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initiates preclinical studies for additional product candidates;

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continues its process research and development activities, as well as establishes its research-grade, clinical- and commercial-scale manufacturing capabilities (should it choose to do so directly);

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seeks collaboration agreements (geographic licensing agreements, or co-development and -commercialization agreements) involving CEND-1 and other product candidates;

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completes additional clinical trials for CEND-1, following acceptance by the FDA;

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identifies additional diseases for treatment with CEND-1 and other product candidates;

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seeks partnering agreements (sub-licensing or asset divestitures) for continued clinical development and/or commercialization and market support;

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maintains, expands and protects its intellectual property portfolio; and

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identifies, acquires or in-licenses other product candidates and/or enabling technologies.

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completing clinical development of product candidates;

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Cend’s partners may not complete clinical development or commercialization of product candidates, which could reduce Cend revenues from such partnerships;

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seeking and obtaining regulatory and marketing approvals for product candidates for which clinical trials are completed;

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launching and commercializing product candidates, including those for which Cend obtains regulatory and marketing approval, by collaborating with a commercialization partner(s);

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qualifying for adequate coverage, coding and payment, where applicable, by government and third-party payors for product candidates if and when approved;

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maintaining and enhancing a sustainable, scalable, reproducible and transferable manufacturing process for Cend’s product candidates;

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establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support development and commercial demand for product candidates, if approved;

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obtaining market acceptance of product candidates as a viable treatment option;

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addressing any competing technological and market developments;

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implementing additional internal systems and infrastructure, as needed;

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negotiating favorable terms in any collaboration, licensing or other arrangements into which Cend may enter and performing its obligations in such collaborations;

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maintaining, protecting and expanding Cend’s portfolio of intellectual property rights, including patents, trade secrets and know-how;

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avoiding and defending against third-party interference or infringement claims; and

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attracting and retaining qualified personnel.

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the scope of rights granted under the license agreement and other interpretation-related issues;

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whether and the extent to which Cend’s technology and processes infringe, misappropriate or otherwise violate intellectual property rights of the licensor that is not subject to the licensing agreement;

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Cend’s right to sublicense patent and other rights to third parties under collaborative development relationships;

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Cend’s diligence obligations with respect to the use of the licensed technology in relation to its development and commercialization of its product candidates, and what activities satisfy those diligence obligations;

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the priority of invention of any patented technology; and

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the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by Cend’s future licensors and Cend and its partners.

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infringement, misappropriation and other intellectual property claims which, regardless of merit, may be expensive and time-consuming to litigate and may divert management’s attention from Cend’s core business and may impact its reputation;

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substantial damages for infringement, misappropriation or other violations, which Cend may have to pay if a court decides that the product candidate or technology at issue infringes, misappropriates or violates the third party’s rights, and, if the court finds that the infringement was willful, Cend could be ordered to pay treble damages and the patent owner’s attorneys’ fees;

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a court prohibiting Cend from developing, manufacturing, marketing or selling its product candidates, including CEND-1, or from using its proprietary technologies, unless the third party licenses its product rights to Cend, which it is not required to do, on commercially reasonable terms or at all;

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if a license is available from a third party, Cend may have to pay substantial royalties, upfront fees and other amounts, and/or grant cross-licenses to intellectual property rights for its products, or the license to Cend may be non-exclusive, which would permit third parties to use the same intellectual property to compete with Cend;

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redesigning Cend’s product candidates or processes so they do not infringe, misappropriate or violate third party intellectual property rights, which may not be possible or may require substantial monetary expenditures and time; and

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there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and, if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of Cend’s common stock.

