Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 10, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
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 Boulevard, 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, $0.001 par value | |
Trading Symbol | TRVN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 13,712,139 | |
Entity Central Index Key | 0001429560 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 28,097 | $ 38,320 |
Inventories | 901 | 906 |
Prepaid expenses and other current assets | 3,972 | 1,782 |
Total current assets | 32,970 | 41,008 |
Restricted cash | 540 | 1,960 |
Property and equipment, net | 1,343 | 1,488 |
Right-of-use lease asset | 3,955 | 4,224 |
Other assets | 51 | |
Total assets | 38,859 | 48,680 |
Current liabilities: | ||
Accounts payable, net | 2,527 | 2,372 |
Accrued expenses and other current liabilities | 4,695 | 5,461 |
Lease liability | 954 | 899 |
Total current liabilities | 8,176 | 8,732 |
Loans payable, net | 14,176 | 13,430 |
Leases, net of current portion | 4,946 | 5,436 |
Warrant liability | 1,779 | 5,483 |
Total liabilities | 29,077 | 33,081 |
Stockholders' equity: | ||
Preferred stock-$0.001 par value; 5,000,000 shares authorized, none issued or outstanding at June 30, 2023 and December 31, 2022 | ||
Common stock-$0.001 par value; 200,000,000 shares authorized at June 30, 2023 and December 31, 2022; 13,712,139 and 7,744,692 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 14 | 8 |
Additional paid-in capital | 573,371 | 563,362 |
Accumulated deficit | (563,603) | (547,772) |
Accumulated other comprehensive income | 1 | |
Total stockholders' equity | 9,782 | 15,599 |
Total liabilities and stockholders' equity | $ 38,859 | $ 48,680 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
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) | 13,712,139 | 7,744,692 |
Common stock outstanding (in shares) | 13,712,139 | 7,744,692 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenue: | ||||
Total revenue | $ 3,021 | $ 3,027 | $ 20 | |
Operating expenses: | ||||
Cost of goods sold | 88 | $ 216 | 214 | 423 |
Selling, general and administrative | 5,138 | 10,306 | 11,227 | 21,320 |
Research and development | 3,991 | 4,291 | 7,900 | 9,550 |
Total operating expenses | 9,217 | 14,813 | 19,341 | 31,293 |
Loss from operations | (6,196) | (14,813) | (16,314) | (31,273) |
Other income (expense): | ||||
Change in fair value of warrant liability | (763) | 1,703 | ||
Other income (expense), net | 49 | 64 | 57 | 109 |
Interest income | 323 | 95 | 612 | 119 |
Interest expense | (1,122) | (325) | (1,568) | (325) |
(Loss) gain on foreign currency exchange | (3) | (2) | (21) | |
Foreign income tax expense | (300) | (300) | ||
Total other income (expense), net | (1,816) | (168) | 483 | (97) |
Net Loss | (8,012) | (14,981) | (15,831) | (31,370) |
Other comprehensive loss | ||||
Unrealized gain on marketable securities | (60) | (60) | ||
Comprehensive loss | $ (8,012) | $ (15,041) | $ (15,831) | $ (31,430) |
Per share information: | ||||
Net loss per share of common stock, basic (in dollars per share) | $ (0.69) | $ (2.26) | $ (1.49) | $ (4.74) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.69) | $ (2.26) | $ (1.49) | $ (4.74) |
Weighted average common shares outstanding, basic (in shares) | 11,580,128 | 6,621,083 | 10,592,586 | 6,620,942 |
Weighted average common shares outstanding, diluted (in shares) | 11,580,128 | 6,621,083 | 10,592,586 | 6,620,942 |
Product revenue | ||||
Revenue: | ||||
Total revenue | $ 21 | $ 27 | ||
License revenue | ||||
Revenue: | ||||
Total revenue | $ 3,000 | $ 3,000 | $ 20 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Subscriptions Receivable | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total |
Beginning Balance at Dec. 31, 2021 | $ 7 | $ 558,725 | $ (494,102) | $ 64,630 | ||
Beginning Balance (in shares) at Dec. 31, 2021 | 6,618,096 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 1,155 | 1,155 | ||||
Net loss | (16,389) | (16,389) | ||||
Ending Balance at Mar. 31, 2022 | $ 7 | 559,880 | (510,491) | 49,396 | ||
Ending Balance (in shares) at Mar. 31, 2022 | 6,618,096 | |||||
Beginning Balance at Dec. 31, 2021 | $ 7 | 558,725 | (494,102) | 64,630 | ||
Beginning Balance (in shares) at Dec. 31, 2021 | 6,618,096 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Net loss | (31,370) | |||||
Ending Balance at Jun. 30, 2022 | $ 7 | 561,491 | $ (23) | (525,472) | $ (60) | 35,943 |
Ending Balance (in shares) at Jun. 30, 2022 | 6,624,537 | |||||
Beginning Balance at Mar. 31, 2022 | $ 7 | 559,880 | (510,491) | 49,396 | ||
Beginning Balance (in shares) at Mar. 31, 2022 | 6,618,096 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 1,008 | 1,008 | ||||
Issuance of common stock warrants in connection with loan payable | 603 | 603 | ||||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes | (23) | (23) | ||||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes (in shares) | 6,441 | |||||
Unrealized loss on marketable securities | (60) | (60) | ||||
Net loss | (14,981) | (14,981) | ||||
Ending Balance at Jun. 30, 2022 | $ 7 | 561,491 | $ (23) | (525,472) | (60) | 35,943 |
Ending Balance (in shares) at Jun. 30, 2022 | 6,624,537 | |||||
Beginning Balance at Dec. 31, 2022 | $ 8 | 563,362 | (547,772) | 1 | $ 15,599 | |
Beginning Balance (in shares) at Dec. 31, 2022 | 7,744,692 | 7,744,692 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 806 | $ 806 | ||||
Exercise of pre-funded warrants and related reclassification of warrant liability | $ 1 | 1,568 | 1,569 | |||
Exercise of pre-funded warrants and related reclassification of warrant liability (in shares) | 1,230,380 | |||||
Unrealized loss on marketable securities | (1) | (1) | ||||
Net loss | (7,819) | (7,819) | ||||
Ending Balance at Mar. 31, 2023 | $ 9 | 565,736 | (555,591) | 10,154 | ||
Ending Balance (in shares) at Mar. 31, 2023 | 8,975,072 | |||||
Beginning Balance at Dec. 31, 2022 | $ 8 | 563,362 | (547,772) | $ 1 | $ 15,599 | |
Beginning Balance (in shares) at Dec. 31, 2022 | 7,744,692 | 7,744,692 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Net loss | $ (15,831) | |||||
Ending Balance at Jun. 30, 2023 | $ 14 | 573,371 | (563,603) | $ 9,782 | ||
Ending Balance (in shares) at Jun. 30, 2023 | 13,712,139 | 13,712,139 | ||||
Beginning Balance at Mar. 31, 2023 | $ 9 | 565,736 | (555,591) | $ 10,154 | ||
Beginning Balance (in shares) at Mar. 31, 2023 | 8,975,072 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 702 | 702 | ||||
Exercise of pre-funded warrants and related reclassification of warrant liability | $ 1 | 433 | 434 | |||
Exercise of pre-funded warrants and related reclassification of warrant liability (in shares) | 619,000 | |||||
Issuance of stock | $ 4 | 6,500 | 6,504 | |||
Issuance of stock (in shares) | 4,116,039 | |||||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes (in shares) | 2,028 | |||||
Net loss | (8,012) | (8,012) | ||||
Ending Balance at Jun. 30, 2023 | $ 14 | $ 573,371 | $ (563,603) | $ 9,782 | ||
Ending Balance (in shares) at Jun. 30, 2023 | 13,712,139 | 13,712,139 |
Statements of Stockholders' E_2
Statements of Stockholders' Equity (Parenthetical) - $ / shares | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Mar. 31, 2022 |
Statements of Stockholders' Equity | |||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Operating activities: | ||
Net loss | $ (15,831) | $ (31,370) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 165 | 210 |
Stock-based compensation | 1,508 | 2,163 |
Noncash interest expense | 746 | 101 |
Change in fair value of warrant liability | (1,703) | |
Accretion of bond discount on marketable securities | (18) | |
Change in right-of-use asset | 269 | 232 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (2,241) | (282) |
Inventories | 5 | (638) |
Operating lease liabilities | (429) | (380) |
Accounts payable, accrued expenses and other liabilities | (613) | (225) |
Net cash used in operating activities | (18,124) | (30,207) |
Investing activities: | ||
Purchases of property and equipment | (20) | |
Purchases of marketable securities | (29,976) | |
Net cash provided by (used in) investing activities | (20) | (29,976) |
Financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 6,504 | |
Proceeds from exercise of pre-funded warrants | 2 | |
Finance lease payments | (5) | (3) |
Change in equity receivable | (23) | |
Proceeds from loan payable and issuance of common stock warrants, net of costs | 14,475 | |
Net cash provided by financing activities | 6,501 | 14,449 |
Net decrease in cash, cash equivalents and restricted cash | (11,643) | (45,734) |
Cash, cash equivalents and restricted cash-beginning of period | 40,280 | 68,234 |
Cash, cash equivalents and restricted cash-end of period | 28,637 | $ 22,500 |
Supplemental disclosure of cash flow information: | ||
Reclassification of warrant liability upon exercise of pre-funded warrants | $ 2,001 |
Organization and Description of
Organization and Description of the Business | 6 Months Ended |
Jun. 30, 2023 | |
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 commercializing its lead asset, OLINVYK® (oliceridine) injection, or OLINVYK, and to research and development, including nonclinical studies and clinical trials. The Company has never been profitable. 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 its inception, the Company has incurred losses and negative cash flows from operations. At June 30, 2023, the Company had an accumulated deficit of $563.6 million. The Company’s net loss was $15.8 million and $31.4 million for the six months ended June 30, 2023 and 2022, 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, or ASC 205-40, which requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. The Company expects that its existing balance of cash and cash equivalents as of June 30, 2023 is not sufficient to fund operations for more than one year after the date of this filing and therefore management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern. Management’s plans to mitigate this risk include raising additional capital through equity or debt financings, or through strategic transactions. Management’s plans may also include the deferral of certain operating expenses unless and until additional capital is received. However, there can be no assurance that the Company will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to the Company, or that the Company will be successful in deferring certain operating expenses. If the Company is unable to raise sufficient additional capital or defer sufficient operating expenses, the Company may be compelled to reduce the scope of its operations and planned capital expenditures. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the ASC and Accounting Standards Updates, or ASUs, of the FASB. The Company’s functional currency is the U.S. dollar. The consolidated financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s consolidated balance sheets as of June 30, 2023, its results of operations and its comprehensive loss for the six months ended June 30, 2023 and 2022, its consolidated statements of stockholders’ equity for the period from January 1, 2023 to June 30, 2023 and for the period January 1, 2022 to June 30, 2022, and its consolidated statements of cash flows for the six months ended June 30, 2023 and 2022. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and accompanying notes included in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2022. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. The financial data and other information disclosed in these notes related to the six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. Principles of Consolidation In connection with the royalty-based financing agreement disclosed in Note 5, 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 June 30, 2023. All significant intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of consolidated 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. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. 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, at June 30, 2023, 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. Product Revenue The Company accounts for product revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606). The Company performs the following five steps to recognize revenue under ASC 606: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue when it believes that it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services that will be transferred to the customer. The Company sells OLINVYK to wholesalers in the US (collectively, “customers”). These customers subsequently resell the Company’s products generally to hospitals, ambulatory surgical centers and other purchasers of OLINVYK. The Company recognizes revenue from OLINVYK sales at the point customers obtain control of the product, which generally occurs upon delivery. The transaction price that is recognized as revenue for products includes an estimate of variable consideration which is described below. 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 based on the probability that a significant reversal in the amount of cumulative revenue may occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. Actual amounts of consideration ultimately received may vary from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect product sales and earnings in the period such variances become known. 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. 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. 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. Product Returns Generally, the Company’s customers have the right to return any unopened product during the eighteen (18) month period beginning six (6) months prior to the labeled expiration date and ending twelve (12) months after the labeled expiration date. Since the Company did not have a history of OLINVYK returns when the product was launched, the Company estimated returns based on industry data for comparable products in the market. As the Company sells OLINVYK and establishes historical sales over a longer period of time, the Company places more reliance on historical purchasing, demand, return patterns of its customers and the amount of OLINVYK held by wholesalers, when evaluating reserves for product returns. OLINVYK has a forty-eight (48) month shelf life. 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. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments ASC 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 fair value of the Company’s cash, cash equivalents, restricted cash and warrant liability as of June 30, 2023 and December 31, 2022 (in thousands): June 30, Quoted Prices in Active Markets Significant Other Observable Inputs Unobservable Inputs Description: 2023 (Level 1) (Level 2) (Level 3) Assets: Cash $ 1,490 $ 1,490 $ — $ — Money Market Funds 26,607 26,607 — — Restricted Cash 540 540 — — Total assets measured and recorded at fair value $ 28,637 $ 28,637 $ — $ — Liabilities: Warrant Liability 1,779 — — 1,779 Total liabilities measured and recorded at fair value $ 1,779 $ — $ — $ 1,779 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 — — 5,483 Total liabilities measured and recorded at fair value $ 5,483 $ — $ — $ 5,483 (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no 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 warrant liability was estimated using a Black-Scholes Option Pricing Model. Registered Direct Stock Offering and Concurrent Warrant Issuance The fair value of the July 2022 Offering 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: June 30, December 31, 2023 2022 Expected term of warrants (in years) 4.1 4.6 Risk-free interest rate 4.3 % 4.0 % Expected volatility 123.9 % 108.9 % Dividend yield — % — % The following is a roll forward of the July 2022 Offering common stock warrant liability (in thousands): Balance, December 31, 2022 $ 259 Change in fair value (104) Balance, June 30, 2023 $ 155 November 2022 Equity Offering and Warrant Issuance The fair value of the November 2022 Offering 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: June 30, 2023 December 31, 2022 Expected term of warrants (in years) 4.4 4.9 Risk-free interest rate 4.2 % 4.0 % Expected volatility 126.5 % 106.1 % Dividend yield — % — % The following is a roll forward of the November 2022 Offering common stock warrant liability (in thousands): Warrant Liability Balance, December 31, 2022 $ 5,224 Change in fair value (1,599) Exercise of pre-funded common stock warrants (2,001) Balance, June 30, 2023 $ 1,624 Warrants As of June 30, 2023, the Company had the following common stock warrants outstanding: Classification Warrants Exercise Price Expiration Date July 2022 Offering Liability 320,000 $6.58 12/28/2027 November 2022 Offering Liability 2,614,380 2.95 11/18/2027 R-Bridge warrants Equity 200,000 20.50 4/14/2025 Other warrants Equity 11,014 31.25 – 265.48 1/29/2024 – 3/31/2027 3,145,394 The Company classifies investments available to fund current operations as current assets on its balance sheet. As of June 30, 2023 and 2022, 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. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2023 | |
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. Inventory consists of the following (in thousands): June 30, 2023 December 31, 2022 Finished goods $ 901 $ 3,111 Inventory Valuation Adjustment — (2,205) Total Inventories $ 901 $ 906 |
Loan Payable
Loan Payable | 6 Months Ended |
Jun. 30, 2023 | |
Loan Payable. | |
Loan Payable | 5. Loan Payable In April 2022, the Company, through its wholly owned subsidiary Trevena SPV2 LLC, entered into a royalty-based loan agreement (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 (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): June 30, 2023 Principal and accreted interest $ 15,670 Unamortized debt discount (1,494) Loans payable, net $ 14,176 The term loans bear interest at a rate per annum equal to 7.00% and will mature on the earlier of (i) the fifteen million in accordance with the Loan Agreement. Upon a change in control or in the event the Company elects to repay any outstanding borrowings prior to their contractual maturity, the Company is required to pay a control premium equal to the greater of (i) principal and interest and (ii) $10.0 million or $20.0 million depending on the timing in which the triggering event occurs as further provided in the Loan Agreement. 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. The interest reserve account was classified as restricted cash on the Company’s balance sheet at December 31, 2022. During the second quarter of 2023, the Company agreed to transfer the remaining funds, approximately $1.0 million, to R-Bridge to prepay future interest payments. As a result, the Company has classified the amount as prepaid interest on its consolidated balance sheet at June 30, 2023. Repayments of all borrowings, interest and other related payments, under the Loan Agreement are 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 June 30, 2023, there were no events of default pursuant to the Loan Agreement and the Company was in compliance with all covenants. 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 will be exercisable for a period of 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 six months ended June 30, 2023, the Company recognized interest expense of $1.6 million, 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. |
Stock Compensation
Stock Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Stock Compensation | |
Stock Compensation | 6. Stock Compensation The estimated grant date fair value of the Company’s share-based awards is amortized on a straight-line basis over the awards’ service periods. Share based compensation expense recognized was as follows (in thousands): Six Months Ended June 30, 2023 2022 Research and development $ 295 $ 494 Selling, general and administrative 1,213 1,655 Cost of goods sold — 14 Total stock-based compensation $ 1,508 $ 2,163 Stock Options A summary of stock option activity and related information through June 30, 2023 follows: Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, December 31, 2022 351,709 $ 49.15 6.94 Granted 95,900 1.04 Forfeited/Cancelled (26,045) 49.62 Balance, June 30, 2023 421,564 $ 38.17 7.25 Vested or expected to vest at June 30, 2023 421,564 $ 38.17 7.25 Exercisable at June 30, 2023 265,979 $ 50.48 6.14 The aggregate intrinsic value of options exercisable as of June 30, 2023 was zero, based on the difference between the Company’s closing stock price of $0.8810 and the exercise price of each stock option. At June 30, 2023, there was $2.0 million of total unrecognized compensation expense related to unvested options that will be recognized over the weighted average remaining vesting period of 1.61 years. 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 common 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 common stock. The per-share weighted-average grant date fair value of the options granted to employees and directors during the six months ended June 30, 2023 and 2022 was estimated at $0.81 and $9.19 per share, respectively, on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions: June 30, 2023 2022 Expected term of options (in years) 5.5 5.7 Risk-free interest rate 3.9 % 2.7 % Expected volatility 105.5 % 97.8 % Dividend yield — % — % 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. The following is a summary of changes in the status of non-vested RSUs during the six months ended June 30, 2023: Weighted Average Number of Grant Date Awards Fair Value Non-vested at December 31, 2022 366,777 $ 10.43 Granted 500,000 1.78 Vested (2,750) 24.00 Forfeited/Cancelled (82,792) 5.73 Non-vested at June 30, 2023 781,235 $ 5.34 For the six months ended June 30, 2023, the Company recorded $0.7 million, in stock-based compensation expense related to RSUs, which is reflected in the consolidated statements of operations and comprehensive loss. As of June 30, 2023, there was $2.94 million of total unrecognized compensation expense related to unvested RSUs that will be recognized over the weighted average remaining period of 2.32 years. Shares Available for Future Grant At June 30, 2023, the Company has the following shares available to be granted under its equity incentive plans: Inducement 2023 Plan Plan Available at December 31, 2022 404,807 12,000 Authorized 1,287,958 — Granted (595,900) — Shares withheld for taxes not issued 722 — Forfeited/Cancelled 108,837 — Available at June 30, 2023 1,206,424 12,000 Shares Reserved for Future Issuance At June 30, 2023, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 317,664 Stock options outstanding under 2023 Plan 95,900 Restricted stock units outstanding under 2013 Plan 781,235 Stock options outstanding under Inducement Plan 8,000 Warrants outstanding 3,145,394 Total shares of common stock reserved for future issuance 4,348,193 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 7. 