On May 13, 2025 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, reported its financial results for the first quarter of 2025 and provided an update on recent company developments (Press release, Inovio, MAY 13, 2025, View Source [SID1234652969]).

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"I’m pleased to confirm that we remain on track to submit our BLA for INO-3107 this year. As previously stated, our goal is to begin rolling submission in mid-2025, complete the submission in the second half of 2025 and receive file acceptance from the FDA by year end. If we receive priority review, it could allow for a PDUFA date in mid-2026," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "We continue to focus our efforts and resources toward bringing this important product candidate to patients eager for a non-surgical therapeutic option to treat this devastating disease. Based on market research, we believe INO-3107 could be the preferred product for patients and providers, if approved. Beyond INO-3107, we are excited about the recently announced promising data from a proof-of-concept Phase 1 clinical trial with our next-generation DMAb technology, as well as the potential of our entire DNA medicines pipeline."

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
The DV testing for INO-3107 has been initiated and is anticipated to be completed in the first half of 2025. INOVIO plans to begin rolling submission of the BLA in mid-2025 under FDA’s accelerated approval program, subject to FDA concurrence, with the goal of completing the submission in the second half of 2025 and receiving FDA acceptance of the submission by the end of the year. FDA has previously awarded breakthrough therapy designation for INO-3107 and INOVIO plans to request priority review of its BLA, which if granted would allow for an FDA approval decision (PDUFA date) in mid-2026.

INOVIO is conducting ongoing market research with physicians, patients and payors to support its commercial readiness plans. Additionally, clinical and immunology data from a Phase 1/2 trial was published in the peer-reviewed scientific journal Nature Communications in February 2025 and longer-term follow up data was submitted to another peer-reviewed journal for publication. INOVIO has presented key efficacy, safety, immunological and durability data from the Phase 1/2 trial at a number of scientific conferences, including the following:

National HPV Conference (April 15)
World Vaccine Congress (April 21)
Festival of Biologics (April 23)
European Laryngological Society (ELS) Annual Congress (May 9)
American Society of Gene and Cell Therapy (May 13)
On May 14th INOVIO will also be presenting at the American Broncho-Esophagological Association Combined Otolaryngology Spring Meeting (ABEA/COSM), the largest US national meeting for otolaryngologists, the specialist physicians who treat the majority of RRP patients.

Available abstracts are posted to INOVIO’s website following presentations.

DNA-Encoded Monoclonal Antibodies (DMAbs)
In the first quarter, INOVIO and its collaborators announced top-line interim results from an ongoing Phase 1 proof-of-concept trial evaluating its DMAb technology. Additional data from this trial will be presented at the annual meeting of the American Society of Gene and Cell Therapy in May. The data is also anticipated to be published in a peer-reviewed journal. As previously announced, the interim results are currently available in preprint form on Research Square. In the trial, which used monoclonal antibodies against COVID-19 as proof-of-concept targets, 100% (24/24) of participants who reached week 72 maintained biologically relevant levels of DMAbs, confirming the durability of in vivo antibody production. Notably, no participant developed anti-drug antibodies, a common challenge observed in other gene-based delivery platforms, such as adeno-associated virus-mediated antibody expression.

First Quarter 2025 Financial Results

Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2025, decreased to $16.1 million from $20.9 million for the same period in 2024. The decrease was primarily the result of lower drug manufacturing and immunology expenses related to INO-3107, lower contract labor expenses and lower expensed inventory, partially offset by higher engineering professional and outside services related to our device development, among other variances.

General and Administrative (G&A) Expenses: G&A expenses decreased to $9.0 million for the three months ended March 31, 2025 from $10.6 million for the same period in 2024. The decrease was primarily related to a decrease in legal expenses and employee and consultant stock-based compensation, among other variances.

Total Operating Expenses: Total operating expenses decreased to $25.1 million for the three months ended March 31, 2025 from $31.5 million for the same period in 2024.

Net Loss: Net loss for the three months ended March 31, 2025 decreased to $19.7 million, or $0.51 per basic and diluted share, from a net loss of $30.5 million, or $1.31 per basic and diluted share, for the three months ended March 31, 2024.

Shares Outstanding: As of March 31, 2025, INOVIO had 36.7 million common shares outstanding and 51.3 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding common stock warrants, including pre-funded warrants and stock options, restricted stock units and convertible preferred stock.

Cash, Cash Equivalents and Short-term Investments: As of March 31, 2025, cash, cash equivalents and short-term investments were $68.4 million, compared to $94.1 million as of December 31, 2024.
INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended March 31, 2025, which can be accessed at: View Source

Cash Guidance
INOVIO estimates its current cash, cash equivalents and short-term investments balances to support the company’s operations into the first quarter of 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the second quarter of 2025. These 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 View Source