Company: SCLXW
Filing Date: 2025-01-17
Form Type: 10-Q
Source: 0000950170-25-006755
Chunk: 352

Company: Scilex Holding Co
Filing Date: 2025-01-17
Form: 10-Q
Item: Item 8
Chunk 352
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 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 $114.3 million, $23.4 million and $88.4 million for the years ended December 31, 2023, 2022 and 2021, respectively. For the nine months ended September 30, 2024 and 2023, we had net losses of $66.3 million and $92.9 million, respectively. As of September 30, 2024 and December 31, 2023, we had an accumulated deficit of approximately $556.6 million and $490.2 million, respectively. For the foreseeable future, we expect