Inovio Reports First Quarter 2007 Financial Results.SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. -- Inovio Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. Corporation (AMEX AMEX See: American Stock Exchange : INO Ino (ī`nō), in Greek mythology, daughter of Cadmus. She was the wife of Athamas, to whom she bore Learchus and Melicertes. She plotted to kill her stepchildren, Phrixus and Helle, but their mother, Nephele, saved them with the help of a winged ) today reported financial results for the three months ended March 31, 2007. Total revenue for the three months ended March 31, 2007 was $503,902, as compared to $697,993 for the same period in 2006. Revenue consisted of license fees, milestone payments, revenue recognized from collaborative research and development arrangements and grants. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the three months ended March 31, 2007 were $4,807,572, as compared to $3,510,975 for the three months ended March 31, 2006. The net loss attributable to common stockholders for the three months ended March 31, 2007 was $(4,085,907), or $(0.11) per share, as compared with a net loss attributable to common stockholders of $(2,706,225), or $(0.09) per share, for the three months ended March 31, 2006. Revenue Revenue from license fees and milestone payments was $234,489 for the three months ended March 31, 2007, as compared to $151,054 for the three months ended March 31, 2006. The increase in revenue from license fees and milestone payments for the three month period ended March 31, 2007 as compared to the comparable period in 2006, was mainly due to the recognition of revenue from a licensing agreement with Wyeth. Revenue from collaborative research and development arrangements during the three months ended March 31, 2007 was $247,990, as compared to $276,230 for the same period in 2006. This decrease in revenue was primarily due to less collaborative research and development revenue recognized from our agreement with Merck. Grant and miscellaneous revenue was $21,423 for the three months ended March 31, 2007, as compared to $270,709 for the three months ended March 31, 2006. The decrease in grant and miscellaneous revenue for the three months ended March 31, 2007, as compared to the comparable period in 2006, was mainly attributable to less revenue recognized from our European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community and U.S. Army grants due to the finalization of work performed. Operating Expenses Research and development expenses for the three months ended March 31, 2007 were $2,516,411, as compared to $1,640,425 for the three months ended March 31, 2006. The increase in research and development expenses for the three months ended March 31, 2007 as compared to the comparable period in 2006, was primarily due to an increase in clinical trial expenses due to higher patient enrollment, new clinical sites, data collection and data monitoring costs and increased costs related to the use of outside Clinical Research Organizations ("CRO's") and Clinical Research Associates ("CRA's"). These were offset by a decrease in outside lab testing performed in connection with the U.S. Army grant. General and administrative expenses for the three months ended March 31, 2007 were $2,234,911, as compared to $1,814,300 for the three months ended March 31, 2006. The increase in general and administrative expenses for the three months ended March 31, 2007 as compared to the comparable period in 2006, was mainly due to increased legal fees associated with intellectual property and business development, increased personnel expenses associated with expanding our in-house expertise, an increase in outside investor relations Investor relations The process by which the corporation communicates with its investors. services associated with our DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. and gene therapy program, and an increase in travel and transportation expenses related to investor relations and business development efforts. Amortization of intangible assets was $56,250 during the three months ended March 31, 2007 and 2006, related to an intangible asset associated with contracts and intellectual property we acquired as part of our purchase of Inovio AS. Net Loss Attributable to Common Stockholders The increase in net loss attributable to common stockholders for the three months ended March 31, 2007, as compared to the same period in 2006, resulted mainly from the decrease in revenue and increase in operating expenses as described above. Capital Resources As of March 31, 2007, we had cash and short-term investments of $19,033,607 and working capital of $17,724,733, as compared to $23,021,606 in cash and short-term investments and $21,152,908 in working capital as of December 31, 2006. The decrease in working capital during the three months ended March 31, 2007 was primarily due to expenditures related to our research and development and clinical trial activities, as well as various general and administrative expenses related to legal, corporate development and investor relations activities. Corporate Update In 2007, to date we have presented at multiple investor and scientific conferences with the objective of expanding recognition and interest in Inovio with investors and prospective collaborators. Notably, partners and clinical collaborators have also presented data relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc Inovio's Selective Electrochemical electrochemical /elec·tro·chem·i·cal/ (-kem´i-k'l) pertaining to interaction or interconversion of chemical and electrical energies. e·lec·tro·chem·i·cal adj. Tumor Ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. (SECTA) therapy or its DNA-based immunotherapy program. For example, Wyeth published and presented pre-clinical data indicating that the use of Inovio's DNA delivery technology in conjunction with their DNA vaccine against HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. increased the potency of the immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. in monkeys by over 200 times, a result that they noted had "important implications for the design and development of an efficacious therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. for the treatment of HIV-1 infection." In addition, Merck published and presented data indicating that the use of Inovio's DNA delivery system was tolerable in patients without the use of anesthetic. We believe this is a positive result suggesting that immunotherapies delivered using Inovio's system could have wider acceptance and broader applicability compared to an approach requiring the use of anesthetic. We have been invited to multiple scientific conferences over the next months and anticipate the release at one or more of these conferences of preliminary data from some of the first-in-man studies using our technology to deliver DNA-based immunotherapies. We expanded enrollment of sites and patients in Europe for our two pre-marketing clinical studies - one treating patients with newly diagnosed or recurrent squamous cell carcinomas squamous cell carcinoma n. A carcinoma that arises from squamous epithelium and is the most common form of skin cancer. Also called cancroid, epidermoid carcinoma. of the head and neck, the other treating patients with newly diagnosed or recurrent skin cancers requiring potentially disfiguring surgery disfiguring surgery A popular term for surgery that mutilates, especially if it affects the face, hands and arms; the term mutilating surgery generally refers to other body regions . We anticipate achieving enrollment targets for the head and neck study by mid-2007 and the skin study by the end of the third quarter. In our Selective Electrochemical Tumor Ablation (SECTA) program, we completed enrollment of our Phase I/II study treating patients with recurrent breast cancer with a primary endpoint of safety and a secondary endpoint of tumor response. We are currently assessing potential scientific conferences at which to release results from this study. About Inovio Biomedical Corporation Inovio Biomedical Corporation is focused on commercializing its Selective Electrochemical Tumor Ablation (SECTA) therapy and development of multiple DNA vaccines using its delivery platform for gene-based treatments. SECTA is a local ablation therapy ablation therapy See Ablation–cardiology. for solid tumors that is designed to selectively kill cancerous cells and minimize cosmetic or functional impacts to predominantly healthy tissue typically treated around the tumor. Inovio is moving its lead product, the MedPulser[R], through pre-marketing studies for head and neck cancer and skin cancers in Europe, where it has CE Mark accreditation, a U.S. phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA pivotal study for head and neck cancer, and a phase I/II trial for breast cancer. Inovio's DNA delivery partners include Merck, Wyeth, Vical, University of Southampton In the most recent RAE assessment (2001), it has the only engineering faculty in the country to receive the highest rating (5*) across all disciplines.[3] According to The Times Higher Education Supplement , Moffitt Cancer Center, and the U.S. Army, with four gene-based therapies and DNA vaccines in phase I clinical studies. Inovio is a leader in developing human therapeutic applications of electroporation electroporation (i·lekˈ·trō·p  ·rāˑ·sh , which uses brief, controlled electrical pulses to
dramatically increase cellular uptake of a useful biopharmaceutical,
with the industry's most extensive patent portfolio covering in
vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. electroporation. More information is available at www.inovio.com. This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology and about the availability of supporting internet technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans); the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism; the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop; evaluation of potential opportunities; issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies; whether such proprietary rights are enforceable or defensible de·fen·si·ble adj. Capable of being defended, protected, or justified: defensible arguments. de·fen or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend its proprietary rights; the level of corporate expenditures; assessments of our technology by potential corporate or other partners or collaborators; capital market conditions; and other factors set forth in the our Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2006, our Form 10-Q Form 10-Q See 10-Q. for the three months ended March 31, 2007, and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products. [TABLE OMITTED] [TABLE OMITTED] |
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