David J. Burkhart Ph.D.

Research Professor Biomedical & Pharmaceutical Sciences Skaggs School of Pharmacy 32 Campus Drive, Skaggs 395 Missoula, MT 59812-1552 (406)- 361-1672 Email: [email protected] Education/ Work Experience:  Research Professor, Biomedical & Pharmaceutical Sciences, University of Montana 2016 – Present  Chief Operating Officer and Co-founder, Inimmune Corp. 2016 - Present  Investigator, GlaxoSmithKline Biologicals R&D, December 2011 – 2016 o Manager of Formulations and Bioconjugation R&D Group with over 9 years of Pharmaceutical Industry Experience  Principal Scientist GlaxoSmithKline Biologicals R&D, June 2008 – November 2011  Senior Scientist Hollister-Stier Laboratories 2005 - 2008  Director of Research, Serendipity Pharmaceuticals, May 2005 – Present  Postdoctoral Research Associate, University of Colorado, Boulder: May 2002 - 2005  Ph.D. in Organic Chemistry, University of Idaho. May 2002  B.S. (Honors) in Chemistry, University of Idaho, May 1997

Special Skills and Expertise:  Expertise in bioconjugation chemistry and preclinical vaccine process development as the manager of a multidisciplinary Bioconjugation and Formulations R & D Group with 9 years of industry experience.  Expertise with a wide variety of formulation and drug delivery techniques including nanoparticles (liposomes, microspheres, emulsions, suspensions, etc.).  Served on several multidisciplinary project teams with representatives from manufacturing, engineering, regulatory, validation, and quality departments.  Supervised and trained 4 direct reports (Scientist II, Senior Scientist, Postdocs) and led research teams with as many as 7 members from multidisciplinary backgrounds.  Experience with API and drug product testing of both small molecules and proteins using a broad array of instrumentation (HPLC, IR, UV, NMR, ESI-MS, DLS etc.) in a cGMP environment.  Analytical method development (stability indicating methods), optimization, validation, and technology transfer experience with various products in different stages of development (phase I, II, III,).  Good working knowledge of ICH, USP, EP, JP guidelines with respect to product testing and stability programs.  7 years of experience in biologics development research (synthesis, characterization, formulation, in-vitro and in-vivo efficacy, stability) and optimization.  Significant experience with in vitro and in vivo biological assay evaluating cancer therapeutics (flow cytometry, fluorescence microscopy, MRI, xenograft and toxicity models).  Expertise in document writing (SOPs), publication of papers, grant writing and patent applications using Microsoft Word, Powerpoint, Excel. Experience with molecular modeling (MOE and Pymol) and chemistry software (Beilstein Crossfire, SciFinder Scholar, Chemdraw).  Excellent leadership/communication skills and ability to motivate a multidisciplinary team.

Selected Publications/Patents: 1. Inventor on 6 GSK provisional patents filed for the use of novel sublingual vaccine formulations, 2014-2015; Inventor on novel peptide therapeutic patent for autoimmune disorders, 2014; Inventor on patent for immunotherapeutic vaccine targeting Alzheimer’s disease, 2012; patent for improved process in manufacture of a vaccine for the treatment of chemical addiction, 2010. 2. Oberoi, H.; Yorgensen, Y.; Evans, J.; Burkhart, D.; PEG modified liposomes in combination with methylglycol chitosan enhances the murine sublingual immune response to influenza vaccination Journal of Controlled Release, Vol 223, 10 Feb 2016. 3. Spinner, J.; Oberoi, H.; Yorgensen, Y.; Burkhart, D.; Evans, J.; Methylglycol chitosan and a synthetic TLR4 agonist enhance immune responses to influenza vaccine administered sublingually Vaccine, Volume 33, pages5845-5853, 2015. 4. Hallé, M.; Tribout-Jover P.; Lanteigne, A.; St-Jean, J.; Jodoin, R.; Boulais, J.; Girouard, M.; Constantin, F.; Migneault, A.; Renaud, F.; Mallett, C.; Burkhart, D.; Pilorget, A. ; Palmantier, R.; and Larocque, D. Methods to Monitor Monocytes-Mediated Amyloid-Beta Uptake and Phagocytosis in the Context of Adjuvanted Immunotherapies; Journal of Immunological Methods, 424, 64-79 2015. 5. Barthel, B.; Rudnicki, D.; Colvin, S.; Burkhart, D. J.; Koch, T. Synthesis and biological characterization of protease-activated prodrugs of doxazolidine J. Med. Chem. Volume55, pp. 6595-6607, 2012. 6. Patel, Sarjubhai A.; Rajale, Trideep; O'Brien, Erin; Burkhart, David J.; Nelson, Jared K.; Twamley, Brendan; Blumenfeld, Alex; Gerdes, John M.; Bridges, Richard J.; Natale, Nicholas R. Isoxazole analogues bind the System Xc- transporter: Structure-activity relationship and pharmacophore model Bioorganic & Medicinal Chemistry Volume18 Issue1 Pages202-213, 2010. 7. Burkhart, David J.; Barthel, Benjamin L.; Kalet, Brian T.; Rudnicki, Daniel L.; Post, Glen C.; Koch, Tad H. Anthracycline-formaldehyde conjugates and their targeted prodrugs Topics in Current Chemistry Volume 283 Pages141-170 2008. 8. Methods for treating cancer with doxazolidine and prodrugs thereof Koch, Tad H.; Burkhart, David J.; Post, Glen C.; Nafie, Jordan W.; Kalet, Brian T.; Barthel, Benjamin L.; Rudnicki, Daniel L. PCT Int. Appl. 2007, WO 2007102888 A2 20070913. 9. Burkhart, D. J.; Barthel, B.L.; Post, G.C.; Kalet, B.T.; Nafie, J.W.; Shoemaker, R.K.; Koch, T.H. "Design, synthesis, and preliminary evaluation of doxazolidine carbamates as prodrugs activated by carboxylesterases", J. Med. Chem. 49, 7002-7012, 2006. 10. Burkhart, D.J., Natale, N.R. The Isoxazole Ionotropic glutamate neurotransmitters Curr. Med. Chem., 12 (5), 617-627, 2005. 11. Burkhart, D.J.; Kalet, B.T.; Coleman, M.P.; Post, G.C.; Koch, T.H. “Doxorubicin-formaldehyde conjugates targeting alpha-v beta-3 integrin”, Mol. Cancer Therap., 4, 1593-1603, 2004. 12. Burkhart, D.J.; McKenzie, A.R.; Nelson, J.K.; Myers, K.I.; Zhao, X.; Magnusson, K.R.; Natale, N.R. Catalytic Asymmetric Synthesis of Glutamate Analogues Org. Lett. 6(8), 1285-1288, 2004.

Recognition and Awards: GSK Silver Award for Outstanding performance in support of immunotherapeutic vaccine project August 2010 GSK Silver Award for Outstanding performance in support of Alzheimer’s vaccine research project December 2012 GSK Bronze Award for Outstanding performance in support of cancer immunotherapeutic research December 2014

Contacts for References: Dr. Jory Baldridge, GlaxoSmithKline Biologicals (406)-214-1185 Dr. Melinda Hutton, GlaxoSmithKline Biologicals (406)-360-1994 Dr. Nicholas Natale, University of Montana (406)-243-4132