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Item 1A. Risk Factors.
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.
| We will require additional financing to execute our operating plan, and |
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 believe that we may hahave sufficient funds to meet its obligations within the next 12 months from the issuance of these financial statements. However, this belief relies on the achievement of certain mitigation efforts. The analysis under ASC 205-40, initially cannot take into considincurred historical losses from operations and anticipate that operation the potential mitigang losses may conting effects of plans that have not beenue for the foreseeable fully implementedture as of the date the financial statements are issued. Additionally, we have had historical losses fromwe continue to incur operations and anticipang costs to execute that we may continue to our strategic plan, incur losses as we continueluding costs related to the commercialization of AVMAPKI FAKZYNJA CO-PACK and the research and development of our product candidates. Accordingly, these uncertainties and risk factors meetwe have concluded the ASC 205-40 standard for raising sat substantial doubt exists about our ability to continue as a going concern within one year ofafter the issuance date of our condensed consolidated financial statements. Lack of necessary funds may require us, among other things, to delay, scale back, or eliminate som
To address these conditions, we expect to finance our operations with our existing cash, cash equivalents and investments and through one or all of our planned clinical trials. Because we contimore potential sources of additional liquidity, including sufficient future net product revenue to experience net operating losss, potential future milestones and royalties (NOL), our abilityreceived pursuant to continue as a gothe Secura APA, funding concern is subjecpursuant to our ability to obtain necessary capital from outside sources,Note Purchase Agreement or other strategic financing opportunities that could including increasing our net product revenuee, but are not limited to, collaboration agreements, obtaining additional capital fromfferings of our equity or the saleincurrence of our securities ordebt. However, given the risks assets, achieving milestones fociated with these potential strategic or additional drawdowns under our Note Purchfinancing opportunities, they are not deemed probable for purposes of the going concern
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ase Agreesessment or obtain loans from financand do not alleviate the substantial institutions, or entering into additional partnership arrangementsdoubt about our ability to continue as a going concern. There can be no assurances that we will be able to ogenerate sufficient net product revenues or obtain suchadditional 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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