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Presented positive 6-month clinical results of ongoing type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression overcome immune recognition, while continuing to function and persist with stable C-peptide
展示了正在进行的1型糖尿病研究的积极6个月临床结果,结果显示经过低免疫修饰的胰岛细胞在没有免疫抑制的情况下移植后,能够克服免疫识别,并持续发挥功能,保持稳定的C肽水平。
New England Journal of Medicine published positive 12-week clinical results of the type 1 diabetes study
新英格兰医学杂志发表了1型糖尿病研究的积极12周临床结果。
Recent FDA INTERACT meeting increases confidence in moving forward with GMP master cell bank for SC451 and in filing SC451 Investigational New Drug Application (IND) as early as 2026
最近的FDA INTERACT会议增强了对推进SC451的GMP主细胞库以及最早在2026年提交SC451新药临床试验申请(IND)的信心。
Expect to file IND for SG299 in a B-cell related disease as early as 2026
预计最早在2026年为SG299提交与B细胞相关疾病的IND申请。
Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases and VIVID trial for SC262 in relapsed/refractory B-cell malignancies; expect to report clinical data from both studies in 2025
在B细胞介导的自身免疫疾病中为SC291进行GLEAM试验,以及在复发/难治性B细胞恶性肿瘤中为SC262进行VIVID试验的患者招募工作正在进行中;预计将在2025年报告两项研究的临床数据。
Raised aggregate gross proceeds of approximately $105 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and equity financing in July and August 2025; expected cash runway into the second half of 2026
通过Sana的市值发行机制(ATM)及2025年7月和8月的股权融资,出售普通股筹集了约1.05亿美元的总收益;预计现金跑道可延续至2026年下半年。
Q2 2025 cash position of $72.7 million and pro forma Q2 2025 cash position of $177.2 million including gross proceeds from sales of common stock through the ATM and equity financing in July and August 2025
2025年第二季度现金余额为7,270万美元,包含2025年7月和8月通过ATM销售普通股及股权融资的毛收入后的2025年第二季度模拟现金余额为1.772亿美元。
SEATTLE, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the second quarter 2025.
西雅图,2025年8月11日(环球新闻社)——Sana生物技术公司(纳斯达克股票代码:SANA),一家专注于创造和提供工程细胞作为药物的公司,今天公布了2025年第二季度的财务结果和业务亮点。
“We are pleased with the progress with the type 1 diabetes program, including recent FDA feedback on our HIP-edited GMP master cell bank and non-clinical testing plan for SC451, positive UP421 6-month clinical results presented at an invited talk at the American Diabetes Association Annual Meeting and World Transplant Congress 2025, and UP421 3-month clinical results published in the .
“我们对1型糖尿病项目的进展感到满意,包括FDA对我们HIP编辑的GMP主细胞库和SC451的非临床测试计划的近期反馈,在美国糖尿病协会年会和2025年世界移植大会上的特邀演讲中展示的UP421六个月积极临床结果,以及UP421三个月临床结果的发表。
New England Journal of Medicine
新英格兰医学杂志
,” said Steve Harr, Sana’s President and Chief Executive Officer. “Type 1 diabetes affects over 9 million people worldwide, and we are positioned to deliver on our goal of a broadly accessible single treatment with no immunosuppression leading to long-term normal blood glucose without exogenous insulin in patients with type 1 diabetes.
”,Sana公司总裁兼首席执行官史蒂夫·哈尓表示。“1型糖尿病影响着全球超过900万人,我们的目标是提供一种广泛可用的单一疗法,无需免疫抑制即可让1型糖尿病患者长期维持正常血糖水平,且无需外源性胰岛素。”
We expect to file the IND for SC451 as early as next year, and we also look forward to continuing progress in the rest of our pipeline. We have raised over $100 million in new capital since the end of the second quarter, strengthening our balance sheet and allowing us to continue to invest appropriately in moving our pipeline forward.”.
我们预计最早明年提交SC451的IND申请,我们也期待继续推进我们的其他管线进展。自第二季度末以来,我们已经筹集了超过1亿美元的新资金,这增强了我们的资产负债表,并使我们能够继续适当投资以推动我们的研发管线向前发展。
Recent Corporate Highlights
近期公司亮点
Announced positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression.
宣布了一项由研究者发起的、首次人体移植异基因原代胰岛细胞疗法UP421(采用低免疫平台技术)治疗1型糖尿病患者的积极结果,且未使用任何免疫抑制剂。
UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into type 1 diabetes patients without the use of any immunosuppression.
