Quoin Pharmaceuticals Provides Corporate Update and Announces Fourth Quarter and 2023 Financial Results
Quoin Pharmaceuticals Provides Corporate Update and Announces Fourth Quarter and 2023 Financial Results
Company reported positive initial clinical data for QRX003 from first six evaluable subjects in ongoing open-label Netherton Syndrome study with positive benefits observed across a number of clinical endpoints
在正在進行的開放標籤內瑟頓綜合徵研究中，公司報告了前六名可評估受試者的 QRX003 初步臨床數據爲陽性，在多個臨床終點中觀察到積極的益處
Eligibility age for enrollment into both studies has been lowered to fourteen years and older
兩項研究的入學資格年齡已降至十四歲及以上
No safety concerns have been observed to date in either ongoing clinical study
迄今爲止，在兩項正在進行的臨床研究中均未發現任何安全問題
Quoin expects its cash runway will extend into the second half of 2025 following $6.5 million offering on March 5th
Quoin預計，繼3月5日發行650萬美元之後，其現金流將延續到2025年下半年第四
Cash Runway to be further extended by $8 million Equity Line of Credit arrangement signed January 25, 2024
2024年1月25日簽署的800萬美元股權信貸額度安排將進一步延長 Cash Runway
ASHBURN, Va., March 13, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today provides a business update and announces financial results for the quarter and year ended December 31, 2023.
弗吉尼亞州阿什本，2024年3月13日（環球新聞專線）——專注於罕見病和孤兒病的臨床階段專業製藥公司Quoin Pharmicals Ltd.（納斯達克股票代碼：QNRX）（“公司” 或 “Quoin”）今天提供了最新業務並公佈了截至2023年12月31日的季度和年度的財務業績。
Quoin CEO, Dr. Michael Myers, said, "2023 marked another year of significant progress for Quoin and for the development of QRX003 for the treatment of Netherton Syndrome. Notably, we released initial positive data from our open label clinical study, representing a first for the very underserved Netherton community. That progress has continued, and based on the strength of the initial positive clinical data, we implemented a number of important protocol changes that we believe could lead to a more streamlined development program overall.
Quoin 首席執行官邁克爾·邁爾斯博士表示：“2023 年標誌着 Quoin 和用於治療內瑟頓綜合症的 QRX003 的開發又取得重大進展的一年。值得注意的是，我們發佈了開放標籤臨床研究的初步陽性數據，這對於服務嚴重不足的Netherton社區來說是第一次。這種進展仍在繼續，基於初步的陽性臨床數據，我們實施了許多重要的方案變更，我們認爲這些變更可能會使總體開發計劃更加簡化。
"We have also strengthened our balance sheet through the recently completed $6.5 million capital raise and we have the capacity to further solidify our cash position via the $8.0 million equity line of credit transaction we entered into earlier this year, once shareholder approval is received. We continue to believe that Quoin is in position to deliver the first approved treatment for this terrible disease."
“我們還通過最近完成的650萬澳元融資，加強了資產負債表，一旦獲得股東批准，我們有能力通過今年早些時候達成的800萬美元股權信貸額度交易進一步鞏固我們的現金狀況。我們仍然相信，Quoin有能力爲這種可怕的疾病提供第一種獲得批准的治療方法。”
Recent Corporate Highlights –
近期企業亮點 —
- On March 4th, Quoin announced FDA Clearance to recruit teen subjects into both ongoing Netherton Syndrome clinical studies.
- On February 8th, 2024, Quoin filed U.S. and International patent applications for a novel Netherton Syndrome combination product.
- On December 13th, Quoin announced FDA clearance of the Clinical Optimization Plan for QRX003 for Netherton Syndrome
- On October 24th, Quoin announced positive clinical data from the first six evaluable patients in the company's open-label clinical trial in Netherton Syndrome patients.
- Five of the six subjects reported that their pruritus, or itch, was either negligible or absent following treatment with QRX003, a significant improvement from prior to the study.
