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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 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.
INOVIO (NASDAQ:INO) announced its participation in two major scientific conferences. At the 36th International Papillomavirus Conference in Edinburgh (Nov 12-15), the company will present research on INO-3107's treatment of recurrent respiratory papillomatosis, including studies on interferon responses and T-cell activity. At the Vaccines Summit in Boston (Nov 13-15), Dr. Dave Liebowitz will deliver a keynote on DNA Medicines Vaccine Platform, focusing on Ebola and respiratory papillomatosis case studies. All conference abstracts will be available on INOVIO's website after presentations.
INOVIO (NASDAQ: INO), a biotechnology company focused on DNA medicines for HPV-associated diseases, cancer, and infectious diseases, announced it will release its third quarter 2024 financial results after market close on November 14, 2024. The company will host a conference call and webcast at 4:30 p.m. ET on the same day, featuring a Q&A session with analysts. The webcast will be accessible at the company's investor relations website and will remain available for replay for 90 days.
INOVIO (NASDAQ:INO) presented new data for its lead candidate, INO-3107, at scientific conferences. The company is preparing a Biologics License Application for targeted submission in mid-2025 under the FDA's Accelerated Approval Pathway Program. New immunology data showed INO-3107's ability to induce antigen-specific T cell responses against HPV-6 and HPV-11 and drive T cell recruitment into airway tissues and papilloma of RRP patients.
In the Phase 1/2 trial, INO-3107 was well-tolerated and immunogenic. 81% of patients experienced a decrease in surgical interventions post-treatment compared to baseline. The overall clinical response was 81%, with 28% of patients requiring no surgical intervention during or after the dosing window. 44% of patients had a partial response, resulting in an overall response rate of 72%.
INO-3107 induced durable cellular responses and generated T cells against HPV-6 and HPV-11. The company believes these data demonstrate INO-3107's potential to significantly improve the lives of RRP patients.
INOVIO (NASDAQ:INO), a biotechnology company focused on DNA medicines for HPV-related diseases, cancer, and infectious diseases, has announced equity grants under its 2022 Inducement Plan. The Compensation Committee approved awards to two newly hired employees, including:
1. Restricted stock units (RSUs) covering 1,526 shares of common stock
2. Options to purchase 1,600 shares of common stock
The grants, dated September 30, 2024, include RSUs vesting over three years and stock options with an exercise price of $5.78. The stock options will vest in four installments, with one-fourth vesting immediately and the remainder annually over three years. Both RSUs and options are subject to continued employment and specific agreement terms under the Inducement Plan.
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