UP421是一种用于治疗1型糖尿病患者的主要人类HIP修饰胰岛细胞疗法。这项由研究者发起的试验旨在了解移植到1型糖尿病患者体内的HIP修饰胰岛细胞的安全性、免疫逃逸、胰岛细胞存活和β细胞功能(通过C肽产生来衡量),且不使用任何免疫抑制。
The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator. .
该试验正在乌普萨拉大学医院进行,临床试验授权由佩尔-奥拉·卡尔松博士担任主要研究者。
Results of the study through 6 months after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with a mixed meal tolerance test during testing at these timepoints, consistent with insulin secretion in response to a meal.
通过细胞移植后6个月的研究结果表明,通过循环C肽(一种表明移植的β细胞正在产生胰岛素的生物标志物)的存在,可以证明胰腺β细胞的存活和功能。在这些时间点进行测试时,混合餐耐受试验中的C肽水平也有所增加,这与餐后胰岛素分泌的反应一致。
12-week PET-MRI scanning also demonstrated islet cells at the transplant site. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection..
12周的PET-MRI扫描也显示移植部位有胰岛细胞。研究未发现任何安全问题,且经过HIP修饰的胰岛细胞成功逃避了免疫检测。
Announced that the
宣布了
New England Journal of Medicine
新英格兰医学杂志
published a journal article titled “Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression” (DOI: 10.1056/NEJMoa2503822). The article discusses 12-week results from this study.
发表了一篇题为《无免疫抑制的同种异体β细胞移植存活》的期刊文章(DOI:10.1056/NEJMoa2503822)。文章讨论了这项研究的12周结果。
Sana and Uppsala University Hospital presented 6-month data at the 85
Sana和乌普萨拉大学医院在第85届会议上展示了6个月的数据
th
泰国
Annual American Diabetes Association (ADA) Scientific Sessions and the World Transplant Congress 2025, and expect to report additional data from the IST, including longer-term follow-up, as the year progresses.
美国糖尿病协会(ADA)年度科学会议和2025年世界移植大会,并预计在年内报告来自IST的更多数据,包括较长期的随访数据。
Advancing our pipeline across multiple indications and modalities:
推进我们在多种适应症和模式下的研发管线:
Type 1 Diabetes – The clinical study of gene-modified primary islet cells (UP421) continues to evaluate safety, survival, and function of these cells. Sana continues pre-clinical development of SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy, and a recent FDA INTERACT meeting increases our confidence in moving forward with our HIP-edited master cell bank for GMP manufacturing and our non-clinical testing plan.
1型糖尿病——基因修饰的原代胰岛细胞(UP421)的临床研究继续评估这些细胞的安全性、存活率和功能。Sana继续推进SC451的临床前开发,这是一种O型阴性、HIP修饰的iPSC衍生胰岛细胞疗法,最近与FDA的INTERACT会议增强了我们对推进HIP编辑主细胞库进行GMP生产和非临床测试计划的信心。
.
。
Sana expects to file an IND for SC451 as early as 2026.
Sana预计最早将在2026年为SC451提交IND申请。
Allogeneic CAR T cells – Sana is enrolling patients in both the GLEAM and VIVID trials and expects to share data in 2025.
同种异体CAR T细胞——Sana正在GLEAM和VIVID试验中招募患者,并预计在2025年分享数据。
The GLEAM trial is a Phase 1 study evaluating SC291, a HIP-modified CD19-directed allogeneic CAR T cell therapy, in patients with B-cell mediated autoimmune diseases, including refractory systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The VIVID trial is a Phase 1 study evaluating SC262, a HIP-modified CD22-directed allogeneic CAR T cell therapy, in patients with relapsed and/or refractory B-cell malignancies who have received prior CD19-directed CAR T therapy..
GLEAM试验是一项1期研究,评估SC291(一种HIP修饰的CD19导向同种异体CAR-T细胞疗法)在B细胞介导的自身免疫疾病患者中的应用,包括难治性系统性红斑狼疮和抗中性粒细胞胞浆抗体(ANCA)相关血管炎。VIVID试验是一项1期研究,评估SC262(一种HIP修饰的CD22导向同种异体CAR-T细胞疗法)在曾接受过CD19导向CAR-T治疗的复发和/或难治性B细胞恶性肿瘤患者中的应用。
In vivo
在体内
CAR T cells – SG299, which uses our fusogen platform, allows for cell-specific,
CAR T细胞 – SG299利用我们的融合平台,实现了细胞特异性,
in vivo
体内
delivery of various payloads. SG299 is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to areas such as the liver and gonadal tissue. Sana shared data showing that an SG299 surrogate with another component can lead to deep B-cell depletion in non-human primates without the use of any lymphodepleting chemotherapy.
