B-cell lymphoma recurrent

Company’s first clinical trial studying CAR-NK (CD19 t-haNK) cellular therapy in liquid tumors First natural killer cell-based cellular therapy study conducted in the continent of Africa Complete enrollment currently expected in Q1 2025 CULVER CITY, Calif.--(BUSINESS WIRE)--Immunotherapy innovator ImmunityBio, Inc. ( NASDAQ: IBRX ), announced today that the first patients have been dosed in an initial trial studying the potential of the company’s CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin’s lymphoma (NHL). In the QUILT 106 trial, CD19-targeted high-affinity natural killer (t-haNK) cells are being tested initially as a single agent, and after demonstrating safety, then in combination with standard NHL treatment rituximab, in participants with selected CD19+ and CD20+ relapsed/refractory B-cell NHL. The phase 1, open label clinical study is designed to enroll up to 10 participants and is being conducted in Johannesburg, Pretoria, and Bloemfontein, South Africa. This is the first cellular-targeted natural killer (NK) cell therapy study ever to be conducted in South Africa, and is designed to provide important clinical information on a cancer with a significant rate of diagnosis in the region, but with few treatment options. Non-Hodgkin’s lymphoma is the 6 th most common malignancy among people in Sub-Saharan Africa and it is the 4 th most diagnosed cancer in men and the 5 th most diagnosed cancer in women in South Africa, according to the Cancer Association of South Africa. “This trial is important for ImmunityBio as our first clinical study of our CAR-NK, CD19 t-haNK cell line, as well as one of our first studies in liquid tumors,” said Patrick Soon-Shiong, M.D., Executive Chairman, Founder and Global Chief Scientific and Medical Officer at ImmunityBio. “We have chosen to undertake this trial because Sub-Saharan African and, in particular, South African populations are often overlooked when it comes to advanced clinical research, despite the need for innovative immunotherapies in the region.” Full patient enrollment in this Phase 1 study of CD19 t-haNK is currently expected in the first quarter of calendar year 2025 with topline data readout expected in the second half of the calendar year 2025. This study, being conducted in South Africa, is similar to ImmunityBio’s U.S.-based trial QUILT 3.092, a phase 1 open-label study of CD19 t-haNK as a single agent and in combination with the company’s IL-15 superagonist (N-803; ANKTIVA®) and rituximab in participants with relapsed or refractory NHL. About the QUILT 106 Study The Phase 1, first-in-human (FIH), open-label study is designed to enroll up to 10 participants at sites in Johannesburg, Pretoria, and Bloemfontein, South Africa with the primary endpoint of the trial to evaluate the safety and preliminary efficacy of CAR-NK, CD19 t-haNK as a single agent and in combination with rituximab in participants with selected CD19+ and CD20+ R/R B-cell non-Hodgkin lymphoma (NHL). Participants will initially receive a single 3-week cycle of the CD19 t-haNK as a single-agent regime. Following a 1-week safety pause, participants will then receive a 3-week cycle of CD19 t-haNK in combination with rituximab. Patients will undergo multiple assessments of safety and efficacy to help evaluate the safety of CD19 t-haNK as a single agent and in combination with rituximab in participants with R/R NHL, who have active disease after completing ≥ 2 lines of cytotoxic chemotherapy. About CAR-NK, CD19 t-haNK CD19 t-haNK is a human, allogeneic, stable clonal NK cell line generated from the parental activated NK (aNK) cell line (NK-92). Based on the demonstrated therapeutic efficacy of chimeric antigen receptor (CAR) targeting and on the important role of FcγR-mediated antibody-dependent cellular cytotoxicity (ADCC) in the effectiveness of therapeutic IgG1 monoclonal antibodies, it was hypothesized that modification of the parental aNK cell line to stably express both a CD19-targeted CAR and the high-affinity variant of CD16 would result in potent and selective antitumor activity. Therefore, the novel CD19 t-haNK cells have been genetically engineered to stably express 3 main proteins: (1) a human CD19-targeted CAR; (2) the high-affinity variant of the human Fcγ receptor (FcγRIIIa/CD16a 158V) for enhanced ADCC; and (3) endoplasmic reticulum-retained version of human interleukin-2 (ERIL-2) for independent growth. Non-Hodgkin Lymphoma Non-Hodgkin lymphoma (NHL) is a heterogeneous disease that most commonly originates in B lymphocytes. In 2020, according to the South Africa National Cancer Registry ( SANCR 2020 ), it is estimated that 1 in 174 men and 1 in 288 women will develop NHL. According to Global Cancer Observatory ( Sung 2021 ), the incidence of NHL is 4.1% of all cancers. A comparative study of the distribution of NHL subtypes in South Africa reported that Southern Africa had a significantly lower proportion of low-grade B cell NHL (34.3%) and a higher proportion of high-grade B cell NHL (51.5%) compared to Western Europe (54.5% and 36.4%) and North America (56.1% and 34.3%) ( Perry 2015 ). About ImmunityBio ImmunityBio is a vertically-integrated 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. Designated an FDA Breakthrough Therapy, ANKTIVA ® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. 