ImmunityBio, Inc. (IBRX) — Company Research

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage immunotherapy company headquartered in San Diego, California, whose lead product ANKTIVA (nogapendekin alfa inbakicept-pmln) is an IL-15 receptor superagonist approved by the FDA in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors (per the FY2025 10-K, Item 1, filed 2026-02-23). For the year ended December 31, 2025 the Company reported total revenue of $113.3 million, up 668% year over year, with ANKTIVA net product revenue of $113.0 million up approximately 698% (per the FY2025 10-K, Item 7, filed 2026-02-23); an operating loss of -$256.0 million (per EDGAR XBRL OperatingIncomeLoss, 10-K period ending 2025-12-31); a net loss of -$351.4 million (per the FY2025 10-K, Item 7); and free cash flow of -$309.2 million (per yfinance annual cashflow, FY2025). The stock last traded at $7.22 against a 52-week range of $1.95 to $12.43 (per yfinance, pulled 2026-05-24), and the most recent earnings release was Q1 2026 on 2026-05-07, with the next (Q2 2026) date not disclosed in this report's source data. The Company employed 691 people as of 2025-12-31 (per the FY2025 10-K, Item 1, filed 2026-02-23).

1. Company Snapshot

Field	Value
Name	ImmunityBio, Inc. (per the FY2025 10-K, cover page, filed 2026-02-23)
Ticker / Exchange	IBRX / Nasdaq Global Select Market (per the FY2025 10-K, cover page)
Sector / Industry	Healthcare / Biotechnology (per yfinance, pulled 2026-05-24)
Market cap	$7.56bn (per yfinance, 2026-05-24)
Enterprise value	$8.31bn (per yfinance, 2026-05-24)
FY2025 revenue	$113.3M total; ANKTIVA net product revenue $113.0M (per the FY2025 10-K, Item 7, filed 2026-02-23)
FY2025 operating income (EDGAR XBRL)	-$256.0M (per EDGAR XBRL OperatingIncomeLoss, 10-K period ending 2025-12-31)
FY2025 free cash flow	-$309.2M (per yfinance annual cashflow, FY2025)
Gross margin (FY2025)	99.3% (cost of sales $0.8M on product revenue $113.0M, per the FY2025 10-K, Item 7)
Net margin (FY2025)	-310% (net loss -$351.4M on revenue $113.3M, per the FY2025 10-K, Item 7)
Employees	691 (per the FY2025 10-K, Item 1, Human Capital, as of 2025-12-31)
CEO	Richard Adcock, President & CEO (per the Q1 2026 earnings release, 2026-05-07; founder Patrick Soon-Shiong is Executive Chairman)
Headquarters	San Diego, California (per the FY2025 10-K, principal executive offices, filed 2026-02-23)
Website	immunitybio.com (per yfinance, pulled 2026-05-24)
Fiscal year-end	December 31 (per the FY2025 10-K, filed 2026-02-23)
Next earnings	Q2 2026 (Q1 2026 reported 2026-05-07 per yfinance earningsTimestamp; the next report date is not disclosed in this report's source data)
Dividend yield	None — ImmunityBio has never declared a dividend (per yfinance, pulled 2026-05-24; the FY2025 10-K)
52-week high	$12.43 (per yfinance, pulled 2026-05-24)
52-week low	$1.95 (per yfinance, pulled 2026-05-24)
Short interest	35.56% of float (per yfinance shortPercentOfFloat, pulled 2026-05-24)