递送各种有效载荷。SG299是一种靶向CD8的融合体,能够将制造CD19导向的CAR T细胞的遗传物质递送到CD8+ T细胞,同时避免可能有问题的递送到肝脏和生殖组织等区域。Sana分享的数据显示,在非人灵长类动物中,SG299与另一种成分结合使用可以在不使用任何淋巴清除化疗的情况下导致深度B细胞耗竭。
Sana expects to file an IND for SG299 as early as 2026, and we look forward to developing it in a range of B-cell cancers and B-cell mediated autoimmune diseases. .
Sana预计最早将在2026年为SG299提交IND申请,我们期待在一系列B细胞癌症和B细胞介导的自身免疫疾病中开发该药物。
Raised aggregate gross proceeds of approximately $105 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and equity financing in July and August 2025; expected cash runway into the second half of 2026
通过Sana的市值管理发行机制(ATM)及2025年7月和8月的股权融资,出售普通股筹集了约1.05亿美元的总收益;预计现金跑道可持续至2026年下半年。
Closed public offering in August 2025 of 20.9 million shares of Sana’s common stock and pre-funded warrants to purchase 1.5 million shares of Sana’s common stock. The gross proceeds from this offering were $75.0 million before deducting underwriting discounts and commissions and estimated offering expenses..
2025年8月,完成了公开募股,发行了2090万股Sana的普通股和可购买150万股Sana普通股的预资助认股权证。此次发行的总收益为7500万美元,尚未扣除承销折扣、佣金和估计的发行费用。
Raised gross proceeds of $29.5 million in July and August 2025 from sales of common stock through Sana’s ATM.
2025年7月和8月,通过Sana的ATM销售普通股,筹集了2950万美元的总收益。
Second Quarter 2025 Financial Results
2025年第二季度财务业绩
GAAP Results
通用会计准则结果
Cash Position
现金头寸
: Cash, cash equivalents, and marketable securities as of June 30, 2025 were $72.7 million compared to $152.5 million as of December 31, 2024. The decrease of $79.8 million was primarily driven by cash used in operations of $81.8 million.
截至2025年6月30日,现金、现金等价物和可出售证券为7,270万美元,而截至2024年12月31日为1.525亿美元。减少的7,980万美元主要是由于运营使用了8,180万美元的现金。
Research and Development Expenses
研发费用
: For the three and six months ended June 30, 2025, research and development expenses, inclusive of non-cash expenses, were $29.8 million and $67.0 million, respectively, compared to $60.9 million and $117.3 million for the same periods in 2024.The decreases of $31.1 million and $50.3 million for the three and six months ended June 30, 2025 compared to the same periods in 2024, respectively, were primarily due to lower research, laboratory, and clinical development costs related to the portfolio prioritization announced in the fourth quarter of 2024, lower personnel-related, costs, including non-cash stock-based compensation, a decrease in facility and other allocated costs primarily due to the portfolio prioritization announced in the fourth quarter of 2024, and lower third-party manufacturing costs.
截至2025年6月30日的三个月和六个月期间,包含非现金支出在内的研发费用分别为2,980万美元和6,700万美元,而2024年同期分别为6,090万美元和1亿1,730万美元。2025年截至6月30日的三个月和六个月期间较2024年同期分别减少了3,110万美元和5,030万美元,主要原因包括:2024年第四季度宣布的产品组合优先级调整导致的研究、实验室和临床开发成本下降,与人员相关的成本降低(包括非现金股权激励),因2024年第四季度宣布的产品组合优先级调整而导致的设施及其他分摊成本减少,以及第三方制造成本的降低。
Research and development expenses include non-cash stock-based compensation of $4.2 million and $8.8 million, respectively, for the three and six months ended June 30, 2025 and $7.1 million and $13.0 million for the same periods in 2024..
研发费用包括截至2025年6月30日的三个月和六个月期间分别为420万美元和880万美元的非现金股票薪酬,而2024年同期分别为710万美元和1300万美元。
Research and Development Related Success Payments and Contingent Consideration
研发相关的成功付款和或有对价
: For the three and six months ended June 30, 2025, Sana recognized non-cash expenses of $10.3 million and $12.2 million, respectively, compared to a non-cash gain of $27.9 million and a non-cash expense of $10.1 million for the same periods in 2024, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate.
