Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 06, 2024 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
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, $0.001 par value | |
Trading Symbol | TRVN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 21,323,333 | |
Entity Central Index Key | 0001429560 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 16,367 | $ 32,975 |
Prepaid expenses and other current assets | 1,664 | 2,230 |
Total current assets | 18,031 | 35,205 |
Restricted cash | 540 | 540 |
Property and equipment, net | 1,018 | 1,195 |
Right-of-use lease assets | 3,354 | 3,665 |
Total assets | 22,943 | 40,605 |
Current liabilities: | ||
Accounts payable, net | 1,132 | 2,303 |
Accrued expenses and other current liabilities | 3,002 | 4,239 |
Lease liabilities | 1,072 | 1,012 |
Total current liabilities | 5,206 | 7,554 |
Loans payable, net | 31,527 | 30,809 |
Leases, net of current portion | 3,875 | 4,424 |
Warrant liability | 1,292 | 5,475 |
Total liabilities | 41,900 | 48,262 |
Stockholders' deficit: | ||
Preferred stock-$0.001 par value; 5,000,000 shares authorized, none issued or outstanding at June 30, 2024 and December 31, 2023 | ||
Common stock-$0.001 par value; 200,000,000 shares authorized at June 30, 2024 and December 31, 2023; 21,323,333 and 17,289,104 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 21 | 17 |
Additional paid-in capital | 581,652 | 580,387 |
Accumulated deficit | (600,630) | (588,061) |
Total stockholders' deficit | (18,957) | (7,657) |
Total liabilities and stockholders' deficit | $ 22,943 | $ 40,605 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Consolidated Balance Sheets (Unaudited) | ||
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) | 21,323,333 | 17,289,104 |
Common stock outstanding (in shares) | 21,323,333 | 17,289,104 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenue: | ||||
Total revenue | $ 325 | $ 3,021 | $ 345 | $ 3,027 |
Operating expenses: | ||||
Cost of goods sold | 103 | 88 | 191 | 214 |
Selling, general and administrative | 3,598 | 5,138 | 9,443 | 11,227 |
Research and development | 3,127 | 3,991 | 7,092 | 7,900 |
Total operating expenses | 6,828 | 9,217 | 16,726 | 19,341 |
Loss from operations | (6,503) | (6,196) | (16,381) | (16,314) |
Other income (expense): | ||||
Change in fair value of warrant liability | 1,822 | (763) | 4,183 | 1,703 |
Other income, net | 103 | 49 | 107 | 57 |
Interest income | 238 | 323 | 591 | 612 |
Interest expense | (521) | (1,122) | (1,034) | (1,568) |
Loss on foreign currency exchange | 1 | (3) | (4) | (21) |
Foreign income tax expense | (31) | (300) | (31) | (300) |
Total other income (expense), net | 1,612 | (1,816) | 3,812 | 483 |
Net loss | $ (4,891) | $ (8,012) | $ (12,569) | $ (15,831) |
Per share information: | ||||
Net loss per share of common stock, basic (in dollars per share) | $ (0.23) | $ (0.69) | $ (0.59) | $ (1.49) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.23) | $ (0.69) | $ (0.59) | $ (1.49) |
Weighted average common shares outstanding, basic (in shares) | 21,318,073 | 11,580,128 | 21,310,772 | 10,592,586 |
Weighted average common shares outstanding, diluted (in shares) | 21,318,073 | 11,580,128 | 21,310,772 | 10,592,586 |
Product revenue | ||||
Revenue: | ||||
Total revenue | $ 14 | $ 21 | $ 34 | $ 27 |
License and royalty revenues | ||||
Revenue: | ||||
Total revenue | $ 311 | $ 3,000 | $ 311 | $ 3,000 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' (Deficit) Equity (Unaudited) - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total |
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 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 806 | 806 | |||
Unrealized loss on marketable securities | (1) | (1) | |||
Exercise of pre-funded warrants | $ 1 | 1,568 | 1,569 | ||
Exercise of pre-funded warrants (in shares) | 1,230,380 | ||||
Net Income (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 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net Income (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 | ||||
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 | $ 1 | 433 | 434 | ||
Exercise of pre-funded warrants (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 Income (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 | ||||
Beginning Balance at Dec. 31, 2023 | $ 17 | 580,387 | (588,061) | $ (7,657) | |
Beginning Balance (in shares) at Dec. 31, 2023 | 17,289,104 | 17,289,104 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 681 | $ 681 | |||
Exercise of pre-funded warrants | $ 1 | (1) | |||
Exercise of pre-funded warrants (in shares) | 1,031,906 | ||||
Net Income (Loss) | (7,678) | (7,678) | |||
Ending Balance at Mar. 31, 2024 | $ 18 | 581,067 | (595,739) | (14,654) | |
Ending Balance (in shares) at Mar. 31, 2024 | 18,321,010 | ||||
Beginning Balance at Dec. 31, 2023 | $ 17 | 580,387 | (588,061) | $ (7,657) | |
Beginning Balance (in shares) at Dec. 31, 2023 | 17,289,104 | 17,289,104 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Net Income (Loss) | $ (12,569) | ||||
Ending Balance at Jun. 30, 2024 | $ 21 | 581,652 | (600,630) | $ (18,957) | |
Ending Balance (in shares) at Jun. 30, 2024 | 21,323,333 | 21,323,333 | |||
Beginning Balance at Mar. 31, 2024 | $ 18 | 581,067 | (595,739) | $ (14,654) | |
Beginning Balance (in shares) at Mar. 31, 2024 | 18,321,010 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 588 | 588 | |||
Exercise of pre-funded warrants | $ 2 | (2) | |||
Exercise of pre-funded warrants (in shares) | 1,748,000 | ||||
Transfer of shares held in abeyance | $ 1 | (1) | |||
Transfer of shares held in abeyance (in shares) | 1,234,380 | ||||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes (in shares) | 19,943 | ||||
Net Income (Loss) | (4,891) | (4,891) | |||
Ending Balance at Jun. 30, 2024 | $ 21 | $ 581,652 | $ (600,630) | $ (18,957) | |
Ending Balance (in shares) at Jun. 30, 2024 | 21,323,333 | 21,323,333 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' (Deficit) Equity (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 |
Common stock, par value (in dollars per share) | $ 0.001 | |||
Common Stock | ||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Operating activities: | ||
Net loss | $ (12,569) | $ (15,831) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 177 | 165 |
Stock-based compensation | 1,269 | 1,508 |
Noncash interest expense on loan | 718 | 746 |
Change in fair value of warrant liability | (4,183) | (1,703) |
Change in right-of-use asset | 311 | 269 |
Changes in operating assets and liabilities: | ||
Accounts receivable, prepaid expenses and other assets | 566 | (2,241) |
Inventories | 5 | |
Operating lease liabilities | (484) | (429) |
Accounts payable, accrued expenses and other liabilities | (2,408) | (613) |
Net cash used in operating activities | (16,603) | (18,124) |
Investing activities: | ||
Purchases of property and equipment | (20) | |
Net cash used in investing activities | (20) | |
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) | (5) |
Net cash (used in) provided by financing activities | (5) | 6,501 |
Net decrease in cash, cash equivalents and restricted cash | (16,608) | (11,643) |
Cash, cash equivalents and restricted cash-beginning of period | 33,515 | 40,280 |
Cash, cash equivalents and restricted cash-end of period | $ 16,907 | 28,637 |
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, 2024 | |
Organization and Description of the Business | |
Organization and Description of the Business | 1. Organization and Description of the Business Trevena, Inc., or the Company, is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients affected by central nervous system, or CNS, disorders. The Company operates in one segment and has its principal office in Chesterbrook, Pennsylvania. Since commencing operations in 2007, the Company has devoted substantially all of its financial resources and efforts to commercialization and research and development, including nonclinical studies and clinical trials. The Company has never been profitable. In late 2017, the Company submitted a new drug application, or NDA, for OLINVYK® (OLINVYK) injection, or OLINVYK, to the United States Food and Drug Administration, or the FDA. In August 2020, the FDA approved the NDA for OLINVYK and the Company initiated commercial launch of OLINVYK in the first quarter of 2021. In April 2024, we announced that OLINVYK remains available for purchase by customers, but that we are reducing commercial support for the product to preserve capital as we conduct a process to explore a range of strategic alternatives for OLINVYK. Since its inception, the Company has incurred losses and negative cash flows from operations. At June 30, 2024, the Company had an accumulated deficit of $600.6 million. The Company’s net loss was $12.6 million and $15.8 million for the six months ended June 30, 2024 and 2023 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, 2024 is not sufficient to fund operations for 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, including collaborations. 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. As a result, management concluded that such plans do not alleviate the substantial doubt. If the Company is unable to raise sufficient additional capital, consummate a strategic transaction or defer sufficient operating expenses, the Company may be compelled to reduce the scope of its operations and planned capital expenditures, to delist from the Nasdaq Capital Market (“Nasdaq”) or to wind down operations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
