Quoin Pharmaceuticals Provides Corporate Update and Announces First Quarter 2024 Financial Results
Quoin Pharmaceuticals Provides Corporate Update and Announces First Quarter 2024 Financial Results
FDA clearance to recruit teens in both on-going Netherton Syndrome clinical studies
美國食品藥品管理局批准在兩項正在進行的內瑟頓綜合症臨床研究中招募青少年
U.S. and International patent filed for novel Netherton Syndrome combination product
新型內瑟頓綜合症組合產品已申請美國和國際專利
Cash runway extended into late 2025
現金流延至2025年底
ASHBURN, Va., May 09, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a clinical stage, specialty pharmaceutical company focused on developing and commercializing novel treatments for rare and orphan diseases, today provides a business update and announces financial results for the first quarter ended March 31, 2024.
弗吉尼亞州阿什本，2024年5月9日（GLOBE NEWSWIRE）——專注於開發和商業化罕見病和孤兒病新療法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”）今天提供了業務最新情況，並公佈了截至2024年3月31日的第一季度財務業績。
Quoin CEO, Dr. Michael Myers, said, "We are pleased to announce this encouraging start to 2024 as throughout the past quarter we successfully built upon the positive momentum from last year. Following a series of protocol amendments to both of our ongoing clinical studies in Netherton Syndrome subjects, we believe we have enhanced the potential for a successful outcome. All of the protocol amendments, which were based on positive initial clinical data, have been cleared by the FDA and have now been fully implemented. The amendments include increasing the size of the open-label and blinded studies to 20 and 30 subjects respectively, modifying dosing frequency to twice-daily from once-daily, eliminating the lower dose from the blinded study and reducing the age of eligibility to fourteen years and older. Combined the two studies will test a total of 50 Netherton subjects with over 30 of those tested being treated with QRX003 at the target commercial dose, either as monotherapy or in conjunction with systemic biologics. The Company believes the data set from both clinical studies could potentially be sufficiently robust and comprehensive to support an NDA filing, without the need for any additional clinical studies in Netherton subjects.
Quoin首席執行官邁克爾·邁爾斯博士表示：“我們很高興地宣佈，2024年開局令人鼓舞，因爲在過去一個季度中，我們成功地在去年的積極勢頭基礎上再接再厲。在對我們正在進行的內瑟頓綜合症受試者的兩項臨床研究進行了一系列協議修正之後，我們認爲我們已經增強了取得成功結果的可能性。所有基於積極的初始臨床數據的協議修正案均已獲得美國食品藥品管理局的批准，現已全面實施。修正案包括將開放標籤和盲目研究的規模分別擴大到20和30名受試者，將給藥頻率從每天一次修改爲每天兩次，取消盲目研究中的較低劑量，並將合格年齡降低到十四歲及以上。這兩項研究將對總共 50 名 Netherton 受試者進行測試，其中 30 多名受試者正在接受目標商業劑量的 QRX003 治療，可以是單一療法，也可以與全身生物製劑聯合使用。該公司認爲，這兩項臨床研究的數據集可能足夠可靠和全面，足以支持NDA的申請，而無需對Netherton受試者進行任何額外的臨床研究。
During the quarter, we expanded our intellectual property portfolio by the filing of US and International patent applications for a novel combination product as a treatment for Netherton Syndrome. We continue to explore additional patent opportunities for the product in both clinical and in the manufacturing of the active ingredient and finished product. Finally, via the combination of a successful public offering and the execution of an equity line of credit arrangement, we have extended our cash runway into late 2025, which is well beyond a number of potentially significant milestones for the Company.
在本季度，我們通過提交一種治療內瑟頓綜合症的新型組合產品的美國和國際專利申請，擴大了我們的知識產權組合。我們將繼續探索該產品在臨床以及活性成分和成品製造中的其他專利機會。最後，通過成功的公開募股和執行股票信貸額度安排相結合，我們將現金流延至2025年底，這遠遠超過了公司許多潛在的重大里程碑。
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 March 5th, Quoin completed a public offering of securities with gross proceeds of $6.5 million.
- 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。
- 3 月 5 日第四，Quoin完成了證券的公開發行，總收益爲650萬美元。
- On February 8th, Quoin filed U.S. and International patent applications for a novel Netherton Syndrome combination product.
- On January 25, Quoin Signed an equity line of credit with Alumni Capital for up to $8 million that was approved by shareholders on April 5th 2024.