- All six subjects exhibited improvement in the Investigator assessed skin scoring system with three subjects showing improvement at the completion of the study and the other three at various points during the study.
- All six subjects expressed a favorable impression of QRX003 across multiple assessed metrics.
- No safety concerns have been reported to date for any subject in either of Quoin's studies.
- 3 月 4 日第四，Quoin宣佈美國食品藥品管理局批准招募青少年受試者參加兩項正在進行的內瑟頓綜合症臨床研究。
- 2 月 8 日第四，2024年，Quoin爲一種新的內瑟頓綜合症組合產品提交了美國和國際專利申請。
- 在 12 月 13 日第四，Quoin 宣佈美國食品藥品管理局批准了內瑟頓綜合症 QRX003 的臨床優化計劃
- 10 月 24 日第四，Quoin宣佈了該公司針對內瑟頓綜合症患者的開放標籤臨床試驗中前六名可評估患者的積極臨床數據。
- 六名受試者中有五名報告說，在使用 QRX003 治療後，他們的瘙癢或瘙癢可以忽略不計或消失，與研究前相比有了顯著改善。
- 所有六名受試者在研究人員評估的皮膚評分系統中均表現出改善，其中三名受試者在研究完成時表現出改善，另外三名受試者在研究期間的不同時刻表現出改善。
- 在多項評估指標中，所有六名受試者都對 QRX003 表示了良好的印象。
- 迄今爲止，在Quoin的兩項研究中，均未報告任何受試者的安全問題。
Financial Highlights
財務要聞
- Quoin had approximately $10.7 million in cash, cash equivalents and marketable securities as of December 31, 2023. This does not include the proceeds from the $6.5 million public offering of common shares that the company announced on March 5, 2024, nor the anticipated proceeds from the $8 million equity line of credit transaction which was entered into in January of this year. Implementation of this remains subject to shareholder approval.
- Net loss for the quarter ended December 31, 2023 was approximately $2.0 million compared to approximately $2.0 million for the quarter ended December 31, 2022. Net loss for the twelve months ended December 31, 2023 was $8.7 million compared to $9.4 million for the twelve months ended December 31, 2022.
- Investors are encouraged to read the Company's Annual Report on Form 10-K when it is filed with the Securities and Exchange Commission (the "SEC"), which will contain additional details about Quoin's financial results as of and for the period ended December 31, 2023.
- 截至2023年12月31日，Quoin擁有約1,070萬美元的現金、現金等價物和有價證券。這不包括該公司於2024年3月5日宣佈的650萬美元普通股公開發行所得的收益，也不包括今年1月達成的800萬美元股權信貸額度交易的預期收益。這項措施的實施仍需獲得股東的批准。
- 截至2023年12月31日的季度淨虧損約爲200萬美元，而截至2022年12月31日的季度淨虧損約爲200萬美元。截至2023年12月31日的十二個月淨虧損爲870萬美元，而截至2022年12月31日的十二個月淨虧損爲940萬美元。
- 鼓勵投資者閱讀公司向美國證券交易委員會（“SEC”）提交的10-K表年度報告，該報告將包含有關Quoin截至2023年12月31日的財務業績的更多細節。
Quoin will host a conference call and webcast at 8:30am ET on Thursday, March 14, 2024. The call will include a discussion of fourth quarter and full year 2023 financial results and a corporate update. The live call can be accessed by dialing 1-800-603-0527 (domestic) or 1-412-317-0688 (international). The live and archived webcast of the call will also be available on the Quoin Pharmaceuticals website under the Investors section or by following this link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=ZmehVyN5
Quoin將於美國東部時間2024年3月14日星期四上午8點30分主持電話會議和網絡直播。電話會議將包括對2023年第四季度和全年財務業績的討論以及公司最新情況。撥打1-800-603-0527（國內）或1-412-317-0688（國際）即可進行實時通話。電話會議的直播和存檔網絡直播也將在Quoin Pharmicals網站上的 “投資者” 欄目下或通過以下鏈接播出： https://event.choruscall.com/mediaframe/webcast.html?webcastid=ZmehVyN5
About Quoin Pharmaceuticals Ltd.