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. For more information, visit and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . 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 clinical trial plans and timing, patient enrollment and treatment, timing of data read outs, market and prevalence data, the regulatory review process and timing thereof, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this presentation 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,” “is,” “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) risks and uncertainties regarding clinical trial patient enrollment and timing and potential results, including with respect to the trial described herein, (ii) risks and uncertainties related to the regulatory submission and review process, (iii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (iv) whether clinical trials will result in registrational pathways and the risks and uncertainties regarding the regulatory submission, review and approval process, (v) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (vi) potential delays in product availability and regulatory approvals, (vii) ImmunityBio’s ability to retain and hire key personnel, (viii) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (ix) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (x) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies. 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 19, 2024 and the Company’s Form 10-Q filed with the SEC on August 12, 2024, 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. Contacts Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com Media Sarah Singleton ImmunityBio +1 415-290-8045 Sarah.Singleton@ImmunityBio.com

ZYNLONTA® net sales of $17.0 million in 2Q 2024; Commercial profitability achieved during first half of 2024 LOTIS-7 trial enrollment on track with efficacy and safety data on eligible patients expected by year-end 2024 and mature data on all patients expected in first half of 2025 Full enrollment in LOTIS-5 trial expected before year-end 2024 Company to host conference call today at 8:30 a.m. EDT LAUSANNE, Switzerland, Aug. 06, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today reported financial results for the second quarter ended June 30, 2024, and provided operational updates. “We continue to make progress on multiple fronts, including reaching a key milestone as ZYNLONTA achieves commercial profitability in the first half of the year. We are excited about the potential to further our growth as we move toward expanding into the second line setting of DLBCL and indolent lymphomas,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “Additionally, we have now passed futility analysis with LOTIS-5 and expect to complete enrollment this year, while also planning to deliver updates on the LOTIS-7 trial and on ADCT-601 targeting AXL. With our expected cash runway extended into mid-2026, we are well positioned to execute our strategy and advance multiple value-generating catalysts before year-end.” Second Quarter 2024 Operational Updates & Recent Highlights ZYNLONTA: Reached commercial profitability in the first half of 2024, generating net product sales of $17.0 million in the second quarter of 2024, a 5% decrease as compared to revenue of $17.8 million in the first quarter of 2024. Demand was impacted in part by variability in ordering patterns in the second quarter. LOTIS-7: During the second quarter, the Company announced the completion of dose escalation in LOTIS-7, a Phase 1b open-label clinical trial evaluating ZYNLONTA in combination with bispecific antibodies glofitamab or mosunetuzumab in heavily pre-treated patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). Enrollment in the Part 2 dose expansion is progressing and completion is expected by year-end. An update on safety and efficacy in evaluable patients is expected by year-end, with data on all patients anticipated in the first half of 2025. LOTIS-5: The Phase 3 confirmatory trial for ZYNLONTA in combination with rituximab in patients with 2L+ diffuse large B-cell lymphoma (DLBCL). An Independent Data Monitoring Committee (IDMC) conducted a prespecified interim analysis of unblinded data and has recommended that the trial continue as planned without modifications. Enrollment