中国江苏苏州、上海和美国加利福尼亚州圣迭戈, Feb. 22, 2024 (GLOBE NEWSWIRE) -- 亘喜生物科技集团（纳斯达克股票代码：GRCL；简称“亘喜生物” 或“公司”） 是一家面向全球、处于临床阶段的生物制药企业，致力于开发创新的细胞疗法以治疗癌症及自身免疫性疾病。今日，公司宣布正式完成了此前公告的与阿斯利康集团的合并协议。亘喜生物、AstraZeneca Treasury Limited（“母公司”）和Grey Wolf Merger Sub（“合并子公司”）依照其在2023年12月23日签订的相关协议和合并计划（“《合并协议》”）中的条款和条件完成了此次合并。AstraZeneca Treasury Limited 是一家根据英格兰和威尔士法律成立的私人有限公司。合并子公司是一家根据开曼群岛法律注册成立的豁免有限责任公司，也是母公司的全资子公司。此次合并中，合并子公司与亘喜生物进行合并, 亘喜生物作为存续公司成为母公司的全资子公司 (“合并”)。合并完成后，亘喜生物不再是一家上市公司，而成为母公司的全资子公司。 《合并协议》于2024年2月19日举行的特别股东大会上获得了公司股东的批 ...

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (("Gracell" or the "Company", NASDAQ:GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that at an extraordinary general meeting of shareholders (the "EGM") held on February 19, 2024, the Company's shareholders voted in favor of the proposal to approve ...

中国江苏苏州、上海和美国加利福尼亚州圣迭戈, Feb. 20, 2024 (GLOBE NEWSWIRE) -- 亘喜生物科技集团（纳斯达克股票代码：GRCL；简称“亘喜生物” 或“公司”） 是一家面向全球、处于临床阶段的生物制药企业，致力于开发创新、高效的细胞疗法以治疗癌症及自身免疫性疾病。公司宣布在2024年2月19日召开的特别股东大会(“EGM”)上，经公司股东投票表决，通过了一项批准并授权公司正式执行、交付并履行此前于2023年12月23日(“合并协议”)宣布的拟议并购协议的提案。该并购协议须由AstraZeneca Treasury Limited，一家根据英格兰和威尔士法律成立的私人有限公司(“母公司”)，以及根据开曼群岛法律注册成立的豁免有限责任公司、母公司全资子公司Grey Wolf Merger Sub(“合并附属公司”）向开曼群岛公司注册处提交合并计划(“合并计划”)，以及合并协议中所述的其他协议或文件，或与合并协议相关的任何文件或文书(“交易文件”)；双方合并协议中所述的可预期的交易（包括合并）的完成，以及合并协议附件B中所示的或有价值权益协议（统称为“交易”)，均受其中所列条件的约束。 ...

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (("Gracell" or the "Company", NASDAQ:GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared Gracell's Investigational New Drug (IND) application, allowing the Company to initiate a Phase 1 clinica ...

