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生物制药公司VBI Vaccines公布2024年第一季度财务业绩

VBI Vaccines Reports First Quarter 2024 Financial Results

businesswire 等信源发布 2024-05-16 02:00

可切换为仅中文


CAMBRIDGE, Mass.--(BUSINESS WIRE)--VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended March 31, 2024.

马萨诸塞州剑桥市。-(商业新闻短讯)--VBI疫苗公司(纳斯达克:VBIV)(VBI)是一家以免疫学为驱动力的生物制药公司,致力于强大的疾病预防和治疗,今天提供了最新的商业信息,并公布了截至2024年3月31日的季度财务报表。

“To date in 2024, our focus has centered around pipeline execution, expanding access and increased uptake of PreHevbrio in targeted market segments, and execution of strategic partnerships to drive opportunity for our portfolio assets, create shareholder value, and strengthen our balance sheet,” said Jeff Baxter, VBI’s President and CEO.

VBI总裁兼首席执行官杰夫·巴克斯特(Jeff Baxter)表示:“到2024年为止,我们的重点一直集中在管道执行、扩大目标细分市场对PreHevbrio的访问和增加吸收,以及执行战略合作伙伴关系,以推动我们投资组合资产的机会,创造股东价值,并加强我们的资产负债表。”。

“We remain committed to creating opportunities for our vaccines, candidates, and technologies to meaningfully impact public health and the lives of patients, providers, and families.”.

“我们仍然致力于为我们的疫苗、候选人和技术创造机会,以有意义地影响公共卫生以及患者、提供者和家庭的生活。”。

Recent Key Program Achievements and Projected Upcoming Milestones

最近的关键项目成就和预计即将到来的里程碑

PreHevbrio® [Hepatitis B Vaccine (Recombinant)]

PreHevbrio®[乙型肝炎疫苗(重组)]

Product revenue, net increased 105% from Q1 2023, with $1.0 million earned in Q1 2024

产品收入较2023年第一季度净增长105%,2024年第一季度收入100万美元

US:

美国:

H1 2024 PreHevbrio U.S. sales continue to demonstrate substantial growth over 2023, with over 80% of the 2023 full-year volume being sold in the first five months of 2024

2024年上半年,PreHevbrio美国销售额在2023年期间继续大幅增长,2023年全年销售额的80%以上在2024年前五个月售出

Commercial execution in Q1 2024 created new demand in the large Integrated Delivery Network (IDN) and hospital system space, and saw continued national and regional pharmacy uptake

2024年第1季度的商业执行为大型综合交付网络(IDN)和医院系统空间创造了新的需求,并见证了国家和地区药房的持续发展

Public sector momentum building with PreHevbrio now available for purchase under the CDC Adult Vaccine Contract

根据CDC成人疫苗合同,公共部门与PreHevbrio的势头建设现已可供购买

Ex-US – PreHevbri®:

Ex US–PreHevbri®:

VBI partners with Valneva SE to make PreHevbri available in certain European countries

VBI与Valneva SE合作,在某些欧洲国家提供PreHevbri

In 2023, through this partnership, PreHevbri was launched in the UK, Sweden, Netherlands, and Belgium – in early 2024, PreHevbri also became available in Denmark and Norway

2023年,通过这一合作关系,PreHevbri在英国、瑞典、荷兰和比利时推出——2024年初,PreHevbri也在丹麦和挪威推出

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate – Glioblastoma (GBM)

VBI-1901:癌症疫苗免疫治疗候选药物-胶质母细胞瘤(GBM)

VBI-1901 is being evaluated in an ongoing, randomized, controlled Phase 2b study in comparison to standard-of-care chemotherapy treatment in recurrent GBM patients

VBI-1901正在一项正在进行的随机对照2b期研究中进行评估,与复发性GBM患者的标准化疗治疗进行比较

April 2024: Encouraging early tumor response data from Phase 2b study in recurrent GBM presented at World Vaccine Congress 2024:

2024年4月:在2024年世界疫苗大会上提交的复发性GBM 2b期研究的早期肿瘤反应数据令人鼓舞:

VBI-1901 Arm: 2 stable disease (SD) observations among patients eligible for evaluation at week 12 (n=2/5), achieving a 40% disease control rate, consistent with 44% disease control rate observed in the Phase 1/2a portion of the study

VBI-1901组:在第12周(n=2/5)有资格接受评估的患者中观察到2个稳定的疾病(SD),疾病控制率达到40%,与研究1/2a期观察到的44%疾病控制率一致