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successful completion of preclinical and clinical studies;

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approval of INDs for Cend’s planned clinical trials or future clinical trials;

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FDA acceptance of Cend’s development strategy and resultant clinical data;

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successful initiation of clinical trials;

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successful patient enrollment in and completion of clinical trials;

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safety, tolerability and efficacy profiles for Cend’s product candidates that are satisfactory to the FDA or any foreign regulatory authority for marketing approval;

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receipt of marketing approvals for Cend’s product candidates from applicable regulatory authorities;

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the extent of any required post-marketing approval commitments to applicable regulatory authorities;

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obtaining and maintaining patent and trade secret protection and regulatory exclusivity for Cend’s product candidates;

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making arrangements with third-party manufacturers, or establishing manufacturing capabilities, for both clinical and commercial supplies of Cend’s product candidates, if any product candidates are approved;

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establishing sales, marketing and distribution capabilities and launching commercial sales of Cend’s products, if and when approved, whether alone or in collaboration with others;

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acceptance of Cend’s products, if and when approved, by patients, the medical community and third-party payors;

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effectively competing with other cancer therapies;

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obtaining and maintaining third-party coverage and adequate reimbursement;

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maintaining a continued acceptable safety profile of Cend’s products following approval; and

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factors Cend may not be able to control, such as current or potential pandemics that may limit patients, principal investigators or staff or clinical site availability (e.g. the COVID-19 pandemic).

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the proximity of patients to clinical trial sites;

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the design of the clinical trial;

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Cend’s ability to recruit clinical trial investigators with the appropriate competencies and experience;

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Cend’s ability to obtain and maintain patient consents;

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reporting of the preliminary results of any of Cend’s clinical trials;

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the risk that patients enrolled in clinical trials will drop out of the clinical trials before clinical trial completion; and

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other unforeseeable conditions, such as COVID-19, which had a significantly negative impact on the availability of enrollment in clinical trials.

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regulatory authorities may withdraw or limit their approval of such product candidates;

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regulatory authorities may require the addition of labeling statements, such as a “boxed” warning or a contraindication;

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Cend may be required to change the way such product candidates are distributed or administered, conduct additional clinical trials or change the labeling of the product candidates;

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regulatory authorities may require a REMS plan to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools;

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Cend may be subject to regulatory investigations and government enforcement actions;

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Cend may decide to remove such product candidates from the marketplace;

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Cend could be sued and held liable for injury caused to individuals exposed to or taking its product candidates; and

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Cend’s reputation may suffer.

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the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of Cend’s clinical trials;

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the FDA or comparable foreign regulatory authorities disagreeing with Cend’s tumor-agnostic development strategy;

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delays in obtaining regulatory approval to commence a clinical trial;

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reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

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obtaining IRB approval at each clinical trial site;

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recruiting an adequate number of suitable patients to participate in a clinical trial;

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the number of patients required for clinical trials of Cend’s product candidates may be larger than it anticipates;

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having subjects complete a clinical trial or return for post-treatment follow-up;

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clinical trial sites deviating from clinical trial protocol or dropping out of a clinical trial;

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addressing subject safety concerns that arise during the course of a clinical trial;

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adding a sufficient number of clinical trial sites; or

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obtaining sufficient product supply of product candidate for use in non-clinical studies or clinical trials from third-party suppliers.

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Cend may receive feedback from regulatory authorities that requires it to modify the design of its clinical trials;

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clinical trials of Cend’s product candidates may produce negative or inconclusive results, and Cend may decide, or regulators may require it, to conduct additional clinical trials or abandon its research efforts for its other product candidates;

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clinical trials of Cend’s product candidates may not produce differentiated or clinically significant results across tumor types or indications;

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the number of patients required for clinical trials of Cend’s product candidates may be larger than it anticipates, enrollment in these clinical trials may be slower than it anticipates or participants may drop out of its clinical trials at a higher rate than it anticipates;

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Cend’s third-party contractors may fail to comply with regulatory requirements, fail to maintain adequate quality controls or be unable to provide it with sufficient product supply to conduct and complete preclinical studies or clinical trials of Cend’s product candidates in a timely manner, or at all;

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Cend or its investigators might have to suspend or terminate clinical trials of Cend’s product candidates for various reasons, including non-compliance with regulatory requirements, a finding that Cend’s product candidates have undesirable side effects or other unexpected characteristics or a finding that the participants are being exposed to unacceptable health risks;

