Results & Analyst Call Summary

Conference date: May 13, 2025 @ 1:30 PM Pacific Time
for quarter ending: March 31, 2025 (Q1, first quarter)

Forward-looking statements

Overview: On track, but no obvious progress, in the INO-3107 filing.

Basic data (GAAP):

Revenue was $65 thousand, up sequentially from $0 thousand, and up from $0 thousand in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $19.7 million, down sequentially from negative $19.4 million, and up from negative $30.5 million year-earlier.

EPS (earnings per share, diluted) was negative $0.51, up sequentially from negative $0.65, and up from negative $1.31 year-earlier.

Guidance:

Believes cash will last into Q1 2026. Believes cash burn in Q2 will be about $22 million.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "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. 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." Believes 3107 will be preferred to its likely to be approved first competitor.

Plans to start the rolling submition the BLA for INO-3107 for RRP in mid-2025, including the device component. Complete submission by end of 2025. INO-3107 planning go-to-market strategy. Pricing will be in line with rare disease pricing, feedback from payers is good. Will build field teams in 2025. Also planning confirmatory Phase 3 trial. PDUFA date could be mid 2026. Is currently manufacturing the new device.

Emphasized progress in the DMAb (DNA-encoded monoclonal antibody) technology. Announced interim data from the proof-of-concept DMAb Phase 1 clinical trial (for Covid 19). 100% (24/24) of participants who reached week 72 maintained biologically relevant levels of DMAbs.

The INO-3107 for recurrent respiratory papillomatosis (RRP) BLA submission is on track for mid 2025. Will use the Accerated Approval pathway, based on Phase 2 data. In February 2025 published results for Phase 2 in Nature Communications. The Phase 3 trial for RRP should begin in 2025. The FDA granted Breakthrough Therapy designation in September 2023. FDA said will not require completion of a Phase 3 trial for submission of the BLA based on Phase 2 data under the accelerated approval program. Updated durability data supports application and shows mechanism of action, with 86% decrease in surgeries (OS) over the first 2 years and 50% complete response (CR). An issue with manufacturing the single use component of the Cellectra delivery device was causing a delay. DEvice is currently begin tested.Believe payers will treat INO-3107 as a specialty therapy. Believes there are about 14 thousand active RRP cases in the U.S. and similar prevalence in the EU. Working towards applying for authorization in EU, which will require the Phase 3 data.

Believes 14,000 RRP patients for INO-3107 in U.S. at present. Can be administered in a physician's office.

INO-3112, which target HPV-related cancers, has received FDA feedback on the proposed trial design for HPV positive throat cancer. Also discussed with EU regulators. Will be combined with Loqtorzi, a PD-1 inhibitor. The target is oropharyngeal squamous cell carcinoma (OPSCC) or throat cancer. No date for trial initiation yet, but finalizing Phase 3 plans with FDA.

DMAbs (DNA-encoded monoclonal antibodies) had Phase 1 top line interim results announced in Q1 2025. Presentation scheduled for American Society of Gene and Cell Therapy in May 2025. All 24 participants reached biologically revelant levels of DMAbs for Covid-19. The trial is ongoing. There is no plan so go forward with the Covid indication, it is just a proof of concept. DMAbs could also produce proteins other than antibodies.

INO-4201 for ebola revised Phase 2/3 protocol was aligned with FDA in Q4 2024. Has strong antibody response data. It is a potential booster for Ervebo, which is an approved vaccination. The next stage of clinical development will most likely require additional funding or partnerships.

Inovio is also working to advance its oncology product candidate INO-5401 glioblastoma (GBM). 5401 Phase 1/2 data is being finalized. The next step will be a placebo-controlled Phase 2 trial. 5401 is also being studied at the Basser Center in a Phase 1 trial to prevent cancer in people with BRCA mutations.

Collaborator ApolloBio continues recruitment into its Phase 3 trial evaluating INO-3100 as a potential treatment for HPV 16/18 positive cervical dysplasia in China.

Inovio also has a variety of other vaccines in clinical or preclinical study. See the Inovio Pipeline for an overview.

Cash and equivalents balance ended at $68.4 million, down sequentially from $94 million. No debt.

Q4 2024 R&D expense was $16 million. General and administrative expense was $9 million. Goodwill impairment $0 million. Total operating expenses were $25 million. Operating profit negative $25 million. Interest and other income net $0.8 million. Change in fair value of stock warrant liability $3.7 million. Gain on investment $0.7 million. Net unrealized gain on securities $0.1 million.

Q&A selective summary:

Will provide more color at the coming meeting for otolaryngologists, the primary treaters of RRP.

New RRP cases continue to appear every year, despite the availability of HPV vaccines.

Surgery sparing claim in the label, differentiation from competitor? FDA recongnizes that is a clinical benefit, we have shown a statistically significant reduction in surgeries for 3107.

Outside the U.S., we will wait until we have the Phase 3 data. Our next priority is to get a protocol for continued treatement.

DMAb initial indications? Not disclosing. Very broad group of targets. Could be enzyme replacement therapies.

Priority review, given another product could be on the market. Precigen therapy has some problems, we believe there is a population that can only be treated with 3107, so we think we have a strong argument for the FDA to continue with priority review.

Pricing? We think a comparable product is priced at $360,000 per year.

HPV genotype in Phase 3 trial? We saw a normal split in our Phase 2, we hope to recuite a typical population in the Phase 3. With 100 patients we should have a good chance to replicate the typical population.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: