Climate Change Data

Environmental Metrics

Social Achievements

• Partnerships with World Leading Oncology Research Organizations and Major Pharmaceutical Companies (Merck and Bristol Myers Squibb)

Climate Goals & Targets

Environmental Challenges

• We are a clinical-stage biotechnology company with a limited operating history and have not generated any revenue to date from product sales.
• We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future.
• The report of our independent registered public accounting firm for the year ended December 31, 2021 contains a statement with respect to substantial doubt as to our ability to continue as a going concern as a result of recurring losses from operations and negative cash flows.
• We are largely dependent upon the success of our new intratumoral technology, which requires additional development and may never receive regulatory approval or be successfully commercialized.
• We have not completed clinical trials on any forms of cancer.
• Our prospects for obtaining additional financing are uncertain.
• The COVID-19 pandemic may affect our ability to initiate and complete current or future preclinical studies or clinical trials, disrupt regulatory activities or have other adverse effects on our business and operations.
• We have yet to obtain regulatory approval from the FDA, and therefore we are not currently permitted to market products made using our technology in the United States.
• Delays in FDA approval could be costly to us and prevent us from commercializing our product candidates effectively.
• Even if product candidates using our technology obtain approval, we will be subject to additional ongoing regulatory obligations and oversight.
• The FDA approval process is long, expensive and uncertain.
• Our ability to market a product may be limited by the uses that are approved for that product.
• We may be unable to export or sell products in foreign markets, which will limit our sales opportunities.
• We will rely on third parties to conduct preclinical research and any clinical trials.
• Third-party payors may not reimburse for the use of our product candidates or such reimbursement may be inadequate.
• We are dependent on third parties to manufacture components of the final drug products made using our technology.
• We purchase components for our product candidates from third parties, some of which may be sole-source suppliers.
• We have not entered into long-term manufacturing and supply agreements with any producers.
• We have limited experience and may not be successful in commercializing products that use the Technology.
• Our plan to use collaborative arrangements with third parties to help finance and to market and sell products using our technology may not be successful.
• We will be dependent on healthcare professionals’ efforts to learn about our product candidates.
• We may need to establish clinical training and centers of excellence to educate and train physicians and healthcare payors, but the key opinion thought leadership required for initial market acceptance within the healthcare arena may take time to develop.
• Rapid technological developments in treatment methods for cancer and competition with other forms of cancer treatments could affect our ability to achieve meaningful revenues or profit.
• Our success depends in part on our ability to obtain patents, maintain trade secret protection, operate without infringing on the proprietary rights of third parties, and commercialize our technology prior to the expiration of our patent protection.
• We may be unable to protect our intellectual property rights because of our limited resources.
• We may be the subject of product liability claims or product recalls.

Mitigation Strategies

• We intend to use the net proceeds from this offering to fund discovery and clinical development efforts as well as to further expand our manufacturing platform and capabilities, to grow our infrastructure to support our pipeline, and to fund new and ongoing research activities, working capital and other general corporate purposes, which may include funding for the hiring of additional personnel, capital expenditures and the costs of operating as a public company.

Supply Chain Management

Climate-Related Risks & Opportunities

Environmental Metrics

Social Achievements

• Maintained a flexible work from home arrangement, leaving it to employees to determine a schedule that best fits their individual needs.
• Created spaces that foster social engagement and sponsor reoccurring onsite events.
• Promote dialogue to ensure that employees feel supported.
• Advise employees to regularly take PTO, facilitate workshops promoting personal well-being, provide extensive subsidized health benefits, including access to mental health resources, and provide for gym reimbursement.
• Maintains pay equity in the U.S. for women and men and people of all races for employees performing similar work.

Climate Goals & Targets

Environmental Challenges

• Recurring losses from operations and negative cash flows.
• Lack of segregation of duties due to limited administrative staff.
• Limited reconciliation and review procedures over clinical contract accruals.
• Information technology matters regarding user access.
• Limited experience conducting cancer clinical trials.
• Intense competition from other biotechnology and pharmaceutical companies.
• Potential unauthorized disclosure or misappropriation of intellectual property by CROs.
• Third-party payors may not reimburse for the use of product candidates or such reimbursement may be inadequate.
• Limited experience in marketing and commercializing products.

Mitigation Strategies

• Hired a consultant with Danforth Advisors LLC as interim Chief Financial Officer.
• Hired a full-time CFO to add an additional layer of segregation of duties within accounting and payment processing procedures.
• Implementing additional controls over segregation of duties, reconciliation and review procedures, and information technology access controls.
• Reassessing accounting procedures and implementing supplementary checks and additional reviews and evaluations of transactions.
• Adding appropriate resources to ensure that such procedures are implemented and adequate reviews are performed.
• Engaging additional technical accounting consultants to provide additional resources for the preparation and review of quarterly close procedures.
• Evaluating new accounting software systems to improve system controls and implementing a new financial reporting and filing software platform.
• Intending to conduct clinical trials for sarcoma and breast cancer indications.
• Developing a sales, marketing, and distribution infrastructure and/or entering into strategic alliances.

Supply Chain Management

Climate-Related Risks & Opportunities