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the cost of clinical trials of Cend’s product candidates may be greater than it anticipates, for example, if it experiences delays or challenges in identifying patients with the mutations required for its clinical trials, it may have to reimburse sites for genetic sequencing costs in order to encourage sequencing of additional patients;

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the quality of Cend’s product candidates or other materials necessary to conduct preclinical studies or clinical trials of Cend’s product candidates may be insufficient or inadequate, and any transfer of manufacturing activities may require unforeseen manufacturing or formulation changes;

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regulators may revise the requirements for approving Cend’s product candidates, or such requirements may not be as it anticipates; and

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future collaborators may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for Cend.

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differing regulatory requirements in foreign countries, for example, no country other than the United States has a pathway for accelerated drug approval and so obtaining regulatory approvals outside of the United States will take longer and be more costly than obtaining approval in the United States;

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unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;

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economic weakness, including inflation, or political instability in particular foreign economies and markets;

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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

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foreign taxes, including withholding of payroll taxes;

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foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;

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difficulties staffing and managing foreign operations;

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workforce uncertainty in countries where labor unrest is more common than in the United States;

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potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign regulations;

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challenges enforcing Cend’s contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;

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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

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business interruptions resulting from geo-political actions, including war and terrorism.

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the clinical indications for which Cend’s product candidates are licensed;

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physicians, hospitals, cancer treatment centers and patients considering Cend’s product candidates as a safe and effective treatment;

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the potential and perceived advantages of Cend’s product candidates over alternative treatments;

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Cend’s ability to demonstrate the advantages of its product candidates over other cancer medicines;

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the prevalence and severity of any side effects;

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the prevalence and severity of any side effects for other precision medicines and public perception of other precision medicines;

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product labeling or product insert requirements of the FDA or other regulatory authorities;

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limitations or warnings contained in the labeling approved by the FDA;

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the timing of market introduction of Cend’s product candidates as well as competitive products;

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the cost of treatment in relation to alternative treatments;

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the availability of adequate coverage, reimbursement and pricing by third-party payors and government authorities;

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the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors and government authorities;

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relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and

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the effectiveness of Cend’s sales and marketing efforts.

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continues its research and development efforts and submits INDs for its lead product candidates;

•

conducts preclinical studies and clinical trials for its current and future product candidates

•

seeks marketing approvals for any product candidates that successfully complete clinical trials;

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experiences any delays or encounter any issues with any of the above, including but not limited to failed studies, complex results, safety issues or other regulatory challenges;

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establishes a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities, whether alone or with third parties, to commercialize any product candidates for which it may obtain regulatory approval, if any;

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obtains, expands, maintains, enforces and protects its intellectual property portfolio; and

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hires additional clinical, regulatory and scientific personnel.

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restrictions on the marketing or manufacturing of Cend’s product candidates, withdrawal of the product from the market or voluntary or mandatory product recalls;

•

manufacturing delays and supply disruptions where regulatory inspections identify observations of noncompliance requiring remediation;

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revisions to the labeling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings;

•

imposition of a REMS, which may include distribution or use restrictions;

•

requirements to conduct additional post-market clinical trials to assess the safety of the product;

•

fines, warning letters or holds on clinical trials;

•

refusal by the FDA to approve pending applications or supplements to approved applications filed by Cend or suspension or revocation of approvals;

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product seizure or detention, or refusal to permit the import or export of Cend’s product candidates; and

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injunctions or the imposition of civil or criminal penalties.

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a covered benefit under its health plan;

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safe, effective and medically necessary;

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appropriate for the specific patient;

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cost-effective; and

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neither experimental nor investigational.

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the demand for our product candidates, if Cend obtains regulatory approval;

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Cend’s ability to receive or set a price that it believes is fair for its products;

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Cend’s ability to generate revenue and achieve or maintain profitability;

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Cend’s ability to enjoy or maintain market exclusivity;

•

the level of taxes that Cend is required to pay; and

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the availability of capital.