截至2025年6月30日的三个月和六个月,Sana确认了1,030万美元和1,220万美元的非现金支出,而2024年同期分别为2,790万美元的非现金收益和1,010万美元的非现金支出,这些与成功付款负债和或有对价的估计公允价值变动总计相关。
The value of these potential liabilities fluctuates significantly with changes in Sana’s market capitalization and stock price..
这些潜在负债的价值会随着Sana公司市值和股价的变化而显著波动。
General and Administrative Expenses
一般及行政开支
: General and administrative expenses for the three and six months ended June 30, 2025, inclusive of non-cash expenses, were $10.3 million and $21.8 million, respectively, compared to $16.4 million and $32.7 million for the same periods in 2024. The decreases of $6.1 million and $10.9 million for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024 were primarily due to lower personnel-related costs, including non-cash stock-based compensation, due to a decrease in headcount in connection with the portfolio prioritization announced in the fourth quarter of 2024, and decreased legal and consulting fees.
截至2025年6月30日的三个月和六个月的期间,包含非现金支出在内的一般及行政费用分别为1,030万美元和2,180万美元,而2024年同期为1,640万美元和3,270万美元。相较于2024年同期,2025年截至6月30日的三个月和六个月期间分别减少了610万美元和1,090万美元,主要原因是与人员相关的成本降低,包括非现金的股权激励薪酬,这是由于2024年第四季度宣布的投资组合优先化调整导致员工人数减少,同时法律和咨询费用也有所下降。
General and administrative expenses include non-cash stock-based compensation of $2.4 million and $4.8 million for the three and six months ended June 30, 2025, respectively, compared to $4.3 million and $7.5 million for the same periods in 2024..
一般和行政费用包括截至2025年6月30日的三个月和六个月的非现金股票薪酬分别为240万美元和480万美元,而2024年同期分别为430万美元和750万美元。
Impairment of Long-Lived Assets
长期资产减值
: For the three and six months ended June 30, 2025, non-cash impairment of long-lived assets was $44.6 million, compared to zero for the same periods in 2024. The non-cash impairment was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington.
截至2025年6月30日的三个月和六个月期间,长期资产的非现金减值为4460万美元,而2024年同期则为零。该非现金减值主要与Sana位于华盛顿州博塞尔的制造工厂以及华盛顿州西雅图的某些实验室和办公空间相关。
Because of the increased availability of manufacturing capacity at third-party contract development and manufacturing organizations (CDMOs) for cell and gene therapy products as well as progress in understanding our near-term manufacturing needs, we expect to use CDMOs to meet our manufacturing needs at present and have suspended further build-out of our internal manufacturing capabilities..
由于第三方合同开发和制造组织 (CDMO) 在细胞和基因治疗产品方面的生产能力日益可用,以及我们在理解近期制造需求方面取得的进展,我们预计目前将利用 CDMO 来满足我们的生产需求,并已暂停进一步扩展内部生产能力。
Net Loss
净亏损
: Net loss for the three and six months ended June 30, 2025 was $93.8 million, or $0.39 per share, and $143.2 million, or $0.60 per share, respectively, compared to $50.3 million, or $0.21 per share, and $157.8 million, or $0.70 per share, for the same periods in 2024.
:截至 2025 年 6 月 30 日的三个月和六个月的净亏损分别为 9,380 万美元(每股 0.39 美元)和 1.432 亿美元(每股 0.60 美元),而 2024 年同期的净亏损分别为 5,030 万美元(每股 0.21 美元)和 1.578 亿美元(每股 0.70 美元)。
Non-GAAP Measures
非公认会计准则指标
Non-GAAP Operating Cash Burn
非公认会计准则运营现金消耗
: Non-GAAP operating cash burn for the six months ended June 30, 2025 was $79.0 million compared to $104.6 million for the same period in 2024. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, costs related to the portfolio prioritization in the fourth quarter of 2024 that were paid in 2025, and the purchase of property and equipment..
