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]

PLYMOUTH MEETING, Pa. , Nov. 18, 2025 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, today announced that it will participate in the following investor conferences: Piper Sandler 37th Annual Healthcare Conference (New York, NY) Date: Tuesday, December 2 Time: 8:30-8:55 AM ET Format: Fireside Chat Webcast:  https://bit.ly/44af19l (live webcast ...

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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]

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Financial Data and Key Metrics Changes - Operating expenses decreased from $27.3 million in Q3 2024 to $21.2 million in Q3 2025, a 22% reduction [19] - Net loss for the quarter increased to $45.5 million, or $0.87 per share, primarily due to a $22.5 million non-cash loss on fair value adjustments related to warrant liabilities [20] - Loss from operations decreased 22% to $21.2 million in Q3 2025 from $27.3 million in Q3 2024, with a per-share loss dropping 58% to $0.41 from $0.97 [21][22] Business Line Data and Key Metrics Changes - The primary focus remains on the development of INO 3107, with significant progress in regulatory submissions and preparations for a potential launch [5][19] - The company is advancing next-generation DNA medicine candidates, including DMAP and DPROT technologies, which have shown promising results in clinical and preclinical studies [6][24] Market Data and Key Metrics Changes - The company anticipates a potential PDUFA date for INO 3107 around mid-2026, following the expected acceptance of the BLA submission by the FDA by year-end 2025 [5][8] - Market research indicates that INO 3107 has a differentiated product profile that appeals to both physicians and patients, with a significant reduction in surgeries reported [15][16] Company Strategy and Development Direction - The company aims to position INO 3107 as a preferred treatment for RRP patients, emphasizing its advantages over competitors, particularly regarding the treatment regimen and reduced need for surgeries [6][10] - The company is also exploring partnerships and development opportunities to advance its pipeline beyond INO 3107, including INO 3112 and INO 5401 [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of INO 3107 to meet significant unmet needs in the RRP community, highlighting the importance of reducing the number of surgeries required [10][12] - The company is preparing for a swift launch of INO 3107 if approved, with ongoing market research and operational preparations [18][19] Other Important Information - The company has completed the rolling submission of its BLA for INO 3107, marking a significant milestone in its development efforts [5][8] - The company has a cash balance of $50.8 million as of the end of Q3 2025, with an estimated cash runway into the second quarter of 2026 [22] Q&A Session Summary Question: Has Pepcimios officially launched, and how significant is their head start? - Pepcimios became available to order as of October 21, and the company expects single-digit penetration into the prevalent population before their own expected approval in mid-2026 [26][27] Question: Will INO 3107 have a similar label to Pepcimios, and is a pivotal study required for ex-U.S. approval? - The company believes their data would justify a broad label similar to Pepcimios, and any confirmatory study will be valuable for European filings [31][33][38] Question: What is the Salesforce preparedness post-3107 approval? - The company is advancing launch preparations and plans to have a field force ready to engage in scientific exchange and payer discussions ahead of approval [42] Question: Are there any cross-reactivity issues for patients switching from Pepcimios to INO 3107? - There is no anticipated cross-reactivity issue, but patients will need to complete the entire treatment regimen of INO 3107 [45] Question: Can you comment on the levels of expression achieved for the dMAb technology? - The company reported sustained expression of monoclonal antibodies over 72 weeks, with concentrations in the blood exceeding 1 microgram per ml, indicating promising results [49][50]

INO-3107 Program & Regulatory Updates - INOVIO completed the rolling BLA submission for INO-3107, seeking accelerated approval, with file acceptance expected by the end of the year[11] - If Priority Review is granted, a potential PDUFA date in mid-2026 is anticipated[11, 44] - The company has requested a Type D meeting with the FDA to discuss options for the confirmatory trial design[13] - In a Phase 1/2 trial, 72% of patients saw a 50-100% reduction in surgeries in Year 1[14] - A retrospective trial (RRP-002) showed clinical outcomes maintained or improved upon through year 2 and into year 3 with no additional dosing[14] - Mean surgeries per year decreased by 78% from pre-treatment Year -1 (4.1 surgeries) to Year 2 (0.9 surgeries)[16] Commercialization & Financials - Market research supports a preferred product profile for INO-3107, with 72% overall response rate (50% to 100% reduction in surgeries) in year 1 and 86% in year 2[27] - Operating expenses decreased by 22% to $212 million for the three months ended September 30, 2025, compared to $273 million in 2024[33] - Net loss for the three months ended September 30, 2025, was $455 million, which includes a non-cash loss on fair value adjustment of common stock warrant liabilities of $225 million[33] - Cash, cash equivalents, and short-term investments totaled $508 million as of September 30, 2025, providing a cash runway projected into 2Q 2026[34]

