Scilex Holding Co: Form 10-Q for the period ended Jun 30, 2026
Filed with the SEC on Aug 14, 2026 and accepted by EDGAR at Aug 14, 2026, 16:41 ET.
Management's discussion and analysis
As filed, 94,780 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
The following discussion and analysis of our financial condition and results of operations should be read together with the unaudited condensed consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and our consolidated financial statements and related notes appearing in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (the “SEC”) on April 10, 2026 (the “Annual Report on Form 10-K”). In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from these forward-looking statements as a result of certain factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this Quarterly Report on Form 10-Q, including those set forth in the sections of this Quarterly Report on Form 10-Q titled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.” As a result of these risks, you should not place undue reliance on these forward-looking statements. We assume no obligation to revise or update any forward-looking statements for any reason, except as required by law.
Overview
We are an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. We believe that our innovative non-opioid product portfolio has the potential to provide effective pain management therapies that can have a transformative impact on patients’ lives. We target indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. We launched our first commercial product in October 2018, in-licensed two commercial products in 2022 and 2023, and are developing our late-stage pipeline. Our commercial product, ZTlido (lidocaine topical system) 1.8% (“ZTlido”), is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (“FDA”) for the relief of neuropathic pain associated with post-herpetic neuralgia (“PHN”), which is a form of post-shingles nerve pain. ZTlido possesses novel delivery and adhesion technology designed to address many of the limitations of current prescription lidocaine patches by providing significantly improved adhesion and continuous pain relief throughout the 12-hour administration period. We market ZTlido through a third-party dedicated sales force of about 34 people as of June 30, 2026, targeting 10,000 primary care physicians, pain specialists, neurologists and palliative care physicians who we believe treat the majority of PHN patients. We also in-licensed the exclusive right to commercialize GLOPERBA (colchicine USP) oral solution (“GLOPERBA”), an FDA-approved prophylactic treatment for painful gout flares in adults, in the United States of America (“U.S.” or the “United States”). We launched GLOPERBA in June 2024 and believe we are well-positioned to market and distribute the product. In January 2025, we in-licensed the rights to commercialize GLOPERBA outside of the U.S. In February 2023, we acquired the rights to patents, trademarks, regulatory approvals and other rights related to ELYXYB (celecoxib oral solution) (“ELYXYB”) and its commercialization in the U.S. and Canada. In April 2023, we launched ELYXYB in the U.S. for the treatment of acute migraine, with or without aura, in adults. In January 2025, we received approval from Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for ELYXYB for the acute treatment of migraine with or without aura in Canada.
Our development pipeline consists of three product candidates, (i) SP-102 (“SEMDEXA”) (10 mg, dexamethasone sodium phosphate viscous gel), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain or sciatica, which is in the second Phase 3 study initiated in September 2025, (ii) SP-103 (lidocaine topical system) 5.4% (“SP-103”), a Phase 2, next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain associated with muscle spasms and for which we have completed a Phase 2 trial in acute low back pain (“LBP”), and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride formulation for the treatment of fibromyalgia, for which Phase 1 trials were completed.
SEMDEXA has been granted fast track designation by the FDA and, if approved, could become the first FDA-approved alternative to off-label epidural steroid injections, which are administered over 12 million times annually in the United States. We have completed a pivotal Phase 3 study with final results received in March 2022, reflecting achievement of primary and secondary endpoints, and initiated the second Phase 3 study in September 2025. SP-103 has also been granted fast track designation by the FDA for LBP. We received our SP-103 Phase 2 top-line results in August 2023 and the trial achieved its objectives characterizing the safety, tolerability and preliminary efficacy of SP-103 in acute LBP associated with muscle spasms. SP-103 was safe and well tolerated. The threefold increase in lidocaine load in topical system, compared with approved ZTlido (5.4% vs. 1.8%), did not result in signs of systemic toxicity or increased application-site reactions with daily applications over one month of treatment. We will continue to analyze the SP-103 Phase 2 trial data along with an investigator study of ZTlido in patients with neck pain completed in the second half of 2023, which also has shown promising top-line efficacy and safety results. SP-103, if approved, could become the first FDA-approved lidocaine topical product for the treatment of chronic neck pain associated with muscle spasms. SP-103 is a triple-strength lidocaine topical system designed to deliver a dose of lidocaine three times higher than any lidocaine topical product that we are aware of, either approved or in development. We are examining SP-103 as a treatment for chronic neck pain associated with muscle spasms, a condition with high unmet need which we expect could affect over 20 million patients in the United States as of 2023. On October 20, 2024, we announced the successful end-of Phase 2 meeting with the FDA, leading to an agreed path forward to a new drug application (including other marketing applications, an “NDA”) for our product candidate, SP-103.
We currently contract with third parties for the manufacture, assembly, testing, packaging, storage and distribution of our products. We obtain our commercial supply of certain of our products, the clinical supply of our product candidates and certain of the raw materials used in our product candidates from sole or single source suppliers and manufacturers. Prior to April 2022, we relied on a single third-party logistics distribution provider, Cardinal Health 105, for ZTlido distribution in the United States. Cardinal Health 105 purchased and shipped ZTlido to customer wholesale distribution centers. Cardinal Health 105 also performed order management services on our behalf. On April 2, 2022, we announced the expansion of our direct distribution network to national and regional wholesalers and pharmacies. Cardinal Health 105 will continue to provide traditional third-party logistics functions for us.
Since our inception, we have invested substantial efforts and financial resources into acquiring product and technology rights while building our intellectual property portfolio and infrastructure. In June 2022, we in-licensed the exclusive right to commercialize GLOPERBA oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. In February 2023, we acquired rights to FDA-approved ELYXYB in the U.S. and Canada for the acute treatment of migraine. We intend to continue to explore and evaluate additional opportunities such as these to grow our business. We have incurred significant operating losses as a result of such investment efforts, including the development of SEMDEXA, conducting Phase 3 trials for SEMDEXA, and the development of SP-103 and SP-104. Our ability to generate sufficient revenue to achieve profitability will depend on the successful commercialization of our products, ZTlido, GLOPERBA and ELYXYB, and the development of our product candidates.
We had a net loss of $115.0 million and $44.0 million for the three months ended June 30, 2026 and 2025, and a net loss of $160.6 million and $70.1 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $1,078.6 million. As of June 30, 2026, we had cash and cash equivalents of approximately $0.6 million. Our management has concluded that there is substantial doubt about our ability to continue as a going concern for one year after the date that the unaudited condensed consolidated financial statements are issued. See Note 2 titled “Liquidity and Going Concern” to our unaudited condensed consolidated financial statements and our independent registered public accounting firm’s report included elsewhere in this Quarterly Report on Form 10-Q for additional information.
We expect to continue to make investments in our marketing organization and expand digital marketing efforts to broaden awareness of ZTlido, GLOPERBA and ELYXYB and in research and development, clinical trials and regulatory affairs to develop our product candidates, SEMDEXA, SP-103 and SP-104. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, government contracts or other strategic transactions. We may be unable to raise additional funds or enter into such agreements or arrangements when needed on favorable terms, or at all. If adequate funds on acceptable terms are not available when needed, we may be required to reduce the scope of the commercialization of ZTlido, GLOPERBA and ELYXYB or delay, scale back or discontinue the development of one or more of our product candidates.
As discussed in our Annual Report on Form 10-K, we have adopted a cryptocurrency treasury strategy in which we intend to invest in Bitcoin, Ethereum and other blockchain-linked cryptocurrencies. We intend to accumulate such cryptocurrencies as a long-term treasury asset. Our goal is to acquire and grow our overall cryptocurrency position and utilize professional treasury strategies to both increase our cryptocurrency holdings, while driving revenue via a range of staking and related yield-generating activities. In the future, we plan to evaluate additional cryptocurrency holdings and transactions, including but not limited to strategic investments and/or acquisitions of operating companies that we view as aligned with our cryptocurrency treasury strategy.
The Company plans to continue to pursue its treasury strategy during 2026, under which the principal holding in its treasury reserve on the balance sheet will be allocated to cryptocurrency, and specifically a long-term strategy of holding Ethereum, Bitcoin, BNB, Doge and/or other blockchain-linked cryptocurrencies. Additionally, we intend to monitor ongoing developments in the regulatory environment around cryptocurrencies, including pending federal legislation, and may modify or expand our treasury strategy to the extent we determine doing so would comply with federal rules and regulations and would not give rise to a requirement that the Company register as an investment company under the 1940 Act. Although we believe that Ethereum, Bitcoin, BNB, Doge, and/or other blockchain-linked cryptocurrencies in which we have invested or may invest are based on proven blockchain technology and supported by established infrastructure pertaining to custody and transacting in such cryptocurrencies, our cryptocurrency treasury strategy will be subject to the risks described in the section of the Annual Report on Form 10-K titled “Risk Factors” under the heading “Risks Related to Cryptocurrency”.
Recent Developments
Vivasor Stock Repurchase Agreement
On July 18, 2026, the Company entered into a stock repurchase agreement (the “Vivasor Repurchase Agreement”) with Vivasor, pursuant to which the Company agreed to sell to Vivasor (i) 6,101,468 shares of Vivasor’s Series A-1 Preferred Stock, par value $0.00001 per share, and (ii) 355,919 shares of Vivasor’s Series A-2 Preferred Stock, par value $0.00001 per share, in each case which had been previously acquired by the Company in January 2026 (such previously acquired shares, collectively, the “Subject Shares”). Vivasor will purchase the Subject Shares from the Company for an aggregate purchase price of $12 million payable by wire transfer, by assignment of the shares of common stock of Datavault held by Vivasor, Inc., a subsidiary of Vivasor, or by any combination of such methods (the “Purchase Price”). The Vivasor Repurchase Agreement provides that the Purchase Price will be paid in tranches as follows: (i) $1.0 million on effective date which has been paid; (ii) $5.0 million at any time on or before September 30, 2026; (iii) $2.0 million at any time after September 30, 2026 but on or before December 31, 2026; (iv) $2.0 million at any time after December 31, 2026 but on or before March 31, 2027; and (v) $1,999,960.07 at any time after March 31, 2027 but on or before June 30, 2027.
Upon closing of the Vivasor Repurchase Agreement, the Company will deconsolidate Vivasor and Vivasor's balances will be removed from the Company's consolidated balance sheets. As of June 30, 2026, balances for Vivasor include $0.5 million for cash and cash equivalents, $12.0 million for property and equipment, net, $3.9 million for inventory, $20.0 million for the Datavault license, $15.3 million for investment in Datavault, $37.0 million accounts payable, $39.9 million short-term debt, net of debt financing discount, $8.8 million accrued purchases, and $0.7 million accrued expenses.
iHolding Group LLP Term Sheet
On July 3, 2026, the Company and iHolding Group LLP (“iHolding”) entered into a term sheet, pursuant to which iHolding would purchase an aggregate of 6,666,667 shares of Common Stock at $15.00 per share, for an aggregate purchase price equal to $100.0 million. Also on July 3, 2026, Semnur and iHolding entered into a term sheet, in which iHolding agreed to invest $100 million into Semnur through the purchase of newly issued common shares of Semnur at $10.00 per share, representing approximately 10,000,000 newly issued shares. Both term sheets have no fixed completion date.
The proposed investments remain subject to further negotiation between the Company and iHolding, the completion of customary due diligence, the execution of definitive agreements, board approvals, and other customary closing conditions, including receipt of the Company's stockholders' approval and any required regulatory approvals.
Components of Our Results of Operations
Net Revenue
Net revenue primarily consists of product sales of ZTlido and ELYXYB in the United States and contract service revenue. For product sales of ZTlido and ELYXYB, we record gross-to-net sales adjustments for government and commercial rebates, chargebacks, wholesaler and distributor fees, sales returns, special marketing programs, and prompt payment discounts. We expect that any net revenue we generate will fluctuate from year to year as a result of the unpredictability of the demand for our product.
Operating Costs and Expenses
Cost of Revenue
Cost of revenue primarily consists of the cost of purchasing ZTlido, ELYXYB, cost of fulfilling custom orders such as raw materials, labor to develop drug compounds that can be developed further to be used at clinical trials by our customers, inventory write-downs related to expiration dates for on-hand inventory, cost of shipments, and royalty payments to our manufacturers. We expect the cost of revenue to fluctuate with related net sales revenue.
Research and Development Expenses
Research and development expenses are expensed when incurred and consist primarily of costs incurred for our research activities, including the development of our product candidates, and include:
- costs related to clinical trials;
- salaries, benefits and other related costs, including stock-based compensation expense for personnel engaged in research and development functions; and
- costs related to outside consultants.
We expect our research and development expenses to increase, as we will incur incremental expenses associated with our product candidates that are currently under development and in clinical trials. Product candidates in later stages of clinical development generally have higher development costs, primarily due to the increased size and duration of later-stage clinical trials. Accordingly, we expect to incur significant research and development expenses in connection with our clinical trials for SEMDEXA, SP-103 and SP-104.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of costs related to our contract sales force, salaries and other related costs, including stock-based compensation, for personnel in our executive, marketing, finance, corporate and business development and administrative functions. Selling, general and administrative expenses also include professional fees for legal, patent, accounting, auditing, tax and consulting services, travel expenses and facility-related expenses, which include direct depreciation costs.
We expect that our selling, general and administrative expenses will vary year-over-year in the future as we adapt our commercial strategies to changes in the business environment. We also expect to incur increased expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC, listing standards applicable to companies listed on a national securities exchange, additional insurance expenses, investor relations activities and other administrative and professional services. We also expect to adjust the size of our administrative, finance and legal functions to adapt to the changes above and the anticipated growth of our business.
Intangible Amortization Expense
Intangible amortization expense consists of the amortization expense of intangible assets recognized on a straight-line basis over the estimated useful lives of the assets. Our intangible assets, excluding goodwill, are composed of patent rights, acquired technology, acquired licenses and assembled workforce.
