Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 29, 2023 | Jun. 30, 2022 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Transition Report | false | ||
Entity File Number | 001-36193 | ||
Entity Registrant Name | TREVENA INC | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 26-1469215 | ||
Entity Address, Address Line One | 955 Chesterbrook Blvd. | ||
Entity Address, Address Line Two | Suite 110 | ||
Entity Address, City or Town | Chesterbrook | ||
Entity Address, State or Province | PA | ||
Entity Address, Postal Zip Code | 19087 | ||
City Area Code | 610 | ||
Local Phone Number | 354-8840 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | TRVN | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Public Float | $ 276 | ||
Entity Common Stock, Shares Outstanding | 8,975,072 | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | Philadelphia, Pennsylvania | ||
Entity Central Index Key | 0001429560 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 38,320 | $ 66,923 |
Inventories | 906 | 2,352 |
Prepaid expenses and other current assets | 1,782 | 1,448 |
Total current assets | 41,008 | 70,723 |
Restricted cash | 1,960 | 1,311 |
Property and equipment, net | 1,488 | 1,841 |
Right-of-use lease asset | 4,224 | 4,706 |
Other assets | 1,543 | |
Total assets | 48,680 | 80,124 |
Current liabilities: | ||
Accounts payable, net | 2,372 | 4,547 |
Accrued expenses and other current liabilities | 5,461 | 3,847 |
Lease liability | 899 | 792 |
Total current liabilities | 8,732 | 9,186 |
Loans payable, net | 13,430 | |
Leases, net of current portion | 5,436 | 6,309 |
Warrant liability | 5,483 | |
Total liabilities | 33,081 | 15,495 |
Stockholders' equity: | ||
Preferred stock-$0.001 par value; 5,000,000 shares authorized, none issued or outstanding at December 31, 2022 and December 31, 2021 | ||
Common stock-$0.001 par value; 200,000,000 shares authorized at December 31, 2022 and December 31, 2021; 7,744,692 and 6,618,093 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 8 | 7 |
Additional paid-in capital | 563,362 | 558,724 |
Accumulated deficit | (547,772) | (494,102) |
Accumulated other comprehensive loss | 1 | |
Total stockholders' equity | 15,599 | 64,629 |
Total liabilities and stockholders' equity | $ 48,680 | $ 80,124 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock issued (in shares) | 0 | 0 |
Preferred stock outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock issued (in shares) | 7,744,692 | 6,618,093 |
Common stock outstanding (in shares) | 7,744,692 | 6,618,093 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue: | ||
Total revenue | $ (418) | $ 567 |
Operating expenses: | ||
Cost of goods sold | 3,018 | 954 |
Selling, general and administrative | 34,728 | 38,112 |
Research and development | 18,211 | 13,426 |
Total operating expenses | 55,957 | 52,492 |
Loss from operations | (56,375) | (51,925) |
Other income (expense): | ||
Change in fair value of warrant liability | 11,180 | 6 |
Other income (expense), net | (7,681) | 172 |
Interest income | 451 | 162 |
Interest expense | (1,256) | (1) |
Loss on foreign currency exchange | 11 | (2) |
Total other income (expense), net | 2,705 | 337 |
Net Loss | (53,670) | (51,588) |
Other comprehensive loss | ||
Unrealized gain on marketable securities | 1 | |
Comprehensive loss | $ (53,669) | $ (51,588) |
Per share information: | ||
Net loss per share of common stock, basic (in dollars per share) | $ (7.59) | $ (7.90) |
Net loss per share of common stock, diluted (in dollars per share) | $ (7.59) | $ (7.90) |
Weighted average common shares outstanding, basic (in shares) | 7,072,362 | 6,529,074 |
Weighted average common shares outstanding, diluted (in shares) | 7,072,362 | 6,529,074 |
Product revenue | ||
Revenue: | ||
Total revenue | $ (438) | $ 498 |
License revenue | ||
Revenue: | ||
Total revenue | $ 20 | $ 69 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total |
Beginning Balance at Dec. 31, 2020 | $ 6 | $ 546,576 | $ (442,514) | $ 104,068 | ||
Beginning Balance (in shares) at Dec. 31, 2020 | 6,397,647 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 4,407 | 4,407 | ||||
Exercise of stock options | 187 | 187 | ||||
Exercise of stock options (in shares) | 5,861 | |||||
Issuance of stock | $ 1 | (395) | (394) | |||
Issuance of stock (in shares) | 170,748 | |||||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes | 7,949 | 7,949 | ||||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes (in shares) | 43,837 | |||||
Net loss | (51,588) | (51,588) | ||||
Ending Balance at Dec. 31, 2021 | $ 7 | 558,724 | (494,102) | $ 64,629 | ||
Ending Balance (in shares) at Dec. 31, 2021 | 6,618,093 | 6,618,093 | ||||
Ending Balance (in shares) at Dec. 31, 2021 | 0 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 3,676 | $ 3,676 | ||||
Issuance of common stock warrants in connection with loan payable | 603 | 603 | ||||
Issuance of stock | $ 397 | $ 1 | (1) | |||
Issuance of stock (in shares) | 2,000 | 765,000 | ||||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes | (37) | (37) | ||||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes (in shares) | 41,599 | |||||
Conversion of preferred stock to common stock | $ (397) | |||||
Conversion of preferred stock to common stock (in shares) | (2,000) | |||||
Conversion of preferred stock to common stock | 397 | 397 | ||||
Conversion of preferred stock to common stock (in shares) | 320,000 | |||||
Unrealized loss on marketable securities | $ 1 | 1 | ||||
Net loss | (53,670) | (53,670) | ||||
Ending Balance at Dec. 31, 2022 | $ 8 | $ 563,362 | $ (547,772) | $ 1 | $ 15,599 | |
Ending Balance (in shares) at Dec. 31, 2022 | 7,744,692 | 7,744,692 | ||||
Ending Balance (in shares) at Dec. 31, 2022 | 0 |
Statements of Stockholders' E_2
Statements of Stockholders' Equity (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, par value (in dollars per share) | 0.001 | 0.001 |
Preferred Stock | ||
Preferred stock, par value (in dollars per share) | 0.001 | 0.001 |
Common Stock | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities: | ||
Net loss | $ (53,670) | $ (51,588) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 382 | 428 |
Stock-based compensation | 3,676 | 4,407 |
Noncash interest expense on loan | 128 | |
Inventory valuation adjustment | 2,070 | |
Fair value of warrants in excess of proceeds | 7,147 | |
Revaluation of warrant liability | (11,180) | (6) |
Returns reserve adjustment | 383 | |
Accretion of bond discount on marketable securities | (46) | |
Change in right-of-use asset | 482 | 413 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 1,209 | (2,337) |
Inventories | (624) | (2,352) |
Insurance recovery | 9,000 | |
Settlement liability | (9,000) | |
Operating lease liabilities | (758) | (695) |
Accounts payable, accrued expenses and other liabilities | (676) | 1,533 |
Net cash used in operating activities | (51,477) | (50,197) |
Investing activities: | ||
Purchases of property and equipment | (28) | (16) |
Maturities of marketable securities | 33,000 | |
Purchases of marketable securities | (32,954) | |
Net cash provided by (used in) investing activities | 18 | (16) |
Financing activities: | ||
Proceeds from exercise of common stock options | 187 | |
Proceeds from issuance of common stock, net | 7,948 | |
Payment of employee withholding taxes on vested restricted stock units | (37) | (393) |
Finance lease payments | (8) | (8) |
Net proceeds from sale of common stock, warrants and pre-funded warrants | 7,997 | |
Proceeds from loan payable | 13,906 | |
Proceeds from issuance of convertible Series A and Series B preferred stock and warrants, net of issuance costs | 1,647 | |
Net cash provided by financing activities | 23,505 | 7,734 |
Net decrease in cash, cash equivalents and restricted cash | (27,954) | (42,479) |
Cash, cash equivalents and restricted cash-beginning of period | 68,234 | 110,713 |
Cash, cash equivalents and restricted cash-end of period | 40,280 | $ 68,234 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | (604) | |
Conversion of Series A and Series B preferred stock to common stock | $ (397) |
Organization and Description of
Organization and Description of the Business | 12 Months Ended |
Dec. 31, 2022 | |
Organization and Description of the Business | |
Organization and Description of the Business | 1. Organization and Description of the Business Trevena, Inc., or the Company, was incorporated in Delaware as Parallax Therapeutics, Inc. on November 9, 2007. The Company began operations in December 2007, and its name was changed to Trevena, Inc. on January 3, 2008. The Company is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients affected by central nervous system, or CNS, disorders. The Company operates in one segment and has its principal office in Chesterbrook, Pennsylvania. Since commencing operations in 2007, the Company has devoted substantially all of its financial resources and efforts to commercialization and research and development, including nonclinical studies and clinical trials. The Company has never been profitable. In late 2017, the Company submitted a new drug application, or NDA, for OLINVYK® (OLINVYK) injection, or OLINVYK, to the United States Food and Drug Administration, or the FDA. In August 2020, the FDA approved the NDA for OLINVYK and the Company initiated commercial launch of OLINVYK in the first quarter of 2021. Since the Company’s inception, the Company has incurred losses and negative cash flows from operations. At December 31, 2022, the Company had an accumulated deficit of $547.8 million. The Company’s net loss was $53.7 million and $51.6 million for the years ended December 31, 2022 and 2021, respectively. The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements—Going Concern |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Reverse Stock Split On November 9, 2022, the Company filed a Certificate of Amendment to the Company’s Certificate of Incorporation to effect a 1 3.05 All of the share and per share amounts discussed in the accompanying consolidated financial statements have been adjusted to reflect the effect of this reverse split. Principles of Consolidation In connection with the loan agreement disclosed in Note 7, the Company established three wholly owned subsidiaries, Trevena Royalty Corporation, Trevena SPV1 LLC and Trevena SPV2 LLC to facilitate the financing. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries as of December 31, 2022. All intercompany accounts and transactions have been eliminated in consolidation. 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. Management used significant estimates in the following areas, among others: stock-based compensation expense, the determination of the fair value of stock-based awards, the fair value of common stock warrants, the accounting for research and development costs, accrued expenses, the recoverability of the Company’s net deferred tax assets and related valuation allowance, and the amortization of the debt expenses. The financial data and other information disclosed in these notes are not necessarily indicative of the results to be expected for any future year or period. The Company bases its estimates on historical experience and also on assumptions that it believes are reasonable, however, actual results could significantly differ from those results. Cash and Cash Equivalents The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents are valued at cost, which approximates their fair market value. The Company maintains a portion of its cash and cash equivalent balances in money market mutual funds that may invest substantially all of their assets in U.S. government agency securities and U.S. Treasury securities. Restricted Cash The Company maintains $0.6 million as collateral under a letter of credit for the Company’s facility lease obligations in Chesterbrook, Pennsylvania. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its balance sheet. In April 2022, the Company placed $2.0 million into an interest reserve account in connection with the royalty based loan agreement (the “Loan Agreement”) with R-Bridge Investment Four Pte. Ltd. (“R-Bridge”). Payments of interest under the Loan Agreement are made quarterly from certain royalties on the Company’s net sales of OLINVYK in the United States and proceeds from royalties from the Company’s license agreement with Jiangsu Nhwa Pharmaceuticals Co. Ltd., or Nhwa. On each interest payment date, if the royalty payments received do not equal the total interest due for the respective quarter, the interest payment due will be paid from the interest reserve account. As of December 31, 2022, the interest reserve account balance is $1.4 million which has been classified as restricted cash in the Company’s consolidated balance sheet. Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, restricted cash, accounts payable and accrued expenses approximate their fair values, given their short-term nature. Additionally, the Company believes the carrying value of the loan payable approximates its fair value as the interest rate is reflective of the rate the Company could obtain on debt with similar terms and conditions. Certain of the Company’s common stock warrants are carried at fair value, as disclosed in Note 3. The Company has evaluated the estimated fair value of financial instruments using available market information and management’s estimates. The use of different market assumptions and/or estimation methodologies could have a significant effect on the estimated fair value amounts. See Note 3 for additional information. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents, and restricted cash. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has no off-balance sheet concentrations of credit risk such as foreign currency exchange contracts, option contracts or other hedging arrangements. Property and Equipment Property and equipment consists of computer and laboratory equipment, software, office equipment, furniture, manufacturing equipment and leasehold improvements and is recorded at cost. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred. Upon disposal, retirement or sale, the related cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations. Property and equipment are depreciated on a straight-line basis over their estimated useful lives. The Company uses a life of three years for computer equipment and five years for laboratory equipment, office equipment, furniture, manufacturing equipment and software. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset. The Company reviews long-lived assets when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the book values of the assets to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the projected discounted future net cash flows arising from the assets. No impairment losses were recorded during the years ended December 31, 2022 or 2021. Leases At the commencement of a lease, the Company recognizes a liability to make lease payments and an asset representing the right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term, including variable fees that are known or subject to a minimum floor. The lease liability includes lease component fees, while non-lease component fees are expensed as incurred for all asset classes. When a contract excludes an implicit rate, the Company utilizes an incremental borrowing rate based on information available at the lease commencement date including lease term and geographic region. The initial valuation of the right-of-use, or ROU, asset includes the initial measurement of the lease liability, lease payments made in advance of the lease commencement date, and initial direct costs incurred by the Company and excludes lease incentives. Leases with an initial term of 12 months or less are classified as short-term leases and are not recorded on the balance sheet. The lease expense for short-term leases is recognized on a straight-line basis over the lease term. The Company tests for impairment of the ROU assets whenever circumstances indicate that the carrying amount of the asset may not be recoverable. Common Stock Warrants Freestanding warrants that are related to the purchase of common stock are classified as liabilities and recorded at fair value regardless of the timing of the redemption feature or the redemption price or the likelihood of redemption. These warrants are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the statements of operations and comprehensive loss. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrants. The warrants are classified as Level 3 liabilities as of December 31, 2022 and 2021. In addition, in connection with entering into loan agreements, the Company has issued warrants to purchase shares of the Company’s common stock. These detachable warrant instruments qualify for equity classification and have been allocated upon the relative fair value of the base instrument and the warrant. See Note 7 and Note 8 for additional information. Revenue In accordance with FASB’s ASC 606, Revenue from Contracts with Customers, or ASC 606, the Company recognizes revenue when customers obtain 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. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: (i) (ii) (iii) (iv) (v) The Company applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. See Note 9 and Note 10, respectively, for a full discussion of the Company’s product revenue and license revenue. Research and Development Research and development costs are charged to expense as incurred. Research and development costs include, but are not limited to, personnel expenses, clinical trial supplies, fees for clinical trial services, manufacturing costs, consulting costs, and allocated overhead. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company may account for these expenses according to the progress of the trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2022 and 2021, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Stock-Based Compensation The Company has equity incentive plans under which various types of equity-based awards including, but not limited to, incentive stock options, non-qualified stock options, and restricted stock unit awards, may be granted to employees, non-employee directors, and non-employee consultants. At December 31, 2022, the Company had two stock-based compensation plans, which are more fully described in Note 8. The Company also has an inducement plan under which various types of equity-based awards, including non-qualified stock options and restricted stock awards, may be granted to new employees. The Company has applied the fair value recognition provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation — Stock Compensation, to account for stock-based compensation for employees. The Company recognizes compensation expense for all stock-based awards based on the estimated grant-date fair values. For restricted stock unit awards to employees, the fair value is based on the closing price of the Company’s common stock on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends and has no current intention of paying cash dividends. The Company elected an accounting policy to record forfeitures as they occur. For stock awards that vest based on performance conditions (e.g., achievement of certain milestones), expense is recognized when it is probable that the conditions will be met. See Note 8 for a discussion of the assumptions used by the Company in determining the grant date fair value of options granted under the Black-Scholes option pricing model, as well as a summary of the stock option activity under the Company’s stock-based compensation plan for all years presented. Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not taken any uncertain tax position or recorded any reserves, interest or penalties. Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Basic and Diluted Net Loss Per Share of Common Stock The Company’s basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per common share is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for all periods presented. Recently Adopted Accounting Standards In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20), to address the complexity associated with applying GAAP to certain financial instruments with characteristics of liabilities and equity, which the Company adopted on January 1, 2022. ASU 2020-06 eliminated the beneficial conversion (and cash conversion) accounting models in ASC 470-20 that require separate accounting for embedded conversion features, and simplified the settlement assessment to determine whether it qualifies for equity classification. In addition, the new guidance requires entities to use the if-converted method to calculate earnings per share for all convertible instruments and to include the effect of share settlement for instruments that may be settled in cash or shares. The Company adopted ASU 2020-06 using the modified retrospective approach and applied the guidance to all financial instruments that were outstanding as of the beginning of 2022. As the Company had not previously separated any financial instruments under the beneficial conversion or cash conversion accounting models, there was no cumulative effect adjustment to the opening balance of retained earnings as a result of adopting ASU 2020-06. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments ASC Topic 820, Fair Value Measurement, ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following: Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. 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 following table presents the Company’s cash, cash equivalents, restricted cash, and warrant liability as of December 31, 2022 and 2021 (in thousands): December 31, Quoted Prices in Active Markets Significant Other Observable Inputs Unobservable Inputs Description: 2022 (Level 1) (Level 2) (Level 3) Assets: Cash $ 9,651 $ 9,651 $ — $ — Money Market Funds 28,669 28,669 — — Restricted Cash 1,960 1,960 — — Total assets measured and recorded at fair value $ 40,280 $ 40,280 $ — $ — Liabilities: Warrant Liability — — — 5,483 Total liabilities measured and recorded at fair value $ — $ — $ — $ 5,483 December 31, Quoted Prices in Active Markets Significant Other Observable Inputs Unobservable Inputs Description: 2021 (Level 1) (Level 2) (Level 3) Assets: — Cash $ 8,148 $ — $ — $ — Money Market Funds 58,775 — — — Restricted Cash 1,311 — — — Total assets measured and recorded at fair value $ 68,234 $ — $ — $ — Liabilities: Warrant Liability — — — — Total liabilities measured and recorded at fair value $ — $ — $ — $ — (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. The Company did not transfer any financial instruments into or out of Level 3 classification, during the year ended December 31, 2022 and 2021. There were no Level 3 financial instruments outstanding as of and for the year ended December 31, 2021. The common stock warrants issued in connection with the Company’s equity raises in July 2022 and November 2022 were classified as liabilities at the time of issuance due to certain cash settlement adjustment features that were not deemed to be indexed to the Company’s stock. The warrant liability is remeasured each reporting period with the change in fair value recorded to other income (expense) in the consolidated statement of operations and comprehensive loss until the warrants are exercised, expired, reclassified or otherwise settled. The fair value of the prefunded warrant liability is equal to its intrinsic value due to the nominal exercise price. The fair value of the warrant liability was estimated using a Black-Scholes Option Pricing Model. The significant assumptions used in preparing the option pricing model for valuing the Company's warrants to purchase shares of common stock included (i) volatility of 106.4 %, (ii) risk free interest rate 4.0% , (iii) strike price ( $0.263 - $2.95 ) per share, (iv) fair value of the Company’s common stock at the time of issuance and again at each reporting period, and (v) expected life of 4.9 years. The Company classifies investments available to fund current operations as current assets on its balance sheets. As of December 31, 2022 and 2021, the Company did not hold any investment securities exceeding a one-year maturity. Accretion of bond discount on marketable securities is included in other income as a separate component of other income (expense) on the statement of operations and comprehensive loss. Interest income on marketable securities is recorded as interest income on the statement of operations and comprehensive loss. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers between Level 2 and Level 3 during the years ended December 31, 2022 or 2021. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2022 | |
Inventories | |
Inventories | 4. Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method for all inventories. Inventory includes the cost of API, raw materials and third-party contract manufacturing and packaging services. Indirect overhead costs associated with production and distribution are recorded as period costs in the period incurred. OLINVYK was approved by the FDA in August 2020. Prior to FDA approval, all manufacturing costs for OLINVYK were expensed to research and development. Upon FDA approval, manufacturing costs for OLINVYK manufactured for commercial sale have been capitalized as inventory cost. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense. The Company periodically evaluates the carrying value of inventory on hand using the same lower of cost or net realizable value approach as that used to initially value the inventory. Valuation adjustments may be required for slow-moving or obsolete inventory or in any situations where market conditions have caused net realizable value to fall below the carrying cost of the inventory. December 31, 2022 December 31, 2021 Finished goods $ 3,111 $ 2,488 Inventory Valuation Adjustment (2,205) (136) Total Inventories $ 906 $ 2,352 The Company recorded an inventory valuation adjustment of $2.1 million during the year ended December 31, 2022 and $0.1 million during the year ended December 31, 2021. The valuation adjustments recorded during the year ended December 31, 2022 were to account for slow moving or obsolete inventory due to uncertainty of commercial activities and future expected OLINVYK sales. The inventory adjustment recorded during the year ended December 31, 2021 was primarily related to a commercial batch that was not saleable based on the Company’s quality requirements. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2022 | |
Property and Equipment, net | |
Property and Equipment, net | 5. Property and Equipment, net Property and equipment consisted of the following (in thousands): Estimated Useful December 31, Life in Years 2022 2021 Computers and software 3 - 5 $ 408 $ 476 Office equipment and furniture 5 721 721 Manufacturing equipment 5 10 10 Leasehold improvements 10 3,082 3,082 Leased assets 5 29 45 Total property and equipment 4,250 4,334 Less accumulated depreciation and amortization (2,762) (2,493) Property and equipment, net $ 1,488 $ 1,841 Depreciation and amortization expense was $0.4 for the years ended December 31, 2022 and 2021. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2022 2021 Compensation and benefits $ 1,965 $ 2,132 Commercial expenses 93 107 Legal expenses 381 124 Clinical trial expenses 1,421 550 Pharmaceutical development expenses 201 161 Credit balances due to customers 67 87 Accrued purchases — 271 Accrued interest 522 — Other accrued expenses and other current liabilities 811 415 Total accrued expenses and other current liabilities $ 5,461 $ 3,847 |
Loan Payable
Loan Payable | 12 Months Ended |
Dec. 31, 2022 | |
Loan Payable. | |
Loan Payable | 7. Loan Payable In April 2022, the Company, through its wholly-owned subsidiary Trevena SPV2 LLC, entered into the Loan Agreement with R-Bridge, pursuant to which the Company may be eligible to receive up to $40.0 million in term loan borrowings, or the R-Bridge Financing. Term loan borrowings will be advanced in three tranches. The first tranche of $15.0 million was advanced in April 2022. The second tranche of $10.0 million will become available upon achievement of either a commercial or financing milestone as set forth in the Loan Agreement. The third tranche of $15.0 million will become available upon the first commercial sale of OLINVYK in China. The following table summarizes the impact of the Loan Agreement on the Company’s consolidated balance sheet as follows (in thousands): December 31, 2022 Principal $ 15,000 Unamortized debt discount (1,570) Loans payable, net 13,430 Current portion of loans payable, net — Carrying Value $ 13,430 The term loans bear interest at a rate per annum equal to 7.00% and will mature on the earlier of (i) the fifteen In April 2022, the Company placed $2.0 million into an interest reserve account in connection with the Loan Agreement. Payments of interest under the Loan Agreement are made quarterly from the royalty on the Company’s net sales of OLINVYK in the United States and proceeds from royalties from the Company’s license agreement with Nhwa. On each interest payment date, if the royalty payments received do not equal the total interest due for the respective quarter, the interest payment due will be paid from the interest reserve account. This interest reserve account is classified as restricted cash in the Company’s consolidated balance sheet at December 31, 2022. Repayments of all borrowings, interest and other related payments, under the Loan Agreement are guaranteed by the Company and secured by substantially all of the assets associated with the license agreement with Nhwa, the Chinese intellectual property related to OLINVYK, and deposit accounts established to hold amounts received on account for repayment of the borrowings and related interest under the Loan Agreement. The Loan Agreement contains certain customary affirmative and negative covenants and contains customary defined events of default, upon which any outstanding principal and unpaid interest shall be due on demand. At December 31, 2022, there were no events of default pursuant to the Loan Agreement and the Company was in compliance with all covenants. Interest expense is imputed based on the estimated loan repayment period, which takes into consideration the probability and timing of obtaining regulatory approval in China and the potential future revenue in the United States and China. Changes in estimates are recognized prospectively and may have a material impact on liability balance. As of December 31, 2022, the effective interest rate was 9%. In connection with the first tranche borrowings in April 2022, the Company issued a warrant to R-Bridge to purchase 200,000 shares of the Company’s common stock at an initial exercise price of $20.50 per share and that is exercisable for three years. The Company concluded the warrant was a freestanding equity-classified instrument to which the proceeds from the first tranche was allocated across the debt and warrant on a relative fair value basis. In addition, the Company incurred lender fees and third-party costs of $0.5 million each and were netted against the proceeds allocated to the debt and warrant. Fees netted against debt proceeds represent a debt discount and are amortized into interest expense using the effective interest method. During the twelve months ended December 31, 2022, the Company recognized interest expense of $1.3 milion, of which $0.1 million pertained to the amortization of the debt discount. The accounting for the Loan Agreement requires the Company to make certain estimates and assumptions, particularly about future royalties under the license agreement with Nhwa and sales of OLINVYK in the United States and China. Such estimates and assumptions are utilized in determining the expected repayment term, amortization period of the debt discount, accretion of interest expense and classification between current and long-term portions of amounts outstanding. The Company amortizes the debt discount into interest expense over the expected term of the arrangement using the interest method based on projected cash flows. Similarly, the Company classifies as current debt for the Loan Agreement, amounts that are expected to be repaid during the succeeding twelve months after the reporting period end. However, the repayment of amounts due under the Loan Agreement is variable because the cash flows to be utilized for periodic payments is a function of amounts received by the Company with respect to the royalties and net product sales. Accordingly, the estimates of the magnitude and timing of amounts to be available for debt service are subject to significant variability and thus, subject to significant uncertainty. Therefore, these estimates and assumptions are likely to change, which may result in future adjustments to the portion of the debt that is classified as a current liability, the amortization of debt discount and the accretion of interest expense. Other amounts that may become due and payable under the Loan Agreement, including amounts shared between the parties with respect to cash flows received in excess of pre-defined thresholds, are recognized as additional interest expense when they become probable and estimable. The amount of principal to be repaid in each of the five succeeding years is not fixed and determinable. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | 8. Stockholders’ Equity Under its Certificate of Incorporation, the Company was authorized to issue up to 200,000,000 shares of common stock as of December 31, 2022 and December 31, 2021. The Company also was authorized to issue up to 5,000,000 shares of preferred stock as of December 31, 2022 and December 31, 2021. The Company is required, at all times, to reserve and keep available out of its authorized but unissued shares of common stock sufficient shares to effect the conversion of the shares of the preferred stock and all outstanding stock options and warrants. ATM Programs On April 17, 2019, the Company entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC, or Wainwright, pursuant to which the Company may offer and sell through Wainwright, from time to time at the Company’s sole discretion, shares of its common stock, having an aggregate offering price of up to $50.0 million, or the HCW ATM Program. Sales of the shares of common stock are deemed to be “at-the-market offerings,” as defined in Rule 415 under the Securities Act. In December 2020, the Company and Wainwright entered into Amendment No. 1 to Common Stock Sales Agreement, or the Amendment, to amend the Common Stock Sales Agreement to, among other things, update the reference to the registration statement pursuant to which the shares of common stock may be sold and to include an additional $50.0 million of shares of common stock in the HCW ATM Program. There were no shares issued under the HCW ATM program during the year ended December 31, 2022. As of December 31, 2022, there was approximately $41.9 million remaining available for future issuances under the HCW ATM Program. Registered Direct Offerings and Concurrent Warrant Issuances In July 2022, the Company announced a targeted registered direct financing of 72 shares of the Company’s Series A convertible preferred stock, or the Series A Preferred, and 8 shares of the Company’s Series B convertible preferred stock, or Series B Preferred. The shares of preferred stock issued in this offering are convertible into an aggregate of In connection with this registered direct offering, the Company also issued warrants to purchase 320,000 shares of common stock (each, a “Common Stock Warrant”) (together with the Series A Preferred and Series B Preferred, the “Preferred Stock Transaction”). The Common Stock Warrants have an exercise price of $6.575 per share, will be exercisable beginning on the later of six months following the date of issuance and the effective date of a reverse stock split of our common stock in an amount sufficient to permit the exercise in full of the Common Stock Warrants and will expire five The net proceeds from the Common Stock Warrant liability $ 1,519 Series A and Series B Preferred Stock 481 Gross Proceeds $ 2,000 The net proceeds related to the Preferred Stock Transaction were approximately $1.6 million. Approximately million of issuance costs were incurred and allocated on a pro rata basis to the Common Stock Warrant liability and the Series A and Series B Preferred Stock, respectively. Approximately million was allocated to the Common Stock Warrant liability and recorded in selling, general and administrative expenses. The Series A and Series B Preferred Stock were recorded net of approximately The fair value of the Common Stock Warrant liability was determined using Level 3 inputs and was estimated using the Black-Scholes valuation model. The assumptions used to estimate the fair value were as follows: July 29, December 31, 2022 2022 Expected term of warrants (in years) 5.0 4.6 Risk-free interest rate 2.7 % 4.0 % Expected volatility 104.3 % 108.9 % Dividend yield — % — % The following is a roll forward of the Common Stock Warrant liability from date of issuance to December 31, 2022: Date of issuance, July 29, 2022 $ 1,519 Change in fair value (1,260) Balance, December 31, 2022 $ 259 November 2022 Equity Offering and Warrant issuance In November 2022, the Company completed a registered direct offering with a single institutional investor whereby the Company sold (i) 765,000 shares of common stock, (ii) pre-funded warrants to purchase 1,849,380 shares of common stock with an exercise price of $0.001 per share and (iii) warrants to purchase an aggregate of 2,614,380 shares of common stock at an initial exercise price of $2.95 per share. The warrants are exercisable immediately on the date of issuance and will expire five years after the date of issuance. The pre-funded warrants are exercisable immediately on the date of issuance and will remain outstanding until this warrant is exercised in full. The Company received $7.6 million in net cash proceeds after deducting underwriter fees and other third-party costs. The pre-funded warrants and warrants are liability classified as they contain certain cash settlement adjustment features that were outside of the Company’s control or not deemed to be indexed to the Company’s stock, respectively. Due to the nominal exercise price of the prefunded warrants, the fair value is equal to the intrinsitc value. The fair value of the Common Stock Warrant liability was determined using Level 3 inputs and was estimated using the Black-Scholes valuation model. The assumptions used to estimate the fair value were as follows: November 18, 2022 December 31, 2022 Expected term of warrants (in years) 5.0 4.9 Risk-free interest rate 4.0 % 4.0 % Expected volatility 104.5 % 106.1 % Dividend yield — % — % The following is a roll forward of the Common Stock Warrant liability from date of issuance to December 31, 2022: Warrant Liability Date of Issuance, November 18 $ 15,144 Change in fair value (9,920) Balance, December 31, 2021 $ 5,224 Warrants As of December 31, 2022, the Company had the following common stock warrants outstanding: Classification Outstanding, December 31, 2021 Granted Cancelled/Expired Outstanding, December 31, 2022 Exercise Price Per Share Expiration Date July 2022 Offering Liability — 320,000 — 320,000 $6.58 12/28/2027 November 2022 Offering Liability — 1,849,380 — 1,849,380 0.001 Until exercised November 2022 Offering Liability — 2,614,380 — 2,614,380 2.95 11/18/2027 R-Bridge warrants Equity — 200,000 — 200,000 20.50 4/14/2025 Other warrants Equity 11,014 — — 11,014 31.25 - 265.48 1/29/24 - 3/31/27 11,014 4,983,760 — 4,994,774 Equity Incentive Plans In 2008, the Company adopted the 2008 Equity Incentive Plan, as amended on February 29, 2008, January 7, 2010, July 8, 2010, December 10, 2010, June 23, 2011 and June 17, 2013, collectively, the 2008 Plan, that authorized the Company to grant restricted stock and stock options to eligible employees, directors and consultants to the Company. In 2013, the Company adopted the 2013 Equity Incentive Plan, as amended on May 14, 2014, collectively, 2013 Plan. The 2013 Plan became effective upon the Company’s entry into the underwriting agreement related to its IPO in January 2014 and, as of such date, no further grants were permitted under the 2008 Plan. The 2013 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards and other forms of equity compensation (collectively, stock awards), all of which may be granted to employees, including officers, non-employee directors and consultants of the Company. Additionally, the 2013 Plan provides for the grant of cash and stock-based performance awards. The 2013 Plan contains an “evergreen” provision, pursuant to which the number of shares of common stock available for issuance under the plan automatically increases on January 1 of each year beginning in 2015. On December 15, 2016, the Company adopted the Trevena, Inc. Inducement Plan, or the Inducement Plan, effective January 1, 2017, pursuant to which the Company reserved 20,000 shares of the Company’s common stock for issuance under the Inducement Plan. The Plan provides for nonqualified stock options and restricted stock unit awards. The only persons eligible to receive grants of awards under the Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq Marketplace Rule 5635(c)(4) and the related guidance under Nasdaq IM 5635-1, including individuals who were not previously an employee or director of the Company or are following a bona fide period of non-employment, in each case as an inducement material to such individual’s agreement to enter into employment with the Company. Under all Plans, the amount, terms of grants and exercisability provisions are determined by the board of directors or its designee. The term of the options may be up to 10 years, and options are exercisable in cash or as otherwise determined by the board of directors or its designee. Vesting generally occurs over a period of not greater than four years. For performance-based stock awards, the Company recognizes expense when achievement of the performance condition is probable, over the requisite service period. The estimated grant-date fair value of the Company’s stock-based awards is amortized on a straight-line basis over the awards’ service periods. Stock-based compensation expense recognized was as follows (in thousands): Year Ended December 31, 2022 2021 Research and development $ 806 $ 1,066 Selling, general and administrative 2,871 3,303 Cost of goods sold (1) 38 Total stock-based compensation $ 3,676 $ 4,407 Stock Options A summary of stock option activity and related information from January 1, 2021 through December 31, 2022 follows: Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, January 1, 2021 382,561 $ 76.85 7.17 Granted 149,905 39.91 Exercised (5,861) 32.10 Forfeited/Cancelled (28,628) 70.20 Balance, December 31, 2021 497,977 $ 66.64 7.11 Granted 39,998 11.47 Exercised — — Forfeited/Cancelled (186,266) 87.83 Balance, December 31, 2022 351,709 $ 49.15 6.94 Vested or expected to vest at December 31, 2022 351,709 $ 49.15 6.94 Exercisable at December 31, 2022 228,409 $ 56.82 6.15 The aggregate intrinsic value of the options exercisable as of December 31, 2022 was zero, based on the difference between the Company’s closing stock price of $1.43 and the exercise price of each stock option. The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock options at the grant date. The Black-Scholes model requires the Company to make certain estimates and assumptions, including estimating the fair value of the Company’s common stock, assumptions related to the expected price volatility of the Company’s stock, the period during which the options will be outstanding, the rate of return on risk-free investments and the expected dividend yield for the Company’s stock. The per-share weighted average grant date fair value of the options granted to employees and directors during the years ended December 31, 2022 and 2021 was estimated at $8.88 and $31.19 per share, respectively, on the date of grant using the Black-Scholes option-pricing model with the following weighted average assumptions: December 31, 2022 2021 Expected term of options (in years) 5.7 6.2 Risk-free interest rate 2.7 % 1.0 % Expected volatility 98.0 % 98.0 % Dividend yield — % — % The weighted average valuation assumptions were determined as follows: ● Risk-free interest rate: The Company based the risk-free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term. ● Expected term of options: Due to its lack of sufficient historical data, the Company estimates the expected life of its employee stock options using the “simplified” method, as prescribed in Staff Accounting Bulletin No. 107. ● Expected stock price volatility: The Company estimates the expected volatility based on the actual historical volatility of the Company’s stock price using daily closing prices over a period equal to the expected term of the associated award. ● Expected annual dividend yield: The Company estimated the expected dividend yield based on consideration of its historical dividend experience and future dividend expectations. The Company has not historically declared or paid dividends to stockholders. Moreover, it does not intend to pay dividends in the future, but instead expects to retain any earnings to invest in the continued growth of the business. Accordingly, the Company assumed an expected dividend yield of 0.0% . The Company elects to record forfeitures upon occurrence, rather than utilizing an estimate. As of December 31, 2022, there was $2.9 million of total unrecognized compensation expense related to unvested stock options that will be recognized over the weighted average remaining period of 2.06 years. Restricted Stock Units RSU-related expense is recognized on a straight-line basis over the vesting period. Upon vesting, these awards may be settled on a net-exercise basis to cover any required withholding tax with the remaining amount converted into an equivalent number of shares of common stock. There were 14,201 shares of common stock withheld for employee teaxes as a result of the vested RSUs during the year ended December 31, 2022 whose value was based on the Company’s closing stock price on the applicable vesting date. The shares withheld for taxes are again available for issuance under the plan. The following is a summary of changes in the status of non-vested RSUs from January 1, 2021 through December 31, 2022: Weighted Average Number of Grant Date Awards Fair Value Non-vested at January 1, 2021 150,849 41.59 Granted 174,332 17.50 Vested (62,460) 30.05 Forfeited/Cancelled (25,984) 