2. Bull Case vs Bear Case

Bull Case

• ANKTIVA commercial ramp is steep and consistent. Per the FY2025 10-K (Item 7, filed 2026-02-23): ANKTIVA net product revenue reached $113.0 million in FY2025, an approximately 698% increase year over year, and total revenue rose 668% to $113.3 million. Per the Q1 2026 earnings release (2026-05-07): Q1 2026 net product revenue was $44.2 million, up approximately 168% year over year and up 15% sequentially from Q4 2025's $38.3 million, with net product revenue growth in every quarter since ANKTIVA's commercial launch in May 2024.
• Regulatory momentum is broadening the addressable label. Per the Q1 2026 earnings release (2026-05-07): the NCCN Clinical Practice Guidelines were updated to include ANKTIVA plus BCG for BCG-unresponsive NMIBC with papillary-only disease (Category 2A), in addition to CIS. Per ImmunityBio's announcement (2026-05-19): the FDA accepted a supplemental BLA for ANKTIVA plus BCG in BCG-unresponsive papillary-only NMIBC, with a PDUFA target action date of January 6, 2027.
• International approvals and a second indication are being secured. Per the Q1 2026 earnings release (2026-05-07): ANKTIVA is now approved or authorized across five regulatory jurisdictions representing approximately 34 countries, including the first approval in Asia by the Macau Special Administrative Region. Per the FY2025 10-K (Item 1, filed 2026-02-23): ANKTIVA received conditional approval from the Saudi SFDA in combination with a checkpoint inhibitor for metastatic NSCLC — described by the Company as the first regulatory approval for an IL-15 receptor superagonist in lung cancer.
• Strong gross margin on the approved product. Per the FY2025 10-K (Item 7, filed 2026-02-23): cost of sales was $0.8 million against product revenue of $113.0 million, a product gross margin of approximately 99.3% — a structurally high-margin profile once volume scales relative to fixed operating costs.
• Intellectual property and supply security are being reinforced. Per ImmunityBio's announcement (2026-05-18): five U.S. patents were issued covering the ANKTIVA-plus-BCG combination with terms extending through at least 2035. Per ImmunityBio's announcement (2026-05-16): the Company signed an exclusive U.S. agreement with Japan BCG Laboratory for the Tokyo strain of BCG, adding a second potential BCG source alongside its Serum Institute of India recombinant-BCG partnership to address the chronic U.S. BCG shortage.

Bear Case

• Deeply negative profitability and a going-concern warning. Per the FY2025 10-K (Item 7, filed 2026-02-23): operating loss was -$256.0 million (EDGAR XBRL OperatingIncomeLoss confirms -$256,027,000) and net loss was -$351.4 million in FY2025. The Company states: "we believe that substantial doubt exists regarding our ability to continue as a going concern without additional funding or financial support" (per the FY2025 10-K, Item 7).
• Accumulated deficit of $3.7 billion and persistent cash burn. Per the FY2025 10-K (Item 1A, filed 2026-02-23): "we have incurred significant losses each year, and, as of December 31, 2025, we had an accumulated deficit of $3.7 billion." Free cash flow was -$309.2 million in FY2025 (per yfinance annual cashflow, FY2025), and the accumulated deficit rose to $4.4 billion by 2026-03-31 (per the Q1 2026 earnings release, 2026-05-07).
• Severe historical dilution. Per the FY2025 10-K (balance sheet, filed 2026-02-23) and yfinance: shares outstanding grew from 421.6 million at FY2022 year-end to 1,011.8 million at FY2025 year-end, and stood at approximately 1,047.4 million as of 2026-05-24 (per yfinance) — roughly a 2.5x increase over three years to fund operations.
• Single-product, single-region revenue concentration. Per the FY2025 10-K (Item 1A, filed 2026-02-23): "We are substantially dependent on the successful commercialization of our approved product and the success and regulatory approval of our other product candidates." Per the FY2025 10-K (Item 7): four customers accounted for 42%, 19%, 18% and 17% of total revenue, respectively, and product revenue to date has been generated in the United States.
• Controlled-company governance and related-party financing. Per the FY2025 10-K (Item 1A, filed 2026-02-23): "Dr. Soon-Shiong, through his voting control of the company, has the ability to control actions that require stockholder approval." A $505.0 million December 2024 convertible promissory note is held by an entity affiliated with Dr. Soon-Shiong (carried at $477.1 million fair value at FY2025), and the Company also carries a $324.6 million revenue interest liability with Oberland (per the FY2025 10-K, Notes 13 and 14, filed 2026-02-23).

