Core Insights - INOVIO is focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases, and will present at several upcoming conferences to share new data on its lead candidate INO-3107 [1][4] Conference Presentations - INOVIO will participate in the Citizens JMP Life Sciences Conference on May 8, featuring a fireside chat format [2] - At the European Laryngological Society Annual Congress on May 9, INOVIO will present data showing that INO-3107 generates a targeted immunologic response, resulting in surgery reduction for 81% of adults with recurrent respiratory papillomatosis in the first year [2] - The American Society of Gene and Cell Therapy will host a poster abstract session on May 13, discussing the successful treatment of recurrent respiratory papillomatosis with INO-3107, regardless of papilloma microenvironment and molecular subtype [2] - An oral presentation at the ABEA program during the COSM on May 15 will focus on the durability and long-term clinical effects of INO-3107 in treating recurrent respiratory papillomatosis caused by HPV types 6 and 11 [3] Company Overview - INOVIO is a biotechnology company that specializes in the design and delivery of innovative DNA medicines, aiming to empower the body to produce its own disease-fighting tools [4]

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancers, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease- fighting tools. For more information, visit www.inovio.com. Contacts Media: Jennie Willson, (267) 429-8567, [email protected] Investors: Peter Vozzo - ICR Healthcare, (443) 213-0505, [email prot ...

Investors might want to bet on Inovio Pharmaceuticals (INO) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a changing ...

Core Viewpoint - Inovio Pharmaceuticals (INO) has experienced significant selling pressure, resulting in an 11.4% decline over the past four weeks, but analysts anticipate improved earnings in the near future [1] Group 1: Technical Analysis - The Relative Strength Index (RSI) is utilized to identify oversold stocks, with a reading below 30 indicating oversold conditions [2] - INO's current RSI reading is 25.47, suggesting that the heavy selling may be nearing exhaustion, potentially leading to a price rebound [5] Group 2: Fundamental Analysis - There is a strong consensus among sell-side analysts to raise earnings estimates for INO, with a 33.4% increase in the consensus EPS estimate over the last 30 days [7] - INO holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, indicating a favorable outlook for a potential turnaround [8]

Inovio Pharmaceuticals (INO) Q4 2024 Earnings Call March 19, 2025 01:35 AM ET Company Participants Jennie Willson - IR & MediaJacqueline Shea - CEO, President & DirectorMichael Sumner - Chief Medical OfficerSteve Egge - CCOPeter Kies - CFOAnish Nikhanj - Senior Associate - Biotechnology Equity ResearchLiang Cheng - Senior Research Associate Conference Call Participants Roy Buchanan - Equity Research AnalystJay Olson - Managing Director & Senior Analyst - BiotechnologySudan Loganathan - AnalystYi Chen - Mana ...

Fourth Quarter & Full Year 2024 Financial Results • March 2025 Agenda Introduction Jennie Willson, Director, Communications CEO Perspective & Corporate Progress Jacqueline Shea, PhD, President & Chief Executive Officer INO-3107 Update Michael Sumner, MBBS, MBA, Chief Medical Officer Steve Egge, Chief Commercial Officer Financial Results Peter Kies, Chief Financial Officer 2 Forward-Looking Statements This presentation includes statements that are, or may be deemed, "forward-looking statements," within the m ...