Financial Data and Key Metrics Changes - As of September 30, 2023, the company had RMB1,707.9 million or US$234.1 million in cash and cash equivalents and short-term investments, with an expected cash use of approximately US$100 million for the year primarily for R&D and clinical programs in the U.S. and China [26][22] - The net loss attributable to ordinary shareholders for the three months ended September 30, 2023, was RMB67.6 million or US$9.3 million, a decrease from RMB171.9 million in the prior year period, primarily due to a decrease in the fair value of warrant liabilities [27] - Research and development expenses for the same period were RMB90.1 million or US$12.3 million, down from RMB133.4 million in the prior year, attributed to decreased spending on research and clinical trials [27] Business Line Data and Key Metrics Changes - The company initiated patient dosing in its first U.S. trial for the BCMA-CD19 dual targeting FasTCAR GC012F in relapsed refractory multiple myeloma, with one clinical site currently recruiting patients and plans to activate additional sites [9] - In China, patient enrollment for the Phase 1/2 IND study in relapsed refractory multiple myeloma is expected to commence this quarter, following the receipt of all required approvals [10] - Clinical data from an ongoing Phase 1 IIT evaluating GC012F as a frontline treatment for high-risk newly diagnosed multiple myeloma showed a 100% overall response rate and 100% minimal residual disease-negative stringent complete response rate among 19 patients [24] Market Data and Key Metrics Changes - The company is expanding its CAR-T therapy applications beyond hematological cancers to address unmet needs in autoimmune diseases and solid tumors, indicating a strategic shift in market focus [8] - The company is also advancing its SMART CART technology for solid tumors, with preclinical data presented showing enhanced efficacy compared to conventional CAR-T [20] Company Strategy and Development Direction - The company aims to push the boundaries of cancer treatment through innovative CAR-T therapies, focusing on rapid manufacturing, safety, and durable responses [7] - The strategic pipeline alignment has led to the suspension of the Phase 2 trial for GC007g due to limited commercial opportunity, allowing the company to concentrate resources on potentially best-in-class programs [21] - The company plans to submit IND filings in the U.S. and China for the planned Phase 1 clinical trial in refractory systemic lupus erythematosus (rSLE) this year [19][75] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of GC012F, highlighting its favorable safety profile with no neurotoxicity observed in 60 patients treated [11] - The company anticipates releasing the first public readout from the ongoing IIT in SLE in the first half of 2024, with expectations of double-digit patient evaluations [18] - Management emphasized the importance of safety in CAR-T therapies as the company explores applications in autoimmune conditions, where safety standards are particularly high [12] Other Important Information - The company completed a private placement transaction in August 2023, raising $100 million upfront and up to $50 million in additional funds, extending its cash runway into the second half of 2026 [22] - The company is actively engaging in conversations with potential partners interested in both oncology and immunology [66] Q&A Session Summary Question: Can you provide more color on the percent of antibody secreting cells that may be CD19 negative? - Management acknowledged that while the exact percentage of CD19 negative ASC is not well-documented, it is known that such cells exist and are BCMA positive [31] Question: Can you quantify the B-cell antibody suppression seen with the dual construct versus CD19 CAR-T alone? - Management indicated that the dual construct showed more than a 10-fold increase in B-cell antibody suppression compared to the CD19 single CAR-T [33] Question: What type of data is the company planning to release in the first half of '24 for the SLE study? - Management expects to present data from double-digit patients, with most having at least three months of follow-up [45] Question: What is the regulatory path for the newly diagnosed multiple myeloma study? - Management stated that it is too early to define the study design for newly diagnosed patients but emphasized the importance of safety and efficacy in discussions with the FDA [41] Question: What is the expected duration of B-cell depletion in SLE patients? - Management noted that the duration of B-cell depletion is similar to that seen in multiple myeloma, but more time is needed to draw definitive conclusions [48] Question: Will there be additional translational work presented at the upcoming summit? - Management indicated that the data presented at the summit will be similar to what has already been shared, with no significant new information expected [68]

Table of Contents Exhibit 99.1 GRACELL BIOTECHNOLOGIES INC. INDEX TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS | Unaudited Interim Condensed Consolidated Financial Statements | PAGES | | --- | --- | | Unaudited Interim Condensed Consolidated Balance Sheets as of December 31, 2022 and June 30, 2023 | F-2 | | Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss for the Six Months Ended | | | June 30, 2022 and 2023 | F-3 | | Unaudited Interim Condensed Consolidated ...

Gracell Biotechnologies Inc. (NASDAQ:GRCL) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants William Cao - Chairman, Chief Executive Officer Wendy Li - Chief Medical Officer Kevin Xie - Chief Financial Officer Conference Call Participants Kelly Shi - Jefferies Joe Cantanzaro - Piper Sadler Justin Zelin - BTIG Emily Bodnar - Wainwright Yigal Nochomovitz - Citigroup Operator Ladies and gentlemen, thank you for standing by. My name is Bhavesh, and I’ll be your conference operator ...

