ITEM 1.	IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS	4
ITEM 2.	OFFER STATISTICS AND EXPECTED TIMETABLE	4
ITEM 3.	KEY INFORMATION	4
ITEM 4.	INFORMATION ON THE COMPANY	90
ITEM 4A.	UNRESOLVED STAFF COMMENTS	172
ITEM 5.	OPERATING AND FINANCIAL REVIEW AND PROSPECTS	173
ITEM 6.	DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES	195
ITEM 7.	MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS	211
ITEM 8.	FINANCIAL INFORMATION	213
ITEM 9.	THE OFFER AND LISTING	215
ITEM 10.	ADDITIONAL INFORMATION	215
ITEM 11.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	222
ITEM 12.	DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES	224
ITEM 13.	DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES	227
ITEM 14.	MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	227
ITEM 15.	CONTROLS AND PROCEDURES	227
ITEM 16.	RESERVED	228
ITEM 16A.	AUDIT COMMITTEE FINANCIAL EXPERT	228
ITEM 16B.	CODE OF ETHICS	228
ITEM 16C.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	228
ITEM 16D.	EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	229
ITEM 16E.	PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	229
ITEM 16F.	CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT	229
ITEM 16G.	CORPORATE GOVERNANCE	229
ITEM 16H.	MINE SAFETY DISCLOSURE	230
ITEM 16I.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	230
ITEM 16J.	INSIDER TRADING POLICIES	230
ITEM 16K.	CYBERSECURITY	231
ITEM 17.	FINANCIAL STATEMENTS	233
ITEM 18.	FINANCIAL STATEMENTS	233
ITEM 19.	EXHIBITS	233

•	the ongoing commercialization of Illuccix® and our preparation for the commercialization of our products and product candidates, if or when they are approved;

•	the timing and review of submissions for regulatory approval of our product candidates, including review of our accepted submissions for Gozellix® (TLX007-CDx) and Pixclara® (TLX101-CDx), our resubmission for Zircaix® (TLX250-CDx), and our ability to obtain and maintain such regulatory approvals;

•	the initiation, timing, progress and results of our ongoing and planned clinical trials, including the timing of dosing of patients, enrollment and completion of these trials, including multi-national trials, and the anticipated results from these trials;

•	our sales, marketing and distribution capabilities and strategies, including for the commercialization and manufacturing of Illuccix and any future products;

•	our ability to obtain an adequate supply at reasonable costs of raw materials we may incorporate into our products and product candidates;

•	our ability to address the fulfillment and logistical challenges posed by the time-limited stabilization of our products and product candidates;

•	our commercialization, marketing and manufacturing capabilities and strategy, including the timing and costs of expanding our manufacturing capabilities;

•	the rate and degree of market acceptance and clinical utility of our products and product candidates;

•	the pricing and reimbursement of our products and product candidates, if and after they have been approved;

•	estimates of our expenses, future revenues and capital requirements;

•	our financial performance;

•	developments relating to our competitors and industry;

•	the success of our collaborations and partnerships with third parties;

•	our ability to maintain, expand, protect and enforce our regulatory exclusivity and intellectual property, or IP, portfolio;

•	our expectations regarding our ability to obtain and maintain regulatory exclusivity and intellectual property protection for our products and product candidates;

•	our ability to successfully integrate the businesses that we have acquired or may acquire in the future;

•	our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

•	legal and regulatory developments in the United States, Australia and other jurisdictions;

•	our ability to remain compliant with the respective listing rules and standards of the Australian Securities Exchange, or ASX, Singapore Exchange Securities Trading Limited, or SGX, and the Nasdaq Global Select Market, or Nasdaq;

•	our ability to attract and retain key scientific or management personnel;

•	the success of competing therapies that are or may become available;

•	our expectations regarding the period during which we qualify as an emerging growth company, or EGC, under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act;

•	the volatility of currency exchange rates;

•	the impact of and changes in governmental regulations or the enforcement thereof, tax laws and rates, accounting guidance and similar matters in regions in which we operate or will operate in the future; and

•	other risks and uncertainties, including those listed under “Item 3. Key Information — D. Risk Factors.”

