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 ...

Exhibit 99.1 • The proposed confirmatory trial will be randomized and placebo-controlled, involving approximately 100 patients with a history of ≥2 surgeries per year, with a treatment option for the placebo arm at trial end. This trial design is intended to target a broader spectrum of RRP disease than other candidates currently in development. If INO-3107 receives full approval from the FDA, INOVIO believes the design of the confirmatory trial could also support expansion into global markets based on feed ...

PLYMOUTH MEETING, Pa., May 13, 2024 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced its financial results for the first quarter of 2024 and provided an update on recent company developments. "In the first quarter of 2024, we continued to deliver on our priorities for the year. Of utmost importance, we remain on track to submit our B ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NO. 001-14888 INOVIO PHARMACEUTICALS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) Delaware 33-0969592 (State or other jurisdiction of ...

PLYMOUTH MEETING, Pa., April 29, 2024 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that management will participate in the following investor conferences during the month of May: The Citizens JMP Life Sciences ConferenceDate: Tuesday, May 14, 2024Time: 11:30 AM ETPresenter: Dr. Jacqueline Shea, President & CEOFormat: Fireside Ch ...

PLYMOUTH MEETING, Pa., April 15, 2024 /PRNewswire/ -- INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced the pricing of an underwritten offering of 2,536,258 shares of its common stock at an offering price of $7.693 per share and pre-funded warrants to purchase 2,135,477 shares of its common stock at an offering price of $7.692 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NO. 001-14888 INOVIO PHARMACEUTICALS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) (State or other jurisdiction of incorporation or organiza ...