Control Arm (carmustine or lomustine chemotherapy): No tumor responses have been observed to date (n=0/6; 0% disease control rate) – all evaluable patients experienced a 2-8x increase in tumor size by week 6 and have been taken off study protocol

对照组(卡莫司汀或洛莫司汀化疗):迄今为止尚未观察到肿瘤反应(n=0/6;疾病控制率为0%)–所有可评估的患者在第6周时肿瘤大小均增加了2-8倍,并已停止研究方案

Mid-Year 2024 and Year-End: Additional tumor response data from ongoing Phase 2b study expected mid-year 2024, with initial survival data from early-enrolled participants expected by year-end 2024, subject to speed of enrollment

2024年年中和年底:正在进行的2b期研究的其他肿瘤反应数据预计将在2024年年中发布,早期登记参与者的初始生存数据预计将在2024年年底发布,具体取决于登记速度

Novel mRNA-Launched eVLP (MLE) Technology Platform

新型mRNA启动的eVLP(MLE)技术平台

April 2024: Announced expansion of strategic partnership with the Canadian Government to advance the development of the MLE technology platform, supported by the CAD$28 million funding award remaining under the original agreement

2024年4月:宣布扩大与加拿大政府的战略合作伙伴关系,以推进MLE技术平台的开发,并得到原始协议下剩余的2800万加元资金的支持

Throughout 2024: MLE technology remains under active evaluation by potential partners

2024年全年:MLE技术仍在潜在合作伙伴的积极评估中

Other Achievements and Upcoming Milestones

其他成就和即将到来的里程碑

February 2024: Announced a series of agreements with Brii Biosciences (“Brii Bio”), pursuant to which, subject to achievement of certain activities, VBI would receive up to $33 million in consideration for VBI’s manufacturing capabilities and certain related assets at Rehovot manufacturing facility, the intellectual property for VBI-2601, VBI’s hepatitis B immunotherapeutic candidate, and a license for VBI-1901 in the Asia Pacific region, excluding Japan.

2024年2月:宣布了与Brii Biosciences(“Brii Bio”)的一系列协议,根据该协议,在完成某些活动的情况下,VBI将获得3300万美元,以换取VBI的制造能力和Rehovot制造厂的某些相关资产,VBI-2601的知识产权,VBI的乙型肝炎免疫治疗候选物,以及VBI-1901在亚太地区(不包括日本)的许可证。

Following completion of the full transaction, target mid-year 2024, VBI expects its total debt principal to be significantly reduced to $17 million

在完成全部交易(目标为2024年年中)后,VBI预计其总债务本金将大幅减少至1700万美元

2024: Additional data expected from Phase 1 study of VBI-2901, VBI’s multivalent pan-coronavirus vaccine candidate – initial data from which were reported in September 2023

2024年:预计VBI-2901(VBI的多价泛冠状病毒候选疫苗)的第一阶段研究将提供更多数据-最初数据于2023年9月报告

Recent Peer-Reviewed Publications

最近的同行评审出版物

Langley, Gantt, et al., “An enveloped virus-like particle alum-adjuvanted cytomegalovirus vaccine is safe and immunogenic: A first-in-humans Canadian Immunization Research Network (CIRN) study” published in Vaccine – Link Here

Langley,Gantt等人,“包膜病毒样颗粒明矾佐剂巨细胞病毒疫苗安全且具有免疫原性:加拿大免疫研究网络(CIRN)首次人体研究”,发表在疫苗链接上

Financial Results for the Three Months Ended March 2024

截至2024年3月的三个月财务业绩

Cash Position: As of March 31, 2024 VBI had $12.6 million in cash as compared with $23.7 million in cash as of December 31, 2023. Cash position at March 31, 2024, does not include approximately $2.8 million gross proceeds from registered direct offering of common shares and warrants, warrant exercises, and sale of common shares through VBI’s at-the-market facility with Jefferies LLC, subsequent to March 31, 2024 and through early April 2024..

现金状况:截至2024年3月31日,VBI拥有1260万美元现金,而截至2023年12月31日,VBI拥有2370万美元现金。截至2024年3月31日的现金状况不包括2024年3月31日之后至2024年4月初,通过VBI在Jefferies LLC的市场设施直接发行普通股和认股权证、认股权证行权以及出售普通股产生的约280万美元总收益。。

Revenues, net: Revenues, net for the first quarter 2024 were $1.2 million as compared to $0.5 million for the same period in 2023. The revenue increase was a result of an increase in product sales of PreHevbrio in the U.S.

