Reviva Announces $3 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Reviva Announces $3 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
CUPERTINO, Calif., May 28, 2024 — 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 a definitive agreement for the sale and issuance of 1,898,734 shares of the Company's common stock and warrants to purchase up to 1,898,734 shares of common stock at a combined offering price of $1.58 per share of common stock and accompanying warrant in a registered direct offering priced at-the-market under the Nasdaq rules. The warrants have an exercise price of $1.455 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 May 29, 2024, subject to the satisfaction of customary closing conditions.
Reviva Pharmaceuticals Holdings, Inc.(NASDAQ: RVPH)(“Reviva”或“公司”)於2024年5月28日加利福尼亞州庫比蒂諾市宣佈,公司已與潛在投資者達成協議,以1.58美元的每股發行價和附帶認股權證的形式,在納斯達克規定市場下進行定向註冊直接發行,併發行1,898,734股普通股和認股權證,認股權證可購買多達1,898,734股普通股。認股權證的行權價格爲每股1.455美元,將立即行使,並在發行之日起五年後到期。該交易預計於2024年5月29日或前後完成,需要滿足一般常規交割條款。
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
H.C.Wainwright & Co.將擔任本次定向增發的獨家配售代理。
The gross proceeds to Reviva from this offering are expected to be approximately $3 million, 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 for working capital and other general corporate purposes.
本次發行預計爲Reviva融資約300萬美元,未扣除承銷代理的費用和其他發行費用。Reviva公司計劃利用本次發行的淨收益加上現有的現金和現金等價物,用於研發活動,包括註冊第三階段RECOVER-2試驗,並用於營運資金和其他一般公司用途。
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. 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.
上述證券是根據333-262348號文件向證券交易委員會(“SEC”)提供的“架子”註冊聲明進行發行的,該註冊聲明於2022年1月26日提交,並於2022年2月2日獲得生效。證券的發行僅通過部分有效註冊聲明組成的招股說明書進行。與發行相關的招股說明書和附帶的招股書將提交給SEC。當可獲得時,招股說明書和附帶的招股書的電子副本可以在SEC的網站www.sec.gov上獲取,或通過H.C. Wainwright&Co. LLC獲得,地址爲430 Park Avenue,3rd Floor,New York,NY 10022,電話爲212-856-5711,或者通過電子郵件與該公司聯繫。該研究中的LIBERTY Endovascular Robotic Surgical System旨在通過消除大型、笨重和昂貴的資本設備,同時減少輻射暴露和醫生的負擔,改進目前在內臟手術機器人中使用機器人技術的方法。公司相信,LIBERTY Endovascular Robotic Surgical System的遠程操作具有成爲民主化內臟介入手術程序的第一個系統的潛力。.
The Company also has agreed that certain existing warrants held by the investor in the offering to purchase up to an aggregate of 1,365,854 shares of the Company's common stock that were previously issued to the investor in November 2023, with an exercise price of $5.00 per share, will be amended for $0.125 per amended warrant, effective upon the closing of the offering, so that the amended warrants will have a reduced exercise price of $1.455 per share and will expire five years following the closing of the offering.
此外,公司還同意將投資者持有的某些現有認股權證,可購買公司的1,365,854股普通股,在2013年11月發給該投資者時進行了修訂,行權價格爲每股5.00美元。修訂後的每一份認股權證每份將以0.125美元的價格修訂,將於交易結束時生效。修訂後的認股權證行權價格降至每股1.455美元,行權期限爲發行結束後五年。
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.
此新聞稿不作爲銷售或購買該證券的要約或邀請,也不得在任何未經該州或司法管轄區證券法規定下的州或司法管轄區進行該證券的銷售。
About Brilaroxazine
關於Brilaroxazine
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. 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. 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).
