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Interested in Inovio Pharmaceuticals, Inc.? Here are five stocks we like better. INO-3107’s FDA review is nearing completion, with late-cycle review and pre-licensure inspections finished and the target action date still set for Oct. 30, 2026. The FDA has not yet decided whether the treatment qualifies for accelerated approval, while Inovio expects label discussions to begin in September. Inovio is preparing for a potential U.S. launch by selecting Syneos Health as its contract sales organization, developing targeted marketing and patient-support programs, and highlighting INO-3107’s potential advantages over surgery and competing treatments. The company ended Q2 with $36.7 million in cash and raised approximately $18.3 million through a July offering. Inovio expects its resources to fund operations into late Q1 2027, including pre-launch spending and a potential INO-3107 launch. Palantir Bulls Face a Reality Check Before Earnings Inovio Pharmaceuticals (NASDAQ:INO) said the U.S. Food and Drug Administration has completed several key steps in its review of the company’s biologics license application for INO-3107, an investigational treatment for recurrent respiratory papillomatosis, or RRP, while the company continues preparations for a potential commercial launch. The FDA’s target action date for the application remains Oct. 30, 2026. Chief Executive Officer Dr. Jacqueline Shea said the agency has completed its late-cycle review meeting and all scheduled pre-licensure inspections. Inovio also held a previously requested informal clinical meeting with the FDA in July to present its safety, efficacy and product-differentiation data. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat Let the Good Times Roll: 2 Stocks Showing No Signs of Slowing Chief Medical Officer Dr. Mike Sumner said the completed inspections covered clinical operations, drug manufacturing, in-house drug testing and the company’s delivery-device facility. He said inspectors reported one observation, which Inovio believes it has addressed and is responding to with the FDA. Sumner said the FDA did not provide a preliminary conclusion during the informal meeting on whether INO-3107 qualifies for accelerated approval, an issue identified in the agency’s December 2025 file-acceptance letter. The agency indicated that its review remains ongoing and that feedback on Inovio’s proposed confirmatory trial design is forthcoming. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be 3 AI Stocks in Correction Mode: Can They Rebound? Inovio believes INO-3107 meets accelerated-approval criteria because it could offer meaningful therapeutic benefit relative to existing treatments and address a continuing unmet need in RRP. The company cited phase I/II data in which it said most patients experienced a 50% to 100% reduction in surgeries during the first year, with continued improvement in the second year. Management also highlighted what it views as product advantages over Pepzimos, including that INO-3107 does not require patients to undergo scoping and surgery during its dosing window to maintain minimal residual disease. Sumner said Inovio expects to begin label negotiations in September and, if the product is approved, expects seven years of orphan-drug market exclusivity based on its delivery method and mechanism of action. → First Solar’s Profit Engine Faces a New Policy Test in Washington Chief Commercial Officer Steve Egge said Inovio has moved into the implementation phase of launch planning. The company has selected Syneos Health as its contract sales organization for a potential U.S. commercialization effort and plans targeted marketing efforts and a patient-support hub. Egge said early uptake of Pepzimos, with approximately 200 patients reportedly treated, validates demand for alternatives to surgery. He characterized that figure as low-single-digit penetration of the prevalent RRP patient population, leaving most patients open to new treatment options. Inovio said INO-3107’s potential commercial differentiation includes the absence of specialized ultra-cold-chain handling requirements, which management said could provide greater flexibility across care settings. The company is also initiating its medical science liaison team to begin scientific engagement with potential customers. Beyond INO-3107, Shea highlighted positive top-line phase III results announced by ApolloBio, Inovio’s Greater China partner for VGX-3100 in cervical dysplasia. According to Inovio, the study met its predefined primary efficacy endpoint of CIN 2 or CIN 3 lesion regression and HPV-16 and HPV-18 viral clearance, while demonstrating a favorable safety and tolerability profile. ApolloBio plans to use the results to support a future regulatory filing for VGX-3100 in China. Inovio said the results support the potential for DNA medicines to address HPV-related diseases while reducing or eliminating the need for surgical intervention. The company also presented preclinical research involving its DNA-encoded protein, or DPROT, platform targeting factor VIII production for hemophilia A at scientific conferences during the quarter. Inovio added Fabry disease and hypophosphatasia as rare-disease targets for the platform and said it is in discussions with potential partners to advance DPROT candidates. Chief Financial Officer Peter Kies said Inovio ended the second quarter with $36.7 million in cash, cash equivalents and short-term investments, compared with $58.5 million at Dec. 31, 2025. In late July, the company completed an underwritten public offering that generated approximately $18.3 million in net proceeds. Second-quarter operating expenses declined 19% year over year to $18.6 million from $23.1 million. Operating expenses for the first six months of 2026 decreased 16% from the prior-year period. Net loss was $6 million, or $0.07 per share, compared with a net loss of $23.5 million, or $0.61 per share, a year earlier. The lower net loss included a $13.9 million non-cash gain from the fair-value adjustment of warrant liabilities. Inovio estimated operational net cash burn of approximately $18 million for the third quarter and said its available resources, including the July offering proceeds, are expected to fund operations into late first quarter of 2027 and through a potential INO-3107 launch. Kies said that outlook includes expected pre-launch inventory-building and marketing costs during the fourth quarter and first quarter. Inovio Pharmaceuticals is a biotechnology company focused on the discovery, development and commercialization of DNA-based immunotherapies and vaccines aimed at treating and preventing infectious diseases and cancers. The company leverages proprietary technologies to design synthetic DNA sequences that encode antigens capable of eliciting targeted immune responses. Inovio's business activities span early research through clinical development, with a primary emphasis on advancing candidates against viral pathogens such as SARS-CoV-2, human papillomavirus (HPV), HIV, Ebola, Zika and other emerging threats. Central to Inovio's platform is its SynCon® technology, which constructs optimized DNA plasmids for broad antigen coverage, and the Cellectra® electroporation device, designed to enhance cellular uptake and expression of DNA vaccines. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Inovio Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management confirmed the FDA has completed all scheduled pre-licensure inspections, including clinical, manufacturing, and delivery device facilities, with only one observation reported and addressed. The company maintains that INO-3107 fulfills accelerated approval criteria by offering a meaningful therapeutic benefit over existing treatments through a differentiated mechanism of action not impacted by neutralizing antibodies. Strategic positioning of INO-3107 focuses on a 'patient-centric' approach that eliminates the requirement for surgical intervention during the dosing window, a key differentiator from the current standard of care. Operational focus has shifted toward commercial infrastructure, including the engagement of Syneos Health as a contract sales organization to support the anticipated U.S. launch. Positive Phase 3 data from partner ApolloBio in China for VGX-3100 serves as external validation of Inovio's DNA medicine platform's efficacy in treating HPV-related diseases. The company is expanding its DPROT technology platform into new rare disease targets, specifically Fabry disease and hypophosphatasia, to drive long-term portfolio growth through partnerships. Management anticipates entering label negotiations with the FDA in September 2026. ahead of the October 30 PDUFA target date. Cash runway is expected to extend into late Q1 2027, covering the projected launch period and including costs for pre-launch inventory and marketing spend. The company expects to receive seven years of orphan drug market exclusivity if approved, based on its unique delivery method and mechanism of action. Guidance for Q3 2026 estimates an operational net cash burn of $18 million as the company ramps up commercial workstreams. Management is awaiting FDA feedback on the confirmatory trial design but does not expect the trial's initiation timeline to impact the PDUFA date or approvability. A $13.9 million non-cash gain on fair value adjustment related to warrant liabilities significantly reduced the reported net loss for the quarter. The company completed an equity offering in July 2026, generating $18.3 million in net proceeds to support commercialization efforts. Management highlighted that the vast majority of the RRP market remains untapped, with current competitive penetration in the low single digits. Operating expenses decreased by 19% year-over-year, reflecting a strategic effort to consolidate resources toward the INO-3107 program. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management stated the meeting allowed them to present the totality of safety and efficacy data to new leadership at CBER and the Office of Therapeutic Products. The FDA did not disagree with Inovio's data positioning but declined to comment on accelerated approval eligibility as the file remains under active review. The company is still waiting for formal FDA comments on the submitted protocol but emphasized that this late-stage review step should not affect the PDUFA timeline. Discussions regarding the timing of the trial's commencement are ongoing with the agency. Management confirmed that current cash reserves are sufficient to reach the projected launch without immediate additional capital raises. The financial projections explicitly include 'baked-in' costs for pre-launch inventory building and launch-related marketing expenses through Q1 2027.

