Lineage Cell Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update
Lineage Cell Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update
- Established New Services Agreement with Genentech to Support Ongoing Development of the OpRegen Program
- Long-Term Visual Benefits from a Single Administration with OpRegen Reported at 2024 Retinal Cell & Gene Therapy Innovation Summit
- OpRegen Preclinical Results Presented at 2024 Association for Research in Vision and Ophthalmology Annual Meeting
- OPC1 Clinical Study Start Up Preparation Underway
- Received CIRM Grant to Support 2nd Annual SCI Investor Symposium
- Appointed Charlotte Hubbert, Ph.D., as Vice President of Corporate Development
- 与基因泰克签订了新的服务协议,以支持OpreGen的持续开发 程式
- 2024年视网膜细胞与基因疗法创新峰会报告了单一给药的长期视觉益处
- OpreGen临床前研究结果在2024年视觉与眼科研究协会年会上公布
- OPC1 临床研究启动准备工作正在进行中
- 获得了 CIRM 补助金以支持 2和 年度SCI投资者研讨会
- 任命夏洛特·哈伯特博士为企业发展副总裁
CARLSBAD, Calif.--(BUSINESS WIRE)--May 9, 2024-- Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported its first quarter 2024 financial and operating results and will host a conference call at 4:30 p.m. Eastern Time to discuss these results and to provide a business update.
加利福尼亚州卡尔斯巴德--(美国商业资讯)--2024年5月9日-- Lineage Cell Therapeutics 纽约证券交易所美国证券交易所和TASE: LCTX)是一家为未满足的医疗需求开发异基因细胞疗法的临床阶段生物技术公司,今天公布了其2024年第一季度的财务和经营业绩,并将于美国东部时间下午 4:30 举行电话会议,讨论这些结果并提供业务最新情况。
"The quarter was highlighted by significant milestones and data updates on our lead program," stated Brian M. Culley, Lineage CEO. "A key area of attention for investors is our partnership with Roche and Genentech, and we are pleased to announce a new services agreement which reflects an additional commitment by Genentech for the benefit of the OpRegen program. We believe this agreement will enable our partners to take advantage of our cell transplant expertise to more fully investigate the promising potential of the OpRegen program and do so in a cost-effective manner. We also are planning to bring our second cell transplant program, OPC1, into the clinic this year for a condition with growing awareness of its unmet need and commercial opportunity. Lastly, we continue to build value through the advancement of our early-stage pipeline, which can help create value by capitalizing on the continued validation of our cell transplant approach."
Lineage首席执行官Brian M. Culley表示:“本季度的重大里程碑和主要计划的数据更新凸显了本季度。”“投资者关注的关键领域是我们与罗氏和基因泰克的合作伙伴关系,我们很高兴地宣布了一项新的服务协议,该协议反映了基因泰克为OpreGen计划做出的额外承诺。我们相信,该协议将使我们的合作伙伴能够利用我们的细胞移植专业知识,更全面地研究OpreGen计划的潜在潜力,并以具有成本效益的方式进行研究。我们还计划在今年将我们的第二个细胞移植项目OPC1投入临床治疗,该项目针对的患者越来越意识到其未得到满足的需求和商业机会。最后,我们将继续通过发展早期产品线来创造价值,这可以通过利用我们细胞移植方法的持续验证来帮助创造价值。”
Recent Operational Highlights
近期运营亮点
- RG6501 (OpRegen)
- Established new services agreement with Genentech, a member of the Roche Group, to support ongoing development of OpRegen. Under this new agreement, Lineage will provide additional clinical, technical, training and manufacturing services that further support the ongoing advancement and optimization of the OpRegen program. These additional services will be fully funded by Genentech and include: (i) activities to support the ongoing Phase 1/2a study and currently-enrolling Phase 2a study; and (ii) additional technical training and materials related to Lineage's cell therapy technology platform to support commercial manufacturing strategies.
- Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including support for the ongoing Phase 2a clinical study in patients with GA secondary to AMD.
