# EDGAR Filing Document

**Accession Number:** 0001326110
**File Stem:** 0001193125-26-142932
**Filing Date:** 2026-4
**Character Count:** 15482
**Document Hash:** 11cc551f6b2a6bb4eb44b446cda39f93
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-142932.hdr.sgml**: 20260406

**ACCESSION NUMBER**: 0001193125-26-142932

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20260406

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260406

**DATE AS OF CHANGE**: 20260406

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ImmunityBio, Inc.
- **CENTRAL INDEX KEY:** 0001326110
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 431979754
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37507
- **FILM NUMBER:** 26839604

**BUSINESS ADDRESS:**
- **STREET 1:** 3530 JOHN HOPKINS COURT
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121
- **BUSINESS PHONE:** (844) 696-5235

**MAIL ADDRESS:**
- **STREET 1:** 3530 JOHN HOPKINS COURT
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** NantKwest, Inc.
- **DATE OF NAME CHANGE:** 20150713

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Conkwest, Inc.
- **DATE OF NAME CHANGE:** 20140416

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ZelleRx Corp
- **DATE OF NAME CHANGE:** 20050504

?xml version='1.0' encoding='ASCII'? 8-K

### 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): April 6, 2026

## ImmunityBio, Inc.

#### (Exact name of registrant as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-37507** | **43-1979754** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

#### 3530 John Hopkins Court

#### San Diego, California 92121

#### (Address of principal executive offices, including zip code)

#### Registrant's telephone number, including area code: (844) 696-5235

#### Not Applicable

#### (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 (see General Instruction A.2. below):

☐ 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<br>Symbol(s)** | **Name of each exchange<br>on which registered** |
| Common Stock, par value $0.0001 per share | IBRX | The Nasdaq Global Select Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §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 Section13(a) of the Exchange Act. ☐

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---

| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.**  |

---

On April 6, 2026, ImmunityBio, Inc. (the "Company") issued a press release announcing it had submitted a comprehensive response to the Warning Letter issued by the U.S. Food and Drug Administration Office of Prescription Drug Promotion on March 13, 2026 and outlining the Company's immediate and planned corrective actions related thereto. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference.

The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.**  |

---

*(d)* *Exhibits*.

---

| | |
|:---|:---|
| **Exhibit**<br>**Number** | **Description of Exhibit** |
| 99.1\* | [Press Release dated April 6, 2026](d70606dex991.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

\* Furnished herewith.

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#### 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.

---

| | | |
|:---|:---|:---|
|  |  | **IMMUNITYBIO, INC.** |
|  |  | *Registrant* |
| Date: April 6, 2026 | By: | /s/ David C. Sachs |
|  |  | David C. Sachs |
|  |  | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**![LOGO](g70606g0406080032556.jpg)

**NEWS RELEASE** 

**ImmunityBio Addresses FDA Correspondence and Reaffirms Commitment to Advertising Compliance**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Company initiated a comprehensive review of promotional materials and is implementing enhanced advertising
compliance measures, including expanded promotional review protocols, executive training, and external regulatory oversight

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Company has removed the identified podcast from its corporate website and formally requested its removal
from all third-party hosting platforms

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Company confirmed that the television advertisement cited in the FDA correspondence was never broadcast, aired,
or disseminated to the public

**CULVER CITY, Calif., April 6, 2026** – ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced it has submitted a comprehensive response to the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) regarding issues raised on March 13, 2026 related to a television advertisement and a podcast. The company addressed the concerns related to the podcast and informed OPDP that the television advertisement was never aired.

The response outlines the company's immediate and planned corrective actions and its ongoing commitment to ensuring all promotional communications for ANKTIVA<sup>®</sup> (nogapendekin alfa inbakicept-pmln) are accurate, balanced, and compliant with FDA regulations.

**Commitment to Advertising Compliance and Resolution** 

ImmunityBio has taken proactive steps to address the OPDP's concerns, including the removal of the identified podcast from its corporate website and requesting its removal from third-party platforms. Additionally, the company confirmed that a television advertisement mentioned in the OPDP letter was never broadcast or disseminated to the public.

