Caribou Biosciences Reports First Quarter 2024 Financial Results And Provides Business Update
Caribou Biosciences Reports First Quarter 2024 Financial Results And Provides Business Update
-- Advancing CB-010 ANTLER Phase 1 trial in 2L LBCL; initial dose expansion data to be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting --
— 推進 2L LBCL 的 CB-010 ANTLER 1 期試驗;初始劑量擴展數據將在 2024 年美國臨床腫瘤學會 (ASCO) 年會上公佈 —
-- Expanding into autoimmune diseases with IND cleared for CB-010 in lupus nephritis and extrarenal lupus; GALLOP Phase 1 clinical trial expected to initiate by YE 2024 --
— 擴展到自身免疫性疾病,狼瘡腎炎和腎外狼瘡的 CB-010 臨床試驗已獲批准;GALLOP 1 期臨床試驗預計將於 2024 年啓動 —
-- Advancing four clinical-stage programs for hematologic malignancies and autoimmune diseases; multiple milestones ahead --
— 推進血液系統惡性腫瘤和自身免疫性疾病的四項臨床階段項目;未來將有多個里程碑——
-- $345.9 million in cash, cash equivalents, and marketable securities expected to fund the current operating plan into Q1 2026 --
-- 3.459億美元的現金、現金等價物和有價證券預計將爲2026年第一季度的當前運營計劃提供資金 --
BERKELEY, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported financial results for the first quarter 2024 and reviewed recent pipeline progress.
加利福尼亞州伯克利,2024年5月7日(GLOBE NEWSWIRE)——臨床階段領先的CRISPR基因組編輯生物製藥公司Caribou Biosciences, Inc.(納斯達克股票代碼:CRBU)今天公佈了2024年第一季度的財務業績,並回顧了最近的研發進展。
"We continue to focus on advancing four clinical-stage programs, including the parallel development of our lead allogeneic CAR-T cell therapy CB-010 in oncology and autoimmune diseases following our recent IND clearance in lupus," said Rachel Haurwitz, PhD, Caribou's president and chief executive officer. "Our clinical execution enables two clinical data readouts this year. At ASCO next month, we look forward to presenting initial dose expansion data for CB-010 in patients with second-line large B cell lymphoma. Additionally, by the end of this year we plan to present initial dose escalation data for CB-011 in relapsed or refractory multiple myeloma."
Caribou總裁兼首席執行官雷切爾·豪爾維茨博士表示:“我們繼續專注於推進四個臨床階段的項目,包括在我們最近批准狼瘡臨床試驗後,同時開發我們在腫瘤學和自身免疫性疾病領域的領先異體CAR-T細胞療法 CB-010。”“我們的臨床執行使我們今年能夠讀出兩次臨床數據。在下個月的 ASCO 上,我們期待公佈二線大 B 細胞淋巴瘤患者中 CB-010 的初始劑量擴展數據。此外,我們計劃在今年年底之前提供復發或難治性多發性骨髓瘤中 CB-011 的初始劑量遞增數據。”
Clinical highlights
CB-010, a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma
臨床亮點
CB-010,一種臨床階段的異基因抗 CD19 CAR-T 細胞療法,用於 B 細胞非霍奇金淋巴瘤
- In the ongoing ANTLER Phase 1 trial, Caribou will enroll up to 20 additional patients with second-line large B cell lymphoma (LBCL) to prospectively evaluate partial human leukocyte antigen (HLA) matching. Based on an ongoing retrospective examination of ANTLER Phase 1 trial data, partial HLA matching may lead to improved clinical outcomes.
- 在正在進行的ANTLER 1期試驗中,Caribou將再招募多達20名二線大B細胞淋巴瘤(LBCL)患者,以前瞻性地評估部分人白細胞抗原(HLA)匹配情況。根據對ANTLER 1期試驗數據的持續回顧性檢查,部分HLA匹配可能會改善臨床結果。
CB-010, a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for lupus
CB-010,一種治療狼瘡的臨床階段異基因抗 CD19 CAR-T 細胞療法
- Caribou received clearance of an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to evaluate CB-010 in the treatment of patients with lupus nephritis (LN) and extrarenal lupus (ERL).
- The GALLOP Phase 1 trial is an open-label, multicenter clinical trial designed to evaluate a single infusion of CB-010 in adult patients with LN and ERL. The trial will incorporate partial HLA matching between donor sources and patients.
