Quoin Pharmaceuticals Files 8-K

TL;DR

Quoin Pharma filed an 8-K on 10/21/25, former names Cellect Biotech/Biomed.

AI Summary

Quoin Pharmaceuticals, Ltd. filed an 8-K on October 21, 2025, reporting on various events including financial statements and exhibits. The company, formerly known as Cellect Biotechnology Ltd. and Cellect Biomed Ltd., is incorporated in Israel and operates in the pharmaceutical preparations sector.

Why It Matters

This filing provides an update on Quoin Pharmaceuticals' corporate activities and financial reporting, which is crucial for investors to assess the company's current status and future prospects.

Risk Assessment

Risk Level: low — This is a routine filing of an 8-K, not indicating any immediate material adverse events.

Key Players & Entities

• Quoin Pharmaceuticals, Ltd. (company) — Filer
• Cellect Biotechnology Ltd. (company) — Former company name
• Cellect Biomed Ltd. (company) — Former company name
• October 21, 2025 (date) — Date of earliest event reported

FAQ

Filing Documents

• tm2529207d1_8k.htm (8-K) — 33KB
• tm2529207d1_ex99-1.htm (EX-99.1) — 10KB
• 0001104659-25-101269.txt ( ) — 208KB
• qnrx-20251021.xsd (EX-101.SCH) — 3KB
• qnrx-20251021_lab.xml (EX-101.LAB) — 33KB
• qnrx-20251021_pre.xml (EX-101.PRE) — 22KB
• tm2529207d1_8k_htm.xml (XML) — 4KB

01. Regulation

Item 7.01. Regulation FD Disclosure. On October 21, 2025, Quoin Pharmaceuticals Ltd. (the "Company" or "Quoin") issued a press release announcing that the U.S. Food and Drug Administration (the "FDA") has granted Orphan Drug Designation to the Company's lead product candidate, QRX003, for the treatment of Netherton Syndrome. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (the "Report") and is incorporated by reference herein. The information in this

01 and Exhibit 99.1 attached hereto are furnished and shall not be deemed to be "filed" with the Securities

Item 7.01 and Exhibit 99.1 attached hereto are furnished and shall not be deemed to be "filed" with the Securities and Exchange Commission (the "SEC") for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

01. Other

Item 8.01. Other Events. On October 21, 2025, the Company announced that the FDA has granted Orphan Drug Designation to the Company's lead product candidate, QRX003, for the treatment of Netherton Syndrome. The designation follows previously granted Orphan Drug Designation by the European Medicines Agency (the "EMA") in May 2025. The FDA's Orphan Drug Designation program provides orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the United States. This designation provides certain benefits, including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees and seven years of market exclusivity, if approved. QRX003 is on track to potentially become the first approved treatment for Netherton Syndrome. QRX003 lotion (4%) is being evaluated in two late-stage whole body pivotal clinical trials for Netherton Syndrome. Enrollment in both pivotal studies is expected to be completed in the first quarter of 2026, top-line data is anticipated in the second half of 2026, and a new drug application ("NDA") submission is planned later in the year. Cautionary Note Regarding Forward Looking Statements The Company cautions that statements in this Report that are not descriptions 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," "hope," "plan," "potential," "anticipate," "look forward," "believe," "may," and "will," among others. All statements that reflect the Company's expectations, assumptions, projections, beliefs, or opinions about the future, other than track to potentially become the first approved treatment

01. Financial

Item 9.01. Financial (d) Exhibits. The following exhibits are filed or furnished, as applicable, with this Report: Exhibit Number Description 99.1 Press Release of the Company, dated October 21, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized. Date: October 21, 2025 QUOIN PHARMACEUTICALS LTD. By: /s/ Michael Myers Name: Dr. Michael Myers Title: Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR