Los Gatos, Calif., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (OTC: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced the pricing of an offering of 10,000,000 shares of the Company's common stock (or pre-funded warrants in lieu thereof) and accompanying warrants to purchase up to 10,000,000 shares of common stock at a combined offering price of $0.20 per share of common stock (or pre-funded warrant) and accompanying warrant. Each warrant will have an exercise price per share of $0.20, will be exercisable immediately and will terminate on the five year anniversary of the date of issuance. The closing of the offering is expected to occur on or about August 4, 2023, subject to the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
The gross proceeds to the Company from the offering are expected to be $2 million, before deducting the placement agent's fees and other offering expenses payable by the Company. Aridis Pharmaceuticals currently intends to use the net proceeds from the offering for working capital and general corporate purposes.
The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-272128) originally filed with the Securities and Exchange Commission ("SEC") on May 22, 2023 and declared effective on August 1, 2023. The offering is being made only by means of a prospectus, which is part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC's website at http://www.sec.gov and may also be obtained 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.
The Company also has agreed that certain existing warrants to purchase up to an aggregate of (i) 2,473,778 shares of the Company's common stock that were previously issued in August 2021, as amended, at an exercise price of $2.00 per share and (ii) 7,207,208 shares of the Company's common stock that were previously issued in October 2022, at an exercise price of $1.11 per share, will be amended effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $0.20 per share and a termination date on the five year anniversary of the closing date of the offering.
This press release shall not constitute an offer to sell or a 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 the registration or qualification under the securities laws of any such state or jurisdiction.
About Aridis Pharmaceuticals, Inc.
Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as first-line treatments to combat antimicrobial resistance (AMR) and viral pandemics. The Company is utilizing its proprietary ʎPEX and MabIgX technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture mAbs for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized by the natural human immune system for high potency. Hence, they are already fit-for-purpose anddo not require further engineering optimization to achieve full functionality.
The Company has generated multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antibacterial and antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care, which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company's pipeline is highlighted below:
Aridis' Pipeline
AR-301 (VAP/HAP/CAP). AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive S. aureus alpha-toxin in ventilator associated pneumonia (VAP), ventilated hospital acquired pneumonia (HAP), and ventilated community acquired pneumonia (CAP) patients.
AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients. This program is currently in a Phase 2a clinical study in CF patients.
AR-320 (VAP). AR-320 is a fully human mAb targeting S. aureus alpha-toxin for prevention of VAP. Statistically significant Phase 2 data in the target population of those ≤ 65 years of age was published in the September 2021 Lancet Infectious Diseases journal. The Company has completed discussions with the EMA and FDA on study design and recently launched the Phase 3 study.
AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that target multiple sites on the spike proteins of the SARS-CoV-2 virus.
AR-101 (HAP). AR-101 is a fully human IgM mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa HAP cases worldwide. This program is licensed to the Serum Institute of India and Shenzhen Arimab.
AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb directed against the F-protein of diverse clinical isolates of respiratory syncytial virus (RSV). This program is licensed exclusively to the Serum Institute of India.
AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.
加利福尼亞州洛斯加託斯,2023年8月2日(GLOBE NEWSWIRE)——專注於發現和開發用於治療危及生命的感染的新型抗感染療法的生物製藥公司Aridis Pharmicals, Inc.(場外交易代碼:ARDS)今天宣佈了發行1,000萬股公司普通股(或代替預先融資的認股權證)和隨附的認股權證的定價 00萬股普通股,合併發行價爲每股普通股(或預先注資的認股權證)和隨附的認股權證。每份認股權證的行使價爲每股0.20美元,可立即行使,並將在發行之日五週年之日終止。本次發行預計將於2023年8月4日左右結束,但須滿足慣例成交條件。
H.C. Wainwright & Co. 擔任本次發行的獨家配售代理。
在扣除配售代理費用和公司應支付的其他發行費用之前,預計本次發行給公司的總收益爲200萬美元。Aridis Pharmicals目前打算將此次發行的淨收益用於營運資金和一般公司用途。
上述證券是根據S-1表格(文件編號333-272128)上的註冊聲明發行的,該聲明最初於2023年5月22日向美國證券交易委員會(“SEC”)提交,並於2023年8月1日宣佈生效。本次發行僅通過招股說明書進行,招股說明書是有效註冊聲明的一部分。與本次發行有關的初步招股說明書已提交給美國證券交易委員會。最終招股說明書的電子副本(如果有)可在美國證券交易委員會的網站上獲得 http://www.sec.gov 也可以通過致電 (212) 856-5711 或發送電子郵件至 10022 聯繫位於紐約州紐約公園大道 430 號的 H.C. Wainwright & Co., LLC 獲得 placements@hcwco.com。
公司還同意,某些現有認股權證,以每股2.00美元的行使價購買總額不超過 (i) 2021年8月發行的經修訂的公司普通股的2473,778股,以及 (ii) 先前於2022年10月發行、行使價爲每股1.11美元的7,207,208股公司普通股的認股權證,將在發行結束後進行修訂,因此,修訂後的認股權證的行使價將降至每股0.20美元,終止日期爲五年發行截止日期的週年紀念日。
本新聞稿不構成出售要約或招攬購買這些證券的要約,也不得在任何州或司法管轄區根據任何此類州或司法管轄區的證券法進行註冊或獲得資格之前,在任何州或司法管轄區出售這些證券,如果此類要約、招標或出售是非法的。
關於 Aridis 製藥有限公司
Aridis Pharmicals, Inc. 發現並開發了抗感染藥物,可用作對抗抗微生物藥物耐藥性(AMR)和病毒流行的一線治療方法。該公司正在利用其專有的 pex 和 mabiGX 技術平台,從成功克服感染的患者身上快速鑑定出稀有、強效抗體產生抗體的B細胞,並快速製造用於治療危重感染的單克隆抗體。這些單克隆抗體已經來自人類,並經過人類天然免疫系統的功能優化,具有很高的效力。因此,它們已經適合用途,不需要進一步的工程優化即可實現全部功能。
除了臨床前階段的抗菌和抗病毒單抗外,該公司還生產了多個針對導致生命危險感染的細菌的臨床階段單抗體,例如呼吸機相關性肺炎(VAP)和醫院獲得性肺炎(HAP)。使用單克隆抗體作爲抗感染治療代表了一種利用人體免疫系統對抗感染的創新治療方法,旨在克服與當前護理標準(即廣譜抗生素)相關的缺陷。此類缺陷包括但不限於耐藥性增加、療效持續時間短、人類微生物組正常菌羣的破壞以及當前治療方法之間缺乏差異。mAb產品組合輔之以一種非抗生素的新機制小分子抗感染候選藥物,用於治療囊性纖維化患者的肺部感染。該公司的渠道如下所示:
Aridis Pharmaceuticals 的管道
AR-301 (VAP/HAP/CAP)。AR-301 是一種全人類 IgG1 單克隆抗體,目前正處於 3 期臨床開發階段,靶向革蘭氏陽性 金黃色葡萄球菌 呼吸機相關性肺炎 (VAP)、通風醫院獲得性肺炎 (HAP) 和通氣社區獲得性肺炎 (CAP) 患者中的α-毒素。
AR-501 (囊性纖維化)。AR-501 是一種具有廣譜抗感染活性的檸檬酸鎵吸入製劑,用於治療囊性纖維化患者的慢性肺部感染。該項目目前正處於針對 CF 患者的2a期臨床研究中。
AR-320 (VAP)。AR-320 是一種全人類 mAB 靶向 金黃色葡萄球菌 用於預防 VAP 的 α-毒素。2021 年 9 月《柳葉刀傳染病》雜誌上發佈了目標人羣中 65 歲以下人羣的第 2 階段數據,具有統計學意義。該公司已經完成了與EMA和FDA關於研究設計的討論,最近啓動了第三階段研究。
AR-701 (新冠肺炎)。AR-701 是一種從康復期的 COVID-19 患者身上發現的全人類 mAB 混合物,靶向 SARS-CoV-2 病毒刺突蛋白的多個位點。
AR-101 (哈普)。AR-101 是一種全人類 IgM 單抗體,正處於 2 期臨床開發階段 銅綠假單胞菌 脂糖血清型 O11,約佔所有脂糖的 22% 銅綠假單胞菌 全球範圍內的 HAP 病例。該項目已獲得印度血清研究所和深圳Arimab的許可。
AR-201 (呼吸道合胞病毒感染)。AR-201 是一種針對呼吸道合胞病毒 (RSV) 多種臨床分離株的 F 蛋白的全人類 IgG1 單抗。該程序由印度血清研究所獨家授權。
AR-401 (血液感染)。AR-401 是一項全人類 mAB 臨床前項目,旨在治療革蘭氏陰性引起的感染 鮑曼不動桿菌。