Core Insights - INOVIO's lead DNA medicine candidate, INO-3107, has received the U.K. Innovation Passport designation, which recognizes its potential to transform treatment for Recurrent Respiratory Papillomatosis (RRP) patients [1][7] - The Innovation Passport is part of the Innovative Licensing and Access Pathway (ILAP) aimed at accelerating market access and regulatory approval for promising medicines in the U.K. [2][7] - INO-3107 is designed to elicit a T cell response against HPV-6 and HPV-11, potentially reducing the need for surgical interventions in RRP patients [2][8] Company Overview - INOVIO is a biotechnology company focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases [12] - The company utilizes proprietary technology to design DNA plasmids and deliver them using its investigational device, CELLECTRA® [11][12] Product Details - INO-3107 has shown promising results in a Phase 1/2 clinical trial, with 81.3% of patients experiencing a decrease in surgical interventions after treatment [2][9] - The treatment generated a strong immune response, with activated CD4 and CD8 T cells observed, indicating a persistent cellular memory response [2][8] - INO-3107 was well tolerated, with mostly low-grade adverse effects reported [2][8] Regulatory Context - The ILAP, launched by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in 2021, aims to facilitate the development and access to innovative medicines [2][7] - Benefits of the ILAP include a potential 150-day accelerated assessment for Marketing Authorization Applications (MAA) and continuous benefit-risk assessments [2][7] Market Potential - RRP is a rare disease caused by HPV-6 and HPV-11, characterized by the growth of papillomas in the respiratory tract, which can lead to severe complications [10] - Market research indicates that even a reduction of one surgery is significant for patients, as each surgery carries risks of permanent damage [10]

This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and expectations regarding our research and development programs, including the planned submission of a BLA in the second half of 2024 and the planned commercial launch of INO-3107 if regulatory approval is obtained. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent ...

The stock option has an exercise price of $8.08, which is equal to the closing price of INOVIO's common stock on June 28, 2024. The stock option will vest and become exercisable with respect to one-fourth of the shares underlying the stock option on the Grant Date, and an additional one-fourth of the shares underlying the stock option on the first, second, and third anniversaries of the Grant Date. The vesting of the stock option will be subject to the employee's continued employment with INOVIO on the appl ...

For more information on the Russell 3000® Index and the Russell indexes reconstitution, visit the "Russell Reconstitution" section on the FTSE Russell website. FTSE Russell is a leading global provider of benchmarking, analytics, and data solutions for investors, giving them a precise view of the market relevant to their investment process. A comprehensive range of reliable and accurate indexes provides investors worldwide with the tools they require to measure and benchmark markets across asset classes, st ...

PLYMOUTH MEETING, Pa., June 4, 2024 /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 INOVIO's President and CEO, Dr. Jacqueline Shea, and Chief Medical Officer, Dr. Michael Sumner will participate in a virtual fireside chat hosted by Sudan Loganathan, Ph.D., Managing Director and equity research analyst at Stephens, Inc. The f ...

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease- fighting tools. For more information, visit www.inovio.com. Contacts Media: Jennie Willson, (267) 429-8567, [email protected] Investors: Thomas Hong, (267) 440-4298, [email protected] SOURCE INOV ...