净收入:2024年第一季度的净收入为120万美元,而2023年同期为50万美元。收入的增加是PreHevbrio在美国的产品销售额增加的结果。

Cost of Revenues: Cost of revenues was $2.7 million in the first quarter of 2024 as compared to $3.6 million in the first quarter of 2023. The decrease in the cost of revenues was a result of the April 2023 organizational changes and decreased inventory-related costs, offset by increased product sales..

收入成本:2024年第一季度的收入成本为270万美元,而2023年第一季度为360万美元。收入成本的下降是2023年4月组织变革和库存相关成本下降的结果,被产品销售额的增加所抵消。。

Research and Development (R&D): R&D expenses for the first quarter of 2024 were $2.6 million as compared to $3.2 million for the same period in 2023. R&D expenses were offset by $0.7 million for the three months ended March 31, 2024, and $2.4 million for the three months ended March 31, 2023 due to government grants and funding arrangements.

研发(R&D):2024年第一季度的研发费用为260万美元,而2023年同期为320万美元。由于政府拨款和资金安排,截至2024年3月31日的三个月内研发费用抵消了70万美元,截至2023年3月31日的三个月内抵消了240万美元。

The decrease in R&D expenses is primarily a result of decreased development expenses for VBI’s pan-coronavirus and GBM candidates, VBI-2901 and VBI-1901, due to timing of ongoing clinical studies of each candidate..

研发费用的减少主要是由于VBI的泛冠状病毒和GBM候选者VBI-2901和VBI-1901的开发费用减少,这是由于每个候选者正在进行临床研究的时间安排所致。。

Sales, General, and Administrative (SG&A): SG&A expenses for the first quarter of 2024 were $7.7 million as compared to $13.3 million in the first quarter of 2023. The decrease in SG&A expenses was mainly a result of the April 2023 organizational changes that reduced our internal workforce, commercial field teams, and operating expenses..

销售、总务和管理(SG&A):2024年第一季度的SG&A费用为770万美元,而2023年第一季度为1330万美元。SG&A费用的减少主要是由于2023年4月的组织变革减少了我们的内部劳动力、商业现场团队和运营费用。。

Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2024 was $11.8 million compared to $21.7 million for the same period in 2023. The 46% decrease in cash outflows is largely due to a decrease in net loss as a result of the April 2023 organizational changes, in addition to the change in operating working capital, most notably in inventory, other current assets, accounts payable, and other current liabilities..

用于经营活动的净现金:2024年第一季度用于经营活动的净现金为1180万美元,而2023年同期为2170万美元。现金流出减少46%主要是由于2023年4月的组织变革导致净亏损减少,此外还有营运资本的变化,尤其是存货、其他流动资产、应付账款和其他流动负债。。

Net Loss and Net Loss Per Share: Net loss and net loss per share for the first quarter of 2024 were $17.9 million and $0.73, respectively, as compared to a net loss and net loss per share of $27.8 million and $3.22 for the first quarter of 2023, respectively.

每股净亏损和净亏损:2024年第一季度的每股净亏损和净亏损分别为1790万美元和0.73美元,而2023年第一季度的每股净亏损和净亏损分别为2780万美元和322美元。

Net Loss and Net Loss Per Share, Excluding Foreign Exchange Loss: Net loss and net loss per share, excluding foreign exchange loss, for the first quarter 2024 were $13.6 million and $0.55, respectively, compared to $20.9 million and $2.43 for the first quarter 2023, respectively. See “Use of Non-GAAP Financial Measures” below for additional information regarding this non-GAAP financial measure, and “GAAP to Non-GAAP Reconciliation” for a reconciliation of this non-GAAP financial measure to net loss and net loss per share..

不包括外汇损失的每股净损失和净损失:2024年第一季度不包括外汇损失的每股净损失和净损失分别为1360万美元和0.55美元,而2023年第一季度分别为2090万美元和243美元。有关此非GAAP财务指标的更多信息,请参阅下面的“非GAAP财务指标的使用”,以及将此非GAAP财务指标与净损失和每股净损失进行对账的“GAAP与非GAAP对账”。。

Foreign exchange loss for the first quarter of 2024 was $4.3 million as compared to $6.8 million for the first quarter of 2023. Certain intercompany loans between the Company and its subsidiaries are denominated in a currency other than the functional currency of each entity. The decrease in foreign exchange loss was a result of the changes in the foreign currency exchange rates (of the New Israeli Shekel and the Canadian Dollar) in which the foreign currency transactions were denominated for each of those periods, including the foreign exchange impact of intercompany loans that are translated at period end..

