PAUL L. HALLENBECK, PH.D.

Phone: (484) 883-9725 | Email: phallenbeck@verizon.net | www.linkedin.com/in/paulhallenbeck/

PROFESSIONAL PROFILE

Hands-on, innovative, industrious, results-driven research and development leader and passionate scientist with 20 years of experience in the biotechnology industry with expertise covering all phases of drug development. Skilled in building, motivating, managing, and leading multi-disciplinary, cross-cultural teams, and interfacing with scientists/KOLs/CROS/executives to drive technology and therapeutic drug discovery and development forward in a high quality, cost effective, and expeditious manner. Achievements include discovering numerous innovative therapeutic compounds and successfully bringing them to INDs and through clinical development. Quality record of discovering/identifying scientific, medical, and business opportunities, developing and implementing strategic plans, financing, and managing start-up through later stage biotechnology companies and programs and divisions within Pharma. Published author, multiple award winner, patent holder, and articulate public speaker with 30+ publications, 35+ patents/patent applications, 150+ scientific and regulatory reports, INDs, business plans, presentations at academic, pharma, biotech, FDA, VC investor, board meetings, and execution of licensing deals.

SELECTED CAREER HIGHLIGHTS

Sole founder of Neotropix, a cancer therapeutics/technology start-up with novel early stage oncology compound in-licensed from Novartis. Built and led team that successfully performed all pre-clinical testing required for IND approval, discovered key biomarkers and incorporated them into the Phase I/II clinical trial, manufacturing GMP clinical lot, and filed a successful IND within 15 months of funding. These achievements were recognized by the receipt of a prestigious Entrepreneur of the Year Award from Ernst and Young. Co-led Neotropixs lead compound through a successful Phase I/II trial that established an excellent safety record at the highest doses tested, determined the recommended dose for a Phase IIb trial and demonstrated compelling evidence of efficacy. Formed major collaborations with KOLs (e.g. Baylor, Harvard, Johns Hopkins, NCI). Developed pipeline of novel oncology therapeutic compounds and advanced them to early development. Obtained FDA/Regulatory approval and NCI support for a randomized Phase IIb in small cell lung cancer and a Phase I in pediatric cancers. These achievements were recognized by the receipt of the Frost and Sullivan Product Innovation Award. At Novartis Pharmaceuticals/prior subsidiary discovered and developed numerous compounds targeted to pharmacologically desired sites by being innovative, creating a clear strategic vision, building and managing stellar multi-disciplinary and multinational- teams, liaising with international pharmaceutical, scientific, and business experts, and managing multiple collaborations with KOLs (e.g. Harvard, NIH, GNF, Scripps and within therapeutic areas at Novartis). Utilized state of the art knowledge of disease and a combination of approaches (immunotherapeutic, virotherapeutic, antibody, protein, and small molecule). Played a major role in establishing, developing, and managing key areas of research (e.g. targeting, drug delivery, predictive pre-clinical models, noninvasive imaging, angiogenesis, gene therapy, functional genomics), resulting in significant Novartis investment and leadership in these areas. Brought numerous compounds to official Novartis approval for clinical development. Participated and led international clinical development-, translational medicine-, technology-, and licensing- project teams interacting with key areas such as Regulatory, Manufacturing, Clinical, Commercial, and Translational areas within Novartis. These accomplishments were recognized by the receipt of a Lifetime Achievement Award from Novartis and continuously promoted to positions of higher responsibility.

AREAS OF EXPERTISE/EXPERIENCE
ADME Angiogenesis Antibodies Biologics Biomarker Discovery, Validation & Utilization Budgeting Business Development Capital Fund Raising Cellular/Molecular/Cancer Biology Clinical Communication CMC CMOs/CROs Development Discovery Drug Compound Screening, Evaluation & Selection Due Diligence Drug Delivery FACS Functional Genomics Gene Regulation Gene Therapy Imaging Immunology/Immunotherapeutics In/Out Licensing KOL Collaborations Leadership Management Manufacturing Mechanism of Action Oncology Patent Filing/Prosecution PK/PD PreClinical/Non-Clinical Testing Regulatory Small Molecules Stem Cells Strategic Planning/Execution SiRNA Targeting Team Building Technology Technology Transfer Toxicology Translational Biology, Research & Medicine Vectors Validation

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PROFESSIONAL EMPLOYMENT EXPERIENCE