is nearing completion in the randomized portion of the trial with full enrollment expected before year-end 2024. Investigator-initiated trial in marginal zone lymphoma (MZL): Partial data from an investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA for the treatment of relapsed/refractory (r/r) MZL were presented on May 6, 2024 at the Lymphoma Research Foundation’s 2024 Marginal Zone Lymphoma Scientific Workshop by the trial’s lead investigator. Initial data from the first 15 evaluable patients showed 13 achieved a complete response and 1 achieved a partial response. The multi-center study is designed to enroll 50 patients. Additional data publications and presentations at medical congresses are expected in 2024 or 2025. Investigator-initiated trial in follicular lymphoma (FL): The investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab in patients with relapsed/refractory follicular lymphoma is currently being conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. Additional updates are expected at medical congresses in 2024 or 2025. ADCT-601 (targeting AXL): The Phase 1b trial in ADCT-601 targeting AXL continues enrolling patients in both the sarcoma and pancreatic cancer arms, optimizing dose and schedule. We plan to share an initial update from the Phase 1 trial in patients in the second half of 2024. Early-stage pipeline: Progress continues in the IND-enabling studies for the Company’s PSMA, NaPi2b and Claudin-6 targeting ADCs. ASCT2 targeting ADC is in drug candidate selection stage and is still on track to complete this year. The Company has selected one target to move forward toward IND which we expect to disclose in 2025. Second Quarter and First Half 2024 Financial Results Cash and cash equivalents: As of June 30, 2024, cash and cash equivalents were $300.1 million, compared to $278.6 million as of December 31, 2023. In May 2024 the Company completed an underwritten offering resulting in net proceeds of approximately $97.4 million, extending the expected cash runway into mid-2026. Product Revenues: Net product revenues were $17.0 million for the second quarter ended June 30, 2024 and $34.9 million for the first six months of 2024 as compared to $19.2 million and $38.2 million for the same periods in 2023. The quarter-over-quarter decrease is primarily due to lower sales volume, partially offset by a higher price. The year-to-date decrease is primarily due to lower sales volumes, as well as higher gross-to-net deductions primarily due to the discarded drug rebate accrual partially offset by a higher price. Research and Development (R&D) Expense: R&D expense was $24.3 million and $50.0 million for the three and six months ended June 30, 2024, respectively. This compares to R&D expense of $31.3 million and $69.7 million for the same periods in 2023. The decrease is due primarily to implementation of productivity initiatives and focused investment in prioritized development programs. Selling and Marketing (S&M) Expense: S&M expense was $10.7 million and $22.1 million for the three and six months ended June 30, 2024, respectively. This compares to S&M expense of $14.5 million and $29.8 million for the same periods in 2023. The decrease in S&M expense was primarily due to lower marketing and advertising costs and personnel related expenses. General & Administrative (G&A) Expense: G&A expense was $10.2 million and $22.3 million for the three and six months ended June 30, 2024, respectively. This compares to G&A expense of $12.0 million and $27.5 million for the same periods in 2023. The quarter-over-quarter decrease in G&A expense was primarily related to lower legal and audit fees, insurance and IT expenses while the year-to-date decrease was primarily related to lower insurance and IT expenses, partially offset by higher legal and audit fees. Net Loss: Net loss for the quarter ended June 30, 2024 was $36.5 million, or a net loss of $0.38 per basic and diluted share, as compared to net loss of $48.9 million, or a net loss of $0.60 per basic and diluted share for the same period in 2023. Net loss for the six months ended June 30, 2024 was $83.2 million, or a net loss of $0.93 per basic and diluted share, as compared to net loss of $108.3 million, or a net loss of $1.33 per basic and diluted share for the six months ended June 30, 2023. The decrease is primarily due to lower operating expenses. Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $24.4 million, or an adjusted net loss of $0.25 per basic and diluted share for the quarter ended June 30, 2024 as compared to adjusted net loss of $32.1 million, or $0.39 per basic and diluted share, for the same period in 2023. Adjusted net loss for the six months ended June 30, 2024 was $55.5 million, or an adjusted net loss of $0.62 per basic and diluted share, as compared to net loss of $73.9 million, or an adjusted net loss of $0.91 per basic and diluted share for the six months ended June 30, 2023. The decrease in adjusted net loss is primarily attributable to lower operating expenses. Conference Call Details ADC Therapeutics management will host a conference call and live audio webcast to discuss second quarter 2024 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under “Events & Presentations” in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call. About ZYNLONTA® ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com. ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on LinkedIn. ZYNLONTA® is a registered trademark of ADC Therapeutics SA. Use of Non-GAAP Financial Measures In addition to financial information prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP), this document also contains certain non-GAAP financial measures based on management’s view of performance including: Adjusted total operating expensesAdjusted net lossAdjusted net loss per share Management uses such measures internally when monitoring and evaluating our operational performance, generating future operating plans and making strategic decisions regarding the allocation of capital. We believe that these adjusted financial measures provide useful information to investors and others in understanding and evaluating our operating results in the same manner as our management and facilitate operating performance comparability across both past and future reporting periods. These non-GAAP measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with GAAP. When preparing these supplemental non-GAAP measures, management typically excludes certain GAAP items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these GAAP items to be normal, recurring cash operating expenses; however, these items may not meet the GAAP definition of unusual or non-recurring items. Since non-GAAP financial measures do not have standardized definitions and meanings, they may differ from the non-GAAP financial measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other GAAP financial measures. The following items are excluded from adjusted total operating expenses: Shared-Based Compensation Expense: We exclude share-based compensation expense from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation expense has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy. The following items are excluded from adjusted net loss and adjusted net loss per share: Shared-Based Compensation Expense: We exclude share-based compensation expense from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation expense has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy. Certain Other Items: We exclude certain other significant items that we believe do not represent the performance of our business, from our adjusted financial measures. Such items are evaluated by management on an individual basis based on both quantitative and qualitative aspects of their nature. While not all-inclusive, examples of certain other significant items excluded from our adjusted financial measures would be: changes in the fair value of warrant obligations and the effective interest expense associated with the senior secured term loan facility and the effective interest expense and cumulative catch-up adjustments associated with the deferred royalty obligation under the royalty purchase agreement with HealthCare Royalty Partners. See the attached Reconciliation of GAAP Measures to Non-GAAP Measures for explanations of the amounts excluded and included to arrive at the non-GAAP financial measures. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “would”, “expect”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “future”, “continue”, or “appear” or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the expected cash runway into mid-2026 the Company’s ability to grow ZYNLONTA® revenue in the United States; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company’s or its partners’ research and development projects or clinical trials including LOTIS 5 and 7, ADCT 601 and 602 as well as early research in certain solid tumors with different targets, linkers and payloads; the timing and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company’s products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company’s indebtedness, including Healthcare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company’s activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. ADC Therapeutics SACondensed Consolidated Statements of Operation (Unaudited)(in thousands, except for share and per share data) For the Three Months Ended June 30, For the Six Months Ended June 30, 2024 2023 2024 2023Revenue Product revenues, net $17,030 $19,197 $34,878 $38,150License revenues and royalties 380 86 585 125Total