Inovio Pharmaceuticals(INO) - 2025 Q2 - Quarterly Results

Executive Summary 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 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] - Potential INO-3107 approval date is anticipated in mid-2026[3] Operational Highlights 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) 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 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][5] - Requested rolling submission from the US FDA for INO-3107 in July 2025, leveraging its Breakthrough Therapy designation[4][5] - Continuing to advance commercial preparations for the potential launch of INO-3107 in 2026, if approved by the FDA[5] Clinical Data and Efficacy 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][6] - Patients experiencing a 50-100% reduction in surgeries (Overall Response Rate) increased from 72% at Year 1 to 86% at Year 2[9] - Patients achieving a Complete Response (0 surgeries per year) increased from 28% for Year 1 to 50% for Year 2[9] - Mean number of surgeries reduced from 4.1 (pre-treatment) to 1.7 (Year 1) and further to 0.9 (Year 2)[9] - INO-3107 was well tolerated, with no serious adverse events or long-term safety concerns identified[9] Next Generation DNA Medicine Candidates 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] - Data included key insights from an ongoing Phase 1 proof-of-concept trial evaluating DNA-encoded monoclonal antibodies (DMAbs) for COVID-19[6] - Provided an overview of DNA-encoded protein technology (DPROT) that targets long-term protein expression[6] General Corporate Developments 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] - Strengthened its balance sheet with an underwritten public offering of common stock and warrants in July 2025[7] - Net proceeds from the July 2025 offering were approximately $22.5 million[7] Upcoming Presentations 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][10] Second Quarter 2025 Financial Performance 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 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 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] General and Administrative (G&A) Expenses 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] Cash, Cash Equivalents and Investments 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][17] Cash Guidance and Runway 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] - Operational net cash burn estimate for the third quarter of 2025 is approximately $22 million[13] Consolidated Financial Statements 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 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 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 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 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] - DNA plasmids function like software, allowing the body's cells to produce specific proteins to target and fight disease[15] - CELLECTRA delivery devices are designed to optimally deliver DNA medicines without chemical adjuvants, lipid nanoparticles, or the risk of anti-vector response[15] About INOVIO 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] - Its DNA medicines aim to treat and protect people from HPV-related diseases, cancer, and infectious diseases[16] - The technology optimizes the design and delivery of DNA medicines to teach the body to manufacture its own disease-fighting tools[16] Important Disclosures This section includes important forward-looking statements regarding INOVIO's business and provides contact information for media and investor inquiries Forward-Looking Statements 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] - 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] Contacts Contact information is provided for media and investor relations inquiries - Media Contact: Jennie Willson, (267) 429-8567, communications@inovio.com[19] - Investors Contact: Peter Vozzo - ICR Healthcare, (443) 213-0505, investor.relations@inovio.com[19]