•

We have a history of significant net losses, our operating expenses may increase in the future, and we may not be able to maintain profitability in future periods.

•

We may need to raise capital to achieve our business objectives if we are unable to fund our operations with our cash flows from the sale of our products. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs and/or commercialization efforts.

•

We may not be able to effectively integrate the businesses that we have acquired and/or may acquire in the future.

•

Our business is substantially dependent on the commercial success of Illuccix and our product candidates. If we are unable to successfully commercialize Illuccix as currently approved or to successfully commercialize our product candidates, our business, financial condition and results of operations will be materially harmed.

•

Clinical development is a lengthy and expensive process, with uncertain timelines and outcomes. If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of such product candidates.

•

If we experience delays or difficulties in enrolling patients in our ongoing or planned clinical trials, our receipt of necessary regulatory approval could be delayed or prevented.

•

The results of previous clinical trials may not be predictive of future trial results, and preliminary, interim or top-line data may be subject to change or qualification based on the complete analyses of data and, therefore, may not be predictive of the final results of a trial.

•

Due to their radioactive nature, Illuccix and our product candidates have time-limited stability, and as a result, we may encounter difficulties with fulfillment and logistics.

•

We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do.

•

The commercial success of Illuccix and our product candidates, if approved, will depend upon public perception of radiopharmaceuticals and the degree of their market acceptance by physicians, patients, healthcare payors and others in the medical community.

•

We may be unable to generate and/or obtain a sufficient supply of radioisotopes to support clinical development or manufacturing at commercial scale.

•

Even if we are able to effectively commercialize Illuccix or any product candidates for which we obtain approval, the products may not receive coverage or may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, all of which would harm our business.

•

We depend on collaborations with third parties for certain aspects of the development, marketing and/or commercialization of Illuccix and our product candidates. If those collaborations are not successful, or if we are not able to maintain our existing collaborations or establish additional collaborations, we may have to alter our development and commercialization plans and may not be able to capitalize on the market potential of Illuccix or our product candidates.

•

If we are unable to obtain and/or maintain commercially valuable regulatory exclusivity and patent claims or to protect our patents, trademarks, know-how and trade secrets, our ability to successfully commercialize our products and product candidates would be adversely impacted.

•

An active and liquid market for our securities may not continue to be developed or sustained, which could harm the market price of the ADSs.

•

As a foreign private issuer, we are permitted to follow certain home country corporate governance practices in lieu of certain Nasdaq requirements applicable to domestic issuers.

•

We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our ADSs.

•

effectively commercializing Illuccix or any future products either on our own or with a collaborator, including by maintaining a full commercial organization required to market, sell and distribute our products, and achieving an adequate level of market acceptance;

•

the impact of current or future competing products on product sales of Illuccix or any of our future products;

•

obtaining sufficient pricing, coverage and reimbursement, under U.S. federal healthcare programs, such as Medicare and Medicaid, and from private payors, for Illuccix and any of our other approved products from private and government payors and the impact of any pricing changes;

•

initiating and successfully completing clinical trials required to file for, obtain and maintain regulatory approval for our product candidates;

•

obtaining and maintaining regulatory approvals, and the timing of such approvals;

•

manufacturing at commercial scale;

•

establishing and managing any collaborations for the development, marketing and/or commercialization of our products and product candidates, including the level of success of any such collaborators’ efforts and the timing and amount of any milestone or royalty payments we may receive; and

•

obtaining, maintaining and protecting our intellectual property rights.

