 2,441,889 $ 5.17 8.0 $ 14,844 Authorized — Granted 1,305,974 $ 12.10 Exercised ( 249,687 ) $ 3.19 Cancelled ( 152,264 ) $ 7.60 Balance — December 31, 2021 3,345,912 $ 7.91 8.1 $ 6,662 Exercisable — December 31, 2021 1,374,783 $ 4.88 7.0 $ 5,341 As of December 31, 2021, there was $ 10.9 million of total unrecognized compensation cost related to unvested options that are expected to vest. The cost is expected to be recognized over a weighted-average period of 3.1 years. In May 2020, the Company’s board of directors increased the pool of stock options available for future grant by 596,414 shares and appointed an existing member of the board of directors as the Company’s Chief Executive Officer. In connection with this change, the Company granted 715,358 stock options to its Chief Executive Officer at an exercise price of $ 7.86 per share that will vest ratably over 48 months . Vesting of the Chief Executive Officer’s options accelerate upon a termination without cause. In the second quarter 2020, the Company recognized $ 2.1 million of expense related to a modification upon the acceleration of the former Chief Executive Officer’s outstanding options upon his departure from the Company. The fair value of stock option awards granted to employees was estimated at the date of grant using a Black-Scholes-Merton option pricing model with the following assumptions: Twelve Months Ended 2021 2020 Expected term (in years) 6.1 6.1 Expected volatility 59.2 % - 85.5 % 56.4 % - 60.9 % Risk-free interest rate 0.42 % - 1.30 % 0.27 % - 1.55 % Expected dividends — — Restricted Stock Units The Company’s Restricted Stock Units ("RSUs") are considered non-vested share awards and require no payment from the employee. For each RSU, employees receive one share of common stock at the end of the vesting period. The employee can elect to receive the one share of common stock net of taxes or pay for taxes separately and receive the entire share. The fair value of a restricted stock unit award at the grant date is equal to the market price of the Company's common stock on the grant date. Compensation expense is recorded based on the market price of the Company’s common stock on the grant date and is recognized on a straight-line basis over the requisite service period. As of December 31, 2021, there was $ 0.1 million of total unrecognized compensation cost related to the Company's RSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of 1.0 year. There were no RSUs that vested during the year ended December 31, 2021 or 2020. During 2021, the Compensation Committee of the Board of Directors approved the Trudhesa Launch Equity Incentive Plan for awards of performance-based restricted stock units (PSUs) to certain senior executives of the Company. Each award reflects a target number of shares (“Target Shares”) that may be issued to the award recipient. These awards may be earned upon the completion of two-year performance periods ending December 31, 2022, and December 31, 2023. Whether units are earned at the end of the performance period will be determined based on the achievement of certain revenue targets over the performance period. The PSUs also include a performance objective relating to total shareholder return (“TSR”). TSR reflects the change in the value of the Company’s common stock over each performance period. Depending on the revenue achieved and the TSR during the two-year performance periods, the actual number of shares that a grant recipient receives at the end of the performance period may range from 0 % to 125 % of the Target Shares granted for the 2022 performance period and 0 % to 150 % of the Target Shares granted for the 2023 performance period. In the period it becomes probable that the minimum threshold specified in the award will be achieved, we recognize expense for the proportionate share of the total fair value of the PSUs related to the vesting period that has already lapsed for the shares expected to vest and be released. The remaining fair value of the shares expected to vest and be released is expensed on a straight-line basis over the balance of the vesting period. In the event the Company determines it is no longer probable that we will achieve the minimum threshold specified in the award, we reverse all of the previously recognized compensation expense in the period such a determination is made. The fair value of the Target Shares and restricted stock awards are based on the fair value of the underlying shares on the date of grant. The fair value of the portion of the Target Shares that relate to a relative TSR performance objective was determined using a Monte Carlo simulation analy sis to estimate the total shareholder return ranking of the Company among a peer group over the remaining performance periods. The expected volatility of the Company’s common stock at the date of grant was estimated based on the average historical volatilities for comparable publicly traded pharmaceutical companies. The Company used an expected dividend yield of zero . The risk-free interest rate assumption was based on observed interest rates consistent with the approximate two-year performance measure ment period. The fair value of PSUs granted to employees was estimated at the date of grant using the following assumptions: December 31, 2021 2021 Contractual term (in years) 2.1 Expected volatility 0.83 % Risk-free interest rate 0.70 % Expected dividends — As of December 31, 2021, there was $ 4.3 million of total unrecognized compensation cost related to the Company's PSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of 2.2 years. There were no PSUs that vested during the year ended December 31, 2021. The following table is a summary of the restricted stock unit activity for the year ended December 31, 2021: Number of Weighted Number of Weighted Unvested restricted stock outstanding as of December 31, 2020 — $ — — $ — Granted 10,571 9.71 475,000 9.33 Forfeited — — — — Vested — — — — Unvested restricted stock outstanding as of December 31, 2021 10,571 $ 9.71 475,000 $ 9.33 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes The components of loss before taxes were as follows (in thousands): Year Ended December 31, 2021 2020 Domestic $ ( 76,512 ) $ ( 45,801 ) Foreign ( 22 ) 4 Total loss before provision for income tax $ ( 76,534 ) $ ( 45,797 ) The provision for income taxes consisted of the following (in thousands): Year Ended December 31, 2021 2020 Current: Federal $ — $ — State 2 1 Foreign — — Total current tax expense $ 2 $ 1 Reconciliation of income tax computed at federal statutory rates to the reported provision for income taxes was as follows (in thousands): Year Ended December 31, 2021 2020 Tax provision at U.S. statutory rate $ ( 16,072 ) $ ( 9,617 ) State taxes ( 5,725 ) 1 Permanent differences 551 695 Change in valuation allowance 21,567 9,374 Research and development credits ( 576 ) ( 849 ) Other 257 397 Provision for income taxes $ 2 $ 1 Significant components of the Company’s deferred income taxes at December 31, 2021 and 2020 are shown below (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating losses $ 44,540 $ 25,239 Research and development and other tax credits 5,286 4,740 Other 2,964 1,244 Total deferred tax assets 52,790 31,223 Total deferred tax liabilities — — Less valuation allowance ( 52,790 ) ( 31,223 ) Net deferred tax asset $ — $ — In accordance with the authoritative guidance for income taxes under ASC 740, a deferred tax asset or liability is recognized for the expected future tax consequences of temporary differences between the financial statement carrying amounts and tax bases of assets and liabilities. At December 31, 2021, the Company had federal net operating loss, or NOL, and research and development credit carryforwards of approximately $ 21.4 million and $ 7.2 million, respectively. These carryforwards begin to expire in 2028 and 2029 , respectively. In addition, the Company has $ 167.1 million of post 2017 federal NOL carryforwards that carry forward indefinitely. Utilization of the post 2017 federal NOL carryforwards is limited to eighty-percent of taxable income generated in a given tax year. The Company also has $ 69.2 million of state net operating losses, which begin to expire in 2036 . Under Sections 382 and 383 of the Internal Revenue Code of 1986 as amended, or IRC, the Company’s NOL and research and development credit carryforwards and other deferred tax assets may be limited or lost if cumulative changes in ownership exceeds 50% within any rolling three-year period. The Company has not completed an IRC Section 382/383 analysis regarding the limitation of NOL and credit carryforwards. If a change in ownership were to have occurred, the annual limitation may result in the expiration of NOL carryforwards and credits before utilization. If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. In evaluating its valuation allowance, the Company considers all available positive and negative evidence, including scheduled reversals of deferred tax liabilities, projected future taxable income, tax planning strategies, and recent financial performance. Due to uncertainty with respect to ultimate realizability of deferred tax assets, the Company has provided a valuation allowance against the U.S. deferred tax assets. The valuation allowance increased by $ 21.6 million and $ 9.6 million during the years ended December 31, 2021 and 2020, respectively, primarily due to NOLs incurred. The following table presents a reconciliation of the changes in the unrecognized tax benefit (in thousands): Balance as of December 31, 2019 $ 1,605 Increases related to prior year tax positions 9 Increases related to current year tax positions 534 Balance as of December 31, 2020 2,148 Decreases related to prior year tax positions ( 117 ) Increases related to current year tax positions 365 Balance as of December 31, 2021 $ 2,396 The Company does not anticipate the amount of unrecognized tax benefits to significantly change within the next 12 months. Due to the valuation allowance recorded against the Company’s deferred tax assets, none of the total unrecognized tax benefits as of December 31, 2021 and 2021, would reduce the effective tax rate if recognized. As of December 31, 2021 and 2020, there are no penalties or accrued interest recorded in the consolidated financial statements. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. The Company files tax returns with the U.S. federal, California state, and Australian tax authorities. The Company currently has no years under examinations by any jurisdiction; however, the Company is subject to income tax examinations by Federal, California and Australian tax authorities for years beginning in 2018, 2017, and 2016, respectively. Further, to the extent allowed by law, the taxing authorities may have the right to examine prior originating periods when NOLs and tax credits are being utilized in the current year. The Company has made the accounting policy election to recognize the impact of Global Intangible Low-Tax Income as a period cost. |
Defined Contribution Plan