- Caribou 獲得了美國食品藥品監督管理局 (FDA) 的研究性新藥 (IND) 申請的批准,該申請旨在評估 CB-010 在狼瘡腎炎 (LN) 和腎外狼瘡 (ERL) 患者治療中的作用。
- GALLOP 1 期試驗是一項開放標籤、多中心臨床試驗,旨在評估成人低血壓和急性淋巴細胞患者的單次輸注 CB-010。該試驗將納入捐贈者來源和患者之間的部分HLA匹配。
CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma
CB-011,一種臨床階段的異基因抗 BCMA CAR-T 細胞療法,用於治療多發性骨髓瘤
- Caribou is enrolling patients with relapsed or refractory multiple myeloma (r/r MM) in the dose escalation portion of the ongoing CaMMouflage Phase 1 clinical trial.
- Caribou正在將復發或難治性多發性骨髓瘤(r/r MM)患者納入正在進行的劑量遞增部分 CammouFlage 1 期臨床試驗。
CB-012, a clinical-stage allogeneic anti-CLL-1 CAR-T cell therapy for acute myeloid leukemia
CB-012,一種治療急性髓系白血病的臨床階段異基因抗 CLL-1 CAR-T 細胞療法
- Caribou is enrolling patients with relapsed or refractory acute myeloid leukemia (r/r AML) in the dose escalation portion of the ongoing AMpLify Phase 1 clinical trial.
- Caribou正在將復發或難治性急性髓系白血病(r/r AML)患者納入正在進行的劑量遞增部分 Amplify 1 期臨床試驗。
Upcoming medical meeting
2024 ASCO Annual Meeting, Chicago, IL
即將舉行的醫學會議
2024 年 ASCO 年會,伊利諾伊州芝加哥
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CB-010 ANTLER Phase 1 trial clinical data poster presentation:
A CRISPR-edited allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (CB-010) in patients with relapsed/refractory B cell non-Hodgkin lymphoma (r/r B-NHL): Updated Phase 1 results from the ANTLER trial
Boyu Hu, MD, assistant professor, director of lymphoma and CLL, division of hematology/hematologic malignancies, Huntsman Cancer Institute at the University of Utah
Monday, June 3, 2024, 9:00 am-12:00 pm CDT -
CB-012 AMpLify Phase 1 trial design poster presentation:
A first-in-human Phase 1, multicenter, open-label study of CB-012, a next-generation CRISPR-edited allogeneic anti-CLL-1 CAR-T cell therapy for adults with relapsed/refractory acute myeloid leukemia (AMpLify)
Naval Daver, MD, associate professor and director of the Leukemia Research Alliance Program, department of leukemia, The University of Texas MD Anderson Cancer Center
Monday, June 3, 2024, 9:00 am-12:00 pm CDT
- CB-010 ANTLER 1 期試驗臨床數據海報演示:
一種針對復發/難治性 B 細胞非霍奇金淋巴瘤(r/r B-NHL)患者的經過 CRISPR 編輯的同種異體抗 CD19 CAR-T 細胞療法,具有 PD-1 基因敲除 (CB-010):ANTLER 試驗更新的 1 期結果
胡博宇,醫學博士,助理教授,猶他大學亨斯邁癌症研究所血液學/血液系統惡性腫瘤部淋巴瘤和CLL主任
2024 年 6 月 3 日星期一,中部夏令時間上午 9:00 至下午 12:00 - CB-012 Amplify 第 1 階段試驗設計海報演示:
CB-012 是人體首例 1 期、多中心、開放標籤的研究,這是一種經過 CRISPR 編輯的下一代異體抗 CLL-1 CAR-T 細胞療法,適用於復發/難治性急性髓系白血病 (Amplify) 成人
Naval Daver,醫學博士,德克薩斯大學白血病系白血病研究聯盟項目副教授兼主任 MD 安德森癌症中心
2024 年 6 月 3 日星期一,中部夏令時間上午 9:00 至下午 12:00
2024 anticipated milestones
2024 年預期里程碑
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CB-010 ANTLER: At the 2024 ASCO Annual Meeting, Caribou plans to present a poster with data from the ongoing ANTLER Phase 1 trial data for CB-010. The update will include:
- Initial safety and efficacy data on the first 30 patients enrolled in dose expansion
- Updated safety and efficacy data on the 7 dose escalation patients who remained on study when the data were last reported
- The recommended Phase 2 dose (RP2D)
- Translational data (pharmacokinetics, pharmacodynamics, including B cell aplasia, and partial HLA matching)
- Timelines for clinical data on up to 20 patients with partial HLA matching
- CB-010 GALLOP: Caribou plans to initiate the GALLOP Phase 1 clinical trial in adult patients with LN and ERL by year-end 2024.
