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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 peer-reviewed data from its Phase 1/2 clinical trial of INO-3107 for treating recurrent respiratory papillomatosis (RRP) in Nature Communications. The trial demonstrated significant clinical benefits, with 81.3% (26/32) of patients requiring fewer surgeries post-treatment compared to the previous year. 28.1% (9/32) of patients achieved Complete Response, requiring no surgical intervention.
The treatment showed strong safety profile with only 41% reporting treatment-related adverse events, mostly mild injection site pain (31%) and fatigue (9%). INO-3107 induced lasting T cell responses specific to HPV-6 and HPV-11, with evidence of immune cells traveling to affected tissues.
INOVIO plans to submit its biologics license application (BLA) in mid-2025, seeking rolling submission and priority review. If approved, INO-3107 would become the first DNA medicine approved in the United States.
INOVIO (NASDAQ:INO) announced that it will present immunological activity data for INO-3107 at the American Association for Cancer Research – Immuno-Oncology Discovery and Innovation in Cancer Immunology conference, scheduled for February 23-26, 2025. The poster presentation will focus on the loss of detectable HPV-6 in Recurrent Respiratory Papillomatosis patients following INO-3107 treatment, specifically highlighting the induction of emergent T cells in patients who showed durable complete clinical response. The abstract will be made available on INOVIO's website after the conference.
INOVIO (NASDAQ: INO), a biotechnology company specializing in DNA medicines for HPV-associated diseases, cancer, and infectious diseases, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference.
The company's President and CEO, Dr. Jacqueline Shea, along with Chief Medical Officer Dr. Michael Sumner, will deliver a presentation on Wednesday, February 12, 2025, from 3:20 to 3:50 PM ET. The management team will also conduct one-on-one meetings with registered investors during the conference.
Interested parties can access the presentation through a webcast available on INOVIO's Investor Relations Events page, with replay access available for 90 days following the presentation.
INOVIO highlighted its anticipated 2025 milestones and 2024 achievements. The company plans to submit a biologics license application (BLA) for INO-3107 by mid-2025 for treating recurrent respiratory papillomatosis (RRP). Key 2024 accomplishments include positive durability data showing 50% of RRP patients achieved complete response requiring no surgery by year two, with 88% maintaining complete response through year two and 63% into year three.
The company expects to initiate a confirmatory trial at 20 U.S. academic centers with approximately 100 patients. INOVIO strengthened its financial position with over $60 million from equity offerings in 2024, reporting $84.4 million in cash and equivalents as of September 2024. The company is also progressing with INO-3112 for HPV-related cancer and other pipeline products including INO-4201 for Ebola and DNA monoclonal antibody programs.
INOVIO Pharmaceuticals (Nasdaq: INO) has announced the pricing of a $30 million public offering, consisting of 10,000,000 shares of common stock and accompanying warrants. The combined offering is priced at $3.00 per share with warrants exercisable at $3.76 per share. The offering, expected to close on December 16, 2024, is being managed by Oppenheimer & Co. Inc. and Citizens JMP as joint book-running managers, with Stephens Inc. as lead manager. The gross proceeds of $30 million are calculated before deducting underwriting discounts, commissions, and offering expenses.
INOVIO Pharmaceuticals (Nasdaq: INO) announced plans for a proposed public offering of common stock and accompanying warrants. The biotechnology company, focused on DNA medicines for HPV-related diseases, cancer, and infectious diseases, will sell all securities in the offering. Oppenheimer & Co. Inc. and Citizens JMP are serving as joint book-running managers, with Stephens Inc. as lead manager.
The offering is subject to market conditions, with no guarantees regarding completion, size, or terms. It will be conducted under a shelf registration statement filed with the SEC on November 9, 2023, and declared effective on January 31, 2024.
INOVIO announced promising data from a retrospective trial of INO-3107 for Recurrent Respiratory Papillomatosis (RRP). The trial showed increased Complete Response rates among patients, rising from 28% at the end of the initial 52-week trial to 50% by year 2 and 54% by year 3. 95% of patients maintained or enhanced their Original Response Rate by year 2, with 86% maintaining improvements into year 3. The durability data will inform re-dosing strategies and support INOVIO's BLA submission planned for mid-2025. No treatment-emergent serious adverse events were identified during the retrospective trial.
INOVIO (NASDAQ:INO) announced an equity grant under its 2022 Inducement Plan for a newly hired employee. The Compensation Committee approved a stock option award of 1,666 shares with a grant date of November 30, 2024. The option has an exercise price of $4.32, based on the closing price on November 29, 2024. The stock option will vest in four equal installments: one-fourth on the grant date and additional one-fourth portions on the first, second, and third anniversaries, subject to continued employment.
INOVIO reported Q3 2024 financial results and updates on INO-3107 development for RRP treatment. New immunology data showed INO-3107's ability to induce T cell responses against HPV-6 and HPV-11. The Phase 1/2 trial demonstrated 81% clinical response rate, with 28% of patients requiring no surgical intervention. Financial highlights include cash position of $84.8M, R&D expenses of $18.7M, and net loss of $25.2M. The company targets BLA submission for mid-2025, with all non-device modules expected to be completed by end of 2024. Cash runway is projected into Q3 2025.
INOVIO announced new immunology data supporting the clinical activity of INO-3107 in treating recurrent respiratory papillomatosis (RRP). The data shows INO-3107 induced expansion of new clonal T cells in blood that weren't detectable before treatment. These cells traveled to papilloma and airway tissues, generating an inflammatory and anti-viral response consistent with reduced surgery needs for RRP patients with HPV-6 and HPV-11. The Phase 1/2 trial's immunological testing demonstrated the drug's ability to induce T cell responses specific to HPV-6 and HPV-11, including cytotoxic CD8+ T cells present at week 52, indicating memory response establishment.
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