Overview

GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec’s lead product, TNFerade, is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer. Additional clinical trials are in progress in rectal cancer, head and neck cancer, and melanoma. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and influenza. These product candidates are under development and have not been approved for use.

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Investment Highlights

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Profile

GenVec, Inc., based in Gaithersburg, Maryland is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Each of the Company's gene-based therapeutic product candidates uses a common patent-protected technology platform to deliver genes that produce medically beneficial proteins directly at the site of disease.

The Company is in advanced clinical trials for pancreatic cancer and in clinical trials for wet age-related macular degeneration (AMD). The Company is also looking for vaccines to diseases such as HIV, Malaria, Foot and Mouth Disease, Seasonal and Pandemic Influenza and others. Lastly, the Company is developing a product concept to restore hearing or balance function through the regeneration of critical cells of the inner ear. This product concept has shown preclinically that the production of the ATOH protein results in the formation of new inner ear sensory hair cells, and the restoration of hearing and balance function.

With advanced clinical trials, a huge portfolio of research being performed for a vast amount of diseases, GenVec, Inc. (Nasdaq: GNVC) is positioned to be close to commercial production, especially with its TNFerade procedure, should it pass Phase III clinical trials. The Company is flirting with its 52 week low as it gets sucked into the market meltdown that occurred over the last few months.  The Company's positive portfolio of research and attractive stock price should be reason enough for investors to give this company a second look and do their own due diligence.

Company Product Overview:

• TNFerade™ represents a novel approach to treating cancer in combination with radiation and/or chemotherapy by introducing tumor necrosis factor-alpha (TNF-alpha), a potent anti-cancer protein, directly into tumors. Pancreatic cancer is the lead indication for TNFerade™. The Company is conducting a 330-patient randomized, controlled Phase III clinical trial (the PACT study) designed to assess the safety and clinical benefit of using TNFerade™ in combination with standard of care treatment in patients with locally advanced pancreatic cancer. In addition to the Phase III PACT study, Phase II studies are in progress in rectal cancer and melanoma, and Phase I/II studies are in progress in head and neck cancer.
• AdPEDF is being developed for patients with wet age-related macular degeneration (AMD) to determine whether pigment epithelium-derived factor (PEDF) prevents vision loss in this leading cause of blindness in people over the age of 50. The Company has completed a Phase I clinical trial of PEDF in patients with wet AMD. Evaluation of data from this trial is ongoing.
• TherAtoh Atonal Therapy is a product concept to restore hearing or balance function through the regeneration of critical cells of the inner ear. Hearing and Balance require specialized cells of the inner ear called sensory hair cells. During embryonic development a gene termed atonal (ATOH) induces the generation of these cells. GenVec has shown preclinically that the production of the ATOH protein results in the formation of new inner ear sensory hair cells, and the restoration of hearing and balance function.

The Company is also using its proprietary adenovector technology to develop vaccines for infectious diseases.

• HIV vaccine in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID)
• Malaria vaccine in collaboration with U.S. Navy and PATH's Malaria Vaccine Initiative
• Foot and Mouth Disease antiviral and vaccine program in collaboration with the United States Department of Homeland Security (DHS) and the United States Department of Agriculture/Agricultural Research Services (USDA-ARS)
• Seasonal and pandemic influenza vaccines in collaboration with the NIAID
• HSV-2 vaccine under an SBIR grant from NIAID.

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TNFerade™ for Pancreatic Cancer

TNFerade™ Biologic is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNFa), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade™ Biologic stimulates the production of TNFa in the tumor. GenVec is developing TNFerade™ Biologic for use in combination with radiation and/or chemotherapy for the treatment of various cancers.

GenVec clinical investigators have conducted multiple Phase I and II clinical studies with TNFerade™ Biologic to evaluate its safety and potential efficacy in treating cancer. They have seen promising anti-tumor results against a variety of solid tumors, including pancreatic cancer, which is currently the lead indication for TNFerade™ Biologic.

GenVec is conducting a pivotal Phase III clinical trial of TNFerade™ Biologic, known as the PACT study, in patients with locally advanced pancreatic cancer. This pivotal study is designed to assess the clinical benefit of using TNFerade™ Biologic in combination with standard of care (5-FU/radiation therapy followed by gemcitabine or gemcitabine/erlotinib maintenance therapy) treatment in patients with this disease.

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AdPEDF for Macular Degeneration

AdPEDF is under development for the treatment of wet age-related macular degeneration (AMD). AMD is a progressive eye disease characterized by the growth of abnormal blood vessels in the center portion of the retina (the macula), resulting in loss of vision. GenVec believes that early intervention therapy with AdPEDF holds the promise to stabilize or improve vision in patients with AMD.

AdPEDF uses GenVec’s proprietary adenovector, a DNA carrier, to deliver the human Pigment Epithelium - Derived Factor (PEDF) gene, resulting in the local production of AdPEDF in the treated eye. PEDF is normally produced in the eye and serves two important functions. PEDF regulates normal blood vessel growth and protects the photoreceptors (the vision - sensing cells of the eye responsible for sight). AdPEDF’s key differentiation from other therapies is its potential to protect the photoreceptors damaged by fragile, leaky, abnormal blood vessels and inhibit blood vessel growth. In numerous animal studies, AdPEDF has been shown to rapidly elevate the intraocular AdPEDF protein levels in the eye, inhibit abnormal blood vessel growth, and cause abnormal blood vessels to regress while protecting the eye’s photoreceptors.