Gracell Biotechnologies Inc. (NASDAQ:GRCL) Q1 2023 Earnings Conference Call May 15, 2023 8:00 AM ET Company Participants William Cao - Chairman, Chief Executive Officer Wendy Li - Chief Medical Officer Kevin Xie - Chief Financial Officer Conference Call Participants Yigal Nochomovitz - Citi Emily Bodnar - HC Wainwright Joe Cantanzaro - Piper Sandler Dave - Jefferies Wayne Wu - Cantor Fitzgerald Yanan Zhu - Wells Fargo Operator Ladies and gentlemen, thank you for standing by and welcome to the Gracell Biotec ...

Corporate Structure and Regulatory Compliance - Gracell Biotechnologies Inc. operates primarily through its subsidiaries in the U.S., Hong Kong, and China, with a significant portion of its operations conducted via a variable interest entity (VIE) structure[21]. - As of the date of the annual report, Gracell believes its corporate structure complies with current PRC laws, but uncertainties remain regarding future regulatory interpretations[26]. - The PRC government imposes controls on the convertibility of RMB into foreign currencies, which may restrict Gracell's ability to pay dividends in foreign currencies[34]. - The Holding Foreign Companies Accountable Act (HFCAA) could impact Gracell's ability to trade on U.S. exchanges if audit reports are not issued by PCAOB-inspected firms for two consecutive years[28]. - Gracell has not received any inquiries or sanctions regarding its corporate structure from PRC authorities as of the report date[26]. - Gracell's ability to enforce contractual arrangements with the VIE may be limited if PRC authorities determine these arrangements do not comply with regulations[32]. Financial Position and Performance - The total current assets amounted to RMB 1,885,080, with cash and cash equivalents at RMB 1,829,006, representing a significant liquidity position[42]. - Total liabilities were reported at RMB 232,766, with current liabilities comprising RMB 155,123, indicating a manageable short-term financial obligation[43]. - Shareholders' equity totaled RMB 1,827,371, reflecting a strong capital base despite accumulated deficits in subsidiaries and VIEs[43]. - The company has a cash and cash equivalents increase from RMB 1,454,645 to RMB 1,829,006 year-over-year, indicating improved liquidity[44]. - The total assets increased to RMB 2,060,137, showing growth in the company's asset base[42]. - The company reported a significant deficit in VIEs amounting to RMB 403,639, which could impact future financial performance[43]. - The accumulated deficit across various segments totaled RMB 1,017,772, indicating areas that may require strategic focus for recovery[43]. - The company incurred significant losses in every year since inception and expects to continue incurring losses over the next several years[58]. - The company has incurred net losses of RMB607.5 million (US$88.1 million) for the year ended December 31, 2022, with an accumulated deficit of RMB1,625.3 million (US$235.6 million) since inception[73]. - The company expects to continue incurring significant operating losses and negative cash flows over the next several years, as it has not generated any revenue from commercial sales of its product candidates[73]. Revenue and Expenses - Total revenues for the year ended December 31, 2022, were RMB 16,597 million, with intercompany eliminations resulting in no net revenue reported[47]. - Research and development expenses for the year ended December 31, 2022, totaled RMB 485,388 million, reflecting a significant investment in innovation[47]. - The net loss attributable to Gracell Biotechnologies Inc.'s ordinary shareholders for the year ended December 31, 2022, was RMB 607,509 million, indicating ongoing financial challenges[47]. - Total comprehensive loss attributable to Gracell Biotechnologies Inc.'s ordinary shareholders for the year ended December 31, 2022, was RMB 476,045 million, highlighting the impact of foreign currency translation adjustments[47]. - The company reported a loss from operations of RMB 624,658 million for the year ended December 31, 2022, underscoring operational difficulties[47]. - Interest income for the year ended December 31, 2022, was RMB 23,917 million, reflecting some financial returns despite overall losses[47]. - The equity in losses of subsidiaries and VIEs for the year ended December 31, 2022, amounted to RMB 1,271,601 million, indicating significant challenges in subsidiary performance[47]. - Administrative expenses for the year ended December 31, 2022, were RMB 139,270 million, contributing to the overall financial strain[47]. Funding and Capital Requirements - The company will need to obtain additional funding to complete the development and commercialization of its product candidates[58]. - The company expects significant additional capital may be needed in the future to continue planned