- CB-011 CaMMouflage: Caribou plans to present initial dose escalation data from the ongoing CaMMouflage Phase 1 clinical trial by year-end 2024.
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CB-012 AMpLify: Caribou plans to provide updates on dose escalation as the AMpLify Phase 1 clinical trial in r/r AML advances.
- CB-010 ANTLER:在2024年ASCO年會上,Caribou計劃展示一張海報,其中包含正在進行的 CB-010 ANTLER 1期試驗數據的數據。此次更新將包括:
- 參與劑量擴大的前30名患者的初步安全性和有效性數據
- 更新了上次報告數據時仍在研究中的7名劑量遞增患者的安全性和有效性數據
- 推薦的 2 期劑量 (RP2D)
- 轉化數據(藥代動力學、藥效學,包括 B 細胞再生障礙和部分 HLA 匹配)
- 部分HLA匹配的多達20名患者的臨床數據時間表
- CB-010 GALLOP:Caribou計劃在2024年年底之前啓動針對LN和ERL成年患者的GALLOP1期臨床試驗。
- CB-011 cammouFlage:Caribou計劃在2024年年底之前公佈正在進行的CammouFlage 1期臨床試驗的初始劑量增加數據。
- CB-012 Amplify:隨着復發/難治性急性髓細胞白血病的Amplify 1期臨床試驗的進展,Caribou計劃提供劑量增加的最新情況。
First quarter 2024 financial results
Cash, cash equivalents, and marketable securities: Caribou had $345.9 million in cash, cash equivalents, and marketable securities as of March 31, 2024, compared to $372.4 million as of December 31, 2023. The March 31, 2024 balance includes approximately $11.3 million in net proceeds from the sale of Caribou's common stock under the Company's ATM Sales Agreement. Caribou expects these cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan into Q1 2026.
2024 年第一季度財務業績
現金、現金等價物和有價證券:截至2024年3月31日,Caribou擁有3.459億美元的現金、現金等價物和有價證券,而截至2023年12月31日爲3.724億美元。2024年3月31日的餘額包括根據公司的自動櫃員機銷售協議出售Caribou普通股所得的約1,130萬美元的淨收益。Caribou預計,這些現金、現金等價物和有價證券將足以爲其2026年第一季度的當前運營計劃提供資金。
Licensing and collaboration revenue: Revenue from Caribou's licensing and collaboration agreements was $2.4 million for the three months ended March 31, 2024, compared to $3.5 million for the same period in 2023. The decrease primarily was due to the now-terminated AbbVie Collaboration and License Agreement as previously disclosed, partially offset by an increase in revenues recognized under the Information Rights Agreement Caribou entered into with Pfizer on June 29, 2023.
許可和合作收入:截至2024年3月31日的三個月,Caribou的許可和合作協議收入爲240萬美元,而2023年同期爲350萬美元。下降的主要原因是先前披露的艾伯維合作和許可協議現已終止,但部分被Caribou於2023年6月29日與輝瑞簽訂的信息權利協議確認的收入增長所抵消。
R&D expenses: Research and development expenses were $33.8 million for the three months ended March 31, 2024, compared to $25.7 million for the same period in 2023. The increase was primarily due to costs to advance pipeline programs, including the CB-010 ANTLER, CB-011 CaMMouflage, and CB-012 AMpLify Phase 1 clinical trials; personnel-related expenses, including stock-based compensation, due to headcount increases; and facilities and other allocated expenses.
研發費用:截至2024年3月31日的三個月,研發費用爲3,380萬美元,而2023年同期爲2570萬美元。增長主要是由於推進管道計劃的成本,包括 CB-010 ANTLER、CB-011 CammouFlage和 CB-012 Amplify 1期臨床試驗;人事相關費用,包括因員工人數增加而產生的股票薪酬;以及設施和其他分配支出。
G&A expenses: General and administrative expenses were $14.6 million for the three months ended March 31, 2024, compared to $8.9 million for the same period in 2023. The increase was primarily due to legal expenses and other service-related expenses, including accrued litigation settlement costs; personnel-related expenses, including stock-based compensation, due to headcount increases; and other facilities and allocated expenses. These increases were partially offset by a decrease in patent prosecution and maintenance fees.