- Positive clinical data from long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen presented by David Telander, MD, PhD, Retinal Consultants Medical Group, at the 2024 Retinal Cell & Gene Therapy Innovation Summit.
- Mean BCVA gain of 5.5 letters at 24 months in Cohort 4 patients (less advanced geographic atrophy)
- Mean BCVA gains greater among patients with improvement in outer retinal structure (+7.4 letters)
- Maintenance or increases in external limiting membrane (ELM) and retinal pigment epithelium (RPE) layers at 24 months observed in patients with extensive coverage of OpRegen across the areas of GA
- Data suggests OpRegen may counteract RPE cell dysfunction and cell loss secondary to geographic atrophy by providing support to remaining retinal cells, with multi-year effects observed following a single administration
- Preclinical results from a surgical development study of OpRegen presented by Rachel N. Andrews, DVM, PhD, DACVP, Genentech, a member of the Roche Group, at 2024 Association for Research in Vision and Ophthalmology Annual Meeting (2024 ARVO).
- OPC1
- DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study for the treatment of subacute and chronic spinal cord patient start-up activities underway.
- Received an Education Conference II Grant from the California Institute for Regenerative Medicine (CIRM), to support the 2nd Annual Spinal Cord Injury Investor Symposium, hosted in partnership with the Christopher & Dana Reeve Foundation, to be held on June 26 and 27, 2024 at the Sanford Consortium for Regenerative Medicine in La Jolla, CA.
- Corporate Updates
- Appointed veteran industry executive Dr. Charlotte Hubbert as Vice President of Corporate Development. Dr. Hubbert previously served as Partner and Head of Gates Foundation Venture Capital, an initiative at the Bill and Melinda Gates Foundation Strategic Investment Fund, and most recently served in the leadership team at NanoString Technologies. She currently serves on the Board of Directors of the Beckman Research Institute at the City of Hope and is a Strategic Director at Madrona Venture Group.
- RG6501 (OpreGen)
- 与罗氏集团成员基因泰克签订了新的服务协议,以支持OpreGen的持续发展。根据这项新协议,Lineage将提供额外的临床、技术、培训和制造服务,以进一步支持OpreGen计划的持续推进和优化。这些额外服务将由基因泰克全额资助,包括:(i)支持正在进行的1/2a期研究和目前注册的2a期研究的活动;(ii)与Lineage细胞疗法技术平台相关的其他技术培训和材料,以支持商业制造战略。
- 在我们的领导下继续执行死刑 合作 与罗氏和基因泰克在多个职能领域合作,包括支持 正在进行的 针对继发于AMD的GA患者的2a期临床研究。
- 来自OpreGen1/2a期临床研究患者的长期随访的阳性临床数据 呈现 作者:视网膜顾问医疗集团医学博士、博士大卫·泰兰德在 2024 视网膜细胞与基因疗法创新峰会。
- 队列4患者在24个月内平均BCVA增幅为5.5个字母(不太严重的地理萎缩)
- 视网膜外层结构改善患者的平均BCVA增幅更大(+7.4 个字母)
- 在 GA 区域广泛覆盖 OpreGen 的患者中,观察到 24 个月时外部限制膜 (ELM) 和视网膜色素上皮 (RPE) 层维持或增加
- 数据表明,OpreGen可以通过为剩余的视网膜细胞提供支持来抵消RPE细胞功能障碍和继发于地理萎缩的细胞流失,单次给药后可观察到多年的效果
- 罗氏集团成员基因泰克副总裁、DVM、博士、DACVP Rachel N. Andrews发表的OpreGen外科发育研究的临床前结果 2024 年视觉与眼科学研究协会年会 (2024 ARVO)。
- OPC1
- 治疗亚急性和慢性脊髓患者的DOSED(输送治疗脊髓损伤的少突胶质细胞祖细胞:评估一种新设备)临床研究正在进行中。
- 已收到 一个 第二届教育会议补助金 来自 加州再生医学研究所 (CIRM),以支持 2和 年度脊髓损伤投资者研讨会,与克里斯托弗和达娜·里夫基金会合作主办,将于2024年6月26日和27日在加利福尼亚州拉霍亚的桑福德再生医学联盟举行。
- 企业最新消息
- 被任命 资深行业高管夏洛特·哈伯特博士担任企业发展副总裁。哈伯特博士曾担任盖茨基金会风险投资的合伙人兼负责人,盖茨基金会风险投资是比尔和梅琳达·盖茨基金会战略投资基金的一项计划,最近在NanoString Technologies的领导团队任职。她目前在希望之城贝克曼研究所董事会任职,并且是麦德罗纳风险投资集团的战略董事。
Balance Sheet Highlights
资产负债表亮点
Cash, cash equivalents, and marketable securities of $43.6 million as of March 31, 2024, is expected to support planned operations into Q3 2025.
