Item 1A. Risk Factors.

Risks

Related to Capital and Our Operations

We will require additional capital in order

to continue our operations and may have difficulty raising additional capital.

We expect that we will continue to generate

operating losses for the foreseeable future. At December 31, 2020, our consolidated cash balance was approximately $57.2 million.

We believe our cash balance at December 31, 2020, is adequate to fund our basic budgeted operations for at least 12 months from

the filing of this annual report. We will require additional funds to conduct research and development, establish and conduct clinical

and preclinical studies, establish commercial-scale manufacturing arrangements and provide for the marketing and distribution of

our products. Our ability to execute our operating plan depends on our ability to obtain additional funding via the sale of equity

and/or debt securities, a strategic transaction or otherwise. We plan to actively pursue financing alternatives. However, there

can be no assurance that we will obtain the necessary funding in the amounts we seek or that it will be available on a timely basis

or upon terms acceptable to us. If we obtain capital by issuing debt or preferred stock, the holders of such securities would likely

obtain rights that are superior to those of holders of our common stock.

Our capital requirements and our ability

to meet them depend on many factors, including:

· the number of potential products and technologies in development;

· continued progress and cost of our research and development programs;

· progress with preclinical studies and clinical studies;

· the time and costs involved in obtaining regulatory clearance;

· competing technological and market developments;

· claims or enforcement actions with respect to our products or operations;

· market acceptance of our products;

· costs for recruiting and retaining management, employees and consultants;

· our ability to manage computer system failures or security breaches;

· whether we are able to maintain our listing on a national exchange;

We may consume

available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than

expected. We may seek to raise any additional funds through the issuance of any combination of common stock, preferred stock,

warrants and debt financings or by executing collaborative arrangements with corporate partners or other sources, any of

which may be dilutive to existing stockholders or have a material effect on our current or future business prospects. If we

cannot secure adequate financing when needed, we may be required to delay, scale back or eliminate one or more of our

research and development programs or to enter into license or other arrangements with third parties to commercialize products

or technologies that we would otherwise seek to develop and commercialize ourselves. In the event that additional funds are

obtained through arrangements with collaborative partners or other sources, we may have to relinquish economic and/or

proprietary rights to some of our technologies or products under development that we would otherwise seek to develop or

commercialize by ourselves. In such an event, our business, prospects, financial condition and results of operations may be

adversely affected.

The COVID-19 pandemic could materially and adversely

affect our business.

The COVID-19 pandemic could significantly

disrupt our business and may prevent us from conducting business activities due to spread of the disease, or due to shutdowns that

may be requested or mandated by federal, state and local governmental authorities. Business disruptions have included restrictions

on our ability to travel, as well as temporary closures. While we have not yet experienced any significant impacts as a result

of the pandemic, it is not possible at this time to estimate the ultimate impact that it could have on our business. The continued

rapid spread of COVID-19 including new virus strains and the measures taken by government authorities has created uncertainties

and could delay our ongoing clinical studies or the manufacture or shipment of CLR 131 for clinical studies.

We continue to evaluate the impact COVID-19

may have on our ability to effectively conduct our business. Our clinical trial sites may be affected by travel or quarantine

restrictions imposed by federal, state or local governments. We may in the future need to update or suspend our clinical studies

as a result of the pandemic. In addition, we have made and we (and our CROs) may need to make certain adjustments to the operation

of clinical studies in an effort to ensure the monitoring and safety of patients and minimize risks to trial data integrity during

the pandemic in accordance with the guidance issued by the FDA in 2020, which describes a number of considerations for sponsors

of clinical studies impacted by the pandemic, including, among other requirements, the requirements to include in the clinical

trial report contingency measures implemented to manage the clinical trial, any disruption of the clinical trial as

a result of the COVID-19 pandemic, and analyses and corresponding discussions that address the impact of implemented contingency

measures on the safety and efficacy results reported for the clinical trial. To the extent we (or our third-party suppliers

and manufacturers) are required to implement additional or to modify existing policies and procedures for our clinical studies

and/or manufacturing functions, or if the pandemic significantly impacts recruitment of patients or the conduct of our clinical

studies, our anticipated timelines for initiating or completing clinical studies and seeking regulatory approval may be substantially

delayed, and we may incur additional costs. Also, to the extent FDA and other regulatory authorities experience any delays or limited

resources in reviewing our regulatory applications or requests for meetings and/or guidance, and inspection of manufacturing facilities

prior to regulatory approval due to the COVID-19 pandemic or other reasons, we may experience significant delays in our anticipated

timelines for our clinical studies and/or seeking regulatory approvals, which could adversely affect our business.

Although we expect no material impact

on the supply of CLR 131 for our current clinical studies, should our third-party manufacturers experience extended disruptions,

we could experience delays in future trials. Further, in June 2020, FDA issued a guidance on good manufacturing practice considerations

for responding to COVID-19 infection in employees in drug products manufacturing, including recommendations for manufacturing controls

to prevent contamination of drugs. Such guidance and any future guidance or regulatory requirements impacting drug product manufacturing,

including delays associated with complying with new requirements, could impact the operations of our contract manufacturers, our

business, and our ability to obtain sufficient supplies for our clinical development on a timely basis.

The COVID-19 pandemic continues to rapidly

evolve. While the extent of the impact of the COVID-19 pandemic on our business and financial results is uncertain, a continued

and prolonged public health crisis could have a material negative impact on our business, financial condition and operating results.

To the extent that COVID-19 pandemic impacts our business in any way, it may also have the effect of heightening the impact of

other risk factors disclosed herein.

Conflicts, military actions, terrorist attacks,

natural disasters. public health crises, including the occurrence of a contagious disease or illness, such as the COVID-19 coronavirus,

cyber-attacks and general instability could adversely affect our business.

Conflicts,

military actions, terrorist attacks, natural disasters, public health crises and cyber-attacks have precipitated economic

instability and turmoil in financial markets. Instability and turmoil may result in raw material cost increases. The uncertainty

and economic disruption resulting from hostilities, military action, acts of terrorism, public health crises or cyber-attacks may

impact our operations or those of our suppliers. Accordingly, any conflict, military action, terrorist attack, public health crises

or cyber-attack that impacts us or any of our suppliers, could have a material adverse effect on our business, liquidity, prospects,

financial condition and results of operations.

Our business and operations may be materially

adversely affected in the event of computer system failures or security breaches.

Despite

the implementation of security measures, our internal computer systems, and those of our third-party manufacturers, contract research

organizations and other third parties on which we rely, are vulnerable to damage from computer viruses, unauthorized access, cyber-attacks,

phishing attempts, natural disasters, fire, terrorism, war and telecommunication and

electrical failures. If such an event were to occur and interrupt our operations, it could result in a material disruption in our

business. For example, the loss of clinical study data from ongoing or planned clinical studies could result in delays in our regulatory

approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security

breach results in a loss of or damage to our data or applications, loss of trade secrets, inappropriate disclosure of confidential

or proprietary information, including protected health information or personal data of employees or former employees, lack of access

to our clinical data, or disruption of the manufacturing process, we could incur liability and the further development of our drug

candidates could be delayed. We may also be vulnerable to cyber-attacks or other malfeasance by hackers. This type of breach of

our cybersecurity may compromise our confidential and financial information, adversely affect our business, or result in legal

proceedings. Further, these cybersecurity breaches may inflict reputational harm upon us that may result in decreased market value

and erode public trust.

Risks Related to Manufacturing and Supply

We rely on a collaborative outsourced business

model, and disruptions with our third-party collaborators, including potential disruptions at our sole source supplier of CLR 131,

Centre for Probe Development and Commercialization, CPDC, may impede our ability to gain FDA approval and delay or impair commercialization

of any products.

We are in the preclinical and clinical

study phases of product development and commercialization. We have closed manufacturing operations located at our corporate headquarters,

and have implemented a collaboration outsourcing model to more efficiently manage costs. We rely significantly on contracts with

third parties to use their facilities to conduct our research, development and manufacturing.

We have engaged CPDC, which has been a

validated cGMP manufacturing organization specializing in radiopharmaceuticals, as our exclusive source to supply drug product

for our ongoing research and clinical studies, including our Phase 1 and Phase 2 studies of CLR 131.

In addition, we rely exclusively on contract

research organizations to conduct research and development. Any inability of these organizations to fulfill the requirements of

their agreements with us may delay or impair our ability to gain FDA approval and commercialization of our drug delivery technology

and products.

Our reliance on third-party collaborators

exposes us to risks related to not being able to directly oversee the activities of these parties. Furthermore, these collaborators,

whether foreign or domestic, may experience regulatory compliance difficulties, mechanical shutdowns, employee strikes, or other

unforeseeable acts that may delay fulfillment of their agreements with us. Failure of any of these collaborators to provide the

required services in a timely manner or on commercially reasonable terms could materially delay the development and approval of

our products, increase our expenses, and materially harm our business, prospects, financial condition and results of operations.

We believe that

we have a good working relationship with our third-party collaborators. However, should the situation change, we may be

required to relocate these activities on short notice, and we do not currently have access to alternate facilities to which

we could relocate our research, development and/or manufacturing activities. The cost and time to establish or locate an

alternate research, development and/or manufacturing facility to develop our technology would be substantial and would delay

obtaining FDA approval and commercializing our products.

Furthermore, if our products are approved

for commercial sale, we will need to work with our existing third-party collaborators to ensure sufficient capacity, or engage

additional parties with the capacity, to commercially manufacture our products in accordance with FDA and other regulatory requirements.

There can be no assurance that we would be able to successfully establish any such capacity or identify suitable manufacturing

partners on acceptable terms.

Risks

Related to Research and Development and the FDA

We cannot

assure the successful development and commercialization of our compounds in development.

At present, our success is dependent on

one or more of the following to occur: the successful development of CLR 131 for the treatment of a hematologic or solid tumor

cancer including Waldenstrom’s macroglobulinemia, multiple myeloma and B-Cell lymphomas or the treatment of pediatric

solid tumors and lymphomas; the development of new PDCs, specifically new products developed from our PDC program, and the advancement

of our PDC agents through research and development; and/or commercialization partnerships.

