||others may independently develop similar or alternative technologies without infringing our intellectual property rights;|
||third parties may compete with us in jurisdictions where we do not pursue and obtain patent protection;|
||pending patent applications that we own may not lead to issued patents;|
||patents that we own may not provide us with any competitive advantages, or may be held invalid or unenforceable;|
||third parties may assert an ownership interest in our intellectual property;|
||we may not develop or in-license additional proprietary technologies that are patentable; and|
||the patents or proprietary rights of others may have an adverse effect on our business.|
Should any of these events occur, they could significantly harm
our business and results of operations.
Risks Related to Our Business and Industry
If we fail to attract and keep senior management and key scientific
personnel, we may be unable to successfully develop our products, conduct our clinical trials and commercialize our product candidates.
Our future growth and success depend on our
ability to recruit, retain, manage and motivate our employees. We are highly dependent on our senior management team, in particular,
Timothy Noyes, our President and Chief Executive Officer, Steven Burke, our Senior Vice President and Chief Medical Officer, George
Eldridge, our Senior Vice President, Chief Financial Officer, Treasurer and Assistant Secretary, Scott Toner, our Senior Vice President
of Marketing, and Daniel Gottlieb, our Vice President, Corporate Development, as well as the other principal members of our management
and scientific teams. Although we have formal employment agreements with our executive officers, these agreements do not prevent
them from terminating their employment with us at any time. The loss of the services of any member of our senior management or
scientific team or the inability to hire or retain experienced management personnel could adversely affect our ability to execute
our business plan and harm our operating results.
Because of the specialized scientific and managerial
nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel.
We do not currently carry “key person” insurance on the lives of members of executive management. The competition for
qualified personnel in the pharmaceutical field is intense. Due to this intense competition, we may be unable to continue to attract
and retain qualified personnel necessary for the development of our business or to recruit suitable replacement personnel. In addition,
we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development
and commercialization strategy including, F. Nicholas Franano, our scientific founder. Our consultants and advisors may be employed
by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their
availability to us.
We will need to significantly increase the size of our organization,
and we may experience difficulties in managing growth.
We are currently a small company and in order
to commercialize our potential products, we will need to increase our operations and expand our use of our third-party contractors.
We plan to continue to build our compliance, financial and operating infrastructure to ensure the maintenance of a well-managed
company including hiring additional staff within our regulatory and clinical groups as we move into later stages of our Phase 3
development. We intend to recruit an in-house commercial organization in the United States focused on promoting vonapanitase, if
it is approved. We currently do not have a sales and marketing capability and therefore intend to recruit a specialty sales force
of approximately 75-100 representatives in anticipation of vonapanitase's approval. We estimate it will take three to six months
to recruit this specialty sales force. We will need to expand our employment base when we are in the full commercial stages of
our current potential product's life cycle.