關於 Quoin 製藥有限公司
Quoin Pharmaceuticals Ltd. is a clinical stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin's innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.
Quoin Pharmicals Ltd. 是一家臨床階段的專業製藥公司，專注於開發和商業化治療罕見病和孤兒病的治療產品。我們致力於解決患者、他們的家人、社區和護理團隊未得到滿足的醫療需求。Quoin的創新產品線包括四種正在開發的產品，這些產品共同有可能靶向大量罕見和孤兒適應症，包括內瑟頓綜合徵、皮膚脫皮綜合徵、掌足角化病、硬皮病、大皰性表皮鬆解症等。欲了解更多信息，請訪問： www.quoinpharma.com 要麼 領英 用於更新。
Cautionary Note Regarding Forward Looking Statements
關於前瞻性陳述的警示說明
The Company cautions that statements in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. All statements that reflect the Company's expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to the Company's expected cash runway, the belief that certain protocol changes could lead to a more streamlined development program and the belief that the Company is in a position to deliver the first approved treatment for Netherton Syndrome. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 that the Company filed with the SEC. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
該公司警告說，本新聞稿中未描述歷史事實的陳述是1995年《私人證券訴訟改革法》所指的前瞻性陳述。前瞻性陳述可以通過使用提及未來事件或情況的詞語來識別，例如 “期望”、“打算”、“計劃”、“預測”、“相信” 和 “將” 等。除歷史事實陳述外，所有反映公司對未來的預期、假設、預測、信念或觀點的陳述均爲前瞻性陳述，包括但不限於與公司預期現金流有關的陳述、某些協議變更可能導致更簡化的開發計劃的信念以及認爲公司有能力提供第一種獲批准的內瑟頓綜合症療法。由於此類陳述受風險和不確定性的影響，因此實際結果可能與此類前瞻性陳述所表達或暗示的結果存在重大差異。這些前瞻性陳述基於公司當前的預期，涉及可能永遠無法實現或可能被證明不正確的假設。由於各種風險和不確定性，實際結果和事件發生時間可能與此類前瞻性陳述中的預期存在重大差異。有關影響公司的風險和不確定性的更多詳細信息包含在公司向美國證券交易委員會提交的截至2023年12月31日止年度的10-K表年度報告中 “風險因素” 標題下。不應過分依賴這些前瞻性陳述，這些陳述僅代表發表之日。除非法律要求，否則公司沒有義務更新此類聲明以反映在聲明發表之日後發生的事件或存在的情況。
For further information:
欲了解更多信息：
PCG Advisory
Stephanie Prince
sprince@pcgadvisory.com
(646) 863-6341
PCG 諮詢
斯蒂芬妮普林斯
sprince@pcgadvisory.com
(646) 863-6341
-Tables Follow-
-表格如下-
QUOIN PHARMACEUTICALS LTD.
QUOIN 製藥有限公司
Consolidated Balance Sheets
合併資產負債表
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,401,198 | $ | 2,860,628 | ||||
| Investments | 8,293,663 | 9,992,900 | ||||||
| Prepaid expenses and other current assets | 591,034 | 516,584 | ||||||
| Total current assets | 11,285,895 | 13,370,112 | ||||||
| Prepaid expenses - long term | 300,000 | 383,390 | ||||||
| Intangible assets, net | 583,334 | 704,561 | ||||||
| Total assets | $ | 12,169,229 | $ | 14,458,063 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 526,523 | $ | 605,600 | ||||
| Accrued expenses | 1,308,706 | 1,175,705 | ||||||
| Accrued interest and financing expense | 1,146,251 | 1,146,251 | ||||||
| Due to officers - short term | 600,000 | 600,000 | ||||||
| Total current liabilities | 3,581,480 | 3,527,556 | ||||||
| Due to officers - long term | 2,923,733 | 3,523,733 | ||||||
| Total liabilities | $ | 6,505,213 | $ | 7,051,289 | ||||
| Commitments and contingencies | ||||||||
| Shareholders' equity: | ||||||||
| Ordinary shares, no par value per share, 100,000,000 and 8,333,334 ordinary shares authorized at December 31, 2023 and 2022, respectively - 987,220 (987,220 ADS's) | $ | - | $ | - | ||||
| ordinary shares issued and outstanding at December 31, 2023 and 403,887 | ||||||||
| (403,887 ADS's) at December 31, 2022 | ||||||||
| Treasury stock, | - | (2,932,000) | ||||||
| -0- ordinary shares issued at December 31, 2023 and 45 ordinary shares issued at December 31, 2022 | ||||||||
| Additional paid in capital | 51,867,336 | 47,855,521 | ||||||
| Accumulated deficit | (46,203,320) | (37,516,747) | ||||||
| Total shareholders' equity | 5,664,016 | 7,406,774 | ||||||
| Total liabilities and shareholders' equity | $ | 12,169,229 | $ | 14,458,063 | ||||
| 十二月三十一日 | 十二月三十一日 | |||||||
| 2023 | 2022 | |||||||
| 資產 | ||||||||
| 流動資產： | ||||||||
| 現金和現金等價物 | $ | 2,401,198 | $ | 2,860,628 | ||||
| 投資 | 8,293,663 | 9,992,900 | ||||||
| 預付費用和其他流動資產 | 591,034 | 516,584 | ||||||
| 流動資產總額 | 11,285,895 | 13,370,112 | ||||||
| 預付費用-長期 | 300 | 383,390 | ||||||
| 無形資產，淨額 | 583,334 | 704,561 | ||||||
| 總資產 | $ | 12,169,229 | $ | 14,458,063 | ||||
| 負債和股東權益 | ||||||||
| 流動負債： | ||||||||
| 應付賬款 | $ | 526,523 | $ | 605,600 | ||||
| 應計費用 | 1,308,706 | 1,175,705 | ||||||
| 應計利息和融資費用 | 1,146,251 | 1,146,251 | ||||||
| 應歸於軍官——短期 | 60萬 | 60萬 | ||||||
| 流動負債總額 | 3,581,480 | 3,527,556 | ||||||
| 應歸於軍官——長期 | 2,923,733 | 3,523,733 | ||||||
| 負債總額 | $ | 6,505,213 | $ | 7,051,289 | ||||
| 承付款和意外開支 | ||||||||
| 股東權益： | ||||||||
| 普通股，每股無面值，截至2023年12月31日和2022年12月31日分別授權的1億股和8,333,334股普通股——987,220（987,220 ADS） | $ | - | $ | - | ||||
| 截至2023年12月31日已發行和流通的普通股和403,887股 | ||||||||
| 截至2022年12月31日（403,887 ADS） | ||||||||
| 庫存股， | - | (2,932,000) | ||||||
| -0-2023年12月31日發行的普通股和2022年12月31日發行的45股普通股 | ||||||||
| 額外實收資本 | 51,867,336 | 47,855,521 | ||||||
| 累計赤字 | (46,203,320) | (37,516,747) | ||||||
| 股東權益總額 | 5,664,016 | 7,406,774 | ||||||
| 負債和股東權益總額 | $ | 12,169,229 | $ | 14,458,063 | ||||
QUOIN PHARMACEUTICALS LTD.