We are a late-stage clinical biopharmaceutical

company focused on the discovery, development and commercialization of drugs for the treatment of cancer. We leverage our PDC platform

to specifically target treatments to cancer cells. The PDC platform possesses the potential for the discovery and development of

the next generation of cancer-targeting agents. The PDC platform features include the capacity to link with almost any molecule,

the delivery of a significant increase in targeted oncologic payload, and the ability to target all tumor cells. As a result, we

believe that we can generate PDCs to treat a broad range of cancers with the potential to improve the therapeutic index of oncologic

drug payloads, enhance or maintain efficacy while reducing adverse events by minimizing drug delivery to healthy cells, and increase

delivery to cancerous cells and cancer stem cells.

Our proposed products and their potential

applications are in clinical and manufacturing/process development and face a variety of risks and uncertainties, including the

following:

If we are unsuccessful in dealing with

any of these risks, or if we are unable to successfully advance the development of our cancer-targeting and delivery technologies

for some other reason, our business, prospects, financial condition and results of operations may be adversely affected.

Failure to complete the development of our

technologies, obtain government approvals, including required FDA approvals, or comply with ongoing governmental regulations could

prevent, delay or limit introduction or sale of proposed products and result in failure to achieve revenues or maintain our ongoing

business.

Our research and development activities

and the manufacture and marketing of our intended products are subject to extensive regulation for safety, efficacy and quality

by numerous government authorities in the U.S. and abroad. Before receiving approval to market our proposed products by the FDA,

we will have to demonstrate that our products are safe and effective for the patient population for the diseases that are to be

treated. Clinical studies, manufacturing and marketing of drugs are subject to the rigorous testing and approval process of the

FDA and equivalent foreign regulatory authorities. The Federal Food, Drug, and Cosmetic Act and other federal, state and foreign

statutes and regulations govern and influence the testing, manufacturing, labeling, advertising, distribution and promotion of

drugs and medical devices. As a result, clinical studies and regulatory approval can take many years to accomplish and require

the expenditure of substantial financial, managerial and other resources.

In addition to the required regulatory

approval described above, in order to be commercially viable, we must successfully research, develop, manufacture, introduce, market

and distribute our technologies. This includes meeting a number of critical developmental milestones, including:

The timeframe necessary to achieve these

developmental milestones may be long and uncertain, and we may not successfully complete these milestones for any of our intended

products in development.

In addition to the risks previously discussed,

our technology is subject to developmental risks that include the following:

In order to conduct the clinical studies

that are necessary to obtain approval by the FDA to market a product, it is necessary to receive clearance from the FDA to conduct

such clinical studies. The FDA can halt clinical studies at any time for safety reasons or because we or our clinical investigators

do not follow the FDA’s requirements for conducting clinical studies. If any of our studies are halted, we will not be able

to obtain FDA approval until and unless we can address the FDA’s concerns. If we are unable to receive clearance to conduct

clinical studies for a product, we will not be able to achieve any revenue from that product in the U.S., as it is illegal to sell

any drug for use in humans in the U.S. without FDA approval.

Even if we do ultimately receive FDA approval

for any of our products, these products will be subject to extensive ongoing regulation, including regulations governing manufacturing,

labeling, packaging, testing, dispensing, prescription and procurement quotas, record keeping, reporting, handling, shipment and

disposal of any such drug. Failure to obtain and maintain required registrations or to comply with any applicable regulations could

further delay or preclude development and commercialization of our drugs and subject us to enforcement action.

The FDA has granted rare pediatric disease

designation, RPDD, to CLR 131 for treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma; however,

we may not be able to realize any value from such designation.

Our CLR 131 compound has received RPDD designation from the

FDA for the treatment of neuroblastoma, rhabdomyosarcoma, osteosarcoma and Ewing’s sarcoma. The FDA defines a “rare

pediatric disease” as a disease that affects fewer than 200,000 individuals in the U.S. primarily under the age of 18 years

old. Under the FDA’s Rare Pediatric Disease Priority Review Voucher Program, upon the approval of an NDA or a BLA for the

treatment of a rare pediatric disease, the sponsor of such application could be eligible for a Rare Pediatric Disease Priority

Review Voucher that can be used to obtain priority review for a subsequent NDA or BLA. There is no assurance we will receive a

Rare Pediatric Disease Priority Review Voucher or that it will result in a faster development process, review or approval for a

subsequent marketing application. Also, although Priority Review Vouchers may be sold or transferred to third parties, there is

no guaranty that we will be able to realize any value if we were to sell a Priority Review Voucher. In December 2020, the Priority

Review Voucher Program was extended by the FDA permitting additional grants through September 2026 for rare pediatric diseases.

It is possible that even if we obtain approval for CLR 131 and qualify for a priority review voucher, the program may no longer

be in effect at the time of such approval.

Clinical studies involve a

lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.

In order to obtain regulatory approval

for the commercialization of our product candidates, we must conduct, at our own expense, extensive clinical studies to demonstrate

safety and efficacy of these product candidates. Clinical testing is expensive, it can take many years to complete, and its outcome

is uncertain. Failure can occur at any time during the clinical study process.