3. What Does ImmunityBio Actually Do?

ImmunityBio operates as a single commercial-stage immunotherapy business built around its Cancer BioShield platform, anchored by ANKTIVA (per the FY2025 10-K, Item 1, filed 2026-02-23). Substantially all of its revenue is ANKTIVA net product revenue.

Revenue line	FY2025	FY2024	YoY
Product revenue, net (ANKTIVA)	$112.982M	$14.150M	+698%
Other revenues	$0.306M	$0.595M	-49%
Total revenue	$113.288M	$14.745M	+668%

Source: the FY2025 10-K, Item 7, filed 2026-02-23.

In plain English, ANKTIVA is an antibody-cytokine fusion protein (an IL-15 receptor superagonist) that is instilled into the bladder together with BCG to stimulate natural killer (NK) cells, cytotoxic T cells and memory T cells — the body's own immune machinery — to clear bladder tumours without removing the bladder (per the FY2025 10-K, Item 1, filed 2026-02-23). The approved use is BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumours; commercial distribution began in May 2024 following FDA approval (per the FY2025 10-K, Item 1).

Geographically, product revenue to date has been earned in the United States, with international commercialisation beginning to contribute as ANKTIVA reaches five jurisdictions (~34 countries) including Saudi Arabia and Macau (per the Q1 2026 earnings release, 2026-05-07). A segment-level or geographic revenue breakdown beyond the product/other split above is not disclosed in this report's source data, as the Company reports as a single operating segment (per the FY2025 10-K, Item 7, filed 2026-02-23).

4. The Business Model

Per the FY2025 10-K (Item 1, filed 2026-02-23): ImmunityBio's model is to develop and commercialise next-generation immunotherapies that activate both the innate and adaptive immune systems. Today the revenue engine is a single approved biologic — ANKTIVA — sold in the United States to a concentrated set of specialty distributors and administered by urologists in combination with BCG. The economics are characteristic of a recently launched, high-gross-margin biologic: product gross margin was approximately 99.3% in FY2025 (cost of sales $0.8 million on product revenue $113.0 million, per the FY2025 10-K, Item 7), but the business is loss-making because research and development and selling, general and administrative spend vastly exceed gross profit.

The moat the Company describes rests on three pillars (per the FY2025 10-K, Item 1, filed 2026-02-23 and ImmunityBio's 2026-05-18 patent announcement): first, intellectual property — Dr. Soon-Shiong holds over 400 issued patents, and five U.S. patents covering the ANKTIVA-plus-BCG combination run through at least 2035; second, a proprietary IL-15 superagonist mechanism and an integrated manufacturing base (including a facility in Dunkirk, New York); and third, control of the BCG supply chain that ANKTIVA depends on, via partnerships with the Serum Institute of India (recombinant BCG) and Japan BCG Laboratory (Tokyo strain BCG).

A defining structural feature of the model is its reliance on related-party and structured financing rather than operating cash flow. Per the FY2025 10-K (Notes 13 and 14, filed 2026-02-23): the Company is funded in part by a $505.0 million convertible promissory note held by an entity affiliated with its Executive Chairman and by a revenue interest liability with Oberland under a Revenue Interest Purchase Agreement (RIPA), under which a percentage of ANKTIVA net sales in the covered territory is payable to Oberland.

5. Financial Health

5-year income trend (per the FY2025 10-K Item 7 and yfinance annual financials; FY2021 not in source data):

FY	Revenue	Operating income	Net income	Diluted EPS	Free cash flow
FY2025	$113.3M	-$256.0M (EDGAR XBRL)	-$351.4M	-$0.38	-$309.2M
FY2024	$14.7M	-$344.2M	-$413.6M	-$0.62	-$398.1M
FY2023	$0.6M	-$361.4M	-$583.2M	-$1.15	-$397.3M
FY2022	$0.2M	-$350.6M	-$416.6M	-$1.04	-$436.9M
FY2021	not disclosed in this report's source data	not disclosed in this report's source data	not disclosed in this report's source data	not disclosed in this report's source data	not disclosed in this report's source data

Per the FY2025 10-K (Item 7, filed 2026-02-23): the leap from $14.7 million of FY2024 revenue to $113.3 million in FY2025 reflects the first full year of ANKTIVA commercial sales. Operating loss narrowed from -$344.2 million to -$256.0 million as gross profit scaled, even though research and development plus selling, general and administrative expense remained the dominant cost base.