revenue, net 17,410 19,283 35,463 38,275Operating expense Cost of product sales (1,217) (1,132) (3,727) (1,105)Research and development (24,295) (31,342) (50,030) (69,717)Selling and marketing (10,701) (14,456) (22,091) (29,807)General and administrative (10,238) (12,002) (22,269) (27,505)Total operating expense (46,451) (58,932) (98,117) (128,134)Loss from operations (29,041) (39,649) (62,654) (89,859) Other income (expense) Interest income 3,253 2,372 6,201 4,547Interest expense (12,679) (10,309) (25,175) (20,600)Other, net 2,754 (5,067) 159 (4,234)Total other expense, net (6,672) (13,004) (18,815) (20,287)Loss before income taxes (35,713) (52,653) (81,469) (110,146)Income tax (expense) benefit (234) 4,498 (397) 3,980Loss before equity in net losses of joint venture (35,947) (48,155) (81,866) (106,166)Equity in net losses of joint venture (597) (767) (1,284) (2,130)Net loss $(36,544) $(48,922) $(83,150) $(108,296) Net loss per share Net loss per share, basic and diluted $(0.38) $(0.60) $(0.93) $(1.33)Weighted average shares outstanding, basic and diluted 95,691,245 81,471,127 89,121,783 81,140,287 ADC Therapeutics SACondensed Consolidated Balance Sheet (Unaudited)(in thousands) June 30, 2024 December 31, 2023ASSETS Current assets Cash and cash equivalents $300,119 $278,598Accounts receivable, net 22,868 25,182Inventory 15,191 16,177Prepaid expenses and other current assets 17,181 16,334Total current assets 355,359 336,291Non-current assets Property and equipment, net 5,483 5,622Operating lease right-of-use assets 9,685 10,511Interest in joint venture 260 1,647Other long-term assets 992 711Total assets $371,779 $354,782 LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities Accounts payable $10,708 $15,569Accrued expenses and other current liabilities 46,924 52,101Total current liabilities 57,632 67,670 Deferred royalty obligation, long-term 316,211 303,572Senior secured term loans 113,673 112,730Operating lease liabilities, long-term 9,309 10,180Other long-term liabilities 6,624 8,879Total liabilities 503,449 503,031 Total shareholders’ equity (deficit) (131,670) (148,249) Total liabilities and shareholders’ equity (deficit) $371,779 $354,782 ADC Therapeutics SA Reconciliation of GAAP Measures to Non-GAAP Measures (Unaudited)(in thousands, except for share and per share data) Three Months Ended June 30, Six Months Ended June 30,(in thousands)2024 2023 Change % Change 2024 2023 Change % ChangeTotal operating expense(46,451) (58,932) 12,481 (21)% $(98,117) $(128,134) $30,017 (23)%Adjustments: Share-based compensation expense (i)1,988 1,118 870 78% 2,146 9,192 (7,046) (77)%Adjusted total operating expenses(44,463) (57,814) 13,351 (23)% $(95,971) $(118,942) $22,971 (19)% Three Months Ended June 30, Six Months Ended June 30,in thousands (except for share and per share data)2024 2023 2024 2023Net loss$(36,544) $(48,922) $(83,150) $(108,296)Adjustments: Share-based compensation expense (i)1,988 1,118 2,146 9,192Deerfield warrants obligation, change in fair value (income) expense (ii)(2,230) (20) 838 (636)Effective interest expense on senior secured term loan facility (iii)4,413 4,480 8,816 9,020Deferred royalty obligation interest expense (iv)8,266 5,829 16,359 11,575Deferred royalty obligation cumulative catch-up adjustment (income) expense (iv)(263) 5,417 (526) 5,288Adjusted net loss$(24,370) $(32,098) $(55,517) $(73,857) Net loss per share, basic and diluted$(0.38) $(0.60) $(0.93) $(1.33)Adjustment to net loss per share, basic and diluted0.13 0.21 0.31 0.42Adjusted net loss per share, basic and diluted$(0.25) $(0.39) $(0.62) $(0.91)Weighted average shares outstanding, basic and diluted95,691,245 81,471,127 89,121,783 81,140,287 (i) Share-based compensation expense represents the cost of equity awards issued to our directors, management and employees. The fair value of awards is computed at the time the award is granted and is recognized over the requisite service period less actual forfeitures by a charge to the statement of operations and a corresponding increase in additional paid-in capital within equity. These accounting entries have no cash impact. (ii) Change in the fair value of the Deerfield warrant obligation results from the valuation at the end of each accounting period. There are several inputs to these valuations, but those most likely to result in significant changes to the valuations are changes in the value of the underlying instrument (i.e., changes in the price of our common shares) and changes in expected volatility in that price. These accounting entries have no cash impact. (iii) Effective interest expense on senior secured term loans relates to the increase in the value of our loans in accordance with the amortized cost method. (iv) Deferred royalty obligation interest expense relates to the accretion expense on our deferred royalty obligation pursuant to the royalty purchase agreement with HCR and cumulative catch-up adjustments related to changes in the expected payments to HCR based on a periodic assessment of our underlying revenue projections. CONTACTS: InvestorsMarcy GrahamADC TherapeuticsMarcy.Graham@adctherapeutics.com+1 650-667-6450Media:Nicole RileyADC TherapeuticsNicole.Riley@adctherapeutics.com+1 862-926-9040

