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Quoin Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2026 Financial Results

(Very Positive)
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Quoin Pharmaceuticals (NASDAQ: QNRX) reported multiple pipeline milestones and second quarter 2026 results for the period ended June 30, 2026. The FDA granted conditional approval of QYLEKI™ as the proposed brand name for QRX003 for Netherton Syndrome, which holds Orphan Drug, Fast Track and Rare Pediatric Disease designations. Quoin also reported a positive clinical update from its ongoing pediatric compassionate use program and received a U.S. Notice of Allowance for a patent covering a combination treatment for Netherton Syndrome.

For Peeling Skin Syndrome, Quoin submitted the first-ever IND, which the FDA cleared in July 2026, enabling a planned Phase 2/3 study to start in 2H 2026. The QRX009 topical rapamycin platform is advancing toward investigator-led clinical studies in several indications. Quoin reported cash, cash equivalents and investments of approximately $10.8 million and a quarterly net loss of about $5.4 million, and believes existing cash will fund operations into 2027.

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Positive

  • FDA conditional brand-name approval for QYLEKI™ (QRX003) in Netherton Syndrome on June 23, 2026
  • First-ever PSS IND submitted June 2, 2026 and FDA-cleared July 9, 2026 for planned Phase 2/3 study starting 2H 2026
  • U.S. patent Notice of Allowance on June 30, 2026 for combination treatment for Netherton Syndrome (Application No. 18/428,570)
  • QRX009 topical rapamycin platform progressing toward investigator-led clinical testing in multiple rare dermatologic indications
  • Cash, cash equivalents and investments of about $10.8 million at June 30, 2026; company believes funding extends operations into 2027

Negative

  • Quarterly net loss widened to approximately $5.37 million from $3.70 million year over year
  • Six-month net loss increased to about $10.37 million from $7.51 million for the prior-year period
  • Total assets declined to roughly $11.97 million at June 30, 2026 from $20.39 million at December 31, 2025
  • Shareholders’ equity decreased to about $3.93 million from $13.12 million over the same period
  • Ordinary shares outstanding rose to 70.3 million (2,008,418 ADSs) from 52.4 million (1,498,325 ADSs), indicating dilution
  • Total operating expenses for Q2 2026 increased to $5.47 million from $3.79 million, driven largely by higher R&D spending

News Explained

The newly reported June 30, 2026 balance sheet shows 2,008,418 ADS outstanding, versus 1,498,325 ADS at December 31, 2025, alongside $3,845,606 cash, $6,954,476 investments, and $6,613,158 in current liabilities; the disclosure therefore adds a larger issued share base and these obligations to the existing summary.

Market reaction after 2Q26 earnings report: QNRX -17.36%

-17.36% $5.00 1.8x vol
15m delay
-17.36% Vs previous close
-5.8% Trough in 2 min
$5.00 Last Price
$4.70 $6.56 Day Range
$9.78M Market Cap
1.8x Rel. Volume

Following this news, QNRX has declined 17.36%, reflecting a significant negative market reaction. Argus tracked a trough of -5.8% from its starting point during tracking. Our momentum scanner has triggered 8 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $5.00. Trading volume is above average at 1.8x the average, suggesting increased trading activity.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Market Context

TOVX was up 1.7391303554177284% in the momentum scanner, but only one peer appeared there. That limi...
Analysis

TOVX was up 1.7391303554177284% in the momentum scanner, but only one peer appeared there. That limited signal frames the update alongside its quarterly loss and an S-3 resale registration that would not provide company proceeds.

Key Figures

QYLEKI conditional approval date: June 23, 2026 PSS IND clearance date: July 9, 2026 Planned study initiation: 2H 2026 +5 more
8 metrics
QYLEKI conditional approval date June 23, 2026 Proposed brand name for QRX003
PSS IND clearance date July 9, 2026 FDA clearance subsequent to quarter end
Planned study initiation 2H 2026 Phase 2/3 study for Peeling Skin Syndrome
Cash and marketable securities $10.8 million As of June 30, 2026
Quarterly net loss $5,371,042 Three months ended June 30, 2026
Prior-year quarterly net loss $3,695,938 Three months ended June 30, 2025
Six-month net loss $10,368,777 Six months ended June 30, 2026
Prior-year six-month net loss $7,508,117 Six months ended June 30, 2025

