PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced its financial results for the second quarter of 2024 and provided an update on recent company developments. The company highlighted progress on its lead candidate, INO-3107, and other key projects.
“We continue to make progress with our lead candidate, INO-3107, which has the potential to significantly improve the lives of patients with RRP. We expect all non-device related elements of our BLA package to be completed by year end and our pre-BLA meeting last week with the FDA provided us with confidence that we remain on the right track for the regulatory submission. However, as part of the testing process required for BLA submission, we’ve recently identified a manufacturing issue with the single use disposable administration component of our device that we believe is resolvable, but will take additional time to rectify,” said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer.
INO-3107 is being developed to treat recurrent respiratory papillomatosis (RRP). INOVIO plans to submit its Biologics License Application (BLA) to the FDA in mid-2025 after resolving a manufacturing issue with the single-use disposable component of its CELLECTRA® device. Despite this setback, INOVIO remains positive about INO-3107’s potential to be the first DNA medicine approved in the U.S.
Dr. Shea added, “We will continue to work hard to advance all other elements necessary for INO-3107’s success, including working to initiate our confirmatory trial, advancing plans for our redosing trial, making key regulatory progress in Europe and the U.K., and continuing commercial preparations to be launch-ready if we receive approval.”
Beyond INO-3107, INOVIO is making strides with other projects. The company submitted Phase 3 clinical plans for INO-3112 to European regulatory authorities. INO-3112 aims to treat oropharyngeal squamous cell carcinoma (OPSCC) in combination with LOQTORZI. The Phase 3 trial will be conducted in Europe and North America, pending resolution of the manufacturing issue affecting the CELLECTRA® device.
For its Ebola booster vaccine candidate, INO-4201, INOVIO plans to resubmit Phase 2 clinical trial protocols to the FDA in the third quarter. Previous trials showed INO-4201 boosted immune responses in 100% of participants after an initial dose of Ervebo.
INOVIO also welcomed Steve Egge as Chief Commercial Officer. Egge brings extensive experience in launching products in immunology, vaccines, and rare diseases. His expertise is expected to be invaluable as INOVIO prepares for the potential launch of INO-3107 and other candidates.
Recent Business Highlights
INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
- INOVIO is preparing for its BLA submission, advancing development of BLA modules, trial site preparations, and commercial readiness plans.
- Identified a manufacturing issue with the CELLECTRA® device’s disposable component, delaying the BLA submission to mid-2025.
- Achieved “Innovation Passport” designation under the U.K.’s Innovative Licensing and Access Pathway (ILAP).
- Received Advanced Therapy Medicinal Product (ATMP) Certification from the European Medicines Agency’s Committee for Advanced Therapies (CAT).
INO-3112 – Oropharyngeal Squamous Cell Carcinoma (OPSCC)
- Submitted Phase 3 trial design to European regulatory authorities.
- Plans to investigate INO-3112 in combination with LOQTORZI.
- Received positive feedback from the FDA on the study protocol.
INO-4201 for Ebola
- Plans to resubmit Phase 2/3 clinical trial protocols to the FDA in the third quarter.
- Previous trials showed INO-4201 boosted immune responses in 100% of participants.
Operational and Financial Updates
- Appointed Steve Egge as Chief Commercial Officer.
- Strengthened balance sheet with a $33.2 million offering of common stock and pre-funded warrants in April 2024.
Second Quarter 2024 Financial Results
- Cash, Cash Equivalents, and Short-term Investments: $110.4 million as of June 30, 2024, compared to $145.3 million as of December 31, 2023.
- Research and Development (R&D) Expenses: $23.1 million for Q2 2024, slightly lower than $23.7 million for Q2 2023.
- General and Administrative (G&A) Expenses: $10.2 million for Q2 2024, down from $13.5 million for Q2 2023.
- Total Operating Expenses: $33.3 million for Q2 2024, compared to $37.3 million for Q2 2023.
- Net Loss: $32.2 million for Q2 2024, or $1.19 per share, compared to $35.5 million, or $1.61 per share, for Q2 2023.
- Shares Outstanding: 26.0 million common shares, 2.1 million pre-funded warrants, and 29.9 million common shares on a fully diluted basis as of June 30, 2024.
INOVIO estimates its cash runway to extend into the third quarter of 2025, with an operational net cash burn estimate of approximately $28 million for Q3 2024. These projections do not include potential future capital-raising activities.
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