- 2 月 8 日第四，Quoin爲一種新型內瑟頓綜合症組合產品提交了美國和國際專利申請。
- 1月25日，Quoin與Alumni Capital簽署了高達800萬美元的股權信貸額度，該信貸額度於4月5日獲得股東的批准第四 2024。
Financial Highlights
財務要聞
- Quoin had approximately $14.7 million in cash, cash equivalents and marketable securities as of March 31, 2024.
- Net loss for the quarter ended March 31, 2024 was approximately $2.3 million compared to approximately $2.6 million for the quarter ended March 31, 2023.
- Investors are encouraged to read the Company's Report on Form 10-Q 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 March 31, 2024.
- 截至2024年3月31日，Quoin擁有約1,470萬美元的現金、現金等價物和有價證券。
- 截至2024年3月31日的季度淨虧損約爲230萬美元，而截至2023年3月31日的季度淨虧損約爲260萬美元。
- 鼓勵投資者閱讀公司向美國證券交易委員會（“SEC”）提交的10-Q表報告，該報告將包含有關Quoin截至2024年3月31日的財務業績的更多細節。
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 the data set from both clinical studies could potentially be sufficiently robust and comprehensive to support an NDA filing, without the need for any additional clinical studies in Netherton subjects, and the belief that certain protocol changes has enhanced the potential for a successful outcome and Quoin's products in development 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. 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 including, but not limited to, the Company may need to raise additional funds sooner than planned, the clinical studies may not generate data which is sufficiently robust and comprehensive to support an NDA filing and the Company's ability to obtain regulatory approvals. More detailed information about the risks and uncertainties affecting the Company is summarized in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings the Company has made and may make with the SEC in the future. 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，認爲兩項臨床研究的數據集可能足夠可靠和全面，足以支持保密協議申報，無需對Netherton受試者進行任何額外的臨床研究，以及認爲某些協議變更增強了NDA申報取得成功的潛力和Quoin正在開發的產品共同有可能靶向大量罕見和孤兒適應症，包括內瑟頓綜合症、皮膚脫皮綜合症、掌瓣角膜病、硬皮病、大皰性表皮鬆解症等。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，這些風險和不確定性包括但不限於公司可能需要比計劃更早籌集額外資金、臨床研究可能無法產生足夠可靠和全面的數據來支持保密協議申報以及公司獲得監管部門批准的能力。公司截至2023年12月31日止年度的10-K表年度報告以及公司已經和將來可能向美國證券交易委員會提交的其他文件中總結了有關影響公司的風險和不確定性的更多詳細信息。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
Jeff Ramson
646-863-6893
jramson@pcgadvisory.com
PCG 諮詢
傑夫·拉姆森
646-863-6893
jramson@pcgadvisory.com
-Tables Follow-
-表格如下-
| QUOIN PHARMACEUTICALS, LTD. | |||||||||||
| Consolidated Balance Sheets | |||||||||||
| March 31, | December 31, | ||||||||||
| 2024 | 2023 | ||||||||||
| (unaudited) | |||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 1,833,524 | $ | 2,401,198 | |||||||
| Investments | 12,856,448 | 8,293,663 | |||||||||
| Prepaid expenses and other current assets | 574,904 | 591,034 | |||||||||
| Total current assets | 15,264,876 | 11,285,895 | |||||||||
| Prepaid expenses - long term | 300,000 | 300,000 | |||||||||
| Intangible assets, net | 558,334 | 583,334 | |||||||||
| Total assets | $ | 16,123,210 | $ | 12,169,229 | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 358,510 | $ | 526,523 | |||||||
| Accrued expenses | 2,119,194 | 1,308,706 | |||||||||
| Accrued interest and financing expense | 1,146,251 | 1,146,251 | |||||||||
| Due to officers - short term | 600,000 | 600,000 | |||||||||
| Total current liabilities | 4,223,955 | 3,581,480 | |||||||||
| Due to officers - long term | 2,773,733 | 2,923,733 | |||||||||
| Total liabilities | $ | 6,997,688 | $ | 6,505,213 | |||||||
