Financial Data and Key Metrics Changes - INOVIO reported a net income of $3.8 million for Q4 2025, translating to $0.06 per share, while the total net loss for the full year was $84.9 million or $1.81 per share [25][26] - Total operating expenses decreased from $20.5 million in Q4 2024 to $17.5 million in Q4 2025, and full-year operational expenses dropped 23% from $112.6 million in 2024 to $86.9 million in 2025 [25][26] - Cash equivalents and short-term investments at the end of Q4 2025 were $58.5 million, down from $94.1 million as of December 31, 2024 [25] Business Line Data and Key Metrics Changes - The primary focus remains on advancing INO-3107 towards FDA approval, with significant resources allocated to this lead candidate [5][24] - INOVIO is also advancing other promising candidates in its pipeline, including INO-5412 for glioblastoma, through partnerships [8][22] Market Data and Key Metrics Changes - The market for recurrent respiratory papillomatosis (RRP) treatment is characterized by a significant burden on patients, with surgery being the standard of care [15] - Market research indicates that INO-3107 has the potential to become the preferred treatment option based on its efficacy and tolerability [16][18] Company Strategy and Development Direction - INOVIO's strategy includes optimizing resources to extend cash runway towards the October 30, 2026 PDUFA date for INO-3107 [24][60] - The company is leveraging partnerships to advance its pipeline and is focused on innovative treatments for rare diseases with significant unmet needs [22][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in INO-3107's ability to meet an unmet medical need and provide a meaningful therapeutic benefit over existing treatments [5][11] - The company is preparing for a meeting with the FDA to discuss the Accelerated Approval Program and has submitted additional documentation to support its case [10][30] Other Important Information - INOVIO has reduced its workforce by approximately 15% to conserve financial resources [24] - The company is actively preparing for the commercial launch of INO-3107, including selecting key commercial partners and finalizing its go-to-market model [19][24] Q&A Session Summary Question: What additional data is needed for the FDA regarding Accelerated Approval? - Management indicated that no new clinical data is required, but they have submitted an Assessment Aid to reiterate their rationale for Accelerated Approval [29][30] Question: How would a six-month priority review timeline impact launch preparations? - Management stated that they are focused on ensuring alignment with the FDA for Accelerated Approval and are well advanced in commercial preparations [33][34] Question: How are third-party logistics and commercial partners being used to inform distribution strategy? - Management noted that they are learning from competitors and leveraging the experience of their partners to ensure a well-prepared launch [42][43] Question: Can you explain the rationale behind the Akeso partnership for GBM? - Management explained that combining PD-1 and CTLA-4 blockade is expected to enhance immune responses against tumor-associated antigens [48][49] Question: What are the plans for moving forward with 3112 if INO-3107 is approved? - Management indicated that resources are currently focused on INO-3107, but if approved, they will consider advancing 3112 based on available financial resources [55]

Financial Data and Key Metrics Changes - The company reported a net income of $3.8 million for Q4 2025, translating to $0.06 per share, while the full-year net loss was $84.9 million or $1.81 per share [25][26] - Total operating expenses decreased from $112.6 million in 2024 to $86.9 million in 2025, marking a 23% reduction [25] - Cash equivalents and short-term investments decreased from $94.1 million at the end of 2024 to $58.5 million at the end of Q4 2025 [25] Business Line Data and Key Metrics Changes - The primary focus remains on advancing INO-3107 towards FDA approval, with significant resources allocated to this lead candidate [5][24] - The company has also advanced its DNA medicine platform, including promising phase 1 proof of concept data for dMAb technology [21] Market Data and Key Metrics Changes - The market for recurrent respiratory papillomatosis (RRP) treatment is characterized by a significant burden on patients, with many requiring numerous surgeries throughout their lives [15] - Market research indicates that INO-3107 could become the preferred treatment option based on its efficacy and tolerability [16] Company Strategy and Development Direction - The company is focused on optimizing resources to extend its cash runway towards the October 30, 2026 PDUFA date for INO-3107 [24][60] - Strategic partnerships are being leveraged to advance other promising candidates in the pipeline, including collaborations in glioblastoma research [8][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in INO-3107's ability to meet an unmet medical need and provide a meaningful therapeutic benefit over existing treatments [7][11] - The company is preparing for a meeting with the FDA to discuss the BLA for INO-3107 