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, 2024, its results of operations and its comprehensive loss for the six months ended June 30, 2024 and 2023, its consolidated statements of stockholders’ equity for the period from January 1, 2024 to June 30, 2024 and for the period January 1, 2023 to June 30, 2023, and its consolidated statements of cash flows for the six months ended June 30, 2024 and 2023. 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, 2023. 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, 2024 and 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, 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 (which was later converted to a limited liability company, Trevena Royalty, LLC), 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, 2024. 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. Management used significant estimates in the following areas, among others: stock-based compensation expense, the determination of the fair value of stock-based awards, the fair value of common stock warrants, the accounting for research and development costs, accrued expenses, the recoverability of the Company’s net deferred tax assets and related valuation allowance, and the amortization of debt expenses. The financial data and other information disclosed in these notes are not necessarily indicative of the results to be expected for any future year or period. The Company bases its estimates on historical experience and also on assumptions that it believes are reasonable, however, actual results could significantly differ from those results. Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, restricted cash, accounts payable, and accrued expenses approximate their fair values, given their short-term nature. Additionally, the Company believes the carrying value of the loan payable approximates its fair value as the interest rate is reflective of the rate the Company could obtain on debt with similar terms and conditions. Certain of the Company’s common stock warrants are carried at fair value, as disclosed in Note 3. The Company has evaluated the estimated fair value of financial instruments using available market information and management’s estimates. The use of different market assumptions and/or estimation methodologies could have a significant effect on the estimated fair value amounts. See Note 3 for additional information. Product Revenue Product revenue is recognized at the point in time when our performance obligations with our customers have been satisfied. At contract inception, we determine if the contract is within the scope of ASC Topic 606 and then evaluate the contract using the following five steps: (i) identify the contract with the customer; (ii) identify the performance obligations; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue at the point in time when the Company satisfies a performance obligation. OLINVYK is sold to wholesalers in the US (collectively, “customers”). These customers subsequently resell OLINVYK generally to hospitals, ambulatory surgical centers and other purchasers of OLINVYK. We recognize revenue from OLINVYK sales at the point customers obtain control of the product, which generally occurs upon delivery. Revenue is recorded at the transaction price, which is the amount of consideration we expect to receive in exchange for transferring products to a customer. We determine the transaction price based on fixed consideration in our contractual agreements, which includes estimates of variable consideration which are more fully described below. The transaction price is allocated entirely to the performance obligation to provide pharmaceutical products. In determining the transaction price, a significant financing component does not exist since the timing from when we deliver product to when the customers pay for the product is less than one year and the customers do not pay for product in advance of the transfer of the product. Variable Consideration The Company includes an estimate of variable consideration in its transaction price at the time of sale when control of the product transfers to the customer. Variable consideration includes distributor chargebacks, prompt payment (cash) discounts, distribution service fees and product returns. The Company assesses whether or not an estimate of its variable consideration is constrained and has determined that the constraint does not apply, since it is probable that a significant reversal in the amount of cumulative revenue will not occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. The Company’s estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result in a change in the amount of total consideration it expects to receive. Distributor Chargebacks When a product that is subject to a contractual price agreement is sold to a third party, the difference between the price paid to the Company by the wholesaler and the price under the specific contract is charged back to the Company by the wholesaler. Utilizing this information, the Company estimates a chargeback percentage for each product and records an allowance for chargebacks as a reduction to revenue when the Company records sales of the products. We reduce the chargeback allowance when a chargeback request from a wholesaler is processed. Reserves for distributor chargebacks are included in accounts receivable, net on the consolidated balance sheet. Prompt Payment (Cash) Discounts The Company provides customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The Company’s prompt payment discount reserves are based on actual net sales and contractual discount rates. Reserves for prompt payment discounts are included in accounts receivable, net on the consolidated balance sheet. Distribution Service Fees The Company pays distribution service fees to its customers based on a fixed percentage of the product price. These fees are not in exchange for a distinct good or service and therefore are recognized as a reduction of the transaction price. The Company reserves for these fees based on actual net sales, contractual fee rates negotiated with the customer and the mix of the products in the distribution channel that remain subject to fees. Reserves for distribution service fees are included in accounts receivable, net on the consolidated balance sheet. Product Returns Generally, the Company’s customers have the right to return any unopened product during the eighteen (18) month period beginning six (6) months prior to the labeled expiration date and ending twelve (12) months after the labeled expiration date. The Company does not currently rely on industry data in its analysis of returns reserve. As the Company sold OLINVYK and established historical sales over a longer period of time (i.e., two to three years), the Company placed more reliance on historical purchasing, demand and return patterns of its customers when evaluating its 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, 2024 | |