截至2025年6月30日的六个月内,非GAAP运营现金消耗为7900万美元,而2024年同期为1.046亿美元。非GAAP运营现金消耗是现金、现金等价物和可出售证券的减少,不包括融资活动带来的现金流入、与2024年第四季度投资组合优先化相关的成本(在2025年支付),以及购买固定资产和设备的支出。
Non-GAAP Net Loss
非公认会计准则净亏损
: Non-GAAP net loss for the three and six months ended June 30, 2025 was $38.9 million, or $0.16 per share, and $86.4 million, or $0.36 per share, respectively, compared to $74.2 million, or $0.32 per share, and $143.6 million, or $0.64 per share, for the same periods in 2024. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities, and non-cash impairment losses recorded in 2025..
非GAAP净亏损:截至2025年6月30日的三个月和六个月分别为3890万美元(每股0.16美元)和8640万美元(每股0.36美元),而2024年同期为7420万美元(每股0.32美元)和1.436亿美元(每股0.64美元)。非GAAP净亏损不包括与或有对价及成功付款负债的公允价值估计变动相关的非现金支出和收益,以及2025年记录的非现金减值损失。
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.”
下文“非公认会计原则财务指标”部分讨论了非公认会计原则指标,包括公认会计原则与非公认会计原则指标的对账。
About Sana
关于萨那
Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease.
Sana生物技术公司专注于为患者创造和提供经过工程改造的细胞作为药物。我们怀有修复和控制基因、替换缺失或受损细胞,并使我们的疗法广泛惠及患者的愿景。我们是一群充满热情的人,齐心协力打造一家改变世界治疗疾病方式的持久公司。
Sana has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA..
Sana在华盛顿州西雅图、马萨诸塞州剑桥和加利福尼亚州南旧金山开展业务。
Cautionary Note Regarding Forward-Looking Statements
关于前瞻性陈述的注意事项
This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates, and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including with respect to the substance and timing of potential INDs and potential indications for its product candidates; expectations with respect to the impact of the FDA INTERACT meeting and feedback and the ability to move forward with the Company’s HIP-edited master cell bank for GMP manufacturing and non-clinical testing plan; the potential ability to deliver on our goal of a broadly accessible single treatment with no immunosuppression leading to long-term normal blood glucose without exogenous insulin in patients with type 1 diabetes; expectations regarding the timing, substance, significance, and impact of data from clinical trials of the Company’s product candidates and technologies and an IST utilizing HIP-modified primary pancreatic islet cells, including expectations for reporting of additional data from the IST; expectations regarding the Company’s cash runway and the potential impact of the Company’s fundraising activities, including with respect to investment in the Company’s pipeline; and statements made by the Company’s President and Chief Executive Officer.
本新闻稿包含关于Sana生物技术公司(“公司”、“我们”或“我们的”)的前瞻性声明,符合联邦证券法的含义,包括与公司的愿景、进展和业务计划相关的声明;对其开发计划、候选产品和技术平台的预期,包括其临床前、临床和监管开发计划及时间预期,包括关于潜在IND的内容和时间以及其候选产品的潜在适应症;关于FDA INTERACT会议反馈的影响预期以及推进公司用于GMP生产和非临床测试计划的HIP编辑主细胞库的能力;实现我们为1型糖尿病患者提供广泛可及的单次治疗、无需免疫抑制即可长期维持正常血糖且无需外源性胰岛素的目标的潜在能力;对公司产品候选者和技术的临床试验数据的时间、内容、重要性和影响的预期,以及利用HIP修饰的原代胰岛细胞进行的IST研究,包括对IST进一步数据报告的预期;对公司现金跑道的预期及其融资活动的潜在影响,包括在公司研发管线中的投资;以及公司总裁兼首席执行官的声明。
All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-look.
本新闻稿中包含的所有非历史事实的声明,包括但不限于有关公司战略、预期、现金跑道、未来财务状况、未来运营和前景的声明,均为前瞻性声明。
Investor Relations & Media:
投资者关系与媒体:
Nicole Keith
尼科尔·基思
investor.relations@sana.com
投资者关系@sana.com
media@sana.com
媒体@sana.com
Sana Biotechnology, Inc.
赛纳生物技术公司
Unaudited Selected Consolidated Balance Sheet Data
未经审计的精选合并资产负债表数据
June 30,
6月30日,
2025
2025
December 31,
12月31日,
2024
2024
(in thousands)
(单位:千)
Cash, cash equivalents, and marketable securities
现金、现金等价物和可出售证券
$
$
72,674
72,674
$
$
152,497
152,497
Total assets
总资产
361,645
361,645
501,020
501,020
Contingent consideration
或有对价
117,132
117,132
108,968
108,968
Success payment liabilities
成功支付责任
8,611
8,611
4,556
4,556
Total liabilities
总负债
239,089
239,089
250,516
250,516
Total stockholders' equity
总股东权益
122,556
122,556
250,504
250,504
Sana Biotechnology, Inc.