We may experience delays in clinical testing

of our product candidates. We do not know whether planned clinical studies will begin on time, need to be redesigned, or be completed

on schedule, if at all. Clinical studies can be delayed for a variety of reasons, including delays in obtaining regulatory approval

to commence a study, reaching agreement on acceptable clinical study terms with prospective sites, obtaining institutional review

board approval to conduct a study at a prospective site, recruiting patients to participate in a study, or obtaining sufficient

supplies of clinical study materials. Many factors affect patient enrollment, including the size of the patient population, the

proximity of patients to clinical sites, the eligibility criteria for the study, competing clinical studies, and new drugs approved

for the conditions we are investigating. Prescribing physicians will also have to decide to use our product candidates over existing

drugs that have established safety and efficacy profiles or other drugs undergoing development in clinical studies. Any delays

in completing our clinical studies will increase our costs, slow down our product development and approval process, and delay our

ability to generate revenue.

In addition, the results of preclinical

studies and early clinical studies of our product candidates do not necessarily predict the results of later-stage clinical studies.

Product candidates in later stages of clinical studies may fail to show the desired safety and efficacy traits despite having progressed

through initial clinical testing. The data collected from clinical studies of our product candidates may not be sufficient to support

the submission of an NDA or to obtain regulatory approval in the U.S. or elsewhere. Because of the uncertainties associated with

drug development and regulatory approval, we cannot determine if or when we will have an approved product for commercialization

or will achieve sales or profits.

Our clinical studies may not demonstrate

sufficient levels of efficacy necessary to obtain the requisite regulatory approvals for our drugs, and our proposed drugs may

not be approved for marketing.

We may be required to suspend or discontinue

clinical studies due to unexpected side effects or other safety risks that could preclude approval of our product candidates.

Our clinical

studies may be suspended at any time for a number of reasons. For example, we may voluntarily suspend or terminate our

clinical studies if at any time we believe that they present an unacceptable risk to the clinical study patients. In

addition, regulatory agencies may order the temporary or permanent discontinuation of our clinical studies at any time if

they believe that the clinical studies are not being conducted in accordance with applicable regulatory requirements or that

they present an unacceptable safety risk to the clinical study patients.

Administering any product candidates to

humans may produce undesirable side effects. These side effects could interrupt, delay or halt clinical studies of our product

candidates and could result in the FDA or other regulatory authorities denying further development or approval of our product candidates

for any or all targeted indications. Ultimately, some or all of our product candidates may prove to be unsafe for human use. Moreover,

we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health effects

as a result of participating in our clinical studies.

Risks Related to Legal Compliance and Litigation

Controls we or our third-party collaborators

have in place to ensure compliance with all applicable laws and regulations may not be effective.

We and our third-party collaborators are

subject to federal, state and local laws and regulations governing the storage, use and disposal of hazardous materials and waste

products. Current or future regulations may impair our research, development, manufacturing and commercialization efforts. The

inability of our third-party collaborators to maintain the required licenses and permits for any reason will negatively impact

our manufacturing, research and development activities. In addition, we may be required to indemnify third-party collaborators

against certain liabilities arising out of any failure by them to comply with such regulations and/or laws. If we or our third

party collaborators fail to comply with any of these regulations and/or laws, a range of consequences could result, including the

suspension or termination of clinical studies, failure to obtain approval of a product candidate, restrictions on our products

or manufacturing processes, withdrawal of our products from the market, significant fines, exclusion from government healthcare

programs, or other sanctions or litigation.

We are exposed to product, clinical and preclinical

liability risks that could create a substantial financial burden should we be sued.

Our

business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing and

marketing of pharmaceutical products. In addition, the use in our clinical studies of pharmaceutical products that we, or our current

or potential collaborators, may develop and then subsequently sell, may cause us to bear a portion of, or all, product liability

risks. While we carry an insurance policy covering up to $5,000,000 per occurrence and $5,000,000 in the aggregate for liability

incurred in connection with such claims should they arise, there can be no assurance that our insurance will be adequate to cover

all situations. Moreover, there can be no assurance that such insurance, or additional insurance if required, will be available

or, if available, will be available on commercially reasonable terms. Furthermore, our current and potential partners with whom

we have collaborative agreements, or our future licensees, may not be willing to indemnify us against these types of liabilities

and may not themselves be sufficiently insured or have a net worth sufficient to satisfy any product liability claims. A successful

product liability claim or series of claims brought against us could have a material adverse effect on our business, prospects,

financial condition and results of operations.

Risks

Related to Intellectual Property

We expect to rely on our patents as well as

specialized regulatory designations such as orphan drug classification for our product candidates, but regulatory drug designations

may not confer marketing exclusivity or other expected commercial benefits.