截至2024年3月31日,现金、现金等价物和有价证券为4,360万美元,预计将为2025年第三季度的计划运营提供支持。
First Quarter Operating Results
第一季度经营业绩
Revenues: Lineage's revenue is generated primarily from collaboration revenues and royalties. Total revenues for the three months ended March 31, 2024 were approximately $1.4 million, a net decrease of $1.0 million as compared to $2.4 million for the same period in 2023. The decrease was primarily driven by lower collaboration and licensing revenue recognized from deferred revenues under the collaboration and license agreement with Roche.
收入:Lineage的收入主要来自合作收入和特许权使用费。截至2024年3月31日的三个月,总收入约为140万美元,与2023年同期的240万美元相比净减少了100万美元。下降的主要原因是根据与罗氏的合作和许可协议,从递延收入中确认的合作和许可收入减少。
Operating Expenses: Operating expenses are primarily comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended March 31, 2024 were $8.1 million, a decrease of $0.9 million as compared to $9.0 million for the same period in 2023.
运营费用:运营费用主要包括研发(“研发”)费用以及一般和管理(“G&A”)费用。截至2024年3月31日的三个月,总运营支出为810万美元,与2023年同期的900万美元相比减少了90万美元。
R&D Expenses: R&D expenses for the three months ended March 31, 2024 were $3.0 million, a net decrease of $1.2 million as compared to $4.2 million for the same period in 2023. The net decrease was primarily driven by $0.4 million for our OPC1 program, $0.3 million for our preclinical programs, and $0.2 million for our OpRegen program. Another $0.3 million of the decrease was attributable to other research and development expenses, primarily related to reduced manufacturing activities.
研发费用:截至2024年3月31日的三个月,研发费用为300万美元,与2023年同期的420万美元相比净减少了120万美元。净减少主要是由我们的OPC1项目40万美元、临床前项目的30万美元以及OpreGen计划的20万美元推动的。另外30万美元的减少归因于其他研发费用,主要与制造活动的减少有关。
G&A Expenses: G&A expenses for the three months ended March 31, 2024 were $5.0 million, a net increase of $0.3 million as compared to approximately $4.7 million for the same period in 2023. The increase was primarily driven by $0.2 million in stock-based compensation expenses, and an overall increase in costs incurred for consulting services.
并购费用:截至2024年3月31日的三个月,并购支出为500万美元,与2023年同期的约470万美元相比,净增加30万美元。增长主要是由20万美元的股票薪酬支出以及咨询服务成本的总体增加所推动的。
Loss from Operations: Loss from operations for the three months ended March 31, 2024 were $6.7 million, an increase of $0.1 million as compared to $6.6 million for the same period in 2023.
运营亏损:截至2024年3月31日的三个月,运营亏损为670万美元,与2023年同期的660万美元相比增加了10万美元。
Other Income/(Expenses), Net: Other income (expenses), net for the three months ended March 31, 2024 was comprised of other income of $0.1 million, compared to other income of $0.4 million for the same period in 2023. The net decrease was primarily driven by the employee retention credit recognized in the prior year, partially offset by exchange rate fluctuations related to Lineage's international subsidiaries.