GenVec has completed the dose escalation portion of a Phase I, multi-center clinical trial in 28 patients with advanced wet AMD. Despite the advanced stage of disease in the patients studied, investigators observed positive changes in vision and retinal appearance at the higher dose cohorts in some patients. No dose limiting toxicities or drug related severe adverse events were observed. Additionally, GenVec has completed enrollment of 22 patients with less severe disease in this Phase I study. Very much like the first 28 patients, no dose limiting toxicities or drug related severe adverse events were observed. Investigators are continuing to collect data from this last cohort of 22 patients.

AMD is the leading cause of blindness in patients over the age of 50. Approximately 200,000 cases of AMD are diagnosed each year in the U.S. and more than 500,000 cases are diagnosed worldwide. Due to its potent multi-action antiangiogenic and neuroprotective activity, AdPEDF holds great promise to treat additional eye diseases, including diabetic retinopathy, diabetic macular edema, dry AMD, glaucoma, and retinitis pigmentosa. These diseases along with wet AMD will afflict more than 50% of the elderly population and represent multiple large commercial opportunities.

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TherAtoh Atonal Therapy – Validated Science; Untapped Market

Atonal Therapy is a product concept to restore hearing or balance function through the regeneration of critical cells of the inner ear. Hearing and Balance require specialized cells of the inner ear called sensory hair cells. During embryonic development a gene termed atonal (ATOH) induces the generation of these cells. GenVec has shown preclinically that the production of the ATOH protein results in the formation of new inner ear sensory hair cells, and the restoration of hearing and balance function. TherAtoH is an adenovector product delivering the human atonal gene (Hath1) to trigger the production of therapeutic proteins by cells in the inner ear.

Addresses Unmet Medical Needs – There are no drug therapies available to treat hearing loss or balance disorders.

This investigational drug is being developed to improve the treatment of inner ear disorders including hearing loss and balance function disorders. According to the National Institute on Deafness and Other Communication Disorders, approximately 28 million Americans have a hearing impairment. Even with the most conservative estimates, this represents an opportunity of at least $6 billion. TherAtoh therapy could be explored for patient segments including those with hearing loss caused by exposure to excessive noise or other trauma, aging, and diseases and infections or their treatment (also in pediatric patients). These segments total approximately 24 million patients. In the United States alone, it is estimated that 5-10% of the population suffers from balance loss and there is little available treatment. The cost of medical care for patients with balance disorders has been estimated to exceed $1 billion per year.

Program is de-risked - The underlying adenovector delivery technology has been proven safe in thousands of patients across a range of diseases and proof of concept of TherAtoh has been established in multiple preclinical models. The program is positioned to be quickly advanced into the clinic.

Recent News and Press Releases

•GenVec Announces Multiple Presentations at the American Society of Tropical Medicine and Hygiene Meeting
PR Newswire (Fri, Dec 5)

•GenVec, Inc. Conference Call to Discuss Interim Survival Data in Pivotal Trial of TNFerade in Locally Advanced Pancreatic Cancer scheduled for 9:00 am ET today
CCBN (Wed, Nov 19)

•GenVec Announces Interim Survival Data in Pivotal Trial of TNFerade in Locally Advanced Pancreatic Cancer
Business Wire (Wed, Nov 19)

•TNFerade(TM) Receives FDA Fast Track Designation for Treatment of Pancreatic Cancer
Business Wire (Tue, Nov 11)

•GenVec Reports Third Quarter 2008 Financial Results
Business Wire (Thu, Nov 6)

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Management

GenVec’s senior management team comprises highly talented and experienced personnel with significant expertise in scientific research and drug development. Members of the management team have extensive backgrounds in biotechnology, drug delivery, clinical medicine, manufacturing and regulatory affairs.

Paul H. Fischer, Ph.D. has served as President and Chief Executive Officer and as a director of the Company since 1996. Prior to joining GenVec, he was Executive Vice President of Research and Development with Oncologix, Inc., (now Antigenics, Inc.) a biotechnology company. Previous experience included Manager, Cancer Research at Pfizer, Inc., a pharmaceutical company. Dr. Fischer received his B.S. in Biology from the University of Denver and his Ph.D. in Pharmacology from the University of California at San Francisco. Dr. Fischer performed post-doctoral research in Pharmacology at Yale University School of Medicine. He was an Assistant Professor of Pharmacology at the University of Missouri, School of Medicine and an Associate Professor of Human Oncology at the University of Wisconsin, prior to joining Pfizer. Dr. Fischer also serves on numerous community, academic and professional organizations and Boards.