2024年第一季度的外汇损失为430万美元,而2023年第一季度为680万美元。公司与其子公司之间的某些公司间贷款以各实体功能货币以外的货币计价。外汇损失的减少是由于(新的以色列谢克尔和加元)外币汇率的变化,其中外币交易是在这些期间的每一个期间计价的,包括期末折算的公司间贷款的外汇影响。。

Use of Non-GAAP Financial Measures

非GAAP财务指标的使用

Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are non-GAAP financial measures and are defined as Net Loss and Net Loss Per Share excluding the foreign exchange loss in both calculations. Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are not intended to replace Net Loss or Net Loss Per Share or other measures of financial performance reported in accordance with generally accepted accounting principles (GAAP).

不含外汇损失的净损失和不含外汇损失的每股净损失是非GAAP财务指标,在两种计算中均定义为不含外汇损失的每股净损失和净损失。净损失(不包括外汇损失)和每股净损失(不包括外汇损失)并不意味着替代净损失或每股净损失或根据公认会计原则(GAAP)报告的其他财务业绩指标。

VBI’s management believes that the presentation of Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are useful to investors because management does not consider foreign exchange loss, which is primarily driven by changes in exchange rates related to certain intercompany loans, and is a non-recurring item, when evaluating VBI’s operating performance.

VBI的管理层认为,净损失(不包括外汇损失)和每股净损失(不包括外汇损失)的列报对投资者很有用,因为管理层在评估VBI的经营业绩时不考虑外汇损失,外汇损失主要由某些公司间贷款的汇率变化驱动,并且是非经常性项目。

Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. The presentation of these non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company’s financial statements prepared in accordance with GAAP.

非GAAP财务指标旨在补充GAAP财务结果,并与之结合使用。这些非公认会计准则财务指标的列报不应单独考虑,也不应替代可比的公认会计准则财务指标,只能与根据公认会计准则编制的公司财务报表一起阅读。

Reconciliations of the Company’s non-GAAP measures are included below..

本公司非公认会计原则措施的对账如下。。

The following represents a reconciliation of Net Loss to Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share to Net Loss Per Share, Excluding Foreign Exchange Loss. See “Non-GAAP Financial Information” below for additional information regarding this non-GAAP financial measure, and “GAAP to Non-GAAP Reconciliation” for a reconciliation of this non-GAAP financial measure to net loss and net loss per share..

以下是净损失与净损失(不包括外汇损失)以及每股净损失与每股净损失(不包括外汇损失)的对账。有关此非GAAP财务指标的更多信息,请参阅下文的“非GAAP财务信息”,以及将此非GAAP财务指标与净损失和每股净损失进行对账的“GAAP与非GAAP对账”。。

GAAP to Non-GAAP Reconciliations

GAAP与非GAAP对账

The following represents a reconciliation of Net Loss to Net Loss Excluding Impairment Charges and Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss.

以下是净损失与净损失的对账,不包括减值费用和外汇损失,每股净损失不包括外汇损失。

Three Months Ended March 31

截至3月31日的三个月

2024

2024

2023

2023

(Unaudited)

(未经审计)

(In 000’s except share and per share amounts)

(除股份和每股金额外,单位为000)

Net Loss

净损失

$

$

(17,900

(17,900

)

)

$

$

(27,751

(27,751

)

)

Foreign exchange loss

外汇损失

4,330

4,330

6,813

6,813

Net loss, excluding impairment charges and foreign exchange loss

净损失,不包括减值费用和外汇损失

$

$

(13,570

(13,570

)

)

$

$

(20,938

(20,938

)

)

Weighted-average number of shares

加权平均股数

24,584,798

24,584,798

8,608,539

8,608,539

Net loss per share, excluding impairment charges and foreign exchange loss

每股净损失,不包括减值费用和外汇损失

$

$

(0.55

(0.55

)

)

$

$

(2.43

(2.43

)

)

About PreHevbrio [Hepatitis B Vaccine (Recombinant)]

关于PreHevbrio[乙型肝炎疫苗(重组)]

PreHevbrio is the only 3-antigen hepatitis B vaccine, comprised of the three surface antigens of the hepatitis B virus – Pre-S1, Pre-S2, and S. It is approved for use in the U.S., European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio® (US/Canada), PreHevbri® (EU/EEA/UK), and Sci-B-Vac® (Israel)..

