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INOVIO (NASDAQ: INO) details Q1 loss and INO-3107 accelerated FDA review

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

INOVIO Pharmaceuticals reported a first-quarter 2026 net loss of $19.7 million, or $0.28 per share, roughly in line with the prior year. Operating expenses fell to $21.9 million from $25.1 million as both R&D and G&A spending decreased.

The company ended March 31, 2026 with $37.7 million in cash, cash equivalents and short-term investments, before adding $16.0 million of net equity offering proceeds in April. Management expects this liquidity to fund operations into the first quarter of 2027, beyond the FDA’s target October 30, 2026 PDUFA date for lead candidate INO-3107.

The Biologics License Application for INO-3107 in recurrent respiratory papillomatosis is under active FDA review in the accelerated approval program, following completion of the mid-cycle review. INOVIO is preparing for a potential 2026 U.S. commercial launch and pursuing partnerships on other pipeline assets, including a GBM collaboration with Akeso for INO-5412.

Positive

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Negative

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Insights

INOVIO narrows spending, sustains losses while its lead BLA advances under FDA review.

INOVIO cut operating expenses to $21.9 million in Q1 2026 from $25.1 million a year earlier, mainly through lower R&D and G&A. Net loss remained about $19.7 million, but the per-share loss improved to $0.28 because the share count increased.

Cash, cash equivalents and short-term investments were $37.7 million at March 31, 2026, down from $58.5 million at year-end, before the additional $16.0 million raised in April. With an estimated Q2 2026 cash burn of about $18 million, management projects funding into the first quarter of 2027, covering the October 30, 2026 PDUFA date for INO-3107.

The BLA for INO-3107 in recurrent respiratory papillomatosis is under accelerated-approval review, and the FDA has highlighted eligibility for this pathway as a potential issue. INOVIO is advancing commercial preparations and highlighting what it views as a differentiated profile, but ultimate outcomes depend on the FDA’s final decision and future disclosures.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Net loss Q1 2026 $19.7 million Three months ended March 31, 2026
Net loss per share Q1 2026 $0.28 basic and diluted Three months ended March 31, 2026
Total operating expenses $21.9 million Q1 2026 vs $25.1 million in Q1 2025
R&D expenses $14.1 million Three months ended March 31, 2026
G&A expenses $7.9 million Three months ended March 31, 2026
Cash and short-term investments $37.7 million As of March 31, 2026, before April 2026 $16.0M raise
PDUFA date for INO-3107 October 30, 2026 Target FDA action date under accelerated approval program
Equity offering proceeds $16.0 million Net proceeds from April 2026 underwritten public equity offering
Biologics License Application (BLA) regulatory
"Biologics License Application (BLA) for INO-3107 actively being reviewed under the accelerated approval program"
A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.
accelerated approval program regulatory
"BLA for INO-3107 under the accelerated approval program and set a target PDUFA date"
A regulatory pathway that lets a drug or treatment reach the market sooner for serious or life‑threatening conditions based on early signs of benefit (such as lab tests or short‑term results) rather than long‑term proof. It matters to investors because it can accelerate revenue and competitive advantage but carries higher risk: the approval depends on follow‑up studies, and if those fail regulators can withdraw the approval, which can sharply affect a company’s value.
PDUFA date regulatory
"with a target Prescription Drug User Fee Act (PDUFA) date of October 30, 2026"
PDUFA date is the deadline the U.S. Food and Drug Administration sets to complete its review of a drug or biologic application and decide whether to approve it. Investors watch it like a court verdict date: the decision can unlock sales and growth if approved or sharply reduce expected value if denied, so markets often move significantly as the date approaches or when the outcome is announced.
Recurrent Respiratory Papillomatosis (RRP) medical
"potential commercial launch for INO-3107 as a treatment for adults with Recurrent Respiratory Papillomatosis (RRP)"
Recurrent respiratory papillomatosis (RRP) is a rare condition in which growths caused by the human papillomavirus (HPV) repeatedly form in the throat and airways, often disrupting breathing and voice. It typically requires repeated treatments or surgeries because the growths tend to come back, like weeds that need regular trimming. Investors care because persistent disease creates ongoing demand for therapies, devices, and follow-up care, affecting revenue streams, clinical trial prospects, and regulatory considerations.
DNA medicines technical
"a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people"
common stock warrant liabilities financial
"Common stock warrant liabilities | 24,929,459 | | 29,067,162"
Revenue $0 in Q1 2026 vs $65,343 in Q1 2025 Revenue declined versus the prior-year period level of $65,343
Net loss $19.7 million Net loss was similar to the Q1 2025 net loss of $19.7 million
Net loss per share $0.28 basic and diluted Improved from $0.51 basic and diluted in Q1 2025
Guidance

INOVIO estimates current cash, cash equivalents and short-term investments will support operations into the first quarter of 2027.