Financial Performance - Total revenues for the year ended December 31, 2024, were $218,000, a decrease from $832,000 in 2023[11] - Total revenue for the year ended December 31, 2024, was $217,756, a decrease of 73.8% compared to $832,010 in 2023[25] - INOVIO's net loss for the year ended December 31, 2024, was $107.3 million, or $3.95 per share, compared to a net loss of $135.1 million, or $6.09 per share, in 2023[19] - Net loss for 2024 was $107,254,126, compared to a net loss of $135,117,352 in 2023, indicating an improvement of 20.7%[25] - The company reported a basic and diluted net loss per share of $3.95 in 2024, an improvement from $6.09 in 2023[25] Expenses - Research and Development (R&D) expenses for the year ended December 31, 2024, were $75.6 million, down from $86.7 million in 2023[11] - Research and development expenses were $75,620,340 in 2024, down from $86,676,563 in 2023, a decrease of 12.8%[25] - General and Administrative (G&A) expenses for the year ended December 31, 2024, were $37.0 million, compared to $47.6 million in 2023[11] - General and administrative expenses decreased to $36,996,338 in 2024 from $47,582,104 in 2023, a reduction of 22.2%[25] - Total operating expenses decreased to $112,616,678 in 2024 from $144,772,038 in 2023, representing a reduction of 22.2%[25] Cash and Assets - Cash, cash equivalents, and short-term investments as of December 31, 2024, were $94.1 million, down from $145.3 million as of December 31, 2023[11] - Cash and cash equivalents increased to $65,813,297 in 2024 from $14,310,862 in 2023, showing a significant increase of 359.5%[23] - Total assets decreased to $113,197,206 in 2024 from $170,951,423 in 2023, a decline of 33.8%[23] - Total liabilities decreased to $44,693,411 in 2024 from $53,602,294 in 2023, a reduction of 16.5%[23] Clinical Development - INOVIO anticipates starting the rolling submission of its first Biologics License Application (BLA) for INO-3107 in mid-2025, aiming for complete submission acceptance by the end of 2025[3] - In a retrospective study, 50% of patients treated with INO-3107 achieved a Complete Response in the second 12-month period, with 86% showing a reduction in surgery of 50% or greater[5] - INOVIO plans to advance development for a Phase 3 trial for INO-3112 in combination with LOQTORZI, having gained alignment with the FDA on the trial design[11] Manufacturing and Operational Insights - The company has made significant progress in resolving manufacturing issues related to the CELLECTRA device, enabling the final step of FDA-required device verification testing[8] - INOVIO estimates an operational net cash burn of approximately $27 million for the first quarter of 2025[14] - The weighted average number of common shares outstanding increased to 27,160,863 in 2024 from 22,173,662 in 2023[25]

Core Insights - INOVIO is progressing towards submitting its first Biologics License Application (BLA) for INO-3107, targeting recurrent respiratory papillomatosis (RRP), with plans to start the submission process in mid-2025 and aim for priority review by the end of the year [2][4][9] Operational Highlights - The company resolved a manufacturing issue related to the CELLECTRA device, allowing for the completion of non-device BLA modules [4][5] - A retrospective study indicated that 50% of RRP patients treated with INO-3107 achieved a complete response in the second year, with 86% showing a significant reduction in surgery needs [4][5] - Interim results from a Phase 1 trial of DNA-encoded monoclonal antibodies (DMAb) targeting COVID-19 demonstrated well-tolerated and durable in vivo antibody production [4][5] Financial Results - As of December 31, 2024, INOVIO reported total revenues of $218,000, a decrease from $832,000 in 2023 [15] - Research and Development (R&D) expenses for 2024 were $75.6 million, down from $86.7 million in 2023, attributed to lower employee compensation and clinical trial expenses [15] - The net loss for the year was $107.3 million, or $3.95 per share, compared to a net loss of $135.1 million, or $6.09 per share, in 2023 [15][19] Cash Position - INOVIO's cash, cash equivalents, and short-term investments totaled $94.1 million as of December 31, 2024, down from $145.3 million in 2023 [15] - The company anticipates a net cash burn of approximately $27 million for the first quarter of 2025, projecting sufficient cash to support operations into the first quarter of 2026 [12]

