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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), a biotechnology company focused on DNA medicines, announced that the European Medicines Agency's Committee for Advanced Therapies (CAT) has certified the quality and non-clinical data for INO-3107, their lead candidate for treating Recurrent Respiratory Papillomatosis (RRP). This certification confirms that INOVIO's chemistry, manufacturing and controls (CMC) data and nonclinical results comply with the scientific and technical standards used for evaluating a European Marketing Authorization Application.
The CAT certification provides an opportunity to identify potential development issues before submitting a Marketing Authorization Application, particularly beneficial for small and medium-sized enterprises. This regulatory achievement validates INOVIO's efforts to bring INO-3107 to RRP patients globally and demonstrates their development team's adherence to high standards.
INOVIO (NASDAQ:INO), a biotechnology company specializing in DNA medicines for HPV-associated diseases, cancer, and infectious diseases, has announced its plans to release second quarter 2024 financial results on August 8, 2024, after the market close. The company will host a live conference call and webcast at 4:30 p.m. ET on the same day to discuss the financial results and provide a general business update. The event will include a live Q&A session with analysts. Investors and interested parties can access the webcast through INOVIO's investor relations website. The webcast will be archived and available for replay for 90 days following the event.
INOVIO (NASDAQ: INO) has announced that its lead DNA medicine candidate, INO-3107, has been awarded the Innovation Passport designation under the U.K.'s Innovative Licensing and Access Pathway (ILAP). This designation is given to innovative medicines with the potential to meet a significant unmet medical need, accelerating their development and regulatory approval process.
INO-3107 is targeted at treating Recurrent Respiratory Papillomatosis (RRP), a rare and chronic disease caused by HPV-6 and HPV-11. The Innovation Passport facilitates a streamlined roadmap for regulatory approval, offering opportunities for enhanced regulatory input and accelerated timelines.
The ILAP, driven by multiple U.K. health authorities, aims to expedite the availability of promising medicines, particularly benefiting the post-Brexit life sciences landscape.
INOVIO announced the appointment of Steven Egge as Chief Commercial Officer, effective immediately. Bringing over 25 years of biopharmaceutical experience, Egge will spearhead INOVIO's commercial strategy as it moves towards becoming a commercial-stage company. The company plans to submit a Biologics License Application (BLA) for INO-3107 for recurrent respiratory papillomatosis (RRP) in the latter half of 2024 under the FDA's Accelerated Approval Pathway. This strategic hire aims to leverage Egge's extensive background in launching novel therapeutic products and building commercial organizations. His prior roles include key positions at Sumitomo Pharma and Merck, where he successfully led various product launches and market expansions.
INOVIO (NASDAQ: INO), a biotechnology company specializing in DNA medicines, announced an equity grant under its 2022 Inducement Plan. The grant comprises an option to purchase 1,400 shares of common stock, priced at $8.08 per share, which matches the stock's closing price on June 28, 2024. The grant was approved by INOVIO's Compensation Committee and issued to a newly hired employee as of June 30, 2024. The stock options will vest and become exercisable over four years, contingent on the employee's continued employment. This grant aligns with Nasdaq Listing Rule 5635(c)(4).
INOVIO (NASDAQ: INO), a biotechnology company, has been added to the Russell 2000® Index effective July 1, 2024. This inclusion is part of the annual reconstitution of the Russell stock indexes, which became effective after markets closed on June 28, 2024. INOVIO's CEO, Dr. Jacqueline Shea, noted that the last year has been transformational for the company, highlighting advancements with their lead candidate INO-3107 for RRP. The company plans to submit a BLA for INO-3107 under the FDA's accelerated approval pathway in late 2024 and aims for a commercial launch in 2025, pending approval. INOVIO is also progressing with other candidates like INO-3112 for head and neck cancer, INO-5401 for GBM, and INO-4201 as an Ebola vaccine booster. The Russell US Indexes, managed by FTSE Russell, capture the 4,000 largest U.S. stocks by market capitalization, with $10.5 trillion in assets benchmarked against them as of December 2023.
INOVIO (NASDAQ: INO) announced its participation in a virtual fireside chat hosted by Stephens, Inc. The event, featuring INOVIO's President and CEO Dr. Jacqueline Shea and Chief Medical Officer Dr. Michael Sumner, will take place on June 11, 2024, at 11:00am ET. The discussion will be moderated by Sudan Loganathan, Ph.D., Managing Director and equity research analyst at Stephens. This session is exclusive to institutional clients of Stephens.
INOVIO (NASDAQ:INO), a biotechnology company developing DNA medicines for HPV-related diseases, cancer, and infectious diseases, announced an equity grant under its 2022 Inducement Plan. The grant, approved by INOVIO's Compensation Committee, involves options to purchase 1,666 shares at $10.13 per share, the closing price on May 31, 2024. The options vest over three years, contingent on continued employment.
INOVIO (NASDAQ: INO) reported its Q1 2024 financial results and recent business highlights. The company is on track to submit a BLA for INO-3107 in the second half of 2024, aiming to become the first non-surgical treatment for recurrent respiratory papillomatosis (RRP). A confirmatory trial for INO-3107 is planned, with FDA feedback incorporated. INOVIO also plans a Phase 3 trial of INO-3112 in combination with LOQTORZI for treating HPV-16/18 positive oropharyngeal squamous cell carcinoma (OPSCC).
Financially, INOVIO's cash, equivalents, and short-term investments stood at $105.6 million as of March 31, 2024, down from $145.3 million in December 2023. The company completed a $33.2 million stock and pre-funded warrants offering in April 2024, extending its cash runway to Q3 2025. Q1 R&D expenses decreased from $30.2 million in 2023 to $20.9 million, while G&A expenses dropped from $13.9 million to $10.6 million. The net loss improved to $30.5 million ($1.31 per share) from $40.6 million ($1.89 per share) in Q1 2023, following a reverse stock split in January 2024.
INOVIO, a biotechnology company, granted equity awards to two new employees under its 2022 Inducement Plan. The awards include restricted stock units and stock options, with vesting over a three-year period. The grants aim to incentivize and retain talent as part of the company's strategic growth.
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