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the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Violations are subject to civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the Federal False Claims Act. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution;

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federal civil and criminal false claims laws and civil monetary penalty laws, including the Federal False Claims Act, which impose criminal and civil penalties, including through civil “qui tam” or “whistleblower” actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other federal health care programs that are false or fraudulent; knowingly making or causing a false statement material to a false or fraudulent claim or an obligation to pay money to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing such an obligation. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. When an entity is determined to have violated the Federal False Claims Act, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

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HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it;

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions;

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the federal Physician Payment Sunshine Act, created under the ACA and its implementing regulations, which require manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Effective January 1, 2022, these reporting obligations extend to include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners;

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federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and

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analogous state and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition laws which may apply to pharmaceutical business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensations and other remuneration and items of value provided to healthcare professionals and entities; state and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

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collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;

•

collaborators may not pursue development and commercialization of Cend’s product candidates or may elect not to continue or renew development or commercialization of Cend’s product candidates based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;

•

collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

•

collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with Cend’s product candidates;

•

a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;

•

collaborators may not properly maintain or defend Cend’s intellectual property rights or may use Cend’s intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate Cend’s intellectual property or proprietary information or expose Cend to potential liability;

•

disputes may arise between Cend and a collaborator that cause the delay or termination of the research, development or commercialization of Cend’s product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;

•

collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and

•

collaborators may own or co-own intellectual property covering Cend’s products that results from Cend’s collaborating with them, and in such cases, Cend would not have the exclusive right to commercialize such intellectual property.

•

identifying, recruiting, integrating, maintaining and motivating additional employees;

•

Advance applications of Cend’s drug discovery and development platform;

•

managing Cend’s internal development efforts effectively, including the clinical and FDA review process for Cend’s product candidates, while complying with Cend’s contractual obligations to contractors and other third parties; and

•

improving Cend’s operational, financial and management controls, reporting systems and procedures.

•

decreased demand for Cend’s product candidates or products that it may develop;

•

injury to Cend’s reputation;

•

withdrawal of clinical trial participants;

•

initiation of investigations by regulators;

•

costs to defend the related litigation;

•

a diversion of management’s time and Cend’s resources;

•

substantial monetary awards to trial participants or patients;

•

product recalls, withdrawals or labeling, marketing or promotional restrictions;

•

loss of revenue;

•

exhaustion of any available insurance and Cend’s capital resources;

•

the inability to commercialize any product candidate; and

•

a decline in share price.

•

results of clinical trials and preclinical studies of the combined company’s product candidates, or those of the combined company’s competitors or the combined company’s existing or future collaborators;

•

failure to meet or exceed financial and development projections the combined company may provide to the public;

•

failure to meet or exceed the financial and development projections of the investment community;

•

if the combined company does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by financial or industry analysts;

•

announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by the combined company or its competitors;

•

actions taken by regulatory agencies with respect to the combined company’s product candidates, clinical studies, manufacturing process or sales and marketing terms;

•

disputes or other developments relating to proprietary rights, including patents, litigation matters, and the combined company’s ability to obtain patent protection for its technologies;

•

additions or departures of key personnel;

•

significant lawsuits, including patent or stockholder litigation;

•

if securities or industry analysts do not publish research or reports about the combined company’s business, or if they issue adverse or misleading opinions regarding its business and stock;

•

changes in the market valuations of similar companies;

•

general market or macroeconomic conditions or market conditions in the pharmaceutical and biotechnology sectors;

•

sales of securities by the combined company or its securityholders in the future;

•

if the combined company fails to raise an adequate amount of capital to fund its operations and continued development of its product candidates;

•

trading volume of the Caladrius Common Stock;

•

announcements by competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments;

•

adverse publicity relating to precision medicine product candidates, including with respect to other products in such markets;

•

the introduction of technological innovations or new therapies that compete with the products and services of the combined company; and

•

period-to-period fluctuations in the combined company’s financial results.