併購費用:截至2024年3月31日的三個月,一般和管理費用爲1,460萬美元,而2023年同期爲890萬美元。增長主要是由於法律費用和其他與服務相關的費用,包括應計訴訟和解費用;人事相關費用,包括因員工人數增加而產生的股票薪酬;以及其他設施和分配費用。專利申請和維護費的減少部分抵消了這些增長。
Net loss: Caribou reported a net loss of $41.2 million for the three months ended March 31, 2024, compared to $28.0 million for the same period in 2023.
淨虧損:Caribou報告稱,截至2024年3月31日的三個月,淨虧損爲4,120萬美元,而2023年同期爲2,800萬美元。
About CB-010
CB-010 is the lead clinical-stage product candidate from Caribou's allogeneic CAR-T cell therapy platform, and it is being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 clinical trial and will be evaluated in patients with lupus nephritis (LN) and extrarenal lupus (ERL) in the GALLOP Phase 1 clinical trial. In ANTLER, Caribou is enrolling second-line patients with large B cell lymphoma (LBCL) comprised of different subtypes of aggressive r/r B-NHL (DLBCL NOS, PMBCL, HGBL, tFL, and tMZL). To Caribou's knowledge, CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to improve activity against diseases by limiting premature CAR-T cell exhaustion. CB-010 is also, to Caribou's knowledge, the first anti-CD19 allogeneic CAR-T cell therapy to be evaluated in the second-line LBCL setting and, for r/r B-NHL, CB-010 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations by the FDA. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.
關於 CB-010
CB-010 是 Caribou 異基因 CAR-T 細胞療法平台的主要臨床階段候選產品,正在進行的 ANTLER 1 期臨床試驗中正在對復發或難治性 B 細胞非霍奇金淋巴瘤(r/r B-NHL)患者進行評估,並將在GALLOP 1期臨床試驗中對狼瘡腎炎(LN)和腎外狼瘡(ERL)患者進行評估。在ANTLER,Caribou正在招收大B細胞淋巴瘤(LBCL)的二線患者,該患者由不同的侵襲性複發性B-NHL亞型(DLBCL NOS、PMBCL、HGBL、TfL和TmzL)組成。據Caribou所知,CB-010 是臨床上第一種具有PD-1基因敲除的異體CAR-T細胞療法,這是一種基因組編輯策略,旨在通過限制過早的CAR-T細胞衰竭來提高抗病活性。據Caribou所知,CB-010 也是第一種在二線LBCL環境中進行評估的抗CD19異體CAR-T細胞療法,對於復發/難治B-NHL,CB-010 已被美國食品藥品管理局授予再生醫學高級療法(RMAT)、快速通道和孤兒藥稱號。有關 ANTLER 試驗 (NCT04637763) 的更多信息,請訪問 clinicaltrials.gov。
About CB-011
CB-011 is a product candidate from Caribou's allogeneic CAR-T cell therapy platform and is being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the CaMMouflage Phase 1 trial. CB-011 is an allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA genome-editing technology. To Caribou's knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to improve antitumor activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track and orphan drug designations by the FDA. Additional information on the CaMMouflage trial (NCT05722418) can be found at clinicaltrials.gov.