Defined Contribution Plan | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan | 12. Defined Contribution Plan The Company has a defined contribution retirement savings plan under Section 401(k) of the IRC. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax or after-tax basis. The Company makes discretionary matching contributions of up to 4 % of a participating employee’s salary. For the years ended December 31, 2021 and 2020, the amount expensed under the plan was $ 0.4 million and $ 0.3 million, respectively. |
Net Loss Per Share Attributable
Net Loss Per Share Attributable to Common Stockholders | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share Attributable to Common Stockholders | 13. Net Loss Per Share Attributable to Common Stockholders The following outstanding shares of potentially dilutive securities were excluded from the computation of the diluted net loss per share attributable to common stockholders for the periods presented because their effect would have been anti-dilutive: Year Ended December 31, 2021 2020 Stock options to purchase common stock 3,345,912 2,441,889 Non-vested RSUs and PSUs 485,571 — Warrants to purchase common stock 94,688 — Redeemable convertible preferred stock on an as-converted basis — 12,605,800 Redeemable convertible preferred stock warrants on an as-converted basis — 229,034 Total 3,926,171 15,276,723 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 14. Subsequent Events Oaktree Loan and Security Agreement On March 17, 2022 ("Closing Date") , the Company entered into a senior secured loan agreement and related security agreements ("Senior Credit Agreement") with Oaktree Fund Administration, LLC as administrative agent, and the lenders party thereto (collectively “Oaktree”) under which it borrowed $ 50.0 million. The term loan has a maturity date of March 17, 2027 , initially bearing interest at the Secured Overnight Financing Rate ("SOFR") + 8.75 % (with a SOFR floor of 1.00%). Once Trudhesa achieves at least $ 125.0 million in net sales, interest will step down to SOFR + 8.00 % (with a SOFR floor of 1.00%). The Company is required to make quarterly interest-only payments until the fourth anniversary of the Closing Date, after which the Company is required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. Prepayments of the loan, in whole or in part, will subject to early prepayment fee which declines each year until the fourth anniversary date of the Closing Date, after which no prepayment fee is required. The Company is also required to pay an exit fee upon any payment or prepayment equal to 2.0 % of the aggregate principal amount of the loans funded under the Senior Credit Agreement. The Senior Credit Agreement contains customary representations, warranties, events of default and covenants of the Company and its subsidiaries, including a requirement to maintain a minimum $ 12.5 million unrestricted cash balance at all times. A portion of the loan proceeds were used to repay in full the $ 32.9 million aggregate principal amount (including the prepayment fee and final payment fee) of loans outstanding owed to Oxford and SVB by the Company. T he Company expects to record a loss on the early extinguishment of debt related to the unamortized debt discount associated with the fair value of the warrants, final payment fee, and unamortized debt issuance costs. Revenue Interest Financing Agreement On March 17, 2022, the Company entered into a Revenue Interest Financing Agreement ("RIF") with certain purchasers party thereto (collectively “Purchasers”) and Oaktree Fund Administration, LLC as administrative agent (in such capacity, “RIF Agent”), pursuant to which the Company sold to the Purchasers the right to receive payments from us at a tiered percentage (the “Applicable Tiered Percentage”), of future net revenues of Trudhesa, including worldwide net product sales and upfront payments, and milestones, (collectively, “the Revenue Interests”). Under the terms of the agreement, the Company received $ 50.0 million (“Investment Amount”), less certain transaction expenses, in exchange for tiered royalty payments on worldwide net sales from Trudhesa, as follows: 7.75 % on annual United States net sales up to $ 150.0 million; 4.75 % on annual United States net sales between $ 150 million and $ 300 million; 0.75 % on annual United States net sales greater than $ 300.0 million; and 10 % of any upfront payments, milestone payments and royalties received by us from licensing or partnerships relating to Trudhesa outside the United States. The Purchaser’s rights to receive the Revenue Interests shall terminate on the date on which the Purchasers have received payments equal to 175 % of the funded portion of the Investment Amount including the aggregate of all payments made to the Purchasers as of such date, unless the Revenue Interest Financing Agreement is earlier terminated. If the Purchasers have not received payments equal to the 175 % of the funded portion of the Investment Amount by the nine-year anniversary of the initial closing date, among other things, the Company shall pay the Purchasers an amount equal to the funded portion of the Investment Amount plus a specific annual rate of return less payments previously received. Under the RIF, the Company has an option (the “Call Option”) to repurchase future Revenue Interests at any time until the third anniversary of the Closing Date upon advance written notice. Additionally, the Purchasers have an option (the “Put Option”) to terminate the RIF and to require the Company to repurchase future Revenue Interests upon enumerated events such as a bankruptcy event, a material adverse effect or a change of control. If the Put Option or the Call Option are exercised, the required repurchase price is an amount equal to (a) 1.25 multiplied by (b) the Investment Amount, (ii) as of any date on or after the one-year anniversary of the Closing Date and before the two-year anniversary of the Closing Date, an amount equal to (a) 1.40 multiplied by (b) the Investment Amount, (iii) as of any date on or after the two-year anniversary of the Closing Date and before the three-year anniversary of the Closing Date, an amount equal to (a) 1.55 multiplied by (b) the Investment Amount, and (iv) as of any date on or after the three-year anniversary of the Closing Date, an amount equal to (a) 1.75 multiplied by (b) the Investment Amount, in each case net of the sum of any payments received by the Purchasers prior to such Put Option Closing Date or Call Option Closing Date, as applicable. If the Purchasers have not received 100 % of the Investment Amount by February 15, 2027, the first tier royalty rate will be subject to an increase from 7.75 % to 10.75 %. The Company's obligations under the RIF are secured, subject to customary permitted liens and other agreed upon exceptions and subject to an intercreditor agreement with Oaktree Fund Administration, LLC, as administrative agent for the lenders under the Senior Credit Agreement, by a perfected security interest in (i) accounts receivable arising from net sales of Trudhesa and (ii) intellectual property that is claiming or covering Trudhesa, or any method of using, making or manufacturing Trudhesa, including regulatory approvals, clinical data and all other Trudhesa assets. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying audited consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP. The consolidated financial statements include the operations of Impel Neuropharma, Inc., and its wholly owned Australian subsidiary. All intercompany balances and transactions have been eliminated upon consolidation. |
Reclassifications | Reclassifications We have reclassified prior period financial statements to conform to the current period presentation. We reclassified certain amounts previously recorded as general and administrative expense to res earch and development expense. The reclassification had no impact on total operating costs, loss from operations, net loss, stockholders’ equity (deficit) or cash flows. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, management evaluates such estimates and assumptions for continued reasonableness. In particular, management makes estimates with respect to revenue recognition, inventory valuation, the fair values of common stock (prior to the Company's IPO), common stock and redeemable convertible preferred stock warrant liabilities, stock-based compensation expense, convertible debt and income taxes. Appropriate adjustments, if any, to the estimates used are made prospectively based upon such periodic evaluation. Actual results could differ from those estimates. |
Segments | Segments The Company’s chief operating decision maker is its Chief Executive Officer. The Chief Executive Officer reviews financial information on an aggregate basis for the purposes of evaluating financial performance and allocating the Company’s resources. Accordingly, the Company has determined that it operates in one segment. Substantially all of the Company’s assets are located in the U.S. |
Cash | Cash The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be cash equivalents. At December 31, 2021 and 2020, cash consisted of cash in bank deposits held at financial institutions. |
Accounts Receivable, net | Accounts Receivable, net The Company’s trade accounts receivable consists of amounts due from specialty pharmacies and specialty distributors in the U.S. net of distribution service fees, prompt pay discounts and other adjustments. The Company's contracts with customers have standard payment terms that generally require payment within 45 days . The Company analyzes accounts that are past due for collectability, and periodically evaluates the creditworthiness of its customers. As of December 31, 2021, we determined an allowance for doubtful accounts was not req uired based upon our review of contractual payment terms and individual customer circumstances. The Company had no accounts receivable related to product sales in 2020. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. Product Revenue, Net Subsequent to its regulatory approval in the U.S. in September 2021, the Company began to sell Trudhesa in the U.S. The product is distributed through an exclusive third-party logistics, or 3PL, distribution agent that does not take title to the product. The 3PL distributes Trudhesa to the Company's customers, a specialty pharmacy and a specialty distributor (collectively referred to as "customers"), who then distribute the product to health care providers and patients. In our exclusive distribution agreement with the 3PL company, the Company acts as principal because we retain control of the product. Revenue from product sales is recognized when the customer obtains control of our product, which occurs upon transfer of title to the customer. We classify payments to customers or other parties in the distribution channel for services that are distinct and priced at fair value as selling, general and administrative expenses in our consolidated statements of operations. Payments to customers or other parties in the distribution channel that do not meet those criteria are classified as a reduction of revenue, as discussed further below. Taxes collected from the customer relating to product sales and remitted to governmental authorities are excluded from revenue. Because our payment terms are generally forty-five days, we conclude there is not a significant financing component because the period between the transfer of a promised good or service to the customer and when the customer pays for that good or service will be one year or less. The Company expenses incremental costs of obtaining a contract as and when incurred since the expected amortization period of the asset that we would have recognized is one year or l ess. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, or the transaction price, which includes estimates of variable consideration for which reserves are established and which result from discounts, returns, co-pay assistance, chargebacks, rebates and other allowances that are offered within contracts between us and our customer, health care providers and other indirect customers relating to the sale of Trudhesa. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable or a current liability. Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is considered probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The following are the components of variable consideration related to product revenue: Product Returns : Our customer has limited return rights related to the product’s damage or defect. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of revenue and a refund liability in the period the related product revenue is recognized. Based on the distribution model for Trudhesa and the price of Trudhesa, the Company believes there will be minimal returns. Other incentives : Other incentives include co-payment assistance the Company provides to patients with commercial insurance that have coverage and reside in states that allow co-payment assistance. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that we expect to receive associated with product that has been recognized as revenue. The estimate is recorded as a reduction of revenue in the same period the related revenue is recognized. Managed care rebates : The Company is subject to rebates with certain commercial payers in the future. We record these rebates as an accrual on our consolidated balance sheet in the same period we recognize the related revenue. We estimate our managed care rebates based on our estimated payer mix and the applicable contractual rebate rate. Chargebacks : The Company estimates obligations resulting from contractual commitments with the government and other entities to sell products to qualified healthcare providers and patients at prices lower than the list prices charged to our customer. The government and other entities charge us for the difference between what they pay for the product and the selling price to our customer. The Company records reserves for these chargebacks related to product sold to our customer during the reporting period, as well as our estimate of product that remains in the distribution channel at the end of the reporting period that we expect will be sold to qualified healthcare providers and patients in future periods. As of December 31, 2021, Impel did not enter into any contracts with government entities and other entities that are eligible for chargebacks. Government rebates : The Company is subject to discount obligations under government programs, including Medicaid programs, Medicare and Tricare in the U.S. We estimate Medicaid, Medicare and Tricare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payer mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a liability that is included in accrued expenses on our consolidated balance sheet. For Medicare, we also estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. On a quarterly basis, we update our estimates and record any adjustments in the period that we identify the adjustments. |
Inventory | Inventory Prior to receiving approval from the FDA in September 2021 to sell Trudhesa in the U.S., the Company expensed all costs incurred related to the manufacture of Trudhesa as research and development expense because of the inherent risks associated with the development of a drug candidate, the uncertainty about the regulatory approval process and the lack of history for the Company of regulatory approval of drug candidates. Subsequent to receiving FDA approval in September 2021, the Company began to capitalize inventory related costs that were incurred subsequent to FDA approval. T he Company values its inventories at the lower-of-cost or net realizable value and determines the cost of its inventories, which includes costs related to products held for sale in the ordinary course of business, products in process of production for such sale and items to be currently consumed in the production of goods to be available for sale, on a first-in, first-out (FIFO) basis. Due to the nature of the Company’s supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers and contract manufacturers. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and writes down any excess and obsolete inventories to their net realizable value in the period in which the impairment is first identified. If they occur, such impairment charges are recorded as a component of cost of goods sold in the consolidated statements of operations and comprehensive loss. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash. The Company’s cash is deposited with high credit quality financial institutions. At times such deposits may be in excess of the Federal Depository Insurance Corporation insured limits. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the depreciable assets, ranging from three to four years. Property and equipment are primarily comprised of laboratory and platform equipment used to support manufacturing and research and development activities. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is reflected in the statement of operations in the year of disposition. Additions and improvements that increase the value or extend the life of an asset are capitalized. Repairs and maintenance costs are expensed as incurred. Leasehold improvements are amortized over the remaining term of the lease or the asset’s useful life, whichever is shorter. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. The recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset or asset group to the estimated undiscounted future cash flows expected to be generated by the asset or asset group. If the carrying amount of an asset or asset group exceeds its estimated undiscounted future cash flows, an impairment charge is recognized as the amount by which the carrying amount of the asset exceeds the estimated discounted future cash flows of the asset or asset group. There have been no such impairments of long-lived assets for any of the periods presented. |
Fair Value Measurement | Fair Value Measurement Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1—Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2—Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active; Level 3— Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying amounts reflected in the accompanying consolidated balance sheets for cash, other current assets, accounts payable, and accrued liabilities approximate their fair values, due to their short-term nature. The C ompany estimated the fair value of long-term debt as of December 31, 2021 was $ 32.5 M and was based on the company’s credit rating and comparison with current prevailing market rates for loans of similar risks and maturities. |
Leases | Leases The Company leases office space and laboratory facilities under non-cancelable operating leases. The Company recognizes rent expense on a straight-line basis over the noncancelable lease period and records the difference between cash rent payments and the recognition of rent expense as a deferred rent liability. When leases contain escalation clauses, rent abatements and landlord or tenant incentives or allowances, these terms are applied in the determination of straight-line rent expense over the lease period. |
Convertible Notes | Convertible Notes In March 2021, the Company issued convertible promissory notes to various investors for an aggregate amount of $ 7.5 million. As permitted under Accounting Standards Codification ("ASC") 825, Financial Instruments ("ASC 825"), the Company elected the fair value option for recognition of the convertible notes. The Company elected the fair value option to allow the Company to eliminate the burden of complying with the requirements for derivative accounting. Under the fair value option, the convertible notes were remeasured at fair value in each reporting period until their conversion in April 2021, with changes in the fair value recognized in the Company’s consolidated statement of operations as other (expense) income, net. Accrued interest on the convertible notes is recorded in other (expense), net. The notes were automatically converted into shares of the Company’s common stock upon the closing of the IPO in April 2021. C ost of Goods Sold Cost of goods sol d consists primarily of third-party manufacturing, distribution, and overhead costs associated with Trudhesa. A portion of the costs of producing Trudhesa sold to date was expensed as research and development prior to the FDA approval of Trudhesa and, therefore, it is not reflected in the cost of goods sold. Cost of goods sold for the year ended December 31, 2021, included a charge of $ 0.2 million related to the write down of inventory to net realizable value in the consolidated statements of operations and comprehensive loss. |
Research and Development Expense | Research and Development Expense Research and development costs are expensed as incurred and consist primarily of salaries, benefits and other staff-related costs, including associated stock-based compensation, laboratory supplies, nonclinical and clinical studies and trials and related clinical manufacturing costs, costs related to manufacturing preparation, fees paid to other entities that conduct certain research and development activities on the Company’s behalf. Non-refundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized as prepaid expenses until the related goods are delivered or services are performed. Such payments are evaluated for current or long-term classification based on when such services are expected to be received. The Company considers regulatory approval of product candidates to be uncertain, and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. The Company expenses manufacturing costs as incurred to research and development expense for product candidates prior to regulatory approval. If, and when, regulatory approval of a product is obtained, the Company begins capitalizing manufacturing costs related to the approved product into inventory. |
Selling, General and Administrative Expense | Selling, General and Administrative Expense Selling, general and administrative expenses are primarily comprised of compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal expenses and other general and administrative costs. The Company expenses the cost of advertising, including promotional expenses, as incurred. Advertising expenses were $ 10.6 million for the year ended December 31, 2021. The Company did no t incur any advertising expenses for the year ended December 31, 2020. |
