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
在正在进行的开放标签内瑟顿综合征研究中，公司报告了前六名可评估受试者的 QRX003 初步临床数据为阳性，在多个临床终点中观察到积极的益处
Eligibility age for enrollment into both studies has been lowered to fourteen years and older
两项研究的入学资格年龄已降至十四岁及以上
No safety concerns have been observed to date in either ongoing clinical study
迄今为止，在两项正在进行的临床研究中均未发现任何安全问题
Quoin expects its cash runway will extend into the second half of 2025 following $6.5 million offering on March 5th
Quoin预计，继3月5日发行650万美元之后，其现金流将延续到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日签署的800万美元股权信贷额度安排将进一步延长 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.
弗吉尼亚州阿什本，2024年3月13日（环球新闻专线）——专注于罕见病和孤儿病的临床阶段专业制药公司Quoin Pharmicals Ltd.（纳斯达克股票代码：QNRX）（“公司” 或 “Quoin”）今天提供了最新业务并公布了截至2023年12月31日的季度和年度的财务业绩。
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 首席执行官迈克尔·迈尔斯博士表示：“2023 年标志着 Quoin 和用于治疗内瑟顿综合症的 QRX003 的开发又取得重大进展的一年。值得注意的是，我们发布了开放标签临床研究的初步阳性数据，这对于服务严重不足的Netherton社区来说是第一次。这种进展仍在继续，基于初步的阳性临床数据，我们实施了许多重要的方案变更，我们认为这些变更可能会使总体开发计划更加简化。
"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."
“我们还通过最近完成的650万澳元融资，加强了资产负债表，一旦获得股东批准，我们有能力通过今年早些时候达成的800万美元股权信贷额度交易进一步巩固我们的现金状况。我们仍然相信，Quoin有能力为这种可怕的疾病提供第一种获得批准的治疗方法。”
Recent Corporate Highlights –
近期企业亮点 —
- 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宣布美国食品药品管理局批准招募青少年受试者参加两项正在进行的内瑟顿综合症临床研究。
- 2 月 8 日第四，2024年，Quoin为一种新的内瑟顿综合症组合产品提交了美国和国际专利申请。
- 在 12 月 13 日第四，Quoin 宣布美国食品药品管理局批准了内瑟顿综合症 QRX003 的临床优化计划
- 10 月 24 日第四，Quoin宣布了该公司针对内瑟顿综合症患者的开放标签临床试验中前六名可评估患者的积极临床数据。
- 六名受试者中有五名报告说，在使用 QRX003 治疗后，他们的瘙痒或瘙痒可以忽略不计或消失，与研究前相比有了显著改善。
- 所有六名受试者在研究人员评估的皮肤评分系统中均表现出改善，其中三名受试者在研究完成时表现出改善，另外三名受试者在研究期间的不同时刻表现出改善。
- 在多项评估指标中，所有六名受试者都对 QRX003 表示了良好的印象。
- 迄今为止，在Quoin的两项研究中，均未报告任何受试者的安全问题。
Financial Highlights
财务要闻
- 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拥有约1,070万美元的现金、现金等价物和有价证券。这不包括该公司于2024年3月5日宣布的650万美元普通股公开发行所得的收益，也不包括今年1月达成的800万美元股权信贷额度交易的预期收益。这项措施的实施仍需获得股东的批准。
- 截至2023年12月31日的季度净亏损约为200万美元，而截至2022年12月31日的季度净亏损约为200万美元。截至2023年12月31日的十二个月净亏损为870万美元，而截至2022年12月31日的十二个月净亏损为940万美元。
- 鼓励投资者阅读公司向美国证券交易委员会（“SEC”）提交的10-K表年度报告，该报告将包含有关Quoin截至2023年12月31日的财务业绩的更多细节。
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将于美国东部时间2024年3月14日星期四上午8点30分主持电话会议和网络直播。电话会议将包括对2023年第四季度和全年财务业绩的讨论以及公司最新情况。拨打1-800-603-0527（国内）或1-412-317-0688（国际）即可进行实时通话。电话会议的直播和存档网络直播也将在Quoin Pharmicals网站上的 “投资者” 栏目下或通过以下链接播出： https://event.choruscall.com/mediaframe/webcast.html?webcastid=ZmehVyN5
About Quoin Pharmaceuticals Ltd.
关于 Quoin 制药有限公司
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. 是一家临床阶段的专业制药公司，专注于开发和商业化治疗罕见病和孤儿病的治疗产品。我们致力于解决患者、他们的家人、社区和护理团队未得到满足的医疗需求。Quoin的创新产品线包括四种正在开发的产品，这些产品共同有可能靶向大量罕见和孤儿适应症，包括内瑟顿综合征、皮肤脱皮综合征、掌足角化病、硬皮病、大疱性表皮松解症等。欲了解更多信息，请访问： www.quoinpharma.com 要么 领英 用于更新。
Cautionary Note Regarding Forward Looking Statements
关于前瞻性陈述的警示说明
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.
