Immunitybio Inc 8-K Filings

ImmunityBio, Inc. reports that the Emirates Drug Establishment in the United Arab Emirates has granted Marketing Authorization for ANKTIVA across two indications: BCG-unresponsive non-muscle invasive bladder cancer (including carcinoma in situ and papillary-only disease) and metastatic non-small cell lung cancer after progression on checkpoint inhibitor–based therapy.

The bladder cancer authorization, described as the first worldwide to span the full spectrum of BCG-unresponsive disease, is supported by QUILT-3.032, where ANKTIVA plus BCG produced a 71% complete response rate in the CIS cohort (N=100) and a 12-month disease-free survival rate of 58.2% in papillary-only patients (N=80); Grade 3 treatment-related adverse events occurred in 1% of patients, with no Grade 4 or 5 events reported. The lung cancer indication is backed by QUILT-3.055, showing median overall survival of 14.6 months in checkpoint-refractory advanced NSCLC (N=79) and 16.2 months in patients achieving higher absolute lymphocyte counts. With this decision, ANKTIVA is now authorized in 34 countries, including the UAE, United States, United Kingdom, Saudi Arabia and the European Union.

ImmunityBio, Inc. reported results of its 2026 Annual Meeting of Stockholders held on June 9, 2026. Of 1,047,345,861 common shares outstanding as of April 13, 2026, 885,167,059 shares were represented, about 85% of eligible shares, establishing a quorum.

Stockholders re-elected nine directors, including Patrick Soon-Shiong, M.D., Cheryl L. Cohen, and seven other nominees, each to a one-year term ending at the 2027 annual meeting. Stockholders also ratified the appointment of Deloitte & Touche LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 882,420,139 votes in favor.

ImmunityBio, Inc. entered an exclusive development and supply agreement with Japan BCG Laboratory giving it sole rights to develop, import, sell, and distribute the Tokyo-172 strain of BCG for bladder cancer in the United States and its territories after potential FDA approval. JBL will manufacture and supply the product, while ImmunityBio leads all U.S. preclinical, clinical, regulatory, and commercialization activities, with no payments due before approval and a commitment to purchase at least two batches per year afterward. The Tokyo strain’s Phase III SWOG S1602 data showed non-inferiority to TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer, and this agreement complements ImmunityBio’s existing recombinant BCG partnership to help address chronic U.S. BCG shortages.

ImmunityBio, Inc. reported strong Q1 2026 growth driven by ANKTIVA, but a large accounting loss. Net product revenue reached about $44.2 million for the quarter, up ~168% versus Q1 2025 and 15% over Q4 2025, reflecting continued uptake of ANKTIVA.

GAAP net loss attributable to common stockholders widened to $632.8 million, largely from non-cash changes in the fair value of warrant and derivative liabilities and a related-party convertible note tied to a higher stock price, plus a write-off of a convertible note receivable and higher R&D and SG&A expenses. Adjusted net loss, which excludes these items, was $86.2 million.

Cash, cash equivalents and marketable securities increased to $380.9 million as of March 31, 2026, supported by $223.9 million of net cash provided by financing activities in the quarter. ANKTIVA is now approved or authorized across five regulatory jurisdictions covering about 34 countries, with expanding commercial availability, and a pivotal BCG-naïve NMIBC trial is fully enrolled with a supplemental BLA submission planned in 2026.

ImmunityBio, Inc. reported preliminary Q1 2026 net product revenue of approximately $44.2 million, driven by continued adoption of its bladder cancer therapy ANKTIVA. This represents about a 168% year-over-year increase versus Q1 2025 and a 15% sequential rise from $38.3 million in Q4 2025.

Full-year 2025 net product revenue was $113 million, up roughly 700% from 2024, underscoring rapid commercial ramp. The company ended Q1 2026 with about $380.9 million in cash, cash equivalents and marketable securities. ANKTIVA is approved or authorized in five regulatory jurisdictions covering roughly 34 countries, and key bladder cancer trials are fully enrolled with a supplemental BLA targeted in 2026.

ImmunityBio, Inc. filed a Form 8-K after submitting a comprehensive response to a Warning Letter from the FDA’s Office of Prescription Drug Promotion dated March 13, 2026. The letter concerned a podcast and a television advertisement related to ANKTIVA® promotional communications.

The company removed the cited podcast from its website and requested removal from third-party platforms, and stated the television advertisement was never broadcast. ImmunityBio describes immediate and planned corrective actions, including executive training, expanded Promotional Review Committee protocols, and use of external regulatory counsel, while reaffirming its commitment to accurate, balanced, and compliant advertising for ANKTIVA®.

