Inovio Pharmaceuticals (INO) 2025 Conference Summary Company Overview - Inovio Pharmaceuticals is on track to potentially have the first DNA immunotherapy approved in the US, differentiating itself from mRNA therapies with unique stability and delivery systems [1][2] Key Differentiators of DNA Medicines - DNA medicines are more stable than mRNA and do not require lipid nanoparticles for delivery, allowing for easier distribution without ultra-cold storage [3][4] - DNA therapies generate robust T cell responses, particularly CD8 T cells, while mRNA is more effective at producing high levels of neutralizing antibodies [3][4] - The DNA platform avoids issues related to pre-existing anti-vector immunity and flu-like adverse events commonly associated with mRNA and viral vector therapies [3][4] Clinical Data and Safety Profile - Approximately 19,000 administrations have been conducted across 6,000 subjects, showing mild tolerability with no significant differentiation from placebo adverse events [8] - The manufacturing cost of DNA medicines varies based on scale, with a focus on reducing costs for vaccine indications [9][10] RRP (Recurrent Respiratory Papillomatosis) Indication - RRP is a rare disease caused by HPV types 6 and 11, leading to wart-like growths in the respiratory tract, significantly affecting patients' quality of life [13][14] - Current standard treatment involves repeated surgeries, which can lead to permanent vocal cord damage and high economic costs [14][15] - The estimated prevalence of RRP is likely higher than the previously reported 14,000 active patients, with HPV vaccination rates remaining stagnant [16][17] BLA Submission Timeline - Inovio plans to commence rolling submission for the Biologics License Application (BLA) by mid-2025, pending completion of device testing [18][19] - A manufacturing issue related to a disposable component was identified and resolved, allowing for progress towards BLA submission [20][21] Phase 1/2 Study Results - The Phase 1/2 study showed a statistically significant reduction in surgeries from a median of four to one, with 72% of patients experiencing a 50% or greater reduction in surgeries [25][28] - Long-term data indicates continued clinical improvement, with 86% of patients showing significant improvement over a median follow-up of 2.8 years [28][29] Confirmatory Trial Design - The FDA has requested a placebo-controlled confirmatory trial to validate efficacy, with plans to expand the clinical trial site base to over 20 sites [33][35] - The trial will include a representative patient population with varying disease severity and HPV types [34] dMAb Technology - Inovio's dMAb platform demonstrated the ability to produce monoclonal antibodies against COVID-19, showing sustained production without generating anti-drug antibodies [43][44] - The technology has potential applications in protein replacement therapies, expanding its therapeutic scope [44][45] Future Programs and Financial Position - Inovio is focusing resources on advancing INO-3107 for RRP while also discussing future developments for INO-312 for oropharyngeal cancer [45][46] - The company reported a cash position of $94.1 million, providing a runway into Q1 2026 [49]

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]

Core Points - INOVIO, a biotechnology company, focuses on developing and commercializing DNA medicines for HPV-associated diseases, cancers, and infectious diseases [1][3] - The company will release its first quarter 2025 financial results on May 13, 2025, after market close [1] - A live conference call and webcast will follow the financial results release at 4:30 p.m. ET, including a Q&A session with analysts [1][2] Company Overview - INOVIO's technology is designed to optimize the design and delivery of DNA medicines that enable the body to produce its own disease-fighting tools [3] - The company aims to protect and treat individuals from HPV-related diseases and other infectious diseases through its innovative approach [3]

