Surrozen Provides First Quarter 2024 Financial Results and Business Update
Surrozen Provides First Quarter 2024 Financial Results and Business Update
SZN-043 Phase 1a clinical trial results to be presented at the 2024 European Association for the Study of the Liver (EASL) in Milan
SZN-043 1a 期临床试验结果将在米兰举行的 2024 年欧洲肝脏研究协会 (EASL) 上公布
Preclinical data from ARVO 2024 demonstrate the promise of a Surrozen antibody based Wnt mimetic, to activate targeted cell regeneration in cornea endothelial dystrophies and dry eye disease
来自ARVO 2024的临床前数据表明,基于Surrozen抗体的Wnt模拟剂有望激活角膜内皮营养不良和干眼病中的靶向细胞再生
SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. ("Surrozen" or the "Company") (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today provided first quarter 2024 financial results and business updates.
加利福尼亚州南旧金山,2024年5月8日(GLOBE NEWSWIRE)——Surrozen, Inc.(“Surrozen” 或 “公司”)(纳斯达克股票代码:SRZN)是一家开创选择性激活组织修复和再生Wnt途径的靶向疗法的公司,今天提供了2024年第一季度的财务业绩和业务最新情况。
"2024 is expected to be an important year focused on advancing the SZN-043 Phase 1b trial toward proof-of-concept data in patients with severe alcohol-associated hepatitis and communicating data from key R&D programs focused on Wnt modulation at upcoming medical meetings and in publications," said Craig Parker, President and Chief Executive Officer of Surrozen. "Surrozen remains driven to transform the treatment of severe diseases of the liver and eye, where we believe Wnt modulation plays an essential role."
Surrozen总裁兼首席执行官克雷格·帕克表示:“预计2024年将是重要的一年,重点是推进 SZN-043 1b期试验,以提供严重酒精相关性肝炎患者的概念验证数据,并在即将举行的医学会议和出版物中传达来自专注于Wnt调制的关键研发项目的数据。”“Surrozen仍在推动改变严重肝脏和眼部疾病的治疗方式,我们认为Wnt调节在其中起着至关重要的作用。”
Research and Development Pipeline Highlights
研发管道亮点
SZN-043
Surrozen is developing SZN-043 for severe liver disease with an initial focus in severe alcohol-associated hepatitis.
SZN-043
Surrozen 正在开发治疗严重肝病的 SZN-043,最初的重点是严重的酒精相关性肝炎。
Clinical Development Timelines/Milestones:
临床开发时间表/里程碑:
Completed Phase 1a study in healthy volunteers and chronic liver disease patients in the first quarter of 2024
Regulatory filings submitted in multiple countries for Phase 1b study and enrollment is expected to begin in the second quarter of 2024
Anticipate proof-of-concept data may be available in the first half of 2025
2024年第一季度完成了针对健康志愿者和慢性肝病患者的1a期研究
多个国家提交的1b期研究和注册监管文件预计将于2024年第二季度开始
预计概念验证数据可能在2025年上半年公布
Research Pipeline Programs and Publications
研究管道计划和出版物
Surrozen presented preclinical data at 2024 ARVO that suggests that activation of the Wnt pathway through the company's antibody based Wnt mimetic may provide a novel approach to treatment of severe eye diseases -- cornea endothelial dystrophies and dry eye disease
-
Surrozen published study in Respiratory Research demonstrating the promise of a Wnt mimetic antibody in treating pulmonary fibrosis (April, 2024:
In a preclinical model of pulmonary fibrosis, a Surrozen antibody-based SWAP platform molecule decreased pulmonary inflammation and fibrosis and improved lung function
Results highlight the potential of Wnt mimetic agonists to repair tissue after damage in severe lung diseases like idiopathic pulmonary fibrosis
Surrozen在2024年ARVO上公布了临床前数据,这些数据表明,通过该公司基于抗体的Wnt仿制剂激活Wnt途径可能为治疗严重眼部疾病(角膜内皮营养不良和干眼病)提供一种新方法
-
Surrozen在《呼吸研究》上发表的研究表明,Wnt模拟抗体有望治疗肺纤维化(2024年4月:
在肺纤维化的临床前模型中,基于Surrozen抗体的SWAP平台分子可减少肺部炎症和纤维化,改善肺功能
研究结果突显了Wnt模拟激动剂在特发性肺纤维化等严重肺部疾病损伤后修复组织的潜力
Corporate Updates
企业最新消息
Corporate Partnerships
Surrozen executed a partnership with Boehringer Ingelheim (BI) in the fourth quarter of 2022 to develop a Wnt agonist, SZN-413, for the treatment of people with retinal diseases. We anticipate the potential to nominate the lead Fzd-4 targeted Wnt agonist development candidate in 2024, which would trigger a $10.0 million milestone payment to the Company.