Summary of Inovio Pharmaceuticals, Inc. Conference Call Company Overview - **Company**: Inovio Pharmaceuticals, Inc. (NASDAQ: INO) - **Industry**: Biotechnology, focusing on DNA medicines for HPV-related diseases, cancer, and infectious diseases [4][42] Key Points and Arguments INO-3107 Development - **Mechanism of Action**: INO-3107 aims to produce targeted antigen-specific T cells to destroy HPV-infected cells, preventing the recurrence of recurrent respiratory papillomatosis (RRP) [5][4] - **Patient Population**: Approximately 14,000 patients in the U.S. suffer from RRP, with peaks in incidence at ages 7, 30, and early 60s [6][4] - **Current Treatment Options**: The only current treatment is repeated surgery, highlighting the unmet medical need for alternatives [8][9] Clinical Data - **Phase 1/2 Study Results**: The study included 32 patients, showing an 81% response rate with reduced surgeries post-treatment; 28% of patients required no surgeries after the first dose [11][4] - **FDA Designation**: INO-3107 received breakthrough designation, allowing the use of Phase 1/2 data for the Biologics License Application (BLA) submission [13][4] Confirmatory Trial - **Trial Design**: The confirmatory trial will be placebo-controlled, maintaining the treatment regimen from the previous study [16][4] - **Regulatory Engagement**: The company is in discussions with the FDA and European regulators regarding the trial design and has begun site identification [14][17] Commercialization Plans - **Device Utilization**: The CELLECTRA 5PSP device is integrated for easy use, with a large safety database supporting its application [26][4] - **Market Strategy**: The company is analyzing healthcare provider and patient landscapes to effectively target its field force [27][4] - **Pricing and Market Adoption**: While pricing discussions are premature, there is a high unmet need, with surgery costs averaging $72,000 annually per patient [29][4] Pipeline and Future Candidates - **Upcoming Candidates**: Following INO-3107, the pipeline includes INO-3112 for HPV-related throat cancer, INO-4201 for Ebola, and INO-5401 for glioblastoma [37][38][40] - **Innovative Technologies**: The company is exploring DNA-launched nanoparticle vaccines and monoclonal antibody encoding, with promising early-stage candidates [39][4] Financial Outlook - **Cash Position**: The company has a cash runway extending to Q3 2025, with $105 million in cash and an additional $33.2 million raised recently [35][4] - **Sales Potential**: Anticipated sales from INO-3107 are expected to support the development of other pipeline candidates [32][4] Additional Important Information - **Patent Protection**: INO-3107 is protected by a broad patent portfolio, with key patents extending into the mid-2040s [31][4] - **Investor Message**: The company aims to transition to a commercial stage with the filing of its first BLA this year and a potential launch next year, alongside a robust pipeline [42][4]

Summary of Inovio Pharmaceuticals Conference Call Company Overview - Inovio Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing DNA medicines for HPV-related diseases, oncology, and infectious diseases [3][4] - The company is advancing its lead program, INO-3107, for the treatment of recurrent respiratory papillomatosis (RRP) [3][4] Key Developments - INO-3107 has received breakthrough therapy designation from the FDA, with plans to file a Biologics License Application (BLA) in the second half of 2024 and a potential launch in 2025 [4][18] - The company has a pipeline that includes INO-3112, aimed at treating HPV-related oropharyngeal squamous cell carcinoma, with plans to initiate a Phase 3 trial [4][40] Market Opportunity - RRP is caused by HPV 6 and 11, affecting approximately 14,000 prevalent cases in the U.S. and resulting in significant quality of life issues due to the need for repeated surgeries [8][7] - The average RRP patient undergoes about four surgeries per year, highlighting the unmet medical need for effective alternatives [13][8] Clinical Data - Inovio's Phase 1-2 trial for INO-3107 showed an 81% reduction in surgeries, with 28% of patients experiencing no surgeries post-treatment [11][30] - The median reduction in surgeries was three per year across the trial participants [13] Safety Profile - The safety profile of INO-3107 is favorable, with adverse events similar to placebo and no significant viral symptoms associated with administration [15][16] - The company has conducted nearly 18,000 plasmid administrations, providing a robust safety database [15] Regulatory Engagement - Inovio has engaged with the FDA throughout the regulatory process, ensuring alignment on the BLA submission and confirmatory study design [18][20] - The confirmatory trial will be a randomized placebo-controlled study, which is necessary for both U.S. and European regulatory approvals [20][36] Device and Administration - The administration device for INO-3107 is user-friendly and has received positive feedback from healthcare providers [31][32] - The device is designed for easy use in laryngologists' offices, enhancing the treatment experience for patients [31] Manufacturing Capabilities - Inovio has established commercial-scale manufacturing capabilities, ensuring sufficient supply for both clinical and commercial needs [34] Value Proposition - The primary value of INO-3107 lies in its potential to avoid surgeries and the associated risks of permanent vocal cord damage, as well as the emotional burden on patients [27][28] - Comparisons are drawn to other rare diseases, such as Desmoid tumors, to illustrate the potential impact of INO-3107 in the treatment landscape [28] Future Outlook - Inovio is focused on advancing its pipeline, particularly INO-3112, which targets high-risk HPV16 and 18 associated diseases with no current treatment options [40] - The company aims to conduct trials across North America and Europe, addressing a significant unmet need in the oncology space [40] Conclusion - Inovio Pharmaceuticals is positioned to make a significant impact in the treatment of RRP and HPV-related cancers, with promising clinical data and a strong regulatory strategy in place [38]