operations, including clinical trials and commercialization efforts[83]. - If additional capital is raised through equity or convertible debt securities, existing shareholders may experience dilution of ownership interest[84]. - The company has received total net proceeds of approximately US$220.2 million from its initial public offering in 2021[80]. - The company plans to continue its research and development activities, including preclinical studies and clinical trials for its product candidates, which will require substantial additional funding[74]. Product Development and Regulatory Risks - The company has no products approved for commercial sale and may never achieve profitability, which could adversely affect the market price of its ADSs[76]. - The company relies on regulatory approvals for its product candidates, which are subject to significant uncertainty and may delay commercialization[62]. - All product candidates are in early stages of development, with no assurance of successful advancement through clinical trials or obtaining regulatory approvals[86]. - Biopharmaceutical development is a long and uncertain process, with potential delays or failures at any stage of clinical trials[88]. - The company faces risks related to the genetic modification of patient cells, including potential adverse effects and regulatory challenges[92]. - Public perception and awareness of cell therapy safety issues may influence participation in clinical trials and adoption by physicians[93]. - The company is focusing on developing next-generation CAR-T cell therapies targeting hematological cancers, with clinical-stage candidates including GC012F for r/r MM, NDMM, and B-NHL, GC502 for B-cell malignancies, and GC007g for B-ALL[103]. Manufacturing and Supply Chain Challenges - The company has manufacturing facilities in Suzhou and Shanghai, which support preclinical and clinical development, but faces challenges in scaling up for commercial production[145]. - The company has entered into a Manufacturing Services Agreement with Lonza Houston, Inc. for clinical manufacturing in the U.S. and is considering establishing additional manufacturing sites[146]. - The complexity of manufacturing biologics poses risks that could delay or halt the supply of product candidates for clinical trials or approved patients[148]. - The proprietary technology platform FasTCAR significantly shortens the manufacturing time for autologous CAR-T cells from an industry norm of one to six weeks to next-day manufacturing[149]. - The company currently manufactures all product candidates for preclinical testing and clinical trials in China, which may increase risks related to quality and supply[157]. - The manufacturing process is subject to stringent regulatory standards, including compliance with cGMP requirements enforced by the FDA and NMPA[159]. Data Privacy and Security - The company must comply with various privacy and data security laws, and failure to do so could result in enforcement actions and fines[181]. - Regulatory changes in China regarding data protection may impose additional restrictions on the company's operations[184]. - The company anticipates ongoing changes in data privacy laws, which may lead to increased compliance costs and potential liabilities[191]. - The General Data Protection Regulation (GDPR) imposes fines up to €20 million or 4% of consolidated annual worldwide gross revenue for breaches[189]. - The California Consumer Privacy Act (CCPA) may increase compliance costs and potential liabilities due to expanded rights for California residents[188]. Market and Competitive Landscape - The addressable market for certain product candidates may be limited to patients who are ineligible for or have failed prior treatments, potentially resulting in smaller market projections[126]. - The ongoing investigator-initiated Phase 1 trial for GC007g is targeting patients with r/r B-ALL, which has a low incidence overall, potentially limiting the patient population[129]. - The company is facing high competition for individuals with experience in cell therapy, which may impact future financial performance and product commercialization efforts[171]. - The company may face challenges in managing growth, requiring additional personnel to support product development and commercialization efforts[170].

Gracell Biotechnologies Inc. (NASDAQ:GRCL) Q4 2022 Earnings Conference Call March 13, 2023 8:00 AM ET Company Participants Kevin Yili Xie - Chief Financial Officer William Wei Cao - Founder, Chairman, and Chief Executive Officer Wendy Li - Chief Medical Officer Conference Call Participants Carly Kenselaar - Citi James Shin - Wells Fargo Justin Zelin - BTIG Emily Bodnar - H.C. Wainwright Operator [Operator Instructions] I would now like to turn the call over to Dr. Kevin Xie, CFO. Please go ahead. Kevin Yili ...