0001055726FALSE00010557262026-05-132026-05-13

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
 
 
FORM 8-K
 
 
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 13, 2026
 
 
Inovio Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
 
 
 
Delaware 001-14888 33-0969592
(State or other jurisdiction
of incorporation)
 (Commission
File Number)
 
(IRS Employer
Identification No.)
 
660 W. Germantown Pike Suite 110
Plymouth Meeting, PA 19462
(Address of principal executive offices, including zip code)
(267) 440-4200
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
 
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 



 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class Trading
Symbol(s)
 Name of each exchange
on which registered
Common Stock, $0.001 par value INO The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company  
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐
 
 
 




Item 2.02    Results of Operations and Financial Condition.

On May 13, 2026, Inovio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 hereto are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.


Item 9.01    Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number
99.1
Press Release, dated May 13, 2026 (filed herewith)
104Cover Page Interactive Data File (formatted as inline XBRL).




SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
  INOVIO PHARMACEUTICALS, INC.
Date: May 13, 2026  By: /s/ Peter Kies
   Peter Kies
   Chief Financial Officer



Exhibit 99.1
picture3a.jpg
INOVIO Reports First Quarter 2026 Financial Results and Recent Business Highlights

Biologics License Application (BLA) for INO-3107 actively being reviewed under the accelerated approval program by the U.S. Food and Drug Administration (FDA) with a target Prescription Drug User Fee Act (PDUFA) date of October 30, 2026
Commercial readiness plans continue to advance in anticipation of a potential commercial launch for INO-3107 as a treatment for adults with Recurrent Respiratory Papillomatosis (RRP)
Clinical trial collaboration and supply agreement announced with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of glioblastoma (GBM) in a Dana-Farber Cancer Institute-sponsored trial
Current cash, cash equivalents, and short-term investments anticipated to fund operations into first quarter 2027, beyond the target PDUFA date

PLYMOUTH MEETING, PA – May 13, 2026 – INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced its financial results for the first quarter ended March 31, 2026 and provided an update on recent company developments.

“We remain focused on advancing INO-3107 toward its target PDUFA date to ensure that every RRP patient has access to therapeutic options that work for them to reduce the need for surgery. We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease, and that INO-3107 has the potential to become the preferred product by patients and their physicians, if approved, based on clinical results, tolerability data and the simplicity of its patient-centric treatment regimen that does not require additional surgeries during the dosing window,” said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. “While the BLA for INO-3107 is under active review, we continue to advance our commercial readiness plans in anticipation of a 2026 approval, as well as leverage the power of partnerships to advance other promising candidates in our pipeline.”

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
INO-3107 is INOVIO’s lead product candidate. It has been developed as a potential treatment for RRP, a rare and debilitating disease of the respiratory tract caused by infection with HPV-6 and/or HPV-11. In December 2025, the FDA accepted for review the company’s BLA for INO-3107 under the accelerated approval program and set a target PDUFA date for October 30, 2026. Since then, the BLA has been under active review by the FDA, including the recent completion of the mid-cycle review meeting. INOVIO is focused on advancing INO-3107 through the regulatory process and working with the FDA as they complete their review of the BLA, including addressing the potential review issue they noted in their file acceptance letter regarding eligibility for review under the accelerated approval program. INOVIO continues to strongly believe that INO-3107 fulfills the criteria for accelerated approval by meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. As a part of communications about the mid-cycle review, the FDA



has reiterated their intention to schedule the previously agreed to informal meeting to discuss their preliminary commentary on eligibility for review under the accelerated approval program.

INOVIO continues to engage with the RRP community, including presenting data from our Phase 1/2 trial of INO-3107 at the Combined Otolaryngology Spring Meeting (COSM), the premier educational and technology forum for the specialists who treat RRP. INOVIO will also be presenting at the upcoming American Society of Clinical Oncology (ASCO) Annual Conference.