Combination and monotherapy solid tumor dose escalation data for CLN-619 to be presented in a poster session at ASCO 2024 Annual Meeting CLN-978 development to focus exclusively on autoimmune diseases, starting with systemic lupus erythematosus (SLE) as the first indication Cash and investments of $434.8 million as of March 31, 2024, plus gross proceeds of $280 million from April private placement extends cash runway into 2028 Company appoints David Meek to its Board of Directors CAMBRIDGE, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reported recent and upcoming business highlights and announced its financial results for the first quarter ended March 31, 2024. “We have already made significant progress in the first quarter of 2024, continuing the momentum we demonstrated in 2023,” said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. “With our recently announced strategic expansion into immunology, we will develop our CD19xCD3 T cell engager (TCE), CLN-978, in autoimmune diseases starting with SLE as our first indication. We are further encouraged by recent clinical data validating the CD19-directed TCE approach, which is significantly differentiated from CAR T based approaches, while we actively evaluate additional autoimmune indications for CLN-978. We also remain keenly focused on advancing our deep pipeline of clinical-stage oncology programs, with multiple data catalysts through this year and early 2025. With the gross proceeds of $280 million from our recently completed private placement, we believe we are well positioned to execute on our near- and long-term strategic and operational objectives. Additionally, we are pleased to welcome David Meek as a new director to Cullinan’s Board. David brings notable experience in scaling organizations towards successful commercialization. Thomas Ebeling has decided to resign from the Board at the end of his term. We appreciate Thomas’s contributions to Cullinan from the inception of the company to the clinical-stage organization we are today.” Portfolio Highlights CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors and hematological malignancies Cullinan will present initial data from the combination dose escalation module, as well as an update on the monotherapy dose escalation, during a poster session at the 2024 ASCO Annual Meeting on June 1, 2024. Cullinan also remains on track to report initial data from disease specific dose expansion cohorts in the first half of 2025. CLN-978 (CD19xCD3 T cell engager): systemic lupus erythematosus In April 2024, Cullinan reported clinical observations from three patients treated in a Phase 1 dose escalation study of CLN-978 in relapsed / refractory B-cell non-Hodgkin lymphoma (B-NHL), which showed that CLN-978 is clinically active with a favorable safety pro the initial dose of 30 μg administered subcutaneously once weekly. Based on the potential of CLN-978 in autoimmune diseases, Cullinan has discontinued enrollment in the B-NHL study and will pursue development of CLN-978 in autoimmune diseases, with SLE as the initial indication. The Company plans to submit an IND application for SLE in the third quarter of 2024. Recent publications in Nature Medicine and the European Journal of Cancer provide clinical validation of the CD19xCD3 TCE approach across multiple autoimmune diseases. Cullinan is actively evaluating additional autoimmune indications for CLN-978 and is committed to assessing its broad potential. Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC Cullinan expects to complete enrollment in the pivotal Phase 2b portion of the REZILIENT1 study in patients with EGFR ex20ins NSCLC who have progressed after prior systemic therapy, with or without exon 20 targeted therapy, by year-end 2024. CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS Cullinan expects to provide a clinical data update from the ongoing Phase 1 multi-ascending dose study in r/r AML and MDS patients in the second half of 2024. CLN-418 (B7H4x4-1BB bispecific immune activator): Solid tumors Cullinan expects to provide a clinical data update from the ongoing Phase 1 dose escalation study in patients with advanced solid tumors in the second half of 2024. CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors. Corporate Updates David Meek has been appointed to the Board of Directors, effective May 15. Mr. Meek most recently served as CEO and board member of Mirati