Core Insights - INOVIO is advancing its lead product candidate INO-3107 for the treatment of Recurrent Respiratory Papillomatosis (RRP) and has initiated the rolling submission of its Biologics License Application (BLA), expected to be completed in the second half of 2025 with a goal for FDA acceptance by the end of 2025 [1][5]. Group 1: INO-3107 Presentations - INOVIO will present data on INO-3107 at several upcoming scientific conferences, including the American Academy of Otolaryngology Annual Meeting, World Vaccine Congress Europe, and the European Society for Medical Oncology Congress, showcasing its long-term efficacy and immune response in treating HPV-6/11 RRP [3][4][5]. - Specific presentations include topics such as "DNA Immunotherapy (INO-3107) Demonstrates a Durable Response for Treatment of HPV-6/11 Recurrent Respiratory Papillomatosis" and "Clinical Response to INO-3107 in RRP is Irrespective of Papilloma Microenvironment and Molecular Subtype" [3][4]. Group 2: Next-Generation DNA Medicine - INOVIO is also focusing on its next-generation DNA medicine technology, with presentations planned on a Phase 1 clinical trial of a DNA-encoded monoclonal antibody (DMAb) and new preclinical data on DNA-encoded protein technology (DPROT) for Hemophilia A [2][5]. - Upcoming presentations will cover the CELLECTRA® in vivo gene delivery platform and the transformational potential of DMAb technology in rare diseases [4][5]. Group 3: Company Overview - INOVIO is a biotechnology company dedicated to developing and commercializing DNA medicines aimed at treating HPV-related diseases, cancer, and infectious diseases, utilizing innovative technology to enhance the design and delivery of these medicines [6].

Company Overview - Inovio is a clinical stage biotech company focused on developing and commercializing DNA medicines for HPV-related diseases, cancer, and infectious diseases [2][3] - The company has a deep pipeline of therapeutic and vaccine candidates with multiple potential near and midterm catalysts [3] Lead Program - The lead program is INO-3107, aimed at treating recurrent respiratory papillomatosis (RRP), a rare HPV-related disease [4] - INO-3107 has received breakthrough therapy and orphan drug designations from the FDA and is following the accelerated approval pathway [4] Regulatory Milestones - Inovio expects to complete its Biologics License Application (BLA) submission in the second half of the year, with the goal of FDA acceptance by year-end [5] - The company believes INO-3107 has the potential to become the preferred first-line treatment over the current standard of care, which includes repeated surgery and a recently FDA-approved therapy [5]

Summary of Inovio Pharmaceuticals (INO) FY Conference Call - September 05, 2025 Company Overview - Inovio Pharmaceuticals is a clinical-stage biotech company focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases [2][3] - The company has a deep pipeline of therapeutic and vaccine candidates with multiple potential near and mid-term catalysts [2] Lead Program: INO-3107 - INO-3107 is aimed at treating recurrent respiratory papillomatosis (RRP), a rare HPV-related disease [3] - The FDA has granted breakthrough therapy and orphan drug designations for INO-3107, and the company is following an accelerated approval pathway [3] - The Biologics License Application (BLA) submission is expected in the second half of the year, with a goal for FDA acceptance by year-end [5][18] - INO-3107 is positioned to become the first DNA medicine approved in the U.S. [5] Clinical Trials and Efficacy - The Phase 1/2 trial (001) enrolled 32 patients who had required at least two surgical interventions in the prior year [11] - Results showed a statistically significant reduction in surgeries from a median of 4 prior to treatment to 1 at the end of 12 months [12] - In the follow-up trial (002), 28 of the original 32 patients were enrolled, showing continued improvement with a median follow-up of 2.8 years [12] - By the end of the second year, the mean number of surgeries reduced from 1.7 to 0.9, representing over 75% reduction compared to the year prior to treatment [15] Commercial Opportunity - There are an estimated 14,000 patients in the U.S. with RRP, with about 1.8 per 100,000 new cases annually [19] - INO-3107 is expected to be a preferred product due to its efficacy, tolerability, and patient-centric treatment approach [20] - The treatment can be administered in a doctor's office, making it convenient for both patients and healthcare providers [22] Pipeline and Future Developments - Inovio has additional clinical-stage candidates following INO-3107, including DMAP candidates that encode monoclonal antibodies [24][25] - The DMAP technology showed durable production of monoclonal antibodies with no serious adverse events reported [25][26] - The company is in discussions for potential collaborations to further develop its technologies [26] Key Takeaways - INO-3107 represents a significant advancement in treating RRP, addressing both the symptoms and underlying viral infection [19][20] - The company is on track for its BLA submission and is preparing for a commercial launch [18][22] - Inovio's innovative DNA medicine technology has the potential to transform treatment paradigms for various diseases [17][26]

Core Insights - Inovio Pharmaceuticals' shares increased by 20.6% following FDA's acceptance of a rolling submission timeline for the biologics license application (BLA) for INO-3107, aimed at treating recurrent respiratory papillomatosis (RRP) in adults [1][5] - The company plans to finalize the BLA submission in the coming months and seeks priority review, targeting FDA acceptance by the end of 2025 [1][2] - INO-3107 is designed to elicit a targeted T cell response against HPV-6 and HPV-11, which cause RRP, and has received breakthrough therapy and orphan drug designations in the U.S. [3][5] Company Developments - Inovio's BLA submission is supported by data from a completed phase I/II study that demonstrated the candidate's safety, tolerability, immunogenicity, and efficacy in patients with HPV-related RRP [6] - The FDA has indicated that the completed study could support a BLA filing under the accelerated approval program, negating the need for a pivotal phase III study [6] - A confirmatory study for INO-3107 will be initiated, enrolling 100 patients across the U.S. [7] Industry Context - Precigen, Inc. recently received FDA approval for Papzimeos, a treatment for RRP, which also holds breakthrough therapy and orphan drug designations [8] - Precigen's Papzimeos was approved based on data from a pivotal phase I/II study, which met primary safety and efficacy endpoints, eliminating the need for a confirmatory study [10] - Year-to-date, Inovio's shares have risen by 34.4%, significantly outperforming the industry average growth of 3.2% [4]

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 is a biotechnology company focused on developing and commercializing DNA medicines for HPV-associated diseases, cancer, and infectious diseases [3] Group 1: Conference Details - INOVIO announced a pre-recorded presentation will be available on demand as part of the H.C. Wainwright 27th Annual Global Investment Conference in New York [1] - The presentation will be accessible starting September 5, 2025, at 7:00 AM ET and will remain available for 90 days [2] - INOVIO's management team will also conduct in-person one-on-one meetings with investors during the conference [1] Group 2: Company Overview - INOVIO's technology focuses on optimizing the design and delivery of innovative DNA medicines that enable the body to produce its own disease-fighting tools [3] - The company aims to help treat and protect individuals from HPV-related diseases, cancer, and infectious diseases [3]

Financial Data and Key Metrics Changes - Operating expenses decreased from $33.3 million in 2024 to $23.1 million in 2025, a 31% reduction [21] - Net loss for 2025 dropped 27% to $23.5 million from $32.2 million in 2024, with a per share loss of $0.61 compared to $1.19 in 2024 [22] - Cash and short-term investments at the end of 2025 were $47.5 million, down from $94.1 million at the end of 2024 [23] Business Line Data and Key Metrics Changes - The company is focused on the BLA submission for INO-3107, with significant progress made in regulatory preparations [5][9] - The completion of design verification testing for the Selectra 5 PSP device allows for the next regulatory milestones [5][9] Market Data and Key Metrics Changes - The U.S. market for RRP is estimated to have around 14,000 active cases, with the prevalence likely underestimated due to plateauing HPV vaccination rates [16] - The company believes that the HPV vaccine will not significantly impact RRP prevalence in adults for at least a generation [16] Company Strategy and Development Direction - The company aims to submit the BLA for INO-3107 in the second half of 2025 and is preparing for a potential launch [5][6] - There is a focus on advancing the broader pipeline, including dMAb and Dprop technologies, with ongoing partnerships to enhance development [8][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of INO-3107 to become a new standard of care for RRP, addressing significant unmet needs [12][13] - The company is committed to maintaining a strong cash runway into 2026, with an operational net cash burn estimate of approximately $22 million for 2025 [23][24] Other Important Information - The BLA for INO-3107 would be the first filed for DNA medicine in the U.S., potentially opening doors for future partnerships [25] - The company is actively preparing for commercial launch, including distribution strategies and pricing discussions with payers [20][74] Q&A Session Summary Question: Anticipation of an advisory committee meeting for the filing - Management indicated that there has been no indication from the FDA that an advisory committee meeting will be required [30] Question: Impact of competitor's regulatory decision on the company's launch - Management noted significant differences between their program and the competitor's, suggesting that the competitor's outcome may not directly impact their launch [32] Question: Clarification on the completion of DV testing - Management confirmed that they remain on track for BLA submission in the second half of 2025, despite the complexity of the DV testing process [40] Question: Redosing strategy based on new data - Management plans to implement a redosing strategy, likely annual, to maintain clinical benefits for patients [44] Question: Enrollment challenges for the confirmatory trial due to competitor's potential approval - Management expressed confidence in recruiting the necessary patients, citing the prevalence of the disease and potential insurance coverage issues [52] Question: Commercial infrastructure needed for launch - Management indicated that a small, cost-efficient commercial organization will be sufficient to target the 300 to 400 laryngologists treating RRP patients [58] Question: Timelines for major upcoming events - Management outlined expectations for FDA feedback on the rolling submission in August and aims for BLA acceptance by year-end [67]

