Clinical Trials and Regulatory Updates - INO-3107 BLA submission delayed to mid-2025 due to manufacturing issues with the single-use disposable administration component of the CELLECTRA® device[2][3] - INO-3107 designated as an innovative medicine under the U.K.'s Innovative Licensing and Access Pathway (ILAP) and received Advanced Therapy Medicinal Product (ATMP) Certification from the European Medicines Agency[3] - INO-3112 Phase 3 trial design submitted to European regulatory authorities, with plans to investigate INO-3112 in combination with LOQTORZI for oropharyngeal squamous cell carcinoma (OPSCC)[4] - INO-4201 Phase 2/3 clinical trial protocol for Ebola booster expected to be submitted to the FDA in Q3 2024[5] Financial Performance and Cash Position - Cash, cash equivalents, and short-term investments totaled $110.4 million as of June 30, 2024, compared to $145.3 million as of December 31, 2023[7] - R&D expenses for Q2 2024 were $23.1 million, a slight decrease from $23.7 million in Q2 2023[7] - G&A expenses for Q2 2024 were $10.2 million, down from $13.5 million in Q2 2023[7] - Net loss for Q2 2024 was $32.2 million, or $1.19 per share, compared to a net loss of $35.5 million, or $1.61 per share, in Q2 2023[7] - INOVIO estimates its cash runway to extend into Q3 2025, with an operational net cash burn estimate of approximately $28 million for Q3 2024[9] - Cash and cash equivalents increased to $34,392,404 as of June 30, 2024, compared to $14,310,862 as of December 31, 2023[14] - Short-term investments decreased to $76,029,116 as of June 30, 2024, from $130,982,913 as of December 31, 2023[14] - Total current assets decreased to $117,561,045 as of June 30, 2024, from $153,113,100 as of December 31, 2023[14] - Total liabilities decreased to $37,057,996 as of June 30, 2024, from $53,602,294 as of December 31, 2023[14] - Revenue from collaborative arrangements and other contracts for the six months ended June 30, 2024, was $100,762, compared to $340,914 for the same period in 2023[15] - Research and development expenses for the six months ended June 30, 2024, were $44,001,307, compared to $53,920,481 for the same period in 2023[15] - General and administrative expenses for the six months ended June 30, 2024, were $20,781,337, compared to $27,413,708 for the same period in 2023[15] - Net loss for the six months ended June 30, 2024, was $(62,706,969), compared to $(76,183,850) for the same period in 2023[15] - Basic and diluted net loss per share for the six months ended June 30, 2024, was $(2.48), compared to $(3.50) for the same period in 2023[15] - Weighted average number of common shares used to compute net loss per share for the six months ended June 30, 2024, was 25,244,657, compared to 21,784,343 for the same period in 2023[15] Leadership and Organizational Updates - Steve Egge appointed as Chief Commercial Officer to lead commercial strategy and operations, bringing extensive experience in HPV, immunology, and rare diseases[6]

PLYMOUTH MEETING, Pa., Aug. 8, 2024 /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 of 2024 and provided an update on recent company developments. "We continue to make progress with our lead candidate, INO-3107, which has the potential to significantly improve the lives of patients with R ...

"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 ...

Core Insights - INOVIO's lead DNA medicine candidate, INO-3107, has received the U.K. Innovation Passport designation, which recognizes its potential to transform treatment for Recurrent Respiratory Papillomatosis (RRP) patients [1][7] - The Innovation Passport is part of the Innovative Licensing and Access Pathway (ILAP) aimed at accelerating market access and regulatory approval for promising medicines in the U.K. [2][7] - INO-3107 is designed to elicit a T cell response against HPV-6 and HPV-11, potentially reducing the need for surgical interventions in RRP patients [2][8] Company Overview - INOVIO is a biotechnology company focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases [12] - The company utilizes proprietary technology to design DNA plasmids and deliver them using its investigational device, CELLECTRA® [11][12] Product Details - INO-3107 has shown promising results in a Phase 1/2 clinical trial, with 81.3% of patients experiencing a decrease in surgical interventions after treatment [2][9] - The treatment generated a strong immune response, with activated CD4 and CD8 T cells observed, indicating a persistent cellular memory response [2][8] - INO-3107 was well tolerated, with mostly low-grade adverse effects reported [2][8] Regulatory Context - The ILAP, launched by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in 2021, aims to facilitate the development and access to innovative medicines [2][7] - Benefits of the ILAP include a potential 150-day accelerated assessment for Marketing Authorization Applications (MAA) and continuous benefit-risk assessments [2][7] Market Potential - RRP is a rare disease caused by HPV-6 and HPV-11, characterized by the growth of papillomas in the respiratory tract, which can lead to severe complications [10] - Market research indicates that even a reduction of one surgery is significant for patients, as each surgery carries risks of permanent damage [10]

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 ...