Douglas J. Swirsky joined GenVec in 2006 and serves as Senior Vice President, Chief Financial Officer, Treasurer and Corporate Secretary. Prior to joining GenVec, Mr. Swirsky was a Managing Director and the Head of Life Sciences Investment Banking at Stifel Nicolaus and held the same position at Legg Mason prior to Stifel Financial’s acquisition of the Legg Mason Capital Markets business in 2005. Mr. Swirsky, a Certified Public Accountant and a CFA charterholder, has also previously held investment banking positions at UBS, PaineWebber and Morgan Stanley. His experience also includes positions in public accounting and consulting. Mr. Swirsky received his B.S. in Business in Administration from Boston University and his M.B.A. from the Kellogg School of Management at Northwestern University.

Bryan T. Butman, Ph.D. joined the company in September, 1999 and now serves as Senior Vice President of Vector Operations. Dr. Butman previously served as GenVec’s Vice President of Vector Operations (2005 to 2006), Vice President of Quality (2002 to 2005), and Director of Quality and Analytical Science (1999 to 2002). Prior to joining GenVec, Dr. Butman was Executive Director of Diagnostic Product Research and Development with INTRACEL Corporation, a biotechnology company. Dr. Butman has over 23 years of biotechnology product development experience including clinical gene therapy, human monoclonal antibody and clinical diagnostic products. Throughout his biotechnology career, Dr. Butman has developed successful products in the areas of oncology, cardiovascular disease, infectious disease, food safety and hematology. He has held senior positions within Warner Lambert, AKZO-Nobel, Organon Teknika, PerImmune and INTRACEL. Dr. Butman holds a Ph.D. in Cell Biology from Wayne State University.

C. Richter King, Ph.D. serves as Senior Vice President of Research, and previously as Vice President of New Product Research, an area that he still oversees. Prior to joining GenVec in 1998, Dr. King conducted extensive research into the amplification of the erbB-2 gene, which is associated with common human cancers. Dr. King directed an experienced research group at the Georgetown University Medical School’s Lombardi Cancer Research Center in Washington, DC, where he served as Associate Professor with the University’s Department of Biochemistry. Previously, Dr. King was the Director of Drug Discovery for Oncologix (now Antigenics, Inc.). Dr. King holds a Ph.D. in Biochemistry from Johns Hopkins University.

Milan Kovacevic, M.D., Ph.D. joined GenVec in 2006 and serves as Vice President of Clinical Operations. Dr. Kovacevic brings to GenVec extensive and diverse clinical research experience in the pharmaceutical/biotechnology industry. Prior to GenVec, he served as Senior Medical Director/Medical Director at Alteon, Inc., a biopharmaceutical company. Previous experience includes service as Medical Officer for global safety and Project Manager at Kendle International, a clinical development organization, and Clinical Research Scientist at biotechnology company Cangene Corporation. Dr. Kovacevic obtained his medical degree, Master of Science degree in gastroenterology, and doctoral degree in nephrology at the University of Beograd in Yugoslavia. Prior to entering the pharmaceutical industry, Dr. Kovacevic practiced medicine for ten years.

Mark O. Thornton, M.D., M.P.H., Ph.D. serves as Senior Vice President of Product Development. Dr. Thornton, a Clinical Pharmacologist and Trialist, has divided his 15-year career at FDA and in the biotechnology industry equally between oncology and infectious disease biologics clinical development. At the FDA, he was on the clinical review team for Erbitux(R) for its initial colon cancer indication, and Pegasys(R) for its Hepatitis C indication. At the FDA he also led the initial efforts to establish the FDA Gene Therapy Patient Tracking System and published on the topic of optimizing regulatory pathways for cancer vaccines. In industry, Dr. Thornton has performed Phase I-III clinical trials in both oncology and infectious disease settings, and successfully submitted PLAs for Certiva(TM) while at North American Vaccine and WinRho(R) while at Univax Biologics.
 

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Contact

GenVec, Inc.
65 West Watkins Mill Road
Gaithersburg, MD 20878
Phone: 240 632 0740

Investor Relations Contact:

Douglas J. Swirsky
Chief Financial Officer
65 West Watkins Mill Road
Gaithersburg, MD 20878
Phone: 240-632-5510
Email: ddipirro@GENVEC.com

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FORWARD LOOKING STATEMENTS

This report includes forward-looking statements that reflect GenVec, Inc. current expectations about its future results, performance, prospects and opportunities. GenVec, Inc. has tried to identify these forward-looking statements by using words and phrases such as "may," "will," "expects," "anticipates," "believes," "intends," "estimates," "plan," "should," "typical," "preliminary," "we are confident" or similar expressions. These forward-looking statements are based on information currently available and are subject to a number of risks, uncertainties and other factors that could cause GenVec, Inc.'s actual results, performance, prospects or opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. These risks, uncertainties and other factors include, without limitation, the Company's growth expectations and ongoing funding requirements, and specifically, the Company's growth prospects with scalable customers, and those outlined above. Other risks include the Company's limited operating history, the Company's history of operating losses, consumers' acceptance, the Company's use of licensed technologies, risk of increased competition, the potential need for additional financing, the terms and conditions of any financing that is consummated, the limited trading market for the Company's securities, the possible volatility of the Company's stock price, the concentration of ownership, and the potential fluctuation in the Company's operating results.

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