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Financial report summary
?Competition
Eisai • Pfizer • EOM Pharmaceutical • Roche Holding • Roche • Agenus • Alaunos Therapeutics • Stemline Therapeutics • ImmunityBio • Cellular BiomedicineRisks
- We will need to raise substantial funds, on an ongoing basis, for general corporate purposes and operations, including our clinical trials. Such funding may not be available or may not be available on acceptable terms.
- We are likely to continue to incur substantial losses and may never achieve profitability.
- Our auditors have issued a “going concern” audit opinion.
- Maintaining a strong control environment, free of material weaknesses, is dependent on our ability to retain an adequate number of qualified personnel and/or consultants to perform such control activities and other factors. Our management and our independent auditors have identified one material weakness for the year ended December 31, 2023.
- As a company with a novel technology and unproven business strategy, an evaluation of our business and prospects is difficult.
- We will need to expand our management and technical personnel as our operations progress, and we may not be able to recruit such additional personnel and/or retain existing personnel.
- We rely at present on third-party contract manufacturers. As a result, we may be at risk for issues with manufacturing agreements, capacity limitations and/or supply disruptions, and/or issues with product equivalency.
- The manufacturing of our product candidates will have to be greatly scaled up for commercialization, and neither we nor our contract manufacturers have experience with such scale-up.
- The necessary specialized facilities, equipment and personnel may not be available or obtainable for the scale-up of manufacturing of our product candidates.
- Our technology is novel, involves complex immune system elements, and may not prove to be effective.
- Clinical trials for our product candidates are expensive and time consuming, and their outcome is uncertain.
- We have limited experience in conducting and managing clinical trials, or collecting, confirming and analyzing trial data, and we rely on third parties to conduct these activities.
- We may fail to comply with regulatory requirements.
- Regulatory approval of our product candidates may be withdrawn at any time.
- Our operations under early access programs may not be successful.
- We may not be successful in negotiating reimbursement.
- Our product candidates will require a different distribution model than conventional therapeutic products, and this may impede commercialization of our product candidates.
- Our product candidates will require different marketing and sales methods and personnel than conventional therapeutic products. Also, we lack sales and marketing experience. These factors may result in significant difficulties in commercializing our product candidates.
- The availability and amount of potential reimbursement for our product candidates by government and private payers is uncertain and may be delayed and/or inadequate.
- Competition in the biotechnology and biopharmaceutical industry is intense, rapidly expanding and most of our competitors have substantially greater resources than we do.
- Competing generic medicinal products may be approved.
- We may be exposed to potential product liability claims, and our existing insurance may not cover these claims, in whole or in part. In addition, insurance against such claims may not be available to us on reasonable terms in the future, if at all.
- We may be subject to environmental regulatory requirements, and could fail to meet such requirements, and we do not carry insurance against environmental damage or injury claims.
- Collaborations play an important role in our business and could be vulnerable to competition or termination.
- Our business could be adversely affected by new legislation and/or product related issues.
- Our business could be adversely affected by animal rights activists.
- Multiple late-stage clinical trials of DCVax-L for GBM, our lead product, may be required before we can obtain regulatory approval.
- We may not receive regulatory approvals for our product candidates or there may be a delay in obtaining such approvals.
- We may not obtain or maintain the benefits associated with orphan drug status, including market exclusivity.
- Our intellectual property rights may be overturned, narrowed or blocked, and may not provide sufficient commercial protection for our product candidates, or third parties may infringe upon our intellectual property.
- We may be exposed to claims or lawsuits that our products infringe patents or other proprietary rights of other parties.
- DCVax is our only technology in clinical development.
- The market price of our common stock is volatile and can be adversely affected by several factors.
- Our Common Stock is considered a “penny stock” and may be difficult to sell.
- The requirements of the Sarbanes-Oxley Act of 2002 and other U.S. securities laws impose substantial costs and may drain our resources and distract our management.
- We do not intend to pay any cash dividends in the foreseeable future and, therefore, any return on your investment in our common stock must come from increases in the market price of our common stock.
- Our certificate of incorporation and bylaws and Delaware law, have provisions that could discourage, delay or prevent a change in control.
- A substantial number of shares of common stock may be sold in the market, which may depress the market price for our common stock.
- We may have claims and lawsuits against us that may result in adverse outcomes.
Management Discussion
- ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
- We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer. Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. Our additional product, DCVax®-Direct, is designed to treat inoperable solid tumors.
- During 2023, we completed or made substantial progress on all of the key areas that we outlined at the Annual Meeting in December 2022 as priorities for the following 12-18 months, as well as some additional areas not outlined at the Annual Meeting.