Legal Settlements
Legal settlements consist of gains on litigation settlements. We recognized $0.1 million in gains on litigation settlements for the six months ended June 30, 2025, with no comparable activity for the six months ended June 30, 2026. See Note 12 titled “Commitments and Contingencies” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Other (Income) Expense
(Gain) Loss on Derivative Liability
(Gain) loss on derivative liability includes the remeasurement of the derivative warrant liability. See Note 5 titled “Fair Value Measurements” to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Loss on Compound Derivative of Scilex-St. James Loans
Loss on compound derivative of Scilex-St. James Loans relates to the termination of the Scilex-St. James Loan Agreement on March 16, 2026.
Change in Fair Value of Debt and Liability Instruments
Change in fair value of debt and liability instruments includes the remeasurement of (i) the senior secured promissory note the Company issued to Oramed Pharmaceuticals, Inc. (“Oramed”) in September 2023 in the principal amount of $101.9 million (the “Oramed Note”) with $29.5 million principal amount and paid in kind interest outstanding as of June 30, 2026, (ii) the senior secured convertible notes issued in October 2024 in the principal amount of $50.0 million (the “Tranche B Notes”) with $12.6 million principal amount outstanding as of June 30, 2026, (iii) the purchased revenue liability associated with the Purchase and Sale Agreement (the “ZTlido Royalty Purchase Agreement”) that we entered into in October 2024 with certain institutional investors (collectively, the “ZTlido Royalty Investors”) and Oramed and (iv) the purchased revenue liability associated with the Purchase and Sale Agreement (the “Gloperba-Elyxyb Royalty Purchase Agreement”) that we entered into in February 2025 with certain institutional investors (collectively, the “Gloperba-Elyxyb Royalty Investors”) and Oramed. See Note 5 titled “Fair Value Measurements” to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Loss on Foreign Currency Exchange
Loss on foreign currency exchange relates to foreign exchange (gains) losses on payments made to our foreign supplier, Itochu Chemical Frontier Corporation (“Itochu”), a manufacturer and supplier of lidocaine tape products, including ZTlido and SP-103.
Unrealized Loss on Digital Assets, net
Unrealized loss on digital assets, net relates to unrealized losses on Bitcoin and other digital coins held during the period, which are remeasured at fair value each reporting period with changes recognized in earnings. See Note 5 titled “Fair Value Measurements” to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Unrealized Loss on Equity Method Investments carried at fair value, net
Unrealized loss on equity method investments (or “EMI”) relates to unrealized losses on our investment in Datavault accounted for using the equity method. See Note 5 titled “Fair Value Measurements” to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Realized (Gain) Loss on Equity Method Investments carried at fair value, net
Realized (gain) loss on equity method investments (or “EMI”) related to realized gains and losses on our investment in Datavault accounted for using the equity method. See Note 5 titled “Fair Value Measurements” to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Realized (Gain) Loss on Securities
Realized (gain) loss on securities related to realized gains and losses on AARDVARK Therapeutics series B preferred securities sold during the period.
Interest Expense
Interest expense for the three and six months ended June 30, 2026, primarily consists of interest on Vivasor debts, interest on the balances due for government and commercial rebate programs, interest related to the deferred consideration for the GLOPERBA license acquired from Romeg in 2022.
Interest expense for the three and six months ended June 30, 2025 consists of interest on the balances due for government and commercial rebate programs and interest related to the deferred consideration for the GLOPERBA license acquired from Romeg in 2022. Government rebate programs include state Medicaid drug rebate programs, and commercial rebate programs relate to contractual agreements with commercial healthcare providers, under which we pay rebates for access to and position on that provider's patient drug formulary.
Other Expense, Net
Other expense, net for the three and six months ended June 30, 2026, primarily consists of change in fair value related to the Datavault common stock warrant asset.
Results of Operations for the Three Months ended June 30, 2026 and 2025
The following tables summarize our results of operations for the three months ended June 30, 2026 and 2025 (in thousands):
| Statements of Operations Data: | Three Months Ended June 30, 2026 | 2025 | Changes |
|---|---|---|---|
| Net revenue | $7,642 | $9,896 | $(2,254) |
| Operating costs and expenses: | |||
| Cost of revenue | 3,677 | 3,272 | 405 |
| Research and development | 3,336 | 6,187 | (2,851) |
| Selling, general and administrative | 27,960 | 19,841 | 8,119 |
| Intangible amortization | 2,092 | 1,008 | 1,084 |
| Legal settlements | — | 95 | (95) |
| Total operating costs and expenses | 37,065 | 30,403 | 6,662 |
| Loss from operations | (29,423) | (20,507) | (8,916) |
| Other (income) expense, net: | |||
| Loss on derivative liability | 6,644 | 12,375 | (5,731) |
| Loss on compound derivative of Scilex-St. James Loans | 6,930 | — | 6,930 |
| Change in fair value of debt and liability instruments | 232 | 8,366 | (8,134) |
| Loss on foreign currency exchange | 150 | 99 | 51 |
| Unrealized loss on digital assets, net | 9,258 | — | 9,258 |
| Unrealized loss on equity method investments carried at fair value, net | 50,737 | — | 50,737 |
| Realized loss on equity method investments carried at fair value, net | 5,254 | — | 5,254 |
| Realized gain on securities | (5) | — | (5) |
| Interest Expense | 6,104 | 2,682 | 3,422 |
| Other expense, net | 252 | — | 252 |
| Total other (income) expense, net | 85,556 | 23,522 | 62,034 |
| Loss before income taxes | (114,979) | (44,029) | (70,950) |
| Income tax expense | 7 | 19 | (12) |
| Net loss | $(114,986) | $(44,048) | $(70,938) |
Comparison of the Three Months Ended June 30, 2026 and 2025
Net Revenue
The following table summarizes net revenue by product for the three months ended June 30, 2026 and 2025 (in thousands):
| ZTlido | Three Months Ended June 30, 2026 | 2025 | Increase (Decrease) |
|---|---|---|---|
| Net Revenue | $5,017 | $9,055 | $(4,038) |
| ELYXYB | |||
| Net Revenue | 1,144 | 910 | 234 |
| GLOPERBA | |||
| Net Revenue | — | (69) | 69 |
| Vivasor Contract Revenue | |||
| Net Revenue | 1,481 | — | 1,481 |
| Total Net Revenue | $7,642 | $9,896 | $(2,254) |
Net revenue for the three months ended June 30, 2026 and 2025 was $7.6 million and $9.9 million, respectively. The decrease of $2.3 million was primarily related to a $4.0 million decrease in net product sales of ZTlido, partially offset by $1.5 million net contract revenue from Vivasor, a $0.2 million increase in net product sales of ELYXYB and a $0.1 million favorable change in GLOPERBA net revenue. The decrease in net sales for our commercial products was mainly driven by a delay in ZTlido's inventory shipment from Japan.
Cost of Revenue
| ZTlido | Three Months Ended June 30, 2026 | 2025 | Increase (Decrease) |
|---|---|---|---|
| Cost of Revenue | $1,443 | $1,504 | $(61) |
| Cost of Revenue - Royalties | 973 | 1,611 | (638) |
| Other Cost of Revenue | — | 16 | (16) |
| Total ZTlido | 2,416 | 3,131 | (715) |
| ELYXYB | |||
| Cost of Revenue | 50 | 65 | (15) |
| Cost of Revenue - Royalties | 92 | 73 | 19 |
| Total ELYXYB | 142 | 138 | 4 |
| GLOPERBA | |||
| Cost of Revenue | — | 3 | (3) |
| Total GLOPERBA | — | 3 | (3) |
| Vivasor Contract Revenue | |||
| Cost of Revenue | 1,119 | — | 1,119 |
| Total Vivasor Contract Revenue | 1,119 | — | 1,119 |
| Total Cost of Revenue | $3,677 | $3,272 | $405 |
Cost of revenue for the three months ended June 30, 2026 and 2025 was $3.7 million and $3.3 million, respectively. Cost of revenue increased by $0.4 million, mainly due to cost related to Vivasor contract revenue of $1.1 million, partially offset by a decrease of $0.7 million in ZTlido's cost of revenue, primarily driven by a decrease in gross product sales due to delayed inventory shipment.
Research and Development Expenses
The following table summarizes research and development expenses by project for the three months ended June 30, 2026 and 2025 (in thousands):
| SP-102 | Three Months Ended June 30, 2026 | 2025 | Increase (Decrease) |
|---|---|---|---|
| Contracted R&D | $517 | $102 | $415 |
| Personnel | 610 | 365 | 245 |
| Other | 122 | 35 | 87 |
| Total SP-102 | 1,249 | 502 | 747 |
| SP-103 | |||
| Contracted R&D | 52 | 241 | (189) |
| Personnel | 150 | 234 | (84) |
| Other | 32 | 58 | (26) |
| Total SP-103 | 234 | 533 | (299) |
| SP-104 | |||
| Contracted R&D | 1 | (71) | 72 |
| Personnel | 5 | 4 | 1 |
| Other | 6 | 14 | (8) |
| Total SP-104 | 12 | (53) | 65 |
| GLOPERBA | |||
| Contracted R&D | 34 | 197 | (163) |
| Personnel | 15 | 158 | (143) |
| Other | 4 | 28 | (24) |
| Total GLOPERBA | 53 | 383 | (330) |
| ELYXYB | |||
| Contracted R&D | 73 | 122 | (49) |
| Personnel | 149 | 227 | (78) |
| Other | 50 | 41 | 9 |
| Total ELYXYB | 272 | 390 | (118) |
| R&D Discovery Project | |||
| Contracted R&D | 503 | 32 | 471 |
| Personnel | 515 | 40 | 475 |
| Other | 498 | 4,360 | (3,862) |
| Total R&D Discovery Project | 1,516 | 4,432 | (2,916) |
| Total Research and Development Expenses | $3,336 | $6,187 | $(2,851) |
Research and development expenses for the three months ended June 30, 2026 and 2025 were $3.3 million and $6.2 million, respectively. The decrease was primarily attributed to the acquisition costs for the KDS2010 license in 2025, partially offset by increased staffing cost related to SP-102.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the three months ended June 30, 2026 and 2025 were $28.0 million and $19.8 million, respectively. The increase of approximately $8.2 million was primarily due to a $2.6 million increase in legal expenses, a $1.3 million increase in advisory and financing expense,a $1.1 million increase in facility expense, a $1.1 million of settlement expense related to Vivasor repurchasing its preferred shares from third-party shareholders, a $1.2 million increase in contract services, a $0.5 million increase in insurance expense, a $0.4 million increase in product promotions expense, a $0.3 million increase in personnel expenses, and a $0.2 million increase in other expense, partially offset by a $0.6 million decrease in travel expenses in the three months ended June 30, 2026.
Intangible Amortization Expense
Intangible amortization expense for the three months ended June 30, 2026 and 2025 was $2.1 million and $1.0 million, respectively. The increase of $1.1 million is related to the amortization of the Datavault acquired license and the EOS Technology Holdings patent. See Note 3 titled “Acquisitions” and Note 7 titled “Goodwill and Intangible Assets” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.
Legal Settlements
Legal settlements for the three months ended June 30, 2026 and 2025 were nil and $0.1 million, respectively. The decrease was attributed to payments made for a litigation settlement that was entered into during the second quarter of 2025. The terms of the settlement are confidential. See Note 12 titled “Commitments and Contingencies” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Loss on Derivative Liability
Loss on derivative liability for the three months ended June 30, 2026 and 2025 was $6.6 million and $12.4 million, respectively. The loss recognized during the three months ended June 30, 2026 was attributed to the change in the fair value of the derivative warrant liability associated with the Private Warrants, the February 2024 BDO Firm Warrants, the Deposit Warrant, the October 2024 Noteholder Warrants, the December 2024 RDO Common Warrants, the Exchange Warrants (as defined below), September 2025 Warrants, November 2025 Warrants, February 2026 Warrants (each as defined below). The loss recognized during the three months ended June 30, 2025 was attributed to the change in the fair value of the derivative warrant liability associated with the Private Warrants, the February 2024 BDO Firm Warrants, the April 2024 RDO Common Warrants, the Deposit Warrant, the October 2024 Noteholder Warrants and the December 2024 RDO Common Warrants (each as defined below).
Loss on compound derivative of Scilex-St. James Loans
Loss on compound derivative of Scilex-St. James Loans for the three months ended June 30, 2026 and 2025 was $6.9 million and nil, respectively. Compound derivative of $6.9 million for the three months ended June 30, 2026 was attributed to the change in the fair value for 10,000,000 shares of Datavault common stock that was related to termination of the Scilex-St. James Loan Agreement on March 16, 2026.
Change in Fair Value of Debt and Liability Instruments
Change in fair value of debt and liability instruments for the three months ended June 30, 2026 and 2025 was $0.2 million and $8.4 million, respectively. The loss recognized during the three months ended June 30, 2026 was attributed to losses of $0.1 million for the Tranche B Notes, and $0.2 million for the purchased revenue liability pursuant to the ZTlido Royalty Purchase Agreement, partially offset by gain of $0.1 million in change in fair value of the Oramed Note. The loss recognized during the three months ended June 30, 2025 was attributed to losses of $3.5 million for the Oramed Note, $0.6 million for the purchased revenue liability pursuant to the ZTlido Royalty Purchase Agreement, $0.1 million for the purchased revenue liability pursuant to the Gloperba-Elyxyb Royalty Purchase Agreement and $4.2 million in change in fair value of the Tranche B Notes.
Loss on Foreign Currency Exchange
Loss on foreign currency exchange of $0.2 million and $0.1 million for the three months ended June 30, 2026 and 2025, respectively, relates to foreign exchange (gains) losses on payments made to our foreign supplier, Itochu Chemical Frontier Corporation (“Itochu”), a manufacturer and supplier of lidocaine tape products, including ZTlido and SP-103.