[Executive Summary](index=1&type=section&id=Executive%20Summary) INOVIO announced Q2 2025 results, with the CEO confirming the INO-3107 BLA submission is on track for 2H25, targeting mid-2026 FDA approval [Introduction and CEO Statement](index=1&type=section&id=Introduction%20and%20CEO%20Statement) INOVIO announced its second quarter 2025 financial results and provided business updates, with the CEO highlighting that the Biologics License Application (BLA) for INO-3107 is on track for submission in the second half of 2025, aiming for FDA acceptance by year-end and potential approval by mid-2026 - INO-3107 BLA submission remains on track for **2H25**, with the goal of FDA acceptance by year-end[3](index=3&type=chunk) - Potential INO-3107 approval date is anticipated in **mid-2026**[3](index=3&type=chunk) [Operational Highlights](index=1&type=section&id=Operational%20Highlights) INOVIO advanced INO-3107 with BLA progress and strong clinical data, while also presenting next-gen DNA medicine data and strengthening its financial position [INO-3107 (Recurrent Respiratory Papillomatosis - RRP)](index=1&type=section&id=INO-3107%20(Recurrent%20Respiratory%20Papillomatosis%20-%20RRP)) INOVIO made significant progress with INO-3107, completing device verification testing and initiating a rolling BLA submission, with long-term clinical data demonstrating sustained efficacy and safety, showing a substantial reduction in surgeries for RRP patients [Regulatory and Commercial Progress](index=1&type=section&id=Regulatory%20and%20Commercial%20Progress) INOVIO completed device verification for CELLECTRA® 5PSP, requested a rolling BLA submission for INO-3107, and advanced commercial preparations - Completed design verification (DV) testing for the CELLECTRA® 5PSP device, a requirement for BLA submission[4](index=4&type=chunk)[5](index=5&type=chunk) - Requested rolling submission from the US FDA for INO-3107 in **July 2025**, leveraging its Breakthrough Therapy designation[4](index=4&type=chunk)[5](index=5&type=chunk) - Continuing to advance commercial preparations for the potential launch of INO-3107 in **2026**, if approved by the FDA[5](index=5&type=chunk) [Clinical Data and Efficacy](index=2&type=section&id=Clinical%20Data%20and%20Efficacy) Long-term clinical data for INO-3107, published in The Laryngoscope, demonstrated sustained efficacy with significant reductions in RRP surgeries and a favorable safety profile - Data from a retrospective study (RRP-002) investigating the long-term clinical efficacy of INO-3107 were published in The Laryngoscope[5](index=5&type=chunk)[6](index=6&type=chunk) - Patients experiencing a **50-100% reduction in surgeries** (Overall Response Rate) increased from **72% at Year 1 to 86% at Year 2**[9](index=9&type=chunk) - Patients achieving a Complete Response (**0 surgeries per year**) increased from **28% for Year 1 to 50% for Year 2**[9](index=9&type=chunk) - Mean number of surgeries reduced from **4.1 (pre-treatment) to 1.7 (Year 1) and further to 0.9 (Year 2)**[9](index=9&type=chunk) - INO-3107 was well tolerated, with no serious adverse events or long-term safety concerns identified[9](index=9&type=chunk) [Next Generation DNA Medicine Candidates](index=2&type=section&id=Next%20Generation%20DNA%20Medicine%20Candidates) INOVIO presented data on its next-generation DNA medicine technology, including DNA-encoded monoclonal antibodies (DMAbs) for COVID-19 and DNA-encoded protein technology (DPROT) for long-term protein expression, at the Orphan Drug Summit - Presented data on next-generation DNA medicine technology at the Orphan Drug Summit in **July**[6](index=6&type=chunk) - Data included key insights from an ongoing Phase 1 proof-of-concept trial evaluating DNA-encoded monoclonal antibodies (DMAbs) for COVID-19[6](index=6&type=chunk) - Provided an overview of DNA-encoded protein technology (DPROT) that targets long-term protein expression[6](index=6&type=chunk) [General Corporate Developments](index=2&type=section&id=General%20Corporate%20Developments) INOVIO maintained its focus on financial discipline, directing resources towards the INO-3107 program, and strengthened its balance sheet through a public offering in July 2025, which generated approximately $22.5 million in net proceeds - Remains focused on financial discipline and directing resources to support the INO-3107 program[7](index=7&type=chunk) - Strengthened its balance sheet with an underwritten public offering of common stock and warrants in **July 2025**[7](index=7&type=chunk) - Net proceeds from the July 2025 offering were approximately **$22.5 million**[7](index=7&type=chunk) [Upcoming Presentations](index=2&type=section&id=Upcoming%20Presentations) INOVIO is scheduled to present data on INO-3107 and other promising DNA medicine candidates at several key industry conferences throughout October 2025 - INOVIO will present data on INO-3107 and other DNA medicine candidates at multiple upcoming events in **October 2025**, including the American Academy of Otolaryngology and World Vaccine Congress Europe[7](index=7&type=chunk)[10](index=10&type=chunk) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Performance) INOVIO reported significantly reduced operating expenses and net loss for Q2 2025, with cash and investments supporting operations into Q2 2026 [Summary of Financial Results](index=2&type=section&id=Summary%20of%20Financial%20Results) For the second quarter of 2025, INOVIO reported a significant decrease in total operating expenses and a reduced net loss compared to the same period in 2024, driven by lower R&D and G&A expenditures Total Operating Expenses (Three Months Ended June 30) | Year | Amount (USD) | | :--- | :--- | | 2025 | $23.1 million | | 2024 | $33.3 million | | **Change (YoY)** | **↓ 30.6%** | Net Loss (Three Months Ended June 30) | Year | Amount (USD) | | :--- | :--- | | 2025 | $(23.5) million | | 2024 | $(32.2) million | | **Change (YoY)** | **↓ 27.0%** | Net Loss Per Share (Basic and Diluted, Three Months Ended June 30) | Year | Amount (USD) | | :--- | :--- | | 2025 | $(0.61) | | 2024 | $(1.19) | | **Change (YoY)** | **↓ 48.7%** | [Research and Development (R&D) Expenses](index=2&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) R&D expenses for Q2 2025 decreased substantially compared to Q2 2024, primarily due to reduced costs associated with drug manufacturing, clinical studies for INO-3107, and lower contract labor R&D Expenses (Three Months Ended June 30) | Year | Amount (USD) | | :--- | :--- | | 2025 | $14.5 million | | 2024 | $23.1 million | | **Change (YoY)** | **↓ 37.2%** | - The decrease was primarily a result of lower drug manufacturing, clinical study, and other expenses related to INO-3107, and lower contract labor[11](index=11&type=chunk) [General and Administrative (G&A) Expenses](index=2&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) G&A expenses for Q2 2025 also saw a decrease year-over-year, mainly attributed to lower employee and consultant stock-based compensation, reduced outside services, and decreased contract labor G&A Expenses (Three Months Ended June 30) | Year | Amount (USD) | | :--- | :--- | | 2025 | $8.6 million | | 2024 | $10.2 million | | **Change (YoY)** | **↓ 15.7%** | - The decrease was primarily related to a decrease in employee and consultant stock-based compensation, lower outside services, and lower contract labor[11](index=11&type=chunk) [Cash, Cash Equivalents and Investments](index=3&type=section&id=Cash%2C%20Cash%20Equivalents%20and%20Investments) As of June 30, 2025, INOVIO's cash, cash equivalents, and short-term investments totaled $47.5 million, a decrease from $94.1 million at the end of 2024, excluding the net proceeds from the July 2025 public offering Cash, Cash Equivalents and Short-term Investments | Date | Amount (USD) | | :--- | :--- | | June 30, 2025 | $47.5 million | | December 31, 2024 | $94.1 million | | **Change** | **↓ 49.5%** | - This balance excludes net proceeds of approximately **$22.5 million** from the July 2025 public offering[7](index=7&type=chunk)[17](index=17&type=chunk) [Cash Guidance and Runway](index=3&type=section&id=Cash%20Guidance%20and%20Runway) INOVIO estimates that its current cash, cash equivalents, and short-term investments, including the July 2025 offering proceeds, will support operations into the second quarter of 2026, with an anticipated operational net cash burn of approximately $22 million for Q3 2025 - Current cash, cash equivalents, and short-term investments (including July 2025 offering proceeds) are estimated to support operations into the **second quarter of 2026**[13](index=13&type=chunk) - Operational net cash burn estimate for the third quarter of 2025 is approximately **$22 million**[13](index=13&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements present INOVIO's balance sheet and statements of operations, detailing assets, liabilities, equity, and financial performance for Q2 2025 and year-to-date [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets provide a detailed snapshot of INOVIO's financial position, showing total assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024, reflecting a decrease in total assets and liabilities over the period Consolidated Balance Sheet Highlights | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Total current assets | $52,697,149 | $97,830,050 | ↓ 46.2% | | Total assets | $68,240,504 | $113,197,206 | ↓ 39.7% | | Total current liabilities | $31,707,610 | $35,325,584 | ↓ 10.2% | | Total liabilities | $39,709,599 | $44,693,411 | ↓ 11.1% | | Total Stockholders' Equity | $28,530,905 | $68,503,795 | ↓ 58.4% | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) The consolidated statements of operations detail INOVIO's financial performance for the three and six months ended June 30, 2025, and 2024, illustrating reduced operating expenses and a lower net loss across both periods compared to the prior year Consolidated Statements of Operations Highlights (Three Months Ended June 30) | Metric | 2025 (USD) | 2024 (USD) | Change (YoY) | | :--- | :--- | :--- | :--- | | Revenue from collaborative arrangement | $— | $100,762 | ↓ 100% | | Research and development | $14,521,407 | $23,090,989 | ↓ 37.1% | | General and administrative | $8,563,112 | $10,206,686 | ↓ 16.1% | | Total operating expenses | $23,084,519 | $33,297,675 | ↓ 30.6% | | Loss from operations | $(23,084,519) | $(33,196,913) | ↓ 30.5% | | Net loss | $(23,519,412) | $(32,237,098) | ↓ 27.0% | | Net loss per share (Basic and diluted) | $(0.61) | $(1.19) | ↓ 48.7% | Consolidated Statements of Operations Highlights (Six Months Ended June 30) | Metric | 2025 (USD) | 2024 (USD) | Change (YoY) | | :--- | :--- | :--- | :--- | | Revenue from collaborative arrangement | $65,343 | $100,762 | ↓ 35.2% | | Research and development | $30,612,309 | $44,001,307 | ↓ 30.4% | | General and administrative | $17,588,082 | $20,781,337 | ↓ 15.4% | | Total operating expenses | $48,200,391 | $64,782,644 | ↓ 25.6% | | Loss from operations | $(48,135,048) | $(64,681,882) | ↓ 25.6% | | Net loss | $(43,214,109) | $(62,706,969) | ↓ 31.1% | | Net loss per share (Basic and diluted) | $(1.12) | $(2.48) | ↓ 54.9% | [Company Information](index=3&type=section&id=Company%20Information) This section provides an overview of INOVIO's proprietary DNA medicines platform and its mission to develop treatments for HPV-related diseases, cancer, and infectious diseases [About INOVIO's DNA Medicines Platform](index=3&type=section&id=About%20INOVIO%27s%20DNA%20Medicines%20Platform) INOVIO's DNA medicines platform utilizes precisely designed DNA plasmids, delivered by its proprietary CELLECTRA investigational medical device, to enable the body's cells to produce specific disease-fighting proteins without the need for chemical adjuvants or viral vectors - INOVIO's DNA medicines platform comprises precisely designed DNA plasmids and its proprietary investigational medical device, CELLECTRA[15](index=15&type=chunk) - DNA plasmids function like software, allowing the body's cells to produce specific proteins to target and fight disease[15](index=15&type=chunk) - CELLECTRA delivery devices are designed to optimally deliver DNA medicines without chemical adjuvants, lipid nanoparticles, or the risk of anti-vector response[15](index=15&type=chunk) [About INOVIO](index=3&type=section&id=About%20INOVIO) INOVIO is a biotechnology company dedicated to developing and commercializing DNA medicines for HPV-related diseases, cancer, and infectious diseases, by leveraging technology that empowers the body to generate its own disease-fighting mechanisms - INOVIO is a biotechnology company focused on developing and commercializing DNA medicines[16](index=16&type=chunk) - Its DNA medicines aim to treat and protect people from HPV-related diseases, cancer, and infectious diseases[16](index=16&type=chunk) - The technology optimizes the design and delivery of DNA medicines to teach the body to manufacture its own disease-fighting tools[16](index=16&type=chunk) [Important Disclosures](index=4&type=section&id=Important%20Disclosures) This section includes important forward-looking statements regarding INOVIO's business and provides contact information for media and investor inquiries [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding INOVIO's business, including clinical trials, regulatory submissions, commercialization, and financial projections, which are subject to inherent risks and uncertainties that could cause actual results to differ materially from expectations - The press release contains forward-looking statements related to business plans, clinical trials, BLA submission, commercial launch, and cash resource sufficiency[18](index=18&type=chunk) - Actual events or results may differ from expectations due to uncertainties inherent in preclinical studies, clinical trials, product development, funding availability, and regulatory approvals[18](index=18&type=chunk) [Contacts](index=4&type=section&id=Contacts) Contact information is provided for media and investor relations inquiries - Media Contact: Jennie Willson, (267) 429-8567, communications@inovio.com[19](index=19&type=chunk) - Investors Contact: Peter Vozzo - ICR Healthcare, (443) 213-0505, investor.relations@inovio.com[19](index=19&type=chunk)

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]

Part I. Financial Information [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Presents Inovio Pharmaceuticals' unaudited condensed consolidated financial statements for Q2 2025 and FY 2024, detailing financial position, performance, equity, and cash flows, with explanatory notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=a%29%20Condensed%20Consolidated%20Balance%20Sheets) Details the company's financial position as of June 30, 2025, and December 31, 2024, showing decreased total assets and equity from reduced cash, investments, and accumulated deficit | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $24,351,377 | $65,813,297 | | Short-term investments | $23,198,083 | $28,300,232 | | Total current assets | $52,697,149 | $97,830,050 | | Total assets | $68,240,504 | $113,197,206 | | Total current liabilities | $31,707,610 | $35,325,584 | | Total liabilities | $39,709,599 | $44,693,411 | | Total stockholders' equity | $28,530,905 | $68,503,795 | | Accumulated deficit | $(1,773,433,371)| $(1,730,219,262) | [Condensed Consolidated Statements of Operations](index=6&type=section&id=b%29%20Condensed%20Consolidated%20Statements%20of%20Operations) Shows financial performance for Q2 2025 and 2024, indicating continued net losses, decreased revenue from collaborative arrangements, and reduced operating expenses, especially in R&D | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------------- | :------------------------------- | :------------------------------- | | Revenue from collaborative arrangement | $0 | $100,762 | | Research and development | $14,521,407 | $23,090,989 | | General and administrative | $8,563,112 | $10,206,686 | | Total operating expenses | $23,084,519 | $33,297,675 | | Loss from operations | $(23,084,519) | $(33,196,913) | | Net loss | $(23,519,412) | $(32,237,098) | | Basic and diluted net loss per share | $(0.61) | $(1.19) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------------- | :----------------------------- | :----------------------------- | | Revenue from collaborative arrangement | $65,343 | $100,762 | | Research and development | $30,612,309 | $44,001,307 | | General and administrative | $17,588,082 | $20,781,337 | | Total operating expenses | $48,200,391 | $64,782,644 | | Loss from operations | $(48,135,048) | $(64,681,882) | | Net loss | $(43,214,109) | $(62,706,969) | | Basic and diluted net loss per share | $(1.12) | $(2.48) | [Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=c%29%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Details net loss and other comprehensive loss components for Q2 2025 and 2024, showing total comprehensive loss for each period | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :---------------------- | :------------------------------- | :------------------------------- | | Net loss | $(23,519,412) | $(32,237,098) | | Other comprehensive loss| $(422) | $(13,322) | | Comprehensive loss | $(23,519,834) | $(32,250,420) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------- | :----------------------------- | :----------------------------- | | Net loss | $(43,214,109) | $(62,706,969) | | Other comprehensive loss| $13,925 | $(59,338) | | Comprehensive loss | $(43,200,184) | $(62,733,904) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=d%29%20Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Illustrates changes in equity components for Q2 2025 and 2024, reflecting net losses, common stock issuances, RSU vesting, and stock-based compensation | Metric | Balance at Dec 31, 2024 | Balance at Jun 30, 2025 | | :-------------------------------------- | :---------------------- | :---------------------- | | Common stock (shares) | 36,099,991 | 36,718,527 | | Common stock (amount) | $36,099 | $36,719 | | Additional paid-in capital | $1,799,362,625 | $1,802,589,299 | | Accumulated deficit | $(1,730,219,262) | $(1,773,433,371) | | Total stockholders' equity | $68,503,795 | $28,530,905 | - Issuance of common stock for cash, net of financing costs, contributed **$1,102,149** to additional paid-in capital during the six months ended June 30, 2025[18](index=18&type=chunk) - Stock-based compensation added **$1,399,349** and **$834,792** to additional paid-in capital for the periods ending March 31, 2025, and June 30, 2025, respectively[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=e%29%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes cash movements from operating, investing, and financing activities for H1 2025 and 2024, showing a significant decrease in cash and cash equivalents in 2025 | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(47,685,386) | $(56,969,306) | | Net cash provided by investing activities | $5,230,313 | $55,348,949 | | Net cash provided by financing activities | $993,153 | $21,669,496 | | (Decrease) Increase in cash and cash equivalents | $(41,461,920) | $20,081,542 | | Cash and cash equivalents, end of period | $24,351,377 | $34,392,404 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=f%29%20Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures supporting the condensed consolidated financial statements, covering business, accounting policies, liquidity, fair value, equity, related parties, commitments, contingencies, and subsequent events [1. Organization and Operations](index=11&type=section&id=1.