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. (“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 consolidated statements of operations and comprehensive loss as other income (expense). Supplemental balance sheet information related to leases was as follows (in thousands): June 30, 2023 December 31, 2022 Operating leases: Operating lease right-of-use assets $ 3,955 $ 4,224 Other current lease liabilities 945 890 Operating lease liabilities 4,934 5,419 Total operating lease liabilities $ 5,879 $ 6,309 Finance leases: Property and equipment, at cost $ 29 $ 29 Accumulated depreciation (8) (4) Property and equipment, net 21 25 Other current lease liabilities 9 9 Other long-term liabilities 12 17 Total finance lease liabilities $ 21 $ 26 The components of lease expense were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Operating lease costs: Operating lease expense $ 349 $ 336 $ 746 $ 663 Other income (347) (344) (697) (659) Total operating lease costs $ 2 $ (8) $ 49 $ 4 Finance lease costs: Amortization of right-of-use assets 2 1 5 3 Total finance lease costs $ 2 $ 1 $ 5 $ 3 Supplemental cash flow information related to leases was as follows (in thousands): Six Months Ended June 30, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (209) $ (151) Financing cash flows from finance leases (5) (3) Operating lease liabilities will mature, as follows (in thousands): s Operating Leases Financing Leases 2023 (July 1 - December 31) 718 5 2024 1,450 11 2025 1,474 7 2026 1,498 — 2027 1,523 — 2028 and beyond 640 — Total minimum lease payments $ 7,303 $ 23 Less: imputed interest (1,424) (2) Lease liability $ 5,879 $ 21 Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2023 (July 1 - December 31) 571 2024 996 Total minimum lease payments $ 1,567 Lease term and discount rates are as follows: Six Months Ended June 30, 2023 2022 Weighted average remaining lease term (years) Operating leases 5 6 Finance leases 2 — Weighted average discount rate Operating leases 9.2% 9.2% Finance leases 6.5% 6.5% |
Product Revenue
Product Revenue | 6 Months Ended |
Jun. 30, 2023 | |
Revenue. | |
Product Revenue | 8. 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. Sales-Related Deductions The following table presents a roll forward of the major categories of sales-related deductions included in trade receivable allowances for the six months ended June 30, 2023 (in thousands): Sales Discounts Chargebacks Fee for Service Balance, January 1, 2023 $ 1 $ 30 $ 36 Adjustment related to prior period sales — 6 (28) Balance, June 30, 2023 $ 1 $ 36 $ 8 |
License Revenue
License Revenue | 6 Months Ended |
Jun. 30, 2023 | |
License Revenue. | |
License Revenue | 9. 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. In May 2023, the Company received a milestone payment of $3.0 million (less applicable withholding taxes $0.3 million), that became payable by Nhwa upon regulatory approval of OLINVYK in China. The Company is eligible to receive 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. This royalty is required to be used by the Company to repay its obligations under the Loan Agreement. As part of the license agreement with Nhwa, 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 formed a Joint Manufacturing and Commercialization Committee to provide overall coordination and oversight of the manufacture and commercialization of OLINVYK in China. For the three and six months ended June 30, 2023 and 2022, license revenue in the accompanying consolidated statements of operations and comprehensive loss is comprised of the following: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Pharmbio Korea Inc. $ — $ — $ — $ 20 Jiangsu Nhwa Pharmaceutical Co. Ltd. 3,000 — 3,000 — Total license revenues $ 3,000 $ — $ 3,000 $ 20 License revenue recorded for the six months ended June 30, 2023 related to the milestone payment that became payable by Nhwa upon regulatory approval of OLINVYK in China. License revenue for the six months ended June 30, 2022 related to materials shipped to Pharmbio to support the development of oliceridine efforts in South Korea |
Net Loss Per Common Share
Net Loss Per Common Share | 6 Months Ended |
Jun. 30, 2023 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 10. 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): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Basic and diluted net loss per common share calculation: Net loss $ (8,012) $ (14,981) $ (15,831) $ (31,370) Weighted average common shares outstanding 11,580,128 6,621,083 10,592,586 6,620,942 Net loss per share of common stock - basic and diluted $ (0.69) $ (2.26) $ (1.49) $ (4.74) The following outstanding securities at June 30, 2023 and 2022 have been excluded from the computation of diluted weighted shares outstanding, as they would have been anti-dilutive: June 30, 2023 2022 Options outstanding 421,564 534,662 RSUs outstanding 781,235 212,394 Warrants outstanding 3,145,394 211,014 Total 4,348,193 958,070 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events | |
Subsequent Events | 11. Subsequent Events On August 3, 2023, Vanguard exercised its option to extend its sublease term, and the Company and Vanguard agreed to further extend this sublease through May 2028. With the current extension to May 2028, Vanguard’s sublease is coterminous with the Company’s lease term. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the ASC and Accounting Standards Updates, or ASUs, of the FASB. The Company’s functional currency is the U.S. dollar. The consolidated financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s consolidated balance sheets as of June 30, 2023, its results of operations and its comprehensive loss for the six months ended June 30, 2023 and 2022, its consolidated statements of stockholders’ equity for the period from January 1, 2023 to June 30, 2023 and for the period January 1, 2022 to June 30, 2022, and its consolidated statements of cash flows for the six months ended June 30, 2023 and 2022. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and accompanying notes included in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2022. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. The financial data and other information disclosed in these notes related to the six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. |
Principles of Consolidation | Principles of Consolidation In connection with the royalty-based financing agreement disclosed in Note 5, 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 June 30, 2023. All significant intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of consolidated 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. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. |
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, at June 30, 2023, 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. |