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, 2024 and December 31, 2023 (in thousands): June 30, Quoted Prices in Active Markets Significant Other Observable Inputs Unobservable Inputs Description: 2024 (Level 1) (Level 2) (Level 3) Assets: Cash $ 951 $ 951 $ — $ — Money Market Funds 15,416 15,416 — — Restricted Cash 540 540 — — Total assets measured and recorded at fair value $ 16,907 $ 16,907 $ — $ — Liabilities: Warrant Liability 1,292 — — 1,292 Total liabilities measured and recorded at fair value $ 1,292 $ — $ — $ 1,292 December 31, Quoted Prices in Active Markets Significant Other Observable Inputs Unobservable Inputs Description: 2023 (Level 1) (Level 2) (Level 3) Assets: Cash $ 3,159 $ 3,159 $ — $ — Money Market Funds 29,816 29,816 — — Restricted Cash 540 540 — — Total assets measured and recorded at fair value $ 33,515 $ 33,515 $ — $ — Liabilities: Warrant Liability 5,475 — — 5,475 Total liabilities measured and recorded at fair value $ 5,475 $ — $ — $ 5,475 (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 December 2023 Equity Offering and Warrant Issuance The common stock warrants issued in connection with the Company’s private placement and warrant exercise transactions in December 2023 (collectively, the “December 2023 Offering”) 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 determined using Level 3 inputs and was estimated using a Black-Scholes Option Pricing Model. The assumptions used to estimate the fair value were as follows: June 30, 2024 December 31, 2023 Expected term of warrants (in years) 4.8 5.3 Risk-free interest rate 4.3 % 3.8 % Expected volatility 115.84 % 128.26 % Dividend yield — % — % The following is a roll forward of the December 2023 Offering common stock warrant liability (in thousands): Warrant Liability Balance, December 31, 2023 $ 5,475 Change in fair value (4,183) Balance, June 30, 2024 $ 1,292 Warrants As of June 30, 2024, the Company had the following common stock warrants outstanding: Classification Warrants Exercise Price Expiration Date December 2023 Offering Warrants Liability 8,648,666 0.70 4/19/2029 R-Bridge warrants Equity 200,000 20.50 4/14/2025 Other warrants Equity 4,114 90.38 - 265.48 9/19/2024 - 3/31/2027 8,852,780 |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2024 | |
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. 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, 2024 December 31, 2023 Finished goods $ 896 $ 896 Inventory Valuation Adjustment (896) (896) Total Inventories $ - $ - The Company recorded an inventory valuation adjustment of $0.9 million during the year ended December 31, 2023. The valuation adjustment was recorded to account for slow moving or obsolete inventory due to uncertainty of commercial activities and future expected OLINVYK sales. |
Loan Payable
Loan Payable | 6 Months Ended |
Jun. 30, 2024 | |
Loan Payable. | |
Loan Payable | 5. Loan Payable In April 2022, the Company, through its wholly owned subsidiary, Trevena SPV2 LLC (“SPV2”), entered into a royalty-based loan agreement (as amended, the “Loan Agreement”) with R-Bridge, pursuant to which the Company was eligible to receive up to $40.0 million in term loan borrowings (the “Royalty Financing”). Term loan borrowings under the Royalty Financing were to be advanced in three tranches. The first tranche of $15.0 million was advanced in April 2022. The second tranche of $10.0 million was to 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 became available upon the first commercial sale of OLINVYK in China which occurred in August 2023 and the Company elected to receive such proceeds. The following table summarizes the impact of the Loan Agreement on the Company’s consolidated balance sheet as follows (in thousands): June 30, 2024 Principal and accreted interest $ 32,851 Unamortized debt discount (1,324) Loans payable, net $ 31,527 The term loans bear interest at a rate per annum equal to 7.00% and will mature on the earlier of (i) the fifteen In April 2022, the Company placed $2.0 million into an interest reserve account in connection with the Loan Agreement. Payments of interest under the Loan Agreement are made quarterly from the royalty on the Company’s net sales of OLINVYK in the United States and proceeds from royalties from the Company’s license agreement with Nhwa. On each interest payment date, if the royalty payments received do not equal the total interest due for the respective quarter, the interest payment due will be paid from the interest reserve account. 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 of December 31, 2023, the prepaid interest had been reduced to $0.0 through interest expense incurred under the Loan Agreement. 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, 2024, there were no events of default pursuant to the Loan Agreement and the Company was in compliance with all covenants. Interest expense is imputed based on the estimated loan repayment period, which takes into consideration estimated future revenue in the United States and China. Changes in estimates are recognized prospectively and may have a material impact on liability balance. As of June 30, 2024, the effective interest rate was 5.8%. 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 from the date of issuance. In July 2024, these warrants were amended to reduce the exercise price to $0.28 and extend the exercise period to five years from the date of the Amendment (as defined below). The Company concluded the warrants were 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, 2024, the Company recognized interest expense of $0.7 million, of which $0.1 million pertained to the amortization of the debt discount. In July 2024, the Company amended the Loan Agreement (the “Amendment”) with respect to the second tranche for $10.0 million. In connection with the Amendment, the Company received a $2.0 million payment from R-Bridge and is eligible to receive an additional $8.0 million based upon achievement of certain US partnering and US commercial milestones for OLINVYK. In connection with the Amendment, (i) the ownership of certain OLINVYK Chinese IP that had been previously pledged to R-Bridge under the Royalty Financing was transferred to R-Bridge, (ii) warrants that had been previously issued to R-Bridge as part of the Royalty Financing were amended to reduce the exercise price and to extend the exercise period to five years from the date of the Amendment, (iii) the existing cap on US royalty payable to R-Bridge was increased from $10 million to $12 million (with no The accounting for the Loan Agreement requires the Company to make certain estimates and assumptions, particularly about future royalties under the license agreement with Nhwa and sales of OLINVYK in the United States and China. Such estimates and assumptions are utilized in determining the expected repayment term, amortization period of the debt discount, accretion of interest expense and classification between current and long-term portions of amounts outstanding. The Company amortizes the debt discount into interest expense over the expected term of the arrangement using the interest method based on projected cash flows. Similarly, the Company classifies as current debt for the Loan Agreement, amounts that are expected to be repaid during the succeeding twelve months after the reporting period end. However, the repayment of amounts due under the Loan Agreement is variable because the cash flows to be utilized for periodic payments is a function of amounts received by the Company with respect to the royalties and net product sales. Accordingly, the estimates of the magnitude and timing of amounts to be available for debt service are subject to significant variability and thus, subject to significant uncertainty. Therefore, these estimates and assumptions are likely to change, which may result in future adjustments to the portion of the debt that is classified as a current liability, the amortization of debt discount and the accretion of interest expense. Other amounts that may become due and payable under the Loan Agreement, including amounts shared between the parties with respect to cash flows received in excess of pre-defined thresholds, are recognized as additional interest expense when they become probable and estimable. The amount of principal to be repaid in each of the five succeeding years is not fixed and determinable. |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' (Deficit) Equity | |
