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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 promising results from a Phase 1b trial evaluating INO-4201 as a booster for the rVSV-ZEBOV vaccine presented at the 33rd ECCMID. Conducted by Geneva University Hospitals, the trial demonstrated that INO-4201 was well tolerated and generated a robust immune response. Preliminary data indicated that 100% of participants exhibited increased humoral responses, with significant antibody titer boosts observed after vaccination. Geometric mean titers rose markedly after booster administration, indicating potential effectiveness against Zaire ebolavirus. These developments position INO-4201 as a crucial addition to strategies against Ebola Virus Disease, highlighting its significance in public health initiatives against infectious diseases.
INOVIO (NASDAQ: INO) announced that an abstract for its DNA vaccine candidate INO-4201 has been accepted for presentation at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) on April 16, 2023. This Phase 1b trial focuses on the vaccine as a booster for the rVSV-ZEBOV (Ervebo) Ebola vaccine. Lead investigator Dr. Angela Huttner will present new humoral and cellular response data during a late-breaking trial session. The trial, involving 46 participants, evaluated the safety, tolerability, and immunogenicity of INO-4201, which targets the Zaire Ebola virus and aims to enhance immune response against various ZEBOV strains. This research is significant as Ebola remains a critical health threat with ongoing outbreaks.
INOVIO (NASDAQ: INO) announced on April 3, 2023, an equity grant to its new Senior Vice President of Regulatory Affairs under the 2022 Inducement Plan. The Compensation Committee approved the award of 45,000 restricted stock units (RSUs) and options for 70,000 shares with a grant date of March 31, 2023. RSUs will vest over three years, while stock options have an exercise price of $0.82, matching the closing stock price on the grant date. The options will vest in phases, contingent on the employee's continued employment. This initiative aligns with INOVIO’s focus on developing DNA medicines against HPV-associated diseases and cancer.
INOVIO (NASDAQ: INO), a biotechnology firm focused on DNA medicines for HPV-related diseases, cancer, and infectious diseases, announced that Jacqueline Shea, Ph.D., CEO, will present at the Oppenheimer 33rd Annual Healthcare Conference on March 13, 2023, at 10:40 AM ET.
Dr. Shea and the management team will engage in one-on-one meetings with investors. A webcast of the presentation will be available on the INOVIO Investor Relations Events page, with a replay accessible for 90 days post-event. INOVIO's innovative approach includes using the CELLECTRA® device to generate immune responses against targeted health threats.
INOVIO (NASDAQ: INO) announced topline results from the Phase 3 REVEAL2 trial of VGX-3100 for cervical HSIL, where it did not meet the primary endpoint in a biomarker-selected group but showed statistical significance in the all-participants population. The company reported a fourth-quarter 2022 revenue of $125,000 against total operating expenses of $56.1 million, leading to a net loss of $54.5 million. Despite challenges, INOVIO ended 2022 with $253 million in cash, sufficient to fund operations into Q1 2025. Positive preliminary data were also presented for INO-3107 and INO-4201, suggesting potential in HPV and Ebola treatment domains.
INOVIO (NASDAQ: INO) announced positive preliminary results from the second cohort of its Phase 1/2 clinical trial for INO-3107, aimed at treating HPV 6 and HPV 11-associated Recurrent Respiratory Papillomatosis (RRP). Of 11 patients, 10 (91%) experienced a reduction in surgical interventions, with a statistically significant median decrease of three surgeries compared to the previous year. The treatment was well-tolerated, and results aligned with the first cohort. The trial's successful outcomes may pave the way for further regulatory engagement and potential advancements in DNA medicine therapies.
INOVIO (NASDAQ: INO) announced that it will release its fourth quarter and year-end 2022 financial results on March 1, 2023, after market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide a business update. The company is focused on developing DNA medicines for HPV-associated diseases and cancer, utilizing its proprietary CELLECTRA® device. Details for accessing the live event and archived presentation are available on their investor relations website.
INOVIO (NASDAQ: INO) announced the equity grant of stock options to a new employee under its 2022 Inducement Plan on February 2, 2023. The Board's Compensation Committee approved the award of options to purchase 15,625 shares at an exercise price of $1.79, reflecting the stock's closing price on the Grant Date. The options will vest over four years, contingent upon continued employment. INOVIO focuses on DNA medicines to treat HPV-associated diseases, cancer, and infectious diseases through its proprietary device, CELLECTRA®.
INOVIO (NASDAQ: INO) announced positive results from a Phase 1b clinical trial of INO-4201, a DNA vaccine candidate as a booster for individuals previously vaccinated with Ervebo. Conducted with 46 participants, the trial demonstrated that INO-4201 was well-tolerated and boosted humoral responses in 100% of treated subjects (36 of 36). Neutralizing titers were significantly higher in the INO-4201 group compared to placebo, with responses maintained even 24 weeks later. The trial was sponsored by Geneva University Hospitals and funded by DARPA. The results emphasize the potential of INO-4201 for future Ebola Virus Disease prevention.
INOVIO (NASDAQ: INO) announced a strategic reorganization aimed at enhancing operational efficiency and advancing its DNA medicine programs. Key elements include an 11% reduction in headcount, expected to yield annual savings of approximately $4.3 million, and a one-time restructuring charge of around $1.1 million anticipated in Q1 2023. The reorganization follows the discontinuation of certain clinical development programs in late 2022. INOVIO confirmed that data readouts for its product candidates, INO-3107 and VGX-3100, are projected for the first quarter of 2023, aligning with its focus on HPV-associated diseases.
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