Inovio Pharmaceuticals(INO)
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Clinical Proof-of-Concept Data for DNA-Encoded Monoclonal Antibodies (DMAbs) Published in Nature Medicine
Prnewswire· 2025-10-21 12:05
Core Insights - INOVIO announced results from a Phase 1 trial evaluating DNA-encoded monoclonal antibodies (DMAbs) for COVID-19, published in Nature Medicine, demonstrating the potential of DMAbs as a long-acting alternative to traditional monoclonal antibody delivery [1][2][4] Phase 1 Trial Summary - The trial involved 39 participants, all of whom maintained biologically relevant levels of DMAbs through a 72-week follow-up, confirming the durability of in vivo antibody production [2][4] - DMAbs successfully bound to the SARS-CoV-2 Spike protein and neutralized the SARS-CoV-2 pseudovirus in all tested participants, confirming functional activity [2][7] - No participants developed anti-drug antibodies (ADA), a common issue in other gene-based delivery platforms, and the DMAbs were well tolerated with mild, temporary injection site reactions being the most common side effects [2][4][7] Technology and Methodology - The trial utilized synthetic DNA technology to enable in vivo production of monoclonal antibodies directly from muscle cells, delivered via INOVIO's CELLECTRA 2000 electroporation device [3][5] - The study was an open-label, single-center, dose-escalation trial, with primary endpoints focused on safety and pharmacokinetics [4] Results and Observations - DMAbs were detected in 100% of evaluable participants, with serum concentrations peaking at 1.61 g/mL, and sustained expression was observed throughout the follow-up period [4][7] - The most common side effects were mild, temporary injection site reactions, and there were three serious adverse events (SAEs) reported, all deemed unrelated to the study product [4][7] Company Overview - INOVIO is a biotechnology company focused on developing and commercializing DNA medicines aimed at treating HPV-related diseases, cancer, and infectious diseases [6][8] - The company's DNA medicines platform includes precisely designed DNA plasmids and proprietary delivery devices, optimizing the design and delivery of innovative DNA medicines [5][8]
INOVIO to Participate in Upcoming Scientific Conferences
Prnewswire· 2025-09-25 12:05
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].
Inovio Pharmaceuticals, Inc. (INO) Presents At H.C. Wainwright 27th Annual Global Investment Conference (Transcript)
Seeking Alpha· 2025-09-05 13:37
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]
Inovio Pharmaceuticals (INO) FY Conference Transcript
2025-09-05 12:00
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]
INO Stock Soars as FDA Backs Rolling BLA for Rare Lung Disease Drug
ZACKS· 2025-08-28 15:01
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]
INOVIO to Begin Rolling Submission of BLA for INO-3107 for the Treatment of RRP in Adults
Prnewswire· 2025-08-26 12:05
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]
INOVIO to Participate in the H.C. Wainwright 27th Annual Global Investment Conference
Prnewswire· 2025-08-25 12:05
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]
Inovio Pharmaceuticals(INO) - 2025 Q2 - Earnings Call Transcript
2025-08-12 21:30
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]
Inovio Pharmaceuticals(INO) - 2025 Q2 - Quarterly Results
2025-08-12 20:08
[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)
INOVIO Reports Second Quarter 2025 Financial Results and Recent Business Highlights
Prnewswire· 2025-08-12 20:05
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]