Results & Analyst Call Summary

Conference date: November 14, 2024 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2024 (Q3, third quarter)

Forward-looking statements

Overview: On track to submit BLA for INO-3107 for respiratory papillomatosis in mid-2025.

Basic data (GAAP):

Revenue was $0 thousand, down sequentially from $101 thousand, and down from $388 thousand in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $25.1 million, up sequentially from negative $32 million, and up from negative $33.9 million year-earlier.

EPS (earnings per share, diluted) was negative $0.89, up sequentially from negative $1.19, and up from negative $1.52 year-earlier.

Guidance:

Cash should last into Q3 2025. Estimated $24 million cash burn in q4.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "We continue to be focused on advancing INO-3107 and delivering a non-surgical option to RRP patients. Toward this goal, we expect to have all non-device modules for our BLA completed by year end, while in parallel we continue to implement the plan to resolve the previously announced manufacturing issue with the single-use array component of the device. With this progress, we continue to target the submission of our BLA in mid-2025. Our development of INO-3107 is supported by a growing body of research that collectively points to INO-3107's potential to be an important therapeutic option for all RRP patients regardless of the severity of their disease. We recently presented new immunology data highlighting the ability of INO-3107 to induce new populations of T cells that travel to the airway tissue and papilloma and correspond with clinical benefit. We've also presented our full safety and efficacy data, demonstrating that INO-3107 was shown to be well tolerated and have clinical benefit in the Phase 1/2 trial. Additionally, by the end of year, we anticipate announcing long-term clinical durability data. We continue to believe INO-3107 has the potential to become the preferred choice for the broadest number of RRP patients, healthcare providers and payors, if approved."

Inovio and its manufacturer now has a resolution available for its device issue. But will take time to implement, so mid-2025 BLA. 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.

Non-device related modules for INO-3107 should be submitted by end of 2024. Could submit the BLA for INO-3107 for RRP in mid-2025, including the device component.

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. 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. Full data in Q3 2024 supports application and shows mechanism of action, with 81% decrease in surgeries (OS). CR rate was 28%. 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.

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.

Still hopes to advance INO-5401 for GBM (brain cancer) to the next, Phase 2 trial, with partners. Continues dosing patients in GBM-001 trial.

INO-4201 for ebola revised Phase 2/3 protocol to be discussed with FDA in Q4 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 $85 million, down sequentially from $110 million. No debt.

R&D expense was $19 million. General and administrative expense was $9 million. Goodwill impairment $0 million. Total operating expenses were $27 million. Operating profit negative $27 million. Interest and other income $2 million.

Q&A selective summary:

KOLs in the field have been very impressed by the data.

Steps for resolving manufacturing issue? Issue is with single use disposable component. Understand the problem, making progress with implementing a solution.

3112 trial also depends on resolving the device issue.

Competion? Confident our product will be prefered. The competitor uses an adenovirus, trials are conducted in a different way, so hard to compare data. Their treatment regimen involves surgeries, ours does not.

3107 confirmatory trial design will be placebo controlled. Will be randomized. Will be about 100 patients with 2 to 1 randomization. No redosing in study. Longer follow-up to characterize the full benefit. Must start the trial ahead of the BLA submission, so mid-2025.

Precigen (PGEN) reported plans to introduce AdenoVerse in 2025? We believe our product will be prefered by patients and doctors. We have not seen their full data package yet. We do not know when they will be able to start marketing their product.

[No question on any plans to raise cash]

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