Advance Payments and Accruals for Research and Development Services | Advance Payments and Accruals for Research and Development Services As part of the process of preparing its consolidated financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its research and development efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate research and development expenses in its consolidated financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its research and development efforts. The Company determines advance payments for research and development services and accrual estimates through discussion with applicable personnel and outside service providers as to the progress of clinical trials, or other services completed. The Company adjusts its rate of research and development expense recognition if actual results differ from its estimates. The Company makes estimates of its advance payments and accrued expenses as of each balance sheet date in its consolidated financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. Through December 31, 2021, there had been no material adjustments to the Company’s prior period estimates of advance payments and accruals for research and development expenses. The Company’s research and development advance payments and accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. |
Warrant Liabilities | Warrant Liabilities The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10 , Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, ("ASC 480-10"), and then in accordance with ASC 815-40, Derivatives and Hedging -- Contracts in Entity's Own Equity ("ASC 815-40"). Under ASC 480-10, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or must or may require settlement by issuing variable number of shares. If the warrants do not meet liability classification under ASC 480-10, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815-40, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. Liability classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after the issuance date recorded as a component of other (expense) income, net in the accompanying consolidated statements of operations. Equity classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. See Note 6 and 7 for additional details. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes stock-based compensation expense for stock options and restricted stock unit awards on a straight-line basis over the requisite service period. The Company’s stock-based compensation costs for stock options are based upon the grant date fair value of options estimated using the Black-Scholes-Merton option pricing model. This model utilizes as inputs the estimated fair value of the underlying common stock at the measurement date, the estimated term of the stock options (weighted-average period of time that the options granted are expected to be outstanding), risk-free interest rates, expected dividends, and the expected volatility of the Company’s common stock. The Company has elected to recognize forfeitures of share-based payment awards as they occur. In determining the fair value of the stock options granted, the Company uses the Black-Scholes option-pricing model and assumptions discussed below. Each of these inputs is subjective. Fair Value of Common Stock— Prior to the IPO, given the absence of a public trading market, the Company’s board of directors with input from management considered numerous objective and subjective factors to determine the fair value of common stock. The factors included, but were not limited to: (1) third-party valuations of the Company’s common stock; (2) the Company’s stage of development; (3) the status of research and development efforts; (4) the rights, preferences and privileges of the Company’s preferred stock relative to those of the Company’s common stock; (5) the Company’s operating results and financial condition, including the Company’s levels of available capital resources; and (6) equity market conditions affecting comparable public companies; (7) general U.S. market conditions; and (8) the lack of marketability of the Company’s common stock. Following the IPO, as a public trading market for the Company’s common stock has been established, the fair value of the common stock is determined based on the quoted market price of the common stock on the date of grant. Expected Term —The Company’s expected term represents the period that the Company’s stock-based awards are expected to be outstanding. The Company used the simplified method (based on the mid-point between the vesting date and the end of the contractual term) to determine the expected term. Expected Volatility —Since the Company recently completed its IPO and does not have substantial trading history for its common stock, the expected volatility was estimated based on the average historical volatilities for comparable publicly traded pharmaceutical companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their similar size, stage in the life cycle and area of specialty. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Risk-Free Interest Rate —The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of option. Expected Dividend —The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero. The Company recognizes stock-based compensation expense for stock options granted to non-employees based on the estimated fair value of the award as it is more readily measurable than the fair value of the services received. Restricted stock units and performance stock units have a grant-date fair value equal to the fair market value of the underlying stock on the grant date. Compensation expense for performance stocks units with performance metrics is calculated based upon expected achievement of the metrics specified in the grant, or when a grant contains a market condition, the grant date fair value using a Monte Carlo simulation. |
Income Taxes | Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts or existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period of enactment. The Company records a valuation allowance to reduce deferred tax assets to an amount for which realization is more likely than not. The Company recognizes the tax benefit from an uncertain tax position if it is more likely than not that the tax position will be sustained upon examination by the tax authorities, based on the merits of the position. The Company does not believe any uncertain tax positions currently pending will have a material adverse effect on its consolidated financial statements nor does the Company expect any material change in its position in the next 12 months. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. |
Net Loss Per Share Attributable to Common Stockholders | Net Loss Per Share Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period, without consideration of potentially dilutive securities. Diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since the effect of potentially dilutive securities is anti-dilutive given the net loss of the Company. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss represents the change in the Company’s stockholders’ equity (deficit) from all sources other than investments by or distributions to stockholders. The Company has no items of other comprehensive loss; as such, net loss equals comprehensive loss. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2016-02, Leases , or Topic 842, which supersedes the guidance in former ASC 840, Leases . This standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less may be accounted for as a period cost. In May 2020, the FASB issued ASU No. 2020-05, Revenue from Contracts with Customers (Topic 606) and Leases (Topic 842): Effective Dates for Certain Entities, which deferred the effective dates for non-public entities. Therefore, this standard is effective for annual reporting periods, and interim periods within those years, for public entities beginning after December 15, 2018 and for private entities beginning after December 15, 2021. As an Emerging Growth Company, we have elected to follow the private company adoption timeline for ASC 842. Originally, a modified retrospective transition approach was required for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. In July 2018, the FASB issued guidance to permit an alternative transition method for Topic 842, which allows transition to the new lease standard by recognizing a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Entities may elect to apply either approach. There are also a number of optional practical expedients that entities may elect to apply. The Company is currently assessing the impact of this standard on its consolidated financial statements. Recently Adopted Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity , or ASU 2020-06, which simplifies accounting for convertible instruments by removing major separation models required under current U.S. GAAP. ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. ASU 2020-06 is effective for the Company for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020 and adoption must be as of the beginning of the Company’s annual fiscal year. The Company early adopted this standard on January 1, 2021 and the adoption of the standard did not have a significant impact on its consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value, Liabilities Measured on Recurring Basis | The following table summarizes the fair value of the Company’s financial liabilities measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): December 31, 2021 Level 1 Level 2 Level 3 Total Liabilities: Common stock warrant liabilities $ — $ — $ 637 $ 637 Total financial liabilities $ — $ — $ 637 $ 637 December 31, 2020 Level 1 Level 2 Level 3 Total Liabilities: Redeemable convertible preferred stock warrant liabilities $ — $ — $ 2,622 $ 2,622 Total financial liabilities $ — $ — $ 2,622 $ 2,622 |
Summary of Change in Fair Value of Redeemable Convertible Preferred Stock Warrant Liabilities and Convertible notes | The following table summarizes the change in the fair value of the redeemable convertible preferred stock warrant liabilities for the year ended December 31, 2021 (in thousands): Beginning balance as of December 31, 2020 $ 2,622 Changes in fair value 55 Settlement upon IPO ( 2,677 ) Ending balance as of December 31, 2021 $ — The following table summarizes the change in the fair value of the convertible notes for the year ended December 31, 2021 (in thousands): Beginning balance as of December 31, 2020 $ — Issuance of convertible notes 7,500 Interest 54 Changes in fair value 839 Conversion upon IPO ( 8,393 ) Ending balance as of December 31, 2021 $ — |
Summary of Change in the Fair Value of the Common Stock Warrant Liabilities | The following table summarizes the change in the fair value of the common stock warrant liabilities for the year ended December 31, 2021 (in thousands): Beginning balance as of December 31, 2020 $ — Issuance of common stock warrants 751 Change in fair value ( 114 ) Ending balance as of December 31, 2021 $ 637 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Inventories | Inventories consisted of the following: December 31, Raw materials $ 1,024 Work-in-process 876 Finished goods 924 Total inventories $ 2,824 |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consisted of the following (in thousands): December 31, December 31, Refundable clinical deposits $ — $ 672 Tax refund receivable 22 229 Prepaid insurance 1,268 47 Other prepaids and current assets 898 129 Total prepaid expenses and other current assets $ 2,188 $ 1,077 |