Stockholders' (Deficit) Equity | 6. Stockholders’ (Deficit) Equity Equity Offerings Under its Amended and Restated Certificate of Incorporation (as amended, the “Certificate of Incorporation”), the Company was authorized to issue up to 200,000,000 shares of common stock as of June 30, 2024. The Company also was authorized to issue up to 5,000,000 shares of preferred stock as of June 30, 2024. The Company is required, at all times, to reserve and keep available out of its authorized but unissued shares of common stock sufficient shares to effect the conversion of the shares of the preferred stock and all outstanding stock options and warrants. December 2023 Equity Offering and Warrant issuance On December 28, 2023, the Company and a single investor entered into a securities purchase agreement whereby the Company issued 2,779,906 pre-funded warrants (the “Pre-Funded Warrants”) with an initial exercise price of $0.001 per share for $0.70 per Pre-Funded Warrant, which are exercisable immediately and do not expire. In addition, the investor received 2,779,906 common stock warrants with an initial exercise price of $0.70 per share, which are exercisable through April 19, 2029. Concurrent with the execution of the securities purchase agreement above, the Company and the investor entered into an inducement agreement whereby the Company agreed to reduce the exercise price of 2,934,380 warrants (the “Existing Warrants”) held by the investor from prior equity offerings. The weighted average exercise price of the Existing Warrants was $3.35 per share and was reduced to $0.70 per share in exchange for the investor agreeing to immediately exercise the ExistingWarrants. Of the Existing Warrants exercised, 1,234,380 were held in abeyance for the benefit of the holder due to certain beneficial ownership limitations and these shares were subsequently issued to the investor on June 26, 2024. In addition to reducing the exercise price, the Company issued 5,868,760 common stock warrants (the “Inducement Warrants”) to the investor with an initial exercise price of $0.70 per share, which are exercisable through April 19, 2029. The fair value of the Inducement Warrants and the change in fair value of the Existing Warrants resulting from the reduction in the exercise price totaling $4.2 million was accounted for as equity issuance costs in the consolidated statement of operations. The Company received $3.5 million in total, after deducting underwriter fees and other third-party costs, as a result of the sale of pre-funded warrants and exercise of the warrants as part of the inducement. The warrants issued did not meet the requirements to be indexed to equity and equity classified and, as such, are classified as liabilities at fair value with changes in fair value recorded within other income (expense), net on the consolidated statements of operations and comprehensive loss. Equity Incentive Plan 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, 2024 2023 Research and development $ 295 $ 295 Selling, general and administrative 974 1,213 Total stock-based compensation $ 1,269 $ 1,508 Stock Options A summary of stock option activity and related information through June 30, 2024 follows: Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, December 31, 2023 403,484 $ 35.68 6.81 Granted 82,200 0.40 Exercised — — Forfeited/Cancelled (30,314) ` 36.20 Balance, June 30, 2024 455,370 $ 29.28 6.83 Vested or expected to vest at June 30, 2024 455,370 $ 29.28 6.83 Exercisable at June 30, 2024 330,769 $ 38.04 5.87 The aggregate intrinsic value of options exercisable as of June 30, 2024, was zero, based on the difference between the Company’s closing stock price of $0.218 and the exercise price of each stock option. The Company uses the Black Scholes option pricing model to estimate the fair value of stock options at the grant date. The Black Scholes model requires the Company to make certain estimates and assumptions, including estimating the fair value of the Company’s common stock, assumptions related to the expected price volatility of the Company’s 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 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, 2024 and 2023 was estimated at $ and $ per share, respectively, on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions: June 30, 2024 2023 Expected term of options (in years) 5.5 5.5 Risk-free interest rate 4.2 % 3.9 % Expected volatility 118.5 % 105.5 % 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, 2024: Weighted Average Number of Grant Date Awards Fair Value Non-vested at December 31, 2023 1,602,588 $ 2.05 Granted — — Vested (28,150) 3.45 Forfeited/Cancelled (158,146) 1.88 Non-vested at June 30, 2024 1,416,292 $ 2.04 For the six months ended June 30, 2024, the Company recorded $0.8 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, 2024, there was $1.8 million of total unrecognized compensation expense related to unvested RSUs that will be recognized over the weighted average remaining period of 2.03 years. Shares Available for Future Grant At June 30, 2024, the Company has the following shares available to be granted under its equity incentive plans: Inducement 2023 Plan Plan Available at December 31, 2023 253,463 12,000 Authorized — — Granted (82,200) — Shares withheld for taxes not issued 8,207 — Forfeited/Cancelled 188,460 — Available at June 30, 2024 367,930 12,000 Shares Reserved for Future Issuance At June 30, 2024, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 262,420 Stock options outstanding under 2023 Plan 184,950 Restricted stock units outstanding under 2013 Plan 1,416,292 Stock options outstanding under Inducement Plan 8,000 Warrants outstanding 8,852,780 Total shares of common stock reserved for future issuance 10,724,442 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
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. On August 3, 2023, Vanguard exercised its second option to extend its sublease term. The Company and Vanguard agreed to further extend the sublease through May 2028. With the current extension to May 2028, Vanguard’s sublease is coterminous with the Company’s master lease term. 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) Supplemental balance sheet information related to leases was as follows (in thousands): June 30, 2024 December 31, 2023 Operating leases: Operating lease right-of-use assets $ 3,354 $ 3,665 Other current lease liabilities 1,062 1,002 Operating lease liabilities 3,873 4,417 Total operating lease liabilities $ 4,935 $ 5,419 Finance leases: Property and equipment, at cost $ 29 $ 29 Accumulated depreciation (18) (13) Property and equipment, net 11 16 Other current lease liabilities 10 10 Other long-term liabilities 2 7 Total finance lease liabilities $ 12 $ 17 The components of lease expense were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Operating lease costs: Operating lease expense $ 351 $ 349 $ 739 $ 746 Other income (370) (347) (720) (697) Total operating lease costs $ (19) $ 2 $ 19 $ 49 Finance lease costs: Amortization of right-of-use assets 3 2 5 5 Interest on lease liabilities — — — — Total finance lease costs $ 3 $ 2 $ 5 $ 5 Supplemental cash flow information related to leases was as follows (in thousands): Six Months Ended June 30, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (166) $ (209) Financing cash flows from finance leases (5) (5) Our lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2024 (July 1 - December 31) 730 5 2025 1,474 8 2026 1,498 — 2027 1,523 — 2028 640 — Total minimum lease payments $ 5,865 $ 13 Less: imputed interest (930) (1) Lease liability $ 4,935 $ 12 Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2024 (April 1 - December 31) 580 2025 1,178 2026 1,198 2027 1,166 2028 254 Total minimum lease payments $ 4,376 Weighted average lease term and discount rates are as follows: Six Months Ended June 30, 2024 2023 Weighted average remaining lease term (years) Operating leases 4 5 Finance leases 1 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, 2024 | |
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, 2024 (in thousands): Sales Discounts Chargebacks Fee for Service Balance, January 1, 2024 $ 2 19 9 Provision related to sales recorded in the period 1 6 6 Credits / payments during the period — (4) — Adjustments related to prior period sales — — — Balance, June 30, 2024 $ 3 $ 21 $ 15 |
License and Royalty Revenue
License and Royalty Revenue | 6 Months Ended |
Jun. 30, 2024 | |
License and Royalty Revenue. | |
License and Royalty Revenue | 9. License and Royalty 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. In the third quarter of 2023, Nhwa launched OLINVYK, recognized net product sales in China and reported royalties on those sales to the Company. 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, 2024 and 2023, 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, 2024 2023 2024 2023 Pharmbio Korea Inc. $ — $ — $ — $ — Jiangsu Nhwa Pharmaceutical Co. Ltd. — 3,000 — 3,000 Total license revenues $ — $ 3,000 $ — $ 3,000 Jiangsu Nhwa Pharmaceutical Co. Ltd. 311 — 311 — Total royalty revenues $ 311 $ — $ 311 $ — Total license and royalty revenues $ 311 $ 3,000 $ 311 $ 3,000 Royalty revenue recorded for the three and six months ended June 30, 2024, relates to royalties earned on OLINVYK sales by Nhwa in China and payable to R-Bridge. 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. |