•

commercialize Illuccix in the United States, Australia, New Zealand, Canada, Europe and other jurisdictions following regulatory approval, including maintaining our commercial infrastructure;

•

obtain and/or maintain regulatory approval for Illuccix and our product candidates, including completing any required post-marketing requirements to the satisfaction of the FDA or other regulatory agencies;

•

expand our research and development programs, identify additional product candidates and initiate and conduct clinical trials, including clinical trials required by the FDA or other regulatory agencies in addition to those that have been or are currently expected to be conducted;

•

maintain, expand and protect our intellectual property portfolio;

•

manufacture Illuccix and our product candidates;

•

add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future radiopharmaceutical commercialization efforts;

•

operate as a publicly listed company in the United States and Australia; and

•

acquire or in-license other products, product candidates or technologies.

•

the scope, progress, results, timing and costs of our current and planned development efforts and regulatory review of our product candidates;

•

the amount and timing of revenues from sales of Illuccix or any product candidate for which we receive regulatory approval;

•

the cost of, and our ability to expand and maintain, the commercial infrastructure required to support the commercialization of Illuccix and any other product for which we receive regulatory approval, including medical affairs, manufacturing, marketing and distribution functions;

•

our ability to establish and maintain collaboration, partnership, licensing, marketing, distribution or other arrangements on favorable terms and the level and timing of success of these arrangements;

•

the extent to which we acquire or in-license other products, product candidates and technologies; and

•

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims.

•

timing and variations in the level of expense related to the current or future development of our programs;

•

timing and status of enrollment for our clinical trials;

•

results of clinical trials, or the addition or termination of clinical trials or funding support by us or potential future partners;

•

timing of any milestone payments or other payment obligations to be paid by us pursuant to existing supply agreements, licenses or collaborations;

•

timing of any milestone payments or other payments to be received by us pursuant to our license agreement;

•

our execution of any collaboration, licensing or similar arrangements, and the timing of payments we may make or receive under potential future arrangements or the termination or modification of any such potential future arrangements;

•

any intellectual property infringement, misappropriation or violation lawsuit or opposition, interference or cancellation proceeding in which we may become involved;

•

additions and departures of key personnel;

•

strategic decisions, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;

•

if any product candidate we may develop receives regulatory approval, the timing and terms of such approval and market acceptance and demand for such product candidate;

•

the timing and cost to establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain regulatory approval and intend to commercialize on our own or jointly with current or future collaborators;

•

regulatory developments affecting Illuccix or any other of our product candidates or those of our competitors; and

•

changes in general market and economic conditions, including as a result of the ongoing war between Russia and Ukraine and other current or future conflicts that may arise.

•

increasing our vulnerability to adverse economic and industry conditions;

•

limiting our ability to obtain additional financing;

•

requiring the dedication of a portion of our cash flow from operations to service our indebtedness, which would reduce the amount of cash available for other purposes;

•

limiting our flexibility to plan for, or react to, changes in our business;

•

diluting the interests of our existing shareholders as a result of issuing ordinary shares upon conversion of the Convertible Bonds; and

•

placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital.

•

increased operating expenses and cash requirements;

•

the assumption of indebtedness or contingent liabilities;

•

the issuance of our equity securities which would result in dilution to our shareholders and ADS holders;

•

assimilation of operations, intellectual property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel;

•

the diversion of our management’s attention from our existing product programs and initiatives in pursuing such an acquisition or strategic partnership;

•

retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;

•

risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and

•

our inability to generate revenue from acquired intellectual property, technology and/or products sufficient to meet our objectives or even to offset the associated transaction and maintenance costs.

•

the inability to integrate effectively the operations, products, technologies and personnel of the acquired companies (some of which are in diverse geographic regions) and achieve expected synergies;

•

the potential disruption of existing business and diversion of management’s attention from day-to-day operations;

•

the inability to maintain uniform standards, controls, procedures and policies;

•

the need or obligation to divest portions of the acquired companies to satisfy regulatory requirements;

•

the potential failure to identify material problems and liabilities during due diligence review of acquisition targets;

•

the potential failure to obtain sufficient indemnification rights to fully offset possible liabilities associated with acquired businesses; and

•

the challenges associated with operating in new product segments and/or geographic regions.