| Shareholders' equity: | |||||||||||
| Ordinary shares, no par value per share, 100,000,000 ordinary shares authorized at | $ | - | $ | - | |||||||
| March 31, 2024 and December 31, 2023, respectively - 3,795,970 (3,795,970 ADS's) ordinary shares issued and outstanding at March 31, 2024 and 987,220 (987,220 ADS's) at December 31, 2023 | |||||||||||
| Additional paid in capital | 57,656,122 | 51,867,336 | |||||||||
| Accumulated deficit | (48,530,600) | (46,203,320) | |||||||||
| Total shareholders' equity | 9,125,522 | 5,664,016 | |||||||||
| Total liabilities and shareholders' equity | $ | 16,123,210 | $ | 12,169,229 | |||||||
| 昆明製藥有限公司 | |||||||||||
| 合併資產負債表 | |||||||||||
| 3月31日 | 十二月三十一日 | ||||||||||
| 2024 | 2023 | ||||||||||
| （未經審計） | |||||||||||
| 資產 | |||||||||||
| 流動資產： | |||||||||||
| 現金和現金等價物 | $ | 1,833,524 | $ | 2,401,198 | |||||||
| 投資 | 12,856,448 | 8,293,663 | |||||||||
| 預付費用和其他流動資產 | 574,904 | 591,034 | |||||||||
| 流動資產總額 | 15,264,876 | 11,285,895 | |||||||||
| 預付費用-長期 | 300 | 300 | |||||||||
| 無形資產，淨額 | 558,334 | 583,334 | |||||||||
| 總資產 | $ | 16,123,210 | $ | 12,169,229 | |||||||
| 負債和股東權益 | |||||||||||
| 流動負債： | |||||||||||
| 應付賬款 | $ | 358,510 | $ | 526,523 | |||||||
| 應計費用 | 2,119,194 | 1,308,706 | |||||||||
| 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 | 4,223,955 | 3,581,480 | |||||||||
| 應歸於軍官——長期 | 2,773,733 | 2,923,733 | |||||||||
| 負債總額 | $ | 6,997,688 | $ | 6,505,213 | |||||||
| 股東權益： | |||||||||||
| 普通股，每股無面值，1億股普通股授權於 | $ | - | $ | - | |||||||
| 分別爲 2024 年 3 月 31 日和 2023 年 12 月 31 日——截至 2024 年 3 月 31 日已發行和流通的 3,795,970 股（3,795,970 股）普通股和 2023 年 12 月 31 日爲 987,220 股（987,220 ADS） | |||||||||||
| 額外已繳資本 | 57,656,122 | 51,867,336 | |||||||||
| 累計赤字 | (48,530,600) | (46,203,320) | |||||||||
| 股東權益總額 | 9,125,522 | 5,664,016 | |||||||||
| 負債和股東權益總額 | $ | 16,123,210 | $ | 12,169,229 | |||||||
| QUOIN PHARMACEUTICALS LTD. | ||||||||
| Consolidated Statements of Operations (unaudited) | ||||||||
|
Three months ended March 31, |
||||||||
| 2024 | 2023 | |||||||
| Operating expenses | ||||||||
| General and administrative | $ | 1,615,452 | $ | 1,683,817 | ||||
| Research and development | 842,832 | 1,091,733 | ||||||
| Total operating expenses | 2,458,284 | 2,775,550 | ||||||
| Other (income) and expenses | ||||||||
| Unrealized loss (gain) | 6,509 | (20,427) | ||||||
| Realized and accrued interest income | (137,513) | (152,054) | ||||||
| Total other income | (131,004) | (172,481) | ||||||
| Net loss | $ | (2,327,280) | $ | (2,603,069) | ||||
| Loss per ADS | ||||||||
| Basic | $ | (1.11) | $ | (4.09) | ||||
| Fully-diluted | $ | (1.11) | $ | (4.09) | ||||
| Weighted average number of ADS's outstanding | ||||||||
| Basic | 2,103,292 | 637,217 | ||||||
| Fully-diluted | 2,103,292 | 637,217 | ||||||
| QUOIN 製藥有限公司 | ||||||||
| 合併運營報表（未經審計） | ||||||||
| 截至3月31日的三個月 |
||||||||
| 2024 | 2023 | |||||||
| 運營費用 | ||||||||
| 一般和行政 | $ | 1,615,452 | $ | 1,683,817 | ||||
| 研究和開發 | 842,832 | 1,091,733 | ||||||
| 運營費用總額 | 2,458,284 | 2,775,550 | ||||||
| 其他（收入）和支出 | ||||||||
| 未實現虧損（收益） | 6,509 | (20,427) | ||||||
| 已實現和應計利息收入 | (137,513) | (152,054) | ||||||
| 其他收入總額 | (131,004) | (172,481) | ||||||
| 淨虧損 | $ | (2,327,280) | $ | (2,603,069) | ||||
| 每股ADS的虧損 | ||||||||
| 基本 | $ | (1.11) | $ | (4.09) | ||||
| 完全稀釋 | $ | (1.11) | $ | (4.09) | ||||
| ADS 未償還的加權平均數 | ||||||||
| 基本 | 2,103,292 | 637,217 | ||||||
| 完全稀釋 | 2,103,292 | 637,217 | ||||||