40.96 Non-vested at December 31, 2021 236,737 26.97 Granted 233,987 1.83 Vested (55,800) 27.19 Forfeited (48,147) 30.55 Non-vested at December 31, 2022 366,777 $ 10.43 For the years ended December 31, 2022 and 2021, the Company recorded $1.5 million and $1.8 million, respectively, in stock-based compensation expense related to RSUs, which is reflected in the statements of operations and comprehensive loss. As of December 31, 2022, there was $3.7 million of total unrecognized compensation expense related to unvested RSUs that will be recognized over the weighted average remaining period of 2.62 years. Shares Available for Future Grant At December 31, 2022, the Company has the following shares available to be granted: Inducement 2013 Plan Plan Available at December 31, 2021 167,246 10,100 Authorized 264,832 — Granted (273,985) — Shares withheld for taxes not issued 14,201 — Forfeited/Cancelled 232,513 1,900 Available at December 31, 2022 404,807 12,000 Shares Reserved for Future Issuance At December 31, 2022, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 343,709 Restricted stock units outstanding under 2013 Plan 366,777 Stock options outstanding under Inducement Plan 8,000 Shares reserved for future issuance under Inducement Plan 12,000 Shares reserved for future issuance under 2013 Employee Stock Purchase Plan 9,032 Warrants outstanding 4,994,774 Total shares of common stock reserved for future issuance 5,734,292 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 9. Commitments and Contingencies Leases The Company leases office space in Chesterbrook, Pennsylvania and equipment. The Company’s principal office is located at 955 Chesterbrook Boulevard, Chesterbrook, Pennsylvania, where the Company currently leases approximately 8,231 square feet of developed office space on the first floor and 40,565 square feet of developed office space on the second floor. The lease term for this space extends through May 2028. On October 11, 2018, the Company entered into an agreement with The Vanguard Group, Inc., or Vanguard, whereby Vanguard agreed to sublease the 40,565 square feet of space on the second floor for an initial term of 37 months. On October 2, 2020, Vanguard notified the Company that they exercised the first option to extend the sublease term for three years through November 30, 2024. Vanguard has a second option to extend the sublease term for an additional three years through November 30, 2027. The sublease provides for rent abatement for the first month of the term; thereafter, the rent payable to the Company by Vanguard under the sublease is (i) $0.50 less during months 2 through 13 of the sublease and (ii) in month 14 and thereafter of the sublease, $1.00 less than the base rent payable by the Company under its master lease with Chesterbrook Partners, L.P. Vanguard also is responsible for paying to the Company all tenant energy costs, annual operating costs, and annual tax costs attributable to the subleased space during the term of the sublease. Rent expense and associated sublease income are recorded in the Company’s statements of operations and comprehensive loss as other income (expense). Supplemental balance sheet information related to leases was as follows (in thousands): December 31, 2022 December 31, 2021 Operating leases: Operating lease right-of-use assets $ 4,224 $ 4,706 Other current lease liabilities 890 788 Operating lease liabilities 5,419 6,309 Total operating lease liabilities $ 6,309 $ 7,097 Finance leases: Property and equipment, at cost $ 29 $ 45 Accumulated depreciation (4) (41) Property and equipment, net 25 4 Other current lease liabilities 9 4 Other long-term liabilities 17 — Total finance lease liabilities $ 26 $ 4 The components of lease expense were as follows (in thousands): Year Ended December 31, 2022 2021 Operating lease costs: Operating lease rental expense $ 1,308 $ 1,228 Other income (1,330) (1,186) Total operating lease costs $ (22) $ 42 Finance lease costs: Amortization of right-of-use assets 7 7 Interest on lease liabilities 1 1 Total finance lease costs $ 8 $ 8 Supplemental cash flow information related to leases was as follows (in thousands): Year Ended December 31, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (295) $ (265) Financing cash flows from finance leases (8) (8) Our lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2023 1,425 11 2024 1,450 11 2025 1,474 7 2026 1,499 — 2027 and beyond 2,163 — Total minimum lease payments $ 8,011 $ 29 Interest Expense (1,702) (3) Lease liability $ 6,309 $ 26 Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2023 1,139 2024 995 2025 — 2026 — 2027 and beyond — Total minimum lease payments $ 2,134 Weighted average lease term and discount rates are as follows: Year Ended December 31, 2022 2021 Weighted average remaining lease term (years) Operating leases 5 6 Finance leases 3 — Weighted average discount rate Operating leases 9.2% 9.2% Finance leases 6.5% 6.5% The Company had of $0.1 million and $0 deferred rent at December 31, 2022 and 2021, respectively, related to its facility leases. |
Product Revenue
Product Revenue | 12 Months Ended |
Dec. 31, 2022 | |
Product Revenue. | |
Product Revenue | 10. Product Revenue Performance Obligation The Company’s performance obligation is the supply of finished pharmaceutical products to its customers. The Company’s customers consist of major wholesale distributors. The Company’s customer contracts generally consist of both a master agreement, which is signed by the Company and its customer, and a customer submitted purchase order, which is governed by the terms and conditions of the master agreement. Revenue is recognized when the Company transfers control of its products to the customer, which occurs at a point-in-time, upon delivery. The Company offers standard payment terms to its customers and has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing, since the period between when the Company transfers the product to the customer and when the customer pays for that product is one year or less. Taxes collected from customers relating to product revenue and remitted to governmental authorities are excluded from revenues. The consideration amounts due from customers as a result of product revenue are subject to variable consideration. The Company offers standard product warranties which provide assurance that the product will function as expected and in accordance with specifications. Customers cannot purchase warranties separately and these warranties do not give rise to a separate performance obligation. The Company permits the return of product under certain circumstances, mainly upon at or near product expiration, instances of shipping errors or where product is damaged in transit. The Company accrues for the customer’s right to return as part of its variable consideration. See below for further details. Variable Consideration The Company includes an estimate of variable consideration in its transaction price at the time of sale when control of the product transfers to the customer. Variable consideration includes distributor chargebacks, prompt payment (cash) discounts, distribution service fees and product returns. The Company assesses whether or not an estimate of its variable consideration is constrained and has determined that the constraint does not apply, since it is probable that a significant reversal in the amount of cumulative revenue will not occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. The Company’s estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result in a change in the amount of total consideration it expects to receive. Distributor Chargebacks When a product that is subject to a contractual price agreement is sold to a third party, the difference between the price paid to the Company by the wholesaler and the price under the specific contract is charged back to the Company by the wholesaler. Utilizing this information, the Company estimates a chargeback percentage for each product and records an allowance for chargebacks as a reduction to revenue when the Company records sales of the products. We reduce the chargeback allowance when a chargeback request from a wholesaler is processed. Reserves for distributor chargebacks are included in accounts receivable, net on the consolidated balance sheet. Prompt Payment (Cash) Discounts The Company provides customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The Company’s prompt payment discount reserves are based on actual net sales and contractual discount rates. Reserves for prompt payment discounts are included in accounts receivable, net on the consolidated balance sheet. Distribution Service Fees The Company pays distribution service fees to its customers based on a fixed percentage of the product price. These fees are not in exchange for a distinct good or service and therefore are recognized as a reduction of the transaction price. The Company reserves for these fees based on actual net sales, contractual fee rates negotiated with the customer and the mix of the products in the distribution channel that remain subject to fees. Reserves for distribution service fees are included in accounts receivable, net on the consolidated balance sheet. Product Returns Generally, the Company’s customers have the right to return any unopened product during the eighteen 18 six 6 twelve 12 Six 6 longer period of time (i.e., two forty-eight 48 The Company recognizes the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since the returns primarily consist of expired and short dated products that will not be resold, the Company does not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due to the anticipated return). Accrued product return estimates are recorded in accrued expenses and other current liabilities on the consolidated balance sheet. Concentration of Revenue The Company’s three customers account for 100% of total product revenue for the year ended December 31, 2021. Sales-Related Deductions The following table presents a rollforward of the major categories of sales-related deductions included in trade receivable allowances for the year ended December 31, 2022 (in thousands): Sales Discounts Chargebacks Fee for Service Balance, January 1, 2022 $ 1 $ 41 $ 45 Adjustment related to prior period sales — (11) (9) Balance, December 31, 2022 $ 1 $ 30 $ 36 As of December 31, 2022, the Company has $19,000 of outstanding accounts receivable and, as a result, the portion of the trade allowance in excess of accounts receivable of $67,000 has been included with accrued expenses and other current liabilities on the Company’s balance sheet. The company also recorded a $0.4 million returns reserve adjustment from OLINVYK during the year ended December 31, 2022. The adjustment was recorded to account for expected returns from our wholesalers. |
License Revenue
License Revenue | 12 Months Ended |
Dec. 31, 2022 | |
License Revenue. | |
License Revenue | 11. License Revenue License and Commercialization Agreement with Pharmbio Korea Inc. In April 2018, the Company entered into an exclusive license agreement with Pharmbio Korea Inc., or Pharmbio, for the development and commercialization of OLINVYK for the management of moderate to severe acute pain in South Korea. Under the terms of the agreement, the Company received an upfront, non-refundable cash payment of $3.0 million (less applicable withholding taxes of $0.5 million) in June 2018, and will receive a cash commercial milestone of up to $0.5 million if OLINVYK is approved in South Korea and tiered royalties on product sales in South Korea ranging from high single digits to 20%, less applicable withholding taxes. As part of the agreement, the Company also granted Pharmbio an option to manufacture OLINVYK, on a non-exclusive basis, for the development and commercialization of the product in South Korea, subject to a separate arrangement to be entered into if Pharmbio exercises the option. The license agreement is terminable by Pharmbio for any reason upon 180 days written notice. In accordance with the terms of the agreement, Pharmbio is solely responsible for all development and regulatory activities in South Korea. The parties have formed a Joint Development Committee with equal representation from the Company and Pharmbio to provide overall coordination and oversight of the development of OLINVYK in South Korea. The parties also agreed to form a Joint Manufacturing and Commercialization Committee at least six months prior to the anticipated date of regulatory approval of OLINVYK in South Korea to provide overall coordination and oversight of the manufacture and commercialization of OLINVYK in South Korea. License Agreement with Jiangsu Nhwa Pharmaceutical Co. Ltd. In April 2018, the Company also entered into an exclusive license agreement with Jiangsu Nhwa Pharmaceutical Co. Ltd., or Nhwa, for the development and commercialization of OLINVYK for the management of moderate to severe acute pain in China. Under the terms of this agreement, the Company received an upfront, non-refundable cash payment of $2.5 million (less applicable withholding taxes of $0.3 million) in July 2018. In August 2020, the Company received a milestone payment of $3.0 million (less applicable withholding taxes of $0.3 million), that became payable by Nhwa upon FDA approval of OLINVYK. The Company is also eligible to receive a cash milestone payment of $3.0 million, subject to Chinese withholding taxes, upon regulatory approval of OLINVYK in China, up to an additional $6.0 million of commercialization milestone payments based on product sales levels in China, and a ten percent royalty on all net product sales in China, less applicable withholding taxes. As part of the agreement, the Company also granted Nhwa an option to manufacture OLINVYK, on an exclusive basis in China, for the development and commercialization of the product in China. In the second quarter of 2018, Nhwa elected to exercise this manufacturing option. The license agreement is terminable by Nhwa for any reason upon 180 days written notice. In accordance with the terms of the agreement, Nhwa is solely responsible for all development and regulatory activities in China. The parties have formed a Joint Development Committee with equal representation from the Company and Nhwa to provide overall coordination and oversight of the development of OLINVYK in China. The parties also agreed to form a Joint Manufacturing and Commercialization Committee at least six months prior to the anticipated date of regulatory approval of OLINVYK in China to provide overall coordination and oversight of the manufacture and commercialization of OLINVYK in China. For the year ended December 31, 2022 and 2021, license revenue in the accompanying statements of operations and comprehensive loss is comprised of the following: Year Ended December 31, 2022 2021 Pharmbio Korea Inc. $ 20 $ — Jiangsu Nhwa Pharmaceutical Co. Ltd. — 69 Total license revenues $ 20 $ 69 License revenue recorded for the year ended December 31, 2022 related to materials shipped to PharmBio to support the development of oliceridine efforts in South Korea. License revenue recorded for the year ended December 31, 2021 consisted of $0.1 million related to materials shipping to Nhwa to support the development of oliceridine efforts in China. |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2022 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 12. Net Loss Per Common Share The following table sets forth the computation of basic and diluted net loss per share for the periods indicated (in thousands, except share and per share data): Year