Balance sheet (per the FY2025 10-K, balance sheet, filed 2026-02-23 and yfinance annual balance sheet):

FY	Cash & equivalents	Total debt	Stockholders' equity (deficit)	Shares outstanding	Buybacks
FY2025	$88.3M (cash); $242.8M incl. marketable securities	$518.1M	-$500.5M	1,011.8M	$0
FY2024	$143.4M	$504.2M	-$489.1M	852.9M	$0
FY2023	$265.5M	$726.7M	-$587.0M	670.9M	$0
FY2022	$104.6M	$723.8M	-$447.3M	421.6M	$0

Per the FY2025 10-K (Notes 13 and 14, filed 2026-02-23): the principal debt instruments are the related-party convertible promissory note (carried at $477.1 million fair value at FY2025, up from $461.9 million at FY2024) and the Oberland revenue interest liability ($324.6 million at FY2025, up from $284.4 million at FY2024). The Company has a stockholders' deficit, so book equity is negative; the FY2025 retained-earnings (accumulated deficit) balance was -$3.73 billion.

Quarterly trend, last 5 quarters (per yfinance quarterly financials and the Q1 2026 earnings release, periods ending Q1 2025 through Q1 2026):

Quarter	Revenue	Gross profit	Operating income	Net income	Diluted EPS	Free cash flow
Q1 2026 (2026-03-31)	$44.2M	$44.0M	-$69.8M	-$632.8M	-$0.62	not disclosed in this report's source data (operating cash flow -$75.4M)
Q4 2025 (2025-12-31)	$38.3M	$37.9M	-$64.7M	-$61.9M	-$0.06	not disclosed in this report's source data
Q3 2025 (2025-09-30)	$32.1M	$31.9M	-$55.6M	-$67.3M	-$0.07	not disclosed in this report's source data
Q2 2025 (2025-06-30)	$26.4M	$26.3M	-$71.3M	-$92.6M	-$0.10	not disclosed in this report's source data
Q1 2025 (2025-03-31)	$16.5M	$16.5M	-$64.4M	-$129.6M	-$0.15	not disclosed in this report's source data

Revenue has risen every quarter since launch. The Q1 2026 net loss of -$632.8 million is far larger than the -$69.8 million operating loss because of a -$530.9 million non-cash change in the fair value of warrant and derivative liabilities and the related-party convertible note — driven by the significant increase in the Company's common-stock price during the quarter — plus a $7.4 million write-off of a convertible note receivable (per the Q1 2026 earnings release, 2026-05-07). On that basis the Company reported a non-GAAP adjusted net loss of -$86.2 million for Q1 2026 (per the Q1 2026 earnings release, 2026-05-07).

6. Valuation & Market Data

Raw market data only — no commentary on cheap or expensive.