Synbody Biotechnology, Inc., Farmington, CT 2011 - Present Founder, President, Chief Executive Officer and Executive Director Start-up Company Identified promising antibody like platform technology and therapeutic oncology lead compounds from Clinical Innovations Branch of the Biodesign Institute of Arizona State University (ASU). Performed extensive due diligence, business development, incorporated company and obtained exclusive worldwide license for therapeutics and diagnostics. Determined budget and resource requirements necessary to discover and develop novel therapeutic drug leads. Wrote high quality and compelling business, scientific, medical plan. Raised $1M in seed funding and obtained several additional smaller grants. Established initial management team, board, advisors, and research collaborations. Obtained high quality laboratory space, transferred technology from ASU and built early research team. Led team and research that improved the activity, selectivity, affinity, and stability of a potential oncology compound directed at AKT1, a key target in the PI3K/AKT/mTOR signaling pathway known to be altered in the majority of cancer indications. Also discovered novel quality drug leads that inhibited the function of activated and mutated KRAS selectively. Led team in the discovery and development of novel antibiotics to the main multi-drug resistant bacteria causing pneumonia related morality. Developed KOL collaboration with Mount Sinai to broaden the activity of SBIs antiviral to influenza, previously demonstrated to block influenza mediated death in animal models with one strain of influenza. Created revenue generating division and several early stage deals with partners to provide nonclinical products in the pharmaceutical industry such as in manufacturing and diagnostics. Created several prototypes for this business including a potential compound to replace Protein A in manufacturing and as a research tool. Revenue projected at > $2M in 2014. NISCO International, Rochester, MN 2010 President and Chief Scientific & Medical Officer Start-up Company Led operations, research and medical for this start-up biotechnology company focused on state of the art noninvasive imaging and targeted cancer therapeutics developed at Mayo Clinic. Liaised with Mayo Clinic physicians, scientists and technology transfer dept. to create and implement strategic business, research, financial and medical plan and deliverables. Assisted Mayo Clinic/NISCO in obtaining $2.85 M SBIR grant. Neotropix, Inc. Malvern, PA 2004 - 2009 President, Chief Scientific Officer, Executive Director 2006 2009 Early Stage Oncology Company Co-led Neotropixs lead compound through a successful Phase I/II clinical trial that established an excellent safety record at the highest doses tested determined the recommended dose for a Phase IIb clinical trial and demonstrated compelling evidence of efficacy and proof of concept. I also had a major leadership role in working closely with the FDA and regulatory authorities to advance the trial. Completed a profound and compelling quality non-clinical data package including toxicology in multiple species including primates, over 30 models of efficacy, ADME, PK/PD and numerous combination studies. Established and performed CLIA based clinical testing to support the trial and co-led the development of a pilot commercial manufacturing process and formulation. Outsourced CLIA testing to CRO in 2009. Discovered additional mechanism of action and identified biomarker candidates tied to mechanism of action and incorporated these and other translational aspects into future trials. Obtained FDA approval and NCI support for a randomized Phase IIb clinical trial in small cell lung cancer and a Phase I clinical trial in pediatric cancers, both trials currently ongoing. Built pipeline through utilization of platform technology developed at Neotropix and securing option agreement with University of Minnesota and additional research. Led team in discovering therapeutic compounds (cancer vaccines/immunotherapeutics and monoclonal antibodies), preclinical testing, and early development to point of board consideration for further development. Expanded indications and utility of lead

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compound by leading in-house efforts, as well as instituting and managing academic collaborations with key opinion leaders (e.g. Baylor, Harvard, Johns Hopkins Mary Crowley, NCI). Expanded intellectual patent portfolio from one patent filed in 2003 and in-licensed from Novartis to over 15 patents with broadened portfolio. Assisted in raising an additional $12M venture capital/venture debt financing. Developed and presented company business and scientific strategy, plans, and progress to Board of Directors, investors, large pharma and biotech firms, and held key meetings with scientific and medical experts as well as KOLs. Served as Board Director, primary contact for manufacturing, and co-contact for FDA and CRO. Managed $4M annual budget. These achievements were recognized by the receipt of the prestigious Frost and Sullivan Product Innovation of the Year award in 2009.