and is awaiting feedback on an updated protocol for a confirmatory trial [10][30] Other Important Information - The company has reduced headcount by approximately 15% to conserve financial resources [24] - The FDA has accepted the BLA for INO-3107 under the Accelerated Approval Program, with a standard review timeline of 10 months [5][9] Q&A Session Summary Question: Additional data needed for FDA conversations regarding accelerated approval - Management confirmed that no new clinical data is required, but they have submitted new documentation to the FDA [30] Question: Impact of a potential priority review on launch preparations - The focus is currently on ensuring alignment with the FDA for accelerated approval, with commercial preparations well advanced [34][35] Question: Feedback from KOLs and patients on recent publications - Research indicates a strong preference for INO-3107 based on its efficacy and tolerability, with significant reductions in surgeries reported by patients [37][38] Question: Incorporating learnings from competitor's rollout into distribution strategy - The company is learning from competitor experiences and ensuring that their distribution strategy is well-prepared for launch [42][44] Question: Biological rationale of the dual PD-1/CTLA-4 blockade in partnership with Akeso - The combination aims to enhance immune responses against tumor-associated antigens, building on previous encouraging data [48][49] Question: Plans for INO-3112 if INO-3107 is approved - The company plans to focus resources on INO-3107 first, with potential to advance INO-3112 following approval and available financial resources [55]

Financial Data and Key Metrics Changes - Operating expenses decreased from $31.5 million in Q1 2024 to $25.1 million in Q1 2025, representing a 20% reduction [24] - Net loss for Q1 2025 was $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 [24] - Cash, cash equivalents, and short-term investments at the end of Q1 2025 were $68.4 million, down from $94.1 million at the end of 2024, with an estimated cash runway into Q1 2026 [24] Business Line Data and Key Metrics Changes - The primary focus remains on the submission of the Biologics License Application (BLA) for INO-3107, targeting recurrent respiratory papillomatosis (RRP) [5][6] - Significant progress was made in resolving manufacturing issues related to the Selectra device, with device design verification testing initiated [6][9] Market Data and Key Metrics Changes - RRP affects approximately 14,000 people in the US, with ongoing research suggesting this number may be an underestimate [15][30] - The current standard of care for RRP is surgery, which does not address the underlying disease, highlighting the urgent need for non-surgical treatment options [16] Company Strategy and Development Direction - The company aims to submit the BLA for INO-3107 by mid-2025, with a goal of receiving FDA acceptance by the end of the year [5][13] - The strategy includes leveraging market research insights to position INO-3107 as a preferred treatment option for patients and healthcare providers [7][18] - The company is also advancing its DNA encoded monoclonal antibody (dMAb) technology, which has shown promising interim results in clinical trials [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of INO-3107 to change the treatment paradigm for RRP, emphasizing the importance of each surgery to patients [73] - The company is focused on maintaining or improving clinical benefits seen to date and plans to submit a proposed protocol for a supplemental BLA in the future [14] Other Important Information - The company has been actively engaging with the RRP community and presenting data at scientific conferences to raise awareness of INO-3107 [10][11] - The dMAb technology is being explored for various disease targets, with initial proof of concept data showing durable antibody production [21][22] Q&A Session Summary Question: Details on the COSM presentation - The presentation will focus on surgery counts and additional data will be submitted for peer review [27][29] Question: Number of MSLs to onboard and epidemiology data - The company is conducting research to update the 14,000 active cases figure, which is believed to be an underestimate [30][31] Question: Expectation for surgery sparing claims and competitive differentiation - The FDA recognizes the clinical benefit of reduced surgeries, and the company believes it has a solid rationale for accelerated approval despite potential competition [36][46] Question: Plans for additional data in the filing package - The clinical package has been strengthened with detailed immunology characterization and durability data, and is ready for submission [48][49] Question: Pricing strategy and commercialization plans - Initial pricing is expected to be in line with other rare disease treatments, with plans to market INO-3107 in the US independently while considering partnerships for international markets [56][58] Question: Disclosure of baseline characteristics for the confirmatory trial - The patient population will be representative of the normal RRP population, with a focus on HPV serotypes [66][69]