PreHevbrio是唯一的三抗原乙型肝炎疫苗,由乙型肝炎病毒的三种表面抗原Pre-S1,Pre-S2和S组成。它被批准用于美国,欧盟/欧洲经济区,英国,加拿大和以色列。该疫苗的品牌名称为:PreHevbrio®(美国/加拿大),PreHevbri®(欧盟/欧洲经济区/英国)和Sci-B-Vac®(以色列)。。

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

有关PreHevbrio[乙型肝炎疫苗(重组)]的美国重要安全信息,请访问www.PreHevbrio.com,或参阅美国完整的处方信息。

U.S. Indication

U、 S.指示

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

PreHevbrio用于预防由所有已知的乙型肝炎病毒亚型引起的感染。PreHevbrio被批准用于18岁及以上的成年人。

U.S. Important Safety Information (ISI)

U、 美国重要安全信息(ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

不要对先前接种过乙型肝炎疫苗或任何PreHevbrio成分的有严重过敏反应(例如过敏反应)史的个体服用PreHevbrio。

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

在服用PreHevbrio后,必须提供适当的医疗和监督来管理可能的过敏反应。

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

免疫功能低下的人,包括那些接受免疫抑制剂治疗的人,可能对PreHevbrio的免疫反应减弱。

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

PreHevbrio可能无法预防接种疫苗时未被识别的乙型肝炎感染者的乙型肝炎感染,而乙型肝炎的潜伏期很长。

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

在18-44岁的成年人,45-64岁的成年人和65岁以上的成年人中,最常见的副作用(>10%)是注射部位的疼痛和压痛,肌痛,疲劳和头痛。

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

有一个妊娠暴露登记处,用于监测怀孕期间接受PreHevbrio的女性的妊娠结局。鼓励怀孕期间接受PreHevbrio的女性联系1-888-421-8808(免费电话)。

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

要报告疑似不良反应,请联系VBI疫苗,电话1-888-421-8808(免费),或联系VAERS,电话1-800-822-7967或www.VAERS.hhs.gov。

Please see Full Prescribing Information.

请参阅完整的处方信息。

About VBI Vaccines Inc.

关于VBI疫苗公司。

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology and a proprietary mRNA-launched eVLP (“MLE”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system.

VBI疫苗公司(“VBI”)是一家由免疫学推动的生物制药公司,致力于强大的疾病预防和治疗。通过其对病毒样颗粒(“VLP”)的创新方法,包括专有的包膜VLP(“eVLP”)平台技术和专有的mRNA启动eVLP(“MLE”)平台技术,VBI开发了模仿病毒自然呈现的候选疫苗,旨在激发人类免疫系统的先天力量。

VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel..

VBI致力于针对和克服重大传染病,包括乙型肝炎,冠状病毒和巨细胞病毒(CMV),以及侵袭性癌症,包括胶质母细胞瘤(GBM)。VBI总部位于马萨诸塞州剑桥市,在加拿大渥太华设有研究机构,在以色列雷霍沃特设有研究和制造基地。。

Website Home: http://www.vbivaccines.com/

网站主页:http://www.vbivaccines.com/

News and Resources: http://www.vbivaccines.com/news-and-resources/

News and Resources: http://www.vbivaccines.com/news-and-resources/

Investors: http://www.vbivaccines.com/investors/

Investors: http://www.vbivaccines.com/investors/

Cautionary Statement on Forward-looking Information

前瞻性信息警示声明

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”).

本新闻稿中的某些前瞻性声明而非历史事实声明是1995年《私人证券诉讼改革法案》安全港条款所指的前瞻性声明,也是加拿大证券法所指的前瞻性信息(统称“前瞻性声明”)。

The Company cautions that such forward-looking statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management.

公司警告称,此类前瞻性陈述涉及可能对公司经营业绩产生重大影响的风险和不确定性。此类前瞻性陈述基于管理层的信念以及管理层做出的假设和目前可获得的信息。

Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the Company’s ability to regain and maintain compliance with the listing standards of the Nasdaq Capital Market, the Company’s ability to satisfy all of the conditions to the consummation of the transactions with Brii Biosciences, the Company’s ability to comply with its obligations under its loan agreement with K2 HealthVentures, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the COVID-19 endemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market p.