Clinical Trials and Drug Development - INOVIO Pharmaceuticals reported that 81.3% of participants in the Phase 1/2 trial of INO-3107 experienced a reduction in surgical interventions compared to the year prior[18]. - The median number of surgeries for participants decreased by three in the year following treatment with INO-3107, with a median of four surgeries in the year prior[19]. - INO-3107 received FDA feedback indicating that data from the completed trial could support a Biologic License Application (BLA) submission under the accelerated approval program, with a rolling submission expected to begin in mid-2025[19]. - INOVIO is developing INO-3112 for HPV 16/18 positive oropharyngeal squamous cell carcinoma, with an estimated 20,000 new cases annually in the U.S.[20]. - A clinical collaboration with Coherus BioSciences has been established to evaluate the combination of INO-3112 and LOQTORZI in a planned Phase 3 trial[21]. - INOVIO is also developing INO-5401 for glioblastoma multiforme, with nearly 15,000 expected diagnoses in the U.S. in 2023[22]. - INO-3107 demonstrated an 81.3% reduction in surgical interventions in the year following administration compared to the prior year, with 28.1% of patients requiring no surgery during or after the dosing window[43]. - The median decrease in surgical interventions after INO-3107 treatment was statistically significant at 3 surgeries, with a 95% confidence interval of -3 to -2[43]. - INO-3112 showed an overall response rate of 27.6% in a Phase 1b/2a trial, with a median overall survival of over 29 months, significantly improving upon historical data for similar treatments[47]. - The company announced the discontinuance of the U.S. development program for VGX-3100 for HPV-related cervical HSIL after failing to achieve statistical significance in the biomarker-selected population[49]. - VGX-3100 demonstrated statistical significance for lesion regression and viral clearance in the all-participants population across two Phase 3 trials[50]. - In a Phase 2 clinical trial (HPV-203), 50% of the 22 participants treated with VGX-3100 showed resolution of HPV-16/18-associated anal HSIL at six months[55]. - A separate Phase 2 trial of VGX-3100 has enrolled approximately 90 HIV-positive participants, evaluating histological regression of high-grade anal lesions[56]. - INO-5401, in combination with INO-9012 and Libtayo, demonstrated a median overall survival of 32.5 months for patients with an MGMT methylated promoter[60]. - The ongoing Phase 3 trial of VGX-3100 in China (HPV-303CHN) began dosing participants in 2021[80]. Regulatory and Approval Processes - INO-3107 received Orphan Drug Designation in July 2020 and Breakthrough Therapy Designation in 2023 from the FDA, indicating its potential for significant clinical benefit[46]. - CELLECTRA devices are CE-marked in the EU, allowing for commercialization in regions recognizing CE-marking[34]. - The company plans to use the combined data from two Phase 3 trials of VGX-3100 as supportive data for future regulatory interactions[52]. - The FDA's accelerated approval program allows the use of data from completed Phase 1/2 trials for BLA submissions, which could expedite market entry[96]. - The FDA requires a Biologics License Application (BLA) for product candidates to be legally marketed in the U.S., which involves extensive pre-clinical and clinical testing[110]. - The BLA submission must include proof of safety, purity, potency, and efficacy, supported by comprehensive pre-clinical and clinical trial data[116]. - The FDA aims to review BLAs within ten months for standard review or six months for priority review, depending on the product's significance[119]. - The FDA may require post-approval trials (Phase 4) to further assess a product's safety and effectiveness after initial marketing approval[114]. - The FDA can impose clinical holds on product candidates at any time due to safety concerns or non-compliance during clinical trials[111]. - The Prescription Drug User Fee Act (PDUFA) mandates a user fee for each BLA, which is adjusted annually[117]. - The FDA may issue a Complete Response Letter if the BLA has deficiencies, requiring additional data or trials before approval[122]. - Companies must comply with current good manufacturing practices (cGMP) to ensure product quality and consistency during production[122]. - The FDA may require Risk Evaluation and Mitigation Strategies (REMS) for certain products to ensure safe use, which must be submitted as part of the BLA[123]. - The FDA offers expedited development and review designations such as fast track, breakthrough therapy, and priority review for products addressing unmet medical needs in serious diseases[125]. - Fast track designation allows for more frequent interactions with the FDA and rolling review of application sections, expediting the development process[126]. - Breakthrough therapy designation requires preliminary clinical evidence showing substantial improvement over existing therapies, leading to expedited development and review[127]. - Priority review designation shortens the FDA's review timeline from ten months to six months for drugs that significantly improve safety or effectiveness over existing therapies[128]. - Accelerated approval can be granted based on surrogate endpoints that predict clinical benefit, with post-marketing trials required to verify the drug's effectiveness[130]. - Orphan drug designation is available for products treating rare diseases, granting seven years of exclusivity if the product is the first approved for that condition[136]. - The FDA mandates post-marketing requirements, including monitoring adverse experiences and compliance with promotional standards[137]. - The Biologics Price Competition and Innovation Act allows for an abbreviated approval pathway for biosimilars, with 12 years of data exclusivity for reference products[141][143]. Financial Performance and Funding - Revenue from ApolloBio accounted for 100% in 2024 and 29% in 2023[157]. - Research and development expenses were $75.6 million in 2024, down from $86.7 million in 2023, indicating a decrease of approximately 12.8%[158]. - The company has no material exposure to foreign currency fluctuations, primarily operating in U.S. dollars, with some cash held in South Korean Won[434]. - An accumulated unrealized loss of $1.9 million in the investment portfolio was reported as of December 31, 2024, due to rising interest rates[433]. - The company received a $37.6 million grant from DARPA to develop anti-SARS-CoV-2-specific DMAbs using its DMAb technology[67]. - The ApolloBio Agreement allows the company to receive up to $20 million upon achieving specified milestones related to VGX-3100 regulatory approval[79]. Workforce and Operations - The company employs 134 full-time staff, with 99 in product research and development, and 35 in general and administrative functions[165]. - Approximately 50% of the workforce is comprised of women and individuals with ethnically diverse backgrounds[165]. - The company has invested in employee engagement initiatives to maintain a motivated workforce[167]. - The company’s long-lived assets are entirely located in the United States[159]. - The company is subject to various healthcare laws and regulations, which may impact its operations and compliance costs[154]. - The company relies on third-party manufacturers for clinical supplies, with service agreements in place with multiple manufacturers[90]. - Manufacturing processes for biological products are complex and highly regulated, which may lead to supply interruptions if issues arise with third-party manufacturers[92]. - The company intends to enter into arrangements with third-party commercial partners for product candidates that obtain marketing approval outside the United States[96]. Market and Competitive Landscape - The company faces competition from major biopharmaceutical companies and various development-stage biotechnology firms in the immunotherapy and vaccine sectors[82]. - Cost containment trends in the healthcare industry are leading to increased scrutiny of product effectiveness and pricing by third-party payors and government entities[148]. - Coverage and reimbursement decisions by third-party payors significantly impact the commercialization of pharmaceutical products, with no uniform policies across payors[144][146].