企业伙伴关系
Surrozen在2022年第四季度与勃林格殷格翰(BI)建立了合作伙伴关系,开发了一种用于治疗视网膜疾病患者的Wnt激动剂 SZN-413。我们预计有可能在2024年提名主要的Fzd-4靶向Wnt激动剂开发候选人,这将触发向该公司支付1,000万美元的里程碑式付款。
Financial Results for the First Quarter Ended March 31, 2024
截至2024年3月31日的第一季度财务业绩
Cash Position: Cash and cash equivalents were $27.3 million as of March 31, 2024, compared to $36.0 million as of December 31, 2023. However, inclusive of proceeds from a financing completed in April 2024, the proforma cash for March 31, 2024 would be $43.2M.
现金状况:截至2024年3月31日,现金及现金等价物为2730万美元,而截至2023年12月31日为3,600万美元。但是,包括2024年4月完成的融资的收益,2024年3月31日的预计现金将为4,320万美元。
Research and Development Expenses: Research and development expenses for the first quarter ended March 31, 2024 were $5.2 million, as compared to $8.1 million for the same period in 2023. The decreases were primarily due to the restructuring plans executed in 2023 to prioritize and focus our resources on clinical stage programs. Research and development expenses include non-cash stock-based compensation expenses of $0.3 million for the first quarter ended March 31, 2024 and the same period in 2023.
研发费用:截至2024年3月31日的第一季度的研发费用为520万美元,而2023年同期为810万美元。下降的主要原因是2023年执行的重组计划,将我们的资源优先用于临床阶段项目,并将资源集中在临床阶段项目上。研发费用包括截至2024年3月31日的第一季度以及2023年同期的30万美元非现金股票薪酬支出。
General and Administrative Expenses: General and administrative expenses for the first quarter ended March 31, 2024 were $3.9 million, as compared to $5.3 million for the same period in 2023. The decrease was primarily a result of the restructuring plans executed in 2023. General and administrative expenses include non-cash stock-based compensation expenses of $0.7 million for the first quarter ended March 31, 2024, as compared to $0.8 million for the same period in 2023.
一般和管理费用:截至2024年3月31日的第一季度的一般和管理费用为390万美元,而2023年同期为530万美元。下降的主要原因是2023年执行的重组计划。一般和管理费用包括截至2024年3月31日的第一季度70万美元的非现金股票薪酬支出,而2023年同期为80万美元。
Restructuring: Restructuring charges for the first quarter ended March 31, 2024 were zero, as compared to $1.2 million for the same period in 2023. The decrease was attributable to a restructuring plan implemented in the first quarter of 2023.
重组:截至2024年3月31日的第一季度的重组费用为零,而2023年同期为120万美元。下降归因于2023年第一季度实施的重组计划。
Interest Income: Interest income for the first quarter ended March 31, 2024 was $0.4 million, as compared to $0.5 million for the same period in 2023. The decrease was primarily related to the decrease in our money market funds and marketable securities.