•

diversion of financial and managerial resources from existing operations;

•

successfully negotiating a proposed acquisition, in-license or investment in a timely manner and at a price or on terms and conditions favorable to us;

•

successfully combining and integrating a potential acquisition into our existing business to fully realize the benefits of such acquisition;

•

the impact of regulatory reviews on a proposed acquisition, in-license or investment; and

•

the outcome of any legal proceedings that may be instituted with respect to the proposed acquisition, in-license or investment.

•

delays or failure to reach agreement with regulatory authorities on a trial design or the receipt of feedback requiring us to modify the design of our clinical trials, perform additional or unanticipated clinical trials to obtain approval or alter our regulatory strategy;

•

clinical trials of our product candidates may produce negative or inconclusive results or other patient safety concerns, including undesirable side effects or other unexpected characteristics, and we may decide, or regulatory authorities may require us, to conduct additional clinical trials, suspend ongoing clinical trials or abandon product development programs, including as a result of a finding that the participants are being exposed to unacceptable health risks;

•

enrollment in our clinical trials may be slower than we anticipate or we may not be able to enroll the number of patients that we expect, including as a result of competition with other ongoing clinical trials for the same indications as our product candidates or because the patient population may be limited for orphan indications;

•

regulators may revise the requirements for approving our product candidates, even after providing a positive opinion on or otherwise reviewing and providing comments on a clinical trial protocol, or such requirements may not be as we anticipate;

•

delays or failure in obtaining the necessary authorization from regulatory authorities or institutional review boards to permit us or our investigators to commence a clinical trial, conduct a clinical trial at a prospective trial site, or the suspension or termination of a clinical trial once commenced;

•

delays or failure to reach agreement on acceptable terms with prospective clinical trial sites or contract research organizations, or CROs;

•

delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing;

•

the number of patients required for clinical trials of our product candidates may be larger than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;

•

our third-party contractors, including manufacturers or CROs, may fail to comply with regulatory requirements, perform effectively, or meet their contractual obligations to us in a timely manner, or at all;

•

we or our investigators might be found to be non-compliant with regulatory requirements;

•

the cost of clinical trials of our product candidates may be greater than we anticipate;

•

the supply or quality of our product candidates or other materials necessary to conduct clinical trials may be insufficient or inadequate;

•

regulators or institutional review boards/ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

•

imposition of a temporary or permanent clinical hold by regulatory authorities for a number of reasons, including after review of an IND or amendment or equivalent foreign application or amendment, as a result of a new safety finding that presents unreasonable risk to clinical trial participants, or a negative finding from an inspection of our clinical trial operations or study sites;

•

developments on trials conducted by competitors for related technology that raises FDA or foreign regulatory authority concerns about risk to patients of the technology broadly, or if the FDA or a foreign regulatory authority finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;

•

occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits, or occurrence of adverse events in trial of the same class of agents conducted by other companies;

•

any partners or collaborators that help us conduct clinical trials may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us; and

•

negative impacts resulting from infectious disease epidemics or pandemics, including impacts to healthcare systems and our trial sites’ ability to conduct trials.

•

be delayed in obtaining, or not obtain at all, regulatory approval for the indication or product candidate;

•

obtain regulatory approval in some countries and not in others;

•

obtain approval for indications or patient populations that are not as broad as intended or desired;

•

obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

•

be subject to additional post-marketing testing requirements; or

•

have the product removed from the market after obtaining regulatory approval.

•

severity of the disease under investigation;

•

our ability to recruit clinical trial investigators of appropriate competencies and experience;

•

the incidence and prevalence of our target indications;

•

clinicians’ and patients’ awareness of, and perceptions as to the potential advantages and risks of our product candidates in relation to other available therapies, including any new products that may be approved for the indications we are investigating;

•

invasive procedures required to enroll patients and to obtain evidence of the product candidate’s performance during the clinical trial;

•

availability and efficacy of approved medications for the disease under investigation;

•

eligibility criteria defined in the protocol for the trial in question;

•

the ability of our companion diagnostics to identify patients;

•

the size of the patient population required for analysis of the trial’s primary endpoints;

•

efforts to facilitate timely enrollment in clinical trials;

•

whether we are subject to a partial or full clinical hold on any of our clinical trials;

•

reluctance of physicians to encourage patient participation in clinical trials;

•

the ability to monitor patients adequately during and after treatment;

•

our ability to obtain and maintain patient consents; and

•

proximity and availability of clinical trial sites for prospective patients.

•

regulatory authorities may withdraw the approval of such product;

•

regulatory authorities may require additional warnings on the label, such as a “black box” warning, precaution or a contraindication, or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product, or impose distribution or use restrictions;

•

patients and/or healthcare providers may elect to utilize other treatment options that have or are perceived to have more tolerable side effects;

•

regulatory authorities may require one or more post-marketing studies;

•

we may be required to implement a Risk Evaluation and Mitigation Strategy, or REMS, or create a medication guide outlining the risks of such side effects for distribution to patients;

•

additional restrictions may be imposed on the marketing or promotion of the particular product or the manufacturing processes for the product or any component thereof;

•

we could be sued and held liable for harm caused to patients;

•

the product could become less competitive; and

•

our reputation may suffer.

•

obtaining regulatory authorizations to commence a trial or reaching a consensus with regulatory authorities on trial design;

•

the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical studies;

•

any failure or delay in reaching an agreement with CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•

obtaining approval from one or more institutional review boards, or IRBs;

•

IRBs or ethics committees refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;

•

changes to the clinical trial protocol;

•

delays in identifying, recruiting and training suitable clinical investigators;

•

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

•

manufacturing sufficient quantities of our product candidates for use in clinical trials;

•

subjects failing to enroll or remain in our trials at the rate we expect, or failing to return for post-treatment follow-up, including subjects failing to remain in our trials due to movement restrictions, health reasons or otherwise resulting from ongoing or future public health or geopolitical concerns;

•

subjects choosing alternative treatments for the indications for which we are developing our therapeutic product candidates, or participating in competing clinical trials;

•

lack of adequate funding to continue the clinical trial or incurring greater costs than we anticipate;

•

subjects experiencing severe or serious unexpected drug-related adverse effects;

•

occurrence of serious adverse events in trials of the same class of agents conducted by other companies;

•

selection of clinical endpoints that require prolonged periods of clinical observation or extended analysis of the resulting data;

•

failure of a facility manufacturing our product candidates or any of their components to produce clinical trial materials in accordance with current good manufacturing practice requirements, or cGMP, regulations (and similar foreign requirements) or other applicable requirements;

•

a facility manufacturing our product candidates or any of their components being ordered by the FDA or comparable foreign regulatory authorities to temporarily or permanently shut down due to violations of cGMP regulations (and similar foreign requirements) or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process;

•

any transfer of manufacturing processes to alternate facilities or any other changes to our manufacturing process that may be necessary or desired;

•

third-party clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, good clinical practice, or GCP, requirements or other regulatory requirements;

•

third-party contractors not performing data collection or analysis in a timely or accurate manner; or

•

third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications.

•

the research methodology used may not be successful in identifying potential product candidates;

•

potential product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that will receive regulatory approval and/or achieve market acceptance; or

•

potential product candidates may not be effective in treating their targeted diseases or yield clinically significant outcomes.

