About the Company

At Keystone Biologics, we believe that great pharmaceutical drugs can and should be developed with minimal risk – for patients, for the company, for investors, and with respect to the regulatory approval process. We have built a strong and lasting foundation for the company with this risk-minimization approach to all aspects of our business.

We believe we can minimize the clinical risk of our primary product candidate, kPPF1 for ulcerative colitis, because it:

  • Potentially lowers risk to patients than current approved therapies
  • Provide preliminary efficacy comparable to currently approved products
  • Similar biologic products have demonstrated few Serious Adverse Events (SAE) related to therapy to date other than typical infusion reactions
  • Offers a potentially enhanced safety profile with naturally occurring plasma-derived protein 

We believe we can minimize regulatory risk through:

  • More efficient study designs with Orphan Product designation
  • Potentially favorable safety profile appealing to FDA
  • Lower cost of therapy compared with current medications
  • An appealing new safer and more productive technology for plasma-derived proteins

We believe we can minimize operational risk of Keystone Biologics as a business and the development of kPPF1 for ulcerative colitis through:

  • More efficient development projects with the expert quality systems we employ
  • Minimized development time with efficient virtual programs
  • Long-term experience interacting with agency reviewers in a wide variety of disciplines and therapeutic areas

We believe we can minimize risk to our investors because:

  • Keystone can minimize development costs with virtual business model using expert partners
  • Keystone can minimize development time with efficient study designs
  • Keystone’s protein formulation has demonstrated the potential as a safe and effective treatment
  • Keystone can offer a shorter-term return on investment based on the current existence of clinical data demonstrating potential safety and efficacy along with the minimization of costs associated with the program using the virtual model and efficient study designs
  • kPPF1 offers an extended clinical potential of initial development project
  • kPPF1 offers an already proven indication