利息收入:截至2024年3月31日的第一季度的利息收入为40万美元,而2023年同期为50万美元。下降主要与我们的货币市场基金和有价证券的减少有关。
Other Expense, Net: Other expense, net for the first quarter ended March 31, 2024 was $0.1 million, as compared to $0.3 million for the same period in 2023. The decrease was primarily related to the non-cash change in fair value of warrant liabilities.
其他支出净额:截至2024年3月31日的第一季度其他支出净额为10万美元,而2023年同期为30万美元。下降主要与认股权证负债公允价值的非现金变化有关。
Net Loss: Net loss for the first quarter ended March 31, 2024 was $8.8 million, as compared to $14.3 million for the same period in 2023.
净亏损:截至2024年3月31日的第一季度净亏损为880万美元,而2023年同期为1,430万美元。
About SZN-043 for Severe Alcohol-Associated Hepatitis
SZN-043 is the first development candidate using Surrozen's SWEETS technology. Surrozen is developing SZN-043 for severe liver diseases, initially focusing on alcohol-associated hepatitis. The Company has completed a Phase 1a clinical trial in patients with chronic liver disease and healthy volunteers. SZN-043 demonstrated acceptable safety and tolerability in all subjects, with evidence of target engagement, Wnt signal activation and effects on liver function. The Company is in the process of initiating enrollment in the Phase 1b clinical trial in patients with severe alcohol-associated hepatitis and expects that proof-of-concept data from this trial may be available in the first half of 2025.
关于 SZN-043 用于严重酒精相关性肝炎
SZN-043 是第一款使用 Surrozen 的 SWEETS 技术的开发候选产品。Surrozen 正在开发用于严重肝脏疾病的 SZN-043,最初的重点是酒精相关性肝炎。该公司已完成一项针对慢性肝病患者和健康志愿者的1a期临床试验。SZN-043 在所有受试者中均表现出可接受的安全性和耐受性,并有证据表明靶点接合、Wnt 信号激活以及对肝功能的影响。该公司正在启动针对严重酒精相关性肝炎患者的1b期临床试验的入组,并预计该试验的概念验证数据可能在2025年上半年公布。
About SZN-413 for Retinal Diseases
SZN-413 is a bi-specific antibody targeting Fzd4-mediated Wnt signaling designed using Surrozen's SWAP technology. It is currently being developed for the treatment of retinal vascular-associated diseases. Data generated by Surrozen with SZN-413 in preclinical models of retinopathy demonstrated that SZN-413 could potently stimulate Wnt signaling in the eye, induce normal retinal vessel regrowth, suppress pathological vessel growth and reduce vascular leakage. This novel approach could thus potentially allow for regeneration of healthy eye tissue, not only halting retinopathy, but possibly allowing for a full reversal of the patient's disease.
关于 SZN-413 用于视网膜疾病
SZN-413 是一种靶向 Fzd4 介导的 Wnt 信号传导的双特异性抗体,采用 Surrozen 的 SWAP 技术设计。目前正在开发用于治疗视网膜血管相关疾病。Surrozen 使用 SZN-413 在视网膜病变临床前模型中生成的数据表明,SZN-413 可以有效刺激眼睛中的 Wnt 信号,诱导正常的视网膜血管再生,抑制病理血管生长并减少血管泄漏。因此,这种新方法有可能使健康的眼组织再生,不仅可以阻止视网膜病变,而且有可能完全逆转患者的疾病。
In the fourth quarter of 2022, Surrozen entered into a strategic partnership with Boehringer Ingelheim for the research and development of SZN-413 for the treatment of retinal diseases. Under the terms of the agreement, Boehringer Ingelheim received an exclusive, worldwide license to develop SZN-413 and other Fzd4-specific Wnt-modulating molecules for all purposes, including as a treatment for retinal diseases, in exchange for an upfront payment to Surrozen of $12.5 million. Surrozen will also be eligible to receive up to $587.0 million in success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales. After an initial period of joint research, Boehringer Ingelheim will assume all development and commercial responsibilities.