Product Revenue | Product Revenue The Company accounts for product revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606). The Company performs the following five steps to recognize revenue under ASC 606: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue when it believes that it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services that will be transferred to the customer. The Company sells OLINVYK to wholesalers in the US (collectively, “customers”). These customers subsequently resell the Company’s products generally to hospitals, ambulatory surgical centers and other purchasers of OLINVYK. The Company recognizes revenue from OLINVYK sales at the point customers obtain control of the product, which generally occurs upon delivery. The transaction price that is recognized as revenue for products includes an estimate of variable consideration which is described below. |
Variable Consideration | 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 based on the probability that a significant reversal in the amount of cumulative revenue may occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. Actual amounts of consideration ultimately received may vary from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect product sales and earnings in the period such variances become known. |
Distributor Chargebacks | 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. |
Prompt Payment (Cash) Discounts | 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. |
Distribution Service Fees | 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. |
Product Returns | Product Returns Generally, the Company’s customers have the right to return any unopened product during the eighteen (18) month period beginning six (6) months prior to the labeled expiration date and ending twelve (12) months after the labeled expiration date. Since the Company did not have a history of OLINVYK returns when the product was launched, the Company estimated returns based on industry data for comparable products in the market. As the Company sells OLINVYK and establishes historical sales over a longer period of time, the Company places more reliance on historical purchasing, demand, return patterns of its customers and the amount of OLINVYK held by wholesalers, when evaluating reserves for product returns. OLINVYK has a forty-eight (48) month shelf life. 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. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value | |
Schedule of cash, cash equivalents, marketable securities and restricted cash | June 30, Quoted Prices in Active Markets Significant Other Observable Inputs Unobservable Inputs Description: 2023 (Level 1) (Level 2) (Level 3) Assets: Cash $ 1,490 $ 1,490 $ — $ — Money Market Funds 26,607 26,607 — — Restricted Cash 540 540 — — Total assets measured and recorded at fair value $ 28,637 $ 28,637 $ — $ — Liabilities: Warrant Liability 1,779 — — 1,779 Total liabilities measured and recorded at fair value $ 1,779 $ — $ — $ 1,779 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 — — 5,483 Total liabilities measured and recorded at fair value $ 5,483 $ — $ — $ 5,483 (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. |
Schedule of common stock warrants outstanding | As of June 30, 2023, the Company had the following common stock warrants outstanding: Classification Warrants Exercise Price Expiration Date July 2022 Offering Liability 320,000 $6.58 12/28/2027 November 2022 Offering Liability 2,614,380 2.95 11/18/2027 R-Bridge warrants Equity 200,000 20.50 4/14/2025 Other warrants Equity 11,014 31.25 – 265.48 1/29/2024 – 3/31/2027 3,145,394 |
Registered direct offering | |
Fair Value | |
Schedule of assumptions used to estimate fair value of common stock warrant liability using Level 3 inputs | June 30, December 31, 2023 2022 Expected term of warrants (in years) 4.1 4.6 Risk-free interest rate 4.3 % 4.0 % Expected volatility 123.9 % 108.9 % Dividend yield — % — % |
Schedule of rollforward of the Common Stock Warrant liability | The following is a roll forward of the July 2022 Offering common stock warrant liability (in thousands): Balance, December 31, 2022 $ 259 Change in fair value (104) Balance, June 30, 2023 $ 155 |
November 2022 Equity Offering | |
Fair Value | |
Schedule of assumptions used to estimate fair value of common stock warrant liability using Level 3 inputs | June 30, 2023 December 31, 2022 Expected term of warrants (in years) 4.4 4.9 Risk-free interest rate 4.2 % 4.0 % Expected volatility 126.5 % 106.1 % Dividend yield — % — % |
Schedule of rollforward of the Common Stock Warrant liability | The following is a roll forward of the November 2022 Offering common stock warrant liability (in thousands): Warrant Liability Balance, December 31, 2022 $ 5,224 Change in fair value (1,599) Exercise of pre-funded common stock warrants (2,001) Balance, June 30, 2023 $ 1,624 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Inventories | |
Schedule of Inventories | Inventory consists of the following (in thousands): June 30, 2023 December 31, 2022 Finished goods $ 901 $ 3,111 Inventory Valuation Adjustment — (2,205) Total Inventories $ 901 $ 906 |
Loan Payable (Tables)
Loan Payable (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Loan Payable. | |
Schedule of impact of the Loan Agreement on the Company's consolidated balance sheet | The following table summarizes the impact of the Loan Agreement on the Company’s consolidated balance sheet as follows (in thousands): June 30, 2023 Principal and accreted interest $ 15,670 Unamortized debt discount (1,494) Loans payable, net $ 14,176 |
Stock Compensation (Tables)
Stock Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Stock Compensation | |
Schedule of share-based compensation expense recognized | The estimated grant date fair value of the Company’s share-based awards is amortized on a straight-line basis over the awards’ service periods. Share based compensation expense recognized was as follows (in thousands): Six Months Ended June 30, 2023 2022 Research and development $ 295 $ 494 Selling, general and administrative 1,213 1,655 Cost of goods sold — 14 Total stock-based compensation $ 1,508 $ 2,163 |
Summary of stock option activity | Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, December 31, 2022 351,709 $ 49.15 6.94 Granted 95,900 1.04 Forfeited/Cancelled (26,045) 49.62 Balance, June 30, 2023 421,564 $ 38.17 7.25 Vested or expected to vest at June 30, 2023 421,564 $ 38.17 7.25 Exercisable at June 30, 2023 265,979 $ 50.48 6.14 |
Schedule of weighted-average assumptions: | June 30, 2023 2022 Expected term of options (in years) 5.5 5.7 Risk-free interest rate 3.9 % 2.7 % Expected volatility 105.5 % 97.8 % Dividend yield — % — % |
Schedule of changes in the status of non-vested RSU | Weighted Average Number of Grant Date Awards Fair Value Non-vested at December 31, 2022 366,777 $ 10.43 Granted 500,000 1.78 Vested (2,750) 24.00 Forfeited/Cancelled (82,792) 5.73 Non-vested at June 30, 2023 781,235 $ 5.34 |
Schedule of shares available to be granted under equity incentive plans | At June 30, 2023, the Company has the following shares available to be granted under its equity incentive plans: Inducement 2023 Plan Plan Available at December 31, 2022 404,807 12,000 Authorized 1,287,958 — Granted (595,900) — Shares withheld for taxes not issued 722 — Forfeited/Cancelled 108,837 — Available at June 30, 2023 1,206,424 12,000 |
Schedule of shares of common stock reserved/available | At June 30, 2023, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 317,664 Stock options outstanding under 2023 Plan 95,900 Restricted stock units outstanding under 2013 Plan 781,235 Stock options outstanding under Inducement Plan 8,000 Warrants outstanding 3,145,394 Total shares of common stock reserved for future issuance 4,348,193 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies. | |