This article first appeared on GuruFocus. Cash and Investments: $36.7 million in cash, cash equivalents, and short-term investments as of June 30, 2026, down from $58.5 million at the end of 2025. Operating Expenses: $18.6 million in Q2 2026, a 19% decrease from $23.1 million in Q2 2025. Net Loss: $6.0 million, or $0.07 per share, in Q2 2026, compared to a net loss of $23.5 million, or $0.61 per share, in Q2 2025. Net Cash Burn Guidance: Approximately $18 million expected for Q3 2026. Capital Raise: Completed an equity offering in July 2026, generating approximately $18.3 million in net proceeds. Cash Runway: Expected to extend into late Q1 2027, through a potential launch of INO-3107. Warning! GuruFocus has detected 4 Warning Signs with INO. Is INO fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. INO-3107 is on track for the October 30, 2026 PDUFA date, with the FDA completing its late-cycle review and all pre-licensure inspections. INO-3107 demonstrated strong efficacy in clinical trials, with the majority of patients experiencing a 50-100% reduction in surgery in year one and continued improvement in year two. INO-3107 offers a differentiated safety profile, not requiring scoping and surgery during the dosing window, unlike existing treatments like papsimios. The company expects to receive seven years of orphan drug market exclusivity for INO-3107 if approved, providing a competitive advantage. Positive Phase 3 data from Apollo Bio for VGX-3100 in China validates the potential of Inovio's DNA medicine platform for HPV-related diseases. The company has strengthened its balance sheet with an $18.3 million equity offering, extending its cash runway into late first quarter 2027 and through a potential launch. Operating expenses decreased by 19% in Q2 2026 compared to the same period in 2025, reflecting disciplined cost management. The FDA has not yet provided preliminary conclusions on INO-3107's eligibility for accelerated approval, which remains a potential review issue. The company's cash runway extends only into late first quarter 2027, and further capital raising may be needed if launch is delayed or revenue is slower than expected. INO-3107 faces competition from papsimios, which has already been approved and has shown early uptake with approximately 200 patients treated. The company is still awaiting FDA feedback on the design of the confirmatory trial, which could impact timelines and resources. The net loss for Q2 2026 was $6 million, and the company continues to burn cash, with an estimated operational net cash burn of $18 million for Q3 2026. The company's reliance on partnerships, such as Apollo Bio for VGX-3100, means it has limited control over the development and commercialization of certain pipeline candidates. Q: Could you provide more detail on the INO-3107 informal clinical meeting with the FDA and whether any new efficacy, safety, or CMC-related questions were raised?A: Dr. Mike Sumner, Chief Medical Officer, stated that the FDA granted the meeting, allowing Inovio to present the entirety of the compelling efficacy and safety data for INO-3107. The FDA had already seen the data submitted during the review process, and they did not disagree with Inovio's positioning of the data. However, they were not in a position to comment on the accelerated approval eligibility question as the file is under active review. Q: Can you provide updates on the confirmatory trial design, including patient population, endpoints, and potential initiation following approval?A: Dr. Sumner noted that Inovio is still awaiting the FDA's comments on the submitted protocol to the IND. The FDA indicated during the informal meeting that comments would be forthcoming. While this is late in the review process, Inovio has no reason to believe that getting the trial up and running will impact approvability or the PDUFA date. Q: Should investors expect another capital raise before the PDUFA, or is the plan to bridge launch through revenue and financing partners?A: CEO Dr. Jackie Shea confirmed that the company is currently funded through late first quarter 2027, which is after the anticipated launch date. CFO Peter Kies added no further comment, affirming that the current funding is sufficient through the projected launch. Q: Does the first quarter 2027 runway projection bake in prelaunch inventory build and launch marketing spend, or does it assume a straight-to-launch scenario without those costs?A: CFO Peter Kies clarified that those costs are built into the projections throughout the fourth quarter and first quarter, confirming that the runway estimate includes the necessary prelaunch and launch expenses. Q: What are the key competitive advantages of INO-3107 compared to existing treatments like Papsimios?A: Chief Commercial Officer Steve Egge highlighted several advantages: INO-3107 does not require additional scoping and surgeries during the dosing window (unlike Papsimios, where 83% of patients required at least one MRD surgery), minimizing recovery days. It is not impacted by pre-existing neutralizing antibodies or an immunosuppressive papilloma microenvironment, and it does not require specialized ultra-cold chain handling, offering more flexibility in care settings. Q: What is the status of the FDA's pre-licensure inspections for INO-3107?A: Dr. Sumner reported that the FDA has completed all scheduled pre-licensure inspections, including clinical, drug manufacturing, in-house drug testing, and the delivery device facility. There was only one reported observation, which Inovio believes it has appropriately addressed and is in the process of submitting its response to the FDA. Q: What is the expected timeline for label negotiations and the PDUFA date for INO-3107?A: Dr. Sumner stated that Inovio anticipates starting label negotiations in September, and the company remains on track for the October 30, 2026 target PDUFA date. If approved, Inovio expects to receive seven years of orphan drug market exclusivity for INO-3107. Q: What were the key financial results for the second quarter of 2026?A: CFO Peter Kies reported that operating expenses dropped 19% year-over-year to $18.6 million in Q2 2026. The net loss was $6 million, or $0.07 per share, compared to a net loss of $23.5 million, or $0.61 per share, in Q2 2025. The decrease was primarily driven by a $13.9 million non-cash gain on fair value adjustment related to warrant liabilities. The company ended Q2 with $36.7 million in cash and short-term investments. Q: What is the company's cash runway and operational net cash burn estimate?A: CFO Peter Kies stated that with the addition of the July public offering (net proceeds of approximately $18.3 million), Inovio expects to extend its cash runway into late first quarter 2027 and through a potential launch of INO-3107. The projection includes an operational net cash burn estimate of approximately $18 million for the third quarter of 2026. Q: What progress has been made with the VGX-3100 partnership for Greater China?A: CEO Dr. Jackie Shea highlighted that partner Apollo Bio announced positive top-line results from its pivotal Phase 3 trial of VGX-3100 for cervical dysplasia. The trial met its primary efficacy endpoint of CIN2/CIN3 lesion regression and HPV16/18 viral clearance with a favorable safety profile. Apollo Bio plans to use these results to support a regulatory filing in China, further validating Inovio's DNA medicine platform for HPV-related diseases. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

U.S. Food and Drug Administration (FDA) review of Biologics License Application (BLA) for INO-3107 as a treatment for Recurrent Respiratory Papillomatosis (RRP) advancing with a target Prescription Drug User Fee Act (PDUFA) date of October 30, 2026 Commercial preparations advancing in anticipation of potential product launch for INO-3107 Positive topline results reported from Phase 3 trial for VGX-3100 for the treatment of cervical dysplasia patients by ApolloBio, INOVIO's partner in China Presented promising data from next-generation DNA-Encoded Monoclonal Antibody (DMAb™) and DNA-Encoded Protein (DPROT) programs at several scientific conferences Current cash, cash equivalents, and short-term investments anticipated to fund operations into late first quarter 2027, through a potential launch of INO-3107, if approved PLYMOUTH MEETING, Pa., Aug. 12, 2026 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced its financial results for the second quarter ended June 30, 2026 and provided an update on recent company developments. "As the FDA's review of our BLA for INO-3107 continues to advance, we are pleased to have held the informal clinical meeting with the FDA, where we presented the totality of data supporting INO-3107's safety and efficacy and highly differentiated approach in treating RRP, and our rationale for accelerated approval eligibility," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "We are confident in INO-3107's potential to become the preferred product among patients, healthcare providers and payers, if approved, and are committed to ensuring that all patients have access to therapeutic options that work for them in reducing the need for surgery to control their disease. We look forward to the final stages of the review process and further advancing our commercial preparations." Operational Highlights INO-3107 – Recurrent Respiratory Papillomatosis (RRP) The FDA's review of the BLA for INO-3107 continues to advance under the Agency's accelerated approval program toward a PDUFA target action date of October 30, 2026. Regulatory progress includes completion of the late-cycle review meeting and all scheduled pre-licensure inspections. An informal clinical meeting was conducted, where INOVIO presented the totality of data supporting INO-3107's safety and efficacy and highly differentiated approach in treating RRP, along with the company's rationale for accelerated approval eligibility. During the informal meeting, the FDA did not discuss its preliminary comment in the file acceptance letter regarding accelerated approval eligibility. In addition, the FDA stated that feedback