2022年第四季度,Surrozen与勃林格殷格翰建立了战略合作伙伴关系,研究和开发用于治疗视网膜疾病的 SZN-413。根据协议条款,勃林格殷格翰获得了全球独家许可,可以开发 SZN-413 和其他 FZD4 特异性 WNT 调节分子,用于所有用途,包括用作视网膜疾病的治疗药物,以换取向 Surrozen 预付1,250万美元的款项。除了中等个位数至低两位数的销售特许权使用费外,Surrozen还有资格获得高达5.87亿美元的成功开发、监管和商业里程碑付款。经过初期的联合研究,勃林格殷格翰将承担所有开发和商业责任。
About Wnt Signaling
Wnt signaling plays key roles in the control of development, homeostasis, and regeneration of many essential organs and tissues, including liver, intestine, lung, kidney, retina, central nervous system, cochlea, bone, and others. Modulation of Wnt signaling pathways has potential for treatment of degenerative diseases and tissue injuries. Surrozen's platform and proprietary technologies have the potential to overcome the limitations in pursuing the Wnt pathway as a therapeutic strategy.
关于 Wnt Signaling
Wnt 信号传导在控制许多重要器官和组织(包括肝脏、肠、肺、肾脏、视网膜、中枢神经系统、耳蜗、骨骼等)的发育、动态平衡和再生中起着关键作用。Wnt 信号通路的调制有可能治疗退行性疾病和组织损伤。Surrozen的平台和专有技术有可能克服将Wnt途径作为治疗策略的局限性。
About Surrozen
Surrozen is a clinical stage biotechnology company discovering and developing drug candidates to selectively modulate the Wnt pathway. Surrozen is developing tissue-specific antibodies designed to engage the body's existing biological repair mechanisms with a current focus on severe liver and eye diseases. For more information, please visit .
关于 Surrozen
Surrozen是一家临床阶段的生物技术公司,正在发现和开发候选药物,以选择性地调节Wnt通路。Surrozen正在开发组织特异性抗体,旨在利用人体现有的生物修复机制,目前的重点是严重的肝脏和眼部疾病。欲了解更多信息,请访问。
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as "will," "plan," "intend," "potential," "expect," "could," or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Surrozen's discovery, research and development activities, in particular its development plans for its product candidates SZN-043 and SZN-413 (including anticipated clinical development plans and timelines, the availability of data, the potential for such product candidates to be used to treat human disease, as well as the potential benefits of such product candidates), and the Company's partnership with Boehringer Ingelheim, including the potential for future success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Surrozen and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Surrozen. These forward-looking statements are subject to a number of risks and uncertainties, including the initiation, cost, timing, progress and results of research and development activities, preclinical and clinical trials with respect to SZN-043, SZN-413 and potential future drug candidates; the Company's ability to fund its preclinical and clinical trials and development efforts, whether with existing funds or through additional fundraising; Surrozen's ability to identify, develop and commercialize drug candidates; Surrozen's ability to successfully complete preclinical and clinical studies