赛纳生物技术公司
Unaudited Consolidated Statements of Operations
未经审计的合并经营报表
Three Months Ended June 30,
截至6月30日的三个月,
Six Months Ended June 30,
截至6月30日的六个月,
2025
2025
2024
2024
2025
2025
2024
2024
(in thousands, except per share data)
(单位:千,每股数据除外)
Operating expenses:
营业费用:
Research and development
研究与开发
$
$
29,761
29,761
$
$
60,874
60,874
$
$
66,950
66,950
$
$
117,322
十一万七千三百二十二
Research and development related success payments and contingent consideration
与研发相关的成功付款和或有对价
10,262
10,262
(27,944
(27,944
)
)
12,219
12,219
10,063
10,063
General and administrative
一般管理费用
10,341
10,341
16,442
16,442
21,825
21,825
32,711
32,711
Impairment of long-lived assets
长期资产减值
44,611
44,611
-
-
44,611
44,611
-
-
Total operating expenses
总运营费用
94,975
94,975
49,372
49,372
145,605
145,605
160,096
160,096
Loss from operations
运营亏损
(94,975
(94,975
)
)
(49,372
(49,372
)
)
(145,605
(145,605
)
)
(160,096
(160,096
)
)
Interest income, net
净利息收入
577
577
3,202
3,202
1,569
1,569
6,236
6,236
Other income (expense), net
其他收入(支出),净额
598
598
(4,121
(4,121
)
)
847
847
(3,906
(3,906
)
)
Net loss
净亏损
$
$
(93,800
(93,800
)
)
$
$
(50,291
(50,291
)
)
$
$
(143,189
(143,189
)
)
$
$
(157,766
(157,766
)
)
Net loss per common share – basic and diluted
每股普通股净亏损 - 基本和稀释
$
$
(0.39
(0.39
)
)
$
$
(0.21
(0.21
)
)
$
$
(0.60
(0.60
)
)
$
$
(0.70
(0.70
)
)
Weighted-average number of common shares – basic and diluted
加权平均普通股数量——基本和稀释
238,409
238,409
234,440
234,440
237,996
237,996
225,872
225,872
Sana Biotechnology, Inc.
赛那生物技术公司
Changes in the Estimated Fair Value of Success Payments and Contingent Consideration
成功付款及或有对价的估计公允价值变动
Success Payment
成功付款
Liability
责任
(1)
(1)
Contingent
意外事件
Consideration
考虑事项
(2)
(2)
Total Success Payment Liability and Contingent Consideration
总成功付款责任和或有对价
(in thousands)
(单位:千)
Liability balance as of December 31, 2024
截至2024年12月31日的负债余额
$
$
4,556
4,556
$
$
108,968
108,968
$
$
113,524
113,524
Changes in fair value – expense
公允价值变动 - 费用
93
93
1,864
1,864
1,957
1,957
Liability balance as of March 31, 2025
截至2025年3月31日的负债余额
4,649
4,649
110,832
十一万零八百三十二
115,481
十一万五千四百八十一
Changes in fair value – expense
公允价值变动 - 费用
3,962
3,962
6,300
6,300
10,262
10,262
Liability balance as of June 30, 2025
截至2025年6月30日的负债余额
$
$
8,611
8,611
$
$
117,132
十一万七千一百三十二
$
$
125,743
125,743
Total change in fair value for the six months ended June 30, 2025
截至2025年6月30日的六个月内公允价值的总变动
$
$
4,055
4,055
$
$
8,164
8,164
$
$
12,219
12,219
(1)
(1)
Cobalt Biomedicine, Inc. (Cobalt) and the President and Fellows of Harvard College (Harvard) are entitled to success payments pursuant to the terms and conditions of their respective agreements. The success payments are recorded at fair value and remeasured at each reporting period with changes in the estimated fair value recorded in research and development related success payments and contingent consideration on the statement of operations..
Cobalt生物医学公司(Cobalt)以及哈佛学院的校长和研究员们(哈佛)根据各自协议的条款和条件,有权获得成功付款。成功付款按公允价值记录,并在每个报告期重新计量,估计公允价值的变动记录在运营报表中的研发相关成功付款和或有对价中。
(2)
(2)
Cobalt is entitled to contingent consideration upon the achievement of certain milestones pursuant to the terms and conditions of the agreement. Contingent consideration is recorded at fair value and remeasured at each reporting period with changes in the estimated fair value recorded in research and development related success payments and contingent consideration on the statement of operations..
根据协议的条款和条件,钴公司在达成某些里程碑时有权获得或有对价。或有对价按公允价值记录,并在每个报告期重新计量,公允价值估计的变动记录在损益表中的研发相关成功付款和或有对价中。
Non-GAAP Financial Measures
非公认会计准则财务指标
To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Sana uses certain non-GAAP financial measures to evaluate its business. Sana’s management believes that these non-GAAP financial measures are helpful in understanding Sana’s financial performance and potential future results, as well as providing comparability to peer companies and period over period.
为了补充按照美国通用会计准则 (GAAP) 呈现的财务结果,Sana 使用某些非 GAAP 财务指标来评估其业务。Sana 的管理层认为,这些非 GAAP 财务指标有助于理解 Sana 的财务表现和潜在的未来结果,同时也提供了与同行公司及不同时期的可比性。
In particular, Sana’s management utilizes non-GAAP operating cash burn, non-GAAP research and development expense and non-GAAP net loss and net loss per share. Sana believes the presentation of these non-GAAP measures provides management and investors greater visibility into the company’s actual ongoing costs to operate its business, including actual research and development costs unaffected by non-cash valuation changes and certain one-time expenses for acquiring technology, as well as facilitating a more meaningful comparison of period-to-period activity.
特别是,Sana的管理层使用非GAAP经营现金消耗、非GAAP研发费用以及非GAAP净亏损和每股净亏损。Sana认为,这些非GAAP指标的展示能够为管理层和投资者提供更清晰的视角,了解公司实际持续运营成本,包括不受非现金估值变动影响的实际研发成本,以及用于获取技术的某些一次性支出,同时有助于实现期间活动更有意义的比较。
Sana excludes these items because they are highly variable from period to period and, in respect of the non-cash expenses, provides investors with insight into the actual cash investment in the development of its therapeutic programs and platform technologies..
Sana排除这些项目是因为它们在各个时期之间变化很大,而且对于非现金支出,它们为投资者提供了对其治疗计划和平台技术开发实际现金投资的洞察。
These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Sana’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting.
这些指标不应单独考虑或作为与之相当的GAAP指标的替代品,而应结合Sana根据GAAP编制的财务报表一起阅读。这些非GAAP指标虽有相同标题,但与GAAP指标有所不同,可能不同于其他公司使用的具有相同或相似标题的非GAAP财务指标,并且不反映一个全面的会计体系。
Sana’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sana’s business and make operating decisions. In addition, Sana’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sana’s results from period to period and allows for greater transparency with respect to key financial metrics Sana uses in making operating decisions.
Sana的管理层在内部使用这些补充的非GAAP财务指标来理解、管理和评估Sana的业务并作出经营决策。此外,Sana的管理层认为,这些非GAAP财务指标的列示对投资者是有用的,因为它们增强了投资者比较Sana不同期间结果的能力,并且使得Sana用于作出经营决策的关键财务指标更加透明。
The following are reconciliations of GAAP to non-GAAP financial measures:.
以下是根据公认会计原则 (GAAP) 与非公认会计原则 (non-GAAP) 财务指标的对账:。
Sana Biotechnology, Inc.
赛纳生物技术公司
Unaudited Reconciliation of Change in Cash, Cash Equivalents, and Marketable Securities to
未经审计的现金、现金等价物和可出售证券变动的对账
Non-GAAP Operating Cash Burn
非公认会计准则运营现金消耗
Six Months Ended June 30,
截至6月30日的六个月,
2025
2025
2024
2024
(in thousands)
(单位:千)
Beginning cash, cash equivalents, and marketable securities
期初现金、现金等价物和有价证券
$
$
152,497
152,497
$
$
205,195
205,195
Ending cash, cash equivalents, and marketable securities
期末现金、现金等价物和有价证券
72,674
72,674
251,643
251,643
Change in cash, cash equivalents, and marketable securities
现金、现金等价物和有价证券的变化
(79,823
(79,823
)
)
46,448
46,448
Cash paid to purchase property and equipment
购买财产和设备所支付的现金
24
24
28,901
28,901
Change in cash, cash equivalents, and marketable securities, excluding capital expenditures
现金、现金等价物和有价证券的变化,不包括资本支出
(79,799
(79,799
)
)
75,349
75,349
Adjustments:
调整:
Net proceeds from issuance of common stock
发行普通股的净收益
(254
(254
)
)
(181,029
(181,029
)
)
Cash paid for personnel-related costs incurred in connection with portfolio prioritizations
与投资组合优先排序相关的人员成本支付的现金
1,062
1,062
1,110
1,110
Operating cash burn – Non-GAAP
运营现金消耗 – 非GAAP
$
$
(78,991
(78,991
)
)
$
$
(104,570
(104,570
)
)
Sana Biotechnology, Inc.