Core Insights - INOVIO announced promising interim results from a Phase 1 trial evaluating DNA-encoded monoclonal antibodies (DMAbs) for COVID-19, with 100% of participants maintaining biologically relevant levels of DMAbs at week 72 [1][4] - The trial demonstrated no development of anti-drug antibodies (ADA), a significant advantage over traditional gene-based delivery platforms [1][4] - The DMAbs were well tolerated, with mild, temporary injection site reactions being the most common side effects [1][4] Company Overview - INOVIO is a biotechnology company focused on developing DNA medicines to treat HPV-related diseases, cancer, and infectious diseases [7] - The company utilizes a proprietary DNA medicines platform that includes precisely designed DNA plasmids and the CELLECTRA® delivery device [6][7] Trial Details - The Phase 1 trial is the first clinical study using synthetic DNA technology for in vivo production of monoclonal antibodies directly from muscle cells [3] - Participants received intramuscular injections of synthetic DNA plasmids delivered via INOVIO's CELLECTRA 2000 electroporation device [3] - The trial is an open-label, single center, dose-escalation study that began enrollment in May 2022 and completed in March 2024 [4][5] Results Summary - All participants (n=24) who reached week 72 maintained stable DMAb levels [4] - No ADA formation was detected across approximately 1,000 blood samples, indicating a successful immune response [4] - The expressed DMAbs effectively bound to the SARS-CoV-2 Spike protein receptor-binding domain, confirming functional activity [4] Future Directions - A manuscript detailing the interim results has been uploaded for early dissemination and is under peer review for publication [2] - The consortium plans to present these interim results at scientific conferences in 2025 [2]