Inovio Pharmaceuticals, Inc. Class Action Lawsuit – INO

Introduction to Inovio Pharmaceuticals, Inc. (INO) Securities Class Action Lawsuit

A federal securities class action has been filed against Inovio Pharmaceuticals, Inc. (NASDAQ: INO), alleging violations of the Securities Exchange Act of 1934, including Sections 10(b) and 20(a) covering October 10, 2023 through December 26, 2025. Investors allege the company misrepresented the readiness of its CELLECTRA device, the timing of its INO-3107 Biologics License Application (BLA), and the drug's regulatory path, including the accelerated approval pathway of the U.S. Food and Drug Administration. During the period, Inovio repeatedly pointed to an accelerated approval route and a second-half 2024 BLA submission. The truth surfaced when the company disclosed a CELLECTRA manufacturing issue that pushed the filing into 2025 and later revealed the FDA had accepted the BLA, placing it on the standard review timeline and flagged inadequate information for accelerated approval. On these disclosures, Inovio's stock (NASDAQ: INO) fell on August 9, 2024 and again on December 29, 2025, harming investors.

“Most INO shareholders never file or join the class action, which means they miss out on potential recovery funds,” said Attorney Joseph Levi.

Inovio Pharmaceuticals, Inc. (INO) Securities Lawsuit Case Details

Case Name: Carlson v. Inovio Pharmaceuticals, Inc. et al.

Case No.: 2:26-cv-00803

Jurisdiction: U.S. District Court, Eastern District of Pennsylvania

Filed on: February 6, 2026

Inovio Pharmaceuticals, Inc. (INO) Company Profile

Inovio is a biotechnology company, publicly traded on the NASDAQ exchange developing DNA-based medicines for diseases associated with human papillomavirus (HPV) and other HPV-associated diseases. Its medicines use DNA plasmids and the company's proprietary investigational device, CELLECTRA electroporation device, to help deliver those plasmids into cells; the lead candidate is INO-3107 for recurrent respiratory papillomatosis (RRP), a rare condition.

Inovio Pharmaceuticals, Inc. (INO) Securities Lawsuit Class Period

October 10, 2023-December 26, 2025, inclusive.

All persons and entities other than Defendants that purchased or otherwise acquired Inovio securities, including common stock during the Class Period may be eligible to join the Inovio Pharmaceuticals, Inc. (INO) class action lawsuit.

Allegations in the Inovio Pharmaceuticals, Inc. (INO) Securities Class Action Lawsuit

According to the complaint, Inovio Pharmaceuticals, Inc., its President, Chief Executive Officer, and Director Jacqueline E. Shea, and its Chief Financial Officer Peter Kies are sued for statements about INO-3107's regulatory path and the company's device manufacturing, including alleged manufacturing deficiencies in the CELLECTRA device. The case centers on what they told investors about regulatory prospects and a near-term BLA submission, including use of the accelerated approval pathway and projected regulatory approval timing.

The story begins on October 10, 2023, when Inovio issued a press release stating it had received FDA feedback that data from the completed Phase 1/2 trial of INO-3107 "could support" a BLA under the accelerated approval program of the U.S. Food and Drug Administration. That same day, CEO Jacqueline Shea said the company would "focus[] on streamlining our development plan to support submission of a BLA for accelerated approval." As the narrative continued into the new year, on January 3, 2024, Shea told investors that, based on productive FDA discussions, Inovio believed it had "established a path" to submit a BLA under accelerated approval. Then on May 13, 2024, Inovio reiterated in another press release that it "remains on target to submit its BLA seeking accelerated approval for INO-3107 in the second half of 2024."

Meanwhile, the complaint alleges a different reality. Manufacturing for the CELLECTRA device was deficient, including a component deficiency, making a second-half 2024 BLA submission unlikely. The company also lacked sufficient information to justify accelerated approval or priority review, overstating INO-3107's regulatory and commercial prospects, under FDA standards for accelerated approval. As a result, investors allege these public statements were materially false and misleading, and maintained artificial stock price inflation during the class period.

The Truth Emerges

The first break came on August 8, 2024, when Inovio disclosed in a press release and earnings call that it now expected to submit the INO-3107 BLA in mid-2025, approximately a one-year delay in the regulatory timeline, because of "a manufacturing issue" with the single-use disposable administration component of CELLECTRA, part of the CELLECTRA delivery system. CEO Jacqueline Shea acknowledged, "we've recently identified a manufacturing issue ... that we believe is resolvable, but will take additional time to rectify."