ImmunityBio, Inc. amended its Revenue Interest Purchase Agreement, raising $75.0 million in additional non-dilutive financing in exchange for higher royalty-style payments on net sales in a defined global territory. The tiered revenue interest rate increased to 5.625%–12.50% of net sales, with future rate adjustments tied to whether cumulative payments reach $375.0 million by the end of 2029 and an overall cap at 195% of cumulative purchaser payments. Simultaneously, Nant Capital, an affiliate of the Executive Chairman, converted $25.0 million of a convertible promissory note into 4,606,596 common shares, reducing the note’s principal to $480.0 million. A related press release highlights that total committed capital under the royalty agreement has risen to $375 million and underscores recent global approvals for ANKTIVA®.

ImmunityBio reported full-year 2025 results highlighting explosive ANKTIVA growth alongside continued losses. Net product revenue from ANKTIVA reached $113 million, an approximately 700% year-over-year increase, with Q4 2025 net product revenue of $38.3 million and unit sales up about 750% versus 2024.

Regulatory approvals now cover BCG-unresponsive bladder cancer across four jurisdictions and 33 countries, and Saudi Arabia granted conditional accelerated approval for metastatic non-small cell lung cancer, with launch planned within 60 days of approval. Despite this momentum, the company posted a 2025 net loss attributable to common stockholders of $351.4 million, improved from $413.6 million in 2024, and ended the year with $242.8 million in cash, cash equivalents, and marketable securities against total liabilities of $1.0 billion.

ImmunityBio reported that the European Commission has granted conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept) plus BCG to treat adults with BCG‑unresponsive non‑muscle invasive bladder cancer carcinoma in situ, with or without papillary tumors.

This decision makes ANKTIVA the first immunotherapy authorized in Europe for this high‑risk bladder cancer setting and extends availability across all 27 EU member states plus Iceland, Norway, and Liechtenstein, bringing total country coverage to 33. Approval is based on the QUILT‑3.032 trial, which showed a 71% complete response rate, a median complete response duration of 26.6 months, and cystectomy‑free survival among responders of 96% at 12 months and 84% at 36 months.

The authorization is conditional and requires ImmunityBio to submit long‑term safety and efficacy data and renew the authorization annually, while the company pursues pricing, reimbursement, and patient access across Europe.

ImmunityBio, Inc. entered into a material definitive agreement by amending its existing convertible Second Amended and Restated Promissory Note with Nant Capital, LLC, which has an outstanding principal amount of $505.0 million.

The January 23, 2026 letter amendment changes the note to allow the holder, an entity affiliated with Executive Chairman Dr. Patrick Soon-Shiong, to convert any portion of the outstanding principal into fully paid and nonassessable shares of ImmunityBio common stock at any time before the note’s maturity date. Previously, the December 10, 2024 version of the note did not permit partial conversions.

The company confirms that no other terms of the convertible promissory note were changed by this amendment.

ImmunityBio, Inc. filed a current report to disclose that it issued a press release with certain preliminary, unaudited financial results for the fiscal quarter and full year ended December 31, 2025, along with other company updates. These figures are based on information available as of the press release date and are not a comprehensive statement of its operating results or financial position.

The company notes that final results to be reported in its Annual Report on Form 10-K for the year ended December 31, 2025 will follow normal financial closing procedures and may differ materially from the preliminary estimates. The press release is furnished, not filed, meaning it is not subject to certain Exchange Act liabilities and is not automatically incorporated into other securities filings unless specifically referenced.

ImmunityBio, Inc. reported that the Saudi Food and Drug Authority has granted accelerated approval for its immunotherapy ANKTIVA in two cancer indications. ANKTIVA was approved for use with immune checkpoint inhibitors to treat adult patients with metastatic non-small cell lung cancer whose disease has progressed after standard-of-care therapy. It was also approved in combination with BCG for adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary disease. The company disclosed these updates through press releases that are furnished as exhibits.

ImmunityBio, Inc. amended its existing Open Market Sale Agreement with Jefferies to expand its at-the-market stock offering program. The amendment authorizes the issuance of up to an additional $459,972,480 of common shares, which were registered under a new prospectus supplement dated December 23, 2025 and issued under the company’s effective Form S-3ASR shelf registration.

The company also highlighted that a previously approved Certificate of Amendment to its charter became effective on November 10, 2025, increasing authorized common shares from 1,350,000,000 to 1,650,000,000. Legal opinions and the amendment documents are filed as exhibits, supporting the validity of the newly registered shares and the updated ATM program.

