INO 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• Our lead candidate is INO-3107, an investigational DNA medicine developed for the treatment of recurrent respiratory papillomatosis, or RRP, a chronic, rare and debilitating disease characterized by the growth of small tumors, or papillomas, in the respiratory tract primarily caused by HPV-6 and/or …

• In January 2026, a new position statement was published in The Laryngoscope (S. R.Best, A. D.Friedman, C. A.Rosen, et al.,“Recurrent Respiratory Papillomatosis Foundation Position Statement on the Management of Adults With RRP,” The Laryngoscope (2026): 1–11, https://doi.org/10.1002/lary.70379) outl…

• In 2023, we received feedback from the FDA that the data from our completed trial of INO-3107 could be used to support the submission of a Biologic License Application, or BLA, for review under the FDA’s accelerated approval program. Utilizing our breakthrough therapy designation, we requested rolli…

• In December 2025, the FDA accepted our BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP and set the Prescription Drug User Fee Act (PDUFA) target date for October 30, 2026. We are now focused on advancing INO-3107 through the regulatory …

• In 2025 we presented key data regarding the development of INO-3107 at several scientific conferences. Highlights from the data include:

相对上期删除的文字 · 来源:10-Q · 2025-11-10

• Our lead candidate is INO-3107 for the treatment of recurrent respiratory papillomatosis, or RRP, a chronic, rare and debilitating disease characterized by the growth of small tumors, or papillomas, in the respiratory tract primarily caused by HPV-6 and/or HPV-11 genotypes. Although mostly benign, t…

• In 2023, we received feedback from the U.S. Food and Drug Administration, or FDA, that the data from our completed trial of INO-3107 could be used to support the submission of a Biologic License Application, or BLA, for review under the FDA’s accelerated approval program. As part of submitting our B…

• During 2025, we have presented key data regarding INO-3107 at several scientific conferences. Highlights from the data include:

• We are developing INO-3112, a DNA medicine candidate targeting HPV 16/18 combined with a DNA plasmid encoding for human IL-12 as an immune activator, for the treatment of oropharyngeal squamous cell carcinoma, or OPSCC, a type of head and neck cancer commonly known as throat cancer. We have entered …

• We are also developing INO-5401, an immunotherapy consisting of three DNA plasmids encoding for three tumor associated antigens, for the treatment of glioblastoma multiforme, or GBM, an aggressive type of brain cancer that accounts for more than 50% of all primary malignant brain tumors. GBM is one …

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• Based on an evaluation carried out as of the end of the period covered by this Quarterly Report, under the supervision and with the participation of our management, including our CEO and CFO, our CEO and CFO have concluded that, as of the end of such period, our disclosure controls and procedures (a…

相对上期删除的文字 · 来源:10-Q · 2025-11-10

• Based on an evaluation carried out as of the end of the period covered by this Quarterly Report, under the supervision and with the participation of our management, including our CEO and CFO, our CEO and CFO have concluded that, as of the end of such period, our disclosure controls and procedures (a…

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• On June 3, 2020, the Company filed a complaint in the Court of Common Pleas of Montgomery County, Pennsylvania against VGXI, Inc. and GeneOne Life Science, Inc., or GeneOne, collectively referred to as “VGXI”, alleging that VGXI materially breached the Company’s supply agreement. The complaint seeks…

• On February 6, 2026, a purported shareholder class action complaint, Carlson v. Inovio Pharmaceuticals, Inc., Jacqueline Shea, and Peter Kies, was filed in the United States District Court for the Eastern District of Pennsylvania, naming the Company, Jacqueline Shea, the Company’s Chief Executive Of…

• On March 5, 2026, a purported shareholder derivative complaint, Shin v. Shea, et al., was filed in the United States District Court for the Eastern District of Pennsylvania, naming Jacqueline Shea, the Company’s Chief Executive Officer, Peter Kies, the Company’s Chief Financial Officer, and seven cu…

• On March 16, 2026, a second shareholder derivative complaint was filed in the United States District Court for the Eastern District of Pennsylvania, captioned Pepito v. Shea, et al.; and on May 1, 2026, a third shareholder derivative complaint was filed in the United States District Corut for the Ea…

相对上期删除的文字 · 来源:10-Q · 2025-11-10

• In June 2020, we filed a complaint in the Court of Common Pleas of Montgomery County, Pennsylvania against VGXI, Inc. and GeneOne Life Science, Inc., or GeneOne, and together with VGXI, Inc. collectively referred to as VGXI, alleging that VGXI had materially breached our supply agreement with them. …

• Following our appeal, in July 2020 VGXI filed counterclaims against us, alleging that we had breached the supply agreement, as well as misappropriation of trade secrets and unjust enrichment. The counterclaims seek injunctive relief, damages, attorneys’ fees, interest, costs and other relief from us…

• We intend to aggressively prosecute the claims set forth in our complaint against VGXI and to vigorously defend ourselves against VGXI’s counterclaims.

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern.

• Our historical financial statements have been prepared under the assumption that we will continue as a going concern. As of March 31, 2026, we had an accumulated deficit of $1.8 billion and had cash, cash equivalents and short-term investments of $37.7 million. These conditions raise substantial dou…

• equivalents and short-term investments as of the filing date, May 13, 2026, together with the net proceeds of $16.0 million from the April 2026 Offering, which closed on April 6, 2026, will enable us to fund our planned operating expenses and capital expenditure requirements into the first quarter o…

• The perception of our ability to continue as a going concern may make it more difficult for us to obtain financing for the continuation of our operations and could result in the loss of confidence by investors and employees. Additional financing may not be available to us when needed or, if availabl…

• We have incurred significant losses in recent years, expect to incur significant net losses in the foreseeable future and may never become profitable.

相对上期删除的文字 · 来源:10-Q · 2025-11-10

• We have incurred significant losses in recent years, expect to incur significant net losses in the foreseeable future and may never become profitable.

• We have experienced significant operating losses over the last several years. As of September 30, 2025, our accumulated deficit was $1.8 billion. We have generated limited revenues, primarily consisting of license revenue, grant funding and interest income. We expect to continue to incur substantial…

• We have limited sources of revenue and our success is dependent on our ability to develop our DNA medicines and proprietary device technology.

• We do not currently generate any revenue from the commercial sale of products. Our ability to generate future revenues depends heavily on our success in:

• •developing and securing United States and/or foreign regulatory approvals for our DNA medicine candidates, including securing regulatory approval for conducting clinical trials with DNA medicine candidates;