Quoin Pharmaceuticals, Ltd.

Current report

There can be no assurance that we will be able to maintain compliance with Nasdaq’s Minimum Bid Price Requirement or other continued listing requirements. As of September 30, 2025, our stockholders’ equity was below the minimum requirement of $2,500,000 set forth in Nasdaq Listing Rule 5550(b)(1). Although the Private Placement, which closed on October 14, 2025, likely increased our stockholders’ equity, there can be no assurance that we will regain compliance with the stockholder’s equity requirement. If we fail to comply with the Nasdaq listing requirements and do not regain compliance, our ADSs will be subject to delisting by Nasdaq. In the event our ADSs are delisted, our ADS price and market liquidity of our ADSs will be adversely affected, which will impact our ability to sell securities in the market. Further, delisting from Nasdaq could also have other negative effects, including potential loss of confidence by partners, suppliers and employees.

Current report

There can be no assurance that our ADSs will continue to trade on Nasdaq or trade on the over-the counter markets or any public market in the future. In the event our ADSs are delisted, our ADS price and market liquidity of our ADSs will be adversely affected which will impact your ability to sell your securities in the market.

Current report

We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain marketing approval for one or more of our product candidates or these candidates participate in Early Access or Named Patient programs, which we expect will take a number of years and is subject to significant uncertainty. Additional financing will be required to complete the research and development of our product candidates and our other operating requirements, which may not be available at acceptable terms, if at all. If we are unable to obtain additional funding when it becomes necessary, the development of our product candidates will be impacted and we would likely be forced to delay, reduce, or terminate some or all of our development programs, all of which could have a material adverse effect on our business, results of operations and financial condition.

Current report

Limits on our ability to sell securities under the Purchase Agreements may affect our ability to finance our operations.

Current report

Pursuant to the terms of the Purchase Agreement that we entered into in connection with the Private Placement that closed on October 14, 2025, we agreed, subject to certain exceptions, (i) to not enter into variable rate financings for a period of 180 days following the Closing Date, (ii) to not enter into any equity financings until the later of 60 days after the effective date of the initial registration statement required to be filed pursuant to the Registration Rights Agreement (or, if earlier, if all applicable securities have been sold, or could be sold without restriction, pursuant to Rule 144 or Section 4(a)(1)) and 90 days after the Closing Date (the “Initial Standstill Period”), and (iii) to not enter into any equity financings at an effective price per ADS or Ordinary Share that is less than $8.25 from the last day of the Initial Standstill Period until 180 days after the effective date of the initial registration statement required to be filed pursuant to the Registration Rights Agreement (or, if earlier, if all applicable securities have been sold, or could be sold without restriction, pursuant to Rule 144 or Section 4(a)(1)). The Purchase Agreement further provides that the Purchasers have a right of participation in certain subsequent financings by us or any of our subsidiaries in an amount equal to up to an aggregate of 25% of such subsequent financings for 12 months following the date of the Purchase Agreement. If we require additional funding while these restrictive covenants remain in effect, we may be unable to effect a financing transaction on terms acceptable to us, or at all, while also remaining in compliance with the terms of the Purchase Agreement, or we may be forced to seek a waiver from the Purchasers, which such Purchasers are not obligated to grant to us.If we are unable to obtain additional funding when it becomes necessary, the development of our product candidates will be impacted, which could have a material adverse effect on our business.

Current report

Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved, which would harm our business. These changes have been reported by some within the pharmaceutical industry as creating instances of delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all.

Current report

If the current U.S. federal government shutdown is prolonged or if the FDA, NIH, SEC or the USPTO experiences significant decreases in funding or personnel, it could significantly impact the ability of the FDA to issues licenses needed for conduct of our clinical trials, the NIH to conduct research or provide grants, and the abilities of the FDA and the USPTO to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Previous report

There can be no assurance that we will be able to maintain compliance with Nasdaq’s Minimum Bid Price Requirement for continued listing. If our ADSs are delisted from Nasdaq, it will have a material negative impact on the actual and potential liquidity of our securities, as well as a material negative impact on our ability to raise future capital.

Previous report

We must raise additional capital to fund our operations in order to continue as a going concern.

Previous report

As of June 30, 2025, we had an accumulated deficit of $62.7 million. As of June 30, 2025, our cash and cash equivalents and investments were $7.8 million. Despite our recent financing in December 2024, pursuant to which we raised gross proceeds of approximately $6.8 million, based on our current expected level of operating expenditures we believe our cash and cash equivalents and investments on hand, management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of at least one year from the issuance of the unaudited consolidated financial statements included in this report. We will need to raise further capital through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants, or other arrangements to support our future operations. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain marketing approval for one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. If we are unable to improve our liquidity position, we may not be able to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate revenue and raise capital from financing transactions. There can be no assurance that we will be successful in accomplishing these objectives. Without such additional capital, we may be required to curtail or cease operations and be required to realize our assets and discharge our liabilities other than in the normal course of business which could cause investors to suffer the loss of all or a substantial portion of their investment.

Previous report — wording carried elsewhere

market liquidity of our ADS, decrease securities analysts’ coverage of us or diminish investor, supplier and employee confidence. In addition, our stock could become a “penny stock,” which would make trading of our ADS more difficult.