Colorectal Cancer, Hereditary Nonpolyposis, Type 1

Exact Sciences' approach in multi-cancer early detection (MCED) confirmed in first-ever, long-term, follow-up data from an MCED trial1-2 Surveillance, Epidemiology, and End Results (SEER) program analysis shows continued, long- term confidence in prognostic value of the Oncotype DX Breast Recurrence Score® 3 New modeling data show superior health outcomes in colorectal cancer screening with Cologuard® compared to blood-based tests, including lower mortality and more life-years gained4,5 MADISON, Wis., May 26, 2023 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, announced today that it will present 15 abstracts at the American Society of Clinical Oncology® (ASCO®) Annual Meeting 2023, June 2-6, in Chicago, Illinois. Presentations include new data confirming Exact Sciences' approach to multi-cancer early detection (MCED), real-world outcomes using the Oncotype DX Breast Recurrence Score®, and modeling comparisons between Cologuard® and potential blood-based screening tests for colorectal cancer.1-5 Long-term analyses from Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing (DETECT-A), the first large, prospective, interventional study to screen for multiple cancers with a blood-based MCED test, showed that all patients diagnosed and treated for Stage I or II cancers remain cancer-free more than four years later. Most detected cancers had no standard of care screening tests. Data also showed that half of all patients with a cancer detected were successfully treated and remain cancer free more than four years after their initial test.1-2 Earlier analyses showed that an MCED test more than doubled the number of screening-detected cancers compared to standard-of-care screening methods alone.6 These new, encouraging, long-term data outcomes in MCED-detected cancer survivors continue to provide important context for the advancements in the Exact Sciences MCED program. "These first-ever, long-term MCED follow-up data confirm Exact Sciences' approach to detecting multiple cancers at earlier stages of disease, and show that early detection enables successful treatment and long-term freedom from cancer in patients," said Tom Beer, MD, Chief Medical Officer, Multi-Cancer Early Detection, Exact Sciences. "A vast majority of cancers have no screening option today, and an accurate screening method, capable of detecting multiple cancers, is key to decreasing the number of cancer deaths. We look forward to advancing our MCED program with new data presentations at future medical meetings throughout the rest of the year." In addition, Exact Sciences will present a new, long-term Surveillance, Epidemiology, and End Results (SEER) analysis showing that the Oncotype DX Breast Recurrence Score® test is prognostic for breast cancer-specific mortality (BCSM) in patients with invasive ductal carcinoma (IDC) and invasive lobular breast cancer (ILC). In the 9-year analysis of nearly 10,000 patients with ILC and 65,000 patients with IDC, high Recurrence Score® (RS) results corresponded to high rates of chemotherapy use and BCSM risk. These correlations, which occurred regardless of whether the cancer had spread to lymph nodes, confirm the overall benefit of and confidence in the Oncotype DX Breast Recurrence Score test.3 These results build upon a previous study, confirming a clear and robust link between RS results and 5-year BCSM outcomes for patients with IDC and ILC. The Oncotype DX Breast Recurrence Score test is a prognostic genomic test designed to predict the likelihood of disease recurrence and chemotherapy benefit for patients with early-stage breast cancer, which Exact Sciences clinically validated in the TAILORx and RxPONDER trials. "These data continue to clearly show the proven and consistent value of our Oncotype DX Breast Recurrence Score test and its ability to detect a breast cancer patient's need for chemotherapy after surgery across various histologic sub-types," said Rick Baehner, MD, Chief Medical Officer, Precision Oncology, Exact Sciences. "This ASCO presentation offers reassurance to healthcare providers that the Recurrence Score provided to their ILC patients nine years earlier, continues to confidently inform treatment decisions." Exact Sciences will also share findings from modeling studies showing the positive impact of colorectal cancer screening with Cologuard® compared to a hypothetical blood-based test meeting CMS minimum performance thresholds. The studies provide insights into the overall lower costs of Cologuard compared to a blood based colorectal cancer blood test, as well as data showing higher life years gained when Cologuard is utilized compared to a potential blood-based test for colorectal cancer.4-5,7-10 Further data sets detail the results from a study estimating the undiagnosed cancer incidence in the U.S.15 , and additional studies with