We expect to

file for ODD or other regulatory designations (fast track, break-through, priority review, etc.) as appropriate for our

product candidates. Orphan drug status confers seven years of marketing exclusivity under the Federal Food, Drug, and

Cosmetic Act in the U.S., and up to ten years of marketing exclusivity in Europe for a particular product in a specified

indication. We have been granted ODD in the U.S. for CLR 131 as a therapeutic for the treatment of multiple myeloma,

neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing’s sarcoma and lymphoplasmacytic lymphoma/Waldenstrom’s

macroglobulinemia. Additionally, we have been granted ODD in Europe for CLR 131 as a therapeutic for the treatment of

multiple myeloma and Waldenstrom’s macroglobulinemia. While we have been granted this orphan designation, we will not

be able to rely on it to exclude other companies from manufacturing or selling products using the same principal molecular

structural features for the same indication beyond these timeframes without our patent portfolio. For any product candidate

for which we have been or will be granted ODD in a particular indication, it is possible that another company also holding

ODD for the same product candidate will receive marketing approval for the same indication before we do. If that were to

happen, our applications for that indication may not be approved until the competing company’s period of exclusivity

expires. Even if we were the first to obtain marketing authorization for an orphan drug indication, there are circumstances

under which a competing product may be approved for the same indication during the seven-year period of marketing

exclusivity, such as if the later product is shown to be clinically superior to the orphan product or deemed a different

product than ours. Further, the seven-year marketing exclusivity would not prevent competitors from obtaining approval of the

same product candidate as ours for indications other than those in which we have been granted ODD, or for other indications

if not for our patent portfolio, or for the use of other types of products in the same indications as our orphan product.

Furthermore, although the ODD and exclusivity are in effect right now, the FDA has the authority to modify this assessment at

any time.

We may face litigation from third parties

claiming our products infringe on their intellectual property rights, particularly because there is often substantial uncertainty

about the validity and breadth of medical patents.

We may be exposed to future litigation

by third parties based on claims that our technologies, products or activities infringe on the intellectual property rights of

others or that we have misappropriated the trade secrets of others. This risk is exacerbated by the fact that the validity and

breadth of claims covered in medical technology patents, and the breadth and scope of trade-secret protection, involve complex

legal and factual questions for which important legal principles are unresolved. Any litigation or claims against us, whether valid

or not, could result in substantial costs, place a significant strain on our financial and managerial resources, and harm our reputation.

License agreements that we may enter into in the future would likely require that we pay the costs associated with defending this

type of litigation. In addition, intellectual property litigation or claims could force us to do one or more of the following:

· redesign our products, which would be costly and time-consuming.

If we are unable to adequately protect or enforce

our rights to intellectual property or to secure rights to third-party patents, we may lose valuable rights, experience reduced

market share, assuming any, or incur costly litigation to protect our intellectual property rights.

Our ability to obtain licenses to patents,

maintain trade-secret protection, and operate without infringing the proprietary rights of others will be important to commercializing

any products under development. Therefore, any disruption in access to the technology could substantially delay the development

of our technology.

The patent positions of biotechnology and

pharmaceutical companies, such as ours, for products that involve licensing agreements are frequently uncertain and involve complex

legal and factual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the

patent is issued or in subsequent legal proceedings. Consequently, our patent applications and any issued and licensed patents

may not provide protection against competitive technologies or may be held invalid if challenged or circumvented. To the extent

we license patents from third parties, the early termination of any such license agreement would result in the loss of our rights

to use the covered patents, which could severely delay, inhibit or eliminate our ability to develop and commercialize compounds

based on the licensed patents. Our competitors may also independently develop products similar to ours or design around or otherwise

circumvent patents issued or licensed to us. In addition, the laws of some foreign countries may not protect our proprietary rights

to the same extent as U.S. law.

We also rely on

trade secrets, technical know-how and continuing technological innovation to develop and maintain our competitive position.

Although we generally require our employees, consultants, advisors and collaborators to execute appropriate confidentiality

and assignment-of-inventions agreements, our competitors may independently develop substantially equivalent proprietary

information and techniques, reverse engineer our information and techniques, or otherwise gain access to our proprietary

technology. We may be unable to meaningfully protect our rights in trade secrets, technical know-how and other nonpatented

technology.

We may have to resort to litigation to

protect our rights for certain intellectual property or to determine the scope, validity or enforceability of our intellectual

property rights. Enforcing or defending our rights would be expensive, could cause diversion of our resources, and may not prove

successful. Any failure to enforce or protect our rights could cause us to lose the ability to exclude others from using our technology

to develop or sell competing products.

Risks Related to Our Employees

We rely on

a small number of key personnel who may terminate their employment with us at any time, and our success will depend on our ability

to hire additional qualified personnel.

Our success depends to a significant degree

on the continued services of our executive officers, including our Chief Executive Officer, James V. Caruso. Our management and

other employees may voluntarily terminate their employment with us at any time, and there can be no assurance that these individuals

will continue to provide services to us. Our success will depend on our ability to attract and retain highly skilled personnel.

We may be unable to recruit such personnel on a timely basis, if at all. The loss of services of key personnel, or the inability

to attract and retain additional qualified personnel, could result in delays in development or approval of our products, loss of

sales and diversion of management resources.

Confidentiality agreements with employees and

others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect

our intellectual property, which could limit our ability to compete.

