Risk Factors Update Summary

• Increased reliance on CMOs for manufacturing may lead to supply disruptions, affecting clinical development and operations.
• Entered into a registration rights agreement with December 2023 Investors on December 7, 2023.
• Added risks related to financial condition and capital requirements, including inability to continue as a going concern. This change might result in significant financial impact.
• Increased uncertainty in intellectual property landscape may lead to costly legal expenses and potential product abandonment.
• Commencing clinical trials in the United States may be delayed due to additional preclinical studies.
• Added unfavorable pricing. This might lead to delays and harm business development activities.
• Addition of new product candidates SPY001 and SPY002 for limited indications may impact revenue.
• Added risks related to discovery, development, and commercialization, highlighting competition, program failures, and regulatory challenges.
• Changes in patent laws, like the Leahy-Smith Act, could impact patent prosecution and validity.
• Added the need to seek approval for ongoing clinical trials. This could delay marketing approvals.
• Failure to control manufacturing process or comply with regulatory requirements could result in significant additional costs.
• Agreed to make pro rata payments to investors if Registration Statement not declared effective.
• Potential competition from Erytech Pharma SA's product candidate for Homocystinuria in preclinical development.
• The company is substantially dependent on the success of SPY001 and SPY002 programs.
• Added risks related to government regulation, including lengthy approval processes and pricing regulations, impacting revenue.
• Added reliance on third parties for commercialization. This increases the risk of supply constraints.
• Expect to need significant additional capital for operations, leading to potential dilution.
• Geopolitical instability may impact patent protection in foreign countries, affecting competitive position.
• Acquisition of businesses or products may not realize expected benefits, leading to material adverse effects.
• Failure to develop complementary diagnostics could impact the commercial success of product candidates.
• Regulatory approval challenges may delay commercialization and revenue generation for product candidates.
• Risks associated with third-party patents, inventorship disputes, and ownership challenges could harm business.
• Principal stockholders have significant control over matters requiring stockholder approval.
• Delays in patient enrollment may significantly affect the completion of clinical trials.
• Risk of biosimilar competition sooner than anticipated due to regulatory exclusivity provisions.
• Added potential legal uncertainty due to Brexit. This may disrupt operations and increase costs.
• Failure to comply with environmental laws may result in fines or penalties impacting business success.
• Potential tax law changes could negatively impact financial condition and effective tax rate.
• Added the importance of protecting intellectual property rights. Failure could harm competitive advantage.
• Reliance on collaborations and licensing arrangements may lead to increased costs and disruptions.
• Increased regulatory scrutiny may lead to penalties, delays, and additional expenses in product development.
• Market price volatility due to factors like regulatory approvals, commercial success, and financial projections.
• Preliminary data from clinical trials may change as more participant data become available.
• The company may encounter delays in the development and commercialization of product candidates due to regulatory constraints.
• Failure to comply with GCP regulations may result in unreliable clinical data and additional trials.
• Added the risk of failing to obtain necessary rights to third-party intellectual property. This could lead to program abandonment.
• Provisions in corporate documents and Delaware law may make acquisition of the company more difficult.
• Market price influenced by geopolitical instability, sales of common stock, and financial results fluctuations.
• Potential limitations on product candidates due to regulatory requirements and safety concerns.
• Uncertainty in market acceptance and commercial success of product candidates due to regulatory complexities.
• Incur significant legal, accounting, and other expenses associated with public company requirements.
• Stockholders may not approve the conversion of Series B Preferred Stock, leading to potential cash settlement.
• Reliance on third parties for manufacturing may pose risks if production difficulties arise.
• The success of the company's programs heavily relies on the successful development of complementary diagnostics.
• Added the possibility of disputes with licensors over intellectual property rights. This may lead to significant costs and liabilities.