QUOIN PHARMACEUTICALS LTD.

QUOIN PHARMACEUTICALS LTD._June 30, 2025

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________ to __________

Commission file number: 001-37846

QUOIN PHARMACEUTICALS LTD.

(Exact name of registrant as specified in its charter)


State of Israel		92-2593104
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)



42127 Pleasant Forest Court
Ashburn, VA		20148-7349
(Address of principal executive offices)		(Zip Code)

(703) 980-4182

(Registrant’s telephone number, including area code)

N/A

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
American Depositary Shares, each representing thirty-five (35) Ordinary Shares, no par value per share	QNRX	The Nasdaq Stock Market LLC
Ordinary Shares, no par value per share*		N/A

*	Not for trading, but only in connection with the registration of the American Depositary Shares (“ADSs”) pursuant to requirements of the Securities and Exchange Commission.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 6, 2025, the registrant had 20,585,830 ordinary shares, no par value per share, outstanding, and 588,166 ADSs outstanding, with each ADS representing thirty-five (35) ordinary shares.

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QUOIN PHARMACEUTICALS LTD.

INDEX

	Page
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS	1

PART I-FINANCIAL INFORMATION	3

Item 1. Financial Statements.	3

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.	17

Item 3. Quantitative and Qualitative Disclosures About Market Risk.	24

Item 4. Controls and Procedures.	25

PART II-OTHER INFORMATION	26

Item 1. Legal Proceedings.	26

Item 1A. Risk Factors.	26

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.	28

Item 3. Defaults Upon Senior Securities.	28

Item 4. Mine Safety Disclosures.	28

Item 5. Other Information.	28

Item 6. Exhibits.	29

SIGNATURES	30

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GENERAL INFORMATION

Unless otherwise indicated or the context otherwise requires, all references in this Quarterly Report on Form 10-Q (the “Quarterly Report”) to the terms “Quoin,” “Quoin Ltd.,” the “Company,” “us,” “we”, “our” and the “Registrant” refer to Quoin Pharmaceuticals Ltd., an Israeli company, and its consolidated subsidiaries. In this Quarterly Report, the U.S. Securities and Exchange Commission is referred to as the “SEC”, the Securities Act of 1933, as amended, is referred to as the “Securities Act” and the Securities Exchange Act of 1934, as amended, is referred to as the “Exchange Act.”

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

AND SUMMARY OF RISK FACTORS

Certain information included in this Quarterly Report may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Forward-looking statements are often characterized by the use of forward-looking terminology such as “may,” “will,” “expect,” “anticipate,” “estimate,” “continue,” “believe,” “should,” “intend,” “project” or other similar words, but are not the only way these statements are identified.

These forward-looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, statements that contain projections of results of operations or of financial condition, expected capital needs and expenses, statements relating to the research, development, completion and use of our products, and all statements (other than statements of historical facts) that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future.

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things:

●

our limited operating history and the difficulties encountered by a small developing company;

●

our history of losses and need for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all;

●

we must raise additional capital to fund our operations in order to continue as a going concern;

●

our lack of revenue and potential inability to be profitable;

●

uncertainties of cash flows and inability to meet working capital needs;

●

our ability to obtain regulatory approvals;

●

our ability to generate favorable pre-clinical and clinical trial results;

●

our ability to identify and develop potential product candidates;

●

additional costs or delays associated with unsuccessful clinical trials;

●

the inability to predict the timing of revenue from sales of a future product;

●

the extensive regulatory requirements and future developmental and regulatory challenges we will still face even if we obtain approval for a product candidate;

●

our ability to obtain or maintain orphan drug designation or data exclusivity for our product candidates;

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●

our ability to obtain Orphan Disease and Rare Pediatric Disease designations for our product candidates;

●

the potential oversight of programs or product candidates that may be more profitable or more successful;

●

our manufacturing processes may not be validated and our methodology may not be accepted by the scientific community;

●

the ability to conduct clinical trials, because of difficulties enrolling patients or other reasons;

●

the requirements of being a publicly traded company may strain our resources;

●

potential adverse effects resulting from failure to maintain effective internal controls;

●

our ability to comply with the applicable continued listing requirements of Nasdaq;

●

the potential negative impact on our securities price and trading volume if securities or industry analysts do not publish reports about us or if they adversely change their recommendations about our business;

●

the potential volatility of the market price for our ADSs;

●

the potential dilution of our shareholders’ potential ownership due to future issuances of share capital;

●

the requirement for holders of ADSs to act through the depositary to exercise their rights;

●

the potential limitations on ADS holders with respect to the transfer of their ADSs;

●

the risks of securities class action litigation; and

●

other risks and uncertainties, including those listed under described in Part I – Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024 (“Form 10-K”), as well as our subsequent reports filed with the SEC.

You are urged to carefully review and consider the various disclosures made throughout this Quarterly Report which are designed to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.

You should not put undue reliance on any forward-looking statements. Although the forward-looking statements in this Quarterly Report are based on our beliefs, assumptions and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements or outcomes. No assurance can be made that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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PART I – FINANCIAL INFORMATION

Item 1. Financial Statements.

QUOIN PHARMACEUTICALS LTD.