We operate in the highly technical field

of research and development of small-molecule drugs and rely, in part, on trade-secret protection in order to protect our proprietary

trade secrets and unpatented know-how. However, trade secrets are difficult to protect, and we cannot be certain that our competitors

will not develop the same or similar technologies on their own. We have taken steps, including entering into confidentiality agreements

with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors, to protect our trade

secrets and unpatented know-how. These agreements generally require that the other party keep confidential and not disclose to

third parties all confidential information developed by the party or made known to the party by us during the course of the party’s

relationship with us. Also, we typically obtain agreements from these parties that inventions conceived by them in the course of

rendering services to us will be our exclusive property. However, these agreements may not be honored and may not effectively assign

intellectual property rights to us. Enforcing a claim that a party has illegally obtained, and is using our trade secrets or know-how,

is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, courts outside the U.S. may be less

willing to protect trade secrets or know-how. The failure to obtain or maintain trade-secret protection could adversely affect

our competitive position.

We may be subject to claims that our employees

have wrongfully used or disclosed alleged trade secrets of their current or former employers.

As is common in the biotechnology and pharmaceutical

industry, we engage individuals who were previously employed at other biotechnology or pharmaceutical companies, including our

competitors or potential competitors or who are employed by academic research institutions. Although no claims against us are currently

pending, we may be subject to claims that we, or these employees, have used or disclosed trade secrets or other proprietary information

of their current or former employers, either inadvertently or otherwise. Litigation may be necessary to defend against these claims.

Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction

to management.

Risks

Related to Commercialization of our Products

Acceptance of our products in the marketplace

is uncertain and failure to achieve market acceptance will prevent or delay our ability to generate revenues.

Our future financial performance will depend,

at least in part, on the introduction and customer acceptance of our proposed products. Even if approved for marketing by the necessary

regulatory authorities, our products may not achieve market acceptance. The degree of market acceptance will depend on a number

of factors including:

· marketing our products.

Physicians, patients, payors or the medical

community, in general, may be unwilling to accept, use or recommend any of our products. If we are unable to obtain regulatory

approval or commercialize and market our proposed products as planned, we may not achieve any market acceptance or generate revenue.

The market for our proposed products is rapidly

changing and competitive, and new therapeutics, drugs and treatments that may be developed by others could impair our ability to

develop our business or become competitive.

The pharmaceutical and biotechnology industries

are subject to rapid and substantial technological change. Developments by others may render our technologies and proposed products

noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other market factors. Technological

competition from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the

field is intense and expected to increase. Most of these entities have significantly greater research and development capabilities

and budgets than we do, as well as substantially more marketing, manufacturing, financial and managerial resources. These entities

represent significant competition for us. Acquisitions of, or investments in, competing pharmaceutical or biotechnology companies

by large corporations could increase our competitors’ financial, marketing, manufacturing and other resources.

Our resources are limited, and we may experience

management, operational or technical challenges inherent in our activities and novel technologies. Competitors have developed,

or are in the process of developing, technologies that are, or in the future may be, the basis for competition. Some of these technologies

may accomplish therapeutic effects similar to those of our technology, but through different means. Our competitors may develop

drugs and drug delivery technologies that are more effective than our intended products and, therefore, present a serious competitive

threat to us.

The potential widespread acceptance of

therapies that are alternatives to ours may limit market acceptance of our products even if they are commercialized. Many of our

targeted diseases and conditions can also be treated by other medication or drug delivery technologies. These treatments may be

widely accepted in medical communities and have a longer history of use. The established use of these competitive drugs may limit

the potential for widespread acceptance of our technologies and products if commercialized.

Due to continued changes in marketing, sales

and distribution, we may be unsuccessful in our efforts to sell our proposed products, develop a direct sales organization, or

enter into relationships with third parties.

We have not

established marketing, sales or distribution capabilities for our proposed products. Until such time as our proposed products

are further along in the development process, we will not devote any meaningful time and resources to this effort. At the

appropriate time, we will determine whether we will develop our own sales and marketing capabilities or enter into agreements

with third parties to sell our products.

We have limited experience in developing,

training or managing a sales force. If we choose to establish a direct sales force, we may incur substantial additional expenses

in developing, training and managing such an organization. We may be unable to build a sales force on a cost-effective basis or

at all. In addition, we will compete with many other companies that currently have extensive marketing and sales operations. Our

marketing and sales efforts may be unable to compete against these other companies. We may be unable to establish a sufficient

sales and marketing organization on a cost-effective or timely basis, if at all.

If we choose to enter into agreements with

third parties to sell our proposed products, we may be unable to establish or maintain third-party relationships on a commercially

reasonable basis, if at all. In addition, these third parties may have similar or more established relationships with our competitors.

We may be unable to engage qualified distributors.

Even if engaged, these distributors may:

· fail to adequately market our products;

· fail to satisfy financial or contractual obligations to us;

· offer, design, manufacture or promote competing products; or

· cease operations with little or no notice.

If we fail to develop sales, marketing

and distribution channels, we would experience delays in product sales and incur increased costs, which would have a material adverse

effect on our business, prospects, financial condition and results of operation.

If we are unable to convince physicians of

the benefits of our intended products, we may incur delays or additional expense in our attempt to establish market acceptance.

Achieving use of our products in the target

market of cancer diagnosis and treatment may require physicians to be informed regarding these products and their intended benefits.