關於 CB-011
CB-011 是 Caribou 同種異體 CAR-T 細胞療法平台的候選產品,在 CammouFlage 1 期試驗中,正在對復發或難治性多發性骨髓瘤(r/r MM)患者進行評估。CB-011 是一種使用 cas12a chrDNA 基因組編輯技術設計的異基因抗 BCMA CAR-T 細胞療法。據Caribou 所知,CB-011 是臨床上第一種異體 CAR-T 細胞療法,旨在通過免疫隱身策略提高抗腫瘤活性 B2M 敲除並插入 B2M—HLA-E 融合蛋白,以抑制免疫介導的排斥反應。CB-011 已獲得 FDA 的快速通道和孤兒藥認定。有關 CammouFlage 試驗 (NCT05722418) 的更多信息,請訪問 clinicaltrials.gov。
About CB-012
CB-012 is a product candidate from Caribou's allogeneic CAR-T cell therapy platform and is being evaluated in the AMpLify Phase 1 clinical trial in patients with relapsed or refractory acute myeloid leukemia (r/r AML). CB-012 is an anti-CLL-1 CAR-T cell therapy engineered with five genome edits, enabled by Caribou's patented next-generation CRISPR technology platform, which uses Cas12a chRDNA genome editing to significantly improve the specificity of genome edits. To Caribou's knowledge, CB-012 is the first allogeneic CAR-T cell therapy with both checkpoint disruption, through a PD-1 knockout, and immune cloaking, through a B2M knockout and B2M–HLA-E fusion protein insertion; both armoring strategies are designed to improve antitumor activity. Caribou has exclusively in-licensed from Memorial Sloan Kettering Cancer Center (MSKCC) in the field of allogeneic CLL-1-targeted cell therapy a panel of fully human scFvs targeting CLL-1, from which the company has selected an appropriate scFv for the generation of the company's CAR. Additional information on the AMpLify trial (NCT06128044) can be found at clinicaltrials.gov.
關於 CB-012
CB-012 是 Caribou 的異基因 CAR-T 細胞療法平台的候選產品,正在對復發或難治性急性髓系白血病(r/r AML)患者進行的 Amplify 1 期臨床試驗中進行評估。CB-012 是一種抗CLL-1 CAR-T細胞療法,經過五次基因組編輯而設計,由Caribou獲得專利的下一代CRISPR技術平台支持,該平台使用Cas12a chrDNA基因組編輯來顯著提高基因組編輯的特異性。據 Caribou 所知,CB-012 是第一種異體 CAR-T 細胞療法,它既可以通過 PD-1 敲除干擾檢查點,也可以通過 PD-1 敲除來干擾免疫隱身 B2M 敲除和 B2M—HLA-E 融合蛋白插入;兩種裝甲策略都旨在提高抗腫瘤活性。Caribou已獲得紀念斯隆·凱特琳癌症中心(MSKCC)在異體CLL-1靶向細胞療法領域的獨家許可,該小組由靶向 CLL-1 的全人源SCFV組成,該公司已從中爲該公司的CAR的生成選擇了合適的scfV。有關 Amplify 試驗 (NCT06128044) 的更多信息,請訪問 clinicaltrials.gov。
About Caribou's novel next-generation CRISPR platform
CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. There are two basic components of Class 2 CRISPR systems: the nuclease protein that cuts DNA and the RNA molecule(s) that guide the nuclease to generate a site-specific, double-stranded break, leading to an edit at the targeted genomic site. CRISPR systems are capable of editing unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function and phenotype. In response to this challenge, Caribou has developed CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced "chardonnays") that direct substantially more precise genome editing compared to all-RNA guides. Caribou is deploying the power of its chRDNA technology to carry out high efficiency multiple edits, to develop CRISPR-edited therapies.
關於 Caribou 的新型下一代 CRISPR 平台
CRISPR 基因組編輯使用易於設計的模塊化生物學工具對活細胞進行 DNA 更改。2 類 CRISPR 系統有兩個基本組成部分:切割 DNA 的核酸酶蛋白和引導核酸酶產生位點特異性雙鏈斷裂、導致目標基因組位點編輯的 RNA 分子。CRISPR系統能夠編輯意想不到的基因組位點,即脫靶編輯,這可能會對細胞功能和表型造成有害影響。爲了應對這一挑戰,Caribou開發了CRISPR混合RNA-DNA指南(chrDNA;發音爲 “chardonnays”),與全RNA指南相比,它指導的基因組編輯要精確得多。Caribou正在利用其chrDNA技術的力量進行高效的多次編輯,開發經過CRISPR編輯的療法。
About Caribou Biosciences, Inc.
Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. The company's genome-editing platform, including its Cas12a chRDNA technology, enables superior precision to develop cell therapies that are armored to potentially improve antitumor activity. Caribou is advancing a pipeline of clinical-stage off-the-shelf cell therapies from its CAR-T cell platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Follow us @CaribouBio and visit www.cariboubio.com.
關於 Caribou Biosciences, Inc.