Clinical Development - INOVIO completed the rolling submission of its Biologics License Application (BLA) for INO-3107, seeking accelerated approval with a potential PDUFA date in mid-2026[4] - 81% of patients experienced a reduction in surgeries at Year 1 post-treatment with INO-3107, increasing to 91% by the end of Year 2[12] - INO-3107 demonstrated a 78% reduction in mean annual surgeries at Year 2 compared to the pre-treatment period (0.9 vs 4.1 surgeries)[12] Financial Performance - Net loss for Q3 2025 increased to $45.5 million, or $0.87 per share, compared to a net loss of $25.2 million, or $0.89 per share, in Q3 2024[14] - Revenue from collaborative arrangements for the nine months ended September 30, 2025, was $65,343,000, a decrease from $100,762,000 in the same period of 2024[27] - The net loss for the three months ended September 30, 2025, was $45,496,672, compared to a net loss of $25,165,478 in 2024, reflecting an increase in losses of approximately 81%[27] - Basic and diluted net loss per share for the nine months ended September 30, 2025, was $2.12, an improvement from $3.35 in the same period of 2024[27] Expenses - Research and Development (R&D) expenses decreased to $13.3 million in Q3 2025 from $18.7 million in Q3 2024, primarily due to lower drug manufacturing and clinical study expenses[13] - General and Administrative (G&A) expenses decreased to $7.9 million in Q3 2025 from $8.6 million in Q3 2024, attributed to reduced employee and consultant compensation[13] - Total operating expenses decreased to $21.2 million in Q3 2025 from $27.3 million in Q3 2024[13] - Total operating expenses for the three months ended September 30, 2025, were $21,210,455, down from $27,347,479 in 2024, representing a reduction of approximately 22%[27] - Research and development expenses for the nine months ended September 30, 2025, were $43,945,638, compared to $62,734,891 in 2024, indicating a decrease of about 30%[27] - General and administrative expenses for the nine months ended September 30, 2025, were $25,465,208, down from $29,395,232 in 2024, a decrease of about 13%[27] Cash and Assets - Cash, cash equivalents, and short-term investments were $50.8 million as of September 30, 2025, down from $94.1 million as of December 31, 2024[21] - INOVIO estimates an operational net cash burn of approximately $22 million for Q4 2025, with current cash expected to support operations into Q2 2026[17] - INOVIO's balance sheet shows total assets of $69.4 million and total liabilities of $77.1 million as of September 30, 2025[25] Other Financial Metrics - Interest income for the nine months ended September 30, 2025, was $1,970,823, down from $3,914,406 in 2024, a decrease of about 50%[27] - The change in fair value of common stock warrant liabilities for the nine months ended September 30, 2025, was a loss of $20,680,868, with no comparable figure for 2024[27] - The weighted average number of common shares used to compute net loss per share for the three months ended September 30, 2025, was 52,168,694, compared to 28,140,497 in 2024, indicating an increase of approximately 85%[27] - Net unrealized gain on available-for-sale equity securities for the nine months ended September 30, 2025, was $1,104,782, compared to $1,810,868 in 2024, a decrease of approximately 39%[27]

81% (26/32) of patients experienced a reduction of one or more surgeries at Year 1 post-treatment By the end of Year 2, 91% (21/23) of evaluable patients continued to experience a reduction of one or more surgeries. Only two patients had not yet responded to treatment with INO-3107 INO-3107 demonstrated continued clinical benefit, with a persistent decline in the mean number of surgeries through Year 2 post-therapy: A 78% reduction in mean annual surgeries was seen at Year 2 compared to the 1 year pre-treat ...