Ended December 31, 2022 2021 Basic and diluted net loss per common share calculation: Net loss $ (53,670) $ (51,588) Weighted average common shares outstanding 7,072,362 6,529,074 Net loss per share of common stock - basic and diluted $ (7.59) $ (7.90) The pre-funded warrants to purchase common shares issued in connection with the November 2022 offering are included in the calculation for basic and diluted net loss per share as the exercise price of $0.001 per share is non-substantive and is virtually assure. The pre-funded warrants are more fully described in Note 8. The following outstanding securities at December 31, 2022 and 2021 have been excluded from the computation of diluted weighted shares outstanding, as they would have been anti-dilutive: December 31, 2022 2021 Options outstanding 346,367 481,620 RSUs outstanding 366,777 236,737 Warrants outstanding 3,145,394 11,014 Total 3,858,538 729,371 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Income Taxes | 13. Income Taxes The income tax provision for the years ended December 31, 2022 and 2021 are as follows (in thousands): December 31, 2022 2021 Current: State $ — $ — Federal — — Foreign — — Total — — Deferred State — — Federal — — Foreign — — Total — — Total income tax provision (benefit) $ — $ — Deferred tax assets and liabilities reflect the net effects of net operating losses, or NOLs, and tax credit carryovers and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Realization of the deferred tax assets is contingent on future taxable income and based upon the level of historical losses, management has concluded that the deferred tax assets do not meet the more-likely-than-not threshold for realizability. Accordingly, a full valuation allowance continues to be recorded against the Company's deferred tax assets as of December 31, 2022 and 2021. The Company’s valuation allowance decreased by $7.5 million and increased $14.4 million for the years ended December 31, 2022 and 2021, respectively. Significant components of the Company’s net deferred tax assets as of December 31, 2022 and 2021 are as follows (in thousands): December 31, 2022 2021 Deferred tax assets: NOLs $ 46,490 $ 40,810 Research and development credits 16,309 15,575 Research and development expenses capitalized for tax purposes 80,648 93,254 Equity-based compensation 2,257 3,960 Deferred rent 520 691 Depreciation 365 312 Other temporary differences 1,192 657 Total deferred tax assets 147,781 155,259 Deferred tax liabilities: Prepaid expenses (436) (381) Total deferred tax liabilities (436) (381) Net deferred tax assets 147,345 154,878 Less valuation allowance (147,345) (154,878) Net deferred tax asset $ — $ — A reconciliation of income tax expense computed at the statutory federal income tax rate to income taxes as reflected in the financial statements is as follows: December 31, 2022 2021 Percent of pre-tax income: U.S. federal statutory income tax rate 21.0 % 21.0 % Permanent Differences 1.3 % (0.2) % State taxes, net of federal benefit 4.8 % 7.2 % Research and development credit 1.5 % 1.3 % Reduction of state tax rate (37.7) % — % Stock compensation (3.2) % (1.4) % Other (1.7) % 0.1 % Change in valuation allowance 14.0 % (28.0) % Effective income tax rate — % — % As of December 31, 2022, the Company had U.S. federal and state NOLs of $188.7 million and $174.3 million, respectively, that begin to expire starting in 2027. As of December 31, 2022, the Company had federal research and development tax credit carryforwards of $16.3 million that begin to expire in 2027. Net operating loss and tax credit carryforwards may become subject to annual limitations in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined by Sections 382 and 383 of the Internal Revenue Code as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The Tax Cuts and Jobs Act of 2017 (TCJA) amended IRC Section 174 to require capitalization of all research and developmental (R&D) costs incurred in tax years beginning after December 31, 2021. These costs are required to be amortized over five years if the R&D activities are performed in the U.S., or over 15 years if the activities were performed outside the U.S. The Company capitalized approximately $18.7 million of R&D expenses incurred as of December 31, 2022. During 2022, Pennsylvania enacted law that reduces the corporate net income tax rate through a phased in timeline starting in 2023 through each successive year through 2031 from its current 9.99% rate down to 4.99% by 2031. The Company adjusted its deferred tax balances as of December 31, 2022 for the effect of the anticipated tax rates that are phased in during 2023-2031. The total adjustment amounted to a deferred tax expense of $25.7 million which was offset by a full valuation allowance. The Company files income tax returns in the U.S., the Commonwealth of Pennsylvania and various other states. Tax years for 2018 and thereafter are open and potentially subject to examination by the federal and state taxing authorities. The Company is currently not under examination by the Internal Revenue Service or any other jurisdictions for any tax years. To the extent the Company utilizes any tax attributes from a tax period that may otherwise be closed due to statute expiration, the Internal Revenue Service, state tax authorities, or other governing parties may still adjust the tax attributes upon their examination of the future period in which the attribute was utilized. There are no |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2022 | |
Employee Benefit Plan | |
Employee Benefit Plan | 14. Employee Benefit Plan The Company sponsors a 401(k) defined contribution plan for its employees. Employee contributions are voluntary. The Company matches employee contributions in an amount equal to 100% of the first 3% of eligible compensation and 50% of the next 2% of eligible compensation, and such employer contributions are immediately vested. During each of the years ended December 31, 2022 and 2021, the Company provided matching contributions of $0.3 million. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Reverse Stock Split | Reverse Stock Split On November 9, 2022, the Company filed a Certificate of Amendment to the Company’s Certificate of Incorporation to effect a 1 3.05 All of the share and per share amounts discussed in the accompanying consolidated financial statements have been adjusted to reflect the effect of this reverse split. |
Principles of Consolidation | Principles of Consolidation In connection with the loan agreement disclosed in Note 7, the Company established three wholly owned subsidiaries, Trevena Royalty Corporation, Trevena SPV1 LLC and Trevena SPV2 LLC to facilitate the financing. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries as of December 31, 2022. All intercompany accounts and transactions have been eliminated in consolidation. |
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. Management used significant estimates in the following areas, among others: stock-based compensation expense, the determination of the fair value of stock-based awards, the fair value of common stock warrants, the accounting for research and development costs, accrued expenses, the recoverability of the Company’s net deferred tax assets and related valuation allowance, and the amortization of the debt expenses. The financial data and other information disclosed in these notes are not necessarily indicative of the results to be expected for any future year or period. The Company bases its estimates on historical experience and also on assumptions that it believes are reasonable, however, actual results could significantly differ from those results. |
Cash and Cash Equivalents and Marketable Securities | Cash and Cash Equivalents The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents are valued at cost, which approximates their fair market value. The Company maintains a portion of its cash and cash equivalent balances in money market mutual funds that may invest substantially all of their assets in U.S. government agency securities and U.S. Treasury securities. |
Restricted Cash | Restricted Cash The Company maintains $0.6 million as collateral under a letter of credit for the Company’s facility lease obligations in Chesterbrook, Pennsylvania. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its balance sheet. In April 2022, the Company placed $2.0 million into an interest reserve account in connection with the royalty based loan agreement (the “Loan Agreement”) with R-Bridge Investment Four Pte. Ltd. (“R-Bridge”). Payments of interest under the Loan Agreement are made quarterly from certain royalties on the Company’s net sales of OLINVYK in the United States and proceeds from royalties from the Company’s license agreement with Jiangsu Nhwa Pharmaceuticals Co. Ltd., or Nhwa. On each interest payment date, if the royalty payments received do not equal the total interest due for the respective quarter, the interest payment due will be paid from the interest reserve account. As of December 31, 2022, the interest reserve account balance is $1.4 million which has been classified as restricted cash in the Company’s consolidated balance sheet. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, restricted cash, accounts payable and accrued expenses approximate their fair values, given their short-term nature. Additionally, the Company believes the carrying value of the loan payable approximates its fair value as the interest rate is reflective of the rate the Company could obtain on debt with similar terms and conditions. Certain of the Company’s common stock warrants are carried at fair value, as disclosed in Note 3. The Company has evaluated the estimated fair value of financial instruments using available market information and management’s estimates. The use of different market assumptions and/or estimation methodologies could have a significant effect on the estimated fair value amounts. See Note 3 for additional information. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents, and restricted cash. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has no off-balance sheet concentrations of credit risk such as foreign currency exchange contracts, option contracts or other hedging arrangements. |
Property and Equipment | Property and Equipment Property and equipment consists of computer and laboratory equipment, software, office equipment, furniture, manufacturing equipment and leasehold improvements and is recorded at cost. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred. Upon disposal, retirement or sale, the related cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations. Property and equipment are depreciated on a straight-line basis over their estimated useful lives. The Company uses a life of three years for computer equipment and five years for laboratory equipment, office equipment, furniture, manufacturing equipment and software. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset. The Company reviews long-lived assets when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the book values of the assets to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the projected discounted future net cash flows arising from the assets. No impairment losses were recorded during the years ended December 31, 2022 or 2021. |
Leases | Leases At the commencement of a lease, the Company recognizes a liability to make lease payments and an asset representing the right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term, including variable fees that are known or subject to a minimum floor. The lease liability includes lease component fees, while non-lease component fees are expensed as incurred for all asset classes. When a contract excludes an implicit rate, the Company utilizes an incremental borrowing rate based on information available at the lease commencement date including lease term and geographic region. The initial valuation of the right-of-use, or ROU, asset includes the initial measurement of the lease liability, lease payments made in advance of the lease commencement date, and initial direct costs incurred by the Company and excludes lease incentives. Leases with an initial term of 12 months or less are classified as short-term leases and are not recorded on the balance sheet. The lease expense for short-term leases is recognized on a straight-line basis over the lease term. The Company tests for impairment of the ROU assets whenever circumstances indicate that the carrying amount of the asset may not be recoverable. |
Common Stock Warrants | Common Stock Warrants Freestanding warrants that are related to the purchase of common stock are classified as liabilities and recorded at fair value regardless of the timing of the redemption feature or the redemption price or the likelihood of redemption. These warrants are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the statements of operations and comprehensive loss. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrants. The warrants are classified as Level 3 liabilities as of December 31, 2022 and 2021. In addition, in connection with entering into loan agreements, the Company has issued warrants to purchase shares of the Company’s common stock. These detachable warrant instruments qualify for equity classification and have been allocated upon the relative fair value of the base instrument and the warrant. See Note 7 and Note 8 for additional information. |
Revenue | Revenue In accordance with FASB’s ASC 606, Revenue from Contracts with Customers, or ASC 606, the Company recognizes revenue when customers obtain 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. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: (i) (ii) (iii) (iv) (v) The Company applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. See Note 9 and Note 10, respectively, for a full discussion of the Company’s product revenue and license revenue. |
Research and Development | Research and Development Research and development costs are charged to expense as incurred. Research and development costs include, but are not limited to, personnel expenses, clinical trial supplies, fees for clinical trial services, manufacturing costs, consulting costs, and allocated overhead. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company may account for these expenses according to the progress of the trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2022 and 2021, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Stock-Based Compensation | Stock-Based Compensation The Company has equity incentive plans under which various types of equity-based awards including, but not limited to, incentive stock options, non-qualified stock options, and restricted stock unit awards, may be granted to employees, non-employee directors, and non-employee consultants. At December 31, 2022, the Company had two stock-based compensation plans, which are more fully described in Note 8. The Company also has an inducement plan under which various types of equity-based awards, including non-qualified stock options and restricted stock awards, may be granted to new employees. The Company has applied the fair value recognition provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation — Stock Compensation, to account for stock-based compensation for employees. The Company recognizes compensation expense for all stock-based awards based on the estimated grant-date fair values. For restricted stock unit awards to employees, the fair value is based on the closing price of the Company’s common stock on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends and has no current intention of paying cash dividends. The Company elected an accounting policy to record forfeitures as they occur. For stock awards that vest based on performance conditions (e.g., achievement of certain milestones), expense is recognized when it is probable that the conditions will be met. See Note 8 for a discussion of the assumptions used by the Company in determining the grant date fair value of options granted under the Black-Scholes option pricing model, as well as a summary of the stock option activity under the Company’s stock-based compensation plan for all years presented. |