Net Loss Per Common Share
Net Loss Per Common Share | 6 Months Ended |
Jun. 30, 2024 | |
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, 2024 2023 2024 2023 Basic and diluted net loss per common share calculation: Net loss $ (4,891) $ (8,012) $ (12,569) $ (15,831) Weighted average common shares outstanding 21,318,073 11,580,128 21,310,772 10,592,586 Net loss per share of common stock - basic and diluted $ (0.23) $ (0.69) $ (0.59) $ (1.49) The following outstanding securities at June 30, 2024 and 2023 have been excluded from the computation of diluted weighted shares outstanding, as they would have been anti-dilutive: June 30, 2024 2023 Options outstanding 455,370 421,564 RSUs outstanding 1,416,292 781,235 Warrants outstanding 8,852,780 3,145,394 Total 10,724,442 4,348,193 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (4,891) | $ (7,678) | $ (8,012) | $ (7,819) | $ (12,569) | $ (15,831) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
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, 2024, its results of operations and its comprehensive loss for the six months ended June 30, 2024 and 2023, its consolidated statements of stockholders’ equity for the period from January 1, 2024 to June 30, 2024 and for the period January 1, 2023 to June 30, 2023, and its consolidated statements of cash flows for the six months ended June 30, 2024 and 2023. 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, 2023. 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, 2024 and 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, 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 (which was later converted to a limited liability company, Trevena Royalty, LLC), 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, 2024. 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. Management used significant estimates in the following areas, among others: stock-based compensation expense, the determination of the fair value of stock-based awards, the fair value of common stock warrants, the accounting for research and development costs, accrued expenses, the recoverability of the Company’s net deferred tax assets and related valuation allowance, and the amortization of debt expenses. The financial data and other information disclosed in these notes are not necessarily indicative of the results to be expected for any future year or period. The Company bases its estimates on historical experience and also on assumptions that it believes are reasonable, however, actual results could significantly differ from those results. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, restricted cash, accounts payable, and accrued expenses approximate their fair values, given their short-term nature. Additionally, the Company believes the carrying value of the loan payable approximates its fair value as the interest rate is reflective of the rate the Company could obtain on debt with similar terms and conditions. Certain of the Company’s common stock warrants are carried at fair value, as disclosed in Note 3. The Company has evaluated the estimated fair value of financial instruments using available market information and management’s estimates. The use of different market assumptions and/or estimation methodologies could have a significant effect on the estimated fair value amounts. See Note 3 for additional information. |
Product Revenue | Product Revenue Product revenue is recognized at the point in time when our performance obligations with our customers have been satisfied. At contract inception, we determine if the contract is within the scope of ASC Topic 606 and then evaluate the contract using the following five steps: (i) identify the contract with the customer; (ii) identify the performance obligations; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue at the point in time when the Company satisfies a performance obligation. OLINVYK is sold to wholesalers in the US (collectively, “customers”). These customers subsequently resell OLINVYK generally to hospitals, ambulatory surgical centers and other purchasers of OLINVYK. We recognize revenue from OLINVYK sales at the point customers obtain control of the product, which generally occurs upon delivery. Revenue is recorded at the transaction price, which is the amount of consideration we expect to receive in exchange for transferring products to a customer. We determine the transaction price based on fixed consideration in our contractual agreements, which includes estimates of variable consideration which are more fully described below. The transaction price is allocated entirely to the performance obligation to provide pharmaceutical products. In determining the transaction price, a significant financing component does not exist since the timing from when we deliver product to when the customers pay for the product is less than one year and the customers do not pay for product in advance of the transfer of the product. |
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 and has determined that the constraint does not apply, since it is probable that a significant reversal in the amount of cumulative revenue will not occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. The Company’s estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result in a change in the amount of total consideration it expects to receive. |
Distributor Chargebacks | Distributor Chargebacks When a product that is subject to a contractual price agreement is sold to a third party, the difference between the price paid to the Company by the wholesaler and the price under the specific contract is charged back to the Company by the wholesaler. Utilizing this information, the Company estimates a chargeback percentage for each product and records an allowance for chargebacks as a reduction to revenue when the Company records sales of the products. We reduce the chargeback allowance when a chargeback request from a wholesaler is processed. Reserves for distributor chargebacks are included in accounts receivable, net on the consolidated balance sheet. |
Prompt Payment (Cash) Discounts | Prompt Payment (Cash) Discounts The Company provides customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The Company’s prompt payment discount reserves are based on actual net sales and contractual discount rates. Reserves for prompt payment discounts are included in accounts receivable, net on the consolidated balance sheet. |
Distribution Service Fees | Distribution Service Fees The Company pays distribution service fees to its customers based on a fixed percentage of the product price. These fees are not in exchange for a distinct good or service and therefore are recognized as a reduction of the transaction price. The Company reserves for these fees based on actual net sales, contractual fee rates negotiated with the customer and the mix of the products in the distribution channel that remain subject to fees. Reserves for distribution service fees are included in accounts receivable, net on the consolidated balance sheet. |
Product Returns | 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. The Company does not currently rely on industry data in its analysis of returns reserve. As the Company sold OLINVYK and established historical sales over a longer period of time (i.e., two to three years), the Company placed more reliance on historical purchasing, demand and return patterns of its customers when evaluating its 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, 2024 | |
Stockholders' (Deficit) Equity | |
Schedule of cash, cash equivalents, marketable securities and restricted cash | June 30, Quoted Prices in Active Markets Significant Other Observable Inputs Unobservable Inputs Description: 2024 (Level 1) (Level 2) (Level 3) Assets: Cash $ 951 $ 951 $ — $ — Money Market Funds 15,416 15,416 — — Restricted Cash 540 540 — — Total assets measured and recorded at fair value $ 16,907 $ 16,907 $ — $ — Liabilities: Warrant Liability 1,292 — — 1,292 Total liabilities measured and recorded at fair value $ 1,292 $ — $ — $ 1,292 December 31, Quoted Prices in Active Markets Significant Other Observable Inputs Unobservable Inputs Description: 2023 (Level 1) (Level 2) (Level 3) Assets: Cash $ 3,159 $ 3,159 $ — $ — Money Market Funds 29,816 29,816 — — Restricted Cash 540 540 — — Total assets measured and recorded at fair value $ 33,515 $ 33,515 $ — $ — Liabilities: Warrant Liability 5,475 — — 5,475 Total liabilities measured and recorded at fair value $ 5,475 $ — $ — $ 5,475 (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. |