Sana生物技术公司
Unaudited Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss Per Share
未经审计的GAAP与非GAAP净亏损及每股净亏损的调节
Three Months Ended June 30,
截至6月30日的三个月,
Six Months Ended June 30,
截至6月30日的六个月,
2025
2025
2024
2024
2025
2025
2024
2024
(in thousands, except per share data)
(单位:千,每股数据除外)
Net loss – GAAP
净亏损 – 通用会计准则
$
$
(93,800
(93,800
)
)
$
$
(50,291
(50,291
)
)
$
$
(143,189
(143,189
)
)
$
$
(157,766
(157,766
)
)
Adjustments:
调整:
Change in the estimated fair value of the success payment liabilities
成功支付负债的估计公允价值变动
(1)
(1)
3,962
3,962
(24,575
(24,575
)
)
4,055
4,055
8,048
8,048
Change in the estimated fair value of contingent consideration
或有对价估计公允价值的变动
(2)
(2)
6,300
6,300
(3,369
(3,369
)
)
8,164
8,164
2,015
2,015
Impairment of long-lived and other assets
长期资产及其他资产减值
44,611
44,611
4,069
4,069
44,611
44,611
4,069
4,069
Net loss – Non-GAAP
净亏损 – 非通用会计准则
$
$
(38,927
(38,927
)
)
$
$
(74,166
(74,166
)
)
$
$
(86,359
(86,359
)
)
$
$
(143,634
(143,634
)
)
Net loss per share – GAAP
每股净亏损 – GAAP
$
$
(0.39
(0.39
)
)
$
$
(0.21
(0.21
)
)
$
$
(0.60
(0.60
)
)
$
$
(0.70
(0.70
)
)
Adjustments:
调整:
Change in the estimated fair value of the success payment liabilities
成功付款负债的估计公允价值变动
(1)
(1)
0.01
0.01
(0.11
(0.11
)
)
0.02
0.02
0.03
0.03
Change in the estimated fair value of contingent consideration
或有对价估计公允价值的变动
(2)
(2)
0.03
0.03
(0.02
(0.02
)
)
0.03
0.03
0.01
0.01
Impairment of long-lived and other assets
长期资产及其他资产的减值
0.19
0.19
0.02
0.02
0.19
0.19
0.02
0.02
Net loss per share – Non-GAAP
每股净亏损 – 非GAAP
$
$
(0.16
(0.16
)
)
$
$
(0.32
(0.32
)
)
$
$
(0.36
(0.36
)
)
$
$
(0.64
(0.64
)
)
Weighted-average shares outstanding – basic and diluted
基本和稀释的加权平均流通股数
238,409
238,409
234,440
234,440
237,996
237,996
225,872
225,872
(1)
(1)
For the three months ended June 30, 2025, the expense related to the Cobalt success payment liability was $3.6 million compared to a gain of $20.7 million for the same period in 2024. For the six months ended June 30, 2025, the expense related to the Cobalt success payment liability was $3.7 million compared to $7.2 million for the same period in 2024 For the three months ended June 30, 2025, the expense related to the Harvard success payment liabilities was $0.4 million compared to a gain of $3.9 million for the same period in 2024.
截至2025年6月30日的三个月,与钴成功付款负债相关的费用为360万美元,而2024年同期的收益为2070万美元。截至2025年6月30日的六个月,与钴成功付款负债相关的费用为370万美元,而2024年同期为720万美元。截至2025年6月30日的三个月,与哈佛成功付款负债相关的费用为40万美元,而2024年同期的收益为390万美元。
For the six months ended June 30, 2025 the expense related to the Harvard success payment liabilities was $0.4 million compared to $0.8 million for the same period in 2024.
截至2025年6月30日的六个月内,与哈佛成功付款负债相关的费用为40万美元,而2024年同期为80万美元。
(2)
(2)
The contingent consideration is in connection with the acquisition of Cobalt.
或有对价与收购Cobalt有关。