Income Taxes | Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not taken any uncertain tax position or recorded any reserves, interest or penalties. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. |
Basic and Diluted Net Loss Per Share of Common Stock | Basic and Diluted Net Loss Per Share of Common Stock The Company’s basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per common share is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for all periods presented. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20), to address the complexity associated with applying GAAP to certain financial instruments with characteristics of liabilities and equity, which the Company adopted on January 1, 2022. ASU 2020-06 eliminated the beneficial conversion (and cash conversion) accounting models in ASC 470-20 that require separate accounting for embedded conversion features, and simplified the settlement assessment to determine whether it qualifies for equity classification. In addition, the new guidance requires entities to use the if-converted method to calculate earnings per share for all convertible instruments and to include the effect of share settlement for instruments that may be settled in cash or shares. The Company adopted ASU 2020-06 using the modified retrospective approach and applied the guidance to all financial instruments that were outstanding as of the beginning of 2022. As the Company had not previously separated any financial instruments under the beneficial conversion or cash conversion accounting models, there was no cumulative effect adjustment to the opening balance of retained earnings as a result of adopting ASU 2020-06. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value of Financial Instruments | |
Schedule of cash, cash equivalents, marketable securities and restricted cash | The following table presents the Company’s cash, cash equivalents, restricted cash, and warrant liability as of December 31, 2022 and 2021 (in thousands): December 31, Quoted Prices in Active Markets Significant Other Observable Inputs Unobservable Inputs Description: 2022 (Level 1) (Level 2) (Level 3) Assets: Cash $ 9,651 $ 9,651 $ — $ — Money Market Funds 28,669 28,669 — — Restricted Cash 1,960 1,960 — — Total assets measured and recorded at fair value $ 40,280 $ 40,280 $ — $ — Liabilities: Warrant Liability — — — 5,483 Total liabilities measured and recorded at fair value $ — $ — $ — $ 5,483 December 31, Quoted Prices in Active Markets Significant Other Observable Inputs Unobservable Inputs Description: 2021 (Level 1) (Level 2) (Level 3) Assets: — Cash $ 8,148 $ — $ — $ — Money Market Funds 58,775 — — — Restricted Cash 1,311 — — — Total assets measured and recorded at fair value $ 68,234 $ — $ — $ — Liabilities: Warrant Liability — — — — Total liabilities measured and recorded at fair value $ — $ — $ — $ — (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventories | |
Schedule of Inventories | December 31, 2022 December 31, 2021 Finished goods $ 3,111 $ 2,488 Inventory Valuation Adjustment (2,205) (136) Total Inventories $ 906 $ 2,352 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property and Equipment, net | |
Schedule of property and equipment | Property and equipment consisted of the following (in thousands): Estimated Useful December 31, Life in Years 2022 2021 Computers and software 3 - 5 $ 408 $ 476 Office equipment and furniture 5 721 721 Manufacturing equipment 5 10 10 Leasehold improvements 10 3,082 3,082 Leased assets 5 29 45 Total property and equipment 4,250 4,334 Less accumulated depreciation and amortization (2,762) (2,493) Property and equipment, net $ 1,488 $ 1,841 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2022 2021 Compensation and benefits $ 1,965 $ 2,132 Commercial expenses 93 107 Legal expenses 381 124 Clinical trial expenses 1,421 550 Pharmaceutical development expenses 201 161 Credit balances due to customers 67 87 Accrued purchases — 271 Accrued interest 522 — Other accrued expenses and other current liabilities 811 415 Total accrued expenses and other current liabilities $ 5,461 $ 3,847 |
Loan Payable (Tables)
Loan Payable (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Loan Payable. | |
Schedule of impact of the Loan Agreement on the Company's consolidated balance sheet | December 31, 2022 Principal $ 15,000 Unamortized debt discount (1,570) Loans payable, net 13,430 Current portion of loans payable, net — Carrying Value $ 13,430 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity | |
Summary of net proceeds from the Preferred Stock Transaction | Common Stock Warrant liability $ 1,519 Series A and Series B Preferred Stock 481 Gross Proceeds $ 2,000 |
Schedule of rollforward of warrants | Classification Outstanding, December 31, 2021 Granted Cancelled/Expired Outstanding, December 31, 2022 Exercise Price Per Share Expiration Date July 2022 Offering Liability — 320,000 — 320,000 $6.58 12/28/2027 November 2022 Offering Liability — 1,849,380 — 1,849,380 0.001 Until exercised November 2022 Offering Liability — 2,614,380 — 2,614,380 2.95 11/18/2027 R-Bridge warrants Equity — 200,000 — 200,000 20.50 4/14/2025 Other warrants Equity 11,014 — — 11,014 31.25 - 265.48 1/29/24 - 3/31/27 11,014 4,983,760 — 4,994,774 |
Schedule of share-based compensation expense recognized | The estimated grant-date fair value of the Company’s stock-based awards is amortized on a straight-line basis over the awards’ service periods. Stock-based compensation expense recognized was as follows (in thousands): Year Ended December 31, 2022 2021 Research and development $ 806 $ 1,066 Selling, general and administrative 2,871 3,303 Cost of goods sold (1) 38 Total stock-based compensation $ 3,676 $ 4,407 |
Summary of stock option activity | Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, January 1, 2021 382,561 $ 76.85 7.17 Granted 149,905 39.91 Exercised (5,861) 32.10 Forfeited/Cancelled (28,628) 70.20 Balance, December 31, 2021 497,977 $ 66.64 7.11 Granted 39,998 11.47 Exercised — — Forfeited/Cancelled (186,266) 87.83 Balance, December 31, 2022 351,709 $ 49.15 6.94 Vested or expected to vest at December 31, 2022 351,709 $ 49.15 6.94 Exercisable at December 31, 2022 228,409 $ 56.82 6.15 |
Schedule of weighted-average assumptions: | December 31, 2022 2021 Expected term of options (in years) 5.7 6.2 Risk-free interest rate 2.7 % 1.0 % Expected volatility 98.0 % 98.0 % Dividend yield — % — % |
Schedule of changes in the status of non-vested RSU | Weighted Average Number of Grant Date Awards Fair Value Non-vested at January 1, 2021 150,849 41.59 Granted 174,332 17.50 Vested (62,460) 30.05 Forfeited/Cancelled (25,984) 40.96 Non-vested at December 31, 2021 236,737 26.97 Granted 233,987 1.83 Vested (55,800) 27.19 Forfeited (48,147) 30.55 Non-vested at December 31, 2022 366,777 $ 10.43 |
Schedule of shares available to be granted under equity incentive plans | At December 31, 2022, the Company has the following shares available to be granted: Inducement 2013 Plan Plan Available at December 31, 2021 167,246 10,100 Authorized 264,832 — Granted (273,985) — Shares withheld for taxes not issued 14,201 — Forfeited/Cancelled 232,513 1,900 Available at December 31, 2022 404,807 12,000 |
Schedule of shares of common stock reserved/available | At December 31, 2022, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 343,709 Restricted stock units outstanding under 2013 Plan 366,777 Stock options outstanding under Inducement Plan 8,000 Shares reserved for future issuance under Inducement Plan 12,000 Shares reserved for future issuance under 2013 Employee Stock Purchase Plan 9,032 Warrants outstanding 4,994,774 Total shares of common stock reserved for future issuance 5,734,292 |
Registered direct offering | |
Stockholders' Equity | |
Schedule of assumptions used to estimate fair value of common stock warrant liability using Level 3 inputs | July 29, December 31, 2022 2022 Expected term of warrants (in years) 5.0 4.6 Risk-free interest rate 2.7 % 4.0 % Expected volatility 104.3 % 108.9 % Dividend yield — % — % |
Schedule of rollforward of the Common Stock Warrant liability | Date of issuance, July 29, 2022 $ 1,519 Change in fair value (1,260) Balance, December 31, 2022 $ 259 |
November 2022 Equity Offering | |
Stockholders' Equity | |
Schedule of assumptions used to estimate fair value of common stock warrant liability using Level 3 inputs | November 18, 2022 December 31, 2022 Expected term of warrants (in years) 5.0 4.9 Risk-free interest rate 4.0 % 4.0 % Expected volatility 104.5 % 106.1 % Dividend yield — % — % |
Schedule of rollforward of the Common Stock Warrant liability | Warrant Liability Date of Issuance, November 18 $ 15,144 Change in fair value (9,920) Balance, December 31, 2021 $ 5,224 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies. | |
Schedule of balance sheet information related to leases | Supplemental balance sheet information related to leases was as follows (in thousands): December 31, 2022 December 31, 2021 Operating leases: Operating lease right-of-use assets $ 4,224 $ 4,706 Other current lease liabilities 890 788 Operating lease liabilities 5,419 6,309 Total operating lease liabilities $ 6,309 $ 7,097 Finance leases: Property and equipment, at cost $ 29 $ 45 Accumulated depreciation (4) (41) Property and equipment, net 25 4 Other current lease liabilities 9 4 Other long-term liabilities 17 — Total finance lease liabilities $ 26 $ 4 |
Schedule of components of lease expense | The components of lease expense were as follows (in thousands): Year Ended December 31, 2022 2021 Operating lease costs: Operating lease rental expense $ 1,308 $ 1,228 Other income (1,330) (1,186) Total operating lease costs $ (22) $ 42 Finance lease costs: Amortization of right-of-use assets 7 7 Interest on lease liabilities 1 1 Total finance lease costs $ 8 $ 8 |
Schedule of supplemental cash flow information | Supplemental cash flow information related to leases was as follows (in thousands): Year Ended December 31, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (295) $ (265) Financing cash flows from finance leases (8) (8) |
Schedule of maturities of operating lease liabilities | Our lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2023 1,425 11 2024 1,450 11 2025 1,474 7 2026 1,499 — 2027 and beyond 2,163 — Total minimum lease payments $ 8,011 $ 29 Interest Expense (1,702) (3) Lease liability $ 6,309 $ 26 |
Schedule of maturities of financing lease liabilities | Our lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2023 1,425 11 2024 1,450 11 2025 1,474 7 2026 1,499 — 2027 and beyond 2,163 — Total minimum lease payments $ 8,011 $ 29 Interest Expense (1,702) (3) Lease liability $ 6,309 $ 26 |
Schedule of expected sublease inflows | Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2023 1,139 2024 995 2025 — 2026 — 2027 and beyond — Total minimum lease payments $ 2,134 |
Schedule of weighted average lease term and discount rates | Year Ended December 31, 2022 2021 Weighted average remaining lease term (years) Operating leases 5 6 Finance leases 3 — Weighted average discount rate Operating leases 9.2% 9.2% Finance leases 6.5% 6.5% |
Product Revenue (Tables)
Product Revenue (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Product Revenue. | |
Schedule of major categories of sales-related deductions included in trade receivable allowances | The following table presents a rollforward of the major categories of sales-related deductions included in trade receivable allowances for the year ended December 31, 2022 (in thousands): Sales Discounts Chargebacks Fee for Service Balance, January 1, 2022 $ 1 $ 41 $ 45 Adjustment related to prior period sales — (11) (9) Balance, December 31, 2022 $ 1 $ 30 $ 36 |
License Revenue (Tables)
License Revenue (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Product Revenue. | |
Schedule of license revenue | Year Ended December 31, 2022 2021 Pharmbio Korea Inc. $ 20 $ — Jiangsu Nhwa Pharmaceutical Co. Ltd. — 69 Total license revenues $ 20 $ 69 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Net Loss Per Common Share | |
Schedule of computation of basic and diluted net loss per share | The following table sets forth the computation of basic and diluted net loss per share for the periods indicated (in thousands, except share and per share data): Year Ended December 31, 2022 2021 Basic and diluted net loss per common share calculation: Net loss $ (53,670) $ (51,588) Weighted average common shares outstanding 7,072,362 6,529,074 Net loss per share of common stock - basic and diluted $ (7.59) $ (7.90) |
Schedule of outstanding securities excluded from the computation of diluted weighted shares outstanding as they would have been anti-dilutive | December 31, 2022 2021 Options outstanding 346,367 481,620 RSUs outstanding 366,777 236,737 Warrants outstanding 3,145,394 11,014 Total 3,858,538 729,371 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Schedule of income tax provision | The income tax provision for the years ended December 31, 2022 and 2021 are as follows (in thousands): December 31, 2022 2021 Current: State $ — $ — Federal — — Foreign — — Total — — Deferred State — — Federal — — Foreign — — Total — — Total income tax provision (benefit) $ — $ — |
Schedule of significant components of the Company's deferred tax assets | Significant components of the Company’s net deferred tax assets as of December 31, 2022 and 2021 are as follows (in thousands): December 31, 2022 2021 Deferred tax assets: NOLs $ 46,490 $ 40,810 Research and development credits 16,309 15,575 Research and development expenses capitalized for tax purposes 80,648 93,254 Equity-based compensation 2,257 3,960 Deferred rent 520 691 Depreciation 365 312 Other temporary differences 1,192 657 Total deferred tax assets 147,781 155,259 Deferred tax liabilities: Prepaid expenses (436) (381) Total deferred tax liabilities (436) (381) Net deferred tax assets 147,345 154,878 Less valuation allowance (147,345) (154,878) Net deferred tax asset $ — $ — |
Schedule of reconciliation of income tax expense computed at the statutory federal income tax rate to income taxes as reflected in the financial statements | December 31, 2022 2021 Percent of pre-tax income: U.S. federal statutory income tax rate 21.0 % 21.0 % Permanent Differences 1.3 % (0.2) % State taxes, net of federal benefit 4.8 % 7.2 % Research and development credit 1.5 % 1.3 % Reduction of state tax rate (37.7) % — % Stock compensation (3.2) % (1.4) % Other (1.7) % 0.1 % Change in valuation allowance 14.0 % (28.0) % Effective income tax rate — % — % |
Organization and Description _2
Organization and Description of the Business (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | |
Organization and Description of the Business | ||
Number of operating segments | segment | 1 | |
Accumulated deficit | $ 547,772 | $ 494,102 |
Net loss | $ 53,670 | $ 51,588 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||
