0001104659-23-116370.txt : 20231109 0001104659-23-116370.hdr.sgml : 20231109 20231109171023 ACCESSION NUMBER: 0001104659-23-116370 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20231108 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231109 DATE AS OF CHANGE: 20231109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Quoin Pharmaceuticals, Ltd. CENTRAL INDEX KEY: 0001671502 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37846 FILM NUMBER: 231393706 BUSINESS ADDRESS: STREET 1: 23 HATA'AS STREET CITY: KFAR SABA STATE: L3 ZIP: 44425 BUSINESS PHONE: 97299741444 MAIL ADDRESS: STREET 1: 23 HATA'AS STREET CITY: KFAR SABA STATE: L3 ZIP: 44425 FORMER COMPANY: FORMER CONFORMED NAME: Cellect Biotechnology Ltd. DATE OF NAME CHANGE: 20160721 FORMER COMPANY: FORMER CONFORMED NAME: Cellect Biomed Ltd. DATE OF NAME CHANGE: 20160406 8-K 1 tm2330370d1_8k.htm FORM 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 8, 2023

 

QUOIN PHARMACEUTICALS LTD.
(Translation of registrant’s name into English)

 

State of Israel   001-37846   92-2593104
(State or other jurisdiction
of incorporation)		   (Commission File Number)   (I.R.S. Employer
Identification No.)

 

42127 Pleasant Forest Court

Ashburn, VA

   20148-7349
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (703) 980-4182

 

Not applicable
(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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 one (1) Ordinary Share, 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 pursuant to requirements of the Securities and Exchange Commission.

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ¨

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On November 8, 2023, Quoin Pharmaceuticals Ltd. (the “Company”) announced its financial results for the quarter ended September 30, 2023. A copy of the Company’s press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.

 

The information set forth and incorporated by reference in this Item 2.02 shall not be deemed to be “filed” with the Securities and Exchange Commission 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, and the Company does not incorporate it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
No.		  Description
    
99.1  Press Release, dated November 8, 2023
104  Cover Page Interactive Data file (embedded within the Inline XBRL document)

 

 

 

 

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: November 9, 2023 QUOIN PHARMACEUTICALS LTD.
   
   
  By: /s/ Gordon Dunn
  Name: Gordon Dunn
  Title: Chief Financial Officer

 

 

 

 EX-99.1 2 tm2330370d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

Quoin Pharmaceuticals Provides Corporate Update and Announces Third Quarter 2023 Financial Results

 

Company reported positive clinical data for QRX003 from first six evaluable subjects in ongoing open-label Netherton Syndrome study

 

Positive benefits were observed across a number of clinical endpoints including pruritus, Investigator skin scoring system and patient global assessment.

 

No safety concerns have been observed to date in either ongoing clinical study

 

Quoin expects its cash runway will extend through the end of 2024

 

ASHBURN, Va., November 8, 2023 (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 ended September 30, 2023.

 

Quoin CEO, Dr. Michael Myers, said, “While still early-stage, we are extremely excited by the positive clinical data generated to date across a number of endpoints from our ongoing open-label clinical study in Netherton Syndrome patients. We are particularly pleased with the pruritus results observed for five of the six subjects evaluated. Given the overall strong efficacy data and the exemplary safety profile demonstrated thus far, we are moving into an optimization phase for both of our Netherton Syndrome studies, which we believe could lead to an even more robust clinical data set.”

 

Corporate Highlights –

 

●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 evaluated had negligible or absent pruritus, or itch, 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 throughout 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.

 

 

 

 

●Company plans to further optimize its clinical program by making a number of protocol amendments including: eliminating the lower 2% dose in the double blinded study, changing the dosing frequency to twice-daily from once-daily and increasing the number of subjects in both studies.

 

●Company secured long term, exclusive supply of the only fully GMP grade active ingredient in QRX003.

 

●On September 6th, Quoin signed its ninth commercial agreement for QRX003, increasing the number of partnered countries to sixty-one.

 

Financial Highlights

 

●Quoin had approximately $14.0 million in cash, cash equivalents and marketable securities as of September 30, 2023.

 

●Net loss for the quarter ended September 30, 2023 was approximately $2.1 million compared to approximately $2.3 million for the quarter ended September 30, 2022, and net loss for the nine months ended September 30, 2023 was $7.2 million compared to $7.2 million for the nine months ended September 30, 2022.

 

●Investors are encouraged to read the Company’s Quarterly 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 September 30, 2023.

