CLBS Caladrius Biosciences, Inc.

Risks

• We have incurred substantial losses and negative cash flow from operations in the past and expect to continue to incur losses and negative cash flow for the foreseeable future.
• We anticipate that we will need substantial additional financing to continue our operations; if we are unable to raise additional capital, we may be forced to delay, reduce or eliminate one or more of our product development programs, and our business will be harmed.
• We have never generated any revenue from product sales and our ability to generate revenue from product sales and become profitable depends significantly on our success in a number of factors.
• If our status as a smaller reporting company changes, Section 404(b) of the Sarbanes-Oxley Act of 2002 may require an independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting. Any delays or difficulty in satisfying these requirements could adversely affect our future results of operations and our stock price.
• Our future success may be dependent on the timely and successful continued development and commercialization of CLBS03, our T1D product candidate for which we announced the failure of the Phase 2a trial to meet its primary endpoint, and if we encounter delays or further difficulties in the development of this product candidate, as well as CLBS12, our experimental product candidate for CLI that is in clinical development in Japan, or CLBS14 for CMD and NORDA, our business prospects would be significantly harmed.
• Even if we are able to successfully complete our clinical development programs for our product candidates and receive regulatory approval to market one or more of the products, if the commercial opportunities are smaller than we anticipate, our future revenues may be adversely affected, and our business may suffer.
• We may experience delays in enrolling patients in our clinical trials, which could delay or prevent the receipt of necessary regulatory approvals.
• We may have other delays in completing our clinical trials and we may not complete them at all.
• We may be unable to manage multiple late stage clinical trials for a variety of product candidates simultaneously.
• The development of our cell therapy product candidates are subject to uncertainty because autologous cell therapy is inherently variable.
• Any disruption to our access to the reagents we are using in the clinical development of our cell therapy product candidates could adversely affect our ability to perform clinical trials and seek future regulatory submissions.
• The initiation of pivotal Phase 3 clinical trials for cell therapy product candidates requires the validation and establishment of manufacturing controls that may delay product development timelines.
• Product candidates that appear promising in research and development may be delayed or may fail to reach later stages of clinical development.
• If serious or unacceptable side effects are identified during the development of any of our product candidate, we may need to abandon or limit our development of that product candidate.
• A Fast Track designation by the FDA and other similar regulatory designations may not lead to a faster development, regulatory review or approval process.
• Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization.
• We presently rely on contract manufacturing organizations to produce our product candidates at development and commercial scale quantities and have not yet qualified an alternate manufacturing supply, which could negatively impact our ability to meet any future demand for the products.
• The commercial potential and profitability of our products are unknown and subject to significant risk and uncertainty.
• We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
• We have limited experience in the development and marketing of cell therapies and may be unsuccessful in our efforts to establish a profitable business.
• Our cell therapy business is based on novel technologies that are inherently expensive, risky and may not be understood by or accepted in the marketplace, which could adversely affect our future value.
• If competitors develop and market products that are more effective, safer, or less expensive than our product candidates or offer other advantages, our commercial prospects will be limited.
• Our cell therapy product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
• We may be subject to significant product liability claims and litigation, including potential exposure from the use of our product candidates in human subjects, and our insurance may be inadequate to cover claims that may arise.
• We may be unable to retain key officers or employees or hire new key officers or employees needed to implement our business strategy and develop our products and businesses.
• Our internal computer systems, or those used by our clinical investigators, clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of development programs for our product candidates.
• Cell manufacturers have a finite manufacturing capacity, which could inhibit the long-term growth prospects of our business.
• We will need to improve manufacturing efficiency at our contract manufacturers in order to establish cost of goods levels that will permit approved products to succeed commercially.
• Lack of access to safe, reliable and effective transportation options could adversely affect our ability to meet our needs.
• We are obligated to indemnify Hitachi America for certain losses resulting from breaches of the representation and warranties and covenants in the Purchase Agreement as well as for certain litigation relating to the Sale.
• We may be exposed to litigation related to the Sale from the holders of our stock.
• The development and commercialization of our product candidates is subject to extensive regulation by the FDA and other regulatory agencies in the United States and abroad, and the failure to receive regulatory approvals for our cell therapy product candidates would likely have a material and adverse effect on our business and prospects.
• We may be unsuccessful in our efforts to comply with applicable federal, state and international laws and regulations, which could result in loss of licensure, certification or accreditation or other government enforcement actions or impact our ability to secure regulatory approval of our product candidates.
• If we are unable to conduct clinical trials in accordance with regulations and accepted standards, we may be delayed in receiving, or may never receive, regulatory approvals of our product candidates from the FDA and other regulatory authorities.
• We will continue to be subject to extensive FDA regulation following any product approvals, and if we fail to comply with these regulations, we may suffer a significant setback in our business.
• Health care companies have been the subject of federal and state investigations, and we could become subject to investigations in the future.
• It is uncertain to what extent the government, private health insurers and third-party payors will approve coverage or provide reimbursement for the therapies and products to which our services relate. Availability for such reimbursement may be further limited by an increasing uninsured population and reductions in Medicare and Medicaid funding in the United States.
• Unintended consequences of health care reform legislation in the U.S. may adversely affect our business.
• Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
• Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
• Competitor companies or hospitals may be able to take advantage of EU rules permitting sales of unlicensed medicines for individual patients to sell competing products without a marketing authorization.
• A variety of risks associated with operating our business internationally could materially adversely affect our business.
• We may be unable to obtain or maintain patent protection for our products and product candidates, which could have a material adverse effect on our business.
• Litigation relating to intellectual property is expensive, time-consuming and uncertain, and we may be unsuccessful in our efforts to protect against infringement by third parties or defend ourselves against claims of infringement.
• If we are unable to maintain our licenses, patents or other intellectual property we could lose important protections that are material to continuing our operations and our future prospects.
• If we are unable to protect the confidentiality of trade secrets, our competitive position could be impaired.
• In certain countries, patent holders may be required to grant compulsory licenses, which would likely have a significant and detrimental effect on any future revenues in such country.
• Changes to U.S. patent law may have a material adverse effect on our intellectual property rights.
• Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
• Our stock price has been, and will likely continue to be, highly volatile.
• In addition to potential dilution associated with future fundraising transactions, we currently have significant numbers of securities outstanding that are exercisable for our common stock, which could result in significant additional dilution and downward pressure on our stock price.
• Sales of our common stock pursuant to our at-the-market sales agreement with H.C. Wainwright & Co. may cause substantial dilution to our existing stockholders and the sale of such shares of common stock could cause the price of our common stock to decline.
• Provisions in our amended and restated certificate of incorporation and by-laws and Delaware law may inhibit a takeover of us, which could limit the price investors might be willing to pay in the future for our common stock and could entrench management.
• Failure to maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business and stock price.
• We may fail to comply with the continued listing requirements of the Nasdaq Capital Market, such that our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.