Schedule of assumptions used for valuation of warrants | June 30, 2024 December 31, 2023 Expected term of warrants (in years) 4.8 5.3 Risk-free interest rate 4.3 % 3.8 % Expected volatility 115.84 % 128.26 % Dividend yield — % — % |
Schedule of roll forward of common stock warrant liability | The following is a roll forward of the December 2023 Offering common stock warrant liability (in thousands): Warrant Liability Balance, December 31, 2023 $ 5,475 Change in fair value (4,183) Balance, June 30, 2024 $ 1,292 |
Schedule of common stock warrants outstanding | Classification Warrants Exercise Price Expiration Date December 2023 Offering Warrants Liability 8,648,666 0.70 4/19/2029 R-Bridge warrants Equity 200,000 20.50 4/14/2025 Other warrants Equity 4,114 90.38 - 265.48 9/19/2024 - 3/31/2027 8,852,780 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventories | |
Schedule of Inventories | Inventory consists of the following (in thousands): June 30, 2024 December 31, 2023 Finished goods $ 896 $ 896 Inventory Valuation Adjustment (896) (896) Total Inventories $ - $ - |
Loans Payable (Tables)
Loans Payable (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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, 2024 Principal and accreted interest $ 32,851 Unamortized debt discount (1,324) Loans payable, net $ 31,527 |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' (Deficit) Equity | |
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, 2024 2023 Research and development $ 295 $ 295 Selling, general and administrative 974 1,213 Total stock-based compensation $ 1,269 $ 1,508 |
Summary of stock option activity | Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, December 31, 2023 403,484 $ 35.68 6.81 Granted 82,200 0.40 Exercised — — Forfeited/Cancelled (30,314) ` 36.20 Balance, June 30, 2024 455,370 $ 29.28 6.83 Vested or expected to vest at June 30, 2024 455,370 $ 29.28 6.83 Exercisable at June 30, 2024 330,769 $ 38.04 5.87 |
Schedule of weighted-average assumptions | June 30, 2024 2023 Expected term of options (in years) 5.5 5.5 Risk-free interest rate 4.2 % 3.9 % Expected volatility 118.5 % 105.5 % 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, 2023 1,602,588 $ 2.05 Granted — — Vested (28,150) 3.45 Forfeited/Cancelled (158,146) 1.88 Non-vested at June 30, 2024 1,416,292 $ 2.04 |
Schedule of shares available to be granted under equity incentive plans | Inducement 2023 Plan Plan Available at December 31, 2023 253,463 12,000 Authorized — — Granted (82,200) — Shares withheld for taxes not issued 8,207 — Forfeited/Cancelled 188,460 — Available at June 30, 2024 367,930 12,000 |
Schedule of shares of common stock reserved for future issuance | At June 30, 2024, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 262,420 Stock options outstanding under 2023 Plan 184,950 Restricted stock units outstanding under 2013 Plan 1,416,292 Stock options outstanding under Inducement Plan 8,000 Warrants outstanding 8,852,780 Total shares of common stock reserved for future issuance 10,724,442 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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, 2024 December 31, 2023 Operating leases: Operating lease right-of-use assets $ 3,354 $ 3,665 Other current lease liabilities 1,062 1,002 Operating lease liabilities 3,873 4,417 Total operating lease liabilities $ 4,935 $ 5,419 Finance leases: Property and equipment, at cost $ 29 $ 29 Accumulated depreciation (18) (13) Property and equipment, net 11 16 Other current lease liabilities 10 10 Other long-term liabilities 2 7 Total finance lease liabilities $ 12 $ 17 |
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, 2024 2023 2024 2023 Operating lease costs: Operating lease expense $ 351 $ 349 $ 739 $ 746 Other income (370) (347) (720) (697) Total operating lease costs $ (19) $ 2 $ 19 $ 49 Finance lease costs: Amortization of right-of-use assets 3 2 5 5 Interest on lease liabilities — — — — Total finance lease costs $ 3 $ 2 $ 5 $ 5 |
Schedule of supplemental cash flow information | Supplemental cash flow information related to leases was as follows (in thousands): Six Months Ended June 30, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (166) $ (209) Financing cash flows from finance leases (5) (5) |
Schedule of maturities of operating lease liabilities | Our lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2024 (July 1 - December 31) 730 5 2025 1,474 8 2026 1,498 — 2027 1,523 — 2028 640 — Total minimum lease payments $ 5,865 $ 13 Less: imputed interest (930) (1) Lease liability $ 4,935 $ 12 |
Schedule of maturities of financing lease liabilities | Our lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2024 (July 1 - December 31) 730 5 2025 1,474 8 2026 1,498 — 2027 1,523 — 2028 640 — Total minimum lease payments $ 5,865 $ 13 Less: imputed interest (930) (1) Lease liability $ 4,935 $ 12 |
Schedule of expected sublease inflows | Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2024 (April 1 - December 31) 580 2025 1,178 2026 1,198 2027 1,166 2028 254 Total minimum lease payments $ 4,376 |
Schedule of weighted average lease term and discount rates | Six Months Ended June 30, 2024 2023 Weighted average remaining lease term (years) Operating leases 4 5 Finance leases 1 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, 2024 | |
Revenue. | |
Schedule of major categories of sales-related deductions included in trade receivable allowances | 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, 2024 (in thousands): Sales Discounts Chargebacks Fee for Service Balance, January 1, 2024 $ 2 19 9 Provision related to sales recorded in the period 1 6 6 Credits / payments during the period — (4) — Adjustments related to prior period sales — — — Balance, June 30, 2024 $ 3 $ 21 $ 15 |
License and Royalty Revenue (Ta
License and Royalty Revenue (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Revenue. | |
Schedule of license revenue | Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Pharmbio Korea Inc. $ — $ — $ — $ — Jiangsu Nhwa Pharmaceutical Co. Ltd. — 3,000 — 3,000 Total license revenues $ — $ 3,000 $ — $ 3,000 Jiangsu Nhwa Pharmaceutical Co. Ltd. 311 — 311 — Total royalty revenues $ 311 $ — $ 311 $ — Total license and royalty revenues $ 311 $ 3,000 $ 311 $ 3,000 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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, 2024 2023 2024 2023 Basic and diluted net loss per common share calculation: Net loss $ (4,891) $ (8,012) $ (12,569) $ (15,831) Weighted average common shares outstanding 21,318,073 11,580,128 21,310,772 10,592,586 Net loss per share of common stock - basic and diluted $ (0.23) $ (0.69) $ (0.59) $ (1.49) |
Schedule of outstanding securities excluded from the computation of diluted weighted shares outstanding as they would have been anti-dilutive | June 30, 2024 2023 Options outstanding 455,370 421,564 RSUs outstanding 1,416,292 781,235 Warrants outstanding 8,852,780 3,145,394 Total 10,724,442 4,348,193 |
Organization and Description _2
Organization and Description of the Business (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2024 USD ($) | Mar. 31, 2024 USD ($) | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Jun. 30, 2024 USD ($) segment | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Organization and Description of the Business | |||||||
Number of operating segments | segment | 1 | ||||||
Accumulated deficit | $ 600,630 | $ 600,630 | $ 588,061 | ||||
Net loss | $ 4,891 | $ 7,678 | $ 8,012 | $ 7,819 | $ 12,569 | $ 15,831 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 6 Months Ended |
Jun. 30, 2024 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, 2024 | Dec. 31, 2023 | |
Liabilities | ||
Transfers between Level 2 and Level 3 | $ 0 | |
Fair Value | ||
Assets | ||
Cash | 951 | $ 3,159 |
Money market funds | 15,416 | 29,816 |
Restricted cash | 540 | 540 |
Total | 16,907 | 33,515 |
Liabilities | ||
Liabilities | 1,292 | 5,475 |
Warrants | Fair Value | ||
Liabilities | ||
Liabilities | 1,292 | 5,475 |
Level 1 | ||
Assets | ||
Cash | 951 | 3,159 |
Money market funds | 15,416 | 29,816 |
Restricted cash | 540 | 540 |
Total | 16,907 | 33,515 |
Level 3 | Fair Value | ||
Liabilities | ||
Liabilities | 1,292 | 5,475 |
Level 3 | Warrants | Fair Value | ||
Liabilities | ||
Liabilities | $ 1,292 | $ 5,475 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Additional Information (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2023 | |