Metric	Value
Share price	$7.22 (per yfinance, pulled 2026-05-24)
Previous close	$7.74 (per yfinance, pulled 2026-05-24)
Day range	$7.15 – $7.69 (per yfinance, pulled 2026-05-24)
52-week high / low	$12.43 / $1.95 (per yfinance, pulled 2026-05-24)
Market cap	$7.56bn (per yfinance, pulled 2026-05-24)
Enterprise value	$8.31bn (per yfinance, pulled 2026-05-24)
Shares outstanding	1,047.4M (per yfinance; 1,011,800,008 reported at 2025-12-31 in the FY2025 10-K)
Float	394.0M (per yfinance, pulled 2026-05-24)
Avg daily volume (10d)	15.10M (per yfinance averageVolume10days, pulled 2026-05-24)
Volume (latest)	17.94M (per yfinance, pulled 2026-05-24)
Beta	0.07 (per yfinance, pulled 2026-05-24)
Trailing P/E (GAAP)	not disclosed in this report's source data — net loss in TTM (per yfinance, pulled 2026-05-24)
Forward P/E	68.76 (per yfinance, pulled 2026-05-24)
P/S (TTM)	53.64 (per yfinance, pulled 2026-05-24)
P/B	-8.69 (negative — stockholders' deficit; per yfinance, pulled 2026-05-24)
EV / Revenue	58.92 (per yfinance, pulled 2026-05-24)
EV / EBITDA	-33.85 (per yfinance, pulled 2026-05-24)
P / FCF	not disclosed in this report's source data — FCF negative (per yfinance, pulled 2026-05-24)
Gross margin (TTM)	99.34% (per yfinance, pulled 2026-05-24)
Operating margin (TTM GAAP)	-157.88% (per yfinance, pulled 2026-05-24)
Net margin (TTM)	not meaningful — TTM net loss distorted by large non-cash fair-value charges (per yfinance, pulled 2026-05-24)
ROE	not disclosed in this report's source data — negative equity (per yfinance, pulled 2026-05-24)
ROA	-34.38% (per yfinance, pulled 2026-05-24)
Debt-to-equity	not disclosed in this report's source data — negative equity (per yfinance, pulled 2026-05-24)
Current ratio	6.67 (per yfinance, pulled 2026-05-24)
Dividend yield	None — Company has never paid a dividend (per yfinance, pulled 2026-05-24)
Short interest	35.56% of float (per yfinance shortPercentOfFloat, pulled 2026-05-24)
Put / call ratio	not disclosed in this report's source data

7. What Are They Building / What's Coming

Per the FY2025 10-K (Item 1, filed 2026-02-23), the Q1 2026 earnings release (2026-05-07) and named public announcements, ImmunityBio's near-term pipeline and initiatives include:

• BCG-unresponsive papillary-only NMIBC (sBLA under FDA review). Per ImmunityBio's announcement (2026-05-19): the FDA accepted a supplemental BLA for ANKTIVA plus BCG in BCG-unresponsive papillary-only NMIBC, with a PDUFA target action date of January 6, 2027 — potentially the first FDA-approved bladder-sparing option specifically for that population.
• BCG-naïve NMIBC (QUILT-2.005, sBLA planned 2026). Per the Q1 2026 earnings release (2026-05-07): the pivotal BCG-naïve CIS trial is fully enrolled, the Independent Data Monitoring Committee confirmed no additional enrollment is required, and a supplemental BLA submission is on track for 2026.
• Non-small cell lung cancer (NSCLC) + checkpoint inhibitor. Per ImmunityBio's announcement (2026-01-13): ANKTIVA plus CPI showed statistically significant immune restoration across two trials in 151 NSCLC patients, with responders in the later-line study (QUILT-3.055) showing longer median overall survival (16.2 vs 11.8 months; HR 0.52; p=0.0369). ANKTIVA is conditionally approved with CPIs for metastatic NSCLC in Saudi Arabia (per the FY2025 10-K, Item 1, filed 2026-02-23).
• Lymphopenia (tumour-agnostic) and cell-therapy programs. Per the FY2025 10-K (Item 1, filed 2026-02-23): the Company is pursuing ANKTIVA for chemotherapy/radiation-induced lymphopenia and is advancing NK-cell platforms, including PD-L1 t-haNK (a CAR-NK therapy that has received FDA RMAT designation) in indications such as glioblastoma, plus CD19-targeted therapies in non-Hodgkin lymphoma and Waldenström's macroglobulinemia (per the Q1 2026 earnings release, 2026-05-07).
• BCG supply security. Per ImmunityBio's announcement (2026-05-16): the exclusive U.S. agreement with Japan BCG Laboratory for the Tokyo strain of BCG, supported by the NCI-sponsored SWOG S1602 Phase III non-inferiority readout, positions the Company as sole U.S. BLA applicant for that strain, complementing its Serum Institute of India recombinant-BCG Expanded Access Program.

