Core Viewpoint - INOVIO is on track to complete the Biologics License Application (BLA) for INO-3107 by the end of 2025, with the FDA agreeing to its rolling submission timeline for the treatment of Recurrent Respiratory Papillomatosis (RRP) [1][2] Group 1: Company Overview - INOVIO is a biotechnology company focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases [7] - The company utilizes a proprietary DNA medicines platform that includes DNA plasmids and the CELLECTRA delivery device, which optimally delivers DNA medicines without the need for chemical adjuvants [6] Group 2: Product Information - INO-3107 is an investigational DNA medicine targeting HPV-6 and HPV-11, designed to elicit a T cell response to combat these infections [4] - In a Phase 1/2 trial, 72% of patients experienced a 50-to-100% reduction in surgeries after one year of treatment with INO-3107, increasing to 86% after two years [4] Group 3: Regulatory Designations - INO-3107 has received Orphan Drug and Breakthrough Therapy designations from the FDA, allowing for accelerated approval based on Phase 1/2 trial data [5] - The European Commission has also granted Orphan Drug designation to INO-3107, and the UK has awarded it the Innovation Passport [5] Group 4: Market Context - RRP is a rare disease primarily caused by HPV-6 and HPV-11, characterized by wart-like growths in the respiratory tract, which can lead to severe complications [3] - The estimated prevalence of RRP in the U.S. is about 14,000 active cases, with approximately 1.8 new cases per 100,000 adults each year [3]

Core Insights - INOVIO announced its financial results for Q2 2025 and provided updates on its product development, particularly focusing on INO-3107 for Recurrent Respiratory Papillomatosis (RRP) [1][9] Financial Performance - R&D expenses decreased to $14.5 million in Q2 2025 from $23.1 million in Q2 2024, primarily due to lower drug manufacturing and clinical study expenses [16] - G&A expenses also decreased to $8.6 million in Q2 2025 from $10.2 million in Q2 2024, attributed to reduced stock-based compensation and lower outside services [16] - Total operating expenses fell to $23.1 million in Q2 2025 from $33.3 million in Q2 2024 [16] - Net loss for Q2 2025 was $23.5 million, or $0.61 per share, down from a net loss of $32.2 million, or $1.19 per share, in Q2 2024 [16][19] Product Development Updates - INOVIO completed device DV testing for CELLECTRA 5PSP and requested FDA rolling submission for BLA of INO-3107, aiming for acceptance by year-end 2025 [2][3] - INOVIO is preparing for a confirmatory trial with 100 patients across 20 sites in the U.S. [3] - A retrospective study showed significant clinical benefits of INO-3107, with surgery reduction rates improving from 72% in Year 1 to 86% in Year 2 [4][6] Upcoming Events and Presentations - INOVIO plans to present data on INO-3107 and other DNA medicine candidates at several upcoming conferences, including the American Academy of Otolaryngology and the World Vaccine Congress Europe [7] Cash Position and Guidance - As of June 30, 2025, INOVIO had cash, cash equivalents, and short-term investments totaling $47.5 million, down from $94.1 million at the end of 2024 [16] - The company estimates its cash resources will support operations into Q2 2026, with a projected net cash burn of approximately $22 million for Q3 2025 [11]

Core Insights - INOVIO announced positive long-term clinical data for INO-3107, showing a significant reduction in surgeries for patients with recurrent respiratory papillomatosis (RRP) [1][2] - The retrospective study published in The Laryngoscope indicates that the majority of patients maintained or improved their surgical response two years post-treatment [2][5] Summary by Sections Clinical Data and Efficacy - A retrospective study involving 28 of the original 32 patients from a Phase 1/2 trial showed an Overall Response Rate (ORR) improvement to 86% at the end of Year 2, up from 72% at Year 1 [5][6] - The Complete Response (CR) rate increased from 28% in Year 1 to 50% in Year 2, indicating that half of the patients required no surgeries at all [5][6] - The mean number of surgeries needed dropped from 4.1 per year prior to treatment to 1.7 in Year 1 and further to 0.9 in Year 2 [5][6] Safety and Tolerability - INO-3107 was well tolerated, with no serious adverse events or long-term safety concerns reported [6][8] - Most treatment-emergent adverse effects were low-grade, such as injection site pain and fatigue [8] Market Potential and Regulatory Designations - INOVIO believes that the sustained reduction in surgeries could position INO-3107 as a preferred treatment option for RRP if approved [2][9] - The FDA has granted INO-3107 Orphan Drug and Breakthrough Therapy designations, allowing for accelerated approval processes [9] - INOVIO has also received CE-marking for its CELLECTRA delivery device in the EU, facilitating commercialization [9] Background on RRP and INO-3107 - RRP is a rare disease primarily caused by HPV-6 and HPV-11, leading to benign growths in the respiratory tract that can cause severe complications [4][8] - 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 [8][11]