for SZN-043, SZN-413, or other future product candidates; the effects that arise from volatility in global economic, political, regulatory and market conditions; and all other factors discussed in Surrozen's Annual Report on Form 10-K for the year ended December 31, 2023 and Surrozen's Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 to be filed with the Securities and Exchange Commission ("SEC") under the heading "Risk Factors," and other documents Surrozen has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Surrozen presently does not know, or that Surrozen currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Surrozen's expectations, plans, or forecasts of future events and views as of the date of this press release. Surrozen anticipates that subsequent events and developments will cause its assessments to change. However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Surrozen's assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
前瞻性陈述
本新闻稿包含联邦证券法所指的某些前瞻性陈述。前瞻性陈述通常附带诸如 “意愿”、“计划”、“打算”、“潜在”、“期望”、“可能” 之类的词语或这些词语的否定词以及预测或表明未来事件或趋势或非历史问题陈述的类似表达。这些前瞻性陈述包括但不限于有关Surrozen发现、研发活动的陈述,特别是其候选产品 SZN-043 和 SZN-413 的开发计划(包括预期的临床开发计划和时间表、数据的可用性、此类候选产品用于治疗人类疾病的可能性以及此类候选产品的潜在好处)的陈述,以及该公司与勃林格殷格尔海姆的合作伙伴关系,包括潜力以未来的成功为基础开发、监管和商业里程碑付款,以及中等个位数至低两位数的销售特许权使用费。这些陈述基于各种假设,无论是否在本新闻稿中提出,也基于Surrozen管理层当前的预期,不是对实际业绩的预测。这些前瞻性陈述仅用于说明目的,无意用作担保、保证、预测或对事实或概率的明确陈述,也不得将其作为担保、保证、预测或明确陈述。实际事件和情况很难或不可能预测,并且会与假设有所不同。许多实际事件和情况都超出了Surrozen的控制范围。这些前瞻性陈述受许多风险和不确定性的影响,包括与 SZN-043、SZN-413 和潜在未来候选药物相关的研发活动、临床前和临床试验的启动、成本、时机、进展和结果;公司使用现有资金或通过额外筹资为其临床前和临床试验及开发工作提供资金的能力;Surrozen识别、开发和商业化候选药物的能力;Surrozen成功完成的能力SZN-043、SZN-413 或其他未来候选产品的临床前和临床研究;全球经济、政治、监管和市场状况波动所产生的影响;以及Surrozen截至2023年12月31日止年度的10-K表年度报告和Surrozen向美国证券交易委员会(“SEC”)提交的截至2024年3月31日的季度10-Q表季度报告中讨论的所有其他因素,标题为 “风险” 因素” 以及Surrozen已经或将要向美国证券交易委员会提交的其他文件。如果这些风险中的任何一个成为现实,或者我们的假设被证明不正确,则实际结果可能与这些前瞻性陈述所暗示的结果存在重大差异。可能还有其他风险,这些风险是Surrozen目前不知道的,或者Surrozen目前认为这些风险并不重要,这些风险也可能导致实际结果与前瞻性陈述中包含的结果有所不同。此外,前瞻性陈述反映了截至本新闻稿发布之日Surrozen对未来事件和观点的预期、计划或预测。Surrozen预计,随后的事件和事态发展将导致其评估发生变化。但是,尽管Surrozen可能会选择在未来的某个时候更新这些前瞻性陈述,但除非法律要求,否则Surrozen明确表示不承担任何更新这些前瞻性陈述的义务。不应将这些前瞻性陈述作为Surrozen对本新闻稿发布之日后任何日期的评估。因此,不应过分依赖前瞻性陈述。
Investor and Media Contact:
Investorinfo@surrozen.com
投资者和媒体联系人:
Investorinfo@surrozen.com
SURROZEN, INC. |
||||||||
Three Months Ended |
||||||||
March 31, |
||||||||
2024 |
2023 |
|||||||
Operating expenses: |
||||||||
Research and development |
$ |
5,247 |
$ |
8,086 |
||||
General and administrative |
3,883 |
5,299 |
||||||
Restructuring |
— |
1,207 |
||||||
Total operating expenses |
9,130 |
14,592 |
||||||
Loss from operations |
(9,130) |
(14,592) |
||||||
Interest income |
385 |
547 |
||||||
Other expense, net |
(85) |
(252) |
||||||
Net loss |
$ |
(8,830) |
$ |
(14,297) |
||||
Net loss per share attributable to common |