Financial Data and Key Metrics Changes - INOVIO reported a net loss of $30.5 million for Q1 2024, or $1.31 per share, compared to a net loss of $40.6 million, or $1.89 per share, for Q1 2023, indicating an improvement in financial performance [51] - Total operating expenses decreased from $44.1 million in Q1 2023 to $31.5 million in Q1 2024, a 29% reduction [44] - Cash, cash equivalents, and short-term investments increased to $105.6 million as of March 31, 2024, compared to $45.3 million at the end of 2023 [51] Business Line Data and Key Metrics Changes - R&D expenses for Q1 2024 totaled $20.9 million, down from $30.2 million in Q1 2023, reflecting reduced drug manufacturing and clinical trial costs [44][50] - G&A expenses decreased to $10.6 million in Q1 2024 from $13.9 million in Q1 2023, primarily due to lower employee compensation and legal expenses [45] Market Data and Key Metrics Changes - INOVIO is preparing for the potential approval and commercialization of INO-3107 for recurrent respiratory papillomatosis (RRP), with plans to file a Biologics License Application (BLA) in the second half of 2024 [9][10] - The company is also advancing INO-3112 for throat cancer and INO-4201 as an Ebola vaccine booster, indicating a diversified pipeline targeting significant unmet medical needs [11][32] Company Strategy and Development Direction - INOVIO's strategic focus includes the potential approval of INO-3107, advancing other promising candidates, and strengthening the overall business [8][9] - The company aims to establish key relationships and build a successful commercial launch strategy for INO-3107, which could be the first FDA-approved therapy for RRP [10][35] - INOVIO plans to conduct a placebo-controlled confirmatory trial for INO-3107, which aligns with feedback from both U.S. and European regulators [28][94] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the alignment with the FDA regarding the trial design for INO-3107 and the potential to initiate the trial soon [9][13] - The company remains committed to financial discipline and operational excellence, with a cash runway projected to extend into Q3 2025 [46] - Management acknowledged the impact of HPV vaccination rates on RRP incidence, noting that despite progress, a significant portion of the population remains unvaccinated [55][56] Other Important Information - INOVIO raised approximately $33 million through a common stock offering in April 2024, which will support commercialization efforts and pipeline progress [12][49] - The company is utilizing its proprietary CELLECTRA device for the delivery of DNA medicines, which has been well-received by both patients and healthcare providers [23][76] Q&A Session Summary Question: Impact of HPV vaccines on RRP rates - Management noted that while HPV vaccines have reduced pediatric RRP rates in countries with high vaccination rates, vaccination levels have stalled in many high-income countries, leaving a significant population unprotected [55][56] Question: Expected operational expenditure burn with Phase 3 trial for INO-3112 - Management indicated an increase in operational burn due to advancing commercial activities and the upcoming Phase 3 trial, with guidance suggesting cash runway into Q3 2025 [59] Question: Device aspects of the BLA for INO-3107 - Management confirmed that INO-3107 is regulated as a combination product, requiring submission for both the drug and device components, with significant experience from previous studies [62][64] Question: Enrollment timeline for the confirmatory trial - Management targeted approximately 100 patients for the confirmatory trial, expecting a similar recruitment period as the Phase 1/2 study, which was completed in less than a year [67][68] Question: Competitive landscape regarding administration routes - Management emphasized that the CELLECTRA device is well-tolerated and not seen as a barrier compared to subcutaneous administration, with positive feedback from physicians [76][77] Question: Sample size and powering assumptions for the confirmatory trial - Management confirmed a two-to-one randomization for the trial, aiming to limit the number of patients not receiving active treatment, with confidence in the effect size based on previous study data [91][92]

| --- | --- | --- | |-------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------| | | | | | as throat cancer | | | | Occurs in the base of the tongue, tonsils and/or soft palate | | | | Typically causally related to high-risk subtypes of HPV, some cases are carcinogen-driven | | | | HPV+ throat cancer rapidly increasing in incidence | | | | among patients in high-income countries ◦ Surpassed cervical ...