Unrealized Loss on Digital Assets, net
Unrealized loss on digital assets for the three months ended June 30, 2026 and 2025 was $9.3 million, and nil, respectively. The unrealized loss during the three months ended June 30, 2026, was attributed to the unrealized loss on digital assets held, which had depreciated in value.
Unrealized Loss on Equity Method Investments carried at fair value, net
Unrealized loss on equity method investments for the three months ended June 30, 2026 and 2025 was $50.7 million and nil, respectively. The unrealized loss during the three months ended June 30, 2026 was attributed to the unrealized loss on Datavault investment held that had depreciated in value.
Realized Loss on Equity Method Investments carried at fair value, net
Realized loss on equity method investments for the three months ended June 30, 2026 and 2025 was $5.3 million and nil, respectively. The realized loss during the three months ended June 30, 2026 was attributed to the realized loss on Datavault investment sold that had depreciated in value, partially offset by realized gain on write-off of 10,000,000 shares of Datavault common stock that was related to termination of the Scilex-St. James Loan Agreement on March 16, 2026.
Realized Gain on Securities
Realized gain on securities related to realized gains on AARDVARK Therapeutics series B preferred securities sold during the period.
Interest Expense
Interest expense for the three months ended June 30, 2026 was $6.1 million, primarily consisted of interest on Vivasor debts, interest on the balances due for government and commercial rebate programs, and interest related to the deferred consideration for GLOPERBA license acquired from Romeg in 2022. Government rebate programs include state Medicaid drug rebate programs and commercial rebate programs relate to contractual agreements with commercial healthcare providers, under which we pay rebates for access to and position on that provider’s patient drug formulary. Other expense, net also includes a $1.0 million fee to extend the Oramed debt (refer to Note 8 for further details), and a $0.4 million decrease in the fair value of the Datavault warrant asset. Interest expense of $2.7 million for the three months ended June 30, 2025 primarily consists of the interest on the balances due for government and commercial rebate programs.
Other Expense, Net
Other expense, net for the three months ended June 30, 2026 was $0.3 million, primarily consists of change in fair value related to the Datavault common stock warrant asset.
Results of Operations for the Six Months Ended June 30, 2026 and 2025
The following tables summarize our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):
| Statements of Operations Data: | Six Months Ended June 30, 2026 | 2025 | Changes |
|---|---|---|---|
| Net revenue | $16,255 | $14,900 | $1,355 |
| Operating costs and expenses: | |||
| Cost of revenue | 8,124 | 4,656 | 3,468 |
| Research and development | 6,546 | 8,643 | (2,097) |
| Selling, general and administrative | 58,993 | 47,901 | 11,092 |
| Intangible amortization | 4,184 | 2,010 | 2,174 |
| Legal settlements | — | 95 | (95) |
| Total operating costs and expenses | 77,847 | 63,305 | 14,542 |
| Loss from operations | (61,592) | (48,405) | (13,187) |
| Other (income) expense, net: | |||
| (Gain) loss on derivative liability | (19,065) | 1,966 | (21,031) |
| Loss on compound derivative of Scilex-St. James Loans | 28,759 | — | 28,759 |
| Change in fair value of debt and liability instruments | 3,029 | 14,480 | (11,451) |
| Loss on foreign currency exchange | 429 | 95 | 334 |
| Unrealized loss on digital assets, net | 27,322 | — | 27,322 |
| Unrealized loss on equity method investments carried at fair value, net | 82,447 | — | 82,447 |
| Realized gain on equity method investments carried at fair value, net | (37,084) | — | (37,084) |
| Realized loss on securities | 3,066 | — | 3,066 |
| Interest Expense | 11,560 | 5,163 | 6,397 |
| Other income, net | (1,426) | — | (1,426) |
| Total other (income) expense, net | 99,037 | 21,704 | 77,333 |
| Loss before income taxes | (160,629) | (70,109) | (90,520) |
| Income tax expense | 7 | 19 | (12) |
| Net loss | $(160,636) | $(70,128) | $(90,508) |
78
Comparison of the Six months Ended June 30, 2026 and 2025
Net Revenue
The following table summarizes net revenue by product for the six months ended June 30, 2026 and 2025 (in thousands):
| ZTlido | Six Months Ended June 30, 2026 | 2025 | Increase (Decrease) |
|---|---|---|---|
| Net Revenue | 10,140 | $13,042 | $(2,902) |
| ELYXYB | |||
| Net Revenue | 2,275 | 1,750 | $525 |
| GLOPERBA | |||
| Net Revenue | — | 108 | $(108) |
| Vivasor Contract Revenue | |||
| Net Revenue | 3,840 | — | $3,840 |
| Total Net Revenue | $16,255 | $14,900 | $1,355 |
Net revenue for the six months ended June 30, 2026 and 2025 was $16.3 million and $14.9 million, respectively. The increase of $1.4 million was primarily related to a $3.8 million contract revenue from Vivasor and an increase of $0.5 million in net product sales of Elyxyb, partially offset by a $2.9 million decrease in net product sales of ZTlido due to a delay in inventory shipment from Japan, and a $0.1 million decrease in net product sales of Gloperba.
Cost of Revenue
| ZTlido | Six Months Ended June 30, 2026 | 2025 | Increase (Decrease) |
|---|---|---|---|
| Cost of Revenue | $3,297 | $2,074 | $1,223 |
| Cost of Revenue - Royalties | 1,868 | 2,313 | (445) |
| Other Cost of Revenue | 7 | 26 | (19) |
| Total ZTlido | 5,172 | 4,413 | 759 |
| ELYXYB | |||
| Cost of Revenue | 102 | 95 | 7 |
| Cost of Revenue - Royalties | 183 | 140 | 43 |
| Total ELYXYB | 285 | 235 | 50 |
| GLOPERBA | |||
| Cost of Revenue | — | 8 | (8) |
| Total GLOPERBA | — | 8 | (8) |
| Vivasor Contract Revenue | |||
| Cost of Revenue | 2,667 | — | 2,667 |
| Total Vivasor Contract Revenue | 2,667 | — | 2,667 |
| Total Cost of Revenue | $8,124 | $4,656 | $3,468 |
Cost of revenue for the six months ended June 30, 2026 and 2025 was $8.1 million and $4.7 million, respectively. Cost of revenue increased by $2.7 million for Vivasor Contract Revenue and for ZTlido increased by $0.8 million, primarily driven by an increase in shipping cost.
Research and Development Expenses
The following table summarizes research and development expenses by project for the six months ended June 30, 2026 and 2025 (in thousands):
| SP-102 | Six Months Ended June 30, 2026 | 2025 | Increase (Decrease) |
|---|---|---|---|
| Contracted R&D | $1,272 | $177 | $1,095 |
| Personnel | 969 | 469 | 500 |
| Other | 274 | 43 | 231 |
| Total SP-102 | 2,515 | 689 | 1,826 |
| SP-103 | |||
| Contracted R&D | 199 | 529 | (330) |
| Personnel | 357 | 533 | (176) |
| Other | 82 | 104 | (22) |
| Total SP-103 | 638 | 1,166 | (528) |
| SP-104 | |||
| Contracted R&D | 2 | (47) | 49 |
| Personnel | 14 | 65 | (51) |
| Other | 14 | 23 | (9) |
| Total SP-104 | 30 | 41 | (11) |
| GLOPERBA | |||
| Contracted R&D | 72 | 269 | (197) |
| Personnel | 141 | 380 | (239) |
| Other | 9 | 618 | (609) |
| Total GLOPERBA | 222 | 1,267 | (1,045) |
| ELYXYB | |||
| Contracted R&D | 275 | 199 | 76 |
| Personnel | 318 | 513 | (195) |
| Other | 114 | 187 | (73) |
| Total ELYXYB | 707 | 899 | (192) |
| R&D Discovery Project | |||
| Contracted R&D | 591 | 67 | 524 |
| Personnel | 1,006 | 147 | 859 |
| Other | 837 | 4,367 | (3,530) |
| Total R&D Discovery Project | 2,434 | 4,581 | (2,147) |
| Total Research and Development Expenses | $6,546 | $8,643 | $(2,097) |
Research and development expenses for the six months ended June 30, 2026 and 2025 were $6.5 million and $8.6 million, respectively. The decrease was primarily attributed to additional expenses related to KDS2010 purchased by Scilex Bio in 2025.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the six months ended June 30, 2026 and 2025 were $59.0 million and $47.9 million, respectively. The increase of approximately $11.1 million was primarily due to a $4.1 million increase in advisory and financing expenses, a $2.2 million increase in facility expense, a $1.9 million increase in contract service, a $2.1 million increase in legal fees, a $1.1 million increase in subscription expense, a $1.1 million of settlement expense related to Vivasor repurchasing its preferred shares from third-party shareholders, a $1.1 million increase in depreciation expense mainly related to Vivasor, and $0.2 million increase in other expenses, partially offset by a $1.4 million decrease in personnel cost and a $1.3 million decrease in travel cost in the six months ended June 30, 2026.
Intangible Amortization Expense
Intangible amortization expense for each of the six months ended June 30, 2026 and 2025 was $4.2 million and $2.0 million, respectively. The increase of $2.2 million is related to the amortization of the Datavault acquired license and the EOS Technology Holdings patent (see Note 3 titled “Acquisitions” and Note 7 titled “Goodwill and Intangible Assets” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information).
Legal Settlements
Legal settlements for the six months ended June 30, 2026 and 2025 were nil and $0.1 million, respectively. The $0.1 million payments made for a litigation settlement that was entered into during the second quarter of 2025, the terms of which are confidential. See Note 12 titled “Commitments and Contingencies” to our consolidated financial statements in our Annual Report on Form 10-K and Note 12 titled “Commitments and Contingencies” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
(Gain) Loss on Derivative Liability
(Gain) Loss on derivative liability for the six months ended June 30, 2026 and 2025 were ($19.1) million and $2.0 million, respectively. The gain recognized during the six months ended June 30, 2026 was attributed to the change in the fair value of the derivative warrant liability associated with the Private Warrants, the February 2024 BDO Firm Warrants, the Deposit Warrant, the October 2024 Noteholder Warrants, the December 2024 RDO Common Warrants, the Exchange Warrants (as defined below), September 2025 Warrants, November 2025 Warrants, February 2026 Warrants (each as defined below). The loss recognized during the six months ended June 30, 2025 was attributed to the change in the fair value of the derivative warrant liability associated with the Private Warrants, the February 2024 BDO Firm Warrants, the April 2024 RDO Common Warrants, the Deposit Warrant, the October 2024 Noteholder Warrants and the December 2024 RDO Common Warrants.
Loss on compound derivative of Scilex-St. James Loans
Loss on compound derivative of Scilex-St. James Loans for the six months ended June 30, 2026 and 2025 was $28.8 million and nil, respectively. Compound derivative of $28.8 million for the six months ended June 30, 2026 was attributed to the termination of the Scilex-St. James Loan Agreement on March 16, 2026.
Change in Fair Value of Debt and Liability Instruments
Change in fair value of debt and liability instruments for the six months ended June 30, 2026 and 2025 was $3.0 million and $14.5 million, respectively. The loss recognized during the six months ended June 30, 2026 was attributed to losses of $1.1 million for the Oramed Note, $1.0 million in change in fair value of the Tranche B Notes $0.9 million for the purchased revenue liability pursuant to the ZTlido Royalty Purchase Agreement, and $0.2 million for the purchased revenue liability pursuant to the Gloperba-Elyxyb Royalty Purchase Agreement. The loss recognized during the six months ended June 30, 2025, was attributed to losses of $6.3 million for the Oramed Note, $1.4 million for the purchased revenue liability pursuant to the ZTlido Royalty Purchase Agreement, $0.1 million for the purchased revenue liability pursuant to the Gloperba-Elyxyb Royalty Purchase Agreement and $6.7 million in change in fair value of the Tranche B Notes.
Loss on Foreign Currency Exchange
Loss on foreign currency exchange of $0.4 million and $0.1 million for the six months ended June 30, 2026 and 2025, respectively, relates to foreign exchange (gains) losses on payments made to our foreign supplier, Itochu Chemical Frontier Corporation (“Itochu”), a manufacturer and supplier of lidocaine tape products, including ZTlido and SP-103.
Unrealized Loss on Digital Assets, net
Unrealized loss on digital assets for the six months ended June 30, 2026 and 2025 was $27.3 million, and nil, respectively. The unrealized loss during the six months ended June 30, 2026, was attributed to the unrealized loss on digital assets held, which had depreciated in value.
Unrealized Loss on Equity Method Investments carried at fair value, net
Unrealized loss on equity method investments for the six months ended June 30, 2026 and 2025 was $82.4 million and nil, respectively. The unrealized loss during the six months ended June 30, 2026 was attributed to the unrealized loss on Datavault investment held that had depreciated in value.
Realized (Gain) on Equity Method Investments carried at fair value, net
Realized gain on equity method investments for the six months ended June 30, 2026 and 2025 was $37.1 million and nil, respectively. The realized gain during the six months ended June 30, 2026 was attributed to the realized gain on Datavault investment sold that had appreciated in value.
Realized Loss on Securities
Loss on securities for the six months ended June 30, 2026 and 2025 was $3.1 million and nil, respectively. The loss during the six months ended June 30, 2026 was related to realized losses on AARDVARK Therapeutics series B preferred securities sold during the period.
Interest Expense
Interest expense for the six months ended June 30, 2026 and 2025 was $11.6 million and $5.2 million, respectively. Interest expense for the six months ended June 30, 2026 primarily consists of interest on Vivasor debts, interest on the balances due for government and commercial rebate programs, and interest related to the deferred consideration for GLOPERBA license acquired from Romeg in 2022. Government rebate programs include state Medicaid drug rebate programs and commercial rebate programs relate to contractual agreements with commercial healthcare providers, under which we pay rebates for access to and position on that provider’s patient drug formulary. Interest expense also includes a $1.0 million fee for the extension of the Oramed debt. Interest expense of $5.2 million for the six months ended June 30, 2025 primarily consists of the interest on the balances due for government and commercial rebate programs.