Previous Earnings Reports

5 past events · Latest: May 07 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
May 07 Q1 2026 earnings Positive -0.9% Regulatory progress and cash runway were followed by a -0.93% reaction.
Mar 26 FY2025 earnings Negative -18.4% Private placement and clinical updates were followed by an -18.39% reaction.
Nov 06 Q3 2025 earnings Negative -11.2% Financing activity and clinical progress were followed by an -11.19% reaction.
Aug 07 Q2 2025 earnings Positive -6.2% Positive clinical and regulatory updates were followed by a -6.24% reaction.
May 13 Q1 2025 earnings Positive +3.9% Clinical progress and expanded studies accompanied a 3.92% reaction.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

The five tag-specific earnings events averaged a -6.57% 24-hour move; four were followed by declines, including events with positive operational updates.

Key Terms

orphan drug designation, fast track, notice of allowance, serine protease inhibitor
4 terms
orphan drug designation regulatory
"QRX003 holds Orphan Drug Designation in the United States"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
fast track regulatory
"along with Fast Track and Rare Pediatric Disease Designations"
A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.
notice of allowance regulatory
"issued a Notice of Allowance for U.S. Patent Application"
A notice of allowance is an official confirmation from a patent office that a patent application has met all necessary requirements and is approved for granting. It signals that the invention is likely to receive legal protection soon, which can be important for investors considering the value and exclusivity of a new product or technology. Think of it as a green light indicating that the invention is on track to become legally protected.
serine protease inhibitor medical
"using a topical serine protease inhibitor together with"
A serine protease inhibitor is a drug or molecule that blocks a type of enzyme—called a serine protease—that cuts other proteins as part of normal body processes like blood clotting, digestion, immune response or viral replication. Investors care because these inhibitors can be developed into medicines that alter disease pathways; their success affects a company’s clinical progress, regulatory risk and potential market value much like a key that can lock an important biological ‘scissor’ from doing damage or causing disease.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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– Receives FDA Conditional Approval of QYLEKI™ as the Proposed Brand Name for QRX003 for Netherton Syndrome

– Reports Positive Clinical Update from Ongoing Pediatric Compassionate Use Program in Netherton Syndrome

– Receives U.S. Notice of Allowance for a Patent Covering a Combination Treatment for Netherton Syndrome

– Submits First-Ever IND for Peeling Skin Syndrome; FDA Clearance Received Subsequent to Quarter End, Enabling First Company-Sponsored Phase 2/3 Study to Initiate in 2H 2026

– Advances QRX009 Topical Rapamycin Platform Toward Clinical Testing in a Number of Indications

ASHBURN, Va., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced recent corporate achievements and provided an update on its progress for the second quarter ended June 30, 2026.

“The second quarter was a highly productive period across both of our delivery technology platforms,” said Dr. Michael Myers, Chief Executive Officer and Co-Founder of Quoin Pharmaceuticals. “Our Ichthyosis focused platform, QRX003 continued to advance toward pivotal development in Netherton Syndrome while expanding into additional rare dermatologic indications, highlighted by FDA clearance of the first-ever formal clinical study for a potential Peeling Skin Syndrome therapy. At the same time, our topical rapamycin platform, QRX009, remains on track to enter the clinic in a number of indications which have no or limited approved treatments. With QRX003 approaching Phase 3 and QRX009 advancing toward clinical testing, we believe Quoin has built one of the broadest development pipelines focused exclusively on rare dermatologic diseases.”

QRX003 (QYLEKI™) – Netherton Syndrome

QYLEKI™ Brand Name Conditionally Approved by FDA. On June 23, 2026, the FDA conditionally approved QYLEKI™ as the proposed brand name for QRX003 for Netherton Syndrome. QRX003 holds Orphan Drug Designation in the United States, the European Union, and Japan, along with Fast Track and Rare Pediatric Disease Designations from the FDA.

Positive Pediatric Compassionate Use Program Update. On June 16, 2026, Quoin reported a positive clinical update from its ongoing Pediatric Compassionate Use Program.

U.S. Patent Notice of Allowance Received for Netherton Syndrome Program. On June 30, 2026, the U.S. Patent and Trademark Office issued a Notice of Allowance for U.S. Patent Application No. 18/428,570, “Combination Treatment for Netherton Syndrome.” The allowed claims cover a method of treating Netherton Syndrome using a topical serine protease inhibitor together with an anti-inflammatory agent, including in patients carrying SPINK5 mutations, and add to the Company’s U.S. intellectual property position for QRX003.