"ImmunityBio takes promotional compliance with the utmost seriousness," said Richard Adcock, President and CEO of ImmunityBio. "We are dedicated to maintaining a clear distinction between our investigational pipeline aspirations and the promoted indications for our approved therapies. We believe our substantive remedial actions and enhanced internal protocols address the Agency's concerns."

Upon receipt of the letter from OPDP, ImmunityBio initiated a comprehensive review of all promotional materials and external communications claims with its legal and regulatory teams.

The company is implementing a robust suite of corrective actions and compliance enhancements, including mandatory executive training, expanded Promotional Review Committee (PRC) protocols, and the engagement of external regulatory counsel to audit future high-visibility communications.

**Clarifying the Context of Scientific Innovation** 

In its response, ImmunityBio also provided background regarding the statements cited by the Office of Prescription Drug Promotion, which occurred during a podcast appearance by Founder and Executive Chairman Dr. Patrick Soon-Shiong. The company noted that these remarks were intended to convey Dr. Soon-Shiong's aspirational and forward-looking opinions regarding his vision for the company's drug development pipeline and the underlying science supporting the strategy of treating patients with cancer.

------

**Other key points of clarification include:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The characterization of the IL-15 molecule, the foundation of ANKTIVA, as
a highly promising agent was based on an independent assessment by the National Cancer Institute (NCI)during its Immunotherapy Agent Workshop dated July 12, 2007.<sup>1</sup>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The discussion focused on the investigational applications of the IL-15 platform across multiple oncology indications, where it is currently being studied under FDA-authorized investigational programs.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• References to "cancer vaccines" were intended to describe the mechanistic potential of
immunotherapies that induce memory T cells, a fundamental goal of the company's long-term research strategy, as stated in multiple scientific publications.<sup>2</sup>

**About ANKTIVA<sup>®</sup> (nogapendekin alfa inbakicept-pmln)** 

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA<sup>®</sup> overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA<sup>®</sup> is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA<sup>®</sup> mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

**IMPORTANT SAFETY INFORMATION** 

**INDICATION AND USAGE:** ANKTIVA<sup>®</sup> is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

**WARNINGS AND PRECAUTIONS:** Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA<sup>®</sup> with BCG, reconsider cystectomy.

**DOSAGE AND ADMINISTRATION:** For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA<sup>®</sup> at <u>Anktiva.com</u>.

**About ImmunityBio** 

ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient's immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield<sup>™</sup> platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and

------

memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit <u>ImmunityBio.com</u> and connect with us on <u>X</u> (Twitter), <u>Facebook</u>, <u>LinkedIn</u>, and <u>Instagram</u>.

**Forward Looking Statements** 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding our planned corrective actions and compliance enhancements. These statements are based on the Company's current expectations, beliefs, assumptions, and plans and involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the Company's ability to successfully execute on these corrective action and compliance enhancement plans and the reliance on the cooperation of third-parties for certain corrective actions. More details about these and other risks that may impact ImmunityBio's business are described under the heading "Risk Factors" in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at **<u>www.sec.gov</u>**.

ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

**ImmunityBio Contacts:** 

**Investors** 

**Hemanth Ramaprakash, PhD, MBA** 

**ImmunityBio, Inc.** 

+1 858-746-9289

<u>Hemanth.Ramaprakash@ImmunityBio.com</u>

**Media** 

**Sarah Singleton** 

**ImmunityBio, Inc.** 

+1 415-290-8045

<u>Sarah.Singleton@ImmunityBio.com</u>

References:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. Cheever, Martin A. Twelve immunotherapy drugs that could cure cancers. Immunological Reviews.
2008;222(1):357–368. doi:10.1111/j.1600-065X.2008.00604.x.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. Kartikasari AER, Prakash MD, Cox M, Wilson K, Boer JC, Cauchi JA, Plebanski M. *Therapeutic Cancer Vaccines—T Cell Responses and Epigenetic Modulation*. Front Immunol. 2019 Jan 25;9:3109.