Results & Analyst Call Summary

Conference date: August 8, 2024 @ 1:30 PM Pacific Time
for quarter ending: June 30, 2024 (Q2, second quarter)

Forward-looking statements

Overview: Still has significant cash. Another delay for BLA submission for INO-3107.

Basic data (GAAP):

Revenue was $101 thousand, down sequentially from $0 thousand, and down from $226 thousand in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $32 million, down sequentially from negative $31 million, and up from negative $36 million year-earlier.

EPS (earnings per share, diluted) was negative $1.19, up sequentially from negative $1.31, and up from negative $1.61 year-earlier, due to dilution.

Guidance:

Has cash to last into Q3 2025. Expects $28 million cash burn in Q3.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "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 have recently identified a manufacturing issue with the single use disposable administration component of our device that we believe is resolvable, and that will impact the timing of our BLA submission. We are taking corrective steps to address the issue, and while we have not altered our ultimate expectations for INO-3107 to be a potentially transformative therapeutic option for RRP patients that could be the first DNA medicine approved for use in the United States, we now expect to be able to submit the BLA in mid-2025." Has reduced operating spend and working on continuing that trend.

In April 2024 raised $33 milion with a common stock and pre-funded warrants offering.

Closer than ever on bringing DNA based medicines to the U.S. markets. Could submit the BLA for INO-3107 for RRP in 2025. Continues to work on restructuring the organization.

The INO-3107 for recurrent respiratory papillomatosis (RRP) BLA submission is on track for 2025. Will use the Accerated Approval pathway, based on Phase 2 data. The Phase 3 trial for RRP should begin in 2024. 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. Will also request a rolling review and priority review. But additional FDA meetings are necessary. An issue with manufacturing the single use component of the Cellectra delivery device is causing a delay. 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. More data will be released in Q4 2024.

INO-3112, which target HPV-related cancers, has received FDA feedback on the proposed trial design for HPV positive throat cancer. Also submitted trial design to EU regulators. Will be combined with Loqtorzi, a PD-1 inhibitor. The target is oropharyngeal squamous cell carcinoma (OPSCC).

Still hopes to advance INO-5401 for GBM (brain cancer) to the next trial, with partners.

INO-4201 for ebola revised Phase 2/3 protocol to be submitted to FDA in Q3 2024. Has strong antibody response data.

Inovio is also working to advance its oncology product candidate INO-5401 glioblastoma (GBM). 5401 Phase 1/2 data is being finalized. The Ebola vaccine candidate, INO-4201, data from the Phase 1b trial was positive and now in discussions with FDA on the Phase 2/3 trial. Progress for these candidates has continued in the areas of manufacturing, regulatory submissions, and partnership discussions. The next stage of clinical development will most likely require additional funding or partnerships.

First dMAb trial for Covid-19 is being prepared.

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 $110 million, up sequentially from $106 million. In April 2024 generated $33 million from selling common stock and warrents. No debt at end of Q1.

R&D expense was $23 million. General and administrative expense was $10 million. Goodwill impairment $0 million. Total operating expenses were $33 million. Operating profit negative $33 million. Interest and other income $1 million.

Q&A selective summary:

3107, when did the manufacturing issue emerge? Resolution? A recent issue, just the last couple of weeks, during testing for BLA submission. A plastic molded part. Hope to resolve quickly. Was not part of the pre-BLA meeting with FDA. Issue occurs at a low rate.

Phase 3 trial timing from issue? Issue must be resolved before Phase 3 trial is started. Will share all information with the FDA.

3107 Phase 3 design with EU regulators? We have alignment for a future filing, including placebo-controlled nature of it. Also include patients with only 2 surgeries in the prior year.

Op ex impact from device problem? Time is mainly for testing once the issue is fixed. Will report on expense impact next quarter.

Redosing study will be a separate study, not part of the confirmatory Phase 3 trial.

We believe we have a straightforward path to resolve the issue.

Redosing study will be a post-approval study. Will require a larger sample size. It is not required for regulatory submissions in the US or EU.

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