Schedule of balance sheet information related to leases | Supplemental balance sheet information related to leases was as follows (in thousands): June 30, 2023 December 31, 2022 Operating leases: Operating lease right-of-use assets $ 3,955 $ 4,224 Other current lease liabilities 945 890 Operating lease liabilities 4,934 5,419 Total operating lease liabilities $ 5,879 $ 6,309 Finance leases: Property and equipment, at cost $ 29 $ 29 Accumulated depreciation (8) (4) Property and equipment, net 21 25 Other current lease liabilities 9 9 Other long-term liabilities 12 17 Total finance lease liabilities $ 21 $ 26 |
Schedule of components of lease expense | The components of lease expense were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Operating lease costs: Operating lease expense $ 349 $ 336 $ 746 $ 663 Other income (347) (344) (697) (659) Total operating lease costs $ 2 $ (8) $ 49 $ 4 Finance lease costs: Amortization of right-of-use assets 2 1 5 3 Total finance lease costs $ 2 $ 1 $ 5 $ 3 |
Schedule of supplemental cash flow information | Supplemental cash flow information related to leases was as follows (in thousands): Six Months Ended June 30, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (209) $ (151) Financing cash flows from finance leases (5) (3) |
Schedule of maturities of operating lease liabilities | Operating lease liabilities will mature, as follows (in thousands): s Operating Leases Financing Leases 2023 (July 1 - December 31) 718 5 2024 1,450 11 2025 1,474 7 2026 1,498 — 2027 1,523 — 2028 and beyond 640 — Total minimum lease payments $ 7,303 $ 23 Less: imputed interest (1,424) (2) Lease liability $ 5,879 $ 21 |
Schedule of maturities of financing lease liabilities | Operating lease liabilities will mature, as follows (in thousands): s Operating Leases Financing Leases 2023 (July 1 - December 31) 718 5 2024 1,450 11 2025 1,474 7 2026 1,498 — 2027 1,523 — 2028 and beyond 640 — Total minimum lease payments $ 7,303 $ 23 Less: imputed interest (1,424) (2) Lease liability $ 5,879 $ 21 |
Schedule of expected sublease inflows | Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2023 (July 1 - December 31) 571 2024 996 Total minimum lease payments $ 1,567 |
Schedule of weighted average lease term and discount rates | Six Months Ended June 30, 2023 2022 Weighted average remaining lease term (years) Operating leases 5 6 Finance leases 2 — Weighted average discount rate Operating leases 9.2% 9.2% Finance leases 6.5% 6.5% |
Product Revenue (Tables)
Product Revenue (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Revenue. | |
Schedule of major categories of sales-related deductions included in trade receivable allowances | Sales Discounts Chargebacks Fee for Service Balance, January 1, 2023 $ 1 $ 30 $ 36 Adjustment related to prior period sales — 6 (28) Balance, June 30, 2023 $ 1 $ 36 $ 8 |
License Revenue (Tables)
License Revenue (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Revenue. | |
Schedule of license revenue | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Pharmbio Korea Inc. $ — $ — $ — $ 20 Jiangsu Nhwa Pharmaceutical Co. Ltd. 3,000 — 3,000 — Total license revenues $ 3,000 $ — $ 3,000 $ 20 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Basic and diluted net loss per common share calculation: Net loss $ (8,012) $ (14,981) $ (15,831) $ (31,370) Weighted average common shares outstanding 11,580,128 6,621,083 10,592,586 6,620,942 Net loss per share of common stock - basic and diluted $ (0.69) $ (2.26) $ (1.49) $ (4.74) |
Schedule of outstanding securities excluded from the computation of diluted weighted shares outstanding as they would have been anti-dilutive | June 30, 2023 2022 Options outstanding 421,564 534,662 RSUs outstanding 781,235 212,394 Warrants outstanding 3,145,394 211,014 Total 4,348,193 958,070 |
Organization and Description _2
Organization and Description of the Business (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Jun. 30, 2023 USD ($) segment | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Organization and Description of the Business | |||||||
Number of operating segments | segment | 1 | ||||||
Accumulated deficit | $ 563,603 | $ 563,603 | $ 547,772 | ||||
Net loss | $ 8,012 | $ 7,819 | $ 14,981 | $ 16,389 | $ 15,831 | $ 31,370 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 6 Months Ended |
Jun. 30, 2023 subsidiary | |
Summary of Significant Accounting Policies | |
Number of wholly owned subsidiaries | 3 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Dec. 31, 2022 | |
Liabilities | ||
Transfers between Level 2 and Level 3 | $ 0 | |
Fair Value | ||
Assets | ||
Cash | 1,490 | $ 9,651 |
Restricted cash | 540 | 1,960 |
Total | 28,637 | 40,280 |
Liabilities | ||
Liabilities | 1,779 | 5,483 |
Warrants | Fair Value | ||
Liabilities | ||
Liabilities | 1,779 | 5,483 |
Money market mutual funds | Fair Value | ||
Assets | ||
Investments | 26,607 | 28,669 |
Level 1 | ||
Assets | ||
Cash | 1,490 | 9,651 |
Restricted cash | 540 | 1,960 |
Total | 28,637 | 40,280 |
Level 1 | Money market mutual funds | ||
Assets | ||
Investments | 26,607 | 28,669 |
Level 3 | Fair Value | ||
Liabilities | ||
Liabilities | 1,779 | 5,483 |
Level 3 | Warrants | Fair Value | ||
Liabilities | ||
Liabilities | $ 1,779 | $ 5,483 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Registered Direct Stock Offering and Concurrent Warrant Issuance (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 USD ($) $ / shares shares | Mar. 31, 2023 USD ($) | Jun. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 | |
Fair Value | ||||
Warrants to purchase shares of common stock | shares | 3,145,394 | 3,145,394 | ||
Net proceeds from the offering | $ 6,504 | |||
Exercise of pre-funded common stock warrants | $ (434) | $ (1,569) | ||
Registered direct offering | ||||
Fair Value | ||||
Warrants to purchase shares of common stock | shares | 320,000 | 320,000 | ||
Exercise price (in dollars per share) | $ / shares | $ 6.58 | $ 6.58 | ||
Beginning balance | 259 | $ 259 | ||
Change in fair value | (104) | |||
Ending balance | $ 155 | $ 155 | ||
Registered direct offering | Common Stock Warrants | Level 3 | Estimated remaining term | ||||
Fair Value | ||||
Warrant liability measurement input | 4.1 | 4.1 | 4.6 | |
Registered direct offering | Common Stock Warrants | Level 3 | Risk-free interest rate | ||||
Fair Value | ||||
Warrant liability measurement input | 4.3 | 4.3 | 4 | |
Registered direct offering | Common Stock Warrants | Level 3 | Volatility | ||||
Fair Value | ||||
Warrant liability measurement input | 123.9 | 123.9 | 108.9 | |
November 2022 Equity Offering | Common Stock Warrants | ||||
Fair Value | ||||
Beginning balance | $ 5,224 | $ 5,224 | ||
Change in fair value | (1,599) | |||
Exercise of pre-funded common stock warrants | (2,001) | |||
Ending balance | $ 1,624 | $ 1,624 | ||
November 2022 Equity Offering | Common Stock Warrants | Level 3 | Estimated remaining term | ||||
Fair Value | ||||
Warrant liability measurement input | 4.4 | 4.4 | 4.9 | |
November 2022 Equity Offering | Common Stock Warrants | Level 3 | Risk-free interest rate | ||||
Fair Value | ||||
Warrant liability measurement input | 4.2 | 4.2 | 4 | |
November 2022 Equity Offering | Common Stock Warrants | Level 3 | Volatility | ||||
Fair Value | ||||
Warrant liability measurement input | 126.5 | 126.5 | 106.1 | |
November 2022 Equity Offering Expiring 2027 | ||||
