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NurExone Reports First Quarter 2024 Financial Results and Provides Corporate Update, Moving Forward With FDA Guidelines for the Human Trials

NurExone Reports First Quarter 2024 Financial Results and Provides Corporate Update, Moving Forward With FDA Guidelines for the Human Trials

NurexOne公佈2024年第一季度財務業績並提供公司最新情況,推進FDA人體試驗指導方針
GlobeNewswire ·  05/29 20:35

TORONTO and HAIFA, Israel, May 29, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) (the "Company" or "NurExone"), a pioneering biopharmaceutical company developing regenerative medicine therapies, is pleased to announce its financial and operational results for the three months ended March 31, 2024, the highlights of which are included in this news release. The Company's full set of consolidated financial statements for the three months ended March 31, 2024, and accompanying management's discussion and analysis can be accessed by visiting the Company's website at and its profile page on SEDAR+ at .

多倫多和以色列海法,2024年5月29日(GLOBE NEWSWIRE)——開發再生藥物療法的開創性生物製藥公司NurexOne Biologic Inc.(TSXV:NRX)(OTCQB:NRXBF)(德國:J90)(“公司” 或 “Nurexone”)欣然宣佈其截至2024年3月31日的三個月的財務和經營業績,其中的亮點已包含在本新聞稿中。公司截至2024年3月31日的三個月的全套合併財務報表以及隨附的管理層討論和分析可訪問公司的網站及其在SEDAR+上的簡介頁面,網址爲。

Key Business Highlights

主要業務亮點

On March 1, 2024, the Company commenced the setup of in-house laboratories and offices to bolster its research and development capabilities, subsequent to entering into lease and construction agreements. Completion of these initiatives is anticipated by the end of June 2024.

在簽訂租賃和施工協議後,公司於2024年3月1日開始設立內部實驗室和辦公室,以增強其研發能力。這些舉措預計將於2024年6月底完成。

On March 22, 2024, the Company completed the acceleration of 12,682,340 warrants issued pursuant to a private placement of units that closed on June 15, 2022. Following the acceleration event, the Company received gross proceeds of US$2.92 million (approximately C$4.0 million) from the exercise of 10,423,629 common share purchase warrants, which represented accelerated and non-accelerated warrants of which 9,684,993 warrants were exercised at a price of C$0.38, 556,818 warrants were exercised at a price of C$0.34, and 181,818 warrants were exercised at a price of C$0.48. The Company exercised its right to accelerate the expiry date of certain warrants to thirty days upon the Company's common shares exceeded C$0.475 for ten consecutive trading days on the TSX Venture Exchange ("TSXV"). "We appreciate the confidence of the investors who exercise their warrants, and the ongoing support of NurExone's journey," stated Eran Ovadya, NurExone Chief Financial Officer.

2024年3月22日,公司完成了根據2022年6月15日結束的單位私募發行的12,682,340份認股權證的加速發行。加速事件發生後,公司通過行使10,423,629份普通股購買權證獲得了292萬美元(約合400萬加元)的總收益,其中包括加速和非加速認股權證,其中9,684,993份認股權證以0.38加元的價格行使,556,818份認股權證以0.34加元的價格行使,181,818份認股權證以0.34加元的價格行使 48。在公司在多倫多證券交易所風險交易所(“TSXV”)的普通股連續十個交易日超過0.475加元后,公司行使了將某些認股權證的到期日加快至三十天的權利。NureXone首席財務官埃蘭·奧瓦迪亞表示:“我們感謝行使認股權證的投資者的信心以及對NureXone發展歷程的持續支持。”

On April 1, 2024, the Company entered into a Contract Research Organization services agreement with Vivox Ltd. for animal experiments as part of the preclinical testing phase for the submission of an Investigational New Drug ("IND") application to the United States Food and Drug Administration (the "FDA"). This is aimed at assessing the safety and efficacy of the ExoPTEN drug before proceeding to clinical trials involving human subjects, which are anticipated to commence in 2025. This engagement followed the completion of a Pre-IND meeting with the FDA regarding the manufacturing, preclinical, and clinical development plan of ExoPTEN, NurExone's inaugural ExoTherapy product, and the subsequent receipt of a written response from the FDA.