•

our ability to successfully launch and achieve broad adoption of Illuccix or any other product for which we obtain approval, or any future indications for which Illuccix may be approved;

•

the competitive landscape for Illuccix and our product candidates, including the timing of new competing products entering the market and the level and speed at which these products achieve market acceptance;

•

actual or perceived advantages or disadvantages of Illuccix or any product candidates for which we obtain approval as compared to alternative treatments, including their respective safety, tolerability and efficacy profiles, the potential convenience and ease of administration, access or cost effectiveness;

•

the effectiveness of our sales, marketing, manufacturing and distribution strategies and operations;

•

the consistency of any new data we collect and analyses we conduct with prior results; whether they support a favorable safety, efficacy and effectiveness profile of Illuccix; and any potential impact on our FDA or any foreign regulatory approvals and/or labeling for Illuccix;

•

our ability to comply with the FDA’s and comparable foreign regulatory authorities’ post-marketing requirements and commitments, including through successfully conducting, on a timely basis, additional studies that confirm clinical efficacy, effectiveness and safety of Illuccix (or any product candidates for which we obtain approval and are required to conduct such studies) and acceptance of the same by the FDA or similar foreign regulatory authorities;

•

acceptance of current indications of Illuccix and future indications of Illuccix and other product candidates, if approved, by patients, the medical community and third-party payors;

•

obtaining and maintaining coverage, adequate pricing and reimbursement by third-party payors, including government payors, for Illuccix and our product candidates, if approved;

•

the willingness of patients to pay out-of-pocket in the absence of third-party coverage or as co-pay amounts under third-party coverage;

•

our ability to enforce intellectual property rights in and to our products to prohibit a third party from marketing a competing product and our ability to avoid third-party patent interference or intellectual property infringement claims;

•

current and future restrictions or limitations on our approved or future indications and patient populations or other adverse regulatory actions;

•

the performance of our manufacturers, license partners, distributors, providers and other business partners, over which we have limited control;

•

any significant misestimations of the size of the market and market potential for any of Illuccix or our product candidates;

•

establishing and maintaining commercial manufacturing capabilities or making arrangements with third-party manufacturers;

•

the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies, based, in part, on their perception of our clinical trial data and/or the actual or perceived safety, tolerability and effectiveness profile;

•

maintaining an acceptable safety and tolerability profile of Illuccix or any of our product candidates for which we obtain approval, including the prevalence and severity of any side effects;

•

the ability to offer Illuccix or any product candidates for which we obtain approval for sale at competitive prices;

•

adverse publicity about our products or favorable publicity about competitive products; and

•

our ability to maintain compliance with existing and new health care laws and regulations, including government pricing, price reporting and other disclosure requirements related to such laws and regulations, and the potential impact of such laws and regulations on physician prescribing practices and payor coverage.

•

our inability to recruit, train and retain adequate numbers of effective sales, market access, market analytics, operations and marketing personnel;

•

the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe current or future products;

•

the lack of complementary products, which may put us at a competitive disadvantage relative to companies with more extensive product lines;

•

unforeseen costs and expenses associated with creating an independent sales, marketing and distribution organization;

•

our inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies;

•

our ability to supply, manufacture and deliver sufficient inventory of our products for commercial sale on a timely basis; and

•

existing or new competitors taking share from Illuccix or any other product candidate for which we obtain approval in the future, or preventing Illuccix or any such product from gaining share in its approved indications.

•

our ability to provide acceptable evidence of safety and efficacy;

•

the prevalence and severity of any side effects in general, and differentiation relative to other treatments;

•

limitations or warnings contained in the labeling approved for our product candidates by the FDA;

•

the size of the target patient population;

•

advertising concerning our products or competing products and treatments;

•

availability, relative cost and relative efficacy of alternative and competing treatments;

•

the ability to offer our products for sale at competitive prices;

•

the relative convenience and ease of administration of our products and product candidates, which may require coordination amongst multiple physicians across disciplines for administration;

•

the willingness of the target patient population to try new products or product candidates and of physicians to prescribe these products and product candidates;

•

strength of marketing and distribution support;

•

publicity for our product candidates and competing products and treatments;

•

the existence of distribution and/or use restrictions, such as through a REMS;

•

the availability of third-party payor coverage and adequate reimbursement;

•

the timing of any marketing approval in relation to other product approvals;

•

support from patient advocacy groups;

•

any restrictions on the use of our products together with other medications; and

•

the sufficiency of coverage or reimbursement by third parties.

