Company Overview - Inovio Pharmaceuticals, Inc. (INO) is a biotechnology company focused on developing DNA therapeutics targeting HPV, oncology, and infectious diseases [1]. Technology and Innovation - The company utilizes CELLECTRA electroporation devices to facilitate the introduction of DNA into cells, enabling the body to produce specific proteins [1].

NEW YORK, Dec. 30, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Inovio Pharmaceuticals, Inc. (“Inovio” or the “Company”) (NASDAQ: INO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Inovio and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On Dece ...

Core Viewpoint - INOVIO's Biologics License Application (BLA) for INO-3107 has been accepted by the FDA for review as a potential treatment for adults with recurrent respiratory papillomatosis (RRP), with a standard review classification assigned [1][2] Group 1: FDA Review Process - The FDA has set a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, for INO-3107, indicating when it intends to take action on the application [2] - INOVIO filed the BLA under the accelerated approval pathway, although the FDA has raised concerns about the adequacy of information submitted for this pathway [3] Group 2: Clinical Data and Efficacy - INO-3107 has shown potential therapeutic benefits in clinical trials, with 72% of patients experiencing a 50-to-100% reduction in surgeries after one year of treatment, increasing to 86% in the second year without additional dosing [6][4] - The BLA is supported by data from a Phase 1/2 trial involving adult patients with RRP who had undergone multiple surgeries prior to treatment, demonstrating long-term clinical benefits [4][6] Group 3: Disease Background and Market Need - RRP is a rare disease primarily caused by HPV-6 and HPV-11, leading to the development of benign papillomas in the respiratory tract, which can cause severe complications [5] - Current standard care involves surgical removal of papillomas, but they often regrow, highlighting the need for effective non-surgical treatment options [5] Group 4: INO-3107 and its Mechanism - INO-3107 is designed to elicit a T cell response against HPV-6 and HPV-11, potentially preventing or slowing the growth of new papillomas [6][7] - The treatment has shown a strong immune response and was well tolerated in clinical trials, with mostly low-grade adverse effects reported [6][7] Group 5: Regulatory Designations and Market Access - INO-3107 has received Orphan Drug and Breakthrough Therapy designations from the FDA, as well as Orphan Drug designation from the European Commission [8] - The CELLECTRA delivery device has been CE-marked in the EU, allowing for commercialization in regions recognizing this certification [8]

Core Insights - Inovio is currently awaiting the acceptance of its Biologics License Application (BLA) for INO-3107, which targets recurrent respiratory papillomatosis [2] - The company is developing a unique pipeline and in vivo protein production technology, which has the potential to significantly surpass the market opportunity presented by recurrent respiratory papillomatosis [2] Company Overview - Inovio's leadership includes Jacqueline Shea, PhD, serving as President and CEO, and Michael Sumner as Chief Medical Officer [2] - The company is positioned in the biotech sector, focusing on innovative treatments and technologies [2]