2024年4月1日,公司與Vivox Ltd.簽訂了動物實驗合同研究組織服務協議,這是向美國食品藥品監督管理局(“FDA”)提交研究新藥(“IND”)申請的臨床前測試階段的一部分。這旨在評估ExOpten藥物的安全性和有效性,然後再進行涉及人體受試者的臨床試驗,這些試驗預計將於2025年開始。此次合作是在完成了與美國食品藥品管理局關於NurexOne首款Exotherapy產品Exopten的製造、臨床前和臨床開發計劃的IND前會議以及隨後收到美國食品藥品管理局的書面答覆之後進行的。

On April 25, 2024, NurExone successfully secured approval for listing on the OTCQB Venture Market, marking a significant milestone in the Company's growth and visibility within the financial community, including in the USA. In addition, the Company achieved Depository Trust Company eligibility, which enhances the efficiency and cost-effectiveness of trading NurExone shares, facilitating better liquidity and broader access for investors.

2024年4月25日,NurexOne成功獲得在OTCQB風險投資市場上市的批准,這標誌着公司在包括美國在內的金融界的增長和知名度方面的一個重要里程碑。此外,公司獲得了存託信託公司資格,這提高了交易NurexOne股票的效率和成本效益,爲投資者提供了更好的流動性和更廣泛的准入。

Growth Outlook for 2024

2024年的增長展望

According to Chief Executive Officer Dr. Lior Shaltiel, "NurExone is committed to pioneering transformations in the field of regenerative medicine with new, minimally invasive therapies and we are moving along the regulatory path towards human trials for our first product, ExoPTEN. Our focus remains on enhancing our ExoTherapy platform for the production of nanodrugs, expanding our intellectual property, and forging strategic collaborations. Towards this end, we have recently engaged Dr. Ram Petter, Vice President and head of Bio Strategy at Teva Pharmaceutical, to support our efforts in collaborating with biopharma companies."

首席執行官利爾·沙爾蒂爾博士表示:“NurexOne致力於通過新的微創療法在再生醫學領域開創性變革,我們正在監管道路上進行首款產品ExOpten的人體試驗。我們的重點仍然是增強用於生產納米藥物的Exotherapy平台,擴大我們的知識產權和建立戰略合作。爲此,我們最近聘請了梯瓦製藥副總裁兼生物戰略主管拉姆·佩特博士,以支持我們與生物製藥公司合作的努力。”

First Quarter Fiscal 2024 Financial Results

2024財年第一季度財務業績

  • Research and development expenses were US$0.22 million in the first quarter of 2024, compared to US$0.37 million in the same quarter in 2023. The decrease was primarily due to the receipt of a governmental grant of US$0.02 and reductions in stock-based compensation of US$0.08, subcontractor and materials expenses of US$0.05.
  • General and administrative expenses were US$0.70 million in the first quarter of 2024, compared to US$0.35 million in the same period in 2023. The increase was primarily due to costs related to public and investor relations services.
  • Finance expenses were US$0.01 million in the first quarter of 2024, compared to finance income of US$0.01 million in the same period in 2023, driven by income from bank interest.
  • Net loss was US$0.92 million in the first quarter of 2024, compared to a net loss of US$0.70 million in the first quarter of 2023.
  • 2024年第一季度的研發費用爲22萬美元,而2023年同期爲37萬美元。下降的主要原因是收到了0.02美元的政府補助金,股票補償減少了0.08美元,分包商和材料費用減少了0.05美元。
  • 2024年第一季度的一般和管理費用爲70萬美元,而2023年同期爲35萬美元。增長主要是由於與公共和投資者關係服務相關的成本。
  • 受銀行利息收入的推動,2024年第一季度的財務支出爲01萬美元,而2023年同期的財務收入爲01萬美元。
  • 2024年第一季度的淨虧損爲92萬美元,而2023年第一季度的淨虧損爲70萬美元。

As of March 31, 2024, the Company had cash and cash equivalents of US$3.25 million (December 31, 2023 - US$0.54 million) and working capital of US$3.31 million (December 31, 2023 - US$0.07 million). The increase in cash was primarily due to the completion of a private placement in January 2024 for gross proceeds of approximately US$1.49 million and the exercise of warrants in March 2024 for gross proceeds of approximately US$2.92 million.

截至2024年3月31日,該公司的現金及現金等價物爲325萬美元(2023年12月31日爲54萬美元),營運資金爲331萬美元(2023年12月31日爲07萬美元)。現金的增加主要是由於私募於2024年1月完成,總收益約爲149萬美元,以及於2024年3月行使認股權證,總收益約爲292萬美元。

The Company had an accumulated deficit of US$14.98 million as of March 31, 2024, (December 31, 2023 - US$14.06 million).

截至2024年3月31日,該公司的累計赤字爲1,498萬美元(2023年12月31日爲1,406萬美元)。

Eran Ovadya, NurExone's Chief Financial Officer, added: "The Company maintains a strong cash position, ensuring sufficient funding until year-end. With strategic oversight, we navigate our business plan amidst ongoing activities, positioning ourselves for sustained growth and continued success."