Core Viewpoint - Inovio Pharmaceuticals (INO) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often adjust their valuations based on earnings estimates, leading to buying or selling actions that affect stock prices [4]. Recent Performance and Outlook - For the fiscal year ending December 2025, Inovio is expected to report earnings of -$2.27 per share, reflecting a 44% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Inovio has increased by 38.1%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - Inovio's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Viewpoint - Inovio Pharmaceuticals (INO) has experienced significant selling pressure, resulting in an 11.4% decline over the past four weeks, but analysts anticipate improved earnings in the near future [1] Group 1: Technical Analysis - The Relative Strength Index (RSI) is utilized to identify oversold stocks, with a reading below 30 indicating oversold conditions [2] - INO's current RSI reading is 25.47, suggesting that the heavy selling may be nearing exhaustion, potentially leading to a price rebound [5] Group 2: Fundamental Analysis - There is a strong consensus among sell-side analysts to raise earnings estimates for INO, with a 33.4% increase in the consensus EPS estimate over the last 30 days [7] - INO holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, indicating a favorable outlook for a potential turnaround [8]

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 [34] - 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 [33][34] - Cash, cash equivalents, and short-term investments at the end of Q4 2024 were $94.1 million, down from $145.3 million as of December 31, 2023, with an estimated cash runway into Q1 2026 [34] Business Line Data and Key Metrics Changes - The primary focus remains on advancing INO-3107, with plans to submit a Biologics License Application (BLA) in mid-2025 [6][20] - Significant progress was made in resolving manufacturing issues related to the Selexa device, which is crucial for the BLA submission [6][10] Market Data and Key Metrics Changes - RRP (Recurrent Respiratory Papillomatosis) affects approximately 14,000 people in the U.S., with repeated surgeries being the standard of care [21] - The market for INO-3107 is expected to be significant, as patients and providers are seeking non-surgical options to avoid the risks and costs associated with repeated surgeries [21][22] 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 the DNA Medicines platform [6][7] - The company is also exploring next-generation DNA medicines, including dMAb technology, which has shown promise in producing therapeutic antibodies durably within the human body [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficacy and tolerability of INO-3107, highlighting its potential to become the preferred treatment for RRP patients [22][24] - The company anticipates completing the rolling submission of the BLA by the end of 2025, contingent on successful device verification testing [20][52] Other Important Information - The company raised over $72 million in gross proceeds from equity offerings in 2024 to support its operations and BLA submission efforts [33] - The dMAb technology has shown durable antibody production for up to 72 weeks without generating anti-drug antibodies, indicating a potential breakthrough in therapeutic protein delivery [28][29] Q&A Session Summary Question: What is the status of the BLA submission for INO-3107? - Management confirmed that a pre-BLA meeting with the FDA had already taken place, and they plan to start the rolling submission once all modules are complete [37][38] Question: What is the timeline for testing and validation of the new manufacturing process? - The company expects to complete device verification testing in the first half of the year and will request rolling submission of the BLA thereafter [51][52] Question: Has any health economist or payer research been conducted regarding the pricing of INO-3107? - The company has conducted research with payers and anticipates a pricing range for rare diseases, which could be between $200,000 to $2,000,000 per year [66][67] Question: How durable is the in vivo antibody production from the dMAb technology? - The company reported that antibody production has been stable for up to 72 weeks, indicating excellent durability [73] Question: What are the expectations for the epidemiology and addressable market for RRP? - Management indicated that while pediatric cases are declining, adult cases remain steady, suggesting a sustained addressable market for RRP treatments [95][96]

Fourth Quarter & Full Year 2024 Financial Results • March 2025 Agenda Introduction Jennie Willson, Director, Communications CEO Perspective & Corporate Progress Jacqueline Shea, PhD, President & Chief Executive Officer INO-3107 Update Michael Sumner, MBBS, MBA, Chief Medical Officer Steve Egge, Chief Commercial Officer Financial Results Peter Kies, Chief Financial Officer 2 Forward-Looking Statements This presentation includes statements that are, or may be deemed, "forward-looking statements," within the m ...