Caribou Biosciences是一家臨床階段的CRISPR基因組編輯生物製藥公司,致力於爲患有毀滅性疾病的患者開發變革性療法。該公司的基因組編輯平台,包括其Cas12a chrDNA技術,能夠以卓越的精度開發具有潛在抗腫瘤活性的細胞療法。Caribou正在從其CAR-T細胞平台推進臨床階段的現成細胞療法產品線,這些療法是血液系統惡性腫瘤和自身免疫性疾病患者的現成治療方法。關注我們 @CaribouBio 然後訪問 www.cariboubio.com。
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential," or "continue," or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, without limitation, statements related to Caribou's strategy, plans, and objectives, and expectations regarding its clinical and preclinical development programs, including its expectations relating to the timing of status and updates from its ANTLER Phase 1 clinical trial for CB-010, including (i) the timing of reporting initial dose expansion data, translational data, follow-up dose escalation data from the ANTLER trial, disclosure of the recommended Phase 2 dose for CB-010, the possibility of improved clinical outcomes by utilizing partial human leukocyte antigen matching, and timelines for clinical data on partial HLA matching; (ii) the timing of status and updates from its CaMMouflage Phase 1 clinical trial for CB-011 and expectations regarding the timing of presenting the initial dose escalation data; (iii) the timing of status and updates from its AMpLify Phase 1 clinical trial for CB-012; (iv) the timing of status and updates from its GALLOP Phase 1 clinical trial for CB-010 in patients with LN and ERL; and (v) its expected funding runway of cash, cash equivalents, and marketable securities. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Risks and uncertainties include, without limitation, risks inherent in the development of cell therapy products; uncertainties related to the initiation, cost, timing, progress, and results of Caribou's current and future research and development programs, preclinical studies, and clinical trials; and the risk that initial, preliminary, or interim clinical trial data will not ultimately be predictive of the safety and efficacy of Caribou's product candidates or that clinical outcomes may differ as patient enrollment continues and as more patient data becomes available; the risk that preclinical study results observed will not be borne out in human patients or different conclusions or considerations are reached once additional data have been received and fully evaluated; the ability to obtain key regulatory input and approvals; as well as other risk factors described from time to time in Caribou's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent filings. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, Caribou undertakes no obligation to update publicly any forward-looking statements for any reason.
前瞻性陳述
本新聞稿包含1995年《私人證券訴訟改革法》所指的前瞻性陳述。在某些情況下,你可以通過諸如 “可能”、“將”、“應該”、“預期”、“計劃”、“預期”、“可能”、“打算”、“目標”、“項目”、“考慮”、“相信”、“估計”、“預測”、“潛在” 或 “繼續” 等術語來識別前瞻性陳述,或者這些術語或其他類似表述的否定詞,儘管不是所有前瞻性陳述包含這些單詞。這些前瞻性陳述包括但不限於與 Caribou 的戰略、計劃和目標以及對其臨床和臨床前開發計劃的預期相關的陳述,包括其對 CB-010 ANTLER 1 期臨床試驗進展時間和最新情況的預期,包括 (i) 報告初始劑量擴展數據的時機、翻譯數據、ANTLER 試驗的後續劑量遞增數據、CB-010 推薦的 2 期劑量的披露、改善的可能性臨床結果通過利用部分人類白細胞抗原匹配和部分 HLA 匹配臨床數據的時間表;(ii)其 CammoufLage 1 期 CB-011 臨床試驗的狀態和最新情況以及對提交初始劑量遞增數據時機的預期;(iii)其 CB-012 Amplify 1 期臨床試驗的狀態和更新的時機;(iv)其 GALLOP 1 期臨床試驗的狀態和更新的時機用於 LN 和 ERL 患者的 CB-010;以及 (v) 其預期的現金、現金等價物資金來源,以及有價證券。管理層認爲,這些前瞻性陳述在發表時是合理的。但是,此類前瞻性陳述受風險和不確定性的影響,實際結果可能與前瞻性陳述所表達或暗示的任何未來業績存在重大差異。風險和不確定性包括但不限於細胞療法產品開發所固有的風險;與Caribou當前和未來的研發計劃、臨床前研究和臨床試驗的啓動、成本、時間、進展和結果相關的不確定性;以及初始、初步或中期臨床試驗數據最終無法預測Caribou候選產品的安全性和有效性的風險,或者隨着患者入組的持續和患者的增加,臨床結果可能有所不同的風險數據變成可用;臨床前研究結果無法在人體患者身上得到證實或得出不同結論或考慮因素的風險;獲得關鍵監管意見和批准的能力;以及Caribou向美國證券交易委員會提交的文件中不時描述的其他風險因素,包括其截至2023年12月31日止年度的10-K表年度報告和隨後的申報。鑑於這些前瞻性陳述中存在重大不確定性,您不應依賴前瞻性陳述作爲對未來事件的預測。除非法律要求,否則Caribou沒有義務出於任何原因公開更新任何前瞻性陳述。