Schedule of Property and Equipment, Net | Property and Equipment, net consisted of the following: December 31, 2021 2020 Laboratory and platform equipment $ 6,590 $ 4,613 Furniture and office equipment 189 100 Leasehold improvements 198 198 Construction in progress 79 1,607 Total property and equipment, gross 7,056 6,518 Less: accumulated depreciation and amortization ( 3,907 ) ( 2,818 ) Total property and equipment, net $ 3,149 $ 3,700 |
Schedule of accrued liabilities | Accrued liabilities consisted of the following (in thousands): December 31, December 31, Accrued compensation $ 5,392 $ 2,393 Accrued professional services 2,004 192 Accrued other liabilities 1,029 333 Accrued sales discounts and allowances 449 — Accrued construction in progress 76 255 Total accrued liabilities $ 8,950 $ 3,173 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term debt | Long-term debt consisted of the following (in thousands): December 31, December 31, Face value of term loans $ 30,000 $ 10,000 Final payment 1,950 450 Unamortized debt discount associated with final payment, ( 2,500 ) ( 2,039 ) Total debt, net $ 29,450 $ 8,411 Less: short-term debt — 417 Long-term debt $ 29,450 $ 7,994 |
Redeemable Convertible Prefer_3
Redeemable Convertible Preferred Stock Warrant Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Warrants and Rights Note Disclosure [Abstract] | |
Schedule of Outstanding Redeemable Convertible Preferred Stock Warrant Liabilities | The key terms of the redeemable convertible preferred stock warrant liabilities are summarized in the following table: Number of shares as of Exercisable into: December 31, December 31, Exercise Expiration Series A-2 redeemable convertible preferred stock — 862,471 $ 0.4996 September 30, 2021 Series C-1 redeemable convertible preferred stock — 1,124,877 0.5289 November 16, 2021 Series D redeemable convertible preferred stock — 1,762,810 0.7091 October 31, 2021 Total — 3,750,158 |
Redeemable Convertible Prefer_4
Redeemable Convertible Preferred Stock (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Redeemable Convertible Preferred Stock | Redeemable convertible preferred stock consisted of the following (in thousands, except share amounts) as of December 31, 2020: Redeemable Convertible Shares Authorized Shares Issued and Carrying Value at Aggregate Series A-1 746,426 746,426 $ 238 $ 305 Series A-2 9,869,218 8,805,587 4,147 4,399 Series B 3,968,775 3,968,775 3,980 4,421 Series C-1 43,278,699 42,153,822 20,975 22,297 Series C-2 26,537,826 26,537,826 15,390 15,000 Series C-3 24,605,790 24,605,790 14,973 15,000 Series D 95,191,755 95,191,755 67,336 67,500 Total 204,198,489 202,009,981 $ 127,039 $ 128,922 |
Common Stock (Tables)
Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Schedule of Reserved Shares of Common Stock for Issuance, on an as-Converted Basis | The Company has reserved the following shares of common stock for issuance, on an as-converted basis, as follows: December 31, December 31, Stock incentive plans 5,324,202 2,786,345 Exercise of common stock warrants 94,688 — Redeemable convertible preferred stock — 12,605,800 Redeemable convertible preferred stock warrants — 229,034 Total 5,418,890 15,621,179 |
Stock Incentive Plan (Tables)
Stock Incentive Plan (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Non cash Share-Based Compensation Expense | Non-cash share-based compensation expense, consisting of expense for stock options, RSUs, and PSUs was classified in the consolidated statements of operations as follows (in thousands): Twelve Months Ended 2021 2020 Cost of goods sold $ 17 $ — Research and development 657 488 General and administrative 2,456 3,153 Total stock-based compensation expense $ 3,130 $ 3,641 |
Summary of the Company's Stock Option Activity under its Stock Option Plans | A summary of the Company’s stock option activity under its stock option plans was as follows (in thousands, except share and per share data and years): Number of Weighted Remaining Aggregate Balance — December 31, 2020 2,441,889 $ 5.17 8.0 $ 14,844 Authorized — Granted 1,305,974 $ 12.10 Exercised ( 249,687 ) $ 3.19 Cancelled ( 152,264 ) $ 7.60 Balance — December 31, 2021 3,345,912 $ 7.91 8.1 $ 6,662 Exercisable — December 31, 2021 1,374,783 $ 4.88 7.0 $ 5,341 |
Summary of Restricted Stock Unit Activity | The following table is a summary of the restricted stock unit activity for the year ended December 31, 2021: Number of Weighted Number of Weighted Unvested restricted stock outstanding as of December 31, 2020 — $ — — $ — Granted 10,571 9.71 475,000 9.33 Forfeited — — — — Vested — — — — Unvested restricted stock outstanding as of December 31, 2021 10,571 $ 9.71 475,000 $ 9.33 |
PSUs [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Fair Value of Stock Option Awards Granted to Employees | The fair value of PSUs granted to employees was estimated at the date of grant using the following assumptions: December 31, 2021 2021 Contractual term (in years) 2.1 Expected volatility 0.83 % Risk-free interest rate 0.70 % Expected dividends — |
Stock Options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Fair Value of Stock Option Awards Granted to Employees | The fair value of stock option awards granted to employees was estimated at the date of grant using a Black-Scholes-Merton option pricing model with the following assumptions: Twelve Months Ended 2021 2020 Expected term (in years) 6.1 6.1 Expected volatility 59.2 % - 85.5 % 56.4 % - 60.9 % Risk-free interest rate 0.42 % - 1.30 % 0.27 % - 1.55 % Expected dividends — — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Provision for Income Taxes | The components of loss before taxes were as follows (in thousands): Year Ended December 31, 2021 2020 Domestic $ ( 76,512 ) $ ( 45,801 ) Foreign ( 22 ) 4 Total loss before provision for income tax $ ( 76,534 ) $ ( 45,797 ) |
Schedule of provision for income taxes | The provision for income taxes consisted of the following (in thousands): Year Ended December 31, 2021 2020 Current: Federal $ — $ — State 2 1 Foreign — — Total current tax expense $ 2 $ 1 |
Schedule of Reconciliation of income tax computed at federal statutory rates | Reconciliation of income tax computed at federal statutory rates to the reported provision for income taxes was as follows (in thousands): Year Ended December 31, 2021 2020 Tax provision at U.S. statutory rate $ ( 16,072 ) $ ( 9,617 ) State taxes ( 5,725 ) 1 Permanent differences 551 695 Change in valuation allowance 21,567 9,374 Research and development credits ( 576 ) ( 849 ) Other 257 397 Provision for income taxes $ 2 $ 1 |
Schedule of Significant components of deferred income taxes | Significant components of the Company’s deferred income taxes at December 31, 2021 and 2020 are shown below (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating losses $ 44,540 $ 25,239 Research and development and other tax credits 5,286 4,740 Other 2,964 1,244 Total deferred tax assets 52,790 31,223 Total deferred tax liabilities — — Less valuation allowance ( 52,790 ) ( 31,223 ) Net deferred tax asset $ — $ — |
Summary of Activity Related to Unrecognized Tax Benefits | The following table presents a reconciliation of the changes in the unrecognized tax benefit (in thousands): Balance as of December 31, 2019 $ 1,605 Increases related to prior year tax positions 9 Increases related to current year tax positions 534 Balance as of December 31, 2020 2,148 Decreases related to prior year tax positions ( 117 ) Increases related to current year tax positions 365 Balance as of December 31, 2021 $ 2,396 |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable to Common Stockholders (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Outstanding Shares of Potentially Dilutive Securities Excluded from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders | The following outstanding shares of potentially dilutive securities were excluded from the computation of the diluted net loss per share attributable to common stockholders for the periods presented because their effect would have been anti-dilutive: Year Ended December 31, 2021 2020 Stock options to purchase common stock 3,345,912 2,441,889 Non-vested RSUs and PSUs 485,571 — Warrants to purchase common stock 94,688 — Redeemable convertible preferred stock on an as-converted basis — 12,605,800 Redeemable convertible preferred stock warrants on an as-converted basis — 229,034 Total 3,926,171 15,276,723 |
Organization and Description _2
Organization and Description of Business - Additional Information (Details) - USD ($) | Apr. 23, 2021 | Mar. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
Date of incorporation | Jul. 24, 2008 | ||||
Proceeds from initial public offering, net of issuance costs | $ 71,997,000 | ||||
Proceeds from issuance of common stock, net of underwriters discount and commissions | 71,997,000 | ||||
Conversion of convertible notes, amout converted | $ 127,168,000 | ||||
Reverse stock split, description | effect a reverse split of shares of the Company’s common stock on an one-for-16.37332 basis, which was effected on April 16, 2021 (the “Reverse Stock Split”). The number of authorized shares and the par values of the common stock and redeemable convertible preferred stock were not adjusted as a result of the Reverse Stock Split. In connection with the Reverse Stock Split, the conversion ratio for the Company’s outstanding redeemable convertible preferred stock was proportionately adjusted such that the common stock issuable upon conversion of such preferred stock was decreased in proportion to the Reverse Stock Split. | ||||
Proceeds from issuance or sale of equity, debt and warrants | $ 292,800,000 | ||||
Cash | $ 88,212,000 | $ 7,095,000 | |||
Common Stock | |||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
Conversion of redeemable convertible preferred stock to common stock upon initial public offering, Shares | 12,605,800 | ||||
Common shares exercised | 61,515 | ||||
Common Stock | Avenue Venture Opportunities Fund L P | |||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
Conversion of warrant, shares converted | 107,663 | ||||
Warrant to Purchase Common Stock [Member] | Avenue Venture Opportunities Fund L P | |||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
Conversion of warrant, shares converted | 1,987,348 | ||||
Convertible Notes [Member] | |||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
Conversion of redeemable convertible preferred stock to common stock upon initial public offering, Shares | 559,585 | ||||
Conversion of convertible notes, amout converted | $ 7,500,000 | ||||
Discount of initial public offering price | 10.00% | ||||
Initial public offering | |||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
Proceeds from initial public offering, net of underwriters' discounts and commissions, Shares | 5,333,334 | ||||
Shares price per share | $ 15 | ||||
Proceeds from initial public offering, net of issuance costs | $ 72,000,000 | ||||
Payments of stock issuance offering costs | 2,400 | ||||