%20Organization%20and%20Operations) Inovio Pharmaceuticals is a clinical-stage biotechnology company developing DNA medicines for HPV, cancer, and infectious diseases using proprietary CELLECTRA devices, with INO-3107 for RRP as its lead candidate - Inovio is a clinical-stage biotechnology company developing DNA medicines for HPV, cancer, and infectious diseases, leveraging its proprietary CELLECTRA devices[25](index=25&type=chunk)[26](index=26&type=chunk) - The lead candidate, INO-3107 for RRP, showed **81.3% of patients** experienced a reduction in surgical interventions in a Phase 1/2 trial[27](index=27&type=chunk) - The company is also developing DNA medicines for HPV-related OPSCC and anal dysplasia, glioblastoma multiforme (GBM), and an Ebola vaccine booster[28](index=28&type=chunk) [2. Basis of Presentation, Liquidity and Risks and Uncertainties](index=11&type=section&id=2.%20Basis%20of%20Presentation%2C%20Liquidity%20and%20Risks%20and%20Uncertainties) Outlines financial statement basis, highlights liquidity challenges from net losses and accumulated deficit, and raises substantial doubt about going concern beyond Q2 2026 without additional capital - The company incurred net losses of **$23.5 million** and **$43.2 million** for the three and six months ended June 30, 2025, respectively[34](index=34&type=chunk) - As of June 30, 2025, the company had working capital of **$21.0 million** and an accumulated deficit of **$1.8 billion**[34](index=34&type=chunk) - Cash, cash equivalents, and short-term investments of **$47.5 million** as of June 30, 2025, combined with **$22.5 million** net proceeds from the July 2025 Offering, are expected to fund operations into Q2 2026[38](index=38&type=chunk)[35](index=35&type=chunk) - Management believes there is substantial doubt about the company's ability to continue as a going concern beyond Q2 2026 without additional capital[40](index=40&type=chunk) [Liquidity](index=12&type=section&id=Liquidity) Liquidity is constrained by net losses and accumulated deficit; recent public offerings provided capital, but further financing is required to sustain future operations - Net proceeds from the July 2025 Offering were **$22.5 million**[35](index=35&type=chunk) - Net proceeds from the December 2024 Offering were **$27.6 million**[36](index=36&type=chunk) - Net proceeds from the April 2024 Offering were **$33.2 million**[37](index=37&type=chunk) [Going Concern](index=12&type=section&id=Going%20Concern) Ability to continue operations depends on securing additional capital, as current resources are projected to last only into Q2 2026, raising substantial doubt about going concern beyond this period - Current financial resources are expected to support planned operations into the second quarter of 2026[38](index=38&type=chunk) - Additional capital is needed for future R&D activities, potentially through strategic alliances, licensing, grants, or debt/equity financings[39](index=39&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern beyond Q2 2026[40](index=40&type=chunk) [3. Critical Accounting Policies](index=13&type=section&id=3.%20Critical%20Accounting%20Policies) Details critical accounting policies, focusing on revenue recognition from collaboration agreements and the estimation and accrual of research and development expenses for clinical trials [Collaboration Agreements and Revenue Recognition](index=13&type=section&id=Collaboration%20Agreements%20and%20Revenue%20Recognition) Assesses collaboration agreements under ASC Topic 808 and 606, recognizing payments as R&D expense reduction if the partner is not a customer, or as revenue if a customer - Collaboration agreements are assessed under ASC Topic 808 and Topic 606[43](index=43&type=chunk) - Payments from collaboration partners are presented as a reduction of R&D expense if the partner is not a customer, or as revenue if the partner is a customer[43](index=43&type=chunk) [Research and Development Expenses - Clinical Trial Accruals](index=13&type=section&id=Research%20and%20Development%20Expenses%20-%20Clinical%20Trial%20Accruals) Clinical trial expenses are accrued based on estimates of total costs, participant enrollment, and study completion, subject to revisions expensed when known, though historically not material - Clinical trial expenses are accrued based on estimates of total costs, participant enrollment, and study completion[44](index=44&type=chunk) - Accrued clinical trial costs are subject to revisions, which are charged to expense in the period the facts become known[44](index=44&type=chunk) [4. Short-term Investments and Fair Value Measurements](index=13&type=section&id=4.%20Short-term%20Investments%20and%20Fair%20Value%20Measurements) Summarizes available-for-sale securities and fair value measurements, categorizing assets and liabilities into Level 1, 2, and 3, and details changes in common stock warrant liability fair value | Investment Type | Fair Market Value (June 30, 2025) | Fair Market Value (Dec 31, 2024) | | :------------------------------ | :-------------------------------- | :------------------------------- | | Mutual funds | $14,438,567 | $24,480,709 | | U.S. treasury securities | $4,957,550 | N/A | | Certificates of deposit | $2,989,454 | $2,989,742 | | U.S. agency mortgage backed securities | $812,512 | $829,781 | | Total short-term investments | $23,198,083 | $28,300,232 | - The company recorded net unrealized gains on available-for-sale equity securities of **$759,000** and **$900,000** for the three and six months ended June 30, 2025, respectively[46](index=46&type=chunk) | Liability | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Common stock warrant liability | $11,420,326 | $13,255,188 | - The fair value of the common stock warrant liability decreased by **$1,834,862** for the six months ended June 30, 2025[56](index=56&type=chunk) [5. Certain Balance Sheet Items](index=16&type=section&id=5.%20Certain%20Balance%20Sheet%20Items) Provides a breakdown of specific balance sheet items, including prepaid and other current assets, and accounts payable and accrued expenses, showing changes between June 30, 2025, and December 31, 2024 | Account | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Prepaid clinical expenses | $1,180,456 | $627,962 | | Other prepaid expenses | $3,126,921 | $1,889,503 | | Total prepaid and other current assets | $4,307,377 | $2,517,465 | | Account | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Trade accounts payable | $5,114,144 | $5,091,503 | | Accrued compensation | $8,655,207 | $10,007,180 | | Other accrued expenses | $1,981,340 | $1,101,330 | | Total accounts payable and accrued expenses | $15,750,691 | $16,200,013 | [6. Convertible Debt](index=16&type=section&id=6.%20Convertible%20Debt) Details the company's 6.50% convertible senior notes due 2024, fully repaid in March 2024, resulting in no interest expense for H1 2025 - The **$78.5 million** aggregate principal amount of 6.50% convertible senior notes due 2024 were fully repaid on March 1, 2024[58](index=58&type=chunk)[59](index=59&type=chunk) - No interest expense was recognized for the six months ended June 30, 2025, compared to **$178,000** for the same period in 2024[59](index=59&type=chunk) [7. Stockholders' Equity](index=16&type=section&id=7.%20Stockholders%27%20Equity) Outlines authorized and issued common and preferred stock, details recent equity offerings, At-The-Market sales agreements, and information on stock options and RSUs under incentive plans | Stock Type | Authorized Shares | Issued Shares (June 30, 2025) | Issued Shares (Dec 31, 2024) | | :------------------------------ | :---------------- | :---------------------------- | :--------------------------- | | Common Stock, $0.001 par value | 600,000,000 | 36,718,527 | 36,099,991 | | Series C Preferred Stock, $0.001 par value | 1,091 | 9 | 9 | - The December 2024 Offering involved **10,000,000 shares** of common stock and warrants, with net proceeds of **$27.6 million**[61](index=61&type=chunk)[36](index=36&type=chunk) - The April 2024 Offering included **2,536,258 shares** of common stock and **2,135,477 pre-funded warrants**, generating net proceeds of **$33.2 million**[63](index=63&type=chunk)[37](index=37&type=chunk) - Under the 2024 Sales Agreement, **518,670 shares** of common stock were sold for **$1.1 million** net proceeds during the six months ended June 30, 2025[67](index=67&type=chunk) - The 2023 Omnibus Incentive Plan was amended to increase shares available for issuance by **2,200,000**[69](index=69&type=chunk) [8. Net Loss Per Share](index=18&type=section&id=8.%20Net%20Loss%20Per%20Share) Details the calculation of basic and diluted net loss per share, which were identical due to the anti-dilutive effect of common stock warrants, stock options, and RSUs | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------------- | :------------------------------- | :------------------------------- | | Net loss | $(23,519,412) | $(32,237,098) | | Weighted-average common shares outstanding | 38,830,053 | 27,197,802 | | Net loss per share (Basic and diluted) | $(0.61) | $(1.19) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(43,214,109) | $(62,706,969) | | Weighted-average common shares outstanding | 38,722,451 | 25,244,657 | | Net loss per share (Basic and diluted) | $(1.12) | $(2.48) | - Potential common stock shares (warrants, options, RSUs, convertible preferred stock) totaling **12,873,206** for 2025 and **1,783,353** for 2024 were excluded from diluted EPS calculation due to their anti-dilutive effect[78](index=78&type=chunk) [9. Stock-Based Compensation](index=19&type=section&id=9.