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Dear Investor, Thank you for requesting information ... - PrecisionIR

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<strong>Dear</strong> <strong>Investor</strong>,<strong>Thank</strong> <strong>you</strong> <strong>for</strong> <strong>requesting</strong> in<strong>for</strong>mation about Inovio Pharmaceuticals, Inc. (NYSE MKT: INO). Weappreciate <strong>you</strong>r time to learn more about the promise of DNA vaccines and immunotherapies and Inovio’svital role in advancing this field. Just this past year Inovio has taken great strides toward its goal of“revolutionizing vaccines.”Vaccines have been the single most significant advancement in the field of medical science, protectingmillions of people from numerous devastating infectious diseases. Un<strong>for</strong>tunately, conventional vaccinetechnology has reached its boundaries in terms of its ability to address an array of today’s diseases anddoes not have the ability to provide therapeutic capabilities against cancers and infectious diseases.Inovio’s vision is to expand the significant medical benefits of the 20th century’s vaccines by creatingsynthetic DNA vaccines and immunotherapies to not only prevent challenging diseases but treat cancersand infectious diseases such as HIV and hepatitis. We also aim to move beyond the “one bug, one drug”model in which a vaccine can protect only against a single known or matched virus strain. We are workingtoward “universal” protection against multiple known and unknown, newly emerging strains of a pathogen.To achieve therapeutic capabilities, our vaccines must stimulate robust T-cell immune responses relevantto specific cancers and infectious diseases. We reported best-in-class T-cell response data from ourcervical dysplasia phase II study that also indicated that the T-cells we generated were able to killtargeted diseased cells. While this first study specifically targets high grade cervical intraepithelialneoplasias (pre-cancers), this DNA immunotherapy is intended to fight all pre-cancers and cancerscaused by HPV types 16 & 18, including cervical, head and neck, and other anogenital cancers – theseare potentially multi-billion dollar markets that we expect to also advance into clinical trials.Inovio has also reported best-in-class T-cell responses from a human study of a DNA vaccine <strong>for</strong> HIV, inwhich our vaccine achieved a seven-fold increase (7% to 52%) in response rate of CD8 T-cells whendelivered with electroporation. This type of data has never been previously reported by anyone else.These reported immune responses are superior in terms of breadth, robustness and durability comparedto alternative technologies. Both of these data sets have been published in peer-reviewed scientificjournals, Science-Translational Medicine and the Journal of Infectious Diseases.Inovio has also reported cross-strain, or universal, immune responses in human studies, with protectiveimmune responses against the eight strains of H1N1 included in the influenza vaccines of the past 40years and the strain responsible <strong>for</strong> the 1918 pandemic flu. Additional H1N1 vaccine data showed thatthis “unmatched” vaccine achieved protective antibody levels comparable to a current “matched” FDAapprovedseasonal influenza vaccine against a currently circulating influenza strain. Our influenzavaccine <strong>for</strong> H5N1 generated protective levels of immune responses against all six strains tested. Inaddition, we rapidly responded to the newly emergent H7N9 threat, designing and manufacturing anH7N9 DNA vaccine within two weeks. In preclinical studies of this influenza DNA vaccine, 100% of thevaccinated animals were protected against sickness and death when they were challenged with a lethaldose of H7N9 virus. These results are important accomplishments on the path toward protective universalvaccines.In September, 2013, we announced that a new application using Inovio’s DNA technology to producemonoclonal antibodies achieved excellent results compared to conventional monoclonal antibodytechnology, while offering various advantages by being DNA-based. This data was published in the peerreviewedHuman Vaccines and Immunotherapeutics.