on the confirmatory trial design would be forthcoming. INOVIO continues to believe that INO-3107 fulfills the criteria for accelerated approval by meeting an unmet clinical need and providing a meaningful therapeutic benefit over existing treatments. In anticipation of a potential approval in 2026, INOVIO is preparing its commercial launch activities. Recently, INOVIO engaged Syneos Health to recruit and deploy Medical Science Liaisons (MSLs), and Syneos Health is also serving as the company's contract sales organization to support commercialization in the U.S. INOVIO has also engaged or identified key commercial partners, including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient hub. The FDA previously granted INO-3107 both Orphan Drug and Breakthrough Therapy designations. VGX-3100 – Cervical Dysplasia (High-grade Squamous Intraepithelial Lesions) In May 2026, INOVIO's partner for VGX-3100 in Greater China, ApolloBio, announced positive topline results from its pivotal Phase 3 trial of VGX-3100 as a potential treatment for cervical dysplasia. The trial successfully met its predefined primary efficacy endpoint and demonstrated an overall favorable safety and tolerability profile. ApolloBio plans to use the results from the study to support a future filing for regulatory approval of VGX-3100 in China. VGX-3100 is INOVIO's investigational DNA immunotherapy developed for diseases associated with high-risk human papillomavirus (HPV) types 16 and 18. Next-Generation DNA Medicine Candidates INOVIO presented promising data from our next-generation DNA-Encoded Monoclonal Antibody (DMAb™) and DNA-Encoded Protein (DPROT) programs at the American Society of Gene and Cell Therapy Annual Meeting in May 2026 and the World Orphan Drug Congress in June 2026, highlighting positive preclinical data on Factor VIII production for Hemophilia A. INOVIO is continuing discussions with potential partners to accelerate development of this promising platform with a focus on developing additional DPROT indications in the rare disease space, including Fabry Disease and Hypophosphatasia (HPP). General Corporate INOVIO remains focused on financial discipline, directing resources to advance the INO-3107 program toward a potential 2026 approval and preparing for commercialization. The company strengthened its balance sheet with an underwritten public equity offering in July 2026. Net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $18.3 million. Second Quarter 2026 Financial Results Research and Development (R&D) Expenses: R&D expenses for the three months ended June 30, 2026 decreased to $10.8 million from $14.5 million for the same period in 2025. The decrease was primarily the result of lower employee and consultant compensation, including stock-based compensation, lower engineering outside services related to our device development, and lower inventory expenses, among other variances. General and Administrative (G&A) Expenses: G&A expenses decreased to $7.8 million for the three months ended June 30, 2026 from $8.6 million for the same period in 2025. Total Operating Expenses: Total operating expenses decreased to $18.6 million for the three months ended June 30, 2026 from $23.1 million for the same period in 2025. Net Loss: INOVIO's net loss for the three months ended June 30, 2026 was $6.0 million, or $0.07 per basic and diluted share, compared to a net loss of $23.5 million, or $0.61 per basic and diluted share, for the three months ended June 30, 2025. The decrease in net loss was primarily driven by a $13.9 million non-cash gain on fair value adjustment related to our warrant liabilities for the three months ended June 30, 2026. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss. Cash, Cash Equivalents and Short-term Investments: As of June 30, 2026, cash, cash equivalents and short-term investments were $36.7 million (excluding net proceeds from the July 2026 offering of approximately $18.3 million), compared to $58.5 million as of December 31, 2025. Cash Guidance INOVIO estimates that current cash, cash equivalents and short-term investments balances will support operations into late first quarter 2027, through a potential launch of INO-3107, if approved. This projection includes the net proceeds of approximately $18.3 million from the public offering in July 2026, as well as an operational net cash burn estimate of approximately $18 million for the third quarter of 2026. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake. Conference Call / Webcast Information INOVIO's management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO's financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO's website at http://ir.inovio.com/events-and-presentations/default.aspx. About INOVIO's DNA Medicines Platform INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms. About INOVIO INOVIO is a biotechnology company focused on developing and commercializing innovative DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com. Forward-Looking Statements This press release contains certain forward-looking statements relating to our business, including the timing and success of preclinical studies and clinical trials; the ability to obtain and maintain regulatory approval of our product candidates; the FDA's continued review of our BLA for INO-3107 toward a PDUFA target action date of October 30, 2026; the outcome of our meeting with the FDA to discuss eligibility for the accelerated approval program, including feedback on our proposed confirmatory trial design; the potential benefits of INO-3107 and our other potential product candidates, including our belief that INO-3107 has a positively differentiated product profile and the potential to become the preferred product by patients and their physicians, if approved; the scope, progress and expansion of developing and commercializing our product candidates, including the anticipated commercial launch of INO-3107, if approved; our anticipated growth strategies; our ability to establish and maintain development partnerships; our estimated operational net cash burn of approximately $18 million for the third quarter of 2026; and the expected sufficiency of our cash resources through a potential launch of INO-3107, if approved, and into late first quarter 2027. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law. Contacts Media: Jennie Willson, (267) 429-8567, [email protected] Investors: Peter Vozzo - ICR Healthcare, (443) 213-0505, [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/inovio-reports-second-quarter-2026-financial-results-and-recent-business-highlights-302849959.html

Results provide important clinical evidence to support ApolloBio's future regulatory submission in China of VGX-3100, INOVIO's DNA immunotherapy candidate ApolloBio's new clinical results further highlight the potential of INOVIO's DNA medicine platform to treat diseases caused by infection with various strains of the human papillomavirus (HPV), eliminating or reducing the need for surgical interventions PLYMOUTH MEETING, Pa., May 21, 2026 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that its partner for VGX-3100 in China, ApolloBio, announced positive topline results from its pivotal Phase 3 trial of VGX-3100, INOVIO's investigational DNA immunotherapy being developed as a potential treatment for cervical dysplasia. The trial successfully met its predefined primary efficacy endpoint and demonstrated an overall favorable safety and tolerability profile. ApolloBio plans to use the results from the study to support a future regulatory submission of VGX-3100 in China. "We believe these positive topline results for VGX-3100 reflect both the potential of our DNA medicine platform in HPV-related diseases and the power of partnerships to advance innovative DNA immunotherapies," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "We look forward to these data being presented at upcoming international medical conferences and published in peer-reviewed publications. We also anticipate future updates from ApolloBio as they work towards filing for potential regulatory approval of VGX-3100 in China." According to the terms of the ApolloBio Agreement, INOVIO is entitled to receive up to an aggregate of $20.0 million, less required income, withholding or other taxes, upon the achievement of specified milestones related to the regulatory approval of VGX-3100 in specified territories. In the event that VGX-3100 is approved for marketing, INOVIO will be entitled to receive royalty payments based on a tiered percentage of annual net sales. About VGX-3100VGX-3100 is an innovative therapeutic DNA vaccine developed for diseases associated with high-risk human papillomavirus (HPV) types 16 and 18. VGX-3100 is designed to elicit an antigen-specific, CD8+ T cell response to clear persistent HPV 16/18 infection, thereby promoting lesion regression and viral clearance. INOVIO licensed VGX-3100 to ApolloBio in 2018 for Greater China. ApolloBio's first intended indication for VGX-3100 is HPV-16/18-associated cervical dysplasia, with the aim of potentially providing patients in China with a non-surgical therapeutic option that may help avoid or reduce fertility-related risks associated with conventional surgical treatment (such as LEEP/conization), including preterm birth and miscarriage. ApolloBio is also advancing clinical development in other HPV-related high-grade precancerous lesions, including anal/perianal, vulvar, and vaginal disease. About ApolloBio's Phase 3 Trial with VGX-3100The study, sponsored by ApolloBio, is a multicenter, prospective, randomized, double-blind, placebo-controlled Phase 3 pivotal registrational clinical trial for the treatment of HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL), or cervical dysplasia. The primary endpoint was the composite response rate at Week 36, defined as histopathologic regression of cervical disease to low-grade lesion (CIN1) or normal histology, together with clearance of HPV-16 and/or HPV-18 infection. The study was led by Cancer Hospital, Chinese Academy of Medical Sciences, with Professor Lingying Wu serving as the leading principal