Inovio Pharmaceuticals, Inc. (NASDAQ:INO) is a clinical-stage biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. The company's DNA medicines platform harnesses the power of in vivo protein production, featuring optimized design and delivery of DNA medicines that teach the body to manufacture its own disease-fighting tools.
Financials
In the first quarter of 2024, Inovio reported a net loss of $30.5 million, or $1.31 per share, compared to a net loss of $40.6 million, or $1.89 per share, in the same period of 2023. The company's annual net income for 2023 was -$135,117,352. Revenue for the first quarter of 2024 was $0, compared to $115,000 in the first quarter of 2023. The company's annual revenue for 2023 was $832,010. Inovio's operating cash flow for the first quarter of 2024 was -$28.8 million, compared to -$36.7 million in the first quarter of 2023. The company's annual operating cash flow for 2023 was -$124,365,551. Inovio's free cash flow for the first quarter of 2024 was -$28.8 million, compared to -$36.7 million in the first quarter of 2023. The company's annual free cash flow for 2023 was -$124,686,449.
Business Overview
Inovio's lead candidate is INO-3107, which is designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 proteins. These targeted T cells are designed to seek out and kill HPV-6 and HPV-11 infected cells, with the aim of potentially preventing or slowing the growth of new papillomas. In a completed Phase 1/2 clinical trial, 81.3% of patients experienced a reduction in the number of surgical interventions in the year following administration of INO-3107, when compared with the year prior to treatment. The company is on track to submit a Biologics License Application (BLA) for INO-3107 in the second half of 2024 under the FDA's accelerated approval pathway.
In addition to INO-3107, Inovio is actively developing or planning to develop DNA medicines for other indications, including HPV-related oropharyngeal squamous cell carcinoma (OPSCC), glioblastoma multiforme (GBM), and a potential vaccine booster to protect against the Ebola virus. The company previously conducted clinical trials of a DNA medicine candidate for the treatment of HPV-related cervical high-grade squamous intraepithelial lesions (HSIL) but announced in August 2023 that it was ceasing development for this indication in the United States. However, its collaborator ApolloBio Corporation continues to conduct a Phase 3 clinical trial of this candidate in China and plans to seek regulatory approval for and potentially commercialize the candidate in that jurisdiction.
Partnerships and Collaborations
Inovio's partners and collaborators include Advaccine Biopharmaceuticals Suzhou Co, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation (Gates), Coalition for Epidemic Preparedness Innovations (CEPI), Coherus Biosciences, Defense Advanced Research Projects Agency (DARPA), The U.S. Department of Defense (DoD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Kaneka Eurogentec, National Cancer Institute (NCI), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Plumbline Life Sciences, Regeneron Pharmaceuticals, Richter-Helm BioLogics, Thermo Fisher Scientific, the University of Pennsylvania, the Walter Reed Army Institute of Research, and The Wistar Institute.
Research and Development Expenses
In the first quarter of 2024, Inovio's research and development expenses were $20.9 million, compared to $30.2 million in the first quarter of 2023. The decrease was primarily due to lower drug manufacturing, clinical trial expenses, outside services and expensed inventory related to INO-4800 and other COVID-19 studies, as well as lower employee and consultant compensation, including stock-based compensation. General and administrative expenses for the first quarter of 2024 were $10.6 million, compared to $13.9 million in the first quarter of 2023. The decrease was primarily related to a decrease in employee compensation, including non-cash employee and consultant stock-based compensation, and a decrease in other legal expenses.
Liquidity
Inovio's cash, cash equivalents, and short-term investments totaled $105.6 million as of March 31, 2024, compared to $45.3 million as of December 31, 2023. The company recently raised approximately $33.2 million through an offering of common stock and pre-funded warrants in April 2024, which will help support its commercialization efforts for INO-3107 and progress across its pipeline. Inovio estimates its cash runway, including the net proceeds from the April 2024 offering, to extend into the third quarter of 2025.
Recent Developments
Regarding the company's lead candidate, INO-3107, Inovio is on track to submit a BLA for the treatment of recurrent respiratory papillomatosis (RRP) in the second half of 2024 under the FDA's accelerated approval pathway. The company has received feedback from the FDA that the data from its completed Phase 1/2 clinical trial could be used to support the BLA submission. Inovio plans to initiate a confirmatory clinical trial for INO-3107 prior to the BLA submission.
In addition to INO-3107, Inovio is advancing other promising candidates in its pipeline. The company announced a clinical collaboration and supply agreement with Coherus BioSciences in the first quarter of 2024 to evaluate the combination of INO-3112 and LOQTORZI (toripalimab-tpzi) in a planned Phase 3 clinical trial for patients with locoregionally advanced, high-risk, HPV16/18 positive OPSCC. Inovio is also planning to submit plans for a Phase 2/3 study with INO-4201 as an Ebola vaccine booster in the second quarter of 2024 and expects to report the first clinical data from the Phase 1 trial evaluating the anti-SARS-CoV-2 dMAb candidates in the second half of 2024.
Inovio's DNA medicines platform has two innovative components: precisely designed DNA plasmids and the company's proprietary CELLECTRA® delivery devices. The CELLECTRA® devices are designed to optimally deliver Inovio's 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.
Risks and Challenges
In terms of the competitive landscape, Inovio faces competition from large pharmaceutical companies and various development-stage biotechnology companies involved in different vaccine and immunotherapy technologies. However, the company believes that its DNA medicines platform and the potential benefits of INO-3107, such as its ability to generate antigen-specific T cells that are not affected by anti-vector immunity, could make it an important therapeutic option for RRP patients.
Regarding risks, Inovio's business is subject to various risks, including the uncertainty inherent in clinical trials and product development programs, the availability of funding, the ability to manufacture its DNA medicine candidates, the availability or potential availability of alternative therapies or treatments, issues involving patents and intellectual property, and the impact of government healthcare proposals and regulations.
Conclusion
Inovio Pharmaceuticals is making significant progress in advancing its DNA medicines platform and pipeline, with a focus on bringing its lead candidate, INO-3107, to market for the treatment of recurrent respiratory papillomatosis. The company's strong partnerships and collaborations, as well as its innovative delivery technology, position it well to continue delivering on the promise of DNA medicines. However, the company will need to navigate the challenges inherent in the biotechnology industry, including the risks associated with clinical development and regulatory approval, in order to achieve long-term success.