Payment of underwriting discounts, commissions | 5,600,000 | ||||
Proceeds from issuance of common stock, net of underwriters discount and commissions | $ 72,000,000 | ||||
follow-on public offering | |||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
Proceeds from initial public offering, net of underwriters' discounts and commissions, Shares | 3,450,000 | ||||
Shares price per share | $ 15 | ||||
Proceeds from initial public offering, net of issuance costs | $ 48,300,000 | ||||
Payments of stock issuance offering costs | 600,000 | ||||
Payment of underwriting discounts, commissions | 2,800 | ||||
Proceeds from issuance of common stock, net of underwriters discount and commissions | $ 48,300,000 | ||||
Underwriter Public Offering [Member] | |||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
Proceeds from initial public offering, net of underwriters' discounts and commissions, Shares | 450,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021USD ($)Segment | Dec. 31, 2020USD ($) | Mar. 31, 2021USD ($) | |
Debt Instrument [Line Items] | |||
Number of operating segments | Segment | 1 | ||
Write-down of inventory to net realizable value | $ 199 | ||
Advertising expenses | 10,600 | 0 | |
Impairment Of Long Lived Assets | 0 | $ 0 | |
Long-term Debt, Fair Value | 32,500 | ||
Unrecognized tax benefits | $ 0 | ||
Credit Concentration Risk | Accounts Receivable | Customer One | |||
Debt Instrument [Line Items] | |||
Percentage of accounts receivable balance | 46.00% | ||
Credit Concentration Risk | Accounts Receivable | Customer Two | |||
Debt Instrument [Line Items] | |||
Percentage of accounts receivable balance | 54.00% | ||
Credit Concentration Risk | Accounts Receivable | Customers | |||
Debt Instrument [Line Items] | |||
Percentage of accounts receivable balance | 100.00% | ||
Contracts With Customers | |||
Debt Instrument [Line Items] | |||
Standard Payments Terms | 45 days | ||
Convertible Promissory Notes | |||
Debt Instrument [Line Items] | |||
Issued convertible promissory notes | $ 7,500 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value, Liabilities Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Liabilities: | ||
Total financial liabilities | $ 637 | $ 2,622 |
Redeemable Convertible Preferred Stock Warrant Liability [Member] | ||
Liabilities: | ||
Total financial liabilities | 0 | 2,622 |
Convertible Notes [Member] | ||
Liabilities: | ||
Total financial liabilities | 0 | 0 |
Warrant Liabilities [Member] | ||
Liabilities: | ||
Total financial liabilities | 637 | |
Level 1 [Member] | ||
Liabilities: | ||
Total financial liabilities | 0 | |
Level 1 [Member] | Redeemable Convertible Preferred Stock Warrant Liability [Member] | ||
Liabilities: | ||
Total financial liabilities | 0 | |
Level 1 [Member] | Warrant Liabilities [Member] | ||
Liabilities: | ||
Total financial liabilities | ||
Level 2 [Member] | ||
Liabilities: | ||
Total financial liabilities | 0 | |
Level 2 [Member] | Redeemable Convertible Preferred Stock Warrant Liability [Member] | ||
Liabilities: | ||
Total financial liabilities | 0 | |
Level 2 [Member] | Warrant Liabilities [Member] | ||
Liabilities: | ||
Total financial liabilities | ||
Level 3 [Member] | ||
Liabilities: | ||
Total financial liabilities | 637 | 2,622 |
Level 3 [Member] | Redeemable Convertible Preferred Stock Warrant Liability [Member] | ||
Liabilities: | ||
Total financial liabilities | $ 2,622 | |
Level 3 [Member] | Warrant Liabilities [Member] | ||
Liabilities: | ||
Total financial liabilities | $ 637 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Change in the Fair Value of the Common Stock Warrant Liabilities (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Beginning balance as of December 31, 2020 | |
Ending balance as of September 30, 2021 | 23 |
Common Stock Warrant Liabilities [Member] | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Beginning balance as of December 31, 2020 | 0 |
Issuance of common stock warrants | 751 |
Change in fair value | 114 |
Ending balance as of September 30, 2021 | $ 637 |
Fair Value Measurements - Sum_3
Fair Value Measurements - Summary of Change in Fair Value of Redeemable Convertible Preferred Stock Warrant Liabilities and Convertible notes (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Beginning balance | $ 2,622 |
Ending balance | 637 |
Redeemable Convertible Preferred Stock Warrant Liability [Member] | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Beginning balance | 2,622 |
Changes in fair value | 55 |
Liabilities fair value settlement upon IPO | (2,677) |
Ending balance | 0 |
Convertible Notes [Member] | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Beginning balance | 0 |
Changes in fair value | 839 |
Issuance of convertible notes | 7,500 |
Liabilities fair value conversion upon IPO | (8,393) |
Liabilities fair value interest | 54 |
Ending balance | $ 0 |
Balance Sheet Components (Addit
Balance Sheet Components (Additional Information) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Balance Sheet Related Disclosures [Abstract] | ||
Inventory | $ 2,824 | $ 0 |
Inventory Write-down | $ 199 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 1,024 | |
Work-in-process | 876 | |
Finished goods | 924 | |
Total inventories | $ 2,824 | $ 0 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Refundable clinical deposits | $ 0 | $ 672 |
Tax refund receivable | 22 | 229 |
Prepaid insurance | 1,268 | 47 |
Other prepaids and current assets | 898 | 129 |
Total prepaid expenses and other current assets | $ 2,188 | $ 1,077 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property and Equipment, Net [Line Items] | ||
Total property and equipment, gross | $ 7,056 | $ 6,518 |
Less: accumulated depreciation and amortization | (3,907) | (2,818) |
Total property and equipment, net | 3,149 | 3,700 |
Laboratory and Platform Equipment [Member] | ||
Property and Equipment, Net [Line Items] | ||
Total property and equipment, gross | 6,590 | 4,613 |
Furniture and Office Equipment [Member] | ||
Property and Equipment, Net [Line Items] | ||
Total property and equipment, gross | 189 | 100 |
Leasehold Improvements [Member] | ||
Property and Equipment, Net [Line Items] | ||
Total property and equipment, gross | 198 | 198 |
Construction in Progress [Member] | ||
Property and Equipment, Net [Line Items] | ||
Total property and equipment, gross | $ 79 | $ 1,607 |
Balance Sheet Components - Sc_4
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Accrued compensation | $ 5,392 | $ 2,393 |
Accrued professional services | 2,004 | 192 |
Accrued other liabilities | 1,029 | 333 |
Accrued sales discounts and allowances | 449 | |
Accrued construction in progress | 76 | 255 |
Total accrued liabilities | $ 8,950 | $ 3,173 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021USD ($)ft² | Dec. 31, 2020USD ($) | Sep. 30, 2017ft² | |
Finite-Lived Intangible Assets [Line Items] | |||
Non cancelable operating lease area | ft² | 7,051 | 11,256 | |
Percentage increase in rent payable monthly | 3.00% | ||
Rent expenses | $ 0.7 | $ 0.6 | |
December 2021 Non Cancelable Operating Lease [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Remaining future minimum lease payments | $ 0.2 | ||
Operating lease expiration date | Oct. 31, 2022 | ||
September 2017 Non Cancelable Operating Lease [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Remaining future minimum lease payments | $ 0.5 | ||
Operating lease expiration date | Aug. 31, 2022 |
Debt - Additional Information (
Debt - Additional Information (Details) | Mar. 17, 2022USD ($) | Jul. 02, 2021USD ($) | Nov. 05, 2020USD ($)shares | Mar. 31, 2021USD ($)shares | Jun. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)shares | Apr. 23, 2021$ / shares |
Debt Instrument [Line Items] | |||||||||
Long-term debt, description | The outstanding loan balance accrues interest at the greater of (i) 7.95% or (ii) the sum of (a) the greater of (1) the thirty (30) day U.S. LIBOR or (2) 0.11%, plus (b) 7.84% and will be interest-only period until September 1, 2023, followed by 35 equal monthly payments of principal and interest, if the Term C Milestone Event is not achieved by December 31, 2022. Following the Company’s achievement of the Term C Milestone Event by not later than December 31, 2022, the Term Loans will be interest-only through September 1, 2024, followed by 23 equal monthly payments of principal and interest | ||||||||
Net revenue | $ 15,000,000 | ||||||||
Final Payment Percentage of Principal Amount Term Loan | 6.50% | ||||||||
Common Stock Issued As Warrant Exercisable | shares | 23,123,062 | 755,478 | |||||||
Loss on early extinguishment of debt | $ (2,000,000) | $ 1,993,000 | |||||||
Expected volatility rate, minimum | 46.40% | ||||||||
Expected volatility rate, maximum | 103.00% | ||||||||
Risk-free interest rate, minimum | 0.04% | ||||||||
Risk-free interest rate, maximum | 0.24% | ||||||||
Face value of term loan | $ 30,000,000 | 10,000,000 | |||||||
Loss on increase in fair value of convertible notes. | $ 839,000 | ||||||||
Fair value of term loan | 32,500,000 | ||||||||
Carrying amount of term loan | $ 1,950,000 | $ 450,000 | |||||||
Repayments of Bank Debt | $ 32,900,000 | ||||||||
Convertible Notes On Conversion Basis [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Conversion of convertible notes to common shares at IPO | shares | 559,585 | ||||||||
IPO [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Warrant Exercise Price Per Share | $ / shares | $ 15 | ||||||||
Carrying value of convertible notes | $ 8,400,000 | ||||||||
Expected Term | |||||||||
Debt Instrument [Line Items] | |||||||||
Expected term | 10 years | ||||||||
Maximum [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Prepayment fee for loan payment | 3.00% | ||||||||
Maximum [Member] | Stock volatility | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, Measurement Input | 78.6 | ||||||||
Maximum [Member] | Risk Free Interest Rate | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, Measurement Input | 1.52 | ||||||||
Minimum [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Prepayment fee for loan payment | 1.00% | ||||||||
Minimum [Member] | Stock volatility | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, Measurement Input | 73 | ||||||||
Minimum [Member] | Risk Free Interest Rate | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, Measurement Input | 1.44 | ||||||||
Term Loan [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Term of loan | 36 months | ||||||||
Current borrowing capacity | $ 10,000,000 | ||||||||
Remaining borrowing capacity | 10,800,000 | $ 10,000,000 | |||||||
Debt instrument interest rate stated percentage | 11.00% | ||||||||
Proceeds from (Repayments of) Secured Debt | 9,200,000 | ||||||||
Outstanding principal, interest and final payment amount | 10,800,000 | ||||||||
Face value of term loan | 50,000,000 | ||||||||
Term Loan [Member] | Series D Preferred Stock [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Granted warrants for the purchase of shares | shares | 1,762,810 | ||||||||
Term Loan [Member] | Maximum [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Maximum credit commitment | $ 20,000,000 | ||||||||
Term Loan [Member] | Minimum [Member] | IPO [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Gross proceeds | $ 75,000,000 | ||||||||