Nov. 09, 2022 $ / shares | Apr. 30, 2022 USD ($) subsidiary | Dec. 31, 2022 USD ($) segment item | Dec. 31, 2021 USD ($) | |
Reverse Stock Split | ||||
Reverse stock split ratio | 0.04 | |||
Share price used to pay out fractional shares (in dollars per share) | $ / shares | $ 3.05 | |||
Principles of Consolidation | ||||
Number of wholly owned subsidiaries | subsidiary | 3 | |||
Property and Equipment | ||||
Impairment of property and equipment | $ 0 | $ 0 | ||
Segment Information | ||||
Number of operating segments | segment | 1 | |||
Stock-Based Compensation | ||||
Number of stock-based compensation plans | item | 2 | |||
Dividend yield | 0% | |||
Chesterbrook, Pennsylvania | ||||
Restricted Cash | ||||
Letter of credit collateral | $ 0.6 | |||
Royalty Based Loan Agreement | R-Bridge Financing | ||||
Restricted Cash | ||||
Interest reserve account | $ 2 | $ 1.4 | ||
Computer equipment | ||||
Property and Equipment | ||||
Estimated useful life | P3Y | |||
Laboratory equipment, office equipment, furniture and software | ||||
Property and Equipment | ||||
Estimated useful life | P5Y |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Assets | ||
Cash | $ 9,651 | $ 8,148 |
Total | 40,280 | 68,234 |
Money market mutual funds | ||
Assets | ||
Investments | 28,669 | 58,775 |
Restricted Cash | ||
Assets | ||
Investments | 1,960 | $ 1,311 |
Level 1 | ||
Assets | ||
Cash | 9,651 | |
Total | 40,280 | |
Level 1 | Money market mutual funds | ||
Assets | ||
Investments | 28,669 | |
Level 1 | Restricted Cash | ||
Assets | ||
Investments | 1,960 | |
Level 3 | ||
Liabilities | ||
Liabilities | 5,483 | |
Level 3 | Warrants | ||
Liabilities | ||
Liabilities | $ 5,483 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Additional Information (Details) - July 2022 And November 2022 Equity Offerings | Nov. 30, 2022 |
Volatility | |
Warrants | |
Warrant liability measurement input | 106.4 |
Risk-free interest rate | |
Warrants | |
Warrant liability measurement input | 4 |
Strike price | Minimum | |
Warrants | |
Warrant liability measurement input | 0.263 |
Strike price | Maximum | |
Warrants | |
Warrant liability measurement input | 2.95 |
Estimated remaining term | |
Warrants | |
Warrant liability measurement input | 4.9 |
Inventories - Schedule Of Inven
Inventories - Schedule Of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventories | ||
Finished goods | $ 3,111 | $ 2,488 |
Inventory Valuation Adjustment | (2,205) | (136) |
Total Inventories | $ 906 | $ 2,352 |
Inventories - narrative (Detail
Inventories - narrative (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Inventories | ||
Inventory valuation adjustment | $ 2.1 | $ 0.1 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property and Equipment | ||
Total property and equipment | $ 4,250 | $ 4,334 |
Accumulated depreciation | (2,762) | (2,493) |
Property and equipment, net | 1,488 | 1,841 |
Depreciation and amortization expense | 382 | 428 |
Computers and software | ||
Property and Equipment | ||
Property and equipment, gross | $ 408 | $ 476 |
Computers and software | Minimum | ||
Property and Equipment | ||
Estimated useful life | P3Y | P3Y |
Computers and software | Maximum | ||
Property and Equipment | ||
Estimated useful life | P5Y | P5Y |
Office equipment and furniture | ||
Property and Equipment | ||
Estimated useful life | P5Y | P5Y |
Property and equipment, gross | $ 721 | $ 721 |
Manufacturing equipment | ||
Property and Equipment | ||
Estimated useful life | P5Y | P5Y |
Property and equipment, gross | $ 10 | $ 10 |
Leasehold improvements | ||
Property and Equipment | ||
Estimated useful life | P10Y | P10Y |
Property and equipment, gross | $ 3,082 | $ 3,082 |
Leased assets | ||
Property and Equipment | ||
Estimated useful life | P5Y | P5Y |
Leased assets | $ 29 | $ 45 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses and Other Current Liabilities | ||
Compensation and benefits | $ 1,965 | $ 2,132 |
Commercial expenses | 93 | 107 |
Legal expenses | 381 | 124 |
Clinical trial expenses | 1,421 | 550 |
Pharmaceutical development expenses | 201 | 161 |
Credit balances to customers | 67 | 87 |
Accrued purchases | 271 | |
Accrued interest | 522 | |
Other accrued expenses and other current liabilities | 811 | 415 |
Total accrued expenses and other current liabilities | $ 5,461 | $ 3,847 |
Loan Payable (Details)
Loan Payable (Details) | 1 Months Ended | 12 Months Ended | |
Apr. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) shares | |
Long Term Debt | |||
Warrants to purchase shares of common stock | shares | 4,994,774 | 11,014 | |
Interest expense | $ 1,256,000 | $ 1,000 | |
R-Bridge Financing | Royalty Based Loan Agreement | |||
Long Term Debt | |||
Face amount | $ 40,000,000 | ||
Debt number of tranches | 3 | ||
Interest rate (as a percent) | 7% | ||
Term of loan | 15 years | ||
Net revenue interest in U.S. net sales (as a percent) | 4% | ||
Cap of U.S. revenue interest if Chinese approval occurs by year-end 2023 | $ 10,000,000 | ||
Net revenue interest in U.S. net sales if approval target is not reached (as a percent) | 7% | ||
Amount placed in interest reserve account | $ 2,000,000 | $ 1,400,000 | |
Effective interest rate (as a percent) | 9% | ||
Warrants to purchase shares of common stock | shares | 200,000 | ||
Exercise price (in dollars per share) | $ / shares | $ 20.50 | ||
Warrants term | 3 years | ||
Lender fees and third-party costs | $ 500,000 | ||
Interest expense | $ 1,300,000 | ||
Amortization of debt discount | $ 100,000 | ||
Exercise price | $ / shares | $ 20.50 | ||
R-Bridge Financing | Royalty Based Loan Agreement | Minimum | |||
Long Term Debt | |||
Control premium as a percentage of outstanding principal and interest | 125% | ||
Control premium, amount if triggered | $ 10,000,000 | ||
R-Bridge Financing | Royalty Based Loan Agreement | Maximum | |||
Long Term Debt | |||
Control premium as a percentage of outstanding principal and interest | 150% | ||
Control premium, amount if triggered | $ 20,000,000 | ||
R-Bridge Financing | Royalty Based Loan Agreement - First Tranche | |||
Long Term Debt | |||
Proceeds from royalty-based loan agreement | 15,000,000 | ||
R-Bridge Financing | Royalty Based Loan Agreement - Second Tranche | |||
Long Term Debt | |||
Commercialization milestone payments | 10,000,000 | ||
R-Bridge Financing | Royalty Based Loan Agreement - Third Tranche | |||
Long Term Debt | |||
Milestone payment upon first commercial sale in China | $ 15,000,000 |
Loans Payable Schedule of Debt
Loans Payable Schedule of Debt (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Loan Payable. | |
Principal | $ 15,000 |
Unamortized debt discount | (1,570) |
Loans payable, net | 13,430 |
Carrying Value | $ 13,430 |
Stockholders' Equity - Equity O
Stockholders' Equity - Equity Offerings (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Apr. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Apr. 17, 2019 | |
Stockholders' Equity | |||||
Common stock authorized (in shares) | 200,000,000 | 200,000,000 | |||
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 | |||
Warrants to purchase shares of common stock | 4,994,774 | 11,014 | |||
Net proceeds from the offering | $ 7,948 | ||||
R-Bridge Financing | Royalty Based Loan Agreement | |||||
Stockholders' Equity | |||||
Warrants to purchase shares of common stock | 200,000 | ||||
Warrants term | 3 years | ||||
Exercise price (in dollars per share) | $ 20.50 | ||||
R-Bridge Financing | Royalty Based Loan Agreement - First Tranche | |||||
Stockholders' Equity | |||||
Proceeds from royalty-based loan agreement | $ 15,000 | ||||
HCW ATM Program | |||||
Stockholders' Equity | |||||
Issuance of stock (in shares) | 0 | ||||
Stock available for further issuance | $ 41,900 | ||||
HCW ATM Program | Maximum | |||||
Stockholders' Equity | |||||
Offering amount | $ 50,000 | $ 50,000 |
Stockholders' Equity - Register
Stockholders' Equity - Registered Direct Stock Offering and Concurrent Warrant Issuance (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 5 Months Ended | 12 Months Ended | |||||
Dec. 31, 2022 USD ($) $ / shares shares | Nov. 30, 2022 USD ($) $ / shares shares | Jul. 31, 2022 USD ($) Vote $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) shares | Nov. 18, 2022 | Jul. 19, 2022 | |
Stockholders' Equity | ||||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 4,994,774 | 4,994,774 | 4,994,774 | 11,014 | ||||
Net proceeds from the offering | $ | $ 7,948 | |||||||
Gross Proceeds | $ | $ 2,000 | |||||||
Common stock warrants | ||||||||
Outstanding, beginning balance | 11,014 | |||||||
Granted | 4,983,760 | |||||||
Outstanding, ending balance | 4,994,774 | 4,994,774 | 4,994,774 | 11,014 | ||||
Registered direct offering | ||||||||
Stockholders' Equity | ||||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 320,000 | 320,000 | 320,000 | 320,000 | 0 | |||
Net Proceeds | $ | $ 1,600 | |||||||
Issuance costs | $ | $ 400 | |||||||
Common stock warrants | ||||||||
Outstanding, beginning balance | 0 | |||||||
Granted | 320,000 | |||||||
Outstanding, ending balance | 320,000 | 320,000 | 320,000 | 320,000 | 0 | |||
Exercise price (in dollars per share) | $ / shares | $ 6.58 | $ 6.575 | $ 6.58 | $ 6.58 | ||||
Registered direct offering | Series A convertible preferred stock | ||||||||
Stockholders' Equity | ||||||||
Issuance of stock (in shares) | 72 | |||||||
Registered direct offering | Series B convertible preferred stock | ||||||||
Stockholders' Equity | ||||||||
Issuance of stock (in shares) | 8 | |||||||
Number of votes per share | Vote | 1,000,000 | |||||||
Registered direct offering | Common Stock Warrants | ||||||||
Stockholders' Equity | ||||||||
Gross Proceeds | $ | $ 1,519 | |||||||
Beginning balance | $ | $ 1,519 | |||||||
Change in fair value | $ | (1,260) | |||||||
Ending balance | $ | $ 259 | $ 259 | $ 259 | |||||
Registered direct offering | Common Stock Warrants | Minimum | ||||||||
Stockholders' Equity | ||||||||
Warrants term | 6 months | |||||||
Registered direct offering | Common Stock Warrants | Maximum | ||||||||
Stockholders' Equity | ||||||||
Warrants term | 5 years 6 months | |||||||
Registered direct offering | Common Stock Warrants | Level 3 | Estimated remaining term | ||||||||
Stockholders' Equity | ||||||||
Warrant liability measurement input | 4.6 | 4.6 | 4.6 | 5 | ||||
Registered direct offering | Common Stock Warrants | Level 3 | Risk-free interest rate | ||||||||
Stockholders' Equity | ||||||||
Warrant liability measurement input | 4 | 4 | 4 | 2.7 | ||||
Registered direct offering | Common Stock Warrants | Level 3 | Volatility | ||||||||
Stockholders' Equity | ||||||||
Warrant liability measurement input | 108.9 | 108.9 | 108.9 | 104.3 | ||||
Registered direct offering | Common Stock Warrants | Selling, general and administrative expenses | ||||||||
Stockholders' Equity | ||||||||
Issuance costs | $ | $ 300 | |||||||
Registered direct offering | Series A and Series B Preferred Stock | ||||||||
Stockholders' Equity | ||||||||
Shares issuable upon conversion of convertible preferred stock | 320,000 | |||||||
Gross Proceeds | $ | $ 481 | |||||||
Issuance costs | $ | $ 100 | |||||||
November 2022 Equity Offering | ||||||||
Stockholders' Equity | ||||||||
Issuance of stock (in shares) | 765,000 | |||||||
Net proceeds from the offering | $ | $ 7,600 | |||||||
November 2022 Equity Offering | Common Stock Warrants | ||||||||
Stockholders' Equity | ||||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 2,614,380 | |||||||
Beginning balance | $ | $ 15,144 | |||||||
Change in fair value | $ | (9,920) | |||||||
Ending balance | $ | $ 5,224 | $ 5,224 | $ 5,224 | |||||
Common stock warrants | ||||||||
Outstanding, ending balance | 2,614,380 | |||||||
Exercise price (in dollars per share) | $ / shares | $ 2.95 | |||||||
November 2022 Equity Offering | Common Stock Warrants | Level 3 | Estimated remaining term | ||||||||
Stockholders' Equity | ||||||||
Warrant liability measurement input | 4.9 | 4.9 | 4.9 | 5 | ||||
November 2022 Equity Offering | Common Stock Warrants | Level 3 | Risk-free interest rate | ||||||||
Stockholders' Equity | ||||||||
Warrant liability measurement input | 4 | 4 | 4 | 4 | ||||
November 2022 Equity Offering | Common Stock Warrants | Level 3 | Volatility | ||||||||
Stockholders' Equity | ||||||||
Warrant liability measurement input | 106.1 | 106.1 | 106.1 | 104.5 | ||||
November 2022 Equity Offering | Pre-funded Common Stock Warrants | ||||||||
Stockholders' Equity | ||||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 1,849,380 | |||||||
Common stock warrants | ||||||||
Outstanding, ending balance | 1,849,380 | |||||||
Exercise price (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||
November 2022 Equity Offering Expiring 2032 | ||||||||
Stockholders' Equity | ||||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 1,849,380 | 1,849,380 | 1,849,380 | 0 | ||||
Common stock warrants | ||||||||
Outstanding, beginning balance | 0 | |||||||
Granted | 1,849,380 | |||||||
Outstanding, ending balance | 1,849,380 | 1,849,380 | 1,849,380 | 0 | ||||
Exercise price (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||
November 2022 Equity Offering Expiring 2027 | ||||||||
Stockholders' Equity | ||||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 2,614,380 | 2,614,380 | 2,614,380 | 0 | ||||
Common stock warrants | ||||||||
Outstanding, beginning balance | 0 | |||||||
Granted | 2,614,380 | |||||||
Outstanding, ending balance | 2,614,380 | 2,614,380 | 2,614,380 | 0 | ||||
Exercise price (in dollars per share) | $ / shares | $ 2.95 | $ 2.95 | $ 2.95 | |||||
R-Bridge Financing | ||||||||
Stockholders' Equity | ||||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 200,000 | 200,000 | 200,000 | 0 | ||||
Common stock warrants | ||||||||
Outstanding, beginning balance | 0 | |||||||
Granted | 200,000 | |||||||
Outstanding, ending balance | 200,000 | 200,000 | 200,000 | 0 | ||||
Exercise price (in dollars per share) | $ / shares | $ 20.50 | $ 20.50 | $ 20.50 | |||||
Other Warrants | ||||||||
Stockholders' Equity | ||||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 11,014 | 11,014 | 11,014 | 11,014 | ||||
Common stock warrants | ||||||||
Outstanding, beginning balance | 11,014 | |||||||
Outstanding, ending balance | 11,014 | 11,014 | 11,014 | 11,014 | ||||
Other Warrants | Minimum | ||||||||
Common stock warrants | ||||||||
Exercise price (in dollars per share) | $ / shares | $ 31.25 | $ 31.25 | $ 31.25 | |||||
Other Warrants | Maximum | ||||||||
Common stock warrants | ||||||||
Exercise price (in dollars per share) | $ / shares | $ 265.48 | $ 265.48 | $ 265.48 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Incentive Plans (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 15, 2016 | Dec. 31, 2022 | Dec. 31, 2021 | |
Equity Incentive Plans | |||
Stock-based compensation | $ 3,676 | $ 4,407 | |
Research and Development Expense | |||
Equity Incentive Plans | |||
Stock-based compensation | 806 | 1,066 | |
General and Administrative Expense | |||
Equity Incentive Plans | |||
Stock-based compensation | 2,871 | 3,303 | |
Cost of goods sold | |||
Equity Incentive Plans | |||
Stock-based compensation | $ (1) | $ 38 | |
Maximum | |||
Equity Incentive Plans | |||
Term of award | 10 years | ||
Vesting period | 4 years | ||
Inducement Plan | |||
Equity Incentive Plans | |||
Authorized (in shares) | 20,000 |
Stockholders' Equity - Options
Stockholders' Equity - Options Outstanding (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Nov. 09, 2022 | |
Weighted Average Remaining Contractual Term | ||||
Closing price of Company's stock (in dollars per share) | $ 3.05 | |||
Employee Stock Option | ||||
Number of Shares | ||||