%20Stock-Based%20Compensation) Details stock-based compensation expenses for employees, directors, and non-employees, including valuation assumptions for stock options and RSUs, and information on performance- and market-based RSU awards | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | | Total employee and director stock-based compensation | $819,000 | $1,500,000 | | R&D expenses (included) | $319,000 | $581,000 | | G&A expenses (included) | $500,000 | $890,000 | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Total employee and director stock-based compensation | $2,200,000 | $3,900,000 | | R&D expenses (included) | $866,000 | $1,600,000 | | G&A expenses (included) | $1,300,000 | $2,300,000 | - Unrecognized compensation expense for unvested stock options was **$2.0 million**, expected to be recognized over **1.7 years**[82](index=82&type=chunk) - Unrecognized compensation expense for unvested service-based RSUs was **$2.2 million**, expected to be recognized over **2.0 years**[84](index=84&type=chunk) - No stock-based compensation expense was recognized for Milestone-based RSUs for the six months ended June 30, 2025, as achievement was not probable[93](index=93&type=chunk) [10. Related Party Transactions](index=21&type=section&id=10.%20Related%20Party%20Transactions) Details transactions and relationships with related parties, including an investment in Plumbline Life Sciences (PLS) and collaborative research agreements with The Wistar Institute, where a director holds positions - The company holds a **15.7% ownership interest** in Plumbline Life Sciences, Inc. (PLS), valued at **$3.1 million** as of June 30, 2025[97](index=97&type=chunk) - Collaborative research agreements with The Wistar Institute involve reimbursement for research costs and exclusive rights to in-license new intellectual property[99](index=99&type=chunk) | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------------------------- | :------------------------------- | :----------------------------- | | Contra-research and development expense from Wistar | $315,000 | $601,000 | | Research and development expenses from Wistar | $72,000 | $72,000 | [11. Commitments and Contingencies](index=22&type=section&id=11.%20Commitments%20and%20Contingencies) Outlines lease commitments for office, laboratory, and manufacturing space, and provides updates on ongoing legal proceedings, including VGXI and GeneOne litigations, with GeneOne settled post-period | Operating Lease Liabilities Maturity | Amount | | :----------------------------------- | :----- | | Remainder of 2025 | $1,766,000 | | 2026 | $3,592,000 | | 2027 | $2,992,000 | | 2028 | $2,319,000 | | 2029 | $2,132,000 | | Total remaining lease payments | $12,801,000 | - The company is involved in litigation with VGXI, Inc. regarding alleged breach of a supply agreement and counterclaims[112](index=112&type=chunk)[113](index=113&type=chunk) - The GeneOne litigation, concerning a breached CELLECTRA Device License Agreement, was settled on August 1, 2025, via a Settlement Agreement and Mutual Release[115](index=115&type=chunk)[116](index=116&type=chunk) [12. Collaborative Agreements](index=23&type=section&id=12.%20Collaborative%20Agreements) Details key collaborative agreements, including with ApolloBio Corporation for VGX-3100, and the discontinuation of development efforts with CEPI and the Bill & Melinda Gates Foundation for certain vaccine candidates - ApolloBio Corporation has exclusive rights to develop and commercialize VGX-3100 in agreed territories, with potential milestone payments up to **$20.0 million** and tiered royalties[119](index=119&type=chunk)[120](index=120&type=chunk) | Revenue Source | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :---------------------- | :------------------------------- | :----------------------------- | :------------------------------- | :----------------------------- | | ApolloBio Agreement | $0 | $65,000 | $101,000 | $101,000 | - Development of Lassa fever and MERS vaccine candidates with CEPI was discontinued in 2022[122](index=122&type=chunk) - The grant from the Bill & Melinda Gates Foundation for DMAbs development was closed out in Q1 2024[124](index=124&type=chunk) [13. Income Taxes](index=24&type=section&id=13.%20Income%20Taxes) Explains income tax accounting, noting no provision or benefit due to net operating losses and a full valuation allowance, and mentions evaluation of the One Big Beautiful Bill Act (OBBBA) impact - No income tax provision or benefit was recorded for the six months ended June 30, 2025, and 2024, due to net operating losses and a full valuation allowance[126](index=126&type=chunk) - The company is evaluating the impact of the One Big Beautiful Bill Act (OBBBA), signed July 4, 2025, on its financial condition, but does not anticipate a material change to its effective income tax rate due to the full valuation allowance[127](index=127&type=chunk) [14. Geneos Therapeutics, Inc.](index=24&type=section&id=14.%20Geneos%20Therapeutics%2C%20Inc.) Describes the company's equity method investment in Geneos Therapeutics, formed for personalized cancer therapies; due to Geneos's net losses, Inovio's investment is reduced to $0 with no future funding obligation - The company holds **23%** of Geneos Therapeutics' outstanding equity on an as-converted basis[130](index=130&type=chunk) - The investment in Geneos has been reduced to **$0** as of June 30, 2025, and December 31, 2024, due to Geneos's continuing net losses[130](index=130&type=chunk) - Inovio exclusively licenses its immunotherapy platform and CELLECTRA technology to Geneos for neoantigen-based cancer therapy, with potential royalty payments[131](index=131&type=chunk) [15. Segment Information](index=25&type=section&id=15.%20Segment%20Information) Operates as a single reportable segment focused on developing and commercializing DNA medicines; the CEO uses aggregated financial information, primarily total net loss, to assess performance and allocate resources - The company operates as one reportable segment in the United States[132](index=132&type=chunk) - The CEO is the Chief Operating Decision Maker, using total net loss and detailed expense information to allocate resources[133](index=133&type=chunk) | R&D Program (Six Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | | :------------------------------------- | :------------------ | :------------------ | | INO-3107 | $7,437 | $18,689 | | INO-3112 and other Immuno-oncology | $2,752 | $3,583 | | Other programs | $260 | $827 | | Engineering and device-related | $10,146 | $8,589 | | Stock-based compensation | $875 | $1,650 | | Other unallocated expenses | $9,139 | $10,661 | | Total R&D expenses | $30,612 | $44,001 | [16. Subsequent Events](index=26&type=section&id=16.%20Subsequent%20Events) Discloses significant events after the reporting period, including the July 2025 Offering closing, full exercise of April 2024 Pre-Funded Warrants, and GeneOne litigation settlement - On July 7, 2025, the company closed an underwritten public offering, raising **$22.5 million** in net proceeds from the issuance of common stock and accompanying warrants[136](index=136&type=chunk)[137](index=137&type=chunk) - In July 2025, **2,135,477 Pre-Funded Warrants** from the April 2024 Offering were fully exercised, yielding **$2,000** in proceeds[137](index=137&type=chunk) - On August 1, 2025, the company and GeneOne entered into a Settlement Agreement and Mutual Release to resolve all claims between them[138](index=138&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on financial condition and results of operations, including business overview, critical accounting policies, revenue/expense analysis, and liquidity/capital resources, emphasizing ongoing funding needs [Overview](index=27&type=section&id=Overview) Inovio is a clinical-stage biotech developing DNA medicines and CELLECTRA devices; lead candidate INO-3107 for RRP is on track for BLA submission in H2 2025, with other candidates in development, but no commercialized products and expected continued operating losses - Inovio is a clinical-stage biotechnology company focused on DNA medicines for HPV-associated diseases, cancer, and infectious diseases, delivered by proprietary CELLECTRA devices[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) - The lead candidate, INO-3107 for RRP, is expected to have its BLA submitted in the second half of 2025, with a goal of FDA file acceptance by year-end, following resolution of a manufacturing issue with the CELLECTRA 5PSP device[149](index=149&type=chunk) - The company has an accumulated deficit of **$1.8 billion** as of June 30, 2025, and expects to incur substantial operating losses in the future[155](index=155&type=chunk) [Critical Accounting Policies and Estimates](index=28&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) No significant changes to critical accounting estimates since December 31, 2024; key estimates include collaboration agreements, revenue recognition, and clinical trial accruals - No significant changes to critical accounting estimates since December 31, 2024[157](index=157&type=chunk) - Critical accounting estimates include collaboration agreements and revenue recognition, and research and development expenses (clinical trial accruals)[43](index=43&type=chunk)[44](index=44&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Analyzes financial performance for Q2 2025 and 2024, detailing changes in revenue, operating expenses (R&D, G&A), and other income/expense, reflecting