The time and cost of such an educational process may be substantial. Inability to successfully carry out this physician education

process may adversely affect market acceptance of our proposed products. We may be unable to educate physicians, in sufficient

numbers, in a timely manner regarding our intended proposed products to achieve our marketing plans and product acceptance. Any

delay in physician education may materially delay or reduce demand for our proposed products. In addition, we may expend significant

funds towards physician education before any acceptance or demand for our proposed products is created, if at all.

If users of our products are unable to obtain

adequate reimbursement from third-party payors, or if additional healthcare reform measures are adopted, it could hinder or prevent

the commercial success of our product candidates.

The continuing efforts of government and

insurance companies, health maintenance organizations and other payors of healthcare costs to contain or reduce costs of healthcare

may adversely affect our ability to generate future revenues and achieve profitability, including by limiting the future revenues

and profitability of our potential customers, suppliers and collaborative partners. For example, in certain foreign markets pricing

or profitability of prescription pharmaceuticals are subject to government control. The U.S. government is implementing, and other

governments have shown significant interest in pursuing, healthcare reform. Any government-adopted reform measures could adversely

affect the pricing of healthcare products and services in the U.S. or internationally and the amount of reimbursement available

from governmental agencies or other third-party payors. The continuing efforts of the U.S. and foreign governments, insurance companies,

managed care organizations, and other payors of healthcare services to contain or reduce healthcare costs may adversely affect

our ability to set prices for our products, should we be successful in commercializing them, and this would negatively affect our

ability to generate revenues and achieve and maintain profitability.

New laws, regulations and judicial decisions,

or new interpretations of existing laws, regulations and decisions, that relate to healthcare availability, methods of delivery

or payment for healthcare products and services, or sales, marketing or pricing of healthcare products and services may also limit

our potential revenue and may require us to revise our research and development programs. The pricing and reimbursement environment

may change in the future and become more challenging for several reasons, including policies advanced by the current or future

executive administrations in the U.S., new healthcare legislation, or fiscal challenges faced by government health administration

authorities. Specifically, in both the U.S. and some foreign jurisdictions, there have been a number of legislative and regulatory

proposals to change the healthcare system in ways that could affect our ability to sell our products profitably. In the U.S., changes

in the federal healthcare policy were enacted in 2010 and are being implemented. Some reforms could result in reduced reimbursement

rates for our product candidates, which would adversely affect our business strategy, operations and financial results. Our ability

to commercialize our products will depend in part on the extent to which appropriate reimbursement levels for the cost of our products

and related treatment are obtained by governmental authorities, private health insurers, and other organizations such as health

maintenance organizations (“HMOs”). Third-party payors are increasingly challenging the prices charged for medical

drugs and services. Also, the trend toward managed healthcare in the U.S. and the concurrent growth of organizations such as HMOs

that could control or significantly influence the purchase of healthcare services and drugs, as well as legislative proposals to

reform healthcare or change government insurance programs, may all result in lower prices for or rejection of our drugs. The cost

containment measures that healthcare payors and providers are instituting, and the effect of any healthcare reform, could materially

harm our ability to operate profitably.

Risks Related to Internal Controls

Failure to maintain effective internal controls

could adversely affect our ability to meet our reporting requirements.

We are required to establish and maintain

appropriate internal controls over financial reporting. Rules adopted by the SEC pursuant to Section 404 of the Sarbanes-Oxley

Act of 2002 require an annual assessment of internal controls over financial reporting and for certain issuers an attestation of

this assessment by the issuer’s independent registered public accounting firm. The standards to assess that our internal

controls over financial reporting are effective are evolving and complex, require significant documentation and testing, and may

require remediation if they are not met. We expect to incur significant expenses and to devote resources to Section 404 compliance

on an ongoing basis. It is difficult for us to predict how long it will take or costly it will be to complete the assessment of

the effectiveness of our internal control over financial reporting for each year and to remediate any deficiencies in our internal

control over financial reporting. As a result, we may not be able to complete the assessment and remediation process on a timely

basis. In addition, although attestation requirements by our independent registered public accounting firm are not presently applicable

to us, we could become subject to these requirements in the future, and we may encounter problems or delays in completing the implementation

of any resulting changes to internal controls over financial reporting.

Effective internal controls are necessary

for us to provide reasonable assurance with respect to our financial reports and to effectively prevent fraud. Failure to maintain

effective internal controls could adversely affect our public disclosures regarding our business, prospects, financial condition

or results of operations. In addition, management’s assessment of internal controls over financial reporting may identify

weaknesses and conditions that need to be addressed in our internal controls over financial reporting or other matters that may

raise concerns for investors. Any actual or perceived weaknesses and conditions that need to be addressed in our internal control

over financial reporting or disclosure of management’s assessment of our internal controls over financial reporting our business

and results of operations could be harmed, we could fail to meet our reporting obligations, and there could be a material adverse

effect on our common stock price.

Risks Related to Our Equity Securities

Our stock price has experienced price fluctuations.

There can be no assurance that the market

price for our common stock will remain at its current level, and a decrease in the market price could result in substantial losses

for investors. The market price of our common stock may be significantly affected by one or more of the following factors:

· our ability to maintain our listing on the Nasdaq exchange.

