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Reviva宣布根据纳斯达克规则在市场上进行3000万美元的注册直接发行

Reviva Announces $30 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

BioSpace 等信源发布 2023-11-16 20:29

可切换为仅中文


CUPERTINO, Calif., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that it has entered into definitive agreements with several healthcare-focused institutional investors, and an investment vehicle managed by a firm affiliated with a member of the Company’s Board of Directors, for the sale and issuance of 5,853,660 shares of the Company’s common stock (or prefunded warrants in lieu thereof) and warrants to purchase up to 5,853,660 shares of common stock at a combined offering price of $5.125 per share of common stock (or prefunded warrant in lieu thereof) and accompanying warrant in a registered direct offering priced at-the-market under the Nasdaq rules.

2023年11月16日(GLOBE NEWSWIRE)-Reviva Pharmaceuticals Holdings,Inc。(纳斯达克股票代码:RVPH)(“Reviva”或“公司”),这是一家开发治疗方法的后期制药公司,旨在解决中枢神经系统(CNS),炎症和心脏代谢疾病领域未满足的医疗需求,今天宣布,它已与多家以医疗保健为重点的机构投资者达成明确协议,以及由隶属于公司董事会成员的公司管理的投资工具,出售及发行本公司普通股5853660股股份(或代替其预售认股权证)及认股权证,以普通股5.125美元的综合发行价购买多达5853660股普通股股份(或代替普通股优先认股权证))及随附认股权证,根据纳斯达克规则在市场上定价的登记直接发行。

The warrants have an exercise price of $5.00 per share, will be immediately exercisable and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about November 20, 2023, subject to the satisfaction of customary closing conditions..

认股权证行使价为每股5.00美元,将立即行使,并于发行日期后五年到期。在满足习惯性结算条件的前提下,预计将于2023年11月20日或之后结束发行。。

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

H、 C.Wainwright&Co。是该产品的独家发行代理。

The gross proceeds to Reviva from this offering are expected to be approximately $30,000,000, before deducting the placement agent’s fees and other offering expenses. Reviva intends to use the net proceeds from this offering, together with its existing cash and cash equivalents, to fund research and development activities, including the registrational Phase 3 RECOVER-2 trial and other clinical and regulatory development and the continued development of Reviva’s product candidates and for working capital and other general corporate purposes.

在扣除安置代理人的费用和其他提供费用之前,本次发行Reviva的总收益预计约为30000000美元。Reviva打算利用本次发行的净收益及其现有现金和现金等价物为研究和开发活动提供资金,包括注册第3阶段RECOVER-2试验和其他临床和监管开发以及Reviva候选产品的持续开发。用于营运资本和其他一般公司用途。

Reviva may also use a portion of the net proceeds and its existing cash and cash equivalents for acquisitions or investments in businesses, products or technologies that are complementary to its own. However, Reviva currently does not have agreements or commitments to complete any such transaction..

Reviva还可以使用净收益的一部分及其现有现金和现金等价物来收购或投资与其自身互补的业务,产品或技术。但是,Reviva目前没有完成任何此类交易的协议或承诺。。

The securities described above are being offered pursuant to a “shelf” registration statement (File No. 333-262348) that was filed with the Securities and Exchange Commission (“SEC”) on January 26, 2022 and was declared effective on February 2, 2022. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement.

上述证券是根据2022年1月26日提交给证券交易委员会(“SEC”)的“货架”注册声明(文件号333-262348)提供的,并于2月2日宣布生效,2022年。证券的发行仅通过IPO(包括IPO补充)进行,这是有效注册声明的一部分。

A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com..

与该发行有关的承销说明书补充资料及随附的承销说明书将向证券交易委员会提交。如果有的话,可以在证券交易委员会网站www.SEC.gov上或通过联系H.C.Wainwright&Co.,LLC位于纽约州10022年3楼430 Park Avenue,电话(212)856-5711或电子邮件placements@hcwco.com..

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction..

本新闻稿不得构成出售或征求购买这些证券的报价,也不得在任何国家或管辖区销售这些证券,在这些报价,征求或销售在任何此类州或管辖区的证券法下注册或鉴定之前是非法的。。

About Brilaroxazine

关于布里拉嗪

Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs.