8. Competitive Landscape

ImmunityBio competes in non-muscle invasive bladder cancer against both clinical-stage developers and large-cap pharmaceutical companies. Peer comparison (per yfinance, pulled 2026-05-24; all figures in USD). ImmunityBio is the only company in the table with an FDA-approved, commercially marketed IL-15 immunotherapy for NMIBC; CG Oncology, enGene and Protara are clinical / early-commercial developers for which sales-based multiples are not meaningful.

Company	Ticker	Market cap	Revenue (TTM)	Gross margin	P/S
ImmunityBio, Inc.	IBRX	$7.56bn	$141.0M	99.34%	53.64
CG Oncology, Inc.	CGON	$5.67bn	$5.1M	not meaningful (clinical stage)	not meaningful
enGene Holdings Inc.	ENGN	$109.9M	not disclosed in this report's source data	not meaningful (clinical stage)	not meaningful
Protara Therapeutics, Inc.	TARA	$276.5M	not disclosed in this report's source data	not meaningful (clinical stage)	not meaningful
Merck & Co., Inc.	MRK	$302.33bn	$65.77bn	76.73%	4.60
Johnson & Johnson	JNJ	$564.11bn	$96.36bn	68.04%	5.85

Positioning, per public disclosures: CG Oncology (cretostimogene), enGene (detalimogene) and Protara (TARA-002) are advancing competing NMIBC candidates; Merck markets Keytruda in NMIBC; and Johnson & Johnson's TAR-200 is an intravesical competitor — the same comparator ImmunityBio used in its 2026-05-22 ISPOR health-economic analysis. The large-cap peers dwarf ImmunityBio in revenue and balance-sheet resources, while ImmunityBio's differentiation is being the first marketed IL-15 receptor superagonist with an approved bladder-cancer indication.

9. Leadership and Ownership

Per the FY2025 10-K (Item 1, filed 2026-02-23), the Q1 2026 earnings release (2026-05-07) and insider transaction filings via yfinance (pulled 2026-05-24): Patrick Soon-Shiong, M.D. is Founder, Executive Chairman and Global Chief Scientific and Medical Officer; he is a physician-scientist who holds over 400 issued patents and is the Company's controlling shareholder. Richard Adcock is President and Chief Executive Officer; David C. Sachs is Chief Financial Officer; Barry J. Simon, M.D. and Christobel E. Selecky serve as Directors. Detailed executive tenure and proxy-level biographical information beyond these roles is not disclosed in this report's source data (the Item 10 proxy section was not in the extracted 10-K text).

Top institutional shareholders as of 2026-03-31 (per yfinance institutional_holders, pulled 2026-05-24):

Holder	% held	Shares	Value (USD)
BlackRock Inc.	2.52%	26,346,443	$190.2M
State Street Corporation	1.69%	17,708,103	$127.9M
Vanguard Portfolio Management LLC	1.56%	16,322,844	$117.9M
Vanguard Capital Management LLC	1.44%	15,127,714	$109.2M
D. E. Shaw & Co., Inc.	1.20%	12,571,597	$90.8M
Geode Capital Management, LLC	0.77%	8,031,921	$58.0M
Two Sigma Investments, LP	0.42%	4,385,500	$31.7M
Morgan Stanley	0.38%	4,018,869	$29.0M
HRT Financial LP	0.37%	3,925,446	$28.3M
Woodline Partners LP	0.33%	3,447,346	$24.9M

Per yfinance (pulled 2026-05-24): institutional ownership totals 17.54% and insider ownership totals 62.48%, the latter reflecting Dr. Soon-Shiong's controlling stake. Recent insider activity (per insider_transactions via yfinance, pulled 2026-05-24):

• 2026-03-31: Dr. Patrick Soon-Shiong acquired 4,606,596 shares via conversion/exercise of a derivative security at $5.43 ($25.0 million).
• 2026-02-23 to 2026-02-24: Director Barry J. Simon sold a combined 250,000 shares at $9.25–$12.01 (approximately $2.68 million).
• 2026-02-23: Director Christobel E. Selecky sold 25,000 shares at $10.00 ($250,000) and converted 25,000 shares at $2.98.