Inovio is advancing on many fronts. In the next quarters, Inovio plans to start phase I and phase I/IIaclinical trials <strong>for</strong> immunotherapies designed to treat prostate cancer, breast and lung cancers displayingthe antigen hTERT, other HPV-caused cancers, HIV, hepatitis C, and hepatitis B, most of these studiesbeing funded by third parties.<strong>Investor</strong>s would like to see validating efficacy data and partnerships. We recently announced apartnership with Roche, a global leader in innovative cancer drugs, to develop and commercialize Inovio’sprostate cancer (INO-5150) and hepatitis B (INO-1800) immunotherapies. This transaction rewards theconfidence we have always held in our synthetic DNA vaccine and electroporation delivery plat<strong>for</strong>m. Thisagreement provides Inovio with an up-front payment of $10 million and payments upon reaching certaindevelopment and commercial milestones potentially up to $412.5 million. Roche is paying all preclinicaland clinical development costs and would pay a royalty on sales of a successfully commercializedproduct(s). Roche may also pay other development milestone payments if it pursues other indicationswith INO-5150 or INO-1800. Roche’s stated aim is to find first-in-class and best-in-class therapies thatmay become next generation treatments <strong>for</strong> patients with different types of cancer. This partnershipprovides validation of Inovio’s novel technology <strong>for</strong> treating and preventing diseases, provides non-dilutivefunding, and allows us to accelerate our product development pipeline.With respect to efficacy data, we will report the first efficacy data from our novel plat<strong>for</strong>m of SynCon®DNA vaccines delivered using electroporation with top-line phase II data from our HPV immunotherapystudy of late stage cervical pre-cancers in mid-2014. We expect this data to be a potentiallytrans<strong>for</strong>mational catalyst <strong>for</strong> Inovio.We are excited about Inovio’s results and potential on its path to revolutionize vaccines. Please let meknow if <strong>you</strong> have questions.Best regards,Bernie HertelSenior Director, Communications & IRbhertel@inovio.com858 336 5579Inovio Key Highlights• Potentially game-changing phase II efficacy data from lead program mid-2014• Exclusive worldwide partnership with Roche to develop and commercialize products from Inovio’sprostate cancer (INO-5150) and hepatitis B (INO-1800) immunotherapy programs• Additional ongoing discussions with large pharmaceutical companies regarding partnerships• Almost $60M in non-dilutive third party R&D grants and expenditures since 2009• Operating capital through 3Q 2015• Synthetic DNA vaccines with proprietary delivery technology targeting diseases with multi-billiondollarmarkets; designed to extend the powerful capabilities but overcome limitations ofconventional vaccines and alternative immunotherapies• Best-in-class T-cell immune responses displaying killing effect against target cells – designed tofight cancers, HIV, hepatitis and other diseases requiring treatment• Universal antibody immune responses to protect against constantly changing viruses such asinfluenza


• Favorable safety profile with no serious adverse events in over 500 subjects to date• Vaccine market expected to reach $52 billion by 2016, up from $13 billion in 2007• Dominant global patent position, with over 400 patents protecting our electroporation deliverytechnology and novel SynCon® DNA vaccines• Management team and advisors are leaders in the world of vaccines and DNA vaccines• Recognized in 2013 with Vaccine Industry Excellence Awards <strong>for</strong> Best Therapeutic Vaccine (<strong>for</strong>HPV-associated diseases) and Best Early Stage Biotech Company at World Vaccine Congress.Inovio (NYSE MKT: INO) is revolutionizing vaccines. With key potential investment catalysts ahead, weinvite <strong>you</strong> to learn more about our company, talk to us, and share our story.* * *This press release contains certain <strong>for</strong>ward-looking statements relating to our business, including our plans todevelop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources.Actual events or results may differ from the expectations set <strong>for</strong>th herein as a result of a number of factors, includinguncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but notlimited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of resultsachievable in other trials or <strong>for</strong> other indications, that the studies or trials may not be successful or achieve the resultsdesired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated,that results from one study may not necessarily be reflected or supported by the results of other similar studies andthat results from an animal study may not be indicative of results achievable in human studies), the availability offunding to support continuing research and studies in an ef<strong>for</strong>t to prove safety and efficacy of electroporationtechnology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, theavailability or potential availability of alternative therapies or treatments <strong>for</strong> the conditions targeted by the company orits collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatmentthat the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving productliability, issues involving patents and whether they or licenses to them will provide the company with meaningfulprotection from others using the covered technologies, whether such proprietary rights are en<strong>for</strong>ceable or defensibleor infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company canfinance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level ofcorporate expenditures, assessments of the company's technology by potential corporate or other partners orcollaborators, capital market conditions, the impact of government healthcare proposals and other factors set <strong>for</strong>th inour Annual Report on Form 10-K <strong>for</strong> the year ended December 31, 2012, our Form 10-Q <strong>for</strong> the quarter ended June30, 2013, and other regulatory filings from time to time. There can be no assurance that any product in Inovio'spipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive ofregulatory approvals required to market licensed products, or that any of the <strong>for</strong>ward-looking in<strong>for</strong>mation providedherein will be proven accurate.

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