Other Income, net
Other income, net for the six months ended June 30, 2026 and 2025 was $1.4 million and nil, respectively.Other income, net for the six months ended June 30, 2026 primarily relates to the reduction of the $3.0 million AARDVARK contingent consideration liability as of December 31, 2025, by $1.5 million due to a change in fair value during the six months ended June 30, 2026. The remaining $1.5 million obligation, now fixed and determinable, was reclassified from contingent consideration to accounts payable as of June 30, 2026.
Liquidity and Capital Resources
As of June 30, 2026, we had cash and cash equivalents of approximately $0.6 million.
We have funded our operations in the six months ended June 30, 2026 primarily through equity and debt financings pursuant to the Scilex-St. James Loans (as defined below), as well as sale of Datavault common stock and collections on account receivable. We also have indebtedness pursuant to the Oramed Note and Tranche B Notes as well as deferred consideration related to the GLOPERBA license acquired from Romeg in 2022. The following table summarizes the aggregate carrying value of indebtedness of these issuances as of June 30, 2026 and December 31, 2025 (in thousands):
| June 30, 2026 | December 31, 2025 | |
|---|---|---|
| Oramed Note (outstanding principal balance and paid in kind interest: $29.5 million and $28.2 million as of June 30, 2026 and December 31, 2025, respectively) | $28,768 | $27,688 |
| Tranche B Notes (outstanding principal balance: $12.6 million and $17.9 million as of June 30, 2026 and December 31, 2025, respectively) | 12,140 | 17,500 |
| Promissory Notes | 2,231 | 3,517 |
| Purchased Revenue Liability | 8,198 | 8,400 |
| Deferred Consideration with Romeg | 2,240 | 2,448 |
| Vivasor Related Debt, net of discount (outstanding principal balance: $45.9 million and $47.0 million as of June 30, 2026 and December 31, 2025, respectively) | 39,898 | 39,020 |
| Total indebtedness | $93,475 | $98,574 |
The Oramed Note
As of June 30, 2026, the fair value of the Oramed Note outstanding was $28.8 million pursuant to the Scilex-Oramed SPA. See Note 8 titled “Debt” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.
Tranche B Notes
As of June 30, 2026, the fair value of the Tranche B Notes outstanding was $12.1 million pursuant to the Tranche B Securities Purchase Agreement. See Note 8 titled “Debt” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.
Promissory Notes
As of June 30, 2026, the carrying value of the Promissory Notes outstanding was $2.2 million pursuant to the Promissory Notes. See Note 8 titled “Debt” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.
Purchased Revenue Liability
As of June 30, 2026, the fair value of the purchased revenue liability was $8.2 million pursuant to the ZTlido Royalty Purchase Agreement and Gloperba-Elyxyb Royalty Purchase Agreement. See Note 8 titled “Debt” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.
Deferred Consideration
As of June 30, 2026, we have $2.2 million of deferred consideration related to minimum royalty payments that were included in the initial measurement of consideration transferred for the GLOPERBA license. Deferred consideration minimum royalty payments began in July 2023.
Vivasor Related Debt
As of June 30, 2026, the aggregated outstanding principal balance of the Vivasor-related debt, net of debt discount was $39.9 million pursuant to the Vivasor-related debt agreement. See Note 8 titled “Debt” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.
Scilex-St. James Loans
On December 1, 2025, the Company entered into a Non-Recourse Loan and Securities Pledge Agreement (the “Scilex-St. James Loan Agreement”) with St. James Bank & Trust Company Ltd., a corporation existing under the laws of the Bahamas (“St. James” or the “Lender”), pursuant to which the Lender agreed to loan the Company an aggregate principal amount of up to $50.0 million in one or more tranches (the “Scilex-St. James Loans”). As of June 30, 2026, the carrying value of the Scilex-St. James Loans outstanding was nil. See Note 8 titled “Debt” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.
ZTlido, ELYXYB and GLOPERBA Royalties
In February 2013, Scilex Pharma became a party to a product development agreement (as amended, the “Product Development Agreement”) with Itochu and Oishi Koseido Co., Ltd. (“Oishi” and together with Itochu, the “Developers”), pursuant to which the Developers will manufacture and supply lidocaine tape products, including ZTlido and SP-103, for Scilex Pharma. Pursuant to the Product Development Agreement, Scilex Pharma is required to make aggregate royalty payments between 25% and 35% to the Developers based on net profits. During each of the six months ended June 30, 2026 and 2025, Scilex Pharma made royalty payments in the amount of $2.4 million and $1.9 million, respectively. As of June 30, 2026 and December 31, 2025, Scilex Pharma had ending balances of accrued royalty payables of $1.6 million and $2.1 million, respectively.
In February 2023, we entered into an asset purchase agreement to acquire the rights to certain patents, trademarks, regulatory approvals, data, contracts, and other rights related to ELYXYB and its commercialization in the United States and Canada (the “ELYXYB Territory”). We are obligated to make quarterly royalty payments on net sales of ELYXYB in the ELYXYB Territory that range from high single digits to low double digits on net sales based on the volume of sales. In April 2023, we launched ELYXYB in the U.S. During the six months ended June 30, 2026 and 2025, we made royalty payments in the amount of $0.0 million and $0.1 million, respectively. As of each of June 30, 2026 and December 31, 2025, we had ending balances of accrued royalty payables of $0.4 million and $0.2 million.
On June 14, 2022, the Company entered into a License and Commercialization Agreement, as amended by that certain First Amendment to License and Commercialization Agreement, dated as of January 16, 2025 (such agreement, as amended, the “Romeg License Agreement”), with Romeg, under which the Company in-lciensed, certain intellectual property rights from Romeg with respect to the commercialization of GLOPERBA and acquired the exclusive license to use the trademark “GLOPERBA®”. As consideration for the license under the Romeg License Agreement, we are obligated to make royalty payments on net sales of GLOPERBA that range from low single digit to mid-single digit percentages based on annual net sales. During each of the six months ended June 30, 2026 and 2025, we made royalty payments in the amount of $0.3 million.
Contingent Consideration
We have $280.0 million, $13.0 million and $23.0 million in aggregate contingent consideration obligations in connection with the SEMDEXA, GLOPERBA and SP-104 acquisitions, respectively, that are contingent upon achieving certain specified milestones or the occurrence of certain events. Contingent consideration obligations consist of regulatory milestones and additional payments that will be due upon the achievement of certain amounts of net sales. See Note 3 titled “Acquisitions” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.
February 2024 Bought Deal Offering Underwriting Agreement
On February 29, 2024, the Company entered into an underwriting agreement (the “February 2024 BDO Underwriting Agreement”) with Rodman & Renshaw LLC and StockBlock Securities LLC (“StockBlock”), as representatives of the underwriters. Pursuant to the February 2024 BDO Underwriting Agreement, we sold, in an underwritten offering (the “February 2024 BDO”), 168,068 shares (the “February 2024 BDO Firm Shares”) of the Common Stock, and accompanying common warrants to purchase up to an aggregate of 168,068 shares of Common Stock (the “February 2024 BDO Firm Warrants”). Each February 2024 BDO Firm Share was sold together with a February 2024 BDO Firm Warrant at a combined public offering price of $59.50. The combined price per Firm Share and accompanying February 2024 BDO Firm Warrant paid by the February 2024 Underwriters was $54.74, which amount reflects the combined public offering price of $59.50, less underwriting discounts and commissions.
Subject to certain ownership limitations, the February 2024 BDO Common Warrants are exercisable immediately, will expire on the five-year anniversary of the date of issuance and have an exercise price of $59.50 per share. The exercise price of the February 2024 BDO Common Warrants is subject to certain adjustments, including (but not limited to) stock dividends, stock splits, combinations and reclassifications of the Common Stock.
In connection with the February 2024 BDO, pursuant to the February 2024 BDO Underwriting Agreement, the Company issued the February 2024 BDO Representative Warrants to the February 2024 BDO StockBlock, allowing them to purchase up to an aggregate of 13,446 shares of Common Stock (which represents 8.0% of the aggregate number of February 2024 BDO Firm Shares sold in the February 2024 BDO). The February 2024 BDO Representative Warrants are immediately exercisable and have the same terms as the February 2024 BDO Common Warrants described above, except that the exercise price of the February 2024 BDO Representative Warrants is $74.38 per share, which represents 125% of the combined public offering price per February 2024 BDO Firm Shares and accompanying February 2024 BDO Firm Warrants. We also agreed to pay certain expenses of the February 2024 BDO Representatives in connection with the February 2024 BDO, including their legal fees and out-of-pocket expenses up to $0.2 million and up to $15,950 for clearing expenses.
The February 2024 BDO Shares, the February 2024 BDO Warrants and the shares of Common Stock issuable upon exercise of the February 2024 BDO Warrants were offered and sold by us pursuant to an effective shelf registration statement on Form S-3 (which was initially filed with the SEC on December 22, 2023, as amended, and was declared effective on January 11, 2024 (File No. 333-276245) (the “Shelf S-3 Registration Statement”)), a base prospectus dated January 11, 2024, and a prospectus supplement dated February 29, 2024.
April 2024 Registered Direct Offering
On April 23, 2024, the Company entered into a securities purchase agreement (the “April 2024 RDO Purchase Agreement”) with the investor named therein, pursuant to which we sold and issued, in a registered direct offering (the “April 2024 RDO”): (i) an aggregate of 34,286 shares (the “April 2024 RDO Shares”) of Common Stock, and (ii) common warrants to purchase up to 34,286 shares of Common Stock (the “April 2024 RDO Common Warrants”). The offering price per share and accompanying April 2024 RDO Common Warrant to purchase one share of Common Stock was $35.00, for aggregate gross proceeds to us of $15.0 million, before deducting the placement agent fees and other offering expenses.
Subject to certain ownership limitations, the April 2024 RDO Common Warrants are exercisable on the six-month anniversary from the date of issuance, will expire on the five-year anniversary of the date of issuance and have an exercise price of $38.50 per share. The exercise price of the April 2024 RDO Common Warrants is subject to certain adjustments, including stock dividends, stock splits, combinations and reclassifications of the Common Stock.
StockBlock and its affiliate, Rodman & Renshaw LLC, acted as exclusive placement agents (the “April 2024 RDO Placement Agents”) in connection with the April 2024 RDO. As compensation for such placement agent services, we paid the April 2024 RDO Placement Agents an aggregate cash fee equal to 8.0% of the gross proceeds actually received by us from the April 2024 RDO. We also reimbursed the April 2024 RDO Placement Agents $100,000 for actual, reasonable and documented fees and expenses, inclusive of fees and expenses of legal counsel and out-of-pocket expenses and $15,950 for clearing expenses. We also issued to the April 2024 RDO Placement Agents or their respective designees common warrants, substantially in the form of the April 2024 RDO Common Warrants, to purchase up to 34,286 shares of Common Stock (the “April 2024 RDO Placement Agent Warrants”) and together with the April 2024 RDO Common Warrants, the April 2024 RDO Warrants, representing up to 8.0% of the total number of the April 2024 RDO Shares issued in the April 2024 RDO. The April 2024 RDO Placement Agent Warrants have an exercise price of $43.75 per share (which represents 125% of the combined offering price per share of Common Stock and the April 2024 RDO Common Warrant sold in the April 2024 RDO), will become exercisable on the six-month anniversary of the date of issuance and expire five years from the commencement of sales in the April 2024 RDO.
The April 2024 RDO Shares, the April 2024 RDO Warrants, and the shares of Common Stock issuable upon exercise of such warrants were offered and sold by us pursuant to the Shelf S-3 Registration Statement, a base prospectus dated January 11, 2024, and a prospectus supplement dated April 23, 2024. The April 2024 RDO closed on April 25, 2024.
Tranche B Notes
On October 7, 2024, the Company entered into a securities purchase agreement (the “Tranche B Securities Purchase Agreement”) with certain institutional investors (collectively, “the Tranche B Investors”) and Oramed (together with, the Tranche B Investors, the “Tranche B Noteholders”), to refinance a portion of the Oramed Note and pay off certain other indebtedness. Pursuant to the Tranche B Securities Purchase Agreement, we agreed to issue and sell, in a registered offering directly to the Tranche B Noteholders: (i) the Tranche B Notes, which notes will mature on the two-year anniversary of the issuance date and will be convertible into shares of our Common Stock at a conversion price equal to $38.15 per share (which was automatically reduced to $36.40 per share of Common Stock subsequent to the December 2024 RDO (as defined below) in accordance with the terms of such notes) and (ii) warrants to purchase up to 214,284 shares of our Common Stock (the “October 2024 Noteholder Warrants”).
In exchange for the issuance of the Tranche B Notes to the Tranche B Investors, the Company has received an aggregate amount in cash of $22.5 million, excluding fees and expenses payable by the Company. In consideration for the Tranche B Notes issued to Oramed, the Company has received from Oramed an exchange and reduction of the principal balance under the Oramed Note of $22.5 million.
The October 2024 Noteholder Warrants are immediately exercisable for cash at a current exercise price equal to $36.40 per share and will expire five years from the issuance date. The October 2024 Noteholder Warrants issued to the Tranche B Investors are initially exercisable for 107,142 shares of Common Stock in the aggregate.
