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INOVIO PHARMACEUTICALS (INO)

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Earnings summaries and quarterly performance for INOVIO PHARMACEUTICALS.

Recent press releases and 8-K filings for INO.

INOVIO's BLA for INO-3107 Accepted for FDA Review
INO
New Projects/Investments
  • INOVIO announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with Recurrent Respiratory Papillomatosis (RRP).
  • The FDA assigned a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, and is not currently planning to hold an advisory committee meeting to discuss this application.
  • While INOVIO filed the BLA under the accelerated approval pathway, the FDA noted a preliminary conclusion that adequate information was not submitted to justify eligibility for this pathway.
  • INOVIO plans to request a meeting with the FDA to discuss next steps to remain eligible under the accelerated approval program and is not currently planning to seek approval under the traditional pathway.
Dec 29, 2025, 1:20 PM
INOVIO's BLA for INO-3107 Accepted for FDA Review
INO
Product Launch
New Projects/Investments
  • The FDA has accepted INOVIO's Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with Recurrent Respiratory Papillomatosis (RRP).
  • The Prescription Drug User Fee Act (PDUFA) review goal date for INO-3107 is October 30, 2026.
  • The FDA noted a preliminary conclusion that INOVIO has not submitted adequate information to justify eligibility for the accelerated approval pathway, which INOVIO plans to discuss with the agency.
  • Clinical trials demonstrated that 72% of patients experienced a 50-to-100% reduction in surgeries after one year of treatment with INO-3107, with this number increasing to 86% after two years without additional dosing.
Dec 29, 2025, 1:05 PM
Inovio discusses INO-3107 BLA status, pipeline, and financial outlook
INO
Product Launch
New Projects/Investments
Guidance Update
  • Inovio is awaiting BLA acceptance for INO-3107 for recurrent respiratory papillomatosis (RRP), with a rolling submission completed on October 30 and an expected PDUFA date in the middle of next year if priority review is granted.
  • INO-3107 demonstrated a significant reduction in surgeries for RRP patients, with a median of one surgery in the year after treatment compared to four in the prior year, and 28% of patients requiring no surgeries in the first year, increasing to 50% in the second year.
  • The company highlighted INO-3107's clean systemic side effect profile and patient-centric treatment regimen as competitive advantages over Precigen's PRGN-2012, which was priced at $460,000 for a four-dose regimen.
  • Inovio reported $51 million in cash at the end of Q3, with recent fundraising extending the cash runway into Q3 next year, potentially into Q4 with the exercise of Series A warrants, which could add $24 million.
  • The company is also developing INO-3112 for HPV-positive head and neck cancers and INO-5401 for glioblastoma, alongside advancements in its in vivo protein production technologies.
Dec 2, 2025, 1:30 PM
Inovio Provides Update on INO-3107 BLA Submission, Competitive Landscape, and Financial Runway
INO
Product Launch
New Projects/Investments
Guidance Update
  • Inovio submitted a rolling Biologics License Application (BLA) for INO-3107 for recurrent respiratory papillomatosis (RRP) on October 30, expecting agency acceptance by year-end and a PDUFA date in mid-next year if priority review is granted.
  • INO-3107 demonstrated a significant reduction in surgeries for RRP patients, with a median decrease from four surgeries in the prior year to one after treatment, and 50% of patients requiring no surgeries in the second year of treatment. It also has a clean systemic side effect profile compared to the competitor, Precigen's PRGN-2012.
  • Precigen's competing product, PRGN-2012, approved in August and available in late October, is priced at $460,000 for a four-dose regimen, which does not include additional required surgeries.
  • Following recent fundraising, Inovio has a cash runway into the third quarter of next year, which could extend into the fourth quarter if short-term warrants are exercised, enabling investment in launch preparations for INO-3107.
Dec 2, 2025, 1:30 PM
Inovio Provides Update on INO-3107 BLA, Competition, and Financial Runway
INO
Product Launch
New Projects/Investments
Guidance Update
  • Inovio is awaiting BLA acceptance for INO-3107 for recurrent respiratory papillomatosis (RRP), with a rolling submission completed on October 30, 2025, and expects a PDUFA date in mid-2026 if priority review is granted.
  • INO-3107 demonstrated a significant reduction in surgeries for RRP patients, with a median of one surgery in the first year post-treatment compared to four in the prior year, and 50% of patients requiring no surgeries in the second year.