Brilaroxazine是一种内部发现的新化学实体,对涉及精神分裂症及其合并症的关键5-羟色胺和多巴胺受体具有有效的亲和力和选择性。来自全球第3阶段RECOVER精神分裂症试验的阳性数据表明,该试验成功地满足了所有主要和次要终点,在第4周时所有主要症状领域的统计学显着和临床意义上的减少与50毫克brilaroxazine vs。

placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor.

安慰剂具有通常良好耐受的副作用特征,与安慰剂相当,停药率低于安慰剂。来自临床药物-药物相互作用(DDI)研究的阳性数据研究了CYP3A4酶对健康受试者中brilaroxazine的潜在影响,当与CYP3A4抑制剂组合时,不支持临床上显着的相互作用。

Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD)..

Reviva认为,brilaroxazine已经完成了一整套符合法规的毒理学和安全药理学研究。Reviva打算开发brilaroxazine用于其他神经精神适应症,包括双相情感障碍,重度抑郁症(MDD)和注意力缺陷/多动障碍(ADHD)。。

Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S.

此外,brilaroxazine已显示出对炎症性疾病牛皮癣,肺动脉高压(PAH)和特发性肺纤维化(IPF)有希望的非临床活性,并在转化动物模型中减轻纤维化和炎症。Brilaroxazine已经获得美国的孤儿药指定。

FDA for the treatment of PAH and IPF conditions..

FDA用于治疗PAH和IPF病症。。

To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.

要了解有关brilaroxazine的临床和临床前数据的更多信息,请访问revivapharma.com/publications。

About Reviva

关于Reviva

Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system, respiratory and metabolic diseases.

Reviva是一家后期生物制药公司,发现,开发和寻求将代表未满足医疗需求和社会,患者及其家属负担的疾病的下一代治疗药物商业化。Reviva目前的管道专注于中枢神经系统,呼吸系统和代谢疾病。

Reviva’s pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries..

Reviva的管道目前包括两种候选药物,brilaroxazine(RP5063)和RP1208。两者都是内部发现的新化学实体。Reviva已在美国,欧洲和其他几个国家获得brilaroxazine和RP1208的物质专利组成。。

Forward-Looking Statements

前瞻性声明

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the offering, the satisfaction of the closing conditions of the offering, the closing of the offering, the amount and anticipated use of proceeds from the offering, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including, product development, clinical and regulatory timelines and expenses, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature.

本新闻稿包含1933年“证券法”第27A条和1934年“证券交易法”第21E条以及经修订的“私人证券诉讼改革法”含义内的某些前瞻性声明,包括与该产品有关的,对产品关闭条件的满意度,产品关闭,产品收益的数量和预期用途,公司对其产品候选人预期临床表现的期望,包括有关预期功效或安全性的声明,以及与公司对产品开发,临床和监管时间表和费用,市场机会,筹集足够资金的能力,竞争地位,可能或假设的未来运营结果,商业策略,潜在的增长机会以及其他具有预测性的陈述。

These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions..

这些前瞻性陈述基于对我们经营的行业和市场的当前预期,估计,预测和预测以及管理层当前的信念和假设。。

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

这些陈述可以通过使用前瞻性表达来确定,包括但不限于“期望”,“预期”,“意图”,“计划”,“相信”,“估计”,“潜力”,“预测”,“项目”,“应该”以及这些条款的类似表达和否定。这些陈述涉及未来事件或我们的财务业绩,涉及已知和未知的风险,不确定性以及可能导致实际结果,业绩或成就与任何未来结果,业绩或成就表达或暗示的任何未来成果,业绩或成就大不相同,期待声明。

Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and the Company’s other filings from time to time with the SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release.

这些因素包括本公司最近一份关于截至2022年12月31日财政年度表格10-K的年度报告中所述的因素,以及本公司与SEC不时提交的其他文件。预计投资者不得过度依赖这些前瞻性陈述,这些陈述仅在本新闻稿发布之日才发表。

The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise..

本公司不承担因新信息,未来事件或其他原因公开更新任何前瞻性声明的义务。。

Corporate Contact:

公司联系:

Reviva Pharmaceuticals Holdings, Inc.

Reviva Pharmaceuticals Holdings,Inc。

Laxminarayan Bhat, PhD

Laxminarayan Bhat博士

www.revivapharma.com

www.revivapharma.com

Investor Relations Contact:

投资者关系联系人:

LifeSci Advisors, LLC

LifeSci Advisors,LLC

Bruce Mackle

Bruce Mackle

bmackle@lifesciadvisors.com

bmackle@lifesciadvisors.com