In anticipation of a potential approval in 2026, INOVIO continues to advance commercial readiness plans, including incorporating key learnings from the launch of a competitor’s recently approved RRP product. INOVIO believes INO-3107 has a positively differentiated product profile. INOVIO plans to commercialize INO-3107 itself in the U.S., with the support of a contract sales organization, and has engaged or identified key commercial partners, including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient HUB.

INO-5412
In March 2026, INOVIO announced a clinical trial collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 (INO-5401 plus INO-9012 in a single vial) in combination with cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of glioblastoma (GBM). The combination therapy will be studied as a part of the INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute and conducted by Mass General Brigham Cancer Care Inc. This novel combination builds on INOVIO’s previous promising research in GBM and could potentially benefit patients by providing additional checkpoint inhibition through CTLA-4 binding.

Next-Generation DNA Medicine Candidates
INOVIO presented promising data from our next-generation DNA-Encoded Monoclonal Antibody (DMAb™) and DNA-Encoded Protein (DPROT) programs at several recent scientific conferences. Based on positive preclinical data on Factor VIII production for Hemophilia A, INOVIO is developing additional DPROT indications in the rare disease space, including Fabry disease and Hypophosphatasia (HPP), and is in discussions with potential partners to accelerate development of this promising platform.

General Corporate
INOVIO remains focused on financial discipline, directing resources to advance the INO-3107 program toward a potential 2026 approval and preparing for commercialization. The company strengthened its balance sheet with an underwritten public equity offering in April 2026. Net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $16.0 million.

First Quarter 2026 Financial Results

Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2026 decreased to $14.1 million from $16.1 million for the same period in 2025. The decrease was primarily the result of lower employee and consultant compensation, including stock-based compensation, lower engineering outside services related to our device development, and lower expensed inventory, among other variances.

General and Administrative (G&A) Expenses: G&A expenses decreased to $7.9 million for the three months ended March 31, 2026 from $9.0 million for the same period in 2025.

Total Operating Expenses: Total operating expenses decreased to $21.9 million for the three months ended March 31, 2026 from $25.1 million for the same period in 2025.




Net Loss: INOVIO’s net loss for the three months ended March 31, 2026 was $19.7 million, or $0.28 per basic and diluted share, compared to a net loss of $19.7 million, or $0.51 per basic and diluted share, for the three months ended March 31, 2025.

Cash, Cash Equivalents and Short-term Investments: As of March 31, 2026, cash, cash equivalents and short-term investments were $37.7 million (excluding net proceeds from the April 2026 offering of $16.0 million), compared to $58.5 million as of December 31, 2025.


Cash Guidance
INOVIO estimates that current cash, cash equivalents and short-term investments balances will support operations into the first quarter of 2027, beyond the target PDUFA date for INO-3107. This projection includes the net proceeds of $16.0 million from the public offering in April 2026, as well as an operational net cash burn estimate of approximately $18 million for the second quarter of 2026. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake.

Conference Call / Webcast Information
INOVIO's management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO's financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO's website at http://ir.inovio.com/events-and-presentations/default.aspx.

About INOVIO's DNA Medicines Platform
INOVIO’s DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO’s proprietary investigational medical device, CELLECTRA. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body’s cells can download to produce specific proteins to target and fight disease. INOVIO’s proprietary CELLECTRA delivery devices are designed to optimally deliver its DNA medicines to the body’s cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms.

About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing innovative DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com.

Forward-Looking Statements
This press release contains certain forward-looking statements relating to our business, including the timing and success of preclinical studies and clinical trials; the ability to obtain and maintain regulatory approval of our product candidates; the FDA's acceptance of our BLA for INO-3107 with a PDUFA target action date set for October 30, 2026; a yet-to-be scheduled meeting with the FDA to discuss eligibility for the accelerated approval program; the potential benefits of INO-3107 and our other potential product candidates, including our belief that INO-3107 has a positively differentiated product profile and the potential to become the preferred product by patients and their physicians, if approved; the clinical collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of GBM in the INSIGhT trial; the scope, progress and expansion of developing and commercializing our product candidates, including the anticipated commercial launch of INO-3107, if approved; our anticipated growth strategies; our ability to establish and maintain development partnerships; our estimated operational net cash burn of approximately $18 million for the second quarter of 2026; and the expected sufficiency of our cash resources into the first quarter of 2027. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials,



product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

Contacts
Media: Jennie Willson, (267) 429-8567, communications@inovio.com
Investors: Peter Vozzo - ICR Healthcare, (443) 213-0505, investor.relations@inovio.com
