investigator. A total of 22 top-tier tertiary hospitals across China participated in the trial. ApolloBio announced that the trial successfully met its predefined primary efficacy endpoint and demonstrated an overall favorable safety and tolerability profile, with no new significant safety risk signals observed. The positive outcome of this study provides important clinical evidence to support ApolloBio's future regulatory submission of VGX-3100 in China. About HPV, Cervical Cancer, and Cervical DysplasiaHPV is the most common sexually transmitted infection and is the main cause of cervical cancer, which is the fourth most common cancer in women globally with around 660,000 new cases and 350,000 deaths in 2022. Two types of HPV (HPV 16 and HPV 18) collectively cause about 70 percent of cervical cancer cases worldwide. High-grade cervical dysplasia is also caused by persistent HPV infection and is a precancerous condition that can progress to cervical cancer if left untreated. Currently there are no US-approved therapeutic treatments for persistent HPV infection or cervical dysplasia. About INOVIO's DNA Medicines PlatformINOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms. About INOVIOINOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, 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. About ApolloBioApolloBio Corp. is a leading Chinese biomedical company committed to research and development of innovative new medicines, accessing such new medicines through in-licensing, and additionally providing medical services. ApolloBio Corp. is focused on pharmaceutical products with significant market potential in China in the field of oncology; providing efficient access for American biomedical companies to enter into the Chinese market; and aiming to bring the newest and best medicines across the globe to the Chinese people. For more information, visit www.apollobio.com. Forward-Looking StatementsThis press release contains certain forward-looking statements relating to our business, including the potential of VGX-3100 for the treatment of cervical dysplasia, including the reproducibility of the clinical trial results in any future trials and the success of any future regulatory submission; the potential of INOVIO's DNA medicine platform in HPV-related diseases; our ability to establish and maintain development partnerships; and our expectations regarding future milestone or royalty payments. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law. INOVIO ContactsMedia: Jennie Willson, (267) 429-8567, [email protected]: Peter Vozzo - ICR Healthcare, (443) 213-0505, [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/positive-topline-results-from-a-phase-3-trial-for-vgx-3100-in-cervical-dysplasia-patients-announced-by-apollobio-inovios-partner-in-china-302779378.html

Biologics License Application (BLA) for INO-3107 actively being reviewed under the accelerated approval program by the U.S. Food and Drug Administration (FDA) with a target Prescription Drug User Fee Act (PDUFA) date of October 30, 2026 Commercial readiness plans continue to advance in anticipation of a potential commercial launch for INO-3107 as a treatment for adults with Recurrent Respiratory Papillomatosis (RRP) Clinical trial collaboration and supply agreement announced with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of glioblastoma (GBM) in a Dana-Farber Cancer Institute-sponsored trial Current cash, cash equivalents, and short-term investments anticipated to fund operations into first quarter 2027, beyond the target PDUFA date PLYMOUTH MEETING, Pa., May 13, 2026 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced its financial results for the first quarter ended March 31, 2026 and provided an update on recent company developments. "We remain focused on advancing INO-3107 toward its target PDUFA date to ensure that every RRP patient has access to therapeutic options that work for them to reduce the need for surgery. We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease, and that INO-3107 has the potential to become the preferred product by patients and their physicians, if approved, based on clinical results, tolerability data and the simplicity of its patient-centric treatment regimen that does not require additional surgeries during the dosing window," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "While the BLA for INO-3107 is under active review, we continue to advance our commercial readiness plans in anticipation of a 2026 approval, as well as leverage the power of partnerships to advance other promising candidates in our pipeline." Operational Highlights INO-3107 – Recurrent Respiratory Papillomatosis (RRP) INO-3107 is INOVIO's lead product candidate. It has been developed as a potential treatment for RRP, a rare and debilitating disease of the respiratory tract caused by infection with HPV-6 and/or HPV-11. In December 2025, the FDA accepted for review the company's BLA for INO-3107 under the accelerated approval program and set a target PDUFA date for October 30, 2026. Since then, the BLA has been under active review by the FDA, including the recent completion of the mid-cycle review meeting. INOVIO is focused on advancing INO-3107 through the regulatory process and working with the FDA as they complete their review of the BLA, including addressing the potential review issue they noted in their file acceptance letter regarding eligibility for review under the accelerated approval program. INOVIO continues to strongly believe that INO-3107 fulfills the criteria for accelerated approval by meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. As a part of communications about the mid-cycle review, the FDA has reiterated their intention to schedule the previously agreed to informal meeting to discuss their preliminary commentary on eligibility for review under the accelerated approval program. INOVIO continues to engage with the RRP community, including presenting data from our Phase 1/2 trial of INO-3107 at the Combined Otolaryngology Spring Meeting (COSM), the premier educational and technology forum for the specialists who treat RRP. INOVIO will also be presenting at the upcoming American Society of Clinical Oncology (ASCO) Annual Conference. In anticipation of a potential approval in 2026, INOVIO continues to advance commercial readiness plans, including incorporating key learnings from the launch of a competitor's recently approved RRP product. INOVIO believes INO-3107 has a positively differentiated product profile. INOVIO plans to commercialize INO-3107 itself in the U.S., with the support of a contract sales organization, and has engaged or identified key commercial partners, including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient HUB. INO-5412 In March 2026, INOVIO announced a clinical trial collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 (INO-5401 plus INO-9012 in a single vial) in combination with cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of glioblastoma (GBM). The combination therapy will be studied as a part of the INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute and conducted by Mass General Brigham Cancer Care Inc. This novel combination builds on INOVIO's previous promising research in GBM and could potentially benefit patients by providing additional checkpoint inhibition through CTLA-4 binding. Next-Generation DNA Medicine Candidates INOVIO presented promising data from our next-generation DNA-Encoded Monoclonal Antibody (DMAb™) and DNA-Encoded Protein (DPROT) programs at several recent scientific conferences. Based on positive preclinical data on Factor VIII production for Hemophilia A, INOVIO is developing additional DPROT indications in the rare disease space, including Fabry disease and Hypophosphatasia (HPP), and is in discussions with potential partners to accelerate development of this promising platform. General Corporate INOVIO remains focused on financial discipline, directing resources to advance the INO-3107 program toward a potential 2026 approval and preparing for commercialization. The company strengthened its balance sheet with an underwritten public equity offering in April 2026. Net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $16.0 million. First Quarter 2026 Financial Results Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2026 decreased to $14.1 million from $16.1 million for the same period in 2025. The decrease was primarily the result of lower employee and consultant compensation, including stock-based compensation, lower engineering outside services related to our device development, and lower expensed inventory, among other variances. General and Administrative (G&A) Expenses: G&A expenses decreased to $7.9 million for the three months ended March 31, 2026 from $9.0 million for the same period in 2025. Total Operating Expenses: Total operating expenses decreased to $21.9 million for the three months ended March 31, 2026 from $25.1 million for the same period in 2025. Net Loss: INOVIO's net loss for the three months ended March 31, 2026 was $19.7 million, or $0.28 per basic and diluted share, compared to a net loss of $19.7 million, or $0.51 per basic and diluted share, for the three months ended March 31, 2025. Cash, Cash Equivalents and Short-term Investments: As of March 31, 2026, cash, cash equivalents and short-term investments were $37.7 million (excluding net proceeds from the April 2026 offering of $16.0 million), compared to $58.5 million as of December 31, 2025. Cash Guidance INOVIO estimates that current cash, cash equivalents and short-term investments balances will support operations into the first quarter of 2027, beyond the target PDUFA date for INO-3107. This projection includes the net proceeds of $16.0 million from the public offering in April 2026, as well as an operational net cash burn estimate of approximately $18 million for the second quarter of 2026. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake. Conference Call / Webcast Information INOVIO's management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO's financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO's website at http://ir.inovio.com/events-and-presentations/default.aspx. About INOVIO's DNA Medicines Platform INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms. About INOVIO INOVIO is a biotechnology company focused on developing and commercializing innovative DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com. Forward-Looking Statements This press release contains certain forward-looking statements relating to our business, including the timing and success of preclinical studies and clinical trials; the ability to obtain and maintain regulatory approval of our product candidates; the FDA's acceptance of our BLA for INO-3107 with a PDUFA target action date set for October 30, 2026; a yet-to-be scheduled meeting with the FDA to discuss eligibility for the accelerated approval program; the potential benefits of INO-3107 and our other potential product candidates, including our belief that INO-3107 has a positively differentiated product profile and the potential to become the preferred product by patients and their physicians, if approved; the clinical collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of GBM in the INSIGhT trial; the scope, progress and expansion of developing and commercializing our product candidates, including the anticipated commercial launch of INO-3107, if approved; our anticipated growth strategies; our ability to establish and maintain development partnerships; our estimated operational net cash burn of approximately $18 million for the second quarter of 2026; and the expected sufficiency of our cash resources into the first quarter of 2027. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law. Contacts Media: Jennie Willson, (267) 429-8567, [email protected] Investors: Peter Vozzo - ICR Healthcare, (443) 213-0505, [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/inovio-reports-first-quarter-2026-financial-results-and-recent-business-highlights-302771410.html

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Inovio Pharmaceuticals Inc (NASDAQ:INO) is advancing its lead candidate, INO-3107, through the regulatory process with a target PDUFA date of October 30, 2026. The FDA completed a mid-cycle review of INO-3107 with no new significant issues raised, indicating positive progress in the approval process. Inovio Pharmaceuticals Inc (NASDAQ:INO) has strengthened its balance sheet with a public equity offering, extending its cash runway into the first quarter of 2027. The company is actively preparing for the commercial launch of INO-3107, including engaging commercial partners and completing product positioning work. Inovio Pharmaceuticals Inc (NASDAQ:INO) is leveraging partnerships to advance other promising candidates in its pipeline, including collaborations for glioblastoma treatment and next-generation DNA medicine platforms. The FDA has yet to schedule an informal meeting to discuss INO-3107's eligibility for accelerated approval, which could delay the approval process. Inovio Pharmaceuticals Inc (NASDAQ:INO) reported a net loss of $19.7 million for the first quarter of 2026, indicating ongoing financial challenges. The company's cash reserves decreased from $58.5 million at the end of 2025 to $37.7 million in the first quarter of 2026, highlighting financial strain. There is uncertainty regarding the impact of the FDA commissioner's resignation on the review timeline for INO-3107. Inovio Pharmaceuticals Inc (NASDAQ:INO) faces competition from existing products like the gorilla adenoviral-based immunotherapy, which may impact market penetration and acceptance of INO-3107. Warning! GuruFocus has detected 5 Warning Signs with INO. Is INO fairly valued? Test your thesis with our free DCF calculator. Q: Can you explain how you expect to launch and differentiate INO-3107 versus the currently marketed product? A: Steve Eggie, Chief Commercial Officer, explained that INO-3107 has a positively differentiated product profile in terms of efficacy, tolerability, and simplicity of the treatment regimen. The market opportunity is significant, with an estimated 14,000 to 27,000 RRP patients. They expect to be a fast-following second entrant, learning from the current market leader's successes and challenges. Q: What are the primary issues you intend to discuss in the informal meeting with the FDA? A: Dr. Mike Sumner, Chief Medical Officer, stated that the meeting will focus on confirming accelerated approval eligibility, emphasizing the significant safety advantage and differentiated mechanism of action of INO-3107, which allows treatment of patients that existing products cannot. Q: Can you talk about the key discussion points with the FDA regarding INO-3107 and any additional data submitted? A: Dr. Jackie Shea, President and CEO, mentioned that they submitted an assessment aid to the FDA, which included additional analysis but no new clinical data. The discussion will focus on why INO-3107 is eligible for accelerated approval, highlighting its meaningful therapeutic benefit over existing products. Q: When do you expect to receive feedback from the FDA on the confirmatory study design? A: Dr. Jackie Shea indicated that feedback on the confirmatory trial design is expected to be linked to the informal meeting with the FDA, as it is part of the review pathway. Q: How are your interactions with the RRP Foundation, and do you see an opportunity to utilize this patient advocacy group? A: Dr. Jackie Shea expressed that the RRP Foundation and community have been incredibly supportive. They are aligned in recognizing the unmet need for effective therapies for RRP patients and will continue to work closely with the foundation. Q: Do you expect the resignation of the current FDA commissioner to introduce uncertainty in the review timeline of INO-3107? A: Dr. Jackie Shea stated that they cannot comment on the inner workings of the FDA but continue to engage with the review team, and the review process seems to be proceeding as expected. Q: What would be your marketing strategy once INO-3107 gets approval? A: Dr. Jackie Shea explained that INO-3107 has a positively differentiated product profile and could become the product of choice for patients and physicians. They plan to incorporate learnings from the current market leader's launch into their go-to-market strategy. Q: How should we think about the potential label at approval, particularly the eligible patient population and anticipated restrictions? A: Dr. Jackie Shea expects a similar label to the approved product, as their patient population included a range of patients with different severities of disease, and there is no evidence that efficacy depends on disease severity or number of surgeries. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Inovio Pharmaceuticals (NASDAQ:INO) reported first-quarter financial results on Wednesday. The transcript from the company's first-quarter earnings call has been provided below. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. Access the full call at https://app.webinar.net/LJpjgyEg2Oa Inovio Pharmaceuticals Inc reported a net loss of $19.7 million for Q1 2026, with operating expenses dropping by 13% compared to the previous year. The company's lead candidate, INO 3107, is under active FDA review with an anticipated PDUFA date of October 30, 2026, and is being considered for accelerated approval. Inovio is advancing its commercial readiness plans for INO 3107, leveraging insights from the RRP community and preparing for a potential U.S. launch. The company is collaborating with Akizo Inc. to evaluate INO 5412 for glioblastoma treatment, and is advancing its next-gen DNA medicine platform, including DProt technology for rare diseases. Inovio strengthened its balance sheet with a $16 million public equity offering, projecting cash runway into Q1 2027, with a net cash burn of approximately $18 million for Q2 2026. OPERATOR Good afternoon ladies and gentlemen and welcome to the Inovio Pharmaceuticals Inc First Quarter 2026 Financial Results Conference Call. At this time all lines are in listen only mode. Following the presentation we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, May 13, 2026. I would now like to turn the conference over to Jenny Wilson. Please go ahead. Jenny Wilson (Moderator) Good afternoon and thank you for joining the INOVIO First Quarter 2026 Financial Results Conference Call. Joining me today on Today's call are Dr. Jackie Shea, President and Chief Executive Officer, Dr. Mike Sumner, Chief Medical Officer Steve Egy, Chief Commercial Officer and Peter Keys, Chief Financial Officer. Today's call will review our corporate and for the quarter ended March 31, 2026 as well as provide a general business update. Following prepared remarks we will conduct question and answer segment. During the call we will be making forward looking statements regarding future events and the future performance of the company. These statements relate to our business plans to develop Inovio Pharmaceuticals Inc's DNA Medicines platform, including the FDA's ongoing review of our BLA for INO 3107 including the October 30, 2026 PDUFA target date and our yet scheduled meeting with the FDA to discuss eligibility for the Accelerated Approval program. Our belief that INO 3107 fulfills the criteria for accelerated approval the potential benefits of INO3107, including our belief that it has a positively differentiated product profile and the potential to become the preferred product by patients and their physicians if approved the anticipated commercial launch of INO3107 if approved and our engagement of commercial partners in preparation for a potential launch our collaboration with Akizo Inc. To evaluate INO 5412 in combination with a novel dual checkpoint inhibitor for the potential treatment of gbm the advancement of our DPROT technology platform, capital resources, including our estimated operational net cash burn of approximately 18 million for the second quarter of 2026 and the expected sufficiency of our cash resources into first quarter of 2027 and our expectations regarding competition, market size and acceptance of INO 3107 if approved. All of