10. Risks and Challenges

• Going concern / dependence on additional financing (Financial): Per the FY2025 10-K (Item 7, filed 2026-02-23): "we believe that substantial doubt exists regarding our ability to continue as a going concern without additional funding or financial support." The Company anticipates needing additional financing to fund operations, complete commercialisation and conduct clinical trials.
• History of losses and large accumulated deficit (Financial): Per the FY2025 10-K (Item 1A, filed 2026-02-23): "we have incurred significant losses each year, and, as of December 31, 2025, we had an accumulated deficit of $3.7 billion." FY2025 operating loss was -$256.0 million (EDGAR XBRL).
• Substantial dilution from equity issuance (Financial): Per the FY2025 10-K (Item 1A, filed 2026-02-23): additional equity or convertible issuance may "dilute the ownership interest of existing stockholders or may otherwise depress the price of our common stock." Shares outstanding rose from 421.6 million (FY2022) to 1,011.8 million (FY2025).
• Single-product, single-region revenue concentration (Concentration): Per the FY2025 10-K (Item 1A, filed 2026-02-23): "We are substantially dependent on the successful commercialization of our approved product and the success and regulatory approval of our other product candidates." Per the FY2025 10-K (Item 7): four customers accounted for 42%, 19%, 18% and 17% of total revenue.
• Dependence on BCG supply (Operational): Per the FY2025 10-K (Item 1, filed 2026-02-23): ANKTIVA is approved for use with BCG, and "currently TICE BCG is the only FDA-approved strain of BCG available in the U[S]" amid a chronic, decade-long U.S. BCG shortage — a direct constraint on ANKTIVA utilisation that the Serum Institute and Japan BCG Laboratory agreements are intended to mitigate.
• Controlled-company governance and related-party financing (Concentration): Per the FY2025 10-K (Item 1A, filed 2026-02-23): "Dr. Soon-Shiong, through his voting control of the company, has the ability to control actions that require stockholder approval," and he holds a controlling interest in affiliated entities that provide the Company's $505.0 million convertible note and lease its manufacturing facilities.
• Manufacturing and quality compliance (Operational): Per the FY2025 10-K (Item 1A, filed 2026-02-23): the Company is subject to obligations regarding its manufacturing facility in Dunkirk, New York, and manufacturers "must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP" — failure could materially impair supply.
• Promotional and regulatory compliance (Regulatory): Per the FY2025 10-K (Item 1A, filed 2026-02-23): the promotion and marketing of biologics is heavily regulated; ImmunityBio publicly responded to an FDA Office of Prescription Drug Promotion (OPDP) matter regarding ANKTIVA promotional materials in April 2026 (per ImmunityBio's 2026-04-06 statement), underscoring the compliance risk around marketing claims.
• Litigation and intellectual-property disputes (Competitive): Per the FY2025 10-K (Item 1A, filed 2026-02-23): the Company may be "subject to third-party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents," which could be costly and divert resources.
• Cybersecurity incidents (Cyber & Physical): Per the FY2025 10-K (Item 1C / Item 1A, filed 2026-02-23): the Company could "suffer a cyberattack, security breach or other incident," including compromise of confidentiality, integrity and availability of its systems, with potential material adverse effects.
• Clinical and regulatory approval risk for the pipeline (Regulatory): Per the FY2025 10-K (Item 1A, filed 2026-02-23): the Company's product candidates are investigational and there can be no assurance that label expansions (such as the papillary-only and BCG-naïve sBLAs) or new indications (such as NSCLC) will be approved by the FDA or other regulators.