decreased losses but also reduced revenue and increased engineering costs [Revenue](index=29&type=section&id=Revenue) Total revenue decreased significantly for Q2 2025 and H1 2025 compared to 2024, primarily from the ApolloBio collaborative arrangement | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | Revenue from collaborative arrangement | $0 | $101,000 | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Revenue from collaborative arrangement | $65,000 | $101,000 | [Research and development expenses](index=29&type=section&id=Research%20and%20development%20expenses) R&D expenses decreased by 37% and 30% for Q2 2025 and H1 2025, respectively, primarily due to lower drug manufacturing, clinical study, and contract labor costs for INO-3107 and INO-5401, partially offset by increased engineering and device-related expenses | R&D Category (Three Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | Change ($) | Change (%) | | :---------------------------------------- | :------------------ | :------------------ | :--------- | :--------- | | INO-3107 | $3,930 | $11,043 | $(7,113) | (64)% | | INO-3112 and other Immuno-oncology | $1,438 | $1,563 | $(125) | (8)% | | Other research and development programs | $153 | $204 | $(51) | (25)% | | Engineering and device-related | $5,085 | $4,839 | $246 | 5% | | Stock-based compensation | $322 | $590 | $(268) | (45)% | | Other unallocated expenses | $3,593 | $4,852 | $(1,259) | (26)% | | Total R&D expense | $14,521 | $23,091 | $(8,570) | (37)% | | R&D Category (Six Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | Change ($) | Change (%) | | :-------------------------------------- | :------------------ | :------------------ | :--------- | :--------- | | INO-3107 | $7,437 | $18,689 | $(11,252) | (60)% | | INO-3112 and other Immuno-oncology | $2,754 | $3,584 | $(830) | (23)% | | Other research and development programs | $260 | $827 | $(567) | (69)% | | Engineering and device-related | $10,147 | $8,590 | $1,557 | 18% |\ | Stock-based compensation | $875 | $1,650 | $(775) | (47)% | | Other unallocated expenses | $9,139 | $10,661 | $(1,522) | (14)% | | Total R&D expense | $30,612 | $44,001 | $(13,389) | (30)% | - Contributions from grant agreements recorded as contra-R&D expense increased to **$315,000** and **$601,000** for the three and six months ended June 30, 2025, respectively, from **$9,000** and **$188,000** in 2024[162](index=162&type=chunk) [General and administrative expenses](index=30&type=section&id=General%20and%20administrative%20expenses) G&A expenses decreased for Q2 2025 and H1 2025 compared to 2024, primarily due to lower employee severance, stock-based compensation, outside services, contract labor, and legal expenses | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | General and administrative expenses | $8.6 million | $10.2 million | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | General and administrative expenses | $17.6 million | $20.8 million | - Lower employee severance expenses: **$525,000** (3 months), **$505,000** (6 months)[172](index=172&type=chunk) - Lower employee and consultant stock-based compensation: **$411,000** (3 months), **$1.0 million** (6 months)[172](index=172&type=chunk) - Lower outside services: **$377,000** (3 months), **$588,000** (6 months)[172](index=172&type=chunk) - Lower legal expenses: **$31,000** (3 months), **$776,000** (6 months)[172](index=172&type=chunk) [Stock-based compensation](index=30&type=section&id=Stock-based%20compensation) Total employee and director stock-based compensation expense decreased for Q2 2025 and H1 2025 compared to 2024, primarily due to a lower weighted average grant date fair value for awards granted in 2025 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | | Total employee and director stock-based compensation | $819,000 | $1.5 million | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Total employee and director stock-based compensation | $2.2 million | $3.9 million | - The decrease in stock-based compensation was due to a lower weighted average grant date fair value for awards granted during 2025[163](index=163&type=chunk) [Interest income](index=30&type=section&id=Interest%20income) Interest income decreased for Q2 2025 and H1 2025 compared to 2024, primarily due to a lower short-term investment balance | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------- | :------------------------------- | :------------------------------- | | Interest income | $611,000 | $1.3 million | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | Interest income | $1.4 million | $2.8 million | - The decrease in interest income was primarily due to a lower short-term investment balance[164](index=164&type=chunk) [Interest expense](index=30&type=section&id=Interest%20expense) Interest expense was $0 for Q2 2025 and H1 2025, a decrease from the prior year due to the full repayment of senior convertible notes in March 2024 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------- | :------------------------------- | :------------------------------- | | Interest expense| $0 | $0 | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | Interest expense| $0 | $178,000 | - The decrease in interest expense was due to the full repayment of senior convertible promissory notes on March 1, 2024[165](index=165&type=chunk) [Change in Fair Value of Common Stock Warrant Liability](index=30&type=section&id=Change%20in%20Fair%20Value%20of%20Common%20Stock%20Warrant%20Liability) The company recorded a gain of **$1.8 million** for H1 2025 from the revaluation of its common stock warrant liability, reflecting changes in fair value | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :----------------------------------------- | :------------------------------- | :----------------------------- | | Change in fair value of common stock warrant liability | $(1,878,010) | $1,834,862 | - The change in fair value of the common stock warrant liability is related to the revaluation of warrants issued in December 2024[166](index=166&type=chunk) [Gain (loss) on investment in affiliated entity](index=30&type=section&id=Gain%20%28loss%29%20on%20investment%20in%20affiliated%20entity) Recognized a gain on its investment in Plumbline Life Sciences (PLS) for Q2 2025 and H1 2025, reversing prior year losses, due to changes in PLS's market value | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | Gain (loss) on investment in affiliated entity | $776,000 | $(334,000) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Gain (loss) on investment in affiliated entity | $1.5 million | $(460,000) | - The gain/loss resulted from changes in the fair market value of the investment in Plumbline Life Sciences, Inc. (PLS)[167](index=167&type=chunk) [Net unrealized gain (loss) on available-for-sale equity securities](index=30&type=section&id=Net%20unrealized%20gain%20%28loss%29%20on%20available-for-sale%20equity%20securities) Reported net unrealized gains on available-for-sale equity securities for Q2 2025 and H1 2025, compared to a loss and a gain in the prior year, reflecting market value fluctuations | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------------- | :------------------------------- | :------------------------------- | | Net unrealized gain (loss) on available-for-sale equity securities | $759,000 | $(21,000) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------------- | :----------------------------- | :----------------------------- | | Net unrealized gain (loss) on available-for-sale equity securities | $900,000 | $480,000 | [Other (expense) income, net](index=30&type=section&id=Other%20%28expense%29%20income%2C%20net) Other (expense) income, net, primarily reflected realized losses on short-term investments sold, resulting in net expenses for Q2 2025 and H1 2025 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | | Other (expense) income, net | $(703,000) | $8,000 | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Other (expense) income, net | $(704,000) | $(675,000) | - The net expense was primarily related to realized losses on short-term investments sold[169](index=169&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's liquidity position, cash flow activities, and capital raising efforts, reiterating substantial doubt about its ability to continue as a going concern beyond Q2 2026 without additional financing [Working Capital and Liquidity](index=31&type=section&id=Working%20Capital%20and%20Liquidity) Working capital and cash, cash equivalents, and short-term investments significantly decreased from December 31, 2024, to June 30, 2025, indicating tightening liquidity | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and short-term investments | $47.5 million | $94.1 million | | Working capital | $21.0 million | $62.5 million | [Cash Flows](index=31&type=section&id=Cash%20Flows) Operating cash flows decreased, investing activities provided less cash, and financing activities saw a substantial decrease in cash provided, reflecting changes in debt repayment and equity offerings [Operating Activities](index=31&type=section&id=Operating%20Activities) Net cash used in operating activities decreased for H1 2025 compared to 2024, primarily due to timing and changes in working capital balances, offset by decreased operating expenses | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(47.7) million | $(57.0) million | [Investing Activities](index=31&type=section&id=Investing%20Activities) Net cash provided by investing activities significantly decreased for H1 2025 compared to 2024, mainly due to timing differences and an overall decrease in short-term investment purchases, sales, and maturities | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash provided by investing activities | $5.2 million | $55.3 million | [Financing Activities](index=31&type=section&id=Financing%20Activities) Net cash provided by financing activities decreased substantially for H1 2025 compared to 2024, primarily due to convertible senior