these statements are based on the beliefs and expectations of management as of today. Actual events or results could differ materially. We refer you to the documents we file from time to time with the SEC which under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the Company. Verbally as well as statements made within this afternoon's press release. This call is being webcast live and a link can be found on our website ir.inovio.com and a replay will be made available shortly after this call is concluded. I will now turn the call over to Inovio Pharmaceuticals Inc's President and CEO, Dr. Jackie Shea. Dr. Jackie Shea Good afternoon and thank you to everyone for joining today's call. These are very busy times at Inovio as we remain focused on achieving our top priority advancing our lead candidate, INO3107 through the regulatory process and toward its October 30th target PDUFA date. Our goal is to ensure that every patient with recurrent respiratory papillomatosis or RRP, has access to a therapeutic option that can work for them to reduce the need for surgery if approved. We believe that our innovative therapy has the potential to become the preferred product Dr. Jackie Shea for patients suffering from rrp, a rare and debilitating disease of the respiratory tract with a critically high unmet need for effective non surgical treatment options. The BLA for 3107 has been in active review since December when the FDA accepted the file for review under the Accelerated Approval Program. While Mike will provide a more in depth regulatory update, I'd like to comment on a couple of key highlights. The FDA recently completed their standard mid cycle review with no new significant issues being raised and scheduled the late cycle Dr. Jackie Shea review for the third quarter. As you will recall from our last quarterly update, the FDA had previously agreed to an informal meeting to discuss the potential review issue they noted in their file acceptance letter regarding eligibility for review under the Accelerated Approval Program. As a part of communications about the mid cycle review, they reiterated their intent to schedule that meeting and we look forward to the discussion. While we make progress with 3107 on the regulatory front, we've been advancing our commercial readiness plans, including continuing to gather key strategic insights from the RRP community, and while the majority of our resources are focused on 3107, we're continuing to leverage the power of partnerships to advance other promising candidates in our pipeline, including an exciting opportunity to work with Akizo and the Dana Fabra Cancer Institute to build on our previous Immuno Oncology work in glioblastoma or gbm. We're also advancing our innovative next generation candidates and are pleased to have recently presented promising preclinical data on our DNA encoded protein or DProt technology work targeting factor 8 production in hemophilia A and announced two new rare disease targets in fabri disease and hypophosphatasia for the platform. Dr. Jackie Shea We are laser focused on these strategic priorities and excited about what's ahead for Inovio as we work to deliver on the promise of DNA medicine for patients. I'll now turn it over to Mike for some additional details on our regulatory progress with 3107. Mike Sumner (Chief Medical Officer) Mike thanks Jackie. As Jackie noted, since our BLA for INO 3107 was accepted for review under the Accelerated Approval Program In December of 2025, the FDA has been actively reviewing our submission. We have been responding to routine requests for information and meeting regular milestones in the review process, including the FDA completing its mid cycle review of our bla where no new significant issues were raised at the time of the mid cycle review. Mike Sumner (Chief Medical Officer) The FDA indicated that it is continuing to review the assessment aid we submitted in February which outlined our rationale for accelerated Approval program eligibility. They also reiterated their intent to schedule the previously agreed to informal meeting to discuss this potential review issue, which they noted in their file acceptance letter. In addition, we reported last quarter that we had submitted an updated protocol for our confirmatory trial to the ind, which is required under the Accelerated Approval Program. We are waiting for feedback from the agency on both the informal meeting and the confirmatory trial protocol so we can finalize the study design. We look forward to having the opportunity to discuss these issues further with the FDA and to emphasize why we believe that 3107 fulfills the criteria for accelerated approval by meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. I'd like to take a moment now to elaborate on that rationale. Based on published FDA guidance, our eligibility depends on the ability of 3107 to provide a meaningful therapeutic benefit over existing treatments and the ability to meet a remaining critical unmet need among patients. We believe that 3107 meets both of these criteria based on three factors. First, effectiveness as demonstrated in our phase 12 trial where the vast majority of patients experienced a 50 to 100% reduction in surgery in year one and with continued clinical improvement in year two. Second, an improved safety profile that does not include required surgery to maintain minimal residual disease during the dosing window and third, a differentiated mechanism of action that does not come with the risk of reduced clinical effectiveness due to known immune factors that impact the efficacy of the approved product, including pre existing neutralizing antibodies or an immunosuppressive tumour microenvironment, thus providing an important opportunity to treat patients who are not served by existing therapy. It is important to emphasize again that at the heart of our belief in 3107's eligibility for accelerated approval are the patients, patients who face the risk of permanent damage to the vocal cords and significant social, emotional and financial costs every time they require surgery to manage their disease. Every surgery matters to patients and we believe that every patient should have access to a treatment option that works for them to reduce the need for surgery. A compelling example of the remaining unmet need for therapeutic options for RRP patients is the fact that the recently approved Gorilla adenoviral based immunotherapy does not work for a number of patients, according to that product's published data. Further, the treatment regimen for this product requires surgery prior to the third and fourth doses if visible papilloma are present to maintain a state of minimal residual disease. This means that non responders or the patients for whom this product didn't work had two surgeries during the treatment window and then saw no clinical benefit or improvement in the following year, according to the published clinical trial data. That's why additional treatment options are so critical for the RRP community. There will continue to be patients not served by existing therapy. This need was highlighted in a recently published RRP foundation sponsored position statement where 16 leading RRP physicians outlined a contemporary evidence based approach to the management of RRP in adults. They highlighted the benefits of HPV specific immunotherapy to address the underlying disease that causes RRP and recommended HPV specific immunotherapy as the preferred first line therapy for adults, including the recently Approved immunotherapy and 3107 should it be approved. These are some of the key discussion points we've provided to the FDA and we look forward to having the opportunity to discuss them further. In the meantime, we will continue working collaboratively with the agency to advance our BLA through the regulatory process. I'll now turn it over to Steve for a commercial update. Steve thanks Mike. Steve Egy (Chief Commercial Officer) On the commercial front, we are continuing to advance our commercial readiness plans in anticipation of of a potential US approval in 2026 and we're planning to manage commercialization ourselves. With the support of a contract sales organization, we've completed targeting segmentation and product positioning work that supports a positively differentiated product profile. We've also engaged or identified key commercial partners including a third party logistics provider, specialty distributor, specialty pharmacy, patient hub and agency of record. In recent months we've also been watching and incorporating key learnings from the launch of our competitors recently approved product, noting where they seem to be having success or challenges in optimizing our own commercial plans accordingly. Importantly, there are key differences between the Gorilla adenoviral based product and 3107 and some of the challenges our competitor faced will not impact our launch, including the fact that we don't require an ultra cold chain and we don't require surgery to maintain minimum residual disease during the dosing window. We've also continued to gather important insights from the RRP community and recently attended the Combined Otolaryngology Spring Meeting, or cosm, a key conference for laryngologists. In conversations at that conference with physicians specializing in the treatment of rrp, we heard repeatedly that there continues to be a high unmet need for effective immunotherapy options that work for each patient. Both patients and doctors are highly motivated and very receptive to new treatments, which indicates that this market has significant unmet need and commercial opportunity, particularly for a potential product like 3107 that has a positively differentiated product profile across efficacy, tolerability and simplicity of the treatment regimen. I'll now turn it back to Jackie for a pipeline update. Dr. Jackie Shea Jackie thanks Steve. With our resources focused primarily on 3107, partnerships will continue to be a key part of our strategy to advance other promising candidates in our pipeline. In March this year, we announced an innovative collaboration with