ImmunityBio, Inc. appointed Bruce Wendel to its board of directors, effective December 12, 2025, with his term running until the 2026 annual meeting of stockholders. The board determined that he qualifies as an independent director under Nasdaq and SEC rules.

Wendel brings extensive pharmaceutical and biotech experience, including senior roles at ProMetic Biosciences, Hepalink USA, Scientific Protein Laboratories, Abraxis BioScience, Bristol-Myers Squibb, IVAX, and American Pharmaceutical Partners, as well as prior public company board service at GT BioPharma and Verastem.

As a non-employee director, he will receive $50,000 in annual cash compensation and an initial stock option grant under ImmunityBio’s 2025 Equity Incentive Plan with a Black-Scholes value of $300,000, vesting over three years and fully vesting immediately before a Change in Control, along with reimbursement of reasonable travel expenses.

ImmunityBio, Inc. furnished a press release announcing its financial results for the third quarter and nine months ended September 30, 2025, and its financial position as of September 30, 2025.

The press release, dated November 4, 2025, is included as Exhibit 99.1 to this Form 8-K. The information under Item 2.02 (including Exhibit 99.1) is being furnished, not filed, under the Exchange Act.

ImmunityBio reported a federal court's preliminary approval of a proposed settlement to resolve several stockholder derivative lawsuits brought nominally on behalf of the company. Under the Stipulation, the company will adopt specified corporate governance reforms and will pay attorneys' fees in exchange for a full and complete release and dismissal of the derivative claims. The company states it expects those attorneys' fees will be funded by its insurance carrier. The court has set a final approval hearing for November 4, 2025. The company has posted the Notice and the Stipulation to its Investor Relations website and attached them as Exhibits 99.1 and 99.2.

ImmunityBio (IBRX) filed an 8-K disclosing a capital raise. On 24 Jul 2025 the company executed a Securities Purchase Agreement to sell 29,629,632 common shares together with five-year warrants for an equal number of shares. Each share-and-warrant unit is priced at $2.70, while the warrants carry a $3.24 exercise price and become immediately exercisable. Gross proceeds are expected to be about $80 million before fees and expenses; closing is targeted for 28 Jul 2025 subject to customary conditions.

Piper Sandler & Co. will act as exclusive placement agent under a separate agreement and will receive a cash fee equal to 6.0 % of gross proceeds (no fee on warrant exercises). The securities are being issued from the company’s effective shelf registration statement on Form S-3ASR.

The 8-K also references two press releases dated 25 Jul 2025: (i) a business update with preliminary, unaudited Q2 results and regulatory developments, and (ii) an announcement of the registered direct offering. Full financial figures were not included in the filing; exhibits provide the SPA, warrant form, placement agency agreement, legal opinion and related consents.

ImmunityBio, Inc. (NASDAQ: IBRX) filed an 8-K to report the results of its 2025 Annual Meeting held on 18 June 2025 and the adoption of a new share-based compensation program.

Equity Incentive Plan: Stockholders approved the 2025 Equity Incentive Plan, which immediately replaces the 2015 plan scheduled to expire in July 2025. The new plan reserves 46,088,027 new shares of common stock and allows recycling of up to 32,359,674 shares from previously granted but forfeited or expired awards under the 2015 plan. In total, up to roughly 78 million shares (≈ 8.8 % of shares outstanding) could be issued over time, subject to customary anti-dilution adjustments.

Governance Matters: • A strong quorum was achieved with 785,427,063 shares (≈ 89 % of outstanding) represented.
• All eight incumbent directors—including Executive Chairman Patrick Soon-Shiong, M.D.—were re-elected. “For” votes ranged from 695.2 million to 700.9 million, with minimal opposition and 81.7 million broker non-votes.
• The 2025 Equity Incentive Plan garnered 684.0 million votes “For” (≈ 96 % of votes cast, excluding broker non-votes).
• Deloitte & Touche LLP was ratified as auditor for fiscal 2025 with 781.3 million votes “For” (≈ 99 %).

Strategic Rationale: The Board states the new plan is intended to enhance ImmunityBio’s ability to attract, retain, and motivate key talent by providing equity-based incentives that align employee and shareholder interests. No additional awards will be granted under the 2015 plan, but existing awards will continue to be governed by it.

No financial performance metrics, earnings data, or major transactions were disclosed in this filing. The only exhibit filed is the full text of the 2025 Equity Incentive Plan (Exhibit 10.1).