Therapeutics, Inc, and previously as CEO and board member of FerGene, Inc. and Ipsen. Thomas Ebeling will resign from Cullinan’s Board of Directors at the end of his term on June 26. In April, the Company announced its strategic expansion into autoimmune diseases and, with it, changed its name to Cullinan Therapeutics. Also in April, the Company completed an oversubscribed $280 million private placement sale of common stock. The financing includes new and existing leading life sciences institutional investors. In April, the Company announced the appointment of Mary Kay Fenton as Chief Financial Officer. First Quarter 2024 Financial Results Cash Position: Cash, cash equivalents, investments, and interest receivable were $434.8 million as of March 31, 2024. Combined with proceeds from the April 2024 private placement, Cullinan expects its cash resources to provide runway into 2028 based on its current operating plan. R&D Expenses: Research and development (R&D) expenses were $30.6 million for the first quarter of 2024, compared to $52.1 million for the first quarter of 2023. R&D expenses for both the first quarter of 2024 and 2023 included $3.1 million of equity-based compensation expenses. The decrease in R&D expenses was primarily related to the one-time upfront in-licensing fee for CLN-418 in 2023 and decreased chemistry, manufacturing and controls costs, partially offset by increased clinical costs. G&A Expenses: General and administrative (G&A) expenses were $12.3 million for the first quarter of 2024, compared to $10.7 million for the first quarter of 2023. G&A expenses in the first quarter of 2024 and 2023 included $5.1 million and $4.2 million of non-cash equity-based compensation expenses, respectively. The increase in G&A expenses was primarily driven by increases in personnel costs and non-cash equity-based compensation expenses, partially offset by decreases in legal fees. Net Loss: Net loss (before items attributable to noncontrolling interest) for the first quarter of 2024 was $37.3 million, compared with net loss of $58.1 million for the first quarter of 2023. Net losses resulted from the expenses described above, partially offset by interest income of $5.7 million and $4.5 million in the first quarter of 2024 and 2023, respectively. Shares Outstanding: As of May 8, 2024, Cullinan had 57,634,234 shares of common stock outstanding, plus pre-funded warrants outstanding that are convertible into 315,790 shares of common stock, and non-voting preferred stock outstanding that is convertible into 6,475,000 shares of common stock. About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune diseases. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about our Company at  and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our preclinical and clinical developments plans and timelines, the clinical and therapeutic potential of our product candidates, the strategy of our product candidates, our research and development activities, our cash runway and our plans regarding future data presentations. The words “believe,” “continue,” “expect,” “plan,” “potential,” “pursue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions, including the IND that we intend to CLN-978; the risk that any INDs we may not cleared by the United States Food and Drug Administration or are not cleared on our expected timelines, or at all; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Cullinan Therapeutics, Inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands) March 31, 2024 December 31, 2023 Cash, cash equivalents, investments, and interest receivable $ 434,827 $ 468,264 Total assets $ 449,430 $ 484,182 Total current liabilities $ 21,925 $ 28,137 Total liabilities $ 23,765 $ 30,287 Total stockholders’ equity $ 425,665 $ 453,895 Total liabilities and stockholders’ equity $ 449,430 $ 484,182 Cullinan Therapeutics, Inc. Consolidated Statements of Operations (unaudited) (in thousands, except per share amounts) Three Months Ended March 31, 2024 March 31, 2023 Operating expenses: Research and development $ 30,646 $ 52,096 General and administrative 12,343 10,660 Total operating expenses 42,989 62,756 Loss from operations (42,989 ) (62,756 ) Other income (expense): Interest income 5,693 4,508 Other income (expense), net (44 ) 107 Net loss (37,340 ) (58,141 ) Net loss attributable to noncontrolling interests (192 ) (179 ) Net loss attributable to common stockholders of Cullinan $ (37,148 ) $ (57,962 ) Net loss per share attributable to common stockholders of Cullinan: Basic and diluted $ (0.86 ) $ (1.42 ) Weighted-average shares used in computing net loss per share attributable to common stockholders of Cullinan: Basic and diluted 43,011 40,682 Contacts: Investors Chad Messer +1 203.464.8900 cmesser@cullinantx.com Media  Rose Weldon +1 215.801.7644 rweldon@cullinantx.com