OncoExTra™, Oncotype DX Breast Recurrence Score, and Oncotype DX® Colon will also be presented.11-13 Data presentations across Exact Sciences' Screening and Precision Oncology portfolios at ASCO 20231-5, 7-16: Multi-Cancer Early Detection Abstract 3037/Poster Bd #235: Long-term clinical outcomes of cancers diagnosed following detection by a blood-based multi-cancer early detection (MCED) test Authors: Buchannan A, et al. Date/Time: Saturday, June 3, 8:00 a.m. - 11:00 a.m. CT Location: Hall A Key Findings: Half of all patients with an MCED-detected cancer (13/26) were successfully treated and cancer free over four years after their initial MCED test, and over half of the patients in remission (7) had cancers with no standard-of-care screening options available. All patients with Stage I or II cancers who were treated remain cancer-free. Abstract 3039/Poster Bd #237: Outcomes in participants with a false positive multi-cancer early detection (MCED) test: Results from >4 years follow-up from DETECT-A, the first large, prospective, interventional MCED study Authors: Lennon A, et al. Date/Time: Saturday, June 3, 8:00 a.m. - 11:00 a.m. CT Location: Hall A Key Findings: False positive signals from MCED were uncommon, affecting less than 1% of individuals tested. Imaging-based diagnostic evaluation accurately evaluated patients with a false positive and the incidence of cancer following a false-positive MCED test was <1% per year after a median follow-up time of 4.3 years, confirming the capacity of imaging-based work-up to reassure patients. Abstract 3040/Poster Bd #237: The detection of multiple cancer types with an extended set of methylation and protein markers Authors: Viatcheslav E, et al. Date/Time: Saturday, June 3, 8:00 a.m. - 11:00 a.m. CT Location: Hall A Key Findings: Results from this pilot study found high sensitivity levels for cancer detection with methylated DNA and protein markers, demonstrating the potential for developing a sensitive and specific MCED test by combining these markers. At 99% specificity, overall sensitivity for cancer detection with DNA methylation markers (MDM) was 68%. Detection sensitivity with proteins was 43%. The MDMs and proteins model (8 MDMs and 5 proteins) achieved 75% sensitivity at 99% specificity. Precision Oncology Abstract 554/Poster Bd #384: SEER analysis of 9-year breast cancer specific mortality (BCSM) in patients (pts) with invasive lobular breast cancer (ILC) assessed by the 21-gene Breast Recurrence Score assay Authors: Geyer C, et al. Date/Time: Saturday, June 3, 8:00 a.m. - 11:00 a.m. CT Location: Hall A Key Findings: Oncotype DX Breast Recurrence Score test results were significantly linked to chemotherapy use and BCSM outcomes, confirming the prognostic benefit and overall confidence in these recurrence scores for ILC. Abstract 515/Poster Bd #324: ECOG-ACRIN E2197: Comparison of HER2 gene expression by RT-PCR across all HER2 immunohistochemistry groups with recurrence analysis Authors: Badve S, et al. Date/Time: Sunday, June 4, 4:30 p.m. - 6:00 p.m. CT Location: Hall B1 Key Findings: After analyzing a wide range of HER2 gene expression levels using the Oncotype DX® assay in breast cancer patients, HER2 expression was found to be associated with recurrence risk. Abstract 3620/Poster Bd #320: Treatments and clinical outcomes in stage II colon cancer (CC) patients (pts) with 12-gene Oncotype DX Colon Recurrence Score assay-guided therapy: Real-world data Authors: Brenner B, et al. Date/Time: Monday, June 5, 8:00 a.m. - 11:00 a.m. CT Location: Hall A Key Findings: A real-world analysis of 938 patients with stage II, MMR-proficient colorectal cancer confirms the prognostic value of the Oncotype DX Colon Recurrence Score test. Abstract e16175 (E-pub): Genomic profiling of biliary tract carcinomas by their location Authors: Gatalica Z, et al. Date/Time: N/A Location: N/A Key Findings: Whole-exome and whole-transcriptome sequencing of biliary tract cancer samples found actionable alterations in 153 of 155 samples (98.7%). Some alterations were associated with location, indicating that appropriate therapies for biliary tract cancers may differ by location. Screening Abstract 10580/Poster Pd #213: Colorectal cancer screening with blood-based tests: Estimated impact of a 1-, 2-, or 3-year screening interval compared with annual FIT and triennial mt-sDNA strategies Authors: Lieberman D, et al. Date/Time: Saturday, June 3, 1:15 p.m. - 4:15 p.m. CT Location: Hall A Key Findings: As compared to Cologuard, blood-based tests have limitations that result in more colonoscopies per life year gained. When compared to real-world adherence for mt-sDNA and FIT, blood-based tests with 1- and 2-year intervals and perfect adherence had higher LYG with the tradeoff of a greater number of diagnostic colonoscopies. Abstract 10567/Poster Bd #200: The impact of extending CRC screening to the older population - results from CRC-AIM microsimulation model Authors: Ebner D, et al. Date/Time: Saturday, June 3, 1:15 p.m - 4:15 p.m. CT Location: Hall A Key Findings: Extending CRC screening to the older population with continued mt-sDNA (Cologuard) demonstrated the best health outcomes compared to other modalities, such as colonoscopy and FIT testing. The study shows that in colorectal cancer screening, mt-sDNA is superior to FIT or blood testing among the older population. Abstract 6642/Poster Bd #134: Estimated life-years gained and resultant cost savings from follow-up colonoscopy after a positive multi-target stool DNA (mt-sDNA) test for colorectal cancer screening in commercially insured and Medicare populations Authors: Ebner D, et al. Date/Time: Saturday, June 3, 1:15 p.m. - 4:15 p.m. CT Location: Hall A Key Findings: Follow-up colonoscopy after a positive mt-sDNA test is estimated to result in more life-years gained and reduced incidence and mortality compared to those without a follow-up colonoscopy. Additionally, a follow-up colonoscopy was estimated to be less expensive than opting for no follow-up colonoscopy. Abstract e22514 (E-pub): Patient-provider communication factors associated with mt-sDNA screening for colorectal cancer Authors: Zhu X, et al. Date/Time: N/A Location: N/A Key Findings: Adherence to mt-sDNA screening and intention to re-screen was high and strongly associated with frequent conversations with healthcare providers. Abstract e18911 (E-pub): Estimated value-based pricing for blood-based colorectal cancer screening test versus multi-target stool DNA test Authors: Kisiel J, et al. Date/Time: N/A Location: N/A Key Findings: Compared to annual, biannual, and triennial blood-based colorectal cancer screening tests, triennial mt-sDNA tests were estimated to be more effective at all intervals and 44% to 102% less costly. According to estimates, the maximum price of a blood-based test should not exceed $49 to be considered a cost-effective option compared to mt-sDNA. Abstract e13548 (E-pub): Validating the use of machine-learning cancer staging algorithms for Medicare cost analyses Authors: Smith R, et al. Date/Time: N/A Location: N/A Key Findings: The previously-developed machine learning algorithms closely predicted the treatment costs of non-small cell lung cancer and colon cancer, particularly for early stages, and may be useful for future modeling studies. Abstract 10634/Poster Bd #267: Correlation of unobserved incidence of cancer in earlier stages with the observed incidence Authors: Chhatwal J, et al. Date/Time: Saturday, June 3, 1:15 p.m. - 4:15 p.m. CT Location: Hall A Key Findings: This modeling study estimates that up to 70% of the eight most common stage I and II cancers may be undiagnosed. In addition, there is no available screening test for pancreatic, non-Hodgkin's lymphoma, head and neck, and urinary bladder cancers, of which 33%-66% of early-stage cases are undiagnosed. Abstract #e22508 (E-pub): A flexible quantitative framework to assess the potential contribution of early cancer detection to improved cancer survival. Authors: Yu M, et al. Date/Time: N/A Location: N/A Key Findings: Based on our target survival improvement of 20%, common trends emerged across 14 of the 15 cancer types: i) we observed that the bulk of survival improvement can be achieved by detecting most disease prior to stage IV; ii) the remaining survival improvement can be achieved by detecting most cancers just one stage earlier. The solution revealed that lung cancer as the one cancer type that required more aggressive earlier detection than others, an expected result given that lung cancer has both very high incidence and very poor survival. About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. NOTE: Oncotype, Oncotype DX, Oncotype DX Colon Recurrence Score, Oncotype DX Breast Recurrence Score, and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners. About Cologuard® The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated. The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit . Rx only. Forward-Looking Statements This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results; our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated benefits of our acquisitions, including estimated synergies and other financial impacts. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; our reliance upon certain suppliers, including suppliers that are the sole source of certain products; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition for our products and services; the effects of any judicial, executive or legislative action affecting us or the healthcare system; recommendations, guidelines and quality metrics issued by various organizations regarding cancer screening or our products and services; our ability to successfully develop new products and services and assess potential market opportunities; our ability to effectively enter into and utilize strategic partnerships and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; the results of our validation studies and clinical trials, including the risks that the results of future studies and trials may differ materially from the results of previously completed studies and trials; our ability to manage an international business and our expectations regarding our international expansion and opportunities; our ability to raise the capital necessary to support our operations or meet our payment obligations under our indebtedness; the potential effects of changing macroeconomic conditions, including the effects of inflation and interest rate and foreign currency exchange rate fluctuations and any such efforts to hedge such effects; our ability to efficiently and flexibly manage our business amid uncertainties related to the coronavirus ("COVID-19") pandemic; the possibility that the anticipated benefits from our business acquisitions will not be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of acquired businesses' operations or the divestiture of business operations will be greater than expected and the possibility that integration or divestiture efforts will disrupt our business and strain management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; our ability to retain and hire key personnel; and the impact of labor shortages, turnover, and labor cost increases. The risks included above are not exhaustive. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. References [1] Buchannan A, et al. Abstract #3037, ASCO 2023. [2] Lennon A, et al. Abstract #3039, ASCO 2023. [3] Geyer C, et al. Abstract #554, ASCO 2023. [4] Lieberman D, et al. Abstract #10580. ASCO 2023. [5] Ebner D, et al. Abstract #10567. ASCO 2023. [6] Lennon AM, et al. Feasibility of blood testing combined with PET-CT to screen for cancer and guide intervention. Science. 2020 Jul 3;369(6499):eabb9601. [7] Ebner D. et al. Abstract #6642. ASCO 2023. [8] Zhu X, et al. Abstract # e22514. ASCO 2023. [9] Kisiel J, et al. Abstract #e18911. ASCO 2023. [10] Smith R, et al. Abstract #e13548. ASCO 2023. [11] Badve S, et al. Abstract #515, ASCO 2023. [12] Brenner B, et al. Abstract #3620 ASCO 2023. [13] Gatalica Z, et al. Abstract #e16175. ASCO 2023. [14] Viatcheslav E K, et al. Abstract #3040. ASCO 2023. [15] Chhatwal J, et al. Abstract #10634. ASCO 2023. [16] Yu M, et al. Abstract #e22508 ASCO 2023. Contacts SOURCE EXACT SCIENCES CORP

The Phase 2b cancer vaccine trial will study a multiple vaccination approach called ‘Tri-Ad5’ that uses three ImmunityBio vaccines in combination with the company’s IL-15 superagonist N-803, to potentially reduce the risk of developing colorectal and other cancers in patients with hereditary Lynch syndrome. An estimated 1 in every 300 people may be carriers of a mutation in a gene associated with Lynch syndrome1. People with this syndrome are more likely to be diagnosed with cancer at a younger age and are at increased risk of developing multiple types of cancers during their lifetime. This is the first study to assess the ability of vaccines, delivered by an adenovirus vaccine platform, combined with an immune-enhancer, N-803, to target cancer-specific proteins and activate NK and T cells to prevent cancer, with the goal of enrolling 186 participants at 14 centers throughout the U.S. CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc, (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced the opening of a clinical trial to study its investigational Tri-Ad5 vaccine combination (Adenovirus 5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803, an immune-enhancer, for people with a hereditary condition known as Lynch syndrome. This Phase 2b trial (NCT05419011) sponsored by the National Cancer Institute, part of the National Institutes of Health, will study whether Tri-Ad5 in combination with N-803 works to prevent colorectal and other cancers in study participants. Each of the three vaccines in Tri-Ad5 targets different proteins associated with precancer and cancer cells. The vaccine combination is studying whether activation of dendritic cells and training the immune system to recognize those proteins will destroy the precancer cells before the cancer advances. N-803 is designed to enhance the effects of the vaccines by increasing proliferation and activation of natural killer (NK) and T cells, thereby increasing the potential for cancer prevention in study participants. “We are excited to partner with the NCI on this important cancer vaccine study to potentially prevent or delay the onset of cancer for people who carry the gene associated with Lynch syndrome,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “Lynch syndrome affects tens of thousands of people each year and the average age of cancer diagnosis for them is just 44. People known to have