截至2024年3月31日的三个月,其他收入/(支出),净额:其他收入(支出)包括10万美元的其他收入,而2023年同期的其他收入为40万美元。净减少的主要原因是去年确认的员工留存额度,部分被与Lineage国际子公司相关的汇率波动所抵消。
Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2024 was $6.5 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $4.4 million, or $0.03 per share (basic and diluted), for the same period in 2023.
归属于Lineage的净亏损:截至2024年3月31日的三个月,归属于Lineage的净亏损为650万美元,合每股亏损0.04美元(基本和摊薄后),而2023年同期归属于Lineage的净亏损为440万美元,合每股亏损0.03美元(基本和摊薄后)。
Conference Call and Webcast
电话会议和网络直播
Interested parties may access the conference call on May 9th, 2024, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage's website. A replay of the webcast will be available on Lineage's website for 30 days and a telephone replay will be available through May 15th, 2024, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 1330332.
有兴趣的人士可以在5月9日参加电话会议第四,2024年,从美国和加拿大拨打 (800) 715-9871,并应申请 “Lineage Cell Therapeutics Call”。电话会议的网络直播将在以下网址在线播出 投资者 Lineage网站的部分。网络直播的重播将在Lineage的网站上播放,为期30天,电话重播将持续到5月15日第四,2024 年,从美国和加拿大拨打 (800) 770-2030,然后输入会议证号 1330332。
About Lineage Cell Therapeutics, Inc.
关于Lineage Cell Therapeutics, Inc
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage's programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient's functional activity. Lineage's neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Lineage Cell Therapeutics是一家处于临床阶段的生物技术公司,正在开发新型或 “现成的” 细胞疗法,以满足未满足的医疗需求。Lineage的计划基于其专有的基于细胞的技术平台以及相关的开发和制造能力。通过该平台,Lineage设计、开发、制造和测试具有与人体天然细胞相似或相同的解剖和生理功能的特殊人体细胞。这些细胞是通过将定向分化方案应用于已建立、特征明确和自我更新的多能细胞系而产生的。这些协议生成的细胞具有与特定和所需的发育谱系相关的特征。将源自此类谱系的细胞移植到患者体内,以替代或支持因退行性疾病、衰老或创伤而缺失或功能失调的细胞,并恢复或增强患者的功能活动。Lineage专注于神经科学的产品线目前包括:(i)Opregen,一种视网膜色素上皮细胞疗法,这是一种视网膜色素上皮细胞疗法,目前正在与罗氏和罗氏集团旗下的基因泰克进行全球合作开发,用于治疗年龄相关性黄斑变性的地理萎缩;(ii)OPC1,一种处于1/2a期开发的用于治疗脊髓损伤的少突胶质细胞祖细胞疗法; (iii) ANP1,一种可能治疗听觉神经病变的听觉神经元祖细胞疗法;(iv) PNC1,a感光神经细胞疗法,可能用于治疗因感光器功能障碍或损伤引起的视力丧失;以及 (v) RND1,一种与Eterna Therapeutics Inc.合作开发的新型低免疫诱导多能干细胞系。欲了解更多信息,请访问 www.lineagecell.com 或者在 X/Twitter 上关注该公司 @LineageCell。
Forward-Looking Statements
前瞻性陈述
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Lineage's forward-looking statements are based upon its current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Such statements include, but are not limited to, statements relating to: the benefits of our new services agreement Genentech and its impact on advancing the OpRegen program; the commencement of the DOSED clinical study for OPC1; that our cash, cash equivalents and marketable securities is sufficient to support our planned operations into the third quarter of 2025; and the potential of our early-stage pipeline to create value. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to use our cash, cash equivalents and marketable securities more quickly than expected; that clinical trials of our product candidates may not commence, progress or be completed as expected due to many factors within and outside of our control; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that OpRegen may never be proven to provide durable anatomical functional improvements in dry-AMD patients, that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that the ongoing Israel-Hamas war may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage's business and other risks discussed in Lineage's filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's most recent Annual Report on Form 10-K filed with the SEC and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.
