Results & Analyst Call Summary

Conference date: March 18, 2025 @ 1:30 PM Pacific Time
for quarter ending: December 31, 2025 (Q4, fourth quarter)

Forward-looking statements

Overview: Resolved the Cellectra device issue, on track to begin rolling BLA for INO-3107 midyear 2025.

Basic data (GAAP):

Full year 2024 data: Net loss $107 million. EPS negative $3.95.

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

Net income was negative $19.4 million, up sequentially from negative $25.1 million, and up from negative $25.0 million year-earlier.

EPS (earnings per share, diluted) was negative $0.65, up sequentially from negative $0.89, and up from negative $1.10 year-earlier.

Guidance:

Cash runway into Q1 2026. Cash burn in Q1 2025 about $27 million. May raise more cash.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "Inovio's recent progress puts us on the cusp of achieving several long-term goals for our DNA medicines, most importantly the submission of our first BLA and potential transition to a commercial-stage company. By resolving the previously announced device array component issue, we are back on track to submitting our first BLA for INO-3107 to the FDA. We anticipate starting our submission in mid-2025 with non-device related modules under the agency's rolling submission program, assuming it is granted, with the goal of having the complete submission accepted for priority review before the end of the year. We continue to believe that INO-3107 has the potential to be the preferred product candidate offering durable clinical benefit, tolerability and a patient-centric dosing regimen and are moving forward with urgency."

Plans to submit the BLA for INO-3107 for RRP in mid-2025, including the device component. 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.

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. 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) and 50% complete response (CR). An issue with manufacturing the single use component of the Cellectra delivery device was 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, but finalizing Phase 3 plans with FDA.

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.

$72 million cash was raised with two ATMs in 2024, one in April and one in December.

Cash and equivalents balance ended at $94 million, up sequentially from $85 million. No debt.

Q4 2024 R&D expense was $ million. General and administrative expense was $ million. Goodwill impairment $0 million. Total operating expenses were $20.5 million. Operating profit negative $ million. Interest and other income net $ million.

Full year 2024 R&D expense was $76 million. General and administrative expense was $37 million. Goodwill impairment $0 million. Total operating expenses were $113 million. Operating profit negative $112 million. Interest and other income net $5 million.

Q&A selective summary:

3107, do you need another FDA meeting? We had a pre-BLA meeting prior to finding the breakage. Remaining modules were aligned. So rolling submission midyear. We do not need another meeting, but we need to request to have the rolling submission.

Cellectra testing? We need to repeat a number of tests. We use an external testing house. Testing should start very soon, should complete in first half of 2025.

DMAb half-life data? We have not released that yet. But so far holding up for 72 weeks.

DMAb near-term focus? Really excited with results, including safety. Broad range of targets was on the slide, will update over time.

We expect the FDA will have accepted the full BLA before the end of this year. Will need to initiate the Phase 3 trial, but will be ready to do that.

We have done research with payers, we expect rare disease pricing, could be $200 thousand per year, we are using a therapy that has a $360 thousand price tag.

Can DMAb antibody production be turned off if necessary? There are factors that could be used to turn off expression, but at first we won't be looking at targets that need that.

3107 label, competition? Strong product profile. Durable good efficacy. Patient-centric treatment regimen, administered in doctor's office. Will reveal more about label after we file the BLA.

Still seeing large number of RRP cases in adults in countries where vaccination rates are low. Those rates are also still low in American males. So RRP likely to continue for several generations, though pediatric cases are declining.

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