The second reveal landed on December 29, 2025, when Inovio announced the FDA had accepted the INO-3107 BLA for standard review (not accelerated approval). The company quoted the agency's file acceptance letter for the Biologics License Application noting a potential review issue: the FDA's preliminary conclusion that Inovio "has not submitted adequate information to justify eligibility for the accelerated approval pathway." These disclosures directly undercut prior assurances about both timing and accelerated approval prospects, placing INO-3107 on the standard review timeline.

Market Reaction

Investors reacted as the disclosures hit. Following the August 8, 2024 announcement, Inovio's stock (NASDAQ: INO) fell $0.27, or 3.1%, to close at $8.44 on August 9, 2024, reflecting a disclosure-driven decline. After the December 29, 2025 news that the FDA had accepted the BLA for standard review and flagged inadequate information for accelerated approval, the stock dropped $0.56, or 24.45%, to close at $1.73 that same day.

Next Steps

The Court will issue its order for lead plaintiff and counsel in the weeks after submissions are due.
The Court will then consider motion for class certification.
The Court will later consider a Motion to Dismiss.

Disclaimer: This shareholder alert is for informational purposes only and does not constitute legal advice. Consult a qualified attorney for personalized guidance. No specific outcomes are guaranteed.

Investigation History

(i) manufacturing for Inovio’s CELLECTRA device was deficient; (ii) accordingly, Inovio was unlikely to submit it's lead product candidate, INO-3107 BLA to the FDA by the second half of 2024; (iii) Inovio had insufficient information to justify the INO-3107 BLA’s eligibility for FDA accelerated approval or priority review; (iv) accordingly, INO-3107’s overall regulatory and commercial prospects were overstated; and (v) as a result, defendants’ public statements were materially false and misleading at all relevant times.

Frequently Asked Questions

What is the Inovio Pharmaceuticals securities class action lawsuit about?

The lawsuit alleges that Inovio Pharmaceuticals, Inc. (NASDAQ: INO) and certain executives made materially false and misleading statements between October 10, 2023, and December 26, 2025. According to the complaint, defendants overstated the prospects for FDA accelerated approval of INO-3107, the company's lead product candidate for treating recurrent respiratory papillomatosis (RRP). The lawsuit claims defendants failed to disclose manufacturing deficiencies with the CELLECTRA device and that the company lacked sufficient information to justify accelerated approval eligibility.

Who are the defendants named in the Inovio class action complaint?

The complaint names three defendants: Inovio Pharmaceuticals, Inc., the biotechnology company headquartered in Plymouth Meeting, Pennsylvania; Jacqueline E. Shea, who served as President, Chief Executive Officer, and Director during the relevant period; and Peter Kies, who served as Chief Financial Officer. The lawsuit alleges these individual defendants possessed the authority to control the company's SEC filings, press releases, and market communications, and knew or recklessly disregarded that material facts were being misrepresented.

What specific misrepresentations does the complaint allege Inovio made?

According to the complaint, defendants allegedly:

Overstated INO-3107's regulatory and commercial prospects for FDA accelerated approval
Failed to disclose manufacturing deficiencies with the CELLECTRA device component
Misrepresented the company's ability to submit the BLA by the second half of 2024
Did not reveal that Inovio had insufficient information to justify accelerated approval eligibility
Made generic risk disclosures that were not tailored to actual known risks

What were the stock drops associated with the alleged corrective disclosures?

The complaint identifies two significant stock price declines. On August 9, 2024, following disclosure of a manufacturing issue that delayed the BLA submission by approximately one year, Inovio's stock fell $0.27 per share (3.1%) to close at $8.44. On December 29, 2025, after the FDA accepted the BLA on a standard rather than accelerated review timeline, the stock fell $0.56 per share (24.45%) to close at $1.73 per share.

What is the class period for the Inovio securities lawsuit?

The class period spans from October 10, 2023, through December 26, 2025, inclusive. The lawsuit seeks to represent all persons and entities, other than the defendants, who purchased or otherwise acquired Inovio securities during this timeframe and were allegedly damaged by the defendants' violations of federal securities laws, specifically Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.

What legal claims are asserted in the Inovio complaint?

The complaint asserts two counts under federal securities laws. Count I alleges violations of Section 10(b) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 against all defendants for making materially false and misleading statements. Count II alleges violations of Section 20(a) of the Exchange Act against the individual defendants as "controlling persons" of Inovio who participated in the company's operations and allegedly caused the primary securities violations.