Lineage提醒您,本新闻稿中包含的所有陈述,除历史事实陈述外,均为前瞻性陈述。在某些情况下,前瞻性陈述可以通过诸如 “相信”、“目标”、“可能”、“将”、“估计”、“继续”、“预测”、“设计”、“打算”、“期望”、“可能”、“计划”、“潜在”、“预测”、“寻求”、“应该”、“考虑”、“项目” 等术语来识别 “目标”、“倾向” 或这些词语和类似表述的否定版本。Lineage的前瞻性陈述基于其当前的预期和信念,涉及可能永远无法实现或可能被证明不正确的假设。此类声明包括但不限于与以下内容有关的声明:我们的新服务协议基因泰克的好处及其对推进OpreGen计划的影响;OPC1的DOSED临床研究的开始;我们的现金、现金等价物和有价证券足以支持我们2025年第三季度的计划运营;以及我们早期创造价值的潜力。前瞻性陈述涉及已知和未知的风险、不确定性和其他因素,这些因素可能导致Lineage的实际业绩、业绩或成就与本新闻稿中前瞻性陈述所表达或暗示的未来业绩、业绩或成就存在重大差异,包括但不限于以下风险:我们可能需要将现金分配给意外事件和费用,导致我们使用现金、现金等价物和有价证券的速度超出预期;该临床试验我们的由于我们无法控制的许多因素,候选产品可能无法按预期开始、进展或完成;候选产品的早期临床和/或非临床研究的积极发现可能无法预测该候选产品的后续临床和/或非临床研究的成功;OpreGen可能永远无法被证明可以为干性AMD患者提供持久的解剖学功能改善,竞争性替代疗法可能会对OpenRegen的商业潜力产生不利影响;罗氏和基因瑞康 Tech 可能无法成功推进OpreGen或成功完成OpreGen的进一步临床试验和/或在任何特定司法管辖区获得监管部门对OpreGen的批准;持续的以色列-哈马斯战争可能会对我们的制造过程产生重大和不利影响,包括细胞库和候选细胞疗法产品的制造,所有这些都由我们在以色列耶路撒冷的子公司进行;Lineage可能无法按照目前的良好生产制造条件生产足够的临床数量的候选产品实践;以及Lineage向美国证券交易委员会(SEC)提交的文件中讨论的Lineage业务中固有的风险和不确定性以及其他风险。有关这些风险和其他风险的更多信息包含在Lineage向美国证券交易委员会提交的定期报告中的 “风险因素” 标题下,包括Lineage向美国证券交易委员会提交的最新10-K表年度报告及其其他报告,这些报告可在美国证券交易委员会的网站上查阅。提醒您不要过分依赖前瞻性陈述,这些陈述仅代表其发表之日。除非法律要求,否则Lineage没有义务更新此类声明以反映其发布之日后发生的事件或存在的情况。这些警示性陈述明确限制了所有前瞻性陈述的全部内容。
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) | ||||||||
March 31, 2024 | December 31, 2023 | |||||||
(Unaudited) | ||||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 43,576 | $ | 35,442 | ||||
Marketable securities | 45 | 50 | ||||||
Accounts receivable, net | 77 | 745 | ||||||
Prepaid expenses and other current assets | 2,018 | 2,204 | ||||||
Total current assets | 45,716 | 38,441 | ||||||
NONCURRENT ASSETS | ||||||||
Property and equipment, net | 2,104 | 2,245 | ||||||
Operating lease right-of-use assets | 2,855 | 2,522 | ||||||
Deposits and other long-term assets | 596 | 577 | ||||||
Goodwill | 10,672 | 10,672 | ||||||
Intangible assets, net | 46,540 | 46,562 | ||||||
TOTAL ASSETS | $ | 108,483 | $ | 101,019 | ||||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Accounts payable and accrued liabilities | $ | 5,683 | $ | 6,270 | ||||
Operating lease liabilities, current portion | 1,052 | 830 | ||||||
Finance lease liabilities, current portion | 49 | 52 | ||||||
Deferred revenues, current portion | 10,106 | 10,808 | ||||||
Total current liabilities | 16,890 | 17,960 | ||||||
LONG-TERM LIABILITIES | ||||||||
Deferred tax liability | 273 | 273 | ||||||
Deferred revenues, net of current portion | 18,177 | 18,693 | ||||||
Operating lease liabilities, net of current portion | 2,074 | 1,979 | ||||||
Finance lease liabilities, net of current portion | 79 | 91 | ||||||
TOTAL LIABILITIES | 37,493 | 38,996 | ||||||
Commitments and contingencies (Note 13) | ||||||||
SHAREHOLDERS' EQUITY | ||||||||