Our common stock could be further diluted as

the result of the issuance of additional shares of common stock, convertible securities, warrants or options.

In the past, we have issued common stock,

convertible securities (such as convertible preferred stock and notes) and warrants in order to raise capital. We have also issued

equity as compensation for services and incentive compensation for our employees and directors. We have shares of common stock

reserved for issuance upon the exercise of certain of these securities and may increase the shares reserved for these purposes

in the future. Our issuance of additional common stock, convertible securities, options and warrants could dilute our common stock,

affect the rights of our stockholders, reduce the market price of our common stock, result in adjustments to exercise prices of

outstanding warrants (resulting in these securities becoming exercisable for, as the case may be, a greater number of shares of

our common stock), or obligate us to issue additional shares of common stock to certain of our stockholders.

Provisions of our certificate of incorporation,

by-laws, and Delaware law may make an acquisition of us or a change in our management more difficult.

Certain provisions of our certificate of

incorporation and by-laws could discourage, delay or prevent a merger, acquisition or other change in control that stockholders

may consider favorable, including transactions in which an investor might otherwise receive a premium for its shares. These provisions

also could limit the price that investors might be willing to pay in the future for shares of our common stock or warrants, thereby

depressing the market price of our common stock. Stockholders who wish to participate in these transactions may not have the opportunity

to do so.

Furthermore, these provisions could prevent

or frustrate attempts by our stockholders to replace or remove our management. These provisions:

· limit who may call stockholder meetings; and

In addition, because we are incorporated

in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which may, unless certain

criteria are met, prohibit large stockholders, in particular those owning 15% or more of our outstanding voting stock, from merging

or combining with us for a prescribed period of time.

Item 2. Properties.

We lease administrative office space in

Florham Park, New Jersey and Madison, Wisconsin. The space in New Jersey consists of approximately 4,000 square feet and is rented

for approximately $12,900 per month under an agreement that expires on February 29, 2024, subject to one five-year extension. The

space in Wisconsin consists of approximately 300 square feet and is rented for approximately $3,100 per month under an agreement

that expires on August 31, 2021.

Item 3. Legal Proceedings.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

PART II

MARKET FOR COMMON EQUITY

Market Information

Our common stock is listed on the NASDAQ

Capital Market under the ticker symbol CLRB.

On February 25, 2021 there were 181 holders

of record of our common stock. This number does not include stockholders for whom shares were held in a “nominee” or

“street” name.

We have not declared or paid any cash dividends

on our common stock and do not anticipate declaring or paying any cash dividends in the foreseeable future. We currently expect

to retain future earnings, if any, for the continued development of our business.

Our transfer agent and registrar is American

Stock Transfer and Trust Company, 6201 15th Avenue, Brooklyn, NY 11219.

Equity compensation plans

During 2015, we issued 3,750 options to

our Chief Executive Officer that were not issued pursuant to our 2015 Stock Incentive Plan. These options vested annually over

four years and expire ten years after the date of grant. During 2016, we issued 7,500 options to our Chief Business Officer that

were not issued pursuant to our 2015 Stock Incentive Plan. These options vested annually over three years and expire ten years

after the date of grant. During 2019, we issued 90,000 options to our Chief Financial Officer that were not issued pursuant to

our 2015 Stock Incentive Plan. During 2020, we issued 100,000 options to our Chief Medical Officer that were not issued pursuant

to our 2015 Stock Incentive Plan. These options vest annually over three years and expire ten years after the date of grant. For

all option issuances, the option price per share is not less than the fair market value of our common stock on the date of grant.

The following table provides information

as of December 31, 2020 regarding shares authorized for issuance under our equity compensation plans, including individual compensation

arrangements.

Equity compensation plan information

(a) (b) (c)

Equity compensation plans not approved by stockholders 201,250 $ 7.71 n/a

Item 6. Selected Financial Data.

Not applicable.

Overview

We are a late-stage clinical biopharmaceutical

company focused on the discovery, development and commercialization of drugs for the treatment of cancer. Our core objective is

to leverage our proprietary PDC delivery platform to develop PDCs that are designed to specifically target cancer cells and deliver

improved efficacy and better safety as a result of fewer off-target effects. Our PDC platform possesses the potential for

the discovery and development of the next generation of cancer-targeting treatments, and we plan to develop PDCs both independently

and through research and development collaborations.

Our lead PDC therapeutic, CLR 131 is

a small-molecule PDC designed to provide targeted delivery of iodine-131 directly to cancer cells, while limiting exposure to

healthy cells. We believe this profile differentiates CLR 131 from many traditional on-market treatments. CLR 131 is

CLRB US Equity

CLRB · 10-K · period ended 2020-12-31

Item 1A. Risk Factors.

Item 2. Properties.

Item 3. Legal Proceedings.

Item 4. Mine Safety Disclosures.

Item 6. Selected Financial Data.

CLRB US Equity☆

CLRB · 10-K · period ended 2020-12-31

Item 1A. Risk Factors.

Item 2. Properties.

Item 3. Legal Proceedings.

Item 4. Mine Safety Disclosures.

Item 6. Selected Financial Data.

CLRB US Equity