•

decreased demand for Illuccix and any other products that we may develop or acquire;

•

injury to our reputation and significant negative media attention;

•

withdrawal of clinical trial participants;

•

initiation of investigations by regulators;

•

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

•

significant costs to defend the related litigation;

•

substantial monetary awards to trial participants or patients;

•

loss of revenue;

•

reduced resources of our management to pursue our business strategy; and

•

the inability to successfully commercialize Illuccix and any other products that we may develop or acquire.

•

regulatory authorities may determine that our product candidates do not demonstrate safety and effectiveness in accordance with regulatory agency standards based on a number of considerations, including adverse events that are reported during clinical trials;

•

regulatory authorities could analyze and/or interpret data from clinical trials and preclinical testing in different ways than we interpret them and determine that our data is insufficient for approval;

•

regulatory authorities may require more information, including additional preclinical or clinical data or the conduct of new trials, to support approval;

•

regulatory authorities could determine that our manufacturing processes are not properly designed, are not conducted in accordance with federal or other laws or otherwise not properly managed, and we may be unable  to obtain regulatory approval for a commercially viable manufacturing process for our product candidates in a timely manner, or at all;

•

the supply or quality of our product candidates for our clinical trials may be insufficient, inadequate or delayed;

•

the size of the patient population required to establish the efficacy of our product candidates to the satisfaction of regulatory agencies may be larger than we or they anticipated;

•

our failure or the failure of clinical sites, and the records kept at the respective locations, including records containing clinical trial data, to be in compliance with the FDA’s GCP, requirements or comparable regulations outside of the United States;

•

regulatory authorities may change their approval policies or adopt new regulations;

•

regulatory authorities may not be able to undertake reviews of our marketing applications, conduct applicable inspections or proceed through their approval processes in a timely manner;

•

the results of our earlier clinical trials may not be representative of our future, larger trials;

•

regulatory authorities may not agree with our regulatory approval strategies or components of our or their regulatory filings, such as the design or implementation of the relevant clinical trials; or

•

a product may not be approved for the indications that we request or may be limited or subject to restrictions or post-approval commitments that render the approved drug not commercially viable.

•

additional foreign regulatory requirements;

•

foreign exchange fluctuations;

•

compliance with foreign manufacturing, customs, shipment and storage requirements;

•

cultural differences in medical practice and clinical research;

•

diminished protection of intellectual property in some countries; and

•

interruptions or delays in our trials resulting from geopolitical events, such as war or terrorism.

•

the federal healthcare Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order, arranging for or recommendation of, any good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation;

•

the FCA imposes criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting or causing to be presented, to the federal government, claims for payment or approval from Medicare, Medicaid or other government payors that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government, with potential liability including mandatory treble damages and significant per-claim penalties. 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 FCA;

•

the federal false statements statute, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or service. Similar to the federal Anti-Kickback Statute, 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;

•

the federal transparency requirements under the federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies to report to the HHS, information related to payments and other transfers of value to physicians (as defined by statute), other healthcare providers and teaching hospitals and ownership and investment interests held by physicians and their immediate family members and applicable group purchasing organizations;

•

analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, and certain 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 in addition to requiring drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures; and

•

international, federal or state laws, regulations, or rules that oversee the compounding, administration or distribution of radiopharmaceutical products by licensed pharmacists.