Fair Value | ||||
Warrants to purchase shares of common stock | shares | 2,614,380 | 2,614,380 | ||
Exercise price (in dollars per share) | $ / shares | $ 2.95 | $ 2.95 | ||
R-Bridge Financing | ||||
Fair Value | ||||
Warrants to purchase shares of common stock | shares | 200,000 | 200,000 | ||
Exercise price (in dollars per share) | $ / shares | $ 20.50 | $ 20.50 | ||
Other Warrants | ||||
Fair Value | ||||
Warrants to purchase shares of common stock | shares | 11,014 | 11,014 | ||
Other Warrants | Minimum | ||||
Fair Value | ||||
Exercise price (in dollars per share) | $ / shares | $ 31.25 | $ 31.25 | ||
Other Warrants | Maximum | ||||
Fair Value | ||||
Exercise price (in dollars per share) | $ / shares | $ 265.48 | $ 265.48 |
Inventories - Schedule Of Inven
Inventories - Schedule Of Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Inventories | ||
Finished goods | $ 901 | $ 3,111 |
Inventory Valuation Adjustment | (2,205) | |
Total Inventories | $ 901 | $ 906 |
Loan Payable (Details)
Loan Payable (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Apr. 30, 2022 USD ($) tranche $ / shares shares | Jun. 30, 2023 USD ($) shares | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) shares | Jun. 30, 2022 USD ($) | |
Long Term Debt | |||||
Warrants to purchase shares of common stock | shares | 3,145,394 | 3,145,394 | |||
Number of shares that can be purchased upon exercise of warrants (in shares) | shares | 3,145,394 | 3,145,394 | |||
Interest expense | $ 1,122 | $ 325 | $ 1,568 | $ 325 | |
R-Bridge Financing | Royalty Based Loan Agreement | |||||
Long Term Debt | |||||
Maximum amount of borrowings under term loan agreement | $ 40,000 | ||||
Debt number of tranches | tranche | 3 | ||||
Proceeds | 15,670 | 15,670 | |||
Unamoritized debt discount | (1,494) | (1,494) | |||
Loans payable, net | 14,176 | 14,176 | |||
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 | ||||
Amount placed in interest reserve account | 2,000 | ||||
Amount transferred to prepay future interest payments | $ 1,000 | ||||
R-Bridge Financing | Royalty Based Loan Agreement | Minimum | |||||
Long Term Debt | |||||
Control premium, amount if triggered | 10,000 | ||||
R-Bridge Financing | Royalty Based Loan Agreement | Maximum | |||||
Long Term Debt | |||||
Control premium, amount if triggered | 20,000 | ||||
R-Bridge Financing | Royalty Based Loan Agreement - First Tranche | |||||
Long Term Debt | |||||
Proceeds from royalty-based loan agreement | $ 15,000 | ||||
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 | ||||
Number of shares that can be purchased upon exercise of warrants (in shares) | shares | 200,000 | ||||
Interest expense | 1,600 | ||||
Amortization of debt discount | $ 100 | ||||
R-Bridge Financing | Royalty Based Loan Agreement - Second Tranche | |||||
Long Term Debt | |||||
Commercialization milestone payments | $ 10,000 | ||||
R-Bridge Financing | Royalty Based Loan Agreement - Third Tranche | CHINA | |||||
Long Term Debt | |||||
Milestone payment upon first commercial sale in China | $ 15,000 |
Stock Compensation - Share base
Stock Compensation - Share based compensation expense (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Equity Incentive Plans | ||
Stock-based compensation | $ 1,508 | $ 2,163 |
Research and Development Expense | ||
Equity Incentive Plans | ||
Stock-based compensation | 295 | 494 |
General and Administrative Expense | ||
Equity Incentive Plans | ||
Stock-based compensation | $ 1,213 | 1,655 |
Cost of goods sold | ||
Equity Incentive Plans | ||
Stock-based compensation | $ 14 |
Stock compensation - Stock opti
Stock compensation - Stock option activity (Details) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Balance at the beginning of the period (in shares) | 351,709 | |
Granted (in shares) | 95,900 | |
Forfeited/Cancelled (in shares) | (26,045) | |
Balance at the end of the period (in shares) | 421,564 | 351,709 |
Vested or expected to vest at the end of the period (in shares) | 421,564 | |
Exercisable at the end of the period (in shares) | 265,979 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ 49.15 | |
Granted (in dollars per share) | 1.04 | |
Forfeited/Cancelled (in dollars per share) | 49.62 | |
Balance at the end of the period (in dollars per share) | 38.17 | $ 49.15 |
Vested or expected to vest at the end of the period (in dollars per share) | 38.17 | |
Exercisable at the end of the period (in dollars per share) | $ 50.48 | |
Weighted Average Remaining Contractual Term | ||
Options Outstanding at the end of the period | 7 years 3 months | 6 years 11 months 8 days |
Vested or expected to vest at the end of the period | 7 years 3 months | |
Exercisable at the end of the period | 6 years 1 month 20 days | |
Closing price of Company's stock (in dollars per share) | $ 0.8810 |
Stock Compensation - Options ot
Stock Compensation - Options other Info (Details) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Options outstanding | ||
Closing price of Company's stock (in dollars per share) | $ 0.8810 | |
Employee Stock Option | ||
Options outstanding | ||
Unrecognized compensation expense | $ 2 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 1 year 7 months 9 days | |
Per-share weighted-average grant date fair value of options granted (in dollars per share) | $ 0.81 | $ 9.19 |
Employee Stock Option | Weighted-average | ||
Weighted-average assumptions: | ||
Expected term of options (in years) | 5 years 6 months | 5 years 8 months 12 days |
Risk-free interest rate (as a percent) | 3.90% | 2.70% |
Expected volatility (as a percent) | 105.50% | 97.80% |
Stock compensation - Non-vested
Stock compensation - Non-vested RSUs (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Weighted Average Grant Date Fair Value | ||
Stock-based compensation | $ 1,508 | $ 2,163 |
Restricted Stock Units | ||
Number of Shares | ||
Non-vested at beginning of period (in shares) | 366,777 | |
Granted (in shares) | 500,000 | |
Vested (in shares) | (2,750) | |
Forfeited/Cancelled (in shares) | (82,792) | |
Non-vested at end of period (in shares) | 781,235 | |
Weighted Average Grant Date Fair Value | ||
Non-vested at beginning of period (in dollars per share) | $ 10.43 | |
Granted (in dollars per share) | 1.78 | |
Vested (in dollars per share) | 24 | |
Forfeited (in dollars per share) | 5.73 | |
Non-vested at end of period (in dollars per share) | $ 5.34 | |
Stock-based compensation | $ 700 | |
Unrecognized compensation expense | $ 2,940 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 2 years 3 months 25 days |
Stock Compensation - Shares Res
Stock Compensation - Shares Reserved for Future Grant and Issuance (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Dec. 31, 2022 | |
Shares Reserved for Future Issuance | ||
Stock options outstanding (in shares) | 421,564 | 351,709 |
Warrants outstanding (in shares) | 3,145,394 | |
Total shares of common stock reserved for future issuance (in shares) | 4,348,193 | |
Inducement Plan | ||
Shares Available for Future Grant | ||
Balance at the beginning of the period (in shares) | 12,000 | |
Balance at the end of the period (in shares) | 12,000 | |
Shares Reserved for Future Issuance | ||
Shares available for future issuance (in shares) | 12,000 | 12,000 |
2023 Plan | ||
Shares Available for Future Grant | ||
Balance at the beginning of the period (in shares) | 404,807 | |
Authorized (in shares) | 1,287,958 | |
Granted (in shares) | (595,900) | |
Shares withheld for taxes not issued (in shares) | 722 | |
Forfeited/Cancelled (in shares) | 108,837 | |