Preferred shares, no par value, 2,000 shares authorized; none issued and outstanding as of March 31, 2024 and December 31, 2023 | — | — | ||||||
Common shares, no par value, 450,000 shares authorized as of March 31, 2024 and December 31, 2023; 188,754 and 174,987 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 466,571 | 451,343 | ||||||
Accumulated other comprehensive loss | (2,771) | (3,068) | ||||||
Accumulated deficit | (391,398) | (384,856) | ||||||
Lineage's shareholders' equity | 72,402 | 63,419 | ||||||
Noncontrolling deficit | (1,412) | (1,396) | ||||||
Total shareholders' equity | 70,990 | 62,023 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 108,483 | $ | 101,019 |
LINEAGE CELL疗法有限公司和子公司 简明的合并资产负债表 (以千计) | ||||||||
2024年3月31日 | 2023年12月31日 | |||||||
(未经审计) | ||||||||
资产 | ||||||||
流动资产 | ||||||||
现金和现金等价物 | $ | 43,576 | $ | 35,442 | ||||
有价证券 | 45 | 50 | ||||||
应收账款,净额 | 77 | 745 | ||||||
预付费用和其他流动资产 | 2,018 | 2,204 | ||||||
流动资产总额 | 45,716 | 38,441 | ||||||
非流动资产 | ||||||||
财产和设备,净额 | 2,104 | 2,245 | ||||||
经营租赁使用权资产 | 2,855 | 2,522 | ||||||
存款和其他长期资产 | 596 | 577 | ||||||
善意 | 10,672 | 10,672 | ||||||
无形资产,净额 | 46,540 | 46,562 | ||||||
总资产 | $ | 108,483 | $ | 101,019 | ||||
负债和股东权益 | ||||||||
流动负债 | ||||||||
应付账款和应计负债 | $ | 5,683 | $ | 6,270 | ||||
经营租赁负债,流动部分 | 1,052 | 830 | ||||||
融资租赁负债,流动部分 | 49 | 52 | ||||||
递延收入,当期部分 | 10,106 | 10,808 | ||||||
流动负债总额 | 16,890 | 17,960 | ||||||
长期负债 | ||||||||
递延所得税负债 | 273 | 273 | ||||||
递延收入,扣除当期部分 | 18,177 | 18,693 | ||||||
经营租赁负债,扣除流动部分 | 2,074 | 1,979 | ||||||
融资租赁负债,扣除流动部分 | 79 | 91 | ||||||
负债总额 | 37,493 | 38,996 | ||||||
承诺和意外开支(附注13) | ||||||||
股东权益 | ||||||||
优先股,无面值,授权2,000股;截至2024年3月31日和2023年12月31日,未发行和流通股票 | — | — | ||||||
普通股,无面值,截至2024年3月31日和2023年12月31日已获授权45万股;截至2024年3月31日和2023年12月31日分别已发行和流通188,754股和174,987股股票 | 466,571 | 451,343 | ||||||
累计其他综合亏损 | (2,771) | (3,068) | ||||||
累计赤字 | (391,398) | (384,856) | ||||||
Lineage的股东权益 | 72,402 | 63,419 | ||||||
非控制性赤字 | (1,412) | (1,396) | ||||||
股东权益总额 | 70,990 | 62,023 | ||||||
负债总额和股东权益 | $ | 108,483 | $ | 101,019 |
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) (UNAUDITED) | ||||||||
Three Months Ended March 31, | ||||||||
2024 | 2023 | |||||||
REVENUES: | ||||||||
Collaboration revenues | $ | 1,187 | $ | 2,121 | ||||
Royalties, license and other revenues | 257 | 265 | ||||||
Total revenues | 1,444 | 2,386 | ||||||
OPERATING EXPENSES: | ||||||||
Cost of sales | 98 | 119 | ||||||
Research and development | 3,010 | 4,185 | ||||||
General and administrative | 4,997 | 4,724 | ||||||
Total operating expenses | 8,105 | 9,028 | ||||||
Loss from operations | (6,661) | (6,642) | ||||||
OTHER INCOME (EXPENSES): | ||||||||
Interest income, net | 462 | 410 | ||||||
(Loss) gain on marketable equity securities, net | (5) | 40 | ||||||