Founder, President, Interim Chief Executive Officer, Chief Scientific Officer, and Executive Director 2004 2006 Start-up Company Sole founder of Neotropix, a cancer therapeutics/technology start-up with novel early stage oncology compound in-licensed from Novartis. Built and led project team that successfully performed all pre-clinical testing required for IND approval, discovered key biomarkers and incorporated them into the Phase I/II clinical trial, manufactured and tested a GMP clinical lot, established a CMO relationship, and filed a successful IND. These milestones, accomplished in an expeditious (1.5 years), cost-conscious, and high quality manner, were especially unprecedented in that the compound class itself (~cancer vaccine approach) was novel and never before tested in man. Established company by developing strategic, clinical and business plan, securing $350K seed round, out-sourced proof of concept research to CROs, secured exclusive license from Novartis Pharmaceuticals to utilize, and enhance key technology and potential therapeutic and secured $10 M in Series A funding. Relocated company to Malvern, PA from Gaithersburg, MD. Obtained license from Crucell to in-license and utilize key manufacturing technology for Neotropix product manufacturing. Built 7,500 square foot vivarium containing facility with key drug development capabilities. Developed relationship and worked closely with the FDA and regulatory authorities to move product toward IND filing. Established relationship with KOL in SCLC at Johns Hopkins and secured agreement as Principle Investigator and clinical site. PI also participated (and still is) in extensive study into mechanism of action and identification of biomarkers. Established SAB/CAB with KOLS. Established CRADA with NCI that performed extensive in vitro screening and evaluation. Obtained clinical and regulatory oversight deal with CRO. Obtained US Oncology agreement to conduct clinical trial at 9 sites. Hired, built and developed key team (pre-clinical, regulatory, manufacturing, and clinical) to execute on company plan and led them to completing a compelling preclinical package for IND filing including efficacy, POC, MOA, ADME, biodistribution, and PK in multiple relevant models. Led all GLP studies including animal toxicity studies and CMC demonstrating a compelling efficacy and safety profile. Created pilot process to manufacture Phase I and toxicology lots. Led manufacturing and CMO agreements which resulted in successful toxicity and clinical lot manufacturing for Phase I trial. Discovered key biomarkers and utilized them and surrogates of early activity in clinical trial design. Established and qualified assays for testing clinical samples of fluids (stool, sputum, urine, blood, nasal swabs, and tumor tissue when available) of patients in trial and performed CLIA based assays at facility. Led all translational aspects of moving from research into the Phase I/II trial and beyond. Developed and presented company strategy, plans, and progress to Board of Directors, investors, large pharma and biotech firms, and held key meetings with scientific and medical experts as well as KOLs. Served as Board Director, primary contact for manufacturing, FDA and CRO. Managed $4M annual budget. Obtained IRB and IBC approval and established multiple clinical trial sites. These achievements were recognized by the receipt of a prestigious Entrepreneur of the Year Award from Ernst and Young in 2006. Novartis Pharmaceuticals Gaithersburg, MD 1996 - 2003 Fully Integrated Program Deputy, Senior Project Leader, Senior Fellow, Novartis Leading Scientist 2003 Co-led managing Novartiss Cell and Gene Therapy Division (formerly Genetic Therapy, Inc. and Systemix), ~$20M annual budget, ~100 personnel, and represented department at Novartis Global Board meetings.

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Played key role in successfully out-licensing technology and potential products from this division to Cell Genesys. Participated and in several instances led international multi-disciplinary, multi-cultural clinical development-, translational medicine-, technology-, and licensing- teams. Participated in developing and implementing divisions and Novartis strategy including in translational medicine, functional genomics, angiogenesis, gene regulation, and gene therapy fields, and assisted in in-licensing/acquisition analysis, duediligence, and technology/therapeutic opportunities evaluations. These areas received significant investment from Novartis enabling Novartis to capitalize on opportunities be competitive in emerging areas of science. business, medical, and research areas. Led development of potential products toward clinical trials, as well as key technology platforms. Initiated collaborations internally and with academic institutions and KOLs at Scripps, NIH, Hammersmith Hospital, Harvard and Dana Farber. Instrumental in the discovery and development of an immunotherapeutic oncology compound receiving Novartis full development approval that was successfully tested in a Phase I/II first in man clinical trial for bladder cancer. Optimized product development by liaising with clinical, regulatory, manufacturing, and translational medicine groups and ensuring customers were informed of new results, plans, timelines, and strategy.