Akizo to evaluate INO 5412 in combination with their novel dual checkpoint inhibitor as a potential treatment for glioblastoma, the most common and aggressive form of brain cancer. The study, which builds on our previous promising research in gbm, will be part of a Phase two adaptive platform trial sponsored by the Dana Farber Cancer Institute. We've also continued to advance our exciting next generation DNA medicine platform and shared research on our DNA encoded protein or DProt technology targeting factor 8 at several key conferences including the World Federation of Haemophilia Global Conference and the American Society of Gene and Cell Therapy Annual Meeting. Building on the promising DNA encoded monoclonal antibody research published in Nature Medicine last year, DProt Technology aims to enable long term protein expression within the body and address the shortcomings of conventional therapeutic protein or enzyme replacement therapies based on positive preclinical data on factor VIII production for haemophilia A. Inovio is developing additional DPROD indications in the rare disease space, including Fabry Disease and hypophosphatasia, and is in discussions with potential partners to accelerate development of this promising platform. Now I'll turn it over to our CFO Peter Keyes for a financial update. Peter? Peter Keyes (Chief Financial Officer) Thanks, Jackie. Today I'd like to provide an overview of Inovio Pharmaceuticals Inc's financial results for the first quarter of 2026. As Jackie noted, our primary goal is to advance INO 3107 towards approval and we remain focused on optimizing resources to support that program. I am pleased to report that the company strengthened its balance sheet with an underwritten public equity offering in April 2026. Net proceeds from the offering, after deducting underwriter discounts, commissions and offering expenses, were approximately 16 million. We finished the first quarter of 2026 with 37.7 million in cash, cash equivalents and short term investments compared to 58.5 million as of December 31, 2025. With the addition of the April public offering, we have extended our estimated cash runway into the first quarter of 2027 beyond the target PDUFA date of INO 3107. This projection includes an operational net cash burn estimate of approximately 18 million for the second quarter of 2026. These. These cash runway projections cash Runway projections do not include any further capital raise activities that we may undertake and are based on current projections and assumptions. Turning our results to the first quarter, operating expenses dropped from 25.1 million in the first quarter of 2025 to 21.9 million in the first quarter of 2026, a 13% decrease. Inovio's net loss for the first quarter of 2026 was 19.7 million, or $0.28 per share, basic and dilutive, compared to a net loss of 19.7 million, or $0.51 per share, basic dilutive for the first quarter of 2025. As a reminder, you can find our full financial statements in this afternoon's press release as well as in our quarterly report on Form 10Q filed with the SEC. And with that, I'll turn it back over to Jackie. Dr. Jackie Shea Thanks, Peter. I'd now like to pause to open up the call to answer any questions you might have. Operator. OPERATOR Thank you, ladies and gentlemen. We will now begin the question and answer session. Should you have a question, please press the star followed by the one. On your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Ted with Piper Sandler. Please go ahead. Ted Great. Thank you very much for taking the question. I really appreciate it and it sounds like things are going well with the review. I saw the Pepcinios numbers of 22, 21.6, which looks pretty good. Any comments? Can you expand a little more about how you expect to launch and differentiate versus the currently marketed product? Steve Egy (Chief Commercial Officer) Nice to hear from you Steve. Do you want to take that one? Sure. He TED yeah, so we saw the prestige performance as well and kind of how we're thinking about the market and how we'll compete is, you know, we have, we think a positively differentiated product profile when we look across efficacy, tolerability and the simplicity of the treatment regimen. So we think we can be well differentiated in the market. And then, you know, the overall market opportunity itself, you know, there's a very significant number of patients. 14,000 RRP patients is the most kind of recently published number, although that's quite dated. And our own estimate of claims data, you know, demonstrates that that's probably a significant underestimate. I think Precigen has noted 27,000 RRP patients. So by the time we get to market, we expect, you know, Precigen or Papzimius would have had single digit penetration into the market in the first year or so. The vast majority of the opportunity will remain by the time we get to market and we do expect to be a fast following second entrant and there's many examples of second entrants, you know, fast following that do very, very well in the market and in some cases take, take market leadership. Dr. Jackie Shea And if I can just add here, Steve, I think, you know, the Papsimius launch also gives us the opportunity to learn from their successes and challenges and we'll certainly be baking those learnings into our go market plans as well. So I think, you know, the progress that we see Precigen making in the marketplace is really an indication of the high met need for these patients for therapeutic alternatives to surgery. And we're really excited by the opportunity for 3107. Mike Sumner (Chief Medical Officer) Very great. And then if I may, just a quick follow up when it comes to this informal meeting with fda, what are the primary issues that you intend to discuss there? Mike yeah, active. So I mean, I mean this is really about confirming our accelerated approval eligibility. I think it's, I don't think we'll have much discussion around the clinical unmet need. That's very, it's very obvious, I think to everybody concerned. So it's really around the discussion of meaningful therapeutic benefit. And as we've stated, we firmly believe we have a significant safety advantage without the requirement for those Minimal residual disease surgeries and a differentiated mechanism of action will enable us to treat patients that the existing product won't be able to. Great, that's really helpful and I appreciate how you laid it out in the call earlier. Thanks very much. Jay Thank you. Your next question comes from Jay with Oppenheimer. Please go ahead. Oh, hey, thanks for providing this update and taking the questions. Can you just maybe talk about some of the key discussion points with the FDA when you meet on 3107 and remind us any additional data or evidence that, that you have submitted or will submit. And then I had a follow up, if I could, please. Dr. Jackie Shea Yeah, sure. So nice to hear from you, Jay. So I'll start off and then I'll ask Mike to chip in here. So if you remember, we submitted our assessment aid to FDA back in February ahead of the informal meeting and that was in direct response to a request from the agency. And that assessment aid doesn't include any new clinical data, but it did include additional analysis of the data that we performed. So at the upcoming meeting, as Mike indicated, what we principally expect to be discussing with the agency are the arguments that we've laid out in the BLA and also in the assessment aid as to why we believe 3107 is eligible for review under the accelerated approval pathway. And that's really around providing meaningful therapeutic benefit over the existing product and that 3107 has the potential to meet this unmet need. Mike, do you want to go into some more specifics? Mike Sumner (Chief Medical Officer) I mean, I certainly can. I mean in terms of the differentiated mechanism of action which should enable us to treat different patient population than Papzimius. We've talked previously about the presence of neutralizing antibodies to the gorilla adenoviral platform that will decrease the immune response that those patients will see with with Papzimius. And we've also talked about their the requirement that they have for performing those minimal residual disease surgeries is based on the immunosuppressive papilloma microenvironment that they utilize those surger overcome. We have shown with our data that was published in Nature Communications that the elements that Presagen identified did not impact the efficacy of INO 3107. So we believe there's a meaningful therapeutic difference of the two products. And I think also when you look at the two different platforms, we've talked about DNA medicines having the capability of redosing and continuing, continuing to generate that T cell response. RRP is a chronic viral illness and we believe redosing is going to be an important part of the treatment regimen to ensure these patients can hopefully become surgery free long term. Jay Great, that's super helpful, thank you. And if I could just ask one follow up, could you please talk about when you expect to receive feedback from the FDA on the confirmatory study design and what sort of feedback you expect to receive from the fda? Mike Sumner (Chief Medical Officer) Yeah, great question, Jay. I mean we expect as the confirmatory trial design is really linked to the review pathway and the requirement to conduct that confirmatory trial, we would expect that feedback to be linked to the informal meeting. So I think as part of the informal meeting and discussion of the review pathway, we would hope to learn when we'll get feedback on that confirmatory trial design. Jay Okay, great. We'll look forward to that. Thanks for taking the questions. Mike Sumner (Chief Medical Officer) My pleasure. Sudan Thank you. Your next question comes from Sudan with Stevens. Please go ahead. Thanks. Hi everyone, thank you for the updates and great to hear all the progress to piggyback off the confirmed free trial question that was just asked. You know, since there's still a high unmet medical need for rrp, you know, despite the Pap symbios being