•

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

•

collaborators may not perform their obligations as expected or in compliance with applicable local and national laws and regulatory requirements;

•

collaborators may de-emphasize or may not pursue development, marketing and/or commercialization of our products or product candidates or may elect not to continue or renew development, marketing or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus, including as a result of a sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities;

•

collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or 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 our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

•

a collaborator with marketing and distribution rights to one or more products or product candidates may not commit sufficient resources to the marketing and distribution of our products or product candidates;

•

disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development or commercialization, might cause delays or termination of the research, development or commercialization of products or product candidates, might lead to additional responsibilities for us with respect to our products or product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

•

collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

•

collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

•

we may lose certain valuable rights under circumstances identified in any collaboration arrangement that we enter into, such as if we undergo a change of control;

•

collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development, marketing and/or commercialization of the applicable products or product candidates or to enter into new collaboration agreements;

•

collaborators may learn about our discoveries and use this knowledge to compete with us in the future;

•

collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all; and

•

the number and type of our collaborations could adversely affect our attractiveness to other collaborators or acquirers.

•

not provide us accurate or timely information regarding their inventories, the number of patients who are using Illuccix or serious adverse reactions, events and/or product complaints regarding Illuccix;

•

not effectively sell or support Illuccix or communicate publicly concerning Illuccix in a manner that is contrary to FDA rules and regulations;

•

reduce their efforts or discontinue to sell or support, or otherwise not effectively sell or support, Illuccix;

•

not devote the resources necessary to sell Illuccix in the volumes and within the time frames that we expect;

•

be unable to satisfy financial obligations to us or others;

•

not be able to obtain or maintain all necessary licenses; or

•

cease operations.

•

reliance on the third party for regulatory compliance and quality assurance;

•

the possible breach, termination or nonrenewal of a manufacturing agreement by the third party, including at a time that is costly or inconvenient to us;

•

the possible failure of the third party to manufacture Illuccix or our product candidates according to our schedule, or at all, including if the third-party manufacturer gives greater priority to the supply of other products over Illuccix or our product candidates, or otherwise does not satisfactorily perform according to the terms of the manufacturing agreement;

•

equipment malfunctions, power outages or other general disruptions experienced by our third-party manufacturers or distributors to their respective operations and other general problems with a multi-step manufacturing or distribution process;

•

the possible disruptions to supply chain and logistics processes that are required to store, transport, and deliver our products to customers that require timely delivery given the need to inject a dose of our products within a specific window of radioactivity; and

•

the possible misappropriation or disclosure by the third party or others of our proprietary information, including our trade secrets and know-how.

•

we may not be able to enter into critical strategic collaborations or enter into them on favorable terms;

•

collaborators may have significant discretion in determining the efforts and resources that they will apply to collaborations, and they may not perform their obligations as agreed, expected, or in compliance with applicable legal requirements;

•

collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to their acquisition of competitive products or their internal development 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 program, 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 our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than our product candidates;

•

a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;

•

we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;

•

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

•

disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our current or future product candidates or that results in costly litigation or arbitration that diverts management attention and resources;

•

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

•

collaborators may own or co-own intellectual property covering products that result from our collaboration with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property;

•

disputes may arise with respect to the ownership of any intellectual property developed pursuant to our collaborations; and

•

a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.

•

lodged regulatory filings may not result in intended market or data exclusivity;

•

governments may change data and market exclusivity provisions;

•

know-how and trade secrets may be published removing protections;

•

patent or trademark applications may not result in issued patents or trademarks or may take longer than expected to be issued;

•

the claims of any patents or trademarks that are issued may not provide meaningful protection;

•

patent term extensions may not be granted or, if granted, may be subject to revision;

•

we and our research partners may not be able to develop additional proprietary technologies that are patentable or otherwise protectable under regulatory exclusivity principles;

•

patents issued to us, or our industry partners, may not provide a competitive advantage;

•

other companies may challenge our issued patents or trademarks;

•

other companies may independently develop similar or alternative technologies to ours or duplicate or design around our technology;

•

other companies may hold patents or trademarks that are relevant to our technology or activities and enforce their rights against us; and

•

if patents are not issued, then the value of our patent rights may be significantly diminished.