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Inovio Pharmaceuticals, Inc. (NASDAQ: INO) is a pioneering United States-based biotechnology company dedicated to combating cancers and infectious diseases through DNA medicines. The company's innovative approach harnesses active DNA-based immunotherapies and vaccines to both treat and prevent these conditions.
Inovio's core technology revolves around its DNA plasmids, which are small circular DNA molecules crafted to produce specific proteins to target and fight diseases, delivered via their proprietary CELLECTRA® electroporation devices. This technology enables the body to produce its own disease-fighting proteins and immune responses, without the need for traditional adjuvants or nanoparticles.
The company's flagship candidate, INO-3107, targets Recurrent Respiratory Papillomatosis (RRP), a chronic and rare disease caused by HPV-6 and HPV-11. Inovio has shown significant clinical progress with INO-3107, and after receiving Breakthrough Therapy designation and Orphan Drug designation from both the FDA and the European Commission, it is on track to submit a Biologics License Application (BLA) under the FDA's accelerated approval program. With successful clinical trials demonstrating a robust immune response and a reduction in the need for surgical interventions, INO-3107 stands as a potential game-changer for RRP patients.
In addition to INO-3107, Inovio's expansive product pipeline includes several other promising candidates in various stages of development. These include INO-3112 for HPV-16/18 positive head and neck cancer, INO-4201 as an Ebola vaccine booster, and INO-5401 for glioblastoma, showcasing the versatility and broad applicability of the company's DNA medicine platform.
Inovio has established numerous strategic partnerships and collaborations to enhance its research and development efforts. Key partners include Roche, MedImmune, the University of Pennsylvania, DARPA, Drexel University, NIH, and the U.S. Military HIV Research Program. These collaborations not only bolster Inovio's scientific capabilities but also facilitate the swift advancement of its clinical programs.
Financially, Inovio has maintained a disciplined approach to managing its resources. The company recently projected its cash runway to extend into the second quarter of 2025, following positive feedback from the FDA on the accelerated approval pathway for INO-3107. This financial stability is crucial as Inovio prepares for potential commercialization of its lead candidates.
Inovio's commitment to innovation and its effective strategic execution position it as a formidable player in the biopharmaceutical industry, dedicated to bringing groundbreaking DNA medicine solutions to market. For more information, visit www.inovio.com.
INOVIO (NASDAQ: INO) announced that CEO Dr. Joseph Kim will participate in a fireside chat and 1x1 meetings at Oppenheimer's 32nd Annual Healthcare Conference on March 15, 2021, at 8:00 AM ET. The event will focus on the company's work in developing DNA medicines for infectious diseases and cancer treatments, including Phase 3 trials for VGX-3100 and INO-4800, a COVID-19 vaccine. A webcast of the presentation can be accessed via the INOVIO Investor Relations page.
INOVIO (NASDAQ: INO) reported financial results for Q4 and year-end 2021, with total revenue of $839,000 and $1.8 million respectively, down from $5.6 million and $7.4 million in 2020. The net loss widened to $106.9 million, or $0.50 per share, compared to a net loss of $24.3 million the previous year. Key developments include ongoing clinical trials for COVID-19 vaccine INO-4800, with plans to amend its Phase 3 trial endpoint to focus on severe disease. Other advancements include completed enrollments for various therapeutic programs, highlighting INOVIO's commitment to combating infectious diseases and cancer.
INOVIO (NASDAQ: INO) will announce its fourth quarter 2021 financial results after market close on March 1, 2022. A live conference call is scheduled for 4:30 p.m. ET to discuss these results and provide a general business update. INOVIO focuses on DNA medicines targeting infectious diseases and cancers, currently evaluating VGX-3100 for cervical dysplasia and INO-4800 as a COVID-19 vaccine in Phase 3 trials. Investors can access the call and archived audio on their website.
INOVIO (NASDAQ: INO) announced key updates on the Phase 3 program for VGX-3100, an immunotherapy targeting HPV-associated cervical high-grade squamous intraepithelial lesions (HSIL). The second global trial, REVEAL2, has completed enrollment, with top-line results expected in 2H22. REVEAL1's follow-up showed a favorable safety profile and continued efficacy at 88 weeks. Additionally, the first participant has been dosed in a separate Phase 3 trial in China, and INOVIO is collaborating with QIAGEN to develop a pre-treatment biomarker to enhance clinical outcomes.
INOVIO (NASDAQ: INO) announced its rapid evaluation of COVID-19 DNA vaccines INO-4800 and INO-4802 against the Omicron variant (B.1.1.529). The company has initiated pre-clinical development of an Omicron-specific DNA vaccine. INO-4800 has shown T cell responses, suggesting resilience against variant mutations, with data expected soon. Dr. Joseph Kim emphasized INO-4800's strong immune response, citing its potential against current and future variants. The vaccine's stability at room temperature supports its global deployment.
INOVIO (NASDAQ: INO) has initiated a Phase 1b clinical trial for its Ebola vaccine candidate, INO-4201, with several volunteers already dosed. The study assesses INO-4201 as a potential booster for individuals previously vaccinated with Ervebo. Preclinical results indicated strong tolerability and 100% seroconversion after two doses. The trial will involve around 50 participants, evaluating safety and immunogenicity. Notably, INO-4201 offers advantages in stability and storage, essential for use in tropical environments.
INOVIO (NASDAQ:INO) announced it will give eight presentations at the 34th International Papillomavirus Conference from November 15-19, 2021. Key topics include updates from the VGX-3100 clinical trials, which are in Phase 3 for cervical high-grade lesions and Phase 2 for anal and vulvar HSIL. Additionally, the study on INO-3107 for recurrent respiratory papillomatosis will be shared. Collaborations with Optum Life Sciences will present data on the epidemiology and treatment effectiveness for HSIL in the U.S. This event highlights INOVIO's ongoing commitment to HPV-related diseases and immune response development.
INOVIO (NASDAQ:INO) reported its Q3 2021 financial results, showing total revenue of $292,000, up from $236,000 in Q3 2020. The company faced significant operating expenses of $60.2 million, resulting in a net loss of $60.2 million, or $0.29 per share. Key highlights include FDA authorization for its INO-4800 COVID-19 vaccine's Phase 3 trial and progress in global trials across various countries. The company also completed enrollment for its INO-4500 Lassa fever vaccine trial in West Africa. Interim efficacy data for INO-4800 is anticipated in H1 2022.
INOVIO (NASDAQ: INO) has received FDA authorization to proceed with the INNOVATE Phase 3 segment for its COVID-19 vaccine candidate, INO-4800, in the U.S. Following a review of additional information, the FDA lifted a partial clinical hold. This global Phase 3 trial aims to evaluate INO-4800's efficacy in a two-dose regimen among adults 18 years and older. The vaccine, which is notable for its stability and shelf life, is being developed to provide a robust immune response against SARS-CoV-2.
INOVIO (NASDAQ: INO) has appointed four new leaders to strengthen its executive team ahead of commercial operations. Mark Twyman takes on the role of Chief Commercial Officer, Rob Crotty as General Counsel, Asli Gevgilili as Chief Human Resources Officer, and Gene Kim as Chief Corporate Affairs Officer. These appointments aim to leverage their extensive experience in the biotech and pharmaceutical industries to expedite the launch of INOVIO's DNA medicines targeting infectious diseases and cancer. The company is also advancing clinical trials for its vaccine candidates, including INO-4800 against COVID-19.
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