Caribou Biosciences, Inc. Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) | |||||||
March 31, 2024 | December 31, 2023 | ||||||
Cash, cash equivalents, and marketable securities | $ | 345,926 | $ | 372,404 | |||
Total assets | 406,825 | 432,209 | |||||
Total liabilities | 63,536 | 63,808 | |||||
Total stockholders' equity | 343,289 | 368,401 | |||||
Total liabilities and stockholders' equity | $ | 406,825 | $ | 432,209 |
Caribou Biosciences, Inc 簡明的合併資產負債表數據 (以千計) (未經審計) | |||||||
2024年3月31日 | 2023年12月31日 | ||||||
現金、現金等價物和有價證券 | $ | 345,926 | $ | 372,404 | |||
總資產 | 406,825 | 432,209 | |||||
負債總額 | 63,536 | 63,808 | |||||
股東權益總額 | 343,289 | 368,401 | |||||
負債和股東權益總額 | $ | 406,825 | $ | 432,209 |
Caribou Biosciences, Inc. Condensed Consolidated Statement of Operations (in thousands, except share and per share data) (unaudited) | |||||||
Three Months Ended, March 31, | |||||||
2024 | 2023 | ||||||
Licensing and collaboration revenue | $ | 2,429 | $ | 3,502 | |||
Operating expenses: | |||||||
Research and development | 33,788 | 25,709 | |||||
General and administrative | 14,643 | 8,909 | |||||
Total operating expenses | 48,431 | 34,618 | |||||
Loss from operations | (46,002) | (31,116) | |||||
Other income (expense): | |||||||
Change in fair value of equity securities | — | (15) | |||||
Change in fair value of the MSKCC success payments liability | 303 | 255 | |||||
Other income, net | 4,465 | 2,832 | |||||
Total other income | 4,768 | 3,072 | |||||
Net loss | (41,234) | (28,044) | |||||
Other comprehensive (loss) income: | |||||||
Net unrealized (loss) gain on available-for-sale marketable securities, net of tax | (352) | 788 | |||||
Net comprehensive loss | $ | (41,586) | $ | (27,256) | |||
Net loss per share, basic and diluted | $ | (0.46) | $ | (0.46) | |||
Weighted-average common shares outstanding, basic and diluted | 89,302,937 | 61,186,514 |
Caribou Biosciences, Inc 簡明合併運營報表 (以千計,股票和每股數據除外) (未經審計) | |||||||
截至三月三十一日的三個月 | |||||||
2024 | 2023 | ||||||
許可和協作收入 | $ | 2429 | $ | 3,502 | |||
運營費用: | |||||||
研究和開發 | 33,788 | 25,709 | |||||
一般和行政 | 14,643 | 8,909 | |||||
運營費用總額 | 48,431 | 34,618 | |||||
運營損失 | (46,002) | (31,116) | |||||
其他收入(支出): | |||||||
股權證券公允價值的變化 | — | (15) | |||||
MSKCC成功付款負債公允價值的變化 | 303 | 255 | |||||
其他收入,淨額 | 4,465 | 2,832 | |||||
其他收入總額 | 4,768 | 3,072 | |||||
淨虧損 | (41,234) | (28,044) | |||||
其他綜合(虧損)收入: | |||||||
可供出售有價證券的未實現(虧損)淨收益,扣除稅款 | (352) | 788 | |||||
淨綜合虧損 | $ | (41,586) | $ | (27,256) | |||
基本和攤薄後的每股淨虧損 | $ | (0.46) | $ | (0.46) | |||
已發行普通股、基本股和攤薄後加權平均值 | 89,302,937 | 61,186,514 |
Caribou Biosciences, Inc. contacts:
Investors:
Amy Figueroa, CFA
investor.relations@cariboubio.com
Caribou 生物科學公司聯繫方式:
投資者:
艾米·菲格羅亞,CFA
investor.relations@cariboubio.com
Media:
Peggy Vorwald, PhD
media@cariboubio.com
媒體:
Peggy Vorwald,博士
media@cariboubio.com
譯文內容由第三人軟體翻譯。