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You should carefully review and consider the information regarding certain factors that could materially affect our business, financial condition or future results set forth under Item 1A. Risk Factors in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 as filed with the SEC on March 4, 2026.
Ø We will require additional financing to execute our operating plan, and there is substantial doubt about our ability to continue as a going concern.
As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), we have the responsibility to evaluate whether conditions and/or events raise substantial doubt about our ability to meet our future financial obligations as they become due within one year after the date the condensed consolidated financial statements are issued. We have incurred historical losses from operations and anticipate that operating losses may continue for the foreseeable future as we continue to incur operating costs to execute our strategic plan, including costs related to the commercialization of AVMAPKI FAKZYNJA CO-PACK and the research and development of our product candidates. Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern within one year after the issuance date of our condensed consolidated financial statements.
To address these conditions, we expect to finance our operations with our existing cash, cash equivalents and investments and through one or more potential sources of additional liquidity, including sufficient future net product revenues, potential future milestones and royalties received pursuant to the Secura APA, funding pursuant to our Note Purchase Agreement or other strategic financing opportunities that could include, but are not limited to, collaboration agreements, offerings of our equity or the incurrence of debt. However, given the risks associated with these potential strategic or financing opportunities, they are not deemed probable for purposes of the going concern
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assessment and do not alleviate the substantial doubt about our ability to continue as a going concern. There can be no assurance that we will be able to generate sufficient net product revenues or obtain additional capital on favorable terms or at all.
If we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate our commercial efforts for AVMAPKI FAKZYNJA CO-PACK or our other research and development activities for our product candidates, or ultimately not be able to continue as a going concern.
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