Foreign currency transaction gain/(loss), net | (354) | (472) | ||||||
Other income | — | 457 | ||||||
Total other income (expenses), net | 103 | 435 | ||||||
LOSS BEFORE INCOME TAXES | (6,558) | (6,207) | ||||||
Provision for income tax benefit | — | 1,803 | ||||||
NET LOSS | (6,558) | (4,404) | ||||||
Net loss attributable to noncontrolling interest | 16 | 32 | ||||||
NET LOSS ATTRIBUTABLE TO LINEAGE | $ | (6,542) | $ | (4,372) | ||||
Net loss per common share attributable to Lineage | $ | (0.04) | $ | (0.03) | ||||
Weighted-average common shares used to compute basic and | 182,909 | 170,127 |
LINEAGE CELL疗法有限公司和子公司 简明合并运营报表 (以千计,每股数据除外) (未经审计) | ||||||||
截至3月31日的三个月 | ||||||||
2024 | 2023 | |||||||
收入: | ||||||||
协作收入 | $ | 1,187 | $ | 2,121 | ||||
特许权使用费、许可和其他收入 | 257 | 265 | ||||||
总收入 | 1,444 | 2,386 | ||||||
运营费用: | ||||||||
销售成本 | 98 | 119 | ||||||
研究和开发 | 3,010 | 4,185 | ||||||
一般和行政 | 4,997 | 4,724 | ||||||
运营费用总额 | 8,105 | 9,028 | ||||||
运营损失 | (6,661) | (6,642) | ||||||
其他收入(支出): | ||||||||
利息收入,净额 | 462 | 410 | ||||||
有价股权证券(亏损)收益,净额 | (5) | 40 | ||||||
外币交易收益/(亏损),净额 | (354) | (472) | ||||||
其他收入 | — | 457 | ||||||
其他收入(支出)总额,净额 | 103 | 435 | ||||||
所得税前亏损 | (6,558) | (6,207) | ||||||
所得税优惠准备金 | — | 1,803 | ||||||
净亏损 | (6,558) | (4,404) | ||||||
归因于非控股权益的净亏损 | 16 | 32 | ||||||
归因于血统的净亏损 | $ | (6,542) | $ | (4,372) | ||||
归属于Lineage的每股普通股净亏损 | $ | (0.04) | $ | (0.03) | ||||
用于计算基本和普通股的加权平均值 | 182,909 | 170,127 |
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS) (UNAUDITED) | ||||||||
Three Months Ended March 31, | ||||||||
2024 | 2023 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net loss attributable to Lineage | $ | (6,542) | $ | (4,372) | ||||
Net loss attributable to noncontrolling interest | (16) | (32) | ||||||
Adjustments to reconcile net loss attributable to Lineage Cell Therapeutics, Inc. | ||||||||
Loss (gain) on marketable equity securities, net | 5 | (40) | ||||||
Accretion of income on marketable debt securities | — | (326) | ||||||
Depreciation and amortization expense | 153 | 138 | ||||||
Change in right-of-use assets and liabilities | (10) | — | ||||||
Amortization of intangible assets | 22 | 33 | ||||||
Stock-based compensation | 1,163 | 1,031 | ||||||
Deferred income tax benefit | — | (1,803) | ||||||
Foreign currency remeasurement and other loss | 371 | 465 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable | 668 | 95 | ||||||
Prepaid expenses and other current assets | 195 | (847) | ||||||
Accounts payable and accrued liabilities | (574) | (3,463) | ||||||
Deferred revenue | (1,218) | (2,121) | ||||||
Net cash used in operating activities | (5,783) | (11,242) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Purchases of marketable debt securities | — | (7,718) | ||||||