Term A Loan [Member] | Warrant [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Common Stock Issued As Warrant Exercisable | shares | 71,522 | ||||||||
Warrant Exercise Price Per Share | $ / shares | $ 8.39 | ||||||||
Fair value of term loan | $ 500,000 | ||||||||
Term B Loan [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Proceeds from issuance of long-term debt, net of transaction costs | $ 10,000,000 | ||||||||
Term B Loan [Member] | Warrant [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Common Stock Issued As Warrant Exercisable | shares | 23,166 | ||||||||
Warrant Exercise Price Per Share | $ / shares | $ 12.95 | ||||||||
Fair value of term loan | $ 200,000 | ||||||||
Term C Loan [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Term of loan | 35 months | ||||||||
Line of credit facility additional borrowing loan amount | $ 20,000,000 | ||||||||
Maturity date | Jul. 1, 2026 | ||||||||
Term A and Term B Loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Issuance Costs at closing | $ 100,000 | ||||||||
Amortization of Debt Issuance Costs | 300,000 | ||||||||
Interest expense | $ 1,300,000 | ||||||||
Convertible Promissory Notes [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument interest rate stated percentage | 5.00% | ||||||||
Face value of term loan | $ 7,500,000 | ||||||||
Debt instrument, maturity date | Dec. 31, 2021 |
Debt - Schedule of Term Loan (D
Debt - Schedule of Term Loan (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Face value of term loans | $ 30,000 | $ 10,000 |
Final payment | 1,950 | 450 |
Unamortized debt discount associated with final payment, issuance date warrant fair value, and financing costs | (2,500) | (2,039) |
Total debt, net | 29,450 | 8,411 |
Less: short-term debt | 0 | 417 |
Long-term debt | $ 29,450 | $ 7,994 |
Redeemable Convertible Prefer_5
Redeemable Convertible Preferred Stock Warrant Liabilities - Schedule of Outstanding Redeemable Convertible Preferred Stock Warrant Liabilities (Details) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Class Of Warrant Or Right [Line Items] | ||
Redeemable convertible preferred stock warrant liabilities, Number of shares outstanding | 0 | 3,750,158 |
Series A-2 Redeemable Convertible Preferred Stock [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Redeemable convertible preferred stock warrant liabilities, Number of shares outstanding | 0 | 862,471 |
Redeemable convertible preferred stock warrant liabilities, Exercise Price | $ 0.4996 | |
Redeemable convertible preferred stock warrant liabilities, Expiration | Sep. 30, 2021 | |
Series C-1 Redeemable Convertible Preferred Stock [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Redeemable convertible preferred stock warrant liabilities, Number of shares outstanding | 0 | 1,124,877 |
Redeemable convertible preferred stock warrant liabilities, Exercise Price | $ 0.5289 | |
Redeemable convertible preferred stock warrant liabilities, Expiration | Nov. 16, 2021 | |
Series D Redeemable Convertible Preferred Stock [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Redeemable convertible preferred stock warrant liabilities, Number of shares outstanding | 0 | 1,762,810 |
Redeemable convertible preferred stock warrant liabilities, Exercise Price | $ 0.7091 | |
Redeemable convertible preferred stock warrant liabilities, Expiration | Oct. 31, 2021 |
Redeemable Convertible Prefer_6
Redeemable Convertible Preferred Stock Warrant Liabilities - Additional Information (Details) - shares | 1 Months Ended | 12 Months Ended |
Apr. 30, 2021 | Dec. 31, 2021 | |
Class Of Warrant Or Right [Line Items] | ||
Expected volatility rate, minimum | 46.40% | |
Expected volatility rate, maximum | 103.00% | |
Risk-free interest rate, minimum | 0.04% | |
Risk-free interest rate, maximum | 0.24% | |
Series A-2 Redeemable Convertible Preferred Stock [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrant exercised | 61,515 | |
Series D Preferred Stock [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrant exercised | 107,663 |
Redeemable Convertible Prefer_7
Redeemable Convertible Preferred Stock - Summary of Redeemable Convertible Preferred Stock (Details) $ in Thousands | Dec. 31, 2020USD ($)shares |
Temporary Equity [Line Items] | |
Redeemable convertible preferred stock, shares authorized | shares | 204,198,489 |
Shares Issued and Outstanding | shares | 202,009,981 |
Carrying Value | $ | $ 127,039 |
Redeemable convertible preferred stock, liquidation preference value | $ | $ 128,922 |
Series A-1 Redeemable Convertible Preferred Stock [Member] | |
Temporary Equity [Line Items] | |
Redeemable convertible preferred stock, shares authorized | shares | 746,426 |
Shares Issued and Outstanding | shares | 746,426 |
Carrying Value | $ | $ 238 |
Redeemable convertible preferred stock, liquidation preference value | $ | $ 305 |
Series A-2 Redeemable Convertible Preferred Stock [Member] | |
Temporary Equity [Line Items] | |
Redeemable convertible preferred stock, shares authorized | shares | 9,869,218 |
Shares Issued and Outstanding | shares | 8,805,587 |
Carrying Value | $ | $ 4,147 |
Redeemable convertible preferred stock, liquidation preference value | $ | $ 4,399 |
Series B Redeemable Convertible Preferred Stock [Member] | |
Temporary Equity [Line Items] | |
Redeemable convertible preferred stock, shares authorized | shares | 3,968,775 |
Shares Issued and Outstanding | shares | 3,968,775 |
Carrying Value | $ | $ 3,980 |
Redeemable convertible preferred stock, liquidation preference value | $ | $ 4,421 |
Series C-1 Redeemable Convertible Preferred Stock [Member] | |
Temporary Equity [Line Items] | |
Redeemable convertible preferred stock, shares authorized | shares | 43,278,699 |
Shares Issued and Outstanding | shares | 42,153,822 |
Carrying Value | $ | $ 20,975 |
Redeemable convertible preferred stock, liquidation preference value | $ | $ 22,297 |
Series C-2 Redeemable Convertible Preferred Stock [Member] | |
Temporary Equity [Line Items] | |
Redeemable convertible preferred stock, shares authorized | shares | 26,537,826 |
Shares Issued and Outstanding | shares | 26,537,826 |
Carrying Value | $ | $ 15,390 |
Redeemable convertible preferred stock, liquidation preference value | $ | $ 15,000 |
Series C-3 Redeemable Convertible Preferred Stock [Member] | |
Temporary Equity [Line Items] | |
Redeemable convertible preferred stock, shares authorized | shares | 24,605,790 |
Shares Issued and Outstanding | shares | 24,605,790 |
Carrying Value | $ | $ 14,973 |
Redeemable convertible preferred stock, liquidation preference value | $ | $ 15,000 |
Series D Redeemable Convertible Preferred Stock [Member] | |
Temporary Equity [Line Items] | |
Redeemable convertible preferred stock, shares authorized | shares | 95,191,755 |
Shares Issued and Outstanding | shares | 95,191,755 |
Carrying Value | $ | $ 67,336 |
Redeemable convertible preferred stock, liquidation preference value | $ | $ 67,500 |
Redeemable Convertible Prefer_8
Redeemable Convertible Preferred Stock - Additional Information (Details) - Redeemable Convertible Preferred Stock [Member] - USD ($) | Apr. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 |
Temporary Equity [Line Items] | |||
Temporary equity, accretion of dividends | $ 129,000 | $ 518,000 | |
Number of common stock shares issued upon conversion | 12,605,800 | ||
Carrying value reclassified to equity | $ 127,200,000 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) - Common Stock [Member] | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Common stock, voting rights | Each share of common stock has the right to one vote. |
Cash dividends declared | $ 0 |
Common Stock - Schedule of Rese
Common Stock - Schedule of Reserved Shares of Common Stock for Issuance, on an as-Converted Basis (Details) - shares | Dec. 31, 2021 | Dec. 31, 2020 |
Stock Incentive Plans [Member] | ||
Common stock, reserved for future issuance | 5,324,202 | 2,786,345 |
Redeemable Convertible Preferred Stock [Member] | ||
Common stock, reserved for future issuance | 0 | 12,605,800 |
Convertible Notes [Member] | ||
Common stock, reserved for future issuance | 0 | 229,034 |
Common Stock Warrants [Member] | ||
Common stock, reserved for future issuance | 94,688 | |
Redeemable Convertible Preferred Stock Warrant [Member] | ||
Common stock, reserved for future issuance | 5,418,890 | 15,621,179 |
Stock Incentive Plan - Addition
Stock Incentive Plan - Additional Information (Details) - USD ($) | 1 Months Ended | 6 Months Ended | 12 Months Ended | |||
May 31, 2020 | Jun. 30, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options outstanding | 3,345,912 | 2,441,889 | ||||
Remaining Contractual Term (Years), Exercisable | 7 years | |||||
Increase in number of shares available for future grant | 596,414 | |||||
Stock options, grants in period | 1,305,974 | |||||
Stock options, grants in period, weighted-average exercise price | $ 12.10 | |||||
Accelerated cost | $ 2,100,000 | |||||
Unvested stock options, cost not yet recognized, amount | $ 10,900,000 | |||||
Unvested award, cost not yet recognized, period for recognition | 3 years 1 month 6 days | |||||
Stock Options [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Award expiration period | 10 years | |||||
Remaining Contractual Term (Years), Exercisable | 4 years | |||||
Expected dividend yield | 0.00% | 0.00% | ||||
Stock Options [Member] | Chief Executive Officer [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Award vesting period | 48 months | |||||
Stock options, grants in period | 715,358 | |||||
Stock options, grants in period, weighted-average exercise price | $ 7.86 | |||||
RSUs [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options, grants in period | 10,571 | |||||
Stock options, grants in period, weighted-average grant date fair value | $ 9.71 | |||||
Unvested stock options, cost not yet recognized, amount | $ 100,000 | |||||
Unvested award, cost not yet recognized, period for recognition | 1 year | |||||
Shares Vested | 0 | 0 | ||||
PSUs [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options, grants in period | 475,000 | |||||
Stock options, grants in period, weighted-average grant date fair value | $ 9.33 | |||||
Unvested stock options, cost not yet recognized, amount | $ 4,300 | |||||
Unvested award, cost not yet recognized, period for recognition | 2 years 2 months 12 days | |||||
Expected dividend yield | 0.00% | |||||
Shares Vested | 0 | |||||
2008 Stock Incentive Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Plan term | 10 years | |||||
Stock options outstanding | 473,492 | 634,788 | ||||
2018 Stock Incentive Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Common stock, reserved for future issuance | 753,645 | |||||
Stock options outstanding | 1,892,106 | 1,807,101 | ||||
2021 Equity Incentive Plan Policies [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Common stock, reserved for future issuance | 2,205,000 | |||||
Number of shares reserved for issuance. | 2,272,613 | |||||
Shares Available for Future Grants | 1,216,719 | |||||
Stock options outstanding | 980,313 | |||||
Percentage of total number of outstanding shares of common stock | 5.00% | |||||
2021 Employee Stock Purchase Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Common stock, reserved for future issuance | 276,000 | |||||