Core Insights - INOVIO is on track to submit its Biologics License Application (BLA) for INO-3107, a treatment for recurrent respiratory papillomatosis (RRP), in mid-2025, with the goal of FDA acceptance by the end of 2025 [2][3][7] - The company reported a decrease in net loss for Q1 2025 to $19.7 million, or $0.51 per share, compared to a net loss of $30.5 million, or $1.31 per share, in Q1 2024 [15][19] - INOVIO's cash, cash equivalents, and short-term investments were $68.4 million as of March 31, 2025, down from $94.1 million at the end of 2024, with an estimated operational net cash burn of approximately $22 million for Q2 2025 [12][15] Company Developments - INOVIO has initiated device design verification testing for the CELLECTRA device, which is required for the BLA submission, expected to be completed in the first half of 2025 [3][7] - The company is conducting ongoing market research to support its commercial readiness plans and has published clinical data from a Phase 1/2 trial in a peer-reviewed journal [4][6] - Promising interim results from a Phase 1 proof-of-concept trial for DNA-encoded monoclonal antibodies (DMAbs) were announced, with additional data to be presented at upcoming scientific meetings [6][9] Financial Performance - Research and development expenses decreased to $16.1 million in Q1 2025 from $20.9 million in Q1 2024, primarily due to lower drug manufacturing and immunology expenses [15] - General and administrative expenses also decreased to $9.0 million in Q1 2025 from $10.6 million in Q1 2024, attributed to lower legal expenses and stock-based compensation [15] - Total operating expenses for Q1 2025 were $25.1 million, down from $31.5 million in the same period of 2024 [15][19]

Core Insights - INOVIO is focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases, and will present at several upcoming conferences to share new data on its lead candidate INO-3107 [1][4] Conference Presentations - INOVIO will participate in the Citizens JMP Life Sciences Conference on May 8, featuring a fireside chat format [2] - At the European Laryngological Society Annual Congress on May 9, INOVIO will present data showing that INO-3107 generates a targeted immunologic response, resulting in surgery reduction for 81% of adults with recurrent respiratory papillomatosis in the first year [2] - The American Society of Gene and Cell Therapy will host a poster abstract session on May 13, discussing the successful treatment of recurrent respiratory papillomatosis with INO-3107, regardless of papilloma microenvironment and molecular subtype [2] - An oral presentation at the ABEA program during the COSM on May 15 will focus on the durability and long-term clinical effects of INO-3107 in treating recurrent respiratory papillomatosis caused by HPV types 6 and 11 [3] Company Overview - INOVIO is a biotechnology company that specializes in the design and delivery of innovative DNA medicines, aiming to empower the body to produce its own disease-fighting tools [4]

Financial Data and Key Metrics Changes - Inovio's net loss for Q4 2024 was $19.4 million or $0.65 per share, with a total net loss for the full year of 2024 amounting to $107.3 million or $3.95 per share [55] - Total operating expenses decreased from $27.5 million in Q4 2023 to $20.5 million in Q4 2024, and full-year operational expenses dropped 22% from $144.8 million in 2023 to $112.6 million in 2024 [54][55] - The company finished Q4 2024 with $94.1 million in cash, cash equivalents, and short-term investments, down from $145.3 million as of December 31, 2023, estimating a cash runway into Q1 2026 [55] Business Line Data and Key Metrics Changes - The primary focus is on advancing INO-3107, with plans to submit a Biologics License Application (BLA) under the FDA's rolling submission process in mid-2025 [9][31] - INO-3107 showed a complete response rate of 50% in the second year, with the mean number of surgeries per year reducing from 4.1 to 0.9 surgeries [23][24] - The ongoing efficacy of INO-3107 is supported by immunology data demonstrating an anti-viral immune response that correlates with reduced surgery needs [12][30] Market Data and Key Metrics Changes - Recurrent respiratory papillomatosis (RRP) affects around 14,000 people in the U.S., with repeated surgeries being the standard of care [34] - The market for RRP treatment is characterized by a need for non-surgical options, as surgeries pose risks and costs to patients [35] - The company anticipates that INO-3107 could become the preferred treatment option based on its efficacy and tolerability [36] Company Strategy and Development Direction - The company aims to transform into a commercial-stage entity by focusing on three strategic priorities: submitting the BLA for INO-3107, advancing the commercial plan, and leveraging its DNA medicines platform [9][10] - The company is also exploring next-generation DNA medicines, including DMAbs technology for long-term in-vivo production of therapeutic antibodies [13][42] - Plans for a Phase 3 trial for INO-3112 in combination with a PD-1 inhibitor for HPV-related throat cancer are underway [51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of INO-3107 as a non-surgical treatment for RRP, emphasizing the importance of reducing the need for surgeries [11][26] - The company is optimistic about the durability of the immune response generated by INO-3107 and the potential for redosing strategies to enhance treatment outcomes [136] - Management highlighted the ongoing challenges in the adult RRP population, indicating that the disease is likely to persist for generations despite vaccination efforts [140] Other Important Information - The company raised over $72 million in gross proceeds from equity offerings in 2024 to support its operations [54] - The DMAb technology has shown promising results in producing antibodies durably and simultaneously in humans, with no serious adverse events reported [44][46] - The company is preparing for commercial launch by developing distribution strategies and pricing models for INO-3107 [39][40] Q&A Session Summary Question: BLA submission process for INO-3107 - Management confirmed that a pre-BLA meeting with the FDA was held, and no further meeting is required before the rolling submission [62][64] Question: Stability testing for the CELLECTRA device - The company needs to repeat several tests for device verification, which will be conducted by an external testing house [67][68] Question: Durability of DMAb technology - The company reported that DMAb production has shown durability for up to 72 weeks without significant drop in antibody levels [113] Question: Health economics research on INO-3107 - The company has conducted research with payers, indicating a potential pricing range for INO-3107 similar to other rare disease therapies [105][106] Question: Redosing strategy for INO-3107 - Management is still deciding on the redosing strategy, aiming to maintain and potentially enhance the immune response [134][136] Question: Epidemiology and addressable market for RRP - The company noted that RRP cases in adults remain steady despite vaccination efforts, indicating a significant addressable market [140]