"This latest regulatory achievement further validates our efforts to bring INO-3107 to RRP patients around the world and shows that our cross functional development team is meeting the highest of standards in pursuit of that goal," said Cheryl Elder, INOVIO's Senior Vice President of Regulatory Affairs. "We're pleased to receive confirmation that our development efforts in Europe continue to make progress." INO-3107 is designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 prot ...

Core Viewpoint - Inovio's lead DNA medicine candidate, INO-3107, has received the Innovation Passport designation under the UK's Innovative Licensing and Access Pathway (ILAP), which is expected to enhance its potential to transform treatment for recurrent respiratory papillomatosis (RRP) patients [2][13]. Company Developments - Inovio plans to initiate a confirmatory study of INO-3107 for RRP before submitting the Biologics License Application (BLA) to the FDA, with submission expected in the second half of 2024 [3][21]. - The company has completed a phase I/II study for INO-3107, which met its efficacy endpoint, indicating promising results for the treatment of HPV-related RRP [9][20]. - If approved, INO-3107 could be the first DNA medicine available for RRP patients in the United States and Inovio's first approved product [10]. Clinical Pipeline - Inovio's clinical pipeline includes several other DNA medicine candidates targeting various cancers and infectious diseases, indicating a diverse development strategy [4]. Market Performance - Year to date, Inovio's shares have surged by 80.3%, significantly outperforming the industry average rise of 5.1% [8]. - The Zacks Consensus Estimate for Inovio's 2024 earnings per share has not changed, remaining at 5 cents, while the 2025 loss per share estimate is pegged at 11 cents [5]. Regulatory Pathway - The Innovation Passport designation provides a streamlined process for regulatory approval, including a potential 150-day accelerated marketing authorization application assessment and continuous benefit-risk assessment [7]. - Inovio plans to engage with ILAP partners to determine the regulatory pathway for INO-3107's approval in the UK [15].

Inovio Pharmaceuticals (INO) shares rallied 19% in the last trading session to close at $11.04. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 2.1% loss over the past four weeks. Earnings and revenue growth expectations certainly give a good sense of the potential strength in a stock, but empirical research shows that trends in earnings estimate revisions are strongly correlated with near-term stock price mo ...

"The U.K. Innovation Passport designation is yet another recognition of the promise of INO-3107 to potentially transform the treatment paradigm for RRP patients," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "We are honored to receive this designation, which offers us enhanced access to regulators and development tools that could accelerate the timeline for achieving U.K. regulatory approval of INO-3107. We look forward to continuing our discussions with the ILAP partners as we ...

This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and expectations regarding our research and development programs, including the planned submission of a BLA in the second half of 2024 and the planned commercial launch of INO-3107 if regulatory approval is obtained. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent ...

The stock option has an exercise price of $8.08, which is equal to the closing price of INOVIO's common stock on June 28, 2024. The stock option will vest and become exercisable with respect to one-fourth of the shares underlying the stock option on the Grant Date, and an additional one-fourth of the shares underlying the stock option on the first, second, and third anniversaries of the Grant Date. The vesting of the stock option will be subject to the employee's continued employment with INOVIO on the appl ...

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PLYMOUTH MEETING, Pa., June 4, 2024 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, today announced that INOVIO's President and CEO, Dr. Jacqueline Shea, and Chief Medical Officer, Dr. Michael Sumner will participate in a virtual fireside chat hosted by Sudan Loganathan, Ph.D., Managing Director and equity research analyst at Stephens, Inc. The f ...

INOVIO 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. Contacts Media: Jennie Willson, (267) 429-8567, [email protected] Investors: Thomas Hong, (267) 440-4298, [email protected] SOURCE INOV ...

Financial Data and Key Metrics Changes - INOVIO reported a net loss of $30.5 million for Q1 2024, or $1.31 per share, compared to a net loss of $40.6 million, or $1.89 per share, for Q1 2023, indicating an improvement in financial performance [51] - Total operating expenses decreased from $44.1 million in Q1 2023 to $31.5 million in Q1 2024, a 29% reduction [44] - Cash, cash equivalents, and short-term investments increased to $105.6 million as of March 31, 2024, compared to $45.3 million at the end of 2023 [51] Business Line Data and Key Metrics Changes - R&D expenses for Q1 2024 totaled $20.9 million, down from $30.2 million in Q1 2023, reflecting reduced drug manufacturing and clinical trial costs [44][50] - G&A expenses decreased to $10.6 million in Q1 2024 from $13.9 million in Q1 2023, primarily due to lower employee compensation and legal expenses [45] Market Data and Key Metrics Changes - INOVIO is preparing for the potential approval and commercialization of INO-3107 for recurrent respiratory papillomatosis (RRP), with plans to file a Biologics License Application (BLA) in the second half of 2024 [9][10] - The company is also advancing INO-3112 for throat cancer and INO-4201 as an Ebola vaccine booster, indicating a diversified pipeline targeting significant unmet medical needs [11][32] Company Strategy and Development Direction - INOVIO's strategic focus includes the potential approval of INO-3107, advancing other promising candidates, and strengthening the overall business [8][9] - The company aims to establish key relationships and build a successful commercial launch strategy for INO-3107, which could be the first FDA-approved therapy for RRP [10][35] - INOVIO plans to conduct a placebo-controlled confirmatory trial for INO-3107, which aligns with feedback from both U.S. and European regulators [28][94] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the alignment with the FDA regarding the trial design for INO-3107 and the potential to initiate the trial soon [9][13] - The company remains committed to financial discipline and operational excellence, with a cash runway projected to extend into Q3 2025 [46] - Management acknowledged the impact of HPV vaccination rates on RRP incidence, noting that despite progress, a significant portion of the population remains unvaccinated [55][56] Other Important Information - INOVIO raised approximately $33 million through a common stock offering in April 2024, which will support commercialization efforts and pipeline progress [12][49] - The company is utilizing its proprietary CELLECTRA device for the delivery of DNA medicines, which has been well-received by both patients and healthcare providers [23][76] Q&A Session Summary Question: Impact of HPV vaccines on RRP rates - Management noted that while HPV vaccines have reduced pediatric RRP rates in countries with high vaccination rates, vaccination levels have stalled in many high-income countries, leaving a significant population unprotected [55][56] Question: Expected operational expenditure burn with Phase 3 trial for INO-3112 - Management indicated an increase in operational burn due to advancing commercial activities and the upcoming Phase 3 trial, with guidance suggesting cash runway into Q3 2025 [59] Question: Device aspects of the BLA for INO-3107 - Management confirmed that INO-3107 is regulated as a combination product, requiring submission for both the drug and device components, with significant experience from previous studies [62][64] Question: Enrollment timeline for the confirmatory trial - Management targeted approximately 100 patients for the confirmatory trial, expecting a similar recruitment period as the Phase 1/2 study, which was completed in less than a year [67][68] Question: Competitive landscape regarding administration routes - Management emphasized that the CELLECTRA device is well-tolerated and not seen as a barrier compared to subcutaneous administration, with positive feedback from physicians [76][77] Question: Sample size and powering assumptions for the confirmatory trial - Management confirmed a two-to-one randomization for the trial, aiming to limit the number of patients not receiving active treatment, with confidence in the effect size based on previous study data [91][92]