on the market, can you let us know to what capacity you're still treating old or new patients with 3107? And secondly, will you get any longer term durability of Response data from 3,107 this year since if I remember correctly, 3,107 shined on the previous long term analysis readout? Mike Sumner (Chief Medical Officer) Yeah, thanks Sudan for the question. Our original Phase 12 trial incorporated the initial four dose regimen and then the follow up data was actually just a retrospective look back on the same patient population with no additional dosing. So we at present we do not have any planned readout of data on 3107 with continued dosing. We have previously talked about data that we have for INO 3100, which has shown the ability to continue generate a T cell response six to nine months after the completion of the initial treatment. So we are excited to discuss with the agency what a redosing strategy will look like following approval of 3,107 if it gets approved. Sudan Great. And secondly, just wanted to ask also, how have your interactions with the RRP foundation been recently as you near your PDUFA data admits? Also the papcemios launch currently happening, do you feel like you have an opportunity here to further utilize this patient advocacy group as a resource to specifically reach the community setting that Papademios I think currently has only penetrated about 25% to date? Dr. Jackie Shea Yeah, that's a great question. Sudan. And I'm very pleased to say that the RRPF foundation and the RRP community have been incredibly supportive and we've, you know, we're very much aligned with them. We recognize that the current approved therapy doesn't work for all RRP patients and every RRP patient deserves a therapy that works for them. Every surgery matters to RRP patients. And so our goals are very much aligned with the foundations. We continue to work very closely with them and we're very grateful for their support and we'll obviously continue to work with them going forward. But yes, understanding the patient perspective and the remaining unmet need is absolutely critical to what we're trying to do with 3,107. Sudan Saddam. Any follow ups? All good. Thank you so much. I appreciate the details. Ying Thank you. Your next question comes from Ying with H.C. wainwright. Please go ahead. Yanzi Thank you for taking my question. This is Yanzi sitting in for Yi Chen. I have two questions. The first is, with respect to the fda, do you expect the resignation of the current FDA commissioner to introduce any sort of uncertainty in the review timeline of ino3107? Dr. Jackie Shea Yep. I don't think we can really comment on the inner workings of the FDA at the moment, but what I can say is, you know, we continue to engage with our review team and respond to information requests and the review seems to be proceeding. As we commented around the mid cycle review, they did reiterate that they're still reviewing the assessment aid and that they plan to schedule the informal meeting and we encourage them to, we continue to encourage them to schedule that meeting. We're keen to discuss it with them. So I think, you know, where we are at the moment is really just continuing to progress the review and we're very keen to have that discussion. Yanzi Thank you. And my second question is about when INO 3107 gets approval. So once that happens, what would be your marketing strategy or approach to seize market shares from Bev Zumios? Dr. Jackie Shea Yeah, so we believe, as Steve I think has outlined, we believe that 3107 has a positively differentiated product profile and could become the product of choice for patients and RRP physicians. And this is really based on our clinical effectiveness, our tolerability and a simple patient centric approach to treatment with 3107. So clearly we've been learning from the Papcemius launch. We'll be incorporating key learnings from their launch into our go to market plan and we're planning to be a part follower as Steve also outlined, we're expecting the vast majority of the prevalent pool or the available market to still be available when we come to market if approved. And there are also new patients being diagnosed every year. So we think we're in a good position to be able to compete with the approved product. Steve, anything you want to add? No, I think that's good. Yi Chen Yi Chen, any follow up? Oh, thank you. Your last question comes from Liang Chen with Jeffries. Please go ahead. Liang Cheng Hey, this is Liang Cheng for Rajaston. Thank you for taking our questions, I guess, from us. How. How should we think about the potential label at approval, particularly the eligible patient population and anticipated restrictions versus the Phase 12 population? Dr. Jackie Shea Nice to hear from you, and it's a great question. So we would expect to have a very similar label to the approved products, and that's based on the fact that we recruited patients who had had between two to eight surgeries in the prior year. In our patient population, we had a good balance of patients who were infected with HPV 6 and 11, and even a combination of them both. And we have no evidence from our mechanism of action that efficacy would depend on severity of disease or number of surgeries in the prior year. So we would expect a very similar label with. With no restrictions. Okay, got it. Liang Cheng And at a higher level, how are you thinking about pricing relative to precision? Dr. Jackie Shea Yeah, so we're thinking of rare disease pricing. Clearly, in our peer research that we've conducted, pears recognize that rare disease pricing is appropriate for this indication. We'll be conducting some price optimization research. And. And we'll be commenting on pricing a bit closer to launch. Got it. Thank you. OPERATOR Thank you. There are no further questions at this time. I will turn the call back over to Jackie Shea. Dr. Jackie Shea Thank you. As we've outlined here today, Anovio is intent on meeting the milestones ahead for INO 3107 and the other promising candidates in our pipeline. We're motivated by the potential opportunity to deliver on the promise of DNA medicine for RRP patients and grateful for the support from the RRP foundation and larger RRP community. They have waited so long for relief from the devastating impact of their disease. We believe every patient deserves access to a treatment option that works for them. Because every patient matters and every surgery matters. We're working every day to help make that vision a reality. Thank you for your attention and good evening, everyone. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. This article Full Transcript: Inovio Pharmaceuticals Q1 2026 Earnings Call originally appeared on Benzinga.com ﾩ 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is prioritizing the regulatory advancement of INO-3107 for Recurrent Respiratory Papillomatosis (RRP), targeting an October 30, 2026, PDUFA date. The FDA completed a mid-cycle review with no new significant issues raised, though the agency is still evaluating the company's rationale for accelerated approval eligibility. Management attributes the potential for INO-3107 to become the preferred treatment to its differentiated profile, specifically its lack of ultra-cold chain requirements and the absence of mandatory surgeries during the dosing window. The company is leveraging a partnership-heavy strategy for its broader pipeline, including a Phase II collaboration with Akeso and Dana-Farber in glioblastoma, to preserve resources for the lead program. Operational focus has shifted toward commercial readiness, including the identification of third-party logistics and specialty pharmacy partners to support a potential 2026 launch. Preclinical expansion of the DPROT technology platform into Fabry disease and hypophosphatasia is intended to address limitations of conventional protein replacement therapies. Cash runway is projected to extend into the first quarter of 2027, supported by an April 2026 equity offering and an estimated Q2 2026 net cash burn of $18 million. The company anticipates an informal meeting with the FDA to resolve potential review issues regarding accelerated approval eligibility and to finalize the confirmatory trial protocol. Commercial strategy assumes a 'fast follower' position, aiming to capture market share from the first-to-market competitor by targeting the vast majority of the 14,000 to 27,000 RRP patients who remain untreated. Management expects a potential label for INO-3107 to be broad, covering both HPV-6 and HPV-11 strains without restrictions based on disease severity or prior surgery frequency. Eligibility for accelerated approval remains a potential review issue, contingent on proving 'meaningful therapeutic benefit' over the recently approved competitor product. The company completed an underwritten public equity offering in April 2026, generating approximately $16 million in net proceeds to bolster the balance sheet. Operating expenses decreased by 13% year-over-year to $21.9 million, reflecting ongoing resource optimization and a narrowed focus on the lead clinical program. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management believes INO-3107 is positively differentiated by its tolerability and simplicity, noting that the competitor's product requires surgery to maintain minimal residual disease during dosing. The company expects the competitor to achieve only single-digit market penetration in its first year, leaving the vast majority of the prevalent patient pool available for INO-3107. The primary argument rests on a differentiated mechanism of action that avoids neutralizing antibodies and the immunosuppressive microenvironment issues seen with adenoviral platforms. Management emphasized that DNA medicines allow for redosing, which is critical for treating RRP as a chronic viral illness. Inovio intends to utilize rare disease pricing, noting that preliminary payer research indicates such pricing is considered appropriate for the RRP indication. Specific price optimization research is ongoing, with more details expected closer to the potential launch date.