Maturities of marketable debt securities | — | 23,332 | ||||||
Purchase of equipment | (38) | (188) | ||||||
Net cash (used in) provided by investing activities | (38) | 15,426 | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Proceeds from employee options exercised | 132 | 51 | ||||||
Common shares received and retired for employee taxes paid | (23) | (37) | ||||||
Proceeds from sale of common shares | 14,037 | — | ||||||
Payments for offering costs | (112) | — | ||||||
Repayment of finance lease liabilities | (13) | (13) | ||||||
Net cash provided by financing activities | 14,021 | 1 | ||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (70) | (100) | ||||||
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 8,130 | 4,085 | ||||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: | ||||||||
At beginning of the period | 35,992 | 11,936 | ||||||
At end of the period | $ | 44,122 | $ | 16,021 |
LINEAGE CELL疗法有限公司和子公司 简明的合并现金流量表 (以千计) (未经审计) | ||||||||
截至3月31日的三个月 | ||||||||
2024 | 2023 | |||||||
来自经营活动的现金流: | ||||||||
归因于Lineage的净亏损 | $ | (6,542) | $ | (4,372) | ||||
归因于非控股权益的净亏损 | (16) | (32) | ||||||
调整以核对归属于Lineage Cell Therapeutics, Inc.的净亏损 | ||||||||
有价股票证券亏损(收益),净额 | 5 | (40) | ||||||
有价债务证券收入的增加 | — | (326) | ||||||
折旧和摊销费用 | 153 | 138 | ||||||
使用权资产和负债的变化 | (10) | — | ||||||
无形资产的摊销 | 22 | 33 | ||||||
基于股票的薪酬 | 1,163 | 1,031 | ||||||
递延所得税优惠 | — | (1,803) | ||||||
外币调整和其他损失 | 371 | 465 | ||||||
运营资产和负债的变化: | ||||||||
应收账款 | 668 | 95 | ||||||
预付费用和其他流动资产 | 195 | (847) | ||||||
应付账款和应计负债 | (574) | (3,463) | ||||||
递延收入 | (1,218) | (2,121) | ||||||
用于经营活动的净现金 | (5,783) | (11,242) | ||||||
来自投资活动的现金流: | ||||||||
购买有价债务证券 | — | (7,718) | ||||||
有价债务证券的到期日 | — | 23,332 | ||||||
购买设备 | (38) | (188) | ||||||
投资活动提供的净现金(用于) | (38) | 15,426 | ||||||
来自融资活动的现金流量: | ||||||||
行使员工期权的收益 | 132 | 51 | ||||||
因缴纳的员工税而收到和退回的普通股 | (23) | (37) | ||||||
出售普通股的收益 | 14,037 | — | ||||||
为提供费用而付款 | (112) | — | ||||||
偿还融资租赁负债 | (13) | (13) | ||||||
融资活动提供的净现金 | 14,021 | 1 | ||||||
汇率变动对现金、现金等价物和限制性现金的影响 | (70) | (100) | ||||||
现金、现金等价物和限制性现金的净增长 | 8,130 | 4,085 | ||||||
现金、现金等价物和限制性现金: | ||||||||
在时期开始时 | 35,992 | 11,936 | ||||||
在期间结束时 | $ | 44,122 | $ | 16,021 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240509142533/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963
Lineage Cell Thapeutics, Inc.
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576
生命科学顾问
丹尼尔·费里
(daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
Russo Partners — 媒体关系
尼克·约翰逊或大卫·舒尔
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
Source: Lineage Cell Therapeutics, Inc.
来源:Lineage Cell Therapeutics, Inc