Climate Change Data

Environmental Metrics

Climate Goals & Targets

Environmental Challenges

• Significant operating losses since inception.
• Restatement of certain financial statements.
• Material weakness in internal control over financial reporting.
• Need to raise additional capital.
• Limited number of authorized shares.
• Substantial doubt about ability to continue as a going concern.
• Denied BARDA funding.
• Limited vaccine-specific experience.
• Limited financial resources.
• Vaccine product candidate in pre-clinical stage.
• Intense competition.
• Uncertainty regarding market opportunities for vaccine.
• Challenges in developing and commercializing product candidates.
• Potential need for significant resources for scale-up and development of vaccine.
• Significant competition for product candidates.
• Dependence on new and rapidly evolving technologies.
• Potential competition from biosimilars.
• Challenges in producing MU1140 homologs in large-scale quantities.
• Challenges in obtaining regulatory approval and commercializing lantibiotics.
• Potential to discontinue development or commercialization of product candidates.
• Limited experience in conducting clinical trials.
• Uncertainty regarding market and consumer acceptance of products.
• Challenges in obtaining marketing approval in international jurisdictions.
• Challenges in managing organizational growth.
• Potential for manufacturers and suppliers to fail to meet requirements.
• Dependence on key personnel.
• Need to hire and retain additional qualified personnel.
• Potential for product candidates to be ineffective or harmful.
• Need to identify vaccines for development and establish third-party relationships.
• Need to secure licensing partners to fund costs.
• Potential challenges in acquiring, investing in, or integrating businesses.
• Product liability exposure.
• Potential adverse effects from natural disasters, pandemics, and other catastrophic events.
• Limitations on use of net operating loss carryforwards and tax attributes.
• Substantial doubt about ability to continue as a going concern.
• Dependence on intellectual property and biological materials licenses.
• Additional expenses and obligations related to licenses.
• Uncertainty regarding patent applications.
• Potential for competitors to license same intellectual property.
• Potential for claims challenging patent inventorship.
• Potential for changes in patent law to diminish patent value.
• Potential for inability to protect intellectual property from infringement.
• Potential for inability to protect intellectual property rights worldwide.
• Potential for loss of license rights due to non-compliance.
• Potential for lawsuits for intellectual property infringement.
• Potential for lawsuits to protect or enforce patents.
• Potential for inadequate intellectual property protection.
• Potential for cybersecurity and information systems risks.
• Potential for security breaches and data compromise.
• Potential for costs associated with cybersecurity incidents.
• Potential for failures in internal computer systems.
• Substantial government regulation.
• Potential for inability to obtain regulatory approval.
• Potential for delays or difficulties in patient enrollment in clinical trials.
• Ongoing regulatory review and compliance obligations.
• Potential for serious or undesirable side effects.
• Potential for off-label promotion.
• Healthcare laws, regulations, and enforcement.
• Potential for misconduct by employees and third parties.
• Potential for inadequate adoption of product candidates by healthcare payers, physicians, and patients.
• Potential for inadequate coverage and reimbursement for product candidates.
• Potential for limited market acceptance due to unfavorable reimbursement or restrictive legislation.
• Adverse effects from public health crises.
• Impact of COVID-19 on clinical trials.
• Global and local risks related to COVID-19.
• Macroeconomic pressures.
• Economic uncertainty.
• Inadequate funding for government agencies.
• Dilution from issuance of additional equity securities.
• Potential delisting from NYSE American.
• Significant variability in financial results.
• Seniority of preferred stock.
• Dilution from conversion of preferred stock and exercise of warrants.
• Provisions preventing favorable change of control.
• Stock price volatility.
• Securities litigation.
• Depressed stock price from sales or issuances of common stock.
• Resource strain from being a public company.
• Negative analyst reports.
• Issuance of debt securities.
• Reduced disclosure and governance requirements as a smaller reporting company.
• Lack of dividend payments.
• Potential for failure to meet contractual obligations and regulatory requirements.
• Dependence on key personnel.
• Need to hire and retain additional qualified personnel.
• Potential for product candidates to be ineffective or harmful.
• Challenges in establishing successful third-party relationships.
• Challenges in securing licensing partners.
• Potential challenges in acquiring, investing in, or integrating businesses.
• Product liability exposure.
• Potential adverse effects from natural disasters, pandemics, and other catastrophic events.
• Limitations on use of net operating loss carryforwards and tax attributes.
• Substantial doubt about ability to continue as a going concern.

Mitigation Strategies

• Evaluating cost-saving initiatives and restructuring.
• Pursuing additional sources of financing.
• Implementing remedial measures to address material weakness in internal control.
• Seeking licensing partners to share costs.
• Implementing business continuity and disaster recovery plans.
• Continuing to pursue government grants and funding.
• Strengthening cybersecurity defenses.
• Maintaining compliance with regulatory requirements.

Supply Chain Management

Climate-Related Risks & Opportunities