note repayment in 2024 and lower equity offering proceeds | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash provided by financing activities | $993,000 | $21.7 million | - The variance was primarily due to the repayment of **$16.4 million** in convertible senior notes in March 2024 and lower net proceeds from equity offerings in 2025[177](index=177&type=chunk) [Offering of Common Stock and Warrants](index=31&type=section&id=Offering%20of%20Common%20Stock%20and%20Warrants) Completed a public offering in July 2025, raising **$22.5 million** net, and a December 2024 offering, raising **$27.6 million** net, through common stock and warrant issuance - The July 2025 Offering generated **$22.5 million** in net proceeds from the sale of **14,285,715 shares** of common stock and accompanying warrants[178](index=178&type=chunk) - The December 2024 Offering generated **$27.6 million** in net proceeds from the sale of **10,000,000 shares** of common stock and accompanying warrants[179](index=179&type=chunk) [Offering of Common Stock and Pre-Funded Warrants](index=31&type=section&id=Offering%20of%20Common%20Stock%20and%20Pre-Funded%20Warrants) In April 2024, the company completed a registered direct offering of common stock and pre-funded warrants, yielding **$33.2 million** in net proceeds - The April 2024 Offering generated **$33.2 million** in net proceeds from the sale of **2,536,258 shares** of common stock and **2,135,477 pre-funded warrants**[180](index=180&type=chunk) [At-The-Market Sales Agreements](index=31&type=section&id=At-The-Market%20Sales%20Agreements) Utilized ATM sales agreements, selling **518,670 shares** for **$1.1 million** net proceeds in H1 2025 under the 2024 Sales Agreement, with **$57.9 million** remaining capacity; the 2021 Sales Agreement was terminated in August 2024 - During the six months ended June 30, 2025, **518,670 shares** were sold under the 2024 Sales Agreement, generating **$1.1 million** in net proceeds[182](index=182&type=chunk) - As of June 30, 2025, **$57.9 million** of capacity remained under the 2024 Sales Agreement[183](index=183&type=chunk) - The 2021 Sales Agreement was terminated in August 2024[184](index=184&type=chunk) [Other Issuances of Common Stock](index=32&type=section&id=Other%20Issuances%20of%20Common%20Stock) In H1 2025, no stock options were exercised, and **$109,000** in tax payments were made for RSU settlements; in H1 2024, stock options generated **$68,000**, offset by **$414,000** in RSU settlement tax payments - During the six months ended June 30, 2025, no stock options were exercised, and **$109,000** in tax payments were made for RSU settlements[185](index=185&type=chunk) - During the six months ended June 30, 2024, stock option exercises generated **$68,000**, offset by **$414,000** in tax payments for RSU settlements[185](index=185&type=chunk) [Funding Requirements](index=32&type=section&id=Funding%20Requirements) The company has an accumulated deficit of **$1.8 billion** and expects continued losses; current cash, including recent offerings, funds operations into Q2 2026, but substantial additional financing is required, raising doubt about going concern ability - As of June 30, 2025, the company had an accumulated deficit of **$1.8 billion** and expects continued operating losses[186](index=186&type=chunk) - Current cash resources, including the July 2025 Offering proceeds, are expected to fund operations into the second quarter of 2026[186](index=186&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern beyond Q2 2026 without additional capital[187](index=187&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Discusses the company's exposure to market risks, including interest rate, foreign currency, and inflation risks, and their potential impact on financial condition and results of operations [Interest Rate Risk](index=32&type=section&id=Interest%20Rate%20Risk) Primary market risk is interest rate sensitivity, leading to an accumulated unrealized loss of **$945,000** in its investment portfolio as of June 30, 2025, due to rising U.S. interest rates - Primary market risk is interest rate sensitivity, affected by changes in U.S. interest rates[190](index=190&type=chunk) - Accumulated unrealized loss of **$945,000** in the investment portfolio as of June 30, 2025, due to increased prevailing interest rates[190](index=190&type=chunk) [Foreign Currency Risk](index=32&type=section&id=Foreign%20Currency%20Risk) Limited material exposure to foreign currency fluctuations, primarily from South Korean Won-denominated cash and equity investments, and transactions in Euros, British Pounds, and Canadian Dollars; no derivative instruments are used for hedging - Limited material exposure to foreign currency rate fluctuations, primarily from South Korean Won-denominated cash and equity investments in PLS[191](index=191&type=chunk) - Certain transactions are denominated in South Korean Won, Euros, British Pounds, and Canadian Dollars[192](index=192&type=chunk) - The company does not use derivative financial instruments for speculative purposes or engage in exchange rate hedging[193](index=193&type=chunk) [Inflation Risk](index=33&type=section&id=Inflation%20Risk) While U.S. inflation has increased, the company does not believe it had a material effect on its business, financial condition, or results of operations during H1 2025 - Inflation generally affects the company by increasing its cost of labor[194](index=194&type=chunk) - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the six months ended June 30, 2025[194](index=194&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Confirms the effectiveness of disclosure controls and procedures as of June 30, 2025, and reports no material changes in internal control over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=33&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) CEO and CFO concluded disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025, ensuring timely and accurate reporting - Disclosure controls and procedures are designed to ensure timely and accurate reporting of information required under the Securities Exchange Act of 1934[195](index=195&type=chunk) - The CEO and CFO concluded that disclosure controls and procedures were effective as of June 30, 2025, at the reasonable assurance level[197](index=197&type=chunk) [Changes in Internal Control over Financial Reporting](index=33&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in internal control over financial reporting occurred during Q2 2025 that materially affected, or are reasonably likely to materially affect, its internal control over financial reporting - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[198](index=198&type=chunk) Part II. Other Information [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) Provides updates on the company's legal proceedings, specifically detailing the ongoing VGXI litigation and the recently settled GeneOne litigation [VGXI Litigation](index=34&type=section&id=VGXI%20Litigation) Actively prosecuting a complaint against VGXI, Inc. for alleged material breach of a supply agreement and vigorously defending against VGXI's counterclaims, with no trial date set - In June 2020, the company filed a complaint against VGXI, Inc. alleging material breach of a supply agreement[200](index=200&type=chunk) - VGXI filed counterclaims in July 2020, alleging breach of supply agreement, misappropriation of trade secrets, and unjust enrichment[201](index=201&type=chunk) - The company intends to aggressively prosecute its claims and vigorously defend against counterclaims; a trial date has not been set[202](index=202&type=chunk) [GeneOne Litigation](index=34&type=section&id=GeneOne%20Litigation) Litigation with GeneOne, concerning a breached CELLECTRA Device License Agreement, was settled on August 1, 2025, through a Settlement Agreement and Mutual Release - GeneOne filed a complaint in December 2020, alleging breach of the CELLECTRA Device License Agreement[203](index=203&type=chunk) - The company filed counterclaims alleging GeneOne breached the agreement[203](index=203&type=chunk) - On August 1, 2025, the company and GeneOne entered into a Settlement Agreement and Mutual Release to settle all claims[204](index=204&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Details numerous risks that could adversely affect the company's business, financial condition, results of operations, cash flows, and prospects, categorized into financial, product development, third-party reliance, commercialization, operational, intellectual property, and investment-related risks [Risks Related to Our Financial Position and Need for Additional Capital](index=34&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) Faces significant financial risks, including substantial losses, limited revenue, and ongoing need for additional capital, raising substantial doubt about going concern beyond Q2 2026 without further financing, which may be difficult or costly and could dilute stockholders - The company has incurred significant operating losses and had an accumulated deficit of **$1.8 billion** as of June 30, 2025[206](index=206&type=chunk) - Success is dependent on developing DNA medicines and proprietary device technology, with limited current revenue from product sales[207](index=207&type=chunk) - Substantial additional capital is needed for R&D, regulatory approvals, and commercialization, which may be difficult or costly to obtain and could dilute existing stockholders[209](index=209&type=chunk)[210](index=210&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern beyond Q2 2026[215](index=215&type=chunk) [Risks Related to Product Development, Manufacturing and Regulatory Approval](index=36&type=section&id=Risks%20Related%20to%20Product%20Development%2C%20Manufacturing%20and%20Regulatory%20Approval) Faces substantial risks in product development, manufacturing, and regulatory approval, including complex drug-device products, uncertain clinical