33 Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential vii Revised: June 2015 Revision History S AP Version SAP Date Protocol Version Reason for Change Final 28 Feb ruary 2013 Amendment 5 Initial version Amendment 1 29 June 2015 Amendment 6 Updated per BNIT- PRV-301 protocol amendment 6 Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential 1 Revised: June 2015 1.Introduction P ROSTVAC™ ( PROSTVAC V and PROSTVAC F ; PROSTVAC VF ) is a novel candidate prostate cancer immunotherapy for the treatment of prostate cancer. It is a viral vector based product that is administered in seven subcutaneous vaccinations over a five month period. In a randomized controlled Phase 2 trial, PROSTVAC therapy was associated with a prolongation of survival in men with metastatic castration -resistant prostate cancer. P ROSTVAC is a PSA (prostate -specific antigen) -based immunization strategy. It is intended to generate immune responses to prostate specific antigens and prostate cancer cells. It uses poxviral vectors to introduce modified PSA to the subject in an immunogenic manner to break self-tolerance, and thereby induce immune responses directed against prostate cancer cells. P ROSTVAC is comprised of two component viral vectors; a recombinant vaccinia ( PROSTVAC V) and a recombinant fowlpox ( PROSTVAC F ) virus to be used sequentially in a heterologous prime -boost vaccination regimen. Both viruses contain four human genes: prostate- specific antigen (PSA) and three genes encoding human immunological costimulatory molecules: B7.1,intercellular adhesion molecule- 1 (ICAM -1), and leukocyte function- associated antigen -3 (LFA - 3) (designated TRIad of COstimulatory Molecules or TRICOM). The simultaneous expression ofPSA and TRICOM enhances the immune response. The PSA transgene is modified at one amino acid (I155L), to enhanc e binding and immunogenicity of a particular peptide epitope in HLA- A2-expressing subject s. 2.Objectives This is a randomized, double-blinded, placebo- controlled, multi -center, three-arm study.