11. Recent Developments

Most recent first.

• 2026-05-22 — ISPOR 2026 health-economic analysis published: ImmunityBio presented a health-economic analysis indicating ANKTIVA plus BCG delivered a lower cost per sustained complete responder than Johnson & Johnson's TAR-200 in BCG-unresponsive NMIBC CIS, with reported savings of up to ~$151,438 per cystectomy avoided over three years in a U.S. Medicare population. Source: ImmunityBio / Business Wire.
• 2026-05-19 — FDA accepts papillary-only sBLA; PDUFA January 6, 2027: The FDA accepted for review the supplemental BLA for ANKTIVA plus BCG in BCG-unresponsive papillary-only NMIBC (without CIS) and set a PDUFA target action date of January 6, 2027. Source: ImmunityBio.
• 2026-05-18 — Five U.S. patents issued for ANKTIVA + BCG: Five U.S. patents covering the ANKTIVA-plus-BCG combination were issued with terms extending through at least 2035, protecting the combination, dosing regimen and two-vial commercial kit. Source: ImmunityBio / Yahoo Finance.
• 2026-05-16 — Exclusive U.S. agreement with Japan BCG Laboratory (Tokyo strain): ImmunityBio signed an exclusive U.S. development and supply agreement for the Tokyo strain of BCG, supported by the NCI-sponsored SWOG S1602 Phase III non-inferiority readout, becoming sole U.S. BLA applicant for that strain; announced during Dr. Soon-Shiong's AUA 2026 presentation in Washington, DC. Source: ImmunityBio 8-K Exhibit 99.1.
• 2026-05-07 — Q1 2026 results: record revenue, large non-cash net loss: Q1 2026 net product revenue was $44.2 million (+168% YoY, +15% QoQ); cash, cash equivalents and marketable securities were $380.9 million; GAAP net loss was -$632.8 million (driven by a -$530.9 million non-cash fair-value remeasurement of warrants, derivatives and the related-party convertible note) and adjusted net loss was -$86.2 million. Source: ImmunityBio 8-K Exhibit 99.1.
• 2026-05-05 — Analyst action (reported factually): D. Boral Capital set a price target of $23.00 on IBRX (per analyst-action coverage). Reported here for completeness; ChartsView does not endorse this target. Source: public.com analyst forecast.

ImmunityBio's official X (Twitter) handle is @ImmunityBio and Executive Chairman Patrick Soon-Shiong posts as @DrPatSoonShiong; his public X commentary in the period centred on the U.S. BCG shortage and papillary bladder cancer ahead of AUA 2026, consistent with the 2026-05-16 Japan BCG Laboratory announcement above. No additional X posts with independently verifiable per-post links are included in this report's source data.

12. Key Dates Coming Up

• 2026-06-09 — 2026 Annual Meeting of Stockholders: Held virtually at 10:30 a.m. Pacific Time; Notice of Internet Availability mailed on or about 2026-04-30 (per the DEF 14A proxy statement filed 2026-04-29).
• 2026 (second half) — BCG-naïve NMIBC sBLA submission: A supplemental BLA submission for the BCG-naïve setting is on track for 2026, following full enrollment of QUILT-2.005 (per the Q1 2026 earnings release, 2026-05-07).
• 2027-01-06 — PDUFA target action date (papillary-only NMIBC sBLA): FDA decision target for ANKTIVA plus BCG in BCG-unresponsive papillary-only NMIBC (per ImmunityBio's 2026-05-19 announcement).
• Tokyo strain BCG — FDA engagement / BLA timing: ImmunityBio plans to engage the FDA on the regulatory pathway for the Tokyo strain of BCG; specific submission timing is not disclosed in this report's source data (per the 2026-05-16 Japan BCG Laboratory announcement).
• Q2 2026 earnings — date not disclosed in this report's source data: Q1 2026 was reported on 2026-05-07 (per yfinance earningsTimestamp); the Q2 release date has not been published in the source data used for this report.

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