NureXone首席財務官埃蘭·奧瓦迪亞補充說:“公司保持強勁的現金狀況,確保在年底之前有足夠的資金。通過戰略監督,我們在持續的活動中制定業務計劃,爲持續增長和持續成功做好準備。”

About NurExone Biologic Inc.

關於 Nurexone Biologic Inc.

NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The Company's first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation by the FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.

NurexOne Biologic Inc. 是一家在多倫多證券交易所上市的製藥公司,正在開發一個平台,用於以非侵入性方式向中樞神經系統損傷的患者提供基於生物制導的外泌體療法。事實證明,該公司的第一款治療急性脊髓損傷的產品exOpten在鼻內給藥後可恢復75%的實驗室大鼠的運動功能。ExOpten已被美國食品藥品管理局授予孤兒藥稱號。NurexOne平台技術有望爲其他適應症的非侵入性靶向藥物遞送感興趣的製藥公司提供新的解決方案。

For additional information, please visit or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

欲了解更多信息,請在領英、推特、臉書或YouTube上訪問或關注NurexONE。

For more information, please contact:

欲了解更多信息,請聯繫:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Lior Shaltiel 博士
首席執行官兼董事
電話:+972-52-4803034
電子郵件:info@nurexone.com

Thesis Capital Inc.
Investment Relation - Canada
Phone: +1 905-347-5569
Email: IR@nurexone.com

論文資本公司
投資關係-加拿大
電話:+1 905-347-5569
電子郵件:IR@nurexone.com

Dr. Eva Reuter
Investment Relation - Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

伊娃·路透博士
投資關係-德國
電話:+49-69-1532-5857
電子郵件:e.reuter@dr-reuter.eu

FORWARD-LOOKING STATEMENTS

前瞻性陳述

This press release contains certain "forward-looking statements", that reflect the Company's current expectations and projections about its future results. Wherever possible, words such as "may", "will", "should", "could", "expect", "plan", "intend", "anticipate", "believe", "estimate", "predict" or "potential" or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to in-house laboratories and offices being completed on the timelines setout herein; the in-house laboratories and offices, once construction is completed, having the intended effect on the Company and its business; the Company's preclinical and clinical testing yielding their intended results; the Company proceeding to clinical trials on the timelines setout herein; the Company pioneering transformations in the field of regenerative medicine with new, minimally invasive therapies; the Company enhancing their ExoTherapy platform for production of nanodrugs, expanding their intellectual property, and forging strategic collaborations; the Company collaborating with biopharma companies; the Company having sufficient funding for its operations; the Company having sustained growth and continued success; and the NurExone platform technology offering novel solutions to drug companies.

本新聞稿包含某些內容 前瞻性陳述,這反映了公司當前對其未來業績的預期和預測。儘可能使用諸如此類的詞語 可能, , 應該, 可以, 期望, 計劃, 打算, 預測, 相信, 估計, 預言 要麼 潛力 或者這些詞語的負面或其他變體,或類似的詞語或短語,已被用來識別這些前瞻性陳述。本新聞稿中的前瞻性陳述包括但不限於與以下內容相關的陳述 內部實驗室和辦公室將按此處規定的時間表完工;內部實驗室和辦公室在施工完成後,將對公司及其業務產生預期影響;公司的臨床前和臨床測試得出預期結果;公司按此處規定的時間表進行臨床試驗; 該公司 通過新的微創療法在再生醫學領域開創性變革; 該公司 提高的 他們的 用於生產納米藥物的 Exotherapy 平台,正在擴展 他們的 知識產權和建立戰略合作;公司與生物製藥公司合作;公司有足夠的運營資金;公司持續增長並持續取得成功; NurexONE 平台技術優惠ing 爲製藥公司提供新穎的解決方案.

These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including the general business and economic conditions of the industries and countries in which we operate; the general market conditions; the ability to secure additional funding; the engagement of Dr. Petter will have its intended outcome; in-house laboratories and offices will be completed on the timelines setout herein and having their intended effects on the Company and its business; the Company's preclinical and clinical testing will yield their intended results; the Company will proceed to clinical trials on the timelines setout herein; the Company will pioneer transformations in the field of regenerative medicine with new, minimally invasive therapies; the Company will enhance their ExoTherapy platform for production of nanodrugs, expand their intellectual property, and forge strategic collaborations; the Company will collaborate with biopharma companies; the Company will have sufficient funding for its operations; the Company will have sustained growth and continued success; the Company will have better liquidity and broader access for investors; the Company will enter into new partnerships and/or licensing agreement; and the NurExone platform technology will offer novel solutions to drug companies.

這些陳述反映了管理層當前的信念,並基於截至本文發佈之日管理層目前獲得的信息。在撰寫本新聞稿中的前瞻性陳述時,我們應用了幾項重大假設,包括我們經營所在行業和國家的總體商業和經濟狀況; 總體市場狀況; 獲得額外資金的能力;Petter 博士的訂婚 會有 其預期結果; 內部實驗室和辦公室將按此處規定的時間表完工,並對公司及其業務產生預期影響;公司的臨床前和臨床測試將得出預期結果;公司將按照此處規定的時間表進行臨床試驗;公司 藉助新的微創療法,開創了再生醫學領域的變革; 該公司 會增強 他們的 用於生產納米藥物的Exotherapy平台,擴展 他們的 知識產權和僞造e 戰略合作; 該公司 合作e 與生物製藥公司合作;本公司 會有 爲其運營提供充足的資金;公司 會有 持續增長和持續成功; 公司將有更好的流動性,爲投資者提供更廣泛的准入; 公司 將進入 簽訂新的合作伙伴關係和/或許可協議;以及 NurexONE 平台技術 將提供 爲製藥公司提供新穎的解決方案.

Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to the Company's early stage of development; lack of revenues to date; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; protection of the Company's intellectual property; dependence on the Company's strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; the Company being unable to complete construction of in-house laboratories and offices and/or these initiatives not having the intended effect on the Company and its business; the Company being unable to pioneer transformations in the field of regenerative medicine; the Company being unable to enhance their ExoTherapy platform for production of nanodrugs, expand their intellectual property and/or forging strategic collaborations; the Company being unable to collaborate with biopharma companies; the Company being unable to have sustained growth and/or continued success; the NurExone platform technology being unable to offer novel solutions to drug companies; and the risks discussed under the heading "Risk Factors" on pages 29 to 36 of the Company's Annual Information Form dated March 30, 2023, a copy of which is available under the Company's SEDAR+ profile at . These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

前瞻性陳述涉及重大風險、不確定性和假設。許多因素可能導致實際業績、業績或成就與前瞻性陳述中討論或暗示的結果存在重大差異。這些風險和不確定性包括但不限於與公司早期發展階段相關的風險; 迄今爲止收入不足; 政府監管; 其產品的市場接受度; 快速的技術變革; 對關鍵人員的依賴; 保護公司的知識產權; 對公司戰略合作伙伴的依賴; 臨床前藥物開發尚不確定,公司的候選藥物可能永遠無法進入臨床試驗;臨床前研究和早期臨床試驗的結果可能無法預測後期臨床試驗的結果;公司產品開發活動、臨床前研究和臨床試驗的結果、成本和時間的不確定性;不確定的臨床開發流程,包括臨床試驗可能沒有有效設計或產生的風險積極的結果;可能無法獲得或維持對公司候選藥物產品的監管批准;推出比公司候選藥物更安全、更有效、更便宜或更優於公司的候選藥物的競爭藥物;臨床前研究和臨床試驗的啓動、進行和完成可能會受到不可預見問題的不利影響或影響;可能無法獲得足夠的融資;可能無法獲得或維持該藥物的知識產權保護本公司的候選產品; 公司無法完成內部實驗室和辦公室的建設和/或這些舉措對公司及其業務沒有預期影響;公司 無法 先鋒 再生醫學領域的轉變;公司無法 增強e 他們的 用於生產納米藥物的 Exotherapy 平台s, 擴大 他們的 知識產權 和/或 建立戰略合作;公司無法與生物製藥公司合作;公司無法實現持續增長和/或持續成功; NurexONE 平台技術 無法提供 爲製藥公司提供新穎的解決方案; 以及標題下討論的風險 風險因素 在公司2023年3月30日的年度信息表的第29至36頁上,該表的副本可在公司的SEDAR+簡介下找到,網址爲 。應仔細考慮這些因素,讀者不應過分依賴前瞻性陳述。儘管本新聞稿中包含的前瞻性陳述基於管理層認爲的合理假設,但公司無法向讀者保證實際業績將是 與這些前瞻性陳述一致。這些前瞻性陳述自本新聞稿發佈之日起作出,除非法律要求,否則公司沒有義務更新或修改這些陳述以反映新的事件或情況。

Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

都不是 TSXV 也不是其監管服務提供商(該術語在政策中定義) TSXV) 對本新聞稿的充分性或準確性承擔責任。


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