Viking Therapeutics, Inc

International and currency · International operations and emerging markets

We are subject to economic, political, regulatory and other risks associated with international operations. One of our subsidiaries is located in Ireland and another is located in Australia and we may further expand our international operations.

Credit and liquidity · Access to capital and financing

Given our lack of current cash inflows, it is expected that we may need to raise additional capital; however, it may be unavailable to us or, even if capital is obtained, may cause dilution or place significant restrictions on our ability to operate our business.

Market and investment · Market volatility and economic cycles

The market price of our common stock may be highly volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, including adverse results or delays in clinical trials and inability to obtain additional funding.

Industry regulation · Regulatory compliance and changes

Our drug candidates are subject to extensive regulation under the FDA, EMA or comparable foreign authorities, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals to commercialize our drug candidates.

Legal and litigation · Litigation and legal proceedings

Any claims or lawsuits relating to infringement of intellectual property rights brought by or against us will be costly and time consuming and may adversely affect our business, financial condition and results of operations. In December 2022, we filed suit against Ascletis Defendants alleging violations of the Defend Trade Secrets Act.

Data and privacy · Cross border data transfer regulations

The GDPR also imposes strict rules on the transfer of personal data to countries outside the EU, which includes the United States and increases the scrutiny that clinical trial sites located in the EEA should apply to transfers of personal data from such sites to countries that are considered to lack an adequate level of data protection.

Legal and litigation · Product liability and warranty claims

We are exposed to product liability, non-clinical and clinical liability risks which could place a substantial financial burden upon us, should lawsuits be filed against us. A successful liability claim or series of claims brought against us could have a material adverse effect on our business, financial condition and results of operations.

Data and privacy · Regulatory investigations and penalties

We are subject to 'fraud and abuse' and similar laws and regulations, and a failure to comply with such regulations or prevail in any litigation related to noncompliance could harm our business, financial condition and results of operations.

Innovation and product development · Intellectual property protection and infringement

We are substantially dependent on technologies we licensed from Ligand, and if we lose the license to such technologies or our master license agreement with Ligand, or the Master License Agreement, is terminated for any reason, our ability to develop existing and new drug candidates would be harmed, and our business, financial condition and results of operations would be materially and adversely affected.

Innovation and product development · Clinical trial and regulatory approval risks

We are dependent on the success of one or more of our current drug candidates and we cannot be certain that any of them will receive regulatory approval or be commercialized. To date, no pivotal clinical trials designed to provide clinically and statistically significant proof of efficacy, or to provide sufficient evidence of safety to justify approval, have been completed with any of our drug candidates.

Customer and revenue · Changing customer preferences and behavior

The commercial success of our drug candidates depends upon their market acceptance among physicians, patients, healthcare payors and the medical community. The degree of market acceptance of any of our approved drug candidates will depend on a number of factors, including the effectiveness of our approved drug candidates as compared to currently available products.

Innovation and product development · Product development and randd investment risks

If development of our drug candidates does not produce favorable results, we and our collaborators, if any, may be unable to commercialize these products. The development process is expensive, can take many years and has an uncertain outcome. Failure can occur at any stage of the process.

Economic and market conditions · Economic recession and downturns

Unstable market and economic conditions may have serious adverse consequences on our business and financial condition. A severe or prolonged economic downturn could result in a variety of risks to our business, including our ability to raise additional capital when needed on acceptable terms, if at all.

Natural and catastrophic events · Natural disasters and extreme weather

Business disruptions such as natural disasters could seriously harm our future revenues and financial condition and increase our costs and expenses. Our corporate headquarters are located in greater San Diego, California, a region known for seismic activity.

Technology infrastructure · Technology systems and infrastructure failure

System failures, accidents or security breaches could cause interruptions in our operations or the operations of our CROs and other business partners, and could result in a material disruption of our drug development and clinical activities and business operations.

Cybersecurity and data protection · Data breaches and cyber attacks

We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively. Despite the implementation of security measures, our internal computer systems and those of third parties with which we contract are vulnerable to damage from cyber-attacks, computer viruses, unauthorized access.

Supply chain and procurement · Raw material availability and cost volatility

There are a limited number of suppliers for raw materials that we use to manufacture our drugs, and there may be a need to identify alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce our drug candidates.

Human capital and workforce · Talent acquisition and retention

Competition for qualified personnel is intense, especially in the greater San Diego, California area where we have a substantial presence and need for highly skilled personnel. We may not be successful in attracting qualified personnel to fulfill our current or future needs.

Reputation and brand · Brand damage and negative publicity

Undesirable side effects observed in clinical trials or in supportive preclinical studies with our drug candidates could interrupt, delay or halt their development. Such findings could result in the denial of regulatory approval or adversely affect the marketability of any drug candidates that receive regulatory approval.

Corporate governance · Internal controls and risk management

Our internal control over financial reporting may not meet the standards required by Section 404 of the Sarbanes-Oxley Act, and failure to achieve and maintain effective internal control over financial reporting could have a material adverse effect on our business and share price.