由于某些因素,实际结果可能与前瞻性声明所预期的结果存在重大差异,包括但不限于公司恢复并保持符合纳斯达克资本市场上市标准的能力,公司满足与Brii Biosciences完成交易的所有条件的能力,公司遵守其与K2 HealthVentures贷款协议项下义务的能力,美国或国际上一般经济、行业或政治条件的影响;新型冠状病毒流行对我们的临床研究,制造,商业计划和全球经济的影响;成功制造和商业化PreHevbrio/PreHevbri的能力;在临床前或临床试验中确定潜在产品有效或安全的能力;在候选管道开发和PreHevbrio/PreHevbri商业化方面建立或保持合作的能力;能够获得适当或必要的监管部门批准以推广p。

VBI Vaccines Inc. and Subsidiaries

VBI疫苗公司及其子公司

Selected Condensed Consolidated Balance Sheet

选定的简明合并资产负债表

(Unaudited, In Thousands)

(未经审计,单位:千)

Three Months Ended March 31

截至3月31日的三个月

2024

2024

2023

2023

(Unaudited)

(未经审计)

(In 000’s except share and per share amounts)

(除股份和每股金额外,单位为000)

Assets

资产

Cash

现金

$

$

12,595

12,595

$

$

23,685

23,685

Accounts receivable, net

应收账款净额

227

227

-

-(笑声)

Inventory, net

库存,净额

9,944

9,944

8,499

8,499

Prepaid expenses and other current assets

预付费用和其他流动资产

3,595

3,595

4,047

4,047

Total current assets

流动资产总额

26,361

26,361

36,231

36,231

Property and equipment, net

财产和设备净值

9,088

9,088

9,665

9,665

Intangible assets, net

无形资产净值

35,734

35,734

36,499

36,499

Goodwill

商誉

1,107

1,107

1,130

1,130

Other non-current assets

其他非流动资产

3,153

3,153

3,426

3,426

Total Assets

总资产

$

$

75,443

75,443

$

$

86,951

86,951

Liabilities and stockholders’ equity

负债和股东权益

Accounts payable

应付账款

$

$

8,871

8,871

$

$

6,431

6,431

Other current liabilities

其他流动负债

68,723

68,723

69,305

69,305

Total current liabilities

流动负债合计

77,594

77,594

75,736

75,736

Total non-current liabilities

非流动负债合计

3,316

3,316

3,688

3,688

Total liabilities

负债总额

80,910

80,910

79,424

79,424

Total stockholders' equity

股东权益合计

(5,467

(5,467

)

)

7,527

7,527

Total liabilities and stockholders' equity

总负债和股东权益

$

$

75,443

75,443

$

$

86,951

86,951

VBI Vaccines Inc. and Subsidiaries

VBI疫苗公司及其子公司

Condensed Consolidated Statement of Operations and Comprehensive Loss

简明综合经营报表和综合损失

(Unaudited, In Thousands Except Share and Per Share Amounts)

(未经审计,单位为千,股份和每股金额除外)

Three Months Ended March 31

截至3月31日的三个月

2024

2024

2023

2023

(Unaudited)

(未经审计)

Revenues, net

净收入

$

$

1,214

1,214

$

$

485

485

Operating expenses

营业费用

Cost of revenues

收入成本

2,724

2,724

3,559

3,559

Research and development

研究与开发

2,571

2,571

3,151

3,151

Sales, general, and administrative

销售、一般和管理

7,671

7,671

13,284

13,284

Total operating expenses

营业费用合计

12,966

12,966

19,994

19,994

Loss from operations

运营损失

(11,752

(11,752

)

)

(19,509

(19,509

)

)

Interest expense, net of interest income

利息支出,利息收入净额

(1,818

(1,818

)

)

(1,429

(1,429

)

)

Foreign exchange loss

外汇损失

(4,330

(4,330

)

)

(6,813

(6,813

)

)

Loss before income taxes

所得税前亏损

(17,900

(17,900

)

)

(27,751

(27,751

)

)

Income tax benefit

所得税福利

-

-(笑声)

-

-(笑声)

Net Loss

净损失

$

$

(17,900

(17,900

)

)

$

$

(27,751

(27,751

)

)

Basic and diluted net loss per share

每股基本和稀释净亏损

$

$

(0.73

(0.73

)

)

$

$

(3.22

(3.22

)

)

Weighted-average number of shares used to compute basic and diluted net loss per share

用于计算每股基本净损失和稀释净损失的加权平均股数

24,584,798

24,584,798

8,608,539

8,608,539

Other comprehensive income

其他综合收益

3,484

3,484

6,599

6,599

Comprehensive Loss

综合损失

$

$

(14,416

(14,416

)

)

$

$

(21,152

(21,152

)

)