$ |
(4.24) |
$ |
(7.16) |
||||
Weighted-average shares used in computing net |
2,083 |
1,998 |
SURROZEN, INC. |
||||||||
三个月已结束 |
||||||||
3月31日 |
||||||||
2024 |
2023 |
|||||||
运营费用: |
||||||||
研究和开发 |
$ |
5,247 |
$ |
8,086 |
||||
一般和行政 |
3,883 |
5,299 |
||||||
重组 |
— |
1,207 |
||||||
运营费用总额 |
9,130 |
14,592 |
||||||
运营损失 |
(9,130) |
(14,592) |
||||||
利息收入 |
385 |
547 |
||||||
其他费用,净额 |
(85) |
(252) |
||||||
净亏损 |
$ |
(8,830) |
$ |
(14,297) |
||||
归属于普通股的每股净亏损 |
$ |
(4.24) |
$ |
(7.16) |
||||
用于计算净额的加权平均份额 |
2,083 |
1,998 |
SURROZEN, INC. |
||||||||
March 31, |
December 31, |
|||||||
2024 |
2023(1) |
|||||||
(Unaudited) |
||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ |
27,290 |
$ |
36,043 |
||||
Accounts receivable |
2,128 |
2,152 |
||||||
Prepaid expenses and other current assets |
2,597 |
2,937 |
||||||
Total current assets |
32,015 |
41,132 |
||||||
Property and equipment, net |
1,584 |
1,969 |
||||||
Operating lease right-of-use assets |
1,532 |
1,889 |
||||||
Restricted cash |
688 |
688 |
||||||
Other assets |
897 |
402 |
||||||
Total assets |
$ |
36,716 |
$ |
46,080 |
||||
Liabilities and stockholders' equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ |
131 |
$ |
525 |
||||
Accrued and other liabilities |
3,485 |
4,126 |
||||||
Lease liabilities, current portion |
2,563 |
2,497 |
||||||
Total current liabilities |
6,179 |
7,148 |
||||||
Lease liabilities, noncurrent portion |
223 |
882 |
||||||
Warrant liabilities |
178 |
115 |
||||||
Total liabilities |
6,580 |
8,145 |
||||||
Stockholders' equity: |
||||||||
Preferred stock |
— |
— |
||||||
Common stock |
— |
— |
||||||
Additional paid-in-capital |
260,661 |
259,630 |
||||||
Accumulated deficit |
(230,525) |
(221,695) |
||||||
Total stockholders' equity |
30,136 |
37,935 |
||||||
Total liabilities and stockholders' equity |
$ |
36,716 |
$ |
46,080 |
SURROZEN, INC. |
||||||||
3月31日 |
十二月三十一日 |
|||||||
2024 |
2023 (1) |
|||||||
(未经审计) |
||||||||
资产 |
||||||||
流动资产: |
||||||||
现金和现金等价物 |
$ |
27,290 |
$ |
36,043 |
||||
应收账款 |
2,128 |
2,152 |
||||||
预付费用和其他流动资产 |
2,597 |
2,937 |
||||||
流动资产总额 |
32,015 |
41,132 |
||||||
财产和设备,净额 |
1,584 |
1,969 |
||||||
经营租赁使用权资产 |
1,532 |
1,889 |
||||||
受限制的现金 |
688 |
688 |
||||||
其他资产 |
897 |
402 |
||||||
总资产 |
$ |
36,716 |
$ |
46,080 |
||||
负债和股东权益 |
||||||||
流动负债: |
||||||||
应付账款 |
$ |
131 |
$ |
525 |
||||
应计负债和其他负债 |
3,485 |
4,126 |
||||||
租赁负债,流动部分 |
2,563 |
2497 |
||||||
流动负债总额 |
6,179 |
7,148 |
||||||
租赁负债,非流动部分 |
223 |
882 |
||||||
认股证负债 |
178 |
115 |
||||||
负债总额 |
6,580 |
8,145 |
||||||
股东权益: |
||||||||
优先股 |
— |
— |
||||||
普通股 |
— |
— |
||||||
额外的实收资本 |
260,661 |
259,630 |
||||||
累计赤字 |
(230,525) |
(221,695) |
||||||
股东权益总额 |
30,136 |
37,935 |
||||||
负债和股东权益总额 |
$ |
36,716 |
$ |
46,080 |
译文内容由第三方软件翻译。