Balance at the beginning of the period (in shares) | 497,977 | 382,561 | ||
Granted (in shares) | 39,998 | 149,905 | ||
Exercised (in shares) | (5,861) | |||
Forfeited/Cancelled (in shares) | (186,266) | (28,628) | ||
Balance at the end of the period (in shares) | 351,709 | 497,977 | 382,561 | |
Vested or expected to vest at the end of the period (in shares) | 351,709 | |||
Exercisable at the end of the period (in shares) | 228,409 | |||
Weighted-Average Exercise Price | ||||
Balance at the beginning of the period (in dollars per share) | $ 66.64 | $ 76.85 | ||
Granted (in dollars per share) | 11.47 | 39.91 | ||
Exercised (in dollars per share) | 32.10 | |||
Forfeited/Cancelled (in dollars per share) | 87.83 | 70.20 | ||
Balance at the end of the period (in dollars per share) | 49.15 | $ 66.64 | $ 76.85 | |
Vested or expected to vest at the end of the period (in dollars per share) | 49.15 | |||
Exercisable at the end of the period (in dollars per share) | $ 56.82 | |||
Intrinsic value of options exercisable | $ 0 | |||
Weighted Average Remaining Contractual Term | ||||
Options Outstanding at the end of the period | 6 years 11 months 8 days | 7 years 1 month 9 days | 7 years 2 months 1 day | |
Vested or expected to vest at the end of the period | 6 years 11 months 8 days | |||
Exercisable at the end of the period | 6 years 1 month 24 days | |||
Closing price of Company's stock (in dollars per share) | $ 1.43 |
Stockholders' Equity - Assumpti
Stockholders' Equity - Assumptions Used (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stockholders' Equity | ||
Dividend yield | 0% | |
Employee Stock Option | ||
Stockholders' Equity | ||
Weighted average grant date fair value (in dollars per share) | $ 8.88 | $ 31.19 |
Expected term of options (in years) | 5 years 8 months 12 days | 6 years 2 months 12 days |
Risk-free interest rate (as a percent) | 2.70% | 1% |
Expected volatility (as a percent) | 98% | 98% |
Unrecognized compensation expense | $ 2.9 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 2 years 21 days |
Stockholders' Equity - Non-vest
Stockholders' Equity - Non-vested RSUs (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Weighted Average Grant Date Fair Value | ||
Stock-based compensation | $ 3,676 | $ 4,407 |
Restricted Stock Units | ||
Number of Shares | ||
Non-vested at beginning of period (in shares) | 236,737 | 150,849 |
Granted (in shares) | 233,987 | 174,332 |
Vested (in shares) | (55,800) | (62,460) |
Forfeited/Cancelled (in shares) | (48,147) | (25,984) |
Non-vested at end of period (in shares) | 366,777 | 236,737 |
Weighted Average Grant Date Fair Value | ||
Non-vested at beginning of period (in dollars per share) | $ 26.97 | $ 41.59 |
Granted (in dollars per share) | 1.83 | 17.50 |
Vested (in dollars per share) | 27.19 | 30.05 |
Forfeited (in dollars per share) | 30.55 | 40.96 |
Non-vested at end of period (in dollars per share) | $ 10.43 | $ 26.97 |
Stock-based compensation | $ 1,500 | $ 1,800 |
Unrecognized compensation expense | $ 3,700 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 2 years 7 months 13 days | |
Shares of common stock underlying vested RSUs withheld | 14,201 |
Stockholders' Equity - Availabl
Stockholders' Equity - Available for Grant (Details) - shares | 12 Months Ended | |
Dec. 15, 2016 | Dec. 31, 2022 | |
2013 plan | ||
Stockholders' Equity | ||
Balance at the beginning of the period (in shares) | 167,246 | |
Authorized (in shares) | 264,832 | |
Granted (in shares) | (273,985) | |
Shares withheld for taxes not issued (in shares) | 14,201 | |
Forfeited/Cancelled (in shares) | 232,513 | |
Balance at the end of the period (in shares) | 404,807 | |
Inducement Plan | ||
Stockholders' Equity | ||
Balance at the beginning of the period (in shares) | 10,100 | |
Authorized (in shares) | 20,000 | |
Forfeited/Cancelled (in shares) | 1,900 | |
Balance at the end of the period (in shares) | 12,000 |
Stockholders' Equity - Shares A
Stockholders' Equity - Shares Available for Future Issuance (Details) | Dec. 31, 2022 shares |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 5,734,292 |
Warrants | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 4,994,774 |
2013 plan | Employee Stock Option | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 343,709 |
2013 plan | Restricted Stock Units | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 366,777 |
2013 plan | Employee Stock Purchase Plan | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 9,032 |
Inducement Plan | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 12,000 |
Inducement Plan | Employee Stock Option | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 8,000 |
Commitments and Contingencies -
Commitments and Contingencies - Leases (Details) - Chesterbrook, Pennsylvania | Oct. 02, 2020 | Oct. 11, 2018 ft² $ / ft² | Dec. 31, 2022 ft² |
Leases | |||
Number of square feet of space leased on the first floor | 8,231 | ||
Number of square feet of space leased on the second floor | 40,565 | ||
Sublease Agreements | Vanguard Group, Inc | |||
Leases | |||
Number of square feet of space being subleased on second floor | 40,565 | ||
Initial term of sublease | 37 months | ||
Term of optional sublease extension | 3 years | ||
Term of second optional sublease extension | 3 years | ||
Amount per square foot less for rent during months 2 to 13 | $ / ft² | 0.50 | ||
Amount per square foot for rent after month 14 | $ / ft² | 1 |
Commitments and Contingencies_2
Commitments and Contingencies - Balance sheet information related to leases (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Leases | ||
Operating lease right-of-use assets | $ 4,224 | $ 4,706 |
Operating lease liabilities - Current | $ 890 | $ 788 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Lease Liability Current | Lease Liability Current |
Operating lease liabilities - Noncurrent | $ 5,419 | $ 6,309 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease Liability Noncurrent | Lease Liability Noncurrent |
Lease Liability | $ 6,309 | $ 7,097 |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | Lease Liability Current, Lease Liability Noncurrent | Lease Liability Current, Lease Liability Noncurrent |
Property and equipment, at cost | $ 4,250 | $ 4,334 |
Accumulated depreciation | (2,762) | (2,493) |
Property and equipment, net | 1,488 | 1,841 |
Finance lease liabilities - Current | $ 9 | $ 4 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Lease Liability Current | Lease Liability Current |
Finance lease liabilities - Noncurrent | $ 17 | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease Liability Noncurrent | Lease Liability Noncurrent |
Lease Liability | $ 26 | $ 4 |
Finance Lease, Liability, Statement of Financial Position [Extensible List] | Lease Liability Current, Lease Liability Noncurrent | Lease Liability Current, Lease Liability Noncurrent |
Finance leased assets | ||
Leases | ||
Property and equipment, at cost | $ 29 | $ 45 |
Accumulated depreciation | (4) | (41) |
Property and equipment, net | $ 25 | $ 4 |
Commitments and Contingencies_3
Commitments and Contingencies - Components of lease expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating lease costs: | ||
Operating lease rental expense | $ 1,308 | $ 1,228 |
Other income | (1,330) | (1,186) |
Total operating lease costs | (22) | 42 |
Finance lease costs: | ||
Amortization of right-of-use assets | 7 | 7 |
Interest on lease liabilities | 1 | 1 |
Total finance lease costs | $ 8 | $ 8 |
Commitments and Contingencies_4
Commitments and Contingencies - Cash flow information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies. | ||
Operating cash flows from operating leases | $ (295) | $ (265) |
Financing cash flows from finance leases | $ (8) | $ (8) |
Commitments and Contingencies_5
Commitments and Contingencies - Lease liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Operating Leases | ||
2023 | $ 1,425 | |
2024 | 1,450 | |
2025 | 1,474 | |
2026 | 1,499 | |
2027 and beyond | 2,163 | |
Total minimum lease payments | 8,011 | |
Interest Expense | (1,702) | |
Lease Liability | 6,309 | $ 7,097 |
Financing Leases | ||
2023 | 11 | |
2024 | 11 | |
2025 | 7 | |
Total minimum lease payments | 29 | |
Interest Expense | (3) | |
Lease Liability | 26 | $ 4 |
Sublease | ||
2023 | 1,139 | |
2024 | 995 | |
Total minimum lease payments | $ 2,134 |
Commitments and Contingencies_6
Commitments and Contingencies - Lease term and discount rates (Details) - USD ($) $ in Millions | Dec. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies. | ||
Weighted average remaining lease term - Operating leases | 5 years | 6 years |
Weighted average remaining lease term - Finance leases | 3 years | |
Weighted average discount rate - Operating leases | 9.20% | 9.20% |
Weighted average discount rate - Finance leases | 6.50% | 6.50% |
Deferred rent | $ 0.1 | $ 0 |
Product Revenue (Details)
Product Revenue (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) item | |
Sales Discounts | |
Balance | $ 1,000 |
Balance | 1,000 |
Chargebacks | |
Balance | 41,000 |
Adjustment related to prior period sales | (11,000) |
Balance | 30,000 |
Fee for Service | |
Balance | 45,000 |
Adjustment related to prior period sales | (9,000) |
Balance | 36,000 |
Outstanding accounts receivable | 19,000 |
Returns reserve adjustment | 383,000 |
Sales allowance included with accrued expenses and other current liabilities. | $ 67,000 |
Product revenue | Revenue Benchmark | Customer Concentration Risk | |
Revenue | |
Number of customers | item | 3 |
Concentration risk percentage | 100% |
OLINVYK | |
Product Returns | |
Time period that customers have right to return unopened product | 18 months |
Time period prior to labeled expiration date that customers have right to return unopened product | 6 months |
Time period after labeled expiration date that customers have right to return unopened product | 12 months |
Time period after product launch that customers have right to return product from initial purchase | 6 months |
Product shelf life | 48 months |
OLINVYK | Minimum | |
Product Returns | |
Time period to evaluate historical sales | 2 years |
OLINVYK | Maximum | |
Product Returns | |
Time period to evaluate historical sales | 3 years |
License Revenue (Details)
License Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2020 | Apr. 30, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pharmbio Korea Inc | ||||
Licensing Arrangements | ||||
Upfront payment | $ 3,000 | |||
Withholding taxes | $ 500 | |||
Time period for written notice to terminate license agreement | 180 days | |||
Pharmbio Korea Inc | Minimum | ||||
Licensing Arrangements | ||||
Time period to form a committee prior to the anticipated date of regulatory approval | 6 months | |||
Pharmbio Korea Inc | Maximum | ||||
Licensing Arrangements | ||||
Commercialization milestone payments | $ 500 | |||
Royalties on product sales, percentage | 20% | |||
Jiangsu Nhwa Pharmaceutical Co Ltd | Minimum | ||||
Licensing Arrangements | ||||
Time period to form a committee prior to the anticipated date of regulatory approval | 6 months | |||
Jiangsu Nhwa Pharmaceutical Co Ltd | Licensing agreements for development and commercialization | ||||
Licensing Arrangements | ||||
Upfront payment | $ 3,000 | $ 2,500 | ||
Withholding taxes | $ 300 | $ 300 | ||
Time period for written notice to terminate license agreement | 180 days | |||
Milestone payment upon regulatory approval in China | $ 3,000 | |||
Milestone payment upon sales targets reached in China | $ 6,000 | |||
Royalty percentage on net product sales in China after milestones met | 10% | |||
License revenue | ||||
Licensing Arrangements | ||||
Total revenue | $ 20 | $ 69 | ||
License revenue | Pharmbio Korea Inc | ||||
Licensing Arrangements | ||||
Total revenue | $ 20 | |||
License revenue | Jiangsu Nhwa Pharmaceutical Co Ltd | ||||
Licensing Arrangements | ||||
Total revenue | $ 69 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Nov. 30, 2022 | |
Basic and diluted net loss per common share calculation: | |||
Net loss | $ (53,670) | $ (51,588) | |
Weighted average common shares outstanding, basic (in shares) | 7,072,362 | 6,529,074 | |
Weighted average common shares outstanding, diluted (in shares) | 7,072,362 | 6,529,074 | |
Net loss per share of common stock, basic (in dollars per share) | $ (7.59) | $ (7.90) | |
Net loss per share of common stock, diluted (in dollars per share) | $ (7.59) | $ (7.90) | |
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 3,858,538 | 729,371 | |
November 2022 Equity Offering [Member] | Pre-funded Common Stock Warrants | |||
Basic and diluted net loss per common share calculation: | |||
Exercise price (in dollars per share) | $ 0.001 | $ 0.001 | |
Employee Stock Option | |||
Basic and diluted net loss per common share calculation: | |||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 346,367 | 481,620 | |
Restricted Stock Units | |||
Basic and diluted net loss per common share calculation: | |||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 366,777 | 236,737 | |
Warrants | |||
Basic and diluted net loss per common share calculation: | |||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 3,145,394 | 11,014 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes | ||
(Decrease) increase in valuation allowance | $ (7.5) | $ 14.4 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
NOLs | $ 46,490 | $ 40,810 |
Research and development credits | 16,309 | 15,575 |
Research and development expenses capitalized for tax purposes | 80,648 | 93,254 |
Equity-based compensation | 2,257 | 3,960 |
Deferred rent | 520 | 691 |
Depreciation | 365 | 312 |
Other temporary differences | 1,192 | 657 |
Total deferred tax assets | 147,781 | 155,259 |
Deferred tax liabilities: | ||
Prepaid expenses | (436) | (381) |
Total deferred tax liabilities | (436) | (381) |
Net deferred tax assets | 147,345 | 154,878 |
Less valuation allowance | (147,345) | (154,878) |
Net deferred tax asset | $ 0 | $ 0 |
Income Taxes - Effective Tax Ra
Income Taxes - Effective Tax Rate Reconciliation (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2031 | Dec. 31, 2022 | Dec. 31, 2021 | |
Percent of pre-tax income: | |||
U.S. federal statutory income tax rate | 21% | 21% | |
Permanent Differences | 1.30% | (0.20%) | |
State taxes, net of federal benefit | 4.80% | 7.20% | |
Research and development credit | 1.50% | 1.30% | |
Reduction of state tax rate | (37.70%) | ||
Stock compensation | (3.20%) | (1.40%) | |
Other | (1.70%) | 0.10% | |
Change in valuation allowance | 14% | (28.00%) | |
Effective income tax rate | 0% | 0% | |
Research and development expenses capitalized | $ 18.7 | ||
Uncertain tax positions | $ 0 | ||
State income taxes | |||
State income tax rate | 9.99% | ||
Deferred tax expense due to change in state tax rate | $ 25.7 | ||
Forecast | |||
State income taxes | |||
State income tax rate | 4.99% | ||
U.S. federal | |||
Operating loss carryforwards | |||
Net operating loss carryforwards | 188.7 | ||
State | |||
Operating loss carryforwards | |||
Tax credit carryforwards | 174.3 | ||
Research Tax Credit Carryforward | U.S. federal | |||
Operating loss carryforwards | |||
Tax credit carryforwards | $ 16.3 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Employee Benefit Plan | |
Employer matching contribution for employee's contributions of the first 3% of eligible compensation | 100% |
Percentage of eligible compensation, matched 100% by employer | 3% |
Employer matching contribution for employee's contributions of the next 2% of eligible compensation | 50% |
Percentage of eligible compensation, matched 50% by employer | 2% |
Company's matching contributions to the plan | $ 0.3 |