 

Quoin will host a conference call and webcast at 8:30am ET on Thursday, November 9, 2023. The call will include a discussion of third quarter 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 call webcast will be available at: https://event.choruscall.com/mediaframe/webcast.html?webcastid=sPhSaNGJ.

 

About Quoin Pharmaceuticals Ltd.

 

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.

 

Cautionary Note Regarding Forward Looking Statements


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. 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, 2022 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.

 

For further information:

 

PCG Advisory
Stephanie Prince
sprince@pcgadvisory.com
(646) 863-6341

 

 

-Tables Follow-

 

 

 

 

QUOIN PHARMACEUTICALS LTD.

 

Consolidated Balance Sheets

 

   September 30,   December 31, 
   2023   2022 
    (Unaudited)      
ASSETS          
Current assets:          
Cash and cash equivalents  $3,163,426   $2,860,628 
Investments   10,818,051    9,992,900 
Prepaid expenses   159,851    516,584 
Total current assets   14,141,328    13,370,112 
           
Prepaid expenses - long term   300,000    383,390 
Intangible assets, net   626,529    704,561 
Total assets  $15,067,857   $14,458,063 
           
LIABILITIES AND SHAREHOLDERS' EQUITY          
Current liabilities:          
Accounts payable  $239,978   $605,600 
Accrued expenses   2,594,199    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   4,580,428    3,527,556 
           
Due to officers - long term   3,073,733    3,523,733 
Total liabilities  $7,654,161   $7,051,289 
           
Commitments and contingencies          
           
Shareholders' equity:          
Ordinary shares, no par value per share, 8,333,334 ordinary shares authorized - 987,220 (987,220 ADS's) ordinary shares issued and outstanding at September 30, 2023 and 403,887 (403,887 ADS's) at December 31, 2022  $-   $- 
           
Treasury stock, 45 ordinary shares   (2,932,000)   (2,932,000)
Additional paid in capital   54,499,138    47,855,521 
Accumulated deficit   (44,153,442)   (37,516,747)
Total shareholders' equity   7,413,696    7,406,774 
           
Total liabilities and shareholders' equity  $15,067,857   $14,458,063 

 

 

 

 

QUOIN PHARMACEUTICALS LTD.

 

Statements of Operations (Unaudited)

 

   Nine months ended September 30,   Three months ended September 30, 
   2023   2022   2023   2022 
Operating expenses                    
General and administrative  $4,685,241   $5,112,002   $1,366,464   $1,582,059 
Research and development   2,475,596    2,059,769    758,759    745,506 
                     
Total operating expenses   7,160,837    7,171,771    2,125,223    2,327,565 
                     
Other (income) and expenses                    
Forgiveness of accounts payable   -    (416,000)   -    - 
Warrant liability (income) expense   -    (77,237)   -    - 
Unrealized loss (gain)   11,926    3,053    (2,119)   3,053 
Interest income   (536,068)   (15,132)   (196,425)   (15,132)
Interest and financing expense   -    714,081    -    714,081 
Total other (income) expense   (524,142)   208,765    (198,544)   702,002 
Net loss  $(6,636,695)  $(7,380,536)  $(1,926,679)  $(3,029,567)
Deemed dividend on warrant modification   -    (65,266)   -    (65,266)
Net loss attributable to shareholders  $(6,636,695)  $(7,445,802)  $(1,926,679)  $(3,094,833)
                     
Loss per ADS                    
Loss per ADS                    
Basic  $(7.61)  $(55.79)  $(1.95)  $(11.28)
Fully-diluted  $(7.61)  $(55.79)  $(1.95)  $(11.28)
                     
Weighted average number of ADS's outstanding                    
Basic   871,835    133,450    987,220    274,317 
Fully-diluted   871,835    133,450    987,220    274,317 

 

 

 

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Cover
Nov. 08, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 08, 2023
Entity File Number 001-37846
Entity Registrant Name QUOIN PHARMACEUTICALS LTD.
Entity Central Index Key 0001671502
Entity Tax Identification Number 92-2593104
Entity Incorporation, State or Country Code L3
Entity Address, Address Line One 42127 Pleasant Forest Court
Entity Address, City or Town Ashburn
Entity Address, State or Province VA
Entity Address, Postal Zip Code 20148-7349
City Area Code 703
Local Phone Number 980-4182
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security American Depositary Shares, each representing one (1) Ordinary Share, no par value per share
Trading Symbol QNRX
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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