  • The company believes INO-3107 has a preferred product profile over competitor Precigen's PRGN-2012, which was approved in August 2025 and is priced at $460,000 for a four-dose regimen, due to better tolerability and a patient-centric treatment regimen.
  • Inovio's cash and equivalents, including recent fundraising, provide a cash runway into Q3 2026, potentially extending to Q4 2026 if Series A warrants are exercised upon BLA acceptance.
  • Inovio is also advancing other pipeline candidates, including INO-3112 for HPV-positive head and neck cancers (entering Phase 3) and INO-5401 for glioblastoma, and has reported positive clinical proof-of-concept data for its dMAb in vivo protein production program.
Dec 2, 2025, 1:30 PM
INOVIO Pharmaceuticals, Inc. announces pricing of public offering
INO
  • INOVIO Pharmaceuticals, Inc. priced an underwritten public offering of 13,158,000 shares of its common stock at $1.90 per share on November 11, 2025. The underwriters also exercised their option in full on the same day to purchase an additional 1,973,700 shares.
  • The offering is expected to generate approximately $25 million in gross proceeds from the initial offering , and approximately $26.5 million in net proceeds to the company after deducting underwriting discounts, commissions, and estimated offering expenses, including the full exercise of the underwriters' option.
  • The closing of the offering is anticipated on or about November 12, 2025.
Nov 12, 2025, 11:16 AM
INOVIO Announces Pricing of Public Offering
INO
  • INOVIO Pharmaceuticals, Inc. announced the pricing of an underwritten public offering of 13,158,000 shares of its common stock at a public offering price of $1.90 per share.
  • The offering is expected to generate approximately $25 million in gross proceeds, before deducting underwriting discounts and commissions and offering expenses.
  • The underwriters have been granted an option to purchase up to 1,973,700 additional shares of common stock for a period of 30 days.
  • The offering is anticipated to close on or about November 12, 2025, with Piper Sandler & Co. acting as the sole manager.
Nov 11, 2025, 1:40 PM
INOVIO Announces Proposed Public Offering
INO
  • INOVIO Pharmaceuticals, Inc. intends to offer and sell shares of its common stock in an underwritten public offering.
  • All shares in the proposed offering will be sold by INOVIO, with the underwriter having a 30-day option to purchase up to an additional 15% of the shares offered.
  • Piper Sandler & Co. is acting as the sole book-running manager for the offering.
  • The proposed offering is subject to market conditions, and there is no assurance regarding its completion, actual size, or terms.
Nov 10, 2025, 11:09 PM
INOVIO Reports Q3 2025 Financial Results and Provides INO-3107 Regulatory Update
INO
Earnings
Guidance Update
Product Launch
  • INOVIO reported a net loss of ($45.5 million) for Q3 2025, an 81% increase from Q3 2024, with operating expenses at $21.2 million, a 22% decrease.
  • The company held $50.8 million in cash, cash equivalents, and short-term investments as of September 30, 2025, with a projected cash runway into Q2 2026.
  • INOVIO completed the rolling BLA submission for INO-3107, seeking accelerated approval, and expects FDA file acceptance by year-end 2025. If Priority Review is granted, a potential PDUFA date is anticipated in mid-2026.
  • Preparations for the commercialization of INO-3107 are advancing, including ongoing market research, initial pricing strategy development, and finalizing contracts with key partners.
Nov 10, 2025, 9:30 PM
Inovio Reports Q3 2025 Financial Results and Provides INO 3107 Regulatory Update
INO
Earnings
Guidance Update
Product Launch
  • Inovio reported a net loss of $45.5 million, or $0.87 per share, for Q3 2025, primarily driven by a $22.5 million non-cash loss on fair value adjustments related to warrant liabilities.
  • Operating expenses for Q3 2025 decreased 22% to $21.2 million compared to Q3 2024, with a 25% reduction for the first nine months of 2025 versus the same period last year.
  • The company completed the rolling submission of its Biologics License Application (BLA) for INO 3107 and expects final FDA acceptance by year-end 2025, with a potential PDUFA date around mid-2026 if priority review is granted.
  • Inovio finished Q3 2025 with $50.8 million in cash, cash equivalents, and short-term investments, projecting a cash runway into the second quarter of 2026.
  • Commercial preparations for INO 3107 are advancing, with the company expecting the majority of the market opportunity to remain available upon their potential mid-2026 entry, despite a competitor's recent launch.
Nov 10, 2025, 9:30 PM