该公司警告说，本新闻稿中未描述历史事实的陈述是1995年《私人证券诉讼改革法》所指的前瞻性陈述。前瞻性陈述可以通过使用提及未来事件或情况的词语来识别，例如 “期望”、“打算”、“计划”、“预测”、“相信” 和 “将” 等。除历史事实陈述外，所有反映公司对未来的预期、假设、预测、信念或观点的陈述均为前瞻性陈述，包括但不限于与公司预期现金流有关的陈述、某些协议变更可能导致更简化的开发计划的信念以及认为公司有能力提供第一种获批准的内瑟顿综合症疗法。由于此类陈述受风险和不确定性的影响，因此实际结果可能与此类前瞻性陈述所表达或暗示的结果存在重大差异。这些前瞻性陈述基于公司当前的预期，涉及可能永远无法实现或可能被证明不正确的假设。由于各种风险和不确定性，实际结果和事件发生时间可能与此类前瞻性陈述中的预期存在重大差异。有关影响公司的风险和不确定性的更多详细信息包含在公司向美国证券交易委员会提交的截至2023年12月31日止年度的10-K表年度报告中 “风险因素” 标题下。不应过分依赖这些前瞻性陈述，这些陈述仅代表发表之日。除非法律要求，否则公司没有义务更新此类声明以反映在声明发表之日后发生的事件或存在的情况。
For further information:
欲了解更多信息：
PCG Advisory
Stephanie Prince
sprince@pcgadvisory.com
(646) 863-6341
PCG 咨询
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-Tables Follow-
-表格如下-
QUOIN PHARMACEUTICALS LTD.
QUOIN 制药有限公司
Consolidated Balance Sheets
合并资产负债表
| 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 | |||||||
| 资产 | ||||||||
| 流动资产： | ||||||||
| 现金和现金等价物 | $ | 2,401,198 | $ | 2,860,628 | ||||
| 投资 | 8,293,663 | 9,992,900 | ||||||
| 预付费用和其他流动资产 | 591,034 | 516,584 | ||||||
| 流动资产总额 | 11,285,895 | 13,370,112 | ||||||
| 预付费用-长期 | 300 | 383,390 | ||||||
| 无形资产，净额 | 583,334 | 704,561 | ||||||
| 总资产 | $ | 12,169,229 | $ | 14,458,063 | ||||
| 负债和股东权益 | ||||||||
| 流动负债： | ||||||||
| 应付账款 | $ | 526,523 | $ | 605,600 | ||||
| 应计费用 | 1,308,706 | 1,175,705 | ||||||
| 应计利息和融资费用 | 1,146,251 | 1,146,251 | ||||||
| 应归于军官——短期 | 60万 | 60万 | ||||||
| 流动负债总额 | 3,581,480 | 3,527,556 | ||||||
| 应归于军官——长期 | 2,923,733 | 3,523,733 | ||||||
| 负债总额 | $ | 6,505,213 | $ | 7,051,289 | ||||
| 承付款和意外开支 | ||||||||
| 股东权益： | ||||||||
| 普通股，每股无面值，截至2023年12月31日和2022年12月31日分别授权的1亿股和8,333,334股普通股——987,220（987,220 ADS） | $ | - | $ | - | ||||
| 截至2023年12月31日已发行和流通的普通股和403,887股 | ||||||||
| 截至2022年12月31日（403,887 ADS） | ||||||||
| 库存股， | - | (2,932,000) | ||||||
| -0-2023年12月31日发行的普通股和2022年12月31日发行的45股普通股 | ||||||||
| 额外已缴资本 | 51,867,336 | 47,855,521 | ||||||
| 累计赤字 | (46,203,320) | (37,516,747) | ||||||
| 股东权益总额 | 5,664,016 | 7,406,774 | ||||||
| 负债和股东权益总额 | $ | 12,169,229 | $ | 14,458,063 | ||||
QUOIN PHARMACEUTICALS LTD.
QUOIN 制药有限公司
Consolidated Statements of Operations
合并运营报表
| 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日的三个月 | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| （已审计） | （已审计） | （未经审计） | （未经审计） | ||||||||||||
| 运营费用 | |||||||||||||||
| 一般和行政 | $ | 6,070,517 | $ | 6,584,868 | $ | 1,385,276 | $ | 1,472,866 | |||||||
| 研究和开发 | 3,307,987 | 2,672,836 | 832,391 | 613,067 | |||||||||||
| 运营费用总额 | 9,378,504 | 9,257,704 | 2,217,667 | 2,085,933 | |||||||||||
| 其他（收入）和支出 | |||||||||||||||
| 免除应付账款 | - | (416,000) | - | - | |||||||||||
| 认股权证负债（收入）支出 | - | (77,237) | - | - | |||||||||||
| 未实现亏损（收益） | 2683 | (1,307) | (9,243) | (4,360) | |||||||||||
| 已实现和应计利息收入 | (694,614) | (95,745) | (158,546) | (80,613) | |||||||||||
| 利息和融资费用 | - | 714,081 | - | - | |||||||||||
| 其他（收入）支出总额 | (691,931) | 123,792 | (167,789) | (84,973) | |||||||||||
| 净亏损 | $ | (8,686,573) | $ | (9,381,496) | $ | (2,049,878) | $ | (2,000,960) | |||||||
| 认股权证修改后的视作股息 | - | (65,266) | - | - | |||||||||||
| 归属于股东的净亏损 | $ | (8,686,573) | $ | (9,446,762) | $ | (2,049,878) | $ | (2,000,960) | |||||||
| 每股ADS的亏损 | |||||||||||||||
| 基本 | $ | (9.64) | $ | (46.81) | $ | (2.08) | $ | (4.95) | |||||||
| 完全稀释 | $ | (9.64) | $ | (46.81) | $ | (2.08) | $ | (4.95) | |||||||
| ADS 未偿还的加权平均数 | |||||||||||||||
| 基本 | 900,919 | 201,826 | 987,220 | 403,884 | |||||||||||
| 完全稀释 | 900,919 | 201,826 | 987,220 | 403,884 | |||||||||||