What securities offerings occurred during the alleged class period?

According to the complaint, Inovio conducted multiple securities offerings during the class period while allegedly disseminating misleading statements. These included an April 2024 offering yielding approximately $33.2 million in net proceeds, a December 2024 offering yielding approximately $27.6 million, a July 2025 offering yielding approximately $22.4 million, and a November 2025 offering yielding approximately $25 million in gross proceeds.

Where was the Inovio class action lawsuit filed?

The case was filed on February 6, 2026, in the United States District Court for the Eastern District of Pennsylvania. Venue is based on Inovio's headquarters being located in this district, with the company's principal executive offices at 660 West Germantown Pike, Suite 110, Plymouth Meeting, Pennsylvania. The plaintiff demands a jury trial and seeks damages for alleged violations of federal securities laws.

What is the Inovio Pharmaceuticals class action about?

The lawsuit alleges Inovio (NASDAQ: INO) and executives made false statements about INO-3107's FDA accelerated approval prospects between October 2023 and December 2025. The complaint claims defendants concealed manufacturing issues and insufficient data to support accelerated approval eligibility.

What stock drops are alleged in the Inovio lawsuit?

According to the complaint, Inovio stock fell 3.1% on August 9, 2024, after disclosing a manufacturing delay, and dropped 24.45% on December 29, 2025, when the FDA accepted the BLA on standard rather than accelerated review.

What is the class period for the Inovio case?

The class period runs from October 10, 2023, through December 26, 2025. The lawsuit covers investors who purchased Inovio securities during this timeframe and allegedly suffered damages from the defendants' conduct.

Who are the defendants in the Inovio securities lawsuit?

The complaint names Inovio Pharmaceuticals, Inc., CEO Jacqueline E. Shea, and CFO Peter Kies as defendants. The individual defendants allegedly controlled the company's public statements and SEC filings during the class period.

What legal claims does the Inovio complaint assert?

The lawsuit alleges violations of Section 10(b) and Rule 10b-5 of the Securities Exchange Act against all defendants, and Section 20(a) "controlling person" liability against the individual defendants.

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Step 2 of 3

Certification of Plaintiff Pursuant to Federal Securities Laws

I, duly certify and say, as to the claims asserted under the federal securities laws, that:

I have reviewed a complaint filed in the action.
I did not purchase the security that is the subject of this action at the direction of plaintiff's counsel or in order to participate in this action.
I am willing to serve as a representative party on behalf of the class, including providing testimony at deposition and trial, if necessary.
My transaction(s) in Inovio Pharmaceuticals, Inc. which are the subject of this litigation during the class period set forth in the complaint are set forth in the chart attached hereto.
Within the last 3 years,
I have not sought to serve nor have I served as a class representative in any federal securities fraud case. I have sought to serve as a class representative in
I will not accept any payment for serving as a representative party on behalf of the class beyond the Plaintiff's pro rata share of any recovery, except as ordered or approved by the court, including any award for reasonable costs and expenses (including lost wages) directly relating to the representation of the class.

Are you US Citizen?

Yes. I certify under penalty of perjury that the foregoing is true and correct. Executed this No. I certify under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed this

Clear

Signed pursuant to California Civil Code Section 1633.1, et seq. - and the Uniform Electronic Transactions Act as adopted by the various states and territories of the United States.

By your signature above, you confirm that have retained Levi & Korsinsky, LLP to represent you and the shareholder class as a lead plaintiff in the pending class action against Inovio Pharmaceuticals, Inc. This representation will be on a contingency basis, meaning that Levi & Korsinsky will advance all expenses in the litigation and will only seek compensation and/or reimbursement of expenses if the firm obtains a recovery. Regardless of the result, we will never ask you to directly pay for any attorneys’ fees, expenses, or costs. Should we obtain a favorable result, we may ask the court to award us compensation and reimbursement of expenses to be paid by the defendants or as a portion of any class recovery. In exchange for our representation, you agree to cooperate as our client by providing, for example, relevant documents and deposition testimony, if necessary. During the course of this litigation, we may employ and/or work with other law firms, experts, and third-parties to successfully prosecute this action. If you are not appointed as the lead plaintiff or Levi & Korsinsky is not appointed as lead counsel, we will notify you of such decision at which time this representation will end unless otherwise extended by you and the firm. We look forward to working with you towards a successful resolution of this action.

I have reviewed the complaint linked in paragraph 1