Inovio Pharmaceuticals FY Conference Summary Company Overview - **Company**: Inovio Pharmaceuticals (NasdaqCM: INO) - **Focus**: Development of innovative therapies for HPV-related diseases, particularly recurrent respiratory papillomatosis (RRP) and other cancers. Key Points Industry and Disease Context - **Recurrent Respiratory Papillomatosis (RRP)**: - A rare disease caused by HPV types 6 and 11, leading to wart-like growths in the airways, affecting speech, swallowing, and breathing [3][4] - Current treatment involves repeated surgeries, which can lead to permanent vocal cord damage after multiple procedures [4] Product Development - **INO-3107**: - A DNA medicine delivered via a proprietary CELLECTRA device using electroporation, avoiding lipid nanoparticles or viral vectors [7][8] - Mechanism: Produces antigens targeting HPV E6 and E7 oncoproteins, generating cytotoxic T cells to destroy infected cells [9] - Clinical data shows a significant reduction in surgeries: - Median surgeries decreased from four to one in the first year post-treatment [11] - 28% of patients required no surgeries in the first year, increasing to 50% in the second year [11] Regulatory Status - **BLA Submission**: - Rolling submission completed on October 30, 2025, with expectations for acceptance feedback by year-end and a proposed PDUFA date in mid-2026 [13] Competitive Landscape - **Comparison with Precigen's PRGN-2012**: - PRGN-2012 is a gorilla-based adenoviral product requiring additional surgeries during treatment, contrasting with INO-3107's patient-centric approach [15][18] - Precigen's pricing is $115,000 per dose, totaling $460,000 for a four-dose regimen, excluding additional surgical costs [20] Market Potential - **Epidemiology**: - Estimated 14,000 active RRP cases in the U.S., with new cases at approximately 1.8 per 100,000 annually [22] - Inovio anticipates capturing a significant market share despite Precigen's entry, projecting single-digit penetration for Precigen in the first year [22] Future Development - **Pipeline Candidates**: - INO-3112 targeting HPV-positive head and neck cancers, with plans for a phase three trial [28] - INO-5401 for glioblastoma, also moving towards a randomized control trial [29] In Vivo Protein Production Technology - **Innovative Approach**: - Inovio's technology allows for the endogenous production of proteins, demonstrated with monoclonal antibodies against SARS-CoV-2, showing sustained production over 72 weeks [33] - Focus on long-term therapeutic protein production, with ongoing preclinical candidates [34][35] Financial Position - **Cash Reserves**: - Ended Q3 with approximately $51 million, with additional funds raising total cash to around $70 million, potentially reaching $100 million with warrant exercises [36][37] - Funds expected to support operations through the PDUFA date and facilitate launch preparations [37] Conclusion - Inovio Pharmaceuticals is positioned for a significant market entry with INO-3107, backed by promising clinical data and a robust pipeline, while navigating a competitive landscape with a focus on patient-centric treatment options [38]

Core Viewpoint - INOVIO Pharmaceuticals is preparing for two major investor conferences in December to showcase its strategic initiatives and engage with investors [1][6] Group 1: Upcoming Conferences - The first conference is the Piper Sandler 37th Annual Healthcare Conference on December 2 in New York, where INOVIO will participate in a fireside chat available via live webcast [2] - The second event is the Oppenheimer Movers in Rare Disease Summit on December 11, where INOVIO will join a panel discussing key near-term catalysts [3] Group 2: Stock Performance - INOVIO's stock price was $1.95 at the time of the Piper Sandler announcement but has decreased to $1.79, reflecting a 5.29% decline [2][3] - The stock has fluctuated between $1.78 and $1.90 on the day of reporting, with a market capitalization of approximately $95.93 million [4] - Over the past year, INOVIO's stock reached a high of $4.61 and a low of $1.30, with a trading volume of 1,073,702 shares on NASDAQ [5]

Core Insights - INOVIO, a biotechnology company, focuses on developing DNA medicines for HPV-associated diseases, cancer, and infectious diseases [1] Conference Participation - INOVIO will participate in the Piper Sandler 37th Annual Healthcare Conference on December 2, from 8:30 to 8:55 AM ET, featuring a fireside chat format [1] - The company will also attend the Oppenheimer Movers in Rare Disease Summit on December 11, from 12:05 to 12:25 PM ET, where it will present in a panel format focusing on rare disease companies with potential stock-moving catalysts [1] - INOVIO's management team will conduct one-on-one meetings with investors during these conferences [1]

Group 1 - The article does not provide any specific content related to a company or industry [1]

Core Viewpoint - Inovio Pharmaceuticals (INO) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which have a strong correlation with near-term stock price movements [4][6]. - Rising earnings estimates for Inovio suggest an improvement in the company's underlying business, likely leading to increased stock prices [5][10]. Zacks Rating System - The Zacks Rank stock-rating system categorizes stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7][9]. - Only the top 20% of Zacks-covered stocks receive a "Strong Buy" or "Buy" rating, indicating superior earnings estimate revisions [10]. Recent Earnings Estimate Revisions for Inovio - For the fiscal year ending December 2025, Inovio is expected to earn -$1.99 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 5% over the past three months [8].

Core Insights - Inovio Pharmaceuticals reported disappointing earnings for Q3 2025, with a GAAP EPS loss of -$0.87, which was $0.45 below consensus estimates [1] - The company's cash position at the end of the quarter was $50.8 million, which may impact its operational capabilities moving forward [1] Financial Performance - The reported GAAP EPS loss of -$0.87 indicates significant underperformance compared to market expectations [1] - The stock price reacted negatively, initially sliding by 12% following the earnings announcement [1] Cash Position - Inovio ended the quarter with $50.8 million in cash and cash equivalents, which is crucial for funding ongoing operations and research [1]