Pursuant to the terms and conditions contained in the Tranche B Securities Purchase Agreement, we also agreed to reimburse the Tranche B Investors for all reasonable costs and expenses incurred by them or their affiliates in connection with the Tranche B Securities Purchase Agreement, the Tranche B Notes, the October 2024 Noteholder Warrants, the ZTlido Royalty Purchase Agreement and certain other transaction documents, and an aggregate amount of $1.0 million in non-accountable legal fees of outside counsel and special finance and collateral counsel, which shall be withheld by the Tranche B Investors from its purchase price at the closing of the transaction. We shall also be responsible for the payment of a $2.0 million fee to the placement agent in addition to the payment of any placement agent’s reasonable fees, financial advisory fees relating to or arising out of the transactions contemplated by the Tranche B Securities Purchase Agreement. In addition, in conjunction with and pursuant to the letter agreement we entered into with Oramed, dated as of October 2, 2024 (the “Tranche B Letter Agreement”), we are also responsible for the payment of legal fees of outside counsel for Oramed relating to or arising out of the transactions contemplated by the Tranche B Letter Agreement, and the payment date extensions described under the Tranche B Letter Agreement. We shall also be responsible for the payment of any fees of the placement agents and the legal fees incurred thereby relating to or arising out of the transactions contemplated by the Tranche B Securities Purchase Agreement.
In connection with the offering of the Tranche B Notes, the Company issued to StockBlock and its affiliate, Rodman & Renshaw LLC (the “October 2024 Placement Agents”) or their respective designees, (i) 62,794 shares of Common Stock (the “October 2024 Placement Agent Shares”) and (ii) warrants to purchase up to 104,848 shares of Common Stock (the “October 2024 Placement Agent Warrants”). The October 2024 Placement Agent Shares were subject to a 120-day lock-up, which is now expired. In addition, during such 120-day period, the October 2024 Placement Agents (whether directly or indirectly through their respective affiliates) are prohibited from hedging, pledging or similar transactions and from short-selling our securities, subject to certain exceptions. The October 2024 Placement Agent Warrants will have the same terms as the October 2024 Noteholder Warrants, except that the October 2024 Placement Agents have agreed not to exercise the October 2024 Placement Agent Warrants for a period of 180 days following the date of issuance, which is now expired.
Pursuant to the Tranche B Notes, commencing on January 2, 2025, we were required to redeem in cash (the “First Amortization Payment”) such portion of the principal amount of the Tranche B Notes equal to each Tranche B Noteholder’s Holder Pro Rata Amount (as defined in the Tranche B Notes) of $6,250,000 per fiscal quarter at a redemption price equal to 100% of such Amortization Amount (as defined in the Tranche B Notes).
On January 2, 2025, we entered into a deferral and consent letter with each of (i) Nomis Bay Ltd and BPY Limited (the “Nomis Bay Consent”), (ii) Oramed (the “Oramed Consent”) and (iii) 3i, LP (the “3i Consent” and, collectively with the Nomis Bay Consent and the Oramed Consent, the “Tranche B Consents”), respectively, pursuant to which the Tranche B Noteholders agreed to defer our obligation to make the First Amortization Payment until January 31, 2025, and then further to October 8, 2026. In consideration of such deferral, (i) SCLX Stock Acquisition JV LLC, a single purpose bankruptcy-remote entity that is the Company's indirect wholly owned subsidiary (“SCLX JV”) delivered to the Tranche B Noteholders an aggregate of 142,855 shares of Common Stock held by SCLX JV, (ii) we paid an aggregate of $1.1 million in respect of a portion of the First Amortization Payment and related make-whole interest, and (iii) we entered into the Gloperba-Elyxyb Royalty Purchase Agreement.
Oramed Warrant
Pursuant to the Tranche B Notes, we were required to make an amortization payment on October 1, 2025 (the “Second Amortization Payment”) to Oramed. On December 31, 2025, the Company entered into a commitment letter with Oramed pursuant to which Oramed agreed to purchase warrants to acquire 50,000 shares of common stock of Scilex, par value $0.0001 per share, at an exercise price of $20.00 per share (in each case subject to adjustment for recapitalizations, stock splits, stock dividends and similar types of transactions), in exchange for which Oramed deferred its right to receive the Second Amortization Payment. On February 19, 2026, the Company issued to Oramed a new warrant to purchase an aggregate of 100,000 shares of Common Stock (the “February 2026 Warrant”) at an initial exercise price of $20.00 per share. The deferred amortization payment was made to Oramed in November 2025.
December 2024 Registered Direct Offering
On December 11, 2024, we entered into a securities purchase agreement (the “December 2024 RDO Purchase Agreement”) with the investors named therein, pursuant to which we agreed to sell and issue, in a registered direct offering (the “December 2024 RDO”): (i) an aggregate of 753,009 shares of Common Stock, (ii) pre-funded warrants to purchase up to 68,604 shares of Common Stock (the “December 2024 RDO Pre-Funded Warrants”) and (iii) common warrants to purchase up to 1,642,871 shares of Common Stock (the “December 2024 RDO Common Warrants” and together with the December 2024 RDO Pre-Funded Warrants and the warrants issued to StockBlock pursuant to certain contractual obligations between us and StockBlock (the “StockBlock Warrants”), the “December 2024 RDO Warrants”). The combined offering price (a) per share of Common Stock and accompanying December 2024 RDO Common Warrants was $20.65 and (b) per December 2024 RDO Pre-Funded Warrant and accompanying December 2024 RDO Common Warrants was $20.65. We received approximately $17.0 million in gross proceeds from the December 2024 RDO, before deducting offering fees and expenses. We intend to use the net proceeds from the December 2024 RDO for working capital and general corporate purposes, which may include capital expenditures, commercialization expenditures, research and development expenditures, regulatory affairs expenditures, clinical trial expenditures, acquisitions of new technologies and investments, business combinations and the repayment, refinancing, redemption or repurchase of indebtedness or capital stock.
Amendment to Common Stock Purchase Warrant
On December 11, 2024, we entered into a warrant amendment (the “Warrant Amendment”) with one of the investors to exercise the outstanding amount of certain warrants that we issued to such investor in the February 2024 BDO on March 5, 2024. Pursuant to the Warrant Amendment, the investor agreed to exercise outstanding warrants to purchase an aggregate of 1,764,706 shares of Common Stock in cash at an amended exercise price of $0.59 per share. The gross proceeds to us from such exercise was approximately $1.0 million.
Warrant Exchange Agreements
On July 22, 2025, the Company entered into Warrant Exchange Agreements (each, a “Warrant Exchange Agreement” and collectively, the “Warrant Exchange Agreements”) with certain holders of the Company’s then-existing Tranche B warrants (such certain holders (excluding Oramed), the “Exchanging Warrant Holders”) to purchase shares of Common Stock (such Tranche B warrants held by the Exchanging Warrant Holders, the “Existing Tranche B Warrants”). Pursuant to the Warrant Exchange Agreements, the Company and the Exchanging Warrant Holders effected a voluntary securities exchange whereby the Exchanging Warrant Holders exchanged the Existing Tranche B Warrants, which were then exercisable for an aggregate of 107,142 shares of Common Stock at an exercise price of $36.40 per share, originally issued pursuant to the Tranche B Securities Purchase Agreement, for warrants to purchase an aggregate of 500,000 shares of Common Stock (the “Exchange Warrants”) at an exercise price of $40.00 per share (the “Exchange Warrant Exercise Price”).
Warrant Exercise Agreement
On September 30, 2025, we entered into a Warrant Exercise Agreement (the “Warrant Exercise Agreement”) with certain holders of the December 2024 RDO Common Warrants, pursuant to which, among other things, such holders exercised the December 2024 RDO Common Warrants to purchase 179,236 shares and deferred, for a deferral fee of $7.72 per share being exercised, their right to receive an amortization payment scheduled to be paid by us on October 1, 2025, as set forth in the amortization schedule included in the Tranche B Notes in exchange for our agreement to issue new warrants to purchase an aggregate of 275,000 shares of Common Stock (the “September 2025 Warrants”) at an exercise price of $20.00 per share.
Warrant Inducement Agreement
On November 23, 2025, we entered into a warrant inducement agreement (the “Warrant Inducement Agreement”) with a certain institutional investor, pursuant to which the investor agreed to exercise (the “Exercise”) (i) a warrant to purchase shares of Common Stock issued to the investor on April 25, 2024, which was then exercisable for 428,572 shares and has an exercise price of $38.50 per share (the “Existing April 2024 Warrants”) and (ii) a warrant to purchase shares of Common Stock issued to the investor on December 13, 2024, which was then exercisable for 475,824 shares and has an exercise price of $22.72 per share (together with the Existing April 2024 Warrants, the “Existing Warrants”). As consideration for the Exercise, the Company agreed to (i) reduce the exercise price of the Existing Warrants to $22.51 per share and (ii) issue to the investor the “November 2025 Investor Warrant”) to purchase up to an aggregate of 1,356,594 shares of Common Stock with an exercise price of $29.00 per share (the “November 2025 Investor Warrant Exercise Price”) in a private placement pursuant to Section 4(a)(2) of the Securities Act. The November 2025 Investor Warrant shall be immediately exercisable and in certain circumstances may be exercised on a cashless basis. The November 2025 Investor Warrant shall expire five years from the date of its issuance. The November 2025 Investor Warrant Exercise Price shall be subject to adjustment for any stock split, stock dividend, stock combination, recapitalization or similar event. Further, in connection with a warrant inducement agreement and pursuant to the terms of an engagement agreement by and between the Company and StockBlock, dated as of March 22, 2024 (as amended and supplemented from time to time, the “Engagement Agreement”), the Company has agreed to issue the placement agents or their designees, warrants to purchase up to an aggregate of 72,352 shares of Common Stock (the “November 2025 Placement Agent Warrants” and, together with the November 2025 Investor Warrant, the “November 2025 Warrants”). The November 2025 Placement Agent Warrants have substantially the same terms of the November 2025 Warrant, including exercise price and expiration.
Future Liquidity Needs
We have based our anticipated operating capital requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. The amount and timing of our future funding requirements will depend on many factors, some of which are outside of our control, including but not limited to:
- the costs and expenses associated with our ongoing commercialization efforts for ZTlido, GLOPERBA and ELYXYB;
- the degree of success we experience in commercializing ZTlido, GLOPERBA and ELYXYB;
- the revenue generated by sales of ZTlido, GLOPERBA, ELYXYB and other products that may be approved, if any;
- the scope, progress, results and costs of conducting studies and clinical trials for our product candidates, SEMDEXA, SP-103 and SP-104;
- the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates;
- the costs of manufacturing ZTlido, GLOPERBA, ELYXYB and our product candidates;
- the timing and amount of any milestone, royalty or other payments we are required to make pursuant to any current or future collaboration or license agreements;
- our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;
- the extent to which ZTlido, GLOPERBA, ELYXYB or any of our product candidates, if approved for commercialization, is adopted by the physician community;
- our need to expand our research and development activities;
- the costs of acquiring, licensing or investing in businesses, product candidates and technologies;
- the effect of competing products and product candidates and other market developments;
- the number and types of future products we develop and commercialize;
- any product liability or other lawsuits related to our products;
- the expenses needed to attract, hire and retain skilled personnel;
- the costs associated with being a public company;
- our need to implement additional internal systems and infrastructure, including financial and reporting systems;
- the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;
- the costs related to servicing of our debt;
- the extent and scope of our general and administrative expenses; and
- our commitment to provide funding to third-parties
Should our sales of ZTlido, GLOPERBA, ELYXYB and other product candidates not materialize at the anticipated rate contemplated in our business plan, we will need to raise additional capital in order to continue to fund our research and development, including our plans for clinical and preclinical trials and new product development, as well as to fund operations generally. We will seek to raise additional funds through various potential sources, such as equity and debt financings and license agreements.
However, our ability to generate proceeds will depend on the market price of our Common Stock. In addition to the liquidity provided by revenue generating products, as of June 30, 2026, we would receive up to an aggregate of approximately $73.5 million from the exercise of the “Private Warrants” and public warrants to purchase Common Stock (the “Public Warrants,” and together with the Private Warrants, the “SPAC Warrants”) (at an exercise price of $397.89 per whole share of Common Stock), assuming the exercise in full of all of the SPAC Warrants for cash, but will not receive any proceeds from the sale of the shares of our Common Stock issuable upon such exercise. If the price of our Common Stock remains below $397.89 per share, we believe warrant holders will be unlikely to cash exercise their SPAC Warrants, resulting in little or no cash proceeds to us. To the extent any of the February 2024 BDO Firm Warrants, February 2024 BDO Representative Warrants, April 2024 RDO Placement Agent Warrants, Deposit Warrant, October 2024 Noteholder Warrants, October 2024 Placement Agent Warrants, December 2024 RDO Common Warrants, StockBlock Warrants, the Exchange Warrants, the September 2025 Warrants, the November 2025 Warrants and the February 2026 Warrants is exercised, we will receive additional proceeds.
We can give no assurances that we will be able to secure additional sources of funds to support our operations on acceptable terms, or at all, or, if such funds are available to us, that such additional financing will be sufficient to meet our needs. These conditions, among others, raise substantial doubt about our ability to continue as a going concern. If we raise additional funds by issuing equity or convertible debt securities or as we have done pursuant to the Oramed Note and the Tranche B Notes, it could result in dilution to our existing stockholders or increased fixed payment obligations. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders. If we incur additional indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term, but we may have to relinquish valuable rights to ZTlido, GLOPERBA, ELYXYB, or our product candidates or grant licenses on terms that are not favorable to us. Any of the foregoing could significantly harm our business, financial condition and results of operations. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to reduce the scope of the commercialization of ZTlido, GLOPERBA or ELYXYB or delay, scale back or discontinue the development of one or more of our product candidates.
We may also need to take certain other actions to allow us to maintain our projected cash and projected financial position including but not limited to, additional reductions in general and administrative costs, sales and marketing costs, suspension or winding down of clinical development programs for SP-102, SP-103 and SP-104 and other discretionary costs. Although we believe such plans, if executed and coupled with the above described sources of liquidity, should provide us with financing to meet our needs, successful completion of such plans is dependent on factors outside our control.