Balance at the end of the period (in shares) | 1,206,424 | |
Shares Reserved for Future Issuance | ||
Shares available for future issuance (in shares) | 1,206,424 | 404,807 |
Employee Stock Option | 2013 plan | ||
Shares Reserved for Future Issuance | ||
Stock options outstanding (in shares) | 317,664 | |
Employee Stock Option | Inducement Plan | ||
Shares Reserved for Future Issuance | ||
Stock options outstanding (in shares) | 8,000 | |
Employee Stock Option | 2023 Plan | ||
Shares Reserved for Future Issuance | ||
Stock options outstanding (in shares) | 95,900 | |
Restricted Stock Units | 2013 plan | ||
Shares Reserved for Future Issuance | ||
Stock options outstanding (in shares) | 781,235 |
Commitments and Contingencies -
Commitments and Contingencies - Leases (Details) - Chesterbrook, Pennsylvania | Oct. 02, 2020 | Oct. 11, 2018 ft² $ / ft² | Jun. 30, 2023 USD ($) |
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 | ft² | 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 | Jun. 30, 2023 | Dec. 31, 2022 |
Leases | ||
Operating lease right-of-use assets | $ 3,955 | $ 4,224 |
Operating lease liabilities - Current | $ 945 | $ 890 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Lease Liability Current | Lease Liability Current |
Operating lease liabilities - Noncurrent | $ 4,934 | $ 5,419 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease Liability Noncurrent | Lease Liability Noncurrent |
Lease Liability | $ 5,879 | $ 6,309 |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | Lease Liability Current, Lease Liability Noncurrent | Lease Liability Current, Lease Liability Noncurrent |
Property and equipment, net | $ 1,343 | $ 1,488 |
Finance lease liabilities - Current | $ 9 | $ 9 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Lease Liability Current | Lease Liability Current |
Finance lease liabilities - Noncurrent | $ 12 | $ 17 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease Liability Noncurrent | Lease Liability Noncurrent |
Lease Liability | $ 21 | $ 26 |
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 | $ 29 |
Accumulated depreciation | (8) | (4) |
Property and equipment, net | $ 21 | $ 25 |
Commitments and Contingencies_3
Commitments and Contingencies - Components of lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating lease costs: | ||||
Operating lease rental expense | $ 349 | $ 336 | $ 746 | $ 663 |
Other income | (347) | (344) | (697) | (659) |
Total operating lease costs | 2 | (8) | 49 | 4 |
Finance lease costs: | ||||
Amortization of right-of-use assets | 2 | 1 | 5 | 3 |
Total finance lease costs | $ 2 | $ 1 | $ 5 | $ 3 |
Commitments and Contingencies_4
Commitments and Contingencies - Cash flow information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Commitments and Contingencies. | ||
Operating cash flows from operating leases | $ (209) | $ (151) |
Financing cash flows from finance leases | $ (5) | $ (3) |
Commitments and Contingencies_5
Commitments and Contingencies - Lease liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Operating Leases | ||
2023 (July 1 - December 31) | $ 718 | |
2024 | 1,450 | |
2025 | 1,474 | |
2026 | 1,498 | |
2027 | 1,523 | |
2028 and beyond | 640 | |
Total minimum lease payments | 7,303 | |
Interest Expense | (1,424) | |
Lease Liability | 5,879 | $ 6,309 |
Financing Leases | ||
2023 (July 1 - December 31) | 5 | |
2024 | 11 | |
2025 | 7 | |
Total minimum lease payments | 23 | |
Interest Expense | (2) | |
Lease Liability | 21 | $ 26 |
Sublease | ||
2023 (July 1 - December 31) | 571 | |
2024 | 996 | |
Total minimum lease payments | $ 1,567 |
Commitments and Contingencies_6
Commitments and Contingencies - Lease term and discount rates (Details) | Jun. 30, 2023 | Jun. 30, 2022 |
Commitments and Contingencies. | ||
Weighted average remaining lease term - Operating leases | 5 years | 6 years |
Weighted average remaining lease term - Finance leases | 2 years | |
Weighted average discount rate - Operating leases | 9.20% | 9.20% |
Weighted average discount rate - Finance leases | 6.50% | 6.50% |
Product Revenue (Details)
Product Revenue (Details) | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Sales Discounts | |
Balance | $ 1,000 |
Balance | 1,000 |
Chargebacks | |
Balance | 30,000 |
Adjustment related to prior period sales | 6,000 |
Balance | 36,000 |
Fee for Service | |
Balance | 36,000 |
Adjustment related to prior period sales | (28,000) |
Balance | 8,000 |
Outstanding accounts receivable | 22,000 |
Trade receivable allowance in excess of accounts receivable included with accrued expenses and other current liabilities | $ 23,000 |
License Revenue (Details)
License Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
May 31, 2023 | Aug. 31, 2020 | Jul. 31, 2018 | Jun. 30, 2018 | Jun. 30, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | |
Licensing Arrangements | |||||||
Total revenue | $ 3,000 | $ 3,000 | $ 20 | ||||
Pharmbio Korea Inc | |||||||
Licensing Arrangements | |||||||
Total revenue | $ 20 | ||||||
Pharmbio Korea Inc | Licensing agreements for development and commercialization | |||||||
Licensing Arrangements | |||||||
Upfront payment | $ 3,000 | ||||||
Commercialization milestone payments | $ 500 | ||||||
Time period for written notice to terminate license agreement | 180 days | ||||||
Pharmbio Korea Inc | Licensing agreements for development and commercialization | Minimum | |||||||
Licensing Arrangements | |||||||
Time period to form a committee prior to the anticipated date of regulatory approval | 6 months | ||||||
Pharmbio Korea Inc | Licensing agreements for development and commercialization | Maximum | |||||||
Licensing Arrangements | |||||||
Royalties on product sales, percentage | 20% | ||||||
Jiangsu Nhwa Pharmaceutical Co Ltd | |||||||
Licensing Arrangements | |||||||
Total revenue | $ 3,000 | $ 3,000 | |||||
Jiangsu Nhwa Pharmaceutical Co Ltd | Licensing agreements for development and commercialization | |||||||
Licensing Arrangements | |||||||
Upfront payment | $ 2,500 | ||||||
Withholding taxes | $ 300 | $ 300 | $ 300 | ||||
Time period for written notice to terminate license agreement | 180 days | ||||||
Milestone payment upon regulatory approval | $ 3,000 | ||||||
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 agreements for development and commercialization | |||||||
Licensing Arrangements | |||||||
Withholding taxes | $ 500 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Basic and diluted net loss per common share calculation: | ||||||
Net loss | $ (8,012) | $ (7,819) | $ (14,981) | $ (16,389) | $ (15,831) | $ (31,370) |
Weighted average common shares outstanding, basic (in shares) | 11,580,128 | 6,621,083 | 10,592,586 | 6,620,942 | ||
Weighted average common shares outstanding, diluted (in shares) | 11,580,128 | 6,621,083 | 10,592,586 | 6,620,942 | ||
Net loss per share of common stock, basic (in dollars per share) | $ (0.69) | $ (2.26) | $ (1.49) | $ (4.74) | ||
Net loss per share of common stock, diluted (in dollars per share) | $ (0.69) | $ (2.26) | $ (1.49) | $ (4.74) | ||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 4,348,193 | 958,070 | ||||
Employee Stock Option | ||||||
Basic and diluted net loss per common share calculation: | ||||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 421,564 | 534,662 | ||||
Restricted Stock Units | ||||||
Basic and diluted net loss per common share calculation: | ||||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 781,235 | 212,394 | ||||
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 | 211,014 |