Warrant liability rollforward | |||||
Beginning balance | $ 5,475 | ||||
Change in fair value of warrant liability | $ (1,822) | $ 763 | (4,183) | $ (1,703) | |
Ending balance | 1,292 | 1,292 | |||
December 2023 Equity Offering and Warrant Issuance | |||||
Warrant liability rollforward | |||||
Beginning balance | 5,475 | ||||
Change in fair value of warrant liability | (4,183) | ||||
Ending balance | $ 1,292 | $ 1,292 | |||
Estimated remaining term | |||||
Warrants | |||||
Warrant liability measurement input | 4.8 | 4.8 | 5.3 | ||
Risk-free interest rate | |||||
Warrants | |||||
Warrant liability measurement input | 4.3 | 4.3 | 3.8 | ||
Volatility | |||||
Warrants | |||||
Warrant liability measurement input | 115.84 | 115.84 | 128.26 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments- Registered Direct Stock Offering and Concurrent Warrant Issuance (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Stockholders' Equity | ||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 8,852,780 | 8,852,780 | ||
Change in fair value of warrant liability | $ 1,822 | $ (763) | $ 4,183 | $ 1,703 |
December 2023 Equity Offering and Warrant Issuance | ||||
Stockholders' Equity | ||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 8,648,666 | 8,648,666 | ||
Exercise price (in dollars per share) | $ 0.70 | $ 0.70 | ||
Change in fair value of warrant liability | $ 4,183 | |||
R-Bridge Financing | ||||
Stockholders' Equity | ||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 200,000 | 200,000 | ||
Exercise price (in dollars per share) | $ 20.50 | $ 20.50 | ||
Other Warrants | ||||
Stockholders' Equity | ||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 4,114 | 4,114 | ||
Other Warrants | Minimum | ||||
Stockholders' Equity | ||||
Exercise price (in dollars per share) | $ 90.38 | $ 90.38 | ||
Other Warrants | Maximum | ||||
Stockholders' Equity | ||||
Exercise price (in dollars per share) | $ 265.48 | $ 265.48 |
Inventories - Schedule Of Inven
Inventories - Schedule Of Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Inventories | ||
Finished goods | $ 896 | $ 896 |
Inventory Valuation Adjustment | $ (896) | $ (896) |
Inventories - narrative (Detail
Inventories - narrative (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Inventories | |
Inventory valuation adjustment | $ 0.9 |
Loan Payable (Details)
Loan Payable (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jul. 31, 2024 USD ($) $ / shares | Jun. 30, 2024 USD ($) shares | Apr. 30, 2022 USD ($) tranche $ / shares shares | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Long Term Debt | ||||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | shares | 8,852,780 | 8,852,780 | 8,852,780 | |||||
Interest expense | $ 521 | $ 1,122 | $ 1,034 | $ 1,568 | ||||
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 | |||||||
Face amount | $ 32,851 | 32,851 | 32,851 | |||||
Unamoritized debt discount | (1,324) | (1,324) | (1,324) | |||||
Loans payable, net | $ 31,527 | $ 31,527 | $ 31,527 | |||||
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 | |||||||
Prepaid interest | $ 0 | |||||||
Effective interest rate (as a percent) | 5.80% | 5.80% | 5.80% | |||||
Exercise price (in dollars per share) | $ / shares | $ 0.28 | |||||||
Warrants term | 5 years | |||||||
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 | |||||||
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 | $ 700 | |||||||
Amortization of debt discount | $ 100 | |||||||
R-Bridge Financing | Royalty Based Loan Agreement - Second Tranche | ||||||||
Long Term Debt | ||||||||
Commercialization milestone payments | $ 10,000 | $ 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 | |||||||
R-Bridge Financing | Amendment to Royalty Based Loan Agreement | ||||||||
Long Term Debt | ||||||||
Commercialization milestone payments | $ 12,000 | |||||||
Milestone payment received under agreement | 2,000 | |||||||
Milestone payment to be received upon achievement of certain US partnering and US commercial milestones | 8,000 | |||||||
Minimum or fixed payments under collaborative arrangement | 0 | |||||||
Amount of royalty payments forgiven | $ 10,000 | |||||||
Term of loan | 5 years |
Stockholders (Deficit) Equity -
Stockholders (Deficit) Equity - Equity Offering and Warrant issuance (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Dec. 28, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 27, 2023 | |
Stockholders' Equity | |||||||
Common stock authorized (in shares) | 200,000,000 | 200,000,000 | 200,000,000 | ||||
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 | 5,000,000 | ||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 8,852,780 | 8,852,780 | |||||
Change in fair value of warrant liability | $ 1,822 | $ (763) | $ 4,183 | $ 1,703 | |||
December 2023 Equity Offering and Warrant Issuance | |||||||
Stockholders' Equity | |||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 8,648,666 | 8,648,666 | |||||
Exercise price (in dollars per share) | $ 0.70 | $ 0.70 | |||||
Change in fair value of warrant liability | $ 4,183 | ||||||
December 2023 Equity Offering and Warrant Issuance | Common Stock Warrants | |||||||
Stockholders' Equity | |||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 2,779,906 | ||||||
Exercise price (in dollars per share) | $ 0.70 | ||||||
December 2023 Equity Offering and Warrant Issuance | Pre-funded Common Stock Warrants | |||||||
Stockholders' Equity | |||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | 2,779,906 | ||||||
Warrant price (in dollars per share) | $ 0.70 | ||||||
Exercise price (in dollars per share) | $ 0.001 | ||||||
December 2023 Inducement Agreement | |||||||
Stockholders' Equity | |||||||
Number of warrants held by investor (in shares) | 2,934,380 | ||||||
Number of warrants exercised held in abeyance (in shares) | 1,234,380 | ||||||
Exercise price (in dollars per share) | $ 0.70 | $ 3.35 | |||||
Granted (in shares) | 5,868,760 | ||||||
Change in fair value of warrant liability | $ 4,200 | ||||||
Proceeds from sale of pre-funded warrants and exercise of warrants | $ 3,500 |
Stockholders' (Deficit) Equit_2
Stockholders' (Deficit) Equity - Equity Incentive Plans (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Equity Incentive Plans | ||
Stock-based compensation | $ 1,269 | $ 1,508 |
Research and Development Expense | ||
Equity Incentive Plans | ||
Stock-based compensation | 295 | 295 |
General and Administrative Expense | ||
Equity Incentive Plans | ||
Stock-based compensation | $ 974 | $ 1,213 |
Stockholders' (Deficit) Equit_3
Stockholders' (Deficit) Equity - Stock option activity (Details) - Employee Stock Option - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Number of Shares | ||
Balance at the beginning of the period (in shares) | 403,484 | |
Granted (in shares) | 82,200 | |
Forfeited/Cancelled (in shares) | (30,314) | |
Balance at the end of the period (in shares) | 455,370 | 403,484 |
Vested or expected to vest at the end of the period (in shares) | 455,370 | |
Exercisable at the end of the period (in shares) | 330,769 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ 35.68 | |
Granted (in dollars per share) | 0.40 | |
Forfeited/Cancelled (in dollars per share) | 36.20 | |
Balance at the end of the period (in dollars per share) | 29.28 | $ 35.68 |
Vested or expected to vest at the end of the period (in dollars per share) | 29.28 | |
Exercisable at the end of the period (in dollars per share) | $ 38.04 | |
Weighted Average Remaining Contractual Term | ||
Options Outstanding at the end of the period | 6 years 9 months 29 days | 6 years 9 months 21 days |
Vested or expected to vest at the end of the period | 6 years 9 months 29 days | |
Exercisable at the end of the period | 5 years 10 months 13 days |
Stockholders' (Deficit) Equit_4
Stockholders' (Deficit) Equity - Options other Info (Details) - Employee Stock Option - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Options outstanding | ||
Intrinsic value of options exercisable | $ 0 | |
Closing price of Company's stock (in dollars per share) | $ 0.218 | |
Per-share weighted-average grant date fair value of options granted (in dollars per share) | $ 0.33 | $ 0.81 |
Weighted-average | ||
Weighted-average assumptions: | ||
Expected term of options (in years) | 5 years 6 months | 5 years 6 months |
Risk-free interest rate (as a percent) | 4.20% | 3.90% |
Expected volatility (as a percent) | 118.50% | 105.50% |
Stockholders' (Deficit) Equit_5
