Quoin Pharmaceuticals Provides Corporate Update, Announces Q1 2024 Financial Results

Quoin Pharmaceuticals, Inc.

FDA Clearance to Recruit Adolescents in Both Ongoing Netherton Syndrome Clinical Trials

US and international patent filed for new product combined with Netherton Syndrome

Money runway extended until end of 2025

ASHBURN, Va., May 9, 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.

Quoin CEO Dr. Michael Myers said: “We are pleased to announce this encouraging start to 2024 as over the past quarter we have successfully built on the positive momentum of the past year. Following a series of protocol changes in both of our ongoing clinical studies in subjects with Netherton Syndrome, we believe we have increased the potential for a successful outcome. All protocol changes, which were based on positive initial clinical data, were approved by the FDA and have now been fully implemented. The changes include increasing the size of the open-label and blinded studies to 20 and 30 subjects, respectively, modifying the dosing frequency from once daily to twice daily, eliminating the lowest blinded study dose, and lowering the age of eligibility for fourteen years. and older. Combined, the two studies will test a total of 50 Netherton subjects, with more than 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 that the data set from both clinical studies could be sufficiently robust and comprehensive to support an NDA application, without the need for any additional clinical studies in Netherton subjects.

During the quarter, we expanded our intellectual property portfolio by filing U.S. and international patent applications for a new combination product as a treatment for Netherton Syndrome. We continue to explore additional patent opportunities for the product, both in the clinical area and in the manufacturing of the active ingredient and finished product. Finally, through the combination of a successful public offering and the execution of an equity line of credit agreement, we extended our cash flow until the end of 2025, which is well beyond a number of potentially significant milestones for the company.

Recent corporate highlights –

• On March 4, Quoin announced FDA authorization to recruit adolescents for both ongoing Netherton Syndrome clinical trials.

• On March 5, Quoin completed a public bond offering with gross proceeds of $6.5 million.

The story continues

• On February 8, Quoin filed U.S. and international patent applications for a new combination product for Netherton Syndrome.

• On January 25, Quoin signed an equity line of credit with Alumni Capital for up to $8 million, which was approved by shareholders on April 5, 2024.

Financial Highlights

• 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 .

About 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 meeting the unmet medical needs of 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.

Cautionary Note Regarding Forward-Looking Statements

The Company cautions you 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 can be identified by the use of words that reference 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 regarding the Company’s expected cash flow, the belief that the data set from both clinical studies could 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 increased the potential for a successful outcome successful 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 on the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and 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 earlier than planned, clinical studies may not generate data 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 . You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date they were made, except as required by law.

For more information:

PCG Advisory
Jeff Ramson
646-863-6893
jramson@pcgadvisory.com

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