Condensed Consolidated Balance Sheets


	June 30,		December 31,
	2025		2024
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	1,668,492	$	3,623,343
Investments		6,121,830		10,433,535
Prepaid expenses and other current assets		688,933		869,126
Total current assets		8,479,255		14,926,004
Prepaid expenses - long term		—		300,000
Intangible assets, net		433,334		483,334
Total assets	$	8,912,589	$	15,709,338

LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	873,684	$	905,704
Accrued expenses		1,717,564		1,528,977
Accrued interest and financing expense		1,146,251		1,146,251
Due to officers - short term		600,000		600,000
Total current liabilities		4,337,499		4,180,932

Due to officers - long term		2,023,733		2,323,733
Total liabilities	$	6,361,232	$	6,504,665

Commitments and contingencies

Shareholders’ equity:
Ordinary shares, no par value per share, 100,000,000 ordinary shares authorized at June 30, 2025 and December 31, 2024, respectively - 20,585,830 (588,166 ADS’s) ordinary shares issued and outstanding at June 30, 2025 and 8,948,164 (255,661 ADS’s) ordinary shares issued and outstanding at December 31, 2024	$	—	$	—
Additional paid in capital		65,225,266		64,370,465
Accumulated deficit		(62,673,909)		(55,165,792)
Total shareholders’ equity		2,551,357		9,204,673

Total liabilities and shareholders’ equity	$	8,912,589	$	15,709,338

The accompanying footnotes are an integral part of these unaudited condensed consolidated financial statements

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QUOIN PHARMACEUTICALS LTD.

Condensed Consolidated Statements of Operations (Unaudited)


	Three months ended June 30,				Six months ended June 30,
	2025		2024		2025		2024
Operating expenses
General and administrative	$	1,742,594	$	1,549,615	$	3,325,632	$	3,122,601
Research and development		2,050,585		587,503		4,424,724		1,472,801

Total operating expenses		3,793,179		2,137,118		7,750,356		4,595,402

Other (income) and expenses
Unrealized loss		6,004		2,177		5,878		8,686
Realized and accrued interest income		(103,245)		(165,262)		(248,117)		(302,775)
Total other income		(97,241)		(163,085)		(242,239)		(294,089)
Net loss	$	(3,695,938)	$	(1,974,033)	$	(7,508,117)	$	(4,301,313)

Loss per ADS
Loss per ADS
Basic	$	(6.28)	$	(13.68)	$	(12.79)	$	(42.09)
Fully-diluted	$	(6.28)	$	(13.68)	$	(12.79)	$	(42.09)

Weighted average number of ADS’s outstanding
Basic		588,166		144,278		587,253		102,186
Fully-diluted		588,166		144,278		587,253		102,186

The accompanying footnotes are an integral part of these unaudited condensed consolidated financial statements

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QUOIN PHARMACEUTICALS LTD.

Condensed Consolidated Statements of Shareholders’ Equity (Unaudited)

Three and six months ended June 30, 2024


			Additional
	Ordinary		Paid in		Accumulated
	Shares	ADS’s	Capital		Deficit		Total
Balance at January 1, 2024	987,220	28,206	$	51,867,336	$	(46,203,320)	$	5,664,016
Net loss	—	—		—		(2,327,280)		(2,327,280)
Issuance of ADS’s, pre-funded warrants and warrants, net	2,808,750	80,250		5,482,472		—		5,482,472
Stock based compensation	—	—		306,314		—		306,314
Balance at March 31, 2024	3,795,970	108,456	$	57,656,122	$	(48,530,600)	$	9,125,522
Net loss	—	—		—		(1,974,033)		(1,974,033)
Exercise of pre-funded warrants	184,000	5,257		18		—		18
Reversal of accrued offering expenses	—	—		13,707		—		13,707
Stock based compensation	—	—		313,122		—		313,122
Balance at June 30, 2024	3,979,970	113,713	$	57,982,969	$	(50,504,633)	$	7,478,336

Three and six months ended June 30, 2025


			Additional
	Ordinary		Paid in		Accumulated
	Shares	ADS’s	Capital		Deficit		Total
Balance at January 1, 2025	8,948,164	255,661	$	64,370,465	$	(55,165,792)	$	9,204,673
Net loss	—	—		—		(3,812,179)		(3,812,179)
Exercise of pre-funded warrants and warrants, net	11,637,666	332,505		172,958		—		172,958
Stock based compensation	—	—		360,357		—		360,357
Balance at March 31, 2025	20,585,830	588,166	$	64,903,780	$	(58,977,971)	$	5,925,809
Net loss	—	—		—		(3,695,938)		(3,695,938)
Stock based compensation	—	—		321,486		—		321,486
Balance at June 30, 2025	20,585,830	588,166	$	65,225,266	$	(62,673,909)	$	2,551,357

The accompanying footnotes are an integral part of these unaudited condensed consolidated financial statements

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QUOIN PHARMACEUTICALS LTD.

Condensed Consolidated Statements of Cash Flows (unaudited)


	Six Months Ended June 30,
	2025		2024
Cash flows used in operating activities:
Net loss	$	(7,508,117)	$	(4,301,313)
Stock based compensation		681,843		619,436
Amortization of intangibles		50,000		50,000
Realized and unrealized gain and accrued interest on investments		(140,996)		(121,026)
Changes in assets and liabilities:
Increase in accounts payable and accrued expenses		156,567		371,070
Decrease (increase) in prepaid expenses and other assets		480,193		(59,662)
Net cash used in operating activities	$	(6,280,510)	$	(3,441,495)

Cash flows provided (used) in investing activities:
Purchase of investments	$	—	$	(9,649,774)
Proceeds from redemption of investments		4,452,701		8,339,000
Net cash provided (used) in investing activities	$	4,452,701	$	(1,310,774)

SEC Form 10-Q filed by Quoin Pharmaceuticals Ltd.