Inovio Pharmaceuticals, Inc.
CONSOLIDATED BALANCE SHEETS
March 31, 2026
December 31, 2025
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$26,271,650
$44,273,319
Short-term investments
11,409,607
14,239,145
Prepaid expenses and other current assets, including from affiliated entity
1,758,348
2,610,882
Total current assets
39,439,605
61,123,346
Fixed assets, net
2,210,759
2,527,603
Investments in affiliated entity
2,103,688
Operating lease right-of-use assets
6,114,303
6,542,923
Other assets
2,012,475
2,012,475
Total assets
$49,777,142
$74,310,035
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses
$9,267,415
$11,053,618
Accounts payable and accrued expenses due to affiliated entity
74,473
Accrued clinical trial expenses
817,331
650,680
Common stock warrant liabilities
24,929,459
29,067,162
Operating lease liability
2,908,820
2,822,622
Total current liabilities
37,923,025
43,668,555
Operating lease liability, net of current portion
5,786,235
6,545,204
Total liabilities
43,709,260
50,213,759
Stockholders’ equity:
Preferred stock
Common stock
69,773
68,997
Additional paid-in capital
1,841,482,163
1,839,830,405
Accumulated deficit
(1,834,847,961)
(1,815,165,163)
Accumulated other comprehensive loss
(636,093)
(637,963)
Total Inovio Pharmaceuticals, Inc. stockholders’ equity
6,067,882
24,096,276
Total liabilities and stockholders’ equity
$49,777,142
$74,310,035























Inovio Pharmaceuticals, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended March 31,
2026
2025
Revenues:
Revenue from collaborative arrangement
$—
$65,343
Operating expenses:
Research and development
14,070,107
16,090,902
General and administrative
7,879,886
9,024,970
Total operating expenses
21,949,993
25,115,872
Loss from operations
(21,949,993)
(25,050,529)
Other income (expense):
Interest income
439,593
808,077
Change in fair value of common stock warrant liabilities
4,137,703
3,712,872
(Loss) gain on investment in affiliated entity
(2,103,688)
695,131
Net unrealized gain on available-for-sale equity securities
79,077
140,234
Other expense, net
(285,490)
(482)
Net loss
$(19,682,798)
$(19,694,697)
Net loss per share
Basic and diluted
$(0.28)
$(0.51)
Weighted average number of common shares used to compute net loss per share
Basic and diluted
69,101,910
38,613,653

FAQ

How did INOVIO (INO) perform financially in Q1 2026?

INOVIO reported a net loss of $19.7 million, or $0.28 per share, for Q1 2026. Total operating expenses declined to $21.9 million from $25.1 million a year earlier as both research and administrative costs were reduced.

What is the status of INOVIO’s INO-3107 BLA with the FDA?

INO-3107’s Biologics License Application is under active FDA review in the accelerated approval program, with a target PDUFA date of October 30, 2026. The FDA has completed its mid-cycle review and plans an informal meeting to discuss accelerated-approval eligibility.

How long does INOVIO (INO) expect its cash to last after Q1 2026?

INOVIO expects its cash, cash equivalents and short-term investments to fund operations into the first quarter of 2027. This guidance includes $16.0 million in April 2026 equity offering proceeds and an estimated $18 million operational cash burn for Q2 2026.

What were INOVIO’s operating expenses in Q1 2026 versus 2025?

Total operating expenses fell to $21.9 million in Q1 2026 from $25.1 million in Q1 2025. Research and development dropped to $14.1 million, while general and administrative expenses decreased to $7.9 million, reflecting tighter cost control.

What strategic pipeline moves did INOVIO highlight in this update?

INOVIO emphasized progress on INO-3107 for recurrent respiratory papillomatosis, including commercial readiness planning. It also announced a clinical trial collaboration with Akeso Inc. to test INO-5412 plus cadonilimab for glioblastoma in the Phase 2 INSIGhT platform trial.

How much cash and investments did INOVIO hold at March 31, 2026?

As of March 31, 2026, INOVIO held $37.7 million in cash, cash equivalents and short-term investments. This compares with $58.5 million at December 31, 2025 and excludes the $16.0 million of net proceeds raised in an April 2026 public equity offering.

Filing Exhibits & Attachments

4 documents