Program Head, Senior Fellow, Novartis Leading Scientist 1999 2002 Led matrixed multi-disciplinary multi-cultural clinical development team composed of experts from pre-clinical, research, toxicology, early clinical, marketing, manufacturing, translational and regulatory. Team led innovative drug candidates for oncology indications through efficacy, toxicology, ADME, biodistribution, PK, toxicology, and manufacturing and successfully brought compounds into clinical development after major approvals at Novartis boards. Played major role for Novartis for spearheading research into predictive pre-clinical models, non-invasive imaging, targeting, angiogenesis, novel gene therapy approaches, and functional genomics, most of which resulted in significant investments and growth opportunities at Novartis. Served on Research Board of our Division and as Research Representative on International Project Teams. Led research that successfully discovered numerous innovative therapeutic oncology compounds and concepts by utilizing state of the art knowledge of pathways and genes altered in cancer, and approaches to target and kill cancer cells (angiogenesis, pro-drug, apoptosis, immune mediated, etc.), and a combination of viral vector, protein engineering, molecular biology, biologics, and small molecule approaches achieving compelling efficacy, selectivity, and safety in a variety of in vitro and in vivo models. Developed dominant intellectual property portfolio comprised of U.S. and international patents. Initiated and managed extensive collaborations with Key Opinion Leaders at Genomics Institute of the Novartis Research Foundation, Institute for Cancer research and Hammersmith Hospital in the UK, Harvard, and Scripps. Represented research to senior leaders and governance bodies within Novartis and effectively communicated status, issues, resource requirements, and budget as well as progress, data, value, and strategy. Participated in performing due diligence on potential compounds and technology from scientific perspective. Assisted in developing models and testing compounds from Novartis. Represented Novartis at numerous invited international presentations and FDA sponsored workshops. Managed $3M annual program budget and team of 18. Recognized for outstanding accomplishments and leadership with receipt of a prestigious Lifetime Leading Scientist VIVA Award in December 2001. Program Head, Tumor Targeting and Anti-Angiogenesis 1996 1999 Led and managed project teams that championed expeditious, accurate and high quality innovative research to discover oncology therapeutics. Successfully discovered gene therapy concepts involved in secreting therapeutic proteins (e.g. anti-angiogenic) systemically that were targeted specifically to cancer site. Discovered how to selectively control replication of numerous viruses such that they replicated in and killed cancer cells selectively and induced immune response. Performed extensive in vitro and in vivo analysis, developed and conducted assays created to detect expression level, biodistribution and functional activity in vitro and in vivo. Created and tested additional concepts developed by utilizing state of the art knowledge of pathways/targets altered in cancer, approaches to target and kill cancer cells such as using pro-drug, immune mediators, and

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apoptotic modalities and a combination of viral vector, protein engineering, molecular biology, biologics, and small molecule approaches maximizing efficacy and safety. Implemented targeted strategies and successfully identified targeting ligands and technology through collaborations with cardiovascular, oncology, and genetic disease programs and therapeutic areas within Novartis and with KOLs (Scripps, NIH, Harvard). Developed and presented program objectives, priorities, plan, budget, reports, and reviews. Contributed to external licensing opportunities, due-diligence, patent applications and prosecution, , and research management of our division Directed all laboratory functions, selected compounds for development, and led team of eight direct reporting program professionals. Represented teams to senior leaders and governance bodies within Novartis and effectively communicated status, issues, resource requirements, and budget as well as progress, data, and value of compounds and concepts discovered.

Prior experience from 1993-1995 as Senior Scientist II-III at Genetic Therapy, Inc., (GTI) in cancer therapeutics discovery and development. GTI was ultimately purchased by Sandoz in 1995 which then merged with Ciba Geigy to form Novartis in 1996. Also had 4 years post-doctoral work as Staff Fellow & National Research Council Fellow with National Institutes of Health (NIH) studying gene regulation in mammalian cells, cancer and other diseases following receipt of Ph.D. in 1989.

EDUCATION

University of Illinois Ph.D. & M.S. in Microbiology Siena College B.S. in Chemistry, Minor in Biology, Magna Cum Laude Hudson Valley Community College A.A.S. in Medical Laboratory Technology

AWARDS & HONORS

U.S. Frost & Sullivan Award for Product Innovation of the Year Ernst & Youngs Life Sciences Entrepreneur of the Year for Greater Philadelphia Region Eastern Technology Councils Enterprise Awards for Finalist in CEO Category Eastern Technology Councils Enterprise Awards for Finalist in Start-up Company Novartis Leading Scientist And Lifetime Achievement VIVA Award Novartis Poster/Seminar Award (1/10 awarded worldwide each year) National Research Council Research Associate Award Whos Who in Science and Engineering Department of Health and Human Services, Public Health Service Training Grant Award Excellence in Major Field from American Institute of Chemistry

AFFILIATIONS/MEMBERSHIPS (PAST/PRESENT)

American Association for the Advancement of Science American Association for Clinical Oncology American Association for Cancer Research American Society for Microbiology Beta Beta Beta Biological Society Editorial Board of Gene Therapy New York Academy of Sciences National Physics Honor Society (Sigma Pi Sigma) Fellowship award at NIH as National Research Council Fellow

Patents, Publications, and References Furnished Upon Request