We anticipate that we will continue to incur net losses into the foreseeable future as we support our clinical development to expand approved indications, continue our development of, and seek regulatory approvals for, our product candidates, and expand our corporate infrastructure. As a result, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year after the date that the unaudited condensed consolidated financial statements are issued. See Note 2 titled “Liquidity and Going Concern” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information. Our existing cash and cash equivalents may be insufficient to enable us to fund our operating expenses, capital expenditure requirements, and to service our debt obligations (whether under the Oramed Note, the Tranche B Notes or otherwise) for at least the next 12 months. If these sources are insufficient to satisfy our liquidity requirements, we may seek to raise additional funds through equity offerings, debt financings, collaborations, government contracts or other strategic transactions.
Cash Flows
The following table summarizes our cash flows for each of the periods presented (in thousands):
| Cash Flow Data: | Six Months Ended June 30, 2026 | 2025 |
|---|---|---|
| Net cash (used for) proceeds from operating activities | $(7,844) | $13,057 |
| Net cash used for investing activities | (709) | (548) |
| Net cash provided by (used for) financing activities | 4,661 | (11,682) |
| Foreign currency translation adjustment | (497) | — |
| Net change in cash and cash equivalents | $(4,389) | $827 |
Cash Flows from Operating Activities
For the six months ended June 30, 2026, net cash used in operating activities was approximately $7.8 million, attributable to our net loss of $160.6 million, partially offset by the changes in operating assets and liabilities that provided $44.8 million of cash and other non-cash reconciling items of $108.0 million related to transaction costs expensed related to amortization of debt issuance costs and debt discount, non-cash interest expense for deferred consideration, stock-based compensation, loss on disposition of property and equipment, gain on derivative liability, loss on compound derivative of Scilex-St. James Loans, losses on sale of securities, change in fair value of debt and liability instruments, change in fair value of digital assets, contingent consideration, dividend payable and equity investments, depreciation and amortization and non-cash operating lease cost, non-cash revenue, allowances for expected credit losses and gain from property in kind dividend.
For the six months ended June 30, 2025, net cash proceeds from operating activities were approximately $13.1 million, attributable to the changes in operating assets and liabilities that provided $48.8 million of cash and other non-cash reconciling items of $34.4 million related to stock-based compensation, change in fair value of debt and liability instruments, financing costs, depreciation and amortization and non-cash operating lease cost and change on fair value of derivative liabilities, partially offset by our net loss of $70.1 million.
Cash Flows from Investing Activities
For the six months ended June 30, 2026, net cash used for investing activities was approximately $0.7 million and was related to the issuance of a convertible note receivable to QScan of $20.0 million, purchases of digital assets of $18.7 million, payments made for an intangible asset of $2.9 million, repayment of a promissory note of $1.4 million, payment made for the Datavault license of $6.3 million, purchase of preferred shares of Vivasor of $0.3 million, purchases of property and equipment of $0.6 million, $0.3 million related to payments of deferred consideration for the Romeg intangible asset acquisition under the Romeg License Agreement and a $0.5 million payment made for PA OPS Investment, partially offset net proceeds from the by sale of Datavault shares for cash of $47.3 million, net and the sale of marketable securities of $3.0 million.
For the six months ended June 30, 2025, net cash used for investing activities was approximately $0.5 million and was related to the $0.2 million purchase of Gloperba Ex-U.S. rights, in-process research and development assets and $0.3 million related to payments of deferred consideration for the Romeg intangible asset acquisition under the Romeg License Agreement.
Cash Flows from Financing Activities
For the six months ended June 30, 2026, net cash provided by financing activities was approximately $4.7 million and was primarily related to $15.5 million of proceeds from issuance of Tranche 3 of the Scilex-St. James Loans and $1.5 million for the issuance of shares to a third-party attributable to the non-controlling interest in Vivasor and $0.1 million related to proceeds from the issuance of Vivasor debt, partially offset by a $6.3 million repayment of borrowings under the Tranche B Notes, a $1.2 million payment under the ZTlido Royalty Purchase Agreement and Gloperba-Elyxyb Royalty Purchase Agreement, a $2.5 million repayment of borrowings under the Vivasor related debt and $2.4 million related to the repurchase of Vivasor preferred shares.
For the six months ended June 30, 2025, net cash used for financing activities was approximately $11.7 million and was primarily related to a $8.8 million repayment of borrowings under the Tranche B Notes, a $1.2 million payment under the ZTlido Royalty Purchase Agreement and Gloperba-Elyxyb Royalty Purchase Agreement, a $0.7 million payment of transaction costs in connection with the share repurchase, a $0.7 million payment of excise tax on the share repurchase and a $0.3 million payment of deferred transaction costs related to the Semnur Business Combination.
Critical Accounting Estimates
This management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial statements which are prepared in accordance with the accounting principles generally accepted in the United States (“U.S. GAAP”). The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses during the reporting period. We continually evaluate our estimates and judgments and base them on historical experience and other factors that we believe to be reasonable under the circumstances. Materially different results can occur as circumstances change, and additional information becomes known.
There have been no material changes in our critical accounting estimates as compared to the critical accounting estimates disclosed in the section titled “Management’s Discussion and Analysis of Financial Condition and Operations” included in the Annual Report on Form 10-K.
Recent Accounting Pronouncements
See Note 1 titled “Nature of Operations and Basis of Presentation” of the Notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for a discussion of recent accounting pronouncements.
Emerging Growth Company
An “emerging growth company” as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), is eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, changes in U.S. GAAP or their interpretation, the adoption of new guidance or the application of existing guidance to changes in Scilex’s business could significantly affect our business, financial condition and results of operations.
In addition, we are in the process of evaluating the benefits of relying on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an emerging growth company, we may take advantage of certain exemptions from various reporting requirements and other burdens that are otherwise applicable generally to public companies. These provisions include, but are not limited to:
- an exemption from compliance with the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”);
- an exemption from compliance with any new requirements adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation;
- reduced disclosure about our executive compensation arrangements in our periodic reports, proxy statements and registration statements; and
- exemptions from the requirements of holding non-binding advisory votes on executive compensation or golden parachute arrangements.
Scilex qualifies and will remain as an emerging growth company until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the closing of the IPO, (b) in which Scilex has a total annual gross revenue of at least $1.235 billion, or (c) in which Scilex is deemed to be a large accelerated filer, which means the market value of the common equity of Scilex that is held by non-affiliates equals or exceeds $700 million as of the last business day of its most recently completed second fiscal quarter; and (ii) the date on which Scilex has issued more than $1.00 billion in non-convertible debt securities during the prior three-year period. References herein to “emerging growth company” have the meaning associated with it in the JOBS Act.
Smaller Reporting Company
Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. Scilex qualifies and will remain a smaller reporting company until the last day of the fiscal year in which (i) Scilex has annual revenue of at least $100 million and a public float that equals or exceeds $700 million as of the last business day of its most recently completed second fiscal quarter or (ii) Scilex has a public float that equals or exceeds $250 million as of the last business day of its most recently completed second fiscal quarter.
Market risk
As filed, 179 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
There have been no material changes in our market risk during the six months ended June 30, 2026 compared to the disclosures in Part II, Item 7A of the Annual Report on Form 10-K.
Controls and procedures
As filed, 2,644 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the SEC’s regulations, rules and forms and that such information is accumulated and communicated to our management, including our principal officers, as appropriate, to allow for timely decisions regarding required disclosure.
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. As required by Rule 13a-15(b) promulgated by the SEC under the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on the foregoing, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Quarterly Report on Form 10-Q.
Inherent Limitations on Effectiveness of Controls
Because of its inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Accordingly, our controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our control system are met. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Risk factors
As filed, 40,518 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
Investing in our Common Stock involves a high degree of risk. Before making an investment decision, you should carefully consider the risks described herein, as well as the risks and uncertainties discussed above under “Cautionary Note Regarding Forward-Looking Statements”, before deciding whether to invest in our Common Stock. Our Annual Report on Form 10-K, in Part I–Item 1A, Risk Factors, describes important risk factors that could cause our business, financial condition, liquidity, results of operations and growth prospects to differ materially from those indicated or suggested by forward-looking statements made in this Quarterly Report on Form 10-Q or presented elsewhere by management from time to time. Except as set forth below, there have been no material changes in the risk factors that appear in Part I–Item 1A of our Annual Report on Form 10-K. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may become material and adversely affect our business.
Risks Related to our Limited Operating History, Financial Condition and Capital Requirements
We have a limited operating history and have incurred significant losses since our inception. We anticipate that we will incur continued losses for the foreseeable future.
We have a limited operating history. Prior to March 2019, our operations were conducted through Scilex Pharma, which was formed in September 2012 and is now our wholly owned subsidiary. In March 2019, we effected a corporate reorganization and acquired Semnur Pharmaceuticals, Inc., then a majority-owned subsidiary of our company (“Legacy Semnur”), which was formed in June 2013. Since our inception, we have focused on organizing and staffing our company, business planning, raising capital, identifying potential non-opioid pain therapy candidates, undertaking preclinical studies and clinical trials of our product candidates and establishing research and development and manufacturing collaborations. Most of our revenue to date is attributable to sales of ZTlido, and we expect that sales of ZTlido will account for most of our revenue for at least the near term. Our relatively short operating history as a company makes any assessment of our future success and viability subject to significant uncertainty.
Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. We will encounter risks and difficulties frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields, and we have not yet demonstrated an ability to overcome such risks and difficulties successfully. Our ability to execute on our business model and generate revenues depends on a number of factors including our ability to:
- successfully complete ongoing clinical trials and obtain regulatory approvals for our current and future product candidates;
- identify new acquisition or in-licensing opportunities;
- successfully identify new product candidates and advance those product candidates into pre-clinical studies and clinical trials;
- raise additional funds when needed and on terms acceptable to us;
- attract and retain experienced management and advisory teams;
- add operational, financial and management information systems and personnel, including personnel to support clinical, manufacturing and planned future commercialization efforts and operations;
- launch commercial sales of our product candidates, whether alone or in collaboration with others;
- initiate and continue relationships with third-party suppliers and manufacturers and have commercial quantities of product candidates manufactured at acceptable cost and quality levels and in compliance with the FDA, and other regulatory requirements;
- set acceptable prices for product candidates and obtain coverage and adequate reimbursement from third-party payors;
- achieve market acceptance of product candidates in the medical community and with third-party payors and consumers; and
- maintain, expand and protect our intellectual property portfolio.
If we cannot successfully execute any one of the foregoing, our business may not succeed or become profitable.
Since our inception, we have incurred significant net losses, with net losses of $374.0 million and $72.8 million for the years ended December 31, 2025 and 2024, respectively. For the six months ended June 30, 2026 and 2025, we had net losses of $160.6 million and $70.1 million, respectively. As of June 30, 2026 and December 31, 2025, we had an accumulated deficit of $1,078.6 million and $921.8 million, respectively. For the foreseeable future, we expect to continue to incur significant expenses related to the commercialization of ZTlido, GLOPERBA and ELYXYB and the research and development of our product candidates, SP-102 (10 mg dexamethasone sodium phosphate viscous gel) (“SEMDEXA”), SP-103 (lidocaine topical system) 5.4% (“SP-103”), and SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”). We anticipate that our expenses will increase substantially due to any future trials related to SEMDEXA and SP-103 and initiation of the Phase 2 clinical trial for SP-104. Consequently, we expect to incur substantial losses for the foreseeable future and may never become profitable.
We are subject to risks incidental to the development of new biopharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.
If we are unable to raise capital through a registered offering, we would be required to conduct our equity financing transactions on a private placement basis, which may be subject to pricing, size and other limitations imposed under the Nasdaq Listing Rules, or seek other sources of capital.
The terms of the Oramed Note and the Tranche B Notes impose certain operating and financial covenants that restrict our operating and financial flexibility and any failure to comply with such covenants could result in an event of default that could adversely affect our business, financial condition and results of operations.
On September 21, 2023 (the “Oramed Closing Date”), we issued and sold to Oramed the Oramed Note pursuant to that certain securities purchase agreement we entered into with Oramed, dated as of September 21, 2023 (the “Scilex-Oramed SPA”). Interest under the Oramed Note accrues at a fluctuating per annum interest rate equal to the sum of (1) the greater of (x) four percent (4%) and (y) Term SOFR (as defined in the Oramed Note) and (2) eight and one-half percent (8.5%), payable in-kind on a monthly basis.
Pursuant to the Oramed Note, since the outstanding principal of the Oramed Note was not repaid in full on or prior to March 21, 2024, an exit fee of $3,056,250 has been earned with respect to the Oramed Note, which shall be due and payable on the date the outstanding principal amount of the Oramed Note is paid in full. Upon the occurrence and during the continuance of an event of default under the Oramed Note, holders of more than 50% of the aggregate unpaid principal amount of the Oramed Notes may elect to cause all outstanding amounts under the Oramed Note to accrue interest at a default rate equal to the lesser of (i) Term SOFR plus fifteen percent (15%) or (ii) the maximum rate permitted under applicable law.
If the Oramed Note is accelerated upon an event of default, we are required to repay the principal amount of the Oramed Note at a mandatory default rate of 125% of such principal amount (together with 100% of accrued and unpaid interest thereon and all other amounts due in respect of the Oramed Note). The Oramed Note contains mandatory prepayment provisions requiring us and our subsidiaries to use 70% of the net cash proceeds of any Cash Sweep Financing (as defined in the Oramed Note) or advance under the ELOCs (as defined in the Oramed Note) to prepay the outstanding principal amount of the Oramed Note (the “Mandatory Prepayment Sweep”). Following each of the April 2024 RDO, the receipt of the FSF Deposit and sales of shares pursuant to that certain at-the-market sales agreement entered into on December 22, 2023, by and among the Company, B. Riley Securities, Inc., Cantor Fitzgerald & Co. and H.C. Wainwright & Co., LLC (the “ATM Sales Agreement”) (which agreement was voluntarily terminated by us effective as of March 5, 2025), that occurred in April 2024, June 2024, and January 2024, respectively, we made mandatory prepayments of $9.6 million, $7.0 million and $1.8 million, respectively, to Oramed, which equaled 70% of the net cash proceeds we received from each of the April 2024 RDO, the FSF Deposit and the sale of shares pursuant to the ATM Sales Agreement. Given such payment was not a voluntary prepayment, such prepayment did not trigger the make-whole amount under the Oramed Note.