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]

Financial Performance - Total revenues for the year ended December 31, 2024, were $218,000, a decrease from $832,000 in 2023[11] - Total revenue for the year ended December 31, 2024, was $217,756, a decrease of 73.8% compared to $832,010 in 2023[25] - INOVIO's net loss for the year ended December 31, 2024, was $107.3 million, or $3.95 per share, compared to a net loss of $135.1 million, or $6.09 per share, in 2023[19] - Net loss for 2024 was $107,254,126, compared to a net loss of $135,117,352 in 2023, indicating an improvement of 20.7%[25] - The company reported a basic and diluted net loss per share of $3.95 in 2024, an improvement from $6.09 in 2023[25] Expenses - Research and Development (R&D) expenses for the year ended December 31, 2024, were $75.6 million, down from $86.7 million in 2023[11] - Research and development expenses were $75,620,340 in 2024, down from $86,676,563 in 2023, a decrease of 12.8%[25] - General and Administrative (G&A) expenses for the year ended December 31, 2024, were $37.0 million, compared to $47.6 million in 2023[11] - General and administrative expenses decreased to $36,996,338 in 2024 from $47,582,104 in 2023, a reduction of 22.2%[25] - Total operating expenses decreased to $112,616,678 in 2024 from $144,772,038 in 2023, representing a reduction of 22.2%[25] Cash and Assets - Cash, cash equivalents, and short-term investments as of December 31, 2024, were $94.1 million, down from $145.3 million as of December 31, 2023[11] - Cash and cash equivalents increased to $65,813,297 in 2024 from $14,310,862 in 2023, showing a significant increase of 359.5%[23] - Total assets decreased to $113,197,206 in 2024 from $170,951,423 in 2023, a decline of 33.8%[23] - Total liabilities decreased to $44,693,411 in 2024 from $53,602,294 in 2023, a reduction of 16.5%[23] Clinical Development - INOVIO anticipates starting the rolling submission of its first Biologics License Application (BLA) for INO-3107 in mid-2025, aiming for complete submission acceptance by the end of 2025[3] - In a retrospective study, 50% of patients treated with INO-3107 achieved a Complete Response in the second 12-month period, with 86% showing a reduction in surgery of 50% or greater[5] - INOVIO plans to advance development for a Phase 3 trial for INO-3112 in combination with LOQTORZI, having gained alignment with the FDA on the trial design[11] Manufacturing and Operational Insights - The company has made significant progress in resolving manufacturing issues related to the CELLECTRA device, enabling the final step of FDA-required device verification testing[8] - INOVIO estimates an operational net cash burn of approximately $27 million for the first quarter of 2025[14] - The weighted average number of common shares outstanding increased to 27,160,863 in 2024 from 22,173,662 in 2023[25]

Core Insights - INOVIO is progressing towards submitting its first Biologics License Application (BLA) for INO-3107, targeting recurrent respiratory papillomatosis (RRP), with plans to start the submission process in mid-2025 and aim for priority review by the end of the year [2][4][9] Operational Highlights - The company resolved a manufacturing issue related to the CELLECTRA device, allowing for the completion of non-device BLA modules [4][5] - A retrospective study indicated that 50% of RRP patients treated with INO-3107 achieved a complete response in the second year, with 86% showing a significant reduction in surgery needs [4][5] - Interim results from a Phase 1 trial of DNA-encoded monoclonal antibodies (DMAb) targeting COVID-19 demonstrated well-tolerated and durable in vivo antibody production [4][5] Financial Results - As of December 31, 2024, INOVIO reported total revenues of $218,000, a decrease from $832,000 in 2023 [15] - Research and Development (R&D) expenses for 2024 were $75.6 million, down from $86.7 million in 2023, attributed to lower employee compensation and clinical trial expenses [15] - The net loss for the year was $107.3 million, or $3.95 per share, compared to a net loss of $135.1 million, or $6.09 per share, in 2023 [15][19] Cash Position - INOVIO's cash, cash equivalents, and short-term investments totaled $94.1 million as of December 31, 2024, down from $145.3 million in 2023 [15] - The company anticipates a net cash burn of approximately $27 million for the first quarter of 2025, projecting sufficient cash to support operations into the first quarter of 2026 [12]