Company guidance, FDA catalysts, dilution risk and cash runway, built from SEC, FDA and ClinicalTrials.gov filings and updated every day.
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| PDUFA Date | Drug | Indication | Type | PoA |
|---|---|---|---|---|
| 2026-10-30 | — | adults with Recurrent Respiratory Papillomatosis (RRP) • Cli | BLA | 65% |
PoA = estimated probability of approval: base rates calibrated against BioRadar's verified FDA outcomes, adjusted for application type, modality, therapy area and cash runway. Not investment advice. See the full PDUFA calendar →
Quoted word for word from the company's press releases filed with the SEC. Timing is the company's own guidance, not a BioRadar estimate.
| Drug | Indication | Most advanced trial | Status |
|---|---|---|---|
| Reluscovtogene Ralaplasmid (INO-4800) | Coronavirus Infection | Phase 2/3 · NCT04642638 | Terminated |
| Bizalimogene Ralaplasmid (VGX-3100) | Cervical Dysplasia | Phase 3 · NCT03721978 | Completed |
| Human Immunodeficiency Virus DNA | HIV-1-infection | Phase 1/2 · NCT03606213 | Completed |
| INO-4700 | Middle East Respiratory Syndrome Coronavirus (MERS | Phase 2 · NCT04588428 | Completed |
| WT1/PSMA/hTERT-encoding Plasmid DNA INO- | Glioblastoma | Phase 1/2 · NCT03491683 | Active not recruiting |
| Rocakinogene Sifuplasmid (INO-9012) | Glioblastoma | Phase 1/2 · NCT03491683 | Active not recruiting |
| DNA Plasmid-encoding Interleukin-12/HPV | Uterine Cervical Neoplasms | Phase 2 · NCT02501278 | Withdrawn |
| HPV6/11-targeted DNA Plasmid Vaccine INO | Respiratory Papillomatosis | Phase 1/2 · NCT04398433 | Completed |
| Imiquimod 5% Cream | Vulvar High Grade Squamous Intraepithelial Lesion | Phase 2 · NCT03180684 | Completed |
| p.DOM-WT1-37 DNA Vaccine | Leukaemia (Acute) | Phase 2 · NCT01334060 | Completed |
| GLS-5300 | Healthy | Phase 1/2 · NCT03721718 | Completed |
| Cisplatin chemotherapy | Uterine Cervical Neoplasms | Phase 2 · NCT02501278 | Withdrawn |
| INO-A002 | Healthy Volunteers | Phase 1 · NCT03831503 | Completed |
| VGX-6150 | Hepatitis C, Chronic | Phase 1 · NCT02027116 | Completed |
| VGX-3400X | Healthy | Phase 1 · NCT01142362 | Completed |
| DNA Plasmid-encoding Interleukin-12 INO- | Metastatic Castration-resistant Prostate Cancer | Phase 1 · NCT03835533 | Completed |
Also used in these trials (approved or third-party drugs, not INO's own candidates): Temozolomide, Atezolizumab, Cemiplimab, Nivolumab, Poly ICLC, Alum.
Source: ClinicalTrials.gov trials sponsored by the company, one row per candidate at its most advanced registered trial. FDA approvals: Drugs@FDA. Wrong or missing drug? Report it
INO holds $36.7M in cash and short-term investments (as of Jun 30, 2026) and burns about $19.8M/quarter from operations, an estimated runway of 5.6 months at that rate (BioRadar estimate, not company guidance).
Dilution pressure: 100 · High
In light of these factors, management believes that there is substantial doubt about the Company's ability to continue as a going concern beyond the first quarter of 2027.10-Q, Aug 2026
Recent financing filings on SEC EDGAR:
Source: SEC EDGAR (XBRL cash flow and financing filings). Dilution Watch: every company ranked → · Get an alert when INO files for a raise →
| Holder | Type | Shares | % of shares | As of |
|---|---|---|---|---|
| RA Capital Management, L.P. | Institution (13G, 5%+) | 10,666,523 | 10.32% | 2026-07-31 |
| FMR LLC | Institution (13G, 5%+) | 8,454,797 | 8.18% | 2026-06-30 |
| JANUS HENDERSON GROUP PLC | Institution (13G, 5%+) | 6,666,295 | 6.45% | 2025-11-28 |
| HIGHBRIDGE CAPITAL MANAGEMENT LLC | Institution (13G, 5%+) | 6,190,475 | 5.99% | 2026-03-31 |
| Jupiter Topco LLC | Institution (13F) | 5,171,053 | 5.00% | 2026-06-30 |
| Vanguard Capital Management | Institution (13G, 5%+) | 4,161,566 | 4.02% | 2026-06-30 |
| Alyeska Investment Group, L.P. | Institution (13G, 5%+) | 4,000,000 | 3.87% | 2025-12-31 |
| Boxer Capital Management, LLC | Institution (13F) | 2,844,994 | 2.75% | 2026-06-30 |
| Adar1 Capital Management, LLC | Institution (13F) | 2,143,910 | 2.07% | 2026-06-30 |
| Shaw D.E. & Co., Inc. | Institution (13F) | 1,351,656 | 1.31% | 2026-06-30 |
| Two Sigma Investments, LP | Institution (13F) | 1,239,778 | 1.20% | 2026-06-30 |
| Eversept Partners, LP | Institution (13F) | 1,035,360 | 1.00% | 2026-06-30 |
Share count 103,397,518 (latest 10-Q/10-K). Insiders: each officer's, director's and 10% owner's latest Form 3, 4 or 5, direct and indirect shares; options are not counted. 5%+ holders: latest Schedule 13D or 13G of each holder above 5%. Institutions: the largest 13F holders (13F quarter ending 2026-06-30). Sources have different dates, so the split is approximate. Source: SEC EDGAR.
| Trade date | Insider | Transaction | Shares | Price | Owned after |
|---|---|---|---|---|---|
| 2026-05-20 filed 2026-05-21 |
BENITO SIMON X |
Option award (A) | 41,800 | – | – |
| 2026-05-20 filed 2026-05-21 |
DANSEY ROGER D |
Option award (A) | 41,800 | – | – |
| 2026-05-20 filed 2026-05-21 |
Weiner David B. |
Option award (A) | 34,200 | – | – |
| 2026-05-20 filed 2026-05-21 |
Weiner David B. |
Option award (A) | 41,800 | – | – |
| 2026-05-20 filed 2026-05-21 |
Shepard Jay |
Option award (A) | 34,200 | – | – |
Only open-market purchases (P) and sales (S) are trading decisions. Awards (A), option exercises (M) and tax withholding (F) are compensation mechanics. Source: SEC Form 4.
| Date | Drug | Type | Run-up 30d | Decision 1d | After 5d |
|---|---|---|---|---|---|
| 2025-05-13 | — | BLA | +22.8% | -1% | +6.7% |
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