On October 8, 2024 (the “Issuance Date”), we issued and sold in a registered offering to certain institutional investors (collectively, the “Tranche B Investors”) and Oramed (together with the Tranche B Investors, the “Tranche B Noteholders”) senior secured convertible notes in the aggregate principal amount of $50.0 million (the “Tranche B Notes”), which notes are convertible into shares of Common Stock, pursuant to the Tranche B Securities Purchase Agreement. In consideration for Tranche B Notes issued to Oramed, the outstanding principal balance of the Oramed Note was reduced by $22.5 million, and additional principal payments of an aggregate amount of $15.0 million were made in November and December 2024. As of June 30, 2026, the outstanding principal amount, as well as the accrued interest and fees, of the Oramed Note was $29.5 million, with the remaining amount due on March 21, 2025, which maturity date was extended to December 31, 2025 pursuant to an amendment letter we entered into with Oramed, dated as of January 21, 2025, and extended further to September 30, 2026, pursuant to an amendment letter we entered into with Oramed, dated as of June 25, 2026. In September 2025 and December 2025, the Company fully exercised its option to repurchase an aggregate of 6,500,000 warrants related to the issuance of the Oramed Note (the “Penny Warrants”) and paid to Oramed the $1.5 million consideration for such option (the “Option Payment Amount”) in full, extending the maturity date of the Oramed Note to March 31, 2026, and waiving any make-whole payment otherwise due thereunder upon prepayment. On March 29, 2026, the Company received notice from Oramed granting a one-time extension of certain payment obligations under existing debt arrangements. Pursuant to the extension, (i) the final payment due under Note A and (ii) the April 1, 2026, amortization payment due under the Tranche B Note were extended to April 20, 2026. On June 25, 2026, Oramed further extended the due dates of Note A and the April 1, 2026 and July 1, 2026 amortization payments due under the Tranche B Note to September 30, 2026. See Note 8 titled “Debt” to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for additional information.
Unless earlier converted or redeemed, the Tranche B Notes mature on the two-year anniversary of the Issuance Date, subject to extension at the option of the holder in certain circumstances as provided therein. The Tranche B Notes bear interest at a rate of 5.5% per annum, payable in arrears on the first trading day of each calendar quarter, beginning January 2, 2025, at our option, either in cash or in shares of Common Stock, subject to certain conditions. Pursuant to the amortization schedule included in the Tranche B Notes, an amortization payment that was scheduled to be paid to Oramed on October 1, 2025, was deferred until January 1, 2026, pursuant to the warrant agreement we entered into with Oramed on February 19, 2026, in exchange for the February 2026 Warrants (as defined in our Annual Report on Form 10-K). The deferred amortization payment was made to Oramed in November 2025.
The Oramed Note and the Tranche B Notes contain affirmative and negative covenants binding on us and our subsidiaries that restrict, among other things, us and our subsidiaries from incurring indebtedness or liens, repaying certain indebtedness, or declaring or paying any cash dividends or distributions, selling or otherwise disposing of any assets, and entering into transactions with affiliates, in each case as more fully set forth in, and subject to certain qualifications, exceptions, and “baskets” set forth in the Oramed Note and the Tranche B Notes. The Oramed Note also contains covenants requiring us to maintain a segregated bank account under specific terms and conditions, for purposes of receiving the Mandatory Prepayment Sweep, requiring SCLX JV, to comply with the separateness representations and covenants in its organizational documents, and requiring our subsidiary, SCLX DRE Holdings LLC, to maintain its status as a passive holding company. The Tranche B Notes also require us to, at the request of the holder, not more frequently than once per fiscal year, hire an independent, reputable investment bank to investigate whether any breach of the Tranche B Notes has occurred if an event constituting an event of default has occurred and is continuing or any holder reasonably believes that an event constituting an event of default has occurred or is continuing. In addition, the Tranche B Notes prohibit us from entering into specified fundamental transactions unless the successor entity assumes all of our obligations under the Tranche B Notes under a written agreement approved by the required holders of the Tranche B Notes before the transaction is completed. Upon consummation of specified fundamental transactions, the successor entity must confirm that upon conversion or redemption of the Tranche B Notes thereafter, shares of the successor entity will be issuable upon such conversion or redemption. The holders of the Tranche B Notes also have certain redemption rights upon a fundamental transaction constituting a change of control.
The Oramed Note and the Tranche B Notes contain certain customary events of default, including, without limitation, a cross-default to other specified indebtedness or any other indebtedness involving an obligation of a certain amount, a failure in payment of principal, as well as any bankruptcy, insolvency or reorganization event.
In addition, failure to comply with the covenants under the Oramed Note or Tranche B Notes could result in an event of default. The events of default under the Oramed Note include, among others, a change of control of our company and under the Tranche B Notes include, among others, any material adverse effect on our business, properties, assets, liabilities, operation, condition or prospects. Upon an event of default under the Oramed Note or the Tranche B Notes, subject to notice requirements in the case of certain events of default, all amounts outstanding under the Oramed Note may become immediately due and payable and the holders of the Tranche B Notes are entitled to certain conversion and redemption rights, respectively. We may not have sufficient funds or may be unable to arrange for additional financing to repay such indebtedness or to make any accelerated or redemption payments, and Oramed and/or the Tranche B Noteholders could seek to enforce their security interests in the collateral securing such indebtedness or other remedies available to them under the Oramed Note or Tranche B Notes, respectively, or as provided by applicable law. Oramed could also seek to enforce the guaranty under the Subsidiary Guarantee entered into by us and each of our subsidiaries, dated as of September 21, 2023, to carry out our payment obligations under the Oramed Note. Any failure by us to comply with the obligations under the Oramed Note or the Tranche B Notes could have a negative effect on our business, financial condition and results of operations.
Our outstanding indebtedness and any future indebtedness we may incur, combined with our other financial obligations, could increase our vulnerability to adverse changes in general economic, industry and market conditions, limit our flexibility in planning for, or reacting to, changes in our business and the industry and impose a competitive disadvantage compared to our competitors that have less debt or better debt servicing options. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
We will require substantial additional funding, which may not be available to us on acceptable terms, or at all.
Our operations have consumed substantial amounts of cash since inception. We expect to significantly increase our spending to continue our commercialization efforts for ZTlido, GLOPERBA and ELYXYB, advance development of our current product candidates and launch and commercialize any product candidates for which we receive regulatory approval. Furthermore, we expect to incur additional costs associated with operating as a public company. We will also require additional capital to fund our other operating expenses and capital expenditures.
As of June 30, 2026, our cash and cash equivalents were approximately $0.6 million and we had an accumulated deficit of $1,078.6 million. The amount and timing of our future funding requirements will depend on many factors, some of which are outside of our control, including but not limited to:
- the costs and expenses associated with our ongoing commercialization efforts for ZTlido, GLOPERBA and ELYXYB;
- the degree of success we experience in commercializing ZTlido, GLOPERBA and ELYXYB;
- the revenue generated by sales of ZTlido, GLOPERBA, ELYXYB and other products that may be approved, if any;
- the scope, progress, results and costs of conducting studies and clinical trials for our product candidates, SEMDEXA, SP-103 and SP-104;
- the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates;
- the costs of manufacturing ZTlido, GLOPERBA, ELYXYB and our product candidates;
- the timing and amount of any milestone, royalty or other payments we are required to make pursuant to any current or future collaboration or license agreements;
- our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;
- the extent to which ZTlido, GLOPERBA, ELYXYB or any of our product candidates, if approved for commercialization, is adopted by the physician community;
- our need to expand our research and development activities;
- the costs of acquiring, licensing or investing in businesses, product candidates and technologies;
- the effect of competing products and product candidates and other market developments;
- the number and types of future products we develop and commercialize;
- any product liability or other lawsuits related to our products;
- the expenses needed to attract, hire and retain skilled personnel;
- the costs associated with being a public company;
- our need to implement additional internal systems and infrastructure, including financial and reporting systems;
- the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;
- the costs related to servicing of our debt;
- the costs of financing additional clinical, regulatory and commercial activities; and
- the extent and scope of our general and administrative expenses.
Until we are able to generate significant revenue, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, government contracts or other strategic transactions. We cannot be sure that any additional funding, if needed, will be available on terms favorable to us, or at all. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Furthermore, any additional equity or equity-related financing may be dilutive to our stockholders, and debt or equity financing, if available, may subject us to restrictive covenants and significant interest costs. If we raise additional funds through collaborations or strategic alliances with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or technologies, or grant licenses on terms that may not be favorable to us. If we are unsuccessful in our efforts to raise additional financing on acceptable terms, we may be required to significantly reduce or cease our operations.
Our recurring losses from operations, negative cash flows and substantial cumulative net losses raise substantial doubt about our ability to continue as a going concern.
In Note 2 titled “Liquidity and Going Concern” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, we disclose that there is substantial doubt about our ability to continue as a going concern. We have negative working capital and have incurred significant operating losses and negative cash flows from operations and expect to continue incurring losses for the foreseeable future. Further, we had an accumulated deficit of $1,078.6 million as of June 30, 2026 and $921.8 million as of December 31, 2025. These conditions raise substantial doubt about our ability to continue as a going concern. Our unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Our ability to become a profitable operating company is dependent upon our ability to generate revenue and obtain financing adequate to fulfill our development and commercialization activities, and achieve a level of revenue adequate to support our cost structure. We have plans to obtain additional resources to fund our currently planned operations and expenditures through additional debt and equity financing. We will need to seek additional financing to fund our current operations, including the commercialization of ZTlido, GLOPERBA and ELYXYB, as well as the development of our other material product candidates for the next 12 months. Our plans are substantially dependent upon the success of future sales of ZTlido, GLOPERBA and ELYXYB, among which GLOPERBA and ELYXYB are still in the early stages of commercialization, and are dependent upon, among other things, the success of our marketing of ZTlido, GLOPERBA and ELYXYB and our ability to secure additional payor contracts with terms that are consistent with our business plan. If we are unable to obtain sufficient funding, our financial condition and results of operations will be materially and adversely affected and we may be unable to continue as a going concern. Future financial statements may disclose substantial doubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, or at all.
Risks Related to Ownership of our Common Stock
The market price of our Common Stock may fluctuate significantly, and investors in our Common Stock may lose all or a part of their investment.
The market prices for securities of biotechnology and pharmaceutical companies have historically been highly volatile, and the market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. For example, from November 11, 2022 (the first trading day following the closing of the Scilex Business Combination) to August 12, 2026, our closing stock price ranged from $2.48 to $322.54. The market price of our Common Stock may fluctuate significantly in response to numerous factors, some of which are beyond our control, such as:
- our ability to commercialize ZTlido, GLOPERBA, ELYXYB or our product candidates, if approved;
- legal disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for ZTlido, GLOPERBA, ELYXYB or our product candidates, government investigations and the results of any proceedings or lawsuits, including, but not limited to, patent or stockholder litigation;
- announcements of the introduction of new products by our company and our competitors;
- issuances of debt or equity securities;
- market conditions and trends in the pharmaceutical and biotechnology sectors;
- overall performance of the equity markets and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies;
- trading volume of our Common Stock;
- ineffectiveness of our internal controls; and
- other events or factors, many of which are beyond our control.
See the risk factor titled “If our operations and performance do not meet the expectations of investors or securities analysts, the market price of our securities may decline” in our Annual Report on Form 10-K for more factors affecting the trading price of our securities. The realization of any of the above risks or any of a broad range of other risks, including those described in these “Risk Factors,” could have a dramatic and material adverse impact on the market price of our Common Stock.
The equity markets in general have recently experienced extreme price and volume fluctuations. Continued market fluctuations could result in extreme volatility in the price of our Common Stock. Further, price volatility of our Common Stock might worsen if the trading volume of our Common Stock is low. Although we have had periods of high-volume daily trading in our Common Stock, generally our stock is thinly traded. As a consequence of this lack of liquidity, the trading of relatively small quantities of shares by our stockholders may disproportionately influence the price of those shares in either direction. If an active trading market for our Common Stock does not continue, the price of our Common Stock may be more volatile and it may be more difficult and time consuming to complete a transaction in our Common Stock, which could have an adverse effect on the realized price of our Common Stock. In addition, an adverse development in the market price for our Common Stock could negatively affect our ability to issue new equity to fund our activities.
Our Warrants are exercisable for our Common Stock, which would increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.
As of June 30, 2026, we have 6,958,204 outstanding SPAC Warrants, consisting of 5,958,204 Public Warrants and 1,000,000 Private Warrants (as defined below), which are currently exercisable for an aggregate of up to 198,807 shares of our Common Stock (on a post-Reverse Stock Split basis) in accordance with the terms of the Warrant Agreement (the “Warrant Agreement”), dated as of January 6, 2021, between Continental Stock Transfer & Trust Company, as warrant agent, and Vickers, governing those securities. The exercise price of these SPAC Warrants is $397.89 per whole share (on a post-Reverse Stock Split basis). “SPAC Warrants” means (i) the redeemable warrants that were included in the Units (each of which consisted of one Vickers ordinary share and one-half of one redeemable warrant) that, following the Scilex Business Combination and the Reverse Stock Split, entitle the holder of each whole warrant to purchase 1/35th of a share of Common Stock at a price of $397.89 per whole share (the “Public Warrants”), and (ii) the 6,840,000 warrants (which are currently exercisable for an aggregate of up to 195,429 shares of Common Stock, on a post-Reverse Stock Split basis) sold in a private placement to Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd consummated on January 11, 2021 (of which 2,736,000 (which are currently exercisable for an aggregate of up to 78,172 shares of Common Stock) were subsequently forfeited and 3,104,000 (which are currently exercisable for an aggregate of up to 88,686 shares of Common Stock, on a post-Reverse Stock Split basis) were transferred to Sorrento Therapeutics, Inc. (“Sorrento”), in each case in connection with the Scilex Business Combination) (the “Private Warrants”).