QUOIN 製藥有限公司
Consolidated Statements of Operations
合併運營報表
| Years Ended December 31, | Three months ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| (Audited) | (Audited) | (Unaudited) | (Unaudited) | ||||||||||||
| Operating expenses | |||||||||||||||
| General and administrative | $ | 6,070,517 | $ | 6,584,868 | $ | 1,385,276 | $ | 1,472,866 | |||||||
| Research and development | 3,307,987 | 2,672,836 | 832,391 | 613,067 | |||||||||||
| Total operating expenses | 9,378,504 | 9,257,704 | 2,217,667 | 2,085,933 | |||||||||||
| Other (income) and expenses | |||||||||||||||
| Forgiveness of accounts payable | - | (416,000) | - | - | |||||||||||
| Warrant liability (income) expense | - | (77,237) | - | - | |||||||||||
| Unrealized loss (gain) | 2,683 | (1,307) | (9,243) | (4,360) | |||||||||||
| Realized and accrued interest income | (694,614) | (95,745) | (158,546) | (80,613) | |||||||||||
| Interest and financing expense | - | 714,081 | - | - | |||||||||||
| Total other (income) expense | (691,931) | 123,792 | (167,789) | (84,973) | |||||||||||
| Net loss | $ | (8,686,573) | $ | (9,381,496) | $ | (2,049,878) | $ | (2,000,960) | |||||||
| Deemed dividend on warrant modification | - | (65,266) | - | - | |||||||||||
| Net loss attributable to shareholders | $ | (8,686,573) | $ | (9,446,762) | $ | (2,049,878) | $ | (2,000,960) | |||||||
| Loss per ADS | |||||||||||||||
| Basic | $ | (9.64) | $ | (46.81) | $ | (2.08) | $ | (4.95) | |||||||
| Fully-diluted | $ | (9.64) | $ | (46.81) | $ | (2.08) | $ | (4.95) | |||||||
| Weighted average number of ADS's outstanding | |||||||||||||||
| Basic | 900,919 | 201,826 | 987,220 | 403,884 | |||||||||||
| Fully-diluted | 900,919 | 201,826 | 987,220 | 403,884 | |||||||||||
| 截至12月31日的年度 | 截至12月31日的三個月 | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| （已審計） | （已審計） | （未經審計） | （未經審計） | ||||||||||||
| 運營費用 | |||||||||||||||
| 一般和行政 | $ | 6,070,517 | $ | 6,584,868 | $ | 1,385,276 | $ | 1,472,866 | |||||||
| 研究和開發 | 3,307,987 | 2,672,836 | 832,391 | 613,067 | |||||||||||
| 運營費用總額 | 9,378,504 | 9,257,704 | 2,217,667 | 2,085,933 | |||||||||||
| 其他（收入）和支出 | |||||||||||||||
| 免除應付賬款 | - | (416,000) | - | - | |||||||||||
| 認股權證負債（收入）支出 | - | (77,237) | - | - | |||||||||||
| 未實現虧損（收益） | 2683 | (1,307) | (9,243) | (4,360) | |||||||||||
| 已實現和應計利息收入 | (694,614) | (95,745) | (158,546) | (80,613) | |||||||||||
| 利息和融資費用 | - | 714,081 | - | - | |||||||||||
| 其他（收入）支出總額 | (691,931) | 123,792 | (167,789) | (84,973) | |||||||||||
| 淨虧損 | $ | (8,686,573) | $ | (9,381,496) | $ | (2,049,878) | $ | (2,000,960) | |||||||
| 認股權證修改後的視作股息 | - | (65,266) | - | - | |||||||||||
| 歸屬於股東的淨虧損 | $ | (8,686,573) | $ | (9,446,762) | $ | (2,049,878) | $ | (2,000,960) | |||||||
| 每股ADS的虧損 | |||||||||||||||
| 基本 | $ | (9.64) | $ | (46.81) | $ | (2.08) | $ | (4.95) | |||||||
| 完全稀釋 | $ | (9.64) | $ | (46.81) | $ | (2.08) | $ | (4.95) | |||||||
| ADS 未償還的加權平均數 | |||||||||||||||
| 基本 | 900,919 | 201,826 | 987,220 | 403,884 | |||||||||||
| 完全稀釋 | 900,919 | 201,826 | 987,220 | 403,884 | |||||||||||
譯文內容由第三人軟體翻譯。