||compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;|
||workforce uncertainty in countries where labor unrest is more common than in the United States;|
||difficulties associated with staffing and managing international operations, including differing labor relations;|
||production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and|
||business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.|
We have no history of commercializing pharmaceutical
products, which may make it difficult to evaluate the prospects for our future viability.
We began our operations in 2003. Our operations
to date have been limited to financing and staffing our company, developing our technology and developing our product candidates
as well as early stage clinical trials. We have not yet demonstrated an ability to successfully complete a large-scale, pivotal
clinical study, obtain marketing approval, manufacture a commercial scale product or conduct sales and marketing activities necessary
for successful product commercialization. Consequently, predictions about our future success or viability may not be as accurate
as they could be if we had a history of successfully developing and commercializing pharmaceutical products.
Our future growth and ability to compete depends
on retaining our key personnel and recruiting additional qualified personnel.
Our success depends upon the continued
contributions of our key management, scientific and technical personnel, many of whom have substantial experience with or been
instrumental for us and our projects. Members of our key management include Dr. Andrea Pfeifer, our Chief Executive Officer;
Dr. Marie Kosco-Vilbois, our Chief Scientific Officer (who joined our team on January 3, 2019); Dr. Sonia Poli, our Head of Translational
Science; Piergiorgio Donati, our Head of Technical Operations and Program Management; Dr. Olivier Sol, our Head of Clinical
Team; Joerg Hornstein, our Chief Financial Officer; and Jean-Fabien Monin, our Chief Administrative Officer.
The loss of our key managers and senior
scientists could delay our research and development activities. Laws and regulations on executive compensation, including legislation
in our home country, Switzerland, may restrict our ability to attract, motivate and retain the required level of qualified personnel.
In Switzerland, legislation affecting public companies has been passed that, among other things, (i) imposes an annual binding
shareholders’ “say on pay” vote with respect to the compensation of executive management, including executive
officers and the board of directors; (ii) prohibits severance, advances, transaction premiums and similar payments to executive
officers and directors; and (iii) requires companies to specify various compensation-related matters in their articles of
association, thus requiring them to be approved by a shareholders’ vote. In addition, the competition for qualified personnel
in the biopharmaceutical and pharmaceutical field is intense, and our future success depends upon our ability to attract, retain
and motivate highly-skilled scientific, technical and managerial employees. We face competition for personnel from other companies,
universities, public and private research institutions and other organizations. If our recruitment and retention efforts are unsuccessful
in the future, it may be difficult for us to implement our business strategy, which could have a material adverse effect on our
We expect to expand our development, and regulatory
capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
We expect to experience growth in the number
of our employees and the scope of our operations. To manage our anticipated future growth, we must continue to implement and improve
our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified
personnel. Due to our limited financial resources, we may not be able to effectively manage the expansion of our operations or
recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert
our management and business development resources. Any inability to manage growth could delay the execution of our business plans
or disrupt our operations.