Stockholders' (Deficit) Equity - Non-vested RSUs (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Weighted Average Grant Date Fair Value | ||
Stock-based compensation | $ 1,269 | $ 1,508 |
RSUs | ||
Number of Shares | ||
Non-vested at beginning of period (in shares) | 1,602,588 | |
Vested (in shares) | (28,150) | |
Forfeited/Cancelled (in shares) | (158,146) | |
Non-vested at end of period (in shares) | 1,416,292 | |
Weighted Average Grant Date Fair Value | ||
Non-vested at beginning of period (in dollars per share) | $ 2.05 | |
Vested (in dollars per share) | 3.45 | |
Forfeited (in dollars per share) | 1.88 | |
Non-vested at end of period (in dollars per share) | $ 2.04 | |
Stock-based compensation | $ 800 | |
Unrecognized compensation expense | $ 1,800 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 2 years 10 days |
Stockholders' (Deficit) Equit_6
Stockholders' (Deficit) Equity - Shares Reserved for Future Grant and Issuance (Details) check - shares | 6 Months Ended | |
Jun. 30, 2024 | Dec. 31, 2023 | |
Shares Reserved for Future Issuance | ||
Warrants outstanding (in shares) | 8,852,780 | |
Total shares of common stock reserved for future issuance (in shares) | 10,724,442 | |
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 | |
2023 Plan | ||
Shares Available for Future Grant | ||
Balance at the beginning of the period (in shares) | 253,463 | |
Granted (in shares) | (82,200) | |
Shares withheld for taxes not issued (in shares) | 8,207 | |
Forfeited/Cancelled (in shares) | 188,460 | |
Balance at the end of the period (in shares) | 367,930 | |
Employee Stock Option | ||
Shares Reserved for Future Issuance | ||
Stock options outstanding (in shares) | 455,370 | 403,484 |
Employee Stock Option | 2013 plan | ||
Shares Reserved for Future Issuance | ||
Stock options outstanding (in shares) | 262,420 | |
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) | 184,950 | |
RSUs | 2013 plan | ||
Shares Reserved for Future Issuance | ||
Stock options outstanding (in shares) | 1,416,292 |
Commitments and Contingencies -
Commitments and Contingencies - Leases (Details) - Chesterbrook, Pennsylvania | Oct. 02, 2020 | Oct. 11, 2018 ft² $ / ft² | Jun. 30, 2024 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 through 13 | 0.50 | ||
Amount per square foot less for rent during months 14 through 109 | 1 | ||
Amount per square foot less for rent during months 110 through 116 | 16.50 |
Commitments and Contingencies_2
Commitments and Contingencies - Balance sheet information related to leases (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Leases | ||
Operating lease right-of-use assets | $ 3,354 | $ 3,665 |
Operating lease liabilities - Current | $ 1,062 | $ 1,002 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Lease Liability Current | Lease Liability Current |
Operating lease liabilities - Noncurrent | $ 3,873 | $ 4,417 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease Liability Noncurrent | Lease Liability Noncurrent |
Lease Liability | $ 4,935 | $ 5,419 |
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 | $ 1,018 | $ 1,195 |
Finance lease liabilities - Current | $ 10 | $ 10 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Lease Liability Current | Lease Liability Current |
Finance lease liabilities - Noncurrent | $ 2 | $ 7 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease Liability Noncurrent | Lease Liability Noncurrent |
Lease Liability | $ 12 | $ 17 |
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 | (18) | (13) |
Property and equipment, net | $ 11 | $ 16 |
Commitments and Contingencies_3
Commitments and Contingencies - Components of lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating lease costs: | ||||
Operating lease expense | $ 351 | $ 349 | $ 739 | $ 746 |
Other income | (370) | (347) | (720) | (697) |
Total operating lease costs | (19) | 2 | 19 | 49 |
Finance lease costs: | ||||
Amortization of right-of-use assets | 3 | 2 | 5 | 5 |
Total finance lease costs | $ 3 | $ 2 | $ 5 | $ 5 |
Commitments and Contingencies_4
Commitments and Contingencies - Cash flow information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Commitments and Contingencies. | ||
Operating cash flows from operating leases | $ (166) | $ (209) |
Financing cash flows from finance leases | $ (5) | $ (5) |
Commitments and Contingencies_5
Commitments and Contingencies - Lease liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Operating Leases | ||
2024 (July 1 - December 31) | $ 730 | |
2025 | 1,474 | |
2026 | 1,498 | |
2027 | 1,523 | |
2028 | 640 | |
Total minimum lease payments | 5,865 | |
Interest Expense | (930) | |
Lease Liability | 4,935 | $ 5,419 |
Financing Leases | ||
2024 (July 1 - December 31) | 5 | |
2025 | 8 | |
Total minimum lease payments | 13 | |
Interest Expense | (1) | |
Lease Liability | 12 | $ 17 |
Sublease | ||
2024 (July 1 - December 31) | 580 | |
2025 | 1,178 | |
2026 | 1,198 | |
2027 | 1,166 | |
2028 | 254 | |
Total minimum lease payments | $ 4,376 |
Commitments and Contingencies_6
Commitments and Contingencies - Lease term and discount rates (Details) | Jun. 30, 2024 | Jun. 30, 2023 |
Commitments and Contingencies. | ||
Weighted average remaining lease term - Operating leases | 4 years | 5 years |
Weighted average remaining lease term - Finance leases | 1 year | 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, 2024 USD ($) | |
Sales Discounts | |
Beginning Balance | $ 2,000 |
Provision related to sales recorded in the period | 1,000 |
Ending Balance | 3,000 |
Chargebacks | |
Beginning Balance | 19,000 |
Provision related to sales recorded in the period | 6,000 |
Credit / payments made during the period | (4,000) |
Ending Balance | 21,000 |
Fee for Service | |
Beginning Balance | 9,000 |
Provision related to sales recorded in the period | 6,000 |
Ending Balance | 15,000 |
Outstanding accounts receivable | $ 39,000 |
License and Royalty Revenue (De
License and Royalty 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, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
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 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 and royalty revenues | ||||||||
Licensing Arrangements | ||||||||
Total revenue | $ 311 | $ 3,000 | $ 311 | $ 3,000 | ||||
License revenue | ||||||||
Licensing Arrangements | ||||||||
Total revenue | 3,000 | 3,000 | ||||||
License revenue | Licensing agreements for development and commercialization | ||||||||
Licensing Arrangements | ||||||||
Withholding taxes | $ 500 | |||||||
License revenue | Jiangsu Nhwa Pharmaceutical Co Ltd | ||||||||
Licensing Arrangements | ||||||||
Total revenue | $ 3,000 | $ 3,000 | ||||||
Royalty revenue | ||||||||
Licensing Arrangements | ||||||||
Total revenue | 311 | 311 | ||||||
Royalty revenue | Jiangsu Nhwa Pharmaceutical Co Ltd | ||||||||
Licensing Arrangements | ||||||||
Total revenue | $ 311 | $ 311 |
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, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 28, 2023 | |
Basic and diluted net loss per common share calculation: | |||||||
Net Income (Loss) | $ (4,891) | $ (7,678) | $ (8,012) | $ (7,819) | $ (12,569) | $ (15,831) | |
Weighted average common shares outstanding, basic (in shares) | 21,318,073 | 11,580,128 | 21,310,772 | 10,592,586 | |||
Weighted average common shares outstanding, diluted (in shares) | 21,318,073 | 11,580,128 | 21,310,772 | 10,592,586 | |||
Net loss per share of common stock, basic (in dollars per share) | $ (0.23) | $ (0.69) | $ (0.59) | $ (1.49) | |||
Net loss per share of common stock, diluted (in dollars per share) | (0.23) | $ (0.69) | $ (0.59) | $ (1.49) | |||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 10,724,442 | 4,348,193 | |||||
December 2023 Equity Offering and Warrant Issuance | |||||||
Basic and diluted net loss per common share calculation: | |||||||
Exercise price (in dollars per share) | $ 0.70 | $ 0.70 | |||||
December 2023 Equity Offering and Warrant Issuance | Pre-funded Common Stock Warrants | |||||||
Basic and diluted net loss per common share calculation: | |||||||
Exercise price (in dollars per share) | $ 0.001 | ||||||
Employee Stock Option | |||||||
Basic and diluted net loss per common share calculation: | |||||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 455,370 | 421,564 | |||||
RSUs | |||||||
Basic and diluted net loss per common share calculation: | |||||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 1,416,292 | 781,235 | |||||
Warrants | |||||||
Basic and diluted net loss per common share calculation: | |||||||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 8,852,780 | 3,145,394 |