trials, negative public perception of DNA medicines, reliance on single-source suppliers, and ongoing regulatory obligations that could delay or prevent commercialization - Failure to obtain FDA approval for proprietary devices and DNA medicine candidates, especially for complex drug-device combination products, will prevent commercialization in the U.S[217](index=217&type=chunk)[218](index=218&type=chunk)[219](index=219&type=chunk) - Clinical trials are lengthy, expensive, and uncertain, with results from earlier studies not always predictive of later stages, and delays can increase costs and hinder revenue generation[230](index=230&type=chunk)[231](index=231&type=chunk) - Negative public perception of DNA medicines or CELLECTRA devices could adversely affect business, regulatory approvals, and demand[243](index=243&type=chunk)[244](index=244&type=chunk) - Reliance on contract manufacturers and single-source suppliers for devices and DNA medicine candidates poses risks of production difficulties, delays, and non-compliance with stringent regulations[245](index=245&type=chunk)[252](index=252&type=chunk) - Even with regulatory approval, ongoing obligations and potential policy changes (e.g., Loper Bright decision) could result in significant additional expense or penalties[255](index=255&type=chunk)[258](index=258&type=chunk) [Risks Related to Reliance on Third Parties](index=44&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) Success relies heavily on third-party collaborators for development, manufacturing, and clinical trials; loss of these relationships, inadequate partner resources, or disputes could severely impact product development and profitability, with government agreements also posing termination and funding risks, and indemnification provisions creating financial exposure - Loss of collaborators or partners, or their failure to apply adequate resources, could harm product development and profitability, including delays in event-based, milestone, or royalty payments[266](index=266&type=chunk)[267](index=267&type=chunk) - Agreements with government agencies are subject to termination and uncertain future funding, which could negatively impact pipeline development or require alternative funding[270](index=270&type=chunk) - Reliance on third-party CROs for clinical trials means delays or failures in their contractual duties could prevent regulatory approval or commercialization[272](index=272&type=chunk)[273](index=273&type=chunk) - Indemnification provisions in various contracts could lead to material adverse effects if obligations exceed insurance coverage or if third parties fail to indemnify[274](index=274&type=chunk)[275](index=275&type=chunk) [Risks Related to Commercialization of Our DNA Medicine Candidates](index=46&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20DNA%20Medicine%20Candidates) Commercialization risks include lacking an established sales organization, needing to build or partner for marketing/sales, and uncertainty of market acceptance and favorable reimbursement for novel DNA medicines; healthcare reform and cost containment efforts could also hinder success - The company has a small marketing organization and no sales organization, requiring significant investment or third-party partnerships to commercialize approved products[276](index=276&type=chunk) - Commercial success depends on broad market acceptance by the medical community and patients, influenced by factors like safety, efficacy, convenience, pricing, and reimbursement[277](index=277&type=chunk) - Uncertainty regarding coverage and reimbursement policies from third-party payors could hinder or prevent commercial success, as adequate reimbursement is crucial for product adoption[279](index=279&type=chunk)[282](index=282&type=chunk) - Healthcare reform measures (e.g., ACA, IRA) and governmental scrutiny of pharmaceutical pricing could adversely affect product pricing, revenue generation, and profitability[314](index=314&type=chunk)[319](index=319&type=chunk) [Risks Related to Employee and Operational Matters](index=47&type=section&id=Risks%20Related%20to%20Employee%20and%20Operational%20Matters) Operational risks include potential litigation, dependence on key personnel, health epidemics, intense competition, and challenges in acquiring/developing new candidates. Also faces risks from IT system compromises, healthcare regulation compliance, hazardous materials, and geopolitical factors affecting international collaborations and supply chains - The company is subject to litigation, including shareholder actions and disputes with third parties, which could result in substantial damages, legal expenses, and reputational harm[286](index=286&type=chunk)[287](index=287&type=chunk) - Success depends on retaining key personnel and attracting additional qualified staff, with intense competition for talent[288](index=288&type=chunk) - Health epidemics (e.g., COVID-19) can adversely affect clinical trial operations, manufacturing, and supply chains[289](index=289&type=chunk)[290](index=290&type=chunk) - Intense competition from larger pharmaceutical companies and disruptive technologies may impede development and commercialization of DNA medicines[291](index=291&type=chunk)[292](index=292&type=chunk) - Compromises to information technology systems or data, including cyber-attacks and AI/ML related risks, could lead to adverse business consequences, financial losses, and reputational harm[302](index=302&type=chunk)[305](index=305&type=chunk)[308](index=308&type=chunk) - Failure to comply with stringent federal, state, local, and foreign healthcare laws and regulations (e.g., Anti-Kickback Statute, False Claims Act, HIPAA) could result in significant penalties and adversely affect business operations[321](index=321&type=chunk)[324](index=324&type=chunk) - Collaborations with Chinese companies and reliance on Chinese-manufactured materials expose the company to uncertainties in Chinese laws, trade wars, political unrest, and potential U.S. trade restrictions (e.g., BIOSECURE Act)[328](index=328&type=chunk)[329](index=329&type=chunk) [Risks Related to Our Intellectual Property](index=55&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Faces challenges in generating and protecting intellectual property (IP), including uncertain patent protection in biotechnology, potential for third-party infringement claims, and difficulties in safeguarding trade secrets; failure to secure or defend IP rights could impair competitiveness and revenue - It is difficult and costly to generate and protect intellectual property, with patent positions in biotechnology being highly uncertain and subject to evolving laws and interpretations[339](index=339&type=chunk)[340](index=340&type=chunk) - The company relies on licensors and collaborators to protect some IP rights, and their failure to do so could harm the business[341](index=341&type=chunk) - Trade secrets are difficult to protect and may be unintentionally or willfully disclosed, or independently developed by competitors[342](index=342&type=chunk) - Being sued for infringing third-party intellectual property rights would be costly, time-consuming, and could lead to substantial damages, injunctions, or the need to redesign products[347](index=347&type=chunk)[349](index=349&type=chunk) - Failure to register trademarks in all potential markets could adversely affect the ability to enforce them against third parties[350](index=350&type=chunk) [Risks Related to an Investment in Our Common Stock](index=57&type=section&id=Risks%20Related%20to%20an%20Investment%20in%20Our%20Common%20Stock) Investment risks include common stock price volatility, broad management discretion in capital use, anti-takeover provisions limiting market price, and absence of cash dividends; ability to utilize net operating loss carryforwards may also be limited - The price of the common stock has been and may continue to be highly volatile, subject to substantial drops, and influenced by numerous factors beyond the company's control[352](index=352&type=chunk)[357](index=357&type=chunk) - Management has broad discretion in using cash, cash equivalents, and investments, which may not always improve operating results or stock value[355](index=355&type=chunk) - Anti-takeover provisions in charter documents and Delaware law could delay or prevent a change of control, potentially limiting the market price of common stock[356](index=356&type=chunk)[358](index=358&type=chunk) - The company has never paid cash dividends and does not anticipate doing so in the foreseeable future, making capital appreciation the sole source of potential gain[360](index=360&type=chunk) - The ability to utilize net operating loss carryforwards and other tax attributes may be limited by ownership changes or changes in tax laws[361](index=361&type=chunk) [General Risk Factors](index=59&type=section&id=General%20Risk%20Factors) General risks include significant quarterly operating result fluctuations, material impacts from market/economic conditions, adverse financial services developments, potential stock price decline from lack of analyst coverage, dilution from additional stock issuances, and increased public company costs/demands. Changes in tax laws and social media challenges also pose risks - Quarterly operating results may fluctuate significantly due to various factors, and comparisons are not necessarily meaningful for future performance[362](index=362&type=chunk) - Market fluctuations and general economic conditions (e.g., inflation, rising interest rates, geopolitical issues) could materially affect operations and liquidity[363](index=363&type=chunk) - Adverse developments in the financial services industry, such as bank failures, could impact access to capital and liquidity[366](index=366&type=chunk) - Lack of equity research analyst coverage or unfavorable reports could cause stock price and trading volume to decline[367](index=367&type=chunk) - Issuance of additional stock for fin