Brilaroxazine是一種新的化學實體,具有與精神分裂症及其伴發症相關的關鍵血清素和多巴胺受體的有效結合和選擇性。來自全球範圍內的精神分裂症第三階段RECOVER試驗的陽性拓撲數據證明,該試驗以50毫克Brilaroxazine與安慰劑比較,所有主要症狀領域在第4周統計上均有顯著和臨床意義的減少,不良反應與安慰劑相當,退藥率低於安慰劑。一項旨在研究CYP3A4酶對健康受試者中Brilaroxazine的潛在影響的臨床藥物相互作用(DDI)研究的陽性數據支持當與CYP3A4抑制劑結合時,無臨床意義的相互作用。Reviva認爲,Brilaroxazine已完成了符合監管規定的毒理學和安全藥理學研究。Reviva打算開發Brilaroxazine,用於治療其他神經精神疾病,包括雙相情感障礙,重度抑鬱障礙(MDD)和注意缺陷多動障礙(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. FDA for the treatment of PAH and IPF conditions.
此外,Brilaroxazine在炎性疾病牛皮癬、肺動脈高壓(PAH)和特發性肺纖維化(IPF)的非臨床活性中表現出有希望的結果,可以在動物的轉化模型中減輕纖維化和炎症。Brilaroxazine已獲得美國FDA授予治療PAH和IPF疾病的孤兒藥品認定。
To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.
有關Brilaroxazine可用的臨床和臨床前數據,詳見revivapharma.com/publications關於Reviva.
About Reviva
Reviva是一家後期生物製藥公司,致力於爲代表醫學需求和對社會、患者及其家人造成負擔的疾病開發、發現和尋求商業化的下一代治療方案。 Reviva目前的產品管道集中於中樞神經、呼吸和代謝類疾病。Reviva的產品管道目前包括兩種藥物候選,即Brilaroxazine(RP5063)和RP1208。兩者均是公司內部自行發現的新型化學實體。 Reviva已在美國,歐洲和其他幾個國家獲得了Brilaroxazine和RP1208的組成專利權。
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'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.
此新聞稿包含某些前瞻性陳述,這些陳述涉及本次發行、發行的交割條件是否滿足、發行的完成、本次發行的募集資金金額和預期使用途徑、公司預期關於其產品候選的臨床特性、包括預期的療效或安全性方面的陳述以及公司關於事項的預期、意圖或信念,包括產品開發、臨床和監管時間表和費用、市場機會、籌集足夠資金的能力、競爭地位、潛在的或假定的未來運營結果、商業策略、潛在的增長機會和其他具有預測性的自然語言。這些前瞻性陳述基於我們所處的行業和市場的當前期望、估計、預測和投射,以及管理層的當前信仰和假設。
Forward-Looking Statements
前瞻性聲明
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. 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.
這些陳述可能基於前瞻性表達,包括但不限於“期望”、“預計”、“打算”、“計劃”、“相信”、“估計”、“潛力”、“預測”、“項目”、“應該”、“願意”及類似表述和那些術語的否定形式。這些陳述涉及未來事件或我們的財務表現,並涉及已知和未知風險、不確定性和其他因素,這些因素可能導致實際結果、表現或業績與前瞻性陳述中的任何未來結果、表現或業績實際結果實現是否明確的風險、不確定性和其他因素產生實質性不同。此類因素包括該公司最近的《2019年10-K業績》,以及公司不時提交給SEC的其他其他文件中所述。提示性投資者應謹慎不要過度依賴這些前瞻性陳述,這些前瞻性陳述僅作爲本新聞稿的日期。該公司無需公開更新任何前瞻性聲明,無論是因爲新信息、未來事件還是其他原因產生的。
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. 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, 2023, 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. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
公司聯繫方式: Laxminarayan Bhat, PhD,www.revivapharma.com,Kristin Politi,kpoliti@lifescicomms.com,(646) 876-4783
Corporate Contact:
公司聯繫方式:
Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD
www.revivapharma.com
Reviva Pharmaceuticals Holdings,Inc.
Laxminarayan Bhat, PhD
www.revivapharma.com
Investor Relations Contact:
LifeSci Advisors, LLC
Bruce Mackle
bmackle@lifesciadvisors.com
投資者關係聯繫方式:
LifeSci Advisors,LLC
Bruce Mackle
bmackle@lifesciadvisors.com
Media Contact:
Kristin Politi
kpoliti@lifescicomms.com
(646) 876-4783
媒體聯繫人:
Kristin Politi
kpoliti@lifescicomms.com
(646) 876-4783