Total Shareholder Return (TSR) [Member] | PSUs [Member] | Maximum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Target Shares Granted | 150.00% | 125.00% | ||||
Total Shareholder Return (TSR) [Member] | PSUs [Member] | Minimum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Target Shares Granted | 0.00% | 0.00% |
Stock Incentive Plan - Schedule
Stock Incentive Plan - Schedule of Non Cash Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | $ 3,130 | $ 3,641 |
Cost of Goods Sold [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | 17 | |
Research and Development [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | 657 | 488 |
General and Administrative [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | $ 2,456 | $ 3,153 |
Stock Incentive Plan - Summary
Stock Incentive Plan - Summary of the Company's Stock Option Activity under its Stock Option Plans (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Number of Options, Beginning Balance | 2,441,889 | |
Number of Options, Granted | 1,305,974 | |
Number of Options Exercised | (249,687) | |
Number of Options, Cancelled | (152,264) | |
Number of Options, Ending Balance | 3,345,912 | 2,441,889 |
Number of Options, Exercisable | 1,374,783 | |
Weighted-Average Exercise Price, Beginning Balance | $ 5.17 | |
Weighted-Average Exercise Price, Granted | 12.10 | |
Weighted-Average Exercise Price, Exercised | 3.19 | |
Weighted-Average Exercise Price, Cancelled | 7.60 | |
Weighted-Average Exercise Price, Ending Balance | 7.91 | $ 5.17 |
Weighted-Average Exercise Price, Exercisable | $ 4.88 | |
Remaining Contractual Term (Years), Balance | 8 years 1 month 6 days | 8 years |
Remaining Contractual Term (Years), Exercisable | 7 years | |
Aggregate Intrinsic Value, Beginning Balance | $ 14,844 | |
Aggregate Intrinsic Value, Ending Balance | 6,662 | $ 14,844 |
Aggregate Intrinsic Value, Exercisable | $ 5,341 |
Stock Incentive Plan - Schedu_2
Stock Incentive Plan - Schedule of Fair Value of Stock Option Awards Granted to Employees (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock Options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Contractual term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Expected dividends | 0.00% | 0.00% |
Stock Options [Member] | Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility | 59.20% | 56.40% |
Risk-free interest rate | 0.42% | 0.27% |
Stock Options [Member] | Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility | 85.50% | 60.90% |
Risk-free interest rate | 1.30% | 1.55% |
PSUs [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Contractual term (in years) | 2 years 1 month 6 days | |
Expected volatility | 0.83% | |
Risk-free interest rate | 0.70% | |
Expected dividends | 0.00% |
Stock Incentive Plan - Summar_2
Stock Incentive Plan - Summary of Restricted Stock Unit Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Options, Granted | 1,305,974 | |
RSUs [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares Unvested, Beginning Balance | 0 | |
Number of Options, Granted | 10,571 | |
Number of Shares, Forfeited | 0 | |
Number of Shares, Vested | 0 | 0 |
Number of shares Unvested, Ending Balance | 10,571 | 0 |
Weighted Average Grant Date Fair Value Unvested, Beginning Balance | $ 0 | |
Stock options, grants in period, weighted-average grant date fair value | 9.71 | |
Stock options, forfeited in period, weighted-average grant date fair value | 0 | |
Stock options, Vested in period, weighted-average grant date fair value | 0 | |
Weighted Average Grant Date Fair Value Unvested, Ending Balance | $ 9.71 | $ 0 |
PSUs [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares Unvested, Beginning Balance | 0 | |
Number of Options, Granted | 475,000 | |
Number of Shares, Forfeited | 0 | |
Number of Shares, Vested | 0 | |
Number of shares Unvested, Ending Balance | 475,000 | 0 |
Weighted Average Grant Date Fair Value Unvested, Beginning Balance | $ 0 | |
Stock options, grants in period, weighted-average grant date fair value | 9.33 | |
Stock options, forfeited in period, weighted-average grant date fair value | 0 | |
Stock options, Vested in period, weighted-average grant date fair value | 0 | |
Weighted Average Grant Date Fair Value Unvested, Ending Balance | $ 9.33 | $ 0 |
Income Taxes - Summary of provi
Income Taxes - Summary of provision for income tax (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Domestic | $ (76,512) | $ (45,801) |
Foreign | (22) | 4 |
Total loss before provision for income tax | $ (76,534) | $ (45,797) |
Income Taxes - Summary of curre
Income Taxes - Summary of current income tax expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Current: | ||
Federal | $ 0 | $ 0 |
State | 2 | 1 |
Foreign | 0 | 0 |
Total current tax expense | $ 2 | $ 1 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of income tax computed at federal statutory rates (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Tax provision at U.S. statutory rate | $ (16,072) | $ (9,617) |
State Taxes | (5,725) | 1 |
Permanent differences | 551 | 695 |
Change in valuation allowance | 21,567 | 9,374 |
Research and development credits | (576) | (849) |
Other | 257 | 397 |
Provision for income taxes | $ 2 | $ 1 |
Income Taxes - deferred income
Income Taxes - deferred income taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss | $ 44,540 | $ 25,239 |
Research and development and other tax credits | 5,286 | 4,740 |
Other | 2,964 | 1,244 |
Deferred Tax Assets, Gross, Total | 52,790 | 31,223 |
Less valuation allowance | (52,790) | (31,223) |
Deferred Tax Assets, Net of Valuation Allowance, Total | 0 | 0 |
Deferred tax liabilities: | ||
Deferred Tax Liabilities, Gross, Total | $ 0 | $ 0 |
Income Taxes - Summary of unrec
Income Taxes - Summary of unrecognized tax benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Unrecognized Tax Benefits, Beginning Balance | $ 2,148 | $ 1,605 |
Increases related to prior year tax positions | (117) | (9) |
Increases related to current year tax positions | 365 | 534 |
Unrecognized Tax Benefits, Ending Balance | $ 2,396 | $ 2,148 |
Income Taxes (Additional Inform
Income Taxes (Additional Information) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Loss Carryforwards [Line Items] | |||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 21,600 | $ 9,600 | |
Unrecognized Tax Benefits | 2,396 | $ 2,148 | $ 1,605 |
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Operating Loss Carryforwards | $ 21,400 | ||
Operating Loss Carry Forwards Expiration Year | 2028 | ||
State | |||
Operating Loss Carryforwards [Line Items] | |||
Operating Loss Carryforwards | $ 69,200 | ||
Operating Loss Carry Forwards Expiration Year | 2036 | ||
Indefinitely Member | Federal Tax Authority Member | |||
Operating Loss Carryforwards [Line Items] | |||
Operating Loss Carryforwards | $ 167,100 | ||
Research Tax Credit Carryforward [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating Loss Carryforwards | $ 7,200 | ||
Operating Loss Carry Forwards Expiration Year | 2029 |
Defined Contribution Plan - Add
Defined Contribution Plan - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Retirement Benefits [Abstract] | ||
Maximum Employee's Contribution, Percent | 4.00% | |
Expense, Defined Contribution Plan | $ 0.4 | $ 0.3 |
Net Loss Per Share Attributab_3
Net Loss Per Share Attributable to Common Stockholders - Schedule of Outstanding Shares of Potentially Dilutive Securities Excluded from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 3,926,171 | 15,276,723 |
Stock Options [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 3,345,912 | 2,441,889 |
Non-vested RSUs and PSUs [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 485,571 | 0 |
Stock Warrants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 94,688 | 0 |
Redeemable Convertible Preferred Stock on an as-Converted Basis [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 0 | 12,605,800 |
Redeemable Convertible Preferred Stock Warrants on an as Converted Basis [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 0 | 229,034 |
Subsequent Events (Additional I
Subsequent Events (Additional Information) (Details) - USD ($) $ in Millions | Mar. 17, 2022 | Jun. 30, 2020 | Dec. 31, 2021 |
Subsequent Event [Line Items] | |||
Revenues | $ 15 | ||
Repayment of loan | $ 32.9 | ||
Put option and Call option exercised description | the required repurchase price is an amount equal to (a) 1.25 multiplied by (b) the Investment Amount, (ii) as of any date on or after the one-year anniversary of the Closing Date and before the two-year anniversary of the Closing Date, an amount equal to (a) 1.40 multiplied by (b) the Investment Amount, (iii) as of any date on or after the two-year anniversary of the Closing Date and before the three-year anniversary of the Closing Date, an amount equal to (a) 1.55 multiplied by (b) the Investment Amount, and (iv) as of any date on or after the three-year anniversary of the Closing Date, an amount equal to (a) 1.75 multiplied by | ||
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Prepayment fee for Loan Payment | 2.00% | ||
Unrestricted cash balance | $ 12.5 | ||
Repayment of loan | $ 32.9 | ||
Investment, percent | 100.00% | ||
Revenue interest payments | 175.00% | ||
Oaktree Loan and Security Agreement [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Secured Loan borrowed | $ 50 | ||
Term loan, maturity date | Mar. 17, 2027 | ||
Revenue Interest Financing Agreement [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Revenues | $ 50 | ||
Revenue interest payments | 175.00% | ||
Secured Overnight Financing Rate | Oaktree Loan and Security Agreement [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Interest rate | 8.75% | ||
Tradhesa [Member] | Oaktree Loan and Security Agreement [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Interest rate | 8.00% | ||
Revenues | $ 125 | ||
Minimum [Member] | |||
Subsequent Event [Line Items] | |||
Prepayment fee for Loan Payment | 1.00% | ||
Minimum [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Royalty rate | 7.75% | ||
Maximum [Member] | |||
Subsequent Event [Line Items] | |||
Prepayment fee for Loan Payment | 3.00% | ||
Maximum [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Royalty rate | 10.75% | ||
UNITED STATES | Revenue Interest Financing Agreement [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Net sales, percentage | 0.75% | ||
Upfront payments | 10.00% | ||
UNITED STATES | Tradhesa [Member] | Revenue Interest Financing Agreement [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Revenues | $ 150 | ||
UNITED STATES | Minimum [Member] | Revenue Interest Financing Agreement [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Revenues | 150 | ||
UNITED STATES | Minimum [Member] | Tradhesa [Member] | Revenue Interest Financing Agreement [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Revenues | $ 300 | ||
Net sales, percentage | 4.75% | ||
UNITED STATES | Maximum [Member] | Revenue Interest Financing Agreement [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Revenues | $ 300 | ||
UNITED STATES | Maximum [Member] | Tradhesa [Member] | Revenue Interest Financing Agreement [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Net sales, percentage | 7.75% |