QRX003 – Peeling Skin Syndrome

First-Ever IND for Peeling Skin Syndrome Submitted and Cleared. On June 2, 2026, Quoin submitted the first-ever IND to the FDA for Peeling Skin Syndrome (PSS), the second indication for QRX003. Subsequent to quarter end, on July 9, 2026, the FDA cleared the IND and expressed no safety concerns regarding study design or duration of dosing. The planned Phase 2/3 study, the first ever company-sponsored formal clinical study for the disease, is expected to enroll pediatric and adult patients in the United States and Europe and to initiate in the second half of 2026. There is currently no approved treatment for PSS.

QRX009 – Topical Rapamycin Platform

QRX009 Advancing Toward Clinical Testing. Quoin continues to advance its proprietary topical rapamycin platform toward clinical testing. Investigator-led studies are planned across several indications, including Pachyonychia Congenita, Gorlin Syndrome, and Tuberous Sclerosis Complex, and the Company plans to submit an IND to the FDA for an additional indication before the end of 2026.

Financial Highlights

Quoin had approximately $10.8 million in cash, cash equivalents, and marketable securities as of June 30, 2026. The Company believes its current cash position will fund operations into 2027.

Net loss for the quarter ended June 30, 2026, was approximately $5.4 million, compared to approximately $3.7 million for the quarter ended June 30, 2025. Net loss for the six months ended June 30, 2026, was approximately $10.4 million, compared to approximately $7.5 million for the six months ended June 30, 2025.

Investors are encouraged to read the Company’s Quarterly Report on Form 10-Q when filed with the Securities and Exchange Commission, which will contain additional details about Quoin’s financial results as of and for the period ended June 30, 2026.

About Quoin Pharmaceuticals Ltd.

Quoin Pharmaceuticals Ltd. is a late 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 is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, microcystic lymphatic malformations, venous malformations, angiofibromas and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.

Forward-Looking Statements

The Company cautions that statements in this press release 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. This press release contains forward-looking statements. 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 relating to: FDA clearance enabling first company-sponsored Phase 2/3 study to initiate in 2H 2026, continuing to advance QRX003 toward pivotal development in Netherton Syndrome while expanding into additional rare dermatologic indications; QRX009 remaining on track to enter the clinic in a number of indications which have no or limited approved treatments; QRX003 approaching Phase 3 and QRX009 advancing toward clinical testing, planned Phase 2/3 study for Peeling Skin Syndrome being expected to enroll pediatric and adult patients in the United States and Europe and to initiate in the second half of 2026, Quoin continuing to advance its proprietary topical rapamycin platform toward clinical testing; investigator-led studies being planned across several indications, including Pachyonychia Congenita, Gorlin Syndrome, and Tuberous Sclerosis Complex, the Company submitting an IND to the FDA for an additional indication before the end of 2026, the Company’s current cash position funding operations into 2027, and Quoin’s products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma 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 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 including, but not limited to, the Company’s ability to pursue its regulatory strategy; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company’s ability to complete clinical trials on time and achieve desired results and benefits as expected; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and in other filings the Company has made and may make with the SEC in the future. 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, contact:

Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com

Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341

Tables to follow

QUOIN PHARMACEUTICALS, LTD.    
Consolidated Balance Sheets    
        
     June 30, December 31,
      2026   2025 
        
ASSETS  (unaudited)  
 Current assets:    
  Cash and cash equivalents $3,845,606  $3,818,096 
  Investments  6,954,476   14,927,165 
  Prepaid expenses and other current assets  836,146   1,261,974 
   Total current assets  11,636,228   20,007,235 
  Intangible assets, net  333,334   383,334 
   Total assets $11,969,562  $20,390,569 
        
LIABILITIES AND SHAREHOLDERS' EQUITY    
 Current liabilities:    
  Accounts payable $3,109,517  $1,262,222 
  Accrued expenses  1,757,390   2,538,457 
  Accrued interest and financing expense  1,146,251   1,146,251 
  Due to officers - short term  600,000   600,000 
   Total current liabilities  6,613,158   5,546,930 
        
  Due to officers - long term  1,423,733   1,723,733 
   Total liabilities $8,036,891  $7,270,663 
        
  Commitments and contingencies    
        
 Shareholders' equity:    
  Ordinary shares, no par value per share, 5,000,000,000 $-  $- 
   authorized at June 30, 2026 and December 31, 2025, respectively - 70,294,615 (2,008,418 ADS's) ordinary shares issued and outstanding at June 30, 2026 and 52,441,360 (1,498,325 ADS's) ordinary shares issued and outstanding at December 31, 2025    
       
  Accumulated other comprehensive loss  (582)  (613)
  Additional paid in capital  85,272,477   84,090,966 
  Accumulated deficit  (81,339,224)  (70,970,447)
   Total shareholders' equity  3,932,671   13,119,906 
        
   Total liabilities and shareholders' equity $11,969,562  $20,390,569 



QUOIN PHARMACEUTICALS, LTD.       
Consolidated Statement of Operations & Other Comprehensive Loss (Unaudited)    
           
           
    Three months ended June 30, Six months ended June 30,
     2026   2025   2026   2025 
           
           
Operating expenses       
 General and administrative$1,846,406  $1,742,594  $3,543,854  $3,325,632 
 Research and development 3,627,168   2,050,585   7,060,930   4,424,724 
           
  Total operating expenses 5,473,574   3,793,179   10,604,784   7,750,356 
           
Other (income) and expenses       
 Unrealized (gain) loss (1,585)  6,004   11,715   5,878 
 Realized and accrued interest income (100,947)  (103,245)  (247,722)  (248,117)
  Total other income (102,532)  (97,241)  (236,007)  (242,239)
           
Net loss $(5,371,042) $(3,695,938) $(10,368,777) $(7,508,117)
           
Other comprehensive loss       
 Foreign currency translation (423)  -   31   - 
Comprehensive loss$(5,371,465) $(3,695,938) $(10,368,746) $(7,508,117)
           
Loss per ADS       
Loss per ADS       
 Basic $(1.90) $(6.28) $(3.66) $(12.79)
 Fully-diluted$(1.90) $(6.28) $(3.66) $(12.79)
           
Weighted average number of ADS's outstanding      
 Basic  2,832,915   588,166   2,831,948   587,253 
 Fully-diluted 2,832,915   588,166   2,831,948   587,253 




FAQ

What were Quoin Pharmaceuticals (QNRX) key clinical milestones in Q2 2026?

Quoin reported FDA conditional approval of QYLEKI™ as QRX003’s proposed brand name, a positive pediatric compassionate use update in Netherton Syndrome, and FDA clearance of the first-ever IND for Peeling Skin Syndrome. According to Quoin, a Phase 2/3 PSS trial is planned for 2H 2026.

How much cash did Quoin Pharmaceuticals (QNRX) report for the quarter ended June 30, 2026?

Quoin reported approximately $10.8 million in cash, cash equivalents and marketable securities as of June 30, 2026. According to Quoin, this cash position is expected to fund operations into 2027, supporting ongoing development of QRX003, QRX009 and related clinical programs.

What was Quoin Pharmaceuticals (QNRX) net loss for Q2 2026?

Quoin reported a net loss of about $5.37 million for the quarter ended June 30, 2026, compared with approximately $3.70 million a year earlier. According to Quoin, total operating expenses rose to $5.47 million, mainly from increased research and development spending.

What does the FDA’s conditional approval of QYLEKI™ mean for Quoin Pharmaceuticals (QNRX)?

The FDA granted conditional approval of QYLEKI™ as the proposed brand name for QRX003 in Netherton Syndrome on June 23, 2026. According to Quoin, QRX003 also holds Orphan Drug, Fast Track and Rare Pediatric Disease designations in key markets, strengthening its regulatory profile.

What are Quoin Pharmaceuticals (QNRX) plans for Peeling Skin Syndrome clinical development?

Quoin submitted the first-ever IND for Peeling Skin Syndrome on June 2, 2026, and the FDA cleared it July 9, 2026. According to Quoin, this enables a company-sponsored Phase 2/3 study in pediatric and adult patients in the U.S. and Europe starting in 2H 2026.

How is Quoin Pharmaceuticals (QNRX) progressing its QRX009 topical rapamycin platform?

Quoin continues advancing its QRX009 topical rapamycin platform toward clinical testing, with investigator-led studies planned in several indications. According to Quoin, these include Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, and an additional IND filing is planned before the end of 2026.