the gene for Lynch syndrome can be followed closely by their doctors with regular examinations and scans to watch for the development of cancer but, currently, there is no treatment that prevents the development of cancer in these patients. We hope to change that with this innovative study developed by the NCI.” Lynch syndrome is one of the most common hereditary cancer syndromes. Not only can people with Lynch syndrome develop colorectal cancer some 20 years before the average age of diagnosis for this cancer, they are also at an increased risk of developing multiple types of other cancers, including endometrial, stomach, ovarian, pancreas, ureter and renal pelvis, biliary tract, brain, and small intestinal cancers. Colorectal cancer is the second-deadliest cancer type in the U.S., and approximately 3% to 5% of the 153,000 cases of colorectal cancer annually are thought to be due to Lynch Syndrome, as are 2% to 3% of all cases of endometrial cancer.2 “The Tri-Ad5 vaccine trial will be the largest Lynch syndrome cancer prevention study done in the U.S.,” said Asad Umar, D.V.M., Ph.D., a senior advisor to the director for translational research in NCI’s Division of Cancer Prevention (DCP) and a scientific lead for the trial. To learn more about this study, please visit . For patients interested in enrolling in this study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the website: and/or NCIMO_referrals@mail.nih.gov. About ImmunityBio’s Tri-Ad5 Vaccines ImmunityBio’s Tri-Ad5 vaccines target three tumor-associated antigens: brachyury, carcinoembryonic antigen (CEA), and mucin-1 (MUC1). Pre-clinical studies have demonstrated Tri-Ad5 vaccines elicit cytotoxic T cell-mediated tumor cell death and the establishment of memory T cells, and thus may provide protection against the growth and metastasis of cancer. Tri-Ad5 vaccines utilize a second-generation replication-defective human adenovirus serotype 5 (Ad5) vector with viral genes deleted to allow for production of the antigen and a vigorous immune response, without generating a host response to the vector and with the ability to overcome previous adenovirus immunity in cancer patients. Notably, in a phase 1 NCI trial, Tri-Ad5 generated antigen-specific T cells to MUC1, CEA, and/or brachyury in all 10 patients with no evidence of antigenic competition. The safety of multiple ImmunityBio product candidates utilizing the Ad5 technology has been demonstrated in phase 1 and 2 clinical trials for cancers across multiple tumor types. About ImmunityBio ImmunityBio is a vertically-integrated, clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. N-803 (Anktiva™), ImmunityBio’s lead cytokine fusion protein, is a novel IL-15 superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). N-803 is currently under review by the FDA for this indication with a Prescription Drug User Fee Act (PDUFA) target date of May 23, 2023. The company has established GMP manufacturing capacity at scale with cutting-edge cell therapy manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R&D, clinical trial, and regulatory operations, and development teams. For more information, please visit: Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding the information and data to be provided by the clinical trial described herein, the potential effects of the Tri-Ad5 vaccine combination together with N-803, the potential use and efficacy of ImmunityBio’s product candidates for the prevention and/or treatment of cancer, clinical trial protocol design, enrollment, advancement and potential results, potential regulatory pathway for certain of ImmunityBio’s product candidates and target indications, data from the clinical trials for certain of ImmunityBio’s product candidates, potential implications to be drawn from clinical trials, potential commercialization of product candidates, and ImmunityBio’s product candidates as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, (ii) the risks and uncertainties associated with the regulatory submission, review and approval process, (iii) ImmunityBio’s ability to retain and hire key personnel, (iv) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (v) ImmunityBio’s ability to successfully commercialize its product candidates and uncertainties around regulatory reviews and approvals, (vi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its product candidates and future approved products, (vii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies, and (viii) the unknown future impact of the COVID-19 pandemic on certain clinical trials or their milestones and/or ImmunityBio’s business operations or operating expenses. 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 March 1, 2023, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at . 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. 1&2 American Society of Clinical Oncology (ASCO) Cancer.net