As of June 30, 2026, we have outstanding, (i) 3,803,447 February 2024 BDO Firm Warrants, which are currently exercisable for an aggregate of up to 108,686 shares of Common Stock, the exercise price of which is $59.50 per share; (ii) 470,588 February 2024 BDO Representative Warrants, which are currently exercisable for an aggregate of up to 13,446 shares of Common Stock, the exercise price of which is $74.38 per share; (iii) 3,250,000 Deposit Warrant, which is currently exercisable for an aggregate of up to 3,250,000 shares of Common Stock, the exercise price of which is $1.20 per share, and (iv) 1,200,000 April 2024 RDO Placement Agent Warrants, which are currently exercisable for an aggregate of up to 34,286 shares of Common Stock, the exercise price of which is $43.75 per share.
On October 8, 2024, we issued the October 2024 Noteholder Warrants to purchase an aggregate of 214,284 shares of Common Stock. On the same date, we also issued the October 2024 Placement Agent Warrants to purchase an aggregate of 107,142 shares of Common Stock, which became exercisable 180 days following the date of issuance.
The current exercise price of both the October 2024 Noteholder Warrants and the October 2024 Placement Agent Warrants is $36.40 per share. On July 22, 2025, we entered into the Warrant Exchange Agreements with the Tranche B Investors, pursuant to which the October 2024 Noteholder Warrants to purchase up to 107,142 shares of Common Stock were surrendered in exchange for the New Tranche B Warrants. Oramed waived its right to participate in the exchange.
On December 13, 2024, we issued the December 2024 RDO Pre-Funded Warrants (as defined below) to purchase an aggregate of 68,604 shares of Common Stock, which have been fully exercised as of the date of this Quarterly Report on Form 10-Q. On the same date, we also issued the December 2024 RDO Common Warrants (as defined below) to purchase an aggregate of 1,642,871 shares of Common Stock and the StockBlock Warrants (as defined below) to purchase an aggregate of 131,472 shares of Common Stock, which became exercisable 180 days following the date of issuance. The exercise price of both the December 2024 RDO Common Warrants and the StockBlock Warrants is $22.72 per share and $25.81 per share, respectively. On September 30, 2025, we entered into the Warrant Exercise Agreement with certain holders of the December 2024 RDO Common Warrants, pursuant to which, among other things, December 2024 RDO Common Warrants to purchase 179,236 shares were exercised and we issued such exercising holders new warrants (the “September 2025 Warrants”) to purchase an aggregate of 275,000 shares of Common Stock at an exercise price of $20.00 per share.
To the extent the SPAC Warrants, the Penny Warrants, the February 2024 BDO Firm Warrants, the February 2024 BDO Representative Warrants, the Deposit Warrant, the Fee Warrant (as defined in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on April 10, 2026), the April 2024 RDO Common Warrants, the April 2024 RDO Placement Agent Warrants, the October 2024 Noteholder Warrants, the October 2024 Placement Agent Warrants, the December 2024 RDO Common Warrants, the StockBlock Warrants, the New Tranche B Warrants and the September 2025 Warrants (collectively, the “Warrants”) are exercised, additional shares of our Common Stock will be issued, which will result in dilution to the holders of our Common Stock and increase the number of shares eligible for resale in the public market. Sales of substantial numbers of such shares in the public market, or the fact that such Warrants may be exercised, could adversely affect the prevailing market prices of our Common Stock. There is no guarantee that the Warrants will ever be in the money prior to their expiration, and as such, the Warrants may expire worthless. See below risk factor, “The SPAC Warrants may never be in the money, they may expire worthless and the terms of the SPAC Warrants may be amended in a manner adverse to a holder if holders of a majority of the then-outstanding SPAC Warrants approve of such amendment. In addition, almost all of the other warrants to purchase shares of our Common Stock are out-of-the-money and may also expire worthless.”
Risks Related to the Pending Transaction with Phoenix Asia Holdings Limited
As previously announced by the Company and as disclosed in the Notes to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, on May 4, 2026, ACEA Therapeutics, Inc. (“ACEA Therapeutics”), an indirect minority owned subsidiary of the Company, entered into a Stock Acquisition Agreement (the “ACEA-PHOE SAA”) with Phoenix Asia Holdings Limited, a company organized under the laws of the Cayman Islands (“Phoenix Asia”), and ACEA Pharma, Inc., a wholly owned subsidiary of ACEA Therapeutics and an exempted company incorporated with limited liability in the Cayman Islands (“ACEA Pharma”), pursuant to which ACEA Therapeutics agreed to transfer and sell, and Phoenix Asia agreed to purchase, 100% of the issued and outstanding shares of common stock of ACEA Pharma in exchange for the delivery to ACEA Therapeutics of 100,000,000 newly-issued ordinary shares at $10.00 per share, par value $0.00001 per share, of Phoenix Asia (the “PHOE Acquisition” and such shares, the “PHOE Shares”), the value of which was agreed by the parties to be $1.0 billion. Upon the closing of the PHOE Acquisition, the Company anticipates that ACEA Therapeutics will own approximately 82% of Phoenix Asia.
Failure to complete the PHOE Acquisition could negatively impact our business, financial condition, results of operations or stock prices.
The completion of the PHOE Acquisition is subject to a number of conditions and there can be no assurance that the conditions to the completion of the PHOE Acquisition will be satisfied. If the PHOE Acquisition is not completed, we will be subject to several risks, including:
- the current price of our common stock may reflect a market assumption that the PHOE Acquisition will occur and/or that the actual valuation of the PHOE Shares is $1.0 billion, meaning that a failure to complete the PHOE Acquisition could result in a decline in the price of our common stock;
- we would not realize any of the anticipated benefits of ACEA Therapeutics having completed the PHOE Acquisition; and
- under the ACEA-PHOE SAA, ACEA Pharma is subject to certain restrictions on the conduct of its business prior to completing the PHOE Acquisition, which restrictions could adversely affect its ability to realize certain of its business strategies.
If the PHOE Acquisition is not completed, these risks may materialize and materially and adversely affect our business, financial condition, results of operations or stock price.
Obtaining required approvals necessary to satisfy the conditions to the completion of the PHOE Acquisition may delay or prevent completion of the PHOE Acquisition.
The completion of the PHOE Acquisition is conditioned upon the receipt of certain governmental authorizations, consents, orders or other approvals. ACEA Therapeutics intends to pursue all required approvals in accordance with the ACEA-PHOE SAA, however, no assurance can be given that the required approvals will be obtained and, even if all such approvals are obtained, no assurance can be given as to the terms, conditions and timing of the approvals or that they will satisfy the terms of the ACEA-PHOE SAA. A failure to obtain such approvals may result in the PHOE Acquisition not being completed.
The agreed equity value of $1.0 billion set forth in the ACEA-PHOE SAA may not reflect the actual value of the equity consideration described therein.
The parties to the ACEA-PHOE SAA agreed to an equity value of $1.0 billion for the PHOE Shares to be issued to ACEA Therapeutics in the PHOE Acquisition. No assurance can be given that such value reflects the actual current or future value of such shares. If such valuation is not actually realized, it could have a material and adverse effect on our business, financial condition, results of operations or stock price.
We have entered into several term sheets and a letter of intent relating to proposed strategic transactions, but we may not execute definitive agreements with respect to one or more of such transactions, and any such transaction may not be completed on the terms contemplated by such term sheets or at all.
Since March 31, 2026, we have entered into several term sheets and a letter of intent relating to proposed strategic transactions, including a (i) binding term sheet with Datavault AI Inc. (“Datavault”), dated April 26, 2026, regarding a proposed $120.0 million cash contribution by us to Datavault and a revenue participation arrangement pursuant to which we would be entitled to a percentage of gross revenues recognized by Datavault attributable exclusively to Datavault’s Quantum-Edge Network, (ii) a binding term sheet with Datavault, dated June 24, 2026, regarding our proposed purchase of 837 Bitcoin from Datavault for an aggregate purchase price of $50.0 million to be paid by us in multiple tranches through December 31, 2028, (iii) a binding term sheet with iHolding Group LLP regarding a proposed $100.0 million investment in the Company through the purchase of approximately 6,666,667 newly issued shares of Common Stock at a purchase price of $15.00 per share, and (iv) a binding term sheet between our subsidiary Semnur Pharmaceuticals, Inc. (“Semnur”) and iHolding Group LLP regarding a proposed $100 million in Semnur through the purchase of newly issued common shares of Semnur at $10.00 per share, representing approximately 10,000,000 newly issued shares (the term sheets and letter of intent referenced in the preceding clauses (i) through (iv), collectively, the “Term Sheets” and the transactions contemplated thereby, the “Proposed Transactions”). See Notes 12 and 15 to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for more information regarding the Proposed Transactions.
The Term Sheets contemplate the execution of definitive agreements with respect to the applicable transactions, which are expected to include customary representations, warranties, covenants, indemnification provisions, and closing conditions for such transactions. The Proposed Transactions remain subject to further negotiation, regulatory and corporate approvals, market conditions, and other customary conditions outside the Company’s control. As of the date of this Quarterly Report on Form 10-Q, no definitive agreement for any of the Proposed Transactions has been entered into and there can be no assurance that definitive agreements for such transactions will be executed or that the Proposed Transactions will be consummated on the terms set forth in the applicable Term Sheet or at all.
Figures reported in this filing
Standardized line items from the XBRL in this filing, for the period ended 2026-06-30. Comparative periods it repeats are left out.
| Line item | Period | Value | XBRL concept |
|---|---|---|---|
| Revenue | 3 months2026-04-01 to 2026-06-30 | $7.6m | us-gaap:Revenues |
| Revenue | 6 months2026-01-01 to 2026-06-30 | $16.3m | us-gaap:Revenues |
| Cost of revenue | 3 months2026-04-01 to 2026-06-30 | $3.7m | us-gaap:CostOfRevenue |
| Cost of revenue | 6 months2026-01-01 to 2026-06-30 | $8.1m | us-gaap:CostOfRevenue |
| Gross profit | 3 months2026-04-01 to 2026-06-30 | $15.8m | us-gaap:GrossProfit |
| Gross profit | 6 months2026-01-01 to 2026-06-30 | $41.5m | us-gaap:GrossProfit |
| Research and development | 3 months2026-04-01 to 2026-06-30 | $3.3m | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 6 months2026-01-01 to 2026-06-30 | $6.5m | us-gaap:ResearchAndDevelopmentExpense |
| Selling, general and administrative | 3 months2026-04-01 to 2026-06-30 | $28.0m | us-gaap:SellingGeneralAndAdministrativeExpense |
| Selling, general and administrative | 6 months2026-01-01 to 2026-06-30 | $59.0m | us-gaap:SellingGeneralAndAdministrativeExpense |
| Operating income | 3 months2026-04-01 to 2026-06-30 | −$29.4m | us-gaap:OperatingIncomeLoss |
| Operating income | 6 months2026-01-01 to 2026-06-30 | −$61.6m | us-gaap:OperatingIncomeLoss |
| Interest expense | 3 months2026-04-01 to 2026-06-30 | $6.1m | us-gaap:InterestExpenseNonoperating |
| Interest expense | 6 months2026-01-01 to 2026-06-30 | $11.6m | us-gaap:InterestExpenseNonoperating |
| Income tax | 3 months2026-04-01 to 2026-06-30 | $7.0k | us-gaap:IncomeTaxExpenseBenefit |
| Income tax | 6 months2026-01-01 to 2026-06-30 | $7.0k | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months2026-04-01 to 2026-06-30 | −$115.0m | us-gaap:NetIncomeLoss |
| Net income | 6 months2026-01-01 to 2026-06-30 | −$160.6m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months2026-04-01 to 2026-06-30 | −$16.65 | us-gaap:EarningsPerShareDiluted |
| Diluted EPS | 6 months2026-01-01 to 2026-06-30 | −$22.93 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months2026-04-01 to 2026-06-30 | −$16.65 | us-gaap:EarningsPerShareBasic |
| Basic EPS | 6 months2026-01-01 to 2026-06-30 | −$22.93 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months2026-04-01 to 2026-06-30 | 6,892,000 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Diluted shares (weighted) | 6 months2026-01-01 to 2026-06-30 | 6,891,000 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 6 months2026-01-01 to 2026-06-30 | −$7.8m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 6 months2026-01-01 to 2026-06-30 | $593.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Cash and equivalents | At period end2026-06-30 | $566.0k | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | At period end2026-06-30 | $36.2m | us-gaap:AssetsCurrent |
| Total assets | At period end2026-06-30 | $253.6m | us-gaap:Assets |
| Current liabilities | At period end2026-06-30 | $512.2m | us-gaap:LiabilitiesCurrent |
| Total liabilities | At period end2026-06-30 | $564.0m | us-gaap:Liabilities |
| Current portion of debt | At period end2026-06-30 | $80.8m | us-gaap:DebtCurrent |
| Shareholders' equity | At period end2026-06-30 | −$308.3m | us-gaap:StockholdersEquity |
Source: SEC EDGAR, the filing index for accession 0001193125-26-352464. Last ingested by Listed: Oct 24, 2026, 15:15 ET. Listed shows no prices and gives no investment advice.